U.S. patent application number 16/705493 was filed with the patent office on 2020-04-09 for inline storage pouches for use with body fluids.
The applicant listed for this patent is KCI Licensing, Inc.. Invention is credited to Christopher Brian LOCKE, Benjamin Andrew PRATT, Elliott James RIDER.
Application Number | 20200108235 16/705493 |
Document ID | / |
Family ID | 45952671 |
Filed Date | 2020-04-09 |
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United States Patent
Application |
20200108235 |
Kind Code |
A1 |
LOCKE; Christopher Brian ;
et al. |
April 9, 2020 |
INLINE STORAGE POUCHES FOR USE WITH BODY FLUIDS
Abstract
Inline storage pouches and systems for receiving and retaining
body fluids from an animal are presented. The inline storage pouch
include a flexible pouch body has an interior portion with a fluid
storage material disposed within the interior portion. In addition
to receiving body fluids, the inline storage pouch may fluidly
couple a pressure sensing conduit between a first port and a second
port using a first bypass conduit. The first port may be a
patient-port interface. The second port may be a device-port
interface. Multiple sensors and bypass conduits may be included and
associated with a microprocessor that is configured to locate
blockages or determine when the inline storage pouch is full.
Another inline storage pouch has two chambers and receives and
discharges fluids from a pouch connector. Other pouches, systems,
and methods are presented herein.
Inventors: |
LOCKE; Christopher Brian;
(Bournemouth, GB) ; RIDER; Elliott James; (Acklam,
GB) ; PRATT; Benjamin Andrew; (Poole, GB) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
KCI Licensing, Inc. |
San Antonio |
TX |
US |
|
|
Family ID: |
45952671 |
Appl. No.: |
16/705493 |
Filed: |
December 6, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15220017 |
Jul 26, 2016 |
10532194 |
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16705493 |
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13442519 |
Apr 9, 2012 |
9433712 |
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15220017 |
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61543558 |
Oct 5, 2011 |
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61529709 |
Aug 31, 2011 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
Y10T 29/49826 20150115;
A61M 2205/3344 20130101; A61M 1/0086 20140204; A61M 1/0088
20130101; A61F 2013/00536 20130101; A61M 1/0027 20140204; A61M
27/00 20130101; A61M 2205/50 20130101 |
International
Class: |
A61M 27/00 20060101
A61M027/00; A61M 1/00 20060101 A61M001/00 |
Claims
1.-46. (canceled)
47. A method of manufacturing an inline storage pouch for use with
body fluids from an animal, the method comprising: forming a
flexible pouch body having a first wall, a second wall, and a
partitioning wall whereby an interior portion is formed having a
first chamber and a second chamber, wherein the flexible pouch body
has a proximal end and a distal end; disposing a first manifolding
material within the first chamber; disposing a fluid storage
material within the second chamber; coupling a pouch connector to
the flexible pouch body at the proximal end, wherein the pouch
connector fluidly couples fluids received from the animal to the
second chamber and fluidly couples reduced pressure received from a
reduced-pressure source to the first chamber; wherein the
partitioning wall of the flexible pouch body has a proximal end and
a distal end; forming an exudate aperture proximate the proximal
end of the partitioning wall; disposing a portion of the pouch
connector through the exudate aperture; sealing the partitioning
wall to the portion of the pouch connector extending through the
exudate aperture; and forming a return aperture proximate the
distal end of the partitioning wall for allowing fluid flow from
the second chamber into the first chamber.
48. The method of claim 47, wherein the pouch connector comprises:
a connector body formed with an exudate chamber having an intake
port for receiving the fluids from the animal and an outlet for
discharging the fluids from the animal, the connector body also
formed with a reduced-pressure chamber having an intake port for
receiving fluids and an outlet port for discharging fluids, the
outlet port of the reduced-pressure chamber is for receiving the
reduced pressure from the reduced-pressure source, wherein the
exudate chamber and reduced-pressure chamber are fluidly isolated
from each other within the connector, and a displacement conduit
fluidly coupled to the outlet port and the second chamber for
delivering the fluids from the exudate chamber to the second
chamber; and fluidly coupling the intake port of the
reduced-pressure chamber to the first chamber for delivering
reduced pressure to the first chamber.
49. The method of claim 48, further comprising forming a plurality
of offsets on the connector body proximate to the intake port of
the reduced-pressure chamber.
50. (canceled)
51. (canceled)
52. A connector for an inline storage pouch having first chamber
and a second chamber, the first chamber and the second chamber
being fluidly isolated from each other, the connector comprising: a
connector body having an exudate chamber and a reduced-pressure
chamber fluidly isolated from each other; an first intake port
fluidly coupled to the exudate chamber; an first outlet port
fluidly coupled to the exudate chamber; an second intake port
fluidly coupled to the reduced-pressure chamber and the first
chamber; an second outlet port fluidly coupled to the
reduced-pressure chamber; and a displacement conduit fluidly
coupled to the first outlet port and the second chamber.
53. The connector of claim 52, wherein the connector further
comprises a plurality of offsets on the connector body proximate to
the second intake port.
54. The connector of claim 52, wherein the first intake port is
substantially parallel to the second outlet port.
55. The connector of claim 54, wherein the inline storage pouch has
a longitudinal axis that is substantially parallel to the axis of
the first intake port.
56. The connector of claim 52, wherein the first intake port
comprises a tube connector and the second outlet port comprises a
tube connector.
57. The connector of claim 52, further comprising: a plurality of
offsets on the connector body proximate to the second intake port;
wherein the first intake port is substantially parallel to the
second outlet port; and wherein the inline storage pouch has a
longitudinal axis that is substantially perpendicular to an axis of
the first outlet port.
58. A fluid storage pouch for a reduced-pressure therapy, the fluid
storage pouch comprising: a first wall; a second wall coupled to
the first wall to form an interior portion between the first wall
and the second wall; an absorbent disposed in the interior portion;
a manifolding material disposed in the interior portion and at
least partially surrounding the absorbent; a first port coupled at
least one of the first wall and the second wall and fluidly coupled
to the interior portion, the first port configured to be fluidly
coupled to a fluid reception device; and a second port coupled to
at least one of the first wall and the second wall and fluidly
coupled to the interior portion, the second port configured to be
fluidly coupled to a reduced-pressure source.
59. The fluid storage pouch of claim 58, wherein the manifolding
material comprises a first wicking member and a second wicking
member coupled to the first wicking member to enclose the
absorbent.
60. The fluid storage pouch of claim 59, wherein a peripheral edge
of the first wicking member is coupled to a peripheral edge of the
second wicking member.
61. The fluid storage pouch of claim 60, wherein the peripheral
edge of the first wicking member overlaps the peripheral edge of
the second wicking member.
62. The fluid storage pouch of claim 61, wherein the peripheral
edge of the first wicking member is in fluid communication with the
peripheral edge of the second wicking member.
63. The fluid storage pouch of claim 58, wherein the manifolding
material comprises a non-woven.
64. The fluid storage pouch of claim 58, wherein the manifolding
material comprises an open-cell foam.
65. The fluid storage pouch of claim 58, further comprising a
partitioning wall disposed in the interior portion, the
partitioning wall forming a first chamber and a second chamber.
66. The fluid storage pouch of claim 65, wherein the manifolding
material is a first manifolding material, the first manifolding
material and the absorbent disposed in the first chamber, and the
fluid storage pouch further comprising a second manifolding
material disposed in the second chamber.
67. The fluid storage pouch of claim 66, wherein the first port is
fluidly coupled to the first chamber, the second port is fluidly
coupled to the second chamber, and the first chamber is in fluid
communication with the second chamber.
68. The fluid storage pouch of claim 67, further comprising: a
return aperture disposed in the partitioning wall, the first
chamber in fluid communication with the second chamber through the
return aperture; and a filter assembly disposed in the return
aperture, the filter assembly comprising: a primary filter, a
secondary filter, and a manifold disposed between the primary
filter and the secondary filter.
69. The fluid storage pouch of claim 58, further comprising a
reduced-pressure indicated coupled to the first port and in fluid
communication with the interior portion, the reduced-pressure
indicator comprising: an indicator member; and a collapsible wall
coupled to the indicator member, the collapsible wall configured to
collapse in response to a reduced pressure in excess of a threshold
pressure.
Description
RELATED APPLICATIONS
[0001] The present application is a divisional of U.S. patent
application Ser. No. 15/220,017, titled "INLINE STORAGE POUCHES FOR
USE WITH BODY FLUIDS," filed 26 Jul. 2016, which is a divisional of
U.S. patent application Ser. No. 13/442,519, entitled "INLINE
STORAGE POUCHES FOR USE WITH BODY FLUIDS," filed on 9 Apr. 2012,
which claims the benefit, under 35 USC .sctn. 119(e), of the
filings of U.S. Provisional Patent Application Ser. No. 61/543,558,
entitled "INLINE STORAGE POUCHES FOR USE WITH BODY FLUIDS," filed
on 5 Oct. 2011, which is incorporated herein by reference for all
purposes; and U.S. Provisional Patent Application Ser. No.
61/529,709, entitled "EVAPORATIVE FLUID POUCH AND SYSTEMS FOR USE
WITH BODY FLUIDS," filed 31 Aug. 2011, which is incorporated herein
by reference for all purposes.
TECHNICAL FIELD
[0002] The present disclosure relates generally to medical
treatment systems for treating tissue sites that produce liquids,
such as exudate, and for processing body fluids. More particularly,
but not by way of limitation, the present disclosure relates to
inline storage pouches, systems, and methods for receiving and
storing liquids from an animal.
BACKGROUND
[0003] Caring for wounds is important in the healing process.
Wounds often produce considerable liquids, e.g., exudate. Medical
dressings are often used in wound care to address the production of
liquids from the wound. If not properly addressed, liquids at the
wound can lead to infection or maceration at or near the wound. As
used throughout this document, "or" does not require mutual
exclusivity. Wound dressings may be used alone or as an aspect of
applying reduced pressure to a tissue site.
[0004] Clinical studies and practice have shown that providing
reduced pressure in proximity to a tissue site augments and
accelerates the growth of new tissue at the tissue site.
[0005] 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.
SUMMARY
[0006] According to an illustrative embodiment, an inline storage
pouch for use with body fluids from an animal includes a flexible
pouch body having an interior portion, a fluid storage material
disposed within the interior portion, and a first port. As used
herein, it should be understood that the term "animal" includes
humans. The first port is formed on the flexible pouch body and is
configured to connect to a first multi-lumen conduit extending from
the flexible pouch body to the animal. The first multi-lumen
conduit has at least one sensing lumen and at least one reduced
pressure lumen. The inline storage pouch also includes a second
port formed on the flexible pouch body. The second port is
configured to fluidly connect to a second multi-lumen conduit
extending from the flexible pouch body to a reduced pressure
source. The second multi-lumen conduit has at least one sensing
lumen and at least one reduced pressure lumen.
[0007] The inline storage pouch also includes a first bypass
conduit disposed within and fluidly isolated from the interior
portion of the flexible pouch body. The first bypass conduit has a
first end and a second end. The first end of the first bypass
conduit is fluidly coupled to the at least one sensing lumen of the
first multi-lumen conduit. The second end of the first bypass
conduit is fluidly coupled to the at least one sensing lumen of the
second multi-lumen conduit. The first port may be a patient-port
interface. The second port may be a device-port interface.
[0008] According to another illustrative embodiment, a system for
treating a tissue site on an animal with reduced pressure includes
a wound dressing for disposing proximate to the tissue site for
providing reduced pressure to the tissue site. The wound dressing
has a reduced-pressure interface. The reduced-pressure interface
includes a reduced-pressure-supply conduit and a
pressure-assessment conduit. The system further includes an inline
storage pouch, a first multi-lumen conduit, and a second
multi-lumen conduit. The first multi-lumen conduit has at least one
sensing lumen and at least one reduced pressure lumen. The at least
one sensing lumen of the first multi-lumen conduit is fluidly
coupled to the pressure-assessment conduit of the reduced-pressure
interface. The at least one reduced-pressure lumen of the first
multi-lumen conduit is fluidly coupled to the
reduced-pressure-supply conduit.
[0009] The inline storage pouch includes a flexible pouch body
having an interior portion, a fluid storage material disposed
within the interior portion, a first port formed on the flexible
pouch body configured to connect to the first multi-lumen conduit,
and a second port formed on the flexible pouch body. The second
port is configured to fluidly couple to a second multi-lumen
conduit that extends from the flexible pouch body to a reduced
pressure source. The second multi-lumen conduit has at least one
sensing lumen and at least one reduced pressure lumen. The inline
storage pouch also includes a first bypass conduit disposed within
and fluidly isolated from the interior portion of the flexible
pouch body. The bypass conduit has a first end and a second end.
The first end of the bypass conduit is fluidly coupled to the at
least one sensing lumen of the first multi-lumen conduit. The
second end of the bypass conduit is fluidly coupled to the at least
one sensing lumen of the second multi-lumen conduit.
[0010] The system also includes a reduced-pressure source and a
first pressure-sensing unit. The at least one reduced pressure
lumen of the second multi-lumen conduit is fluidly coupled to the
reduced-pressure source. The at least one sensing lumen of the
second multi-lumen conduit is fluidly coupled to the first-pressure
sensing device.
[0011] According to another illustrative embodiment, a method of
storing liquids from an animal includes providing an inline storage
pouch. The inline storage pouch includes a flexible pouch body
having an interior portion, a fluid storage material disposed
within the interior portion, and a first port. The first port is
formed on the flexible pouch body. The first port is configured to
connect to a first multi-lumen conduit that extends from the
flexible pouch body to the animal. The first multi-lumen conduit
has at least one sensing lumen and at least one reduced pressure
lumen.
[0012] The inline storage pouch also includes a second port formed
on the flexible pouch body. The second port is configured to
fluidly connect to a second multi-lumen conduit that extends from
the flexible pouch body to a reduced pressure source. The second
multi-lumen conduit has at least one sensing lumen and at least one
reduced pressure lumen. The inline storage pouch also includes a
first bypass conduit disposed within and fluidly isolated from the
interior portion of the flexible pouch body. The first bypass
conduit has a first end and a second end. The first end of the
first bypass conduit is fluidly coupled to the at least one sensing
lumen of the first multi-lumen conduit. The second end of the first
bypass conduit is fluidly coupled to the at least one sensing lumen
of the second multi-lumen conduit.
[0013] The method also includes coupling the at least one reduced
pressure lumen of the first multi-lumen conduit to the animal to
receive the liquids from the animal and coupling the at least one
sensing lumen of the first multi-lumen conduit to the animal to
receive the pressure from the animal proximate to where the liquids
are removed. The method also includes providing reduced pressure to
the at least one reduced pressure lumen of the second multi-lumen
conduit and coupling a pressure-sensing unit to the at least one
sensing lumen of the second multi-lumen conduit.
[0014] According to another illustrative embodiment, an inline
storage pouch for use with body fluids from an animal includes a
flexible pouch body having a first wall, a second wall, and a
partitioning wall whereby an interior portion is formed. The
interior portion has a first chamber and a second chamber. The
flexible pouch body has a proximal end and a distal end. The inline
storage pouch also includes a first manifolding material disposed
within the first chamber and a fluid storage material disposed
within the second chamber. The inline storage pouch further
includes a pouch connector coupled to the flexible pouch body at
the proximal end. The pouch connector fluidly couples fluids
received from the animal to the second chamber and fluidly couples
reduced pressure received from a reduced-pressure source to the
first chamber. The partitioning wall of the flexible pouch body has
a proximal end and a distal end, and the proximal end of the
partitioning wall has an exudate aperture for receiving a portion
of the pouch connector. The distal end of the partitioning wall has
a return aperture for allowing fluid flow from the second chamber
to the first chamber.
[0015] According to another illustrative embodiment, a pouch
connector for use with an inline storage pouch includes a connector
body formed with an exudate chamber having an intake port for
receiving the fluids from the animal and an outlet for discharging
the fluids. The connector body is also formed with a
reduced-pressure chamber having an intake port for receiving fluids
and an outlet port for discharging fluids. The outlet port of the
reduced-pressure chamber is for receiving the reduced pressure from
the reduced-pressure source. The exudate chamber and
reduced-pressure chamber are fluidly isolated from each other
within the pouch connector. The pouch connector also includes a
displacement conduit fluidly coupled to the outlet port of the
exudate chamber for delivering the fluids from the exudate chamber
to a portion of the inline storage pouch. The intake port of the
reduced-pressure chamber is fluidly coupled to another portion of
the inline storage pouch for delivering reduced pressure
thereto.
[0016] According to another illustrative embodiment, a method of
manufacturing an inline storage pouch for use with body fluids from
an animal includes forming a flexible pouch body having a first
wall, a second wall, and a partitioning wall whereby an interior
portion is formed having a first chamber and a second chamber. The
flexible pouch body has a proximal end and a distal end. The method
further includes disposing a first manifolding material within the
first chamber, disposing a fluid storage material within the second
chamber, and coupling a pouch connector to the flexible pouch body
at the proximal end. The pouch connector fluidly couples fluids
from the animal to the second chamber and fluidly couples reduced
pressure received from a reduced-pressure source to the first
chamber. The partitioning wall of the flexible pouch body has a
proximal end and a distal end. The method further includes forming
an exudate aperture proximate the proximal end of the partitioning
wall, disposing a portion of the pouch connector through the
exudate aperture, and forming a return aperture proximate the
distal end of the partitioning wall for allowing fluid flow from
the second chamber into the first chamber.
[0017] Other aspects, 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
[0018] FIG. 1 is a schematic, perspective view of an illustrative
system for treating a tissue site on an animal with reduced
pressure that involves storing liquids in an inline storage
pouch;
[0019] FIG. 2 is a schematic diagram, with a portion shown in cross
section and a portion in plan view, of an illustrative system for
treating a tissue site on an animal with reduced pressure that
involves storing liquids in an inline storage pouch;
[0020] FIG. 3 is a schematic, elevation view of an illustrative
patient-port interface;
[0021] FIG. 4 is a schematic, perspective view showing a
pouch-facing side of the patient-port interface of FIG. 3;
[0022] FIG. 5 is a schematic, perspective view showing a first side
(opposite the pouch-facing side) of an illustrative embodiment of a
device-port interface;
[0023] FIG. 6 is a schematic, plan view of a second, pouch-facing
side of the illustrative embodiment of the device-port interface of
FIG. 5;
[0024] FIG. 7 is a schematic cross section of an illustrative
embodiment of the inline storage pouch shown in FIG. 2 taken along
line A-A;
[0025] FIG. 8 is a schematic cross section of an illustrative
embodiment of the inline storage pouch shown in FIG. 2 taken
parallel to line A-A and through an optional fluid-communication
button;
[0026] FIG. 9 is a schematic cross section of another illustrative
embodiment of the inline storage pouch shown in FIG. 2 taken along
line A-A;
[0027] FIG. 10 is a schematic cross section of another illustrative
embodiment of the inline storage pouch shown in FIG. 2 taken along
line A-A;
[0028] FIG. 11 is a schematic cross section of another illustrative
embodiment of the inline storage pouch shown in FIG. 2 taken along
line A-A;
[0029] FIG. 12 is a schematic cross section of another illustrative
embodiment of the inline storage pouch shown in FIG. 2 taken along
line A-A;
[0030] FIG. 13 is a schematic cross section of another illustrative
embodiment of the inline storage pouch shown in FIG. 2 taken along
line A-A;
[0031] FIG. 14 is a schematic cross section of another illustrative
embodiment of the inline storage pouch shown in FIG. 2 taken along
line A-A and shown on an animal;
[0032] FIG. 15 is a schematic plan view of an illustrative
embodiment of an inline storage pouch;
[0033] FIG. 16 is a schematic, perspective view of, inter alia, a
reduced-pressure indicator;
[0034] FIG. 17A is a schematic elevation view of the
reduced-pressure indicator of FIG. 12 shown in an extended
position;
[0035] FIG. 17B is a schematic elevation view of a portion of the
reduced-pressure indicator of FIG. 12 shown in a retracted
position;
[0036] FIG. 18 is a schematic plan view of an illustrative
embodiment of an inline storage pouch;
[0037] FIG. 19 is a schematic plan view of an illustrative
embodiment of an inline storage pouch;
[0038] FIG. 20 is a schematic plan view of an illustrative
embodiment of an inline storage pouch;
[0039] FIG. 21 is a schematic, illustrative flow diagram of steps
that may be performed using a microprocessor in an illustrative
system for treating a tissue site on an animal with reduced
pressure that involves storing liquids in an inline storage
pouch;
[0040] FIG. 22 is a schematic, perspective view of an illustrative
inline storage pouch for use with a system such as that shown in
FIG. 1;
[0041] FIG. 23 is a schematic cross-sectional view of the inline
storage pouch of FIG. 22;
[0042] FIG. 24 is a schematic, exploded perspective view of the
inline storage pouch of FIGS. 22-23;
[0043] FIG. 25 is a schematic elevation view of an illustrative
embodiment of a pouch connector shown in FIGS. 21-24;
[0044] FIG. 26 is a schematic cross-sectional view of the pouch
connector of FIG. 25; and
[0045] FIG. 27 is a schematic, perspective view showing primarily a
second, tissue-facing side of the pouch connector of FIGS.
25-26.
DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS
[0046] 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 not to be
taken in a limiting sense, and the scope of the illustrative
embodiments is defined only by the appended claims.
[0047] Referring now to the drawings and initially to FIGS. 1-7, an
illustrative embodiment of a system 100 for treating a tissue site
102 on an animal 104, which is deemed to include a human as shown,
with reduced pressure is presented. The system 100 includes an
inline storage pouch 106. The system 100 is shown on a human, but
the system 100 may be used on any animal 104, e.g., horse, cow,
dog, pig, turtle, etc. The system 100 includes a wound dressing 108
(or other fluid reception device), the inline storage pouch 106,
and a therapy unit 110, which includes a reduced-pressure source
112. Liquids are delivered to the inline storage pouch 106 for
storing. The liquids are removed from the animal 104 using reduced
pressure. The liquids are from a tissue site 102, e.g., a wound
site, but could also be from an ostomy bag or another source.
[0048] The system 100 may allow the user to position the weight of
the inline storage pouch 106 and the therapy unit 110 at different
locations on the animal. In other words, the weight of the
components of the system 100 may be distributed at different
locations as suggested in FIG. 1. Thus, the inline storage pouch
106 may be strapped to a portion of the animal 104, such as a leg,
using straps 107 (or other attachment devices). At the same time,
the therapy unit 110 may be attached at another location on the
animal 104, e.g., a torso, using straps 111.
[0049] The inline storage pouch 106 is flexible. The flexibility
allows the inline storage pouch 106 to conform to a portion of the
animal's body thereby enhancing safety and comfort. In addition,
the flexible nature of the inline storage pouch 106 allows the
inline storage pouch 106 to be stored in a small space. The inline
storage pouch 106 is relatively easy to manufacture compared to
rigid canisters that have been used to collect liquids. Moreover,
when the inline storage pouch 106 is used with non-human animals,
the flexible nature may help prevent injury when the animal bumps
surfaces or rolls over.
[0050] As shown best in FIG. 2, a wound 103 at tissue site 102 is
through epidermis 114 and into dermis 116. The wound dressing 108
is disposed on the tissue site 102, e.g., the wound 103, and is
operable to receive fluids from the tissue site 102. The wound
dressing 108 may be any type of dressing for receiving fluids from
the patient, but is shown as a dressing with a wound-interface
manifold 118 and a drape 120. The wound dressing 108 may be any
device that collects liquids whether a wound is involved or not.
For example, in one illustrative embodiment, the wound dressing 108
may be a device for removing liquids from an ostomy bag. Typically,
however, the wound dressing 108 is for removing liquids from a
wound 103. Fluids, including liquids, from the tissue site 102 are
delivered through a reduced-pressure interface 122 to a first
multi-lumen conduit 124. The first multi-lumen conduit 124 is
fluidly coupled to the inline storage pouch 106.
[0051] The reduced-pressure interface 122 includes a
reduced-pressure-supply conduit 126 and a pressure-assessment
conduit 128. The reduced-pressure-supply conduit 126 is fluidly
coupled to a reduced-pressure lumen 130 in the first multi-lumen
conduit 124. The pressure-assessment conduit 128 is fluidly coupled
to a sensing lumen 132 in the first multi-lumen conduit 124. In one
illustrative embodiment, the reduced-pressure interface 122 is 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 122 may be any
device capable of accomplishing at least two functions: (1) fluidly
coupling the reduced-pressure lumen 130 to the wound dressing 108
to deliver reduced pressure to the desired area and (2) fluidly
coupling the sensing lumen 132 to a sealed space created by the
drape 120.
[0052] The first multi-lumen conduit 124 is coupled to the inline
storage pouch 106 at a first port 133. The first port 133 is formed
on (including coupled to) the flexible pouch body 138. The flexible
pouch body 138 has a first side 139 and a second, animal-facing
side 141. The first port 133 may be formed on either side 139, 141,
but is shown on the second, animal-facing side 141.
[0053] The first port 133 may be any device that accomplishes at
least a couple functions. First, the first port 133 fluidly couples
the reduced-pressure lumen 130 of the first multi-lumen conduit 124
to an interior portion 136 (see FIG. 7) of a flexible pouch body
138. Second, the first port 133 fluidly couples the sensing lumen
132 of the first multi-lumen conduit 124 to a first bypass conduit
140. The first bypass conduit 140 is formed in the interior portion
136 of the flexible pouch body 138 and yet is fluidly isolated from
the interior portion 136. For example, without, limitation, the
first port 133 may be a patient-port interface 134.
[0054] Referring now primarily to FIGS. 3-4, an illustrative
embodiment of the patient-port interface 134 is presented. The
patient-port interface 134 includes a patient-port body 142 having
a first side 144 and a second, pouch-facing side 146. The
patient-port body 142 also includes a first hollow attachment
connector 148 sized and configured for mating with the at least one
reduced pressure lumen 130 of the first multi-lumen conduit 124.
The first hollow attachment connector 148 is fluidly coupled to a
first fluid outlet 150 formed on the patient-port body 142. The
patient-port interface 134 may be coupled to either the first 139
or second, animal-facing side 141 of the flexible pouch body
138.
[0055] The patient-port body 142 also includes a second hollow
attachment connector 152 sized and configured for mating with the
at least one sensing lumen 132 of the first multi-lumen conduit
124. The second hollow attachment connector 152 is fluidly coupled
to a first pressure-sensing connector 154 on the second,
pouch-facing side 146. The first pressure-sensing connector 154 is
fluidly coupled to a first end of the first bypass conduit 140. The
first pressure-sensing connector 154 may be substantially parallel
to the surface of the second, pouch-facing side 146 and may include
a conduit-channel 156. A first plurality of offsets 158 is formed
on the second, pouch-facing side 146 of the patient-port body 142
for providing flow space 160. The flow space 160 assures space for
reduced pressure to move fluids. In other words, the flow space 160
provides space for the fluids to expand and manifold into a fluid
storage material 204 or other portion of the interior portion
136.
[0056] Referring now primarily to FIGS. 1-4, fluids are moved via
pressure differential from the first fluid outlet 150 across the
interior portion 136 of the inline storage pouch 106 to a second
port 162 as suggested by arrows 163. The fluid is distributed
throughout the interior portion 136 as the reduced pressure draws
from the second port 162. The second port 162 fluidly couples the
interior portion 136 to a second reduced-pressure lumen 164 of a
second multi-lumen conduit 166. The second port 162 is shown
coupled to the first side 139 of the flexible pouch body 138. The
second port 162 may also be formed on the second, animal-facing
side 141. Typically, the first port 133 and second port 162 are on
opposite sides 139, 141 of the flexible pouch body 138.
[0057] The second reduced-pressure lumen 164 is fluidly coupled to
the reduced-pressure source 112 of the therapy unit 110. The first
bypass conduit 140 delivers fluid from the first port 133 to the
second port 162. The first bypass conduit 140 is fluidly isolated
from fluids in the interior portion 136 of the flexible pouch body
138. The second port 162 fluidly couples the first bypass conduit
140 to a second sensing lumen 168 of the second multi-lumen conduit
166. The second sensing lumen 168 may be fluidly coupled to a
pressure sensing unit 170 of the therapy unit 110. The second port
162 may be any device that accomplishes at least two functions.
First, the second port 162 fluidly couples the first bypass conduit
140 to the second sensing lumen 168. Second, the second port 162
fluid couples the second reduced-pressure lumen 164 to the interior
portion 136 of the flexible pouch body 138. In one illustrative
embodiment, the second port 162 is a device-port interface 172.
[0058] Referring now primarily to FIGS. 5-6, an illustrative
embodiment of a device-port interface 172 is presented. The
device-port interface 172 includes a device-port body 174 having a
first side 176 and a second, pouch-facing side 178. The device-port
body 174 includes a third hollow attachment connector 180 sized and
configured for mating with the second reduced-pressure lumen 164.
The third hollow attachment connector 180 is fluidly coupled to a
fluid inlet 182. The third hollow attachment connector 180 is
formed on (including coupled to) the device-port body 174.
[0059] The device-port body 174 also includes a fourth hollow
attachment connector 184 sized and configured for mating with the
second sensing lumen 168 of the second multi-lumen conduit 166. A
second pressure-sensing connector 186 is fluidly coupled to the
fourth hollow attachment connector 184. The second pressure-sensing
connector 186 is fluidly coupled to a second end of the first
bypass conduit 140. The second pressure-sensing connector 186 may
be substantially parallel to the surface of the second,
pouch-facing side 178 and may include a conduit-channel 187.
[0060] The device-port interface 172 may further include an offset
188 formed on the second, pouch-facing side 178 of the device-port
body 174 for providing a filter space 192 for one or more
hydrophobic filters with bacterial filtering properties. In this
embodiment, the offset 188 is a wall 190 that forms the filter
space 192. A filter 194 or multiple filters are disposed within the
filter space 192. The filter 194 may be any material that prevents
liquids from entering the fluid inlet 182. In one embodiment, the
filter 194 includes a hydrophobic filter member, a manifolding
material, and another hydrophobic filter member or any permutation
thereof or functional device to prevent liquids from entering the
fluid inlet 182. The filter 194 or filters are hydrophobic,
bacterial filtering membranes that are located to prevent fluids
and bacteria from progressing towards the therapy unit 110. As an
illustrative, non-limiting embodiment, the filter membrane may be a
GORE.RTM. MMT314 material available from W. L. Gore &
Associates, Inc., Newark, Del. The one or more filters 194 are
displaced from the base of the device-port interface 172 by
castilated surface features (not explicitly shown) or other surface
features designed to provide an open area of filter for flow. A
charcoal filter may also be included to remove odor. In another
illustrative embodiment, a porous polymer, gel-blocking filter may
be included in the second reduced-pressure lumen 164.
[0061] Referring now primarily to FIGS. 1-2 and 7, the flexible
pouch body 138 of the inline storage pouch 106 is formed with a
first wall 196 and a second wall 198. The two walls 196, 198 are
coupled or formed as a single unit to form the flexible pouch body
138. The flexible pouch body 138 has the interior portion 136
formed between the walls 196, 198. For example, in one illustrative
embodiment, the first wall 196 and the second wall 198 are coupled
by an attachment 200 at a peripheral edge 202 of the walls 196,
198. The attachment 200 may be formed using any known technique,
including without limitation welding (e.g., ultrasonic or RF
welding), bonding, adhesives, cements, stitching, staples, or
another coupling device.
[0062] The first wall 196 and second wall 198 may be formed from
any flexible, liquid-impermeable material. For example, the first
wall 196 and second wall 198 may be formed from one or more of the
following: 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, silicones, silicone drape, a 3M
Tegaderm.RTM. drape, or a polyurethane (PU) drape such as one
available from Avery Dennison Corporation of Pasadena, Calif., or
other appropriate material. The inline storage pouch 106 may be
sized to accommodate the quantity of liquid anticipated for a
typical treatment time. In one illustrative, non-limiting
embodiment, the interior portion 136 has a volume greater than 180
milliliters and less than 500 milliliters, but numerous sizes may
be used.
[0063] The interior portion 136 formed by the flexible pouch body
138 may be filled at least in part by the fluid storage material
204. The storage material 204 may be formed from any material that
receives fluids, including liquids; retains the fluids; and allows
reduced pressure to be transmitted. In the illustrative embodiment
of FIG. 7, the fluid storage material 204 comprises an absorbent
member 206, a first wicking member 208, and a second wicking
material 210. The absorbent member 206 may be any material that
retains liquids and may comprise one or more of the following:
Luquafleece.RTM. material, BASF 402c, Technical Absorbents 2317
available from Technical Absorbents (www.techabsorbents.com),
sodium polyacrylate super absorbers, cellulosics (carboxy methyl
cellulose and salts such as sodium CMC), or alginates. The first
wicking member 208 and second wicking member 210 may be formed from
one or more of the following: non-woven fabrics such as Libeltex
TDL2 or other non-wovens from LIBELTEX bvba of Belgium
(www.libeltex.com), woven fabrics including 3D spacer fabrics and
Textiles (Baltex, Ilkeston, Derby, UK), open-cell foam, or sintered
polymers. The wicking members 208, 210 may be formed by multiple
layers of wicking materials that have been stacked or layered.
[0064] The first wicking member 208 and the second wicking member
210 may be disposed adjacent to one another at least at their
peripheral edges 216 and coupled with an attachment 214 (analogous
to attachment 200 as previously described). Thus, the wicking
members 208, 210 surround the absorbent member 206. The peripheral
edges 216 form overlapping portions and are held in contact with
one another to provide a fluid coupling between the wicking members
208, 210. The wicking members 208, 210 may thus be in fluid
communication with each other. The wicking members 208, 210 allow
fluid flow between the wicking members 208, 210 and along the
wicking members 208, 210 at times when the flow of fluid in the
absorbent member 206 is inhibited or blocked. In this embodiment,
the first bypass conduit 140 comprises a tube 218, but it could
also be a web member 212 attached against a portion of wall 196
(FIG. 11), or any device that provides a path to move fluid through
the interior portion 136 while remaining fluidly isolated from the
interior portion 136.
[0065] Referring now primarily to FIGS. 2 and 8, another
illustrative inline storage pouch 106 is presented. The inline
storage pouch 106 is analogous in most respects to the inline
storage pouch 106 of FIGS. 1, 2, and 7, and accordingly, some parts
are labeled but not further described here. In this embodiment, the
primary difference is that the flexible pouch body 138 is formed
with one or more optional fluid-communication buttons 207.
[0066] Each fluid communication-button 207 may be formed by
creating an aperture 209 in the absorbent member 206. The first
wicking member 208 and second wicking member 210 are brought into
contact in the aperture 209, and first wicking member 208 and
second wicking member 210 are attached at or near the point of
contact. The wicking members 208, 210 are attached using one or
more attachments 211 (analogous to 214). This embodiment may be
particularly useful in minimizing pressure drop across the inline
storage pouch 106 when the wicking members 208, 210 are formed from
a non-woven manifolding material. The fluid-communication
communication buttons 207 enhance the degree of fluid communication
between the first wicking member 208 and second wicking member
210.
[0067] Referring now primarily to FIGS. 2 and 9, another
illustrative inline storage pouch 106 is presented. The inline
storage pouch 106 is analogous in most respects to the inline
storage pouch 106 of FIGS. 1, 2, and 7-8, and accordingly, some
parts are labeled but not further described here. The primary
difference in this embodiment is that a first plurality of offsets
215 has been formed and disposed between the first wall 196 and the
fluid storage material 204. In this embodiment, the first plurality
of offsets 215 may be positioned between the first wall 196 and the
first wicking member 208. The first plurality of offsets 215 may
include a first base 217.
[0068] The inline storage pouch 106 may also include a second
plurality of offsets 219. The second plurality of offsets 219 may
be disposed between the second wall 198 and the fluid storage
material 204. In this embodiment, the second plurality of offsets
219 may be positioned between the second wicking member 210 and the
second wall 198. The second plurality of offsets 219 may include a
second base 221. The offsets 215, 219 create additional space for
the flow of reduced pressure within the interior portion 136. The
inline storage pouch 106 of FIG. 9 may be used with a
high-vapor-transfer-rate material as described in connection with
FIG. 14 below, but typically the first base 217 and second base 221
would be perforated.
[0069] The offsets 215, 219 may formed from any rigid or semi-rigid
material approved for use in a body. The offsets 215, 219 are
typically formed from a non-absorbent material. The offsets 215,
219 may be formed, for example, from a high-impact polystyrene and
may be vacuumed formed to a desired shape (e.g., cylinder, tube,
cone, or other shape) and sized as desired for the chamber or
interior space. The offsets 215, 219 with their respective bases
217, 221 are flexible and reduced pressure can pass in between the
offsets, i.e., through the bases 217, 221, which may permeable or
perforated. The offsets 215, 219 facilitate open flow for reduced
pressure transmission under compression. The offsets 215, 219 may
vary in quantity and pattern or shape and size but should allow
pressure to be transmitted and the inline storage pouch 106 to
remain flexible. In one illustrative embodiment, the offsets 215,
219 may be any shape or size that provides clearance of at least 1
mm.
[0070] Referring now primarily to FIG. 10, another illustrative
inline storage pouch 106 is presented. The inline storage pouch 106
is analogous in most respects to the inline storage pouch 106 of
FIGS. 1, 2, and 7-9, and accordingly, some parts are labeled but
not further described here. The primary difference in this
embodiment is that the inline storage pouch 106 includes a first
plurality of offsets 215 and a third wicking member 223. As in FIG.
9, the first plurality of offsets 215 are disposed between the
first wall 196 and the fluid storage material 204 to create
additional flow space for reduced pressure to flow. The third
wicking member 223 may be disposed between the second wall 198 and
the fluid storage material 204. The third wicking member 223 may be
formed from the same materials as the first wicking member 208.
[0071] In this embodiment, the third wicking member 223 may be
disposed between the second wall 198 and the second wicking member
210. The third wicking member 223 provides additional manifolding
material for fluid flow. In other embodiments, additional wicking
members may be added in addition to the third wicking member 223.
Moreover, in other embodiments, one or more additional wicking
members may be added between the first wall 196 and the absorbent
member 206.
[0072] Referring now primarily to FIG. 11, another illustrative
inline storage pouch 106 is shown in cross section. The inline
storage pouch 106 is analogous in most respects to the inline
storage pouch 106 of FIGS. 1, 2, and 7-10, and accordingly, some
parts are labeled but not further described here. In this
illustrative embodiment, a first bypass conduit 140 may be formed
by the web member 212 attached against the portion of wall 196. The
web member 212 may be formed from the same material as the first
wall 196. The first bypass conduit 140 includes a conduit-manifold
material 213. The conduit-manifold material 213 may be any material
that is sufficient to prevent the first bypass conduit 140 from
collapsing under reduced pressure.
[0073] Referring now primarily to FIG. 12, another illustrative
inline storage pouch 106 is shown in cross section. The inline
storage pouch 106 is analogous in most respects to the inline
storage pouch 106 of FIGS. 1, 2, and 7-11, and accordingly, some
parts are labeled but not further described here. In this
illustrative embodiment, a first bypass conduit 140 is formed by
using a third wall 199 that together with the first wall 196 forms
the first bypass conduit 140. The third wall 199 may be formed from
the same materials as the first wall 196. Like in FIG. 11, the
first bypass conduit 140 may be at least partially filled with a
conduit-manifold material 213. This embodiment allows the first
bypass conduit 140 to extend the width of the flexible pouch body
138.
[0074] Referring now primarily to FIG. 13, another illustrative
inline storage pouch 106 is shown in cross section. The inline
storage pouch 106 is analogous in most respects to the inline
storage pouch 106 of FIGS. 1, 2, and 7-12, and accordingly, some
parts are labeled but not further described here. In FIG. 13, the
fluid storage material 204 comprises an absorbent member 206
surrounded by a wicking member 208 that has been coated, extruded,
or otherwise directly applied onto the exterior of the absorbent
member 206.
[0075] Referring now primarily to FIG. 14, another illustrative
inline storage pouch 106 is shown in cross section. The inline
storage pouch 106 is analogous in most respects to the inline
storage pouch 106 of FIGS. 1, 2, 7-13, and accordingly, some parts
are labeled but not further described here. In FIG. 14, the first
wall 196 or second wall 198 are formed from a
high-vapor-transfer-rate material. The
high-moisture-vapor-transfer-rate ("MVTR") material may be formed
from any material that allows vapor to egress but not liquids.
"Moisture Vapor Transmission Rate" or "MVTR" represents the amount
of moisture that can pass through a material in a given period of
time. The high-moisture-vapor-transfer-rate material typically has
a moisture vapor transmission rate greater than 300 g/m.sup.2/24
hours and more typically 1000 g/m.sup.2/24 hours or more. The
high-moisture-vapor-transfer-rate material allows vapor to egress
or diffuse from the interior portion 136, but not liquids.
[0076] The high-moisture-vapor-transfer-rate material may comprise
one or more of the following: hydrophilic polyurethane,
cellulosics, hydrophilic polyamides, an INSPIRE.TM. 2301 material
from Exopack Advanced Coatings of Wrexham, United Kingdom; a thin,
uncoated polymer drape; or polyvinyl alcohol, polyvinyl
pyrrolidone, hydrophilic acrylics, hydrophilic silicone elastomers
and copolymers of these. The INSPIRE.TM. 2301 illustrative film has
an MVTR (inverted cup technique) of 14500-14600 g/m.sup.2/24 hours.
See www.exopackadvancedcoatings.com. The
high-moisture-vapor-transfer-rate materials may have various
thicknesses, such as 10 to 40 microns (.mu.m), e.g., 15, 20, 25,
30, 35, 40 microns (inclusive of all numbers in the stated
range).
[0077] The inline storage pouch 106 has a flexible pouch body 138
with an interior portion 136. Like in FIG. 11, the interior portion
136 is at least partially filled with a storage material 204 that
may be formed with a first wicking member 208, an absorbent member
206, and a second wicking member 210. The wicking members 208, 210
may be coupled at their peripheral edges 216 by an attachment 214
(analogous to attachment 200).
[0078] The inline storage pouch 106 of FIG. 14 is shown on the
animal's epidermis 114. Some clearance between the epidermis 114
and inline storage pouch 106 may be provided by hair 220. Moisture
from the animal's epidermis 114 may ingress into the interior
portion 136 through the second wall 198, which is formed from a
high-moisture-vapor-transfer-rate material. The ingress is due to a
moisture imbalance. The moisture enters the second wicking member
210. In addition, moisture may egress the interior portion 136
through the first wall 196, which may also comprise a
high-moisture-vapor-transfer-rate material. The egress is due to a
moisture imbalance between the interior portion 136 and the
external atmosphere across the high-moisture-vapor-transfer-rate
material. In another embodiment, a third wicking member may be
added on an exterior of the second wall 198 to wick moisture away
from the animal's epidermis 114.
[0079] In operation according to one illustrative embodiment, the
wound dressing 108 is applied to the tissue site 102. The inline
storage pouch 106 is positioned at a desired location on the animal
104 or near the animal 104 depending on the application. If applied
on the animal 104, the inline storage pouch 106 may be strapped,
tapped, or otherwise secured to the animal 104. The inline storage
pouch 106 is fluidly coupled to the wound dressing 108 to provide
reduced pressure to the wound dressing 108 and to receive
wound-site pressure from the tissue site 102. The therapy unit 110
may also be positioned on or near the animal 104. The therapy unit
110 is fluidly coupled to the inline storage pouch 106. The therapy
unit 110 provides reduced pressure to the inline storage pouch 106
and receives the wound-site pressure for determining pressure at
the tissue site 102. The therapy unit 110 may control the therapy,
analyze any blockages, and provide alerts as described further
below.
[0080] As operation continues, fluids are pulled from the animal
104 into the inline storage pouch 106. The fluid enters the first
port 133 and is pulled toward the second port 162. As the fluid is
pulled, the fluid is distributed throughout the interior portion
136 and particularly in the fluid storage material 204. As liquids
build in the inline storage pouch 106, gases--typically
air--continue to move or to manifold through the interior portion
136. The gases may move through the interior portion 136 primarily
through the wicking members 208, 210 when included or through space
created by the third wicking member 223 or by the offsets 215, 219.
Once the inline storage pouch 106 at least partially fills, liquid
reaches the second port 162 and the flow is discontinued. In
another illustrative embodiment, baffles or internal walls may be
added in the interior portion 136 to cause the fluid flow to take a
tortuous path between the ports 133, 162.
[0081] Referring now primarily to FIGS. 15-17B, another
illustrative inline storage pouch 106 is presented. The inline
storage pouch 106 is analogous in most respects to the inline
storage pouch 106 of FIGS. 1, 2, and 7-14, and accordingly, some
parts are labeled but not further described here. In addition,
components referenced but not explicitly shown are analogous to
those previously presented. In this illustrative embodiment, the
flexible pouch body 138 includes a first port 133 having a first
reduced-pressure indicator 222 and a second port 162 having a
second reduced-pressure indicator 224. The ports 133, 162 are shown
on the same side of the flexible pouch body 138, but it should be
understood that one or both of the ports 133, 162 may be located on
the opposite side as shown in other figures herein.
[0082] The first reduced-pressure indicator 222 may be fluidly
coupled to the interior portion 136 of the flexible pouch body 138
proximate to the first port 133 or as an aspect of the first port
133. The first reduced-pressure indicator 222 may be included as an
aspect of the patient-port interface 134 as shown in FIG. 16. The
first reduced-pressure indicator 222 provides a visual indication
of whether or not the first reduced-pressure indicator 222
experiences a reduced pressure greater than a first threshold.
[0083] Similarly, the second reduced-pressure indicator 224 may be
fluidly coupled to the interior portion 136 of the flexible pouch
body 138 proximate to the second port 162 and may be part of the
device-port interface 172. The second reduced-pressure indicator
224 provides a visual indication of whether or not the second port
162 experiences a reduced pressure greater than a second threshold,
which may be the same as the first threshold.
[0084] Referring now primarily to FIGS. 16-17, the reduced-pressure
indicators 222, 224 are described. The reduced-pressure indicators
222, 224 are analogous to one another. The reduced-pressure
indicators 222, 224 may each be formed with a moving member 226
adapted to move when reduced pressure exceeds a threshold pressure
(P.sub.t). The reduced-pressure indicators 222, 224 have a visual
indicator 228 associated with the moving member 226. In one
embodiment, the visual indicator 228 is an indicator member 230 or
portion, such as a disk-shaped member 232 (or button), or a member
of any shape that signifies a changed state with respect to
pressure.
[0085] The moving member 226 may be a collapsible wall 234 that has
a first end 236 and a second end 238. The first end 236 may be
coupled to the indicator member 230. The second end 238 may be
coupled to a base 240. The collapsible wall 234 and indicator
member 230 form a pressure vessel with base 240. The collapsible
wall 234 may have a convex interior surface and may include baffles
or other features to assist in collapsing at the threshold
pressure.
[0086] When reduced pressure delivered to the interior portion 136
exceeds the threshold pressure (P.sub.t), the collapsible wall 234
collapses (alone or with movement in the base 240) and causes the
visual indicator 228 to go from a first position, e.g., an extended
position, to a second position, e.g., a retracted position, as
shown in FIGS. 17A and 17B, respectively. The collapsible walls 234
of the reduced-pressure indicator may be sized and shaped to
collapse or move the indicator member 230 to be substantially flush
or against the base 240 when the threshold reduced pressure
(P.sub.t) is achieved. When the pressure rises (with reference to
absolute pressure) above the threshold reduced pressure (P.sub.t),
the collapsible wall 234 returns to the extended position. In other
words, the reduced pressure causes the reduced-pressure indicator
to collapse as long as there is adequate reduced pressure.
[0087] The thickness of the collapsible wall 234, wall material
stiffness, and wall geometry are variables that impact the pressure
at which the collapsible wall 234 collapses. The rigidity of the
base 240 may also be a factor. While the wall thickness of the
collapsible wall 234 may be determined using finite element
analysis, it may be necessary to empirically determine the wall
thickness to achieve movement at the threshold pressure (P.sub.t).
In some embodiments, the collapsible wall 234 may be designed so
that the collapsible wall 234 collapses by sudden buckling as the
threshold pressure (P.sub.t) is crossed, providing a binary
indication. The reduced-pressure indicator 222, 224 may be formed
on the base 240 with other aspects of the patient-port interface
134 or device-port interface 172.
[0088] The reduced-pressure indicator 222, 224, interfaces 134,
172, and base 240 may be formed from a medical-grade, soft polymer
or other pliable material, such as one or more of the following:
polyurethane, polyethylene, polyvinyl chloride (PVC),
fluorosilicone, ethylene-propylene, DEHP-free PVC, or other
material. The components may be cast, or extruded, and may be
formed as an integral unit.
[0089] In operation, if the pressure sensing unit 170 shows a lack
of reduced pressure at the tissue site 102, the user may analyze
the situation using the reduced-pressure indicators 222, 224. If
pressure is being received at the first reduced-pressure indicator
222, i.e., the indicator member 230 shows that the collapsible wall
234 is still collapsed, then a problem exists between the tissue
site 102 and the inline storage pouch 106. If the first
reduced-pressure indicator 222 shows inadequate pressure, i.e., the
indicator member 230 shows that the collapsible wall 234 is no
longer collapsed and if the second reduced-pressure indicator 224
shows adequate pressure, i.e., the indicator member 230 shows that
the collapsible wall 234 is still collapsed, then a problem exists
within the inline storage pouch 106. If the second reduced-pressure
indicator 224 shows inadequate pressure, i.e., the indicator member
230 shows that the collapsible wall 234 is no longer collapsed,
then a problem exists with either the filter 194 being occluded or
somewhere between the inline storage pouch 106 and the
reduced-pressure source 112.
[0090] Referring now primarily to FIG. 18, another illustrative
embodiment of an inline storage pouch 106 is presented. The inline
storage pouch 106 is analogous in most respects to the inline
storage pouch 106 of FIGS. 1, 2, and 7-14, and accordingly, some
parts are labeled but not further described here. In addition,
components referenced but not explicitly shown are analogous to
those previously presented. The illustrative embodiment of FIG. 18
includes a second bypass conduit 242 fluidly disposed within and
fluidly isolated from the interior portion 136 of the flexible
pouch body 138. The second bypass conduit 242 has a first end 244
and a second end 246. The first end 244 of the second bypass
conduit 242 may be fluidly coupled to the interior portion 136 of
the flexible pouch body 138 proximate to the first port 133 at a
first pressure-sensing pad 248. In addition to the second
reduced-pressure lumen 164 and second sensing lumen 168, the second
multi-lumen conduit 166 also includes a first
pouch-pressure-sensing conduit 250. The second end 246 of the
second bypass conduit 242 may be fluidly coupled to the first
pouch-pressure-sensing conduit 250. The first port 133 may be
located on the second, animal-facing side of the flexible pouch
body 138 and the second port 162 may be on the first side 139. In
another illustrative embodiment, the ports 133, 162 may be on the
same side or reverse sides as to what is described herein above
[0091] Still with reference to FIG. 18 and to a lesser extent to
FIG. 2, the pressure sensing unit 170 may be fluidly coupled to the
second sensing lumen 168 and separately to the first
pouch-pressure-sensing conduit 250. Thus, therapy unit 110, which
also may include a microprocessor 253, is able to determine the
pressure at the tissue site 102 and also in the interior portion
136 of the flexible pouch body 138 proximate to the first port 133.
The therapy unit 110 may check the pressure proximate the first
port 133 (in the first pressure-sensing pad 248) proactively or if
inadequate pressure, i.e., below a threshold, is determined at the
tissue site 102. If adequate pressure exists in the first
pressure-sensing pad 248 but not at the tissue site 102, the
therapy unit 110 may provide an alert that a blockage exists
between the inline storage pouch 106 and the tissue site 102. If
inadequate pressure exists at the first pressure-sensing pad 248,
the therapy unit 110 may signal that the inline storage pouch 106
is full or block exists between the inline storage pouch 106 and
the reduced-pressure source 112.
[0092] Referring now primarily to FIG. 19 and to a lesser extent
FIG. 2, another illustrative embodiment of an inline storage pouch
106 is presented. The inline storage pouch 106 is analogous in most
respects to the inline storage pouch 106 of FIGS. 1, 2, 7-14, and
18, and accordingly, some parts are labeled but not further
described here. In addition, components referenced but not
explicitly shown are analogous to those previously presented.
[0093] In this embodiment, a second pressure-sensing pad 252 has
been coupled proximate to the second port 162. The second
pressure-sensing pad 252 includes a filter element (not explicitly
shown) that becomes occluded when saturated with liquid. The second
pressure-sensing pad 252 may be fluidly coupled to the interior
portion 136 of the flexible pouch body 138 proximate to the second
port 162. As before, the second multi-lumen conduit 166 further
includes a first pouch-pressure-sensing conduit 250 fluidly coupled
to the pressure sensing unit 170 of the therapy unit 110. When the
therapy unit 110 detects that the second pressure-sensing pad 252
is occluded, the therapy unit 110 may signal that the inline
storage pouch 106 is full.
[0094] Referring now primarily to FIG. 20 and to a lesser extent
FIG. 2, another illustrative embodiment of an inline storage pouch
106 is presented. The inline storage pouch 106 is analogous in most
respects to the inline storage pouch 106 of FIGS. 1, 2, 7-14, and
18-19 and accordingly, some parts are labeled but not further
described here. In addition, components referenced but not
explicitly shown are analogous to those previously presented.
[0095] In this embodiment, the inline storage pouch 106 includes
the second bypass conduit 242 as in FIG. 18 fluidly coupled to the
interior portion 136 of the flexible pouch body 138 proximate to
the first port 133. The second bypass conduit 242 may also be
fluidly coupled to the first pouch-pressure-sensing conduit 250.
The inline storage pouch 106 also includes a second
pressure-sensing pad 252 like in FIG. 19 fluidly coupled to the
interior portion 136 of the flexible pouch body 138 proximate to
the second port 162 and to a second pouch-pressure-sensing conduit
254. The second pouch-pressure-sensing conduit 254 may be fluidly
coupled to the second pressure-sensing pad 252 and to a therapy
unit 110.
[0096] The portion of the system 100 shown in FIG. 20 includes the
therapy unit 110. The therapy unit 110 includes the
reduced-pressure source 112 and pressure sensing unit 170. The
pressure sensing unit 170 includes a first pressure sensing device
258, a second pressure sensing device 260, and a third pressure
sensing device 262. The first pressure sensing device 258 is
fluidly coupled to the pressure-assessment conduit 128 of the
reduced-pressure interface 122 for determining a wound-site
pressure, i.e., the pressure at the tissue site 102. The second
pressure sensing device 260 may be fluidly coupled to the first
pressure-sensing pad 248 for determining pressure proximate the
first port 133. The third pressure sensing device 262 may be
fluidly coupled to the second pressure-sensing pad 252 for
determining pressure at the second port 162.
[0097] More particularly, the first pressure sensing device 258 may
be fluidly coupled to the second sensing lumen 168 of the second
multi-lumen conduit 166. The second sensing lumen 168 may also be
fluidly coupled to the first bypass conduit 140 and to the sensing
lumen 132 of the first multi-lumen conduit 124. The sensing lumen
132 may be fluidly coupled to the pressure-assessment conduit 128.
The second pressure sensing device 260 may be fluidly coupled to
the first pouch-pressure-sensing conduit 250. The first
pouch-pressure-sensing conduit 250 may be fluidly coupled to the
second bypass conduit 242. The second bypass conduit 242 may be
fluidly coupled to first pressure-sensing pad 248 proximate to the
first port 133. The third pressure sensing device 262 may be
fluidly coupled to the second pouch-pressure-sensing conduit 254.
The second pouch-pressure-sensing conduit 254 may be fluidly
coupled to the second pressure-sensing pad 252.
[0098] With the portion of the system 100 shown in FIG. 20, the
therapy unit 110 may pinpoint the location (or at least give an
area) of blockage or may indicate that the inline storage pouch 106
is full. Referring now primarily to FIG. 21, one possible logic
flow for operation of the system in FIG. 20 is presented. The
process begins at step 264 and the first interrogatory box 266
inquires as to whether or not the desired pressure is being
realized at the tissue site 102. The microprocessor 253 may
determine this by comparing the pressure determined by the first
pressure sensing device 258 with a selected pressure threshold. If
the interrogatory is affirmative, the process continues back along
path 268. If not, the microprocessor 253 may activate the
reduced-pressure source 112 at step 270 to provide reduced
pressure. Optionally a certain amount of time may be required
before moving beyond step 270 and the interrogatory box 266 may be
revisited.
[0099] With inadequate pressure existing, the interrogatory box 272
is reached and calls for the pressure to be checked at the second
port 162 by the second pressure-sensing pad 252. The microprocessor
253 receives the pressure from the third pressure sensing device
262. If there is not a reduced pressure greater (i.e., more reduced
with respect to absolute pressure) than a threshold reduced
pressure at the second port 162, a flag is raised at step 274 that
a blockage exists between the reduced-pressure source 112 and the
inline storage pouch 106. If adequate pressure is at the second
port 162, the problem must be elsewhere and the process continues
to interrogatory box 276. Interrogatory box 276 inquires as to the
pressure at the first port 133. The microprocessor 253 receives the
pressure from the second pressure sensing device 260. If the
pressure is inadequate, step 278 is reached an alert posted that
the pouch is full or blocked.
[0100] If pressure exists at the first port 133 but not at the
tissue site 102, which is the question of interrogatory box 280, an
alert is issued at step 282 that a blockage exists between the
inline storage pouch 106 and the wound dressing 108. If pressure
exists at the tissue site 102, but is not adequate, another round
of analysis may occur as suggested by path 284. A counter or
chronograph may be included to limit the number of times through
the cycle. Thus, after a maximum count or maximum time, an error
flag may be provided. If adequate pressure is now realized at the
tissue site 102, the answer to interrogatory box 286 is positive
and the process continues from interrogatory box 286 to
interrogatory box 266. This is one illustrative process and many
others may be used. Those skilled in the art will understand
various ways to implement the functionality in hardware or
software. In addition, portions of this process may be used
separately.
[0101] Referring now primarily to FIGS. 22-27, another illustrative
embodiment of an inline storage pouch 300 is presented. The inline
storage pouch 300 is analogous in many respects to the inline
storage pouch 106 of the previous figures. The inline storage pouch
300 includes a pouch connector 302. The inline storage pouch 300
may be used as part of a system, e.g., system 100 of FIG. 1, to
treat a tissue site on an animal.
[0102] The inline storage pouch 300 includes a flexible pouch body
304. The flexible pouch body 304 is formed with a first wall 306, a
second wall 308, and a partitioning wall 310. The walls 306 and 308
form an interior portion partitioned by the partitioning wall 310
to form a first chamber 312 and a second chamber 314. The walls may
be formed from any liquid-impermeable, flexible material, for
example, polyurethane or any of those materials previously
mentioned for the wall 196. The flexible pouch body 304 has a
proximal end 316 and a distal end 318. A longitudinal axis extends
generally between the proximal end 316 and the distal end 318.
[0103] A first manifolding material 320 is disposed within the
first chamber 312. The first manifolding material 320 may be formed
from the same materials as conduit-manifold material 213, e.g.,
BASF Luquafleece 402C or an analogous material.
[0104] A fluid storage material 321 is disposed within the second
chamber 314. The fluid storage material 321 may be surrounded by a
wicking material 322. The wicking material 322 may be one or more
of the materials mentioned for wicking material 208, e.g., Libeltex
TDL2 80 gsm or an analogous material. The wicking material 322 may
be two separate pieces of material that are welded or otherwise
coupled at their peripheral edges 324 to form a "tea bag" like
arrangement containing the fluid storage material 321. The wicking
material 322 may include one or more apertures, e.g., aperture 323
to facilitate a portion of the pouch connector 302 to extend
therethrough.
[0105] A second manifolding material 326 may also be disposed
within the second chamber 314. The second manifolding material 326
may be the same as first manifolding material 320, but in another
embodiment is shown as a plastic layer 328 having offsets 330. The
offsets 330 may be in the range 0.25-0.5 mils from a base of the
plastic layer. The offsets 330 may be formed by injection molding
the plastic layer 328 with offsets or vacuum forming. The offsets
330 may be ridges a shown, pegs, or any spacer. The second
manifolding material 326 functions to ensure that the exudate
collecting area (chamber) remains open. The offsets 330 may be the
same or analogous to offsets 215, 219.
[0106] The pouch connector 302 is coupled to the flexible pouch
body 304 proximate the proximal end 316 but could be placed at
other locations. The pouch connector 302 receives fluids from the
animal and delivers the fluids to the second chamber 314. The pouch
connector 302 also fluidly couples reduced pressure received from a
reduced-pressure source to the first chamber 312.
[0107] The pouch connector 302 includes a connector body 332 formed
with an exudate chamber 334. The exudate chamber 334 has an intake
port 336 for receiving the fluids from the animal and an outlet 338
for discharging the fluids from the animal. The intake port 336 may
comprise a first tube connector 337 for coupling to a first conduit
339. The first tube connector 337 may include a tube lock 372. The
first conduit 339 may be a multi-lumen conduit having a first
reduced-pressure lumen 341 and a first pressure-sensing lumen 343.
A displacement conduit 340 is fluidly coupled to the outlet port
338 and the second chamber 314 for delivering the fluids from the
exudate chamber 334 to the second chamber 314. The displacement
conduit 340 may be a tube or a hollow offset that is open or the
like.
[0108] The connector body 332 is also formed with a
reduced-pressure chamber 342. The exudate chamber 334 and
reduced-pressure chamber 342 are fluidly isolated from each other
within the pouch connector 302 by a portion of the connector body
332. The reduced-pressure chamber 342 has an intake port 344 for
receiving fluids from the first chamber 312 and an outlet port 346
for discharging fluids. The outlet port 346 of the reduced-pressure
chamber 342 is for receiving the reduced pressure from the
reduced-pressure source. The outlet port 346 may comprise a tube
connector 348 that couples to a second conduit 350 that is fluidly
coupled to a reduced-pressure unit or source, e.g., therapy unit
110 in FIG. 2. The second conduit 350 may be a multi-lumen conduit
that has a reduced-pressure lumen for delivering reduced pressure
ultimately to the first chamber and a second pressure-sensing lumen
for receiving reduced pressure ultimately from the first
reduced-pressure sensing lumen via the pouch connector 302.
[0109] The connector body 332 may also includes a plurality of
offsets 352 on the connector body 332 proximate to the intake port
344 of the reduced-pressure chamber 342. The offsets 352 may be in
the range of 0.5 mils to several mils. The offsets 352 function to
ensure fluid flow proximate to the intake port 344 in the first
chamber 312.
[0110] The intake port 336 of the exudate chamber 334 may be
substantially parallel to the outlet port 346 of the
reduced-pressure chamber 342. The flexible pouch body 304 has a
longitudinal axis (substantially parallel to section line 23-23 in
FIG. 22) that may be substantially parallel to the axis of the
intake port 336 of the exudate chamber 334 and may be perpendicular
to the axis of the displacement conduit 340.
[0111] The partitioning wall 310 of the flexible pouch body 304 is
formed with an exudate aperture 354 for receiving a portion of the
pouch connector 302, e.g., the displacement conduit 340, into the
second chamber 314. The partitioning wall 310 may be coupled to the
displacement conduit 340 to form a fluid seal to prevent fluid from
entering the first chamber 312 from the second chamber at that
point. The coupling may be formed using any coupling technique,
e.g., glue, epoxy, UV glue, welds, bonds, or other techniques.
[0112] A first connector aperture 355 may be formed in the first
manifold material 320 on the proximal end 316. The exudate aperture
354 is formed on the proximal end of the partitioning wall 310 and
is sized and configured to align with exudate aperture 354. At the
other end, the distal end of the partitioning wall 310, a return
aperture 356 is formed for allowing fluid flow from the second
chamber 314 into the first chamber 312. Stated another way, reduced
pressure may flow from the first chamber 312 through the return
aperture 356 to the second chamber 314. A primary filter 358, e.g.,
a hydrophobic filter, covers the return aperture 356 to inhibit
liquids from entering the first chamber 312. A secondary filter 360
may also be included that covers the fluid path of the return
aperture 356. A piece of manifolding material 362 may be used to
separate the primary filter 358 and the secondary filter 360. An
apron of polyurethane 364 or other material may be used to secure
secondary filter 360 and the manifolding material 362 to a first
side of the partitioning wall 310. A charcoal filter or other odor
filter may be added as well.
[0113] A second connector aperture 366 may be formed in the first
wall 306 to allow a portion of the pouch connector 302 to extend
through the second connector aperture 366. The second connector
aperture 366 may facilitate coupling a portion of the first wall
306 to a base portion 368 of the pouch connector 302.
[0114] As shown best in FIG. 24, the fluid storage material 321 may
have one or more apertures 370. The apertures 370 facilitate
coupling of a portion of the partitioning wall 310 to the second
wall 314 at locations between the proximal and distal ends. While
not explicitly shown, apertures in the wicking material 322 may be
formed that align with the apertures 370.
[0115] Referring primarily to FIGS. 22 and 26, the pressure-sensing
lumen 343 of first conduit 339 is fluidly coupled to a
pressure-sensing channel 345 at a first end 347. The
pressure-sensing channel 345 is formed in the connector body 332 of
the pouch connector 302. The pressure-sensing channel 345 allows a
fluid to be communicated through the pouch connector 302. A second
end 349 of the pressure-sensing channel 345 is fluidly coupled to a
pressure-sensing lumen (not explicitly shown) in the second conduit
350 that is fluidly coupled to a reduced-pressure unit, e.g.,
therapy unit 110 in FIG. 2, that thereby monitors the pressure at
the tissue site on the animal.
[0116] Although certain illustrative, non-limiting embodiments have
been presented, it should be understood that various changes,
substitutions, permutations, and alterations can be made without
departing from the scope 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. For
example, the bypass conduit shown in one embodiment, e.g., 140 in
FIG. 7, may be used in FIG. 11 or vice versa.
[0117] 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.
[0118] The steps of the methods described herein may be carried out
in any suitable order, or simultaneously where appropriate.
[0119] Where appropriate, features of any of the embodiments
described above may be combined with features of any of the other
embodiments described to form further examples having comparable or
different properties and addressing the same or different
problems.
[0120] 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.
* * * * *
References