U.S. patent application number 16/540336 was filed with the patent office on 2019-12-05 for medical dressing interface devices, systems, and methods.
The applicant listed for this patent is KCI Licensing, Inc.. Invention is credited to Christopher Brian LOCKE, Timothy Mark ROBINSON.
Application Number | 20190366065 16/540336 |
Document ID | / |
Family ID | 56511897 |
Filed Date | 2019-12-05 |
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United States Patent
Application |
20190366065 |
Kind Code |
A1 |
LOCKE; Christopher Brian ;
et al. |
December 5, 2019 |
MEDICAL DRESSING INTERFACE DEVICES, SYSTEMS, AND METHODS
Abstract
An adapter for providing fluid communication with a tissue site
may include a base, a conduit housing, a primary port, at least one
ancillary port, and at least one port extension. The base may
define a mounting plane having a first planar side and a second
planar side opposite the first planar side. The conduit housing may
be supported by the base and may include a recessed region defining
an entry surface. The conduit housing and the recessed region may
be positioned on the first planar side with the entry surface
facing the first planar side. The primary port may be on the entry
surface, and the at least one ancillary port may be on the entry
surface. A distal end of the port extension may be positioned on
the second planar side in fluid communication with the ancillary
port. Other devices, systems, and methods are disclosed.
Inventors: |
LOCKE; Christopher Brian;
(Bournemouth, GB) ; ROBINSON; Timothy Mark;
(Shillingstone, GB) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
KCI Licensing, Inc. |
San Antonio |
TX |
US |
|
|
Family ID: |
56511897 |
Appl. No.: |
16/540336 |
Filed: |
August 14, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15198891 |
Jun 30, 2016 |
10426938 |
|
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16540336 |
|
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62192425 |
Jul 14, 2015 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 13/00068 20130101;
A61M 2205/3344 20130101; A61F 13/00063 20130101; A61F 2013/00174
20130101; A61M 1/0086 20140204; A61M 1/0088 20130101 |
International
Class: |
A61M 35/00 20060101
A61M035/00; A61M 1/00 20060101 A61M001/00; A61F 13/00 20060101
A61F013/00 |
Claims
1. An adapter for providing fluid communication with a distribution
manifold at a tissue site, the adapter comprising: a base defining
a mounting plane, the mounting plane having a first planar side and
a second planar side opposite the first planar side, the base
including a mounting surface coplanar with the first planar side
and facing the first planar side; a conduit housing supported by
the base and including a recessed region defining an entry surface,
the conduit housing and the recessed region positioned on the first
planar side with the entry surface facing the first planar side; a
primary port on the entry surface; at least one ancillary port on
the entry surface; and at least one port extension including a
proximal end, a distal end, and a bore between the proximal end and
the distal end, the distal end of the port extension positioned on
the second planar side in fluid communication with the ancillary
port through the bore.
2. The adapter of claim 1, wherein the base is attached to the
conduit housing and positioned about the recessed region.
3. The adapter of claim 1, wherein the base surrounds the recessed
region.
4. The adapter of claim 1, wherein the entry surface is spaced
apart from the first planar side of the mounting plane.
5. The adapter of claim 1, wherein the primary port is positioned
at an apex of the recessed region.
6. The adapter of claim 5, wherein the apex of the recessed region
is spaced apart from the first planar side of the mounting
plane.
7. The adapter of claim 1, wherein the primary port is spaced apart
from the ancillary port such that the ancillary port is positioned
closer to the first planar side of the mounting plane than the
primary port.
8. The adapter of claim 1, wherein the port extension extends
beyond the mounting surface through the mounting plane to the
second planar side, the mounting surface and the second planar side
configured to face the distribution manifold.
9. The adapter of claim 1, wherein the distal end of the port
extension is spaced apart from the mounting plane on the second
planar side.
10. The adapter of claim 1, wherein the proximal end of the port
extension is positioned on the first planar side of the mounting
plane in fluid communication with the ancillary port, the distal
end of the port extension extending through the mounting plane to
the second planar side.
11. The adapter of claim 1, wherein the port extension is
collapsible in a lengthwise direction.
12. The adapter of claim 1, wherein the proximal end of the port
extension is coupled to the entry surface about the ancillary
port.
13. The adapter of claim 1, wherein the bore of the port extension
defines an isolated communication passageway between the ancillary
port and the distal end of the port extension.
14. The adapter of claim 1, wherein the distal end of the port
extension carries a plurality of castellations, the castellations
comprising projections extending outward from the distal end.
15. The adapter of claim 14, wherein the castellations are disposed
about a perimeter of the distal end of the port extension.
16. The adapter of claim 14, wherein the castellations are
collapsible.
17. The adapter of claim 14, wherein the castellations are spaced
apart from one another about the distal end of the port
extension.
18. The adapter of claim 14, further comprising an opening defined
between each of the castellations and in fluid communication with
the bore.
19. The adapter of claim 1, wherein the at least one ancillary port
comprises a first ancillary port and a second ancillary port, the
port extension coupled to the entry surface about the first
ancillary port and extending outward from the entry surface and
beyond the mounting surface of the base, the second ancillary port
terminating at the entry surface.
20. The adapter of claim 1, wherein the at least one ancillary port
comprises a first ancillary port and a second ancillary port, and
wherein the at least one port extension comprises a first port
extension and a second port extension, the first port extension
coupled about the first ancillary port, and the second port
extension coupled about the second ancillary port.
21. The adapter of claim 1, further comprising channels positioned
on the entry surface to direct liquid away from the ancillary port
and into the primary port.
22. The adapter of claim 21, wherein the channels comprise: a
linear channel section along approximately half of the entry
surface; and a radial channel section along approximately one-third
of the entry surface.
23. The adapter of claim 1, further comprising radial channels
positioned on the base to direct liquid from a periphery of the
base away from the ancillary port.
24. The adapter of claim 23, further comprising an intermediate
collection channel positioned on the base to direct liquid into the
radial channels.
25.-52. (canceled)
53. A method for treating a tissue site, comprising: providing a
distribution manifold comprising a tissue-facing side for facing
the tissue site and an outward-facing side opposite the
tissue-facing side; applying reduced pressure to the outward-facing
side of the distribution manifold; measuring a first pressure at
the tissue-facing side of the distribution manifold; measuring a
second pressure at the outward-facing side of the distribution
manifold; and calculating a difference between the first pressure
and the second pressure to provide a differential pressure.
54. The method of claim 53, further comprising changing the
distribution manifold if the differential pressure is greater than
15 mm Hg.
55. The method of claim 53, further comprising covering the
outward-facing side of the distribution manifold with a drape to
provide a sealed space between the drape and the tissue site, the
distribution manifold positioned in the sealed space.
56. A method for measuring and controlling pressure at a tissue
site, comprising: positioning a distribution manifold adjacent a
surface of the tissue site, the distribution manifold comprising a
tissue-facing side facing the tissue site and an outward-facing
side opposite the tissue-facing side; positioning an adapter
adjacent the distribution manifold, the adapter comprising: a
conduit housing including a recessed region defining an entry
surface, the entry surface facing the outward-facing side of the
distribution manifold, a primary port on the entry surface, a first
ancillary port and a second ancillary port on the entry surface,
and a first port extension and a second port extension, the first
port extension and the second port extension each including a
proximal end, a distal end, and a bore between the proximal end and
the distal end, the distal end of the first port extension in fluid
communication with the first ancillary port, the distal end of the
second port extension in fluid communication with the second
ancillary port; inserting the distal end of the first port
extension and the distal end of the second port extension into the
distribution manifold; applying reduced pressure from a reduced
pressure source to the distribution manifold through the primary
port; measuring a first pressure between the tissue-facing side of
the distribution manifold and the surface of the tissue site
through the first port extension; measuring a second pressure
between the tissue-facing side of the distribution manifold and the
surface of the tissue site through the second port extension; and
controlling the reduced pressure from the reduced pressure source
according to the first pressure and the second pressure.
57. A method for measuring and controlling pressure at a tissue
site, comprising: positioning a distribution manifold adjacent a
surface of the tissue site, the distribution manifold comprising a
tissue-facing side facing the tissue site and an outward-facing
side opposite the tissue-facing side; applying reduced pressure
from a reduced pressure source to the distribution manifold;
measuring a first pressure between the surface of the tissue site
and the tissue-facing side of the distribution manifold; measuring
a second pressure between the surface of the tissue site and the
tissue-facing side of the distribution manifold; and controlling
the reduced pressure from the reduced pressure source according to
the first pressure and the second pressure.
58. The method of claim 57, wherein applying reduced pressure
comprises applying reduced pressure to the outward-facing side of
the distribution manifold.
59. The method of claim 57, further comprising: determining a first
time period for the first pressure to respond to a change in the
reduced pressure at the reduced pressure source; determining a
second time period for the second pressure to respond to the change
in reduced pressure at the reduced pressure source; controlling the
reduced pressure according to the first time period if the first
time period is less than the second time period; and controlling
the reduced pressure according to the second time period if the
second time period is less than the first time period.
60.-62. (canceled)
63. A method for instilling fluid at a tissue site, comprising:
positioning a distribution manifold adjacent a surface of the
tissue site, the distribution manifold comprising a tissue-facing
side facing the tissue site and an outward-facing side opposite the
tissue-facing side; and delivering fluid directly between the
surface of the tissue site and the tissue-facing side of the
distribution manifold.
64. The method of claim 63, further comprising delivering reduced
pressure to the outward-facing side of the distribution
manifold.
65. The method of claim 64, further comprising measuring a pressure
between the surface of the tissue site and the tissue-facing side
of the distribution manifold, and controlling the delivery of
reduced pressure according to the pressure.
66. An adapter for providing fluid communication with a
distribution manifold at a tissue site, the adapter comprising: a
base including a mounting surface; a housing supported by the base
and including an opening extending inbound of the mounting surface;
a primary port in the opening; at least one ancillary port in the
opening; and at least one ancillary fluid pathway extending from
the at least one ancillary port outbound of the mounting
surface.
67. The adapter of claim 66, wherein the at least one ancillary
fluid pathway extends beyond the mounting surface.
68. The adapter of claim 66, wherein the primary port and the at
least one ancillary port are positioned inbound of the mounting
surface and on an interior surface of the opening.
69. The adapter of claim 66, wherein the primary port is spaced
apart from the at least one ancillary port such that the at least
one ancillary port is positioned closer to the mounting surface
than the primary port.
70. The adapter of claim 66, wherein the at least one ancillary
fluid pathway has a proximal end and a distal end, the proximal end
positioned inbound of the mounting surface and the distal end
positioned outbound of the mounting surface.
71. The adapter of claim 66, wherein the opening has an apex
inbound of the mounting surface, and wherein the primary port is
positioned at the apex.
72. The adapter of claim 66, wherein the at least one ancillary
fluid pathway comprises an auxiliary tube including a proximal end,
a distal end, and a bore between the proximal end and the distal
end, the distal end of the auxiliary tube positioned outbound of
the mounting surface and in fluid communication with the ancillary
port through the bore.
73. A method for treating a tissue site, comprising: positioning a
distribution manifold on a surface of the tissue site, the
distribution manifold comprising a tissue-facing side facing the
tissue site and an outward-facing side opposite the tissue-facing
side; providing an adapter, comprising: a conduit housing including
a recessed region defining an entry surface, a primary port on the
entry surface, an ancillary port on the entry surface, and an
ancillary fluid pathway through the conduit housing and extending
outward from the conduit housing; positioning the adapter on the
distribution manifold such that the ancillary port is positioned on
the outward-facing side of the distribution manifold and the
ancillary fluid pathway extends into the distribution manifold.
74. The method of claim 73, wherein the entry surface faces the
outward-facing side of the distribution manifold when the adapter
is positioned on the distribution manifold.
75. The method of claim 73, further comprising: applying reduced
pressure to the distribution manifold through the primary port;
measuring a first pressure through the ancillary fluid pathway;
measuring a second pressure through the ancillary port; and
calculating a difference between the first pressure and the second
pressure to provide a differential pressure.
76. The method of claim 75, wherein the first pressure is measured
between the surface of the tissue site and the tissue-facing side
of the distribution manifold.
77. The method of claim 75, wherein the second pressure is measured
at the outward-facing side of the distribution manifold.
78. The method of claim 75, further comprising changing the
distribution manifold if the differential pressure is greater than
15 mm Hg.
79. (canceled)
Description
RELATED APPLICATIONS
[0001] This application is a divisional of U.S. patent application
Ser. No. 15/198,891, filed Jun. 30, 2016, which claims the benefit,
under 35 USC 119(e), of the filing of U.S. Provisional Patent
Application No. 62/192,425, entitled "Medical Dressing Interface
Devices, Systems, and Methods," filed Jul. 14, 2015, which is
incorporated herein by reference for all purposes.
TECHNICAL FIELD
[0002] This disclosure relates generally to tissue treatment
systems, and more particularly, but without limitation, to medical
dressing interface devices, systems, and methods that may be
suitable for use with reduced-pressure therapy and instillation
therapy.
BACKGROUND
[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 have been 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 or other
tissue with reduced pressure may be commonly referred to as
"reduced-pressure therapy." However, such treatment may also be
known by other names including "negative-pressure therapy,"
"negative-pressure wound therapy," "vacuum therapy,"
"vacuum-assisted closure," and "topical negative-pressure," 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 tissue
site. Together, these benefits can increase development of
granulation tissue and reduce healing times.
[0004] Cleansing a tissue site can also be highly beneficial for
new tissue growth. For example, a tissue site can be washed with a
stream of liquid solution, or a cavity can be washed using a liquid
solution for therapeutic purposes. Further, fluid may be introduced
to a tissue site and left at the tissue site for a prescribed
period of time before removing the fluid. These practices may be
referred to as "irrigation," "lavage," and "instillation."
Instillation of topical treatment solutions over a wound bed or
other tissue site can be combined with reduced-pressure therapy to
further promote healing and tissue growth by loosening soluble
contaminants and removing infectious material. As a result, soluble
bacterial burden can be decreased, contaminants removed, and the
tissue site cleansed.
[0005] Cost and complexity can limit the application of
reduced-pressure therapy and instillation therapy systems.
Development and operation of therapy systems, components, and
processes may benefit manufacturers, healthcare providers, and
patients.
SUMMARY
[0006] New and useful devices, systems, and methods that may be
suitable for use with reduced-pressure therapy and instillation
therapy are set forth in the appended claims. For example, in some
illustrative embodiments, an adapter for providing fluid
communication with a distribution manifold at a tissue site may
include a base, a conduit housing, a primary port, at least one
ancillary port, and at least one port extension. The base may
define a mounting plane having a first planar side and a second
planar side opposite the first planar side. Further, the base may
include a mounting surface coplanar with the first planar side and
facing the first planar side. The conduit housing may be supported
by the base and may include a recessed region defining an entry
surface. The conduit housing and the recessed region may be
positioned on the first planar side with the entry surface facing
the first planar side. The primary port may be on the entry
surface, and the at least one ancillary port may be on the entry
surface. The at least one port extension may include a proximal
end, a distal end, and a bore between the proximal end and the
distal end. The distal end of the port extension may be positioned
on the second planar side in fluid communication with the ancillary
port through the bore.
[0007] In some illustrative embodiments, a system for treating a
tissue site may include a distribution manifold, an adapter, and a
reduced pressure source. The distribution manifold may include a
tissue-facing side adapted to face the tissue site, and an
outward-facing side opposite the tissue-facing side. The adapter
may be for providing fluid communication with the distribution
manifold. The adapter may include a base, a conduit housing, a
primary port, at least one ancillary port, and at least one port
extension. The base may include a mounting surface adapted to be
positioned on the distribution manifold. The conduit housing may be
supported by the base and may include a recessed region defining an
entry surface. The entry surface may be adapted to be positioned
facing the distribution manifold. The primary port may be
positioned on the entry surface, and the at least one ancillary
port may be positioned on the entry surface. The at least one port
extension may include a proximal end, a distal end, and a bore
between the proximal end and the distal end. The distal end of the
port extension may be adapted to extend into the distribution
manifold when the mounting surface is positioned on the
distribution manifold. The distal end of the port extension may
also be in fluid communication with the ancillary port through the
bore. The reduced pressure source may be adapted to be positioned
in fluid communication with the primary port through the conduit
housing
[0008] In some illustrative embodiments, a method for evaluating a
service life of a distribution manifold for treating a tissue site
may include positioning the distribution manifold on a surface of
the tissue site. The distribution manifold may include a
tissue-facing side facing the tissue site, and an outward-facing
side opposite the tissue-facing side. Further, the method may
include positioning an adapter on the distribution manifold. The
adapter may include a conduit housing, a primary port, a first
ancillary port, a second ancillary port, and a port extension. The
conduit housing may include a recessed region defining an entry
surface. The entry surface may face the outward-facing side of the
distribution manifold. The primary port may be on the entry
surface. Further, the first ancillary port and the second ancillary
port may be on the entry surface. The port extension may include a
proximal end, a distal end, and a bore between the proximal end and
the distal end. The distal end of the port extension may be in
fluid communication with the first ancillary port. Further, the
method may include inserting the distal end of the port extension
into the distribution manifold, and applying reduced pressure to
the distribution manifold through the primary port. Further, the
method may include measuring a first pressure between the surface
of the tissue site and the tissue-facing side of the distribution
manifold through the first ancillary port and the distal end of the
port extension. Further, the method may include measuring a second
pressure at the outward-facing side of the distribution manifold
through the second ancillary port. Further, the method may include
calculating a difference between the first pressure and the second
pressure to provide a differential pressure.
[0009] In some illustrative embodiments, a method for treating a
tissue site may include providing a distribution manifold. The
distribution manifold may include a tissue-facing side for facing
the tissue site, and an outward-facing side opposite the
tissue-facing side. Further, the method may include applying
reduced pressure to the outward-facing side of the distribution
manifold. Further, the method may include measuring a first
pressure at the tissue-facing side of the distribution manifold.
Further, the method may include measuring a second pressure at the
outward-facing side of the distribution manifold. Further, the
method may include calculating a difference between the first
pressure and the second pressure to provide a differential
pressure.
[0010] In some illustrative embodiments, a method for measuring and
controlling pressure at a tissue site may include positioning a
distribution manifold adjacent a surface of the tissue site. The
distribution manifold may include a tissue-facing side facing the
tissue site, and an outward-facing side opposite the tissue-facing
side. Further, the method may include positioning an adapter
adjacent the distribution manifold. The adapter may include a
conduit housing, a primary port, a first ancillary port, a second
ancillary port, a first port extension, and a second port
extension. The conduit housing may include a recessed region
defining an entry surface. The entry surface may face the
outward-facing side of the distribution manifold. The primary port
may be on the entry surface. Further, the first ancillary port and
the second ancillary port may be on the entry surface. The first
port extension and the second port extension may each include a
proximal end, a distal end, and a bore between the proximal end and
the distal end. The distal end of the first port extension may be
in fluid communication with the first ancillary port, and the
distal end of the second port extension may be in fluid
communication with the second ancillary port. Further, the method
may include inserting the distal end of the first port extension
and the distal end of the second port extension into the
distribution manifold. Further, the method may include applying
reduced pressure from a reduced pressure source to the distribution
manifold through the primary port. Further, the method may include
measuring a first pressure between the tissue-facing side of the
distribution manifold and the surface of the tissue site through
the first port extension. Further, the method may include measuring
a second pressure between the tissue-facing side of the
distribution manifold and the surface of the tissue site through
the second port extension. Further, the method may include
controlling the reduced pressure from the reduced pressure source
according to the first pressure and the second pressure.
[0011] In some illustrative embodiments, a method for measuring and
controlling pressure at a tissue site may include positioning a
distribution manifold adjacent a surface of the tissue site. The
distribution manifold may include a tissue-facing side facing the
tissue site, and an outward-facing side opposite the tissue-facing
side. Further, the method may include applying reduced pressure
from a reduced pressure source to the distribution manifold.
Further, the method may include measuring a first pressure between
the surface of the tissue site and the tissue-facing side of the
distribution manifold. Further, the method may include measuring a
second pressure between the surface of the tissue site and the
tissue-facing side of the distribution manifold. Further, the
method may include controlling the reduced pressure from the
reduced pressure source according to the first pressure and the
second pressure.
[0012] In some illustrative embodiments, a method for instilling
fluid at a tissue site may include positioning a distribution
manifold adjacent a surface of the tissue site. The distribution
manifold may include a tissue-facing side facing the tissue site,
and an outward-facing side opposite the tissue-facing side.
Further, the method may include positioning an adapter adjacent the
distribution manifold. The adapter may include a conduit housing, a
primary port, at least one ancillary port, and at least one port
extension. The conduit housing may include a recessed region
defining an entry surface. The entry surface may face the
outward-facing side of the distribution manifold. The primary port
may be on the entry surface, and the at least one ancillary port
may be on the entry surface. The at least one port extension may
include a proximal end, a distal end, and a bore between the
proximal end and the distal end. The distal end of the port
extension may be in fluid communication with the ancillary port
through the bore. Further, the method may include inserting the
distal end of the port extension into the distribution manifold,
and delivering fluid to the surface of the tissue site through the
ancillary port and the distal end of the port extension.
[0013] In some illustrative embodiments, a method for instilling
fluid at a tissue site may include positioning a distribution
manifold adjacent a surface of the tissue site. The distribution
manifold may include a tissue-facing side facing the tissue site,
and an outward-facing side opposite the tissue-facing side.
Further, the method may include delivering fluid directly between
the surface of the tissue site and the tissue-facing side of the
distribution manifold.
[0014] In some illustrative embodiments, an adapter for providing
fluid communication with a distribution manifold at a tissue site
may include a base, a housing, a primary port, at least one
ancillary port, and at least one fluid pathway. The base may
include a mounting surface. The housing may be supported by the
base. The housing may include an opening extending inbound of the
mounting surface of the base. The primary port and the at least one
ancillary port may be positioned in the opening. The at least one
ancillary fluid pathway may extend from the at least one ancillary
port outbound of the mounting surface of the base.
[0015] In some embodiments, the at least one ancillary fluid
pathway may extend beyond the mounting surface of the base.
Further, in some embodiments, the primary port and the at least one
ancillary port may be positioned inbound of the mounting surface of
the base and on an interior surface of the opening. Further, in
some embodiments, the primary port may be spaced apart from the at
least one ancillary port such that the at least one ancillary port
is positioned closer to the mounting surface of the base than the
primary port. Further, in some embodiments, the at least one
ancillary fluid pathway may have a proximal end and a distal end.
The proximal end of the at least one ancillary fluid pathway may be
positioned inbound of the mounting surface of the base. The distal
end of the at least one ancillary fluid pathway may be positioned
outbound of the mounting surface of the base. Further, in some
embodiments, the opening of the housing may have an apex positioned
inbound of the mounting surface of the base, and the primary port
may be positioned at the apex. In some embodiments, the at least
one ancillary fluid pathway may include an auxiliary tube. The
auxiliary tube may include a proximal end, a distal end, and a bore
between the proximal end and the distal end. The distal end of the
auxiliary tube may be positioned outbound pf the mounting surface
of the base and in fluid communication with the ancillary port
through the bore.
[0016] In some illustrative embodiments, a method for treating a
tissue site may include positioning a distribution manifold on a
surface of the tissue site. The distribution manifold may include a
tissue-facing side facing the tissue site and an outward-facing
side opposite the tissue-facing side. Further, the method may
include providing an adapter. The adapter may include a conduit
housing, a primary port, an ancillary port, and an ancillary fluid
pathway. The conduit housing may include a recessed region defining
an entry surface. The primary port and the ancillary port may be
positioned on the entry surface. The ancillary fluid pathway may be
disposed through the conduit housing and extend outward from the
conduit housing. Further, the method may include positioning the
adapter on the distribution manifold such that the ancillary port
is positioned on the outward-facing side of the distribution
manifold and the ancillary fluid pathway extends into the
distribution manifold.
[0017] In some embodiments, the entry surface may face the
outward-facing side of the distribution manifold when the adapter
is positioned on the distribution manifold. Further, in some
embodiments, the method may include applying reduced pressure to
the distribution manifold through the primary port; measuring a
first pressure through the ancillary fluid pathway; measuring a
second pressure through the ancillary port; and calculating a
difference between the first pressure and the second pressure to
provide a differential pressure. In some embodiments, the first
pressure may be measured between the surface of the tissue site and
the tissue-facing side of the distribution manifold. Further, in
some embodiments, the second pressure may be measured at the
outward-facing side of the distribution manifold. Further, in some
embodiment, the method may include changing the distribution
manifold if the differential pressure is greater than 15 mm Hg.
[0018] Objectives, advantages, and a preferred mode of making and
using the claimed subject matter may be understood best by
reference to the accompanying drawings in conjunction with the
following detailed description of illustrative embodiments.
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] FIG. 1 is a partially schematic, perspective view of a
reduced pressure wound treatment (RPWT) system including
improvements according to an example embodiment of this
disclosure;
[0020] FIG. 2 is a perspective view of an underside or open side of
an improved adapter according to an example embodiment of this
disclosure;
[0021] FIG. 3 is a plan view of a topside or closed side of the
improved adapter of FIG. 2;
[0022] FIG. 4 is a first side view of the improved adapter of FIG.
2;
[0023] FIG. 5 is an end view of the improved adapter of FIG. 2;
[0024] FIG. 6 is a second side view of the improved adapter of FIG.
2;
[0025] FIG. 7 is a plan view of an underside or open side of the
improved adapter of FIG. 2, the underside configured according to
an example embodiment of this disclosure;
[0026] FIG. 8 is a plan view of an underside or open side of the
improved adapter of FIG. 2, the underside configured according to
another example embodiment of this disclosure;
[0027] FIG. 9 is a detailed view of an example embodiment of a
recessed region of the adapter of FIGS. 7 and 8;
[0028] FIG. 10 is a perspective view of an underside or open side
of an improved adapter illustrating at least one port extension
according to an example embodiment of this disclosure;
[0029] FIG. 11 is a perspective view of an underside or open side
of an improved adapter illustrating at least one port extension
according to another example embodiment of this disclosure;
[0030] FIG. 12A is a perspective view of an example embodiment of a
distribution manifold suitable for use with a RPWT system according
to this disclosure;
[0031] FIG. 12B is a perspective view of another example embodiment
of a distribution manifold suitable for use with a RPWT system
according to this disclosure;
[0032] FIG. 13A is a perspective view of an open end of an improved
delivery tube according to an example embodiment of this
disclosure;
[0033] FIG. 13B is a longitudinal cross-sectional view of the
improved delivery tube of FIG. 13A;
[0034] FIG. 14A is a perspective view of an open end of an improved
delivery tube according to another example embodiment of this
disclosure;
[0035] FIG. 14B is a longitudinal cross-sectional view of the
improved delivery tube of FIG. 14A;
[0036] FIG. 15 is a schematic block diagram illustrating a reduced
pressure system according to an example embodiment of this
disclosure;
[0037] FIG. 16 is a partially schematic, perspective view of a
reduced pressure wound treatment (RPWT) system including
improvements according to another example embodiment of this
disclosure;
[0038] FIG. 17 is a cut-away view of a split connector coupled to a
portion of a delivery tube according to an example embodiment of
this disclosure;
[0039] FIG. 18 is a schematic block diagram illustrating a reduced
pressure system according to another example embodiment of this
disclosure;
[0040] FIG. 19 is a graphical plot of pressure measured at a tissue
site by an adapter according to this disclosure compared to a plot
of actual pressure present at the tissue site; and
[0041] FIG. 20 is a graphical plot of pressure measured at an
outward-facing side of a distribution manifold compared to a plot
of pressure measured at a tissue-facing side of a distribution
manifold according to this disclosure.
DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTS
[0042] The following detailed description of example embodiments
makes reference to the accompanying drawings and provides
sufficient information to enable a person skilled in the art to
make and use the subject matter set forth in the appended claims.
However, the detailed description may omit details known in the
art. Other embodiments may be possible, and structural, mechanical,
electrical, and chemical modifications may be made to the example
embodiments herein without departing from the scope of this
disclosure as defined by the appended claims. Therefore, the
following detailed description is illustrative and
non-limiting.
[0043] Provided are improvements to reduced-pressure therapy and
instillation therapy systems that may include an adapter to improve
operational reliability. For example, the adapter may be configured
to prevent or reduce instances of unintentional liquid ingress into
measurement lumens or sensing lumens associated with a therapy
system. Further, the adapter may be configured to position
measurement lumens, sensing lumens, or instillation lumens, which
may all be referred to as ancillary lumens, closer to a point of
interest at a tissue site, such as a surface of the tissue site.
The lumens may be separate or isolated from communicating with one
another between the point of interest and components, such as,
without limitation, a sensor, an instillation reservoir, or a
reduced pressure source. Such a configuration may increase the
accuracy of pressure measurements at the tissue site, and provide
for efficient use of instillation fluid. Improvements to
reduced-pressure therapy and instillation therapy methodologies are
also provided.
[0044] Herein, the term "tissue site" may broadly refer to a wound,
defect, or other treatment target 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, negative pressure may be applied to
a tissue site to grow additional tissue that may be harvested and
transplanted.
[0045] Although reference may be made to a wound, the devices,
systems, and methodologies herein are provided without limitation
to any particular type of tissue site.
[0046] Further, the term "negative pressure" may refer to a
pressure less than a local ambient pressure, such as the ambient
pressure external to a sealed therapeutic environment that may be
provided by a therapy system, or portion of a therapy system, such
as a dressing. The local ambient pressure may also be the
atmospheric pressure at the location of a tissue site. The pressure
may also be less than a hydrostatic pressure associated with tissue
at the tissue site. Unless otherwise indicated, values of pressure
stated herein are gauge pressures. Further, references to increases
in negative pressure may refer to a decrease in absolute pressure,
while decreases in negative pressure may refer to an increase in
absolute pressure. While the amount and nature of negative pressure
applied to a tissue site may vary according to therapeutic
requirements, the pressure is generally a low vacuum, also commonly
referred to as a rough vacuum, that may be between -5 mm Hg (-667
Pa) and -500 mm Hg (-66.7 kPa). Common therapeutic ranges may be
between -75 mm Hg (-9.9 kPa) and -300 mm Hg (-39.9 kPa).
[0047] Reference is made first to FIG. 1 for a general description
of components that may be included in a reduced pressure wound
treatment (RPWT) system according to an example embodiment of this
disclosure. In some embodiments, a RPWT system 10 may include a
wound dressing 12, a delivery tube 14, and a fluid containment and
instrumentation assembly 16. The fluid containment and
instrumentation assembly 16 may include a fluid container 18 and
instrumentation components 20. Further, the RPWT system 10 may
include an adapter 22 that may be in fluid communication between
the wound dressing 12 and the delivery tube 14. The delivery tube
14 may be in fluid communication between the adapter 22 and the
fluid containment and instrumentation assembly 16. In some
embodiments, the adapter 22 may be included as part of the wound
dressing 12. The RPWT system 10 is shown in FIG. 1 in one
embodiment as a RPWT system 10a. FIG. 16 discloses another
embodiment of the RPWT system 10, referred to as a RPWT system 10b.
References herein to the RPWT system 10 may refer to elements or
components that may be associated with both the RPWT system 10a and
the RPWT system 10b. Further, like reference numerals herein and
among the drawing figures may refer to like elements and
components.
[0048] The wound dressing 12 may include a distribution manifold
24, such as a porous pad or granular foam, and a cover or drape 26
that may secure the distribution manifold 24 at a tissue site 25.
The adapter 22 may provide fluid communication with the
distribution manifold 24, and may be positioned on the distribution
manifold 24 and adhered thereto by, for example, an adhesive
positioned on the adapter 22, the wound drape 26, or a separate
adhesive drape associated with the adapter 22.
[0049] The fluid container 18 may be representative of a container,
canister, pouch, or other storage component suitable for managing
exudates and other fluids withdrawn from the tissue site 25. In
some embodiments, the fluid container 18 may be a rigid container
suitable for collecting, storing, and disposing of fluids.
[0050] The distribution manifold 24 may include any substance or
structure providing a plurality of pathways adapted to collect or
distribute fluid across a tissue site, such as the tissue site 25,
under pressure. For example, the distribution manifold 24 may be
adapted to receive negative pressure from a source and to
distribute negative pressure through multiple apertures across the
tissue site 25, which may have the effect of collecting fluid from
across the tissue site 25 and drawing the fluid toward the source.
In some embodiments, the fluid path may be reversed or a secondary
fluid path may be provided to facilitate delivering fluid across
the tissue site 25.
[0051] In some embodiments, the pathways of the distribution
manifold 24 may be interconnected to improve distribution or
collection of fluids across the tissue site 25. Further, in some
embodiments, the distribution manifold 24 may be a porous foam
material having interconnected cells or pores. For example,
cellular foam, open-cell foam, reticulated foam, porous tissue
collections, and other porous material such as gauze or felted mat
generally include pores, edges, or walls adapted to form
interconnected fluid channels. Liquids, gels, and other foams may
also include or be cured to include apertures and fluid pathways.
In some embodiments, the distribution manifold 24 may additionally
or alternatively comprise projections that form interconnected
fluid pathways. For example, the distribution manifold 24 may be
molded to provide surface projections that define interconnected
fluid pathways.
[0052] In one non-limiting example, the distribution manifold 24
may be an open-cell, reticulated polyurethane foam such as
GranuFoam.RTM. dressing or VeraFlo.RTM. foam, both available from
Kinetic Concepts, Inc. of San Antonio, Tex. Further, in some
embodiments, the distribution manifold 24 may be either hydrophobic
or hydrophilic. In an example in which the distribution manifold 24
may be hydrophilic, the distribution manifold 24 may also wick
fluid away from the tissue site 25, while continuing to distribute
negative pressure to the tissue site 25. The wicking properties of
the distribution manifold 24 may draw fluid away from the tissue
site 25 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.
[0053] The drape 26 may be, for example, an elastomeric film or
membrane that can provide a seal adequate to maintain a negative
pressure at the tissue site 25 for a given negative-pressure
source. The drape 26 may have a high moisture-vapor transmission
rate (MVTR) in some embodiments. For example, the MVTR may be at
least 300 g/m 2 per twenty-four hours in some embodiments. In some
example embodiments, the drape 26 may be a polymer drape, such as a
polyurethane film, that may be permeable to water vapor but
impermeable to liquid. In such an embodiment, the drape 26 may have
a thickness in the range of 25-50 microns. For permeable materials,
the permeability generally should be low enough that a desired
negative pressure may be maintained.
[0054] The delivery tube 14 may include one or more tubing sections
28 which, as an assembled structure, may provide a continuous
conduit between the adapter 22 and a container connector 34 that
may be positioned on the fluid container 18. Liquid and exudates
drawn by the RPWT system 10 may be removed from the delivery tube
14 at the container connector 34 and be retained within the fluid
container 18. Sections of additional tubing in the form of
instrumentation tubing 36 may extend from the container connector
34 to the instrumentation components 20.
[0055] As shown in FIG. 1, in some embodiments, the instrumentation
components 20 may include a reduced pressure source 38, a pressure
sensor such as a first pressure sensor 39, and another pressure
sensor such as a second pressure sensor 40. In other embodiments,
as shown in FIG. 16 and described further below, the
instrumentation components 20 may include the reduced pressure
source 38, the pressure sensor 39, and an instillation reservoir
41. Each of the instrumentation components 20 may be individually
associated with one isolated conduit, tube, or lumen that may
extend from the adapter 22 into the fluid containment and
instrumentation assembly 16.
[0056] As a non-limiting example, the reduced pressure source 38
may be a reservoir of air at a negative pressure, or a manual or
electrically-powered device that can reduce 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. The reduced pressure source 38 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 may further facilitate
therapy. The reduced pressure source may also have one or more
supply ports configured to facilitate coupling and de-coupling to
one or more distribution components.
[0057] Reference is now made to FIGS. 2-9 for further description
of the reduced pressure adapter 22. FIG. 2 illustrates structural
elements within an opening of the adapter 22 that may be adapted to
contact the distribution manifold 24 of the wound dressing 12. The
adapter 22 may include a base 50 and a housing or a conduit housing
62 that may be supported by or coupled to the base 50.
[0058] The base 50 may be adhered to the distribution manifold 24
or to the drape 26 shown in FIG. 1, for example. The base 50 may
include a base aperture 53 that may be positioned over the
distribution manifold 24. Liquids and gases (collectively referred
to as "fluid") may be drawn from the tissue site 25 through the
base aperture 53. The adapter 22 may include channel elements
positioned near and in fluid communication with the base aperture
53. Described further below, the channel elements may direct and
route liquid for drainage while minimizing any interference with
other components of the RPWT system 10, such as the instrumentation
components 20.
[0059] Further, the base 50 may include a mounting surface 33, and
at least a portion of the mounting surface 33 may define a mounting
plane 27. In FIGS. 2 and 4, the mounting plane 27 provides a
reference or datum point for describing features of the adapter 22
in relation to one another. Thus, the mounting plane 27 is provided
for illustration and does not form part of the adapter 22 or
otherwise require any component of the adapter 22 to have a planar
shape. The mounting plane 27 may have a first proximal side or
first planar side 29 and a second distal side or second planar side
31 opposite the first planar side 29. In some embodiments, the
first planar side 29 and the second planar side 31 may each refer
to a space or territory separated by the mounting plane 27. For
example, a first space on the first planar side 29 may be
positioned on an opposite side of the mounting plane 27 from a
second space on the second planar side 31. The mounting surface 33
of the base 50 may be coplanar with the first planar side 29 and
facing the first planar side 29. The mounting surface 33 and the
second planar side 31 may be configured to face or to be positioned
on the distribution manifold 24.
[0060] Continuing with FIG. 2, the conduit housing 62 of the
adapter 22 may include an opening or a recessed region 54. The
opening or recessed region 54 may define an interior surface or an
entry surface 55. The base 50 may be attached to the conduit
housing 62 and positioned about the recessed region 54. In some
embodiments, the base 50 may partially or completely surround the
recessed region 54. The conduit housing 62 and the recessed region
54 may be positioned on the first planar side 29 of the mounting
plane 27 with the entry surface 55 facing the first planar side 29.
Further, the entry surface 55 may be adapted to face the
distribution manifold 24. In some embodiments, the entry surface 55
may be spaced apart from the first planar side 29 of the mounting
plane 27.
[0061] In some embodiments, the opening or recessed region 54 of
the conduit housing 62 may extend in an inbound direction relative
to the mounting surface 33 of the base 50. The inbound direction
may generally be an opposite direction from a direction the
mounting surface 33 is configured to face, such as a facing
direction or outbound direction. The facing direction or outbound
direction of the mounting surface 33 may be configured to face the
tissue site 25 or the distribution manifold 24, for example.
[0062] A primary port 60 and at least one ancillary port, such as a
first ancillary port 56 and a second ancillary port 58, may be
positioned on the entry surface 55. The primary port 60 may be
centrally located or positioned at an apex of the recessed region
54, and the ancillary ports 56, 58 may be positioned near opposing
edges of the base aperture 53. The apex of the recessed region 54
and the primary port 60 may be spaced apart from the first planar
side 29 of the mounting plane 27. In some embodiments, the primary
port 60 may be spaced apart from the ancillary ports 56, 58 such
that the ancillary ports 56, 58 are positioned closer to the first
planar side 29 of the mounting plane 27 than the primary port
60.
[0063] In some embodiments, the conduit housing 62 may include a
primary conduit (not shown) and a pair of ancillary conduits (not
shown) passing through or formed integrally within the conduit
housing 62. A first end of the primary conduit may terminate on the
entry surface 55 at the primary port 60, and a first end of the
ancillary conduits may terminate on the entry surface 55 at the
ancillary ports 56, 58, respectively.
[0064] Further, in some embodiments, the conduit housing 62 may
include a conduit housing aperture 66 that may be adapted to be
coupled in fluid communication with the delivery tube 14. A primary
lumen interface 64 and at least one ancillary lumen interface, such
as ancillary lumen interfaces 48, 49, shown in FIG. 5, may be
positioned within the conduit housing aperture 66. In some
embodiments, the primary lumen interface 64 may be centrally
positioned within the conduit housing aperture 66, and the
ancillary lumen interfaces 48, 49 may be positioned about the
primary lumen interface 64. A second end of the primary conduit may
terminate at the primary lumen interface 64, and a second end of
the ancillary conduits may terminate at the ancillary lumen
interfaces 48, 49, respectively. Thus, the primary lumen interface
64 may be in fluid communication with the primary port 60 through
the primary conduit within the conduit housing 62, and the
ancillary lumen interfaces 48, 49 may respectively be in fluid
communication with the ancillary ports 56, 58 through the ancillary
conduits within the conduit housing 62. Accordingly, the reduced
pressure source 38, shown in FIG. 1, may be positioned in fluid
communication with the primary port 60 through the conduit housing
62, such as, for example, through the primary lumen interface 64.
Similarly, in some embodiments, the first pressure sensor 39 and
the second pressure sensor 40, shown in FIG. 1, may be positioned
in fluid communication with the ancillary ports 56, 58,
respectively, through the conduit housing 62, such as, for example,
through the ancillary lumen interfaces 48, 49, respectively. In
other embodiments, the pressure sensor 39 and the instillation
reservoir 41, shown in FIG. 16, may be positioned in fluid
communication with the ancillary ports 56, 58, respectively,
through the conduit housing 62, such as, for example, through the
ancillary lumen interfaces 48, 49, respectively. Further
embodiments are possible.
[0065] Referring to the topside, plan view of the adapter 22 shown
in FIG. 3, the conduit housing 62 may be elbow shaped in some
embodiments. However, in other embodiments, the conduit housing 62
may be configured at any desired angle, or may extend
perpendicularly from the base 50. Further, as shown in FIG. 3, in
some embodiments, the conduit housing 62 may include an elbow
region 68, and may be centrally positioned relative to the base
50.
[0066] Referring to FIG. 4, in some embodiments, the adapter 22 may
have a low profile configuration with the base 50 defining the
lateral limits of the adapter 22. As indicated above, the base 50
may be directly adhered to the distribution manifold 24, or may be
positioned and adhered using the drape 26 of the wound dressing 12.
The adapter 22 may be positioned on distribution manifold 24 such
that the base aperture 53 (not seen in this view) of the base 50 is
in direct contact with the distribution manifold 24. In the
embodiment of FIG. 4, the primary lumen interface 64 may extend
outward from the conduit housing 62, and may be surrounded by the
conduit housing aperture 66. Conduits may extend through the
substrate material of the adapter 22 between the interfaces 48, 49,
64 and the recessed region 54, as described above. The elbow region
68 may redirect fluid flow from the wound dressing 12, which may be
positioned beneath the adapter 22, to an angle associated with the
primary interface 64 in a manner that may allow the RPWT system 10
to be placed on the wound dressing 12 and be maintained in a low
profile configuration close to a surface of the wound dressing
12.
[0067] Referring to FIG. 5, another view of the adapter 22 and the
configuration of the elbow region 68 and the internal configuration
of the conduit housing 62 are shown. The base 50 and the conduit
housing aperture 66 are positioned as described above in connection
with FIG. 4. The conduit housing 62 may be positioned to receive a
section of tubing for connection to components of the RPWT system
10 as described herein.
[0068] Continuing with FIG. 5, also depicted are the primary lumen
interface 64 and the ancillary lumen interfaces 48 and 49. The
ancillary lumen interfaces 48 and 49 may align with corresponding
lumens in the delivery tube 14 by, for example, placing a primary
lumen 82 in the delivery tube 14 over the primary lumen interface
64 as further described in connection with FIGS. 13A-14B below.
[0069] Referring to FIG. 6, provided is a view of the adapter of
FIG. 4 from an opposite side, illustrating the same components
previously described in connection with FIG. 4, and the symmetry of
the adapter 22 as configured in some embodiments. Unless otherwise
indicated, the adaptor 22 may be constructed of any materials
capable of providing comfort to the patient while maintaining
sufficient rigidity or resilience to maintain the open lumens,
conduits, and passageways that are integral to the adapter 22. In
some embodiments, the adapter 22 may be formed of flexible
materials.
[0070] Referring to FIG. 7, depicted is another view of an
embodiment of the adapter 22 to further illustrate the structure
and function of elements within the recessed region 54 that may
preference liquids and other non-gaseous fluids away from the
ancillary ports 56, 58. The base 50 may substantially or entirely
surround an edge or perimeter of the recessed region 54. The
ancillary ports 56 and 58 are shown positioned as described above.
The primary port 60 can be seen centrally located within the
recessed region 54. Structures within the recessed region 54 that
may serve to conduct liquid into the primary port 60 and the
associated primary conduit, and thereby allow the ancillary ports
56, 58, and the associated ancillary conduits to remain
unobstructed are described in more detail below with respect to
FIG. 9.
[0071] Referring to FIG. 8, depicted is another embodiment of the
base 50, referred to as a base 52, that may be associated with the
adapter 22. The base 52 may include base serrated guide channels
70, perimeter collection channels 72, and intermediate collection
channels 74. In some embodiments, the base serrated guide channels
70, the perimeter collection channels 72, and the intermediate
collection channels 74 may be molded into a mounting surface 33 of
the base 52. The base serrated guide channels 70, the perimeter
collection channels 72, and the intermediate collection channels 74
as configured in FIG. 8 may direct liquid away from the ancillary
ports 56, 58 and into the primary port 60. The base serrated guide
channels 70 may be positioned and oriented on the base 52 to
directly capture and channel a majority of the liquids being drawn
toward or into the adapter 22. The base serrated guide channels 70
may be spaced and radially-oriented to funnel liquids away from the
ancillary ports 56, 58 and into the primary port 60. In addition,
the perimeter collection channels 72 and the intermediate
collection channels 74 may redirect the flow of liquids among
portions of the base serrated guide channels 70 and away from the
ancillary ports 56, 58. An example of this redirected flow is shown
in FIG. 8 with bolded flow indication arrows, where the radial
channels 70 or the base serrated guide channels 70 are positioned
on the base 52 to direct liquid from a periphery of the base 52
away from the ancillary ports 56, 58. Further, the intermediate
collection channels 74 may be positioned on the base 52 to direct
liquid into the radial channels 70 or the base serrated guide
channels 70.
[0072] Reference is now made to FIG. 9 for further description of
the features and elements that may be contained within the recessed
region 54 of the conduit housing 62. These features may be
positioned on the entry surface 55 of the recessed region 54, and
may be configured to preference liquids and other non-gaseous
exudates away from the ancillary ports 56, 58 and into the primary
port 60. As shown, in some embodiments, the primary port 60 may be
centrally positioned within the recessed region 54, and may extend
from this central location to one side of the recessed region 54.
Further, the ancillary ports 56 and 58 may be positioned to either
side of the primary port 60. As shown, in some embodiments, the
ancillary ports 56 and 58 may be circular openings and may have
raised circumferential edges.
[0073] Various elements shown in the embodiment of FIG. 9 may be
positioned to preference liquid into the primary port 60 of the
adapter 22. For example, the ancillary ports 56 and 58 may be
positioned near a perimeter of the base aperture 53 (shown in FIG.
7) and the recessed region 54, and at a level that may be close to
a surface of the distribution manifold 24 when the adapter 22 is
positioned thereon. Accordingly, when the adapter 22 is positioned
on the wound dressing 12, the ancillary ports 56 and 58 may be in
contact, or nearly in contact, with the surface of the distribution
manifold 24. Such a configuration may minimize the likelihood of
splashed or agitated liquid being directed into the ancillary ports
56 and 58.
[0074] Additional elements that may direct liquids into the primary
port 60 are structural serrated channels that may be formed on
portions of the entry surface 55 of the recessed region 54. A first
linear serrated channel section 42 may be positioned in association
with an approximately half-circle section of the recessed region 54
that may be associated with the ancillary port 58. The material
comprising this section of the recessed region 54 may form a
ceiling covering and containing the conduit (not shown) that may
extend within the conduit housing 62 between the ancillary port 58
and one of the ancillary lumen interfaces 48, 49 shown in FIG. 5.
This ceiling may be configured with an array of serrated channels
or striations that may direct liquids that fall upon this surface
toward the primary port 60 within the recessed region 54. Any
liquids that may fall upon this portion of the entry surface 55 may
be channeled directly into the primary port 60, rather than being
directed into the ancillary port 58.
[0075] Continuing with FIG. 9, a similar configuration may be
constructed in an approximately one-third circular radial serrated
channel section 44. Insofar as no internal conduit is contained
within this section of the recessed region 54, the radial serrated
channel section 44 may extend deeper and more directly to the
primary port 60. The radial serrated channel section 44 may extend
from a perimeter of the recessed region 54 toward an apex of the
recessed region 54 that drains into the primary port 60. Further,
the radial serrated channel section 44 may extend from the
ancillary port 58 radially around approximately a one-third
circular portion of the recessed region 54 to the ancillary port
56. Any liquids that fall upon the radial serrated channel section
44 of the recessed region 54 may be directed to the primary port
60, rather than being conducted to either of the ancillary ports
56, 58.
[0076] Further, a wall section that supports the ancillary port 56
at the point at which the ancillary port 56 overhangs the primary
port 60 may include serrated or striated channels 46. For the
orientation shown in FIG. 9, the serrated or striated channels 46
may extend downward from the opening of the ancillary port 56
toward the opening of the primary port 60.
[0077] As described above, various elements of the recessed region
54 may be configured to draw liquid from within the recessed region
54 and to direct the liquid toward the primary port 60. Insofar as
the configuration of the recessed region 54 provides little or no
suction at the ancillary ports 56, 58, the likelihood of
obstructions in the form of liquid or material blocking the
ancillary lumens 56, 58 may be greatly reduced.
[0078] Referring to FIGS. 10-11, in some embodiments, the adapter
22 may include at least one auxiliary tube or port extension 37
that may define, form, or provide an ancillary fluid pathway that
may extend beyond or outbound of the mounting surface 33 of the
base 50. Features described in reference to the port extension 37
herein may be applicable to or interchangeable with the auxiliary
tube and the ancillary fluid pathway. Each of the port extensions
37 may include a proximal end 43, a distal end 45, and a bore 47
between the proximal end 43 and the distal end 45. In some
embodiments, a length of the port extension 37 between the proximal
end 43 and the distal end 45 may be between about 6 millimeters to
about 8 millimeters. The proximal end 43 of the port extension 37
may be positioned on or at the first planar side 29 of the mounting
plane 27, shown in FIG. 1, in fluid communication with one or more
of the ancillary ports 56, 58. In some embodiments, the proximal
end 43 of the port extension 37 may be coupled to the entry surface
55 about one or more of the ancillary ports 56, 58.
[0079] The distal end 45 of the port extension 37 of FIGS. 10-11
may extend through the mounting plane 27 to the second planar side
31 or beyond the second planar side 31. Thus, the port extension 37
may extend beyond the mounting surface 33 through the mounting
plane 27 to the second planar side 31 of the mounting plane 27.
Further, the distal end 45 of the port extension 37 may be
positioned on the second planar side 31, or beyond the second
planar side 31, and in fluid communication with one or more of the
ancillary ports 56, 58 through the bore 47. In some embodiments,
the bore 47 of the port extension 37 may define an isolated
communication passageway between one or more of the ancillary ports
56, 58 and the distal end 45 of the port extension 37. Further, the
distal end 45 of the port extension 37 may be spaced apart from the
mounting plane 27 on the second planar side 31.
[0080] In some embodiments, the port extension 37 may be
collapsible or adjustable in a lengthwise direction. For example,
in some embodiments, the port extension 37 may be formed of
resilient or flexible materials, such as, without limitation a soft
polymer or plasticized PVC material. Such materials may permit the
port extension 37 to adjust or conform to different shapes and
contours at the tissue site 25 while the bore 47 of the port
extension 37 remains open or unobstructed. For example, the distal
end 45 of the port extension 37 may be moveable in a lengthwise
direction along an axis of the bore 47 closer to and farther away
from the mounting plane 27 and the coplanar mounting surface 33.
Further, in some embodiments, the port extension 37 may carry or be
formed with a bellows or corrugation (not shown) configured to
permit a wall of the port extension 37 to collapse without
restricting fluid communication through the bore 47 of the port
extension 37.
[0081] In some embodiments, the distal end 45 of the port extension
37 may carry a plurality of castellations 57. In some embodiments,
the castellations 57 may be projections extending outward from the
distal end 45 of the port extension 37. Further, in some
embodiments, the castellations 57 may be disposed about a perimeter
of the distal end 45 of the port extension 37. Further, in some
embodiments, the castellations 57 may be collapsible in an
analogous manner as described above for the port extension 37.
Further, in some embodiments, the castellations 57 may be spaced
apart from one another about the distal end 45 of the port
extension 37. Further, in some embodiments, an opening 59 may be
defined between each of the castellations 57. The opening 59 may be
in fluid communication with the bore 47 of the port extension 37,
for example, to enhance pressure measurement or instillation of
fluids through the port extension 37 when the distal end 45 of the
port extension 37 is in contact with or in close proximity to a
surface of the tissue site 25. Further, in some embodiments, the
castellations 57 may have a pitch or spacing of about 0.5
millimeters to about 1.0 millimeters between one another. Such a
pitch or spacing may provide a suitable amount of micro-force
deformation at the tissue site 25, which may promote healing and
the formation of granulation tissue.
[0082] In some embodiments, the distal end 45 of the port extension
37 may carry a plurality of apertures or holes (not shown) disposed
through a wall of the port extension 37. These apertures or holes
may be positioned near the distal end 45 and about a perimeter of
the port extension 37. Further, the apertures or holes may be
spaced apart from one another about a perimeter or circumference of
the port extension 37. Analogous to the opening 59 between the
castellations 57, the apertures or holes may be in fluid
communication with the bore 47 of the port extension 37 to enhance
pressure measurement or instillation of fluids through the port
extension 37 when the distal end 45 of the port extension 37 is in
contact with or in close proximity to a surface of the tissue site
25.
[0083] Referring to FIG. 10, in some embodiments, the at least one
port extension 37 may include a first port extension 37a and a
second port extension 37b. The proximal end 43 of the first port
extension 37a may be coupled about the first ancillary port 56, and
the proximal end 43 of the second port extension 37b may be coupled
about the second ancillary port 58. The first pressure sensor 39,
shown in FIG. 1, may be in fluid communication with the first
ancillary port 56 and the first port extension 37a. In some
embodiments, the second pressure sensor 40, also shown in FIG. 1,
may be in fluid communication with the second ancillary port 58 and
the second port extension 37b. In other embodiments, the
instillation reservoir 41, shown in FIG. 16, may be in fluid
communication with the second ancillary port 58 and the second port
extension 37b. Other embodiments are possible.
[0084] Referring to FIG. 11, in some embodiments, the port
extension 37 may be a single port extension 37 coupled to the entry
surface 55 about the first ancillary port 56. For example, the
proximal end 43 of the port extension 37 may be coupled to the
entry surface 55 about the first ancillary port 56. Further, the
distal end 45 of the port extension 37 may extend outward from the
entry surface 55 and beyond the mounting surface 33 of the base 50
or the base 52. The second ancillary port 58 may terminate at the
entry surface 55. In some embodiments, the first pressure sensor
39, shown in FIG. 1, may be positioned in fluid communication with
the first ancillary port 56 and the port extension 37 through the
conduit housing 62. Further, the second pressure sensor 40, also
shown in FIG. 1, may be positioned in fluid communication with the
second ancillary port 58 at the entry surface 55 through the
conduit housing 62.
[0085] Referring to FIGS. 12A-12B, the distribution manifold 24 may
include additional elements for enhancing the RPWT system 10 and
the usability of the adapter 22. For example, the distribution
manifold 24 may include a tissue-facing side 61 adapted to face the
tissue site 25, shown in FIG. 1, and an outward-facing side 63
opposite the tissue-facing side 61. In some embodiments, the
tissue-facing side 61 of the distribution manifold 24 may be
adapted to directly or substantially contact the tissue site 25.
The drape 26, also shown in FIG. 1, may be adapted to cover the
outward-facing side 63 of the distribution manifold 24 at the
tissue site 25.
[0086] Continuing with FIGS. 12A-12B, with reference to FIGS. 8 and
10-11, the mounting surface 33 of the base 50 or the base 52 may be
adapted to be positioned on the outward-facing side 63 of the
distribution manifold 24. The distal end 45 of the port extension
37 may be adapted to extend into or to be pressed into the
distribution manifold 24 when the mounting surface 33 of the base
50 or the base 52 is positioned on the distribution manifold 24.
Further, a length of the port extension 37 may be adapted to extend
between the outward-facing side 63 and the tissue-facing side 61 of
the distribution manifold 24. In some embodiments, the proximal end
43 of the port extension 37 may be adapted to be positioned at the
outward-facing side 63 of the distribution manifold 24, and the
distal end 45 of the port extension 37 may be adapted to be
positioned at the tissue-facing side 61 of the distribution
manifold 24. Further, in some embodiments, the distal end 45 of the
port extension 37 may be adapted to contact the tissue site 25.
[0087] Referring to FIG. 12A, in some embodiments, the distribution
manifold 24 may be a distribution manifold 24a formed, for example,
of a sheet or block of any of the materials described above for the
distribution manifold 24, which may be cut or otherwise shaped to
fit the tissue site 25, shown in FIG. 1. Referring to FIG. 12B, in
some embodiments, the distribution manifold 24 may be a
distribution manifold 24b including a plurality of port apertures
65 sized, spaced, or otherwise adapted to receive the least one
port extension 37. In some embodiments, the port apertures 65 may
have a diameter between about 2 millimeters to about 3 millimeters,
and a pitch or spacing between about 10 millimeters to about 12
millimeters. The plurality of port apertures 65 may be disposed
through a thickness of the distribution manifold 24b, for example,
between the outward-facing side 63 and the tissue-facing side 61.
In some embodiments, the thickness of the distribution manifold 24a
or 24b may be about 30 millimeters.
[0088] Reference is now made to FIGS. 13A-14B for further
description of the delivery tube 14. In some embodiments, the
delivery tube 14 may include the primary lumen 82 and at least one
ancillary lumen, such as, for example, a first ancillary lumen 84
and a second ancillary lumen 86. Further, in some embodiments, the
delivery tube 14 may be a multi-lumen tube 80, such as, for
example, a multi-lumen tube 80a, shown in FIGS. 13A-13B, or a
multi-lumen tube 80b, shown in FIGS. 14A-14B. The multi-lumen tubes
80a, 80b may also be used as one or more tubing sections 28 and the
instrumentation tubing 36 shown and described in connection with
FIGS. 1 and 16. In other embodiments, the delivery tube 14 may be
comprised of single or individual lumens that may be routed or
coupled separate from one another to various components of the RPWT
system 10 described herein.
[0089] The primary lumen 82 may be adapted to be in fluid
communication between the reduced pressure source 38 and the
primary port 60 of the adapter 22 through, for example, the primary
conduit within the adapter 22, described above. Further, the at
least one ancillary lumen 84, 86 may be adapted to be in fluid
communication with one or more of the ancillary ports 56, 58 of the
adapter 22 through, for example, the ancillary conduits of the
adapter 22, also described above. In some embodiments, the
cross-sectional diameter of the primary lumen 82 may be larger or
greater than a cross-sectional diameter of the ancillary lumens 84
and 86.
[0090] Referring to FIGS. 13A-13B, in some embodiments, the
multi-lumen tube 80a may have an oval cross-section, which may
enhance flexibility while precluding the collapse of any of the
described lumens. Further, this oval cross-sectional shape may also
orient the ancillary lumens 84, 86 in appropriate alignment with
the ancillary lumen interfaces 48, 49 of the adapter 22 described
above.
[0091] Referring to FIGS. 14A-14B, in some embodiments, the first
ancillary lumen 84 may be a first pair of ancillary lumens 84a,
84b, and the second ancillary lumen 86 may be a second pair of
ancillary lumens 86a, 86b. The first pair of ancillary lumens 84a,
84b may be adapted to be in fluid communication with the first
ancillary port 56, shown in FIG. 2, and the second pair of
ancillary lumens 86a, 86b may be adapted to be in fluid
communication with the second ancillary port 58, also shown in FIG.
2. As shown in FIGS. 14A-14B, the primary lumen 82, the first pair
of ancillary lumens 84a, 84b, and the second pair of ancillary
lumens 86a, 86b may form part of the multi-lumen tube 80b.
[0092] In some embodiments, the multi-lumen tube 80b may also
include an alignment tab 85 configured or positioned on an exterior
of the multi-lumen tube 80b to orient the ancillary lumens 84, 86
in appropriate alignment with the ancillary lumen interfaces 48, 49
of the adapter 22 described above. In other embodiments, a colored
line, dots, dashes, or emboss may be used alternatively or in
addition to the alignment tab 85. For example, the first pair of
ancillary lumens 84a, 84b may be aligned with one of the ancillary
lumen interfaces 48, 49, and the second pair of the ancillary
lumens 86a, 86b may be aligned with the other of the ancillary
lumens interfaces 48, 49. The ancillary lumen interfaces 48, 49 are
best viewed in FIG. 5, with reference to FIGS. 14A-14B. In the
embodiment shown in FIG. 5, the ancillary lumen interfaces 48, 49
may each include an arcuate passageway shaped to mate with one pair
of the ancillary lumens shown in FIGS. 14A-14B, such as the first
pair of ancillary lumens 84a, 84b or the second pair of ancillary
lumens 86a, 86b. Further, the arcuately shaped passageway of the
ancillary lumen interfaces 48, 49, shown in FIG. 5, may also be
configured to mate with the ancillary lumens 84, 86 in the
multi-lumen tube 80a, shown in FIGS. 13A-13B, with an oval
cross-section. Thus, the configuration of the ancillary lumen
interfaces 48, 49 provides for the use of both the cross-section of
the multi-lumen tube 80a, shown in FIG. 13B, and the cross-section
of the multi-lumen tube 80b, shown in FIG. 14B, in the RPWT system
10.
[0093] FIG. 15 is a schematic diagram illustrating additional
details that may be associated with some example embodiments of the
RPWT system 10a. FIG. 15 illustrates the reduced pressure source
38, the first pressure sensor 39, and the second pressure sensor 40
in separate fluid communication, for example, through separate
lumens or conduits, with the adapter 22 as previously described.
The RPWT system 10a may additionally include a controller 90, and
solenoid valves 92, 94, and 96. The controller 90 may be configured
to receive pressure data from the first pressure sensor 39, the
second pressure sensor 40, and the reduced pressure source 38. The
controller 90 may also be programmed or configured to monitor
pressure at the tissue site 25, shown in FIG. 1, through the
pressure data received from the pressure sensors 39, 40. The
controller 90 may further be configured to operate the reduced
pressure source 38 for supplying reduced pressure to the adapter
22, such as through the previously described primary lumen 82 and
primary port 60, according to the pressure data.
[0094] In some embodiments, the solenoid valve 92 may be in fluid
communication with the first pressure sensor 39, the solenoid valve
94 may be in fluid communication with the second pressure sensor
40, and the solenoid valve 96 may be in fluid communication with
the reduced pressure source 38. The controller 90 may be
electrically coupled or operable on the solenoid valves 92, 94, and
96, and the reduced pressure source 38. In the RPWT system 10a, the
solenoid valves 92, 94, and 96 may be controlled by the controller
90, for example, to regulate pressure at the tissue site 25, and to
clear blockages.
[0095] For example, in instances where liquid or other non-gaseous
substance enters one of the ancillary lumens 84, 86, a blockage may
be created, causing a delay in a pressure change response time of
the ancillary lumen having the blockage versus the ancillary lumen
free of the blockage. The delay may increase as the blockage
increases in severity. When a delay is detected, the RPWT system
10a may control the pressure at the tissue site 25 according to the
pressure data received from the ancillary lumen free of the
blockage. Further, the RPWT system 10a may attempt to clear the
blockage by opening a corresponding solenoid valve 92, 94 to
atmosphere. If the RPWT system 10a is not successful in clearing
the blockage, the RPWT system 10a may ignore any pressure data
received from the ancillary lumen with the blockage, and operate
based on the pressure data received from the ancillary lumen free
of the blockage.
[0096] Referring to FIG. 16, provided is another embodiment of the
RPWT system 10, referred to as the RPWT system 10b. The
instrumentation components 20 of the RPWT system 10b may include
the reduced pressure source 38, the pressure sensor 39, and the
instillation reservoir 41. A split connector 76 may be optionally
employed with the RPWT system 10b to couple the wound dressing 12
in fluid communication with the instillation reservoir 41. The
instillation reservoir 41 may be representative of a container,
canister, pouch, bag, or other storage component suitable for
holding a liquid and for providing a solution for instillation
therapy. The instillation reservoir 41 may be positioned in fluid
communication with at least one of the ancillary ports 56, 58
through the conduit housing 62. Compositions of instillation
solution may vary according to a prescribed therapy, but examples
of suitable solutions may include hypochlorite-based solutions,
silver nitrate (0.5%), sulfur-based solutions, biguanides, cationic
solutions, and isotonic solutions. Like reference numerals
appearing in FIG. 16 and in other figures may have analogous
structure and functionality as previously described components, and
thus, will not be further described.
[0097] Referring to FIG. 17, the split connector 76 may be
configured to separate out at least one of the ancillary lumens 84,
86 associated with the delivery tube 14 when the delivery tube 14
is configured as a multi-lumen tube, such as the multi-lumen tube
80a, 80b. A tubing section 28 of the delivery tube 14 is shown in
FIG. 17 mated to a connector port 88a of the split connector 76 for
purposes of illustration. In some embodiments, one of the ancillary
lumens 84, 86, such as the second ancillary lumen 86, may be
coupled in fluid communication with the instillation reservoir 41,
shown in FIG. 16, through the split connector 76. For example, the
split connector 76 may include a first ancillary passageway 78, a
second ancillary passageway 81, and a primary passageway 83. As
shown in FIG. 17, the first ancillary lumen 84 may be in fluid
communication with the first ancillary passageway 78, the second
ancillary lumen 86 may be in fluid communication with the second
ancillary passageway 81, and the primary lumen 82 may be in fluid
communication with the primary passageway 83. In some embodiments,
the first ancillary passageway 78 may be adapted to be in fluid
communication with the first pair of ancillary lumens 84a, 84b,
shown in FIG. 14A, and the second ancillary passageway 81 may be
adapted to be in fluid communication with the second pair of
ancillary lumens 86a, 86b, also shown in FIG. 14A. The second
ancillary passageway 81 may be coupled in fluid communication with
another tubing section 28 of the delivery tube 14, such as the
instrumentation tubing 36 or the multi-lumen tubes 80a, 80b, at a
connector port 88b of the split connector 76. Further, an
additional tubing section 28 of the delivery tube 14 may be coupled
at a connector port 88c of the split connector 76 to provide fluid
communication with the primary lumen 82 and the first ancillary
lumen 84 through the primary passageway 83 and the first ancillary
passageway 78, respectively. When the multi-lumen tubes 80a, 80b
are used with the split connector 76, the connector ports 88a, 88b,
and 88c may be configured to provide fluid communication with the
lumens described above while blocking fluid communication with
other lumens.
[0098] FIG. 18 is a schematic diagram illustrating additional
details that may be associated with some example embodiments of the
RPWT system 10b. FIG. 18 illustrates the reduced pressure source
38, the pressure sensor 39, and the instillation reservoir 41 in
separate fluid communication, for example, through separate lumens
or conduits, with the adapter 22 as previously described. The RPWT
system 10b may additionally include the controller 90, and the
solenoid valves 92, 94, and 96. The controller 90 may be configured
to receive pressure data from the pressure sensor 39 and the
reduced pressure source 38. The controller 90 may also be
programmed or configured to monitor pressure at the tissue site 25,
shown in FIG. 16, through the pressure data received from the
pressure sensor 39. The controller 90 may further be configured to
operate the reduced pressure source 38 for supplying reduced
pressure to the adapter 22, such as through the previously
described primary lumen 82 and primary port 60, according to the
pressure data. Additionally, the controller 90 may further be
configured to control fluid flow from the instillation reservoir 41
to the adapter 22, such as through the previously described second
ancillary lumen 86 and second ancillary port 58.
[0099] In some embodiments, the solenoid valve 92 may be in fluid
communication with the pressure sensor 39, the solenoid valve 94
may be in fluid communication with the instillation reservoir 41,
and the solenoid valve 96 may be in fluid communication with the
reduced pressure source 38. The controller 90 may be electrically
coupled or operable on the solenoid valves 92, 94, and 96, and the
reduced pressure source 38. In the RPWT system 10b, the solenoid
valves 92, 94, and 96 may be controlled by the controller 90, for
example, to regulate pressure at the tissue site 25 and to clear
blockages as described above. Further, the solenoid valve 94 may
have various configurations for delivering instillation fluid from
the instillation reservoir 41. As shown in FIG. 18, the
instillation reservoir 41 may be positioned in fluid communication
between the solenoid valve 94 and the second ancillary lumen 86. In
such an embodiment, the controller 90 may be operable to open the
solenoid valve 94 to atmosphere, thereby releasing vacuum in the
instillation reservoir 41, permitting instillation fluid in the
instillation reservoir 41 to flow into the second ancillary lumen
86 toward the adapter 22. In other embodiments, the solenoid valve
94 may be positioned in fluid communication between the
instillation reservoir 41 and the second ancillary lumen 86 such
that opening the solenoid valve 94 may permit instillation fluid to
flow from the instillation reservoir 41 by operation of gravity.
Other embodiments are possible, and other actuation devices, such
as a pump, may be associated with the fluid instillation reservoir
41 to enhance the flow of instillation fluid toward the adapter
22.
[0100] Referring to FIG. 19, test results are shown as a graphical
plot of pressure measured at a tissue site by embodiments of the
adapter 22 including the at least one port extension 37, shown in
FIGS. 10-11, compared to a plot of actual pressure present at the
tissue site. In FIG. 19, a solid plot line represents the pressure
measured by the adapter 22, and a dashed plot line represents the
actual pressure measured at the tissue site as a control or
baseline. Both the solid and dashed plot lines substantially
overlap one another in FIG. 19, indicating that the pressure
measured by the adapter 22 provides an accurate representation of
the actual pressure at the tissue site.
[0101] The use of the at least one port extension 37 may contribute
to the accuracy of the pressure measured by the adapter 22. For
example, pressure sampling with the port extension 37 occurs at the
distal end 45 of the port extension 37, which is adapted to be in
contact with or in close proximity to a surface of the tissue site.
Sampling pressure through the distal end 45 of the port extension
37, positioned in contact with or in close proximity to the tissue
site, may minimize variations in pressure measurements that could
occur, for example, due to pressure drops or other losses. Further,
the use of the port extension 37 provides additional benefits in
regard to efficient use of instillation fluid and improved washing
of a tissue site with the instillation fluid. For example,
delivering instillation fluid through the distal end 45 of the port
extension 37, positioned in contact with or in close proximity to
the tissue site, may minimize loss of instillation fluid to other
parts of the system, such as, for example, the dressing and the
distribution manifold. Thus, the port extension 37 may permit
instillation fluid to be delivered directly to a surface of the
tissue site without requiring, for example, saturation of the
distribution manifold or filling of the wound dressing before the
instillation fluid is able to reach a surface of the tissue
site.
[0102] Referring to FIG. 20, test results are shown as a graphical
plot of pressure measured at an outward-facing side of a
distribution manifold by an embodiment of the adapter 22 including
a single port extension 37, shown in FIG. 11, compared to a plot of
pressure measured at a tissue-facing side of the distribution
manifold. In FIG. 20, a solid plot line represents pressure
measured at an outward-facing side of the distribution manifold,
such as through the second ancillary port 58 of the adapter 22,
shown in FIG. 11, which may be adapted to terminate or reside at or
on the outward-facing side of the distribution manifold. A dashed
plot line in FIG. 20 represents the pressure measured through the
adapter 22 and the distal end 45 of the port extension 37, which
may be positioned at the tissue-facing side of the distribution
manifold and in contact with or in close proximity to the tissue
site, providing an accurate representation of the actual pressure
at the tissue site as described above. FIG. 20 illustrates a mean
pressure difference of about 7 mm Hg between the solid plot line
and the dashed plot line, indicating a pressure drop or loss exists
across a thickness of the distribution manifold between the
outward-facing side and the tissue-facing side. As fluid and
particulate exposure from the tissue site to the distribution
manifold occurs over time, increases in pressure drop and losses
can occur, reducing a life expectancy of the distribution manifold.
Thus, the life expectancy of the distribution manifold may be
determined by comparing the pressure measured at the outward-facing
side of the distribution manifold to the pressure measured at the
tissue-facing side of the distribution manifold.
[0103] Referring generally to the figures, this disclosure provides
methods that may be suitable for use with instillation therapy and
reduced-pressure therapy. In some illustrative embodiments, a
method for evaluating a service life of a distribution manifold for
treating a tissue site may include positioning the distribution
manifold 24 on a surface of the tissue site 25. Further, the method
may include positioning the adapter 22 including the port extension
37, as shown in FIG. 11, for example, on the distribution manifold
24. In such an embodiment, the distal end 45 of the port extension
37 may extend outward from the entry surface 55 toward the
tissue-facing side 61 of the distribution manifold 24, and the
second ancillary port 58 may terminate on the entry surface 55 at
the outward-facing side 63 of the distribution manifold 24.
[0104] Further, the method may include inserting the distal end 45
of the port extension 37 into the distribution manifold 24, and
applying reduced pressure to the distribution manifold 24 through
the primary port 60 of the adapter 22. Further, the method may
include measuring a first pressure between the surface of the
tissue site 25 and the tissue-facing side 61 of the distribution
manifold 24 through the first ancillary port 56 and the distal end
45 of the port extension 37. Further, the method may include
measuring a second pressure at the outward-facing side 63 of the
distribution manifold 24 through the second ancillary port 58.
Further, the method may include calculating a difference between
the first pressure and the second pressure to provide a
differential pressure.
[0105] In some embodiments, the method may include changing or
replacing the distribution manifold 24 if the differential pressure
is greater than about 15 mm Hg. Further, in some embodiments,
applying reduced pressure may include applying reduced pressure to
the outward-facing side 63 of the distribution manifold 24.
Further, in some embodiments, the bore 47 of the port extension may
define an isolated communication passageway between the distal end
45 of the port extension 37 and the first ancillary port 56.
Further, in some embodiments, applying reduced pressure to the
distribution manifold 24 may move the outward-facing side 63 of the
distribution manifold 24 closer to the surface of the tissue site
25 such that the distal end 45 of the port extension 37 contacts
the surface of the tissue site 25. Further, in some embodiments,
the method may include covering the outward-facing side 63 of the
distribution manifold 24 with the drape 26 to provide a sealed
space between the drape 26 and the tissue site 25. The distribution
manifold 24 may be positioned in the sealed space.
[0106] In other embodiments, a method for evaluating a service life
of a distribution manifold for treating a tissue site may include
positioning the distribution manifold 24 on a surface of the tissue
site 25. Further, the method may include applying reduced pressure
to the outward-facing side 63 of the distribution manifold 24.
Further, the method may include measuring a first pressure between
the surface of the tissue site 25 and the tissue-facing side 61 of
the distribution manifold 24. Further, the method may include
measuring a second pressure at the outward-facing side 63 of the
distribution manifold 24. Further, the method may include
calculating a difference between the first pressure and the second
pressure to provide a differential pressure.
[0107] In some illustrative embodiments, a method for measuring and
controlling pressure at a tissue site may include positioning the
distribution manifold 24 adjacent a surface of the tissue site 25.
The distribution manifold 24 may include a tissue-facing side 61
facing the tissue site 25, and an outward-facing side 63 opposite
the tissue-facing side 61. Further, the method may include
positioning the adapter 22 adjacent the distribution manifold 24.
In such an embodiment, the adapter 22 may include the first
ancillary port 56, the second ancillary port 58, the first port
extension 37a, and the second port extension 37b as shown in FIG.
10.
[0108] Further, the method may include inserting the distal end 45
of the first port extension 37a and the distal end 45 of the second
port extension 37b into the distribution manifold 24. Further, the
method may include applying reduced pressure from the reduced
pressure source 38 to the distribution manifold 24 through the
primary port 60. Further, the method may include measuring a first
pressure between the tissue-facing side 61 of the distribution
manifold 24 and the surface of the tissue site 25 through the first
port extension 37a. Further, the method may include measuring a
second pressure between the tissue-facing side 61 of the
distribution manifold 24 and the surface of the tissue site 25
through the second port extension 37b. Further, the method may
include controlling the reduced pressure from the reduced pressure
source 38 according to the first pressure and the second
pressure.
[0109] In other embodiments, a method for measuring and controlling
pressure at a tissue site may include positioning the distribution
manifold 24 adjacent a surface of the tissue site 25. The
distribution manifold 24 may include the tissue-facing side 61
facing the tissue site 25, and an outward-facing side 63 opposite
the tissue-facing side 61. Further, the method may include applying
reduced pressure from the reduced pressure source 38 to the
distribution manifold 24. In some embodiments, applying reduced
pressure may include applying reduced pressure to the
outward-facing side 63 of the distribution manifold 24. Further,
the method may include measuring a first pressure between the
surface of the tissue site 25 and the tissue-facing side 61 of the
distribution manifold 24. Further, the method may include measuring
a second pressure between the surface of the tissue site 25 and the
tissue-facing side 61 of the distribution manifold 24. Further, the
method may include controlling the reduced pressure from the
reduced pressure source 38 according to the first pressure and the
second pressure. Further, in some embodiments, the method may
include determining a first time period for the first pressure to
respond to a change in the reduced pressure at the reduced pressure
source 38; determining a second time period for the second pressure
to respond to the change in reduced pressure at the reduced
pressure source 38; controlling the reduced pressure according to
the first time period if the first time period is less than the
second time period; and controlling the reduced pressure according
to the second time period if the second time period is less than
the first time period.
[0110] In some illustrative embodiments, a method for instilling
fluid at a tissue site may include positioning the distribution
manifold 24 adjacent a surface of the tissue site 25. The
distribution manifold 24 may include the tissue-facing side 61
facing the tissue site 25, and the outward-facing side 63 opposite
the tissue-facing side 61. Further, the method may include
positioning the adapter 22 adjacent the distribution manifold 24.
In such an embodiment, the adapter 22 may include at least one of
the ancillary ports 56, 58, and at least one port extension 37 as
shown in FIGS. 10-11. Further, the method may include inserting the
distal end 45 of the port extension 37 into the distribution
manifold 24, and delivering fluid to the surface of the tissue site
25 through the distal end 45 of the port extension 37.
[0111] In some embodiments, the method for instilling fluid may
include delivering reduced pressure to the outward-facing side 63
of the distribution manifold 24 through, for example, the primary
port 60 of the adapter 22. Further, in some embodiments, the method
for instilling fluid may include measuring a pressure between the
surface of the tissue site 25 and the tissue-facing side 61 of the
distribution manifold 24, and controlling the delivery of reduced
pressure according to the pressure.
[0112] In other embodiments, a method for instilling fluid at a
tissue site may include positioning the distribution manifold 24
adjacent a surface of the tissue site 25. The distribution manifold
24 may include a tissue-facing side 61 facing the tissue site 25,
and an outward-facing side 63 opposite the tissue-facing side 61.
Further, the method may include delivering fluid directly between
the surface of the tissue site 25 and the tissue-facing side 61 of
the distribution manifold 24.
[0113] While shown in a few illustrative embodiments, a person
having ordinary skill in the art will recognize that the systems,
apparatuses, and methods described herein are susceptible to
various changes and modifications. Moreover, descriptions of
various alternatives using terms such as "or" do not require mutual
exclusivity unless clearly required by the context, and the
indefinite articles "a" or "an" do not limit the subject to a
single instance unless clearly required by the context. Components
may be also be combined or eliminated in various configurations,
for example, for purposes of sale, manufacture, assembly, or use.
Further, components disclosed in connection with one embodiment may
be used in connection with another embodiment.
[0114] The appended claims set forth novel and inventive aspects of
the subject matter described above, but the claims may also
encompass additional subject matter not specifically recited in
detail. For example, certain features, elements, or aspects may be
omitted from the claims if not necessary to distinguish the novel
and inventive features from what is already known to a person
having ordinary skill in the art. Features, elements, and aspects
described herein may also be combined or replaced by alternative
features serving the same, equivalent, or similar purpose without
departing from the scope of this disclosure as defined by the
appended claims.
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