U.S. patent application number 13/660429 was filed with the patent office on 2013-10-03 for patient-orienting alternating pressure decubitus prevention support apparatus.
This patent application is currently assigned to TurnCare, Inc.. The applicant listed for this patent is TURNCARE, INC.. Invention is credited to Rafael P. Squitieri.
Application Number | 20130255699 13/660429 |
Document ID | / |
Family ID | 49233219 |
Filed Date | 2013-10-03 |
United States Patent
Application |
20130255699 |
Kind Code |
A1 |
Squitieri; Rafael P. |
October 3, 2013 |
PATIENT-ORIENTING ALTERNATING PRESSURE DECUBITUS PREVENTION SUPPORT
APPARATUS
Abstract
Described herein are systems and apparatuses for the prevention
and treatment of pressure ulcers. In particular, the ulcer
prevention systems and/or apparatuses disclosed herein prevent or
otherwise mitigate pressure ulcers by actively orienting a patient
over an anatomy-specific pressure-mitigating contact surface on
which the patient rests. A pressure-mitigating contact portion of
the contact surface includes a plurality of independently
pressurized chambers configured in a specific geometric pattern
that is designed to mitigate contact pressure between a support
surface (e.g., table or chair) and a specific anatomic region of a
patient's body when the specific anatomic region of the patient's
body is oriented over an epicenter of the geometric pattern. A
plurality of elevated side support portions are interconnected on
the base material and configured to actively orient the specific
anatomic region of the patient's body over the epicenter of the
geometric pattern.
Inventors: |
Squitieri; Rafael P.;
(Wilton, CT) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
TURNCARE, INC. |
Palo Alto |
CA |
US |
|
|
Assignee: |
TurnCare, Inc.
Palo Alto
CA
|
Family ID: |
49233219 |
Appl. No.: |
13/660429 |
Filed: |
October 25, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61618936 |
Apr 2, 2012 |
|
|
|
Current U.S.
Class: |
128/892 ;
128/889 |
Current CPC
Class: |
A61F 2013/15276
20130101; A61F 13/64 20130101; A61F 2013/51492 20130101; A61F
2013/15073 20130101; A61F 2013/15552 20130101; A61F 5/34 20130101;
A61F 13/51456 20130101; A61G 7/07 20130101; A61F 13/515 20130101;
A61G 2203/34 20130101; A61F 13/51474 20130101; A61F 13/15203
20130101; A61G 7/05769 20130101; A61F 13/505 20130101; A61F 13/84
20130101; A61G 7/05776 20130101; A61F 2013/15024 20130101; A61F
2013/8494 20130101; A61F 5/32 20130101; A61G 2205/60 20130101; A61F
2013/15154 20130101; A61F 13/512 20130101; A61F 13/513 20130101;
A61F 2013/5147 20130101 |
Class at
Publication: |
128/892 ;
128/889 |
International
Class: |
A61F 5/32 20060101
A61F005/32; A61F 5/34 20060101 A61F005/34 |
Claims
1. A contact pressure-mitigation support apparatus comprising: a
base material; a pressure-mitigating contact portion including a
plurality of independently pressurized relief chambers
interconnected on the base material, wherein the independently
pressurized relief chambers are configured in a geometric pattern
that mitigates contact pressure between a support surface and a
specific anatomic region of a patient's body when pressure in the
independently pressurized relief chambers is alternated and the
specific anatomic region of the patient's body is oriented over an
epicenter of the geometric pattern; and a plurality of elevated
side support portions interconnected on the base material, wherein
the elevated side support portions are configured to actively
orient the specific anatomic region of the patient's body over the
epicenter of the geometric pattern.
2. The contact pressure mitigation support apparatus of claim 1,
wherein the contact pressure between the support surface and the
specific anatomic region of the patient's body is mitigated by
alternating the pressure in one or more of the plurality of
independently pressurized relief chambers.
3. The contact pressure mitigation support apparatus of claim 1,
wherein the elevated side support portions are configured to
actively orient the specific anatomic region of the patient's body
over the epicenter of the geometric pattern when pressurized.
4. The contact pressure mitigation support apparatus of claim 1,
further comprising: one or more straps interconnected on the base
material, wherein the one or more straps are configured to secure
the pressure mitigation support apparatus to the support
surface.
5. The contact pressure mitigation support apparatus of claim 1,
further comprising: a position sensor interconnected on the base
material, the position sensor configured to confirm that the
specific anatomic region of the patient's body is over the
epicenter of the geometric pattern.
6. The contact pressure mitigation support apparatus of claim 5,
further comprising: a radio frequency (RF) transceiver
interconnected on the base material and configured to wirelessly
transmit the confirmation that the specific anatomic region of the
patient's body is over the epicenter of the geometric pattern.
7. The contact pressure mitigation support apparatus of claim 1,
wherein the pressure-mitigating contact portion is contoured to fit
the patient's surface topography in the sacral region.
8. The contact pressure mitigation support apparatus of claim 7,
wherein to fit the patient's surface topography the plurality of
independently pressurized relief chambers are shorter in height in
the center of the pressure-mitigating contact portion and taller in
height on the edges of the pressure-mitigating contact portion.
9. The contact pressure mitigation support apparatus of claim 1,
wherein a surface area of the pressure-mitigating contact portion
is designed to match the size of contact with the specific anatomic
region of the patient's body.
10. The contact pressure mitigation support apparatus of claim 1,
wherein a surface area of the pressure-mitigating contact portion
is less than the size of contact with the specific anatomic region
of the patient's body.
11. The contact pressure mitigation support apparatus of claim 10,
wherein the length and the width of the pressure-mitigating contact
portion are between fifteen and thirty inches.
12. The contact pressure mitigation support apparatus of claim 1,
wherein the plurality of elevated side support portions are
elevated two or more inches in vertical height above the average
surface height of the pressure-mitigating contact portion.
13. The contact pressure mitigation support apparatus of claim 1,
wherein the side support portions comprise independently
pressurized chambers.
14. The contact pressure mitigation support apparatus of claim 1,
wherein the side support portions include a recess to support the
patient's elbow.
15. The contact pressure mitigation support apparatus of claim 1,
wherein the independently pressurized relief chambers are
configured to be independently pressurized with a gas.
16. The contact pressure mitigation support apparatus of claim 1,
wherein the independently pressurized chambers are configured to be
independently pressurized with a liquid.
17. The contact pressure mitigation support apparatus of claim 1,
wherein the support surface comprises a mattress.
18. The contact pressure mitigation support apparatus of claim 1,
wherein the specific anatomic region of the patient's body
comprises the sacral region.
19. The contact pressure mitigation support apparatus of claim 1,
wherein to actively orient the specific anatomic region of the
patient's body over the epicenter of the geometric pattern, the
plurality of side support portions are configured to confine
lateral movement of the patient.
20. The contact pressure mitigation support apparatus of claim 1,
wherein to actively orient the specific anatomic region of the
patient's body over the epicenter of the geometric pattern, the
epicenter of the geometric pattern is overlaid on a V-shape in the
support surface.
21. The contact pressure mitigation support apparatus of claim 1,
wherein the anatomic region of the patient's body is segmented into
various sub-regions and the geometric pattern is configured such
that each of the independently pressurized chambers correspond to
one of the various sub-regions.
22. The contact pressure mitigation support apparatus of claim 1,
wherein the independently pressurized chambers fit to the
corresponding sub-region.
23. The contact pressure mitigation support apparatus of claim 1,
wherein the geometric pattern is symmetric and non-repeating in
nature.
24. The contact pressure mitigation support apparatus of claim 1,
further comprising: one or more channel tubes interconnected on the
base material, the channel tubes configured to deliver pressure to
the independently pressurized relief chambers.
25. The contact pressure mitigation support apparatus of claim 24,
wherein the one or more channel tubes follow seams between the
independently pressurized relief chambers.
26. The contact pressure mitigation support apparatus of claim 25,
wherein the seams are recessed between the independently
pressurized relief chambers when one or more of the independently
pressurized relief chambers is pressurized.
27. A partial body alternating contact pressure mattress overlay
device comprising: a plurality of independently pressurized
chambers configured in a geometric pattern that mitigates contact
pressure between a support surface and a specific anatomic region
of a patient's body when the specific anatomic region is oriented
over an epicenter of the geometric pattern; a plurality of elevated
side support portions interconnected on the base material, wherein
the elevated side support portions are configured to actively
orient the specific anatomic region over the epicenter of the
geometric pattern; and one or more straps configured to secure the
pressure mitigation support device to the support surface.
28. The partial body alternating contact pressure mattress overlay
device of claim 27, the device further comprising: a radio
frequency identification (RFID) detector configured to configured
to detect whether the specific anatomic region of the patient's
body is over the epicenter of the geometric pattern.
29. The partial body alternating contact pressure mattress overlay
device of claim 27, the device further comprising: one or more
pressure sensors configured to detect the real-time pressure of
each of the independently pressurized chambers.
30. An alternating contact pressure mattress comprising: a
mattress; a pressure-mitigating contact portion including a
plurality of independently pressurized relief chambers
interconnected on the mattress, wherein the independently
pressurized relief chambers are configured in a geometric pattern
that mitigates contact pressure between a support surface and a
specific anatomic region of a patient's body when the specific
anatomic region of the patient's body is oriented over an epicenter
of the geometric pattern; and a plurality of elevated side support
portions interconnected on the mattress, wherein the elevated side
support portions are configured to actively orient the specific
anatomic region of the patient's body over the epicenter of the
geometric pattern.
31. A contact pressure mitigation system comprising: a
pressure-mitigating support apparatus including a base material, a
pressure-mitigating contact portion including a plurality of
independently pressurized relief chambers interconnected on the
base material, wherein the independently pressurized relief
chambers are configured in a geometric pattern that mitigates
contact pressure between a support surface and a specific anatomic
region of a patient's body when the specific anatomic region of the
patient's body is oriented over an epicenter of the geometric
pattern, and a plurality of elevated side support portions
interconnected on the base material, wherein the elevated side
support portions are configured to actively orient the specific
anatomic region of the patient's body over the epicenter of the
geometric pattern; and a controller configured to regulate the
pressure of each of the independently pressurized relief
chambers.
32. A contact pressure-mitigation support apparatus comprising: a
base material; a pressure-mitigating contact portion including a
plurality of independently pressurized relief chambers
interconnected on the base material, wherein the independently
pressurized relief chambers are configured in a geometric pattern
that mitigates contact pressure between a support surface and a
specific anatomic region of a patient's body when pressure in the
independently pressurized relief chambers is alternated and the
specific anatomic region of the patient's body is oriented over an
epicenter of the geometric pattern; and a biocompatible adhesive
portion interconnected on the base material, wherein the
biocompatible adhesive portion is configured to actively orient the
specific anatomic region of the patient's body over the epicenter
of the geometric pattern.
33. The contact pressure-mitigation support apparatus of claim 32,
wherein the biocompatible adhesive portion extends along at least a
section of the perimeter of the contact pressure-mitigation support
apparatus.
34. The contact pressure-mitigation support apparatus of claim 32,
wherein the biocompatible adhesive portion extends along at least a
section of one or more of the plurality of the independently
pressurized relief chambers.
Description
CLAIM OF PRIORITY
[0001] This application claims priority to U.S. Provisional Patent
Application No. 61/618,936 entitled "PATIENT-ORIENTING ALTERNATING
PRESSURE DECUBITUS PREVENTION PILLOW," which was filed on Apr. 2,
2012, Attorney Docket No. 76970-8001.US00, the contents of which
are expressly incorporated by reference herein.
TECHNICAL FIELD
[0002] At least one embodiment of the present invention pertains to
medical prevention and treatment devices, and more particularly to
systems, methods, and/or apparatuses for the prevention and
treatment of decubitus ulcers.
BACKGROUND
[0003] Decubitus ulcers (commonly known as pressure ulcers) are a
frequent but often avoidable complication in many bed bound or
wheelchair bound individuals. These pressure skin ulcerations
typically occur as a result of steady pressure in one location on
the body such as, for example, the sacrum, most notably in patients
who are in bed for prolonged periods of time. Often times these
patients are older, malnourished and incontinent, all factors
predisposing patients to skin break down and ulceration. These
patients are often not ambulatory and sit for prolonged periods of
time in the same position either in bed or in a wheelchair. These
individuals often are unable to reposition themselves to alleviate
the pressure. Consequently, the pressure on the skin eventually
causes ischemia or lack of blood flow to the area and skin
breakdown results. Once the ulceration has formed and the skin
barrier is broken, infection may more readily enter the body and
cause infection and sepsis. The resulting infection often times
leads to further disability, and in some cases, death.
[0004] There are many support surfaces on the market for the
prevention of pressure ulcers. However, current support surfaces
lack the ability to control the spatial relationship between the
patient and the therapeutic surface (or contact surface) and thus
patients using these support surfaces may still end up with
pressure ulcer complications. Accordingly, the need exists for a
system that overcomes the above problems, as well as one that
provides additional benefits.
[0005] Overall, the examples herein of some prior or related
systems and their associated limitations are intended to be
illustrative and not exclusive. Other limitations of existing or
prior systems will become apparent to those of skill in the art
upon reading the following.
SUMMARY
[0006] Described herein are systems and apparatuses for the
prevention and treatment of pressure ulcers. In particular, the
ulcer prevention systems and/or apparatuses disclosed herein
prevent or otherwise mitigate pressure ulcers by actively orienting
a patient over an anatomy-specific pressure-mitigating contact
surface on which the patient rests.
[0007] In one embodiment, a contact pressure mitigation support
apparatus includes a pressure-mitigating contact portion and a
plurality of elevated side support portions. The
pressure-mitigating contact portion is interconnected on a base
material and includes a plurality of independently pressurized
chambers configured in a specific geometric pattern that is
designed to mitigate contact pressure between a support surface
(e.g., table or chair) and a specific anatomic region of a
patient's body when the specific anatomic region of the patient's
body is oriented over an epicenter of the geometric pattern. The
plurality of elevated side support portions is also interconnected
on the base material and configured to actively orient the specific
anatomic region of the patient's body over the epicenter of the
geometric pattern.
[0008] In an embodiment, the contact pressure between the support
surface and the specific anatomic region of the patient's body is
mitigated by alternating the pressure in one or more of the
plurality of independently pressurized relief chambers.
[0009] In an embodiment, the elevated side support portions are
configured to actively orient the specific anatomic region of the
patient's body over the epicenter of the geometric pattern when
pressurized.
[0010] In an embodiment, the contact pressure mitigation support
apparatus further includes one or more straps interconnected on the
base material, wherein the one or more straps are configured to
secure the pressure mitigation support apparatus to the support
surface.
[0011] In an embodiment, the contact pressure mitigation support
apparatus further includes a position sensor interconnected on the
base material. The position sensor is configured to confirm that
the specific anatomic region of the patient's body is oriented over
the epicenter of the geometric pattern.
[0012] In an embodiment, the contact pressure mitigation support
apparatus further includes a radio frequency (RF) transceiver
interconnected on the base material and configured to wirelessly
transmit the confirmation that the specific anatomic region of the
patient's body is over the epicenter of the geometric pattern
and/or receive instructions for individual chamber pressurization,
etc.
[0013] In an embodiment, the pressure-mitigating contact portion is
contoured to fit the patient's surface topography in the sacral
region.
[0014] In an embodiment, to fit the patient's surface topography,
the plurality of independently pressurized relief chambers are
shorter in height in the center of the pressure-mitigating contact
portion and taller in height on the edges of the
pressure-mitigating contact portion.
[0015] In an embodiment, a surface area of the pressure-mitigating
contact portion is designed to match the size of contact with the
specific anatomic region of the patient's body.
[0016] In an embodiment, a surface area of the pressure-mitigating
contact portion is designed to be less than the size of contact
with the specific anatomic region of the patient's body.
[0017] In an embodiment, the length and the width of the
pressure-mitigating contact portion are between fifteen and thirty
inches.
[0018] In an embodiment, the plurality of elevated side support
portions are elevated two or more inches in vertical height above
the average surface height of the pressure-mitigating contact
portion.
[0019] In an embodiment, the plurality of elevated side support
portions are elevated in vertical height above the average surface
height of the pressure-mitigating contact portion so as to create a
barrier to lateral movement.
[0020] In an embodiment, the side support portions comprise
independently pressurized chambers.
[0021] In an embodiment, the side support portions include a recess
to support the patient's elbow.
[0022] In an embodiment, the independently pressurized relief
chambers are configured to be independently pressurized with a
gas.
[0023] In an embodiment, the independently pressurized chambers are
configured to be independently pressurized with a liquid.
[0024] In an embodiment, the support surface comprises a
mattress.
[0025] In an embodiment, the specific anatomic region of the
patient's body comprises the sacral region.
[0026] In an embodiment, to actively orient the specific anatomic
region of the patient's body over the epicenter of the geometric
pattern, the plurality of side support portions are configured to
confine lateral movement of the patient.
[0027] In an embodiment, to actively orient the specific anatomic
region of the patient's body over the epicenter of the geometric
pattern, the epicenter of the geometric pattern is overlaid on a
V-shape in the support surface such that the epicenter of the
apparatus resides over the low point of the support surface that is
conformed into the V-shape upon which the apparatus rests.
[0028] In an embodiment, the anatomic region of the patient's body
is segmented into various sub-regions and the geometric pattern is
configured such that each of the independently pressurized chambers
correspond to one of the various sub-regions.
[0029] In an embodiment, the independently pressurized chambers fit
to the corresponding sub-region.
[0030] In an embodiment, the geometric pattern is symmetric and
non-repeating in nature.
[0031] In an embodiment, the contact pressure mitigation support
apparatus includes one or more channel tubes interconnected on the
base material, the channel tubes configured to deliver pressure to
the independently pressurized relief chambers.
[0032] In an embodiment, the contact pressure mitigation support
apparatus includes one or more channel tubes interconnected on the
base material, the channel tubes can be configured to deliver a gas
(i.e., air or oxygen.) from one or more openings in the channel
tubes. In this case, the channel tubes are not part of the pressure
relieving surface (i.e., low air loss surface) and the gas
delivered from the channel tubes is from a source independent from
the pressure controlled supply of gas to the pressurized relief
surfaces. That is, the gas delivered by the channel tubes is high
volume and under volume control regulation.
[0033] In an embodiment, the one or more channel tubes follow seams
between the independently pressurized relief chambers.
[0034] In an embodiment, the seams are recessed between the
independently pressurized relief chambers when one or more of the
independently pressurized relief chambers is pressurized.
[0035] In one embodiment, a partial body alternating contact
pressure mattress overlay device is disclosed. The partial body
alternating contact pressure mattress overlay device includes a
plurality of independently pressurized chambers, a plurality of
elevated side supports, and one or more straps. The plurality of
independently pressurized chambers are configured in a geometric
pattern that mitigates contact pressure between a support surface
and a specific anatomic region of a patient's body when the
specific anatomic region is oriented over an epicenter of the
geometric pattern. The plurality of elevated side support portions
are configured to actively orient the specific anatomic region over
the epicenter of the geometric pattern. The one or more straps are
configured to secure the pressure mitigation support device to the
support surface.
[0036] In an embodiment, the partial body alternating contact
pressure mattress overlay device further includes a radio frequency
identification (RFID) detector configured to configured to detect
whether the specific anatomic region of the patient's body is over
the epicenter of the geometric pattern.
[0037] In an embodiment, the partial body alternating contact
pressure mattress overlay device further includes one or more
pressure sensors configured to detect the real-time pressure of
each of the independently pressurized chambers.
[0038] In one embodiment, an alternating contact pressure mattress
includes a mattress, a pressure-mitigating contact portion and a
plurality of elevated side support portions. The
pressure-mitigating contact portion includes a plurality of
independently pressurized relief chambers interconnected on the
mattress, wherein the independently pressurized relief chambers are
configured in a geometric pattern that mitigates contact pressure
between a support surface and a specific anatomic region of a
patient's body when the specific anatomic region of the patient's
body is oriented over an epicenter of the geometric pattern. The
plurality of elevated side support portions are interconnected on
the mattress and configured to actively orient the specific
anatomic region of the patient's body over the epicenter of the
geometric pattern.
[0039] In one embodiment, a contact pressure mitigation system is
disclosed. The contact pressure mitigation system includes a
pressure-mitigating support apparatus and a controller. The
pressure-mitigating support apparatus includes a base material, a
pressure-mitigating contact portion including a plurality of
independently pressurized relief chambers interconnected on the
base material, wherein the independently pressurized relief
chambers are configured in a geometric pattern that mitigates
contact pressure between a support surface and a specific anatomic
region of a patient's body when the specific anatomic region of the
patient's body is oriented over an epicenter of the geometric
pattern, and a plurality of elevated side support portions
interconnected on the base material, wherein the elevated side
support portions are configured to actively orient the specific
anatomic region of the patient's body over the epicenter of the
geometric pattern. The controller is configured to regulate the
pressure of each of the independently pressurized relief
chambers.
[0040] In one embodiment, a contact pressure-mitigation support
apparatus includes a base material, a pressure-mitigating contact
portion, and a biocompatible adhesive portion. The
pressure-mitigating contact portion can include a plurality of
independently pressurized relief chambers interconnected on the
base material. The independently pressurized relief chambers can be
configured in a geometric pattern that mitigates contact pressure
between a support surface and a specific anatomic region of a
patient's body when pressure in the independently pressurized
relief chambers is alternated and the specific anatomic region of
the patient's body is oriented over an epicenter of the geometric
pattern. The biocompatible adhesive portion interconnected on the
base material is configured to actively orient the specific
anatomic region of the patient's body over the epicenter of the
geometric pattern.
[0041] In an embodiment, the biocompatible adhesive portion extends
along at least a section of the perimeter of the contact
pressure-mitigation support apparatus. The adhesive may be in
direct contact with the skin of the user.
[0042] In an embodiment, the biocompatible adhesive portion extends
along at least a section of one or more of the plurality of the
independently pressurized relief chambers.
BRIEF DESCRIPTION OF THE DRAWINGS
[0043] FIG. 1 depicts a side view of an example system for
orienting a patient over an anatomy-specific pressure-mitigating
contact surface on which the patient rests, according to an
embodiment.
[0044] FIG. 2 depicts an example pressure mitigation support
apparatus, according to an embodiment.
[0045] FIG. 3A and FIG. 3B depict top and side views, respectively,
of an example system for orienting a patient over an
anatomy-specific pressure-mitigating support surface on which a
patient rests, according to an embodiment.
[0046] FIG. 4A and FIG. 4B depict top and cross-sectional views,
respectively, of an example pressure mitigation support apparatus,
according to an embodiment.
[0047] FIG. 5 depicts an example pressure mitigation support
apparatus, according to an embodiment.
[0048] FIG. 6 depicts a flow chart illustrating an example process
for coordinated chamber inflation and deflation of a therapeutic
surface while the spatial relationship between the patient and the
therapeutic surface is controlled by the side-walls of the
therapeutic surface.
[0049] FIG. 7 depicts a diagrammatic representation of a machine in
the example form of a computer system within which a set of
instructions, for causing the machine to perform any one or more of
the methodologies discussed herein, may be executed.
DETAILED DESCRIPTION
[0050] Embodiments of the present disclosure include examples of
systems, methods, and apparatuses for the prevention and treatment
of pressure ulcers. In particular, the ulcer prevention systems
and/or apparatuses disclosed herein prevent or otherwise mitigate
pressure ulcers by actively orienting a patient over an
anatomy-specific pressure-mitigating contact surface on which the
patient rests. A pressure-mitigating contact portion of the contact
surface includes a plurality of independently pressurized chambers
configured in a specific geometric pattern that is designed to
mitigate contact pressure between a support surface (e.g., table or
chair) and a specific anatomic region of a patient's body when the
specific anatomic region of the patient's body is oriented over an
epicenter of the geometric pattern.
[0051] The following description and drawings are illustrative and
are not to be construed as limiting. Numerous specific details are
described to provide a thorough understanding of the disclosure.
However, in certain instances, well-known or conventional details
are not described in order to avoid obscuring the description.
References to one or an embodiment in the present disclosure can
be, but not necessarily are, references to the same embodiment;
and, such references mean at least one of the embodiments.
[0052] Reference in this specification to "one embodiment" or "an
embodiment" means that a particular feature, structure, or
characteristic described in connection with the embodiment is
included in at least one embodiment of the disclosure. The
appearances of the phrase "in one embodiment" in various places in
the specification are not necessarily all referring to the same
embodiment, nor are separate or alternative embodiments mutually
exclusive of other embodiments. Moreover, various features are
described which may be exhibited by some embodiments and not by
others. Similarly, various requirements are described which may be
requirements for some embodiments but not other embodiments.
[0053] The terms used in this specification generally have their
ordinary meanings in the art, within the context of the disclosure,
and in the specific context where each term is used. Certain terms
that are used to describe the disclosure are discussed below, or
elsewhere in the specification, to provide additional guidance to
the practitioner regarding the description of the disclosure. For
convenience, certain terms may be highlighted, for example using
italics and/or quotation marks. The use of highlighting has no
influence on the scope and meaning of a term; the scope and meaning
of a term is the same, in the same context, whether or not it is
highlighted. It will be appreciated that same thing can be said in
more than one way.
[0054] Consequently, alternative language and synonyms may be used
for any one or more of the terms discussed herein, nor is any
special significance to be placed upon whether or not a term is
elaborated or discussed herein. Synonyms for certain terms are
provided. A recital of one or more synonyms does not exclude the
use of other synonyms. The use of examples anywhere in this
specification including examples of any terms discussed herein is
illustrative only, and is not intended to further limit the scope
and meaning of the disclosure or of any exemplified term. Likewise,
the disclosure is not limited to various embodiments given in this
specification.
[0055] Without intent to further limit the scope of the disclosure,
examples of instruments, apparatus, methods and their related
results according to the embodiments of the present disclosure are
given below. Note that titles or subtitles may be used in the
examples for convenience of a reader, which in no way should limit
the scope of the disclosure. Unless otherwise defined, all
technical and scientific terms used herein have the same meaning as
commonly understood by one of ordinary skill in the art to which
this disclosure pertains. In the case of conflict, the present
document, including definitions, will control.
[0056] In one embodiment, the ulcer prevention systems and/or
apparatuses control pressure beneath specific anatomic locations of
the patient for specific durations in order to maximize blood flow
and reduce pressure over bony prominences in an effort to reduce
the incidence of pressure ulcers. Thus, the ulcer prevention
systems and/or apparatuses make it possible to increase and
decrease the pressure beneath a patient at specific locations for
set periods of time in order to maximize the potential therapeutic
benefits of the a therapeutic surface.
[0057] In one embodiment, the ulcer prevention systems and/or
apparatuses are specifically designed for mitigating pressure
and/or otherwise preventing pressure ulcers in the sacral area or
region of the human anatomy. This is unlike prior art surfaces or
overlays that are typically placed beneath the entire length of the
patient and do not function based on being uniquely oriented
beneath a specific location (or anatomic region) of the
patient.
[0058] In one embodiment, the geometric pattern is designed and/or
shaped according to general human anatomy and/or the individual
patient's specific anatomy. For example, if the ulcer prevention
systems and/or apparatuses are designed to mitigate contact
pressure between a support surface and the patient's sacral region
then the independently pressurized chambers are designed in
specific shapes to fit to the patient's pelvic bones, the gluteus
muscles, and/or the sacral arteries. In one embodiment, the
geometric pattern is symmetric and non-repeating in nature.
[0059] In one embodiment, the device's patient contact portion is
designed to actively orient the patient over the support surface
portion in a way that allows an apparatus to "know" for the first
time the location of the patient on that device. The apparatus is
designed to take advantage of this knowledge regarding the location
of the patient to more effectively mitigate and systematically
rotate the damaging pressure that leads to the formation of
pressure ulcers.
[0060] In one embodiment, the apparatuses described herein comprise
mattress overlay devices. The described overly devices differ from
the prior art mattress overlays that cover the full surface of the
bed. Further, the prior art mattress overlays typically have a
repeating pattern throughout and allow a patient to freely move
about over the entire surface of the bed. Conversely, the
apparatuses described herein are anatomy-specific and may only be
the size of the patient's anatomy that makes contact with the
apparatus. Accordingly, the disclosed systems, methods, and
apparatuses take advantage of the inherent knowledge of the
patient's location on the anatomy-specific pressure-mitigating
contact surface to systematically rotate and/or otherwise alternate
the damaging pressure that leads to the formation of pressure.
[0061] In one embodiment, the patient can be actively oriented over
an anatomy-specific pressure-mitigating contact surface by
controlling the spatial relationship between the patient and the
contact surface through the use of one or more side support
portions. In some embodiments, the side support portions may be
inflatable. In other embodiments, the side support portions are
fixed. In the former case, the side support portions may be
independently inflated with any appropriate gas or liquid. The
inflation of the side support portions is independent of the
pressurized relief chambers on the pressure-mitigating contact
portion. In some embodiments, the side support portions may be
inflated independent of each other in order to properly orient the
patient. This can be based on the actual pressure in a side support
portion versus an expected pressure in that side support portion as
determined by a control device. Alternatively or additionally, one
or more sensors can be built into the side support portions that
identify discrepancies in the ideal position of the patient on the
anatomy-specific pressure-mitigating contact surface and attempt to
adjust the patient accordingly (e.g., by independently adjusting
the pressure in the side support portions).
[0062] In one embodiment, the pressure in the side support portions
is fixed. In this case, the fixed side support portions may be
fixed using a liquid, a gas, and/or a solid. In the case where a
solid is used, Styrofoam, and/or any "cushion like" materials can
be utilized. The side support portions may be elevated in height
above the anatomy-specific pressure-mitigating contact surface in
order to prevent a patient from lateral movement (i.e., movement
along the x-axis). For example, the side support portions may be
elevated, when inflated, two to three inches in vertical height
above the average surface height of the pressure-mitigating contact
portion.
[0063] Further, to prevent movement along the y-axis the
anatomy-specific pressure-mitigating contact surface may be
designed such that a specific portion of the contact surface is
aligned over the surface of a V formed in a patient's hospital bed.
In one embodiment, the side support portions may be attached to the
sides of a pressure-mitigating contact portion. In one embodiment,
the side support portions may be configured with a recess
configured to accommodate a patient's elbow. The recess that
accommodates the patient's elbow results in a more comfortable
device that offloads pressure over the elbow of the patient.
[0064] In one embodiment, the design of the ulcer prevention
systems and/or apparatuses disclosed herein take into account
and/or control for various factors that influence functionality
and/or effectiveness of the ulcer prevention systems and/or
apparatuses. For example, the systems and/or apparatuses may take
time, space, patient weight, patient position, real-time interface
pressure, existing conditions (e.g., existing pressure ulcers),
and/or human anatomy into account in the prevention of pressure
ulcers.
[0065] In one embodiment, the systems and/or apparatuses may be
employed as a mattress overlay. For example, the overlay device or
apparatus could be deployed on any mattress or chair. Alternatively
or additionally, the systems and/or apparatuses may be incorporated
into the design of a mattress.
[0066] In one embodiment, the surface area of the pressure relief
surface is designed to match (or be less than) the size of the
patient's surface anatomy in the region of contact made between the
patient's anatomic region and the device. For example, the size of
the pressure relief surface may be the size of the patient's
surface anatomy in the region of contact made between the patient's
sacral region and the pressure mitigation support apparatus.
Further, the pressure relief surface may be contoured to fit the
surface topography of the patient's surface anatomy in the region
of contact made between the patient's sacral region and the
pressure mitigation support apparatus. The internal anatomy is
considered in the pattern--not the height--of the relief chamber
design.
[0067] In one embodiment, the pressure relief apparatus is designed
such that no portion of the independently pressurized relief
chambers of the surface area of the pressure relief surface in
contact with the patient is left uncovered by the patient. That is,
the independently pressurized relief chambers in contact with the
patient can be smaller than or equal to but not larger than the
area of contact with the patient. This feature improves performance
of the pressure relief apparatuses described herein. Conversely,
with prior art standard alternating pressure overlays, the pressure
relieving air cells are much larger than the contact area with the
patient and therefore the air cells are only partially covered by
of the patient. Thus, with prior art designs, the uncovered
portions of the pressure relieving air cells act as a reservoir
"sink" for the inflated air and minimize the lifting capabilities
of these surfaces that are needed to create areas of low pressure
fundamental to the optimal functioning of such a device.
[0068] In one embodiment, the independently pressurized relief
chambers of the pressure relief apparatus are unique in that the
entirety of the surface area of the independently pressurized
relief chambers are in contact with the patient such that no
portion of the independently pressurized relief chambers is left
uncovered by the user. Therefore, in this embodiment, the
individual independently pressurized relief chambers of the
pressure relief apparatus can be smaller than or equal to but not
larger than the area of contact with the patient. This feature can
improve performance of the pressure relief apparatus. In the case
of prior art standard alternating pressure overlays, the pressure
relieving air cells are much larger than the contact area with the
patient and therefore the air cells are only partially covered by
of the patient. Thus, with prior art designs, the uncovered
portions of the pressure relieving air cells act as a reservoir
"sink" for the inflated air and minimize the lifting capabilities
of these surfaces that are needed to create areas of low pressure
fundamental to the optimal functioning of such a device.
[0069] In one embodiment, the systems and/or apparatuses can be
employed as a mattress overlay and/or incorporated into the design
of a mattress itself. The overlay can be deployed on any mattress
or chair. The design of the pressure mitigation surface portion of
the overlay portion of the device takes into account multiple
factors. These factors include patient comfort, patient anatomy,
patient position (seated, flat, 30 degrees head up), and anatomic
locations with a propensity to develop pressure ulceration.
[0070] It is appreciated that the term "patient" as used herein can
include any individuals, users or persons that are in bed for
prolonged periods of time and thus susceptible to pressure
ulcers.
[0071] FIG. 1 depicts a side view of an example system 100 for
orienting a patient over an anatomy-specific pressure-mitigating
contact surface on which the patient rests, according to an
embodiment. The example system 100 includes a patient 110, a
support surface 115, a pressure mitigation support apparatus 120
and a control device 130. A more detailed example of a specific
pressure mitigation support apparatus (e.g., partial body
alternating contact pressure mattress overlay device) is shown and
discussed in greater detail with respect to FIG. 2.
[0072] In the example of FIG. 1, the pressure mitigation support
apparatus 120 is comprised of two elevated side support portions
125, a pressure-mitigating contact portion (shown in FIG. 2), and
straps 126. The pressure-mitigating contact portion includes a
plurality of independently pressurized relief chambers
interconnected on a base material. As described herein, the
independently pressurized relief chambers are configured in a
geometric pattern that mitigates contact pressure between the
support surface 115 and a specific anatomic region of a patient's
body when the specific anatomic region of the patient's body is
oriented over an epicenter of the geometric pattern. The support
surface 115 may be a hospital bed and/or mattress.
[0073] The elevated side support portions 125 are configured to
actively orient the specific anatomic region of the patient's body
over the epicenter of the geometric pattern. As shown, the specific
anatomic region of the patient's body is the sacral region.
However, it is appreciated that the specific anatomic region can be
any specific region of the patient's body that is susceptible to
pressure ulcers. The side support portions 125 are configured so as
to be ergonomically correct. For example, the side support portions
125 may be configured with a recess to accommodate the patient's
elbows in some embodiments resulting in a more comfortable
apparatus that off loads pressure over the elbow of the
patient.
[0074] The elevated side support portions 125 can be significantly
larger in size as compared to the size of the pressure relief
surface air cells. As a result, the elevated side support portions
125 create a barrier that keeps a patient from moving laterally or
sideways off of the anatomy-specific pressure-mitigating contact
surface. In one embodiment, the elevated side support portions 125
may be on average at least 2-3 inches taller in vertical height
after inflation as compared to the average height of the inflated
(or pressurized) pressure-mitigating contact portion. Because the
elevated side support portions 125 are larger and do not go
underneath the patient, but instead straddle the sides of the
patient, the elevated side support portions 125 act to hold and
position the patient on top of the anatomy-specific
pressure-mitigating contact surface.
[0075] The straps 126 are configured to secure the pressure
mitigation support apparatus to the support surface.
[0076] In one embodiment, inner side walls of the elevated side
support portions 125, on initial inflation of higher pressure, form
a firm surface at a steep angle of orientation with respect to the
patient on the pressure mitigation support apparatus 120. For
example, the inner side walls may be on a plane of 115 degrees plus
or minus 25 degrees from the plane of the pressure mitigation
support apparatus 120. These steep inner side walls create a
steeply angled side wall down which the patient, when positioned
inappropriately off to one side or another, will slide down toward
an epicenter of a geometric pattern formed on the pressure
mitigation support apparatus 120. Thus, inflation or pressurization
of the elevated side support portions 125 actively forces the
patient into a position ideal for the mitigation of pressure by
orienting the user in the correct position over the pressure
mitigation support apparatus 120. As a result, the patient's
anatomy will be correctly aligned with respect to the x-axis.
[0077] Once the initial inflation cycle has finished and the user
is properly positioned, the internal pressures of the elevated side
support portions 125 may decrease to a lower pressure to increase
comfort and prevent excessive force against the lateral aspect of
the patient. Ideally, a caregiver of the patient will be present
during the initial positioning of the patient over the pressure
mitigation support apparatus 120 to ensure proper positioning of
the patient by the elevated side support portions 125.
[0078] In one embodiment, the elevated side support portions 125
comprise steeply angled side walls. For example, the walls may be
angled such that the inner aspect of the elevated side support
portions 125 which contact the user on the lateral aspects of each
hip/thigh region simultaneously will form an obtuse angle of
between 90 to 145 degrees with respect to the plane of the pressure
mitigation support apparatus 120 (i.e., a pressure-mitigating
contact portion). The elevated side support portions 125 may be
connected by pressure channels (e.g., air channels).
[0079] In one embodiment, the elevated side support portions 125
are inflated and deflated in series together. Thus, like the
independently pressurized relief chambers, the air pressure in the
elevated side support portions 125 can be controlled by the control
device 130. Alternatively or additionally, each side support
portion of the elevated side support portions 125 can be controlled
by a unique control device and/or pump within the pump housing. The
pressures within the elevated side support portions 125 can be
determined based on pre-set parameters of the individual pump cycle
as determined on an individual patient specific basis (e.g.,
individual parameters based on the weight, existing pressure
ulcers, and/or position of the patient).
[0080] In one embodiment, there can be one or more air (or
pressure) channels (not shown) between the elevated side support
portions 125. In some cases, the air channels can be redundant.
Redundancy of air channels allows for even distribution of air (or
other pressure) between the elevated side support portions 125. For
example, one air channel may traverse the outside (or perimeter) of
the pressure mitigation support apparatus 120 to the top of the
apparatus while a second air channel traverse the outside of the
pressure mitigation support apparatus 120 a lower edge of the
apparatus. This configuration or arrangement creates a closed loop
circle around the pressure mitigation support apparatus 120 which
allows air to pass unobstructed from the pump into a first one of
the elevated side support portions 125 through the connecting air
channels and into a second one of the elevated side support
portions 125 without the weight of the patient blocking both
channels simultaneously as this is physically improbable with the
redundant configuration described herein.
[0081] In one embodiment, the pressure channels can flare out
slightly at the point of entry into the elevated side support
portions 125 so as to reduce the likelihood of kinking or otherwise
disturbing the inflation and/or pressurization of the pressure
channels.
[0082] In one embodiment, the pressure mitigation support apparatus
120 can have an additional elevated side support portion 125 that
is positioned between the legs of a patient along the lower aspect
of the pressure mitigation support apparatus 120 (not shown). This
additional elevated side support portion 125 can prevent a patient
from migration toward the foot of the bed in the y-axis.
[0083] In one embodiment, the elevated side support portions 125
function much like the side arms of a chair which has a seat
portion that is the same size as the "seat" of the user (e.g., a
chair that is too small for a user) These side arms allow only a
small lateral position shift of the user. As is the case with the
pressure mitigation support apparatus 120, this minimal lateral
motion is not great enough to allow the user to displace their
location off of the pressure mitigation support apparatus 120 to a
degree that will render the pressure relief characteristics less
effective.
[0084] The control system 130 is configured to regulate the
pressure of each of the independently pressurized relief chambers
via a pressure device 132 (e.g., air pump) and multi-channel tubing
135. For example, the independently pressurized relief chambers may
be controlled in a specific pattern to preserve blood flow and
reduce contact pressure when inflated (pressurized) and deflated
(depressurized) in a coordinated fashion that is controlled by the
control device 130. The multi-channel tubing 135 connects the
pressure mitigation support apparatus 120 with the air pump control
system 130. One or more connectors (not shown) may be used to make
these connections.
[0085] The control system 130 is configured to be programmed by a
patient, healthcare personnel, the patient, etc. In one embodiment,
the control system 130 can be programmed on a patient-specific
basis to manage and mitigate pressure on one or more existing
pressure ulcers that are currently present on a patient in a
specific anatomic location. As the geometry of the design is
specific to the patient's anatomy, the location of the pressure
ulcer on the patient can be entered into the computer controlled
pump and the ideal pressure time cycle optimized for healing the
ulcer in that specified anatomic location. For example, if a
patient has an ulcer in the typical location over the sacral bone
centrally, the cycle will preferentially drop the pressures in this
location and shorten the duration of pressure delivered to this
location in order to promote healing of the ulcer. Similarly, if
the ulceration is located over a specific ischial tuberosity, right
or left, the pressure can be preferentially relieved in this
location as the independently pressurized chambers are specifically
designed to fit the underlying anatomy and each region of concern
is able to be controlled specifically.
[0086] In one embodiment, the multi-channel tubing 135 comprises
multi-lumen tubing to control pressure at different chambers of the
plurality of independently pressurized chambers. Multi Lumen tubing
has multiple channels running through its profile. Multi Lumen
tubing has a variable Outer Diameter (OD), numerous custom Inner
Diameters (ID's), and various wall thicknesses. The tubing can be
in a number shapes; circular, oval, triangular, square, crescent,
etc.
[0087] In one embodiment, the control system 130 may comprise a
computer-controlled multi-channel air pump. The control system 130
may have a number of programmable settings and memory to remember
preferences. Further, in some embodiments, the control system 130
can control pressure beneath one or more specific anatomic
location(s) for specified durations in order to maximize blood flow
and reduce pressure. The specified durations can be programmable.
For example, the control system 130 can control the pressure in
each of the individual pressurized relief chambers of the pressure
mitigation support apparatus 120 such that the pressure in any
chamber changes or is modified after a specified period of time. In
this way, no part of the patient's body is left in contact with the
pressure mitigation support apparatus 120 for more than a period of
time. The period of time is programmable and may be based on
pre-programmed settings or customizable by the patient and/or a
health care professional.
[0088] Unlike some alternating pressure support surfaces, the
adjustable side walls 125 fix the relationship between the patient
and the pressure mitigation support apparatus 120. As a result the
pressure mitigation support apparatus 120 can reliably reduce
pressure in a concerted or consistent fashion for any specific
region of the patient's body in jeopardy of developing a pressure
ulcer because the patient is not free to move about over the
pressure mitigation support apparatus 120. Further, unlike products
with side support surfaces such as, for example, supports to keep
patients from falling off a large overlay support surface (i.e., a
mattress overlay) or the supports on a typical hospital bed, the
side supports 125 are customizable to the patient. For example, the
side walls 125 may be inflatable (pressurized) to fit to the
patient and keep the patient in the correct position (i.e., keep
the anatomic region of the patient's body oriented over an
epicenter of the geometric pattern). The pressure mitigation
support apparatus 120 presented herein is designed with a geometry
that requires the patient be properly held in position on the
surface in order for the design to effectively mitigate the
pressure beneath the patient and maximize blood flow to the tissues
at risk for ulceration.
[0089] In one embodiment, the side supports 125 will contact the
patient gently on the lateral aspect of both hips simultaneously in
order to actively orient the patient in the correct orientation on
the surface. The pressure mitigation support apparatus 120 can be
customized specifically to each individual patient in order to be
effective at pressure ulcer reduction. As will be appreciated, this
design is quite different from the support surfaces that utilize
side walls as a safety barrier to prevent patients from moving off
or falling off the surface support as the patient is free to move
about over these surfaces laterally between the sidewalls that are
typically as wide apart as a standard hospital bed. These current
products do not require the person to be in a precise location on
the surface as opposed to the patient-orienting surface described
here.
[0090] Being anatomy (or location) specific beneath the patient,
allows the apparatus to evenly distribute and rotate pressure from
one known location to another ensuring that no one area is under
the damaging effects of constant pressure for a prolonged period of
time that could lead to cell death from ischemia that leads to
tissue breakdown and pressure ulcer formation. Prior art support
surfaces which allow a patient to move freely over the support
surface cannot reliably rotate pressure from a specific area to
another and therefore are limited in their ability to prevent
pressure ulceration as compared to the systems and apparatuses
described herein.
[0091] Ideally, patients are positioned head up at 30 degrees in
bed to prevent aspiration pneumonia and to optimally offload the
patient's weight off of the sacrum and ischial tuberosities. This
is also the ideal bed position to ensure optimal function of the
apparatuses disclosed herein. However, in the event that a patient
is positioned flat in bed at 0 degrees as shown is the case of the
intubated, anesthetized and hypotensive ICU patient (and as shown
in FIG. 1), it will be necessary to confirm ideal patient position
over the device without the benefit of y-axis orientation control
achieved by placing the bed at 30 degrees head up (discussed in
greater detail with reference to FIG. 3).
[0092] In one embodiment X- and/or Y-axis orientation control can
be alternatively or additionally achieved through the use of a
radio frequency (RF) antenna device. For example, as an additional
measure to confirm patient location over the epicenter of our
device, an RF antenna can be incorporated into the
pressure-relieving surface. A thin flexible RFID tag/label may be
placed on the patient's sacrum using a biologic dressing material.
When in the proper orientation, the RFID tag will be detected by
the antennae and a signal light and sound will confirm the correct
position without needing to look beneath the patient and inspect
correct location by direct vision. The indicator signal will
display the correct direction in which to move the patient should
reorientation be required by the staff to ensure the immobile
patient is correctly positioned over the device to maximize
pressure redistribution and pressure rotation/relocation.
[0093] FIG. 2 depicts an example pressure mitigation support
apparatus 200, according to an embodiment. The pressure mitigation
support apparatus 200 includes side supports 225 and a
pressure-mitigating contact portion 222. The pressure-mitigating
contact portion 222 includes a plurality of independently
pressurized relief chambers 227. The independently pressurized
relief chambers 227 are configured in a specific geometric pattern
that mitigates contact pressure between a support surface and a
specific anatomic region of the patient's body when the specific
anatomic region of the patient's body is oriented over an epicenter
of the geometric pattern.
[0094] As shown in the example of FIG. 2, the epicenter may be a
central point of the pressure mitigation support apparatus, however
the epicenter need not be the central point of the apparatus. For
example, the epicenter may not be the central point if the pressure
mitigation support apparatus is not symmetric (or even if it is).
In some embodiments, the epicenter is a portion of the device that
is specifically designed to match up with an epicenter of the
specific anatomic region of the patient's body (e.g., the sacral
bone when the specific anatomic region is the sacral region). In
one or more embodiments, the epicenter will be marked so that a
patient and/or a caregiver (e.g., nurse) can easily identify the
epicenter of the apparatus.
[0095] In this example, the pressure mitigation support apparatus
200 includes a plurality of independently pressurized relief
chambers 227 that are configured in a specific "C-shaped" geometric
pattern that effectively mitigates and/or otherwise relieves
contact pressure between a support surface and a sacral region of a
patient's body when the pressure in the plurality of independently
pressured relief chambers 227 is alternated. The anatomy specific
"C-shaped" geometric design allows the geometric pattern to
properly align with the patient's anatomy resulting in superior
redistribution and relocation of pressure as compared to prior art
support surfaces.
[0096] The geometric pattern(s) described herein are specifically
designed to coincide with the internal anatomy of the sacral
region. For example, the geometric pattern of independently
pressurized relief chambers 227 conforms to a shape based on the
internal anatomy (muscle, bone, vessel) in order to maximize the
pressure-relieving properties of the apparatus. As a result,
pressure relief can be provided in specific areas of the sacral
region that are most prone to ulcer formation, namely over the bony
prominences--the sacrum and ischial tuberosities. The pattern of
the apparatus is therefore symmetric and non-repeating in nature.
This is different from prior art support surfaces that typically
employ repeating patterns over a large surface area of an entire
bed mattress. The functionality of these prior art surfaces do not
require knowledge of the location of a patient. That is, with prior
art surfaces there is no benefit for the patient being in one
location verses another. Accordingly, the prior art surfaces are
less effective and less accurate than the systems and/or
apparatuses disclosed herein.
[0097] In the example of FIG. 2, the geometric pattern illustrates
two lateral relief chambers forming "C" shapes facing each other
around a central circular relief chamber which is the size of the
sacral bone and positioned directly over the sacral bone. The
central circular relief chamber is designed to fit the area of skin
just at the top of the gluteal fold that overlies the sacral bony
prominence which is the area at greatest risk for pressure ulcer
formation.
[0098] In addition to the ability to directly relieving central
pressure, the device is designed to intermittently relieve pressure
just lateral to this central area. It is in this lateral region
that the blood supply to the central region is located. The major
blood supply via a named artery to the skin overlying the central
sacral area runs in a course from deep within the pelvis around the
lateral aspect of the sacral bone and travels to the skin overlying
the sacrum centrally. Lateral pressure directly beneath the C shape
regions which overlies the feeding arterial blood supply to the
central sacral region will lead to ulceration centrally over the
sacral bony prominence. The C shapes are located directly over the
superior gluteal arteries, the vascular blood supply to the skin
overlying the sacral bone.
[0099] A right and left superior gluteal artery run beneath the
right and left C shapes respectively. By deflating the relief
chamber that comprises the right C shape while the central air cell
and the left C shaped relief chamber remain inflated, the pressure
over the right superior gluteal artery is relieved and blood flow
is optimized through the right superior gluteal artery to skin
overlying the central area over the sacral bone. Similarly,
pressure can be relieved over the left superior gluteal artery by
performing a similar process with respect to the C-shaped air cell
over the left superior gluteal artery. Pressure is rotated from one
area to another as a result. The harmful effects of constant
pressure in one location for a prolonged period of time which can
lead to pressure ulcer formation are therefore avoided. These air
cells are intertwined so that any individual air cell may be
deflated and the other air cells that remain inflated will support
the area defined by the now un-inflated air cell such that an area
of low pressure is created in the area beneath the un-inflated air
cell.
[0100] In one embodiment, the specific pressure mitigation support
apparatus 200 may be a partial body alternating contact pressure
mattress overlay device as shown and discussed in greater detail
with respect to FIG. 3A and FIG. 3B. The pressure mitigation
support apparatus 200 may be the pressure mitigation support
apparatus 120 of FIG. 1; although alternative configurations are
possible.
[0101] In the example of FIG. 2, the side supports 225 control the
spatial relationship between the patient and the
pressure-mitigating contact portion 222. As discussed, the
geometric pattern of the pressure-mitigating contact portion 222 is
designed to reduce constant pressure on the patient in the same
place. In one embodiment, the side supports 225 may not be
inflatable but fixed. In one embodiment, side supports 225 are
disposed on each side of the support surface 200 to support
patients of variable hip width. Further, in some embodiments, the
side supports 225 may be decreasing in width from the outermost
wall to the innermost wall. It is appreciated that a geometric
pattern is shown for simplicity. The pressure-mitigating contact
portion 222 may include a variety of different patterns and/or
designs and sizes. Further, it is appreciated that the specific
pressure mitigation support apparatus 200 can be designed to reduce
pressure for specific regions or portions of a patient's body
and/or for a patient's entire body in some instances.
[0102] A control system such as, for example, the control system
130 of FIG. 1 individually controls the pressure in each of the
independently pressurized relief chambers. The pressure and length
of time each air cell is at a specific pressure will be determined
by an algorithm within the software program. In order to maximize
the efficacy of the system, the specific pressures and timing
cycles that will be utilized are patient-specific. The specific
program (time/pressure cycle) specified for an individual patient
may be determined by the specific patient's characteristics and/or
factors that are entered into the pump controller program. This
data is used to call for the optimal program for that patient.
Possible characteristics and/or factors can include, but are not
limited to, the patient's weight, the type of surface upon which
the apparatus or overlay rests (e.g., bed, stretcher, air mattress,
etc.), the patient position (flat in bed, bed at 30 degrees, bed at
45 degrees, bed at 90 degrees, sitting in chair, etc.), and/or the
location of preexisting pressure ulcers. These characteristics
and/or factors may be used to determine the pressure for the
independently pressurized relief chambers over a period of time
(e.g., the alternating pressure or the pressures needed to
effectively redistribute and relocate pressure within a specific
anatomic area).
[0103] In one embodiment, real-time (or near real-time) feedback
from the independently pressurized relief chambers will allow the
pump to adjust the pressure within each relief chamber towards the
desired set pressure for each air cell at each phase of the cycle.
Each relief chamber may be set to a specific pressure for a
specific length of time. The cycles of each chamber will be
coordinated with respect to all other chambers creating a
coordination of inflations and deflations of the entire group of
pressure relief chambers to maximize pressure redistribution and
relief within the apparatus. It is appreciated that there are a
finite number of cycle patterns that can achieve the desired result
based on the physical constraints dictated by the human anatomy,
the size of the sacral area, and the size that the air cells need
to be in order to be effective at pressure relief yet comfortable
and not prone to mal-align the long axis of the patient's spine if
they are too tall in height.
[0104] The physiologic pressure around 32 mmHg is the ideal
threshold below which pressure ulceration is less likely to occur.
Given this ideal pressure target of 32 mmHg, the apparatus includes
an ideal size of 2-3 inches for the pressure relief chambers in a
partial body overlay that will create the required wall tension of
the surface of these air cells to effectively redistribute high
pressure points without causing mal-alignment of the long axis of
the patient's spine. Additionally, in some embodiments, the
difference in height between adjacent pressure relief chambers is
not more that 1 inch in vertical height after inflation so as not
to create a surface that is uncomfortable to the patient.
[0105] The ideal internal pressures that are optimal in conjunction
with the identified ideal shapes of the pressure-relieving portion
of the device or apparatus, namely, given the shape and design of
the pressure relief surface (or pressure-mitigating contact
portion), using pressures within the central pressure relief
chamber that are on average 10 mmHg higher than the two lateral
pressure relief chambers will produce, include optimal
redistribution of interface pressure between the patient and the
device.
[0106] In one embodiment, the pressure mitigation support apparatus
200 may be constructed of various materials. For example, material
used in construction of the inflatable or patient contact portion
of the pressure mitigation support apparatus 200 may be determined
by the nature of the contact. If the pressure mitigation support
apparatus 200 is in direct contact with skin a soft, low sheer,
breathable fabric is ideal. This fabric will have an impervious
lining like, for example, polyurethane, etc. that is air tight and
used to create the air tight chambers. The materials may be
reusable and sterilizable. Conversely, if the pressure mitigation
support apparatus 200 is underneath a protective cover or bed
sheet, then the inflatable device can be made of an impervious
flexible material like polyurethane. This is ideal for a
multi-patient patient as it is easily washable and sterilized.
[0107] FIG. 3A and FIG. 3B depict top and side views, respectively,
of an example system 300 for orienting a patient over an
anatomy-specific pressure-mitigating support surface 320 on which a
patient (not shown) rests, according to an embodiment. In this
example, the anatomy-specific pressure-mitigating support surface
320 is used in conjunction with a typical hospital bed 315 (i.e.,
support surface) to control the spatial relationship between the
patient and the hospital bed. A control system 330 alternates
pressure in the chambers of the anatomy-specific pressure
mitigating support surface 320. The control system 330 may be the
control system 130 of FIG. 1, although alternative configurations
are possible.
[0108] More specifically, in the examples of FIG. 3A and FIG. 3B
the support device 320 is placed on or otherwise secured to a
standard hospital bed 315 that can maintain a 30 degree incline
position. The epicenter of the device 328 is aligned over the break
in the bed so that when a patient is seated on the device the side
supports 325 keep the person centered laterally (e.g., along the
x-axis or from side to side). In this configuration, the bed is in
a 30 degree "V" shape position that will keep the person from
moving toward the head or foot of the bed. This creates a centering
of the patient over the surface in both the east-west (between the
side walls) and north-south (between the head and leg elevations)
directions.
[0109] The epicenter 328 of the pressure relieving surface of the
apparatus is designed to contact the sacrum of the patient at the
top of the gluteal fold. This is the area of greatest incidence of
pressure ulceration in bed bound individuals. The apparatus is
specifically and uniquely shaped to protect this portion of the
patient anatomy as it represents the center of the pressure relief
surface around which the design is constructed. Conversely, as
previously discussed, the repeating patterns of prior art surface
designs at are not anatomy specific. The epicenter 328 is designed
to be placed and fixed on a support surface (e.g., hospital bed)
such that the epicenter 328 is located and/or otherwise oriented
over the break (or "V") in the bed.
[0110] In one embodiment, the epicenter 328 of the apparatus is
readily identified by its visual characteristics and marked by a
central 0.5 inch weld at the very center of the pattern. This
central half inch circle is visually aligned with the joint in the
bed frame that acts as the hinge point for flexing or breaking of
the bed into the 30 degree position.
[0111] In one example of installation on bed, the bed is first
inspected for the joint or pivot point. The overlay device or
apparatus is then placed on the bed so that the central point or
0.5 inch circular weld within the central 4.times.4 inch relief
chamber at the epicenter 328 of the overlay is directly over this
joint or hinge point in the bed. Lastly, the overlay is attached to
the bed frame at all four corner of the overlay using the one or
more straps 326. In one embodiment, the straps 326 may be 1 inch
Velcro straps; however any straps that can hold overlay to the bed
can be used. The overlay can be placed directly on the mattress and
covered by a fitted sheet or it can be attached to the bed over the
fitted sheet. A protective sleeve can be places over the overlay to
protect it and reduce cleaning requirements.
[0112] Once a patient is placed on the bed over the overlay device
or apparatus, the patient is in a location known to or actively
oriented by the device or apparatus and the control system can then
inflate (pressurize) and deflate (depressurize) the pressure relief
chambers of the relieving portion of the overlay in a preprogrammed
cycle for specific time/pressure values to optimize the
pressure-relieving capabilities of the system. The pressure and
timing cycles are also unique and specific to the design of the
system. The pressure and timing cycles may take into account the
weight of the patient, the position of the bed, and/or the type of
surface on which the overlay is resting, etc. The pressures used by
the control system may be calculated to be the minimal pressures
needed to achieve even redistribution of high pressure. Interface
pressure may be determined by the patient's weight and body
position. The greater the weight, the greater the downward pressure
of the patient on the overlay, and thus the greater the internal
pressure will need to be in order to lift the patient off the
underlying mattress in order to effect the redistribution of
pressure from high points to low points. This data may be
programmed into the controller by the healthcare team prior to use
and is specific for each patient.
[0113] In one embodiment, the surface area of the
pressure-mitigating contact portion 322 (e.g., or pressure relief
surface) of the pressure mitigation support apparatus 320 is
designed to match the size of the patient's anatomy in the region
of contact made between the patient's sacral region and the
apparatus. Thus, the size of the pressure-mitigating contact
portion 322 is the size of the patient's surface anatomy between
the patient's lower back to the mid thigh region (i.e., the sacral
region). The sacral region is typically a 20.times.20 square inch
area for the standard adult male of 75 Kg. In some embodiments, the
pressure mitigation support apparatus 320 may be size matched to
the patient. For example, the pressure mitigation support apparatus
320 may come in various sizes such as small, medium, large,
extra-large, etc. The sizes may thus range from a 12.times.12
square inch area to a 35.times.35 (or greater) square inch
area.
[0114] The pressure-mitigating contact portion 322 is also patient
size specific and designed to mirror the size of the patient. Thus,
the device or apparatus can have several sizes depending on the
patient's anatomy (e.g., small, medium, large, extra-large, etc.).
The device or apparatus is designed so that when sized
appropriately, the side supports 325 will gently contact the hips
of the patient on each side therefore aligning the patient over the
device such that the patient's anatomy is aligned with the
apparatus design which was patterned on the human anatomy.
[0115] In one embodiment, ideal patterns include designs that when
any given pressure relief chamber is deflated, the pressure relief
chambers that remain inflated are still effective in comfortably
supporting the weight of the patient such that a low pressure area
is created and maintained in the area of the deflated relief
chamber region by effectively holding up the patient in the regions
where the relief chambers remain inflated. This means that the
relief chambers must be neither too large nor too small in any
given area or region. In one embodiment, each of the three relief
chambers represent around 33% of the total surface area device
within a 20.times.20 square inch area of the sacral region.
[0116] With typical support surfaces (e.g., standard hospital bed)
a standard mattress or support surface is 36 inches wide.
Accordingly, patients using these devices still have ample room
between the patient and a side support (or bolster) which allows
them to move side to side (laterally). As a result with typical or
current support surfaces a patient is not held in a specific
location, and thus the typical support surface cannot be anatomy
specific.
[0117] For a device that is specifically designed to function
optimally when located beneath the patient's anatomy in a specific
location, then the ability to move around freely over the surface
would render that support surface ineffective as the patient and
the anatomy specific pattern would not be controlled by the
addition of the side bolsters. This differs from other full
mattress overlays or mattress support surfaces that are not sized
to matched in size to the contact surface of the patient's anatomy
but are much larger--i.e. standard bed size of 72 inches.times.36
inches. Most adult patients (ave 75 kg) unless extremely obese are
on average 20 inches wide.
[0118] In one embodiment, the pressure relief surface is also
contoured to fit the patient's surface topography in the sacral
region (i.e., larger in height to the lateral aspects of the relief
surface and shorter in height to the center of the pressure relief
surface). This contour creates a bowl shape from side to side in
the region of the pressure relief surface that compliments the
human topography of the sacral region. This is in distinction to
the consideration of the internal anatomy, namely blood vessels,
muscle and bony anatomy. This internal anatomy is considered in the
pattern (not height) of the air cell design which is distinct from
considerations of surface topography that dictate the vertical
height of the inflated air cells to accommodate variation in the
surface contours of the human anatomy. Inflation of the apparatus
can result in a bowl shape.
[0119] The bowl shape is designed to create an even distribution of
pressure when all the air cells of the pressure relief surface are
inflated. The result of the bowl shape is to maximally redistribute
pressure away from the central area where pressure ulceration is
most common--namely at the top of the gluteal fold. The pressure is
displaced to a more lateral location towards the hips. The 3-D
nature or differences in vertical height throughout the inflated
pressure relief surface is not utilized in prior art designs.
Further, the diameter or vertical height of the inflated pressure
relief chambers that make up the pressure relief surface are
specifically designed to be of a suitable height so as not to be so
large as to create mal-alignment of the long axis (spine) of the
patient but also not of a height that would be to small as to be
ineffective as a pressure relief surface. This vertical height is
roughly 2-3 inches on average.
[0120] FIG. 4A and FIG. 4B depict top and cross-sectional views,
respectively, of an example pressure mitigation support apparatus
400, according to an embodiment. The pressure mitigation support
apparatus 400 includes side supports 425 and a pressure-mitigating
contact portion 422. The pressure-mitigating contact portion 422
includes a plurality of independently pressurized relief chambers
427. The independently pressurized relief chambers 427 are
configured in a specific geometric pattern that effectively
mitigates contact pressure between a support surface and a specific
anatomic region of the patient's body when the specific anatomic
region of the patient's body is oriented over an epicenter of the
geometric pattern. The pressure mitigation support apparatus 400
may be, for example, the pressure mitigation support apparatus 120
of FIG. 1; although alternative configurations are possible.
[0121] As discussed above, the pressure mitigation support
apparatus 400 includes channel tubing 436. The channel tubing 436
is separate from the pressure relief surface portion of the device
but can be incorporated into the design of the device such that the
tubing will follow the seams or channels between the pressure
relief surfaces where adjacent independently pressurized relief
chambers meet. In one embodiment, the channel(s) are recessed into
the seams when the relief chambers 427 are pressurized and/or
otherwise inflated. Thus, once the relief chambers 427 are
pressurized and/or otherwise inflated, the channel tubing 436 does
not make physical contact with the patient. Additionally, the
channel tubing 436 does not contribute to the pressure mitigation
function of the device or apparatus. That is, the channel tubing
436 serves only to circulate pressure (e.g., air, liquid, etc.)
between the seams or recessed channels created by the relief
chambers 427.
[0122] In one embodiment, the pressure that exits the channels does
not originate from the relief chambers of the pressure relief
surfaces. For example, the pressure that exits from the
multi-channel tubing can originate from its own separate source.
The pressure or flow from the pressure channels is controlled by a
control system such as, for example, the control system 130 of FIG.
1. The control system can control the pressure (e.g., the air
supply) and not by the internal pressure of an air filled bladder
that comprises a portion of a pressure relieving surface as is the
case when a device is configured as a low air loss surface.
[0123] The channel tubing 436 is designed as a passive conduit and
not as chamber designed to inflate. The channel tubing 436 may be
designed not for low air loss as is the case with previously
described low air loss surfaces that leak a low amount of air from
the internal reservoir of the inflated support surface but the air
channels described here deliver do not leak a high volume of air or
gas dedicated only to this purpose and none other. The rate of air
flow from the channels is precisely controlled by a flow meter and
not dependent on internal pressures created within the device as is
the case with the low air low surfaces. The channels may have one
or more openings for the release of air. The control of the volume
of air delivered and not "lost" from the surface is under strict
control for the device as is not the case of low air loss surfaces.
(Volume not pressure control) In a low air loss setting, if the
openings are blocked by the weight of the patient, the air which is
at the set pressure of the pressure relieving air chamber will stop
flowing. This is different for the air channels described here
where the air is delivered by volume control. If the openings to
deliver the air are blocked by the weight of the patient, the
pressure of the delivered air will continue to rise until it is
greater than the external force blocking the openings of the air
channels. This variable pressure is not possible in a low air loss
configuration. Volume control delivery in a low air loss setting
would also control the pressure within the air chamber of the
support surface which is undesirable.
[0124] FIG. 5 depicts an example pressure mitigation support
apparatus 500, according to an embodiment. The pressure mitigation
support apparatus 500 includes a pressure-mitigating contact
portion 222 and one or more adhesive portions 545. The
pressure-mitigating contact portion 222 includes a plurality of
independently pressurized relief chambers 527. In this example, the
independently pressurized relief chambers 527 are configured in a
specific geometric "C-shape" pattern that mitigates contact
pressure between a support surface and a specific anatomic region
of the patient's body when the specific anatomic region of the
patient's body is oriented over an epicenter of the geometric
pattern. The one or more adhesive portions are interconnected on
the mitigation support apparatus 500. The adhesive portion may be
configured to actively orient the specific anatomic region of the
patient's body over the epicenter 528 of the geometric pattern
through one or more biocompatible adhesives. Although the pressure
mitigation support apparatus 500 is shown without side supports, it
is appreciated that such supports may be included in some
embodiments.
[0125] In the example, of FIG. 5, the one or more adhesive portions
545 are shown with cross shading. The one or more adhesive portions
545 may be biocompatible adhesive portions that extend along a
section of the perimeter of the contact pressure-mitigation support
apparatus. Alternatively or additionally, the one or more adhesive
portions 545 may extend along at least a section of one or more of
the plurality of the independently pressurized relief chambers such
as, for example, the "C-shaped" independently pressurized relief
chambers.
[0126] In one embodiment, the one or more adhesive portions 545 can
be adhered directly to the area of concern via a biocompatible
adhesive such as, for example, the adhesive material used in common
medical band-aids. In this case, the pressure mitigation support
apparatus 500 may essentially act as an inflatable band-aid "like"
device that could be in the form of the two "C-shapes" around a
central area of ulceration or a central area at risk of
ulceration.
[0127] FIG. 6 depicts a flow chart illustrating an example process
600 for coordinated chamber inflation and deflation of a
therapeutic surface to stimulate blood flow and reduce pressure
while a spatial relationship between a patient and a therapeutic
surface is controlled by side-walls of the therapeutic surface.
[0128] As discussed, the inflatable support surface is comprised of
the two side walls and a center portion with multiple separate air
bladders (or chambers) designed in a specific pattern to best
preserve blood flow and reduce pressure when inflated and deflated
in a coordinate fashion that is controlled by settings in the air
pump control device. Process 600 describes the coordinated chamber
inflation and deflation of a therapeutic surface according to one
embodiment.
[0129] In step 610, an air pump control system such as, for
example, air pump control system 130 of FIG. 1 determines an
initial pressure for each of a plurality of independently
pressurized chambers built into a therapeutic support surface. In
step 612, the air pump control system initializes one of more of
the settings. The initialization of the setting can include
selecting a program and/or one or more pressure timers. The
pressure timers can control when and if to change the pressure at
an individual chamber. In one embodiment, each chamber has its own
timer. However, in other embodiments, some chambers may share
timers. Further, any of the chamber timers can be configured to
work in concert. In one embodiment, one or more of the
initialization settings can be based on the patient (e.g., weight,
age, pre-programmed, etc.). In step 614, the air pump control
system checks to see if a timer has expired, and if so, in step
616, the air pump control system adjusts the pressure in the
associated chamber accordingly.
[0130] FIG. 7 shows a diagrammatic representation of a machine in
the example form of air pump control system 700 within which a set
of instructions, for causing the machine to perform any one or more
of the methodologies discussed herein, may be executed.
[0131] In alternative embodiments, the machine operates as a
standalone device or may be connected (e.g., networked) to other
machines. In a networked deployment, the machine may operate in the
capacity of a server or a client machine in a client-server network
environment, or as a peer machine in a peer-to-peer (or
distributed) network environment.
[0132] The machine may be a server computer, a client computer, a
personal computer (PC), a tablet PC, a set-top box (STB), a
personal digital assistant (PDA), a cellular telephone, a web
appliance, a network router, switch or bridge, or any machine
capable of executing a set of instructions (sequential or
otherwise) that specify actions to be taken by that machine.
[0133] While the machine-readable (storage) medium is shown in an
exemplary embodiment to be a single medium, the term
"machine-readable (storage) medium" should be taken to include a
single medium or multiple media (e.g., a centralized or distributed
database, and/or associated caches and servers) that store the one
or more sets of instructions. The term "machine-readable medium" or
"machine readable storage medium" shall also be taken to include
any medium that is capable of storing, encoding or carrying a set
of instructions for execution by the machine and that cause the
machine to perform any one or more of the methodologies of the
present invention.
[0134] In general, the routines executed to implement the
embodiments of the disclosure, may be implemented as part of an
operating system or a specific application, component, program,
object, module or sequence of instructions referred to as "computer
programs." The computer programs typically comprise one or more
instructions set at various times in various memory and storage
devices in a computer, and that, when read and executed by one or
more processors in a computer, cause the computer to perform
operations to execute elements involving the various aspects of the
disclosure.
[0135] Moreover, while embodiments have been described in the
context of fully functioning computers and computer systems, those
skilled in the art will appreciate that the various embodiments are
capable of being distributed as a program product in a variety of
forms, and that the disclosure applies equally regardless of the
particular type of machine or computer-readable media used to
actually effect the distribution.
[0136] Further examples of machine or computer-readable media
include but are not limited to recordable type media such as
volatile and non-volatile memory devices, floppy and other
removable disks, hard disk drives, optical disks (e.g., Compact
Disk Read-Only Memory (CD ROMS), Digital Versatile Disks, (DVDs),
etc.), among others, and transmission type media such as digital
and analog communication links.
[0137] Unless the context clearly requires otherwise, throughout
the description and the claims, the words "comprise," "comprising,"
and the like are to be construed in an inclusive sense, as opposed
to an exclusive or exhaustive sense; that is to say, in the sense
of "including, but not limited to." As used herein, the terms
"connected," "coupled," or any variant thereof, means any
connection or coupling, either direct or indirect, between two or
more elements; the coupling of connection between the elements can
be physical, logical or a combination thereof. Additionally, the
words "herein," "above," "below" and words of similar import, when
used in this application, shall refer to this application as a
whole and not to any particular portions of this application. Where
the context permits, words in the above Detailed Description using
the singular or plural number may also include the plural or
singular number respectively. The word "or," in reference to a list
of two or more items, covers all of the following interpretations
of the word: any of the items in the list, all of the items in the
list, and any combination of the items in the list.
[0138] The above-detailed description of embodiments of the
disclosure is not intended to be exhaustive or to limit the
teachings to the precise form disclosed above. While specific
embodiments of, and examples for, the disclosure are described
above for illustrative purposes, various equivalent modifications
are possible within the scope of the disclosure, as those skilled
in the relevant art will recognize. For example, while processes or
blocks are presented in a given order, alternative embodiments may
perform routines having steps, or employ systems having blocks, in
a different order, and some processes or blocks may be deleted,
moved, added, subdivided, combined and/or modified to provide
alternative or subcombinations. Each of these processes or blocks
may be implemented in a variety of different ways. Also, while
processes or blocks are at times shown as being performed in
series, these processes or blocks may instead be performed in
parallel, or may be performed at different times. Further, any
specific numbers noted herein are only examples; alternative
implementations may employ differing values or ranges.
[0139] The teachings of the disclosure provided herein can be
applied to other systems, not necessarily the system described
above. The elements and acts of the various embodiments described
above can be combined to provide further embodiments.
* * * * *