U.S. patent application number 12/758956 was filed with the patent office on 2010-08-05 for methods and apparatus for decubitus ulcer prevention and treatment.
This patent application is currently assigned to Angiosome, Inc.. Invention is credited to Robert M. Freund.
Application Number | 20100198122 12/758956 |
Document ID | / |
Family ID | 36097355 |
Filed Date | 2010-08-05 |
United States Patent
Application |
20100198122 |
Kind Code |
A1 |
Freund; Robert M. |
August 5, 2010 |
METHODS AND APPARATUS FOR DECUBITUS ULCER PREVENTION AND
TREATMENT
Abstract
An apparatus for treating or preventing decubitus ulcers
includes: a garment sized and shaped to be worn by a patient; a
first plurality of fluid channels and a second plurality of fluid
channels coupled to the garment and disposed adjacent to one
another, at least some of the first plurality of fluid channels
being independently inflatable and deflatable as compared with at
least some of the second plurality of fluid channels; and a fluid
control mechanism coupled to the first and second plurality of
fluid channels and operating to repeatably and sequentially inflate
and deflate the independently inflatable and deflatable fluid
channels from among the first and second plurality of fluid
channels such that there is less than a predetermined level of
pressure exerted on the patient's tissue under one or more of the
deflated channels.
Inventors: |
Freund; Robert M.; (Old
Westbury, NY) |
Correspondence
Address: |
GIBSON & DERNIER LLP
900 ROUTE 9 NORTH, SUITE 504
WOODBRIDGE
NJ
07095
US
|
Assignee: |
Angiosome, Inc.
Greenwich
CT
|
Family ID: |
36097355 |
Appl. No.: |
12/758956 |
Filed: |
April 13, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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10952349 |
Sep 27, 2004 |
|
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12758956 |
|
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Current U.S.
Class: |
601/151 |
Current CPC
Class: |
Y10S 2/03 20130101; A61F
13/143 20130101; A61F 13/085 20130101; A61F 13/069 20130101 |
Class at
Publication: |
601/151 |
International
Class: |
A61H 7/00 20060101
A61H007/00 |
Claims
1. An apparatus comprising: a garment sized and shaped to be worn
by a patient; a first plurality of fluid channels and a second
plurality of fluid channels coupled to the garment and disposed
adjacent to one another, at least some of the first plurality of
fluid channels being independently inflatable and deflatable as
compared with at least some of the second plurality of fluid
channels; and a fluid control mechanism coupled to the first and
second plurality of fluid channels and operating to repeatably and
sequentially inflate and deflate the independently inflatable and
deflatable fluid channels from among the first and second plurality
of fluid channels such that there is less than a predetermined
level of pressure exerted on the patient's tissue under one or more
of the deflated channels.
2. The apparatus of claim 1, wherein the predetermined level of
pressure is about 32 mm Hg.
3. The apparatus according to claim 1, wherein the fluid control
mechanism operates to sequentially: inflate the independently
inflatable and deflatable fluid channels from among the first
plurality of fluid channels while deflating the independently
inflatable and deflatable fluid channels from among the second
plurality of fluid channels; and deflate the independently
inflatable and deflatable fluid channels from among the first
plurality of fluid channels while inflating the independently
inflatable and deflatable fluid channels from among the second
plurality of fluid channels, such that there is less than about 32
mm Hg pressure exerted on the patient's tissue under one or more of
the deflated channels.
4. The apparatus according to claim 3, wherein: at least one of the
independently inflatable and deflatable fluid channels from among
the first plurality of fluid channels extends in a longitudinal
direction; and at least two of the independently inflatable and
deflatable fluid channels from among the second plurality of fluid
channels extend along either side of the at least one of the
independently inflatable and deflatable fluid channels from among
the first plurality of fluid channels.
5. The apparatus according to claim 4, wherein the fluid control
mechanism operates to sequentially and repeatably: inflate and
deflate the at least one of the independently inflatable and
deflatable fluid channels from among the first plurality of fluid
channels; and inflate and deflate the at least two of the
independently inflatable and deflatable fluid channels from among
the second plurality of fluid channels, such that there is less
than about 32 mm Hg pressure exerted on the patient's tissue under
the at least one of the independently inflatable and deflatable
fluid channels from among the first plurality of fluid channels,
while in a deflated state.
6. The apparatus according to claim 1, wherein the fluid control
mechanism comprises a pump releaseably connectable to the channels
of the garment.
7. An apparatus comprising: a body contact element sized and shaped
to engage a patient; a first plurality of fluid channels and a
second plurality of fluid channels coupled to the body contact
element and disposed adjacent to one another, at least some of the
first plurality of fluid channels being independently inflatable
and deflatable as compared with at least some of the second
plurality of fluid channels; and a fluid control mechanism coupled
to the first and second plurality of fluid channels and operating
to repeatably and sequentially inflate and deflate the
independently inflatable and deflatable fluid channels from among
the first and second plurality of fluid channels to provide a
rocking motion for moving the patient from one position to
another.
8. The apparatus of claim 7, wherein the fluid control mechanism
operates to inflate and deflate the independently inflatable and
deflatable fluid channels from among the first and second plurality
of fluid channels such that there is less than a predetermined
level of pressure exerted on the patient's tissue under one or more
of the deflated channels.
9. The apparatus of claim 8, wherein the predetermined level of
pressure is about 32 mm Hg.
10. An apparatus comprising: a mechanism configured to alleviate
pressure on a portion of a body by providing a varying pressure on
the portion, a position of the mechanism being based upon at least
one of a location of an angiosome and angiosome distribution in the
portion, wherein the mechanism includes at least one pressure
reliever and a plurality of channels positioned around the at least
one pressure reliever for protecting an area on the portion from
excess pressure, each channel: (i) configured to be offset from a
center of the pressure reliever, (ii) configured to extend radially
away from the center of the pressure reliever, and (iii) operable
to be inflated and/or deflated such that the pressure reliever
provides the varying pressure on the portion.
11. The apparatus according to claim 10, wherein the mechanism
includes a pump connected to the at least one channel, the pump
being configured to sequentially inflate and deflate the at least
one inflatable channel such that the provided pressure in the at
least one deflated channel on the portion is less than or equal to
about 32 mm Hg.
12. The apparatus according to claim 10, wherein the inflatable
channel is configured to be offset from the location of the
angiosome.
13. A method, comprising: providing a garment sized and shaped to
be worn by a patient; providing a first plurality of fluid channels
and a second plurality of fluid channels coupled to the garment and
disposed adjacent to one another, at least some of the first
plurality of fluid channels being independently inflatable and
deflatable as compared with at least some of the second plurality
of fluid channels; and repeatably and sequentially inflating and
deflating the independently inflatable and deflatable fluid
channels from among the first and second plurality of fluid
channels such that there is less than a predetermined level of
pressure exerted on the patient's tissue under one or more of the
deflated channels.
14. The method of claim 1, wherein the predetermined level of
pressure is about 32 mm Hg.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 10/952,349, pending and allowed, filed Sep.
27, 2004, the entire disclosure of which is hereby incorporated by
reference.
BACKGROUND
[0002] The present invention relates to a therapeutic
pressure-relieving device and method for preventing and treating
decubitus ulcers on a portion of a patient's body.
[0003] Decubitus ulcers (commonly referred to as "bedsores") may
form on parts or portions of a patient's body when in contact for a
prolonged period of time with an object such as, for example, a
bed, a wheelchair, or other type of furniture. The pressure exerted
on the skin covering or surrounding the bony prominences on the
portions of the patient's body that are in contact with a surface
on the furniture may result in the skin becoming inflamed, and may
obstruct or restrict the blood flow to the skin and/or the
underlying tissue, causing the skin and underlying tissue to become
ischemic, eventually resulting in the formation of decubitus
ulcers. Decubitus ulcers can form in any area of tissue covering a
bony prominence that is in contact with the surface of the bed or
sofa or other furniture upon which the patient is resting, e.g.,
parts of the spine, heels, elbows, and shoulders, shoulder blades,
as well as the sacral, trochanteric and ischial areas in the
coccyx, hips and buttocks.
[0004] Specifically, although arterial inflow can continue and
withstand pressure upwards of 170-mm Hg or greater, venous return
or blood flow from a region is restricted or obstructed with
pressures as low as 32-mm Hg on the skin and underlying tissue. The
restriction or obstruction of the venous return of blood from the
skin and underlying tissue may lead to the buildup of toxins and
waste products that may lead to the formation of decubitus ulcers.
Initially, pressure on the skin and tissue may lead to pink
coloration and/or mild inflammation, which may disappear within a
few hours of relieving pressure on the area. If pressure is not
relieved, superficial lesions may form on the skin, then turning
into ulcers which continue growing deeper until extending through
the bone to internal organs, eventually becoming fatal to the
patient.
[0005] A traditional means for preventing the formation of
decubitus ulcers is to physically turn the patient from side to
side at short intervals of time, thus alleviating the amount of
time a specific body part is subjected to straining pressures.
However, this method of prevention often proves ineffective since
the turning of the patient only relieves pressure from certain
regions of the body. Moreover, a patient will many times return to
a default position even after having been rotated. In addition,
since nurses or other aids must be present to physically rotate the
patient, this method is laborious, time-consuming and costly.
[0006] An alternative method for preventing the formation of
decubitus ulcers is the use of air mattresses. Since air mattresses
reduce the solidity of the contact surface, the mattresses relieve
some of the pressure on the patient's body. However, these devices
can be costly and not readily available to all patients.
Furthermore, the mattresses are not easily portable in case the
patient is moved to another unit or bed.
SUMMARY
[0007] This invention relates to a therapeutic device and method
for treating and preventing decubitus ulcers on parts or portions
of a patient's body by alleviating pressure on the tissue covering
and immediately surrounding the bony prominences in the body
portion and by alleviating pressure on the blood vessels in the
angiosomes in the body portion to allow blood flow to continue
throughout the body portion, including venous return, as well as
arterial inflow. The device may be configured to act upon a
particular body portion. The device may include inflatable channels
or pockets positioned within the device based on the distribution
of one or more angiosomes in the body portion, and pressure
relievers to protect the tissue covering and immediately
surrounding the bony prominences in the body portion. The channels
may be sequentially or periodically inflated and deflated to
alleviate pressure on the body portion while allowing blood flow
throughout the angiosomes.
[0008] In an example embodiment, the device may include a portable,
washable, removable, durable garment that provides pressure relief
from sacral, trochanteric and ischial pressure sores or decubitus
ulcers. The device may use sequential air channel technology to
relieve pressure and allow blood flow to and from the sacral,
trochanteric and ischial regions of the coccyx, hips and buttocks
based on the angiosome distribution or location of angiosomes in
the coccyx, hips and buttocks.
[0009] The garment may include rib-shaped or rib-patterned
inflatable cushions, pockets or channels radially oriented around a
position of an angiosome in each area. The channels are
sequentially inflated and deflated to vary and relieve pressure
around a center of the angiosome and maximize blood flow around the
angiosomes. Air, water or other fluids may be pumped into the
channels and removed from the channels with a bedside pump or motor
attached to ports that are connected to the channels in the
garment. The garment may be made with plastic or another material
that may be washable and collapsible for storage purposes. The
garment may also be made with a breathable fabric. For example, an
inner liner made out of cotton can be provided to line the interior
of the garment. The inner liner may be washable and replaceable or
disposable. The garment may also have one or more ports to
releasably connect the pump or motor to the garment.
[0010] The pump or motor can inflate and/or deflate the channels in
the garment through the ports on the garment. For example, the
garment may have two ports, with each half of the channels in the
garment being inflated and deflated by the pump through each of the
ports. Specifically, one set of channels may be deflated through
one port, while the channels in between the deflated channels are
being inflated through the other port.
[0011] In an example embodiment, an apparatus includes a portable
garment configured to be placed on a portion of a body to provide a
varying pressure on the body portion. The provided pressure varying
within a range sufficient for at least one of treating and
preventing a decubitus ulcer in the body portion.
[0012] In an example embodiment, an apparatus includes a mechanism
configured to alleviate pressure on a portion of a body. The
mechanism provides a varying pressure on the body portion. The
mechanism may include channels or pockets that are inflatable with
a fluid (e.g., air or water), or with a gel-like substance (e.g.,
silicon or another pliable material or substance). The pressure
provided by the sequential or periodic inflation and deflation of
the channels or pockets may vary continuously, e.g., by fluctuating
through a range of pressures, or it may vary periodically,
providing different levels of pressure at different time periods.
The mechanism is positioned based on, inter alia, the location or
distribution of one or more angiosomes in the body portion.
[0013] In an example embodiment, an apparatus comprises a device
including a plurality of inflatable channels configured to be
periodically or sequentially inflated and deflated to provide a
varying pressure on a portion of a body of a patient that varies
within a range sufficient for at least one of treating and
preventing a decubitus ulcer.
[0014] In an example embodiment, a garment for treating and
preventing decubitus ulcers around one or more of the coccygeal,
hip and buttocks areas of a patient's body includes one or more
cushions in the garment, and one or more adjustable bands removably
attaching the garment to the body. The cushions are positioned
radially away from one or more of the sacrum, ischial and
trochanter areas. The cushions are positioned in the garment as a
function of the location or distribution of the angiosomes in one
or more of the sacrum, ischial and trochanter areas.
[0015] In an example embodiment, an apparatus for treating and
preventing decubitus ulcers around at least one of a coccygeal,
buttocks and hip areas of a body includes a garment and a pump
releasably connectable to the garment. The garment includes a
plurality of inflatable channels and a plurality of pressure
relievers. The channels are configured to be alternately inflated
and deflated in order to provide a variety of pressures on a body
portion in or around the coccygeal, buttocks and hip areas of the
body. The channels and the pressure relievers are positioned in the
garment based on the locations of angiosomes or angiosome
distribution in one or more of the sacrum, ischial and trochanter
regions in the coccygeal, buttocks and hip areas. The pump is
configured to pump and remove air from the inflatable channels in
the garment.
[0016] In an example embodiment, a method for treating and
preventing decubitus ulcers on a portion of a body includes the
step of sequentially or periodically inflating and deflating
channels in a garment worn on the body portion. The maximum
pressure provided by the channels in the garment on the body
portion is sufficient to treat and/or prevent decubitus ulcers
treating or preventing a decubitus ulcer on the body portion.
[0017] In an example embodiment, a method for treating and
preventing decubitus ulcers on a portion of the body includes the
step of sequentially or periodically inflating and deflating air
channels in a garment worn on the body portion. The channels are
positioned in the garment as a function of the location of
angiosomes in the body portion.
[0018] In accordance with one or more further embodiments, methods
and apparatus provide for: a garment sized and shaped to be worn by
a patient; a first plurality of fluid channels and a second
plurality of fluid channels coupled to the garment and disposed
adjacent to one another, at least some of the first plurality of
fluid channels being independently inflatable and deflatable as
compared with at least some of the second plurality of fluid
channels; and a fluid control mechanism coupled to the first and
second plurality of fluid channels and operating to repeatably and
sequentially inflate and deflate the independently inflatable and
deflatable fluid channels from among the first and second plurality
of fluid channels such that there is less than a predetermined
level of pressure exerted on the patient's tissue under one or more
of the deflated channels.
[0019] The predetermined level of pressure may be about 32 mm
Hg.
[0020] The fluid control mechanism may operate to sequentially:
inflate the independently inflatable and deflatable fluid channels
from among the first plurality of fluid channels while deflating
the independently inflatable and deflatable fluid channels from
among the second plurality of fluid channels; and deflate the
independently inflatable and deflatable fluid channels from among
the first plurality of fluid channels while inflating the
independently inflatable and deflatable fluid channels from among
the second plurality of fluid channels.
[0021] According to one or more aspects, such inflation/deflation
is carried out such that there is less than about 32 mm Hg pressure
exerted on the patient's tissue under one or more of the deflated
channels. According to one or more additional or alternative
aspects, such inflation/deflation is carried out to provide a
rocking motion for moving the patient from one position to
another.
[0022] At least one of the independently inflatable and deflatable
fluid channels from among the first plurality of fluid channels may
extend in a longitudinal direction; and at least two of the
independently inflatable and deflatable fluid channels from among
the second plurality of fluid channels extend along either side of
the at least one of the independently inflatable and deflatable
fluid channels from among the first plurality of fluid channels. In
such case, the fluid control mechanism may operate to sequentially
and repeatably: inflate and deflate the at least one of the
independently inflatable and deflatable fluid channels from among
the first plurality of fluid channels; and inflate and deflate the
at least two of the independently inflatable and deflatable fluid
channels from among the second plurality of fluid channels, such
that there is less than about 32 mm Hg pressure exerted on the
patient's tissue under the at least one of the independently
inflatable and deflatable fluid channels from among the first
plurality of fluid channels, while in a deflated state.
BRIEF DESCRIPTION OF THE DRAWINGS
[0023] FIG. 1 illustrates a bone structure of a lower portion of a
human body.
[0024] FIG. 2 illustrates angiosome distribution and location, and
locations of blood vessels and tissues surrounding bony prominences
in the lower portion of a standing human body.
[0025] FIG. 3 illustrates angiosome distribution and location, and
locations of blood vessels and tissues surround bony prominences in
the lower portion of a seated human body.
[0026] FIG. 4 illustrates a perspective frontal view of an
embodiment of a device for preventing and treating decubitus ulcers
according to the present invention.
[0027] FIG. 5 illustrates a perspective rear view of the embodiment
of the device for preventing and treating decubitus ulcers of FIG.
4.
[0028] FIG. 6 illustrates a perspective rear view of a person in a
standing position wearing the embodiment of the device for
preventing and treating decubitus ulcers of FIG. 4.
[0029] FIG. 7 illustrates a perspective frontal view of a person in
a seated position wearing the embodiment of the device for
preventing and treating decubitus ulcers of FIG. 4.
[0030] FIG. 8 illustrates a partial view of a portion of an
embodiment of a device for preventing and treating decubitus ulcers
and a partial view of the underlying blood vessels and angiosomes,
according to the present invention.
[0031] FIG. 9 illustrates a partial view of a portion of an
embodiment of a device for preventing and treating decubitus ulcers
and a partial view of the underlying blood vessels and angiosomes,
according to the present invention.
[0032] FIG. 10 illustrates a frontal perspective view of an
embodiment of a device for preventing and treating decubitus ulcers
according to the present invention.
[0033] FIG. 11 illustrates a rear perspective view of an embodiment
of a device for preventing and treating decubitus ulcers according
to the present invention.
DETAILED DESCRIPTION
[0034] The present invention relates to a device and method for
preventing and treating decubitus ulcers. FIGS. 1 through 3
illustrate the underlying anatomy and conditions that lead to the
formation of decubitus ulcers. FIGS. 4 through 7 illustrate various
aspects of the device and method according to the present
invention.
[0035] As described above, a patient who is confined to a bed, a
wheelchair or other types of furniture, and cannot move or be moved
for prolonged periods of time, may be prone to decubitus ulcers
(also referred to as bed sores or pressure sores) in the parts of
their bodies having bony prominences that are subject to constant
pressure when the parts of their bodies are resting or being
constrained against a surface of the furniture. FIGS. 1 through 3
illustrates a basic bone structure, highlighting the bony
prominences in the middle portion 5 of a person's body 1 over which
pressure sores may form in tissue 3, 7 and 11 after a period of
continuous and static pressure to the overlying tissue, when a
patient is left or restrained to lie or sit in a bed or in a chair
for prolonged periods of time without movement. Ischial decubitus
ulcers or pressure sores may form in the tissue 3 covering the
ischium 4 in the buttocks 2. Trochanteric decubitus ulcers or
pressure sores may form in the tissue 7 covering the trochanters 6
(the broad flat bony prominence at the top of the femur 9) in the
hips 8. Sacral decubitus ulcers or pressure sores may form in the
tissue 11 covering the sacrum or sacral 12 in the area of the
coccyx 10.
[0036] Decubitus ulcers 3, 7 and 11, may be prevented and/or
treated with a device 20 that alleviates pressure on the tissue 3,
7 and 11 that is on and surrounds the bony prominences 4, 6 and 10
in a portion 5 of the body 1, while allowing blood to flow through
the angiosomes 18 and blood vessels 5 in the portion 5 of the body
1, while the patient is resting or is confined or constrained in a
particular position in or on a piece of furniture 13.
[0037] There are angiosomes 18 distributed throughout the middle
portion 5 of the body 1, and through other parts or portions of the
human body 1. An angiosome 18 is a three dimensional block of
tissue supplied by a single source artery. The distribution of
angiosomes 18 refers to a mapping of blood vessels 19 in a block of
tissue, or the tree-line pattern or arborization of blood vessels
in a certain area, e.g., in the body portion 5, or for the tissue
3, 7 and 11 on and surrounding the ischial or ischium 4,
trochanteric 6, and sacral or sacrum 12. If external pressure cuts
off the blood flow through one or more blood vessels 19 (e.g.,
venous return), then there may be a lack of nutrients and/or build
up of toxins or waste product in the 3 dimensional block of tissue
being serviced by those blood vessels 19 in a particular angiosome
18, which may lead to the formation of decubitus ulcers in the
tissue. Thus, if any device that purports to relieve pressure on a
part or portion 5 of the body 1 cuts off blood flow in an angiosome
18, the device may still affect the viability of the tissue being
supplied by the blood vessels 19 in the angiosome 18.
[0038] Thus, a device 20 that alleviates pressure on areas of
tissue 3, 7 and 11 while taking into account the location or
distribution of angiosomes 18 and blood vessels 19 in a portion of
a body 1, will be able to alleviate pressure, while allowing for
blood flow to continue in the portion 5 of the body 1. Since the
mapping of blood vessels 19 or distribution of angiosomes 18 tends
to be similar from person to person, it is possible to standardize
a design of a device 20 based on the location or distribution of
angiosomes 18 and blood vessels 19 in a portion 5 of the body 1,
and use the device 20 on more than one person.
[0039] The device 20 illustrated in FIGS. 4 through 9 is configured
to alleviate pressure on a middle portion 5 of the body 1 including
the buttocks 2, hips 8 and coccyx 10. The device 20 includes a
garment 25 and a pump 50 releasably attached or coupled or
connected thereto to pump air, water or other fluids or gel-like
substances and/or remove such fluids or substances from the garment
25 when the pump 50 is activated or actuated. The garment 25 is
portable and configured to fit around the waist 15, and may be worn
as a pair of shorts 26 on the body 1, alleviating pressure on and
around the trochanteric bony prominences 6 in the hips 8, the
ischial bony prominences 4 in the buttocks 2, and the sacral bony
prominences 12 in the coccyx 10, and allowing blood flow based on
the distribution of angiosomes 18 and the blood vessels 19 in the
angiosomes 18 in the body portion 5.
[0040] The garment 25 provides pressure varying in a range
sufficient for treating and/or preventing decubitus ulcers in the
body portion 5. Unlike products that provide higher pressures that
periodically cut off blood flow to simulate the pumping action of
arterial inflow to prevent and/or treat deep vein thrombosis, the
maximum pressure provided by the device 20 on the body portion 5 is
set below the pressure for preventing and/or treating deep vein
thrombosis.
[0041] The garment 25 includes sequential air technology to provide
varying pressure on the body portion 5, based on the location or
distribution of angiosomes 18 in the body portion 5 to allow for
maximal blood flow throughout the angiosomes 18 in the body portion
5, including through the blood vessels 19 therein. The sequential
air technology includes sequentially or periodically inflating and
deflating channels 30 in garment 25. The channels 30 may be
integrated or intertwined in a middle layer 22 or an outer layer 21
in the garment 25, and channels 30 may also refer to or include
pockets or cushions.
[0042] The channels 30 are inflatable with a fluid, e.g., air or
water, or with a gel-like substance, e.g., a silicon-based gel. The
channels 30 are positioned in the garment 25 based on the location
or distribution of angiosomes 18 in the body portion 5, and the
blood vessels 19 in the body portion 5. The channels 30 are
configured to be sequentially or periodically inflated and
deflated. The channels 30 may provide a fluctuating pressure by
continuously inflating or deflating, or the channels may provide an
otherwise varying pressure by remaining inflated and then deflated
for certain periods of time, e.g., 5 minutes in each phase. The
pressure applied by the inflated channels 30 on the body portion 5
and/or the pressure on the parts of the body portion 5 under the
deflated channels 30 may be configured or set not to exceed the
pressure that stops blood flow in the blood vessels, e.g., 32 mm
Hg. The time periods and patterns of inflation and/or deflation of
channels 30 may be configured to minimize the obstruction or
reduction of blood flow in the blood vessels 19, and blood supply
in the angiosomes 18 in the body portion 5.
[0043] Some of the channels 38 may be rib-shaped, parallel to one
another, and arranged in a rib-like pattern, as illustrated in FIG.
5. Additionally, at least some of the channels 30 may be configured
to be offset from the locations of angiosomes 18 or blood vessels
19 when the garment 25 is on the body portion 5. If the channels 30
were positioned in the garment 25 to cross blood vessels 19, then
inflation of the channels 30 may obstruct or restrict blood flow
through the blood vessels 19. In order to allow or promote maximal
blood flow through the blood vessels 19 and angiosomes 18, some of
the channels 30 may be positioned or configured to run adjacent to
or parallel to blood vessels 19 in the angiosomes 18, as
illustrated in FIGS. 8 and 9. The parallel placement of channels 30
helps to minimize any interruption or disturbance to the blood flow
in the body portion 5, when the channels 30 are being inflated
and/or deflated.
[0044] Some or all of the channels 30 may be spaced apart from one
another, as illustrated in FIG. 9. Some or all of the channels 30
may be interwoven or intertwined, as illustrated in FIG. 8. Even if
the channels are interwoven or intertwined, as illustrated in FIG.
8, there is no or little pressure (e.g., less than 32 mm Hg) on the
blood vessels 19 under the deflated channels 36, in part due to the
support provided by inflated channels 37, to allow blood flow,
including venous return as well as arterial inflow to continue
through the blood vessel 19.
[0045] The garment 25 may also include pressure relievers 44, and
42 to protect the underlying tissue from any excess pressure, such
as pressure from contact with a surface of the furniture 13.
Pressure relievers 44, 46 and 42 may include or be made with a
cushion or padding that alleviates some of the excess pressure on
the tissue 3, 7 or 11, when in contact with a surface of the
furniture 13. Alternatively, pressure relievers 44, 46 and 42 may
lack any cushion or padding, but be surrounded by padded support,
and the surrounding channels 30, so that the tissue thereunder does
not come into contact or encounters minimal pressure from the
garment 25 and from any surface on the furniture 13. The pressure
relievers 44, 46 and 42 may not be inflated or inflatable to reduce
or eliminate pressure placed on the underlying tissue.
[0046] Pressure reliever 44 is positioned in garment 25 to protect
at least part or all of the tissue 3 in the area of the ischium
bony prominence 4 in the buttocks 2. Pressure reliever 46 is
positioned in garment 25 to protect at least part or all of the
tissue 7 in the area of the trochanteric bony prominence 6 in the
hips 8. Pressure reliever 42 is positioned in garment 25 to protect
at least part of or all of the tissue 11 in the area of the sacral
bony prominence 12 in the coccyx 10. The garment 25 may include a
sacral ring 48 to surround or encircle pressure reliever 42. The
sacral ring 48 may provide extra support for the garment 25. For
example, if the sacral ring 48 is integrated with the outer layer
21, the sacral ring 48 may maintain the integrity of the garment 10
around the sacrum 12. The sacral ring 48 may be made of a rigid
material or a more flexible material, such as, e.g., plastic.
Alternatively, the garment 25 may have no sacral pressure reliever
42, but the tissue in the sacral area 11 may be protected from
excess pressure by the sacral ring 48 alone, for example, if it is
of sufficient thickness to protect tissue 11 from direct contact
with a surface of furniture 13.
[0047] Some of the channels 30 in the garment 25 may include one or
more channels 35 configured around the pressure relievers 44, 46
and 42. The channels 35 may be configured or positioned to be
offset from the center of the tissue on and surrounding a bony
prominence, e.g., centers 45, 47 and 43 of the areas of tissue 3, 7
and 11, covering the ischium, trochanteric and sacral bony
prominences 4, 6 and 12, in the region of the buttocks 2, hips 8
and coccyx 10, respectively, also referred to as the ischial,
trochanteric and sacral areas of the body portion 5. The channels
35 may be referred to as additional channels, and may be positioned
to extend radially from the centers 45, 47 and 43 when the garment
25 is on the body portion 5. The channels 35 arranged radially
around the pressure relievers 44, 46 and 42, and around the tissue
centers 45, 47 and 43, may extend radially through the part of
tissue 3, 7 and 11 that surround the centers 45, 47 and 43 (which
may also be referred to as pressure centers). The remainder of the
channels 30 may be positioned in rib-like patterns outside of the
pressure relievers 44, 46 and 42, and the additional channels 35
positioned around the pressure relievers 44, 46 and 42.
[0048] The device 20 also includes a pump 50 releasably connectable
to the garment 25 via one or more valves or ports on garment 25.
The pump 50 may be small and lightweight, to be portable, and may
be configured to be releasably attachable to one or more pieces of
furniture (including a chair 13, or for example, the intravenous
pole), or directly to the person using the garment 25, e.g., as on
a belt around the waist 15.
[0049] As illustrated in FIGS. 4 through 6, pump 50 is releasably
connectable to ports 27 and 28 on garment 25. The pump 50 is
configured to periodically or sequentially inflate and deflate one
or more of the channels 30 in the garment 25 through valves or
ports 27 and 28 on garment 25, e.g., by pumping and/or removing
air, water or other fluids or gel-like substances into and/or out
of the channels 30 through ports 27 and 28. The pump 50 may be
configured to be able to regulate the amount of fluids or substance
being pumped or removed from channels 30. The pump 50 may also be
configured to time the periods for each of the inflation and
deflation cycles. The pump 50 may be configured to inflate and
deflate all of the channels at the same time. Alternatively, the
pump 50 may be configured to inflate one subset of channels 30
through port 27 while deflating another subset of channels 30
through port 28. As illustrated in FIGS. 8 and 9 with arrows
indicating directions of fluid movement, one subset of channels 37
may be inflated through port 27 while another subset of channels
36, alternating between channels 37, are being deflated through
port 28.
[0050] Alternatively, the first subset of channels 30 may be
configured to be one side of the garment 25, and the second subset
of channels 30 may be configured to be on another side of the
garment 25. The sequential or periodic inflation and/or deflation
of the first and second subsets of channels 30 under this
configuration provides a rocking motion, and may be implemented to
periodically move the patient from one position to another. The
pump 50 may be supplied with additional ports (not shown), so that
the pump 50 may be configured to act on one set of channels 30 at a
time, for example, leaving a third subset of channels entirely
deflated if it is on a portion of the body not in contact with a
piece of furniture 13. In any case, alternately inflating and
deflating different portions of garment 25 or different subsets of
channels 30 according to different patterns will prevent pressure
from inflated channels remaining on any specific location of the
body portion 5 for an extended amount of time.
[0051] The garment 25 itself may be made with a durable washable
material, e.g., plastic. The garment 25 may be configured with
layers, as illustrated in FIG. 4. The channels 30 may be integrated
into a middle layer 22 of garment 25. Outer layer 21 may provide a
protective plastic covering over the channels 30 and the remainder
of the garment 25. The outer layer 21 may have holes or pores 29 to
allow air to pass through to and from the middle layer 22, the
inner layer 23 and the body portion 5. Outer layer 21 may be
detachable from the rest of the garment 25, to be washed or rinsed
off, or replaced.
[0052] The inner layer 23 may include a liner or lining 24 that is
made with a breathable or softer or hypoallergenic fabric or other
material, e.g., cotton, nylon, polyester, rayon, or lycra, or a
combination or blend of any two or more of the foregoing materials.
The lining 24 may be releasably attachable to the inner layer 23 of
the garment 25. The lining 24 may cover all or part of the inner
layer 23 of the garment 25. The lining may be removable to be
washable or disposable, and in any case, replaceable.
[0053] The garment 25 may be releasably attachable to the body
portion 5 via one or more straps 60 on a front side 70 of the
garment 25, as illustrated in FIG. 4. The straps 60 may be elastic
bands 61 or otherwise adjustable, as adjustable band 62. The straps
60 may be made with a material including cotton, to increase the
comfortability of the device 20. The straps 60 may make it easier
for the garment 25 to be placed on or removed from the body portion
5.
[0054] The straps 60 may be spaced apart from one another in order
to permit the frontal area of the body portion 5 to remain exposed
for further examination and follow up by a doctor, nurse or other
care giver. The straps also provide a way of attaching the garment
25 to the body portion 5, without unnecessarily covering the
frontal area of the body portion 5. The straps 60 may allow the
person wearing the garment 25 to be more comfortable and cooler,
then if the frontal area of the body portion 5 were fully covered
as well.
[0055] The straps 60 may be permanently attached at a distal end 64
to a first side 72 of the garment 25, and releasably attached at a
proximal end 65 to an opposite side 73 of the front side 70 of the
garment 25. The straps 60 may be releasably attachable with velcro
63 on sides 73, or with buttons, snaps, zippers and other modes of
releasably attaching or fastening the straps 60 to the sides 73 of
the garment 25.
[0056] The device 20 illustrated in FIGS. 4 through 9 is configured
for body portion 5, including the buttocks 2, hips 8, and coccyx
10. As illustrated in FIG. 10, the device 20 may extend further
down the legs and further along the arms, with channels 30 and
pressure relievers 41 and 49 for the elbows and calves. As
illustrated in FIG. 11, device 20 may include a garment 80
configured to fit on an upper body portion, with shoulder blade
pressure relievers 84, and with elbow pressure relievers 82. The
device 20 may be configured with pressure relievers in a variety of
locations, and a variety of patterns for the distribution of
channels 30, depending on the position of the body 1, the type of
furniture 13, and other conditions.
[0057] In the preceding specification, the present invention has
been described with reference to specific exemplary embodiments
thereof. It will, however, be evident that various modifications
and changes may be made thereunto without departing from the
broader spirit and scope of the present invention as set forth in
the claims that follow. The specification and drawings are
accordingly to be regarded in an illustrative rather than
restrictive sense.
* * * * *