U.S. patent application number 12/294887 was filed with the patent office on 2010-11-04 for lipowear.
Invention is credited to Terry Delonas.
Application Number | 20100275346 12/294887 |
Document ID | / |
Family ID | 43029261 |
Filed Date | 2010-11-04 |
United States Patent
Application |
20100275346 |
Kind Code |
A1 |
Delonas; Terry |
November 4, 2010 |
Lipowear
Abstract
Contemplated padded undergarments are form-fitted and have a
higher than normal ratio of waist circumference to leg
circumference and include a padded area that covers substantially
the entire contact area of buttocks and legs with a chair when a
person wearing such undergarment is sitting on the chair. Such
undergarments are particularly advantageous to provide symptomatic
relief for a person diagnosed with HIV infection, a neoplastic
disease, chronic diabetes, and/or advanced age, which is typically
accompanied by lipoatrophy, lipodystrophy, and/or sarcopenia.
Inventors: |
Delonas; Terry; (Irvine,
CA) |
Correspondence
Address: |
FISH & ASSOCIATES, PC;ROBERT D. FISH
2603 Main Street, Suite 1000
Irvine
CA
92614-6232
US
|
Family ID: |
43029261 |
Appl. No.: |
12/294887 |
Filed: |
December 13, 2006 |
PCT Filed: |
December 13, 2006 |
PCT NO: |
PCT/US06/47691 |
371 Date: |
June 30, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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11277818 |
Mar 29, 2006 |
|
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12294887 |
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Current U.S.
Class: |
2/400 ;
2/267 |
Current CPC
Class: |
A41D 13/0537 20130101;
A41D 13/1254 20130101; A41B 9/001 20130101 |
Class at
Publication: |
2/400 ;
2/267 |
International
Class: |
A41B 9/00 20060101
A41B009/00; A41D 27/00 20060101 A41D027/00 |
Claims
1. An item of manufacture, comprising: a form-fitted undergarment
comprising a waist portion having a waist circumference and a leg
portion having a leg circumference, wherein a ratio of the waist
circumference to the leg circumference is higher than a normal
ratio; and a padded area that is configured to provide protection
extending from an upper area of the waist portion to a lower area
of the leg portion such that buttocks and legs of a person
contacting a seat while sitting on a chair are substantially
completely covered by the padded area.
2. The item of claim 1 wherein at least one of the waist portion
and the leg portion comprises an elastic material.
3. The item of claim 1 wherein the ratio is characteristic of a
person diagnosed with at least one of lipoatrophy, lipodystrophy,
and sarcopenia.
4. The item of claim 1 wherein the ratio is further characteristic
of the person diagnosed with at least one of an HIV infection, a
neoplastic disease, advanced age, and chronic diabetes.
5. The item of claim 1 wherein the ratio is at least 1.9.
6. The item of claim 1 wherein the ratio is at least 2.0.
7. The item of claim 1 wherein the padded area extends to a
substantially topmost end of the waist portion.
8. The item of claim 1 wherein the padded area extends to a
substantially lowermost end of the leg portion.
9. The item of claim 1 wherein the padded area is configured as an
independent right and left area, and wherein each area includes a
removable pad.
10. The item of claim 1 wherein the padded area comprises a
plurality of vent openings and is further contoured to have a
thicker than average thickness in a buttock area.
11. The item of claim 10 wherein the padded area is further
contoured to have a thinner than average thickness in a peripheral
area of the padded area.
12. A method of providing symptomatic relief for a person suffering
from at least one of HIV infection, chronic diabetes, neoplastic
disease, lipoatrophy, lipodystrophy, and sarcopenia comprising a
step of providing the form-fitted undergarment according to claim
1.
13. The method of claim 12 wherein the ratio is at least 1.9.
14. The method of claim 12 wherein the ratio is at least 2.0.
15. The method of claim 12 wherein the padded area is configured as
an independent right and left area, and wherein each area includes
a removable pad.
16. The method of claim 12 wherein the padded area comprises a
plurality of vent openings and is further contoured to have a
thicker than average thickness in a buttock area.
17. A method of providing improved sitting comfort to a person,
comprising: providing a form-fitted undergarment comprising a waist
portion and a leg portion, and further comprising a padded area;
wherein the padded area is configured to provide protection
extending from an upper area of the waist portion to a lower area
of the leg portion such that buttocks and legs of a person
contacting a seat while sitting on a chair are substantially
completely covered by the padded area; and informing the person
that the undergarment provides reduction in at least one of pain,
numbness, local hemostasis, and deep vein thrombosis when the
garment is worn during a period of sitting over at least three
hours.
18. The method of claim 17 wherein the padded area has an average
thickness of between 0.5 inch to 1 inch.
19. The method of claim 17 wherein the padded area is contoured to
have a thinner than average thickness in a peripheral area of the
padded area.
20. The method of claim 17 wherein the padded area is configured as
an independent right and left area, and wherein each area includes
a removable pad.
Description
[0001] This application claims the benefit of our copending U.S.
patent application with the Ser. No. 11/277,818, which was filed
Mar. 29, 2006.
FIELD OF THE INVENTION
[0002] The field of the invention is functional clothing,
especially as it relates to undergarments with a padding that is
configured to alleviate symptomatic discomfort associated with
various conditions, and particularly lipodystrophy, lipoatrophy,
and/or sarcopenia.
BACKGROUND OF THE INVENTION
[0003] Various conditions and diseases are associated with loss or
maldistribution of body mass, and especially fat and muscle tissue.
For example, long-term treatment of patients infected with the HIV
virus is often accompanied by lipodystrophy, lipoatrophy, and/or
sarcopenia. Similar problems are also encountered by patients
undergoing chemotherapy for treatment of cancer, and/or long-term
diabetes patients.
[0004] While pain due to lipodystrophy, lipoatrophy, peripheral
neuropathy, and/or sarcopenia can be treated with analgesics, drug
therapy is often not desirable due to high costs and/or side
effects of the drugs. Most significantly, loss of body mass, and
especially loss of fatty tissue in the buttocks and legs typically
lead to tenderness, and more typically severe pain in such patients
which transforms routine daily activities (e.g., sitting on a
chair, lacing shoes) into a challenge. Thus, the quality of life is
significantly reduced and even prevents at least some of these
patients from participation in ordinary daily life. Remarkably,
there are numerous garments known in the art that increase sitting
comfort of a person on bicycle seat or provide cushioning for
sports activities, however, none of them has been shown to
substantially alleviate personal discomfort for patients having
lipodystrophy, lipoatrophy, peripheral neuropathy, and/or
sarcopenia.
[0005] For example, U.S. Pat. No. 4,984,304 describes an
undergarment with a pad that shapes and uplifts the lower buttocks
for cosmetic reasons. Clearly, such undergarment is not suitable
for patients with lipodystrophy, lipoatrophy, peripheral
neuropathy, and/or sarcopenia and further fails to significantly
cushion affected areas. In another example, as shown in U.S. Pat.
No. 4,969,216, an undergarment has a large unitary cushion that is
configured to cover the buttocks area. While at least some
protection is provided to the pericoxxigeal area, the side and back
of the legs, and the waist area remains unprotected.
[0006] Still further known undergarments with a pair of cushioned
inserts are shown in U.S. Pat. No. 4,894,867, in which the pads are
relatively small and designed for sports events. Similarly, even
smaller and very thin buttock-protecting pads are provided in a
comfort garment as shown in U.S. Pat. Nos. 5,103,505 and 5,749,101.
Sport pants with larger padding are described in U.S. Pat. No.
5,649,328, in which inner, tight-fitting, and outer, loose-fitting
shorts include inner and outer pads, respectively to provide
cushioning to an in-line skater in case of a fall. While such
garments are generally suitable for their intended purpose, the
padding is either too small to effectively protect back and legs of
a person, or the sports garment is too bulky to be worn as
undergarment. In yet other known garments, the cushioning pad has a
unitary construction that extends across the crotch and is
typically used in bicycling shorts as depicted in U.S. Pat. Nos.
4,961,233, 4,805,243, 5,365,610, and 5,271,101, and U.S. Pat. App.
No. 2003/0131399. While such shorts typically significantly improve
sitting comfort on a bicycle seat, the cushioning area is limited
to the crotch area, which is of little or no help to a person
suffering from lipodystrophy, lipoatrophy, peripheral neuropathy,
and/or sarcopenia.
[0007] Therefore, while numerous padded pants and undergarments are
known in the art, all or almost all of them suffer from one or more
disadvantages. Thus, there is still a need for improved
undergarments that effectively and discreetly provide cushioning
for the legs, buttocks, and belt area of a person wearing such
garment.
SUMMARY OF THE INVENTION
[0008] The present invention is directed to undergarments and
methods therefor, and especially to form-fitted undergarments
having a waist portion with a waist circumference and a leg portion
with a leg circumference, wherein the ratio of the waist
circumference to the leg circumference is higher than normal. Such
undergarments include a padded area configured to provide
preferably continuous protection extending from an upper area of
the waist portion to a lower area of the leg portion such that the
area of the buttocks and legs of a person contacting a seat (while
sitting on a chair) are substantially completely covered by the
padded area.
[0009] Most typically, the higher than normal ratio is
characteristic of a person diagnosed with lipoatrophy,
lipodystrophy, sarcopenia, HIV infection, a neoplastic disease,
and/or chronic diabetes. For example, such contemplated ratios will
be at least 1.9, and more typically at least 2.0 (as compared to a
normal ratio of about 1.6 to 1.8, or lower). It is typically
preferred that at least one of the waist portion and the leg
portion comprises an elastic material, and/or the padded area
extends to a substantially topmost and/or lowermost end of the
waist portion and/or leg portion. Where desirable, the padded area
is configured as an independent right and left area, wherein each
area includes a removable pad. Furthermore, it is contemplated that
the padded area and/or pad includes a plurality of vent openings
and that it is further contoured to have a thicker than average
thickness in the buttock area and optionally a thinner than average
thickness in a peripheral area of the padded area.
[0010] In another aspect of the inventive subject matter, a method
of providing symptomatic relief for a person suffering from HIV
infection, chronic diabetes, neoplastic disease, lipoatrophy,
lipodystrophy, and/or sarcopenia will comprise a step of providing
the form-fitted undergarment according to inventive subject matter
and a further optional step of informing the person that the
undergarment reduces symptomatic discomfort associated with the
conditions indicated above. Moreover, contemplated undergarments
may also be of significant advantage where the patient is a
geriatric patient as advanced age is often accompanied by loss of
muscle tissue and/or fatty tissue in the buttocks and/or legs.
[0011] Alternatively, or additionally, a method of providing
improved sitting comfort to a person is contemplated in which a
form-fitted undergarment having a waist portion, a leg portion, and
a padded area is provided, wherein the padded area is configured to
provide protection extending from an upper area of the waist
portion to a lower area of the leg portion such that the area of
the buttocks and legs of a person contacting a seat (while sitting
on a chair) are substantially completely (i.e., at least 90%, more
typically at least 95%) covered by the padded area. In another
step, the person is informed that the undergarment will provide
reduction in at least one of pain, numbness, local hemostasis, and
deep vein thrombosis when the garment is worn during a prolonged
period of sitting (e.g., over at least one, more typically at least
two, and most typically at least three hours). Most preferably, the
padded area in such methods has an average thickness of between 0.5
inch to 1 inch, and is contoured to have a thinner than average
thickness in a peripheral area of the padded area. Furthermore, it
is generally preferred that the padded area is configured as an
independent right and left area, wherein each area includes a
removable pad.
[0012] Various objects, features, aspects and advantages of the
present invention will become more apparent from the following
detailed description of preferred embodiments of the invention.
BRIEF DESCRIPTION OF THE DRAWING
[0013] FIG. 1 is a photograph of a front view of an exemplary
undergarment according to the inventive subject matter.
[0014] FIG. 2 is a photograph of a rear view of the undergarment of
FIG. 1.
[0015] FIG. 3 is a photograph of a padding insert of the
undergarment of FIG. 1.
[0016] FIG. 4 is a photograph of the foam pad of the padding insert
of FIG. 3.
[0017] FIGS. 5A-5C depict top view (A), bottom view (B), and
schematic/cross-sectional view (C) of the foam pad used in the
clinical study reported herein.
[0018] FIG. 6 is a graph illustrating the increase of length of
sitting without discomfort in study participants using the
undergarment according to the inventive subject matter.
DETAILED DESCRIPTION
[0019] The inventor has discovered that quality of life of a person
diagnosed with lipodystrophy, lipoatrophy, peripheral neuropathy,
and/or sarcopenia can be significantly improved by providing a
form-fitted undergarment that not only accommodates the altered
anatomical features of such persons, but that also provides a
relatively large padding to thereby reduce painful and potentially
destructive pressure to the legs and buttocks during sitting.
[0020] It should be noted that patients diagnosed with the above
conditions will typically exhibit a substantially reduced amount of
muscle and/or fat tissue in the buttock area and/or the posterior
thigh area, which exposes muscles, nerves, and blood vessels to
significant compression and thus renders sitting even over a
relatively short period not only painful but also potentially
damaging to the compressed tissues. Unfortunately, loss of
functional vasculature and neuropathic pain are often common in
such compressed tissues and further decrease sense of well-being
for geriatric and/or patients diagnosed with the conditions listed
above. Viewed from a different perspective, undergarments according
to the inventive subject matter will not only distribute the weight
of a sitting person from a few compression points to a relatively
large area, but will also provide cushioning to the load-bearing
surface of a body while the person is in a sitting position.
Therefore, contemplated undergarments will significantly increase
quality of life, allowing normal daily activities and social life,
and thereby reducing depression and use of analgesics.
[0021] In one particularly preferred aspect of the inventive
subject matter, the undergarment is configured as a form-fitting
undergarment as depicted in FIG. 1. Here undergarment 100 has a
waist portion 110 with an elastic waistband 112 and optional
drawstring 114. The leg portion 120 includes first and second legs
122A and 122B. Waist circumference is schematically indicated by
arrow W, while leg circumference is schematically indicated by
arrow L. In preferred aspects of the inventive subject matter, the
ratio of the waist circumference W to leg circumference L in
contemplated undergarments is higher (e.g., about 1.9-2.1) than a W
to L ratio ordinarily encountered in form-fitted undergarments
(e.g., about 1.6-1.8). While not limiting to the inventive subject
matter, it is generally preferred that the waist is elasticized to
allow a person to wear the undergarment above, at, or below the hip
bones. Thus such garment can be worn with or without belt, or with
loose or close fitted clothing.
[0022] Pads 130A and 130B are disposed in respective pouches (not
shown), which are formed in the rear of the undergarment 100. FIG.
2 depicts a rear view of the undergarment 100 of FIG. 1. Here, the
positioning and configuration of the pads 230A and 230B is more
readily apparent. Most significantly, it should be noted that the
pads in the exemplary embodiment are two separate pads that extend
along the length X from the upper area of the waist portion to the
lower area of the leg portion. In such exemplary undergarment, it
should be noted that X is between about 75% to 95%, more typically
about 80% to 95%, and most typically about 90% to 95% of the entire
length of the garment. Similarly, the pads extend along the width Y
from one side of the leg to the other side of the leg, wherein Y is
typically at least 30% to 40%, and more typically at least 35% to
50% of the leg circumference L. The term "about" as used herein in
conjunction with a numeral refers to a range of the numeral of
+/-5%, inclusive.
[0023] FIG. 3 depicts the removable pad insert 330 of one side of
the undergarment, while FIG. 4 shows the contoured foam pad that is
normally contained in a textile envelope to thereby form the pad
insert of FIG. 3. Here peripheral area 432 has a lower than average
thickness (typically between 1/4 inch and less than 3/4 inch),
while the area proximal and overlapping the buttock area 442 has a
higher than average thickness (typically between more than 3/4 inch
and 1 inch). A substantially horizontal seam may be included that
assists in formation of a pad shape similar to a normal anatomy of
buttocks. Vent openings 436 and lateral cuts 438 assist in heat and
moisture transport across the pad and further allow for extra
deformation. Of course, while the exemplary undergarment of FIG. 1
is depicted for male to users, it should be recognized that
modifications known in the art can be made to accommodate female
and/or pediatric users as well. It should be noted that
contemplated pads and pad inserts may also have flex grooves and/or
flex hinges that allow to the pad to conform to a persons anatomy
while the person is moving. Among other advantages, such
flexibility will reduce or even entirely eliminate the possibility
for the undergarment to ride up or chaff during walking and
sitting.
[0024] Thus, it should be recognized that a (preferably
form-fitted) undergarment will typically include a waist portion
with a waist circumference and a leg portion with a leg
circumference, wherein the ratio of waist to leg circumference is
higher than a normal ratio (see below). Such unusual ratio is not
only considered beneficial in retaining the padded area in a
desired place (prevents the pads from `flopping around`), but is
also though to provide support for the anatomical areas covered.
Where the fit is relatively tight, such support may also provide
drainage and/or vascular support. It is further generally preferred
that a padded area is included that is configured to provide
protection that extends from an upper area of the waist portion to
a lower area of the leg portion. The protection is typically such
that the area of the buttocks and legs of a person contacting a
seat (while sitting on a chair) are substantially completely
covered by the padded area. The term "form-fitted" as used herein
and with respect to a garment refers to a fit of a garment that
generally follows the anatomy of a person. Therefore, and most
typically, form-fitted undergarments will be in substantial
complete (i.e., at least 80%, more typically at least 90%) contact
with the persons body when worn by the person. While not limiting
to the inventive subject matter, the waist portion and/or the leg
portion will comprise an elastic material that assists in the form
fit. As also used herein and with respect to a person, the term
"ratio of waist to leg circumference is higher than a normal ratio"
means that the person's leg circumference relative to the person's
waist circumference is abnormally greater than the same ratio of an
average healthy person. In most cases, a higher than normal ratio
is observed where the leg circumference is significantly reduced
due to lipoatrophy and/or sarcopenia (which may be precipitated by
a disease and/or advanced age [e.g., older than 65, and more
typically older than 75 years]). Such higher than normal ratio may
also (and/or further) be precipitated by exacerbated lipid
accumulation around a person's waist (e.g., due to lipodystrophy)
while having a normal or reduced leg circumference.
[0025] For example, a healthy person with a waist circumference
(measured at about the navel) of about 34 to 40 inches will
typically have a leg circumference (measured at about midpoint
between knee joint and hip joint) of between about 20 and 24,
resulting in a typical ratio of between about 1.60 to 1.80, and
even lower. In contrast, in a person with abnormal and reduced leg
circumference and possible increased waist circumference, the ratio
will typically be between about 1.9 to 2.2, and even higher. Most
commonly, and viewed from a different perspective, ratios that are
considered higher than normal will be those characteristic of a
person diagnosed with lipoatrophy, lipodystrophy, sarcopenia (e.g.,
due to HIV infection, neoplastic disease, advanced age, and/or
chronic diabetes). For example, higher than normal ratios will be
at least 1.85, more typically at least 1.9, even more typically at
least 2.0, and most typically at least 2.1.
[0026] It is further generally preferred that the padded area in
contemplated undergarments will extend to the substantially topmost
end of the waist portion and/or the substantially lowermost end of
the leg portion. Thus, the length X of the padded area is
preferably at least 70%, more preferably at least 80%, even more
preferably at least 90%, and most preferably at least 92% of the
entire length of the undergarment. It should be noted that such
extensive length of the padded area will not only provide the lower
portion of the legs with sufficient padding, but also protect the
spinal area around the iliac crest from pressure of a belt worn
with pants. Thus, the upper end of the padding in at least some of
the embodiments is configured such that the padding extends to a
position that is at, or even above the iliac crest of the hip bone
when the undergarment is worn. In less preferred aspects, however,
the upper end of the padded area may also extend to a position
below the iliac crest (e.g., 1 cm below, less preferably 2 cm
below, and even less preferably 2-6 cm).
[0027] With respect to the lower end of the padding, it is
typically preferred that the lower end extends (preferably at
least) to a position that corresponds to a portion of a leg in
contact with a chair when a person sits on a chair. Therefore,
viewed from another perspective, the lower end of the padding
extends to a position that corresponds to the lower point of
attachment of the adductor longus to the femoral bone, and even
lower (e.g., at least 1 cm, more typically at least 2 cm, and most
typically at least 2-5 cm). Viewed from yet another perspective,
the padding extends to a position that is about 30 cm above the
knee, more typically between 30 cm and 20 cm above the knee, and
most typically between 20 cm and 10 cm above the knee (when the
undergarment is worn on a person). With respect to the width Y of
the padded area in the leg portion, it is generally preferred that
the padded area extends to at least 30% of the leg circumference,
and more typically at least 40% of the leg circumference. Viewed
from a different perspective, the width (and length) of the padding
is preferably selected such that the padding will cover the entire
area of a leg and buttocks that would otherwise make contact with a
seat surface when the person wearing the undergarment is sitting on
a chair. Consequently, it is contemplated that the ratio of padded
area to the entire garment area (inside) is between about 20% to
80%, more typically between about 30% and 70%, and most typically
between about 35% and 65%.
[0028] Most typically, the padded area comprises an independent
right area and left area, each containing at least one padding
element, which is most preferably a removable pad. However, in less
preferred aspects, the padded area may also comprise a single
padding element covering both sides of the body. The padded area
and/or padding elements preferably comprise a plurality of vent
openings through which moisture and heat can dissipate. It is still
further preferred that the padded area and/or padding element is
further contoured to enhance it's functional and/or esthetic
character. For example, it is typically preferred that the padded
area and/or padding elements have a thicker than average thickness
in the buttock area while having a thinner than average thickness
in the periphery of the padded area. The padding will preferably
comprises a molded, or shaped and precut foam pad, which will
typically be made of medical quality foam, high-grade furniture
padding, memory foam, open cell foam, or other elastomeric material
that will retain its shape over a prolonged period of use.
Alternatively, it is also contemplated that the padded area may
comprise a plurality of padded elements that can preferably be
individually inserted, exchanged, and/or removed to either
personalize the undergarment to a particular body shape, and/or to
achieve a desirable body contour while wearing the undergarment. It
should be noted that it is especially preferred that the
undergarment according to the inventive subject matter is worn
underneath a regular pair of pants, and that the undergarment will
therefore serve at least two distinct functions. First and
foremost, contemplated undergarments will reduce if not even
eliminate subjective discomfort associated with sitting. Second,
and especially where the wearer suffers from lipoatrophy and/or
sarcopenia, contemplated undergarments will provide a more
desirable body profile when worn with relatively tight fitting
pants.
[0029] With respect to the padding material, it is generally
contemplated that all elastic materials are suitable, however,
especially preferred materials have an elasticity such that the
padding is compressed to less than about 60% (or less than 30-50%,
or less than 50-60%, but also less than 60-70%, and even higher) of
full compression when a person's weight compresses the padding in
use in garments contemplated herein. Therefore, suitable materials
include high-grade synthetic foam commonly used in medical uses
and/or furniture trade, but also other materials, including memory
foam, optionally foamed polymers (e.g., polyurethane, polyethylene,
etc.), and all reasonable combinations thereof. Furthermore, it
should be recognized that the padding may have a thickness and/or
density that is not even, especially where the material is molded.
For example, areas of higher weight load may have a greater
thickness as compared to areas where less weight load is commonly
expected (e.g., side of the legs). Additionally, or alternatively,
the padding may be configured such that a user can adjust the
thickness (e.g., by adding or removing material).
[0030] In further aspects of the inventive subject matter, it is
contemplated that the padding may be permanently coupled to the
garment (e.g., directly sewn in, or enclosed in a pouch), or that
the padding may be temporarily retained at a predetermined location
(slipped into an envelope, attached via hook-and-loop fasteners,
buttons, snaps, etc.). Still further, in less preferred aspects, it
is contemplated that the entire garment may be fabricated from a
padding, wherein the areas to be protected correspond to areas
contemplated above and are of greater thickness, while the
non-protected areas may be fabricated from a relatively thin
padding. The padding may thereby be added to the garment in a
manner such that the padding or portion thereof forms a portion of
a design element, or in a manner such that the padding is
substantially invisible from the outside of the garment when the
garment is worn on a person.
[0031] Regardless of the particular nature and configuration of the
padding, it is contemplated that the non-padding portion of the
undergarment may be formed from all materials known in the art, and
particularly suitable materials include cotton, synthetic and
natural fibers, wool, and all reasonable combinations thereof. For
example, especially suitable materials include wicking fabrics, and
particularly lycra, polyester, spandex, and all reasonable
combinations thereof. Moreover, preferred materials also include
fabric with added or built-in antimicrobial properties. Still
further, it is contemplated that padding to reduce painful
conditions (e.g., due to lipodystrophy, lipoatrophy, and/or
sarcopenia) may be included in clothing articles other than
undergarments. Therefore, contemplated alternative garments include
shorts, pants, shirts, shoes, socks, etc., wherein the padding is
provided in areas to reduce pressure to one or more anatomic
structures. In still further contemplated aspects, the undergarment
may also be made from a material with sufficient resiliency to
allow formation of a compression garment that supports and
compresses a wearers body.
[0032] Especially contemplated uses include those in which
symptomatic relief from pain and other discomfort associated with
HIV infection, chronic diabetes, neoplastic disease, lipoatrophy,
lipodystrophy, sarcopenia, and/or advanced age is provided by
wearing the undergarment according to the inventive subject matter.
Additionally, the inventor observed that contemplated undergarments
also provide relief from generalized or non-specific hip and pelvic
pain, which may be due to injury, osteoarthritis, and/or
osteonecrosis (or other unknown etiology). Such methods may further
include various steps of providing information that the
undergarment will provide symptomatic relief, improve appearance,
quality of life, and/or reduce pain in a person wearing the
undergarment. Information may be provided in numerous manners,
including pictorial information, written description, and/or
auditory information. Consequently, advantages and properties of
contemplated undergarments may be advertised on a sales brochure,
on the packaging in which the undergarment is contained, in
websites, etc. Therefore, target markets for such undergarments
will include geriatric patients, HIV patients, post-surgical
patients with hip and/or thigh bone surgery.
[0033] Further contemplated uses include those for healthy persons
that are subject to relatively long periods of sitting. For
example, a method of providing improved sitting comfort to a person
may include a step in which a form-fitted undergarment having a
waist portion, a leg portion, and a padded area is provided,
wherein the padded area is configured to provide protection
extending from an upper area of the waist portion to a lower area
of the leg portion such that buttocks and legs of a person
contacting a seat while sitting on a chair are substantially
completely covered by the padded area (average thickness of between
0.5 inch to 1 inch). In another step, the person is informed that
the undergarment provides reduction in at least one of pain,
numbness, local hemostasis, and deep vein thrombosis when the
garment is worn during a period of sitting over at least three
hours. While such persons are typically of advanced age, younger
persons are also expressly contemplated herein. With respect to the
undergarment, materials, and dimensions, similar, or even same
considerations as described above apply.
EXAMPLES
[0034] To determine the impact of the form-fitted undergarments
according to the inventive subject matter in persons with
lipoatrophy of the legs and buttocks and sitting pain on sitting
comfort, quality of life and the ability to participate in sitting
activities associated with various life activities, the following
study was performed.
Product Tested
[0035] The form-fitted undergarment used in this study (LipoWear
Shorts) had the following features: Foam pads were anatomically
designed for sitting pain relief and had the general shape as
depicted in FIGS. 5A-5C. As can be seen from FIG. 5A, the top sides
of the padding inserts were profiled top-to-bottom and
side-to-side, and included two non-perforating cutouts to assist
flexing of the padding in the central area of the buttocks. The
bottom sides of the padding included a plurality of vent openings
perforating the thickness of the padding and having a geometry in
which the opening proximal to the skin has a larger diameter that
the opening distal to the skin as shown in FIG. 5B. Moreover, a
non-perforating cutout was provided to assist flexing of the
padding to conform to the posterior iliac crest. The vent openings
were provided to allow heat loss, and the padding was further
covered by a fabric layer on the skin side that allowed wicking of
perspiration. An adjustable waist band was provided and the
undergarment was form-fitted to be contoured to the body. As can be
seen from FIG. 5C, the padding was shaped such that at least 70% of
the top and bottom sides were profiled in a curved profile to both
conform to the anatomy of the wearer but also to add material in a
manner that would result in a more natural look of the wearer. Foam
pads were inserted into respective pockets of an elastic
undergarment that was cut and sewn to be form fitted for a waist to
leg circumference ratio of at least 1.9.
Study Design
[0036] Subjects meeting the protocol criteria were enrolled in a
two month, open label study at three HIV private practices in
southern California.
[0037] Subject Inclusion Criteria: Male, small waist size at 28-30
inches or medium waist size at 32-34 inches; age 18 or older;
HIV-infected; presence of lipoatrophy in the legs and buttocks;
presence of pain and discomfort when sitting; English speaking and
capable of completing questionnaires & diaries; able to
complete 2 month study.
[0038] Subject Exclusion Criteria: Substance abuser; mental
instability likely to interfere with study participation; scheduled
medical procedure requiring hospitalization during 2 month study;
allergic to synthetic fabrics or foam.
Main Outcome Measures
[0039] Sitting pain relief and Quality of Life improvement as
measured by Multidimensional Quality of Life Questionnaire for
Persons with HIV/AIDS (MQOL-HIV) developed by the New England
Research Institutes, Inc. Four of the ten domains in the MQOL-HTV
where pain relief would potentially provide a benefit were selected
for analysis: Physical Function, Social Function, Cognitive
Function and Mental Health. Each Domain had four questions. Each
question was scored on a 7 point Likkert scale. The scores for
certain questions are reversed so that an increase in score
represents an increased quality of life. In addition, sleep
restlessness was evaluated on a 5 point scale from not restless to
extremely restless. Outcome measures were determined at baseline, 1
and 2 months. Statistical analysis compared baseline and month 2
endpoints.
Statistical Methodology
[0040] Sitting comfort time was evaluated using a one-sided t-test.
Sleep restlessness was evaluated using a one-sided, matched pairs
t-test. Quality of Life mean scores were evaluated using two
methodologies, the matched pairs t-test and the Wilcoxon sign-rank
test, a nonparametric test.
Results
[0041] 31 subjects were enrolled in the study and 24 completed the
two month evaluation. Five subjects dropped out due to medical
complications that prevented them from making office visits. Two
subjects dropped out due to inappropriate size issues.
[0042] The mean age of the subjects completing the study was 53 and
the mean length of HIV antiviral treatment was 10 years. The degree
of lipoatrophy in the buttocks and legs was determined by
participating physicians. Three subjects (12.5%) exhibited mild
lipoatrophy, 10 subjects (41.67%) were judged as moderate, and 11
subjects (45.83%) were judged as severe. Baseline sitting comfort
decreased as the degree of lipoatrophy severity increased as shown
in Table 1:
TABLE-US-00001 TABLE 1 Sitting Comfort & Degree of Lipoatrophy
Baseline Sitting Degree of Lipoatrophy Number of Subjects Comfort
(minutes) Mild 3 23 Moderate 10 13 Severe 11 7 Mean of all
categories 11.58
Sitting Comfort
[0043] The study demonstrated a statistically significant increase
in sitting comfort. At baseline, subjects were able to sit
comfortably for a mean of 11.58 minutes. At the two month
conclusion of the study, mean comfortable sitting time had
increased to 189 minutes (p=0.0001). FIG. 6 illustrates the
significant change in mean length of sitting comfort time.
Sleep Restlessness
[0044] Sleep restlessness improved significantly (p=0.0008). 16 of
the 24 patients improved one or more levels, 6 stayed the same and
2 reported increased restlessness as shown in Table 2.
TABLE-US-00002 TABLE 2 Change in Sleep Restlessness Baseline Month
2 Matched Pairs Wilcoxon Sign- Mean Mean Difference T-Test Prob
< t Rank Prob < Z 2.66676 1.75000 -.09167 .0008 .001
Quality of Life
[0045] All four Domains of the Quality of Life evaluated improved
over the 2 month study. The study demonstrated a statistically
significant increase in the mean scores of two Domains, Physical
Function and Social Function (p=0.02). The mean scores of the
Mental Health and Cognitive Function Domains improved at the p=0.1
level as can be taken from Table 3.
TABLE-US-00003 TABLE 3 Quality of Life Composite Domain Analysis
Wilcoxon Month 2 Matched Pairs Sign-Rank Variable Baseline Mean
Mean Difference T-test Prob > t Prob > Z Mental Health Domain
Total 18.08 19.39 1.31 0.105 0.072 Physical Function Domain Total
17.88 20.13 2.26 0.020 0.032 Social Function Domain Total 19.17
20.83 1.65 0.023 0.019 Cognitive Function Domain 20.38 21.57 1.19
0.110 0.290 Total
[0046] When the 4 questions in each Domain were analyzed
individually, the sample means of 15 out of 16 questions improved,
and one remained unchanged. In the Mental Health Domain, depression
improved significantly (p=0.045). In the Physical Function Domain,
doing more around the house and doing more outside the house
improved significantly (p=0.007 and 0.014 respectively). In the
Social Function Domain, feeling isolated, lacking energy to
socialize and spending quality time with friends improved
significantly (p=0.043, 0.035, and 0.004 respectively). In the
Cognitive Function Domain, trouble remembering things and short
attention span improved at the p=0.058 and 0.082, respectively, as
can be seen from Table 4.
TABLE-US-00004 TABLE 4 Domain Question Analysis Wilcoxon Month 2
Matched Pairs Sign-Rank Baseline Mean Mean Difference T-test Prob
> t Prob > Z Mental Health Q1 "You felt depressed" 4.87 5.43
0.57 0.045 0.019 Q2 "You felt anxious" 5.09 5.43 0.35 0.194 0.205
Q3 "You felt needed" 3.91 3.96 0.04 0.439 0.443 Q4 "You worried
about things" 4.13 4.57 0.43 0.102 0.090 Physical Function Q9 "do
things around house" 4.52 5.43 0.91 0.007 0.008 Q10 "get from place
to place" 5.35 6.00 0.65 0.014 0.016 Q 11 "climb stairs" 5.17 5.22
0.04 0.454 0.608 Q 12 "perform strenuous 3.13 3.48 0.35 0.143 0.176
sports" Social Function Q 13 "You felt isolated" 4.95 5.45 0.50
0.043 0.060 Q 14 "withdrawn from 5.18 5.18 0.00 0.500 0.531
socializing" Q 15 "lacked energy to 4.73 5.27 0.55 0.035 0.047
socialize: Q 16 "spent quality time with 4.23 4.91 0.68 0.004 0.006
friends" Cognitive Function Q 21 "trouble remembering 4.83 5.26
0.43 0.058 0.065 things" Q 22 "forgetting what you 4.96 5.17 0.22
0.244 0.250 started" Q 23 "mind wanders" 5.13 5.35 0.22 0.229 0.258
Q 24 "short attention span" 5.30 5.78 0.48 0.082 0.123
[0047] As a result of sitting pain relief, subjects reported being
able to participate longer and concentrate better in a wide variety
of activities including: choir, church, computer time, concerts,
doing bills, driving, meditation, meetings, movies, plane travel,
reading, restaurants, school, seminars, shopping, socializing,
theater, walking, watching TV, work, writing letters, yard work and
yoga. This expansion in activities contributed to the improved
Quality of Life Rating scales in the multiple domains noted
above.
[0048] In general, subjects also reported decreased use of pain
medications, rated the quality of their life as improved
significantly, rated their appearance as improved significantly and
to rated the product as very useful. Multiple comments were
received from the subjects as to the importance of the padded
shorts restoring a normal body contour which resulted in an
improved appearance. 100% would recommend the product to
others.
Discussion
[0049] The emergence of lipoatrophy and subsequently sitting pain
as an important clinical component of long term HIV treated
subjects has lead to the recognition of the impact of sitting pain
on the lives of these subjects. As a result of this often
debilitating sitting pain, withdrawal from activities increases
which results in a decreased quality of life. This study shows that
a discreet, anatomically designed, padded undergarment allows
subjects extended sitting comfort and improved appearance which in
turn allows them to return to activities reduced or abandoned and
increases the quality of life. LipoWear Shorts significantly
improved sitting pain comfort and appearance and significantly
increased the quality of life in subjects with lipoatrophy and
sitting pain
[0050] Thus, specific embodiments and applications of functional
undergarments have been disclosed. It should be apparent, however,
to those skilled in the art that many more modifications besides
those already described are possible without departing from the
inventive concepts herein. The inventive subject matter, therefore,
is not to be restricted except in the spirit of the appended
claims. Moreover, in interpreting both the specification and the
claims, all terms should be interpreted in the broadest possible
manner consistent with the context. In particular, the terms
"comprises" and "comprising" should be interpreted as referring to
elements, components, or steps in a non-exclusive manner,
indicating that the referenced elements, components, or steps may
be present, or utilized, or combined with other elements,
components, or steps that are not expressly referenced.
Furthermore, where a definition or use of a term in a reference,
which is incorporated by reference herein is inconsistent or
contrary to the definition of that term provided herein, the
definition of that term provided herein applies and the definition
of that term in the reference does not apply.
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