U.S. patent application number 14/042079 was filed with the patent office on 2014-01-30 for site guard for intravenous sites and other sensitive areas.
The applicant listed for this patent is Betty M. Rozier, Lisa M. Vallino. Invention is credited to Betty M. Rozier, Lisa M. Vallino.
Application Number | 20140031757 14/042079 |
Document ID | / |
Family ID | 26724300 |
Filed Date | 2014-01-30 |
United States Patent
Application |
20140031757 |
Kind Code |
A1 |
Rozier; Betty M. ; et
al. |
January 30, 2014 |
SITE GUARD FOR INTRAVENOUS SITES AND OTHER SENSITIVE AREAS
Abstract
A multipurpose site guard for use at all peripheral and central
venipuncture infusion sites, sensitive areas, and for pediatric and
adult patients. The guard is a hollow plastic member with a base
and a sidewall that forms a cover over the site. Improvements to
this invention include holding the guard in place with a fabric
connector having closure means, cushioning the guard's base with a
soft material, and a hole disposed in the hollow member for
providing access to the site.
Inventors: |
Rozier; Betty M.;
(Chesterfield, MO) ; Vallino; Lisa M.; (Saint
Louis, MO) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Rozier; Betty M.
Vallino; Lisa M. |
Chesterfield
Saint Louis |
MO
MO |
US
US |
|
|
Family ID: |
26724300 |
Appl. No.: |
14/042079 |
Filed: |
September 30, 2013 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
13183025 |
Jul 14, 2011 |
|
|
|
14042079 |
|
|
|
|
10501604 |
Oct 28, 2004 |
8006699 |
|
|
PCT/US03/01216 |
Jan 15, 2003 |
|
|
|
13183025 |
|
|
|
|
10046800 |
Jan 15, 2002 |
|
|
|
10501604 |
|
|
|
|
09608648 |
Jun 30, 2000 |
6526981 |
|
|
10046800 |
|
|
|
|
60349828 |
Jan 16, 2002 |
|
|
|
60261892 |
Jan 16, 2001 |
|
|
|
Current U.S.
Class: |
604/179 |
Current CPC
Class: |
A61M 2025/028 20130101;
A61M 2025/0266 20130101; A61M 2025/026 20130101; A61M 2025/0246
20130101; A61M 25/02 20130101 |
Class at
Publication: |
604/179 |
International
Class: |
A61M 25/02 20060101
A61M025/02 |
Claims
1. A site guard, comprising: (a) a hollow member having a base, the
base having an edge to be positioned upon a patient adjacent a
site, the base having a width sufficient to straddle the site and a
length and a height sufficient to cover the site, the base joined
to a sidewall to form a cover; (b) at least one fabric connector
affixed to the hollow member; (c) means for affixing the hollow
member to the at least one fabric connector; and (d) means for
closing the fabric connector on the patient.
2. The site guard as recited in claim 1, wherein the closure means
is located on at least one of the base or the sidewall of the
hollow member.
3. The site guard as recited in claim 2, wherein the closure means
comprises at least one of an adhesive or hook and loop
fasteners.
4. The site guard as recited in claim 2, wherein the hollow member
further comprises a strip configured to cover the closure means
when not in use.
5. The site guard as recited in claim 1, wherein the closure means
comprises a first tab and a plurality of holes configured to
receive the first tab.
6. The site guard as recited in claim 5, wherein the first tab is
selected from the group consisting of an adhesive tab and a button
tab.
7. The site guard as recited in claim 5, wherein the at least one
fabric connector further comprises the plurality of holes.
8. The site guard as recited in claim 7, wherein the hollow member
further comprises the first tab.
9. The site guard as recited in claim 8, wherein the at least one
fabric connector further comprises a connector hole and the hollow
member further comprises a second tab, wherein the connector hole
is configured to receive the second tab.
10. The site guard as recited in claim 1, wherein the closure means
comprises a support integrated with the at least one fabric
connector.
11. The site guard as recited in claim 1, wherein the hollow member
and the at least one fabric connector comprise the affixing means,
the affixing means of the hollow member configured to detachably
couple to the affixing means of the at least one fabric
connector.
12. The site guard as recited in claim 1, wherein the at least one
fabric connector comprises a plurality of perforations.
13. The site guard as recited in claim 1, wherein the at least one
fabric connector comprises a plurality of connection points.
14. The site guard as recited in claim 1, wherein the at least one
fabric connector comprises an extender.
15. The site guard as recited in claim 1, wherein the hollow member
further comprises a flange attached to the edge of the support.
16. The site guard as recited in claim 15 further comprising a
cushion attached to the flange.
17. The site guard as recited in claim 1, wherein the at least one
fabric connector further comprises at least one opening to
accommodate various body parts.
18. The site guard as recited in claim 1, further comprising a
cushion affixed to all or part of the edge of the hollow
member.
19. The site guard as recited in claim 40, wherein the cushion is
selected from the group consisting of cloth, gauze, stretch wrap,
and foam tape.
20. The site guard as recited in claim 1, wherein the hollow member
has an elongated closed end, the base is U-shaped, and the base is
split into two legs so as to lay flush against a patient's skin
when used.
Description
RELATED APPLICATION DATA
[0001] This application claims priority to U.S. patent application
Ser. No. 13/183,025 filed on Jul. 14, 2011 which is a continuation
application of U.S. patent application Ser. No. 10/501,604, filed
Oct. 28, 2004 which issued on Aug. 30, 2011 as U.S. Pat. No.
8,006,699, which is a national stage entry of PCT/US03/01216, filed
Jan. 15, 2003, which claims priority to U.S. Provisional Patent
Application No. 60/349,828, filed Jan. 16, 2002, and is a
continuation-in-part application of U.S. patent application Ser.
No. 10/046,800, filed Jan. 15, 2002, which is a
continuation-in-part application of U.S. patent application Ser.
No. 09/608,648, filed Jun. 30, 2000 which issued on Mar. 4, 2003 as
U.S. Pat. No. 6,526,981, and claims priority to U.S. Provisional
Application No. 60/261,892, filed Jan. 16, 2001 and to
PCT/US01/2088, filed Jun. 29, 2001, the entire disclosures of which
are incorporated herein by reference.
FIELD OF INVENTION
[0002] The present invention relates to a guard for protecting
sites on the body, including a fabric connector with closure means
that holds the guard in place without applying adhesive to a
patient's body.
BACKGROUND OF INVENTION
[0003] Parenteral administration of therapy is a common and often
life-saving medical technique. Perhaps its most common form is
peripheral intravenous (IV) infusion, a high volume, high risk,
high cost therapy that affects virtually all patient populations in
all healthcare settings. In this procedure, a needle breaks a
patient's skin and enters a vein, and additional equipment delivers
therapeutic infusates such as antibiotics, hydration fluids,
hyperalimentation, pain management drugs, chemotherapy drugs,
indigestible drugs, or blood products into the body. Similar
equipment may drain harmful fluids away from the body, such as
fluids accumulating around infected wounds or emptying into
colostomy bags. Patients may receive IV or other parenteral therapy
for a few hours, a few days, a few weeks, a few months, or even
years.
[0004] On the human body, there are a number of possible
venipuncture sites. The scalp, upper extremity and lower extremity
contain many peripheral venipuncture sites; the basilic vein in the
antecubital area is the best vein for placement of midline
catheters, another type of peripheral venous access device that can
tolerate longer dwell times, while central venipuncture sites may
access the superior vena cava.
[0005] The major superficial veins of the scalp are the frontal,
superficial temporal, posterior auricular, supraorbital, occipital
and posterior facial. In the upper extremity, venipuncture sites
include the cephalic, median basilic and median antecubital veins,
as well as the dorsal venous arch. The saphenous veins, the median
marginal veins and the veins of the dorsal arch of the lower
extremities are also used.
[0006] Central venous access is achieved when the catheter tip of
the access device is located in the lower one-third of the superior
vena cava close to its junction with the right atrium of the heart.
Central venipuncture sites include the external jugular, the
internal jugular or the subclavian vein. The inferior vena cava is
entered through the femoral vein. Central access to the superior
vena cava is commonly achieved through peripherally inserted
central catheters known as PICC lines, which are inserted in the
antecubital area into the basilic vein and may take the place of
multiple repeated peripheral IVs.
[0007] The selection of an IV site depends on a host of
considerations including the age of the patient, condition of the
patient, what kind of fluid is to be infused, rate at which the
fluid is to be infused and so forth. In general, if the patient is
an adult, the best venipuncture sites, in order of preference, are
the lower arm and hand, the upper arm, and the antecubital fossa.
If the patient is an infant, a scalp vein may be used because it is
accessible and when other peripheral attempts have failed.
[0008] Needles and catheters of various sorts are used for IV
infusions. In the past, the same needle used to puncture the vein
was also used for infusing the fluid. Present practice, however, is
to infuse the fluid through a catheter that is planted with a
needle which is then withdrawn. Currently there are two major types
of catheters--namely, over-the-needle catheters and
through-the-needle catheters. A third type, steel butterfly
needles, formerly used in treating children, have been superseded
by over-the-needle catheters.
[0009] Old fashioned needles and modern catheters terminate in a
hub for connection to a fluid supply line by means of a separable
tapered part. The friction joint between the hub and the supply
line sometimes becomes detached even with a threaded locking
connector such as a luer lock. When this happens, fluid is lost and
the patient may be seriously affected beyond the value of the fluid
lost. Needles and catheters are also subject to inadvertent
displacement whereby the needle or catheter is withdrawn from the
vein or perforates the vein's opposite wall causing the infused
fluid to infiltrate and swell the surrounding tissue. This thwarts
infusion therapy and causes other problems. Displacement of the
needle or catheter is particularly likely when the venipuncture
infusion site is adjacent a joint.
[0010] Agencies such as the Center for Disease Control require that
catheters be changed every 48 hours if an institution has an
incidence of phlebitis greater than 5%, and every 72 hours if the
incidence of phlebitis is less than 5%. However, such agencies seek
to extend catheter dwell time to 96 hours. Prolonging the lifespan
of peripheral catheters benefits patients by decreasing the number
of IV starts, decreasing infection due to fewer needlesticks,
decreasing the incidence of thrombus, decreasing the cost of IV
start supplies, decreasing nursing time and physiologic cost to the
patient, and in some cases, fewer interruptions in nutritional
therapy. Also, increasing the dwell time can salvage more veins for
use at a later date.
[0011] The simplest way to stabilize the joint between the hub and
the supply line and to prevent the needle and catheter from being
displaced is with adhesive tape (after application of a transparent
dressing that maintains sterility). The supply line tubing is taped
to the patient over the transparent dressing and "looped," or
directed, back to its source. This loop needs to be secure to
prevent mechanical catheter manipulation, so that the needle or
catheter is less likely to become dislodged if the tubing is
accidentally bumped or pulled. If the venipuncture site is adjacent
a joint, the joint is often immobilized.
[0012] If the IV equipment is taped but otherwise unguarded, the
catheter may still be accidentally dislodged or, in the case of
adult patients with impaired senses or involuntary movement and
pediatric patients, pulled out by the patient or one of his
caregivers or visitors. A taped but otherwise uncovered infusion
site may frighten pediatric patients and be a stressor even to
adults, particularly if they are very old or sick.
[0013] In addition to tape, devices have been proposed for guarding
the needle or catheter at the infusion site and for protecting the
joint between the needle or catheter and the supply line. Many of
these devices are specially designed for use at a particular
infusion site and are big, expensive and mechanically complicated.
For example, there are devices with domes over the infusion site
and with means for immobilizing the elbow joint for intravenous
infusion adjacent the joint of an adult. There are other special
purpose devices for protecting the infusion site on a child's scalp
and so forth.
[0014] The applicants' U.S. Pat. No. 5,167,240 and Des. 335,926
teach a hollow member to cover puncture sites made by IV needles
(the "I.V. HOUSE".RTM.). Through principles of blow dispersion and
absorption, the I.V. HOUSE helps protect sites such as injection
sites which are a catheter length away from the infusion sites, as
well as venipunctures and their accompanying IV needles and
catheters from being bumped or pulled. The I.V. HOUSE is used in
the health care industry on adult and pediatric patients.
[0015] Hollow members are usually secured in place by adhesives
such as tape. However, the use of adhesives is problematic for many
patients as epidermal stripping may occur. Patients may have
external or subsurface conditions adjacent a site that may be
irritated or exacerbated by the adhesive's chemicals, by the tape's
nonporous nature, or by the mechanical pulling needed to remove the
tape. Some patients are immunocompromised or sensitive or allergic
to the adhesive, or become so during the course of treatment. The
skin of geriatric and pediatric patients, especially neonates,
tends to be sensitive even when healthy. Other patients have
unhealthy skin, such as patients suffering from diseases of or
affecting the skin including but not limited to Stevens-Johnson
syndrome, skin cancer, acne, allergic rashes or general dermatitis,
and may also be harmed by the use of adhesives. The sensitivity of
patients' skin with burns, for example from fire, the sun, contact
with chemicals or chemotherapy treatments, presents enormous
difficulties in protecting IV puncture sites and other surface or
subsurface problems. Many patients have varying concentrations of
hair on their skin, making tape painful to remove unless the site
is clipped with scissors. Patients with these or other skin
conditions may suffer mild to severe itching, rashes, blisters,
open sores, sloughing of the skin, even scars, among other things,
from the use of adhesives on their skin. In the worst case, removal
of the tape can cause epidermal stripping, removal of a layer of
skin, when the adhesive is removed in patients with fragile
skin.
[0016] Using tape to secure hollow members has other difficulties.
When the environment or the patient's skin becomes moist, for
instance in humid climates or patients who perspire profusely,
adhesives may loosen and thus lose their supportive value. Tape
does not adhere well to raw, burned, or otherwise unhealthy skin,
or to sites in irregular places such as the head. Adhesives also
loosen if they are moved too much, or if they do not have a solid
flush surface to stick to. Furthermore, tape can stick to a health
care provider's glove and tear it, potentially exposing the worker
to bloodborne pathogens and compounding concerns about introducing
new infections to a patient.
[0017] In view of the above, there is a continuing need for a
general-purpose guard for a variety of sites on pediatric and adult
patients. However, the use of tape to secure a hollow member over
one or more sites creates problems in a variety of patients. The
present invention seeks to allay that problem.
SUMMARY OF INVENTION
[0018] The site guard of the present invention avoids difficulties
with adhesives by securing a protective hollow member to one or
more desired sites with a fabric connector that does not use
adhesives on patients' skin. Besides protecting patients from
exposure to adhesives, the inventive site guard's universal design
and use is more adaptable to irregular or hirsute body surfaces
than those secured to patients' skin with adhesives. The site guard
adapts well to humid environments and allows for better
stabilization of IV sites in cases where tape is inadequate or
painful, such as on the sensitive skin of geriatric patients and on
neonatal and other pediatric patients, and when patients' skin is
otherwise moist, sensitive or unhealthy. Overall, the use of a
fabric connector to secure a hollow member over a site helps
maintain the integrity of healthy and unhealthy skin and reduces
irritation caused by tape in contact with skin or device in contact
with skin.
[0019] The site guard of the present invention comprises a hollow
member affixed to a fabric connector. The hollow member has a base
with an edge to be positioned upon a patient adjacent a site,
dimensioned so as to completely cover the site. The fabric
connector is removably or permanently affixed to the hollow member
to hold the site guard in place over the site. The present
invention also includes a method for protecting a site, comprising
placing a hollow member over the site and securing it to a patient
with a fabric connector having closure means that avoids applying
adhesive to the patient's skin.
[0020] The site guard's easy-to-fasten fabric connector benefits
at-home patients; in some embodiments, the entire apparatus may be
removed, washed and reused. It also improves stability over tape in
active patients apt to dislodge their IV inserts, such as active
children, epileptic, patients with involuntary movements, delirious
or physically aggressive patients, or patients who are simply out
of bed and ambulatory.
BRIEF DESCRIPTION OF THE FIGURES
[0021] The accompanying drawings illustrate various embodiments of
the contemplated invention. Corresponding reference characters
refer to corresponding parts throughout the several views of the
drawings, and in which:
[0022] FIG. 1a is a plan view of the top of the site guard of the
present invention, where the fabric connector is affixed to the
lower edge and inner sidewall of the hollow member.
[0023] FIG. 1b is a perspective view of the site guard of the
present invention.
[0024] FIG. 1c is a plan view of the bottom of the site guard of
the present invention.
[0025] FIG. 1d is a plan view of a hand with a site.
[0026] FIG. 1e is a plan view of a hand with a site covered by a
site guard.
[0027] FIG. 2a is a plan view of the top of the site guard of the
present invention, where the fabric connector is completely
separate from the hollow member.
[0028] FIG. 2b is a perspective view of the site guard of the
present invention, where the fabric connector is removably affixed
to the inner dome of the hollow member.
[0029] FIG. 2c is a plan view of the bottom of the site guard of
the present invention, where the fabric connector is removably
affixed to the inner dome of the hollow member.
[0030] FIG. 3a is plan view of the top of the site guard of the
present invention, with the fabric connector affixed to the lower
edge and inner sidewall of the hollow member.
[0031] FIG. 3b is a perspective view of the site guard of the
present invention.
[0032] FIG. 3c is a plan view of the bottom of the site guard of
the present invention.
[0033] FIG. 4a is a plan view of the top of the site guard, with
the fabric connector affixed to the outer sidewall of the hollow
member.
[0034] FIG. 4b is a perspective view of the site guard of the
present invention.
[0035] FIG. 4c is a plan view of the bottom of the site guard of
the present invention.
[0036] FIG. 5a is a plan view of the top of the site guard of the
present invention, where the fabric connector may be removably
affixed to the outer dome and outer sidewall surfaces of the hollow
member.
[0037] FIG. 5b is a perspective view of the site guard of the
present invention.
[0038] FIG. 5c is a plan view of the bottom side of the site guard
of the present invention.
[0039] FIG. 5d is a plan view of the site guard covering a site on
a hand.
[0040] FIG. 6a is a plan view of the top of the site guard of the
present invention, where the fabric connector is completely
separate from the hollow member.
[0041] FIG. 6b is a plan view of the site guard of the present
invention, completely assembled.
[0042] FIG. 7a is a plan view of the site guard of the present
invention, where the tubular mesh fabric connector is completely
separate from the hollow member.
[0043] FIG. 7b is a perspective view of a tubular fabric connector,
turned inside-out to expose Velcro strips inside the fabric
connector.
[0044] FIG. 7c is a perspective view of the site guard of the
present invention, completely assembled, with the fabric connector
affixed to the hollow member.
[0045] FIG. 8 is a perspective view of an embodiment of the site
guard.
[0046] FIG. 9 is a perspective view of an embodiment of the site
guard.
[0047] FIG. 10a is a perspective view of an embodiment of the
fabric connector.
[0048] FIG. 10b is a perspective view of an embodiment of the site
guard.
[0049] FIG. 10c is a back plan view of an embodiment of the site
guard.
[0050] FIG. 11 is a perspective view of an embodiment of the site
guard.
[0051] FIG. 12a is a perspective view of an embodiment of the
fabric connector.
[0052] FIG. 12b is a perspective view of an embodiment of the site
guard.
[0053] FIG. 13 is a perspective view of an embodiment of the site
guard.
[0054] FIG. 14a is a perspective view of an embodiment of the site
guard.
[0055] FIG. 14b is a perspective view of the embodiment of the site
guard shown in FIG. 15 rotated 180 degrees.
[0056] FIG. 15 is a perspective view of an embodiment of the site
guard.
[0057] FIG. 16 is a perspective view of an embodiment of the site
guard.
[0058] FIG. 17a is a top plan view of an embodiment of the utility
strap.
[0059] FIG. 17b is a perspective view of an embodiment of the site
guard including the utility strap as used on a hand.
[0060] FIG. 18a is a top plan view of an embodiment of the hollow
member including a member flange.
[0061] FIG. 18b is a right side view of the embodiment of the site
guard shown in FIG. 18a.
[0062] FIG. 19 is a top plan view of an embodiment of the site
guard.
[0063] FIG. 20 is a top plan view of the extender for the fabric
connector.
[0064] FIG. 21a is a plan view of an embodiment of a site
guard.
[0065] FIG. 21b is a plan view of an embodiment of a site
guard.
[0066] FIG. 21c is a plan view of an embodiment of a site
guard.
[0067] FIG. 21d is a plan view of an embodiment of a site
guard.
[0068] FIG. 21e is a plan view of an embodiment of a site
guard.
[0069] FIG. 22 is a plan view of an embodiment of the hand
chart.
DETAILED DESCRIPTION OF THE INVENTION
[0070] In general, the present invention relates to a site guard
comprising a hollow member and a fabric connector having closure
means to hold it in place over a site without applying adhesive to
a patient's skin. The present invention may be embodied in many
different forms. The discussion and drawings herein show a few
specific embodiments with the understanding that the present
disclosure is only an exemplification of the principles of the
invention, and is not intended to limit the invention to the
embodiments illustrated.
[0071] As used herein, "site" includes but is not limited to any
wound, any opening, or any lesion in the skin, or more than one
wound, opening or lesion, such as those made by needles and those
made for peripheral or midline catheters, central venipuncture
venous access catheters, tunneled catheters, nontunneled
percutaneous central catheters; colostomy or ostomy bags, surgical
drains; subcutaneous injections, pumps, subcutaneously implanted
central venous access ports, implanted chest ports, implanted
peripheral ports, subcutaneous implanted cardiac devices such as
pacemakers and defibrillators; for AV fistulas, venous grafts or
synthetic tubes used to create AV fistulas, or totally implanted
dialysis access systems used in dialysis. "Site" includes
accompanying equipment, for instance equipment present at an
intravenous site: IV catheter, extension tubing, luer lock tubing,
a loop of tubing, a catheter, locking mechanism (e.g. leur lock),
extension tubing, transparent dressing, and tape, or wound, opening
and lesion dressing materials such as gauze. Sites that may benefit
from the present invention also include but are not limited by any
cut or condition of the skin; and any cut or condition below the
skin's surface that could benefit from surface protection, such as
bone fractures, tissue swellings, burns, insect bites, excisions,
sutures.
[0072] As used herein, hollow member 12 includes but is not limited
to the portion of a site guard dimensioned so as to form a
protective cover over a site, including a base with an edge to be
positioned upon a patient's skin adjacent a site. Hollow members 12
may be made in a variety of shapes and sizes, such as elongate,
circular, square, irregular or any other shaped bases and covers,
and small sizes to fit neonates or small body parts. For sites that
do not require an open-ended hollow member 12, for example sites
without IV tubing, a fully closed hollow member 12 (FIGS. 7a, 7c)
may be used to protect the site, as indicated by a health care
provider.
[0073] As used herein, fabric connector 14 includes but is not
limited to one or more pieces of any material, woven or non-woven,
preferably breathable, including but not limited to a tubular
material such as a mesh, stretch wrap, burn net, gauze, cotton
cloths or blends, latex-free materials, soft cloth, Lycra, nylon,
single or multiple phase polymeric materials such as Tyvek or
polypropylene and polytetrahydrofluoroethylene (PTFE, made by
Gortex.RTM.), tape wrap, a porous mesh, a stretchy fabric, a
transparent material such as certain plastic or nylon or blends.
Combinations of these materials are also contemplated, as is their
treatment with porous polymers such as PTFE. For instance, the use
of a porous fabric allows for better protection of patients'
surface or subsurface injuries in humid environments, patients with
a tendency to perspire, and patients who are active. A stretch wrap
may also be useful for active patients, or those whose injuries are
located in irregularly contoured areas. Additionally, the fabric
connector 14 may include a material with sufficient stretch to
allow the lifting of the hollow member so that the site may be
inspected while the site guard is in use. A fabric connector 14
could be square, round, tubular, "X" shaped, or any other shape so
long as it secures the hollow member to the patient. One benefit of
an "X" shaped fabric connector 14 is to avoid occluding one or more
strategically placed ventilation holes. In use, a fabric connector
14 with excess material may be cut to size when a site guard is
applied to a patient. Extended length fabric connectors 14 may be
utilized for larger sized patients.
[0074] If the entire fabric connector 14 is opaque, a window 30 may
be made to view a site through a transparent hollow member. Also,
one or several openings 31 could be made in the fabric connector to
accommodate other sites, or to accommodate body parts such as
fingers, toes, wrists, ankles, elbows, eyes, ears or kneecaps, for
example. A window 30, as well as an opening 31, may be square,
round, "U" or "X" shaped, or any other useful or decorative shape.
Models for right or left hands, for instance, may be made. By
varying the size or shape of a site guard's hollow member 12 and
size, shape, or material of its fabric connector 14, the site guard
10 may accommodate sites on any desired area of the body, such as
infant scalps and extremities.
[0075] There are several embodiments of the fabric connector 14.
Some fabric connectors 14 envelop one or more sites, the hollow
member 12, and the surrounding area; while others comprise one or
several straps including means for affixing 23 the hollow member 12
to the fabric connector 14 and means for closing 20 the fabric
connector 14 so the entire site guard 10 is secured to a patient.
The straps may be simple, such as the elongate fabric connector 14
pictured in FIGS. 1a and 6a, or more complicated such as being made
in an "X" or "Y" shape (not shown). Affixing means 23 includes but
is not limited to a way to fasten a fabric connector 14 such as a
strap to the hollow member 12. Two or more straps together may
secure the site guard 10 onto the patient. Other fabric connectors
are permanently or removably affixed to the inner or outer dome,
sidewalls, or lower edge of a hollow member. Affixing means 23 may
include but is not limited to sewing, gluing, ultrasonic welding,
chemical bonding, or using other means such as Velcro to affix the
hollow member's 12 lower edge 16 onto a fabric connector 14, such
as a cloth or plastic wrap-around dressing. In another embodiment,
the hollow member 12 affixes to the fabric connector 14 by using
gauze, flannel or other soft breathable cloth cut on a bias,
doubled with a pocket the hollow member 12 can slide into.
[0076] Closure means 20 includes but is not limited to tape and
other adhesives such as tape wrap, where fabric is against the skin
and a peel-and-stick tape is on both ends, as well as non-adhesives
such as hook-and-loop fasteners (Velcro.RTM.); Velcro
ONE-STRAPs.RTM.; hook and eye fasteners, ties, pins, clips, hook
and eye fasteners, ultrasonic welding or glue, and other suitable
products. Closure means 20 are not limited to one shape or size;
for instance, Velcro can take any form or shape; circle or
square.
[0077] A fabric connector 10 may also incorporate or be coated with
various agents. As used herein, an "agent" includes but is not
limited to antimicrobial agents such as antifungal, antibacterial,
or antiviral agents; aloe; vitamin E; lotions; burn salves such as
Silvadine, or any other agent. Combinations of these agents may
also be used. The amount of each agent used should be sufficient to
have the desired effect without irritating the skin or have
untoward side effects.
[0078] A preferred embodiment of the fabric connector 14 is two
straps made of latex-free cloth that fit around an area and attach
comfortably to a patient, without being tight or restrictive to
medicine or blood flow. It has stretch and memory to retain its
original shape, to provide a loose fit that stays in place. The
straps attach to each other with some overlap, but do not wrap
around the site in a circumferential manner. The ends of the straps
are rounded, to avoid leaving unnecessary material for patients to
pick at (such superfluous material is often called "dog-eared.")
The preferred fabric connector 14 does not require any other fabric
connector, such as an ace wrap or a cohesive type wrap that adheres
to itself.
[0079] Site guards 10 may be stabilized and made more comfortable
by cushioning the hollow member's base. Such cushioning may be
achieved by affixing various materials to the base, such as cloth,
gauze or Gortex-treated materials, or by flaring or otherwise
altering the shape of the hollow member's base to make it more
stable and comfortable against a patient's skin.
[0080] Other potential uses for this product include bracing or
supporting bone fractures in areas where the use of casts is
difficult or impossible, such as the face. The site guard 10 may be
useful in outpatient or over-the-counter settings, for instance for
a person with a bumped head to purchase to avoid irritating the
bump while sleeping. Also, mammals and other animals may benefit
from the present invention.
[0081] The accompanying drawings illustrate several embodiments of
a site guard indicated by reference numeral 10. As illustrated in
FIG. 1a-c, the site guard 10 is comprised of a hollow member 12 and
a fabric connector 14. FIG. 1a-c illustrate a hollow member 12 that
is structurally simple and functionally elegant. It comprises a
fabric connector 14 and a hollow member 12 having a U-shaped base
13 with a generally planar lower edge 16. The U-shaped base 13 is
joined to sidewalls 18, 19 curved upwardly and inwardly to form a
cover 25 with a open end 15 and an closed end 17. The U-shaped base
13 has a width sufficient to straddle a site 48, for instance a
site including a needle or catheter 48a (as shown in FIGS. 1d-1e),
inserted into a vein of a patient where the site 48 also includes a
loop of tubing 48c, transparent dressing, and tape 48d. The
U-shaped base has a length sufficient to cover the site 48 and a
height sufficient to provide a space between the inside of the
inner dome 24 of the hollow member 12 and the site 48. Another
useful embodiment and method for using the site guard 10 includes
positioning the hollow member 12 on a patient, where the hollow
member 12 has an elongate open end 15 and the U-shaped base 13 is
elongated or split into two legs that may lay flush against the
patient's skin (not shown).
[0082] Hollow members 12 may be of any size so as to accommodate
different sizes of sites 48. For instance, a small site guard 10
has a width of up to about 1.5 inches, a length of up to about 1.5
inches, and a height of up to about 0.5 inch. A large site guard 10
has a width of up to about 2.5 inches, a length of up to about 2.8
inches, and a height of up to about 0.8 inches. Other hollow member
12 dimensions may be useful to protect other sites 48, especially
those sites 48 with equipment such as IV equipment 48a-48d,
extension sets, Statlocks or Veniguards. Smaller hollow members 12
may be used to accommodate neonates or small animals, and larger
hollow members 12 used to accommodate adults or large animals. Both
sizes may be used on patients of any age or animals of any size.
The hollow member 12 size is determined by the area of the site it
encompasses, but is not intended to encompass an entire body or
limb. Its dimensions are limited by the size and shape of the base,
which contacts patients' skin, and the height of the dome, which
protects without becoming unwieldy.
[0083] Once the hollow member's dimensions are set, for example to
the size of the small or large site guards described above, in use
it will stabilize and standardize the size of the loop of tubing
48c used in sites such as IV sites. Stabilizing the loop of tubing
48c decreases IV therapy problems caused by loops that are too wide
or too long. The loop must fit under the hollow member 12 of such
sites 48; while varying sizes of tubing 48b and loops 48c may be
used, they cannot exceed the dimensions set by the hollow member
12.
[0084] Use of the present invention will increase dwell time in
patients by decreasing the mechanical manipulation of, for
instance, a catheter 48a at a site 48 or loop of tubing 48c.
Anecdotal evidence showed catheters 48a protected by site guards
lasted four to five days in pediatric (less than 18 year old)
patients. Accordingly, the site guard 10 can increase dwell time in
patients.
[0085] The hollow member 12 is formed of a plastic material stiff
enough to cushion a site 48 from a blow, and flexible enough such
that the open end 15 can be spread when finger pressure is applied
to the cover. To facilitate spreading of the open end 15 to conform
the hollow member 12 to the site 48 and to avoid gouging the
patient's skin, it is preferred that the open end 15 be outwardly
flared and that the sidewalls 18, 19 be curved at the open end 15
of the hollow member 12 as it joins the U-shaped base 13.
[0086] One suitable material for making the hollow member 12 which
satisfies the above-mentioned specifications is medical grade low
density polyethylene from which a 0.030 inch thick hollow member 12
is manufactured by injection molding and thermoforming. Other
materials and processes, including but not limited to vacuum
molding and thermoforming, may be selected to make a rigid or soft
or transparent site guard 10. For instance, if a site did not
require a flexible hollow member 12, the hollow member 12 could be
thermoformed of a polypropylene material to increase its
transparency.
[0087] For the purpose of visualizing a site 48 through the hollow
member 12 it is preferred that the material comprising the hollow
member be transparent or semi-transparent. Transparency is
important since the site guard 10 not only acts as an enclosure but
also allows visual inspection of the site 48, of the condition of
the skin surface immediately around the site, and, if present, of
needle or catheter 48a and surrounding areas. The fabric connector
14 may complement this transparency by being transparent
itself.
[0088] In every embodiment of the present invention, the site guard
10 may include one or more windows 30 in the fabric connector 14
for viewing the site 48 or to avoid harming sites 48 that would
otherwise be covered by the fabric connector 14; one or more
openings 31 to accommodate digits or other body parts otherwise
covered by the fabric connector 14, or as otherwise desired; one or
more channels 36 or 38 (for example, as shown in FIGS. 3a, 4a, 5a,
5c), in the hollow member 12 to help retain the fabric connector as
placed with the hollow member 12; ventilation holes 40 in the
hollow member 12 to keep the site aerated and otherwise control the
environment inside the hollow member 12; antimicrobial or agents;
and a cushion 27, 28 on the lower edge 16 of the hollow member 12,
in addition to any other accessories indicated or their
equivalents. Also, the outer portion 42b of single 14a or opposing
straps 14a, 14b, or other portions of a fabric connector 14 may be
bifurcated or otherwise splayed; long or short; rounded, flared,
tapered, or otherwise shaped. Splayed fabric connectors 14 may be
particularly useful for accommodating fingers or other body
structures in fastening the site guard 10 to a patient. Site guards
10 may also sport different colors or designs, for example for
decorative or classification purposes.
[0089] As shown in FIGS. 1a-1c, the hollow member 12 may provide
the site with ventilation. Ventilation is desirable for reasons
including but not limited to facilitating an exchange of air to
prevent the formation of moisture vapor. Hollow members 12 may be
made with one or more ventilation holes 40, preferably in its top
and/or sidewalls and preferably its closed end 17. However, a
ventilation hole 40 may be placed anywhere on the hollow member 12,
and the hollow member 12 may be altered (for instance, by texturing
and depressing a means for retaining the fabric connector 14) to
enhance ventilation. A ventilation hole 40 may be made in a variety
of shapes and sizes, including but not limited to circular, oblong,
oblate, elongate, rectangular, square, triangular, or grid-like
(for instance, like a screen); as well as being made with a third
dimensional variation such as rectangular strips turned inward.
Also, a ventilation hole 40 may be covered with a porous material
(not shown), such as a plastic grid, nylon mesh, and the like, to
provide further protection of the site 48 from invasive particulate
or other matter. Alternatively, the site guard 10 may be completely
without a ventilation hole 40.
[0090] A preferred embodiment of the site guard 10 is a fully
ventilated device where the hollow member's 12 lower edge 16 may be
affixed to a fabric connector 14 with an affixing means 23. In one
embodiment, the site guard 10 may include ultrasonically welding a
fabric connector 14 to a hollow member 12, where the hollow
member's 12 lower edge 16 has a flat flange shape. Another
embodiment may entail affixing a polyethylene hollow member 12 to a
polypropylene fabric connector 14 with a cyanoacrylate system.
[0091] As shown in FIGS. 1a-1c, a site guard 10 may be provisioned
with a retainer 36 to retain a fabric connector 14 to help secure
the site guard 10 to a patient. For example, the retainer 36 may be
located in the cover 25 between the open end 15 and closed end 17
of the hollow member 12 and may be a channel formed in the hollow
member 12. The channel may be smooth or grooved or otherwise
textured or shaped to help secure a fabric connector 14 in place.
As defined herein, a retainer 36 for the fabric connector 14
includes but is not limited to a structure equivalent to a channel,
such as guiding hooks or half or whole "belt" loops, or could
include one or more smaller deeper channels within a larger channel
for retaining fabric connectors 14 of varying widths (not
shown).
[0092] As seen in FIG. 1c, the fabric connector 14 comprises two
opposing straps 14a, 14b, each strap having an inner portion 42a
affixed to the lower edge 16 and inner sidewall 18 of the hollow
member 12. An outer portion 42b includes closure means 20 in the
form of a Velcro strip. The dimensions of the opposing straps 14a,
14b of this fabric connector 14 are at least about three inches
long, and at least about one inch wide. Circular and oval top and
side ventilation holes 40 help aerate the site 48. The site guard
10 fabric connector 14 in these illustrations is made of stretch
wrap that fastens to the closure means 20, so the relative
tightness of the fabric connector 14 may be easily adjusted. In
this and several other embodiments of the invention, the site guard
10 may be easily disengaged from the patient by removing part or
all of the fabric connector 14 from the hollow member 12, or by
disengaging the site guard 10 from the patient. The integrity of a
site 48, and if present a site's 48 needle or catheter 48a, loop of
tubing 48c or other accompanying equipment, as well as the
patient's skin, may be inspected, treated or adjusted, and the site
guard 10 easily remounted. By protecting the site 48, while leaving
it readily available for inspection either through the cover 25 or
with the cover removed, the number of IV restarts is reduced. The
reduction in IV starts reduces patient discomfort and lowers
medical costs.
[0093] The illustration in FIG. 1c shows that the hollow member's
12 lower edge 16 may have a means for spreading the weight of the
hollow member 12 across a patient's skin once approximately placed
over a site. Flaring (FIGS. 18a and 18b) or any other modification
of any part of the hollow member 12 that directly contacts the skin
may act as a "cushion" to further protect the patient's skin or
body. The lower edge 16 may be partially cushioned 27 or entirely
cushioned 28. For instance, as shown in FIG. 1c, the inner portions
42a of the fabric connector 14 form a partial cushion 27 of the
lower edge 16 of the hollow member 12. Covering the lower edge 16
in this way comfortably cushions the patient's skin from direct
contact with the lower edge 16. Material to cushion the lower edge
16 of a hollow member 12 may be made of, but is not limited to,
soft porous cloth, gauze, stretch wrap, foam tape, or other
suitable substance. Such material is affixed to the hollow member
through removable or permanent affixing means 23 like Velcro,
sewing, gluing, ultrasonic welding, and any other means for
attaching the fabric connector 14 to the hollow member 12.
Alternatively, a separate cushion 27, 28 may be added to increase
patient comfort. The cushion 27, 28 may completely surround the
base 13 or flange 230 of the hollow member 12, may be U-shaped, may
line only the lower edge 16, or be placed in any other position
that would increase the comfort of the site guard 10 or assist in
cushioning blows to the site guard 10 on a patient. Further,
several layers of cushion 27, 28 may be used with each other.
[0094] FIG. 1d shows a hand with an IV site 48, and FIG. 1e shows
the site guard 10 assembled over the site 48. In FIG. 1d, the loop
48c extends up among the fingers of an IV patient's hand, then
hangs off of the side of the hand. In FIG. 1e, the hollow member 12
controls the size of the loop of tubing 48c, and prevents
unnecessary pulling or other movement of the tubing 48b near the
puncture area 48. Currently, nurses are instructed to loop 48c the
tubing 48b back and secure the tubing with tape 48d. A loop of
tubing 48c that is too wide or long creates problems in IV therapy.
The hollow member's size and shape stabilize and standardize the
size of the loop 48c and tubing 48b used, and thus decrease some IV
therapy problems. Adherence to directions facilitates training
nurses in the use of this invention without criticizing current
practices.
[0095] In use, as shown in FIG. 1e, a site guard's 10 hollow member
12 may conform to one or more sites 48 on a hand 46. The hollow
member 12 may also conform to venipuncture sites 48 on adults and,
on a smaller scale, on infants. The flexibility of the plastic
cushions blows on the hollow member 12 with a gradual resistance
such that the site 48 is protected, the friction joint between hub
and tapered part of hub is not broken, and if present the needle or
catheter 48a is protected from displacement. There is a decreased
chance of snagging the needle or catheter 48a, which gives the
patient a sense of security. Under the protection of the hollow
member 12, tubing 48b and other site apparatus, or an extension set
that allows infusing through the hub about six inches away from the
catheter hub (not shown) rather than directly into the hub on the
patient's skin, is separably connected to the hub of a needle or
catheter 48a. A setup for a particular patient may or may not
employ an extension set. For intermittent use, the hub can be
capped with a locking plug (not shown) and the supply line
disconnected.
[0096] The fabric connector 14 in FIG. 2a is completely separate
from the hollow member 12; in FIGS. 2b and 2c, the fabric connector
14 is affixed to the interior of the hollow member 12. FIG. 2c
shows that the hollow member 12 has affixing means 23 attached to
its inner dome surface 22. In this embodiment, the affixing means
is a hook and loop fastener like Velcro. The fabric connector 14 is
pressed against the closure means 20 located on the inner dome
surface 22 in the hollow member 10 to form a site guard 10 that can
be placed over a site 48. The fabric connector's opposing straps
14a, 14b may be stretched to comfortably secure the hollow member
12 to a site 48, using closure means 20 such as Velcro strips on
the outer portions 42b of the fabric connector 14. A fabric
connector 14 affixed in this way to the hollow member 12
automatically creates a partial cushion 27 on the lower edge
16.
[0097] The site guard 10 embodiment illustrated in FIGS. 3a-c is
similar to that of FIG. 1a-c. For instance, it may include
ventilation holes 40 in the hollow member 12 as described for the
embodiment shown in FIGS. 1a-1c. However, in FIGS. 3a-c the fabric
connector 14 is large enough to cover the entire length and width
of the hollow member 12, and is affixed to the lower edge 16 of the
hollow member 12. The dimensions of the opposing straps 14a, 14b of
this fabric connector 14 are of a length and width sufficient to
accommodate any. To accommodate the site 48, a window 30 is cut out
of the fabric connector 14, as seen in FIG. 3c. The window 30 also
preserves the transparency of the hollow member 12, so the site 48
may be fully viewed through the hollow member 12 at all times. The
window 30 also creates a complete cushion 28 around the entire
lower edge 16 of the hollow member 12 by using the fabric connector
14 as a cushion. Such a cushion may improve the stability of a site
guard 10 and create a more comfortable fit on the patient's skin.
As in the other examples, the opposing straps of the fabric
connector 14a, 14b may be stretched to secure the site guard 10
over the site 48 and closed with closure means 20.
[0098] FIGS. 4a-c shows another embodiment of the invention, where
the fabric connector 14 is affixed to the outer side walls 19 of
the hollow member 12 and may cover the hollow member 12 only a
little or not at all. A window 30 allows for viewing of a site 48.
The openings 31 in the opposing straps 14a, 14b of the fabric
connectors may accommodate other sites or body parts, and closure
means 20 close the straps to secure the site guard 10 over a
desired site 48. Additionally, the fabric connector 14 may be
transparent. One strap 14b is bifurcated to allow for greater
flexibility in adjusting the fabric connector 14.
[0099] FIG. 5a illustrates a plan view of the top side of the site
guard of the present invention, where the fabric connector 14 may
be removably affixed to the outer dome 26 and outer sidewall 19
surfaces of the hollow member 12. The applicants demonstrate the
use of a Velcro ONE-WRAP strap as the fabric connector 14, where
Velcro is affixed to the outer dome 26 surface and sidewalls 19 of
the hollow member 12. The remainder of the strap is a fabric with a
smooth surface 32 and a textured surface 34 that fastens to the
Velcro strip, as shown in use in FIG. 5d. The hollow member 12 may
thus be secured over a site 48 simply by fastening the textured
surface 34 to the Velcro strip. In use, as shown in FIG. 5d, a site
guard's 10 hollow member 12 may conform to one or more sites 48 on
a hand 46 or to venipuncture sites 48 on adults and, on a smaller
scale, on infants.
[0100] FIG. 6a illustrates an embodiment of the invention where the
fabric connector 14 is not permanently affixed to the hollow member
12. FIG. 6b shows the assembly of the site guard 10 over a site 48
on a patient's hand 46. First, a hollow member 12, with or without
a cushioned base 27, 28, is placed over a site 48 such that the
site and its accompanying tubing 48b and other items fit under the
hollow member 12. Then a fabric connector 14 with opposing straps
14a, 14b is placed over the hollow member 12 and secured to the
hand with closure means 20 on the outer portions 42b. A channel 38
in the hollow member 12 guides the fabric connector 14 to keep it
from becoming displaced. A window 30 in the fabric connector 14
positions over the transparent hollow member 12 so the site 48 can
be easily viewed. An additional Velcro strip may be placed directly
on the outer surface of the hollow member 12 may be used to more
fully secure the fabric connector 14 to the hollow member 12.
[0101] FIGS. 7a-c illustrate another embodiment of the present
invention. FIG. 7a shows a completely closed hollow member 12 with
a round base and lower edge 16, and a separate fabric connector 14
made of a delicate white tubular mesh 14c. The hollow member 12 may
include ventilation holes 40 as described for the embodiment shown
in FIGS. 1a-1c. The fabric connector 14c could be made of any
tubular material capable of enveloping a patient's entire hand 46,
or any other body part as needed. If a site 48 does not include IV
tubing 48b or other apparatus that requires an open end to the
hollow member 12, the hollow member 12 may still have one or more
open ends, or be fully closed as shown here. The lightweight mesh
14c must be tight enough to secure the guard but not so tight as to
cause patient discomfort. As seen in FIG. 7b, where the tubular
mesh 14c is turned inside-out, the tubular mesh 14c has affixing
means 23 that will match up with affixing means 23 on the outer
portion of the hollow member 12 (FIG. 7a), to affix the fabric
connector as seen in FIG. 7c. In use, as shown in FIG. 7c, a site
guard's 10 hollow member 12 may conform to one or more sites 48 on
a hand 46 or to venipuncture sites 48 on adults and, on a smaller
scale, on infants.
[0102] FIG. 7c shows the fully assembled site guard 10, where the
fabric connector 14c completely envelops the hollow member 12 and
surrounding area of the patient's hand and wrist. Other means for
affixing 23 the fabric connector 14c to the hollow member 12 may
also be used. Varying grades of mesh may be used, with the size of
the mesh and weight of the material varying with the degree of
support needed and the sensitivity of the patient's skin. A window
30 could be made in the fabric connector 14 if the mesh was too
dense to allow for viewing of the site. This embodiment provides an
exceptionally useful means for securing a hollow member 12 to burn
patients, since it is very lightweight, easily removed by cutting,
and less dense than fabric connectors 14 comprised of straps. This
embodiment of the site guard 10 slides easily under covers, loose
clothing, and various wraps, where it can be worn (for instance by
IV patients between treatments) without detection and with
discretion to protect the patient's right to privacy regarding
treatment and illness. The preferred embodiment of this type of
site guard 10 is a fabric connector 14 of tubular mesh 14c and of
the size to cover a patient's hand and portions of the patient's
fingers and wrist. The tubular mesh 14c may have different
diameters openings 31 to comfortably fit varying sizes of wrists
and fingers. The mesh covering the fingers may be cut to various
lengths; in the picture, the mesh covering the thumb and middle
finger is shorter than the mesh covering the remaining fingers.
Fabric connectors 14 may be made to be aesthetically pleasing. In
FIG. 7c, a colored stripe 14e runs along the tubular mesh 14c from
the wrist to the fingers.
[0103] Other embodiments of this particular version could include
having a 1/2 length tubule of burn netting permanently or removably
attached to the lower edge 16 of the hollow member 12. The fabric
connector 14 could be made of stretch wrap or of some more rigid
cloth, such as the type that could be comfortably opened, closed
and adjusted with criss-cross ties like corset strings. Also, a
fabric connector 14 could be opened and attached to the base 16 or
sidewalls 18, 19 of the hollow member 12, creating an embodiment
similar to FIGS. 1a, 3a and 4a, but where the straps are continuous
(not shown).
[0104] The embodiment shown in FIG. 7c may also include a partial
or total cushion (not shown). In this embodiment, uses for a
partial 27 or total cushion 28, other than those previously
discussed, include monitoring and helping control the moisture
inside the hollow member 12. Although this function is useful in
any of the embodiments, it is especially useful for an embodiment
including a completely closed hollow member 12 or a hollow member
12 fully enveloped by a fabric connector as is shown in FIG. 7c.
Site guard cushions 27, 28 may be removably or permanently affixed
to the hollow member 12, depending on the type of material the
cushion is made from, whether it is part of the fabric connector
14, and the perceived needs of the applicants.
[0105] The site guard can also be affixed to an arm board of
various lengths using the connectors presented herein. Such arm
boards are frequently used in pediatric patients and may run from
the hand to the wrist or from the hand to the elbow.
[0106] In another embodiment (FIG. 8), the fabric connector 14
comprises a single strap made from stretch fabric or other
stretchable material. The fabric connector 14 is attached to the
top of the hollow member 12. The fabric connector 14 wraps around
the desired body part and attaches to an adhesive 100 or Velcro
located on the top of the hollow member 12. The tension created by
the fabric connector 14 helps to hold the site guard 10 in place.
Prior to and when not in use, the adhesive 100 is covered by a
strip 102 that can be removed without destroying the adhesive
properties of the adhesive. Alternatively, the fabric connector 14
may comprise a bifurcated or double strip that is attached to
either the inner 18 or outer 19 sidewall.
[0107] In other embodiments (FIGS. 9-13), the fabric connector 14
comprises a single strap with a plurality of holes 110. In use, one
of these holes 110 mates with a tab 115 located somewhere on the
site guard 10. These embodiments enable the site guard 10 to be
used on body parts or patients of various sizes by mating the
appropriate hole 110 with the tab 115. Furthermore, the fabric
connector 14 can be made of a stretchable material to ensure an
even better fit and alignment of the site guard 10.
[0108] In FIG. 9, the fabric connector 14 includes a plurality of
holes 110. The lower portion of hollow member 12 includes a strip
of fabric 120 to which the fabric connector 14 is stitched or
otherwise attached. In use the fabric connector 14 wraps around the
desired body part and one of the holes 110 mates with the tab 115
to securely, but not too tightly, secure the site guard 10 to the
patient.
[0109] FIGS. 10a-c, show an embodiment similar to the one shown in
FIG. 9. In use, the fabric connector 14 includes a plurality of
holes 110 that mate with a tab 115 on the hollow member 12.
Additionally, the fabric connector 14 includes a doubled-over
portion 125 on its inner portion 42a. The inner portion 42a is
attached to the hollow member 12 by inserting the fabric connector
14 into a slot 130 in the hollow member 12 (FIG. 10b). The
doubled-over portion 125 prevents the fabric connector 14 from
being pulled completely through the slot 130, as shown in FIG. 10c.
Alternatively, the doubled-over portion can be formed after the
fabric connector 14 has been inserted into slot 130 and formed so
that it wraps around the lower portion of the hollow connector 12,
thereby forming a loop around the lower portion.
[0110] FIG. 11 also shows an embodiment similar to the one shown in
FIG. 9. In use, the fabric connector 14 includes a plurality of
holes 110 that mate with a tab 115. The hollow member 12 includes a
side extension 135 attached to the side of the hollow member 12
opposite the side to which the fabric connector 14 is attached. The
tab 115 is attached to the side extension.
[0111] FIGS. 12a and 12b show an embodiment wherein in use, the
plurality of holes 110 and the tab 145 are located on the fabric
connector 14. The tab 145 is affixed to the inner portion 42a of
the fabric connector 14. The hollow member 12 includes a bar 141.
The fabric connector 14 passes under the bar 141, thereby attaching
it to the hollow member 12. The bar 141 may be integral to the
hollow member 12 or consist of a separate piece that is attached to
the hollow member 12. Alternatively, fabric connector 14 may
comprise a loop formed by connecting the inner portion 42a to the
outer portion 42b after the fabric connector passes under bar 141.
The inner 42a and outer 42b portions may be connected in an
overlapping or side-by-side manner.
[0112] FIG. 13 shows an embodiment similar to the one shown in FIG.
9. In use, the fabric connector 14 includes a plurality of holes
110 that mate with a tab 115. The inner portion 42a of the fabric
connector 14 includes a connector hole 150 that mates with a second
a second tab 115b on the hollow member 12. In use, generally, the
connector hole 150 is mated with the second tab 115b before one of
the plurality of holes 110 mated with the first tab 115.
[0113] In any of the embodiments shown in FIGS. 9-13, the tab 115
can be, but is not limited to, an adhesive tab or a button tab.
Alternatively, the tab 115 may be, but is not limited to, die cut
or kiss cut from the element of the site guard 10 to which it is
attached. Furthermore, the tab 115 can be of any size and shape
that can mate with any of the holes 110.
[0114] In other embodiments (FIGS. 14-16), adhesive is used to
affix the fabric connector 14 to the hollow member 12. In the
embodiment shown in FIGS. 14a and 14b, the site guard 10 further
includes a support 160. This support 160 is generally comprised of,
but not limited to, a foam, such as a closed cell foam and may be
manufactured by a molding process. The lower edge 16 of the hollow
member 12 is attached to the support 160. Integrated with the
support 160 is the fabric connector 14. In this embodiment, the
fabric connector 14 is made from the same foam material as the
support 160 and can comprise a plurality of minor strips 165.
Furthermore, the support 160 includes at least one adhesive strip
161 or Velcro, or other closure means 20, which is generally equal
in number the minor strips 165. In use, the fabric connector 14 (or
minor strips 165) wrap around the desired body part and are affixed
to the hollow member 12 using the adhesive strips 161, Velcro, or
other closure means 20.
[0115] The embodiment shown in FIG. 15 also includes a support 160
with at least one adhesive strip 161, or other closure means 20,
and a fabric connector 14. The fabric connector may comprise a
plurality of minor strips 165. Additionally, the support 160
includes a base flange 162 and a plurality of base tabs 175a, 175b
that each include adhesive pads 176, or other affixing means 23.
The base flange 162 helps to spread the pressure from the hollow
member 12 over a greater area, thus providing more comfort for the
patient. The base tabs 175a, 175b, or other affixing means 23, are
used to attach the hollow member 12 to the support 160. During
assembly, the hollow member 12 is placed on the support 160. The
support tabs 175 are bent upward to engage the inner dome 24 of the
hollow member 12 wherein the adhesive pad 176 affixes the support
tab 175 to the hollow member 12. Support tab 175a is shown as it
would appear prior to being affixed to the hollow member 12, while
support tabs 175b are shown after being affixed to hollow member
12. Additionally, the minor strips 165 each include a plurality of
indentations 170 on one or both sides of the minor strips 165.
These indentations 170 provide reference points for cutting,
trimming or ripping the minor strips 165 down to the desired length
to fit individual patients or body types. The support tabs 175a can
be attached to hollow member 12 using adhesive, stitching, welding
or any other affixing means 23.
[0116] The embodiment shown in FIG. 16 shows an embodiment similar
to the one shown in FIG. 15. It includes a support 160 which
includes a support flange 162 and a plurality of support tabs 175a,
175b each including an adhesive pad 176. The support 160 is affixed
to the hollow member 12 using the support tabs 175a, 175b as
previously described. The support tabs 175a can be attached to
hollow member 12 using adhesive, stitching, welding or any other
means for affixing 23. This embodiment also includes an adhesive
strip 161 (a plurality of adhesive strips may also be used), and a
fabric connector 14. The fabric connector 14 comprises a plurality
of perforations 180 (only one is shown here) located along its
length. It further includes minor strips 165 intermittently
connected together at connection points 185. This allows the minor
strips 165 to be manufactured from a single piece of material.
During use, the minor strips 165 can either be used connected
together, or can be separated from each other at the connection
points 185. Further, the minor strips 165 may be partially
separated from each other to accommodate digits or other body
parts. This allows greater flexibility when trying to attach the
site guard 10 in the vicinity of a limb or joint and allows
ambidextrous use on any sized patient on either hand, forearm,
upper arm, leg, or other body part.
[0117] In another embodiment shown in FIGS. 17a and 17b, the fabric
connector 14 can further comprise a utility strap 200. The utility
strap 200 is a U-shaped strap that can be used to further secure
the hollow member 12 to its desired location. It also includes at
least one adhesive patch 210, or other affixing means 23, that is
used to affix the utility strap 200 to the site guard 10. The
utility strap 200 is particularly useful in securing the hollow
member 12 to an irregularly shaped area or in the vicinity of a
joint or appendage. FIG. 17b shows the utility strap 200 as it may
be used to helps secure the hollow member 12 to the back of a hand.
The utility strap 200 can be made from any of the same materials
used for the fabric connector 14.
[0118] FIGS. 18a and 18b show an alternative embodiment of the
hollow member 12. In this embodiment, the hollow member 12
comprises a member flange 230 attached to its lower edge 16. This
member flange 230 helps distribute the pressure on the patient
caused by the hollow member 12, thereby making the site guard more
comfortable for the patient. The member flange 230 may be partially
cushioned 27 or entirely cushioned 28 with the cushion 27, 28
taking any form and being of any material as described above, and
particular in relation to FIG. 1c.
[0119] In an alternative embodiment depicted in FIG. 19, the fabric
connector 14 comprises at least two openings 31 for ambidextrously
accommodating one or more digits. The site guard 10 may include
fabric connector 14 having a first and a second openings 31a and
31b, respectively, wherein the first opening 31a receives the right
thumb and the second opening 31b receives the left thumb. Such an
embodiment permits the use of one site guard 10 on either the left
hand or the right hand, thereby foregoing the need to supply
separate site guards 10 for each hand. The fabric connector 14 may
be offset to one side of the hollow member 12 with both first and
second openings 31a and 31b on the offset side as seen in FIG. 19
or may be centered with openings 31 in the fabric connector 14 on
each side of the hollow member 12 as depicted in FIGS. 4a and 4c.
Different sizes of the site guard 10 may accommodate different
sizes of various body parts. As discussed above, any type of
closure means 20 may secure the fabric connector 14 and the hollow
member 12 to the patient.
[0120] FIGS. 21a-e depict various sizes that may be utilized for
the embodiment depicted in FIG. 19 and discussed herein. Sizes may
include extra-small (XS), small (S), medium (M), large (L), and arm
(for the wrist, forearm, or upperarm). Other sizes may also be
included and may also accommodate other body parts. A hand chart
300 may be utilized to measure the patient's hand to determine the
size to be used. FIG. 22 depicts the hand chart 300 including four
sections: XS, S, M, and L. The hand chart 300 is used by placing
the hand on the hand chart 300. In one embodiment, the width of the
hand is measured from the index finger to the pinkie finger. A hand
that is measured to approximately 3.125 inches or less falls in the
extra small range; a hand that is measured between approximately
3.125 inches to approximately 4.25 inches falls in the small range;
a hand that is measured between approximately 4.25 inches to
approximately 5.0 inches falls in the medium range; and a hand that
is measured between approximately 5.0 inches to approximately 5.75
inches falls in the large range. The skilled artisan will recognize
that these ranges may vary with different types of site guards
10.
[0121] In any of the embodiments described above, the fabric
connector 14 may comprise an extender 166 shown in FIG. 20 to be
used with large or obese patients or with a large body part. The
extender 166 comprises any of the fabric connectors 14 described
herein and provides an extension thereto and may be attached to the
fabric connector 14 with affixing means 23 as described above. In
one embodiment the extender 166 is 12 inches long with Velcro every
two inches to affix to the patient at adjustable lengths.
Perforations 180 or indentations 170 may be used to cut, rip or
tear the extender 166 to fit individual patients or body types.
[0122] Although the invention has been described with respect to
specific embodiments, it should be appreciated that other
embodiments utilizing the concept of the present invention are
possible without departing from the scope of the invention. The
invention, for example, is not intended to be limited to the
specific materials discussed and exemplified and disclosed in these
embodiments; rather the invention is defined by the claims and the
equivalents thereof.
* * * * *