U.S. patent application number 14/252742 was filed with the patent office on 2014-08-07 for apparatus and method for sterilization.
The applicant listed for this patent is John Krug, William Reese. Invention is credited to John Krug, William Reese.
Application Number | 20140219865 14/252742 |
Document ID | / |
Family ID | 44560183 |
Filed Date | 2014-08-07 |
United States Patent
Application |
20140219865 |
Kind Code |
A1 |
Reese; William ; et
al. |
August 7, 2014 |
APPARATUS AND METHOD FOR STERILIZATION
Abstract
The present invention provides an apparatus and method for
disinfecting a target area of a patient's body, such as an arm, leg
or a chest, in a pre-surgical environment. The apparatus and method
disclosed herein further provides for maintaining the target area
of the patient's body in an aseptic condition while transporting
the patient to and into the surgery room. The most preferred
embodiments of the present invention contemplate the use of one or
more sterile layers (e.g., sterilized bags or the like) that are
used to enclose the target area of the patient's body coupled with
a sterile substance delivery mechanism that disinfects the target
area and also maintains the target area in an aseptic
condition.
Inventors: |
Reese; William; (Gilbert,
AZ) ; Krug; John; (Orange, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Reese; William
Krug; John |
Gilbert
Orange |
AZ
CA |
US
US |
|
|
Family ID: |
44560183 |
Appl. No.: |
14/252742 |
Filed: |
April 14, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
12722459 |
Mar 11, 2010 |
8697000 |
|
|
14252742 |
|
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Current U.S.
Class: |
422/28 ;
422/292 |
Current CPC
Class: |
A61B 46/00 20160201;
A61B 46/30 20160201; A61B 90/40 20160201; A61L 2/0082 20130101;
A61B 46/27 20160201; A61F 2013/00174 20130101; A61F 2013/00536
20130101; A61L 2/0088 20130101 |
Class at
Publication: |
422/28 ;
422/292 |
International
Class: |
A61L 2/00 20060101
A61L002/00 |
Claims
1. An apparatus comprising: a body portion, said body portion
comprising and defining: an interior space; a longitudinal axis;
and a circumference; a strap affixed to said body portion, said
strap comprising at least one adhesive zone; a first perforation
formed in said body portion, said first perforation being
positioned substantially parallel to said longitudinal axis; and a
second perforation formed in said body portion, said second
perforation being substantially perpendicular to said first
perforation and being positioned around said circumference.
2. The apparatus of claim 1 further comprising at least one tab
affixed to said body portion.
3. The apparatus of claim 1 further comprising a delivery system
disposed within interior space of said body portion.
4. The apparatus of claim 3 wherein said delivery system comprises
at least one length of tubing and at least one aeration
mechanism.
5. The apparatus of claim 4 wherein said at least one aeration
mechanism comprises an air stone and wherein a quantity of a
disinfectant is introduced into said interior space of said body
portion via said at least one length of tubing and said air
stone.
20. A method comprising the steps of: enclosing a target area of a
patient's body within an apparatus, said apparatus comprising: an
inner bag, said inner bag comprising an interior surface, an
annular space, an exterior surface, and an interior space, said
interior space comprising said annular space and said interior
surface; said interior space and exterior surface being selectively
configured to be sterile; an outer bag, said outer bag comprising
an interior surface, an annular space, an exterior surface, and an
interior space, said interior space comprising said annular space
and said interior surface; said interior space being selectively
configured to be sterile; a delivery mechanism selectively
configured to deliver at least one sterile substance selected from
a group consisting of an aseptic and a disinfectant.
21. The method of claim 20 further comprising the steps of:
disposing said inner bag within said interior space of said outer
bag; contacting a cuff of said inner bag with a contact-portion of
said patient's body, said contact-portion of said patient's body
adjacent and not coextensive with said target area of said
patient's body, said cuff comprising a hem and at least one
body-fastener, said at least one body-fastener selectively
configured to detachably affix said cuff to said contact-portion of
said patient's body, said hem extending beyond an cuff-portion of
said outer bag, said hem being folded back over said
extended-portion of said outer bag and forming said cuff, said cuff
being substantially U-shaped, said cuff partially surrounding said
extended-portion of said outer bag; connecting a first end of at
least one length of tubing with at least one pump, said at least
one length of tubing being selectively configured to transport at
least one sterile substance, said at least one sterile substance
being selected from the group consisting of air, at least one
disinfectant, at least one antiseptic, at least one vapor, at least
one fluid, at least one liquid, and at least one gas; said at least
one pump being selectively configured to introduce into and suck
from said interior surface of said inner bag at least one element
selected from the group consisting of disinfectants, antiseptics,
air, gases, vapors, mists, liquids, fluids, moistures, foams, gels,
nanoparticles, particles, molecules, pressure, negative pressure,
positive pressure, ambient pressure, equilibrium pressure, dynamic
pressure, vapor pressure, stagnation pressure, surface pressure,
and combinations thereof; inserting a second end of said at least
one length of tubing through at least one flow port; inserting said
second end of said at least one length of tubing into at least one
of the elements selected from the group consisting of said interior
space of said inner bag and said interior space of said outer bag;
pumping at least one sterile substance into at least one of the
elements selected from the group consisting of said interior space
of said inner bag and said interior space of said outer bag, said
at least one sterile substance selected from the group consisting
of aseptic and disinfectants; and contacting said sterile substance
with a target area of said patient's body.
22. The method of claim 20 further comprising the steps of: forming
a mixture of said sterile substance and an amount of air, said
mixture comprising an amount of said sterile substance and an
amount of air; contacting said mixture with at least one aerating
mechanism, said at least one aerating mechanism being selectively
configured to convert said mixture an amount of foam; contacting
said target area of said patient's body with said foam; and
detaching said outer bag from said inner bag.
23. The method of claim 22, wherein the step of contacting said
target area of said patient's body with said foam further comprises
the step of disinfecting said target area of body patient's body,
wherein said target area of said patient's body comprises a surface
area of said patient's body.
24. The method of step 20 further comprising the step of inserting
at least one target area of a patient's body through an orifice of
said inner bag, said at least one target area being selected from
the group consisting of at least one limb, at least one arm, at
least one elbow, at least one finger, at least one toe, at least
one ear, at least one genital, at least one buttock, at least one
nose, at least one chin, at least one forehead, at least one wrist,
at least one palm, at least one hand, at least one leg, at least
one knee, at least one chest, at least one torso, at least one
shoulder, at least one back, at least one head, at least one face,
at least one neck, and at least one foot.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] This patent application is a divisional of U.S. patent
application Ser. No. 12/722,459, which application was filed on
Mar. 11, 2010, and which application is currently pending, and
which application is incorporated herein by reference.
BACKGROUND OF THE INVENTION
[0002] 1. Technical Field
[0003] The present invention relates generally to medical
procedures and relates more specifically to a sterilization
procedure that may be performed in a pre-operative environment
using a unique garment or dressing.
[0004] 2. Background Art
[0005] Healthcare professionals recognize the importance of
preparing patients for medical procedures by disinfecting the
target area where the procedure is to be performed with a topical
aseptic preparation, such as chlorhexidine gluconate or rubbing
alcohol. During surgery, in order to perform certain procedures,
healthcare professionals are frequently required to penetrate or
open up one or more areas of a patient's body, for example, the
skin of the chest area. If the target area of the patient's body
has not been properly sanitized, breaking through the surface layer
of the patient's body may increase the risk that the patient will
become infected. For example, if healthcare professionals opened up
a patient's chest area for open heart surgery but neglected to
aseptically prepare the chest area prior to making incisions, then
any bacteria, viruses, or other organisms that were originally
located on or near the surface of the skin and in proximity to the
incision or entry point may migrate to and enter the open wound,
thereby infecting the patient.
[0006] Typically, a surgical patient is prepared for surgery by
administering a 3 to 10 minute scrubbing of the target surgical
area with a soap solution, followed by painting the target area
with a water-soluble antiseptic solution in the operating room or
surgical theater. This pre-surgical preparation of the target area
has improved with the use of antiseptics that require only
surficial contact with the skin. Delivery devices have also been
developed to apply these antiseptic solutions by sponging,
brushing, spraying, and/or painting the target area once the
patient arrives in the operating room. The current methods of
sterilization, however, do not address, among other things, the
increased risk of transferring infectious disease between patients,
healthcare professionals and others that may occur prior to the
surgical preparation of the target area in the operating room.
[0007] The current pre-surgical disinfectant methods all present
certain drawbacks, which may be broadly categorized into four
specific areas of concern: increasing the time that the patient
spends in the operating room; increasing the length of time that
patient is under anesthesia; increasing the risk of injury to
operating room professionals while moving and/or holding the
patient in order to sterilize the target area; and increasing the
risk of transferring an infection to or from the patient during the
pre-operative period.
[0008] Using the current methods for preparing patients for
surgery, precious time that could be spent performing the operation
may be spent on disinfecting the surgical surface area of the
patient's body, which is usually an area of skin. Additionally,
even if the sterilization of the target area is accomplished in a
pre-operative environment, the target area of the patient's body
may be exposed to the air or other contaminants and can become
unsterile. If the patient's clothing or the target area has become
unsterile during the course of transportation, there is a risk that
the target area of the patient's body could be subject to infection
once the procedure begins.
[0009] Another risk posed by current methods is they generally
increase the time that a patient is under anesthesia, which is less
than ideal since extended exposure to anesthesia may pose some risk
for the patient. Further, the common practice of performing the
surgical preparation in the operating room using current methods
typically requires operating room personnel to lift, hold, and/or
move patients since the patient has usually been anesthetized and
can no longer control the movement of their body. This may cause
physical stress on the personnel performing the pre-operative
sterilization procedure and may require additional time from
surgeons, anesthesiologists, surgical nurses, and technicians.
Accordingly, without improvements in the current process for
preparing a patient for surgery, the costs and risks associated
with disinfecting the target area of the patient's body associated
with pre-operative sterilization will continue to be measurably
higher than desired.
BRIEF SUMMARY OF THE INVENTION
[0010] The present invention provides an apparatus and method for
disinfecting a target area of a patient's body, such as an arm, leg
or a chest, in a pre-surgical environment. The apparatus and method
disclosed herein further provides for maintaining the target area
of the patient's body in an aseptic condition while transporting
the patient to and into the surgery room. The most preferred
embodiments of the present invention contemplate the use of one or
more sterile layers (e.g., sterilized bags or the like) that are
used to enclose the target area of the patient's body coupled with
a sterile substance delivery mechanism that disinfects the target
area and also maintains the target area in an aseptic condition.
The most preferred embodiments of the present invention comprise a
single-layer disposable garment or an inner bag nested inside an
outer bag with a sterilization material being introduced into the
inner bag, thereby disinfecting the target area. Once the patient
has been transported into the operating room, the healthcare
professional can remove the disposable garment or the outer bag,
and then expose the target area for the selected procedure. Since
the target area has been disinfected and also maintained in an
aseptic condition, the healthcare professional can immediately
begin to perform a selected procedure on the patient without having
to spend additional time in the operating room to disinfect the
target area of the patient's body that will undergo the selected
procedure.
BRIEF DESCRIPTION OF THE FIGURES
[0011] The preferred embodiments of the present invention will
hereinafter be described in conjunction with the appended drawings,
wherein like designations denote like elements, and:
[0012] FIG. 1 is a perspective view of the apparatus according
deployed in conjunction with a patient in accordance with a
preferred exemplary embodiment of the present invention;
[0013] FIG. 2 is a cross-sectional view of inner bag and outer bag
of the apparatus of FIG. 1 and FIG. 3;
[0014] FIG. 3 is a bottom view of inner bag and outer bag of the
apparatus after outer bag has been removed from inner bag;
[0015] FIG. 4 is a schematic diagram of the various components of
an apparatus used for a method of sterilization in accordance with
a preferred embodiment of the present invention;
[0016] FIG. 5 is a flow chart of a method of using an apparatus for
sterilization in accordance with a preferred embodiment of the
present invention;
[0017] FIG. 6 is a schematic drawing of a disposable garment top
for use in sterilization activities in accordance with an
alternative preferred embodiment of the present invention;
[0018] FIG. 7 is a schematic drawing of a disposable garment bottom
for use in sterilization activities in accordance with an
alternative preferred embodiment of the present invention;
[0019] FIG. 8 is a schematic drawing of a disposable garment top
for use in sterilization activities in accordance with an
alternative preferred embodiment of the present invention;
[0020] FIG. 9 is a schematic drawing of a disposable garment bottom
for use in sterilization activities in accordance with an
alternative preferred embodiment of the present invention;
[0021] FIG. 10 is a schematic drawing of a disposable garment top
with closure mechanisms for use in sterilization activities in
accordance with an alternative preferred embodiment of the present
invention;
[0022] FIG. 11 is a schematic drawing of a disposable garment
bottom with tab mechanisms for use in sterilization in accordance
with an alternative preferred embodiment of the present
invention;
[0023] FIG. 12 is a schematic drawing of a disposable garment
bottom with adhesive positioned for use in sterilization in
accordance with an alternative preferred embodiment of the present
invention; and
[0024] FIG. 13 is a schematic diagram of an apparatus for use in
sterilization activities in accordance with an alternative
preferred embodiment of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0025] Referring now to FIG. 1, an apparatus 27 in accordance with
a preferred embodiment of the present invention comprises: an inner
bag 10; an outer bag 8; and a delivery mechanism 51. The delivery
mechanism 51 is selectively configured to deliver one or more
sterile substances 70 to the interior space 38 of inner bag 10.
Sterile substances comprise aseptics and disinfectants. Inner bag
10 comprises an interior surface 11, an annular space 37, an
exterior surface 12, and an interior space 38.
[0026] Interior space 38 comprises an annular space 37 within inner
bag 10 and interior surface of inner bag 10. Outer bag 8 comprises
an interior surface 61, an annular space 59, an exterior surface 9,
and an interior space 60. Interior space 60 of outer bag 8
comprises annular space 59 and interior surface 11.
[0027] Sterile substance 70 may be any type of material considered
to be a disinfectant (or disinfectants), an aseptic (or aseptics),
or a combination of one or more disinfectants with one or more
aseptics. For purposed of the present invention, a "disinfectant"
may be considered to be any substance or material that is generally
effective for inactivating bacteria, viruses, or other non-sterile
organisms. For purposed of the present invention, an "aseptic" may
be considered to be any substance or material that lacks bacteria,
viruses, or other non-sterile organisms (or bacteria, viruses, and
other non-sterile organisms that are active or capable of being
activated) but does not necessarily function to destroy bacteria,
viruses, or other non-sterile organisms.
[0028] Apparatus 27 refers to an apparatus for applying a dressing
that surrounds a target area 14 on a patient's body 13 in which the
dressing provides a protective barrier from non-sterile
contaminants. In the preferred embodiments of the present
invention, one or more inner bags 10 are generally disposed or
"nested" inside one or more outer bags 8. In the most preferred
embodiments, one inner bag 10 is nested inside an outer bag 10.
However, those skilled in the art will appreciate that the present
invention also contemplates other embodiments such as multiple
inner bags 10 that are nested inside an outer bag 8 or a scenario
where more than one inner bag 10, with each inner bag being at
least partially surrounded by an outer bag 8, have been applied to
the same patient, in one or more areas to cover or enclose one or
more target areas.
[0029] In the most preferred embodiments of the present invention,
inner bag 10 of apparatus 27 comprises a sterile interior space 38
and a sterile exterior 12. In the most preferred embodiments, inner
bag 10 and outer bag 8 are mainly constructed from transparent
material 67, such as plastic. The use of an inner bag 10 and an
outer bag 8 constructed of transparent material 67 allows the
healthcare provider and the patient to see the target area 14 of
patient's body 13, which is useful while inner bag 10 and outer bag
8 are being applied to patient's body 13. Additionally, the
transparent nature of the material allows for monitoring of the
target area while the patient is being transported from the
pre-operative environment to the location where the selected
procedure will be performed.
[0030] In other preferred embodiments of the present invention,
inner bag 10 and outer bag 8 could be constructed from translucent
material, substantially transparent material, and substantially
translucent material. Alternatively, in certain embodiments of the
present invention, where visibility of the target area is not
required, opaque material may be used in the construction of inner
bag 10 and outer bag 10. In the most preferred embodiments of the
present invention, inner bag 10 is nested inside outer bag 8 at the
time of manufacture and inner bag 10 and outer bag 8 come
pre-packaged in a sterile package as a single device.
[0031] While not preferred, other embodiments of the present
invention contemplate an inner bag 10 and an outer bag 8 that come
in separate, sterile packages that are combined at the point of
application to the target area. Yet even other embodiments of the
invention contemplate an inner bag 10 and an outer bag 8 that is
are sterilized at the facility where they will be deployed by the
healthcare professional prior to application to a patient in the
target environment. In this embodiment, the health care
professional would then nest inner bag 10 inside outer bag 8.
[0032] In the most preferred embodiments, interior space 38 of
inner bag 10 is sterile because interior space 38 of inner bag 10
will cover and/or surround a target area 14 of a patient's body 13;
in the most preferred embodiments, the exterior 12 of inner bag 10
will also be sterile because outer bag 8 will be removed in the
surgical room (or just prior to entering the and inner surface of
outer bag 8.) Additionally, in the most preferred embodiments,
interior surface 61 of outer bag 8 has been sterilized because
interior surface 61 of outer bag 8 contacts (or comes near to
contacting) exterior 12 of inner bag 10.
[0033] In the most preferred embodiments of the present invention,
the user can attach cuff 30 of inner bag to a target area 14, that
is, a surface area on the patient's body that needs to be
sterilized or disinfected. Generally, target area 14 will be
accessed by the surgeon just prior to performing the scheduled
procedure, thus it is often advantageous to disinfectant target
area 14 in a pre-surgical room. The apparatus comprises inner bag,
outer bag, and multiple fasteners. In the most preferred
embodiments these fasteners are selectively removable, selectively
positionable, and selectively repositionable. In the most preferred
embodiments there will be at least one adhesive mechanism, such as
a body-fastener 58 and a bag-fastener 40.
[0034] Body-fastener 40 generally refers to an adhesive zone or
adhesive mechanism that allows the user to temporarily attach cuff
30 of inner bag 10 to a contact-portion of the patient's body. In
the most preferred embodiments, if the user of the apparatus wanted
to slide inner bag 10 and outer bag 8 over the patient's foot, the
medical worker could then temporarily affix cuff 30 of inner bag 10
to the knee of the patient, which could be termed the
contact-portion of the patient's body. In this embodiment, the
patient could be scheduled to undergo foot surgery and the
contact-portion, which is the knee, of the patient's body does not
need to be disinfected since the surgeon would not have to open up
the knee. However, the contact-portion of the patient's body is
generally an area on the patient's body in which the medical
professional can fasten the body-fastener of inner bag (or outer
bag in some embodiments) to the patient's body. Generally, the
target area, that is the area of the patient's body that needs to
be disinfected prior to surgery, will be adjacent to the
contact-portion of the patient's body.
[0035] In certain preferred embodiments of the present invention,
the body-fastener is a strap with a selectively repositionable hook
and loop fastener (e.g. a strap with a Velcro.RTM. fastener) and is
similar to the type of strap that is places around the patient's
arm during a blood pressure examination. When measuring the
patient's blood pressure, it is a common practice to temporarily
affix the blood-pressure device to the patient's upper arm.
[0036] In yet another preferred embodiments of the present
invention, the body-fastener is a simple strip of adhesive that
lines cuff 30 and is covered with a plastic covering. The user can
then remove the plastic covering and temporarily affix the cuff 30
to the contact-portion of the patient's body, much like healthcare
professionals affix a Band-Aid to the skin of patients. In certain
preferred embodiments of the present invention, Velcro.RTM. straps,
adhesive strips, adhesive straps, zip-lock opening-closing devices,
glue strips, combinations of the aforementioned adhesive
mechanisms, or other mechanisms are used as fasteners to
non-permanently attach the cuff 30 to the contact-portion of the
patient's body.
[0037] In the most preferred embodiments of the present invention,
outer bag 8 can be quickly and selectively detached from inner bag
10. In certain embodiments of the present invention, Velcro.RTM.
straps, adhesive strips, adhesive straps, zip-lock opening-closing
devices, glue strips, or other mechanisms are used as fasteners to
temporarily attach outer bag 8 to inner bag 10, which would allow
the health care professional using the device to quickly and easily
detach outer bag 8 from inner bag 10 so that outer bag 8 could be
discarded and inner bag 10 could remain temporarily attached to the
patient (for purposes of explanation, these various fasteners may
be termed "bag-fasteners"). One or more clasp-fasteners, such as a
holding tab 72, could be constructed from virtually any material
and could be fastened to the exterior 9 of outer bag 8. In the most
preferred embodiments, a holding tab or holding tabs can be
manually clasped by the healthcare professional's hand (or by a
healthcare professional who is using an instrument such as
tweezers). When the healthcare worker desires to remove outer bag
8, the healthcare worker can then grasp holding tab 72 to pull off
outer bag 8 from inner bag 10 or grasp holding tab 72 while
removing inner bag 10 from outer bag 8 so that inner bag 10 is no
longer disposed, that is nested, within outer bag 8.
[0038] Referring now to FIG. 1 and FIG. 2, a hem portion 28 of
inner bag 10 is the portion of inner bag 10 that extends beyond
cuff portion 24, 24' of outer bag 8. In the most preferred
embodiments, cuff portion 30 comprises a hem 28 and outer bag 8,
inner bag 10, cuff 30, and one or more fasteners are combined into
a single barrier-dressing device 3. During assembly of the
barrier-dressing device 3, hem 28 is folded back over, that is,
doubled back over, defining both a fold-line 86 and cuff-portion
24, 24'' of outer bag 8. Cuff 30 is approximately twice as long as
the hem 28.
[0039] Cuff 30 most preferably comprises hem 28 as well as a
portion of inner bag 10 that is approximately equal in length and
area to hem 28, adjacent to hem 28 and fold-line 86, and that does
not extend beyond outer bag 8. Cuff 30 is U-shaped so that
cuff-portion 24, 24'' of outer bag 8 can then be inserted down the
middle of the cuff 30.
[0040] Once cuff-portion 24, 24'' of outer bag 8 has been inserted
down the middle of cuff 30 then, in the most preferred embodiments,
if the cuff 30 is oriented in the same direction as the letter "U",
then the combination of cuff 30 and cuff-portion 24, 24' of outer
bag 8 resembles the letter "E" that has been rotated 90.degree. in
the counterclockwise direction (the main difference is that
cuff-portion 24, 24' of outer bag 8 is usually not selectively
attached to cuff 30, and if cuff-portion 24, 24' of outer bag 8 is
selectively attached to cuff 30, then the cuff-portion 24, 24' is
detachably attached to outer bag 8 so that outer bag 8 can be
removed.)
[0041] Referring now to FIG. 2, a bag-fastener 40, 40' of cuff 30
is selectively configured to non-permanently attach outer bag 8 to
inner bag 10. In the most preferred embodiments, bag-fastener 40,
40' non-permanently attaches an attaching-portion 88, 88 of
exterior 9 of outer bag 8 to the distal interior 80, 80' of the
cuff, which is coextensive with a portion of exterior 12 of inner
bag 10, and/or non-permanently attaches a second attaching-portion
90, 90 of the interior space 60 of outer bag 8 to the proximate
interior 82, 82 of cuff 30. Some non-limiting examples of fasteners
that can be used in the most preferred embodiments include hook and
loop (e.g., Velcro.RTM.) fasteners, zip-lock devices, strips of
non-permanent glue, zippers, tie-strings, hooks and loops, and
buttons and buttons holes.
[0042] In the most preferred embodiments of the present invention,
there is at least one bag-fastener 40, 40' that temporarily
attaches a portion of inner bag 10 to a portion of outer bag 8. In
some embodiments, there may be a plurality of fasteners 40, 40'
located on cuff 30 or on cuff-portion 24, 24' of outer bag 8. In
certain other embodiments of the present invention, as long as the
bag-fastener 40, 40' non-permanently attaches outer bag 8 to inner
bag 10, then bag-fastener 40, 40' could be located on outer bag 8,
on inner bag 10, or on both outer bag 8 and inner bag 10 in a
distal location relative to cuff 30. In other embodiments, no
bag-fastener 40, 40' is necessary and cuff-portion 24, 24' of outer
bag 8 is inserted into cuff 30 and kept in place by gravity or by
the folding of hem 28. In the most preferred embodiments,
contact-portion 58 of patient's body 13 is not coextensive, that
is, does not overlap, with target area 14 of patient's body 13 that
is to be disinfected or sterilized and maintained in an aseptic
condition.
[0043] Referring now to FIG. 1, the most preferred embodiments of
the present invention contemplate the use of at least one aerating
mechanism 2, that is, any mechanism that can be selectively
configured to allow one or more disinfectants or antiseptics to
pass through the aerating mechanism 2 and that causes the one or
more disinfectants or the one or more antiseptics to mix with air
and form foam 4 or a foamy-like substance. The foam 4 or foamy-like
substance still retains its disinfecting or antiseptic properties.
In at least one preferred embodiment of the present invention,
sterile substance 70 comprises a liquid or vapor that is directly
applied to the interior space 38 of inner bag 10; however, one
advantage of using aerating mechanism 2 is that foam 4 will
generally weigh less than liquid, which configures device 88 filled
with foam 4 in such a way that a healthcare worker can more easily
handle device 88 filled with foam 4 then if device 88 was filled
with liquid.
[0044] Some non-limiting examples of aerating mechanism 2 are air
stones such as those that are typically used in fish aquariums and
are comprised of materials such as lime wood, porous stones, bonded
glass beads, and/or fiberglass. Air stones of various shapes,
sizes, and levels of coarseness could be used, depending on the
application and variables such as the air-liquid ratio, viscosity
of the disinfectant, size of tubing used to deliver the combined
air/disinfectant stream, etc. In the most preferred embodiments,
aerating mechanism 2 is detachably coupled to the tip of a coupling
mechanism because aerating mechanism 2 and coupling mechanism 92
can be jointly inserted into interior space 38 of inner bag 10.
[0045] In the most preferred embodiments of the present invention,
coupling mechanism 92 comprises one or more lengths of hose or
tubing 50 which are selectively configured to couple an air
delivery mechanism (e.g., air pump) 52 with interior space 38 of
inner bag 10 or interior 60 of outer bag 8. The tubing may be
selectively configured to transport one or more substances; these
substances generally comprise sterile substances 70 and, in certain
embodiments, non-sterile substances. The tubing of the apparatus is
configured to allow substances to move through the tubing, much
like a rubber hose is configured to allow fluid to travel through
the hose. In the most preferred embodiments of the present
invention, tubing 50 is transparent and flexible and the tubing is
configured so that it can allow substances, under controlled
pressure, to travel through the tubing.
[0046] The following list of substances and pressures comprises
substances and types of pressures that the pump can pump, that is
cause to move through, tubing, is non-limiting and non-exhaustive:
disinfectants, antiseptics, air, gases, vapors, mists, liquids,
fluids, moistures, foams, gels, nanoparticles, particles,
molecules, pressure, negative pressure, positive pressure, ambient
pressure, equilibrium pressure, dynamic pressure, vapor pressure,
stagnation pressure, surface pressure, and combinations of the
aforementioned objects and types of pressure. In at least one
preferred embodiment of the present invention, one or more lengths
of tubing 50 are connected to one or more optional valves 15.
[0047] In certain preferred embodiments of the present invention, a
single length of tubing 50 may be used to connect the pump with
inner bag and outer bag; however, in other embodiments, a length of
tubing could be connected to a valve and the valve could be
connected to another length of tubing. Alternatively, the length of
tubing may branch off, and form a "T-connection"; one part of the
tubing could be connected to the plastic bag or container, which
has an interior space, filled with disinfectant of an IV system and
the other part of the tubing could travel through a flow port and
into an inner bag.
[0048] In at least one preferred embodiment of the present
invention, valves 15 are embedded within the one or more lengths of
tubing 50. In other preferred embodiments of the present invention,
a valve 15 is configured to regulate the flow of sterile substance
70 through the tubing 50; a non-limiting example is a one-way valve
15 that prevents the backflow of the sterile substance 70 up the
tubing 50 and towards the pump 52. In some non-limiting
embodiments, valves 15 are adjustable so that the user can control
the rate of flow for sterile substance 70 into interior space 38 of
inner bag 10 (and/or into interior 60 of outer bag 8).
[0049] In the most preferred embodiments of the present invention,
tubing 50 may also be configured to deliver disinfectants,
antiseptics, air, gases, vapors, mists, liquids, fluids, moistures,
foams, gels, nanoparticles, particles, molecules, pressure,
negative pressure, positive pressure, ambient pressure, equilibrium
pressure, dynamic pressure, vapor pressure, stagnation pressure,
surface pressure, and combinations of the aforementioned objects
and types of pressure. In the most preferred embodiments the pump
introduces substances and types of pressure into inner bag via the
tubing, in other words, the pump causes substances and types of
pressure to travel through tubing and travel into the interior
space of inner bag.
[0050] Alternatively, pump can create a vacuum and suck substances
and types of pressure from inner bag. In this application, the pump
can create a negative pressure gradient that will induce fluids,
substances, and other pressures, to exit inner bag, travel through
the tubing, and then enter some type of waste container, bag, or
bowl. In some preferred embodiments of the present invention, a
first pump is used to pump fluid through the tubing and into inner
bag and a second pump is used to create a negative pressure
gradient that will induce excess foam to leave inner bag and travel
through tubing 50. In the most preferred embodiments the pump is a
versatile pump and is configured to alternately pump materials into
inner bag 10 and also to extract materials from within inner bag
10.
[0051] One or more pumps 52 are generally used in the preferred
embodiments; the one or more pumps 52 can be selectively configured
to pump air, gas, vapor, mist, liquid, fluid, moisture, foam 4,
gels, particles, negative pressure, positive pressure, ambient
pressure, equilibrium pressure, dynamic pressure, vapor pressure,
stagnation pressure, and surface pressure, other types of matter,
and combinations thereof into interior space 38 of inner bag 10
and/or interior 60 of outer bag 8.
[0052] In the most preferred embodiments apparatus 88 has one or
more flow ports 42. The one or more flow ports 42 are selectively
configured to allow the length(s) of tubing 50 to pass through the
one or more flow ports 42 and into interior space 38 of inner bag
10 and/or the interior space 60 of outer bag 8. In the most
preferred embodiments, the one or more flow ports 42 are configured
to allow one or more length(s) of tubing 50 and aerating mechanism
2, which is connected to the tip of tubing 50, to pass through an
annular space that is located between cuff 30 and patient's body
13. In some preferred embodiments of the present invention, the one
or more flow ports 42 are selectively configured to allow one or
more lengths of tubing to pass through outer bag and/or inner bag
and into the interior of inner bag at a point that is distal from
the cuff. In the preferred embodiment of the invention, apparatus
27 comprises an IV system, in which the disinfectant and/or aseptic
is contained in a container such as a bottle or bag and then the
force of gravity causes the disinfectant and/or aseptic to drip
down the tubing and into the first end of a T-shaped area of the
tubing where a second end of the T-shaped area of the tubing is
connected with the pump and the third end of the T-shaped area is
connected with tubing, and the tubing travels through the flow port
and into the interior of inner bag.
[0053] In this embodiment, the disinfectant and/or aseptic is then
pumped into the interior of inner bag. In another embodiment one or
more zip-lock open-closing devices are located on inner bag and/or
outer bag. The zip-lock open-closing device(s) can be used to close
the cuff so that it stays snug against the patient's body 13 but
not permanently attached to the contact-portion 58 of the patient's
body 13. In the most preferred embodiments the pump is first used
to introduce a substance such as a disinfectant into the interior
space of inner bag. In some embodiments, the pump sends a packet of
air (or fluid) through the tubing and the force of the moving air
(or fluid) can be used to carry (or move) other objects through the
tubing and into the interior space of inner bag.
[0054] Generally, the tubing is inserted into the interior of inner
bag and has an aerating mechanism, such as an air stone, that is
attached to the tip of the tubing. In the most preferred
embodiments, the pump causes a fluid that is a disinfectant to
travel through the tubing. The fluid exits the tip of the tubing
and then enters the aerating mechanism, such as an air stone. In
the most preferred embodiments, as the fluid travels through the
tubing, the fluid is being mixed with air, and as the mixture of
fluid and air moves through the pores of the air stone, a foam or
an aerated bubble-like substance is formed. In certain preferred
embodiments of the present invention, the mixing of fluid and air
primarily occurs within the pores of the air stone or other
aerating mechanism. In the most preferred embodiments, the amount
of foam can be increased so that inner bag 10 and outer bag 8
inflate and resemble to an inflated balloon. In certain embodiments
of the present invention, substances may be pumped into the
interior space of outer bag, and foam may also be used to fill the
interior space of the outer bag.
[0055] In the most preferred embodiments of the invention, the pump
can then be used to apply negative pressure and extract any excess
foam from inner bag 10. Generally, after the excess foam has been
removed, the pump can then be used to apply negative pressure,
thereby creating a mild vacuum within inner bag 10 and thereby
inducing the interior of inner bag 10 to adhere to the target area.
Generally, in the most preferred embodiments of the present
invention, after the patient has been transported into the surgery
room the pump may be used to apply positive pressure to the
interior space of inner bag 10 so outer bag 8 and inner bag 10 can
be removed just prior to surgery.
[0056] In at least one preferred embodiment of the present
invention, the target area of the patient's body is a relatively
flat surface, such as a chest or a thigh. In these applications, a
multiple layer sterile dressing may be substituted for the nested
bags described above. For these situations, the target area is not
inserted into a bag but is instead covered with the multiple layer
sterile dressing with the aeration mechanism being places in close
proximity to the target area, under the multiple layer sterile
dressing. The edges of the multiple layer sterile dressing may be
temporarily affixed to the target area of the patients body by
adhesive material and the like, with the layers of the multiple
layer sterile dressing serving the same purposes and being used in
substantial conformance to the nested bags previously
described.
[0057] However, in other preferred embodiments of the present
invention, the inner and outer bags are designed so that one or
more target areas of the patient's body can be inserted through the
opening of the bag into the interior space of the inner bag. Some
non-limiting examples of target areas of a patient's body that
could be inserted through an opening of inner bag 10 include: one
or more body parts, limbs, one or more arms, one or more elbows,
one or more fingers, one or more toes, one or more ears, one or
more genitals, one or more buttocks, a nose, a chin, a forehead,
one or more one wrists, one or more palms, one or more hands 5, one
or more legs, one or more knees, a chest, a torso, an abdomen, one
or more shoulders, a back, a head, a face, a neck, and at least one
foot.
[0058] Referring now to FIG. 3, a bottom view of inner bag 10 and a
bottom view of outer bag 8 are shown. Outer bag 8 has either been
removed from inner bag 10 (after outer bag has already been
inserted onto inner bag); alternatively, FIG. 3 depicts a most
preferred embodiment before the cuff has been assembled at the
factory, that is, before inner bag has been inserted into the
interior space 60 of outer bag 8 and/or outer bag has been inserted
onto the exterior of inner bag 10 so that it partially-surrounds
inner bag. The reason that in the most preferred embodiments inner
bag 10 is only partially-surrounded by outer bag, and not
completely surrounded by outer bag 8, is that the opening of inner
bag 10 should be exposed; otherwise, a patient's target area could
not be enclosed by inner bag 8.
[0059] Different sizes and shapes of embodiments of the bags
described herein may be used in conjunction with the various
preferred embodiments of the present invention. The following
dimensions are provided as non-limiting examples of the size of
inner bag orifice as well as the intended application. In one
preferred embodiment of the present invention, inner bag orifice
has a circumference of 10 cm, a length of 12 cm, and is intended
for use with a pediatric foot lower leg or a hand-lower arm. In
another preferred embodiment of the present invention, inner bag
orifice has a circumference of 10 cm, a length of 17 cm, and is
intended for use with a pediatric foot-upper leg or a hand-upper
arm. In yet another preferred embodiment of the present invention,
inner bag orifice has a circumference of 16 cm, a length of 21 cm,
and is intended for use with a small foot-lower leg or a hand-lower
arm.
[0060] In still another preferred embodiment of the present
invention, inner bag orifice has a circumference of 10 cm, a length
of 24 cm, and is intended for use with an extra-small foot-upper
leg or a hand-upper arm. In yet another preferred embodiment of the
present invention, inner bag orifice has a circumference of 16 cm,
a length of 24 cm, and is intended for use with a medium lower leg
or a hand-lower arm. In another embodiment inner bag orifice has a
circumference of 16 cm, a length of 28 cm, and is intended for use
with a medium foot-upper leg or hand-upper arm. In another
embodiment inner bag's 10 orifice 22, 22 has a circumference of 16
cm, a length of 32 cm, and is intended for use with a medium long
foot-upper leg or a hand-upper arm.
[0061] In yet another preferred embodiment of the present
invention, inner bag orifice has a circumference of 20 cm, a length
of 28 cm, and is intended for use with a large foot-lower leg or a
hand-lower arm. In still another preferred embodiment of the
present invention, inner bag orifice has a circumference of 20 cm,
a length of 35 cm, and is intended for use with large foot-upper
leg or hand-upper arm. In another embodiment inner bag orifice has
a circumference of 20 cm, a length of 39 cm, and is intended for
use with a large extra-long foot-upper leg or a hand-upper arm. In
another embodiment inner bag orifice has a circumference of 28 cm,
a length of 44 cm, and is intended for use with an extra-large
foot-upper leg or a hand-upper arm.
[0062] Referring now to FIG. 4, a sterilization apparatus 400 in
accordance with a preferred embodiment of the present invention
comprises: an air source 410; an antiseptic or disinfectant source
420; an optional valve 430; an optional valve 440; a connector 450;
an aeration mechanism 470 and a target area enclosure 470, all
being communicatively coupled via tubing 425.
[0063] Air source 410 may be any type of air pump or air transfer
device capable of pumping air into tubing 425. This may comprise,
for example and not by way of limitation, an aquarium style air
pump or a compressed air delivery system such as those found in
many hospital pre-operative rooms and surgical theaters. In
general, most hospital and clinic preoperative staging areas,
operating rooms and recovery rooms are provided with suction
devices that are suitable for creating a vacuum that is compatible
with the most preferred embodiments of the present invention.
Additionally, compressed air is generally available in most surgery
theaters and oxygen in available in all relevant areas.
[0064] Antiseptic source 420 is any storage and delivery mechanism
for storing and delivering an appropriate antiseptic or
disinfectant material to tubing 425. In at least one preferred
embodiment of the present invention, antiseptic source 420 is a
standard IV drip bag containing a commonly used pre-operative
surgical antiseptic solution used for pre-operative sterilization
of the target area.
[0065] Valves 430 and 440 may be any type of valve known to those
skilled in the art, including without limitation, thumb
controllable "wheel" valves, ball valves, drip valves, etc. The
function of valves 430 and 440 is to control the rate of flow for
the air and the antiseptic solution flowing into aeration mechanism
470 so as to provide the optimal mixture of air and antiseptic
solution for delivery to the target area.
[0066] Connector 450 is most preferably a "T" style union or
connector that joins the tubing 425 that is delivering air from air
source 410 and the tubing 425 that is delivering antiseptic
solution from antiseptic source 420 into a single piece of tubing
425. The combined flow air and antiseptic stream is introduced into
aeration mechanism 470 via another section of tubing 425.
[0067] Target area enclosure 460 is configured to isolate the
target area from neighboring areas and from contact with other
possible sources of contamination. As previously explained, in at
least one preferred embodiment of the present invention, target
area enclosure 460 is a set of sterile bags, with a first bag being
positioned with a second bag. By utilizing a double bag or double
layer of protection, the target area can be sterilized in a
pre-operative environment. After sterilization has been completed,
the patient may be transported to the operating room for the
necessary procedure.
[0068] Aeration mechanism 470 is contained within target area
enclosure 460 and is configured to create a foaming substance from
the mixture of air from air source 410 and the antiseptic solution.
The resultant foamy substance will coat the target area,
effectively sterilizing the target area so as to ensure a sterile
environment for the planned medical procedure. Aeration mechanism
470 may be any type of device known to those skilled in the art
that is capable of producing a foamy substance from the combined
air and antiseptic delivered from air source 410 and antiseptic
source 420. In at least one preferred embodiment of the present
invention, aeration mechanism 470 is a standard aquarium air stone
that is coupled to tubing 425 and contained within target area
enclosure 460.
[0069] Referring now to FIG. 5, a flowchart for a method 500 for
accomplishing sterilization of a target area in accordance with a
preferred embodiment of the present invention is depicted. As shown
in FIG. 5, the target area is covered with a single-layer or
multi-layer protective covering (step 510). As described above,
this may be a series of nested bags or a multiple layer dressing
that is applied over and/or around the target area that is to be
sterilized. Next, the aeration mechanism is positioned within the
protective covering, in close proximity to the target area (step
520) and the sterilization substance is introduced into the area
between the protective covering and the target area (step 530),
thereby inducing the sterilization substance to contact the target
area, effectively disinfecting and sterilizing the target area.
[0070] Once the proper amount of sterilization substance has been
introduced, the aeration mechanism may be removed from within the
protective covering (step 540) and the protective covering may be
closed off to prevent any contaminants from entering into the
protective covering and contacting the target area (step 550). As
shown in FIG. 5, this process may be repeated for multiple target
areas on a single patient, if desired or necessary, depending on
the contemplated procedure or procedures.
[0071] With the protective covering securely in place, and with the
aeration mechanism removed, the patient is ready to be transported
to the room or suite where the procedure will be performed (step
560). When it is time to begin the procedure, the outer layer of
the protective covering may be removed (step 570). Step 570 may be
performed just prior to entering the room or suite where the
procedure is to be performed, if desired. With the outer layer of
protective covering removed, the medical personnel may open or
remove the inner layer of the protective covering (step 580) and
perform the scheduled procedure (step 590).
[0072] Referring now to FIG. 6, a disposable garment top 600 for
use in sterilization procedures in accordance with an alternative
preferred embodiment of the present invention is depicted. In the
most preferred embodiments of the present invention, garment top
600 is fabricated from a durable, yet lightweight disposable
plastic material that can be manufactured in a process that
produces clothing-like garments. In this case, garment top 600 may
be manufactured in multiple standard sizes (e.g., small, medium,
large, etc.) according to the various body types and sizes that may
require sterilization of one or more target areas prior to
undergoing surgical procedures.
[0073] In the most preferred embodiments of the present invention,
garment top 600 will be manufactured with perforated seams that
form "tear-off" or "tear-open" components, allowing for quick and
easy access to the previously identified target areas after
sterilization has been completed. As shown in FIG. 6, garment top
600 has a plurality of perforated reinforced seams 610 that are
strategically placed along the arm openings, at the waist, and
along the front of the garment. It is also anticipated that the
back of garment top 600 may also be configured with a perforated
and reinforced seam along the back as well (not shown this FIG.),
parallel to and opposite the perforated reinforced seam on the
front of garment top 600. Seams 610 are provided so that garment
top 600 can be opened up and or removed without the necessity of
completely removing garment top 600 from the body of the patient
once the sterilization of the target area has been
accomplished.
[0074] In addition, each of the perforated seams 610 of garment top
600 will be most preferably covered with a "release" tape 620 that
serves at least two important purposes. First, release tape 620
provides a protective barrier or seal that minimizes or prevents
any external environmental contaminants from entering into garment
top 600 via perforated seams 610. Second, release tape 620 provides
an additional structural element that prevents the separation of
the various components of garment top 600 prior to the desired
time. Further, an attachment portion 630 may be provided so as to
allow garment top 600 to be securely taped or otherwise fastened to
the patient's body, thereby securing garment top 600 in place.
[0075] In practice, garment top 600 will be placed over a patient
who is scheduled to undergo a surgical or other medical procedure
that requires the sterilization of a target area that will be
covered by garment top 600. As previously explained above, a
sterilization. In at least one alternative preferred embodiment of
the present invention, the sterilization solutions will be
prepackaged inside garment top 600, thereby obviating the need for
the introduction of a sterilization substance into garment top
600.
[0076] Once the patient has donned garment top 600 and the target
areas have been appropriately sterilized by contact with a
sterilization substance, the patient will continue to wear garment
top 600 until it is time for the procedure to take place. This
allows the patient to be prepared for the procedure well in
advance, thereby ensuing a more timely and successful preparation
process.
[0077] In this fashion, a patient may assist in the sterilization
process prior to receiving anesthesia and it will be easier to
accomplish the pre-operative sterilization of the target area(s) in
a pre-operative environment. Additionally, the disinfected target
areas will be protected from inadvertent contamination during the
transport of the patient from the pre-operative environment into
the surgical theater or operating room. Once the patient has
entered the surgical environment, release tapes 620 on garment top
600 may be removed, exposing perforated seams 610. The operating
room personnel may then open and or remove the desired portions of
garment top 600, thereby exposing the desired target areas of the
patient.
[0078] Referring now to FIG. 7, a disposable garment bottom 700 for
use in sterilization procedures in accordance with an alternative
preferred embodiment of the present invention is depicted. In the
most preferred embodiments of the present invention, garment bottom
700 is fabricated from a durable, yet lightweight disposable
plastic material that can be manufactured in a process that
produces clothing-like garments. In this case, garment bottom 700
may be manufactured in multiple standard sizes (e.g., small,
medium, large, etc.), according to the various body types and sizes
that may require sterilization of one or more target areas prior to
undergoing surgical procedures.
[0079] In the most preferred embodiments of the present invention,
garment bottom 700 will be manufactured with perforated seams that
form "tear-off" or "tear-open" components, allowing for quick and
easy access to the previously identified target areas after
sterilization has been completed. As shown in FIG. 7, garment
bottom 700 has a plurality of perforated reinforced seams 710 that
are strategically placed along the arm openings, at the waist, and
along the front of the garment. It is also anticipated that the
back of garment bottom 700 may also be configured with a perforated
and reinforced seam along the back as well (not shown this FIG.),
parallel to and opposite the perforated reinforced seam on the
front of garment bottom 700. Seams 710 are provided so that garment
bottom 700 can be opened up and or removed without the necessity of
completely removing garment bottom 700 from the body of the patient
once the sterilization of the target area has been
accomplished.
[0080] In addition, each of the perforated seams 710 of garment
bottom 700 will be most preferably covered with a "release" tape
720 that serves at least two important purposes. First, release
tape 720 provides a protective barrier or seal that minimizes or
prevents any external environmental contaminants from entering into
garment bottom 700 via perforated seams 710. Second, release tape
720 provides an additional structural element that prevents the
separation of the various components of garment bottom 700 prior to
the desired time. Further, an attachment portion 730 may be
provided so as to allow garment bottom 700 to be securely taped or
otherwise fastened to the patient's body, thereby securing garment
bottom 700 in place.
[0081] In practice, garment bottom 700 will be placed over a
patient who is scheduled to undergo a surgical or other medical
procedure that requires the sterilization of a target area that
will be covered by garment bottom 700. As previously explained
above, a sterilization. In at least one alternative preferred
embodiment of the present invention, the sterilization solutions
will be prepackaged inside garment bottom 700, thereby obviating
the need for the introduction of a sterilization substance into
garment bottom 700.
[0082] Once the patient has donned garment bottom 700 and the
target areas have been appropriately sterilized by contact with a
sterilization substance, the patient will continue to wear garment
bottom 700 until it is time for the procedure to take place. This
allows the patient to be prepared for the procedure well in
advance, thereby ensuing a more timely and successful preparation
process.
[0083] In this fashion, a patient may assist in the sterilization
process prior to receiving anesthesia and it will be easier to
accomplish the pre-operative sterilization of the target area(s) in
a pre-operative environment. Additionally, the disinfected target
areas will be protected from inadvertent contamination during the
transport of the patient from the pre-operative environment into
the surgical theater or operating room. Once the patient has
entered the surgical environment, release tapes 720 on garment
bottom 700 may be removed, exposing perforated seams 710. The
operating room personnel may then open and or remove the desired
portions of garment bottom 700, thereby exposing the desired target
areas of the patient.
[0084] Referring now to FIG. 8, garment top 600 of FIG. 6 is
depicted after it has been opened, along seams 610. After having
been opened along seams 610, the arm portions may be removed, if
desired. In this fashion, the desired target areas can be exposed
for the necessary procedure to take place.
[0085] Referring now to FIG. 9, garment top 700 of FIG. 7 is
depicted after it has been opened, along seams 710. After having
been opened along seams 710, the desired target areas can be
exposed for the necessary procedure to take place.
[0086] Referring now to FIG. 10, a garment top 1000 in accordance
with an alternative preferred embodiment of the present invention
is depicted. In this preferred embodiment of the present invention,
perforated seams 610 of FIG. 6 have been replaced by a "zip-lock"
mechanism 1010 and release tapes 620 have been replaced by a
repositionable and re-fastenable strip 1020 that can be folded over
zip-lock mechanism 1010 as desired.
[0087] Referring now to FIG. 11, garment bottom 700 of FIG. 7 has
been provided with optional "pull tabs" 1130. Pull tabs 1130 are
used to position garment bottom 700 over the patient and will allow
medical personnel to handle and remove all or portions of garment
bottom 700 as may be desired or necessary without contaminating the
disinfected target areas being protected by garment bottom 700.
[0088] Referring now to FIG. 12, attachment mechanism 1210 (e.g.,
adhesive tape) is shown as used to attach garment top 600 and/or
garment top 700 to the patient's body. Attachment mechanism 1210
may be strategically positioned wherever it is needed to ensure
that garment top 600 and/or garment top 700 remain securely in
place until the patient is ready to undergo the necessary
procedure.
[0089] Referring now to FIG. 13, an apparatus 1300 for use in
sterilization activities in accordance with an alternative
preferred embodiment of the present invention is depicted. As shown
in FIG. 13, apparatus 1300 most preferably comprises a body 1305,
an opening 1335 that is configured to provide access into the
interior space of body 1305, a strap 1310 attached to body 1305, at
least one but preferably two tabs 1330 attached to body 1305, an
adhesive zone 1320 on strap 1310, and a pair of perforated seams
1350.
[0090] In addition, a delivery system for providing antiseptic or
disinfectant into the interior space of body 1305 is depicted. As
explained above in conjunction with FIG. 4, the most preferred
embodiments of the delivery system typically comprises a tubing
1340 and an aeration mechanism 1360 affixed or attached to tubing
1340 and attached to one or more pumps as shown in FIG. 4 (not
shown this FIG.).
[0091] As shown in FIG. 13, first perforated seam 1350 is
substantially parallel with a longitudinal axis 1390 of body 1305.
Second perforated seam 1350 is positioned around the circumference
of body 1305 and substantially perpendicular the first perforated
seam 1350. When deploying apparatus 1300, the patient will place
their appendage (e.g., arm, leg, etc.) into opening 1335 of body
1305.
[0092] Once the appendage has been positioned within the interior
space of body 1305, strap 1310 can be wrapped around the appendage
and body 1305 and secured by affixing adhesive zone 1320 to body
1305. Once strap 1310 has been wrapped around the appendage and
secured to body 1305, the antiseptic or disinfectant can be
introduced into the interior space of body 1305 via the delivery
system. As previously explained, this will serve to sterilize the
appendage that has been secured inside body 1305. From this point
forward, the patient can be transported to the location where the
planned procedure can be performed.
[0093] The antiseptic may be introduced into the interior of body
1305 via the delivery system prior to securing the device first and
then strap 1310 will be secured around the appendage and adhered to
body 1305 by deploying adhesive zone 1320. This procedure will
allow excessive air to be evacuated from the interior of body 1305,
thereby enhancing the surface contact of the antiseptic with the
skin of the patient. However, it is also possible that the
antiseptic may be introduced into the interior of body 1305 after
strap 1310 has been positioned and tightened in place.
[0094] Prior to performing the procedure, body 1305 can be removed
from the patient by firmly grasping tabs 1330 and pulling the
bottom portion of body 1305 in a direction that is substantially
parallel to axis 1390, causing a tear along second perforated seam
1350, thereby exposing the appendage.
[0095] Tubing 1340 and an aeration mechanism 1360 comprise a
delivery system for delivering antiseptic or disinfectant to the
desired location within the interior space of body 1305. This
allows for the sterilization of the body member positioned within
the interior space of body 1305.
[0096] By utilizing the apparatus and method described herein, the
sterilization of the target area may be performed in the most
convenient location, without causing any delay in the procedure
once the patient enters into the room or suite where the procedure
is to be performed. Additionally, the target area is protected from
inadvertent contamination during the process of transporting the
patient to the room or suite where the procedure is to be
performed.
[0097] From the foregoing description, it should be appreciated
that apparatus and methods for providing enhanced sterilization of
target areas prior to surgical procedures is provided and presents
significant benefits that would be apparent to one skilled in the
art. Furthermore, while multiple embodiments have been presented in
the foregoing description, it should be appreciated that a vast
number of variations in the embodiments exist. Lastly, it should be
appreciated that these embodiments are preferred exemplary
embodiments only and are not intended to limit the scope,
applicability, or configuration of the invention in any way.
Rather, the foregoing detailed description provides those skilled
in the art with a convenient road map for implementing a preferred
exemplary embodiment of the invention, it being understood that
various changes may be made in the function and arrangement of
elements described in the exemplary preferred embodiment without
departing from the spirit and scope of the invention as set forth
in the appended claims.
* * * * *