U.S. patent application number 14/472004 was filed with the patent office on 2015-05-28 for sterilization wraps and methods for sterilizing articles.
This patent application is currently assigned to ALLEGIANCE CORPORATION. The applicant listed for this patent is ALLEGIANCE CORPORATION. Invention is credited to CLAY CANNADY, MICHAEL DUSKI, BRIAN G. HOGE, Gregory STECKLEIN, JAMES F. WHITAKER.
Application Number | 20150147512 14/472004 |
Document ID | / |
Family ID | 34423178 |
Filed Date | 2015-05-28 |
United States Patent
Application |
20150147512 |
Kind Code |
A1 |
CANNADY; CLAY ; et
al. |
May 28, 2015 |
STERILIZATION WRAPS AND METHODS FOR STERILIZING ARTICLES
Abstract
There is provided an improved sterilization wrap and a method
for using the improved sterilization wrap to sterilize an article.
The wrap is made of at least one sheet, and preferably two sheets,
of sterilization material and in some embodiments, includes an
additional sheet which may be made of an absorbent material. The
sheet of absorbent material may have a smaller perimeter than at
least one sheet of sterilization material. One side of at least one
sheet of sterilization material includes a central portion. The
absorbent material may be attached to the central portion of at
least one sheet of sterilization material. The article to be
sterilized is placed on the sterilization wrap and is then wrapped.
The absorbent material provides sterility protection for the
article in addition to the at least one sheet of sterilization
material and also wicks moisture away from the article after
sterilization has taken place. A visual indicator may be provided
to indicate whether or not the article has been exposed to adequate
sterilization conditions.
Inventors: |
CANNADY; CLAY; (Highland
Park, IL) ; DUSKI; MICHAEL; (BUFFALO GROVE, IL)
; HOGE; BRIAN G.; (FLETCHER, NC) ; STECKLEIN;
Gregory; (LAKE VILLA, IL) ; WHITAKER; JAMES F.;
(ALEXANDER, NC) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ALLEGIANCE CORPORATION |
McGaw Park |
IL |
US |
|
|
Assignee: |
ALLEGIANCE CORPORATION
McGaw Park
IL
|
Family ID: |
34423178 |
Appl. No.: |
14/472004 |
Filed: |
August 28, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13910929 |
Jun 5, 2013 |
8821808 |
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14472004 |
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10685545 |
Oct 14, 2003 |
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13910929 |
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Current U.S.
Class: |
428/57 ; 428/212;
428/516 |
Current CPC
Class: |
B32B 2439/02 20130101;
B32B 2250/03 20130101; A61L 2/07 20130101; B65D 75/08 20130101;
A61B 50/31 20160201; Y10T 428/19 20150115; B32B 27/32 20130101;
Y10T 428/31913 20150401; A61L 2/206 20130101; B32B 2250/242
20130101; A61B 2050/314 20160201; A61L 2/26 20130101; A61L 2202/181
20130101; A61L 2202/24 20130101; A61L 2/28 20130101; Y10T 428/24942
20150115; B32B 27/08 20130101; A61B 50/3001 20160201; B32B 7/05
20190101 |
Class at
Publication: |
428/57 ; 428/516;
428/212 |
International
Class: |
A61L 2/26 20060101
A61L002/26; B32B 27/32 20060101 B32B027/32; B32B 27/08 20060101
B32B027/08; B32B 7/04 20060101 B32B007/04 |
Claims
1-92. (canceled)
93. A sterilization wrap for wrapping an article to be sterilized
comprising: a first sheet having a central portion, wherein the
first sheet is made of spunbonded-meltblown-spunbonded material; a
sheet of reinforcement material wherein at least a portion of the
sheet of reinforcement material is bonded to the central portion of
the first sheet and adapted to receive the article to be
sterilized, wherein the sheet of reinforcement material is made of
spunbonded-meltblown-spunbonded material; and a second sheet made
of spunbonded-meltblown-spunbonded material and bonded to the first
sheet; wherein the sterilization wrap is configured such that when
the article to be sterilized is wrapped by the sterilization wrap,
at least a portion of both the bottom and the sides of the article
to be sterilized is covered by at least a portion of the sheet of
reinforcement material and at least a portion of the top of the
article to be sterilized is covered by at least a portion of the
first sheet.
94. The sterilization wrap as set forth in claim 93, wherein at
least a portion of an outer periphery of the first sheet is bonded
to at least a portion of an outer periphery of the second
sheet.
95. The sterilization wrap as set forth in claim 94, wherein the
entire outer periphery of the first sheet is bonded to the entire
outer periphery of the second sheet.
96. The sterilization wrap as set forth in claim 93, wherein the
perimeter of the sheet of reinforcement material is substantially
contained within the perimeter of the first sheet.
97. The sterilization wrap as set forth in claim 93, wherein the
perimeter of the sheet of reinforcement material is smaller than
the perimeter of the first sheet.
98. The sterilization wrap as set forth in claim 93, wherein the
area of the sheet of reinforcement material is smaller than the
area of the first sheet.
99. The sterilization wrap as set forth in claim 93, wherein the
sheet of reinforcement material comprises a single sheet of
reinforcement material.
100. The sterilization wrap as set forth in claim 93, wherein the
sheet of reinforcement material has a different color than the
first sheet.
101. The sterilization wrap as set forth in claim 93, wherein the
sheet of reinforcement material is made of
spunbonded-meltblown-spunbonded material of equal or higher basis
weight than the spunbonded-meltblown-spunbonded material of the
first sheet.
Description
BACKGROUND OF THE INVENTION
[0001] This invention relates to sterilization wrap. More
particularly, it relates to sterilization wrap utilizing two layers
or sheets of material.
[0002] Reusable medical instruments must be sterilized prior to
each use. Normally, these instruments are exposed to a sterilant to
achieve sterilization. As used herein, the term steriliant is meant
to refer to the sterilization effectors that are conventionally
utilized with sterilization wrap, sterilization techniques,
including but not limited to steam, ethylene-oxide, plasma, or the
like. In order for the instruments to remain sterile after the
sterilization procedure, the instruments must be wrapped in a
material called sterilization wrap prior to the sterilization
procedure.
[0003] The most common type of sterilization wrap is a three-ply
laminate consisting of a layer of melt blown polypropylene
sandwiched between two layers of spun bond polypropylene. The wrap
includes bond points all across the face of the material so that
the material is held together, i.e., laminated. This three-ply
material is commonly referred to as "SMS", which is short for spun
bond-melt blown-spun bond. Most hospitals specify SMS as the
sterilization wrap to be used because SMS is sufficiently porous to
permit steam, ethylene-oxide and other sterilization materials to
penetrate through the material to the surgical instruments, but has
filtration properties sufficient to prevent the passage of most
pathogens therethrough so as to maintain sterility after the
sterilization process. The wrap also protects articles during
sterilization, and acts as a filtration medium for the
sterilant.
[0004] In most hospitals, there is a protocol which requires
surgical instruments to be wrapped with two separate sheets of
material so that if one sheet becomes torn, there is a redundancy
which will maintain the sterility of the surgical instruments. The
wrapping of surgical instruments with two separate sheets of
sterilization wrap obviously is labor intensive in that the
clinician must first place the instruments on one sheet of
sterilization material and wrap the instruments, and then place the
wrapped package on another sheet of sterilization material and
again wrap the package containing the instruments.
[0005] in an attempt to reduce the labor required to provide dual
wrapping of surgical instruments, Kimberly-Clark Corporation has
developed a product called "One Step.RTM. Sterilization Wrap." One
Step.RTM. Sterilization Wrap is made by bonding two separate sheets
of sterilization wrap together near two of the edges of the
adjacent sheets. The Kimberly-Clark One Step.RTM. product is
described in U.S. Pat. Nos. 5,635,134 and 5,688,476.
[0006] FIG. 1 herein shows one of the Kimberly-Clark One Step.RTM.
products described in these Kimberly-Clark patents. Sterilization
wrap 10 includes a top sheet 12 made of SMS and a bottom sheet 14
also made of SMS. The lengths and widths of top sheet 12 and bottom
sheet 14 are identical and the outside edges of each layer align
with one another. The two layers of SMS are bonded together near
two opposing edges 16 and 18, as illustrated by bond lines 20 and
22. The method of bonding the two sheets together may be ultrasonic
bonding. The other two opposing edges 24 and 26 are not bonded
together so there is a visible gap 28 between sheets 12 and 14 so
that the user of the sterilization wrap visually distinguishes the
fact that there are, indeed, two sheets. Apparently the purpose for
ensuring that the two sheets are visually distinguishable as
separate sheets is so that the user knows with certainty that the
item to be sterilized has two sheet protection. However, because of
this gap 28, debris could enter the region between the two sheets.
With two of the edges being unbonded, it is possible that the
sheets become misaligned so that if a sharp object penetrates both
sheets, the resulting holes in each sheet could also become
misaligned, thus reducing ones ability to determine whether or not
there is a hole through both sheets. In addition, since edges 24
and 26 are not bonded and bond lines 20 and 22 are somewhat removed
from edges 16 and 18, fibers from those edges could become released
from the wrap. Also, since the edges 24 and 26 are not bonded, the
two sheets might be pulled apart by mistake during use.
Furthermore, since the wrap shown in FIG. 1 is not sealed right to
the edges 16 and 18, the user might perceive that there could be
contamination between the sheets.
[0007] Recently Cardinal Health has introduced a new two sheet
sterilization wrap called Simul-Wrap.RTM. which overcomes the
problems of the Kimberly-Clark One Step.RTM. product described
above. The Simul-Wrap.RTM. product is made of two identical sheets
of SMS sterilization material which are bonded together along all
four edges. The Cardinal Health Simul-Wrap.RTM. product is shown in
U.S. Pat. No. 6,517,916. However, both the One Step.RTM. product
and the Simul-Wrap.RTM. product have certain drawbacks. Neither
product is specifically engineered to wick moisture away from the
article to be sterilized after sterilization takes place. In
addition, neither product provides an indication that adequate
sterilization has been achieved.
OBJECTS OF THE INVENTION
[0008] It is, therefore, one object of this invention to provide an
improved sterilization wrap which utilizes two layers of
material.
[0009] It is another object of this invention to provide a
sterilization wrap made with two layers of material which is easy
to use.
[0010] It is still another object of this invention to provide a
method for sterilizing an article utilizing an improved
sterilization wrap.
[0011] It is further another object of this invention to provide a
sterilization wrap which will wick moisture from the sterilized
article.
[0012] It is yet another object of this invention to provide a
sterilization wrap which is less costly to manufacture than
conventional sterilization wrap.
[0013] It is another object of this invention to provide a
sterilization wrap which includes a chemical visual indicator
showing that the wrapped article has been exposed to adequate
sterilization conditions.
[0014] It is another object of this invention to provide a two
layer sterilization wrap which includes a chemical visual indicator
to distinguish the sterile field from the non-sterile field when
the wrap has been opened.
SUMMARY OF THE INVENTION
[0015] In accordance with one form of this invention, there is
provided a sterilization wrap for wrapping an article to be
sterilized. At least one sheet, and preferably two sheets, of
sterilization material and a sheet of absorbent material are
provided. The sheet of absorbent material is bonded to a sheet of
sterilization material. The sheet of absorbent material is adapted
to receive the article to be sterilized. The sheet of absorbent
material (a) provides sterility protection for the article in
addition to the sheet of sterilization material, and (b) wicks
moisture away from the article after sterilization has taken place.
The sheet of absorbent material may be made of cellulose or other
absorbent matter which is capable of being formed into a sheet or
layer. Preferably, the sheet of absorbent material is smaller than
the sheet of sterilization material. Also, preferably, one side of
the sheet of sterilization material has a central portion and the
sheet of absorbent material is bonded to the central portion of the
sheet of sterilization material. The sheet of sterilization
material may be a different color from the sheet of absorbent
material so that the user may readily differentiate between the two
sheets and thus distinguish where to place the article being
packaged. Also, preferably, the sheet of absorbent material is
thicker or heavier than the sheet of sterilization material. In
addition, a chemical visual indicator which changes color in the
presence of a sterilant, such as steam, may be attached to either
sheet near the article to be sterilized to indicate whether or not
the article has been exposed to adequate sterilization
conditions.
[0016] In accordance with another form of this invention, there is
provided a sterilization wrap for wrapping an article to be
sterilized. At least one sheet, and preferably two sheets, of
sterilization material, and a sheet of reinforcement material are
provided. The sheet of reinforcement material is bonded to a sheet
of sterilization material. The sheet of reinforcement material is
adapted to receive the article to be sterilized. The sheet of
reinforcement material is preferably made of SMS and preferably has
a higher basis weight than the sheet or either of the sheets of
sterilization material.
[0017] In accordance with another form of this invention, there is
provided a sterilization wrap for wrapping an article to he
sterilized in which at least one sheet, and preferably two sheets
bonded together at their outer peripheries, of sterilization
material are provided. The first sheet has an outer periphery and a
central portion. Also provided is an additional sheet of
reinforcement material that is bonded to the central portion of the
first sheet of sterilization material. The perimeter of the
reinforcement sheet is smaller than the perimeter of the first
sheet.
[0018] In accordance with another form of this invention, there is
provided a sterilization wrap for wrapping an article to be
sterilized, including at least one sheet of sterilization material
and a sheet of absorbent material attached to the sheet of
sterilization material. The sheet of absorbent material is adapted
to contact the article to be sterilized. The sheet of absorbent
material is also capable of wicking moisture away from the article
after sterilization has taken place.
[0019] In accordance with another form of this invention, there is
provided a sterilization wrap for wrapping an article to be
sterilized, including at least one sheet, and preferably two sheets
bonded together, of sterilization material, and a chemical visual
indictor responsive to the presence of sterilant. The chemical
visual indicator will indicate whether the article has been exposed
to adequate sterilization conditions.
[0020] In accordance with another form of this invention, there are
provided methods for sterilizing an article, including the steps of
providing an article to be sterilized, and wrapping the article to
be sterilized with the sterilization wraps described above, and
applying sterilant to the wrapped article.
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] The subject matter which is regarded as the invention is set
forth in the appended claims. The invention itself, however,
together with further objects and advantages thereof may be better
understood in reference to the accompanying drawings in which:
[0022] FIG. 1 is a perspective view of a prior art sterilization
wrap;
[0023] FIG. 2 is a perspective view of the sterilization wrap, in
accordance with one embodiment of the subject invention;
[0024] FIG. 3 is a plan view of the sterilization wrap of FIG. 2
with an article to be sterilized received thereon;
[0025] FIG. 4 is a sectional view of the sterilization wrap of FIG.
2 taken through section line 4-4.
[0026] FIG. 5 is a plan view of another embodiment of the
sterilization wrap in accordance with the subject invention.
[0027] FIG. 6 is a sectional view of the sterilization wrap of FIG.
5 taken through section lines 6-6.
[0028] FIG. 7 is a plan view of yet another embodiment of the
sterilization wrap in accordance with the subject invention.
[0029] FIG. 8 is a sectional view of the sterilization wrap of FIG.
7 taken through section lines 8-8.
[0030] FIG. 9 is a plan view of yet another embodiment of the
sterilization wrap in accordance with the subject invention.
[0031] FIG. 10 is a sectional view of the sterilization wrap of
FIG. 9 taken through section lines 10-10.
[0032] FIG. 11 is a plan view of yet another embodiment of the
sterilization wrap in accordance with the subject invention.
[0033] FIG. 12 is a sectional view of the sterilization wrap of
FIG. 11 taken through section lines 12-12.
[0034] The thicknesses of the materials shown in the drawings have
been exaggerated for illustrative purposes and for ease of
understanding.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0035] Referring now more particularly to FIG. 2, there is provided
sterilization wrap 30 having a first sheet or layer 32 and a second
layer or sheet 34. Preferably, the first layer 32, which is the
outside layer, is made of SMS. The first layer 32 is sometimes
referred to herein as a sheet of sterilization material. The second
layer 34, which is the inside layer, may be made of cellulose or
some other absorbent material, which absorbs liquids and aids in
drying and which also permits a sterilant, such as steam or
ethylene-oxide, to pass therethrough, but inhibits pathogens from
passing therethrough. Other absorbent materials could include, but
are not limited to, absorbent synthetics such as hydrophillic
spunmelt polyolefins, polyester, nylon, as well as polyrayons and
bicomponent fibers. The second layer 34 is sometimes referred to
herein as a sheet of absorbent material. In order to reduce the
cost of the sterilization wrap 30 while not reducing its
effectiveness, the second or inside layer 34 has a smaller
perimeter than the first or outside layer 32. It is preferred that
the perimeter of the inside layer 34 be at least 25% less than the
outside layer 32.
[0036] As can be seen from FIG. 3, the inside layer 34 receives the
article to be sterilized 36 thereon. Often the article to be
sterilized is a tray containing surgical instruments. While inside
layer 34 has a smaller perimeter than outside layer 32, it should
be large enough so that when the article to be sterilized 36 is
wrapped by sterilization wrap 30, both the bottom and sides of the
article to be sterilized 36 is covered by inside layer 34.
[0037] Outside layer 32 includes a central portion 38. Inside layer
34 is adhered to the central portion 38 by means of gluing,
ultrasonic bonding or some other form of adherence. Glue spots 40
are illustrated in FIG. 4. Alternatively, inside layer 34 may be
made of SMS which does not have the liquid absorbent properties of
cellulose. The structure of inside layer 34 when it is made of SMS
is discussed below in reference to FIG. 9. In any event, this
inside layer provides abuse resistance and containment properties
over the prior art sterilization wrap described above.
[0038] By reinforcing the area of direct contact under the article
to be sterilized 36, the primary point of potential damage to the
wrap has been addressed. The method by which trays are wrapped
yield several layers of material folds on the top of the article to
be sterilized 36. In the event that wrapped articles get stacked on
top of one another, thicker and/or heavier inside layer 34 protects
the underside of the article 36 while the multiple folds are
responsive to contact on the top side of article 36.
[0039] As noted, also the inner layer 34 may be made of a moisture
absorbent material, such as cellulose, which provides an enhanced
moisture absorption function. After the article to be sterilized 36
has been sterilized, in particularly through a steam sterilization
process, moisture often remains on the article to be sterilized 36.
This moisture enhances the growth of pathogens which may not have
been killed during the sterilization process. By using an absorbent
material, i.e., absorption material, as the material for layer 34,
this moisture tends to be wicked away from the article to be
sterilized 36 and more effectively dried. Thus the chances of
pathogen growth on or around the article to be sterilized is
greatly reduced.
[0040] It is preferred that outer layer 32 be of a different color
from inner layer 34. Since inner layer 34 is always within the
sterile field, this color differential will inform the sterile
clinician that it is okay to touch any portion of the sterile field
formed by the inside surface of outer layer 32 and inside layer
34.
[0041] It is also preferred that a sterilization chemical visual
indicator 42, which may also be an integrator or emulator, be
adhered to inside layer 34 or to the inside surface 41 of outside
layer 32 in the vicinity of inside layer 34. The sterilization
indicator could be of a chemistry which meets or exceeds the
requirements of Class 1-Class 6 chemical indicators as defined by
ISO-11140-1. The sterilization indicator turns color in the
presence of steam or ethylene-oxide or other sterilant and will
remain at that color after sterilization has taken place. This
informs the clinician that the article to be sterilized has,
indeed, been exposed to adequate sterilization conditions at the
time that the clinician opens the wrapped article.
[0042] Sterilization indicators are known and two such indicators
are described in U.S. Pat. No. 4,514,361 issued to Hirsch and U.S.
Pat. No. 2,889,799 issued to Korpman, which are hereby incorporated
herein by reference. Sterilization integrators are known and one
such integrator is described in U.S. Pat. No. 4,448,548, which is
hereby incorporated herein by reference.
[0043] The sterilization wrap described above can be manufactured
using conventional equipment and techniques readily available to
those skilled in the medical fabric field.
[0044] The sterilization wrap described above may be used as set
forth below. The article to be sterilized 36, as shown in FIG. 3,
is placed on the outside surface of inner layer 34. The article to
be sterilized 36 is then wrapped utilizing standard sterilization
wrapping techniques so that a portion of the inside layer 34 covers
the bottom and sides of the article to be sterilized 36, and a
portion of the outside layer 32 also covers the top of the article
to be sterilized 36. The wrapped package is then exposed to a
sterilization process. The wrapped package is subjected to
sterilants, such as steam, ethylene-oxide or plasma, for a
predetermined period of time so that substantially all of the
pathogens which may be present on the article to be sterilized 36
are killed. The package is then stored for usage. When it is time
to use the article to be sterilized 36, the package is unwrapped by
the clinician. The sterile clinician will know it is all right to
touch the sterile field formed by the inner layer 34 because the
inner layer 34 and the outside layer 32 are different colors. The
clinician will then observe the status of sterilization indicator,
integrator, or emulator 42 to determine whether or not the article
36 has been exposed to adequate sterilization conditions. The
article to be sterilized 36 may then be used.
[0045] The above-described improved sterilization wrap provides the
two layers of protection and ease of use associated with
Kimberly-Clark's One Step.RTM. and Cardinal Health's
Simul-Wrap.RTM., while having the added features of increased
protection in the central area adjacent to the article to be
sterilized and further providing an ability to wick moisture away
from the article to be sterilized, particularly in the case of
steam sterilization, and in addition, visually informs the
clinician that the inside of the wrap is the sterile field and
visually informs the clinician that the article has, indeed, been
exposed to adequate sterilization conditions.
[0046] While FIGS. 2 through 4 show absorbent layer 34 attached to
a single sheet of sterilization material, it is preferred that two
(2) layers of sterilization material are utilized.
[0047] Referring now more particularly to FIGS. 5 and 6, two-layer
sterilization wrap 44 is provided and includes outside layer 46 and
inside layer 48, each made of SMS. The two layers 46 and 48 each
have four edges 49, 51, 53 and 55 and are bonded together at the
four edges about their outer peripheries 50, preferably by heat and
pressure. The bonded two-layer sterilization material 44 may be the
Simul-Wrap.RTM. product which is commercially available from
Cardinal Health (1500 Waukegan Road, McGaw Park, Ill. 60085) and
which is described in U.S. Pat. No. 6,517,916, the disclosure of
which is hereby incorporated herein by reference. Absorbent layer
52, which may be made of cellulose or another moisture absorbing
substance, is bonded to the outside of inner layer 48 by gluing or
another bonding technique, as illustrated by bond sites 54.
Alternatively, layer 52 may be made of SMS as discussed in
reference to FIGS. 2 and 9.
[0048] Referring now more particularly to FIGS. 7 and 8, a
sterilization indicator device 56 is attached to absorbent layer
52.
[0049] Referring now more particularly to FIGS. 9 and 10, the
absorbent layer 52 has been replaced with a reinforcement panel 58
made of SMS. Panel 58 has an equal to or higher basis weight than
either layer 46 or 48. The basis weight of panel 58 may range from
1.0 ounces per square yard (osy) to 3.0 osy. The basis weight for
each of layers 46 and 48 may range from 0.75 osy to 2.9 osy. While
reinforcement panel 58 does not provide the moisture wicking
function of absorption layer 52, it provides additional protection
for the article to be sterilized 36 as shown in FIG. 5, which is to
be placed on reinforcement panel 58. The embodiment shown in FIGS.
9 and 10 results in a more cost effective product than the use of
two full sheets of SMS, but is equal functionally, since less
material is used. FIG. 9 also shows a sterilization indicator 56
having been placed on the outside surface of inner panel 48.
[0050] The embodiment of FIGS. 11 and 12 represents a combination
of the embodiments of FIGS. 7 and 9. That is, reinforcement panel
58 is attached to inside SMS layer 48. Absorbent layer 52 is, in
turn, attached to reinforcement layer 58. Chemical visual indicator
56 is attached to absorbent layer 52. Alternatively, indicator 56
may be attached to reinforcement layer 58 or to inside layer 48. In
addition, in the embodiment of FIGS. 11 and 12, outside SMS layer
could be eliminated.
[0051] From the foregoing description of the preferred embodiments
of the invention, it is apparent that many modifications may be
made therein. It should be understood, however, that these
embodiments of the invention are exemplifications of the invention
only and that the invention is not limited thereto. It is to be
understood, therefore, that it is intended in the appended claims
to cover all modifications as fall within the true spirit and scope
of the invention.
* * * * *