U.S. patent application number 12/167343 was filed with the patent office on 2010-01-07 for cleaning tool for attachment surfaces.
Invention is credited to Thomas J. Shaw, Mark Small, Ni Zhu.
Application Number | 20100000040 12/167343 |
Document ID | / |
Family ID | 41463217 |
Filed Date | 2010-01-07 |
United States Patent
Application |
20100000040 |
Kind Code |
A1 |
Shaw; Thomas J. ; et
al. |
January 7, 2010 |
Cleaning Tool for Attachment Surfaces
Abstract
A tool that is useful for cleaning and disinfecting the
attachment surfaces of a fluid connector device used in medical
applications, the tool having a housing with an opening of defined
shape and a chemically treated flexible insert disposed inside the
housing that substantially conforms to the inside wall of the
housing and, when placed over the attachment surfaces of a fluid
connector device, can be manipulated axially and rotationally
relative to the attachment surfaces to contact, clean and disinfect
the surfaces.
Inventors: |
Shaw; Thomas J.; (Frisco,
TX) ; Small; Mark; (Leonard, TX) ; Zhu;
Ni; (Plano, TX) |
Correspondence
Address: |
Locke Lord Bissell & Liddell LLP;Attn: Michael Ritchie, Docketing
2200 Ross Avenue, Suite # 2200
DALLAS
TX
75201-6776
US
|
Family ID: |
41463217 |
Appl. No.: |
12/167343 |
Filed: |
July 3, 2008 |
Current U.S.
Class: |
15/244.1 |
Current CPC
Class: |
A61M 39/165 20130101;
A61M 39/20 20130101; A61B 90/70 20160201; A61M 39/16 20130101 |
Class at
Publication: |
15/244.1 |
International
Class: |
A47L 13/42 20060101
A47L013/42 |
Claims
1. A tool useful for contacting and applying a cleaner to
attachment surfaces of a fluid connector device used in medical
applications, comprising: a housing with a substantially
cylindrical or polygonal inside wall, an open end having a defined
shape during storage and use, and a closed end opposite the open
end; a flexible insert disposed inside the housing and conforming
substantially to the inside wall, the flexible insert containing
the liquid cleaner prior to contacting the attachment surfaces and
being sufficiently compressible against the attachment surfaces to
discharge said cleaner.
2. The tool of claim 1 when used to mechanically clean a fluid
connector device.
3. The tool of claim 1 wherein the cleaner also disinfects.
4. The tool of claim 4 wherein the cleaner is selected from the
group consisting liquids including alcohol and chlorhexidine.
5. The tool of claim 1 wherein the fluid connector device comprises
a luer connector.
6. The tool of claim 1 wherein the fluid connector device comprises
a Clave.RTM. connector.
7. The tool of claim 1 wherein the flexible insert has a porous
cellular structure.
8. The tool of claim 1 wherein the flexible insert is attached to
the housing.
9. The tool of claim 1 wherein the flexible insert further
comprises a recess.
10. The tool of claim 1 wherein the flexible insert further
comprises a transverse slit.
11. The tool of claim 1 wherein the housing comprises two cavities
separated by an annular collar having an inside diameter less than
that of either cavity.
12. The tool of claim 11 wherein the annular collar has at least
one tapered shoulder.
13. The tool of claim 12 wherein the annular collar has two tapered
shoulders.
14. The tool of claim 1 1 wherein one cavity has a closed end that
is part of the housing.
15. The tool of claim 11 wherein one cavity has a closed end that
is a releasable closure.
16. The tool of claim 11 wherein one cavity is configured to
slidably engage a receptacle.
17. The tool of claim 16 wherein a liquid cleaner is disposed
inside the receptacle.
18. The tool of claim 11 wherein the annular collar defines an
opening that is sealed by a releasable or rupturable closure.
19. The tool of claim 11 wherein the annular collar defines an
opening that is sealed by a removable closure.
20. The tool of claim 1 wherein the inside wall has sections with
different diameters.
21. The tool of claim 1 wherein the inside wall is tapered.
22. The tool of claim 19 wherein the annular collar comprises at
least one projection.
23. The tool of claim 22 wherein the annular collar comprises two
projections.
24. The tool of claim 19 wherein the removable closure comprises at
least one projection.
25. The tool of claim 24 wherein the removable closure comprises
two projections.
26. The tool of claim 1, further comprising a releasable closure
and a projection engageable with the flexible insert.
27. The tool of claim 16 wherein the receptacle is slidable
rotationally in relation to the cavity.
28. The tool of claim 16 wherein the receptacle is slidable
longitudinally in relation to the cavity.
29. A tool useful for cleaning and disinfecting attachment surfaces
of a fluid connector device used in medical applications, the tool
further comprising: a housing having a body with a substantially
cylindrical or polygonal inside wall, an open end having a defined
shape, a closed end; and a flexible insert disposed inside the body
and conforming substantially to the inside wall, the flexible
insert carrying or containing a composition selected from the group
consisting of cleaning agents and disinfectants, and being
configured and sufficiently compressible to receive, contact, clean
and disinfect the attachment surfaces.
30. The tool of claim 29 wherein the fluid connector device is part
of a luer connector.
31. The tool of claim 29 wherein the fluid connector device is part
of a CLAVE.RTM. connector.
32. The tool of claim 29 wherein the fluid connector device
communicates with a needleless syringe, an extension set or an
intravascular catheter.
33. The tool of claim 29 wherein the body is substantially
cylindrical and further comprises coaxially aligned and adjacent
first and second portions having different inside diameters, the
inside diameter of the first portion being greater than the inside
diameter of the second portion.
34. The tool of claim 29 wherein the housing comprises a moldable
polymeric material.
35. The tool of claim 34 wherein the moldable polymeric material
can be glued or sonically welded.
36. The tool of claim 29 wherein the flexible insert comprises a
sponge adapted to receive, store and apply to the attachment
surfaces a composition comprising a disinfectant.
37. The tool of claim 36 wherein the sponge comprises
polyurethane.
38. The tool of claim 36 wherein the disinfectant is selected from
the group consisting of isopropyl alcohol and chlorhexidine.
39. The tool of claim 29 wherein the body has a polygonal inside
wall.
40. The tool of claim 39 wherein the polygonal inside wall
comprises a plurality of circumferentially disposed sidewall
sections, with each adjacent pair of sidewall sections being
separated by a rib.
41. The tool of claim 39 wherein the polygonal inside wall is
octagonal.
42. The tool of claim 29 wherein inside wall of the body is
fluted.
43. The tool of claim 29 wherein the inside wall of the body is
substantially cylindrical.
44. The tool of claim 29 wherein the flexible insert comprises
cooperatively sized and aligned inner and outer elements.
45. The tool of claim 29 wherein the housing and flexible insert
are cooperatively configured to resist relative rotational motion
between adjacent surfaces of each.
46. The tool of claim 45 wherein at least part of the flexible
insert is secured to part of the housing body.
47. The tool of claim 44 wherein the inner element is slidable
relative to the outer element.
48. The tool of claim 29 wherein the housing comprises an open
space adjacent to a part of the flexible insert.
49. The tool of claim 29 wherein the flexible insert is retained
inside the housing by a retainer element attachable to the
housing.
50. The tool of claim 29 wherein the flexible insert comprises a
face substantially coextensive with the defined open end and at
least one slit extending axially away from the face.
51. The tool of claim 29 wherein the defined shape is substantially
circular.
52. The tool of claim 29 wherein the housing further comprises a
handle portion graspable by a user.
53. The tool of claim 52 wherein the handle portion comprises a
reservoir from which the composition is selectively releasable into
the flexible insert.
54. A tool useful for cleaning and disinfecting attachment surfaces
of a fluid connector device used in medical applications, the
cleaning tool further comprising: a housing having a body with a
substantially cylindrical or polygonal inside wall, an open end
having a defined shape, a closed end, and a handle; and a flexible
insert disposed inside the body and conforming substantially to the
inside wall, the flexible insert being configured and sufficiently
resilient to receive and subsequently discharge a composition
selected from the group consisting of cleaning agents and
disinfectants, for use in contacting, cleaning and disinfecting the
frontal attachment surfaces.
55. The tool of claim 54, further comprising a reservoir containing
a composition selected from the group consisting of cleaning agents
and disinfectants.
56. The tool of claim 55 wherein the composition comprises is
selected from the group consisting of alcohol and
chlorhexidine.
57. The tool of claim 56 wherein the alcohol comprises isopropyl
alcohol.
58. The tool of claim 54 wherein the reservoir is a frangible
ampule.
59. The tool of claim 54 wherein the handle further comprises a
flexible side wall, an internal cavity in fluid communication with
the flexible insert, a frangible ampule disposed inside the cavity
and containing the composition, and an activation member that is
manually depressible against the flexible side wall to fracture the
frangible ampule and release the composition.
60. The tool of claim 54 wherein the fluid connector device
comprises a luer.
61. The tool of claim 54 wherein the fluid connector device
comprises a Clave connector.
62. A tool for cleaning attachment surfaces of a fluid connector
device used for a medical application, the tool comprising: a
generally cylindrical housing having first and second cavities with
open ends and an opening establishing fluid communication disposed
between them; an absorbent, flexible insert secured to the inside
wall of the lower cavity; and a substantially cylindrical fluid
receptacle having a closed rear end and an open front end with a
removable stopper or rupturable sealing membrane, the receptacle
slidably engaging the open end of the second cavity, the receptacle
containing a cleaning and disinfecting liquid; wherein the housing
and receptacle are cooperatively configured so that an application
of manual force against the closed end of the fluid receptacle will
cause the stopper or membrane to be displaced from the open front
end, thereby allowing the cleaning and disinfecting liquid to flow
into the flexible insert.
63. The tool of claim 62 wherein the fluid connector device
comprises a CLAVE connector.
64. The tool of claim 62 wherein the fluid connector device
comprises a luer connector.
65. The tool of claim 62 wherein the fluid connector device
comprises a threaded section.
66. The tool of claim 62 wherein the flexible insert comprises a
split or recess to receive at least part of the frontal
attachment.
67. The tool of claim 62 wherein the open front end of the
receptacle further comprises a radially projecting lug.
68. The tool of claim 67 wherein the second cavity comprises two
parallel, proximally positioned slots of different lengths to
receive the lug.
69. The tool of claim 62 wherein the second cavity further
comprises at least one prong that is engageable with the stopper or
membrane to displace the stopper or membrane from the opening of
the receptacle.
70. The tool of claim 62, further comprising a seal or cover
disposed across the open end of the first cavity.
71. The tool of claim 62 wherein the cleaning and disinfecting
liquid is selected from the group consisting of isopropyl alcohol
and chlorhexidine.
Description
BACKGROUND OF THE INVENTION
[0001] 1. Field of the Invention
[0002] This invention relates to a tool that is useful for
mechanical cleaning and/or application of fluids to an exposed or
accessible attachment surface of a fluid connector device used in
medical applications.
[0003] 2. Description of Related Art
[0004] A significant problem that exists today in the delivery of
healthcare services is the accidental transmission of pathogens and
diseases from one patient to another, or from a patient or
healthcare worker to another, by improperly or inadequately cleaned
connectors such as those used in fluid infusion or extraction
therapies. Proper and thorough cleaning of fluid connector devices
and ports is essential, for example, in reducing the incidence of
methycillin-resistant Staphylococcus aureus (MRSA) infections.
[0005] Fluid connectors of medical devices are commonly cleaned
using wipes that are saturated with alcohol or another similarly
effective disinfectant. The wipes are manufactured and stored in
sealed pouches until the time of use, then removed manually by the
user, who holds the wipe in his or her fingers and rubs the wipe
against the exposed surfaces of the attachment surfaces to be
cleaned. Any bacteria or pathogen that is present on the fingers of
the user, typically a healthcare worker who has also been treating
other patients, can be transferred to the wipe and then to the
attachment surfaces of the device, or can be transferred directly
to the device by inadvertent contact between the user's hand and an
attachment surface. Also, because fluid connectors of the
attachment devices frequently comprise a plurality of differing
surfaces having various contours and degrees of exposure, a
conventional wipe may not reach all portions of the surfaces when
manipulated by the user. This is particularly true, for example,
where the fluid connector comprises threads.
[0006] An improved cleaning tool for the attachment surfaces of
fluid connectors used in medical applications is therefore needed
that will reduce the likelihood of direct contact between the hands
of the user and the surface being cleaned, that will better conform
to the contours of the attachment surfaces when manipulated by the
user, and that will apply pressure more evenly around the perimeter
of the fluid connector being cleaned.
[0007] Swab pouches have recently been disclosed in United States
Patent Publication Nos. 2007/0225660 A1, 2008/0038167 A1 and
2008/0039803 A1 for use in covering, protecting and disinfecting
the ends of luers, luer valves, cannulas and the like. Although
such pouches offer some advantages over conventional wipes, a
device is still needed that can be manufactured reliably and that
can be manipulated easily and effectively by a clinician to
mechanically scrub and/or disinfect exposed or accessible
attachment surfaces of fluid connectors used in medical
applications.
SUMMARY OF THE INVENTION
[0008] A tool is disclosed that is useful for mechanically cleaning
and/or applying fluids to an exposed or accessible attachment
surface of a fluid connector device used in medical applications.
As used herein, "fluid" is intended to include liquids, gases, and
solutions, suspensions or slurries. Such fluids can include or
contain, for example, vascular and/or non-vascular fluids,
medicines or flowable cellular tissues, that are infused into, or
extracted or collected from, a patient. As used herein, "fluid
connectors" or "fluid connector devices" can include, for example,
luers, hubs, threaded or unthreaded connectors, Clave.RTM.
connectors, and the like. Medical applications involving fluid
infusion or extraction can include, for example, intravascular,
intraosseous, intracranial, hepatic, lymphatic, subcutaneous,
epidural, or urinary therapies. It should be understood and will be
appreciated, however, by those of ordinary skill in the art upon
reading this disclosure that these examples of fluids, fluid
connector devices and medical applications are not exhaustive of
those in connection with which the cleaning tool of the invention
can be used beneficially.
[0009] According to one preferred embodiment of the invention, a
cleaning and disinfecting tool is disclosed that preferably
comprises a housing having an inside wall and an open end with a
defined shape, and a flexible insert such as a sponge or other
similarly effective material conforming substantially to inside
wall of the housing that can be used to scrub and treat a frontal
attachment with a suitable cleaner or disinfectant. The cleaning
and disinfecting tool can be prepackaged in a sterile wrapper and,
when removed from the package, placed over the attachment surfaces
of a fluid connector device such as the attachment end of a
CLAVE.RTM. connector. The cleaning and disinfecting tool can be
manipulated axially and rotationally relative to the end of the
frontal attachment to scrub the contacted surfaces of the connector
and to apply a chemical capable of cleaning, disinfecting or
otherwise decontaminating the contacted surfaces.
[0010] According to another preferred embodiment of the invention,
the housing of the subject cleaning tool is molded, thermoformed or
stamped from a suitable material, most preferably a polymeric
material. A flexible insert such as a chemically treated sponge is
preferably disposed inside the housing and can further comprise a
centrally disposed opening having interior side and end wall
sections configured to receive and contact external portions of the
free end of a frontal attachment as the cleaning tool is
manipulated by a user. Where the flexible insert is a sponge, the
sponge desirably contains an amount of cleaner or disinfectant and,
optionally, one or more other additives, that is adequate for
decontaminating the frontal attachment with which it is used. Both
the housing and the sponge portion of the cleaning tool are
desirably latex-free to avoid possible allergic reactions with
either the user or a patient.
[0011] According to another preferred embodiment of the invention,
a cleaning and disinfecting tool for attachment surfaces of fluid
connector devices used in medical applications is provided that
comprises a housing with a defined open end and a flexible insert
disposed inside the housing, the insert further comprising a
cleaning or disinfecting composition that is released or releasable
upon contact with one or more attachment surfaces of a fluid
connector. The flexible insert can be unitarily formed or can be
assembled from a plurality of elements, which elements can be
either fixed or moveable relative to each other. The flexible
insert can be made with or without a centrally disposed recess
adapted to receive one or more attachment surfaces of a fluid
connector. The flexible insert is preferably heat-staked to the
inside of the housing, but can also be attached by use of any
available adhesive, welding technique or other attachment method
that is suitable for use with the materials and methods utilized
for making the housing, flexible insert and cleaner or
disinfectant.
[0012] According to another preferred embodiment of the invention,
a cleaning tool for attachment surfaces of fluid connector devices
used in medical applications is provided that comprises a housing
containing a flexible insert as described above, and has an
attached polymeric handle with flexible side walls, a closed end
and a hollow interior cavity with an open end that is in fluid
communication with the flexible insert. The frangible ampule or
another similarly effective fluid reservoir is desirably disposed
inside handle and preferably contains an amount of cleaning and
disinfecting fluid that is sufficient to partially saturate
flexible insert and effectively clean and disinfect the exposed
free end of a frontal attachment inserted into surrounding contact
by the insert. A lever arm with a blunt edge is desirably provided
on the outside of the handle to facilitate the selective
application of manual force against the side wall of handle,
causing it to flex sufficiently to cause fracturing of the
relatively rigid sidewalls of the ampule, thereby releasing
cleaning and disinfecting fluid to flow downwardly by gravity into
the flexible insert.
[0013] According to another preferred embodiment of the invention,
a tool for mechanically cleaning and/or applying fluid to
attachment surfaces of fluid connector devices used in medical
applications is provided that comprises a generally cylindrical
housing having two distinct cavities, one forwardly facing and the
other rearwardly facing, with open ends and with an opening
establishing fluid communication between them. A compressible,
flexible insert preferably having a cellular internal structure is
secured inside the forwardly facing cavity. Another substantially
cylindrical receptacle having a closed rearwardly facing end and an
open forwardly facing end sealed with a removable closure slidably
engages the open end of the rearwardly facing housing cavity. The
housing and receptacle are desirably cooperatively configured so
that an application of force to the closed, rearwardly facing end
of the receptacle will cause projecting prongs to dislodge the
closure. When this occurs, a cleaning and/or disinfecting fluid
such as isopropyl alcohol or chlorhexidine that is stored in the
receptacle can flow either by gravity flow or by a piston effect as
described below to saturate the flexible insert immediately prior
to contacting the insert with the attachment surfaces of the fluid
connector device being cleaned.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] The apparatus of the invention is further described and
explained in relation to the following drawings wherein:
[0015] FIG. 1 is a perspective view of one embodiment of a housing
that is part of a preferred tool useful for cleaning and
disinfecting the exposed attachment surfaces of a frontal
attachment device such as, for example, a CLAVE.RTM. connector, to
another medical device such as, for example, a needleless
syringe;
[0016] FIG. 2 is a top plan view of the housing of FIG. 1;
[0017] FIG. 3 is a front elevation view of the housing of FIG.
1;
[0018] FIG. 4 is a side elevation view of the housing of FIG.
1;
[0019] FIG. 5 is a bottom plan view of the housing of FIG. 1;
[0020] FIG. 6 is a cross-sectional elevation view taken along line
6-6 of FIG. 2;
[0021] FIG. 7 is a perspective view of one embodiment of a
preferred chemically treated cleaning sponge that is insertable
into and attachable to the housing of FIG. 1;
[0022] FIG. 8 is a top plan view of the chemically treated cleaning
sponge of FIG. 7;
[0023] FIG. 9 is a cross-sectional elevation view taken along line
9-9 of FIG. 8;
[0024] FIG. 10 is a cross-sectional elevation view of a preferred
embodiment of the cleaning and disinfecting tool of the
invention;
[0025] FIG. 11 is a front elevation view, partially in section and
partially broken away, of the tool of FIG. 10 being used to clean
and disinfect the attachment surfaces of a fluid connector
device;
[0026] FIG. 12 is a perspective view of another embodiment of a
preferred tool useful for cleaning and disinfecting the exposed
attachment surfaces of a fluid connector device such as, for
example, a CLAVE.RTM. connector, to another medical device such as,
for example, a needleless syringe;
[0027] FIG. 13 is an exploded perspective view illustrating the
component parts of the tool of FIG. 12;
[0028] FIG. 14 is a front elevation view of the tool of FIG.
12;
[0029] FIG. 15 is a bottom plan view of the tool of FIG. 12;
[0030] FIG. 16 is a cross-sectional elevation view taken along line
16-16 of FIG. 14, showing the central portion of the sponge in a
first position;
[0031] FIG. 17 is a cross-sectional elevation view substantially as
shown in FIG. 16, but with the central portion of the sponge in a
second position that is elevated in relation to the first
position;
[0032] FIG. 18 is a perspective view of one embodiment of a
preferred chemically treated cleaning sponge that is configured
differently from the sponge depicted, for example, in FIG. 13;
[0033] FIG. 19 is a cross-sectional elevation view of another
embodiment of the preferred tool of the invention that is similar
to the tool of FIG. 16 but includes a housing that is configured to
receive a chemically treated cleaning sponge having a configuration
like that of the sponge shown in FIG. 18;
[0034] FIG. 20 is a top perspective view of an array comprising a
plurality of housings suitable for use in making a preferred
embodiment of the cleaning tool of the invention prior to
separating them from a web connecting them during manufacture;
[0035] FIG. 21 is front elevation view of a single housing that has
been inverted following separation from the array of FIG. 20;
[0036] FIG. 22 is a cross-sectional elevation view taken along line
22-22 of FIG. 21;
[0037] FIG. 23 is bottom plan view of the housing of FIG. 21;
[0038] FIG. 24 is an exploded bottom perspective view of a cleaning
tool made using the housing of FIG. 21 in combination with a
flexible insert;
[0039] FIG. 25 is a cross-sectional elevation view taken along line
25-25 of FIG. 24;
[0040] FIG. 26 is a front elevation view, partially in section, of
the tool of FIG. 24 being used to clean and disinfect the
attachment surfaces of a fluid connector;
[0041] FIG. 27 is an inclined view, partially in section, of
another embodiment of the subject cleaning tool being used to clean
and disinfect the attachment surfaces of a fluid connector, the
tool comprising a handle with a reservoir containing a cleaning and
disinfecting composition that is selectively releasable into the
flexible insert;
[0042] FIG. 28 is a perspective view of another embodiment of the
subject cleaning tool;
[0043] FIG. 29 is an exploded perspective view of the cleaning tool
of FIG. 28;
[0044] FIG. 30 is a front elevation view of the cleaning tool of
FIG. 28;
[0045] FIG. 31 is a top plan view, partially broken away, of the
cleaning tool of FIG. 28;
[0046] FIG. 32 is a cross-sectional front elevation view of the
cleaning tool of FIG. 28 prior to use;
[0047] FIG. 33 is a cross-sectional front elevation view of the
cleaning tool of FIG. 28 after the fluid receptacle is depressed
relative to the housing to dislodge the stopper and release the
cleaning and disinfecting fluid;
[0048] FIG. 34 is a cross-sectional front elevation view taken
along line 34-34 of FIG. 31, in which the fluid receptacle is
exploded upwardly relative to the housing;
[0049] FIG. 35 is a top plan view, partially broken away, of a
preferred embodiment of another cleaning tool, having a single
longitudinally extending slot in the housing;
[0050] FIG. 36 is a cross-sectional front elevation view taken
along line 36-36 of FIG. 35, in which the fluid receptacle is
exploded upwardly relative to the housing;
[0051] FIG. 37 is a cross-sectional front elevation view of the
housing of a preferred embodiment of another cleaning tool of the
invention;
[0052] FIG. 38 is a cross-sectional front elevation view of the
housing of FIG. 37, with a cleaning fluid disposed inside a
receptacle in the housing and a closure sealing the opening of the
receptacle;
[0053] FIG. 39 is a is a cross-sectional front elevation view of a
preferred embodiment of another cleaning tool of the invention,
comprising the housing of FIG. 37 and the cleaning fluid and
closure of FIG. 38, with an absorbent flexible insert disposed
inside the portion of the housing below the closure;
[0054] FIG. 40 is a bottom perspective view of the flexible insert
of FIG. 39;
[0055] FIG. 41 is bottom perspective view of the closure of FIGS.
38 and 39;
[0056] FIG. 42 is an enlarged detail view taken from a position
substantially as shown in FIG. 37;
[0057] FIG. 43 is a bottom perspective view of another closure as
shown in FIGS. 44-46;
[0058] FIG. 44 is a is a cross-sectional front elevation view of a
preferred embodiment of another cleaning tool of the invention;
[0059] FIG. 45 is a cross-sectional front elevation view of the
cleaning tool of FIG. 44 that is taken transversely to the
cross-sectional view in FIG. 44;
[0060] FIG. 46 is a cross-sectional front elevation view of the
cleaning tool of FIG. 44 being used to clean the attachment end of
a fluid connector;
[0061] FIG. 47 is a bottom perspective view of a flexible insert as
shown in FIGS. 44-46; and
[0062] FIG. 48 is a cross-sectional front elevation view of a
preferred embodiment of another cleaning tool of the invention.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0063] Referring to FIGS. 1-6, a preferred embodiment of the
cleaning and disinfecting tool of the invention comprises housing
10 that is preferably unitarily molded, stamped or thermoformed
from a polymeric composition, thin metallic material or laminate.
If molded or thermoformed, housing 10 preferably comprises a
polymeric material that can be glued or sonically welded. Housing
10 preferably further comprises projecting tab or handle 12 that is
easily graspable by a user, and a substantially cylindrical body
having coaxially aligned upper body section 14 and adjacent lower
body section 16. It should be appreciated that "substantially
cylindrical," as used in this disclosure, can include sections
having different inside or outside diameters and such slopes or
tapers as may be needed or appropriate in view of the particular
configuration and the method and material of construction that are
used in making housing 10. Taken together, upper and lower sections
14, 16 define an open interior space 20 having a stepped inside
diameter, with upper section 14 preferably having an inside
diameter that is less than the inside diameter of lower section 16.
Lower section 16 preferably comprises an open end opposite upper
section 14 that is surrounded and stabilized by flange 18 having
annular face 22. Upper body section 14 further comprises closed end
wall 28 connected to handle 12. The transition between upper and
lower body sections 14, 16 is preferably defined by inclined
annular shoulder 26 at the interior edge of annular stop surface
24.
[0064] Referring to FIG. 10, a preferred embodiment of tool 44 of
the invention is made by inserting and preferably securing a
flexible insert such as a compressible sponge 30 inside open
interior space 20 of the cylindrical body of housing 10, as
discussed above in relation to FIGS. 1-6. Sponge 30 can be secured
inside opening 20 of housing 10 by any suitable means such as, for
example, by use of an adhesive. Desirably, sponge 30 will be
constrained inside housing 10 sufficiently that sponge 30 (and
especially its outside wall) will not be easily rotatable or
translatable relative to the inside walls of housing 10 once sponge
30 is installed. This will facilitate the use of rotational and
axial movement of tool 44, applied through handle 12, to clean and
scrub the exterior attachment surfaces of a frontal attachment
device as described in greater detail below in relation to FIG. 11.
Alternatively, it will be appreciated by those of ordinary skill in
the art upon reading this disclosure that the structure of housing
10 can be modified by the addition of other structural elements to
constrain the movement of sponge 30 relative to the inside walls of
housing 10 frictionally and without the use of an adhesive if
desired.
[0065] Referring again to FIGS. 10-11, sponge 30 preferably has a
configuration that is receivable within the cylindrical body of
housing 12, and that also comprises an opening having a defined
shape into which the attachment surfaces at the free end of a
frontal attachment device such as a CLAVE.RTM. connector are
receivable for cleaning and disinfecting. Sponge 30 is desirably
made of a compressible, open-cell material adapted to receive,
retain and release a composition containing a disinfectant when
sponge 30 is placed in contact with or compressed against an
attachment surface of a frontal attachment device such as a
CLAVE.RTM. connector. Most preferably, sponge 30 will comprise
open-cell polyurethane foam or another similarly effective
non-latex, open-cell material. The dimensions and configuration of
sponge 30 are desirably such that sponge 30 can be positioned and
secured snugly inside housing 10, and, with some compression, will
receive and contact substantially all the surface area of the
attachment surfaces of a frontal attachment device to promote
cleaning and disinfecting of the attachment surfaces.
[0066] Although the flexible insert disposed inside the housing of
the invention is principally referred to as a "sponge" throughout
this disclosure, it should be appreciated by those of ordinary
skill in the art upon reading this disclosure that other similarly
effective molded, woven, porous or layered materials can likewise
be used within the scope of the invention provided that such
materials are capable of retaining prior to use and subsequently
releasing during use an amount of cleaning chemical or disinfectant
that is effective for decontaminating any contacted surfaces of a
frontal attachment to a medical device with which the subject tool
is used. In some cases it can be desirable for a cleaning agent or
disinfectant to be adsorbed into or encapsulated in recesses or
voids disposed inside the flexible insert of the invention.
[0067] Referring again to FIGS. 6-10, sponge 30 preferably
comprises upper cylindrical section 32, lower cylindrical section
34, top surface 36 that abuts and can be adhered to end wall 28 of
housing 10, annular surface 38 that abuts and can be adhered to
annular stop surface 24 of housing 10 and interior space 42 having
an opening defined by bottom surface 40 of lower cylindrical
section 34. Although upper and lower cylindrical sections 32, 34,
respectively, of sponge 30 are depicted in FIGS. 9 and 10 as being
two distinct elements, it should be appreciated that they can be
unitarily formed, or formed separately and joined by any suitable
means known to those of ordinary skill in the art, such as, for
example, by thermal or other welding techniques, by the use of
commercially available adhesives, or the like. Alternatively, as
discussed below in relation to FIGS. 12-17, the
[0068] Referring to FIGS. 9-11, when tool 44 is removed from its
own sterile wrapper, sponge 30 is preferably already impregnated,
substantially saturated or coated with a sufficient amount of a
disinfectant-containing composition, most preferably isopropyl
alcohol or another similarly effective liquid or powder, to achieve
a desired level of decontamination. Tool 44 is then preferably used
by placing it over the attachment surfaces 48 of a frontal
attachment device, such as a CLAVE.RTM. connector that is already
connected by tubing 52 to an extension set or IV catheter (not
shown). Once attachment surfaces 48 are disposed inside the
interior space 42 of tool 40, the inwardly facing side and end
walls of sponge 30 are desirably compressed sufficiently to contact
all the external area of attachment surfaces 48, and upon
compression, will release the disinfectant-containing composition
disposed inside sponge 30 directly onto attachment surfaces 48. By
grasping handle 12, tool 44 can then be manipulated by the user to
scrub attachment surfaces 48 by reciprocating tool 48 in an axial
direction as demonstrated by arrows 54 and rotationally as
indicated by arrows 56. Such scrubbing is believed to provide
better and more effective cleaning and disinfecting than is
achievable using prior art alcohol wipes or napkins.
[0069] Although one embodiment of the apparatus of the invention
that is particularly intended for use with the attachment surfaces
of CLAVE.degree. connectors is disclosed above, it will be
appreciated that other alterations and modifications of the
invention will likewise become apparent to those of ordinary skill
in the art upon reading this specification in view of the
accompanying drawings, and it is intended that the scope of the
invention disclosed herein be limited only by the broadest
interpretation of the appended claims to which the inventors are
legally entitled.
[0070] For example, referring to FIGS. 12-17, another preferred
embodiment of the invention is disclosed wherein cleaning and
disinfecting tool 60 further comprises housing 62 and a flexible
insert 64 that is retained inside housing 60 by retainer ring 74.
Retainer ring 74 can be snapped or pressed into an annular recess
82 on the inside of flange member 72. In this embodiment, housing
62 comprises upper portion 66, lower portion 68 having a plurality
of circumferentially spaced, radially extending ribs 70, and flange
72. The external portions of radially extending ribs 70 provide a
gripping surface for the user, and the internal portions of ribs 70
assist in resists rotational movement of flexible insert 64 inside
housing 62. Although lower portion 68 of housing 62 as shown is
substantially cylindrical, it should be appreciated that housings
having other polygonal cross-sections can likewise be used in the
cleaning and disinfecting tools of the invention.
[0071] Referring to FIGS. 13, 16 and 17, flexible insert 64
comprises an outer section 76 having a centrally disposed
cylindrical bore that is plugged by cylindrical element 78. Outer
section 76 has an octagonal perimeter defined by a plurality of
flat surfaces 84, each of which is preferably sized and configured
to conform substantially to and cooperate with internal ribs 70 of
housing 62 to resist rotational movement of outer section 76
relative to lower portion 68 of housing 62 as cleaning and
disinfecting tool 60 is manipulated by a user while cleaning a
frontal attachment. As with cleaning and disinfecting tool 44
described above in relation to FIG. 11, tool 60 is also desirably
manipulated both axially and rotationally relative to a frontal
attachment during use. Although a lower portion 76 having a
hexagonal perimeter is a preferred structure for use in the
invention, other polygonal configurations can also be used within
the scope of the invention provided that any flexible insert so
configured will conform substantially to and cooperate with the
inside structure and configuration of the associated housing so
that the resultant cleaning and disinfecting tool can function
substantially as disclosed herein. Flexibility is desired to permit
the surfaces that engage a frontal attachment during use to flex
around and contact various portions of the frontal attachment.
[0072] Flexible insert 64 desirably comprises any suitable material
substantially as disclosed above for use in making sponge 30 of the
invention, and is desirably sufficiently compressible to be
inserted into defined interior space 80 of housing 62. If desired,
adhesive can also be used to help hold flexible insert 64 in place.
Retainer ring 74 is desirably seated in annulus 82 of housing 62,
and is preferably pressed or snapped into position to assist in
maintaining outer section 76 of flexible insert 64 in a preferred
axial position inside housing 62 during use. Retainer ring 74 can
be made of rubber, plastic or metal, and can be continuous, contain
a gap, or comprise projections or bosses that cooperate with
housing 62 to retain ring inside annular recess 82.
[0073] As shown in FIGS. 16 and 17, cylindrical element 78 is
preferably made of the same flexible, compressible material as
outer section 76 of flexible insert 64. As shown in FIG. 16,
cylindrical element 78 is axially positioned so that its top and
bottom ends are substantially flush with the corresponding ends of
outer section 76, and interior 86 of upper portion 66 is open.
Then, when cleaning tool 60 is pressed against the tip of a frontal
attachment, cylindrical element 78 can slide upwardly relative to
outer section 76 until cylindrical element 78 engages the closed
end wall of upper portion 66. This provides a substantially
cylindrical space 88 inside housing 62 where portions of flexible
insert 64 face the frontal attachment on three sides in
substantially the same way as is depicted in FIG. 11.
[0074] Still another preferred embodiment of the invention is
depicted and described in relation to FIGS. 18-19. Flexible insert
90 can be made of materials as described above in relation to other
preferred flexible inserts or sponges of the invention, and like
flexible insert 64, comprises an outer section 94 having a
polygonal perimeter that is preferably sized and configured to
cooperate with internal portions of housing 104 to resist
rotational movement of outer section 94 relative to lower portion
108 of housing 104 as cleaning and disinfecting tool 102 is
manipulated by a user while cleaning a frontal attachment. In this
embodiment, however, cylindrical element 92 is initially disposed
above the top of outer section 94, and a cylindrical open space 100
is disposed below it to receive a portion of a frontal attachment
(not shown) that is inserted inside it during use. Cylindrical
element 92 preferably seats against end wall 106 of housing 104,
and can be unitarily made with outer section 94 or not, as
desired.
[0075] As with cleaning and disinfecting tool 44 described above in
relation to FIG. 11, tool 102 is also desirably manipulated both
axially and rotationally relative to a frontal attachment during
use. Although a lower portion 94 having a hexagonal perimeter
comprising side walls 96 is a preferred structure for use in the
invention, either cylindrical or other polygonal configurations can
also be used within the scope of the invention for either the upper
or lower portions of housing 104 provided that any flexible insert
so configured will cooperate with the inside structure and
configuration of the associated housing so that the resultant
cleaning and disinfecting tool can function substantially as
disclosed herein. Flexibility is desired to permit the surfaces
that engage a frontal attachment during use to flex around and
contact various portions of the frontal attachment. If desired,
either element 92 or outer portion 94, or both can also be attached
to the inwardly facing surface of sidewall 108 of housing 104. As
with housing 62, side wall 108 of housing 104 can also function as
a handle for use in manipulating cleaning and disinfecting tool 102
relative to a frontal attachment.
[0076] FIG. 20 depicts an array 120 of polymeric housings 122
suitable for use in making an embodiment of the cleaning tool of
the invention. As shown, housings 122 are interconnected by a
substantially continuous web from which they can be separated by
any suitable conventional method or device such as, for example, by
die cutting around the phantom lines that are intended to represent
the flange perimeters of each respective housing as described
below. Depending upon the material of construction, the depth of
each housing 122, and the side wall configuration of each, array
120 can be injection molded, thermoformed, or otherwise fabricated
using known manufacturing methods. Referring to FIGS. 21-23, each
housing 122 preferably further comprises annular flange 124 around
an opening of defined shape, a continuous, substantially
cylindrical side wall 126, bottom 128, and an inside wall
comprising a plurality of flutes 130.
[0077] Referring to FIGS. 24-26, housing 122 as described above is
desirably configured to receive a flexible insert 132, most
preferably made from a resilient, spongy or elastomeric material
having a side wall 134 that is compressible to facilitate insertion
into interior space 125 of housing 122, whereupon side wall 134
desirably expands slightly to conform substantially to the inside
wall of housing 122 and into engagement with flutes 130, or to be
heat-staked to some portion of the wall, or to a shelf or other
surface adjacent to the wall. Alternatively, other functionally
equivalent methods of attachment, such as sonic welding, gluing or
the like, can also be used. Where flexible insert 132 is attached
to the wall, the presence of flutes or other irregularities on the
surface of the inside wall are not needed to resist rotational
movement of the insert inside the housing, although surface
texturing on the outside can still be desirable to facilitate
gripping. The insertion of flexible insert 132 into housing 122
forms cleaning tool 150, which can then be impregnated or at least
partially saturated with a composition as previously described that
is suitable for use in cleaning and disinfecting a frontal
attachment. A slit 140 can be provided in facing surface 136 of
flexible insert 132 and continuing upward to continuous web 144 to
create opposed facing surfaces 142 that permit the insertion of
frontal attachment 152 into cleaning tool 150 as shown in FIG. 26.
As shown, frontal attachment 152 is a CLAVE.RTM. connector attached
to tubing segment 158. The forwardly extending threaded portion of
frontal attachment 152 is desirably cleaned by manipulating
cleaning tool 150 up and down as indicated by opposed arrows 156,
and by manually rotating cleaning tool 150 relative to frontal
attachment 152.
[0078] Another preferred embodiment of the invention is disclosed
in relation to FIG. 27. According to this embodiment of the
invention, cleaning tool 160 is shown in relation to frontal
attachment 194 attached to tubing segment 196. Cleaning tool 160
preferably further comprises a housing 186 containing a flexible
insert 188, and has an attached polymeric handle 162 with flexible
side walls, a closed end 164 and a hollow interior cavity with an
open end 166 that is in fluid communication with flexible insert
188. Frangible ampule 180 or another similarly effective fluid
reservoir is desirably disposed inside handle 162 and preferably
contains an amount of cleaning and disinfecting fluid 182 that is
sufficient to partially saturate flexible insert 188 and
effectively clean and disinfect the exposed free end of frontal
attachment 194. Lever arm 168 with blunt edge 170 is desirably
provided on the outside of handle 162 to facilitate the selective
application of manual force against the side wall of handle 162,
causing it to flex sufficiently to cause fracturing of the
relatively rigid sidewalls of ampule 180, thereby releasing
cleaning and disinfecting fluid 182 to flow downwardly by gravity
into flexible insert 188.
[0079] Referring to FIGS. 28-34, according to another preferred
embodiment of the invention, a tool 200 for contacting and/or
applying a fluid to attachment surfaces of fluid connector devices
used in medical applications is provided that comprises a generally
cylindrical housing 202 having two distinct cavities with open ends
and with an opening 228 establishing fluid communication between
them. A flexible insert 204 is desirably secured to the inside wall
of the forwardly facing cavity by use of an adhesive or other
similarly effective means. Substantially cylindrical fluid
receptacle 212 having a closed rearwardly facing end and an open
forwardly facing end sealed with a removable stopper 216 slidably
engages the open end of the upper cavity. Fluid receptacle 212 is
preferably made of plastic but, alternatively, can be made of a
different material, such as glass. Removable stopper 216 is
preferably made of a rubber but, alternatively, can be made of
another similarly effective polymeric material, cork, or a
rupturable membrane that is substantially impermeable to the liquid
contained in receptacle 212. Housing 202 and fluid receptacle 212
are desirably cooperatively configured so that an application of
manual force against the closed, rearwardly facing end of
receptacle 212 will cause stopper 216 to be dislodged from the
opening at the lower end upon contact with prongs 230, 232, which
can be of the same or different lengths. When stopper 216 is
dislodged, a cleaning and disinfecting fluid 220 stored in the
receptacle can flow through opening 228 between the two cavities of
housing 202 to saturate flexible insert 204 prior to contacting the
insert with the frontal attachment to be cleaned. A removable
flexible seal or cover 206 is desirably provided over flange 208 at
the open end of the forwardly facing cavity of housing 202 to
prevent inadvertent contamination of flexible insert 204 prior to
use.
[0080] Referring particularly to FIGS. 31-33, prongs 230, 232 or
one or more other similarly effective structural members are
desirably provided in the rearwardly facing cavity of housing 202
to assist in dislodging stopper 216 from its normal sealing
position across the opening at the bottom of fluid receptacle 212
when receptacle 212 is moved forwardly relative to housing 202. The
use of one longer prong 230 at one side of stopper 216 is
particularly preferred because it concentrates the manual force
being applied downwardly on receptacle 212 on a limited area to
assist in dislodging stopper 216 to release cleaning and
disinfectant 220 to flow through opening 228 into the porous,
spongy flexible insert 204. When two or more prongs 230, 232 are
used, a combination of one longer prong with the remainder of the
prongs being spaced apart circumferentially and slightly shorter
than the first will help maintain stopper 216 in a nearly
horizontal position, thereby causing stopper 216 to function as a
piston that will help force released liquid that has moved past
stopper 216 through opening 228 and into flexible insert 204.
[0081] Referring particularly to FIGS. 29 and 31-34, according to a
particularly preferred embodiment of the invention, structure is
provided that prevents fluid receptacle 212 from being depressed
relative to housing 202 prematurely, thereby causing stopper 216 to
be dislodged from the opening at the bottom end of receptacle 212,
until such time as it is desired to saturate flexible insert 204.
The rear cavity of housing 202 preferably further comprises two
parallel, longitudinally extending slots 222, 224 that cooperate
with lug 214 on the lower circumference of receptacle 212 to allow
receptacle 212 to be fully depressed only when lug 214 of
receptacle 212 is rotationally aligned with longer channel 224.
This is desirably achieved by rotating receptacle 212 slightly
while grasping housing 202 with the other hand to reposition lug
214 from alignment with channel 222 into alignment with longer
channel 224.
[0082] Referring to FIGS. 35 and 36, a cleaning tool 200' is
disclosed that is in all respects like that previously described in
relation to FIGS. 28-34 except that it has only a single
longitudinally extending slot 224 and does not include shorter slot
222 as described in relation to the embodiment of FIGS. 28-34.
Accordingly, receptacle 212 is not rotatable relative to housing
202, and the tool is activated by forcing receptacle 212 toward
prongs 230, 232 until closure 216 is displaced, allowing fluid 220
to flow into flexible insert 204. Cleaning tool 200' is then ready
for use when flexible seal or cover 206 is removed.
[0083] Referring to FIGS. 37-43, another preferred embodiment of
the invention is disclosed wherein cleaning tool 252 comprises a
unitary housing with upper and lower sections 254, 256,
respectively. Upper section 254 defines cavity 258 having a closed
end 260 and an open end defined by annular collar 264. Collar 264
preferably has tapered shoulders 282, 283 (seen in FIG. 42) to
facilitate introduction and removal of a tool during molding of the
housing, and to facilitate placement and removal of closure 270.
Lower section 256 comprises cavity 262 having a bottom opening with
an annular flange 266 that further comprises an annular recess 268.
Housing 252 is desirably unitarily molded from any suitable
polymeric resin and is then inverted to introduce cleaning and/or
disinfecting liquid 274 into cavity 258. Because liquids are
substantially incompressible, sufficient headspace should be left
unfilled in cavity 258 to permit the subsequent disengagement of
closure 270 from collar 264 as described below.
[0084] After liquid 274 is in place inside cavity 258, removable
closure 270 is desirably installed to seal the opening defined by
annular collar 264. Removable closure 270 is preferably made of an
elastomeric or compressible polymeric material to provide a
fluid-tight seal when engaged with annular collar 264. Although the
use of a removable closure is preferred, it should be understood
that any similarly effective means for sealing liquid 274 into
cavity 258 can likewise be used provided that it can be perforated,
dislodged or otherwise modified to permit the release of liquid 258
prior to use of tool 252. Following installation of closure 270,
flexible insert 276 is desirably inserted into cavity 262 of lower
section 256, and is attached to the inside wall of lower section
256 by heat-staking or by other known attachment methods that will
serve to resist rotation of the outside wall of flexible insert 276
inside lower section 256.
[0085] Flexible insert 276 is preferably made from a cellular
polymeric material having sufficient porosity or liquid-retaining
capability to receive and hold liquid 274 flowing into cavity 262
from cavity 258 following displacement of closure 270, and also
having the ability to release or discharge liquid 274 onto an
attachment surface of a fluid connector with which flexible insert
276 is placed in contact during use of cleaning tool 252. As shown
in FIGS. 39 and 40, flexible inert 276 preferably further comprises
a cylindrical recess 278 that is configured to receive the
attachment end of a fluid connector device for cleaning and/or
disinfecting during use of tool 252. Flexible insert can be held in
place by a retainer ring 280 insertable into annular recess 268,
although the use of such a retainer ring is not required if
flexible insert 276 is attached to the inside of lower section 256
as previously described. Although not shown in FIG. 29, it will be
appreciated that a seal or cover as previously described in
relation to cover 206 of FIGS. 32-34, 36 is desirably applied
across the open end of lower section 256 following assembly of tool
252 as described above. Such a seal or cover will maintain the open
end of tool 252 in a sanitary condition until removed just prior to
use, and can be conveniently attached by pressure-sensitive
adhesive or the like to the underside of flange 266. Where tool 252
is entirely packaged inside a sanitary wrap, the use of another
seal or cover across the opening of lower section 256 is not
needed.
[0086] To use cleaning tool 252, following removal of the sanitary
wrap or cover, the free end of the fluid connector device having
the attachment surfaces to be cleaned is desirably inserted into
recess 278 of flexible insert 276, and is forced upwardly, causing
the upper surface of flexible insert 276 to contact prongs 272 of
closure 270, best seen in FIGS. 38 and 41. The continued
application of upwardly directed force to the fluid connector will
displace closure 270, thereby releasing cleaning and/or
disinfecting fluid 274 downwardly into flexible insert 276. The
configuration of prongs 272 and the material used to make them are
desirably such that they will transmit to the body of closure 270
enough force to displace closure 270 from the opening defined by
annular collar 264. Alternatively, closure 284 having a single
projection 286 with a slightly stepped-in diameter relative to body
288 can be substituted for closure 270 if desired.
[0087] Referring to FIGS. 44-47, another cleaning tool 300 is
disclosed that is made similarly to tool 252 of FIGS. 37-42, but
utilizes a stopper 314 made as shown in FIG. 43. Tool 300 comprises
housing 302 with upper section 304 having a closed end 306, and a
lower section 308 having annular flange 310 at its base, and an
annular recess 324 inside flange 310. In this embodiment, flexible
insert 320 is made as shown in FIG. 47, with a larger-diameter base
338 and a transverse slit 322 extending upwardly into, but not
through the top of body section 340. Referring to FIG. 46, when
flexible insert 320 is made with a slit 322 instead of a recess 278
as shown in FIG. 39, attachment surfaces such as threads 336 of
fluid connector 328, here attached to a fluid flow line 334, can be
forced upwardly into slit 322, causing top surface 332 to contact
and displace closure 314. This in turn allows cleaning and/or
disinfecting liquid 316 as previously described to flow downwardly
as indicated by arrows 330 to saturate flexible insert 320.
Attachment surfaces 336 of fluid connector 328 are then cleaned by
moving tool 300 both axially and rotationally in relation to fluid
connector 328.
[0088] Referring to FIG. 48, cleaning tool 350 is another
embodiment of the invention wherein a flexible insert 362 made as
described in relation to FIGS. 44-47. In this embodiment, housing
352 has substantially parallel inside and outside walls that
continue from flange 356 to closed end 354 of the upper cavity.
Annular collar 358 is desirably made substantially as described in
relation to FIG. 42 to facilitate insertion and removal of a core
pin in the molding tool (not shown) and to facilitate installation
and displacement of closure 360. In this embodiment, fluid 364 must
again have sufficient headspace to allow displacement of closure
360. However, where closure 360 is a membrane that is ruptured,
torn or perforated, little if any headspace is required.
[0089] It will be appreciated that the cleaning tools of the
invention are desirably packaged and sterilized so that they will
remain sterile until removed from the packages immediately prior to
use. Desirably, where the cleaning tool is shipped and stored with
a flexible insert that is already at least partially saturated with
a cleaning and disinfecting fluid, a barrier material should be
used as part of the packaging treatment to insure that the fluid
does not evaporate prior to use.
[0090] Other alterations and modifications of the invention
disclosed herein will likewise become apparent to those of ordinary
skill in the art upon reading this disclosure, and it is intended
that the scope of the invention be limited only by the broadest
interpretation of the appended claims to which the inventors are
legally entitled.
* * * * *