U.S. patent application number 13/466976 was filed with the patent office on 2012-08-30 for medical implement cleaning device.
Invention is credited to Paul Diperna, Bobby E. Rogers.
Application Number | 20120216360 13/466976 |
Document ID | / |
Family ID | 39650495 |
Filed Date | 2012-08-30 |
United States Patent
Application |
20120216360 |
Kind Code |
A1 |
Rogers; Bobby E. ; et
al. |
August 30, 2012 |
Medical Implement Cleaning Device
Abstract
A cleaning device for a medical implement is disclosed. The
cleaning device includes a cap having an opening to an inner
cavity, the opening being adapted to receive a site of the medical
implement. The cleaning device further includes a compressible
cleaning material that contains a cleaning agent prior to receipt
of the site of the medical implement, i.e. the cleaning material is
pre-loaded with the cleaning agent. The compressible cleaning
material is at least partially secured in the inner cavity and
adapted to swab and clean the site with the cleaning agent.
Inventors: |
Rogers; Bobby E.; (San
Diego, CA) ; Diperna; Paul; (San Clemente,
CA) |
Family ID: |
39650495 |
Appl. No.: |
13/466976 |
Filed: |
May 8, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13189457 |
Jul 22, 2011 |
8206514 |
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13466976 |
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12860825 |
Aug 20, 2010 |
7985302 |
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13189457 |
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11705805 |
Feb 12, 2007 |
7780794 |
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12860825 |
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60832437 |
Jul 21, 2006 |
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60850438 |
Oct 10, 2006 |
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Current U.S.
Class: |
15/104.93 |
Current CPC
Class: |
A61B 90/70 20160201;
A61M 39/162 20130101; A61L 2/18 20130101 |
Class at
Publication: |
15/104.93 |
International
Class: |
B08B 1/00 20060101
B08B001/00 |
Claims
1. A cleaning device for a medical implement, the cleaning device
comprising: a cap having an inner cavity; a cleaning material
disposed within the inner cavity and preloaded with a cleaning
agent, the cleaning material comprising a plurality of
independently compressible cleaning material members to swab and
clean portions of the site of the medical implement with the
cleaning agent; an opening to the inner cavity for receiving the
site of the medical implement at least partially into the inner
cavity to contact the site with one or more of the plurality of
independently compressible cleaning material members; and a
removable seal attached to the cap at the opening to cover the
opening and to maintain the cleaning material and the cleaning
agent within the inner cavity prior to receipt of the site of the
medical implement.
2. The cleaning device in accordance with claim 1, wherein at least
one of the plurality of independently compressible cleaning
material members is compressible axially against the site of the
medical implement.
3. The cleaning device in accordance with claim 1, wherein at least
one of the plurality of independently compressible cleaning
material members is compressible radially against the site of the
medical implement.
4. The cleaning device in accordance with claim 2, wherein at least
one other of the plurality of independently compressible cleaning
material members is compressible radially against the site of the
medical implement.
5. The cleaning device in accordance with claim 3, wherein at least
one other of the plurality of independently compressible cleaning
material members is compressible axially against the site of the
medical implement.
6. The cleaning device in accordance with claim 1, wherein the
cleaning material includes an open-cell foam.
7. The cleaning device in accordance with claim 1, wherein the
cleaning agent includes isopropyl alcohol.
8. A medical implement cleaning cap comprising: a housing that
defines an inner cavity; a cleaning material held within the inner
cavity and at least partially saturated with a cleaning agent, the
cleaning material comprising a plurality of independently
compressible cleaning material members to swab and clean portions
of a site of the medical implement with the cleaning agent; an
opening in the housing to the inner cavity for receiving a site of
the medical implement at least partially into the inner cavity to
contact the site of the medical with one or more of the plurality
of independently compressible cleaning material members; and a
removable seal that encloses the housing to retain the cleaning
agent in the cleaning material and prevent evaporation of the
cleaning agent prior to removal of the seal.
9. The medical implement cleaning cap in accordance with claim 8,
wherein the plurality of independently compressible cleaning
material members are adapted to swab and clean a portion of the
site using axial compression and/or radial compression against a
portion of the site of the medical implement.
10. The medical implement cleaning cap in accordance with claim 8,
wherein the removable seal includes a foil attached to the opening
in the housing.
11. The medical implement cleaning cap in accordance with claim 8,
wherein the cleaning material includes a foam.
12. The medical implement cleaning cap in accordance with claim 8,
wherein the cleaning agent includes isopropyl alcohol.
13. The medical implement cleaning cap in accordance with claim 8,
wherein the housing includes an outer surface having a plurality of
vertical ridges perpendicular to a plane of the opening of the
housing.
14. A medical implement cleaning cap comprising: a housing that
defines an inner cavity; a cleaning material held within the inner
cavity, the cleaning material comprising a plurality of
independently compressible cleaning material members to swab and
clean portions of a site of the medical implement with a cleaning
agent that at least partially saturates the cleaning material; an
opening in the housing to the inner cavity for receiving a site of
the medical implement at least partially into the inner cavity to
contact the site of the medical with one or more of the plurality
of independently compressible cleaning material members; and a
removable seal that encloses the housing to maintain the cleaning
material and the plurality of independently compressible cleaning
material members within the inner cavity prior to removal of the
seal.
15. The medical implement cleaning cap in accordance with claim 14,
wherein the plurality of independently compressible cleaning
material members are adapted to swab and clean a portion of the
site using axial compression and/or radial compression against a
portion of the site of the medical implement.
16. The medical implement cleaning cap in accordance with claim 14,
wherein the removable seal includes a foil attached to the opening
in the housing.
17. The medical implement cleaning cap in accordance with claim 14,
wherein the cleaning material includes a foam.
18. The medical implement cleaning cap in accordance with claim 14,
wherein the cleaning agent includes isopropyl alcohol.
19. The medical implement cleaning cap in accordance with claim 14,
wherein the housing includes an outer surface having a plurality of
vertical ridges perpendicular to a plane of the opening of the
housing.
20. A medical implement cleaning cap comprising: a housing that
defines an inner cavity; a cleaning material held within the inner
cavity, the cleaning material comprising a plurality of
independently compressible cleaning material members to swab and
clean portions of a site of the medical implement; an opening in
the housing to the inner cavity for receiving a site of the medical
implement at least partially into the inner cavity to contact the
site of the medical implement with one or more of the plurality of
independently compressible cleaning material members; and a
removable seal that encloses the housing to hold the cleaning
material and the plurality of independently compressible cleaning
material members within the inner cavity prior to removal of the
seal.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 13/189,457 filed on Jul. 22, 2011, entitled,
"Medical Implement Cleaning Device," which is a continuation of
U.S. patent application Ser. No. 12/860,825 filed on Aug. 20, 2010,
issued on Jul. 26, 2011 as U.S. Pat. No. 7,985,302, and entitled
"Medical Implement Cleaning Device," which is a continuation of
U.S. patent application Ser. No. 11/705,805 filed on Feb. 12, 2007,
issued on Aug. 24, 2010 as U.S. Pat. No. 7,780,794, and entitled
"Medical Implement Cleaning Device," which claims the benefit under
35 U.S.C. .sctn.119(e) of U.S. provisional patent application Ser.
No. 60/832,437 filed on Jul. 21, 2006 and entitled "Disinfecting
Cap" and also claims the benefit under 35 U.S.C. .sctn.119(e) of
U.S. Provisional patent application Ser. No. 60/850,438 filed on
Oct. 10, 2006 and entitled "Disinfecting Cap." The disclosures of
all applications to which the current application claims priority
are incorporated by reference herein in their entireties.
BACKGROUND
[0002] Within the medical field, and in particular the area of
infusion of fluids or aspiration of fluids to or from a patient,
there is a need to prevent the transmission of pathogens into or
onto a patient from a potentially contaminated surface of a medical
implement, or "site". Such pathogens include microorganisms such as
bacteria and viruses. The transmission of pathogens into a patient
may result in an infection that could be life threatening. Specific
to healthcare settings, the term "nosocomial infection" describes
those infections that originate from or occur in a hospital or
hospital-like setting. In the U.S., nosocomial infections are
estimated to occur in at least 5% of all acute care
hospitalizations. The estimated incidence is more than two million
cases per year, resulting in an added expenditure in excess of $4.5
billion. Nosocomial infections are estimated to more than double
the mortality and morbidity risks of any admitted patient, and
likely result in about 90,000 deaths a year in the United States.
Common sites for such transmissions are found on such medical
implements as a luer port, vial, needle free valve, or an injection
port of a vessel, tubing, or catheter. Even non-intrusive medical
implements such as stethoscopes can transmit pathogens to a
patient. The incidence of infection in patients is presently
numerous and increasing, and Infection Control Practitioners
(ICP's) often cite improper cleaning of sites as a major source of
these infections.
[0003] Traditionally, cleaning a potentially contaminated surface
includes a protocol of alcohol swabbing prior to making the
necessary connections to the site. Today alcohol swabs, a small pad
of cotton gauze soaked in isopropyl alcohol, are packed
individually in a foil package. The foil package is relatively
inexpensive, and is used to retain the alcohol within the package
and to prevent evaporation. Properly used, the package is opened at
or near the site to be swabbed. With gloved hands, the pad is
removed by a healthcare provider and wiped across the top and side
surfaces of the site, and the pad and foil package are discarded.
The site should be allowed to dry, usually twenty to thirty
seconds, immediately prior to making any connection. This "drying"
period is important: when alcohol dries, it breaks open the
cellular walls of microorganisms, thereby killing them.
[0004] Unfortunately, because of increased duties and
responsibilities, shrinking nursing staffs, and inadequate
training, swabbing is often overlooked or is poorly executed. A
poorly swabbed site can carry microorganisms that, if allowed to
enter a patient's body, can cause serious infection. In addition,
supervisory oversight is nearly impossible, because unless a
supervisor can actually observe the swabbing being performed, the
supervisor cannot know whether or not it was done properly or
performed at all. Further, without at least a sufficient
microscopic examination for microbial residue, there may be no
evidence of an alcohol swab being performed. Thus, a need exists
for an apparatus and technique for cleaning a site on a medical
implement prior to contact with a patient, and which will eliminate
technique-related issues and training issues, and provide an
unequivocal indicator that a site is clean prior to accessing a
patient's vascular system.
SUMMARY
[0005] A cleaning device, system and method for a medical
environment is disclosed. In one aspect, the cleaning device
includes a cap having an opening to an inner cavity, the opening
being adapted to receive a site of the medical implement. The
cleaning device further includes a compressible cleaning material
that contains a cleaning agent prior to receipt of the site of the
medical implement, i.e. the cleaning material is pre-loaded with
the cleaning agent. The compressible cleaning material is at least
partially secured in the inner cavity and adapted to swab and clean
the site with the cleaning agent.
[0006] In another aspect, a cleaning system for a threaded medical
implement includes a cap having an inner cavity and an opening to
receive a site of the medical implement into the inner cavity. The
system further includes a threaded ring connected to the inner
cavity at the opening to the cap, and having threads that
correspond to threads on the threaded medical implement. The system
further includes a cleaning material in the inner cavity adapted to
provide radial compression against the threaded medical implement,
the cleaning material containing a cleaning agent prior to receipt
of the site of the medical implement. The opening is preferably
covered by a removable vacuum seal.
[0007] In yet another aspect, a method of cleaning a site of a
medical implement includes the steps of at least partially
saturating a cleaning material with a cleaning agent in an inner
cavity of a cap; and contacting a top of the site of the medical
implement to a first portion of the cleaning material. The method
further includes steps of compressing the first portion of cleaning
material with the site of the medical implement to contact a side
of the site with a second portion of the cleaning material provided
around the first cleaning material, and attaching the cap over the
site of the medical implement.
[0008] In yet another aspect, a cleaning device for a medical
implement includes a cap having an opening to an inner cavity, an
inner surface of the opening including one or more threads adapted
to receive a site of the medical implement. The cleaning device
further includes a cleaning material formed of a compressible
material that is at least partially secured in the inner cavity,
the cleaning material containing a cleaning agent.
[0009] In still yet another aspect, a cleaning system for a medical
environment includes a plurality of caps. Each cap includes an
inner cavity and an opening to receive a site of the medical
implement into the inner cavity, and a cleaning material in the
inner cavity adapted to provide radial compression against a site
of a medical implement, the cleaning material containing a cleaning
agent prior to receipt of the site of the medical implement. The
system further includes a seal that covers the opening of each of
the plurality of caps, and from which individual ones of the
plurality of caps can be selectively removed to be used for
cleaning the site of the medical implement.
[0010] The details of one or more embodiments are set forth in the
accompanying drawings and the description below. Other features and
advantages will be apparent from the description and drawings, and
from the claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] These and other aspects will now be described in detail with
reference to the following drawings.
[0012] FIG. 1 is a cross-sectional, exploded view of a cleaning
device.
[0013] FIG. 2 is a cross-sectional view of an assembled cleaning
device.
[0014] FIG. 3 illustrates operation of a cleaning device for
connection to a site of a medical implement.
[0015] FIG. 4 illustrates a cleaning device connected to a medical
implement and cleaning a site of the medical implement.
[0016] FIG. 5 shows another embodiment of an assembled cleaning
device.
[0017] FIG. 6 is a cross-sectional view of an assembled cleaning
device in accordance with an embodiment.
[0018] FIG. 7 is a perspective view of another cleaning device.
[0019] FIG. 8 is a cross section of a cleaning device.
[0020] FIGS. 9 and 10 show a cleaning device being used to clean a
site of a medical implement.
[0021] FIG. 11 is a perspective view of a ring that attaches to a
corresponding structure of a medical implement.
[0022] FIG. 12 is a cross sectional view of another alternative
embodiment of a cleaning device.
[0023] FIG. 13 shows yet another alternative embodiment of a
cleaning device.
[0024] FIG. 14 shows a cap of a cleaning device in accordance with
some embodiments.
[0025] Like reference symbols in the various drawings indicate like
elements.
DETAILED DESCRIPTION
[0026] In accordance with preferred embodiments, a cleaning device
includes a cap having a shape and/or external features to promote
easy gripping and a cleaning material in the cap that holds or is
in contact with a cleaning agent, such as isopropyl alcohol, for
application of the cleaning agent to a site of a medical
implement.
[0027] The cleaning material can be any substance that can conform,
mold or compress in a manner that enables the effective wiping of
the site, including the top surface of the site, side surface, and
any threads or grooves, if present, and provide the cleaning agent
at least at a surface level. Examples of the cleaning material
include cotton, open or closed cell foam such as polyethylene foam,
or other substance that can hold or carry the cleaning agent. The
cleaning agent can be any chemical, substance or material that
cleans the site of bacterial or even viral microorganisms, or any
carrier that contains such chemical, substance or material.
Examples of a cleaning agent include isopropyl alcohol,
chlorhexidine, povidone-iodine, hydrogen peroxide, soap, and
hydrochloric acid.
[0028] The term "medical implement" is used to denote any tool or
object that can be used in a medical setting and that can connect
to a site cleaning device as described herein according to a number
of embodiments. Examples of medical implements include, but are not
limited to, access ports on tubing sets (extension sets,
T-connectors and IV sets), access ports on catheters (both
peripheral and central lines), needle free valves, stopcocks, luer
connectors, stethoscopes and other components or devices whereby
regular cleaning is desired. Medical implements are commercially
available in standard sizes. Thus, the end or opening of a site
cleaning device can be provided with fittings to accommodate such
standard size medical implements.
[0029] The cap of the cleaning device is made of a material that is
compatible with the cleaning materials and agents to be used,
examples of materials would include, sealed foam, plastic, glass,
or metal. The cleaning device may need to undergo sterilization.
For securing the cleaning device to another device, the cleaning
device can include attachment mechanisms such as "snap-fit"
mechanisms or clamps to hold it in place on the other device.
Alternatively the cleaning material in the cap may conform to the
sides of the medical implement to thereby "grip" and remain secured
to the medical implement. The cap also may have threading to secure
it in place on a medical implement. The cap may have some cutaway
portions on its walls to enable the use of some undercuts during
the molding process, and to allow the cleaning material to flex
outward both during use. The cap can be made from polyethylene or
another material that is stable when in the presence of alcohol or
other cleaning agent.
[0030] In preferred exemplary embodiments, prior to being applied
to a site, and after the cleaning material is provided with a
cleaning agent, the opening of the cap is sealed with a foil-based
seal or other material suitable for retaining a cleaning agent in
the cleaning material and preventing evaporation of the cleaning
agent. The cap seal may also be formed in a manner whereby several
caps could be attached i.e. a strip, where individual caps can be
peeled from the strip in order to be used. These strips of caps can
be made conveniently accessible, i.e. hung from intravenous (IV)
poles or IV sets, in patient rooms and medication carts, to name
just a few. The strips provide the convenience of having several
caps available in one location.
[0031] The cleaning material in the cap can be an alcohol-soaked
piece of gauze, foam or similar cleaning material. The cleaning
material can be formed into the general interior shape of the cap
from one or more pieces. For instance, the cleaning material can
include a ring for circumscriptive coverage and cleaning of the
site, and further include a cylinder within the ring for coverage
and cleaning on a distal end of the site. A single piece of
cleaning material may also be cut or formed to perform the same
coverage and cleaning functions as the two pieces described above.
The cleaning material may also cover the threads and/or be formed
as part of the threads.
[0032] In still further embodiments, the cleaning material may be
made entirely or partially of the cleaning agent. For example, the
cleaning material can be formed of an open cell foam or plastic
that is chemically or physically impregnated with a cleaning agent
such as povidone or iodine, or isopropyl alcohol.
[0033] To further illustrate and describe these concepts, reference
is now made to FIG. 1, which shows a cross-sectional, exploded view
of a cleaning device, embodied as a cap 10 with a housing 4 that
defines an inner cavity 20 of the cap 10. A foil seal 1 is
configured to attach to a sealing surface 2 of the housing 4. The
housing 4 further includes internal threads 3. In a preferred
exemplary embodiment, the internal threads 3 are sized and arranged
to accommodate luer threads, i.e. standardized male threads
designed to mate with the female threads on a medical implement to
which the cap 10 attaches. The housing 4 also has a mating surface
5 for attachment of a bottom portion 6.
[0034] Within housing 4 is a first cleaning material 7. The first
cleaning material 7 may be attached to the walls of housing 4 by
glue, solvent or some other attachment composition or mechanism, or
may be held in the housing 4 by compression or trapped between the
bottom portion 6 and housing 4. Ribs or protrusions on the inside
of the housing 4 may also be used to prevent the cleaning material
7 from slipping or rotating. The first cleaning material 7 is
compressible, and is preferably doughnut-shaped or ring-shaped. The
first cleaning material 7 is positioned and configured to compress
radially in an outwardly direction to scrub or wipe the
circumscriptive surface of the site and the surface of the threads
of an inserted medical implement.
[0035] A second cleaning material 8 is designed to compress in the
axial direction upon insertion of the medical implement and is
designed to wipe the distal end and distal surface of the inserted
medical implement. The second cleaning material 8 may be attached
to the walls of bottom portion 6 by glue, solvent or some other
attachment composition or mechanism, or affixed to first material 7
by glue, solvent or some other attachment composition or mechanism.
Protrusions on the inside of the bottom portion 6 may also be used
to prevent the cleaning material 8 from rotating or removal. The
first cleaning material 7 and second cleaning material 8 may be
formed from a single piece of compressible cleaning material of
cotton, foam or other suitable cleaning material adapted for
scrubbing. This single piece may be cut completely or partially cut
to achieve a similar effect as two separate pieces of cleaning
material.
[0036] FIG. 2 illustrates an assembled cap 10. The first and second
cleaning materials 7 and 8 in the inner cavity 20 are at least
partially saturated with a cleaning agent, such as isopropyl
alcohol, or a mix of cleaning agents. The foil seal 1 is then
attached to housing 4 at sealing surface 2 by glue, solvent,
thermal bonding, etc. A bottom portion 6 is attached to housing 4
at point 5 by glue, welding, solvent, threads or other attachment
mechanism or process. With the foil seal 1 and the bottom portion 6
attached to housing 4, the inner cavity 20 is hermetically sealed.
The housing 4, bottom portion 6, and first and second cleaning
materials 7, 8 are respectively made of a material or cleaning
materials that are compatible with the cleaning agent. For
instance, if isopropyl alcohol is used for at least part of the
cleaning agent, the housing 4 and bottom portion 6 can be
constructed of a plastic such as polyethylene. The housing 4 and
bottom portion 6 can be formed of a unitary piece of material, as
explained further below.
[0037] FIG. 3 illustrates a medical implement 30 moving toward
housing 4, in a direction A, which should be recognized as a
reference only, and that the housing 4 can likewise be moved toward
the medical implement 30. The foil seal 1 is removed from housing
4. In alternative embodiments, the foil seal 1 can be a foil pouch
or other sterilized material that would inhibit evaporation of the
cleaning agent. A distal end surface 12 of the medical implement 30
is eventually contacted with the upper surface 50 of the second
cleaning material 8.
[0038] As the medical implement 30 continues in direction A, it
axially compresses second cleaning material 8 continuing to clean
surface 12 with surface 50. This movement also begins to radially
compress the first cleaning material 7 and to conform the first
cleaning material 7 with, and begin scrubbing, threads 11. The
cleaning materials 7 and 8 contain the cleaning agent so as to
perform a thorough cleaning of the area about the threads 11 and
the surface 12. As threads 11 of the medical implement 30 continue
to be rotationally inserted into the threads 3 of the housing, the
distal end surface 12 is automatically scrubbed by surface 50 of
the second cleaning material 8 and cleaned by cleaning agent held
therein, and at least a portion of the side and threads 11 of the
medical implement 30 are automatically scrubbed by radial
compression of the first cleaning material 7 and cleaned by a
cleaning agent held therein. FIG. 4 illustrates the disinfecting
cap 10 with a fully inserted medical implement 30.
[0039] The cap 10 can be removed immediately from the medical
implement 30 after use, or be kept in place. If the cap 10 is
removed the medical implement 30 surfaces 11 and 12 will be clean
and ready for use upon the drying of the cleaning agent. If the cap
10 is kept secured to medical implement 30, the cleaning agent in
cap 10 will evaporate over time thereby destroying any
microorganisms on the surfaces 12 and 11 of medical implement 30.
The cap 10 then maintains the surfaces 11 and 12 of medical
implement 30 in a clean and ready-to-access state by eliminating
any forms of touch contamination.
[0040] FIGS. 5-10 illustrate an alternate embodiment of a cleaning
device 100. FIG. 5 is a perspective view of the cleaning device 100
formed of a cap 102 with a seal 104 that is connected to and covers
the opening of the cap 102. The cap 102 can have a number of
gripping ridges or projecting members for ease of use. FIG. 6 is a
cross-sectional view of the cleaning device 100. The cap 102 forms
an inner cavity with one opening that is large enough to receive a
site of a medical implement. The seal 104 is affixed to the opening
and is preferably entirely removable. In other embodiments, the
seal 104 is permanently affixed, and is simply punctured by
insertion of a site of a medical implement.
[0041] The cap 102 houses a threaded ring 106 proximate to the
opening. The threaded ring 106 includes one or more threads 105 and
is adapted to receive the site of the medical implement to be
disinfected, and thus defines the size and shape of the opening.
This embodiment is advantageous because it creates a single
circumferential seal point, seal 104 to the opening of cap 102.
[0042] In some embodiments, the cap 102 and threaded ring 106 are
formed of a unitary piece of material or cleaning material. In
other embodiments, the threaded ring 106 fits into a groove 109
that is formed in the inside edge surface of the cap 102 near the
opening. In this latter configuration, the groove 109 maintains the
position of threaded ring 106 near the open end of the cap where
the threaded ring top surface may be flush with or slightly
recessed from the cap open end walls, and the threaded ring 106 may
also include or create with the cap wall a small vent aperture or
opening to allow evaporation of a cleaning agent in the cap 102.
The threaded ring 106 can be mechanically kept from rotating with
internal ribs or protrusions in cap 102 or groove 109. Threaded
ring 106 may be held in place within grove 109 and cap 102 by glue,
welding, snap-fit, solvent bonding or any other mechanism or
composition known to those of requisite skill.
[0043] The cleaning device 100 further includes a first cleaning
material 107 that holds the cleaning agent, such as isopropyl
alcohol, and a second cleaning material 108 that also holds or is
at least partially saturated by the cleaning agent. In preferred
exemplary embodiments, the first cleaning material 107 is formed as
a hollow cylinder or ring positioned between the threaded ring 106
and the top inside surface of the cap 102, and is adapted for
radial compression against a site that is inserted into the cap 102
or over which the cap 102 is placed. In some embodiments, the
second cleaning material 108 is formed as a solid cylinder and
positioned within the hollow space of the first cleaning material
107, and is adapted for axial compression against a leading edge of
the site that is inserted into the cap 102 or over which the cap
102 is placed. In other embodiments, cleaning materials 107 and 108
can be made of a single piece of material and cut or formed so as
to achieve the same result as described above. The cleaning agent
is provided to the cleaning materials 107, 108 prior to the opening
being covered with the seal 104.
[0044] FIG. 7 is a bottom perspective view and FIG. 8 is a
cross-sectional view of the cleaning device 100 with the seal 104
removed, showing the cap 102, threaded ring 106 that sits within
the cap 102, and the second cleaning material 108 inside the cap
102. The second cleaning material 108 can extend to and slightly
beyond the opening of the cap 102. FIG. 8 further shows the first
cleaning material 107 that circumscribes the second cleaning
material 108 and being positioned between the threaded ring 106 and
the top inner surface of the cap 102. FIG. 11 illustrates an
example of the threaded ring 106 and its threads 105. An attribute
of this embodiment of the threaded ring 106 shown in FIG. 11 is
that there are only two opposing threads that travel 180 degrees
before terminating. This enables the molding of threaded ring 106
without the use of a screw to create the thread feature in an
injection molding tool. The threaded ring 106 can also be produced
with an injection molding tool utilizing a screw.
[0045] FIG. 9 illustrates the cleaning device 100 about to make
contact with a site 120 of a medical implement. As discussed above,
the site 120 can be a luer port, a, a needle free valve, an
injection port of a vessel, or other medical implement that needs
to be cleaned prior to use with a patient. In some embodiments, the
site 120 can include a set of threads 122 that correspond to the
threads 105 in the threaded ring 106 of the cleaning device 100.
The cleaning materials 107 and 108 are preloaded with a cleaning
agent, before removal of the seal and contact by the site 120.
Accordingly, as shown in FIG. 10, the site 120 makes contact with
the cap 102 by a screwing motion relative to the cap 102. The
second cleaning material 108 is compressed axially and swabs
against the leading edge of the site 120, while the first cleaning
material 107 is compressed radially and swabs against sides of the
site 120.
[0046] FIG. 11 illustrates the molded thread ring 106 with two
opposing threads 105 that traverse opposing 180 degree portions of
the ring. This design enables the thread ring 106 to be molded
without the use of a screw that is typically used to create
threaded parts in a molding process. Thus the threaded ring 106 can
be manufacture very inexpensively. The threaded ring 106 can also
clean some of the threads when the cap is placed into position, and
may or may not cover all the threads. In some embodiments, the
threaded ring 106 can be molded from the cleaning material, or the
cleaning material is formed only of the threaded ring 106. In such
embodiments, the cleaning may only occur on threads of the site and
in an axial direction.
[0047] FIG. 12 shows an alternative embodiment of a cleaning device
130 having a cap 132 that is filled with a cleaning material. The
cap 132 has side walls 134 and a top 136 that define an inner
cavity with an opening 132. The cleaning material includes at least
a first cleaning material 138, such as cotton or foam, that
delivers a cleaning agent. The cleaning material can include a
second cleaning material 140 to hold more cleaning agent. In some
embodiments, the second cleaning material 140 can be circumscribed
by the first cleaning material 138. Alternatively, the first
cleaning material 138 can completely envelope the second cleaning
material 140, each providing their own compressibility and capacity
to hold a cleaning agent. Still, in other embodiments, the first
and second cleaning materials 138, 140 can be formed of a single
piece of material. The cleaning material(s) are filled at least
partially with a cleaning agent, prior to sealing of the opening
132 with a seal and closure of the inner cavity.
[0048] FIG. 13 shows an alternate embodiment of a cleaning device
150. In this embodiment, the cleaning device 150 includes a housing
152 that is formed as a threaded cap. The inner surface of the
housing 152 is covered, at least in part, by a cleaning layer 154
that is bonded to the inner surface of the housing 152. The
cleaning layer 154 can be a cleaning material such as cotton, foam,
or other porous and pliable material that suitably holds and/or
delivers a cleaning agent such as isopropyl alcohol. The cleaning
layer 154 is sized and positioned inside the housing 152 so as to
be able to swab the top and a portion of the sides of a part of a
medical implement that is inserted therein, or over which the
housing 152 is placed. Accordingly, the cleaning layer 154 can have
any thickness or compressibility.
[0049] FIG. 14 shows yet another alternative embodiment of a
cleaning device 160, illustrating an outer view of a rounded
housing 162 for an expanded inner chamber to hold more cleaning
agents or cleaning materials that hold such agents. Holes 164 in
the housing 162 can promote evaporation of the cleaning agent,
particularly when the housing covers a site of a medical implement
to be disinfected. The location of the vent holes is variable and
the vent holes can also be sealed with a filter type membrane that
permits the drying of the cleaning agents but does not allow entry
of microorganisms or fluid.
[0050] The use of the various implementations and embodiments above
entails the following: the healthcare worker would, with gloved
hands, open the foil package and place this cap over the site of a
medical implement to be cleaned. Upon placement the alcohol soaked
cleaning material wipes all of the port's surfaces. This wipe could
be accomplished by either a turning motion (if threads are used) or
by simply pushing the cap onto the port. In this way the cap
eliminates errors in the practice of swabbing due to poor training
or excessive workloads. The cap would then remain secured in place
by threads, mechanical tension provided by the foam, cotton, etc.,
snaps or some other mechanism. A cap in place on a medical
implement is a positive indication that a desired site of the
medical implement is clean. A vibrant color may be used to allow
instant visualization of a cap's presence from a door or hallway.
ICP's can review compliance by merely observing sites to see
whether or not a cap is in place. The cap could remain in place for
periods of up to three days or more. For extended periods the
alcohol will likely evaporate, which assures that the site is
clean. With the cap in place, it continues to keep the site clean
even after the alcohol has evaporated.
[0051] Although a few embodiments have been described in detail
above, other modifications are possible. For instance, any of the
embodiments described above may be sized and scaled for a
particular medical implement, such as a stethoscope. Other
embodiments may be within the scope of the following claims.
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