U.S. patent application number 17/342630 was filed with the patent office on 2021-10-14 for capping and cleansing devices for needlefree vascular access connectors.
This patent application is currently assigned to CleanSite Medical, Inc.. The applicant listed for this patent is CleanSite Medical, Inc.. Invention is credited to Nicholas ANDERSON, Adam ARIELY, Daniel M. CHAMBERS, John GRANT, David G. MATSUURA, Philip J. SIMPSON.
Application Number | 20210316130 17/342630 |
Document ID | / |
Family ID | 1000005669266 |
Filed Date | 2021-10-14 |
United States Patent
Application |
20210316130 |
Kind Code |
A1 |
ANDERSON; Nicholas ; et
al. |
October 14, 2021 |
CAPPING AND CLEANSING DEVICES FOR NEEDLEFREE VASCULAR ACCESS
CONNECTORS
Abstract
Capping and cleansing devices for capping and cleansing
needlefree connectors, particularly luer access devices such as
needlefree vascular access connectors, and methods for using said
devices, are described. The devices of the invention each include
interconnected inner and outer housings that a user can transition
between a locked or engaged position to allow the inner and outer
housings to rotate in unison and an unlocked or disengaged position
that allows the outer housing to rotate independently of the inner
housing, and a compressible cleansing matrix secured in the device
(preferably in a well in the outer housing).
Inventors: |
ANDERSON; Nicholas;
(Brooklyn, NY) ; GRANT; John; (Solana Beach,
CA) ; CHAMBERS; Daniel M.; (Solana Beach, CA)
; ARIELY; Adam; (Encinitas, CA) ; MATSUURA; David
G.; (Del Mar, CA) ; SIMPSON; Philip J.;
(Escondido, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
CleanSite Medical, Inc. |
Solana Beach |
CA |
US |
|
|
Assignee: |
CleanSite Medical, Inc.
Solana Beach
CA
|
Family ID: |
1000005669266 |
Appl. No.: |
17/342630 |
Filed: |
June 9, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16795565 |
Feb 19, 2020 |
11065431 |
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17342630 |
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16059029 |
Aug 8, 2018 |
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16795565 |
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62807239 |
Feb 19, 2019 |
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62542770 |
Aug 8, 2017 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 39/20 20130101;
A61M 2205/0205 20130101; A61M 39/162 20130101; A61M 39/18
20130101 |
International
Class: |
A61M 39/16 20060101
A61M039/16; A61M 39/20 20060101 A61M039/20; A61M 39/18 20060101
A61M039/18 |
Claims
1. A capping and cleansing device for a threaded valve portion of a
needlefree vascular access connector, comprising: (a) an inner
housing rotatably disposed in an outer housing, wherein the inner
housing comprises a sidewall that bounds a central bore into which
the threaded valve portion of the needlefree vascular access
connector can be threaded opposite a compressible cleansing matrix
attached to the outer housing that protrudes into the central bore
and can contact a surface of the threaded valve portion of the
needlefree vascular access connector when the capping and cleansing
device is threaded onto the threaded valve portion of the
needlefree vascular access connector; (b) the outer housing,
wherein the outer housing comprises a cavity in which the inner
housing is rotatably disposed, wherein the outer housing is
configured to engage and disengage from the inner housing so as to
allow the outer housing to retain the inner housing and (i) be
rotated independently of the inner housing at least 360 degrees in
both a clockwise direction and a counter-clockwise direction by a
user when the outer housing is not engaging the inner housing and
(ii) be rotated in unison with the inner housing by the user when
the outer housing and the inner housing are engaged; (c) the
compressible cleansing matrix attached to the outer housing and
protruding into the cavity of the outer housing and into the
central bore of the inner housing, wherein the compressible
cleansing matrix rotates with the outer housing; and (d) a liquid
disinfectant disposed in the compressible cleansing matrix.
2. The capping and cleansing device according to claim 1 that
further comprises a removable lid to seal the cavity of the outer
housing from an external environment.
3. The capping and cleansing device according to claim 2 that has
been sterilized.
4. The capping and cleansing device according to claim 1, wherein
the liquid disinfectant comprises isopropyl alcohol.
5. The capping and cleansing device according to claim 4, wherein
the liquid disinfectant comprises a solution of about 70% isopropyl
alcohol and water.
6. The capping and cleansing device according to claim 5, wherein
the liquid disinfectant further comprises chlorhexidine, optionally
chlorhexidine gluconate.
7. The capping and cleansing device according to claim 1 that
further comprises a seal between the inner housing and the outer
housing.
8. The capping and cleansing device according to claim 7, wherein
the seal is formed between a seal element disposed on an interior
surface of the outer housing and a sealing surface on an upper
exterior portion of the sidewall of the inner housing.
9. The capping and cleansing device according to claim 1, wherein
the outer housing further comprises an outer surface having a
plurality of vertical ridges.
10. The capping and cleansing device according to claim 1, wherein
the compressible cleansing matrix is configured to contact at least
a valve surface of the threaded valve portion of the needlefree
vascular access connector when the capping and cleansing device is
threaded onto the threaded valve portion of the needlefree vascular
access connector.
11. The capping and cleansing device according to claim 10, wherein
the compressible cleansing matrix is configured to also contact an
additional surface of the threaded valve portion of the needlefree
vascular access connector when the capping and cleansing device is
threaded onto the threaded valve portion of the needlefree vascular
access connector.
12. The capping and cleansing device according to claim 1, wherein
the outer housing comprises an outer wall connected to a top wall
to form the cavity, which cavity is accessible through an opening
opposite the top wall, wherein the outer wall of the outer housing
is resilient and configured to deform upon application by a user of
manual force sufficient to cause a portion of an inner surface of
the outer wall to engage an outer surface of the inner housing
during application of the manual force by the user in order to
rotate the inner housing and outer housing in unison in order to
secure or remove the capping and cleansing device to or from the
threaded valve portion of a needlefree vascular access
connector.
13. The capping and cleansing device according to claim 1, wherein
the outer housing comprises at least one inner housing retaining
structure disposed on an inner surface of the outer wall of the
outer housing that is configured to (i) engage a complementary
retention element on an outer surface of the inner housing and (ii)
allow the inner housing to retained in the cavity such that the
outer housing can be rotated in relation to the inner housing at
least 360 degrees in both a clockwise direction and a
counter-clockwise direction when the outer housing is disengaged
from the inner housing while the capping and cleansing device is
secured to the threaded valve portion of a needlefree vascular
access connector.
14. The capping and cleansing device according to claim 1, wherein
an inner surface of the top wall of the outer housing defines a
concentric matrix well adapted to receive and securely retain the
compressible cleansing matrix and to translate rotational motion
from the outer housing to the compressible cleansing matrix when
the capping and cleansing device is threaded on to the threaded
valve portion of a needlefree vascular access connector.
15. An assembly that comprises a single piece of lidding on to
which a plurality of capping and cleansing devices according to
claim 1 are sealed prior to or after sterilization.
16. An assembly that comprises a capping and cleansing device
according to claim 1 threaded on to a threaded valve portion of a
needlefree vascular access connector.
17. A method of cleansing a needlefree vascular access connector,
comprising: (a) securing a capping and cleansing device according
to claim 1 to a threaded valve portion of the needlefree vascular
access connector; and (b) without engaging the outer housing and
inner housing, rotating the outer housing in relation to the inner
housing, thereby cleansing one or more surfaces of the threaded
valve portion of the needlefree vascular access connector.
18. The method according to claim 17 that further comprises
removing the capping and cleansing device from the threaded valve
portion of the needlefree vascular access connector immediately
after cleansing the one or more surfaces of the threaded valve
portion of the needlefree vascular access connector.
19. The method according to claim 17 that further comprises leaving
the capping and cleansing device connected to the threaded valve
portion of the needlefree vascular access connector.
20. The method according to claim 19 that further comprises leaving
the capping and cleansing device connected to the threaded valve
portion of the needlefree vascular access connector for up to 7
days.
Description
RELATED APPLICATIONS
[0001] This application claims the benefit of and priority to, and
is a continuation of, commonly owned, co-pending allowed U.S.
patent application Ser. No. 16/795,565, filed on 19 Feb. 2020,
which claims the benefit of and priority to (now-expired) U.S.
provisional patent application No. 62/807,239, filed on 19 Feb.
2019 and U.S. patent application Ser. No. 16/059,029, filed on 8
Aug. 2018 (to which U.S. Ser. No. 16/795,565 is a
continuation-in-part), which claims the benefit of and priority to
(now-expired) U.S. provisional patent application No. 62/542,770,
filed on 8 Aug. 2017. All of the aforementioned priority
applications are hereby incorporated by reference, each in its
entirety for any and all purposes.
TECHNICAL FIELD OF THE INVENTION
[0002] This invention is directed to cleansing devices for
cleansing and capping medical devices, particularly luer access
devices such as needlefree, valved connectors (NCs), and methods
for making and using such articles.
BACKGROUND OF THE INVENTION
1. Introduction
[0003] The following description includes information that may be
useful in understanding the present invention. It is not an
admission that any such information is prior art, or relevant, to
the presently claimed inventions, or that any publication
specifically or implicitly referenced is prior art.
2. Background
[0004] In the medical field, and in particular the area of infusion
of fluids or aspiration of fluids to or from a patient, there
remains a need to prevent the transmission of pathogens into or
onto a patient from a potentially contaminated surface of a medical
device such as a luer access device, for example, a needlefree,
valved connector (NC). Pathogens include microorganisms such as
bacteria, fungi, and viruses, the transmission of which 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 significant morbidity, mortality, and
an expense. Indeed, nosocomial infections are estimated to more
than double the mortality and morbidity risks of any admitted
patient, and likely result in about 100,000 deaths a year in the
United States alone. Common sites for the transmission of
contaminating microorganisms into a patient's bloodstream are found
on medical devices such as luer access devices, vials, needlefree
(or needle free) valves, and the injection ports of vessels,
tubing, and catheters. The incidence of such infections in patients
is increasing, and infection control practitioners (ICPs) often
cite improper cleansing of sites as a major source of such
infections.
[0005] As described above, patient exposure to pathogens and
infectious reagents (e.g., pathogenic bacteria, viruses, fungi,
etc.) in medical settings (e.g., hospitals, out-patient surgery
centers, home-care settings, etc.) is a matter of serious concern.
One route of exposure to such reagents is the opening made in skin
provided by the bore of needle, cannula, or other similar device
used to provide access to a patient's vasculature. It is known that
patients whose skin has been compromised in this way are at
increased risk for developing serious blood stream infections. In
the United States alone, approximately 300,000 blood stream
infections per year result from the installation and use of
peripheral intravenous catheters (PIVC), and more than 80,000 blood
stream infections are associated with the use central venous
catheters (CVC). All told, in the U.S. approximately 28,000
patients die annually from hospital-acquired infections that result
from PIVC and CVC use, and many times that number are made
seriously ill but survive. Costs associated with the care and
treatment of patients that develop infections due to PIVC and CVC
use is estimated to exceed $4 billion annually in the U.S.
alone.
[0006] In hospital settings today, occupational health and safety
regulations designed reduce the risk to health care workers from
needle stick and similar injuries have resulted in the deployment
of needlefree medical valves (also referred to herein as
"needlefree connectors" or "NCs") whenever possible. Currently,
more than 1 billion NCs are used annually in hospitals throughout
the U.S. Needlefree connectors are used primarily in conjunction
with PIVC and CVC devices and associated IV administration and
extension sets, which may contain from as few as one to as many as
3, 4, 5, or more NCs. FIG. 2A illustrates an example of a
representative NC in use today.
[0007] The widespread use of needlefree connectors in acute
medicine has contributed to a marked increase in the incidence of
hospital-acquired infections (HAIs), particularly blood stream
infections (BSIs). To reduce the risk of infection from a
needlefree connector contaminated with microorganisms, standard
practice today requires that a nurse or other healthcare worker
clean (or "scrub") the surface of NC by vigorously rubbing those of
its exterior surfaces in the fluid path with a sterile alcohol swab
or wipe immediately prior to making a fluid connection to the NC,
for example, by attaching a syringe to the NC's threaded valve
portion to deliver a medication via a PIVC already connected to the
patient. Given the magnitude of the mortality and morbidity
associated with HAIs, particularly with regard to central
line-associated blood stream infections (CLABSIs), and the large
number of blood stream infections that result from PIVC and CVC use
(so-called "peripheral line-associated blood stream infections
(PLABSIs) and central line-associated blood stream infections
(CLABSIs), respectively), a long-recognized yet significant unmet
need exists for articles or devices that can be used to reduce or
eliminate the risk of initiating an HAI merely by accessing a
patient's vasculature through a needlefree valve component of a
PIVC or CVC inserted into a blood vessel of a patient.
[0008] Traditionally, and as noted above, cleaning, cleansing, or
disinfecting a potentially contaminated NC surface involved a
protocol of alcohol swabbing prior to making the necessary
connections to the site. Alcohol swabs are typically small pads of
cotton gauze soaked in isopropyl alcohol (IPA), packed individually
in foil packages to prevent evaporation of the IPA from the swab
prior to use. Properly used, the package is opened at or near the
site to be swabbed. With gloved hands, the swab is removed by a
nurse or other healthcare provider and used to scrub the top and
side surfaces of the valve portion of the NC to be connected. After
use, the swab and foil package are discarded and the cleansed valve
portion of the NC is allowed to dry, usually 20-30 seconds,
immediately prior to making any connection. This "drying" period is
important because, as the IPA dries, it breaks open the cellular
walls of microorganisms, thereby killing them.
[0009] Unfortunately, because of increased duties and
responsibilities, shrinking nursing staffs, and inadequate
training, alcohol swabbing (or scrubbing) is often not performed or
is poorly executed. A poorly swabbed site can carry microorganisms
that, if allowed to enter a patient's body, can cause serious, and
potentially life-threatening, infection. In addition, supervisory
oversight is nearly impossible, because unless a supervisor
actually observes swabbing as it is performed, the supervisor
cannot know whether or not the scrubbing procedure was done
properly or performed at all. Indeed, reported compliance with such
"scrub the hub" protocols has been as low as 10%. Further, without
at least a sufficient microscopic examination for microbial residue
(e.g., biofilm), there may be no evidence of "scrubbing the hub"
being performed.
[0010] Thus, a significant need still exists for devices and
techniques cleanse sites on medical devices prior to their use with
or connection to patients, and which eliminate technique-related
and training issues and provide an unequivocal indicator that a
site is clean prior to accessing a patient's vascular system.
3. Definitions
[0011] Before describing the instant invention in detail, several
terms used in the context of the present invention will be defined.
In addition to these terms, others are defined elsewhere in the
specification, as necessary. Unless otherwise expressly defined
herein, terms of art used in this specification will have their
art-recognized meanings.
[0012] As used herein, the singular forms "a", "an", and "the"
include plural references unless the context clearly dictates
otherwise. [0013] As used herein, the term "about" refers to
approximately a +/-10% variation from the stated value. It is to be
understood that such a variation is always included in any given
value provided herein, whether or not it is specifically referred
to.
[0014] A "patentable" composition, process, machine, or article of
manufacture according to the invention means that the subject
matter at issue satisfies all statutory requirements for
patentability at the time the analysis is performed. For example,
with regard to novelty, non-obviousness, or the like, if later
investigation reveals that one or more claims encompass one or more
embodiments that would negate novelty, non-obviousness, etc., the
claim(s), being limited by definition to "patentable" embodiments,
specifically excludes the unpatentable embodiment(s). Also, the
claims appended hereto are to be interpreted both to provide the
broadest reasonable scope, as well as to preserve their validity.
Furthermore, if one or more of the statutory requirements for
patentability are amended or if the standards change for assessing
whether a particular statutory requirement for patentability is
satisfied from the time this application is filed or issues as a
patent to a time the validity of one or more of the appended claims
is questioned, the claims are to be interpreted in a way that (1)
preserves their validity and (2) provides the broadest reasonable
interpretation under the circumstances.
[0015] A "plurality" means more than one.
[0016] The term "species", when used in the context of describing a
particular compound or molecule species, refers to a population of
chemically indistinct molecules.
SUMMARY OF THE INVENTION
[0017] The object of the invention is to address these
long-standing but still unmet needs. This invention addresses these
needs by providing patentable, single-use cleansing (disinfecting)
and capping devices or articles that can be used to effectively and
efficiently cleanse/disinfect and cap, and preferably sterilize,
exposed surfaces of medical articles such as luer access devices,
particularly needlefree connectors, particularly the accessible
surface(s) of the threaded valve portions of needlefree connectors,
particularly those surfaces (valve surfaces, threads, etc.) that
may become contaminated with pathogens or other infectious reagents
and which form part of the fluid communication pathway between an
external fluid source (e.g., a medicine filled syringe with a male
luer fitting, an IV bag, etc.) and a patient's blood stream. In the
context of the invention, "cleanse" encompasses cleaning,
disinfecting, sanitizing, and/or sterilizing, whereas "capping"
refers to using a device, i.e., a "cap", to cover a surface, or set
of surfaces, of an NC so as to limit or prevent exposure of such
surface(s) to the environment (e.g., the air circulating in a
hospital's intensive care unit, the microbiome resident on a
patient's skin, clothing, bedding, unclean fingers, etc.) for a
period longer than necessary to cleanse the desired surface(s) of a
needlefree connector.
[0018] Thus, in one aspect, the invention provides capping and
disinfecting devices for medical devices such as luer access
devices, including needlefree, valved vascular access connectors
(NCs). In general, such devices include an inner housing configured
to allow the device to be screwed onto and unscrewed from the
threaded valve portion of an NC, an outer housing that retains the
inner housing but which a user can, when desired, rotate
independently of the inner housing to provide scrubbing or
disinfecting action, and a compressible cleansing matrix preferably
impregnated with a disinfectant, for example, a 70% IPA solution.
The device also preferably includes an easily removable seal to
maintain sterility and prevent loss of the disinfectant after the
device is assembled until such time as it is used in the field to
outer housing and cleanse an NC.
[0019] The devices of the invention include an inner housing. In
some preferred embodiments, the inner housing is comprised of a
sidewall that bounds a central, interior (preferably cylindrical)
bore that spans between oppositely disposed first and second (or
upper and lower, respectively) openings. In many of these
embodiments, the first (upper) opening is sized to allow the
compressible cleansing matrix resident at least in part in a matrix
well or otherwise attached to the inner surface of the outer
housing to protrude into and through the opening into the inner
housing's central bore so that the compressible cleansing matrix
can engage one or more exterior surfaces of a needlefree connector
when the capping and cleaning device is secured to the connector.
The second (lower) opening of the inner housing is sized to allow
the threaded valve portion of a needless connector to be capped
and/or cleansed to be inserted into capping and cleansing device of
the invention. The interior wall of the inner housing's central
bore includes one or more thread-engaging tabs (or threads),
preferably two (or more) oppositely disposed (or otherwise spaced)
thread-engaging tabs, preferably near the lower opening. The
thread-engaging tab(s) (or threads) is (are) configured to engage a
complementary threaded region on the exterior surface of, for
example, a needlefree connector such that the capping and cleansing
device can, via association of the thread tabs or threads on the
interior of the inner housing's central bore with complementary
threads on the threaded portion of a needlefree connector, be
securely threaded onto (or otherwise removably connected with) the
targeted threaded portion of a needlefree connector for capping
and, if desired, cleansing.
[0020] In some preferred embodiments, the outer surface of the
inner housing includes an outer housing-retaining region that
includes one or more structures, for example, a circumferential
flange (or spaced flange elements), that allow the inner housing to
be retained in the outer housing via association with one or more
complementary structures (e.g., a circumferential flange (or spaced
flange elements) or other suitable engaging elements) on the inner
surface of the sidewall of the outer housing. Preferably, such
configurations of complementary retaining elements also allow for
smooth, low friction movement (i.e., rotation) of the inner and
outer housings in relation to each other during certain operations,
for example, during a disinfection procedure of a needlefree
connector. In some of these embodiments, the retaining element(s)
of the inner housing can mechanically engage an adjacent region on
the inner surface of the sidewall of the outer housing, for
example, when a user squeezes or otherwise applies sufficient force
to the outer housing to deform it so as to allow engaging regions
on the inner surface of the outer housing to engage corresponding
engaging regions on the exterior surface of the inner housing so as
to allow the inner and outer housings to rotate in unison (as would
occur, for example, when a user attaches or removes a device from
an NC). In some of these embodiments, the retaining element(s) of
the inner housing can also serve as engaging elements with
complementary regions, features, or structures on the inner surface
of the sidewall of the outer housing adjacent or otherwise in close
proximity thereto. In other embodiments, the outer surface of the
inner housing further includes one or more outer housing engaging
elements or regions designed to associate with one or more inner
housing engaging elements or regions disposed on the interior or
inner surface of the outer housing. Examples of such elements
include, for example, a circumferential band of spaced teeth or
teeth-like elements protruding from the exterior surface of the
inner housing and positioned below the outer housing-retaining
region (e.g., a circumferential flange), which teeth (or other
suitable engaging structures) can be engaged by complementary
structures arrayed on the interior surface of the outer housing
when the housings are assembled into a functional subassembly.
[0021] In other preferred embodiments, the upper exterior surface
of the inner housing includes an outer housing-engaging region that
includes one or more structures that allow the inner housing to
mechanically engage complementary structures (e.g., pawls or other
suitable engaging elements) on the inner surface of the top of the
outer housing so that when the complementary engaging elements of
the outer housing and inner housing are brought into close
proximity the engaging elements of the outer housing and inner
housing engage, allowing the outer housing and inner housing to
rotate in unison. Certain preferred embodiments of outer
housing-engaging structures include spaced teeth (or other suitable
engaging elements) arrayed on the top or upper surface of the inner
housing's preferably cylindrical sidewall. As will be appreciated,
when such inner and outer housing engaging elements are unmated or
disengaged, a user can rotate or spin the outer housing in relation
to the inner housing, as is, for example, done during a cleansing
or disinfecting operation of the needlefree connector to which the
device of the invention is attached. Thus, when the capping and
cleansing device is secured to a needlefree connector, when such
engaging elements are not functionally associated (or mated or
otherwise engaged), a user can rotate the outer housing (and
compressible cleansing matrix) in relation to the inner housing and
connected needlefree connector. On the other hand, when the
complementary elements on the inner surface of the top of the outer
housing and the upper surface of the top of the inner housing are
engaged (in whole or even partially), such as when a user applies
downward pressure to the device to place it on or remove it from a
needlefree connector, the inner and outer housings rotate together,
allowing, for example, the capping and cleansing device to be
attached to or removed from the NC.
[0022] In some preferred embodiments, the inner housing also
includes an NC sealing member configured to provide a fluid tight
seal between the capping and cleansing device of the invention and
a needlefree connector connected thereto. In some embodiments the
NC sealing member is an O-ring (or comparable seal) preferably
disposed in a channel formed in the inner surface of the wall of
the inner housing proximate to the second (lower) opening,
typically below the thread-engaging tab(s) (or threads).
[0023] The devices of the invention also include an outer housing
adapted or configured to retain the inner housing therein such
that, when the device is attached to a needlefree connector, under
certain conditions the outer housing can rotate (preferably about
its central axis) in relation to the inner housing. Any suitable
configuration of complementary mechanical or structural features or
elements on facing or opposing surfaces can be used to provide
retention of the inner housing inside the outer housing's main
cavity and to allow for engagement and disengagement of the outer
housing from the inner housing in order to allow the outer housing
to be rotated in relation to the inner housing when the device is
attached to a needlefree connector and a user desires to cleanse
the corresponding surface(s) of the NC using the capping and
cleansing device of the invention.
[0024] In some embodiments, when the device of the invention is
attached to a needlefree connector, the inner and outer housings
adopt a disengaged, neutral, or rotating configuration relative to
each other such that a user can rotate the outer housing in
relation to the inner housing to perform a cleansing operation on
the valve portion of the NC to which the device is attached. Such a
disengaged, neutral, or rotating configuration can be achieved by
any suitable approach, including by providing complementary
engaging elements or structures on adjacent surfaces of the inner
and outer housings that under certain conditions, for example, when
the outer housing is pulled up, pushed down, or squeezed by a user
in relation to the inner housing, engage each other; otherwise the
engaging elements remain disengaged, which allows rotation of the
outer housing in relation to the inner housing when the device is
secured to an NC. Features that allow transitioning between engaged
and disengaged positions include springs or biasing or resilient
elements or materials. In other embodiments, when the device is
attached to a needlefree connector, the inner and outer housings
adopt an engaged configuration relative to each other such that
they rotate in unison unless a user applies sufficient force to the
outer housing to cause the engaging elements to disengage and thus
allow the outer housing to be rotated independently of the inner
housing.
[0025] The outer housing includes a cylindrical cavity designed to
receive and retain the inner housing using one or more features or
elements that allow the outer housing to be rotated in relation to
the inner housing if and when desired. The cavity is formed by a
curved outer sidewall that in some embodiments is joined to a top
portion of the housing about its periphery and which also
preferably has a concentric central matrix well or matrix
attachment region to or with which the compressible cleansing
matrix is attached or otherwise associated, although in some
embodiments some degree of eccentricity between the matrix well and
central rotational axis of the outer housing may be desired. In
some embodiments, the outer housing is formed by a sidewall that is
tapered and/or has one or more steps.
[0026] In some preferred embodiments, the inner surface of the top
of the outer housing includes one or more inner housing engaging
elements or structures (e.g., teeth) designed to releasably engage
complementary structures in the outer housing-engaging region on
the top of the inner housing. Engagement of the outer housing's
inner housing engaging structure(s) with those in the outer
housing-engaging region of the inner housing allow a user to rotate
the outer housing and inner housing in unison, for example, as a
capping and cleansing device's inner housing is screwed onto the
threaded portion of a needlefree connector to be cleansed and/or
capped. Once the device is releasably secured to a needlefree
connector via the inner housing, the outer housing's inner housing
engaging elements or structure(s) can be (or are) disengaged from
the outer housing-engaging elements of the inner housing, for
example, by the biasing action or resilience of a the compressible
cleansing matrix, thereby allowing a user to rotate the outer
housing about its central axis in relation to the inner housing. A
representative example of such engaging structures is shown in
published US patent application publication no. 2018/0304067,
although features such as an inner housing having an opening in its
top to allow a compressible cleansing matrix attached to the inner
surface of the top of the outer housing to extend into the bore of
the inner housing so that it can contact surfaces of a needlefree
connector upon connection of the former to the latter are also
envisioned.
[0027] In some of these embodiments, the outer housing may include
one or more vents to allow fluid and/or air from inside the device
to escape as the capping and cleansing device is secured to a
needlefree connector, while in other embodiments, no vent(s) is
(are) provided. In embodiments with one or more vents, a membrane,
filter, or other permeable or semi-permeable barrier may be
employed to allow a unidirectional or bidirectional flow of air,
gas, or vapor through the vent(s) but prevent the movement of
microorganisms (e.g., bacteria, fungi, viruses, etc.) into the
capping and cleansing device of the invention.
[0028] In certain preferred embodiments, the outer surface of the
outer housing of a capping and cleansing device according to the
invention includes one or more grip-enhancing structures (e.g., a
plurality of vertical ridges) or coatings. Such grip-enhancing
structures or coatings facilitate a user's grasp of the housing of
a capping and cleansing device between her/his fingers, which can
be helpful not only during insertion and removal of a needlefree
connector from the capping cleansing device, but also during the
cleansing process, where the user rotates the outer housing in
relation to the inner housing in order to scrub and thereby clean
or cleanse the surface(s) of the inserted needlefree connector with
the compressible cleansing matrix of the device.
[0029] In some preferred embodiments, the devices of the invention
include one or more elements or features arrayed on facing surfaces
of the inner and outer housings that allow a user to sense that the
outer housing is rotating in relation to the inner housing in order
to provide cleansing action on the valve surface of the NC to which
the device is attached. Such sensory feedback can include one or
more of auditory, tactile, and/or visual stimuli generated from the
device by rotation of the outer housing in relation to the inner
housing.
[0030] In the devices of the invention, the inner and outer
housings are manufactured separately by any suitable process, for
example, 3D-printing, injection molding, etc., and then assembled
into a two-part subassembly in which the inner housing is retained
within the main cavity of the outer housing by one or more
complementary retaining elements, features, or structures on each
housing. The inner and outer housings also include complementary
mechanical or structural engaging elements, features, or structures
on one or more interfacing surfaces that can be engaged and
disengaged so as to allow the inner and outer housings to rotate
together or to allow the outer housing to rotate independently of
the inner housing. In this way, the inner and outer housings can be
associated such that they can rotate in unison, allowing a user to
thread (or screw) the device onto or remove (unscrew) it from the
threaded valve portion of an NC if and when desired, while also
making it possible for a user to rotate the outer housing in
relation to the inner housing, thereby allowing the compressible
cleansing matrix to effectively scrub or cleanse the region(s) of a
threaded valve portion of an NC to which it is attached. In certain
preferred embodiments, the inner and outer housings further include
complementary mechanical or structural housing sealing elements,
features, or structures on one or more interfacing surfaces that
allow formation of seal between adjacent surfaces of the inner and
outer housings, which seal is preferably substantially fluid tight
but does not substantially hinder or inhibit rotation of the outer
housing in relation to the inner housing during performance of a
cleansing procedure or process by a user. In some embodiments, the
inner housing may also include a seal that interacts with the
needlefree connector to form an additional or alternate seal.
[0031] A capping and cleansing device of the invention also
includes a compressible cleansing matrix disposed therein. In most
embodiments, the compressible cleansing matrix is disposed in a
matrix well or the like in the interior of the outer housing,
although any suitable retaining configuration can be employed that
allows the compressible cleansing matrix to rotate in conjunction
with rotation of the outer housing so as to provide the capability
of using the compressible cleansing matrix to scrub or otherwise
clean, cleanse, or disinfect the surface(s) of the valve region of
a needlefree connector. As will be appreciated, the compressible
cleansing matrix is positioned to contact one or more exterior
surface(s) of an NC connected to the capping and cleansing device.
The compressible cleansing matrix, for example, an open-cell or
felted foam, is preferably retained in the matrix well by one or
more matrix retaining elements, which element(s) assist in
retention of the compressible cleansing matrix in the matrix well
in addition to transmission of rotational forces from the outer
housing to the compressible cleansing matrix as occurs during a
procedure to disinfect or cleanse a needlefree connector. As will
be appreciated, during such rotation (of the outer housing and
compressible cleansing matrix), the compressible cleansing matrix
also rotates in relation to the inner housing when the outer
housing is rotated during a procedure to disinfect or cleanse a
needlefree connector. The compressible cleansing matrix attached to
or otherwise associated with the outer housing can be axially
compressed (i.e., compressed along the central axis of the outer
housing's matrix well) upon insertion of a needlefree connector
into such a capping and cleansing device.
[0032] Because the needlefree connector surface(s) to be cleansed
may be contaminated with microorganisms that form a biofilm (i.e.,
a matrix of microorganisms and extracellular material attached to a
surface, which enables the microorganisms, typically bacteria
and/or fungi, to adhere to a surface and carry out certain
biochemical processes), the compressible cleansing matrix also
preferably has sufficient mechanical integrity when compressed and
rotated to allow it to disrupt any biofilm that may be present on
the surface of the needlefree connector, as can occur by rotating,
twisting, or otherwise moving the then-compressed cleansing matrix
in relation to the needlefree connector, for example, by rotating
the outer housing (to which the compressible cleansing matrix is
attached) in relation to the inner housing of the capping and
cleansing device and the needlefree connector to which inner
housing is releasably attached. The resulting friction between the
compressed cleansing matrix and surface of the needlefree connector
disrupts the biofilm, thereby cleansing, and preferably
sterilizing, the needlefree connector. Leaving the capping and
cleansing device secured to (i.e., capping) the needlefree
connector after such a cleansing operation will limit, and
preferably preclude, biofilm regrowth and/or the microbial
recolonization of cleansed surfaces (which remain in contact with
the compressible cleansing matrix).
[0033] In preferred embodiments, the compressible cleansing matrix
includes one or more cleansing reagent species dispersed therein,
preferably at the time the device is manufactured, although in some
embodiments, the cleansing reagent may be dispersed into the matrix
just prior to the matrix coming into contact with a needlefree
connector. In embodiments of the latter sort, the cleansing reagent
is preferably housed in the housing of the capping and cleansing
device in a reservoir configured to be ruptured just prior to
performance of a cleansing operation. In some embodiments, the
capping and cleansing device of the invention will include a valve
or opening to allow liquid in the cleansing reagent to
evaporate.
[0034] In some preferred embodiments, the compressible cleansing
matrix includes two or more components. In some of such
embodiments, one component of the matrix is attached to the inner
surface of the outer housing and another component is secured to
the inner surface of the wall forming the inner housing, preferably
between protruding threaded regions adapted to engage complementary
threads on a needlefree connector. If present, the component of the
compressible cleansing matrix secured to the inner surface of the
inner housing wall is preferably configured to radially compress
upon association with a needlefree connector to be capped and
cleansed.
[0035] In preferred embodiments, the capping and cleansing devices
of the invention include a removable lid or seal attached to the
outer housing to seal the device, thus separating the interior
spaces and structures of the inner and outer housings from the
external environment. Such a lid or seal prevents exposure of the
device's interior, including the inner housing and compressible
cleansing matrix, to the environment until the removable
(preferably, peelable) lid or seal is removed, typically by a
healthcare worker just prior to her/his use of the capping and
cleansing device to clean, cleanse, or disinfect a needlefree
connector to which a fluid connection is to be made. In preferred
embodiments, such cleansing substantially disrupts any microbial
contamination, for example, microbial biofilm or other microbial
contamination that may exist on surfaces contacted by the
compressible cleansing matrix. If desired, the capping and
cleansing device can be left in place (typically after cleansing
the needlefree connector attached thereto) in order to cap the
needlefree connector until it is further accessed, thereby
minimizing exposure of capped exterior surfaces of the NC to
potential pathogen contamination (and biofilm formation) from the
surrounding environment. Lids or seals are typically installed
during manufacture of a capping and cleansing device of the
invention. In those embodiments where the capping and cleansing
devices are sterilized during manufacture (e.g., by irradiation,
exposure to ethylene oxide, etc.), lids or seals are preferably
applied prior to packaging and sterilization.
[0036] In some preferred embodiments, the devices of the invention
are sealed individually, while in other embodiments, 2-20 or more
devices are sealed onto a single piece of lidding or sealing stock,
after which they may be separated into individual sealed products
or maintained in strip form, as a strip format having multiple
devices all sealed to a single strip is a convenient format for use
in healthcare environments, where such strips can be hung, for
example, from an IV pole at a patient's bedside. After sealing and
packaging, the devices of the invention are sterilized using any
suitable sterilization method (e.g., gamma or e-beam irradiation,
treatment with ethylene oxide, etc.) compatible with the materials
used to manufacture the particular device(s) of the invention.
[0037] Other aspects of the invention concern methods of cleansing
and/or capping needlefree connectors using a capping and cleansing
device according to the invention. Such methods typically involve
disengaging the engaging elements of the outer housing and inner
housing after it has been connected to a needlefree connector, thus
allowing a user to rotate or spin the outer housing in relation to
the inner housing and needlefree connector to which the device of
the invention is secured. Such disengagement does not impair
contact between the device's compressible cleansing matrix and the
associated surface(s) of the needlefree connector. Spinning or
rotation of the outer housing in relation to the inner housing, and
the associated surface(s) of the needlefree connector, allow those
surfaces to be scrubbed, thereby cleansing them. Preferably, such
cleansing methods provide for the disruption of any biofilm present
on the surface(s) of the needlefree connector associated the
capping and cleansing device. And in those embodiments where the
compressible cleansing matrix contains one or more antimicrobial
reagents, microbes and pathogens present in such biofilm and/or on
such surface(s) are preferably destroyed or rendered nonviable.
[0038] Features and advantages of the invention will be apparent
from the following detailed description, and appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0039] These and other aspects will now be described in detail with
reference to the following drawings. Unless otherwise indicated, it
is understood that the drawings are not to scale, as they are
intended merely to facilitate understanding of the invention as
opposed to specific dimensions, etc. In the drawings, like numbers
in two or more drawings represent like elements.
[0040] FIG. 1A-FIG. 1H shows several drawings ((a)-(h)) of a
representative capping and cleansing device of the invention, its
constituent parts (views (b)-(h)), and the device associated with a
needlefree connector (view (a)).
[0041] FIG. 2A-FIG. 2D shows an exploded view (a) of a
representative capping and cleansing device of the invention and a
needlefree connector and several cross-sectional views ((b)-(d)) of
a sealed representative capping and cleansing device of the
invention (view (b)) and such a capping and cleansing device
capping a needlefree connector (views (c) and (d)).
[0042] FIG. 3A-FIG. 3F shows six different views of a
representative capping and cleansing device of the invention. Views
(a)-(c) show the device in a static position, where the cap and
resilient inner body are engaged such that the cap, and hence the
compressible cleansing matrix associated therewith, cannot rotate
in relation to the device's resilient inner body. Views (d)-(f)
show the same representative device with the cap and resilient
inner body in movable relation such that the cap (and the
compressible cleansing matrix associated therewith) can be rotated
in relation to the device's resilient inner body.
[0043] FIG. 4 shows views of the cap portion of a representative
capping and cleansing device of the invention. View (a) shows a top
view of the cap portion. View (b) shows a side view of the cap
portion. View (c) shows a bottom view of the cap portion. View (d)
shows a cross-sectional view of the cap portion. Representative
measurements of this particular embodiment are shown on views (b)
and (d).
[0044] FIG. 5A-FIG. 5H shows seven different views ((a)-(h)) of the
resilient inner body portion of a representative capping and
cleansing device of the invention. Representative measurements of
this particular embodiment are shown on several of the views.
[0045] FIG. 6A-FIG. 6E shows five different views ((a)-(e)), three
of which show a compressible cleansing matrix portion of a
representative capping and cleansing device of the invention. Views
(a)-(c) show top, side, and bottom views of this particular
compressible cleansing matrix. Views (d) and (e) show bottom and
side views of a seal portion of a representative capping and
cleansing device of the invention.
[0046] FIG. 7A-FIG. 7E shows five different views of another
representative capping and cleansing device of the invention. FIG.
7A shows an exploded perspective view of the device (outer housing,
compressible cleansing matrix, and inner housing) and an NC to
which the device is to be connected (see FIGS. 7B, 7E). FIG. 7B
shows a perspective view of the assembled device depicted in FIG.
7A secured to the threaded region of the valve portion of the NC
depicted in FIG. 7A. FIG. 7C shows an exploded cross-section view
of the components depicted in FIG. 7A, while in FIG. 7D, the cross
section view shows the components of the device of the invention
(outer housing, compressible cleansing matrix, and inner housing)
assembled into a functional capping and cleansing device ready for
attachment to the threaded region of the valve portion of the NC
depicted in FIG. 7A. FIG. 7E is a cross section showing the capping
and cleansing device of the invention screwed onto the NC, which
results compression of the compressible matrix against the NC's
valve surface.
[0047] FIG. 8A-FIG. 8E shows five different views of another
representative capping and cleansing device of the invention. FIG.
8A shows an exploded perspective view of the device (outer housing,
compressible cleansing matrix, and inner housing) and an NC to
which the device is to be connected (see FIGS. 8B, 8E). FIG. 8B
shows a perspective view of the assembled device depicted in FIG.
8A secured to the threaded region of the valve portion of the NC
depicted in FIG. 8A. FIG. 8C shows an exploded cross-section view
of the components depicted in FIG. 8A, while in FIG. 8D, the cross
section view shows the components of the device of the invention
(outer housing, compressible cleansing matrix, and inner housing)
assembled into a functional capping and cleansing device ready for
attachment to the threaded region of the valve portion of the NC
depicted in FIG. 8A. FIG. 8E is a cross section showing the capping
and cleansing device of the invention screwed onto the NC, which
results compression of the compressible matrix against the NC's
valve surface.
[0048] FIG. 9A-FIG. 9E shows five different views of another
representative capping and cleansing device of the invention, with
FIG. 9A showing a perspective view of the device secured to the
threaded region of the valve portion of an NC. FIGS. 9B and 9C each
show an exploded cross-section view of the device/NC assembly shown
in FIG. 9A, the difference being that the view depicted in FIG. 9C
is slightly rotated about the central axis of the device/NC
assembly as compared to the view depicted in FIG. 9B. FIG. 9D shows
an exploded perspective view of the device (outer housing,
compressible cleansing matrix, and inner housing) depicted in FIGS.
9A-9C. FIG. 9E shows a side cross-section and a bottom view of the
device depicted in FIGS. 9A-9D.
[0049] FIG. 10A-FIG. 10C shows three different cut-away views of
another representative capping and cleansing device of the
invention. FIGS. 10B and 10C show the device secured to the
threaded region of the valve portion of an NC, while FIG. 10A shows
the device disconnected from the NC. FIG. 10B shows the outer
housing of the device in a neutral position (the engaging elements
of the inner and outer housings are not engaged), from which a user
could rotate the outer housing (and compressible cleansing matrix)
in relation to the inner housing and NC, to which the inner housing
is secured. As will be appreciated, the compressible matrix can
serve as a spring that, in the absence of a sufficient
counteracting downward force, pushes the outer housing up in
relation to the inner housing, allowing a user to rotate the outer
housing (and compressible cleansing matrix) in relation to the
inner housing and NC is and when desired. Absent such rotation,
while connected to the NC the capping and cleansing device of the
invention serves as a cap to protect the threaded valve region of
the NC from environmental contamination, including microbial
contamination. FIG. 10C depicts the device when the engaging
elements of the inner and outer housings are engaged, allowing the
device to be screwed onto or off of the NC.
[0050] 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.
DETAILED DESCRIPTION
[0051] In the following detailed description, reference is made to
the accompanying figures (FIGS. 1A-10C), which form a part hereof.
In the figures, similar symbols typically identify similar
components, unless context dictates otherwise. The illustrative
embodiments described in the detailed description, figures, and
claims are not meant to be limiting. Other embodiments may be
utilized, and other changes may be made, without departing from the
spirit or scope of the subject matter presented here.
[0052] This invention concerns patentable single-use capping and
cleansing devices that can be used to effectively and efficiently
clean, disinfect, and preferably sterilize, exposed surfaces of
needlefree connectors, particularly those of luer access devices
such as needlefree medical valves that at times become part of a
fluid communication pathway for introduction of fluids (e.g., IV
fluids, blood, plasma, medicines, etc.) into a patient, as these
surfaces are at risk for contamination with pathogens and
infectious reagents such as bacteria, fungi, and viruses.
"Single-use" (or "single purpose") refers to an article or device
suitable for one use or purpose only, as distinguished from "dual"
or "multiple" use or purpose devices. Thus, in the context of the
invention, a "single-use" capping and cleansing device is one that
is useful for cleansing, for example, a needlefree medical valve.
After the cleansing operation, the device may, if desired, be left
in place on the needlefree connector until a subsequent fluid
connection is made in order to prevent recontamination of the
connector's cleansed surface(s), as would occur if the capping and
cleansing device of the invention was removed immediately following
"scrubbing" of the connector without a fluid connection then being
made. After removal, the device of the invention is preferably
discarded. Prior to removal, however, the capping and cleansing
device can again be used to cleanse the capped surface(s) of the
needlefree connector.
[0053] In general, a capping and cleansing device of the invention
include an inner housing configured to allow the device to be
screwed onto and unscrewed from the threaded valve portion of an
NC, an outer housing that retains the inner housing but which a
user can, when desired, rotate independently of the inner housing
to provide scrubbing or disinfecting action, and a compressible
cleansing matrix preferably impregnated with a disinfectant, for
example, a 70% IPA solution. The device also preferably includes an
easily removable seal to maintain sterility and prevent loss of the
disinfectant after the device is assembled until such time as it is
used in the field to outer housing and cleanse an NC.
[0054] In general, such devices include an inner housing configured
to allow the device to be screwed onto and unscrewed from the
threaded valve portion of an NC, an outer housing that retains the
inner housing but which a user can, when desired, rotate
independently of the inner housing to provide scrubbing or
disinfecting action, and a compressible cleansing matrix preferably
impregnated with a disinfectant, for example, a 70% IPA solution.
The device also preferably includes an easily removable seal to
maintain sterility and prevent loss of the disinfectant after the
device is assembled until such time as it is used in the field to
outer housing and cleanse an NC.
[0055] The devices of the invention include an inner housing. In
some preferred embodiments, the inner housing is comprised of a
sidewall that bounds a central, interior (preferably cylindrical)
bore that spans between oppositely disposed first and second (or
upper and lower, respectively) openings. In many of these
embodiments, the first (upper) opening is sized to allow the
compressible cleansing matrix resident at least in part in a matrix
well or otherwise attached to the inner surface of the outer
housing to protrude into and through the opening into the inner
housing's central bore so that the compressible cleansing matrix
can engage one or more exterior surfaces of a needlefree connector
when the capping and cleaning device is secured to the connector.
The second (lower) opening of the inner housing is sized to allow
the threaded valve portion of a needless connector to be capped
and/or cleansed to be inserted into capping and cleansing device of
the invention. The interior wall of the inner housing's central
bore includes one or more thread-engaging tabs (or threads),
preferably two (or more) oppositely disposed (or otherwise spaced)
thread-engaging tabs, preferably near the lower opening. The
thread-engaging tab(s) (or threads) is (are) configured to engage a
complementary threaded region on the exterior surface of, for
example, a needlefree connector such that the capping and cleansing
device can, via association of the thread tabs or threads on the
interior of the inner housing's central bore with complementary
threads on the threaded portion of a needlefree connector, be
securely threaded onto (or otherwise removably connected with) the
targeted threaded portion of a needlefree connector for capping
and, if desired, cleansing.
[0056] In some preferred embodiments, the outer surface of the
inner housing includes an outer housing-retaining region that
includes one or more structures, for example, a circumferential
flange (or spaced flange elements), that allow the inner housing to
be retained in the outer housing via association with one or more
complementary structures (e.g., a circumferential flange (or spaced
flange elements) or other suitable engaging elements) on the inner
surface of the sidewall of the outer housing. Preferably, such
configurations of complementary retaining elements also allow for
smooth, low friction movement (i.e., rotation) of the inner and
outer housings in relation to each other during certain operations,
for example, during a disinfection procedure of a needlefree
connector. In some of these embodiments, the retaining element(s)
of the inner housing can mechanically engage an adjacent region on
the inner surface of the sidewall of the outer housing, for
example, when a user squeezes or otherwise applies sufficient force
to the outer housing to deform it so as to allow engaging regions
on the inner surface of the outer housing to engage corresponding
engaging regions on the exterior surface of the inner housing so as
to allow the inner and outer housings to rotate in unison (as would
occur, for example, when a user attaches or removes a device from
an NC). In some of these embodiments, the retaining element(s) of
the inner housing can also serve as engaging elements with
complementary regions, features, or structures on the inner surface
of the sidewall of the outer housing adjacent or otherwise in close
proximity thereto. In other embodiments, the outer surface of the
inner housing further includes one or more outer housing engaging
elements or regions designed to associate with one or more inner
housing engaging elements or regions disposed on the interior or
inner surface of the outer housing. Examples of such elements
include, for example, a circumferential band of spaced teeth or
teeth-like elements protruding from the exterior surface of the
inner housing and positioned below the outer housing-retaining
region (e.g., a circumferential flange), which teeth (or other
suitable engaging structures) can be engaged by complementary
structures arrayed on the interior surface of the outer housing
when the housings are assembled into a functional subassembly.
[0057] In other preferred embodiments, the upper exterior surface
of the inner housing includes an outer housing-engaging region that
includes one or more structures that allow the inner housing to
mechanically engage complementary structures (e.g., pawls or other
suitable engaging elements) on the inner surface of the top of the
outer housing so that when the complementary engaging elements of
the outer housing and inner housing are brought into close
proximity the engaging elements of the outer housing and inner
housing engage, allowing the outer housing and inner housing to
rotate in unison. Certain preferred embodiments of outer
housing-engaging structures include spaced teeth (or other suitable
engaging elements) arrayed on the top or upper surface of the inner
housing's preferably cylindrical sidewall. As will be appreciated,
when such inner and outer housing engaging elements are unmated or
disengaged, a user can rotate or spin the outer housing in relation
to the inner housing, as is, for example, done during a cleansing
or disinfecting operation of the needlefree connector to which the
device of the invention is attached. Thus, when the capping and
cleansing device is secured to a needlefree connector, when such
engaging elements are not functionally associated (or mated or
otherwise engaged), a user can rotate the outer housing (and
compressible cleansing matrix) in relation to the inner housing and
connected needlefree connector. On the other hand, when the
complementary elements on the inner surface of the top of the outer
housing and the upper surface of the top of the inner housing are
engaged (in whole or even partially), such as when a user applies
downward pressure to the device to place it on or remove it from a
needlefree connector, the inner and outer housings rotate together,
allowing, for example, the capping and cleansing device to be
attached to or removed from the NC.
[0058] In some preferred embodiments, the inner housing also
includes an NC sealing member configured to provide a fluid tight
seal between the capping and cleansing device of the invention and
a needlefree connector connected thereto. In some embodiments the
NC sealing member is an O-ring (or comparable seal) preferably
disposed in a channel formed in the inner surface of the wall of
the inner housing proximate to the second (lower) opening,
typically below the thread-engaging tab(s) (or threads).
[0059] The devices of the invention also include an outer housing
adapted or configured to retain the inner housing therein such
that, when the device is attached to a needlefree connector, under
certain conditions the outer housing can rotate (preferably about
its central axis) in relation to the inner housing. Any suitable
configuration of complementary mechanical or structural features or
elements on facing or opposing surfaces can be used to provide
retention of the inner housing inside the outer housing's main
cavity and to allow for engagement and disengagement of the outer
housing from the inner housing in order to allow the outer housing
to be rotated in relation to the inner housing when the device is
attached to a needlefree connector and a user desires to cleanse
the corresponding surface(s) of the NC using the capping and
cleansing device of the invention.
[0060] In some embodiments, when the device of the invention is
attached to a needlefree connector, the inner and outer housings
adopt a disengaged, neutral, or rotating configuration relative to
each other such that a user can rotate the outer housing in
relation to the inner housing to perform a cleansing operation on
the valve portion of the NC to which the device is attached. Such a
disengaged, neutral, or rotating configuration can be achieved by
any suitable approach, including by providing complementary
engaging elements or structures on adjacent surfaces of the inner
and outer housings that under certain conditions, for example, when
the outer housing is pulled up, pushed down, or squeezed by a user
in relation to the inner housing, engage each other; otherwise the
engaging elements remain disengaged, which allows rotation of the
outer housing in relation to the inner housing when the device is
secured to an NC. Features that allow transitioning between engaged
and disengaged positions include springs or biasing or resilient
elements or materials. In other embodiments, when the device is
attached to a needlefree connector, the inner and outer housings
adopt an engaged configuration relative to each other such that
they rotate in unison unless a user applies sufficient force to the
outer housing to cause the engaging elements to disengage and thus
allow the outer housing to be rotated independently of the inner
housing.
[0061] The outer housing includes a cylindrical cavity designed to
receive and retain the inner housing using one or more features or
elements that allow the outer housing to be rotated in relation to
the inner housing if and when desired. The cavity is formed by a
curved outer sidewall that in some embodiments is joined to a top
portion of the housing about its periphery and which also
preferably has a concentric central matrix well or matrix
attachment region to or with which the compressible cleansing
matrix is attached or otherwise associated, although in some
embodiments some degree of eccentricity between the matrix well and
central rotational axis of the outer housing may be desired. In
some embodiments, the outer housing is formed by a sidewall that is
tapered and/or has one or more steps.
[0062] In some preferred embodiments, the inner surface of the top
of the outer housing includes one or more inner housing engaging
elements or structures (e.g., teeth) designed to releasably engage
complementary structures in the outer housing-engaging region on
the top of the inner housing. Engagement of the outer housing's
inner housing engaging structure(s) with those in the outer
housing-engaging region of the inner housing allow a user to rotate
the outer housing and inner housing in unison, for example, as a
capping and cleansing device's inner housing is screwed onto the
threaded portion of a needlefree connector to be cleansed and/or
capped. Once the device is releasably secured to a needlefree
connector via the inner housing, the outer housing's inner housing
engaging elements or structure(s) can be (or are) disengaged from
the outer housing-engaging elements of the inner housing, for
example, by the biasing action or resilience of a the compressible
cleansing matrix, thereby allowing a user to rotate the outer
housing about its central axis in relation to the inner housing. A
representative example of such engaging structures is shown in
published US patent application publication no. 2018/0304067,
although features such as an inner housing having an opening in its
top to allow a compressible cleansing matrix attached to the inner
surface of the top of the outer housing to extend into the bore of
the inner housing so that it can contact surfaces of a needlefree
connector upon connection of the former to the latter are also
envisioned.
[0063] In some of these embodiments, the outer housing may include
one or more vents to allow fluid and/or air from inside the device
to escape as the capping and cleansing device is secured to a
needlefree connector, while in other embodiments, no vent(s) is
(are) provided. In embodiments with one or more vents, a membrane,
filter, or other permeable or semi-permeable barrier may be
employed to allow a unidirectional or bidirectional flow of air,
gas, or vapor through the vent(s) but prevent the movement of
microorganisms (e.g., bacteria, fungi, viruses, etc.) into the
capping and cleansing device of the invention.
[0064] In certain preferred embodiments, the outer surface of the
outer housing of a capping and cleansing device according to the
invention includes one or more grip-enhancing structures (e.g., a
plurality of vertical ridges) or coatings. Such grip-enhancing
structures or coatings facilitate a user's grasp of the housing of
a capping and cleansing device between her/his fingers, which can
be helpful not only during insertion and removal of a needlefree
connector from the capping cleansing device, but also during the
cleansing process, where the user rotates the outer housing in
relation to the inner housing in order to scrub and thereby clean
or cleanse the surface(s) of the inserted needlefree connector with
the compressible cleansing matrix of the device.
[0065] In some preferred embodiments, the devices of the invention
include one or more elements or features arrayed on facing surfaces
of the inner and outer housings that allow a user to sense that the
outer housing is rotating in relation to the inner housing in order
to provide cleansing action on the valve surface of the NC to which
the device is attached. Such sensory feedback can include one or
more of auditory, tactile, and/or visual stimuli generated from the
device by rotation of the outer housing in relation to the inner
housing.
[0066] In some of these embodiments, the devices of the invention
comprise a resilient inner body disposed within a cap that can be
rotated or turned in relation thereto when the capping and
cleansing device is secured to a needlefree connector, and a
compressible matrix element containing one or more antimicrobial
reagents and having a structure to allow capped surfaces of the
needlefree connector to be cleansed. More specifically, the
resilient inner body has a wall that forms a central, interior
(preferably cylindrical) bore that extends between oppositely
disposed first and second (or upper and lower, respectively)
openings. The interior wall of the central bore nearer the second
(lower) opening includes one or more thread-engaging tabs (or
threads), preferably two thread-engaging tabs disposed opposite to
each other. The thread-engaging tab(s) (or threads) is (are) are
configured to engage a complementary threaded region on the
exterior surface of, for example, a needlefree medical valve. This
allows the capping and cleansing device to be securely threaded
onto the targeted threaded portion of a needlefree connector for
cleansing and, if desired, capping that portion of the needlefree
connector. The exterior surface of the resilient inner body
includes one or more structures that allow it to mechanically
engage and disengage complementary structures disposed on an inner
surface of the cap.
[0067] In many embodiments, the resilient inner body's exterior
surface includes a cap-engaging region that includes one or more
structures such as spaced protrusions (e.g., teeth) that allow the
resilient inner body to mechanically engage and disengage
complementary engaging structures on an interior surface of the
cap. Preferred embodiments of cap-engaging structures include
alternating teeth and grooves (or channels) arrayed about the outer
circumference of the resilient inner body, which teeth and grooves
are complementary to one or more spaced engaging structures (e.g.,
teeth) disposed on the inner surface of the cap's outer wall. In
other embodiments, the cap-engaging region of the resilient inner
body is disposed on its inner surface for engagement with one or
more complementary engaging structures (e.g., teeth) arrayed on the
exterior or outer surface of matrix well wall. As will be
appreciated, in configurations that include teeth and channels, the
"teeth" can be raised protrusions and the "channels" can be the
spaces or gaps between the raised protrusions.
[0068] The resilient inner body also includes a compressible
region. In many preferred embodiments, it is located above the
thread-engaging tab(s) (or threads) and cap-engaging region. The
compressible region can be any structure that allows the resilient
inner body to be compressed so as to bring the first and second
openings closer together to allow disengagement of the engaging
structures of the cap and resilient inner body. In preferred
embodiments, the compressible region is a torsion spring, which in
certain particularly preferred embodiments is a molded torsion
spring formed from a plastic or other sufficiently flexible or
resilient material, preferably during injection molding, as part of
the resilient inner body.
[0069] In some embodiments, the resilient inner body is made from
two or parts that are then assembled to form the complete inner
body. For example, a resilient inner body can be formed as two or
more separate parts that are assembled, one on top of the other,
during manufacture of the capping and cleansing device of the
invention. For instance, in embodiments where the resilient inner
body is made of two parts, the upper part preferably comprises the
compressible region (e.g., a torsion spring formed during injection
molding of the upper part), while the lower part comprises the
cap-engaging region and the thread-engaging tab(s) (or threads). In
contrast, a representative three-part embodiment of a resilient
inner body includes an upper section that comprises the first
(upper) opening and the compressible region, a midsection that
comprises the cap-engaging region, and a lower section that
includes the thread-engaging tab(s) (or threads) and second (lower)
opening. In an alternative three-part embodiment, the upper section
comprises the first (upper) opening and cap-engaging region, the
midsection comprises the compressible region, and the lower section
includes the thread-engaging tab(s) (or threads) and second (lower)
opening. As will be appreciated, the invention encompasses all
possible combinations of parts having a cap-engaging region,
compressible region, and a region to engage the threads of the
threaded portion of a needlefree connector, with the proviso that
the final combination be capable of being compressed to provide
cap-engaging and -disengaging functionality such that when
corresponding structures on the cap and inner body are engaged, the
cap and inner body can rotate together about their central axes,
and when the corresponding structures on the cap and inner body are
disengaged by compression of the compressible region, a user can
rotate the cap about its central axis in relation to, or
independently from (i.e., the cap spins while the resilient inner
body does not), the resilient inner body.
[0070] In embodiments of the invention where the resilient inner
body is made from two or more parts, those parts, once assembled,
preferably are mechanically connected such that they, too, move in
unison, for example, when the capping and cleansing device of which
they are a part is threaded onto the threaded portion of a
needlefree connector, for example, a needlefree connector. Any
suitable mechanical lock, and corresponding set of mechanical
structures, can be used to link such parts together.
[0071] In some preferred embodiments, the inner housing or
resilient inner body also includes a sealing member (i.e., seal)
configured to provide a fluid tight seal between the capping and
cleansing device of the invention and an NC connected thereto. The
seal is preferably disposed in a channel formed in the inner
surface of the wall of the resilient inner body proximate to the
second (lower) opening, typically below the thread-engaging tab(s)
(or threads).
[0072] Each device of the invention also includes a outer housing
or cap in operable association with the inner housing such as a
resilient inner body. A cap typically includes an outer cavity
formed by a curved outer wall that is joined to a top portion,
preferably about the top portion's periphery, and a preferably
concentric central matrix well that extends from the top's inner
surface into the outer cavity. The wall forming the matrix well is
spaced from the cap's outer wall to form a resilient member housing
that can be accessed through an opening created by the gap between
the cap's wall and the matrix well wall. In many preferred
embodiments, the inner surface of the cap's outer wall includes one
or more engaging or locking structures (e.g., teeth) designed to
releasably engage (i.e., corresponding structures can be engaged
and disengaged, as desired) complementary structures in the
cap-engaging region of the resilient inner body. In other
embodiments, the cap's engaging or locking structure(s) is (are)
disposed on the outer surface of the matrix well wall, which
locking structure(s) is (are) designed to releasably engage
complementary structures in the cap-engaging region on the inner
wall of the resilient inner body. Engagement of cap's engaging or
locking structure(s) with those in the cap-engaging region of the
resilient inner body allows a user to rotate the cap and resilient
inner body in unison, for example, as a capping and cleansing cap
is screwed onto the threaded portion of a needlefree connector to
be cleansed and/or capped. Once the device is releasably secured to
a needlefree connector, the cap's locking structure(s) can be
disengaged from those in the cap-engaging region of the resilient
inner body, thereby allowing a user to rotate the cap about its
central axis in relation to the resilient inner body. In some
embodiments, the cap may include one or more vents to allow fluid
and/or air from inside the device to escape as the capping and
cleansing device is secured to a needlefree connector, while in
other embodiments, no vent(s) is (are) provided.
[0073] The capping and cleansing devices of the invention also
include a compressible cleansing matrix in the outer housing's
matrix well. The compressible cleansing matrix can be, for example,
an open-cell foam. The cleansing matrix is preferably secured to an
inner surface of the outer housing so as to limit or restrict its
rotation independent of the outer housing during outer housing
rotation. The compressible cleansing matrix is configured to
contact and cleanse one or more surfaces of a needlefree connector
that contacts the matrix upon a needlefree connector's association
with a capping and cleansing device of the invention. The
compressible cleansing matrix attached to or otherwise associated
with the outer housing can be axially compressed (i.e., compressed
along the central axis of the outer housing's matrix well) upon
insertion of a needlefree connector into a capping and cleansing
device.
[0074] Because the needlefree connector surface(s) to be cleansed
may be contaminated with microorganisms that form a biofilm (i.e.,
a matrix of microorganisms and extracellular material attached to a
surface, which enables the microorganisms, typically bacteria
and/or fungi, to adhere to a surface and carry out certain
biochemical processes), the compressible cleansing matrix
preferably has sufficient mechanical integrity when compressed to
allow its use to disrupt any biofilm that may be present on a
surface of the needlefree connector that is contacted by the
cleansing matrix. Disruption of biofilm can occur by rotating,
twisting, or otherwise moving a then-compressed cleansing matrix in
relation to the needlefree connector (e.g., a needlefree medical
valve), for example, by rotating the outer housing (to which the
compressible cleansing matrix is attached or otherwise associated
or retained) in relation to the inner housing (e.g., a resilient
inner body) of the capping and cleansing device and the needlefree
connector to which inner housing is releasably attached. The
resulting friction between the compressed cleansing matrix and
surface of the needlefree connector disrupts the biofilm, thereby
cleansing, and preferably sterilizing, the needlefree connector.
Leaving the capping and cleansing device secured to (i.e., capping)
the needlefree connector after such cleansing will limit, and
preferably preclude, biofilm regrowth and/or the microbial
recolonization of cleansed surfaces (which remain in contact with
the compressible cleansing matrix) of the needlefree connector.
[0075] In preferred embodiments, the compressible cleansing matrix
includes one or more cleansing reagent species dispersed therein,
preferably at the time the device is manufactured, although in some
embodiments, the cleansing reagent may be dispersed into the matrix
just prior to the matrix coming into contact with a needlefree
connector. In embodiments of the latter sort, the cleansing reagent
is preferably housed in the body of the capping and cleansing
device in a reservoir configured to rupture upon association of a
needlefree connector for cleansing. Such a reservoir can be
disposed between the matrix and needlefree connector, or, more
preferably, between the rotatable cap and compressible cleansing
matrix. Preferred cleansing reagents include antimicrobial reagents
such as isopropyl alcohol, chlorhexidine, and silver ions. In some
embodiments, the capping and cleansing device of the invention will
include a valve or opening to allow liquid in the cleansing reagent
to evaporate.
[0076] In some preferred embodiments, the compressible cleansing
matrix is comprised of two or more components. In some of such
embodiments, one portion of the matrix is attached to the inner
surface of the outer housing and another portion is secured to the
inner surface of the wall forming the matrix well. If present, the
portion of the compressible cleansing matrix secured to the inner
surface of the matrix well wall is preferably configured to
radially compress upon association with a needlefree connector to
be capped and cleansed. When a cleansing matrix is comprised of two
or more components, the matrix components may be made from the same
of different material(s).
[0077] As described, the central matrix well is adapted to receive
the compressible cleansing matrix. The surface(s) of the central
matrix well in contact with the matrix preferably includes one or
more retaining structures to retain the compressible cleansing
matrix so as to link its rotation or movement to that of the cap,
particularly when the engaging structures of the cap and resilient
inner body are disengaged so as to allow cap rotation during a
needlefree connector cleansing procedure. Such retaining structures
include ridges and other protrusions from the surface of central
matrix well in contact with the compressible cleansing matrix. An
adhesive can also be used to adhere that portion of the
compressible cleansing matrix to a desired position in the matrix
well.
[0078] In various embodiments, the outer surface of the outer
housing of a capping and cleansing device according to the
invention includes one or more grip-enhancing structures or
coatings, e.g., a plurality of vertical ridges. Such grip-enhancing
structures or coatings facilitate a user's grasp of the body of a
capping and cleansing device between her/his fingers, which can be
helpful not only during insertion and removal of a needlefree
connector from the capping cleansing device, but also during the
cleansing process, where the user rotates the outer housing in
relation to the inner housing in order to scrub and thereby
clean/cleanse the surface(s) of the inserted needlefree connector
with the compressible cleansing matrix.
[0079] The inner and outer housings can be made from any suitable
material or combinations of different materials. Plastics are
particularly preferred. The material(s) used to manufacture the
outer housing may be the same or different as the material(s) used
to produce the inner housing.
[0080] The outer housing and its various components are preferably
formed as a single, integral unit during manufacturing (e.g., by
injection molding). The inner and outer housings can be
manufactured by any suitable process, including extrusion,
injection molding, and additive manufacturing (e.g., 3D printing).
After manufacturing, an inner housing is inserted into an outer
housing to form a capping and cleansing device of the invention.
For securing the inner and outer housings together as a functional
subassembly that can transition between engaged and disengaged
configurations to provide for unitary or independent rotation of
the outer housing in relation to the inner housing, any suitable
retaining structure, or group of structures, that provides for
movement, i.e., rotation, of the outer housing in relation to the
inner housing can be used. Such structures include attachment
mechanisms such as "snap-fit" mechanisms where interacting parts
are sufficiently flexible and have preferably have tapered surfaces
so facilitate assembly.
[0081] A compressible cleansing matrix can be positioned in the
matrix well before of after an inner housing and outer housing are
operably associated. In preferred embodiments, a suitable adhesive
is used to securely adhere the compressible cleansing matrix, or,
if the matrix comprises two or more parts, its various portions, to
one or more inner surfaces of the outer housing's matrix well. In
some embodiments, the surface of the matrix well that contacts the
compressible matrix includes a structure to assist in securely
retaining the matrix in the well, thus ensuring that it moves in
conjunction with the cap when the outer housing is rotated during a
cleansing procedure.
[0082] In preferred embodiments, the capping and cleansing devices
include a removable lid or seal attached to the outer housing to
seal the device, thus separating the interior spaces and structures
of the device from the external environment. Such a lid or seal
prevents exposure of the devices's interior, including the inner
housing and compressible cleansing matrix, to the environment until
the seal is removed, typically by a healthcare worker just prior to
her/his use of the capping and cleansing device to cap and then, if
desired, to clean/cleanse the needlefree connector (e.g.,
needlefree medical valve) to which it is connected. In preferred
embodiments, such cleansing substantially disrupts any biofilm that
may exist on surfaces contacted by the compressible cleansing
matrix. If desired, the capping and cleansing device can be left in
place (typically after cleansing the needlefree connector attached
thereto) in order to cap the needlefree connector until it is
further accessed, thereby minimizing exposure of capped exterior
surfaces of the connector to potential pathogen contamination (and
biofilm formation) from the surrounding environment. Seals are
typically installed during manufacture of a capping and cleansing
device of the invention. In those embodiments where the capping and
cleansing devices are sterilized during manufacture (e.g., by
irradiation, exposure to ethylene oxide, etc.), seals are
preferably applied prior to sterilization.
[0083] Other aspects of the invention concern methods of cleansing
and/or capping needlefree connectors using a capping and cleansing
device according to the invention. Such methods typically involve
transitioning the inner and outer housings from an engaged to a
disengaged configuration after the device has been connected to a
needlefree connector as to allow the outer housing to spin or
rotate in relation to the inner housing. Such compression
facilitates contact between the device's compressible cleansing
matrix and the associated surface(s) of the needlefree connector.
Spinning or rotation of the outer housing in relation to the inner
housing, and the associated surface(s) of the needlefree connector,
allow those surfaces to be scrubbed, thereby cleansing them.
Preferably, such cleansing methods provide for the disruption of
any biofilm present on the surface(s) of the needlefree connector
associated the capping and cleansing device. And in those
embodiments where the compressible cleansing matrix contains one or
more antimicrobial reagents, microbes and pathogens present in such
biofilm and/on on such surface(s) are destroyed or rendered
nonviable.
[0084] Herein, the compressible cleansing matrix of a capping and
cleansing device of the invention comprises one or more cleansing
reagent species dispersed in a substrate. The cleansing matrix
substrate can be any substance that can conform, mold, or compress
in a manner that enables the effective friction-based cleansing of
the site or portion of the needlefree connector to be cleansed,
including the top surface of the site, side surface, and any
threads or grooves, if present, and provide the cleansing reagent
at least at a surface level. Examples of the compressible cleansing
matrix include cotton, open or closed cell foam such as
polyethylene foam, or other substance that can hold or carry the
cleansing reagent.
[0085] In some embodiments, the cleansing reagent species is (are)
dispersed in or otherwise combined with the compressible cleansing
matrix during the process used to manufacture the capping and
cleansing device, while in other embodiments, the device is
configured such that the cleansing reagent(s) is (are) released for
dispersion into the compressible cleansing matrix post-manufacture,
but when or prior to the time the matrix is brought into contact
with the needlefree connector to be cleansed. The cleansing reagent
can be any chemical, substance, or material that cleans the site of
bacterial or even viral microorganisms, biofilm, etc., or any
carrier that contains such chemical, substance or material.
Examples of cleansing reagents include isopropyl alcohol,
chlorhexidine, chlorhexidine digluconate, povidone-iodine, hydrogen
peroxide, soap, and hydrochloric acid, silver ions and salts (e.g.,
silver acetate, silver lactate, silver nitrate, etc.), etc.
[0086] In accordance with the invention, a cleansing reagent
comprises an active ingredient capable of cleansing a surface of a
needlefree connector. Any active ingredient that can be used
effectively to rapidly cleanse a medical fitting or medical line
connector (e.g., a needlefree connector) can be adapted for use in
practicing the invention, and are generally classified as
antibacterial and/or antifungal reagents, antiseptic or
antimicrobial reagents, wide spectrum disinfectants, and/or
parasiticides, as well as combinations of such reagents.
Particularly preferred are biocompatible cleansing reagents, as the
devices of the invention are intended for human and/or veterinary
use, including alcohols, antibiotics, oxidizing reagents, and metal
salts. Representative examples of such active ingredients include
bleach, chlorhexidine, ethanol, isopropyl alcohol, hydrogen
peroxide, sodium hydroxide, and an iodophor dissolved or otherwise
dispersed in a suitable solution, suspension, or emulsion. Other
active ingredients having suitable cleansing effects can also be
used. These include alcohols (e.g., ethanol, benzyl alcohol,
isopropyl alcohol, phenoxyethanol, phenethyl alcohol, etc.);
antibiotics (e.g., aminoglycosides, such as amikacin, apramycin,
gentamicin, kanamycin, neomycin, netilmicin, paromomycin,
rhodostreptomycin, streptomycin, and tobramycin; bacitracin;
chloramphenicol; erythromycin; minocycline/rifampin; tetracycline;
quinolones such as oxolinic acid, norfloxacin, nalidixic acid,
pefloxacin, enoxacin and ciprofloxacin; penicillins such as
oxacillin and pipracil; nonoxynol 9; fusidic acid; cephalosporins;
etc.), quaternary ammonium chlorides; quaternary ammonium
carbonates; benzalkonium chloride; chlorinated phenols; fatty acid
monoesters of glycerin and propylene glycol; iodine; iodine
containing compounds, such as 3-iodo-2-propynyl butyl carbamate
(IPBC); iodophors, such as povidone-iodine (Betadine 100%, which
contains providine iodine as the active ingredient); hydantoins,
such as dimethylhydantoin and halogenated hydantoins;
isothiazolinones; parabens, such as methylparaben, ethylparaben,
and propylparaben; chloroxylenol; chlorhexidine and its salts;
chlorhexidine/silver-sulfadiazine; chlorhexidine acetate;
chlorhexidine gluconate (e.g., Hibiclens); chlorhexidine
hydrochloride; chlorhexidine sulfate; benzoic acid and salts
thereof; benzalkonium chloride; benzethonium chloride;
methylbenzethonium chloride; chlorobutanol; sorbic acid and salts
thereof; imidazole antifungals (e.g., miconazole); butocouazole
nitrate; mafenide acetate; nitrofurazone; nitromersol;
triclocarban; phenylmercuric nitrate or acetate (0.002%);
chlorocresol; chlorbutol; clindamycin; CAE (Anjinomoto Co., Inc.,
containing DL-pyrrolidone carboxylic acid salt of L-cocoyl arginine
ethyl ester); cetylpyridinium chloride (CPC) at 0.2%, 0.02%, and
0.002% concentrations; 9.8% isopropyl alcohol; 1% ZnEDTA;
mupirocin; and polymyxin (polymyxin b sulfate-bacitracin).
Additionally, other useful compounds and compositions include
Miconazole, Econazole, Ketoconazole, Oxiconizole, Haloprogin,
Clotrimazole, butenafine HC1, Naftifine, Rifampicin, Terbinafine,
Ciclopirox, Tolnaftate, Lindane, Lamisil, Fluconazole, Amphotericin
B, Ciprofloxecin, Octenidine, Triclosan
(2,4,4'-trichloro-2'-hydroxydiphenyl ether), Microban
(5-chloro-2phenol (2,4 dichlorophenoxy). Useful metals include
silver and its salts, including silver acetate, silver benzoate,
silver carbonate, silver citrate, silver iodate, silver iodide,
silver lactate, silver laurate, silver nitrate, silver oxide,
silver palmitate, silver protein, and silver sulfadiazine.
Cleansing reagents are often compositions that comprise the desired
active ingredient(s) in admixture with other ingredients, such as
carriers and liquid solvents.
[0087] The particular active ingredient(s) selected as a cleansing
reagent for a given application will be compatible with the
compressible cleansing matrix and material(s) used to form the
outer housing, inner housing, and other components of the
particular device. In some embodiments, the cleansing reagent is
dispersed in the compressible cleansing matrix after the matrix is
formed. For example, a cleansing reagent can be dispersed by
saturating or supersaturating a compressible cleansing matrix
during manufacture of the device, preferably before it is sealed.
In other embodiments, the cleansing reagent can be dispersed during
the process used to manufacture the compressible cleansing matrix.
As will be appreciated, the materials used to prepare the cleansing
reagent should be compatible with the constituent or constituents
that comprise the compressible cleansing matrix such that the
substrate does not appreciably degrade or otherwise suffer loss of
structural integrity prior to being used to cleanse a needlefree
connector (e.g., a needlefree medical valve). Similarly, the
cleansing reagent should be biocompatible, such that it will not
harm a patient in the event of contact or should some amount of the
cleansing reagent be admitted into the fluid-carrying portion of a
needlefree medical valve, as well as with materials used to form
needlefree medical valves (or other needlefree connector).
[0088] In preferred embodiments, the material used to form the
compressible cleansing matrix is any suitable absorbent, compliant,
pliable, resilient, fibrous, or porous material, or combination of
materials, than can be wetted and/or impregnated with a cleansing
reagent and which can easily and readily adapt to complex surface
contours (e.g., luer threads, concave and convex surfaces, flanges,
etc.) likely to be engaged upon contact with, for example, a
needlefree medical valve to be cleansed. Such materials include
those that are synthetic or naturally occurring, and they may be of
homogeneous or heterogeneous composition. Preferred synthetic
materials include fibrous, foam (e.g., a felted foam), and gel
compositions, particularly those having directionally oriented
natural or synthetic fibers, or combinations thereof. Preferred
naturally occurring materials useful as substrates include fibrous
naturally occurring materials, including plant-derived materials
such as cotton and paper products, as well as animal-based fiber
products such as wool. Other preferred natural materials are
sponges.
[0089] As will be appreciated, in order to achieve the desired
cleansing effect, a compressible cleansing matrix, or the component
part(s) thereof designed to contact a needlefree connector such as
a needlefree medical valve, preferably are made of a material (or
combination of materials) that allow the cleansing element to
thoroughly cleanse surfaces of needlefree connectors such as
needlefree valves or luer access devices, particularly those
surfaces that are exposed to air and thus are at risk for
contamination with infectious or pathogenic reagents, and biofilms
containing the same, and are also intended to form part of the
fluid flow path for fluids to be introduced into a patient, for
example, IV solutions, medications, blood and blood products,
etc.
[0090] Preferably, the material used to produce the compressible
cleansing matrix should be sufficiently compliant to allow the
compressible cleansing matrix to deform under the pressures
experienced during normal use in order to allow it to conform to
the external structures present on the surface(s) of the needlefree
connector to be cleansed. This assures intimate, cleansing contact
between the compressible cleansing matrix and at least those
exposed surfaces of, for instance, a needlefree connector designed
to come into contact with fluid entering the valve, such as IV
fluids. In addition, the compressible cleansing matrix preferably
allows for the retention of a liquid cleansing reagent, for
example, in capillary spaces, in the void volume of foams, sponges,
etc. The compressible cleansing matrix may also be engineered such
that it includes cleansing reagents such as silver ions and/or
other suitable materials.
[0091] Preferred natural materials from which compressible
cleansing matrices can be formed include those derived from cotton
and naturally occurring sponges. As those in the art appreciate,
processed cotton fibers are composed almost entirely of the natural
polymer cellulose. In such fibers, 20-30 layers of cellulose are
coiled into a series of spring configurations, which makes the
fibers absorbent and gives them a high degree of durability and
strength. For example, woven cotton sheets, as are often used in
the manufacture of sterile cleansing pads that are then saturated
with a 70% isopropyl alcohol (IPA) solution, can be used as
substrates for cleansing elements according to the invention. Any
suitable configuration may be used. For example, a woven cotton
sheet can be cut into numerous similarly sized pieces, each of
which can be used as a substrate. In many embodiments, after
attachment to the inside surface of a layer of the container (e.g.,
through the use of an adhesive, double-sided, tape, etc.), the
matrix is ready for the addition of a suitable cleansing reagent.
Alternatively, cotton fibers can be spun onto the inside surface of
the cap. Other fibers, be they naturally occurring, synthetic, or
combinations of natural and synthetic materials, having similar
properties can also readily be adapted for use as compressible
cleansing matrices.
[0092] Another class of materials for compressible cleansing matrix
fabrication is directionally oriented fibrous materials. These
include, without limitation, materials comprised of cellulose
fibers, glass fibers, and polyester fibers, as well as materials
comprised of combinations of two of more of these and/or other
materials. Such bonded synthetic fibers use capillary action to
precisely absorb, retain, transfer, and/or release liquids or vapor
in desired amounts. A broad range of synthetic polymers can be used
to form the fibers, and, if desired, they may be treated for
functional purposes, for example, to contain a cleansing reagent
dispersed therein, to provide a vapor barrier or other coating over
a portion of the product's surface, etc. The geometric shape of
these materials can also be customized for particular applications,
thereby permitting easy integration into substrate configurations
having the desired device thickness, widths, length, diameter,
etc.
[0093] Other representative classes of materials suitable for use
as compressible cleansing matrices include gel-forming polymers and
foams such as agarose, agar, polyacrylamide, and other synthetic
porous materials that can be formed into layers, sheets, columns,
or other shapes compatible with practicing the invention.
Representative gelatinous materials include hydrogels (i.e.,
cross-linked polymers that absorb and hold water), particularly
those made from agarose, (2-hydroxyethyl)methacrylate and its
derivatives, and synthetic carbohydrate acrylamides.
[0094] Still other classes of materials include porous polymer
sponges. Such sponges can be formed from any suitable material,
including polyethylene, polypropylene, polytetrafluoroethylene,
polyvinylidine difluoride, polynitrile, and polystyrene. Many such
porous polymer sponges are commercially available in a wide variety
of shapes, pore density and size, etc. Additionally, polymer
sponges can be made by polymerizing appropriate monomers according
to conventional foam forming techniques. In general, sponges have
an open pore structure to allow movement of a solvent such as a
liquid cleansing reagent. The sponge surface should include open
pores to provide entry of liquid cleansing reagents (e.g., alcohol,
iodine-containing solutions, etc.), and, as with other materials
used to form matrices, the particular material chosen is preferably
inert, i.e., not reactive with components of the cleansing reagent,
the body of the capping and cleansing device, or the materials used
to produce needlefree connectors such as needlefree medical
valves.
[0095] Surgical foams are another preferred class of materials that
can be used to make compressible cleansing matrices. The materials
can be natural or synthetic, as desired. Suitable foams include
rubber latex, polyurethane, polyethylene and vinyl foams.
Preferably, such foams are made from any suitable biocompatible
polymer, for example, polyvinyl alcohol (PVA) or polyurethane. One
preferred foam material is Microbisan.TM., a hydrophilic
polyurethane foam that is impregnated with silver ions (Lendell
Manufacturing, St. Charles, Mich.). Preferably, such foams are
highly absorbent and thus suitable for use with liquid cleansing
reagents. In other embodiments, the material used to form the foam
is well-suited for dispersion of a dry cleansing reagent, such as
silver ions. Again, it is preferred that foam materials, if used to
as a substrate, be inert. Also, they are preferably sufficiently
flexible to conform to the variety of different shapes and surface
configurations (e.g., double seal fluid access points, luer
threads, etc.) encountered in the field given the multitude of
medical valve shapes, sizes, and configurations. In this way
sufficient contact between the cleansing surface(s) of the capping
and cleansing device and the surface(s) of the needlefree connector
to be cleansed can be ensured. Another advantage of some synthetic
foams (as well as certain other polymeric materials from which
substrates may be formed) is that they can easily be injected in a
desired volume into a shell or housing during manufacture, after
which they expand to assume the desired substrate size, density,
porosity, etc.
[0096] Furthermore, compressible cleansing matrices can include
chemicals to indicate a functional change therein, for example, by
using a color change to signal a change from a wet to a dry state,
or, alternatively, that the matrix material has been properly
wetted with a liquid cleansing reagent dispersed into the substrate
by a health care worker just prior to use, as opposed to during
manufacture of the device. Thus, depending on the system used, a
color change in the matrix could be used to indicate that the
cleansing reagent in the compressible cleansing matrix has
evaporated prior to use and thus the particular cleansing device
should not be used, perhaps due to a leak in the capping and
cleansing device's storage container. Alternatively, when, for
example, a colored liquid cleansing reagent is used, the user can
visually confirm dispersion of the reagent in the matrix by
assessing whether the colored cleansing reagent is dispersed
throughout the matrix. When colored cleansing reagents are used, it
is preferred that the material(s) use to make the resilient inner
body and/or cap of the capping and cleansing device be clear or
translucent, or include one or more clear or translucent windows,
in order to allow easy visualization of any color change prior to
or during use of the capping and cleansing device.
[0097] Capping and cleansing devices of the invention and their
constituent parts (e.g., the resilient inner body, cap,
compressible cleansing matrix, sealing ring, seal, etc.) can be
made from any suitable material(s) and assembled using any suitable
process.
[0098] Preferably, the outer surface of a capping and cleansing
device's outer housing intended for grasping by a user has a
non-slip surface, i.e., one having a high coefficient of friction
so that when the outer portion of a capping and cleansing device is
held in a user's fingers and positioned to cleanse a needlefree
connector so that the outer housing can be rotated in relation to
the inner housing and needlefree connector with minimal or no
slippage between the device and the user's fingers (gloved or
ungloved). Examples of such non-slip (or high friction) surfaces
include those having ridges, valleys, dimples, bumps, or other
features designed to enhance friction, as well as combinations of
two or more of such features. Such features can be introduced into
a device's outer surface(s) as part of the manufacturing process.
Alternatively, a non-slip coating can be applied to one or more of
the outer surfaces of the outer housing.
[0099] In general, the capping and cleansing devices of the
invention are provided to users in a sealed, sterile manner. If
desired, labeling information, logos, artwork, manufacturing,
and/or regulatory data (e.g., lot number, expiration or "use by"
dates, etc.) may also be printed or otherwise applied to individual
capping and cleansing devices. In addition, information such as a
bar code (to allow use of the device to tracked, for example) may
also be included on individual capping and cleansing devices.
[0100] As will be appreciated, cleansing devices may be packaged
individually or in groups of two or more units as kits, which can
further include instructions for use of the capping and cleansing
device(s), as well as other information, logos, artwork,
manufacturing, and/or regulatory data.
[0101] In preferred embodiments, packaged capping and cleansing
devices are sterilized using a suitable process, such as
irradiation. In a particularly preferred practice, the capping and
cleansing device s of the invention are sterilized as part of the
manufacturing process. Here, "sterilization" refers to any process
that effectively kills or eliminates transmissible reagents, e.g.,
bacteria, viruses, fungi, prions, spores, etc. that may be present
in any component of a device according to the invention. In
preferred embodiments, sterilization can be achieved by heating,
chemical treatment, irradiation, and other processes. Indeed, any
sterilization process compatible with the materials used to make
the capping and cleansing device can be employed. A particularly
preferred sterilization process is an irradiation process. Such
processes include irradiation with x-rays, gamma rays, or subatomic
particles (e.g., an electron beam). In general, when a
sterilization process is used in the context of the invention, the
process is employed on a cleansing article after it has been sealed
and/or packaged. Chemical sterilization processes can also be used,
for example, sterilization using ethylene oxide (EtO).
[0102] The invention also concerns methods of using the instant
single-use capping and cleansing devices of the invention. Such
methods include using the devices to cleanse and, if desired, cap
needlefree connectors such as needlefree connectors, luer access
devices, and the like. To perform such methods, the portion of a
needlefree connector to be cleansed is threaded into the central
bore of the inner housing of a capping and cleansing device,
typically after the user (e.g., a nurse) removes a seal that spans
the opening in the device. Such insertion brings the site of the
needlefree connector into contact with (i.e., brought into
cleansing association with) the compressible cleansing matrix
portion(s) of the device. In preferred practice, once the
compressible cleansing matrix is in contact with the surface(s) of
the needlefree connector to be cleansed, the outer housing
automatically disengages the engaging elements in the inner and
outer housings to allow rotation of the outer housing in relation
to the inner housing and needlefree connector previously releasably
connected to capping and cleansing device. Such contact and
cleansing action can be for any desired period, with periods of
about one second to about ten to twenty seconds being particularly
preferred.
[0103] After cleansing, the needlefree connector can be removed
from the capping and cleansing device, after which the capping and
cleansing device may be discarded. Alternatively, after cleansing,
the capping and cleansing device can be left attached to the
needlefree connector, capping a portion thereof until such time as
access to the needlefree connector is desired, capping it and
protecting it from contamination. At that time, the capping and
cleansing device can be removed and discarded. If desired, just
prior to removal, a cleansing process can be repeated.
[0104] After removal of a capping and cleansing device from a
cleansed needlefree connector, a fluid-containing medical reservoir
(e.g., a syringe containing a medication, an IV bag, etc.) may be
immediately connected to the cleansed needlefree connector. In
preferred embodiments where the cleansing reagent is a solution,
the surface(s) of the needlefree connector is preferably allowed to
dry (or is (are) dried, for example, by wiping with a sterile,
absorbent cloth or wipe, which cloth or wipe may be dry or wetted
with a volatile, compatible solution such as 70-100% alcohol) prior
to connecting the needlefree connector to a fluid reservoir. In
preferred practice, such cleansing methods result in at least a
2-fold, 5-fold, or 10-fold or more reduction in microorganism
contamination on the accessible surface(s) that have been cleansed.
Even more preferably, the level of reduction may exceed a 100-fold,
a 10.sup.3-fold, a 10.sup.4-fold, a 10.sup.5-fold, a 10.sup.6-fold,
or 10.sup.7-fold reduction in microorganism contamination on the
accessible fitting surface.
[0105] In addition to methods for cleansing accessible surfaces of
luer access devices and the like, the devices of the invention
provide methods of reducing infection risk in a patient connected
to devices, such as a peripheral IV line, a central IV line, or a
peripherally inserted central catheter, configured for delivering
fluids directly into the patient's blood stream. The risk reduction
afforded by the devices of the invention may vary depending upon
many factors, such as patient age and condition, the condition
being treated, the location where medical services are being
delivered, patient density, the level of contaminating
microorganisms in the environment, the quality of air handling
equipment in the medical facility, the degree of training of
medical personnel charged with cleansing the access device, the
method(s) used to periodically cleanse the medical fitting,
intervals between cleansing procedures, the particular
configuration of the capping and cleansing device, the particular
configuration of the needlefree connector, whether the capping and
cleansing device is left on the cleansed site of the needlefree
connector in order to provide capping, etc. Risk reduction can be
established using any suitable method, for example, by assessing
HAI frequency in the presence and absence of using cleansing
devices according to the invention. Reductions of HAI infection
risk of 1-100% or more, including up to 1000% or more, are
envisioned through use of capping and cleansing devices according
to the invention. As will be appreciated, reductions in infection
risk (e.g., HAI risk) will translate to improved patient outcomes
(through reduced morbidity and mortality) and reduced expenditure
on treating HAI's.
REPRESENTATIVE EMBODIMENTS
[0106] To further illustrate and describe certain preferred,
representative embodiments of the invention, the reader is directed
to the appended drawings, FIGS. 1-10, which illustrate various
particularly preferred embodiments of the capping and cleansing
devices of invention. A description of these preferred,
representative embodiments follows.
[0107] FIG. 1 shows several drawings ((a)-(h)) of a representative
capping and cleansing device of the invention (10), its constituent
parts (views (b)-(h)), and the device associated with a needlefree
connector (view (a)). The constituent parts include a cap having a
cap portion (11) adapted to receive and retain the compressible
cleansing matrix (80) and a resilient inner body (30) associated
with the cap portion (11) and adapted to engage one or more
complementary features of the cap portion so as to prevent the cap
portion and resilient inner body from moving independently of each
other under certain conditions while under other conditions
allowing the cap portion (11) and to move independently of each
other. For example, after attaching the device (10) to a needlefree
connector (100) (producing a capped needlefree connector (200)), a
user an compress the resilient inner body (30) of the device (10)
by applying pressure to compress the cap (10) against the
needlefree connector (100) so as to allow the cap (10) to be
rotated in relation to the resilient inner body (30) and the
needlefree connector (100). Such action brings the compressible
cleansing matrix (80) and surface(s) of the needlefree connector
(100) desired to be cleaned, for example, the valve surface of a
needlefree medical valve, into contact, and rotation of the cap
(10) in relation to the needlefree connector (100) creates friction
that can disrupt, for example, biofilm that may be present on the
needlefree medical valve's valve surface, which surface can be in
the fluid path of fluids moving through the medical valve.
[0108] FIG. 2(a) is an exploded view of a representative capping
and cleansing device of the invention (10) and a needlefree
connector (100). Visible are the cap (10), including its cap
portion (11) into which the compressible cleansing matrix (80) and
resilient inner body (30) are positioned, and a luer-based
needlefree connector (100) that is a needlefree medical valve, the
male end (105) of which has a collar (101) and threads (102) for
connecting the valve to a female threaded portion of a
complementary luer fitting of another needlefree connector (not
shown). View (b) is a cross-section side view of the cap (10) shown
in view (a) while it was still sealed with a seal (90). As shown,
the cap portion (11), compressible cleansing matrix (80), and
resilient inner body (30) are operably assembled. The compressible
cleansing matrix (80) is preferably positioned in a matrix well
(12) formed into and protruding from the inner surface of the cap
portion (11). The height of the matrix well (12) should allow
retention of the compressible cleansing matrix (80), and in some
embodiments it can be sized to act as a stop that can bear against
the collar of a needlefree connector (100) to which the cap is
attached when the cap is compressed by a user and rotated to
cleanse desired surfaces of the needlefree connector (100).
[0109] Views (c) and (d) of FIG. 2 show the cap (10) threaded onto
the medical valve (100) in capping and cleansing configurations
(views (c) and (d), respectively). As shown in these views, the
compressible cleansing matrix (80) of the cap (10) bears against
the valve surface of the valve stem portion (103) of the medical
valve (100). In the capping view, view (c), the cap (and
compressible cleansing matrix (80)) is not compressed. The diameter
of the matrix well (12) allows the cap to slide over the threads
(102) of the medical valve (100) when the cap is pushed toward the
medical valve (100) by user wishing to cleanse the surface of the
valve stem portion (103). View (d) shows the cap (10) compressed
against the medical valve (100). User-induced compression results
in the cap portion (11) moving closer to the body of the medical
valve (100) by virtue of compression of the resilient inner body
(30) and compressible cleansing matrix (80). This motion also
results in disengagement of the complementary mechanical retaining
elements of the cap portion (11) and resilient inner body (30),
thus allowing the user to rotate cap portion (11) and the
compressible cleansing matrix (80) of the cap in relation to the
valve surface, thereby allowing cleansing of that surface.
[0110] FIG. 3 shows six different views of a representative capping
and cleansing device of the invention. Views (a)-(c) show the
device (10) in a static, non-compressed, non-rotable position,
where the cap portion (11) and resilient inner body (30) are
engaged such that the cap (10), and hence the compressible
cleansing matrix (80) associated therewith, cannot rotate in
relation to the device's resilient inner body (30). Views (d)-(f)
show the same representative device (10) with the cap portion (11)
and resilient inner body (30) in movable relation such that the cap
portion ((11), and the compressible cleansing matrix (80)
associated therewith) can be rotated in relation to the device's
resilient inner body (30). The inner surface of the resilient inner
body (30) includes one or more (preferably two) tabs (35) to engage
the threads of a needlefree connector (100). In the embodiments
shown in the Figures, the outer surface of the resilient inner body
(30) includes a plurality of teeth (33) or other structures spaced
about the resilient inner body's outer circumference designed to
engage complementary spaced structures (e.g., ribs (18)) spaced on
the inner surface of the cap portion (11). When the cap (10) is
uncompressed, the teeth (33) engage the ribs (18) and effectively
lock the cap portion (11) and resilient inner body (30) together so
that they rotate together. This enables the cap (10) to be
threaded, for example, onto a complementary luer fitting of a
needlefree connector using the tabs (35) on the inner surface of
the resilient inner body (30) in order to provide a capping
function (to remove the cap from the needlefree connector, the
process is reversed). To provide cleansing action, once secured to
the needlefree connector, the cap (10) can then be compressed by a
user, which pushes the cap portion (11) toward the needlefree
connector's fitting and compresses the compressible cleansing
matrix (80) against the surface(s) of the connector (100) to be
cleansed.
[0111] FIG. 4 shows views of the cap portion (11) of a
representative capping and cleansing device (10) of the invention.
View (a) shows a top view of the cap portion (11). Also visible on
portions of the outer surface of the cap portion (11) are ridges
and valleys that provide for enhanced friction, allowing a user to
better grip or grasp the cap (10). View (b) shows a side view of
the cap portion (11). View (c) shows a bottom view of the cap
portion (11). Visible in this embodiment are six ribs (or
protrusions) (18) evenly spaced (here, about 60 deg. on center)
about the circumference of cap portion's inner surface. The ribs
(18) are positioned and sized to engage complementary features on
the outer surface of the resilient inner body (30) (not shown). The
wall forming the matrix well (12) is also visible in this view.
View (d) shows a cross-sectional view of the cap portion (11). The
well (20) formed by the matrix well wall (12) that extends from the
inner surface of the upper portion of the cap portion (11) is also
represented, and is adapted to receive and retain the compressible
cleansing matrix (80). In preferred embodiments, an adhesive (not
shown) or other bonding reagent is used to adhere the compressible
cleansing matrix (80) inside the well (20). The well (20) is spaced
from the outer wall of the cap portion (11). The resulting space is
sized and adapted for insertion of the resilient inner body (30),
about which the cap portion (11) can be rotated when the
complementary retaining elements (e.g., ribs (18) and teeth (33))
of the cap portion (11). In the representative embodiment of the
inventive capping and cleansing device (10) depicted in the
Figures, the upper surface (19) of the retaining elements (18)
present in the cap portion (11) are designed to engage the lower
surface of the locking grooves (34) between the teeth (33).
[0112] FIG. 5 shows seven different views ((a)-(h)) of the
resilient inner body (30) of a representative capping and cleansing
device of the invention (10). Representative measurements of this
particular embodiment are shown on several of the views. Depicted
in this embodiment are two thread tabs (35) disposed on the inner
surface of the wall (36) of resilient inner body (30), 12 spaced
teeth (33) to engage 12 complementary retaining elements (e.g.,
ribs (18)) on the inner surface of the cap portion (11). The
resilient inner body (30) is adapted for compression by a user upon
application of a suitable force, and rebound upon relieving of such
pressure.
[0113] FIG. 6 shows five different views ((a)-(e)), three of which
show a compressible cleansing matrix portion (80) of a
representative capping and cleansing device of the invention (10).
Views (a)-(c) show top, side, and bottom views of this particular
compressible cleansing matrix (80). Preferably, the compressible
cleansing matrix (80) is adhered using an adhesive to the surface
of matrix well (20) of the cap portion (11). Views (d) and (e) of
FIG. 6 show bottom and side views of a seal portion (90) of a
representative capping and cleansing device of the invention. The
seal (90) is typically sized to seal or cover the opening that
allows access to the interior of the cap (10). Preferably, the seal
contains one or more removal tabs (91) configured to allow grasping
by a user such that the seal can be removed just prior to the
device being used to cap and/or cleanse a needlefree connector
(100). Preferably, the seal is adhered to the cap (10) using a
suitable adhesive (94) applied to the inside surface (92) of the
seal (90). The seal's outside surface (93) often will contain
alphanumeric characters, bar code information, or the like.
[0114] FIG. 7 (FIGS. 7A-7E) shows five different views of another
representative capping and cleansing device of the invention (300)
in which a user engages the inner and outer housings (320, 301) by
squeezing (or applying pressure using two or more fingers) the
outer housing (301), causing it to deform slightly and move inner
housing engaging elements (311) present on the inner surface of the
outer housing's sidewall so that one or more them (typically on
opposite sides of the outer housing (301)) engage outer housing
engaging elements (326) present on the exterior surface of the
inner housing (320) below the inner housing retaining element (322)
on the outer surface of inner housing's sidewall (321). The top of
the outer housing (309) integrates with the outer housing's
sidewall (302). FIG. 7A shows an exploded perspective view of the
device (outer housing (301), compressible cleansing matrix (305),
and inner housing (320)) and an NC (100) to which the device (300)
is to be connected (see FIGS. 7B, 7E). The NC (100) has threaded
valve region (105) that includes a collar (101) below the threaded
portion (102). The valve surface (110) is disposed on top of the
threaded valve region (105). In FIGS. 7A-7E, the valve is not
depicted.
[0115] FIG. 7B shows a perspective view of the assembled device
(300) depicted in FIG. 7A secured to the threaded region of the
valve portion (105) of the NC (100) depicted in FIG. 7A.
Preferably, the plastic used to injection mold the outer housing
(301) of the device (300) shown in this embodiment is softer than
the plastic used to mold the inner housing (302). Preferably, the
plastic used to form the outer housing is sufficiently pliable to
allow it to be squeezed by a user to allow engagement of between
the inner and outer housings' engaging elements (326, 311) for
purposes of attaching and removing the device (300) from the NC
(100) but resilient enough to allow the outer housing (301) to
return to its original shape and thus allow the inner and outer
housings' engaging elements (326, 311) to become disengaged. This
allows a user to rotate the outer housing (301) and matrix 305) in
relation to the NC (100) in order to cleanse its valve surface
(110) when a cleansing operation is performed, for example, by
rotating the device (300) without engaging the inner and outer
housings' engaging elements (326, 311) a sufficient period of time
(e.g., 1-15 seconds or more) and/or for a desired amount of
rotation (e.g., 360 to 3,600 or more degrees) in the same or
different directions.
[0116] FIG. 7C shows an exploded cross-section view of the
components depicted in FIG. 7A. In addition, the thin, flexible lip
seal (324) with a tapered profile integrated into the top surface
of the inner housing (320) is designed to engage with the sealing
surface (308) at the bottom of the matrix well, which includes a
matrix cavity (303) into which matrix retaining ribs (307) protrude
and allow rotational forces applied by a user to the device (300)
to be translated to the compressible cleansing matrix (305). The
threads (326) on the inner surface of the inner housing (320) are
designed to engage the complementary threads (102) in the threaded
region (105) of the NC (100).
[0117] As will be appreciated, and as shown in FIGS. 7C-7E, the
compressible cleansing matrix (305) is inserted into the matrix
well (303) during manufacture. The matrix (305) can be impregnated
with a cleansing reagent (e.g., silver ions), and in preferred
embodiments, a liquid disinfectant such as a 70% IPA solution. The
bearing surface (323) of the outer housing retaining element (322),
here a tapered flange molded as part of the inner housing (320)
during manufacture, is designed to ride on the complementary
bearing surfaces (310) disposed on the inner surface of the outer
housing's main cavity (304). The inner housing retaining elements
(306) of the outer housing (301) provide for retention of the inner
housing (320) in the outer housing's main cavity (304) after the
inner housing assembled into a functional subassembly with the
outer housing during manufacture. For example, the inner housing
may be urged into the outer housing with sufficient force to join
them into a functional subassembly ready for insertion of
compressible cleansing matrix (305) followed by instillation of a
liquid disinfectant (e.g., a 70% IPA solution), sealing, packaging,
and sterilization. The inner housing engaging elements (311)
present on the inner surface of the outer housing's sidewall (302)
allow the outer housing (302) to engage outer housing engaging
elements (326) on the adjacent outer surface of the inner housing
(320).
[0118] FIG. 7D, the cross section view shows the components of the
device of the invention (outer housing (301), compressible
cleansing matrix (305), and inner housing (320)) assembled into a
functional capping and cleansing device (300) ready for attachment
to the threaded region of the valve portion (105) of the NC
depicted in FIG. 7A. When the device (300) is attached to an NC
(100), the NC contacting surface of the matrix (305) contacts the
valve surface (110) of the NC, allowing that surface to be cleansed
by a user rotating the device (300) in relation to the NC. FIG. 7E
is a cross section showing the capping and cleansing device (300)
of the invention screwed onto the NC, which results compression of
the compressible cleansing matrix (305) against the NC's valve
surface (110).
[0119] FIG. 8 (FIGS. 8A-8E) shows five different views of another
representative capping and cleansing device of the invention. This
embodiment is similar to that depicted in FIG. 7 (FIGS. 7A-7E)m the
difference being that in the embodiment shown in FIG. 8 the seal is
not a lip seal (324) located on the inner housing (320) but a
tapered, downwardly extending seal (408) disposed on the bottom
surface of the component forming the matrix well (403) in the outer
housing (401).
[0120] FIG. 8A shows an exploded perspective view of this device
embodiment (400) (outer housing (401), compressible cleansing
matrix (405), and inner housing (420)) and an NC (100) to which the
device (400) is to be connected (see FIGS. 8B, 8E). FIG. 8B shows a
perspective view of the assembled device (400) depicted in FIG. 8A
secured to the threaded region of the valve portion (105) of the NC
depicted in FIG. 8A. FIG. 8C shows an exploded cross-section view
of the components depicted in FIG. 8A, while in FIG. 8D, the cross
section view shows the components of the device of the invention
(outer housing, compressible cleansing matrix, and inner housing)
assembled into a functional capping and cleansing device ready for
attachment to the threaded region of the valve portion of the NC
depicted in FIG. 8A. FIG. 8E is a cross section showing the capping
and cleansing device of the invention screwed onto the NC, which
results compression of the compressible matrix against the NC's
valve surface.
[0121] Specifically, FIG. 8 (FIGS. 8A-8E) shows five different
views of another representative capping and cleansing device of the
invention (400) in which a user engages the inner and outer
housings (420, 401) by squeezing (or applying pressure using two or
more fingers) the outer housing (401), causing it to deform
slightly and move inner housing engaging elements (411) present on
the inner surface of the outer housing's sidewall so that one or
more them (typically on opposite sides of the outer housing (401))
engage outer housing engaging elements (426) present on the
exterior surface of the inner housing (420) below the inner housing
retaining element (422) on the outer surface of inner housing's
sidewall (421). The top of the outer housing (409) integrates with
the outer housing's sidewall (402). FIG. 8A shows an exploded
perspective view of the device (outer housing (401), compressible
cleansing matrix (405), and inner housing (420)) and an NC (100) to
which the device (400) is to be connected (see FIGS. 8B, 8E). The
NC (100) has threaded valve region (105) that includes a collar
(101) below its threaded portion (102). The valve surface (110) is
disposed on top of the threaded valve region (105). In FIGS. 8A-8E,
the valve of the NC (100) is not depicted.
[0122] FIG. 8B shows a perspective view of the assembled device
(400) depicted in FIG. 8A secured to the threaded region of the
valve portion (105) of the NC (100) depicted in FIG. 8A.
Preferably, the plastic used to injection mold the outer housing
(401) of the device (400) shown in this embodiment is softer than
the plastic used to mold the inner housing (402). Preferably, the
plastic used to form the outer housing is sufficiently pliable to
allow it to be squeezed by a user to allow engagement of between
the inner and outer housings' engaging elements (426, 411) for
purposes of attaching and removing the device (400) from the NC
(100) but resilient enough to allow the outer housing (401) to
return to its original shape and thus allow the inner and outer
housings' engaging elements (426, 411) to become disengaged. This
allows a user to rotate the outer housing (401) and matrix 405) in
relation to the NC (100) in order to cleanse its valve surface
(110) when a cleansing operation is performed, for example, by
rotating the device (400) without engaging the inner and outer
housings' engaging elements (426, 411) a sufficient period of time
(e.g., 1-15 seconds or more) and/or for a desired amount of
rotation (e.g., 360 to 3,600 or more degrees) in the same or
different directions.
[0123] FIG. 8C shows an exploded cross-section view of the
components depicted in FIG. 8A. In this embodiment (400), a
tapered, downwardly extending seal element (408) is disposed on the
bottom surface of the component forming the matrix well (403) in
the outer housing (401). This seal (408) has a sealing surface 409
that is designed to seal against the sealing surface (423) of the
tapered flange of the retaining element (422) of the inner housing
(420). As in the embodiment depicted in FIG. 7, the embodiment
depicted in FIG. 8 is tapered so as to allow the inner housing to
be readily assembled with the outer housing (401), e.g., by
application of sufficient pressure to the parts to cause the
pliable, resilient outer housing to expand sufficiently to allow
the inner housing (420) to be inserted into the outer housing's
main cavity (404) to the point where the bearing surface (424) of
the inner housing's retaining element (422) passes beyond the outer
housing's inner housing retaining element (406), at which point the
outer housing (401) contracts and the bearing surfaces (424, 410)
of the inner and outer housings' retaining elements (422, 406) come
into contact so as to prevent the inner housing (420) from being
pulled out of the outer housing's main cavity (404) and to provide
a smooth interface that allows easy, low friction rotation between
the inner and outer housings (420, 401) if and when desired.
[0124] As will be appreciated, and as shown in FIGS. 8C-8E, the
compressible cleansing matrix (405) is inserted into the matrix
well (404) during manufacture. The matrix (405) can be impregnated
with a cleansing reagent (e.g., silver ions), and in preferred
embodiments, a liquid disinfectant such as a 70% IPA solution. The
bearing surface (424) of the outer housing retaining element (422),
here also a tapered flange molded as part of the inner housing
(420) during manufacture, is designed to ride on the complementary
bearing surfaces (410) disposed on the inner surface of the outer
housing's main cavity (404). The inner housing retaining elements
(411) of the outer housing (401) provide for retention of the inner
housing (420) in the outer housing's main cavity (404) after the
inner housing assembled into a functional subassembly with the
outer housing during manufacture. For example, the inner housing
may be urged into the outer housing with sufficient force to join
them into a functional subassembly ready for insertion of
compressible cleansing matrix 405) followed by instillation of a
liquid disinfectant (e.g., a 70% IPA solution), sealing, packaging,
and sterilization. The inner housing engaging elements (411)
present on the inner surface of the outer housing's sidewall (402)
allow the outer housing (401) to engage outer housing engaging
elements (426) on the adjacent outer surface of the inner housing
(420).
[0125] FIG. 8D, the cross section view shows the components of the
device of the invention (outer housing (401), compressible
cleansing matrix (405), and inner housing (420)) assembled into a
functional capping and cleansing device (400) ready for attachment
to the threaded region of the valve portion (105) of the NC
depicted in FIG. 8A. When the device (400) is attached to an NC
(100), the NC contacting surface of the matrix (405) contacts the
valve surface (110) of the NC, allowing that surface to be cleansed
by a user rotating the device (400) in relation to the NC. FIG. 8E
is a cross section showing the capping and cleansing device (400)
of the invention screwed onto the NC, which results compression of
the compressible cleansing matrix (405) against the NC's valve
surface (110).
[0126] FIG. 9 (FIGS. 9A-9E) shows five different views of another
representative capping and cleansing device of the invention. This
embodiment is similar to that depicted in FIG. 8 (FIGS. 8A-8E), the
difference being that in the embodiment shown in FIG. 9 the outer
housing (501) has a different outer configuration than the
embodiment depicted in FIG. 8. Here, the sidewall (502) forming the
structural portion of the device (500) has a step in it, giving it
a layered, "wedding cake" appearance in profile. To make the device
(500) easy for a user to grasp, a series of exterior ribs (535) are
provided on the upper portion of the outer housing's exterior.
[0127] Specifically, FIG. 9 (FIGS. 9A-9E) shows five different
views of another representative capping and cleansing device of the
invention (500) in which a user engages the inner and outer
housings (520, 501) by squeezing (or applying pressure using two or
more fingers) the outer housing (501), causing it to deform
slightly and move inner housing engaging elements (511) present on
the inner surface of the outer housing's sidewall so that one or
more them (typically on opposite sides of the outer housing (501))
engage outer housing engaging elements (526) present on the
exterior surface of the inner housing (520) below the inner housing
retaining element (522) on the outer surface of inner housing's
sidewall (521). The top of the outer housing (509) integrates with
the outer housing's sidewall (502). FIG. 9D shows an exploded
perspective view of the device (outer housing (501), compressible
cleansing matrix (505), and inner housing (520)) and an NC (100) to
which the device (500) is to be connected (see FIGS. 9B, 9C). The
NC (100) has threaded valve region (105) that includes a collar
(101) below its threaded portion (102). The valve surface (110) is
disposed on top of the threaded valve region (105). In FIGS. 9A-9E,
the valve of the NC (100) is not depicted.
[0128] FIG. 9A shows a perspective view of the assembled device
(500) depicted in FIG. 9D secured to the threaded region of the
valve portion (105) of the NC (100) depicted in FIG. 9A.
Preferably, the plastic used to injection mold the outer housing
(501) of the device (500) shown in this embodiment is softer than
the plastic used to mold the inner housing (502). Preferably, the
plastic used to form the outer housing is sufficiently pliable to
allow it to be squeezed by a user to allow engagement of between
the inner and outer housings' engaging elements (526, 511) for
purposes of attaching and removing the device (500) from the NC
(100) but resilient enough to allow the outer housing (501) to
return to its original shape and thus allow the inner and outer
housings' engaging elements (526, 511) to become disengaged. This
allows a user to rotate the outer housing (501) and matrix 505) in
relation to the NC (100) in order to cleanse its valve surface
(110) when a cleansing operation is performed, for example, by
rotating the device (500) without engaging the inner and outer
housings' engaging elements (526, 511) a sufficient period of time
(e.g., 1-15 seconds or more) and/or for a desired amount of
rotation (e.g., 360 to 3,600 or more degrees) in the same or
different directions.
[0129] FIG. 9D shows an exploded cross-section view of the
components depicted in FIGS. 9A-9C. In this embodiment (500), a
tapered, downwardly extending seal element (508) is disposed on the
bottom surface of the component forming the matrix well (503) in
the outer housing (501). This seal (508) has a sealing surface 509
that is designed to seal against the sealing surface (523) of the
tapered flange of the retaining element (522) of the inner housing
(520). As in the embodiments depicted in FIGS. 7 and 8, the
embodiment depicted in FIG. 9 is tapered so as to allow the inner
housing to be readily assembled with the outer housing (501), e.g.,
by application of sufficient pressure to the parts to cause the
pliable, resilient outer housing to expand sufficiently to allow
the inner housing (520) to be inserted into the outer housing's
main cavity (504) to the point where the bearing surface (524) of
the inner housing's retaining element (522) passes beyond the outer
housing's inner housing retaining element (506), at which point the
outer housing (401) contracts and the bearing surfaces (524, 510)
of the inner and outer housings' retaining elements (522, 506) come
into contact so as to prevent the inner housing (520) from being
pulled out of the outer housing's main cavity (504) and to provide
a smooth interface that allows easy, low friction rotation between
the inner and outer housings (520, 501) if and when desired.
[0130] As will be appreciated, and as shown in FIGS. 9B-9E, the
compressible cleansing matrix (505) is inserted into the matrix
well (504) during manufacture. The matrix (505) can be impregnated
with a cleansing reagent (e.g., silver ions), and in preferred
embodiments, a liquid disinfectant such as a 70% IPA solution. The
bearing surface (524) of the outer housing retaining element (522),
here also a tapered flange molded as part of the inner housing
(520) during manufacture, is designed to ride on the complementary
bearing surfaces (510) disposed on the inner surface of the outer
housing's main cavity (504). The inner housing retaining elements
(511) of the outer housing (501) provide for retention of the inner
housing (520) in the outer housing's main cavity (504) after the
inner housing assembled into a functional subassembly with the
outer housing during manufacture. For example, the inner housing
may be urged into the outer housing with sufficient force to join
them into a functional subassembly ready for insertion of
compressible cleansing matrix (505) followed by instillation of a
liquid disinfectant (e.g., a 70% IPA solution), sealing, packaging,
and sterilization. The inner housing engaging elements (511)
present on the inner surface of the outer housing's sidewall (502)
allow the outer housing (501) to engage outer housing engaging
elements (526) on the adjacent outer surface of the inner housing
(520).
[0131] FIG. 9D, the cross section view shows the components of the
device of the invention (outer housing (501), compressible
cleansing matrix (505), and inner housing (520)) assembled into a
functional capping and cleansing device (500) ready for attachment
to the threaded region of the valve portion (105) of the NC. When
the device (500) is attached to an NC (100), the NC contacting
surface of the matrix (505) contacts the valve surface (110) of the
NC, allowing that surface to be cleansed by a user rotating the
device (500) in relation to the NC. FIG. 8E is a cross section
showing the capping and cleansing device (500) of the invention
screwed onto the NC, which results compression of the compressible
cleansing matrix (505) against the NC's valve surface (110).
[0132] FIG. 10 shows three different cut-away views of another
representative capping and cleansing device (600) of the invention
in which the outer housing (601) is pushed upward by the
compressible cleansing matrix (605) when the device (600) is
screwed onto the threaded valve region (105) of a needlefree
connector (100). That upward movement places the outer housing
(601) in a neutral position where the engaging elements (611, 626)
of the outer and inner housings (601, 620) are disengaged, allowing
the outer housing (601) to be rotated in relation to the inner
housing (620). FIGS. 10B and 10C show the device (600) secured to
the threaded region of the valve portion (105) of an NC, while FIG.
10A shows the device (600) disconnected from the NC (100). FIG. 10B
shows the outer housing of the device in a neutral position (the
engaging elements of the inner and outer housings are not engaged),
from which a user could rotate the outer housing (and compressible
cleansing matrix) in relation to the inner housing and NC, to which
the inner housing is secured. As will be appreciated, the
compressible cleansing matrix (605) can serve as a spring or
biasing element that, in the absence of a sufficient counteracting
downward force, pushes the outer housing (601) up in relation to
the inner housing (620), allowing a user to rotate the outer
housing (and compressible cleansing matrix) in relation to the
inner housing (620) and NC if and when desired. Absent such
rotation, while connected to the NC the capping and cleansing
device of the invention (600) serves as a cap to protect the
threaded valve region (105) of the NC from environmental
contamination, including microbial contamination. FIG. 10C depicts
the device (600) when the engaging elements (626, 611) of the inner
and outer housings (620, 601) are engaged, allowing the device to
be screwed onto or off of the NC (100).
[0133] In the embodiment depicted in FIG. 10, the device (600) also
includes a seal (630) disposed on the outer surface of the inner
housing (620). The purpose of this seal is to prevent rapid loss of
liquid cleansing reagents from the device once it has been attached
to an NC, as it is preferred that a device according the invention
be capable of remaining attached to an NC for up to 7 or more
days.
[0134] As will be appreciated, in FIGS. 7-10, the lower surfaces
(340, 440, 540, 640) of sidewall of outer housing (301, 401, 501,
601) are surfaces adapted to receive a lid or seal (not shown) to
seal the interior spaces of the devices (300, 400, 500, 600) from
the external environment. This not only allows retention of
cleansing reagents in the compressible cleansing matrices (320,
420, 520, 620) until the particular is used to cap and/or cleanse a
needlefree connector, but also to maintain the device's
sterility.
[0135] Unless the context clearly requires otherwise, throughout
the description above and the appended claims, the words
"comprise," "comprising," and the like are to be construed in an
inclusive sense as opposed to an exclusive or exhaustive sense;
that is to say, in a sense of "including, but not limited to."
Words using the singular or plural number also include the plural
or singular number, respectively. Additionally, the words "herein,"
"hereunder," "above," "below," and words of similar import refer to
this application as a whole and not to any particular portions of
this application. When the word "or" is used in reference to a list
of two or more items, that word covers all of the following
interpretations of the word: any of the items in the list, all of
the items in the list, and any combination of the items in the
list.
[0136] The foregoing description, for purpose of explanation, has
been described with reference to specific embodiments. However, the
illustrative discussions above are not intended to be exhaustive or
to limit the invention to the precise forms disclosed. Many
modifications and variations are possible in view of the above
descriptions. The embodiments were chosen and described in order to
best explain the principles of the invention and its practical
applications to thereby enable others skilled in the art to best
utilize the invention and various embodiments with various
modifications as are suited to the particular use contemplated. As
such, the invention extends to all functionally equivalent
structures, methods, and uses, such as are within the scope of the
appended claims, and it is intended that the invention be limited
only to the extent required by the applicable rules of law.
* * * * *