U.S. patent application number 14/484708 was filed with the patent office on 2015-01-01 for cleaning device for male end of intraveneous set.
The applicant listed for this patent is Ivera Medical Corporation. Invention is credited to Christine Arme, Paul DiPerna, Gino Kang, Bobby E. Rogers.
Application Number | 20150000061 14/484708 |
Document ID | / |
Family ID | 47554702 |
Filed Date | 2015-01-01 |
United States Patent
Application |
20150000061 |
Kind Code |
A1 |
Rogers; Bobby E. ; et
al. |
January 1, 2015 |
Cleaning Device For Male End Of Intraveneous Set
Abstract
A cleaning device includes a cap having an opening and that
defines an inner cavity, and a channel that extends from a bottom
of the inner cavity to a bottom of the cap. A plunger includes a
domed top surface, a shoulder, and a rod member. The plunger moves
toward the bottom of the cap as the domed top surface is contacted
by a male protrusion of a male medical implement, to push the rod
member and piercing end further into the channel. The crush ribs
contact an inner surface of the channel to inhibit reverse movement
of the plunger. A cleaning material contains a cleaning agent and
is positioned around the rod member and compressed between the
bottom of the inner cavity and the shoulder of the plunger to
release the cleaning agent around the shoulder to contact the male
protrusion.
Inventors: |
Rogers; Bobby E.; (San
Diego, CA) ; DiPerna; Paul; (San Clemente, CA)
; Kang; Gino; (Irvine, CA) ; Arme; Christine;
(Carlsbad, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Ivera Medical Corporation |
San Diego |
CA |
US |
|
|
Family ID: |
47554702 |
Appl. No.: |
14/484708 |
Filed: |
September 12, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
13553627 |
Jul 19, 2012 |
8832894 |
|
|
14484708 |
|
|
|
|
61509460 |
Jul 19, 2011 |
|
|
|
Current U.S.
Class: |
15/104.93 |
Current CPC
Class: |
A61M 5/315 20130101;
A61M 5/32 20130101; A61B 90/70 20160201; B08B 1/001 20130101 |
Class at
Publication: |
15/104.93 |
International
Class: |
A61B 19/00 20060101
A61B019/00; B08B 1/00 20060101 B08B001/00 |
Claims
1. A cleaning device for a male medical implement having a male
protrusion, the cleaning device comprising: a cap that defines an
inner cavity having a top and a bottom, the top of the inner cavity
defining an opening, the cap further defining a channel that
extends from the bottom of the inner cavity to a bottom of the cap,
the channel having a diameter that is smaller than a diameter of
the inner cavity; a plunger in the inner cavity, the plunger
includes a domed top surface, a shoulder below the domed top
surface, and a rod member extending below the shoulder to a
piercing end, the rod member further having a plurality of crush
ribs extending laterally from the rod member, the piercing end of
the plunger extending into the channel such that the domed top
surface and shoulder are positioned proximate the opening, the
plunger being configured to move toward the bottom of the cap as
the domed top surface is contacted by the male protrusion of the
male medical implement, to push the rod member and piercing end
further into the channel, such that the crush ribs contact an inner
surface of the channel to inhibit reverse movement of the plunger;
and a cleaning material around the rod member between the shoulder
and the crush ribs, the cleaning material at least partially
containing a cleaning agent, the cleaning material being compressed
between the bottom of the inner cavity and the shoulder of the
plunger to release the cleaning agent around the shoulder to
contact the male protrusion of the male medical implement.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation and claims benefit of
priority under 35 U.S.C. .sctn.120 of U.S. patent application Ser.
No. 13/553,627, filed Jul. 19, 2012, entitled "Cleaning Device For
Male End Of Intraveneous Set", which claims the benefit of priority
under 35 U.S.C. .sctn.119 of U.S. Provisional Application No.
61/509,460, filed Jul. 19, 2011, entitled "Cleaning Device For Male
End Of Intraveneous Set". These references are incorporated herein
by reference in their entirety for all purposes.
BACKGROUND
[0002] One conventional solution for protection of a male end of an
intravenous (IV) device that is known as a "dual cap". This device
has a cap used to disinfect luer access valves and has a second cap
used to cap the male distal end of an IV. However, there is no
one-to-one ratio of these two caps for a single access line
female-to-male luer interface. Thus, many caps of this set of two
caps will be wasted. Further, there is the issue of throwing away
unused caps and their associated costs and inconvenience. Also,
this system has too many parts, also adding to cost to
manufacture.
SUMMARY
[0003] This document describes a cleaning device implemented as
disinfecting caps. While some caps are designed for attachment to
luer activated needle free valves to disinfect and protect them
from contamination, the present disclosure describes a cap for BR
attachment to the distal tip of an IV set. This distal tip is an
open tab and is normally configured as a male luer lock or male
luer slip. The cleaning device of the present application will
attach to the male distal end of the IV set to disinfect and
protect that tip from contamination. Outside of dimensional
differences, several key features of the cleaning device include:
Threads are located on an outside surface of the cap rather than
inside as with other caps; and a friction based plunger internal to
the cap is configured to act as a seal to prevent the chemical
disinfecting agent from entering into the male distal end of the
set. This plunger may or may not be a true seal, but should inhibit
entrance of the chemical agent into the line.
[0004] Disinfection device for the distal tip of an IV set, in
particular the male distal tip of the IV set, is preferably a
single use disposable product with a removable foil-sealable
opening, either individually sealed or sealed to a strip or plane
of seal material. This device includes an IPA soaked sponge inside,
and is made of materials compatible with IPA. The threading
preferably meets the ISO standard(s) and allows the device to lock
onto the distal male luer. In some implementations, the device is
green in color. When attached to the distal end of an IV set, the
IPA does not enter the fluid line, and can include an internal pin
to seal the orifice. Further, the IV set's distal end and sidewalls
of the male luer nozzle is be bathed in IPA when the cap is applied
onto the luer.
[0005] In one aspect, a cleaning device for a male medical
implement having a male protrusion, the cleaning device includes a
cap that defines an inner cavity having a top and a bottom, the top
of the inner cavity defining an opening. The cap further defines a
channel that extends from the bottom of the inner cavity to a
bottom of the cap, the channel having a diameter that is smaller
than a diameter of the inner cavity. The cleaning device further
includes a plunger in the inner cavity. The plunger includes a
domed top surface, a shoulder below the domed top surface, and a
rod member extending below the shoulder to a piercing end. The rod
member further includes a number of crush ribs extending laterally
from the rod member, the piercing end of the plunger extending into
the channel such that the domed top surface and shoulder are
positioned proximate the opening in an initial position. The
plunger is configured to move toward the bottom of the cap as the
domed top surface is contacted by the male protrusion of the male
medical implement, to push the rod member and piercing end further
into the channel, and such that the crush ribs contact an inner
surface of the channel to inhibit reverse movement of the plunger.
The cleaning device further includes a cleaning material around the
rod member between the shoulder and the crush ribs, the cleaning
material at least partially containing a cleaning agent. The
cleaning material is compressed between the bottom of the inner
cavity and the shoulder of the plunger to release the cleaning
agent around the shoulder to contact the male protrusion of the
male medical implement.
[0006] The details of one or more embodiments are set forth in the
accompanying drawings and the description below. Other features and
advantages will be apparent from the description and drawings, and
from the claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0007] These and other aspects will now be described in detail with
reference to the following drawings.
[0008] FIG. 1 is an isometric view of a cleaning device for a male
leur end of an intravenous (IV) line.
[0009] FIG. 2 is a cut-away view of a housing of the device.
[0010] FIG. 3 is a view of a plunger of the device.
[0011] FIG. 4 is an assembly drawing showing the plunger in foam
before insertion into the housing. Not shown are the seal and
chemical agent.
[0012] FIG. 5 illustrates the male distal tip of an IV set
approaching the opening of a cleaning device.
[0013] FIG. 6 shows the male distal tip in contact with the plunger
of the cleaning device.
[0014] FIG. 7 shows the male distal tip fully inserted into the
housing of the cleaning device.
[0015] FIG. 8 is a cut-away view of an alternative implementation
of a cleaning device.
[0016] FIG. 9 illustrates the male distal tip approaching a
cleaning device.
[0017] FIG. 10 shows the male distal tip in contact with the
plunger of the cleaning device.
[0018] FIG. 11 shows the cleaning device fully engaged with a male
leur end of an IV device.
[0019] FIG. 12 is a top-down view of the cleaning device.
[0020] Like reference symbols in the various drawings indicate like
elements.
DETAILED DESCRIPTION
[0021] This document describes a cleaning device in the form of a
cap to attach to a male distal end of an IV set to disinfect the
male distal end, and to protect that male distal end from
contamination. In accordance with some implementations, a cleaning
device is provided for a male medical implement having a male
protrusion. The cleaning device includes a cap that defines an
inner cavity having a top and a bottom, the top of the inner cavity
defining an opening. The cap further defines a channel that extends
from the bottom of the inner cavity to a bottom of the cap, the
channel having a diameter that is smaller than a diameter of the
inner cavity.
[0022] The cleaning device further includes a plunger in the inner
cavity. The plunger includes a domed top surface, a shoulder below
the domed top surface, and a rod member extending below the
shoulder to a piercing end. The rod member further includes a
number of crush ribs extending laterally from the rod member, the
piercing end of the plunger extending into the channel such that
the domed top surface and shoulder are positioned proximate the
opening in an initial position. The plunger is configured to move
toward the bottom of the cap as the domed top surface is contacted
by the male protrusion of the male medical implement, to push the
rod member and piercing end further into the channel, and such that
the crush ribs contact an inner surface of the channel to inhibit
reverse movement of the plunger.
[0023] The cleaning device further includes a cleaning material
around the rod member between the shoulder and the crush ribs, the
cleaning material at least partially containing a cleaning agent.
The cleaning material is compressed between the bottom of the inner
cavity and the shoulder of the plunger to release the cleaning
agent around the shoulder to contact the male protrusion of the
male medical implement.
[0024] FIGS. 1-7 illustrate preferred exemplary implementations of
a cleaning device for a male leur end of an intravenous (IV) line.
In FIG. 1 an isometric view of a preferred implementation is shown.
The housing (1) is a unitary body. The housing (1) may be
constructed of any material compatible with the cleaning agent that
is kept inside. Examples of materials would include silicone,
rubber, high density polyethylene, polyurethane, etc. The housing
(1) has an opening (5) large enough to allow the insertion of a
medical device. Near the opening (5) are threads (2) that in the
preferred embodiment are luer threads capable of coupling with
other luer threads. As one will note, threads are just one means of
attachment, a friction based attachment can also be used to attach
to the inserted medical device, which in this case is the male
distal end of an IV set or syringe. At the opposing end of opening
(5) is closed end (7). Around the periphery of closed end (7) are
ribs (6) which help facilitate the user's rotation of the housing.
The ribs are which could result in the stripping of threads (2).
Housing (1) with opening (5) and closed end (7) serve to create a
cavity within the housing.
[0025] In FIG. 2 a cross-section of housing (1) is shown. Cavity
(16) and plunger wall (13) are formed by opening (5) and closed-end
(7). Cavity (16) is open at one end (11) and the other end (17) is
closed except where plunger wall (13) begins. Plunger wall (13) is
located in the center of the bottom of cavity (16). Plunger wall
(13) is open into cavity (16) and has a closed-end (14). Plunger
wall (13) is generally cylindrical except it has long channels (12)
along its circumference traveling the length of plunger wall
(13).
[0026] FIG. 3 is a view of the plunger (20). The plunger (20) can
be constructed of the same material as the housing or any
combination. The plunger (20) is comprised of a domed top-surface
(24), a shoulder (21), crush ribs (23) and piercing end (22).
[0027] FIG. 4 illustrates an assembly of the cleaning device. This
illustrates the plunger (20) piercing the compressible material
(30). Piercing is achieved by pushing plunger piercing end (22)
through the compressible material. This new assembly will then be
pushed into housing (1) cavity (16) first through opening (11). The
compressible material can be made to approximate cavity (16)
dimensions. The piercing end (22) then seats itself into plunger
wall (13) see FIG. 5. The foil seal and chemical agent are not
shown.
[0028] The crush ribs (23) of piercing end (22) are slightly larger
than the diameter of plunger wall (13) so that it acts as a brake
on inadvertent movement. FIG. 5 shows a male luer (40) in relation
to the assembled invention. FIG. 6 shows male luer (40) in contact
with plunger (20). An area (24) of the plunger self-centers itself
into the male luer's (40) open lumen (42). The dome (24) acts to
seal or inhibit fluid flow into or out of open lumen (42). The male
luer (40) has dimensions defined by an ISO standard. The wall (41)
of the lumen (42) has a defined outer dimension and taper. The
largest diameter is away from opening (42). The largest diameter of
(41) is slightly smaller than the diameter of cavity (16). This
dimensional difference creates a gap (11) between wall (41) and the
wall of cavity (16). This gap is important because it allows the
chemical agent to "wick" up the walls of (41) to disinfect these
areas and the gap serves as a means to allow venting of extra
pressures created within the housing as the male luer (40) is
inserted. If this venting were not allowed then the chemical agent
when compressed, would need to find escape, in this case it would
be up through (42).
[0029] FIG. 7 shows the male luer (40) fully inserted into the
housing. As the compressible material (30) is compressed it
releases the chemical agent to clean, scrub and disinfect the male
luer (40) and walls (41). As the male luer (40) continues its
travel into the housing, the dome (24) remains seated to seal
opening (42). The ribs (23) continue to act as a braking force to
maintain dome (24) contact with opening (42). The plunger (20) can
only be moved down into plunger wall (13) by the mechanical force
of male luer (40) and its threads (43). Note the gap (11) still
exists. Similarly, the plunger wall (13) must also be vented. As
the plunger (30) moves down into wall (13) the trapped fluids
and/or gases must vent or the unit may not function. Channels (12)
serve that purpose. Attached is a cross-sectioned top view of the
plunger wall FIG. 12. Accordingly, there is no need for biasing the
plunger as with conventional devices.
[0030] FIGS. 8-11 illustrate various alternative implementations of
a cleaning device. The main difference is in the plunger wall
design. In FIG. 8, one can see the plunger wall is defined by two
or more splines (50). As seen in FIG. 11, these splines hold the
plunger assembly in place and splay outward to provide the braking
force.
[0031] In the implementations described herein, chemical agents
that could be used include, but not be limited to, isopropyl
alcohol, chlorhexidone gluconate, chlorhexidone diacitate,
povidone-iodine, ethanol, etc.
[0032] The lid (not shown), can be made from foil laminates or even
non-paper materials that could be easily broken away to allow
access. In preferred implementations, the lid is thermally or
electrothermally bonded to or near the opening of the cap, and can
be peeled away for cleaning the IV device. A lid in the
configuration of a strip or planar piece of material could be
configured to allow multiple devices to be placed on it, to allow
each cap to be pulled away and used independently and separately.
Alternatively, each cleaning device could be sealed and used on
individual basis.
[0033] Although a few embodiments have been described in detail
above, other modifications are possible. Other embodiments may be
within the scope of the following claims.
* * * * *