U.S. patent application number 16/995104 was filed with the patent office on 2020-12-03 for isolator sleeve systems.
The applicant listed for this patent is CLEAN AIR ESSENTIALS 797 INC.. Invention is credited to Magdi MOUSSA, Daniel ZINI.
Application Number | 20200375265 16/995104 |
Document ID | / |
Family ID | 1000005021466 |
Filed Date | 2020-12-03 |
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United States Patent
Application |
20200375265 |
Kind Code |
A1 |
MOUSSA; Magdi ; et
al. |
December 3, 2020 |
ISOLATOR SLEEVE SYSTEMS
Abstract
A cuff attachment for an isolator sleeve cuff, the cuff
attachment comprising an annular band of substantially elastomeric
material having an open first end and an open second end, the first
end having a diameter which is wider than a diameter of the second
end, the first end being adapted to be attachable to an isolator
sleeve cuff, and the second end being adapted to releasably retain
a plug therein. A plug for sealing the second end of the cuff
attachment, the plug comprising a body sized and shaped to be
releasably retained in the second end of the cuff attachment. An
isolator sleeve system comprising the cuff attachment and the
plug.
Inventors: |
MOUSSA; Magdi; (Montreal,
CA) ; ZINI; Daniel; (Montreal, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
CLEAN AIR ESSENTIALS 797 INC. |
Montreal |
|
CA |
|
|
Family ID: |
1000005021466 |
Appl. No.: |
16/995104 |
Filed: |
August 17, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15576790 |
Nov 24, 2017 |
10743590 |
|
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PCT/CA2016/051387 |
Nov 25, 2016 |
|
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16995104 |
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62261411 |
Dec 1, 2015 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 42/50 20160201;
A61G 10/005 20130101; G21F 7/053 20130101; A41B 7/12 20130101; B25J
21/02 20130101; A61B 42/00 20160201 |
International
Class: |
A41B 7/12 20060101
A41B007/12; A61B 42/00 20060101 A61B042/00; B25J 21/02 20060101
B25J021/02; G21F 7/053 20060101 G21F007/053; A61B 42/50 20060101
A61B042/50 |
Claims
1. A plug for sealing an end of a cuff portion of an isolator
sleeve, the plug comprising a body having a front end and a back
end, the front end having a front face which is convex, the back
end having a handle extending from the back face; and an annular
groove extending around the body for receiving the end of the cuff
portion during retention of the plug in the end of the cuff portion
of the isolator sleeve.
2. The plug of claim 1, wherein the body has a larger diameter at
the back end than the front end.
3. The plug of claim 1, wherein the plug has a one-piece
construction.
4. The plug of claim 1, wherein the back end has a back face which
is concave.
5. The plug of claim 1, wherein the handle has a stem portion and a
grip portion, the grip portion being wider than the stem
portion.
6. The plug of claim 5, wherein an end of the grip portion has
shoulders and an indent.
7. The plug of claim 1, wherein the annular groove is positioned
closer to the front end than the back end.
8. The plug of claim 1, wherein the annular groove is positioned
about midway between the front end and the back end.
9. The plug of claim 1, wherein a thickness of the body from the
annular groove to the front end is less than a thickness of the
body from the annular groove to the back end.
10. The plug of claim 1, further comprising the cuff portion of the
isolator sleeve, the cuff portion comprising an annular band of
substantially elastomeric material having an open first end and an
open second end, the first end being configured to be detachably
attachable to the isolator sleeve and having a diameter which is
wider than a diameter of the second end of the cuff portion, and
the second end being adapted to releasably retain the plug
therein.
11. The plug of claim 10, wherein the second end of the cuff
portion is adapted to stretch to allow the plug to pass
therethrough, in use, and to form a seal around the plug when the
plug is retained in the second end, in use.
12. The plug of claim 10, wherein the diameter of the second end of
the cuff portion is less than a diameter of the plug, when the
second end is in a non-stretched state.
13. The plug of claim 10, wherein the first end of the cuff portion
comprises a reinforced rim portion.
14. The plug of claim 13, wherein the reinforced rim portion
comprises a thicker annular portion of the substantially
elastomeric material.
15. The plug of claim 13, wherein the reinforced rim portion is
sized and shaped to be engaged in the annular groove of the
plug.
16. The plug of claim 10, wherein the cuff portion is a truncated
cone shape.
17. A system for sealing an end of an isolator sleeve, the system
comprising: a cuff portion comprising an annular band of
substantially elastomeric material having a first end configured to
be detachably attachable to the isolator sleeve, and a second end
configured to releasably retain a plug therein to seal the second
end in use; and a plug comprising a body having a front end and a
back end, the front end having a front face which is convex, the
back end having a handle extending from the back face; and an
annular groove extending around the body for receiving the second
end of the cuff portion during retention of the plug in use.
18. The system of claim 17, wherein the first end of the cuff
portion comprises a reinforced rim portion which is sized and
shaped to be engaged in the annular groove of the plug.
19. The system of claim 17, wherein the annular groove of the plug
is positioned closer to the front end than the back end.
20. The system of claim 1, wherein a diameter of the first end of
the cuff portion is less than diameter of the back end of the plug.
Description
CROSS-REFERENCE
[0001] The present application claims convention priority to U.S.
Provisional Patent Application No. 62/261,411, filed Dec. 1, 2015,
entitled "ISOLATOR SLEEVE SYSTEMS" which is incorporated by
reference herein in its entirety.
FIELD OF THE DISCLOSURE
[0002] The present disclosure relates to isolator sleeve systems,
and more specifically although not exclusively, to isolator sleeve
systems relating to a cuff portion of an isolator sleeve.
BACKGROUND OF THE DISCLOSURE
[0003] Isolators typically comprise enclosures for isolating an
inside workspace from an outside environment, thus providing a
barrier for contaminants entering the inside workspace and/or for
contaminants leaving the workspace and causing potential harm.
Examples of isolators include, but are not limited to, restricted
access barrier systems (RABS), closed RABS, compounding aseptic
isolators, compounding aseptic containment isolators, and
gloveboxes. Isolators are useful in the pharmaceutical, medical,
chemical, and electrical engineering industries, such as in the
manufacture or compounding of drugs in hospitals or pharmacies,
handling radioactive and other dangerous materials, and
manufacturing electronic components, to name a few.
[0004] In a typical isolator system, openings such as arm ports are
provided on a front face of the isolator for allowing the hands and
arms of a user to access the inside workspace. Sleeves are provided
which are attachable to the arm ports and which extend into the
workspace. Gloves are sealingly attachable to a distal end of the
sleeve typically using a sleeve cuff such as a rigid ring with
annular grooves. In use, a user puts his or her arms through the
arm ports and into the sleeves wearing a pair of inner disposable
gloves. Once the user's arms, covered by the sleeves, are in the
workspace within the isolator, the user can wipe the inner gloves
with a sterilizing agent, such as isopropyl alcohol, place an outer
pair of sterile gloves on the inner gloves, and attach the outer
gloves to the sleeve cuff to thereby isolate the user from the
inside workspace. Typically, the outer gloves are attached to the
sleeve by stretching a cuff end of the outer gloves over the sleeve
cuff and securing in place with a resilient ring such as a rubber
`o` ring received in one of the annular groves of the sleeve
cuff.
[0005] In certain isolator uses, such as pharmaceutical
compounding, regulations require frequent sterile glove changes
whilst performing the compounding inside the isolator. This can be
time consuming and awkward for the user and can sometimes result in
tears to the new outer glove which can slow the glove change
process down even further and risk contamination to the user and
the isolator workspace.
[0006] The glove change process, for each hand, typically comprises
removal of the resilient ring holding the outer glove to the sleeve
cuff, removal of the outer glove from the user's hand, attachment
of a new outer glove to the sleeve cuff and placement of the
resilient ring around the new outer glove on the sleeve cuff. In
some cases, the sleeve may be pulled out of the inside workspace,
whilst still attached to the isolator at the port end, and the
glove change performed exteriorly of the isolator. In other cases,
the glove change may be performed inside the isolator workspace but
the used outer glove removed through the sleeve and disposed of
outside of the isolator. It will be appreciated that such glove
changes of isolator systems of the prior art are awkward as single
handed manipulation by the user is required and also there is a
risk of breaching the inside workspace environment and subsequent
contamination of the user or the outside environment by hazardous
compounds.
[0007] Furthermore, inbetween work sessions at the isolator or when
switching between users, a new outer glove is typically left
attached to the sleeve in order to maintain the inside work
environment inside the isolator. However, if the next user requires
a different size of outer glove, this will necessitate a further
glove change, taking up time and having the associated awkwardness
and environmental breach risk mentioned above.
[0008] Therefore, there is a need for isolator sleeve systems which
overcome or reduce at least some of the above-described
problems.
SUMMARY OF THE DISCLOSURE
[0009] Broadly, there is provided an isolator sleeve system
comprising a cuff attachment for use with an isolator sleeve cuff.
The isolator sleeve system may also comprise a plug for sealing the
cuff attachment, the isolator sleeve cuff and/or an isolator
sleeve.
[0010] From one aspect, there is provided a cuff attachment for an
isolator sleeve cuff, the cuff attachment comprising an annular
band of substantially elastomeric material having an open first end
and an open second end, the first end having a diameter which is
wider than a diameter of the second end, the first end being
adapted to be attachable to an isolator sleeve cuff and the second
end being adapted to releasably retain a plug therein. The second
end is preferably sized and shaped to allow a hand of a user to
pass therethrough.
[0011] In certain embodiments, the second end is adapted to stretch
to allow the plug to pass therethrough, in use. In certain
embodiments, the second end is arranged to allow the plug to pass
through the opening at the second end in both directions, i.e., in
the direction of the first to second end, and in the direction of
the second end to the first end. In certain embodiments, the second
end is arranged to form a seal around the plug when the plug is
retained in the second end, in use. The seal may be a fluid seal
e.g. an air-tight seal and/or a liquid seal. In certain
embodiments, the diameter of the second end is less than a diameter
of the plug, when the second end is in a non-stretched state. The
substantially elastomeric material of the cuff attachment may
stretch to allow the plug to pass therethrough, then substantially
recover once the stretching force is reduced or removed to form the
seal around the plug.
[0012] In certain embodiments, the second end is adapted to stretch
to allow a hand of a user to pass therethrough. In certain
embodiments, the diameter of the second end is less than a diameter
of the wrist of the user's hand, when the second end is in a
non-stretched state. The second end may be arranged to form a seal
around a wrist of the user's hand, or around any other part of the
user's hand when the hand is passed through the second end from the
first end. The seal may be a fluid seal e.g. an air-tight seal
and/or a liquid seal. The substantially elastomeric material of the
cuff attachment may stretch to allow the user's hand to pass
therethrough, then substantially recover or relax when a stretching
force is reduced or removed to form the seal around the user's hand
or wrist.
[0013] In certain embodiments, the first end of the cuff attachment
is arranged to form a seal around the isolator sleeve cuff, in use.
The seal may be a fluid-tight seal, e.g. an air-tight and/or a
liquid-tight seal. The first end may have a rim portion defining an
opening at the first end, the opening being sized and shaped to
encircle the isolator sleeve cuff when the rim portion of the first
end is stretched and placed around the isolator sleeve cuff in
use.
[0014] In certain embodiments, the first end may comprise a
reinforced rim portion. The reinforced rim portion may define an
opening at the first end. The opening may be sized and shaped to
encircle or snap-fit around the isolator sleeve cuff when the
reinforced rim portion of the first end is stretched and placed
around the isolator sleeve cuff in use. The reinforced rim portion
may comprise a thicker annular portion of the substantially
elastomeric material. Alternatively, the reinforced rim portion may
comprise an additional layer of material. The reinforced rim
portion may require more force to stretch it compared to the force
required to stretch the second end of the cuff attachment by an
equivalent amount.
[0015] In certain embodiments, the diameter of the first end of the
cuff attachment is less than a diameter of the isolator sleeve
cuff, when the first end of the cuff attachment is in a
non-stretched state. The substantially elastomeric material of the
cuff attachment at the first end may stretch to allow the first end
to be retained around the isolator sleeve cuff, then substantially
recover or relax to form the seal around the isolator sleeve cuff
when the stretching force is reduced or removed. In certain
embodiments, the first end of the cuff attachment is arranged to
form a snap-fit around the isolator sleeve cuff, in use. In these
embodiments, additional means such as resilient rings (e.g.
o-rings) or clamps for attaching the cuff attachment to the
isolator sleeve cuff are not required. In use, at least a portion
of the first end of the cuff attachment overlaps a portion of the
isolator sleeve cuff.
[0016] In certain embodiments, the reinforced rim portion is sized
and shaped to be engaged in an annular groove of the isolator
sleeve cuff. The reinforced rim portion may have a width which is
equal to or less than a width of the annular groove in the isolator
sleeve cuff. The reinforced rim portion may have a thickness which
is equal to or less than a height of the annular groove in the
isolator sleeve cuff. In certain embodiments, this may assist in
the retention of the cuff attachment on the isolator sleeve cuff,
particularly during use. The isolator sleeve cuff may be of any
suitable design and made of any suitable material. Advantageously,
certain embodiments of the present cuff attachment can be
retroactively attached to many types of isolator sleeve cuffs.
[0017] In certain embodiments, the substantially elastomeric
material can be any material which has properties allowing
stretching on application of a force and substantial or adequate
recovery when the force is removed. In certain embodiments, the
substantially elastomeric material is a sterilizable material. In
certain embodiments, the substantially elastomeric material is a
silicone, such as silicone rubber. The silicone may be a
medical-use grade silicone, such as FDA approved medical use grade
silicone. Alternatively, any other substantially elastomeric
material may be used such as but not limited to polysiloxane,
natural rubber, or other synthetic rubber.
[0018] In certain embodiments, the cuff attachment is a truncated
cone shape. In certain embodiments, the first and/or second ends
are circular.
[0019] In certain embodiments, the cuff attachment includes the
plug and/or the isolator sleeve cuff and/or an isolator sleeve.
[0020] In certain embodiments, the plug comprises a body sized and
shaped to be releasably retained in the second end of the cuff
attachment. In certain embodiments, the plug comprises a body sized
and shaped to be engaged with the second end of the cuff
attachment. In certain embodiments, the plug comprises a body sized
and shaped to enable the plug to pass through the second end when
the second end is stretched.
[0021] In certain embodiments, the plug has an annular groove
around the body for receiving the second end of the cuff member.
The annular groove has a depth sufficient to allow retention of the
second end of the cuff attachment in the annular groove. In certain
embodiments, the plug has a bead or a lip against which the second
end of the cuff member can abut in use.
[0022] In certain embodiments, the plug has a front face which is
substantially convex. In certain embodiments, the plug has a front
face which is substantially rounded. In certain embodiments, the
plug has a front face which is substantially pointed. In certain
embodiments, the plug has a substantially smooth surface. In
certain embodiments, some or all of these features may facilitate
movement of the plug through the second end of the cuff attachment.
In certain embodiments, the back face of the plug body may be
concave to reduce the amount of material used to make the plug.
[0023] In certain embodiments, the plug comprises a handle
extending from the back face of the body. The handle is arranged to
allow a user to grip the plug for pulling or pushing the plug
through the second end of the cuff attachment. The handle may have
a stem portion and a grip portion. The grip portion may be wider
than the stem portion, and may have an indent to allow a user's
thumb to rest thereon. The grip portion may have shoulders for
allowing a user's fingers to rest thereon.
[0024] In certain embodiments, the annular groove may be positioned
closer to the front end than the back end of the body of the plug.
Alternatively, the annular groove can be positioned about mid-way
from the front face to the back face. The body of the plug may have
a larger diameter at the back end than the front end.
[0025] In certain embodiments, the plug may be made of any suitable
material which can be sterilized, and which is more rigid than the
cuff attachment. In certain embodiments, the plug is made of a
polymer, such as polypropylene or polyethylene. In certain
embodiments, the plug is made of a rigid polymer. In certain
embodiments, the plug is of a one-piece design.
[0026] In certain embodiments, the isolator sleeve may comprise an
elongate tube of material sized and shaped to accommodate the arm
of a user therein. In certain embodiments, the isolator sleeve is
made from a flexible material and which can provide a barrier to
contaminant flow therethrough. In certain embodiments, the isolator
sleeve is made from a material which can be sterilized, such as a
polymer. In certain embodiments, the isolator sleeve is made from
poly vinyl chloride (PVC). In certain embodiments, the isolator
sleeve is free from phthalates, lead and/or metal.
[0027] In certain embodiments, the isolator sleeve cuff comprises a
ring sized and shaped to be attachable to an isolator sleeve at one
end, and to the cuff attachment at the other end. The isolator
sleeve cuff may have a first end arranged to releasably attach to
the sleeve, and a second arranged to releasably attach to the cuff
attachment. In certain embodiments, the isolator sleeve cuff has an
annular groove arranged to retain the first end of the cuff
attachment in use. In certain embodiments, the isolator sleeve cuff
is more rigid than the isolator sleeve material or the cuff
attachment. In certain embodiments, the isolator sleeve cuff
comprises a material which can be sterilized. In certain
embodiments, the isolator sleeve cuff is made from a polymer, such
as but not limited to acrylonitrile butadiene styrene.
[0028] From another aspect, there is provided an isolator sleeve
system comprising a cuff attachment according to certain
embodiments described above for use with an isolator sleeve or an
isolator sleeve cuff, and a plug according to certain embodiments
described above, and optionally an isolator sleeve and/or an
isolator sleeve cuff as described above. In embodiments, where the
isolator sleeve system comprises the cuff attachment and the plug,
these may be used with isolator sleeves and isolator sleeve cuffs
of the prior art. In certain embodiments of the isolator sleeve
system, the cuff attachment and isolator sleeve may be
one-piece.
[0029] From another aspect, there is provided a plug for sealing or
closing an open end of a cuff attachment for an isolator sleeve
cuff. In certain embodiments, the plug and/or the cuff attachment
are as described above.
[0030] In use, in certain embodiments, the first end of the cuff
attachment is attached to the isolator sleeve which may be
extending from a wall of the isolator into a working space of the
isolator; and the plug is sealingly retained in the second end of
the cuff attachment, thereby sealing an environment of the working
space of the isolator, which may be aseptic. Preferably, the plug
is positioned with the front end of the plug pointing away from the
first end of the cuff attachment, and the plug handle pointing
towards the cuff attachment first end. When a user desires to
access the working space inside the isolator, the user's hand is
inserted into the isolator sleeve in normal fashion, and the plug
handle is gripped by the user to push the plug out of the cuff
attachment and into the working space of the isolator. The user's
hand is passed through the second end of the cuff attachment from
the sleeve to access the working space inside the isolator. The
sealed environment of the working space of the isolator may be
substantially maintained in certain embodiments as the second end
of the cuff attachment sealingly engages with the user's hand
and/or wrist as the plug is pushed out of the second end and the
user's hand is pushed through the second end. In certain
embodiments, the user's hand is protected by an inner glove when
the hand is pushed through the second end. In certain embodiments,
an outer glove may be placed on the inner glove on the user's hand.
The outer glove may be a sterile glove and may be placed over the
inner glove after wiping the inner glove with a sterilizing
solution, such as but not limited to an alcohol such as isopropyl
alcohol.
[0031] In certain embodiments, a glove change within the working
space of the isolator can be effected by removing the outer glove
from the hand in the isolator, discarding the removed outer glove
and donning a new outer glove on the hand. In certain embodiments,
this occurs while the environment of the working space remains
substantially intact by virtue of the sealing engagement between
the cuff attachment second end and the user's wrist and/or hand,
and between the first end of the cuff attachment and the isolator
sleeve cuff. Advantageously, in certain embodiments, the glove
change does not require manipulation of resilient rings, such as
`o` rings, or other attachment means, to remove and attach a new
outer glove. Therefore, a glove change using certain embodiments of
the present cuff attachment may be faster than those of the prior
art.
[0032] In certain embodiments, a retreat of the user from the
isolator comprises the user holding the plug by the handle, and
withdrawing his or her hand through the second end of the
attachment in order to replace the sealing engagement of the second
end of the cuff attachment with the user's wrist and/or hand with
the sealing engagement of the second end of the cuff attachment
with the plug. In certain embodiments, the plug may be sterilized
before being retained in the second end such as by wiping with a
sterilizing liquid such as an alcohol.
[0033] Embodiments of the presently described cuff attachment,
plug, system and method, may facilitate glove changes within the
isolator, and avoid glove changes between users of the same
isolator especially when the users require different glove sizes.
Furthermore, this arrangement may help to substantially maintain a
sealed environment of the isolator during glove changes as well as
between users of the isolator, and to help minimize contamination
leakage into or out of the isolator.
Definitions
[0034] It must be noted that, as used in this specification and the
appended claims, the singular form "a", "an" and "the" include
plural referents unless the context clearly dictates otherwise.
[0035] As used herein, the term "about" in the context of a given
value or range refers to a value or range that is within 20%,
preferably within 10%, and more preferably within 5% of the given
value or range.
[0036] As used herein, the term "and/or" is to be taken as specific
disclosure of each of the two specified features or components with
or without the other. For example "A and/or B" is to be taken as
specific disclosure of each of (i) A, (ii) B and (iii) A and B,
just as if each is set out individually herein.
[0037] As used herein, the term "isolator" is intended to mean any
device or apparatus providing an enclosed workspace which is
isolated from the outside environment exterior to the enclosure.
The isolator may provide a barrier for contaminants entering the
workspace e.g. for ensuring the integrity of sterile products
therein, and/or a barrier for contaminants leaving the workspace
e.g. for ensuring safety of at least one user outside of the
isolator. Examples of isolators include, but are not limited to,
restricted access barrier systems (RABS), closed RABS, barrier
technology, and gloveboxes.
[0038] As used herein, the term "isolator sleeve cuff" is intended
to mean a distal end (i.e. a cuff-end) of a sleeve suitable for use
with an isolator. The isolator sleeve cuff may be integral with the
sleeve or may be an appendage attachable to the cuff-end of the
sleeve. One example of a sleeve cuff is a ring with annular grooves
which can be attached to the cuff end of a sleeve at one open end
and can be attached to a glove at the other open end.
BRIEF DESCRIPTION OF DRAWINGS
[0039] Further aspects and advantages of the present invention will
become better understood with reference to the description in
association with the following in which:
[0040] FIG. 1 illustrates a perspective view of one embodiment of a
cuff attachment of the present disclosure;
[0041] FIGS. 2a and 2b illustrate a perspective view and a side
view, respectively, of one embodiment of a plug of the present
disclosure;
[0042] FIG. 3 illustrates the plug of FIGS. 2a and 2b attached to
the cuff attachment of FIG. 1, in use, according to one embodiment
of a system of the present disclosure;
[0043] FIG. 4 illustrates the cuff attachment of FIG. 1 attached to
a sleeve cuff, in use, according to one embodiment of a system of
the present disclosure;
[0044] FIGS. 5a and 5b illustrate an expanded and collapsed view,
respectively, of the cuff attachment of FIG. 1, the plug of FIG. 2,
the sleeve cuff of FIG. 3, and an o-ring according to one
embodiment of a system of the present disclosure; and
[0045] FIGS. 6a and 6b illustrate an expanded and collapsed view,
respectively, of the system of FIGS. 5a and 5b and an isolator
sleeve, according to one embodiment of a system of the present
disclosure.
DETAILED DESCRIPTION
[0046] The present disclosure is not limited in its application to
the details of construction and the arrangement of components set
forth in the following description or illustrated in the drawings.
The disclosure is capable of other embodiments and of being
practiced or of being carried out in various ways. Also, the
phraseology and terminology used herein is for the purpose of
description and should not be regarded as limiting. The use of
"including", "comprising", or "having", "containing", "involving"
and variations thereof herein, is meant to encompass the items
listed thereafter as well as, optionally, additional items. In the
following description, the same numerical references refer to
similar elements.
[0047] Broadly, there is provided a cuff attachment 10 arranged to
sealingly engage at one end with an isolator sleeve cuff; and at
the other end either with a user's hand and/or wrist during the
user working in the isolator, or a plug when there is no user work
being performed in the isolator.
[0048] Referring to FIG. 1, there is illustrated one embodiment of
the cuff attachment 10 of the present disclosure. The cuff
attachment 10 comprises an annular band 12 of substantially
elastomeric material having a truncated cone shape with a first end
14 and a second end 16, the first and second ends 14, 16 being open
and substantially circular, and the diameter of the first end 14
being larger than a diameter of the second end 16. The cuff
attachment is sheath-like and flexible. As can best be seen in FIG.
4, the first end 14 of the cuff attachment 10 is arranged to be
detachably attachable to an isolator sleeve cuff 18. As best seen
in FIG. 3, the second end 16 of the cuff attachment 10 is arranged
to releasably retain a plug therein, such as the plug 20 shown in
FIGS. 2a, 2b and 3. In this embodiment, the substantially
elastomeric material of the cuff attachment 10 is silicone rubber,
such as FDA approved medical-grade silicone rubber, although any
other suitable substantially elastomeric material may be used.
[0049] The first end 14 of the cuff attachment 10 is arranged to
sealingly engage with the isolator sleeve cuff 18 to form a seal
with the isolator sleeve cuff, when attached in use. In this
embodiment, the first end 14 has a diameter less than a diameter of
the isolator sleeve cuff 18, when the first end 14 is in a
non-stretched state. The cuff attachment 10 is arranged to stretch
when a force is applied so that the first end 14 can be stretched
over the isolator sleeve cuff 18, and once the force is removed,
the cuff attachment 10 at least partially recovers towards its
unstretched state to form a snap-fit around the isolator sleeve
cuff 18. The cuff attachment 10 can be removed from the isolator
sleeve cuff 18 by stretching the first end 14 away from the
isolator sleeve cuff 18.
[0050] The first end 14 of the cuff attachment 10 has a reinforced
rim portion 22 which is sized and shaped to engage with an annular
groove 24 on an outer surface of the isolator sleeve cuff 18 (FIG.
5a). Specifically, as seen best in FIG. 4, the reinforced rim
portion 22 has a width which is narrower than a width of the
annular groove 24 so that the reinforced rim portion 22 is received
within the annular groove 24. The reinforced rim portion 22
comprises a thicker annular portion of the substantially
elastomeric material. Alternatively, the reinforced rim portion may
comprise an additional layer(s) of other material, or may comprise
a rolled up or otherwise multi-layered portion of the annular band
to form the thicker annular portion. Alternatively, the reinforced
rim portion may comprise any other configuration which increases
the amount of force required to stretch the first end compared to a
non-reinforced portion of the annular body. The reinforced rim
portion 22 may help retention of the first end 14 of the cuff
attachment 10 on the isolator sleeve cuff 18, during use, without
necessitating the use of securing devices to secure the cuff
attachment 10 to the isolator sleeve cuff 18, such as o-rings and
clamps. In other embodiments (not shown), instead of or in addition
to the reinforced rim portion, there may be provided securing
devices such as o-rings 27 and/or clamps, or any other means of
securing the cuff attachment 10 to the isolator sleeve cuff 18.
[0051] Turning now to FIGS. 6a and 6b, the isolator sleeve cuff 18
is also arranged to sealingly engage with an isolator sleeve 26
(FIGS. 6a and 6b). The attachment of the isolator sleeve cuff 18 to
the isolator sleeve 26 may be in any manner and using any suitable
fastening mechanism. For example, the isolator sleeve cuff 18 may
include windings on an inner surface (not shown) for engagement
with windings on a distal end of the sleeve 26 (not shown).
Alternatively, a resilient ring such as an `o` ring (not shown) may
be used over the isolator sleeve 26 positioned on the isolator
sleeve cuff 18. Alternatively, clamps or other attachment means may
be used to secure the sleeve 26 to the sleeve cuff 18. In this
embodiment, the isolator sleeve cuff 18 is made of a rigid material
such as a polymer e.g. acrylonitrile butadiene styrene, although
any other suitable material may be used.
[0052] It will be appreciated that use of the cuff attachment 10 is
not limited to the isolator sleeve cuff 18 illustrated in FIGS. 4-6
but can be used, such as retroactively, with any suitable isolator
sleeve cuff. For example, instead of an annular groove, the cuff
attachment may include an annular bead or lip on its outer surface
for engagement with the cuff attachment 10. In other embodiments,
the isolator sleeve cuff may be integral with an isolator
sleeve.
[0053] Turning now to the second end 16 of the cuff attachment 10,
the second end 16 is configured to retain the plug 20 in sealing
engagement, such as when it is desired to seal the second end 16 in
use. The second end 16 is also configured to allow the plug 20 to
pass therethrough, when a force is applied in use. The second end
16 is also configured to allow a hand of a user (not shown) to pass
therethrough, when a force is applied, yet to form a seal around a
wrist of the user's hand, when the hand is retained in the second
end 16. In this respect, a diameter of the second end 16 is less
than a diameter of the plug 20 and a diameter of a user's wrist,
when the second end is in a non-stretched state.
[0054] Turning now to the plug 20 with reference to FIGS. 2a and
2b, it can be seen that the plug 20 comprises a body sized and
shaped to be releasably retained in the second end 16 of the cuff
attachment 10, as well as to be able to pass through the second end
16 when a force is applied. More specifically, the plug 20 has a
front face 28 at a front end which is substantially convex or
rounded and a handle 30 extending from a back face 32 at a back end
of the body. The back end of the plug body is concave (not shown)
to reduce the amount of material used to make the plug 20. In
certain embodiments, the body of the plug 20 has a substantially
smooth surface and a slightly larger diameter at the back end than
at the front end which may help to push the plug through the second
end 14 of the cuff attachment 10. The plug 20 has an annular groove
34 around the body in which the second end 14 of the cuff
attachment 10 is received during retention of the plug 10 in the
second end 14. In certain embodiments, the annular groove 34 may be
positioned closer to the front end than the back end of the body of
the plug 20. Alternatively, the annular groove 34 can be positioned
about mid-way from the front face to the back face.
[0055] The handle 30 is arranged to allow a user to grip the plug
20 for pulling or pushing the plug 20 through the second end 14 of
the cuff attachment 10. The handle 30 has a stem portion 36 and a
grip portion 38, the grip portion 38 being wider than the stem
portion 36, and having an indent 40 to allow a user's thumb to rest
thereon. The grip portion 38 has shoulders for allowing a user's
fingers to rest thereon.
[0056] The plug 20 is made of any suitable material which can be
sterilized, and which is more rigid than the cuff attachment 10. In
this embodiment, the plug 20 is made of polypropylene and is of a
one-piece design. However, the plug may be made of any other
polymer and/or may have a multi component design.
[0057] Turning now to the isolator sleeve 26 (FIG. 6), in this
embodiment the isolator sleeve 26 comprises an elongate tube of
material sized and shaped to accommodate the arm of a user therein.
The isolator sleeve 26 is made from a flexible material and which
can provide a barrier to contaminant flow therethrough, such as
poly vinyl chloride (PVC), or any other suitable material. The
isolator sleeve is free from phthalates, lead and/or metal in this
embodiment.
[0058] In use, the first end 14 of the cuff attachment 10 is
attached to the isolator sleeve 26 which is attached to the
isolator (not shown); and the plug 20 is sealingly retained in the
second end 16 of the cuff attachment 10, thereby sealing an
environment of the working space of the isolator, which may be
aseptic. The plug 20 is positioned with the front end of the plug
20 pointing away from the first end 14 of the cuff attachment 10,
and the plug handle 30 pointing towards the cuff attachment first
end 14. When a user desires to access the working space inside the
isolator, the user's hand is inserted into the isolator sleeve 26
in normal fashion, and the plug handle 30 is gripped by the user to
push the plug 20 out of the cuff attachment 10 and into the working
space of the isolator. The user's hand is passed through the second
end 14 of the cuff attachment 10 from the sleeve 26 to access the
working space inside the isolator. The sealed environment of the
working space of the isolator may be substantially maintained in
certain embodiments as the second end 14 of the cuff attachment 10
sealingly engages with the user's hand and/or wrist as the hand is
pushed through the second end 14. The user's hand is protected by
an inner glove when the hand is pushed through the second end 14,
and an outer glove is placed over the inner glove after the hand
has been pushed through the cuff attachment 10 and the inner glove
cleaned with a sterilizing solution such as an alcohol.
[0059] In pharmacy compounding, particularly for chemotherapy drugs
for example, outer gloves (i.e. the gloves that come into contact
with the drug) must be changed every 30 minutes for protection of
the user in case of drug penetration through the gloves. In this
embodiment, an outer glove is changed within the working space of
the isolator by removing the outer glove from the hand in the
isolator, discarding the removed outer glove and placing a new
outer glove on the inner glove. In certain embodiments, this occurs
while the environment of the working space remains substantially
intact by virtue of the sealing engagement between the cuff
attachment 10 second end 16 and the user's wrist and/or hand, and
between the first end 14 of the cuff attachment 10 and the isolator
sleeve cuff 18. Advantageously, in certain embodiments, the glove
change does not require manipulation of resilient rings, such as
`o` rings, or other attachment means, to remove and attach a new
outer glove. Therefore, a glove change using certain embodiments of
the present cuff attachment may be faster than those of the prior
art.
[0060] A retreat of the user from the isolator, for example to
allow another user to work in the isolator, comprises the user
holding the plug 20 by the handle 30, and withdrawing his or her
hand through the second end 16 of the cuff attachment 10 in order
to replace the sealing engagement of the second end 16 of the cuff
attachment 10 with the user's wrist and/or hand with the sealing
engagement of the second end 16 of the cuff attachment 10 with the
plug 20. The plug is preferably wiped with a sterilizing liquid
such as alcohol before being retained in the cuff attachment 10. In
this way, the isolator environment may be maintained whilst the
isolator is not in use. Also when a new user comes to the isolator,
he or she inserts their arm in through the isolator sleeve and
replaces the plug with their hand and/or wrist and starts work in
the isolator after donning a pair of new and clean outer gloves. An
outer glove change is not necessary.
[0061] There is also provided an isolator sleeve system 50, which
according to the embodiment of FIG. 3, comprises the cuff
attachment 10 and the plug 20.
[0062] The isolator sleeve system 50 of FIGS. 5a and 5b differs
from that of FIG. 3, in that the isolator sleeve system 50
additionally includes the isolator sleeve cuff 18.
[0063] The isolator sleeve system of FIGS. 6a and 6b differs from
that of 5a and 5b in that the isolator sleeve system 50
additionally includes the isolator sleeve 26.
[0064] Further embodiments of the isolator sleeve system 50 may
comprise any of the systems of FIGS. 3, 5a and 5b, or 6a and 6b
together with an isolator (not shown).
[0065] Variations and modifications will occur to those of skill in
the art after reviewing this disclosure. The disclosed features may
be implemented, in any combination and subcombinations (including
multiple dependent combinations and subcombinations), with one or
more other features described herein. The various features
described or illustrated above, including any components thereof,
may be combined or integrated in other systems. Moreover, certain
features may be omitted or not implemented. Examples of changes,
substitutions, and alterations are ascertainable by one skilled in
the art and could be made without departing from the scope of the
information disclosed herein.
[0066] It should be appreciated that the invention is not limited
to the particular embodiments described and illustrated herein but
includes all modifications and variations falling within the scope
of the invention as defined in the appended claims.
* * * * *