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.

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

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.