This invention is directed to applicators for liquids and liquid reservoir containers for such applicators. It is particularly but not exclusively concerned with applicators for applying surgical prep liquids to the skin.
The conventional preparation of a patient's skin for surgery includes an extended period of cleaning using soap or the like, followed by the application of an antiseptic or disinfectant solution.
The oldest—and still widespread—method of applying the disinfectant is by dipping a swab, sponge or pad, held in forceps, into a dish of liquid and wiping it over the skin. Spent swabs/pads are continually discarded and fresh ones taken. The disinfectant (“pre-prep solution”) is usually alcohol-based and may contain ingredients such as iodine that irritate or burn the skin. Moreover surgical prep is often done under severe time pressure and subject to safety and effectiveness there is every interest in doing it as quickly as possible.
Over the years many proposals have been made for hand-held applicator devices for applying surgical prep solution, incorporating an applicator head with a pad, sponge or other soft or deformable permeable element to be wiped across the skin, and a reservoir of the surgical prep solution—usually contained in a handle of the device—communicating with the applicator pad to feed solution. This can make the application more efficient by avoiding the repeated dipping and the discarding and replacement of spent swabs. By providing the solution in a sealed sterile vial, ampoule or cartridge, which can be opened inside the device by engaging it appropriately with an opening structure in the applicator body (e.g. a spike or cutter built into the applicator body to rupture a membrane or film closure on the front of the cartridge, or an oblique shoulder to break off the tip of a glass vial) operation of these devices can be neater and easier than swabs.
Surgical prep solutions are desirably coloured or dyed, to show where the solution has been applied. This presents a problem with pre-loaded containers for applicators, because usually the dye additive cannot be included in the solution pre-packaged in the container. Dye compounds have a tendency to interact chemically, degrading both themselves and the disinfectant over time. Moreover they may be unable to withstand the sterilisation conditions needed for the main disinfectant solution. So, dye must be provided separately in the applicator.
U.S. Pat. No. 7,241,065 uses a porous plug impregnated with dye and positioned in the applicator in front of the solution ampoule. Disinfectant solution from the ampoule is coloured as it flows through the plug on the way to the applicator pad. Another proposal provides a solid dye powder on the back of the applicator pad. These proposals may bring assembly problems, and the mixing of dye and disinfectant is likely to be non-uniform over the dispensing lifetime of the applicator.
The issue exists not only for dyes, since there may be other additives or components which could desirably be included in a liquid applied by an applicator using a pre-loaded liquid container, but which for various reasons, such as those mentioned above, cannot be pre-mixed in the pre-loaded liquid. This can apply to solid or liquid additives.
The present application presents new proposals or embodiments for applicators using pre-loaded liquid containers, and for new kinds of pre-loaded container for use with such applicators, addressing the above issues.
The focus of the present disclosure is directed to a liquid applicator such as a surgical prep applicator having an applicator pad at a front part of the applicator attached to an applicator body including a structure for receiving a pre-loaded container of liquid, and defining a flow path for liquid to flow from the container to the applicator pad.
Usually the container will be discrete and received at or in a receiving structure of the applicator body, although it may be shipped in situ. The container has an openable front closure portion which when opened allows liquid to flow from the container into the flow path.
An opening means is provided for opening the front closure portion of the container. Preferably this opening means is provided by structure—typically fixed structure—of the applicator body which interacts directly with the front of the container received there, e.g. a cutter, spike or other penetrating protrusion or projection which pushes into or against the front of the container when the container is moved to an opening position e.g. by pushing the container into or onto the applicator body.
The corresponding openable structure of the container may be a film, foil or other layer that is cut, broken or ruptured, a frangible part which is broken away (as in the known use of glass vials whose front ends are broken off), or a displaceable wall part such as a partition or plug which can be moved (e.g. broken out, swung or slid) out of its position to create an opening for forward flow. The use of a displaceable piston or plug-type closure is novel and is an independent proposal herein.
Alternatively, although this is less preferred, the opening means may be provided at the side or rear of the container, or may indeed be incorporated as part of the container structure, but in any event is operable to open the openable front closure portion of the container e.g. by pushing or cutting through it from behind or from inside.
One proposal is that the container is provided having two chambers, a front chamber and a rear chamber, with a liquid-impermeable barrier or partition between them. The front chamber has the openable front portion leading into the applicator flow path. The applicator is operable to open the intermediate barrier between the front and rear chambers to allow mixing of first and second respective materials contained in them, at least one and preferably both of which are liquids. The first and second chambers are disposed in series in relation to the flow path, so that in use both the first and second materials pass into the applicator flow path through the openable front structure.
The first and second chambers may be housed or provided in a single main container body, the barrier between them being provided by an intermediate partition. One chamber may be provided as an insert fitted into a mouth of an outer container which also defines the other chamber. Desirably the insert chamber is self-contained, e.g. including the intermediate partition as part of its structure so that it can be filled with its respective material before fitting to the outer container. Preferably the insert chamber is at the front of the container arrangement so that its front opening is, or coincides with, the openable front structure. Preferably one of the chambers is smaller and contains an additive for a main liquid which is in the other, larger chamber. Preferably the smaller chamber is at the front.
The skilled person will understand that by providing enclosed chambers in series, difficulties associated with loose or exposed additive material such a dye can be avoided. Liquid additives can be used. Also it becomes possible to handle these separately, e.g. for a sterilisation process, if one chamber such as an insert chamber is self-contained. When liquid from a rear chamber flows through a front chamber, there is moreover a good opportunity for mixing of liquid and additive.
At a simple level these advantages can be obtained with opening means of a generally known type. For example a simple elongate cutter, spike or prong device in the applicator body may pass through, and open, both the front closure portion and the intermediate barrier which separates the first and second chambers. However we propose herein more sophisticated opening arrangements for the first and second chambers which provide for flexibility in the relative volumes, shapes, handling and assembly of these chambers without requiring extreme formations or movements for the opening operation.
In particular, the present disclosure describes a construction in which, in a said chamber having the intermediate barrier or partition at one end and the openable front closure portion at the other end, one or more longitudinal pusher elements extends inside the chamber relatively moveably between these ends. Either of the respective ends of the pusher structure may be integral with, or discrete from but adjacent to, the corresponding closure, barrier or actuating element at that end.
The principle is that an operating movement applied at one end, e.g. the action of a cutter, spike or pusher opening a closure at that end, is transmitted to the other end by a follower action of the internal pusher element(s) whereby it operative to open the intermediate barrier or partition without the operating movement needing to be large.
The preferred structure of this internal pusher or follower arrangement depends on the nature of the closures at either end of the chamber concerned. Preferably this feature is embodied in a self-contained insert chamber as mentioned above. If the intermediate closure is a rupturable layer e.g. film or foil, the pusher or follower has an end with a cutter, spike or the like protrusion to rupture it. If the intermediate closure is a plug, flap or piston which is opened by being pushed out of an opening, in which it fits sealingly, into a space beyond, then the pusher or follower structure may be designed simply to push on this or—especially in the case of a piston or plug structure—be formed fixed to or integral with it. The latter options have the advantage that the longitudinal alignment of the pusher or follower structure in the chamber is then naturally maintained.
As regards the structure at the other end of the chamber (i.e. remote from the intermediate closure, typically at the front), this also may be any of a rupturable layer or displaceable wall portion e.g. film, foil, plug, flap or piston as mentioned. The opening means on the applicator body is adapted accordingly. Usually the opening means operates by the front of the container being pushed into engagement with a projecting formation of the opening means through an operating stroke (distance). Over this operating stroke the opening means formation also pushes the pusher element(s)—either directly or via part of the front closure—to open the intermediate closure too.
The relative timing of the openings of the front closure and of the intermediate closure can be adjusted by the mechanism used. However we particularly prefer a mechanism which opens the intermediate closure at an intermediate stage of the operating stroke, before the front closure is opened. This gives an opportunity for mixing of the first and second materials before they flow out of the container. More especially we prefer that means are provided for arresting or interrupting the actuating movement stroke at the intermediate stage to give time for this mixing to take place.
This may be e.g. by a stepped formation of a path or track, on one of the container and the receiving part of the applicator body, for a projection on the other. The path or track can be formed with an intermediate abutment which meets the projection to interrupt the operating stroke—which is typically a direct push—at the intermediate point, and which can then be overcome or avoided to complete the stroke e.g. by a lateral or turning movement of the container relative to the body.
In one embodiment the closures at both ends of an insert chamber are provided by plug formations connected by one or more longitudinal members constituting the mentioned pusher or follower structure, so that when the plug at the front end is pushed in, the plug at the rear end is pushed out. This closure and pusher structure can be contained in an insert shell which also provides or supports the front and rear sealing seats for the plugs.
To provide the above-mentioned two-stage opening, the movement needed to open the front closure is more than that for the intermediate closure, e.g. by having a front plug with a longer sealed stroke in its sealing seat than the rear plug.
Where plugs or pistons are used, these may be supplemented by films or foils to assure adequate sealing.
A further proposal or embodiment is that the applicator body, at or immediately downstream of the opening means, has one or more baffle structures or tortuous flow formations to promote mixing of the liquid and the additive material as they pass to the applicator pad.
A container providing two chambers according to any of the proposals or embodiments above is an independent aspect of the present disclosure. Such a container pre-filled with first and/or second materials in the respective chambers is a further independent aspect. So also is a procedure of assembling such a container, including pre-filling of the materials and assembly of the first and second chambers to one another.
Desirably the container is substantially cylindrical or has a substantially cylindrical main body part. Where an insert chamber is used, this may fit inside a main wall of the main container without a corresponding enlargement. In known manner a cylindrical container can fit closely into a corresponding tubular guide portion of the applicator body leading to the opening means.
The opening means, e.g. fixed internal structure of the applicator body, can be formed integrally within this tubular receiving or guide structure. Downstream of the opening means there is desirably an antechamber in which the mixed materials can accumulate upstream of the permeable applicator pad. The applicator body desirably provides a rigid flange or support portion to which the permeable pad is secured. However the form of the permeable pad and its mounting is not critical in the present invention and may be in accordance with any known proposals.
Desirably a flow distributor element is positioned over the back surfaces of the pad to moderate and distribute the liquid flow into the pad. This may be in accordance with the disclosure of our co-pending PCT application also filed 10 Aug. 2010 and entitled “APPLICATORS”, reference GPS/BP6705032, the entire contents of which are incorporated herein by reference.
The applicator may include a vent opening communicating into the flow space between the back surface of the permeable pad and the front opening position for the container. This helps smooth emptying of the container, which is usually closed at the rear.
Embodiments of the proposals are now described by way of example, with reference to the accompanying drawings in which:
For the purpose of promoting an understanding of the principles of the invention, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended. Any alterations and further modifications in the described embodiments, and any further applications of the principles of the invention as described herein are contemplated as would normally occur to one skilled in the art to which the invention relates. One embodiment of the invention is shown in great detail, although it will be apparent to those skilled in the relevant art that some features that are not relevant to the present invention may not be shown for the sake of clarity.
With reference to
A rear cylindrical part of the applicator body 2 constitutes a guide casing or receiving portion 21 for the disinfectant cartridge 5, which slides into it with a close fit. Between the receiving portion 21 and the antechamber 28, a container-opening structure 42 is provided in the body 2, here in the form of an axially-extending central rearward projection directed onto the front of the cartridge 5. It may have a cross or star cross-section for rigidity. Immediately downstream of the opening formation 42 a partition 44 with a central hole 441 spans the tube interior. A circular baffle element 422 near the bottom of the opening structure 42 is aligned axially immediately upstream of the hole 441. Thus, liquid which flows from the cartridge must flow around the circular baffle 422 and then inwardly to pass through the hole 441, promoting mixing of components.
The cartridge 5 is now described in more detail. It contains a main volume of disinfectant liquid in a rear chamber 51 and a small volume of a dye or other additive in a front chamber 52. The entire cartridge has a generally cylindrical outer casing 53 with an open front end or mouth 531. The disinfectant liquid may be of any suitable kind.
A chamber insert 54 is plugged into the mouth 531 of the main cartridge tube 53, held in place by snap ribs adjacent the mouth, and closes it off as seen in the figures. The chamber insert comprises an outer sleeve or shell 541, a one-piece plastics unit which is open at both ends. Its front end has outward snap formations 542 which lock into the mouth of the main tube 53, and a concentric inner sleeve portion 543 carrying a sealing lip 545 at its rear edge. The sealing lip is spaced by a distance “x” from the front of the sleeve 541. This inner sleeve 543 provides the actual mouth opening 544 of the chamber insert 54.
The rear end of the sleeve 541 has a simple circular opening 546 with small snap grooves 5461 around the inside.
The other main component of the insert 54 is a closure slide or plug member 57. It comprises a rear plug portion 571 with external beads which plug securely into the rear mouth 546 of the insert's sleeve 541. It has a front plug portion 572 with a smooth uniform outer diameter region which fits sealingly through the sealing lip 545 of the inner sleeve segment 543 at the front of the unit, and has a front edge which lies substantially flush with the mouth opening 544 at the front of the unit, and is closed off with a foil or polymeric sealing film 579.
Between these front and rear plugs 572,571 the closure slide 57 has a rigid structure of legs 575 and windows 576, spaced substantially inwardly from the inner wall of the shell 541. In this embodiment the legs 575 are provided as continuations of the tubular wall of the front plug 572, for simplicity and strength. However their only necessary function is to provide a connection between the front and rear plugs which is adequately strong in compression (for pushing out the rear plug) without isolating part of the interior volume. Therefore many arrangements e.g. of single or multiple struts are possible.
Operation of the device can be understood from
Pushing the cartridge 5 as far as possible into the guide casing 21, as shown in
Referring to
It is important that the cartridge 5 is not pushed in during casual handling or shipping, inadvertently releasing its contents. However it must be simple to push it in when actually needed. We show here a flexible arcuate stopper rib 295 extending across the mouth of the notch at a start level corresponding to initiation of the actuation stroke, to stop accidental initiation of the operating stroke.
The notch 29 has a wider entry or guide region 280 above the flexible stopper rib, extending down below the circular edge of the casing 21, to avoid exposing the rib 295 to damage. It also protects the lug from accidental engagements. This entry or guide region 280 includes an abutment or shoulder 291 where the lug 55 can rest without resting against the rib 295. This corresponds to a position as in
With a single-chamber cartridge, or with a two-chamber cartridge whose front and intermediate closures may open at the same time, the two-stage staggered track formation is not relevant but the flexible rib idea, optionally also with the preliminary guide zone of the notch, is generally useful.
The initial movement of the cutter 43 breaks through the film 1579 so that dye starts to escape through the front opening:
This embodiment does not provide the two-stage confined mixing procedure of the first embodiment, so the two-stage external control track need not be used. It illustrates the wide range of possibilities available with the present two-chamber concepts. The skilled reader will understand that various configurations are possible exploiting the ideas described herein. For example the dye could be provided in a small rear chamber, and admitted forwardly to the front main chamber, opening a partition between them by means of an actuator e.g. a plunger or pusher at the back of the cartridge. Another possibility is that the front capsule or chamber containing the dye need not be fitted right inside the mouth of the main cartridge tube, but could instead fit into it only partly, or indeed be separate from it, the dye (additive) chamber and disinfectant (main liquid) cartridge being inserted in sequence. This would call for respective rear and front seals for the front and rear chambers, but these could be ruptured or otherwise opened together by a suitable formation at the rear of a pusher member in the front chamber. The concept can be adapted to operate with various combinations of different kinds of seals or closure elements.
While the invention has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character, it being understood that only the preferred embodiment has been shown and described and that all changes, equivalents, and modifications that come within the spirit of the inventions defined by following claims are desired to be protected. All publications, patents, and patent applications cited in this specification are herein incorporated by reference as if each individual publication, patent, or patent application were specifically and individually indicated to be incorporated by reference and set forth in its entirety herein.
Number | Date | Country | Kind |
---|---|---|---|
0913972.6 | Aug 2009 | GB | national |
This application is a continuation of International Application No. PCT/GB2010/001521 filed Aug. 10, 2010 which claims the foreign priority benefit of GB 0913972.6 filed Aug. 10, 2009, both of which are hereby incorporated by reference.
Number | Name | Date | Kind |
---|---|---|---|
2976560 | Turner | Mar 1961 | A |
2998822 | Birch et al. | Sep 1961 | A |
3324855 | Heimlich et al. | Jun 1967 | A |
3349966 | Schwartzman | Oct 1967 | A |
3399020 | Margolis et al. | Aug 1968 | A |
3519364 | Truhan | Jul 1970 | A |
3601287 | Schwartzman | Aug 1971 | A |
3636922 | Ketner | Jan 1972 | A |
3891331 | Avery | Jun 1975 | A |
4084910 | LaRosa | Apr 1978 | A |
4140409 | DeVries | Feb 1979 | A |
4148318 | Meyer | Apr 1979 | A |
4173978 | Brown | Nov 1979 | A |
4183684 | Avery, Jr. | Jan 1980 | A |
4201491 | Kohler | May 1980 | A |
4225254 | Holberg et al. | Sep 1980 | A |
4415288 | Gordon et al. | Nov 1983 | A |
4498796 | Gordon et al. | Feb 1985 | A |
4507111 | Gordon et al. | Mar 1985 | A |
4578055 | Fischer | Mar 1986 | A |
4863422 | Stanley | Sep 1989 | A |
4925327 | Wirt | May 1990 | A |
5006004 | Dirksing et al. | Apr 1991 | A |
5015228 | Columbus et al. | May 1991 | A |
5019033 | Geria | May 1991 | A |
5088849 | Johnson et al. | Feb 1992 | A |
5147337 | Plone | Sep 1992 | A |
5288159 | Wirt | Feb 1994 | A |
5308180 | Pournoor et al. | May 1994 | A |
5435660 | Wirt | Jul 1995 | A |
5445462 | Johnson et al. | Aug 1995 | A |
5489280 | Russell | Feb 1996 | A |
5509744 | Frazier | Apr 1996 | A |
5568988 | Knox et al. | Oct 1996 | A |
5658084 | Wirt | Aug 1997 | A |
5713843 | Vangsness | Feb 1998 | A |
5769552 | Kelley et al. | Jun 1998 | A |
5775826 | Miller | Jul 1998 | A |
5791801 | Miller | Aug 1998 | A |
5871297 | Rogers et al. | Feb 1999 | A |
5908256 | Bernstein | Jun 1999 | A |
5934296 | Clay | Aug 1999 | A |
6190367 | Hall | Feb 2001 | B1 |
6238117 | Griebel et al. | May 2001 | B1 |
6371675 | Hoang et al. | Apr 2002 | B1 |
6422778 | Baumann et al. | Jul 2002 | B2 |
6471095 | Cann | Oct 2002 | B1 |
6475701 | Ohno et al. | Nov 2002 | B2 |
6488665 | Severin et al. | Dec 2002 | B1 |
6505985 | Hidle et al. | Jan 2003 | B1 |
6533484 | Osei et al. | Mar 2003 | B1 |
6536975 | Tufts | Mar 2003 | B1 |
6595696 | Zellak | Jul 2003 | B1 |
6616363 | Guillaume et al. | Sep 2003 | B1 |
6672784 | Baumann et al. | Jan 2004 | B2 |
6689103 | Palasis | Feb 2004 | B1 |
6729786 | Tufts et al. | May 2004 | B1 |
6743211 | Prausnitz et al. | Jun 2004 | B1 |
6755586 | Frazier | Jun 2004 | B1 |
6773193 | Delage | Aug 2004 | B2 |
6805682 | Campbell | Oct 2004 | B1 |
6811341 | Crane | Nov 2004 | B2 |
6869242 | May | Mar 2005 | B2 |
6909339 | Yonekura et al. | Jun 2005 | B2 |
6910822 | Hidle et al. | Jun 2005 | B2 |
6916133 | Hoang et al. | Jul 2005 | B2 |
6916137 | Shiraiwa | Jul 2005 | B2 |
6991394 | Tufts et al. | Jan 2006 | B2 |
7090422 | Baumann et al. | Aug 2006 | B2 |
7201525 | Mohiuddin | Apr 2007 | B2 |
7261701 | Davis et al. | Aug 2007 | B2 |
7866907 | Cable, Jr. et al. | Jan 2011 | B2 |
8002486 | Tran | Aug 2011 | B1 |
8113731 | Cable, Jr. et al. | Feb 2012 | B2 |
8348537 | Cable, Jr. et al. | Jan 2013 | B2 |
20010055511 | Baumann et al. | Dec 2001 | A1 |
20020076255 | Hoang et al. | Jun 2002 | A1 |
20020076258 | Crosby et al. | Jun 2002 | A1 |
20030049069 | Osei et al. | Mar 2003 | A1 |
20030060746 | Mark | Mar 2003 | A1 |
20030068190 | Hidle et al. | Apr 2003 | A1 |
20030118629 | Scholz et al. | Jun 2003 | A1 |
20030149106 | Mosbey et al. | Aug 2003 | A1 |
20030194447 | Scholz et al. | Oct 2003 | A1 |
20040068218 | Davis et al. | Apr 2004 | A1 |
20040114988 | Baumann | Jun 2004 | A1 |
20040162533 | Alley | Aug 2004 | A1 |
20040179888 | Tufts et al. | Sep 2004 | A1 |
20040240927 | Hoang et al. | Dec 2004 | A1 |
20040267182 | Davis et al. | Dec 2004 | A1 |
20060039742 | Cable et al. | Feb 2006 | A1 |
20060072962 | Cybulski et al. | Apr 2006 | A1 |
20070147947 | Stenton | Jun 2007 | A1 |
Number | Date | Country |
---|---|---|
20 2005 012686 | Oct 2005 | DE |
WO 8504794 | Nov 1985 | WO |
WO 9413352 | Jun 1994 | WO |
WO 9503734 | Feb 1995 | WO |
WO 9951184 | Oct 1999 | WO |
WO 0010889 | Mar 2000 | WO |
WO 0249708 | Jun 2002 | WO |
WO 2004062709 | Jul 2004 | WO |
Entry |
---|
International Search Report and Written Opinion for WO 2011/018621 dated Mar. 29, 2011. |
International Search Report and Written Opinion for WO 2011/018622 dated Jan. 27, 2011. |
Number | Date | Country | |
---|---|---|---|
20120219346 A1 | Aug 2012 | US |
Number | Date | Country | |
---|---|---|---|
Parent | PCT/GB2010/001521 | Aug 2010 | US |
Child | 13369848 | US |