The present invention relates generally to the field of containment, storage and delivery of fluids, and more particularly to a capping device, bottle adapter or fluid transfer coupling for facilitating the transfer of fluids between a container or pharmacy bottle and a syringe.
Various containers are used for the collection, storage and delivery of fluids such as medications, supplements, breast milk, formula, and the like. For example, when dispensing fluid medications that are commonly stored in larger volumes in a pharmacy bottle, and dispensed in smaller prescribed quantities into a smaller container, a syringe may be used to measure and transfer the fluid. Often a transfer lid or cap is used on the larger volume container, allowing easy repeated dispensation from the container. Smaller volume containers typically accept “press-in” or stepped enteral-only adapters for transferring the fluids between the syringe and container.
Generally, with the syringe engaged with the adapter and the connector engaged with the opening of the bottle, a plunger of the syringe can be retracted to withdraw fluids from the bottle to within the barrel of the syringe. However, due to the configuration of the adapter, at least some fluid within the bottle cannot be withdrawn therefrom, for example, as the height or extension of the syringe coupling within the opening of the adapter is positioned above a floor surface or bottom interior portion of the adapter. In most cases, the remaining fluid within the bottle can range between about 0.50 g to about 1.50 g, for example between about 0.68 g to about 1.12 g according to some examples.
Continued improvements to the transfer and dispensation of fluids such as fluid medications is sought. It is to the provision of improved fluid transfer connectors meeting these and other needs that the present invention is primarily directed.
Summary
In example embodiments, the present invention provides a capping device or lid, bottle adapter or fluid transfer coupling for facilitating in the transfer of fluids from a pharmacy bottle or other container to a syringe or other fluid transfer means.
In one aspect, the present invention relates to a bottle adapter connector including a generally cylindrical body having an outer peripheral surface and an inner peripheral surface; a recess defined by the inner peripheral surface of the body, a base member, and a male coupling generally centrally positioned on the base member, the male coupling includes a conduit extending therethrough.
In example embodiments, the male coupling includes a male ENFit compatible coupling. In example embodiments, the male ENFit compatible coupling is configured for engagement with a female ENFit compatible coupling. In example embodiments, the female ENFit compatible coupling includes a dosing control coupling for extension within a portion of the conduit of the male ENFit compatible coupling.
In example embodiments, the outer peripheral surface includes a plurality of laterally offset flanges for providing frictional engagement with an opening of a medicine bottle. In example embodiments, the bottle adapter has a diameter of between about 12-28 millimeters.
In example embodiments, the adapter can further include an outer collar and a sealing mechanism, wherein the sealing mechanism is configured for fitting around the male coupling and within a recess defined between the outer collar and the male coupling. In example embodiments, the sealing mechanism includes a substantially resilient grommet having a first open end for receiving the male coupling and a substantially closed second end. In example embodiments, the resilient grommet is formed from silicone.
In example embodiments, a cap can be tethered to the body of the bottle adapter. In example embodiments, the base member is substantially flexible and elastically deformable such that the male coupling is movable in an axial direction. In example embodiments, the male coupling extends beyond an end of the body such that closure of a cap atop the connector causes axial displacement of the male coupling, and wherein the conduit is generally sealed with the cap.
In another aspect, the present invention relates to a fluid transfer lid including a generally circular top panel, a first coupling and an attachment collar. The first coupling includes a length and extends longitudinally along a first axis from the circular top panel, and wherein a lumen extends generally axially along the first axis through the first coupling. The attachment collar extends in a second direction from the circular top panel, wherein an internal circumferential face thereof being threaded to releasably engage corresponding threads of a container.
In example embodiments, the first coupling includes a female enteral-only coupling. In example embodiments, the lid can further include an adapter tethered to the lid, wherein the adapter includes a male ENFit compatible coupling and a male enteral-only coupling generally axially aligned and oppositely extending from a central flange member. In example embodiments, the adapter further includes a closure tethered thereto.
In example embodiments, the lid further includes a second coupling having a length and extending longitudinally along a second axis from the circular top panel, wherein the second axis is generally parallel and spaced a distance relative to the first axis. In example embodiments, the second coupling includes a lumen extending generally axially along the second axis. In example embodiments, the second coupling includes a male ENFit compatible coupling.
In example embodiments, the lid can further include closures tethered to the lid and capable of moving independently between an open configuration with the closure removed and a closed configuration with the closure engaged with the coupling and sealing the lumen thereof.
In yet another aspect, the present invention relates to a fluid transfer adapter including a disc-shaped body having a first end and a second end, the disc-shaped outer body defining an outer diameter of at least about 2.25 inches, the body comprising a first surface defining a first coupling and a second surface comprising a second coupling. In example embodiments, a conduit extends entirely through the couplings from the first end to the second end.
In example embodiments, the first coupling is generally centrally-positioned on the body and extends towards the first end, and the second coupling is generally axially aligned with the first coupling and extends towards the second end. In example embodiments, the first coupling includes a male ENFit compatible coupling and the second coupling includes a male enteral-only coupling.
In yet another aspect, the present invention relates to a bottle adapter connector for connecting with an opening of a bottle and for withdrawing fluids from the bottle and within a syringe connected to the bottle adapter connector. The connector includes a generally cylindrical body having an outer peripheral surface and an inner peripheral surface, a recess defined by the inner peripheral surface of the body, a base member, and a male coupling generally centrally positioned on the base member, the male coupling comprising a conduit extending therethrough, and wherein the base member includes a sloped surface that is sloped inwardly towards the conduit such that a substantial amount, if not all, of the fluid within the bottle, is directed to flow within the conduit and further into the syringe when it is desired to withdraw fluids from the bottle.
In yet another aspect, the present invention relates to a bottle adapter connector including a generally cylindrical body extending between a first end and a second end, and having an outer peripheral surface and an inner peripheral surface. A recess is defined by the inner peripheral surface of the body and accessible from the first end, a base portion positioned at the second end, and a male coupling is generally centrally positioned on the base portion and projects towards the first end. The male coupling includes a conduit extending therethrough. In example embodiments, the base portion includes a sloped surface extending towards the first end and up to the conduit of the male coupling.
In example embodiments, the male coupling includes a male ENFit compatible coupling. In example embodiments, the male ENFit compatible coupling is configured for engagement with a female ENFit compatible coupling. In example embodiments, the female ENFit compatible coupling further includes a dosing control coupling for extension within a portion of the conduit of the male ENFit compatible coupling. In example embodiments, the outer peripheral surface includes a plurality of laterally offset flanges for providing frictional engagement with an opening or mouth of a medicine bottle. In example embodiments, the cylindrical body of the bottle adapter connector includes a diameter of between about 12-28 millimeters. In example embodiments, the connector further includes a shelf extending outwardly from the outer peripheral surface of the cylindrical body. In example embodiments, the sloped surface is angled between about 0.5-89.5 degrees relative to the extension of the cylindrical body. In example embodiments, the sloped surface is angled between about 30-70 degrees relative to the extension of the cylindrical body. In example embodiments, a surface of the shelf is configured for engagement with an end portion of a mouth of a bottle when the connector is fully inserted within the mouth of the bottle. In example embodiments, further includes a lead-in portion defined at the second end. In example embodiments, the male coupling extends beyond an end of the body such that closure of a cap atop the connector causes the conduit of the male coupling to be sealed with the cap. In example embodiments, at least a portion of the sloped surface includes a texturized surface. In example embodiments, the texturized surface includes a hydrophobic or oleophobic surface.
In yet another example embodiment, the present invention relates to a bottle adapter connector for connecting with an opening or mouth of a bottle and for withdrawing fluids from the bottle and within a syringe connected to the bottle adapter connector. In example embodiments, the connector includes a generally cylindrical body having an outer peripheral surface and an inner peripheral surface. A recess is defined by the inner peripheral surface of the body, a base member, and a male coupling generally centrally positioned on the base member. The male coupling includes a conduit extending therethrough. In example embodiments, the base member includes a sloped surface that is sloped inwardly towards the conduit such that a substantial amount, if not all, of the fluid within the bottle, is directed to flow within the conduit and further into the syringe when it is desired to withdraw fluids from the bottle.
In example embodiments, the sloped surface is angled between about 30-70 degrees relative to the extension of the cylindrical body. In example embodiments, the male coupling comprises a male ENFit compatible coupling. In example embodiments, the male ENFit compatible coupling is configured for engagement with a female ENFit compatible coupling. In example embodiments, the female ENFit compatible coupling further includes a dosing control coupling for extension within a portion of the conduit of the male ENFit compatible coupling. In example embodiments, at least a portion of the sloped surface includes a texturized, hydrophobic or oleophobic surface.
These and other aspects, features and advantages of example embodiments of the invention will be understood with reference to the drawing figures and detailed description herein, and will be realized by means of the various elements and combinations particularly pointed out in the appended claims. It is to be understood that both the foregoing general description and the following brief description of the drawings and detailed description of the invention are exemplary and explanatory of preferred embodiments of the invention, and are not restrictive of the invention, as claimed.
The present invention may be understood more readily by reference to the following detailed description of the invention taken in connection with the accompanying drawing figures, which form a part of this disclosure. It is to be understood that this invention is not limited to the specific devices, methods, conditions or parameters described and/or shown herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only and is not intended to be limiting of the claimed invention. Any and all patents and other publications identified in this specification are incorporated by reference as though fully set forth herein.
Also, as used in the specification including the appended claims, the singular forms “a,” “an,” and “the” include the plural, and reference to a particular numerical value includes at least that particular value, unless the context clearly dictates otherwise. Ranges may be expressed herein as from “about” or “approximately” one particular value and/or to “about” or “approximately” another particular value. When such a range is expressed, another embodiment includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another embodiment.
With reference now to the drawing figures, wherein like reference numbers represent corresponding parts throughout the several views,
According to example embodiments, the fluid transfer connectors of the present invention comprise ENFit compatible connectors and are configured for coupling engagement with ENFit connectors, for example, according to the ENFit design standard, ISO 80369-3, which is incorporated herein by reference. Preferably, the fluid transfer connectors can be sized as desired, for example, to accommodate coupling with containers or bottles of different sized openings. According to some example forms of the invention, the fluid transfer connectors comprise both enteral-only connectors and ENFit compatible connectors, for example, for providing compatible coupling engagement with enteral-only connectors and ENFit compatible connectors. Preferably, any of the fluid transfer connectors as described herein can comprise both enteral-only and ENFit compatible connectors as desired.
In example embodiments, the connector 10 comprises a recess 16 defined by an inner peripheral surface 18 of the body 12, a base member or floor 20, and a male coupling generally centrally-positioned on the floor 20 and extending towards the upper surface 15a. In example embodiments, a central conduit 24 extends entirely through the male coupling 22 along an elongate axis Y that is generally centrally-positioned in the floor 20 and axially aligned with the body 12. In example embodiments, the end coupling FC of a syringe S is compatible for removable engagement with the male coupling 22, for example, such that the syringe can be coupled to the connector 10 to allow transfer of the fluids or medicine between the syringe S and the pharmacy bottle, from the pharmacy bottle to the syringe or from the syringe to the pharmacy bottle. In example embodiments, the male coupling 22 can comprise a male ENFit compatible coupling and the end coupling FC can comprise a female ENFit compatible coupling. According to some example embodiments, the syringe S can comprise a dosing control coupling or low dose tip LT, for example, which is compatible for fitting within the conduit 24 when the end coupling FC is coupled with the male coupling 22, and which preferably substantially if not entirely eliminates dosing inaccuracies (see
In example embodiments, the floor surface 120 can be configured to provide at least some amount of flexure or elasticity such that the male coupling 122 can axially move when engaged with the cap L. In some example embodiments, the floor surface 120 can be substantially thin relative to the other portions of the connector 100, or can be formed from one or more flexible and resilient materials that allow for at least some displacement. According to one example embodiment, the floor surface 120 can be formed from a different material relative to the material forming the rest of the connector 100. For example, in some example embodiments, the floor surface 120 can be co-molded or comprise a mixture of two or more materials such that the floor surface 120 exhibits a greater amount of flexibility and elasticity compared to the other components or features of the connector 100.
As depicted in
In example embodiments, the tether 334 extends outwardly from an upper portion of the body 12 near the outer peripheral flanges 314. Preferably, the tether 334 comprises a living hinge such that the closure 326 coupled thereto is pivotable between the open and closed configurations. In example embodiments, the living hinge is substantially flexible and resilient to permit the closure 326 to pivot at least about 180 degrees. In example embodiments, the male coupling 322 is substantially shorter than the male couplings as described above, for example, such that a cap L can be fitted and coupled to the bottle with the closure 326 in the closed configuration and sealed with the male coupling 322. Thus, according to one example embodiment of the present invention, the closure 326, when sealingly engaged with the male coupling 322 and in the closed configuration (e.g., with the central plug 332 fitted within the conduit 324 and the collar 330 surrounding the male coupling 322), is generally at least about flush with the upper portion of the outer collar body, for example, to allow coupling engagement of the cap L with the bottle. As depicted in
In example embodiments, a closure 430 can be provided for sealing the conduit 422 from the elements. In example embodiments, the closure 430 comprises an outer collar member 432, a central plug configured for frictional engagement with the conduit 422. In example embodiments, the closure 430 can be tethered to the connector 400, for example wherein tether 436 is generally flexible and resilient to allow for positioning the closure 430 in either of the open or closed configurations.
An attachment collar 522 extends in a second or proximal direction from the top panel 510, and an internal circumferential face thereof is threaded to releasably engage corresponding threads at the top of the containment shell of the container. An exterior circumferential face of the attachment collar 522 of the transfer lid 500 optionally comprises spaced intentions, ridges, recesses, or other gripping features 524 to assist a user in installing and removing the transfer lid 500 onto and from the containment shell of the container. Optionally, closures 540 are provided for sealing with the first and second transfer ports 512, 516. In example embodiments, one of the closures 540 (e.g., for sealing with the first transfer port 512) comprises a first closure 542 comprising a flange or lip 544, a plug (unshown), an outer collar or lip 546, and a tether 547. Similarly, a second closure 550 is provided for sealingly engaging the second transfer port 516. In example embodiments, the second closure 550 comprises a flange or lip 552, a plug 554 and a tether 556. In example embodiments, the closures 540 can be used independently of each other, for example such that one of them can be in the closed position and engaged with one of the transfer ports while the other one is in the open position and an end connector of a syringe is removably mounted to the other of the transfer ports.
In example embodiments, an adapter 630 and a closure 642 can be provided with the transfer lid 600. For example, according to example embodiments, the adapter 630 comprises a central flange member 632, a first connector 634, a second connector 636, and a conduit 640 extending entirely through the connectors 634, 636. The closure 642 comprises a flange or lip 644, a plug 646, and an outer collar or lip 650. In example embodiments, a tether generally connects the adapter 630 and closure 642 with the transfer lid 600. For example, according to one example embodiment, a first tether 652 is provided for connecting the transfer lid 600 with the adapter 630, and a second tether 654 is provided for connecting the adapter 630 with the closure 642. In use, the transfer lid 600 can be fastened to a bottle for facilitating the transfer of fluids between the bottle and the syringe. If the syringe comprises a male enteral-only end coupling, the transfer port 612 can be utilized to facilitate the transfer of fluids therebetween. If the syringe S comprises a ENFit compatible coupling, the adapter 630 is connected with the transfer port 612, for example, such that the first connector 634 is coupled with the transfer port 612 and the second connector 636 is coupled with the ENFit compatible coupling of the syringe.
Accordingly, by the tethered adapter 630, the transfer lid 600 accommodates both enteral-only and ENFit compatible connectors. Accordingly, according to one example embodiment, the present invention relates to a transfer lid comprising a female enteral only coupling, and comprising an adapter tethered thereto such that the lid can accommodate both enteral-only and ENFit compatible connectors. As such, the transfer lids 500, 600 preferably provide multiple couplings such that connectors or syringes having either enteral-only or ENFit compatible couplings can be fitted therewith to facilitate the transfer of fluids between the bottle and syringe.
As shown in
In example embodiments, the disc-shaped body 710 is preferably sized and configured to prevent the fluid transfer adapter or any portions thereof from presenting a choking hazard, for example for young children. In example embodiments, the fluid transfer adapter including the flange has a minimum dimension of at least about 2.25 inches by at least about 1.25 inches, or is otherwise sized and configured to prevent the fluid transfer adapter from passing through a 2.25 inches×1.25 inches choke test cylinder in compliance with 37 C.F.R. 1501.4. According to one example embodiment, the flange comprises a circular disc having a diameter D2 of at least about 2.25 inches, for example 2½ inches or 3 inches. In alternate embodiments, the flange may have a square, rectangular, polygonal, elliptical or otherwise shaped configuration, and/or may be larger or smaller than the above specified dimensions, for example 1½ inches, 4 inches, etc. Optionally, one or more openings can be formed within one or more portions of the body as desired. In example embodiments, at least a portion of the body is shaped to provide a gripping surface or feature to facilitate the gripping thereof, for example, when connecting the adapter with the bottle adapter and the syringe, or for example, when it is desired to disengage the adapter from either of the syringe or the bottle adapter. According to another example embodiment of the present invention, the male ENFit compatible connector of the adapter is replaced with a female ENFit compatible connector, for example, such that a syringe comprising a male ENFit compatible connector can be connected to the pharmacy bottle adapter.
As shown in
According to one example embodiment, a circular array of five generally cylindrical openings extend entirely through the body. In example embodiments, the openings are substantially uniform (e.g., generally the same size and equally spaced apart), and an edge defining each opening is radiused to provide a smooth transition between the surfaces of the body. According to another example embodiment, the body can define a plurality of openings, for example, an outer and inner array of circular openings. According to example embodiments, the outer array comprises about twelve openings and the inner array comprises about twelve openings. In example embodiments, the openings of the outer and inner array are both generally circular in shape, and wherein the openings of the outer array are substantially larger than the openings of the inner array. In alternate embodiments, the disc-shaped body can comprise a matrix of openings formed through at least a portion of the disc-shaped body. For example, the disc-shaped body can comprise a matrix of square openings formed through the body. Optionally, the openings can be shaped as desired. According to example embodiments of the present invention, the openings provide for an enhanced gripping surface, for example, such that the body can be easily grasped by a user and manipulated.
In example embodiments and as described above, commonly used bottles most frequently used in medicine practice range between about 2-16 ounces, and the opening thereof will generally vary according to its volume. In example embodiments, the connector 1200 can be sized as desired, but can at least be provided in sizes compatible with bottle sizes (and the openings thereof) most frequently used in medicine practice, for example, such that the cylindrical body comprises a diameter D1 of about 10-40 millimeters, and between about 12-38 millimeters according to one example embodiment (see
In example embodiments, the flanges 1214 are generally laterally offset from each other and extend around the entirety of the body to define a continuous flange for providing frictional and sealing engagement with an internal surface or opening of the bottle or container B. In example embodiments, the flanges 1214 comprise a thickness T1 and generally extend a length L1 outwardly from the outer peripheral surface 1213, and the flanges 1214 are generally are laterally offset or spaced apart to define a length L2 therebetween. According to example embodiments, the thickness T1 is between about 0.125-1 millimeter, more preferably about 0.54 millimeters according to one example embodiment, the length L1 is between about 1-4 millimeters, more preferably about 2.8 millimeters according to one example embodiment, and the length L2 is between about 1.5-5 millimeters, more preferably about 3.41 millimeters according to one example embodiment. In example embodiments, the shelf 1216 comprises a thickness T2 and extends outwardly from the cylindrical body 1212 to define an outer diameter D3. In example embodiments, the thickness T2 is generally between about 0.35-1.75 millimeters, for example, about 1 millimeter according to one example embodiment. The outer diameter D3 is generally sized to be generally similar to the outer diameter of the opening of the bottle B (see
In example embodiments, the adapter 1200 comprises an annular recess 1220 defined by an inner peripheral surface 1221 of the cylindrical body 1212, a base member or floor 1226, and a male coupling 1222 generally centrally-positioned on the floor 1226. According to example embodiments, the cylindrical body comprises an inner diameter D2 of between about 10.4-39.8 millimeters (e.g., taken from opposite sides of the inner peripheral surface 1221), and between about 11.4-34.6 millimeters according to one example embodiment. According to another example embodiment, the inner diameter D2 of the cylindrical body 1212 is between about 13-16.4 millimeters. A height H1 is defined between a lower surface of the shelf 1216 and an upper surface of the upper-most flange 1214, for example, which generally defines the entire length or extension of the connector 1200. However, as depicted in
As described above, the male coupling 1222 can comprise a male ENFit compatible coupling for cooperative and sealing engagement with a female ENFit compatible coupling (see FC of
In example embodiments, the base portion 1226 of the connector 1200 (e.g., furthest most portion inserted within the bottle opening) comprises a sloped surface 1230 that generally extends from the outer peripheral surface 1213 of the cylindrical body 1212 to the lumen 1224 of the male port 1222. In example embodiments, the sloped surface 1230 is generally sloped inwardly to define an angle α. In example embodiments, the angle α is generally between about 0.5-89.5 degrees, for example about 30 degrees according to one example embodiment. Optionally, the sloped surface 1230 can be angled as desired. For example, according to one preferred embodiment, the angle α is about 24 degrees. According to another preferred embodiment, the angle α is about 36 degrees. In example embodiments, the surface 1230 is generally funneled inwardly towards the lumen 1224 such that a substantial amount, if not all, of the fluid within the bottle, is directed to flow within the lumen 1224 and further into the female connector FC of the syringe S. Thus, the connector 1200 preferably allows for the withdrawal of substantially all of the fluid within the bottle B during the transfer of fluid from the bottle B, through the lumen 1224 of the connector 1200, and within the syringe S (see
According to one example embodiment, the fluid remaining within the bottle after attempting to withdrawal the entirety therefrom is about 0.014 g, for example, which is between about 1%-20% of the fluid compared to the fluid remaining within the bottle when using known connectors. Accordingly, the sloped surface 1230 preferably reduces, if not entirely eliminates, the likelihood that any fluid remains within the bottle B when it is desired to withdraw the entirety of the fluid from the bottle B. According to some example embodiments, any of the bottle connectors as depicted in
According to some example embodiments and with reference to
As depicted in
According to another example embodiment of the present invention, one or more portions of the connector 1200 can comprise an EDM surface finish, or for example, a texturized surface finish or being at least partially hydrophobic or oleophobic so as to act as a nonpolar boundary that maximizes the bonding between molecules of the fluid within the container and minimize the area of contact between the molecules of the fluid within the bottle and the texturized surface finish or hydrophobic or oleophobic surface. Thus, the nonpolar layer excludes molecules of the fluid from the surface thereof such that any fluids present at the texturized surface (or other hydrophobic or oleophobic surface) will generally bead and form droplets of fluid. For example, as depicted in
According to yet another example embodiment of the present invention, rather than the sloped surface of the base portion comprising a tapered-off portion 1232, the sloped surface can generally extend along a substantially linear path from the conduit to the outer peripheral surface of the cylindrical body. For example, as depicted in
While the invention has been described with reference to preferred and example embodiments, it will be understood by those skilled in the art that a variety of modifications, additions and deletions are within the scope of the invention, as defined by the following claims.
This application claims the priority benefit of U.S. Provisional Patent Application Ser. No. 62/544,167 filed Aug. 11, 2017, and is a continuation-in-part of U.S. Non-provisional patent application Ser. No. 15/440,105 filed Feb. 23, 2017, which claims the priority benefit of U.S. Provisional Patent Application Ser. No. 62/299,210 filed Feb. 24, 2016, which claims the priority benefit of U.S. Provisional Patent Application Ser. No. 62/384,848 filed Sep. 8, 2016 and U.S. Provisional Patent Application Ser. No. 62/423,484 filed Nov. 17, 2016, all of which are hereby incorporated herein by reference in their entireties.
Number | Date | Country | |
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62544167 | Aug 2017 | US | |
62299210 | Feb 2016 | US | |
62384848 | Sep 2016 | US | |
62423484 | Nov 2016 | US |
Number | Date | Country | |
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Parent | 15440105 | Feb 2017 | US |
Child | 16100774 | US |