EP3664767B1 - Fluid transfer connector - Google Patents
Fluid transfer connector Download PDFInfo
- Publication number
- EP3664767B1 EP3664767B1 EP18760179.4A EP18760179A EP3664767B1 EP 3664767 B1 EP3664767 B1 EP 3664767B1 EP 18760179 A EP18760179 A EP 18760179A EP 3664767 B1 EP3664767 B1 EP 3664767B1
- Authority
- EP
- European Patent Office
- Prior art keywords
- bottle
- coupling
- connector
- male
- adapter connector
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
- 239000012530 fluid Substances 0.000 title claims description 87
- 238000012546 transfer Methods 0.000 title description 86
- 230000008878 coupling Effects 0.000 claims description 197
- 238000010168 coupling process Methods 0.000 claims description 197
- 238000005859 coupling reaction Methods 0.000 claims description 197
- 230000002093 peripheral effect Effects 0.000 claims description 32
- 239000003814 drug Substances 0.000 claims description 20
- 238000007789 sealing Methods 0.000 claims description 15
- 230000002209 hydrophobic effect Effects 0.000 claims description 7
- 238000006073 displacement reaction Methods 0.000 claims description 6
- 230000007246 mechanism Effects 0.000 description 5
- 229940079593 drug Drugs 0.000 description 4
- 239000000463 material Substances 0.000 description 4
- 229920001296 polysiloxane Polymers 0.000 description 4
- 238000002483 medication Methods 0.000 description 3
- 238000004891 communication Methods 0.000 description 2
- 239000011159 matrix material Substances 0.000 description 2
- 230000007935 neutral effect Effects 0.000 description 2
- 230000007704 transition Effects 0.000 description 2
- VZSRBBMJRBPUNF-UHFFFAOYSA-N 2-(2,3-dihydro-1H-inden-2-ylamino)-N-[3-oxo-3-(2,4,6,7-tetrahydrotriazolo[4,5-c]pyridin-5-yl)propyl]pyrimidine-5-carboxamide Chemical compound C1C(CC2=CC=CC=C12)NC1=NC=C(C=N1)C(=O)NCCC(N1CC2=C(CC1)NN=N2)=O VZSRBBMJRBPUNF-UHFFFAOYSA-N 0.000 description 1
- 238000007792 addition Methods 0.000 description 1
- 239000011324 bead Substances 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 238000012217 deletion Methods 0.000 description 1
- 230000037430 deletion Effects 0.000 description 1
- 238000013461 design Methods 0.000 description 1
- 230000005489 elastic deformation Effects 0.000 description 1
- 210000004251 human milk Anatomy 0.000 description 1
- 235000020256 human milk Nutrition 0.000 description 1
- 238000003780 insertion Methods 0.000 description 1
- 230000037431 insertion Effects 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 239000012858 resilient material Substances 0.000 description 1
- 238000005549 size reduction Methods 0.000 description 1
- 239000013589 supplement Substances 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
- A61J7/0015—Devices specially adapted for taking medicines
- A61J7/0053—Syringes, pipettes or oral dispensers
Definitions
- 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.
- fluids such as medications, supplements, breast milk, formula, and the like.
- a syringe may be used to measure and transfer the fluid.
- 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.
- a plunger of the syringe can be retracted to withdraw fluids from the bottle to within the barrel of the syringe.
- 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.
- the remaining fluid within the bottle can range between about 0.50g to about 1.50g, for example between about 0.68g to about 1.12g according to some examples.
- the present invention provides a bottle adapter connector, as claimed in claim 1.
- the bottle adapter 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 includes a conduit extending therethrough.
- the male coupling includes a male ENFit compatible coupling.
- the male ENFit compatible coupling is configured for engagement with a female ENFit compatible coupling.
- the female ENFit compatible coupling includes a dosing control coupling for extension within a portion of the conduit of the male ENFit compatible coupling.
- the outer peripheral surface includes a plurality of laterally offset flanges for providing frictional engagement with an opening of a medicine bottle.
- the bottle adapter has a diameter of between about 12 - 28 millimeters.
- 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.
- the sealing mechanism includes a substantially resilient grommet having a first open end for receiving the male coupling and a substantially closed second end.
- the resilient grommet is formed from silicone.
- a cap can be tethered to the body of the bottle adapter.
- the base member is substantially flexible and elastically deformable such that the male coupling is movable in an axial direction.
- 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.
- 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.
- the first coupling may include a female enteral-only coupling.
- 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.
- the adapter may further include a closure tethered thereto.
- the lid may further include 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.
- the second coupling may include a lumen extending generally axially along the second axis.
- the second coupling may include a male ENFit compatible coupling.
- the lid mayfurther 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.
- 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 (57.15mm), the body comprising a first surface defining a first coupling and a second surface comprising a second coupling.
- a conduit may extend entirely through the couplings from the first end to the second end.
- the first coupling may be generally centrally-positioned on the body and extend towards the first end, and the second coupling may be generally axially aligned with the first coupling and extend towards the second end.
- the first coupling includes a male ENFit compatible coupling and the second coupling includes a male enteral-only coupling.
- the bottle adapter connector of the present invention is 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, wherein the sloped surface 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.
- the base portion includes a sloped surface extending towards the first end and up to the conduit of the male coupling.
- the male coupling includes a male ENFit compatible coupling.
- the male ENFit compatible coupling is configured for engagement with a female ENFit compatible coupling.
- 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.
- the outer peripheral surface includes a plurality of laterally offset flanges for providing frictional engagement with an opening or mouth of a medicine bottle.
- the cylindrical body of the bottle adapter connector includes a diameter of between about 12 - 28 millimeters.
- the connector further includes a shelf extending outwardly from the outer peripheral surface of the cylindrical body.
- 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.
- 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.
- 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.
- at least a portion of the sloped surface includes a texturized surface. In example embodiments, the texturized surface includes a hydrophobic or oleophobic surface.
- the bottle adapter connector is 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.
- the sloped surface 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.
- the sloped surface is angled between about 30-70 degrees relative to the extension of the cylindrical body.
- the male coupling comprises a male ENFit compatible coupling.
- the male ENFit compatible coupling is configured for engagement with a female ENFit compatible coupling.
- 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.
- at least a portion of the sloped surface includes a texturized, hydrophobic or oleophobic surface.
- Figures 1-34 show several examples of fluid transfer connectors and adapters for providing the transfer of fluid or medicine from a container or pharmacy bottle to a syringe S, or for example, from the syringe S to the bottle.
- the fluid transfer connectors and adapters of the present invention are configured for providing engagement between an end connector FC of a syringe S and a conventional enteral-only ported press-in bottle adapter, or for example, a stepped adapter comprising an enteral-only port.
- 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.
- the fluid transfer connectors can be sized as desired, for example, to accommodate coupling with containers or bottles of different sized openings.
- 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.
- any of the fluid transfer connectors as described herein can comprise both enteral-only and ENFit compatible connectors as desired.
- FIGS 1-4 show a bottle adapter connector 10 according to an example.
- the bottle adapter connector 10 comprises a cylindrical body 12 comprising an outer peripheral surface 13 that defines a plurality of outer peripheral flanges or steps 14.
- the flanges or steps 14 are preferably flexible, resilient and sized to engage with bottle openings of a desirable size.
- the bottle adapter connector 10 is in the form of a "press-in" adapter, for example, such that the flanges or steps 14 along the outer peripheral surface 13 generally frictionally engage the opening of a bottle, for example, the opening of a pharmacy or medicine bottle.
- commonly used bottles most frequently used in medicine practice range between about2-16 ounces (57 - 454 grams), and the opening thereof will generally vary according to its volume.
- the connector 10 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, between a diameter D 1 of about 10 - 40 millimeters, and between about 12 - 38 millimeters according to one example embodiment (see Figures 1 and 5 ).
- the bottle opening or inner diameter thereof is generally between about 12 - 33 millimeters.
- the flanges 14 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 a bottle or container.
- the flanges 14 are laterally offset and extend along the length or height H of the connector 10, for example, between the upper and lower surfaces of the body 15a, 15b.
- the flanges 14 are resilient and flexible such that the adapter connector 10 can engage a bottle opening having an inner diameter range of up to about 4- 5 millimeters difference with respect to the adapter connector diameter.
- the diameter D 1 of the connector 10 can be up to about 17 millimeters and still provide for fitting and sealing engagement with the bottle opening.
- 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.
- 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.
- 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.
- the male coupling 22 can comprise a male ENFit compatible coupling and the end coupling FC can comprise a female ENFit compatible coupling.
- 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 Figure 4 ).
- 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 Figure 4 ).
- U.S. Published Patent Application Serial No. 15/210,282 Patent Application Publication No. US 2016/0317393 , shows a syringe including a dosing control coupling.
- Figures 5-6 show a connector 100 according to another example.
- the connector 100 is generally similar to the connector 10 as described above and comprises an outer collar body comprising a plurality of outer peripheral flanges or steps 114, a recess portion 116 defined by a floor surface 120, a male coupling 122 centrally positioned and extending from the floor surface 120, and a central conduit 124 extending entirely through the male coupling 122.
- the male coupling 122 extends from the floor surface 120 a distance X above the upper surface 115a of the body 112 comprising the outer peripheral surface 113 having the flanges or steps 114.
- the distance X is generally between about 0.5 - 6 millimeters.
- closure of a lid or cap L atop the connector 100 causes engagement of a surface of the cap L with an end of the male coupling 122, for example, such that the male coupling 122 is generally axially displaced along axis Y within the recess portion 116.
- the floor surface 120 is preferably at least partially resilient and flexible to allow for axial displacement of the male coupling 122.
- the floor surface 120 undergoes at least some amount of elastic deformation between when the male coupling 122 is in its neutral state and when the cap L is fastened to the bottle to cause displacement of the male coupling 122.
- an end portion of the male coupling 122 is sealingly engaged with the surface of the cap L, for example, such that fluids or medicine within the bottle are prevented from passing through the conduit 124 when the cap L is coupled to the bottle.
- the cap L can comprise an anti-tamper or child-resistant lid.
- the end portion of the male coupling 122 can be configured as desired, for example, to be generally recessed below the upper portion of the collar body, or to be generally flush or planar with the end portion of the collar body.
- a one-way or two-way seal can be provided within at least a portion of the conduit 124, for example, to provide a seal within the conduit 124 when not in use and allow for functionality and transfer of the fluids during use.
- the seal is provided in the conduit rear an upper portion of the male coupling 122.
- the seal is provided in the conduit 124 near the floor surface 120. Further optional, the seal is provided in the conduit 124 between the ends of the male coupling 122.
- 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.
- 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.
- the floor surface 120 can be formed from a different material relative to the material forming the rest of the connector 100.
- 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.
- Figures 7-9 show a connector 200 according to another example embodiment of the present invention.
- the connector 200 is generally similar to the connectors 10, 100 as described above and comprising a body 12 comprising an outer peripheral surface 213 having a plurality of outer peripheral flanges or steps 214, a recess portion 216 defining a floor surface 220, a male coupling 222 centrally positioned and extending from the floor surface 220, and a central conduit 224 extending entirely through the male coupling 222.
- the connector 200 further comprises an outer collar 226 generally centrally positioned and surrounding the male coupling 222.
- a sealing mechanism 228 is preferably provided for substantially sealing the conduit 224 of the male coupling 222 from the elements, for example, by fitting itself around the male coupling 222 and within the outer collar 226.
- the seal mechanism comprises a substantially resilient grommet or sleeve 230 that is substantially cylindrical with a first open end for receiving the male coupling 222 and whereby the collar is fitted within a recessed portion defined between the outer collar 226 and the male coupling 222.
- the sleeve 230 comprises a second open end that is substantially closed except for a substantially small central opening 232, for example, which generally defines an opening sized between about 0.10-1.5 millimeters, for example about 0.50 millimeter according to one example embodiment.
- engagement of the end coupling FC of the syringe S with the male coupling 222 causes deformation of the sleeve 230, for example, such that the sleeve 230 is generally deformed and displaced within the recess so that fluid communication is provided between the end coupling FC and the male coupling 222 (e.g., the male coupling is received within the end coupling FC).
- the opening 232 is substantially flexible and elastic so that the entirety of the sleeve 230 passes beyond the end portion of the male coupling 222 to permit communication of the conduit 224 with the end coupling FC.
- Retraction of the end coupling FC preferably causes the sleeve 230 to expand back to its neutral state such that the sleeve substantially seals the conduit 224 from the elements.
- the sleeve 230 is formed from silicone or other resilient and substantially deformable materials (or combinations thereof). Accordingly, when the connector 200 is fitted within a bottle opening, the sleeve 230 preferably substantially seals the conduit 224 of the male coupling 222 such that the fluid or medicine within the bottle is not exposed to the elements.
- the end coupling FC is pressed atop the sleeve 230 such that the sleeve 230 deforms to retract therein to expose the male coupling 222 for engaging the end coupling FC.
- a portion of the cap e.g., internal surface
- Figures 10-13 show a connector 300 according to another example.
- the connector 300 is generally similar to the connectors 10, 100, 200 as described above and comprising a body 312 comprising an outer peripheral surface 313 having a plurality of outer peripheral flanges or steps 314, a recess portion 316 defining a floor 320, a male coupling 322 centrally positioned and extending from the floor 320, and a central conduit 324 extending entirely through the male coupling 222.
- the connector comprises a cap or closure 326 that is hingedly mounted to a portion of the connector 300 for pivoting between an open configuration (see Figure 12 ) and a closed configuration (see Figure 13 ) .
- the closure 326 comprises an outer collar 330, a central plug 322, and a tether 334 connecting the closure 326 to a portion of the connector 300.
- the tether 334 integrally couples the closure 326 to the connector 300.
- the tether can be removably coupled to the connector 300.
- the tether 334 extends outwardly from an upper portion of the body 12 near the outer peripheral flanges 314.
- the tether 334 comprises a living hinge such that the closure 326 coupled thereto is pivotable between the open and closed configurations.
- the living hinge is substantially flexible and resilient to permit the closure 326 to pivot at least about 180 degrees.
- 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.
- 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.
- the tether 334 (and hinge thereof) is generally configured to be about concentric with the outermost surfaces of the flanges 314.
- the tether and hinge can be sized as desired, for example, wherein in the closed position the hinge remains inwardly offset from the outermost surfaces of the flanges and does not engage with a surface of the bottle opening when engaged therewith.
- Figures 14-16 show a bottle adapter transfer connector 400 according to an example.
- the connector 400 provides for the transfer of fluids between a syringe S and a medicine bottle, for example wherein a stepped adapter SA is configured for engagement with the opening of the bottle and wherein the connector 400 removably couples to the connector 400 and facilitates the coupling engagement of the end connector FC of the syringe S therewith.
- the connector 400 comprises a cylindrical cap 412, a collar 414 generally extending perpendicularly from the cap 412, a male coupling 416 centrally-positioned and extending from the cap 412 in a first direction, and an engagement port 420 axially aligned with the male coupling 416 and extending in the second direction.
- a conduit extends entirely through the male coupling and engagement port, for example, such that fluids are permitted to flow therethrough.
- the engagement port 420 comprises a barbed feature 424, which preferably provides a surface feature capable of engagement with a port or conduit of the stepped adapter SA (see Figure 15 ).
- the collar 414 is preferably sized and shaped to be fitted around an upper outer periphery portion of the stepped adapter SA.
- the male coupling 416 comprises a male ENFit compatible coupling.
- the engagement port 420 is preferably sized to provide sufficient frictional engagement with the conduit of the stepped adapter SA.
- the conduit of the stepped adapter SA is generally sized to be compatible with a male enteral-only coupling.
- a closure 430 can be provided for sealing the conduit 422 from the elements.
- the closure 430 comprises an outer collar member 432, a central plug configured for frictional engagement with the conduit 422.
- 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.
- FIGS 17-18 show a transfer lid 500 according to another example.
- the transfer lid 500 is configured to be removably mounted to a bottle or container such that fluids or medicine contained within the container can be withdrawn or transferred therefrom and into a syringe S.
- the transfer lid 500 is compatible with multiple fittings or couplings, for example, both enteral-only connectors and ENFit compatible connectors.
- the transfer lid 500 comprises a generally circular top panel 510 with first and second transfer ports 512, 516 extending from the top panel 510 outwardly in a first or distal direction.
- the first transfer port 512 comprises a conduit 514 and the second transfer port 516 comprises a conduit 520.
- the first transfer port 512 comprises a male ENFit compatible connector and the second transfer port 516 comprises an enteral-only connector.
- 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.
- closures 540 are provided for sealing with the first and second transfer ports 512, 516.
- 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.
- a second closure 550 is provided for sealingly engaging the second transfer port 516.
- the second closure 550 comprises a flange or lip 552, a plug 554 and a tether 556.
- 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.
- Figures 19-20 show a transfer lid 600 according to another example.
- the transfer lid 600 is similarly configured to be removably mounted to a bottle or container such that fluids or medicine contained within the container can be withdrawn or transferred therefrom and into a syringe S.
- the transfer lid 500 is compatible with multiple fittings or couplings, for example, both enteral-only connectors and ENFit compatible connectors.
- the transfer lid 600 comprises a generally circular top panel 610 with a transfer port 612 extending from the top panel 610 outwardly in a first or distal direction.
- the transfer port 612 comprises a conduit 614 extending entirely through the transfer port 612.
- the transfer port 612 comprises an enteral-only connector, for example a female enteral-only connector.
- An attachment collar 616 extends in a second or proximal direction from the top panel 610, and an internal circumferential face thereof is threaded to releasably engage corresponding threads at the top of the containment shell of the container or bottle.
- An exterior circumferential face of the attachment collar 616 of the transfer lid 600 optionally comprises spaced intentions, ridges, recesses, or other gripping features 620 to assist a user in installing and removing the transfer lid 600 onto and from the containment shell of the container.
- An adapter 630 and a closure 642 can be provided with the transfer lid 600.
- 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.
- a tether generally connects the adapter 630 and closure 642 with the transfer lid 600.
- a first tether 652 is provided for connecting the transfer lid 600 with the adapter 630
- a second tether 654 is provided for connecting the adapter 630 with the closure 642.
- the transfer lid 600 can be fastened to a bottle for facilitating the transfer of fluids between the bottle and the syringe.
- the transfer port 612 can be utilized to facilitate the transfer of fluids therebetween.
- 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.
- the transfer lid 600 accommodates both enteral-only and ENFit compatible connectors.
- the present disclosure 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.
- 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.
- Figures 21-25 show a fluid transfer adapter 700 according to another example.
- the adapter 700 comprises a flange or disc-shaped body 710 comprising a first end 712 and a second end 714.
- the disc-shaped body 710 comprises a first surface 720 defining a first coupling 722 and a second surface 724 comprising a second coupling 726.
- a conduit 730 extends entirely through the couplings 722, 726 from the first end 712 to the second end 714.
- the first coupling 722 is generally centrally-positioned on the body and extends towards the first end 712, and the second coupling 726 is generally axially aligned with the first coupling 722 and extends towards the second end 714.
- the first coupling 722 comprises a male ENFit compatible coupling and the second coupling 726 comprises a male enteral-only coupling.
- the adapter 700 can preferably be used with both conventional "press-in" and stepped bottle adapters PA, SA.
- conventional bottle adapters generally comprise an enteral-only fitting
- the second coupling 726 is configured for engagement with the enteral-only fitting of the bottle adapters PA, SA
- the first coupling 722 is a male ENFit compatible coupling configured for providing engagement with an ENFit compatible coupling, for example, a female ENFit compatible coupling FC of a syringe S.
- the male ENFit compatible connector can be configured for a slip / friction fit connection, or can comprise one or more coupling elements for permanent / removable engagement with a portion of the female ENFit compatible connector of the syringe, for example, one or more ribs or threads of the female ENFit compatible connector.
- the male ENFit compatible connector can comprise other coupling or engagement features, for example, one or more flexible clips or other couplings such that permanent or removable engagement can be provided between the male ENFit connector and the female ENFit connector of the syringe.
- 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.
- the fluid transfer adapter including the flange has a minimum dimension of at least about 2.25 inches (5.72 cm) by at least about 1.25 inches (3.18 cm), or is otherwise sized and configured to prevent the fluid transfer adapter from passing through a 2.25 inches x 1.25 inches (5.72 cm x 3.18 cm) choke test cylinder in compliance with 37 C.F.R. 1501.4.
- the flange comprises a circular disc having a diameter D 2 of at least about 2.25 inches (5.72 cm), for example 2 1 ⁇ 2 inches (6.35 cm) or 3 inches (5.08 cm).
- 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 1 1 ⁇ 2 inches (3.81 cm), 4 inches (10.16 cm), etc.
- one or more openings can be formed within one or more portions of the body as desired.
- 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.
- 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.
- the disc-shaped body 710 is substantially uniform and comprises a substantially radiused outer periphery, for example, wherein a generally uniform radiused edge is defined between the upper and lower surfaces of the disc-shaped body, and wherein a substantially smooth transition is provided between the surfaces 720, 724.
- the outer diameter D 2 of the body 710 is at least about 2.25 inches
- a thickness T 1 that is defined between the upper and lower surfaces 720, 724 is between about 1-10 millimeters, for example between about 2-8 millimeters according to some examples.
- the thickness T 1 is about 2 millimeters.
- the thickness, at least of the outer periphery portion of the adapter can be more or less than 2 millimeters as desired.
- Figures 26-29 show a plurality of fluid transfer adapters 800, 900, 1000, 1100 according to additional examples.
- the outer periphery of each of the adapters 800, 900, 1000 and 1100 has been modified with respect to the substantially radiused outer periphery 732 of the adapter 700.
- the radiused outer periphery 832 further includes an outer rim extension 834 extending towards the second end 814, and thereby defining a recess 836 therein.
- the thickness T 2 is between about 3-5 millimeters.
- the recess 836 is sized for receiving the large coupling end of the stepped connector (see Figure 22 ).
- Figure 27 shows a similar adapter 900, for example, comprising an outer rim extension 934 and a recess 936.
- one or more openings 940 can be formed through the body 910.
- the thickness T 3 is between about 2 - 5 millimeters.
- the openings are generally cylindrical.
- the openings can be spaced along a radial and/or linear array, and can be sized and shaped as desired.
- a circular array of five generally cylindrical openings extend entirely through the body.
- 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.
- the body can define a plurality of openings, for example, an outer and inner array of circular openings.
- the outer array comprises about twelve openings and the inner array comprises about twelve openings.
- 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.
- the disc-shaped body can comprise a matrix of openings formed through at least a portion of the disc-shaped body.
- the disc-shaped body can comprise a matrix of square openings formed through the body.
- the openings can be shaped as desired.
- the openings provide for an enhanced gripping surface, for example, such that the body can be easily grasped by a user and manipulated.
- Figure 28 shows an adapter 1000 comprising an outer periphery having a T-shaped cross-sectional shape, for example comprising outer rim extensions 1034 extending oppositely therefrom towards their respective ends 1012, 1014.
- the thickness T 4 is between about 3 - 8 millimeters.
- Figure 29 shows an adapter 1100 according to another example.
- the body 1110 comprises a radiused outer periphery 1132 and recesses 1036.
- the radiused outer periphery 1132 protrudes at least partially above the first and second surfaces 1120, 1124 and defines a thickness T 5 of between about 1 - 4 millimeters.
- the at least partially raised radiused outer periphery 1132 provides a gripping feature.
- Figures 30-32 show a bottle adapter connector 1200 according to another example embodiment of the present invention.
- the bottle adapter connector 1200 is generally similar to the connector 10 as described above.
- the connector 1200 comprises a generally cylindrical body 1212 extending from a first end to a second end and defining an outer periphery 1213 that defines a plurality of outer peripheral flanges or steps 1214 and a flange or shelf 1216.
- the flanges or steps 1214 are preferably flexible, resilient and sized to engage with bottle openings of a desirable size.
- the bottle adapter connector 1200 is in the form of a "press-in" adapter, for example, such that the flanges or steps 1214 along the outer peripheral surface 1213 generally frictionally engage the opening of a bottle, for example, the mouth or opening of a pharmacy or medicine bottle (see Figure 32 ).
- the shelf 1216 extends outwardly from the outer peripheral surface 1213 of the cylindrical body 1212 generally near the first end, for example, to provide for seating engagement with an end portion of the bottle opening.
- the shelf 1216 prevents further insertion of the adapter 1200 within the bottle.
- the shelf 1216 is preferably sized and shaped so as to permit a cap or cover to remain connectable with the bottle opening, and wherein attachment of the cap with the bottle opening generally seals the shelf 1216 with the bottle opening.
- 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 D 1 of about 10 - 40 millimeters, and between about 12 - 38 millimeters according to one example embodiment (see Figure 31 ).
- the bottle opening or inner diameter thereof is generally between about 12 - 33 millimeters.
- the diameter D 1 of the cylindrical body is about 15 millimeters.
- the diameter D 1 is about 18 millimeters.
- 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.
- the flanges 1214 comprise a thickness T 1 and generally extend a length L 1 outwardly from the outer peripheral surface 1213, and the flanges 1214 are generally are laterally offset or spaced apart to define a length L 2 therebetween.
- the thickness T 1 is between about 0.125 - 1 millimeter, more preferably about 0.54 millimeters, the length L 1 is between about 1 - 4 millimeters, more preferably about 2.8 millimeters, and the length L 2 is between about 1.5 - 5 millimeters, more preferably about 3.41 millimeters according to one example embodiment.
- the shelf 1216 comprises a thickness T 2 and extends outwardly from the cylindrical body 1212 to define an outer diameter D 3 .
- the thickness T 2 is generally between about 0.35 -1.75 millimeters, for example, about 1 millimeter according to one example.
- the outer diameter D 3 is generally sized to be generally similar to the outer diameter of the opening of the bottle B (see Figure 32 ). According to one example, the outer diameter D 3 is generally between about 12 - 45 millimeters. According to one example, the outer diameter D 3 is about 21 millimeters. According to another example, the outer diameter D 3 is about 24 millimeters.
- 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.
- the cylindrical body comprises an inner diameter D 2 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.
- the inner diameter D 2 of the cylindrical body 1212 is between about 13 - 16.4 millimeters.
- a height H 1 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.
- an end portion of the male coupling 1222 generally extends a length L 4 beyond the lower surface of the shelf 1216 and the upper-most flange 1214 is generally offset a distance L 3 from the second end.
- the length L4 is between about 0.125 - 1.5 millimeters, more preferably about 1 millimeter according to one example embodiment
- the length L3 is between about 0.1 - 0.75 millimeters, more preferably about 0.354 millimeters according to one example embodiment.
- the male coupling 1222 is generally flush with the lower surface of the shelf 1216, or for example, at least partially recessed below the lower surface of the shelf 1216.
- 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 Figure 32 ).
- the syringe S can comprise a dosing control coupling or low dose tip LT, for example, which is compatible for fitting within the conduit 1224 when the end coupling FC is coupled with the male coupling 1222, and which preferably substantially if not entirely eliminates dosing inaccuracies (see Figure 4 ).
- U.S. Published Patent Application Serial No. 15/210,282 Patent Application Publication No. US 2016/0317393 , shows a syringe including a dosing control coupling.
- 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.
- the sloped surface 1230 is generally sloped inwardly to define an angle a.
- the angle a is generally between about 0.5 - 89.5 degrees, for example about 30 degrees according to one example embodiment.
- the sloped surface 1230 can be angled as desired.
- the angle a is about 24 degrees.
- the angle a is about 36 degrees.
- 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.
- 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 Figure 32 ).
- the fluid remaining within the bottle after attempting to withdrawal the entirety therefrom is about 0.014g, for example, which is between about 1 % - 20% of the fluid compared to the fluid remaining within the bottle when using known connectors.
- 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.
- any of the bottle connectors as depicted in Figures 1-13 can similarly comprise a sloped surface such that substantially all of the fluid within the bottle can be withdrawn, for example, such that substantially zero fluid is prevented from being withdrawn.
- the sloped surface can be a substantially linear surface, or for example, can be a stepped or non-linear sloped surface according to additional example embodiments of the present invention.
- the base portion 1226 comprises a sloped surface 1230 extending upwards and outwardly from the conduit 1224 of the male coupler 1222, and a generally tapered-off portion 1232 is defined at the upper-most portion of the base portion 1226, for example, which generally extends up to the outer peripheral surface 1213 of the cylindrical body 1212.
- a lead-in portion 1234 is defined at the second end to facilitate inserting the connector 1200 into the mouth of the bottle B.
- the lead-in portion 1234 preferably assists a user in properly aligning the second end of the connector 1200 with the mouth of the bottle B, for example, such that the connector 1200 can be easily inserted therein.
- the connector 1200 is fully inserted within the mouth of the bottle B, thereby causing the flanges 1214 to substantially flex and frictionally engages with the inner surface of the mouth of the bottle B.
- a stop surface 1217 of the shelf 1216 abuts with the end of the bottle opening.
- 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.
- 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.
- the entirety of the sloped surface and a surface of at least one of the flanges 1214 comprises a texturized surface finish 1240.
- the lead-in portion 1234 can comprise the surface finish 1240.
- the texturized surface finish comprises a texturized surface finish having a VDI range of between about 12 - 45.
- VDI values can be used as desired.
- the sloped surface of the base portion can generally extend along a substantially linear path from the conduit to the outer peripheral surface of the cylindrical body.
- the base portion 1326 comprises a sloped surface 1330 that extends along a substantially linear path from the conduit 1324 of the male coupling 1322 to an outer peripheral surface 1313 of the cylindrical body 1312.
- the sloped surface 1330 comprises one or more linear segments and/or one or more non-linear segments, both of which preferably provide a funnel-like feature so as to prevent most, if not all, fluids from remaining within the bottle B when it is desired to remove the entirety therefrom.
- the male coupling can optionally be in the form of a female coupling, for example, a female coupling similar to that of the syringe S, for example, such that a syringe comprising a male coupling can be connected therewith to provide for transferring fluids between the bottle B and the syringe S.
- the female coupling can further comprise a lumen extension tip, for example, as similarly described above and such that dosing inaccuracies are substantially minimized (if not entirely eliminated).
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Description
- 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 0.50g to about 1.50g, for example between about 0.68g to about 1.12g 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. Related art includes
WO 2007/100779 A2 which discloses a bottle adapter for receiving a needleless syringe, andEP 2921152 A1 which discloses a drug dispensing system. - Disclosed herein are devices such as 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 provides a bottle adapter connector, as claimed in
claim 1. The bottle adapter 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 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 examples, 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 examples, 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 examples, a cap can be tethered to the body of the bottle adapter. According to the invention, the base member is substantially flexible and elastically deformable such that the male coupling is movable in an axial direction. In examples, 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.
- Also disclosed herein is 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.
- The first coupling may include a female enteral-only coupling. 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. The adapter may further include a closure tethered thereto.
- The lid may further include 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. The second coupling may include a lumen extending generally axially along the second axis. The second coupling may include a male ENFit compatible coupling.
- The lid mayfurther 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.
- Also disclosed herein is 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 (57.15mm), the body comprising a first surface defining a first coupling and a second surface comprising a second coupling. A conduit may extend entirely through the couplings from the first end to the second end.
- The first coupling may be generally centrally-positioned on the body and extend towards the first end, and the second coupling may be generally axially aligned with the first coupling and extend towards the second end. The first coupling includes a male ENFit compatible coupling and the second coupling includes a male enteral-only coupling.
- The bottle adapter connector of the present invention is 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, wherein the sloped surface 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.
- 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 examples, 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 examples, 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 example embodiments, the bottle adapter connector is 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 sloped surface 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. As such, aspects, embodiments and examples of the present disclosure which do not fall under the scope of the appended claims do not form part of the invention and are merely provided for illustrative purposes.
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FIGURES 1 shows a bottle adapter connector according to an example. -
FIGURE 2 shows the bottle adapter connector ofFigure 1 comprising a syringe coupled to a male port of the bottle adapter connector. -
FIGURE 3 shows the bottle adapter ofFigure 2 and showing the end coupling of the syringe removed from engagement with the male port. -
FIGURE 4 shows the bottle adapter and end coupling of the syringe ofFigure 3 , and showing the end coupling of the syringe comprising a dosing control coupling and being compatible for fitting with the male port of the bottle adapter connector. -
FIGURES 5-6 show a sequence of operation of a bottle adapter connector comprising a flexible floor surface and showing that closing a cap atop the connector causes retraction of the male port and sealing engagement with an interior surface of the cap. -
FIGURE 7 shows a bottle adapter connector according to another example embodiment of the present invention, showing a silicone sleeve wrapped around the male port for engagement with the end coupling of the syringe. -
FIGURE 8 shows a cross-sectional view ofFigure 7 taken along line 8-8. -
FIGURE 9 shows the cross-sectional view ofFigure 8 , and showing the end coupling of the syringe engaging the male port such that the silicone sleeve is displaced to permit fluid flow between the syringe end coupling and the male coupling of the bottle adapter connector. -
FIGURE 10 shows a bottle adapter connector according to another example, and showing the bottle adapter comprising a tethered cap for engagement with a male port of the connector. -
FIGURE 11 shows a perspective view of a cross-sectional view of the connector ofFigure 10 . -
FIGURES 12-13 show a sequence of operation of the bottle adapter connector and tethered cap ofFigure 10 , and showing cap being generally hinged to the connector to be moved between an open configuration and a closed or capped configuration. -
FIGURE 14 shows a perspective view of a bottle adapter transfer connector according to another example, and showing a bottle adapter connector engaged with a portion of the bottle adapter transfer connector. -
FIGURE 15 shows a perspective cross-sectional view of the bottle adapter transfer connector coupled to a portion of the bottle adapter connector shown inFigure 14 . -
FIGURE 16 shows a cross-sectional view of the bottle adapter transfer connector ofFigure 15 . -
FIGURE 17 shows a perspective view of a fluid transfer lid according to another example. -
FIGURE 18 shows a rear perspective view of the fluid transfer lid ofFigure 17 . -
FIGURE 19 shows a perspective view of a fluid transfer lid according to another example. -
FIGURE 20 shows a rear perspective view of the fluid transfer lid ofFigure 19 . -
FIGURES 21-22 show a fluid transfer adapter according to another example, the fluid transfer adapter being compatible for removable engagement with both a conventional enteral-only ported press-in bottle adapter and an enteral-only stepped bottle adapter. -
FIGURE 23 shows a perspective view of a first side of the fluid transfer adapter ofFigures 21-22 . -
FIGURE 24 shows a second side of the fluid transfer adapter ofFigure 23 . -
FIGURE 25 shows a cross-sectional view of the fluid transfer adapter ofFigure 23 taken along line 25-25. -
FIGURE 26 shows a cross-sectional view of a fluid transfer adapter according to another example. -
FIGURE 27 shows a cross-sectional view of a fluid transfer adapter according to another example. -
FIGURE 28 shows a cross-sectional view of a fluid transfer adapter according to another example. -
FIGURE 29 shows a cross-sectional view of a fluid transfer adapter according to another example. -
FIGURE 30 shows a plan view of a bottle adapter connector according to another example embodiment of the present invention. -
FIGURE 31 shows a cross-sectional view of the bottle adapter connector ofFigure 30 taken along line 31-31. -
FIGURE 32 shows a cross-sectional view of the bottle adapter connector ofFigure 31 inserted within a mouth of a bottle and with a syringe connected to a coupling thereof. -
FIGURE 33 shows a perspective view of the bottle adapter connector ofFigure 31 , and showing a texturized surface being provided on at least a portion thereof. -
FIGURE 34 shows a cross-sectional view of a bottle adapter connector according to another example embodiment of the present invention. - 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.
- 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,
Figures 1-34 show several examples of fluid transfer connectors and adapters for providing the transfer of fluid or medicine from a container or pharmacy bottle to a syringe S, or for example, from the syringe S to the bottle. According to other examples, the fluid transfer connectors and adapters of the present invention are configured for providing engagement between an end connector FC of a syringe S and a conventional enteral-only ported press-in bottle adapter, or for example, a stepped adapter comprising an enteral-only port. - According to examples, 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. 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 examples, 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.
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Figures 1-4 show abottle adapter connector 10 according to an example. Thebottle adapter connector 10 comprises acylindrical body 12 comprising an outerperipheral surface 13 that defines a plurality of outer peripheral flanges or steps 14. In examples, the flanges orsteps 14 are preferably flexible, resilient and sized to engage with bottle openings of a desirable size. For example, thebottle adapter connector 10 is in the form of a "press-in" adapter, for example, such that the flanges orsteps 14 along the outerperipheral surface 13 generally frictionally engage the opening of a bottle, for example, the opening of a pharmacy or medicine bottle. In example forms, commonly used bottles most frequently used in medicine practice range between about2-16 ounces (57 - 454 grams), and the opening thereof will generally vary according to its volume. In examples, theconnector 10 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, between a diameter D1 of about 10 - 40 millimeters, and between about 12 - 38 millimeters according to one example embodiment (seeFigures 1 and5 ). In examples, the bottle opening or inner diameter thereof is generally between about 12 - 33 millimeters. In examples, theflanges 14 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 a bottle or container. In examples, theflanges 14 are laterally offset and extend along the length or height H of theconnector 10, for example, between the upper and lower surfaces of thebody flanges 14 are resilient and flexible such that theadapter connector 10 can engage a bottle opening having an inner diameter range of up to about 4- 5 millimeters difference with respect to the adapter connector diameter. For example, if the bottle opening inner diameter is about 12 millimeters, the diameter D1 of theconnector 10 can be up to about 17 millimeters and still provide for fitting and sealing engagement with the bottle opening. - In an example the
connector 10 comprises arecess 16 defined by an innerperipheral surface 18 of thebody 12, a base member orfloor 20, and a male coupling generally centrally-positioned on thefloor 20 and extending towards theupper surface 15a. Acentral conduit 24 extends entirely through themale coupling 22 along an elongate axis Y that is generally centrally-positioned in thefloor 20 and axially aligned with thebody 12. In examples, the end coupling FC of a syringe S is compatible for removable engagement with themale coupling 22, for example, such that the syringe can be coupled to theconnector 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. Themale coupling 22 can comprise a male ENFit compatible coupling and the end coupling FC can comprise a female ENFit compatible coupling. According to some examples, the syringe S can comprise a dosing control coupling or low dose tip LT, for example, which is compatible for fitting within theconduit 24 when the end coupling FC is coupled with themale coupling 22, and which preferably substantially if not entirely eliminates dosing inaccuracies (seeFigure 4 ).U.S. Published Patent Application Serial No. 15/210,282 , Patent Application Publication No.US 2016/0317393 , shows a syringe including a dosing control coupling. -
Figures 5-6 show aconnector 100 according to another example. Theconnector 100 is generally similar to theconnector 10 as described above and comprises an outer collar body comprising a plurality of outer peripheral flanges orsteps 114, arecess portion 116 defined by afloor surface 120, amale coupling 122 centrally positioned and extending from thefloor surface 120, and acentral conduit 124 extending entirely through themale coupling 122. According to examples, themale coupling 122 extends from the floor surface 120 a distance X above the upper surface 115a of thebody 112 comprising the outerperipheral surface 113 having the flanges or steps 114. In examples, the distance X is generally between about 0.5 - 6 millimeters. As depicted inFigure 6 , closure of a lid or cap L atop theconnector 100 causes engagement of a surface of the cap L with an end of themale coupling 122, for example, such that themale coupling 122 is generally axially displaced along axis Y within therecess portion 116. In examples, thefloor surface 120 is preferably at least partially resilient and flexible to allow for axial displacement of themale coupling 122. Thus, thefloor surface 120 undergoes at least some amount of elastic deformation between when themale coupling 122 is in its neutral state and when the cap L is fastened to the bottle to cause displacement of themale coupling 122. Preferably, by displacing the male coupling within therecess 116 when the cap L is coupled to the bottle, an end portion of themale coupling 122 is sealingly engaged with the surface of the cap L, for example, such that fluids or medicine within the bottle are prevented from passing through theconduit 124 when the cap L is coupled to the bottle. In examples, the cap L can comprise an anti-tamper or child-resistant lid. Alternatively, the end portion of themale coupling 122 can be configured as desired, for example, to be generally recessed below the upper portion of the collar body, or to be generally flush or planar with the end portion of the collar body. Optionally, a one-way or two-way seal can be provided within at least a portion of theconduit 124, for example, to provide a seal within theconduit 124 when not in use and allow for functionality and transfer of the fluids during use. In one example, the seal is provided in the conduit rear an upper portion of themale coupling 122. Optionally, the seal is provided in theconduit 124 near thefloor surface 120. Further optional, the seal is provided in theconduit 124 between the ends of themale coupling 122. - The
floor surface 120 can be configured to provide at least some amount of flexure or elasticity such that themale coupling 122 can axially move when engaged with the cap L. In some examples, thefloor surface 120 can be substantially thin relative to the other portions of theconnector 100, or can be formed from one or more flexible and resilient materials that allow for at least some displacement. According to one example, thefloor surface 120 can be formed from a different material relative to the material forming the rest of theconnector 100. For example, thefloor surface 120 can be co-molded or comprise a mixture of two or more materials such that thefloor surface 120 exhibits a greater amount of flexibility and elasticity compared to the other components or features of theconnector 100. -
Figures 7-9 show aconnector 200 according to another example embodiment of the present invention. In example embodiments, theconnector 200 is generally similar to theconnectors body 12 comprising an outerperipheral surface 213 having a plurality of outer peripheral flanges or steps 214, arecess portion 216 defining afloor surface 220, amale coupling 222 centrally positioned and extending from thefloor surface 220, and acentral conduit 224 extending entirely through themale coupling 222. In example embodiments, theconnector 200 further comprises anouter collar 226 generally centrally positioned and surrounding themale coupling 222. In example embodiments, asealing mechanism 228 is preferably provided for substantially sealing theconduit 224 of themale coupling 222 from the elements, for example, by fitting itself around themale coupling 222 and within theouter collar 226. In example embodiments, the seal mechanism comprises a substantially resilient grommet orsleeve 230 that is substantially cylindrical with a first open end for receiving themale coupling 222 and whereby the collar is fitted within a recessed portion defined between theouter collar 226 and themale coupling 222. In example embodiments, thesleeve 230 comprises a second open end that is substantially closed except for a substantially smallcentral opening 232, for example, which generally defines an opening sized between about 0.10-1.5 millimeters, for example about 0.50 millimeter according to one example embodiment. - As depicted in
Figures 8-9 , engagement of the end coupling FC of the syringe S with themale coupling 222 causes deformation of thesleeve 230, for example, such that thesleeve 230 is generally deformed and displaced within the recess so that fluid communication is provided between the end coupling FC and the male coupling 222 (e.g., the male coupling is received within the end coupling FC). As shown inFigure 9 , theopening 232 is substantially flexible and elastic so that the entirety of thesleeve 230 passes beyond the end portion of themale coupling 222 to permit communication of theconduit 224 with the end coupling FC. Retraction of the end coupling FC preferably causes thesleeve 230 to expand back to its neutral state such that the sleeve substantially seals theconduit 224 from the elements. In example embodiments, thesleeve 230 is formed from silicone or other resilient and substantially deformable materials (or combinations thereof). Accordingly, when theconnector 200 is fitted within a bottle opening, thesleeve 230 preferably substantially seals theconduit 224 of themale coupling 222 such that the fluid or medicine within the bottle is not exposed to the elements. And when it is desired to transfer fluids between the bottle and the syringe S, without any additional steps of removing a closure or other seal, the end coupling FC is pressed atop thesleeve 230 such that thesleeve 230 deforms to retract therein to expose themale coupling 222 for engaging the end coupling FC. Furthermore, when a cap L is coupled to the opening of the bottle with theconnector 200 fitted therein, a portion of the cap (e.g., internal surface) can engage with thesleeve 230 to apply a force thereon. -
Figures 10-13 show aconnector 300 according to another example. Theconnector 300 is generally similar to theconnectors body 312 comprising an outerperipheral surface 313 having a plurality of outer peripheral flanges orsteps 314, arecess portion 316 defining afloor 320, amale coupling 322 centrally positioned and extending from thefloor 320, and acentral conduit 324 extending entirely through themale coupling 222. According to examples, the connector comprises a cap orclosure 326 that is hingedly mounted to a portion of theconnector 300 for pivoting between an open configuration (seeFigure 12 ) and a closed configuration (seeFigure 13 ). In examples, theclosure 326 comprises anouter collar 330, acentral plug 322, and atether 334 connecting theclosure 326 to a portion of theconnector 300. Thetether 334 integrally couples theclosure 326 to theconnector 300. Optionally, the tether can be removably coupled to theconnector 300. - The
tether 334 extends outwardly from an upper portion of thebody 12 near the outerperipheral flanges 314. Preferably, thetether 334 comprises a living hinge such that theclosure 326 coupled thereto is pivotable between the open and closed configurations. In examples, the living hinge is substantially flexible and resilient to permit theclosure 326 to pivot at least about 180 degrees. In example embodiments, themale 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 theclosure 326 in the closed configuration and sealed with themale coupling 322. Thus, according to one example, theclosure 326, when sealingly engaged with themale coupling 322 and in the closed configuration (e.g., with thecentral plug 332 fitted within theconduit 324 and thecollar 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 inFigure 13 , the tether 334 (and hinge thereof) is generally configured to be about concentric with the outermost surfaces of theflanges 314. Optionally, the tether and hinge can be sized as desired, for example, wherein in the closed position the hinge remains inwardly offset from the outermost surfaces of the flanges and does not engage with a surface of the bottle opening when engaged therewith. -
Figures 14-16 show a bottleadapter transfer connector 400 according to an example. Theconnector 400 provides for the transfer of fluids between a syringe S and a medicine bottle, for example wherein a stepped adapter SA is configured for engagement with the opening of the bottle and wherein theconnector 400 removably couples to theconnector 400 and facilitates the coupling engagement of the end connector FC of the syringe S therewith. Theconnector 400 comprises acylindrical cap 412, acollar 414 generally extending perpendicularly from thecap 412, amale coupling 416 centrally-positioned and extending from thecap 412 in a first direction, and anengagement port 420 axially aligned with themale coupling 416 and extending in the second direction. In examples, a conduit extends entirely through the male coupling and engagement port, for example, such that fluids are permitted to flow therethrough. Theengagement port 420 comprises abarbed feature 424, which preferably provides a surface feature capable of engagement with a port or conduit of the stepped adapter SA (seeFigure 15 ). Thecollar 414 is preferably sized and shaped to be fitted around an upper outer periphery portion of the stepped adapter SA. In examples, themale coupling 416 comprises a male ENFit compatible coupling. In examples, theengagement port 420 is preferably sized to provide sufficient frictional engagement with the conduit of the stepped adapter SA. In examples, the conduit of the stepped adapter SA is generally sized to be compatible with a male enteral-only coupling. - In some examples, a
closure 430 can be provided for sealing theconduit 422 from the elements. Theclosure 430 comprises anouter collar member 432, a central plug configured for frictional engagement with theconduit 422. In example embodiments, theclosure 430 can be tethered to theconnector 400, for example whereintether 436 is generally flexible and resilient to allow for positioning theclosure 430 in either of the open or closed configurations. -
Figures 17-18 show atransfer lid 500 according to another example. Thetransfer lid 500 is configured to be removably mounted to a bottle or container such that fluids or medicine contained within the container can be withdrawn or transferred therefrom and into a syringe S. Preferably, thetransfer lid 500 is compatible with multiple fittings or couplings, for example, both enteral-only connectors and ENFit compatible connectors. Thetransfer lid 500 comprises a generally circulartop panel 510 with first andsecond transfer ports top panel 510 outwardly in a first or distal direction. Thefirst transfer port 512 comprises aconduit 514 and thesecond transfer port 516 comprises aconduit 520. Thefirst transfer port 512 comprises a male ENFit compatible connector and thesecond transfer port 516 comprises an enteral-only connector. - An
attachment collar 522 extends in a second or proximal direction from thetop 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 theattachment collar 522 of thetransfer lid 500 optionally comprises spaced intentions, ridges, recesses, or othergripping features 524 to assist a user in installing and removing thetransfer lid 500 onto and from the containment shell of the container. Optionally,closures 540 are provided for sealing with the first andsecond transfer ports first closure 542 comprising a flange orlip 544, a plug (unshown), an outer collar orlip 546, and atether 547. Similarly, asecond closure 550 is provided for sealingly engaging thesecond transfer port 516. Thesecond closure 550 comprises a flange orlip 552, aplug 554 and atether 556. Theclosures 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. -
Figures 19-20 show atransfer lid 600 according to another example. Thetransfer lid 600 is similarly configured to be removably mounted to a bottle or container such that fluids or medicine contained within the container can be withdrawn or transferred therefrom and into a syringe S. Preferably, thetransfer lid 500 is compatible with multiple fittings or couplings, for example, both enteral-only connectors and ENFit compatible connectors. Thetransfer lid 600 comprises a generally circulartop panel 610 with atransfer port 612 extending from thetop panel 610 outwardly in a first or distal direction. Thetransfer port 612 comprises aconduit 614 extending entirely through thetransfer port 612. Thetransfer port 612 comprises an enteral-only connector, for example a female enteral-only connector. Anattachment collar 616 extends in a second or proximal direction from thetop panel 610, and an internal circumferential face thereof is threaded to releasably engage corresponding threads at the top of the containment shell of the container or bottle. An exterior circumferential face of theattachment collar 616 of thetransfer lid 600 optionally comprises spaced intentions, ridges, recesses, or othergripping features 620 to assist a user in installing and removing thetransfer lid 600 onto and from the containment shell of the container. - An
adapter 630 and aclosure 642 can be provided with thetransfer lid 600. For example, theadapter 630 comprises acentral flange member 632, afirst connector 634, asecond connector 636, and aconduit 640 extending entirely through theconnectors closure 642 comprises a flange orlip 644, aplug 646, and an outer collar orlip 650. A tether generally connects theadapter 630 andclosure 642 with thetransfer lid 600. For example, afirst tether 652 is provided for connecting thetransfer lid 600 with theadapter 630, and asecond tether 654 is provided for connecting theadapter 630 with theclosure 642. In use, thetransfer 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, thetransfer port 612 can be utilized to facilitate the transfer of fluids therebetween. If the syringe S comprises a ENFit compatible coupling, theadapter 630 is connected with thetransfer port 612, for example, such that thefirst connector 634 is coupled with thetransfer port 612 and thesecond connector 636 is coupled with the ENFit compatible coupling of the syringe. - Accordingly, by the tethered
adapter 630, thetransfer lid 600 accommodates both enteral-only and ENFit compatible connectors. Accordingly, according to one example, the present disclosure 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, thetransfer lids -
Figures 21-25 show afluid transfer adapter 700 according to another example. As depicted, theadapter 700 comprises a flange or disc-shapedbody 710 comprising afirst end 712 and asecond end 714. The disc-shapedbody 710 comprises afirst surface 720 defining afirst coupling 722 and asecond surface 724 comprising asecond coupling 726. Aconduit 730 extends entirely through thecouplings first end 712 to thesecond end 714. Thefirst coupling 722 is generally centrally-positioned on the body and extends towards thefirst end 712, and thesecond coupling 726 is generally axially aligned with thefirst coupling 722 and extends towards thesecond end 714. Thefirst coupling 722 comprises a male ENFit compatible coupling and thesecond coupling 726 comprises a male enteral-only coupling. - As shown in
Figures 21-22 , theadapter 700 can preferably be used with both conventional "press-in" and stepped bottle adapters PA, SA. For example, as conventional bottle adapters generally comprise an enteral-only fitting, thesecond coupling 726 is configured for engagement with the enteral-only fitting of the bottle adapters PA, SA, while thefirst coupling 722 is a male ENFit compatible coupling configured for providing engagement with an ENFit compatible coupling, for example, a female ENFit compatible coupling FC of a syringe S. In example forms, the male ENFit compatible connector can be configured for a slip / friction fit connection, or can comprise one or more coupling elements for permanent / removable engagement with a portion of the female ENFit compatible connector of the syringe, for example, one or more ribs or threads of the female ENFit compatible connector. In alternate examples, the male ENFit compatible connector can comprise other coupling or engagement features, for example, one or more flexible clips or other couplings such that permanent or removable engagement can be provided between the male ENFit connector and the female ENFit connector of the syringe. - For example, 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. The fluid transfer adapter including the flange has a minimum dimension of at least about 2.25 inches (5.72 cm) by at least about 1.25 inches (3.18 cm), or is otherwise sized and configured to prevent the fluid transfer adapter from passing through a 2.25 inches x 1.25 inches (5.72 cm x 3.18 cm) choke test cylinder in compliance with 37 C.F.R. 1501.4. According to one example, the flange comprises a circular disc having a diameter D2 of at least about 2.25 inches (5.72 cm), for example 2 ½ inches (6.35 cm) or 3 inches (5.08 cm). In alternate examples, 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 1 ½ inches (3.81 cm), 4 inches (10.16 cm), etc. Optionally, one or more openings can be formed within one or more portions of the body as desired. 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, 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
Figure 25 , the disc-shapedbody 710 is substantially uniform and comprises a substantially radiused outer periphery, for example, wherein a generally uniform radiused edge is defined between the upper and lower surfaces of the disc-shaped body, and wherein a substantially smooth transition is provided between thesurfaces body 710 is at least about 2.25 inches, and a thickness T1 that is defined between the upper andlower surfaces -
Figures 26-29 show a plurality offluid transfer adapters adapters outer periphery 732 of theadapter 700. As depicted inFigure 26 , the radiusedouter periphery 832 further includes anouter rim extension 834 extending towards thesecond end 814, and thereby defining arecess 836 therein. The thickness T2 is between about 3-5 millimeters. According to one example form, therecess 836 is sized for receiving the large coupling end of the stepped connector (seeFigure 22 ).Figure 27 shows asimilar adapter 900, for example, comprising an outer rim extension 934 and arecess 936. According to one example, one ormore openings 940 can be formed through thebody 910. The thickness T3 is between about 2 - 5 millimeters. According to one example, the openings are generally cylindrical. Optionally, the openings can be spaced along a radial and/or linear array, and can be sized and shaped as desired. - According to one example, a circular array of five generally cylindrical openings extend entirely through the body. 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, the body can define a plurality of openings, for example, an outer and inner array of circular openings. According to examples, the outer array comprises about twelve openings and the inner array comprises about twelve openings. 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 examples, 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 examples, the openings provide for an enhanced gripping surface, for example, such that the body can be easily grasped by a user and manipulated.
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Figure 28 shows anadapter 1000 comprising an outer periphery having a T-shaped cross-sectional shape, for example comprisingouter rim extensions 1034 extending oppositely therefrom towards theirrespective ends Figure 29 shows anadapter 1100 according to another example. As depicted, thebody 1110 comprises a radiusedouter periphery 1132 and recesses 1036. According to one example, the radiusedouter periphery 1132 protrudes at least partially above the first andsecond surfaces outer periphery 1132 provides a gripping feature. -
Figures 30-32 show abottle adapter connector 1200 according to another example embodiment of the present invention. In example embodiments, thebottle adapter connector 1200 is generally similar to theconnector 10 as described above. In example embodiments, theconnector 1200 comprises a generallycylindrical body 1212 extending from a first end to a second end and defining anouter periphery 1213 that defines a plurality of outer peripheral flanges orsteps 1214 and a flange orshelf 1216. In example embodiments, the flanges orsteps 1214 are preferably flexible, resilient and sized to engage with bottle openings of a desirable size. For example, according to example embodiments, thebottle adapter connector 1200 is in the form of a "press-in" adapter, for example, such that the flanges orsteps 1214 along the outerperipheral surface 1213 generally frictionally engage the opening of a bottle, for example, the mouth or opening of a pharmacy or medicine bottle (seeFigure 32 ). Theshelf 1216 extends outwardly from the outerperipheral surface 1213 of thecylindrical body 1212 generally near the first end, for example, to provide for seating engagement with an end portion of the bottle opening. Thus, theshelf 1216 prevents further insertion of theadapter 1200 within the bottle. Further, theshelf 1216 is preferably sized and shaped so as to permit a cap or cover to remain connectable with the bottle opening, and wherein attachment of the cap with the bottle opening generally seals theshelf 1216 with the bottle opening. - In examples and as described above, commonly used bottles most frequently used in medicine practice range between about 2 - 16 ounces (57 - 454 grams), 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 (seeFigure 31 ). In examples, the bottle opening or inner diameter thereof is generally between about 12 - 33 millimeters. For example, the diameter D1 of the cylindrical body is about 15 millimeters. According to another example embodiment, the diameter D1 is about 18 millimeters. - In some examples, 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 some examples, theflanges 1214 comprise a thickness T1 and generally extend a length L1 outwardly from the outerperipheral surface 1213, and theflanges 1214 are generally are laterally offset or spaced apart to define a length L2 therebetween. According to examples, the thickness T1 is between about 0.125 - 1 millimeter, more preferably about 0.54 millimeters, the length L1 is between about 1 - 4 millimeters, more preferably about 2.8 millimeters, 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, theshelf 1216 comprises a thickness T2 and extends outwardly from thecylindrical 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. The outer diameter D3 is generally sized to be generally similar to the outer diameter of the opening of the bottle B (seeFigure 32 ). According to one example, the outer diameter D3 is generally between about 12 - 45 millimeters. According to one example, the outer diameter D3 is about 21 millimeters. According to another example, the outer diameter D3 is about 24 millimeters. - In example embodiments, the
adapter 1200 comprises anannular recess 1220 defined by an innerperipheral surface 1221 of thecylindrical body 1212, a base member orfloor 1226, and amale coupling 1222 generally centrally-positioned on thefloor 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 thecylindrical body 1212 is between about 13 - 16.4 millimeters. A height H1 is defined between a lower surface of theshelf 1216 and an upper surface of theupper-most flange 1214, for example, which generally defines the entire length or extension of theconnector 1200. However, as depicted inFigure 31 , an end portion of themale coupling 1222 generally extends a length L4 beyond the lower surface of theshelf 1216 and theupper-most flange 1214 is generally offset a distance L3 from the second end. In example embodiments, the length L4 is between about 0.125 - 1.5 millimeters, more preferably about 1 millimeter according to one example embodiment, and the length L3 is between about 0.1 - 0.75 millimeters, more preferably about 0.354 millimeters according to one example embodiment. According to alternate example embodiments, themale coupling 1222 is generally flush with the lower surface of theshelf 1216, or for example, at least partially recessed below the lower surface of theshelf 1216. - 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 ofFigure 32 ). 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 theconduit 1224 when the end coupling FC is coupled with themale coupling 1222, and which preferably substantially if not entirely eliminates dosing inaccuracies (seeFigure 4 ).U.S. Published Patent Application Serial No. 15/210,282 , Patent Application Publication No.US 2016/0317393 , shows a syringe including a dosing control coupling. - In example embodiments, the
base portion 1226 of the connector 1200 (e.g., furthest most portion inserted within the bottle opening) comprises a slopedsurface 1230 that generally extends from the outerperipheral surface 1213 of thecylindrical body 1212 to thelumen 1224 of themale port 1222. In example embodiments, the slopedsurface 1230 is generally sloped inwardly to define an angle a. In example embodiments, the angle a is generally between about 0.5 - 89.5 degrees, for example about 30 degrees according to one example embodiment. Optionally, the slopedsurface 1230 can be angled as desired. For example, according to one preferred embodiment, the angle a is about 24 degrees. According to another preferred embodiment, the angle a is about 36 degrees. In example embodiments, thesurface 1230 is generally funneled inwardly towards thelumen 1224 such that a substantial amount, if not all, of the fluid within the bottle, is directed to flow within thelumen 1224 and further into the female connector FC of the syringe S. Thus, theconnector 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 thelumen 1224 of theconnector 1200, and within the syringe S (seeFigure 32 ). - According to one example embodiment, the fluid remaining within the bottle after attempting to withdrawal the entirety therefrom is about 0.014g, 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 examples, any of the bottle connectors as depicted inFigures 1-13 can similarly comprise a sloped surface such that substantially all of the fluid within the bottle can be withdrawn, for example, such that substantially zero fluid is prevented from being withdrawn. According to one example, the sloped surface can be a substantially linear surface, or for example, can be a stepped or non-linear sloped surface according to additional example embodiments of the present invention. - According to some example embodiments and with reference to
Figure 31 , thebase portion 1226 comprises a slopedsurface 1230 extending upwards and outwardly from theconduit 1224 of themale coupler 1222, and a generally tapered-offportion 1232 is defined at the upper-most portion of thebase portion 1226, for example, which generally extends up to the outerperipheral surface 1213 of thecylindrical body 1212. According to example embodiments, a lead-inportion 1234 is defined at the second end to facilitate inserting theconnector 1200 into the mouth of the bottle B. Thus, in example embodiments, the lead-inportion 1234 preferably assists a user in properly aligning the second end of theconnector 1200 with the mouth of the bottle B, for example, such that theconnector 1200 can be easily inserted therein. - As depicted in
Figure 32 , theconnector 1200 is fully inserted within the mouth of the bottle B, thereby causing theflanges 1214 to substantially flex and frictionally engages with the inner surface of the mouth of the bottle B. In example embodiments, when theconnector 1200 is fully inserted within the mouth of the bottle B, astop surface 1217 of theshelf 1216 abuts with the end of the bottle opening. - According to another example, 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 inFigure 33 , the entirety of the sloped surface and a surface of at least one of theflanges 1214 comprises a texturizedsurface finish 1240. Optionally, the lead-inportion 1234 can comprise thesurface finish 1240. As such, when transferring fluids from the bottle B, through theconduit 1224 and within the syringe S, the fluid's reaction to the nonpolar boundary causes formation of droplets such that the fluid molecules are incapable of a size reduction that would be capable of remaining trapped within the bottle B or near one or more portions of the slopedsurface 1230, the lead-in portion 1234 (or one or more other portions of the connector 1200). According to one example, the texturized surface finish comprises a texturized surface finish having a VDI range of between about 12 - 45. Optionally, other VDI values can be used as desired. - According to yet another example, 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 inFigure 34 , thebase portion 1326 comprises a slopedsurface 1330 that extends along a substantially linear path from theconduit 1324 of themale coupling 1322 to an outerperipheral surface 1313 of thecylindrical body 1312. In other example embodiments, the slopedsurface 1330 comprises one or more linear segments and/or one or more non-linear segments, both of which preferably provide a funnel-like feature so as to prevent most, if not all, fluids from remaining within the bottle B when it is desired to remove the entirety therefrom. In alternate examples, the male coupling can optionally be in the form of a female coupling, for example, a female coupling similar to that of the syringe S, for example, such that a syringe comprising a male coupling can be connected therewith to provide for transferring fluids between the bottle B and the syringe S. In some examples, with the female coupling being provided with the connector (e.g., replacing the male coupling), the female coupling can further comprise a lumen extension tip, for example, as similarly described above and such that dosing inaccuracies are substantially minimized (if not entirely eliminated). - 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.
Claims (15)
- A bottle adapter connector (1200) comprising:a generally cylindrical body (1212) extending between a first end and a second end, and comprising an outer peripheral surface (1213) and an inner peripheral surface (1221); anda recess (1220) defined by the inner peripheral surface (1221) of the body (1212) and accessible from the first end, a base portion (1226) positioned at the second end, and a male coupling (1222) generally centrally positioned on the base portion (1226) and projecting towards the first end, the male coupling (1222) comprising a conduit (1224) extending therethrough,wherein the base portion (1226) comprises a sloped surface (1230) extending towards the first end and up to the conduit (1224) of the male coupling (1222);wherein the base portion (1226) is at least partially resilient and flexible to allow for axial displacement of the male coupling (1222), such that closure of a cap atop the connector (1200) causes axial displacement of the male coupling (1222) and sealing of the conduit (1224) of the male coupling (1222) with the cap.
- The bottle adapter connector (1200) of Claim 1, wherein the male coupling comprises (1222) a male ENFit compatible coupling.
- The bottle adapter connector (1200) of Claim 2, wherein the male ENFit compatible coupling is configured for engagement with a female ENFit compatible coupling;
preferably wherein the female ENFit compatible coupling further comprises a dosing control coupling for extension within a portion of the conduit of the male ENFit compatible coupling. - The bottle adapter connector (1200) of Claim 1, wherein the outer peripheral surface (1213) comprises a plurality of laterally offset flanges (1214) for providing frictional engagement with an opening or mouth of a medicine bottle;
preferably wherein the cylindrical body (1212) of the bottle adapter connector (1200) comprises a diameter of between about 12 - 28 millimeters. - The bottle adapter connector (1200) of Claim 1, further comprising a shelf (1216) extending outwardly from the outer peripheral surface (1213) of the cylindrical body (1212).
- The bottle adapter connector (1200) of Claim 1, wherein the sloped surface (1230) is angled between about 0.5 - 89.5 degrees relative to the extension of the cylindrical body (1212);
preferably wherein the sloped surface (1230) is angled between about 30 - 70 degrees relative to the extension of the cylindrical body (1212). - The bottle adapter connector (1200) of Claim 5, wherein a surface of the shelf (1216) 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.
- The bottle adapter connector (1200) of Claim 1, further comprising a lead-in portion (1234) defined at the second end.
- The bottle adapter connector (1200) of Claim 1, wherein the male coupling (1222) extends beyond an end of the body (1212) such that closure of a cap atop the connector (1200) causes the conduit (1224) of the male coupling (1222) to be sealed with the cap.
- The bottle adapter connector (1200) of Claim 1, wherein at least a portion of the sloped surface (1230) comprises a texturized surface;
preferably wherein the texturized surface comprises a hydrophobic or oleophobic surface. - The bottle adapter connector (1200) of claim 1, wherein the bottle adaptor connector is 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 (1200);
wherein the sloped surface (1230) is sloped inwardly towards the conduit (1224) such that a substantial amount, if not all, of the fluid within the bottle, is directed to flow within the conduit (1224) and further into the syringe when it is desired to withdraw fluids from the bottle. - The bottle adapter connector (1200) of Claim 11, wherein the sloped surface (1230) is angled between about 30 - 70 degrees relative to the cylindrical body (1212).
- The bottle adapter connector (1200) of Claim 11, wherein the male coupling (1222) comprises a male ENFit compatible coupling.
- The bottle adapter connector (1200) of Claim 13, wherein the male ENFit compatible coupling is configured for engagement with a female ENFit compatible coupling;
preferably wherein the female ENFit compatible coupling further comprises a dosing control coupling for extension within a portion of the conduit of the male ENFit compatible coupling. - The bottle adapter connector (1200) of Claim 11, wherein at least a portion of the sloped surface (1230) comprises a texturized, hydrophobic or oleophobic surface.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201762544167P | 2017-08-11 | 2017-08-11 | |
PCT/US2018/046235 WO2019032974A1 (en) | 2017-08-11 | 2018-08-10 | Fluid transfer connector |
Publications (2)
Publication Number | Publication Date |
---|---|
EP3664767A1 EP3664767A1 (en) | 2020-06-17 |
EP3664767B1 true EP3664767B1 (en) | 2021-09-22 |
Family
ID=63405441
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP18760179.4A Active EP3664767B1 (en) | 2017-08-11 | 2018-08-10 | Fluid transfer connector |
Country Status (5)
Country | Link |
---|---|
EP (1) | EP3664767B1 (en) |
JP (1) | JP2020530334A (en) |
AU (1) | AU2018313965A1 (en) |
MX (1) | MX2020000896A (en) |
WO (1) | WO2019032974A1 (en) |
Family Cites Families (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20080015539A1 (en) * | 2006-02-28 | 2008-01-17 | Robert Pieroni | Bottle with adapter for receiving needleless syringe |
DE102010031240A1 (en) * | 2010-07-12 | 2012-01-12 | Hamilton Bonaduz Ag | Pipette tip with hydrophobic surface formation |
MX2012013347A (en) * | 2012-11-16 | 2013-10-08 | Leopoldo Meneses Fernandez | System for dispensing drugs. |
AU2016294538B2 (en) * | 2015-07-14 | 2020-04-02 | Neomed, Inc. | Dosing control coupling for enteral fluid transfer |
-
2018
- 2018-08-10 EP EP18760179.4A patent/EP3664767B1/en active Active
- 2018-08-10 AU AU2018313965A patent/AU2018313965A1/en not_active Abandoned
- 2018-08-10 WO PCT/US2018/046235 patent/WO2019032974A1/en unknown
- 2018-08-10 MX MX2020000896A patent/MX2020000896A/en unknown
- 2018-08-10 JP JP2020506867A patent/JP2020530334A/en active Pending
Also Published As
Publication number | Publication date |
---|---|
JP2020530334A (en) | 2020-10-22 |
MX2020000896A (en) | 2020-09-10 |
WO2019032974A1 (en) | 2019-02-14 |
EP3664767A1 (en) | 2020-06-17 |
AU2018313965A1 (en) | 2020-02-06 |
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