CROSS-REFERENCE TO RELATED APPLICATIONSThe present invention claims priority to U.S. Provisional Patent Application Ser. No. 61/563,923 filed Nov. 28, 2011 and is a continuation-in-part of U.S. Non-Provisional patent application Ser. No. 13/191,721 filed Jul. 27, 2011, the entireties of which are incorporated herein by reference.
TECHNICAL FIELDThe present invention relates generally to the field of collection and dispensing of fluids, and more particularly to a collection and dispensing system for biological fluids, such as breast milk and/or dietary or medicinal materials.
BACKGROUNDMaintaining aseptic integrity is of great importance in many fluid collection and dispensing applications. For example, in the delivery of breast milk or formula to premature infants who are unable to feed regularly, freshness and prevention of contamination are critical. The delivery of enteral fluids is often controlled by regulations and medical standards of practice.
In addition to proper collection and dispensing of biological fluids, such as breast milk or formula, it is also desirable to provide for the containment, mixing and delivery of pharmaceutical or nutritional supplements. Various consumer and/or professional applications would benefit from improved systems and methods for fluid collection and delivery.
It is to the provision of improved systems and methods for fluid collection and delivery that the present invention is primarily directed.
SUMMARYIn example embodiments, the present invention provides a container for collecting, storing and dispensing fluid. The container includes a hollow tube configured to receive a plunger.
In a first example, the present invention comprises a self-venting enteral syringe which includes a syringe body having an outside surface and defining a hollow internal cavity therein, the syringe body including an open end and a substantially closed end opposite the open end, the substantially closed end being integrally formed with the remainder of the syringe body. At least one vent extends from the hollow cavity to the outside surface of the syringe body and a plunger is operable to selectively travel within the hollow cavity. A port is positioned adjacent the substantially closed end.
In example forms, the vent is separate from the port and extends from generally adjacent the substantially closed end to outside the syringe body. Optionally, the vent can comprise two vents including a first vent separate from the port and extending from generally adjacent the substantially closed end to outside the syringe body and a second vent formed in the port. Also optionally, the port can comprise a double-lumen seal such that a supply/discharge lumen and vent lumen can be extended into the double-lumen port seal. In one example form, the vent is formed in or adjacent the port.
Optionally, a removable cap can be provided for covering and uncovering the substantially closed end of the syringe body. However, preferably the integrally-formed, substantially closed end functions as a non-removable cap.
Optionally, an offset tip is formed or located in the substantially closed end of the syringe body, the offset tip being positioned in a location offset from a center of the substantially closed end of the syringe body.
Advantageously, the vent(s) improve the filling of the syringe, while the integral cap provides a better, simpler closure at that end (and makes a separate cap/lid unneeded in most instances). The offset tip helps provide better control in the filling and dispensing and is particularly helpful in maintaining uniformity in dispensing from the syringe. The optional double-lumen port seal can provide convenient filling/dispensing, while also providing a useful vent. Also, by utilizing the optional female port, a male-to-male connection can improve safety.
In another example form, the present invention comprises a self-venting enteral syringe including a syringe body having an outside surface and defining a hollow internal cavity therein and at least one vent extending from the hollow cavity to the outside surface of the syringe body. The syringe body includes an open end and a substantially closed end opposite the open end, with the substantially closed end being integrally formed with the remainder of the syringe body. A plunger is operable to selectively travel within the hollow cavity, while a port is formed in or adjacent the substantially closed end. A vent is positioned in or adjacent the port.
In another example form the present invention is a luer-tip-restricting apparatus for use with liquid transfer equipment. The luer-tip-restricting apparatus includes a female port assembly with a hollow body and with a top opening edge, a bottom opening edge and a tapering inner diameter. The tapering inner diameter is designed to prevent formation of an air-tight fit with a luer tip. The luer-tip restricting apparatus also has at least one stop protruding from the tapering inner diameter. The at least one stop is positioned within the tapering inner diameter to prevent an air-tight fit with a luer tip inserted into the top opening edge of the female port assembly.
In another example form, the present invention is a cap for use with a syringe bottle having a conical lid, a female barrel-shaped port assembly and a generally continuous circumferential groove. The cap includes a top planar surface with an elliptical shape with a major axis and a minor axis. The major axis is longer than the minor axis. The cap includes a generally continuous collar extending from the edge of the top planar surface to a distal edge. The collar is constructed of resiliently flexible material. The cap includes a pair of opposing grips protruding inwardly from the generally continuous collar. The grips are configured to be removably inserted within the syringe bottle circumferential groove. The cap includes a plug that extends from the top planar surface within the generally continuous collar dimensions. The plug is designed to removably insert into the syringe bottle port assembly.
In another example form, the present invention is an adaptor for use with a syringe bottle having a conical lid, a female barrel-shaped port assembly and a generally continuous circumferential groove. The adaptor includes a resiliently flexible elliptical collar with a major axis and a minor axis. The adaptor includes a funnel with a sloping surface and an elongated port with a distal end. The funnel extends within the dimensions of the major axis and the minor axis. The adaptor includes a pair of opposing grips protruding inwardly from the elliptical collar and configured to be removably inserted within the syringe bottle circumferential groove.
These and other aspects, features and advantages 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.
BRIEF DESCRIPTION OF THE DRAWINGSFIG. 1A is a side elevation view of a self-venting enteral syringe according to a first example embodiment of the present invention.
FIG. 1B is a sectional view of an optional removable cap portion of the syringe ofFIG. 1A.
FIG. 1C is a sectional view of the self-venting enteral syringe ofFIG. 1A.
FIG. 10 is an accessory port assembly according to an example embodiment of the present invention.
FIG. 2A is a side elevation view of a self-venting enteral syringe according to another example embodiment of the present invention.
FIG. 2B is a sectional view of a removable cap according to another example embodiment of the present invention.
FIG. 2C is a sectional view of the self-venting enteral syringe ofFIG. 2A.
FIG. 2D is a sectional view of an accessory port assembly according to another example embodiment of the present invention.
FIG. 2E is a plan view of a double-lumen seal portion of the self-venting syringe ofFIG. 2A.
FIG. 2F is a plan view of an alternate version of a double-lumen seal according to another example embodiment of the present invention.
FIG. 2G is a plan view of yet a further double-lumen seal.
FIG. 3 is a first perspective view of a luer-restricting syringe according to another example embodiment of the present invention.
FIG. 4 is a second perspective view of the luer-restricting syringe ofFIG. 3.
FIG. 5A is a cross-sectional view of the luer-restricting syringe ofFIG. 3.
FIG. 5B is a cross-sectional view of the luer-restricting syringe ofFIG. 3 in use with an enter-only syringe.
FIG. 5C is a cross-sectional view of the luer-restricting syringe ofFIG. 3 in use with a commercially-available luer slip tip.
FIG. 6 is a perspective view of a chimney insert and seal attachment used with the luer-restricting syringe ofFIG. 3.
FIG. 7 is a perspective cross-sectional view of the chimney insert and seal attachment ofFIG. 6.
FIG. 8 is a perspective view of the chimney insert ofFIG. 6 without the seal attachment.
FIG. 9 is a perspective view of the seal attachment ofFIG. 6 removed from the chimney insert.
FIG. 10 is an enlarged sectional view of the view ofFIG. 7.
FIG. 11 is a perspective view of a cap secured to the luer-restricting syringe according to another example embodiment of the present invention.
FIG. 12 is a top view of the cap ofFIG. 11.
FIG. 13 is a bottom view of the cap ofFIG. 11.
FIG. 14 is a perspective cut-away view of the cap ofFIG. 11.
FIG. 15A is a perspective cross-sectional view of the cap ofFIG. 11 secured to the luer-restricting syringe ofFIG. 3.
FIG. 15B is a perspective cross-sectional view of an alternative example embodiment of the cap ofFIG. 11 secured to the luer-restricting syringe ofFIG. 3.
FIG. 16 is a perspective cut-away view of the cap ofFIG. 11 secured to the luer-restricting syringe ofFIG. 3.
FIG. 17 is a cross-sectional view of the cap ofFIG. 11 secured to the luer-restricting syringe ofFIG. 3 as viewed along line A inFIG. 16.
FIG. 18 is a top view of an alternative example embodiment of the cap ofFIG. 12 according to another example embodiment of the present invention.
FIG. 19 is a bottom view of the cap ofFIG. 18.
FIG. 20 is a cross-sectional side view of the cap ofFIG. 18 as viewed along the major X axis.
FIG. 21 is a cross-sectional view of the cap ofFIG. 18 as viewed along the minor axis.
FIG. 22 is a side view of the cap ofFIG. 18 as viewed along the major X axis.
FIG. 23 is a perspective view of a breast-pump adaptor according to another example embodiment of the present invention, shown secured to the syringe body ofFIG. 3.
FIG. 24A is a side view of the breast-pump adaptor ofFIG. 23 as viewed along the minor Y axis.
FIG. 24B is a side view of the breast pump adaptor ofFIG. 23 as viewed along the major X axis.
FIG. 25 is a perspective cross-sectional view of the breast pump adaptor ofFIG. 23.
FIG. 26 is a perspective cross-sectional view of the breast-pump adaptor ofFIG. 23 secured to the syringe body ofFIG. 3.
FIG. 27 is a side view of a nipple adaptor according to another example embodiment of the present invention, shown secured to a commercial nipple and the syringe body ofFIG. 3.
FIG. 28 is a cross-sectional view of the nipple adaptor ofFIG. 27.
FIG. 29 is a cross-sectional view of a second alternative example embodiment nipple adaptor according to another example embodiment of the present invention shown secured to an alternative commercial nipple and the syringe body ofFIG. 3.
FIG. 30 is a cross-sectional view of a third alternative example embodiment nipple adaptor according to another example embodiment of the present invention, shown secured to an alternative commercial nipple.
FIG. 31 is a perspective view of the nipple adaptor ofFIG. 30.
FIG. 32 is a bottom view of the nipple adaptor ofFIG. 30.
DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTSThe present invention may be understood more readily by reference to the following detailed description of the invention taken in connection with the accompanying drawing figures, which form a part of this disclosure. It is to be understood that this invention is not limited to the specific devices, methods, conditions or parameters described and/or shown herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only and is not intended to be limiting of the claimed invention. Any and all patents and other publications identified in this specification are incorporated by reference as though fully set forth herein.
Also, as used in the specification including the appended claims, the singular forms “a,” “an,” and “the” include the plural, and reference to a particular numerical value includes at least that particular value, unless the context clearly dictates otherwise. Ranges may be expressed herein as from “about” or “approximately” one particular value and/or to “about” or “approximately” another particular value. When such a range is expressed, another embodiment includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another embodiment.
With reference now to the drawing figures, wherein like reference numbers represent corresponding parts throughout the several views, the drawing figures depict various embodiments of self-venting enteral syringes according to example embodiments of the present invention.FIG. 1A shows a self-ventingenteral syringe10 according to a first example embodiment of the present invention. In general, theenteral syringe10 includes anelongated syringe body20, aplunger40, and an optional cover orcap60.
Referring now toFIG. 1C, thesyringe body20 defines an internalelongate cavity22 that stretches substantially along the length of the body from anopen end26 towards a substantiallyclosed end24. In preferred example embodiments, thecavity22 substantially matches the cross-section of thesyringe body20, providing a substantially constant outer-wall thickness of the same. The substantiallyclosed end24 comprises a supply/discharge port30 and avent32, both integrally formed with thesyringe body20 and positioned generally adjacent the substantiallyclosed end24. Theclosed end24 can also include an integrally formed mountinggroove37 for coupling with the cover orcap60.
The supply/discharge port30 extends from theinternal cavity22 to the outside surface of thesyringe body20 along acircumferential wall31 and surrounds aport seal34 mounted therein. Theport seal34 can be an integral flap, and integral fluid seal or a functional seal. Similarly to the supply/discharge port30, thevent32 extends from theinternal cavity22 to the outside surface of thesyringe body20 along acircumferential wall33 and surrounds avent port seal36 positioned therein. Optionally, the supply/discharge port30 and thevent32 can be positioned in a position offset from the center of the substantially closed end of thesyringe body24. The optional offset position ofport30 and vent32 can allow a more controlled filling and uniform dispensing of fluids.
Theproximal end26 of thesyringe body20 includes anopening38 for receiving theplunger40 therein and also includes aflange23 for supporting the syringe in an upright position and assisting in use of the syringe. Optionally, theflange23 can have an asymmetric cross section, for example to prevent thesyringe10 from rolling when lying in a non-vertical position. Thesyringe body20 can have a substantially circular cross-section (as depicted inFIGS. 1-2), or can comprise an oval, elliptical, rectangular, or asymmetric cross-section as desired, and theopening38 generally has a cross-section that is sized and shaped to snugly receive an insertedcomplementary plunger40. Theplunger40 depicted in the figures comprises afirst seal41 and asecond seal43 to prevent fluid passage out of the containedvolume22, and allow the plunger to advance and retract within thesyringe body20. Optionally, the plunger can comprise one seal or may comprise two or more seals.
The cover orcap60, as shown inFIG. 1B, is removably mountable to the substantiallyclosed end24 of thesyringe body20 and comprises acircumferential wall61 extending from acircular lid panel62 having aperimeter64. A lower portion of thecircumferential wall61 comprises a partially circumferential mountingflange63 for engaging the substantiallyclosed end24 of thesyringe body20, for example the mountinggroove37 shown inFIG. 1C. An upper portion of thecircumferential wall61 comprises a pinchable orsqueezable rim68 extending above thelid panel62. Thesqueezable rim68 can pivot about theperimeter64 of thelid panel62 to disengage the lowerportion mounting flange63 from the mountinggroove37, for example to remove theclosure cap60 from the syringe. Optionally, the closure cap can be attached to the body by a hinge or keeper, or can be non-removable, for example by entirely omitting thesqueezable rim68 or by having a fully circumferential rim. Additionally, the interior portion of thelid panel62 comprises a sealingstem65 andconcentric ridges66,67, having an appearance much like a “bulls-eye” to provide a more positive seal with theport seal34. With the closure cap coupled to the substantiallyclosed end24 of thesyringe body20, thestem65 andridges66,67 formed in the underside of thelid panel62 are brought into sealing engagement with the top surface ofport seal34 and ventport seal36 to provide a more positive seal against the elements.
To ensure a proper circumferential orientation of the interior sealing elements with respect to one another, theenteral syringe10 can comprise an exposednotch28 and theclosure cap60 can comprise a recessedportion70. Thenotch28 and the recessedportion70 are engagable with each other and ensure proper orientation upon coupling theclosure cap60 to thesyringe body20. Additionally, the diameter of thecircumferential wall61 is substantially equivalent to the diameter of thesyringe body20.
In additional example embodiments,FIG. 10 shows a breast pumpattachment port assembly80 for removably coupling to the substantiallyclosed end24 of thesyringe body20. Theport assembly80 comprises acircumferential wall81 having a top portion with threading84 on the exterior surface and a bottom portion surrounding a substantially closedshelf82. The substantially closedshelf82 comprises a fill/transfer nipple86 for extending through theport seal34 and avent nipple88 for extending through thevent port seal36. The fill/transfer nipple86 (can alternatively be termed a “straw,” “port” or “spike”) comprises an elongated cylindrical tube having a hollow interior portion extending through theshelf82 to allow fluid communication with the interior of thecavity22. The vent nipple88 (can alternatively be termed a “straw,” “port” or “spike”) comprises an elongated cylindrical tube having a hollow interior portion extending along a path to the outside of thecircumferential wall81.
FIGS. 2A and 2C show an alternative embodiment of a self-ventingenteral syringe110, substantially similar to the above-describedsystem10 with differences as noted below. Thesyringe body120 defines an internalelongate cavity122 that stretches substantially along the length of the body from anopen end126 towards a substantiallyclosed end124. The substantiallyclosed end124 comprises a supply/discharge port130 integrally formed with thesyringe body120 and extending generally adjacent the substantiallyclosed end124. The supply/discharge port130 extends from theinternal cavity122 to the outside surface of thesyringe body120 along acircumferential wall131 and surrounds aport seal134. Theport seal134 is sealingly engaged within thecircumferential wall131 of theport130 with a tight friction or interference fit and can comprise a double-lumen seal190 (seeFIGS. 2E-G). The double-lumen seal190 comprises a supply/discharge lumen192 and avent lumen194. The supply/discharge lumen192 and thevent lumen194 can have substantially circular cross-sections (as depicted inFIG. 2G), or can comprise an oval, elliptical, rectangular, or non-symmetrical cross-sections as desired (as depicted inFIGS. 2E-F).
The cover orcap160, as shown inFIG. 2B, is removably mountable to the substantiallyclosed end124 of thesyringe body120 and comprises acircumferential wall161 extending from acircular lid panel162 having a perimeter164. A lower portion of thecircumferential wall161 comprises a partially circumferential mountingflange163 for engaging the substantiallyclosed end124 of thesyringe body120, for example the mountinggroove137 shown inFIG. 2C. An upper portion of thecircumferential wall161 comprises a pinchable orsqueezable rim168 extending above thelid panel162. Thesqueezable rim168 can pivot about the perimeter164 of thelid panel162 to disengage the lowerportion mounting flange163 from the mountinggroove137, for example to remove theclosure cap160 from the syringe. Optionally, the closure cap can be non-removable, for example by entirely omitting thesqueezable rim168 or by having a fully circumferential rim. Additionally, the interior portion of thelid panel162 comprisesconcentric ridges166,167, having an appearance much like a “bulls-eye” to provide a more positive seal with theport seal134. With the closure cap coupled to the substantiallyclosed end124 of thesyringe body120, theridges166,167 formed in the underside of thelid panel162 are brought into sealing engagement with the top surface ofport seal134 to provide a more positive seal against the elements.
To ensure a proper circumferential orientation of the interior sealing elements with respect to one another, theenteral syringe110 can comprise an exposednotch128 and theclosure cap160 can comprise a recessedportion170. Thenotch128 and the recessedportion170 are engagable with each other and ensure proper orientation upon coupling theclosure cap160 to thesyringe body120. Additionally, the diameter of thecircumferential wall161 is substantially equivalent to the diameter of thesyringe body120.
FIG. 2D depicts a scaled alternative embodiment of a breast pumpattachment port assembly180. Theport assembly180 has acircumferential wall181 having a top portion with threading184 on the exterior surface and a bottom portion surrounding a substantially closedshelf182 having a double-channel nipple186 (can alternatively be termed a “straw,” “port” or “spike”). The double-channel nipple186 comprises a fill/transfer channel187 and a vent channel188. The fill/transfer channel187 extends through theshelf182 to allow fluid communication with the interior of thecavity122 and is shaped to engage the supply/discharge lumen192. The vent channel188 extends along a path to the outside of thecircumferential wall181 and is shaped to engage thevent lumen194. Additionally, thecircumferential wall181 has a partially circumferential mounting flange188 for engaging the mountinggroove137 of the substantiallyclosed end124 of thesyringe body120.
In operation, thesyringe10,110 of the present invention can be used in various applications, including the enteral administration of nutrients and/or medications to a patient. External devices, such as a breast pump, can be mounted to the port assembly by the threading. When the plunger is fully engaged into the cavity, fluid from the external device can be supplied to the syringe through the fill/transfer nipple or the fill/transfer channel of the double-channel nipple. As fluid begins to fill the cavity, excess air or gas within the cavity can be removed by the vent nipple, the vent channel, or a combination of both. Additionally, a male-to-male adaptor tube can be formed. The male-to-male adaptor tube can accommodate enteral feeding by connecting the female port of the self-venting enteral syringe to a traditional female extension of an enteral feeding tube.
All of the components discussed and described herein can be formed from plastics (i.e. polypropolene), other polymers, glass, metals, metal alloys, resins, rubbers, rubber derivatives, elastomerics (i.e. santoprene), silicones or other known materials. In commercial embodiments, thesyringe body20,120 can be formed from polypropylene, polyethylene or polypropylene copolymers, the plunger is formed from the same, and the plunger seals formed fromelastomer40,140 is formed from an elastomeric. Optionally, color additivies may be added to provide protection from UV light and/or colorants may be added to thesyringe10,110 as desired and/or to identify certain properties/characteristics (i.e. administration path) or contents. In alternative embodiments, the syringe can include external markings to indicate volume capacity and remaining content levels.
An alternative embodiment enteral-only luer-restricting syringe is described inFIGS. 3-10. The luer-restricting syringe allows a single syringe body to receive, store, transport, transfer and deliver fluid within a single chamber. Alid304 is secured to an open end of acylindrical syringe body302 through a variety of methods, including friction fit, corresponding threading, tongue and groove, or adhesive. Preferably, thelid302 is integrally co-molded with thesyringe body302. Similarly to thesyringe bodies20,120 described above, thealternative syringe body302 defines an elongate interior cavity chamber for receiving and storing material, for example fluid. The syringe body305 has a generally circular circumference. A generallycontinuous groove312 is extends around the outer circumference between thelid304 and thesyringe body302. Thecontinuous groove312 can be integrally formed with thesyringe body302. Alternatively, a continuous groove can be formed around the outer surfaces of either the lid or the syringe body. As depicted, thegroove312 includes a pair ofribs306 that interrupt the continuity of the groove.Additional ribs306 can alternatively be included within thegroove312. Theribs306 act as barriers to prevent unwanted rotation of adaptors or caps with respect to thegroove312, as described further below. As depicted, thelid304 can be generally conical with apeak308 and a hollow interior. However, alternative shapes can be similarly effective.
As depicted, a female supply/discharge port assembly300, including abarrel receiver314 andchimney insert318, extends upwardly over an aperture (not shown) in thelid304. The supply/discharge port assembly300 can be secured to the lid through a variety of fixation methods, including friction fit, corresponding threading, tongue and groove, or adhesive. Preferably, thebarrel receiver314 can be integrally co-molded with thelid304. Thechimney insert318 is separably secured within thebarrel receiver314. Thechimney insert318 can be secured with respect to thebarrel receiver314 through an interference or friction fit, conjoined through adhesives, bonded through heat, radiofrequency, ultrasonic, or over-molded by molding the barrel receiver over the chimney insert. As further depicted inFIGS. 5A-5C, an integralcontinuous groove380 extends around the circumferential interior surface of thebarrel receiver314. As depicted, thebarrel receiver314 can include a pair of opposingwing recessions310 defined longitudinally-parallel along the interior surface of thebarrel receiver314 from the top edge to a defined termination position before reaching thecontinuous groove380. Alternatively, thebarrel receiver314 can include a greater or lesser number ofwing recessions310 positioned at various locations on the internal circumference. As depicted, thebarrel receiver314 has a circumferential surface with variable height at particular locations between the top and bottom openings along the circumference, thus producing a slanted bottom edge with a minimum and maximum height.
As depicted, thechimney insert318 includes anupper region354, alower region358 and aneck370. Thechimney insert318 is preferably integrally molded as a continuous unitary body and can be constructed of a rigid, durable material, for example plastic or metal. Thechimney insert318 has aninner passageway320 with a generally consistent diameter. Theupper region354 includes a top edge andtransition surface352 leading into theinner passageway320. Theupper region354 can also include a pair of opposingwing protrusions350 having a substantially similar shape and dimensions as the barrelreceiver wing recessions310. Theprotrusions350 are designed to be securely received within thewing recessions310 in thebarrel receiver314. Acontinuous ridge356 protrudes around the circumferential outer surface of thechimney insert318 and distinguishes theupper region354 from thelower region358. Thecontinuous ridge356 is designed to secure within thecontinuous groove380 in thebarrel receiver314. As depicted, theupper region354 and thelower region358 can have a generally consistent outer diameter.
Theneck370 extends from below thelower region358. Theneck370 has a smaller outer diameter than the upper354 and lower358 region outer diameters, thus producing an overhang of the lower region over the neck. Afinger protrusion333 extends onto the outer surface of theneck370. Thefinger protrusion333 has an outer-surface diameter consistent with thelower region358, thus creating a generally consistent outer surface across the lower region and the finger protrusion. Thefinger protrusion333 is designed to be received in afinger recession378 of a seal, as further described below. As depicted, theneck370 has a circumferential surface with variable height at particular locations along the circumference between the top and bottom openings, thus producing a slanted bottom edge with a minimum and maximum height.
A pair ofstops330 protrude from the interior surface of thechimney insert318. As depicted, thestops330 are positioned opposite each other along inner surface of thelower region358 of thechimney insert318. Alternatively, a single stop or multiple stops can extend from the inner surface of thechimney insert318. As depicted, thestops330 can have a tapered inwardly-facing surface that narrows in diameter toward theneck370. Alternatively, the inwardly-facing surface of thestops330 can have a consistent diameter.
Thechimney insert314 has a tapering inner diameter that is designed to receive an enteral-only syringe tip400, such as shown inFIG. 5B. A commercially-available enteral-only syringe tip400 has a tapered shape. The inner diameter of thechimney insert314 has a larger upper diameter and a smaller lower diameter in order to correspond with a commercial enteral-only tip. Upon being inserted into the top opening of thepassageway320 of thechimney insert314, the tapered enteral-only tip400 creates a friction-fit air-tight seal with the chimney at the point when the tapered enteral-only tip400 diameter matches thechimney insert314 diameter. As shown, the friction-fit air-tight seal is formed without the enteral-only tip400 contacting thestops330. This friction-fit air-tight seal allows fluids to be transferred between the enteral-only syringe400 and thesyringe body302 without acquiring outside contaminants.
As depicted inFIG. 5C, thechimney insert314 is designed to not create an air-tight seal with a commercially-available luer tip402, for example a luer-slip-tip, having dimensions defined by ISO 594/1-1986(E) and ISO 594-2:1998(E) conical fittings with a 6% Luer taper for syringes, needles and certain other medical equipment, hereby incorporated by reference for all purposes. A commercially-available luer tip402, or luer-slip-tip has a smaller minimum diameter and smaller maximum diameter than the enteral-only tip400. As depicted, thestops330 prevent theluer tip402 from extending within thechimney insert314 to a distance that would be required for theluer tip402 to form an air-tight friction-fit with the chimney insert. Specifically the distance between thestops330, specifically the inwardly-facing surface has a maximum of, or is preferably less than, 3.925 mm, which is the minimum diameter for a 6% Luer tip end of the male conical fitting as defined by ISO standards. Additionally, the diameter of the top opening of thechimney insert318 has a minimum of, or is preferably greater than, 4.315 mm, which is the maximum diameter at the opening of a female conical fitting to receive a 6% luer conical fitting. This inability to form a friction-fit air-tight seal prevents thechimney insert314 from being effectively used with aluer tip402 because contaminants cannot be excluded from any liquid being transferred between the luer tip and thesyringe body302. This meets the provisions of such standards as ISO 80369 by restricting engagement of luer connectors and enteral connectors to prevent intermingling of the fluid paths.
Aseal attachment362 is depicted to attach with respect to theneck370 of thechimney insert318. Theseal attachment372 has a continuouscircumferential collar372 that fits around theneck370 and has an outer diameter that is generally consistent with the outer diameter of thelower region358 of thechimney insert318. The continuouscircumferential collar372 also has afinger cutout378 to receive thefinger protrusion333 on thechimney insert318.
The continuouscircumferential collar372 is secured around theneck370 through a friction-fit and/or an adhesive. Theseal attachment372 includes a pair offlaps374. As depicted, theflaps374 have a generally semi-circular shape with a smaller diameter than the interior diameter of the continuouscircumferential collar372, thus providing a generally-continuous gap364 between the flaps and the continuous circumferential collar. Theflexible flaps374 are secured to the continuouscircumferential collar372 through a pair of bridge mounts376. As depicted, theflaps374 are separated by anelongated channel377. Theseal362 is preferably constructed as a single unitary body including the continuouscircumferential collar372, the bridge mounts376 and theflaps374. Theseal attachment362 is preferably constructed of a flexible material, for example plastic, rubber or silicone.
In use, theseal attachment372 is secured with respect to thechimney insert neck372 and theflaps374 prevent or restrict solid particles from entering or exiting thesyringe body302 and to augment the flow of fluid into and out of the syringe body. Alternatively, theflaps374 can be secured directly to thecircumferential collar372 without thegap364. Alternatively still, theflaps374 can resiliently rest together forming an air-tight seal that is only broken with a protruding body, for example a tube or straw, that is forced between the flaps.
As depicted inFIGS. 11-22, thesyringe body302 can be stored or transported standing vertically upright on aplatform406. In storage or transport, the contents held within the internal chamber ofsyringe body302 can be protected with aremovable cap500.
Thecap500 has a topplanar surface502 and a generallycontinuous collar504 extending downwardly from the edge of the top planar surface. Thecollar504 can have a consistent height from the topplanar surface502 to a distal edge. The generallycontinuous collar504 is preferably constructed of resiliently-flexible material, for example plastic. As depicted, the topplanar surface502 can have an elliptical shape with a major (X) axis and a minor (Y) axis. Afirst pinch recession508 can be formed at one end of the major (X) axis. Asecond pinch recession510 can be formed at an opposite end of the major (X) axis. The first508 andsecond pinch recessions510 can extend partially along the topplanar surface502 and generally across the height of thecollar504. In use, inwardly-directed pinching pressure applied simultaneously to the first508 and second510 pinch recessions, along the major (X) axis, causes the resiliently-flexible collar504 to change its shape to shorten the major (X) axis and lengthen the minor (Y) axis. When this simultaneous pressure is released, the resiliently-flexible collar504 returns to the pre-pressure relaxed state.
A pair ofteeth grips514 extend inwardly from the interior surface of thecollar504. As depicted, the teeth grips514 can be positioned diametrically opposite each other, and separated by and along the minor (Y) axis. Alternatively, additional pairs of teeth grips at alternative locations can be similarly effective. The teeth grips514 are preferably integrally co-molded with thecap500. The teeth grips514 have a shape that is designed to removably insert into thecontinuous groove312 between thelid304 and thesyringe body302 described above. In a relaxed state without application of a pinching pressure described above, the minor (Y) axis length is shorter than the diameter of thesyringe body302. In a similarly relaxed state, the minor (Y) axis length is generally equivalent to the distance between opposing points along the inner-most surface of thecontinuous groove312. In the relaxed state, the resilient force of thecap500 presses the teeth grips514 into thecontinuous groove312, thus preventing the cap from involuntary removal during transport or storage. Correspondingly to that described above, applying a simultaneous major (X) axis pinching pressure to eachpinch recession508,510 elongates the minor (Y) axis and removes the teeth grips514 out of thecontinuous groove312 so that thecap500 can be removed. In use a depicted inFIG. 17, the teeth grips514 preferably insert into thecontinuous groove312 between the pair ofribs306 to prevent thecap500 from rotating with respect to the groove.
As depicted, a plug is secured through an aperture (not shown) in the top surface region of thesecond pinch recession510. The plug includes a base that secures above thetop surface502 and a rigid probe that extends through the aperture (not shown) and below the top surface. The plug is preferably integrally constructed of a unitary single-body construction. The probe preferably is tapered and has dimensions that are generally consistent with an enteral-only tip, similar to thetip400 described above. Afirst example plug506 can have an opening in thedistal end519 of theprobe518 with a hollow bore extending to aclosed base516. Alternatively as shown inFIG. 15B, a second example plug can have a base516B with anopening517 and a bore that extends into aprobe518B that has a closeddistal end519B. Alternatively still, a third example plug can have a solid base and solid probe without any openings or internal bores.
The plug can be separately constructed and then fixed through thecap500 through a variety of fixation methods, including friction fit, threading, and adhesive. Preferably, the plug can be integrally co-molded with thecap500 to form a unitary body.
In use, theprobe518,518B inserts into thepassageway320 in the above-describedchimney insert318 until it forms an air-tight friction-fit seal similar to that described with the enteral-only tip400. This seal is air-tight and prevents unwanted material from entering or exiting thesyringe body302 during storage or transport.
Arigid support512 extends downwardly from the topplanar surface502 within thecap500. As depicted, thesupport512 can have a semi-circular wall shape with a disconnect. As further depicted, thesupport512 can be positioned with respect to thecap500 such that theplug506 is positioned within the disconnect of the semi-circular wall shape. As depicted, theplug506 andsupport512 can be aligned offset from center along the major (X) axis. In use, when theprobe518,518B is inserted into thechimney insert318, a distal edge of thesupport512 contacts thelid304. This contact between thesupport512 and thelid304 assists to prevent theprobe518,518B from inserting an unwanted distance into thechimney314, as shown inFIGS. 15A-16. The semi-circular shape of thesupport512 corresponds with the cone shape of thelid304 to maintain an even distribution of support. The proximal end of thesupport512 can be fixed to thecap500 through a variety of fixation methods, including friction-fit and adhesive. Preferably, thesupport512 is integrally co-molded with thecap500 to form a unitary structure.
As depicted inFIGS. 18-22, an alternative cap500A can align aplug414 andsupport422, of similar design and structure to plug506 andsupport512 described above, along the center of the minor (Y) axis, thus turned ninety degrees and shifted toward center from thecap500 described above. Similarly to thecap500 described above, a pair ofteeth grips416 are depicted to align along and be separated by, the minor (Y) axis.
Anelongated marker412 can integrally protrude from the outer surface of the cap500A and extends from the plug downwardly along the outside of thecollar418. Thismarker412 assists a user to align the cap500A with amarker702 on thesyringe body302 described below inFIG. 23. Themarker412 can alternatively be a recessed groove or surface indicator. A similar marker can be integrated withcap500.
As depicted, thecollar418 can have a variable height from the top planar surface to the distal edge. As viewed along the major (X) axis inFIG. 22, the distal edge can have a pair of opposing convex outward arcs430. As viewed along the minor (Y) axis inFIG. 21, the distal edge can have a pair of concaveinward arcs432. There can be a smooth transition between the convex430 and concave432 arcs. Apinch grip434 having a textured criss-crossed or embossed pattern, or similar surface, is depicted to be present on a side of the cap so as to improve usability. As depicted, thepinch grip434 can be located on the outer surface along the major (X) axis of the cap. Alternatively, thecollar418 can have a pair of opposing pinch grips on either end of the major (X) axis.
FIGS. 23-28 shows anadaptor704 that can attach to the enteral-only syringe described above. As depicted, theadaptor704 has abase region710, amouth region714 and atransition waist712 between the base and the mouth. There is anopening720 through themouth714 and anopening730 through thebase710. As depicted, themouth region714 andwaist region712 have a generally circular circumference. Thewaist712 is depicted to have a smaller diameter than themouth714. Themouth714 can include anattachment mechanism708, for example a threaded outer surface, to attach a standard commercially-available breast pump.
As depicted inFIGS. 24A and 24B, thebase region710 can have an elliptical shape similar to thecap collars504,418 described above.FIG. 24A shows thebase region710, as viewed along the minor (Y) axis andFIG. 24B shows the base region as viewed along the major (X) axis. Similarly to thecap collars504,418 described above, thebase region710 is preferably constructed of resiliently-flexible material, for example plastic. In use, pinching pressure applied simultaneously to the opposing ends of thebase region710, along the major (X) axis, causes the resiliently-flexible base710 region to change its shape to shorten the major (X) axis and lengthen the minor (Y) axis. When this simultaneous pressure is released, the resiliently-flexible base region710 returns to the pre-pressure relaxed state and dimensions.
As depicted, thebase region710 can include apinch grip711 on one of the opposing ends of the major (X) axis to improve usability when applying pinch pressure. Alternatively, thebase region710 can have a pair of opposing pinch grips on either end of the major (X) axis. Thepinch grip711 can have a criss-crossed, embossed or similar textured appearance.
Afunnel723 separates, and enables fluid passage between, the interior of themouth region714 from the interior of thebase region710. Thefunnel723 includes a generally-circumferential slide738 that directs any liquid or material downward towards aport732. Theport732 is depicted to be hollow and elongated and has a distal end that extends within thebase region710 of theadaptor704. Theslide738 extends from the inner wall of theadaptor704 and includes a downwardly-sloped surface. The downwardly-sloped surface extends towards theport732. Theport732 is preferably positioned off-center and toward an end of the major (X) axis, preferably near thewaist712.
Asupport734 extends downwardly away from theslide738. Thesupport734 can have a semi-circular wall shape with disconnect similar to thesupports512,422 in thecaps500,410 described above. Thesupport734 can also be positioned such that theport732 is situated within the disconnect of the semi-circular wall shape. In use, theport732 is inserted into the passageway329 of thechimney318 in thelid304. Theport732 has a narrow diameter preventing the port from creating a, air-tight seal with thechimney insert318. Theport732 has a length that allows it to extend through thechannel377 between theflaps374 in the seal without forming an air-tight seal. This allows easy introduction of liquid into thesyringe body302 with simultaneous venting of any trapped air within the syringe body chamber. A distal end of thesupport734 contacts thelid304 without applying any pressure to the lid. This alignment of thesupport734 and thelid304 assists to prevent theport732 from inserting an unwanted distance into thechimney314, as shown inFIG. 26. The semi-circular shape of thesupport732 corresponds with the cone shape of thelid304 to maintain an even distribution of support.
Similarly to the alternative cap500A described above, the position of the port, funnel and support in theadaptor704 can be turned ninety degrees and centered to aligned along the minor (Y) axis.
Similarly to thecaps500,410 described above, the adaptor700 can include a pair of similarly-designed teeth grips736 that extend inwardly from the interior surface of thebase region710. The teeth grips736 can extend from diametrically opposed locations along the major (X) axis of thebase region710. Alternatively,additional teeth grips736 at alternative locations can be effective. The teeth grips736 are preferably co-molded with theadaptor704. The shape of the teeth grips736 is designed to removably insert into thecircumferential groove312 between thelid304 and thesyringe body302. The resilient force of thebase region710 presses the teeth grips736 into thecircumferential groove312 when the base region is in a relaxed state, thus preventing theadaptor704 from involuntary removal during use. Applying simultaneous inward pinching pressure to opposing ends of the base710 major (X) axis elongates the minor (Y) axis and removes the teeth grips736 out of thecircumferential groove312 so that theadaptor704 can be removed. Similarly to thecaps500,410 described above, the teeth grips736 preferably insert between the pair ofribs306 in thegroove312 to prevent theadaptor704 from rotating within the groove.
Thesyringe body302 can alternatively have amarker706 that aligns with acorresponding marker706 on theadaptor704 when the adaptor is secured to the syringe body. As depicted inFIG. 26, themarkers702,706 can be elongated etchings on the exterior surface of thesyringe body302 andadaptor704, however, alternative shapes are considered effective. Themarkers702,706 can alternatively be bodies protruding from the outer surface or surface indicators.
A commercially-available nipple attachment is shown inFIGS. 27-29 to secure to thesyringe body302 through anadaptor810 described above. Thenipple attachment800 includes aflexible nipple802, for example an Abbot®, or Evenflo® brand nipple. Thenipple802 has acircumferential lip804 that is secured between a threaded collar/ring806 and anadaptor810. When thenipple802, threaded collar/ring806 andadaptor810 are secured to thesyringe body302, liquid contained within the syringe body can be forced outward through the nipple.
The threaded collar/ring806 has a circumferentialtop surface822 with a central aperture through which thenipple802 extends upwardly. Thehandle806 also has acircumferential underhang824 positioned in a parallel plane beneath thetop surface822. Agrip surface820 extends circumferentially perpendicular between thetop surface822 and theunderhang824. Afastening mechanism826, for example a snap-on feature, extends along the inner facing surface of thevertical grip surface820. The snap-onfeature826 can secure to a corresponding snap-on on theadaptor810, as described below. Preferably, the threaded collar/ring806 is integrally molded as a unitary structure.
The depictedadaptor810 includes anouter collar830 positioned perpendicularly to ashelf836. Thecollar830 preferably has an elliptical circumference similar to thecaps500,410 described above. Theshelf836 can have a generally circular circumference. As depicted, theshelf836 can have a circumferential wall extending perpendicularly away from the edge of the circular shelf and afastening mechanism833, for example a snap-on feature, to cooperate with thefastening mechanism826. Thelip804 of thenipple802 is secured between thelid822 and theshelf836.Several ribs838 extend perpendicularly upward from theshelf836 and align with the interior surface of thenipple802 to prevent thenipple802 from collapsing during use. Alternatively, theribs838 can be a single circumferential structure that lines the entirety of the internal surface of thenipple802.
FIG. 29 presents analternative nipple attachment900 to that shown inFIG. 28. Theattachment embodiment900 has a generally-consistent construction, design and function as theattachment810, but includes an extendedanti-collapse seal908 instead of theanti-collapse ribs838. Theanti-collapse seal908 includes asupport section904 that conforms to the shape of thenipple802 and abarrier section906 that extends from the ends of the support section. Theanti-collapse seal908 includes a resiliently-sealable aperture912 near the center of the barrier. Theanti-collapse seal908 ensures an air-tight seal that allows for use without amovable plunger808.
Similarly to thecaps500,410 described above, theadaptor collar830 is preferably constructed of resiliently-flexible material, for example plastic and has an elliptical shape with a major (X) axis and a minor (Y) axis. In use, pinching pressure applied simultaneously to the opposing ends of the major (X) axis of theadaptor collar830 causes the resiliently-flexible collar to change its shape to shorten the major (X) axis and lengthen the minor (Y) axis. When this simultaneous pressure is released, the resiliently-flexible collar830 returns to the pre-pressure relaxed state and dimensions.
Asupport842, similar to thecap500 described above, extends downardly from theshelf836. Thesupport842 can have a semi-circular wall shape with a disconnect and thesupport842 can be positioned with respect to theshelf836 such that an enteral-only tip840 is positioned within the disconnect of the semi-circular wall shape. The enteral-only tip840 extends from the underside of theshelf836, as depicted. The enteral-only tip840 forms an air-tight interference or friction-fit seal with thechimney insert318, similarly to theplug516 described above. Acover seal839 can extend across the opening of the enteral-only tip840 to prevent entry and exit of ambient air with respect to thesyringe body302. Thecover seal839 ensures an air-tight seal that allows for use without amovable plunger808. In use, when the enteral-only tip840 is inserted into thechimney insert318, a distal edge of thesupport842 contacts thelid304. This alignment of thesupport842 and thelid304 assists to prevent the enteral-only tip840 from inserting an unwanted distance into thechimney314. The semi-circular shape of thesupport842 corresponds with the cone shape of thelid304 to maintain an even distribution of support. Theport840 andsupport842 can be aligned off-center along the major (X) axis within theadaptor collar830.
A pair of teeth grips832, similar in design, construction and function to theteeth416,514 described above, extend inwardly from the interior surface of thecollar830. As depicted, pair ofteeth grips832 can extend from diametrically opposed locations separated along the minor (Y) axis of thecollar830. Alternatively, additional pairs of teeth grips at alternative locations can be effective. The teeth grips832 are preferably co-molded with theadaptor810. The shape of the teeth grips832 is designed to removably insert into thecontinuous groove312 between thelid304 and thesyringe body302. The resilient force of thecollar830 presses the teeth grips832 into thecontinuous groove312 when the collar is in a relaxed state, thus preventing theadaptor810 from involuntary removal during use. Applying simultaneous inward pinching pressure opposing ends of the major (X) axis of thecollar830 elongates the minor (Y) axis and removes the teeth grips832 out of thecontinuous groove312 so that theadaptor810 can be removed. The teeth grips832 preferably inserted between the pair ofribs306 in thecontinuous groove312 to prevent thecollar830 from rotating within the groove.
Alternatively, as shown inFIGS. 30-32, anipple attachment962 with a commercially-available nipple964 secured to a handle can be secured to analternative adaptor960. Thenipple964 is secured beneath acircumferential lid966 with acircumferential handle968 having an internal threadedsurface970. Theadaptor960 has an outer wall with a corresponding circumferential threadedsurface976 that can secure to the handle threadedsurface970. Theadaptor960 includes acollar972 that is positioned within the circumference of the outer wall circumferential threadedsurface976. Thecollar972 has a greater height than the outer wall circumferential threadedsurface970. Thecollar972 can have an elliptical circumference with a major (X) axis and a minor (Y) axis. Similarly to the breast-pump adaptor704 described above, thenipple adaptor960 has an elongatedport980 with aproximal opening989 and adistal opening991 extending from ashelf975. Thenipple adaptor960 also has asupport978 that is depicted to have a semi-circular wall shape with a disconnect. As depicted, theport980 is positioned within the disconnect of thesupport978. Similarly to the alternative cap500A, theport980 and thesupport978 can be centrally-aligned along the minor (Y) axis within thecollar972. Theadaptor960 can also include a raised platform or seal957 secured with respect to the top surface and interfacing with thenipple964. This raised platform or seal957 can be a ring-shape constructed of flexible material, for example rubber or silicone. Theseal957 can have an adjustable dimension, for example diameter, and is preferably ribbed, to allow for venting of trapped air. Thenipple964 rests with respect to the raised platform or seal957 so as to allow the venting of air as liquid passes through towards and outward from the nipple.
In use, thedistal opening991 of theport980 inserts into thepassageway320 in the above-describedchimney insert318 until it forms a friction-fit similar to that with the enteral-only tip400. The friction fit is air-tight and prevents unwanted material from entering or exiting thesyringe body302 during use.
Theadaptor collar972 is preferably constructed of resiliently-flexible material, for example plastic and has an elliptical shape with a major (X) axis and a minor (Y) axis. In use, pressure applied simultaneously to the opposing ends of the major (X) axis of theadaptor collar972 causes the resiliently-flexible collar to change its shape to shorten the major (X) axis and lengthen the minor (Y) axis. When this simultaneous pressure is released, the resiliently-flexible collar972 returns to the pre-pressure relaxed state and dimensions.
A pair ofteeth grips974 similar in design, construction and function to theteeth416,514 described above extend inwardly from the interior surface of thecollar972. As depicted, the pair ofteeth grips974 can extend from diametrically opposed locations separated along the minor (Y) axis of thecollar972. Alternatively, additional pairs of teeth grips at alternative locations can be effective. The teeth grips974 are preferably co-molded with theadaptor960. The shape of the teeth grips974 is designed to removably insert into thecontinuous groove312 between thelid304 and thesyringe body302. The resilient force of thecollar830 presses the teeth grips832 into thecontinuous groove312 when the collar is in a relaxed state, thus preventing theadaptor810 from involuntary removal during use. Applying simultaneous inward pinching pressure opposing ends of the major (X) axis of thecollar830 elongates the minor (Y) axis and removes the teeth grips832 out of thecontinuous groove312 so that theadaptor810 can be removed. The teeth grips832 preferably inserted between the pair ofribs306 in thecontinuous groove312 to prevent thecollar830 from rotating within the groove.
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.