Feeding nipple with reinforcement

188328/4 27.6.06 27.6.06 27.6.06 27.6.06

FEEDING NIPPLE WITH REINFORCEMENT

FIELD OF THE PRESENT INVENTION

The present invention generally relates to an artificial nipple for use with a bottle for the purpose of feeding, such as an infant.

BACKGROUND OF THE INVENTION

The merits of breast-feeding are well documented in the scientific literature. A number of advantages have been noted which include nutritional, immunological,psychological and other general health advantages. A list of the merits of human breast milk as compared to artificial feed or formula would include ideal nutritionalcontent, better absorption, fewer food related allergies, more favorablepsychological development, better immunological defenses, and a substantialeconomic advantage. Another benefit to exclusive breast-feeding includes positive effects on development of an infant's oral cavity resulting in proper alignment ofteeth and other related benefits.

For various reasons, however, exclusive breast-feeding is not alwayspossible. An example of this would be where a nursing mother cannot produceenough breast milk to feed her infant. In such cases, an artificial feed may be usedto supplement breast-feeding. A nursing mother returning to work may employ abreast pump to express milk to be given to her infant at a later time. In the eventthat an infant is fed with an artificial formula or previously expressed breast milk, it is conventional that a bottle provided with an artificial nipple is used to feed the infant.

The mechanical aspects of breast-feeding are significantly differentcompared to that of bottle-feeding. In breast-fed babies, the tongue action appearsto be of rolling or peristaltic motion. However, the tongue action for bottle-fedbabies is often considered to be more piston-like or a squeezing motion. In order to stop the abundant flow of milk from a bottle with an artificial nipple having a largehole in the end, infants might be forced to hold the tongue up against the hole of thenipple to prevent the formula from gushing forth. This abnormal activity of thetongue is referred to as tongue thrust or deviate swallow. When breast-fed babiesare not sucking or swallowing, they may rest with the nipple moderately indented bythe tongue, while bottle-fed babies rest with the teat expanded, i.e., indenting thetongue. The differences between the tongue movements and rest position of thetongue and breast-fed and bottle-fed babies are probably due to the properties ofthe artificial nipple. 01804012\105-01 1 188328/4 27.6.06 27.6.06 27.6.06

The undesirable effects of existing artificial nipples are often permanent andcorrection later in life is difficult due at least in part to effected muscle development.The shape of a breast nipple is dictated by the internal geometry of the infant's mouth during breast-feeding. However, an artificial teat is already formed with a specific shape and is made from a material stiffer than breast tissue.

Recent research suggests that in the early stages of oral cavity development,the palette is almost as malleable as softened wax. As a result, children who arebottle-fed are nearly twice as likely to have malocclusions as children who are breast-fed. In the same way that finger sucking and use of a pacifier-like object hasbeen found to increase the prevalence of malocclusions it is now believed that useof a conventional artificial nipple also impacts negatively upon formation of the oralcavity. A demand therefore exists for an artificial nipple that more closely mimicsthat of a natural breast and reduces or eliminates the impact of bottle-feeding withrespect to oral development. The present invention is believed to satisfy this demand.

The following are examples of prior art references related to the presentlydisclosed subject matter: WO 2004/043325 teaches an artificial baby-feeding nipple (310) including asubstantially solid nipple portion (312) with one or more ducts (316) formedtherethrough for conveying fluids through the nipple. The nipple is radially compressible so as to prevent passage of fluids through the one or more ducts (316) when so compressed through use of a material having a low durometer material. WO 2004/010921 teaches a hollow nipple that is constructed to reducetearing of the nipple's indented neck portion 3 due to contact with the infant's teeth.In one embodiment, the wall of the nipple includes a fiber net 20 taking the form ofstripes within the thickness t of the nipple body 1 and extending in a lengthwise direction L of the nipple body 10. The fiber net 20 provides reinforcement of the nipple body 10 itself by delaying or preventing complete breakage of the neck portion 14. US 2004/0182813 teaches a reinforcing tube 28 that extends through apassageway 22 communicating the fluid openings 24 with the interior of a bodyportion and preventing a nipple 14 from collapsing upon being sucked on by anewborn. 01804012\105-01 2 188328/4 27.6.06 US 6,588,613 discloses a nipple 38 that comprises a separately fabricated capillary bundle core 40. The body of core 40 is solid and has at least one fluid delivery passage 42. This nipple core material may be more firm or rigid than the nipple body material in order to better keep the fluid-delivery capillaries open when the baby bites on the nipple.

SUMMARY OF THE INVENTION

An object of the invention is to provide an artificial nipple that is made of amaterial that minimally impacts infant oral development. Another object of the invention is to provide an artificial nipple that permits milk to flow therefrom at typicalbreast-feeding suction levels. Yet another object of the invention is to provide an artificial nipple that does not permit milk to flow through or substantially stops thatflow when compressed, or constricted radially through elongation. Still yet anotherobject of the invention is to provide an artificial nipple that is positioned in the oralcavity in a similar fashion as that of a mother's nipple. Another object of theinvention is to provide an artificial nipple that permits milk or other fluids to flow therefrom in a manner and rate similar to that of a mother's nipple.

Overall, the nipple of the present invention is designed in one broad sense to encourage a suck/swallow/breathe pattern similar to that of natural breastfeeding.This reduces or eliminates the undesired forcing of breast milk to a feeding infant.

In one aspect of the present invention, a baby feeding apparatus includes a substantially solid nipple with one or more ducts formed therethrough for conveyingfluids through the nipple. The nipple is radially compressible so as to preventpassage of fluids through the one or more ducts when so compressed. Similarly,the nipple constricts radially so as to prevent passage of fluids when elongated(stretched).

In a particular aspect of the foregoing invention, the nipple may be a Shore Ahardness of less than about 10, and even below 1. More particularly, on the Shore 00 scale, a range of about 20 to about 45 is presently considered most desirable.The nipple may include three or more elongated ducts. The fluid ducts may further be offset radially with respect to a central axis of the nipple in another variation.Further still, the end openings of the ducts can be radially offset relative to the central axis of the ducts themselves.

In one embodiment, the nipple may include a unitary nipple portion andmounting portion. The mounting portion may be formed of a material having the01804012\105-01 3 188328/4 27.6.06 same Shore A hardness as that of the nipple portion, but in this embodiment, the

mounting portion may be formed of a material having a relatively higher Shore A hardness to that of the nipple portion. This provides a more rigid structure for attachment to a container, for instance.

In another form, the nipple may include a nipple end and a body portion. Thebody portion may include a vent formed therethrough, or multiple vents. The ventmay include a horizontal passageway in communication with atmosphere, and a vertical passageway in communication at a first end to the horizontal passageway and at a second end to an inner chamber of the nipple.

Another aspect of the invention provides a baby feeding apparatus includinga substantially solid nipple being formed of a material having a Shore A hardness ofless than about 10, and one or more ducts at or near the nipple tip for conveying fluids through the nipple, and most preferably extending through the generally solidnipple portion.

Yet another aspect of the invention provides a baby feeding apparatusincluding a substantially solid nipple having one or more ducts formed therethroughfor conveying fluids through the nipple, and a flow restrictive feature. One flow restrictive feature prevents passage of fluids through the one or more ducts when the nipple is one or both of radially compressed and axially extended. Another is just the small size of the terminal hole at the end of a duct as disclosed herein, which is sufficient alone to restrict fluid flow, as well as the use of a valve or valve- like end feature. It has been observed that these flow restrictive features reduce theamount of air that could otherwise return to the fluid container. With the ventedstructure disclosed herein, this serves to prevent the infant (user) from taking inunwanted air with feeding. The ducts may be round in cross-section. In anotherembodiment, the ducts may terminate in longitudinal slits. In yet another embodiment, the ducts may terminate in “S”-shaped slits or “Y”-shaped slits.

Yet another aspect of the invention provides an integral (one-piece) nursingnipple including a substantially solid nipple formed of a material having a Shore Ahardness of less than about 10, and a container attachment portion formed to beunitary with the nipple portion.

Yet another aspect of the invention provides an integral nursing nippleincluding a substantially solid nipple portion formed of a material having a Shore Ahardness of less than about 10, and an extending elongated portion sized and shaped to be insertable into the mouth of a nursing infant. The extending portion 01804012\105-01 4 188328/4 27.6.06 includes a proximal portion and a base portion and one or more ducts through the solid nipple portion from the proximal portion to the base portion. The base portion has a radial flange extending outwardly therefrom, and a container attachment portion formed to be unitary with the nipple portion. The container attachment portion is generally cylindrical, and has a first end connected to the radial flange anda second end. The second end includes an internal groove formed about aninternal periphery thereof. The internal groove is sized and shaped so as to beremovably attachable to a container having a matching thread (although this matingthread and groove arrangement could be reversed).

Yet another aspect of the present invention provides an integral nursingnipple including a substantially solid nipple formed of a material having a Shore Ahardness of less than about 10, and an extending portion sized and shaped to beinsertable into the mouth of a nursing infant. The extending portion includes one ormore ducts extending therethrough for conveying fluids, and a base portion. A container attachment portion is attached to the base portion. The container attachment portion is generally cylindrical and has a first end with a flange. The flange extends inwardly from the first end and includes a plurality of openings formed therethrough. In manufacture the soft base portion enmeshes with the flange through the openings. The container attachment portion includes means for attachment to a container, such as screw threads, a snap-fit, etc.

Another aspect of one embodiment of the invention is to provide as low aDurometer material for the nipple portion of the artificial nipple as possible.Preferably, a relatively higher durometer material is provided for the collar portion.The nipple portion may be molded or connected directly to the collar or mountingportion or may be a more conventional nipple/collar configuration.

Still another aspect of an embodiment of the invention is the positioning of avalve at the distal end of each duct to regulate the flow of fluids through each duct.The valve is designed to open and close depending on the suckling action.

One of the most significant attributes of the present invention is nonethelessconsidered to be the very low Durometer material of the nipple extending portion,and how that material behaves under manipulation by the infant in suckling, both inextension and also in compression. The elongated duct(s) in the preferred substantially solid embodiment appear to react much more like a mother's nipple than any prior art artificial nipple with this very low Durometer material. The infant also is believed to engage the soft area surrounding and extending outwardly from 01804012\105-01 5 188328/4 27.6.06 27.6.06 27.6.06 the distal end of the extending portion in a manner much more reminiscent offeeding at the breast. Furthermore, and unlike many prior art artificial nipples, thepresent invention permits the fluid flow characteristics of the nipple to respond tochanges in vacuum. It is believed that the low Durometer material of the nipple,possibly in combination with other features of the present invention, can be tailoredto allow a higher fluid flow rate at a relatively increased vacuum (by the infant).

As will be evident herein, the most preferred durometers are considered tobe in the range at or below about Shore A 5, which would be most preferablyaround Shore 00 20 to 45. Even below the latter range may be useful.

Another way to look at the desired result in this nipple insofar as extensionand compression under suckling, is through the elongation of the nipple material.Materials that have appeared very useful for the elongated portion of the nipplehave shown a stress of approximately 40 psi or less at 300% elongation in a mostpreferred embodiment.

The present invention represents an improvement in the artificial nipplepreviously disclosed in the foregoing application, through the use of various meansto reinforce the elongated part of the nipple that extends into the user's mouth.

These, together with other objects and advantages will be further understoodin the details of the construction and operation of the invention as more fullyhereinafter described, reference being had to the accompanying drawings, forminga part hereof, wherein like numerals refer to like part throughout.

BRIEF DESCRIPTION OF DRAWINGS FIG. 1 is a sectional view of one embodiment of a nipple according to thepresent invention; FIG. 1A is an enlarged view of ducts with valves in a variation of the nipple of FIG. 1; FIG. 2 is a reduced-size bottom view of the nipple of FIG. 1; FIG. 3 is a perspective view of a second embodiment of an integral nippleaccording to the present invention; FIG. 4 is a top perspective view of the collar portion of the nipple of FIG. 3; FIG. 5 is a bottom perspective view of the collar portion of FIG. 4; FIG. 6 is an enlarged and partially sectional illustration of a portion of thenipple of FIG. 3; 01804012\105-01 6 188328/4 27.6.06 FIG. 7 is an enlarged and partially sectional illustration of another portion ofthe nipple of FIG. 3; FIG. 8 is an enlarged bottom perspective view of the nipple of FIG. 3; FIG. 9 is a perspective view of a third embodiment of an integral nippleaccording to the present invention; FIG. 10 is a sectional view of a fourth embodiment of a nipple according tothe present invention; FIG. 11 is an enlarged partial sectional view of a mounting portion of thenipple of FIG. 10; FIG. 11A is a partial cut-away perspective view showing the vent of FIG. 11; FIG. 12 is a bottom view of one embodiment of an arrangement of fluid ductsaccording to the present invention; FIG. 13 is a sectional view of an embodiment of a nipple similar to thatshown in FIG. 10, illustrating some of the nipple dimensions; FIG. 14 is an enlarged partial sectional view of the nipple of FIG. 10; FIG. 15 is an enlarged partial sectional view of another embodiment of thenipple of FIG. 10; FIGS. 16A-16C are sectional views of various types of termini for ducts; and FIGS. 17A-17B are end views of nipples formed with the foregoing termini. FIG. 18 is a sectional view of one embodiment having a tubular meshreinforcement embedded in the nipple; FIG. 19A is a cross-sectional view looking along the long axis of a helical-type extrusion for use as a reinforcement element in a nipple; FIG. 19B is a perspective view of the embodiment of FIG. 19A; FIG. 20 is a cross-sectional view looking along the long axis of anotherembodiment of a reinforcing element to be embedded in the nipple; FIG. 21 is a cross-sectional view looking along the long axis of anotherembodiment of a reinforcing element to be embedded in the nipple; FIG. 22 is a cross-sectional view looking along the long axis of anotherembodiment of a reinforcing element to be embedded in the nipple, where both theinterior and exterior of the element have been modified from a smooth circle; and FIG. 23 is a view looking from the bottom up toward the top (proximal end) ofanother embodiment of a nipple having an internal web-type reinforcement membersimilar to that of FIG. 20. 01804012\105-01 7 188328/4 27.6.06 27.6.06

DESCRIPTION OF PREFERRED EMBODIMENTS FIG. 1 shows an embodiment of a nipple, illustrated generally at 10, for usewith a container, such as a bottle or bag. The nipple 10 may be made of any suitable material, but in a preferred form is made of a silicone material, such assilicone rubber. Preferably, the nipple material may be silicone, but couldalternatively be other materials, such as thermoplastic elastomers (TPE's), such as polyisoprene, and others compatible for nursing.

It will be noted that, while described in the environment of human infant feed,the invention has broader application to animal feeding, providing fluids to non-infants, and so on.

The nipple 10 here is formed of two subparts including a substantially solid nipple portion 12 at a proximal end thereof for insertion into an infant's mouth andfor conveying fluids therethrough from an attached bottle (not shown). Proximal and distal, being indicative terms, are chosen here with respect to the user (e.g., theinfant). The nipple portion is a generally cylindrical substantially solid body.However, it is understood that the nipple can be in other shapes such as“orthodontic” designs. The term “substantially solid”, for purposes of the presentapplication, is broadly defined as a range from completely solid (i.e., including novoids or hollows except for the existence of one or more generally narrow ducts 20for conveying fluid), to having a hollow interior defined by sidewalls that include oneor more ducts formed therethrough where the ducts have a significantly greaterlongitudinal length than radial width. As will be appreciated, there are certainfunctional attributes for the “solid” nipple portion 12 of this aspect of the invention that do not require a completely solid construct.

Preferably, the material of which the nipple portion 12 is fabricated has aDurometer A (or Shore A) hardness that is substantially within the range of about 1to about 20. More preferably, the first material has a Durometer A hardness that iswithin the range of 1 to about 3, or switching to the Shore 00 scale, most preferablyin the range of about 20 to about 45. Below the latter range is nonetheless alsoconsidered efficacious. It will be understood that the use of the phraseology “lessthan x” or “less than about x” includes x.

The nipple 10 includes a second subpart or mounting portion 14 formed at adistal end thereof, which is designed to be attachable to a container in a fluid-tightmanner. Alternatively, a secondary collar or like attachment piece could be used to 01804012\105-01 8 188328/4 27.6.06 27.6.06 attach the nipple 10 to the container. The material of which mounting portion 14 is fabricated preferably has a Durometer A hardness that may be formed of the sameor a greater Durometer hardness than nipple portion 12. In one embodiment, themounting portion 14 has a Durometer A hardness that is within the range of about 1to about 100. More preferably, the material of the mounting portion 14 has a

Durometer A hardness that is substantially within the range of about 20 to about 90,or even more preferably in the range of about 70 to about 90.

The nipple portion 12 illustrated in FIGS. 1 and 2 include a plurality of ducts16. Any number of ducts 16 may be used, including just one. The ducts 16 arelongitudinal (axial) passageways formed in the material of the nipple 12. Each ductincludes an inner opening 18 in communication with an inner chamber 20 of thenipple 10. Each duct includes an outer opening 22 that is open to the exterior of thenipple. Fluid may flow from chamber 20, into inner openings 18, through ducts 16and out through outer openings 22. In an alternate embodiment, the outer openings22 may include valve devices 23 (FIG. 1A), the function of which is at least in part tocontrol, reduce or prevent passage of fluid therethrough in certain circumstances. A flange-like skirt or transitional member 24 extends generally radially fromthe nipple portion 12 to an upper annular surface 26 of the mounting portion 14.

The main body 28 of the mounting portion 14 may be formed of a gently concavecylinder 30, although this concavity is not required. A lower part 32 of the mountingportion 14 includes an inner lip 34 and a lower lip 36 with an inner groove 38 defined therebetween. The lower part 32 may be elastically deformed so as to be received on a container (not shown) and wherein the inner groove 38 is fitted over acorresponding mating feature on the container as in a snap-fit, screw attachment,and so on.

The nipple 10 may be formed as a single unitary part, or joined together fromtwo or more parts. In this illustrated first embodiment, the nipple 10 is formed of twoparts by a scarf-type joint 40. Adhesive bonding, heat bonding, chemical bonding, contact molding, ultrasonic welding or any suitable method may hold the joint 40 together. It will be understood that any suitable method of forming the nipple 10 may be employed, such as molding, casting, or two-shot molding, for example. FIG. 2 illustrates one embodiment of an arrangement of the ducts 16. Theducts 16 number six individual ducts, although any suitable number of ducts iscontemplated. The ducts are arranged in a triangular pattern, each vertice of thetriangle similarly spaced from a middle or central axis of the nipple. Two ducts 1601804012\105-01 9 188328/4 27.6.06 comprise a set and are positioned so as to be arranged axially outwardly in a linefrom the central axis. Other arrangements of ducts are contemplated thateffectively convey fluids through the nipple 10; this is just one such. As discussedabove, the ducts 16 may terminate with a round hole, slit, chisel, “S”-shaped aperture or “Y”-shaped aperture (not shown), for example, or any suitable terminalaperture shape. The termination of the ducts, whether a slit or other shape, mayfunction as a valve. FIG. 3 shows another embodiment of the present invention. In the illustratedembodiment, the nipple 110 is formed of a two-part construction. The nipple portion 112 includes a substantially solid nipple end 113, which extends to a hollow, dome-shaped body 115. The nipple portion 112 is similar to that described above, i.e., a substantially solid nipple body including a plurality of ducts 116 extendingtherethrough. The body 115 flares outward from the base of the nipple 112 and connects to a collar 142 for connecting to a bottle (not shown). FIG. 4 shows one embodiment of a collar 142 according to the present invention. The collar 142 here is formed of a rigid plastic material. The collar 142includes an annular sidewall 144. A mounting ring 146 is positioned at a top end148 of the collar 142. The mounting ring 146 is formed radially inwardly form thesidewall 144 and includes a foraminous configuration 150. The configuration 150 isformed of a latticework defining openings 152 therebetween. The configuration 150 may be formed of a plurality of closely spaced openings 152 or any suitable methodof providing passageways through the material of the collar. The openings 152 of the configuration 148 are provided so as to permit material of the body 115 topenetrate through the mounting ring 146 and become securely affixed thereto inmanufacture. An inner surface 154 of the collar 142 may include a device for fastening the collar 142 to a bottle, such as, for example, a set of threads 156 (seeFIGS. 5, 6, 7 and 8).

Referring to FIG. 7, this view of the embodiment of the artificial nipple 110 of the present invention details the attachment of the nipple body 115 and collar 142.

In particular, a lower end 158 of the nipple body 115 is positioned by molding, casting or the like so as to be intermingled or extended through the openings 152 ofthe mounting ring 146. As a result, a lowermost surface 160 (and see FIG. 8) iscreated on the lower end 158, which is oriented downwardly and positioned so as tosealingly engage a corresponding surface of a nursing bottle, container or the like. 01804012\105-01 10 188328/4 27.6.06 A vent 162 is shown in FIG. 7, for instance. As noted, the lower end 158 ofthe body 115 is joined to the collar 142. A horizontal passageway 164 is formedthrough the sidewall material of the nipple body 115. The passageway 164 is opento atmosphere at an outside end, and communicates at an inside end with a verticalpassageway or air inlet 166 (FIG. 8). The vertical passageway 166 is in communication with inner chamber 120 of the nipple body 115. FIG. 8 shows the nipple described in FIG. 3 from a bottom perspective view.The vertical passageway 166 is open to the inner chamber 120. Also, the sealingsurface 160 is shown generally at a position whereby the nipple portion 112 joinsthe collar 142. FIG. 9 shows an embodiment of the artificial nipple 210 of the presentinvention wherein the nipple portion 212 is offset with respect to a centerline “C”drawn along the center axis of the collar 242. This embodiment positions the nipplelower compared to the fluid level in the bottle. This helps to position the bottle sothat milk, instead of air, is at the ducts. It also can improve positioning for feeding.Also, a vent may be positioned on an opposite side from the nipple ducts so as tobe higher when in use and thus, properly venting. FIG. 10 shows still another embodiment of an artificial nipple according to thepresent invention. The nipple, illustrated generally at 310, is intended for use with acontainer, such as a bottle or bag. As in the above-described examples, the nipple310 may be made of any suitable material, but in a preferred form is made of a silicone material, such as silicone rubber.

The nipple 310 may be formed of two subparts including a substantially solidnipple portion 312 at an upper or proximal end thereof for insertion into an infant'smouth and for conveying fluids therethrough from an attached container (not shown)and a lower or distal end including a mounting portion 314 for attachment to the container.

The nipple portion 312 is a generally cylindrical and substantially solid body.Again, the material of which the nipple portion 312 is fabricated is of a Durometer A(or Shore A) hardness that is substantially within the previously described preferredrange. Of course, other shapes besides cylindrical can be used, such as orthodontic-type nipples, and so forth.

The nipple portion 312 includes a plurality of ducts 316 (see FIG. 12). The ducts 316 are longitudinal (axial) passageways formed in the material of the nipple 312. Each duct includes an inner opening 318 in communication with an inner 01804012\105-01 11 188328/4 27.6.06 chamber 320 of the nipple 310. Each duct 316 includes an outer opening 322 thatis open to the exterior of the nipple. The ducts 316 may be arranged as shown inFIG. 2 or, in the alternate as shown in FIG. 12, or any suitable effectivearrangement which takes into account the nipple 312 material and other factorssuch as the length of the ducts through the nipple, and the amount of flow throughdesired.

During use, fluid may flow from chamber 320, into inner openings 318,through ducts 316 and out through outer openings 322. In an alternate embodiment, the outer openings 322 may include valve devices (not shown in thisversion, but see, for instance, FIGS. 16A-16C and related discussion thereof).

As shown in FIGS. 10 and 11, the second subpart or mounting portion 314extends from and is attached to the nipple portion 312. The mounting portion 314 isattachable to a container in a secure, fluid-tight matter. The material of mounting portion 314 is fabricated of a material that may be of about the same or a greaterDurometer hardness than nipple portion 312. Here, the mounting portion 314 has aDurometer A hardness that is within the range of about 1 to about 100. Morepreferably, the material of the mounting portion 314 has a Durometer A hardnessthat is substantially within the range of about 20 to about 90. It will be understoodthat the mounting portion should have a Durometer A hardness sufficient to enablesecure and leak-free attachment to a container. Sandblasting the mold for themounting portion 314 to provide a matte-type finish for the molded piece in thethreaded area is useful for reducing friction when screwing the nipple on acontainer.

The nipple portion 312 extends into a dome-like structure to form skirt 370 ata lower portion thereof. An inner face 372 of the skirt portion 370 overlaps and connects to an outer face 374 of a corresponding upper engaging section 376 of themounting portion 314. Adjacent and below the upper engaging section 376 of themounting portion 314, and shown in more detail in FIG. 11, is an inner lip 378positioned radially inboard from a generally horizontal land 380, which, with inner wall 382, define a generally open channel 384 for sealingly engaging with acontainer such as a top of a bottle (not shown). The inner wall 382 may be providedwith a thread feature 386 to engage a corresponding feature on the container. The thread feature 386 may be a single raised thread as shown, or any suitablenumbers of threads for engagement with the container. Furthermore, the horizontal 01804012\105-01 12 188328/4 27.6.06 land 380 and inner lip may include a channel 381a and 381b formed therein which functions as a vent.

Channel 381a and 381b is also shown in FIG. 11A. It has a radial part 381athat extends across the land 380 from the inner sidewall 382 to the inner lip 378.While inner lip 378 is relatively thin in its radial dimension, channel part 381b is nonetheless formed therein on its outboard facing side and mates with the inside wall of the bottle. This vent structure 281b does not appreciably change whether the nipple is screwed on with a small or a larger force. Radial channel part 381a isdeep enough that it can be compressed without affecting venting.

The dome-like structure of skirt portion 370 has a lower rim section 394. Inone embodiment, the low Durometer material of the nipple portion 312 extends tothe lower rim 394. Alternatively, the lowest Durometer material stops at the bottomof the skirt 370. The flexibility of the nipple 310 and its general exterior softness canthus be suitably modified in this simple manner. A retaining ring 388, preferably made of a rigid plastic, may be positionedabut the outer peripheral surface 390 of the mounting portion 314. The retainingring 388 reinforces the mounting portion 314 over the thread feature 386, therebyassisting the mating of the thread feature 386 with the container, and prevents themounting portion 314 from flexing outwardly when being attached thereto. The retaining ring 388 is held in place at least in part by a bead 392 formed at the rim section 394 of mounting portion 314. The ring 388 can advantageously be color coded to indicate a feature of the nipple 312, such as where a plurality of nipples are available in different shapes, flow rates, softness and so forth. Other differentiating indicia may be used besides color-coding, of course.

In this illustrated embodiment, the nipple 310 is formed from nipple portion312 and mounting portion 314 by co-molding, adhesive bonding, heat bonding,chemical bonding, casting or any suitable method to unite the two. Again, the moldin which the present invention is molded may be sandblasted in order to produce aheavy matte finish on the nipple. In this manner, friction is reduced when screwingthe nipple onto a container. This is particularly advantageous in a mounting portionmade of silicone rubber or similar elastomer.

Turning to FIG. 13, another embodiment of the present invention is shown toillustrate a set of dimensions of a preferred nipple. It will be understood that thedimensions, lengths, widths, radii, and so on as provided herein are changeableaccording to a number of variables related to the material used to form the nipple,01804012\105-01 13 188328/4 27.6.06 the intended end user, manufacturing, flow and other factors. The provided dimensions are intended to illustrate a preferred embodiment and are not intended to be limiting. Structurally and dimensionally, the nipple 410 shown in FIG. 13 is similar to that shown in FIG. 10, and therefore these dimensions may be beneficiallyapplied to the nipple shown and described in FIG. 10, for example, as well as otherembodiments.

As above, the nipple 410 includes a nipple portion 412 and a mountingportion 414. Preferably, the nipple portion 412 is made of a platinum cured orsimilar silicone rubber having a Shore A hardness in the ranges previously indicated. The nipple portion 412 of the nipple 410 has an insertable axial length ofabout 23 mm, a greater diameter of 13.5 mm and a lesser diameter of 11.8 mm. Attimes the suckling infant may also insert more of the nipple than just the first 23 mmof nipple portion 412 and may also insert some or even all of the skirt 470. The overall length of the nipple portion is 40.3 mm. It will be noted that the flexibility, and extensibility of this transition area between the elongated nipple portion and themounting base, is very like that of the areola of the mother. Like the elongatednipple itself, the skirt 470 area stretches and elongated in the month.

The duct 422, formed in the nipple portion 412 is formed by a 21.8 mm pin ina molding process using platinum cured silicone rubber as the molded nipplematerial. The duct 422 is 1.1 mm in diameter. There may be more than one duct422.

The mounting portion 414 is made of a silicone rubber having a Shore Ahardness of 80. The depicted embodiment differs from that shown in FIG. 10, inthat, an annular peripheral channel 498 is formed about the mounting portion for aretaining ring (not shown, e.g., ring 388). The width of the mounting portion reaches45.6 mm. Other features of this nipple are the same as those described, and setout in FIG. 10.

Turning to FIG. 14, the nipple portion 512 includes a duct 522 with a modifiedterminal aperture 591. The cylindrical duct is 1.1 mm in diameter. The terminalaperture 591 is round in cross section and 0.15 mm in diameter.

The nipple portion 612 depicted in FIG. 15 has another embodiment of a modified terminal aperture or terminus 691, which is chisel shaped to provide a slit- shaped opening. In this manner, the terminal aperture 691 may beneficially function to prohibit unintended flow through the nipple and other beneficial flow characteristics. 01804012\105-01 14 188328/4 27.6.06 FIG. 16A shows another variation on a nipple end structure wherein the duct 16 (or indeed any of the other ducts described herein) has a generally cylindricalinternal cavity terminating in a small diameter outlet 692. FIG. 17B shows an end-view of such a structure. FIG. 16B shows a chisel-shaped terminus for the duct 16, with opposed sidewalls 692a and 692b which end in a slit 693, the latter shown in end-view in FIG. 17A. FIG. 16C is yet another terminus structure for the nipple duct 16, this alsohaving a chisel-shape 692a and 692b ending in a slit 693. Outboard sidewalls 694a and 694b defined within a well 695 give this structure a duck-bill configuration.

All of these terminal structures in FIGS. 16A-16C, and indeed the inboardend structure of FIG. 1A, serve as valves for allowing fluid flow out through the nipple, but generally (or substantially completely in certain structures) preventingflow back into the nipple. FIG. 18 shows still another embodiment of an artificial nipple according to thepresent invention. The nipple, illustrated generally at 710, is intended for use with acontainer, such as a bottle or bag. As in the above-described examples, the nipple 710 may be made of any suitable material, but in a preferred form is made of asilicone material, such as silicone rubber.

The nipple 710 may be formed of two general portions, namely a substantially solid nipple portion 712 at an upper or proximal end thereof forinsertion into an infant's mouth and for conveying fluids therethrough from anattached container (not shown) and a lower or distal end including a mountingportion 714 for attachment to the container.

The nipple portion 712 is preferably a generally cylindrical and substantiallysolid body. The material of which the nipple portion 712 is preferably fabricated isof a low Durometer A (or Shore A) hardness in the preferred range of about 0 to 45.Of course, other shapes besides cylindrical can be used, such as orthodontic-typenipples, and so forth.

The nipple portion 712 includes a plurality of ducts 716. The ducts 716 arelongitudinal (axial) passageways formed in the material of the nipple 710. Each duct includes an inner opening 718 in communication with an inner chamber 720 of the nipple 710. Each duct 716 includes an outer opening 722 that is open to the exterior of the nipple 710. The ducts 716 may be arranged as shown or, in the alternate, any suitable effective arrangement. 01804012\105-01 15 188328/4

An embodiment of a reinforcing member 725 is disposed in the nipple 710.

The reinforcing member 725 is positioned in the nipple 710 and oriented axially about the ducts 716 in a close, but spaced configuration. Structurally, the reinforcing member 725 may be a number of configurations. The reinforcing member 725 shown includes an open, hollow cylinder or sheath of material.

The wall of the reinforcing member 725 may be solid or not solid. Forexample, the reinforcing member 725 may be cylindrical, woven or fibroid, mesh,knitted, interlaced strands of material, porous, strips, helical, spiral ribbed, and incross section may be round, wheel-shaped, spoke-shaped, ribbed or any suitableshape. The reinforcing member 725 may extend along the length of the ducts 716or along a portion of the length of the ducts.

The illustrated reinforcing member 725 may be woven polyester or nylon, forexample. Non-woven examples may be made of platinum cured silicone having arelatively higher Durometer than the surrounding material of the nipple portion 712.One embodiment includes a Durometer A of about 50.

The nipple 710 may be formed by co-molding, adhesive bonding, heatbonding, chemical bonding, casting or any suitable method to unite the two portions.The mold in which the present invention is molded may be sandblasted in order to produce a heavy matte finish on the nipple. This is particularly advantageous in a mounting portion made of silicone rubber or similar elastomer. FIGS. 19A and 19B show an extrusion, which when inserted into a nipple(See FIG. 18) functions as a reinforcing member 825. The reinforcing memberincludes a smooth cylindrical outer surface 827 and an inside surface 829 includinga plurality of helical ribs 831. Of course, while five ribs 831 are shown, other numbers of ribs may be used. The ribs 831 may be non-helical. In this embodiment, the reinforcing member 825 is positioned in a nipple such that all of the ducts pass through the interior of the reinforcing member. Other examples include ducts passing outside of the reinforcing member. FIG. 20 shows an alternate embodiment of a reinforcing member 925wherein the cross sectional shape of the member is generally star-shaped with fiveradiating arms or walls 933. Ducts 916 of the nipple (not shown) are interposed between adjacent walls 933. One embodiment of the invention includes ducts 916Aformed closely adjacent the walls 933 and another embodiment of the invention isshown wherein the ducts 916B are formed near or outboard of the terminus of the 01804012\105-01 16 188328/4 walls. In this example of the invention, the reinforcing member 925 is positioned along the central axis of the nipple. FIG. 21 shows yet another embodiment of a reinforcing member 1025 which generally takes the form of a wheel with spokes. The outer surface 1027 may be a smooth cylinder, which surrounds a central hub 1035. Connecting the hub 1035 and outer surface 1027 are a number of spokes 1033 which define channels 1037 therebetween. Ducts 1016 are formed in the nipple material in the channels 1037. FIG. 22 shows a reinforcement member 1125 similar to the embodimentshown in FIG. 19A and 19B. The reinforcement member 1125 is generally a hollow,cylindrical shape disposed in a nipple portion 1112 of a nipple. Ducts 1116 are formed through the nipple portion 1112 inside the reinforcement member 1125.

Interior helical ribs 1131 are formed on the inside of the reinforcement member 1125. Exterior helical ribs 1139 are formed on the outside of the reinforcement member 1125. FIG. 23 shows a bottom view of a nipple 910 including the embodiment of areinforcing member 925 shown in section in FIG. 20. The bottom section 914 of thenipple 910 is shown wherein the ducts 916 are positioned between adjacent walls 933 of the reinforcing member 925. 01804012\105-01 17