Artificial nipples

Abstract

The artificial nipple includes a nipple body and a network. The nipple body has a base and a mouth extending longitudinally from the base. The nipple body has a proximal end face at the base and a distal end face disposed opposite the mouth. The network includes a plurality of fluid passageways extending between a plurality of inlet openings located at or adjacent the proximal end face and a single outlet opening located at or adjacent the distal end face.

Description

[Technical Field]

[0001] Related Applications This application claims priority to U.S. Provisional Patent Application No. 63 / 431,776, filed December 12, 2022, the entire subject matter of which is incorporated herein by reference. government funding This invention was made with government support under HD105294 awarded by the National Institutes of Health. The government has certain rights in this invention.

[0002] The present disclosure relates to an artificial nipple, and also to a baby bottle including a container and an artificial nipple fixed to the container. [Background technology]

[0003] Infant feeding is a complex behavior that requires both the ability to suckle and the ability to transport and swallow. Understanding the mechanisms behind these tasks can be challenging due to the complexity of infant feeding and the vulnerability of infants, especially those with medical conditions. While many artificial nipples are commercially available, most (if not all) of them are designed as milk-filled troughs, lacking a ductal system that allows direct release from the artificial nipple into the infant's mouth. While this system is found in cows, the human breast is composed of a series of ducts that release milk from multiple mammary glands within the breast. This makes breastfeeding and bottle-feeding mechanically different, and infants often have difficulty introducing breast milk or, conversely, reject the bottle after exclusive breastfeeding. Summary of the Invention

[0004] In one aspect, alone or in combination with any other aspect, there is provided an artificial nipple. The artificial nipple may include a nipple body. The nipple body may have a base and a mouth extending longitudinally from the base. The nipple body may have a proximal end face at the base and a distal end face disposed opposite the mouth. The artificial nipple may also include a network. The network may include a plurality of fluid passageways extending between a plurality of inlet openings disposed in the proximal end face and a single outlet opening disposed in the distal end face.

[0005] In one aspect, alone or in combination with any other aspect, there is provided an artificial nipple. The artificial nipple may include a substantially solid nipple body. The nipple body may have a base and a mouth extending longitudinally from the base. The nipple body may have a proximal end face at the base and a distal end face disposed opposite the mouth. A plurality of fluid passageways may each extend longitudinally from an inlet opening disposed in the proximal end face to an outlet opening disposed in the distal end face.

[0006] These and other features of the present disclosure will become apparent to those skilled in the art to which the present disclosure pertains upon reading the following description and upon reviewing the accompanying drawings. [Brief explanation of the drawings]

[0007] [Figure 1a] FIG. 1 is an exploded side view of a baby bottle according to one aspect of the present disclosure. [Figure 1b] 1b is a perspective side view of the baby bottle of FIG. 1a in an assembled state. FIG. [Figure 2] 2 is a cross-sectional view of a portion of the baby bottle of FIGS. 1a and 1b taken along line 2-2 of FIG. 1b, including an artificial nipple for the baby bottle in a first configuration. [Figure 3] FIG. 3 is a top view of the artificial nipple of FIG. 2. [Figure 4] 3A-3C show exemplary performance-based test results for the trough-shaped artificial nipple and the artificial nipple of FIG. 2. [Figure 5] 3 is a cross-sectional view showing an alternative configuration of the baby bottle of FIG. 2. FIG. [Figure 6]3 is a cross-sectional view showing another alternative configuration of the baby bottle of FIG. 2. FIG. [Figure 7] FIG. 1 is a schematic diagram of a network of artificial nipples configured in accordance with another aspect of the present disclosure. [Figure 8] FIG. 8 is a perspective view of the artificial nipple of FIG. 7. [Figure 9] FIG. 9 is a bottom view of the artificial nipple of FIG. 8. [Figure 10] FIG. 10 is a schematic diagram of another network of artificial nipples configured in accordance with another aspect of the present disclosure. [Figure 11] FIG. 11 is a top view of the network of FIG. [Figure 12] FIG. 11 is a bottom view of the network of FIG. 10. [Figure 13] FIG. 11 is a side view of an artificial nipple configured with the network of FIG. 10. [Figure 14] FIG. 14 is a side view showing the baby bottle with the artificial nipple of FIG. 13. [Figure 15] 14 is a side view of a baby bottle having an alternative configuration of the artificial nipple of FIG. 13. FIG. [Figure 16] FIG. 16 is a schematic diagram of an exemplary network mold structure used in the construction of the artificial nipple of FIG. 15. [Figure 17] 6 is a graph showing growth and efficiency-based test results of the trough-shaped artificial nipple and the artificial nipple of FIG. 5, showing that when fed ad libitum, infants fed with a ducted nipple can reach higher weights than infants fed with a cisternic nipple. [Figure 18] 6 is a graph showing performance rates from feeding-based tests of the bath-shaped artificial nipple and the artificial nipple of FIG. 5, showing that infants fed with a bath-shaped nipple and a tubular nipple have different sucking and swallowing rates than infants fed with a tubular nipple and infants fed with a bath-shaped nipple and a tubular nipple. [Figure 19]6 is a graph showing the physiology of feeding-based test results for the bath-type artificial nipple and the artificial nipple of FIG. 5, showing that 21-day-old (approximately 8 months in humans) infants fed with bath-type nipples were less able to feed with a tubular nipple than with a bath-type nipple, had less ability to suckle than infants fed with a tubular nipple, and that infants fed with a tubular nipple were less likely to experience aspiration than infants fed with a bath-type nipple, particularly when feeding with a tubular nipple. [Figure 20] 14 is a graph showing that pigs reared with bath teats generally achieved full attachment later than pigs reared with tubular teats (such as the artificial teat of FIG. 13). [Figure 21] This graph shows that pigs raised on bath nipples developed less oral suction throughout ontogeny than pigs raised on tubular nipples (such as the artificial nipples in Figure 13) (p<0.0001, Cohen's d>1), that pigs raised on tubular nipples acquired greater oral suction earlier in ontogeny than pigs raised on bath nipples, and that at 28 days of age, both groups of pigs developed similar oral suction. [Figure 22] 12 is a graph showing that pigs reared with trough teats consumed milk faster throughout ontogeny than pigs reared with tubular teats (such as the artificial teats in FIG. 13) (p<0.005), and that pigs reared with trough teats had higher feeding rates throughout ontogeny than pigs reared with tubular teats (p<0.0001). [Figure 23] 12 is a graph showing that at 28 days of age, pigs fed with trough teats retracted their teats more than pigs fed with tubular teats (such as the artificial teats in FIG. 13 ) (p<0.001, Cohen's d>1), and pigs reared with trough teats retracted their teats more than pigs reared with tubular teats (p<0.001, Cohen's d>0.8). [Figure 24] FIG. 1 is a graph showing that at 28 days of age, oral sucking occurred in all pigs (p>0.05), regardless of the type of teat they were raised on or the type of teat they were fed from. [Figure 25]14 is a graph showing that at 28 days of age, pigs fed with trough teats consumed milk faster (p<0.0001, Cohen's d>0.9) than pigs fed with tubular teats (such as the artificial teats in FIG. 13). DETAILED DESCRIPTION OF THE INVENTION

[0008] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains.

[0009] As used herein, the term "subject" can refer to any mammal (e.g., humans, monkeys, apes, dogs, cats, pigs, livestock, and domestic animals).

[0010] As used herein, the singular forms "a," "an," and "the" can also include the plural forms unless the context clearly dictates otherwise. Furthermore, as used herein, it will be understood that the terms "comprise" and / or "comprising" may specify the presence of stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof.

[0011] As used herein, the term "and / or" may include any and all combinations of one or more of the associated listed items.

[0012] As used herein, expressions such as "between X and Y" may be interpreted to include X and Y.

[0013] When an element is referred to as being "on," "connected to," "contacting," or the like, to another element, it is understood that the element can be directly mounted, connected, or in contact with the other element, or that intervening elements may be present. In contrast, for example, when an element is referred to as being "directly contacting" another element, no intervening elements are present. Additionally, those skilled in the art will appreciate that a reference to a structure or feature being disposed "adjacent" to another feature may not have overlapping portions either above or below the adjacent feature.

[0014] It is understood that the use of terms such as "first," "second," etc. herein may refer to various elements, but these elements should not be limited by these terms. These terms are merely used to distinguish one element from another. Thus, a "first" element described below could also be referred to as a "second" element without departing from the teachings of the present disclosure. The order of operations (or steps) is not limited to the order presented in the claims or drawings unless specifically specified otherwise.

[0015] The "predetermined" state may be determined at any time before the structure being manipulated actually reaches that state, with the "predetermination" being set only just before the structure achieves the predetermined state.

[0016] As used herein, the term "substantially" denotes a quality that is largely, but not necessarily completely, specified, and a "substantial" quality allows for the possibility of relatively small deviations from that quality.

[0017] Two or more elements described as being in "fluid communication" and / or "fluidically connected" with each other are understood to be arranged so that fluid can flow directly from one of the elements to at least one of the other elements, as needed, or from one of the elements to at least one of the other elements through one or more intervening elements. In contrast, two or more elements described as being in "direct fluid communication" and / or "directly fluidically connected" with each other are arranged so that fluid can flow directly from one of the elements to at least one of the other elements, as needed, without passing through any intervening elements.

[0018] The present disclosure may comprise, consist of, or consist essentially of the following features in any combination:

[0019] The present disclosure relates to an artificial nipple 100 (FIGS. 1a and 1b) that may form part of a baby bottle 102. FIGS. 1a and 1b illustrate an exemplary configuration of the baby bottle 102. As shown in FIGS. 1a and 1b, the baby bottle 102 includes a container 104 having an internal cavity 106 and a container opening 108 in fluid communication with the internal cavity 106. The internal cavity 106 is configured to selectively hold a predetermined amount of fluid (e.g., a liquid such as milk, water, a therapeutic liquid (e.g., saline), any other desired liquid, or any combination thereof). The container 104 also includes a longitudinally opposed container rim 110 extending circumferentially around the container opening 108. As used herein, the term "longitudinal" refers to a vertical or substantially vertical direction in the orientation of FIGS. 1a and 1b, and is designated LO in FIGS. 1a and 1b.

[0020] The artificial nipple 100 is configured to be selectively secured to a container 104. The artificial nipple 100 is designed to more closely mimic the physiology and behavior of a breast-fed infant than a trough-like artificial nipple. Thus, while a trough-like artificial nipple is essentially a hollow tube that fills with milk, the artificial nipple 100 of the present disclosure is substantially solid, with multiple fluid passageways (i.e., tubes) extending therethrough. The general consensus regarding infant feeding is that "breast milk is best" from a biomechanical and nutritional standpoint. However, not all mothers are able or willing to exclusively breastfeed, and as an alternative, they may need to use a combination of breast milk and a bottle, or rely solely on a bottle. Mothers often face challenges when introducing a bottle after breastfeeding, or introducing breast milk after bottlefeeding, due to differences in nipple configuration. The artificial nipple 100 is intended to address these challenges by more accurately mimicking the material properties of the breast. Additionally, many known artificial nipples provide feeding physiology more similar to drinking from a cup than breastfeeding, resulting in reduced electromyographic ("EMG") activity in the neck and tongue muscles, with corresponding potential consequences. For example, breastfed infants have better speech-language outcomes than bottle-fed infants, even at age 5. Additionally, oxygen saturation levels, autoregulation, and swallowing-breathing coordination are all believed to be superior in breastfeeding compared to bottle-feeding. Artificial nipple 100 is intended to mitigate these differences.

[0021] The artificial nipple 200 of FIG. 2 is an exemplary configuration of the artificial nipple 100 shown in FIGS. 1a and 1b, designed in accordance with the present disclosure. As shown in FIG. 2, the artificial nipple 200 includes a nipple body 212 having a base 214 and a mouth 216 extending longitudinally from the base 214 relative to a central longitudinal axis 217 of the artificial nipple 200. The base 214 is configured to be adjacent to the receptacle 104, while the mouth 216 is configured to be inserted at least partially into a subject's oral cavity (e.g., the oral cavity of a human infant). During use of the artificial nipple 200, at least a portion of the subject's lips may contact a portion of the base 214. In such cases, the base 214 may have a larger lateral diameter than the mouth 216. The term "lateral" is used herein to indicate a direction perpendicular or substantially perpendicular to the "longitudinal" direction, and is designated LA in FIG. 2. 2, the base 214 may have a substantially hemispherical shape, while the mouth 216 may be substantially frustum-shaped. The nipple body 212 also has a proximal end face 218 at the base 214 and a distal end face 220 disposed longitudinally opposite the proximal end face 218 at the mouth 216.

[0022] The artificial nipple 200 includes multiple fluid passageways 222. While Figures 2 and 3 show the artificial nipple 200 as having three fluid passageways 222, the artificial nipple 200 may include two or more fluid passageways 222. Each fluid passageway 222 extends longitudinally relative to the central longitudinal axis 217 of the artificial nipple 200 from an inlet opening 224 located at the proximal end face 218 to an outlet opening 226 located at the distal end face 220.

[0023] As shown in FIG. 2 , the nipple body 212 is substantially solid. By “substantially solid,” we mean that the nipple body 212 is solid from the proximal end surface 218 to the distal end surface 220, except for the inclusion of the fluid passageways 222. In other words, the nipple body 212 has a completely solid volume except for the volume defined by each of the fluid passageways 222. As noted above, the artificial nipple 200, being substantially solid and including multiple fluid passageways 222, more closely mimics the physiology and structure of the mammary gland (human or otherwise) than a trough-shaped artificial nipple. Furthermore, the nipple body 212 may be formed by injection molding or any other suitable process from a material that mimics the biological properties of the mammary gland (human or otherwise). This material may be, for example, silicone (e.g., food-safe silicone rubber), any other suitable material, or any combination thereof.

[0024] In some examples, the shape of the nipple body 212 is based on the anatomy of the porcine mammary gland. In other examples, the shape of the nipple body 212 is based on the anatomy of the mammary gland of any other mammal, such as the human mammary gland.

[0025] The artificial nipple 200 also more closely mimics the behavior of a breast-fed infant than a bath-like artificial nipple. For example, the first and second graphs G1 and G2 in FIG. 4 show the pressure and genioglossus muscle test results of the artificial bath (first graph G1) compared to those of the artificial nipple (second graph G2). As shown in FIG. 4, the pressure generation in second graph G2 is nearly twice that shown in first graph G1, the genioglossus EMG activity is also much higher in second graph G2 than in first graph G1, and the rhythmicity of pressure generation is better in second graph G2 than in first graph G1. These results are particularly encouraging because the pressure generation is greater and the EMG firing amplitude is higher in breast-fed infants than in infants fed with a bath-like artificial nipple.

[0026] As shown in Figures 1 and 2, the artificial nipple 200 may be selectively secured to the container via a collar 128. The collar 128 includes a collar base 130 having opposing inner and outer collar surfaces 132 and 134. The inner collar surface 132 includes internal threads 136 configured to threadably mate with external threads 138 on the outer surface 140 of the container 104 to secure the collar 128 to the container 104. As shown in Figures 1 and 2, the external threads 138 of the container 104 are positioned adjacent to the container opening 108.

[0027] The collar 128 also includes a collar flange portion 142 extending laterally inward from the collar base 130 toward the central longitudinal axis 244 of the bottle 102. As shown in FIG. 2, the central longitudinal axis 217 of the artificial nipple 200 may be coaxial with the central longitudinal axis 244 of the bottle body, although these axes 244 may be at least partially laterally offset from one another. When the artificial nipple 200 is secured to the container 104, the external flange 246 of the artificial nipple 200 is longitudinally disposed between the collar flange portion 142 and the container rim 110 and is held in such orientation by compressive forces. The external flange 246 may be a partially or fully annular flange extending laterally outward from the central longitudinal axis 244 from the base 214 of the artificial nipple 200. When the artificial nipple 200 is secured to the container 104, a portion of the external flange 246 and / or a portion of the base 214 may directly contact the container rim 110. Alternatively, a portion of the external flange 246 and / or a portion of the base 214 may be in direct contact with an intermediate portion of the bottle, which portion may be positioned longitudinally between the container rim 110 and the artificial nipple 200, separate from both the artificial nipple 200 and the container 104.

[0028] The secured artificial nipple 200 is positioned such that the inlet opening 224 is axially aligned with the container opening 108 and fluidly connects the internal cavity 106 to the fluid passageway 222. With this configuration, when the subject applies inhalation, fluid is drawn from the internal cavity 106 into the fluid passageway 222, through the fluid passageway 222, and into the subject's oral cavity through the outlet opening 226. Although the artificial nipple 100 has been described as being secured and retained to the container 104 by the collar 128 and compressive force, the artificial nipple 200 may be secured and / or retained to the container 104 in any other desired manner.

[0029] 2, each fluid passage 222 extends linearly in the longitudinal direction such that the transverse diameters of the inlet opening 224, the fluid passage 222, and the outlet opening 226 are all the same. Furthermore, the transverse diameter of each fluid passage 222 is the same as each of the other fluid passages 222. This is merely one exemplary configuration of the fluid passages 222. The fluid passages 222 may have any other desired shape.

[0030] Figures 5, 6, 7-8, 10-14, and 15-16 illustrate other exemplary configurations of the artificial nipple 100 of Figures 1a and 1b, designed in accordance with the present disclosure. Because the artificial nipples 500, 600, 700, 1000, and 1500 of Figures 5, 6, 7-8, 10-14, and 15-16 are similar to the artificial nipple 200 of Figure 2, structures in Figures 5, 6, 7-8, 10-14, and 15-16 that are identical or similar to the structures described with reference to Figure 2 have been designated with the same reference numerals plus a prime symbol. The configurations of Figures 5, 6, 7-8, 10-14, and 15-16 are considered incorporated by reference below, where appropriate, instead of repeating a description of common elements and operations similar to those described above. Furthermore, any elements, features, structures, material compositions, and / or advantages illustrated or described with respect to one configuration may be shared by any other configuration, whether or not explicitly described or shown.

[0031] As shown in FIG. 5, the artificial nipple 500 may be configured such that each of the fluid passageways 222′ extends linearly longitudinally relative to the central longitudinal axis 217′ of the artificial nipple 500. However, instead of all of the fluid passageways 222′ having the same transverse diameter, the transverse diameter of at least one of the fluid passageways 222′ may be different (e.g., larger or smaller) than at least one of the other fluid passageways 222′. In the exemplary configuration of FIG. 5, the artificial nipple 500 includes at least one fluid passageway 222′ (designated 222a′) with a larger transverse diameter and at least one fluid passageway 222′ (designated 222b′) with a smaller transverse diameter. If desired, the artificial nipple 500 may be configured such that the transverse diameters of the fluid passageways 222′ are all different from one another, or such that only one of the fluid passageways 222′ has a different transverse diameter from the other fluid passageways 222′.

[0032] As shown in Figure 6, the artificial nipple 600 may be configured such that at least one of the fluid passageways 222' may be tapered between the inlet opening 224' and the outlet opening 226', rather than extending linearly between them. For example, as shown in the exemplary configuration of the artificial nipple 600 in Figure 6, each fluid passageway 222' tapers inwardly from the inlet opening 224' to the outlet opening 226' as it extends longitudinally relative to the central longitudinal axis 217' of the artificial nipple 600. In other words, the transverse diameter of the inlet opening 224' is larger than the transverse diameter of the outlet opening 226', and the transverse diameter of the fluid passageway 222' decreases as it extends longitudinally from the inlet opening 224' to the outlet opening 226'. Although the fluid passageways 222' are shown as having the same transverse diameter at each longitudinal location, at least one of the tapered fluid passageways 222' may have a larger or smaller transverse diameter than at least one of the other fluid passageways 222' at each longitudinal location. Additionally, although all of the fluid passageways 222' in Figure 6 are shown as tapered, the artificial nipple 100 may include at least one tapered fluid passageway 222 and at least one straight fluid passageway 222'.

[0033] The artificial nipple 700 comprises a network 748 and a nipple body 212'. As shown in FIGS. 7 and 8, the network 748 includes a plurality of fluid passageways 222' extending longitudinally (or "substantially" longitudinally, where relatively little deviation occurs due to the shape of the individual fluid passageways 222') relative to a central longitudinal axis 217' of the artificial nipple 700 between a plurality of inlet openings 224' and a single outlet opening 226'. As used herein, the term "substantially longitudinal" means "longitudinal plus or minus 10 degrees, preferably longitudinal plus or minus 5 degrees, and more preferably longitudinal plus or minus 1 degree." At least one of the passageways 222' may be at least partially straight, curved, arcuate, or otherwise shaped to aid in achieving or correspond to a desired shape of the nipple body 212'. The network 748 includes multiple layers 750 along the longitudinal length of the network 748 and, therefore, the artificial nipple 700 as a whole. Each layer 750 includes at least one fluid passageway 222' that is in direct fluid communication with at least two fluid passageways 222' of another layer 750.

[0034] As shown in the exemplary configuration of FIG. 7, the layer 750 may include four passage layers 750 (shown here as first through fourth layers 750a through 750d). The first layer 750a has eight fluid passages 222′. Each fluid passage 222′ in the first layer has a first end 752 in fluid communication with an associated one of the inlet openings 224′ and a second end 754. The second layer 750b has four fluid passages 222′. Each fluid passage 222′ in the second layer has a first end 752 in fluid communication with the second ends 754 of two adjacent fluid passages 222′ in the first layer 750a and a second end 754. The third layer 750c has two fluid passages 222′. Each fluid passage 222' in the third layer has a first end 752 in fluid communication with the second ends 754 of two adjacent fluid passages 222' in the second layer 750b, and a second end 754. The fourth layer 750d has one fluid passage 222'. The fluid passage 222' in the fourth layer has a first end 752 in fluid communication with the second ends 754 of the fluid passages 222' in the third layer 750c, and a second end 754 in fluid communication with a single outlet opening 226'. Thus, the number of fluid passages 222' between two adjacent layers 750 of the network 748 shown in FIG. 7 varies by a factor of two. However, the network 748 may have any number of fluid passages 222' in each layer, so long as they extend from multiple inlet openings 224' to a single outlet opening 226'.

[0035] The network 748 shown in Figure 7 is defined by a network structure 756. As shown in Figure 8, this network structure 756 is formed separately from the nipple body 212' and then at least partially surrounded by the nipple body 212' to form the artificial nipple 700. For example, the nipple body 212' may be overmolded onto the network structure 756.

[0036] 7, the network structure 756 may include a substrate 758. The substrate 758 has longitudinally opposed proximal and distal surfaces 760, 762. The substrate 758 may have at least one alignment opening 759 (shown here as multiple alignment openings 759) extending longitudinally through the substrate 758 from the proximal surface 760 to the distal surface 762. The use of the alignment openings allows the network structure 756 to be oriented in a desired manner and to maintain such desired orientation upon overmolding of the nipple body 212' onto the network structure 756.

[0037] The fluid passageways 222' extend longitudinally from the distal plate surface 762. As shown in FIG. 9 , the proximal plate surface 760, together with the proximal end surface 218' of the nipple body 212', can define a single, continuous proximal end surface 764 of the artificial nipple 700 when the network structure 756 is enclosed by the nipple body 212'. Thus, the inlet opening 224' is adjacent to the proximal end surface 218' of the nipple body 212' while extending longitudinally through the substrate 758 between the proximal plate surface 760 and the distal plate surface 762. Alternatively, the proximal plate surface 760 may be encapsulated in the nipple body 212' such that it is longitudinally offset from the proximal end surface 218' of the nipple body 212'. In this offset configuration, the inlet opening 224' is located at the proximal end surface 218' and extends through both a portion of the nipple body 212' and the substrate 758 to fluidly connect to the first end 752 of the first layer of fluid passageways 222'. The first layer 750 may be defined as the layer 750 of the fluid passageways 222' that is located longitudinally closest to the inlet opening 224'. Alternatively, the substrate 758 of the network structure 756 can be omitted. In this substrate-less configuration, the first end 752 of the first layer of fluid passageways 222' is in fluid communication with the inlet opening 224' located at the proximal end surface 218'.

[0038] As shown in FIG. 8 , the network structure 756 adjacent to the second end 754 of the fluid pathway 222′ in the final layer 750 may define a single, continuous distal end surface 766 with the distal end surface 220′ of the nipple body 212′ when the network structure 756 is surrounded by the nipple body 212′. The final layer 750 may be defined as the layer 750 of the fluid pathway 222′ that is disposed longitudinally farthest from the inlet opening 224′. Thus, the outlet opening 226′ may be formed by the network structure 756 while adjacent to the distal end surface 220′ of the nipple body 212′. Alternatively, the network structure 756 adjacent to the second end 754 of the fluid pathway 222′ in the final layer 750 may be encapsulated in the nipple body 212′ and longitudinally offset from the distal end surface 220′ of the nipple body 212′. In this offset configuration, the outlet opening 226' is located at the distal end surface 220' and extends through a portion of the nipple body 212' to be fluidly connected to the second end 754 of the final layer fluid passageway 222'.

[0039] Instead of the network 748 being defined by a separate network structure 756, the nipple body 212' may be formed with an internal shape that defines the network 748. Thus, the network 748 may be formed without including a separate structure from the nipple body 212' by selectively omitting portions of the nipple body material within the nipple body 212'. In this configuration, the fluid passageway 222' of the network 748 extends between an inlet opening 224' located at the proximal end surface 218' of the nipple body 212' and a single outlet opening 226' located at the distal end surface 220' of the nipple body 212'. This network-less artificial nipple 700 may be formed by injection molding, 3D printing, or any other suitable manner.

[0040] Regardless of whether the network 748 is defined by a separate network structure 756 or by the nipple body 212' itself, the nipple body 212' is substantially solid. By substantially solid, it is meant that the nipple body 212' is solid from the proximal end face 218' to the distal end face 220', except for the inclusion of the network 748. In other words, the nipple body 212' has a volume that is entirely solid except for the volume defined by the network 748.

[0041] The artificial nipple 700 of Figures 7 and 8 may be secured and retained to the container 104 by the collar 128 and compressive force. In such cases, the artificial nipple 700 may include an external flange (not shown in Figure 7). The external flange of the artificial nipple 700 may be a partially or fully annular flange extending laterally outward from the base 214' and / or substrate 758 of the nipple body 212'. However, the artificial nipple 700 may be secured and / or retained to the container 104 in any other desired manner. When the artificial nipple 700 is secured to the container 104, the inlet opening 224' is axially aligned with the container opening 108, fluidly connecting the internal cavity 106 to the first layer fluid passageway 222'.

[0042] The artificial nipple 1000 similarly comprises a network 748' and a substantially solid nipple body 212'. As shown in FIGS. 10-14, the network 748' includes a plurality of fluid passageways 222' extending substantially longitudinally relative to a central longitudinal axis 217' of the artificial nipple 1000 between a plurality of inlet openings 224' and a single outlet opening 226'. At least one of the passageways 222' may be at least partially straight, curved, arcuate, or otherwise shaped to aid in achieving or correspond to a desired shape of the nipple body 212'. The network 748' includes a plurality of layers 750' along the longitudinal length of the network 748' and, thus, the artificial nipple 1000 as a whole. Each layer 750' includes at least one fluid passageway 222' in direct fluid communication with a plurality of fluid passageways 222' of another layer 750'.

[0043] As shown in the exemplary configuration of FIGS. 10-14, a layer 750′ may include three passage layers 750′ (shown here as first, second, and third layers 750a′, 750b′, and 750c′). The first layer 750a′ has nine fluid passages 222′. Each fluid passage 222′ in the first layer has a first end 752′ in fluid communication with an associated one of the inlet openings 224′ and a second end 754′. The second layer 750b′ has three fluid passages 222′. Each fluid passage 222′ in the second layer has a first end 752′ in fluid communication with the second ends 754′ of three adjacent fluid passages 222′ in the first layer 750a′ and a second end 754′. The third layer 750c′ has one fluid passage 222′. The fluid passages 222' in the third layer have first ends 752' in fluid communication with second ends 754' of the fluid passages 222' in the third layer 750c and second ends 754' in fluid communication with a single outlet opening 226'. Thus, the number of fluid passages 222' between two adjacent layers 750' in the network 748' shown in Figures 10-14 varies by a factor of three. However, the network 748' may have any number of fluid passages 222' in each layer, so long as they extend from multiple inlet openings 224' to a single outlet opening 226'.

[0044] The network 748' shown in Figures 10-14 is defined by a network structure 756'. As shown in Figures 13 and 14, this network structure 756' is formed separately from the nipple body 212' and then at least a portion of the network structure 756' is surrounded by the nipple body 212' to form the artificial nipple 1000. For example, the nipple body 212' may be overmolded onto the network structure 756'.

[0045] As shown in FIG. 13 , the inlet openings 224' are located at or adjacent to the proximal end surface 218' of the nipple body 212'. For example, the network structure 756' adjacent to the first end 752' of the first layer of fluid pathways 222' may define a single, continuous proximal end surface 764' with the proximal end surface 218' of the nipple body 212' when the network structure 756' is enclosed by the nipple body 212'. Thus, the inlet openings 224' may be formed by the network structure 756' while adjacent to the proximal end surface 218' of the nipple body 212'. Alternatively, the network structure 756' adjacent to the first end 752' of the first layer of fluid pathways 222' may be encapsulated in the nipple body 212' and longitudinally offset from the proximal end surface 218' of the nipple body 212'. In this offset configuration, the outlet opening 226' is located in the proximal end surface 218' and extends through a portion of the nipple body 212' to be fluidly connected to the first end 752' of the first layer fluid passageway 222'.

[0046] The network structure 756' adjacent to the second end 754' of the fluid passageway 222' of the final layer 750 may define a single continuous distal end surface 766' with the distal end surface 220' of the nipple body 212' when the network structure 756' is surrounded by the nipple body 212'. Thus, the exit opening 226' may be formed by the network structure 756' while adjacent to the distal end surface 220' of the nipple body 212'. Alternatively, the network structure 756' adjacent to the second end 754' of the fluid passageway 222' of the final layer 750' may be encapsulated in the nipple body 212' and longitudinally offset from the distal end surface 220' of the nipple body 212'. In this offset configuration, the outlet opening 226' is located at the distal end surface 220' and extends through a portion of the nipple body 212' to be fluidly connected to the second end 754' of the final layer fluid passageway 222'.

[0047] 13 and 14, the artificial nipple 1000 may be secured and retained to the container 104 by the collar 128 and compressive force. In such cases, the artificial nipple 1000 may include an external flange 246' extending laterally outward from the base 214' of the nipple body 212'. However, the artificial nipple 1000 may be secured and / or retained to the container 104 in any other desired manner. When the artificial nipple 1000 is secured to the container 104, the inlet opening 224' is axially aligned with the container opening 108, fluidly connecting the internal cavity 106 to the first layer fluid passageway 222'.

[0048] As shown in FIGS. 15 and 16, instead of the network 748' being defined by a separate network structure 756', the substantially solid nipple body 212' may be formed with an internal shape that defines the network 748'. Thus, the network 748' of the artificial nipple 1500 may be formed without a separate structure (e.g., network structure 756') remaining on the interior and / or exterior of the nipple body 212' during use by selectively omitting portions of the nipple body material within the nipple body 212'. However, when forming the artificial nipple 1500 of FIG. 15, the nipple body 212' may be molded (e.g., overmolded) over a pre-formed network mold structure 1668. FIG. 16 shows an example of such a network mold structure 1668 (which is solid in this exemplary configuration). Thus, the network 748 defined by the internal shape of the nipple body 212' is formed by the space occupied by the network mold structure 1668. The network mold structure 1668 is removed after the nipple body 212' and its internal network 748' are formed. The artificial nipple 1500 may be configured / packaged such that this removal can be completed by the manufacturer, the user, and / or any other third party. Furthermore, the artificial nipple 1500 may be formed by injection molding, 3D printing, or any other suitable manner.

[0049] Although the artificial nipples 700, 1000, 1500 have been described and illustrated as having only one network 748, 748', at least one of the artificial nipples 700, 1000, 1500 may have multiple networks 748, 748'. In a multi-network configuration, each network 748, 748' may be at least partially surrounded by the nipple body 212'. Furthermore, each network 748, 748' includes multiple fluid passageways 222' extending between multiple inlet openings 224' and a single outlet opening 226' such that each network 748, 748' has its own separate inlet opening 224' and outlet opening 226'.

[0050] The exit opening 226, 226' of any of the artificial nipples 100, 200, 500, 600, 700, 1000, 1500 may be "center-cut" (so as to be circular or substantially circular, or rounded or substantially rounded) or "cross-cut" (so as to be "X" or substantially "X" shaped, or cross or substantially cross shaped). A "cross-cut" exit opening 226, 226' may be "open" when a predetermined amount of suction is applied.

[0051] Exemplary Embodiments In view of the described devices, methods, and variations thereof, certain more particularly described aspects of the present disclosure are set forth herein below, but these detailed recitation aspects should not be construed as having any limiting effect on any of the various claims incorporating the various teachings set forth herein or the more general teachings, or as being limited in any way other than by the inherent meaning of the expression "specific aspects" as used literally in each instance.

[0052] Aspect 1: An artificial nipple includes a nipple body and a network. The nipple body has a base and a mouth extending longitudinally from the base. The nipple body has a proximal end face at the base and a distal end face disposed opposite the mouth. The network includes a plurality of fluid passageways extending between a plurality of inlet openings located at or adjacent the proximal end face and a single outlet opening located at or adjacent the distal end face.

[0053] Embodiment 2: The artificial nipple of Embodiment 1, wherein the network comprises a plurality of layers along the longitudinal length of the artificial nipple, each layer comprising at least one fluid passageway in direct fluid communication with a plurality of fluid passageways in another layer.

[0054] Embodiment 3: The artificial nipple of Embodiment 1 or 2, wherein the network comprises a plurality of layers along the longitudinal length of the artificial nipple, each layer comprising at least one fluid passageway in direct fluid communication with three fluid passageways in another layer.

[0055] Embodiment 4: The artificial nipple of any of Embodiments 1-3, wherein the network comprises a plurality of layers along the longitudinal length of the artificial nipple, each layer comprising at least one fluid passageway in direct fluid communication with at least two fluid passageways in another layer.

[0056] Aspect 5: The artificial nipple according to any one of Aspects 1 to 4, wherein the number of fluid passages between two adjacent layers is varied by a factor of two or three.

[0057] Aspect 6: The artificial nipple of any of Aspects 1-5, wherein the layers are a first layer having eight fluid passageways, each fluid passageway in the first layer having a first end in fluid communication with an associated one of the inlet openings, and a second end; and a second layer having four fluid passageways, each fluid passageway in the second layer having a first end in fluid communication with the second ends of two adjacent fluid passageways in the first layer, and a second end. a third layer having two fluid passages, each fluid passage of the third layer having a first end in fluid communication with the second ends of two adjacent fluid passages of the second layer and a second end; and a fourth layer having one fluid passage, each fluid passage of the fourth layer having a first end in fluid communication with the second ends of the fluid passages of the third layer and a second end in fluid communication with a single outlet opening.

[0058] Aspect 7: An artificial nipple described in any of Aspects 1 to 5, wherein the layers include: a first layer having nine fluid passages, each fluid passage of the first layer having a first end fluidly connected to an associated one of the inlet openings, and a second end; a second layer having three fluid passages, each fluid passage of the second layer having a first end fluidly connected to the second ends of three adjacent fluid passages of the first layer, and a second end; and a third layer having one fluid passage, each fluid passage of the third layer having a first end fluidly connected to the second ends of the fluid passages of the second layer and a second end fluidly connected to a single outlet opening.

[0059] Aspect 8: An artificial nipple according to any one of Aspects 1 to 7, wherein the network is defined by a network structure that is formed separately from the nipple body and is at least partially surrounded by the nipple body.

[0060] Aspect 9: The artificial nipple according to any one of Aspects 1 to 8, wherein the nipple body is overmolded onto the network structure.

[0061] Aspect 10: An artificial nipple described in any of Aspects 1 to 7, wherein the network is formed by omitting a portion of the nipple body material inside the nipple body, without any separate structure remaining inside and / or outside the nipple body during use.

[0062] Embodiment 11: The artificial nipple according to any one of embodiments 1 to 10, wherein the nipple body is solid from the proximal end surface to the distal end surface, except that it includes a network.

[0063] Aspect 12: The artificial nipple according to any one of Aspects 1 to 11, wherein the nipple body has a completely solid volume other than the volume defined by the network.

[0064] Aspect 13: The artificial nipple according to any one of Aspects 1 to 12, wherein the nipple body has an external flange.

[0065] Aspect 14: The artificial nipple of any of Aspects 1-13, wherein the external flange is a partially or fully annular flange extending laterally outward from the base.

[0066] Aspect 15: An artificial nipple according to any of aspects 1 to 14, wherein the first end of the fluid passage of the first layer is in fluid communication with an inlet opening located on the proximal end face.

[0067] Aspect 16: An artificial nipple described in any of Aspects 1 to 9 and 11 to 15, wherein the network structure adjacent to the second end of the fluid passage of the final layer consisting of a fluid passage forms a single continuous distal end surface together with the distal end surface of the nipple body when the network structure is surrounded by the nipple body.

[0068] Aspect 17: The artificial nipple of any of Aspects 1-7 and 10-15, wherein the substantially solid nipple body is formed to have an internal shape that defines a network.

[0069] Aspect 18: An artificial nipple according to any of Aspects 1 to 7 and 10 to 17, wherein the substantially solid nipple body is formed without any separate structure remaining inside and / or outside the nipple body during use.

[0070] Aspect 19: In the artificial nipple according to any one of Aspects 1 to 7 and 10 to 18, when forming the artificial nipple, the nipple body is molded onto a preformed network mold structure. Therefore, the network defined by the internal shape of the nipple body is formed by the space occupied by the network mold structure. After the nipple body and its internal network are formed, the network mold structure is removed prior to use.

[0071] Aspect 20: The artificial nipple of any of Aspects 1-19, wherein the artificial nipple comprises a plurality of networks, each network having its own separate inlet and outlet openings, the networks comprising a plurality of fluid passageways extending between a plurality of inlet openings and a single outlet opening.

[0072] Aspect 21: The artificial nipple according to any one of Aspects 1 to 20, wherein each network is at least partially surrounded by the nipple body.

[0073] Aspect 22: The artificial nipple of any of Aspects 1-20, further comprising at least one additional network that is separate from (e.g., not in fluid communication and / or direct fluid communication with) the network. The at least one additional network comprises a plurality of additional fluid passageways extending between a plurality of additional inlet openings located at or adjacent the proximal end face and a single additional outlet opening located at or adjacent the distal end face.

[0074] Aspect 23: A baby bottle includes a container and the artificial nipple of any one of Aspects 1 to 22. The container has an internal cavity and a container opening in fluid communication with the internal cavity. The artificial nipple of any one of Aspects 1 to 22 is secured to the container such that the inlet opening is axially aligned with the container opening and fluidly connects the internal cavity to the fluid passage of the network.

[0075] Aspect 24: The baby bottle of aspect 23, further comprising a collar for securing the artificial nipple to the container.

[0076] Aspect 25: The baby bottle of aspect 23 or 24, wherein the collar includes internal threads configured to threadably engage with external threads on the exterior of the container to secure the collar to the container.

[0077] Aspect 26: A baby bottle according to any one of aspects 23 to 25, wherein when the artificial nipple is fixed to the container, the external flange of the artificial nipple is positioned longitudinally between the internal flange of the collar and the rim of the container, and is held in such position by compressive force.

[0078] Aspect 27: An artificial nipple includes a substantially solid nipple body and a plurality of fluid passageways. The nipple body has a base and a mouth extending longitudinally from the base. The nipple body has a proximal end face at the base and a distal end face disposed opposite the mouth. Each of the plurality of fluid passageways extends longitudinally from an inlet opening disposed in the proximal end face to an outlet opening disposed in the distal end face.

[0079] Aspect 28: An artificial nipple as described in Aspect 27, wherein the nipple body is solid from the proximal end surface to the distal end surface, except that it includes a fluid passageway.

[0080] Aspect 29: An artificial nipple according to aspect 27 or 28, wherein the nipple body has a completely solid volume other than the volume defined by each of the fluid passages.

[0081] Aspect 30: The artificial nipple according to any one of aspects 27 to 29, wherein the nipple body has an external flange.

[0082] Aspect 31: The artificial nipple of any of Aspects 27-30, wherein the external flange is a partially or fully annular flange extending laterally outward from the base.

[0083] Aspect 32: The artificial nipple of any of Aspects 27 to 31, wherein the plurality of fluid passageways includes at least two fluid passageways.

[0084] Aspect 33: The artificial nipple of any of Aspects 27 to 32, wherein the plurality of fluid passageways includes three fluid passageways.

[0085] Aspect 34: An artificial nipple according to any one of Aspects 27 to 33, wherein each fluid passage extends linearly in the longitudinal direction so that the lateral diameters of the inlet opening, the fluid passage, and the outlet opening are all the same.

[0086] Aspect 35: The artificial nipple of any of Aspects 27-34, wherein the lateral diameter of each fluid passageway is the same as each of the other fluid passageways.

[0087] Aspect 36: The artificial nipple of any of Aspects 27-34, wherein at least one of the fluid passageways has a different lateral diameter than at least one of the other fluid passageways.

[0088] Aspect 37: The artificial nipple of any of Aspects 27-33 and 35-36, wherein at least one of the fluid passageways is tapered between the inlet opening and the outlet opening.

[0089] Aspect 38: The artificial nipple according to any one of Aspects 27 to 37, wherein the artificial nipple comprises at least one tapered fluid passage and at least one straight fluid passage.

[0090] Aspect 39: The artificial nipple according to any one of Aspects 1 to 38, wherein the mouth portion is configured to be at least partially inserted into the oral cavity of a subject.

[0091] Aspect 40: The artificial nipple of any of aspects 1-39, wherein the base has a larger transverse diameter than the mouth.

[0092] Aspect 41: A baby bottle comprises a container and the artificial nipple of any of Aspects 27 to 40. The container has an internal cavity and a container opening in fluid communication with the internal cavity. The artificial nipple of any of Aspects 27 to 40 is secured to the container such that the inlet opening is axially aligned with the container opening and fluidly connects the internal cavity to the fluid passage of the network.

[0093] Aspect 42: The baby bottle of aspect 41, further comprising a collar for securing the artificial nipple to the container.

[0094] Aspect 43: A baby bottle according to aspect 41 or 42, wherein the collar includes internal threads configured to threadably engage with external threads on the exterior of the container to secure the collar to the container.

[0095] Aspect 44: A baby bottle according to any of aspects 41 to 43, wherein when the artificial nipple is fixed to the container, the external flange of the artificial nipple is positioned longitudinally between the internal flange of the collar and the rim of the container, and is held in such position by compressive force.

[0096] While aspects of the present disclosure have been shown and described in detail above with reference to exemplary embodiments, those skilled in the art will recognize that additional variations are possible. For example, the specific methods for using the devices described above are merely exemplary. Those skilled in the art can readily determine any number of tools, sequences of steps, or other means / options for placing the devices or their components in substantially similar positions as shown and described herein.

[0097] To maintain clarity in the figures, certain components among the overlapping components shown have not been specifically numbered, but one skilled in the art would recognize the element numbers to be associated with the unnumbered components based on the numbered components. No distinction between similar components is intended or implied solely by the presence or absence of element numbers in the figures.

[0098] Any of the described structures and components may be integrally formed as a single, unitary or monolithic part, or may be comprised of separate subcomponents, either of which may involve any suitable off-the-shelf or custom components and / or any suitable material or combination of materials. Any of the described structures and components may be disposable or reusable as needed for a particular use environment. Any component may be provided with user-recognizable markings to indicate the material, construction, at least one dimension, etc. associated with that component, potentially aiding a user in selecting one component from among many similar components for a particular use environment.

[0099] Although certain components described herein are shown as having particular geometric shapes, all structures of the present disclosure may have any suitable shape, size, configuration, relative relationship, cross-sectional area, or any other physical characteristic as needed for a particular application.

[0100] Any structure or feature described with reference to one aspect or configuration may also be provided in any other aspect or configuration, alone or in combination with other structures or features, as it would be impractical to describe each aspect and configuration described herein as having all of the described options with respect to all other aspects and configurations. It is understood that devices or methods incorporating any of these features fall within the scope of the present disclosure, as determined by the following claims and their equivalents.

[0101] Other aspects, objects, and advantages can be obtained from a consideration of the drawings, this disclosure, and the appended claims. All patents, patent applications, and publications cited herein are hereby incorporated by reference in their entirety.

[0102] The following examples are for illustrative purposes only and are not intended to limit the scope of the appended claims.

[0103] [Example 1] To test the hypothesis that solid soft tissue nipples affect infant feeding function throughout ontogeny, we conducted experiments using pigs, a validated animal model for infant feeding (German et al., Dysphagia. 2017;32:73-7). This experiment utilized an artificial nipple 100 identical or substantially similar to the artificial nipple 500 in FIG. 5. Animal models are essential tools for assessing infant feeding function because they allow for improved control of experimental settings and longitudinal study designs. Furthermore, animal models allow for the acquisition of data with much higher spatial and temporal resolution than human infants due to ethical considerations associated with radiation exposure during videofluoroscopic swallowing studies.

[0104] The results of this study are useful for clarifying the utility of tubular soft-tissue bottle nipples for infant feeding. Infants fed with tubular nipples demonstrated several correlates of breastfeeding, including increased pressure generation during feeding. Furthermore, tubular nipple feeding resulted in a decreased rate of aspiration, particularly when fed with a tubular nipple. This is particularly important in the context of challenging infants who are at risk for health consequences associated with aspiration, such as aspiration pneumonia. The use of tubular nipples has several other implications, including facilitating the ability of caregivers who may only be able to provide bottle-feeding to switch between bottle and breastfeeding, thereby providing bottle-fed infants with the physiological benefits of breastfeeding.

[0105] method Animal care and maintenance We obtained 48-hour-old suckling piglets (Yorkshire / Landrace) (Shoup Investments LTD, Wooster, OH, USA). The suckling piglets were housed in the NEOMED Comparative Medicine Unit and trained to feed on infant milk replacer (Solustart Pig Milk Replacement, Land o'Lakes, Arden Mills, MN, USA). All care and procedures for the piglets were approved by NEOMED IACUC protocol #19-03-222.

[0106] Nipples and experimental design Infants were divided into two groups: those fed with a standard cisternal nipple (hereafter referred to as "cisternal infants") and those fed with a tubular nipple (hereafter referred to as "tubular infants"). The size and shape of the nipples were determined based on measurements taken from multiple nursing mothers, ensuring that both nipples were identical in shape. A mold was then 3D printed and used to mold the nipples out of silicone. Based on the material properties of the nipples, the durometer rating of breast tissue was estimated as a scale of 00 to 10 (Briot et al. In vivo measurement of breast tissue stiffness using a light aspiration device. Clinical Biomechanics. 99, 105743 (2022); Ramiao et al. Biomechanical properties of breast tissue, a state-of-the-art review. Biomech Model Mechanobiol 15, 1307-1323 (2016)). Consistent results were achieved with a 00-20 silicone rubber (Smooth-on Ecoflex 00-20). To determine behavioral differences between infant groups, the amount of force required to compress the nipple by 50% was measured. This was done for nipples with different durometer ratings; the 20A silicone nipple was the most similar (Smooth-on Dragonskin 20a). The flow rates of both types of nipple were matched both experimentally and by Poiseuille's law. This ensured that the only difference between the nipple designs was whether they were tubular or trough-shaped. Because many mammalian species have multiple openings in their nipples, the final tubular nipple was molded with three separate tubes, and the total flow rate was equal between the nipples (Figure 17).

[0107] Pigs were reared on each reference teat for approximately 20 days (corresponding to approximately 8-month-old sucklings). During this period, total milk yield per feeding, as well as the time of feeding, were recorded and averaged for each day. Suckling weights were also recorded daily.

[0108] Data collection At approximately 20 days of age, pigs were recorded while feeding using a high-speed camera (XC1 M, XCitex, Cambridge, MA, USA) at 120 frames per second using high-speed biplane videofluorography (GE 9400C-Arm, 71–73 kV, 6.3–7.1 mA). Pigs were first fed on the rearing nipple and then on the other nipple to record feeding behavior upon first exposure to a different nipple. Approximately 20 swallows were collected per pig and condition. X-ray data were synchronized with intraoral pressure development using a 16-channel powerlab (16–35, AD Instruments, Colorado Springs, CO, USA) at 10 kHz.

[0109] Data Processing Standard procedures were used to identify suction timing from X-ray videos. A total of 1,165 suctions were identified (cisternal pigs feeding with cisternal nipples, N = 309; cisternal pigs feeding with tubular nipples, N = 278; tubular pigs feeding with cisternal nipples, N = 307; tubular pigs feeding with tubular nipples, N = 271). Suctions were identified as beginning on the frame where the tongue sealed anteriorly with the hard palate and ending on the frame before the next suction began. The instantaneous suction rate was calculated as 1 divided by the duration of the suction.

[0110] Swallowing was identified according to standard procedures as beginning at the time the bolus was deposited in the supraglottic space prior to passage through the epiglottis (Mayerl et al., Journal of Applied Physiology. 2019;126:1681-6; Mayerl et al., Journal of Applied Physiology. 2020;129:1383-92; Mayerl et al., Proc R Soc B. 2021;288:20210052). A total of 373 swallows were recorded (N = 96 in alveolar pigs fed with alveolar nipples, N = 95 in alveolar pigs fed with tubular nipples, N = 88 in tubular pigs fed with alveolar nipples, and N = 94 in tubular pigs fed with tubular nipples). Swallowing rate was calculated by dividing 1 by the time to the next aspiration, according to standard procedures (Mayerl et al., Proc R Soc B. 2021;288:20210052). Aspiration per swallow was calculated by recording the number of aspirations contributing to each swallow. Bolus size was calculated using ImageJ as the surface area of ​​the bolus at the start of swallowing (units: mm). 2 The amount of milk taken per suction was calculated for a given swallow by dividing the bolus size by the number of suctions required to produce the bolus. The frequency of penetration and aspiration was determined using the Infant Mammalian Penetration Aspiration Scale (IMPAS), an equivalent scale to the Penetration Aspiration Scale designed for adults.

[0111] Intraoral pressures were filtered with a 60 Hz low-pass filter to remove baseline electronic noise, downsampled at 83 Hz (~120 Hz, matching the frame rate), and exported from PowerLab. Pressure development data, along with data on the timing of suction and swallowing, were loaded into a custom Matlab routine, which calculated the amount of pressure (in mmHg) developed for each suction and swallow.

[0112] statistical analysis All statistical analyses were performed in R (v4.3.0). Linear mixed-effects models (Bates, D., Machler, M., Bolker, B., & Walker, S. (2015). Fitting Linear Mixed-Effects Models Using lme4. Journal of Statistical Software, 67(1), 1-48) were used to examine differences in variables of interest, with the nipple on which the individual was fed, the nipple the infant was feeding from, and their interaction as fixed effects, and individual infants as random effects. Variables of interest included sucking rate, swallowing rate, pressure generated per suck, bolus volume, feeding efficiency, and sucking per swallow. P values ​​for main effects were calculated using the Anova() function on the R models. If interactions between effects were significant, planned contrast analyses were performed, as well as Cohen's D (Cohen, J. (1992). A power primer. Psychological Bulletin, 112(1), 155-159).

[0113] To examine differences in swallow safety, logistic regression was performed to assess differences among all four groups. Swallowing without penetration or penetration with clearance was also combined as "safe," resulting in three levels (safe, penetration without clearance, and aspiration). Logistic regression analysis calculated odds ratios for group-dependent separation from safe swallowing, and p-values ​​were calculated using Wald-Chi-Squared Analyses (Mayerl et al., Journal of Applied Physiology. 2020; 129:1383-92).

[0114] result Ontogenetic behavior Although both groups were allowed to feed ad libitum, infants fed with tubular teats were found to be slightly larger than those fed with trough teats, although the difference was not significant by the end of insufficiency (approximately 20 days) (F = 2.6, p = 0.13; trough mean = 2.4 ± 0.4 kg, tubular mean = 2.8 ± 0.4 kg). Furthermore, assessment of feeding efficiency revealed that pigs fed more efficiently on the tubular teat within 15 days, a pattern that continued throughout insufficiency (day 20 means: trough mean = 2.3 ± 0.9 ml / s, tubular mean = 3.2 ± 0.5 ml / s; F = 12.6, p = 0.01).

[0115] Behavioral responses to nipple design Overall, there was little difference in sucking or swallowing rates depending on the teat the pigs were reared on or feeding from. Pigs reared on tubular teats had substantially no difference in sucking or swallowing rates when feeding on tubular or trough teats, and pigs feeding on tubular teats did not differ from trough pigs feeding on tubular teats in terms of sucking and swallowing rates (p>0.05, small Cohen's D, Table 1, Figure 18). [Table 1]

[0116] However, pigs reared with trough nipples and fed with trough nipples had a higher rate of aspirating than pigs reared with tubular nipples (t=5.9, p<0.001, D=0.67) or pigs reared with tubular nipples and fed with trough nipples (t=8.01, p<0.001, D=0.75).Also, trough pigs fed with trough nipples swallowed at a higher rate than tubular pigs fed with trough nipples (t=5.8, p<0.-1, D=0.8), but this was not statistically significantly higher than when fed with tubular nipples (t=3.7, p<0.001, D=0.45).

[0117] Physiological responses to nipple design In contrast to the lack of response in behavioral rates, substantial differences in physiology were observed depending on both the nipple on which the infants were reared and the nipple from which they were fed. This was particularly evident for pigs reared on bath nipples and fed on tubular nipples. These pigs had lower pressure per suck (t = -8.8, p < 0.001, D = 0.85), less efficient suckling (t = -6.0, p < 0.001, D = 1.1), and smaller food boli (t = -8.9, p < 0.001, D = 1.4) than pigs reared on tubular nipples and fed on tubular nipples (Figure 19, Tables 1 and 2). [Table 2]

[0118] Also, bath-reared pigs had fewer sucks per suck and less efficient feeding when fed on tubular teats compared to bath-reared teats, although the effect size was medium (Figure 19, Tables 1 and 2). Infants fed on tubular teats had lower pressure generation, lower feeding efficiency, and smaller food boluses when fed on tubular teats (Tables 1 and 2).

[0119] Swallowing safety influenced by nipple design Using pigs reared with and feeding on trough nipples as a baseline, we found that the odds of penetration and aspiration were influenced by the nipple from which the infant was feeding and, to a lesser extent, the nipple on which the infant was reared. Pigs reared with and feeding on tubular nipples had a 2.18 reduced log odds of penetration (p<0.001) and a 2.6 reduced log odds of aspiration (p<0.001) (Table 3). Pigs reared with and feeding on trough nipples, compared to those reared with tubular nipples, had a 1.01 reduced log odds of penetration (p<0.01) and a 0.69 reduced log odds of aspiration (p<0.05). For pigs fed with trough teats, there was no change in the log odds of intrusion when fed with tubular teats, but the log odds of aspiration was reduced by 0.68 with marginal statistical significance (p=0.06).

[0120] [Table 3]

[0121] [Example 2] To test the hypothesis that solid soft tissue nipples affect infant feeding function throughout ontogeny, we conducted experiments using pigs, a validated animal model for infant feeding (German et al., Dysphagia. 2017;32:73-7). This experiment utilized an artificial nipple 100 identical or substantially similar to the artificial nipple shown in FIG. 13. Animal models are essential tools for assessing infant feeding function because they allow for improved control of experimental settings and longitudinal study designs. Furthermore, animal models allow for the acquisition of data with much higher spatial and temporal resolution than human infants due to ethical considerations associated with radiation exposure during videofluoroscopic swallowing studies.

[0122] method Animal care and maintenance Twenty-four-hour-old suckling piglets (Yorkshire / Landrace) (Premier BioSource, CA, USA) were obtained. The suckling piglets were housed in the NAU Comparative Medicine Unit and trained to feed on infant milk replacer (Birthright, Ralco Show, Marshall, MN, USA). All care and procedures for the piglets were approved by NAU IACUC protocol #10-2022.

[0123] Nipples and experimental design Infants were divided into two groups: those fed with a standard cisternal nipple (hereafter referred to as "cisternal infants") and those fed with a tubular nipple (hereafter referred to as "tubular infants"). The size and shape of the nipples were determined based on measurements taken from multiple nursing mothers, ensuring that both nipples were identical in shape. A mold was then 3D printed and used to mold the nipples out of silicone. Based on the material properties of the nipples, a durometer rating of breast tissue was estimated (Briot et al. In vivo measurement of breast tissue stiffness using a light aspiration device. Clinical Biomechanics. 99, 105743 (2022); Ramiao et al. Biomechanical properties of breast tissue, a state-of-the-art review. Biomech Model Mechanobiol 15, 1307-1323 (2016)). Consistent results were achieved with a 00-10 silicone rubber (Smooth-on Ecoflex 00-10). To determine behavioral differences between infant groups, the amount of force required to compress the nipple by 50% was measured. This was done for nipples with different durometer ratings; the 20A silicone nipple was the most similar (Smooth-on Dragonskin 20a). The flow rates of both types of nipple were matched both experimentally and by Poiseuille's law. This ensured that the only difference between the nipple designs was whether they were tubular or trough-shaped. Because many mammalian species have multiple openings in their nipples, the final tubular nipple was molded with three separate tubes, and the total flow rate was equal between the nipples.

[0124] Pigs were reared on each reference teat for approximately 28 days (corresponding to approximately 10-month-old sucklings). During this period, total milk yield per feeding, as well as the time of feeding, were recorded and averaged for each day. Milk yield was matched between groups in this study. Pup weights were also recorded daily.

[0125] Data collection At approximately 28 days of age, pigs were recorded while feeding using a high-speed videofluorography (GE 9400C-Arm, 71–73 kV, 6.3–7.1 mA) with a 100-frame / s high-speed camera (Redwood, IO Industries, Ontario, Canada). Pigs were first fed on the rearing nipple and then on the other nipple to record feeding behavior upon first exposure to a different nipple. Approximately 20 swallows were collected per pig and condition. X-ray data were synchronized with intraoral pressure development using a 16-channel powerlab (16–35, AD Instruments, Colorado Springs, CO, USA) at 10 kHz.

[0126] Data Processing Suction timing was identified from the X-ray videos using standard procedures. A total of 833 suctions were identified (N = 203 for alveolar pigs feeding with alveolar nipples, N = 235 for alveolar pigs feeding with tubular nipples, N = 203 for tubular pigs feeding with alveolar nipples, and N = 192 for tubular pigs feeding with tubular nipples). Suctions were identified as beginning at the frame where the tongue sealed anteriorly with the hard palate and ending at the frame before the next suction began. The instantaneous suction rate was calculated by dividing 1 by the duration of the suction. Data processing of the ontogenetic data presented in Figure 21 was achieved by identifying suctions as the time between peaks in the pressure wave and separating the waves to obtain data for each suction. For tubular pigs, 663, 458, and 482 aspirations were identified on days 4, 11, and 19, respectively, and for bathtub pigs, 356, 499, and 451 aspirations were identified on days 4, 11, and 19, respectively. Data for day 28 are the same as above.

[0127] Swallowing was identified according to standard procedures as beginning at the time the bolus was deposited in the supraglottic space prior to passage through the epiglottis (Mayerl et al., Journal of Applied Physiology. 2019;126:1681-6; Mayerl et al., Journal of Applied Physiology. 2020;129:1383-92; Mayerl et al., Proc R Soc B. 2021;288:20210052). A total of 343 swallows were recorded (N = 80 for alveolar pigs fed with alveolar nipples, N = 89 for alveolar pigs fed with tubular nipples, N = 87 for tubular pigs fed with alveolar nipples, and N = 986 for tubular pigs fed with tubular nipples). Swallowing rate was calculated by dividing 1 by the time to the next aspiration, according to standard procedures (Mayerl et al., Proc R Soc B. 2021;288:20210052). Aspiration per swallow was calculated by recording the number of aspirations contributing to each swallow. Bolus size was calculated using ImageJ as the surface area of ​​the bolus at the start of swallowing (units: mm). 2 The amount of milk taken per suction was calculated for a given swallow by dividing the bolus size by the number of suctions required to produce the bolus.

[0128] Intraoral pressures were filtered with a 60 Hz low-pass filter to remove baseline electronic noise, integrated to match a video frame rate of 100 fps, and exported from Power Lab. Pressure development data, along with data on the timing of suction and swallowing, were loaded into a custom Matlab routine, which calculated the amount of pressure (in mmHg) developed with each suction and swallow.

[0129] statistical analysis All statistical analyses were performed in R (v4.3.0). Linear mixed-effects models (Bates, D., Machler, M., Bolker, B., & Walker, S. (2015). Fitting Linear Mixed-Effects Models Using lme4. Journal of Statistical Software, 67(1), 1-48) were used to examine differences in variables of interest, with the nipple on which the individual was fed, the nipple the infant was feeding from, and their interaction as fixed effects, and individual infants as random effects. Variables of interest included pressure generated per suck, bolus volume, feeding efficiency, and tongue movements. P values ​​for main effects were calculated using the Anova() function on the R models. If interactions between effects were significant, planned contrast analyses were performed, as well as Cohen's D (Cohen, J. (1992). A power primer. Psychological Bulletin, 112(1), 155-159).

[0130] result Pigs raised with the tubular teats of the present disclosure learn to latch on quickly As shown in FIG. 20, pigs reared with bath nipples (blue) reached full attachment slower than pigs reared with tubular nipples of the present disclosure (green).

[0131] Pigs raised with the disclosed bath nipples develop less sucking throughout their ontogeny. As shown in Figure 21, pigs reared with bath nipples (blue) had less oral sucking throughout ontogeny than pigs reared with tubular nipples of the present disclosure (green) (p<0.0001, Cohen's d>1). Pigs reared with tubular nipples had greater oral sucking earlier in ontogeny than pigs reared with bath nipples. At 28 days of age, both groups of pigs had similar oral sucking.

[0132] Pigs raised with trough nipples consume milk more quickly As shown in Figure 22, pigs raised with bath-type nipples (blue) consumed milk more quickly throughout ontogeny than pigs raised with the tubular nipples of the present disclosure (green) (p<0.005). Additionally, pigs raised with bath-type nipples (blue) increased their feeding rate more quickly throughout ontogeny than pigs raised with tubular nipples (green) (p<0.0001). Previous studies have shown that faster milk intake is associated with a higher incidence of aspiration. These data reflect data regarding the differences between bottle-feeding and breastfeeding, as breastfeeding rates are reduced compared to traditional bottle-feeding.

[0133] Pigs reared with trough nipples are more dependent on milk secretion As shown in Figure 23, at 28 days of age, pigs fed with bath-shaped teats (blue) compressed their teats (i.e., moved their tongues and jaws up and down) more than pigs fed with tubular teats of the present disclosure (green) (p<0.001, Cohen's d>1). Also, pigs reared with bath-shaped teats (left) compressed their teats more than pigs reared with tubular teats (right) (p<0.001, Cohen's d>0.8). Nipple compression causes milk to be secreted. This explains the higher feeding rates of pigs reared with bath-shaped teats compared to pigs reared with tubular teats.

[0134] Pigs develop similar oral suction on both types of teats As shown in Figure 24, at 28 days of age, all pigs developed oral sucking (p>0.05) regardless of the type of teat they were raised on or fed from.

[0135] Pigs ate faster on trough teats (especially when reared on trough teats) As shown in Figure 25, at 28 days of age, pigs fed with bath-shaped teats (blue) consumed milk faster than pigs fed with the disclosed tubular teats (green) (p<0.0001, Cohen's d>0.9). This difference was particularly pronounced for pigs reared with bath-shaped teats (the effect size was twice as large compared to pigs reared with tubular teats).

[0136] Taken together, the results in Figures 21-25 indicate that bath-fed infants use a combination of suction and nipple compression (resulting in secretion) when feeding, while tubular-fed infants only use suction to feed, reflecting the difference between breastfeeding (a suction-based mechanism) and traditional bottle-feeding (which can occur with a combination of suction and secretion).

Claims

1. a nipple body having a base and a mouth extending longitudinally from the base, the nipple body having a proximal end face at the base and a distal end face disposed opposite the proximal end face at the mouth; a network comprising a plurality of fluid passageways extending between a plurality of inlet openings disposed at or adjacent to the proximal end face and a single outlet opening disposed at or adjacent to the distal end face; An artificial nipple.

2. 10. The artificial nipple of claim 1, wherein the network comprises multiple layers along the longitudinal length of the artificial nipple, each layer comprising at least one fluid passage in direct fluid communication with at least two fluid passages in another layer.

3. 3. The artificial nipple of claim 2, wherein the number of fluid passages between two adjacent layers varies by a factor of two or three.

4. The layer a first layer having eight fluid passages, each fluid passage of the first layer having a first end in fluid communication with an associated one of the inlet openings and a second end; a second layer having four fluid passages, each fluid passage of the second layer having a first end in fluid communication with the second ends of two adjacent fluid passages of the first layer and a second end; a third layer having two fluid passages, each fluid passage of the third layer having a first end in fluid communication with the second ends of two adjacent fluid passages of the second layer and a second end; a fourth layer having a fluid passageway, the fourth layer fluid passageway having a first end in fluid communication with the second end of the fluid passageway in the third layer and a second end in fluid communication with the single outlet opening; The artificial nipple of claim 2, comprising:

5. The layer a first layer having nine fluid passages, each fluid passage of the first layer having a first end in fluid communication with an associated one of the inlet openings and a second end; a second layer having three fluid passages, each fluid passage of the second layer having a first end in fluid communication with the second ends of three adjacent fluid passages of the first layer and a second end; a third layer having a fluid passageway, the fluid passageway of the third layer having a first end in fluid communication with the second end of the fluid passageway of the second layer and a second end in fluid communication with the single outlet opening; The artificial nipple of claim 2, comprising:

6. The artificial nipple of claim 1 , wherein the network is defined by a network structure formed separately from the nipple body and at least partially surrounded by the nipple body.

7. The artificial nipple of claim 6 , wherein the nipple body is overmolded onto the network structure.

8. 2. The artificial nipple of claim 1, wherein the network is formed by omitting a portion of the nipple body material within the nipple body, without any separate structure remaining inside and / or outside the nipple body during use.

9. The artificial nipple of claim 1 , wherein the nipple body is solid from the proximal end surface to the distal end surface except for the inclusion of the network.

10. The artificial nipple of claim 1 , wherein the nipple body has a completely solid volume other than the volume defined by the network.

11. a container having an internal cavity and a container opening in fluid communication with the internal cavity; 2. The artificial nipple of claim 1, wherein the inlet opening is secured to the container such that the inlet opening is axially aligned with the container opening and fluidly connects the internal cavity to the fluid passages of the network; A baby bottle.

12. 12. The baby bottle of claim 11, further comprising a collar for securing the artificial nipple to the container.

13. 13. The baby bottle of claim 12, wherein the collar includes internal threads configured to threadably mate with external threads on an exterior surface of the container to secure the collar to the container.

14. 14. The baby bottle of claim 13, wherein when the artificial nipple is secured to the container, the outer flange of the artificial nipple is longitudinally positioned between the inner flange of the collar and the rim of the container and is held in such position by a compressive force.

15. a substantially solid nipple body having a base and a mouth extending longitudinally from the base, the nipple body having a proximal end face at the base and a distal end face disposed opposite the proximal end face at the mouth; a plurality of fluid passages, each extending longitudinally from an inlet opening disposed at the proximal end surface to an outlet opening disposed at the distal end surface; An artificial nipple.

16. 16. The artificial nipple of claim 15, wherein the nipple body is solid from the proximal end face to the distal end face except where the fluid passage is included.

17. 16. The artificial nipple of claim 15, wherein the nipple body has a completely solid volume other than the volume defined by each of the fluid passages.

18. a container having an internal cavity and a container opening in fluid communication with the internal cavity; 16. The artificial nipple of claim 15, wherein the inlet opening is secured to the container such that the inlet opening is axially aligned with the container opening and fluidly connects the internal cavity to the fluid passageway; A baby bottle.

19. 20. The baby bottle of claim 18, further comprising a collar for securing the artificial nipple to the container.

20. 20. The baby bottle of claim 19, wherein when the artificial nipple is secured to the container, the outer flange of the artificial nipple is longitudinally positioned between the inner flange of the collar and the rim of the container and is held in such position by a compressive force.

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