CN116669678A - Sucking device for infants - Google Patents

Abstract

The human nipple has both nutritive and non-nutritive sucking functions, the only difference being the delivery of nutrient solution in the first instance. The present application combines these two suction devices. The nipple device comprises a first stiffening element arranged at the outer surface of the nipple portion and surrounding an inner elastomeric core. A second reinforcing element, such as a mesh reinforcement, may be added to improve seizure resistance without compromising stretchability or compressibility. The nipple device is bite resistant to prevent bite damage and stretch failure in infants; and is compressible so that the force exerted by the infant's tongue will be transmitted through the solid nipple core (in the case of an artificial feeding nipple) to compress and close the central tube to facilitate swallowing without causing vomiting, or (in the case of a pacifier) to reshape the nipple portion so that it conforms to the shape of the infant's mouth.

Description

Sucking device for infants

Cross Reference to Related Applications

The present application claims priority from U.S. patent application Ser. No. 17/509,192, filed on 25.10.2021, which claims priority from U.S. provisional application Ser. No. 63/107,403, filed on 29.10.2020, the entire contents of which are incorporated herein by reference.

Technical Field

The present invention relates generally to devices for infant sucking (including nutritional applications and non-nutritional applications), and more particularly to artificial or pacifiers designed to mimic the characteristics of natural teats and the role of such natural teats in the infant's mouth, whether for feeding or sedation.

Background

Newborns and infants benefit much from breast feeding, which is well documented in the scientific literature. Typically, the benefit of breast feeding is due to the unique chemical composition of breast milk. These benefits include providing protection against allergies, many diseases caused by bacteria and viruses (e.g., gastric viruses), respiratory diseases, ear infections, meningitis, etc. (see inPediatrics(1980, volume 65, pages 1121-1124) was written as "Breast-feeding reduces incidence of hospital admissions for infection in infants" by Fallot ME, boyd JL, oski FA. Breast feeding also prevents sudden infant death syndrome, improves mental performance, reduces malocclusions, and counteracts obesity.

It is also beneficial for the mother, as breast feeding accumulates for 24 months and is believed to reduce the risk of breast cancer and osteoporosis by half.

Furthermore, there is increasing evidence that the manner of delivery is also important. During lactation, infants perform a complex sequence of coordinated suction and mechanical tongue movements, known as a "suck-swallow-breathe" rhythm. In this sequence, the nipple portion of the natural breast functions in a very specific manner. (see inUltrasound in Medicine&Biology(in 2010,volume 36, line 11, pages 1797-1807) authors as McClellan, HL, sakaldis, VS, hepworth, AR, hartmann, PE and Geddes, DT, "Validation of Teat Diameter and Tongue Movement Measurements with B-Mode Ultrasound During Breastfeeding").

The steps of sucking-swallowing-breathing rhythm are summarized as follows:

1. initially, the tongue presses the nipple against the top of the mouth (hard palate) and squeezes shut the internal ducts, cutting off milk flow. This position is referred to as a "fully up" position. The extracted milk is then swallowed.

2. After swallowing, the tongue begins to descend from a fully upward position, loosening the papillary canal. This action initiates a "sucking" phase in which increased suction in the infant's mouth draws milk from the nipple through the nipple's canal into the infant's mouth. When enough milk has been expressed, the infant stops the tongue from moving downwards.

3. Eventually, the tongue begins to rise back until it is again in the fully upward position, pressing the nipple against the top of the mouth (hard palate), squeezing shut the canal and shutting off unwanted milk flow that may cause vomiting. At this point the infant swallows again, evacuating most of the milk in the mouth.

This milk sucking rhythm is very laborious for infants. This exertion, and the fact that it occurs with very specific strength, orientation, sequence, etc. in breast feeding, brings the benefit of natural design.

The mechanical action of breast feeding is very different from feeding with a bottle that uses an artificial nipple. Breast feeding is a task. Intense muscle action may strengthen the chin muscles. These muscles pull on their attachments, causing the bones of the chin, hard palate and skull to develop in the form and proportion of the applied force; this results in beneficial remodeling of craniofacial bones and teeth. (see inJ Am Orthodontic Soc.(3/4, 28-32 pages 2012) authors Kevin Boyd "Darwinian Dentistry"). This is a natural design. For example, repeated squeezing of the nipple against the top of the mouth (which is soft for infants) can cause it to widen into a low U-shape. Tool withThe palate, having this shape, does not invade the sinuses and allows the development of properly aligned teeth. (see in J Human Lactation(1998, volume 14, phase 2, pages 93-98) authors were Palmer, b. The Influence of Breastfeeding on the Development of the Oral Cavity: ACommentary). Furthermore, studies have shown that infants feel tired after being full and stop eating due to exertion. This self-regulation avoids overfeeding, thereby reducing weight gain and reducing the incidence of obesity. (see inArch Pediatr Adolesc Med.(volume 166, phase 5, pages 431-436 in 2012) authors "Risk of patent-feeding for Rapid Weight Gain During the First Year of Life" by Ruowei Li et al.

The traditional feeding bottle nipple has no such benefits; in fact, they cause a number of new problems. These adverse effects of conventional feeding bottle nipples can be permanent, causing permanent damage. Traditional pacifiers differ greatly from the mother's nipple in terms of characteristics and muscle action required. These differences require infants to learn a different rate of milk intake than the natural rate. The beneficial muscle activity of natural lactation is lost, resulting in malocclusions and paranasal sinus dysplasia. (see Palmer (1998)). In addition, conventional baby bottle nipples are less labor intensive for the baby because they have an open orifice that can provide easy and adequate flow. It has been found that infants and young children tend to empty the bottle regardless of the amount of liquid, and regardless of whether it contains breast milk or formula. Traditional bottle nipples are associated with lack of self-regulation, overfeeding and excessive weight gain, which can lead to childhood obesity. (see in Int’l J.Obesity(London) (7.2014, volume 38, 7, pages 887-905) authors Peter T.Katzmarzyk et al, "An Evolving Scientific Basis for the Prevention and Treatment of Pediatric Obesity").

Clearly, there is a significant unmet need and significant commercial value for nutritive and non-nutritive sucking devices that have more human nipple-like characteristics and support muscle action more like natural breast feeding and sucking.

The human nipple has both nutritional and non-nutritional sucking functions. The characteristics or effect of the nipple will not change when alternating between these two functions. For this reason, the document filed by the present application combines two infant sucking devices, each replicating the characteristics and muscular action of a human nipple, the only difference being that, like a human nipple, one delivers the nutrient solution and the other does not.

Natural non-nutritive sucking (for sedation at the breast).Non-nutritive sucking (NNS) is a natural continuation of natural nutritive sucking, in which an infant sucks on the breast without expressing milk. Without a breast, an infant would typically suck on his thumb or fingers or an artificial nipple commonly known as a pacifier. Studies have shown that: non-nutritive sucking on something other than a natural nipple can lead to a number of negative consequences: breast feeding time is shortened, malocclusions are increased, and craniofacial dysplasia is observed. (see, e.g., in Medical Hypotheses(month 3 of 2013, volume 80, phase 3, pages 315-320) authors were "Understanding the relationships between breastfeeding, malocclusion, ADHD, sleep-disordered breathing, and traumatic dental injuries" by o.sambuccuoglu. Other reports show that high hardness pacifiers tend to be rejected by infants and can affect feeding results. (see inJ.Neonat.Nurs.(2008,2007.12.013) authors were Zimmerman, e., steven m.barlow, "Pacifier stiffness alters the dynamics of the suck central pattern generator").

The shortcomings of conventional bottle nipples and pacifiers in terms of nutritive and non-nutritive sucking stem from their design, which is caused by their materials of construction.

The design challenges of artificial nipples and pacifiers are that all infants eventually grow teeth, so the nipple and pacifier must be resistant to seizure and be able to prevent the risk of choking. The traditional nipple and pacifier are made of high-tearing-strength materials, generally silica gel with Shore A hardness of 50-70, and have good seizure resistance. Unfortunately, this material is very hard, almost as hard as an automobile tire. The stretching of a nipple or pacifier made of such a high hardness material is less than 1/10 of the natural nipple. To make the nipple or pacifier flexible, the designer makes them hollow. Traditional baby bottle nipples and pacifiers are quite different from natural nipples, both in nature and in function.

Furthermore, conventional baby bottle feeding nipples are hollow, rather than solid, so they cannot shut off fluid flow as natural nipples when squeezed by the baby's tongue. Also, conventional pacifiers are hollow and, depending on the design, they either collapse too easily or do not collapse at all. Such conventional pacifiers are not as strong as human nipples, and typically collapse upon compression. They cannot remodel their volume to conform to the contours of the infant's mouth, leading to the negative consequences described above.

Ideally, both the artificial feeding nipple and the pacifier should mimic the characteristics of a human nipple and support the muscular action of nutritive and/or non-nutritive sucking. They should have the following characteristics:

strong and has sufficient seizure resistance to prevent seizure damage and stretch failure in infants, thereby avoiding chipping and introducing choking hazards.

Solid and compressible, so that the force applied by the infant's tongue to the outer surface of the nipple will be transmitted through the solid nipple core (in the case of an artificial feeding nipple) to compress and close the central tube to facilitate swallowing without causing vomiting, or (in the case of a pacifier device) to reshape the nipple portion so that it conforms to the shape of the infant's mouth.

Softness, mimics a human nipple.

Is stretchable so that the infant can lengthen it to be properly positioned in the rear of the mouth.

Fig. 1A and 1B illustrate a conventional artificial feeding nipple known in the art. More specifically, this prior art design employs the teachings of U.S. patent No. 8,448,796 to Silver, which is a highly relevant part of the prior art that claims a nipple with radial compression closure and axial reinforcement.

In general, silver claims a solid nipple capable of cutting off fluid flow by radial compression and having "cylindrical reinforcing elements embedded in the solid nipple portion in a close but spaced-apart configuration relative to the one or more ducts, and the reinforcing elements having a greater tear resistance than the solid nipple portion. However, it has been determined that positioning the stiffening element in this manner does not allow the nipple to sufficiently mimic the natural sucking action of an infant. As will be shown, a stiffening element positioned "near … … tubing", such as that shown in fig. 1A and 1B, would unduly reduce the radial compressibility required for compression shut-off.

Referring to fig. 1A, and to fig. 18 of U.S. patent No. 8,448,796 to Silver, the prior art design includes a nipple 10 having a reinforcing element 12, shown as tubular in shape, positioned adjacent a central tube 14.Silver discloses other non-tubular reinforcing elements, all of which are located close to the central tube. It is expected that these other geometries will exhibit a high compression-shut-off resistance similar to the tubular samples tested. The base 16 and reinforcing member 12 are a tear resistant, high durometer material such as Shore A50-A70 silicone. The outer nipple portion 18 and the innermost material 20 (if present) are soft, low tear resistance, low durometer materials, such as shore A5 silicone.

In fig. 1A, the load path begins with a ninety newtons (about 20 pounds) load 22 for regulatory tests EN14350-1,6.3 (discussed in more detail below) pulling down on a bottle 24 using nipple 10. This force is transferred through the threads 26 that connect the bottle 24 to the attachment collar 28, which clamps (at a clamping force shown at 30) the nipple attachment flange 32 of the nipple 10 to the top of the bottle 24. The force is then transferred through the clamping area to the nipple flange 32, up the dome of the base 16 to the miter joint 34, where the high durometer base 16 adheres to the low durometer outer nipple portion 18. The miter joint 34 is in a sheared condition because the downward pulling force of the dome-shaped base 16 resists the upward pulling force of the outer nipple portion 18. The force is conducted through the outer nipple portion 18, through the bond line 36 (where the outer nipple portion 18 is bonded to the reinforcing element 12), then into the reinforcing element 12 and up the reinforcing element, back through the proximal end of the bond line 36, outwardly through the proximal end of the outer nipple portion 18, and then finally outwardly to the upper surface of the nipple portion where the grip applies an upward force 38. Under load, the outer nipple portion 18 will carry some load, but due to its low modulus of elasticity, it will carry a load that is much smaller than the stiffening element 12, which has a higher modulus of elasticity.

As shown with reference to fig. 1B, the radially compressive force 40 applied to the outer surface is transferred to the soft outer nipple portion 18, to the hard tubular reinforcing element 12, to the soft inner nipple portion 20 (if any), and finally to the central axial tube (14 becomes 14' upon compression). One major disadvantage of the Silver design is the regulatory requirement that the stiff tubular reinforcing element 12 be positioned "close to … … pipe". This results in a pipe wall thickness because it is required to carry axial loads and "close to … … pipe" so it resists compression of the pipe it tightly surrounds. Therefore, according to the design of Silver, a higher compression force is required to close the pipe.

The present invention addresses the limitations of conventional feeding teat designs (such as Silver) to optimise the sucking action and compression closure during use, whilst maintaining sufficient axial strength.

As mentioned above, conventional pacifiers are typically constructed of a high tear strength material, typically silica gel having a shore a hardness of between 50 and 70, with good seizure resistance. Unfortunately, such materials are very hard, stretch little or no. The harder they are, the more difficult it is to remodel into the geometry of the infant's mouth. Studies have shown that: non-nutritive sucking of things other than natural teats, especially on harder non-compliant pacifiers, can lead to a number of negative consequences: reduced breast feeding time, altered feeding cycle, increased malocclusion, and craniofacial dysplasia. (see Sabuncuoglu (2013); zimmerman & Barlow (2008)).

Fig. 2 shows a cross section of a typical commercial pacifier 100 comprising a tubular nipple portion 102, a dome shaped base 104 and a radially extending base flange 106. The pacifier 100 is entirely made of silicone having a hardness of approximately shore a50 to a 70. To provide flexibility to pacifier 100, nipple portion 102 and dome-shaped base 104 are both hollow. In other designs, the dome-shaped base 104 or base flange 106 attached to the nipple portion 102 may have a handle or guard constructed of a rigid plastic. As shown in fig. 2, nipple portion 102 has a nominally cylindrical shape. In other commercial pacifier designs, the nipple portion 102 may have a positive deformity.

Clearly, there is an important unmet need for a non-nutritive sucking device that has more human nipple-like characteristics and supports muscle action more like natural non-nutritive sucking. The present application commit addresses this unmet need.

It is relatively easy to design and produce a stretchable, soft, solid and compressible artificial nipple or pacifier. It is much more difficult to design a nipple that has these characteristics and is strong and resistant to bite damage and stretch failure. Such a soft, compressible nipple or pacifier which replicates the characteristics of a human nipple and possibly replicates the natural sucking action of an infant and is safe would be of considerable commercial value. The fact that such nipples or pacifiers have not been commercialized clearly shows that the design problem has not been solved by those skilled in the art. The document filed by the present application aims to correct this defect, as described below.

Thus, in general, there is a need for an artificial nipple that is bite safe, that is stretchable, soft, solid, and compressible, and that also prevents bite damage and stretch failure. The present invention aims to solve the problems associated with conventional artificial nipple designs, to remedy the drawbacks of the prior art, and to provide a method to circumvent the drawbacks associated with such prior art designs.

Disclosure of Invention

The present invention provides an infant sucking device, such as an artificial bite-safe nipple or nipple designed for use with an infant feeding bottle for nutritional feeding, and a pacifier device for use as a non-nutritional pacifier, each having sufficient axial strength to pass tests intended to simulate severe use and abuse, bite damage and overstretching of an infant, but retaining sufficient "stretchability" and radial compliance to be able to be compressively closed and/or reshaped by an infant to conform to the shape of the infant's mouth during sucking action.

In a first aspect of the invention, a device for nutritional sucking of an infant that resists bite but maintains longitudinal and lateral deformability includes an axially firm artificial feeding nipple with a compressed closure. In a preferred embodiment, the suction device comprises a solid nipple portion having a proximal end, a distal end and a generally cylindrical outer surface, although other shapes are possible. At least a portion of the nipple portion includes a first stiffening element extending longitudinally between a distal end of the nipple portion and a proximal end of the nipple portion and extending axially inward from a cylindrical outer surface of the nipple portion. The nipple portion further includes a core portion extending at least partially between the proximal and distal ends of the nipple portion and axially surrounded by the first reinforcing element and defining at least one conduit extending generally longitudinally from the distal end of the nipple portion to the proximal end of the nipple portion. The device further includes a base attached at the distal end of the nipple portion and having an open interior volume adjacent the distal end of the at least one tube.

According to an embodiment of the present invention, the first reinforcing element is made of an elastic material having a hardness of about shore A5 to about shore a70 and also having characteristics and cross-sectional area sufficient to impart seizure resistance and axial strength to expected seizure failure and excessive elongation by an infant user without compromising longitudinal and lateral deformability. Further, the inner core portion includes an elastomer having a hardness of about shore A1 to about shore a 20. The resulting composite nipple portion is sufficiently radially deformable to permit transmission of a compressive force of 8PSI or less applied laterally by the infant's tongue through the nipple portion, resulting in compressive collapse of at least one conduit, thereby stopping fluid flow.

In another aspect of the invention, a device for nutritional and non-nutritional infant sucking that resists bite but maintains longitudinal and lateral deformability includes a pacifier device capable of changing shape under the influence of infant sucking such that the device conforms to the shape of an infant's mouth during sucking action. In a preferred embodiment, the suction device comprises a solid nipple portion having a proximal end, a distal end and a generally cylindrical outer surface. At least a portion of the nipple portion includes a first stiffening element extending longitudinally between a distal end of the nipple portion and a proximal end of the nipple portion and extending axially inward from a cylindrical outer surface of the nipple portion. The nipple portion further includes a core portion extending at least partially between the proximal and distal ends of the nipple portion and axially surrounded by the first stiffening element. The device further includes a base attached at the distal end of the nipple portion.

In another aspect of the invention, the second stiffening element is arranged within the teat portion, preferably extending longitudinally between the distal end of the teat portion and the proximal end of the teat portion and radially within at least a portion of the first stiffening element. For example, the second reinforcing element may be sandwiched between the first reinforcing element and the core portion. In alternative embodiments, the second reinforcing element may be embedded within the first reinforcing element, such as in the form of a fiber mesh tube composed of fibers extending between the proximal end of the nipple portion and the distal end of the nipple portion to provide seizure resistance to the nipple portion without applying tension or compression to the nipple portion, or molded into the nipple portion as one of a solid tubular or mesh pattern as a moldable nylon or silicone material.

In aspects of the invention, the reinforcing element has a tear strength greater than or equal to the inner core portion of the nipple portion.

In another aspect of the invention, a bite-safe artificial nipple, such as a nipple, is used in an improved feeding system. Such systems include a collection container, typically a bottle, having a tubular top opening with a smooth top lip; a collar screwed onto the collection container, the collar having a top portion and a central aperture in the top portion, the top portion having a surface facing a collection container nominal plane parallel to an axis of the collar; and an artificial nipple having an unspecified design nipple portion, a base portion, and an attachment portion at a distal-most end of the artificial nipple, the attachment portion having a flat bottom cylindrical shape with flat distal and proximal surfaces and having a hole in the middle. In use, all parts protrude through the central aperture of the collar except for the washer-shaped proximal end of the nipple base, wherein in operation the nipple part is pulled through the central aperture in the collar and the collar is screwed onto the collection container. The collection container, collar and artificial nipple are configured such that when the collar is screwed on, the attachment portion of the nipple base is compressed between the distal bottom surface of the collar and the top rim of the collection container, sealing the nipple to the bottle. The V-shaped projection is also provided on the proximal bottom surface of the collar, positioned at a radial position centred on the rim of the bottle. A corresponding V-shaped groove is provided on the distal top surface of the attachment portion of the artificial nipple, said V-shaped groove being shaped and positioned such that the V-shaped protrusion of the collar fits into it.

As previously mentioned, the human nipple has both nutritive and non-nutritive sucking functions, and the characteristics or effect of the nipple do not change when alternating between the two functions. In this regard, the present invention has two main emphasis: (i) Artificial nipples or feeding nipples designed for nutritive sucking; and (ii) pacifier means designed for non-nutritive sucking. According to the invention, both devices have high strength to resist bite damage and elongation failure and a soft core to provide compression closure and conformability to the oral shape of an infant, respectively. Furthermore, each device replicates the characteristics and muscle action of a human nipple, the only difference being that one delivers the nutrient solution and the other does not.

These and other features of the present invention are described with reference to the drawings of a preferred embodiment of a bite-safe artificial nipple or nipple with a compressive shut-off function. The illustrated embodiments of the features of the present invention are intended to illustrate, but not limit the invention.

Drawings

Figure 1A shows a cross-sectional view of a feeding nipple representing a prior art arrangement.

Figure 1B shows the prior art feeding nipple of figure 1A in a compressed closed position.

Fig. 2 shows a cross-sectional view of a pacifier representing a prior art arrangement.

Figure 3A shows a cross-sectional view of a first embodiment of a nutritive infant sucking device according to the present invention.

Fig. 3B shows the compression closure of the infant sucking device of fig. 1A.

FIG. 4 is a table providing the results of the extension and compression closure test for a 0.5 inch diameter cylinder of silica gel.

Fig. 5 is a compression closure test result providing a comparison of a silica gel cylinder of 0.5 inch diameter with a reinforcing element according to the present invention as represented in fig. 3A on an outer surface or with a reinforcing element according to the prior art as represented in fig. 2.

Figure 6 shows a cross-sectional view of an alternative embodiment of a nutritional infant sucking device according to the present invention.

Figure 7 shows a cross-sectional view of a further alternative embodiment of a nutritive sucking device according to the present invention.

Fig. 8 shows the measured elongation (x=length ratio of elongated web tubing to relaxed web tubing) versus applied stress for a 0.5 inch cylindrical A5 silica gel sample with reinforcing elements comprising web tubing having an inner diameter of 0.375 inch and a different fiber pitch (pitch) in accordance with the present invention.

Fig. 9 shows the ratio of measured elongation (X, a measure of "stretchability") at 15PSI to the sample fiber pitch value divided by 0.71 inches, the ideal pitch being for dr=0.375 and the assumed value of X (=1.5).

Fig. 10 is a table showing the data plotted in fig. 9.

Figure 11 shows a partial cross-sectional view of an embodiment for attaching an infant sucking device, such as an artificial feeding nipple, to a collection container to address the problem of nipple pull-out during loading.

Figure 12 shows a cross-sectional view of a first embodiment of a non-nutritive infant sucking device according to the invention.

Figure 13 shows a cross-sectional view of an alternative embodiment of a non-nutritive infant sucking device according to the invention.

Fig. 14 shows pacifier elongation and stress data for the embodiments of the infant sucking device and commercial pacifier device shown in fig. 12 and 13.

Detailed Description

The following description of the drawings will convey details of the construction of a nutritive infant sucking device and a non-nutritive infant sucking device according to the present invention.

As used herein, the terms "proximal" and "distal" are used in their medical sense and in a direction relative to the user. Thus, the "proximal end" of the feeding nipple is the portion of the nipple closest to the infant, while the "distal end" of the feeding nipple is the portion of the nipple furthest from the infant.

Figure 3A illustrates a nutritional infant sucking device, such as a feeding nipple or nipple generally indicated at 210, including a nipple portion 212 and a base 214, according to an embodiment of the invention. As shown, nipple portion 212 includes a first stiffening element 216 and an inner core portion 218. The first stiffening element 216, which is assumed to be tubular, is positioned close to the nipple portion 212 or at the outer surface of said nipple portion. Generally, the first stiffening element 216 extends longitudinally between the distal end of the nipple portion 212 and the proximal end of the nipple portion 212 and further extends axially inwardly from the cylindrical outer surface of the nipple portion 212. As shown in the embodiment of fig. 6, the first stiffening element 216 may also extend to and around the tip 217 of the nipple portion 212.

First reinforcing member 216 preferably has a hardness of about shore A5 to about shore a70 and also has characteristics and cross-sectional area sufficient to impart seizure resistance and axial strength to intended bite damage and excessive elongation by an infant user without compromising longitudinal and lateral deformability.

Still referring to fig. 3A, the inner core portion 218 extends at least partially between the proximal and distal ends of the nipple portion 212 and is axially surrounded by the first stiffening element 216. As shown, the inner core portion 218 also defines at least one conduit 220 extending generally longitudinally from the distal end of the nipple portion 212 to the proximal end of the nipple portion 212. The inner core portion 218 is preferably made of a soft, low tear resistant, low durometer material. More preferably, inner core portion 218 includes an elastomer, such as silicone, having a hardness of about shore A1 to about shore a20, even more preferably about shore A5.

The resulting composite nipple portion 212 according to the invention has sufficient radial deformability to allow a compressive force of 8PSI or less applied laterally by the infant's tongue to be transmitted through the nipple portion 212, causing the at least one tube 220 to collapse in compression, thereby stopping fluid flow.

As described above, nipple 210 includes a substantially dome-like base 214 attached at the distal end of nipple portion 212 and including an open interior volume adjacent the distal end of at least one tube 220. The base 214 is preferably made of a tear resistant, high durometer material, such as silicone of shore a 50-a 70, such as the materials commonly used to construct conventional teats. The tear resistance and stiffness of first reinforcing element 216 is preferably the same as base 214 (e.g., shore a30 to shore a 70), or alternatively, the same as core portion 218 (e.g., shore A5 to shore a 20), or at least intermediate the tear resistance and stiffness of base 214 and softer core portion 218. Nipple portion 212 is attached to base 214 such that an axial load 222 applied from base 214 to the distal end of nipple portion 212 is transferred to first reinforcing element 216 through a miter joint 224 disposed between the dome of base 214 and the outboard distal surface of reinforcing element 212.

In use, nipple 210 is attached to a collection container, such as bottle 226, using attachment collar 228. The connection between the bottle 226 and collar 228 is typically accomplished by complementary threads 230 that grip an annular attachment flange 232 formed in the base 214 and including a top surface and an opposing bottom surface and defining a central opening. More specifically, the attachment collar 228 has an annular end defining a central opening and a first surface, and the nipple 210 is positioned such that the annular attachment flange portion 232 of the nipple 210 is positioned between the first surface of the attachment collar 228 and the smooth top lip of the bottle 226 when the attachment collar 228 is connected to the bottle 226 such that the distal end of the nipple 210 protrudes through the central opening of the annular end of the attachment collar 228, as shown in fig. 3A.

In embodiments of nipple 210 in which first reinforcing element 216 and nipple inner core portion 218 are constructed of the same material having the same tear resistance and hardness, first reinforcing element 216 and inner core portion 218 will be substantially separated by name only. In this case they will be the same single material with no geometric profile between them.

Nipple bite damage and tensile failure simulation test To evaluate the nipple improvement of the invention, specific tests are required to quantify the seizure resistance, elongation at break, stretchability, softness and compression closure. Some of these tests are specifically designed, others are current regulatory standards aimed at simulating infant use and abuse conditions and functionality. The use of specific test conditions is to allow the advantages of the invention to be quantified and to allow the invention to be compared to prior art devices, rather than advocate any specific test.

Nipple "use and abuse" mechanical testThe us nipple bite test defined in 16c.f.r. ≡ 1500.51 is relatively easy to pass and will not be considered further in connection with the present invention. In contrast, EN 14350-1,6.3 is a more stringent European and Canadian regulatory test. The test provides that, first, a 3 mm diameter chisel tip punch is driven under a load of 200N (about 45 lbs.) through the nipple portion of the artificial nipple. The perforation (denoted as reference numeral 250 in fig. 3A, but not forming part of the present invention) simulates the bite damage of an infant. Second, the (pierced) feeding teat and drinking fitment (referring to the nipple mounted on the bottle) is subjected to a load of 90N (about 20 lbs) applied between the bottle and the nipple tip. To pass the test, the nipple must not break or pull out from its attachment to the feeding bottle. This simulates additional bite damage and overstretching of the infant. In evaluating the present invention, EN 14350-1,6.3 will be used for evaluation purposes, but the nipple is loaded to 120N (30 lbs) rather than just performing a verification test according to the 90N (20 lbs) test standard.

EN 14350-1,6.3 is a very demanding test. In this embodiment, a separate design strategy will be described to address (a) nipple rupture and (b) nipple pull-out.

Artificial nipple ruptureTypically, stretchable, soft, solid and compressible artificial teats have a base portion that is attached to the bottle by a collar. Typically, the base portion is made of a strong, high durometer material with sufficiently high tear strength, such as Shore A50-A70 silicone rubber, and will hardly fail during the EN 14350-1,6.3 test because the base portion is not pierced. If a rupture occurs, the nipple portion always fails. The load path from the container through the base into the teat portion, then to each individual load bearing element within the teat portion, and finally to the teat tip is shown by the arrow in figure 3A.

In fig. 3A, for a load path pulling down the bottle 226 with a ninety newtons (about 20 pounds) load 222 for EN 14350-1,6.3, the force is transferred through threads 230 to the flat underside of attachment collar 228, which clamps (via the clamping force shown at 234) the flat nipple base flange 232 to the top rim of the bottle 226. The force is then transferred through the clamping area to the nipple base flange 232, up the dome of the base 214 to the miter joint 224 where the high durometer base 214 is bonded to the first reinforcing element 216. The miter joint 224 is in a sheared state because the downward pulling force of the dome of the base 214 resists the upward pulling force of the first stiffening element 216. The force is directed upwardly and outwardly along the first stiffening element 216 to the upper surface of the nipple portion 212 where the test grip applies an upward force 236. Bonded to the inner diameter of first stiffening element 216 is an inner core portion 218 of nipple portion 212, preferably comprising a soft, low tear resistant, low durometer material, such as a Shore A5 silicone. The puncture required for the EN 14350-1,6.3 test is illustrated at 250 passing transversely through the middle of the nipple portion, straight through the soft inner core portion 218 and the first stiffening element 216, but, as previously stated, this line is provided for illustration purposes and does not include any portion of the nipple device according to the invention.

Typically, nipple rupture occurs at the weakest link in this load-bearing chain. Since a nipple is typically made up of multiple parts, each having a specific geometry and location within the nipple, all of which are bonded together and to the base, the tensile, shear or other load that occurs when the nipple portion stretches under an applied load will depend on the characteristics of each part-e.g., modulus of elasticity, tear strength, tensile strength, shear strength, elongation at break, etc., and the interaction of these characteristics between each element of the nipple. For example, in the context of the nipple portion 212 of the present invention, the closer the modulus of elasticity of the first reinforcing element 216 and nipple core portion 218, the greater the load that nipple core portion 218 will carry.

Axial loading test resultsAs shown in the table of fig. 4, for a cylindrical silicone gel sample of 0.5 inch diameter having nominally the same soft nipple core material (e.g., shore A5 or shore A3) and having a failure load of greater than 20 pounds, the load bearing cross-section of the first reinforcing element 216 must be increased (representing the load bearing cross-section required by the bite damage and tensile failure simulation) when the first reinforcing element is constructed from a lower tear strength material. Shore a50 requires a cross-sectional area of 0.054 square inches, but shore a25 requires a larger area, i.e., 0.086 square inches, while shore a10 also requires a larger area, i.e., 0.126 square inches. Notably, even though each has a similar load carrying capacity, i.e., a failure load capacity of greater than 20 pounds, elongation at 15PSI load increases significantly with decreasing stiffening element stiffness: shore A50 is 7%; shore A25 is 31%; the Shore A10 was 74%. The samples with nipple portions constructed of only shore a10 elongated 54% at 15 PSI. Samples with nipple portions constructed of only shore A5 elongated 82% at 15 PSI.

The conclusion of the axial loading test is as follows:

the lower the tear strength of the reinforcing material, the proportionally greater the cross-sectional area of the material required to carry a particular axial load. For example, for a sample having a diameter of 0.5 inches and a shore A5 core, the stiffening element would bear 20 pounds of the desired wall thickness: 0.037 inches for shore a 50; 0.063 inches for shore a 25; 0.100 inches for shore a 10; and for samples consisting of only shore a10 or shore A5, the stiffening element must occupy the entire cross section of the tube wall.

The weakest link of the sample in the load path fails. Some samples failed by tearing the reinforcing material, others failed at the miter joint with the reinforcing material, and other nipples pulled from the bottle attachment.

Nipple compressionAs shown in fig. 3B, to be able to compress shut, nipple 210 must be solid so that lateral compressive forces (indicated by arrows 238) applied to the outer surface will be transferred through solid tubular stiffening element 216 to solid core portion 218, thereby compressing central axial tube (220 to become 220a upon compression) and thereby shutting off fluid flow so that an infant may swallow without flooding and possibly vomiting due to unwanted fluid flow.

Transverse compression loading test resultsAccording to the design of the invention, as shown in fig. 3A, the samples in the table of fig. 4 all have reinforcing elements at the outer surface of the nipple part. All samples were closed under similar compressive loads (generally between about 3 and 6 PSI).

Radial compression loading test results, reinforcement element positionThe table of fig. 5 provides data for a sample constructed of a first reinforcing element 216 made of a shore a50 elastomer and an inner core portion 218 made of a shore A5 elastomer, each having similar load bearing capabilities. One sample had the reinforcing element "on the outside" -i.e., on the outer nipple surface according to an embodiment of the invention, as shown in fig. 3A. Another sample positions the reinforcing element "inside" according to the prior art design shown in fig. 1A and designated in U.S. patent No. 8,448,796 to Silver.

The conclusion of the radial compression loading test is as follows:

the position of the stiffening element severely influences the required closing pressure.

The reinforcing elements on the outer surface are more compliant than the reinforcing elements which are nearly identical in cross-sectional area but immediately surround the central duct (as specified by Silver). As a result, the prior art elements actually have a wall thickness that is more than twice as thick as the reinforcing elements of the present invention. As with the prior art designs, the reduced compliance of the stiffening element immediately surrounding the central tube also increases the required closing pressure to 16PSI, 4 times the closing pressure of the stiffening element according to embodiments of the present invention.

A sucking infant may generate a maximum suction of about 200 mmhg, about 4 PSI. (see inEarly Hum Dev(month 7 of 2008; volume 84: pages 471-477), "tongue movement and intraoral vacuum in breast-fed infants" by DT Geddes et al. Assuming that the infant's tongue has a capacity for (upward) compression pressure no more than 50% of its recorded (downward) suction pressure, this indicates that the infant can only close the nipple requiring a closing pressure of less than about 6 PSI.

All samples with the stiffening element on the outer surface were closed between 3 and 6PSI, within the range of pressure that the infant can apply.

According to Silver, a sample with a thick-walled stiffening element on the inside, closely surrounding the central tube requires a closing pressure of 16PSI, far exceeding the estimated tongue pressure capability of the infant. Thus, infants are less likely to close a nipple constructed in accordance with the prior art nipple design of Silver.

Nipple improvementAn important advantage of the embodiment of the invention is better radial compressibility compared to Silver and other prior art teats. Comparing the designs of fig. 1B and 3B, it is apparent in view of the data presented in fig. 5 that for a reinforcing element of the same load bearing capacity, the thin walled (e.g., 0.037 inch) tubular reinforcing element near the outer surface of the nipple portion is radially more compliant, with the central tube compressed closed at 4 PSI. In contrast, a thick-walled (e.g., 0.088 inch) tubular reinforcing element that closely surrounds the center tube requires 4 times the compression pressure to close the tube, as specified by Silver. This is In addition, the compression pressure required exceeds the tongue force of the infant.

The lateral compressibility improvement of the present invention can be visualized as a design balance. With the tooling Cheng Shuyu, the axial strength of the nipple must be sufficient to withstand the failure load following bite failure. If a small cross-section high tear strength elastomer is used for the nipple, the stretchability of the nipple is lower (i.e., the percentage elongation at 15PSI is lower) than a nipple having the same failure load but a lower tear strength elastomer with a larger cross-section. On the other hand, compressibility and closure occur in the radial direction. For teats constructed of the same two materials and having substantially the same axial failure load, the location of the reinforcing element is critical to compressibility. When the stiffening element is a thin walled tube at or near the outer surface of the nipple, it will be very radially compressible as shown in fig. 3B and further represented in the closure data of the tables in fig. 4 and 5. In contrast, when the reinforcing material closely surrounds the central nipple tunnel, it must have a thick wall to provide the cross-sectional area required for axial strength. Such thick-walled tubes, which closely surround the central nipple tunnel, resist radial compression, requiring higher radial loads before the central tunnel closes. The latter case is shown in fig. 1B.

Further nipple improvementIn use, the single miter joint (shown as reference 224 in fig. 3A) is normally in a sheared state, caused by the nipple dome of the base 214 pulling down and the first stiffening element 216 pulling up. To reduce loading of the miter joint 224 and thereby reduce the chance of breakage at that location, an alternative embodiment of the present invention involves wrapping a high tear strength material of the nipple dome portion 214 around the distal end of the reinforcing element 216 to partially overlap and adhere to the distal inner surface of the first reinforcing element 216. The second miter joint 225, as shown in fig. 6, is designed to relieve the load of the original single miter joint 224.

As further shown in the alternative embodiment of fig. 6, the modification may also be caused by the proximal end of the first stiffening element 216 being at least partially wrapped around the nipple tip (such as represented by reference numeral 217). This design improves the resistance to seizure of the nipple tip because the material from which the first reinforcing element 216 is constructed has a higher tear strength and seizure resistance than the soft, low tear strength material from which the nipple inner core portion 218 and nipple tip are constructed as an extension of the core.

Another alternative embodiment eliminates the bond between the reinforcing member 216 and the core portion 218 by manufacturing the reinforcing member 216 and the core portion 218 from the same material (as represented by reference numeral 221 in fig. 3A). This is shown in the table of fig. 4 for solid shore a10 and solid shore A5 teats. In such embodiments, the first reinforcing element 216 and nipple core portion 217 will be separated only by name.

Another alternative embodiment is shown in fig. 7, which shows a feeding nipple generally designated 310. Similar components to those shown and described with reference to fig. 3A and 3b share similar reference numerals for ease of reference. As shown, nipple 310 includes nipple portion 312 attached to dome-shaped base 314. In addition to the first stiffening element 316 being constructed of a single homogeneous material in the manner described above and having the advantages described above, the nipple portion 312 also includes a second stiffening element generally designated 319. Preferably, the second reinforcing member 319 comprises a very strong, very high tear strength material. The second stiffening element 319 is generally disposed within the nipple portion 312, extends longitudinally between the distal end of the nipple portion 312 and the proximal end of the nipple portion 312, and is radially located within at least a portion of the first stiffening element 316. As shown in fig. 7, the second stiffening element 319 is positioned along the inner surface of the stiffening element 316, substantially sandwiched between the first stiffening element 316 and the inner core section 318, but other radial locations within the first stiffening element 316 are possible without departing from the principles and spirit of the invention. For example, the second reinforcing element 319 may be embedded within the first reinforcing element 316, such as in the form of a fiber mesh tube composed of fibers extending between the proximal end of the nipple portion 312 and the distal end of the nipple portion 312 to provide seizure resistance to the nipple 310 without applying tension or compression to the nipple portion 312, or molded into the nipple portion 312 as one of a solid tubular or mesh pattern as a moldable nylon or silicone material. Still further, the second reinforcing element 319 may also extend through the nipple tip 321 and/or even extend 323 into the base 314 for added strength.

As noted above, the second reinforcing element 319, which is very strong, very high tear strength, may be a fibrous web of strong polymeric fibers such as polyester or nylon, such as shown and described in U.S. patent No. 9,913,780, which is incorporated herein by reference. It may also be of a suitable in-mold molding material, solid tubular, mesh pattern or other form, made of a moldable material such as nylon, silicone or the like.

The very strong, very high tear strength material of the second reinforcing member 319 is designed to allow for easy radial compression while providing seizure resistance. Axial reinforcement is achieved by limiting excessive elongation that would otherwise lead to failure. Near failure conditions, the second reinforcing member 319 carries almost all axial loads, so it is extremely important to transfer the load from the base 314 to the second reinforcing member 319. In an alternative embodiment shown in fig. 7, to improve load transfer, the fibers comprising the second reinforcing element 319 preferably extend into the dome-shaped region of the base 314, such as at 323, where the fibers may be directly bonded to a high tear strength material (e.g., shore a50-a70 silicone rubber) constituting the dome-shaped region of the base 314.

In another embodiment of the application, when the fibres of the fibre mesh tube forming the reinforcing element in the nipple portion feeding the nipple are arranged in a very specific geometry and operate in a hypothetical elongation range (i.e. up to elongation X), they will not resist the elongation of the nipple portion. Outside this range, the fibers will increasingly exert tension on the nipple portion, reducing the desired soft, highly elastic properties of the nipple portion, but strengthening the nipple portion to prevent failure due to excessive elongation. Pitch P of this particular geometry _r Defined as P _r ＝πD _r √((1-1/X)/((X ² -1)) wherein P _r Is the axial length required for a complete fiber wrap when the fiber tube is relaxed rather than extended, D _r Is the relaxed diameter of the fiber mesh tube and the hypothetical elongation (X) is the length ratio of the elongated fiber mesh tube to the relaxed fiber mesh tube.

Fig. 8 depicts the measured elongation (X) versus applied stress for a 0.5 inch cylindrical shore A5 silica gel sample with an embedded fiber mesh tube having an inner diameter of 0.375 inch and different fiber pitches. In the relaxed diameter of the fiber web (D _r ) At =0.375 inch and elongation x=1.5, the ideal pitch calculated by the above equation is 0.71 inch. As the fiber pitch deviates from this ideal pitch, the "stretchability" of the sample at any given stress (e.g., 15 PSI) is reduced. This reduction is shown in fig. 9, where fig. 9 depicts the ratio of elongation at 15PSI (the value selected merely to compare the samples) ("measure of stretchability") to the sample fiber pitch value divided by 0.71 inches, the ideal pitch being for dr=0.375 and x=1.5. The data shown in the table of fig. 10 shows that the ideal pitch +/-15% covers the elongation (X) range from 1.7 to 1.35 (percent elongation decreases from 70% to 35%). For pitches 15% greater than ideal, the fibers begin to severely resist elongation. For this reason, an ideal pitch of +/-15% is claimed in the filing of the present application. This is the same as the +/-15% pitch range already granted in applicant's issued U.S. patent No. 9,913,780 entitled "bit-Safe Artificial Teat," which is incorporated herein by reference in its entirety.

Nipple attachment improvementAnother failure mode experienced by the feeding teat under heavy loading is caused by the pulling out of the flat teat base flange (reference numeral 232 in fig. 3A), wherein the flange 232 is clamped (clamping force is shown as 234 in fig. 3A) between the flat underside of the attachment collar 228 and the top rim of the bottle 226. The embodiment of the nipple according to the invention and as shown in fig. 11 solves this problem.

The feature found on some commercial bottle attachment collars is a "V-shaped" protrusion 400 that delineates a circular rim on the underside of the attachment collar 228 and is positioned radially over the center of the top rim of the bottle 226. The "V-shaped" protrusion 400 concentrates the clamping force 402, thereby increasing the resistance to pulling the nipple 210 out of the attachment collar 228 under high axial loading. However, testing has shown that this feature in prior art designs is not sufficient to prevent pullout. To further increase pull-out resistance, an improvement is provided in the present invention in the form of a "V-shaped" groove 404 on the top surface of nipple base flange 232 into which a "V-shaped" protrusion 400 on attachment collar 228 fits, significantly increasing pull-out resistance. Finally, knob 406 is added to attachment collar 228 in the position shown in fig. 11. The purpose of this knob 530 is to keep the nipple base flange 232 flat so that the forces exerted on the "V-shaped" protrusions 400 and the "V-shaped" grooves 404 remain in a radial direction. Without this knob 406, the nipple tends to rotate under load, as indicated by arrow 408, and this rotational movement may cause the nipple base flange 232 to rotate out from under the "V-shaped" projection 400, as indicated by arrow 410.

The invention also relates to non-nutritive sucking devices, such as pacifiers. Fig. 12 illustrates a non-nutritive pacifier device generally designated 510 and including a nipple portion 512 and a base 514 in accordance with an embodiment of the present invention. In a preferred embodiment, the suction device includes a solid nipple portion 512 having a proximal end, a distal end, and a generally cylindrical outer surface, although other shapes are possible without departing from the principles and spirit of the invention. As shown, nipple portion 512 includes a first reinforcing element 516 and an inner core portion 518. A first reinforcing element 516, shown as tubular, is positioned near or at the outer surface of the nipple portion 512. Generally, the first reinforcing element 516 extends longitudinally between the distal end of the nipple portion 512 and the proximal end of the nipple portion 512 and further extends axially inward from the cylindrical outer surface of the nipple portion 512. As shown, the first reinforcing element 516 may also extend to the tip of the nipple portion 512 and may extend into the base 514.

The nipple portion 512 further includes a core portion 518 extending at least partially between the proximal and distal ends of the nipple portion 512 and axially surrounded by the first reinforcing element 516. The device 510 further includes a base 514 attached at the distal end of the nipple portion 512. Distal sealing membrane 540 encapsulates inner core portion 518.

According to a preferred embodiment, pacifier device 510 is bite resistant, but maintains longitudinal and lateral deformability, and is capable of changing shape under the influence of the infant's sucking, such that the device conforms to the shape of the infant's mouth during the sucking action. By forming at least one conduit (not shown) through nipple portion 512 of device 510, the structure of pacifier device 510 may still function as an axially strong artificial nipple with a compressive closing function.

Pacifier supervision testThe requirements for pacifiers in section 1511 of federal regulations 16 in the united states:

the pacifier shield or shield at the base of the nipple remains under a load of 2 pounds for 10 seconds without pulling apart; and is also provided with

When holding the handle or guard and gradually pulling the nipple in all possible directions for 10 seconds below 10 pounds, the pacifier must not unravel.

Both test requirements are much lower than the nipple supervision test EN 14350-1,6.3 discussed above for the pacifier mechanical test in connection with the present application.

Pacifier embodimentsThe pacifier covered in the document filed by the present application is intended to replicate a human nipple in non-nutritive sucking. Thus, an ideal pacifier would have similar characteristics and effects to a human nipple in terms of non-nutritive sucking. Thus, many of the characteristics of the artificial nipple discussed in the nutritive sucking section above are applicable to the preferred embodiments of a non-nutritive pacifier device that does not transmit any fluid even when the pacifier is in use (as does non-nutritive sucking of a human nipple).

Thus, an ideal pacifier should mimic the characteristics of a human nipple. Specifically, it should be:

1. is strong and has sufficient seizure resistance to prevent bite damage and stretch failure in infants (even those with teeth), thereby avoiding the risk of splintering and choking.

2. Solid and deformable so that forces applied to the outer surface by the infant's tongue are transferred to and reshape the nipple portion to better conform to the shape of the infant's mouth.

3. Softness, mimics a human nipple.

4. Is stretchable so that the infant can lengthen it to be properly positioned in the rear of the mouth.

Fig. 12 shows a cross section of a pacifier device 510 according to an embodiment of the present invention and demonstrates characteristics of an ideal pacifier. As shown, pacifier 510 includes a first stiffening element 516, illustrated as tubular, but other shapes are possible without departing from the principles and spirit of the present invention, the first stiffening element being constructed of a material having a durometer between about shore A5 and shore a70 and being positioned proximate to or at an outer surface of nipple portion 512. The first reinforcing element 516 has characteristics and cross-sectional area sufficient to protect the device from bite damage and excessive elongation by an infant user while not compromising the desired longitudinal and lateral deformability.

The inner core portion 518, which extends primarily from the distal end to the proximal end of the nipple portion 512, is protected on its sides and wrapped around its proximal tip 517 by a first reinforcing element 516, and is encapsulated over the distal end of the nipple portion 512 with a layer of material 540 similar to that used to construct the first reinforcing element 516. The inner core portion 518 of nipple portion 512 is a deformable material, such as a soft, commercially available low durometer elastomer or gel, having a durometer between shore a20 to A5 on the order of shore 00. Alternatively, inner core portion 518 may be a viscoelastic material having a hardness that varies over time between shore a 20-A5 on the order of shore 00. In any event, the inner core portion 518 must be capable of changing shape under the sucking action of the infant such that the nipple portion 512 of the pacifier 510 conforms to the shape of the infant's mouth.

Both the dome-shaped portion of the base 514 and the base flange portion 532 of the pacifier device 510 are typically made of a tear resistant high durometer material such as the shore a30-a70 silicone rubber typically used to construct conventional pacifiers. Either the base 514 or the base flange 532 may have a hard plastic handle or guard molded thereon according to embodiments of the invention.

Another embodiment of the present invention is shown in fig. 13, which illustrates a non-nutritive pacifier device generally designated by the reference numeral 610. Similar components to those shown and described with reference to fig. 12 have been given similar numerals for ease of reference. As shown, pacifier 610 includes nipple portion 612 attached to dome-shaped base 614. In addition to the first reinforcing element 616 being constructed of a single homogeneous material as in the embodiment of fig. 12 described above, the pacifier device 610 also includes a second reinforcing element 619 that operates and is constructed in a similar manner as the second reinforcing element described above in connection with the embodiment of the nutritional feeding nipple. Distal sealing membrane 640 encapsulates inner core portion 618. In addition, the sealing film 640 may include chopped fibers of the same material as the second reinforcement film 619.

Fig. 14 plots the elongation and elongation stress of five pacifiers. The bottom three pacifiers in the table represent commercial pacifiers. Two of which are cylindrical in design, have very small domes, and differ only in stiffness. Under 15PSI elongation stress, the stiffer stretches only 3%, while the less stiff stretches 10%. Orthodontic commercial pacifiers only stretch 7% at 15 PSI. All three commercial nipple designs were very hard and had poor elongation.

The top two curves of fig. 14 represent pacifier embodiments according to the present invention. Both having a first reinforcing element of shore a10 and a second reinforcing element of polyester fiber mesh. One sample had an elastic shore A5 silicone nipple core. The sample was extended by 30% at 15PSI, more than 3 times that of the commercial pacifier tested. The second sample had a viscoelastic shore A1 silicone nipple core. The sample stretches more than 100% at 15PSI, more than 10 times the commercial pacifier tested. The pacifier according to the present invention has an elongation deformability of 3 to 10 times higher, which is expected to remodel and conform better to the shape of the infant's mouth than a typical commercial pacifier. This excellent deformability will address the published drawbacks of typical commercial pacifiers.

When extended and released, the four resilient pacifiers relax back to their original shape within a fraction of a second. When extended and released, the viscoelastic pacifier slowly relaxes back to its original shape within about 4 seconds. When tested according to the procedure of EN 14350-1,6.3, all five pacifiers tested for fig. 14 carried 30 pounds without failure.

The foregoing description of embodiments of the invention has been presented for the purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed. Obvious modifications and variations are possible in light of the above disclosure. The described embodiments were chosen in order to best explain the principles of the invention and its practical application to thereby enable others skilled in the art to utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated.

Claims (24)

1. A nutritional infant sucking device that resists bite but maintains longitudinal and lateral deformability comprising:

a solid nipple portion having a proximal end, a distal end, and a generally cylindrical outer surface, the nipple portion further having at least one conduit extending generally longitudinally from the distal end of the nipple portion to the proximal end of the nipple portion;

wherein at least a portion of the nipple portion comprises a first stiffening element extending longitudinally between the distal end of the nipple portion and the proximal end of the nipple portion and extending axially inwardly from the cylindrical outer surface of the nipple portion,

the first reinforcing element has a hardness of about shore A5 to about shore a70 and also has a characteristic and cross-sectional area sufficient to impart seizure resistance and axial strength to intended bite damage and excessive elongation by an infant user without compromising longitudinal and lateral deformability;

the nipple portion further comprises a core portion extending at least partially between the proximal end and the distal end of the nipple portion and being axially surrounded by the first stiffening element and defining the at least one conduit,

The inner core portion includes an elastomer having a hardness of about shore A1 to about shore a 20; and

a base attached at the distal end of the nipple portion and having an open interior volume contiguous with the distal end of the at least one conduit,

wherein the resulting composite nipple portion has sufficient radial deformability to permit a compressive force of 8PSI or less applied laterally by the infant's tongue to be transmitted through the nipple portion, causing the at least one conduit to collapse in compression, thereby stopping fluid flow.

2. The infant sucking device of claim 1 capable of carrying an axial load of 20 pounds for 10 seconds after being pierced across its diameter by a punch having a diameter of at least 2mm and the resulting composite nipple portion has sufficient radial compliance to shut off fluid flow under a radial compression pressure of less than 8 PSI.

3. The infant sucking device of claim 1 which is capable of passing nipple supervision test EN 14350-1,6.3 and the resulting composite nipple portion has sufficient radial compliance to shut off fluid flow at a compression pressure of less than 8 PSI.

4. The infant sucking device of claim 1 wherein the first stiffening element and the inner portion are constructed of the same material and have no geometric profile separating the first stiffening element from the inner portion and

Wherein the first reinforcing element and the inner portion have the same hardness in the range of about shore A5 to about shore a 25.

5. The infant sucking device of claim 1 wherein the first stiffening element and the inner portion of the nipple portion each comprise a material selected from the group of materials consisting of: silicone rubber, thermoplastic elastomers (TPE), and latex.

6. The infant sucking device of claim 1, further comprising a second stiffening element disposed within the nipple portion, extending longitudinally between the distal end of the nipple portion and the proximal end of the nipple portion, and radially within at least a portion of the first stiffening element;

wherein the first stiffening element and the second stiffening element each have properties and cross-sectional areas sufficient to impart the desired seizure resistance and sufficient axial strength to prevent bite damage and excessive elongation by an infant user, and wherein the resulting infant sucking device maintains radial deformability allowing a compressive force of 8PSI or less applied laterally by an infant's tongue to be transmitted through the nipple portion to cause compressive collapse of the at least one conduit to stop fluid flow.

7. The infant sucking device of claim 6 wherein the second reinforcement element provided comprises a fiber mesh tube composed of fibers extending between the proximal end of the nipple portion and the distal end of the nipple portion to provide seizure resistance to the nipple portion without applying tension or compression to the nipple portion until an elongation X is reached and reinforcement to prevent elongation failure when the elongation exceeds X,

wherein the fibers of the fiber mesh tube are at a pitch P _r An arrangement according to P _r ＝πD _r √((1-1/X)/((X ² -1) determination, wherein P _r Is the axial length required for a complete fiber wrap when the fiber tube is relaxed rather than extended, D _r Is the relaxed diameter of the fiber mesh tube and X is the length ratio of the elongated fiber mesh tube to the relaxed fiber mesh tube.

8. The infant sucking device of claim 7 wherein the fiber mesh tube is a helically wound braid to target a specific diameter D _r Is of pitch P of (2) _r About. + -. Of (1)15% arrangement.

9. The infant sucking device of claim 7 wherein the fibers of the web forming the second reinforcement element comprise polyester fibers or nylon fibers, or a moldable nylon or silicone material molded into the nipple portion in one of a solid tubular shape or a mesh pattern.

10. The infant sucking device of claim 1, wherein the base has a hardness of about shore a30 to about shore a 70.

11. The infant sucking device of claim 1, wherein an axial load applied from the base to the distal end of the nipple portion is transferred via the first stiffening element through two miter joints disposed inside and outside the distal end of the stiffening element.

12. An anti-bite but retaining longitudinal and transverse deformability infant sucking device comprising:

a solid nipple portion having a proximal end, a distal end, and a generally cylindrical outer surface;

wherein at least a portion of the nipple portion comprises a first stiffening element extending longitudinally between the distal end of the nipple portion and the proximal end of the nipple portion and extending axially inwardly from the cylindrical outer surface of the nipple portion,

the first reinforcing element has a hardness of about shore A5 to about shore a70 and also has a characteristic and cross-sectional area sufficient to impart seizure resistance and axial strength to intended bite damage and excessive elongation by an infant user without compromising longitudinal and lateral deformability; and is also provided with

The nipple portion further comprises a core portion extending at least partially between the proximal end and the distal end of the nipple portion and being axially surrounded by the first stiffening element,

the inner portion comprises a deformable material made of at least one of a soft elastomer, a viscoelastic material, or a gel capable of changing shape under the influence of the sucking of an infant; and

a base attached at the distal end of the nipple portion.

13. The infant sucking device of claim 12 wherein the nipple portion includes at least one conduit extending generally longitudinally from the distal end of the nipple portion to the proximal end of the nipple portion.

14. The infant sucking device of claim 13 wherein the nipple portion is sufficiently radially deformable to allow a compressive force of 8PSI or less applied laterally by the infant's tongue to be transmitted through the nipple portion, causing the at least one conduit to collapse, thereby stopping fluid flow.

15. The infant sucking device of claim 12 capable of carrying an axial load of 20 pounds for 10 seconds after being pierced across its diameter by a punch having a diameter of at least 2mm and the resulting composite nipple portion has sufficient radial compliance to shut off fluid flow under a radial compression pressure of less than 8 PSI.

16. The infant sucking device of claim 12 which is capable of passing nipple supervision test EN 14350-1,6.3 and the resulting composite nipple portion has sufficient lateral compliance to shut off fluid flow at a compression pressure of less than 8 PSI.

17. The infant sucking device of claim 12 wherein the first stiffening element and the inner portion are constructed of the same material and have no geometric profile separating the first stiffening element from the inner portion and

wherein the first reinforcing element and the inner portion have the same hardness in the range of about shore A5 to about shore a 25.

18. The infant sucking device of claim 12, wherein the inner core portion is capable of changing shape under infant sucking action such that the device conforms to the shape of an infant's oral cavity during sucking action.

19. The infant sucking device of claim 12 wherein the first stiffening element and the inner portion of the nipple portion each comprise a material selected from the group of materials consisting of: silicone rubber, thermoplastic elastomers (TPE), and latex.

20. The infant sucking device of claim 12 further comprising a second stiffening element disposed within the nipple portion, extending longitudinally between the distal end of the nipple portion and the proximal end of the nipple portion, and radially within at least a portion of the first stiffening element;

Wherein each of the first reinforcing member and the second reinforcing member has characteristics and cross-sectional areas sufficient to impart the desired seizure resistance and sufficient axial strength to prevent seizure damage and excessive elongation by an infant user.

21. The infant sucking device of claim 20 wherein the second reinforcement element provided comprises a fiber mesh tube composed of fibers extending between the proximal end of the nipple portion and the distal end of the nipple portion to provide seizure resistance to the nipple portion without applying tension or compression to the nipple portion until an elongation X is reached and reinforcement to prevent elongation failure when the elongation exceeds X,

wherein the fibers of the fiber mesh tube are at a pitch P _r An arrangement according to P _r ＝πD _r √((1-1/X)/((X ² -1) determination, wherein P _r When the fiber tubeRelaxing but not extending the axial length required for a complete fibre wrap, D _r Is the relaxed diameter of the fiber mesh tube and X is the length ratio of the elongated fiber mesh tube to the relaxed fiber mesh tube.

22. The infant sucking device of claim 21 wherein the fiber mesh tube is a braid wound in a spiral to target a specific diameter D _r Is of pitch P of (2) _r About + -15% of the arrangement.

23. The infant sucking device of claim 21 wherein the fibers forming the second web comprise polyester fibers or nylon fibers, or a moldable nylon or silicone material molded into the nipple portion in one of a solid tubular shape or a mesh pattern.

24. The infant sucking device of claim 12, wherein the base has a hardness of about shore a30 to about shore a 70.