COMPLIANT INFANT SUCKLING DEVICE
Nutritive and non-nutritive suckling devices made entirely of a soft, highly deformable elastomer includes a completely and/or partially filled nipple portion constructed of a low durometer elastomer. For nipple feeding, one or more ducts longitudinally extend through the completely-filled nipple portion. The nipple portion has sufficient axial strength to pass biting and elongation failure in regulatory testing yet is sufficiently radially compliant that a <8 PSI transverse compressive pressure can compress the nipple duct(s) to shut off fluid flow. An attachment design allows the soft highly deformable elastomer of the nipple base to resist detachment from the bottle collar when screwed onto the bottle under >20 pounds axial load. A non-nutritive pacifier device includes a completely-filled nipple portion having an open interior volume portion with a wall thickness adjusted to replicate the feel of a human nipple and an areola wall thickness sufficient to resist collapse during use.
1 . A device for nutritive infant suckling comprising:
a nipple portion having a proximal end, a distal end, and an exterior surface, and further defining:
a filled portion wherein said nipple portion is filled along a longitudinal portion of the length of said nipple portion from the proximal tip thereof toward the distal end thereof and further defining at least one duct extending generally longitudinally through the filled portion of the nipple portion, and
a partially filled portion wherein said nipple portion is partially filled along a longitudinal length extending from the distal end of the filled portion to the distal end of the nipple portion, said partially filled portion defining an open interior volume that is contiguous with a distal end of the at least one duct, and
an areola portion connected to the nipple portion at the distal end thereof, wherein said areola portion defines an open interior volume contiguous with the open interior volume of the partially filled nipple portion, and
wherein said nipple portion and areola portions are both constructed of a single low durometer elastomer having a hardness of about Shore A1 to about Shore A30.
2 . The device for nutritive infant suckling according to claim 1 , wherein said nipple portion and areola portions are both constructed of a single low durometer elastomer having sufficient radial compliance to allow shut off of fluid flow through the at least one duct with <8 PSI transverse compressive pressure.
3 . The device for nutritive infant suckling according to claim 1 , wherein the at least one duct reduces in cross-section from the distal end of the filled portion of the nipple portion to the proximal end of the filled portion of the nipple portion, wherein said reduction in cross-section comprising at least one of a gradual reduction of diameter or a stepped diameter reduction.
4 . The device for nutritive infant suckling according to claim 3 , wherein the largest cross-sectional diameter of the at least one duct is located at the distal end of the filled portion of the nipple portion and the smallest cross-sectional diameter of the at least one duct is located at or proximate to the proximal end of the filled portion of the nipple portion.
5 . The device for nutritive infant suckling of claim 4 , wherein the at least one duct further comprises one or more intermediate duct sections positioned between the largest and smallest cross-sectional diameter section, each said one or more intermediate duct sections having respective cross sections with diameters between the largest and smallest cross-sectional diameters.
6 . The device for nutritive infant suckling according to claim 3 , wherein the at least one duct includes a flow control zone having a cross-sectional diameter smaller than the cross-sectional diameters of all other sections of said at least one duct.
7 . The device for nutritive infant suckling according to claim 6 , wherein the flow control zone of the at least one duct is located at or proximate to the extreme proximal end of the filled portion of the nipple portion.
8 . The device for nutritive infant suckling according to claim 1 , further comprising a base portion constructed of a single low durometer elastomer having a hardness of about Shore A1 to about Shore A30, which is connected to the distal end of the areola portion and configured for connection, by a collar, to sealingly attach said base portion to a container designed to contain fluid to be fed to an infant, and
wherein the attachment configuration between base portion, collar and bottle is capable of carrying a 20-pound axial load without the teat base portion pulling out of the collar and becoming detached from the container.
9 . The device for nutritive infant suckling according to claim 8 , wherein the nipple portion, the areola portion and the base portion are all constructed of the same single elastomer having a hardness of about Shore A1 to about Shore A30.
10 . The device for nutritive infant suckling according to claim 1 , wherein said device having sufficient axial strength in compliance with the mechanical strength requirements of at least one of (i) U.S. nipple regulatory test 16 C.F.R. Section 1500.51(c); and (ii) Section 7.7.1 of European regulatory standard EN 14350.
11 . The device for nutritive infant suckling according to claim 10 , having sufficient radial compliance to allow shut off of fluid flow through the at least one duct with <8 PSI transverse compressive pressure.
12 . The device for nutritive infant suckling according to claim 1 , wherein the low durometer elastomer comprises a silicone.
13 . A device for non-nutritive infant suckling comprising:
a nipple portion having a proximal end and a distal end and comprising a section along its longitudinal length between the proximal end toward the distal end thereof that is completely filled but for an open interior volume defined in a longitudinal distal portion of the completely filled section, said open interior volume having a diameter between about 2 mm and about 6 mm; and
an areola portion connected to the nipple portion at the distal end thereof, wherein said areola portion defines an open interior volume,
wherein the open interior volume of said areola portion is contiguous with the open interior volume of the nipple portion, and
wherein said nipple portion and areola portion are both constructed of a single low durometer elastomer having a hardness of about Shore A1 to about Shore A30.
14 . The device for non-nutritive infant suckling according to claim 13 , further comprising a mouth shield portion connected to a distal end of the areola portion.
15 . The device for non-nutritive infant suckling according to claim 14 , wherein the mouth shield portion comprises a 2-layer construction having a proximal top layer and a distal bottom layer,
wherein the proximal top layer of said mouth shield portion is constructed of a single low durometer elastomer having a hardness between about Shore A1 to about Shore A30 such that the nipple portion, the areola portion and the proximal top layer of the mouth shield portion are all constructed from the same single elastomer.
16 . The device for non-nutritive infant suckling according to claim 15 , wherein said distal bottom layer is constructed of a material having a hardness greater than the nipple portion, the areola portion and the proximal top layer of the mouth shield portion.
17 . The device for non-nutritive infant suckling according to claim 16 , wherein the distal bottom layer of the mouth shield portion is constructed of silicone or hard plastic.
18 . The device for non-nutritive infant suckling according to claim 15 , wherein one of the first proximal top layer and the second distal bottom layer of the mouth shield wraps around the outer edge of the other of the first proximal top layer and the second distal bottom layer of the mouth shield.
19 . The device for non-nutritive infant suckling according to claim 15 , wherein a handle or tab extends distally from the second distal bottom layer of the mouth shield and is constructed of the same material as the second distal bottom layer of the mouth shield.
20 . The device for non-nutritive infant suckling according to claim 13 , wherein the nipple and areola portions have properties and cross-sectional areas sufficient to pass puncture of the nipple/areola portion with a 3mm punch followed by a 20-pound axial pull for 10 seconds.
21 . The device for non-nutritive infant suckling according to claim 13 , wherein the nipple and areola portions of said device have sufficient axial strength in compliance with the mechanical strength requirements of at least one of (i) U.S. pacifier regulation 16 CFR 1511; and (ii) European pacifier regulatory standard EN 1400.
22 . The device for non-nutritive infant suckling according to claim 13 , wherein the low durometer elastomer comprises a silicone.