Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J17/00—Baby-comforters; Teething rings
  • A61J17/02—Teething rings

Definitions

• This disclosure relates to a teether.
• Jaw movement, masticatory muscle functions i.e., feeding functions, tongue functions and eruption of the teeth have an influence on what textures are accepted or rejected. Simply put, the child knows what types of food she can eat and what types she cannot.
• muscles / joints / tongue learn to handle and coordinate the eating of complex solids. This corresponds directly with the eruption of teeth.
• This disclosure features a teether (or series of teethers) with a varied response to biting.
• the teether can replicate and coordinate this natural progression.
• the teether can achieve the various textures, firmness and compressibility of different foodstuffs. Through textures, design features and teether response the teether can replicate and coordinate the child's natural feeding and speech progression. Training the child with the teether can accelerate transitions between feeding stages and help develop control required for speech.
• the teether can be embodied in various designs that capture aspects of design that are most appropriate for the age or stage of development of the child, typically one that mimics feeding progression.
• development stages may include the following groups: Stage one- liquids (mostly sucking and oral positioning development). Stage two- soft solids (special relations and starting development of the grinding of food and swallow, early speech
• Stage three- solids (chew and focus on temporomandibular joint (TMJ) development and speech development).
• the various embodiments of the teether can include traditional teether shapes, or unique or non-traditional shapes.
• the width and thickness of biting surfaces can be varied according to tolerance at each developmental stage.
• the thickness of the portions of the teether that are designed to be bitten can change by the appropriate amount according to the age/stage of development of the child. Generally this incremental change in thickness is a 1-3 mm increase per stage, e.g., stage one may be 6- 8mm thick, stage two 8-11mm thick, and stage three 1 1-13mm thick.
• the micro behavior initial behavior when the teeth contact and start to apply a force
• the macro behavior is observed. That is to say, the berry technically behaves elastically from the time when the teeth contact the surface until the teeth break the surface tension of the skin creating an immediate plastic (non recoverable) deformation. Instead of looking at this deformation on a micro scale, it was elected to look at it in a more macro picture.
• objects like a banana, a strawberry and a small block of cheese can be used to correlate teething to teethers as these are the foods that generally follow soft purees in food progression. It would be evident to feed a child liquid and then hand the child a piece of steak (or another elastically tough food).
• Figure 10 is a Textured Profile Analysis (TP A) of a strawberry.
• the analysis is run using an Instron testing device and a specific force/displacement program to represent a bite.
• the problem is that instead of a mouth and tooth interface the test is run using two flat plates.
• the 1 and 2 displayed on the graph could correlate to bite one and bite two or could correlate to the moments at which the berry transfers from elastic to plastic and then pulp. If one looks at the graph one would see that the elastic stage of the strawberry lasts for approximately 2-3mm of displacement by the flat plate. After 2-3mm displacement and the increase in force the plastic stage takes place - the majority of the curve.
• What the testing and graph neglects to show, due to logistical limitations, is the following bites and resulting puree that exists prior to swallow. Contributing Assumptions when Examining a Child's Bite
• the angles of loading may actually be more important.
• the "C” loading angle is defined as the direction of condylar loading which occurs when the mandible is in retruded, or molar biting position.
• the protruded loading angle, "P”, is defined as the direction of condylar loading which occurs when the mandible is translated forward to a position of incisal biting or suckling.
• the mean condylar loading angle "M” is defined as a time-dependent mix of retruded loading angle and the protruded loading angle. From the following equation we are able to study the condylar loading angle and the eminence development angle as a function of age and development.
• K ratios define a constant that equals the proportion of time the condyle was assumed to be loaded in either protruded or retruded position (constant K is documented in Nickel et al, J Dent Res, June 1988).
• Prior art teether "Comp A” was selected because it seemed to include features and use construction that is representative to the majority of the currently marketed teether products.
• the polypropylene section was tested for the following reasons: 1) We believed this was the intended bite surface based on design, 2) The teether was made and marketed by one of the largest baby product companies 3) It was stated to be designed for ages 6+mos which is generally considered stage 3 (most similar to a strawberry on the feeding scale). The teether appeared to be constructed by combining injection molded parts by process of ultrasonic weld.
• Stage 1 1.5mm 50A Silicone, 3mm 25A Silicone, 1.5mm 50A Silicone.
• Stage 2 1.5mm 50A Silicone, 3mm 50A Silicone, 1.5mm 50A Silicone.
• Stage 3 1.5mm 50A Silicone, 3mm 90A Silicone, 1.5mm 50A Silicone. The testing described above was done using samples that were constructed from sheet stock material with 1.5mm thickness and durometers as specified. From the sheet stock 3" round discs were cut-out to use for compression testing. For example, the Stage 1 test teether was constructed by placing 4 of the cut-out discs of stock material together one on top of another, i.e., 1 piece of 50A silicone, 2 pieces of 25 A silicone and another piece of 50A silicone.
• Creep is a function of the entire past loading history of the specimen.
• a bite can be considered a two-step loading cycle (primary bite followed by smaller secondary bite as illustrated in figure 10) using the Boltzmann principles on projected stresses and viscoelastic response (figure below) combined with stress relaxation modulus theory (the material relationship to stress relaxation behavior as a function of time) will assure the teethers respond as intended.
• Figures 12A and 12B are a schematic model of a viscoelastic material and corresponding creep recovery curve, respectively.
• the viscoelastic material has the ability to operate as a controllable spring with a separately controlled dashpot.
• the TPA Food Texture Analysis can be used to test the foods that a developing
• C and n are constants related to food / materials properties.
• M c MiM x / (Mi + M x )
• M x the resistance to deformation of the specimen
• a visual energy balance as shown in figures 12A and 12B.
• a varied response teether comprising an outer surface created at least in part by a first elastomeric material and an inner portion comprising an elastomeric material that has at least one different property than the first elastomeric material.
• the inner portion may further comprise one or more voids.
• the restorative response of the teether may be delayed compared to the rate of the applied force.
• the restorative response of the teether may be approximately equal to that of the rate of the applied force.
• the teether materials and construction may be selected based at least in part on a viscoelastic model with a spring and damping response to applied external forces.
• the viscoelastic response may be designed to respond or react to a two stage loading of external forces, similar to a bite pattern.
• At least the outer portion of the teether may be able to rotate on an axle.
• the teether may further comprise a main body, and a ring that can rotate around the main body of the teether.
• the teether may define angled surfaces. The angled surfaces may be created by at least one peak and at least one valley.
• the inner portion may be softer than the outer portion.
• the inner portion may have a hardness of about 25 A and the outer portion may have a hardness of about 5 OA.
• the inner portion may be harder than the outer portion.
• the inner portion may have a hardness of about 90A and the outer portion may have a hardness of about 50A.
• a method of designing a teether comprising testing certain foodstuffs to determine their response to compressive force and using the test results to determine a force- responsive quality of a teether. Further featured is a teether designed by this methodology.
• Figure 1 is a simplified side cross-sectional view of a first embodiment of the teether
• Figure 2 is a simplified side cross-sectional view of a second embodiment of the teether
• Figure 3 is a simplified side cross-sectional view of a third embodiment of the teether
• Figure 4 is a simplified side cross-sectional view of a fourth embodiment of the teether
• Figures 5A-5D are views of one embodiment of the teether
• Figures 6A and 6B schematically and conceptually illustrate a variable-response construction that can be used in the teether
• Figure 7 is a simplified side cross-sectional view of an embodiment of the teether that employs the construction of figures 6 A and 6B;
• Figure 8 is a simplified partial side cross-sectional view of another embodiment of the teether that employs the construction of figures 6 A and 6B;
• Figure 9 is a graph illustrating time versus force for two bites into food, which helps to understand the varied response of certain embodiments of the teether;
• Figure 10 is a displacement/force curve for testing of a strawberry
• Figure 11 is a comparison of three teethers to a prior art teether
• Figures 12A and 12B are a schematic model of a viscoelastic material and corresponding creep recovery curve that are useful in understanding the teether designs.
• Figures 13 A and 13B show another varied response teether design.
• FIGS. 1 through 4 are schematic cross-sectional representations of four different embodiments of the teether.
• Teether 10, figure 1 includes outer shell 12 that comprises upper and lower sections 14 and 16 respectively that are made of the same durometer material, and end sections 18 and 20 that may be of a different material.
• the upper and lower sections 14 and 16 may be comprised of a 50-90 A elastomeric material, while the two end sections 18 and 20 may be a 50-60 A material.
• the softer durometer end sections are preferred so that flexing and compression does not lead to premature fatigue of the joint or living hinge that is effectively created. Because the bulk of the exterior flexing will take place at these end sections the material must be able to withstand creep deformation and repeated stress and strain cycles without failure.
• the upper and lower portions serve as interface or bite surfaces for the child.
• the purpose of these is to receive the external force applied by the gum pads or teeth and distribute that force in such a way that the internal damping / spring mechanism (a different viscoelastic material), and the end pieces are able to function as a shock absorber-like system.
• the response is controlled by the material Shore hardness and the viscoelastic responsiveness of the materials selected for the internal and end members.
• the interior 21 includes a portion of material 22 located between top and bottom 14 and 16. The rest of the interior may be of a different material or it may be empty. Material 22 is preferably elastomeric or elastomer-like. This construction creates a teether that is compressible and requires greater force as the compression proceeds.
• Portion 22 could alternatively be accomplished with a gel such as a hydro gel or a granular material such as sand.
• Embodiment 30, figure 2 also includes a shell 32 with upper and lower portions 34 and 36 made of one material and end portions 38 and 40 mat can be made of a different materia) to provide a desired response when a bite force is applied.
• interior 42 is filled with a material with the exception of one or more voids 44.
• Material 42 is preferably a different elastomer.
• Void 44 helps to accomplish a squishy feeling, but since the void is not evenly distributed across the teether, the force required to compress the teether varies in different locations on the teether. This thus accomplishes a variable bite force at different locations on the teether.
• shell 52 comprises upper and lower layers 54 and 56 and end portions 58 and 60, each of which as in the other embodiments is preferably an elastomer such as silicone.
• the elastomeric interior bridging portion 62 is connected between surfaces 54 and 56, but accomplishes variable void areas 64, 66, 68 and 70 that tailor the bite force/compressibility response of the teether at different locations and dependent on the degree of compression.
• Embodiment 80 has a slightly different cross-sectional shape and can have a generally elongated tubular shape to mimic the shape of a finger.
• Body 82 is made of one material and can have one, two or more interior volumes (two such vohunes 88 and 89 shown) of a different material and/or voids to accomplish a varied compressibility along its length.
• End regions 84 and 86 can be a different material as well.
• Teether 90 is, broadly, flat and thin. Teether 90 is constructed from elastomeric core 92 overmolded with softer silicone or similar elastomeric material 94. Outer layer 94 defines peaks and valleys (e.g., to peak 92 and valleys 93 and 97), through-hole 96 and scalloped edges 95 that accomplish angles that provide for different responses in different areas of the teether. Teether 90 will display a viscoelastic response that mimics the response of solid foods. This particular teether is designed to be for 3+ months as it is very soft and elastically responsive. This produces a response similar to pureed / rice pudding like foods.
• the soft compressive nature of the elastomeric set-up allows the child to freely bite on the teether surface, while loading the TMJ / jaw to strengthen for the next level of feeding progression.
• the angles help to alter the direction of the load on the TMJ, i.e., as in Nickel JC, et al (1988), the load and angle of load are involved in TMJ development. This will not only help strengthen the muscles and joints, but will also encourage development of the bite to be more incisor (anterior) based during initial bite.
• FIGs 6A and 6B schematically and conceptually illustrate a variable-response construction that can be used in the teether.
• Construction 100 is a stack of seven thin layers or plates 101-107 that can be arranged to be vertically aligned as shown in figure 6 A or partially misaligned as shown in figure 6B. When the layers are aligned the stack provides the greatest resistance to vertical forces, and so when used in the interior of a teether (for example a teether of the type shown in figure 1-5) construction 100 accomplishes a stiff teether, appropriate for older children. As the plates are moved to become more misaligned as illustrated for example in construction 100a figure 6B, the stack exhibits greater vertical compliance and so can
• the material, construction and thickness of the individual plates can be tailored to achieve a desired elastic or viscoelastic response to compressive forces. The result is that a stack such as this can be used to accomplish different response to compressive forces as a means to at least partially accomplish an aim of the teether.
• this stack concept can be applied to the teether literally, or more conceptually.
• the stack can be arranged and then tested (for example using an Instron tester), as a means to determine proper design of a unitary or integral interior elastic member of the type shown in figure 1-5.
• Teether 1 10, figure 7 uses "spring” 112 to provide some or all of its compliance.
• Spring 112 comprise interconnected intersecting strings 1 13 and 1 14 of plates (or a construction modeled by plates) to accomplish a certain compliance.
• the material, length, thickness and/or angles (and relative angles) of strings 1 13 and 114 can be varied to accomplish a desired elastic or viscoelastic response.
• FIG. 8 Yet another broadly similar embodiment 120 is shown in figure 8.
• internal hollow channel 126 is employed to contribute to the compliance.
• Plate string (or equivalent) 122 is located between hollow or filled channel 126 and upper surface 123, and string (or equivalent) 124 is located between lower surface 125 and channel 126.
• Figure 9 is a force diagram of the biting force realized as food is chewed. This graph reflects the fact that force per bite decreases as the food is masticated.
• the variable response teether of this invention can mimic this type of force profile through selection of design, materials and placement of the teether by the infant/toddler.
• Figures 13 A and 13B illustrate a teether 200 that has multiple bite surfaces and is comprised of a main planet like structure 202 that has two elastomeric overmolded sections 204 and 212 for bite response and an outer orbit ring 206 that is allowed to rotate freely around the planet due to an axle like structure 208 that connects the two parts.
• Structure 202 carries peg 232 and peg-receiving cylinder 231.
• the other half of teether 200 (not shown in figure 13B) has a mirror image construction to create two peg in cylinder press fit structures that hold the two halves of planet 202 together while they are ultrasonically welded together along seam area 201.
• Both planet structure 202 and section 204 have an internal structure that is similarly shaped and typically (but not necessarily) of different hardness (typically harder) than the overmolded sections to accomplish structure for the overmolding as well as contribute to the bite response.
• the dimensions of the outer orbit ring 206 are such to allow the infant to bite around the ring, i.e., can close their lips around the ring to accomplish a lip seal gesture; the act of sealing the lips around an item or object allows one to hold food or liquids in the mouth without spilling.
• ring 206 being spaced from planet 202 provides an open area for hand-eye coordination and acts as a handle.
• the planet 202 can spin about axle 208 via discs 221 and 222 on axle 208 and matching plates with central openings 223 and 224 on the inside of planet 202 that allow discs 221 and 222 to float while limiting vertical movement and allowing planet 202 to spin freely about axle 208.

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• Health & Medical Sciences (AREA)
• Pediatric Medicine (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Food-Manufacturing Devices (AREA)
• Medical Preparation Storing Or Oral Administration Devices (AREA)
• Laminated Bodies (AREA)
• Absorbent Articles And Supports Therefor (AREA)
• Slide Fasteners, Snap Fasteners, And Hook Fasteners (AREA)
• Dental Tools And Instruments Or Auxiliary Dental Instruments (AREA)

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• 2011
  • 2011-02-01 EP EP11737850.5A patent/EP2531166A4/en not_active Withdrawn
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  • 2011-02-01 US US13/018,663 patent/US20110178550A1/en not_active Abandoned
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• 2017
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