Injection molded TPE (Thermoplastic Elastomer) teat or pacifier having Shore hardness of 30 A to 40 A

Abstract

An injection molded TPE (Thermoplastic Elastomer) teat (2, 13) based on a styrene block copolymer or a pacifier (1) with a teat (2, 13) having a Shore hardness A of between 30 and 40 is disclosed. A nipple (2, 13) or a pacifier (1) with a nipple (2, 13) comprises a nipple tip material (14) and a nipple edge locking material (15) at the bottom of the nipple (2, 13), intended to fit into a shield (3) and to be locked in position by a grip (4) and a locking portion (17) above a hole (16) on the back of the nipple (2, 13); alternatively, the teat (2, 13) is provided with a shield (3) at the end of the teat (2, 13) and an edge grip (5) on the back (7) of the shield (3), which are integrally formed from TPE. The teat material portion (2, 13) is the thinnest material portion in the range of 0.5 mm to 1.5 mm, and the shield (3) and the grip (4) are thicker than the teat material (14). The TPE nipple or pacifier is a substitute for known natural rubber and silica gel nipples or pacifiers. The TPE material is unvulcanized and thus free of harmful materials, such as nitrosamines and formaldehyde. The pacifier can be repeatedly used. The teat / pacifier has a perfect combination of tear strength and tensile strength and provides bite resistance at 40 A Shore hardness. TPE blends having a Shore hardness of 37.5 A have passed the tests for tear and bite. Since TPS (thermoplastic elastomer based on styrene block copolymer) is lighter, the pacifier / pacifier has reduced weight.

Description

Technical Field

[0001] This invention relates to a pacifier / sugar baby made from a recyclable thermoplastic elastomer (TPE) based on a styrene block copolymer, which remains strong, safe, and soft enough for pacifier use. When children are 0-3 years old, normal pacifiers will be used for extended periods during the day. This is why the Shore hardness of the material is very important while ensuring the product does not harm children. The invention of this pacifier / sugar baby stems from an understanding of the chemically-containing vulcanization processes of all latex rubbers and silicones used in the manufacture of pacifiers / sugar babies specifically for children. Latex, silicone, and rubber typically have a Shore hardness rating of around 40A, while we have been pursuing a very low Shore hardness of 30A-40A while still retaining all the properties required for pacifier use. All natural rubber, natural latex, rubber, or silicone is vulcanized.

[0002] Silicone and rubber materials have high application value after vulcanization. Their mechanical properties are greatly improved, and they have characteristics such as non-stickiness, not easy to break, elasticity, high temperature resistance, high tensile strength, and insolubility in water and organic solvents.

[0003] Natural rubber, natural latex, and synthetic silicone rubber all require vulcanizing agents for vulcanization.

[0004] Silicone rubber vulcanization is divided into two stages: The first stage involves mixing raw materials such as rubber, reinforcing agents, additives, vulcanizing agents, and structure control agents to obtain silicone and rubber raw materials, which are then deployed as semi-finished materials. The second stage involves molding the raw materials and finished products into hardware through processes such as thermoforming, extrusion, injection molding, etc., using machining stress and product catalytic solidification, followed by high-temperature molding. Here we mention some well-known accelerators still used in vulcanization processes in 2023.

[0005] Applicant (D1) WO97 / 49352 A1 (GILLETTE CANADA) 31 / 12 / 1997 mentions a Shore 37A TPE material, but this application relates to dental floss with a thermoplastic coating, which has less strength than that required for pacifiers. Pacifier TPEs must pass the EN 1400 standard (see Background Art of the Invention | 27-30), which tests occlusal and tear strength, while dental floss coatings cannot pass this test.

[0006] Another applicant, (D2)WO 2005 / 087867 A1 (GLS CORP) 22 / 09 / 2005, describes block copolymer compositions for overmolding any nylon, but similarly has nothing to do with common uses such as pacifiers / nipples, where bite resistance and tear resistance are very important and must pass the tests with respect to standard EN EN1400:2013+A2:2018.

[0007] D3 is a company that sells TPE materials - RTP Company: Product Data Sheet and General Processing Conditions RTP 2700 S-30A Similarly, this is not intended for pacifier / nipple material use, as this TPE does not meet the EN1400 standard for pacifiers.

[0008] The trade name of the vulcanizing agent still used in the vulcanizing industry.

[0009] Magnesium oxide and zinc oxide = (Exposure to magnesium oxide can cause "metal fumes fever," a flu-like illness with symptoms including a metallic taste in the mouth, headache, fever and chills, aches, chest tightness, and cough. Zinc oxide can cause symptoms if ingested or its fumes are inhaled. Local skin irritation and allergic reactions may occur in individuals with chemical sensitivities.) Hexamethylenediamine (HCM) is a corrosive chemical that can severely irritate and burn the skin and eyes upon contact and may damage the eyes. Breathing hexamethylenediamine may irritate the nose, throat, and lungs, leading to chest tightness and / or difficulty breathing. Proprietary metal oxides = (almost all metal oxide nanoparticles used in commercial applications are generally considered safe at low concentrations because there is no overwhelming evidence to the contrary) tert-butyl perbenzoate = (Danger! According to the classification provided by the company to ECHA in its REACH registration, this substance is extremely toxic to aquatic life. It is harmful if inhaled, has long-lasting effects on aquatic life, may cause fire if heated, and may cause skin irritation and allergic skin reactions.) Dicumyl peroxide = (Hydrogen peroxide is an oxidizing chemical present in many household and industrial environments. It is generally safe at household concentrations (typically around 3%), but can be dangerous if used improperly. Industrial concentrations (typically up to 70%) can lead to significant mortality and death rates.) Calcium carbonate (calcium carbonate is the active ingredient in agricultural lime and is produced when calcium ions in hard water react with carbonate ions to form scale. It has medical uses as a calcium supplement or as an antacid, but excessive consumption can be dangerous and cause hypercalcemia and digestive problems.) Silica = (Because it is as small as 1 / 100th the size of a grain of sand, it can be inhaled unknowingly. Exposure to silica dust can lead to the development of lung cancer, silicosis (irreversible scarring and hardening of the lungs), kidney disease, and chronic obstructive pulmonary disease.) tert-butyl maleate peroxide = (Exposure may cause headache, dizziness, drowsiness, confusion and fainting. Dangerous fire hazard. OSHA: The statutory permissible airborne exposure limit (PEL) is 100 ppm over an 8-hour work shift.)

[0010] tert-Butyl peroxide = (tert-butanol has low systemic toxicity at single doses, but is irritating to the skin and eyes; high oral doses produce ataxia and hypoactivity, and repeated exposure can induce dependence.) Sulfur = (Sulfur has low toxicity to humans. However, excessive sulfur intake may cause a burning sensation or diarrhea. Inhaling sulfur dust can irritate the airways or cause coughing.) N-oxodimethylbenzothiazole-2-sulfinamide = (The recognized toxicity associated with thioamides and thioureas leads to the speculation that thiazole toxicity is attributable to ring cleavage producing the corresponding thioamide metabolites

[174] . Ring opening has also been observed in benzothiazoles. (treated insoluble sulfur oil.) Benzoyl-p-quinone dioxime = (Repeated eye exposure can lead to tanning and / or corneal deformities and decreased vision). p-Benzoquinone can irritate the lungs. Repeated exposure may lead to the development of bronchitis, accompanied by cough, sputum, and / or shortness of breath. p-Benzoquinone may affect the kidneys) Hexamethylenediamine carbamate = (Hexamethylenediamine is a corrosive chemical, and contact with it can severely irritate and burn the skin and eyes, and may damage the eyes.) Breathing hexamethylenediamine may irritate the nose, throat, and lungs, causing chest tightness and / or difficulty breathing. However, N,N'-dicinimino-1,6-hexanediamine may also have potential toxic effects on cells and tissues. Studies have shown that N,N'-dicinimino-1,6-hexanediamine can induce oxidative stress and DNA damage in cells, which may lead to cell death and tissue damage. Therefore, further research is needed to determine the potential therapeutic and toxic effects of N,N'-dicinimino-1,6-hexanediamine.

[0011] 1,6-Hexanediamine, Lead Oxide = (Acute toxicity - Class 4; H302 (Harmful if swallowed) Acute toxicity - Class 4; H312 (Harmful upon skin contact) Specific target organ toxicity (single exposure) - Class 3; H335 (May cause respiratory irritation) Skin corrosion - Class 1B; H314 (Causes severe skin burns and eye damage).

[0012] The pacifier industry has been producing pacifier nipples for over 130 years and still uses vulcanized latex, rubber, and silicone. Furthermore, the legal standard for pacifiers, EN1400:2013+A2:2018, which serves as the standard for pacifiers, states that both rubber and silicone leave traces of certain chemicals (see below).

[0013] formaldehyde N-nitrosamine N-nitrosamines mercaptobenzothiazole release Antioxidant release Volatile compound content These are the chemicals permitted in pacifiers in 2023. As long as the pacifier material and pacifiers made of rubber, latex, and silicone are below certain levels of these documented harmful chemicals, there is no problem. Vulcanization allows these chemicals to be vulcanized, indirectly introducing the aforementioned harmful materials into the baby's mouth.

[0014] If asked under oath: "Does this rubber, silicone, or latex pacifier contain formaldehyde and nitrosamines?" Saying no is lying! Our goal is to change this by using better materials, such as TPE = unvulcanized, which means it contains none of the chemicals mentioned and is still as good as pacifiers known over the past 130 years.

[0015] However, pacifiers made from thermoplastic elastomers (TPEs) have always faced significant challenges: making them soft enough to rival silicone and latex rubber, and meeting requirements in terms of temperature stability, moldability, tear strength, and tensile strength. This is precisely why latex, rubber, and silicone have not yet been replaced.

[0016] We have been working with TPE for over 16 years, during which time TPE (TPS) has changed significantly. We now see better TPS (TPE) materials that are stronger and better, and are now soft enough to be used as pacifiers / nurses.

[0017] In the sex toy industry, TPE also poses a challenge to silicone, rubber, and latex because TPE has lower production costs and is 100% recyclable. Rubber and silicone, on the other hand, cannot be recycled.

[0018] For this purpose, we have tried time and again to manufacture the right TPE blends for pacifiers / nipples, which challenges the performance of silicone and rubber at all levels.

[0019] Many prototypes have been built and testing continues. Now we have the first pacifier / sugar baby nipple that is soft and sturdy enough for everyday use as a pacifier / sugar baby nipple, and not just a disposable pacifier, nor a true pacifier for infants / children in the 0-4 year age group or when a pacifier is no longer needed. It is bite-safe, good, and soft.

[0020] This work is underway on new TPE injection-molded nipples or pacifiers of Shore 30A to Shore 40A.

[0021] TPS (TPE) with a Shore A of 30-45 has been tested, and it has been found that pacifiers with a hardness exceeding Shore A 40A will not pass the test and cannot be used as pacifiers. They will simply be too hard for children and may have side effects such as increased fatigue in and around the mouth and making it difficult for teeth to erupt naturally. Furthermore, if used for a long time, if the pacifier's hardness exceeds 40A, it may damage and / or cause mouth muscle soreness and headaches.

[0022] Our TPE is real-world tested and features a true pacifier / nipple design. A pacifier must be Shore 40A or lower – anything higher than Shore 40A will not be used as a pacifier because it is too hard for an infant or child to remain in their mouth for an extended period. The material must be as natural as possible, and a real breast / nipple will be close to Shore 40A and lower; therefore, a pacifier harder than Shore 40A makes no sense and cannot be used for pacifier purposes.

[0023] Applicant WO2009009372A1 - TPE compositions with good transparency and low hardness and articles formed therefrom.

[0024] WO2009009372A1 describes all the benefits of TPE compared to silicone. The invention mentions several aspects in its formulation where they have managed to prepare TPE that address low hardness while maintaining excellent transparency, low haze, temperature stability, moldability, tear strength, and tensile strength.

[0025] WO2009009372A1 has been mentioned many times for its low hardness and that it is lower than Shore 45A, but how low is it? The applicants mentioned "good transparency" in their invention, and that feature is not our priority.

[0026] In the description of WO2009009372A1 points 0009, 0010, 0014, and 0015, the applicant discussed Shore A45 or lower. If the applicant for WO2009009372A1 were already at 40A or lower, they would certainly have mentioned this, as it is one of the weaknesses of TPE compared to silicone in the past.

[0027] It is mentioned at point 0012, WO2009009372A1.

[0028] Therefore, it is desirable to have a TPE composition that has a Shore hardness below 45A while still maintaining the desired level. Its transparency, haze, temperature stability, moldability, tear strength, and tensile strength. If it is just below Shore A 45, it cannot be used for pacifier / nipple purposes. It can be used for bottle nipples and for biting articles as described in this application, but for pacifiers / nipples, it must be at least as low as Shore A 40A or lower, as we do in our invention using blends of TPE made from thermoplastic elastomers based on styrene block copolymers.

[0029] Applicant WO2009009372A1 describes tested articles with thicknesses of 1.7mm and 3.5mm in document 0014. This indicates that the invention in WO2009009372A1 did not consider pacifier design during testing, because the thickness of pacifiers and pacifier nipple designs does not exceed 1mm-1.5mm, and since children cannot use thicker materials for sucking, it would not work. It might be suitable for bottle nipples and as a child's biting product when used only for short periods, but pacifiers present a different problem.

[0030] The test for the plague is described in WO2009009372A1.0033. This certainly indicates that the applicant only tested for the plague and not for the actual product (pacifier), where the pacifier's stiffness is crucial. Furthermore, the applicant focused on the transparency of the TPE, and this characteristic would certainly compromise softness, as additives added to the TPE blend to achieve transparency also eliminate some softness. In this invention, softness is more important than the transparency of the pacifier / pacifier material.

[0031] The invention described by the applicant is unsuitable for use as a pacifier because it is not soft enough.

[0032] A TPE material has been developed for pacifiers with Shore A 30-40, and this is suitable for infants, not Shore 45A. The TPE must be Shore 40A or lower, no higher. Our TPE has been tested for some time, and pacifier users can easily distinguish the difference between Shore 40A and 45A.

[0033] There are also significant differences between tests on the plague and tests on actual pacifiers. The TPE pacifier described in our application has a nipple thickness of only 1mm-1.5mm. This is why we have an invention and a new TPE blend that fulfills all the necessary requirements for pacifier use—good transparency is not 100% transparent, but milky, and a transparent TPE can be developed later, but it has now achieved temperature stability, moldability, tear strength, and tensile strength, and its bite performance has been proven.

[0034] Today's pacifier manufacturers typically source silicone or latex / rubber nipples from external manufacturers. If the manufacturer manufactures the shield and grip internally, where do they obtain the nipple parts made of TPE? Our TPE blends have now passed internal testing and we can supply this new TPE nipple and TPE pacifier with Shore 40A, which is not possible today.

[0035] Applicant US 2004 / 0220323 A1 mentions an invention on page 1, 003, 004, and 005. This invention relates to the manufacture of a transparent silicone baby bottle nipple.

[0036] Page 1-002 The goal is to replace silicone with a thermoplastic, injection-moldable copolymer, while providing a product that aligns with the target... Organosilicon has essentially the same physical properties. Page 1-003 "Silicone with the aforementioned desired properties is used in high-quality oral medications because silicone can be formulated..." It possesses the desired physical properties and is also essentially transparent. Being visible through the nipple body makes it easy for caregivers to check. The nipple body appears clean, and when used to feed an infant, it is easy to determine whether the infant is using the nipple or milk. The bottle nipple draws in liquid... When viewing this application Figure 1 and Figure 2 The accompanying diagram shows a nipple for a baby bottle, and that the nipple should be made as transparent as possible and as close to silicone as possible.

[0037] Page 1, page 003; The expected properties of typical "pacifier-grade" silicone are as follows: tensile strength close to 6.9 MPa. (1000psi); tear resistance close to 35N / mm (200lb / in); heat resistance, able to withstand sterilization temperatures close to 100°C. No damage. Loss of dimensional stability; hardness not greater than Shore A 65; and insufficient haze to provide "transparent" transparency, thereby improving... Provides a visual indicator of cleanliness. Although haze and transparency are measured differently, this article only measures haze, based on the fact that there is essentially no... With a haze of less than 20%, it provides a virtually transparent injection-molded material. The combination of tear strength and tensile strength provides durability. Biting action. The applicant, US 2004 / 0220323 A1, describes a nipple for a feeding bottle rather than a pacifier, because the Shore hardness of a pacifier should not exceed Shore 40A, and when attempting to manufacture transparent TPE, they must add vinyl and / or PP—how to add PP and / or vinyl to TPE blends to make them strong enough and transparent is mentioned on pages 1-005 and 006.

[0038] Compared to silicone, the material they demonstrated and described is perfect as a substitute for bottle nipples, but for pacifiers, Shore A 55 is too hard, as they described, so they can see and check whether the bottle nipple is clean and whether the baby is feeding.

[0039] 0019 Discuss feeding.

[0040] "Provides properties that mimic those of soft, tough, transparent silicone used in baby bottle nipples." "properties" "Designed to be held in an infant's mouth, or in medical catheters and related products that come into contact with bodily fluids during use." This makes sense when the applicant, US 2004 / 0220323 A1, describes a nipple for use in feeding a baby bottle. Additionally, it is relevant when used as a bite ring.

[0041] The bottle nipple and bite ring are suitable for Shore A45-55 use. The applicants describe their invention as transparent, and when the transparency of the material is desired, it is difficult to go below Shore A 45, as they describe in Table 1 on page 7.

[0042] The applicant, US 2004 / 0220323 A1, does not describe the invention as a pacifier, and the drawings do not even show a single pacifier for assembly purposes using a common pacifier made of a PP shield and a handle.

[0043] We have already injection molded several types of 100% TPE pacifiers made from thermoplastic elastomers based on styrene block copolymers in our own testing tools.

[0044] The tests clearly show that Shore 40A is the highest range on the Shore scale. If the hardness is greater than Shore 40A, it will not function properly as a pacifier. Compared to silicone and latex rubber, children will not use TPE pacifiers / pacifiers if the hardness is greater than Shore 40A.

[0045] That's why we only manufacture pacifiers / nurses with Shore A 30 to Shore 40A ratings, and it's novel.

[0046] We supply silicone and latex / rubber pacifiers to other manufacturers to obtain individual pacifiers made from our TPE blends, and they can still use the same manufacturing facilities they normally assemble their pacifiers by assembling the silicone / latex / rubber pacifier into the shield and closing it with the locking part on the back of the shield. Now they only need to change the pacifier part to this new TPE pacifier, which is Shore 40A or lower.

[0047] Our TPE injection-molded nipples or pacifiers are made of TPE. HSBC elastomers can be used in many types of applications; the choice of using SEBS, SEPS, or SEEPS depends on the formulator and the desired final properties.

[0048] HSBC types were developed from SBC, which have undergone hydrogenation processes that eliminate almost all unsaturation; for this reason, they are more resistant than SBC and can be classified as SEB, SEP, or SEEP.

[0049] The elastomers we use are all styrene block copolymers because they are all based on styrene and they have a “block” structure. Specifically, our elastomers have three “blocks,” the first and last of which are made of styrene, and the middle one can be, depending on the chemistry of the monomers: -B=Butadiene -I=Isoprene (which provides vinyl groups, but they are unsaturated) -E = Ethylene Even though our TPE is as soft as Shore 30A-40A, we can still etch patterns into tools for products such as pacifiers / nipples, and the material will show different visual effects on the shield or on the nipple of the pacifier.

Claims

1. A TPE (thermoplastic elastomer) nipple (13) or a pacifier (1) with a nipple, characterized in that... It is based on a styrene block copolymer with a Shore A hardness between 30 and 40, wherein the nipple or pacifier having the nipple comprises a nipple tip material (14) and a nipple edge locking material (15) located at the bottom of the nipple (13) for fitting into a shield (3) and locking in place by a grip (4) and a locking part (17) above a hole (16) on the back of the nipple (13); or wherein the nipple is integrally formed with the shield (3) at the end of the nipple (2) and the edge grip (5) on the back of the shield (7), wherein all areas including the shield (3), the grip (4) and the nipple (2) are made of TPE having a varying thickness, wherein the nipple material portion (2, 13) is the thinnest material portion with a thickness ranging from 0.5 mm to 1.5 mm or more, and the shield (3) and the grip (4) are thicker than the nipple material (2).

2. The injection-molded TPE nipple or pacifier according to claim 1, comprising a color-changing TPE material in the nipple (2, 13) and / or the shield / grip (3, 4, 5), wherein the material changes color when the temperature in the mouth of the infant using the nipple or pacifier is above 37 degrees or, if preferably, lower, indicating whether the infant has a fever.

3. The injection-molded TPE nipple or pacifier according to claim 1, comprising a phosphorescent material that makes the pacifier / nipple luminescent in the dark visible even when the lights are off, but invisible when used in the dark.

4. The injection-molded TPE nipple or pacifier according to claim 1, comprising a pattern etched into the surface of the shield material (7).

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