US3394018A

US3394018A - Package-nurser

Info

Publication number: US3394018A
Application number: US554254A
Authority: US
Inventors: Velonis Stamatis George; Henry M Richardson; Wesley S Larson
Original assignee: Medics Res and Development Inc
Current assignee: Medics Res and Development Inc
Priority date: 1966-05-04
Filing date: 1966-05-04
Publication date: 1968-07-23
Anticipated expiration: 1985-07-23

Description

July 23, 1968 s, VELONIS ET AL 3,394,018

PACKAGENURSER 4 Sheets-Sheet 1 Filed May 4, 1966 2 MOI S338 j 2 9 Q pkw lNVfA/TORS STAMAT/S GEORGE VELON/S HENRY M. RICHARDSON WESLEY .S. LARSON .BY @(a mo' fwd 62120:75

July 23. 1968 VELONIS ET AL 3,394,018

PACKAGE-NURSER Filed May 4, 1966 4 Sheets-Sheet 2 El. 1 i- //V VEN TOPS .STAMATIS a o/m2 VELON/S I 8 HNRY M- R/CHARDJON WESLEY 5. LARSON 5. 5. VELONIS ET AL 3,394,018

PACKAGE -NURSER 4 Sheets-Sheet 5 Mann?! July 23, 1968 Filed May 4, 1966 M ma Sink m V WE a ma fi lllll 1 Ii!!! mm; A 2M RWNUQNKW w u U QM .ll W w W W. UN-WQ QM HQ$ ktwh 5km vSHm .533 p y 1958 s. G. VELONIS ET AL $394,018

PACKAGE NURSER 4 Sheets-Sheet 4 Filed May 4, 1966 United States Patent 3,394,018 PACKAGE-NURSER Stamatis George Velonis, Opportunity, Wash., and Henry M. Richardson, Somers, and Wesley S. Larson, Hazardville, Conn, assignors t0 Medics Research and Development, Inc., Spokane, Wash., a corporation of Washington Continuation-impart of application Ser. No. 344,282, Feb. 12, 1964. This application May 4, 1966, Ser. No. 554,254

4 Claims. (Cl. 99-171) ABSTRACT OF THE DISCLOSURE A disposable, steam sterilizable nippled infant feeding device formed from an elastomer-modified polyallomer having a flexural modulus of not greater than l.O 1O psi. The portion of the feeding device adjacent the nipple is made more form stable than the remainder of the feeding device.

This is a continuation-inpart of copending application Ser. No. 344,282, filed Feb. 12, 1964, now abandoned.

BACKGROUND In feeding infant, both at home and in the hospital, it has long been desired to simpily the operations associated therewith including preparation of formula, transfer from one container to another, terminal sterilization of the bottles, nipples, etc., and assembly of the nurser components. Various prior packaging proposals have been deficient for one reason or another. For example, in one system the nurser cannot be steam sterilized, in another the nurser is composed of a number of separate parts which must be assembled. In another type the air sucking problem is not solved although this problem was recognized in Patent No. 554,071. In this patent is shown a nursing bottle consisting of a glass top and a flexible rubber bag which collapses as milk is withdrawn from the bottle; a nipple is removably mounted on a neck extending from the glass top. Nursing bottles of the type disclosed in this patent have never received commercial acceptance, however, apparently because the rubber bag was too flexible and subject to being dislodged by the baby during nursing. More recently a nurser has been marketed which comprises a pliable bag contained in a rigid holder enabling the liquid containing bag or liner to be handled. While this nurser is intended to solve, in a practical way, the problem of swallowed air, it is composed of a multiplicity of separate elements which must be assembled and filled before use in the manner of a conventional baby bottle. There have also been a number of disposable nursing units proposed, but for various reasons none of these has proved commercially acceptable.

It is an object of this invention to provide an improved method of packaging and dispensing baby fromula.

It is another object of this invention to provide a nurser which serves as both retail package and nursing container. Moreover, the nurser is wholly flexible, break resistant, and overcomes the problem of air intake. In addition the contents of the package, once sterilized, will remain sterile until opened.

It is a further object of this invention to provide throwaway, hermetically sealed and steam sterilizable nurser of unitary construction.

It is also an object of this invention to provide a flexible nurser of the above type having a nipple configuration which promotes proper orthodontic development in infants using the nurser, and thereby greatly minimizes the incidence of malocclusions and need for orthodontic treatment so common in todays bottle-fed children.

The above and other objects of this invention will be more readily apparent with the following description and with reference to the accompanying drawings in which:

FIG. 1 is a diagrammatical view showing a method of manufacturing a nurser-package in accordance with this invention;

FIG. 2 is a perspective view showing a packaged nurser embodying this invention;

FIG. 3 is an elevational view illustrative of operational features of the nurser;

This is a continuation-in-part of copending applicasuitable for use on nurser-packages embodying this invention;

FIG. 5 is a cross sectional view of an alternate type of nipple construction;

FIG. 6 is a diagrammatical view showing an alternative method of manufacturing a nurser-package in accordance with this invention;

FIG. 7 is an elevational view showing an alternative form of nurser embodying this invention;

FIG. 8 shows one form of carrier or container for the nurser of FIG. 7; and

FIG. 9 shows an alternative carrier for the nurser.

Referring to details of the drawings, in FIG. 1 is shown one method of preparing packaged baby formulas in accordance with this invention. In the embodiment shown, polyallomer, synthetic plastic sheet material is unwound from a pair of rolls 4 and 6. The webs of

plastic

8 and 10 are lead through a heating chamber, such as shown at 12, which is maintained at a temperature such that at their rate of advance the Webs are softened sufiiciently to be thermoformed in the vacuum former 13 to provide

shells

14 and 16 extending outwardly of the plane of the webs.

The thermoforming may be accomplished in any suitable manner, such as pressure or vacuum forming. In the method shown, the shells are vacuum formed into the desired configurations. For convenient handling, during subsequent processing of the packages, the shells may remain attached to the webs. In the embodiment shown, the shells are formed to semi-spherical configuration with an imperforate nipple 18 extending integrally therefrom, the other shell being formed with a fill spout 20.

The two webs of

plastic

8 and 10 are then converged with the areas surrounding the shells butted together and sealed, as shown at 19. It will now be apparent that upon sealing, the webs include a plurality of containers 22, each container being entirely closed. The fill spout 20, extending upwardly from the container, may be opened or punctured at any time before the filling operation. While as shown, scaling is accomplished by application of heat to the flanges 24, it will be realized that effective sealing may be accomplished in any suitable manner. For example, it has been found that a highly effective seal is obtained by spin welding. In this way only the abutting surfaces of flanges 24 become soft, thus minimizing the possibility of disrupting the plastic.

While in this illustrated embodiment, the container is formed by joining together two half shells, the nurser may be formed as a unitary structure, as will hereinafter be described.

In the method shown in FIG. 1 as the webs are advanced, the containers 22 are moved in sequence to a filling station, shown generally at 23, at which a measured quantity of sterile formula is introduced into the container through the fill spout. After the container is charged with the correct amount of formula, the spout is immediately sealed whereby the container is hermetically sealed. Thereafter, the containers are punched or cut from the webs of plastic. As shown, the containers are out leaving an outwardly extending circumferential flange 24 which enhances the structural rigidity of the nurser and facilitates" its packaging and handling. Of course, the flange provides the means by which the two half shells are sealed together. A suitable seal could, of course, be obtained by other suitable means.

The packaged formula, in hermetically sealed plastic containers 22, may then be deposited on a suitable conveyor, such as shown at 28, by which the containers or nursers are carried to a steam sterilization station which as shown is in the form of an autoclave 30.

After sterilization, the nursers may be placed in a suitable protective package or carrier, such as a bag or box, as shown at 32 in FIG. 2. The entire process described above is carried out under sterile conditions.

While the invention has been described as a continuous manufacturing procedure, it would be equally feasible to produce the nurser-packages as a separate operation, and have them filled, sealed and sterilized as another operation.

structurally, the nurser, shown in FIG. 3, comprises the two

semi-spherical shells

14 and 16. Each shell has a peripheral flange extending radially from its open edge. The flanges are sealed in abutting relation, forming a reinforcement which imparts increased structural rigidity and form stability to the all-plastic-nurser.

In accordance with this invention the shell 16 from which the nipple 18 extends, is substantially more form stable, less flexible, than the other shell 14, although both are formed of flexible synthetic plastic. This construction provides a nurser which is entirely flexible and soft and pleasant to the touch but in which the shell 14 will be collapsed by atmospheric pressure when formula is removed from within the container. Thus, the entire nurser is flexible and unbreakable, but the shell 16 is form stable, that is it Will retain its shape even though all the milk is withdrawn from the container. The relative flexi bility of the

shells

14 and 16 is readily obtainable by providing plastic of different gauge. For example, it has been found that this result is obtained when the plastic web is mil and web 8 is 10 mil polyallomer.

Shell 14 includes a pattern of circumferentially disposed ridges 34 and grooves 36 provided on the shell during forming. This pattern insures complete, unhindered collapse of shell 14. The collapse occurs in steps as milk is withdrawn. Without some provision of this nature, collapse might be so irregular as to prevent complete collapse of the shell 14. Continued sucking under these conditions would defeat the purpose of having a collapsible shell 14 since the infant would swallow a great deal of air. For example, if the shell 14 were not patterned in some way, the nurser might collapse irregularly, such as shown by the broken line at 37 in FIG. 3; with the edge of the concave depression acting as a reinforcement against further collapse of the shell 14. This difiiculty is eliminated by providing means, such as the grooves 36 and ridges 34, for programmed or step-by-step collapse of the shell 14, whereby the rear wall folds inwardly as the liquid is withdrawn.

It is an important aspect of this invention that the nurser be formed of suitable synthetic plastic which can be thermoformed and heat sterilized. Moreover, the material must be air-tight so that the container can be hermetically sealed whereby its contents, once sterilized will remain sterilized until the seal is broken. In addition, the plastic selected must be of sufiicient strength to insure against rupture when filled with liquid and subjected to fairly extensive handling. As suitable material for use in making nursers embodying this invention is polyallomer, which is a crystalline block copolymer of propylene and ethylene. The polyallomer is modified with a suitable elastomer, such as butyl rubber, polyisobutylene, ethylene-propylene terpolymer, ethylene-propylene rubbet. The amount of elastomer used is such that the flexural modulus of the resulting product is less than l.0 10 p.s.i. Polyallomer is the chemical or generic name for these block copolymers, and it is available under the trademark Tenite from Eastman Chemical Company.

When the nurser is to be used it may simply be removed from its package and if desired or required by local regulations, as in the case of hospitals, it may be steam sterilized prior to use. The nurser is readied for immediate use by merely piercing the nipple with a suitable implement, such as a sterile pin. This system avoids the necessity of transferring formula from one vessel to another and of assembling a number of separate nurser components. Similar to natural nursing, moreover, the baby comes into contact only with a soft, pliable nurser with no hard or rigid material harsh to the touch. While this invention provides a nurser which is steam sterilizable, it will be appreciated that sterilization can also be accomplished by irradiation. An important aspect of this invention, however, is that this nurser can if necessary or desirable be steam sterilized.

In FIG. 4 is shown one type of nipple, indicated generally at 38, which can be advantageously formed to extend integrally from the nurser. The nipple comprises a tip 40 and bellows 42 intermediate the shell 16 and the nipple tip 40. The bellows consists of a plurality of circumferentially extending, axially spaced corrugations 44. The bellows section enables the nipple to be freely pivoted and moved without danger of its becoming so crimped that it will impede the flow of fluid.

The bellows portion of the nipple 38 gives the nipple a feel approaching that of a rubber nipple but without the same tendency to collapse completely. The bellows construction also provides a nipple having no sharp corners which are uncomfortable or injurious to the gums of the nursing infant.

Another nipple construction, shown at 46 in FIG. 5, is designed to help the infant hold the nipple. The nipple Comprises an outwardly extending Wall 48 and an end wall 50. The end wall is of substantially greater thickness than the wall 48 so that when the wall 48 is squeezed between the infants gums, the end wall will hold the passage open, as shown by the dotted lines in FIG. 5. The end wall also serves as retaining means, in the nature of a button, holding the nurser against slipping out of the infants month.

In FIG. 6 is diagrammatically shown an alternative method of manufacturing nursers embodying this invention. In this embodiment, a polyallomer plastic sheet of a thickness in the range of .020" to .100" is unwound from a roll 54 and the web of plastic 58 is lead through a heating chamber, as shown at 62. The heater is maintained at a temperature such that the polyallomer web is softened sufficiently for thermoforming in a former 63 including male and female mold portions to provide nurser bodies or shells 64 extending downwardly from the plastic web.

The thermoforming apparatus comprises a combination of female vacuum forming molds 63a and male assist members or plugs 63b with appropriate frames (not shown) for clamping the sheet over each cavity and holding it during forming. This arrangement allows the use of a combination of air pressure and vacuum to effect forming of the flexible nursers. The softened plastic sheet is clamped by the clamping frames and a low bubble is blown in the plastic sheet with its convex side toward the male assist plug which is substantially simultaneously being moved downwardly toward the female mold cavity. The male assist plug forces the soft plastic sheet into the female cavity a predetermined distance. Thereafter vacuum is applied between the sheet and female mold cavity to draw the thermoplastic sheet into the female mold in which it conforms to the final shape of the nurser. Air pressure can be applied simultaneously or in any desired sequence to the inside of the nurser by blowing air through the assist plug. The male assist member engages the central portion of the plastic bubble in approximately the original plane of the underforvmed sheet thereby substantially greater thickness of the sheet material is retained for the deepest dr-aw into the female mold. As a result, there is achieved a differential distribution of thermoplastic sheet material whereby the thicker frontal portion of the nurser, including the nipple, is relatively more form stable than the thinner after portion of the nurser which is sutficiently flexible to collapse upon withdrawal of liquid from the nurser.

It will be realized that the nurser shells are open at the top'but otherwise entirely closed. The next step of the process shown in the provision of a nipple opening. Alternatively the nipple may be left imperforate until ready for use. Perforation of the nipple may be accomplished in any suitable manner and as shown a heated needle or punch 67 and die 68 are cooperatively engaged to penctrate cleanly the plastic nipple to provide a nipple opening for proper valved action of the nurser. After perforation of the nipple the opening is closed and sealed by insertion of a suitable nipple closure 70.

The closure, best shown in FIG. 8, includes a projection 94 which fits snugly and seals the nipple opening. The construction of the closure may be such as will permit the nurser to be filled in the inverted position as shown in FIG. 6.

After the nipple opening has been punched and sealed, the individual nurser shells are cut from the web by a suitable die punch, as shown at 72 in FIG. 6. The nurser shells are then transferred to a suitable conveyor system, such as illustrated at 74 by which they are carried to a filling station 76 at which each receives a measured quantity of nursing formula.

The open end of each nurser shell is then closed and heat sealed and the sealed edges trimmed to provide a neat and trim nurser package.

Following the sealing step the completed nursers are steam sterilized, such as in an autoclave, as shown at 78, for approximately 20 to 30 minutes at 265 F. Following this terminal sterilization, the nursers are cooled and suitably packaged individually and/or in bulk, such as by sealing a predetermined number of nursers in a polyethylene bag.

Shown in greater detail in FIG. 7, is the nurser produced by the method illustrated in FIG. 6. The nurser is integrally thenmoformed of polyallomer with differential material distribution so that the nipple portion 80 is relatively heavier gauge than the lower portion 82. A groove 84 is formed between the frontal, nipple-bearing portion and the after or lower portion, as shown in the drawing, to assist in the assembly of the flexible nurser in a rigid holder or carrier, such as will hereinafter be described, and as shown at 86 in FIG. 8. The material distribution is such that the nipple and areolar or frontal portion 80 of the nurser are flexible and soft but rigid enough to retain their configuration when milk is withdrawn as in nursing. On the other hand, the lower portion 82 being of substantially less thickness, collapses into the form stable frontal portion of the nurser, thereby eliminating the problem of an intake as previously discussed.

In general the nipple and frontal portion of the nurser has a gauge or thickness of around .025-.030 of an inch; gradually this thickness reduces toward the lower portion to a gauge of around .002.0O5 of an inch.

The nipple portion of the nurser includes a tip 89 of generally spherical configuration which blends smoothly into an outwardly extending areolar portion 90 which as shown is conical, but might be any suitable configuration which will serve to extend outwardly the jaws of the nursing infant. In this way, the nursing infant receives substantially the same benefit in oral bone development as the breast fed infant with consequent reduction in dental deformities and orthodontic difficulties so common in todays school age children.

Nursers embodying this invention are made of polyallomer modified with an elastomer, such as uncured butyl rubber, ethylenepropylene terpolymer, ethylenepropylene and the like. The amount of elastomeric material combined with the polyallomer is such that the flexural modulus does not exceed 1.0)(10 p.s.i. In this connection unmodified poly-allomer has a flexural modulus of 1.l3 10 p.s.i. We have found that 40 to 70% by weight uncured butyl rubber may be used to obtain an elastomenmodified polyallomer which is highly flexible, pliable, resilient and soft to the touch approaching the character of rubber, but which can be readily processed and heat sealed. Beyond 70% butyl rubber the mixture becomes so tacky that it is difficult to process. A very suitable combination of materials has been found to be a blend of 50% by 'weight polyallomer and 50% by weight butyl rubber. These materials were thoroughly mixed and milled at 325350 F. and formed into a sheet 0.20" to .100 gauge. Sheets made of this 50/50 blend of polyallomer and butyl rubber were found to have an average flexural modulus of 036x10 p.s.i. The polyallomer used was FDA Approved and designated high impact material #5132DE. By this combination of materials we have provided a nurser-forming material which can be effectively used to manufacture :as a unitary structure, a complete nurser, including the nipple. Moreover, the contents can be easily and effectively sealed within the nursing container. The container can be packaged and sold as a sealed unit, or the nipple perforated as previously described. If sol-d as a wholly sealed unit, the nipple can be readily punctured using a sterile needle or pin.

A sealed polyallomer nurser containing a Similac formula, the concentrate of which was diluted 50% with water, was sterilized at 265 F. for 20-30 minutes. This nurser was then stored under ordinary household conditions, at room temperature for eleven months without any bacterial degradation of the formula.

A most important advantage of the polyallomer-butyl rubber combination in addition to its soft, pliable texture and heat resistant properties, is its low oxygen permeability or transmission. In this regard as compared with natural rubber, which has an oxygen transmission 225 cc./mil/ sq. in./24 hrs/atmospheric pressure differential, a 50/50 blend of polyallomer and uncured butyl rubber was found to have an oxygen transmission of 189 cc./mil/ 100 sq. in./24 hrs/atmospheric pressure differential. This approximate 16% improvement in oxygen permeability is significant since most formulas contain ascorbic acid (Vitamin C) which is unstable in the presence of oxygen. Indeed, it is for this reason that the formula companies have heretofore rejected plastic nursing containers.

If the nipple is perforated, means is provided for sealing the nipple opening, as shown at 70 in FIG. 7. The sealing means shown includes a disc 92 and an outwardly extending projection 94 (FIG. 8). The sealing disc and projection may be integral-1y formed of any material suitable for steam sterilization. Of course, it may be made of the same material as the nurser itself. The projection 94 is configured to fit snugly into the nipple opening to permit filling of the nurser with the nipple end disposed downwardly.

After filling and sterilization as described, the nurser may be bulk packaged in a suitable packaging material or individually packaged in a rigid carrier or container, such as shown in FIGS. 8 and 9. In FIG. 8, the nurser is fitted into an open-ended container or receptacle 96 which may be thermoformed from. sheet stock from .005" to .075" in thickness into any desirable configuration of any suitable synthetic plastic, such as polystyrene, polyethylene, polypropylene, polyvinyl chloride and copolymers or blends therefrom. For example, the receptacle may be cylindrical or polygonal in cross-section.

The receptacle is, of course, dimensioned to receive the lower end of the nurser when it is filled with liquid nursing formula. The upper edge 98 of the bottom container or receptacle is disposed at approximately the same level as the groove. A closure cap or cover, shown generally at 100 is fitted onto the bottom container and sealed around its entire periphery so that the nurser proper is hermetically sealed in a bacteria proof container.

In the embodiment shown the cover comprises a ring element 101 and a separable cap 102. As shown, the nipple closure is carried in the cover cap 100 which is provided with an annular groove 103 which snugly receives the outer edge of the nipple closure disc 92. The ring 101 is bonded, sealed or taped to the bottom container 96; the ring includes an inwardly extending lip 104, the inner edge of which extends into the groove 84 to secure the nurse-r in place in the bottom of the container. The cap extends upwardly from the ring 101 completing the hermetically sealed closure of the nurser. The ring and cap may either be separate components, sealed together, or integrally formed with a score line or weakened section 105 adjacent the lower end of the cap, whereby the cap may be stripped from the ring 101 by simply grasping with the .hand and twisting the cap relative to the ring. The nipple opening may be unsealed by pulling the cap 102 outwardly from the body of the nurser package. In this way the nipple closure 92 may be removed with the cap pulling the projection 94 out of the nipple opening.

An alternate embodiment of carrier is shown in FIG. 9. This comprises a relatively rigid sleeve 106 into which the flexible unitary nurser is fitted. The sleeve has a rim or lip 108 which fits into the groove of the nurser to lock the sleeve in place on the nurser. A nipple protective cap and closure member 110 includes a projection 112 which fits into and seals the nipple opening. The lower end of the cap 110 engages the areolar portion of the nurser so as to fully protect the nipple and surrounding areas which will come into contact with the mouth of a nursing infant.

Having thus disclosed the invention, what is claimed is:

1. Infant feeding device comprising a hermetically sealed container filled with a nursing formula and steam sterilized, said container being formed from an elastomermodified crystalline block copolymer of propylene and ethylene having a fiexural modulus of not greater than 1.0 l -p.s.i., a. nipple and an areolar portion integral with said container, said areolar portion having a circumference substantially greater than the circumference of said nipple and in close proximity to the tip of said nipple to enable the nipple and the areolar portion to be taken into the mouth of said infant, said nipple and said areolar portion being of substantially greater thickness than the remainder of said feeding device so that the remainder collapses upon the withdrawal of the formula from said feeding device.

2. Infant feeding device as set forth in claim 1 in which said elastomer-modified copolymer contains from -70% by weight of uncured butyl rubber.

3. Infant feeding device as set forth in claim 1 in which said elastomer-modified copolymer is comprised of equal parts of the copolymer and uncured butyl rubber and is of integral construction.

4. Infant feeding device comprising a hermetically sealed container filled with a nursing formula and steam sterilized, said container being formed from an elastomcrmodified crystalline block copolymer of propylene and ethylene having a flexural modulus of not greater than 1.0* 10 p.s.i., a nipple and an areolar portion integral with said container and being of substantially greater thickness than the remainder of said feeding device so that the remainder collapses upon withdrawal of the formula from said feeding device.

References Cited UNITED STATES PATENTS 554,071 2/1896 Matzen 215-11 2,446,451 8/1948 Allen 215-11 2,628,906 2/1953 Horan 99--171 2,628,911 2/1953 Horan 99-171 3,112,837 12/1963 Manoyian 215-11 3,117,874 1/1964 Horan 99-171 3,052,559 9/1962 Peebles 99-214 3,289,874 12/1966 Dailey et a1. 99-214 FOREIGN PATENTS 678,359 1/ 1964 Canada. 1,159,591 12/1963 Germany.

2,515 2/1896 Great Britain.

RAYMOND N. JONES, Primary Examiner.

UNITED STATES PATENT OFFICE CERTIFICATE OF CORRECTION July 23, 1968 Patent No. 3,394,018

Stamatis George Velonis et a1.

It is certified that error appears in the above identified patent and that said Letters Patent are hereby corrected as shown below:

line 27, "infant" should read infants line 28, "simpily" should read simplify Column 2, line 11, "This is a continuation-in-part of copending applica-" should read FIG. 4 is a partial view showing one type of nipple Column 6 line 17 "0 26" should read 020" Column 1,

Signed and sealed this 9th day of December 1969.

(SEAL) Attest:

WILLIAM E. SCHUYLER, JR.

Edward M. Fletcher, Jr.

Commissioner of Patents Attesting Officer