Biodegradable water soluble tampon applicator and process and apparatus to manufacture same

Abstract

A substantially biodegradable and water soluble tampon applicator comprising: a plunger and a barrel, said plunger being of a predetermined length, and having a first end and a second end, said second end being a predetermined distance from said first end, said plunger being substantially cylindrical in shape and having a first diameter at said first end and a second diameter at said second end, wherein said first diameter tapers downwards to said second diameter, proximate said first end, said plunger further comprises a first mating portion, said barrel having a first end and a second end, said second end being a predetermined distance from said first end, said barrel being substantially cylindrical in shape and having a diameter greater than the first diameter of said plunger, proximate said first end of said barrel, there is provided a second mating portion to matingly engage said first mating portion of said plunger to maintain said plunger in relation to said barrel in a first position, proximate said first end of said barrel, adjacent said second mating portion, said barrel further comprises a fingergrip.

Claims

1. A process of manufacturing a biodegradable and water soluble tampon applicator using film forming technology, said process comprising: i) dipping a plunger pin for the formation of a plunger of a tampon applicator and a barrel pin for the formation of a barrel of a tampon applicator in a composition, said composition comprising: a) at least one cellulose-based film forming compound selected from the group consisting of cellulose ether, and hydroxypropylmethyl cellulose; b) a hydrocolloid and c) at least one compound selected from the group consisting of sequestering agent, starch, pullulan, and polyvinyl alcohol; for a period of time to allow said composition to form a film on each of said plunger pin and said barrel pin; ii) allowing said film to dry to a desired moisture level and a desired film thickness; and iii) stripping said dried film from each of said plunger pin and barrel pin; said dried film formed by said plunger pin forming a plunger of said tampon applicator, said dried film formed by said barrel pin forming a barrel of said tampon applicator wherein said plunger moveably fits within said barrel forming a tampon applicator, said barrel for holding a tampon wherein said sequestering agent is for water hardness removal and is selected from the group consisting of ethylenediaminetetraacetic acid, acetic acid, boric acid, citric acid, gluconic acid, lactic acid, phosphoric acid, tartaric acid or salts thereof methaphosphates, dihydroxyethylglycine, lecithin or beta cyclodextrin and combinations thereof.

2. The process of claim 1, wherein said composition further comprises at least one additive to assist in the film forming process, a plasticizer, a gelatinizing agent, carrageenan, and gellan gum.

3. The process of claim 1, wherein said composition comprises from about 90 to about 99.98% by weight of a cellulose ether or mixture of cellulose ethers with water content of about 2 to about 10% by weight, from about 0.01 to about 5% by weight of a hydrocolloid or mixtures of hydrocolloids, and from about 0.01 to about 5% by weight of a sequestering agent or agents.

4. The process of claim 1, wherein said composition comprises from about 5 to about 25 parts by weight of a water-soluble cellulose derivative, from about 0.1 to about 0.5 parts by weight of a gelatinizing agent and from about 0.01 to about 0.5 parts by weight of an auxiliary for gelation of said gelatinizing agent, wherein said auxiliary for gelation is for assisting gelling of said gelatinizing agent at room temperature, said auxiliary for gelation of said gelatinizing agent being selected from the group consisting of a water soluble compound containing potassium ion, ammonium ion or calcium ion.

5. The process of claim 4, wherein said desired moisture level is 3-7% by weight.

6. The process of claim 4, wherein said desired film thickness is from about 1.5 to 3 millimeters.

7. The process of claim 4, wherein each of said plunger pin and barrel pin are lubricated with a lubricant prior to dipping into said composition.

8. The process of claim 7, wherein said lubricant is selected from the group consisting of lecithin & lecithin/mineral oil.

9. The process of claim 4, wherein said period of time for dipping said plunger pin and said barrel pin is between 30-60 minutes.

10. The process of claim 4, wherein once said plunger pin and said barrel pin have been dipped, each of said dipped pins are rotated 360 degrees in a circular manner for even distribution of said film on each of said plunger pin and barrel pin.

11. A process of manufacturing a biodegradable and water soluble tampon applicator using film forming technology, said process comprising: i) dipping a plunger pin for the formation of a plunger of a tampon applicator and a barrel pin for the formation of a barrel of a tampon applicator in a composition, said composition selected from at least one of the following: a. i) at least one cellulose-based film forming compound selected from the group consisting of cellulose ether, and hydroxypropylmethyl cellulose; ii) a hydrocolloid and iii) at least one compound selected from a sequestering agent, starch, pullulan, and polyvinyl alcohol; b. from about 90 to about 99.98% by weight of a cellulose ether or mixture of cellulose ethers with water content of about 2 to about 10% by weight, from about 0.01 to about 5% by weight of a hydrocolloid or mixtures of hydrocolloids, and from about 0.01 to about 5% by weight of a sequestering agent or agents; c. from about 5 to about 25 parts by weight of a water-soluble cellulose derivative, from about 0.1 to about 0.5 parts by weight of a gelatinizing agent and from about 0.01 to about 0.5 parts by weight of an auxiliary for gelation; for a period of time to allow said composition to form a film on each of said plunger pin and said barrel pin; ii) allowing said film to dry to a moisture level of 3-7% by weight and a film thickness of from about 1.5 to 3 millimeters; and iii) stripping said dried film from each of said plunger pin and barrel pin; said dried film formed by said plunger pin forming a plunger of said tampon applicator, said dried film formed by said barrel pin forming a barrel of said tampon applicator wherein said plunger moveably fits within said barrel forming a tampon applicator, said barrel for holding a tampon wherein said sequestering agent is for water hardness removal and is selected from the group consisting of ethylenediaminetetraacetic acid, acetic acid, boric acid, citric acid, gluconic acid, lactic acid, phosphoric acid, tartaric acid or salts thereof methaphosphates, dihydroxyethylglycine, lecithin or beta cyclodextrin and combinations thereof and wherein said auxiliary for gelation is for assisting gelling of said gelatinizing agent at room temperature, said auxiliary for gelation of said gelatinizing agent being selected from the group consisting of a water soluble compound containing potassium ion, ammonium ion or calcium ion.

12. The process of claim 11, wherein each of said plunger pin and barrel pin are lubricated with a lubricant prior to dipping into said composition.

13. The process of claim 12, wherein said lubricant is selected from the group consisting of lecithin & lecithin/mineral oil.

14. The process of claim 11, wherein said period of time for dipping said plunger pin and said barrel pin is between 30-60 minutes.

15. The process of claim 11, wherein once said plunger pin and said barrel pin have been dipped, each of said dipped pins are rotated 360 degrees in a circular manner for even distribution of said film on each of said plunger pin and barrel pin.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) The following figures illustrate preferred and alternative embodiments of the invention, wherein:

(2) FIG. 1 is a side view of a preferred embodiment of the pin for the plunger element of the tampon applicator according to the present invention.

(3) FIG. 2 is a side view of a preferred embodiment of the pin for the barrel element of the tampon applicator according to the present applicator.

(4) FIG. 3 is a side view of the plunger formed by the pin of FIG. 1 according to the present invention.

(5) FIG. 4 is a side view of the barrel formed by the pin of FIG. 2 according to the present invention.

(6) FIG. 5A is a side view of a barrel of the tampon applicator of FIGS. 3 and 4, according to the present invention.

(7) FIG. 5B is a side view of a plunger of the tampon applicator of FIGS. 3 and 4, according to the present invention.

(8) FIG. 5C is a side view of a barrel and plunger of the tampon applicator of FIGS. 3 and 4 in a first position, according to the present invention.

(9) FIG. 5D is a side section view of a barrel and plunger of the tampon applicator of FIGS. 3 and 4 in a first position, according to the present invention.

(10) FIG. 5E is a side view of a barrel and plunger of the tampon applicator of FIGS. 3 and 4 in a second position, according to the present invention.

(11) FIG. 5F is a perspective view of the tampon applicator of FIGS. 3 and 4, according to the present invention.

(12) FIG. 6A is a side view of a barrel of a tampon applicator in another embodiment of the present invention, according to the present invention.

(13) FIG. 6B is a side view of a plunger of a tampon applicator in another embodiment of the present invention, according to the present invention.

(14) FIG. 6C is a side view of a barrel and plunger of a tampon applicator in another embodiment of the present invention, according to the present invention.

(15) FIG. 6D is a side section view of a barrel and plunger of a tampon applicator in another embodiment of the present invention in a first position, according to the present invention.

(16) FIG. 6E is a side view of a barrel and plunger of a tampon applicator in another embodiment of the present invention in a second position, according to the present invention.

(17) FIG. 6F is a perspective view of a tampon applicator in another embodiment of the present invention, according to the present invention.

(18) FIG. 7A is a side view of a barrel of a tampon applicator in another embodiment of the present invention, according to the present invention.

(19) FIG. 7B is a side view of a plunger of a tampon applicator in another embodiment of the present invention, according to the present invention.

(20) FIG. 7C is a side view of a barrel and plunger of a tampon applicator in another embodiment of the present invention, according to the present invention.

(21) FIG. 7D is a side section view of a barrel and plunger of a tampon applicator in another embodiment of the present invention in a first position, according to the present invention.

(22) FIG. 7E a side view of a barrel and plunger of a tampon applicator in another embodiment of the present invention in a second position, according to the present invention.

(23) FIG. 7F is a perspective view of a tampon applicator in another embodiment of the present invention, according to the present invention.

(24) FIG. 8A is a side view of a barrel of a tampon applicator in another embodiment of the present invention, according to the present invention.

(25) FIG. 8B is a side view of a plunger of a tampon applicator in another embodiment of the present invention, according to the present invention.

(26) FIG. 8C is a side view of a barrel and plunger of a tampon applicator in another embodiment of the present invention, according to the present invention.

(27) FIG. 8D is a side section view of a barrel and plunger of a tampon applicator in another embodiment of the present invention in a first position, according to the present invention.

(28) FIG. 8E a side view of a barrel and plunger of a tampon applicator in another embodiment of the present invention in a second position, according to the present invention.

(29) FIG. 8F is a perspective view of a tampon applicator in another embodiment of the present invention, according to the present invention.

(30) FIG. 9A is a side view of a barrel of a tampon applicator in another embodiment of the present invention, according to the present invention.

(31) FIG. 9B is a side view of a plunger of a tampon applicator in another embodiment of the present invention, according to the present invention.

(32) FIG. 9C is a side view of a barrel and plunger of a tampon applicator in another embodiment of the present invention, according to the present invention.

(33) FIG. 9D is a side detail view of the mating of a barrel and plunger of a tampon applicator in another embodiment of the present invention, according to the present invention.

(34) FIG. 9E is a side view of a mating member of a plunger of a tampon applicator in another embodiment of the present invention, according to the present invention.

(35) FIG. 9F is a cross-sectional view of a mating member of a barrel of a tampon applicator in another embodiment of the present invention, according to the present invention.

(36) FIG. 10A is a side view of a barrel of a tampon applicator in another embodiment of the present invention, according to the present invention.

(37) FIG. 10B is a side view of a plunger of a tampon applicator in another embodiment of the present invention, according to the present invention.

(38) FIG. 10C is a side view of a barrel and plunger of a tampon applicator in another embodiment of the present invention, according to the present invention.

(39) FIG. 10D is a side detail view of the mating of a barrel and plunger of a tampon applicator in another embodiment of the present invention, according to the present invention.

(40) FIG. 10E is a cross-sectional view of a mating member of a barrel of a tampon applicator in another embodiment of the present invention, according to the present invention.

DETAILED DESCRIPTION OF THE INVENTION

(41) Referring now to FIGS. 1, 2, 3 and 4, the plunger pin 10, has a locking ring 20 near the dome 30 as an indentation. The locking ring 20, is preferably strong enough to hold the plunger 50 inside the barrel 60, and to allow the consumer to push the plunger 50 into the barrel 60 thus allowing the cotton tampon or pledget (not shown) to be pushed through the barrel 60 and into the vaginal vault.

(42) The plunger pin 10 is slightly tapered from the dome 30 (smaller diameter) to the end 40 away from the dome (larger diameter). This taper is meant to ensure a snug fit of the plunger 50 into the barrel 60 and prevent the plunger 50 from being pushed through the barrel 60. This will prevent issues on insertion and it will prevent the plunger 50 from entering the vaginal vault.

(43) The barrel pin 80 of the tampon applicator has several features:

(44) The barrel pin locking ring 90 appears near the end of the barrel farthest away from the barrel pin dome 100. In order to create the barrel pin locking ring 90, a V or U shaped indentation is designed to create a ring around the entire barrel 60 when the barrel pin 80 is dipped in the molten raw materials chosen based on the desired composition.

(45) In order to create the finger-tip grip 110 the barrel pin 80 flares out, preferably at a 20 degree angle then flatten back out towards the end 120 opposite the dome end 100. This creates an outward flange that will serve as the finger tip grip 110. The barrel pin 80 further comprises an indicium 320 located thereon. The indicium 320 is either depressed or raised along the body thereof. Similarly, the plunger pin 10 may also have an indicium situated thereon (not shown). If both the barrel pin 80 and plunger pin 10 each have an indicium thereon, the resulting indicium on the barrel 60 and plunger 80 will act not only as an indicium for marketing message, logo, health message or the like, but also as a locking mechanism to prevent the plunger 80 from entering the vaginal vault.

(46) The following is a detailed description of a preferred embodiment of the barrel and plunger of the tampon applicator.

(47) Barrel & Plunger Assembly, referring now to FIGS. 5A-5F,

(48) The tampon applicator 300 comprises a plunger 301 and a barrel 302. Said plunger 301 and barrel 302 being made of a material that is substantially biodegradable and substantially water soluble. Said plunger 301 being of a predetermined length, and having a first end 340 and a second end 350. Said second end 350 being a predetermined distance from said first end 340. Said plunger 301 being substantially cylindrical in shape and having a first diameter 341 at said first end 340 and a second diameter 351 at said second end 350, wherein said first diameter 341 tapers downwards to said second diameter 351. Said plunger 301 being hollow from said first end 340 to said second end 350, thus having a first opening 342 and a second opening 352. Proximate said first end 340, said plunger 301 further comprises a first mating portion 360, preferably in the shape of an indentation ring. Proximate the first end 340 and adjacent said first mating portion 360, said first opening 342 of said plunger 301 is formed as a truncated dome 370.

(49) Said barrel 302 having a first end 380 and a second end 390. Said second end 390 being at a predetermined distance from said first end 380. Said barrel 302 being substantially cylindrical in shape and having a diameter greater than the first diameter 341 of said plunger 301, to allow for a substantially snug fit of the plunger 301 into said barrel 302 whilst preventing the plunger 301 from extending beyond the second end 390 of said barrel 302 and entering the vaginal vault.

(50) In a preferred embodiment, the barrel 302 is hollow from said first end 380 to said second end 390. Said barrel 302 is hollow to allow a pledget to be inserted therein. Proximate said first end 380 of said barrel 302, there is provided a second mating portion 330 in the shape of a locking ring, to matingly engage said first mating portion 360 of said plunger 301 to maintain said plunger 301 in relation to said barrel 302 in a first position (see FIG. 5C), and to prevent the plunger 301 from separating from said barrel 302 during packaging, handling and shipping. Proximate said first end 380 of said barrel 302, adjacent said second mating portion 330, said barrel 302 further comprises a fingergrip area 310 to assist in gripping the barrel 302 of the tampon applicator 300 whilst pushing the plunger 301 into the barrel 302 causing the tampon or pledget to be inserted into the vaginal vault. The fingergrip area 310 is substantially flange like.

(51) In a preferred embodiment, said tampon applicator further comprises at least one indicium 320. Preferable said at least one indicium 320 comprises a marketing message or logo or the like. Preferably said at least one indicium 320 is formed during the film forming process of said barrel 302 or plunger 301. Referring now to FIG. 3, the plunger is shown with an indicium 320 thereon. Referring now to FIG. 4, the barrel is shown with an indicium 320 thereon. When the indentation ring 360 of the plunger 301 is inserted into the barrel 302, it will slide until it locks within the V or U groove of the barrel locking ring 330. When the rings of both the barrel and plunger are aligned correctly, there will be a snug fit and the barrel and plunger will be secured to each other in a first position (see FIG. 5D). The rings 330 and 360 act to hold the plunger and barrel together, for shipping and transportation. However, once in the hands of a consumer, pressure exerted on the end 350 of the plunger 301, the consumer will be able to push the plunger 301 into the barrel 302 to extract the cotton tampon or pledget into the vaginal vault (see FIG. 5E).

(52) Other embodiments of the barrel and plunger configuration are depicted in FIGS. 6A-10E.

(53) In one embodiment illustrated in FIGS. 6A-6F, the rim 440 of the plunger 401 is tapered outwardly having a diameter 443 greater than the diameter 441. In this embodiment the barrel 402 has an embossed ring 432 bordered by indented rings 431 and 433 at the mating area 430. This way there is no need to create an embossed ring on the plunger 401 since its mating function is fulfilled by the means of the rim 440 with diameter 443. Preferably, during the manufacturing process of the tampon applicator 400, the plunger 401 is inserted into the barrel 402 from the end 490 while the end 450 is inserted first till the rim 440 locks into the ring 432 (see FIGS. 6C and 6D). This assists in retrieval of the tampon applicator 400 from the vaginal chamber following the insertion of the tampon by pulling the assembly by the end 450 while avoiding the possibility of leaving the barrel 402 inside the vaginal chamber.

(54) In another embodiment illustrated in FIGS. 7A-7F, the first end 590 of the barrel 502 has a number of petals 591 separated by cuts 592. Petals 591 facilitate the insertion of the tampon applicator 500 into the vaginal chamber as well as assisting in the delivery of the tampon or pledget. The pressure of the plunger 501 on the tampon (not illustrated) causes opening of the petals and release of the tampon into the chamber. In this embodiment the plunger 501 comprises a depressed ring 560 to mate with a depressed ring 530 of the barrel 502 to maintain the tampon applicator 500 together during shipping (see FIG. 7C). In this embodiment the diameter 551 is greater than the diameter 541 and smaller than the diameter 531, to prevent extension of the plunger 501 from the end 590 of the barrel 502 (see FIG. 7E).

(55) Indicium 520 shown on barrel 502 is raised. Similarly, indicium 521 shown on plunger 501 is raised (see FIG. 7C depicting the plunger and a barrel from the side view). In this embodiment, the indicia 520 and 521 when the plunger 501 is inserted into the barrel 502, will matingly engage with each other to further act as a locking mechanism to prevent extension of the plunger 501 from entering the vaginal vault, once the tampon has been inserted (see FIG. 7E). In this instance, indicium 520 will be slightly larger than indicium 521 to allow for matingly engagement.

(56) The barrel and the plunger each may have more than one indicium, either substantially identical to each other, matingly completing each other, such that one indicium matingly engages with the other indicium, or having an aesthetical feature.

(57) In yet another embodiment illustrated in FIGS. 8A-8F, the barrel 602 has a tapered end 690 equipped with substantially flexible petals 631 facilitating insertion of the tampon applicator 600 into the vaginal chamber. The number of petals may vary, but preferably may be 3, 4 or more, depending on the manufacturing preferences and material selection. Further in this embodiment the second end 650 of the plunger 601 is closed and dome-shaped thus creating an air pressure in addition to a mechanical pressure during the extraction of the tampon from the barrel 602 into the vagina chamber. Further in this embodiment the diameter 651 at the end 650 is smaller than the diameter 641 at the end 640.

(58) In still another embodiment illustrated in FIGS. 9A-9F, the mating member 760 of the plunger 701 is raised and not depressed (see FIG. 9E). Thus the diameter 760 is larger than the diameter 741 while smaller than the diameter 751. Further, the mating member 730 of the barrel 702, in this embodiment, is a plurality of recesses 731, best illustrated in FIG. 9F. The mating of the plunger 701 and the barrel 702 is best illustrated in FIG. 9D. The number of recesses may vary but preferably can be 2, 3, 4 or more and the form of those recesses 731 can be rounded, triangular or irregular as per manufacturing preferences.

(59) The embodiment illustrated in FIGS. 10A-10E is similar to the one at FIGS. 9A-9F, the main difference is that the mating member 830 of the barrel 802 grips the outer wall of the plunger 801 (see FIG. 10D) with recesses 831.

(60) All the features illustrated in the provided figures are exemplary and can be interchanged between the embodiments without departing from the scope of the invention. For example the embodiments in FIGS. 9A-9F and 10A-10E may have same leaflets as in FIGS. 8A-8F and so on.

(61) Dissolution Study.

(62) The following is a detailed description of a preferred embodiment of the tampon applicator undergoing a dissolution study.

(63) Two different methods were used to determine disintegration:

(64) 1. Using a USP DT (Disintegration Test) Apparatus at 25 C The DT apparatus consists of a basket, rack assembly and a mechanical device to move it up and down. A rigid basket-rack assembly supporting three cylindrical glass tubes about 106 mm long, about 32.5 mm in internal diameter and about 3 mm thick, attached to a mechanical device, which in turn raised and lowered the basket smoothly at a constant frequency of between 28 and 32 cycles per minute through a distance of 50 to 60 mm. The tampon applicator was inserted in to the basket and the dissolution test was conducted. Results are depicted below.

(65) 2. Disintegration Test Using Magnetic Stirrer Method This test incorporated a 100 ml glass beaker, magnetic stirrer and magnetic stirrer unit, thermometer, stopwatch, tampon applicator and distilled water. 800 ml of distilled water was placed in the beaker and the temperature of the water was maintained at 25+/1 C. The magnetic stirrer was placed in the beaker. The magnetic stirrer unit was turned on and the speed was set in order to have a water vortex of 25+/5 mm (1+/). The tampon applicator was placed in the beaker and simultaneously the stopwatch was switched on until 90% of the tampon applicator was dissolved. Thereupon the stopwatch was switched off. On average, 90% of the tampon applicator was dissolved between about 38 to about 43 minutes. The remaining 10% dissolved within about 120 minutes from initiating each study.
Comparison of DT Time

(66) TABLE-US-00001 DT time (minutes:seconds) Sample No. Magnetic stirrer method USP apparatus 1 46:18 37:41 2 50:14 38:33 3 43:42 38:55 Average 46:44 38:23

(67) The following is a detailed description of a preferred embodiment of the dipping process used to manufacture the tampon applicator of the present invention.

(68) The stainless steel pins are dipped into the solution and slowly withdrawn to ensure an even distribution of the raw material. The depth of the dip will be in the range of 4-6 mm from the eventual cut line of the applicator.

(69) The pins are then flipped 360 degrees in a circular manner to further ensure even distribution of the film.

(70) With the dome of the pins facing upwards, the pins will now go through a drying phase where the removal of moisture from the film is enhanced by the addition of warm dry air.

(71) The timing of this process is in the range of about 30-60 minutes and the moisture level in the film is in the range of 3-7%.

(72) While the foregoing provides a detailed description of a preferred embodiment of the invention, it is to be understood that this description is illustrative only of the principles of the invention and not limitative. Furthermore, as many changes can be made to the invention without departing from the scope of the invention, it is intended that all material contained herein be interpreted as illustrative of the invention and not in a limiting sense.