CA1040351A - Inserter for delivering soft, deformable tampons into body cavities and the combination of a tampon therewith - Google Patents

Abstract

ABSTRACT OF THE DISCLOSURE

The specification describes an inserter for delivering soft, deformable tampons into body cavities and the combination of the inserter with a suitable tampon. The inserter is made up of a pair of telescoping elements. The outer element is in the form of a tube. The inner element may also be in the form of a tube and has a main portion slidably disposed within the outer tube and a front portion comprising a smaller diameter frontal extension axially disposed on the forward end of the main portion and having a length substantially as long as the outer element when the inner element is slidably disposed therein. In the inserter and tampon combination, the tampon is made from single or multiple sheets of resiliently deform-able material in various shapes. The resilient tampon is disposed within the outer tube to provide a forward head portion and a trailing drape-like portion with at least the trailing portion being deformed and held in releasable compres-sion between the frontal extension and the outer tube. In this arrangement, the leading end of the frontal extension bears against the inside of the head portion of the tampon and when the inner element is advanced inside the outer tube to deposit the tampon in the vagina, the head portion of the tampon is urged from the outer tube while the trailing portion is drawn from the outer tube. Upon ejection the resiliently deformable nature of material from which the tampon is made permits the tampon to expand as far as the restrictive walls of the cavity permit and thus generally conform to the irregular shape of the cavity.

Description

It is known that absorbent tampons made of soft deformable materials, and particularly resiliently deformable materials, such as hydrophilic or mensesphilic polyurethane foams, provide high absorbent capacity for menstrual exudate and tend to minimize early leakage.
This is attributed in part to the fact that relatively uncompressed low density materials are in their most effective absorbent state from the start and do not have to be acted upon, or depend on other expansion activating agents, to expand to useful size. In addition, soft uncompressed low density materials have surface areas which more readily accept exudate and have a faster uptake than do the hardened surface areas of conventional compressed tampons. Further when resilient materials such as foams are used, the inherent springy resiliency such foams possess enable these foams to conform more readily to the multiple irregular folds, ridges and valleys of the vaginal walls when the walls are in their normal collapsed state. While high pressures exerted by the walls on any particular portion of the foam will tend to compress the foam considerably in the particular area where such pressure is exerted, immediately adjacent wall areas which exert lesser pressure, compress the foam correspondingly less, and the foam, in trying to expand to its normal uncompressed condition, will tend to fill any voids which exist thus reducing the possibility of side channel leakage and premature failure.
The main problem in utilizing resiliently deformable or other soft low density materials for internal catamenial use is how to conveniently deliver , ~ ., . : . . , . : .

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the ma~erial into the vaginal vault in a manner which overcomes the high pressures that ordinarily resist the introduction of such soft resilient material into the vaginal channel.
Such material has no significant columnar strength or integrity even when compressively confined in a tube. Accordingly, when attempts were made to use conventional delivery systems comprising a pair of telescoping tubes in which the tampon is compressively disposed in an outer tube, and an inner tube or similar pusher element is utilized to push against the bottom of the tampon to eject it into the vaginal cavity, it was found that during ejection the tampons tended to collapse or compress longitudinally, spread laterally and cause jamming within the tube so delivery was quite difficult or impossible. As a result when using ordinary tube systems one had to resort to compressing the material beyond its elastic limit or otherwise structure it in a manner to make the tampon material sufficiently dense or stiff to provide it with enough temporary structural integrity or columnar strength to be self-supporting and thus capable of being shoved out of the tube from below without the above-mentioned di f f i culties.
Thus, while the desirability of using a tampon which exhibl~s softness and resiliently expandable capa-bilities immediately upon insertion has been recognized, a means for delivering a tampon with such capabilities in the desired substantially uncompressed condition and in an economically feasible manner has not been satis-factorily achieved prior to this invention. Some inserterdevices have been developed which mechanically spread .

, . - . , ~0~0351 deformable tampons at the time of insertion but none have been developed which satisfactorily hold a tampon of resiliently deformable material in temporarily deformed condition; which are capable of delivering the tampon with acceptable ease while in relatively uncompressed condition; and when resiliently compressible material is used, utilize the inherent resiliency of the tampon itself to permit spontaneous expansion after delivery without the need for mechanically assisted deployment or for activation by the subsequent absorption of the fluids the tampons are designed to capture.
This invention is directed to a delivery system which is substantially independent of the density, soft-, ness, structural integrity or columnar strength of the tampon and yet permits relatively easy insertion of soft, ' readily deformable low density tampons, which may or may not be resilient, into the vaginal cavity in spite of the high pressure resistance of the walls which is normally encountered. In addition, it permits lateral positioning of the tampon after expulsion from thetemporarily confining carrier member of the system.
The invention is also directed to the combina-tion of the described delivery system with particularly suitable tampons as further defined herein.
SUMMARY OF THE INVENTION
The delivery system of this invention utilizes what at first glance appears to be a conventional pair of telescoping members to achieve delivery of tampons into the vagina while the tampons are in soft, deformable condition. That is, the delivery system comprises a pair , .

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~ -4 ~0403Sl of telescoping elements in which the outer element is in the form of a tampon-confining tube or sheath and the inner element has a main tubular portion slidably disposed within the outer tube. The structure differs from the prior art in that the inner element is addi-tionally provided with a centrally disposed frontal extension of smaller diameter than the main tubular portion. This frontal extension is dimensioned to extend through at least a major part of the length of the outer tube when the main tubular portion of the inner element is positioned therein. When combined with a tampon, the leading end of the frontal extension acts as a bearing member for the inside of the head portion of a deformable tampon, as the tampon is disposed within the outer tube, and serves to draw the remaining trailing portion of the tampon out of the tube during ejection.
In assembling the tampon and delivery system, the leading end of the frontal extension which bears against the inside of the tampon is applied to the approximate mid-point of the lower surface of an unstressed tampon and while thus positioned is pushed into the outer tube until the entire tampon is disposed inside the outer tube. When thus assembled, the head of the tampon resting on the frontal extension is compressed in thickness at its point of support and the remaining trailing portion of the tampon is circum-ferentially disposed around the frontal extension and -resiliently compressed between the frontal extension of the inner element and the inner wall of the outer tube.

.

~0403Sl When put to its intended use, the outer tube containing the tampon is first inserted into the vaginal cavity to the desired depth. The user then presses against the rear end of the inner element to slide it forward into the outer tube and eject the tampon into the vaginal cavity. During ejection the deformable tampon is worked as it slides through the confining member, loosening any temporary compression set which may have developed due to long term storage or high temperature sterilizing and the tampon then attempts to regain its original uncompressed form. The restrictive nature of the collapsed walls of vaginal cavity in their natural state will not permit the tampon to expand all the way, of course, but because the material is soft and easily deformable, the tampon will always try to expand and fill up areas where it is not restricted and thus tend to conform to most of the multiplicity of irregular shapes and configurations which the walls naturally possess. Further, as these shapes and configurations change during normal body movements, the deformable nature of the tampon permits the configuration of the tampon to give and take with these body movements and thus continue to conform to the shape of the vagina without the discomfort sometimes associated with highly compressed tampons.
At the time of ejection from the outer tube and into the vagina, the inside of the head portion of the tampon initially remains in contact with the leading end of the frontal extension of the inner element. This permits the user to employ the inserter to move the tampon .. : . . . . ~
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laterally within tne vagina to a limited extent for more comfortable positioning if desired before withdrawing the inserter device. Such after-ejection positioning is not possible with conventional tube type inserters since when the latter inserters are used the inner element loses all positive contact with the tampon once the tampon is ejected.
The delivery members are preferably made of a smooth flexible plastic such as low to high density polypropylene or polythylene although other suitable materials including other plastic and paperboard may be used. The front of the outer tube may either be open or have a substantially closed configuration comprised of adjoining flexible petal shaped elements as are known in the art, and which flex open as the tampon is expelled.
The tampon may be made of any soft, deformable material, but is preferably made of sheets or strips of hydrophilic and mensesphilic polyurethane foams, many ' 20 of which are known in the art. The tampon also may have innumerable shapes and configurations. The important characteristic is that the selected shape be sufficiently deformable so that when the central portion of the tampon `~ is rested on the leading end of the frontal extension of ., the inner element it can be temporarily confined within the outer tube as described above. It is also preferred ; that when strips or sheets of foam are used, the sheets or strips be wrapped with a fluid pervious web of woven or non-woven construction. Preferably such wrapping is effected in a manner to permit the absorbent material to . .;
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~ ' ,~, 10403~;1 expand without restriction when wetted. Non-woven webs are usually more economical and are therefore preferred.
Such wrappers add tensile strength to relatively weak foams, and in addition, they reduce the amount of friction which would otherwise be generated between the foam surface and the inner wall of the delivery tube if the wrapper were not present. The wrapper may be hydrophilic or hydrophobic.
When tampon and inserter are assembled, the tampon may be totally enclosed within the outer tube or alternatively, may have a portion partially extending out of the front end. In the latter case the exposed head portion acts as a swab during insertion, and provides added assurance against the possibility of early leakage.
Other embodiments and advantages of the invention will become apparent by reference to the accompanying drawings and detailed description.
BRIEF DESCRIPTION OF THE DRAWINGS
In the drawings:
FIG. 1 is a side view of one embodiment of the inserter device of this invention with portions of the outer element partially cut away.
FIG. 2 is a side view of the FIG. 1 inserter device with a deformable tampon contained therein.
FIG. 3 is a longitudinal section taken along line 3--3 of FIG. 2.
FIG. 4 is a longitudinal section similar to FIG. 3 showing another embodiment of the invention.

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FIG. 5 is another longitudinal section showing a modified version of the inner element for the inserter device.
FIG. 6 is a side view similar to FIG. 2 but showing a partially reexpanded tampon as it may appear in idealized form when it begins to expand after full ejection from the inserter.
FIG. 7 is a plan view of an embodiment of another form of tampon suitable for use with this invention.
FIG. 8 is a section taken along line 8--8 of FIG. 7.
FIG. 9 is a section similar to FIG. 8 but showing another strip construction.
FIG. 10 is a side view partially cut away of the FIG. 7 tampon in association with the inserter elements defined herein, and illustrating the first step in assembling the tampon and inserter device.
FIG. 11 is a side view similar to FIG. 10 showing the tampon partially introduced into the outer tubular member of the inserter device.
FIG. 12 is a side view of the FIG. 7 tampon fully disposed within the inserter device.
FIG. 13 is a longitudinal section of FIG. 12.
FIGS. 14-16 are several views of another embodiment of a tampon suitable for use in this invention.
FIGS. 17-19 are several views of still another tampon in accordance with this invention.

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FIG. 20 is a side view of an embodiment of a spheroidal loop tampon suitable for use in this invention.
FIG. 21 is a top plan view of the tampon -of FIG. 20.
FIG. 22 is a top plan view of the tampon of FIGS. 20 and 21 showing how it appears with the spheroid flattened preparatory to introducing the tampon into the outer delivery tube of the inserter device defined herein~
FIG. 23 is a side view partially cut away of the flattened tampon of FIG. 22 in association with the inserter elements showing the first step in com-bining the tampon with an inserter device.
FIG. 24 is a partial side view showing the FIG. 22 tampon partially introduced into the outer delivery tube of the inserter device.

DETAILED DESCRIPTION OF THE DRAWINGS AND PREFERRED
EMBODIMENTS OF THE INVENTION
.
In FIG. 1 of the drawings there is shown a preferred embodiment of the inserter device of this invention. As shown therein the inserter is comprised of a set of telescoping elements. The outer element 12 ;
. .
is in the form of an open-ended tube which may have a flange 13 at its rear end to provide finger grasping means. The inner element is comprised of a main portion 14 which is in slidable engagement with the inner wall of outer element 12. Main portion 14 is of tubular configuration and has a stop flange 15 at its rear end, and has at its forward end an axially disposed frontal extension 16 of smaller diameter than main portion 14.
The leading end 17 of frontal extension 16 as shown in this figure extends beyond the leading end of outer . .. ; - , ., -' :' , ' ` , ~04~
element 12. The length of the frontal extension can, of course, be adjusted to meet any selected design requirements. It should, however, be substantially as long as the outer tube when positioned therein in order to achieve complete ejection of the tampon when the inner element is advanced to its full stop position.
In FIGS. 2 and 3, the inserter device of FIG. 1 is shown in combination with a resiliently deformable tampon 20. In assembling this combination, a substan-tially flat tampon 20 of resiliently deformable materialsuch as thin polyurethane sponge is draped over leading end 17 of frontal extension 16 of the inner element and while supported thereon is pushed through the rear end of outer element 12. This action radially compresses tampon 20 as it is confined in the restricted narrow space 21 circumferentially defined between frontal extension 16 and the inner wall of outer tube element 12. As the tampon is pushed further into outer tube element 12 so that the head portion of tampon 20 partially protrudes from the leading end of outer tube element 12, the protruding head portion of the tampon tends to reexpand due to its inherent resilience as it escapes the confining influence of outer element 12.
The remaining trailing portion of the tampon remains compressed as it is still confined in the circumferential space between frontal extension 16 and outer element 12.
When a tampon-inserter assembly of the type shown in FIGS. 2 and 3 is inserted in the vaginal cavity, the partially expanded tampon serves to swab clean any menstrual fluid which may have been left on the lower vaginal areas after the previously used tampon was removed.

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In FIG. 6, the FIG. 2 combination is shown in idealized form to depict how the tampon 20 tends to spread out after it is fully ejected from tube 12 and begins to reexpand when removed from the restrictive confines of outer tube 12. The tampon as shown here is one which is initially circular in shape and resembles a partially opened umbrella as it begins to open. A
variety of other shapes and styles of tampons for use in this invention are described in detail hereinafter. , 10In FIG. 4 there is shown a structure similar to FIGS. 2 and 3 except that the front end 18 of outer tube element 12a is substantially closed and comprises a plurality of juxtaposed petal-like flexible segments 18 adapted to open outward when internal pressure is exerted against them as the contents of outer element 12a are pushed therethrough. Such closed-end inserter tubes are well known in the art and need no further detailing here. Note that in this construction the leading end 17 of frontal extension 16 will not extend ~;
beyond the end of the outer tube because frontal exten-sion 16 i8 of less length than outer tube element 12 in order that the tampon will remain totally enclosed within outer element 12a before and during insertion of the delivery device into the vagina. As noted earlier, the length~of the frontal extension 16 can be adjusted to meet the particular requirements of function and tampon design selected by the manufacturer.
After tube element 12a is inserted and the tampon is ejected through and clear of the flexible -~
petals as they open outward when the tampon is pushed therethrough, the tampon, when made of resiliently ,.. . - . - - ,.-.- --.-.-,- ,i .. - . j . .. . . ... . .. . .. ... .. ... . .. ... ..

~0403~1 deformable material, will again begin to expand due to its own resilience in the same way as if the tampon -were ejected from an open-ended tube as in FI~,. 6.
However, when a closed-end tube is used the leadin~
end of the tampon will not be exposed during initial insertion and therefore will not have the wiping action which results when the FIG. 2 embodiment is used.
It is understood, of course, that a shorter frontal extension may be employed on the inner element even when an open-ended outer element is used. In such event, the tampon will not protrude from the front end before or during insertion and the wiping action will not be utilized. Such an arrangement, as with the closed end tube, may be considered more hygienic by the user. If this latter arrangement is used however, the user can elect to partially eject the tampon before inserting the assembly into the vagina and thus utilize the wiping action if needed or desired.
The inner element 16 in addition to having an axial frontal extension should also be provided with means for accommodating the withdrawal string 19 of the tampon. In the FIGS. 1 - 4 embodiments the string accommodating means is provided by making the frontal extension in the form of a hollow tube and the string is threaded through the entire length o that hollow space and through the hollow lower portion 14 of the inner element.
In FIG. 5 the frontal extension 16a is of solid construction. In this embodiment the string is 30 draped along the side of the extension 16a and enters -~

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into the tubular main portion 14 of the inner element through aperture 25. When a solid frontal extension ls used the lower portion of the inner element may also have a groove for the string or be loosely fitted in the outer element to permit the string to be disposed therebetween.
The plan view of FIG. 7 illustrates another tampon 30 made of a multiplicity of thin strips 32, 33 and 34 of absorbent resilient material crossing each other at their geometric center 35 with the free ends of the strips radiating from the center at substantially equally spaced intervals. The strips 32, 33 and 34 are secured together at the crossover area by a suitable withdrawal string 37. The strips are preferably made of hydrophilic polyurethane foam as illustrated in the sectional view of FIG. 8. The strips 32-34 may be a single thickness as shown at 32 in FIG. 8 or multiple thicknesses 32a as shown in FIG. 9. The strip or strips may be used without a strengthening cover as shown in FIG. 8 or may be enclosed in a loose-fitting, non-restricting fluid pervious wrap 36 as shown in FIG. 9.
Such wrap may be woven or non-woven, and may also be hydrophilic or hydrophobic. In addition to reinforcing the foam the wrapper reduces the potential frictional conta¢t between the resiliently deformed tampon and the outer tubular member, as compared to uncovered foam, and thus permits easier ejection from the tampon délivery system.
The foam strips may also be internally reinforced i ' with a light scrim fabric if desired.
FIG. 10 illustrates a preliminary step which may be used in the assembly of the tampon and inserter ... . ~ - . . . . . -.:. ,; . . . , , - , device. As shown therein, the elongate outer tube element 38 which will restrictively contain the tampon is positioned over the geometric center 35 of the unrestrained tampon 30. The leading end 39 of the elongate inner element 40, comprised of a lower main portion 42 dimensioned for slidable association with outer tube element 38 and the upper frontal extension 41 is centrally positioned under center 35 of tampon 30, with withdrawal string 37 threaded through the hollow center of the inner element 40.
When the inner element 40 is advanced in the direction indicated by the arrow, tampon 30 is stuffed into the restricted confines of outer tube 38 and being of a resilient nature is maintained therein in resil-iently deformed condition, particularly in the radial direction.
FIG. 11 shows the tampon 30 partially pushed into outer tube 38.
FIGS. 12 and 13 illustrate the tampon and inserter in fully assembled condition. As shown therein, outer tube 38 is open-ended at its forward end 45. Since tampon 30 is of resiliently deformable material, the head portion of tampon 30 which extends beyond forward end 45 of tube 38 trys to expand to its uncompressed condition and forms a bulbous tip somewhat as shown. Full expansion of the head portion is not obtained because the remaining trailing portion of the tampon is still restricted and compressed inside of tube 38. However, the head portion or leading end of the tampon is partially successful in expanding, and in so doing forms a soft bulbous nose which ,. . ~ .
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is comfortable to insert and also performs the addition- - -ally useful function of swabbing any residual menstrual ; `
fluid from the vagina as it is inserted. This swabbing action removes one of the causes of early tampon failure ~-often ascribed to ~eakage.
It i9 understood that alternatively, the outer tube 38 may be made long enough to contain the entire length of the folded tampon in which case none of the tampon would protrude. Such an arrangement is considered 10 more hygienic by some users. In any event, outer tube ;
38 must be of such length that when the tampon-inserter combination is assembled, at least some part of the ~-tampon remains resiliently deformed within the tube before delivery.
When the tampon 30 is resiliently deformed within outer tube member 38 it is in the form of an inverted cup-like, or test tube-like, shape having an internal vertex 48 at its geometric center. When introduced into the vagina, the tampon will substan-tially retain an inverted cup-like configuration even though it is trying to return to its original unrestrained flat form, because the restricted dimension and internal pressure of the vagina will confine the tampon and prevent complete expansion. As the free ends of the strips try to expand because of the inherent resilience of the strip structure they press against the vaginal walls and substantially conform to the contours thereof, whereby side channel leakage is minimized. In addition, ~ the central strip-crossing area which forms the head of the tampon will be disposed close or adjacent to the -cervix thus placing the maximum thickness of the tampon in an area where the initial menstrual discharge takes place and where optimum absorbent capacity is most needed. Because the individual strips are thin, soft and easily deformable, no difficulties have been found in removing this style tampon even though the uncom-pressed tampon has considerable bulk.
In FIGS. 14-16 there is shown another embodiment of a suitable tampon for use in this invention. This tampon is comprised of a single thin strip 50 of resil-iently deformable material. The strip 50 is made into a tampon by first forming it into a loop with overlapped ends 51 and fastening the overlapped ends together with withdrawal string 57. The thus-formed loop is then flattened, and the flattened loop further formed into a W-configuration as shown in FIG. 16. The inner vertex of the central point in the W forms the support area which is in contact with the leading end 35 of the frontal extension of the inner element. The inner vertex is the point at which internal pushing force is appliçd for the purpose of assembling the tampon-inserter combi-nation, and also for ejecting the tampon during use.
While withdrawal string 57 is shown as pene-trating the upper portion of the tampon loop and securing both top and bottom portions together, the withdrawal string may be used to secure the overlap area only in which case the inner layer of the W is capable of everting during withdrawal to make withdrawal relatively easier. ;~
FIGS. 17-19 show still another embodiment of a suitable tampon for use in this invention. This tampon is comprised of a flat rectangular sheet 60 of resiliently 10403~
deformable material with a withdrawal string 67 attached at one corner. In forming the tampon, sheet 60 is folded twice ln a longitudinal direction as shown in FIG. 18 and then once transversely into an inverted U-shape as shown in FIG. 19. The interior of the inverted U at 65 thus forms the internal vertex where it will be supported by leading end 15a of inner element 40a. As shown in this embodiment, inner element 40a is comprised of a solid frontal extension 41a and a hollow main portion 42a, rather than being hollow through its entire length. In this version of the inner element an aperture 66 is provided at the base of frontal extension 40a to accom-modate withdrawal string 67.
FIGS. 20-24 show an additional embodiment of a tampon particularly suitable for use in this invention.
In these figures, reference is first made to FIGS. 20 and 21 of the drawings in which there is shown a side and top plan view respectively of an embodiment identified as a spheroidal loop tampon.
As shown therein, tampon 72 is made up of intermeshing loops, 73, 74 and 75 of thin, resiliently deformable absorbent strip material to form a tampon having an openwork spheroidal shape. The loops cross , over each other at the top 76 and bottom 77 on the vertical axis of the spheroid. A withdrawal string 78 is attached to and secures together the loops where they cross each other at the bottom 77 of the vertical axis. The substantially spheroidal shape typifies the configuration which this loop embodiment of the invention assumes when it is in its unrestricted, undeformed ~... . , ~ . .. .

~04035-1 condition, which may be oblong or oblate. While this figure shows the loop tampon in its undeformed config-uration, it should be noted here that the tampon assumes -this particular shape only at the time of manufacture ~-and when withdrawn from the vagina after use.
When being prepared for use and for disposition within a suitable delivery or insertion device, the spheroidal shape is first flattened as shown in the top plan view of FIG. 22. The outer tubular element 80 of the inserter device which will receive the tampon in resiliently deformed condition is then positioned on top of the flattened spheroidal tampon concentric with the vertical axis thereof as shown in FIG. 23. The elongate inner element 81 of the inserter device, comprising the main portion 82 dimensioned for slidable engagement within outer tube 80 and the leqser diameter frontal extension 83 has the leading end 84 positioned against the bottom crossover area of the flattened tampon concentric with its vertical axis. The elongate inner element is shown with the preferred hollow config-uration to accommodate the withdrawal string therein, but other string accommodating means can easily be provided.
With the elements of the inserter device and the tampon 72 positioned as indicated in FIG. 23, the inner element 81 is advanced in the direction indicated by the arrow, thereby stuffing tampon 72 into the restricted confines of outer tube 80 and maintaining the tampon 72 in the outer tube in internally supported but resiliently deformed condition.

~0403S~
When spheroidal tampon 72 is resiliently deformed within outer tube element 80 it is in the shape of an lnverted cup. The internal vertex 86 of the inverted cup rests on the leading end 84 of pusher element 81. When tampon 72 is ejected from tube element 80 by pushing against its internal vertex 86, the tampon substantially retains this inverted cup shape even though its inherent resiliency exerts forces which try, unsuccessfully, of course, to reform the tampon to its spheroidal uncompressed shape. The reason the tampon maintains its cup shape while in position in the vagina is that, as is well known, the internal confines of the vagina in its collapsed condition are not much larger than the dimensions of conventionally sized insertion tubes. As a result the vagina itself continually resists expansion of the tampon.
While any resilient material inserted into the vaginal cavity will try to expand, and if resiliently deformable will tend to fill the available space, the material will Ytill generally maintain the shape or form in which it was inserted because of the resistance to expansion provided by the vaginal walls. Accordingly, the tampons described herein will substantially maintain their inverted cup shape after ejection into the vagina.
However, the outer edges of the cup will be continuously trying to expand and in so doing substantially fill the vagina wherever natural voids occur. The tampon also tends to expand further when fluid is absorbed thus still further improving its cavity-blocking function.
Because in the FIG. 20 tampon embodiment, the withdrawal string is attached only to the crossed over strips disposed at the bottom of the intermeshing loops, 1()4Q3Sl :
when withdrawal force is exerted on the strips in this area by pulling on the string, such force will often cause the inner half of the inverted cup to evert and return to its original configuration. In cases where this happens, the tampon will then resume an elongated spheroidal shape as it is extracted. This eversion of the interior of the cup-shape reduces the overall bulk and makes removal of the tampon relatively easy.
In constructing the FIG. 20 tampon, all of the loops may be made from a single continuous strip of material in which case the looped tampon in its sphe-roidal form will have only two free ends to be secured ~, when the withdrawal string is attached at the bottom crossover area. Alternatively, each loop may be made of a single strip with overlapped or butted ends joined together to form each loop.
As in the other tampon embodiments, the stripmaterial may comprise only one ply of resiliently deformable material, or it may comprise a multiplicity of thin plys. When a polyurethane foam strip is used as the base material the tampon may be formed solely of the foam material as indicated previously, or the foam may be strengthened by some form of internal reinforcement such as scrim or the like.
In a preferred form, polyurethane foam is used in the form of a strip which may comprise a single thickness or multiple thicknesses as previously described and is covered with a loosely encircling fluid-pervious fabric wrapper. The wrapper may be woven or non-woven and may also be hydrophilic or , ~04U3Sl hydrophobic, many types of which are well known in the art. The foam strip is loosely wrapped in order not to interfere with, or restrict its potential expansion capabilities.
When the foam strips are thus wrapped, the potential frictional contact between the resiliently deformed tampon and tne outer tube element is consider-ably reduced as compared to foam alone, thus making ejection of the tampon easier. The wrapper also reinforces the foam, and is particularly useful when weak foams are employed.
While the preferred embodiment of the sphe-roidal tampon shown at FIG. 20 in the drawing has three intermeshing loops, tampons made from two or more loops may also be used and generally should be evenly spaced so that the spheroidal configuration does not have uneven gaps.
The following description covers a particularly preferred example of the spheroidal tampon:
Three individual multi-ply strips of hydrophilic polyurethane foam were used. Each strip was 1" wide by 10" long and was comprised of three thinner strips each .060" thick. Each multiply strip was loosely wrapped in a non-woven S x 12 scrim material having a cotton fiber overlay on the outer surface. The strips were formed into loops and the loops intermeshed into a spheroidal shape as shown in FIGS. 1 and 2, with the ends which are overlapped at the bottom to complete the loop joined together at the bottom of the tampon by means of a withdrawal string. The tampon was then flattened and as shown in the drawings pushed, into an outer tube element of polypropylene having an inner diameter 11/16"

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and an outer diameter o ~3~". The absorbent elements of the assembled tampon, including foam strips and wrapper weighed about 3.7 grams. These tampons were then used by members of a clinical panel for catamenial use and compared with conventional tampons. ~ ;
The conventional tampons tested were super size KOTEX~ COMFORTUBE~ Tampons. Such tampons are comprised of a batt of fibers consisting of 20% 3 denier rayon staple, 20% 5.5 denier rayon staple and 60% cotton linters. This batt, which is about 3-1/2" long, 1-1/2"
wide and 3" thick weighs about 3.25 grams and is enclosed in a non-woven 5 x 12 scrim material having a cotton fiber overlay. The wrap material weighed about 0.5 grams per tampon. The tampon was compressed and a~density of 0.85 and a size about 1-1/2" long and 5/8" in diameter, and weighed about 3.75 grams.

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104V3Sl It will be noted from the preceding data that the low density spheroidal tampon was found to be more effective in reducing early leakers than were the conventional highly compressed tampons with which it was compared. In addition it was found equal to or ~-better than most tampons with respect to total capacity and overall efficiency with respect to amount absorbed per unit weight.
It was also found that this spheroidal tampon as tested retained its inverted cup shape while being worn and in some instances when withdrawn was everted by the withdrawal string to provide easy removal as indicated.
As indicated earlier, this inserter device of this invention is particularly designed for soft, low density, easily deformable tampons. Also as indicated earlier, while any soft deformable material may be used, the preferred material for the tampon is one that is resiliently deformable, i.e., it is preferred that it have an inherent springy resiliency which readily compresses under relatively light loads and then springs back to substantially its original configuration as it is worked during insertion and after the load is removed. Small pore, highly absorbent, low density polyurethane foams are particularly useful for this purpose, and since the tampons are intended primarily for catamenial use, the foam should be hydrophilic or mensesphilic.
While the preferréd synthetic sponge materials ~ s such as polyurethane sponge are inherently highly resilient and when compressed tend to return to their uncompressed state when the source of compression is removed, they will sometimes take a temporary set after long term storage or when sterilization procedures are employed.
However, this set is quickly and easily released with very little working such as that applied to it during , the ejection process itself.
As indicated earlier, the foam may also be enclosed in a permeable wrapper material to provide additional strength. The wrapper is preferably loosely fitted to permit the foam to expand without restriction and for better conformance to varying cavity shapes.
Such a wrapper also reduces frictional resistance with respect to the surfaces of the inserter with which it is in sliding contact. The wrapper may be woven or non-woven and can be hydrophilic or hydrop~obic.
The particular shape of the tampon is not critical. Preferably the tampons should be made of an initially thin flat structure which can be readily fleformed into a tube-fitting configuration by pushing the leading end of the frontal extension against the approximate geometric center of the shape selected.
Thin flat sheets, rectangular sheets, circular sheets, irregularly shaped sheets, criss-crossed strips and the like have been found acceptable. The various embodiments described in detail and claimed herein were found to be particularly suitable. Various preliminary folds may also be made in each of these tampons before being compressed into the inserter tube and readied for insertion. In use the leading end of the frontal extension is employed to push against an internal head portion of the tampon disposed as near to the leadlng end of the tampon as is 10403Sl possible when the tampon is in resiliently compressed disposition within the outer tube element. The remaining trailing portion of the tampon is thus readily drawn into -~
the vagina while retaining its relatively uncompressed form.
Also as indicated earlier, the inserter elements are preferably made of smooth flexible plastic material such as polyethylene or polypropylene. Nylon, polyesters and polyvinyls may also be used but generally are not as economically feasible because of fabricating cost.
Paperboard tubes may also be employed.
While in most of the preferred embodiments described in the specification and shown in the drawings, the outer tube element of the inserter device is shown as an open-ended tube, it is understood that the outer tube element may have a substantially closed end of the type now being marketed and shown in section in FIG. 4 in which the forward end of the tube comprises a plurality of juxtaposed petal-like flexible segments which open outward when the tampon is ejected therefrom. This type of inserter will not provide the swabbing action which the open-ended tube structure permits but is considered by some users to be more hygienic. In any event, when combined with an inner support element as herein described, this closed end type of outer tube is also suitable for use in the invention.

Claims (24)

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:

1. An inserter device particularly adapted for delivering soft, easily deformable tampons into body cavities, said inserter being comprised of an elongate outer element and an elongate inner element in telescoping association, said outer element being in the form of a tube, said inner element having a main portion circumferentially dimensioned for slidable engagement within said tube, said main portion having on its forward end an axially disposed elongate extension, said extension being of smaller diameter than said main portion and said extension being of a length which extends through substantially the full length of said tube when said main portion is in slidable engagement with said tube said inserter being adapted to receive a deformable tampon inside said tube with said tampon being centrally supported on the forward end of said inner element while the trailing portion of said tampon is circumferentially and resiliently compressed around the elongate extension of said inner element when said tampon is disposed within said tube.

2. The inserter device of Claim 1 wherein said extension terminates just short of the forward end of said tube.

3. The inserter device of Claim 1 wherein said extension terminates at the forward end of said tube.

4. The inserter device of Claim 1 wherein said extension extends beyond the forward end of said tube.

5. The inserter device of Claim 1 wherein both said main portion and said extension are hollow.

6. The inserter device of Claim 1 wherein said main portion is hollow, said extension is of closed construction and an aperture communicating to the hollow interior of said main portion is provided adjacent the base of said extension.

7. The inserter device of Claim 1 wherein said outer tube has a tapered substantially closed front end, and said tapered front end is composed of a multiplicity of flexible petal-like segments adapted to open outward when internal pressure is exerted against them.

8. In combination, a soft deformable tampon and a delivery system for the tampon, said tampon having a leading head portion and a trailing portion, said delivery system including a first element comprising an outer tube and a second element comprising an inner tube in telescoping association with said outer tube, said second element having a small diameter frontal extension axially disposed on the forward end of said inner tube and extending substantially the full length of said outer tube when the forward end of said inner tube is in slidable association with said outer tube, said tampon being disposed within said outer tube and having the interior of the head portion of said tampon in abutment with the leading end of said frontal extension and having at least the trailing portion of said tampon circumferentially and resiliently compressed around said frontal extension while within said outer tube, whereby when the inner element is telescopically slid into the outer element to eject the tampon therefrom the frontal extension urges said head portion out of said outer tube while drawing the trailing portion out of said outer tube.

9. The combination of Claim 8 wherein said extension terminates just short of the forward end of said outer tube.

10. The combination of Claim 8 wherein said extension terminates at the forward end of said outer tube.

11. The combination of Claim 8 wherein said extension extends beyond the forward end of said outer tube.

12. The combination of Claim 8 wherein said extension is hollow and its interior is in communication with said inner tube.

13. The combination of Claim 8 wherein said extension is of closed construction and an aperture communicating to the interior of said inner tube is provided adjacent the base of said extension.

14. The combination of Claim 8 wherein said outer tube has a tapered substantially closed front end, and said tapered front end is composed of a multiplicity of flexible petal-like segments adapted to open outward when internal pressure is exerted against them.

15. The combination of Claim 8, wherein said tampon is made from thin sheets of resiliently deformable material which material in flat or multifolded form is draped over and downwardly folded around said frontal extension at the approximate geometric center of said material to form a downwardly folded tampon body; said geometric center providing an internal vertex within the downwardly folded tampon against which the leading end of said frontal extension is disposed; the tampon comprised of said downwardly folded material and asso-ciated with the centrally disposed support member being compressively enclosed by and in slidable association with said outer tube.

16. The combination tampon of Claim 15 wherein said resilient material comprises hydrophilic polyurethane foam.

17. The combination of Claim 16 wherein the thin sheet of resiliently deformable material is enclosed in a loosely fitting fluid pervious wrapper.

18. The combination of Claim 17 wherein said wrapper is a non-woven web.

19. The combination of Claim 18 wherein said non-woven web is hydrophilic.

20. The combination of Claim 18 wherein said non-woven web is hydrophobic.

21. The combination tampon and inserter of Claim 15 wherein the sheet material from which said tampon body is formed comprises a plurality of narrow strips of said material, said strips crossing over each at their geometric center with the free ends of said strips radiating outwardly therefrom, said strips being secured together at the cross over area by a withdrawal string, the free ends of said strips being folded downwardly around said geometric center.

22. The combination of Claim 15 wherein the sheet material from which said tampon body is made comprises an elongate strip with the ends of said strip joined by a withdrawal string to form a loop, said loop being flattened and the flattened loop being folded into a W configuration with the string positioned at the internal vertex of the W, and the base of the W forms the downward folded portion and wherein the internal vertex of the W-configurated tampon is positioned on the leading end of said frontal extension.

23. The combination of Claim 15 wherein the sheet material from which said tampon body is made comprises a rectangular sheet having the withdrawal string attached at one corner, said rectangular sheet being folded on itself twice to form a triple laminate of substantially equal width sections, said folded sheet being then folded transversely substantially in half with the extremities providing downward folded portions, the interior area of said transverse fold providing the internal vertex at which the leading end of said frontal extension is disposed.

24. The combination of Claim 15 wherein said tampon comprises a multiplicity of intermeshed loops of thin flat strips of absorbent material which material is resiliently deformable in dry or wet condition, said intermeshed loops being initially disposed to form an openwork spheroid in which said loops cross over each other at the top and bottom of the vertical axis of said spheroid, and said tampon has a withdrawal string securing together the loop areas where they cross over each other at the bottom of said axis, said sphere being collapsed along its vertical axis to juxtapose the top and bottom crossover areas to form a multiplicity of spaced flat loops radiating from the crossover areas, the extremities of said flat loops being depressed to form the intermeshed loops into an inverted cup-shaped tampon, the internal vertex of which is adapted to receive said frontal exten-sion, said frontal extension having its leading end disposed against said vertex, said cup-shaped tampon being resiliently and radially deformed around said frontal extension to a diameter suitable for insertion in the vagina.