Tampon applicator arrangement

Details Tampon applicator arrangement Tampon applicator arrangement

2001-08-06

2003-08-26

Ruhl, Dennis (Department: 3761)

Surgery

Means for inserting fibrous or foraminous resident packing,...

Distal portion of inserting means deformed, expanded, or...

Reexamination Certificate

active

06610025

ABSTRACT:

FIELD OF THE INVENTION
This invention relates to an applicator-tampon arrangement, specifically having a film cap positioned over the tampon or applicator, which has an improved insertion in use. The invention also provides methods for making such applicator-tampon arrangements.
BACKGROUND OF THE INVENTION
A wide variety of absorbent catamenial tampons and applicators have been described. The applicator is typically a device to facilitate the insertion of the tampon into the body. They are typically made from cardboard or plastic. Current commercially available applicators include for example those, which comprise two tubes, telescoped one in another, whereof one tube can move inside the other tube, to push the tampon therein forward and thereby expelling it into the vagina. The applicator is then removed from the vagina, leaving the tampon behind. Another common applicator-tampon arrangement is in the form of a plunger with an inserter tube.
It is of course desirable that the insertion of the applicator is such, that the user does not feel any discomfort while inserting the applicator or while removing the applicator. Many attempts have been made and many solutions have been proposed to provide easier, smoother insertion of tampon-applicators.
In particular, with open-ended applicators, the edge of the inserter tube, which typically enters the vagina first, can be sharp and can scrape and hurt the vagina, or even external body tissue, such as the labia, during insertion. Furthermore, the exposed head of the dry tampon can drag and can make the insertion of the applicator into the vagina uncomfortable. Also, the tube often comprises petals, extending from the top edge of the tube, which are inserted into the vagina and which open when the tampon is pushed out of the tube. The petals are normally sharp and stiff and can hurt the vagina or even external tissue, in particular if a petal is slightly bent out of plane, prior to insertion.
One proposed solution hereto, for example described in U.S. Pat. No. 3,760,808, is to provide the outer tube with a sack of film, which covers this outer tube and thereby makes the outer tube edge less sharp. The tampon can be pushed through said film sack by applying enough pressure on the inner tube. The sack is made by welding films together, and then making lines of weakness, and placing this over the outer applicator, and by inverting the sack onto and down the exterior of the outer tube, to position it between the outer tube and inner tube, as to hold the sack in place.
Whilst such sacks may make the edge of the tube smoother, it does not always result in reduced discomfort for the user. Namely, the sack itself creates other rough edges, rugosites and folds by the way it is applied to the tampon/applicator, thereby leaving spare sack material, which will hinder the insertion of the tampon into the body, hinder the expulsion of the tampon through the film and form potentially sharp folds or wrinkles when introduced in the vagina under pressure. Also, the described sack comprises potentially sharp welds in the sack.
Furthermore, the inventors found that, due to the way the sack-arrangement is formed, e.g. from quite extensible film, the expulsion of the tampon through this type of sack is difficult and it will require the use of a lot of pressure by the user on the applicator, which results in discomfort. The inventors also found that, since this sack is only fixed to the applicator outer tube at the bottom peripheral edge, there is not only a high risk of unintended separation of the sack and the outer tube during insertion, but moreover, there is a problem because this allows the sack film below the tube edge to also extend and thereby increase the extension of the total sack and the work needed to expel the tampon during insertion; both problems occurring in particular since high pressure needs to be used by the user to expel the tampon, due to the construction of the sack-arrangement. Thus, there is a high risk that some or all of the sack comes loose and is left behind in the vagina. Furthermore, the method of making the sack, as described in this document is complex, involving a number of separate steps, including a cumbersome step of inverting the sack when it is applied to the outer tube.
Another method to provide soft insertion of a tampon-applicator arrangement in the vagina is described in U.S. Pat. No. 5,928,183. It is described to provide an applicator which has a specific insertion tip of pleated layers of thin material, folded upon it self, which is said to facilitate expulsion of the tampon. Whilst insertion of a tampon with this applicator may not require large forces, the pleated film can cause discomfort, because the folds can comprise sharp edges, in particular, the topmost portion of the pleat ends are often located at the leading edge of the applicator-tampon arrangement during insertion, and are thus directly in contact with the body, resulting in a high risk of wounding the vagina, labia or other body tissue. Further, during insertion into the body, the pleated film could drag against body tissue; and, inadvertently and pre-maturely fold back or invert away from the tampon head toward the applicator tube thereby causing user discomfort as well as exposing the dry tampon to body tissue during the remainder of the insertion process.
Thus, whilst the provision of such sacks of the prior art can reduce the friction to some extent, providing a smoother insertion, they are not always safe or smooth enough, or raise other problems such as an increase in expulsion force.
The inventors have now found that in order to provide a smooth and safe insertion of the tampon-applicator arrangement, the film cap must be such that it ruptures on a specific moment, when a specific low, maximum force is applied, whilst the cap should still be attached such that it does not leave residues in the body. The improved tampon-applicator arrangement of the inventors has an improved cap construction, which provides an easier, smoother, safer insertion of the tampon-applicator arrangement, and requires a lower force to expel the tampon from the applicator in the vagina.
The inventors have also found an improved process to make applicator-tampon arrangements with a film cap, which is not only a very simple, industrially feasible process, but also results in even smoother, safer and easier to insert tampon-applicator arrangements. The applicator-tampon arrangements obtained by the process have a film cap which conforms to the tampon or applicator with no areas where spare film material can form loose (and often sharp) folds or wrinkles; the arrangements obtained have an improved expulsion profile, reduced risk of leaving film residues (in the body) and reduced risk of harm to the body. Unlike the prior art processes, the process of the invention results (in only one or more separate, industrially feasible, easy process step(s)) in film caps which may even be free of any rugosites or loose folds (e.g. not under tension) or preferably even free of seams and/or welds, and which are thus much smoother.
Thus, film caps can be produced which do not have any uncomfortable and even problematic folds, seams, welds or overlaps, as the sacks of the prior art do. Moreover, by use of the process of the invention, the quality of the film caps formed thereby can be much more controlled, including the provision of the specific expulsion profiles and extension profiles of the film cap and/or arrangement of the invention.
SUMMARY OF THE INVENTION
The present invention relates a tampon and applicator arrangement comprising a tampon and an applicator unit, capable of receiving a tampon, whereby the tampon and applicator unit each have a bottom side and a top portion with a topside, whereby the arrangement has a film cap over or on said tampon or applicator unit, or part thereof, characterised in that the top portion of the film cap, present over or on the top portion of the tampon and/or the top portion of the applicator unit is uniformly shaped, and that said film cap i

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