U.S. patent number 3,753,437 [Application Number 05/209,273] was granted by the patent office on 1973-08-21 for expandable tampon inserter having a constraining ring.
This patent grant is currently assigned to The Proctor & Gamble Company. Invention is credited to Bernard Allen Dulle, Charles Reay Hood.
United States Patent |
3,753,437 |
Hood , et al. |
August 21, 1973 |
EXPANDABLE TAMPON INSERTER HAVING A CONSTRAINING RING
Abstract
A tampon inserter having one end expandable when subjected to
pressure on its interior surface and an externally mounted,
moveable member which in a first position constrains such expansion
and in a second position allows the one end of the inserter to
expand or move outwardly. The expansion relieves the force between
the interior wall of the inserter and exterior surface of the
tampon, thus lowering the frictional force between the inserter
wall and the tampon.
Inventors: |
Hood; Charles Reay (Cincinnati,
OH), Dulle; Bernard Allen (Montgomery, OH) |
Assignee: |
The Proctor & Gamble
Company (Cincinnati, OH)
|
Family
ID: |
22778103 |
Appl.
No.: |
05/209,273 |
Filed: |
December 17, 1971 |
Current U.S.
Class: |
604/14 |
Current CPC
Class: |
A61F
13/26 (20130101) |
Current International
Class: |
A61F
13/26 (20060101); A61F 13/20 (20060101); A61m
031/00 () |
Field of
Search: |
;128/263,264,285
;3/53 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Recla; Henry J.
Claims
What is claimed is:
1. A tampon inserter comprising:
a. a sleeve, the sleeve having a radially expandable portion, the
expandable portion being adjacent the proximal end of the sleeve,
said expandable portion being expandable by outwardly directed
forces acting on the interior surface of said sleeve;
b. ejection means operatively associated with said sleeve to eject
a tampon contained within the sleeve; and
c. a constraining member coaxially disposed with and being exterior
of said sleeve, said member having minimal frictional engagement
with the unexpanded outside diameter of the expandable portion
whereby a free sliding fit is provided between the inside diameter
of the member and the outside diameter of the unexpanded expandable
portion;
d. the member being positioned in a first position, said first
position being over the expandable portion of the sleeve, and the
member being moveable between the first position and a second
position adjacent the distal end of said sleeve, whereby said
expandable portion is constrained to a comfortably insertable size
with the constraining means in the first position and the ejection
force required to eject a resiliently compressed tampon is reduced
with the constraining means in the second position
e. stop means at said distal end;
f. said member having a labia bearing surface disposed toward the
proximal end of the sleeve, at least 1/3 of the outside periphery
of said labia beating surface being at least about 1/8 inch larger,
on a radius, than the unexpanded periphery of the expandable
portion, whereby said labia bearing surface is large enough to
provide a bearing surface to prevent the said member from
penetrating a vagina during insertion of the inserter
thereinto.
2. The inserter of claim 1 wherein said sleeve has a plurality of
slots through the sleeve wall, said slots extending longitudinally
from the proximal end towards the other end, said slots forming
flexible flaps on the proximal end of said sleeve, said flaps being
radially moveable and forming said expandable portion.
3. The inserter of claim 1 wherein the stop means on the distal end
of the sleeve is in the form of a ring having an outside diameter
larger than the inside diameter of said member.
4. The inserter of claim 1 wherein the wherein the labia bearing
surface is essentially perpendicular to the longitudinal axis of
the member.
5. The inserter of claim 1 wherein the labia bearing surface is
displaced rearwardly from the proximal end of the sleeve with the
member in the first position, said displacement being to provide a
pilot probe at the proximal end of the inserter to aid in starting
the sleeve into the vagina.
6. A catamenial device comprising:
a. the inserter of claim 1, and
b. a tampon resiliently compressed within the sleeve,
c. the tampon being positioned at least partially within the
expandable portion of the sleeve,
d. whereby the resiliently compressed tampon tends to expand the
expandable portion of the sleeve and the member in the first
position prevents the expandable portion from expanding any
appreciable amount.
7. The device of claim 6 wherein the inside diameter of the member
is slightly larger than the outside diameter of the expandable
portion in its unexpanded condition such that the member slides
easily on the expandable portion.
Description
FIELD OF THE INVENTION
This invention relates generally to inserters for tampons and more
particularly concerns inserters wherein one end is radially
expandable to reduce the frictional force between the inserter and
a tampon held therewithin, thereby providing easier ejection of the
tampon from the inserter.
DESCRIPTION OF THE PRIOR ART
In the field of tampon inserters, there have been numerous attempts
to reduce the force required to eject a tampon from the inserter.
The problem of high ejection forces is especially troublesome when
inserting a resiliently compressed tampon having a normal cross
section larger than the cross section of the inserter. The ejection
force required is at least to some substantial extent dependent on
the force necessary to overcome the frictional force between the
exterior surface of the tampon and the interior surface of the
inserter, which is a function of the coefficient of friction
between the inserter and the tampon and the force exerted by the
tampon on the interior of the inserter.
One line of endeavor which has been pursued to reduce the ejection
force is to highly compress the tampon so that it takes a
compressive set and thereby exerts little or no force on the
interior of the inserter. Then the tampon does not tend to spread
an expandable portion of the inserter prior to insertion. Inserters
having an expandable portion and containing therein a compressed
tampon are taught in the following U.S. Pat. No. 2,733,714, issued
to E. C. Haas on Feb. 7, 1956; 3,204,635, issued to J. A. Voss et
al. on Sept. 7, 1965; U.S. Pat. No. 3,347,234, issued to J. A. Voss
on Oct. 17, 1967; and U.S. Pat. No. 3,433,225, issued to J. A. Voss
et al. on Mar. 18, 1969.
Another approach taken to the problem of the high ejection forces,
particularly directed toward inserting resilient tampons, is taught
in the following U.S. Pat. Nos. 61,417, issued to W. G. Grant on
Jan. 22, 1867; 1,969,671, issued to A. Nelson on Aug. 7, 1934; and
2,884,925, issued to M. J. Meynier, Jr. on May 5, 1959 wherein the
expandable portion of the inserter is prevented from expanding
during insertion but is expanded or allowed to expand after
insertion. While each of these approaches have met with some
success, there has been a continuing search for an inserter which
provides, especially for a resiliently compressed tampon, a low
ejection force, and one-step insertion and placement of the tampon
without requiring steps before or after the insertion, in
conjunction with an inserter which is simple, reliable, easy to
use, and economical enough to be disposed of after use.
OBJECTS OF THE INVENTION
It is an object of this invention to provide an inserter wherein
the ejection force required to remove a resiliently compressed
tampon from within the inserter is reduced. It is an additional
object of this invention to provide an inserter having an
expandable portion which is positively constrained from expanding
until the inserter is put into the body opening. Also, it is an
object of this invention to provide an inserter wherein the means
constraining the expandable portion of the inserter is reliably and
easily removed during insertion. It is a further object of this
invention to provide an inserter having an expandable portion, said
inserter being economical so it can be displaced of after one
use.
SUMMARY OF THE INVENTION
In accordance with the present invention, there is provided a
tampon inserter comprised of a sleeve for holding a resilient,
elastic, dry expanding tampon in a resiliently compressed
condition, the sleeve having a radially expandable portion adjacent
its proximal end, and the expandable portion being expandable by
outwardly directed forces acting on the sleeve's interior surface;
ejection means operatively associated with the sleeve and bearing
on a tampon within the sleeve; and constraining means operatively
associated with the sleeve and being slideably moveable between a
first position on the sleeve whereat radial expansion of the
expandable portion is prevented and a second position on the sleeve
whereat the expandable portion is free to radially expand. The
constraining means is intended to prevent expansion of the
expandable portion until insertion of the sleeve into a vagina is
started.
BRIEF DESCRIPTION OF THE DRAWINGS
While the specification concludes with the claims particularly
pointing out and distinctly claiming the subject matter which is
regarded as forming the present invention, it is believed that the
invention will be better understood from the following description
taken in connection with the accompanying drawing, in which the
thickness of some of the materials is exaggerated for clarity and
in which:
FIG. 1 is a fragmentary perspective view of a preferred embodiment
of the inserter of this invention having a tampon resiliently
compressed within its expandable end;
FIG. 2 is a side view of a sleeve having an alternative embodiment
of the expandable portion of the sleeve;
FIG. 3 is a front view of the alternative embodiment shown in FIG.
2;
FIG. 4 is a side view of a sleeve showing another alternative
embodiment of the expandable portion of the sleeve;
FIG. 5 is a front view of the alternative embodiment shown in FIG.
4;
FIG. 6 is a perspective view of an alternative embodiment of a
constraining means; and
FIG. 7 is a side view of a sleeve showing an open proximal end
configuration.
DETAILED DESCRIPTION OF THE INVENTION
Referring to FIG. 1 there is shown an inserter of this invention
having a sleeve 21, a telescoping tube ejector 22 as the ejection
means, an annular member 23 as the constraining means, and a
resiliently compressed tampon 29 within the sleeve 21. The tampon
29 is resiliently compressed by forcing it into the sleeve 21
either by hand or with a machine (not illustrated). As used herein
resiliently compressed is intended to mean compressed to a degree
where permanent set, i.e., cold flow to or a bonding in a
compressed configuration, has not occurred. A resiliently
compressed tampon will return to its unrestrained shape after being
released, although the passage of time or a moderate flexing of the
resiliently compressed tampon may be required to return the tampon
to its uncompressed form. A resiliently compressed tampon is dry
expanding in that it expands from its resiliently compressed
configuration without relying on the actions of fluids to release
compression set which may have taken place within the tampon due to
compressing it.
The sleeve 21 can be formed similarly to the outer tube of a
telescoping tube type inserter, such as are well known to those of
ordinary skill in the inserter art. It can have an open proximal
end 27 wherein the diameter of the sleeve is uniform out to the
proximal end as is shown in FIG. 7, or it can have a closed,
inwardly-tapering proximal end, some examples of which are shown in
FIGS. 1, 2 and 4. In a sleeve such as is shown in FIG. 1 having a
proximal end 27 which is closed by means of inwardly-tapering
flexible panels or flaps 30 (hereinafter referred to as flaps), the
expandable portion of the sleeve is adjacent the proximal end 27.
The expandable portion is formed by providing slots 24 (or slits if
so desired, but hereinafter referred to as slots) in the sleeve
wall which extend from the proximal end 27 rearwardly for a
substantial distance. The slots 24 can, but do not necessarily have
to, lie on or be coincident with radial planes of the sleeve 21. A
flap in the preferred embodiment is the portion of the sleeve
between two adjacent slots 24 in the expandable portion of sleeve
21. A substantial distance is that distance required to permit
ejection of the expandable tampon 29 from the sleeve with an
ejection force of about 1,000 grams or less, preferably less than
500 grams, exerted on the inner tube 22. Lengthening the slots 24
provides a longer cantilever arm in each of the flaps 30 and
permits easier flexure and radially outward movement of each flap
30, thus easier ejection of a tampon 29. The longer the cantilever
arm, i.e., the distance from the distal end to the proximal end of
a flap 30, the easier and greater will be the expansion of the
proximal end of the sleeve for a given outwardly directed internal
force. An expandable portion which will expand readily to reduce
the ejection force should be at least 1/2 inch long or extend
toward the distal end a distance which is at least 25 percent of
the length of the tampon restrained therein.
A sleeve which has been found to work well is about 3 inches long,
has an inside diameter of about 0.640 inches, has an outside
diameter of about 0.710 inches, has slots which are about 1.5
inches long, and is molded in polyethylene. But it is to be
understood that the dimensions may be varied and the sleeve can be
made from any of the other materials commonly known to those
skilled in the art, for example, paper.
In the preferred embodiment, the sleeve 21 has a stop at its distal
end, for example, such as the stop 31 as is shown in FIG. 1. The
stop 31 is provided to prevent the annular member 23 from moving
beyond the distal end of the sleeve 21.
The expandable portion of the sleeve 21 can also be formed such as
is shown in FIGS. 2 and 3, i.e., by dovetailed infolding of the
sleeve wall to reduce the diameter of the sleeve in the folded
configuration and allow expansion to the original diameter when the
folds are removed. In this embodiment, the folds can extend the
entire distance of the expandable portion, or slots such as 33 can
be incorporated to extend the expandable portion beyond the folds.
Such dovetailed folding could also be used in a sleeve wherein the
diameter of the expandable portion is originally larger than the
diameter of the nonexpandable portion and the dovetailed folding
reduces the expandable portion to a diameter equal to or less than
the diameter of the non-expanding portion of the sleeve (not
illustrated). Another structure providing an expandable portion of
the sleeve is shown in FIGS. 4 and 5 wherein slots 34 are cut into
the sleeve wall to form flaps 32. These flaps 32 are then folded
together to form a reduced cross section in the end of the sleeve
by inwardly tapering the flaps 32 and superposing the edges of some
flaps 32 over the edges of adjacent flaps as shown in FIGS. 4 and
5. Slots such as 34 can be incorporated to extend the expandable
portion beyond the end closing mechanism. Again, the expandable
portion diameter could be originally larger than the nonexpandable
portion diameter and reduced to a diameter the same as or smaller
than the nonexpandable portion diameter.
An open-end sleeve is shown in FIG. 7 wherein the expandable
portion is formed by cutting slots 35 in the wall of the sleeve.
There are, of course, many other structures which will provide an
expandable portion for a sleeve.
The annular member 23 can be of various shapes and designs, one of
which is a teardrop shape as is shown in FIG. 1 and another is a
spool shape member 23' such as is shown in FIG. 6. A preferred
embodiment is the teardrop shape as is shown in FIG. 1. The annular
member encompassing the sleeve 21 in the expandable portion
provides a constraining means which prevents the expandable portion
from increasing in diameter when there is a resiliently compressed
tampon held therein. The annular member preferably has an inside
diameter which closely fits the exterior diameter of the
nonexpanding portion of the sleeve 21.
The annular member 23 is shown in solid outline in its first
position 25 whereat it constrains the expandable portion of the
sleeve 21 to a comfortably insertable size. A comfortably
insertable size is generally considered to be less than about 0.75
inches in diameter. Larger diameters require excessive dilation of
the vaginal introitus. The annular member 23 is slideable along the
sleeve to its second position 26, as shown in FIG. 1 by the dotted
outline whereat it does not constrain the expandable portion and
thus the walls of the sleeve in the expandable portion can move
outwardly, relieving the force of the sleeve 21 on the resiliently
compressed tampon 29, lowering the frictional force between the
sleeve and the tampon.
The coefficient of friction between the annular member 23 and the
exterior surface of the sleeve 21 should be low enough so the
annular member 23 can be moved from its first position 25 to its
second position 26 during insertion with a force of less than about
1,000 grams, and preferably with a force of less than about 500
grams. This force should be the maximum force required with a
resiliently compressed tampon positioned within the expandable
portion of the sleeve 21. It has been found that insertion and
ejection forces greater than about 1000 grams are unacceptable to
inserter users.
An annular member which has worked well with the sleeve as above
described is about 1 inch long, has an O.D. of about 1.12 inches,
an I.D. of about 0.720 inches, and is made from polyethylene.
The preferred embodiment of the annular member 23 should have a
proximal end 28, i.e., that end which contacts the labia minora or
hymenial area during insertion, which is substantially
perpendicular to the longitudinal axis thereof and of sufficient
area to provide a bearing surface on the proximal end 28 of the
annular member 23. This bearing surface is provided to prevent
penetration of the annular member beyond the introitus and into the
vagina during insertion. The bearing surface on the proximal end 28
of the annular member 23 should be of such a shape and area that
the annular member 23 moves from its first position 25 to its
second position 26 without penetrating the vaginia during
insertion. It has been discovered that the proximal end 28 of the
annular member 23 should be at least about 1/8 inch larger on a
radius than the unexpanded diameter of the sleeve 21 underlying the
proximal end 28 of the annular member 23 and this larger diameter
should cover at least about 1/3 of the circumference, preferably
1/6 at each termini of a diameter, to prevent the annular member 23
from penetrating the vagina. An annular member of the
aforementioned dimension provides an acceptable bearing surface on
the proximal end 28 of the annular member 23.
As shown in the preferred embodiment, the stop 31 determines the
second position 26 of the annular member 23 and controls the depth
to which a tampon is inserted by controlling the length of inserter
beyond the proximal end 28 of annular member 23.
To establish the first position 25 of the annular member 23, it has
also been found preferable, although not absolutely necessary, to
displace the bearing surface on the proximal end 28 of the annular
member 23 rearwardly from the proximal end 27 of the sleeve 21, as
is shown in FIG. 1. This displacement provides a pilot probe, i.e.,
the portion of the sleeve 21 in front of the proximal end 28 of the
annular member 23, for locating the introitus during insertion. The
minimum displacement to provide an effective probe is about 1/4
inch, and preferably about 1/2 inch.
It is also preferable to make the annular member 23 long enough so
that in its first position 25 it covers and exerts a constraining
force on a substantial part of the expandable portion of the sleeve
21, e.g., with a sleeve wall thickness of about 0.025 inch as in
the above described sleeve, it is preferable that no more than
about 1/2 inch of the expandable portion be exposed unconstrained
distally from the annular member 23. The length of expandable
portion which can be permitted to be unconstrained distally from
the annular member varies with and depends upon the "beam strength"
of the flaps in the unconstrained area. Covering and exerting the
constraining force is especially important if the sleeve is weak
enough that a resiliently compacted tampon therewithin will cause a
bulge, i.e., radial expansion, in any part of the expandable
portion rearward from the first position 25 which is not overlaid
by a part of the annular member 23. A bulge behind the annular
member 23 will increase the force required to move it to its second
position 26 and therefore bulges are to be avoided. The annular
member 23 of the above dimensions in combination with the sleeve 21
as above described is satisfactory to prevent bulges.
The tampon 29 is any tampon which exerts an outwardly directed
radial force on the sleeve 21 and in particular the resiliently
compressed dry expanding tampons, e.g., one as taught in the
co-pending, commonly owned, U.S. patent application entitled
Compliant Comformable Tampon, by Bernard A. Dulle, filed Aug. 18,
1971, Ser. No. 172,694. That co-pending application teaches a
generally conically shaped tampon having a polyurethane foam
absorbent body which has a dry material modulus of compression of
about 0.4 pounds per square inch. The tampon is hollowed out, has a
height of about 2.25 inches, and a base diameter of about 2.25
inches. Said application is incorporated herein by reference.
The inserter of this invention provides benefits, as mentioned
above, whether the sleeve 21 is of the open or closed proximal end
configuration. But, the fullest advantages of the inserter of this
invention are realized when the sleeve 21 is of the closed end
design because in that design the ejection force must be sufficient
to open up the closed end during ejection in addition to overcoming
the static frictional forces between the tampon and the inside wall
of the sleeve 21. Making any flap such as 30 weaker, so it can be
flexed open easier, greatly reduces the ejection force required to
remove the tampon 29 from the sleeve 21. The flaps 30 are
appreciably weakened by lengthening the slot 24 in that the
cantilever arm is lengthened as above described. Thus, the annular
member 23 in its first position 25, i.e., covering at least some of
the expandable portion of the sleeve 21, adds strength and rigidity
to the flaps 30 and prevents them from expanding until the annular
member 23 is moved to its second position 26 whereby the expandable
portion of the sleeve 21 is completely uncovered and the flaps are
free to expand radially outwardly.
The inserter of this invention may be used in several ways. One way
is to hold the inserter between the thumb and middle finger on
opposite sides of the distal end of the innertube 22 and spread the
labia with the other hand. The user then pushes the proximal end 27
of the sleeve 21 into the vagina. The sleeve progresses into the
vagina and the proximal end 28 of the annular member 23, the
bearing surface, eventually contacts the labia or the hymenial
area, at which time the annular member 23 slides rearwardly along
the sleeve 21 to the second position 26 as determined by the stop
31. The inserting pressure is continued and forces the innertube 22
through the sleeve 21, thereby ejecting the tampon 29 through the
proximal end 27 of the sleeve 21.
Another method of using this inserter is to grasp the annular
member 23 with the thumb and middle finger on opposite sides of the
annular member 23 and place the index finger at the distal end of
the inner tube 22. The labia are spread with the other hand and the
inserter is pushed into the body while simultaneously pulling the
annular member 23 toward the distal end of the sleeve 21 to its
second position 26, and then ejecting the tampon 29 from the sleeve
21 by pushing on the distal end of the inner tube 22 with the
middle finger.
Also this inserter can be used by gripping the distal end of the
sleeve 21 between the thumb and middle finger, spreading the labia
with the other hand, pushing the proximal end 27 into the vagina
with the labia or hymenial area pushing the annular member 23
rearwardly to its second position 26. Then the index finger is
placed on the distal end of the inner tube 22 and the inner tube 22
is pushed by the index finger to eject the tampon 29 from the
proximal end 27 of the sleeve 21.
Thus it is apparent that there has been provided in accordance with
the invention, an inserter that fully satisfies the objects, aims,
and advantages set forth above. While the invention has been
described in conjunction with the specific embodiments thereof, it
is evident that many alternatives, modifications, and variations
will be apparent to those skilled in the art in light of the
foregoing description. Accordingly, it is intended to embrace all
such alternatives, modifications, and variations as follows in the
spirit and broad scope of the appended claims .
* * * * *