Note: Descriptions are shown in the official language in which they were submitted.
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APPLICATOR DEVICE
FIELD OF THE INVENTION
The present invention generally relates to applicators that have a
locking/snap-
in mechanism and that are capable of housing an insertable element and in
particular a
tampon applicator that provides the user with a tactile perceptual cue,
indicating that
the insertable element is appropriately deployed, e.g., fully expelled.
BACKGROUND OF THE INVENTION
Applicators, as known in the art, are used to house objects intended to be
inserted in a body cavity, such as a tampon and to expel the objects into the
intended
orifice. Typically, applicators comprise an insertion member and a plunger.
The object
to be expelled from the applicator, such as a tampon, is positioned within the
insertion
member. The insertion member has a first end for insertion of the tampon and a
second
end for receipt of the plunger. To use the applicator, the user will position
the first end
appropriately, grasp the insertion member, and push the plunger into the
insertion
member towards the first end to insert the tampon. A variety of applicators
have
employed visual marks to determine when the contents of the applicator have
been
fully expelled.
Various locking mechanism configurations have been proposed to facilitate the
handling of the applicator and to improve insertion thereof. One approach is a
tampon
applicator as disclosed in U.S. Pat. No. 2,587,717, with a locking mechanism
comprising of a locking ear punched inwardly in the barrel and a plunger
having a
locking ear that points inwardly into the interior of the plunger. Locking
occurs when
the both ears are engaged with each other and the plunger is prevented from
removal
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due to the locking ear of the barrel catching an open area created by the
locking ear of
the plunger. Another approach is a tampon applicator as disclosed in U.S.
Patent No.
3,347,234 comprising an applicator provided with means to stabilize the
position of the
inner tube with the outer tube. The stabilizer means may be in the form of
small detent
or flaps extending downwardly and forwardly form the outer tube. The detents
inhibit
rearward withdrawal of the inner tube from the outer tube, but do not inhibit
the
forward movement or the inner tuber relative the outer tube.
Where as these designs have functioned well for their intended purposes, there
still remains a need for a tampon applicator having an improved locking
mechanism.
Accordingly, it is believed that the design of the present invention will
provide an
applicator with an improved locking mechanism comprised of an insertion
member, a
plunger member, and compatible locking mechanisms for each member that will
improve the user's insertion experience as well as provide the user with a
visual cue
upon locking.
The citation of any document herein is not to be construed as an admission
that
it is prior art with respect to the present invention.
SUMMARY OF THE INVENTION
An applicator device capable of housing an insertable element has an insertion
member having an insertion end and an opposed gripper end, a plunger
insertable into
the gripper end of the insertion member and having an insertion end and an
opposed
gripper end, and a locking mechanism comprising at least one plunger lock
element and
at least one insertion member lock element. The plunger is slidable in the
insertion
member between a first position, substantially contained within the insertion
member
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with the plunger insertion end disposed toward the insertion member insertion
end, and
a second position, substantially withdrawn from the insertion member. The at
least one
plunger lock element and the at least one insertion member lock element are
capable of
engaging when the plunger is disposed in the first position. In one
embodiment, the at
least one plunger lock element is spaced apart from the gripper end of the
plunger, and
the at least one insertion member lock element is spaced apart from the
gripper end of
the insertion member. In another embodiment, the at least one plunger lock
element is
disposed proximate the gripper end of the plunger, and the at least one
insertion
member lock element is disposed proximate the gripper end of the insertion
member.
A method of inserting an element into a body cavity includes the steps of
inserting into the body cavity an applicator, sliding the plunger of the
applicator into
the insertion member, expelling an insertable device from the insertion end of
the
applicator and into the body cavity, and withdrawing the applicator from the
body
cavity by withdrawing its plunger. The applicator includes an insertion member
having
an insertion end and an opposed gripper end, a plunger insertable into the
gripper end
of the insertion member and having an insertion end and an opposed gripper
end, and a
locking mechanism. The locking mechanism includes at least one plunger lock
element
and at least one insertion member lock element. The at least one plunger lock
element
engages the at least one insertion member lock element. Again, the plunger is
slidable
in the insertion member between a first position, substantially contained
within the
insertion member with the plunger insertion end disposed toward the insertion
member
insertion end, and a second position, substantially withdrawn from the
insertion
member. Preferably, the detection of the engagement of the at least one
plunger lock
element and the at least one insertion member lock element permits the user to
determine appropriate deployment of the insertable device in the body cavity.
The
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engagement of the at least one plunger lock element and the at least one
insertion
member lock element remain continues during the withdrawal of the plunger to
remove
also the insertion member.
BRIEF DESCRIPTION OF THE DRAWINGS
Examples of embodiments of the present invention will now be described with
reference to the drawings, in which:
Fig. lA is a side elevation of an applicator according to the present
invention
comprising a tubular insertion member and a plunger member disposed therein;
Fig. 1B is a partial side elevation of the applicator of Fig. lA after
complete
insertion of the plunger member into the insertion member;
Fig. 2A is a longitudinal section of a device according to Fig. 1;
Figs. 2B and 2C are cross sections of the device along line 2-2 of Fig. 2A;
Figs. 3-5 are partial longitudinal sections of alternative embodiments of the
present invention;
Fig. 6A is a longitudinal section of an alternative embodiment of the present
invention;
Fig. 6B is a cross section of the device along line 6-6 of Fig. 6A;
Figs. 7A-9 are partial longitudinal sections of alternative embodiments of the
present invention;
Fig. 10 is a partially cut away longitudinal section of an alternative
embodiment
of the present invention;
Figs. 11 and 12 are partial longitudinal sections of the insertion and gripper
ends of alternative embodiments of the present invention;
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Figs. 13 and 14 include a side elevation of alternative plunger members of the
present invention and a gripper end view of alternative insertion members of
the
present invention;
Figs. 15 and 16 are partial longitudinal sections of alternative embodiments
of
the present invention;
Fig. 17 shows partial longitudinal sections of two stages of insertion of a
plunger member into an insertion member according to an alternative embodiment
of
the present invention; and
Figs. 18A-18C show partial longitudinal sections of three stages of insertion
of
a plunger member into an insertion member according to an alternative
embodiment of
the present invention.
DETAILED DESCRIPTION OF THE INVENTION
As used herein the specification and claims, the term "applicator" refers to a
mechanism or implement that facilitates the insertion of a tampon or other
structure
into an external orifice of a mammal. The term includes, without limitation,
any known
hygienically designed applicator that is capable of receiving a tampon and may
be used
for insertion of a tampon, including the telescoping, tube and plunger and the
compact
applicators, an applicator for providing medicament to an area for prophylaxis
or
treatment of disease, a spectroscope containing a microcamera in the tip
connected via
fiber optics, a speculum of any design, a tongue depressor, a tube for
examining the ear
canal, a narrow hollow pipe for guiding surgical instruments, and the like.
As used herein the specification and claims, the term "tampon," refers to any
type of absorbent structure that is inserted into the vaginal canal or other
body cavities
for the absorption of fluid therefrom, to aid in wound healing, or for the
delivery of
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active materials, such as medicaments, or moisture. The tampon may be
compressed
into a generally cylindrical configuration in the radial direction, axially
along the
longitudinal axis or in both the radial and axial directions. While the tampon
may be
compressed into a substantially cylindrical configuration, other shapes are
possible.
These may include shapes having a cross section that may be described as
rectangular,
triangular, trapezoidal, semi-circular, hourglass, serpentine, or other
suitable shapes.
Tampons have an insertion end, withdrawal end, a length, a width, a
longitudinal axis,
and a radial axis. The tampon's length can be measured from the insertion end
to the
withdrawal end along the longitudinal axis.
As used herein the specification and the claims, the term "rigidity" and
related
terms mean the longitudinal stability of the device. Normally specified as the
unit for
rigidity is the force that is necessary to compress the element in the
longitudinal
direction by a specific length (N/cm).
As used in the specification and claims, the term "aperture" and variants
thereof, mean an opening in the surface of the tubular insertion device which
forms a
discontinuity in the tube-forming material at the edges of the opening, at
least at the
leading and trailing edges thereof. This aperture thereby provides relatively
abrupt,
finger-accepting edges to frictionally resist movement of a user's finger in
response to
longitudinal forces on the device.
While the present invention generally relates to applicator devices having a
tubular insertion member, the following detailed description will refer,
specifically, to a
locking tampon applicator for ease of understanding. One of ordinary skill in
the art
will recognize other uses for this invention including, without limitation,
applicators for
other intravaginal devices, such as collection cups, inflatable plugs or cups,
and the
like; incontinence devices; suppositories; nasal packing; and the like.
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The present invention relates to applicators for delivering materials into
body
cavities, comprising an elongate insertion member and a plunger member having
locking mechanisms for at least partial insertion into a body cavity. The
elongate
insertion member has an insertion end and gripper end opposite thereof. The
plunger
member has an insertion end and gripper end opposite thereof.
Referring now to the drawings, wherein like reference numerals designate like
elements, FIG. 1 depicts an applicator 10, comprising a tubular insertion
member 12,
having an insertion end 14 and a gripper end 16 that is suitable to contain an
insertable
device 18 for the body cavity. The insertion end 14 may have a plurality of
inwardly
curved petals 20 that form a substantially closed insertion end, and the
gripper end 16
may have a structure 22 to enhance the user's grip on the applicator. The
applicator 10
also includes a plunger member 24 having an insertion end 26 that is
insertable into the
tubular insertion member 12 and is capable of bearing against the device 18.
The
plunger member 24 terminates in a gripper end 28, opposite the insertion end
26, that
may be manipulated to move the insertion end 26 within the tubular insertion
member
12. The insertion end 26 of the plunger member 24 is arranged and configured
for
slidable introduction into the tubular insertion member 12 through its gripper
end 16.
The applicators 10 or other tubular devices of the present invention can have
tube geometries or cross-sections that are useful to contain the object to be
inserted.
Often, the shape of the insertable device 18 contained suggests the shape of
the tubular
insertion member 12, but departures from this general rule may be made.
Therefore,
the tubular insertion member 12 may take on numerous cross-sectional shapes
including, without limitation, circular, oval, polygonal (e.g., trapezoidal,
rectangular,
triangular), and the like. For example, cylindrical tampons may be contained
within
rectangular insertion members and trapezoidal tampons (such as those disclosed
in Van
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Iten et al., US Pat. No. 5,350,371) and cup-shaped tampons (such as those
disclosed in
Bailey, US Pat. No. 2,330,257) can be contained in a generally cylindrical
insertion
member. In addition, the insertion member 12 can substantially elongated,
curved, or
flexible, or it can take on other shapes that are apparent to one of ordinary
skill in the
art. The specific geometry, itself, is not critical to the practice of the
present invention.
In addition, the edge of the tubular device (both finished and unfinished) may
be a
standard, planar edge coincident with a plane perpendicular to the
longitudinal axis of
the tubular device.
The applicator devices of the present invention can be made of materials known
to those of ordinary skill in the art. Generally, the applicators may be
plastic or paper.
Plastic materials include, without limitation, polyolefins such as
polyethylene and
polypropylene, polyesters such as polyethylene terephthalate,
polycaprolactone,
polyvinyl alcohol, ethylene-vinyl acetate copolymers, cellophane, PHBV such as
those
disclosed in Dabi et al., US Pat. No. 5,910,520 (herein incorporated by
reference),
starch-based polymers including those disclosed in Dabi et al., US Pat. No.
5,910,520,
and the like. The expulsion member can be formed as a solid or a tubular
element.
Paper materials include, without limitation, paperboard, cardboard, cup stock,
paper, and the like. The paper may be a single layer of material, or it can be
a plurality
of laminated layers to provide multiple benefits relating to the various
layers.
Laminated paper material may include a surface layer or coating of plastic,
wax,
silicone, lubricants, and the like, which may be useful to increase the
comfort to the
user during insertion and withdrawal. The plastic coating may include, without
limitation, those plastic materials listed above. Laminated paper material may
also
include additional layers such as adhesive layers, tie layers, and the like.
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An example of such a surface layer is disclosed in Blanchard, US Pat. No.
6,171,426. A representative, non-limiting list of useful materials to be used
as the
surface layer includes, waxes, cellophane, polyolefins, polyesters, epoxies,
and the like.
The surface layers may also include thermal stabilizers, pigments, fragrances,
surfactants, antimicrobial agents, medicaments, and the like.
Typical dimensions for each of the tubular insertion and plunger members
include a length of from about 50 to about 100 millimeters, a diameter of from
about 8
to about 16 millimeters, and a thickness of from about 0.4 to about 0.6
millimeters.
Preferably, the diameter of the plunger member is less than the diameter of
the tubular
insertion member to allow for a telescopic arrangement of the two.
The tubular insertion member of the applicator provided by the present
invention is preferably substantially closed prior to expulsion of the
materials contained
therein. Alternatively, the insertion end of the applicator can be more or
less open, that
is the diameter along the length of the tubular insertion member is
substantially
equivalent to the diameter of the insertion end. Procter & Gamble, of
Cincinnati, Ohio,
currently offers for sale an open-ended tampon applicator under the trade name
TAMPAX flushable applicator tampons.
In order to facilitate insertion and removal of the applicator 10 from the
body,
we have provided a locking mechanism 30 to secure together the insertion
member and
the plunger for removal. This mechanism includes at least one plunger lock
element 32
and at least one insertion member lock element 34. Each of these lock elements
may be
spaced away from the gripper end of their respective members, e.g., the at
least one
plunger lock element 34 may be located in a central portion of the plunger 24
or even
proximate the insertion end 26 of the plunger 24. Alternately, a preferred
embodiment
positions the at least one plunger lock element 32 proximate the gripper end
28 of the
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plunger 24. Such arrangement would engage at least one insertion member lock
element 34 proximate the gripper end 16 of the insertion member 12.
Useful locking mechanisms may include any one or more of the following:
= A system (Fig. 2) in which the plunger member 24a has a raised ring 32a on
its
outside diameter near the finger grip end 28 with a taper lead 40a that can
move
beyond at least one resilient element, e.g., an elastic member or spring wire
forming a chord within the interior of the insertion member. In more detail,
Fig.
2B shows an insertion member 12a with a locking mechanism 34a in a relaxed
position without the plunger member 24a. Fig. 2C shows an engaged locking
mechanism of this type with insertion member locking mechanism 34a in an
elongated positions distorted by the plunger member 24a after passage of
plunger member locking mechanism 32a.
= A system (Fig. 3) in which the plunger member 24b has a raised ring 32b on
its
outside diameter near the finger grip end 28 with a taper lead 40b that can
move
beyond at least one internal raised ring 34b on the inside surface of the
insertion
member 12b. The interference of the internal and external raised sections
holds
the plunger member 24b and the insertion member 12b together. Of course, the
raised ring with a taper lead may be disposed on an interior surface of the
insertion member with a corresponding ring on an outer surface of the plunger.
= A detent system may also be used.
o In one example shown in Fig. 4, the plunger member 24c has raised,
spring-loaded detent element 32c extending beyond its outside diameter
near the finger grip end 28, and the insertion member 12c has a mating
groove or gap 34c on its inner surface to accommodate the detent
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element 32c. The interference of the spring-loaded detent element 32c
and the groove 34c holds the plunger member 24c and the insertion
member 12c together.
o In other examples shown in Figs. 5 and 6, the plunger member 24 has
one or more protrusion 32e,32f in the form of a ring or point on its outer
surface near the gripper end 28. When assembled the protrusion(s)
32e,32f is capable of interlocking with a corresponding groove 34e,34f
in the inner surface of the insertion member 12 to hold the insertion
member 12 and plunger member 24 together for withdrawal. Such an
arrangement may provide the opportunity to orient an insertable device
18 within the applicator and deliver it to the body cavity in a desired
orientation. In this embodiment shown in Fig. 6A, a raised point 32f
may be rotated to be aligned with a mating depression or void 34f on the
inner surface of the insertion member 12. One or more of these raised
features may have a taper lead surface, e.g., leading surface 40f of the
protrusion 32f that will initially contact the other element of the
interlocking structure to help guide the elements past each other. Fig.
6B shows a cross-section along line B-B of Fig. 6A with a view toward
the gripper end 16 of the insertion member 12. This view shows a
plurality of fins 42 extending from the inner surface of the insertion
member 12 to stabilize the plunger member 24 within the insertion
member 12.
o A similar system shown, e.g., in Figs. 7A-7C, incorporates one or more
raised elements on both the insertion member 12 and plunger member
24. In particular, a plunger member 24g may have a raised ring 32g on
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its outer surface near the gripper end 28 with a tapered lead 40g to move
into and beyond a plurality of internal raised ribs 34g on the inner
surface of the insertion member 12g as shown in Fig. 7A. Alternatively,
the plunger member 24h has a plurality of raised rings 32h on its outer
surface, and the insertion member 12h has a plurality of circumferential
grooves 34h as shown in Fig. 7B. In another variation shown in Fig. 7C,
the insertion member grooves 34h may be replaced with a plurality of
raised rings 34i to interact with the plunger member rings 34i, as
described above (the raised rings of one element would generally be
stable in the gaps between the rings of the interlocking element. Axial
orientation is not necessary for proper function of these embodiments.
While the foregoing have described an element on either the plunger or the
barrel, one of ordinary skill in the art will readily recognize that the
individual interlocking elements may be switched from the plunger to the
barrel and vice versa.
= A resilient outer lip system (Fig. 8) employs a plunger member 24j having an
outer diameter at its gripper end 28 that is larger than that of the gripper
end 16
of the insertion member 12j. However, the outer lip 32j of the plunger member
gripper end 28 has in inner diameter less than the outer diameter of the
insertion
member gripper end 16. Therefore, the plunger member outer lip 32j is
stretched over the insertion member gripper end 16, and the outer lip 32j
engages the outer rim 34j of the insertion member 12j to hold the plunger
member 24j and the insertion member 12j together.
= An interference fit system (Fig. 9) may use a plunger member 24 having a
tapered shaft portion 32k to increase the outside diameter of the plunger
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member 24k as it approaches the plunger member gripper end 28. When the
plunger member 24k is pushed into the insertion member 12, the interference of
the tapered shaft portion 24k of the plunger member 24k and the inside
diameter
34k of the insertion member gripper end 16 to hold the plunger member 24k
and the insertion member 12 together.
= A screw thread system is shown in Fig. 10. The plunger member 24m and the
insertion member 12m have screw threads 32m,34m. Screwing the two
members 12m,24m together holds the plunger member 24m and the insertion
member 12m together.
= Insertion end interlocking systems (Figs. 11 and 12):
o In one embodiment, the plunger member 24n has enlarged diameters at
the insertion end 26n and gripper end 28n. When the plunger member
24n is fully inserted into the insertion member 12, the enlarged insertion
end flange 32n can fit into a recess 34n at the base of the insertion
member petals 20.
o In an alternate embodiment shown in Fig. 12, the plunger member 24o
again has enlarged diameters at the insertion end 26o and gripper end
28o. The plunger member 24o of this embodiment may be longer than
the plunger member 24n of the previous embodiment to allow the
enlarged insertion end flange 32o to extend beyond the insertion
member petals 20 when the plunger member 24o is fully inserted into
the insertion member 12. Once the enlarged plunger insertion end 26o
extends beyond the petals 20, the petals 20 can revert towards their
original, rounded position to hold the plunger member 24o and the
insertion member 12 together.
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= Articulating detent systems:
o In one embodiment shown in Fig. 13, the plunger member 24p is
provided with a plurality of apertures 32p arranged proximate its gripper
end 28. These apertures 32p may be arranged in a variety of patterns,
and in one particular embodiment, they are arranged along a helical path
on the plunger member tube. The insertion member 12p has at least one
flexible detent 34p that extends toward the longitudinal axis of the
insertion member 12p and toward its insertion end 14. As the plunger
member 24p is pushed into the insertion member 12p, the flexible
detent(s) 34p are deflected. If a removal force is applied to the plunger
member 24p, the flexible detent(s) 34p are arranged and configured to
extend into at least one aperture 32p to prevent withdrawal of the
plunger member 24p.
o Hook and Loop (Fig. 14) - The plunger member 24q has a barbed hook
32q on the outer surface near its gripper end 28, and the insertion
member 12q has matching open ring loops 34q. When the plunger
member 24q is pushed into the insertion member 12q the hook 32q
moves past a loop 34q. If the plunger member 24q is pulled out the
hook(s) 32q catch on the loop(s) 43q to prevent withdrawal of the
plunger member 24q.
o Barrel Tang (Fig. 15) - The plunger member 24r has at least one slot 32r
near its gripper end 28. The insertion member 12r has at least one tang
34r that is biased toward the longitudinal axis of the insertion member
12r and toward the insertion end 14. When assembled the unslotted
portion of the plunger member 24r bears against the at least one tang
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34r. However, when the plunger member 24r is used to expel the
insertable device 18 and is fully inserted into the insertion member 12r,
the at least one tang 34r aligns with the at least one slot 32r to permit it
to deploy into the at least slot 32r. This holds the plunger member 24r
and the insertion member 12r together.
o Another embodiment employs a detent and receiving aperture (Fig. 16).
At least one detent 32s extends from the plunger member gripper end
28, generally parallel to the longitudinal axis of the plunger member
24s. The at least one detent 32s has an enlarged transverse dimension
44s distal its attachment to the plunger member gripper end 28. At least
one aperture 34s at the insertion member gripper end 16 is aligned with
the at least one detent 32s and has a transverse dimension 46s arranged
and configured to cooperate with the at least one detent 32s during
complete insertion of the plunger member 24s into the insertion member
12s. The at least one detent 32s and aperture 34s deform to allow the
permit the enlarged transverse dimension 44s to fully enter the at least
one aperture 34s to hold the plunger member 24s and the insertion
member 12s together.
o Toggle (Fig. 17) - The insertion member 12t has a hinged toggle 34t
that pivots into a detent or depression 32t in the plunger member 24t. A
raised portion 48t is spaced from the detent 32t toward the plunger
member insertion end 26 when the plunger member 24t fully inserted
into the insertion member 12t to hold the plunger member 24t in place.
= One piece (Fig. 18) - The insertion member 12u and the plunger member 24u
can be molded together, joined by a thin section 30u as shown in Fig. 18A. As
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the plunger member 24u is inserted into the insertion member 12u, the thin
section 30u stretches and then folds over on itself as shown in Fig. 18B. When
the plunger member 24u is fully inserted into the insertion member 12u, the
stretched thin section 30u straightens and regains a reduced diameter, as
shown
in Fig. 18C. This holds the insertion member 12u and the plunger member 24u
together.
In use, the plunger member 24 is arranged and configured for slidable
movement within the insertion member 12. The locking mechanism 30 includes at
least one plunger lock element 32 and at least one insertion member lock
element 34.
When the plunger and insertion member locking elements 32,34 engage, the user
may
feel the engagement or at least recognize the full engagement of the members
12,24 by
resistance to further movement. This permits a user to determine when the
insertable
device 18 is fully expelled. The locking mechanism 30 also holds the plunger
member
24 fully inside the insertion member 12 to prevent their separation during
removal of
the applicator 10 from the user's body. While specific tube geometry is not
critical, in
order for the locking mechanism 30 to prevent separation of the insertion
member 12
and plunger member 24, a locking mechanism 30 provided at least on a part of
the
insertion member 12 can be created.
Again, the insertion member 12 is sized and configured to house an insertable
element, such as an absorbent tampon 18. The insertion member 12 should have a
substantially smooth exterior surface that will facilitate insertion of the
insertion
member 12 into e.g. a woman's vagina. When the exterior surface is smooth
and/or
slippery, the insertion member 12 will easily slide into a woman's vagina
without
subjecting the internal tissues of the vagina to abrasion. The insertion
member 12 can
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be coated to give it a high slip characteristic. Wax, polyethylene, a
combination of wax
and polyethylene, cellophane, clay, mica and other lubricants are
representative
coatings that can be applied to the insertion member 12 to facilitate
comfortable
insertion.
The applicator of the present invention may be formed by first providing an
insertion member 12 having an insertion end 14 and a gripper end 16. Next, a
plunger
member 24 is provided having an insertion end 26 and a gripper end 28. A
radial
extending protrusion 32 may be formed proximate the plunger member gripper end
28.
In some embodiments, the protrusion 32 may be formed proximate the plunger
member
insertion end 26
The specification and embodiments above are presented to aid in the complete
and non-limiting understanding of the invention disclosed herein. Since many
variations and embodiments of the invention can be made without departing from
its
spirit and scope, the invention resides in the claims hereinafter appended.
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