U.S. patent number 3,791,385 [Application Number 05/297,881] was granted by the patent office on 1974-02-12 for catamenial device and applicator thereof.
Invention is credited to Alwyn K. Davis, Ward A. St. John.
United States Patent |
3,791,385 |
Davis , et al. |
February 12, 1974 |
CATAMENIAL DEVICE AND APPLICATOR THEREOF
Abstract
An expendible menses collector for insertion into the vagina and
comprised of a collapsible monocoque shell of ovular form having a
perforated upper hemisphere and an imperforate lower hemisphere and
within which there is a chamber filled with resilient and absorbent
material. The shell of the device is pliant and supple and has a
circumferential seal at its major diameter that effectively engages
with the vagina wall. Insertion is effected by collapse of the
pliant shell and aided by lubrication released from a frangible or
water soluable cell, and is implemented by a cylinder and piston
applicator.
Inventors: |
Davis; Alwyn K. (Thousand Oaks,
CA), St. John; Ward A. (Newbury Park, CA) |
Family
ID: |
23148104 |
Appl.
No.: |
05/297,881 |
Filed: |
October 16, 1972 |
Current U.S.
Class: |
604/12;
604/285 |
Current CPC
Class: |
A61F
13/2051 (20130101) |
Current International
Class: |
A61F
13/20 (20060101); A61f 013/20 () |
Field of
Search: |
;128/285,270,263 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Primary Examiner: Rosenbaum; Charles F.
Attorney, Agent or Firm: Maxwell; William H.
Claims
I claim:
1. An expendible catamenial device for the collection of menses
discharged into the vaginal vault and adapted to positionably rest
upon the internal border of the peroneal sling, and comprising; a
chambered monocoque shell having a perforated upper hemisphere and
an imperforate lower hemisphere and with a circumferential seal at
the major diameter of the monocoque shell and engageable with the
vagina wall, said shell being made of resiliently pliable material
and thereby adapted to conform to the internal configurations of
the vaginal vault.
2. The catamenial device as set forth in claim 1 wherein the shell
is comprised of said two hemispheres and is ovular in
configuration.
3. The catamenial device as set forth in claim 1 wherein the shell
comprised of said two hemispheres is egg-shaped and the said lower
hemisphere is of larger ovular configuration than said upper
hemisphere.
4. The catamenial device as set forth in claim 1 wherein the
circumferential seal is comprised of at least one continuously
encompassing rib.
5. The catamenial device as set forth in claim 1 wherein the
circumferential seal is comprised of at least one radially flexible
continuously encompassing membranous rib.
6. The catamenial device as set forth in claim 1 wherein the
circumferential seal is comprised of at least one outwardly and
upwardly radially flexible continuously encompassing membranous
rib.
7. The catamenial device as set forth in claim 1 wherein the
circumferential seal is comprised of axially spaced
circumferentially encompassing ribs.
8. The catamenial device as set forth in claim 1 wherein the
circumferential seal is comprised of axially spaced radially
flexible continuously encompassing membranous ribs.
9. The catamenial device as set forth in claim 1 wherein the
circumferential seal is comprised of axially spaced outwardly and
upwardly disposed radially flexible continuously encompassing
ribs.
10. The catamenial device as set forth in claim 1, wherein the
shell comprised of said two hemispheres is egg-shaped and the said
lower hemisphere is of larger ovular configuration than said upper
hemisphere, and wherein the circumferential seal is comprised of
axially spaced outwardly and upwardly disposed radially flexible
continuously encompassing ribs.
11. An expendible catamenial device for the collection of menses
discharged into the vaginal vault and adapted to positionably rest
upon the internal border of the peroneal sling, and comprising; a
chambered monocoque shell having a perforated upper hemisphere and
an imperforate lower hemisphere and with a circumferential seal at
the major diameter of the monocoque shell and engageable with the
vagina wall, and resiliently collapsible fill of absorbent material
occupying the chambered shell, said shell being made of resiliently
pliable material and thereby adapted to collapse around said fill
and to be subsequently expanded thereby into its initial aforesaid
form.
12. The catamenial device as set forth in claim 11, wherein the
resiliently collapsible fill is fiberous material.
13. The catamenial device as set forth in claim 11 wherein the
resiliently collapsible fill is a cellular body.
14. An expendible catamenial device for the collection of menses
discharged into the vaginal vault and adapted to positionably rest
upon the internal border of the peroneal sling, and comprising; a
chambered monocoque shell having a perforated upper hemisphere and
an imperforate lower hemisphere and with a circumferential seal at
the major diameter of the monocoque shell and engageable with the
vagina wall, an extraction means therefor including a lanyard
depending from said lower hemisphere and exposed at the exterior
opening of the vagina, said shell being made of resiliently pliable
material and thereby adapted to collapse and subsequently expand
into its initial aforesaid form.
15. The catamenial device as set forth in claim 14 wherein the
extraction means is a normally closed tubular valve means opening
into the vaginal vault and open to atmosphere at the opening of the
vagina.
16. The catamenial device as set forth in claim 14 wherein the
lanyard is a tube opening into the vaginal vault and normally
closed by a removeable button manually disengageable to open the
tube to atmosphere at the opening of the vagina.
17. The catamenial device as set forth in claim 14 wherein the
lanyard is a loop of tubing opening into the vaginal vault and
normally closed by a removeable button manually disengageable to
open the tube to atmosphere at the opening of the vagina.
18. The catamenial device as set forth in claim 14 wherein the
lanyard of the extraction means is a tube slideably engaged with a
valve member carried by the shell and moveable relative to the
shell to be disengaged from said valve member and opened to
atmosphere at the opening of the vagina.
19. The catamenial device as set forth in claim 14 wherein the
lanyard of the extraction means is a tube slideably engaged with a
valve member carried by the upper hemisphere of the shell and
moveable through the lower hemisphere of the shell to be disengaged
from said valve member and opened to atmosphere at the opening of
the vagina.
20. The catamenial device as set forth in claim 14 wherein the
lanyard of the extraction means is a tube slideably engaged with a
valve member carried by the upper hemisphere of the shell and
frictionally engaged with and moveable through the lower hemisphere
of the shell to be disengaged from said valve member and opened to
atmosphere at the opening of the vagina.
21. The catamenial device as set forth in claim 14 wherein the
lanyard of the extraction means is a tube slideably engaged with a
valve member carried by the upper hemisphere of the shell and
frictionally engaged with and moveable through the lower hemisphere
of the shell and having a stop limiting said movement and for
disengagement from said valve member and opened to atmosphere at
the opening of the vagina.
22. An expendible catamenial device for the collection of menses
discharged into the vaginal vault and adapted to positionably rest
upon the internal border of the peroneal sling, and comprising; a
chambered monocoque shell having a perforated upper hemisphere and
an imperforate lower hemisphere and with a circumferential seal at
the major diameter of the monocoque shell and engageable with the
vagina wall, resiliently collapsible fill of absorbent material
occupying the chambered shell, and extraction means therefor
including a lanyard in the form of a tubular valve controlled
element extending through said collapsible fill and depending from
said lower hemisphere and exposed at the opening of the vagina,
said shell being made of resiliently pliable material and thereby
adapted to collapse around said fill and to be subsequently
expanded thereby into its initial aforesaid form.
23. The catamenial device as set forth in claim 22 wherein the
extraction means is a normally closed tubular valve means opening
into the vaginal vault and open to atmosphere at the opening of the
vagina.
24. The catamenial device as set forth in claim 22 wherein the
lanyard is a tube opening into the vaginal vault and normally
closed by a removeable button manually disengageable to open the
tube to atmosphere at the opening of the vagina.
25. The catamenial device as set forth in claim 22 wherein the
lanyard is a loop of tubing opening into the vaginal vault and
normally closed by a removeable button manually disengageable to
open the tube to atmosphere at the opening of the vagina.
26. The catamenial device as set forth in claim 22 wherein the
lanyard of the extraction means is a tube slideably engaged with a
valve member carried by the shell and moveable relative to the
shell to be disengaged from said valve member and opened to
atmosphere at the opening of the vagina.
27. The catamenial device as set forth in claim 22 wherein the
lanyard of the extraction means is a tube slideably engaged with a
valve member carried by the upper hemisphere of the shell and
moveable through the lower hemisphere of the shell to be disengaged
from said valve member and opened to atmosphere at the opening of
the vagina.
28. The catamenial device as set forth in claim 22 wherein the
lanyard of the extraction means is a tube slideably engaged with a
valve member carried by the upper hemisphere of the shell and
frictionally engaged with and moveable through the lower hemisphere
of the shell to be disengaged from said valve member and opened to
atmosphere at the opening of the vagina.
29. The catamenial device as set forth in claim 22 wherein the
lanyard of the extraction means is a tube slideably engaged with a
valve member carried by the upper hemisphere of the shell and
frictionally engaged with and moveable through the lower hemisphere
of the shell and having a stop limiting said movement and for
disengagement from said valve member and opened to atmosphere at
the opening of the vagina.
30. An expendible catamenial device for the collection of menses
discharged into the vaginal vault and adapted to positionably rest
upon the internal border of the peroneal sling, and comprising; a
chambered monocoque shell having a perforated upper hemisphere and
an imperforate lower hemisphere and with a circumferential seal at
the major diameter of the monocoque shell and engageable with the
vagina wall, said shell being made of resilient pliable material
folded bilaterally in one plane and then rolled into a minimum
cross sectional collapsed configuration and thereby adapted to be
subsequently expanded into its initial aforesaid form.
31. The catamenial device as set forth in claim 30 wherein the
chambered shell is filled with resiliently compressible absorbent
material.
32. The catamenial device as set forth in claim 30 wherein the
chambered shell is attached to a tubular lanyard and normally
closed valve means open to atmosphere and operable to open
therethrough and into the innermost portion of the vagina.
33. The catamenial device as set forth in claim 30, wherein the
chambered shell is filled with resilient compressible absorbent
material, and wherein the lower hemisphere is attached to a tubular
lanyard and normally closed valve means extended through said
absorbent material and open to atmosphere and operable to open
therethrough and into the innermost portion of the vagina.
34. A catamenial device and applicator therefor for the collection
of menses discharged into the vaginal vault and adapted to be
positionably rested upon the internal border of the peroneal sling,
and comprising; a chambered monocoque shell having a perforated
upper hemisphere and an imperforate lower hemisphere and with a
circumferential seal at the major diameter of the monocoque shell
and engageable with the vagina wall, said shell being made of
resiliently pliable material folded bilaterally into one plane and
then rolled into a minimum cross sectional collapsed configuration
and confined within an open ended tube from which it is
subsequently projected and expanded into its initial aforesaid
form.
35. The catamenial device as set forth in claim 34 wherein the
curvilinear uppermost crown of the upper hemisphere projects from
said open ended tube.
36. The catamenial device as set forth in claim 34 wherein the open
ended tube is closed by a cap.
37. The catamenial device as set forth in claim 34 wherein the open
ended tube is closed by a tapered curvilinear cap.
38. The catamenial device as set forth in claim 34 wherein the open
ended tube is closed by a tapered curvilinear and frangible cell
containing lubricant.
39. The catamenial device as set forth in claim 34 wherein the
curvilinear uppermost crown of the upper hemisphere projects from
said open ended tube and is covered by a tapered curvilinear
peel-off element exposing lubricant.
Description
BACKGROUND
With reference particularly to man, the female of the species
performs its reproductive cycle through a usual 28 day or monthly
period, during which there is a continual change in the
reproductive organs. Briefly, the female ovulates whereupon the
ovum eminates from the ovary and escapes into the fallopian tube
and progresses to the uterus which has been preparing therefor by
maturation of the endometrial lining of the uterus. Only in the
event that the ovum is impregnated does it attach to the uterus
wall and form into a fetus, and when not impregnated the
endometrial lining of the uterus sloughs away and is discharged
through the cervix into the vagina or birth canal. This discharge
period or menstrual portion of the reproductive cycle produces
therefore the discharge known as menses and which is composed of
degenerating endometrical tissue, body fluids, and varying amounts
of blood. And, although the cervix opening of the uterus into the
vagina experiences changes in the premenstrual, menstrual and
post-menstrual periods, the vagina retains its general
configuration and can be relied upon for the retension of devices
such as is disclosed herein, and namely a device for the
containment and control of the menses as is normally
discharged.
The vagina or birth canal is that reproductive organ which is the
squamous mucus membrane canal that extends into the body from the
vulva, into which the cervix of the uterus is open, and through
which the menses normally flows. This organ is supported by and
passes through the peroneal sling and will take a variety of
positions in different individuals, but in any case is normally of
tubular formation with an inner wall that has folds or the like
which permit it to close together and as well to expand. The
expanded diameter of the vagina is the least at the introitus near
the vulva and hymen area, while it is the greatest at the upper
vaginal vault or closed remote end where the cervix enters therein.
Further, there is an internal border of shoulder of the pelvic
peroneal sling which is superior to the introitus and which is
comprised primarily of the following muscles with their facia and
supporting structures; namely the pubococcygeus, levator ani,
transverse parinaei and bulbo-cavernosus muscles. It is this
muscular border or shoulder which forms the support upon which the
device of the present invention will rest, and it is a general
object of this invention to advantageously employ the
aforementioned shoulder to the purpose of retaining the catamenial
device in working position as shown herein.
FIELD OF INVENTION
The vagina establishes a yieldingly contractible passage through
which the menses is free to discharge, and the introitus and said
shoulder portion is determinably measurable in practically all
individuals. This muscular border or shoulder is located internal
to the peroneal sling and is comfortably expansible to an
approximate diameter of 11/2 inches (3.7 cm) in the average
individual; while the extreme expansibility is from about
three-quarters of an inch (2 cm) to 2 inches (5 cm). Therefore, it
is an object of this invention to provide a menses collecting
device adapted to be positioned proximal to and carried by the said
muscular border or shoulder within the canal of the vagina while
expanding the organ comfortably inside the confines of the peroneal
sling. The nominal size or diameter of this device is determined by
the measured expansibility in the individual, and in practice the
device is to be furnished in several nominal sizes.
The comfort and safety of the individual is of prime importance and
it is to this end that the shape and construction material of this
device is important. It is an object therefore, to provide a device
compatible with and having substantially the same suppleness as the
membrane of the in vivo organ in which it is contained. With the
present invention, a thin walled device of supple and pliant
plastic is provided of a material that is inert or neutral with
respect to the in vivo environment in which it is useably
contained.
It is another object of this invention to provide a readily
insertable device of the type herein referred to, and a device that
is collapsible and easily passed through the vulva and restricted
introitus and smaller outlet diameter portion of the vagina. With
the present invention, advantage is taken of the sizeable volume of
the vaginal vault, namely the large diameter portion thereof into
which the cervix of the uterus discharges. Accordingly, it is still
another object of this invention to provide a device that is
expansible to a maximum volume and adapted to collect a substantial
quantity of menses.
The catamenial device of the present invention is a chambered
structure that is collapsible and which contains a compressively
expansible charge of absorbent fill. The aforementioned supple
walls of plastic material are formed in upper and lower
hemispheres, the former being perforated and the latter being
imperforate. The fill is contained therein, and the major diameter
intermediate the two hemispheres is provided with seals that assure
containment of fluids within the confines of the vagina.
Accordingly, it is an object to provide a device having the
practical features of such description, a comfortable device devoid
of sharp edges and corners, a device which will retain the menses
inherently entered therein, and a device that reliably seals with
the vagina walls.
It is still another object of this invention to provide means for
breaking the partial vacuum created during retraction of such a
device from its sealed confinement within the vagina of an
individual. Having provided an effective seal with the vagina wall,
the present invention includes a valve openable to atmosphere and
communicating into the innermost and largest portion of the vagina.
Further, this precludes abnormal suction which otherwise might be
applied to the upper vaginal vault and through the cervix and into
the uterus; and all of which would hamper removal of the
device.
It is also an object of this invention to eliminate direct contact
between the mucus membrane and the absorbent fill material that
collects the menses. With the present invention the device is
essentially a chambered monocoque shell with a perforated
hemisphere through which the discharged menses is enterable. The
absorbent fill is confined within the shell and out of contact with
the mucus membrane of the vagina and cervix, while the said shell
has sufficient rigidity to maintain its initially formed expanded
shape with interfacial engagement with said mucus membrane walls of
the vagina. Further, the expanded shape of this device is
advantageously employed as a pessary in instances where support of
the uterus, bladder and rectal walls is required, in which case the
resiliently filled monocoque shell provides a cushioned support for
these organs. The fill which is characterized by a multiplicity of
resilient fibers will not dry the vaginal muscosis or adhere to the
vagina walls. And, concurrent with the advantages of this
structure, it is also an object of this invention to expose a
lubricant as by means of removing a cap, breaking a frangible cell,
or a water soluable cell.
DRAWINGS
The various objects and features of this invention will be fully
understood from the following detailed description of the typical
preferred forms and applications thereof, throughout which
description reference is made to the accompanying drawings, in
which:
FIG. 1 is a sectional view taken through the central plane of the
female anatomy, showing the device of the present invention
installed therein.
FIG. 2 is a transverse section of the said female anatomy.
FIG. 3 is an enlarged sectional view of the device in its preferred
embodiment.
FIG. 4 is a view similar to FIG. 3 showing a second embodiment of
the device.
FIG. 5 is a fragmentary enlarged section showing the valve means of
FIG. 3 and its operation.
FIG. 6 is an elevation showing the applicator for the device as it
is stored therein. And,
FIGS. 7 and 8 are illustrative of the mode in which the device is
folded for insertion into the said applicator.
PREFERRED EMBODIMENT
The catamenial device herein disclosed overcomes the usual
objections to other devices of the type under consideration.
Realizing that the upper vaginal vault of the vagina is expansible
to quite a large volume, whereas the introitus into the vagina
tends to be constricted, the collapsible and subsequently
expansible device herein disclosed is advantageously employed to
occupy that enlarged portion of the vagina into which the menses is
discharged. Unobviously, the support for carrying this device in
working position is the muscular border or shoulder which occurs
near the outlet portion of the vagina and said upper vault thereof,
this shoulder being upwardly disposed and thereby adapted to
establish support. Further, the walls of the vagina fold together
and are yieldingly expansible and to the end that the mean diameter
at said shoulder is flexible. Also, a factor is the introduction
and intrusion of a sizeable device through the introitus and
through the orifice of the peroneal sling, and all of which is
enhanced by the instant device which is characterized by its
curvilinear entry portion especially adapted to ease penetration
into the body.
Referring now to the drawings, the body cross sections of FIGS. 1
and 2 show the installation of the expansible menses collector
supported upon the upwardly disposed muscular border or shoulder
which normally occurs between the introitus and upper vaginal
vault. The expanded device is of rounded configuration and
preferably of ovular form comprised generally of a chambered shell
having a perforated upper hemisphere X, an imperforate lower
hemisphere Y, an intermediate seal Z, an absorbent fill F,
lubricating means L, and a valve means V. The shell S is a
monocoque structure of pliant but suitably stiff material that has
sufficient memory to return to its initial shape. The two
hemispheres X and Y which form the shell are permanently secured
together with the absorbent fill F contained therein. The
lubricating means L is a frangible or water soluable cell or
peal-off element strategically located and which facilitates
insertion of the device into working position. And, the valve means
V is operable to release atmospheric pressure into the upper
vaginal vault so as to facilitate removal of the device.
The chambered shell S is a thin walled member of pliant material
and is of rounded ball form. In accordance with the invention, the
ball form of the shell is elongated on its major axis which extends
coincidental with the columnar axis of the vagina, and thus the
shell S is ovular and egg-shaped. As a practical matter, the shell
is fabricated in halves which are joined permanently together at
the major diameter mid-cross section of the member. The wall of the
shell is a self-supporting monocoque structure of pliant and supple
material which is collapsible and yet sufficiently stiff and
resilient in order to return to its initial formation, or to the
general configuration of the individual vaginal vault in which it
is contained. A suitable material is rubber or a plastic substitute
therefor which is deformably pliable and adapted to return to these
configurations after prolonged collapse. Further, the physical
properties of such material closely resemble the soft nature of the
vagina wall, but necessarily the material of the shell S is
substantially harder than the said body tissues, and all to the end
that the normal constrictive forces applied by the vagina through
the full range of body movements will not collapse the device when
in use. However, it is to be understood that there is a suitable
flexibility in the device which permits it to deform in
configuration and in conformity to the changes in shape which take
place in the vagina during the various expected body movements, and
to the individual differences in vaginal configurations.
The upper hemisphere X of the chambered shell S is a tapered
curvilinear dome and is perforated as shown for the reception of
the menses discharged into the vagina. The channeling of discharge
from the cervix is at random and to this end the entire upper
surface of the shell S and upper hemisphere X is perforated and/or
of screen form, thereby permitting entry of fluids into the
chambered interior of the shell.
The lower hemisphere Y of the chambered shell S is semi-spherical
and imperforate for the retension of the menses discharge collected
therein from the upper hemisphere X. The hemisphere Y is
essentially, therefore, a vessel or basin which contains the
discharged fluids that collect therein.
The intermediate seal Z that engages the vagina wall prevents
discharge of the menses to the body exterior and is a wing-like
structure that projects radially from the peripheral major diameter
of the shell S and is preferably in the form of a plurality of
encompassing ribs 10 that extend outwardly and upwardly to
circumferentially continuous lips 11 respectively. These ribs 10
are of relatively thin cross section and are thereby membranous and
of flexible nature, being integrally formed of the aforementioned
plastic material and adapted to conform to all irregularities
substantially without leakage. As shown, the multiple lips are
spaced and together establish a labyrinth which supplements and
enhances the seal.
The absorbent fill F that is contained within the chambered shell
can vary widely. For example, it can be a cellular sponge or it can
be a collection of spaced fibers. In either case, the fill F is a
collapsible body that is resilient and adapted to expand into full
occupancy within the chamber shell S when said shell expands into
full form. In practice, resilient fibers are employed and into
which the discharged body of fluids are readily absorbed. It is to
be understood that the density of said fibers is established by the
particular physical properties thereof and their ability to retain
the said body fluids therebetween.
The valve means V that is operable to release atmospheric pressure
into the upper vaginal vault is a normally closed valve which is
releasable as and when required in order to facilitate removal of
the device from working position. As is shown, the shell S of the
device is expanded and rests upon the aforementioned muscular
border or shoulder formed by the peroneal sling. Furthermore, the
intermediate seal Z effectively isolates the innermost vaginal
vault from the introitus thereof which opens to atmosphere. Thus,
when extraction force or movement is applied there would be a
consequent suction or partial vacuum applied within the said
innermost vault and which opens through the cervix and into the
uterus that communicates to the fallopian tubes and lower abdomen.
Application of such a negative pressurization could be
discomforting or injurious, and as well cause mechanical difficulty
in removal of the device.
Accordingly, therefore, an extracting means E is provided in the
form of a lanyard 20 that depends from the lower hemisphere Y of
the shell and said lanyard is tubular for transmission of fluid
(air) therethrough. In its preferred form, valve means V is
normally closed and releasable to open at the top of the upper
hemisphere X, and therefore it extends through the chamber within
the shell S. As shown in FIGS. 1-3 and 5, the lanyard 20 is a
depending loop 25 that fairs tangentially into the opposite inner
walls of the lower hemisphere Y; and the valve element V is a plug
or button 26 at its lowermost extremity and which is ripped off
manually when required. As shown in FIGS. 4, 6 and 8, the valve
element is a stem 21 that depends axially from the interior side of
the upper hemisphere X and slideably (slip-fit) engages in the
otherwise open end of the lanyard 20, forming a plug. The lanyard
20 projects axially through the lower hemisphere Y where it
frictionally (press-fit) engages in an opening therethrough. A stop
22 projects laterally from the lanyard normally spaced above the
interior side of the lower hemisphere Y and said stop engages said
interior side when the upper terminal end of the lanyard is pulled
free of the valve stem 21. In practice, a finger loop 23 is
provided at the lower end of the lanyard and which is engageable
(also the loop 25) to apply downward force and movement for both
seating of and extraction of the device from the vagina. As is
clearly indicated, the lowermost terminal end of the tubular
lanyard is open to atmosphere. Like the shell of the device, the
tubular lanyard 20 (and 25) is made of soft pliable material so as
to be conveniently trained into a conveniently obscure position
during use.
An applicating means A is provided in the form of an open ended
cylinder 30 through which a piston 31 is manually operable to press
the collapsed shell S therefrom. Such applicators are common and a
description thereof is quite unnecessary, however the disposition
and configuration of the shell S is quite unique and cooperatively
combined with the cylinder 30 for its practical application and
insertion into a working position. In other words, the collapse,
initial projection and subsequent expansion of the shell S is
practical and readily accomplished by virtue of foldability of the
supple shell and its fill as will now be described: Firstly, the
ovular shell S of egg-shape is collapsed laterally (see FIG. 7) so
as to fold in a substantially vertical plane with one side half
thereof bilaterally depressed into the other side half thereof.
Secondly, the bilaterally collapsed shell S is rolled
circumferentially (see FIG. 8) so as to minimize its cross section.
And thirdly, the folded and rolled shell S is slideably entered
into and stored within the confines of the open ended tubular
cylinder 30 as shown in FIG. 6 with its tapered curvilinear
foremost end exposed for ease of penetration. The aforesaid
collapse results in the compression of the fill F of resilient
fibers which subsequently expand to open the shell S toward its
initially formed monocoque shape. Reversely therefore, the shell
walls then unfold under the expansive influence of the resilient
fill from which the confining pressure has been released, and
thereafter the shell S seeks its full pre-form as shown installed
in FIGS. 1 and 2 herein.
The lubricating means L that facilitates insertion of the device is
a peel-off element, or frangible or water soluable cell that
exposes or releases a lubricant as and when so required. As shown,
the orientation of shell S is on its major longitudinal axis of
insertion coincidental with the columnar axis of the vagina.
Therefore, the tapered and curvilinear upper hemisphere X is
foremost and initiates entry into and through the vulva; and in
accordance with this invention the lubricating means L is located
strategically over the forward apex (when folded) or curvature of
said upper hemisphere. As shown, the peel-off element or frangible
and/or soluable cell is in the form of a cap 50 carried over the
otherwise open end of cylinder 30 to protectively cover the tapered
curvilinear end portion of the device which exposedly projects
therefrom. In practice, the protective peel-off element can be
removed in its entirety and said frangibility thereof can be
enhanced and/or controlled by forming the cell walls of a water
soluable material that is substantially weakened when placed into
contact with water or body fluids. The lubricant to be exposed can
vary as circumstances require and for example can be a form of
petroleum jelly, water soluable jelly, or the like.
Having described only typical preferred forms and applications of
our invention, we do not wish to be limited or restricted to the
specific details herein set forth, but wish to reserve to ourselves
any modifications or variations that may appear to those skilled in
the art:
* * * * *