U.S. patent number 3,815,600 [Application Number 05/274,263] was granted by the patent office on 1974-06-11 for vaginal medicator.
Invention is credited to Harvey H. Groves.
United States Patent |
3,815,600 |
Groves |
June 11, 1974 |
VAGINAL MEDICATOR
Abstract
A vaginal medicator adapted to be retained within the human
vaginal canal to apply medication molded thereon to the vaginal
canal and cervix including body-undissolvable stem and anchor
means. The stem is formed into various shapes and lengths, each
designed to reach along the length of the vaginal canal from its
lower end to the region of the cervix thus enabling medication
molded thereto to be delivered where desired within the vaginal
canal. The stem may include loops, webs and meshes for carrying
additional medicaments and for increasing the application of
medicaments to the cervix. The anchoring means may be a spherical,
ellipsoidal or cylindrical mass connected at one end of the stem
adapted to hold the medicator in proper position by virtue of the
constricting muscles at the entrance to the vaginal canal.
Alternatively, the structure of the stem itself, such as a
substantially triangular looped stem or a stem having a cervix
surrounding loop at its inner end may adequately serve as the
anchoring means.
Inventors: |
Groves; Harvey H. (Westport,
CT) |
Family
ID: |
23047490 |
Appl.
No.: |
05/274,263 |
Filed: |
July 24, 1972 |
Current U.S.
Class: |
604/286 |
Current CPC
Class: |
A61M
31/002 (20130101) |
Current International
Class: |
A61M
31/00 (20060101); A61f 013/20 (); A61m
031/00 () |
Field of
Search: |
;128/232,27X,271,285X |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Medbery; Aldrich F.
Attorney, Agent or Firm: Wooster, Davis & Cifelli
Claims
What I claim is:
1. A vaginal medicator comprising:
elongated body-undissolvable stem means for extending along
substantially the entire length of the vaginal canal to the region
of the cervix;
a body-undissolvable anchoring mass connected to one end of said
stem means, said anchoring mass being of a size to be retained
above the constricting muscles at the entrance to the vaginal canal
with at least a portion of the stem means extending upwardly from
said anchoring mass to be positioned in the upper portion of the
vaginal canal and near the cervix;
medication carried by said stem means for slowly dissolving in the
vaginal canal to supply medication thereto; and
pullout means connected to said anchoring mass and extending out
from the vaginal canal when the medicator is in place therein for
providing easy removal of the medicator.
2. The medicator of claim 1 wherein said anchoring mass is
spherical.
3. The medicator of claim 1 wherein said anchoring mass is
cylindrical.
4. The medicator of claim 1 wherein said anchoring mass is formed
from cotton.
5. The medicator of claim 1 wherein said anchoring mass is formed
from plastic.
6. The medicator of claim 1 wherein said anchoring mass is hollow,
is formed from a drug-permeable material and contains medication
therein which is slowly released to the vaginal canal.
7. The medicator of claim 6 wherein said stem means is a hollow
tube-like member formed from a drug-permeable material, said hollow
member opening to said hollow anchoring mass to form a continuous
core through the medicator.
8. The medicator of claim 1 wherein said stem means is a thin
flexible stem and said medication is in the form of a
body-dissolvable moldable solid surrounding said stem.
9. The medicator of claim 8 wherein said pullout means is a thin
flexible member surrounded by said medication.
10. The medicator of claim 1 wherein said stem means is a hollow
tube-like member formed from a drug-permeable material and said
medication is carried therein.
11. The medicator of claim 1 wherein said elongated stem is a thin
flexible stem with a blunt inner end, and said medication is in the
form of a body-dissolvable moldable solid surrounding said stem and
said blunt end.
12. The medicator of claim 11 wherein said medication is formed
into an enlarged bulb around said blunt end.
13. The medicator of claim 1 wherein said stem means includes web
means extending laterally therefrom, on which medication may be
adhered.
14. The medicator of claim 1 wherein said stem means is
approximately 3 to 4 inches in length.
Description
BACKGROUND OF THE INVENTION
The present invention relates to medicators and, more particularly,
to vaginal medicators or suppositories. One of the principal
requirements for applying topical medication to the body is that
the medication remain in the desired body area for an extended
period of time. For example, in the treatment of vaginal disease,
it is desirable that the medication be applied for many hours to
remote regions of the vaginal canal and cervix. These regions are
not readily reached by conventional vaginal suppositories due to
their size and shape. Due to the structure and nature of the human
vigina, for example, inserted suppositories or ovules often do not
stay in place, or upon melting, the medication may drain out of the
vagina, substantially reducing its effectiveness. In either of
these cases, the medication is not maintained in the desired
location for a sufficient duration of time, nor does it necessarily
find its way to affected parts in the vaginal canal which are
remote from the normal positioning of suppositories.
Prior attempts at overcoming these problems have not been
satisfactory. For example, presently available medicated cotton
tampons do not extend along the length of the vaginal canal and,
therefore, cannot deliver medication where desired. Furthermore,
they do not allow for efficient transfer of medication to affected
areas, nor can they be used to apply medication to selected areas
because of the highly absorbent nature of the cotton fibers. Other
medicators are uncomfortable to insert and use because of their
rigid structure.
SUMMARY OF THE INVENTION
These problems and disadvantages are overcome by the present
invention by providing a medicator which extends along the entire
length of the vaginal canal to the cervix so that medication may be
delivered wherever desired and which provides efficient transfer of
medication and is comfortable to use. More specifically, the
present invention includes a flexible or semirigid
body-undissolvable stem of plastic or other suitable material
formed into various shapes which extends along the entire length of
the vaginal canal reaching to the cervix. Medication molded to the
stem or any portion thereof can be maintained for extended periods
of time in any position desired, depending upon where it is molded
to the stem. The medicator is held in place by virtue of the action
of the constricting muscles at the lower region of the vaginal
canal and the anchoring means of the medicator. The anchoring means
may be provided by a mass of body-undissolvable plastic or other
suitable material secured to one end of the stem. This mass, which
is preferably spherical, ellipsoidal or cylindrical, is dimensioned
so as to be retained comfortably in the vagina by the constricting
muscles near the entrance of the vagina. Alternatively, the
anchoring means may be provided by the configuration of the stem in
relation to the anatomy of the vaginal tract. Such configurations
include loops to encircle or partially surround the cervix,
cup-shaped webs attached to the stem and designed to fit over the
cervix and the generally triangular shape of the looped stem which
resolves the lateral forces from the constricting muscles and the
naturally collapsing walls of the vagina into longitudinal forces
serving to urge the medicator upwardly into the vaginal canal.
It is, therefore, a general object of the present invention to
provide a vaginal medicator which overcomes the disadvantages of
the prior art.
It is a more specific object of the present invention to provide a
vaginal medicator which can deliver medication to the entire
vaginal canal and the cervix or any portion thereof for extended
periods of time.
It is another object of the present invention to provide a vaginal
medicator which may be comfortably retained within the vaginal
canal for extended periods of time.
It is still another object of the present invention to provide a
vaginal medicator which may be maintained in a desired position
within the vaginal canal.
It is a further object of the present invention to provide a
vaginal medicator which provides for efficient transfer of
medication to the affected areas.
BRIEF DESCRIPTION OF THE DRAWINGS
These as well as other objects and advantages will be readily
apparent to those skilled in the art from a perusual of the
appended claims and the following description when read in
conjunction with the attached drawings in which:
FIGS. 1a-b are illustrations of a first embodiment of the present
invention without and with medication applied, respectively.
FIG. 2 is an illustration of a modified version thereof with a
cylindrical anchor.
FIG. 3 is an illustration of another modified version thereof with
a hollow drug-permeable stem and anchor.
FIG. 4 is an illustration thereof with additional medication
provided at the inner end thereof and along the pullout string.
FIG. 5 is an illustration of a modified version thereof in which a
second body-undissolvable bulb is included at the inner end.
FIG. 6 is an illustration of a modified version thereof in which
the stem includes a laterally extended web or mesh to increase the
surface area and amount of medication.
FIGS. 7a-e are illustrations of various modified versions of a
second embodiment of the present invention in which the stem is
formed in a substantially triangular configuration with a cervix
engaging loop.
FIG. 8 is an illustration of a modified version of the FIG. 7a
medicator in which a mesh extends within the area enclosed by the
stem to increase the surface area and amount of medication.
FIGS. 9a-b are illustrations of two versions of a third embodiment
of the present invention in which the inner end of the stem
terminates in a cervix engaging loop and cup, respectively.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
Three embodiments of the present invention will now be described,
as well as various modifications which may be incorporated in each.
Although some of the modifications are described in conjunction
with only one embodiment, it will readily be apparent that many of
them may be incorporated in other embodiments as well.
Now, with particular reference to FIGS. 1 - 6, a first embodiment
of the vaginal medicator, generally designated 10, will be
described. The medicator 10 includes a flexible or semirigid stem
12 formed from a body-undissolvable plastic material, a fiber
thread, or other suitable material. The stem 12 is secured to an
anchor 14 which may be formed from cotton, fibrous material,
plastic or other suitable material. A pullout string 16 is attached
to the anchor 14 for purposes of manually removing the device after
use. This pullout string 16 may be separately attached to the
anchor 14 or may be an integral extension of the stem 12.
The anchor 14 is preferably either spherical (14) as shown in FIGS.
1a and 1b, cylindrical (14') as shown in FIG. 2 or ellipsoidal (not
shown). If the anchor 14 is to be made of cotton it may be formed
by spinning cotton onto the end of the stem 12; and may be bound to
itself through impregnation of the cotton with waxes, resins,
sizing compounds, latexes, etc., and subsequently coated with a
resin or other materials similar to those indicated above to
provide a nonabsorbent surface, or partially absorbent surface as
may be desired. The anchor 14 may also be fastened to the stem by
using bonding cement or by heat-plasticising the end of the stem
12. The anchor 14 also may be formed by means other than by
spinning, for example by sewing together cotton wads and
subsequently attaching them to the stem. Alternatively, the anchor
can take the form of a conventional tampon of shortened length and
sewn or otherwise secured to the end of the stem 12. If the anchor
14 is cotton, it may be designed to expand after insertion while
also increasing its absorbency, if so desired, by not applying
sizing, bonding, or coating compounds and/or by containing the
naturally expansive fibers within a hollow applicator similar to
that used to insert conventional vaginal tampons, so that expansion
takes place after insertion of the device and subsequent removal of
the applicator. If the anchor 14 is plastic, it may be attached to
the stem 12 by cement or by means of heat, sonic, or high frequency
welding or other methods. In addition to the modes of attachment
previously described the stem 12 and anchor 14 may also be formed
from a unitary, continuous piece of plastic such as by injection
molding.
The inner end of the stem, that is the end remote from the anchor
14 may be provided with a blunt end 18 by spinning a small amount
of cotton or other fiber to guard against possible abrasion of body
tissues after the medication has been dissolved away. The blunt end
18 may also be provided by dip-coating the inner end of the stem 12
into plastic melts or by bonding a pre-molded bulb of
body-undissolvable material such as plastic to the end of the stem
12. This bulb may be a small blunt tip 18 or a somewhat larger bulb
20 as shown in FIG. 5.
The anchor 14 and the stem 12 may vary in size depending upon the
size of the human in which they are to be used. The stem must be
long enough to reach to the upper most extremities of the vaginal
canal to the region of the anterior or posterior fornices when the
anchor is in position in the lower part of the vaginal canal in the
same general region occupied by conventional vaginal tampons. For
the typical adult human, the stem may be approximately 1/32 to 1/16
inch in diameter and 3 to 4 inches in length, and the anchor may be
approximately 3/4 inch in diameter.
A medication 22 shown in partial cross section surrounding the stem
12 in FIGS. 1b, 2 and 4 may contain medicaments, drugs, etc.
designed for local and/or systemic effects, which may or may not be
absorbed by the vaginal mucosa, suspended in a pharmaceutical base
designed to melt slowly over a period of hours as a result of the
temperature of the body or to dissolve slowly as a result of
contact with body fluids. Examples of suitable pharmaceutical bases
include polyethylene glycols, glycerogelatins, gelatins, waxes,
modified fats and fatty oils. The cross-sectional diameter of the
stem 12 and surrounding medication 22 may be approximately 1/4 inch
to 3/8 inch and is considerably less than the diameter of the
anchor 14. If desired, an increased amount of the medication 22 may
be formed at or adjacent the blunt end 18 of the stem 12, such as
at 24 (FIG. 4). This provides an increased amount of medication to
the cervix and upper portion of the vaginal canal. Additionally,
the medication 26 may also be provided around the pullout string 16
to deliver medication to the extreme lower portion of the vaginal
canal.
The embodiment of the vaginal medicator 10 as thus far described
may also be modified by making either or both the anchor 14 and the
enlarged bulb 20 hollow and drug-permeable so that additional
medication may be stored therein to slowly migrate through its
walls into the surrounding vaginal tissues when subjected to body
temperature or when in contact with body fluids. As meant herein,
drug-permeable includes any material through which a medication can
pass, such as a drug-permeable plastic or a perforated plastic.
These modifications are shown in FIG. 5 with the anchor 14" and the
enlarged bulb 20 being made of drug-permeable material and
containing additional medication 28. The enlarged bulb 20 whether
hollow and containing medication or not gives additional anchoring
to the suppository by being located in the vault of the vagina near
the cervix. It also may be used to provide additional medication to
the area near the cervix by being drug-permeable and containing
medication or by surrounding a solid bulb with medication.
In the same manner, the entire medicator 10 may be hollow and
formed from a drug-permeable material as shown in FIG. 3. The stem
12 is integral with the anchor 14'" to form a continuous hollow
core which may be filled with medication. In this arrangement the
stem 12' will be approximately the same dimensions as the stem 12
with medication 22 thereon.
This embodiment of the vaginal medicator 10 may be modified as
shown in FIG. 6 to include a mesh or web 30 to which medication may
be adhered. Although, as shown, the web 30 extends along the entire
length of the stem 12 it should be understood that the web 30 could
be designed to extend along only a portion of the stem 12 or,
alternatively, could comprise a plurality of individual portions.
The addition of the web 30 allows the medicator 10 to carry
additional medication and provides a greater surface area of
medication if desired. The mesh or web 30 may be formed from
flexible plastic netting, fabric mesh, polymeric film or other
suitable material, and may be attached to the stem 12 by any
suitable method, such as welding, cementing or stitching.
Now with particular reference to FIGS. 7a-e and 8 a second
embodiment of the present invention will be described. In this
embodiment, the vaginal medicator generally designated 32, includes
a looped stem 34 connected to an anchor 36 which may be identical
to any of the various anchors described previously with respect to
the first embodiment depicted in FIGS. 1 - 6. As in the first
embodiment, a pullout string 38 is also provided. The looped stem
34 is dimensioned so as to reach the posterior fornix of the vagina
and surround the cervix. As in the first embodiment, slow
dissolving medication 40 surrounds the stem 34. In this embodiment
the looped stem 34 seats behind the cervix, and the substantially
triangular shape of the loop resolves lateral forces from the
surrounding musculature of the vagina into longitudinal forces
along the longitudinal axis of the medicator 32 urging it upwards
into the vagina. Because these features serve to anchor the
medicator 32, the distinct anchor 36 may be omitted as shown in
FIG. 7b without impairing the utilization of the medicator 32. In
such a modification the pullout string 38 is connected directly to
the stem 34 as shown at 42. Other modifications may also be made in
the medicator 32. For example, as shown in FIGS. 7c and 7d the
inner end of the stem 32 may be formed into a circular loop by
including an extra portion 44 or by being necked in as at 46,
respectively, to allow medication to completely surround the
cervix. The stem 34 may also be formed as a hollow drug-permeable
member 34', as shown in FIG. 7e, similar to the modification of the
first embodiment illustrated in FIG. 3. The anchor 36' may also be
hollow and drug-permeable, and may form a continuous core with the
stem 34'. Finally, a web or mesh 48 (FIG. 8) may be extended within
the area enclosed by the stem to allow the medicator to carry
additional medication and to provide a greater surface area of
medication. The mesh or web 48 may be preferably formed in a cup or
concave shape so as to permit the inner end of the looped stem 34
to surround the cervix.
A third embodiment of the present invention is illustrated in FIGS.
9a-b. This embodiment differs from the first described embodiment
only in that a looped end 50 designed to surround the cervix is
provided at the inner end of a stem 52. The remainder of the
medicator, including an anchor 54, a pullout string 56 and
medication 58 may be identical to any of the various modifications
thereof described previously. For example, a cup shaped mesh or web
60 (FIG. 9b) may be included within the looped end 50 in a similar
manner to the modifications of the other embodiments described with
respect to FIGS. 6 and 8. In this embodiment, the loop 50
surrounding the cervix may adequately serve to anchor the medicator
in place. Therefore, the distinct anchor 54 may be deleted.
Other modifications and variations will also become apparent to
those skilled in the art. For example, any of the above embodiments
or modifications thereof may be further modified by angling,
bending or curving the stem to allow the medicator to more
naturally conform to the anterior and posterior fornices of the
vagina adjacent the cervix.
Each of the embodiments of the present invention and the various
modifications thereof may easily be used. The vaginal medicator is
inserted up into the vaginal canal with the inner end of the stem
reaching up into the region of the cervix, and the anchor being
seated in and held in place by the constricting muscles at the
entrance to the vaginal canal. With this configuration, medication
whether to be for local or systemic purposes may be administered
along the entire length of the vaginal canal or any portion
thereof.
Once inserted the medication slowly dissolves either by virtue of
body temperature or body fluids. As described in detail previously,
various modifications may be made to increase the amount or surface
of medication to a desired area. For example, additional medication
24 or a drug-permeable bulb 20 may be included at the inner end of
the stem 12 of the first embodiment. Furthermore, where increased
delivery of medication is desired in the cervix area the embodiment
of FIGS. 7a-e, 8 or that of FIGS. 9a-b may be utilized so that the
cervix is surrounded by medication. Further increases in the amount
and surface area of medication may be had by utilizing the mesh or
web modifications discussed previously with respect to FIGS. 6, 8
and 9b.
In the latter two described embodiments, the loops of the stem may
be compressed for ease of insertion, and the medicator is
positioned so that the inner loop of the stem surrounds the cervix.
The elastic memory of the stems and the amorphous characteristic of
the medication will restore the shape of medication and prevent
cracking or shifting of the medication. All of these embodiments
are easily accommodated within the vaginal canal and are as
comfortable to use or wear as an ordinary tampon.
Thus, an improved vaginal medicator has been provided withich
significantly improves the application and supply of both local and
systemic medication to the vaginal canal, is easily used, and is
comfortable to wear.
It is believed that the many advantages of the present invention
will now be apparent to those skilled in the art. It will also be
apparent that a number or variations and modifications may be made
without departing from its spirit and scope. Accordingly, the
foregoing description is to be construed as illustrative only,
rather than limiting.
* * * * *