Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
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j¦ This inventlon is directed toward porous cellular
¦ topical applicators and more particularly toward the production
¦ of such applicators which are smooth-skinned, pre-impregnated
¦l and mounted onto a support member in a single operation at
considerable savings in production cost and capital investment.
A variety of applicators for the dispensing of medica-
¦ments have been known or used for some time. Many of these
¦I swabbing implements ~tilize as both the carrier and applicating
lo llsurface some spongy, hydrophilic material sucn as polyurethane
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foam. One such applicator disclosed in U.S. Patent No. 2,170,222
by Strauss consists of a douching swab made of rubber sponge
which can be connected to a syrin~e hosq. Means for attaching
the sponge to its support member ara not specified.
Another patented arrangement described by Leonard et al.
is U.S. Patent No. 3,228,398 embodies a cylindrical polyurethane
foam sponge applicator secured to an elongated rigid stem by
¦ means of a combination of a surgical tape substrate and coatings
I ¦ of glue. In U.S. Patent No. 3,262,450, Elias discloses a smooth-
¦ surfaced, topical spongy material for vaginal insertion made of
reticulated polyurethane foam with a maximum cell size of 1.5 mm.
¦ Another type of applicator disclosed by Fournier in U.S. Patent
¦ No. 3,818,911 consists of a pre-moistened vaginal swab machined
¦ from cured polymeric foam and shaped in the form of inverted
cup-like convolutious for effective removal of deb~is.
All the foregoing devices utilizing reticulated (i.e.
open cell) polyurethane foam as the applicating surface suffer
from a number of physical shortcomings and severe cost dis,-
I advantages over the present technology. One such physical short-
l coming is caused by the resulting reticulated surface of the
i machined body of polyurethane foam. No matter how small, the
opened cells of such applicators present surface discontinuities
~¦which, upon repeated use, can cause friction and irritation on
~the delicate tissues of the mucous membranes. In contrast, the
!¦ present technology allo-~s the body of the foam applicator to be
covered by a highly porous but continuous skin surface whose
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smoothness is very cLose to the human skin.
Another physical shortcoming resides in the fact that
¦ the cellular body of all the foregoing applicators has to be
¦ machined and treated following a lona series of slow and costly
operations. Typically, applicators of the type described by
Leonard et al. and .Fournier have to be produced in the following
sequence: Cutting a block of reticulated foam approximating the
dimensions of the applicating head; hot-knife machining the block
l to final shape which may take several intermediate steps depen~-
¦ ing upon the comple~ity of the structure; boring the foam head
¦! to insert the support stem; placing the adhesive and assembling
i the parts; smoothing the edges by abrasion, post-impregnating
the swab by dip-saturation and drying, if required. Altogether,
applicators of this type may require as many as ten manufacturing
¦¦ steps involving a substantial amount of equipment and labor In
contrast, the present technology allows the production of a
¦ similar article, smooth-skinned, pre-impregnated and mounted onto
¦ a support member in one single operation at considerable.savings
¦ in production cost and capital investme~t.
SUMMARY AND OBJECTS OF THE INVENTION
Accordingly the present invention provides a poly-
meric foam applicator and a method of producing the same that
will avoid the above drawbacks of present devices.
The applicator used for the treatment of body or
animal cavities, can have a moist or dry hydrophilic and/or
hydrophobic polyurethane foam swab of various densities into
which water-active medicaments, soaps, detergents, emollients
and combinations thereof can be uniformly and integrally
dispersed.
The polyurethane foam applicator can contain up to
60 percent by weight of medicaments such as bactericides,
germicides, antibiotics and the like for use in "prepping"
patients or animals undergoing vaginal, cervical, rectal or
peri-anal surgery.
It is possible to dispense any of the foregoing
types of medications either through a foam swab or by means of
a soluble shell of medications applied onto the surface of the
swab or by means of a separate semi-rigid soluble sheath of
medications slideable thereon or through a combination of all
three methods.
The present invention can also provide a means of
aispensing medications containing an effervescent agent over
a ~ustained period of time.
The present invent;on also provides a method of
manufacture for the various types of applicators and soluble
medicated sleeves disclosed herein.
The manner in which the foregoing and various addi-
tional advantages of the present invention are obtained will
become apparent from the following detailed description.
In accordance w~th the invention there is provided
an applicator for treating a body cavity comprising: a
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centrally located core member; a polymeric foam element
of predetermined shape substantially surrounding and being
secured to said core member; an applicator for treating
a body cavity comprising; a centrally located core member;
a polymeric foam element of predetermined shape substantially ~ '
surrounding and being secured to said core member; said
foam element being preimpregnated with between 10 and 60
percent by weight of the foam an additive selected from
a group consisting of medicaments, bactericides, antibiotices,
germicides, fungicides, spermicides, soaps, detergents
and emollients during manufacture of said foam so that
said additive is dispersed uniformly therein. ~
Also provided is a method of producing an applicator -
for treating a body cavity comprising the steps of: mixing a
polymeric foamable material to obtain a partial polymerized
mass; adding a predetermined additive to said mass, said
additive being selected from the group consisting of medica-
ments, bactericides, antibiotics, germicides, fungicides,
spermicides, soaps, detergents and emollients; mixing said
combined mass and additive to substantially evenly disperse
said additive; pouring the mixture into a mold and forming
the same into a predetermined shape. ~'~
Brief Description of t-he ~rawings
For the purpose of illustrating the invention, there
are shown in the accompanying drawings forms which are
presently preferred; it being understood that the invention
is not intended to be limited to the precise arrangements and
instrumentalities shown.
Figure 1 is a front elevational view partly in
cross seCtion and partly in phantom of a polymeric applicator
constructed in accordance with the principles of the present
invention;
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Figure 2 is a side elevational view of the device
shown in Figure l;
Figure 3 is a cross sectional view taken through ::
the line 3-3 of Figure l;
Figure 4 is an elevational view of a modified form
of the invention;
Figure 5 is a cross sectional view of the device
shown in Figure 4;
Figure 6 is a cross sectional view taken through
7 0 the line 6-6 of Figure 4;
Figure 7 is a front elevational view of another
embodiment of the invention showing the handle in its folded
position
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for packaging;
Figure 8 is a cross sectional view of the device of
Figure 7; .
Figure 9 is a cross sectional view taken through the
line 9-9 of Figure 7;
¦ Figure 10 is an elevational view shown partly in cross
l section of an even further embodiment of the invention;
: il igure 11 is a bottom plan view of the device sho~n in ¦
l Figure 10;
¦ Figures 12, 13 and 14 are elevational views, partly in
¦ cross section, of still further ambodiments oE the invention;
¦ Figure 15 is a front cross sectional view of an additio ~:~
¦ al embodiment of the invention; ~:
Figure 16 is a cross sectional view taken through the
line 16-16 of Figure 15;
¦ Figure 17 is an elevational view of a medicated
, I applicator in the form of a therapeutic tampon constructed in
¦ accordance with the principles of the present invention;
1I Figure 18 is a bottom view of the device shown in
20 ¦¦ Figure 17;
¦¦ Figure 19 is a cross sectional view of the device shown
in Figure 17 and further demonstrating the use of an inserter;
Figure 20 is a cross sectional view of a modified form I
of the device shown in Figurs 17;
i Figu.re 21 is an elevational view of an applicator in
I the form of a disposable douching assembly and shown in its
:
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assembled state;
Figure 22 is a cross sectional view of the device shown
in Figure 21 in its packaged condition before assembly:
Figure 23 is an elevational view of a medicated sheath
which may be used in conjunction with the device of Figure 21;
Figure 24 is an elevational view, partially broken away,
¦ of the device of Figure 21 in combination with a medicated sheath;
Figure 25 is a cross sectional view taken through the
l line 25-25 of Figure 24;
1 Figure 26 is a cross sectional view of a disposable
l douching sleeve;
i Figure 27 is a bottom view of the sleeve shown in
, Figure 26;
Figure 28 is a modified form of the douching sLeeve
shown in Figure 26 and further shown in combination with a
douching support;
l Figure 29 is a cross sectional view of the device shown
¦! in Fiyure 28, and ,
¦ Figure 30 is a cross sectional view of a mold cavity
¦ illustrating the manner in whicn the various applicators of the
, present invention may be manufactured.
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Detailed Description of the Invention
Although functionally and therapeutically related, the
various polymeric medicated applicators of the present invention
¦ can be classified into three structural groups;
1. Topical swab and surgical applicator for digital
handling. (Figures 1-16)
2. Intra-vaginal therapeutic tampon for prolonged
l body insertion. (Figures 17-20)
! 3. Manually-handled douching swab implement with
l medicated sleeve. (Figures 21-29)
As generally shown in Figures 1-16, this type of
!¦ digital applicator is comprised essentially of two components:
¦¦ a unitary handle-stem structure lQ and 11 equipped toward its
¦ mid-section with an optional safety flange 13. Flange 13 provide~
¦¦ support for a pre-impregnated polyurethane foam-applicating
surface 12 of generally cylindrical shape. In addition, the swab
portion 12 of the applicator can incorporate a thin, pliable
shell 34 (Figure 15) of absorbable medications either mel~able
I! to internal body heat and/or miscible on contact with body fluids.
¦ While the swab head is seen to range from two to five inches in
¦ length, its diameter should preferably not exceed one inch for
human use.
The handle-stem element 10 and 11 can either have a 1
I flat or round cross section and it can be made of either plastic,
i~ wood or of some paper composition such as twisted kraft, card-
board or plastic reinforced paper. If made of plastic, the
tructure can either be in]ection-molded or extruded from such
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resins as polyethylene, polypropylene, polyester, polyimide or
polyphenylene oxide.
Depending upon the chosen material colnpositio~, the
handle portion 10 can be made rigid and aligned straight with
the stem 11 as shown in Figure 12 or angled at 10 to 15 degrees
from the normal for self-use convenience (Figures 1 and 2). Or,
still further, the handle can be made both flexible and foldable
alongside the body of the swab as s'nown in Figures 6 and 9.
These and other design variances will be described in fuller
details below along with the description of specific applicators.
Irrespective of the material used, the stem portion 11 ¦
of the structure must incorporate two important physical features~
essential to the proper functioning of the product. First, it ¦
must have foam adhering surface characteristics and it must have
a safety tip-searching head co~nbination.
As will be explained in more detail hereinafter, the
manufacturing principle of the present applicator involves a two-
cavity mold 300 into which the handle-stem element 10 and;ll is
secured in a vertical position and around which the uniform
reactiny mixture is poured. (See Figure 30) Upon curing, the
foam solidifies around the stem 11 and takes the shape of the
cavity wnich opens laterally to release the swab assembly. But
for the foam to adhere properly to the plastic stem, grippable
surface discontinuities of various kinds and preferably perfora-
tions through the stem must be pro-~ided to eliminate the need
for substrate material or for some adhesive requiring additional
manufacturing steps
As sho~n in Figures 1, 2, 13, 14, 15 and 30, holes 14
incorporated thro~gh the foam-supporting structure 11 are
particularly desirable as they p~ovide channels for the foamable
polymer to flow through during the pouring operation and to
¦ solidify into transversal pins or rungs 15 linking both sides of
the swab element 12 through the stem portion 11. Alternatively,
l but preferably in conjunction ~ith perforations, grippable surfac~
i discontinuities could take the form of circular grooves 16,
l annular ridges 17 or notches 18 as shown in Figures 1 and 2, or
! any number of variations thereof such as lugs or threads (not
! sh~wn). For example, the paper-composition stems lla of Figures
10 and 12 incorporate on their surfaces dimples 19 or knurls 20.
¦¦ Still further, the stem-support element of Figures 5 and 8 could
i be in the for-n of an extruded and flexible hollow straw llb
whose bello~s-like surface discontinuities 24 provide an
appropriate grip for the foam sheath to adhere to and to act
! as a handle.
!¦ The second important design aspect of the device lies
¦¦ in a com'~ination safety tip and searching head surmounting the
20 ¦j distal end of the stem 11 for the dual purpose of preventing
I¦ internal injury and to help facilitate passage through sphincter
muscles. As shown in Figures 1, 2, 14 and 15, the integral
end-portion 21 of such flat support stems are rounded or bulbous
s'naped and are positioned relatively close to the outer edge of
the sYlab to prevent the foam froln "~unciling out" at the point
of insertion. Alternately, injection molded tips can be shaped
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n the for-n oE a f1ared cup 22 sh~wn in Figure 13, while other
rod-like support structures such as those of Fiyures 5, 8, lO
and 12 are separately fitted with a round or semi-spherical tip
23 of rubber or soft plastic.
As will become apparent, the particular polymer
technology of the present invention allows the foam head to be
made in virtually any shape and ~ith a highly permeable skin
for liquid absorption or diffusion. The configuration and
surface cnaracteristics of the swab can therafore be "tailored"
to the specific requiremonts of any therapeutic application,
particularly those of an internal nature.
For example, s~abs primarily designed to scoop out
debris or undesirable secretions are s'nown in Figures 4 through
9. The swab element of Figures 4 and 5 is comprised of a
cylindrically shaped body 12 of uniform diameter with a rounded
or oviform top for easy insertion into body or animal cavities.
Mechanical scr~bbing is accomplished by means of a plurality of
semi-circular annular grooves 25 regularly spaced along the
length of the swab and into whicn debris can accumulate for
removal.
In the swab design of Figures 8 and 9, the scooping
action is enhanced further by having a similar series of annular
troughs 25a separated by concave sections 26 terminating in soft,
pliable fins 27, ~s the swab is being manipulated up and down a
cavity, the pliable fins 27 are designed to penetrate into the
folds o the canal and to exert thereon a gentle scraping action
in both directions scooping debris into the troughs 25a. ¦
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In the designs shown in Figures 4 through 9, the safety
flange 13a is made of foam and is integral with the swab element
12. The handle section lOa is also covered by a sheath lOb of
¦ the same foam so that the swab element 12, flange 13a and their
¦ handle form a unitary foam construction around the central
¦ supporting structure. Due to the inherent flexibility of the
straw and foam composition of the handle lOa, it can be con-
¦ veniently folded upwardly at 180 degrees as shown in Figures 8
I and 9. For packaging convenience, the handle element lOa can
be snapped folded and held into a compliant and cooperating open
cavity 28 provided on the side of the flange 13a as sho-~n in
Figures 6, 7, 8 and 9.
Swab configurations shown in Figures 10 and 12 are
designed for situations where a softer scrubbing action is in-
dicated. Referring to Figures 10 and 1], the cylindrical foam
i applicator 12 incorporates a series of annular V-shaped recesses
¦ 25b forming lateral notches 31 whose depth can range from two to
~¦ five millimeters depending upon the desired effect. Simiiarly,
1¦ the frequency of these annular recesses can also vary from two
20 1¦ to four per inch depending upon the desired degree of mechanical
,~ cleansing
li Alternately, the scraping edges can also be gently
ilcontoured to reduce friction. As shown in Figure 12, the swab
ilelement 12 consists of a series of superposed, truncated triangulaF
!' sections 29 ~ith a rounded base ~orming a series of slanted scales
¦ 31a whose depth and Erequency can be maùe to vary as deslred.
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~ In stilL another class of applicators ~here absorption
i or drug release are preferred ~ver scrubbing ability, the foam
swab is made -to assume a smo~ther and/or shallower profile as
¦ shown in Figures 13 through 16. In Figure 13, the swab is made
! up of a series of superposed concave sections 30 creating at
! their points of junction a corresponding series of conical
~ scraping edges 3lb. In this embodiment, the flange arran~ement
¦ differs somewhat from the previous applicators in that it is com-.
¦ prised of two superposed flange thicknesses: a flat flange
1 sup2ort 13c integral with the plastic molded handle 10 and a
foam flange 13a integral with the swab element 12.
In another configuration shown in Figure 14, the swab
is composed of a series of alternating convex and concave section~
¦ 32a and 32b eliminating the formation of scraping edges. This
¦ embodiment shows still another variance of the safety flange.
¦ The plastic handle 10 incorporates a circular trough 13d in the
¦ order of one and a half incnes in diameter housing a foam base
li 13a integral with the swab element 12. The advantages of such
¦¦ flange arrangement are two-fold: a) First, in case of dripping
1¦ during insertion of the swab, excess fluid is collected by the
comhination foam flange 13a and leak-proof plastic receptacle
13d; b) Second, the rigidity of the flange structure guarantees
¦¦ that the swab cannot be pushed into any body cavity beyond a
¦¦ given level whicn is a beneficial feature for consumer applica-
¦¦ tions.
~ In another embodiment sho~n in Figures 15 and 16, the
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body of th generally cylindrical swab 12 is composed o~ a series~
of truncated spheres 33 superposed on top of eacn other and
forming one integral bod~ of foam secured to the stem 11. Con-
tiguous ~ith the base of the swab 12 (but not integral therewith),
the applicator incorporates a circular and concave safety flange
oE a still different structure yet similar in concept to the one
! sho~n in Figure 14. Cornposed of a highly absorbent grade of
¦¦ polyurethane foam to soak up excess fluid from the inserted swab,
¦¦ the foam flange 13e is encased in a pre-formed trough 13f of
¦¦ thermoformable plastic such as vinyl, polyethylene, latex or
Il even coated paper. To accomplish a similar result, the base of
¦~ foam flange 13a in Figures 10 and 12 could be sprayed after
¦ molding with some water-proof compound including such materials
as late:c, neoprene, natural rubber, waxes or the like. In this
¦ particular applicator, the foam composition of the~swab 12 is
¦ different from the foam composition o~ the flange element 13e andl
1¦ each foam element, even though molded separately, can be cast in ¦
il sequence in the same mold.
Il The applicator shown in Figuras 15 and 16 also differs
¦~ from the previously described devices in that it includes a
'll medicated s'nell 34 surrounding the foam swab 12. This applicator
!l is preferably manufactured in the following manner.
Step 1. Tne pre-formed flange 13f and medicated shell
¦ irlserts 3~ (not shol~n) are positioned into the open mold as shown ¦
¦ in Figure 30. While the flange inserts are pre-forlned preferably ¦
from thermoformable materials, the medicated shell 34 can be made
¦in several ways: a) its lngredients can be pre-cast into a
ll~b~l~
sm~oth, pliable cylinder and inserted into the closed c~vity
b) the ingredients can be hot-sprayed onto the open surfaces ¦
301d and 301b oE the cavity; c) 'the ingradients can be brush-
coated thereon; d) or a flat sheet of ingredients can be press-
fitted into each half of the open cavities.
Step 2 The handle-stem element 10 and 11 is inserted
vertically into the closed cavity and locked in at the proper -~
level.
Step 3. Foam #l mix comprised of liquid resins and medica-
¦ tions added prior to foaming is poured into the closed cavity.
Step 4. The foam is allowed to rise and to jell intb swabelement 12. I~ a pre-cast cylindrical shell 34 of medications is
used, the internal pressure exerted by the rising foam will force
the sides of the cylinder against the walls of the cavity, thereby
shaping it into the same configuration as the swab element.
Irrespective of the way the shell ingredients are applied to the
¦ cavity, they will intimately adhere to the surface of the swab.
Step 5. A highly hydrophilic foam mix X2 is then poured
l into flange cavity 13f.
l Step 6. The foam is allowad to rise and to jell into solid ¦
! flange 13e.
¦ Step 7. Cavities may be opened to release the swab assembly
i¦ with its medicated shell.
As will become app,arent hereinaft~r, the foragoing
jl methodology also applies in part or in whole to the therapeutic
tampon of Figures 19 and 20 and to the douching sleeve of Figura
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26. However, the shell coating could be alternately applied to
the foam element by dippiny it into a bath after molding. It
should also be apparent that more than one shell 34 could be
employed and that each shell layer could be comprised of the
same or different medication and having the same or different
solubility characteristics.
l ~hile a generally cylindrical s-~ab is deemed best
"~ suited for any microbicidal applicator to sterilize such areas
! as the cervix, vaginal vault, perineal and ano-rectal areas, it
~ should be understood that the foregoing embodiments need not be
solely confined to cylindrical or tubular shapes. Although not
shown, topical foam swabs could assume any numher of shapes and/
or geometries without departing from the polymer technology of
I the present invention.
The structure of the foregoing embodiments for topical
¦ swabs have been modified into a novel concept for an intra-vaginal
therapeutic tampon for the treatment of moniliasis, trichomonasis,
cervicitis and other non-specific vaginal disorders. Normally,
I these disorders require frequent internal applications of soluble
1 cream-based or yelatin-based medications in suppository form
!! ~Jhich, upon melting, drip, cause soiling and discomfort.
By capitalizing on the drug-carrying and drug-release
properties of the present foam technology to be described in more
¦ detail below, a much improve~ mode of treatment has been developed
¦ with the followillg advantages:
1. Grea~er surfacs contact between medications and diseased
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~ s~
mucous surEaces.
1 2. Sustained dru~ release ovar a controlled period of time.
! 3. Decreased number of applications per day.
4. Greater co:nfort and mobility for the user.
! 5. No bypass, leak-proof.
Referring to ~igures 17 through 20, the therapeutic
tampon is com~rised of a series of superposed truncated spheres
102 forming one integral body of foam 101 of generally cylindrica
l shape. While some degree of surface discontinuity is desirable
jj from the standpoint of anatomical conformity, the tampon element
101 could assume a perfectly smooth cylindrical shape without
affectiny the drug release properties of the foam.
i T.he base of the applicator 101 is comprised of two or
; more rinys 103 of foam substantially larger in diameter than the
¦ body of the ta~pon. Rings 103 ara designed to exert pressure
!j against the vestibule of the vaginal canal and to act like the
11 1
!I gaskets of a plug to prevent by-pass of the melted medicaments.
! In addition, the external surface of these rings is sheathed with
! a pre-formed layer 104 of flexible, water-proof material such as
I vinyl, latex, wax or polyethylene. Alternately, the base of the
tampon could be dip-coated or spray-coated with similar leak-
proof compounds.
j Insertion and retrieval of the tampon can be accomplishecl
¦ in two different ways depend~ng upon the internal construction of
the device. As shown in Figures 18 and 19, one embodiment is
comprised of a central tubular core 105 of semi-rigid material
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¦ made from polyurethane, nylon, latex or paper-coated laminates.
¦! The tubular core 105 e~Ytends almost -through the entire length of
! the tampon and incorporates an a~ial, internal bore 106 of
¦ substantially the same length. The diameter of the bore 106 is
in the order of five to seven millimeters and allows the rod-like
plunger 107 of a reusable inserter 110 to be introduced therein tc
¦ position the tampon into the vaginal cavity. Once the tampon is
¦ in place, the plunger 107 is slid out and removed.
i ~o safeguards are provided against perforations
10 1¦ First, a flange 109, integral with the inserter 110, is designed
to push up the tampon from the base of its semi-rigid core 105
while the plunger 107 exerts a simultaneous push from the upper ¦
l portion of the tampon. Since both elements are displacing the
- ! tampon at the same rate, perforation from the plunger is made
impossible by the position of the flange against the base of the
! axial core 105. In addition, the uppermost portion of the tubular
¦ core 105 incorporates an extension of solid material 103 as
reinforcement against the tip o~ the plunger.
1~ This type of therapeutic tampon comes e~uipped with a
1! set of recall strings 111 tied around the base of the tampon just¦
l~l above the neck of the enlarged leak-proof rings 103 as shown in
il Pigure 17. These recall strings 111 are used to withdraw the
¦I device similar to any commercial type of catamenial tampon.
¦ Alternately, the recall stri~gs 111 can be incorporated in the
! mold for the polymeric material of the core 105 and allo~ed to
j extend from the base of the taMpon.
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Another embodilnent shown in Figure 20 incorporates a
solid, axial and rod-like core 112 of semi-rigid, non-breakable.
material extending substantially through the entire length of
the body of foam 101. While the generally cylindrical foam
portion of the tampon can assume any number of surface feature~, .
the core element 112 should preferably be made of polyurethane,
elastosner, nylon, latex, polypropylene, or combinations thereof.
In addition to a plurality of leak-proof, gasket-like
rings 103 described earlier, the bottom section of the tampon
¦ incorporates a semi-spherical cavity 113 through wnich protrudes
the tail-end of the core element 112 shaped in the form of an
integral loop 114. While the user can grasp through the open ¦
¦¦ cavity 113 the lowermost section of the polymeric core 112 and
¦¦ utilize it as means of inserting the tampon, the recall loop 114
¦l serves the purpose of withdrawing the device.
¦ The basic concept of the topical foam swab as a carrier
¦ and applicator of water-active d.rugs has been e~;panded further
l to a doucning swab implement with or without a soluble sheath of l
il medications as generally shown in Figures 21 through 25. Alter- !
20 ¦¦ nately, the drug carrier could be a disposable sleeve of medi-
I cated polyurethane foarn slideable over a douching tip shown in
Figures 26 through 29.
Referring more specifically to Figures 21 and 22, the
douching swab assembly comprises a body of highly porous foam 201
¦ centered over a plastic douchiny tip 202 incorporating a plurality
o~ exit holes 205 ~or the doucning li~uid. To help secure the
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oam to its plastic support, a se~ies of annular knurls 203 and
saw-tooth fittings 204 are incorporated into the tip. The
douching tip 202 is connected through a flared neck 206 to a
¦ reversible screw cap 207. For packaging convenience and space
l economy, such cap allo~s the douching swab element 201 to be
! screwed upside do-~n into the empty douching container 208 and is
sealed on its op~osite open side by means of a peel-off strip of I
foil 209. The douching container could be either a squeeze-type ¦
I blow-molded bottle or a collapsible bladder of plastic film or ¦ I
laminate.
To assemble the douching implement, the foil 209 is
removed and the douching swab is inverted and screwed onto the
top of its container 203 which has been previously filled with
ater. (See Figure 21) Upon squeezing the container, the water
oozes out throug'n the swab along with the medicaments. These
¦ medicaments can be admixed to the water in powdered or liquid
¦ concentrate form, Alternately, the~ can be pre-impragnated into
¦the douching swab foam 201 or incorporated as a soluble,shell to
¦the surface of the s~ab. Even further, they can ba deliverad by
29 l means of a semi-rigid sheath 210 slideable over the douching
js~ab 201 and soluble to body heat and/or douching liquid as shown
il in Figures 23, 24 and 25. To speed the liquefaction of the medi-
¦cated sheath 210, small perforations 211 can be provided over its
¦¦surface so that both internal and e~ternal sides of the sheath
¦can be subjected to water contact from the douching nozzle.
As sho~,~n in Figures 26 through 29, a more economical
¦~alternative to the foregoing douchillg embodiment is comprised of
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a disposable sleeve of porous foaM 212 incorporating a thin outer
! shell 213 of solul~le medications and slideable over a reusable
I! plastic douching tip 214. As described for the previous swab
¦~ embodiments, the bod~ o~ the foam sleeve 212 can incorporate any
¦I number of surface features, such as superposed concave sections
¦1 215. While the liquid forced through the holes 205 of the
douching tip 214 will ooze out through the sleeve aLong with the
medicaments, these medicaments can also be diffused either from
l the pre-impregnated foam sleeve 212 or from the soluble shell 213
lo ¦! which can be incorporated to any desired e.~tent over the surface
¦¦ of the applicator. More specifically, the shell can cover the
¦¦ entire appliFator as shown in Figure 19, or only a part thereof
'l¦ such as shown in Figure 26.
I! It can be seen from these descriptions that the fore-
i going douching swab embodiments are therefore capable of achieving
¦¦ a triple therapeutic action, hydraulic, mechanical and medicinal,
I¦ which is deemed to be most beneficial for a substantial num~er of
¦ vaginal disorders. ;
!l As should r-ow be readily apparent from the foregoing
20 1l description, the unique characteristics of the polyurethane
j tecnnology oE the present invention are applicable to a variety
of medicated applicators for body cavities. These applicators
differ mar~edly fro:n the prior art from the combined standpoints
of internal structure, polymeric composition, release of pre-
! impreynated medications and manufacturing method. In a moreprecise way, the core oE the techno-o~y and of its present produc~
~l~b;~lZ
applicati s resides in the abllity of producing a generally
cylindrical body of foam or tubular swab element capable of
incorporating at least nine distinct features:
1) The polymeric swab element can be integrally and
permanently bonded to a variety of internal supporting structures
during the molding operation which obviates the need for sub-
strates, primers, adhesives or any other external devices.
2) The polyurethane swab is inherently covered with an
! e~tremely smooth, thin and pliable skin which is highly porous
1l to the absorption of body fluids and/or to the diffusion of liquid;
medications.
3). The polyurethane foam is highly nydrophilic and is
capable of absorbing up to 25 times its own weight of liquids.
i 4) The polymeric swab can be cast in a mold into virtually
any shape over any kind of supæort which eliminates a large
¦¦ number of costly and time consuming manufacturing steps.
¦ 5) The foam s-~ab can be pre-impregnated by as much as 60
¦ percent by weigi~t with almost any desired combinations of chemicaljs
¦ and/or medications activatable by internal body heat, water con-
20 ¦¦ tact or body fluids.
¦¦ 6) The swab element can be intimately coated with a solid l I
jor semi-solid shell of absorbable medications either melta-ble to 1 i
¦internal bod~ heat andior miscible on contact with body fluids.
¦¦The shell can be comprised of several thin layers of identical
, medications releasable over a period of time w'nile the swab carrier
can be pr -1mpre~nated with a dlffe~ent medic-tion for secondary
1~
treatment of diseased mucous or skin surfaces.
7) The various chemicals and medications admixed to the
foam can be encapsulated for controlled release action.
8) The medications diffused from the foam can be made to
effervesce for better penetration into the crypts and folds of
certain body cavities.
9) Any or all of the above cnaracteristics can be imparted ¦
!I to the swab element in one single molding operation at con-
¦l siderable savings over existing conventional manufacturing
lo 1i methods.
i ~epending therefore upon the chosen type of internal
structure, rnode of handling and medical additives, the foam swab ¦
I can be adapted to an equal variety of products for specific
¦¦ medicinal treatments. For example, fitted with a stem-handle
i¦ support such as shown in Figures 1-16 and pre-imprégnated with
a germicide, the foam swab can be used as a "swabstick" for
¦ medical, surgical or veterinary applications. Fitted with a
flexible core and an appropriate inserter, such as shown in
l Figures 17-20, it can be made into a vaginal or rectal tampon
20 1¦ for the treatment of various disorders. And attached over a
i¦ douching tip, the foam element can be turned into a douching
¦¦ s~ab for routine or therapeutic feminine hygiene as illustrated
¦ in ~igures 21-29.
The foregoing internal and external physical character-¦
i~tics of the foam swab result fro:n the structural arrangement
¦ of the cellular matrix which is composed of collapsed, ruptured,
I ~ 2
stretched, distorted, reticulated and swollen cells as well as
normal cells. Randomly interspersed throughout the cellular
structure are fibrous threads or ~ilaments caused by a particular
over-stirring of the foamable polymers ~hicn increase the struc-
tural strength and resiliency of the foam. Although three to six
times as dense as commercial polyurethane foam produced by existi~
methods, the cellular material of the present invention which has
a densely structured cellular matrix of 6 to 30 lbs./ft.3 is
I easily wetted and readily discharges the pre-impregnated additive
I upon gentle pressure or even upon weak internal muscular actlon. I
Il The preparatory procedure found most suitable utilizes ¦
¦l a first mixing opcration to obtain a partially polymerized mass
¦ and one or more additional mixing operations to regulate the
consistency and viscosity of the polymeric mass during which
¦ medicaments or other additives are dispersed therein. It is
essential, however, that the first mixing s-tep be performed in
¦ the absance of additives which interfere witl1 the foam-making
reactions.
' In the first mixing step, prepolymer urethane resin I ;
1l is admixed and reacted with a catalyst at 500 to 2500 RPM for
30 to 100 seconds to produce the partially reacted polymeric
¦ mass. The prepolymer resin may be prepared from polypropylene
glycol and toluene diisocyanate according to known technology
or they may be purchased commercially. Regardless of the
source, the prepolymer resin to be used in the production of
the oam swabs should have the following characteristics:
~1
S
.
a Brookfield viscosity at 25-C between 5000 and 15,000 CPS,
preferably between 7200 and 9400 CPS; an isocyanate content (NCO)
l between 6 and 12 percent; a hydroxyl number ranging from 40 to
j 80 but preferably between 50 to 60 and a molecular weight of the
polyol component ranging between 1800 and 4000. Among others,
two types of commercially available prepolymer r~sins may ~e used
!1 in the above procedure. These are A) STEPAN F-202 and ~ITCo
¦ L-128, B) GRACE 2001 and 3001.
l The first type such as polyether prepolymer F-202
¦ manufactured by Stepan Chemical Company requires the addition of
1.5 to 5.0 percent by weight of a catalyst consisting by weignt
! analysis of 18 to 22 percent triethanolamine, 10 to 15 percent
triethylenediamine and 60 to 70 percent water.
The second type is preformulated by the manufacturer
in a manner that requires the addition of water oniy to start
the reaction and to o~tain a oamable mass. Examples of such
prepolymer resins are HYPOL 200~ and 3001 manufactured by W. R.
! Grace Chemicals which require, according to the manufacturer's
Il recommendations, the addition of between 30 to 120 parts of water
il per 100 parts o prepolymer resin. In either case, the catalyst
¦¦ ~ystem may also include between 0.5 and 2.0 grams of a cell
modifier such as polydimethylsilo~ane or the equivalent per 100
¦¦ grams of prepolymer resin.
¦ The polymeric mass can also be prepared directly from
!l prepolymer precursors and catalysts by employing the procedure
j~ generally known in the art as the "one step" method and in-
¦ corporating therein the proprietary techniques used during the
~¦ * T.M. -25-
.,, 11
final stages of the mixing procedure.
¦I Because mixing is performed at a low speed for a lon~er
¦i period of time than i5 typical of the prior art, the reaction is
¦¦ retarded and active foaming has not as yet started at the end of
I! this first mixing period. Ho~ever, chemical changes have occurrec I
¦¦ which alter the ~iscoelastic characteristics of the starting
~¦ materials. Consequently a partially reacted polymeric .nass is
i formed ~hose viscosity and density ara sufficiently high to
l allow incorporation of the medicaments without deleterious effect
1 on subsequent polymerization. Properly prepared, the polymeric
mass has a creamy consistency and shows little evidence of
oaming,
The range of medicaments which may be dispersed within
the polyurethane body of foam in the foregoing manner is quite
¦l e~tensive and depends upon the particular use intended. The
¦¦ additives may be particulate solids, ointments or miscible and
immiscible liquids. Active ingredients such as bactericldes,
gerinicides, and antibiotics can be used for the treatment of
'! abnormal vaginal conditions such as moniliasis, trichomonasis and
11 other non-specific types of vaginitis. Other formulations are
also possible for use by physicians to "prep" patients prior to l I
vaginal, cervical or peri-anal surgery. Soaps, detergents, , ¦
I emollients, fragrances and even colors can be used to prepare
il applicators for use in gener~l feminine hygiene. In many
t instances these additives would also be included in foam applica-
~¦Itors for specific purposes as inert carriers of the active
~ -26-
1,
'i
!¦
. . .
llsts5lz
compound. Table I lists and identifies commercially available
medicaments and additives which may be incorporated into the
foam in recommended dosages.
Dry additives and additives in ointment form which
are to be dispersed within the polymeric mass ara preferably
premixed to o~tain a ~niform composition. Because liquid medica-
ments are easily dispersed within the polymeric mass, they may
be either premixed with the dry additives or introduced directly ¦
into the polymeric mass at any time during the second or sub- ¦
j sequent mixing steps, but at least 15 seconds prior to the
l termination of mixing to ensura complete and uniform dis ersion.
! The second mixing step, which is performed at 250 to
lO00 RPM for 15 to lO0 seconds, preferably at 400 to 700 RPM for ¦
30 to 80 seconds, not only serves to disperse the additives
within the polymaric mass to obtain a uniform reacting mixture,
but also regulates cell formation. The agitation disperses
evolved gases which are necessary for foaming of the polymeric
l reactants. Hence, activa foaming is minimized. The agitation
I produces shear forces that tear or shred a portion of the cells
formed during this step. Thus, the finished applicator head,
! when observed under a microscope, contains fibrous threads of ¦
polymerized polyurethane interwoven throughout the cellular matri~.
i Longer mixing promotes polymerization in the absence of j
foaming and yields denser, more fibrous structures. If mixing
were not prolonged as taught by the preseilt invention, the uniform
¦¦reacting mixture would not attain the density necessary to support
1~ -27-
Il
Il
lZ
111
the weight of the medicaments. The mixture would begin to foam
and then collapse. If the first mixing step were extended until
the viscosity and density were s~fficient to allow incorporation
of the medicaments, the polymeric mass would then be too viscous'
to work properly, and the medicaments would not be distributed
uniformly.
The shear forces of the second mixing step also create
large numbers of distorted, collapsed and stretched cells. Many
of these cells, even those forming the skin of the final
applicator head, are hydrophilic in nature, and allow water to
enter and to dissolve the medicaments contained therein.' Thus,
the foam applicators do not require a highly reticulated surface
for the release of thè additives. At the end of the second
mixing step, the twica mixed polymeric mass, i.e. the uniform
reacting mixture, is ready to be molded to the proper swab
configuration.
The foam applicator is made by pouring the uniform
reacting mixture obtained by the foregoing procedure into a
closed two-cavity mold containing the desired supporting structur~ .
~Figure 30) The mold is desirably constructed of two mating
sections operating 'laterally against each other to allow the
reacting mixture to be poured in and to release the finished '-
applicator assembly. The polymeric mix is sufficiently fluid
to conform exactly to the sh,ape of the cavities as it begins to
foam. Of particular importance, the foaming material can also j
penetrate holes and surround intricate surface discontinuities l
i
I -28- 1 ~
! ~ 2
thereby forming an integral boAd between foam and support. While
the foaming material is densified by expanding in a close mold,
the finished body of foam is soft, pliable and can readily absorb
and release water or body fluids.
Although the release of the added ingredients is slower
! and more linear than in conventional bodies of foam, substantiall
longer use can still be obtained by encapsulating, in part or in
whole, medicaments and other additives. Encapsulation can be
achieved by two methods. In the first method, a previously
prepared body of foam containing additives is shredded or
cotnminuted to between 20 to 100 U.S. Standard Sieve and then
blended into the partially reacted mass during the second mixing
¦ stage. Although all of the additives may be encapsulated by this
method, it is most useful where only a liquid additive, typically
i an emollient, is to be coated, or where a mixture of emollient
¦ and dry additives could not be encapsulated effectively in any
~ other way.
¦ The second method encapsulates the additives, either
~ individually or in combination with one another with a water
j soluble film using a film forming material such as polyvinyl
alcohol, polyvinyl pyrrolidone, hydroxymethyl cellulose, polyvinyl
methylether, polyacrylamide or Triton X-100. An atomized mist
¦1 of a 1 to 5 percent aqueous solution of the film forlner is
sprayed onto the additive(s), and the moisture is allowed to
evaporate therefrom. This operation may be carried out in a
iltumble dryer or fluidized bed dryer with warm air used for drying.
I * T.M. -29-
~ ~ .
,., ~ . ,
The treated ~dditives a~e then co~nminuted to between 60 and 100
¦I mesh and added to the partially reacted Inass in the sacond mixing
step. The second method is preferred for dry additive mixtures
that do not tend to clump or agglomerate. These and other
cl-aracteristics of the polymeric foam will be made even more
apparent with the e~amples of the various formulations and
preparatory steps described below.
~¦ While a specific preferred molding tec'nnique for the
il applicator is described above, substantially any known process
o !I may be used for forming the shells and sheaths utilizing, for
') example, the formulations set forth in Table I. Among other
¦ techniques, the shell may be precast into a cylindrical shape,
the shell ingredients nay be sprayed or brushed onto the mold
walls or flat sheets of material may be press-fitted onto the
Ij mold walls. It would also ~e possible to dip-coat the applicator¦ ;
~¦ after it is molded. The sheath is preferably cast into its
desired shape.
To achieve various rates of dissolution (with ra~pect
ll to time), the glycol bases of the shell or sheath can be varied
20 ¦¦ in composition, A lower melting point is accomplished by
Il decreasing the amount of higher molecular weight glycols whereas,¦
ji to achieve higher melting points, the amount of higher molecular ¦ I
!i weiyht glycols is increased. The proportions for incorporating ¦ 1
water and medications to the glycol base ar~ as follows:
Polyethylene glycol 6000 50~/O
Polyethylene glycol 1500 3~O
2 Purified and Medications 2~o
Il - ,
Theobroma oil (cocoa butter) can be used as a carrier
I of medications for the shell and sheath. This can be prepared
¦ by melting the Theobroma oil and by intimately incorporatin~
into it an equal amount of medicaments by weight. The rest of
the required amount of Theobroma oil is then admixed to the melte
liquid. The ingredients are then cooled down to almost the
desired melting point, unifor~nly mixed and poured into chilled
cavities to cast either a shell or sheath. The melting range of
Theobrolna oil of 30 to 35 C can be increased by the addition of
¦ white wax. Other carriers nay be polyethylene derivative of
sorbitan monostearate (Tween 61*b~ Atlas Chemical), polyoxyethyle
30 stearate (Myrj Sl*by Atlas chemical) or polyoxyl 40 stearate
I (Myrj 5~ by Atlas chemical).
Furthermore, either the shell or the sheath structure
can be composed oE several heat-meltable layers of the same
medications in addition to the pre-medicated body oE foam. Such
arrangement guarantees a prolonged medicinal action particular~y
I u~eful for therapeutic tampons. In effect, depending upon the
¦¦ cnosen composition, a fresh layer of medications can be dissolved
20 ¦¦ for absorption approximately every hour or so.
¦ The present technology also allows for the production
of therapeutic tampons incorporating two different medications
to be applied in sequence which is sometimes required for certain
specific vaginal disorders. ,For example, such a tampon could
comprise a partial outer layer of quickly dissolving cocoa butter
¦¦to facilitate passage and insertion in the vaginal tract. This
¦¦ * T.M.
! -31-
.
' l!
.. . . . . . .
~ &S:~
, ,,. . `'.,".' .~.
outer layer could be followed by two or more full-length inner
layers of medications. Once the shell layers are fully dissolved
a different medication pre-impregnated in the foam could come
into effect activated by either body heat and/or body secretions.
Examples of various formulations for the manufacture
I of applicators in accordance with the present invention are
¦¦ set forth in Table I attached hereto. Eac'n of the seven columns
I under the heading "Foam Swab" in the table corresponds to a
I specific formulation for a swab. Similarly, each of the six
1 columns under the heading "Shell and Sheath" corresponds to a
¦ specific formulation therefor. In order to further illustrate
the various applications of the present invention, set forth
below are severaL specific examples which are taken from Table I.
EXAMPLE I. (Column 2 ingredients)
A topical swab such as iLlustrated in Figures 1-14 for
¦ the treatment of trichomonas is made from the following composi-
'! tions:
,¦ Formula A
~j Diiodohydroxyquin 0.1 gm
20 1 Sodium hauryl Sulfate 0.5 gm
Phenyl Mercuric Acetate 0.003 gm
Papain 0.020 gm
11 .
Formula B
I Hypol 3001* 3.0 gm
¦ H2O Purified 3.0 ml
I Tegostab*B.F 2270 (Goldschmidt) 0.1 gm
'I The ingredients of Formula A are first thoroughly
mixed. With respect to Formula B, the 2270 silicone is first
* T.M.
I -32-
P~
I
.,.il --
5~2
added to the resin. Thereafter, the water is added and these
¦ lngredients are mixed rapidly until foaming is initiated. At
this point the ingredients from F'ormula A are added and the
entire solution is mixed rapidly and poured into the mold.
EXAMPLE II. (Column 7 ingredients)
A surgical swab-stick (germicidal) such as shown in
! Figures 5-16 or an iodine douching swab or sleeve such as shown
I in Figures 21-29 for patient prepping or for therapeutic
I doucning for vaginitis is prepared from the following formulation:
1 Hypol 2001 6.0 gm
i H2O Purified 6.0 mL
Povidone-Iodine (powder) 0.006 gm
~¦ Tegostab 2270 0.6 gm
¦¦ The tegostab is first added to the resin followed by
¦ the ~ater. These ingredients are mixed until foam begins to
! rise or begins to expand. At this point, the povi~one-iodine
powder is added and the mixture is stir-mixed for three to five
seconds before being poured into a mold. For topical use, the
¦¦ povidone-iodine powder may be adjusted to .075 to l perce~t of
,¦ available iodine.
! EXAMPLE III. (Column 6 ingredients)
A vaginal cleanser such as shown in Figures 5-14 or
a douching sleeve (without a shell) such as shown in Figures 26-
29 is formulated as follows:
, ~o~mula A Swab Douching Sleeve
Hypol 2001 6.0 gm 6.0 gm
j? H20 Purified 6.0 ml 6.0 ml
Tegostab 2270 0.6 gm 0.6 gm
Il * T.M.
-33-
!~ ---- -`------ :-- ---' - -
~ ' .
i 11~
Formula B Swab Douching Sleeve
I¦ NACL 0.06 gm 2.25 ym
i Dlsodium Ædedate 0.0003 gm 0.0012 gm
Sodium Lauryl sulfate . 0.15 gm 0.60 gm
¦¦ The tegostab is first added to the water and this
¦¦ mixture is added to the resin and stirred until foam begins to
¦¦ expand. The ingredients of Formula B are then blended thoroughly
¦l and added to Formula A. The entire solution is then stirred
l rapidly and poured into a mold.
! EXAMPLE IV. (Column 1 ingredients)
~! A foam sleeve Eor effervescent doucl~ing such as shown
in Figure 28 for routine feminine hygiene is formulated as
I!follows '
Prepolymer F 202 50 gm
Catalyst 1.25 gm
Sodiu~ l.auryl Sulfate 0.50 gm
Citric Acid 20.0 gm
Sodium Bicarbonate 10.0 gm
ll Polyethylene Glycol 10007.5 gm
20 l~ Polyethylene Glycol 40002.5 gm
The glycols are first blended on a water bath until
liquid and clear. The citrate and bicarbonate are then added
and stirred into the glycols until solidified. This solidified
! mass is chilled and granulated to about 40 to 100 mesh. The
prepolymer F 202, catalyst and sodium lauryl sulfate are rapidly
,I mixed. Whell foaming begins, the granulated mix is added, stirred
; for about three to ten seconds, and poured into molds. The
I! preferred catalyst for this ~ormulation is comprised of H2O 66.6
Il percent; triethanolamine 20.8 percent; triethylenediamine 12.6
30 1I percent,
!
l
! ~ 5iZ
EXAMPL~ V. (Column 8 ingredLents)
A medicated shell for an antifungal tampon illustrated
i in Figure 19 for the treatment of vaginitis is prepared using
¦ the following formulation:
Formula A
Hypol 2001 3.0 gm
Water Purified 3.0 ml
.
Pormula B
l Polyethylene Glycol 4000 1.1 gm
I Polyethylene 51ycol 400 0.6 gm
I Stearyl Alcohol 0.1 gm
! Clotrimazole 0.02 gm ~
The ingredients of Formula s are first thoroughly
¦¦ mixed. The water and prepolymer are then combined and stirred
i until the foam starts to rise. The ingredients of Formula s are
then added, stirrad rapidly for about five seconds and poured
¦l into a mold.
EXAMPLE VI.
I A medicated therapeutic tampon including a shel~ such
20 1 as shown in Figure 19 for the treatment of trichomonas vaginalis,l
!~ monilia (candida albicans) and haemophilus vaginalis is produced !
utilizing three separate formulations: One for the shell and
two for the tampon per se.
! A. Shell Formula (Column 13 ingredients, single unit)
, Polyethylene Glycol 4000 0.7 gm
Polyethylene Glycol 400 1.2 gm
I Stearyl ~lcohol 0.1 gm
,~ Furazolidone 0.275 gm
! Nifuroxime 0.4125 gm
The pDlyethy1ene glyco~ and the stearyl alcohol ara
,
.
heated to about 65 C and stirred. The furazolidone and
¦I nifuroxime are subsequently added, thoroughly mixed and poured
into a shell .nold and c'nilled.
B. Tampon Formula (Column 5 ingredients, 100 units)
Polyethylene Glycol 4000 120 gm
S-tearyl Alcollol 80 gm
Furazolidone 30 gm
Nifuroxime 45 gm
l The polyethylene glycol and stearyl alcohol are heated
~ in a water bath to about 65 C and mixed. After blending, the
l remaining ingredients are added and thoroughly mixed. The
!¦ resulting mixture is then cooled and chilled until solid. This
¦ solid mass is granulated to a range of 40 to 100 nesh.
¦ C. Tampon Formula (Column 5 ingredients, single unit)
Granulated ~ix (as per B above) 2.7 gm
Hypol 2001 3.0 gm
H2O Purified 3.0 'ml
j Tegostab B.F. 2270 (Goldscnmidt) 0.1 gm
Il The tegostab is first added to the resin and then
20 1l combined with the water. These are rapidly mixed until foaming
has started at which time 2,7 gms of the granulated mix from
Formula B above is added. This is stirred rapidly and poured
¦ into a mold.
I! The present invention may be embodied in other specific
il forms without departing from the spirit or essential attributes
! thereof and, accordingly, reference should be made to the
appended claims rather than to the foregoing specification as
j n~icating the scoye of the invention.
-36-
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