U.S. patent number 3,777,755 [Application Number 05/238,305] was granted by the patent office on 1973-12-11 for suppository.
Invention is credited to Harvey H. Groves.
United States Patent |
3,777,755 |
Groves |
December 11, 1973 |
SUPPOSITORY
Abstract
Disclosed is a suppository which includes two smooth-surfaced,
body indissolvable bulbs approximately spherical or ellipsoidal in
shape secured together by a body-indissolvable connecting member.
The cross sectional area of the connecting member combined with any
medication which may surround it is less than the combined cross
sectional area of the bulbs and any medication which may surround
them, so that when the suppository is inserted into the anal canal,
the bulbs at each end straddle the anal sphincter muscles.
Inventors: |
Groves; Harvey H. (Westport,
CT) |
Family
ID: |
22897327 |
Appl.
No.: |
05/238,305 |
Filed: |
March 27, 1972 |
Current U.S.
Class: |
604/286 |
Current CPC
Class: |
A61J
3/08 (20130101); A61M 31/007 (20130101) |
Current International
Class: |
A61J
3/00 (20060101); A61J 3/08 (20060101); A61m
031/00 () |
Field of
Search: |
;128/26X,270,271,285X,296 ;46/47,52 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Medbery; Aldrich F.
Claims
I claim:
1. A device for applying medication to parts of the body comprising
first and second body-indissolvable bulbs centrally secured in
spaced relation by a thin bendable body-indissolvable connecting
member having a smaller cross-sectional area than the
cross-sectional area of said bulbs, said thin bendable
body-indissolvable connecting member comprising means for
supporting a body-dissolvable medication thereabout.
2. The device of claim 1 wherein said thin bendable connecting
member is a hollow plastic tube and wherein said device further
includes a rigid insertion member for extending through at least
one of said bulbs and into said hollow tube for maintaining said
device rigid while being inserted into a body opening.
3. The device of claim 1 wherein said bulbs are plastic bulbs
having a diameter within the range of approximately 3/4 to 3/8 inch
and wherein said thin bendable connecting member has a length in
the range from 11/2 to 3 inches.
4. The device of claim 1 wherein said bulbs and said connecting
member are formed as one continuous piece of smooth plastic or
similar material.
5. The device of claim 1 wherein said bulbs are formed of a spun,
fiberous, absorbing material.
6. The device of claim 5 wherein said material is cotton coated
with a lubricous material (e.g. wax, plastic, or rubber).
7. The device of claim 1 further including another section of the
thin bendable connecting member extending outwardly from one of
said bulbs and away from the other of said bulbs for connecting one
or more smaller bulbs to said one of said bulbs for securing a nose
portion of body-dissolvable medication thereto.
8. The device of claim 1 wherein one of said bulbs includes an
absorbing wad connected on the opposite side from said connecting
member.
9. The device of claim 1 wherein one of said bulbs is at least
partially formed of a loose absorbing material
10. The device of claim 9 wherein one of said bulbs is formed of
tightly spun and packed cotton or other fibrous material and the
other of said bulbs is formed of loosely spun cotton or other
fibrous material.
11. The device of claim 1 further including medication adhered to
one of said bulbs on a surface opposite the side of said connecting
member.
12. The device of claim 1 and further comprising body-dissolvable
medication supported about said connecting member and surrounding
at least one of said bulbs, the cross-sectional area of the
connecting member and medication supported thereabout being smaller
than the cross-sectional area of either of the bulbs and any
medication surrounding said bulbs.
13. A suppository comprising, first and second body-indissolvable
bulbs, each secured to a body-indissolvable thread in proximity to
a different end thereof, and a body-dissolvable medication adhered
to said thread between said bulbs, said thread together with said
medication having a smaller cross-sectional area than said bulbs,
wherein said medication is substantially rigid when outside the
body for providing rigidity of the suppository during
insertion.
14. The device of claim 13 further including at least one smaller
bulb or enlargement between said first and second bulbs to further
secure said medication to said thread.
15. The device of claim 13 wherein said thread has an elasticity
enabling it to stretch under force tending to separate the
bulbs.
16. The device of claim 15 wherein said elasticity enables said
bulbs to increase in separation a distance exceeding approximately
11/2 inches when a force of approximately 2 pounds is applied.
17. The device of claim 13 wherein said bulbs and said medication
include openings for receiving a removable, rigid insertion member
which adds rigidity to the suppository.
18. The device of claim 13 further including at least one smaller
bulb or enlargement between said first and second bulbs to further
secure said medication to said thin bendable connecting member.
19. A suppository comprising first and second body-indissolvable
bulbs secured in spaced relation by a body-indissolvable thread
supporting a body-dissolvable medication around said thread and
between said bulbs, wherein said medication is substantially rigid
when outside the body for providing rigidity of the suppository
during insertion.
20. The device of claim 19 wherein said bulbs are formed of a spun,
fibrous, absorbing material.
Description
BACKGROUND OF THE INVENTION
The present invention relates to the field of devices for applying
medicine to the body and particularly to the field of
suppositories.
One of the principal requirements for applying topical medication
is that the medication remain in the desired body area for
sufficient duration of time. For example, in the treatment of
hemorrhoids in the anal canal, it is desirable that the medication
be applied over many hours. Due to the normal functioning of the
sphincter muscle, however, an inserted suppository tends to be
either propelled upwardly into the rectum away from the anal canal
or be propelled downwardly and discharged from the body. In either
of these cases, the medication is not properly maintained at the
desired location for a sufficient duration of time.
Prior attempts at overcoming the problem of maintaining medication
in the anal canal have not been sufficiently satisfactory. Those
suppositories having head or tail portions comprised of a
body-dissolvable solid, for example, those having an oil or wax
base, are ineffective after the head or tail portion dissolves
because the suppository slips or is forced away from its desired
position straddling the anal sphincter muscle. Those suppositories
utilizing body-dissolvable materials to form flange or disc
portions are irritating to the tissues of the anal verge,
especially after being in place several hours and being subjected
to normal body movements, and more so if some or all of the
medication has been dissolved away. Other suppositories are complex
and therefore cannot be manufactured at a sufficiently low cost to
satisfy the needs of the consumer market. Other suppositories in
the prior art have employed rigid and relatively cylindrical
members which enclose a reservoir of medication which seeps through
perforations in the cylinder wall to apply the medication to the
disturbed area. These reservoir devices are not entirely
satisfactory to the extent that the medicine is impeded from
seeping through the wall and from making sufficient contact with
the tissues of the affected area. Stoppage resulting from "tissue
flow" into the perforations may occur and, if severe enough, may
necessitate surgical removal of the suppository. Another
suppository utilizes a cotton wad to form a base portion. Such
wads, however, can be unsatisfactory in that the tissues of the
anal verge become chafed from unlubricated portions of the wad
which exist because lubricants do not satisfactorily seep through
the wad.
In accordance with the above background of the invention, it is an
object of the present invention to provide a device for applying
medicine to the anal canal which overcomes the above-described
problems attendent prior art devices.
SUMMARY OF THE INVENTION
The present invention includes two smooth-surfaced, body
indissolvable bulbs approximately spherical or ellipsoidal in shape
secured together by a body-indissolvable connecting member. The
cross sectional area of the connecting member combined with any
medication which may surround it is less than the combined cross
sectional area of the bulbs and any medication which may surround
them, so that when the suppository is inserted into the anal canal,
the bulbs at each end straddle the anal sphincter muscles. More
particularly, one bulb is located adjacent the upper ends of the
Crypts of Morgagni in the rectal ampulla and the other is located
snugly in the anal verge.
The various embodiments and variations of the invention include use
of pathogenically inert materials, bulbs and connecting members of
various characteristics such as hollow or solid, rigid or flexible,
absorbing or non-absorbing and constructed in accordance with a
number of manufacturing techniques.
The foregoing and other objectives, features and advantages of the
invention will be apparent from the following more particular
description of the preferred embodiments of the invention as
illustrated in the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1(a) depicts an embodiment of the present invention wherein
indissolvable spheres, such as cotton or plastic, are fixed on
either end of a connecting shaft.
FIG. 1(b) depicts the device of FIG. 1 with further medication
shown in place in partial cross-section.
FIG. 2 depicts a partial sectional view of a device in which the
bulbs and connecting member are formed from a single piece of
plastic such as by molding.
FIG. 3 depicts a variation of the FIG. 1 device in which the
connecting member is a hollow, flexible tube adapted to receive a
rigid insertion member through a hole in one of the bulbs.
FIG. 4 depicts an embodiment wherein the connecting member of the
FIG. 1 device includes a plurality of smaller bulbs or enlargements
between the two end bulbs.
FIG. 5 depicts an embodiment of the invention in which two
indissolvable bulbs are affixed together by a flexible thread.
FIG. 6 depicts an embodiment of the invention in which one or more
smaller bulb members or enlargements are attached to an extension
of the connecting member on a side of one of the two bulbs remote
from the other bulb.
FIG. 7 depicts an embodiment in which a rigid insertion member
connects through at least one of the bulbs parallel to the
interconnecting thread.
FIG. 8(a) depicts an embodiment of the invention wherein the
connecting member is an elastic shown in the contracted
position.
FIG. 8(b) depicts the device of FIG. 8(a) wherein the elastic is
extended.
FIG. 9 depicts a suppository wherein the bulbs and connecting
member are hollow and permeable.
FIG. 10 depicts a suppository with wad of absorbant material
connected to the extra-corporeal bulb for the purpose of absorbing
excess medication.
FIG. 11 depicts a suppository with cotton spun at each end with the
outermost portion of one bulb uncoated for the purpose of absorbing
excess dissolved medicaments.
FIG. 12 depicts a suppository with an increased amount of
medication adjacent the inserted bulb.
DETAILED DESCRIPTION
With reference to FIG. 1(a), a device 1, in accordance with the
present invention, is shown. Device 1 includes a first bulb 2
generally in the form of a sphere connected by a connecting member
4 to a second bulb 3 also generally in the form of a sphere. The
bulbs 2 and 3 vary in size depending upon the animal or human in
which they are to be used. For the typical adult human, the bulbs
range approximately from 3/4 to 3/8 inch in diameter.
In FIG. 1(b), device 1 is shown with medication 6, shown in partial
cross-section, surrounding the connecting member 4. The
cross-sectional area of the connecting member 4 together with the
medication 6 is less than the cross-sectional area of either bulbs
2 or 3. In use, the device 1 with or without appropriate medication
6 is inserted through the anal opening (not shown) to a point where
the portion of bulb 3 nearest the connecting member 4 engages the
anal sphincter (not shown) thereby preventing the action of the
sphincter muscle from propelling the whole device 1 upwardly into
the lower rectum. With the bulb 3 held against the sphincter muscle
in the manner indicated, the bulb 2 becomes engaged above the anal
sphincter in the area of the crypts of Morgagni, thereby helping to
prevent device 1 from being propelled downwardly and out of the
body.
With the bulbs 2 and 3 positioned in this manner, the connecting
member 4 and medication 6 are positioned in the anal canal from the
anal verge, along the interior walls of the anal canal to the
rectal ampulla.
The medication 6 is typically of a body dissolvable type which acts
to slowly dissolve either as a result of contact with body fluid or
as a result of the temperature of the body. Typical medications of
that type are formulated with a polyethylene glycol base which acts
as a vehicle for dispersing the active medication employed.
In one preferred embodiment of the present invention, the
connecting member 4 is a stick, either flexible or semi-rigid, of
plastic or plastic coated paper approximately 0.050 inch in
diameter and the bulbs 2 and 3 are spherically-shaped balls of
cotton approximately 0.5 inch in diameter. Balls 2 and 3, for
example, are formed by spinning cotton onto each end of stick 4.
Cotton is initially anchored to each end of stick 4 being spinning.
The anchoring is typically achieved at each end using bonding
cement or by heat plasticizing the ends of the stick 4. After
anchoring and during the spinning, the cotton is bound to itself
through impregnation using, for example, resins. Other materials
such as latexes and sizing compounds may, of course, also be used.
Each cotton bulb is subsequently coated with a resin or other
materials like those indicated to provide a smooth, lubricated
surface that is compatible with and non-irritating to the delicate
tissues of the anal tract. The connecting member 4 is thereafter
surrounded by a slowly dissolving solid suppository base 6 which
contains medicaments which are like those used in conventional
hemorrhoidal suppositories known in the prior art. The medicament
is carried in a suppository base which acts as a vehicle for
imparting sustained medication to the affected parts over a period
of hours while melting slowly. Examples of suitable suppository
bases include polyethylene glycols, glycerogelatins, gelatins,
waxes, modified fats and fatty oils; but, of course, similar
materials may be employed.
The general spheriodal shape, the firmness and the smooth surface
of the bulbs 2 and 3 contribute to the effectiveness of the
suppository of the present invention. Specifically, the smooth
surface of the extra-corporeal bulb (either bulb 2 or 3) allows it
to be enveloped comfortably in the cleavage of the buttocks so as
to be seated snugly into and against the anal verge. The
extra-corporeal bulb is maintained in that position both by the
upward push of the sphincter muscle against the inserted bulb and
by the upward forces resulting from the pressure of the
buttocks.
The smooth, convex surface of the extra-corporeal bulb together
with its lubricating coating (e.g., wax, plastic, rubber) assures
that its contact with the tender affected anal parts will be
non-irritating even over a prolonged period of time, particularly
when part or all of the medicaments have been dissolved. These
surface characteristics of the present invention give rise to a
lubricous contact between the suppository and the body which is in
contrast to the irritating effects of the suppositories having
metal or rubber flanges or uncoated textured cotton surfaces.
In accordance with another feature of the present invention, the
upper surface of the extra-corporeal bulb (when in position) gives
prolonged support to affected parts which otherwise tend to
prolapse downward and tend to be prevented from returning upward by
the anal sphincter muscles, especially if these muscles are in
spasm. In conjunction with this prolonged support, the constant
presence of the suppository in the anal canal tends to stimulate
nerves in the area which allow the sphincter muscles to relax. This
stimulation together with any pain-relieving effects of the
medication combine to help overcome proctospasm which is a major
malevolent factor in the treatment of hemorrhoids.
The inner (inserted or inter-corporeal) bulb is similar to the
extra-corporeal bulb in being generally spheroidal in shape with a
lubricous, pathogenically inert surface insuring non-irritating
contact with the tissues above the anal sphincter muscles. The size
of the inner bulb (3/4 to 3/8 inch) while being sufficiently large
enough to prevent, generally, expulsion of the suppository during
normal body movements, even during slight voluntary relaxation of
the anal sphincter by the patient, is also sufficiently small
enough to afford comfortable expulsion during bowel movements or
manual removal by the patient.
As previously described, one preferred embodiment of the present
invention includes body-indissolvable bulbs 2 and 3 of spun cotton.
In another preferred embodiment, the bulbs 2 and 3 are plastic. The
plastic bulbs are attached to the previously described stick-like
connecting member 4, for example, by cement or heat welding. The
medication is located between the bulbs in the same manner as shown
and described above in connection with FIG. 1(b).
FIG. 2 depicts another embodiment of the present invention wherein
bulbs 2 and 3 and the connecting member 4 are one solid, continuous
piece of plastic, such as formed, for example, by injection
molding. Medication 6 is included as in FIG. 1(b).
Referring to FIG. 3, another embodiment of the invention is
depicted in which body-indissolvable bulbs 12 and 13 are connected
by a tubular member 14 which has a hollow center 17. Tube 14 is
typically injection molded together with bulbs 12 and 13 or
alternatively is connected to those bulbs by conventional methods
such as welding when heat formable plastics are used. The hollow
center 17 extends through the bulb 13 providing an opening 18 for
receiving a rigid insertion member 19. Insertion member 19 extends
through the bulb 13 and member 14 terminating in the vicinity of
bulb 12. Member 19 is made of a strong, rigid material such as
metal or hard plastic and functions to add rigidity to the device
of FIG. 3, particularly during insertion. The insertion member 19
is readily extracted and may be discarded, for example, after
insertion in the body.
Bulb 12 in FIG. 3 is shaped with a conical end 12' as an aid to
easy insertion. In addition to the conical shape, spherical or
other bulb-like shapes, of course, can be employed. Like the device
of FIG. 1, the bulbs 12 and 13 of FIG. 3 may be formed of any body
indissolvable material.
Referring to FIG. 4, an embodiment of the invention is shown
wherein the body-indissolvable bulbs 22 and 23 are connected by a
connecting shaft 24 which includes one or more interior bulbs 28.
Bulbs 28 together with the medicine 26 serve the dual functions of
aiding the adhesion of the medicine to the connecting member 24
while also helping to prevent the propulsion of the suppository
either upwardly into the rectum or downwardly out of the body. The
medicine 26 and connecting member 24 including the balls 28 have,
as in the other embodiments of the invention, a smaller
cross-sectional area than do the bulbs 22 and 23.
Referring to FIG. 5, an embodiment of the invention is shown in
which the bulbs 32 and 33 have a connecting member 34 in the form
of a thread, typically made of nylon. Thread 34 supports the
medication 36 between bulbs 32 and 33. Thread 34 is attached, for
example, to the bulbs 32 and 34 by means of knots 38 and 39 on
either sides of the bulbs, respectively. Further, the connecting
member 34 after extending through bulb 32 continues after one of
the knots 39 with a tail portion 40. The device of FIG. 5 is
adapted for insertion of bulb 32 into the body. When it is desired
to remove the suppository, the tail portion 40 provides a
convenient cord to effect removal. The tail 40, of course, need not
be employed if not desired.
Referring to FIG. 6, an embodiment similar to that of FIG. 5 is
shown where in FIG. 6, the spherical balls 42 and 43 are connected
by a thread 44 around which is secured the medicine 46.
Additionally, the thread 44 also extends from the opposite side of
ball 42 where it secures two additional smaller size balls 48 and
48'. The balls 48 and 48' support the conical shaped medicine 46'
which in addition to increasing medication functions to aid in the
insertion of the FIG. 6 device in the same manner as the conical
shape of the FIG. 3 device aids in its insertion.
Referring to FIG. 7, a variation of the FIG. 3 device is shown. In
FIG. 7, the bulbs 52 and 53 are separated by the medicine 56 around
the connecting thread 54. Juxtiposed the thread 54 is a rigid
insertion member 59 analogous to insertion member 19 of FIG. 3,
which imparts rigidity to the FIG. 7 device, particularly during
insertion. Member 59 may be readily extracted after insertion of
the FIG. 7 device and thereafter discarded. Also note in connection
with FIG. 7 that the medicine 56 may be extended in shallow layers
56' and 56" around the bulbs 52 and 53, respectively.
Referring to FIG. 8(a), an elastic embodiment of the present
invention is depicted. In FIG. 8(a), the connecting member 64 is an
elastic thread which supports the medicine 66 as shown in the
relaxed, short condition. In FIG. 8(b), the connecting member 64 is
shown in the tensioned, long condition (somewhat exaggerated for
clarity). In one embodiment, the extension beyond the relaxed
position is approximately 1/2 inch for a tensioning force of 2
pounds.
In FIG. 8(a) and FIG. 8(b), a ball 68 is connected to the elastic
member 64 in order to impede travel of the medication 66 along the
thread 64 particularly during insertion and in the extended
condition of FIG. 8(b). Knots 70, or other terminators, are located
to secure thread 64 to balls 62 and 63.
Referring to FIG. 9, a suppository having a permeable wall is shown
in accordance with another embodiment of the present invention. In
FIG. 9, this suppository includes bulbs 72 and 73 connected
together by a hollow tubular connecting member 74. The bulb-like
ends 72 and 73 and the connecting member 74 enclose a hollow
central cavity 75. Cavity 75 includes the medication which operates
to seep through the walls of the bulbs 72 and 73 as well as the
connecting member 74. Accordingly, the wall portions of the entire
device of FIG. 9 are permeable to the medication contained within
the cavity 75. For example, a polyethylene plastic having punctures
therein is one example of a suitably permeable material.
Referring to FIG. 10, a suppository similar to that shown in FIG. 5
is depicted which additionally includes a swab 76 formed of soft
cotton or other absorbing material. Swab 76 is attached to the bulb
33, in the embodiment of FIG. 10, by the connecting thread 34 and
the knot 78. The function of the swab 76 is to collect and absorb
excretions.
Referring to FIG. 11, a suppository like that depicted in FIG. 1(b)
is shown wherein the bulb 82 is like bulb 2 and is formed by
spinning cotton techniques. Similarly, the bulb-like element 83 is
also cotton or other absorbing material, but it is not spun into a
relatively hard-surfaced bulb-like bulb 82, but rather is
loose-textured like the swab 76 in FIG. 10. The medication 86 is
located between the bulb-like structures 82 and 83 in the same
manner as in FIG. 1(b).
Referring to FIG. 12, the suppository of the general type shown in
FIG. 2 is depicted wherein additional medication 96, is formed and
located on the side of bulb 92 opposite the connecting member 94.
In the device of FIG. 12, the bulbs 92 and 93, connected by
connecting member 94 function in the same manner as previously
described in connection with FIG. 2. The medication 96 located as
shown in FIG. 12 when inserted into the body extends further up
into the rectal canal.
While various features of the present invention have been disclosed
in connection with one or more embodiments of the invention,
various combinations of features can be used on any embodiment in
accordance with the present invention.
While the invention has been particularly shown and described with
reference to preferred embodiments thereof, it will be understood
by those skilled in the art that the foregoing and other changes in
form and details may be made therein without departing from the
spirit and the scope of the invention.
* * * * *