U.S. patent application number 10/781043 was filed with the patent office on 2005-08-18 for anal hygienic pad and method of use.
This patent application is currently assigned to A-Fem Medical Corporation. Invention is credited to Fleming, William H..
Application Number | 20050182376 10/781043 |
Document ID | / |
Family ID | 34838676 |
Filed Date | 2005-08-18 |
United States Patent
Application |
20050182376 |
Kind Code |
A1 |
Fleming, William H. |
August 18, 2005 |
Anal hygienic pad and method of use
Abstract
A method is disclosed for absorbing anal leakage, such as fecal
material, blood or flatulence. The method includes positioning an
intergluteal absorbent pad external to the anal orifice of a
subject such that the pad is retained between the buttocks, and any
discharge from the anus is absorbed by the absorbent material of
the pad. The pad has a smaller minor portion superimposed on a
larger major portion, and the smaller minor portion is inserted as
a leading edge between the gluteals of the subject to facilitate
insertion by gradually moving the gluteals apart. The smaller minor
portion of the pad is positioned against the anal orifice to
minimize pressure exerted in this sensitive area, while the larger
major portion is retained in the less sensitive intergluteal space.
The major portion conforms to the soft tissue of the gluteals, and
is large enough to help retain the pad frictionally in place
without any adhesive or garment to hold it in place. The pad can
have a variety of shapes, including major and minor portions that
are portions of spheres or ellipsoids, or which are elongated and
have cross-sections that are circular or ellipsoid. Insertion and
retention of the pad adjacent to the anus helps alleviate symptoms
of the hemorrhoids, absorbs leakage (such as fecal material or
medication), and can also be used as a reservoir to administer
medication.
Inventors: |
Fleming, William H.;
(Tualatin, OR) |
Correspondence
Address: |
KLARQUIST SPARKMAN, LLP
121 SW SALMON STREET
SUITE 1600
PORTLAND
OR
97204
US
|
Assignee: |
A-Fem Medical Corporation
|
Family ID: |
34838676 |
Appl. No.: |
10/781043 |
Filed: |
February 17, 2004 |
Current U.S.
Class: |
604/385.01 |
Current CPC
Class: |
A61F 13/47209
20130101 |
Class at
Publication: |
604/385.01 |
International
Class: |
A61F 013/15; A61F
013/20 |
Claims
We claim:
1. A method for absorbing leakage from an anus of a subject,
comprising positioning an intergluteal absorbent pad external to
the subject's anal orifice such that the pad is retained between
the buttocks, so that discharge from the anus is absorbed by the
absorbent material of the pad.
2. The method of claim 1, wherein the pad is held between the
buttocks without adhesives or attachment to a supporting
garment.
3. The method of claim 1, wherein the absorbent material is a
highly absorbent non-swellable material.
4. The method of claim 1, wherein the pad has a uniform
cross-section along its entire length or is tapered along its
length.
5. The method of claim 1, wherein the pad has a minor portion
superimposed on a major portion, the minor portion having a
cross-sectional area smaller than a cross-sectional are of the
major portion and wherein the minor portion is tapered to
facilitate insertion between the subject's gluteals and retention
in the intergluteal space, and a portion of the minor portion is
positioned against the subject's anus.
6. The method of claim 5, wherein the minor an major portions of
the pad have a elliptical cross-section with a major axis, wherein
the major axis of the minor portion is less than the major axis of
the major portion.
7. The method of claim 1, wherein the pad includes an agent for
absorbing odors.
8. The method of claim 1, wherein the pad carries a therapeutically
effective amount of a medicinal agent to be dispensed from the pad,
and the subject is a subject in need of the medicinal agent.
9. The method of claim 8, wherein the medicinal agent is an
anesthetic or a lubricant.
10. The method of claim 1 wherein the pad is placed between the
buttocks of the subject to absorb excess leakage from the anus, and
wherein the leakage comprises fecal material, glandular secretions,
and/or blood.
11. The method of claim 1, wherein the pad is placed between the
buttocks of the subject to absorb excess suppository leakage,
flatulence, hemorrhoid bleeding, fissure bleeding, or fecal
incontinence.
12. The method of claim 1, wherein the pad is placed external to
the anal sphincter, against the anal orifice.
13. The method of claim 1, wherein the pad has a tapered leading
edge that is inserted between the subject's buttocks to push the
buttocks apart as the leading edge of the pad is inserted between
the buttocks.
14. The method of claim 13, wherein the tapered leading edge is
positioned against the anal orifice, and a remainder of the pad has
a width which is wider than a normal anatomic intergluteal space,
such that the remainder of the pad is frictionally engaged and
retained by opposing gluteals.
15. The method of claim 14, wherein the pad is elongated and
positioned adjacent and external to the anal orifice but not a
vaginal orifice.
16. The method of claim 1, further comprising performing a
diagnostic test on the discharge from the anus.
17. The method of claim 16, wherein the diagnostic test is an
analysis of occult blood in a discharge including stool.
18. A method for absorbing leakage from a subject's anus,
comprising inserting a pad into the subject's intergluteal space,
positioning the pad adjacent to the subject's external anal
orifice, such that leakage from the subject's anus is absorbed by
the pad, wherein the pad is devoid of corners and flat surfaces
intermediate its ends, and the pad has a minor portion superimposed
on a major portion, the minor portion having a cross-sectional area
smaller than a cross-sectional area of the major portion, wherein
both the minor and the major portion are curvilinear in
cross-section, and wherein the minor portion facilitates insertion
between the subject's buttocks and retention in the anal space.
19. The method of claim 18, wherein the pad includes a medicinal
aor odor-absorbing agent.
20. The method of claim 18, wherein the pad is elongated and has a
uniform cross-section along its entire length, or is tapered along
its length.
21. The method of claim 20, wherein the pad is elongated, and, when
placed in the intergluteal space, extends external to the anal
orifice an a vaginal opening to absorb leakage from the vagina in
addition to leakage from the anus.
22. The method of claim 18, wherein the pad carries a
therapeutically effective amount of a medicinal agent, and
positioning the pad comprises administering the medicinal agent to
the subject.
23. The method of claim 22, wherein the medicinal agent is an
anesthetic or a lubricant.
24. The method of claim 18, wherein the pad is placed between the
buttocks of the subject to absorb excess leakage from the anus, and
wherein the leakage comprises fecal material, glandular secretions,
and/or blood.
25. The method of claim 18, wherein the pad is placed between the
buttocks of the subject to absorb excess suppository leakage,
flatulence, hemorrhoid bleeding, fissure bleeding, or fecal
incontinence.
26. The method of claim 18, wherein the pad is placed external to
the anal sphincter.
27. The method of claim 18, wherein the pad has a tapered leading
edge that is inserted between the subject's buttocks to push the
buttocks apart as the leading edge of the pad is inserted between
the buttocks.
28. The method of claim 27, wherein the tapered leading edge is
positioned against the anal orifice, and a remainder of the pad has
a width which is wider than a normal anatomic intergluteal space,
such that the remainder of the pad is frictionally engaged and
retained by opposing gluteals.
29. The method of claim 18, further comprising performing a
diagnostic test on the discharge from the anus.
30. The method of claim 29, wherein the diagnostic test is an
analysis of occult blood in a discharge including stool.
31. A method for treating a symptom of a subject with hemorrhoids,
comprising positioning an intergluteal elongated absorbent pad such
that the pad is retained between the buttocks external to the
subject's anus, wherein the pad comprises a longitudinally
extending major portion and a longitudinally extending minor
portion integrated with the posterior portion, wherein the minor
portion has a smaller transverse section diameter relative to the
larger transverse section diameter of the major portion, wherein
the minor portion is designed for insertion of the pad between the
subject's buttocks in the anatomic intergluteal space adjacent to
the anus, and the major portion is attached to the anterior portion
such that is retained between the buttocks, wherein insertion and
retention of the pad adjacent to the anus alleviates a symptom of
the hemorrhoids.
32. The method of claim 31, wherein the minor and major portions of
the pad have a length greater than their width, and the shape of
the pad substantially conforms to the intergluteal space in which
the pad is retained.
33. The method of claim 31, wherein the pad is held between the
buttocks without adhesives or attachment to a supporting
garment.
34. The method of claim 31, wherein the major portion of the pad
has longitudinally extending, opposed, substantially parallel face
portions.
35. The method of claim 31, wherein the minor portion of the pad
has longitudinally extending, opposed substantially parallel face
portions.
36. The method of claim 35, wherein the opposed flat face portions
of the pad are substantially parallel.
37. The method of claim 35, wherein the opposed flat face portions
of the pad are substantially convergent.
38. The method of claim 31, wherein the minor portion of the pad
has longitudinally extending, opposed substantially parallel face
portions.
39. The method of claim 38, wherein the opposed flat face portions
of the pad are substantially parallel.
40. The method of claim 38, wherein the opposed flat face portions
of the pad are substantially convergent.
41. The method of claim 31, wherein the minor and major portions of
the pad have a shoulder shaped junction.
42. The method of claim 31, wherein the pad carries a
therapeutically effective amount of a medicinal agent, and
positioning the pad comprises administering the medicinal agent to
the subject.
43. The method of claim 42, wherein the medicinal agent is an
anesthetic or a lubricant.
44. The method of claim 1, wherein the pad includes a cavity in
which a medicinal agent is placed prior to positioning the pad.
45. The method of claim 44, wherein the cavity is compressed
between the buttocks when the pad is positioned.
46. The method of claim 45, wherein the cavity communicates with an
exterior surface of the pad.
47. The method of claim 46, wherein the cavity is a recess in an
exterior surface of the pad.
48. The method of claim 44, wherein the pad is elongated, and the
cavity extends longitudinally along the pad.
Description
FIELD OF THE INVENTION
[0001] This invention relates to the field of anal incontinence,
more specifically to a device for absorbing anal leakage or other
discharges.
BACKGROUND OF THE INVENTION
[0002] Hemorrhoids are varicosities of anal veins which are common
following pregnancy, as one ages, or as a result of a more
sedentary lifestyle. Those suffering from hemorrhoids are often not
able to use common suppositories or cremes for the relief of
itching or pain during the day, because suppositories or cremes can
leak during ambulation or when it is not possible to remain supine.
Hemorrhoids can also bleed or result in a mucus discharge that can
stain clothing. Although any resulting anal discharge (which may
include feculent material) may be in small amounts, it can be
hygienically and emotionally distressing.
[0003] Anal incontinence (the loss of feces and contaminated
moisture) or loss of blood from hemorrhoids or anal fissures, are
common problems, particularly with activities such as jumping or
running. Fecal incontinence can result from disease, such as nerve
compression, impairment or degeneration; iatrogenic causes such as
radical surgery in the lower spine or rectal zone of the body;
spinal cord injuries; or advancing age.
[0004] The loss of even small amounts of discharge from the anus
may give rise to a pungent and abhorrent odor, accompanied by a
feeling of wetness and/or irritation. Anal incontinence may lead to
the development of other diseases due to the bacteria laden moist
environment created by this leakage.
[0005] Other exudations that may be encountered include anal
secretions, such as secretions derived from Skene's and Bartholin's
glands, sweat glands, and the like. Such secretions and exudations
may mix to produce disagreeable odors, and may be accompanied by an
uncomfortable feeling of wetness. This phenomenon becomes more
pronounced in the case of a person having a discharge due to
infection or venereal disease, or postoperative, post-delivery or
hemorrhoidal inflammation.
[0006] Many people who suffer from anal incontinence wear large
diapers and/or plastic or rubber undergarments such as are
disclosed in U.S. Pat. No. 5,699,902. In addition, hygienic
articles have been developed which are inserted into and retained
within the anal sphincter to absorb rectal secretions (e.g. U.S.
Pat. No. 4,804,380), or which are fixed to the natal cleft by an
adhesive (e.g. U.S Pat. No. 5,695,484). However, there remains a
need for a comfortable, non-intrusive device, for those who suffer
from anal incontinence, that can absorb anal or peri-anal
secretions.
SUMMARY OF THE INVENTION
[0007] An absorbent pad has been designed which can be located
external to the anal orifice to collect any anal discharge. The pad
can be retained in the intergluteal space, between the buttocks,
without the use of a supporting garment or adhesive. In particular
embodiments, the pad is positioned external to the external anal
sphincter, so that it is not retained by insertion in the anus.
[0008] The pad is used in a method of absorbing anal leakage in a
subject by positioning the absorbent pad between the buttocks,
external to the subject's anal orifice, such that the pad is
retained between and by the buttocks. In this position, any anal or
peri-anal discharge is absorbed by the pad. In particular
embodiments of this method, the pad is devoid of corners and flat
surfaces intermediate its ends, and the pad has a minor portion
superimposed on a major portion. The minor portion of the pad has a
cross-sectional area or width that is smaller than a
cross-sectional area or width of the major portion, and both the
minor and the major portions are curvilinear or partially
cylindrical in cross-section. The reduced width minor portion
facilitates insertion of the pad between the subject's buttocks,
separation of the buttocks, and placement of the smaller portion
adjacent the anal orifice. The larger major portion is not as close
to the sensitive anal orifice, which avoids discomfort caused by
the pressure exerted by the larger portion. However the larger
portion is more readily frictionally retained between the buttocks,
in the intergluteal space, without external attachment devices such
as adhesive. In particular embodiments, a method is disclosed for
treating hemorrhoids by inserting the pad between the buttocks,
against the external anal orifice.
[0009] In some embodiments, the method delivers therapeutic
substances (such as antibiotics, topical anesthetics or topical
vasoconstrictors), for example in the treatment of hemorrhoids. The
method includes positioning the intergluteal pad such that the pad
is retained between the buttocks external to the subject's anus.
The anterior portion of the pad is designed for insertion of the
pad between the subject's buttocks in the anatomic intergluteal
space adjacent to the anus, and the posterior portion is retained
between the buttocks without the need for adhesive or other
attachment devices. Insertion and retention of the pad adjacent to
the anus alleviates one or more symptom of the hemorrhoids, or
delivers drugs to the anal orifice.
[0010] The pad can be any of a variety of shapes, and particularly
shapes which taper toward an anterior or leading edge of the pad.
The anterior edge is usually sufficiently wide to be retained
outside the anal orifice, but can be sufficiently narrow to extend
at least partially within the anus (for example external to the
anal valve). The pad is ideally substantially or completely
retained exterior to the anus, with the posterior edge impinging
against the surrounding buttocks to retain the pad in place. The
pad can be symmetric or asymmetric, rounded or elongated, tapering
or non-tapering. However particular embodiments taper from a
relatively larger posterior portion to a relatively smaller
anterior portion. The enlarged posterior portion is ideally large
enough to at least slightly deform the surrounding buttocks to
improve frictional engagement between the buttocks and the pad. The
relatively small anterior portion is closer to the width of the
anal orifice, and is more comfortably retained in the narrow
intergluteal space adjacent the anus. The pads with a bipartite
structure (with a major and minor portion) further enhance the
comfort and retention of the pad.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] FIG. 1 is a schematic posterior view of the buttocks and
thighs of a female subject in whom an absorbent pad has been
positioned external to the anal orifice to collect discharge from
the anus. The pad is shown retained in the intergluteal space,
between the buttocks, without the use of a supporting garment or
adhesive. The position of the pad is indicated by dashed lines.
[0012] FIG. 2 is a cross-sectional sagittal view taken along line
2-2 of FIG. 1, showing a pad positioned adjacent the anal
orifice.
[0013] FIG. 3 is a horizontal sectional view of the anus and
buttocks, showing the position of an anal pad external to the anal
sphincter, with an enlarge posterior portion of the pad slightly
deforming the buttocks to retain the pad in place.
[0014] FIG. 4 is a cross sectional fragmentary view of an
intergluteal absorbent pad of the invention.
[0015] FIGS. 5-9 are views similar to FIG. 4, but showing different
embodiments of the pad which have a substantially quadrilateral
shape.
[0016] FIGS. 10 and 11 are cross sectional views of the major
portion of the pad, showing the major portion to be either arcuate
(FIG. 10) or tapered (FIG. 11).
[0017] FIG. 12 is a cross sectional view of an intergluteal
absorbent pad that does not have a major portion and a minor
portion, but which has the side surfaces of the pad sloping toward
a leading edge of the pad.
[0018] FIGS. 13-15 are cross-sectional fragmentary views showing
pads which have major portions that are polygonal in shape.
[0019] FIGS. 16 is a cross sectional view of an elongated
intergluteal absorbent pad with a major portion and a minor
portion, both of which taper symmetrically in a longitudinal
direction.
[0020] FIG. 17 is a view similar to FIG. 16, but showing the major
and minor portions of the pad tapering longitudinally in different
directions.
[0021] FIG. 18 is a perspective view of an elongated intergluteal
absorbent pad that has a fixed diameter along the length of the
pad.
[0022] FIGS. 19-21 are side views of intergluteal absorbent pads
similar to the pad shown in FIGS. 18, but with one or two sloping
end edges.
[0023] FIG. 22 is a cross sectional view of an intergluteal
absorbent pad wherein the posterior portion of the pad is formed
with a longitudinal groove.
[0024] FIG. 23 is a cross sectional view of the intergluteal
absorbent pad of FIG. 22 disposed between the buttocks in the
intergluteal space.
[0025] FIG. 24 is a cross sectional view of a unitary, one-piece
yet bipartite intergluteal absorbent pad in which each portion of
the pad has a cross section of a portion of a circle, each circle
having different radii of curvature. FIG. 25 is a cross sectional
view of a bipartite pad in which each portion of the pad has a
cross section of a partial ellipse. The pads may be either
symmetric or asymmetric. In the symmetric embodiment, the major and
minor portions may have the shape of partial spheres or
ellipsoids.
[0026] FIG. 26 is a cross sectional view of an additional
embodiment of a one-piece intergluteal pad with an elliptical cross
section, and no minor and major portions.
[0027] FIG. 27 is an end perspective view of an elongated pad with
a minor and a major portion that extends along its length, and a
groove in the minor portion from which drugs or other agents can be
released by compression of the pad in use.
[0028] FIG. 28 is an end view of the pad of FIG. 27.
[0029] FIG. 29 is a perspective view of an elongated pad.
[0030] FIG. 30 is a perspective view of another embodiment of a
folded pad for placement in the gluteal fold.
[0031] FIG. 31 is a view taken along lines 30-30 of FIG. 30.
DESCRIPTION OF MULTIPLE SPECIFIC EMBODIMENTS
[0032] The following definitions and methods are provided to better
define the present invention and to guide those of ordinary skill
in the art in the practice of the invention. As used herein and in
the appended claims, the singular forms "a", "an", and "the"
include plural referents unless the context clearly dictates
otherwise. Thus, for example, reference to "a discharge" includes a
plurality of such discharges and reference to "the absorbent
material" includes reference to one or more materials and
equivalents thereof known to those skilled in the art, and so
forth.
[0033] Unless defined otherwise, all technical and scientific terms
used herein have the same meaning as commonly understood to one of
ordinary skill in the art to which this invention belongs.
DEFINITIONS
[0034] Absorbent: A material with sufficient absorbency to absorb
and retain exudates discharged from a subject. Absorbency is
dependent partially on the physical volume of the device. For
example, a material is absorbent if it absorbs at least 3 ml of
0.9% saline, however an absorbent material may have a capacity of
20 grams or more.
[0035] Anal Leakage: Discharge from the anus, including involuntary
discharges. Anal leakage can be fecal material, blood or
secretions, or leakage of a medicinal agent placed into the anal
canal, such as when a suppository is inserted rectally.
[0036] Anal sphincter: A circular layer of muscle in the anal
canal. The circular coat is thickened at the upper end of the anal
canal and forms the involuntary internal sphincter. The internal
sphincter is surrounded by a sheath of striated muscle that forms
the voluntary external sphincter. At the junction of the rectum and
anal canal the blending of the internal sphincter with the deep
part of the external sphincter and the puborectais muscles forms a
distinct ring, called the anal rectal ring.
[0037] Anal Triangle: A region bounded behind by the tip of the
coccyx, and on each side, by the ischial tuberosity and the
sacrotuberous ligament, overlapped by the border of the gluteus
maximus muscle. The anus lies in the midline, and on each side
there is the ischiorectal fossia.
[0038] Anus or Anal Orifice: the lower opening of the anal canal.
The anal canal is about 4 cm long and passes downward and backward
from the rectal ampulla to the anus. Except during defecation, its
lateral walls are kept in apposition by the levaotres ani muscles
and the anal sphincters. The mucous membrane of the upper half of
the anal canal is derived from endoderm, is sensitive to stretch,
and is lined by vertical folds called anal columns which are joined
together at their lower ends by semi-lunar folds called anal
valves. The mucous membrane of the lower half of the anal canal
(external to the anal valves) is derived from ectoderm, has no anal
columns, and is extremely sensitive to pain.
[0039] Biodegradable material: A material having greater than or
equal to about 70% biodegradation (percentage of theoretical carbon
dioxide evolution) after 28 days when measured by a suitable test
such as the Sturm test (Method 301B, Organization of Economic
Cooperation and development).
[0040] Defecation: An act that results in the emptying of the
descending colon, rectum, and anal canal by reflex acts and/or
voluntary control of the anal sphincters.
[0041] Diagnostic test: Any procedure performed on a sample
collected from a subject, wherein the procedure can be used to
evaluate or monitor a disease or a disorder in the subject. A
diagnostic test can be performed in a laboratory, a medical office
or in the home environment.
[0042] Fecal incontinence: The involuntary discharge of fecal
material from the anus.
[0043] Flushable: A product's capacity to pass through typical
commercially available house toilets and plumbing drainage systems
without causing clogging or similar problems that can be directly
associated with the physical characteristics of the product.
[0044] Gluteal: The back of a hip that forms one of the fleshy
parts where a human sits, it is also known as a buttock.
[0045] Gluteal Region: An anatomical region bounded superiorly by
the iliac crest and inferiorly by the fold of the buttock. The
region is largely made up of the gluteal muscles and a thick layer
of superficial fascia.
[0046] Hemorrhoid: A mass of dilated veins in swollen tissue
situated near the anal sphincter.
[0047] Intergluteal space: The space located between the right and
left gluteals (buttocks), generally on a sagittal plane that
includes the anus. The intergluteal space extends inferiorly toward
the perineal body to the vaginal opening in the female (but does
not include the vaginal opening), and toward the scrotum in the
male (without including the scrotum).
[0048] The major portion of the pad is a larger portion, and a
minor portion is a smaller portion. Large and small can be defined,
for example, in terms of cross-sectional area, volume, or
transverse dimension. In some embodiments, the pad is inserted
between the gluteals with the minor portion as the leading edge
inserted, in which example the minor portion would also be
considered an anterior edge and the major portion would be a
posterior portion.
[0049] Medicinal Agent: A therapeutic agent for treatment of the
anal triangle. Specific, non-limiting examples of a medicinal agent
are anesthetics, antibiotics, deodorants, or lubricants.
[0050] Natal cleft: The cleft formed where the external surfaces of
the gluteals touch.
[0051] Occult blood: A diagnostic test performed to detect the
presence of blood in a stool (fecal) sample. A test for occult
blood is useful in the diagnosis of disease, such as colon
cancer.
[0052] Supporting garment: A garment such as a belt or article of
clothing, for example underwear, used to hold an absorbent pad in
place on or in the body, for example in the anal triangle.
[0053] Vaginal orifice: The opening at the distal end of the
vaginal canal.
[0054] Methods of Absorbing Leakage
Embodiment of FIGS. 1-3
[0055] A first embodiment of the invention is shown in FIGS. 1-3,
in which an absorbent pad 30 is shown in place external to the anal
orifice 32. The anal anatomy of a female is illustrated in these
drawings, which show the anal sphincter 34 which closes the anal
canal, and the anal valve 36 (FIG. 3) at the inferior aspect of the
anal columns 38. The distal region of the anal canal, particularly
inferior to the anal valve, is well innervated and exceedingly
sensitive to pain, itching, and other disease processes. Anterior
to the anal orifice 32 is the vaginal opening 40 and the urethral
opening 42. The right and left gluteals 46, 48 appose one another,
and generally form an intergluteal potential space 48 (FIGS. 1 and
3) that covers the anal orifice 32. This potential space can be
opened by moving the gluteals away from one another (as
particularly illustrated in FIG. 3).
[0056] In the embodiment disclosed in FIGS. 1-3, the pad 30 is an
elongated absorbent member, for example made of cotton, and having
a bipartite profile with a major portion 50 and a minor portion 52.
In the illustrated example, the major and minor portions each have
a cross section that is a portion of a circle, where the portion of
the circle of the major portion 50 has a greater diameter than the
portion of the circle of the minor portion 52. The curvature of the
minor portion is greater than the curvature of the major portion.
The overall shape of pad 30 therefore includes a rounded major
portion and a rounded minor portion, in which the transverse
diameter or width W1 (FIG. 3A) of the major portion is greater than
the transverse diameter or width W2 of the minor portion, so that
the width of pad 30 tapers in the direction of minor portion 52.
The width of major portion 50 is ideally greater than a diameter of
an average anal orifice 32 (for example as determined by population
studies), and minor portion 52 has a reduced width (and increased
taper) to minimize pressure and discomfort in the area of anal
orifice 32. The minimum width of minor portion 52 is, in some
embodiments, substantially the same or slightly less than the
maximum diameter of anal orifice 32. The outer profile of both the
major and minor portions is arcuate to help conform to surrounding
body tissues. The cross-sectional area of minor portion 52 in some
embodiments is less than 50% of the cross-sectional area of pad 30,
and has a cross-sectional area that is, for example, 10 to 49% of
the total cross-sectional area of pad 30.
[0057] The reduced width of minor portion 52 is also advantageous
for the insertion and retention of pad 30 in use. Gluteals 44, 46
are spread apart either by moving them apart, or by introducing the
reduced width minor portion 52 as a leading edge of the pad between
them, and advancing the pad toward anal orifice 32. As pad 30 is
inserted into intergluteal space 48, the leading minor portion 52
gradually moves gluteals 44, 46 apart (FIG. 3), to facilitate
acceptance of major portion 50. Once minor portion 52 is in place
against anal orifice 32, major portion 50 provides an enlarged
retention member that frictionally engages surrounding portions of
gluteals 44, 46 to retain pad 30 in position. In this position, pad
30 is able to absorb leakage or other discharges (such as feces or
even flatulence) from the anal orifice. The anal pad 30 is retained
by the buttocks, in the intergluteal space, and does not extend
beyond the natal cleft 32.
[0058] The pad is easily inserted between the buttocks and is
easily retained in the intergluteal space without the need for
auxiliary retaining means. Thus, a light pressure on the major
portion 50 will cause the smaller minor portion 52 to open the
buttocks slightly and allow pad 34 to take its proper position in
the intergluteal space overlying the anal orifice 36. The radii of
the respective portions is such that the anal orifice 36 is
completely covered by the pad. The elongated pad extends along the
intergluteal space 48, such that the length of the pad helps
frictionally engage the pad in place, and resist dislodgement.
[0059] In particular embodiments, the intergluteal absorbent pad is
formed of a soft absorptive material such as cellulose, cotton, or
another suitable natural or synthetic fiber or sheeting. In one
embodiment the pad is flushable, and can be made of biodegradable
material. The pad may be made as described in U.S. Pat. No.
5,575,047, herein incorporated by reference.
EXAMPLES OF ALTERNATIVE EMBODIMENTS OF PADS
[0060] Some other examples of alternative embodiments of the pad
with a tapering portion are shown in FIGS. 4-28. Many of these
embodiments are shown in cross-section as relatively flat, although
they can be elongated (as indicated by the fragmentary depiction in
each Figure).
[0061] In the embodiment shown in FIG. 4, a one piece absorptive
pad 58 has a "tear-drop" or ovoid cross sectional shape which
tapers progressively to a leading anterior edge portion 60 of
limited transverse dimension from a posterior portion 62 of
relatively large transverse dimension.
[0062] The pad 58 may be elongated transverse to the illustrated
cross-section, or it may not be elongated (such that the length of
the pad transverse to the cross section is less than the
anterior-posterior dimension A-P of the cross-section). In
elongated embodiments, the pad may be of uniform cross section
along the length thereof, or may be tapered from one end to the
other end thereof, and in particular embodiments is tapered in its
anterior-posterior dimension AP. The user may readily and quickly
insert the pad 58 into the intergluteal space by introducing
leading anterior portion 60 into the inter-gluteal space. The pad
is firmly self retained in the space and exhibits substantial
absorptive capacity for discharges, and resists accidental
dislodgement from the intergluteal space.
[0063] Other embodiments of the pad are shown which have posterior
major portions of a polygonal (for example quadrilateral) shape,
such as rectangular or square. Thus, as shown in FIG. 5, pad 62
includes a posterior portion 64 having flat bottom and side
surfaces; and the anterior minor portion 66 has surfaces 68 which
incline toward one another toward a leading edge 70. Anterior
portion 66 therefore forms a wedge that parts the gluteals as it is
introduced between them.
[0064] FIG. 6 shows a pad 72 that includes a posterior portion 74
of substantially square cross section; and a fingerlike anterior
portion 76 of limited transverse dimension, which is much narrower
than the corresponding transverse dimension of posterior portion
74. The juncture 78 of portions 74, 76 forms an essentially flat
shoulder that extends transverse to the anterior-posterior
dimension AP. In the disclosed embodiment, the anterior-posterior
dimension of anterior portion 76 is substantially the same as the
anterior-posterior dimension of posterior portion 74.
[0065] FIG. 7 shows a pad 80 that is similar to that of FIG. 8,
except that the sides of anterior portion 84 diverge away from top
edge 86, to present a more tapered profile. FIG. 8 shows a pad 88
having a posterior portion 90 and an anterior portion 92, wherein
both portions are substantially quadrilateral in shape, except for
a sloping flat shoulder 94 at the juncture of portions 90, 92. FIG.
9 shows a pad 95 that includes a posterior portion 96 of
quadrilateral shape and an anterior portion 98 having upwardly
converging side surfaces 100 and a flat leading edge 102.
[0066] While the pads shown in FIGS. 5-9 have posterior portions
with flat bottom surfaces, the bottom surfaces may have other
configurations. Thus, as shown in FIG. 10, the posterior portion P
has an arcuate bottom surface A, while in FIG. 11, the posterior
portion P' has converging surfaces C and an arcuate bottom edge
B.
[0067] Further, alternative embodiments are shown in FIGS. 12 and
13. Thus, in FIG. 12, the non-bipartite pad 104 is of generally
triangular cross section, with a posterior portion 106 of large
cross section and an anterior portion 108 of small cross section.
The pad 104 has flat, converging surfaces 110, a slightly curved
bottom surface 112, rounded bottom edges 114 and a rounded leading
edge 116. The pad 118 shown in FIG. 10 is similar to pad 106,
except that the anterior portion 120 is transversely constricted
and provides a linear juncture J between posterior portion 122 and
anterior portion 120. This is an example of a bipartite pad that
has major and minor portions.
[0068] FIG. 14 shows pad 124 which includes a posterior portion 126
of substantially hexagonal cross section and a transversely
constricted anterior portion 128 with a rounded leading edge 130.
The surfaces of posterior portion 126 are flat and edges thereof
may be rounded.
[0069] FIG. 15 shows pad 132 which includes a posterior major
portion 134 defined by opposed convergent flat surfaces 136 and a
slightly rounded bottom surface 138; while anterior minor portion
140 is of a triangular cross section.
[0070] The pads may be suitably tapered in a longitudinal direction
transverse to the AP direction. Thus pad 142, as shown in FIG. 16,
has its anterior portion 144 and posterior portion 146 tapered in
respect of both the longitudinal and transverse axes thereof;
whereas in pad 148, as shown in FIG. 17, anterior portion 150 and
posterior portion 152 are tapered longitudinally only.
[0071] FIG. 18 shows yet another embodiment of the pad 154, in
which the anterior portion 156 and posterior portion 158 are
substantially ovoid in cross-section, with the transverse width of
anterior portion 156 much less than the transverse width of
posterior portion 158.
[0072] The pads may be further modified, as shown in FIGS. 19-21.
Thus, as shown in FIG. 19, the pad 160 has its posterior portion
162 sloped at one end as at 164, to make the pad conform to the
anatomy of the user. Alternatively, as shown in FIG. 20, the pad
166 may be sloped at both opposite ends 168, 168'. Alternatively,
as shown in FIG. 21, pad 170 has its posterior portion 172 sloped
at opposite ends in a convergent configuration. If desired, in the
foregoing embodiments, the anterior portions of the pads may also
be sloped to converge toward one another.
[0073] FIG. 22 shows an embodiment of a pad 174 that has an
anterior portion 176 and posterior portion 177. The posterior
portion 177 is formed with a longitudinal groove 178 of normally
triangular section, forming wings 180. When the pad 174 is inserted
into the intergluteal space, as shown in FIG. 23, the wings 180 are
resiliently urged toward each other and bear against the walls of
the intergluteal space, adjacent to the buttocks, thereby
increasing the retention of the pad within the intergluteal
space.
[0074] The various forms of pads set forth above may also include
the groove in the anterior portions thereof. The pads set forth
above which have opposed flat surfaces (e.g. FIGS. 6-9), are
particularly adapted to conform to the walls defining the
intergluteal space, and optimize the retention and absorption
factors of the pads. Moreover, the grooves can be filled with
therapeutic or other substances, so that the pad becomes a delivery
vehicle.
[0075] Although some of the pads have been shown to taper
longitudinally from one end to the other end, they may also taper
from a central portion to the opposite ends thereof. Thus, while
the pad may be of uniform cross section throughout its length, it
may also have a tapered form. No string or other removal aid is
required, and the pad can be removed manually, such as with a
gentle tap, or removed by normal use of the toilet (for example by
defecation).
[0076] Another embodiment of the intergluteal absorbent pad 182 is
shown in FIG. 24, in which the intergluteal absorbent pad 182 has a
posterior portion 184 and anterior portion 186, each having a cross
section that defines a portion of a circle. Each of the posterior
and anterior portions is a portion of a sphere that is symmetric in
all directions with respect to a center point, and has a constant
radius. For example, posterior portion 184 is symmetric with
respect to center C1, while anterior portion 186 is symmetric with
respect to center C2.
[0077] FIG. 25 shows yet another embodiment of a pad 188 having
merged portions 190, 192 which are of part elliptical cross
section; the portion 190 having major and minor axes somewhat
larger then those of portion 192, which also lends itself to easy
insertion and removal. Portion 190 is symmetric in all directions
with respect to perpendicular planes of symmetry, one of which is
shown as P in FIG. 25. In this embodiment, the pad is not elongated
in any direction, although in other embodiments longitudinal
elongation is possible.
[0078] The pad 194, shown in FIG. 26, is of an elliptical cross
section. This embodiment lacks a major portion and a minor portion,
and instead has a cross-section that is completely symmetric with
respect to an anterior-posterior plane AP. In use, pad 194 is
inserted along the AP axis into the intergluteal space (either
narrowed end of the pad can be the leading edge of insertion).
[0079] The pad 190 shown in FIG. 27 is an elongated version of the
pad in FIG. 24 which has a more spherical configuration. Pad 190 in
FIG. 27 is initially of a round cross section, but is formed into a
larger and smaller portion by using a mechanical binding agent,
such as thread or heat welding, similar to that described in
Gerstenburger (U.S. Pat. No. 5,575,047). Alternatively, it can be
sewn along the junction between the two portions with biodegradable
thread, so that the pad is completely biodegradable, and can be
flushed down a toilet. Biodegradable pads can be made by any
method, such as those disclosed in U.S. Pat. No. 5,575,047, which
is incorporated herein by reference.
[0080] The absorbent pads used to absorb anal discharge may be
impregnated with selected scents, medications, or combinations
thereof to mask the odor of the absorbed discharges, thereby
providing a soothing and pleasant odor, and/or to provide
appropriate treatment to external hemorrhoids, active anal
fissures, traumatic, infectious or neoplastic lesions, or many
other pathologies and conditions. In one embodiment, the pad
includes activated charcoal, which may be used to absorb odors,
such as those associated with flatulence. In another embodiment,
the pad is impregnated in the posterior portion only. However, in
other embodiments, the pad is impregnated in the anterior portion,
or in both the anterior and posterior portions. In one embodiment,
the pad includes a groove in the anterior or posterior portion, and
the scent, medication, or another agent is added within the groove
or impregnated in the pad adjacent to the groove.
[0081] FIG. 27 shows a cross-section of an embodiment of an
elongated absorbent pad 200 that has been modified to carry and
dispense lubricants alone or in admixture with deodorants,
medications (such as a vasoconstrictor or anesthetic to treat
hemorrhoids), and the like. The principles of the elongated
embodiment could, however, be adapted to the non-elongated
embodiments of the type shown in FIG. 24. In the embodiment shown
in FIG. 27, intergluteal absorbent pad 200 includes posterior
portion 202 and anterior portion 204, which is formed with a groove
206 extending longitudinally along the top of anterior pad portion
204. The groove is prefilled with a material 208, for example, with
an ointment, lubricant or other carrier for admixed medications,
deodorants and the like. Placing the intergluteal absorbent pad in
the intergluteal space, with anterior portion 204 adjacent to the
anal orifice, causes the normal transverse constriction of the pad
200 (and particularly compression of anterior portion 204) to
dispense materials which have a suitable viscosity, to the areas
surrounding the anal orifice.
[0082] It has been found that the curvilinear surface portions and
the non-uniform cross sections of the several pads shown herein, is
highly effective in positioning the pad between the buttocks and
retaining it in place. Further, there is no tendency to force the
buttocks apart or to exert undue pressure against their medial wall
portions.
[0083] In one embodiment the pads are molded or otherwise formed
from the cellulose base material, to the desired cross sectional
and longitudinal configurations by apparatus and procedures known
in the art, or formed as described in Gerstenburger.
[0084] In an additional embodiment, the intergluteal absorbent pads
are used to absorb discharge from the anus, and a diagnostic test
is then performed on the absorbed discharge. In one embodiment, the
discharge is fecal material. In another embodiment, the discharge
is a bodily fluid, such as blood or a secretion, such as a
secretion derived from Skene's or Bartholin's glands. In yet
another embodiment, the discharge includes cells, such as cells of
the anal or rectal epithelium, and the cells are analyzed using a
diagnostic test. The diagnostic test can be performed directly on
the discharge absorbed by the intergluteal absorbent pad, or the
discharge or a component of the discharge can be extracted from the
intergluteal pad prior to performing the diagnostic test (see U.S.
Pat. No. 5,094,956).
[0085] The diagnostic test can detect the presence or absence of a
cell type (e.g. see U.S. Pat. No. 5,124,252; U.S. Pat. No.
5,965,375), a protein (e.g. see U.S. Pat. No. 5,190,881; U.S. Pat.
No. 5,661,010), or a nucleic acid (e.g. see U.S. Pat. No.
5,538,851; U.S. Pat. No. 5,459,034) in the anal discharge. The
diagnostic test can also be used to detect occult blood (see U.S.
Pat. No. 4,920,045; U.S. Pat. No. 5,563,071), or the presence of a
virus, such as human papillomavirus (HPV), or a microorganism, such
as an enteric pathogen (see U.S. Pat. No. 5,705,332; U.S. Pat. No.
5,627,275). The diagnostic test can be a qualitative,
semi-quantitative, or quantitative test. In one specific,
non-limiting example, the diagnostic test is used to detect a
biological parameter associated with colorectal cancer or anal
cancer.
[0086] In a specific, non-limiting example, anal discharge is
collected on an absorbent anal pad and a diagnostic test is then
performed on the anal discharge to detect human papillomavirus
(HPV) infection. For example, the diagnostic test can detect the
presence of HPV nucleic acid (see U.S. Pat. No. 5,580,907; U.S.
Pat. No. 5,876,922; U.S. Pat. No. 5,783,412; U.S. Pat. No.
5,447,839; U.S. Pat. No. 5,283,171). Alternatively, the diagnostic
test can detect the presence of a protein associated with HPV
infection (see U.S. Pat. No. 5,045,447).
[0087] In one embodiment, a kit is provided for collecting a sample
of anal discharge. The kit includes an absorbent pad, and a
packaging means, such as a plastic vial or a plastic bag, for
packaging the absorbent pad. The kit can also include directions
for the use of the pad, and instructions for the use of the package
for mailing the pad to a remote laboratory, where a diagnostic test
(e.g. a test to detect the presence of HPV), is performed.
[0088] FIG. 29 shows a particular embodiment wherein the absorbent
pad is formed of a polypropylene or polyester non-woven fabric with
a rayon sliver core. The absorbent pad has an overall length L of
about 15 to about 75 mm, and an overall height H of about 19 to
about 22 mm. Of the overall height of the absorbent pad, the
anterior portion AP of the absorbent pad has a height APH of about
4 to about 7 mm. The posterior portion PP of the absorbent pad has
a height PPH of about 12 to about 18 mm. In addition, posterior
portion PP of the pad has a width PPW of about 8 to about 10 mm.
Anterior portion AP has a width APW less than width PPW of
posterior portion PP of the pad. In one specific, non-limiting
example, width PPW of posterior portion PP of the absorbent pad is
from about 4 to about 7 mm. Posterior portion PP of the pad is
demarcated from anterior portion AP of the pad by stitching S. In
one specific, non-limiting example the stitching is standard 401
chain stitch of about 8-10 SPI.
[0089] FIGS. 30-31 show another embodiment of a rectangular pad 300
which includes an absorbent front 302 (FIG. 31) and a substantially
liquid impermeable (such as a polypropylene) backing 304. Pad 300
is folded (as shown in FIG. 30) to present a tapered profile with a
leading edge 306. In use, leading edge 306 of folded pad 300 is
inserted in the intergluteal space, with edge 306 against the anus.
The large surface area of the faces of pad 300 frictionally engage
the surrounding tissue to hold the pad in place during ambulation
and other activities. In a particularly disclosed embodiment, pad
300 has a length of at least 15 mm, for example 15-75 mm, and a
width of at least 35 mm, for example 38-45 mm. An indentation or
other indicia can be provided on the pad to indicate where it
should be folded prior to insertion in the intergluteal space, or
alternatively the pad can be provided in a pre-folded
condition.
[0090] In view of the many possible embodiments to which the
principles of the invention may be applied, it should be recognized
that the illustrated embodiments are only particular examples of
the invention and should not be taken as a limitation on the scope
of the invention. Rather, the scope of the invention is defined by
the following claims. We therefore claim as our invention all that
comes within the scope and spirit of these claims.
* * * * *