Surgery – Means and methods for collecting body fluids or waste material – Absorbent pad for external or internal application and...
Reexamination Certificate
1999-03-01
2003-09-30
Lo, Weilun (Department: 3761)
Surgery
Means and methods for collecting body fluids or waste material
Absorbent pad for external or internal application and...
C604S385140, C604S385190
Reexamination Certificate
active
06627790
ABSTRACT:
BACKGROUND OF INVENTION
1. Field of the Invention
The present invention relates to collection devices for recovering samples of bodily fluids or cells for subsequent laboratory analysis and, more particularly, to a collection device and method for allowing the patient to recover samples of bodily fluids, secretions, cells, and infectious and non-infectious agents, in whole all hereinafter referred to as bodily substances, and, for instance, to a modified sanitary napkin for collecting such substances from the genital, anal or urinary regions, and to a method associated with the use thereof.
2. Description of Prior Art
U.S. Pat. No. 5,231,992 issued on Aug. 3, 1993 to Leon discloses a low-impact cervical cell and fluid collector which includes a substantially disc-shaped main body
12
which defines a generally concave recess
14
into which a porous collection membrane
16
is mounted. Therefore, when the collector
10
is in place adjacent to the patient's cervix, cells and fluids adhere to the outer surface of the membrane
16
. Underneath the membrane
16
, there is provided a layer
24
of a cell-moistening material or agent, such as a polymer gel adapted to release water during cell collection for moistening collected cells through the pores of the membrane
16
when the cells are adhered to the outer surface thereof. The main body
12
can be provided with a string
18
to facilitate the removal of the collector
10
from the body.
French Patent Application which was published as FR-2 599 500 on Dec. 4, 1987 in the name of Chieusse discloses a transparent adhesive strip for taking a sample directly from the skin's surface for microscopic examination or analysis, the adhesive strip comprising a rigid transparent resin or glass plate
1
covered successively with a transparent layer
2
which is self-adhesive on both of its sides, an isolating film or coating
4
of shorter length, and a semi-rigid cover layer
3
made, for instance, of strong paper or cardboard. The limited length of the film
4
defines a section
5
where the cover layer
3
adheres directly to the adhesive
2
and forms a joint line
6
which allows for the cover layer
3
to be pivotally lifted about the hinge
6
, wherein in a closed position
7
, the sample-taking surface
9
is protected for its transport or storage, whereas in its open position
8
, the adhesive surface
2
can be brought into direct contact with the skin's surface such as to enable the adhesive strip
2
to remove and collect desired samples from the skin and other surfaces for subsequent analysis thereof.
U.S. Pat. No. Re. 24,666 issued on Jul. 7, 1959 to Draghi discloses a tampon for the detection of cancer of the pelvic region. More particularly, the tampon of this U.S. Patent constitutes a preliminary diagnosis method which determines if there are present any indicia of cancer by taking a sample of cells which are present in the cervical canal and in the vagina and by the subsequent microscopic analysis of these cells. The tampon includes a tampon body
10
partly covered by a jacket
12
terminating with an enlarged cap
13
and, at the other end of the tampon body
10
, there is provided a string
22
. The assembly of the body
10
and jacket
12
forms a detection tampon
14
. The enlarged cap
13
which closes one end of the tampon
14
is adapted to extend farthest into the vaginal canal and to collect and retain in moist form cells thereof. The jacket
12
also collects cells and retains them in a relatively moist condition thereby ensuring a more accurate clinical evaluation.
U.S. Pat. No. 3,850,160 issued on Nov. 26, 1974 to Denson discloses a diagnostic tampon
10
having a supporting body
13
covered by an outer film
12
and provided at one end thereof with a removal string
11
. The tampon is particularly adapted for collecting cellular material from body cavities, in particular from the vaginal cavity, for subsequent examination.
U.S. Pat. No. 5,432,097 issued on Jul. 11, 1995 to Yourno teaches a method for the recovery of blood cells from dried blood spots on a filter paper.
U.S. Pat. No. 5,119,828 issued on Jun. 9, 1992 to Miller discloses a device
10
for collecting sebum which is secreted by the sebaceous glands of a patient, the device
10
including a microporous film
12
which is opaque to light when the pores are filled with gaseous material and which is substantially translucent when the film pores are filled with sebum. The film
12
is mounted to a substrate
14
which defines a light absorbing area
16
for enhancing visualization of the pores of the film
12
when filled with sebum. In use, the device is pressed against the patient's skin surface such that the film
12
contacts the skin and absorbs its sebum, whereby a sebum spot pattern is developed in the film
12
and is visually enhanced by way of the light absorbing area
16
.
U.S. Pat. No. 5,088,502 issued on Feb. 18, 1992 to Miller discloses a device
10
for sampling the surface of the skin which includes a substrate
12
having a light absorbing area
14
disposed thereon with an adhesive layer
16
being disposed on the substrate
12
such as to overlie the light absorbing area
14
. The adhesive layer
16
is optically clear and under pressure conforms to the surface of the skin to be sampled. A removable protective film
18
provided with a tab
20
is disposed on the adhesive layer
16
for protecting the same prior to use of the device. The device and, more particularly, the adhesive layer
16
is placed against the skin surface such that, when removed, skin cells adhere to the adhesive layer
16
. The sampled cells can then be visualized in view of the light absorbing area
14
.
U.S. Pat. No. 4,789,629 issued on Dec. 6, 1988 to Baker et al teaches a device for collecting and testing fecal occult blood which includes a pocket-like member
16
and an absorbent insert
24
disposed in the pocket member
16
. The pocket member
16
is disposed on the inside front cover of the device such that when the cover is in a closed position thereof, the pocket
16
overlies the fecal smear on the specimen receiving sheet
36
, whereby with one single collection, two separate membranes, that is the specimen receiving sheet
36
and the absorbent insert
24
, receive the components of the fecal sample and can be individually and independently tested.
U.S. Pat. No. 4,808,379 issued on Feb. 28, 1989 to Wardlaw et al discloses a device for obtaining stool samples and detecting occult blood and which is used in a way similar to toilet tissue to obtain a stool sample on a receptor sheet
26
provided in the device. Therefore, to obtain the stool sample, the patient, after defecation, draws the cover sheet
32
and its holes
34
across the rectum in the same manner as toilet tissue such that stool is thus wiped onto the cover sheet and passes through the openings
34
and deposits in spots on the receptor sheet
26
. The cover sheet
32
is then peeled off and discarded, thereby exposing the stool spots S of the receptor sheet
26
, after which the stool spots S can be effectively sealed in the device by folding the impermeable sheet
2
.
SUMMARY OF INVENTION
It is therefore an aim of the present invention to provide an improved device for allowing a patient to collect externally from the body samples of bodily substances, such as fluids, cells, tissues, microorganisms, etc.
It is also an aim of the present invention to provide an improved method for allowing a patient to collect externally from the body samples of bodily substances, such as fluids, cells, tissues, microorganisms, etc.
It is a further aim of the present invention to provide a modified sanitary napkin for collecting samples of bodily substances from the genital, anal or urinary regions and, for instance, vaginal secretions.
It is a still further aim of the present invention to provide a modified sanitary napkin provided with an absorbent layer for collecting the samples of bodily substances from the genital, anal or urinary regions.
It is a still further aim of the
Bouchard Celine
Fortier Michel
Morin Carol
Calfee Halter & Griswold LLP
Exy-Detek (EDI) Inc.
Lo Weilun
Webb Jamisue A
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