U.S. patent application number 10/808191 was filed with the patent office on 2004-09-16 for self-sampling brush and method for use.
Invention is credited to Wallach, Ronald M..
Application Number | 20040181170 10/808191 |
Document ID | / |
Family ID | 24760823 |
Filed Date | 2004-09-16 |
United States Patent
Application |
20040181170 |
Kind Code |
A1 |
Wallach, Ronald M. |
September 16, 2004 |
Self-sampling brush and method for use
Abstract
A device is provided for self-sampling a body cavity, in
particular the cervix, and a method is provided to use the device
to obtain samples from the cervix for testing for the presence of
human papillomavirus (HPV) DNA. The device includes elongated
flexible bristles attached to a handle to form a mop-like sampling
member. The sampling member is rotated to mop the cervix and obtain
a sample of cervical cells on the elongated bristles. The sampling
device is then withdrawn from the vaginal cavity and the sample is
sent for analysis.
Inventors: |
Wallach, Ronald M.;
(Westport, CT) |
Correspondence
Address: |
EDWARDS & ANGELL, LLP
P.O. BOX 55874
BOSTON
MA
02205
US
|
Family ID: |
24760823 |
Appl. No.: |
10/808191 |
Filed: |
March 24, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10808191 |
Mar 24, 2004 |
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10099792 |
Mar 14, 2002 |
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6740049 |
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10099792 |
Mar 14, 2002 |
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09687542 |
Oct 13, 2000 |
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6387058 |
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Current U.S.
Class: |
600/569 ;
600/572; 604/1 |
Current CPC
Class: |
A61B 10/0291 20130101;
A61B 2010/0216 20130101; A61B 2010/0074 20130101 |
Class at
Publication: |
600/569 ;
600/572; 604/001 |
International
Class: |
A61B 010/00 |
Claims
I claim:
1. A device for obtaining a sample from a body cavity, comprising:
(a) a plurality of elongated flexible bristles of approximately
uniform length connected to a handle to form a mop-like sample
collecting member, said bristles being disposed in a direction
substantially parallel to the axis of the handle.
Description
[0001] This application is a continuation of prior application Ser.
No. 09/687,542 filed on Oct. 13, 2000.
FIELD OF THE INVENTION
[0002] The present invention relates to a self-sampling device
which permits the obtainment of samples from body cavities and a
method for using the device. In particular, the present invention
permits women to self-sample to obtain cervical cells for testing
for Human Papillomavirus DNA.
BACKGROUND OF THE INVENTION
[0003] Cytologic screening programs have been associated with
dramatic reductions in the incidence of cervical cancer in certain
parts of the world. Cytologic screening typically involves
obtaining a sample of cells or tissue from the cervix and testing
the sample for the presence of cervical carcinoma cells. The most
common method used for this testing is the Papanicolaou (Pap)
smear. Pap smears are generally performed by a physician during
gynecological examination of the patient using sampling apparatus
designed for use only by a physician. Due to the inconvenience,
time and discomfort involved in having the Pap smear test performed
by a physician, many women do not have the test performed at the
recommended intervals. Also, in many countries, women do not have
sufficient access to health care providers or health care
facilities to have regular Pap smear testing performed. As a
result, in these countries, cytologic screening to reduce the
incidence of cervical cancer has not been successfully
implemented.
[0004] Recent studies have shown that testing of samples of
cervical cells for human papillomavirus (HPV) DNA can be used to
screen for cervical disease. It has been reported that HPV DNA
testing of clinician-obtained cervical samples has a sensitivity
for detection of high-grade cervical squamous intraepithelial
lesions and invasive cervical cancer that is equivalent or superior
to that of a Pap smear. (Wright et al. 2000, HPV DNA testing of
self-collected vaginal samples compared with cytologic screening to
detect cervical cancer, Jour. Am. Med. Assoc. Vol. 283, No. 1).
Clinician-obtained samples for HPV DNA testing have many of the
same drawbacks as Pap smears, however, because the samples must be
obtained by health care professionals and therefore are
inconvenient, time consuming, uncomfortable, and may not be
available to women in certain parts of the world.
[0005] Wright et al. have reported the results of studies showing
that self-collected cervical cell samples can be used effectively
for HPV DNA testing as a means of screening for women at high risk
of having cervical disease. This screening can be used to identify
women who should have more extensive testing performed.
Accordingly, HPV DNA testing of self-collected samples can be used
to identify women at high risk of having cervical disease in parts
of the world where access to physicians or health care facilities
is limited. Therefore, there is a need for a relatively easy and
inexpensive means for self-collecting of samples to test for HPV
DNA.
[0006] Prior devices used for collecting samples of cervical cells
have several drawbacks and disadvantages. For example, many devices
require a physician to collect the sample. Kist, U.S. Pat. No.
4,700,713, describes a sampling device comprised of bristles shaped
to fit the cervix mounted on a handle, with each bristle having at
least one longitudinal sharp edge. This device is intended for
sampling only by a physician. Proper placement of the shaped
bristles of the device with respect to the cervix must be effected
by a physician during a gynecological examination and there is no
means provided to guide the sampling device and assure proper
placement to permit self-sampling.
[0007] White, U.S. Pat. No. 4,175,008, describes a culture specimen
collection and transport device. The culture specimen collection
portion of the device consists of a swab with an absorbent material
at the end of the swab. There is no structure associated with the
swab that would permit self-sampling of cervical tissue. Indeed,
White states that his device is intended for use by physicians to
obtain culture specimens, particularly of the ears, nose and
throat. Accordingly, such a device could not be used for
self-sampling.
[0008] Although several devices for self-sampling of the cervix
have been developed, each of the devices has drawbacks and
disadvantages. Canna, U.S. Pat. No. 5,121,752, describes a device
for self-sampling to obtain PAP smear samples. A sample is obtained
using a scraper head on a handle to scrape a sample from the
cervix. A shaped speculum is used to insert the sampling device. In
use, a hand mirror is required to locate the device properly to
obtain a sample. This makes the device relatively difficult to use
to obtain a sample. Also, the scraping action of the sampling
portion of the device can cause discomfort, discouraging use of the
device.
[0009] Other devices for self-sampling use absorbent swabs or other
methods to collect the samples. For example Sak, U.S. Pat. No.
5,787,891, and Worthen, U.S. Pat. No. 5,445,164, describe
self-sampling devices that use absorbent materials at the end of
plunger type devices to absorb samples from-the area of the cervix.
These devices are relatively complicated in their design, rendering
them more difficult to use and more expensive to manufacture. Also,
relatively precise placement of the device is necessary to ensure a
representative sample is obtained. The need for precise placement
of self-sampling devices is a disadvantage, as it is difficult for
a woman to ensure precise placement during self-sampling. In
addition, absorbent material will take longer to release its
captured specimen, and may not release all that it has absorbed.
This can reduce the dependability of the test if the cells that are
the subject of the test are more readily absorbed by the absorbent
material.
[0010] Accordingly, the present invention overcomes one or more of
the drawbacks or disadvantages of the prior art and provides an
easy to use and inexpensive device to permit self-sampling of a
body cavity, and in particular to permit self-sampling of the
cervix to obtain a sample for testing for HPV DNA.
SUMMARY OF THE INVENTION
[0011] The present invention provides a device for self-sampling to
obtain a sample of cells from the cervix to be tested for HPV DNA.
In one embodiment, the device is comprised of a mop-like brush made
of a plurality of elongated flexible bristles which are attached to
a handle. The brush-and handle are placed within an annular
insertion shield. The distal end of the insertion shield is
designed to assist in insertion of the sampling device into the
vaginal cavity and in positioning the sampling device in the area
of the cervix to obtain a sample of cervical cells.
[0012] After the sampling device is fully inserted within the
vaginal cavity and the distal end of the insertion shield is
located proximate to the cervix, the insertion shield is at least
partially withdrawn, exposing the mop-like brush of the device to
the cervix. The exposed mop-like brush is then rotated by the
handle to obtain a sample of cells from the epithelium layer of the
cervix adhering to the mop-like bristles of the brush. Due to the
design of the mop-like brush, a representative sample of cells can
be obtained without the need to locate the sampling device in an
exact location relative to the cervix. After the sample has been
collected, the handle is used to pull the mop-like portion back
into the insertion shield and the sampling device is removed from
the vagina. The mop-like brush containing the cell sample can then
be tested to determine the presence of HPV DNA.
[0013] Among the advantages of the device is that a sample of
cervical cells can be easily obtained by women without the
intervention of a physician or health care professional.
Accordingly, the time and expense involved in obtaining a sample is
reduced. A further advantage of the invention is that the mop-like
brush allows a representative sample of the cervix area to be
obtained on the bristles of the mop-like brush without the need to
locate the device precisely in relation to the cervix. Also, tests
performed on samples obtained using non-absorbent material are more
consistent than samples obtained on absorbent material.
Accordingly, the sampling device is easy to use to obtain
relatively accurate test results for HPV DNA.
DRAWING DESCRIPTION
[0014] So that those having ordinary skill in the art to which the
subject invention appertains will more readily understand how to
perform the method of the subject invention, reference may be had
to the drawings wherein:
[0015] FIG. 1 is a schematic view of the mop-like brush and handle
of the sampling device.
[0016] FIG. 2 is a schematic view of an insertion shield having a
flared, open distal end, with the handle passing through the open
distal end of the insertion shield and the mop-like brush extended
beyond the open distal end of the insertion shield.
[0017] FIG. 3 is a schematic view of an insertion shield having a
closed distal end.
[0018] FIG. 4 is a schematic view of the closed ended insertion
shield in use with the mop-like brush extended through the distal
end of the insertion shield and in position for sampling.
[0019] FIG. 5 is a schematic view of a closed ended insertion
shield containing an inner shield and a sample collecting
member.
[0020] FIG. 6 is a cross-sectional view through line 6-6 FIG. 4 of
the proximal end of the insertion shield exhibiting a keyed opening
therein which interlocks with similar protrusions on the handle of
the sampling member to facilitate rotation thereof.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0021] The present invention is directed to a novel device for
self-sampling to obtain a sample of cervical cells for HPV DNA
testing. Preferred embodiments of the invention are described below
in conjunction with the drawings provided herein. The preferred
embodiments disclosed herein are to be considered exemplary of the
principles of the present invention and are not intended to limit
the invention to the embodiments described or illustrated. Various
modifications will be apparent to those skilled in the art without
departing from the scope or spirit of the invention disclosed
herein.
[0022] Referring now to the figures wherein like reference numerals
identify similar structural elements of the subject invention, as
illustrated in FIG. 1, in one embodiment of the invention, the
device comprises a mop-like brush (10) with a plurality of bristles
(11) extending from a base member (12). The bristles are preferably
cylindrical in shape, and are of approximately uniform length. The
bristles (11) and the base member (12) may be molded as one piece.
Alternatively, the base member (12) may be molded with holes in the
surface (16) of the base member to receive the bristles and the
bristles are then inserted into the holes in the base member. The
holes are preferably of a diameter approximately equal to the
diameter of the bristles such that the bristles are retained in the
base member by friction, or the bristles may be glued into the
holes. The bristles of the mop-like brush are oriented
substantially parallel to each other.
[0023] The base member (12) is attached to a handle (14) to form a
sample collecting member (15). The handle (14) is press fit into a
cavity in the end of the base member (12) opposite the bristles.
The cavity in the end of the base member can be a keyed opening
with the handle (14) shaped to fit closely within the keyed
opening. The press fit between the handle and the base member
should be such that the base member and bristles can be removed
from the handle for sample analysis. Preferably the base member
should be removable from the handle by applying a force to the base
member of about three to six pounds.
[0024] The bristles of the mop-like brush can be made of any
appropriate material known to one skilled in the art. The bristles
are preferably made of a flexible plastic material such as, for
example, polyethylene, polyurethane, polyvinyl chloride,
polysiloxanes or nylon. The bristles are preferably at least one
inch long and have a small diameter to be as flexible as possible.
The tips of the bristles should be blunted to prevent puncture
wounds. A long, slender design for the bristles increases the
softness and surface area used for the mop-like sampling mechanism.
To aid in molding, the bristles can be tapered with a smaller
diameter at the tip of the bristle and a larger diameter at the
base of the bristle.
[0025] An appropriate length for the bristles used in the mop-like
brush may be determined using Euler's Formula, 1 l = IE 4 P
[0026] where P is the total ultimate load in pounds, I is the least
moment of inertia in inches.sup.4, E is the modulus of elasticity
of the material in pounds/inch.sup.2, and l is the length in
inches. Euler's formula is used for columnular structures which are
so slender that bending or buckling action predominates and
compressive stresses are not taken into account. Euler's formula
can be used to determine a length for the bristles where they will
bend or buckle, and thereby provide a mop-like brush. While the use
of Euler's formula can aid in determining an appropriate length for
the bristles, the invention is not limited to bristles whose
lengths are determined by Euler's Formula or to any specific length
for the bristles. The bristles may be any length provided that they
are sufficiently long and flexible so as to form a mop-like
brush.
[0027] The base member and handle may be made of any appropriate
material known to one skilled in the art. The base member and
handle are preferably made of a molded plastic such as, for
example, polystyrene, polypropylene or nylon. Using a molded
plastic allows the parts of the sample collecting member to be
manufactured relatively inexpensively.
[0028] Referring to FIG. 2, the mop-like brush (10) and handle (14)
are slidably disposed within a flared open ended annular insertion
shield (20), such that the mop-like brush (10) is contained within
the insertion shield (20) during insertion and removal from the
vaginal cavity, and can be extended beyond the open distal end (21)
of the insertion shield (20) for sampling. The insertion shield
(20) is sized to allow relatively easy insertion into the vaginal
cavity. The open distal end (21) of the insertion shield (20) is
flared to allow easy insertion of the sampling device into the
vaginal cavity and to assist the user in locating the sampling
device in the area of the cervix. The handle (14) extends through
the annular insertion shield (20) such that the handle (14) can be
held and manipulated as necessary while samples are obtained. The
insertion shield can be made of any appropriate material known to
one skilled in the art. The insertion shield is preferably made of
a molded plastic such as, for example, polystyrene, polypropylene
or nylon.
[0029] In use, the insertion shield (20) containing the mop-like
brush (10) is inserted into the vaginal cavity and the open distal
end (21) of the insertion shield (20) is located in the area of the
cervix. After the open distal end (21) has been placed in the
proper location for sampling, the insertion shield (20) is
partially withdrawn by sliding it along the handle (14). While the
insertion shield is being partially withdrawn, the mop-like brush
(10) is held stationary, causing the mop-like brush to extend
beyond the flared open distal end (21) of the insertion shield (20)
and exposing the mop-like brush (10) to the cervix. With the
mop-like brush (10) in contact with the cervix, the sampling device
is rotated using the handle (14), and a sample of cervical cells is
obtained on the bristles (11) by the mopping action of the mop-like
brush (10). The sampling device is preferably rotated at least two
full revolutions in order to obtain a representative sample. The
mopping action allows an adequate sample of cervical cells to be
obtained without the need to precisely locate the mop-like brush in
relation to the cervix.
[0030] After sampling is complete, the handle (14) is pulled
backward to retract the mop-like brush (10) into the insertion
shield (20). The insertion shield is removed from the vaginal
cavity. The sampling device is then packaged for shipment to a
laboratory for analysis for HPV DNA. In the preferred embodiment,
the base member is removed from the handle and placed in a
container with an appropriate solution. To avoid contamination of
the sample, removal of the base member from the handle can be
achieved using tweezers or an equivalent device. Alternatively, the
insertion shield may include a stop in the interior of the annulus
such that the base member can be pulled against the stop with
sufficient force to remove the base member from the handle. The
base member may then be dropped out of the insertion shield into
the container. The container may contain a solution for preserving
and fixation of the cells obtained on the bristles. An example of
such a solution is described in Hurley, U.S. Pat. No. 5,256,271.
Other appropriate solutions known to those skilled in the art may
be used. After it has been removed from the handle and placed in an
appropriate container, the base member can be shipped to a
laboratory for analysis. If a solution is used in the container
that permits results to be interpreted by the patient, the
container may be retained by the patient for a predetermined period
of time and the result interpreted by the patient.
[0031] In another embodiment of the sampling device, illustrated in
FIG. 3, an annular insertion shield (30) is used to contain the
mop-like brush on the sample collection member for insertion into
the vaginal cavity. The arcuate distal end (31) of the insertion
shield (30) is shaped to permit easy insertion into the vaginal
cavity and to assist in locating the insertion shield proximate to
the cervix. In this embodiment of the invention, the arcuate distal
end (31) of the insertion shield (30) is normally closed. A
plurality of slots (32) are cut into the arcuate distal end of the
insertion shield such that the arcuate distal end (31) can be
separated and opened upon application of force to the inside
surface of the insertion shield (30). The slots can penetrate the
material of the distal end of the insertion shield either fully or
partially so long as the distal end can be opened upon application
of force from the sample collection member. The number and shape of
the slots can be varied as desired. The handle (14) and the
mop-like brush are slidably disposed within the insertion shield
(30).
[0032] In use, the insertion shield (30) containing the mop-like
brush is inserted into the vaginal cavity and the arcuate distal
end (31) of the insertion shield (30) is located proximate to the
cervix. After the distal end (31) has been placed in the proper
location for sampling, the insertion shield (30) is partially
withdrawn by sliding it along the handle (14). While the insertion
shield is being partially withdrawn, the handle (14) is held
stationary, causing the mop-like brush to exert pressure on the
inner arcuate surface of the distal end (31) of the insertion
shield (30). As illustrated in FIG. 4, the slots on the distal end
(31) of the insertion shield allow the distal end to open, exposing
the mop-like brush (10) to the cervix. With the mop-like brush (10)
in contact with the cervix, the sampling device is rotated using
the handle (14), and a sample of cervical cells is obtained on the
bristles (11) by the mopping action of the mop-like brush. The
mopping action provides an adequate sample for testing without the
need to precisely locate the mop-like brush in relation to the
cervix.
[0033] After sampling is complete, the handle (14) is pulled
backward to retract the mop-like brush (10) into the insertion
shield (30). The insertion shield is removed from the vaginal
cavity, and the sample is packaged for shipment to a laboratory for
analysis or self-analyzed as discussed herein above.
[0034] In a further embodiment of the invention illustrated in FIG.
5, the annular insertion shield (30) is used to contain an inner
shield (36) and the sample collection member. The arcuate distal
end (31) of the insertion shield (30) is shaped to permit easy
insertion into the vaginal cavity, and includes a plurality of
slots (32) such that the arcuate distal end (31) can be separated
and opened upon application of force to the inside surface of the
insertion shield (30).
[0035] In using this embodiment of the invention, the insertion
shield (30) containing the inner shield and the sampling member is
inserted into the vaginal cavity, the insertion shield is pulled
back over the handle, removed and discarded. The open distal end of
the inner shield (36) is placed proximate to the cervix, and the
inner shield is partially withdrawn by sliding it alone the handle
(14). This exposes the mop-like brush to the cervix. The sampling
device is then rotated at least two full revolutions, and a sample
of cervical cells is obtained.
[0036] After sampling is complete, the handle is pulled backward to
retract the mop-like brush into the inner shield. The inner shield
containing the sampling member are removed from the vaginal cavity,
and the sample is packaged for shipment to a laboratory or
self-analyzed as discussed herein above.
[0037] In a further embodiment of the invention, the insertion
shield and sampling member handle may be adapted to allow rotation
of the mop-like end of the sampling member by holding and rotating
the insertion shield. In this further embodiment of the invention,
the proximal end of the insertion shield is partially closed, for
example by a plug or a cap. As illustrated in FIG. 6, the partially
closed proximal end of the insertion shield (50) includes a keyed
opening (51) to permit the handle of the sampling member (52) to
pass through the partially closed proximal end of the insertion
shield (50). The keyed opening can be any shape that allows the
insertion shield to engage and rotate the sampling member when the
insertion shield is rotated. The handle of the sampling member (52)
is shaped to fit closely within the keyed opening (51). After the
insertion shield is located in position for sampling as described
herein above, rotation of the mop-like brush is accomplished by
holding and rotating the insertion shield. As the insertion shield
is rotated, the handle of the sampling member (52) is engaged by
the keyed proximal end of the insertion shield (50), causing the
sampling member to rotate with the insertion shield.
[0038] The present invention and method for using the invention to
obtain cervical cell samples overcomes the problem of requiring a
physician to obtain samples for testing for HPV DNA. The mop-like
brush used for sampling is capable of obtaining an adequate sample
for testing without the need to precisely locate the mop-like brush
in relation to the cervix. The mopping action results in sample
from a relatively large area, making the device ideal for
self-testing where precise location of the sampling device may not
occur. Accordingly, the invention offers the advantages of being
self-administered relatively easily, and it can be used for
cytologic screening in areas where there is poor availability of
physicians or other health care professionals.
[0039] The present invention is not limited to HPV DNA testing, and
it may be used for obtaining samples from the cervix or vaginal
cavity for other types of testing. Other uses for the sampling
device of the present invention will be readily apparent to those
of ordinary skill in the art. For example, the sampling device may
be used for retrieval of samples in rape investigations, or in
applications for obtaining samples from other body cavities.
[0040] As will be recognized by those of ordinary skill in the art
based on the teachings herein, numerous changes and modifications
may be made to the above-described invention without departing from
its spirit or scope as defined in the appended claims. Accordingly,
this detailed description of preferred embodiments is to be taken
in an illustrative, as opposed to a limiting sense.
* * * * *