U.S. patent application number 10/073609 was filed with the patent office on 2002-07-04 for personal cervical cell collector.
This patent application is currently assigned to MOLECULAR DIAGNOSTICS, INC.. Invention is credited to Anderson, David M., Domanik, Richard A., Gombrich, Peter P..
Application Number | 20020087096 10/073609 |
Document ID | / |
Family ID | 26838918 |
Filed Date | 2002-07-04 |
United States Patent
Application |
20020087096 |
Kind Code |
A1 |
Anderson, David M. ; et
al. |
July 4, 2002 |
Personal cervical cell collector
Abstract
A cervical cell collection device can easily and comfortably be
used by a woman in the privacy and comfort of her own home. Once
the woman obtains the cervical cell sample, she can be forward it
to a physician's office or other lab location for analysis. The
collection device includes an outer guide assembly and an inner
sampling assembly bearing a collector.
Inventors: |
Anderson, David M.;
(Hinsdale, IL) ; Gombrich, Peter P.; (Chicago,
IL) ; Domanik, Richard A.; (Libertyville,
IL) |
Correspondence
Address: |
MERCHANT & GOULD PC
P.O. BOX 2903
MINNEAPOLIS
MN
55402-0903
US
|
Assignee: |
MOLECULAR DIAGNOSTICS, INC.
414 N. Orleans, Suite 305
Chicago
IL
60610
|
Family ID: |
26838918 |
Appl. No.: |
10/073609 |
Filed: |
February 11, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10073609 |
Feb 11, 2002 |
|
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|
09603625 |
Jun 26, 2000 |
|
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|
60141242 |
Jun 25, 1999 |
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60210218 |
Jun 8, 2000 |
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Current U.S.
Class: |
600/572 ;
600/569; 604/1 |
Current CPC
Class: |
A61B 10/0291 20130101;
A61B 2010/0074 20130101; A61B 10/0096 20130101; A61B 10/0045
20130101 |
Class at
Publication: |
600/572 ;
600/569; 604/1 |
International
Class: |
A61B 010/00 |
Claims
We claim:
1. A cervical cell collection apparatus intended for personal use,
the collection apparatus comprising: an outer guide assembly curved
to approximate the natural curvature of a woman's vagina, the outer
guide assembly comprising a protective tip comprising an absorbent
material; an inner sampling assembly positioned within the outer
guide assembly, the inner sampling assembly comprising a collector
pad, the inner sampling assembly moveable from a first position in
which the collector pad is located within the outer guide assembly
to a second position in which the collector pad is located outside
the outer guide assembly; wherein the inner sampling assembly is
configured to collect cervical cells while in the second position
while the collector pad is protected against unwanted sample
contamination while in the first position.
2. The collection apparatus of claim 1, wherein the absorbent
material comprises flocking and is suitable for removing mucus from
the cervix.
3. The collection apparatus of claim 1, wherein the inner sampling
assembly comprises a grippable pusher bearing the collector pad at
one end thereof.
4. The collection apparatus of claim 1, wherein the collector pad
comprises a material selected from the group consisting of cloth,
sponge, foam and other open-celled porous materials.
5. The collection apparatus of claim 1, wherein the collector pad
comprises a large foam disk suitably sized to sample an
ecto-cervical region and a small foam disk suitably sized to sample
an endo-cervical region.
6. The collection apparatus of claim 1, wherein the protective tip
is configured to reversibly open to allow passage of the inner
sampling assembly and is configured to close once the inner
sampling assembly is withdrawn.
7. A personal cervical cell collection kit, the kit comprising: a
personal collector comprising the cervical cell collection
apparatus of claim 1, and; a fixative canister comprising: an outer
shell; an inner cap that fits within the outer shell but is
configured to receive the collector pad of the personal collector;
a unit dose container comprising an easily pierceable segment, the
dose container containing a volume of fixative; and an outer cap
configured to cover an end of the outer shell.
8. The collection kit of claim 7, wherein the collector pad can
puncture the easily pierceable segment of the unit dose container,
thereby permitting the fixative to flow over the collector pad
contained within the protective tip.
9. A method of obtaining a cervical cell sample without requiring
the assistance of medical personnel, the method comprising steps
of: obtaining a kit comprising a personal collector and a fixative
container, the personal collector comprising a sampling collector
pad; inserting the personal collector into the vagina until the
personal collector contacts the cervix; removing mucus from the
cervix; partially withdrawing the personal collector; extending the
sampling collector pad to contact the cervix; collecting a cervical
cell sample; withdrawing the sampling collector pad back into the
personal collector; withdrawing the personal collector from the
vagina; and inserting the sampling collector pad into the fixative
container to preserve the cervical cell sample.
10. The method of claim 9, wherein at least one of the step of
removing mucus from the cervix and the step of collecting a
cervical cell sample comprises rotating the personal collector to
remove the mucus.
Description
RELATED APPLICATIONS
[0001] This application is a continuation under 37 CFR .sctn.
1.53(b) of U.S. Ser. No. 09/603,625, filed Jun. 26, 2000, which
application is specifically incorporated by reference herein. The
parent application claims priority to provisional application
Serial No. 60/141,242, filed Jun. 24, 1999 entitled "PERSONAL
CERVICAL SAMPLE COLLECTION SYSTEM" and provisional application
bearing Attorney Docket No. P98,3254, filed Jun. 8, 2000, entitled
"PERSONAL CERVICAL CELL SPECIMEN COLLECTOR".
TECHNICAL FIELD
[0002] The invention relates generally to cervical cell sampling
and more specifically to devices and methods whereby cervical cell
samples can be personally collected by a patient. The invention
relates to devices and methods in which the cervical cell samples
are collected by the patient and then forwarded to a physician or
lab for analysis.
BACKGROUND
[0003] Cervical cancer is a leading form of cancer among women. In
the United States alone, there are believed to be more than two
million cases of precancerous cervical abnormalities annually. The
U.S. also sees, on average, about sixty five thousand cases of
cervical carcinoma and about sixteen thousand cases of invasive
cervical cancer. Although screening is less common outside the
Unites States, nearly half a million cases of cervical cancer are
detected each year around the world.
[0004] Cervical cancer frequently begins as a precancerous lesion
of the cervix. These lesions are also known as cervical
intraepithelial neoplasia. If left untreated, these lesions can
deepen over time and ultimately develop into an invasive cancer of
the cervix and associated tissues. Fortunately, early detection
followed by appropriate treatment results in a very high cure rate
for cervical cancer.
[0005] Therefore, it is quite important that at least certain
factions of the female population undergo regular screening. These
factions include patients with previous cervical abnormalities and
those who have a family history of cervical abnormalities. Women
who are sexually active are at greater risk and should undergo
regular screening, as are those who test positive for HPV (human
papillomavirus). This is a sexually transmitted virus that in some
forms can cause genital warts.
[0006] During the 1940's, Dr. George Papanicolaou developed a
screening test which bears his name and which has become the most
widely used screening technique for detecting abnormal cervical
cells. Today, this test is known more commonly as the PAP test or
the PAP smear test. Typically, the PAP test is performed in the
physician's office as part of a woman's routine gynecological
examination. The test involves collecting cervical cells via a
brush, stick or swab that is used to loosen and then collect cells
that can be examined microscopically.
[0007] Typically, the PAP test is performed by inserting a speculum
into the patient's vagina to expose the cervix. The surface of the
cervix is then scraped by a brush, stick or swab and the exfoliated
cells thereby collected are smeared upon a microscope slide for
cytological examination. There are a number of drawbacks to the PAP
test.
[0008] The PAP test is nearly always performed in a physician's
office by a gynecologist or other medical professional. Thus, the
test is not inexpensive, as the expense of an office visit is
necessarily included. This means that the PAP test is not readily
available to all women, for example, as would be desired in public
health screening. Further, the test is considered by many women to
be uncomfortable and embarrassing. Some women have religious
beliefs that prohibit gynecological procedures such as the PAP
test.
[0009] Although most medical professionals consider the PAP test
something that should be done throughout the later stages of a
woman's life, many women avoid the gynecologist once they are done
bearing children. Thus, a need remains for an apparatus that will
extend cervical screening to more women by permitting women to
easily and comfortably obtain a cervical cell sample without
requiring a physician's assistance. Such an apparatus could be
used, for example, to augment traditional PAP tests by providing
cervical cell screening to women who would otherwise not have a PAP
test. A personal cervical cell collector could also be used to
confirm a previous diagnosis.
SUMMARY OF THE INVENTION
[0010] Accordingly, the invention relates to a personal collector
that can easily and comfortably be used by a woman in the privacy
and comfort of her own home. Once the cervical sample is obtained,
it can be forwarded to a physician's office or other lab location
for analysis. If the subsequent analysis proves positive, the woman
can then be seen by a physician.
[0011] The invention can be found in a cervical cell collection
apparatus that is intended for personal use. The collection
apparatus includes an outer guide assembly curved to approximate
the natural curvature of a woman's vagina. An inner sampling
assembly positioned within the outer guide assembly is also
included. The inner sampling assembly includes a collector pad and
is moveable from a first position in which the collector pad is
located within the outer guide assembly to a second position in
which the collector pad is located outside the outer guide
assembly. The inner sampling assembly is configured to collect
cervical cells while in the second position while the collector pad
is protected against unwanted sample contamination while in the
first position.
[0012] In another embodiment, the collection apparatus includes an
outer guide assembly curved to approximate the natural curvature of
a woman's vagina, wherein the outer guide assembly includes a
protective tip. An inner sampling assembly positioned within the
outer guide assembly is also included. The inner sampling assembly
includes a flexible shaft bearing a collector pad at a first end
and a gripping structure at a second end, and is moveable from a
first position in which the collector pad is located within the
outer guide assembly to a second position in which the collector
pad is located outside the outer guide assembly. The inner sampling
assembly is configured to collect cervical cells while in the
second position while the collector pad is protected against
unwanted sample contamination while in the first position.
[0013] The invention is also found in a personal cervical cell
collection kit that includes a personal collector and a fixative
canister. The personal collector is as described above, while the
fixative canister includes an outer shell and an inner cap that
fits within the outer shell but is configured to receive the
protective tip of the personal collector. The fixative canister
also includes a unit dose container that contains a volume of
fixative and that has an easily piercable or frangible segment. An
outer cap that is configured to cover an end of the outer shell is
also included.
[0014] The invention is also found in a method of obtaining a
cervical cell sample without requiring the assistance of medical
personal. The method includes obtaining a kit having a personal
collector and a fixative container, wherein the personal collector
includes a sampling collector pad. The personal collector is
inserted into the vagina until the personal collector contacts the
cervix, at which point mucus is removed from the cervix. The
sampling collector pad collects a cervical cell sample and is then
withdrawn back into the personal collector, which is then withdrawn
from the vagina. The sampling collector pad is inserted into the
fixative container to preserve the cervical cell sample.
[0015] In another embodiment, the personal collector includes a
protective tip that serves to remove mucus from the cervix prior to
sampling, thereby yielding a cleaner sample that is less likely to
contaminated.
[0016] Other features and advantages of the present invention will
be apparent from the following detailed description and
drawings.
BRIEF DESCRIPTION OF THE FIGURES
[0017] FIG. 1 is a perspective view of a personal collector in
accordance with a preferred embodiment of the invention.
[0018] FIG. 2 is a perspective view of the outer guide assembly of
the personal collector shown in FIG. 1.
[0019] FIG. 3 is a perspective view of the inner sampling assembly
of the personal collector shown in FIG. 1.
[0020] FIG. 4 is a partial cutaway view of the personal collector
of FIG. 1, illustrating the packed or retracted position of a
particular embodiment of the collector pad.
[0021] FIG. 5 is a partial cutaway view of the personal collector
of FIG. 1, illustrating the extended position of the collector pad
shown in FIG. 4.
[0022] FIG. 6 is a perspective view of the personal collector of
FIG. 1, illustrating an alternate embodiment of the collector pad
in a partially extended position. This Figure also shows a
preferred embodiment of the protective tip located at the distal
end of the outer guide assembly.
[0023] FIG. 7 is a schematic view illustrating placement of the
personal collector of FIG. 1 just prior to insertion by the
user.
[0024] FIG. 8 is a schematic view illustrating placement of the
personal collector of FIG. 1 fully positioned within the vagina of
the user, with the protective tip positioned to remove mucus from
the cervix.
[0025] FIG. 9 is a perspective view of the personal collector of
FIG. 1, shown in conjunction with a preferred sample retention
system.
[0026] FIG. 10 is an exploded perspective view of the sample
retention system shown in FIG. 9.
[0027] FIG. 11 is a sectional view of a personal collector
according to an alternate embodiment of the invention.
[0028] FIG. 12 is a sectional view of the personal collector of
FIG. 11, showing the personal collector as configured while in the
process of being inserted into a vagina.
[0029] FIG. 13 is a sectional view of the personal collector of
FIG. 11, showing the personal collector as temporarily worn within
the vagina, with the insertion devices having been removed and
discarded.
DETAILED DESCRIPTION OF PRESENTLY PREFERRED EMBODIMENTS
[0030] The invention concerns a personal collector that a woman can
use in the privacy of her own home to collect cervical cell samples
in a simple and comfortable manner. Preferably, the cervical cell
samples are collected in such a way as to minimize or even
eliminate possible contamination of the sample with other materials
typically present in the vaginal tract. Once collected, the
cervical cell samples are preferably transferred into a device
suitable to preserve the cells until the cells can be further
processed and analyzed.
[0031] A typical manner of processing and analyzing cervical cell
samples is to place the cells onto a microscope for morphological
examination in which a technician examines the cells for visible
signs of abnormality. If such are found, additional testing of the
patient may be required. This general analysis is typical of the
testing used to examine PAP smear samples, as is well known by
those of skill in the art.
[0032] Referring now to the drawings, wherein similar reference
numerals indicate similar elements in a number of drawings, there
is shown in FIG. 1 a personal collector 100 in accordance with a
preferred embodiment of the present invention. The personal
collector 100 includes an outer guide assembly 120 and an inner
sampling assembly 110. A handle 112 is located at the proximal end
102 of the inner sampling assembly 110. In this, and throughout
this disclosure, a proximal position is considered to be closest to
the end of the personal collector 100 that remains outside the body
(the handle) while a distal position is considered to be the
opposite end, or the portion of the personal collector 100 that
enters the body.
[0033] Outer guide assembly 120 (see also FIG. 2) is a hollow,
substantially circular cylinder that is preferably is curved to
approximate the natural geometry of the vaginal tract when a woman
is in a sitting or standing position, as these positions are more
likely to be used by the woman in taking a cervical cell sample.
While the outer guide assembly 120 can also be substantially
linear, such a shape is more suited to the vaginal tract geometry
obtained when the woman being examined is in the standard position
for a gynecological examination, i.e. in the stirrups.
[0034] The outer guide assembly 120 can be gently curved over its
entire length, but that can perhaps lead to difficulties in guiding
the assembly into and through the vagina during use, as well as
being able to rotate the personal collector 100 once it has been
fuly inserted into the vagina. Therefore, it is preferable that the
outer guide assembly 120 include a substantially linear portion 124
and a curved portion 126 as illustrated in, for example, FIG. 2.
Preferably, the linear portion 124 has a length of from about 25 to
about 75 millimeters while the curved portion preferably has a
length of about 20 to about 60 millimeters. If the entire length of
the outer guide assembly 120 is curved, it preferably has a radius
of curvature of about 30 to 70 millimeters. If, however, only a
portion is curved, that curved portion 126 preferably has a radius
of curvature of about 40 to 60 millimeters.
[0035] As illustrated, the outer guide assembly 120 is
substantially circular in cross-section. It has been found that a
substantially circular cross-section provides for the most
efficient use of the interior volume of the outer guide assembly
120. This shape also has manufacturing advantages. One of skill in
the art will realize, however, that the outer guide assembly 120
can have other cross-sectional geometries and still function as
intended.
[0036] The outer guide 120 also has a protective tip 130 located at
the distal end 104 (as seen in FIG. 1) of the personal collector
100. The protective tip 130 provides several functions. It serves
to protect the collector pad 430 as seen in FIG. 4 during both
insertion into and withdrawal from (the personal collector 100) the
user's vagina. Preferably, the protective tip 130 also serves to
remove at least a portion of the mucus and other material typically
found on and near the cervix. The protective tip 130 can be coated
with or even be made from a substance that can function as desired.
This can include cilia-like structures or fabric-like materials
such as flocking.
[0037] FIG. 6 illustrates how a preferred embodiment of the
protective tip 130 functions. Preferably, the protective tip 130
has a number of individual sections or petal-like structures 132
that can open as the inner sampling assembly 110 is moved towards
an extended position in which the collector pad 630 has moved
beyond the confines of the outer guide assembly 120 and is
positioned for cervical cell sampling. Preferably, the individual
sections 132 can return to their original positions (as in FIG. 1)
once the inner sampling assembly 110 is retracted. In a preferred
embodiment, the individual sections 132 are biased in a closed
position.
[0038] The outer guide assembly 120 preferably includes a finger
grip 122 which, as described in greater detail hereinafter,
provides assistance in positioning and operating the personal
collector 100. Similarly, inner sampling assembly 110 has a handle
112 that will also be described in greater detail.
[0039] Inner sampling assembly 110 is perhaps best illustrated in
FIG. 3. In a preferred embodiment, the inner sampling assembly 110
includes a smooth, substantially rigid cylindrical portion 114 and
a flexible portion 116. The flexible portion 116 provides the inner
sampling assembly 110 with the flexibility that is beneficial for
allowing telescopic movement within the outer guide assembly 120
while the substantially smooth portion 114 provides the stiffness
useful in forcing the inner sampling assembly 110 through the outer
guide assembly 120.
[0040] Alternatively, the flexible portion 116 can extend the
entire length of the inner sampling assembly 110, from the handle
112 located at the proximal end 302 to the collector mounting point
118 located at the distal end 304, or any fraction thereof.
Adjustments made in the length of the flexible portion 116 relative
to the smooth, relatively rigid portion 114 can provide a desired
level of flexibility in the inner sampling assembly 110
independently of the particular material used to form the inner
sampling assembly 110. One of skill in the art will realize that
flexible portion 116 does not have to be ribbed (as illustrated),
but rather can be made from a material having the desired
flexibility.
[0041] Both the inner sampling assembly 110 and the outer guide
assembly 120 can be made from a variety of different materials.
Preferably, these materials are biocompatible, meaning that they
neither negatively impact the internal tissues of the body nor are
themselves effected by bodily tissues and fluids. A number of
plastics qualify, including, for example, polyethylene, polyvinyl
chloride (PVC) and polystyrene. One of skill in the polymer field
can readily create a material having desired characteristics from a
variety of different plastics, simply by fine tuning the processes
used to create them. It is possible that either the inner sampling
assembly 110, outer guide assembly 120 or both be made from
cardboard or other paper stock products exhibiting desirable
strength, flexibility and resistance to moisture.
[0042] The handle 112 is located at the proximal end 302 (as shown
in FIG. 3) of the inner sampling assembly 110. Use of the handle
112 will be described hereinafter in greater detail, although it
can be said that the handle aids in operation of the personal
collector 100. A preferred embodiment of the handle 112 is seen in
the Figures, in which the handle 112 is seen as an enlarged portion
of the smooth portion 114 of the inner sampling assembly 110. The
handle 112 can be formed as an integral part of the smooth portion
114 or it can be formed separately and then adhered to the inner
sampling assembly 110. The handle 112 as shown is scalloped,
although a variety of other shapes and textures are possible, as
known to those of skill in the art. The handle 112, the rigid
portion 114 and the flexible portion 116 are together considered to
provide a grippable pusher that is used (as described hereinafter)
to control the position of the collector pad 430.
[0043] A collector mounting position 118 is found at the distal end
304 of the inner sampling assembly 110 and serves as a location at
which the collector pad 430 can be mounted. FIGS. 4 and 5
illustrate the retracted and extended positions, respectively, of a
preferred collector pad 430 while FIG. 6 illustrates the extended
position of an alternative collector pad 630. The collector pad 630
comprises a substantially disk-shaped portion 632 and a centrally
located raised portion 634. Preferably, the disk-shaped portion 632
is sized and configured to sample primarily the outer or
ecto-cervical region while the raised portion 634 is sized and
configured to sample primarily the inner or endo-cervical region.
Preferably, both portions 632, 634 are able to sample the
transition zone that lies between the inner and outer portions of
the cervix. While not explicitly illustrated, the disk-shaped
portion 632 and centrally located raised portion 634 can include,
respectively, a large foam disk as portion 632 and a smaller foam
disk as portion 634.
[0044] While several specific collector pad shapes are illustrated,
the collector pad can have a variety of different geometric
configurations. The limiting factor is whether or not the collector
pad presents a sufficient surface area to the cervix for
exfoliating and collecting cervical cells. For example, a
cone-shaped collector pad could be used, with the large end of the
cone presented towards the cervix if primarily ecto-cervical
sampling is desired. Alternatively, the small end of the cone can
be presented towards the cervix to enable primarily endo-cervical
sampling.
[0045] The collector pad 430 can be made from a variety of
materials, although foam has been found to be most useful. The foam
can be open-celled or closed-cell, although open-celled foam is
preferred. Other suitable materials include cloth and open-celled
porous materials such as sponge. The collector pad 430 may be
uncoated, or at least part of the collector can be coated with a
substance such as collagen that enhances either the cell
exfoliation or cell adherence characteristics of the collector. The
collector pad 430 can also be coated with an adhesive.
Alternatively, it is envisioned that at least part of the collector
could instead be coated with a substance that would instead inhibit
adherence by non-cervical cell materials.
[0046] The collector pad 430 is attached to the distal end 504 of
the inner sampling assembly 110 through a snap-fit or other
suitable connection. This is seen in FIGS. 4 and 5 as connection
432, which operably connects the collector pad 430 to the collector
mounting position 118 (see FIG. 3). This connection could also be
made with adhesives, although it is preferable in at least one
embodiment of the invention that the collector pad be detachable
once a cervical cell sample has been obtained. In a particular
embodiment of the invention, an extraction string 1126 is attached
to the collector pad 1130 (see FIG. 11, for example).
[0047] The inner sampling assembly 110 is configured to be moveable
within the outer guide assembly 120. As such, the collector pad 430
is positioned within the outer guide assembly 120 both before use
and after a sample is taken. FIG. 4 illustrates how a preferred
collector pad 430 is positioned within the protective tip 130.
Preferably, the collector pad 430 is folded in such a way as to
position the collector pad 430 in front of the inner sampling
assembly 110. This can be seen in FIG. 4, where the collector pad
430 is folded into individual folds 434, each of which are located
beyond the inner sampling assembly. In fact, the connection 432 is
positioned between the distal end of the inner sampling assembly
110 and the collector pad 430.
[0048] Operation of the personal collector 100 is as follows.
Preferably, the user will obtain the personal collector 100 still
attached to the fixative and protective canister 1000 as
illustrated in FIG. 9.
[0049] In FIG. 7, the personal collector 100 is arranged for
insertion. The inner sampling assembly 110 is in a retracted
position with respect to the outer guide assembly 120. At this
point, the personal collector 100 is positioned just outside the
vagina 710. The relative position of the cervix 720 is seen as well
in this rendition of the female anatomy 700. The personal collector
100 is then fully inserted into the vagina 710. Because the patient
is unable to determine the position of the personal collector 100
in relation to her cervix 720, it is preferable that the patient
simply insert the personal collector 100 as far as possible.
Insertion is preferably limited by the protective tip 130
contacting the cervix 720, as illustrated in FIG. 8. This Figure
also illustrates how the preferred curvature of the outer guide
assembly 120 assists in negotiating the vaginal tract. Next, the
user rotates the outer guide assembly 120 by grasping the finger
holds 122 that are provided for that purpose. This is done so that
the protective tip 130 can remove at least some of the mucus and
other material typically found on and near the cervix 720
[0050] Next, the personal collector 100 is withdrawn slightly and
the handle 112 is pushed until the collector pad 430 emerges from
the outer guide assembly 120 and makes contact with the cervix 720.
FIG. 6 illustrates how the protective tip 130 opens to permit the
collector pad 430 to emerge.
[0051] With the collector pad 430 in full contact with the cervix
720, the user rotates the inner sampling assembly (and thus the
collector pad 430) via handle 112. Then, the collector pad 430 is
retracted back into the protective tip 130 by pulling back on the
handle 112. At this point, the personal collector 100 can be
removed from the vagina 710. The collector pad 430 is inserted into
the fixative canister 1000 and preferably snaps into place. The
remainder of the inner sampling assembly 110 and outer guide
assembly 120 can be discarded. The cap 920 is then placed over the
outer shell 910 of fixative canister 1000, which can then be sent
for testing.
[0052] The fixative canister 1000, which is best described in
reference to FIG. 10, serves to protect the protective tip 130
during shipping and handling. The fixative canister is removed
prior to use of the personal collector 100, as referenced
previously. The fixative canister 1000 includes an outer shell 910,
an inner cap 940 and a fixative dose container 930. The fixative
dose container 930 includes a liquid fixative and has a pierceable
seal 932 that will be punctured when the collector pad 430 is
inserted. The fixative preferably includes mucolytic agents and red
blood cell lysing agents, among others.
[0053] After sampling is complete, the collector pad 430 is
reinserted into the fixative assembly 1000 so that the protective
tip 130 is once again positioned within the inner cap 940. The
collector pad 430 is then pushed firmly into the canister assembly
1000, thereby puncturing the fixative dose container 930 and
allowing fixative to flow into the inner cap 940 and over the
collector pad 430. Preferably, the inner sampling assembly 110 and
the outer guide assembly 120 can be snapped off and discarded at
this point. Finally, the cap 920 is placed over outer shell 910 to
protect the sample.
[0054] An alternative embodiment of the invention involves a device
that provides for the cell collector to remain in contact with the
cervix for an extended period of time. There are a number of
reasons why a physician may decide that extended sampling time is
desirable, such as a low cell exfoliation rate, or if there is a
low volume of cells within the exfoliated material.
[0055] The cell collector is preferably made from a thin-walled
sponge material that is designed to accommodate an extraction
string that is attached to an internal portion of the collector.
The external part of the collector and its attached string are
connected to a ring that is left in place as long as the collector
is being worn within the vagina.
[0056] Preferably, the collector is inserted through a
biodegradable hollow tube. The collector and tube can be provided
as a ready for insertion package, with the tube and collector
sealed within a disposable sterile bag or pouch. Once the collector
has been inserted, the tube can be removed and disposed of, thereby
leaving the collector in vivo for a given period of time. The
collector can remain in vivo, in contact with the cervix, for as
long as necessary to obtain a suitable sample. Preferably, this
period of time is about 30 minutes.
[0057] Once the collector has been in contact with the cervix for a
desired period of time, it is removed by pulling the ring through
the tube, thereby turning the collector inside-out to protect the
sample. The string is preferably attached to the non-expanded tube,
so when the tube (ring) is pulled the collector (with the cervical
sample contained therein) is pulled into the tube which is
preferably sealed at the external (end opposite the vagina) end.
Once the tube has been fully extended and the collector is inside
the expanded tube, a cap or other closure is placed on the other
(vaginal) end of the tube. When the cap or other closure is
secured, a seal is broken in the cap or closure that releases an
encapsulated preservative solution.
[0058] In an alternative embodiment, the collector can be fashioned
with a ring structure along its outer diameter. In this case, the
collector can be flattened and inserted into the vagina and placed
in contact with the cervix much like a contraceptive diaphragm. The
collector is preferably worn for a particular period of time,
during which normal body motion will cause the collector to
exfoliate cells from the cervix. Once the sampling period has
ended, the user can remove the collector via an attached string or
extended tab that can simply be grasped and pulled.
[0059] Preferably, the attached string or extended tab is attached
at the center of the collector. If so, removal of the collector by
pulling on the string or tab will essentially turn the collector
inside-out. This protects the cervical cell sample from
contamination by contacting the vaginal walls.
[0060] The sealed tube can be labeled and mailed in to a physician
or other healthcare provider. In a preferred embodiment, it is
envisioned that the sealed tube can be mailed directly to a lab for
analysis, bypassing the physician. The personal collector described
in this embodiment is intended to sample only the exocervical area.
Thereby, the collector preferably forms (when released) a flexible
cup that is about 30 to 35 millimeters in diameter and about 4-6
millimeters thick. Preferably, the sampling surface is mildly
abrasive to assist in exfoliating cervical cells for sampling.
[0061] In a preferred embodiment, the collector is a thick,
relatively flat elastomeric washer. The collector can have several
laminate layers or can be a single material such as a foam. If a
laminate is used, an inner layer can be a water impermeable polymer
while the outer layer can be a sponge.
[0062] Returning to the Figures, the alternative embodiment
described herein is illustrated in FIGS. 11-13. A guide tube 1102
that has distal petal elements 1104 compresses and surrounds the
compressed foam cylinder 1108, which will function to hold the
device within a user's vagina. An insert tube 1110 is located
within the compressed foam cylinder 1108 and extends to provide a
handle portion 1112. On the exterior of the tube 1102, an insertion
location indicia ring 1116 provides guidance for proper device
insertion and location. Although not required, it is preferable
that the device include embossments 1118, which provide a grip
area. At the distal end 1120, a collector sponge 1130 is mounted
onto a preferably rigid disk 1124. Preferably, the disk 1124 is
engaged by the insert tube 1110 but is not permanently attached to
the disk 1124. A withdrawal string 1126 extends from the disk 1124
down through the guide tube 1110.
[0063] In use, the assembled unit shown in FIG. 11 is inserted by
the user into her vagina. The unit is inserted up to a depth
equivalent to the location of the insertion indicia ring 1116.
Then, while holding the insert tube 1112 in place with one hand,
the user can gently remove the guide tube 1102 to leave the now
un-compressed, radially expanded foam cylinder 1108 in place.
Preferably, the foam cylinder 1108 is sized such that once
expanded, it is firmly held in place by the vaginal walls (not seen
in the Figures), as suggested in FIG. 12. Over a period of time,
exfoliated cervical cells are collected on the sponge 1130.
[0064] As suggested in FIG. 13, the proximal end of the foam
cylinder 1108 terminates in an open-ended ring or cap 1140 within
which is a flexible membrane sack. When the user is ready to
withdraw the sponge 1130 from her vagina, she holds the cap 1140
with one hand and draws down on the withdrawal string 1126 with her
other hand. This slightly re-compresses the foam cylinder 1108 both
radially and axially so as to pull the foam 1108 and collector disk
1124 into the membrane sack. This secures and protects the cervical
cell sample.
[0065] The collector pad 430, 1130 can also be used to apply
medications directly to the cervix. An example of a suitable drug
is .delta.-amino levulinic acid, also known as ALA. This is a
photodynamic therapy agent. One of skill will realize that a
variety of other medications can also be applied in this
manner.
[0066] While the invention has been described with reference to
specific embodiments, it will be apparent to those skilled in the
art that many alternatives, modifications and variations may be
made. Accordingly, the present invention is intended to embrace all
such alternatives, modifications and variations that may fall
within the spirit and scope of the appended claims.
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