NZ621851B2 - Cervical cell tissue self-sampling device - Google Patents
Cervical cell tissue self-sampling device Download PDFInfo
- Publication number
- NZ621851B2 NZ621851B2 NZ621851A NZ62185112A NZ621851B2 NZ 621851 B2 NZ621851 B2 NZ 621851B2 NZ 621851 A NZ621851 A NZ 621851A NZ 62185112 A NZ62185112 A NZ 62185112A NZ 621851 B2 NZ621851 B2 NZ 621851B2
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- New Zealand
- Prior art keywords
- tool
- cellular
- cervical
- insertion tube
- aligning
- Prior art date
Links
- 238000005070 sampling Methods 0.000 title claims abstract description 167
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- 238000003780 insertion Methods 0.000 claims abstract description 169
- 239000000523 sample Substances 0.000 claims abstract description 65
- 210000001215 Vagina Anatomy 0.000 claims description 26
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- 230000000875 corresponding Effects 0.000 claims description 8
- 238000009595 pap smear Methods 0.000 abstract description 20
- 230000001419 dependent Effects 0.000 description 15
- 210000003679 Cervix Uteri Anatomy 0.000 description 12
- 238000004458 analytical method Methods 0.000 description 7
- 239000000463 material Substances 0.000 description 7
- 206010008342 Cervix carcinoma Diseases 0.000 description 6
- 201000010881 cervical cancer Diseases 0.000 description 6
- 201000011510 cancer Diseases 0.000 description 5
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/02—Instruments for taking cell samples or for biopsy
- A61B10/0291—Instruments for taking cell samples or for biopsy for uterus
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/02—Instruments for taking cell samples or for biopsy
- A61B2010/0216—Sampling brushes
Abstract
Disclosed is a device, a kit, and a method of use thereof, for self-administration and collection of cervical cell tissue samples such as for Pap smear testing. The device comprises an insertion tube (20), an elongated cervical alignment tool (40) and an elongated cellular sampling tool (60). The insertion tube comprises a passage containing the cervical aligning tool therein. The cervical alignment tool comprises with an aligning probe (48) and a handle (46), separated with a body (50) therebetween. The cellular sampling tool comprises a cellular adhesion surface (68) and a handle (66). The cervical aligning tool handle is disposed outside the insertion tube passage and is moveable between a first position, wherein the probe is within the passage, and a second position, wherein the probe extends from the passage to engage a cervical fornix of a patient. The elongated cellular sampling tool is shaped for insertion within the passage, upon a portion of the aligning tool and within the aligning tool handle. The handle of the cellular sampling tool extends from the passage and is releasably movable between a first position, for insertion, and a second position, for sampling. The sampling tool can be rotatably engaged with the alignment tool, such that the sampling tool may be rotated during sample collecting. The aligning probe and cellular adhesion surface can be selectively movable relative to the insertion tube to improve accuracy of the testing and user safety. sertion tube comprises a passage containing the cervical aligning tool therein. The cervical alignment tool comprises with an aligning probe (48) and a handle (46), separated with a body (50) therebetween. The cellular sampling tool comprises a cellular adhesion surface (68) and a handle (66). The cervical aligning tool handle is disposed outside the insertion tube passage and is moveable between a first position, wherein the probe is within the passage, and a second position, wherein the probe extends from the passage to engage a cervical fornix of a patient. The elongated cellular sampling tool is shaped for insertion within the passage, upon a portion of the aligning tool and within the aligning tool handle. The handle of the cellular sampling tool extends from the passage and is releasably movable between a first position, for insertion, and a second position, for sampling. The sampling tool can be rotatably engaged with the alignment tool, such that the sampling tool may be rotated during sample collecting. The aligning probe and cellular adhesion surface can be selectively movable relative to the insertion tube to improve accuracy of the testing and user safety.
Description
CERVICAL CELL TISSUE SELF-SAMPLING DEVICE
CROSS-REFERENCE TO RELATED APPLICATIONS
This application claims priority to U.S. Provisional ation Serial No.
61/532,724, filed September 9, 2011, the entire contents of which are incorporated by
reference herewith.
FIELD OF INVENTION
The present invention relates to gynecological medical apparati and
methods of use. More particularly, the present invention es a device for self-
collecting cervical tissue samples for Pap test screening for cervical cancer and other
infectious diseases.
BACKGROUND OF THE INVENTION
The Pap test (a/k/a Pap smear, cervical smear, or Papanicolaou smear) is an
important e gynecological test usually performed annually to screen for early
detection of cervical, uterine, and/or vaginal cancer. The Pap test is not intended to be a
definitive diagnostic test, but rather a risk assessment-oriented, basic screening ure.
The Pap test is an anatomic pathology assay, where human tissue, cells, and/or secretions
from the site of a potential cancer, such as the cervical region, are viewed under a
microscope by a trained laboratory professional in search of cellular morphologic changes
that evidence, to varying degrees along a standardized continuum of severity (e.g. , the
Bethesda System), the likely existence and ssion of cervical cancer.
A ve Pap test where suspicious cellular changes have been identified
is lly followed-up with a colposcopy and/or definitive biopsy. Importantly, given
the inherently and otherwise unavoidably imprecise nature of the Pap test, the Pap test
owes its ary efficacy in ting cervical cancer as much, if not more, to the sheer
repetitiveness of the ure over the course of a woman's life, than to the sensitivity,
per se, of any single Pap test. According to cytology experts, the statistical confidence
level of an accurate Pap test result rises from a low of 60-70% to upwards of 98% after
just three consecutive annual Pap tests.
For this reason, health care standards-setting organizations, such as the
American Cancer Society, generally recommend regular (e.g. , annual) Pap g for all
women, and for sexually active teens. The American Cancer society recommends that
normal women under forty have a Pap smear taken every three years after three
consecutive yearly normal Pap smears. However, ing to a Gallup poll conducted by
the e of American Pathologists (CAP), nearly 40% of those women polled had not
had a Pap test within the past year. For many women, the routine screening test would be
regularly performed if it could be done in a non-intrusive, private . Screening for
Cervical Cancer, in Common Screening Tests, David M. Eddy, MD, PhD, Editor, Chapter
, pages 255-283 (1991).
The Pap test is traditionally taken by a gynecologist by inserting a
speculum into the patient's vagina in a manner to expose the cervix of the uterus for
sampling , in particular for sampling cells from the endocervical canal and al
os. To accomplish this, the woman must remain in a reclining position. Various types of
speculums and us cervical scrapers or probes have been developed for this
purpose. The cytologic specimens collected are then placed upon microscope slides for
manual or automated reviewing. They are evaluated for hormonal levels and to ine
the presence of cancers, precancers and vaginal infections. The test aims to detect
potentially pre-cancerous changes (called cervical intraepithelial neoplasia (CIN) or
cervical dysplasia), which are very often caused by sexually transmitted human
papillomaviruses. The test remains an effective, widely used method for early detection of
pre-cancer and cervical cancer. The test may also detect infections and abnormalities in
the endocervix and endometrium.
Most of the prior art equipment has been designed for use by gynecologists
and is not suitable for use solely by the t upon herself. There have been previous
ts to develop Pap test apparatus that could be self-administered in order to achieve
an economic efficiency by avoiding physician assistance, and ed healthcare through
widespread availability. However, there remains a need to e a more accurate, non-
traumatic, self-administered apparatus and method for the collection of cervical tissue
samples for cytologic tion.
SUMMARY OF THE INVENTION
This t invention provides a cervical cell tissue self-sampling device,
and method of use thereof, that can be used at home or any location of a patient's
choosing. The inventive device and method of self-administration and collection of
vaginal cervical cell tissue samples provide an ent tool for privately performing a Pap
smear or tissue sample collection without the need for assistance by a gynecologist or
other medical practitioner.
In certain embodiments, the present invention provides a device for
collecting a cervical cell tissue sample comprising an elongated insertion tube shaped for
insertion into the vagina of the patient and having a proximal end, a distal end, an exterior
surface and an interior surface extending therethrough defining a passage.
The device further comprises an elongated al aligning tool shaped for
insertion within the e of the insertion tube, and having a proximal end with a handle
(also referred to as an aligning tool handle, or g") thereon, a distal end with a
cervical aligning tool (also referred to as an aligning spoon) thereon, and a body
therebetween, wherein the handle is disposed outside the proximal passage of the insertion
tube for manipulation by the user. The aligning tool is movable between a first position
for insertion, wherein the distal cervical aligning probe is contained within the passage of
the insertion tube, and a second position for cervical cap alignment, wherein the cervical
aligning probe es to extend distally from the passage of the insertion tube to engage
the posterior cervical fornix of the patient, in order to expose the os for cell specimen
collection.
The device further comprises an elongated cellular ng tool shaped
for insertion within the passage of the ion tube and upon a portion of the body of the
elongated aligning tool within the advanceable U-Ring handle. The cellular sampling tool
has a proximal end with an advancing haped handle n, and a distal end with a
ar adhesion e, such as a small brush, thereon. The advancing handle of the
sampling tool extends from the proximal passage of the insertion tube proximal to the U-
Ring of the aligning tool for manipulation by the user. The cellular sampling tool is
dependently, or releasably, movable between a first position for insertion wherein the
distal cellular on surface is contained within the passage of the insertion tube, and a
second position for cervical cell tissue sampling n the distal cellular adhesion
surface extends distally outside the e of the insertion tube.
The movement of the cervical aligning tool and/or the cellular sampling
tool is dependent upon the user selective release of a retaining mechanism by the direct or
indirect action of the patient or other person using the device. In certain embodiments, the
distal movement of the cervical ng tool and/or the cellular sampling tool is
dependent upon the patient removing, or releasing, a handle retaining safety cover which
frictionally s the insertion tube and the sampling tool and/or the cervical ng
tool in a fixed relative position until the retaining cover is d. In certain other
embodiments, the distal movement of the cellular sampling tool is dependent upon the
patient manually disengaging a release tab on the cellular sampling tool in selective
communication with the insertion tube. In other ments, the distal movement of the
cellular ng tool is dependent upon the patient moving the aligning tool into the
second position, which indirectly releases a retaining pin on the ng tool from a fixed
position. These and other configurations for requiring the cellular sampling tool and/or
the al aligning tool to be dependently or selectively releasably movable will be
apparent to one of skill in the art in view of the present disclosure. The dependency of
requiring the release of a retaining mechanism to allow distal movement of the cervical
aligning tool and/or the cellular sampling tool protects the patient's tissue during insertion
of the device and prevents premature re of the ar adhesion surface within the
vaginal wall to avoid non-specific contamination of the cervical cells of interest.
Following release of a retaining mechanism, the cellular sampling tool can
be fully or partially movable distally and rotatable within the insertion tube and upon the
spoon-shaped cervical aligning tool and U-Ring for gathering cervical cellular samples
from and adjacent to the cervical os. In certain embodiments, the cellular adhesion surface
is a brush element. In certain embodiments, the distal end of the brush element has a
cone-shaped distal end with a high density of flexible bristles. In other embodiments, the
cellular on e is ble from the cellular sampling tool and the rest of the
device for storage and transportation of the cervical cell samples to a laboratory for
analysis. In certain embodiments, the cellular sampling tool further comprises a retaining
sleeve slideably ed upon the ng tool between a first position for retaining the
adhesion surface and a second position for releasing the adhesion surface. In certain
ments, the cellular sampling tool allows release of the adhesion surface by
unscrewing the threaded distal end.
In certain embodiments, the cervical ng probe is spoon-shaped having
a convex curvature concentric with the distal end of the insertion tube. In other
embodiments, the cervical aligning tool further comprises an aligning extension element,
or keel, extending along a portion of the body which engages an elongated alignment
groove extending from a portion of the interior surface of the insertion tube.
In certain embodiments, the U-Ring of the cervical aligning tool engages
the al portion of the passage of the ion tube to impede further distal
movement of the cervical aligning tool within the vagina. In certain embodiments, the
advancing handle of the cellular sampling tool engages the al portion of the U-Ring
of the cervical aligning tool to impede further distal movement of the cellular sampling
tool within the vagina.
In certain ments, the proximal end of the insertion tube r
comprises an r insertion shield peripherally extending from the exterior surface to
impede insertion within the vagina beyond a predetermined depth. In certain
embodiments, the annular insertion shield extends wider along a surface corresponding to
the anterior of the vaginal opening and narrower along an opposite surface ponding
to the posterior of the vaginal opening to guide the patient as to the proper orientation for
insertion. In certain embodiments, the proximal end of the insertion tube further
ses a plurality of exterior ribbed gripping surfaces proximal to the insertion shield.
In n embodiments, the proximal end of the insertion tube has a diameter greater than
the distal end of the insertion tube.
In certain embodiments, the device of the present invention further
ses a handle retaining cover having a proximal end, a distal end, and comprising an
insertion tube engaging surface, a al aligning tool engaging surface, and a cellular
sampling tool engaging surface. In n embodiments, the handle retaining cover is
removably engageable with the device such that relative movement of the cervical
aligning tool and the cellular ng tool within the ion tube is impeded until the
handle retaining cover is physically removed by the user.
The present invention further provides a method of collecting a cervical
and/or vaginal tissue sample from a patient using the device of the present invention. The
inventive method comprises the steps of (a) inserting into the vagina of the patient a
device of the present invention; (b) advancing the U-Ring of the cervical aligning tool
distally from within the insertion tube in the first position to the second position for
cervical cap alignment to engage the posterior cervical fornix of the patient; (c) moving
the ted cellular sampling tool ly from the first position to the second position
for al cell tissue sampling; (d) rotating the cellular sampling tool, preferable two full
rotations in each direction (clockwise and counter-clockwise), to e cervical cell
tissue at or within the patient's os onto the cellular adhesion surface; (e) moving the
elongated cellular sampling tool proximally from the second position to the first position
to shield the cervical tissue sample within the insertion tube; and (f) withdrawing the
device from the vagina of the patient. In certain embodiments, the method also comprises
the additional step, after step (a), of selectively disengaging a retaining mechanism on the
device for user ent e of the al ng tool and/or the cellular ng
tool, such as by removing the handle retaining cover, or in alternative embodiments
depressing a release lever.
In certain embodiments, the inventive method further comprises the later
steps of either removing cervical tissue from the cellular adhesion surface by rinsing in a
preservative solution, or separating the cellular adhesion surface from the cellular
sampling tool; and placing the cellular adhesion surface or the cells thereon in a container
of cellular preservative for storage and transportation to a laboratory for analysis.
The present invention r provides a kit for cervical cell tissue sampling
comprising the device of the present invention, a resealable container of cellular
vative shaped to e the cellular sampling tool cellular adhesion surface or the
cells therein, and instructions for use of the device to obtain a cervical tissue sample and
preserve the sample in the container. In certain embodiments, the kit further comprises a
plurality of replacement cellular on surfaces (e.g., brushes) and a plurality of
containers of cellular preservative.
BRIEF DESCRIPTION OF THE DRAWINGS
Having thus described various embodiments of the ion in general
terms, reference will now be made to the accompanying drawings:
shows an overhead/top view of the cervical cell tissue self-
sampling device, according to one embodiment of the present invention.
FIG. IB shows a side view of the cervical cell tissue self-sampling device,
ing to one embodiment of the present invention.
shows a proximal end view of the cervical cell tissue self-sampling
device, ing to one embodiment of the present invention.
shows an exploded top proximal perspective view of the cervical
cell tissue self-sampling device with each component embled, according to one
ment of the present invention.
shows an ed bottom proximal perspective view of the
cervical cell tissue self-sampling device with each component disassembled, according to
one embodiment of the present invention.
shows a detailed top proximal ctive view of the proximal
end of the insertion tube, according to one embodiment of the present invention.
shows a longitudinal cross-sectional view of the cervical cell
tissue ampling device in an insertion position with a handle retaining cover attached
thereto, according to one embodiment of the present invention.
shows a longitudinal cross-sectional view of the cervical cell tissue
self-sampling device with the handle retaining cover disengaged, according to one
embodiment of the present invention.
shows a longitudinal sectional view of the cervical cell tissue
self-sampling device, in which the alignment tool is extended for cervical distension,
according to one embodiment of the present invention.
shows a longitudinal cross-sectional view of the cervical cell
tissue self-sampling device, in which the alignment tool and the tissue cellular adhesion
surface are extended into position for collection of cervical s, according to one
embodiment of the present invention.
shows a longitudinal cross-sectional view of the cervical cell
tissue self-sampling device in an insertion position with a handle retaining cover attached
thereto, ing to another embodiment of the present ion.
shows a longitudinal cross-sectional view of the cervical cell tissue
self-sampling device with the handle retaining cover disengaged, according to one
embodiment of the present invention.
shows a udinal cross-sectional view of the cervical cell tissue
self-sampling device, in which the alignment tool is extended for cervical distension,
according to one embodiment of the present invention.
shows a longitudinal cross-sectional view of the cervical cell
tissue self-sampling device, in which the alignment tool and the tissue ar adhesion
surface are extended into position for collection of cervical tissues, according to one
ment of the present invention.
shows a ctive top distal view of the cervical cell tissue self-
ng device in an insertion position with the handle retaining cover attached thereon,
according to one embodiment of the present invention.
shows a perspective top distal view of the cervical cell tissue self-
sampling device with the handle retaining cover disengaged, according to one ment
of the present invention.
shows a perspective bottom distal view of the cervical cell tissue
self-sampling device with the handle retaining cover disengaged, according to one
embodiment of the t invention.
DETAILED DESCRIPTION OF THE INVENTION
It is to be understood that the invention is not limited in its ation to
the details of construction and the arrangement of components set forth in the following
description or illustrated in the drawings.
The present invention provides a cervical cell tissue self-sampling device,
and method of use thereof, that can be dministered by a female at any on
including in the privacy of her own home. The inventive device and method of self-
administration and collection of vaginal cervical tissue samples provide an efficient tool
for privately ming a vaginal tissue sample collection for a Pap smear test without the
assistance of a gynecologist or other medical practitioner. While nce to cervical cell
tissue sampling for a Pap smear test is repeated herein, one of skill in the art will
appreciate that the various embodiments of the device can be used for sampling various
vaginal tissues and fluids upon which any diagnostic test of interest may be conducted.
While the device is primarily intended to be used by the patient herself, the device can also
be used by a nurse, gynecologist or any assisting medical practitioner on the patient, if so
desired.
In certain ments, the t invention provides a device for
ting a cervical tissue sample from a patient comprising an elongated insertion tube
shaped for insertion into the vagina of the patient. The insertion tube has a proximal end,
a distal end, an exterior surface and an interior surface ing therethrough defining a
passage. In certain embodiments, the insertion tube has a diminishing cross-sectional
diameter from proximal end to the distal end for ease of insertion. The insertion tube is
preferably round in a l cross-section, however, may also be any other shape, such as
ovular, nal, or irregular, but which avoids any sharp angles or uncomfortable edges.
The elongated insertion tube can have a length for example in the range of
about 100-220 mm, and an outer diameter that is flared from a smaller distal diameter in
the range of about 10-20 mm to a larger proximal diameter in the range of about 30-50
mm. In certain embodiments, the elongated insertion tube has a length of about 100 mm,
120 mm, 140 mm, 160 mm, 180 mm, 200 mm, or 220 mm, and has an outer diameter of
about 10 mm, 15 mm, 20 mm, 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, or 50 mm. It will
be tood and appreciated by those skilled in the art that the present invention
encompasses various ion tubes with variable lengths and outer diameters that are
suitable for use for ent female patients of different sizes.
The elongated insertion tube, as well as some of the other components can
be made from medical-grade thermoplastics, evidencing the following desired
characteristics: cost effectiveness; lightweight; strength; dimensional stability; low
coefficient of friction/inherent lubricity; soft touch; and dye-dopable. Examples include:
High-density Polyethylene (HDPE); High-density Polypropylene (HDPP);
Polytetrafluoroethylene (PTFE, i.e., TEFLON®); and rigid Polyvinyl de (PVC). The
insertion tube is non-foldable in use, meaning that in normal use under forces applied by
hand it will not collapse, flatten, or fold in on itself, but flexibility and ning can be
provided. The insertion tube of the present invention can also be surface coated with any
materials as needed by the patient, such as vaginal lubricants (e.g., KY®) that help
insertion, ed thereon when the device is made, or prior to insertion.
The device further ses an elongated al aligning tool shaped for
insertion and movement within the passage of the insertion tube. The cervical aligning
tool has a proximal end with a U-shaped handle thereon, a distal end with a cervical
aligning probe n, and a body etween. The cervical aligning tool handle may
be referred to as the "U-Ring" herein for convenience, but it is understood than the handle
is not necessarily U-shaped in the claimed embodiments. U-Ring is disposed outside the
proximal passage of the insertion tube and can be manipulated by the hand of the user
such that the aligning tool is movable between a first position for insertion, wherein the
distal cervical aligning probe is contained and ted from the patient within the
passage of the insertion tube, and a second position for cervical cap alignment, wherein
the distal cervical aligning probe s distally from the passage of the insertion tube to
engage the cervical fornix of the patient to distend the cervix for exposure of the os for
optimum cervical cell tissue sampling.
The body of the cervical aligning tool placed and movable inside the
passage of the insertion tube preferably has a length longer than the insertion tube. In
certain embodiments, the length of the body of the cervical aligning tool can be about 120
mm, 140 mm, 160 mm, 180 mm, 200 mm, 220 mm, or 240 mm. The outer size of the
body of the cervical aligning tool is also smaller than the inner diameter of the insertion
tube so that the body of the cervical aligning tool can move longitudinally from one
position to another position within the insertion tube. In certain embodiments, the length
of the cervical aligning probe is about 5 mm, 10 mm, or 15 mm. It will be understood and
appreciated by those skilled in the art that the lengths and sizes of the cervical aligning
tools correspond to the relative lengths and sizes of the ion tubes used in the present
invention. It will also be understood and appreciated by those skilled in the art that all or
part of the cervical aligning tool may be constructed of any acceptable materials, such as
medical grade thermoplastics and/or other r als, similar to or different from
the materials used for constructing the insertion tube.
The device further comprises an elongated cellular sampling tool shaped
for insertion within the passage of the insertion tube and adjacent to or upon a portion of
the body of the elongated aligning tool. In certain ments, the cervical cellular
sampling tool is at least partially disposed within the advancing U-Ring of the cervical
ent tool. The sampling tool has a proximal end with an advancing handle thereon
for manipulation by the hand of the user, and a distal end with a cellular adhesion surface
n, such as a brush described in more detail below. The ing handle, which
may be ball-shaped, s from the proximal passage of the insertion tube proximal to
the U-Ring of the aligning tool.
The movement of the al ng tool and/or the cellular sampling
tool can be dependent upon the release of a retaining mechanism by the direct or indirect
action of the patient or other person using the device. The cellular sampling tool is
dependently movable between a first on for insertion n the distal cellular
adhesion surface is contained within the passage of the insertion tube, and a second
position for cervical cell tissue sampling wherein the distal cellular adhesion surface
s distally from the passage of the insertion tube. Dependency of the movement of
the cellular ng tool can be subject to direct manual disengagement of a retaining
mechanism to decouple the sampling tool from the insertion tube or cervical alignment
tool, or such as when a handle retaining cover is removed, or indirectly through automatic
engagement or disengagement of a mechanism to decouple the sampling tool from the
ion tube or cervical alignment tool when the alignment tool is moved into the second
position.
The body of the cellular ng tool placed and movable inside the
passage of the insertion tube preferably has a length longer than the cervical aligning tool
and the insertion tube. In certain embodiments, the length of the body of the cellular
sampling tool can be about 125 mm, 140 mm, 160 mm, 180 mm, 200 mm, 220 mm, or
250 mm. The outer size of the body of the cellular sampling tool is also smaller than the
inner diameter of the insertion tube so that the body of the cellular sampling tool can move
longitudinally from one position to another position within the insertion tube. In certain
embodiments, the length of the cellular adhesion surface is about 5 mm, 10 mm, or 15
mm. It will be understood and appreciated by those skilled in the art that the lengths and
sizes of the cellular sampling tools correspond to the ve lengths and sizes of the
ion tubes used in the present invention. It will also be tood and appreciated by
those skilled in the art that all or part of the cellular sampling tool may be constructed of
any acceptable materials, such as medical grade thermoplastics and/or other polymer
materials, similar to or different from the materials used for constructing the insertion tube
or cervical aligning tool.
As ned, the movement of the cellular ng tool is dependent as
shown in several different exemplary embodiments of the ion, each intended to,
among other things, protect the patient's vaginal tissue and protect the cellular adhesion
surface from ure contact with the vaginal walls or cervix until the user has inserted
the device to the appropriate l canal depth. In some embodiments, the distal
movement of the cellular sampling tool is dependent upon prior distal movement of the
cervical ent tool to expose the os, and to protect the posterior of the sampling tool
from vaginal contamination, for m al cellular sampling. In certain
embodiments, the distal movement of the cellular sampling tool is dependent upon the
patient manually disengaging a retaining mechanism comprising a e tab on the
cellular sampling tool in selective communication with the insertion tube. In other
ments, distal movement of the cellular sampling tool is dependent upon removing a
retaining mechanism comprising a protective handle retaining cover which s the
tube, aligning tool and/or sampling tool until manually d by the user. In other
embodiments, the distal movement of the cellular sampling tool is dependent upon the
patient aging the sampling tool from a fixed position relative to the aligning tool by
moving the aligning tool into the second position within the tube, which automatically
releases a biased release pin or tab to permit movement of the sampling tool.
In other embodiments, the cellular ng tool is rotatable along the
longitudinal axis of the ted device through any portion thereof within the insertion
tube and bearing upon the al aligning tool and U-Ring shaped handle. In certain
embodiments, the cellular adhesion surface is an abrasive brush element. In n
embodiments, the distal end of the brush element has a cone-shaped distal end. In certain
embodiments, the ar adhesion surface is separable from the cellular sampling tool,
and may be replaced with a fresh cellular adhesion surface for re-use of the device. The
cellular adhesion surface can be manually connected and separated from the remainder of
the ng tool at a union by any mechanism such as disengaging a pin and slot
combination, or a threaded and/or frictional snapping engagement.
In certain embodiments, the ar sampling tool further comprises a
retaining sleeve slidably disposed upon the sampling tool between a first position for
retaining the adhesion surface by encompassing the union to prevent unintended
disengagement, and a second position for releasing the adhesion e by exposing the
union to permit disengagement.
In certain embodiments, the cellular adhesion surface on the distal end of
the cellular sampling tool is a brush element. In certain embodiments, the brush element is
cone-shaped, however, any shape that will serve to gently release cellular tissue from the
cervix and os will work. In certain embodiments the brush element is constructed from a
twisted wire pair having polymer bristles extending therefrom, as is known in the art. In
certain embodiments, the d wire pair extends distally, then makes a 360° loop before
returning proximally to maximize the density of bristles on the distal end. The density of
bristles on the distal end of the brush can be 2-3 times, or more, greater than the density of
es in the more proximal portion. The brush element acts to gently exfoliate and
adhere cervical cells thereto. An off-axis ation of the brush t can bias the
brush toward the cervix with the cellular sampling tool oriented with the advancing
handle. The cellular ng tool can have a length which is sufficient to extend to the
cervix of the vagina, and is actuatable by the user from outside the l canal to contact
the cervix preferably at the os to collect a cellular specimen. Cellular specimens are
typically collected by rotating the brush element at or within the os 1 to 5 times in one
direction, and then rotating the brush element at or within the os 1 to 5 times in the other
direction, or any combination of the above. Cellular exfoliating motion can also be
imparted by gently inserting and withdrawing the brush element back and forth several
times before, during or after rotation.
Brush bristles of the cellular adhesion surface are preferably made from
common, synthetic polymer fibers, cing the following desired/relevant
characteristics: cost effectiveness, good balance between flexibility for form-fitting in and
around unique contours and ty for te surface friction, ability to create micro-
abrasive/scaly surface texture for more effective specimen dislodging/exfoliation/removal,
and trapping/retention of cellular s thereon. The following cellular adhesion e
parameters can also be adjusted: round vs. rectangular vs. diamond-shaped vs. hexagonal
bristle cross-section; rounded vs. blunt vs. pointed bristle tip; embossed vs. feathered vs.
coated bristle shaft; wavy (for bushier brush head) vs. straight e shaft. Material
examples include: Nylon, Polyethylene, opylene, and DuPont's HEROX® and
TYNEX® .
When used in construction the brush wire can be made from
medical/surgical-grade polymer or stainless steel; specifically, chosen from the austenitic
steel family, for example, Type 302 or 304 stainless steel. The brush wire can be, for
example, in a twisted-wire, closed loop configuration, so as not to expose any rough-cut
ends or a blunt point, which could cause sensitive tissue , and attendant pain,
bruising, bleeding, or infection. The closed loop may present a rounded and benign tip
which simply and atraumatically collapses into itself, if inadvertently pushed too hard
against the anatomy. Optimization variables include: wire gauge and chemical treatments
for strength, flexibility, and durability; single ingle spiral vs. double stem/single
spiral vs. double stem/double spiral configurations to control bushiness and flexibility; and
spirals per inch also to control bushiness or bristle density.
In certain embodiments, the cervical aligning probe is spoon-shaped having
a smooth edged convex ure concentric with the distal end of the insertion tube. The
probe can be any shape to engage the posterior al fornix to align and distend the
cervix t puncturing or scratching the tissue. In other ments, the cervical
aligning tool further comprises an aligning extension element ing along a portion of
the body which engages an elongated alignment groove extending from the or
surface of the ion tube. The alignment system can alternatively be any configuration
of articulating surfaces which prevents the aligning tool from rotating within the insertion
tube to avoid misdirecting the aligning probe upon advancement from the insertion tube.
In certain embodiments the elongated alignment groove comprises a shallower portion
near the proximal end to alert the user when the aligning tool is within that region by
friction with the extension element, analogous to a "speed bump" to t unintentional
removal of the cervical aligning tool from the insertion tube.
In certain embodiments, the U-Ring of the cervical aligning tool engages
the proximal portion of the passage of the insertion tube as a stop point to impede further
distal movement of the cervical aligning tool within the vagina. In n embodiments,
the ing handle of the cellular sampling tool engages the proximal portion of the U-
Ring of the cervical aligning tool as a stop point to impede further distal movement of
cellular sampling tool within the vagina.
In certain embodiments, the proximal end of the insertion tube further
comprises an annular insertion shield peripherally extending from the exterior surface to
impede ion within the vagina beyond a predetermined depth. In certain
embodiments, the annular insertion shield extends in a generally triangular shape, being
wider along a e corresponding to the anterior of the vaginal opening and narrower
along an opposite surface corresponding to the ior of the l opening to guide
the patient as to the proper orientation for insertion. In certain embodiments, the proximal
end of the insertion tube further comprises a plurality of or ribbed gripping surfaces
for the user to hold the tube proximal to the insertion shield. In certain embodiments, the
proximal end of the insertion tube has a diameter r than the distal end of the
insertion tube for ease of insertion.
In certain embodiments, the device of the present ion r
comprises a sampling tool e mechanism sing a handle retaining cover having
a proximal end, a distal end, and comprising at least one insertion tube engaging surface,
at least one cervical aligning tool engaging surface, and at least one cellular sampling tool
engaging surface, wherein the handle retaining cover is removably engageable onto the
device such that movement of the cervical aligning tool and the cellular sampling tool
relative to one another, and/or relative to the ion tube, is impeded until the handle
ing cover has been removed.
The present invention further provides a method of collecting a cervical
and/or vaginal tissue sample from a patient using the device of the present invention. The
method comprises the steps of (a) ing into the vagina of the patient a device of the
present invention; (b) disengaging a handle retaining mechanism to permit distal
movement of the cervical aligning tool and the cellular sampling tool, (c) advancing the
handle of the cervical aligning tool distally from within the insertion tube in the first
position to the second position for cervical cap alignment to engage the cervical fornix of
the patient; (d) moving the elongated cellular sampling tool distally from the first position
to the second position for al cell tissue sampling; (e) rotating the ar sampling
tool to capture cervical tissue at the patient's os on the cellular adhesion surface; (f)
moving the elongated cellular sampling tool proximally from the second on to the
first position to shield the cervical tissue sample within the insertion tube; and (g)
withdrawing the device from the vagina of the patient. In certain embodiments, the
inventive method r comprises the later steps of separating the cellular adhesion
surface from the cellular sampling tool; and placing the cellular adhesion surface in a
container of cellular preservative. In n embodiments, the method provides for
performing step (c) prior to step (b), where the handle retaining mechanism ts distal
nt of only the cellular sampling tool until it is disengaged.
Therefore, in certain embodiments the inventive method comprises a step
of selectively actuating the device for dependent deployment of the cervical cap alignment
sampling tool or cervical sampling tool, by engaging or disengaging a handle retaining
mechanism. In various embodiments, the handle retaining mechanism is disengaged by
removing a handle retaining cover element, or depressing a release button when present,
before advancing the sampling tool. In certain embodiments, movement of the cervical
alignment tool into the distal position will automatically trigger a release mechanism, such
as a biased pin, to permit the sampling tool to move distally.
In n embodiments, cellular specimens are collected by rotating the
cellular sampling tool at or within the os 1 to 5 times, or 2 to 3 times, in one ion, and
then rotating the cellular ng tool at or within the os 1 to 5 times, or 2 to 3 times, in
the other direction, or any ation of the above. Cellular exfoliating motion can also
be imparted by gently inserting and withdrawing the cellular ng tool back and forth
several times before, during or after rotation.
The t invention further es a kit for cervical cell tissue ng
comprising the device of the present invention, a resealable container of cellular
preservative shaped to receive the cellular sampling tool cellular adhesion surface or
cellular sample therein, and instructions for use of the device to obtain a tissue sample and
preserve the sample in the container. In certain embodiments, the kit further comprises a
plurality of replacement cellular adhesion surfaces; and a plurality of containers of cellular
collection media.
The tion media is biologic preservative selected based on the d
sample testing to be performed. The collection media is suitable for preserving and
transporting human tissue cells and related tissue secretions, for e,
PRESERVCYT® from Cytyc Corporation (Foxboro, Mass.), SUREPATH® Perservative
Solution from TriPath Imaging Inc. (Burlington, N.C.), and CYTORICH® from Thermo
Scientific division of Thermo Fisher Scientific, Inc. (Waltham, Mass.). To test for highrisk
human Papillomavirus (HPV), chlamydia (CT) and gonorrhea (GC), the collection
medium can be the RAPID CAPTURE® System specimen transport medium (STM) from
Digene Corporation (Gaithersburg, Md.).
Therefore, the t ion provides a vaginal cervical cell tissue self-
sampling device and method of self-administration for collecting cervical tissue cells for
medical testing, such as for Pap smear or cervical cancer ing. The device primarily
comprises an insertion tube, within which is carried a movable cervical aligning tool with
an aligning probe (e.g. , aligning spoon) on its distal end, and a separately movable cellular
sampling tool with a cellular adhesion surface (e.g. , a nested brush tool) on its distal end.
The brush tool of the cellular adhesion e can be ently movable forward along
the aligning tool by the user. In one embodiment, the cellular sampling tool is movable
relative to the aligning tool dependent upon election by the user to selectively disengage a
ing mechanism. In one ment, the aligning spoon must first have been
extended to the predetermined length through the insertion tube to automatically disengage
a biased pin retaining the cellular sampling tool for movement by the user. In one
embodiment, the cellular sampling tool must first have been selectively released from
engagement with a retaining cover for movement by the user. In another embodiment, the
aligning tool must first have been selectively released from engagement with a retaining
cover for movement by the user.
Referring generally to FIGS. 1-5 of the drawings according to various
embodiments of the present invention, the cervical and/or vaginal tissue self-sampling
device (10) generally es an elongated insertion tube (20), an elongated cervical
ng tool (40) with a U-shaped handle ng") (46) attached to its proximal end
(42), and an elongated ar sampling tool (60) with a cellular on surface (68)
attached to its distal end (64), with an advancing handle (66) ed to its proximal end
(66).
The elongated insertion tube (20) is shaped for insertion into the vagina of
the patient, and has a proximal end (22), a distal end (24), an exterior surface and an
interior surface extending therethrough defining a passage, where the body of the
elongated aligning tool (40) with the advancing U-Ring (46) is placed. In certain
ments, the proximal end (22) of the insertion tube (20) further ses an
annular insertion shield (23) erally extending from the exterior surface to impede
insertion of the device (10) within the vagina beyond a predetermined depth (See FIGS.
1A and IB, FIGS. 2A and 2B). The annular insertion shield (23) is shown as triangular in
shape extending wider along a surface corresponding to the anterior of the vaginal opening
and narrower along an opposite surface corresponding to the posterior of the vaginal
opening to guide the patient as to the proper orientation for insertion (See FIGS. 1A and
1B, FIGS. 2A and 2B). In n embodiments, the proximal end (22) of the insertion
tube (20) further comprises a plurality of exterior ribbed gripping surfaces (25) proximal
to the insertion shield (23) (See FIGS. 1A and IB, FIGS. 2A and 2B). In certain
embodiments, the proximal end (22) of the insertion tube (20) has a diameter greater than
the distal end (24) of the insertion tube (20).
According to one embodiment of the present invention, the elongated
cervical aligning tool (40) has a proximal end (42) with a U-Ring (46) thereon, a distal end
(44) with a cervical aligning probe (48) thereon, and a body (50) therebetween, wherein
the U-Ring (46) is disposed outside the proximal passage of the insertion tube (20) and is
movable n a first position for insertion wherein the distal cervical aligning probe
(48) is contained within the passage of the insertion tube (20), and a second position for
cervical cap alignment wherein the distal cervical aligning probe (48) extends distally
from the passage of the insertion tube (20) to engage the al fornix of the patient (See
FIGS. 2A, 2B, 3B and 3C).
In certain embodiments, the cervical aligning probe (48) is spoon-shaped
having a convex curvature concentric with the distal end of the insertion tube (20) (See
FIGS. 2A and 3C). It will be understood and appreciated by those skilled in the art that
the al aligning probe can be in any other shapes ng sharp corners or points. In
other embodiments, the cervical aligning tool (40) further comprises an aligning extension
element (94) extending along a portion of the body which engages an elongated alignment
groove (92) ing from the interior surface of the insertion tube (20) (See FIGS 2A
and 2B). The U-Ring (46) of the cervical ng tool (40) engages the proximal portion
of the e (30) of the insertion tube (20) to impede further distal movement of the
cervical aligning tool (40) within the vagina to a pre-determined depth.
The cervical self-sampling device further comprises a cellular ng
tool (60) having a proximal end (62) with a ball-shaped advancing handle (66) thereon, a
distal end (64) with a cellular on surface (68) n, wherein the advancing handle
(66) extends from the al e of the insertion tube (20) proximal to the U-Ring
(46) of the aligning tool (40), and is dependently movable between a first position for
ion wherein the distal cellular adhesion surface (68) is contained within the passage
of the insertion tube (20), and a second position for cervical cell tissue sampling wherein
the distal cellular adhesion surface (68) extends distally from the passage of the insertion
tube (20) (See FIGS 2A, 2B, 3B, and 3C).
In the ment shown in FIGS. 4A-4D, the distal movement of the
cellular sampling tool (60) is dependent upon the patient disengaging a ing
mechanism comprising a release tab (69) on the ar sampling tool (60) in selective
communication with the insertion tube (20). The release tab (69) shown is a flexibly
resilient flange of r al that can be sed by the user to disengage away
from the insertion tube (20) ng point, however, a wide variety of alternatively biased
or spring-loaded manual release mechanisms will be apparent to one of skill in view of the
present disclosure. In other embodiments, not shown in the figures, the distal movement
of the cellular sampling tool is dependent upon the patient selectively moving the aligning
tool into the second position, for example, whereby the retaining mechanism comprising
indentations on the interior surface of the tube which can engage one or more biased pins
g the alignment tool and sampling tool in a fixed relative position to automatically
release when the alignment tool is distally inserted into the tube in the second position.
In addition to being movable in a distal direction for al cell tissue
sampling, the cellular sampling tool (60) is rotatable within the insertion tube (20) and
upon the cervical aligning tool (40) and U-Ring (46) cellular tissue can be retained on the
bristles of the cellular adhesion surface (68) of the sampling tool (60) by rotating it several
times against the os of the cervix. According to one embodiment of the present invention,
the advancing handle (66) of the cellular sampling tool (60) engages the proximal portion
of the U-Ring (46) of the cervical aligning tool (40) to impede further distal movement of
cellular ng tool (60) within the vagina.
In manufacturing assembly of the device, the cellular sampling tool (60) is
placed upon the cervical aligning tool (40) with the advancing handle (66) extending
proximal to the U-Ring (46) of the ng tool (40). The combined cellular sampling
tool (60) along with the cervical aligning tool (40) are placed inside the passage of the
insertion tube (20). The handle (66) of the cellular sampling tool (60) along with the U-
Ring (46) of the cervical aligning tool (40) are placed outside and proximal to the
proximal end (22) of the insertion tube (20), where they are secured to the tube (20) by a
handle retaining cover (70). The handle retaining cover (70) is intended to remain in place
before and during insertion into the patient's vagina, and to be removed before the cervical
aligning tool and cellular ng tool are extended (See FIGS 3A, 4A, and 5A showing
the ion position where the handle retaining cover is on, and FIGS 3B, 4B, 5B, and
5C g the handle retaining cover off). However, the retaining cover (70) can also be
removed before insertion of the tube, or after distal movement of the aligning tool. In
either case, distal movement of at least the ar sampling tool (60) is dependent upon
prior user removal of the retaining cover (70).
FIGS 2B, 3A, 4A, and 5C show that in one embodiment, the device
comprises a handle retaining mechanism comprising a handle retaining cover (70) having
a proximal end (72), a distal end (74), and comprising an insertion tube engaging surface
(75), cervical aligning tool engaging surfaces (77), and a cellular sampling tool engaging
surfaces (79), (80), wherein the handle retaining cover (70) is removably engageable with
the device (10) such that movement of the al aligning tool (40) and the cellular
sampling tool (60) is impeded until the retaining cover (70) is lifted off the device (10) by
the user. The sampling tool handle (66) has retaining cover engagement surfaces (65),
(67) corresponding to the cellular sampling tool engaging surfaces (79), (80), respectively.
The aligning tool has further engagement surfaces (49) on the top of the U-Ring. The
ion tube (20) has retaining tube ment es (28). In some embodiments,
the al aligning tool (40) can move forward along these engagement surfaces (49),
while the retaining cover is engaged, preventing the cellular sampling tool (60) from
moving. The ing cover is maintained in place by frictional t between the
elements due to sized tensioning, or flexibly biased ning, of the various engaging
surfaces configured as desired to be retained. In particular, the proximal sampling tool
handle engaging surface (80) indentation can provide the frictional contact tension of a
magnitude to prevent the cover from falling off on its own, but to be readily removed by a
single-handed action, and to be snapped back in to place when desired.
In certain embodiments such as those shown, the cellular on surface
(68) is separable from the ar sampling tool (60) (See FIGS. 2A and 2B). In certain
embodiments, the cellular sampling tool (60) further comprises a retaining element (80)
disposed upon the sampling tool (60) between a first position for retaining the adhesion
surface (68) and a second position for releasing the adhesion surface (68) (See FIGS. 2A
and 2B). In certain embodiments, the retaining element is a threaded member that engages
threads on the proximal end of the cellular adhesion surface. The ion thereby
provides that the cervical tissue sample on the adhesion surface can be disengaged from
the rest of the device for e and ortation of the cellular sample to a laboratory
for testing and analysis. In some embodiments, the cellular sample may be removed from
the adhesion surface by rinsing in a cellular preservative solution, and in other
embodiments, the entire adhesion surface can be stored with the cellular sample thereon
within a ner of cellular preservative on. The invention also thereby provides
for re-use of the main device with replacement on surfaces, which can be provided
in a kit or made available for individual purchase.
The present invention also provides methods of collecting a cervical tissue
sample from a patient using the device of the present invention. The inventive method
comprises the steps of (a) inserting into the vagina of the patient a device (10) of the
present invention as shown in or 4A; (b) advancing the U-Ring (46) of the
al aligning tool (40) distally from within the insertion tube (20) in the first position
to the second position for cervical cap ent to engage the posterior cervical fornix of
the patient as shown in ; (c) removing the handle retaining cover as shown in , (d) moving the ted cellular sampling tool (60) distally from the first position to
the second position for cervical cell tissue sampling as shown in ; (e) rotating the
cellular sampling tool (40) several times in each direction at and within the patient's os,
and/or gently inserting and withdrawing the tool in the os, to capture cervical tissue on the
cellular adhesion surface (68); (f) moving the elongated cellular sampling tool (60) and
optionally the cervical cap alignment tool (40) proximally from the second position to the
first position to shield the cervical tissue sample within the ion tube (20); and (g)
withdrawing the device (10) from the vagina of the patient.
In certain other s, the insertion tube (20) is inserted into the vagina
with the cervical aligning probe (48) (e.g., spoon) and cellular sampling adhesion surface
(68) (e.g. , brush element) fully retracted within the insertion tube (20) and secured in place
with the handle retaining cover (70). When the insertion tube (20) has been inserted to the
depth of the cervix, the handle retaining cover is removed. The cervical aligning probe
(48) is then moved forward outside the distal end (24) of the insertion tube (20) and
against the posterior fornix of the cervix, which ds the posterior side of the cervix
away and exposes the cervical opening (the os) for the brush tip of the sampling adhesion
surface (68) still inside the tube (See ). As shown in the embodiment of ,
with the end of the aligning probe (48) fully extended outside the tube (20), the cellular
sampling tool (40) can be released by the user depressing a release tab (69), to be
ed outside the distal end (24) of the insertion tube (20) over the aligning probe (48).
Thus, the insertion tube (20) and aligning probe (48) have oned the brush tip of the
sampling adhesion surface (68) at or within the os, whereby endocervical cells of interest
can be captured n by rotation and/or gentle plunging of the sampling tool (60).
After the specimens are collected, the sampling adhesion surface (68) and
aligning probe (48) are withdrawn back into the protective tubing (20), and then the entire
device (10) is withdrawn from the vaginal canal. The adhesion surface (68) with the
cellular sample thereon can then be dipped into a container of cellular preservative and
agitated to release the sample for shipping and further laboratory analysis. In other
embodiments, the ar adhesion surface (68) can be separated from the ar
sampling tool (60), such as by rotating the ar adhesion surface (68) which can be
placed entirely in a container of cellular preservative for shipping and further laboratory
analysis. The device (10) can be cleaned and re-used.
The inventive device is intended to be provided in a kit with the insertion
tube, cervical aligning tool, and ar sampling tool assembled, as illustrated. The kit
for cervical cell tissue sampling ses the device of the present invention, a
pharmaceutically acceptable vaginal lubricant, one or more resealable containers of
cellular preservative shaped to receive the cellular adhesion surface therein, and
instructions for use of the device to obtain a tissue sample and preserve the sample in the
container for ng and further laboratory analysis. In certain embodiments, the kit
further comprises a plurality of replacement cellular adhesion surfaces and a plurality of
ners of cellular preservative. After the user has collected the cervical tissue sample
and placed it in the container of cellular preservative, the container is sent (such as by mail
or r) to a laboratory for analysis of the sample.
gh the invention has been described with a certain degree of
particularity, it is understood and appreciated by those d in the art that the present
disclosure has been made only by way of example. The device and the method of use
thereof, of the t invention may be changed or modified using alternative
mechanisms and materials known in the art without departing from the spirit and scope of
the invention. Thus, the scope of the ion should not be limited by the foregoing
specification, but rather, only defined in the following claims.
Claims (17)
- A device for collecting a cervical tissue sample from a patient comprising: (a) an elongated ion tube shaped for insertion into the vagina of the patient and having a proximal end, a distal end, an exterior surface and an interior surface extending therethrough defining a passage; (b) an elongated cervical aligning tool shaped for insertion within the passage of the insertion tube and having a al end with a handle thereon, a distal end with a cervical ng probe thereon and a body therebetween, wherein the aligning tool handle is disposed e the proximal passage of the insertion tube and is movable between a first position for insertion wherein the distal cervical aligning probe is ned within the passage of the insertion tube, and a second on for cervical cap alignment wherein the distal al aligning probe extends distally from the passage of the insertion tube to engage the al fornix of the patient; and (c) an elongated cellular ng tool shaped for ion within the passage of the insertion tube and upon a portion of the body of the elongated aligning tool and within the advancing ng tool handle, and having a proximal end with an advancing handle n, a distal end with a cellular adhesion surface thereon, wherein the advancing handle extends from the al passage of the insertion tube proximal to the aligning tool handle, and is releasably movable between a first position for insertion wherein the distal cellular adhesion surface is contained within the passage of the insertion tube, and a second position for cervical cell tissue sampling wherein the distal cellular adhesion surface extends distally from the passage of the insertion tube.
- The device of Claim 1, wherein distal movement of the cellular sampling tool is released by a retaining mechanism comprising a handle retaining cover comprising a proximal end, a distal end, an insertion tube engaging surface, a cervical aligning tool engaging surface, and a cellular sampling tool engaging surface, wherein the handle retaining cover is removably disengageable with the device such that distal nt of the cervical aligning tool and the cellular ng tool is impeded when the retaining cover is engaged, and distal movement is permitted when the retaining cover is removed.
- 3. The device of Claim 1, wherein distal movement of the cellular sampling tool is released by a retaining mechanism sing a manual release tab on the sampling tool in disengaging communication with the insertion tube, wherein distal movement of the cellular sampling tool is impeded when the pin is engaged when the sampling tool is in the first position, and distal movement is permitted when the tab is manually disengaged.
- 4. The device of Claim 1, wherein distal movement of the cellular sampling tool is released by a retaining mechanism comprising a biased release pin on the sampling tool in selective ication with the insertion tube, wherein distal movement of the cellular sampling tool is impeded by the pin in communication with the ion tube when the alignment tool and sampling tool are in the first position, and distal movement of the cellular sampling tool is permitted when the alignment tool is in the second position automatically releasing the biased pin from ication with the insertion tube.
- 5. The device of Claim 1, wherein the cellular ng tool is rotatable within the insertion tube and upon the cervical aligning tool handle.
- 6. The device of Claim 1, wherein the distal end of cellular adhesion surface is an ve brush element with a looped wire with bristle uration.
- 7. The device of Claim 1, wherein the cellular adhesion surface is separable from the cellular sampling tool.
- 8. The device of Claim 1, where the cellular ng tool further comprises a retaining element disposed upon the sampling tool between a first position for retaining the adhesion surface and a second position for releasing the adhesion surface.
- 9. The device of Claim 1, wherein the cervical aligning probe is spoon-shaped having a convex curvature concentric with the distal end of the insertion tube.
- 10. The device of Claim 1, wherein the cervical aligning tool further comprises an aligning extension element extending along a portion of the body which engages an elongated alignment groove extending from the interior surface of the insertion tube.
- 11. The device of Claim 1, wherein the handle of the cervical aligning tool engages the proximal portion of the passage of the insertion tube to impede further distal movement of the cervical ng tool within the vagina.
- 12. The device of Claim 1, wherein the advancing handle of the cellular sampling tool engages the proximal portion of the handle of the cervical aligning tool to impede further distal movement of cellular sampling tool within the vagina.
- 13. The device of Claim 1, wherein the al end of the insertion tube further ses an r insertion shield peripherally extending from the exterior surface to impede insertion within the vagina beyond a predetermined depth.
- 14. The device of Claim 13, wherein the annular insertion shield extends wider along a surface corresponding to the anterior of the vaginal opening and narrower along an opposite e corresponding to the ior of the vaginal opening to guide the patient as to the proper orientation for insertion.
- 15. The device of Claim 1, wherein the proximal end of the insertion tube r comprises a plurality of exterior ribbed ng surfaces proximal to the insertion shield.
- 16. The device of Claim 1, wherein the al end of the insertion tube has a er greater than the distal end of the insertion tube.
- 17. A kit for cervical cell tissue sampling comprising the device of Claim 1, one or more replacement cellular adhesion surfaces; one or more containers of cellular preservative, and instructions for use of the device to obtain a cervical cellular tissue sample and preserve the sample in the container.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201161532724P | 2011-09-09 | 2011-09-09 | |
US61/532,724 | 2011-09-09 | ||
PCT/US2012/053355 WO2013036447A1 (en) | 2011-09-09 | 2012-08-31 | Cervical cell tissue self-sampling device |
Publications (2)
Publication Number | Publication Date |
---|---|
NZ621851A NZ621851A (en) | 2015-09-25 |
NZ621851B2 true NZ621851B2 (en) | 2016-01-06 |
Family
ID=
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