U.S. patent application number 11/314754 was filed with the patent office on 2007-06-21 for cell collection device.
Invention is credited to Steven A. Scampini.
Application Number | 20070142746 11/314754 |
Document ID | / |
Family ID | 38189055 |
Filed Date | 2007-06-21 |
United States Patent
Application |
20070142746 |
Kind Code |
A1 |
Scampini; Steven A. |
June 21, 2007 |
Cell collection device
Abstract
This invention relates generally to medical devices, and more
particularly, an apparatus and method for collecting cells or
tissue samples from the cervix of a patient for medical
testing.
Inventors: |
Scampini; Steven A.;
(Groton, MA) |
Correspondence
Address: |
Theodore Allen, Esq;Cytyc Corporation
250 Campus Drive
Marlborough
MA
01752
US
|
Family ID: |
38189055 |
Appl. No.: |
11/314754 |
Filed: |
December 21, 2005 |
Current U.S.
Class: |
600/572 ;
600/570 |
Current CPC
Class: |
A61B 2010/0074 20130101;
A61B 10/0045 20130101; A61B 10/0291 20130101 |
Class at
Publication: |
600/572 ;
600/570 |
International
Class: |
A61B 10/00 20060101
A61B010/00 |
Claims
1. A device for the collecting cells and other biological
materials, comprising: a substantially porous distal end portion
configured for collecting cells comprising; a proximal end portion
having an actuator coupled thereto; and an elongated middle portion
having a lumen in fluid connection with said distal and proximal
end portions and extending therethrough.
2. The device according to claim 1, wherein said actuator comprises
an elastomeric retention bulb.
3. The device according to claim 1, wherein said cells are
ectocervical cells.
4. The device according to claim 1, wherein said substantially
porous tip is comprised of an open cell foam material.
5. The device according to claim 1, wherein said distal and
proximal end portions are integrally molded with said elongated
middle portion.
6. A method for collecting cells and other biological materials,
comprising: inserting a collection device into a patient's vagina
wherein the collection device is comprised of: a substantially
porous distal end portion configured for collecting cells; a
proximal end portion having a pump coupled thereto; and an
elongated middle portion having a lumen in fluid connection with
said distal and proximal end portions and extending therethrough;
wiping the patient's cervix with the substantially porous distal
end of the collection device to collect a biological sample;
removing the collection device from the patient's vagina; inserting
the substantially porous distal end of the collection device into a
specimen vial containing collection fluid; drawing fluid into the
lumen of the collection device through the substantially porous
distal tip by creating negative pressure in the lumen by an
actuator; and expelling the fluid back through the lumen and out of
the substantially porous distal end by releasing the negative
pressure; wherein expelling the fluid back through the lumen and
out of the substantially porous distal tip releases the collected
cells from the porous distal tip and into the collection fluid.
7. The method according to claim 6, wherein said actuator comprises
an elastomeric retention bulb.
8. The method according to claim 6, wherein said biological sample
comprises ectocervical cells.
9. The method according to claim 6, wherein said substantially
porous tip is comprised of an open cell foam material.
10. The method according to claim 6, wherein said distal and
proximal end portions are integrally molded with said elongated
middle portion.
Description
FIELD OF THE INVENTION
[0001] This invention relates generally to medical devices, and
more particularly, an apparatus and method for collecting cells or
tissue samples from the cervix of a patient for medical
testing.
BACKGROUND OF THE INVENTION
[0002] Cancer is responsible for significant health problems in
populations of women in the United States and throughout the world.
In particular, gynecological cancers, including ovarian, uterine,
cervical, and vuvlar cancers, are responsible for over 5,000 deaths
in the United States each year. Although recent years have seen
advances in detection and treatment of these cancers, mortality
rates remain significantly high.
[0003] Cervical cancer can be prevented and possibly cured if
detected early enough in its precancerous or precursor stages.
There are a variety of known techniques for the early detection of
cervical cancer. Most of these techniques include the scraping or
sampling of tissue from the uterine or endocervical canal using a
spatula or brush collection device. Tissues or cells obtained with
these devices would be subjected to cytological or other
examinations, such as the Papanicolaou or Pap smear.
[0004] The present invention relates to an improved cell collection
device and method for obtaining tissue samples from the uterus of a
patient. A number of devices have been developed to collect samples
from the cervix including cotton swabs introduced into the uterine
canal, wet spatulas, wooden spatulas, aspiration through plastic or
glass pipettes, and endocervical sample collection brushes.
Examples of such devices are disclosed in U.S. patents to MacLean
(U.S. Pat. No. 2,955,591), Antonides (U.S. Pat. No. 3,626,470),
Oster (U.S. Pat. No. 3,815,580), Vermes (U.S. Pat. No. 3,877,464),
Levene (U.S. Pat. No. 3,881,464), Milan (U.S. Pat. No. 3,945,372),
Nollan (U.S. Pat. No. 4,127,113), White (U.S. Pat. No. 4,175,008),
Kist (U.S. Pat. No. 4,700,713), Bayne (U.S. Pat. No. 4,754,764),
Bayne et al (U.S. Pat. No. 4,762,133), Bayne (U.S. Pat. Nos.
4,754,764 and 4,873,992), Bucaro (U.S. Pat. No. 4,862,899), Samuels
(U.S. Pat. No. 4,953,560), Worthen et al. (U.S. Pat. No.
5,445,164), Sak (U.S. Pat. No. 5,787,891), Leet et al. (U.S. Pat.
No. 5,795,309), and Wallach (U.S. Pat. Nos. 6,387,058 and
6,740,049)
[0005] Although cell collection brushes are well known and widely
used, there are many disadvantages associated with the present cell
collection brushes. One disadvantage is the dispersal of the
collected biological material from the cell collection brushes into
a sample vial. During use, a collection brush is inserted inside
the vagina and is then rotated one or more full turns to scrape off
tissue material from the opening of the endocervical canal. After
the cell sample is collected, the collection brush is either
swirled in a specimen vial containing cell preservative to release
cells from the brush or a portion of the brush is detached into a
specimen collection vial for transportation to a laboratory for
processing.
[0006] A disadvantage associated with this type of brush assembly
is that a number of cells remain attached to the collection brush
even after the brush is agitated in solution. Since it is important
to obtain a large enough sample of cells to ensure the chances of
detecting abnormal cells in a sample, it would therefore be highly
desirable to have a device which increases the total number of
exocervical and endocervical cells collected from a patient.
SUMMARY OF THE INVENTION
[0007] The invention generally relates to medical devices, and more
particularly, to medical devices and method for collecting cells or
tissue samples from the uterus of a patient for medical testing. In
one aspect of the present invention, a device for the collecting
cells and other biological materials is presented. The medical
device is comprised of a distal end portion for collecting cells,
such distal end comprising a substantially porous tip; a proximal
end portion comprising a pump; and an elongated middle portion
comprising a lumen in fluid connection with the distal and proximal
end portions and extending therethrough.
[0008] In another aspect of the invention, a medical device for
collection biological material from a patient is provided. The
medical device is comprised of a distal end portion for collecting
cells, such distal end comprising a substantially porous tip; a
proximal end portion comprising a pump; and an elongated middle
portion comprising a lumen in fluid connection with the distal and
proximal end portions and extending therethrough. The elongated
middle portion of the medical device also contains at least one
valve to prevent the uptake of fluid through the substantially
porous tip and into the internal lumen of the elongated middle
portion of the device.
[0009] In yet another aspect of the present invention, a method for
collecting cells and other biological materials is presented. The
method of collecting cells comprises collecting cells or other
biological material using a device comprising a distal end portion
for collecting cells with a substantially porous tip; a proximal
end portion comprising a pump; and an elongated middle portion
comprising a lumen in fluid connection with the distal and proximal
end portions and extending therethrough, by drawing fluid into the
lumen through the porous tip by creating negative pressure in the
lumen by the pump; and expelling the fluid back through the lumen
and out the porous distal tip by releasing the negative pressure.
The expelling of the fluid back through the lumen and out the
porous distal tip releases the collected cells from said the
tip.
BRIEF DESCRIPTION OF THE DRAWING
[0010] FIG. 1 is a side view of a first preferred embodiment of the
present invention.
[0011] FIG. 2 is a side view of a second preferred embodiment of
the present invention.
DETAILED DESCRIPTION
[0012] It is contemplated that embodiments of the present invention
may be utilized for the collection of cells or tissue samples from
the body of a patient for medical testing. However, collection of
cells or tissue samples from the uterus of a patient will be
discussed below in an exemplary manner.
[0013] In one aspect of the present invention, a device for
collecting cells and other biological materials is presented. The
medical device is comprised of a distal end portion for collecting
cells, such distal end comprising a substantially porous tip; a
proximal end portion comprising a pump; and an elongated middle
portion comprising a lumen in fluid connection with the distal and
proximal end portions and extending therethrough.
[0014] According to a preferred embodiment, the substantially
porous tip is comprised of an open cell flexible material such as
foam or sponge. The foam may be comprised of polyolefin, urethane,
polyurethane, or silicone materials. In a preferred embodiment of
the present invention, the substantially porous tip is comprised of
open cell foam.
[0015] The proximal end of the medical device includes an actuator
for creating negative pressure at the distal tip thus drawing fluid
through the substantially porous distal tip and into the lumen
within the elongated middle portion of the device which is in fluid
connection between the proximal and distal end portions of the
device. In one embodiment of the present invention, the actuator
for drawing a fluid through the substantially porous distal tip and
into the lumen within the elongated middle portion of the device is
a pump. In another embodiment of the present invention, the pump is
an elastomeric retention bulb or a squeezable bladder.
[0016] The elongated portion of the present invention may be
composed of glass or plastic. In one embodiment of the present
invention, the medical device is composed plastic. Examples of
plastics that may be used in the construction of the device
include, for example, polypropylene, polystyrene,
acrylonitrile-butadiene-styrene copolymer (ABS resin),
polyethylene, polyvinyl chloride, polycarbonate, polyamide, and
polyester.
[0017] In another embodiment of the present invention, a device for
the collecting cells and other biological materials is presented.
The collection device is comprised of a substantially porous distal
end portion configured for collecting cells having a proximal end
portion with an actuator coupled thereto; an elongated middle
portion having a lumen in fluid connection with the distal and
proximal end portions and extending therethrough.
[0018] Referring first to FIG. 1 of the drawings, the collection
device of the invention [10] includes a distal end portion [20] for
collecting cells; a proximal end portion [30] including a pump
[70]; and an elongated middle portion [40] comprising a lumen [60]
in fluid contact with the proximal and distal end portions.
[0019] The distal end portion [20] of the collection device [10]
has a substantially porous tip [14]. The proximal end portion [30]
of the collection device [10] has a pump [70] for drawing fluid
into the lumen [60] of the elongated middle portion [40] of the
collection device. The proximal end portion [30] may be comprised
of a flexible, squeezable bladder that is a separate assembly or
molded as an integral part of the collection device.
[0020] The elongated middle portion [40] is comprised of a lumen
[60] that is in fluid contact with both the proximal and distal end
portions of the collection device. The lumen [60] has a bore of a
sufficient diameter to allow unimpeded flow of fluid from the
distal end portion [20] to the proximal end portion [30] of the
collection device [10]. The elongated middle portion [40] has
sufficient tensile strength to serve as a handle for the collection
of biological material from a patient. The distal end of the
elongated middle portion [40] of the collection device [10] may
contain perforations which would allow the flow of fluid through
the open cell foam tip [50] and into the lumen [60]. The size of
the perforations is sufficient to prevent cells from entering the
lumen of the collection device.
[0021] With the pump [70] in an uncompressed condition as shown in
FIG. 1, the distal end portion [20] of the collection device [10]
is inserted into the vagina of a patient (not shown). Insertion of
the collection device [10] continues until the distal end portion
[20] of the device contacts the cervix. Once the distal end portion
[20] contacts the cervix, a specimen sample is obtained by swabbing
the cervix with the open cell foam tip [50] of the collection
device. Cells and other biological materials are captured on and
within the open cell foam tip of the collection device. Once a
specimen sample has been obtained, the collection device [10] is
removed from the patient and the distal end portion [20] is placed
into a specimen collection vial (nor shown) which contains a cell
preservative solution. Rather than merely agitating the collection
device in the preservative solution or depositing the collection
portion of the device into fluid as is the current practice, the
flexible squeezable bladder [70] or other similar pump may be
activated, thus creating positive pressure which forces air through
the lumen [60] of the elongated middle portion [40] of the
collection device. When the flexible squeezable bladder [70] is
released, negative pressure is created within the bladder which in
turn draws fluid from the specimen collection vial through the
porous open cell foam tip [50] and into the lumen [70] of the
collection device. Subsequent activation of the pump [70] creates
positive pressure which results in the expulsion of the fluid from
lumen [70] through the porous open cell foam tip [50] and back into
the specimen collection vial. The process may be repeated (several
squeeze/release cycles). The movement of fluid through the foam tip
aides in the dislodging of cells captured in and on the open pore
material and into suspension within the fluid. The suspended cells
may be used for further medical testing.
[0022] Another embodiment of the present invention, a one way valve
is built into the shaft of the collection device near the foam tip.
The valve is orientated such that when negative pressure is exerted
by the bladder (releasing compression) fluid is drawn into the
shaft. Additionally, another one-way valve is positioned within the
shaft above the tip such that when negative pressure is exerted by
the bladder (releasing compression), the valve closes thus
preventing fluid from being drawn through the porous tip and into
the lumen. When positive pressure is exerted (by compressing the
bladder), the valve closes. This allows fluid to be expelled from
the collection device and not drawn into the device through the
porous tip. The advantage of this embodiment of the invention is
that a collection device may be pre-loaded with collection or
preservative fluid before a specimen sample is collected from a
patient. By pre-loading a collection device, the step of drawing
fluid into the collection device, after a sample has been
collected, may be avoided. Thus, a practitioner pre-loads the
device, or obtains a pre-loaded collection device, by initially
drawing fluid into the lumen through the porous tip by creating
negative pressure in the lumen by the pump. The practitioner then
collects a patient sample on the porous distal tip, inserts the
distal tip into a specimen collection vial containing preservative
solution, and then expels the fluid back through the lumen and out
the porous distal tip by releasing the negative pressure. The
expelling of the fluid back through the lumen and out the porous
distal tip releases the collected cells from the tip and into
suspension within the cell preservative solution in the specimen
vial.
[0023] Referring now to FIG. 2 of the drawings, the collection
device of the invention [10] includes a distal end portion [20] for
collecting cells; a proximal end portion [30] comprising a pumping
[70]; and an elongated middle portion [40] comprising a lumen [60]
in fluid contact with the proximal and distal end portions. The
elongated middle portion [40] contains at least one valve [80A;
80B] which prevent the flow of fluid from the distal end portion
[20] to the proximal end portion [30] of the collection device
[10].
[0024] In another aspect of the present invention, a method for
collecting cells and other biological materials is presented. The
method of collecting cells comprises collecting cells or other
biological material using a device comprising a distal end portion
for collecting cells with a substantially porous tip; a proximal
end portion comprising a pump; and an elongated middle portion
comprising a lumen in fluid connection with the distal and proximal
end portions and extending therethrough, by drawing fluid into the
lumen through the porous tip by creating negative pressure in the
lumen by the pump; and expelling the fluid back through the lumen
and out the porous distal tip by releasing the negative pressure.
The expelling of the fluid back through the lumen and out the
porous distal tip releases the collected cells from said the tip
and into the collection fluid. The suspended cells may be further
processed for medical testing or visual examination such as liquid
based cytology. Examples of methods and apparatus for generating a
thin monolayer of cells on a slide advantageous for visual
examination are disclosed in U.S. Pat. No. 5,143,627 issued to
Lapidus et al. and entitled "Method and Apparatus for Preparing
Cells for Examination;" U.S. Pat. No. 5,240,606 issued to Lapidus
et al. and entitled "Apparatus for Preparing Cells for
Examination;" U.S. Pat. No. 5,269,918 issued to Lapidus et al. and
entitled "Clinical Cartridge Apparatus;" U.S. Pat. No. 5,282,978
issued to Polk, Jr. et al. and entitled "Specimen Processor Method
and Apparatus," and U.S. Pat. No. 6,572,824 issued to Ostgaard et
al. and entitled "Method and Apparatus for Preparing Cytological
Specimens;" all of which are assigned to the assignee of the
present invention and all of the disclosures of which are
incorporated herein by reference in their entirety.
[0025] In yet another aspect of the present invention, a method for
collecting cells and other biological materials is presented. The
method of collection cells comprises inserting a collection device
into a patient's vagina wherein the collection device is comprised
of a substantially porous distal end portion configured for
collecting cells; a proximal end portion having a pump coupled
thereto; and an elongated middle portion having a lumen in fluid
connection with said distal and proximal end portions and extending
therethrough. Once the collection device has been inserted into a
patient's vagina and is positioned near the patient's cervix, a
biological sample is obtained by swabbing or wiping the patient's
cervix with the substantially porous distal end of the collection
device.
[0026] Once the biological sample has been obtained, the collection
device is removed from the patient's vagina and the substantially
porous distal end of the collection device is inserted into a
specimen vial containing collection fluid such that the distal end
of the collection device is submerged in the collection fluid. The
collection fluid may consist of a cell preservative fluid or any
other fluids used for the preservation, processing, or storage of
biological samples for future medical testing or evaluation.
[0027] Once submerged, fluid from the specimen collection vial is
drawn into the lumen of the collection device through the
substantially porous distal tip by creating negative pressure in
the lumen by an actuator. The actuator may be any device that is
capable of creating positive or negative pressure within the lumen
of the collection device such as a pump. After fluid has been drawn
into the lumen, fluid is then expelled back through the lumen and
out of the substantially porous distal end by releasing the
negative pressure. The process of expelling fluid back through the
lumen and out of the substantially porous distal tip releases the
collected cells from the porous distal tip and into the collection
fluid.
[0028] In still yet another aspect of the present invention, a
method for collecting cells and other biological materials is
presented. The method of collection cells comprises using a
collection device which is comprised of a substantially porous
distal end portion configured for collecting cells; a proximal end
portion having a actuator, such as a pump, coupled thereto; at
least one, one-way valve built into the elongated portion of the
collection device near the foam tip; and an elongated middle
portion having a lumen in fluid connection with the distal and
proximal end portions and extending therethrough. An example of a
pump is an elastomeric retention bulb or bladder. The one-way valve
is orientated such that when negative pressure is exerted by the
pump (releasing compression) fluid is drawn into the lumen.
Additionally, another one-way valve is positioned within the
elongated portion of the collection device above the tip such that
when negative pressure is exerted by the pump (releasing
compression), the valve closes thus preventing fluid from being
drawn through the porous tip and into the lumen. When positive
pressure is exerted by the pump, the valve closes. This allows
fluid to be expelled from the collection device and not drawn into
the device through the porous tip.
[0029] Thus, a practitioner pre-loads the collection device, or
obtains a pre-loaded collection device, by initially drawing fluid
from the specimen collection vial into the lumen of the collection
device before collecting the patient sample. Examples of fluid
would be preservative fluids or other collection fluids. After the
collection device has been pre-loaded, the practitioner then
collects a patient sample by inserting the collection device into a
patient's vagina. Once the collection device is inserted into a
patient's vagina and is positioned near the patient's cervix, a
biological sample is obtained by swabbing or wiping the patient's
cervix with the substantially porous distal end of the collection
device.
[0030] After a biological sample has been obtained, the collection
device is removed from the patient's vagina and the substantially
porous distal end of the collection device is inserted into a
specimen vial containing collection fluid which is substantially
similar or identical to the fluid pre-loaded into the collection
device, such that the distal end of the collection device is
submerged in the collection fluid. The collection fluid may consist
of a cell preservative fluid or any other fluids used for the
preservation, processing, or storage of biological samples for
future medical testing or evaluation.
[0031] Once submerged, the collection device may be agitating in
the collection fluid to dislodge cells of other biological material
captured on or in the porous distal tip. To further dislodge any
remaining cells or other biological material that may remain in the
porous distal tip of the collection device, fluid pre-loaded into
the lumen of the device may be expelled back through the lumen and
out of the substantially porous distal end by applying positive
pressure by the actuator. The process of expelling fluid back
through the lumen and out of the substantially porous distal tip
releases any remaining collected cells from the porous distal tip
and into the collection fluid.
[0032] The invention can be embodied in other specific forms
without departing from the spirit or essential characteristics
thereof. The present embodiments are therefore to be considered in
all respects as illustrative and not restrictive. The scope of the
invention is indicated by the appended claims, rather than by the
foregoing description, and all changes which come within the
meaning and range of equivalency of the claims are therefore
intended to be embraced therein.
* * * * *