U.S. patent number 3,640,268 [Application Number 04/503,679] was granted by the patent office on 1972-02-08 for method and device for biopsy specimen collecting and handling.
Invention is credited to Hugh J. Davis.
United States Patent |
3,640,268 |
Davis |
February 8, 1972 |
**Please see images for:
( Certificate of Correction ) ** |
METHOD AND DEVICE FOR BIOPSY SPECIMEN COLLECTING AND HANDLING
Abstract
A method for procuring and processing samples of cellular
material which comprises the steps of removing from a body cavity
samples of cellular material, washing the samples of cellular
material into a fluid container and processing the samples of
cellular material directly within the container structure for
eventual analysis in the cancer detection; the apparatus for use in
carrying out the method includes a tubular member, a cap adapted to
fit over one end of the tubular member to close the same, a fluid
container adapted to be used as centrifuging container adapted to
be connected to the other end and a swab structure or the like
adapted to be removably connected with the other end of the tubular
member. The dimension of the cap and other end are thereby so
chosen that the cap can also be connected to the other end of the
tubular member so as to form a pipette structure.
Inventors: |
Davis; Hugh J. (Baltimore,
MD) |
Family
ID: |
24003072 |
Appl.
No.: |
04/503,679 |
Filed: |
October 23, 1965 |
Current U.S.
Class: |
600/572; 600/570;
604/1; 401/119; 401/130 |
Current CPC
Class: |
B01L
3/5029 (20130101); B01L 3/5021 (20130101); A61B
10/02 (20130101); B01L 3/50825 (20130101); G01N
2001/028 (20130101); B01L 2200/141 (20130101); B01L
2200/0647 (20130101); A61F 13/38 (20130101); B01L
2400/0481 (20130101); B01L 2400/049 (20130101); B01L
3/021 (20130101) |
Current International
Class: |
A61B
10/00 (20060101); A61F 13/38 (20060101); G01N
1/02 (20060101); A61b 010/00 () |
Field of
Search: |
;128/2,2B,232,218,233,304,240,276 ;23/259,292 ;118/413,414
;15/236 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
V Mueller & Co., Catalogue No. 65, Rand McNally & Co.,
1963, RD 76 M8 (p. 45 relied upon)..
|
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Howell; Kyle L.
Claims
I claim:
1. Apparatus for procuring and processing samples of cellular
material from body cavities comprising in combination a tubular
member open at both ends, a first hollow flexible closure member
having an open end, a second hollow flexible closure member having
an open end, a swab means, a first connector means detachably
assembling said first hollow closure member to one end of said
tubular member, a second connector means detachably assembling said
second hollow closure member to the other end of said tubular
member, and third connector means detachably assembling said swab
means to said one end of said tubular member to enable said swab
means to depend into said first hollow member.
2. Apparatus for procuring and processing samples of cellular
material from body cavities comprising in combination a first
hollow flexible member of a first interior volume and of a physical
strength sufficient to enable it to be used as a centrifugal
container and having an open end, a second hollow flexible member
of relatively smaller interior volume and having an open end, and a
tubular member open at both ends, first releasable connector means
detachably assembling said first hollow member to said tubular
member, second connector means detachably assembling said second
hollow member to the other end of said tubular member, a swab
means, a third releasable connector means interior of said first
releasable connector means detachably assembling said swab means to
said tubular member, and said second hollow member being of
sufficient external diameter to be detachably connected to said
third connector means to provide a pipette bulb upon disengagement
of said swab means.
3. Method of procuring and processing cellular material from a body
cavity by means of a container structure including means forming a
swab and a fluid containing structure, comprising the steps of
introducing the swab into a body cavity, withdrawing the swab from
the body cavity and introducing said swab into the containing
structure to wash the samples of cellular material from the swab
into the containing structure, processing the samples of cellular
material by centrifuging the samples within said containing
structure, and eventually distributing the thus processed cellular
material on a microscope slide directly from said container
structure.
4. Method of procuring and processing samples of cellular material
by means of a container structure including means forming a swab, a
pipette and a fluid containing structure, comprising the steps of
aspirating by the use of the pipette of said structure from the
body cavity into the containing structure, introducing the swab
into the body cavity, withdrawing the swab from the body cavity and
introducing said swab into said containing structure to wash the
samples of cellular material from the swab into the containing
structure, processing the samples of cellular material by
centrifuging the samples within said containing structure, and
eventually distributing the thus processed cellular material on a
microscope slide directly from said container structure.
5. Apparatus for procuring and processing samples of cellular
material from body cavities comprising in combination: a first
hollow member, a hollow tubular member of greater length than said
first hollow member, swab means, a cap detachably closing one end
of said tubular member to close said hollow tubular member, and
connector means operatively associated with said first hollow
member and said tubular member detachably assembling first hollow
member to said tubular member at the other end of said tubular
member, said swab means depending from the other end of said
tubular member into the interior of said first hollow member upon
assembly of said hollow member to said tubular member by said
connector means, at least one of said first hollow members and said
cap being of flexible material.
6. Apparatus for procuring and processing samples of cellular
material from body cavities comprising in combination a first
hollow flexible member, a hollow tubular member of greater length
than said first hollow member, a swab means, a cap detachably
closing one end of said tubular member to close said first hollow
member at said one end, and connector means operatively associated
with said members detachably assembling said first hollow member to
said tubular member at the other end of the latter, said first
hollow member containing a cell-preservative fluid, and said swab
means depending from said other end of said tubular member into the
interior of said first hollow member upon assembly of said first
hollow member to said tubular member by said connector means.
7. Apparatus according to claim 9, wherein said cap is
flexible.
8. A method for procuring samples of cellular material from a body
cavity and processing said cellular material to be conditioned for
analysis by utilizing a single container structure including means
forming a swab and a fluid container structure, comprising the
steps of at least partly filling said container structure with a
cell-preservative solution, introducing the swab into a body
cavity, withdrawing the swab from the body cavity and introducing
the swab into the fluid in said container structure to wash the
samples of cellular material from the swab into the fluid of said
container structure, and processing said samples of cellular
material directly in said container structure to condition the
cellular material contained in said solution for analysis whereby
the danger of cross-contamination is substantially eliminated.
9. A method according to claim 8, further comprising the step of
first irrigating the body cavity by the use of the fluid in said
container structure to wash out the cells from the cavity.
10. A method according to claim 8, wherein the step of processing
the samples of cellular material includes centrifuging the solution
containing the samples within the fluid container structure.
11. A method for procuring samples of cellular material from a body
cavity and for processing the procured samples of cellular material
by utilizing a single-pipette structure having a first portion
adapted to be used for procuring cellular material, a fluid
container containing a fluid and a second portion adapted to be
used as an auxiliary pipette, comprising the steps of introducing
the first portion into a body cavity, withdrawing the first portion
from the body cavity and introducing the first portion into the
fluid container to wash the samples of cellular material from the
first portion into the fluid in said fluid container, and
thereafter processing the samples of cellular material directly in
said fluid container structure for eventual analysis whereby the
danger of cross-contamination is substantially eliminated.
12. A method according to claim 11 wherein the step of processing
includes concentrating by centrifuging or sedimenting the cellular
material in said fluid container.
13. Apparatus for procuring and processing samples of cellular
material within the apparatus to minimize the danger of
cross-contamination comprising in combination: a tubular portion
open at both ends, means forming a structure for gathering cellular
material from a body cavity, a first closure member detachably
closing one end of said tubular portion, a second closure member,
at least one of said closure members being provided with a flexible
wall portion constituting a flexible bulb, and connecting means
selectively including first means detachably connecting said
structure to the other end of said tubular portion, second means
selectively and detachably connecting the one closure member
constituting said bulb member with the other end of said tubular
portion to constitute pipette means, and third means selectively
and detachably connecting the other one of said closure members
with said other end of the tubular member to enable use of said
other closure member as a centrifuging container.
14. Apparatus for procuring and processing samples of cellular
material comprising in combination: a first hollow flexible member
having only one open end, a second hollow flexible member having
only one open end, a tubular portion open at both ends, a further
element for obtaining cellular samples from a body cavity, first
connector means detachably assembling said first hollow member with
said tubular portion to provide a first pipette structure with said
first hollow member constituting a pipette bulb, second connector
means detachably assembling said second hollow member with said
first pipette structure to effectively provide a closure member
therefor, and third connector means adapted to detachably assemble
said second hollow member with said tubular portion upon removal of
said first hollow member to effective provide a second pipette
structure, and further means detachably assembling said further
element and said tubular portion.
15. Apparatus according to claim 19 wherein said first hollow
member is of a physical strength sufficient to enable it to be used
as a centrifugal container when disassembled from said tubular
member.
16. A structure for procuring and processing samples of cellular
material from a living body which minimizes the danger of
cross-contamination, comprising: a first hollow member, a second
hollow member, said hollow members being open at only one end
thereof, a tubular portion open at both ends thereof, at least one
of said hollow members being provided with flexible wall means
constituting a bulb, a structure for removing the samples of
cellular material from the living body, means operatively
associated with said hollow members and said tubular portion and
constituting connecting means including first means detachably
connecting said hollow members and said tubular portion in such a
manner that one hollow member is connected to one end of said
tubular portion and the other hollow member is connected to the
other end thereof and to enable disassembly of said members to
constitute one of said hollow members a centrifuging container, and
further means detachably connecting said structure to the end of
said tubular portion to which said one hollow member is normally
connected, said tubular portion being considerably longer than said
hollow members.
Description
The present invention relates to the processing of samples of
cellular material collected from body cavities for microscopic
examination and to apparatus for the collection of such
samples.
In my copending application, Ser. No. 199,373 filed June 1, 1962,
now abandoned, there is described a method and apparatus for
obtaining and processing samples of cellular material from body
cavities for microscopic examination which permits the use of
untrained personnel to procure such samples. While the method and
apparatus described in my copending application are eminently
satisfactory for the purpose, microscopic slides prepared from such
samples do not invariably contain as high a positive cell count as
is usually desired by pathologists.
It is a purpose of the present invention to provide a method which
enables individual cell specimens to be processed safely without
the danger of cross-contamination.
It is a further purpose of the invention to provide a method which
enables the use of the same apparatus for the entire processing
whereby the danger of cross-contamination is avoided.
It is a further purpose of the invention to provide a method which
enables all the necessary steps to be accomplished by means of one
single apparatus, thereby obviating the necessity of multiple
pipettes, aspiring syringes, collection bottles, etc.
It is a further purpose of the invention to provide a method which
eliminates the need for using and washing multiple items of
laboratory equipment.
It is a further purpose of the invention to provide a method which
expedites the processing and cuts down the time required in the
laboratory.
Still a further purpose of the invention is to provide the method
which enables improvement of the quality of the microscopic
preparations and thereby renders the microscopic examination more
rapid and accurate.
It is a further purpose of the present method to provide means of
effecting a specific cellular sampling from the squamocolumnar
juncture of the cervix, irrespective of normal anatomic
variations.
It is a further purpose of the present method to eliminate the need
for spreading and fixation of the cellular material on a
microscopic slide at the time of collection, thus simplifying the
procurement of the sample.
It is a further purpose of the present method to secure a richer
sample of atypical or positive cells for analysis than heretofore
possible to recover and concentrate on a single microscopic slide
in the laboratory.
It is a further purpose of the present method to assure a random
mixture of atypical and positive cells with the normal cells on the
microscopic slide, so that the probability of any individual
microscopic field containing diagnostic cells is greatly
increased.
It is a further purpose of the present method to assure fixation
and distribution of the cellular material under laboratory control,
so as to assure greater uniformity and quality of the microscopic
preparations.
It is a further purpose of the invention to provide an apparatus
for carrying out the method.
Among other purposes of the invention one purpose is to provide an
apparatus which enables the utilization of a single container
structure as a collecting as well as shipping and processing
container.
Still a further purpose of the invention is to provide apparatus
for the purpose specified, a part of which can be used as a
centrifugal container for processing the sample material and
another part of which can be used as a pipette for aspiring
material from said centrifugal container and distributing the
material directly on a microscopic slide.
Further purposes of the invention will appear from the following
specification in connection with the accompanying drawing, in
which
FIG. 1 is a perspective view of one embodiment of the pipette of
the invention,
FIG. 2 is a perspective view of the pipette shown in FIG. 1
illustrating its parts unassembled,
FIG. 3 is a detailed perspective view of the swab assembly of the
pipette shown in FIG. 1,
FIG. 4 is a schematic partial longitudinal section through the
pipette shown in FIG. 1,
FIG. 5 is a longitudinal section through a modified portion of the
pipette of the invention,
FIG. 6 is a longitudinal section further illustrating the
modification of FIG. 5.
FIG. 7 is a schematic perspective view of the pipette of the
invention illustrating one step of the method,
FIG. 8 is a schematic perspective view of the pipette of the
invention illustrating another step of the method,
FIG. 9 is a schematic perspective view of the pipette of the
invention illustrating a further step of the method,
FIG. 10 is a perspective view of the pipette of FIG. 1 with its
parts differentially assembled to illustrate a still further step
of the method,
FIG. 11 is a detailed perspective view of a modification of a
portion of the pipette of the invention,
FIG. 12 is a schematic perspective view of one step of the method
using the modification shown in FIG. 11,
FIG. 13 is a perspective view of the pipette structure shown in
FIG. 1, illustrating its use in preparing a microscope slide.
FIG. 14 is a schematic longitudinal sectional view of a further
modification of the invention.
FIG. 15 is a cross-sectional view of FIG. 14 through 15-15.
The invention provides a method for procuring and processing
samples of cellular material by utilizing a single container
structure which comprises the steps of effectively obtaining
cellular material from a body cavity, washing said cellular
material into said container structure, shipping said container
structure to a laboratory for processing said cellular material
exclusively within said container structure to condition said
cellular material for microscopic examination, and eventually
distributing said cellular material on a microscope slide directly
from said container structure.
More specifically the invention provides a method for procuring and
conditioning samples of cellular material for microscopic
inspection by means of a single container structure which includes
pipette means comprising the steps of collecting cellular material
such as from a body cavity of a human being, washing said cellular
material from the collecting means into said container by means of
a solution within said container, shipping said container and
pipette structure with the solution contained therein to a
laboratory, processing said solution by centrifuging or sedimenting
within said container structure to effectively condition the
cellular material contained in said solution for microscopic
examination, and eventually distributing said cellular material
directly from said container by means of said pipette means on a
microscope slide.
The invention provides apparatus for procuring and processing
samples of cellular material by means of a swab or scraper which
comprises first means effectively providing a container for a
fluid, second means effectively providing a swab or scraper for the
collection of cellular material and a third means effectively
providing a pipette structure having a bulb and tubular portion.
Said container, said swab or scraper and said pipette structure are
assembled in a manner to provide easy separation so as to render
the container operable as a centrifuge tube for processing the
cellular material and conditioning said cellular material for
microscopic examination. The structure also includes means operable
to render said tube effective as a pipette for the withdrawal of
cellular material from said centrifuge tube.
Referring now to the accompanying drawing, and specifically to
FIGS. 1 through 4, the container structure is outwardly formed in
three parts, a liquid container 16 which also effectively provides
a centrifuge tube, a tubular structure 7 which effectively provides
a pipette tube and a cap 1 which effectively provides a pipette
bulb.
One end of tubular structure 7 is provided with a flange 9 having
extending from it a tubular portion 10. Tubular portion 10 is
detachably inserted into the open end of container 16 to form a
liquidtight fit. The liquidtight fit may be provided by any
conventional means, such as a force fit, heat sealing or gluing.
The other end of tubular structure 7 is desirably provided with two
circumferential ridges 12 and 13 which are spaced from the other
end of the tubular structure and from each other. The cap 1
detachably covers the end of tubular structure 7 and desirably may
be internally provided with circumferential recesses 4 and 5 which
are spaced from one another to provide a liquidtight fit when
circumferential ridges 12 and 13 snap into them.
A swab structure of the type illustrated in FIG. 3 is provided for
the collection of cellular samples. The swab structure is an
elongated member 20 having attached at one end a soft flexible
material and at the other end appropriate means for detachably
assembling the swab structure to the tubular structure 7. The soft
flexible material may be any appropriate material such as rayon,
cotton or a foamed plastic such as polyurethane foam. As
illustrated, the soft flexible material is a tube 24 of
polyurethane foam, closed at one end. The soft flexible material
may be attached to the elongated member by any appropriate means,
so long as it is prevented from becoming detached. Again as
illustrated, in FIG. 3, the attachment is accomplished with a
toothed member 21 which permits the sleeve 24 to freely slide
thereover, but which prevents it from being removed. At the other
end of the elongated member 20 there is provided means for
detachably attaching the swab assembly 19 to the tubular structure
7. This may be accomplished by any appropriate means. One manner of
attaching the swab assembly 19 to the tubular structure 7 is to
provide one end of said swab assembly with footed prongs 22 which
are circumferentially arranged around the elongated member 20, said
footed prongs being of sufficient length to fit snugly into the
cavity of the hub 10 of the tubular structure 7. To prevent the
dislodgement of the swab assembly 19 during use, it is desirable to
provide an extension 23 at the pronged end of the swab assembly,
which extension 23 fits into the cannula of tube 8.
The method of procuring and processing cellular material is as
follows:
The seal between the tubular structure 7 and the container 16 is
broken in the manner shown in FIG. 7. Cellular samples are taken
from the site to be examined by swabbing the site as shown in FIG.
8, in which case the site examined is the cervix The cellular
material is then washed from the swab into the container 16 as
shown in FIG. 9. The cellular material is concentrated in the
container 16, preferably by centrifugation. The supernatant
solution is removed, as by decanting and a fixing solution is
placed in the container 16 and is mixed with the cellular material.
The cellular material can be further processed by:
a. separation from the supernatant fixing solution, by
sedimentation or centrifugation, and distribution on a microscope
slide for examination of further processing or
b. by the addition of staining agents to the container 16; further
processing may be carried out directly prior to the examination of
the material.
The structure of the present invention provides a single unit, the
components of which serve all of the apparatus necessary to
collect, contain and process cellular material without the danger
of cross-contamination.
The structure is delivered to the physician prefilled with a
preservative solution. Cellular material can be collected by the
physical and is either processed and examined immediately by the
physician or shipped in the structure to a laboratory for
processing and examination.
FIGS. 5 and 6 illustrate a modification of the cap 1 wherein the
cap is provided with an internal nib 6 which depends from the inner
end of said cap. The nib is such diameter that when the cap 1 is
fitted over the end of the tubular member 8, the nib enters the
opening 15 and forms a liquidtight seal, thus preventing leakage of
the liquid.
A modification of the invention is shown in FIGS. 11 and 12. In
this embodiment of the invention, the swab assembly 19 is replaced
by the scraper assembly 119. Scraper assembly 119 is an elongated
member 120 having at one end a flattened rigid scraper 124 which is
adapted to collect cellular material from the anterior and
posterior lips of the cervix and from the external os. The scraper
124 is attached to prongs 122 by a shank 120. The shank extends
beyond prongs 122 to form an axial rod 123. The prongs 122 are of
such dimension to form a snug fit in the hub 110, with the axial
rod 123 extending into cannula 111 of tube 108 to help provide
stability. The method of taking a scraping with the scraper
assembly 119 is illustrated in FIG. 12.
The device of the invention is used not only to collect cellular
samples, but is also to process the samples and to prepare the
microscope slides.
After obtaining the sample, the swab 24 or the scraper 124 is
washed in the fluid 18 which is contained in container 16, to
remove the cellular material from the swab or scraper. The
container is then placed in a standard centrifuge and the cells are
concentrated at the bottom of the container 16. The supernatant
fluid is decanted and a fixing solution is admixed with the
cellular material in container 16. The mixture is recentrifuged to
again concentrate the cellular material in the bottom of container
16.
Cap 1 is then inserted into hub 10 end of pipette assembly 7 so as
to form a pipette.
As shown in FIG. 10, the thus formed pipette is used to suck the
cellular material out of container 16. The cellular material is
placed onto a microscope slide 26 by squeezing cap 1.
The distribution of the cellular material on microscope slide 26 is
accomplished as illustrated in FIG. 13. The cellular sample is
distributed in the form of an even layer because of the
circumferential ridges 12 and 13 on tube 8 which permit the surface
of the portion 14 to be spaced from the surface of the microscope
slide a distance which is substantially that of the desired
thickness of the sample layer.
Obtaining cellular samples by routine spatula scraping has the
advantage of permitting the preparation of a microscope slide from
a specific site under direct vision. For example, the usual site of
early cervical cancer is the squamocolumnar juncture, accessible to
routine spatula collections. But the juncture may be withdrawn into
the cervical canal, routine wooden spatula scraping may be
ineffective to obtain samples from this site. The collapsible
nature of the swab or sponge modification and the present invention
permits introduction of the collecting surface of the present
device into the cervical canal, to obtain good samples even in the
face of such anatomic variations.
A further embodiment of the invention is useful for obtaining
cellular samples to include cells exfolicting from still higher
levels. This modification is illustrated in FIGS. 14 and 15 wherein
the shank 20 of swab assembly 19 has disposed at one end thereof
channels 225 extending through mount 22. By substituting this swab
assembly for the swab assembly shown in FIG. 2, the device may be
used first to irrigate the body cavity from which the cellular
material is to be obtained in order to wash out the cells from the
cavity, and then the device is used as hereinbefore described to
obtain samples by swabbing or scraping.
Irrigation is accomplished by removing the cap 1 from the pipette
7, inserting the tubular member 8 into the vagina until only the
container 16 is exposed, squeezing the container 16 to eject the
irrigating solution, releasing the pressure on the container to
reaspirate the irrigating solution together with cellular material
suspended in the solution. If desired, the irrigation can be
repeated several times. After completion of the irrigation,
additional cellular material may be obtained by swabbing or
scraping.
It will be appreciated that for the irrigation procedure, the
container 16 must be formed of a resilient, flexible material. The
cap 1 should be formed of a similar material.
The solution with which container 16 is prefilled, where to be used
as an irrigating solution must be capable of such use without
injury to body tissue. It must also be capable of inhibiting
decomposition of the cellular material; however obtained.
I have found that a suitable solution for use with my invention
comprises a mixture of alcohol and physiological salts to which has
been added a small amount of a fungicide or antibiotic. The saline
concentration should be sufficient to prevent the cells from
swelling or shrinking. The alcohol concentration should be high
enough to inhibit bacterial growth and/or decomposition of the
cellular material, but low enough not to injure the patient or
alter the cells in such a manner as to make further processing
difficult. The concentration of the fungicide or antibiotic should
be sufficient to ensure against decomposition of the solution on
prolonged storage.
* * * * *