U.S. patent number 3,595,217 [Application Number 04/732,180] was granted by the patent office on 1971-07-27 for fine needle aspiration biopsy of prostate.
Invention is credited to Robert E. Rheinfrank.
United States Patent |
3,595,217 |
Rheinfrank |
July 27, 1971 |
FINE NEEDLE ASPIRATION BIOPSY OF PROSTATE
Abstract
A method and means for biopsy of the prostate gland utilizing
cytologic studies as a basic for presumptive diagnosis. A biopsy
needle is passed through a guide which may be fixed to the
operator's gloved finger by a ring member. After the guide is
placed on the finger, a finger cot is applied over the apparatus
and finger for sterility and to facilitate insertion of the guide
and finger internally of the body. The needle is then inserted
through the guide and into the substance of the prostate. A syringe
is attached to the needle and utilized for withdrawing a tissue
sample whereupon slides are prepared for diagnosis of prostatic
malignancy.
Inventors: |
Rheinfrank; Robert E. (Tulsa,
OK) |
Family
ID: |
24942500 |
Appl.
No.: |
04/732,180 |
Filed: |
May 27, 1968 |
Current U.S.
Class: |
600/567;
600/566 |
Current CPC
Class: |
A61B
10/0241 (20130101); A61B 2018/00547 (20130101); A61B
2017/00274 (20130101) |
Current International
Class: |
A61B
10/00 (20060101); A61B 17/00 (20060101); A61b
005/00 () |
Field of
Search: |
;128/2,1,350,221,340,362,215,276,277,278,303,328,214.4 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Dunne; G. F.
Claims
What I claim is:
1. A guide for biopsy needle comprising needle receiving means,
finger receiving means secured to the needle receiving means, and
stabilizing means adjustably secured to the needle receiving means
for facilitating handling thereof during a biopsy procedure, said
stabilizing means comprising a disc member, a sleeve carried by the
disc member for slidably receiving the needle receiving member
therethrough, and means carried by the sleeve and engageable with
the needle receiving means for selectively securing the disc to the
needle receiving means.
2. A guide for a biopsy needle comprising needle receiving means,
finger receiving means secured to the needle receiving means, and
stabilizing means adjustably secured to the needle receiving means
for facilitating handling thereof during a biopsy procedure, said
needle means comprising an elongated tubular member having the
opposite ends thereof open for slidable receiving the needle
therethrough, one of said open ends being flared for facilitating
insertion of the needle therein, said finger receiving means
comprising an annular member adapted for receiving a finger
therein, said tubular member being provided with an arcuate portion
for facilitating guiding of the needle, said annular member being
secured to the tubular member in the proximity of the opposite open
end thereof, said stabilizing means comprising a disc member, a
sleeve member carried by the disc member for slidably receiving the
tubular member therethrough, setscrew means carried by the sleeve
and engageable with the tubular member for selectively securing the
disc member on the tubular member, and said tubular member being
provided with an arcuate portion in the proximity of the annular
member for facilitating handling of the guide and guiding the
needle passing therethrough during a biopsy procedure.
Description
This invention relates to improvements in biopsy methods and means
and more particularly, but not by way of limitation, to a method
and means for biopsy of the prostate gland utilizing cytologic
studies for presumptive diagnosis.
A method of biopsy of the prostate gland utilizing cytologic
studies as a basis for presumptive diagnosis was first developed
and introduced in Sweden and has been of great advantage in the
detection of prostatic malignancy, or the like. However, certain
disadvantages are present in the method in that the equipment used
is often of a size causing discomfort to the patient.
The present invention contemplates an improvement in the technique
of this type of biopsy which is considered to be a step forward in
earlier diagnosis of prostatic malignancy. A guide device has been
particularly designed and constructed for disposition on the gloved
finger of the operator by means of a ring. The usual finger cot may
then be applied over the finger and apparatus for sterility and to
facilitate insertion of the finger and guide into the rectum of the
patient. The biopsy needle is then inserted through the guide and
transrectally into the substance of the prostate. A syringe is
attached to the needle and suction is produced by pulling on the
plunger of the syringe. A to-and-fro or in-and-out movement of the
syringe and needle is produced while exerting suction, whereby
movement is effected to disturb the prostate tissue sufficiently so
prostatic cells and fluid are aspirated into the needle. The
suction is then released and the needle is removed or withdrawn
from the tissue. Cellular debris remains in the lumen of the
needle, and the needle is then removed from the guide. Several
slides are then prepared for the analysis of the cellular debris.
The quantity of the debris and the method of preparing the slides
provides excellent nuclear detail, thus enabling classification of
the cells according to Papanicolaou's criteria. The outstanding
results possible by study of the slide prepared in accordance with
the invention appears to be the visualization of the nucleoli. The
pleomorphism of the nucleoli and increase in number of the
macronucleoli can easily be seen, thus providing an earlier
diagnosis of prostatic malignancy.
It is an important object of this invention to provide an improved
method and means for biopsy of prostate utilizing cytologic studies
as a basis for presumptive diagnosis.
It is another object of this invention to provide a guide for a
biopsy needle which greatly facilitates the insertion of the needle
into the rectum of the patient and into the substance of the
prostate.
Another object of this invention is to provide a novel guide and
biopsy needle and method particularly designed and developed for
improving the removal of cellular material from the prostate for
biopsy purposes.
Still another object of this invention is to provide a method of
preparing slides from the cellular material removed from the
prostate for improved diagnosis of prostatic malignancy.
A further object of this invention is to provide an improved method
and means for biopsy of prostate wherein visualization of the
nucleoli is greatly increased.
Other and further objects and advantageous features of the present
invention will hereinafter more fully appear in connection with a
detailed description of the drawings in which:
FIG. 1 is a side elevational view of a fine needle aspiration
biopsy device embodying the invention and disposed in the hands of
an operator.
FIG. 2 is a perspective view of a guide device embodying the
invention.
FIG. 3 is a broken sectional elevational view of the guide device
shown in FIG. 2.
Referring to the drawings in detail, reference character 10
generally indicates a needle guide comprising an elongated tube 12
having one end 13 thereof open and a flared sleeve member 14
secured thereto for facilitating insertion of a biopsy needle 16
therein. The opposite end 18 of the tube 12 is also open whereby
the needle 16 may pass completely through the tube for a purpose as
will be hereinafter set forth. A ring or annular member 20 is
secured to the end 18 of the tube 12 in any suitable manner. As
shown herein, the ring 20 is provided with an enlarged
circumferential portion 22 having a longitudinal bore 24 extending
therethrough for receiving the end 18 therein. The end 18 may be
soldered or otherwise rigidly secured within the bore 24 for
securing the ring 20 to the tube 12.
A disc member 26 is provided with a diametrically extending sleeve
28 secured to one face thereof for slidably receiving the tube 12
therethrough. An outwardly extending sleeve 30 is suitably secured
to a bore 32 provided in the sleeve 28 and is internally threaded
for receiving a thumbscrew or setscrew 34 therein. The disc 26 may
be positioned at substantially any desired position on the tube 12
for stabilization thereof during use and may be securely retained
in the selected position by threading the screw 34 in the sleeve 30
until the screw 34 bears against the outer periphery of the tube
12. The tube 12 is preferably provided with an arcuate portion 35
in the proximity of the end 18 whereby the overall configuration of
the tube 12 is generally complementary to the configuration of the
internal portions of the body wherein the device is to be inserted,
as will be hereinafter set forth. Of course, the disc 26 may be
positioned on the tube 12 as desired for facilitating the holding
of handling of the device 10 as will be hereinafter set forth.
In use, the operator or user of the invention initially puts on the
usual sterile gloves 36 and the guide 10 may be fixed to the
operator's gloved index finger 38 by the ring 20. The usual finger
cot (not shown) is then applied to the finger 38 over the guide
device 10 to maintain sterility and to facilitate insertion of the
finger into the rectum of the patient (not shown). The patient is
preferably draped in the normal lithotomy position (not shown) and
no special preparation technique in the office of the operator is
required. Only the preparations normally utilized for cystoscopic
examinations on hospitalized patients in the surgery suite are
required. As a practical matter it has been found that a prior
injection of any suitable mild analgesic agent is sufficient to
prevent undue discomfort to the patient when performing the
diagnostic method of the invention in the office of the
operator.
With the apparatus or guide 10 in position on the finger 38 the
disc 26 may be positioned along the tube 12 as desired for
facilitating handling of the guide 10 and maintaining a stability
for the tube 12. For example, as shown in FIG. 1, it may be
preferable to position the disc 26 in the proximity of the palm of
the hand, or it may be desirable to position the disc 26 in the
proximity of the base of the finger 38. In any event, the flared
sleeve or open end 14 of the tube 12 will be exposed in the
proximity of the palm of the hand for receiving the biopsy needle
16 therein.
When the guide 10 is properly disposed on the hand of the operator,
the index finger 38 is inserted into the rectum of the patient and
the prostate (and/or nodule, if present) is palpated, as is well
known. The configuration of the guide 10 substantially conforms to
the internal structure of the body in this area for facilitating
the insertion of the guide 10 and finger 38. The needle 16 is then
inserted into the flared sleeve 14 and through the tube 12 and
transrectally into the substance of the prostate or nodule. Whereas
the needle 16 may be of any suitable type, it has been found
preferable to use a 93/4 inch 22 g. needle, with the needle being
of either the long-bevel type or short-bevel type. The long-bevel
type needle is particularly useful in performing routine biopsy,
and the short-bevel type needle is particularly useful in
aspirating a discreet nodule or suspicious area. In performing a
routine biopsy, it is preferable to make two sets of slides (not
shown) as will be hereinafter set forth, and use two needles in
order that both lateral lobes may be examined.
When the needle 16 has been inserted into the substance of the
prostate, a suitable syringe 40 is secured or attached to the outer
end of the needle 16 in the usual manner. The syringe 40 may be of
any suitable type. However, a 20 cubic centimeter syringe has been
found to be very satisfactory. A to-and-fro (or in-and-out)
movement of the syringe 40 and needle 16 produced simultaneously
with the exertion of suction by the syringe. The purpose of this
movement is to disturb the tissue of the prostate or nodule
sufficiently so prostatic cells and fluid are aspirated into the
needle 16. The suction or negative pressure applied by the plunger
of the syringe is then released slowly prior to removal of the
needle from the tissue. This will permit the cellular debris (not
shown) to remain in the lumen (not shown) of the needle 16. The
needle 16 is then removed from the tissue of the prostate or nodule
and from the guide 10.
A plurality of slides (not shown) are prepared from the cellular
material or debris. This is accomplished by expressing a drop of
the bloody fluid (cellular debris) on each slide and very
delicately smearing the fluid with the flat surface of a second
slide, taking care not to spread the tissue elements off the end of
the slide being made. The smear is then allowed to air-dry until
the gloss or sheen has disappeared, and then the smear is fixed
with several drops of 95 percent alcohol, and again allowed to
air-dry. The slide is then ready for staining.
The present method has been successful in obtaining adequate tissue
and cellular material for cytological examination. When the slide
is stained with Giemsa and differentiated with Eosin, it has been
found that excellent nuclear detail is obtained, enabling
classification of the cells according to Papanicolaou's criteria.
However, the outstanding feature of this staining method is the
visualization of the nucleoli using this staining technique. The
pleomorphism of the nucleoli and increase in number of the
macronucleoli can easily be seen. As a result it is felt that a
step toward earlier diagnosis of prostatic malignancy may be
achiever. In addition, as a technique, the procedure is simple,
fast relatively atraumatic and safe, and to date there have been no
complications as a result of practicing the method or
technique.
From the foregoing it will be apparent that the present invention
provides a novel method and means for biopsy of the prostate gland
utilizing cytologic studies as a basis for presumptive diagnosis. A
guide member is particularly designed and constructed for
installation on the index finger and in the hand of the operator
whereby the biopsy needle may be more easily and readily inserted
transrectally into the substance of the prostate or nodule. A
syringe utilized in conjunction with the needle facilitates the
capture of cellular debris or tissue for examination purposes.
Slides are prepared from the tissue or cellular samples in a manner
wherein excellent nuclear detail is obtained for facilitation
classification of the cells according to Papanicolaou's criteria,
and visualization of the nucleoli is greatly improved by the use of
the staining technique. In addition, the device and technique are
simple, quick and efficient in results.
Changes may be made in the combination and arrangement of parts as
heretofore set forth in the specification and shown in the
drawings, it being understood that any modification in the precise
embodiment of the invention may be made within the scope of the
following claims, without departing from the spirit of the
invention.
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