U.S. patent number 3,608,539 [Application Number 04/773,787] was granted by the patent office on 1971-09-28 for method for the biopsy of subcutaneous masses.
Invention is credited to Daniel G. Miller.
United States Patent |
3,608,539 |
Miller |
September 28, 1971 |
**Please see images for:
( Certificate of Correction ) ** |
METHOD FOR THE BIOPSY OF SUBCUTANEOUS MASSES
Abstract
An instrument for the biopsy of subcutaneous masses includes an
arcuate cannula having a serrated distal cutting end and is
provided for alternative insertion, a correspondingly curved
pointed stylet and a flexible ejector element. In performing a
biopsy, and the skin is punctured and the cannula engaged stylet
inserted through the puncture into the surface of the mass from its
lateral or inferior aspect. The stylet is removed and the cannula
advanced through the mass to cut and draw a specimen thereof into
the cannula and the cannula is pushed through the overlying tissue
to the skin, which is then punctured and the distal end of the
cannula pushed through the puncture. The ejector is then pushed
through the proximal end of the cannula to eject the specimen.
Inventors: |
Miller; Daniel G. (New York,
NY) |
Family
ID: |
25099302 |
Appl.
No.: |
04/773,787 |
Filed: |
November 6, 1968 |
Current U.S.
Class: |
600/567; 606/117;
606/187 |
Current CPC
Class: |
A61B
10/0266 (20130101) |
Current International
Class: |
A61B
10/00 (20060101); A61b 010/00 (); A61b 017/34 ();
A61b 017/32 () |
Field of
Search: |
;128/2,305,314,329,347 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Pace; Channing L.
Claims
What I claim is:
1. The method for obtaining a biopsy of a subcutaneous mass
comprising the steps of advancing a cannula inwardly through a
first area of the skin laterally of the area above the mass and
through said mass to undercut and receive a specimen from said mass
and thence advancing said cannula with the specimen therein
outwardly through a second area of the skin, on the side of the
area above the mass opposite the first area and thereafter ejecting
said specimen from said cannula while projecting through said
skin.
2. The method of claim 1, wherein said cannula is advanced through
said first skin area to said mass, while engaged by a stylet
provided with a pointed end positioned at the distal end of said
cannula, and removing said stylet from said cannula prior to said
cannula being advanced through said mass.
3. The method of claim 1, wherein said specimen is ejected through
said cannula by advancing a plunger through said cannula.
4. The method of claim 1, including the step of puncturing said
first area of said skin with a sharp instrument prior to the
insertion of said cannula.
5. The method of claim 1, including the step of puncturing the skin
at said second area following the penetration of the mass by the
cannula and before the emergence of the cannula through said second
area.
6. The method of claim 1, including the step of applying pressure
to said mass through the surrounding tissue in a direction towards
said cannula during the advance of said cannula through said mass.
Description
BACKGROUND OF THE INVENTION
The present invention relates generally to improvements in sampling
methods and instruments and it relates particularly to an improved
method and instrument for obtaining biopsy specimens from
subcutaneous masses, such as lymph nodes or tumors.
The procedures conventionally employed for obtaining biopsy
specimens pose numerous drawbacks and disadvantages, particularly
when applied to subcutaneous masses. They are usually accompanied
by damage to the surrounding tissue as the result of surgical
incision and disection, and frequently effect the transfer of some
of the sampled mass to the surrounding tissue, a consequence which
is highly undesirable and should be assiduously avoided. Moreover,
when straight needles are employed to obtain biopsies of lymph
nodes or subcutaneous masses, the plug which is impaled in the
barrel, in most instances will remain in situ when the needle is
withdrawn, because its distal end has not been severed from the
bulk of the mass. These tissues possess an inherent elasticity and
connective tissue framework, which is resilient and has sufficient
strength to retain a specimen which is cut on only three sides. It
is because of this common experience that needles previously used
for this purpose employed various undercutting mechanisms for
retaining the cut plug, e.g. a screw, a hook, compressible jaws or
a side cutting device.
SUMMARY OF THE INVENTION
It is a principal object of the present invention to provide an
improved sampling method and instrument.
Another object of the present invention is to provide an improved
method and instrument for obtaining biopsy specimens.
Still another object of the present invention is to provide an
improved method and instrument for obtaining biopsy specimens of
subcutaneous masses.
A further object of the present invention is to provide an improved
method and instrument for obtaining biopsy specimens of
subcutaneous masses with a minimum of damage to the surrounding
tissue and the obviation of any transfer of the sampled mass to the
surrounding tissue.
Still a further object of the present invention is to provide a
method of the above nature, characterized by its convenience,
simplicity, high reliability, versatility and minimum discomforture
to the subject.
The above and other objects of the present invention will become
apparent from a reading of the following description taken in
conjunction with the accompanying drawing, which illustrates a
preferred embodiment thereof.
In a sense the present invention contemplates the provision of the
method for obtaining a biopsy of a subcutaneous mass comprising the
steps of advancing a curved cannula through a first area of the
skin, through said mass to cut and receive a specimen thereof, and
thence through a second area of the skin, and thereafter ejecting
said specimen from said cannula while projecting through the skin
of the second area. The cannula is advantageously curved and
preferably arcuate with a radius of curvature advantageously
between 3 and 5 centimeters and advantageously extends between
45.degree. and 180.degree., preferably between 120.degree. and
130.degree., and is of a length between 5 and 12 centimeters. The
distal end of the cannula is provided with a serrated cutting edge
and the proximal end is provided with finger engageable wings. A
similarly curved stylet is slidably received within the cannula and
is provided with a proximal button and a distal pointed tip
projecting through the cannula distal end. A blunt ended flexible
ejector is slidably received within the cannula alternatively with
the stylet. According to the preferred procedure, the skin on one
side of the mass is punctured and the stylet engaged cannula
inserted therethrough and advanced into engagement with the mass.
The stylet is then removed and the cannula advanced through the
mass to obtain a specimen thereof and thence through the
surrounding tissue and another skin opening. The ejector is pushed
through the proximal end of the cannula to eject the biopsy
specimen through the distal end thereof external to the skin.
The improved procedure is simple, rapid, convenient, versatile and
reliable. It results in a minimum of damage to the surrounding
tissue and prevents any transfer of the biopsied mass to the
surrounding tissue.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a front elevational view of the cannula section of an
instrument embodying the present invention;
FIG. 2 is a front elevational view of the stylet section
thereof;
FIG. 3 is a front elevational view of the ejector section
thereof;
FIG. 4 is an enlarged longitudinal sectional view of the distal end
of the assembled instrument;
FIG. 5 is an elevational view illustrating a step of preparing the
site in the practice of the improved process;
FIG. 6 illustrates the insertion of the cannula into the explored
mass;
FIG. 7 illustrates the obtaining of the biopsy specimen;
FIG. 8 illustrates the preparation of the skin exit site; and
FIG. 9 illustrates the ejection of the biopsy specimen.
DESCRIPTION OF THE PREFERRED EMBODIMENT
Referring now to the drawing, and particularly FIGS. 1 to 4
thereof, which illustrate an instrument embodying the present
invention, the improved instrument includes a cannula 11, a stylet
or piercing member 12, and an ejector member 13. The cannula 11
comprises an arcuate tubular body member or barrel 14, provided at
its distal end with a sharp serrated cutting edge 16, as best seen
in FIG. 1. The bore of the cannula barrel 14 is uniform throughout
its length, the outer face at the distal end being tapered to the
cutting edge 16.
An annulus 17 is fitted over the proximal end of the barrel 14 and
a wing-shaped finger piece provided with a medial opening is also
fitted over the proximal border of the barrel 14 and rests on the
annulus 17. A standard Luer-lok receptacle or coupling collar 19
engages the distal end of the barrel 14 and is affixed to the
barrel 14 with the annulus 17 and finger piece 18, by soldering,
welding or the like.
The stylet 12 includes an accurately shaped rod 20 of the same
curvature as the cannula barrel 14, and is of lesser
cross-sectional diameter than the bore of the barrel 14. The rod 20
terminates at its distal end in an enlarged pointed tip 21 and is
provided at its proximal end with a thumb rest or button 22. The
cannula 11 and stylet 12 are so dimensioned that when the stylet 12
is fully inserted in the cannula 11, the button 22 rests on the
coupling collar 19 and the tip 21 projects through the distal end
of the cannula barrel 14 with its face forming a smooth continuous
surface with the outside face of the cannula barrel distal border,
as seen best in FIG. 4.
The ejector member 13, is a flexible rod or wire of an outside
diameter, about equal to the inside diameter of the barrel 14, and
is provided with a blunt distal end face 23. The ejector member 13
is advantageously formed of Teflon rod or other suitable
material.
As a specific example, the cannula barrel 14 is formed of stainless
steel with an inside diameter of 3 millimeters and an outside
diameter of 4 millimeters. The overall length of the cannula barrel
14 is 10 centimeters and the chord distance from end to end is
about 9 centimeters. It has a radius of curvature of about 4.5 cm.
and extends for about 120.degree.. The taper leading to the cutting
edge 16 is about 4 millimeters long. The rod 20 is stainless steel
of 2 millimeters diameter and the conical tip 21 is 6 millimeter
long.
Considering now the practice of the improved method employing the
instrument described above, and referring to FIGS. 5-9 of the
drawing, the skin S, about 2 centimeters from the mass M which is
to be biopsied, is infiltrated with procaine and from this side
additional procaine is injected subcutaneously about mass M. Skin S
is punctured, as seen in FIG. 5, with a surgical blade 26 in an
area slightly offset from the side of mass M. The opening in the
skin is further enlarged by stretching with a small curved hemostat
or pointed scissors, not shown. With the same instrument a tract is
made to the mass M by penetration and separation of the
subcutaneous tissue. The cannula 11, with the pointed stylet 12 in
place is then inserted along the prepared tract and inserted into
the side of or the undersurface of the mass M, as seen in FIG. 6.
The free hand can often assist by holding the mass. After entry has
been confirmed by moving the cannula 11 and mass M as one, the
pointed stylet 12 is removed. With the thumb of the free hand, the
mass M is pushed down and in this manner the open cannula 11
traverses one entire diameter of the mass M, as seen in FIG. 7. In
some situations it is advantageous to rock the proximal end of the
cannula to and fro; this turns serrated cutting edge 16 of barrel
14 and facilitates its passage through the mass M. When the mass M
has been penetrated, the arc is further extended to raise the skin
S at the opposite side of the mass M. With procaine, puncture and
tract prepared as above, as seen in FIG. 8, the specimen loaded
cannula 11 emerges. The clearing stylet or ejector 13 is inserted
in the cannula 11, as shown in FIG. 9, and the specimen is picked
up on either a square of blotting paper or with thumb forceps and
dropped into a bottle containing the fixing solution. The cannula
11, is easily withdrawn by reversing the direction of the arc.
Pressure is applied to the punctures for 2 minutes and two
Band-Aids are applied to each of the two puncture sites and left in
place for 24 hours.
In employing the improved instrument in the method described above,
highly satisfactory biopsy specimens were obtained and the proper
diagnosis made in a large number of patients. No false negative
diagnosis were encountered. It is important to note that there were
no complications associated with the improved procedure. The
specimens biopsied represented a variety of lesions from the point
of view of size, consistency and diagnosis and the improved method
has proven sufficiently versatile to adapt to most of the
situations encountered.
While there has been described and illustrated a preferred
embodiment of the present invention, it is apparent that numerous
alternations, omissions and additions may be made without departing
from the spirit thereof.
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