 |
Description  |
|
|
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to a device for use in connection
with obtaining biopsy specimens such as, for example, from the breast,
thyroid, solid tumors, bone marrow, liver, kidney, pleura, synovia, and
other soft body tissue.
2. Description of the Prior Art
Prior art and conventional biopsy devices have not been successful in
providing a high quality extracted specimen while at the same time
minimizing trauma to the patient and providing easy removability of the
specimen from the device after extraction. In particular, there has now
been developed any generally acceptable biopsy device which provides the
aforementioned desirable advantages and which includes a rotatable inner
needle member.
Illustrative of prior art devices in the field of biopsy apparatus are
those disclosed in U.S. Pat. Nos. 2,541,542; 2,919,692; 3,175,554;
3,512,519; 3,628,524; 3,683,891; 3,800,783; 3,893,445; 3,913,566; and
3,949,747. Perez U.S. Pat. No. 2,541,542 discloses a chisel-pointed needle
with a cannula fitted with a small noose-like loop to cut a cylinder of
tissue after the needle is removed and the cannula is pushed further into
the tissue.
Ackerman U.S. Pat. No. 2,919,692 discloses an extremely thin needle for
guiding a cannula to a vertebral bone surface. The needle is withdrawn,
and replaced with a trephine to saw through the bone for a marrow sample.
Stewart U.S. Pat. No. 3,175,554 discloses a hollow bifurcated needle which
spreads when inserted past the end of a cannula into soft tissue, and
contracts when withdrawn trapping a tissue sample.
Hall U.S. Pat. No. 3,512,519 discloses a circular cutting device to be used
with high-speed pneumatic rotary surgical instruments for obtaining
shallow samples of the surface of skin or an organ exposed during an
operation.
Jamshidi U.S. Pat. No. 3,628,524 discloses an interlocked tube and needle
assembly. When the needle is removed, the biopsy sample is to expand into
the tapered interior of the tube.
Eskridge U.S. Pat. No. 3,683,891 discloses a flattened section of stainless
steel wire formed into a hollow helix.
Jamshidi U.S. Pat. No. 3,800,783 discloses a chisel pointed, barbed needle
which serves as a penetrator for the device, and is then extended to catch
a tissue sample in the barb.
Hofsess U.S. Pat. No. 3,893,445 discloses an outer hollow chisel pointed
tube intended to indent a bone surface, and an inner hollow chisel pointed
tube serving as a rotatable drill bit to drill through the bone marrow,
and thereafter to be removed to insert prior art cannulas or hypodermic
needles.
Lacey U.S. Pat. No. 3,913,556 discloses a disposable tool with a split
hollow tube to make a cylindrical cut in a tissue body, and be split apart
and re-inserted in the cylindrical cut to scoop out a tissue sample.
Hevesy U.S. Pat. No. 3,949,747 discloses a set of screw-together handles
and screw-on tissue biopsy punches, similar in configuration to common
leather punches, but much smaller. Such devices, however, have not
satisfactorily provided a safe and effective biopsy instrument capable of
producing high quality specimens, as is possible with the rotary biopsy
device of the present invention.
SUMMARY OF THE INVENTION
The present invention provides a device for extracting biopsy samples and
the like including an elongated needle member having a distal and proximal
end, the distal end defining a cutting edge for initial penetration of the
body tissue. The needle member has disposed along at least a portion of
the length thereof body tissue cutting means. A hollow cylindrical cutting
tube of substantially uniform diameter having a distal and proximal end
with the distal end defining a cutting edge is also provided. The tube is
adapted to be substantially tightly received over the needle member having
the cutting means disposed thereon, after the needle member has been
penetrated into the body tissue. The distal cutting edge of the tube
projects beyond the distal cutting edge of the needle member in the body
tissue when the tube is disposed over the needle member in an operative
position. The needle member and the tube are adapted to be withdrawn
simultaneously from the body with the tissue sample being collected
interiorly of the tube.
In a preferred embodiment, the body tissue cutting means comprises a sharp
helical thread disposed along a substantial portion of the length of the
needle member to effect a tissue-cutting action when the needle member is
rotated. The tissue sample is collected interiorly of the tube and between
adjacent thread portions of the helical thread when the needle member and
tube are simultaneously withdrawn from the body. Both the needle member
and the tube are provided with respective handles to aid in maneuvering
same, with the handle of the needle member being adapted to permit the
tube to be slidably received thereover. The distal cutting edge of the
tube is defined by a substantially circular beveled distal end edge of the
cylindrical cutting tube. In the operative position, the proximal end of
the needle member projects beyond the proximal end of the tube.
It is an object of the present invention to provide a method of utilizing
the rotary biopsy device wherein the needle member is inserted into the
body at a desired specimen extracting location by rotating the needle
member to permit the helical thread to cut the body tissue. Thereafter,
the cutting tube is slidably inserted over the needle member into the body
tissue, and both the needle member and tube are finally simultaneously
withdrawn from the body. The proximal end of the needle member projects
beyond the proximal end of the tube and the distal cutting edge of the
tube projects beyond the distal cutting edge of the needle in the body
tissue when the tube has been slidably inserted over the needle into the
body tissue in the operative position.
Further objects and details of the present invention will become apparent
to those skilled in the art upon reading the following specification,
appended claims, and the accompanying drawing.
Brief Description of the Drawings
FIG. 1 illustrates a side elevational view of the assembled biopsy device
in accordance with a preferred embodiment of the present invention.
FIG. 2 depicts a front elevational view of the inner needle member as
inserted into the body, with the outer tube being partially inserted
thereover.
FIG. 3 depicts a front elevational view of the device in an operative
position wherein the outer tube is fully inserted into the body tissue.
FIG. 4 illustrates a front elevational view of the device as the inner
needle member and outer tube are being simultaneously withdrawn from the
patient's body.
FIG. 5 depicts an enlarged cut-away sectional view of the specimen
collected interiorly of the tube and between adjacent thread portions of
the needle member.
DETAILED DESCRIPTION OF SOME PREFERRED EMBODIMENTS
There is hereby incorporated by reference thereto the entire disclosure of
the aforementioned copending U.S. patent application Ser. No. 684,480.
With reference to FIG. 1, there is depicted the novel rotary biopsy device
according to the present invention. The device includes an elongated solid
cylindrical needle member 1 which is shown as disposed within a hollow
cylindrical cutting tube 2. Both the needle 1 and the tube 2 are of
uniform diameter. The needle 1 has provided on the proximal end thereof a
handle 3 which is of slightly larger diameter than the needle 1, but which
is of sufficiently minimal diameter to permit the tube 2, of somewhat
larger diameter, to slide thereover. As can be seen in the cutaway portion
of the tube 2, the needle 1 has disposed along a suitable length thereof a
helical thread 4. The thread 4 has an acutely sharp cutting edge disposed
along the entire length of the thread 4 to facilitate the cutting action
as well as the specimen retaining action which will be described in
greater detail hereinbelow. Disposed adjacent the proximal end of the tube
2 is a handle portion 5. The handle 5 is fabricated of a rod portion 5a
which extends substantially perpendicular to the longitudinal axis of the
tube 2 and a knob 5b secured to the end of rod 5a.
The distal end 6 of the needle 1 comprises a sharp conical needle point
which permits the inital penetration of the needle 1 into the patient's
body to be relatively painless with minimal trauma. The distal end 7 of
the tube 2 also comprises a sharp cutting edge as will now be described
with reference to FIG. 2.
Although the device as depicted in FIG. 1 illustrates the needle 1 as being
disposed within the tube 2, it will now be understood with respect to FIG.
2 that initially the needle 1 and tube 2 are completely separated. To
commence the specimen-obtaining procedure, the needle 1 is employed, via
the sharp point 6, to initially puncture the layer of skin 8 of the
patient's body. Next, to facilitate penetration of the needle 1 into the
body tissue 9, the needle 1 is rotated, by rotating the handle 3 of the
needle 1, in the direction of the arrow shown in FIG. 2. Upon rotation,
the sharp helical thread 4 disposed along the length of needle 1 permits
the needle 1 to be worked into the patient's body with minimal pain and
trauma to the patient. After the needle 1 has been rotated and penetrated
into the body tissue 9 to the desired position, the outer tube 2 is
slidably positioned over the needle 1, and pushed downwardly towards the
skin 8. In this connection, it should be noted with respect to FIGS. 1-5
that the inside diameter of the tube 2 is only slightly larger than the
combined diameter of the needle 1 and the helical thread 4 disposed
thereon, to just ensure a substantially tight fit between the needle 1 and
the tube 2 inserted thereover. As can be seen in FIG. 2, the sharp distal
cutting edge 7 of the tube 2 comprises a bevelled end edge thereof which
is substantially circular in configuration. The edge 7 is extremely sharp
to effect easy penetration of the tube 2 into the skin layer 8 and
subsequently into the body tissue 9.
Referring now to FIG. 3, the tube 2 is illustrated as fully inserted into
body tissue 9 in its operative position. The tube 2 has been pushed
downwardly in the direction of the arrow shown in FIG. 3, and it should be
noted that no rotational movement of the tube 2 is necessary to effect
penetration, and indeed a pushing action is all that is required. In this
connection, the handle 5 for the tube 2 (FIG. 1) is employed to facilitate
maneuvering of the tube 2 with respect to the needle 1 and the patient's
body. Also, it should be noted that as the tube 2 is pushed downwardly
over the needle 1, the needle 1 remains substantially stationary, and in
effect serves as a guide for the tube 2 as it is inserted. When the needle
1 and tube 2 are in the relative positions depicted in FIG. 3, the
proximal end of the needle 1, including the handle 3, will be projected
outwardly above the proximal end of the tube 2, as can be more clearly
seen in FIG. 1. Moreover, the distal cutting edge 7 will project into the
body tissue 9 outwardly of the cutting point 6 of needle 1, as depicted in
FIGS. 1 and 3.
With reference now to FIG. 4, the withdrawal operation of the device will
now be described. The tube 2 and needle 1 are withdrawn substantially
simultaneously from the position shown in FIG. 3 to that shown in FIG. 4
in the direction of the arrow depicted in FIG. 4. In this connection, it
should be noted that as the tube 2 and needle 1 are withdrawn from the
patient's body no rotational movement is required. As the tube 2 and
needle 1 are withdrawn, the tissue specimen will be collected interiorly
of the tube 2 between the slight space provided between the inside diamter
of the tube 2 and the needle 1. The major portion of the specimen will be
effectively contained between adjacent thread portions of the sharp
helical thread 4, and in this manner a fairly large and entirely adequate
specimen size can be collected and extracted from the patient's body, with
minimal pain or trauma to the patient.
Referring now to FIG. 5, an enlarged view of the obtained specimen is
depicted. It can be seen that the specimen is collected in the slight
space present between the inside diameter of the tube 2 and the needle 1.
The thread 4 substantially aids in collecting and retaining the specimen
to be extracted. Thus, the helical thread 4 serves two important
functions. First, upon insertion of the needle 1 into the patient's body
as described hereinabove, the sharp thread 4 serves to cut the skin and
tissue during the rotational movement of the needle 1 to facilitate
penetration thereof into the patient's body. Secondly, upon withdrawal of
the needle 1 within the tube 2, the thread 4 functions to collect and
retain the specimen sample being extracted.
After the device, with the specimen contained therein, has been fully
withdrawn from the patient's body, the device may again be separated and
the specimen simply and effectively removed therefrom with the use of
suitable tools.
It should be noted that the needle 1 and tube 2 may be constructed of
standard materials commonly used in the manufacture of surgical
instruments. For example, stainless steel, polyurethane, or other suitable
surgical material may be employed.
Although there have been described what are at present considered to be the
preferred embodiments of the invention, it will be understood that various
modifications may be made therein, and it is intended to cover in the
appended claims all such modifications as fall within the true spirit and
scope of the invention.
* * * * *
|
|
 |
|
 |
Description |
|
