U.S. patent number 3,630,192 [Application Number 04/841,276] was granted by the patent office on 1971-12-28 for instrument for internal organ biopsy.
Invention is credited to Khosrow Jamshidi.
United States Patent |
3,630,192 |
Jamshidi |
December 28, 1971 |
INSTRUMENT FOR INTERNAL ORGAN BIOPSY
Abstract
Biopsy needle means particularly adapted for the withdrawal of
tissue through a cannula forced through or along an unnatural route
into the interior of a live body or organ such as thyroid, spleen,
or a tumor mass, the means comprising, in combination, a biopsy
needle including a generally hollow axially flexible elongated
needle having a generally uniform cylindrical configuration with an
internal core of substantially constant internal diameter extending
throughout the major portion of the axial length of the needle,
said needle having a tapered distal tip with a cutting surface
formed along the edges of the tip, the needle having substantial
axial flexure, stylet means having an external configuration
generally matching the configuration of said core and arranged to
be received within the core of said hollow needle, the stylet means
comprising a rigid shaft having a closed sharp tip arranged to
extend distally from the tapered distal tip when the stylet is
received within the core of the hollow needle. In addition, the
biopsy needle means is provided with a sheath which has substantial
axial flexure for accommodating relative motion of various organs
within the body, and reducing or eliminating the occurrences of
bleeding complications.
Inventors: |
Jamshidi; Khosrow (Minneapolis,
MN) |
Family
ID: |
25284467 |
Appl.
No.: |
04/841,276 |
Filed: |
July 14, 1969 |
Current U.S.
Class: |
600/567; 219/230;
606/21; 606/29; 219/229; 604/172; 606/23 |
Current CPC
Class: |
A61B
10/025 (20130101) |
Current International
Class: |
A61B
10/00 (20060101); A61b 010/00 (); A61b
017/36 () |
Field of
Search: |
;128/2,2B,303.1,303.13,303.17,303.14,347,310,305 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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|
|
|
|
135,689 |
|
May 1952 |
|
SW |
|
142,879 |
|
Nov 1953 |
|
SW |
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171,975 |
|
Nov 1965 |
|
SU |
|
Other References
The Lancet, March 13, 1965, p. 585..
|
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Howell; Kyle L.
Claims
What is claimed is:
1. An elongate hollow biopsy needle having opened distal and
proximal ends, said distal end defining a cutting edge,
a. said needle having substantial axial flexure and being of
uniform hollow cylindrical configuration throughout the major
portion of its length, and having an external distal end surface
portion tapered generally uniformly uninterrupted toward the tip of
the distal end, and an internal end surface portion tapering
generally uniformly, uninterrupted, toward the tip of the distal
end defining an inner biopsy tissue receiving and retaining bore
immediately adjacent the distal end and with the needle converging
from a first circular diameter which extends along the major
portion of the length of the needle toward and to second and
significantly smaller circular diameter at the distal end, a rigid
elongate stylet having substantially less axial flexure than said
needle and being positioned within said needle and corresponding
generally in length and shape to the bore formed in said needle,
said stylet being of uniformly cylindrical configuration throughout
a major portion of its length, and having a uniformly uninterrupted
tapered distal end portion converging to a closed distal end
tip;
b. means arranged on said needle and stylet to position the stylet
within said needle so that the distal ends of the generally
flexible needle and rigid stylet cooperate with each other to
present a symmetrical closed tip end whereby said needle and stylet
may be inserted as a unit into a tissue, and when said stylet is
removed from the needle after insertion into a tissue, and upon
manipulation of the needle, the distal cutting end of the generally
flexible needle will cut a tissue sample and the tissue sample will
be collected in the expanded distal end portion of the bore of the
needle to thereby minimize damage to the tissue.
2. The biopsy needle means as defined in claim 1 being particularly
characterized in that sheath means are provided, coupled to said
needle and disposed about the outer surface of said needle, said
sheath means having a central bore therein for receiving, in
coaxial disposition therewithin, said biopsy needle and stylet
means, said sheath being formed from axially flexible material with
flexural characteristics substantially matching the flexural
characteristics of said needle.
3. The biopsy needle means as defined in claim 2 being particularly
characterized in that guard means are provided for releasably
locking engagement with the surface of said sheath.
4. The biopsy needle means as defined in claim 2 being particularly
characterized in that the bore of said sheath is adapted to receive
microcauter means, and microcauter means are received within said
sheath, said microcauter means including a cauterizing tip which
extends axially outwardly beyond the distal end of said sheath.
5. The biopsy needle means as defined in claim 2 being particularly
characterized in that the bore of said sheath is adapted to receive
cryoprobe means, and cryoprobe means are received within said
sheath, said cryoprobe means including a freezing tip which extends
axially outwardly beyond the distal end of said sheath.
6. The biopsy needle means as defined in claim 1 being particularly
characterized in that guard means are provided for lockingly
engaging the surface of said needle.
7. The biopsy needle means as defined in claim 1 being particularly
characterized in that the proximal end of said needle is provided
with means adapted for releasably locking engagement with a powered
source of rotational energy.
8. The biopsy needle device as defined in claim 1 being
particularly characterized in that said needle is fabricated from
stainless steel filaments woven together to form a tubular needle
structure.
9. The biopsy needle device as defined in claim 1 being
particularly characterized in that said needle is fabricated from
molded silicone.
10. The biopsy needle device as defined in claim 1 being
particularly characterized in that said needle is fabricated from
molded polytetrafluoroethylene.
Description
The present invention relates to an improved biopsy needle means,
and more particularly to a biopsy needle stylet-sheath means which
is particularly adapted for use in the obtaining of biopsy samples
from certain floating organs or the like such as, for example,
thyroid, spleen or a tumor mass. Frequently, during the performance
of biopsies, biopsy needle means are generally inserted through a
cannula formed by forcing the needle means along or through an
unnatural route into the interior of the patient's body. If
relative motion occurs along the cannula while the needle is
present, the soft tissue organs such as thyroid, spleen, or tumor
mass may suffer bleeding complications.
Biopsies may be taken by a number of procedures, including, for
example, open surgery or percutaneous biopsy techniques. On certain
occasion, however, percutaneous biopsies of organs such as thyroid,
spleen, or tumor mass may be avoided and resort will be had to
operative surgical procedures which, as indicated are generally
more time consuming, require greater surgical skill, and may
require the performance of major surgical steps. When it is desired
to reveal the pathology of certain other organs such as liver,
kidney and lungs through the simple percutaneous biopsy techniques,
the occurrence of certain bleeding disorders in such patients
render the percutaneous biopsy of such organs with presently
available needles either impossible or dangerous due to the fear of
bleeding complications. Also, if percutaneous procedures are
utilized for obtaining biopsies from lungs, liver, kidney and
spleen, these procedures must be taken rapidly, since these organs
tend to move relative to other parts of the body due to respiration
or other movements of the patient, and there may accordingly be
danger of laceration and bleeding unless the biopsies are taken
within the limited time and tolerance of the patient for avoiding
respiration and holding their breath. Also, it may be important in
certain patients to be able to obtain adequate biopsy material
without bringing about structural damage of the tissue obtained
from within the patient's body, which, if damaged, may make proper
examination and diagnosis difficult to achieve. On other occasions,
it may be desirable to aspirate tissue or blood samples from an
organ aside from taking a biopsy through a single procedure.
The biopsy needle means of the present invention may be fabricated
from flexible material of variable length and caliber, the length
and caliber being determined by the specific end need of the
device. The distal end is beveled or tapered, and the beveled edge
is sharpened in order to facilitate cutting into the organs
pertinent to the biopsy. The interior of the needle is hollow, and
the distal end of the hollow core is also tapered gradually with
increasing caliber toward the proximal end of the needle in order
to render it possible to obtain adequate material for purposes of
the biopsy. This tapering structure prevents crushing of the tissue
material, and accordingly eliminates the tendency toward structural
damage of the tissues lodged in the needle due to the taper. The
tissue material as recovered in the distal end of the needle is
also entrapped and thus resistant to escape from the distal end of
the needle as the needle is being pulled out. The features of the
tapered distal end are disclosed in detail in my copending
application Ser. No. 803,199, filed Feb. 28, 1969, and entitled
"Biopsy Needle."
The sheath is also made of flexible material, thus accommodating
the use of the device in nonfixed movable organs. The sheath is
made so as to exactly fit the outer surface of the biopsy needle
device to a point slightly below the beveled tip of the biopsy
needle. The proximal end of the sheath may be modified, as desired
to fit a syringe for aspiration purposes of the organs involved.
The structure further includes a stylet which is made of hard
material such as stainless steel or the like so as to fit within
the biopsy needle with a sharp tip to extend beyond the beveled tip
of the needle approximately 1 to 2 millimeters as desired.
If desired, a probe of hard material such as stainless steel as is
conventional, may be utilized to remove the biopsy material from
the interior core of the needle the probe being introduced from the
distal end.
The apparatus of the present invention is further particularly
adaptable for use with a microcauter, the microcauter being made of
flexible heat or cold resistant material. Means are provided for
coupling the microcauter to a source of electrical current,
although batteries may be utilized to supply power, if required.
The microcauter is fabricated so as to fit within the biopsy sheath
with the tip extending a few millimeters beyond the distal end of
the sheath. As an alternative, a cryoprobe may be utilized in lieu
of the microcauter. The cryoprobe is preferably made of flexible
metal and is adapted to fit within the sheath with its tip
extending a few millimeters beyond the distal end of the sheath. It
is provided with means for coupling to a source of extreme low
temperature material such as, for example, liquid nitrogen or the
like.
If desired, a guard may be utilized for accommodating a measured
insertion depth for the biopsy structure, a suitable set screw
means or the like being provided to accomplish the setting at a
predetermined distance from the tip of the needle. This will be
accomplish penetration of the organ desired.
Therefore, it is an object of the present invention to provide an
improved biopsy needle means which provides an axially flexible
needle means with an axially flexible sheath, the apparatus being
particularly adapted for use in the taking of biopsies from
relatively soft or movable organs.
It is a further object of the present invention to provide an
improved biopsy needle means which permits the taking of biopsies
from a plurality of organs, including floating or relatively
movable organs, the system being particularly adapted to the taking
of percutaneous biopsies.
Other and further objects of the present invention will become
apparent to those skilled in the art upon a study of the following
specification, appended claims, and accompanying drawings
wherein:
FIG. 1 is an elevational view of the biopsy needle means fabricated
in accordance with the present invention, and illustrating the
sheath, needle, stylet, and guard in proper operating
disposition;
FIG. 2 is a detail elevational view of the needle portion of the
apparatus shown in FIG. 1;
FIG. 3 is a detail elevational view of the sheath portion of the
apparatus, this figure illustrating a modified form of proximal
end;
FIG. 4 is a detail elevational view of the stylet portion of the
apparatus shown in FIG. 1;
FIG. 5 is a detail view of a probe which may be utilized to remove
material from the core of the needle illustrated in FIG. 2;
FIG. 6 is a detail elevational view of a microcauter apparatus
which may be utilized in connection with the sheath means shown in
FIGS. 1 and 3;
FIG. 7 is a detail elevational view of a cryoprobe which may be
utilized in combination with the sheath means shown in FIGS. 1 and
3;
FIG. 7A is a detail view, on an enlarged scale, showing a broken
away segment of the shaft of the cryoprobe of FIG. 7; and
FIG. 8 is a detail elevational view of a sheath having a modified
proximal end, such as is shown in the apparatus of FIG. 1.
In accordance with the preferred modification of the present
invention, and particularly as is illustrated in FIG. 1, the biopsy
needle means of the present invention generally designated 10
includes an outer sheath manner 11, the sheath retaining coaxially
therewithin, the biopsy needle 12, along with the interiorly
disposed stylet 13. Also, on the outer surface of the sheath 11,
there is received a guard member 14 which is secured firmly to a
sleeve 15, sleeve 15 being axially slidable along the extent of the
sheath 11 and arranged to be secured in place by means of locking
screw 16.
Turning now to the detail of the needle portion 12, it will be seen
that the needle 12 comprises a generally hollow sleeve member 20
having a distal end portion 21 and a proximal end 22. The distal
end is gradually tapered at the tip end thereof, for approximately
2 to 3 centimeters in order to accommodate cutting into the organs
involved. Also, the beveled edge is made quire sharp in order to
facilitate cutting into the organs involved. The inner core of the
needle is also tapered at the distal end in order to accommodate
material that is gathered in the course of the biopsy, and permit
this material to be lodged with ease into the inner core of the
needle. This structural feature is, as previously indicated,
disclosed in detail in my copending patent application referred to
hereinabove.
In order to provide the degree of flexibility required, the needle
is fabricated from a flexible metal, such as, for example, a woven
group of filament such as, for example, stainless steel or the
like. In some situations, molded plastic resin materials such as,
for example, molded silicone, molded polytetrafluoroethylene, or
the like may be utilized.
The needle is normally encased within a sheath means such as is
illustrated in FIG. 1, a modified form of sheath being shown in
FIG. 3 at 30. The sheath is in the form of a hollow shaft, and has
a tapered distal end as at 31 terminating in a needle-accommodating
tip 32. If desired, a modified form of sheath such as is
illustrated in FIG. 8 may be employed, as will be more fully
discussed hereinafter.
The sheath means, when employed, is preferably flexible and is
resistant to temperatures encountered during use. For example, the
material, if sued in combination with the microcauter illustrated
in FIG. 6, the structure should be capable of withstanding the
temperatures to which it is exposed. The same situation is, of
course, appropriate for use with the cryoprobe disclosed in FIG. 7.
In most instances, the sheath may be fabricated from the same
materials discussed in connection with the needle portion of the
device disclosed in FIG. 2.
The stylet 13, as illustrated in FIG. 4, includes a shank or shaft
portion 40 having a tissue penetrating tip 41 and a locking
proximal portion shown at 42. As is conventional, the lock, which
is the form of a bayonet lock, is utilized to firmly secure and
adhere the stylet to the needle member 20. The channels illustrated
in the locking head portion 22 will, of course, accommodate the
locking pins illustrated at 43 in FIG. 4.
It will be appreciated that the stylet should be fabricated from a
hard material such as stainless steel or the like, and is provided
with a structure for fitting exactly within the tip of the needle,
the sharp tip of the stylet extending beyond the beveled tip of the
needle approximately 1 to 2 millimeters. If desired, as an
alternative, the tip portion of the stylet may be in the form of an
auger screw in order to penetrate hard material.
Reference is now made to FIG. 5 wherein a probe is illustrated at
50, this probe being adapted to be inserted within the tip portion
21 of the needle and used to urge or drive any retained material
axially outwardly through the proximal end of the needle 12. The
length of the probe exceeds the length of the biopsy needle by a
few centimeters and preferably is provided with a blunt tip.
Attention is now directed to FIG. 6 of the drawings wherein a
microcauter is illustrated, the microcauter 60 including a body
portion 61 along with a tip member 62 which extends a few
millimeters beyond the distal end of the sheath, when in place. The
microcauter further includes a means for coupling to a source of
electrical current or power, such as at 63, the electrical power
being utilized to heat the tip 62 to a suitable cauterizing
temperature.
Attention is now directed to FIG. 7, wherein the cryoprobe
generally designated 70 having a body portion or shank 71 and a tip
member 72. Means are provided as at 73 for coupling the cryoprobe
to a suitable source of cryogenic materials, such as, for example,
liquid nitrogen or the like. With liquid nitrogen being held at
equilibrium with gaseous nitrogen in ambient conditions, the liquid
nitrogen cools to cryogenic temperatures, and this material may be
circulated through the interior of the cryoprobe, particularly
through the supply and return conduits 74 and 75, these conduits
being thin-walled metallic members capable of accommodating a flow
of cryogenic material such as liquid nitrogen or the like held at
cryogenic temperatures. The tip of the cryoprobe such as is shown
at 72 is utilized to accommodate the flow from the conduits 74 and
75, and is preferably thermally conductive so as to accept the low
temperature of the cryoprobe member.
Attention is now directed to FIG. 8 wherein a modified form of
sheath is provided, this sheath including the modified proximal end
81 which may be employed to accept a syringe or the like for
aspirating an organ which is involved in the biopsy.
In order to take a biopsy from a potentially bleeding organ that is
fixed within the body of the patient, the biopsy needle structure
as illustrated in FIG. 1 is employed, the guard 14 being locked
onto the surface of the sheath at the desired location. The needle
means is then introduced into the body of the patient and the
needle tip is brought into proximity to the pertinent organ. The
stylet 13 is then removed and the guard is readjusted to the length
of the needle needed to penetrate into the organ involved, at which
time the needle is introduced into the organ either by using a
stabbing push or by using a source of rotational energy or motion
derived from an electric drill, for example, coupled or interlocked
to the proximal end of the needle. If desired, the needle may be
introduced into the organ by utilizing an auger tip on a stylet, if
indicated. After the needle has been introduced into the organ to a
length determined by the second locking position of the guard, the
needle is removed from the sheath, leaving the sheath behind in the
organ. The biopsy needle containing the biopsy material is then set
aside. Thereafter, either the microcauter illustrated in FIG. 6 or
the cryoprobe illustrated in FIG. 7 is introduced into the sheath.
At this time, the source of electrical power is applied in order to
cause the tip of the microcauter to achieve cauterizing
temperature, or, if the cryoprobe is utilized, a source of
cryogenic material is introduced into the structure to cool the tip
of the cryoprobe. At this point, the sheath with the already
secured microcauter or cryoprobe is slowly removed from the organ
so that cauterization or cooling of the biopsy tract is secured,
thus preventing the organ from internal hemorrhaging or bleeding.
The biopsy material already lodged in the tip of the needle is then
removed with the probe 50, and processed for the appropriate
determinations or studies.
In order to utilize the structure of the present invention for the
purpose of taking biopsy from an organ that is potentially a
bleeder and is nonfixed or moves with respiration of the patient,
such as spleen or the like, the procedure is similar to that
disclosed hereinabove, except that the needle is inserted into the
organ and thereafter immediately removed leaving the flexible
sheath behind. Since the sheath is reasonably flexible, it will
bend according to the movement of the organ involved and will not
cause damage to occur. The biopsy tract is similarly cauterized or
frozen using the flexible microcauter or flexible cyroprobe.
In performing the cauterizing or freezing of the biopsy tract,
particularly when potentially movable organs are involved, it is
important that the shaft portions of the microcauter and cryoprobe
be flexible in order to accommodate this relative motion.
In order to take a biopsy from an organ that may move and is not
potentially a bleeder, the speed for taking the material is of
primary importance. In this instance, the axially flexible biopsy
needle is utilized without the sheath, with the stylet and guard in
proper disposition. The needle together with the stylet is then
introduced into the skin and brought into the proximity of the
organ involved. The stylet is then removed from the needle and the
needle is then prepared for advancement or introduction into the
organ. If desired, a rotating drill may be utilized to cause
rotation of the needle as it is being introduced into the organ,
where appropriate. At any rate, the stylet is removed and if
rotational energy is utilized, it is accomplished with a stabbing
push to introduce the needle into the organ to the desired length
which is determined or defined by the position of the guard, and
then the needle is immediately withdrawn with the obtaining of the
predetermined quantity of biopsy material. For obtaining the
rotational energy, a drill head may be utilized which is lockingly
engaged to the locking lugs which are present at the proximal end
of the needle portion of the apparatus as shown in FIG. 2. The
drill has a rotational velocity capability in the area of about
3,600 r.p.m., and may be powered by conventional electrical current
means, or by a suitable source of battery power. This procedure
normally will not require more than a few seconds and can be
accomplished without difficulty.
It has been indicated that the needle is generally flexible, and
this of course is preferred. However, in order to facilitate and
improve the insertion characteristics of the needle, the tip end
may be fabricated from a sharpened metal such as, for example,
stainless steel or the like. This tip may be molded in situ with
the needle proper.
In order to aspirate tissue of blood from an organ, the needle is
introduced into the organ to the extent desired, and when adequate
biopsy material has been obtained, a syringe is attached to the
modified sheath such as is illustrated in FIG. 8, and the biopsy
material is then aspirated through the syringe. If the organ
involved is potentially a bleeder, then the biopsy tract is
counterized or frozen as described hereinabove.
It will be appreciated that the structural details illustrated
herein are illustrative of various embodiments which may be
fabricated by those skilled in the art.
* * * * *