U.S. patent application number 14/248902 was filed with the patent office on 2014-08-07 for biopsy needle system and method for obtaining a tissue biopsy specimen.
The applicant listed for this patent is W. THOMAS MC CLELLAN. Invention is credited to W. THOMAS MC CLELLAN.
Application Number | 20140221870 14/248902 |
Document ID | / |
Family ID | 38475364 |
Filed Date | 2014-08-07 |
United States Patent
Application |
20140221870 |
Kind Code |
A1 |
MC CLELLAN; W. THOMAS |
August 7, 2014 |
BIOPSY NEEDLE SYSTEM AND METHOD FOR OBTAINING A TISSUE BIOPSY
SPECIMEN
Abstract
A biopsy needle system includes a carrier. A trocar is inserted
into the carrier for percutaneous insertion to a biopsy site. A
biopsy needle is inserted into the carrier, replacing the trocar,
for removal of a tissue biopsy specimen. A biopsy needle and a
method for obtaining a tissue biopsy specimen with the system, are
also provided.
Inventors: |
MC CLELLAN; W. THOMAS; (Fort
Lauderdale, FL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
MC CLELLAN; W. THOMAS |
Fort Lauderdale |
FL |
US |
|
|
Family ID: |
38475364 |
Appl. No.: |
14/248902 |
Filed: |
April 9, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13469751 |
May 11, 2012 |
8728006 |
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14248902 |
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13469742 |
May 11, 2012 |
8728005 |
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13469751 |
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11361422 |
Feb 24, 2006 |
8187203 |
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13469742 |
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Current U.S.
Class: |
600/566 ;
600/567 |
Current CPC
Class: |
A61B 2090/034 20160201;
A61B 2090/062 20160201; A61B 2017/32004 20130101; A61B 10/0266
20130101; A61B 10/0275 20130101; A61B 17/3403 20130101; A61B
10/0283 20130101 |
Class at
Publication: |
600/566 ;
600/567 |
International
Class: |
A61B 10/02 20060101
A61B010/02 |
Claims
1. A biopsy needle system, comprising: a carrier; a trocar to be
inserted into said carrier for percutaneous insertion to a biopsy
site; a biopsy needle to be inserted into said carrier, replacing
said trocar, for removal of a tissue biopsy specimen; a syringe
including a connector configured to mate with a connector of said
biopsy needle, after insertion of said biopsy needle into said
carrier, for applying a vacuum to assist in tissue migration into
said biopsy needle, said syringe including a body and a plunger;
and said body of said syringe including a lip around a top of said
body and said plunger including at least one angled notch
configured to engage and lock with said lip when said plunger is
moved off center in said body.
2. The biopsy needle system of claim 1, wherein said plunger
includes a plurality of angled notches configured to engage and
lock with said lip.
3. The biopsy needle system of claim 2, wherein said lip is an
upwardly-angled lip and said plurality of angled notches are
downwardly-angled notches.
4. A method for obtaining a tissue biopsy specimen, the method
which comprises the following steps: providing a biopsy system
according to claim 1; inserting the trocar into the carrier;
inserting the carrier with the trocar percutaneously to a biopsy
site; removing the trocar from the carrier; inserting the biopsy
needle into the carrier; engaging the syringe to the biopsy needle
using the connector configured to mate with a connector of the
biopsy needle, for applying a vacuum to assist in tissue migration
into the biopsy needle; applying vacuum to the lumen of the biopsy
needle with the syringe; locking the plunger relative to the body
of the syringe by moving the plunger off center in the body of the
syringe and engaging the at least one angled notch of the plunger
with the lip at the top of the body; and removing the tissue biopsy
specimen with the biopsy needle.
5. The method of claim 4, wherein the plunger includes a plurality
of angled notches configured to engage and lock with the lip.
6. The method of claim 5, wherein the lip is an upwardly-angled lip
and the plurality of angled notches are downwardly-angled
notches.
7. The method of claim 4, wherein the syringe is filled with saline
prior to connection with the biopsy needle.
8. A biopsy needle system, comprising: a carrier; a trocar to be
inserted into said carrier for percutaneous insertion to a biopsy
site; a biopsy needle to be inserted into said carrier, replacing
said trocar, for removal of a tissue biopsy specimen; and a
single-piece, biopsy depth gauge and depth controller including a
multiplicity of fitting regions configured to engage said biopsy
needle.
9. The biopsy needle system of claim 8, wherein said controller is
domino-shaped, having a long dimension and a short dimension
unequal to said long dimension, at least one of said multiplicity
of fitting regions passing through said long dimension and at least
another one of said multiplicity of fitting regions passing through
said short dimension, so that each of said at least one of said
multiplicity of fitting regions and said at least another one of
said multiplicity of fitting regions permits a different biopsy
depth.
10. The biopsy needle system of claim 9, wherein said domino-shaped
controller additionally has a medium dimension unequal to said long
dimension and said short dimension, at least a further one of said
multiplicity of fitting regions passing through said medium
dimension.
11. The biopsy needle system of claim 8, wherein said multiplicity
of fitting regions include at least one self-grasping fitted slot
configured to snap-on said biopsy needle and at least one fitted
hole sized for the biopsy needle to slide through, said at least
one fitted hole not permitting a snap-on engagement with said
biopsy needle.
12. The biopsy needle system of claim 11, wherein said controller
is domino-shaped, having a long dimension and a short dimension
unequal to said long dimension, and both of said at least one
self-grasping fitted slot and said at least one fitted hole extend
through a same one of said long dimension or said short
dimension.
13. The biopsy needle system of claim 8, wherein said controller is
domino-shaped, having a long length dimension, a medium width
dimension and a short depth dimension, and said multiplicity of
fittings is at least six fittings with at least one self-grasping
fitted slot and at least one fitted hole extending through each of
said long length dimension, said medium width dimension and said
short depth dimension.
14. A method for obtaining a tissue biopsy specimen, the method
which comprises the following steps: inserting a trocar into a
carrier; inserting the carrier with the trocar percutaneously to a
biopsy site; removing the trocar from the carrier; inserting a
biopsy needle into the carrier; providing a single-piece, biopsy
depth gauge and depth controller including a multiplicity of
fitting regions configured to engage the biopsy needle; engaging
the single-piece biopsy depth gauge and depth controller with the
biopsy needle using one of the multiplicity of fitting regions; and
removing the tissue biopsy specimen with the biopsy needle.
15. The method of claim 14, wherein the single-piece biopsy depth
gauge and depth controller is domino-shaped, having a long
dimension and a short dimension unequal to the long dimension, at
least one of the multiplicity of fitting regions passing through
the long dimension and at least another one of the multiplicity of
fitting regions passing through the short dimension, so that each
of the at least one of the multiplicity of fitting regions and the
at least another one of the multiplicity of fitting regions permits
a different biopsy depth.
16. The method of claim 15, wherein the domino-shaped controller
additionally has a medium dimension unequal to the long dimension
and the short dimension, at least a further one of the multiplicity
of fitting regions passing through the medium dimension.
17. The method of claim 14, wherein the multiplicity of fitting
regions include at least one self-grasping fitted slot configured
to snap-on the biopsy needle and at least one fitted hole sized for
the biopsy needle to slide through, the at least one fitted hole
not permitting a snap-on engagement with the biopsy needle.
18. The method of claim 17, wherein the biopsy needle is passed
through the at least one fitted hole of the single-piece biopsy
depth gauge and depth controller prior to the step of inserting the
biopsy needle into the carrier.
19. The method of claim 17, wherein the single-piece biopsy depth
gauge and depth controller is snapped-on to the biopsy needle using
the at least one self-grasping fitted slot after the step of
inserting the biopsy needle into the carrier.
20. The method of claim 17, wherein the controller is
domino-shaped, having a long dimension and a short dimension
unequal to the long dimension, and both of the at least one
self-grasping fitted slot and the at least one fitted hole extend
through a same one of the long dimension or the short
dimension.
21. The method of claim 14, wherein the controller is
domino-shaped, having a long length dimension, a medium width
dimension and a short depth dimension, and the multiplicity of
fittings is at least six fittings with at least one self-grasping
fitted slot and at least one fitted hole extending through each of
the long length dimension, the medium width dimension and the short
depth dimension.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] The present application is a divisional application of
co-pending U.S. patent application Ser. No. 13/469,751, entitled
"Method for Obtaining a Tissue Biopsy Specimen", and a continuation
of co-pending U.S. patent application Ser. No. 13/469,742, entitled
"Biopsy Needle System for Obtaining a Tissue Biopsy Specimen", both
applications filed on May 11, 2012 as divisional applications of
U.S. patent application Ser. No. 11/361,422, filed Feb. 24, 2006,
now U.S. Pat. No. 8,187,203, issued on May 29, 2012; the prior
applications being herewith incorporated by reference in their
entireties.
BACKGROUND OF THE INVENTION
Field of the Invention
[0002] The invention relates to a biopsy needle system, a biopsy
needle and a method for obtaining a tissue biopsy specimen with the
system.
[0003] The most critical diagnosis in medicine is the presence or
absence of malignancy. Although there are many screening tests:
patient awareness, physical exams, blood tests, and new imaging
systems, the hallmark of the cancer diagnosis is a physical
specimen, or biopsy, for microscopic analysis.
[0004] Malignancy is of life or death importance, so that the
quality of the biopsy is of utmost importance. Open surgical
biopsy, with total control of specimen location, size, and
condition, is the accepted standard of diagnostic quality and a
minimally invasive, percutaneous or endoscopic biopsy must not
sacrifice that quality, since a false negative may condemn the
patient to an agonizing and preventable death.
[0005] Obtaining tissue is more difficult by any remote biopsy
technique, but quality still relies on obtaining tissue of and from
the suspected mass. Therefore, location of needle placement, tissue
coring and preserving of the biopsy specimen are of critical
importance.
[0006] New imaging systems improve needle placement, but with prior
art biopsy needles, the actual capture of the biopsy specimen
remains unsure and partially blind. The complex multi-motion
sequencing of the typical side-cut biopsy needle is so demanding on
operator skill, that even automation has not made it totally
reliable.
[0007] A simple, one-motion, true end-cutting, core biopsy needle,
which cleanly and safely shear-cuts straight ahead from the initial
approach positioning, yet not blindly, would be an advancement in
the art.
[0008] Endoscopic biopsy graspers and percutaneous biopsy needles
generally recover limited, thin, short, slivers of tissue, making
microscopic analysis and diagnosis difficult. An end-cutting, core
biopsy needle, which recovers full-lumen specimens of almost
unlimited length, would be an advancement in the art.
[0009] With the prior art, the biopsied tissue is frequently
ripped, compressed, distorted or even crushed, limiting analysis
and diagnosis. Fine needle aspiration biopsy, where the tissue is
intentionally ripped into small segments or even single cell
clusters, is so destructive to intracellular and intercellular
anatomy that it is unwise to use that technique as any more than a
screening test. Their cytology debris fields are of such poor
condition, that although they can occasionally include the
diagnosis of malignancy, they seldom exclude it.
[0010] An end-cutting, core biopsy needle that is totally
non-traumatic to tissue and preserves intracellular and
intercellular anatomy would be an advancement in the art.
SUMMARY OF THE INVENTION
[0011] It is accordingly an object of the invention to provide a
biopsy needle system, a biopsy needle and a method for obtaining a
tissue biopsy specimen, which overcome the hereinafore-mentioned
disadvantages of the heretofore-known devices and methods of this
general type, which are minimally-invasive, percutaneous or
endoscopic and which not only exceed the prior art, but more
importantly match the quality of an open surgical biopsy. The
system, needle and method should be simple to use, easy to insert
and control, reliable, safe, biopsy-depth adjustable,
straight-ahead shearing, end-cutting, automatic-capture, longer
full-lumen specimen, tissue-preserving, and over all a core biopsy
needle system, a biopsy needle and a method for percutaneous and
endoscopic use that improve biopsy quality.
[0012] With the foregoing and other objects in view there is
provided, in accordance with the invention, a biopsy needle system.
The system comprises a carrier, a trocar to be inserted into the
carrier for percutaneous insertion to a biopsy site and a biopsy
needle to be inserted into the carrier, replacing the trocar, for
removal of a tissue biopsy specimen. The trocar and the biopsy
needle are longer than the carrier, permitting a distal end of the
trocar or the biopsy needle to extend beyond a distal end of the
carrier. The system uses the trocar to strengthen the carrier upon
initial insertion and relocation of the carrier and permits the
needle to be inserted at the correct location and for cutting of
the specimen only.
[0013] In accordance with another feature of the invention, the
biopsy needle has a distal end with a cross-sectional shape having
a flat side and a converging side. The converging side has a
semicircular, elliptical, oval, rounded, trapezoidal, paraboloid or
triangular shape, although other shapes are possible as well.
[0014] In accordance with a further feature of the invention, the
biopsy needle has a distal end, a lumen and a door disposed within
the lumen at the distal end. The door is moveable freely about a
hinge location from a normally open position lying at least
partially against the flat side during percutaneous insertion, to a
rotated and closed position contacting the converging side
occluding the lumen and capturing the tissue biopsy specimen. The
door has a fixed portion with a forward edge tapered and sharpened
to decrease tissue passage entrance resistance. The door has a door
tip opposite the hinge location for contacting the converging side
and occluding the lumen. The tip is tapered and sharpened on a side
facing away from the lumen and is turned down or angled toward a
center of the lumen. The tip of the door is angled into the lumen
to catch and dig into the tissue biopsy specimen upon retraction of
the biopsy needle. Thus, an automatic door for catching and
removing a tissue biopsy specimen is provided, which requires no
other operation or manipulation other than advancement and
retraction.
[0015] In accordance with an added feature of the invention, the
biopsy needle has a distal end with a tissue cutting entrance,
which is preferably angled relative to a longitudinal axis of the
biopsy needle. The tissue cutting entrance advances into the tissue
biopsy specimen permitting the core to contact the door.
[0016] In accordance with an additional feature of the invention,
there is provided a hinge interconnecting the flat side and the
door at the hinge location. The hinge may be an articulating hinge,
a tension-compression or live one-piece functional hinge, or a
torsion element live or one-piece functional hinge. The hinge
permits the door to swing away ahead of the specimen core and close
behind it to obtain a tissue biopsy specimen.
[0017] In accordance with yet another feature of the invention, the
door has at least one and preferably two flexing areas functioning
as a hinge, which may be formed by cutting into the door, in
particular in a pattern of separation lines. The flexing areas
preferably each extend perpendicularly to the longitudinal
direction of the door. This provides great flexibility of the door
without an articulating hinge.
[0018] In accordance with yet a further feature of the invention,
the door tip is angled into the lumen at one of the flexing areas
closest to the door tip and is tapered and sharpened on a side
facing away from the lumen, to catch and dig into the tissue biopsy
specimen upon retraction of the biopsy needle.
[0019] In accordance with yet an added feature of the invention,
the trocar has a tapered point protruding from the carrier.
[0020] In accordance with yet an additional feature of the
invention, the trocar and the carrier have distal ends with
cross-sectional shapes matching the cross-sectional shape of the
biopsy needle. The most suitable of the above-mentioned
cross-sectional shapes can be used for all three devices, the
trocar, the carrier and the biopsy needle.
[0021] In accordance with again another feature of the invention,
the carrier, the biopsy needle and the trocar each have at least
one control ring. The carrier has a proximal end with a conically
shaped or tapered entrance facilitating introduction of the biopsy
needle and the trocar into the carrier. The control rings and the
conical or tapered entrance facilitate operation and manipulation
by an operator.
[0022] In accordance with again a further feature of the invention,
the carrier has an outer surface with etched markings of insertion
length. The markings aid in percutaneous insertion placement.
[0023] In accordance with again an added feature of the invention,
there is provided a controller to be fitted on the biopsy needle,
after insertion of the biopsy needle into the carrier, for
adjustably gauging biopsy depth. The controller has a multiplicity
of fitting regions each permitting a different biopsy depth. The
controller is block-shaped and the fitting regions are slots or
holes formed in the block-shaped controller having different
lengths. The controller provides a simple way of adjusting cutting
depth, with the longest depth being without use of the controller
and decreasing depths being provided through use of the different
fitting regions.
[0024] In accordance with again an additional feature of the
invention, there is provided a syringe to be locked to the biopsy
needle, after insertion of the biopsy needle into the carrier, for
applying a vacuum to assist in tissue migration into the biopsy
needle. The biopsy needle has a syringe connector, and the syringe
has an end matching the syringe connector. The syringe connector
and the end of the syringe are tapered conically. The syringe has a
syringe plunger to be pulled out and locked for applying the
vacuum. The syringe has a syringe body with a lip or peak, and the
plunger has notches to be locked on the lip or peak. The syringe
may be preloaded with a fluid, such as saline, to fill the biopsy
needle while evacuating air and facilitate formation of a vacuum
seal upon insertion of the biopsy needle and extraction of the
tissue biopsy specimen. The vacuum syringe aids in extraction of
the specimen and allows the specimen to be removed without being
disturbed by manual manipulation of the operator.
[0025] With the objects of the invention in view, there is also
provided a biopsy needle. The biopsy needle comprises a lumen, and
a door disposed at the lumen. The door is moveable freely about a
hinge location from a normally open position during percutaneous
insertion, to a rotated and closed position occluding the lumen and
capturing a tissue biopsy specimen for removal. All of the features
of the biopsy needle of the biopsy needle system can be used in the
biopsy needle apart from the other features of the system. For
example, the cross-sectional shapes, the tapered and sharpened
forward edge and tip of the door, the tissue cutting entrance, the
hinges and the flexing areas may all be used as well.
[0026] With the objects of the invention in view, there is
additionally provided a method for obtaining a tissue biopsy
specimen. The method comprises inserting a trocar into a carrier,
inserting the carrier with the trocar percutaneously to a biopsy
site, removing the trocar from the carrier, inserting a biopsy
needle into the carrier, and removing the tissue biopsy specimen
with the biopsy needle. This method is simple to use, accurate and
obtains a quality specimen. The rotation of the door, the decrease
in tissue passage entrance resistance with a tapered and sharpened
forward edge of the door, the flexing of the door, the catching and
digging into the tissue biopsy specimen with the door tip and the
movement of the door within the cross-sectional shapes, are all
part of the method of the invention.
[0027] Other features which are considered as characteristic for
the invention are set forth in the appended claims.
[0028] Although the invention is illustrated and described herein
as embodied in a biopsy needle system, a biopsy needle and a method
for obtaining a tissue biopsy specimen, it is nevertheless not
intended to be limited to the details shown, since various
modifications and structural changes may be made therein without
departing from the spirit of the invention and within the scope and
range of equivalents of the claims.
[0029] The construction and method of operation of the invention,
however, together with additional objects and advantages thereof
will be best understood from the following description of specific
embodiments when read in connection with the accompanying
drawings.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING
[0030] FIG. 1 is a diagrammatic, partially elevational and
partially perspective view of a biopsy needle system according to
the invention;
[0031] FIG. 2 is a side-elevational view of a biopsy needle of the
system according to the invention;
[0032] FIG. 3 is a side-elevational view of a trocar of the system
according to the invention;
[0033] FIG. 4 is a side-elevational view of a carrier of the system
according to the invention;
[0034] FIG. 5 is a side-elevational view of the biopsy needle
inserted into the carrier;
[0035] FIG. 6 is a side-elevational view of the trocar inserted
into the carrier;
[0036] FIG. 7 is a side-elevational view of the biopsy needle
inserted into the carrier, with a depth controller
therebetween;
[0037] FIG. 8A is a perspective view of the trocar inserted into
the carrier;
[0038] FIG. 8B is a perspective view of the biopsy needle inserted
into the carrier;
[0039] FIG. 9 is a fragmentary, greatly enlarged, cross-sectional
view of a distal end of the biopsy needle with a rotating door in
an open position;
[0040] FIG. 10 is a view similar to FIG. 9 with the rotating door
in a closed position;
[0041] FIGS. 11A-11E are end-elevational views of the distal end of
the biopsy needle showing different cross-sectional shapes;
[0042] FIG. 12 is a further enlarged, front-elevational view of the
rotating door with a flexing area;
[0043] FIGS. 13 and 14 are views similar to FIG. 12 of the rotating
door with two flexing areas;
[0044] FIGS. 15 and 16 are perspective views of the rotating door
with two flexing areas in different flexing positions;
[0045] FIGS. 17A and 18A are respective perspective and
side-elevational views of the rotating door having an articulating
hinge in a non-rotated position;
[0046] FIGS. 17B and 18B are respective perspective and
side-elevational views of the rotating door having the articulating
hinge in a rotated position;
[0047] FIGS. 19A and 19B are enlarged, perspective views of a
controller of the system according to the invention;
[0048] FIGS. 20A, 20B and 20C are enlarged, perspective views
showing a syringe of the system according to the invention in three
positions with and without the biopsy needle; and
[0049] FIGS. 21A and 21 B are side-elevational views of the
assembled carrier, controller, biopsy needle and syringe, in two
different positions of the controller.
DETAILED DESCRIPTION OF THE INVENTION
[0050] Referring now to the figures of the drawings in detail and
first, particularly, to FIG. 1 thereof, there is seen a biopsy
needle system according to the invention which has a biopsy needle
1, a trocar 40, a carrier 50, a controller 60 and a syringe 70.
More specifically, the five-piece system includes: [0051] a. an
integrated, reliable, true end-cutting, full-lumen specimen,
coring, biopsy needle 1; [0052] b. an integrated, easy-insertion,
biopsy needle carrier trocar 40; [0053] c. an integrated,
improved-placement, high-reflectance, easy-insertion, biopsy needle
carrier 50; [0054] d. an integrated, single-piece, dual-use,
adjustable biopsy depth gauge and depth controller 60; and [0055]
e. an integrated, dual-use, lockable, vacuum-assisted, coring and
non-traumatic specimen removal syringe 70.
[0056] As is seen in FIG. 2, the biopsy needle 1 is formed as a
tube-like structure, constructed of metal or other suitable
material with a proximal end 2 (at the left in the figure) toward
the operator and a distal end 3 (at the right in the figure) toward
the object tissue. The proximal end 2 has a permanently attached
control ring 4 for operator control, mounted over a tapered
reinforcing collar 5, which also includes an inline, full size
lumen-matching syringe connector 6 continuous with the needle
lumen. The lumen is defined as all of the space or the passage or
channel within a tube. The distal end 3 has a sharpened double
angled, shear cutting edge tissue entrance 7, formed or angled at
approximately 45 degrees from a centerline or longitudinal axis 15
and is constructed for an improved straightforward, non-blind, core
cutting and capture of a tissue biopsy. This structure of angled
cutting surfaces creates a shearing edge, as opposed to a right
angle or straight across edge, which has increased cutting
resistance and crushes tissues of very firm or soft consistencies.
The distal end 3 with the tissue entrance 7 will be described in
more detail below with regard to FIGS. 9 and 10.
[0057] As is seen in FIGS. 11A-11E, the tissue entrance 7 of the
biopsy needle 1 is constructed with unique cross-sectional shapes.
These shapes all have one flat side or section 8 covering of
approximately one third of the circumference of the tissue entrance
7 and opposing walls covering approximately two thirds of the
remaining circumference and having symmetrical, constantly closing
angle wall configurations from the flat side 8, to close the tube
or needle 1.
[0058] These opposing walls of the structural shapes, which are
important to the invention, include a converging side 9 forming a
semicircle in FIG. 11A, converging sides 10 forming an ellipse or
oval in FIG. 11B, converging sides 11 forming a pure or rounded
trapezoid in FIG. 11C, converging sides 12 forming a paraboloid in
FIG. 11D, and symmetrical converging straight sides 13 forming a
triangular shaped tube or needle in FIG. 11E.
[0059] Each of these shapes and similar ones with converging walls
are used in the invention depending on needle type, intended use,
length, size, operator preference, tissue type and tissue
consistency. As will be explained below with regard to a door 20 of
the invention, the converging wall shapes shown in FIGS. 11A-11E
allow for continuous and simultaneous door to lumen wall occlusion,
door rotation stoppage, complete tissue severing, uniform door edge
support and reliable specimen capture.
[0060] The straight or flat side 8 provides a flat area for
permanent attachment of a fixed half of a hinge to the rotating
hinged door 20. This end-cutting door 20, which is located just
inside the distal tissue entrance 7, as is seen in FIGS. 9 and 10,
is the part of the invention which allows for automatic end cutting
of the needle biopsy core specimen.
[0061] A fixed or nonmoving portion 21 of the door 20 has a forward
(lumen side) edge 22 which is tapered and sharpened to decrease
tissue passage entrance resistance. The hinged door 20 moves freely
about a hinge location 23 from its normally open position shown in
FIG. 9 in which it lies against the straight wall or flat wall
segment 8 during insertion, to an opposite extreme of being fully
rotated and closed against the opposing wall or converging side
9-13 as is seen in FIG. 10, totally occluding the passageway or
lumen 14 and capturing the biopsy tissue.
[0062] The hinged door 20 and the converging walls or sides 9-13
work in combination to form and function as the long sought after,
true end-cutting biopsy needle. The constantly converging walls or
sides 9-13 form a continuous and simultaneous shearing occlusion
between the lumen 14 and the lumen-shaped door 20. This hinged door
20 is contoured to fit the lumen 14 perfectly at about a 35 to 45
degree arc segment of the needle lumen or on a line running
approximately 35 to 45 degrees from a centerline of the lumen, as
is seen in FIG. 10. The distal end 3 of the needle tube is formed
at approximately a 40 to 50 degrees angle and the hinged door 20
stops or occludes at roughly 5 to 15 degrees of rotation short of
the end of the needle. The door 20 intentionally impacts the
opposing or converging lumen walls or sides 9-13 uniformly and is
supported along the entire circumference, stopping and shearing,
without any other operator action, mechanical parts or latches.
Further door rotation or pass through failure is prevented.
[0063] This structure according to the invention has been developed
because it has been found that with non-converging angle walls,
such as with a square tube, there is no uniform contact or
shearing, the door is unevenly supported, being held only at the
hinge and opposite wall. The door flexes centrally, shortens, and
over rotates, with pass through door failure and tissue specimen
loss.
[0064] Three separate embodiments of hinge structures may used in
the end-cutting door 20 according to the invention, depending on
needle size, length, intended use, operator preference, tissue type
and tissue consistency.
[0065] First is a macro-machined or formed, common articulating
hinge 47 provided at the hinge location 23, where two or more
pieces rotate 48, 49 in relation to each other at, around, or as, a
joint. The joint is provided with a standard axle element and
interlacing fingers, such as in a typical door or piano hinge, or
one piece 48 may be in the shape of an eye and the other piece 49
may be in the shape of a hook, cooperating with each other, as is
seen in FIGS. 17A, 17B, 18A and 18B. These hinges demonstrate high
flexibility and a large range of motion, but have higher resistance
to tissue passage into the lumen 14 because of their increased
bulk. They are more difficult to manufacture economically, suffer
more binding between the parts with a greater tendency toward
failure to the hinge or even worse, hinge separation failure, than
with the other embodiments.
[0066] Second is a micro-machined or formed, tension/compression
live hinge where an area 24 of the door material itself flexes and
becomes a functional hinge. This bending or flexing area 24 of door
material may be thinned, narrowed, lengthened, or separated into
two or more active hinge segments to improve flexibility of the
bending area. The hinge element shaping or separation area 24 has
lines 25 generally formed or cut at right or high angles of 45 to
90 degrees to a hinge or flexing axis as is seen in FIG. 12.
Opposing, top and bottom surfaces of this live hinge structure are
alternately placed in tension and compression. These functional
hinges show higher initial strength with more limited flexibility,
lower cycle tolerances and higher failure rates due to molecular
strain and disruption in the area of tension, than the other
embodiments. Lengthening or broadening the hinge area 24 improves
flexibility but if the flexing area 24 is broadened in the hinge to
tip dimension, the longer flexing area 24 causes the door length
and fit to the lumen walls to change. More problems are experienced
than with the other embodiments, especially with changes of tissue
consistency, with unpredictable occlusion against the opposing wall
with either premature or incomplete closure to over rotation and
pass through of the intended support angle and door failure.
[0067] Third is a micro-machined or formed torsion live hinge where
an area 28 of the door material itself flexes and becomes a
functional hinge. This flexing area may be separated into two or
more active hinge element areas 28, 29, generally by
micro-machining or laser cutting, to improve flexibility, widen the
flexing area, decrease molecular strain and improve reliability.
The illustrated flexing areas extend perpendicularly to a
longitudinal direction of the door, between the hinge location 23
and the tip 35. However, it is merely a manipulation of the angle,
length, width, overlap and pattern, of the formed separations which
converts the tension/compression areas into improved function,
torsion areas. The hinge areas 28, 29 have separation lines 30, 32
that are formed or cut generally parallel to, or at low angles of 0
to 45 degrees to, the hinge or joint axis, as is seen in FIGS. 13,
14, 15 and 16. The lines 30 have holes 31 at the end for preventing
tearing as is seen in FIGS. 13 and 16. The lines 32 shown in FIGS.
14 and 15 are generally S-shaped with angles of 90 degrees within
the S and several straight segments 33 toward the periphery, so
that most lines extend across a greater region in the direction
from hinge to tip of the door 20 than the straight lines 30.
[0068] Opposing surfaces of these overlapping hinge areas 28, 29
are alternately placed in bi-directional or shared torsion, which
not only has low molecular strain or disruption but also less
flexing resistance. Narrowing, lengthening, or varying the overlap
or shape of the individual torsion areas 28, 29 by the form or
pattern of cuts of the lines 30, 32 or by adding additional torsion
zones, can improve flexibility and further reduces molecular
strain. This structure is functionally reliable, dimensionally
stable, has high flexibility, high cycle capability, high strength,
low heat build up, low molecular distortion and low failure rates.
This hinge structure works well with a broad range of tissue types
and consistencies.
[0069] Another important feature of the end-cutting door 20, is the
structure of a distal door tip 35, opposite from the hinge location
23. This tip 35 is tapered and sharpened on the side 36 facing away
from the distal end 3 of the lumen 14, and is turned down or angled
toward the center of the lumen as is seen in FIGS. 15 and 16. The
second or additional flexing area 29 facilitates the tip 35 to flex
away from the inward passing tissue and also flex into the
outwardly passing tissue. These four features are combined and
adjusted to act as a catch or barb, to hook into the tissue
specimen as the tissue attempts to reverse its movement in relation
to the needle 1, when the biopsy needle 1 is moved rearward or away
from the area of biopsy. The tissue plug or specimen, still being
connected to its organ system, will be held by its own tissue
cohesion and attempt to remain in place as the needle is withdrawn,
with the tissue being pulled out of the needle 1 unless the door
tip 35 intervenes.
[0070] This door tip 35 is constructed to be automatic in function.
At insertion, the tip 35 allows the tissue to pass without
restriction into the needle 1, but upon the first rearward movement
of the tissue, the tip catches and digs into the tissue. Cutting
into and across the specimen, which continues the further rotation
of the door 20 until it strikes the opposing contour fitting or
converging walls or sides 9-13 uniformly and simultaneously
severing or end cutting and capturing the tissue core of biopsy
specimen.
[0071] The biopsy specimen is now safely trapped within the lumen
14 and held by the automatic door 20 for easy and non-traumatic
removal. Just the simple act of insertion cleanly shear-cuts or
cores the specimen and just as simply withdrawal automatically
hooks, end cuts, severs, and captures the biopsy specimen. The
end-cutting door 20 is freely moveable within its controlled range
and needs no separate activation by the operator or automation. The
structure of the hinge location 23 and the digging-in movement of
the turned down distal door tip 35 create all the door rotational
forces.
[0072] The important structural elements of the biopsy needle
include: [0073] 1. The biopsy needle 1 having an inline, full size
lumen-matching syringe connector 6 at the proximal end 2, which is
continuous with the needle lumen 14 for vacuum application and
specimen removal and a tapered re-enforcement 5 for fitted
engagement with the biopsy needle carrier 50. [0074] 2. The distal
end 3 having a sharpened, double angled, shear cutting tissue
entrance 7 formed at approximately 45 degrees from the centerline
for straight forward, non-blind shearing of a core biopsy specimen.
[0075] 3. The needle 1 being constructed of several functionally
important structural cross-sectional shapes, with one side 8 being
straight or flat and opposing walls being symmetrical, constantly
closing angle or converging walls or sides 9-13 joining and forming
the needle tube. [0076] 4. The distal end 3 having a hinged,
end-cutting door 20, with a fixed, non-moving, hinge location 23
being permanently affixed to the flat side 8, and its tissue facing
forward edge 22 being tapered and sharpened. The hinged door 20,
rotating from its open or position of repose against the flat wall
side 8, allowing the tissue into the lumen 14, to the closed
position, against and occluding with, the opposing walls or sides
9-13, where the combination of the two complementary shaped
surfaces come together to sever and capture the biopsy specimen.
[0077] 5. The hinge structures include an articulating hinge, a
tension-compression or live one-piece functional hinge and a
torsion element live or one-piece functional hinge. [0078] 6. The
tip 35 of the hinged door 20 being tapered and sharpened on the
side 36 facing away from the distal end 3 of the lumen 14, coupled
with the tip 35 of the door being angled into the lumen and with
the additional hinging area 29 to catch and dig into the specimen
on its rearward movement. By intention, this angled portion causing
further rotation of the door 20 through and severing the specimen
upon impaction and occlusion with the opposing walls or sides 9-13
and capturing of the specimen.
[0079] The biopsy needle and trocar carrier 50 seen in FIG. 4 is a
tube-like structure with a permanently attached reinforcing area 51
and double grasping control rings 54, 55 surrounding a proximal end
52, toward the operator, with a tapered entrance channel 56 to
facilitate and protect the insertion of the trocar 40 or biopsy
needle 1 into the positions shown in FIGS. 7 and 8, respectively. A
distal end 53 has a right angle or straight across termination,
which is tapered and has a sharpened edge around its entire
circumference, to aid insertion into the subject tissue.
[0080] The biopsy needle carrier 50 is constructed of metal or
other suitable material, in matching variations of lengths from 8
cm to 40 cm and in equivalent cross-sectional diameters of 10 to 18
gauge. The carrier 50 has cross-sectional shapes matching the
biopsy needles 1 and trocars 40, but is slightly larger, since the
carrier is constructed to fit snuggly over the biopsy needle as
seen in FIG. 8B or over the trocar as seen in FIG. 8A, for ease of
introduction through the body layers and to safely contain and
support the biopsy needle 1 to the proper location and anglulation,
for beginning the biopsy coring, done by the biopsy needle 1,
through the carrier 50. The biopsy needle carrier 50 and the trocar
tip 41 have a smooth contour for insertion and penetration of
layers, as is seen in FIGS. 3, 4, 5, 6, 7, 8A and 8B.
[0081] The important structural features of the carrier 50 include:
[0082] 1. The biopsy needle carrier 50 having a conically shaped or
tapered entrance 56 to the lumen at the proximal end 52 for
facilitating the introduction of the biopsy needle 1 and trocar 40
without abrasion, damage or dulling of their sharpened edges.
[0083] The biopsy needle carrier 50 matching the cross-sectional
shapes of the biopsy needle 1 and trocar 40.
[0084] The biopsy needle carrier 50 being intentionally shorter
than the biopsy needle 1 by four centimeters as is seen at the
right side of FIGS. 5 and 8, providing for precise adjustability of
biopsy depth in 1 centimeter increments, from 4 cm down to 1 cm in
length.
[0085] The biopsy needle carrier 50 having tissue-penetrating
smooth walls, seen in FIG. 4.
[0086] The biopsy needle carrier trocar 40 seen in FIG. 3 is
configured and constructed of a suitable material to act as an
insertion and strengthening aid for the biopsy needle carrier 50.
In percutaneous biopsy, there are several layers of tissue which
the biopsy system must pass through, in order to reach the biopsy
site and since such relatively large bore needles cannot be made
with cutting tips because of tissue damage, a tapered and pointed
central lumen filler, or trocar 40 with a control ring 42, must be
added to assist insertion. The biopsy needle 1 is also relatively
long and is maneuvered during insertion with bends and angle
changes. These leverages or bending forces also require the
stabilizing and strengthening of the needle carrier 50 with a full
size strong trocar 40. The trocar 40 is constructed to fit snuggly
within the lumen of the biopsy needle carrier 50, matching the
carrier in size, cross-sectional shape and being slightly longer in
length with a finely tapered point 41 that protrudes from the
carrier 50 as is seen in FIGS. 6 and 7.
[0087] Insertion of the relatively large bore round object through
multiple fibrous layers meets with an exaggerated resistance
related to the phenomenon of pressure desiccation or drying and
stretching by the compression of tissue layers ahead of the trocar
40 and carrier 50.
[0088] The forced advancement of the encased round trocar 40 drives
the normal interstitial fluid from the contacting tissue and
stretches the fibrous layers, creating a collapsing, tightening,
fibrous tube surrounding the carrier 50 and trocar 40, much like a
Chinese finger trap. This pronounced increase in resistance takes
significant pressure to overcome, decreases the tactile feel or
proprioceptive feedback to the operator and increases the risk of
misplacement or break-through-over-insertion trauma to other organ
systems.
[0089] The trocar 40 and carrier 50 are inserted and maneuvered as
a single unit. Between biopsies, performed by the biopsy needle 1,
the trocar 40 is reinserted within the carrier 50 for any
repositioning or angle change of the carrier. The objective is to
insert and maneuver the carrier 50 to the perfect depth and
position, with the tip of the carrier just at the beginning of the
planned biopsy tract and at the proper angle for insertion of the
biopsy needle 1, with predictable, not blind, straight ahead core
cutting of the tissue of interest. The biopsy needle carrier 50 is
also constructed with etched markings 58 of insertion length, in
centimeters, on its outer lateral surfaces for more precise
placement, as is seen in FIGS. 4-7.
[0090] A single-piece, dual-use, four-separate-depth, adjustable
biopsy depth gauge and depth controller 60 is shown in detail in
FIGS. 19A and 19B. The controller is provided in recognition of the
importance of having at the operators' option, a method to gauge
and control the depth of the biopsy to protect contiguous organ
systems. The carrier 50 is placed with great intention in proper
position, relation, and angle to the target tissue and with the
biopsy needle 1 being 4 cm longer than the carrier 50. Thus, a
desirably safe, simple, easy to use, one-piece method to gauge and
control the reach or depth of the biopsy needle 1 beyond the
carrier 50 is presented.
[0091] The domino-shaped clip-on or slide-on controller 60
according to the invention, which contains three separate,
measured, dual use sides, shown in FIGS. 19A and 19B, satisfies
this requirement. The depth gauge and biopsy depth controller,
configured with the dual-use system, includes a multiplicity of
fitting regions, namely three self-grasping fitted slots 61, 62, 63
constructed for convenient snap-on, after needle insertion or
changing depth use and three matching, fitted holes 64, 65, 66, for
preplanned and more secure slide-on use. Without the controller 60,
the extension beyond the carrier or biopsy coring will be 4 cm in
depth, if clipped or fitted on the side with the shortest dimension
67, 3 cm in depth, if clipped or fitted on the side with the middle
dimension 68, 2 cm in depth and if clipped or fitted on the side
with the longest dimension 69, 1 cm in depth. The mounting of the
controller 60 between the needle 1 and the carrier 50 can be seen
in FIG. 7. The clip-on, slide-on gauge becomes a simple, effective
and safe structure to gauge and control biopsy depth.
[0092] A lockable, vacuum-assisted, coring and non-traumatic
specimen removal syringe 70 is shown in FIGS. 20A, 20B and 20C. The
syringe provides the desirable option to the operator of a method
for vacuum assisted biopsy coring. Tissues of extremely firm or
soft consistencies are difficult to advance cleanly into a biopsy
needle lumen and is the most common cause of biopsy recovery
failure. The application of a continuous vacuum throughout the
coring insertion pulls or assists the tissue migration into the
needle lumen 14. Once the biopsy needle 1 is inserted through the
carrier 50, and sealed against the target tissue, the lockable
vacuum-pulling syringe 70 is attached to the biopsy needle syringe
connector 6 using a larger-than-lumen, tapered and matching
conically shaped end 71 as is seen in FIG. 20B, and the vacuum is
applied by pulling out and locking a syringe plunger 72. Of course,
the controller 60 may be disposed between the biopsy needle 1 and
the carrier 50 in any of its positions, two of which are shown in
FIGS. 21A and 21B, depending on the desired depth of penetration,
as described above.
[0093] Another important structural feature of the locking syringe
is interlocking counter-angled edges. The edges firstly include a
narrow, upwardly-angled lip or peak 74 around the top of a syringe
body or cylinder 75, and secondly downwardly-angled notches 73
formed in the lower third of four blade-shaped columns 76 of the
plunger 72 of the syringe 70, three of which are seen in FIG. 20c.
An operational feature is that the syringe comes preloaded with
normal saline to fill the biopsy needle 1 while evacuating the air,
to provide a more effective vacuum seal upon insertion and
extraction of the specimen.
[0094] Once vacuum is applied, the plunger 72 is moved off center
as is shown in FIG. 20A, engaging and locking the two
counter-angled edges 73, 74, which are now held in the locked
position by the force of the pre-selected vacuum. The biopsy needle
1 is then advanced with vacuum assisted coring of the biopsy
specimen. The vacuum is automatically released upon withdrawal,
with exposure to the atmosphere.
[0095] The dual-use ability comes from the large needle to syringe
connector 6 and the residual vacuum of coring. Upon withdrawal, the
atmospheric pressure automatically and non-traumatically pushes the
cored specimen into the vacuum and specimen recovery syringe 70.
The biopsy specimen, contained within the syringe, can then be
released over an absorbent cloth by the operator and transferred
with non-grasping instruments into the pathology container and
preservative. The untouched biopsy specimen is maintained in
perfect condition. The biopsy is completed and quality is
assured.
[0096] The integrated, complete, and all-inclusive biopsy system is
constructed for multidisciplinary use. Its availability in sizes
(from 10 to 18 equivalent gauge) and lengths (from 8 cm to 40 cm)
makes it suitable for many biopsy techniques and procedures. The
hinge and needle shape variations, with the option of vacuum
assistance, create a compatibility with many tissue consistencies
or organ systems. Its increased reflectivity and visibility,
compatible to new imaging technologies, yield a level of control,
depth and angle precision not previously seen.
[0097] The invention provides a true end-cut tissue biopsy,
equaling the qualities of an open surgical biopsy, but using a
minimally invasive technique.
[0098] Improved, minimally invasive biopsies are now available for
fields including, but not limited to, the following: [0099] a.
unguided, percutaneous needle biopsy, as in obvious, palpable
subsurface solid masses; [0100] b. manually or finger-guided,
percutaneous biopsy, such as transrectal, or transperineal
prostatic needle biopsy, etc.; [0101] c. visually-guided, open
surgical needle biopsy with an exposed mass or tissue; [0102] d.
visually-guided, trans-orifice biopsy such as oral, nasal,
tracheal, or rectal needle biopsy, etc.; [0103] e. remotely or
virtually-visualized, and guided percutaneous needle biopsies of
internal organ systems, such as breast, lung, kidney or liver
biopsy, etc.; [0104] f. endoscopically-guided, percutanous or
trans-instrumental needle biopsy of internal organs such as
bladder, prostate, bronchial, esophagus, sigmoid, etc.; [0105] g.
laproscopically guided trans-abdominal, percutaneous or
trans-instrumental, needle biopsy of internal organs, including
ovary, bowel, uterus or unknown masses, etc.; and [0106] h. for
tissue confirmation of many non-malignant medical conditions.
* * * * *