U.S. patent application number 09/833312 was filed with the patent office on 2001-08-09 for biopsy needle and surgical instrument.
This patent application is currently assigned to Medical Device Technologies Inc.. Invention is credited to Terwilliger, Richard A..
Application Number | 20010012919 09/833312 |
Document ID | / |
Family ID | 22355659 |
Filed Date | 2001-08-09 |
United States Patent
Application |
20010012919 |
Kind Code |
A1 |
Terwilliger, Richard A. |
August 9, 2001 |
Biopsy needle and surgical instrument
Abstract
The present invention includes a biopsy needle for use in a
biopsy gun or as surgical instrument, capable of taking multiple
samples, and a guiding needle holder for holding a biopsy needle.
The biopsy needle includes an inner needle, also called a stylet,
and an outer needle, also called a cannula, and a guiding needle
holder. The stylet has a recess in the vicinity of its distal end
which receives the tissue sample. The guiding needle holder
includes an integrated spacer, and first and second connecting
elements. The first connecting element holds the proximal end of
the cannula and is displaceably attached along the length of the
integrated spacer. The second connecting element holds the proximal
end of the stylet and is fixedly attached to the distal end of the
integrated spacer. The connecting elements each have an opening
that facilitates insertion of the biopsy needle into a known biopsy
gun in either the cocked or uncocked position. In an alternate
embodiment, the guiding needle holder includes an integrated spacer
that fixedly holds the stylet, and a connecting element that
displaceably holds the cannula.
Inventors: |
Terwilliger, Richard A.;
(Estes Park, CO) |
Correspondence
Address: |
Susan D. Reinecke
MAYER, BROWN & PLATT
P.O. Box 2828
Chicago
IL
60690-2828
US
|
Assignee: |
Medical Device Technologies
Inc.
|
Family ID: |
22355659 |
Appl. No.: |
09/833312 |
Filed: |
April 10, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09833312 |
Apr 10, 2001 |
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09572418 |
May 17, 2000 |
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09572418 |
May 17, 2000 |
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09114509 |
Jul 13, 1998 |
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6110129 |
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Current U.S.
Class: |
600/567 |
Current CPC
Class: |
A61B 2010/0208 20130101;
A61B 10/0275 20130101 |
Class at
Publication: |
600/567 |
International
Class: |
A61B 010/00 |
Claims
we claim:
1. A biopsy needle, for use in and removable from a biopsy gun,
comprising: a guiding needle holder, comprising: an integrated
spacer, including a hole, a slot and an interior section including
a longitudinally extending groove, a curved wall, and an angled
wall, a first connecting element displaceably attached to said
integrated spacer and movable therein, wherein the first connecting
element includes: a first protruding section engaged to the
longitudinally extending groove, a first curved portion that fits
in the curved wall, and a first annular flange displaceably engaged
to the slot, wherein the first connecting element is positioned
along the length of the slot a predetermined distance to enable
insertion of said biopsy needle in a biopsy gun and is displaceably
guided along the length of the slot a distance sufficient to enable
operation of said biopsy needle in a biopsy gun, and a second
connecting element which includes a second annular flange fixedly
engaged to the hole, a second protruding section engaged to the
longitudinally extending groove, and a second curved portion
engaged to the curved wall; an inner needle having a recess in a
vicinity of a distal end thereof for receiving a tissue sample, and
a proximal end fixedly connected to said guiding needle holder such
that said inner needle does not move relative to said guiding
needle holder, wherein said inner needle is fixedly attached to the
second connecting element; and an outer needle substantially
coaxial with said inner needle and disposed about a portion of said
inner needle having a proximal end displaceably connected to said
guiding needle holder such that said outer needle moves
longitudinally relative to said guiding needle holder, wherein said
outer needle is connected to the first connecting element.
2. A biopsy needle, for use in and removable from a biopsy gun,
comprising: a guiding needle holder comprising: an integrated
spacer including a first hole, a slot, a longitudinally extending
groove, a curved wall, and an angled wall, and a connecting element
displaceably connected to said integrated spacer and movable
therein, wherein said connecting element includes: a protruding
section engaged to the longitudinally extending groove, a curved
portion that fits in the curved wall, and a flat portion, and an
annular flange displaceably connected in the slot, wherein the
connecting element is displaceably guided along the length of the
slot a distance sufficient to enable insertion of said biopsy
needle into a biopsy gun; an inner needle having a recess in a
vicinity of a distal end thereof for receiving a tissue sample, and
a proximal end fixedly connected to said guiding needle holder such
that said inner needle does not move relative to said guiding
needle holder, wherein said inner needle is fixedly connected to
the integrated spacer such that said inner needle does not move
relative to said integrated spacer; and an outer needle
substantially coaxial with said inner needle and disposed about a
portion of said inner needle having a proximal end displaceably
connected to said guiding needle holder such that said outer needle
moves longitudinally relative to said guiding needle holder,
wherein said outer needle is fixedly connected to said connecting
element.
3. A needle holder for guiding a biopsy needle for use in and
removable from a biopsy gun, comprising: an integrated spacer
including a hole, a slot, a longitudinally extending groove, a
curved wall, and an angled wall; a first connecting element
including: a first protruding section that fits in the
longitudinally extending groove, a first curved portion that fits
in the curved wall, a first flat portion, and a first longitudinal
bore, and a first annular flange connected in the slot such that it
is displaceable relative to said integrated spacer, wherein said
first connecting element is fixedly connected to said integrated
spacer; and a second connecting element including: a second
protruding section that fits in the longitudinally extending
groove, a second curved portion that fits in the curved wall, a
second flat portion and a second longitudinal bore, and a second
annular flange fixedly connected to the hole, wherein said second
connecting element is displaceably connected to said integrated
spacer such that said second connecting element is longitudinally
displaceably along said integrated spacer and is displaceably
guided along the length of the slot a distance sufficient to enable
insertion of a biopsy needle into a biopsy gun.
4. A needle holder for guiding a biopsy needle for use in and
removable from a biopsy gun comprising: an integrated spacer,
including a first hole, a slot, a longitudinally extending groove,
a curved wall, an angled wall, and a first longitudinal bore; and a
connecting element including a protruding section that fits in the
longitudinally extending groove, a curved portion that fits in the
curved wall, a flat portion, a second longitudinal bore, and a
raised hole displaceably connected in the slot, wherein said
connecting element is displaceably attached to said integrated
spacer and is displaceably guided along the length of the slot a
distance sufficient to enable insertion of a biopsy needle into a
biopsy gun.
5. A needle holder for holding an inner needle and a hollow outer
needle, wherein the inner needle comprises a recess near the distal
end thereof and extends through the hollow outer needle and the
outer and inner needles are movable relative to each other,
comprising: an integrated spacer comprising an interior section
including a longitudinally extending groove, a curved wall, and an
angled wall, wherein the integrated spacer is operatively fixed to
the inner needle when the inner needle and outer needle are moved
relative to each other; a first connecting element comprising a
first protruding section engaged to the longitudinally extending
groove, a first curved portion that fits in the curved wall of said
integrated spacer [coupled to a proximal end of the outer needle],
wherein said first connecting element is coupled to a proximal end
of the outer needle and is displaceably and directly connected to
said integrated spacer allowing the outer needle and said first
connecting element to move longitudinally relative to said
integrated spacer; and a second connecting element comprising a
second protruding section engaged to the longitudinally extending
groove, and a second curved portion engaged to the curved wall,
wherein said second connecting element is coupled to a proximal end
of the inner needle, and is fixably connected to said integrated
spacer.
6. A needle holder for holding an inner needle and a hollow outer
needle, wherein the inner needle comprises a recess near the distal
end thereof and extends through the hollow outer needle and the
outer and inner needles are movable relative to each other,
comprising: an integrated spacer including a hole, a slot and an
interior section comprising a longitudinally extending groove, a
curved wall, and an angled wall, wherein said integrated spacer is
attached to a proximal end of the inner needle; a connecting
element comprising a first annular flange displaceably engaged to
the slot and a first protruding section engaged to the
longitudinally extending groove, a first curved portion that fits
in the curved wall, wherein said connecting element is attached to
a proximal end of the outer needle, is positioned along the length
of the slot a predetermined distance to enable insertion of said
needle holder in a biopsy gun, and is displaceably guided along the
length of the slot a distance sufficient to enable operation of
said needle holder in a biopsy gun and the connecting element is
engaged to said integrated spacer for relative movement therein
whereby the inner needle is selectively moved to a position
exposing the recess of the inner needle and the outer needle is
moved to a position encapsulating the recess of said inner needle
when said needle holder is contained within a biopsy gun, wherein
the inner needle is operatively fixed to said integrated spacer
when the inner needle and outer needle are moved to expose and
encapsulate the recess and wherein said needle holder is removable
from the biopsy gun and wherein said connecting element remains
engaged to said integrated spacer and the inner needle remains
operatively fixed to said integrated spacer when the biopsy
instrument is removed from the biopsy gun; and a second connecting
element including a second annular flange fixedly engaged to the
hole and a second protruding section engaged to the longitudinally
extending groove, and a second curved portion engaged to the curved
wall, wherein said second connecting element is coupled to said
proximal end of the inner needle and is fixably connected to said
integrated spacer.
Description
[0001] This is a Divisional of application Ser. No. 09/572,418
which is a Divisional of application Ser. No. 09/114,509 filed Jul.
13, 1998, now patented as U.S. Pat. No. 6,110,129. This application
herein incorporates by reference U.S. patent application Ser. No.
09/572,418 and U.S. Pat. No. 6,110,129.
FIELD OF THE INVENTION
[0002] This invention relates to an improved biopsy needle
specially suited for use in a biopsy gun, or for use as a surgical
instrument.
BACKGROUND OF THE INVENTION
[0003] Biopsy needles, as part of a biopsy system, are generally
used in the medical field to remove tissue, cells or fluids from a
body for examination. Known biopsy needles have at least one inner
needle (stylet) and an outer needle (cannula). The stylet has a
point to enable insertion of the needle into a body, and a recess
or notch located near its distal end for receiving a tissue sample.
The cannula is displaceably guided on the stylet and has sharp
cutting edges. Both the stylet and cannula have a connecting
element on their proximal ends to enable connection of the needle
to the slides of a biopsy gun. The connecting elements in known
biopsy needles generally have included either flanges that
cooperate with matching contact surfaces on the slides, or recesses
that engage a rib located on a slide wherein both the slide and the
rib run along the length of the biopsy needle.
[0004] Some prior art biopsy needles have the disadvantage that it
is sometimes difficult to insert them into the biopsy gun under
sterile conditions. Some prior art biopsy guns require a certain
spacing between the connecting elements on the stylet and cannula
in order for the biopsy needle to be inserted into the biopsy gun.
However, this task of inserting the biopsy needle into the biopsy
gun while the connecting elements are maintained in a fixed
orientation is difficult because the stylet is generally freely
displaceable in the cannula. Therefore, it is generally necessary
to align the connecting elements of the biopsy needle, either
manually or through use of a separate spacer, prior to insertion
into a biopsy gun. After the biopsy needle is inserted into a
biopsy gun, if a spacer clip is used, it is generally necessary to
remove the spacer in order to close the lid and operate the biopsy
gun. Conventional spacer clips require the molding of a separate
spacer. This requirement of a separate molding step adds an
additional step in the manufacturing and packaging process thereby
increasing the costs to produce the biopsy needle. Moreover, the
use of a separate spacer clip may require undue handling of the
needle in order to connect and disconnect the spacer clip.
Furthermore, some conventional biopsy guns do not permit the option
of inserting the needle into a biopsy gun in the uncocked position.
By permitting a biopsy needle to be inserted in an uncocked biopsy
gun, the proper operation of the needle is checked prior to the gun
being fired by moving the inner needle and the outer needle
relative to each other during the cocking process. An additional
disadvantage of some conventional biopsy needles is that under some
conditions, the individual connecting elements slip or rotate
relative to the slides they are carried on when inserted in a
biopsy gun.
SUMMARY OF THE INVENTION
[0005] The present invention includes a biopsy needle particularly
suited for use in a biopsy gun. Additionally, the present invention
can also be used as a surgical instrument for procedures such as, a
microlumpectomy and the removal of microcalcification. The biopsy
needle made according to the present invention includes a guiding
needle holder that is an integral part of the needle itself that is
not removed prior to needle use. The guiding needle holder provides
not only an integrated means for grasping and handling the needle,
but facilitates needle alignment without the use of extrinsic
devices, and prevents rotation and other movement of the needle
relative to itself and the slides in a biopsy gun. Additionally,
the integrated design of the needle allows the needle to be easily
prepackaged in a sterile, disposable condition.
[0006] The biopsy needle of the present invention comprises an
inner needle with a recess near its beveled distal end, an outer
needle displaceably guided on the inner needle and having a beveled
distal end, and a guiding needle holder. The gauge and length of
the inner needle and outer needle varies with the procedure for
which it will be used. The guiding needle holder includes first and
second connecting elements, and an integrated spacer. The first
connecting element is displaceably guided along the length of the
integrated spacer, and the second connecting element is fixedly
engaged with the proximal end of the integrated spacer. Both the
first and second connecting elements contain a raised annular
flange that defines a portion of a bore though the connecting
element and assists in maintaining the connecting elements in
engagement with the integrated spacer. These bores in the
connecting elements allow the needle to be mounted on posts
extending from the slides of a biopsy gun. It should be noted that
these bores are illustrative of only one way to connect the needle
to the slides of a biopsy gun and that other arrangements may be
used. The inner needle is embedded in the second connecting element
and the outer needle is embedded in the first connecting element.
When the first and second connecting elements are maximally
displaced relative to each other within the integrated spacer, the
distance between the raised annular flange in the first connecting
element and the raised annular flange in the second connecting
element is such that the biopsy needle can be inserted with the
proper spacing into a biopsy gun in the cocked position. This
eliminates the need for any external means of achieving the proper
spacing of the needle. Alternatively, the needle can be mounted in
a biopsy gun in the uncocked position.
[0007] Additionally, the present invention can be used to take
multiple samples at the same biopsy site as required by procedures
such as computer tomography by removing the connecting element
carrying the inner needle and replacing it with another connecting
element and an inner needle. Once the body is pierced, the biopsy
needle is inserted into a biopsy gun and the sample taken. The
needle is then removed from the body and the biopsy gun, the sample
removed, and the needle can then be reused. All this is
accomplished without the use of an external spacer.
[0008] In an alternative embodiment, the guiding needle holder
incorporates an integrated spacer and a single connecting element.
The inner needle is embedded in the integrated spacer and the outer
needle is embedded in the connecting element. The biopsy needle can
be positioned for insertion into a biopsy gun either in the cocked
or uncocked position by maximizing the displacement of the
connecting element. In this embodiment, multiple samples can be
taken by dislodging the integrated spacer, removing the inner
needle and replacing it with another inner needle. The integrated
spacer can either be reused or replaced.
[0009] It is therefore an advantage of the present invention to
provide a biopsy needle that allows a tissue sample to be obtained
from a tissue mass which automatically captures and allows the
removal of a tissue sample for examination, wherein the inner
needle and the outer needle reside and function in an integrated
spacer.
[0010] It is a further advantage of the present invention to
provide an integrated spacer or guiding needle holder that does not
require the spacer to be removed prior to operating a biopsy
gun.
[0011] It is a further advantage of the present invention to
provide an integrated spacer that remains inside a biopsy gun
during the operation of the gun.
[0012] It is a further advantage of the present invention to
provide an integrated spacer for a biopsy needle which allows
single-handed loading and removal of the needle from a biopsy gun
while maintaining the orientation and rotational position of the
inner needle and outer needle of a biopsy needle relative to each
other and the biopsy gun.
[0013] It is a further advantage of the present invention to
provide a biopsy needle available in multiple needle gauges and
lengths, tailored for various biopsy procedures.
[0014] It is a further advantage of the present invention to
provide a biopsy needle including an integrated spacer which allows
the insertion of the needle into a body, unattached to the biopsy
device, without the use of external or removable spacers, and
maintains the orientation and proper spacing of the first and
second elements to allow the simple insertion of the biopsy needle
into a biopsy gun after the needle is inserted into the body, as
required by certain biopsy procedures.
[0015] It is a further advantage of the present invention to
provide a biopsy needle with an integrated spacer that allows the
integrated spacer to be gripped by the fingers of the user for
manual insertion of the needle into the body while maintaining the
spacial relationship between the inner needle and the outer
needle.
[0016] It is a further advantage of the present invention to
provide a biopsy needle that is prepackaged, sterile and
disposable.
[0017] It is a further advantage of the present invention to
provide a biopsy needle which can be used to obtain multiple biopsy
samples from the same biopsy site without the use of an external
spacer.
[0018] Other features and advantages of the present invention will
become readily apparent from the following detailed description,
the appended claims and the accompanying drawings. It is to be
understood that both the foregoing general description and the
following detailed description are exemplary and provided for
purposes of explanation only, and are not restrictive of the
invention, as claimed.
BRIEF DESCRIPTIONS OF DRAWINGS:
[0019] FIG. 1a is an isometric view of one embodiment of the biopsy
needle made according to the present invention;
[0020] FIG. 1b is an exploded view of the biopsy needle made
according to the present invention, positioned so that the recess
in the inner needle is exposed;
[0021] FIG. 2a is an end view of the integrated spacer;
[0022] FIG. 2b is an end view of a connecting element;
[0023] FIG. 3a is an end view demonstrating how the connecting
elements are inserted into the integrated spacer to form the
guiding needle holder;
[0024] FIG. 3b is an end view of the assembled guiding needle
holder;
[0025] FIG. 4a is an isometric view of an alternative embodiment of
the biopsy needle;
[0026] FIG. 4b is the bottom view of an alternative embodiment of
the biopsy needle; and
[0027] FIG. 5 is an isometric view of one embodiment of the biopsy
needle of the present invention used in conjunction with a biopsy
gun of a type that is well-known in the art.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0028] FIGS. 1a and 1b show a preferred embodiment of the biopsy
needle 10 made according to the present invention which comprises a
guiding needle holder 8, an inner needle 12 and an outer needle 14.
The design of the inner needle 12 and the outer needle 14 is
generally well known in the art and both have a beveled cutting
edge on their distal ends. The inner needle 12 and the outer needle
14 may be of a variety of gauge sizes. The guiding needle holder 8,
is used to maintain the relative orientation of the inner needle 12
and the outer needle 14, and to provide a means by which the biopsy
needle 10 can be grasped. The guiding needle holder 8 includes an
integrated spacer 20, and first and second connecting elements, 16
and 18 respectively.
[0029] The integrated spacer 20 has an elongated body which
includes a slot 28 that extends longitudinally a predetermined
distance and a hole 26 that facilitate the insertion of the biopsy
needle 10 into a biopsy gun of a type known in the art. As
illustrated in FIG. 2a, the integrated spacer 20 has an interior
portion 21 that includes a longitudinally extended angled wall 30,
a longitudinally extending curved wall 39, and a groove 31, that
facilitate the assembly and operation of the biopsy needle 10. The
groove 31, angled wall 30, and the curved wall 39, extend
longitudinally from the distal end 17 of the integrated spacer 20
through the entire length of the spacer 20. Alternatively, an end
wall at the proximal end of the spacer 20 may be provided. The
interior portion 21 is configured such that its cross-sectional
profile is similar to the cross-sectional profile of the first and
second connecting elements 16 and 18 of the needle 10 shown in FIG.
1b.
[0030] The first connecting element 16, shown in FIG. 2b, includes
a protruding section 33, a sidewall section including a curved
portion 35 and a flat portion 36, a longitudinally extending bore
32A that goes through the entire length of the first connecting
element 16, and a vertically extending bore 23 which is partially
defined by a raised annular flange 22. A portion of the bore 32A is
defined by a cylindrical sleeve 34 positioned on one end of the
first connecting element 16 shown in FIG. 1b.
[0031] For purposes of clarification, when referring to the
longitudinally extending bore through second connecting element 18,
the longitudinally extending bore will be referred to with
reference numeral 32B. The second connecting element 18,
illustrated in FIG. 1b, is identical to the first connecting
element 16, except that the longitudinally extending bore 32B is
not required to extend through the entire length of the second
connecting element 18. However, for purposes of ease of
manufacture, connecting elements 16 and 18 may be identical. The
longitudinally extending bore 32A of the first connecting element
16 holds the proximal end of the outer needle 14 and the
longitudinally extending bore 32B of the second connecting element
18 holds the proximal end of the inner needle 12. The connecting
elements 16 and 18 are preferably formed by insert molding
techniques generally known in the art. The connecting elements 16
and 18 are insert molded around outer needle 14 and inner needle
12, respectively. Although the preferred embodiment illustrates a
vertically extending bore 23 in the connecting elements 16 and 18
for engagement to the slides of a biopsy gun, other configurations
may be used, such as, for example, flanges.
[0032] To assemble the biopsy needle 10, the proximal end portion
of the outer needle 14 is fixedly carried in the longitudinally
extending bore 32A of the first connecting element 16. The proximal
end of the inner needle 12 is removable and fixedly inserted into
the longitudinally extending bore 32B of the second connecting
element 18. The inner needle 12 is then inserted into the outer
needle 14 until the first and second connecting elements 16 and 18
meet. In order to insert the first and second connecting elements
16 and 18 in the integrated spacer 20, both connecting elements 16
and 18 are initially engaged into the integrated spacer 20 with
curved portion 35 engaged with the curved wall 39 and flat portion
36 engaged with angled wall 30, as illustrated in FIG. 3a. The
second connecting element 18 is rotated into the integrated spacer
20 until the protruding portion 33 snaps into the groove 31 and the
second raised annular flange 24 fits into the hole 26 in the
integrated spacer 20. The first connecting element 16 is rotated
into the integrated spacer 20 until the protruding section 33 snaps
into the groove 31 and the first raised annular flange 22 in the
first connecting element 16 fits into the slot 28 in the integrated
spacer 20, as shown in FIG. 3b. In general use, the biopsy needle
10 remains in this attached configuration throughout its insertion
into a biopsy gun and its subsequent use. The length of the
longitudinal slot 28 is such that when the outer needle 14 is fully
extended, the distance between the first raised annular flange 22
in the first connecting element 16 and the second raised annular
flange 24 in the second connecting element 18 is sufficient to
enable the flanges to align with the posts on the slides of a
biopsy gun when the slides are in the cocked or uncocked positions.
The dimensions of the guiding needle holder 8 and the longitudinal
slot 28 may be configured to allow the biopsy needle 10 of the
present invention to be used in various biopsy guns.
[0033] The biopsy needle 10 made according to the present invention
provides several advantages over conventional biopsy needles and
even those conventional biopsy needles that employ separate spacer
clips. For example, when the biopsy needle 10 of the present
invention is in its assembled form as illustrated in FIG. 1a, the
first connecting element 16 is in the maximally displaced position
within the integrated spacer 20. The body of the integrated spacer
20 permits the user to easily grasp the biopsy needle 10 without
moving the position of connecting elements 16 and 18 relative to
each other. In this position, the distance between the first raised
annular flange 22 in the first connecting element 16 and the second
raised annular flange 24 in the second connecting element 18 is
sufficient to align these holes with posts located on the slides of
a cocked biopsy gun, and therefore enable the biopsy needle 10 to
be loaded into a biopsy gun without manipulation of the connecting
elements 16 and 18. The tip of the inner needle 12 is exposed to
facilitate insertion of the biopsy needle 10 into the tissue being
sampled.
[0034] The biopsy needle 10 including the integrated spacer 20 can
be inserted into a biopsy gun either in the cocked or uncocked
position to accommodate the user's preference. The integrated
spacer 20 also facilitates removal of the biopsy needle 10 from a
biopsy gun without the necessity to reattach a spacer clip as is
required with conventional biopsy needles. If the biopsy needle 10
is inserted while the gun is uncocked, the gun should be cocked
prior to use. Insertion of the biopsy needle 10 into a biopsy gun
60 is generally straight forward as shown in FIG. 5. The body of
the needle holder 8 is grasped by the user and placed over the
interior chamber of the biopsy gun 60, as illustrated in FIG. 5.
Vertically extending bore 23 of the first and second connecting
elements 16 and 18 are aligned over slides 62 of the biopsy gun 60
and receive posts 64.
[0035] Without having to remove the integrated spacer 20, the lid
to the biopsy gun 60 is closed and is ready for use.
[0036] The tip of the biopsy needle 10 is inserted into the tissue
to be sampled. The biopsy gun is then triggered and the second
connecting element 18 along with the integrated spacer 20 is moved
forward, while the first connecting element 16 is held stationary.
This action is accomplished though the novel arrangement of the
guiding needle holder 8 wherein flange 24 of second connecting
element 18 engages hole 26 while flange 22 of the first connecting
element 16 moves relative to the integrated spacer 20 in slot 28.
This movement causes the inner needle 12 to move forward into the
tissue being sampled and exposes the recess 13 in the inner needle
12 which receives the tissue to be sampled. The second slide of the
biopsy gun is triggered moving the slide engaged with the first
connecting element 16 forward. This action causes the outer needle
14 to move forward over the recess 13 which causes the outer needle
14 to separate tissue prolapsed in the recess 13 and secure it
therein. The biopsy needle 10, at this point, is back in the
position illustrated in FIG. 1a. The biopsy needle 10 can then be
removed and the tissue examined. The integrated spacer 20 in
engagement with the first and second connecting elements 16 and 18
during operation of the biopsy gun 60, stabilizes the first and
second connecting elements 16 and 18 and prevents twisting and
bending in the biopsy gun 60.
[0037] Multiple samples can be taken at the same biopsy site by
either reusing the biopsy needle 10 or replacing the inner needle
12. The inner needle 12 is replaced by removing the second
connecting element 18 from the integrated spacer 20, sliding the
inner needle 12 out of the outer needle 14, and inserting another
inner needle into the outer needle 14 and reattaching the second
connecting element 18 in the manner previously described. The
second connecting element 18 can either be reused or replaced.
[0038] An alternative embodiment of the invention is shown in FIGS.
4a and 4b. In this embodiment the biopsy needle 10A includes an
inner needle 42, an outer needle 44, and a guiding needle holder
40. The guiding needle holder 40 comprises an integrated spacer 48
and a connecting element 50. Connecting element 50 is identical to
connecting element 16 previously described. The integrated spacer
is substantially identical to integrated holder 20, except that
longitudinally extending groove 31, longitudinally extending wall
30 and longitudinally extending curved wall 39 do not extend as far
in the body of the spacer 20. The proximal end of the spacer 48 is
solid for ease of manufacturing and includes a vertically extending
bore 41. An inner needle 42 is fixedly attached to the integrated
spacer 48 near the proximal end, and the outer needle 44 is fixedly
attached to the connecting element 50. The connecting element 50
can be attached to the integrated spacer 48 in the manner
previously described herewith for attaching the first connecting
element 16 in the previous embodiment.
[0039] Other embodiments of the invention will be apparent to those
skilled in the art from consideration of the specification and
practice of the invention disclosed herein. It is intended that the
specification and examples be considered as exemplary only, with
the true scope and spirit of the invention being indicated by the
following claims.
* * * * *