U.S. patent application number 16/154148 was filed with the patent office on 2019-02-07 for tissue acquisition device with indication system.
This patent application is currently assigned to Cook Medical Technologies LLC. The applicant listed for this patent is Cook Medical Technologies LLC. Invention is credited to Thomas W. McGhie.
Application Number | 20190038267 16/154148 |
Document ID | / |
Family ID | 51530567 |
Filed Date | 2019-02-07 |
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United States Patent
Application |
20190038267 |
Kind Code |
A1 |
McGhie; Thomas W. |
February 7, 2019 |
TISSUE ACQUISITION DEVICE WITH INDICATION SYSTEM
Abstract
Among other things, there is disclosed a biopsy needle system in
which the needle is capable of obtaining more than one length of
sample. Generally, the needle includes an inner stylet, an outer
cannula, and a handle connected to the stylet and cannula. The
stylet has a notch that is extendable from the cannula to
accommodate a tissue sample. An insert member is provided for
attachment to the handle to make the amount of exposed notch
smaller. Consequently, when the insert member is not attached to
the handle, the needle can obtain a larger sample of tissue, and
when the insert member is attached to the handle, the needle can
obtain a smaller sample of tissue.
Inventors: |
McGhie; Thomas W.;
(Bloomington, IN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Cook Medical Technologies LLC |
Bloomington |
IN |
US |
|
|
Assignee: |
Cook Medical Technologies
LLC
Bloomington
IN
|
Family ID: |
51530567 |
Appl. No.: |
16/154148 |
Filed: |
October 8, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
14211595 |
Mar 14, 2014 |
10092276 |
|
|
16154148 |
|
|
|
|
61789924 |
Mar 15, 2013 |
|
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 10/0275 20130101;
A61B 2010/0208 20130101 |
International
Class: |
A61B 10/02 20060101
A61B010/02 |
Claims
1. A tissue sample acquisition device, comprising: a handle, the
handle having an upper surface adapted to generally face a user
during use of the device, the upper surface having at least first
and second openings; an actuator adapted to be pulled and pushed
with respect to the handle; a sampling portion having a slide
member operatively connected to the actuator and adapted to slide
with respect to the upper surface of the handle, an elongated
cannula at least partially extending from the handle, and a hub
connecting the cannula and the slide member, the sampling portion
having at least one visually contrasting portion, the at least one
visually contrasting portion having an immediately observable
visual contrast with one or more adjacent parts of the sampling
portion and with the handle; wherein at least part of the sampling
portion and the handle are movable with respect to each other
between at least a first relative configuration and a second
relative configuration, the first relative configuration
corresponding to an unarmed state in which the cannula is fully
forward and the second relative configuration corresponding to an
armed state in which the actuator is pulled back, and wherein when
the sampling portion and handle are in the first relative
configuration, at least part of the at least one visually
contrasting portion is visible through the first opening, and when
the sampling portion and handle are in the second relative
configuration, at least part of the at least one visually
contrasting portion is visible through the second opening.
2. The device of claim 1, wherein the at least one visually
contrasting portion is at least part of the slide member.
3. The device of claim 1, wherein the at least one visually
contrasting portion is at least part of the hub.
4. The device of claim 3, wherein the hub is a part fitted into the
slide member, the slide member being of substantially the same
color as the handle, and the hub at least partially of a color
visually contrasting with the slide member.
5. The device of claim 4, wherein the hub is of a solid color.
6. The device of claim 1, wherein the handle has a longitudinal
axis generally parallel to a portion of the elongated needle
adjacent to or within the handle, and wherein a line connecting the
first and second openings is generally parallel to the longitudinal
axis.
7. The device of claim 1, wherein the handle has a longitudinal
axis generally parallel to a portion of the elongated cannula
adjacent to or within the handle, and wherein the first opening is
laterally offset to a first side of the longitudinal axis and the
second opening is laterally offset to a second side of the
longitudinal axis, so that when the upper surface of the handle is
observed, the longitudinal axis is between and not intersecting the
first and second openings.
8. The device of claim 1, wherein the sampling portion includes
first and second visually contrasting portions, and wherein in the
first relative configuration the first visually contrasting portion
is visible through the first opening, and in the second relative
configuration the second visually contrasting portion is visible
through the second opening.
9. The device of claim 8, wherein the first and second visually
contrasting portions include different colors.
10. The device of claim 1, wherein the first relative configuration
is a relative position between the slide member and the surface
wherein the slide member is held at rest relative to the surface,
and the second relative configuration is a relative position
between the slide member and the surface wherein the slide member
has been retracted from the first relative configuration and is
held at rest relative to the surface.
11. (canceled)
12. The device of claim 1, wherein said slide member includes first
and second visually contrasting portions and a longitudinal axis,
wherein the first and second visually contrasting portions are
offset from each other longitudinally and offset laterally from and
on respective sides of the longitudinal axis.
13. The device of claim 12, wherein in the first relative
configuration, the first visually contrasting portion is visible
through the first opening, and in the second relative
configuration, the second visually contrasting portion is visible
through the second opening.
14. (canceled)
15. The device of claim 1, wherein in the first relative
configuration, a different view is visible through the second
opening, the different view comprising one of (a) a part of the
sampling portion visually similar to an area adjacent the second
opening and (b) empty space.
16. The device of claim 1, wherein in the second relative
configuration, a different view is visible through the first
opening, the different view comprising one of (a) a part of the
sampling portion visually similar to an area adjacent the second
opening and (b) empty space.
17. A tissue sample acquisition device, comprising: a handle having
a first observation area and a second observation area, each
observation area comprising a respective opening through the handle
and spaced from each other; an actuator adapted to be pulled and
pushed with respect to the handle; a sampling portion operatively
connected to the actuator and including an elongated member,
wherein the sampling portion and the handle have at least a first
relative configuration and a second relative configuration, the
first relative configuration corresponding to an operative state
that is either unarmed or armed to enable the sampling portion to
capture a size of tissue sample, and the second relative
configuration corresponding to an operative state that is armed to
enable the sampling portion to capture a different size of tissue
sample, and wherein when the sampling portion and handle are in the
first relative configuration, the first observation area has a
highlighted condition, and when the sampling portion and handle are
in the second relative configuration, the second observation area
has a highlighted condition.
18. The device of claim 17, wherein the first and second
observation areas cannot have their respective highlighted
conditions at the same time.
19. The device of claim 17, wherein the highlighted condition of
the first observation area includes visibility of a visually
contrasting portion of the sampling portion through the
opening.
20. The device of claim 17, wherein the first and second
observation areas are at least one of (a) longitudinally separated
from each other, and (b) laterally offset from each other on
respective sides of a longitudinal axis of the handle.
Description
[0001] This application is a divisional of U.S. patent application
Ser. No. 14/211,595, filed Mar. 14, 2014 which claims the benefit
of U.S. Provisional Application Ser. No. 61/789,924, filed on Mar.
15, 2013, which is incorporated herein by reference in its
entirety.
[0002] The present disclosure concerns devices such as biopsy
needles for obtaining a sample of human or animal tissue for
testing or study. In particular, it concerns tissue-obtaining
devices that allow a user to easily assure that the device is
correctly set for use even after user has begun.
BACKGROUND
[0003] A variety of biopsy needles and similar devices for
obtaining a tissue sample from a patient are known. Commonly, such
devices include a thin needle or stylet that can be inserted into
the skin of the patient near the location of tissue to be sampled,
such as suspected malignancies or other tissue of interest. Once
the distal end or other cutting portion of the needle or stylet is
within the tissue of interest, a portion of the tissue is excised
and captured. The needle or stylet is withdrawn with the tissue
sample, which can be retrieved from the device and studied.
[0004] Such products have proven quite effective in obtaining
tissue in a minimally-invasive manner and with minimal discomfort
to the patient. Their lightweight nature, combined with their ease
of operation and reusability, make them excellent for sampling
tissue that may present or indicate a health problem to the
patient.
[0005] Biopsy needles designed to obtain samples of a fixed length
are familiar, and in many cases that setting is either for a length
of sample of 10 mm or 20 mm. Biopsy needles or other tissue
sampling devices have been proposed that permit a variation of
sample size, as by allowing the user to select or set the throw
length to particular discrete settings for example. It can occur
that the user forgets the setting he or she has chosen, or whether
he or she has properly cocked or set the device for taking a sample
at all. Further, the user may wish to reconfirm the setting as a
part of his or her best practices. There remains a need for tissue
sampling devices capable of obtaining varying amounts of tissue
depending on a particular situation, and which permits easy
confirmation that the device is set for a desired sample size.
SUMMARY
[0006] Among other things, there is disclosed tissue sample
acquisition devices, such as biopsy needles, that include a handle
and a sampling portion. In particular embodiments, the handle has
an upper surface adapted to generally face a user during use of the
device, and which has first and second openings. The sampling
portion has a slide member adapted to slide with respect to the
upper surface of the handle, an elongated needle at least partially
extending from the handle, and a hub connecting the needle and the
slide member. The sampling portion includes at least one visually
contrasting portion, having an immediately observable visual
contrast with one or more adjacent parts of the sampling portion
and with the handle. At least part of the sampling portion and the
handle are movable with respect to each other between at least a
first relative configuration (corresponding to an unarmed state,
e.g. not ready for firing) and a second relative configuration
(corresponding to an armed state, e.g. ready for firing). When the
sampling portion and handle are in the first relative
configuration, at least part of the at least one visually
contrasting portion is visible through the first opening, and when
the sampling portion and handle are in the second relative
configuration, at least part of the at least one visually
contrasting portion is visible through the second opening.
[0007] Certain embodiments place the at least one visually
contrasting portion as at least part of the slide member, and/or as
at least part of the hub. The hub may be a part fitted into the
slide member, the slide member being of substantially the same
color as the handle, and the hub at least partially of a color
visually contrasting with the slide member. As particular examples,
the hub or other visually contrasting portion may be of a solid
color that is easily contrasted with the general color of the
handle. Where the cannula is partially within the handle and
emerges from the handle at a particular location, the first opening
may be closer to that particular location than is the second
opening. The handle's longitudinal axis (e.g. an axis generally
parallel to a portion of the elongated needle adjacent to or within
the handle) may be generally parallel to a line connecting the
first and second openings. Alternatively, the first opening can be
laterally offset to a first side of the longitudinal axis and the
second opening laterally offset to a second side of the
longitudinal axis, so that when the upper surface of the handle is
observed, the longitudinal axis is between and not intersecting the
first and second openings. The sampling portion can have multiple
visually contrasting portions, for example first and second such
portions, and in the first relative configuration a first visually
contrasting portion is visible through the first opening, and in
the second relative configuration a second visually contrasting
portion is visible through the second opening. Such multiple
visually contrasting portions can include different colors. The
first relative configuration may be a relative position between the
slide member and the upper surface of the handle wherein the slide
member is held at rest relative to the surface, and the second
relative configuration is a relative position between the slide
member and the surface wherein the slide member has been retracted
from the first relative configuration and is held at rest relative
to the surface.
[0008] In other embodiments, a biopsy needle or other tissue sample
acquisition device includes a handle that has a surface with first
and second openings. A sampling portion has an elongated cannula
that at least partially extends from the handle connected to a
slide member adapted to slide with respect to the surface. The
sampling portion has at least one visually contrasting portion, the
at least one visually contrasting portion having an immediately
observable visual contrast with one or more adjacent parts of the
handle. At least part of the sampling portion and the handle are
movable with respect to each other between at least a first
relative configuration and a second relative configuration. The
first relative configuration corresponds to a first armed state
operationally adapted to result in obtaining a first sample size,
and the second relative configuration corresponds to a second armed
state operationally adapted to result in obtaining a second sample
size different from the first sample size. When the sampling
portion and handle are in the first relative configuration, at
least part of the at least one visually contrasting portion is
visible through the first opening. When the sampling portion and
handle are in the second relative configuration, at least part of
the at least one visually contrasting portion is visible through
the second opening.
[0009] The slide member can include, in particular embodiments,
first and second visually contrasting portions and a longitudinal
axis, with the first and second visually contrasting portions
offset from each other longitudinally and offset laterally from and
on respective sides of the longitudinal axis. In the noted first
relative configuration, the first visually contrasting portion is
visible through the first opening, and in the second relative
configuration, the second visually contrasting portion is visible
through the second opening. The at least one visually contrasting
portion is at least part of a hub of the cannula in certain
embodiments, and in others may be part(s) of the slide member.
Embodiments are disclosed in which, in the first relative
configuration, a different view is visible through the second
opening, the different view including one of (a) a part of the
sampling portion visually similar to an area adjacent the second
opening and (b) empty space. Similarly, in the second relative
configuration, a different view may be visible through the first
opening, the different view comprising one of (a) a part of the
sampling portion visually similar to an area adjacent the second
opening and (b) empty space.
[0010] Embodiments of a tissue sample acquisition device (e.g.
biopsy needle) that include a handle with a first observation area
and a second observation area and a sampling portion including an
elongated member are disclosed. The sampling portion and the handle
have at least a first relative configuration and a second relative
configuration. The first relative configuration corresponds to an
operative state that is either unarmed or armed to enable the
sampling portion to capture a size of tissue sample. The second
relative configuration corresponds to an operative state that is
armed to enable the sampling portion to capture a size of tissue
sample. When the sampling portion and handle are in the first
relative configuration, the first observation area has a
highlighted condition, and when the sampling portion and handle are
in the second relative configuration, the second observation area
has a highlighted condition. A "highlight" or "highlighted
condition" indicates making more noticeable, drawing attention, or
making stand out compared to adjacent areas or items. In certain
embodiments, the first and second observation areas cannot have
their respective highlighted conditions at the same time. In
examples in which the first observation area is an opening, the
highlighted condition of the first observation area can include
visibility of a visually contrasting portion of the sampling
portion through the opening. The first and second observation areas
may be at least one of (a) longitudinally separated from each
other, and (b) laterally offset from each other on respective sides
of a longitudinal axis of the handle.
[0011] Examples include devices having a handle with opening(s)
observable by a user and a needle or cannula portion movable with
respect to handle. In one operational state, a portion of the
cannula (or a slide member associated with it) having a visual
contrast is viewable through an opening in the handle, to advise
the user of the device's operational state. One contrasting part of
the cannula or slide member may be selectively viewable in two
windows, each window indicating a respective operative state. Two
contrasting parts of the cannula or slide member may be selectively
viewable in two openings, or additional openings and/or contrasting
portions may be provided for devices capable of multiple
throw-lengths.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1 is an exploded perspective view of parts of an
embodiment of a biopsy needle system according to the present
disclosure.
[0013] FIG. 2 is a top view of an assembled embodiment as in FIG.
1.
[0014] FIG. 3A is a top view of a portion of an embodiment as in
FIG. 1.
[0015] FIG. 3B is a top view of a different embodiment of the
portion of FIG. 3A.
[0016] FIG. 3C is a cross-sectional view of the embodiment shown in
FIG. 3A.
[0017] FIG. 4A is a top view of an example of selected portions
usable with the embodiment of FIG. 3A.
[0018] FIG. 4B is a top view of an example of selected portions
usable with the embodiment of FIG. 3A.
[0019] FIG. 4C is a top view of an example of selected portions
usable with the embodiment of FIG. 3B.
[0020] FIG. 5A is a top view of a portion of an embodiment as in
FIG. 1 in a first (e.g. unarmed) configuration.
[0021] FIG. 5B is a top view of a portion of the embodiment of FIG.
1 in a second (e.g. armed) configuration.
[0022] FIG. 6A is a top view of a portion of an embodiment as in
FIG. 1 in a first (e.g. unarmed) configuration, with an embodiment
as in FIG. 3A attached.
[0023] FIG. 6B is a top view of a portion of the embodiment of FIG.
1 in a first (e.g. armed) configuration, with an embodiment as in
FIG. 3A attached.
DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS
[0024] For the purposes of promoting an understanding of the
principles of the disclosure, reference will now be made to certain
embodiments and specific language will be used to describe the
same. It will nevertheless be understood that no limitation of the
scope of this disclosure and the claims is thereby intended, such
alterations, further modifications and further applications of the
principles described herein being contemplated as would normally
occur to one skilled in the art to which this disclosure relates.
In several figures, where there are the same or similar elements,
those elements are designated with the same or similar reference
numerals.
[0025] Referring now generally to the drawings, there is shown an
embodiment of a device for acquiring one or more tissue samples, in
the particular form of a biopsy needle 20. Needle 20 includes an
inner member or stylet 22, an outer cannula 24 and a handle 26.
Stylet 22 is slidable within cannula 24, and both are connected to
and operable by handle 26 in this embodiment. Stylet 22 is
connected to a slide member 30, which is within and slidable with
respect to handle 26 in this embodiment.
[0026] Stylet 22 has an elongated body 32 extending between an
proximal end 34 and a distal end 36. Elongated body 32 is at least
substantially cylindrical in the illustrated embodiment for ease of
use and manufacture. Proximal end 34 is connected directly or
indirectly to handle 26, for operation during a biopsy procedure as
will be further discussed below. Distal end 36 may be sharpened,
for example by grinding a surface 38 that is planar and oblique to
the longitudinal axis of cannula 22.
[0027] Proximal of surface 38 there is formed in stylet 22 a notch
or indent 40. Notch 40 is provided so that tissue to be biopsied
enters notch 40 and is cut off and contained in notch 40, as
further discussed below. As a particular example, notch 40 has a
length measured in a longitudinal direction of at least 20 mm, so
that in such a case a maximum throw-length for needle 20 is at
least 20 mm.
[0028] The illustrated embodiment of cannula 24 is tubular, having
an elongated body 50 extending between a proximal end 52 and a
distal end 54. Proximal end 52 is directly or indirectly connected
to handle 26 for operation during the biopsy procedure. Distal end
54 includes a sharpened surface 60. In the illustrated embodiment,
an essentially planar oblique section is taken through cannula 24,
so that end surface 60 is formed with sharp edges. A hub 62 or
other connection is provided on cannula 24 in this embodiment to
link cannula 24 to slide member 30.
[0029] Handle 26 is connected to and operates each of stylet 22 and
cannula 24 so that stylet 22 is within cannula 24, and so that
stylet 22 and cannula 24 are slidable with respect to each other.
An example of structure usable as part of handle 26 is that
currently used with QUICK-CORE.RTM. products sold by Cook Medical
(Bloomington, Ind.). Embodiments with parts or structures
potentially usable in handle 26 are shown in U.S. Provisional
Application No. 61/261,857 (filed on Nov. 17, 2009), U.S.
application Ser. No. 13/293,162 (filed on Nov. 10, 2011), and U.S.
application Ser. No. 13/433,801 (filed on Mar. 29, 2012), the
entireties of which are incorporated herein by reference.
[0030] Handle 26, in the illustrated embodiment, includes a trigger
or actuator 70 connected to slide member 30, and a cover or housing
80. Handle 26 includes finger holds 82 which are substantially
circular in this embodiment, and a central track or channel 83 in
which slide member 30 is slidable forward and backward (proximally
and distally). One or more catches (not shown) are positioned in
channel 83 for holding slide member 30 when slide member 30 is
pulled sufficiently proximally. Actuator 70 includes a grip or pad
86 positioned at its proximal end in this embodiment, and a
distally-extending finger 87 with an end boss 88 that can engage
slide member 30 to draw it proximally.
[0031] Handle 26 further includes openings 90 in this embodiment,
for example two openings 90a, 90b shown in a particular instance
through cover 80. Openings 90 are (or are part of) an observation
area in handle 26. The term "opening" refers generally to the
concept of permitting visualization, and includes uncovered
apertures as well as those covered by transparent materials (e.g. a
clear plastic window). Openings 90 are large enough for a user to
be able to easily see through them and into handle 26, from a
distance of at least one to two feet from handle 26. The example of
FIGS. 1, 2 and 3A shows openings 90 as being linearly oriented with
each other, with their centers on a line that is parallel or along
a longitudinal axis of handle 26, and/or on a line that is parallel
to the direction of travel of slide member 30. The example of FIG.
3B shows openings 90 that are offset from each other and from a
longitudinal axis of handle 26 as viewed from above. A line between
the centers of openings 90 in FIG. 3B is substantially
perpendicular to a longitudinal axis of handle 26 and the direction
of travel of slide member 30. The illustrated embodiments show at
least first and second openings 90, and it will be understood that
one opening or additional (e.g. three or more) openings may be
present in other embodiments. In particular embodiments, respective
legends adjacent each opening 90 indicates a particular
configuration, as will be further discussed below. Cover 80 fits
over channel 83, covering and protecting sliding engagement between
slide member 30 and other internal parts of handle 26, e.g. from
debris and interference.
[0032] Slide member 30 is in the form of a substantially
rectangular solid in whole or part in the illustrated embodiment,
and is movable within channel 83 of handle 26. Slide member 30 is
coupled to a proximal portion of cannula 24, e.g. by inserting hub
62 or other portion of cannula 24 into an opening 94 (which may be
complementary to hub 62 or other portion of cannula 24) of slide
member 30, with cannula 24 extending from slide member 30. Slide
member 30 has an upper surface 96, which as illustrated may be
substantially planar throughout and substantially flush with hub 62
when hub 62 is seated in opening 94. When slide member 30 is within
channel 83, upper surface 96 faces and is directly under openings
90 through cover 80. In this embodiment, actuator 70 is connected
to stylet 22. A spring (not shown) is provided adjacent to slide
member 30 to propel slide member 30 and cannula 24 forward, as
discussed further below. The spring engages slide member 30 and an
internal surface of housing 26.
[0033] At least one visually contrasting area is provided on or in
one or more of the parts that move with respect to handle 26 or
parts of it. In the examples of FIGS. 4A and 4B, a visually
contrasting section 100 is on a portion of upper surface 96 of
slide member 30 and/or on part or all of an exposed portion of hub
62 of cannula 24. The embodiment of FIG. 4A places visually
contrasting section 100 on or in hub 62, which is adjacent or
surrounded by portions of slide member 30 that are visually similar
to handle 26 or portions of it surrounding openings 90. The
embodiment of FIG. 4B places visually contrasting section 100 on
upper surface 96 of slide member 30, with adjacent or surrounding
portions of the surface 96 that are visually similar to each other
and to at least part of handle 26 adjacent to or surrounding
openings 90. The example of FIG. 4C shows slide member 30 including
two separated visually contrasting sections 100, offset from each
other longitudinally and offset on either side of a longitudinal
axis A of slide member 30. As further explained below, the visually
contrasting area(s) 100 and openings 90 are intended to at least
partially align at particular configurations of needle 20, e.g. at
particular relative locations of slide member 30 with respect to
handle 26, so that the user can observe one or more visually
contrasting area(s) 100 through one or more opening(s) 90.
[0034] By "visually similar" it is meant that the characteristics
observable to the eye of a user are very close to or identical to
those of other parts, such as the cover 80 and/or other parts of
handle 26. For example, if cover 80 is a white or beige color, a
lighter neutral color (e.g. white, beige or similar off-white)
would be visually similar. By "visually contrasting" it is meant
that the characteristics observable to the eye of a user are
dissimilar to other parts. Thus, if cover 80 is a white or beige
color, visually contrasting colors could include green, red, blue,
black and/or others. Further, a visually contrasting area can have
or include markings or textures that visually contrast, such as
stripes, dots, hatching or other features, particularly where
surrounding or adjacent area(s) are of a solid color or have
different markings. It will be understood that combinations of
color, marking, texture and/or other differences can be used to
create visually contrasting areas 100.
[0035] Handle 26 is cocked or armed for use by pulling actuator 70
(e.g. via grip 86) backward, i.e. out or away from finger grips 82
and/or the rest of handle 26. With actuator 70 engaging slide
member 30, when actuator 70 is pulled, slide member 30 is pulled
backward (proximally) within or with respect to handle 26,
compressing a spring until a catch engages and holds slide member
30 to maintain an armed or cocked position. Pulling grip 86
proximally moves both cannula 24 and stylet 22 together,
maintaining their respective tips at approximately the same
location.
[0036] In particular embodiments, a needle 20 has a single armed
configuration, corresponding to a single throw-length. In such
cases, the needle is either armed or unarmed, and the cannula 24 is
either fully forward (in the unarmed configuration) or is retracted
and held against the force of a compressed spring (in the armed
configuration). In the unarmed configuration, a visually
contrasting region 100 is visible through a particular opening 90,
e.g. the furthest forward opening 90a. Adjacent that furthest
forward opening 90a, as suggested above, may be a legend indicating
"UNARMED" or similar notation, so that when a visually contrasting
region 100 is visible through it, the user will understand that
needle 20 is unarmed. In the armed configuration, a visually
contrasting region 100 is visible through a different particular
opening 90, e.g. the rearward opening 90b. Adjacent that rearward
opening 90b, as suggested above, may be a legend indicating "ARMED"
or similar notation, so that when a visually contrasting region 100
is visible through it, the user will understand that needle 20 is
armed and capable of firing.
[0037] In other embodiments, a needle 20 has two or more armed
configurations, each corresponding to a particular throw-length.
For example, a two throw-length needle may be armable or cockable
to a first or intermediate position for a 10 millimeter
throw-length, and to a second or farthest position for a 20
millimeter throw-length. In such cases, the needle is either (1)
unarmed, (2) armed for the first throw-length, or (3) armed for the
second throw-length. In the first armed configuration (for the
first throw-length), cannula 24 is retracted against spring force
to a first location, and a visually contrasting region 100 is
visible through a particular opening 90, e.g. the furthest forward
opening 90a. Adjacent that furthest forward opening 90a, as
suggested above, may be a legend indicating the first throw-length
(e.g. "10 MM" or similar notation), so that when a visually
contrasting region 100 is visible through the opening, the user
will understand that needle 20 is armed for the first throw-length.
In the second armed configuration, a visually contrasting region
100 is visible through a different particular opening 90, e.g. the
rearward opening 90b. Adjacent that rearward opening 90b, as
suggested above, may be a legend indicating the second throw-length
(e.g. "20 MM" or similar notation), so that when a visually
contrasting region 100 is visible through it, the user will
understand that needle 20 is armed for the second throw-length. In
such embodiments, if a visually contrasting region is not visible
through either window, it indicates that needle 20 is unarmed. It
will be understood that in other embodiments a third opening 90 is
placed in a location forward (more proximal) of an opening 90
corresponding to a first (shorter) throw-length, perhaps with an
"UNARMED" or similar legend, so that when unarmed a visually
contrasting region will be visible through such more-forward
opening.
[0038] It will further be understood that additional throw-lengths
can be provided in a needle 20, with corresponding armed
configurations (i.e. relative locations where slide member 30 is
held with respect to handle 26) and openings in handle 26.
Regardless of the number of throw-lengths provided in a needle,
openings and visually contrasting region(s) can be provided so that
a region shows through one opening when the needle is in one
operational condition (e.g. armed for a particular throw-length, or
unarmed), and a region shows through another opening when the
needle is in a different operational condition (e.g. armed for
another particular throw-length, or simply armed).
[0039] Once needle 20 is cocked, the user can perform additional
steps in order to fire cannula 24 and obtain a tissue sample. In
some embodiments, needle 20 can be primed by moving stylet 22
forward into tissue, exposing notch 40 at least partially beyond
the distal end of cannula 24. Needle 20 is fired to capture tissue
within notch 40 by releasing spring 78 to move cannula 24 quickly
forward over stylet 22 and notch 40. For example, applying force
(e.g. through actuator 70) to slide member 30 and/or the catch
holding it so as to release or overcome the hold and allow the
compressed spring push to slide member 30 and thrust cannula 24
over notch 40 of stylet 22. Thus, in the illustrated embodiment
firing the inserted and cocked needle 20 propels cannula 24 over
stylet 22, and particularly over notch 40 or the portion of notch
40 that extends from the distal end of cannula 24. The cutting
action of cannula 24 via its sharpened distal end 60 during that
movement severs and traps tissue within notch 40.
[0040] Handle 26 permits the user to be assured and to easily check
whether the device is cocked or armed, and/or whether armed for the
desired throw-length, when the distal end of the needle is within
the patient and so not directly observable. The use of needle 20
will now be described in the context of obtaining a sample of soft
tissue for testing purposes. It will be understood that methods for
obtaining samples of other tissues or for other purposes are also
contemplated.
[0041] The surgeon or other medical professional first determines a
location in a patient, with its depth under the skin, from which a
tissue sample is desired. In one embodiment, stylet 22 and cannula
24 of needle 20 are initially in the above-noted first relative
position, e.g. with the distal ends of stylet 22 and cannula 24
substantially co-extant or adjacent. The user considers what length
of sample he or she believes is needed. The below-described example
concerns a needle providing a choice between two throw lengths,
e.g. 10 millimeters (with a first catch position for slide member
30) and 20 millimeters (with a second catch position for slide
member 30).
[0042] The user cocks needle 20, as noted above, by pulling
actuator 70 of handle 26 until slide member 30 catches at the
desired position. In the cocked state, in this embodiment, stylet
22 and cannula 24 are in a relative position. Such arming of needle
20 can occur either prior to insertion of needle 20 into the
patient, or can occur when the distal end of needle 20 has been
inserted to or adjacent to a desired location in the patient.
[0043] The user places distal ends 36 and/or 54 of stylet 22 and/or
cannula 24 against the skin at a place proximate to the desired
location, and inserts needle 20. Needle 20 forces a path through
the skin and subcutaneous tissue to a point in or just before the
location from which a sample is to be taken. If needle 20 has not
previously been cocked or armed for a desired throw-length, then
that step can be performed with the distal end of needle 20 inside
the patient. Further manipulations to prime or otherwise prepare
the needle for firing may be performed.
[0044] At any time the user may check to ensure that the needle is
armed, and/or if the needle is armed for the desired throw-length.
The user can look down to handle 26 and observe openings 90. If the
user observes an empty opening (e.g. no part of slide member 30 or
hub 62 is visible) or if a visually similar region of slide member
30 and/or hub 62 is visible through an opening, it is an indication
to the user that the state indicated by that opening is not the
current state of the device. If the user observes an opening
through which a visually contrasting region (e.g. of slide member
30 and/or hub 62) is visible, it is an indication to the user that
the state indicated by that opening is the current state of the
device.
[0045] Thus, in a needle 20 having two throw-lengths and separate
openings indicating each respective throw-length, the user can
immediately tell which throw-length the needle is armed for. If the
user observes a visually contrasting region through the opening
corresponding to the first throw-length, he or she knows the needle
is armed for the first-throw length. A visually similar region or
an empty space may be visible in the other opening. If a visually
similar region or an empty space is visible in both openings, it is
an indication that the needle is unarmed. As another example, in a
needle having one armed condition, and respective openings
indicating an armed and unarmed condition are provided, in the
armed condition a visually contrasting region will be visible
through the opening corresponding to the armed condition. A
visually similar or empty space may be visible through the opening
corresponding to the unarmed condition. Conversely, in the unarmed
condition a visually contrasting region will be visible through the
opening corresponding to the unarmed condition, and a visually
similar or empty space may be visible through the opening
corresponding to the armed condition. The user need not see the
distal end of needle 20 in order to determine whether it is armed
as he or she desires.
[0046] Having verified that needle 20 is in the desired armed
condition, the user releases the hold on slide member 30, as
indicated above, to fire cannula 24 forward. Slide member 30 moves
forward from its armed or cocked position to its unarmed or rest
position (e.g. as far forward as handle 26 will allow). The cutting
action of cannula 24 severs the sample of tissue within notch 40.
Tissue outside notch 40, either radially or longitudinally, is not
trapped in notch 40 between cannula 24 and stylet 22.
[0047] After firing, needle 20 is withdrawn from the patient. Once
needle 20 is withdrawn, the tissue sample is removed by cocking and
priming needle 20, as indicated above, to expose notch 40 and the
tissue within it. The tissue sample can be extracted from notch 40
using a forceps or other tool, or in some embodiments by inverting
notch 40 and allowing the tissue to drop out of notch 40 into a
specimen dish or other container. If the user determines that
additional sample(s) are needed, then the procedure above can be
repeated to obtain such samples.
[0048] While an illustration of needle 20 discussed above has two
throw-length settings, exemplified as 10 millimeters and 20
millimeters, it will be understood that other throw lengths can be
used in place of one or both of such lengths. Further, as noted
previously it will be understood that three or more throw-length
settings may be provided in a needle system or kit, by providing
three or more catches each holding slide member 30 at respective
different positions with respect to handle 26. As one example, a
system or kit may be provided having sterilized parts including a
needle 20 with a largest throw-length of 20 millimeters, and two
smaller, intermediate lengths, such as 15 and 10 millimeters.
[0049] As used herein, the term "throw length" is intended to
indicate a measurement of the length of a tissue sample obtained
and/or the distance a part is moved forward in use of the device.
For example, a 20 millimeter throw length for the embodiments noted
above indicates that stylet 22 is advanced in the priming step so
that approximately 20 millimeters of notch 40 (or the entire notch
40 if its length is 20 millimeters, in this example) is exposed
from cannula 24.
[0050] While the disclosure has been illustrated and described in
detail in the drawings and foregoing description, the same is to be
considered as illustrative and not restrictive in character, it
being understood that only certain specific embodiments have been
shown and that all changes and modifications that come within the
spirit of the disclosure are desired to be protected. It is to be
understood that features described with respect to one embodiment
or aspect of the disclosure can be used with other embodiments or
aspects of the disclosure.
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