Note: Descriptions are shown in the official language in which they were submitted.
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CURVED SUTURE NEEDLES HAVING A NON-SMOOTH PROFILE
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This patent application claims the benefit of US Provisional
Application
63/076,925 filed 10 September 2020 and US Provisional Application 63/076,920
filed 10
September 2020; each of which is incorporated herein by reference in its
entirety for all
purposes.
TECHNICAL FIELD
[0002] The present disclosure generally relates to curved suture
needles, and suture
needles having a tapered transition portion.
BACKGROUND
[0003] Suturing procedures used to close wounds or incisions consume
a
considerable amount of time during a surgical procedure. Generally, the
instruments
used in suturing procedures are the suturing material, the suturing needle,
and the
suturing driver. Efforts made to reduce the time and enhance the safety of the
procedure have mainly focused on modifications to the needle driver.
[0004] The traditional way of driving a needle has been to clamp it
down between
two flat tips of a needle driver. This forms a static relationship between the
needle and
needle driver because the needle, once clamped down between the flat tips,
cannot
move relative to the driver. Moreover, needle drivers are generally designed
to fit right-
handed users. Thus, left-handed users have difficulties performing the
suturing
procedure. The right handedness of those devices further affects the capacity
of left-
handed surgeons to lock and unlock the drivers' locking mechanism. This
increases the
risks of negative outcomes for patients from wrong needle driver maneuverings.
[0005] Recent advances in needle drivers address these deficiencies,
including at
least this static relationship of the needle and the handedness of the prior
art drivers.
[0006] Current curved suture needles have not been designed for, and
therefore
cannot optimally perform, this task because they were not designed to work
with new
roller needle drivers.
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[0007] Additionally, when trying to drive standard swaged needles
with these new
ergonomic rotational action needle drivers, the rollers generally need to be
opened to
move over the swage end of the needle. That is, the swage represents a step or
lip on
the needle that may be damaged by the rollers, or conversely, that may damage
the
rollers.
[0008] Accordingly, new needle designs that may enable needle
driving by new
needle drivers are desirable and an object of the present disclosure.
[0009] Additionally, new needle designs that may enable smooth
loading of a
swaged needle by these new needle drivers are desirable and an object of the
present
disclosure.
SUMMARY
[0010] All references, including any patents or patent applications
cited in this
specification are hereby incorporated by reference. No admission is made that
any
reference constitutes prior art. The discussion of the references states what
their
authors assert, and the applicants reserve the right to challenge the accuracy
and
pertinence of the cited documents. It will be clearly understood that,
although a number
of prior art publications are referred to herein, this reference does not
constitute an
admission that any of these documents form part of the common general
knowledge in
the art.
[0011] It is acknowledged that the term 'comprise' may, under
varying jurisdictions,
be attributed with either an exclusive or an inclusive meaning. For the
purpose of this
specification, and unless otherwise noted, the term 'comprise shall have an
inclusive
meaning - i.e. that it will be taken to mean an inclusion of not only the
listed components
it directly references, but also other non-specified components or elements.
This
rationale will also be used when the term 'comprised' or 'comprising' is used
in relation
to one or more steps in a method or process.
[0012] The present disclosure provides a suturing needle comprising
a needle tip
portion having a needle tip at a distal end for piercing tissue; a curved
trunk portion
having a distal end connected to a proximal end of the needle tip portion; and
a thread
attachment portion, which may be formed as part of the suturing needle or as a
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separate component coupled to the suturing needle, connected to a proximal end
of the
trunk portion for connecting a suturing thread, wherein the needle tip portion
is formed
to become gradually thicker from the needle tip to the proximal end thereof,
and wherein
the curved trunk portion is formed to have a substantially circular cross-
section having a
non-smooth profile. In one or more embodiment(s), the suturing needle
comprises at
least one of a circular, an oval, an ellipsoidal, an oblong, a semi-circular,
a triangular, a
square, a rectangular, a pentagonal, a hexagonal, a heptagonal, an octagonal,
a
nonagonal, a decagonal, or a polygonal having more than ten sided, cross-
section. In
one or more embodiment(s), the suturing needle comprises multiple varied cross
sections, including any combinations of the foregoing cross-sections.
[0013] The present disclosure also provides a suturing needle
comprising a needle
tip portion having a needle tip at a distal end for piercing tissue; a needle
body having a
distal end connected to a proximal end of the needle tip portion; a suture
thread
attached to a proximal end of the needle body by a thread attachment
component; and
a tapered transition portion, for example, in the form of a ramp, extending
from the
proximal end of the needle body and covering the thread attachment component
and at
least a portion of the suture thread.
[0014] According to certain embodiments, a first end of the tapered
transition portion
proximal the needle body has a diameter approximately equal to or slightly
larger than a
needle body diameter, and a second end of the tapered transition portion
opposite the
first end has a diameter equal to or slightly larger than a suture thread
diameter, and
wherein the tapered transition portion provides a smooth transition from the
first end to
the second end thereof. The tapered transition portion may be flexible. The
tapered
transition portion may be formed of a cyanoacrylate, or any other suitable
biocompatible
material.
[0015] According to certain embodiments, the needle body may be
curved or
straight. Moreover, the needle tip portion is formed to become gradually
thicker from the
needle tip to the proximal end thereof. The needle tip may be sharp or blunt.
[0016] According to certain embodiments, the needle tip portion and
curved trunk
portion are formed of a steel wire, a martensitic stainless steel, or an
austenitic stainless
steel, or any other suitable biocompatible material.
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[0017] According to certain embodiments, the non-smooth profile
comprises a
plurality of equally spaced indentations extending longitudinally on and
parallel to the
curved trunk portion. The non-smooth surface may comprise 2, 3, 4, 5, 6, 7, 8,
9, 10, 11,
12, 13, 14, 15, 16, 17, 18, 19, 20, about 25, about 30, about 35, about 40,
about 45,
about 50, about 60, about 70, about 80, about 90, about 100, about 150, about
200,
about 250, about 300, about 350, about 400, about 450, or about 500 equally
spaced
circumferential indentations forming ridges. In one or more embodiment(s) the
non-
smooth surface may comprise 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15,
16, 17, 18,
19, 20, about 25, about 30, about 35, about 40, about 45, about 50, about 60,
about 70,
about 80, about 90, about 100, about 150, about 200, about 250, about 300,
about 350,
about 400, about 450, or about 500 non-equally spaced indentations forming
ridges, or
any number in between. In one or more embodiments, the non-smooth surface may
comprise milli-indentations, micro-indentations, or nano-indentations. In one
or more
embodiments, the ridges have a convex shape. In one or more embodiments, the
ridges have a flat peak, a pointed peak, a rounded peak, or a bumpy peak. In
one or
more embodiments, the peaks are smooth, rough, textured, ribbed, tacky, or
polished.
[0018] According to certain embodiments, the circumferential
indentations extend
along a full length of the curved trunk portion.
[0019] According to certain embodiments, the circumferential
indentations may be
angled on the needle body to form a spiral thereon. The spiral may be right-
handed or
left-handed. Moreover, the needle body may comprise at least two regions of
circumferential indentations having different angles on the curved needle
body.
[0020] According to certain embodiments, the suture needles may
comprise a suture
thread connected to the thread attachment portion.
[0021] According to certain embodiments, the suture thread may be
monofilamentary
or multifilamentory. The suture thread may be non-bioabsorbable or
bioabsorbable.
The suture thread may comprise at least one region of tissue retaining
structures, such
as barbs. According to certain embodiments, the at least one region of tissue
retaining
structures may be distal from the thread attachment region.
[0022] According to certain embodiments, the suture needle may
further comprise a
tapered transition portion extending from the proximal end of the curved trunk
portion
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and over the thread attachment portion and at least a portion of the suture
thread, and
configured to provide a smooth transition from a suture thread diameter to a
curved
trunk portion diameter. The tapered transition portion may be flexible. The
tapered
transition portion may be formed of a cyanoacrylate, or any other suitable
biocompatible
material.
[0023] The present disclosure further provides a method of suturing
tissues using a
rotational needle driver, the method: (a) providing a suture needle
comprising: a needle
tip portion having a needle tip at a distal end for piercing tissue; a needle
body having a
distal end connected to a proximal end of the needle tip portion; a suture
thread
attached to a proximal end of the needle body by a thread attachment
component; and
a tapered transition portion extending from the proximal end of the needle
body and
covering the thread attachment component and at least a portion of the suture
thread;
(b) grasping, between rollers of the roller needle driver, the suture thread
or the tapered
transition portion distal from the needle body; (c) loading the needle so that
the rollers
are positioned on the needle body without opening the rollers; (d) driving the
needle
through the tissues being subjected to suture; (e) moving the needle through
the tissues
without releasing the needle from the tissue; (f) grasping the curved suture
needle at an
end opposite from an end grasped in step (b); and (e) repeating steps (d) ¨
(f) until
completion of the suturing process.
[0024] The present disclosure further provides a method, comprising:
(a) grasping
the curved suture needle of claim 1 with a roller needle driver so that the
non-smooth
profile of the curved trunk portion fits securely within grooves of a
plurality of rollers of
the needle driver; (b) driving the curved suture needle through a tissue being
subjected
to suture; (c) moving the curved suture needle through the tissue without
releasing the
needle from the tissue; (d) grasping the curved suture needle at an end
exiting from the
tissue through which the curved suture needle was moved; and repeating steps
(a) ¨ (d)
until completion of the suturing process.
[0025] In certain embodiments, the curved suture needle may be
grasped by the
roller needle driver between the plurality of rollers so that the needle is
perpendicular to
the rollers; parallel to the rollers; or an angle from 0 degrees (parallel) to
90 degrees
(perpendicular), including an angle of about 0 degrees, about 5 degrees, about
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degrees, about 15 degrees, about 20 degrees, about 25 degrees, about 30
degrees,
about 35 degrees, about 40 degrees, about 45 degrees, about 50 degrees, about
55
degrees, about 60 degrees, about 65 degrees, about 70 degrees, about 75
degrees,
about 80 degrees, about 85 degrees, about 90 degrees, about 95 degrees, about
100
degrees, about 105 degrees, about 110 degrees, about 115 degrees, about 120
degrees, about 125 degrees, about 130 degrees, about 135 degrees, about 140
degrees, about 145 degrees, about 150 degrees, about 155 degrees, about 160
degrees, about 165 degrees, about 170 degrees, about 175 degrees, about 180
degrees, about 185 degrees, about 190 degrees, about 195 degrees, about 200
degrees, about 205 degrees, about 210 degrees, about 215 degrees, about 220
degrees, about 225 degrees, about 230 degrees, about 235 degrees, about 240
degrees, about 245 degrees, about 250 degrees, about 260 degrees, about 265
degrees, about 270 degrees, about 275 degrees, about 280 degrees, about 285
degrees, about 290 degrees, about 295 degrees, about 300 degrees, 305 degrees,
about 310 degrees, about 315 degrees, about 320 degrees, about 325 degrees,
about
330 degrees, about 335 degrees, about 340 degrees, about 345 degrees, about
350
degrees, about 355 degrees, about 360 degrees, or about any amount in between
with
respect to the rollers, from any orientation. This would equate to from 0
degrees to 360
degrees when comparing the position of the needle with respect to the roller
needle
drive being oriented in a fixed position.
[0026] The system as described herein, both as to its configuration
and its mode of
operation will be best understood, and additional objects and advantages
thereof will
become apparent, by the following detailed description of a preferred
embodiment taken
in conjunction with the accompanying drawing.
[0027] When the word "invention" is used in this specification, the
word "invention"
includes "inventions", that is, the plural of "invention". By stating
"invention", the
Applicant does not in any way admit that the present application does not
include more
the one patentable and non-obviously distinct invention and Applicant
maintains that the
present application may include more than one patentably and non-obviously
distinct
invention. The Applicant hereby asserts, that the disclosure of the present
application
may include more than one invention, and, in the event that there is more than
one
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invention, that these inventions may be patentable and non-obvious one with
respect to
the other.
[0028] Further, the purpose of the accompanying abstract is to
enable the U.S.
Patent and Trademark Office and the public generally, and especially the
scientists,
engineers, and practitioners in the art who are not familiar with patent or
legal terms or
phraseology, to determine quickly from a cursory inspection the nature and
essence of
the technical disclosure of the application. The abstract is neither intended
to define the
full scope of the application, which is measured by the claims, nor is it
intended to be
limiting as to the scope of the disclosure in any way.
BRIEF DESCRIPTION OF THE DRAWINGS
[0029] All of the figures depict preferred embodiments although
other embodiments
are contemplated, and the present disclosure is not limited to the embodiments
shown.
[0030] FIG. 1A is an illustration of a curved suture needle having a
non-smooth
surface according to certain embodiments of the present disclosure.
[0031] FIG. 1B is a cross-sectional view taken along line 2-2 of the
curved suture
needle shown in FIG. 1A according to certain embodiments of the present
disclosure.
[0032] FIG. 2A is an illustration of a curved suture needle having a
non-smooth
surface and a tapered transition portion according to certain embodiments of
the
present disclosure.
[0033] FIG. 2B is an illustration of a suture needle having a
tapered transition portion
according to certain embodiments of the present disclosure.
[0034] FIGS. 3A-3C are illustrations of alternative cross-sections
of the curved
suture needle according to certain embodiments of the present disclosure.
[0035] FIG. 4 illustrates an alternative arrangement of the non-
smooth surface
according to certain embodiments of the present disclosure.
[0036] FIGS. 5A and 5B are illustrations of a curved suture needle,
shown in partial
cross-section, according to certain embodiments of the present disclosure held
within a
rotational needle driver, wherein FIG. 5A shows the needle in the usual
perpendicular
orientation passing behind the rollers of the driver, and FIG. 5B shows the
needle in the
usual perpendicular orientation passing in front of the rollers of the driver.
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[0037] FIGS. 6A and 6B are illustrations of a curved suture needle
according to
certain embodiments of the present disclosure held within a rotational needle
driver,
wherein FIG. 6A shows the needle in a parallel orientation passing in front of
the rollers
of the driver, and FIG. 6B shows the needle in the an angled orientation
relative to the
rollers and passing in front of the rollers of the driver.
[0038] FIGS. 7A ¨ 7C are illustrations of a curved suture needle
having a tapered
transition portion according to certain embodiments of the present disclosure,
wherein
FIG. 7A shows the rollers of a rotational driver engaging the tapered
transition portion,
and FIG. 7B shows the rollers smoothly transitioning from the tapered
transition portion
over a thread connection portion, and FIG. 7C shown the rollers positioned on
the
curved needle.
[0039] FIG. 8 illustrates an alternative arrangement of the non-
smooth surface
according to certain embodiments of the present disclosure.
DETAILED DESCRIPTION
[0040] To provide an overall understanding of the disclosure,
certain illustrative
embodiments and examples will now be described. However, it will be understood
by
one of ordinary skill in the art that the same or equivalent functions and
sequences may
be accomplished by different embodiments that are also intended to be
encompassed
within the spirit and scope of the disclosure. The compositions, apparatuses,
systems
and/or methods described herein may be adapted and modified as is appropriate
for the
application being addressed and that those described herein may be employed in
other
suitable applications, and that such other additions and modifications will
not depart
from the scope hereof.
[0041] As used in the specification and claims, the singular forms
"a", "an" and "the"
include plural references unless the context clearly dictates otherwise. For
example, the
term "material" may include a plurality of materials unless the context
clearly dictates
otherwise. As used in the specification and claims, singular names or types
referenced
include variations within the family of said name unless the context clearly
dictates
otherwise.
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[0042] Certain terminology is used in the following description for
convenience only
and is not limiting. The words "lower," "upper," "bottom," "top," "front,"
"back," "left,"
"right" and "sides" designate directions in the drawings to which reference is
made, but
are not limiting with respect to the orientation in which the various parts of
the needle or
any assembly of them may be used.
[0043] Swaged suturing needles typically comprise attachment of a
suture thread to
an end of a needle body. These needles have been designed for use with
standard
needle drivers, which clamp the needle between two flat tips and hold the
needle in a
static position.
[0044] A new generation of devices that move the needle through the
tissues by the
coordinated rotation of a plurality of rollers, such as, for example, two,
three, or four
rollers provide a dynamic relationship between the needle and the needle
driver, even
when the needle is clamped between the rollers. One of the great advantages of
this
dynamic relationship is that the needle can be driven in multiple planes of
rotation, such
as perpendicular to the long axis of the driver with the tip pointing up or
down
(standard), parallel with the long axis of the driver with the tip pointing
straight back
towards the back of the device or straight forward away from the device (non-
standard),
and many angles in between. This dynamic relationship is desirable for the
surgeon as
it enables placement of the needle at non-traditional angles, permitting
suturing of
difficult anatomical regions or situations, such as restricted, deep and less
accessible
locations.
[0045] According to certain embodiments, a needle comprising a
needle tip portion
having a needle tip at a distal end for piercing tissue, a straight or curved
trunk portion
having a distal end connected to a proximal end of the needle tip portion; and
a thread
attachment portion connected to a proximal end of the trunk portion for
connecting a
suturing thread, wherein the needle tip portion is formed to become gradually
thicker
from the needle tip to the proximal end thereof, and wherein the trunk portion
is formed
to have a substantially circular cross-section having a non-smooth profile. In
certain
embodiments, the needle may have a smooth profile. In one or more
embodiment(s),
the needle comprises at least one of a circular, an oval, an ellipsoidal, an
oblong, a
semi-circular, a triangular, a square, a rectangular, a pentagonal, a
hexagonal, a
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heptagonal, an octagonal, a nonagonal, a decagonal, or a polygonal having more
than
ten sided, cross-section. In one or more embodiment(s), the suturing needle
comprises
multiple varied cross sections, including any combinations of the foregoing
cross-
sections.
[0046] Some of these suture needles can be used for medical purposes
(e.g.,
suturing). For example, some of these suture needles can be used in
transcatheter
suturing, transcatheter intracardiac (or another body organ) suturing, and
other flexible
platform applications (e.g., endoscopic suturing, colonoscopic suturing). For
example,
rigid shaft embodiments, as commonly used for laparoscopic, video-assisted
thoracoscopic surgery (VATS) and robotic surgery can be used to fundamentally
transform suture-based tissue approximation/anchoring from a laborious task to
a swift
semi-automated or fully-automated endeavor. For example, some of these suture
needles can be used for an open surgery, a minimally invasive surgery, a
laparoscopic
surgery, or an end effector robotic surgery. As such, the some of these suture
needles
can be used for manual surgery or automated surgery. Some examples of
surgeries
where some of these suture needles can be employed include laparoscopic
surgery,
robotic surgery, video-assisted or unassisted thoracoscopic surgery,
arthroscopic
surgery, natural orifice surgery, endoscopic surgery, gynecologic surgery,
cardiac
surgery, colorectal surgery, pulmonary surgery, gastric bypass surgery,
hysterectomy
surgery, dental surgery, urological surgery, brain surgery, or bariatric
surgery, or among
many others in human (e.g., between newborn until 120 years old, male, female)
or
animal (e.g., mammal, birds, fish, land animals) applications.
[0047] Note that some of these suture needles can be employed in
medical or non-
medical settings, whether on an object is animate or inanimate. For example,
the object,
when animate, can include a tissue, an organ, a body part, whether of human or
animal,
or others. For example, the tissue can be a muscle tissue, a bone tissue, a
nerve tissue,
an organ tissue, or others. For example, the object, when inanimate, can
include a
medical device, a prosthesis, an implantable, a machine, a surgical
instrument, or
others. For example, some of the non-medical setting can include garment
making,
fabric stitching, knot applications, sowing, shoe making, or others.
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[0048] Current curved suture needles, which generally have an oval
profile, have not
been designed for use in these new roller needle drivers. As such, they tend
to perform
sub-optimally in these devices. For example, when trying to drive a standard
curved
needle through such a device, the needles may deviate out of the initial
chosen plane of
rotation, often due to the oval shape of the needle. Moreover, it is not
possible to
securely position these needles in a non-standard angle. Accordingly, an
object of the
present disclosure is to provide suture needles that may perform optimally in
roller
needle drivers and may incorporate features that enable multi-planar needle
driving.
[0049] Rotational needle drivers generally comprise an actuator
portion having
linear and rotational motion systems and an interactive portion configured to
interact
with the suture needle. Each interactive portion comprises a first extended
member and
a second extended member which approximate a pair of chopsticks that may be
opened
and closed. Each extended member comprises a main needle-grasping portion
having
grooves, such as grooves 602 on each of a first 600A and second 600B roller as
shown
in FIG. 5A. The suture needles of the present disclosure are designed to
include ridges
that mate with these grooves 602 of the rollers so that a secure connection
between the
needle and the rollers may be achieved. In one or more embodiment, the main
needle
grasping portion has no grooves. In one or more embodiment, the main needle
grasping portion has evenly spaced grooves each at a similar depth. In one or
more
embodiment, the main needle grasping portion has indentations. In one or more
embodiment, the main needle grasping portion has shaped grooves that
substantially
mirror the shape of the needle. In one or more embodiments, the needle
grasping
portion includes a first portion having shaped grooves and a second portion
that is
substantially flat. In one or more embodiments, the needle grasping portion
includes a
first portion having a first shaped grooves and a second portion having a
second
shaped grooves.
[0050] As shown in FIGS. 5A and 5B, the needle may be grasped between the
rollers to position the needle perpendicular to the rollers, passing behind
the rollers of
the driver as in FIG. 5A or in front of the rollers as in FIG. 5B. The unique
arrangement
of ridges on the suture needle further provide for grasping between the
plurality of
rollers at non-standard angles, such as parallel with the rollers as shown in
FIG. 6A or
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even oblique to the rollers as shown in FIG. 6B, or any of a number of angles
therebetween.
[0051] Current swaged suture needles generally include a lip or step-
up in the
transition from the suture thread to the thread attachment connector, and
another lip or
step-up in the transition from the thread attachment component to the needle
body.
Alone or in combination, these transitions pose a problem for the rollers of a
rotational
needle driver, as the suture thread may be damaged by the rollers, or
conversely, the
transitions may damage the rollers of the needle driver. For example, the
rollers may roll
past the thread attachment component of the needle and may clamp down on that
region and damage/cut the suture thread. The present disclosure overcomes
these
deficiencies by incorporating a novel tapered transition portion that provides
a smooth
transition from the suture thread to the needle body. With reference to FIG.
1, a suture
needle 200 of the present disclosure may comprise a tapered transition portion
210.
This protective leading segment immediately follows the distal end of the
trunk portion
204, such as covering the thread attachment component 206 of the needle and
extends
over a proximal portion of the suture thread 208. In certain embodiments,
there is no or
minimal transition between the trunk portion 204 of the needle and the thread
attachment portion 206. In such embodiments, the transition portion 210
provided a
taper from the trunk portion 204 and past the thread attachment portion 206.
In certain
embodiments, the tapered transition portion 210 includes a proximal side that
overlaps
the trunk portion 204 in a direction of the needle tip and includes a distal
side that
extends to a point overlapping the suture to form a taper. In certain
embodiments, the
taper is gradual. In certain embodiments the taper is steep. In certain
embodiments,
the swage is tapered. In certain embodiments, the swage is non-tapered.
[0052] When the suturing procedure begins, the suture needle having
a non-smooth
surface configured to interact with the grooves of the plurality of rollers is
grasped at a
desired angle. The surgeon may press an actuator on the needle driver that
brings the
rollers closer so that they may grasp the needle and may lock the rollers in
position
exerting the necessary force to maintain the needle still. Once the needle is
tightened,
the actuator may create a rotational movement of the rollers, such as shown in
FIG. 7A,
wherein the rollers rotate in directions opposite from each other to affect
movement of
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the needle in either of two directions. Thus, the surgeon may drive the needle
through
the tissue as the rollers rotate. When the desired rotation is completed, the
surgeon
releases the locking mechanism. This method is repeated on the other tissue
that is to
be joined to the tissue already perforated by the needle, and each step above
is
repeated as many times as stitches have to be performed.
[0053] The design of the roller needle driver permits rotation of a
curved suture
needle without requiring a rotational motion of the wrist. Therefore, the
instrument can
be held in a position that may not allow wrist rotation and still carry out
its function. In
some situations, the structures to be sutured lie very deep. Doing surgery on
the
vertebral column of very obese patients is one such situation. For example, if
the dura
mater (a membrane that protects and envelops the spinal cord) is cut it needs
to be
sutured. The dura mater lies within a deep constricted space. In a very obese
patient,
the additional thickness of the adipose (fatty) tissue makes the dura lie even
deeper
from the surface. The surgeon may have to lean towards the patient and rotate
the arm
bearing the needle driver. This is necessary to get his forearm in a vertical
position so
he can maneuver the instrument properly. The needle driver used with a suture
needle
as disclosed herein may be operated in such a position.
[0054] With reference to FIGS. 1A and 1B, a suture needle 200 of the
present
disclosure is shown. The needle 200 generally comprises a needle tip 202 for
piercing a
tissue. Thus, the needle tip 202 is positioned at a distal end of a needle tip
portion 203,
wherein the needle tip portion becomes gradually thicker from the needle tip
to a
proximal end thereof. The needle tip portion may be a tapered tip wherein the
needle
tip portion is round and tapers smoothly to a point. Alternatively, the needle
tip portion
may be triangular as shown in FIG. 1A, and may have a sharpened cutting edge
on the
inside or on the outside, or may have a "trocar point" or "tapercut" whereby
the needle
body is round and tapered, but ends in a small triangular cutting point.
Alternatively, the
needle tip may be a blunt point, such as for suturing friable tissues, or may
have a
needle tip portion that includes "side cutting" or "spatula points" whereby
the needle is
flat on top and bottom with a cutting edge along the front to one side (these
are typically
used for eye surgery).
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[0055] Continuous with the proximal end of the needle tip portion
203 is the trunk
portion 204 having the thread attachment portion 206 positioned at a distal
end thereof.
The needle body 204 is shown to have a curve which may comprise any of several
shapes, such as, for example, half curved or ski, 1/4 circle, % circle, 1/2
circle, such as
shown in the figures, % circle, and compound curve. Alternatively, the needle
body or
trunk portion may be straight, such that the present disclosure may comprise a
straight
needle.
[0056] The material configuring the suture needle is not limited,
and may comprise a
metal or a metal alloy, such as, for example, a biocompatible metal or metal
alloy. In
certain embodiments, the suture needle comprises any of steel wire, a
martensitic
stainless steel, or an austenitic stainless steel. In certain embodiments, the
suture
needle is comprised of a magnetic or magnetizable material. When formed of
steel wire
or martensitic stainless steel, the needle may be hardened by thermal
treatment. Other
processes when forming or finishing the needle may be siliconization, coating
with any
number or combination of biocompatible coating materials or lubrication with
any
number or combination of biocompatible lubricating agents, among other
processes.
[0057] In one or more embodiments, for example, as shown in Fig. 9,
the suture
needle may have an oval cross section that rotates along the length of the
needle, such
that when viewed from the same perspective, the cross section of the suture
needle
located near the proximal end of the needle tip portion 203 is wider from left
to right than
from top to bottom, and the cross section of the suture needle located near
the middle
of the trunk portion 204 is wider from top to bottom than from left to right.
[0058] According to certain embodiments, a suture thread 208 may be
swaged to the
needle 200 by the thread attachment portion 206. Accordingly, the needle is
generally
an atraumatic needle, i.e., eyeless needle, having a suture material or thread
attached
at an end by swaging whereby the suture material is inserted into a channel at
the blunt
end of the needle, such as into the thread attachment portion 206, which is
then
deformed to a final shape to hold the suture and needle together. The needle
may be
permanently swaged to the suture material or may be designed to come off the
suture
material with a sharp straight tug. These "pop-offs" are commonly used for
interrupted
sutures, where each suture is only passed once and then tied.
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[0059] The suture material or thread may be mono-filamentary, i.e.,
formed of a
single filament, or multi-filamentary, i.e., formed from a combination of two
or more
filaments, e.g., three filaments arranged in a braided fashion. The suture
thread has a
length, where that length is typically at least 5 inches, or at least 10
inches, or at least
15 inchers, or at least 20 inches. The suture thread will typically have two
ends, which
may be described as a deployment end and/or a trailing end. In such a case,
the
deployment end of the suture thread is that end that first enters tissue,
adjacent to the
needle, such as connected via the thread attachment portion to the distal end
of the
trunk portion of the needle. Alternatively, the suture material may be looped,
such that
each of the two free ends are connected to the needle by the thread attachment
portion.
[0060] The thread 112 can be a suture, which can be non-absorbable
or absorbable
of various gauges. The thread 112 can include silk, cotton, fabric, nylon,
polyester,
silver, copper, Dacron, rubber, silicon, plain or chromic catgut,
polyglycolide,
polydioxanone, monocryl, polypropylene, triclosan, caprolactone, polymer,
glycolide, 1-
lactide, p-dioxanone, trimethylene carbonate, c-caprolactone, stainless steel,
ceramic,
glass, leather, or other natural or artificial materials. The thread 112 is
solid, but can be
perforated. The thread 112 is internally dense, but can be hollow. The thread
112 can
be rigid, semi-rigid, elastic, resilient, or flexible. For example, the thread
112 can bend
about 90 degrees or less (e.g., inclusively between or about 90, 80, 70, 60,
50, 40, 30,
20, or 10 degrees) or more (e.g., inclusively between or about 90, 100, 110,
120, 130,
140, 150, 160, 170, or 180 degrees). The thread 112 can have a cross-section
that is
closed-shaped (e.g., 0-shape, D-shape, 0-shape, square, rectangle, triangle,
polygon)
or open-shaped (e.g., U-shape, C-shape, V-shape), whether symmetrical or
asymmetrical.
[0061] The suture material or thread may be bioabsorbable, such that
after
introduction into a tissue it is broken down and absorbed by the body.
Typically, the
degradation process is at least partially mediated by, or performed in, a
biological
system. Accordingly, bioabsorbable refers to a chain scission process by which
a
polymer chain is cleaved through various mechanisms, including, for example,
by
chemical reaction (e.g., hydrolysis, oxidation/reduction, enzymatic mechanisms
or a
combination of these) or by a thermal or photolytic process. Bioabsorbable
suture
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material may include polymers such as polyglycolic acid, copolymers of
glycolide and
lactide, copolymers of trimethylene carbonate and glycolide with diethylene
glycol (e.g.,
MAXON TM, Tyco Healthcare Group), terpolymer composed of glycolide,
trimethylene
carbonate, and dioxanone (e.g., BIOSYNTIglycolide (60%), trimethylene
carbonate
(26%), and dioxanone (14%)], Tyco Healthcare Group), copolymers of glycolide,
caprolactone, trimethylene carbonate, and lactide (e.g., CAPROSYN TM, Tyco
Healthcare Group). In certain embodiments, the bioabsorbable suture material
may
comprise or include any other polymer useful for suturing applications that
currently
exists or that may be developed in the future.
[0062] Alternatively, the suture material or thread may be non-
degradable, such that
it is not degraded by chemical, thermal, or photolytic process. Non-degradable
suture
material includes polyamide (also known as nylon, such as nylon 6 and nylon
6.6),
polyester (e.g., polyethylene terephthlate), polytetrafluoroethylene (e.g.,
expanded
polytetrafluoroethylene), polyether-ester such as polybutester (block
copolymer of
butylene terephthalate and polytetra methylene ether glycol), polyurethane,
metal
alloys, metal (e.g., stainless steel wire), polypropylene, polyethelene, silk,
and cotton.
Sutures made of non-degradable suture material are particularly suitable for
applications in which the suture is meant to remain permanently or is meant to
be
physically removed from the body. In certain embodiments, the non-degradable
suture
material may comprise or include any other polymer useful for suturing
applications that
currently exists or that may be developed in the future.
[0063] The suture material or thread may comprise a coating or agent
applied to a
surface thereof that may affect would healing, such as a coating material,
wound
healing agent, antimicrobial agent, antibacterial agent, growth factor,
adhesive, sealant,
blood product, blood component, preservative, anti-adhesive, protein,
polysaccharide,
peptide, genetic material, viral vector, nucleic acid, nucleotide, plasmid,
lymphokine,
radioactive agent, metal, alloy, salt, growth factor, growth factor
antagonist, cell,
hydrophobic agent, hydrophilic agent, immunological agent, anti-colonization
agent, and
combinations thereof. The suture material or thread may comprise a coating or
agent
applied to a surface thereof that may enhance the surgeon's ability to
accurately suture,
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such as colorants, dyes, ultraviolet absorbers, ultraviolet stabilizers,
photochromic
agents, diagnostic agent, imaging agent, radiopaque agent, or combinations
thereof.
[0064] The suture material or thread may have a diameter indicated
by a cross-
sectional dimension (see a of FIG. 1B). This diameter may be determined at a
location
along the suture where there are either no barbs, or the barbs that are
present are
pushed against the suture body so that they are flush with the surface of the
suture
body. The suture may have no barbs or may have barbs along all or only a
portion of
the suture length. According to certain embodiments, the suture may have at
least one
barbed region positioned distal from the thread attachment portion. Such
positioning
may allow the presently disclosed suture needle to be backed out of a suture
site,
wherein the swaged suture material adjacent the needle would not have barbs
and
would easily slide back through the tissue. In some embodiments the tapered
transition
portion covers the barbs on the suture, thereby allowing the suture needle to
be backed
out of the suture sight. More distally located barbed suture may remain
securely in
place once positioned in the tissue.
[0066] The suture may have a generally circular cross-sectional
shape, or may have
a non-circular shape, e.g., polygonal such as 3-sided (triangular), or 4-, 5-
or 6-sided
(hexagonal) sided. The cross section of the suture body may have a circular,
an oval,
an ellipsoid, an oblong, a semi-circular, a triangular, a square, a
rectangular, a
pentagonal, a hexagonal, a heptagonal, an octagonal, a nonagonal, a decagonal,
or a
polygonal having more than ten sided, cross-section or appearance.
[0066] Suture sizing is based upon diameter. The United States
Pharmacopeia
(USP") designation of suture size runs from 0 to 7 in the larger range and 1-0
to 11-0 in
the smaller range; in the smaller range, the higher the value preceding the
hyphenated
zero, the smaller the suture diameter. Under the USP nomenclature system, the
actual
diameter of a suture will depend on the suture material, so that, by way of
example, a
suture of size 5-0 and made of collagen will have a diameter of 0.15 mm, while
sutures
having the same USP size designation but made of a synthetic absorbable
material or a
non-absorbable material will each have a diameter of 0.1 mm. The selection of
suture
size for a particular purpose depends upon factors such as the nature of the
tissue to be
sutured and the importance of cosmetic concerns; while smaller sutures may be
more
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easily manipulated through tight surgical sites and are associated with less
scarring, the
tensile strength of a suture manufactured from a given material tends to
decrease with
decreasing size. It is to be understood that the suture materials for use with
the suture
needles disclosed herein include without limitation 7, 6, 5, 4, 3, 2, 1, 0, 1-
0, 2-0, 3-0, 4-
0, 5-0, 6-0, 7-0, 8-0, 9-0, 10-0 and 11-0. It is to be understood that a
variety of suture
lengths may be used with the suture needles described herein.
[0067] The needle body may have any profile known in the art, such
as circular, oval,
triangular, and the like. The needle body may have a smooth surface, such that
there
are no sharp edges. According to certain embodiments, the needle body may be a
non-
smooth or non-circular/oval profile. For example, when trying to drive a
needle through
a tissue using a rotational needle drive, a smooth surface of the needle body
on a
circular or oval profile may allow the needle to deviate out of an initial
chosen plane of
rotation.
[0068] With reference to FIG. 1B, a cross-sectional view of the
curved trunk portion
taken along line 2-2 of FIG. 1A shows this region to have a circular shape
with a non-
smooth profile. This non-smooth profile can be achieved by forming
indentations 222 in
the outer circumferential periphery of the trunk portion. As shown, these
indentations
may be evenly spaced, and may form protrusions 220, such as the smooth convex
protrusions shown in FIG. 1B.
[0069] These indentations 222 and/or protrusions 220 create
longitudinal ridges
along the length of the trunk portion 204 and may be uniquely designed and
configured
to fit within the grooves of the rollers of a rotational needle driver. That
is, these ridges
may fit within the grooves of the rollers of the needle driver and act like
rails to secure
the orientation of the needle in the groove while the needle is being driven
by the
rotation of the rollers. Because the needle 200 has ridges evenly spaced about
its
round cross-section, the needle can be placed in any of a number of angles on
the
rollers. See for example the rollers (600A, 600B) shown in FIGS. 5A-7B that
are
grasping a needle along the trunk portion 204, wherein the ridges
(indentations 222 and
protrusion 220) match the grooves 602 of the plurality of rollers independent
of the
orientation of the needle. In certain embodiments, the ridges are unevenly
spaced. In
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certain embodiments, the ridges have different heights. In certain
embodiments, the
ridges have different orientations.
[0070] With reference to FIG. 1B, the depth of the indentations 222
(difference in
diameter a and b of the trunk portion 204), and their spacing about the
circumference of
the trunk portion defines the ridges. These dimensions may be selected so that
the
ridges match the depth and spacing of grooves on the rollers of a rotational
needle
driver (such as shown in FIGS. 5A-7B). The specific design shown in FIG. 1B is
exemplary only, as many other designs and configurations are possible, such as
shown
in FIGS. 3A-3C which include different numbers of indentations and thus
different
numbers of convex protrusions (ridges). Moreover, while the protrusions or
ridges 220
are shown to have a generally convex shape without any sharp angles (i.e., no
pointed
edges), other configurations are possible and within the scope of the present
disclosure,
such as, for example, pointed ridges, flat ridges or stepped ridges. The
indentations
222 may also have different shapes, such as, for example, notched, flat,
rounded,
curved, V-shaped, U-shaped, or stepped
[0071] The ridges formed on the suture needle generally extend along
a full
longitudinal length of the trunk portion 204, as shown in FIG. 1A. According
to certain
embodiments, the indentations 222 may be formed about a circumference of the
trunk
portion at an angle, thus forming ridges (i.e., protrusions 220) that may
spiral about the
outer circumference of the trunk portion 204 of the needle 200. The angle may
be
selected so that the ridges have a right-handed or left-handed spiral.
Moreover, as
shown in FIG. 4, the angle of the ridges may be changed one or more times
along a
length of the trunk portion 504. For example, the ridges may have a right-
handed angle
(504a), no angle (504b), or a left-handed angle (504c). The specific angle,
size of the
angled region, and placement thereof may be selected based on suture procedure
requirements.
[0072] In certain embodiments, for example, as shown in FIG. 8, the
suture needle
100 includes indentations and/or ridges 110 that extend circumferentially
around the
suture needle body, such that they provide improved traction for the rollers
of the needle
driver to move the suture needle through dense, compact, or hard material. In
certain
embodiments, the circumferential ridges 110 may be closely spaced one from the
other.
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In certain embodiments, the circumferential ridges 110 may be spaced apart one
from
the other. In certain embodiments, the distance between the circumferential
ridges 110
is fixed. In certain embodiments, the distances between circumferential ridges
110
varies from ridge to ridge. In certain embodiments, the distances between
circumferential ridges 110 varies according to a predetermined pattern,
formula, or
algorithm. In certain embodiments, one or more of the rollers of the needle
driver
include indentations or ridges that run from a proximal end to a distal end of
one or
more of the grooves of the rollers. In certain of the embodiments, the
indentations or
ridges in the grooves of the rollers mate or interleave with the
circumferential ridges 110
or indentations on the suture needle. This provides the rollers with improved
traction for
the rollers of the needle driver to move the suture needle through dense,
compact, or
hard material.
[0073] In certain embodiments, the suture needle includes ridges
that extend along
only a portion of the needle trunk. In certain embodiments, the suture needle
includes
ridges that begin at a first portion and end at a second portion of the needle
trunk. In
certain embodiments, the suture needle includes multiple discontinuous areas
having
ridges with intervening non-ridged areas. In certain embodiments, the suture
needle
includes certain areas with at least one of ridges, a groove surface, a
roughened
surface, a smooth surface, a bumpy surface, a ribbed surface, a tacky surface,
or a
polished surface. In certain embodiments, the suture needle includes certain
areas with
at least one of a ridged surface, a grooved surface, a roughened surface, a
smooth
surface, a bumpy surface, a ribbed surface, a tacky surface, or a polished
surface, and
other areas with at least one different surface. In certain embodiments, the
ridged and
non-ridged sections, or any combinations thereof may each be of any particular
length,
width, order, or orientation. In certain embodiments, the ridged surface, the
grooved
surface, the roughened surface, the smooth surface, the bumpy surface, the
ribbed
surface, the tacky surface, or the polished surface sections, or any
combinations thereof
may each be of any particular length, width, order, or orientation. In certain
embodiments, there may be more than one type of non-ridged surface, such as,
for
example, a ridged surface, a grooved surface, a roughened surface, a smooth
surface,
a bumpy surface, a ribbed surface, a tacky surface, or a polished surface. For
example,
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you can have ridged sections, smooth sections and otherwise textured non-
ridged
sections combined in the same needle trunk for any type of application.
[0074] In certain embodiments, a suture needle may comprise a smooth
tip section,
ridged body and textured-non-ridged portion near the swage end that could
induce
some slight vibration captured by a robotic needle driver to improve haptic
feedback to
the surgeon on when to pull the needle out of the tissue to minimize tissue
trauma,
particularly in regions where tissue visibility or maneuverability is quite
limited or tissues
are very prone to tearing if the needle is pulled from the tissues too soon.
[0075] With reference to FIG. 1A, when used with a rotational needle
driver, such as
discussed above, the rollers may roll past the thread attachment portion 206
of the
needle 200 and may clamp down on that region and damage/cut the suture thread.
Thus, according to certain embodiments, a non-smooth surface suture needle of
the
present disclosure may comprise a tapered transition portion 310, such as
shown in
FIG. 2A. This is similarly shown for a smooth surfaced suture needle of FIG.
2B, having
a tapered transition portion 310. This protective leading segment immediately
follows
the distal end of the trunk portion 204 of the needle, such as covering the
thread
attachment portion 206 of the needle, and extends over a proximal portion of
the suture
material. In certain embodiments, there is no or minimal transition between
the trunk
portion 204 of the needle and the thread attachment portion 206. In such
embodiments,
the transition portion 310 provides a taper from the trunk portion 204 and
past the
thread attachment portion 206. In certain embodiments, the tapered transition
portion
310 includes a proximal side that overlaps the trunk portion 204 in a
direction of the
needle tip and includes a distal side that extends to a point overlapping the
suture to
form a taper. In certain embodiments, the taper is gradual. In certain
embodiments, the
taper is steep. In certain embodiments, the swage is tapered. In certain
embodiments,
the swage is non-tapered.
[0076] The tapered transition portion 310 may extend over the suture
material a
distance from the end of the trunk portion 204 of the needle, such as from
about 0.1 cm
up to about 10 cm, such as about 0.1 cm, about 0.2 cm, about 0.3 cm, about 0.4
cm,
about 0.5 cm, about 0.6 cm, about 0.7 cm, about 0.8 cm, about 0.9 cm, about 1
cm,
about 2 cm, about 3 cm, about 4 cm, about 5 cm, about 6 cm, about 7 cm, about
8 cm,
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about 9 cm, about 10 cm, about 15 cm, about 20 cm, or any distance in between,
or
even greater, such as up to about 20 cm. Moreover, the tapered transition
portion 310
may be formed of a flexible material that may assist in loading the needle
onto the
needle driver, but may have more rigidity than the suture material, such as to
aid in
suture management during knot tying. The length of the tapered transition
portion 310
may be determined by the optimum balance between the minimal length needed by
the
surgeon to grab the needle by the "ramp" when inserting it or withdrawing it
to a surgical
site, such as through a laparoscopic port, and the maximal length that can
feasibly allow
tapering and enough flexibility to go through tissue following the needle path
without
causing tissue trauma.
[0077] The tapered transition portion 310 may be a cyanoacrylate or
another suitable
coating (or filament) material, such as, for example, another biocompatible
material, that
may be built up from a diameter of the suture material 208 to a diameter of
the trunk
portion 204 of the needle 200'. The tapered transition portion 310 may be
formed by a
shrink-wrapped procedure wherein a preform of the tapered region is positioned
over
the suture thread and swage to abut an end of the trunk portion of the needle,
and heat
may be applied to form the preform on the needle, with some sort of
compression to
ensure a smooth transition from the ramp to the suture, thus forming the
tapered
transition portion 310. As such, this protective segment or tapered transition
portion
310 may be shaped as a "conical ramp" that allows the rollers to be rolled
from the
tapered transition portion 310 "up the ramp" in a continuous rolling motion
until reaching
the trunk portion 204 of the needle 200' without hitting the blunt swage end
of the
needle, and thus avoiding potential damage to the needle, rollers and/or
suture material.
In certain embodiments, the tapered transition portion may comprise a magnetic
material or a magentizable material. In certain embodiments, the suture
material may
comprise a magnetic material or a magnetizable material.
[0078] This creates a procedural benefit and efficiency by loading
the needle onto
the needle driver to a position ready for suturing all in a single step, as
shown in FIGS.
7A and 7B. The rollers 600A and 600B may be closed over the suture material
208 and
may rotate in opposite directions (x1 and x2, respectively) to advance the
needle
forward, shown as the transition from the needle position in FIG. 7A to FIG.
7C. As the
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needle advances between the rollers of the needle driver, the rollers smoothly
advance
the needle from the suture material to the tapered transition portion 310
(FIG. 7A).
Without opening the rollers, the rollers may continue to rotate to advance the
needle
along the tapered transition portion 310 over the thread attachment component
206
(FIG. 7A).
[0079] In the absence of the tapered transition portion 310, this
would represent a
step or lip on the needle that may be damaged by the rollers, or conversely,
that may
damage the rollers. Accordingly, in the absence of the tapered transition
portion 310,
the clinician would have to use a grasper to hold/stabilize the needle, then
open the
needle driver to release the suture it was grasping during needle insertion
and then
grasp the needle with the needle driver once positioned over the needle body
in
preparation for suturing. In a laparoscopic setting each of these steps may
require time,
effort, coordination and maybe even repetition due to the lack of depth
perception (2D
visualization systems used mostly) and decreased dexterity, fulcrum effect of
port, etc.
Finally, as shown in FIG. 7C, the rotation of the rollers advances the needle
so that it is
positioned between the rollers and properly loaded for suturing without ever
opening the
rollers. These motions may be reversed to unload the needle, such as to remove
the
needle from a suture site (e.g., from the abdomen or from a laparoscopic
surgical site).
[0080] Features or functionality described with respect to certain
example
embodiments may be combined and sub-combined in and/or with various other
example embodiments. Also, different features and/or elements of example
embodiments, as disclosed herein, may be combined and sub-combined in a
similar
manner as well. Further, some example embodiments, whether individually and/or
collectively, may be components of a larger system, wherein other procedures
may take
precedence over and/or otherwise modify their application. Additionally, a
number of
steps may be required before, after, and/or concurrently with example
embodiments, as
disclosed herein. Note that any and/or all methods and/or processes, at least
as
disclosed herein, can be at least partially performed via at least one entity
or actor in
any manner.
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[0081] As used herein, a term "about" or "substantially" refers to a
+/- 10% variation
from a nominal value/term. Such variation is always included in any given
value/term
provided herein, whether or not such variation is specifically referred
thereto.
[0082] In particular, a suture needle 200 can be used for an open
surgery, a
minimally invasive surgery, a laparoscopic surgery, or an end effector robotic
surgery.
As such, the suture needle 200 can be used for manual surgery or automated
surgery.
Some examples of surgeries where the suture needle 200 can be employed include
laparoscopic surgery, robotic surgery, video-assisted or unassisted
thoracoscopic
surgery, arthroscopic surgery, natural orifice surgery, endoscopic surgery,
gynecologic
surgery, cardiac surgery, colorectal surgery, pulmonary surgery, gastric
bypass surgery,
hysterectomy surgery, dental surgery, urological surgery, brain surgery, or
bariatric
surgery, or among many others in human (e.g., between newborn until 120 years
old,
male, female) or animal (e.g., mammal, birds, fish, land animals)
applications. However,
note that the suture needle 200 can also be applied to non-medical
applications, such
as garment making, fabric stitching, knot applications, sowing, shoe making,
or others.
[0083] Any component described herein can include a material
suitable for a medical
use. The material can be, flexible, elastic, or resilient. The material can be
suitable to be
disinfected, sterilized, or sanitized, which can be with a hot steam, an
autoclave, or
others. For example, the material can include plastic, metal, rubber, shape
memory,
fabric, foam, or others.
[0084] The device and system of the present disclosure has been
described with
specific reference to certain drawings and various embodiments, but may,
however, be
embodied in many different forms and should not be construed as necessarily
being
limited to only embodiments disclosed herein. Rather, these embodiments are
provided
so that this disclosure is thorough and complete, and fully conveys various
concepts of
this disclosure to skilled artisans.
[0085] Note that various terminology used herein can imply direct or
indirect, full or
partial, temporary or permanent, action or inaction. For example, when an
element is
referred to as being "on," "connected" or "coupled" to another element, then
the element
can be directly on, connected or coupled to the other element or intervening
elements
can be present, including indirect or direct variants. In contrast, when an
element is
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referred to as being "directly connected" or "directly coupled" to another
element, there
are no intervening elements present.
[0086] Likewise, as used herein, a term "or" is intended to mean an
inclusive "or"
rather than an exclusive "or." That is, unless specified otherwise, or clear
from context,
"X employs A or B" is intended to mean any of the natural inclusive
permutations. That
is, if X employs A; X employs B; or X employs both A and B, then "X employs A
or B" is
satisfied under any of the foregoing instances.
[0087] Similarly, as used herein, various singular forms "a," "an"
and "the" are
intended to include various plural forms as well, unless context clearly
indicates
otherwise. For example, a term "a" or "an" shall mean "one or more," even
though a
phrase "one or more" is also used herein.
[0088] Moreover, terms "comprises," "includes" or "comprising,"
"including" when
used in this specification, specify a presence of stated features, integers,
steps,
operations, elements, or components, but do not preclude a presence and/or
addition of
one or more other features, integers, steps, operations, elements, components,
or
groups thereof. Furthermore, when this disclosure states that something is
"based on"
something else, then such statement refers to a basis which may be based on
one or
more other things as well. In other words, unless expressly indicated
otherwise, as used
herein "based on" inclusively means "based at least in part on" or "based at
least
partially on."
[0089] Additionally, although terms first, second, and others can be
used herein to
describe various elements, components, regions, layers, or sections, these
elements,
components, regions, layers, or sections should not necessarily be limited by
such
terms. Rather, these terms are used to distinguish one element, component,
region,
layer, or section from another element, component, region, layer, or section.
As such, a
first element, component, region, layer, or section discussed below could be
termed a
second element, component, region, layer, or section without departing from
this
disclosure.
[0090] Also, unless otherwise defined, all terms (including
technical and scientific
terms) used herein have the same meaning as commonly understood by one of
ordinary skill in an art to which this disclosure belongs. As such, terms,
such as those
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defined in commonly used dictionaries, should be interpreted as having a
meaning that
is consistent with their meaning in a context of a relevant art and should not
be
interpreted in an idealized or overly formal sense unless expressly so defined
herein.
[0091] In addition, features described with respect to certain
example embodiments
may be combined in or with various other example embodiments in any
permutational
or combinatory manner. Different features or elements of example embodiments,
as
disclosed herein, may be combined in a similar manner. The term "combination",
"combinatory," or "combinations thereof" as used herein refers to all
permutations and
combinations of the listed items preceding the term. For example, "A, B, C, or
combinations thereof" is intended to include at least one of: A, B, C, AB, AC,
BC, or
ABC, and if order is important in a particular context, also BA, CA, CB, CBA,
BCA, ACB,
BAC, or CAB. Continuing with this example, expressly included are combinations
that
contain repeats of one or more item or term, such as BB, AAA, AB, BBC,
AAABCCCC,
CBBAAA, CABABB, and so forth. The skilled artisan will understand that
typically there
is no limit on the number of items or terms in any combination, unless
otherwise
apparent from the context.
[0092] Although preferred embodiments have been depicted and
described in detail
herein, skilled artisans know that various modifications, additions,
substitutions and the
like can be made without departing from spirit of this disclosure. As such,
these are
considered to be within the scope of the disclosure, as defined in the
following claims.
26
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