Note: Descriptions are shown in the official language in which they were submitted.
1
PARTIALLY ASSEMBLED KNOTLESS SUTURE CONSTRUCT
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application claims benefit to U.S. Provisional Application
Serial No.
62/580,218, filed November 1, 2017, entitled "PARTIALLY ASSEMBLED KNOTLESS
SUTURE CONSTRUCT".
BACKGROUND
[0002] Various injuries include separation of soft tissue from one or
more bones and/or
separation of bones from normally anatomical correct positioning. Maintaining
the bones in the
correct anatomical positions during healing is important to provide proper
soft tissue
reattachment and proper bone healing. For example, during syndesmosis repair,
a first bone and
a second bone must be maintained in a fixed position to allow the connective
tissue to refuse.
[0003] Current suture systems include a suture anchor and one or more
knots for
maintaining sutures in a fixed position. Knots formed in the sutures can cause
irritation during
healing and may be subject to tearing due to friction or other forces applied
to the knot. Current
systems further require surgeons to form knots during surgery. Such systems
are prone to failure
and increase time of surgery.
SUMMARY
[0004] In various embodiments, a method is disclosed. The method includes
a step of
forming a bone tunnel through a first bone and a second bone. A partial
anchoring construct is
inserted through the bone tunnel. The partial anchoring construct includes a
first flexible strand
defining a first adjustable loop and a first anchoring element coupled to a
first end of the first
adjustable loop. A second end of the first adjustable loop is coupled to a
first pull-through
strand. A second anchoring element is coupled to the second end of the first
adjustable loop after
the first adjustable loop is inserted through the bone tunnel by the first
pull-through strand. The
length of the first adjustable loop is adjusted to position the first bone and
the second bone in a
predetermined spacing.
Date Recue/Date Received 2021-08-09
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[0005] In various embodiments, a system is disclosed. The system includes
a first
flexible strand defining a first adjustable loop extending between a first end
and a second end.
The first flexible strand defines a first strand passage and a second strand
passage. The first
strand passage and the second strand passage have a predetermined spacing.
Each of the first
strand passage and the second strand passage are sized and configured to
receive a portion of the
first flexible strand therethrough. A first anchor is coupled to the first end
of the first adjustable
loop. A first pull-through strand is coupled to the first adjustable loop
defined by the first
flexible strand. The pull-through strand is configured to pass the first
flexible strand through a
bone tunnel formed in a first bone and a second bone.
[0006] In various embodiments, a system is disclosed. The system includes
a partial
anchoring construct. The partial anchoring construct includes a first flexible
strand defining a
first adjustable loop extending between a first end and a second end. The
first flexible strand
defines a first strand passage and a second strand passage. The first strand
passage and the
second strand passage have a predetermined spacing. Each of the first strand
passage and the
second strand passage are sized and configured to receive a portion of the
first flexible strand
therethrough. A first anchor includes a base and an extension extending from a
first portion of
the base to a second portion of the base to define a strand channel between
the extension and the
base. The first anchor is coupled to the first end of the first adjustable
loop by passing the first
flexible strand through the strand channel. A pull-through strand defines a
loop extending
through the first adjustable loop of the first flexible strand. The pull-
through strand is configured
to pass the first flexible strand through a bone tunnel formed in a first bone
and a second bone.
The system further includes a second anchor configured to be coupled to the
second end of the
first adjustable loop after insertion of the first flexible strand through the
bone tunnel.
[0007] In various embodiments, a method is disclosed. The method includes
a step of
forming a bone tunnel through a first bone and a second bone. A bone plate is
coupled to the
first bone by inserting at least one plate anchor through an anchor hole
defined in the bone plate.
The bone plate defines a construct hole and is coupled to the first bone such
that the construct
hole is concentric with the bone tunnel. A partial anchoring construct is
inserted through the
construct hole and the bone tunnel. The partial anchoring construct includes a
first flexible
Date Recue/Date Received 2021-08-09
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strand defining a first adjustable loop and a first anchoring element coupled
to a first end of the
first adjustable loop. A second end of the first adjustable loop is coupled to
a first pull-through
strand. The pull-through strand is configured to be inserted through the
construct hole and the
bone tunnel prior to the first adjustable loop. A second anchoring element is
coupled to the
second end of the first adjustable loop after the first adjustable loop is
inserted through the bone
tunnel by the first pull-through strand. The length of the first adjustable
loop is adjusted to
position the first bone and the second bone in a predetermined spacing.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] The features and advantages of the present invention will be more
fully disclosed
in, or rendered obvious by the following detailed description of the preferred
embodiments,
which are to be considered together with the accompanying drawings wherein
like numbers refer
to like parts and further wherein:
[0009] FIG. 1 illustrates a surgical site including an anchoring system
configured to
position a first bone and a second bone at a predetermined spacing, in
accordance with some
embodiments.
[0010] FIG. 2 illustrates the surgical site of FIG. 1 including a partial
anchoring construct
of the anchoring system having an adjustable loop inserted through the first
bone and the second
bone, in accordance with some embodiments.
[0011] FIG. 3 illustrates the surgical site of FIG. 2 having a first
anchor and a second
anchor coupled to the partial anchoring construct, in accordance with some
embodiments.
[0012] FIG. 4 illustrates a partial anchoring construct including a first
strand passage and
a second strand passage, in accordance with some embodiments.
[0013] FIG. 5 illustrates a flexible strand including a first woven
passage and a second
woven passage, in accordance with some embodiments.
[0014] FIG. 6 is a flowchart illustrating a method of positioning a first
bone and a second
bone in at a predetermined spacing, in accordance with some embodiments.
Date Recue/Date Received 2021-08-09
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[0015] FIG. 7 illustrates a surgical site having an anchoring system
including a bone
plate and a partial anchoring construct having first and second adjustable
loops configured to be
inserted through a first bone and a second bone, in accordance with some
embodiments.
[0016] FIG. 8 illustrates the surgical site of FIG. 7 having the
adjustable loop inserted
through the first bone and the second bone, in accordance with some
embodiments.
[0017] FIG. 9 illustrates the surgical site of FIG. 8 having a first
anchor and a second
anchor coupled to the partial anchoring construct, in accordance with some
embodiments.
[0018] FIG. 10 illustrates the surgical site of FIG. 7 having the
anchoring system inserted
through the second bone prior to insertion through the first bone, in
accordance with some
embodiments.
[0019] FIG. 11 illustrates the surgical site of FIG. 10 having a first
anchor abutting a
second bone and a second anchor abutting a first bone, in accordance with some
embodiments.
[0020] FIG. 12 is a flowchart illustrating a method of maintaining a
first bone and a
second bone in a correct anatomical position, in accordance with some
embodiments.
[0021] FIG. 13 illustrates a surgical site having an anchoring system
including a partial
anchoring construct having a first adjustable loop and a second adjustable
loop each coupled to a
guide element, in accordance with some embodiments.
[0022] FIG. 14 illustrates a partial anchoring construct including a
first independent
adjustable loop and a second independent adjustable loop, in accordance with
some
embodiments.
[0023] FIG. 15 illustrates the partial anchoring construct of FIG. 14
inserted through a
bone tunnel defined in a first bone and a second bone and having a second
anchor coupled to a
second end of each of the first independent adjustable loop and the second
independent
adjustable loop, in accordance with some embodiments.
[0024] FIG. 16 illustrates a flat button, in accordance with some
embodiments.
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[0025] FIG. 17 illustrates a knot capsule, in accordance with some
embodiments.
DETAILED DESCRIPTION
[0026] This description of the exemplary embodiments is intended to be
read in
connection with the accompanying drawings, which are to be considered part of
the entire
written description. In the description, relative terms such as "lower,"
"upper," "horizontal,"
"vertical,", "above," "below," "up," "down," "top," "bottom," "proximal,"
"distal," "superior,"
"inferior," "medial," and "lateral" as well as derivative thereof (e.g.,
"horizontally,"
"downwardly," "upwardly," etc.) should be construed to refer to the
orientation as then described
or as shown in the drawing under discussion. These relative terms are for
convenience of
description and do not require that the apparatus be constructed or operated
in a particular
orientation. Terms concerning attachments, coupling and the like, such as
"connected," refer to a
relationship wherein structures are secured or attached to one another either
directly or indirectly
through intervening structures, as well as both movable or rigid attachments
or relationships,
unless expressly described otherwise. Like elements have been given like
numerical designations
to facilitate an understanding of the present subject matter.
[0027] As used herein, the term "substantially" denotes elements having a
recited
relationship (e.g., parallel, perpendicular, aligned, etc.) within acceptable
manufacturing
tolerances. For example, as used herein, the term "substantially parallel" is
used to denote
elements that are parallel or that vary from a parallel arrangement within an
acceptable margin of
error, such as +/- 5 , although it will be recognized that greater and/or
lesser deviations can exist
based on manufacturing processes and/or other manufacturing requirements.
[0028] In various embodiments, a system for syndesmotic repair is
disclosed. The
system includes a partial anchoring construct having a first flexible strand
defining at least one
flexible loop. The adjustable loop is configured to be inserted through a bone
tunnel defined in a
first bone and a second bone. In some embodiments, the first flexible strand
includes a first
strand passage and a second strand passage. A first anchor is coupled to a
first end of the
adjustable loop. The first anchor is configured to couple the first end of the
adjustable loop to an
outer sursurface of the first bone at a first end of the bone tunnel. The
system further includes a
Date Recue/Date Received 2021-08-09
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second anchor configured to be coupled to a second end of the adjustable loop
after the second
end is passed through the bone tunnel. The adjustable loop is tightened prior
to position the first
bone and the second bone in a predetermined spacing and maintain the first
bone and the second
bone within a predetermined range of movement.
[0029] FIG. 1 illustrates a surgical site 100 including a first bone 102
and a second bone
104, in accordance with some embodiments. A syndesmotic anchoring system 2 is
configured to
position the first bone 102 and a second bone 104 at a predetermined spacing
and/or maintain the
first bone 102 and the second bone 104 within a predetermined range of motion.
The anchoring
system 2 includes a partial anchoring construct 30 including a flexible strand
4 defining an
adjustable loop 6 extending from a first end 8 to a second end 10. The
flexible strand 4 can
include any suitable material, such as, for example, one or more sutures,
ribbons, ropes, etc. The
adjustable loop 6 is configured to extend at least from a first end 106a of
the bone tunnel 106 to a
second end 106b. Although embodiments are discussed herein having a
syndesmotic anchoring
system 2 coupled to a first bone 102 and a second bone 104, it will be
appreciated that the
syndesmotic anchoring systems 2 disclosed and described herein can be used
with any number of
bones, including, for example, one bone, two bones, three bones, etc., and are
within the scope of
this disclosure. For example, the anchoring system of the present disclosure
may be used in one
bone, when the bone has at least one fracture and it is necessary to maintain
the bones in a
predetermined alignment or range of motion.
[0030] In some embodiments, the partial anchoring construct 30 includes a
first anchor
14 coupled to a first end 8 of the adjustable loop 6. The first anchor 14 can
include any suitable
anchor, such as a button, a knot capsule, a fastener, and/or any other
suitable anchor. For
example, in some embodiments, the first anchor 14 includes a flat button
having one or more
openings configured to receive a portion of a flexible loop 6 therethrough and
sized and
configured to abut the first bone 102. The first anchor 14 retains the first
end 8 of the adjustable
loop 6 at a first end 106a of the bone tunnel 106. A flat button is described
in greater detail
below with reference to FIG. 15. In other embodiments, the first anchor 14
includes a base and
extension extending from the base. The extension defines a strand passage
sized and configured
to receive the flexible strand 4 therethrough. In some embodiments, the
extension is sized and
Date Recue/Date Received 2021-08-09
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configured to be at least partially inserted into the bone tunnel 106. A knot
capsule having a
base and an extension is described in greater detail below with reference to
FIG. 16.
[0031] A first free end 20a and a second free end 20b of the flexible
strand 4 extend from
one end 8, 10 of the adjustable loop 6. The free ends 20a, 20b are configured
to shorten (e.g.,
tighten) and/or lengthen (e.g., loosen) the adjustable loop 6. In various
embodiments, the first
free end 20a and the second free end 20b are configured to extend from a first
end 106a of the
bone tunnel 106, extend from a second end 106b of the bone tunnel 106, and/or
extend from both
the first end 106a and the second end 106b of the bone tunnel 106.
[0032] In some embodiments, a pull-through strand 24 is coupled to the
second end 8 of
the adjustable loop 16. The pull-through strand 24 is sized and configured to
be inserted through
the bone tunnel 106. The pull-through strand 24 can include any suitable
material, such as, for
example, one or more sutures, ribbons, ropes, etc. The pull-through strand 24
is coupled to the
second end 10 of the adjustable loop 6, for example, by tying the pull-through
strand 24 to the
adjustable loop 6, by looping the pull-through strand 24 through the
adjustable loop 6, and/or any
other suitable coupling method. In some embodiments, the pull-through strand
24 is omitted.
[0033] In some embodiments, a guide element 26 is coupled to the pull-
through strand
24. The guide element 26 is sized and configured to be inserted through the
bone tunnel 106.
The guide element 26 is resilient and is configured to be inserted through the
bone tunnel 106
without deforming. For example, the guide element 26 can include a needle,
stent, guide wire, k-
wire, and/or any other suitable guide element 26. In some embodiments, the
guide element 26
can include a self-drilling guide element configured to form the bone tunnel
106 simultaneously
with insertion of the guide element 26 through the first bone 102 and the
second bone 104, such
as a k-wire. In some embodiments, the pull-through strand 24 is omitted and
the guide element
26 is directly coupled to the second end 10 of the adjustable loop 6.
[0034] In some embodiments, the syndesmotic anchoring system 2 includes a
second
anchor 16. The second anchor 16 can include a button anchor, a knot capsule, a
fastener, and/or
any other suitable anchor. For example, in some embodiments, the second anchor
16 includes a
Date Recue/Date Received 2021-08-09
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button anchor having one or more openings configured to receive a portion of a
flexible loop 6
therethrough and sized and configured to abut the second bone 104 to retain
the second end 10 of
the adjustable loop 6 at a second end 106b of the bone tunnel 106. The second
anchor 16
couples the second end 10 of the adjustable loop 6 to the second bone 104 at a
second end of the
bone tunnel 106. The second anchor 16 can be coupled to the second end 10 of
the adjustable
loop 6 prior to, during, and/or after the adjustable loop 6 has been shortened
(e.g., tightened).
[0035] FIG. 2 illustrates the partial anchoring construct 30 after being
inserted through
the first bone 102 and the second bone 104, in accordance with some
embodiments. The guide
element 26 (and a pull-through suture 24, if present) is disconnected after
insertion through the
bone tunnel 106. For example, in some embodiments, the pull-through strand 24
is cut to release
the pull-through strand 24 and the guide element 26 from the adjustable loop
6, although it will
be appreciated that the pull-through strand 24 and/or the guide element 26 can
be release from
the adjustable loop 6 using any suitable method. After inserting the
adjustable loop 6 through
the bone tunnel 106, the free ends 20a, 20b, which are positioned outside of
bone tunnel 106, are
pulled to shorten the adjustable loop 6. The second anchor 16 is coupled to
the second end 10 of
the adjustable loop 6 to couple the second end 10 to the second bone 104. The
adjustable loop 6
can be further shortened to position the first bone 102 and the second bone
104 in a selected
spacing. The adjustable loop 6 can be shortened prior to, simultaneously with,
or after coupling
the second anchor 16 to the second end 10 of the adjustable loop 6.
[0036] FIG. 4 illustrates a partial anchoring construct 30a including
flexible strand 4a
defining a plurality of adjustable loops 6a, 6b extending through strand
passages 60a, 60b, in
accordance with some embodiments. The partial anchoring construct 30a is
similar to the partial
anchoring construct 30 described above, and similar description is not
repeated herein. The
flexible strand 4a includes a first strand passage 60a and a second strand
passage 60b. The
strand passages 60a, 60b include a flexible material defining a channel or
passage 52a, 52b. The
flexible material can include a similar material to the flexible strand 4a
and/or a different
material. The strand passages 60a, 60b can be formed integrally with the
flexible strand 4a, can
be coupled to the flexible strand 4a, and/or can be freely moveable with
respect to the flexible
strand 4a.
Date Recue/Date Received 2021-08-09
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[0037] In some embodiments, a first end 20a of the flexible strand 4a is
passed through a
first strand passage 60a to define a first adjustable loop 6a and a second end
20b of the flexible
strand 4a is passed through a second strand passage 60b to define a second
adjustable loop 6b.
The first and second adjustable loops 6a, 6b can be interlocked (e.g., the
first adjustable loop 6a
is looped through the second adjustable loop 6b). In some embodiments, the
first strand passage
60a and the second strand passage 60b have a predetermined spacing
therebetween sized and
configured to receive the first anchor 14 therein, as discussed in greater
detail with respect to
FIGS. 7-10.
[0038] FIG. 5 illustrates a flexible strand 4b defining a first woven
passage 60c and a
second woven passage 60d, in accordance with some embodiments. The flexible
strand 4b is
similar to the flexible strand 4a described above, and similar description is
not repeated herein.
The first and second woven passages 60c, 60d include a first portion of the
flexible strand 4b that
is woven about a second portion of the flexible strand 4b to define each of
the strand passages
60c, 60d having a portion of the flexible strand 4b extending therethrough. In
some
embodiments, the woven passages 60c, 60d are self-tightening when a
predetermined force is
applied to the flexible strand 4b. For example, in some embodiments, the woven
passages 60c,
60d are configured to constrict as force is applied to the free ends 20a, 20b
of the flexible strand
4b. When the force exceeds a predetermined threshold, the woven passages 60c,
60d are
constricted such that the flexible strand 4b extending through the woven
passages 60c, 60d is
locked in place.
[0039] FIG. 16 illustrates a flat button anchor 90, in accordance with
some embodiments.
The flat button anchor 90 can be used as a first anchor 14 and/or a second
anchor 16 with respect
to the syndesmotic anchoring system 2. The flat button anchor 90 includes a
first side 92a and a
second side 92b coupled by a center post 94. Each of the first side 92a and
the second side 92b
include a first arm 96a and a second arm 96b extending at a predetermined arc
from the center
post 94. Each of the arms 96a, 96b define cutouts 99 sized and configured to
receive a portion of
an adjustable loop 6 thereabout. The flat button anchor 90 is configured to
couple a distal end of
an adjustable loop 6 to a second bone 104.
Date Recue/Date Received 2021-08-09
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[0040] In some embodiments, a flat button anchor 90 is coupled to the
second end 10 of
the adjustable loop 6 after being passed through the bone tunnel 106. In some
embodiments, the
flat button anchor 90 defines a plurality of holes 98 sized and configured to
receive an adjustable
loop 6 and/or flexible strand 4 therethrough. In other embodiments, the flat
button anchor 90
includes one or more cutouts 99 configured to receive a portion of the
flexible strand 4
therethrough. The cutouts 99 are sized and configured to receive the flexible
strand 4 but
prevent passage of the strand passages 60a, 60b therethrough. Although
specific embodiments
are illustrated, it will be appreciated that the flat button anchor 90 can
include any suitable
combination of openings for receiving the flexible strand 4 therethrough.
[0041] FIG. 17 illustrates a knot capsule anchor 80, in accordance with
some
embodiments. The knot capsule anchor 80 can be used as a first anchor 14
and/or a second
anchor 16 with respect to the syndesmotic anchoring system 2. The knot capsule
80 includes a
base 82 and an extension 84 extending therefrom. The extension 84 defines a
strand passage
sized and configured to receive a flexible strand 4 therethrough. In some
embodiments, the
extension 84 is sized and configured to be inserted at least partially within
the bone tunnel 106.
Knot capsules are described in greater detail in International Patent
Application
PCT/US16/66902.
[0042] FIG. 6 is a flowchart illustrating a method 200 of syndesmotic
repair using the
syndesmotic system 2 described above, in accordance with some embodiments. At
step 202, a
bone tunnel 106 is formed through a first bone 102 and a second bone 104. The
bone tunnel 106
can be formed by any suitable instrument, such as, for example, a drill, a k-
wire, a reamer, and/or
any other suitable instrument. Although step 202 is illustrates as an
independent step in method
200, it will be appreciated that the formation of the bone tunnel 106 can
occur simultaneously
and/or integrally with one or more additional steps discussed below.
[0043] At step 204, a guide element 26 is inserted through the bone
tunnel 106 from a
first side 106a to a second side 106b. The guide element 26 is coupled to a
second end 10 of an
adjustable loop 6 of a partial anchoring construct 30. The guide element 26
can be coupled to
the adjustable loop 6 by a pull-through strand 24 and/or can be directly
coupled to the adjustable
Date Recue/Date Received 2021-08-09
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loop 6. The guide element 26 can include any suitable resilient element
configured to be inserted
through the first bone 102 and the second bone 104, such as a needle, k-wire,
etc. In some
embodiments, the guide element 26 is configured to form the bone tunnel 106
simultaneously
with insertion through the first bone 102 and the second bone 104 such that
step 202 and step
204 are performed as a single step.
[0044] At step 206, the adjustable loop 6 is passed through the bone
tunnel 106 by the
guide element 26. At step 208, a first anchor 14 coupled to a first end 8 of
the adjustable loop 6
is abutted against a first side of the first bone 102. The first anchor 14 can
include any suitable
anchor, such as a button, a knot capsule, a fastener, and/or any other
suitable anchor. The first
anchor 14 can be coupled to the adjustable loop 6 prior to and/or after
insertion of the adjustable
loop 6 through the bone tunnel 106. In some embodiments, the first anchor 14
is sized and
configured to be positioned between a first strand passage 60a and a second
strand passage 60b
formed in the flexible strand 4. The first anchor 14 can be abutted against
the first bone 102 by
passing the adjustable loop 6 through the bone tunnel 106 and/or by shortening
the adjustable
loop 6.
[0045] At step 210, a second anchor 16 is coupled to the second end 10 of
the adjustable
loop 6. The second anchor 16 can include any suitable anchor, such as a
button, a knot capsule,
a fastener, and/or any other suitable anchor. At step 212, the adjustable loop
6 is shortened (e.g.,
tightened) to abut the second anchor 16 against an outer sursurface of the
second bone 104. The
adjustable loop 6 is further shortened to position the first bone 102 and the
second bone 104 in a
predetermined spacing. The adjustable loop 6 can be shortened by applying a
force to a first free
end 20a and/or a second free end 20b extending from the bone tunnel 106.
[0046] At step 212, the adjustable loop 6 is locked or fixed at a
selected spacing. For
example, in some embodiments, a knot is formed in the first free end 20a
and/or the second free
end 20b to maintain the adjustable loop 6 in a fixed position. In other
embodiments, the first
anchor 14 and/or the second anchor 16 can include a self-locking anchor, such
as a knot capsule
containing a self-locking knot configured to apply a locking force to the
adjustable loop 6 when a
predetermined force (corresponding to a predetermined spacing of first and
second bones 102,
Date Recue/Date Received 2021-08-09
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104) is applied to the flexible strand 4. Although specific embodiments are
discussed herein, it
will be appreciated that the adjustable loop 6 can be fixed at a selected
length using any suitable
method. At step 214, after passing the second end 10 of the adjustable loop 6
through the bone
tunnel 106, the guide element 26 (and the pull-through strand 24, if present)
is removed from the
second end 10 of the adjustable loop 6. The pull-through strand 24 and/or the
guide element 26
can be removed using any suitable method, such as, for example, cutting the
pull-through strand
24, cutting a portion of the flexible strand 4, and/or any other suitable
method. Although
embodiments are discussed herein having a disclosed order of steps, it will be
appreciated that
the one or more of the steps of method 200 may be completed one or more
additional and/or
alternative orders (for example, as illustrated in FIG. 12) and are within the
scope of this
disclosure.
[0047] FIGS. 7-9 illustrate a syndesmotic anchoring system 2a including a
bone plate 40,
in accordance with some embodiments. The syndesmotic anchoring system 2a is
similar to the
syndesmotic anchoring system 2 discussed above, and similar description is not
repeated herein.
The syndesmotic anchoring system 2a includes a bone plate 40. The bone plate
40 is sized and
configured to abut one of the first bone 102 or the second bone 104. The bone
plate 40 includes
a body 42 extending between a bone facing surface 44 and an opposite surface
46 and defined by
a perimeter 48. One or more fastener holes 50 can extend between the bone
facing surface 44
and the opposite surface 46. The one or more fastener holes 50 are sized and
configured to
receive fasteners 52 therethrough. The fasteners 52 can include any suitable
fastener, such as a
screw, pin, k-wire, etc., configured to couple the bone plate 40 to a selected
one of the first bone
102 or the second bone 104. Further, fasteners 52 can be locking, non-locking,
or poly-axial
screws.
[0048] The bone plate 40 defines at least one construct hole 54. Each
construct hole 54
is sized and configured to receive a portion of the partial anchoring
construct 30b therethrough.
The construct holes 54 are configured to be aligned with a bone tunnel 106
formed in the first
and second bones 102, 104 when the bone plate 40 is coupled to one of the
first bone 102 or the
second bone 104. In some embodiments, the construct hole 54 includes a
countersink sized and
configured to receive at least a portion of the first fastener 14 and/or a
second fastener 16 therein.
Date Recue/Date Received 2021-08-09
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For example, in some embodiments, the construct hole 54 includes a countersink
sized and
configured to receive a first anchor 14 including a flat button therein such
that the flat button is
flush with the opposite surface 46 of the bone plate 40 when the partial
anchoring construct 30 is
tightened (see FIG. 8.)
[0049] In some embodiments, the flexible strand 4c includes a first
strand passage 60a
and a second strand passage 60b. A first end 20a of the flexible strand 4c is
passed through the
first strand passage 60a to define a first adjustable loop 6a and a second end
20b of the flexible
strand 4c is passed through a second strand passage 60b to define a second
adjustable loop 6b.
The first and second adjustable loops 6a, 6b can be interlocked (e.g., the
first adjustable loop 6a
is looped through the second adjustable loop 6b.)
[0050] In some embodiments, the first strand passage 60a and the second
strand passage
60b are spaced apart such that the first anchor 14 may be positioned between
the first and second
strand passages 60a, 60b. The first anchor is adjacent to each of the first
and second strand
passages such thatno portion of the strand passages 60a, 60b extend into or
through the first
anchor 14. For example, in some embodiments, the spacing between the strand
passages 60a,
60b is selected such that the first strand passage 60a and the second strand
passage 60b are
positioned immediately adjacent to (and on opposite sides of) the first anchor
14 when the first
anchor 14 is positioned between the strand passages 60a, 60b and coupled to
the flexible strand
4c. In other embodiments, the strand passages 60a, 60b are positioned adjacent
to and spaced
apart from the first anchor 14 when the first anchor 14 is coupled to the
flexible strand 4c.
[0051] As shown in FIG. 7, in some embodiments, the free ends 20a, 20b of
the
adjustable loop 6 and the pull-through suture 24 are coupled to a guide
element 26, such as a k-
wire shuttle. The free ends 20a, 20b and the pull-through suture 24 are passed
from a first side
106a of the bone tunnel 106 to a second side 106b. The guide element 26 is
passed through one
of the construct holes 54 formed in the bone plate 40 prior to being passed
through the first bone
102 and the second bone 104. The guide element 26 is passed through the bone
tunnel 106 to
draw the free ends 20a, 20b, pull-through suture 24, and adjustable loops 6a,
6b into the bone
tunnel 106. The guide element 26 is advanced out of the bone tunnel 106 to
extend free ends
Date Recue/Date Received 2021-08-09
14
20a, 20b and pull-through suture 24 from a second end 106b of the bone tunnel
106. The guide
element 26 and/or the pull-through suture 24 can be further advanced away from
the bone tunnel
106 such that a second end 10 of each of adjustable loops 6a, 6b extend from
the second end
106b of the bone tunnel 106. In some embodiments, a second anchor 16 can be
coupled to the
second end 10 of each of the adjustable loops 6a, 6b. The guide element 26 can
be disconnected
from the free ends 20a, 20b and the pull-through suture 24, for example by
cutting the free ends
20a, 20b and the pull-through suture 24, prior to, during, and/or after
coupling the second anchor
16 to the second end 10 of the adjustable loops 6a, 6b.
[0052] FIG. 8 illustrates a second anchor 16 coupled to a second end 10
of each of the
adjustable loops 6a, 6b after the adjustable loops 6a, 6b are passed through
the bone tunnel 106.
In the illustrated embodiment, the pull-through suture 24 has been previously
cut to disconnect
the pull-through suture 25 from the adjustable loops 6a, 6b and the adjustable
loops 6a, 6b have
been advanced into the bone tunnel 106 a sufficient distance such that the
first anchor 14 is
positioned flush against the bone plate 40. As shown in FIG. 9, the guide
element 26 and the
pull-through strand 24 are disconnected from the adjustable loops 6a, 6b and
the free ends 20a,
20b of the adjustable loops 6a, 6b can be used to tighten (e.g., shorten) the
adjustable loops 6a,
6b to position the first anchor 14 and the second anchor 16 against the bone
plate 40 and the
second bone 104, respectively. In some embodiments, the free ends 20a, 20b can
be cut from (or
otherwise released from) the guide element 26 prior to tightening of the
adjustable loops 6a, 6b.
In other embodiments, the free ends 20a, 20b can be tightened by pulling the
guide element 26 in
a direction away from the first bone 102 and/or the second bone 104. The
adjustable loops 6a,
6b maintain the first bone 102 and the second bone 104 at a predetermined
spacing and/or within
a predetermined range of motion. FIGS. 10-11 illustrate the syndesmotic repair
system 2a
inserted from a second side 106b of a bone tunnel 106 to a first side 106a.
[0053] For example, as shown in FIG. 10, the guide element 26 may be
passed from the
second side 106b of the bone tunnel 106 to the first side 106a such that the
guide element 26
extends out of the bone tunnel 106 and through a construct hole 54 formed in
bone plate 40. The
free ends 20a, 20b and the pull through suture 24 are further passed from the
second end 106b to
the first end 106a of the bone tunnel. The free ends 20a, 20b extend from the
bone tunnel 106
Date Recue/Date Received 2021-08-09
15
and through the construct hole 54. The guide element 26 and/or the pull-
through suture 24 can
be advanced further from the bone tunnel 106 such that a second end 10 of each
of the adjustable
loops 6a, 6b extends from a first end 106a of the bone tunnel 106.
[0054] As shown in FIG. 11, the adjustable loops 6a, 6b can be advanced
and/or adjusted
such that the first anchor 14 abuts the second bone 104 adjacent to a second
end 106b of the bone
tunnel 106. A second anchor 16 can be coupled to the second end 10 of the
adjustable loops 6a,
6b. The guide element 26 and the pull-through strand 24 are disconnected from
the adjustable
loops 6a, 6b and the free ends 20a, 20b of the adjustable loops 6a, 6b can be
used to tighten (e.g.,
shorten) the adjustable loops 6a, 6b to position the first anchor 14 and the
second anchor 16
against the the second bone 104 and the bone plate 40, respectively. The guide
element 26
and/or the pull-through strand 24 can be removed prior to, during, and/or
after coupling of the
second anchor 16 to the adjustable loops 6a, 6b and/or after tightening of the
adjustable loops 6a,
6b. As the adjustable loops 6a, 6b are tightened, the second anchor 16 is
positioned against the
bone plate 40, for example, within a countersink defined by construct hole 54.
[0055] FIG. 14 illustrates a partial anchoring construct 30d including a
first independent
adjustable loop 6a and a second independent adjustable loop 6b, in accordance
with some
embodiments. The partial anchoring construct 30d is similar to the partial
anchoring construct
30 described above, and similar description is not repeated herein. The
partial anchoring
construct 30d includes a flexible strand 4 defining a first independent
adjustable loop 6a and a
second independent adjustable loop. The first and second independent
adjustable loops 6a, 6b
are separately formed and do not overlap. In some embodiments, each of the
first and second
independent adjustable loops 6a, 6b are coupled to a pull-through strand 24.
[0056] In some embodiments, each of the independent adjustable loops 6a,
6b are formed
by passing a free end 20a, 20b of the flexible strand 4 respectively through a
first woven passage
60a and a second woven passage 60b. In the illustrated embodiment, the woven
passages 60a,
60b are positioned on the same side of a first anchor 14 as the independently
adjustable loops 6a,
6b and are configured to be inserted into a bone tunnel 106. In other
embodiments, the woven
passages 60a, 60b can be positioned opposite independent the adjustable loops
6a, 6b. The first
Date Recue/Date Received 2021-08-09
16
free end 20a is configured to adjust the first independent adjustable loop 6a
and the second free
end 20b is configured to adjust the second independent adjustable loop 6b.
Each of the free ends
20a, 20b extend on an opposite side of the first anchor 14 from the
independent adjustable loops
6a, 6b.
[0057] FIG. 15 illustrates the partial anchoring construct 30d of FIG. 14
inserted through
a bone tunnel 106 defined in a first bone 102 and a second bone 104 and having
a second anchor
16 coupled to a second end 10 of each of the first independent adjustable loop
6a and the second
independent adjustable loop 6b, in accordance with some embodiments. As shown
in FIG. 15,
both independent adjustable loops 6a, 6b are passed through the bone tunnel
106 and coupled to
the second anchor 16. The second anchor 16 can be coupled to the independent
adjustable loops
6a, 6b using an anchor holder 70. The anchor holder 70 is configured to allow
a surgeon to
manipulate the second button 16 to couple the second button 16 to the second
end 10 of each of
the independent adjustable loops 6a, 6b.
[0058] As further shown in FIG. 15, the free ends 20a, 20b of each of the
independent
adjustable loops 6a, 6b extend from the first anchor 14 and are not inserted
through or into the
bone tunnel 106. After coupling the second button 16 to each of the
independent adjustable
loops 6a, 6b, the free ends 20a, 20b can be pulled away from the first and
second bones 102, 104
to tighten the independent adjustable loops 6a, 6b and position the first
anchor 14 and the second
anchor 14 against the first and second bone 102, 104, respectively. As shown
in FIG. 15, in
some embodiments, multiple partial anchoring constructs 30d can be inserted
through multiple
bone tunnels 106 and coupled to multiple second anchors 16 to position the
first bone 102 and
the second bone 104 at a predetermined spacing.
[0059] FIG. 12 is a flowchart illustrating a method 200a of syndesmotic
repair using the
syndesmotic system 2a described above in conjunction with FIGS. 7-10, in
accordance with
some embodiments. The method 200a is similar to the method 200 described above
in
conjunction with FIG. 6, and similar description is not repeated herein. At
step 220, a bone plate
40 is coupled to the first bone 102. In some embodiments, the bone plate 40 is
coupled to the
first bone 102 by a fastener 52 inserted through at least one fastener hole 50
formed in the bone
Date Recue/Date Received 2021-08-09
17
plate 40. The fastener 52 can include any suitable fastener, such as a screw,
pin, k-wire, etc.
configured to couple the bone plate 40 to the first bone 102. The bone plate
40 is coupled to the
first bone 102 such that at least one construct hole 54 is aligned with the
bone tunnel 106 formed
through the first and second bones 102, 104.
[0060] At step 204a, the guide element 26 is passed through a construct
hole 54 formed
in the bone plate 40 and through the bone tunnel 106. The construct hole 54 is
sized and
configured to allow passage of the guide element 26 and the adjustable loop 6
but prevent
passage of the first anchor 14 therethrough. In some embodiments, the
construct hole 54
includes a countersink sized and configured to receive the first anchor 14
therein. The method
200a proceeds similar to the method 200 after insertion of the partial
anchoring construct 30
through the construct hole 54.
[0061] FIG. 13 illustrates a partial anchoring construct 30c including a
first adjustable
loop 6a and a second adjustable loop 6b, in accordance with some embodiments.
The partial
anchoring construct 30c is similar to the partial anchoring construct 30
described above, and
similar description is not repeated herein. The first adjustable loop 6a and
the second adjustable
loop 6b each extend from a first end 8 coupled to a first anchor 14. The
adjustable loops 6a, 6b
can be formed from a single flexible strand 4 and/or can be formed from
multiple flexible strands
coupled to the first anchor 14 of the partial anchoring construct 30b.
[0062] As illustrated in FIG. 13, in some embodiments, the first
adjustable loop 6a is
configured to extend through a first bone tunnel and the second adjustable
loop 6b is configured
to extend through a second bone tunnel. A second end 10a of the first
adjustable loop 6a is
coupled to a first guide element 26a and the second end 10b of the second
adjustable loop 6b is
coupled to a second guide element 26b. The first guide element 26a is
configured to pass the
first adjustable loop 6a through a first bone tunnel and the second guide
element 26b is
configured to pass the second adjustable loop 6b through the second bone
tunnel. In some
embodiments, the first guide element 26a is inserted through the first bone
tunnel prior to the
second guide element 26b being inserted through the second bone tunnel,
although it will be
appreciated that the second guide element 26b can be inserted before,
simultaneously with, or
Date Recue/Date Received 2021-08-09
18
after insertion of the first guide element 26a. After inserting the first and
second guide elements
26a, 26b through respective bone tunnels 106a, 106b, a second anchor 16a is
coupled to the
second end 10a of the first adjustable loop 6a and a second anchor 16b is
coupled to the second
end 10b of the second adjustable loop 6b. The first and second adjustable
loops 6a, 6b can be
shortened simultaneously and/or independently to position the first bone 104
and the second
bone 106 in a predetermined spacing.
[0063]
Although the invention has been described in terms of exemplary embodiments,
it
is not limited thereto. Rather, the appended claims should be construed
broadly, to include other
variants and embodiments of the invention, which may be made by those skilled
in the art
without departing from the scope and range of equivalents of the invention.
Date Recue/Date Received 2021-08-09
