Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
WO 2022/232151
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BONE REPAIR DEVICES AND METHODS
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Patent Application No.
63/180561 (filed on April, 27, 2021 and entitled "Bone Repair Devices and
Methods"), U.S.
Provisional Patent Application No. 63/227060 (filed on July 29, 2021 and
entitled "Sternum
Fixation Devices and Methods"), and U.S. Patent Application No. 17/353011
(filed on June 21,
2021 and entitled "Sternum Fixation Devices and Methods"). The entire contents
of each of the
aforementioned applications are hereby incorporated herein by reference for
all purposes.
FIELD OF THE INVENTION
[0002] Embodiments of the present invention relate generally to
methods and apparatuses for
stabilizing a bone and for removal of excess fluid from a surgical site.
BACKGROUND OF THE INVENTION
[0003] In stemotomy surgeries, the patient's sternum is severed in
half to create access to the
inter-thoracic cavity to perform operative surgical procedures. Following such
procedures, the two
separated halves of the sternum must be repositioned adjacent to each other
and affixed so that the
two halves may be permitted to heal. Attempts have been made to constrain the
separated halves
together using wire threaded around the sternum and manually tensioned and
twisted into place.
However, wire can cause irritation to the sternum and other surrounding areas
of the body, causing
the patient additional pain and discomfort. Additionally, there are inherent
inconsistencies from
surgeon to surgeon as to the positioning of the wire, the tightness of the
tensioning, the manner of
twisting, etc.
[0004] Furthermore, after surgical procedures and/or a stemotomy,
excess fluid (e.g. blood)
may collect around a surgical site. If excess fluid is not removed, this
excess fluid may become
infectious, posing serious risk to the health of the patient and retarding or
preventing recovery.
Through ingenuity and effort, the inventors have developed various
improvements to reclosure of
the sternum following sternotomies and draining of related fluid.
BRIEF SUMMARY OF THE INVENTION
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[0005] Various embodiments provided herein disclose methods and
apparatuses for stabilizing
a bone and/or for removal of excess fluid from a surgical site. A plate
assembly is contemplated
having a fixation plate that may be positioned against a bone, such as the
sternum, to assist in the
stabilization of the bone. Bands may be attached to the fixation plate and
wrapped around the
fixation plate and the bone so that the bands form a loop. The loops formed by
the bands may be
tensioned and eventually cut by a tensioning gun. The fixation plate may have
windows and other
openings therein to generally create an open architecture within the fixation
plate, and this open
architecture may be beneficial to permit the free passage of blood and
biological materials to effect
healing at a bone site.
[0006] A surgical drain assembly may be provided in some
embodiments as well. The surgical
drain assembly may comprise a drain body that may be provided between the
fixation plate and a
bone (e.g. the sternum). The drain body may be snap fitted or otherwise
attached to the fixation
plate. Furthermore, the drain body may have extension tubes attached to the
drain body, and the
extension tubes may be wrapped behind the sternum or behind another bone to
collect any excess
fluid, such as blood, at that location. A drainage tube and/or an inlet tube
may also be provided.
The drainage tube may permit fluid collected from an internal cavity of the
drain body to be
removed from the patient's body, and the inlet tube may permit fluids (e.g.
medicines, etc.) to be
introduced to a surgical site via the surgical drain assembly. The drain body
may be positioned
above the sternum and the fixation plate to permit easy installation and
removal of the drain body.
[0007] The tensioning gun may permit a user to set a tension limit,
with this tension limit being
the maximum tension that may be applied to a band using the tensioning gun.
Once the tension
limit has been reached, the tensioning gun may cease applying tension and a
cutting blade may be
activated to cut the band. Alternatively, the tensioning gun may continue to
apply tension to the
band at or around the tension limit, and the tensioning gun may cause the
cutting blade to be
actuated to cut the band.
[0008] While bands may be manually installed, tensioned, and then
cut, it may be
disadvantageous to perform these tasks manually for several reasons. First,
manual performance
of these tasks can lead to human error. The bands may not be tightened to an
appropriate tension
and this may cause the patient to heal improperly and/or to experience pain
(i.e. too loose may
allow too much movement of the sternum; too tight may cause pain for the
patient or too much
tension on the sternum). Second, manual performance of the tasks will be less
user-friendly. Where
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the fixation plate is being installed at a severed sternum, one or more
installers would need to
maintain the two severed sternum halves in an appropriate position, they would
need to maintain
the fixation plate at the appropriate position, and they would need to install
bands to retain the
fixation plate in the appropriate position. This may be difficult to do at the
same time, increasing
frustration for the installers and leading to an increased risk of error
during installation. Third,
manual performance of the tasks may very time consuming for installer(s).
[0009] Tensioning guns are contemplated that may be used to apply
tension to bands until a
desired tension level is reached. Once the desired tension level is reached,
the tensioning gun may
cut the band. The tensioning gun may reduce human error by maintaining a
consistent amount of
tension in each band. Manual tensioning places undue reliance on user judgment
based on prior
experience, visualization or tactile feel, and approximations or guesswork
from the installer may
lead to errors. The tensioning gun may be easier for installers to operate,
thereby eliminating any
approximations or guesswork from the installer as to whether the tension level
is appropriate. By
cutting the bands automatically after the desired tension is obtained, this
may alleviate the need
for the installer to perform this task separately. The tensioning gun may also
tighten the bands
more quickly than manual tightening of bands.
[0010] In an example embodiment, a method of stabilizing a bone is
provided. The method
includes providing a fixation plate; providing a band having a head and a
tail, the head having an
internal cavity configured to receive a portion of the tail; providing a
tensioning tool; positioning
the fixation plate adjacent to the bone; wrapping an end of the tail around
the fixation plate and
the bone and inserting the end of the tail into the head to form a loop,
wherein the fixation plate
and the bone are positioned within the loop; inserting the end of the tail
into the tensioning tool;
applying tension to the band to tighten the band about the fixation plate and
bone using the
tensioning tool; and cutting an excess portion of the band with the tensioning
tool once a tension
limit has been reached.
[0011] In some embodiments, the method may also include providing a
second band having a
head and a tail; wrapping an end of the tail of the second band around the
fixation plate and the
bone and inserting the end of the tail of the second band into the head of the
second band to form
a second band loop, with the fixation plate and the bone being positioned
within the second band
loop; applying tension to the second band to tighten the second band about the
fixation plate and
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bone using the tensioning tool; and cutting an excess portion of the second
band with the tensioning
tool once a tension limit has been reached.
[0012] In some embodiments, the bone being stabilized may be a
sternum of a human that has
been cut via sternotomy. Positioning the fixation plate at the bone may
include positioning the
fixation plate proximate to a cut formed between two severed halves of the
sternum. Furthermore,
the method may also include attaching the head of the band to the fixation
plate in some
embodiments. Additionally, in some embodiments, the method may include setting
a tension limit
for the tensioning tool.
[0013] In another example embodiment, a plate assembly for
stabilizing a bone is provided.
The plate assembly includes a fixation plate having two or more rails that
form at least one window.
The plate assembly also includes at least one band, and the band(s) have a
tail as well as a head
that defines an internal cavity being configured to receive a portion of the
tail. The plate assembly
also includes a surgical drain having a plurality of extension tubes and a
drain body that is
configured to attach to the fixation plate. The drain body defines an internal
cavity, and the
plurality of extension tubes are configured to collect fluid and transfer the
fluid to the internal
cavity. The fixation plate is configured to be positioned adjacent to a bone,
and the head is
configured to be attached to the fixation plate between the rails within a
window. The band(s) are
configured to be wrapped around the fixation plate and the bone, and the
internal cavity of the
head is configured to receive an end of the tail to form a loop. The band(s)
are configured to receive
a tension force to tighten the loop formed by the band(s).
[0014] In some embodiments, a tensioning tool may be used to apply
a tension force to the
band(s). The tensioning tool may have a tension limit that is the maximum
tension that can be
applied to a given band. The tensioning tool may be configured to apply
tension to the band(s)
until the tension limit has been reached. The tensioning tool may be
configured to actuate a cutting
blade to cut the band(s) upon at least one of the tension limit being reached
or upon a user
command. Additionally, in some embodiments, the drain body may have at least
one protrusion.
The protrusion( s) may be configured to be press fit to the window(s) of the
fixation plate.
[0015] In some embodiments, the surgical drain may include a
drainage tube connected to the
drain body, and the drainage tube may be configured to permit the removal of
fluid that has
collected in the internal cavity of the drain body. Additionally, in some
related embodiments, the
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drainage tube may have a free end, and the free end may be configured to
attach to a negative
pressure device to create a negative pressure in the surgical drain.
[0016] In some embodiments, the fixation plate may be configured to
be installed in front of
the bone and the surgical drain may be configured to be installed in front of
the fixation plate. The
plurality of extension tubes may be configured to extend behind the bone to
collect excess fluid
located behind the bone. In some embodiments, the bone may be a sternum, and
the surgical drain
may be configured to be installed in front of the sternum. The plurality of
extension tubes may be
configured to extend behind the sternum through intercostal spaces between
ribs to collect excess
fluid located behind the sternum. Additionally, the surgical drain may also
include an inlet tube
connected to the drain body, and the inlet tube may be configured to receive
fluids to be introduced
at a surgical site via the surgical drain.
[0017] In another example embodiment, a tensioning tool for
applying tension to a band is
provided. The tensioning tool includes a handle. The tensioning tool also
includes a barrel having
a channel at an end of the barrel, and the channel is configured to receive a
portion of the band.
The tensioning tool also includes a cutting blade that is configured to remove
an excess portion of
the band. The tensioning tool has a tension limit that is the maximum tension
that can be applied
to a given band, and the tensioning tool is configured to apply tension to the
band until the tension
limit has been reached. The tensioning tool is configured to actuate the
cutting blade to cut the
band upon at least one of the tension limit being reached or upon a user
command.
[0018] In some embodiments, the tensioning tool may include a
clutch mechanism such as a
rotatable knob that is configured to set the tension limit. In related
embodiments, the tensioning
tool may be configured to disengage from the band upon the tension limit being
reached to prevent
over-tensioning. Additionally, in some embodiments, the tensioning tool may be
configured to
maintain the tension on the band at a consistent level upon the tension limit
being reached, and the
tensioning tool may be configured to cut the band upon the tension limit being
reached.
[0019] In some embodiments, the cutting blade may be located
proximate to the tip of the
barrel. Additionally, in some related embodiments, an actuator lever may be
provided in the
tensioning tool that is configured to cause at least one of actuation of the
cutting blade or
application of tension to the band. In further related embodiments, the
actuator lever may be
configured to cause both the actuation of the cutting blade and the
application of tension to the
band. Additionally, in some related embodiments, a switch may be provided in
the tensioning tool
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that is configured to switch between a cutting mode and a tensioning mode.
Compression of the
actuator lever may cause actuation of the cutting blade in the cutting mode,
and compression of
the actuator lever may cause tension to be applied to the band in the
tensioning mode.
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] Having thus described the invention in general terms,
reference will now be made to
the accompanying drawings, which are not necessarily drawn to scale, and
wherein:
[0021] FIG. lA illustrates a top view of an example band, in
accordance with some
embodiments discussed herein;
[0022] FIG. 1B illustrates an enhanced top view of a head of the
band of FIG. 1A, in
accordance with some embodiments discussed herein;
[0023] FIG. 1C illustrates an enhanced side view of the head of the
band of FIG. 1A, in
accordance with some embodiments discussed herein;
[0024] FIG. 11) illustrates an enhanced perspective view of the
head of the band of FIG. IA,
in accordance with some embodiments discussed herein;
[0025] FIG. IE illustrates an enhanced cross-sectional view of the
head of the band of FIG.
11) about the line A'-A', in accordance with some embodiments discussed
herein;
[0026] FIG. 2A illustrates an enhanced top view of another example
band, in accordance with
some embodiments discussed herein;
[0027] FIG. 2B illustrates an enhanced side view of the head of the
band of FIG. 2A, in
accordance with some embodiments discussed herein;
[0028] FIG. 2C illustrates an enhanced perspective view of the head
of the band of FIG. 2A,
in accordance with some embodiments discussed herein;
[0029] FIG. 2D illustrates an enhanced cross-sectional view of the
head of the band of FIG.
2C about the line B'-B', in accordance with some embodiments discussed herein;
[0030] FIG. 3 illustrates an enhanced cross-sectional view of the
head of another example
band, in accordance with some embodiments discussed herein;
[0031] FIG. 4A illustrates an enhanced top view of another example
band, in accordance with
some embodiments discussed herein;
[0032] FIG. 4B illustrates an enhanced side view of the band of
FIG. 4A, in accordance with
some embodiments discussed herein;
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[0033] FIG. 4C illustrates an enhanced perspective view of the band
of FIG. 4A, in accordance
with some embodiments discussed herein;
[0034] FIG. 4D illustrates an enhanced cross-sectional view of the
head of the band of FIG.
4B about the line C-C'. in accordance with some embodiments discussed herein;
[0035] FIG. 5A illustrates an enhanced side view of another example
band, in accordance with
some embodiments discussed herein;
[0036] FIG. 5B illustrates an enhanced perspective view of the band
of FIG. 5A, in accordance
with some embodiments discussed herein;
[0037] FIG. 6A illustrates a front view of an example fixation
plate, in accordance with some
embodiments discussed herein;
[0038] FIG. 6B illustrates a cross-sectional view of the fixation
plate of FIG. 6A about the line
D'-D', in accordance with some embodiments discussed herein;
[0039] FIG. 6C illustrates a side view of the fixation plate of
FIG. 6A, in accordance with
some embodiments discussed herein;
[0040] FIG. 6D illustrates a perspective view of the fixation plate
of FIG. 6A, in accordance
with some embodiments discussed herein;
[0041] FIG. 6E illustrates a top view of the fixation plate of FIG.
6A, in accordance with some
embodiments discussed herein;
[0042] FIG. 7A illustrates a front view of another example fixation
plate, in accordance with
some embodiments discussed herein;
[0043] FIG. 7B illustrates a cross-sectional view of the fixation
plate of FIG. 7A about the line
E'-E', in accordance with some embodiments discussed herein;
[0044] FIG. 7C illustrates a perspective view of the fixation plate
of FIG. 7A, in accordance
with some embodiments discussed herein;
[0045] FIG. 7D illustrates a side view of the fixation plate of
FIG. 7A, in accordance with
some embodiments discussed herein;
[0046] FIG. 7E illustrates a side view of an example fixation plate
having spikes on its bottom
surface, in accordance with some embodiments discussed herein;
[0047] FIG. 8A illustrates a front view of another example fixation
plate, in accordance with
some embodiments discussed herein;
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[0048] FIG. 8B illustrates a side view of the fixation plate of
FIG. 8A, in accordance with
some embodiments discussed herein;
[0049] FIG. 8C illustrates a cross-sectional view of the fixation
plate of FIG. 8A about the line
F -F', in accordance with some embodiments discussed herein;
[0050] FIG. 8D illustrates a perspective view of the fixation plate
of FIG. 8A, in accordance
with some embodiments discussed herein;
[0051] FIG. 9A illustrates a front view of another example fixation
plate, in accordance with
some embodiments discussed herein;
[0052] FIG. 9B illustrates a cross-sectional view of the fixation
plate of FIG. 9A about the line
G'-G', in accordance with some embodiments discussed herein;
[0053] FIG. 9C illustrates a side view of the fixation plate of
FIG. 9A, in accordance with
some embodiments discussed herein;
[0054] FIG. 9D illustrates a perspective view of the fixation plate
of FIG. 9A, in accordance
with some embodiments discussed herein;
[0055] FIG. 10A illustrates a top view of an example fixation plate
with an example band
assembled to the fixation plate, in accordance with some embodiments discussed
herein;
[0056] FIGS. 10B-10D illustrate cross-sectional views of the
fixation plate and band of FIG.
10A about the line F1.-H', in accordance with some embodiments discussed
herein;
[0057] FIG. 10E illustrates a top view of the fixation plate and
band of FIG. 10A where the
attached band has been rotated, in accordance with some embodiments discussed
herein;
[0058] FIG. 11A illustrates a perspective view of an example
tensioning gun being used to
generate tension on an example band, in accordance with some embodiments
discussed herein;
[0059] FIG. 11B illustrates an enhanced view of the tensioning gun
and band of FIG. 11A, in
accordance with some embodiments discussed herein;
[0060] FIG. 12A illustrates a top view of an example tensioning
gun, in accordance with some
embodiments discussed herein;
[0061] FIG. 12B illustrates a side view of the tensioning gun of
FIG. 12A, in accordance with
some embodiments discussed herein;
[0062] FIG. 13A illustrates a perspective view of an example
tensioning gun being used to
generate tension on an example band where a sidewall of the tensioning gun is
made transparent,
in accordance with some embodiments discussed herein;
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[0063] FIG. 13B illustrates an enhanced view of the tensioning gun
of FIG. 13A, in accordance
with some embodiments discussed herein;
[0064] FIG. 14 illustrates an enhanced cross sectional view of an
example tensioning gun
being used to generate tension on a band, in accordance with some embodiments
discussed herein;
[0065] FIG. 15 illustrates an example cutting blade of a trim
system for a tensioning gun being
used to cut an excess portion of a tail for a band, in accordance with some
embodiments discussed
herein;
[0066] FIG. 16A illustrates a front view of an example fixation
plate assembled at a sternum,
in accordance with some embodiments discussed herein;
[0067] FIG. 16B illustrates a perspective view of the fixation
plate of FIG. 16A assembled at
the sternum, in accordance with some embodiments discussed herein;
[0068] FIG. 17 illustrates a perspective view of an example
tensioning gun being used to assist
in securing an example fixation plate to a sternum of a person, in accordance
with some
embodiments discussed herein;
[0069] FIG. 18A illustrates a perspective view of an example
fixation plate being positioned
against a cut sternum, in accordance with some embodiments discussed herein;
[0070] FIG. 18B illustrates a perspective view of the fixation
plate of FIG. 18A with a band
being assembled to the fixation plate, in accordance with some embodiments
discussed herein;
[0071] FIG. 18C illustrates a perspective view of the fixation
plate of FIG. 18A with a
tensioning gun being used to tension and cut bands, in accordance with some
embodiments
discussed herein;
[0072] FIG. 19A illustrates a bottom view of an example drainage
assembly, in accordance
with some embodiments discussed herein;
[0073] FIG. 19B illustrates a side view of the drainage assembly of
FIG. 19A, in accordance
with some embodiments discussed herein;
[0074] FIG. 19C illustrates a schematic view of the drainage
assembly of FIG. 19A having an
internal cavity, in accordance with some embodiments discussed herein;
[0075] FIG. 19D illustrates an enhanced view of an example drain
body of a drainage assembly
having suture holes, in accordance with some embodiments discussed herein;
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[0076] FIG. 19E illustrates an enhanced view of the drain body of
FIG. 19A having a plurality
of openings in the surface of the drain body, in accordance with some
embodiments discussed
herein;
[0077] FIG. 19F illustrates a bottom schematic view of another
example drainage assembly,
in accordance with some embodiments discussed herein;
[0078] FIG. 19G illustrates a top schematic view of the drainage
assembly of FIG. 19F, in
accordance with some embodiments discussed herein;
[0079] FIG. 20 illustrates an example method for installing a
fixation plate and a drainage
assembly to a severed sternum, in accordance with some embodiments discussed
herein;
[0080] FIG. 21 illustrates an alternative tensioning gun having a
switch to alternate between a
cutting mode and a tensioning mode, in accordance with some embodiments
discussed herein; and
[0081] FIG. 22 illustrates another alternative tensioning gun, in
accordance with some
embodiments discussed herein.
DETAILED DESCRIPTION
[0082] Example embodiments of the present invention now will be
described more fully
hereinafter with reference to the accompanying drawings, in which some, but
not all embodiments
of the invention are shown. Indeed, the invention may be embodied in many
different forms and
should not be construed as limited to the example embodiments set forth
herein; rather, these
embodiments are provided so that this disclosure will satisfy applicable legal
requirements. Like
reference numerals generally refer to like elements throughout. For example,
reference numerals
104, 204, 304, etc. may each refer to the head of a band. Additionally, any
connections or
attachments may be direct or indirect connections or attachments unless
specifically noted
otherwise.
[0083] Various bands may be provided that may be used to form loops
that may be compressed
around a sternum and tensioning plate. FIG. lA illustrates a top view of an
example band. The
band 100 may comprise an elongated strip including a tail 102 and a head 104.
The tail 102 may
be wrapped around to engage with features on the head 104, which may thereby
form the band 100
into a loop. Furthermore, tension may be applied to the tail 102 to tighten
the band 100. The band
100 may be wrapped around one or more objects to constrain the movement of the
objects. For
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example, the band 100 may be wrapped around a bone of a person. In some
embodiments further
described herein, the band 100 may be wrapped around a sternum of a person
after surgery where
the sternum has previously been cut.
[0084] Additional features of the example band 100 may be more
readily understood in
reference to FIGS. 1B-1E, which illustrate various enhanced views of a head
104 of the hand 100.
The head 104 may define a top surface 109, at least two sidewalls, a bottom
surface, and an internal
cavity where the end of the tail 102 may be received. The internal cavity may
extend from the
entrance 106 to the exit 108. Looking at the cross-sectional view of FIG. 1E,
the entrance 106 and
exit 108 may be seen. In an embodiment, the entrance 106 may be located on the
top surface 109
of the band 100. In an embodiment, the exit 108 may be located on the top
surface 109 of the band
100. In an embodiment, the entrance 106 and the exit 108 are each located on
the top surface 109
of the band 100 such that the tail 102 enters and exits the head 104 via the
top surface 109. A
locking bar 110 which extends from one sidcwall of the head 104 to the other
sidcwall of the head
104, adjacent the top surface 109, may separate the entrance 106 from the exit
108.
[0085] The end of the tail 102 may be inserted through the entrance
106, extended into the
space between the pawl 112 and the locking bar 110, and extended through the
exit 108 (referred
to herein as the insertion direction). As the end of the tail 102 extends
toward the exit 108, the
pawl 112 may direct the tail 102 toward an exit ramp 118. A portion of the
tail 102 may contact
the exit ramp 118. The exit ramp 118 may be provided as a trough having a
thirty degree angle in
some embodiments, but other angles may be used for the exit ramp 118. The exit
ramp 118 may
be linearly sloped in some embodiments, but the exit ramp may have a curved
slope in other
embodiments. In either case, the exit ramp 118 may be configured to urge the
end of the tail 102
toward the top surface 109, and thus the exit 108, of the head 104. After the
end of the tail 102 has
been inserted through the internal cavity and slides over the exit ramp 118
and out of the exit 108,
tension may be applied to the tail 102 to further tighten the tail 102. Said
alternatively, the end of
the tail 102 may be pulled while maintaining the head 104 in a relatively
stationary position to
apply such tension.
[0086] Ridges 112A may be provided on the pawl 112, and these
ridges 112A of the pawl 112
may engage with ridges 202A (see FIG. 2A) on the top surface 109 of the tail
102 in some
embodiments. The engagement of the ridges may generally prevent the band 100
from being
untightened or from moving in the direction opposite the insertion direction.
To disengage the
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band 100, an operator may simply cut the band 100, making the band 100 easily
removable if
necessary.
[0087] The head 104 of the band 100 may include a top portion 114
and a bottom lock 120. A
gap 119 may be defined between the top portion 114 and the bottom lock 120. As
described further
herein, the gap 119 between the top portion 114 and the bottom lock 120 may be
used to receive a
portion of a fixation plate 1022 to restrain the movement of the band 100
relative to the fixation
plate 1022 (see FIG. 10B).
[0088] Furthermore, in some embodiments, the head 104 may include
pockets 116. The
illustrated embodiment includes two pockets 116, but any number of pockets may
be used. The
pockets 116 may be configured to assist in generating tension between the tail
102 and the head
104 of the band 100, as will be more fully explained herein.
[0089] In some embodiments, the bands 100 may be pre-bent or curved
at a pre-determined
radius. This may help facilitate maneuverability of the bands 100 through and
under the intercostal
spaces and under the posterior surface of the sternum.
[0090] FIGS. 2A-2D illustrate various enhanced views of a head of
another band. Looking at
FIG. 2A, a tail 202 having ridges 202A is illustrated on the left, and the
head 204 of the band is
illustrated on the right. As noted above, the end of the tail 202 may be
wrapped around and inserted
into an internal cavity extending from the entrance 206 to the exit 208 within
the head 204.
Looking at FIG. 2D, the end of the tail 202 may be inserted through the
entrance 206, extend
underneath the locking bar 210, and extend out through the exit 208. The
locking bar may include
ridges similar to the ridges 112A illustrated on the pawl 112 of FIG. 1E. As
illustrated in FIG. 2A,
as the end of the tail 202 extends out through the exit 208, the tail 202 may
rest on the exit ramp
218.
[0091] Additionally, the head 204 of the band may include a top
portion 214 and a bottom lock
220. A gap may be defined between the top portion 214 and the bottom lock 220.
As described
further herein, the gap between the top portion 214 and the bottom lock 220
may be used to restrain
the movement of the head 204 of the band relative to a fixation plate 1022
(see FIG. 10B). The
head 204 may be different from the head 104 of FIGS. 1A-1E in that only a
single locking bar 210
is provided without a separate pawl. Furthermore, the overall shape of the
head 204 may be more
rounded than the head 104. Additionally, the head 204 is provided without any
pockets 116 (see
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FIG. 1D). Additionally, the bottom lock 220 may be tapered to increase the
ease of installing the
head 204 in a window of a fixation plate 1022 (see FIG. 10B).
[0092] FIG. 3 illustrates an enhanced cross-sectional view of the
head 304 of another example
band. FIG. 3 also permits the tail 302 of the band to be seen. The end of the
tail 302 may be
wrapped around and inserted into an internal cavity extending from the
entrance 306 to the exit
308 within the head 304. Looking at FIG. 3, the end of the tail 302 may be
inserted through the
entrance 306, extend underneath the locking bar 310 but above the pawl 312,
and extend out
through the exit 308. The pawl 312 may include ridges 312A similar to the
ridges 112A illustrated
on the pawl 112 of FIG. 1E. Where this is the case, ridges may be provided on
the bottom surface
of the tail 302 so that the ridges of the tail 302 may engage with the ridges
312A of the pawl 312.
[0093] Additionally, the head 304 of the band may include a top
portion 314 and a bottom lock
320. A gap may be defined between the top portion 314 and the bottom lock 320.
As described
further herein, the gap between the top portion 314 and the bottom lock 320
may be used to restrain
the movement of the head 304 of the band relative to a fixation plate 1022
(see FIG. 10B). In the
head 304 of FIG. 3, the top portion 314 may be enlarged on both the entry side
(on the right) and
on the exit side (on the left) relative to the head 104 of FIGS. 1A-1E so that
the top portion may
have a larger interface surface with a fixation plate 1022 (see FIG. 10A).
[0094] FIGS. 4A-4D illustrate various enhanced views of a head 404
of another band. FIG.
4A also permits the tail 402 of the band and ridges 402A on the tail 402 to be
seen. The end of the
tail 402 may be wrapped around and inserted into an internal cavity extending
from the entrance
406 to the exit 408 within the head 404. Looking at FIG. 4D, the end of the
tail 402 may be
inserted through the entrance 406, extend underneath the pawl 412, and extend
out through the
exit 408. The pawl 412 may include ridges 412A similar to the ridges 112A
illustrated on the pawl
112 of FIG. 1E. Similar to other embodiments, the head 404 may include a top
portion 414 and a
bottom lock 420 that may create a gap configured to restrain the movement of
the head 404 of the
band relative to a fixation plate 1022 (see FIG. 10B). The exit ramp 418 (see
FIG. 4C) for the head
404 is also curved, unlike the exit ramp 118 of FIG. 1D.
[0095] FIGS. 5A-5B illustrate various enhanced views of another
example band. The end of
the tail 502 may be wrapped around and inserted into an internal cavity
extending from the entrance
506 to the exit 508 within the head 504. Looking at FIG. 5B, the end of the
tail 502 may be inserted
through the entrance 506, extend under the locking bar and above a pawl, and
extend out through
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the exit 508. The pawl may include ridges similar to the ridges 112A
illustrated on the pawl 112
of FIG. 1E. Similar to other embodiments, the head 504 may include a top
portion 514 and a
bottom lock 520 that may create a gap configured to restrain the movement of
the head 504 of the
band relative to a fixation plate 1022 (see FIG. 10B).
[0096] The head 504 may also include one or more pockets 516. In
the illustrated embodiment,
two pockets 516 are illustrated. The pockets 516 may provide a location where
alignment features
1150 (see FIG. 11B) of a tensioning gun 1138 (see FIG. 11A) may be received.
The pockets 516
may provide leverage for the tensioning gun 1138 as the tensioning gun 1138
applies tension to a
head 504.
[0097] Various fixation plates are also contemplated that may be
used to assist in securing two
severed halves of a severed sternum together. Fixation plates may comprise
materials and possess
features that permit the fixation plates to conform to the shape of the
underlying bone.
Furthermore, the fixation plates may disperse any stress generated by bands
across a greater
surface area on the underlying bone to prevent stress concentrations at
specific locations where the
bands are provided. FIG. 6A-6E illustrate various views of an example fixation
plate 622. The
fixation plate 622 may generally comprise an elongated body, similar in length
and width to a
portion of the human sternum. The fixation plate 622 may include at least two
rails 626 that extend
lengthwise. In an embodiment, the rails 626 may be connected to one another
via crossbars 628.
In another embodiment, the fixation plate 622 may comprise two rails 626 and
two crossbars 628
(one at each end ¨ see FIG. 7A). In an embodiment, the fixation plate 622 may
comprise two rails
626 and three crossbars 628. In another embodiment, the fixation plate 622 may
comprise two rails
626 and five crossbars 628. Any number of rails 626 and crossbars 628 are
contemplated herein.
The rails 626 and crossbars 628 may form one or more windows 624 (i.e. open
cavities). The
windows 624 may be configured to receive the head 104 of a band 100 (see FIG.
1A). Three
windows 624 are illustrated in FIG. 6A, but any number of windows 624 may be
included. In one
embodiment, the fixation plate 622 might resemble a ladder, consisting of
parallel longitudinal
rails 626 joined by multiple crossbars 628 occurring at various points along
the long axis of the
fixation plate 622, creating windows 624 within the central region of the
fixation plate 622. In an
embodiment, the fixation plate 622 may extend the entire length of the forward-
facing aspect of
the sternal anatomy from the manubrium to the xiphoid process, hut the
fixation plate 622 may be
configured to extend only a portion of this length in other embodiments.
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[0098] In some embodiments, the windows 624 are ovular or
elliptical in shape. In other
embodiments, the windows 624 are square or rectangular in shape. Any shape
known in the art
may be utilized herein. In some embodiments, the windows 624 may be positioned
and sized
differently from one another. That is, in the lengthwise direction, the
fixation plate 622 may not
be symmetrical. The fixation plate 622 may comprise two longer windows 624 on
one lengthwise
side of the contoured section 630 (explained below), one window 624 of
moderate length on the
other lengthwise side of the contoured section 630, and one shorter window 624
within the
contoured section 630, in an embodiment. Likewise, the widths of the various
windows 624 may
vary. One or more windows 624 may have a first width while one or more other
windows 624 may
have a second width.
[0099] As can be seen in FIG. 6B, the rails 626 may include a
protruding portion 626A that
extends partially into a window 624. This protruding portion 626A may extend
into the gap 119
(see FIG. 1E) formed between the top portion 114 and the bottom lock 120 of
the head 104 of a
band 100 (see FIG. 1E). When the protruding portion 626A extends into this gap
119 (see FIG.
1E), the engagement between the protruding portion 626A and the head 104 of
the band 100 (see
FIG. 1E) may restrict the movement of the head 104¨the head 104 may be
permitted to slide
along the length of the window (i.e. along the rails, left and right in FIG.
6A), but the engagement
may prevent the head 104 from moving perpendicular to the window (i.e. toward
the rails, up and
down in FIG. 6A). The engagement between the protruding portion 626A and the
head 104 may
keep the head 104 retained in the window 624, but, upon the application of
sufficient force, one
may remove the head 104 from the window 624 if desired. Alternatively, the
bottom lock 120 of
the head 104 of the band 100 may be keyed to passively insert through the
window 624 when the
head 104 is partially rotated (e.g. by rotating the bottom lock 120 by 90
degrees), and the bottom
lock 120 may then become locked underneath the rails 626 by partially rotating
the bottom lock
120 (e.g. by rotating the bottom lock 120 in a reverse direction by 90
degrees). The bottom lock
120 may be a twist lock in some embodiments. Where the fixation plate 622 is
used with a sternum,
the rails 626 of the fixation plate 622 may have a height (H) that is less
than 5 mm in some
embodiments. This reduced height (H) may make the fixation plate 622 have a
lower profile, with
the bands wrapped closer to the bone. This may reduce the amount that the band
needs to change
in direction, and this may increase the amount of surface area on the bone
that the band comes into
contact with. However, other larger or smaller sized fixation plates 622 may
be used at. the sternum.
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Furthermore, where the fixation plate 622 is used with a larger bone such as
femur, the fixation
plate 622 may have height that is 20 millimeters or greater.
[00100] The fixation plate 622 may also include one or more reinforced areas.
In the illustrated
embodiment, three reinforced areas are provided, with each of these reinforced
areas being at the
crossbars 628. As illustrated in the side view of FIG. 6C, the reinforced
areas may have increased
thickness and/or strength compared to other portions of the fixation plate
622. In some cases, the
reinforced areas may also assist in providing an end point to the windows 624
to restrict the
movement of a head 104 of a band 100. The reinforced areas that may provide
strength and
reinforcement and may disperse the structural load acting on the fixation
plate 622 across the
fixation plate 622 to minimize stress points.
[00101] In some embodiments, the reinforced areas may be provided at the
crossbars 628 to
provide rigidity against bending in the horizontal direction (up and down from
the perspective in
FIG. 6A) while permitting bending of the fixation plate 622 in the vertical
direction (lengthwise,
left and right from the perspective in FIG. 6A). By doing so, the fixation
plate 622 may be free to
bend in the vertical direction to conform to the shape of a sternum and may
allow the patient to
retail natural movement of the sternum. However, the reinforced areas may have
limited rigidity
against bending in the horizontal direction in other embodiments so that the
fixation plate 622 may
also be free to easily bend in the horizontal direction to conform to the
shape of a sternum.
[00102] As illustrated in FIGS. 6A, 6C, and 6D, the fixation plate 622 may
include a contoured
section 630. The contoured section 630 may be provided so that the fixation
plate 622 may more
easily conform to the shape of the underlying sternum. In an embodiment, the
bottom surface 632
of the fixation plate 622 may generally be linear, but the contoured section
630 may bow inwardly,
in a curved or angular manner, toward a top surface 621 of the fixation plate
622. For example,
the contoured section 630 may be configured to be placed over the sternal
manubrial junction or
the angle of Louis on the sternum in some embodiments. Additionally, a
contoured section 630
may be placed over the sternal body xiphoid junction. In some embodiments, the
fixation plate
622 may have areas of increased flexibility to allow it to better conform to
the specific anatomy of
a given patient at certain areas (e.g. the sternal manubrial junction, the
sternal body xiphoid
junction, etc.).
[00103] The bottom surface 632 of the fixation plate 622 may also include one
or more spikes
732A (see FIG. 7E) to assist in gaining traction between the fixation plate
622 and the severed
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sternum (see FIG. 7E). However, the bottom surface 632 may be free from any
spikes in some
embodiments. One or more cavities 634 may be provided in some embodiments at
the bottom
surface 632 of the fixation plate 622. The windows 624 and the cavities 634
may provide an open
architecture to allow for bodily fluids to flow through to permit proper
healing at a cut 1857 in the
severed sternum 1856 (see FIG. 18A). The radius R at the end of the windows
624 may have a
large size to ensure that the head 104 of a band 100 may slide the maximum
distance of the window
624. The fixation plate 622 may provide sufficient stiffness and rigidity to
buttress an injured bone
(e.g. the sternum) while providing sufficient ductility to conform to the
shape and contours of the
underlying bone.
[00104] Another alternative fixation plate 722 is also illustrated in FIGS. 7A-
7E. Similar to the
fixation plate 622 of FIGS. 6A-6E, the fixation plate 722 may include a window
724. The fixation
plate 722 may include rails 726 that assist in forming the window 724. The
window 724 may be
configured to receive the head 104 of a band 100 (see FIG. 1A). As can be seen
in FIG. 7B, the
rails 726 may include a protruding portion 726A that extends into the window
724. This protruding
portion 726A may extend into the gap 119 (see FIG. 1E) formed between the top
portion 114 and
the bottom lock 120 of the head 104 of a band 100 (see FIG. 1E) to restrict
the movement of the
head 104. The protruding portion 726A may operate similar to the protruding
portion 626A of
FIG. 6B.
[00105] As illustrated in FIG. 7D, the fixation plate 722 has a bottom surface
732, and this
bottom surface 732 is flat in the fixation plate 722 of FIG. 7D. However, in
other embodiments,
the bottom surface 732 may have a concave shape, a convex shape, or some other
non-flat shape.
For example, the bottom surface 732 may be slightly concave so that the
fixation plate 722 may
follow the natural anatomic radius of the sternum. Furthermore, as illustrated
in FIG. 7D, the
fixation plate 722 may have spikes 732A on the bottom surface 732 in some
embodiments. The
spikes 732A may have sharp tips or dull tips in some embodiments, and the
spikes 732A may be
configured to engage bone at the sternum to minimize any noticeable pain for
the patient. A single
spike may be provided in some embodiments, or a plurality of smaller spikes
may be used.
Furthermore, the spikes 732A may possess a wide variety of shapes. In the
illustrated embodiment,
the spikes 732A have a rectangular pyramid shape. However, the spikes may be
cone shaped, in
another pyramid shape, in the shape of a triangular prism, asymmetrically
shaped, etc. Likewise,
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in place of spikes 732A, the plate may be textured with bunt pegs or some
other feature to permit
improved traction on the bottom surface 732.
[00106] FIG. 8A-8D illustrate various views of another example fixation plate
822. The
fixation plate 822 may include rails 826 that assist in forming windows 824.
This fixation plate
822 may also have protruding portions 826A, crossbars 828 having reinforced
areas, and a bottom
surface 832 that may operate in generally the same manner as similar features
described above.
The fixation plate 822 may have a flatter shape than the fixation plate 622 of
FIG. 6A as the fixation
plate 822 may be provided without any contoured section 630.
[00107] FIG. 9A-9D illustrate various views of another example fixation plate
922. The
fixation plate 922 may include rails 926 that assist in forming windows 924.
This fixation plate
922 may also have protruding portions 926A, crossbars 928 having reinforced
areas, and a bottom
surface 932 that may operate in generally the same manner as similar features
described above.
Like the fixation plate 622 of FIG. 6C, the fixation plate 922 may include a
contoured section 930
to permit the fixation plate 922 to accommodate the shape of certain features
on the sternum.
However, certain features on the fixation plate 922 may have a different shape
and/or size than the
fixation plate 622. For example, the contoured section 930 possesses a
different shape than the
contoured section 630 of the fixation plate 622. Additionally, the reinforced
areas may have
narrower width than the reinforced areas of the fixation plate 622 of FIG. 6D.
Furthermore, the
fixation plate 922 may have a low profile with the height of the rails 926
(see FIG. 911) being
smaller than rails of most other embodiments, and this smaller height may
allow a band installed
in the fixation plate 922 to be provided closer to the bone and reduce any
change in direction for
an installed band. The height of the rails 926 may be the same as the height
(H) of the rails 626 in
FIG. 6B.
[00108] The fixation plate 922 may contain nodes in some embodiments. These
nodes may be
large enough to span the sternum of the patient, and the nodes may contain a
feature that may
accept the head or tail of an independent fasteners such as but not limited to
bands, screws, or
cable ties. Furthermore, in some alternative embodiments, the fixation plate
may have bands
integrated into the fixation plate itself so that the installer will not be
required to attach the bands
to the fixation plate.
[00109] A fixation plate may be selected that may best conform to the size and
shape of the
sternum of a given patient, and the provision of fixation plates having
different sizes and shapes
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may be beneficial to accommodate this. After a fixation plate has been
selected, the head of a band
may be removably attached to the fixation plate within a window in the
fixation plate. FIG. 10A
illustrates a top view of an example fixation plate 1022 with an example band
1000 assembled to
the fixation plate 1022. As can be appreciated, the bottom lock 1020 of the
head 1004 may be
inserted into the window 1024. Due to the engagement between the head 1004 and
the window
1024, the head 1004 may be permitted to shift along the track formed by the
window 1024. For
example, in the embodiment illustrated in 10A, the head 1004 may move up and
down along the
track formed by the window 1024. Furthermore, in the embodiment illustrated in
10A, the
engagement of the head 1004 may prevent the head 1004 (1) from moving to the
left or the right;
(2) from moving into or out of the page (unless sufficient force is provided
to remove the head
1004 from the window 1024). The head 1004 may be shaped in a manner that
permits the head
1004 to rotate as it is retained in the window 1024. For example, in the
illustrated embodiment of
FIG. 10E, the head 1004 is rotated at an angle, and this may be beneficial to
form an X-pattem, to
fit to the anatomy of the patient, to apply forces to the sternum in other
directions, etc. Where
multiple bands 1000 are installed in the window 1024, the bands 1000 may be
permitted to slide
and pivot independently of each other in some embodiments. Furthermore, FIGS.
10B-10D
illustrate a cross-sectional view of the fixation plate 1022 and band 1000 of
FIG. 10A about the
line H'-H'.
[00110] Looking at FIG. 10B, various features of the fixation plate 1022 and
the band 1000 may
be seen. The band 1000 may include a head 1004 and a tail 1002. Similar to the
embodiments of
fixation plates discussed above, the fixation plate 1022 may include rails
1026 that assist in
forming windows 1024. The fixation plate 1022 may also include a protruding
portion 1026A that
extends into a window 1024.
[00111] This protruding portion 1026A may extend into a gap formed between the
top portion
1014 and the bottom lock 1020 of the head 1004 of a band. When the protruding
portion 1026A
extends into this gap, the engagement between the protruding portion 1026A and
the head 1004 of
the band 1000 may have restrict the movement of the head 1004¨the head 1004
may be permitted
to slide along the window 1024 (left and right in FIG. 6A), but the engagement
may prevent the
head 1004 from moving perpendicular to the window 1024 (up and down in FIG.
6A). The
engagement between the protruding portion 1026A and the head 1004 may keep the
head 1004
retained in the window 1024, but, upon the application of sufficient force,
one may remove the
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head 1004 from the window 1024 if desired. The head 1004 may be snapped in
with or without
aid on an external tool with forced pressure in some embodiments. The bottom
lock 1020 of the
head 1004 may be made of elastic material in some embodiments to permit the
bottom lock 1020
to deform a sufficient amount so that the bottom lock 1020 may extend under
the windows 1024.
The head 1004 may be attached to the fixation plate 1022 within the window
1024 at a location
proximate to an intercostal space 1660 (see FIG. 16A) or the head 1004 may be
attached and then
slid to an appropriate location.
[00112] In some embodiments, the bottom lock of the head may have a circular
shape, and the
width of the bottom lock may be a diameter of the bottom lock in that case.
Examples of such a
circularly shaped bottom lock are illustrated in FIGS. 2A, 4A, and 5A.
However, in other
embodiments, the bottom lock may possess other shapes. Where a circularly
shaped bottom lock
is utilized, the width of the bottom lock may be greater than the width of the
window 1024 (e.g.
the width runs left and right in FIG. 10A). Where this is the case, the head
1004 may be attached
to the fixation plate 1022 between the rails 1026 within a window 1024 by
applying a force on the
head 1004 to urge the bottom lock towards the rails 1026, and the bottom lock
may be configured
to bend elastically upon application of the force to permit the bottom lock to
extend through the
window 1024.
[00113] In other embodiments, the bottom lock may have a non-circular shape
(e.g. oval shaped,
rectangularly shaped, etc.), and the bottom lock may define a minimum width
and a maximum
width. An example of this is illustrated in the bottom lock 120 of FIGS. 1A-
1E. The bottom lock
120 may have a maximum width (W1) as illustrated in FIG. 1C, and the bottom
lock 120 may have
a minimum width (W2) as illustrated in FIG. 1D. The minimum width (W2) of the
bottom lock
120 may be less than the width of the window 1024, and the maximum width (W2)
of the bottom
lock 120 may be greater than the width of the window 1024. Where this is the
case, the head 1004
may be attached to the fixation plate 1022 by rotating the head 1004 so that
the bottom lock 120
may fit through the window 1024 (i.e. so that the width of the bottom lock 120
becomes less than
the width of the window 1024). Once the bottom lock 120 has been received in
the window 1024,
the head 1004 may be rotated again so that the bottom lock 120 may be retained
within the window
1024. Once rotated, the width of the bottom lock 120 may be greater than the
width of the window
1024. Other bottom locks 120 are also contemplated. For example, the bottom
lock 120 may have
a portion that is expandable and retractable, allowing the bottom lock 120 to
be retracted so that it
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may be inserted into a window 1024 and allowing the bottom lock 120 to be
expanded so that it
may be retained in the window 1024.
[00114] Looking now at FIG. 10D, the tail 1002 may be looped around into the
internal cavity
extending from the entrance 1006 to the exit 1008, extending along the path of
the arrows
illustrated in FIG. 10D (the insertion direction). The end of the tail 1002
may be inserted through
the entrance 1006, above the pawl 1012 and below the locking bar 1010, through
a binding area
1036, and out of the exit 1008. The tail 1002 may be retained at the binding
area 1036 as the pawl
1012 and the locking bar 1010 may be urged against the tail 1002. A buckling
action may be
created at the binding area 1036, and this may permit further portions of the
tail 1002 to be inserted
through the internal cavity (e.g. along the path of the arrows) without
permitting reverse movement
of the tail 1002 in the opposite direction.
[00115] While the fixation plate 1022 is effectively affixed to bone using
bands 1000 in the
illustrated embodiment, the fixation plate 1022 may also be affixed to bone
with cerclage wire or
other cabling techniques whereby cerclage wire or cable passes over and around
the fixation plate
1022 as the fixation plate 1022 rests on the bone. Where this is done, the
fixation plates may
include slots that may be configured to receive wire or other cables. The
fixation plate 1022 and
one or more bands 1000 may be attached together before being inserted into the
body of the patient
in some embodiments, but the bands 1000 may simply be attached to the fixation
plate 1022 once
the fixation plate 1022 has been inserted into the body of the patient in
other embodiments.
[00116] While the bands may be manually installed, tensioned, and then cut, it
may be
detrimental to perform these tasks manually for several reasons. First, manual
performance of these
tasks can lead to human error. The fixation plate may not be installed
properly or the bands may
not be tightened to an appropriate tension, and this may cause the patient to
heal improperly.
Second, manual performance of the tasks will be less user-friendly. Where the
fixation plate is
being installed at a severed sternum, one or more installers would need to
maintain the two severed
sternum halves in an appropriate position, they would need to maintain the
fixation plate at the
appropriate position, and they would need to install bands to retain the
fixation plate in the
appropriate position. This may be difficult to do at the same time, increasing
frustration for the
installers and leading to an increased risk of error during installation.
Third, manual performance
of the tasks may very time consuming for installer(s).
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[00117] Tensioning guns are contemplated that may be used to apply tension to
bands until a
desired tension level is reached. Once the desired tension level is reached,
the tensioning gun may
cut the band. The tensioning gun may reduce human error by maintaining a
consistent amount of
tension in each band. Manual tensioning places undue reliance on user judgment
based on prior
experience, visualization or tactile feel, and approximations or guesswork
from the installer may
lead to errors. The tensioning gun may be easier for installers to operate
eliminating any
approximations or guesswork from the installer as to whether the tension level
is appropriate. By
cutting the bands automatically after the desired tension is obtained, this
alleviates the need for the
installer to perform this task separately. The tensioning gun may also tighten
the bands up more
quickly than manual tightening of bands.
[00118] FIG. 11A illustrates a perspective view of an example tensioning gun
1138 being used
to generate tension on an example band 1100, and FIG. 11B illustrates an
enhanced view of the
tensioning gun 1138 and band 1100 of FIG. 11A.
[001191 Looking first at FIG. 11A, various features of the tensioning gun 1138
may be seen.
The tensioning gun 1138 may tension the bands 1100 to precise levels. The
tensioning gun 1138
may include a handle 1140 and a actuator lever 1142. One may hold the handle
1140 as he or she
is using the tensioning gun 1138. Further, the actuator lever 1142 may be
compressed when the
user desires to provide tension to the band 1100. In some embodiments, upon
the desired tension
being reached, the tensioning gun 1138 may cease providing further tension,
and the properties of
the band may maintain this tension. For example, the band, the pawl, and the
locking bar and any
ridges thereon may generally maintain the tension at this level, but other
locking mechanisms may
be used to prevent the tension on the band 1100 from being released. The trim
system 1148 may
automatically be actuated so that the band 1100 may be cut. However, in other
embodiments, a
separate button may be provided that may be pressed when the user desires to
actuate the trim
system 1148, and the user may press this separate button once the desired
tension is obtained. The
actuator lever 1142 may be provided with a high mechanical advantage ratio so
that it may be used
more easily.
[00120] Additionally, the tensioning gun 1138 may include a barrel 1141 with
one or more
features provided therein. The barrel 1141 may contain an internal chamber
that generally runs
along the length of the barrel 1141. The barrel 1141 may include a trim system
1148 disposed
proximate to the end of the barrel 1141. Furthermore, a safety lock 1144 is
provided on the barrel
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1141. The safety lock 1144 may be provided in the form of a switch, a lever,
etc., and the safety
lock 1144 may prevent premature or unintended cutting of bands 1100. The
safety lock 1144 may
be in a locked state to prohibit tension from being applied via the tensioning
gun 1138 and/or to
prevent the trim system 1148 from cutting the bands 1100. Furthermore, the
safety lock 1144 may
be in an unlocked state to permit tension to be applied via the tensioning gun
1138 and/or to permit
the trim system 1148 to cut the bands. While the safety lock 1144 is provided
on the barrel 1141
in FIG. 11A, the safety lock 1144 may be provided at another location in other
embodiments. The
safety lock 1144 may be provided on the left side, the right side, on both
sides, on the rear, etc. of
the tensioning gun 1138. In other embodiments, a secondary switch, lever, etc.
may be added to
the tensioning gun 1138 to actuate cutting.
[00121] Furthermore, a tension limit system 1252 (see FIG. 12A) may be
provided. This tension
limit system 1252 may be provided in the barrel 1141 in some embodiments, but
the tension limit
system 1252 may be provided at other locations. A knob 1146 may be provided to
permit the
desired tension level to be adjusted by a user. A top view showing a similar
knob 1246 is also
provided in FIG. 12A. Adjustment of the knob 1146 or the knob 1246 may cause a
corresponding
adjustment to be made at the tension limit system 1252, preventing tension
from being applied
past a maximum level. While a knob 1246 may be used as illustrated, other
clutch mechanisms
may be used in other embodiments to limit the amount of tension that may be
applied to the bands.
[00122] In some embodiments, the tension limit system 1252 may include a
spring-loaded
probe. The spring-loaded probe may extend proximate to the end of the barrel
1141, and the spring-
loaded probe may extend proximate to the trim system 1148 (see FIG. 11A). The
spring-loaded
probe may require depression of the probe into a corresponding barrel cavity
before the trim system
1148 may cut any band. This tension limit system 1252 may prevent premature or
unintentional
band cutting. The tension limit system 1252 may also allow cutting only when
the tip of the barrel
1141 and the cutting blade 1554 (see FIG. 15) are seated at the lowest and
most optimal position
to ensure a flush cut of the band.
[00123] Looking now at FIG. 11B, the engagement between the tensioning gun
1138 and the
head 1104 of a band 1100 may be seen. The tensioning gun 1138 may include two
alignment
features 1150 extending from the barrel 1141, but any number of alignment
features 1150 may be
used. A channel 1151 may be provided between the two alignment features 1150
where the tail of
the band 1100 may be received and positioned within the barrel 1141 of the
tensioning gun 1138.
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The channel 1151 may correspond to the cross-sectional shape of the band 1100
so that the free
end of the tail for the band 1100 may be precisely fed into the channel 1151
in a controlled manner.
The tensioning gun 1138 may receive the excess portion of the band 1100
without unduly altering
the angle of the band 1100 ______ by doing this, the amount of stress and
strain acting on the band
1100 and tensioning gun 1138 may he reduced, and the amount of tension that
must he applied by
the tensioning gun 1138 may be reduced.
[00124] The head 1104 may have pockets 116 (see FIG. 1D) that are configured
to receive the
alignment features 1150. As the tensioning gun 1138 is applying tension, the
alignment features
1150 may be urged against a wall in a pocket 116 to provide leverage. The
alignment features 1150
may ensure that the tensioning gun 1138 is appropriately positioned relative
to the bands 1100.
This positioning may help ensure that that the head 1104 of the band 1100 is
maintained in a
stationary position as tension is applied. By ensuring this proper
positioning, the tension level in
installed bands 1100 may be consistent, and errors may be avoided. By applying
tension to the
bands 1100 (e.g., by pulling the tail of the band 1100 into the tensioning gun
1138 via actuation of
the actuator lever 1142 while maintaining the head 1104 of the band 1100 in a
stationary position),
the bands 1100 may tighten around the fixation plate 1022 (see FIG. 10A) and
bone and cause the
fixation plate 1022 to conform to the shape of the underlying sternum.
[00125] Upon continuous actuation of the actuator lever 1142, the band 1100
may advance
through the channel 1151. As more portions of the band 1100 have advanced into
the channel
1151, more tension may be applied to the bands 1100 to oppose further
advancement of the bands
1100 in the insertion direction. This increased tension may occur due to the
engagement between
the notches 112A in the head 104 and notches 102A of the tail 102 (see, e.g.,
FIG. 1E). This
increased tension may also occur based on other forces acting on other
portions of the loop formed
by the tail 102 as the loop extends around the bone and the fixation plate.
[00126] The tensioning gun 1138 may be removed quickly and easily, and the
tensioning gun
1138 may only grip a band 1100 when the actuator lever 1142 is being actuated.
To the extent an
installer wishes to apply further tensioning after using the tensioning gun
1138 once, the tensioning
gun 1138 may be subsequently reintroduced over the exposed free tail end of a
band 1100.
[00127] In some embodiments, the tensioning gun 1138 may contain other
features such as a
battery operated light source such as LED or a fiber optic light source.
Additionally, the tensioning
gun 1138 might contain suctioning and/or irrigating capability or have a mount
or fitting where
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such capabilities may be attached to the device. Where this is the case,
batteries may be provided
in the tensioning gun 1138, or some other power source may be included in the
tensioning gun
1138. While various features of the tensioning gun 1138 are mechanically
actuated in the
illustrated embodiment of FIGS. 11A and 11B, the tensioning gun 1138 may
include electronic
circuitry in some embodiments to set the tension limit, to determine the
applied tension, to actuate
the trim system, etc. In some embodiments, the tensioning gun 1138 may include
a memory to
store computer readable instructions, and the tensioning gun 1138 may also
include a user interface
to permit user inputs.
[001281 Other view of an example tensioning gun are also provided in FIGS. 12A-
12B. FIG.
12A illustrates a top view of an example tensioning gun 1238, and FIG. 12B
illustrates a side view
of the tensioning gun 1238 of FIG. 12A. Similar to the tensioning gun 1138,
the tensioning gun
1238 may have a handle 1240, a actuator lever 1242, a safety lock 1244,
alignment features 1250,
a channel 1251, and a tension limit system 1252. FIG. 12A illustrates a top
view of the tensioning
gun 1238, permitting the tension limit system 1252 to be seen. In some
embodiments, no top
surface is provided for the tensioning gun 1238. This may be beneficial to
permit cut portions of a
band to be easily removed from the tensioning gun 1238. Cut portions of a band
may be easily
removed from the tensioning gun 1238 upon deactivation or release of the
actuator lever 1142.
However, a top surface may be provided in other embodiments to contain the
features of the
tensioning gun 1238 (e.g. the tension limit system 1252).
[00129] Further features of an example tensioning gun are provided in FIGS.
13A-13B. FIG.
13A illustrates a perspective view of an example tensioning gun 1338 being
used to generate
tension on an example band 1300 where a sidewall of the tensioning gun 1338 is
made transparent,
and FIG. 13B illustrates an enhanced view of the tensioning gun 1338 of FIG.
13A. Looking at
FIG. 13B, the tail of the band 1300 may be looped around and then the free end
of the tail may be
inserted through the channel 1251 (see FIG. 12A) formed in the tensioning gun
1338 between the
alignment features 1250 (see FIG. 12A). Excess portions of the tail may extend
through the channel
1251. Once cut, one may remove the excess portions of the tail through an open
top surface.
[00130] FIG. 13B permits portions of a trim system 1348 provided in the
tensioning gun 1338
to be seen. The trim system 1348 may be provided with a cutting blade 1354,
and the trim system
1348 may be configured to receive an indication of whether or not the tension
limit has been
reached at the tension limit system 1252 (see FIG. 12A). Upon the tension
limit being reached, the
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trim system 1348 may be activated automatically so that the cutting blade 1354
may cut the excess
portions of a tail. The cutting blade 1354 may cut the tail so that no jagged
edges remain. The trim
system 1348 may be located proximate to the end of the barrel 1141. Placement
of the trim system
1348 at this location may assist in ensuring a flush cut of the band so no
portion of the remaining
band may irritate overlying tissues and/or be palpated by the patient and
potentially cause
discomfort.
[00131] The tensioning gun 1338 may apply tension to a band 1300 prior to and
at the time of
cutting using a cam mechanism 1355 housed within the tensioning gun 1338. This
cam mechanism
1355 may be part of the tension limit system 1252 (see FIG. 12B) in some
embodiments. The
cutting blade 1354 may be activated while the band 1300 is under tension, and
this may permit the
cut to be performed with less force than if the band 1300 in not tensioned.
Another consequence
of a band 1300 being cut while under tension is that the band 1300 recoils
slightly after cutting.
This may cause retraction of the tail 102 (see FIG. 1E) of the band 1300
protruding though the
internal cavity of the head 104 (see FIG. 1E). This retraction may keep the
cut end of the band
1300 flush to or beneath the top surface of a head 104 (see FIG. 1E).
[00132] The tensioning gun may apply tension to a band to tighten loops formed
by the band.
FIG. 14 illustrates an enhanced, cross sectional view of an example tensioning
gun being used to
generate tension on a band 1400. As illustrated, the tail 1402 of the band
1400 may proceed in a
manner similar to that shown in FIG. 10D. The tail 1402 may be inserted
through the entrance
1006 (see FIG. 10D), through a binding area 1036 (see FIG. 10D) where the tail
1402 may be
constrained between a pawl 1012 (see FIG. 10D) and a locking bar 1010 (see
FIG. 10D), and out
of the exit 1008 (see FIG. 10D). Once the end of the tail 1402 has been
inserted in this manner,
the tail 1402 may be provisionally tensioned further and/or the end of the
tail 1402 may be inserted
into the tensioning gun for further tensioning. The alignment features 1450
operate similarly to
other alignment features discussed herein to assist in engaging the head of
the band 1400.
[00133] FIG. 15 illustrates a schematic view of an example cutting blade 1554
of a trim system
for a tensioning gun being used to cut an excess portion of a tail 1502 for a
band. The trim system
may be provided with a cutting blade 1554, and the trim system may be
configured to receive an
indication of whether or not the tension limit has been reached at the tension
limit system 1252
(see FIG. 12A). Upon receiving an indication that the tension limit has been
reached, the trim
system may be configured to cause the cutting blade 1554 to be activated to
cut the excess portion
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of the tail 1502. The trim system and the cutting blade 1554 may be configured
to cut the tail 1502
to avoid the creation of any jagged edges at the cut end. Jagged edges may
cause pain and/or
discomfort for a patient. A band 1500 may be fed through the channel 1151 (see
FIG. 11B) so that
a perpendicular relationship may be maintained between the band 1500 and the
cutting blade 1554
to ensure a clean and straight cut with no jagged edges. The cutting blade
1554 may be slightly
curved or radially shaped to avoid any sharp edge on the end of the tail 1502
from extending
through the exit 108 (see FIG. 1E) of the head 104 of a band to prevent soft
tissue irritation.
[00134] Once assembled, the fixation plate may be positioned at the sternum
above a cut on the
sternum, and bands may be looped around to urge severed halves of the sternum
together. FIG.
16A illustrates a front view of an example fixation plate 1622 assembled at a
sternum 1656, and
FIG. 16B illustrates a perspective view of the fixation plate 1622 of FIG. 16A
assembled at the
sternum 1622. As illustrated, the fixation plate 1622 may be positioned
adjacent to the sternum
1656, and bands 1600 may be wrapped around the sternum 1656 and secured in a
loop. A band
1600 may proceed through the intercostal spaces 1660 formed between two ribs
1658 on one side
of the sternum 1656. After that, the band 1600 may be wrapped around the rear
of the sternum
1656 so that the band 1600 may proceed through an intercostal space 1660 on
the opposite side of
the sternum 1656. The band 1600 may then be inserted into the internal cavity
in head of the band
1600 so that a loop may be formed. Alternatively, instead of wrapping the
bands 1600 around the
sternum 1656, a pilot hole may be created in the sternum 1656 where the bands
1600 may be
inserted, and the bands 1600 may form a loop extending through the pilot hole.
[00135] The bands 1600 illustrated in FIGS. 16A-16B are provided in a level
manner, with the
bands 1600 proceeding through corresponding intercostal spaces 1660 on
opposite sides of the
sternum 1656. However, the bands 1600 may be installed in other ways, with the
bands 1600
extending diagonally. For example, some may find it desirable to install two
bands 1600 in an X-
pattern. Further, bands 1600 are provided with only one band 1600 inserted in
each intercostal
space 1660, but additional bands 1600 may be provided in a single intercostal
space 1660 in other
embodiments. Additionally, as shown in FIG. 16A, more than one head may be
received in a single
window 1624 of the fixation plate 1622. In FIG. 16A, one head is received in
the top window
1624, two heads are received in the middle window 1624, and one head is
received in the bottom
window 1624. In other embodiments, only one head may be received in each
window 1624, or
additional heads may be inserted into a single window.
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[00136] While FIGS. 16A-16B show the fixation plate and bands installed on a
sternum, a
tensioning gun may be used to improve the installation process for the
fixation plate and bands.
FIG. 17 illustrates a perspective view of an example tensioning gun 1738 being
used to assist in
securing an example fixation plate 1722 to the sternum of a patient.
[00137] Similar to the bands and fixation plates discussed above, the bands
1700 may be
inserted through intercostal spaces 1760 between ribs 1758 of the patient to
form a loop, and the
head of these bands 1700 may be installed at a fixation plate 1722. The end of
the bands 1700 may
be inserted into a tensioning gun 1738, and the tensioning gun 1738 may apply
tension to the bands
until a tension limit has been reached. In the illustrated embodiment,
gripping jaws 1725 and a
travel limiter 1725A are provided. The gripping jaws 1725 may pull on the band
1700 and tighten
the band 1700 to a predetermined tension associated with placement of the
travel limiter 1725A.
However, in other embodiments, other mechanisms may be provided to apply
tension to the band
1700 and/or the tension limit may be implemented without using a travel
limiter 1725A. Upon the
tension limit being reached, the amount of tension applied by the tensioning
gun 1738 may be
maintained. With the tension at this level, the trim system 1548 (see FIG. 15)
within the tensioning
gun 1738 may cause the cutting blade 1554 (see FIG. 15) to cut the excess
portion of the band
1700. In some embodiments, the bands 1700 may be provisionally tensioned after
the bands 1700
are formed into loops. Where provisional tensioning is performed, the loops
formed by the bands
1700 may be tightened to some degree while still leaving some slack in the
loops. By provisionally
tensioning bands, proper positioning of the severed halves of the sternum, the
fixation plate 1722,
and the bands 1700 may be ensured before tension is applied via the tensioning
gun 1738.
However, in other embodiments, provisional tensioning may not be performed.
Tensioning of the
bands 1700 with the tensioning gun 1738 may simultaneously compress the
fixation plate 1722
and bone components together to effectively form a splint that may provide
adequate stability for
healing. The fixation plate 1722 may provide sufficient stiffness and rigidity
to buttress the injured
bone while providing sufficient ductility to conform to the shape and contours
of the underlying
bone (e.g. the sternum) upon the tensioning of the bands 1700.
[00138] Skipping ahead to FIG. 21, an alternative tensioning gun 2138 is
illustrated. The
tensioning gun 2138 may take on the form of a "trigger-pull- shape similar to
a handgun. The
tensioning gun 2138 may include a rotatable knob 2146 on the body 2145 of the
tensioning gun
2138, and the rotatable knob 2146 may be located on the end of the tensioning
gun 2138 opposite
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the aperture 2151. The tensioning gun 2138 may include a handle 2140 and an
actuator lever 2142.
When twisted, the rotatable knob 2146 may operate to adjust the tension
setting such that a
desirable amount of tension may be generated in a band 1300 when a user
depresses the actuator
lever 2142. Further, a switch 2153 may also be included. The switch 2153 may
enable the
tensioning gun 2138 to alternate between a tensioning mode and a cutting mode.
Where the switch
2153 is in a tensioning mode, the tensioning gun 2138 may tighten the band
1300 being fed through
the aperture 2151 on the distal end of the barrel 2141 when a user squeezes
and depresses the
actuator lever 2142. Once the tension in band 1300 reaches a desirable or pre-
determined level,
the switch 2153 may be used to change from the tensioning mode to the cutting
mode. In the
cutting mode, a user may depress the actuator lever 2142 to cut the tensioned
band 1300. The
resulting band 1300 may be neatly flush to or beneath the top surface of a
head 104 (see FIG. 1E).
[00139] Looking now at FIG. 22, another alternative tensioning gun 2238 is
illustrated. The
tensioning gun 2238 may take the form of a "linear-pull" mechanism shaped
similarly to a syringe.
In such an embodiment, the actuator lever 2242 may take on a more linear
movement profile, and
the actuator lever 2242 may function to tension a band 1300 when the user
pulls the actuator lever
2242 backwards along a slider track 2255 in a direction away from the aperture
2251. The slider
track 2255 may be provided on the barrel 2241 of the body 2245 for the
actuator lever 2242. Once
the band 1300 reaches the tension limit, a switch 2253 may be utilized to
switch the tensioning
gun 2238 from a tensioning mode to a cutting mode. In the cutting mode, the
user may cut the
tensioned band 1300 by pulling the actuator lever 2242 back along the slider
track 2255, and the
resulting band 1300 may be neatly flush to or beneath the top surface of a
head 104 (see FIG. 1E).
The tensioning gun 2238 illustrated in FIG. 22 may be a highly intuitive tool,
and it may be a
disposable, single-use tool in some embodiments. However, the tensioning gun
2238 and other
tensioning guns provided herein may be durable tools that may be intended for
repeated use in
other embodiments.
[00140] The actuator lever 2142 of FIG. 21 and the actuator lever 2242 of FIG.
22 may be
configured to cause both the actuation of the cutting blade and the
application of tension to the
band, and the switch 2153, 2254 may be used to control the mode that the
actuator lever is in.
However, tensioning guns may switch between a cutting mode and a tensioning
mode in other
ways in other embodiments. For example, the tensioning gun may alternate
between the tensioning
mode and the cutting mode each time that the actuator lever is compressed.
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[00141] FIGS. 18A-18C provide another illustration of the fixation plate being
installed at a
cut sternum to assist in restricting two severed halves of the cut sternum.
FIG. 18A illustrates a
perspective view of an example fixation plate being positioned against a cut
sternum. FIG. 18B
illustrates a perspective view of the fixation plate of FIG. 18A with a band
being assembled to the
fixation plate, in accordance with some embodiments discussed herein. FIG. 18C
illustrates a
perspective view of the fixation plate of FIG. 18A with a tensioning gun being
used to tension and
cut bands, in accordance with some embodiments discussed herein.
[00142] As illustrated in FIG. 18A, the sternum 1856 may include a cut 1857,
and two severed
halves of the sternum 1856 may be provided on opposite sides of the cut 1857.
With the two
severed halves of the sternum 1856 being adjusted to the appropriate position,
the fixation plate
1822 may be provided at the sternum 1856 above the cut 1857. As illustrated in
FIG. 18B, a spring
1859 may be provided at the fixation plate 1822, and the spring 1859 may
assist in urging the
fixation plate 1822 against the sternum 1856 to conform the shape of the
fixation plate 1822 to the
shape of the sternum 1856. Manubrial extensions may be provided in the
fixation plate 1822 at the
upper portion of the fixation plate 1822 to enable the fixation plate 1822 to
easily conform to
features at the manubrium of the sternum. Furthermore, the spring 1859 may
have small wires that
may extend through small holes in the sternum. These wires may extend from the
top side of the
sternum through the sternum to the bottom side of the sternum, and the wires
may form a loop that
may be tightened at the bottom side of the sternum. The head of a band 1800
may be installed
within a window within the fixation plate 1822, and the band 1800 may be
wrapped around the
sternum 1856 through intercostal spaces 1860 between the ribs 1858 of a
patient to form a loop as
described herein. This band 1800 may be wrapped around using instruments as
illustrated in FIG.
18B. but this may instead be done by hand in other embodiments. Furthermore,
as illustrated in
FIG. 18C, a tensioning gun 1838 may be used to apply tension to the bands 1800
and to remove
excess portions of the bands 1800. Tensioning of the bands 1800 may
simultaneously compress
the fixation plate 1822 and bone components together to effectively form a
splint that may provide
adequate stability for healing. The fixation plate 1822 may provide sufficient
stiffness and rigidity
to buttress the injured bone while providing sufficient ductility to conform
to the shape and
contours of the underlying bone (e.g. the sternum) upon the tensioning of the
bands 1800. The
fixation plate 1822 may disperse stress over a larger surface area of the bone
components than the
bands 1800 applied by themselves.
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[00143] In some embodiments, a surgical drain assembly may be provided
alongside a fixation
plate. Surgical drain assemblies may be beneficial in open heart procedures
with sternotomy, but
the surgical drains may be used for other procedures and may be used alongside
bones other than
the sternum. Surgical drain assemblies may remove excess fluid such as blood
that may collect
near a surgical site. If excess fluid is not removed, this excess fluid may
become infectious posing
serious risk to the health of the patient while retarding or preventing
recovery. Surgical drains may
be provided on a temporary basis in some embodiments, and the surgical drains
may be removed
once the surgical site has sufficiently healed.
[00144] FIG. 19A illustrates a bottom view of an example surgical drain
assembly 1962, FIG.
19B illustrates a side view of the surgical drain assembly 1962. and FIG. 19C
illustrates a
schematic view of the surgical drain assembly 1962 of FIG. 19A having an
internal cavity 1972.
As illustrated in FIG. 19A, the surgical drain assembly 1962 may include a
drain body 1964. The
drain body 1964 may generally have a similar shape to a fixation plate that
the drain body 1964 is
being used with in some embodiments. However, the drain body 1964 may differ
in size and/or
shape from the fixation plate in other embodiments. The drain body 1964 is
configured to have a
similar size and shape as the fixation plate 822 of FIGS. 8A-8D so that the
drain body 1964 may
easily be attached to the fixation plate 822.
[00145] The drain body 1964 may include protrusions 1966 extending downwardly
from a
bottom surface of the drain body 1964. The protrusions 1966 may be configured
to engage with a
portion of the windows 824 of the fixation plate 822 (see FIG. 8A) to restrict
the movement of the
drain body 1964 relative to the fixation plate 822. The protrusions 1966 may
form a press fit with
a portion of the windows 824, but the drain body 1964 may be restrained
relative to the fixation
plate 822 in other ways. While the protrusions 1966 generally match the shape
of the windows 824
of the fixation plate 822, the protrusions 1966 and other features on the
drain body 1964 may be
configured to match the features of another fixation plate 822 in other
embodiments. For example,
contoured sections may be provided in the drain body 1964, or additional
protrusions may be
provided.
[00146] The drain body 1964 may be configured to be placed above a fixation
plate 822 (see
FIG. 8A) resting on a sternum 1856 (see FIG. 18A). Extension tubes 1970 may
connect to the
drain body 1964, and the extension tubes 1970 may extend around to the
opposite side of the
sternum 1856. The extension tubes 1970 may be wrapped through intercostal
spaces 1860 (see
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FIG. 18A) between adjacent ribs 1858 (see FIG. 18A) of the patient. The
extension tubes 1970
may collect excess fluid at locations behind the sternum 1856 where excess
fluids tend to collect,
and this excess fluid may flow through the extension tubes 1970 to an internal
cavity 1972 within
the drain body 1964. The drain body 1964 and the extension tubes 1970 may
comprise soft and
flexible material and may comprise an approved implant material such as
silicone.
[00147] Placement of the drain body 1964 above the fixation plate may be
beneficial for various
reasons. Placement of the drain body 1964 at this position may permit the
drain body 1964 to be
easily installed and easily removed. To the extent one desires to remove the
surgical drain assembly
1962, the drain body 1964 may be simply removed by gently prying the
protrusions 1966 free from
the fixation plate 822. This may effectively decouple the drain body 1964 and
the fixation plate
822. This removal of the drain body may be done using surgical instruments.
Once the drain body
1964 and the fixation plate 822 are decoupled, the surgical drain assembly
1962 may be removed
from the body of the patient by shifting the surgical drain assembly 1962
through a small incision
where the drainage tube 1968 exits though the skin. Notably. positioning of
the drain body 1964
above the sternum 1656 (see FIG. 16A) permits easy removal
________________________ if the drain body 1964 were
installed behind the sternum 1656, removal of the drain body 1964 is made more
difficult. To
remove a drain body 1964 installed behind the sternum 1656, one would need to
grasp the drain
body 1964 (which is positioned in a hard to reach location behind the sternum
1656), maneuver
the drain body 1964 through an intercostal space 1660 (see FIG. 16A) between
the ribs 1658 (see
FIG. 16A), and then maneuver the drain body 1964 to an incision in the skin of
the patient where
the drain body 1964 may be removed. Such an approach would be more difficult
and would
potentially require a larger incision to better enable one to remove the drain
body 1964.
Furthermore, installation and removal of a drain body 1964 at a position
behind the sternum 1656
may be problematic due to the presence of other organs located behind the
sternum 1656. By
placing the drain body 1964 above the sternum 1656, these issues may be
avoided, and smaller
extension tubes 1970 may be more easily wrapped around through the intercostal
spaces 1660 (see
FIG. 16A) to capture excess fluid from behind the sternum 1656.
[00148] Fluid may be retained in the internal cavity 1972 until it is removed
via a drainage tube
1968. This drainage tube 1968 may be provided at or proximate to the bottom of
the drain body
1964 when the drain body 1964 is in an upright position (e.g. when the patient
is standing up).
Thus, the force of gravity may urge fluids in the drain body 1964 to flow to
the drainage tube 1968
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where they may be removed. However, in some embodiments, multiple drainage
tubes 1968 may
be connected to the drain body 1964. Additionally, drainage tubes 1968 may be
provided at other
locations on the drain body 1964. In some embodiments, the drainage tube 1968
may extend to an
external environment from within the body of the patient, passing through
layers of flesh.
[00149] The force of gravity may be relied on exclusively in some embodiments
to urge fluids
to the drainage tube 1968. However, in other embodiments, a negative pressure
device may be
utilized to urge fluid to and through the drainage tube 1968. The negative
pressure device may also
tend to urge fluid through any openings 1976 (see FIG. 19E) in the drain body
1964, and the
negative pressure device may tend to urge fluid through the extension tubes
1970 so that fluid may
flow into the internal cavity 1972 and out of the drainage tube 1968. A
negative pressure device
(manually or mechanically actuated) can be attached to the free end of the
drainage tube 1968.
This negative pressure device may create suction throughout the surgical drain
assembly 1962 to
assist in the removal of excess fluid. In some embodiments, manually actuated
negative pressure
devices such as syringes or hand pumps may be used. Negative pressure does not
rely of gravity
feed to remove excess fluid, so the negative pressure device may permit excess
fluid removal while
the patient is resting, for example, in a supine position. However, the
negative pressure device may
be used in conjunction with gravitational forces to remove excess fluid in
some embodiments.
Alternatively, an inlet tube may be provided, and a positive pressure device
may be installed at the
inlet to urge excess fluid towards the drainage tube 1968 and out of the
surgical drain assembly
1962.
[00150] While the drain body 1964 of FIG. 19A includes protrusions 1966 to
assist in
restraining the drain body 1964 relative to a fixation plate, other approaches
for restraining these
two components are also contemplated. For example, FIG. 19D illustrates an
enhanced view of an
example drain body 1964 of a drainage assembly 1962 having suture holes 1974.
Suture holes
1974 may be provided on the drain body 1964 and the fixation plate, and the
drain body 1964 and
the fixation plate may be stitched together using the suture holes 1974.
Suture holes 1974 may be
provided generally parallel to the lateral edges of the fixation plate. A
surgical suture may extend
through the suture holes 1974 to bind the drain body 1964 and a fixation plate
822 (see FIG. 8A)
together, and the surgical suture may eventually be knotted and/or cut.
However, other fasteners
may be used. In some embodiments, multiple surgical sutures may be used to
provide increased
security. In some embodiments, the surgical sutures and suture holes 1974 may
be used instead of
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the protrusions 1966 to attach the drain body 1964 and fixation plate 822
together, but these
different approaches could be used simultaneously to provide further security
in some
embodiments. Additionally, in other embodiments, the fixation plate and the
drain body 1964 may
form one integral part.
[00151] Extension tubes may be used to provide obtain excess fluid, but the
drain body may
also include openings where fluid may flow through to enter the internal
cavity of the drain body.
FIG. 19E illustrates an enhanced view of an example drain body 1964 having a
plurality of
openings 1976 in the surface of the drain body 1964. Openings 1976 having
larger or smaller sizes
may be used in other embodiments. Furthermore, while the openings 1976 are
illustrated as having
a circular shape in FIG. 19E, the openings 1976 may have other shape in other
embodiments (e.g.
rectangular slits, oval shaped, asymmetrically shaped, etc.). Openings 1976
may be provided on
the top surface of the drain body 1964 so that fluid at the fixation plate may
flow through the
windows or other gaps to the openings 1976 so that the fluid may enter into
the internal cavity
1972. Additionally, openings 1976 may be provided on other surfaces of the
drain body 1964
and/or extension tubes 1970. Suction or other forces applied at an inlet tube
or a drainage tube may
tend to urge excess fluid through the openings and into the internal cavity of
the drain body 1964.
The openings 1976 may be positioned on the drain body 1964 to receive fluid
when a user is lying
down, but similar openings may be provided at other locations on the drain
body 1964 to receive
fluid when the user is standing up.
[00152] While the surgical drain assembly 1962 may be used primarily as a
drain in some
embodiments, it may additionally or alternatively be used to introduce
antiseptic and/or other
fluids to post-operatively flush the surgical site. In addition, medications
may be introduced to a
surgical site post-operatively using the surgical drain assembly 1962. For
example, an inlet tube
(see, e.g., 1969, FIG. 19G) may be provided where medications may be
introduced, and positive
pressure may be generated by gravity, a syringe, a hand pump, or some other
device to urge the
medications towards the surgical drain assembly and the surgical site.
Positive pressure for
introducing fluids may be generated by gravity feed such as an elevated IV bag
or via a syringe or
hand pump or a mechanical device. The introduced medication fluid may
eventually be removed
with the application of a negative pressure (manual or mechanical) device
applied at the drainage
tube 1968 or gravity feed. Additionally or alternatively, some or all of the
surgical drain assembly
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1962 (e.g. the surface of the drain body 1964) may be coated with
antimicrobial agents that release
into the surrounding in-vivo environment.
[00153] Looking now at FIGS. 19F-19G, another example embodiment of a drain
assembly 1962
is illustrated. FIG. 19F illustrates a bottom view of the drain assembly 1962,
and FIG. 19G illustrates
a top view of the drain assembly 1962. The drain assembly 1962 may include a
drain body 1964. The
drain body of FIGS. 19F-19G may generally match the shape of the sternum for a
patient. The drain
body 1964 may include one or more protrusions 1966 that extend downwardly from
the bottom surface
of the drain body 1964. The protrusions 1966 may be configured to engage with
a portion of the
windows 824 of the fixation plate 822 (see FIG. 8A) to restrict the movement
of the drain body
1964 relative to the fixation plate 822. The protrusions 1966 may form a press
fit with a portion of
the windows 824, but the drain body 1964 may be restrained relative to the
fixation plate 822 in
other ways. For example, protrusions may be provided on the drain body 1964
that are configured
to engage with the outer perimeter of the fixation plate 822. Additional
protrusions may be
provided on the bottom surface of the drain body 1964 that are configured to
engage with the
sternum itself, and these protrusions may extend at least partially into
intercostal spaces 1660 (see
FIG. 16A) between the ribs 1658 (see FIG. 16A) of the patient to assist in
positioning the drain
body 1964. Similar to the drain assembly of FIG. 19A, the drain assembly 1962
in FIGS. 19F and
19G may include extension tubes 1970. However, a drain assembly may be
provided without
extension tubes in some embodiments. The extension tubes 1970 may extend into
intercostal
spaces 1660 between the ribs 1658 of the patient so that the extension tubes
1970 reach the area
behind the sternum of the patient where excess fluid tends to collect. The
extension tubes 1970
may be pre-bent or curved at a pre-determined radius. This may help facilitate
maneuverability of
the bands 100 through and under the intercostal spaces 1660 and under the
posterior surface of the
sternum. The extension of extension tubes 1970 into the intercostal spaces
1660 may aid in the
positioning of the drain body 1964. The drain assembly 1962 may also include
an inlet tube 1969
and a drainage tube 1968.
[00154] While various embodiments described herein illustrate or describe the
use of the
fixation plate, bands, the tensioning device, and/or the drain assembly with a
severed sternum,
these components may be used with other bones in the human body, or these
components may be
used for bones of an animal. The fixation plate and bands described herein may
be formed from
any polymeric material known in the art. The polymeric material should
preferably have some
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rigidity and some flexibility. In an embodiment, the polymeric material used
to form the fixation
plate and/or the bands may comprise polyether ether ketone (PEEK). The
polymeric material may
be thermoformed. 3D printed, or formed using any other method known in the
art. Additionally,
the drain assembly may comprise a variety of materials. Drain assemblies may
comprise an elastic
material in some embodiments that may be easily conformed to the shape of the
sternum. For
example, the drain assembly may comprise a silicone, another soft rubber based
material, or a
polymeric material such as PEEK. The material in the drain assemblies may be
porous on some or
all sides so that excess fluid may enter into the drain assembly through the
material, and suction
may be applied to the drain assembly to urge excess fluid into the drain
assembly through the
porous material.
[00155] While various apparatuses and assemblies are provided, methods for
using these
apparatuses and assemblies are also contemplated. FIG. 20 illustrates an
example method for
installing a fixation plate and a drainage assembly to a severed sternum, in
accordance with some
embodiments discussed herein. At operation 2002, a tensioning gun, a fixation
plate, bands. and a
surgical drain assembly may be provided. In some embodiments, these components
may not be
provided. For example, where a user desires to install the fixation plate
without any surgical drain
assembly, the surgical drain assembly may be omitted.
[00156] At operation 2004, the fixation plate may be placed on the severed
sternum above the
cut. The fixation plate may be positioned on the sternum. The two severed
halves of the severed
sternum may need to have their positions adjusted before placement of the
fixation plate to ensure
proper healing.
[00157] At operations 2006-2010, bands may be applied and tensioned. At
operation 2006,
bands may be applied to the fixation plate. This may be done by placing a
portion of the bands
(e.g. the head) within windows of the fixation plate so that the movement of
the bands may be
restricted relative to the fixation plate. The end of the tail of a band may
be inserted into an internal
cavity at the head of the band so that a loop is formed. At operation 2008,
bands may be
provisionally tensioned. This provisional tensioning may be done by hand or
some other
instrument. Multiple bands may be applied and provisionally tensioned to
ensure that the fixation
plate and bands are positioned appropriately before performing any final
tensioning. At operation
2010, final tensioning may be applied to the bands. This final tensioning may
be performed using
the tensioning gun. The tensioning gun may be configured to apply tensioning
until the tension
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within the band reaches a tension limit, and the tensioning gun may cease
applying further tension
to the bands once this tension limit is reached. Alternatively, the tensioning
may continue being
applied at the same tension level proximate to the tension limit until the
bands are cut at operation
2012. At operation 2012, the bands may be cut. Where the tensioning gun is
used, the bands may
be cut automatically upon the desired tension level being reached within a
band. At operation 2014,
the drain body may be attached to the plate.
[00158] The operations of FIG. 20 may be performed in any order unless
otherwise noted. For
example, Furthermore, the operations of FIG. 20 may be performed
simultaneously in some
embodiments. For example, operations 2010 and 2012 may be performed
simultaneously where a
tensioning gun is used to simultaneously perform final tensioning and cutting,
and this may be
beneficial to increase the ease of installation as it reduces the number of
separate tasks that need
to be performed by the installer. Additionally, certain operations of FIG. 20
may be omitted or
certain operations may be added to FIG. 20. For example, provisional
tensioning may not be
performed, and the user may simply apply final tensioning at operation 2010.
CONCLUSION
[00159] Many modifications and other embodiments of the inventions set forth
herein will come
to mind to one skilled in the art to which these inventions pertain having the
benefit of the teachings
presented in the foregoing descriptions and the associated drawings.
Therefore, it is to be
understood that the embodiments of the invention are not to be limited to the
specific embodiments
disclosed and that modifications and other embodiments are intended to be
included within the
scope of the invention. Moreover, although the foregoing descriptions and the
associated drawings
describe example embodiments in the context of certain example combinations of
elements and/or
functions, it should be appreciated that different combinations of elements
and/or functions may
be provided by alternative embodiments without departing from the scope of the
invention. In this
regard, for example, different combinations of elements and/or functions than
those explicitly
described above are also contemplated within the scope of the invention.
Although specific terms
are employed herein, they are used in a generic and descriptive sense only and
not for purposes of
limitation.
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