U.S. patent application number 17/448273 was filed with the patent office on 2022-01-06 for implants, alignment guides, systems and methods of use.
This patent application is currently assigned to Paragon 28, Inc.. The applicant listed for this patent is Paragon 28, Inc.. Invention is credited to Randy ALLARD, Frank S. BONO, Laura Zagrocki BRINKER, Albert DACOSTA, Richard David HUNT, Spanky RAYMOND.
Application Number | 20220000525 17/448273 |
Document ID | / |
Family ID | |
Filed Date | 2022-01-06 |
United States Patent
Application |
20220000525 |
Kind Code |
A1 |
DACOSTA; Albert ; et
al. |
January 6, 2022 |
IMPLANTS, ALIGNMENT GUIDES, SYSTEMS AND METHODS OF USE
Abstract
Bone fusion system, devices, guide, implant and methods for
using the bone fusion system, devices, guide and implant are
disclosed. The fusion system includes an alignment guide and an
implant. The alignment guide couples to the implant. The alignment
guide includes a body, a fixation member engaging a first end of
the body, and a tissue protector engaging a second end of the body.
The implant includes a body portion, an extension portion extending
away from a first end of the body portion, a curved portion
extending away from a second end of the body portion, and a foot
member extending away from the curved portion perpendicular to the
body portion. Finally, methods for using the bone fusion system,
devices, guide and implant are disclosed.
Inventors: |
DACOSTA; Albert; (Lone Tree,
CO) ; BONO; Frank S.; (Castle Rock, CO) ;
ALLARD; Randy; (Golden, CO) ; HUNT; Richard
David; (Arvada, CO) ; RAYMOND; Spanky;
(Uniontown, OH) ; BRINKER; Laura Zagrocki; (Lone
Tree, CO) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Paragon 28, Inc. |
Englewood |
CO |
US |
|
|
Assignee: |
Paragon 28, Inc.
Englewood
CO
|
Appl. No.: |
17/448273 |
Filed: |
September 21, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16509160 |
Jul 11, 2019 |
11123120 |
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17448273 |
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PCT/US2019/041305 |
Jul 11, 2019 |
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16509160 |
|
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62696788 |
Jul 11, 2018 |
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62811980 |
Feb 28, 2019 |
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International
Class: |
A61B 17/80 20060101
A61B017/80; A61B 17/17 20060101 A61B017/17; A61B 17/86 20060101
A61B017/86; A61B 17/88 20060101 A61B017/88 |
Claims
1. A fusion system, comprising: an alignment guide system,
comprising: an alignment guide; and an implant, comprising: a body
portion; an extension portion extending away from a first end of
the body portion; a curved portion extending away from a second end
of the body portion; a foot member extending away from the curved
portion perpendicular to the body portion; and a fastener, wherein
the fastener engages the alignment guide system to position the
fastener relative to the body portion of the implant, wherein the
alignment guide system couples to the implant.
2. The fusion system of claim 1, wherein the alignment guide
comprises a body, with the body comprising: an arm extending from a
first end of the body to a second end of the body; an attachment
portion coupled to the arm at the first end of the body; a fixation
member engaging a first end of the body; a tissue protector
engaging a second end of the body; and a rotation member.
3. The fusion system of claim 2, wherein the rotation member
comprises a top surface and a bottom surface, wherein the top
surface of the rotation member engages a bottom surface of the
attachment portion, and wherein the fixation member couples the
rotation member to the attachment portion of the body.
4. The fusion system of claim 2, wherein the attachment portion
comprises: a through hole; an engagement protrusion extending away
from a bottom surface of the attachment portion; an opening
extending into the attachment portion from the bottom surface; a
first engagement surface positioned on the bottom surface of the
attachment portion between the opening and a side of the attachment
portion; and an alignment portion coupled to the arm at the second
end of the body.
5. The fusion system of claim 4, wherein the first engagement
surface comprises: a plurality of first protrusions; and a
plurality of first recesses, wherein the plurality of first
recesses alternate with the plurality of first protrusions.
6. The fusion system of claim 4, wherein the through hole of the
attachment portion extends from a top surface of the attachment
portion through to a bottom surface of the attachment portion.
7. The fusion system of claim 4, wherein the rotation member
comprises: a body; a through hole extending through the body,
wherein the engagement protrusion of the attachment portion is
received within the through hole of the rotation member; a stop pin
extending away from the top surface of the rotation member, wherein
the stop pin is positioned adjacent the through hole on the top
surface of the rotation member; and an alignment pin extending away
from the bottom surface of the rotation member, wherein the
alignment pin is positioned adjacent the through hole on the bottom
surface of the rotation member.
8. The fusion system of claim 7, wherein the top surface of the
rotation member comprises: a second engagement surface disposed
between the alignment pin and a side of the rotation member,
wherein the second engagement surface comprises: a plurality of
second protrusions; and a plurality of second recesses, wherein the
plurality of second recesses alternate with the plurality of second
protrusions.
9. The fusion system of claim 2, wherein the body portion of the
implant comprises: at least one first through hole; an engagement
opening for receiving a portion of the fixation member; and an
alignment opening spaced diagonally from the engagement opening,
wherein the alignment opening receives an alignment pin of the
rotation member.
10. The fusion system of claim 9, wherein the extension portion
comprises: at least one second through hole; and a compression slot
positioned near a first end of the implant, wherein the at least
one second through hole is positioned between the compression slot
and the body portion.
11. The fusion system of claim 10, wherein the curved portion
comprises: at least one third through hole extending through the
implant at an angle relative to a top surface of the implant.
12. The fusion system of claim 11, wherein the foot member
comprises: at least one fourth through hole extending through the
implant perpendicular to the top surface of the implant.
13. The fusion system of claim 1, wherein the extension portion has
a width that is lesser than that of the body portion.
14. The fusion system of claim 13, wherein the width of the
extension portion is lesser than a width of the foot member.
15. An implant, comprising: a body portion; an extension portion
extending away from a first end of the body portion; a curved
portion extending away from a second end of the body portion; a
foot member extending away from the curved portion perpendicular to
the body portion, wherein the extension portion has a width that is
lesser than that of the body portion and the foot member; and a
fastener, wherein the fastener engages an alignment guide system to
position the fastener relative to the body portion of the implant,
wherein the alignment guide system couples to the implant.
16. The implant of claim 15, wherein the body portion of the
implant comprises: at least one first through hole; an engagement
opening for receiving a portion of a fixation member; and an
alignment opening spaced diagonally from the engagement
opening.
17. The implant of claim 15, wherein the extension portion
comprises: at least one second through hole; and a compression slot
positioned near a first end of the implant, wherein the at least
one second through hole is positioned between the compression slot
and the body portion.
18. The implant of claim 15, wherein the curved portion of the
implant comprises: at least one third through hole extending
through the implant at an angle relative to a top surface of the
implant; and wherein the foot member of the implant comprises: at
least one fourth through hole extending through the implant
perpendicular to the top surface of the implant.
19. The implant of claim 15, wherein the foot member is angled
relative to the body portion at a substantially oblique angle.
20. The implant of claim 15, wherein a top surface of the foot
member comprises a substantially convex geometry and a bottom
surface of the foot member comprises a substantially concave
geometry.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. application Ser.
No. 16/509,160 filed on Jul. 11, 2019, entitled Implants, Alignment
Guides, Systems and Methods of Use, which issues as U.S. Pat. No.
11,123,120 on Sep. 21, 2021, which is a continuation of PCT
Application No. PCT/US2019/041305 filed on Jul. 11, 2019, entitled
Implants, Alignment Guides, Systems and Methods of Use, which
claims benefit to U.S. provisional application No. 62/696,788 filed
Jul. 11, 2018, entitled Implant, Alignment Guide, System and
Methods of Use, and U.S. provisional application No. 62/811,980
filed Feb. 28, 2019, entitled Implants, Alignment Guides, Systems
and Methods of Use, which are incorporated herein by reference in
their entireties.
FIELD OF INVENTION
[0002] The present disclosure relates generally to general surgery
and orthopaedic implants used for achieving bone fusion. More
specifically, but not exclusively, the present disclosure relates
to surgical devices, implants, guides, and systems for fixation of
human bones, such as, the foot and ankle bones, and to stabilize
the realignment of a fracture, dislocation, fusion or the like of
the bones of the foot and ankle.
BACKGROUND OF THE INVENTION
[0003] Currently available guides and systems for foot and ankle
fusion surgeries include fixed trajectories for insertion of
fasteners to fuse the patient's bones. The currently available
guides and systems limit a surgeon's options and do not allow for
adjustment based on each patient's unique anatomy.
[0004] Accordingly, it is an object of the present disclosure to
overcome one or more of the above-described drawbacks and/or
disadvantages of the currently used procedures. For example, in
view of the deficiencies of the currently available implants,
guides, systems and methods it would be desirable to develop
implants, guides, systems and methods that allow for adjustment of
the fastener insertion trajectories to overcome the above-noted
drawbacks of the currently available systems and surgical
solutions.
SUMMARY OF THE INVENTION
[0005] Aspects of the present disclosure provide bone fixation
devices for use in a method of fusing bones. Specifically, the
present disclosure relates to surgical devices, implants, guides,
systems and methods for fixation of human bones, such as, the foot
and ankle bones, and to stabilize realignment of a fracture,
dislocation, fusion or the like of the foot or ankle bones.
[0006] In one aspect, provided herein is a fusion system, including
an alignment guide and an implant, wherein the alignment guide
couples to the implant.
[0007] In another aspect, provided herein is an alignment guide,
including a body, a fixation member engaging a first end of the
body, and a tissue protector engaging a second end of the body.
[0008] In yet another aspect, provided herein is an implant,
including a body portion, an extension portion extending away from
a first end of the body portion, a curved portion extending away
from a second end of the body portion, and a foot member extending
away from the curved portion perpendicular to the body portion.
[0009] In a further aspect, provided herein is a method for using a
fusion system, including preparing at least one joint and inserting
fixation wires across the at least one joint. The method may also
include obtaining a plate and placing the plate over a first bone
and second bone of the at least one joint. The method further
includes coupling the plate to the first bone and the second bone
and obtaining an alignment guide. In addition, the method includes
coupling the alignment guide to the plate and rotating the
alignment guide to a desired angle of insertion for a compression
fastener. The method also includes securing the alignment guide at
the desired angle of insertion and inserting a k-wire through the
alignment guide and across the at least one joint. The method
further includes removing the alignment guide from the plate and
inserting the compression fastener through the first bone and
second bone. Finally, the method includes removing the k-wire and
closing an incision.
[0010] These, and other objects, features and advantages of this
disclosure will become apparent from the following detailed
description of the various aspects of the disclosure taken in
conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] The accompanying drawings, which are incorporated in and
constitute a part of the specification, illustrate embodiments of
the disclosure and together with the detailed description herein,
serve to explain the principles of the disclosure. The drawings are
only for purposes of illustrating preferred embodiments and are not
to be construed as limiting the disclosure. It is emphasized that,
in accordance with the standard practice in the industry, various
features are not drawn to scale. In fact, the dimensions of the
various features may be arbitrarily increased or reduced for
clarity of discussion. The foregoing and other objects, features
and advantages of the disclosure are apparent from the following
detailed description taken in conjunction with the accompanying
drawings in which:
[0012] FIG. 1 is a first perspective view of a fusion system, in
accordance with an aspect of the present disclosure;
[0013] FIG. 2 is a second perspective view of the fusion system of
FIG. 1, in accordance with an aspect of the present disclosure;
[0014] FIG. 3 is a top perspective view of a plate of the fusion
system of FIG. 1, in accordance with an aspect of the present
disclosure;
[0015] FIG. 4 is a bottom perspective view of the plate of FIG. 3,
in accordance with an aspect of the present disclosure;
[0016] FIG. 5 is a top view of the plate of FIG. 3, in accordance
with an aspect of the present disclosure;
[0017] FIG. 6 is a bottom view of the plate of FIG. 3, in
accordance with an aspect of the present disclosure;
[0018] FIG. 7 is a first end view of the plate of FIG. 3, in
accordance with an aspect of the present disclosure;
[0019] FIG. 8 is a second end view of the plate of FIG. 3, in
accordance with an aspect of the present disclosure;
[0020] FIG. 9 is a first side view of the plate of FIG. 3, in
accordance with an aspect of the present disclosure;
[0021] FIG. 10 is a second side view of the plate of FIG. 3, in
accordance with an aspect of the present disclosure;
[0022] FIG. 11 is a perspective view of an alignment guide of the
fusion system of FIG. 1, in accordance with an aspect of the
present disclosure;
[0023] FIG. 12 is a side view of the alignment guide of FIG. 11, in
accordance with an aspect of the present disclosure;
[0024] FIG. 13 is a first end perspective view of the alignment
guide of FIG. 11, in accordance with an aspect of the present
disclosure;
[0025] FIG. 14 is a second end perspective view of the alignment
guide of FIG. 11, in accordance with an aspect of the present
disclosure;
[0026] FIG. 15 is a top view of the alignment guide of FIG. 11, in
accordance with an aspect of the present disclosure;
[0027] FIG. 16 is a bottom view of the alignment guide of FIG. 11,
in accordance with an aspect of the present disclosure;
[0028] FIG. 17 is a partially exploded, bottom perspective view of
the alignment guide of FIG. 11, in accordance with an aspect of the
present disclosure;
[0029] FIG. 18 is a partially exploded, top perspective view of the
alignment guide of FIG. 11, in accordance with an aspect of the
present disclosure;
[0030] FIG. 19 is an exploded, first perspective view of the
alignment guide of FIG. 11, in accordance with an aspect of the
present disclosure;
[0031] FIG. 20 is an exploded, second perspective view of the
alignment guide of FIG. 11, in accordance with an aspect of the
present disclosure;
[0032] FIG. 21 is an exploded, third perspective view of the
alignment guide of FIG. 11, in accordance with an aspect of the
present disclosure;
[0033] FIG. 22 is an exploded, side view of the alignment guide of
FIG. 11, in accordance with an aspect of the present
disclosure;
[0034] FIG. 23 is an anterior view of a portion of a patient's leg
and foot with a compression system coupled to the bones, in
accordance with an aspect of the present disclosure;
[0035] FIG. 24 is an anterior view of the bones of FIG. 23 with the
plate of FIG. 3 positioned over a joint and temporarily secured to
the patient's bones, in accordance with an aspect of the present
disclosure;
[0036] FIG. 25 is an anterior view of the bones of FIG. 24 with one
temporary fixator replaced by a drill guide coupled to the plate of
FIG. 3 and a drill inserted through the drill guide and into at
least one bone, in accordance with an aspect of the present
disclosure;
[0037] FIG. 26 is an anterior view of the bones of FIG. 25 after
removal of the drill and drill guide and with a screw driver
inserting a first screw through the plate of FIG. 3 and into at
least one bone, in accordance with an aspect of the present
disclosure;
[0038] FIG. 27 is an anterior view of the bones of FIG. 26 after
insertion of a second screw through the plate of FIG. 3 and into at
least one bone, in accordance with an aspect of the present
disclosure;
[0039] FIG. 28 is an anterior view of the bones of FIG. 27 after
coupling a compression slot drill guide to the slot of the plate of
FIG. 3 and inserting a drill through the compression slot drill
guide and into at least one bone, in accordance with an aspect of
the present disclosure;
[0040] FIG. 29 is a perspective view of the bones of FIG. 28 after
removal of the drill and compression slot drill guide and insertion
of a compression screw and five additional screws through the plate
of FIG. 3 and into at least one bone, in accordance with an aspect
of the present disclosure;
[0041] FIG. 30 is an enlarged, anterior view of the bones of FIG.
29 with a screw replaced by a plate washer and a fastener of the
fusion system of FIG. 1 inserted across a joint, in accordance with
an aspect of the present disclosure;
[0042] FIG. 31 is a perspective view of the bones of FIG. 29 after
the alignment guide of FIG. 11 is coupled to the plate of FIG. 3
and a guide wire is inserted through the alignment guide and across
the patient's joint, in accordance with an aspect of the present
disclosure;
[0043] FIG. 32 is a perspective view of the bones of FIG. 31 as the
alignment guide of FIG. 11 is being removed from the plate and
guide wire, in accordance with an aspect of the present
disclosure;
[0044] FIG. 33 is a perspective view of the bones of FIG. 32 during
insertion of a fastener of the fusion system of FIG. 1 over the
guide wire using a cannulated screw driver, in accordance with an
aspect of the present disclosure;
[0045] FIG. 34 is a side view of the bones of FIG. 33 after
insertion of the fastener and removal of the screw driver and guide
wire, in accordance with an aspect of the present disclosure;
[0046] FIG. 35 is an exploded, first perspective view of another
fusion system, in accordance with an aspect of the present
disclosure;
[0047] FIG. 36 is another exploded, perspective view of the fusion
system of FIG. 35, in accordance with an aspect of the present
disclosure;
[0048] FIG. 37 is a top partially exploded perspective view of the
fusion system of FIG. 35, in accordance with an aspect of the
present disclosure;
[0049] FIG. 38 is a bottom partially exploded perspective view of
the fusion system of FIG. 35, in accordance with an aspect of the
present disclosure;
[0050] FIG. 39 is a first side, perspective view of the alignment
guide of the fusion system of FIG. 1, in accordance with an aspect
of the present disclosure;
[0051] FIG. 40 is a first side view of the alignment guide of FIG.
39, in accordance with an aspect of the present disclosure;
[0052] FIG. 41 is a second side, perspective view of the alignment
guide of FIG. 39, in accordance with an aspect of the present
disclosure;
[0053] FIG. 42 is a first end, perspective view of the alignment
guide of FIG. 39, in accordance with an aspect of the present
disclosure;
[0054] FIG. 43 is a top view of the alignment guide of FIG. 39, in
accordance with an aspect of the present disclosure;
[0055] FIG. 44 is a bottom view of the alignment guide of FIG. 39,
in accordance with an aspect of the present disclosure;
[0056] FIG. 45 is a partially exploded, bottom perspective view of
the alignment guide of FIG. 39, in accordance with an aspect of the
present disclosure;
[0057] FIG. 46 is a partially exploded, top perspective view of the
alignment guide of FIG. 39, in accordance with an aspect of the
present disclosure;
[0058] FIG. 47 is an exploded, top perspective view of the
alignment guide of FIG. 39, in accordance with an aspect of the
present disclosure;
[0059] FIG. 48 is an exploded, bottom perspective view of the
alignment guide of FIG. 39, in accordance with an aspect of the
present disclosure;
[0060] FIG. 49 is an exploded, first end perspective view of the
alignment guide of FIG. 39, in accordance with an aspect of the
present disclosure;
[0061] FIG. 50 is a side view of the alignment guide of FIG. 39, in
accordance with an aspect of the present disclosure;
[0062] FIG. 51 is a perspective view of the bones of FIG. 29 after
the alignment guide of FIG. 35 is coupled to the plate of FIG. 3,
in accordance with an aspect of the present disclosure;
[0063] and
[0064] FIG. 52 is a perspective view of the bones of FIG. 51 as the
alignment guide of FIG. 35 is being removed from the plate and
guide wire, in accordance with an aspect of the present
disclosure.
DETAILED DESCRIPTION OF THE INVENTION
[0065] Generally stated, disclosed herein are embodiments of
devices, implants, guides, and systems for fixation of human bones,
such as, foot and ankle bones. Further, surgical methods for using
the devices, implants, guides, and systems for fixation of human
bones to stabilize realignment of a fracture, dislocation, fusion
or the like of the foot and ankle bones are discussed.
[0066] In this detailed description and the following claims, the
words proximal, distal, anterior or plantar, posterior or dorsal,
medial, lateral, superior and inferior are defined by their
standard usage for indicating a particular part of a bone, implant,
device or guide according to the relative disposition of the
natural bone or directional terms of reference. For example,
"proximal" means the portion of a device or implant nearest the
torso, while "distal" indicates the portion of the device or
implant farthest from the torso. As for directional terms,
"anterior" is a direction towards the front side of the body,
"posterior" means a direction towards the back side of the body,
"medial" means towards the midline of the body, "lateral" is a
direction towards the sides or away from the midline of the body,
"superior" means a direction above and "inferior" means a direction
below another object or structure. Further, specifically in regards
to the foot, the term "dorsal" refers to the top of the foot and
the term "plantar" refers the bottom of the foot.
[0067] Similarly, positions or directions may be used herein with
reference to anatomical structures or surfaces. For example, as the
current devices and methods are described herein with reference to
use with the bones of the foot and ankle, the bones of the foot,
ankle and lower leg may be used to describe the surfaces,
positions, directions or orientations of the devices,
instrumentation and methods. Further, the devices and methods, and
the aspects, components, features and the like thereof, disclosed
herein are described with respect to one side of the body for
brevity purposes. However, as the human body is relatively
symmetrical or mirrored about a line of symmetry (midline), it is
hereby expressly contemplated that the devices and methods, and the
aspects, components, features and the like thereof, described
and/or illustrated herein may be changed, varied, modified,
reconfigured or otherwise altered for use or association with
another side of the body for a same or similar purpose without
departing from the spirit and scope of the disclosure. For example,
the devices and methods, and the aspects, components, features and
the like thereof, described herein with respect to the right foot
and ankle may be mirrored so that they likewise function with the
left foot and ankle. Further, the devices and methods, and the
aspects, components, features and the like thereof, disclosed
herein are described with respect to the foot and ankle for brevity
purposes, but it should be understood that the devices and methods
may be used with other bones of the body having similar structures,
for example the upper extremity, and more specifically, with the
bones of the wrist, hand, and arm.
[0068] Referring to the drawings, wherein like reference numerals
are used to indicate like or analogous components throughout the
several views, and with particular reference to FIGS. 1 and 2,
there is illustrated a fusion system or ankle fusion plate system
100. The fusion system 100 may include an implant, plate or bone
plate 110, an alignment guide 200, and a fastener 160. The
alignment guide 200 may be coupled to the plate 110 for insertion
of the fastener 160 across a joint without contacting the fasteners
or screws (not shown) inserted through the plate 110. Each
component of the fusion system 100 may be made from, for example, a
biocompatible material, including but not limited to a metal,
polymer, composite, etc.
[0069] Referring now to FIGS. 3-10, the implant or plate 110 is
shown. The plate 110 includes a top surface 112 opposite a bottom
surface 114, a first end 116 opposite a second end 118, and a first
side 120 generally opposite a second side 122. The plate 110 also
includes a body portion or intermediate portion 124, an extension
portion or proximal portion 126 extending from the proximal end of
the body portion 124 to the first end 116, and a foot member or
distal portion 128 extending from the distal end of the body
portion 124 at the second end 118. At least a portion of the foot
member 128 may extend away from the body portion 124, for example,
generally perpendicular to the top surface 112 of the body portion
124. The plate 110 may further include a transition portion or
connecting portion 130 positioned between the body portion 124 and
the foot member 128. The transition portion 130 may be, for
example, a curved portion positioning the body portion 124
generally perpendicular to the foot member 128, as shown in FIGS. 9
and 10. The foot member 128 may be angled with respect to the body
portion 124 and in an embodiment the angle may, for example, range
from approximately 80.degree. to 120.degree., and more specifically
may be approximately 100.degree..
[0070] With continued reference to FIGS. 3-10 and more specifically
FIGS. 5 and 6, the body portion 124 may include at least one lobe
132, 134, for example, a first lobe 132 and a second lobe 134. The
first lobe 132 may, for example, extend at least partially away
from the first side 120 of the plate 110. The second lobe 134 may,
for example, extend at least partially away from the second side
122 of the plate 110. Each lobe 132, 134 may include a first
through hole or fastener hole 136 extending through the plate 110
from a top surface 112 to a bottom surface 114. The first through
hole 136 extending through the first lobe 132 may be positioned,
for example, lateral to a midline of the plate 110. The first
through hole 136 extending through the second lobe 134 may be
positioned, for example, medial to the midline of the plate 110.
The first through holes 136 may be, for example, positioned in the
body portion 124 to allow for the fastener 160 to pass between
screws inserted into through holes 136 without contacting the
screws. The body portion 124 may also include a first opening or
engagement opening 138 and a second opening or alignment opening
140 for coupling to the alignment guide 200. The first opening 138
may be, for example, offset from the second opening 140 along a
longitudinal axis of the plate 110. The first opening 138 may also
be positioned near the first side 120 of the plate 110 and between
the first side 120 and the second opening 140. The second opening
140 may be positioned near the second side 122 of the plate 110 and
between the second side 122 and the first opening 138. A line
connecting the first opening 138 and second opening 140 may form an
angle with respect to a midline of the plate 110 and the angle may
be, for example, approximately 24.degree. to 34.degree. and more
specifically approximately 29.degree.. This angle also defines the
angle between the midline of the plate 110 and the longitudinal
axis of the arm 212 of the alignment guide 210, as described in
greater detail below. The body portion 124 of the plate may also
be, for example, angled between the extension portion 126 or
proximal end and the second lobe 134 on the second side 122 of the
plate 110. The angled portion of the second side 122 may also be,
for example, curved along the angle, as shown in FIGS. 5 and 6. In
addition, the second side 122 may be, for example, curved between
the second lobe 134 and the transition portion 130. Further, the
first side 120 may be, for example, curved between the first lobe
132 and the transition portion 130. Also, as shown in FIGS. 9 and
10, the body portion 124 may be, for example, curved as the body
portion 124 extends between the extension portion 126 and the
transition portion 130.
[0071] As shown in FIGS. 3-6, the extension portion 126 of the
plate 110 may include at least one second through hole or fastener
hole 142 positioned along the extension portion 126. The extension
portion 126 may also include a slot, compression slot, or opening
144. The slot 144 may be positioned, for example, at or near the
first end 116 of the plate 110. The slot 144 may be, for example,
longer than the through holes 136, 142. The at least one second
through hole 142 may be positioned, for example, between the slot
144 and the body portion 124. The at least one second through hole
142 and the slot 144 may be, for example, positioned along the
midline of the plate 110. The extension portion 126 may have, for
example, a width that is smaller than the width of the body portion
124 and the foot member 128.
[0072] Referring now to FIGS. 3, 4, 7 and 8, the foot member 128
may include at least one third lobe or distal lobe 146. As
depicted, the foot member 128 includes two distal lobes 146. Each
lobe 146 includes a third through hole or fastener hole 148 for
receiving a fastener or bone screw to secure the plate to a
patient's foot. The through holes 148 may extend through the plate
110 perpendicular to the direction that the through holes 136, 142
extend through the plate 110. The through hole 148 positioned near
the first side 120 of the plate 110 may be, for example, positioned
along the midline of the plate 110, while the through hole 148
positioned near the second side 122 of the plate 110 may be, for
example, positioned medial to the midline. The foot member 128 may
also include, for example, a ramped portion 152 positioned between
the two lobes 146 to allow for surrounding tissue to slide over the
distal end 118 of the plate 110 without irritating the tissue. The
connecting portion 130 may also include at least one fourth through
hole or fastener hole 150 extending through the plate 110, as shown
in FIGS. 3, 4, 7, and 8. As shown, the connecting portion 130 may
include, for example, two through holes 150. The through holes 150
may, for example, extend through the curved section of the
connecting portion 130 positioning the through holes 150 at an
angle relative to both the through holes 136, 142 and the through
holes 148. The through hole 150 positioned near the first side 120
of the plate 110 may be, for example, positioned along the midline
of the plate 110, while the through hole 150 positioned near the
second side 122 of the plate 110 may be, for example, positioned
medial to the midline
[0073] Referring now to FIGS. 1 and 2, the fastener 160 may be, for
example, a compression screw, compression fastener, beam fastener,
bone screw, beam screw, fixator, elongate member, rod, lag screw,
headless screw, a solid screw, or screw for crossing a joint or
fracture. The fastener or screw 160 may include a head portion 162
and a shaft or shank portion 164 extending away from a bottom
surface of the head portion 162. The fastener 160 may also include
a cannulation or through hole 166 extending from a first end
through the head portion 162 and the shaft portion 164 to the
second end. The cannulation 166 may be, for example, sized and
shaped to receive a temporary fixation or guiding member, such as,
a k-wire, guide wire, olive wire, pin, or the like, as known by one
of ordinary skill in the art, as described in greater detail below
with reference to FIGS. 32 and 33. As shown in FIG. 2, the head
portion 162 may include, for example, a drive feature 174 for
receiving a drill or screw driver to insert the fastener 160 into a
patient's bones. The shaft portion 164 of the fastener 160 may
include, for example, a threaded portion 168 and a smooth portion
170 along the length of the shaft portion 164. The length of the
threaded portion 168 and smooth portion 170 may, for example, vary
depending on the bones the fastener 160 will be inserted into, in
the depicted embodiment the threaded portion 168 is longer than the
smooth portion 170. The shaft portion 164 may also include at least
one tooth 172 positioned at the end of the shaft portion 164 to
assist with insertion of the fastener 160 into a patient's
bones.
[0074] Referring now to FIGS. 11-22, the alignment guide or bone
plate alignment guide 200 is shown. The alignment guide 200 may
include a body 210, a fixation member or coupling member 250, and a
guide pin tissue protector 270. The fixation member 250 may be
received in a first end of the body 210 and the guide pin tissue
protector 270 may be received in a second end of the body 210. The
alignment guide 200 may also include at least one guide wire or pin
(not shown) for insertion through the guide pin tissue protector
270.
[0075] As shown in FIGS. 19-22, the body 210 may include an arm 212
with an attachment portion 214 at the first end of the body 210 and
an alignment portion 240 at the second end of the body 210. The
attachment portion 214 may include a through hole 216 extending
through the arm 212 near the first end. The through hole 216 may
also extend through a coupling protrusion or engagement protrusion
218 extending away from a bottom surface of the attachment portion
214. The attachment portion 214 may also include an opening or stop
opening 220 extending into the attachment portion 214 of the arm
212 from the bottom surface, as shown in FIGS. 20 and 21. The
opening 220 may be positioned adjacent to the engagement protrusion
218. With continued reference to FIGS. 20 and 21, the attachment
portion 214 also includes a first engagement surface 222 with, for
example, alternating protrusions and recesses. The protrusions of
the first engagement surface 222 may be, for example, spaced apart
to form recesses between the protrusions. The protrusions of the
first engagement surface 222 may be, for example, male teeth. The
protrusions of the first engagement surface 222 may also be, for
example, positioned with the interior ends of the protrusions
positioned closer together than the exterior ends of the
protrusions to form a curved or arced shape. Each protrusion of the
first engagement surface 222 may be spaced apart, for example, to
allow for approximately 2.5.degree. of rotation from a central axis
of the arm 212. In one embodiment, the protrusions allow for, for
example, a maximum of approximately 5.degree. of rotation in each
direction from the central axis to provide a total of approximately
10.degree. of rotation. The first engagement surface 222 may be,
for example, positioned adjacent to the opening 220 on a side of
the bottom surface of the attachment portion 214 and opposite the
through hole 218.
[0076] With continued reference to FIGS. 19-22, the alignment guide
200 may also include a rotation member 224. The rotation member 224
may engage the bottom surface of the attachment portion 214 of the
body 210. The rotation member 224 may include a body 226 with a
through hole 228 extending through the body 226 from a top surface
236 to a bottom surface 238. The through hole 228 may be, for
example, sized and shaped to receive the engagement protrusion 218.
The rotation member 224 may also include a stop peg, stop pin or
stop protrusion 230 extending away from the top surface 236 of the
body 226, as shown in FIGS. 19, 21 and 22. The stop pin 230 may be,
for example, sized and shaped to be inserted into the opening 220
on the bottom surface of the attachment portion 214. The shapes of
the opening 220 and stop pin 230 prevent the alignment guide 210
from being over-rotated with respect to the plate 110. For example,
the opening 220 and stop pin 230 may allow for approximately
10.degree. of rotation relative to a center line drawn between the
first opening 138 and the second opening 140 on the plate 110. The
top surface 236 of the body 226 of the rotation member 224 may also
include a second engagement surface 232 with, for example,
alternating protrusions and recesses. The protrusions of the second
engagement surface 232 may be, for example, spaced apart to form
recesses between the protrusions. The recesses of the second
engagement surface 232 may be, for example, female teeth. The
protrusions of the second engagement surface 232 may also be, for
example, positioned with the interior ends of the protrusions
positioned closer together than the exterior ends of the
protrusions to form a curved or arced shape. Each recess of the
second engagement surface 232 may be spaced apart, for example, to
allow for approximately 2.5.degree. of rotation from a central axis
of the arm 212. In one embodiment, the recesses allow for, for
example, a maximum of approximately 5.degree. of rotation in each
direction from the central axis to provide a total of approximately
10.degree. of rotation. The rotation member 224 may further include
a second peg or alignment pin 234 extending away from the bottom
surface 238 of the body 226, as shown in FIGS. 20-22. The second
alignment pin 234 may be positioned adjacent to the through hole
228. The second alignment pin 234 may be, for example, sized and
shaped to engage the alignment opening 140 of the plate 110. The
bottom surface 238 of the rotation member 224 may be, for example,
curved, arced, or otherwise shaped to match the shape of a top
surface of the plate 110 where the rotation member 224 engages the
plate 110.
[0077] The alignment portion 240 may include at least one hole 242,
as shown in FIGS. 1, 2, 13, 14, and 19-21. The alignment portion
240 may include, for example, three holes 242, as shown in the
depicted embodiment. The three holes 242 may be positioned linearly
as the alignment portion 240 extends away from the arm 212. The
holes 242 may be, for example, straight or angled to a desired
insertion position as the holes 242 extend through the arm 212 of
the body 210. In the depicted embodiment, the holes 242 extend
through the alignment portion 240 parallel to each other. The holes
242 may be, for example, sized and shaped to receive the guide pin
tissue protector 270.
[0078] As shown in FIGS. 1, 2 and 19-22, the fixation member 250
may include a knob 252 and a shaft 254 extending away from a bottom
surface of the knob 252. The shaft 254 may include a first portion
256 extending away from the knob 252 and a second portion 258
extending away from the first portion 256. The first portion 256
may have, for example, a diameter larger than the diameter of the
second portion 258. The shaft 254 may also include at least one
engagement member 260, 262 for coupling to the engagement opening
138 of the plate 110. The at least one engagement member 260, 262
may include a first engagement member 260 and a second engagement
member 262. The first engagement member 260 may be, for example,
positioned at an end of the second portion 258 opposite the first
portion 256. The second engagement member 262 may extend away from
the first engagement member 260 on a side opposite the second
portion 258. The first engagement member 260 may have, for example,
a first diameter and the second engagement member 262 may have, for
example, a second diameter. The first diameter may be, for example,
larger than the second diameter. The first and second engagement
members 260, 262 may be, for example, threaded to engage
corresponding threads in the opening 138 of the plate 110 as shown
in the depicted embodiment, deformable to be removeably press fit
into the opening 138 in the plate 110, or another similar
configuration that achieves a coupling of the alignment guide 200
to the plate 110.
[0079] As shown in FIGS. 1, 2, 11-14, and 16-22, the guide pin
tissue protector 270 may include a handle portion 272 and a shaft
portion 274 extending away from the handle portion 272. The handle
portion 272 may be coupled to the first end of the shaft portion
274 and a tip 276 may be positioned at the second end of the shaft
portion 274. The shaft portion 274 may taper at the second end to
form the tip 276. The guide pin tissue protector 270 may also
include a through hole or cannulation 278 extending from the first
end to the second end to enable a guide wire (not shown) to pass
through the tissue protector 270 and engage a patient's bone.
[0080] Referring now to FIGS. 35-52, another ankle fusion plate
system 400 is shown. The fusion system 400 may include an implant,
plate or bone plate 110, an alignment guide 410, and a fastener
450. The alignment guide 410 may be coupled to the plate 110 for
insertion of the fastener 450 across a joint without contacting the
fasteners or screws (not shown) inserted through the plate 110. The
plate 110 is as described above with reference to FIGS. 3-10 and
will not be described again here for brevity sake. Each component
of the fusion system 400 may be made from, for example, a
biocompatible material, including but not limited to a metal,
polymer, composite, etc.
[0081] Referring now to FIGS. 35-38, the fastener 450 may be, for
example, a compression screw, compression fastener, beam fastener,
bone screw, beam screw, fixator, elongate member, rod, lag screw,
headless screw, a solid screw, or screw for crossing a joint or
fracture. The fastener or screw 450 may include a head portion 452
and a shaft or shank portion 454 extending away from a bottom
surface of the head portion 452. The fastener 450 may also include
a cannulation or through hole 456 extending from a first end
through the head portion 452 and the shaft portion 454 to the
second end. The cannulation 456 may be, for example, sized and
shaped to receive a temporary fixation or guiding member, such as,
a k-wire, guide wire, olive wire, pin, or the like, as known by one
of ordinary skill in the art. As shown in FIGS. 36 and 38, the head
portion 452 may include, for example, a drive feature 464 for
receiving a drill or screw driver to insert the fastener 450 into a
patient's bones. The shaft portion 454 of the fastener 450 may
include, for example, a threaded portion 458 and a smooth portion
460 along the length of the shaft portion 454. The length of the
threaded portion 458 and smooth portion 460 may, for example, vary
depending on the bones the fastener 450 will be inserted into. In
the depicted embodiment, the threaded portion 458 is shorter than
the smooth portion 460. Alternatively, the shaft portion 454 may
be, for example, threaded along its entire length. The shaft
portion 454 may also include at least one tooth 462 positioned at
the end of the shaft portion 454 to assist with insertion of the
fastener 450 into a patient's bones.
[0082] Referring now to FIGS. 39-50, the alignment guide or bone
plate alignment guide 410 is shown. The alignment guide 410 may
include a body 412, a fixation member 430, a coupling member 440,
and a guide pin tissue protector 270. The fixation member 430 and
coupling member 440 may be received in a first end of the body 412
and the guide pin tissue protector 270 may be received in a second
end of the body 412. The alignment guide 410 may also include at
least one guide wire or pin (not shown) for insertion through the
guide pin tissue protector 270.
[0083] As shown in FIGS. 47-50, the body 412 may include an arm 414
with an attachment portion 416 at the first end of the body 412 and
an alignment portion 422 at the second end of the body 412. The
attachment portion 416 may include a through hole 418 extending
through the attachment portion 416 near the first end. The
attachment portion 416 may also include a peg or alignment pin 420
extending away from a bottom surface of the attachment portion 416.
The through hole 418 may be positioned adjacent to the alignment
pin 420. The alignment pin 420 may be, for example, sized and
shaped to engage the alignment opening 140 of the plate 110. The
bottom surface of the attachment portion 416 may be, for example, a
flat surface for engaging the coupling member 440.
[0084] The alignment portion 422 may include at least one hole 424,
as shown in FIGS. 35-39, 41, 42, and 47-49. The alignment portion
422 may include at least one hole 424. The at least one hole 424
may be, for example, three holes 424, as shown in the depicted
embodiment. The three holes 424 may be positioned linearly as the
alignment portion 422 extends away from the arm 414. The holes 424
may be, for example, straight or angled to a desired insertion
position as the holes 424 extend through the arm 414 of the body
412. In the depicted embodiment, the holes 424 extend through the
alignment portion 422 parallel to each other. The holes 424 may be,
for example, sized and shaped to receive the shaft portion 274 of
the guide pin tissue protector 270.
[0085] As shown in FIGS. 35, 36 and 47-50, the fixation member 430
may include a knob 432 and a shaft 434 extending away from a bottom
surface of the knob 432. The shaft 434 may include a first portion
436 extending away from the knob 432 and at least one engagement
member 438 for coupling to the engagement opening 138 of the plate
110. The at least one engagement member 438 may be, for example,
positioned at an end of the first portion 436 opposite the knob
432. The engagement member 438 may be, for example, threaded to
engage corresponding threads in the opening 138 of the plate 110 as
shown in the depicted embodiment, deformable to be removeably press
fit into the opening 138 in the plate 110, or another similar
configuration that achieves a coupling of the alignment guide 410
to the plate 110.
[0086] With continued reference to FIGS. 35, 36 and 47-50, the
coupling member 440 includes a shaft 442 and a head 444 positioned
at a first end of the coupling member 440. The head 444 may have,
for example, an outer diameter that is larger than the outer
diameter of the shaft 442. A bottom surface of the head portion 444
of the coupling member 440 may be, for example, curved, arced, or
otherwise shaped to match the shape of a top surface of the plate
110 where the head portion 444 engages the plate 110. The coupling
member 440 may also include a through hole 446 extending through
the coupling member 440 along the longitudinal axis. As shown in
FIGS. 36, 38, 41, 44, and 45, the coupling member 440 may also
include a recessed region 448 extending into the head 444 from the
first end. The exterior diameter of the shaft 442 of the coupling
member 440 corresponds to the interior diameter of the through hole
418 of the alignment guide 410. Further, the exterior diameter of
the first portion 436 of the fixation member 430 may correspond to
the interior diameter of the through hole 418 of the alignment
guide 410 allowing for the shaft 434 of the alignment guide 410 to
pass through the through hole 446 of the coupling member 440. In
addition, the exterior diameter of the head 444 of the coupling
member 440 may have, for example, a diameter larger than the
diameter of the through hole 418 of the alignment guide 410.
[0087] Referring now to FIGS. 23-34, one embodiment of a surgical
method of using the fusion system 100, 400 is shown. The method may
include exposing a joint 308 and preparing the joint 308. Exposing
the joint 308 may include making an incision, for example, a
longitudinal midline incision over the anterior ankle, beginning
approximately 10 cm proximal to the ankle joint 308 and terminating
just distal to the talonavicular joint 300. The incision may start
approximately 1 cm lateral to the tibial crest just lateral to the
tibialis anterior tendon. Exposing the joint 308 may include, for
example, making an initial incision through the skin only. Next,
the superficial peroneal nerve should be identified and retracted
laterally. The surgeon should then continue to expose the joint 308
to the extensor retinaculum. Once the extensor retinaculum is
exposed, the extensor hallucis longus (EHL) tendon may be
identified below the retinaculum and the retinaculum should be
divided longitudinally over the extensor hallucis longus tendon,
which leaving the sheath of the tibialis anterior (TA) tendon
intact. Then, the EHL tendon may be retracted laterally and the TA
tendon medially. In addition, exposing the joint 308 may include
continuing exposure until the anterior capsule is visualized. Next,
an anterior capsulotomy via a longitudinal incision may be
performed and the capsule and periosteum may be elevated over the
anterior tibia 306 and talus 302 to expose the anterior ankle
joint, the tibial plafond, the medial and lateral gutters and the
anterior and dorsal talus. Next, any osteophytes on the tibia 306
and talus 302 may be removed to allow for exposure to the ankle
joint and facilitate entry of instrumentation for cartilage
removal. The method may then include joint preparation, for
example, of the tibiotalar joint 308 based on surgeon preference,
as known by one of ordinary skill in the art.
[0088] As shown in FIG. 23, the method may then optionally include
temporarily fixing the ankle joint 308. The joint 308 may be fixed
by placing k-wires or other fasteners across the joint 308.
Alternatively, a wire 310 may be placed bi-cortically across the
tibia 306. A second wire 310 may be placed bi-cortically across the
talus 302. Then, a first compressor 312 may be slid onto two wires
310 from a medial side. Then, a second compressor 314 may be slid
onto the two wires 310 from a lateral side. A force may be applied
to each side of the compressors 312, 314 until adequate compression
is achieved across the tibiotalar joint 308 and varus/valgus
orientation is correct. Next, k-wires (not shown) may be placed
across the tibiotalar joint 308 to maintain the position and
compression, if necessary. Alternatively, two wires 310 may be
placed unicortically into the tibia 306, medially and laterally,
respectively. The two wires 310 may be placed unicortically into
the talus 302, medially and laterally, respectively. The first
compressor 312 may be slid onto the two medial wires 310 and the
second compressor 314 may be slid onto the lateral wires 310. The
compression of the tibiotalar joint 308 may be achieved as
described above.
[0089] Referring now to FIG. 24, the method may then include
obtaining a fusion plate 110. The proximal aspect of the plate 110
may be centered over the tibia 306 and the distal portion of the
plate 110 will be located slightly medial to midline. Next, the
method may include securing the plate 110 to the anterior aspect of
the tibiotalar joint 308 using a temporary fixator 316, for
example, a long olive wire in the tibia and temporary fixators 318,
for example, short olive wires in the distal holes of the talus
302. After the plate 110 is temporarily secured to the bones 302,
306, the position of the plate 110 may be confirmed using
fluoroscopy.
[0090] Referring now to FIG. 25, the method may also include
preparing the talus 302 for inserting screws 326, 328 (See FIGS.
27-29 and 31-34) through the fourth through holes 150 in the plate
110. As shown in FIG. 26, the method may include obtaining a drill
guide 320 and inserting the drill guide 320 into a fourth through
hole 150 positioned on the lateral side. Next, a drill 322 may be
inserted through the drill guide 320 and into the talus 302. After
drilling an opening in the talus 302, the drill 322 and drill guide
320 may be removed from the lateral through hole 150 and a depth
gauge (not shown) may be inserted into the drilled opening to
measure the screw length for insertion into the drilled opening.
Once the screw length is determined, a first screw 326 may be
inserted through the lateral through hole 150 and into the talus
302 using, for example, a screw driver 324. The first screw 326 may
be, for example, partially inserted into the lateral hole 150 until
the second screw 328 is inserted into the medial hole 150. As shown
in FIG. 27, the method may include inserting the second screw 328
through the medial hole 150 in the plate 110 and into the talus
302, as described above with respect to the insertion of the first
screw 326. Once the first and second screws 326, 328 are both
partially inserted through the plate 110, the screws 326, 328 may
then be fully tightened and seated to secure the plate 110 to the
talus 302.
[0091] Referring now to FIG. 28, the method may also include
obtaining a compression slot drill guide 330 and inserting the
drill guide 330 into the slot 144 of the plate 110 on the tibia
306. The drill guide 330 may include, for example, an arrow which
may point toward the tibiotalar joint 308. Next, a drill 332 may be
inserted through the drill guide 330 and an opening may be drilled
into the tibia 306. The method may further include removing the
drill guide 330 from the plate 110 and measuring the drilled
opening with a depth gauge to determine the screw length for the
compression screw 334. The compression screw 334 may then be
inserted through the slot 144 until fully seated, as shown in FIG.
29. Next, the remaining holes 136, 142 may be prepared as described
in greater detail above to receive screws 336, 338, 340 for
insertion into the tibia 306. Then, the two compressors 312, 314
and wires 310 may be removed from the bones 302, 306. The method
may further include inserting screws 342, 344 through the third
through holes 148 of the plate 110 and into the talus 302 using the
method described in greater detail above, which will not be
described again here for brevity sake.
[0092] Referring now to FIG. 30, the method may optionally include
inserting a plate washer or washer 346 in place of at least one
screw 326, 328, 336, 338, 340, 342, 344. The plate washers may be
used if the talus is flattened or there are inconsistencies in the
tibia. As shown in FIG. 30, a washer 346 may be inserted into the
medial through hole 150 in place of the second screw 328. If a
washer 346 is used, the washer 346 should be completely tightened
to fully seat and lock the washer 346 within the screw hole
150.
[0093] As shown in FIG. 31, the method may also include inserting a
fastener 160 across the joint 308. With respect to the fastener
160, the terms "fastener," "crossing screw," "bone screw,"
"fixator," and "screw" may be used interchangeably herein as they
essentially describe the same type of device. Inserting the
crossing screw 160 may include obtaining an alignment guide 200 and
coupling the alignment guide 200 to the plate 110. Alternatively,
it is also contemplated that the alignment guide 200 may be coupled
to the plate 110 prior to temporarily fixing the plate 110 to the
bones 302, 306 to allow for use of a partially threaded screw to be
placed prior to plate fixation to achieve compression across the
joint via a partially threaded screw. After coupling the alignment
guide 200 to the plate 110, the method may include inserting the
guide pin tissue protector 270 through the desired hole 242 in the
alignment portion 240 of the body 210. The body 210 may then be
rotated with respect to the rotation member 224 coupled to the
plate 110 to adjust the angle and start point of the fastener 160.
Once the desired angle and start point of the fastener 160 is
established, the fixation member 250 may be tightened to set and
lock the position of the body 210 relative to the rotation member
224.
[0094] In another embodiment, as shown in FIGS. 51-52, the method
may also include inserting a fastener 450 across the joint 308.
With respect to the fastener 450, the terms "fastener," "crossing
screw," "bone screw," "fixator," and "screw" may be used
interchangeably herein as they essentially describe the same type
of device. Inserting the crossing screw 450 may include obtaining
an alignment guide 410 and coupling the alignment guide 410 to the
plate 110. Alternatively, it is also contemplated that the
alignment guide 410 may be coupled to the plate 110 prior to
temporarily fixing the plate 110 to the bones 302, 306 to allow for
use of a partially threaded screw to be placed prior to plate
fixation to achieve compression across the joint via a partially
threaded screw. After coupling the alignment guide 410 to the plate
110, the method may include inserting the guide pin tissue
protector 270 through the desired hole 424 in the alignment portion
422 of the body 412.
[0095] The methods may then include inserting a wire 348 through
the tissue protector 270 and across the arthrodesis site in the
bones 302, 306. After inserting the wire 348 across the joint 308,
the method may include confirming the position and length of the
wire 348 using fluoroscopy.
[0096] Referring now to FIG. 32, once the position and length of
the wire 348 is confirmed, the alignment guide 200, 410 may be
removed from the plate 110. The alignment guide 200, 410 may be
removed by detaching the fixation member 250, 430 from the plate
110 and sliding the tissue protector 270 and body 210, 412 off of
the guide wire 348. As shown in FIG. 33, the method may then
include measuring the length of the fastener 160 using a depth
gauge (not shown). Next, the method includes drilling over the
guide wire 348 using a drill (not shown) and inserting the fastener
160, 450 over the wire 348 and into the bones 302, 306. As shown in
FIG. 34, the method may also include confirming the screw length
and placement of the screws using fluoroscopy. If the screw length
and placement is correct, then the guide wire 348 may be removed.
Finally, the method may include performing incision closure or
concomitant procedures.
[0097] As may be recognized by those of ordinary skill in the art
based on the teachings herein, numerous changes and modifications
may be made to the above-described and other embodiments of the
present disclosure without departing from the scope of the
disclosure. The components of the fusion system as disclosed in the
specification, including the accompanying abstract and drawings,
may be replaced by alternative component(s) or feature(s), such as
those disclosed in another embodiment, which serve the same,
equivalent or similar purpose as known by those skilled in the art
to achieve the same, equivalent or similar results by such
alternative component(s) or feature(s) to provide a similar
function for the intended purpose. In addition, the fusion system
may include more or fewer components or features than the
embodiments as described and illustrated herein. Accordingly, this
detailed description of the currently-preferred embodiments is to
be taken in an illustrative, as opposed to limiting of the
disclosure.
[0098] The terminology used herein is for the purpose of describing
particular embodiments only and is not intended to be limiting of
the disclosure. As used herein, the singular forms "a", "an" and
"the" are intended to include the plural forms as well, unless the
context clearly indicates otherwise. It will be further understood
that the terms "comprise" (and any form of comprise, such as
"comprises" and "comprising"), "have" (and any form of have, such
as "has", and "having"), "include" (and any form of include, such
as "includes" and "including"), and "contain" (and any form of
contain, such as "contains" and "containing") are open-ended
linking verbs. As a result, a method or device that "comprises,"
"has," "includes," or "contains" one or more steps or elements
possesses those one or more steps or elements, but is not limited
to possessing only those one or more steps or elements. Likewise, a
step of a method or an element of a device that "comprises," "has,"
"includes," or "contains" one or more features possesses those one
or more features, but is not limited to possessing only those one
or more features. Furthermore, a device or structure that is
configured in a certain way is configured in at least that way, but
may also be configured in ways that are not listed.
[0099] The disclosure has been described with reference to the
preferred embodiments. It will be understood that the architectural
and operational embodiments described herein are exemplary of a
plurality of possible arrangements to provide the same general
features, characteristics, and general system operation.
Modifications and alterations will occur to others upon a reading
and understanding of the preceding detailed description. It is
intended that the disclosure be construed as including all such
modifications and alterations.
* * * * *