U.S. patent application number 14/329429 was filed with the patent office on 2015-01-08 for compression brace.
The applicant listed for this patent is Wright Medical Technology, Inc.. Invention is credited to Robert M. Fencl, Vernon R. Hartdegen, Kevin Wong.
Application Number | 20150012004 14/329429 |
Document ID | / |
Family ID | 35515598 |
Filed Date | 2015-01-08 |
United States Patent
Application |
20150012004 |
Kind Code |
A1 |
Hartdegen; Vernon R. ; et
al. |
January 8, 2015 |
COMPRESSION BRACE
Abstract
A surgical device for pressing and retaining adjacent bones
against one another comprising a compression brace and separate
fasteners. The compression brace has at least two fastener
retaining portions. Each fastener retaining portion has a fastener
hole therethrough for receiving a fastener, such as a screw or pin.
A pair of bridge members are positioned between the fastener
retaining portions, and are spaced apart from one another to form a
compression opening. The compression bracket can include a
plurality of fastener retaining portions and a plurality of
compression openings. In some embodiments, the fasteners are
maintained in a substantially fixed relation with the fastener
retaining portion. The brace is installed on adjacent bones such
that a fastener engages each bone. The compression opening is
spread apart to draw the fasteners toward one another, and thereby
compress the adjacent bones together.
Inventors: |
Hartdegen; Vernon R.;
(Collierville, TN) ; Wong; Kevin; (Cordova,
TN) ; Fencl; Robert M.; (Cordova, TN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Wright Medical Technology, Inc. |
Memphis |
TN |
US |
|
|
Family ID: |
35515598 |
Appl. No.: |
14/329429 |
Filed: |
July 11, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14172547 |
Feb 4, 2014 |
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14329429 |
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12582210 |
Oct 20, 2009 |
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14172547 |
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10940396 |
Sep 14, 2004 |
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12582210 |
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Current U.S.
Class: |
606/105 |
Current CPC
Class: |
A61B 17/7059 20130101;
A61B 17/1728 20130101; A61B 17/8872 20130101; A61B 17/8014
20130101; A61B 17/86 20130101; A61B 17/66 20130101; A61B 2090/037
20160201; A61B 17/8085 20130101; A61B 17/8605 20130101; A61B
17/8875 20130101; A61B 17/1775 20161101; A61B 2017/681 20130101;
A61B 17/1782 20161101 |
Class at
Publication: |
606/105 |
International
Class: |
A61B 17/66 20060101
A61B017/66 |
Claims
1. A compression brace, comprising: a first fastener retainer
portion defining a first fastener opening; a second fastener
retainer portion defining a second fastener opening, wherein the
first and second fastener retainers are annular in shape; first and
second bridge members disposed between and coupled to the first and
second fastener retainer portions, wherein the bridge members are
spaced apart to define a compression opening therebetween, and
wherein the first and second bridge members are deformable to
adjust a distance between the first fastener retainer portion and
the second fastener retainer portion.
2. The compression brace of claim 1, wherein the first fastener
opening includes a locking feature configured to be coupled to a
first fastener received in the first fastener opening.
3. The compression brace of claim 2, wherein the locking feature
comprises a thread.
4. The compression brace of claim 2, wherein the second fastener
opening defines a non-locking opening sized and configured to
receive a second fastener received therein at an angle.
5. The compression brace of claim 4, wherein the first fastener
comprises a locking screw and the second fastener comprises a
non-locking screw.
6. The compression brace of claim 4, comprising a third fastener
retainer portion defining a third fastener opening coupled to the
first fastener retainer portion.
7. The compression brace of claim 6, wherein the third fastener
opening comprises a locking feature configured to be coupled to a
locking fastener received in the second fastener opening.
8. The compression brace of claim 7, comprising a fourth fastener
retainer portion defining a fourth fastener opening coupled to the
second fastener retainer portion.
9. The compression brace of claim 8, wherein the fourth fastener
opening defines a non-locking opening sized and configured to
receive a fastener received therein at an angle.
10. The compression brace of claim 9, wherein the first fastener
retainer portion, the second fastener retainer portion, the third
fastener retainer portion, and the fourth fastener retainer portion
are linearly arranged.
11. The compression brace of claim 2, wherein the first and second
bridge members define an arcuate compression opening.
12. A compression brace, comprising: at least two annular fastener
retainer portions each defining a respective fastener opening,
wherein at least one of the fastener openings comprises a
non-locking opening; first and second bridge members disposed
between and coupled to the first and second fastener retainer
portions, wherein the bridge members generally extend along a
longitudinal axis, wherein the bridge members are spaced apart to
define a compression opening, and wherein the bridge member are
deformable to contract the compression brace along the longitudinal
axis.
13. The compression brace of claim 12, wherein at least one of the
fastener openings comprises a locking feature configured to couple
to a first fastener received therein.
14. The compression brace of claim 13, wherein the locking feature
comprises a thread.
15. The compression brace of claim 13, wherein the non-locking
opening is sized and configured to provide selective angulation of
a second fastener received therein.
16. The compression brace of claim 15, wherein the first fastener
comprises a locking screw and the second fastener comprises a
non-locking screw
17. The compression brace of claim 15, wherein the at least two
annular fasteners are linearly arranged along the longitudinal
axis.
18. The compression brace of claim 12, wherein the compression
opening comprises an oblong opening in an un-deformed state.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 14/172,547, filed on Feb. 4, 2014, which is a
divisional of U.S. patent application Ser. No. 12/582,210, filed
Oct. 20, 2009, which is a continuation of U.S. patent application
Ser. No. 10/940,396, which was filed on Sep. 14, 2004, the
entireties of which are herein incorporated by reference.
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
[0002] Not applicable.
REFERENCE TO A MICROFICHE APPENDIX
[0003] Not applicable.
FIELD OF THE INVENTION
[0004] The present invention relates generally to orthopedic
surgery, and more particularly to devices and methods for reduction
of fractures and osteotomies by drawing bones together.
BACKGROUND OF THE INVENTION
[0005] U.S. Pat. No. 2,597,342 (Lang) discloses the use of a
compressible fastener for joining boards together. The Lang
fastener includes a central loop portion and claw members that
extend from diametrically opposed sides of the central loop. The
loop is preferably a parallelogram. Each claw member has two claws.
Each claw has downwardly turned ends with inwardly turned portions
which are configured to penetrate and engage boards. In operation,
the claw members are set astraddle adjacent board members. The
central loop is then expanded outward to draw the opposing arms
toward one another and thereby fasten the adjacent boards
together.
[0006] The earliest use of a compression opening in a surgical
application appears to be U.S. Pat. No. 4,887,601 (Richards).
Richards discloses an adjustable surgical staple having a slotted
spine and downwardly depending legs on opposing ends of the spine.
The legs are bent toward or away from the spine. However, a
straight leg embodiment is discussed with reference to FIGS. 7 and
8C. The Richards staple appears to have been intended for use in
ophthalmic surgery.
[0007] The use of a compressible bone staples for fracture
reduction is disclosed in U.S. Pat. No. 5,449,359 (Groiso); U.S.
Pat. No. 5,660,188 (Groiso); U.S. Pat. No. 5,853,414 (Groiso); U.S.
Pat. No. 5,947,999 (Groiso); and U.S. Pat. No. 5,993,476 (Groiso)
(collectively, "the Groiso patents"). However, the Groiso patents,
which are incorporated herein by reference, disclose the use of
staples having downwardly depending legs for engaging adjacent
bones. The Groiso compression bone staples suffer from several
drawbacks. Staples having opposing spaced-apart bridges can be
difficult and therefore expensive to manufacture. See e.g. U.S.
Pat. No. 5,947,999 (Col. 1, lines 48-52). Positioning holes in the
bones such that they align with the legs of the staple can be
challenging, and typically requires specialized instrumentation.
Additionally, staple legs tend to splay outward during use in vivo,
which may reduce the compressive force of the staple. Staples can
pull out of the bones. The configuration of staples also reduces
intra-operative choices. In order to accommodate varying inter-axis
and leg length requirements, it is necessary to provide a wide
array of staple sizes, which requires extra inventory. A staple
conventionally has legs of the same length and
diameter/cross-section, which may make the staple unsuitable for
situations in which it is desirable to have a longer or larger leg
on one side of the staple. Thus, even with a large inventory of
staple sizes, intra-operative choices may be limited.
[0008] One of the Groiso patents, U.S. Pat. No. 5,947,999,
discloses a compressible bone staple that has a pair of wing
members extending from opposing ends of the staple, each wing
member having apertures therein for receiving a screw for fastening
the clip member to a bio-organic tissue member. However, the '999
patent does not teach elimination of the downwardly depending leg
portions of the staple. In fact, Groiso teaches away from
elimination of the leg portions by noting "the aim of attaining a
desired spacing between bone fragments could be obtained with
connecting elements such as plates and screws, but these are much
bulkier, require major surgical procedures for the placing thereof
and the possibility of trauma is increased." U.S. Pat. No.
5,947,999 (Col. 2, lines 55-59). Additionally, the '999 patent is
direct toward connecting soft tissues (tendons and ligaments) to
bone.
[0009] U.S. Pat. No. 4,444,181 (Wevers et al.) discloses a bone
clip for repair of bones in vivo including a body having a slot in
a central portion thereof and a pair of downwardly depending legs
on either end of the body. After the clip is inserted in opposing
bones, opposing bridges are compressed toward one another (rather
than expanded) to shorten the clip and thereby draw the bones
together.
[0010] The use of bone screws and bone plates to reduce fractures
is well known in the art. However, as far as the applicant is
aware, no attempt has been made to provide a brace and screw
combination that has the ability to pull bone fragments together in
the efficient and highly effective manner described herein. There
is thus a need for a surgical device having the following
characteristics and advantages over the prior art.
OBJECTS AND SUMMARY OF THE INVENTION
[0011] It is an object of the invention to provide an improved
means of compressing adjacent bones together in surgical
applications.
[0012] It is an object of the invention to provide a substitute for
surgical compression staples that has superior anchorage in
bone.
[0013] It is an object of the invention to increase intra-operative
choices by allowing a surgeon to select desired lengths and
diameters of fasteners.
[0014] It is an object of the invention to reduce inventory by
allowing a surgeon to mix and match between braces and
fasteners.
[0015] The foregoing objects and advantages are achieved by
providing a surgical device for pressing and retaining adjacent
bones against one another comprising a compression brace and
separate fasteners. The compression brace has at least two fastener
retaining portions. Each fastener retaining portion has a fastener
hole therethrough for receiving a fastener. A pair of bridge
members are positioned between the fastener retaining portions, and
are spaced apart from one another to thereby form a compression
opening between the fastener retaining portions. Each bridge member
is preferably substantially V-shaped. The fasteners are sized and
configured to pass through the fastener hole and retain the
compression bracket on bones. The fasteners preferably have a
lengthwise shaft sized to pass through the fastener hole and an
upper retainer portion sized and configured to retain the fastener
in the fastener hole. In one embodiment, the fasteners are screws
having a lower thread positioned to engage bone. In an alternative
embodiment, the fasteners are pins. The compression bracket can
include a plurality of fastener retaining portions and a plurality
of compression openings.
[0016] The device is preferably provided with a means for
selectively locking the fasteners in the fastener holes to maintain
the fasteners in a substantially fixed relation with the fastener
retaining portion. Alternatively, the fastener hole of the brace
member may be substantially smooth. The shaft of at least one of
the fasteners can be sized to provide play between the shaft and
the fastener hole, such that the fastener can be selectively angled
into bone during use of the device.
[0017] The foregoing and other objects, features, aspects and
advantages of the invention will become more apparent from the
following detailed description of the invention when considered in
conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] FIG. 1 is a top view of one preferred embodiment of a
compression brace of the invention, showing the brace in an
uncompressed configuration.
[0019] FIG. 2 is a top view of the compression brace of FIG. 1,
showing the brace in a compressed configuration and featuring a
pair of screws disposed in the brace.
[0020] FIG. 3 is a side cross-section of view taken along 3-3 of
FIG. 1.
[0021] FIG. 4 is a side partial cross-section view illustrating use
of the compression brace of the invention to reduce a fracture by
drawing adjacent bones together, featuring the brace in an
uncompressed configuration prior to reduction of the fracture.
[0022] FIG. 5 is a side partial cross-section view illustrating use
of the compression brace of the invention to reduce a fracture by
drawing adjacent bones together, featuring the brace in a
compressed configuration.
[0023] FIG. 6 is a top view of a preferred embodiment of the
compression brace of the invention, featuring an unthreaded
fastener hole.
[0024] FIG. 7 is a side cross-section view taken along 7-7 of FIG.
6, and illustrating radial play of a screw within the unthreaded
fastener hole.
[0025] FIGS. 8A-8C show views of one preferred embodiment of the
invention, featuring a pair of compression brackets joined
end-to-end.
[0026] FIGS. 9A, 9B, and 9C provide isometric, top, and
cross-sectional views, respectively, of one preferred embodiment of
the invention, featuring a plurality of clip members radiating from
a shared fastener retaining portion.
[0027] FIGS. 10A, 10B, and 10C provide isometric, top, and side
views, respectively, of one preferred embodiment of the invention,
featuring a plurality of compression brackets joined end-to-end via
shared fastener retaining portions, and including a branching
compression bracket.
[0028] FIG. 11A is a side view of a preferred embodiment of a screw
type fastener for use in the invention.
[0029] FIG. 11B is an isometric view of the screw type fastener
illustrated in FIG. 11A in accordance with some embodiments.
[0030] FIG. 11C is a top side view of the screw type fastener
illustrated in FIG. 11A in accordance with some embodiments.
[0031] FIG. 12A is an isometric view of a pin-type fastener in
accordance with some embodiments.
[0032] FIG. 12B is a side perspective view of the pin-type fastener
illustrated in FIG. 12A in accordance with some embodiments.
[0033] FIG. 12C is a top side view of the pin-type fastener
illustrated in FIG. 12A.
[0034] FIGS. 13A, 13B, and 13C provide isometric, top, and side
views, respectively, of one preferred embodiment of the invention,
featuring a pair of compression brackets joined end-to-end via a
shared fastener retaining portion.
[0035] FIGS. 14A, 14B, and 14C provide isometric, top, and
cross-sectional views, respectively, of another example of a
compression brace and fasteners in accordance with some
embodiments.
[0036] FIGS. 15A, 15B, and 15C provide isometric, top, and
cross-sectional views, respectively, of another example of a
compression brace and fasteners in accordance with some
embodiments.
[0037] FIGS. 16A, 16B, and 16C provide isometric, top, and
cross-sectional views, respectively, of another example of a
compression brace and fasteners in accordance with some
embodiments.
[0038] FIGS. 17A, 17B, and 17C provide isometric, top, and
cross-sectional views, respectively, of another example of a
compression brace and fasteners in accordance with some
embodiments.
[0039] FIGS. 18A, 18B, and 18C provide isometric, top, and
cross-sectional views, respectively, of another example of a
compression brace and fasteners in accordance with some
embodiments.
[0040] FIGS. 19A, 19B, 19C, and 19D provide isometric, top,
cross-sectional, and side views, respectively, of another example
of a compression brace and fasteners in accordance with some
embodiments.
[0041] FIG. 20 is a perspective view of one embodiment of a drill
guide instrument for use in installing the compression brackets of
the invention.
[0042] FIGS. 21A and 21B provide perspective views of drivers for
use with the drill guide instrument of FIG. 20 in accordance with
some embodiments.
[0043] FIGS. 22A, 22B, 22C, and 22D provide isometric, side,
cross-sectional, and detail views, respectively, of a snap-off
screw for use with the compression brace in accordance with some
embodiments.
PREFERRED EMBODIMENTS OF THE INVENTION
[0044] In the following detailed description of the preferred
embodiments, reference is made to the accompanying drawings which
form a part hereof, and in which are shown by way of illustration
specific embodiments in which the invention may be practiced. It is
to be understood that other embodiments may be utilized and
structural changes may be made without departing from the scope of
the present invention.
[0045] As shown in FIGS. 4 and 5, the invention is a surgical
device for pressing and retaining adjacent bones 301, 302 against
one another, such as to reduce a fracture. As shown in the
uncompressed configuration of FIG. 4, the invention includes,
generally, a compression brace 1 and fasteners 100 for securing the
brace on bones 301, 302. As indicated in the compressed
configuration of FIG. 5, compression of the brace 1 presses the
adjacent bone fragments 301, 302 together.
[0046] As shown in FIG. 1, in a preferred embodiment the
compression brace 1 has at least two fastener retaining portions
10. Each fastener retaining portion 10 has a fastener hole or bore
20 therethrough for receiving a fastener 100. In a preferred
embodiment shown in FIG. 3, a thread 22 is provided in the fastener
hole 20. As indicated in the side view of FIG. 3, the brace 1 can
be considered to have a tissue or osteo side 2, which sits against
the bones during use, and an opposing side or outer surface 3. As
shown in FIG. 3, the fastener retaining portion 10 preferably has a
counterbore 30 formed in the outer surface 3. The counterbore 30 is
preferably substantially in axial alignment with the fastener hole
20. The counterbore 30 is preferably spherical. The counterbore 30
is sized and configured to provide countersinking of an upper
retainer portion 150 of a fastener 100 in the fastener retaining
portion 10 of the compression brace 1.
[0047] A pair of bridge members 50A, 50B are positioned between the
fastener retaining portions 10. The bridge members 50A, 50B
preferably extend directly from the fastener retaining portions 10,
but may be spaced from one or both of the fastener retaining
portions, such as by a shared extension portion disposed between
the bridge members 50A, 50B and fastener retainer portions 10. The
bridge members 50A, 50B are spaced apart from one another to form a
compression opening 70 between the fastener retaining portions 10.
The bridge members 50A, 50B and the compression opening 70 are used
to compress the fastener retaining portions 10 and fasteners 100
toward one another, in a manner described in further detail
below.
[0048] In the preferred embodiment shown in FIG. 1, the bridge
members 50A, 50B are substantially V-shaped. The V-shape is
preferably formed by generally linear portions 51, 52, which
normally join one another at an obtuse angle when the brace 10 is
in an uncompressed configuration. When opposing expansion forces
are applied to the bridges 50A, 50B substantially along lines of
force F in FIG. 1, central portions of the bridge members 50A, 50B
expand outward, thus drawing or compressing the fastener retaining
portions 10 toward one another. FIG. 2 demonstrates the
configuration of the compression brace of FIG. 1 after it has been
compressed a selected amount. Note that in FIG. 2, the compression
brace 1 has contracted generally along its lengthwise axis, while
the opposing bridge members 50A, 50B have expanded in directions
generally transverse to the lengthwise axis. Alternatively, the
bridge members 50A, 50B can be pinched toward one another. Pinching
will tend to force the fastener retaining portions 10 apart,
particularly when using a V-shaped opening, which can be useful for
certain surgical applications, such as distractions. In this
manner, the compression brace 1 can be used both for compression
and distraction, as well as to provide for fine-tuning of bone gap
sizes and compressive forces. Pinching can also be used to force
the fastener retaining portions 10 toward one another, resulting in
compression.
[0049] Bridge members 50A, 50B may alternatively have curved,
arcuate, straight, or other deformable configurations, provided
that bridges 50A, 50B are configured to form a deformable
compression opening 70. In FIG. 6, the bridge members 50A, 50B are
shortened and form a tighter angle along the compression opening
70. FIG. 6 also shows an embodiment in which a chamfer is formed
along the upper edge of the compression brace 1.
[0050] As shown in FIG. 4, fasteners 100 are used to secure the
bracket 1 to adjacent bones 301, 302. Each fastener 100 is sized
and configured to pass through a fastener hole 20 and to retain the
compression bracket 1 on bones 301, 302. Fasteners 100 of differing
diameter can be used. For example, if angulation of the fasterner
100 is desired, a smaller diameter may be used. The fasteners 100
may be locking or non-locking. In a preferred embodiment shown in
FIGS. 11A-11C, each fastener 100 has a lengthwise shaft 110 sized
to pass through at least one of the fastener holes 20, and an upper
retainer portion 150 sized and configured to retain the fastener
100 in the fastener hole 20. As shown in FIGS. 11A-11C, the
retainer portion 150 is preferably a circumferential head of the
type used in conventional screws. The head 150 is preferably
provided with a self-retaining drive mechanism, such as press-fit
drive slots 155.
[0051] As shown in FIGS. 11A-11C, the fastener 100 is preferably a
screw 100, in which case the shaft 110 is provided with a lower
thread 112 that is positioned to engage bone. The lower thread 112
is preferably self-tapping and self-drilling in bone. To facilitate
tapping of the lower thread 112 into bone, a cutting means 115 is
preferably provided on or adjacent the tip of the screw 100.
Cutting means are well known to those of skill in the art of
surgical screws.
[0052] As shown in FIGS. 12A-12C, an alternative preferred fastener
100 is a pin 100. The pin 100 shown in FIGS. 12A-12C has an
enlarged head or fastener retainer portion 150 configured to retain
the pin 100 in the fastener retainer member 10. The shaft 110 of
the pin 100 preferably has a substantially smooth outer
surface.
[0053] In a preferred embodiment shown in FIGS. 11A-11C, an upper
thread 120 is provided on the shaft 110 adjacent the head of the
fastener 100 for use in engaging the internal thread 22 in the
fastener hole 20. In a preferred embodiment, the upper thread 120
of the fastener 100 and the internal thread 22 of the compression
brace 1 serve to maintain the fastener 100 in a substantially fixed
relation to the fastener retaining portion 10. For example, in FIG.
5, an upper thread 120 has maintained the fasteners 100 in a
substantially perpendicular relation to the fastener retainer
portion 10. In the preferred embodiment of FIG. 5, the fasteners
100 have maintained a substantially fixed relation even after the
compression bracket 1 has been compressed to draw the bones 301,
302 together. A substantially fixed relationship can also be
obtained by providing a snug-fit screw head appropriately sized to
the fastener hole 20 and counterbore 30. In the prior art uni-body
compression staples disclosed in the Groiso patents, the pins of
the staples tend to splay outward significantly during use in vivo,
decreasing the compressive strength of the staples.
[0054] The invention may be provided with a means 130 for
selectively locking the fastener 100 in the fastener hole 20. In
the preferred embodiment shown in FIGS. 11A-11C, the locking means
130 is provided by forming the upper thread 120 from double-lead
threads 132, 133. The double-lead threads 132, 133 provide
selective locking of the fastener 100 in the fastener hole 20 via
locking interaction with the single internal thread 22 of the
fastener hole 20. One advantage of a double-lead type of locking
means 130 is that the threads can be configured such that the
compression bracket 1 can be reused, for example if it becomes
necessary to remove and replace or reposition the original fastener
100. Other locking means include mismatched threads.
[0055] As shown in FIG. 7, the surgical device may be configured
such that there is play between the fastener 100 and the fastener
retaining portion 10. In the preferred embodiment shown in FIG. 7,
the fastener hole 20 of the brace member is substantially smooth,
i.e. unthreaded. Additionally, the shaft 110 of the fastener 100 is
sized to provide play between the shaft 100 and the fastener hole
20. As indicated in FIG. 7, this configuration allows the fastener
100 to be selectively angled into bone during use of the
device.
[0056] Snap-off screws, such as the type shown in FIGS. 22A-22D,
can be used as fasteners 100. The snap-off surgical screw shown in
FIG. 22B is similar to the screws described above in that it has a
head 150, an upper threaded part 120 providing a locking thread 130
distal to the head, and a bore thread 112 distal to the locking
thread 130. Additionally, a shaft extension 160 extends above the
poly-axial head for use in rotating and driving the screw. The
shaft extension 160 is axially aligned with the screw 100. A distal
end of the shaft extension 160 is fixedly connected to the head 150
of the screw by a narrow shaft 161. After the screw 100 is
inserted, the shaft 160 is broken off of the screw 100 at the point
of the narrow shaft 161.
[0057] FIGS. 14A-17C provide views of various embodiments of
compression brackets 1 of the invention. The bracket shown in FIGS.
14A-14C has an elongated compression opening 70. FIGS. 15A-15C show
a compression bracket 1 having a spaced apart bridge members 50A,
50B, such that the opposing ends of the bridge members 50A, 50B are
not directly adjacent one another. FIGS. 16A-16C show a compression
bracket 1 having spaced apart bridge members 50A, 50B.
Additionally, the spaced apart bridge members 50A, 50B of FIGS.
16A-16C are straight, and thus lack the V-shaped configuration of
other embodiments. The configuration of FIGS. 16A-16C is
particularly adapted for situations in which it may be desirable to
obtain compression by bending the bridge members 50A, 50B toward
one another rather than by spreading the bridge members apart,
although the bridges 50A, 50B can also be spread. The bracket shown
in FIGS. 17A-17C has a straight and generally narrow compression
opening 70, but is provided with diametrically opposed distal
curved portions for use in engaging the bridge members 50A, 50B
during spreading of the compression opening 70.
[0058] FIGS. 18A-18C show yet another embodiment in which the
opposing bridge, and hence the compression opening 70, are
eliminated in favor of a single bridge 50. The single bridge 50 can
be bent in order to draw the opposing fastener retaining portions
10 together. Otherwise, the embodiment shown in FIGS. 18A-18C can
be provided with the various threaded and unthreaded variations
described above.
[0059] FIGS. 19A-19D show an embodiment that combines the features
of prior art surgical staples with the advantages provided by the
compression bracket 1 of the present invention. As shown in FIG.
19A, the combined staple-compression bracket includes opposing
bridge members 50A, 50B and a fastener retaining portion 10 having
the configuration and characteristics described above. However, the
opposing end of the device is provided with a downwardly depending
leg 200. The downwardly depending leg 200 is preferably provided
with means for securing the leg 200 in bone, such as the proximal
201 and distal 202 teeth or serrations shown in FIG. 19C.
[0060] As shown in FIGS. 8A-10C and 13A-13C, the compression
bracket 1 can include a plurality of fastener retaining portions 10
and a plurality of compression openings 70. In the embodiment shown
in FIGS. 8A-8C, a pair of compression brackets are joined
end-to-end in a unitary or unibody compression bracket structure.
FIGS. 13A-13C show an end-to-end configuration in which bridge
members 50A, 50B are joined by a shared fastener retaining portion
10. In FIGS. 9A-9C, a plurality of bridge members 50A, 50B radiate
from a shared fastener retaining portion 10. In FIGS. 10A-10C, a
plurality of compression brackets 1 are joined end-to-end via
shared fastener retaining portions 10. FIGS. 10A-10C also include a
compression bracket that branches off from the main chain via a
shared fastener retaining portion 10. Multi-part compression
brackets can also be configured to include adjacent compression
openings that are not separated by a fastener retaining member 20.
Multi-compression brackets such as those shown in FIGS. 8A-10C are
particularly suited for fixation or distraction of multi-part
fractures, such as when a bone fractures into more than two
fragments. The multi-compression bracket embodiments shown in FIGS.
8A-10C are merely exemplary preferred embodiments of the invention,
and are intended to provide those with skill in the art with the
building blocks necessary to configure a wide variety of
multi-compression bracket configurations, all of which would fall
within the scope of the invention.
[0061] One of the advantages of the invention over the prior art is
that it enables a surgeon to intra-operatively select various
combinations of brace and fastener sizes and configurations to
accommodate the operative condition of a particular surgical site,
thus providing greater options while decreasing staple inventory.
To further enhance options, compression braces 1 can be provided
with a combination of threaded and unthreaded holes. Such a
configuration could be used, for example, in situations where it is
desirable to provide a perpendicularly locked fastener on one end
of the brace 1, while providing selective angulation of the
fastener 100 on the opposing end of the brace. The same effect can
be obtained by selecting a fastener 100 sized to permit angulation
through a relatively larger threaded hole 20, such that the threads
of the hole 20 do not substantially impinge on the selected degree
of angulation. Similarly, a combination of locking and non-locking
threads can be used.
[0062] The compression brace 1 is used primarily for fixation of
arthrodeses and osteotomies. The compression brace 1 can also be
used in place of conventional plates, such as cuboid plates, hind
or mid-foot plates, or calcaneal plates.
[0063] In operation, the compression brace 1 is used as follows.
After preparation of the surgical site, the compression brace 1 is
placed on adjacent bones 301, 302 such that one of the fastener
holes is on the first bone or bone fragment 301 and one of the
fastener holes 302 is on the second bone or bone fragment (see FIG.
4). The first and second bones 301, 302 may of course be fragments
or segments of the same bone, i.e. after fracture. The compression
brace 1 is secured on the first bone 301 by inserting a fastener
100 through one of the fastener holes 20 and into the first bone
301. The compression brace 1 is secured to the second bone 302 by
inserting a fastener 100 through one of the fastener holes 20 and
into the second bone. The bridge members 50A, 50B of the
compression brace 1 are then spread apart to draw the fasteners 100
and the bones 301, 302 toward one another. During spreading of the
bridge members 50A, 50B during compression, sufficient force can be
applied to press adjacent bones 301, 302 against one another to
substantially eliminate a gap 300 between the bones 301, 302.
Alternatively, sufficient force can be applied to move the bones
301, 302 toward one another a selected distance, but without
removing the gap 300. With fractures having more than two bone
fragments, more than one compression brace 1 can be used to fix the
fracture. Alternatively, a multi-compression bracket such as the
embodiments shown in FIGS. 8A-10C can be used to fix the various
bone fragments. In one embodiment of the method, holes are drilled
into the bones 301, 302 through the fastener holes 20, and the
fasteners 100 are then installed in the drilled holes. Pre-drilling
is unnecessary if self-drilling fasteners 100 are used.
[0064] The compression bracket 1 can also be used as a distraction
plate, such as for opening osteotomies (e.g. HTO or spine
distraction). By applying a force to bridge members 50A, 50B, a
space can be created or widened, thus forcing the fasteners 100
apart. The device 1 can be used to open a space to allow insertion
of a spacer, and then used to close the space in order to sandwich
the spacer between adjacent bones.
[0065] The compression bracket 1 can be installed with or without
specialized instrumentation. FIG. 20 shows a preferred drill guide
instrument 300 for use in installing the compression braces 1. The
drill guide 300 includes a handle or mounting arm 310 having an
extension portion 312. A stationary guide base 318 is fixedly
mounted on an upper end of the extension portion 312. As shown in
FIG. 20, an adjustable guide base 328 is slidably and adjustably
engaged to the stationary guide base 318 via an adjustment member
320 having a lengthwise opening 321 therethrough. A locking means
312 is provided for selectively locking the adjustable guide base
328 relative to the stationary guide base 318. In the embodiment
shown in FIG. 20, the locking means is a ring 330 threaded on the
extension portion 312.
[0066] A first drill guide 301 is fixedly mounted on the stationary
guide base 318, while a second drill guide 302 is fixedly mounted
on the adjustable guide base 328. The drill guides 301, 302 are
preferably removable from the drill guide instrument in order to
accommodate selected sizes and configurations of fasteners 100 and
compression braces 1. A distal end of the drill guide 301, 302 is
provided with a counter bore having a side slot 304 therethrough
for accommodating a compression brace 1, in the manner shown in
FIG. 20.
[0067] As indicated in FIG. 20, each drill guide 301, 302 has a
lengthwise cylindrical sleeve (not shown) passing therethrough. As
shown in FIG. 20, the sleeves are sized to receive and provide
rotational guidance to driver components such as drill bit 380
(preferred embodiment shown in FIG. 21A) or a screwdriver 390
(preferred embodiment shown in FIG. 21B). As shown in FIGS. 21A and
21B, the driver components 380, 390 have a cylindrical shaft
portion 384 sized to permit guided rotation within the drill guides
301, 302. A stop 386 is provided on the shaft 384. The stop 386 is
sized and positioned to abut against the drill guide 301, 302, the
guide base 318, 328 or another selected portion of the drill guide
instrument 300 to prevent over drilling. The drive components 380,
390 are provided with a conventional 388 mount on an upper end for
selective engagement with a drive means, in a manner known to those
of skill in the art. As shown in FIG. 21A, the drill bit driver
component 380 is provided with a drill bit 381. As shown in FIG.
21B, the screw driver component 390 is provided with a screw driver
head 391 configured to match the fasteners 100. Various sizes and
types of drill bits 381 and screwdrivers 391 can be used with the
drill guide instrument 300, depending on intra-operative
conditions. A tamping driver (not shown) can be provided for
inserting pins 100 with the drill guide instrumentation 300.
[0068] As indicated in FIG. 20, the drill guide instrument 300 can
be adjusted to the size of a selected compression brace 1 simply by
sliding the second drill guide 302 relative to the first drill
guide 301 until a suitable position is reached, and then locking
the second drill guide 302 in place via the locking means 330. The
drill guide instrument 300 aligns the axes of the driver components
380, 390 with those of the fastener holes 20, which enables precise
drilling or threading of fastener screws 100.
[0069] Spreading of the bridge members 50A, 50B is preferably
accomplished using a spreader, such as the type shown in FIG. 10 of
U.S. Pat. No. 5,660,188 (Groiso). If crimping of the bridge members
50A, 50B is desired, pliers can be used.
[0070] The device and method can be used to join, fix and maintain
bones in various procedures, including: LisFranc arthrodesis; mono
or bi-cortical osteotomies in the forefoot; first
metatarsophalangeal arthrodesis; Akin osteotomy; midfoot and
hindfoot arthrodeses or osteotomies; fixation of osteotomies for
hallux valgus treatment (Scarf and Chevron); and arthrodeses of the
metatarsocuneiform joint to reposition and stabilize the metatarsus
primus varus; carpal bone fusion; wrist fusion; elbow fracture; and
metacarpal fractures.
[0071] The compression brace 1 and fasteners 100 are preferably
made of suitable biocompatible materials having sufficient
mechanical strength and elasticity for the desired applications of
the invention 1. Suitable materials include medical grade titanium
alloys, medical grade stainless steel, and cobalt chrome. A memory
metal, such as nitinol, can be incorporated into the invention.
Suitable non-metallic biocompatible materials can also be used.
Further, the brace 1 or fasteners 100 can be made of a suitable
bio-absorbable material, such that the components are eventually
absorbed by the body after healing of the bone parts.
[0072] Unless the context indicates otherwise, the term "bone" as
used herein includes whole bones as well as bone fragments (i.e.
the two or more fragments of a particular bone that remain after
the bone has been fractured, either completely or
incompletely).
[0073] Although the present invention has been described in terms
of specific embodiments, it is anticipated that alterations and
modifications thereof will no doubt become apparent to those
skilled in the art. It is therefore intended that the following
claims be interpreted as covering all alterations and modifications
that fall within the true spirit and scope of the invention.
* * * * *