U.S. patent application number 10/940396 was filed with the patent office on 2006-03-16 for compression brace.
Invention is credited to Robert M. Fencl, Vernon R. Hartdegen, Kevin Wong.
Application Number | 20060058796 10/940396 |
Document ID | / |
Family ID | 35515598 |
Filed Date | 2006-03-16 |
United States Patent
Application |
20060058796 |
Kind Code |
A1 |
Hartdegen; Vernon R. ; et
al. |
March 16, 2006 |
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) |
Correspondence
Address: |
WRIGHT MEDICAL TECHNOLOGY, INC.
5677 AIRLINE ROAD
ARLINGTON
TN
38002-9501
US
|
Family ID: |
35515598 |
Appl. No.: |
10/940396 |
Filed: |
September 14, 2004 |
Current U.S.
Class: |
606/281 ;
606/282; 606/291 |
Current CPC
Class: |
A61B 17/8872 20130101;
A61B 17/1775 20161101; A61B 17/8014 20130101; A61B 17/8085
20130101; A61B 17/1782 20161101; A61B 2017/681 20130101; A61B
17/8875 20130101; A61B 17/1728 20130101; A61B 17/8605 20130101;
A61B 17/86 20130101; A61B 17/66 20130101; A61B 2090/037 20160201;
A61B 17/7059 20130101 |
Class at
Publication: |
606/069 |
International
Class: |
A61F 2/30 20060101
A61F002/30 |
Claims
1-15. (canceled)
16. A surgical device for pressing and retaining adjacent bones
against one another, such as to reduce a fracture, comprising: a
compression brace, said compression brace having at least two
fastener retaining portions, each said fastener retaining portion
having a fastener hole therethrough for receiving a fastener, said
fastener hole having an internal thread, a pair of bridge members
positioned between said fastener retaining portions, said bridge
members spaced apart from one another to thereby form a compression
opening between said fastener retaining portions, and at least two
fasteners, each said fastener having a lengthwise shaft sized to
pass through said fastener hole and a head portion sized and
configured to retain said fastener in said fastener hole, an upper
thread on said shaft adjacent said head of said fastener for
engaging said internal thread in said fastener hole to thereby
maintain said fastener in a substantially fixed relation to said
fastener retaining portion.
17. The device of claim 16, wherein said substantially fixed
relation between said fastener and said fastener retaining portion
is substantially perpendicular.
18. The device of claim 16, wherein said upper thread comprises
double lead threads, said double-lead threads providing selective
locking of said fastener in said fastener hole
19. The device of claim 16, wherein at least one of said fasteners
is a screw, said shaft of said screw having a lower thread
positioned to engage bone.
20. The device of claim 19, wherein said lower thread is
self-drilling in bone.
21. The device of claim 20, further comprising a cutting means
along said tip of said screw for facilitating initial engagement of
bone by said lower thread.
22. The device of claim 16, wherein at least one of said fasteners
is a pin.
23. The device of claim 16, further comprising each said fastener
retaining portion having a counterbore formed in an upper surface
thereof, said counterbore substantially in axial alignment with
said fastener hole, said counterbore sized and configured to
provide countersinking of said upper retainer portion of said
fastener in said fastener retaining portion.
24. The device of claim 16, wherein each said bridge member is
substantially V-shaped.
25. The device of claim 16, wherein said compression brace includes
a plurality of fastener retaining portions and a plurality of
compression openings.
26. A method of compressing and retaining first and second adjacent
bones together, such as to reduce a fracture, comprising: providing
a compression brace, said compression brace having at least two
fastener retaining portions, each said fastener retaining portion
having a fastener hole therethrough for receiving a fastener, said
fastener hole having an internal thread, a pair of bridge members
positioned between said fastener retaining portions, said bridge
members spaced apart from one another to thereby form a compression
opening between said fastener retaining portions; providing at
least two fasteners, each said fastener having a lengthwise shaft
sized to pass fastener hole, and an upper thread on said shaft
adjacent said head of said fastener for engaging said internal
thread in said fastener hole to thereby maintain said fastener in a
substantially fixed relation to said fastener retaining portion;
placing the compression brace on the bones such that one of said
fastener holes is on the first bone and one of said fastener holes
is on the second bone; securing the compression brace on the first
bone by threading one of said fasteners into one of said fastener
holes and into the first bone; securing the compression brace on
the second bone by threading one of said fasteners into a second
one of said fastener holes and into the second bone; and spreading
the bridge members of the compression brace apart to thereby draw
said fasteners and said bones toward one another.
27. The method of claim 1, further comprising, prior to said step
of securing the compression bracket on the bones, forming a hole in
each of the bones for receiving the fasteners.
28. The method of claim 1, wherein said bridge members are spread
until said bones contact one another.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] Not applicable
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
8. 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-C show views of one preferred embodiment of the
invention, featuring a pair of compression brackets joined
end-to-end.
[0026] FIG. 9 provides views of one preferred embodiment of the
invention, featuring a plurality of clip members radiating from a
shared fastener retaining portion.
[0027] FIG. 10 provides views 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. 11 is a side view of a preferred embodiment of a screw
type fastener for use in the invention.
[0029] FIG. 12 is a side perspective view of a preferred embodiment
of a pin-type fastener for use in the invention.
[0030] FIG. 13 provides views of one preferred embodiment of the
invention, featuring a pair of compression brackets joined
end-to-end via a shared fastener retaining portion.
[0031] FIG. 14 provides views of one preferred embodiment of the
invention.
[0032] FIG. 15 provides views of one preferred embodiment of the
invention.
[0033] FIG. 16 provides views of one preferred embodiment of the
invention.
[0034] FIG. 17 provides views of one preferred embodiment of the
invention.
[0035] FIG. 18 provides views of one preferred embodiment of the
invention.
[0036] FIG. 19 provides views of one preferred embodiment of the
invention.
[0037] FIG. 20 is a perspective view of one embodiment of a drill
guide instrument for use in installing the compression brackets of
the invention.
[0038] FIG. 21 provides perspective views of drivers for use with
the drill guide instrument of FIG. 20.
[0039] FIG. 22 provides views of a snap-off screw for use with the
compression brace of the invention.
PREFERRED EMBODIMENTS OF THE INVENTION
[0040] 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.
[0041] 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.
[0042] 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.
[0043] A pair of bridge members 50A, 50B are positioned between the
fastener retaining portions 10. The bridge members 50A, SOB
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, SOB 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 SOA, SOB 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.
[0044] 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.
[0045] 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.
[0046] 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
FIG. 11, 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 FIG. 11, 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.
[0047] As shown in FIG. 11, 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.
[0048] As shown in FIG. 12, an alternative preferred fastener 100
is a pin 100. The pin 100 shown in FIG. 12 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.
[0049] In a preferred embodiment shown in FIG. 11, 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.
[0050] 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 FIG. 11, 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.
[0051] 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.
[0052] Snap-off screws, such as the type shown in FIG. 22, 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.
[0053] FIGS. 14-17 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 FIG. 16
are straight, and thus lack the V-shaped configuration of other
embodiments. The configuration of FIG. 16 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.
[0054] 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.
[0055] 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.
[0056] As shown in FIGS. 8-10 and 13, 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-C
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. FIG. 10 also includes 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. 8-10 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. 8-10 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.
[0057] 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.
[0058] 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.
[0059] 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. 8-10 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.
[0060] 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.
[0061] 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.
[0062] 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.
[0063] 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.
[0064] 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.
[0065] 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.
[0066] 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 m
etatarsophalangeal 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.
[0067] 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.
[0068] 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).
[0069] 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.
* * * * *