U.S. patent application number 14/339729 was filed with the patent office on 2015-03-19 for system for making a bone repair.
The applicant listed for this patent is SWISS ORTHO, LLC. Invention is credited to Manuel DaSilva.
Application Number | 20150080967 14/339729 |
Document ID | / |
Family ID | 41415473 |
Filed Date | 2015-03-19 |
United States Patent
Application |
20150080967 |
Kind Code |
A1 |
DaSilva; Manuel |
March 19, 2015 |
SYSTEM FOR MAKING A BONE REPAIR
Abstract
A method and system is provided for repairing bone fractures at
locations where high levels of stability are required. The system
employs two plates to buttress a fracture from both the dorsal and
volar sides. The plates are affixed to one another using screws
that are installed from a volar plate, through the bone and into a
dorsal plate. The method provides for use of a directional guide
that allows the precise placement of Kirschner wires for temporary
fixation of the fracture, installation of a first bone fixation
plate using the installed K-wires for alignment, installation of a
second bone plate adjacent the bone to be repaired and opposite the
first bone plate, and installation of cannulated fasteners between
the two opposing bone plates such that the fasteners rigidly engage
both of the bone plates.
Inventors: |
DaSilva; Manuel; (East
Greenwich, RI) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
SWISS ORTHO, LLC |
East Greenwich |
RI |
US |
|
|
Family ID: |
41415473 |
Appl. No.: |
14/339729 |
Filed: |
July 24, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12209226 |
Sep 12, 2008 |
8821580 |
|
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14339729 |
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60972029 |
Sep 13, 2007 |
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Current U.S.
Class: |
606/281 ;
606/282 |
Current CPC
Class: |
A61B 17/864 20130101;
A61B 17/1728 20130101; A61B 17/8061 20130101; A61B 17/8635
20130101; A61B 17/8014 20130101; A61B 17/848 20130101; A61B 17/1782
20161101; A61B 17/8057 20130101; A61B 17/683 20130101 |
Class at
Publication: |
606/281 ;
606/282 |
International
Class: |
A61B 17/80 20060101
A61B017/80; A61B 17/86 20060101 A61B017/86; A61B 17/84 20060101
A61B017/84 |
Claims
1. A system for fixation of bone fractures comprising: a first
plate having a proximal portion, a distal portion and a plurality
of apertures formed therethrough, said first plate configured to be
received adjacent a first side of a fractured region in a bone; at
least one second plate member having at least one aperture formed
therethrough, said at least one second plate configured to be
received adjacent a second opposing side of said fractured region
in a bone; and at least one fastener having a proximal end and a
distal end, extending between one of said apertures in said first
plate, through said bone and engaging said at least one aperture in
said second plate.
2. The system of claim 1, wherein the apertures in the first plate
are locking apertures configured to engage a head at the proximal
end of the fastener.
3. The system of claim 2, wherein the locking apertures in the
first plate are threaded apertures configured to engage
corresponding threads on the head at the proximal end of the
fastener.
4. The system of claim 1, wherein the at least one aperture in the
at least one second plate is a locking aperture configured to
engage the distal end of the fastener.
5. The system of claim 4, wherein the locking apertures the at
least one aperture in the at least one second plate is a threaded
aperture configured to engage corresponding threads on the distal
end of the fastener.
6. The system of claim 1, wherein the first and at least one second
plates have an inner surface that is contoured to fit the bone held
therebetween.
7. The system of claim 1, wherein the fastener is cannulated.
8. The system of claim 1, wherein the fastener is
self-drilling.
9. The system of claim 1, wherein the at least one second plate is
a plurality of second plates positioned adjacent the opposing side
of the bone.
10. The system of claim 1, wherein the at least one second plate is
a single second plate positioned adjacent the opposing side of the
bone and extending across said fractured region.
11. The bone plate of claim 1, wherein the first plate is
configured to be secured adjacent a volar surface region of the
radius bone and the at least one second plate is configured to be
secured adjacent a dorsal surface region of the radius bone.
12. A method for fixation of bone fractures comprising: positioning
a first plate having a proximal portion, a distal portion and a
plurality of apertures formed therethrough, said first plate
configured to be received adjacent a first side of a fractured
region in a bone; positioning at least one second plate member
having at least one aperture formed therethrough, said at least one
second plate configured to be received adjacent a second opposing
side of said fractured region in a bone; and securing said first
plate to said at least one second plate by installing at least one
fastener having a proximal end and a distal end, between one of
said apertures in said first plate, through said bone and into
engagement with said at least one aperture in said second
plate.
13. The method of claim 12, further comprising: installing a
Kirschner wire into said bone, said Kirchner wire having a first
end extending from one side of said bone and a second end extending
from an opposing side of said bone; positioning said first plate by
aligning one of said plurality of apertures in said first plate
about said first end of said Kirschner wire; and positioning said
at least one second plate by aligning said at least one aperture
about said second end of said Kirschner wire.
14. The method of claim 13, wherein said at least one fastener is
cannulated, said fastener being installed between said first and at
least second plates directly over said Kirschner wire.
15. The method of claim 14, wherein the fastener is
self-drilling.
16. The method of claim 12, further comprising: installing a guide
device, said guide device having a guide element in alignment with
a first aperture in said first plate adjacent a first side of said
bone and a second guide element in alignment with a second position
on an opposing side of said bone; using said guide device to
install a Kirschner wire having a first end extending from said
first aperture and a second end extending from said second position
on said opposing side of said bone; positioning said at least one
second plate by aligning said at least one aperture about said
second end of said Kirschner wire; and securing said first plate to
said at least one second plate by installing at least one fastener
having a proximal end and a distal end and a cannulated passage
extending therebetween, wherein said cannulated passage is
installed over said Kirschner wire, said fastener being directed by
said Kirschner wire between said first aperture in said first
plate, through said bone and into engagement with said at least one
aperture in said second plate.
17. The method of claim 16, wherein the fastener is
self-drilling.
18. The method of claim 12, further comprising: installing a guide
device, said guide device having a guide element in alignment with
a first aperture in said first plate adjacent a first side of said
bone and a second guide element in alignment with a said at least
one aperture in said second plate; using said guide device to
install a Kirschner wire having a first end extending from said
first aperture and a second end extending from said at least one
aperture in said second plate; and securing said first plate to
said at least one second plate by installing at least one fastener
having a proximal end and a distal end and a cannulated passage
extending therebetween, wherein said cannulated passage is
installed over said Kirschner wire, said fastener being directed by
said Kirschner wire between said first aperture in said first
plate, through said bone and into engagement with said at least one
aperture in said second plate.
19. The method of claim 18, wherein the fastener is self-drilling.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is related to and claims priority from
earlier filed U.S. Provisional Patent Application No. 60/972,029,
filed Sep. 13, 2007.
BACKGROUND OF THE INVENTION
[0002] The present invention relates generally to a method and
system for use in the positive and secure positioning of fractured
bones. More specifically, the present invention relates to double
plate assembly for use in repairing bone fractures that
demonstrates improved stability when buttressing fractures that
exhibit complex articular patterns and comminution.
[0003] The human skeleton consists of 206 individual bones that
cooperate to perform a variety of important functions such as
support, movement, protection, storage of minerals, and formation
of blood cells. The bones within the skeleton are generally grouped
into two categories, the axial skeleton and the appendicular
skeleton. The axial skeleton includes 80 bones that make up the
body's center of gravity and the appendicular skeleton includes the
remaining 126 bones that make up the body's appendages.
[0004] When a person suffers a bone injury such as a bone fracture,
it is important that the fractured bone be repaired promptly and
properly. When such a fracture is severe enough, repair often
requires remedies that may include surgical intervention. The
typical treatment for a fractured bone involves the use of a
fixation device that serves to reinforce the fractured bone and
keep the adjacent portions of the bone aligned during healing. A
wide variety of fixation devices are employed to maintain bone
alignment. Further, these bone fixation devices take a variety of
forms, including external devices such as casts and internal
devices such as bone plates and screws. As can be appreciated by
one skilled in the art, bone repairs employing external devices are
minimally invasive, allowing reduction and fixation of simple
fractures from outside the body. In contrast, bone plates are
internal devices that mount directly to bone to span and support
the fracture and require a fairly invasive process for placement
and installation thereof.
[0005] While most bones in the skeleton are susceptible to injury
or fracture, the repair method used depends on the location of the
bone and the proximity of the break to a joint. Further, some bones
require a more precise repair as compared to others in order to
insure stability of the joint. For example, the radius is one of
two long bones found in the human forearm. Distal fractures of the
radius are a common result of forward falls, with the palms facing
downward, particularly among the elderly. In such falls, force
exerted on the distal radius at impact frequently produces dorsal
displacement of one or more bone fragments created distal to the
fracture site. Unfortunately, internal fixation of such dorsally
displaced bone fragments using bone plates has proved problematic.
Using dorsal fixation, a surgeon may apply a reducing force on the
fracture by attaching a bone plate to the dorsal side of the
radius. However, unless the bone plate has a very low profile,
dorsal tendons overlying the bone plate may rub against it,
producing tendon irritation or even tendon rupture.
[0006] Alternatively, fixation may be performed volarly. In this
approach, a surgeon may attach a bone plate to the volar side of
the radius. The volar side of the radius may be more accessible
surgically and defines a distal pocket in which the distal portion
of the bone plate may be disposed. Accordingly, the bone plate may
be less obtrusive and its placement at this location may produce
less tendon irritation, even if the bone plate is thicker and
sturdier. However, while volar fixation provides advantages as
compared to dorsal fixation, there are settings where a single
volar or dorsal implant does not provide enough stability to
provide reliable support for the bony structures. This is
particularly problematic in elderly patients that generally have
poor quality bone or in high-speed injuries with highly comminuted
fracture patterns. In these situations, bone screws used for
fastening the plate in place are inserted through openings in the
plate. The difficulty is that when the screws are installed into
the distal radius, they may not find sufficient bone structure to
hold distal bone fragments in position against the bone plate. In
addition, it should be appreciated by one skilled in the art that
this scenario is not unique to distal radius fractures. It also
happens, for example, in distal humerus, proximal olecranon, distal
ulna, proximal tibia and distal tibia (pilon) injuries when in
certain situations it is necessary to use double plates in order to
provide the best mechanical construct.
[0007] Therefore there is a need for an alternative strategy for
reducing and fixing bone fractures that exhibit complex articular
patterns and comminution. There is a further need for a method and
system that retains the fractured portions of bone in a rigid
structure that does not rely on fastening directly to the bone
itself for reducing and fixing the bone fracture
BRIEF SUMMARY OF THE INVENTION
[0008] In this regard, the present invention provides a method and
system for making a bone repair that is useful in repairing bone
fractures at fracture locations where high levels of stability are
required. Generally, the present invention is directed to a bone
repair system that employs two plates to buttress a fracture from
both the dorsal and volar sides and a method of employing the
system to achieve an effective bone repair. The plates are affixed
to one another using screws that are installed from a volar plate,
through the bone and into a dorsal plate. The use of these
complimentary dorsal and volar plates creates a highly stable
repair structure while requiring fewer screws as compared to the
prior art.
[0009] In one preferred embodiment of the present invention two
bone plates are employed on opposing sides of the bone that has
suffered a fracture that must be buttressed. Depending on the
extent and severity of the fracture being buttressed, the method
and system of the present invention may employ two full plates
extending along opposing sides of the bone or a full plate on the
volar side of the bone and at least one partial plate on the dorsal
side. Generally, the object of the present invention is to provide
a volar plate that spans and buttresses the fracture while
providing at least one secondary dorsal plate that provides support
into which the bone screw extending upwardly from the volar plate
engages thereby eliminating the need to anchor the bone screw in
the bone structure itself.
[0010] By installing the bone plates of the present invention,
fixation of the bone fragments is achieved using screws that engage
both the dorsal and volar plates in a manner that rigidly maintains
the plates in position relative to one another and the bone to be
repaired without requiring that the fasteners engage with the bone
itself. This allows the method and system of the present invention
to be particularly useful in applications where the fractures is
particularly severe, exhibiting complex articular patterns and
comminution and applications where the fasteners cannot be reliably
fastened into the bone itself.
[0011] Additionally, the method provided in the present invention
provides for the insertion of a first Kirschner wire (K-wire) for
temporary reduction and fixation of the fracture. Installation of
at least a first bone fixation plate using the installed K-wires
for alignment. Installation of at least a second partial bone plate
adjacent the bone to be repaired and opposite the first bone plate.
Installation of fasteners that fasten the two opposing bone plates
to one another such that the fasteners rigidly engage both of the
bone plates.
[0012] It is therefore an object of the present invention to
provide a method and system for reducing and fixing bone fractures
that exhibit complex articular patterns and comminution. It is a
further object of the present invention to provide a method and
system that retains the fractured portions of bone in a rigid
structure that does not rely on fastening directly to the bone
itself for reducing and fixing the bone fracture.
[0013] These together with other objects of the invention, along
with various features of novelty that characterize the invention,
are pointed out with particularity in the claims annexed hereto and
forming a part of this disclosure. For a better understanding of
the invention, its operating advantages and the specific objects
attained by its uses, reference should be had to the accompanying
drawings and descriptive matter in which there is illustrated a
preferred embodiment of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] In the drawings which illustrate the best mode presently
contemplated for carrying out the present invention:
[0015] FIG. 1 is a perspective view of the system of the present
invention installed about a bone;
[0016] FIG. 2 is a cross-sectional view of the system of the
present invention along line 2-2 of FIG. 1;
[0017] FIG. 3 is a cross-sectional view of the system of the
present invention along line 2-2 of FIG. 1 depicting an alternate
dorsal plate;
[0018] FIG. 4 is an illustration of various fasteners and locking
aperture configurations that may be employed in the context of the
present invention;
[0019] FIG. 5 is a guide device employed in the bone repair system
of the present invention; and
[0020] FIGS. 6a-6d are illustrations showing the method of the
present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0021] Now referring to the drawings, the bone repair system of the
present invention is shown and generally illustrated at FIGS. 1-5
while the method of the present invention is depicted at FIG. 6.
Generally, the present invention is directed to a bone repair
system that employs two complimentary opposing plates to buttress a
fracture from both sides of a bone. In one example, in a repair
involving a wrist fracture, the plates are affixed to one another
using screws that are installed from a volar plate, through the
bone and into the dorsal plate. The use of these complimentary
volar and dorsal plates creates a highly stable repair structure
while requiring fewer screws thereby minimizing the degree of soft
tissue dissection.
[0022] Turning now to FIG. 1, in the preferred embodiment of the
present invention two complimentary opposing bone plates 2, 4 are
employed on opposing sides of the bone 6 having the fracture 8 to
be buttressed. While the bone 6 to be repaired as depicted in FIG.
1 is the radius, one skilled in the art can appreciate that the
method and system of the present invention is equally applicable to
a number of bones throughout the body and accordingly, the
teachings of this invention are not limited to the repair of the
radius but are equally applicable to any fracture that requires a
high stability repair. Generally, the object of the present
invention is to provide a first plate 2 that spans and buttresses
the fracture while providing at least one secondary plate 4 that
provides support into which the bone screw extending upwardly from
the volar plate engages, as will be described in detail below,
thereby eliminating the need to anchor the bone screw in the bone 6
structure itself.
[0023] Turning now to the cross-sectional view depicted at FIG. 2
in connection with FIG. 1, it can be seen that the first plate 2 is
preferably a full plate installed adjacent the volar side of the
bone and includes holes 10 or more preferably slots therein that
allow the placement of bone screws 12 therethrough. The holes 10 or
slots are configured to allow the shank of the screw 12 to pass yet
to engage the head of the screw 12 once the screw 12 is fully
installed and tightened. The at least one secondary plate 4
positioned adjacent the dorsal side of the bone includes a hole 14
therein that is particularly configured to receive and engage the
threads on the distal end 13 of the screw 12 opposite the head 11.
Upon tightening of the screw 12, the screw 12 draws the secondary
plate 14 against the fractured bone fragment 8 drawing the
fractured bone fragment 8 against the first plate 2 and clamping
the bone 6 between the two complimentary opposing plates 2,4.
[0024] The plates 2,4 and fasteners 12 may be formed from any
medical grade material suitable for permanent placement within the
human body including but not limited to titanium, stainless steel,
and absorbable materials. Further, it should be appreciated by one
skilled in the art that the inner surfaces of the first and second
plates 2,4 may be provided with an inner surface that is contoured
to fit the bone 6 held therebetween.
[0025] FIG. 3 depicts an alternate cross-sectional view wherein a
second plate employed on the dorsal side is actually a pair of
partial plates 4a,4b that are installed at the fastener 12
locations. In this regard, it should be appreciated that the
present invention may also be implemented by installing a full
plate 2 on the volar side and at least one partial plate 4a on the
dorsal side or a plurality of partial plates 4a, 4b on the dorsal
side.
[0026] In the most general sense therefore, referring back to FIGS.
1-3, the present invention provides a system for fixation of bone
fractures that includes a first plate 2 having a proximal portion
7, a distal portion 9 and a plurality of apertures 10 formed
therethrough, wherein the first plate 2 is configured to be
received adjacent a first side of a fractured region 8 in a bone 6.
At least one second plate member 4 is provided wherein the second
plate 4 includes at least one aperture 10 formed therethrough, the
second plate 4 being configured to be received adjacent a second
opposing side of the fractured region 8 in a bone 6. Finally, a
fastener 12 having a proximal end 11 and a distal end 13 is
installed through the bone 6 to engage the first plate 2 and second
plate 4 via the apertures 10 therein in order to lock the plates
2,4 relative to one another and provide stability and support to
the fractured region 8.
[0027] Turning now to FIG. 4, a plurality of fastener
configurations 12a, 12b, 12c are depicted that is suitable for use
in connection with the present invention. In the most general
sense, as depicted in the first fastener 12a at the left of FIG. 4,
the fastener 12 a is a screw that includes a head 11a that engages
with the aperture 10 formed in the first plate 2 either using the
tapered head or a pan head screw residing in a recess formed in the
top surface of the first plate 2 so that the screw head 11a does
not protrude over the top surface of the plate 2 resulting in
irritation of the tissues surrounding the plate 2. At the distal
end 13a of the faster 12a, threads are shown that engage with
corresponding threads 15a in the aperture 10 formed in the second
plate 4. Again, a fastener 12a is employed of the appropriate
length such that the distal end 13a does not protrude through the
surface of the second plate 4.
[0028] The second fastener 12b depicted at the center of FIG. 4
shows threads 15b, 17b on both the head at the proximal end 11b of
the fastener 12b as well as distal end 13b of the fastener 12b
wherein the threads 17b, 15b on the fastener 12b engage
corresponding threads formed in the apertures 10 of the first plate
2 and second plate 4. This allows the plates 2, 4 to be engaged
with one another and maintained in rigid spaced relation relative
to one another despite the condition of the bone at the fractured
region. It should be further appreciated that the threading shown
and described herein is intended to be of a locking type such as
known in the art wherein a differential in the thread pattern on
the screw and the thread pattern in the aperture causes the screw
to lock relative to the plates once installed and fully tightened.
Such locking methods are well known in the art and therefore do not
need to be more fully detailed herein.
[0029] Turning to the fastener 12c depicted at the left of FIG. 4,
the faster 12c is shown to be cannulated. In other words, the
fastener 12c includes a passage 19 therethrough that extends
between the proximal 11c and distal ends 13c. Such a passageway 19
allows the screw 12c to be installed over a guide such as a
Kirchner wire (K-wire) as will be described in more detail below.
Further, the distal end 13c of the fastener 12c is preferably
self-drilling to allow it to be installed directly through the bone
in accordance with the method as detailed below.
[0030] FIG. 5 shows a guide device 20 for use in connection with
the bone repair system of the present invention. The guide device
20 has a body 22 that includes an alignment tube 24 extending
therethrough. The guide tube 24 is positioned adjacent an aperture
10 in the first plate 2. In addition, the guide device 20 includes
a secondary guide element 26 that extends thereform wherein the
secondary guide element 26 is positioned in alignment with an
aperture 10 in the second plate 4 on the opposite side of the bone
6. In this arrangement, the guide device 20 holds the first plate 2
and second plate 4 in compression relative to one another and the
guide tube 24 is held in alignment such that the longitudinal axis
of the guide tube 24 is precisely aligned through the apertures 10
in the first and second plates 2, 4.
[0031] In terms of a method for repairing a bone fracture, the
present invention provides a method for fixation of bone fractures
as depicted at FIGS. 6a-6d. In the most general embodiment of the
method, a first plate 2 having a proximal portion, a distal portion
and a plurality of apertures 10 formed therethrough is positioned
adjacent a first side of a fractured region in a bone 6, at least
one second plate 4 member having at least one aperture 10 formed
therethrough is then positioned adjacent a second opposing side of
said fractured region in a bone 6. With the plates 2, 4 positioned,
the first plate 2 and second plate 4 are secured to one another
using at least one fastener 12 having a proximal end and a distal
end that engages between one of the apertures 10 in the first plate
2, through the bone 6 and into one of the apertures 10 in the
second plate 4.
[0032] More preferably the method includes a step as shown at FIG.
6a wherein a Kirschner wire 28 is installed through the bone.
Preferably this installation is accomplished using a guide 20 such
as is depicted at FIG. 5 to precisely align and install the K-wire
28 into the bone. The K-wire 28, upon installation includes a first
end 28a extending from one side of the bone 6 and a second end 28b
extending from an opposing side of the bone 6. Once the K-wire 28
is installed, the first plate 2 is positioned by aligning one of
the plurality of apertures 10 therein about the first end 28a of
the Kirschner wire 28 (see FIG. 6b). Subsequently, the at least one
second plate 4 is positioned about the second end 28b of the
Kirschner wire 28 (see FIG. 6c). Finally, a cannulated fastener 12
is installed directly over the K-wire 28 such that the fastener 12
is self-drilling and is guided into place about the K-wire 28 (see
FIG. 6d). The fastener 12 then engages the first plate 2 and second
plate 4 as described above.
[0033] Alternately, the steps of the method may proceed by first
installing a guide device 20 in alignment with a first aperture 10
in the first plate 2 adjacent a first side of the bone 6 such that
the guide device 20 secondary guide element 26 is in alignment with
a second position on an opposing side of the bone 6. The guide
device 20 is then used to install a Kirschner wire 28 having a
first end 28a extending from the first aperture 10 and a second end
28b extending from said second position on the opposing side of the
bone 6. Next, at least one second plate 4 is positioned by aligning
at least one aperture 10 therein about the second end 28b of the
Kirschner wire 28. Finally, the first plate 2 is secured to the at
least one second plate 4 by installing at least one fastener 12
having a proximal end and a distal end and a cannulated passage
extending therebetween, wherein the cannulated passage is installed
over the Kirschner wire 28, such that the fastener 12 installation
is directed by the Kirschner wire 28 between the first aperture 10
in the first plate 2, through the bone 6 and into engagement with
the at least one aperture 10 in the second plate 4. Further, the
above process may be accomplished by first positioning the first
plate 2 and second plate 4 and aligning the guide device 20 using
the apertures 10 therein.
[0034] Such a system as disclosed within the present invention
provides for the application of high rigidity buttressing to
fractures without requiring that the screw anchor into the bone
fragments themselves. As a result, fewer screws are required to
secure fractures exhibiting comminution and higher stability is
achieved.
[0035] It can therefore be seen that the present invention provides
a system and method that facilitates the application of high
rigidity buttressing to fractures without requiring that the screw
anchor into the bone fragments themselves. As a result, fewer
screws are required to secure fractures exhibiting comminution and
higher stability is achieved. For these reasons, the instant
invention is believed to represent a significant advancement in the
art, which has substantial commercial merit.
[0036] While there is shown and described herein certain specific
structure embodying the invention, it will be manifest to those
skilled in the art that various modifications and rearrangements of
the parts may be made without departing from the spirit and scope
of the underlying inventive concept and that the same is not
limited to the particular forms herein shown and described except
insofar as indicated by the scope of the appended claims.
* * * * *