Note: Descriptions are shown in the official language in which they were submitted.
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Title: Orthopaedic device to be associated with the outside of a bone
DESCRIPTION
Field of application
The present invention refers in its most general aspect to the field of
orthopaedics, in particular to an orthopaedic device to be associated with the
outside of a bone, such as, for example, an external fixator for the
ostheosynthesis of a bone fracture, or an orthopaedic device for correcting
bone
deformation or malformation, or for the reconstruction of defective bone. Such
an orthopaedic device is of the type comprising one or two clamps mounted on
a support rail that are moved in an incremental manner reciprocally nearer to
or further away from each other by means of a compressor/distractor device.
Even more particularly the present invention concerns a clamp for the
support of endosseous screws that is slidably mounted on said orthopaedic
device.
For the sake of brevity and simplicity the following description refers
specifically to an orthopaedic device and to the related clamps for the
correction of deformations in long bones, but it is intended that this may, by
analogy, also be extended to any external orthopaedic device with at least two
clamps mounted on a support rail, themselves connected by means of the
compressor/distractor device.
Prior art
In orthopaedics the use of orthopaedic devices that are associated with
the external part of a bone and equipped with clamps to support endosseo-us
screws that can be inserted into long bones transversely, is well known, for
instance for the correction of a deformation of the bone, or for the
osteosynthesis of a fracture.
Normally such orthopaedic devices contain two clamps located at a set
distance from each other on a support rail. Each clamp usually contains a
lower jaw and an upper jaw, closed onto each other, with transverse grooves
for
guiding the endosseous screws.
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More particularly a first clamp is placed in correspondence with a
proximal part of the bone in order to insert the first endosseous screws in
that
position, and the other clamp is placed in a corresponding distal position of
the
bone in order to insert the second endosseous screws in that position.
When the orthopaedic device is used for the correction of deformed long
bones, the correction is usually carried out by subjecting the bone to
osteotomy
between the distal and the proximal portion and maintaining contact between
the two bone extremities through the endosseous screws. Successively the two
clamps are moved at incremental steps along the support rail with the help of
a
distractor/compressor device so that step by step bone callus is generated
between the extremities.
More particularly the distractor/compressor device is formed by an
operator screw that is connected to the clamps by means of respective
connection pins that are inserted into corresponding holes or cylindrical
cavities in the body of each clamp. By rotating the screw it is then possible
to
obtain a relative displacement of the two clamps and as a result a movement
further apart or closer together of the positions of the extremities of the
bones
attached to them.
Such an orthopaedic device, even though it has many advantageous
aspects and although it basically obtains the goal for which it is intended,
nevertheless presents known inconveniences that have not yet been overcome.
The main inconvenience of such orthopaedic devices is due to the fact
that the clamps take up a great deal of space due to their overall size,
because
of the necessity of having to accommodate within each clamp's body a plurality
of components and functional elements, such as the guiding grooves for the
endosseous screws, the endosseous screws themselves, the holes for receiving
the connection pins of the compressor, the clamping screws of the two jaws, as
well as means for blocking the jaws on the support rail. To sum up, a
plurality
of fastening means has to coexist in the body of each clamp.
The large dimensions of the clamps consequently bear down heavily on
the overall weight and dimensions of the orthopaedic device, as well as on the
maximum number of clamps that can be placed on a support rail, within a
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determined weight.
The technical problem at the basis of the present invention is that of
devising a clamp and an orthopaedic device including such a clamp, with such
structural and functional characteristics that the abovementioned
inconveniences in view of the prior art are overcome, and in particular a
device
that may use a clamp with dimensions that are smaller than those of the
clamps of the prior art but with support for an equal number of endosseous
screws.
Summary of the invention
The technical problem is resolved by an orthopaedic device of the type
described previously and comprising a support rail, extending along a central
longitudinal axis substantially parallel to the bone, at least two clamps
mounted slidably along said axis on the support rail and supporting
endosseous screws that can be inserted into the bone, and a
distractor/compressor device that can be removably coupled with the two
clamps by means of respective connection pins inserted into corresponding
holes on each clamp, wherein each clamp comprises a clamp body with a base
or lower jaw, and a lid or upper jaw, as well as a screw for fixing the upper
jaw
to the lower jaw, characterised by the fact that at least one of said two
clamps
comprises two holes for the connection pins that are aligned on a line that is
extended substantially parallel to said axis, with at least one hole for the
connection pins of the remaining clamp also being aligned along said line.
Advantageously the device according to the invention distinguishes itself
also by the fact that the support rail has a double T-profile, and two opposed
grooves where in the centre of each groove a longitudinal slot is extended;
the
clamping screws of the clamps being arranged along the axis of the support
rail.
Moreover, each T-portion of the rail has a wing with end segments bent
into an L-shape, so that the two grooves also have a substantially T-shaped
form, intended to receive by insertion a conjugate T-shaped projection of the
lower jaw of each clamp.
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Furthermore, there are four holes for the connection pins, arranged two
by two along respective lines that extend substantially parallel equidistant
on
either side of the central longitudinal axis of the support rail.
The invention also regards the distinguishing characteristics of a group
of clamps in accordance with claims 5 to 15. Further characteristics and
advantages of the orthopaedic device and the group of clamps according to the
invention will become clear from the following description of a number of
embodiments, provided by way of non-restrictive example and with reference to
the enclosed drawings.
Brief description of the drawings
Figure 1 is a perspective view of a first embodiment of an orthopaedic
device according to the invention;
Figure lA shows a perspective view of a detail of the orthopaedic device
of Figure 1;
Figure 2 is a side view of the device of Figure 1; =
Figure 3 is a perspective view of a clamp according to the invention
associated with the orthopaedic device of Figure 1;
Figure 4 is a plan view of the clamp of Figure 3;
Figure 5 is a cross-section view along the lines V-V of Figure 4;
Figure 6 is a cross-section view along the line VI-VI of Figure 4;
Figure 7 is a perspective view of a detail of the orthopaedic device of
Figure 1;
Figure 8 is a cross-section view along the line VIII-VIII of Figure 7;
Figures 9 and 9A respectively are perspective views of a second
embodiment of an orthopaedic device according to the invention, seen from two
different angles;
Figure 10 is a perspective view of a clamp of the orthopaedic device of
Figure 9;
Figure 11 is a view of a detail of the clamp of Figure 10;
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Figure 12 is a plan view of the clamp of Figure 10;
Figure 13 is a cross-section along the line XIII-XIII of the clamp of Figure
12.
Detailed description
5 With
reference to the Figures, the reference numbers 10, 110 indicate
two different embodiments of an orthopaedic device to be associated with the
exterior of a bone, such as for example an external fixator for the
osteosynthesis of a fractured bone, or an orthopaedic device for correction of
deformed or malformed bones, or for the reconstruction of defective bones.
Such an orthopaedic device 10, 110 is of the type comprising two or more
clamps mounted on a support rail, and moveable in an incremental manner
nearer to or further away from each other by means of a compressor/ distractor
device.
In the example of Figure 1, the orthopaedic device 10 is intended to
correct deformations in a long bone 11 such as a tibia or a femur, in
correspondence to a substantially central zone of the bone, whereas the
orthopaedic device 110 of Figure 9 is intended to correct deformations in
relation to the metaphysis of a femur 111 or of a tibia.
More particularly, as the relative figures mentioned above illustrate, in
order to allow for the correction of the deformation, the bone 11 has pre-
emptively been subjected to osteotomy with the formation of two extremities
11a, 11b.
The orthopaedic device 10 contains a rail 12, which in the example is
made of a fibre-reinforced thermoplastic material, such as the material
commercially known as Orthtek WF , carbon fibre in epoxy resin pultrusion,
or known commercially as Peek CA300, or in an aluminium alloy. The rail 12 is
extended longitudinally along a determined central axis Y-Y, placed laterally
and substantially parallel to the bone 11.
In the example, as can be seen in Figures 7 and 8, the rail 12 has a
double-T profile, and comprises two opposed grooves 15a, 15b. Even more
particularly, as shown in Figure 8, each T-shaped portion of the rail 12 has
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wings with the end segments bent into an L-shape so that also the two grooves
15a, 15b have a substantially T-shaped form. In the centre of each of the
grooves 15a, 15b there is a longitudinal slot 13;
The device 10 moreover comprises at least a first clamp 14 that supports
a first group of two endosseous screws 16 inserted into the first bone
extremity
11a, and a second clamp 18 that supports a second group of endosseous
screws 20 inserted into the second bone extremity 1 lb. Both clamps are made
of fibre-reinforced thermoplastic material, such as the material commercially
known as Peek CA300, or in an aluminium alloy. The endosseous screws 16,
20 are made of implantable steel or titanium alloy.
In the example the two clamps 14, 18 are mounted directly on the rail
12, in a removable manner, and they are identical.
Each clamp 14, 18, as illustrated with reference to the clamp 18 in
Figures 3, 4, 5 and 6, comprises a clamp body with an upper jaw 23, which
forms the removable lid of the clamp, and a lower jaw 24, which forms the
fixed
base of the clamp, which close onto each other by means of two clamping
screws 25, 26, made in the example of steel and/or titanium alloy.
Both jaws 23 and 24 have a substantially rectangular shape, with the
respective shorter sides 23a, 23b, 24a 24b of a relatively limited length,
around
40mm in the example, and the respective longer sides 23c, 23d, 24c, 24d of a
length relatively limited of around 48mm in the example. Basically, in the
example, the body of the clamp has a maximum overall length not exceeding 50
mm.
More particularly the lower jaw 24 has a transverse profile of a
substantially "T"-shaped form with the vertical tail 27 also having a profile
in
the shape of an upside-down T, which is slidably inserted into the conjugate
groove 15a of the rail 12. The lower jaw 24 is fastened in a specific
longitudinal
position on the rail 12 by means of a blocking screw 28 inserted into the
longitudinal slot 13.
Moreover each jaw 23, 24 comprises respective transversal guiding
grooves 29a, 29b, defining seats 29 for guiding, and housing the endosseous
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screws 16, 20. In the example the guiding grooves 29a, 29b have a profile that
is substantially V-shaped to receive endosseous screws of different diameters;
also in the example the grooves have an angular width of 900, and receive
screws with a diameter of 5 or 6 mm.
The first clamp 14 and the second clamp 18 are connected by means of a
compressor/distractor device 58, which allows for the displacement, in an
incremental manner, relatively nearer to or further away from each other, of
the two clamps 14, 18 and therefore also of the two extremities 1 la, 1 lb.
The
compressor/distractor 58 is connected to the clamps by means of connection
pins 68 and 69 that are inserted with pressure into the corresponding holes
64, or hollows, with a cylindrical form and internally smooth, in the clamps
14,
18.
In the present invention at least one of the two clamps 14 or 18
comprises two holes 64 for the insertion of one of the two connection pins 68,
69 of the compressor/distractor 58, the remaining connection pin being
inserted into a further hollow located on the other clamp 18 or 14. The two
holes of the first clamp and the remaining hole of the second clamp are
aligned
along a line X that extends substantially parallel to the central longitudinal
axis Y-Y of the rail 12.
In the preferred embodiment each clamp 14, 18 has four holes for the
connection pins, aligned two by two along respective lines X that extend
substantially parallel to the central longitudinal axis Y-Y of the rail,
placed
equidistant from this axis Y-Y.
According to one aspect of the invention the holes 64 for the insertion of
the connection pins 68 and 69 are placed next to each other and aligned with
the clamping screws 25, 26 of the respective clamps 14, 18, along a line L
that
is substantially parallel to the guiding grooves 29a, 29b, transversal with
respect to the central axis Y-Y of the rail, in effect, in the example,
forming a
right angle with the Y-Y axis of the rail.
Each clamp 14, 18 comprises four holes 64. In particular, each clamp
14, 18 comprises two holes 64 aligned on opposite sides with respect to the
first clamping screw 25, and two holes 64 aligned and on opposite sides with
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respect to the second clamping screw 26. There are, therefore, two alignments
or rows, each including two holes 64 and a screw 25, 26 at the centre.
According to another aspect of the invention the holes 64 extend in depth
both into the upper jaw 23 and into the lower jaw 24 of each clamp 14, 18.
Basically each pin 68 of the compressor/distractor 58 is inserted deeply into
the body of each clamp.
Consequently it follows that for reasons of size, the holes 64 and the
screws 25, 26 of the respective clamp 14, 18 are located in parts of the clamp
14, 18 that are not occupied by the guiding grooves 29a, 29b. As is clearly
illustrated by the side view of Figure 2 and the cross sections of Figures 5
and
6, along the transverse section parallel to the long side 23c, 23d, 24c, 24d
of
the clamp 14, 18, the grooves 29a, 29b, and the two lines L or rows of screws
25, 26 and holes 64 alternate.
According to another aspect of the invention each clamp 14, 18 contains
five transverse seats 29 for osseous screws, distributed as follows: one
central
group of three seats 29 for osseous screws, and two lateral seats 29, each in
correspondence with a lateral zone or side of the relative clamp 14, 18,
substantially in correspondence with the edge of the short side 23a, 23b, 24a,
24b. In this configuration each row of screws 25, 26 and holes 64 is located
next to a central group of seats 29, between the latter and a respective
lateral
seat 29.
Moreover it is possible to observe how in all clamps the four holes 64
described above are placed at the corners of a rectangle, in proximity to the
four corners of the relative clamp 14, 18.
This configuration allows for more possible choices for the position of the
insertion of a respective pin 68 of the compressor/distractor 58.
In the illustrated solution the compressor/distractor 58 comprises a
sleeve 59 that is threaded internally, in correspondence to a portion of the
extremity 66 from which a first pin 68 is affixed, a cylindrical shaft 63 to
which
a second pin 69 is attached, and an operator screw 54 with head 60, housed in
the cylindrical shaft 63 and provided with a countersunk hexagon and stem 61
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whose external threading matches the internal threading of the sleeve 59. The
compressor/distractor 58 moreover contains an annular body 65 solidly in
rotation with the stem 61 of the screw, and placed near the cylindrical shaft
63, functioning as an axial stop 12.
Once the connection pins 68 and 69 have been inserted into the
corresponding holes 64 of the clamps 14, 18 it is sufficient to rotate the
screw
by inserting a key into the countersunk hexagon of the head 60 to obtain a
relative displacement of the two clamps 14 and 18 along the rail 12, and as a
result a displacement, nearer to or further away from each other, of the
positions of the bone extremities connected to them.
To allow a user to safely control the relative displacement of the clamps
14, 18 the compressor 58 comprises a button element 70, provided on the edge
of a prominence 71 that is inserted into a corresponding notch 72 present on
the external surface of the head 60.
In particular the head 60 of the screw has four notches, staggered at 900
.
In order to operate the screw 54, the button element 70 is pushed in order to
disengage the prominence 71 from the notch 72. The screw is then made to
rotate until it engages, by means of pressure on the button element 70, the
prominence 71 of the next notch or the one after that. This allows a user to
know that a quarter turn or a half turn of the screw 54 has been completed,
which in the example corresponds to a reciprocal displacement of the clamps of
0,25 mm or 0,5 mm respectively.
The main advantage of the clamp and the related orthopaedic device
according to the present invention, lies in the fact that it possesses a
greater
number of seats for transverse screws while maintaining generally modest
measurements. In fact the clamping screws side by side with the holes for the
insertion of the pins of the compressor together occupy a reduced space of the
body of the clamp, leaving more room available for the guiding grooves, and
thus for the endosseous screws. In this manner the clamp according to the
present invention has dimensions that are altogether reduced while at the
same time maintaining the same number of guiding grooves as a clamp known
from the prior art.
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For example, in the illustrated embodiments the clamp has five
transverse seats, that allow for ample choice in the reciprocal placement of
the
two endosseous screws.
A further advantage lies in the fact of the specific distribution of the two
rows of holes, alternating between a central group of at least three guiding
grooves, and two lateral guiding grooves. This disposition allows for further
greater possibilities in the choice of position of the two endosseous screws,
e.g.
both in the central group, or one in the central group and one in a lateral
groove, etc..
Yet another further advantage lies in the fact that the clamp has four
holes for the insertion of the pins, which creates a sufficiently wide margin
of
freedom in the choice of the most useful arrangement of the
compressor/distractor with respect to the clamps and the rail, when the
orthopaedic device is mounted next to the bone.
A further advantage of the clamp according to the present invention lies
= in the fact that it is possible to insert the pins of the
compressor/distractor
deeply into both jaws, which guarantees great stability in the connection with
the relative clamps.
Now, with particular reference to the Figures 9-13 a second embodiment
of an orthopaedic device according to the present invention will be
illustrated.
The orthopaedic device 110 contains at least a first clamp 114, and a
second clamp 118, both mounted on a rail 112 which has the same structure
and function as the rail 12 previously described.
More particularly the second clamp 118 is the same as the clamp 14, or
18 of the previously described embodiment, supporting a group of endosseous
screws 120 inserted in the proximal extremity 111b of a bone 111, whereas
clamp 114 constitutes the main clamp of a group of clamps mounted on the
rail 112 at one of its extremities, and that support endosseous screws 116,
122
inserted into a metaphyseal region of the bone 111 (distal bone extremity
111a).
In particular the group of clamps contains, in addition to the main clamp
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114, an auxiliary clamp 119 that is located on the main clamp 114 and that
supports the respective endosseous screws 122.
The auxiliary clamp 119 is placed on the main clamp 114 in such a
manner that the respective endosseous screws 116 and 122 are located on
planes P and P', together substantially forming a right angle.
In particular the main clamp 114 contains an upper jaw 123, which
constitutes the removable lid of the clamp, and a lower jaw 124, forming the
base of the clamp, closed between them by means of two clamping screws 125,
126.
The upper jaw 123 has a substantially rectangular shape, similar to the
upper jaw in the previously described embodiment, with short sides 123a,
123b of 40 mm and long sides 123c, 123d of 48 mm.
The lower jaw 124, just as in the previously described embodiment,
contains a central body 127a, substantially having the shape of a rectangular
plate of relatively small dimensions, in the example 53,7 mm x 40 mm, with a
vertical tail 131 that protrudes from the central body 127a and that is
slidably
inserted into a groove 115 of rail 112 that has the shape of an upside-down T,
fixed in a specific longitudinal position by means of a blocking screw 133.
Each jaw 123, 124 moreover contains transverse guiding grooves 129a,
129b respectively defining seats 129 for guiding and housing the endosseous
screws 116.
The main clamp 114 and the clamp 118 are connected by means of a
compressor/ distractor device 58, which allows for the incremental
displacement, either closer to or further away from each other, of the two
clamps 114, 118, and therefore of the two bone extremities 111a, 111b. The
compressor/distractor 58 is connected to the clamps by means of connection
pins 68 of the type previously described, inserted by means of pressure into
the
corresponding holes 164, or hollows, of a cylindrical shape and internally
smooth, in the clamps 114, 118.
According to the present invention at least one of the two clamps 114 or
118 contains two holes 164 for the insertion of one of the two connection pins
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68, 69 of the compressor/distractor 58, the remaining connection pin being
inserted into a further hole in the other clamp 118 or 114. The two holes of
the
first clamp and the remaining hole of the second clamp are aligned along a
line
X' that extends substantially parallel to the central longitudinal axis Y-Y of
the
rail 112.
In its preferred embodiment each clamp 114, 118 presents four holes for
the connection pins, aligned two by two along respective lines X' that extend
substantially parallel to the central longitudinal axis Y-Y of the rail,
placed
equidistant from said axis Y-Y.
According to an aspect of the invention the holes 164 for the insertion of
the connection pins 68 of the compressor/distractor are placed alongside each
other and aligned with the clamping screws 125, 126 of the clamp 114, along a
line L' substantially parallel to the guiding grooves 129a, 129b, transverse
with
respect to an axis Y-Y of the rail 112.
In the example the clamp 114 comprises four holes 164. In particular
each clamp 114 contains two holes 164 aligned, on opposite sides, with the
first clamping screw 125, and two holes 164 aligned, on opposite sides, with
the second clamping screw 126. There are, therefore, two alignments or rows,
each including two holes 164 and a screw.
Also in this embodiment the holes 164 extend in depth through the
upper jaw 123 and into the lower jaw 124. Moreover, also in this embodiment
all along the transverse section parallel to the long side of the clamp 114
there
are alternating grooves 129a, 129b and two rows of screws 125, 126 and holes
164; in particular one may note a group of three seats 129 in the centre, and
a
seat 129 on each side of the clamp 114.
The lower jaw 124 moreover comprises, next to the vertical tail 131, a
substantially cylindrical collar-shaped appendix 127b, of axis Z-Z, protruding
from the central body 127a and intended to receive a corresponding cylindrical
appendix 132 of the auxiliary clamp 119, partially visible in Figure 13, which
is
blocked by means of a screw 130. The cylindrical collar 127b is provided with
a
slot 134 in which the screw 130 is accommodated, wherein this slot 134
extends on the cylindrical surface on an arc of a circle which subtends an
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angle of about 350 with the centre on the axis Z-Z. The connection between the
appendix 132 and the cylindrical collar 127b allows for the angular movement
on the plate P' of the auxiliary clamp 119, obtaining a regulation of the
angular
position of the two clamps 114 and 119.
The auxiliary clamp 119 in turn comprises a lower jaw 138 with is made
of one piece with the abovementioned connection appendix 132, and an upper
jaw 137, which are closed by means of a screw 135.
The endosseous screws 122 are housed in transverse seats 139 between
the two jaws 137 and 138; these seats are created by counterposed concavities
or guiding grooves.
In particular the lower jaw 138 has a lateral edge 140 provided on the
side of a first guiding groove 141 which is placed in proximity to an end
projection 148 of the upper jaw 137 provided with an opposite guiding groove
149.
The lower jaw 138 moreover comprises a central prominence 142 on the
side of a guiding groove 143 which is placed in proximity to a prominence 146
of the upper jaw 137, provided on the side of a counterposed guiding groove
147.
As can be observed in the Figures, the locking screw 135 passes through
the edge 140, the projection 148 and the prominences 142, 146 parallel to the
plane P'. Thanks to this arrangement it is possible, by rotating the locking
screw 135, to regulate the relative position of the two jaws on the plane P',
which allows for the adjustment according to necessity of the dimension of the
transverse seats 139 for the endosseous screws 122 accommodated therein, to
accommodate screws or other tubular fixation elements with different
dimensions, without modifying the reciprocal distance between these.
The main advantage of the main clamp in the latter embodiment lies in
the fact that, as in the previous embodiment, it presents a greater number of
seats for the transverse screws, with dimensions that are generally modest. In
effect the clamping screws and the holes for the insertion of the connection
pins of the compressor, being placed side by side in a line, occupy less space
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on the body of the clamp, which leaves more space for the guiding grooves. In
this manner the clamp according to the present invention has dimensions that
are altogether reduced while at the same time maintaining the same number of
guiding grooves as a clamp known from the prior art.
Also the main clamp of this second embodiment has five transverse
seats, which offer more possibilities in the choice of positioning of the two
endosseous screws, wherein said seats are preferably distributed with a
central
group of at least three seats, and two lateral seats.
A further advantage of the orthopaedic device in accordance with this
second embodiment lies in the fact that it is possible to adjust not only the
position of the endosseous screws on the main clamp, but also to adjust the
position of the endosseous screws supported by the main clamp with respect to
the endosseous screws supported by the auxiliary clamp.
Thanks to the possibility of the angular movement of the connection
appendix in the cylindrical collar, it is in fact possible to adjust the
reciprocal
position of the screws on relative planes, to meet the specific anatomical
needs
of the bone. =
A further advantage lies in the possibility, as mentioned above, to vary
the dimension of the transverse seats of the auxiliary clamp.
Obviously numerous modifications and variations can be applied to the
clamp and the orthopaedic device described above by a person skilled in the
art
to meet contingent needs and specifications, which are in any case contained
within the scope of protection of the invention as defined by the following
claims.
