Source: http://www.docstoc.com/docs/49059237/Spine-Osteosynthesis-Instrumentation-For-An-Anterior-Approach---Patent-5702395
Timestamp: 2015-03-06 06:57:06
Document Index: 317821139

Matched Legal Cases: ['art 41', 'art 42', 'arts 41', 'art 43', 'art 41', 'art 43', 'art 42', 'art 41', 'art 42', 'art 42', 'art 42', 'art 41', 'art 42']

Spine Osteosynthesis Instrumentation For An Anterior Approach - Patent 5702395
49059237
The present invention relates to a spinal osteosynthesis instrumentationfor an anterior approach.In the field of spinal instrumentation, instrumentation for a posterior approach has been widely explored and still remains an interesting solution in many pathological cases.However, this technique has the drawback of not permitting direct access to the vertebral bodies, which often limits the use thereof and encourages an exploration of another approach, such as the anterior approach.Although it is much more delicate and complex than the instrumentation for a posterior approach, the instrumentation for an anterior approach opens up a wider field of investigation. It is becoming necessary to investigate this field despite thefact that this approach requires considerable technical means and environment in the hospital and a specific training of very highly specialized orthopaedic surgery practitioners.Depending on the vertebral level to be reached, several techniques of access by an anterior approach are at present practiced. They are:Transpleural thoracotomy in the thoracic region,Thoraco-phrenolumbotomy in the thoracolumbar region,Lumbotomy in the lumbar region.For each of these techniques, the approach on the left side of the vertebral column is preferred despite the proximity of the aorta, owing to the presence on the right side of the vena cava which is more fragile and less easy to move than theaorta.However, the extension of the large vessels along the vertebral bodies has repercussions on the mounting of an instrumentation.The technique by the anterior approach of the dorsolumbar spine is employed:either for correcting a scoliosis and maintaining its correction,or for treating a kyphosis with a large radius of curvature or an angular kyphosis.Some surgeons are afraid of this technique; however, it is acknowledged to favour the treatment of certain pathologies. It is even indispensable in certain cases.Whatever be the surgical schools of thought formed around s
United States Patent: 5702395
5,702,395
Hopf; Christoph (Mainz, DE)
(Rangdu Fliers,
WO94/10927
606/250  ; 606/265
A61B 17/70&amp;nbsp(20060101); A61B 19/00&amp;nbsp(20060101); A61B 017/70&amp;nbsp()
606/61,53,60,69,70,71,72,73
1.  Spinal osteosynthesis instrumentation for an anterior approach, said instrumentation comprising:
means slidably disposed within said blocks and bearing against said rods for clamping said rods against rotation and translation relative to said blocks;  and
2.  Instrumentation according to claim 1 wherein said anterior part has a thickness less than the thickness of said posterior part and has a rounded edge.
3.  Instrumentation according to claim 1, wherein each block defines two recesses each receiving a respective rod;  and
4.  Instrumentation according to claim 3, wherein each slide is provided with inclined lateral flanges, complementary lateral grooves are provided in the respective recess, said inclined lateral flanges being engageable in said complementary
lateral grooves, inclined clamping ramps are provided in said grooves, said flanges being cooperative with said clamping ramps, said ramps having an angle of inclination of substantially 2.degree.  to 6.degree.  relative to the axis of the respective
5.  Instrumentation according to claim 4, wherein each flange of each slide has an end which is the first to enter the respective recess and is chamfered and said respective recesses has an entrance which is chamfered whereby the insertion of
6.  Instrumentation according to claim 5, wherein each slide bears an indicia indicating a direction of insertion of said slide into a respective longitudinal recess so that said end first enters the recess.
7.  Instrumentation according to claim 5, wherein said block bears indicia indicating a direction of insertion of each slide into a respective longitudinal recess so that said end of each slide first enters the respective recess.
8.  Instrumentation according to claim 4, wherein the inclinations of said lateral flanges of said slides and the inclinations of the associated clamping ramps are inverted between the two slides of each block.
9.  Instrumentation according to claim 4, wherein the inclinations of said ramps and flanges of said slides are oriented in the same direction for the slides of tile same rod and in the opposite direction for the ramps and flanges of tile slides
10.  Instrumentation according to claim 3, comprising semi-cylindrical channels forming seats for said rods provided in the bottom of said recesses of said blocks and in said slides.
11.  Instrumentation according to claim 3, wherein each slide has a surface which is flush with an outer convex surface of the respective block so that said outer convex surface and said surface of each slide are together smooth and devoid of any
12.  Instrumentation according to claim 11, wherein each block comprises complementary clamping means for the respective slide.
13.  Instrumentation according to claim 12, wherein said complementary clamping means comprise, for each slide, a screw insertable in an opening provided in the central part of the respective block between said recesses, said opening
14.  Instrumentation according to claim 13, wherein said clamping screw comprises, from one end to the other thereof, a screw threaded anchoring stem, a conical portion for clamping said slide which tapers toward said screw threaded stem, a
15.  Instrumentation according to claim 12, wherein said complementary clamping means comprise a central aperture in each block, a screw insertable in said central aperture, said aperture and said screw having a sufficient diameter to enable said
16.  Instrumentation according to claim 3, further comprising a cavity in a wall of each recess configured to receive a boring tool therethrough for boring in the vertebral body for inserting an anchorage screw In the vertebral body.
17.  Instrumentation according to claim 1, wherein one rod is an anterior rod and has a diameter less than the diameter of the other rod which is a posterior rod.
18.  Instrumentation, according to claim 1, comprising an opening in an anterior part of each block for receiving a distraction-compression tool.
19.  Spinal osteosynthesis instrumentation for an anterior approach, said instrumentation comprising:
a pair of anchorage screws for each of said blocks;  and
20.  Instrumentation according to claim 19, wherein said pair of anchorage screws are each supported in a respective one of said pair of bores to subtend an angle between said pair of screws for each of said blocks, said angle being substantially
21.  Instrumentation according to claim 19, comprising semi-cylindrical channels forming seats for said rods in said recesses of said blocks and in said slides, each bore opening onto the respective semi-cylindrical channel receiving the
22.  Instrumentation according to claim 19, wherein one of said rods has a first diameter and the other of said rods has a second diameter less than said first diameter.
23.  Spinal osteosynthesis instrumentation for an anterior approach, said instrumentation comprising:
24.  Instrumentation according to claim 23, wherein one of said rods has a first diameter and the other of said rods has a second diameter less than said first diameter.
25.  Instrumentation of claim 23, wherein each of said recesses for each of said blocks defines a bore therethrough configured to received an anchorage screw.
26.  Spinal osteosynthesis instrumentation for engaging at least two elongated rods to the anterior aspect of the spine, comprising:
opposite end of said recess, said slide clamping a rod within said respective longitudinal recess along the travel of said slide;  and
27.  Spinal osteosynthesis instrumentation according to claim 26, wherein:
said block defines an opening between said two recesses, said opening communicating through a lateral passage with at least one of said recesses;  and
28.  Instrumentation of claim 26, wherein one of said recesses is sized to receive one of the rods having a first diameter and other of said recesses is differently sized to receive another of the rods having a second diameter, said second
29.  Spinal osteosynthesis instrumentation for engaging at least two elongated rods to the anterior aspect of the spine, comprising:
30.  Spinal osteosynthesis instrumentation according to claim 29, wherein said at least one lateral groove along each of said recesses defines a clamping ramp inclined relative to said longitudinal axis of said recess, said lateral flange of each
31.  Spinal osteosynthesis instrumentation according to claim 30, wherein said clamping ramp defined in each of said recesses is inclined at substantially 2.degree.-6.degree.  relative to said longitudinal axis of said recess.
32.  Instrumentation of claim 29, wherein one of said recesses is sized to receive one of the rods having a first diameter and other of said recesses is differently sized to receive another of the rods having a second diameter, said second
33.  Spinal osteosynthesis instrumentation for an anterior approach, comprising:
34.  Spinal osteosynthesis instrumentation for engaging the anterior aspect of a patient&#39;s spine, comprising:
a first spinal rod configured for fixation along the patient&#39;s spine;
a second spinal rod configured for fixation along the patient&#39;s spine adjacent to said first rod;
a first slide configured to slidingly engage said first recess to clamp said first rod between said first slide and said block when said first rod is received in said first recess;  and
35.  Spinal osteosynthesis instrumentation according to claim 34, wherein:
said first slide includes a first flange for slidingly engaging said first groove;  and
36.  Spinal osteosynthesis instrumentation according to claim 35, wherein:
37.  Spinal osteosynthesis instrumentation according to claim 34, wherein said first rod has a smaller diameter than said second rod.
38.  Spinal osteosynthesis instrumentation according to claim 34, wherein said block defines a first bore intersecting said first recess and further comprising a first anchorage screw inserted through said first bore.
39.  Spinal osteosynthesis instrumentation according to claim 38, wherein said block defines a second bore intersecting said second recess and further comprising a second anchorage screw inserted through said second bore, said first and second
40.  Spinal osteosynthesis instrumentation according to claim 34, wherein:
said block defines an opening between said first and second recesses, said opening communicating through a lateral passage with at least one of said first and second recesses;  and
at least one of said first and second slides when disposed within a corresponding one of said first and second recesses.  Description
The present invention relates to a spinal osteosynthesis instrumentation
Although it is much more delicate and complex than the instrumentation for a posterior approach, the instrumentation for an anterior approach opens up a wider field of investigation.  It is becoming necessary to investigate this field despite the
Depending on the vertebral level to be reached, several techniques of access by an anterior approach are at present practiced.  They are:
Some surgeons are afraid of this technique; however, it is acknowledged to favour the treatment of certain pathologies.  It is even indispensable in certain cases.
French patent 2651992 (8912187, inventor J. M. LAURAIN) proposes the use of a rigid plate.  Such a device corresponds to the specific requirements of fractures and tumors and of the degenerative field, but is hardly suitable for vertebral
In particular, the large number of parts making up the instrumentation implies a relatively long operating time and consequently this instrumentation, although effective, is costly, which hinders its extension and marketing.  In brief, the
posterior part and being capable of being inserted in a recess provided for this purpose in the vertebral body.
Further features and advantages of the invention will be apparent from the following description with reference to the accompanying
The spinal osteosynthesis instrumentation for an anterior approach shown in FIGS.
1 to 7 comprises at least two blocks 1 adapted to transversely interconnect two rigid rods 2, 3 which are parallel to each other and axially slidable in said blocks.  The instrumentation is shown in the vertical position viewed on the left side of the
spine.  The blocks 1 are provided with means for clamping the rods 2, 3 against rotation and translation and comprising essentially, for each block 1, 2, two slides 4, 5 movable in translation in a direction parallel to the rods 2, 3 in corresponding
Each block 1, 2 is also provided with a pair of bone anchorage screws 8, 10 which may be placed in position by inserting them in corresponding bores 9, 11 provided in the bottom of the recesses 6 and 7.  The bores 9, 11, and therefore the screws
and corresponding to the antero-lateral anatomy of the vertebral bodies.  Thus, this outer surface has a substantially convex shape from the anterior surface S1 to the posterior surface S2, while the interior surface S3, adapted to be applied against the
Each block 1, 2 has a substantially rectangular general shape of which the anterior region has a thickness less than that of the posterior region and the edges 12, 12a are rounded.  Correspondingly, the radius of curvature of the anterior surface
The upper surface (S2, S1) of each block is smooth owing to the fact that the surface of the slides 4, 5 are flush with the surrounding surface of the block, thereby avoiding any projection.  The two recesses 6 and 7 extend in a direction
parallel to each other and are each adapted to receive a portion of the respective rod 2, 3: the posterior rod 2 has a diameter distinctly larger than that of the rod 3 for a reason which will be explained hereinafter.  The whole of the device must be
Arranged in the bottom of each recess 6, 7 is a semi-cylindrical channel 13, 14 whose diameter corresponds to that of the respective rod 2, 3.  Further, two lateral grooves 15a, 16a and 15b, 16b are formed in the sides of each recess 6, 7 in
parallel relationship.  These lateral grooves are adapted to receive corresponding lateral flanges 17, 18, 19, 20 of the respective slides 4 and 5.  The flanges 17, 18, on one hand, and 19, 20, on the other, are arranged in a substantially different
manner, as can be seen in FIGS. 5 to 7, owing to the dissymmetry between the posterior and anterior parts of each block 1.  Consequently, the same is true of their corresponding grooves (15a, 16a, 15b, 16b).
The flanges 17, 18 and 19, 20 are inclined at a suitable angle A (FIG. 2) on the bottom of the recesses 6, 7 in the same way as their respective lateral grooves 15a .  . . 16b which have for this purpose ramps of the same inclination A as the
flanges 17 .  . . 20.  Thus the progressive insertion of each slide 4, 5 in the corresponding recess 6, 7 in the direction of the arrows (FIGS. 1 and 4) results in a progressive gripping of the flanges 17, 18 and 19, 20 in their grooves 15a, 16a .  . .
and finally the clamping of the slides in the recesses 6, 7.  The inclinations of the flanges (17 .  . . 20) are inverted on the slides 4 and 5 so that the latter are inserted in the recesses 6, 7 in opposite directions indicated by the arrows (FIGS. 1
and 4) to obtain a technical result which will be explained hereinafter.  The angle of inclination A of the flanges 17, 18 and 19, 20 and of the ramps may be between about 2.degree.  and 6.degree..
The entry ends of the flanges (19 .  . . 20) are advantageously machined in such manner as to have chamfers or rounded edges, such as 17a (FIG. 2).  Correspondingly, the entry edges of the recesses 6, 7 also have chamfers not, shown in FIGS. 1 to
7 but shown in FIGS. 8 to 12 (50, 51).  In cooperation with the chamfers 17a, these chamfers facilitate the insertion of the slides 4, 5 in their recesses 6, 7.
Each block 1 can include complementary clamping means for each slide 4, 5.  In the illustrated embodiment, these clamping means comprise, for each slide 4, 5, a respective screw 23, 24 which can be inserted in an opening 25, 26 provided in the
central part of the block 1 between the recesses 6, 7.  The opening 25 for the screw 23 communicates through a lateral passage 27 (FIG. 5) with the adjacent groove 16b of the lateral flange 19 of the slide 5.  Likewise, the opening 27 of the passage
between the opening 26 for the screw 24 and the groove 16a of the flange 18 of the slide 4 is shown in FIG. 5.  Each screw 23, 24 has, from one end to the other, a screw threaded bone anchorage stem 28, a conical portion 29 which tapers toward the screw
The end of the screw threaded portion 28 is rounded and is substantially flush with the interior surface S3 of the block 1.  This screw threaded portion 28 is so dimensioned, as is the conical portion 29, that the latter bears against the
An aperture 34 is provided in the anterior part of each block in the surface S1 between the recess 7 and the rounded edge 12.  This aperture 34 is adapted to receive the rounded head 35 of a distraction-compression tool 36 (FIG. 13) which is
The implantation of the block 1 or &quot;clip-block&quot; requires the use of specific ancillary devices:
The posterior rod 2 may have a diameter of 4 to 7 mm while the anterior rod 3 has a smaller diameter of 3 to 6 mm.  This difference between the diameters is explained by the fact that it is on the posterior rod 2 that the main forces are exerted,
in particular those due to derotation.  On the other hand, the anterior rod 3 is subjected to smaller mechanical forces and may consequently have a smaller diameter.  Further, this anterior rod 3 is the closest to the large blood vessels so that its
reduced diameter increases the surgical safety of the instrumentation.  However, this difference in diameter is not obligatory and the two rods 2 and 3 may possibly have the same diameter.
FIG. 14 shows an embodiment of the instrumentation according to the invention constituting a short arrangement extending along a vertebral segment of three vertebrae L3, L2, L1.  The sequence of the mounting of the component parts of this
A block 1 is placed on and then secured to the anterolateral side of the body of the vertebra L3 by means of vertebral screws 8, 10.  Another block 1 is also placed in position and then secured in the same way to the body of the vertebra L1, the
A posterior rod 2, for example having a diameter of 6 mm, is placed in the posterior recesses 6 in the upper block and lower block.  By means of a suitable ancillary device, the posterior slides 4 corresponding to the recesses 6 are installed on
their respective inclined ramps 6a, 7a and are placed in contact with the upper side of the rod 2.  This rod is thus trapped in the recesses 6 of the blocks but remains movable in translation and rotation under the action of outside forces.  This is why
the position of the slides on their clamping ramps, or intermediate position, must be such as to permit acting in complete safety on the rod without allowing the latter to escape from its recess.  The slides are consequently not pushed to the end of
Such an intermediate position of the slides enables the surgeon to effect if necessary a derotation action on the vertebral column by revolving the posterior rod 2 about itself.  Corresponding to this derotation is a new position of the rod 2
Then an anterior rod 3, for example having a diameter of 4 mm, of the same length as the posterior rod 2 in the embodiment shown in FIG. 14 (no slides are shown), is inserted in the anterior recesses 7 of the upper block and lower block.  As for
the rod 2 and the slides 4 of the recesses 6, the anterior slides 5 are placed on their respective inclined ramps in such manner as to maintain the rod 3 in a trapped position but sufficiently free to move in particular in translation.  Their gripping
As soon as the slides 4, 5 are fully clamped, the installation of the instrumentation is finished.  Owing to the constitution of the blocks according to the invention, the rectangulation or framing effect of the appliance, similar to that
As concerns the constitution of the instrumentation according to the invention, it is important to notice the reliability of the device, in particular in the anchorage of the blocks 1 to the vertebrae.  The anchorage screws 8, 10 are indeed
detached from the vertebral column in which they are inserted.  Their axial displacement is rendered impossible so that, in the event of a possible fracture in any region of its length, the two screw portions are held fast and nonetheless maintain the
4, 5.  In this way, as the inclined ramps of the recesses 6, 7 are arranged to permit such an inverted insertion of the slides of each block 1, after the slides are clamped in position, all the forces exerted by the multiple movements of the patient on
one of the rods which tend to untighten the assembly are taken by the other rod in the opposite direction for exerting gripping forces.  They are in this way neutralized, this arrangement therefore considerably increasing the reliability of the whole of
First of all, the rectangular structure obtained by the assembly of two clip-blocks 1 with their slides 4, 5 and the two rods 2, 3, constitutes a device for the fixation and the rectangulation of the assembly providing an improved stabilization.
In instrumentations of the prior art having rods, it was necessary for the two rods to be definitively fixed for placing in position a transverse connection device (rectangulation).  Owing to the present invention, the rectangulation of the device is
Small volume not only as concerns thickness so as to avoid contact with the large vessels, but also as concerns the amount of metal employed.  For example, this thickness should not exceed 11 mm in the posterior third of the vertebral body and 9
mm in the middle third.  This avoids any interference with the consolidation of the bone graft.
Simplicity of positioning by the surgeon, owing to the small number of component parts making up the instrumentation.  This reduces the number of ancillary devices required and consequently the overall cost of the instrumentation.
Considerable safety of utilization owing to the fact, in addition to the foregoing features, that each anchorage screw 8, 10, once inserted in its bore 9, rests therein in a completely trapped manner.  Indeed, the cylindrical rod 2, 3 is clamped
on the head of the screw 8, 10 by the corresponding slide 5, 4 after the complete closure of the latter.  Consequently, the screw is completely blocked in the axial direction and, if a transverse fracture of its screw threaded portion occurs, its
The force exerted for completely closing the slides 4, 5 is sufficiently high to prevent the accidental opening of the latter owing to the action of each longitudinal flange (17 .  . . 20) and its chamfered end 17a which permits a privileged
insertion in one direction rather than in the other (see FIGS. 1 and 4).  This is the reason for the provision of arrows on the surface of the slides 4 and 5 which indicate the direction of insertion of each slide.  This arrangement is made necessary by
The upper surface of each clip-block 1 is completely smooth, in particular in its most rounded lateral part S1 corresponding to the anterior positioning on the vertebrae.  The upper surface of the slides 4, 5 which is also smooth is flush with
the surfaces S1, S2 of the lateral parts and of the central part of the block 1, so that no particular element projects.  This is a notable advantage of the clip-block provided by the invention.
The screws 23, 24 clamping the slides 4 and 5 afford additional safety to the instrumentation by the tightening of their conical portions 29 on the flanges 18 and 19 of the slides 4, 5.  It concerns an additional safety means with respect to the
clamping of the slides 4, 5 on the rods C-D 2 and 3, since the clamping is in any case assured by the clamping of the slides on the rods.  The screws 23, 24 therefore only have an additional subsidiary effect.  In order to avoid projecting from the
surface of the block 1, each screw 23, 24 is broken off in its upper part after tightening on the block, with the aid of the fracture conical portion 31.  This fracture therefore occurs at the junction between the fracture conical portions 31 and the
tightening conical portions 29, in the weakest region.  Thus each screw 23, 24 is practically hidden in the block 1 since the fracture plane is approximately at a distance of 2 to 3 mm from the surface S2 of the block 1.
In the second embodiment of the invention shown in FIGS. 8 to 13, each block 40 has a generally bent shape so as to have an approximately S-shaped cross-section.  The two halves 41 and 42 of the block 40 respectively constitute its posterior and
anterior parts, the posterior part 41 having a thickness e1 greater than the thickness e2 of the anterior part 42.  The two parts 41, 42 are interconnected by a central part 43 which extends in a general direction P substantially perpendicular to the
plane P1 of the bottom of the recess 44 of the posterior part 41.  On the other hand, the general direction P in which the central part 43 extends makes an angle B of less than 90.degree.  with the plane P2 of one of the sides of the bottom of the recess
45 of the anterior part 42.  As in the blocks 1, semi-cylindrical channels 46, 47 are provided in the bottom of the respective recesses 44, 45 and complementary channels 46a, 47a in the slides 4, 5, the diameters of said channels corresponding to those
of the rods 2 and 3.  Bores 48, 49 are provided in the bottom of the channels 46, 47 for receiving anchorage screws 10 and 8 respectively.  Note that in FIGS. 8 and 9 the entry chamfers 50, 51 of the recesses 44 and 45 facilitate the insertion of the
corresponding slides 4, 5.  Further, the arrangement of the block 40 is similar to that of the block 1, the same reference numerals being used for the corresponding parts in both cases.
When the component parts of this instrumentation have been assembled (FIGS. 11 and 12), the anchorage screws 10 and 8 respectively extend through the posterior part 41 and anterior part 42 and make an angle therebetween on the order of 35.degree. to 40.degree..  The anterior part 42 is then placed in a vertebral recess 52 (FIG. 13) produced by the surgeon and opening onto the anterior part of the vertebra, for example L3 or L1.  Thus the anterior part 42 of the clip-block 40 is inserted in the
vertebral region.  The angle between the posterior part 41 and anterior part 42 (corresponding to the angle between the two planes P1 and P2) affords additional safety to the surgeon bearing in mind the proximity of the large vessels in the anterior
The edge 12 of the anterior part S1, which is slightly rounded in the transverse direction as already mentioned, may have a radius of curvature of about 15 mm.  This specific shape corresponds to the mean estimation of the value of the concavity
of the vertebra in the region of the implantation of the block 1, 40 on the latter.  This disposition contributes to the obtainment of the desired stability of the whole of the instrumentation owing to the fact that there is in this way an improved
slides 4 clamping the posterior rod 2 (which is used for the derotation), can be opposed or balanced by the forces tending to loosen the slide or slides 5 clamping the anterior rod 2.  Experience has shown that it is desirable to clamp the slides 4 on
Such an assembly has an excellent mechanical behaviour.  In strength tests with a static and dynamic testing machine, employing the maximum forces normally produced by the human body, it was not possible to detect a loss of connection.
It must be understood that the scope of the invention is not intended to be limited to the two described embodiments since many alternative embodiments may be envisaged.  For vertebral segments longer than that illustrated in FIG. 14, the
Likewise, it could be necessary that, as opposed to the embodiment shown in FIG. 14, the two rods 2 and 3 be exceptionally different, for example that the posterior rod 2 extend beyond the anterior rod 3.  In this case, the rods may be fixed as
previously described, and the extending portion of the rod may be fixed by at least one clip-block according to the invention but defining a single recess 6 or 7.  This block is then fixed so as to maintain the additional length of this rod, the recess
The additional means for clamping the slides 4, 5 constituted by the pairs of screws 23, 24 may comprise only a single screw per block 1, which may be inserted in a central aperture in the block.  This aperture and the screw then have a diameter
which is sufficient to ensure that the aperture communicates through lateral passages with the adjacent grooves (16a, 16b) of the lateral flanges 18, 19 of the slides 4, 5.  The screw is provided with a conical portion 29 positioned to engage in said
"Spine Osteosynthesis Instrumentation For An Anterior Approach - Patent 5702395"
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