CA2113112C - Spinal fixation system - Google Patents
Spinal fixation systemInfo
- Publication number
- CA2113112C CA2113112C CA002113112A CA2113112A CA2113112C CA 2113112 C CA2113112 C CA 2113112C CA 002113112 A CA002113112 A CA 002113112A CA 2113112 A CA2113112 A CA 2113112A CA 2113112 C CA2113112 C CA 2113112C
- Authority
- CA
- Canada
- Prior art keywords
- plate
- slot
- arcuate surface
- concave depressions
- pedicle screw
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
- A61F5/01—Orthopaedic devices, e.g. splints, casts or braces
- A61F5/04—Devices for stretching or reducing fractured limbs; Devices for distractions; Splints
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7059—Cortical plates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
- A61B17/7002—Longitudinal elements, e.g. rods
- A61B17/7004—Longitudinal elements, e.g. rods with a cross-section which varies along its length
- A61B17/7007—Parts of the longitudinal elements, e.g. their ends, being specially adapted to fit around the screw or hook heads
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
- A61B17/7002—Longitudinal elements, e.g. rods
- A61B17/701—Longitudinal elements with a non-circular, e.g. rectangular, cross-section
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
- A61B17/86—Pins or screws or threaded wires; nuts therefor
Abstract
A spinal fixation system comprises an elongated fixation plate (13) having an elongated slot (21) with a number of concave depressions (28, 25) formed at the top and bottom surfaces (19, 17) of the plate. The system further includes a pedicle screw (40) and a nut (32) for load transmission between a vertebra and the plate. The pedicle screw includes a threaded nut engaging portion (42), a threaded bone engaging portion (44) and an intermediate portion (46) therebetween which has rigid upper and lower arcu-ate surfaces (47) that are complementary to the concave depressions in the plate. The nut also includes a rigid lower arcuate sur-face (36) which is complementary to the upper concave depressions of the plate. In one assembled configuration the plate is clamped between the upper arcuate surface of the pedicle screw and the nut. In an alternative embodiment of the pedicle screw (70), the intermediate portion has an upper and lower arcuate surface (79, 77) of different spherical radii of curvature.
Description
2 PCI/US92/0!~905 SPINAL FIXATION SYSTEM
2~ 13~ 12 BACKGROUl;l ~ OF THE I NVENT I ON
The present invention relates to spinal fixation methods 10 and systems. In particular, the invention concerns a fixation plate and bone screw sys~em for attachment to vertebral bodies to hold the vertebrae in alignment.
Within the last few decades, spinal fixation systems have been developed using generally rigid plates whicll are engaged 15 between vertebrae of the spine, typically on opposite sides of the spinous processes. One such type of spinal plate is illustrated in the patents to Stelfee, U.S. Patent Nos.
4,611,581 and ~1,696,290. In this devic~, a spinal plate is provided which has a series of openings therein for receiving 20 the threaded portions of force transmitting members. The force transmitting members comprise a dual-threaded screw which includes a first threaded portion for engaging the bone of the vertebrae, and a second threaded portion which projects outwardly from the vertebrae and through the 25 openings in the spinal pla~ e. The dual-threaded bone screws in the Steffee apparatus are engaged to the bone plate by way of a nut which is tightened onto the second threaded portion of the force transmitting members and against the plate. The spinal plate described in the Steffee references includes a 30 number of bridge elements between the elongated openings in the plate which tend to increase the rigidity of the plate.
WO 93/01772 PCr/US92/0~905 -2- 21~3~12 ~
Another type of spinal fixation system is shown in t~1e patent to~Luque, U.S. Patent No. 4,790,297, which has been assigned to the assignee of the present invention. In thi~
system, a spinal fixation plate includes a single elongated 5 opening which extends substantially across the length of the plate. A number of depressions are formed in the top surface of the plate at the edge of the çentral elongated opening.
These depressions are used to engage a convex portion of a bone screw which extends through the opening in the bone o plate and into the vertebral bone. The system also includes a plate ring which encircles the plate to prevent the plate from spreading when the bone screws are tightened down onto the bone plate. The plate ring can be situated at any position along the length of the fixation plate.
One difficulty encountered by prior plating fixation systems is the failure of the pedicle screw. For instance, with the Steffee system, the first threaded portion ~or bone screw portion) includes a nut surface which contacts the bottom face of the fixation plate when the separate nut is 20 tightened against the top face of t11e plate. In practice it has been found that the nut surface does not contact flush against the bottom face of the fixation plate, thereby leaving an unsupported sectior1 of the second threaded or nut engagement portion exposed beneath the plate. This results 2s in stress risers in the second threaded portion which are susceptible to fatigue failure under the cyclic loads generated by spinal motion. An increase in the angular deviation or angulation of the screw to the fixation plate in the Steffee system may increase the stresses and the 30 likelihood of fatigue failure. ~ ~
Another related disadvantage of some of the prior s~inal fixation systems using a generally rigid bone plate is that the plates do not per1nit a beneficial amount of angulation between the bone screws and the plate, which may be reguired 35 to account for various angles of fixation to the vertebrae or WO 93/01772 PCr/US92/05905 ' 2113~12 to accommodate normal sagittal curvature of the spine. In these prior devices, this angulation is often provided by bending the bone plate itself to conform to curvature between adjacent vertebrae. ~e~,ding the plate presents difficulty in 5 properly aligning the pedicle screw with the vertebrae.
Optimally, in plate spinal fixation systems, a compromise in stiffness and rigidity of the system is required so that the system is stiff enough to challenge the bone to facilitate bone fusion cf the spine, and not so rigid that 10 normal loads on the spine will lead to fatigue failures of the bone screws. Present fixation systems do not appear capable of achieving this compromise.
There is therefore a need for a spinal fixation system which can more easily ccmpromise the rigidity needs for bone 15 growth and for protection of the fixation system components.
In other words, the need exists for a fixation system that has increased stiffness characteristics without the accompanying tendency for fatigue failures.
There is also a need for a spinal f ixation system that is 20 capable of achieving angulation between the bone-engaging screws without the necessity of bending and forming the bone plate itself. A further need exists for a spinal fixation system in which the load transmitted from the vertebral bone to the force transmitting member can be transmitted to the 25 fixation plate at an angle other than generally perpendicular to the plate surface.
WO 93/01772 PCr/US92/05905 ~113112 4_ ~
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. l is a pictorial plan view of a portion of a patient's spinal column with a pair of the spinal fixation systems according to the present invention secured thereto.
FIG. 2 is a perspective view of the fixation plate means of tlle spinal fixation system of the present invention.
FIG . 3 is a cross-sectional view of the f ixation plate means in FIG. 2 taken along line 3-3 as viewed in the direction of the arrows.
FIG. 4 is an exploded side elevation view of the load transmitting means of the spinal fixation system of the present invention, FIG. 5 is an end view of the pedicle screw means of the load transmitting means shown in FIG. 4 taken along line 5-5 15 as viewed in the direction of the arrows.
FIG. 6 is an enlarged sectional view of a vertebrae with the spinal fixation system attached thereto, taken along 6-6 in FIG. l as viewed in the direction of the arrows.
FIG. 7 is a side schematic representation of the spinal 20 fixation systeln of the present invention showing a pair of load transmitting means at different relative angles to each other .
FIG. 8 is a side elevational representation of the load transmitting means of an alternative embodiment of the spinal 25 f ixation system of the present invention .
FIG. 9 is a bottom elevation view of an alternative embodiment of a fixation plate means for use with the spinal fixation system of the present invention.
FIG. l0 is a side elevation view of the load transmitting 30 means of another embodiment of the spinal fixation system of the present ir1vention.
FIG. ll is an enlarged sectional view of a vertebrae similar to the view of FIG. 6 with the load transmitting means of FIG. l0 engaged between the vertebra and a fixation 35 plate identical to the plate shown in FIG. 6.
_ _ _ _ _ _ _ _ _ _ _ , . .. . . . .. .. . .. . . ..
~5~ ~113112 SUMMARY OF THE INVENTION
T}le present invention provides a spinal fixation syste which addresses the problems encountered by prior such systems. According to one embodiment of the invention, the 5 system comprises an elongated plate having a bottom side for facing the vertebrae an~ an opposite top side extending generally parallel to the bottom side. The plate further includes an elongated slot defi11ed therethrough between the bottom side and the top side which extends substantially 10 along the length of the plate. The slot has a lower edge at t}1e intersection of the slot and the bottom surface and an upper edge at the intersection of the slot and the top surface. A number of first concave depressions are formed at the lower edge of the slot and a number of second concave 15 depressions are formed ~t the upper edge of the slot. In one embodiment, the concave depressions at the upper edge of the slot form a scalloped surface. The lower edge depressions may also form a comparable scalloped surface corresponding to the upper scallops. In another embodiment, the number of 20 first concave depressior,s at the slot lower edge is a single concave surface extendinlg around the en~ire perimeter of the lower edge of the slot.
The system further comprises load transmitting means for engagement between the vertebrae and the elongated plate for 25 transmitting forces therebetween. This load transmitting means includes pedicle screw means having a first threaded portion, a second threaded portion and an intermediate portion between with the first and the second threaded portions. The second th,readed portion includes a number of 30 threads adapted to engage the bone of the vertebrae. The intermediate portion ha~ a rigid upper arcuate surface facing toward the first thread~d portion, w~1ich upper arcuate surface is substantially complementary to the number of first concave depressions in the fixation plate to be received WO 93/01772 PCr/US92/05905 2~13112 ~ i --6--therein. The load transmitting means also includes a nut having a threaded head portion for engaging the first threaded portion of the pedicle screw means and a rigid lower arcuate surface. The lower arcuate surface is substantially 5 complementary to the number of second concave depressions at the upper edge of the slot to he received therein.
In the assembled configuration of the spinal fixation system, the pedicle scre~ means is threaded into the vertebra wit11 the first threaded portion extending outward. The 10 f ixation plate is supported by the intermediate portion of the pedicle screw means, and particularly against the ~1pper arcuate surface. The nut is tightened down along the first threaded portion until it clamps the fixation plate between the intermediate portion of the pedicle screw means and the nut. The lower arcuate surface of the nut is received within an upper concave depression while the upper arcuate surface of the pedicle screw means is received within a lower concave depression .
In an alternative assembled configuration, the pedicle screw means is threaded into the vertebra with the lower arcuate surface of the intermediate portion situated in an upper concave depression of the plate. The pedicle screw means is extended through the plate slot and threaded directly into the vertebra through the plate slot until the irltermediate portion pulls the plate adjacent or into contact with the vertebra. The first threaded portion of the pedicle screw means can be removed once the screw means has been threaded into the bone. It is clear that the sa1ne pedicle screw means can be engaged in the vertebra as a bone screw or a bone bolt, depending upon the degree of fixation and rigidity required at t}1e location of the pedicle screw means. In one specific embodiment of the pedicle screw means, the intermediate portion is configured to readily accept either assembled configuration.
In one aspect of the invention, the first and second WO 93/01772 PCr/US92/05905 ~3~
concave depressions and the upper and lower arcuate surfaces coact to permit angulation of the pedicle screw means relative to the elongated plate. The arcuate surfaces and concave depressions maintain in load transmitting contact 5 over a wide range of angles 50 that forces generated by motion of the spinal c~1~mn are efficiently transmitted to the fixation plate even when the pedicle screw means are at an angle to the pl_'e.
It is one object of the plate spinal fixation system of 10 the present invention to achieve an optimum compromise in stiffness and rigidity of the system so that the system is stiff enough to challenge the bone to facilitate bone fusion of the spine, and not so rigid that normal loads on the spine will lead to fatigue failures of the bone screws. Another 15 object i5 to provide a spinal f i~ation system that is capable of achieving angulation between the bone-engaging screws without the necessity of bending and forming the bone plate i tself .
A further object resides in a spinal fixation system in 20 which the load transmitted from the Yertebral bone to the load transmitting member can be efficiently transmitted to the fixation plate at an angle other than generally perpendicular to the plate surface. A related object is to permit load transmission at angles to the fixation plate 25 without creating stress risers or concentrations in the force transmitting member.
Still another object contemplated by the invention is to provide a load transmission member and spinal plate construct that can accommodate different configurations to achieve 30 different de~rees of fixation and rigidity. Other objects, as well as certain benefits, of the present invention will become apparent from the following written description and accompanying f igures .
WO93/01772 ~ t PCr/US92/05905 21~3112 ff DESCRIPTION OF THE PREFERRE~ EMBODIMENT
For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the embodiment illustrated in the drawings and specific 5 language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated device, and such further applications of the principles of the invention as 10 illustrated therein being contemplated as would normally occur to one skilled in the art to which the invention relates .
In a preferred embodiment of the invention, a spinal fixation system 11 is depicted in FIG. 1 which is used for 15 segmental fixation of the vertebrae V of a spinal column.
The spinal fixation system 11 comprises, in general, a substantially rigid spinal plate means or plate 13 and at least a pair of load transmitting means 15. Typically, a fixation system 11 is utilized on each side of the spinal 20 column or spinous processes, as shown in FIG. 1, and may be used to fix a plurality of levels of the spinal column, as will be apparent to those skilled in the art. The load transmitting means 15 are engaged with the vertebrae and operate to transmit forces from the spinal column to the 25 fixation plate means 13.
Plate ring means or plate ring 23 is provided with the spinal fixation system 11 which at least substantially encircles the fixation plate means 13 (see also FIG. 6). The construction and object of the plate ring 23 of the present 30 invention is substantially as shown and described in the commonly owned patent to Luque, U.S. Patent No. 4,790,297.
(For instance, see column 4, lines 1-12 of the subject patent. ) For purposes of the present invention, the plate ring 23 encircles the fixation plate 13 to prevent the plate WO 93/01772 PCI~US9~/05905 211311~
g 13 from spreading when the load transmitting means 15 are tightened or snugged do~n onto the plate 13. The plate ring 23 can comprise a substantially rectangular body having a substantially rectangular slot therethrough for allowing the 5 plate ring 23 to slide over the plate 13.
Referring to FIGS. 2 and 3, the fi~ation plate means or plate 13 is illustrated as having a first or bottom side 17 and an opposite second or top side 19. The bottom side 17 is directed toward the vertebrae V when the spinal fixation 10 system 11 is in its operative position, while the top side 19 is directed away from the vertebrae. The plate 13 has an elongated slot 21 extending between the bottom and top sides 17 and 19 substantially along the longitudinal length or a2~is of the plate 13. The lc~wer edge of the slot 21 adjacent the 15 bottom side 17 of the plate includes a plurality of lower concave depressions 25. Similarly, ti~e upper edge of the slot 21 adjacent the top side 19 of the plate includes a comparable plurality of upper concave depressions 28. At the bottom side of the plate 17, a pair of opposite lower end 20 depressions 26 are formed at the end of slot 21. A
comparable pair of upper end depressions 29 are situated at the ends of the elongated slot 21 at the top side 19 of the plate 13.
Concave depressions 25 and 28 are preferably positioned 25 completely around all sides of the slot 21 at the bottom and top sides of the plate in a spaced side-by-side relationship. The concave depressions 25 or 28 at either side 17 or 19 of the plate are aligned on opposite sides of the slot 21. Moreover, t~le depressions 25 on tlle bottom side 30 17 are aligned with the depressions 28 on the bottom side 19. The plate 13 thus appears as a "double-scalloped" plate, with a scalloped upper surface and a scalloped lower surface.
The plate 13 may be constructed in various manners. For instance, the slot and depressions may be machined out of a 35 stainless steel bar of various lengths from 1 to 4 inches.
WO 93/01772 PCr/US92/05905 2113~ :~2 ~
The de~ressiorls 25, 26, 28 and 29 are preferably formed by spherical cuts in the bar, having, in one specif ic embodiment, a diameter of 0.315 inches.
The load transmitting means 15, shown in detail in FIG.
5 4, includes a spherical nut 32 and pedicle screw means 40.
The nut 32 includes a head portion 34, which is preferably config~lred as a hex head for engagement by a tightening tool, such as a wrench. The nut 32 further includes a lower arcuate surface 36 which is disposed wit~lin the upper concave 10 depressions 28 or upper end depressions 29 at the top side 19 of the plate 13 when the fixation system is in its operative position. Thus, the diameter of the lower arcuate surface 36 is preferably equal to the diameter of the upper depressions 28 and 29. The spherical nut 32 includes internal female 15 threads for engaging the pedicle screw means 40 of the load transmitting means 15.
The pedicle screw means 40 includes an elongated shaft having a first threaded portion 42 and a second threaded portion 44 . The f i rst threaded portion 4~ includes a number 20 of male threads which are adapted to engage the internal threads 38 of the spherical nut 32. The second threaded portion 44 is configured into a bone helix with a substantially blunt end 45. The threads of the bone helix are adapted to engage the bone tissue of the vertebrae V into 25 which the pedicle screw means 40 is threaded. The configuration of the bone helix of the second threaded portion 44 can be constructed in various manners and in various sizes known to those skilled in the art.
The shaft of the pedicle screw means 40 also includes an 30 integral intermediate portion 46 between the first threaded portion 42 and the second threaded portion 44, so that the pedicle screw means 40 defines a dual-threaded bone screw.
In one embodiment, the intermediate portion includes an upper arcuate surface 47. The upper arcuate surface 47 is adapted 35 to engage the lower concave depressions 25 and 26 in the WO 93/01772 PCr/US92/0590~
~ 3~2 bottom side 17 of the ~late 13. The diameter of the upper arcuate surface 47 is preferably spherical in configuration and has a diameter at least equal to the diameter of tile lower concave depressions 25 and 26. In the illustrated 5 embodiment, the intermediate portion 46 is shown as substantially spherical. However, it is understood that t~le intermediate portion 46 may be truncated leavirlg only the upper arcuate surf ace 47 .
The pedicle screw means 40 is provided with a cavity 49 10 formed in the end of the pedicle screw means adjacent the first threaded portion 42. Preferably, the caYity 49 is hexagonal in configuration for engaging an insertion tool.
The pedicle screw means 40 may also be cannulated to include a bore 48 extending tllrough the entire length of the screw 15 means.
To insert the pedicle screw means 40 into the vertebrae, the preferred spinal fixation method calls for tapping the vertebrae V using a scr~ew tap as is known in the art. Tapped threads can be made in each o~ the levels oF the spinal 20 column to which the spinal fixation system 11 is to be fixed. For instance, as shown in FIG. 1, threads are tapped into three vertebrae V. The pedicle screw means 40 can then be threaded into the tapped bone opening by usirlg a suitable driving too engaged witlhin the hex cavity 49 at the end of 25 the pedicle screw means 40. A guide wire temporarily inserted into the bone can be used to properly align the pedicle screw means as it is threaded into the bone opening, in which instance the guide wire extends through the bore 48.
The pedicle screw m~ans 40 is preferably threaded illtO
30 the bone to a predetermined depth that is ascertained so that the upper arcuate surface 47 can contact the lower concave depressions 25 of the fixation plate means while the fixation plate 13 is situated between processes of the vertebrae V, as shown in FIG. 6. Thus, as shown in FIG. 6, the intermediate 35 portion 46 of the pedicle screw means 40 does not contact the vertebra .
WO 93/01772 2 1 1 3 1 1 2 PCr/US92/0590s Once a pedicle screw means 40 has been threaded into each of the tapped openings in the vertebrae V, t~le fixation plate 13 can be placed against the arcuate surfaces 47 of each of the pedicle screw mearls 40. It is understood that the lower 5 concave depressions 25 and the upper arcuate surfaces 47 of each of the pedicle screw means 40 coact to pernlit angulatio between the pedicle screw means and the fi~ation plate means. In other words, the pedicle screw means is permitted to fit t~le plate 13 at several angles to accommodate abnormal l0 pedicle conditions . Once the f ixation plate has been properly aligned and situated with concave depressions 25 contacting the upper arcuate surf aces 47 of pedicle screw means 40, a spherical nut 32 can be engaged onto the first threaded portion 42 of each of the pedicle screw means.
The spherical nut 32 is then tightened down along the first threaded portion 42 until the lower arcuate surface 36 of the nut 32 engages the upper concave depressions 28 of the ixation plate 13. Again, the lower spherical surface 36 of the nut 32 and the upper concave depressions 28 coact to 20 allow the pedicle screw means 40 to fit the plate 13 at various angles. Moreover, the lower spherical surface 36 and upper concave depressions 28 provide means for aligning the pedicle screw means 40 along the length of the fi~ation plate 13. The coaction of these two surfaces prevents the pedicle 25 screw means from migrating along the length of the plate under loading from the spinal column.
As shown in FIG. 7, a pair of pedicle screw means 40 can be engaged within Yertebrae, not shown in the figure, at differing angles. The leftmost pedicle screw means 40 is 30 shown situated at an angle "A" relative to a perpendicular to the plate 13, while the right-most pedicle screw means g0 is oriented perpendicular to the plate. Unlike prior spinal fixation systems, the present embodiment of the invention provides spherical contacts at the top and bottom sides of 35 the fixation plate between the fixation plate 13 and the load WO 93/01772 PCI`~US92/0590~
~13~1~
transmitting means 15. These spherical contacts permit angulation between the ~-omponents when the spina~ f ixation system is installed in ,~ patient. Moreover, the spherical contacts allow the load from the spinal column passing 5 through the vertebrae V to the load transmitting means 15 to be more efficiently trallsmitted to the fixation plate 13 even when the pedicle screw means is at an angle "A" as depicted in FIG. 7.
The combination of the f ixation plate means 13 and the 10 load transmitting means 15 of the present invention provides a beneficial compromise between the need to control the loads exerted upon the pedicle screw means 40 and the need to challenge the bone tisslle to facilitate bone fusion. As a further advantage, the ~ingle slot 21 of the plate means 13 15 within w}lich the load t]~ansmitting means 15 react allows a spring action in the pl~te as the plate 13 spreads under increasing loads. The coaction between the arcuate surfaces of the fixation plate alld the load transmitting means particularly provides for spring action when the pedicle 20 screw means is at an an~le relative to the fixation plate, as illustrated in FIG. 7. This spring actiorl enhances the fatigue life of the load transmitting means. The addition of the plate ring means 23 to the spinal fixation system 11 controls the amount of spreading of the f ixation plate 13 as 25 the spinal fixation sys~ em is loaded and unloaded to maintain an optimum load on the ~ertebrae V. The arcuate scallops or depressions 25 and 28 also act as a buttress against increases in angulation of the pedicle screw means 40, thereby tending to keep the pedicle screw means in its 30 initial angular orientation.
Referring to FIG. 8" an alternative embodiment of the load transmitting means, depicted as means 50, includes a pedicle screw means 51 ~nd a spherical nut means 52. The load transmitting means 50 further includes a locknut 55 35 which can be threaded on the pedicle screw means against the WO 93/01772 PCr/US92/05905 2 -14- !~
nut means 52 to maintain the position of the nut means relative to the pedicle screw means 51. The pedicle screw means 51 includes a second threaded portion 60 which is substantially similar to the bone screw ~ortion 44 of the 5 previous embodiment. In a variation from the previous embodiment of the pedicle screw means 40, the screw means 51 includes a longer first threaded portion 58 which extends substantially away from the surface of the fixation plate 13. The end 59 of the first threaded portion 58 can be lO formed to engage a driving or insertion tool. The locknut 55 and spherical nut means 52 are~threaded onto the extended first threaded portion 58 against the fixation plate 13. It is understood that the excess length of the first threaded portion 58 can be severed just above the locknut 55.
The pedicle screw means 51 includes an intermediate portion 62. This intermediate portion includes a driving portion 64 which is connected to the second threaded or bone screw portion 60 by a necked down segment 66. An arcuate surface 68 is formed at the top face of the driving portion 20 64 ad3acent and integral with the first threaded portion 58.
This arcuate surface 68 is substanti ally identical to the arcuate surface 47 of the pedicle screw means 40 of the previous embodiment. It can be noted that while the arcuate surface 68 of this embodiment is ~integral with the first and 25 second threaded portions, an additional spherical IIUt like the nut means 52 can be inverted and threaded onto the first threaded portion to provide the arcuate sllrface. In this modification, the spherical surface 68 would be eliminated in favor of tile inverted spherical nut which would be threaded 30 down onto the driving portion 64 of the integral intermediate portion 62.
In an alternative embodiment of the fixation plate means of the present invention, a fixation plate means or plate 13' is provided which is substantially similar to the fixation 35 plate 13 silown in FIGS. 2 and 3. However, with this WO 93/01712 PCrIUS92/05905 ` 2~13112 alternative embodimellt, the elongated slot 21' includes a single concave surface 25' which extends along substantially the entire perimeter of the slot 21', at the first or bottom side 17' of the plate 13'. The lower concave surface 25' 5 terminates in lower end depressions 26 ' at opposite ends of the elongated slot 21', The opposite or top side of the plates preferably includes a plurality of upper concave depressions (not shown), such as the depressions 28 and 29 of the previous 10 embodiment of plate 13. Thus, concave depressions in the top side of the plate provide means for locating a load transmitting means, SUCII as means 15 or 50, along the longitudinal length of the fixation plate 13'. The lower concave surface 25 at l he bottom side 17~ of the plate 13 ~
15 allows for even greater angularity of the load transmitting means relative to the fixation plate 13 ' than normally permitted by the previo~ls double-scalloped plate 13.
In this embodiment, as in the previous embodiment of the fixation plate, the arcuate surfaces of the load transmitting 20 means remain in contact with the concave surfaces at the top and bottom of the plate 13', even at relative large angles, to efficiently transmit forces from t~le spine to the fixation plate. However, while this embodiment permits greater angulation, the spring or buttressing eEfect is reduced from 25 the scalloped version of the previous embodiment since the pedicle screw means may slide somewhat along the lower concave surface 25 ' under certain loads .
An alternative embodiment or~ the pedicle screw means ~or use witll the present invention is deplcted in FIG. 10. A
30 pedicle screw means 70 is provided which includes a first threaded portion 72 adapted to engage a machine threaded nut, such as nut 32 shown in FIG. 4. The means 70 also includes a second threaded portion 74 conf igurea into bone engaging threads. An intermediate portion 76 separates the first and 35 second threaded portions 72 and 74, respectively. In this 2 ~
respect, the pedicle screw rneans 70 is similar to the pedicle screw means 40 of the previous embodiment.
T~le pedicle screw means 70 differs from the previous screw means 40 in the configuration of the intermediate 5 portion 76. In this alternative embodiment, the intermediate portion 76 includes a lower arcuate surface 77 joined by a constant diameter surface 78 to an upper arcuate surface 79.
In this embodiment, the radii of curvature of the lower and upper arcuate surfaces, 77 and 79 respectively, are 10 different. The upper arcuate surface 79 is formed at a spherical radius that is much greater than the spherical radius of the lower arcuate surface 77. In one specific embodiment, the upper arcuate surface has a spherical radius of 0.787 inches, while the lower arcuate surface spherical 15 radius is 0.394 inches. Preferably, the lower spherical radius is approximately one-half the upper spherical radius.
The pedicle screw means 70 also includes a lower transition portion 82 between the intermediate portion 76 and the second threaded portion 74. This transition portion 82 20 is formed by terminating the bone engaging threads prior to the intermediate portion ( in contrast to the screw means 40 of FIG. 4). This lower transition portion 82 increases the fatigue llfe of the pedicle screw means 70 and reduces the possibility of failure of the screw means at the junction 25 between the bone engaging threads and the intermediate portion. A similar upper intermediate portion 84 is provided between the first threaded portion 72 and the intermediate .-portion 76 for substantially the same reasons.
One advantage of t~le pedicle screw means 70 of this 30 alternative embodiment is illustrated by a comparison between the fixation configurations depicted in FIG. 6 and FIG. 11.
As shown in FIG. 6, the pedicle screw means 40 is first engaged in the vertebra V and then the plate means 13 mounted over the first threaded portion 42. Similarly, the pedicle 35 screw means 70 of FIG . 10 can be substi tuted for the screw WO 93/0l772 PCI/US92/OS9û5 2~1311~
means 40 in the fixation construct 6hown in FIG. 6. In this instance, the upper arcuate surface 79 would engage the lower depression 25 of the plate means 13. The upper arcuate surface 79 has a shallower radius of curvature than the lower 5 depression 25, thereby pr~ ; fli nq a less rigid construct than afforded by the spherical intelrnediate portion 47 of the pedicle screw means 40.
Alternatively, the pedicle screw means 70 can be utilized as a bone screw in which the plate means 13 is first situated 10 over the af fected vertebra and the second bone engaging threaded portion 74 e~tended through the slot 21 in the plate means 13, as shown in FIG. 11. With this construct, the lower arcuate surf ace 77 of the pedicle screw means 70 rests within an upper depression 28 of the plate means 13. The 15 radius of curvature of tlle lower arcuate surface 77 is nearly equal to the radius of curvature of the upper depression 28, thereby providing a more rigid engagement between the screw means 70 and the plate means 13. In this configuration, the first threaded portion 72 is essentially superfluous once the 20 screw means is tightly t~lreaded into the vertebra. The he~
cavity 73 at the end of the first threaded portion 72 provides means for engaging an allen wrench to tighten the screw means 70 into the bone . Af ter the screw means 70 has been implanted, the first threaded portion 72 can be removed 25 or broken off in conventional fashion.
It should be apparent from tlle foregoing description that the pedicle screw means 70 of the alternative embodiment provides an even greater range of utility than the first described embodiment. The curvatures of the upper and lower 30 arcuate surfaces of the intermediate portion 76 can be modified to achieve the degree of fixation and rigidity dictated by the particular in-stallation. The ability of the screw means 70 to be used as a bone bolt, as shown in FIG. 4, or as a bone screw, as shown in FIG. Il, eliminates the need 35 for a number of different load transmitting members.
WO 93/01772 PCr/US92/05905 O
21131~ 2 -18-While the invention has been illustrated and described in detail in tlle drawings and foregoing description, the same is t:o be considered as illustrative and not restrictive in character, it being understood tllat only the preferred 5 embodiment has been shown and described and that all changes and modifications that come within the spirit of the invention are desired to be protected.
For instance, each of the components of the spinal fixation system of the present invention may be machined fron~
o stainless steel stock. It is understood that other suitable materials may be identified by those of ordinary skill in the art .
2~ 13~ 12 BACKGROUl;l ~ OF THE I NVENT I ON
The present invention relates to spinal fixation methods 10 and systems. In particular, the invention concerns a fixation plate and bone screw sys~em for attachment to vertebral bodies to hold the vertebrae in alignment.
Within the last few decades, spinal fixation systems have been developed using generally rigid plates whicll are engaged 15 between vertebrae of the spine, typically on opposite sides of the spinous processes. One such type of spinal plate is illustrated in the patents to Stelfee, U.S. Patent Nos.
4,611,581 and ~1,696,290. In this devic~, a spinal plate is provided which has a series of openings therein for receiving 20 the threaded portions of force transmitting members. The force transmitting members comprise a dual-threaded screw which includes a first threaded portion for engaging the bone of the vertebrae, and a second threaded portion which projects outwardly from the vertebrae and through the 25 openings in the spinal pla~ e. The dual-threaded bone screws in the Steffee apparatus are engaged to the bone plate by way of a nut which is tightened onto the second threaded portion of the force transmitting members and against the plate. The spinal plate described in the Steffee references includes a 30 number of bridge elements between the elongated openings in the plate which tend to increase the rigidity of the plate.
WO 93/01772 PCr/US92/0~905 -2- 21~3~12 ~
Another type of spinal fixation system is shown in t~1e patent to~Luque, U.S. Patent No. 4,790,297, which has been assigned to the assignee of the present invention. In thi~
system, a spinal fixation plate includes a single elongated 5 opening which extends substantially across the length of the plate. A number of depressions are formed in the top surface of the plate at the edge of the çentral elongated opening.
These depressions are used to engage a convex portion of a bone screw which extends through the opening in the bone o plate and into the vertebral bone. The system also includes a plate ring which encircles the plate to prevent the plate from spreading when the bone screws are tightened down onto the bone plate. The plate ring can be situated at any position along the length of the fixation plate.
One difficulty encountered by prior plating fixation systems is the failure of the pedicle screw. For instance, with the Steffee system, the first threaded portion ~or bone screw portion) includes a nut surface which contacts the bottom face of the fixation plate when the separate nut is 20 tightened against the top face of t11e plate. In practice it has been found that the nut surface does not contact flush against the bottom face of the fixation plate, thereby leaving an unsupported sectior1 of the second threaded or nut engagement portion exposed beneath the plate. This results 2s in stress risers in the second threaded portion which are susceptible to fatigue failure under the cyclic loads generated by spinal motion. An increase in the angular deviation or angulation of the screw to the fixation plate in the Steffee system may increase the stresses and the 30 likelihood of fatigue failure. ~ ~
Another related disadvantage of some of the prior s~inal fixation systems using a generally rigid bone plate is that the plates do not per1nit a beneficial amount of angulation between the bone screws and the plate, which may be reguired 35 to account for various angles of fixation to the vertebrae or WO 93/01772 PCr/US92/05905 ' 2113~12 to accommodate normal sagittal curvature of the spine. In these prior devices, this angulation is often provided by bending the bone plate itself to conform to curvature between adjacent vertebrae. ~e~,ding the plate presents difficulty in 5 properly aligning the pedicle screw with the vertebrae.
Optimally, in plate spinal fixation systems, a compromise in stiffness and rigidity of the system is required so that the system is stiff enough to challenge the bone to facilitate bone fusion cf the spine, and not so rigid that 10 normal loads on the spine will lead to fatigue failures of the bone screws. Present fixation systems do not appear capable of achieving this compromise.
There is therefore a need for a spinal fixation system which can more easily ccmpromise the rigidity needs for bone 15 growth and for protection of the fixation system components.
In other words, the need exists for a fixation system that has increased stiffness characteristics without the accompanying tendency for fatigue failures.
There is also a need for a spinal f ixation system that is 20 capable of achieving angulation between the bone-engaging screws without the necessity of bending and forming the bone plate itself. A further need exists for a spinal fixation system in which the load transmitted from the vertebral bone to the force transmitting member can be transmitted to the 25 fixation plate at an angle other than generally perpendicular to the plate surface.
WO 93/01772 PCr/US92/05905 ~113112 4_ ~
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. l is a pictorial plan view of a portion of a patient's spinal column with a pair of the spinal fixation systems according to the present invention secured thereto.
FIG. 2 is a perspective view of the fixation plate means of tlle spinal fixation system of the present invention.
FIG . 3 is a cross-sectional view of the f ixation plate means in FIG. 2 taken along line 3-3 as viewed in the direction of the arrows.
FIG. 4 is an exploded side elevation view of the load transmitting means of the spinal fixation system of the present invention, FIG. 5 is an end view of the pedicle screw means of the load transmitting means shown in FIG. 4 taken along line 5-5 15 as viewed in the direction of the arrows.
FIG. 6 is an enlarged sectional view of a vertebrae with the spinal fixation system attached thereto, taken along 6-6 in FIG. l as viewed in the direction of the arrows.
FIG. 7 is a side schematic representation of the spinal 20 fixation systeln of the present invention showing a pair of load transmitting means at different relative angles to each other .
FIG. 8 is a side elevational representation of the load transmitting means of an alternative embodiment of the spinal 25 f ixation system of the present invention .
FIG. 9 is a bottom elevation view of an alternative embodiment of a fixation plate means for use with the spinal fixation system of the present invention.
FIG. l0 is a side elevation view of the load transmitting 30 means of another embodiment of the spinal fixation system of the present ir1vention.
FIG. ll is an enlarged sectional view of a vertebrae similar to the view of FIG. 6 with the load transmitting means of FIG. l0 engaged between the vertebra and a fixation 35 plate identical to the plate shown in FIG. 6.
_ _ _ _ _ _ _ _ _ _ _ , . .. . . . .. .. . .. . . ..
~5~ ~113112 SUMMARY OF THE INVENTION
T}le present invention provides a spinal fixation syste which addresses the problems encountered by prior such systems. According to one embodiment of the invention, the 5 system comprises an elongated plate having a bottom side for facing the vertebrae an~ an opposite top side extending generally parallel to the bottom side. The plate further includes an elongated slot defi11ed therethrough between the bottom side and the top side which extends substantially 10 along the length of the plate. The slot has a lower edge at t}1e intersection of the slot and the bottom surface and an upper edge at the intersection of the slot and the top surface. A number of first concave depressions are formed at the lower edge of the slot and a number of second concave 15 depressions are formed ~t the upper edge of the slot. In one embodiment, the concave depressions at the upper edge of the slot form a scalloped surface. The lower edge depressions may also form a comparable scalloped surface corresponding to the upper scallops. In another embodiment, the number of 20 first concave depressior,s at the slot lower edge is a single concave surface extendinlg around the en~ire perimeter of the lower edge of the slot.
The system further comprises load transmitting means for engagement between the vertebrae and the elongated plate for 25 transmitting forces therebetween. This load transmitting means includes pedicle screw means having a first threaded portion, a second threaded portion and an intermediate portion between with the first and the second threaded portions. The second th,readed portion includes a number of 30 threads adapted to engage the bone of the vertebrae. The intermediate portion ha~ a rigid upper arcuate surface facing toward the first thread~d portion, w~1ich upper arcuate surface is substantially complementary to the number of first concave depressions in the fixation plate to be received WO 93/01772 PCr/US92/05905 2~13112 ~ i --6--therein. The load transmitting means also includes a nut having a threaded head portion for engaging the first threaded portion of the pedicle screw means and a rigid lower arcuate surface. The lower arcuate surface is substantially 5 complementary to the number of second concave depressions at the upper edge of the slot to he received therein.
In the assembled configuration of the spinal fixation system, the pedicle scre~ means is threaded into the vertebra wit11 the first threaded portion extending outward. The 10 f ixation plate is supported by the intermediate portion of the pedicle screw means, and particularly against the ~1pper arcuate surface. The nut is tightened down along the first threaded portion until it clamps the fixation plate between the intermediate portion of the pedicle screw means and the nut. The lower arcuate surface of the nut is received within an upper concave depression while the upper arcuate surface of the pedicle screw means is received within a lower concave depression .
In an alternative assembled configuration, the pedicle screw means is threaded into the vertebra with the lower arcuate surface of the intermediate portion situated in an upper concave depression of the plate. The pedicle screw means is extended through the plate slot and threaded directly into the vertebra through the plate slot until the irltermediate portion pulls the plate adjacent or into contact with the vertebra. The first threaded portion of the pedicle screw means can be removed once the screw means has been threaded into the bone. It is clear that the sa1ne pedicle screw means can be engaged in the vertebra as a bone screw or a bone bolt, depending upon the degree of fixation and rigidity required at t}1e location of the pedicle screw means. In one specific embodiment of the pedicle screw means, the intermediate portion is configured to readily accept either assembled configuration.
In one aspect of the invention, the first and second WO 93/01772 PCr/US92/05905 ~3~
concave depressions and the upper and lower arcuate surfaces coact to permit angulation of the pedicle screw means relative to the elongated plate. The arcuate surfaces and concave depressions maintain in load transmitting contact 5 over a wide range of angles 50 that forces generated by motion of the spinal c~1~mn are efficiently transmitted to the fixation plate even when the pedicle screw means are at an angle to the pl_'e.
It is one object of the plate spinal fixation system of 10 the present invention to achieve an optimum compromise in stiffness and rigidity of the system so that the system is stiff enough to challenge the bone to facilitate bone fusion of the spine, and not so rigid that normal loads on the spine will lead to fatigue failures of the bone screws. Another 15 object i5 to provide a spinal f i~ation system that is capable of achieving angulation between the bone-engaging screws without the necessity of bending and forming the bone plate i tself .
A further object resides in a spinal fixation system in 20 which the load transmitted from the Yertebral bone to the load transmitting member can be efficiently transmitted to the fixation plate at an angle other than generally perpendicular to the plate surface. A related object is to permit load transmission at angles to the fixation plate 25 without creating stress risers or concentrations in the force transmitting member.
Still another object contemplated by the invention is to provide a load transmission member and spinal plate construct that can accommodate different configurations to achieve 30 different de~rees of fixation and rigidity. Other objects, as well as certain benefits, of the present invention will become apparent from the following written description and accompanying f igures .
WO93/01772 ~ t PCr/US92/05905 21~3112 ff DESCRIPTION OF THE PREFERRE~ EMBODIMENT
For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the embodiment illustrated in the drawings and specific 5 language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated device, and such further applications of the principles of the invention as 10 illustrated therein being contemplated as would normally occur to one skilled in the art to which the invention relates .
In a preferred embodiment of the invention, a spinal fixation system 11 is depicted in FIG. 1 which is used for 15 segmental fixation of the vertebrae V of a spinal column.
The spinal fixation system 11 comprises, in general, a substantially rigid spinal plate means or plate 13 and at least a pair of load transmitting means 15. Typically, a fixation system 11 is utilized on each side of the spinal 20 column or spinous processes, as shown in FIG. 1, and may be used to fix a plurality of levels of the spinal column, as will be apparent to those skilled in the art. The load transmitting means 15 are engaged with the vertebrae and operate to transmit forces from the spinal column to the 25 fixation plate means 13.
Plate ring means or plate ring 23 is provided with the spinal fixation system 11 which at least substantially encircles the fixation plate means 13 (see also FIG. 6). The construction and object of the plate ring 23 of the present 30 invention is substantially as shown and described in the commonly owned patent to Luque, U.S. Patent No. 4,790,297.
(For instance, see column 4, lines 1-12 of the subject patent. ) For purposes of the present invention, the plate ring 23 encircles the fixation plate 13 to prevent the plate WO 93/01772 PCI~US9~/05905 211311~
g 13 from spreading when the load transmitting means 15 are tightened or snugged do~n onto the plate 13. The plate ring 23 can comprise a substantially rectangular body having a substantially rectangular slot therethrough for allowing the 5 plate ring 23 to slide over the plate 13.
Referring to FIGS. 2 and 3, the fi~ation plate means or plate 13 is illustrated as having a first or bottom side 17 and an opposite second or top side 19. The bottom side 17 is directed toward the vertebrae V when the spinal fixation 10 system 11 is in its operative position, while the top side 19 is directed away from the vertebrae. The plate 13 has an elongated slot 21 extending between the bottom and top sides 17 and 19 substantially along the longitudinal length or a2~is of the plate 13. The lc~wer edge of the slot 21 adjacent the 15 bottom side 17 of the plate includes a plurality of lower concave depressions 25. Similarly, ti~e upper edge of the slot 21 adjacent the top side 19 of the plate includes a comparable plurality of upper concave depressions 28. At the bottom side of the plate 17, a pair of opposite lower end 20 depressions 26 are formed at the end of slot 21. A
comparable pair of upper end depressions 29 are situated at the ends of the elongated slot 21 at the top side 19 of the plate 13.
Concave depressions 25 and 28 are preferably positioned 25 completely around all sides of the slot 21 at the bottom and top sides of the plate in a spaced side-by-side relationship. The concave depressions 25 or 28 at either side 17 or 19 of the plate are aligned on opposite sides of the slot 21. Moreover, t~le depressions 25 on tlle bottom side 30 17 are aligned with the depressions 28 on the bottom side 19. The plate 13 thus appears as a "double-scalloped" plate, with a scalloped upper surface and a scalloped lower surface.
The plate 13 may be constructed in various manners. For instance, the slot and depressions may be machined out of a 35 stainless steel bar of various lengths from 1 to 4 inches.
WO 93/01772 PCr/US92/05905 2113~ :~2 ~
The de~ressiorls 25, 26, 28 and 29 are preferably formed by spherical cuts in the bar, having, in one specif ic embodiment, a diameter of 0.315 inches.
The load transmitting means 15, shown in detail in FIG.
5 4, includes a spherical nut 32 and pedicle screw means 40.
The nut 32 includes a head portion 34, which is preferably config~lred as a hex head for engagement by a tightening tool, such as a wrench. The nut 32 further includes a lower arcuate surface 36 which is disposed wit~lin the upper concave 10 depressions 28 or upper end depressions 29 at the top side 19 of the plate 13 when the fixation system is in its operative position. Thus, the diameter of the lower arcuate surface 36 is preferably equal to the diameter of the upper depressions 28 and 29. The spherical nut 32 includes internal female 15 threads for engaging the pedicle screw means 40 of the load transmitting means 15.
The pedicle screw means 40 includes an elongated shaft having a first threaded portion 42 and a second threaded portion 44 . The f i rst threaded portion 4~ includes a number 20 of male threads which are adapted to engage the internal threads 38 of the spherical nut 32. The second threaded portion 44 is configured into a bone helix with a substantially blunt end 45. The threads of the bone helix are adapted to engage the bone tissue of the vertebrae V into 25 which the pedicle screw means 40 is threaded. The configuration of the bone helix of the second threaded portion 44 can be constructed in various manners and in various sizes known to those skilled in the art.
The shaft of the pedicle screw means 40 also includes an 30 integral intermediate portion 46 between the first threaded portion 42 and the second threaded portion 44, so that the pedicle screw means 40 defines a dual-threaded bone screw.
In one embodiment, the intermediate portion includes an upper arcuate surface 47. The upper arcuate surface 47 is adapted 35 to engage the lower concave depressions 25 and 26 in the WO 93/01772 PCr/US92/0590~
~ 3~2 bottom side 17 of the ~late 13. The diameter of the upper arcuate surface 47 is preferably spherical in configuration and has a diameter at least equal to the diameter of tile lower concave depressions 25 and 26. In the illustrated 5 embodiment, the intermediate portion 46 is shown as substantially spherical. However, it is understood that t~le intermediate portion 46 may be truncated leavirlg only the upper arcuate surf ace 47 .
The pedicle screw means 40 is provided with a cavity 49 10 formed in the end of the pedicle screw means adjacent the first threaded portion 42. Preferably, the caYity 49 is hexagonal in configuration for engaging an insertion tool.
The pedicle screw means 40 may also be cannulated to include a bore 48 extending tllrough the entire length of the screw 15 means.
To insert the pedicle screw means 40 into the vertebrae, the preferred spinal fixation method calls for tapping the vertebrae V using a scr~ew tap as is known in the art. Tapped threads can be made in each o~ the levels oF the spinal 20 column to which the spinal fixation system 11 is to be fixed. For instance, as shown in FIG. 1, threads are tapped into three vertebrae V. The pedicle screw means 40 can then be threaded into the tapped bone opening by usirlg a suitable driving too engaged witlhin the hex cavity 49 at the end of 25 the pedicle screw means 40. A guide wire temporarily inserted into the bone can be used to properly align the pedicle screw means as it is threaded into the bone opening, in which instance the guide wire extends through the bore 48.
The pedicle screw m~ans 40 is preferably threaded illtO
30 the bone to a predetermined depth that is ascertained so that the upper arcuate surface 47 can contact the lower concave depressions 25 of the fixation plate means while the fixation plate 13 is situated between processes of the vertebrae V, as shown in FIG. 6. Thus, as shown in FIG. 6, the intermediate 35 portion 46 of the pedicle screw means 40 does not contact the vertebra .
WO 93/01772 2 1 1 3 1 1 2 PCr/US92/0590s Once a pedicle screw means 40 has been threaded into each of the tapped openings in the vertebrae V, t~le fixation plate 13 can be placed against the arcuate surfaces 47 of each of the pedicle screw mearls 40. It is understood that the lower 5 concave depressions 25 and the upper arcuate surfaces 47 of each of the pedicle screw means 40 coact to pernlit angulatio between the pedicle screw means and the fi~ation plate means. In other words, the pedicle screw means is permitted to fit t~le plate 13 at several angles to accommodate abnormal l0 pedicle conditions . Once the f ixation plate has been properly aligned and situated with concave depressions 25 contacting the upper arcuate surf aces 47 of pedicle screw means 40, a spherical nut 32 can be engaged onto the first threaded portion 42 of each of the pedicle screw means.
The spherical nut 32 is then tightened down along the first threaded portion 42 until the lower arcuate surface 36 of the nut 32 engages the upper concave depressions 28 of the ixation plate 13. Again, the lower spherical surface 36 of the nut 32 and the upper concave depressions 28 coact to 20 allow the pedicle screw means 40 to fit the plate 13 at various angles. Moreover, the lower spherical surface 36 and upper concave depressions 28 provide means for aligning the pedicle screw means 40 along the length of the fi~ation plate 13. The coaction of these two surfaces prevents the pedicle 25 screw means from migrating along the length of the plate under loading from the spinal column.
As shown in FIG. 7, a pair of pedicle screw means 40 can be engaged within Yertebrae, not shown in the figure, at differing angles. The leftmost pedicle screw means 40 is 30 shown situated at an angle "A" relative to a perpendicular to the plate 13, while the right-most pedicle screw means g0 is oriented perpendicular to the plate. Unlike prior spinal fixation systems, the present embodiment of the invention provides spherical contacts at the top and bottom sides of 35 the fixation plate between the fixation plate 13 and the load WO 93/01772 PCI`~US92/0590~
~13~1~
transmitting means 15. These spherical contacts permit angulation between the ~-omponents when the spina~ f ixation system is installed in ,~ patient. Moreover, the spherical contacts allow the load from the spinal column passing 5 through the vertebrae V to the load transmitting means 15 to be more efficiently trallsmitted to the fixation plate 13 even when the pedicle screw means is at an angle "A" as depicted in FIG. 7.
The combination of the f ixation plate means 13 and the 10 load transmitting means 15 of the present invention provides a beneficial compromise between the need to control the loads exerted upon the pedicle screw means 40 and the need to challenge the bone tisslle to facilitate bone fusion. As a further advantage, the ~ingle slot 21 of the plate means 13 15 within w}lich the load t]~ansmitting means 15 react allows a spring action in the pl~te as the plate 13 spreads under increasing loads. The coaction between the arcuate surfaces of the fixation plate alld the load transmitting means particularly provides for spring action when the pedicle 20 screw means is at an an~le relative to the fixation plate, as illustrated in FIG. 7. This spring actiorl enhances the fatigue life of the load transmitting means. The addition of the plate ring means 23 to the spinal fixation system 11 controls the amount of spreading of the f ixation plate 13 as 25 the spinal fixation sys~ em is loaded and unloaded to maintain an optimum load on the ~ertebrae V. The arcuate scallops or depressions 25 and 28 also act as a buttress against increases in angulation of the pedicle screw means 40, thereby tending to keep the pedicle screw means in its 30 initial angular orientation.
Referring to FIG. 8" an alternative embodiment of the load transmitting means, depicted as means 50, includes a pedicle screw means 51 ~nd a spherical nut means 52. The load transmitting means 50 further includes a locknut 55 35 which can be threaded on the pedicle screw means against the WO 93/01772 PCr/US92/05905 2 -14- !~
nut means 52 to maintain the position of the nut means relative to the pedicle screw means 51. The pedicle screw means 51 includes a second threaded portion 60 which is substantially similar to the bone screw ~ortion 44 of the 5 previous embodiment. In a variation from the previous embodiment of the pedicle screw means 40, the screw means 51 includes a longer first threaded portion 58 which extends substantially away from the surface of the fixation plate 13. The end 59 of the first threaded portion 58 can be lO formed to engage a driving or insertion tool. The locknut 55 and spherical nut means 52 are~threaded onto the extended first threaded portion 58 against the fixation plate 13. It is understood that the excess length of the first threaded portion 58 can be severed just above the locknut 55.
The pedicle screw means 51 includes an intermediate portion 62. This intermediate portion includes a driving portion 64 which is connected to the second threaded or bone screw portion 60 by a necked down segment 66. An arcuate surface 68 is formed at the top face of the driving portion 20 64 ad3acent and integral with the first threaded portion 58.
This arcuate surface 68 is substanti ally identical to the arcuate surface 47 of the pedicle screw means 40 of the previous embodiment. It can be noted that while the arcuate surface 68 of this embodiment is ~integral with the first and 25 second threaded portions, an additional spherical IIUt like the nut means 52 can be inverted and threaded onto the first threaded portion to provide the arcuate sllrface. In this modification, the spherical surface 68 would be eliminated in favor of tile inverted spherical nut which would be threaded 30 down onto the driving portion 64 of the integral intermediate portion 62.
In an alternative embodiment of the fixation plate means of the present invention, a fixation plate means or plate 13' is provided which is substantially similar to the fixation 35 plate 13 silown in FIGS. 2 and 3. However, with this WO 93/01712 PCrIUS92/05905 ` 2~13112 alternative embodimellt, the elongated slot 21' includes a single concave surface 25' which extends along substantially the entire perimeter of the slot 21', at the first or bottom side 17' of the plate 13'. The lower concave surface 25' 5 terminates in lower end depressions 26 ' at opposite ends of the elongated slot 21', The opposite or top side of the plates preferably includes a plurality of upper concave depressions (not shown), such as the depressions 28 and 29 of the previous 10 embodiment of plate 13. Thus, concave depressions in the top side of the plate provide means for locating a load transmitting means, SUCII as means 15 or 50, along the longitudinal length of the fixation plate 13'. The lower concave surface 25 at l he bottom side 17~ of the plate 13 ~
15 allows for even greater angularity of the load transmitting means relative to the fixation plate 13 ' than normally permitted by the previo~ls double-scalloped plate 13.
In this embodiment, as in the previous embodiment of the fixation plate, the arcuate surfaces of the load transmitting 20 means remain in contact with the concave surfaces at the top and bottom of the plate 13', even at relative large angles, to efficiently transmit forces from t~le spine to the fixation plate. However, while this embodiment permits greater angulation, the spring or buttressing eEfect is reduced from 25 the scalloped version of the previous embodiment since the pedicle screw means may slide somewhat along the lower concave surface 25 ' under certain loads .
An alternative embodiment or~ the pedicle screw means ~or use witll the present invention is deplcted in FIG. 10. A
30 pedicle screw means 70 is provided which includes a first threaded portion 72 adapted to engage a machine threaded nut, such as nut 32 shown in FIG. 4. The means 70 also includes a second threaded portion 74 conf igurea into bone engaging threads. An intermediate portion 76 separates the first and 35 second threaded portions 72 and 74, respectively. In this 2 ~
respect, the pedicle screw rneans 70 is similar to the pedicle screw means 40 of the previous embodiment.
T~le pedicle screw means 70 differs from the previous screw means 40 in the configuration of the intermediate 5 portion 76. In this alternative embodiment, the intermediate portion 76 includes a lower arcuate surface 77 joined by a constant diameter surface 78 to an upper arcuate surface 79.
In this embodiment, the radii of curvature of the lower and upper arcuate surfaces, 77 and 79 respectively, are 10 different. The upper arcuate surface 79 is formed at a spherical radius that is much greater than the spherical radius of the lower arcuate surface 77. In one specific embodiment, the upper arcuate surface has a spherical radius of 0.787 inches, while the lower arcuate surface spherical 15 radius is 0.394 inches. Preferably, the lower spherical radius is approximately one-half the upper spherical radius.
The pedicle screw means 70 also includes a lower transition portion 82 between the intermediate portion 76 and the second threaded portion 74. This transition portion 82 20 is formed by terminating the bone engaging threads prior to the intermediate portion ( in contrast to the screw means 40 of FIG. 4). This lower transition portion 82 increases the fatigue llfe of the pedicle screw means 70 and reduces the possibility of failure of the screw means at the junction 25 between the bone engaging threads and the intermediate portion. A similar upper intermediate portion 84 is provided between the first threaded portion 72 and the intermediate .-portion 76 for substantially the same reasons.
One advantage of t~le pedicle screw means 70 of this 30 alternative embodiment is illustrated by a comparison between the fixation configurations depicted in FIG. 6 and FIG. 11.
As shown in FIG. 6, the pedicle screw means 40 is first engaged in the vertebra V and then the plate means 13 mounted over the first threaded portion 42. Similarly, the pedicle 35 screw means 70 of FIG . 10 can be substi tuted for the screw WO 93/0l772 PCI/US92/OS9û5 2~1311~
means 40 in the fixation construct 6hown in FIG. 6. In this instance, the upper arcuate surface 79 would engage the lower depression 25 of the plate means 13. The upper arcuate surface 79 has a shallower radius of curvature than the lower 5 depression 25, thereby pr~ ; fli nq a less rigid construct than afforded by the spherical intelrnediate portion 47 of the pedicle screw means 40.
Alternatively, the pedicle screw means 70 can be utilized as a bone screw in which the plate means 13 is first situated 10 over the af fected vertebra and the second bone engaging threaded portion 74 e~tended through the slot 21 in the plate means 13, as shown in FIG. 11. With this construct, the lower arcuate surf ace 77 of the pedicle screw means 70 rests within an upper depression 28 of the plate means 13. The 15 radius of curvature of tlle lower arcuate surface 77 is nearly equal to the radius of curvature of the upper depression 28, thereby providing a more rigid engagement between the screw means 70 and the plate means 13. In this configuration, the first threaded portion 72 is essentially superfluous once the 20 screw means is tightly t~lreaded into the vertebra. The he~
cavity 73 at the end of the first threaded portion 72 provides means for engaging an allen wrench to tighten the screw means 70 into the bone . Af ter the screw means 70 has been implanted, the first threaded portion 72 can be removed 25 or broken off in conventional fashion.
It should be apparent from tlle foregoing description that the pedicle screw means 70 of the alternative embodiment provides an even greater range of utility than the first described embodiment. The curvatures of the upper and lower 30 arcuate surfaces of the intermediate portion 76 can be modified to achieve the degree of fixation and rigidity dictated by the particular in-stallation. The ability of the screw means 70 to be used as a bone bolt, as shown in FIG. 4, or as a bone screw, as shown in FIG. Il, eliminates the need 35 for a number of different load transmitting members.
WO 93/01772 PCr/US92/05905 O
21131~ 2 -18-While the invention has been illustrated and described in detail in tlle drawings and foregoing description, the same is t:o be considered as illustrative and not restrictive in character, it being understood tllat only the preferred 5 embodiment has been shown and described and that all changes and modifications that come within the spirit of the invention are desired to be protected.
For instance, each of the components of the spinal fixation system of the present invention may be machined fron~
o stainless steel stock. It is understood that other suitable materials may be identified by those of ordinary skill in the art .
Claims (14)
1. A spinal fixation system for maintaining vertebrae in a desired relationship comprising:
an elongated plate having;
a bottom side for facing the vertebrae;
an opposite top side extending generally parallel to said bottom side;
an elongated slot defined therethrough between said bottom side and said top side and extending substantially along the length of said plate, said slot having a lower edge at the intersection of said slot and said bottom surface and an upper edge at the intersection of said slot and said top surface, and a number of first concave depressions formed at said lower edge of said slot and a number of second concave depressions formed at said upper edge of said slot; and load transmitting means for engagement between the vertebrae and said elongated plate for transmitting forces therebetween, said load transmitting means including;
pedicle screw means having a first threaded portion, a second threaded portion and an intermediate portion between and integral with said first and said second threaded portions, said second threaded portion including a number of threads adapted to engage the bone of the vertebrae, said intermediate portion having a rigid upper arcuate surface facing toward said first threaded portion, said upper arcuate surface being substantially complementary to said number of first concave depressions to be received therein; and a nut having a threaded head portion for engaging said first threaded portion and a rigid lower arcuate surface which is substantially complementary to said number of second concave depressions to be received therein when said nut is tightened down along said first threaded portion;
wherein said first and second concave depressions and said upper and lower arcuate surfaces are configured to permit angulation of said pedicle screw means relative to said elongated plate when said second threaded portion is engaging the bone of the vertebrae while said upper arcuate surface is in contact with said number of first concave depressions and said lower arcuate surface is in contact with said number of second concave depressions.
an elongated plate having;
a bottom side for facing the vertebrae;
an opposite top side extending generally parallel to said bottom side;
an elongated slot defined therethrough between said bottom side and said top side and extending substantially along the length of said plate, said slot having a lower edge at the intersection of said slot and said bottom surface and an upper edge at the intersection of said slot and said top surface, and a number of first concave depressions formed at said lower edge of said slot and a number of second concave depressions formed at said upper edge of said slot; and load transmitting means for engagement between the vertebrae and said elongated plate for transmitting forces therebetween, said load transmitting means including;
pedicle screw means having a first threaded portion, a second threaded portion and an intermediate portion between and integral with said first and said second threaded portions, said second threaded portion including a number of threads adapted to engage the bone of the vertebrae, said intermediate portion having a rigid upper arcuate surface facing toward said first threaded portion, said upper arcuate surface being substantially complementary to said number of first concave depressions to be received therein; and a nut having a threaded head portion for engaging said first threaded portion and a rigid lower arcuate surface which is substantially complementary to said number of second concave depressions to be received therein when said nut is tightened down along said first threaded portion;
wherein said first and second concave depressions and said upper and lower arcuate surfaces are configured to permit angulation of said pedicle screw means relative to said elongated plate when said second threaded portion is engaging the bone of the vertebrae while said upper arcuate surface is in contact with said number of first concave depressions and said lower arcuate surface is in contact with said number of second concave depressions.
2. The spinal fixation system of the claim 1, wherein said elongated slot includes:
a plurality of opposite pairs of first concave depressions at said lower edge of said slot; and a plurality of opposite pairs of second concave depressions at said upper edge of said slot.
a plurality of opposite pairs of first concave depressions at said lower edge of said slot; and a plurality of opposite pairs of second concave depressions at said upper edge of said slot.
3. The spinal fixation system of the claim 1, wherein said elongated slot includes:
a lower concave surface formed around substantially the entire perimeter of said lower edge of said slot; and a plurality of opposite pairs of second concave depressions at said upper edge of said slot.
a lower concave surface formed around substantially the entire perimeter of said lower edge of said slot; and a plurality of opposite pairs of second concave depressions at said upper edge of said slot.
4. The spinal fixation system of the claim 1, wherein at least said number of first concave depressions of said elongated slot and said upper arcuate surface of said intermediate portion of said pedicle screw means are spherical and define spherical surfaces having substantially the same diameter.
5. The spinal fixation system of the claim 1, wherein at least said number of second concave depressions of said elongated slot and said lower arcuate surface of said nut of said load transmitting means are spherical and define spherical surfaces having substantially the same diameter.
6. The spinal fixation system of claim 1, wherein said pedicle screw means is cannulated.
7. A load transmitting member for use with a spinal fisation system for engagement between the vertebrae and an elongated spinal plate for transmitting forces therebetween, the spinal plate having a top and a bottom side and an elongated slot defined therethrough between the bottom and top sides and extending substantially along the length of the plate, the slot having a lower edge at the intersection of the slot and the bottom surface and an upper edge at the intersection of the slot and the top surface, and a number of first concave depressions formed at the lower edge of the slot and a number of second concave depressions formed at the upper edge of the slot, said load transmitting member comprising:
a first threaded portion having machine threads for engaging a nut;
a second threaded portion having bone engaging threads;
and an intermediate portion between and integral with said first and second threaded portions, said intermediate portion having a rigid upper arcuate surface adjacent said first threaded portion and an oppositely facing rigid lower arcuate surface adjacent said second threaded portion, wherein said upper arcuate surface is defined at a first radius of curvature and said lower arcuate surface is defined at a second radius of curvature that is substantially different from said first radius of curvature.
a first threaded portion having machine threads for engaging a nut;
a second threaded portion having bone engaging threads;
and an intermediate portion between and integral with said first and second threaded portions, said intermediate portion having a rigid upper arcuate surface adjacent said first threaded portion and an oppositely facing rigid lower arcuate surface adjacent said second threaded portion, wherein said upper arcuate surface is defined at a first radius of curvature and said lower arcuate surface is defined at a second radius of curvature that is substantially different from said first radius of curvature.
8. The load transmitting member of claim 7, wherein each of said first radius of curvature and said second radius of curvature is a spherical radius.
9. The load transmitting member of claim 7, wherein said first radius of curvature is substantially greater than said second radius of curvature.
10. The load transmitting member of claim 9, wherein said first radius of curvature is approximately twice said second radius of curvature.
11. A spinal fixation system for maintaining vertebrae in a desired relationship comprising:
an elongated plate having;
a bottom side for facing the vertebrae;
an opposite top side extending generally parallel to said bottom side;
an elongated slot defined therethrough between said bottom side and said top side and extending substantially along the length of said plate, said slot having a lower edge at the intersection of said slot and said bottom surface and an upper edge at the intersection of said slot and said top surface, and a number of first concave depressions formed at said lower edge of said slot and a number of second concave depressions formed at said upper edge of said slot; and load transmitting means for engagement between the vertebrae and said elongated plate for transmitting forces therebetween, said load transmitting means including;
pedicle screw means having a first threaded portion, a second threaded portion and an intermediate portion between and integral with said first and said second threaded portions, said second threaded portion including a number of threads adapted to engage the bone of the vertebrae, said intermediate portion having a rigid upper arcuate surface facing toward said first threaded portion, and a rigid lower arcuate surface; and a nut having a threaded head portion for engaging said first threaded portion and a rigid lower arcuate surface, wherein said rigid lower arcuate surface of said nut, said rigid lower arcuate surface of said intermediate portion of said pedicle screw means and said number of second concave depressions of said plate are each defined by a substantially equal spherical radius, and wherein said rigid upper arcuate surface of said intermediate portion of said pedicle screw means and said number of first concave depressions of said plate are defined by substantially different spherical radii relative to each other.
an elongated plate having;
a bottom side for facing the vertebrae;
an opposite top side extending generally parallel to said bottom side;
an elongated slot defined therethrough between said bottom side and said top side and extending substantially along the length of said plate, said slot having a lower edge at the intersection of said slot and said bottom surface and an upper edge at the intersection of said slot and said top surface, and a number of first concave depressions formed at said lower edge of said slot and a number of second concave depressions formed at said upper edge of said slot; and load transmitting means for engagement between the vertebrae and said elongated plate for transmitting forces therebetween, said load transmitting means including;
pedicle screw means having a first threaded portion, a second threaded portion and an intermediate portion between and integral with said first and said second threaded portions, said second threaded portion including a number of threads adapted to engage the bone of the vertebrae, said intermediate portion having a rigid upper arcuate surface facing toward said first threaded portion, and a rigid lower arcuate surface; and a nut having a threaded head portion for engaging said first threaded portion and a rigid lower arcuate surface, wherein said rigid lower arcuate surface of said nut, said rigid lower arcuate surface of said intermediate portion of said pedicle screw means and said number of second concave depressions of said plate are each defined by a substantially equal spherical radius, and wherein said rigid upper arcuate surface of said intermediate portion of said pedicle screw means and said number of first concave depressions of said plate are defined by substantially different spherical radii relative to each other.
12. The spinal fixation system of claim 11, wherein said number of first concave depressions are defined at a first spherical radius and said rigid upper arcuate surface of said intermediate portion is defined at a second spherical radius that is substantially greater than said first spherical radius.
13. The spinal fixation system of claim 12, wherein said second spherical radius is approximately twice said first spherical radius.
14. The spinal fixation system of claim 12, wherein said lower arcuate surface of said nut, said lower arcuate surface of said intermediate portion of said pedicle screw means and said number of first concave depressions are each defined by said first spherical radius.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US08/177,731 US5346445A (en) | 1992-07-15 | 1994-01-05 | Arm lever for an exercise bicycle |
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US73011591A | 1991-07-15 | 1991-07-15 | |
| US07/730,115 | 1991-07-15 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2113112A1 CA2113112A1 (en) | 1993-02-04 |
| CA2113112C true CA2113112C (en) | 1996-10-22 |
Family
ID=24933976
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002113112A Expired - Fee Related CA2113112C (en) | 1991-07-15 | 1992-07-15 | Spinal fixation system |
Country Status (16)
| Country | Link |
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| US (3) | US5545163A (en) |
| EP (1) | EP0594748A4 (en) |
| JP (1) | JP2506560B2 (en) |
| KR (2) | KR970707716A (en) |
| AR (1) | AR244985A1 (en) |
| AU (1) | AU659667B2 (en) |
| BR (1) | BR9206273A (en) |
| CA (1) | CA2113112C (en) |
| FI (1) | FI940183A0 (en) |
| IE (1) | IE922307A1 (en) |
| MX (1) | MX9204122A (en) |
| NO (1) | NO940141L (en) |
| NZ (2) | NZ243574A (en) |
| PT (1) | PT100685A (en) |
| WO (1) | WO1993001772A1 (en) |
| ZA (1) | ZA925277B (en) |
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- 1992-07-15 KR KR1019940700111A patent/KR0128974B1/en not_active IP Right Cessation
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| MX9204122A (en) | 1993-04-01 |
| KR970707716A (en) | 1997-12-01 |
| JPH06507330A (en) | 1994-08-25 |
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| JP2506560B2 (en) | 1996-06-12 |
| ZA925277B (en) | 1993-04-28 |
| AR244985A1 (en) | 1993-12-30 |
| US5545163A (en) | 1996-08-13 |
| NZ272407A (en) | 1997-03-24 |
| FI940183A (en) | 1994-01-14 |
| US5395371A (en) | 1995-03-07 |
| KR0128974B1 (en) | 1998-04-04 |
| EP0594748A4 (en) | 1994-07-20 |
| NO940141L (en) | 1994-03-11 |
| NZ243574A (en) | 1997-03-24 |
| BR9206273A (en) | 1995-10-10 |
| AU659667B2 (en) | 1995-05-25 |
| PT100685A (en) | 1994-05-31 |
| EP0594748A1 (en) | 1994-05-04 |
| FI940183A0 (en) | 1994-01-14 |
| US5540690A (en) | 1996-07-30 |
| CA2113112A1 (en) | 1993-02-04 |
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