CA1318203C - Spinal fixation device - Google Patents
Spinal fixation deviceInfo
- Publication number
- CA1318203C CA1318203C CA 557556 CA557556A CA1318203C CA 1318203 C CA1318203 C CA 1318203C CA 557556 CA557556 CA 557556 CA 557556 A CA557556 A CA 557556A CA 1318203 C CA1318203 C CA 1318203C
- Authority
- CA
- Canada
- Prior art keywords
- pedicle
- clamp
- articulating
- bone
- bone screws
- 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
Abstract
P.C. 7172 ABSTRACT
SPINAL FIXATION DEVICE
A device for spinal fixation comprises first and second pedicle screw members, a stabilizing member, and an articulating clamp which has securing means for releasably attaching the screw members to the stabilizing member. The device includes locking means such as a clamp bolt to lock the screw members to the articulating clamp.
SPINAL FIXATION DEVICE
A device for spinal fixation comprises first and second pedicle screw members, a stabilizing member, and an articulating clamp which has securing means for releasably attaching the screw members to the stabilizing member. The device includes locking means such as a clamp bolt to lock the screw members to the articulating clamp.
Description
,,,A ~ ~
P.C. 7172 SPINAL FIXATION DEVICE
The present invention relates to a spinal fixation device and a method for fixation of that device between two or more vertebrae. More particularly, it relates 5 to a fixation device that results in inherent structural strength due to a unique method for placement o and linkage between the pedicle screws.
One of the significant problems associated with the design of a spinal fixation device is the need for 10 to localize the involvement of the spinal column. Such 5 a fixation device design should involve fixation r directly at the site of instability rather than two or three vertebrae away from it. The fixation device should rely on bony tissue rather than intact soft 15 tissue to achieve stabilization and maximum patient comfort, and to encourage rehabilitation. A splnal fixation device should be fully internalized, with no pins transfixing the skin or muscle. Further, it is important that the device be easy to implant in an 20 accurate and consistent manner.
U.S. Patent No. 4,604,995 discloses a surgical implant having a unitary rod with a generally rectangular configuration formed by a pair of spaced apart branches which are mirror image duplications of 25 one another and equally spaced along their entire length.
~3182~3 U.S. Patent No. 4,078,559 discloses a straightening and supporting device for the spinal column. The device comprises a rod shaped supporting member at least the length of the spinal column area to be treated and exerting a straightening and supporting effect on the vertebrae of the spinal column.
U.S. Patent No. 4,003,376 discloses an apparatus for straightening the spinal column. The apparatus includes an elongated member securable forwardly of and against the spinal column. A pair of fastening devices extend around the spinal column from the elongated member to a pair of bands located rearwardly of and adjacent the spinal column.
The prosthesis of the present invention overcomes technical, surgical and practical shortcomings of the prior art.
Important features of the present invention are the ability to provide three-dimensional stability adaptability which allows for safer and more secure implantation of the device.
The device of the present invention combines all of these features in one fixation device. These and other features discussed hereinafter result in a device which is dynamically stable and promotes a smooth and natural movement, while accurately and consistently Eixing the spine.
The present invention seeks to provide a device for internalized spinal fixation having three-dimensional adjustability and requiring no violation of the spinal canal, said device comprising: (a) a first and a second bone screw adapted to be screwed at least into a first and a second pedicle, respectively, of two vertebrae along one side of a spinal column f~ 2 1~82~
and for anchoring the device posteriorly with respect to the patient's body in the pedicle area of the spine, said first bone screw to be screwed at least into a pedicle of a first vertebra and said second bone screw to be screwed at least into a pedicle of a second vertebra; (b) a rigid stabilizing rod; (c) a pair of articulating clamps slidably and rotatably positionable at opposite ends of said stabilizing rod, each of said clamps having a securing means for fixedly but releasably attaching one of said bone screws to the stahilizing rod, but without re~uiring said bone screws to be parallel to each other, wherein said securing means comprises radially arranged teeth located on the proximal surface of a bone screw and corresponding intermeshable radially arranged teeth located on a surface of an articulating clamp, and (d) locking means to lock each bone screw to the articulating clamp to which it is to be attached.
2a ~ 3 ~
The novel features and advantages of the present invention will become apparent from a reading of the following detailed description in conjunction with the accompanying drawings wherein:
Fig. 1 is an exploded perspective view of a spinal fixation prosthesis of the invention;
Fig. 2 is a cross-sectional view of the spinal fixation prosthesis of Fig~ 1 taken along lines 2-2 of Fig. l;
Fig. 3 is a front view of the spinal fixation prosthesis in position in the spinal column; and FigO 4 is a cross-sectional view taken along lines 4-4 of Fig. 3.
In Figs. 1-4 is illustrated a spinal fixation 15 device for immobilizing two or more vertebrae in the spinal column of a patient. The spinal fixation device generally indicated at 10 includes first and second pedicle screw members 12, 13, respectively, two articulating clamps 14, a stabilizing member 16, and 20 two clamp bolts 18.
The proximal ends 15 of the pedicle screw members 12, 13 are scored with radially arranged teeth 20. m Preferably, the screws contain from about 10 to 100 teeth, most preferably 60 to 90 teeth. Each of the 25 articulating clamp 14 includes corresponding teeth 22 for securing the screw members 12, 13 to the articulating clamp 14.
_4_ 13~8~
Adjustment of the position of the screw members 12 and 13 relative to stabilizing member 16 is I accomplished by (1) rotational motion of teeth 20 on screw members 12 and 13 about teeth 22 on articulating claimps 14, (2) rotational motion of articulating clamps 14 about stabilizing member 16 and (3) sliding motion of articulating clamps 14 along stabilizing I member 16.
I The screw members 12, 13 are preferably from about j 10 30mm to 60mm long, with the diameter of the pedicle ¦ screw member being preferably from about 2mms to 8mms, and most preferably include a SpiralockTM thread which is primarily used in aircraft and other high vibration applications.
! 15 Arter adjustment, the position between screws 12 and 13 is locked by tightening clamp bolt 18, thus ' preventing the aforementioned rotational and sliding motions. The threads 21 of the screw members 12, 13 ' can be tightened and loosened repeatedly without degradation and have an even load distribution along the engaged threads.
The stabilizing member 16 is preferably a rod-shaped member with a diameter of from about 2mm. to lOmm. The rod should have a length appropriate for the clinical application.
The threaded clamp bolt 18 preferably has a hexagonal head with a major diameter of from about ` 2.0mm. to 8mm., and an overall length of from about lOmm. to 20mms.
r -5- 1318~
Preferably, the stabilizing member, articulating clamps, and first and second pedicle screw members are made from titanium, cobalt chromium surgical implant alloy or, most preferably, 316B strain hardened stainless steel. Additionally, the articulating clamps, stabilizing member and clamp bolts may be made from biocompatible polymeric material.
The components of the spinal fixation device are preferably manufactured by standard machining techniques, for example drilling, burning, grinding, milling and electric polishing.
The use of spinal fixation device 1 will be described with reference to the fixation of the spine at level T12 and into ~2.
The patient is anesthetized while lying on his/her back, then turned onto his/her stomach, using an ~;
operating table which is radiolucent. The incision is (midline) longitudinal over a vertebrae to be instrumented (for example for an Ll burst fracturel.
20 Standard techniques are used for clearing soft tissue off the posterior aspects of the bone out as far as the tips of the transverse processes in a lateral direction. An x-ray image intensifier is used to ensure that the proper levels are dissected, and to 25 guide implantation throughout the procedure. The entry site for the first drill hole is tenatively identified, the drill guide is placed over this site and oriented ! so that by using the image intensifier, the drill guide is centered over the pedicle. The proper sized 30 diameter drill is then used to begin the drill hole, the image intensifier is rotated to show a lateral - ;--6- ~318~
view, and the drill bit is advanced until the selected depth is obtained, (but not so deep as to penetrate through the anterior cortex). The drill bit is then withdrawn, and a vertebral screw of appropriate length and diameter (chosen ahead of time, usually based on the ~T scan x-rays pre-operatively), is then threaded into place. A similar procedure is performed at each of the other three pedicles (four screws are used in most common applications). The articulating mechanism is then loosely attached to each screw head. ~ext, the longitudinal rod is selected for proper length, so that it just barely protrudes above the upper articulating clamp and below the lower articulating clamp. If movement of the vertebra needs to be produced, it is now done at this time, using a special instrument that grips onto the head of the vertebral screws. ~hile this position is held, the clamp bolts are then tightened using the clamp bolt wrench. At this point, if desired (as is generally the case), a bone graft is then put in place and the incision i9 closed.
P.C. 7172 SPINAL FIXATION DEVICE
The present invention relates to a spinal fixation device and a method for fixation of that device between two or more vertebrae. More particularly, it relates 5 to a fixation device that results in inherent structural strength due to a unique method for placement o and linkage between the pedicle screws.
One of the significant problems associated with the design of a spinal fixation device is the need for 10 to localize the involvement of the spinal column. Such 5 a fixation device design should involve fixation r directly at the site of instability rather than two or three vertebrae away from it. The fixation device should rely on bony tissue rather than intact soft 15 tissue to achieve stabilization and maximum patient comfort, and to encourage rehabilitation. A splnal fixation device should be fully internalized, with no pins transfixing the skin or muscle. Further, it is important that the device be easy to implant in an 20 accurate and consistent manner.
U.S. Patent No. 4,604,995 discloses a surgical implant having a unitary rod with a generally rectangular configuration formed by a pair of spaced apart branches which are mirror image duplications of 25 one another and equally spaced along their entire length.
~3182~3 U.S. Patent No. 4,078,559 discloses a straightening and supporting device for the spinal column. The device comprises a rod shaped supporting member at least the length of the spinal column area to be treated and exerting a straightening and supporting effect on the vertebrae of the spinal column.
U.S. Patent No. 4,003,376 discloses an apparatus for straightening the spinal column. The apparatus includes an elongated member securable forwardly of and against the spinal column. A pair of fastening devices extend around the spinal column from the elongated member to a pair of bands located rearwardly of and adjacent the spinal column.
The prosthesis of the present invention overcomes technical, surgical and practical shortcomings of the prior art.
Important features of the present invention are the ability to provide three-dimensional stability adaptability which allows for safer and more secure implantation of the device.
The device of the present invention combines all of these features in one fixation device. These and other features discussed hereinafter result in a device which is dynamically stable and promotes a smooth and natural movement, while accurately and consistently Eixing the spine.
The present invention seeks to provide a device for internalized spinal fixation having three-dimensional adjustability and requiring no violation of the spinal canal, said device comprising: (a) a first and a second bone screw adapted to be screwed at least into a first and a second pedicle, respectively, of two vertebrae along one side of a spinal column f~ 2 1~82~
and for anchoring the device posteriorly with respect to the patient's body in the pedicle area of the spine, said first bone screw to be screwed at least into a pedicle of a first vertebra and said second bone screw to be screwed at least into a pedicle of a second vertebra; (b) a rigid stabilizing rod; (c) a pair of articulating clamps slidably and rotatably positionable at opposite ends of said stabilizing rod, each of said clamps having a securing means for fixedly but releasably attaching one of said bone screws to the stahilizing rod, but without re~uiring said bone screws to be parallel to each other, wherein said securing means comprises radially arranged teeth located on the proximal surface of a bone screw and corresponding intermeshable radially arranged teeth located on a surface of an articulating clamp, and (d) locking means to lock each bone screw to the articulating clamp to which it is to be attached.
2a ~ 3 ~
The novel features and advantages of the present invention will become apparent from a reading of the following detailed description in conjunction with the accompanying drawings wherein:
Fig. 1 is an exploded perspective view of a spinal fixation prosthesis of the invention;
Fig. 2 is a cross-sectional view of the spinal fixation prosthesis of Fig~ 1 taken along lines 2-2 of Fig. l;
Fig. 3 is a front view of the spinal fixation prosthesis in position in the spinal column; and FigO 4 is a cross-sectional view taken along lines 4-4 of Fig. 3.
In Figs. 1-4 is illustrated a spinal fixation 15 device for immobilizing two or more vertebrae in the spinal column of a patient. The spinal fixation device generally indicated at 10 includes first and second pedicle screw members 12, 13, respectively, two articulating clamps 14, a stabilizing member 16, and 20 two clamp bolts 18.
The proximal ends 15 of the pedicle screw members 12, 13 are scored with radially arranged teeth 20. m Preferably, the screws contain from about 10 to 100 teeth, most preferably 60 to 90 teeth. Each of the 25 articulating clamp 14 includes corresponding teeth 22 for securing the screw members 12, 13 to the articulating clamp 14.
_4_ 13~8~
Adjustment of the position of the screw members 12 and 13 relative to stabilizing member 16 is I accomplished by (1) rotational motion of teeth 20 on screw members 12 and 13 about teeth 22 on articulating claimps 14, (2) rotational motion of articulating clamps 14 about stabilizing member 16 and (3) sliding motion of articulating clamps 14 along stabilizing I member 16.
I The screw members 12, 13 are preferably from about j 10 30mm to 60mm long, with the diameter of the pedicle ¦ screw member being preferably from about 2mms to 8mms, and most preferably include a SpiralockTM thread which is primarily used in aircraft and other high vibration applications.
! 15 Arter adjustment, the position between screws 12 and 13 is locked by tightening clamp bolt 18, thus ' preventing the aforementioned rotational and sliding motions. The threads 21 of the screw members 12, 13 ' can be tightened and loosened repeatedly without degradation and have an even load distribution along the engaged threads.
The stabilizing member 16 is preferably a rod-shaped member with a diameter of from about 2mm. to lOmm. The rod should have a length appropriate for the clinical application.
The threaded clamp bolt 18 preferably has a hexagonal head with a major diameter of from about ` 2.0mm. to 8mm., and an overall length of from about lOmm. to 20mms.
r -5- 1318~
Preferably, the stabilizing member, articulating clamps, and first and second pedicle screw members are made from titanium, cobalt chromium surgical implant alloy or, most preferably, 316B strain hardened stainless steel. Additionally, the articulating clamps, stabilizing member and clamp bolts may be made from biocompatible polymeric material.
The components of the spinal fixation device are preferably manufactured by standard machining techniques, for example drilling, burning, grinding, milling and electric polishing.
The use of spinal fixation device 1 will be described with reference to the fixation of the spine at level T12 and into ~2.
The patient is anesthetized while lying on his/her back, then turned onto his/her stomach, using an ~;
operating table which is radiolucent. The incision is (midline) longitudinal over a vertebrae to be instrumented (for example for an Ll burst fracturel.
20 Standard techniques are used for clearing soft tissue off the posterior aspects of the bone out as far as the tips of the transverse processes in a lateral direction. An x-ray image intensifier is used to ensure that the proper levels are dissected, and to 25 guide implantation throughout the procedure. The entry site for the first drill hole is tenatively identified, the drill guide is placed over this site and oriented ! so that by using the image intensifier, the drill guide is centered over the pedicle. The proper sized 30 diameter drill is then used to begin the drill hole, the image intensifier is rotated to show a lateral - ;--6- ~318~
view, and the drill bit is advanced until the selected depth is obtained, (but not so deep as to penetrate through the anterior cortex). The drill bit is then withdrawn, and a vertebral screw of appropriate length and diameter (chosen ahead of time, usually based on the ~T scan x-rays pre-operatively), is then threaded into place. A similar procedure is performed at each of the other three pedicles (four screws are used in most common applications). The articulating mechanism is then loosely attached to each screw head. ~ext, the longitudinal rod is selected for proper length, so that it just barely protrudes above the upper articulating clamp and below the lower articulating clamp. If movement of the vertebra needs to be produced, it is now done at this time, using a special instrument that grips onto the head of the vertebral screws. ~hile this position is held, the clamp bolts are then tightened using the clamp bolt wrench. At this point, if desired (as is generally the case), a bone graft is then put in place and the incision i9 closed.
Claims (8)
1. A device for internalized spinal fixation having three-dimensional adjustability and requiring no violation of the spinal canal, said device comprising:
(a) a first and a second bone screw adapted to be screwed at least into a first and a second pedicle, respectively, of two vertebrae along one side of a spinal column and for anchoring the device posteriorly with respect to the patient's body in the pedicle area of the spine, said first bone screw to be screwed at least into a pedicle of a first vertebra and said second bone screw to be screwed at least into a pedicle of a second vertebra;
(b) a rigid stabilizing rod;
(c) a pair of articulating clamps slldably and rotatably positionable at opposite ends of said stabilizing rod, each of said clamps having a securing means for fixedly but releasably attaching one of said bone screws to the stabilizing rod, but without requiring said bone screws to be parallel to each other, wherein said securing means comprises radially arranged teeth located on the proximal surface of a bone screw and corresponding intermeshable radially arranged teeth located on a surface of an articulating clamp, and (d) locking means to lock each bone screw to the articulating clamp to which it is to be attached.
(a) a first and a second bone screw adapted to be screwed at least into a first and a second pedicle, respectively, of two vertebrae along one side of a spinal column and for anchoring the device posteriorly with respect to the patient's body in the pedicle area of the spine, said first bone screw to be screwed at least into a pedicle of a first vertebra and said second bone screw to be screwed at least into a pedicle of a second vertebra;
(b) a rigid stabilizing rod;
(c) a pair of articulating clamps slldably and rotatably positionable at opposite ends of said stabilizing rod, each of said clamps having a securing means for fixedly but releasably attaching one of said bone screws to the stabilizing rod, but without requiring said bone screws to be parallel to each other, wherein said securing means comprises radially arranged teeth located on the proximal surface of a bone screw and corresponding intermeshable radially arranged teeth located on a surface of an articulating clamp, and (d) locking means to lock each bone screw to the articulating clamp to which it is to be attached.
2. A device of claim 1 wherein the locking means is a pair of threaded clamp bolts, each clamp bolt of which locks into threads in an articulating clamp and into threads in one of said bone screws.
3. A device of claim 2 wherein the bone screws are made of stainless steel and are further adapted to be screwed not only into a pedicle but also into the body of a vertebra.
4. A device of claim 3 wherein the bone screws are tapered each at their distal-most portion for ease of insertion.
5. A device of claim 4 wherein the first and second bone screws each has self-tapping threads at its distal-most portion.
6. A device according to claim 1, wherein said rigid stabilizing rod has a length which is adapted to span about at most only three vertebrae.
7. A device according to claim 1, wherein said rigid stabilizing rod has a length which is adapted to span about at most only two vertebrae.
8. A combination comprising a device according to claim 1 to be placed onto a first side of the spinal column and another device according to claim 1 to be placed onto a second side of the spinal column.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US869387A | 1987-01-30 | 1987-01-30 | |
| US8,693 | 1987-01-30 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1318203C true CA1318203C (en) | 1993-05-25 |
Family
ID=21733130
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA 557556 Expired - Fee Related CA1318203C (en) | 1987-01-30 | 1988-01-28 | Spinal fixation device |
Country Status (1)
| Country | Link |
|---|---|
| CA (1) | CA1318203C (en) |
-
1988
- 1988-01-28 CA CA 557556 patent/CA1318203C/en not_active Expired - Fee Related
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| MKLA | Lapsed |