The present invention relates generally to a driver apparatus for a pedicle screw assembly for providing an anchor point to a spinal segment for spinal fusion surgery.
In one embodiment a driver apparatus for a pedicle screw assembly is provided. The pedicle screw assembly includes a pedicle screw and a connector housing mounted on the pedicle screw. The driver apparatus includes an elongated driver housing having a proximal housing end and a distal housing end. The distal housing end includes a screw drive head configured for engaging the pedicle screw so that the pedicle screw can be rotated by rotating the driver housing. The driver housing has a first laterally open window located adjacent the proximal housing end, and has a second laterally open window located adjacent the distal housing end. The driver housing has a longitudinal housing passage defined therein communicating the first and second laterally open windows. A release shaft extends through the longitudinal housing passage. The shaft has a knob attached to a proximal end portion of the shaft and has a release thread defined on the distal end portion of the shaft. The knob is received in and accessible through the first laterally open window. The release thread is received in and accessible through the second laterally open window. The release shaft is rotatable within the driver housing. The driver housing includes a guide surface extending from the second laterally open window distally toward the screw drive head. The guide surface is configured to hold the connector housing of the pedicle screw assembly against rotation relative to the driver housing when the release shaft is rotated relative to the driver housing to disconnect the release thread from the connector housing of the pedicle screw assembly.
In another embodiment a pedicle screw installation system includes a pedicle screw assembly and a driver apparatus. The pedicle screw assembly includes a pedicle screw and a connector housing mounted on the pedicle screw. The pedicle screw includes an enlarged ball end. The connector housing has a lower seat receiving the ball end with the screw extending downward through a lower opening of the connector housing. The connector housing has two upwardly extending arms having internal threads defined on the arms. The connector housing has a slot dividing the two arms. The driver apparatus includes an elongated driver housing including a screw drive head defined on a lower end of the driver housing. The screw drive head is configured for engaging the ball end of the pedicle screw so that the pedicle screw can be rotated by rotating the driver housing. The driver housing has an upper laterally open window and a lower laterally open window. The driver housing has a longitudinal passage defined therein communicating the upper and lower laterally open windows. The driver housing includes first and second longitudinally extending guide surfaces on opposite sides of the lower laterally open window. The guide surfaces are configured to be received in the slot of the connector housing so that the connector housing may move longitudinally but not rotationally relative to the driver housing when the guide surfaces are received in the slot of the connector housing. The driver apparatus further includes a release shaft extending through the longitudinal housing passage. The shaft has a knob attached to the shaft. The knob is received in and accessible through the upper laterally open window. The shaft has a release thread defined on the shaft and extending laterally through the lower laterally open window. The release thread is configured to be threadedly engaged with the internal threads of the two arms of the connector housing. The release shaft is rotatable within the driver housing to selectively engage or disengage the release threads from the internal threads of the arms of the connector housing to connect or disconnect the driver from the pedicle screw assembly.
In another embodiment a method of installing a pedicle screw assembly in a patient comprises:
(a) providing a driver having a driver housing and having a release shaft rotatably received in the driver housing;
(b) providing the pedicle screw assembly including a pedicle screw and a connector housing, the connector housing having two upwardly extending arms with a slot between the arms;
(c) inserting a guide portion of a lower end of the driver housing into the slot of the connector housing;
(d) making up a threaded engagement of a release thread of the release shaft with internal threads of the upwardly extending arms of the connector housing;
(e) during step (d), advancing the guide portion of the lower end of the driver housing into the slot while preventing rotation of the connector housing relative to the driver housing, and forcing a drive head on a lower end of the driver housing into engagement with the pedicle screw; and
(f) substantially circumferentially enclosing the release threads within the arms of the connector housing and the guide portion of the driver housing.
In any of the above embodiments the driver apparatus may further include an elongated spool handle rotatably received about the driver housing.
In any of the above embodiments the first laterally open window may be located in an enlarged diameter portion of the driver housing.
In any of the above embodiments the knob may protrude through the first laterally open window on two diametrically opposed sides of the driver housing so that the knob can be grasped between the thumb and forefingers of the human hand.
In any of the above embodiments the driver housing may comprise a multi-part housing assembly including a tubular central housing portion having a proximal end and a distal end. An enlarged diameter knob housing portion may be attached to the proximal end of the central housing portion and has the first laterally open window defined therein. A distal housing portion may be attached to the distal end of the central housing portion and has the second laterally open window defined therein.
In any of the above embodiments the guide surface may comprise first and second diametrically opposed parallel guide surface portions on opposite sides of the lower laterally open window.
In any of the above embodiments the axially overlapping portions of the driver housing and the upward extending arms of the connector housing may substantially enclose the release threads to shield the release threads from engagement with a patient's body tissue as the pedicle screw is inserted into the patient's body.
In any of the above embodiments, the engagement of the driver apparatus with the pedicle screw assembly may place a tension load across the connector housing between the pedicle screw and the internal threads of the arms of the connector housing, thereby holding the pedicle screw and the connector housing in axial alignment with the driver so as to resist misalignment of the pedicle screw and the connector housing during the application of driving torque to the pedicle screw by the driver.
Numerous objects features and advantages of the present invention will be readily apparent to those skilled in the art upon a reading of the following disclosure when taken in conjunction with the accompanying drawings.
Referring now to
Each of the pedicle screw assemblies 10 includes an elongated screw 14 having an enlarged ball end 16, an upper housing part 18 and a lower housing part 20, a sleeve 22, an annular wave spring 24, and an upper nut 26. The housing 18, 20 is sometimes referred to as a tulip housing or connector housing.
The enlarged ball end 16 has a multi-lobed socket 17 formed in the upper end thereof for engagement with a drive head of the driver apparatus 100 as further described below.
As seen in
As best seen in
The lower housing part 20 seen in
The lower end of upper housing part 18 has an external thread 48 which is received within an internal thread 50 of the upper end of lower housing part 20 so that the upper housing part 18 and the lower housing part 20 may be threadedly connected together by threads 48, 50.
The sleeve 22 has a lower larger diameter end portion 52 received in the counterbore 32 of the upper housing part 18. The sleeve 22 further has an upper smaller diameter end portion 54 which is received in the bore 30 of the upper housing part 18 as seen in
The annular wave spring 24 is disposed concentrically about the upper smaller diameter end portion 54 of the sleeve 22 and as seen in
The upper seat 58 may have scribe lines or grooves 62 therein. The ball end 16 may have scribe lines or grooves 66 defined therein. The use of the scribe lines or grooves 62 and 66, in any desired combination, increases friction between the seats and the ball end.
The upward extending arms 36 and 38 of the upper housing part 18 have internal threads 68 and 70 defined thereon. The upper nut 26 has a matching external thread 72 for receipt within the internal threads 68 and 70. The threads 68, 70 and 72 may for example be in the form of a single sided dove-tail threadform.
As best seen in
The purpose of the annular wave spring 24 is to provide a pre-load on the sleeve 22 thus providing a pre-load sandwiching the ball end 16 between the upper and lower seats 58 and 46. This provides a frictional resistance of the housing assembly 18, 20 relative to the pedicle screw 14. The surgeon may rotate the housing assembly to a desired orientation relative to the pedicle screw 14 and the housing assembly will generally stay in place as the elongated rod 28 is placed therethrough. This allows the surgeon to assemble the spinal reinforcing structure made up of a plurality of the pedicle screw assemblies 10 and a plurality of the elongated rods 28 and associated cross-pieces (not shown).
The construction of the annular wave spring 24 is best seen in
In one embodiment, the spring 24 may comprise slightly less than two complete coils, with the coil ends being separated by a gap 84. This can be described as comprising at least 1-½ complete coils. In one example, such a spring may be made from grade 2 titanium wire having a wire width 76 of 0.81 mm and a wire thickness 78 of 0.25 mm. The spring may have an outside diameter 82 slightly less than 9 mm in order to fit within a 9 mm bore. The wave pattern may provide 3-1/2 waves for each 360° coil of the spring. The spring may have a free height 86 as seen in
An annular wave spring 24 of the type just described provides a uniform application of force around the ball end 16 thus providing for smooth and reliable operation of the spring 24 to achieve its purpose of providing a reliable pre-load on the ball end 16 for holding the connector housing assembly in place relative to the ball end 16. This may be referred to as a pre-clamping frictional engagement between the seats and the ball end to hold the seats in a selected position relative to the ball end. Thus the annular wave spring is configured to apply a concentrically uniform pre-clamping load to the assembled first and second seats 58 and 46 and the ball end 16.
The pedicle screw assembly 10 is preferably pre-assembled by the manufacturer to include at least those components illustrated in the exploded view of
The elongated screw 14 having the ball end 16 is placed through the open lower end 44 of lower housing part 20 and is engaged with lower seat 46. The spring 24 is placed about the upper smaller diameter portion 54 of sleeve 22, and the sleeve 22 is placed in engagement with the bore 30 and counterbore 32 of the upper housing part 18.
The upper and lower housing parts 18 and 20 are threadedly connected together by threads 48 and 50 thus assembling the elongated screw between the first and second seats, and pre-loading the seats toward each other with the annular wave spring 24 to provide a pre-clamping frictional engagement of the ball end 16 with the seats 58 and 46 so that the housing assembly 18, 20 containing the seats 58, 46 will remain in a selected position relative to the ball end 16 prior to applying a final clamping force to the seats.
The upper nut 26 is provided for later insertion within the upper housing part 18. The nut may or may not be pre-assembled with the upper housing part 18 by the manufacturer.
After the pedicle screw assemblies are put in place within the vertebra 12 as shown in
Referring now to
The driver apparatus 100 includes an elongated driver housing 102 and a release shaft 104 received in the driver housing 102.
The driver housing 102 is preferably a multi-part housing assembly including a tubular central driver housing portion 106, an upper driver housing portion 108, and a lower driver housing portion 110.
The central driver housing portion 106 includes upper and lower ends 112 and 114 which may also be referred to as proximal and distal ends 112 and 114.
The central driver housing portion 106 includes a larger diameter upper part 116 and a smaller diameter lower part 118 separated by an annular shoulder 120.
The upper driver housing portion 108 may also be referred to as an enlarged diameter knob housing portion 108, and is threadedly connected to the upper end 112 of central driver housing portion 106 by threads 122 and an internal thread (not shown) on the lower end of upper driver housing portion 108. The upper driver housing portion 108 has a first laterally open window 124 defined therethrough.
The lower driver housing portion 110, which may also be referred to as a distal housing portion 110, is attached to the lower end 114 of the central driver housing portion 106 by thread 126 on the central driver housing portion 106 and internal thread 128 on the lower driver housing portion 110. The lower driver housing portion 110 has a second laterally open window 130 defined therethrough.
The lower driver housing portion 110 has a screw drive head 132 defined thereon which has a multi-lobed shaped male driver configured to be received in a multi-lobed socket 17 defined in the upper end of the enlarged ball 16 of pedicle screw 14.
The central driver housing portion 106 has a longitudinal housing passage 134 defined therethrough which communicates with the upper laterally open window 124 and the lower laterally open window 130.
The release shaft 104 has a knob 136 attached to the upper end thereof. Knob 136 has a non-circular passage 138 which closely receives a non-circular upper portion 140 of the release shaft 104 so that the release shaft 104 and the knob 136 rotate together. As is best seen in
The release shaft 104 has a release thread 142 defined on a lower end portion of the shaft 104. The release thread 142 is received in and accessible through the lower laterally open window 130 as best seen in
The release shaft 104 and knob 136 are rotatably received in the driver housing 102 so that the release thread 142 may be rotated by rotating the knob 136 while holding the driver housing 102 fixed.
An elongated spool handle 144 is best seen in
The upper driver housing portion 108 has a drive shaft 146 extending upwardly therefrom, and the drive shaft 146 has an upper drive head 148 defined thereon which may be engaged by the surgeon with another drive tool to rotate the driver housing 102 while the surgeon steadies the driver housing 102 by grasping the spool handle 144. The driver housing 102 can rotate within the spool handle 144.
The lower driver housing portion 110 has first and second diametrically opposed parallel guide surfaces or guide surface portions 150 and 152 defined thereon on opposite sides of the lower laterally open window 130. The guide surface portions 150 and 152 are separated by a distance 154 which is less than the width 41 of slot 40 of the upper connector housing part 18 of the pedicle screw assembly 10. That portion of the lower driver housing 110 between the guide surfaces 150 and 152 may be referred to as a guide portion 155.
As seen in
As best seen in
Referring now to
After the spinal vertebrae 12 have been prepared in a known manner for placement of the pedicle screws 14, the driver apparatus 100 may be connected to one of the pedicle screw assemblies 10 in the manner illustrated in
It is noted that when the release thread 142 is fully made up with the internal threads 68, 70 of upper connector housing 18 as generally shown in
It is noted that by substantially circumferentially enclosing the release thread 142 the release thread 142 is generally protected from contact with the patient's body tissues as the pedicle screw assembly 10 is placed by the driver apparatus 100 into the patient's body.
With reference to
After the pedicle screw assembly 10 has been attached to the lower end of the driver apparatus 100 as generally shown in
After the pedicle screw 14 has been driven into place within the spinal vertebra 12, the driver apparatus 100 may be released from the pedicle screw assembly 10 by unmaking the threaded engagement of the release thread 142 with the internal threads 68, 70 of the connector housing 18, 20. This is accomplished by holding the driver housing 102 fixed and rotating the release shaft and knob 136 counterclockwise relative to the driver housing 102 to unthread the release thread 102 from the connector housing 18, 20. The driver apparatus 100 is then withdrawn from the operating field.
At this point, the connector housing 18, 20 may be positioned by the surgeon in any desired rotational and angular relationship relative to the ball end 16, for example in positions like those shown in
Then, the elongated rods such as 28 may be placed in the slots 40 of a plurality of the pedicle screw assemblies 10, and then the elongated rods 28 may be clamped in place through the use of the upper nuts 26. The upper nuts 26 are placed in threaded engagement with the threads 68, 70 and are driven into place by another screwdriver (not shown) having a drive head which engages a socket 27 defined in the nut 26.
As the upper nut 26 is made up with the threads 68, 70 it bears down on the elongated rod 28 as seen in
Thus it is seen that the apparatus and methods of the present invention readily achieve the ends and advantages mentioned as well as those inherent therein. While certain preferred embodiments of the invention have been illustrated and described for purposes of the present disclosure, numerous changes in the arrangement and construction of parts and steps may be made by those skilled in the art, which changes are encompassed within the scope and spirit of the present invention as defined by the appended claims.
Filing Document | Filing Date | Country | Kind |
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PCT/US13/65074 | 10/15/2013 | WO | 00 |
Number | Date | Country | |
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61715612 | Oct 2012 | US |