The present disclosure relates generally to bone fixation assemblies, and more particularly to screw and rod fixation assemblies featuring two step locking mechanisms that provide a compact design and allow the use of smaller and less invasive instrumentation.
Surgeons who perform spinal stabilization procedures using pedicle screw systems typically require a mechanism for manipulating the spinal anatomy prior to tightening or locking the pedicle screw system. Manipulation is commonly performed as a distraction or compression of the vertebral disc space. Vertebral body reduction can also be needed, depending on the condition being treated. Manipulation can be carried out with instrumentation that acts on the pedicle screw.
Surgeons often use polyaxial screws to manipulate the spine. Polyaxial screws, which are defined herein as screws that are rotatable about multiple axes of rotation relative to a receiver body, are often chosen because the polyaxicity of the screws provides maneuverability that allows the stabilization construct to be positionally adjusted in multiple directions. The maneuverability of polyaxial screws can be problematic, however, because the freedom of motion can interfere with attempts to apply compression, distraction or reduction. Monoaxial screws, which are defined herein as screws that are rotatable about one and only one axis of rotation relative to a receiver body, are an alternative that avoids the problems associated with polyaxicity. Nevertheless, there is still a large preference for polyaxial screws. Therefore, there is a need for a pedicle screw assembly that allows for the advantages of polyaxial screws while controlling undesired maneuverability of polyaxial screws.
The drawbacks of conventional screw assemblies are addressed by locking screw assemblies and methods of using locking screw assemblies in accordance with the invention. In one embodiment, a two step locking screw assembly includes a receiving member for receiving a fixation member and an anchor having an enlarged portion and a shank. The enlarged portion of the anchor may be seated in the receiving member. An insert may also extend inside the receiving member. An outer fastener may be positioned in the receiving member. The outer fastener may include a central opening and a pair of ramped flanges. An inner fastener may be disposed inside the central opening of the outer fastener.
In another embodiment, a two step locking screw assembly may include a receiving member for receiving a fixation member. The receiving member may include a tubular body with a first end, a second end, and a tubular wall extending between the first and second ends. The tubular wall may, include an opening in the second end. The tubular wall may also form a passage between the first and second ends. In addition, the tubular wall may form a pair of grooves diametrically opposed to one another inside the tubular body. The assembly may also include an anchor in the form of a polyaxial screw. The screw may include a shank and an enlarged portion in the form of a head. The head may be seated in the passage adjacent the second end. The shank may extend through the opening in the second end. An insert may extend inside the receiving member in the passage. The assembly may include an outer fastener. The outer fastener may have a tubular body that forms a central opening and a pair of ramped flanges diametrically opposed to one another. The ramped flanges may be slidably displaceable into the pair of grooves in the tubular wall. An inner fastener may be disposed inside the central opening of the outer fastener.
In another embodiment, a method can be used to lock a fixation member, such as a fixation rod, inside a screw assembly. The method may include the steps of inserting an insert into a passage in a receiving member. A fixation rod may be inserted through the passage and into a U-shaped channel of the insert. An outer fastener may also be inserted into the passage. An inner fastener may be inserted into the outer fastener. The outer fastener may be rotated until ramped flanges on the outer fastener align with and slide into grooves in the receiving member to drive the outer fastener downwardly against the insert. The outer fastener may be driven downwardly to press the insert against a head of a polyaxial screw to immobilize the screw head in the seat. The inner fastener may be rotated inside the outer fastener to drive the inner fastener downwardly into engagement with the fixation rod. The inner fastener may be driven downwardly against the fixation rod to lock the rod in place in the screw assembly.
The detailed description that follows will be better understood in conjunction with the drawing figures, of which:
Although the invention is illustrated and described herein with reference to specific embodiments, the invention is not intended to be limited to the details shown. Rather, various modifications may be made in the details within the scope and range of equivalents of the claims and without departing from the invention.
In one embodiment, a two step locking screw assembly includes a receiving member for receiving a fixation member and a screw having a head and a shank. The head of the screw may be seated in the receiving member. An insert may also extend inside the receiving member. An outer fastener may be positioned in the receiving member. The outer fastener may include a central opening and a pair of ramped flanges. An inner fastener may be disposed inside the central opening of the outer fastener.
The receiving member may include an inner wall into which a pair of grooves are formed. The ramped flanges may be disposed in the grooves in slidable engagement. The outer fastener may include a tubular body having a circumference, with each ramped flange winding around a portion of the circumference and projecting radially outwardly from the tubular body. The tubular body may have a proximal end and a distal end. Each ramped flange extends axially toward the distal end as it winds around the circumference of the tubular body in a clockwise direction.
Each ramped flange may include a first end, a second end and an elongated flange body extending between the first end and the second end. The first end may be located closer to the distal end of the tubular body than the second end, and the second end may be located closer to the proximal end of the tubular body than the first end. The outer fastener may include an internal thread, and the inner fastener may include an external thread mated with the internal thread. The ramp flanges may extend around a portion of the internal thread and the external thread.
In another embodiment, a two step locking screw assembly may include a receiving member for receiving a fixation member. The receiving member may include a tubular body with a first end, a second end, and a tubular wall extending between the first and second ends. The tubular wall may include an opening in the second end. The tubular wall may form a passage between the first and second ends. The tubular wall may form a pair of grooves diametrically opposed to one another inside the tubular body. The assembly may also include a polyaxial screw. The screw may include a head and a shank. The head may be seated in the passage adjacent the second end. The shank may extend through the opening in the second end. An insert may extend inside the receiving member in the passage.
The assembly may further include an outer fastener. The outer fastener may have a tubular body that forms a central opening and a pair of ramped flanges diametrically opposed to one another. The ramped flanges may be slidably displaceable into the pair of grooves in the tubular wall. An inner fastener may be disposed inside the central opening of the outer fastener.
The receiving member may include a midsection between the first and second ends of the receiving member. The first end of the receiving member may include a flange extending radially outwardly from the first end. The flange may include an outer diameter less than the maximum outer diameter of the midsection. The flange and midsection may be separated from one another by a reduced diameter section forming a groove between the flange and midsection. The maximum outer diameter of the reduced diameter section may be less than the maximum outer diameter of the flange.
The ramped flanges may be disposed in the grooves inside the receiving member in slidable engagement. The tubular body of the outer fastener may include a circumference, with each ramped flange winding around a portion of the circumference and projecting radially outwardly from the tubular body of the outer fastener. The outer fastener may include a proximal end and a distal end. Each ramped flange may extend axially toward the distal end of the outer fastener as the ramped flange winds around the circumference of the outer fastener in a clockwise direction.
Each ramped flange may include a first end, a second end and an elongated flange body extending between the first end and the second end of said ramped flange. The first end of each ramped flange is located closer to the distal end of the outer fastener than the second end, and the second end is located closer to the proximal end of the tubular body than the first end. The outer fastener may include an internal thread, and the inner fastener may include an external thread mated with the internal thread. The ramp flanges may extend around a portion of the internal thread and the external thread.
In another embodiment, a method can be used to lock a fixation member, such as a fixation rod, inside a screw assembly. The method may be performed using a screw assembly that includes a receiving member having a tubular body with a first end, a second end, and a tubular wall extending between the first and second ends. The tubular wall may form a passage between the first and second ends.
The tubular wall may form a pair of grooves diametrically opposed to one another inside the tubular body. The screw assembly may also include a polyaxial screw having a head and a shank. The head may be seated in the passage adjacent the second end. The shank may extend through an opening in the second end. The screw assembly may further include an insert having a U-shaped channel. The insert may be configured for placement inside the receiving member in the passage.
The screw assembly may also include an outer fastener having a body that forms a central opening and a pair of ramped flanges diametrically opposed to one another. The ramped flanges may be configured for slidable displacement into the pair of grooves in the tubular wall. The screw assembly may additionally include an inner fastener configured for placement inside the central opening of the outer fastener. The method may include the steps of:
inserting the insert into the passage;
inserting a fixation rod through the passage and into the U-shaped channel of the insert;
inserting the outer fastener into the passage;
inserting the inner fastener into the outer fastener;
rotating the outer fastener until the ramped flanges align with and slide into the grooves in the tubular wall to drive the outer fastener downwardly against the insert;
driving the outer fastener downwardly to press the insert against the head of the polyaxial screw to immobilize the screw head in the seat;
rotating the inner fastener inside the outer fastener to drive the inner fastener downwardly into engagement with the fixation rod; and driving the inner fastener downwardly against the fixation rod to lock the rod in place in the screw assembly.
Referring to
Tubular body 211 has a U-shaped construct, sometimes referred to as a “tulip” or “saddle”. The U-shaped construct is defined by a pair of parallel extensions 220 that are generally parallel to longitudinal axis L1. Extensions 220 are separated from one another by an elongated passage 218 that extends from the proximal end 212 to the distal end 214 of receiving member 210. Extensions 220 are also separated from one another by a pair of diametrically opposed slots 219 that extend parallel to the longitudinal axis L1 of tubular body 211. Screw 250 has a frustospherical head 252 configured for polyaxial movement in tubular body 211. In addition, distal end 214 has a hole 217 that extends through the distal end. The diameter of hole 217 is greater than the diameter of the shank 254 but less than the maximum dimension of the screw head 252. In this arrangement, the diameter of shank 254 is small enough to pass through hole 217, while the diameter of head 252 is too large to pass through the hole, so that the head is retained in the receiving member 210. Distal end 214 of receiving member 210 forms a rounded seat 215 inside the receiving member. Head 252 bears against seat 215 and is displaceable in receiving member 210 through a polyaxial range of motion.
Screw assembly 200 also includes an insert 260. In the assembled state, insert 260 is positioned beneath rod 300 between the rod and screw head 252. Insert 260 has a U-shaped construct, similar to the receiving member 210. The U-shaped construct is defined by a proximal end 262, a distal end 264 and a tubular body 266 extending between the proximal end and the distal end. Tubular body 266 defines a longitudinal axis L2. Longitudinal axis L2 is preferably coaxial with longitudinal axis L1 when the components are assembled together. A pair of extensions 268 extend generally parallel to longitudinal axis L2. Extensions 268 are separated from one another by an elongated passage 261 and a pair of slots 263. Slots 263 are designed to receive and support rod 300 in a cradled arrangement as shown in
As noted above, screw assembly 200 is a “two step” locking assembly. A first locking mechanism is deployable to immobilize or “lock down” the polyaxial screw. Once the polyaxial screw is locked down, the orientation of the polyaxial screw is fixed relative to receiving member 210, so that the polyaxial screw can no longer move polyaxially. When first locking mechanisms are deployed in two adjacent screw assemblies 200 to lock down the polyaxial screws, it is easier to apply compression and distraction to the disc space between the adjacent screw assemblies, because the polyaxicity of the screws is restricted and cannot interfere with the compression or distraction. A second locking mechanism is deployable to lock down the fixation rod 300 in receiving member 210.
The first locking mechanism is provided by an outer fastener 270. Outer fastener 270 includes a proximal end 272, a distal end 274 and a tubular body 276 extending between the proximal and distal ends. Tubular body 276 forms a central opening 278 with an inner engagement surface in the form of an internal thread 279. In addition, tubular body 276 includes an outer engagement surface in the form of a pair of ramped flanges 271. Ramped flanges 271 are diametrically opposed to one another on the outer perimeter of tubular body 276, and are configured to mate with a pair of grooves 221 formed in tubular wall 216 of receiving member 210. Grooves 221 are formed in the parallel extensions 220 and are diametrically opposed to one another inside tubular body 211.
Tubular body 276 of outer fastener 270 has a circumference represented by arc shaped arrows 270a in
When the components are assembled as shown in
Proximal end 272 of outer fastener 270 includes a rim 275 extending around the circumference of the proximal end. Four notches 277 are formed in rim 275, the notches uniformly spaced around the rim at ninety degree intervals as shown. Notches 277 are adapted to couple with a driver tool (not shown).
The second locking mechanism is provided by an inner fastener 280. Inner fastener 280 includes a proximal end 282, a distal end 284 and a body 286 extending between the proximal and distal ends. Proximal end 282 is open and distal end 284 is closed, the closed distal end forming a distal bearing surface 285. Body 286 surrounds a central opening 288 with an inner engagement surface in the form of a hexagonal socket 289. In addition, tubular body 286 includes an outer engagement surface in the form of an external thread 281. External thread 281 is configured to mate with internal thread 279 in outer fastener 270 to allow inner fastener 280 to be advanced into central opening 278 of the outer fastener.
When inner fastener 280 is threaded into outer fastener 270, the inner and outer fasteners may be rotatable in unison to begin a two-step locking process. The torque required to rotate inner fastener 280 inside outer fastener 270 is significantly greater than the torque required to rotate the outer fastener in the grooves 221 of receiving member 210. That is, the friction between the threads on the inner fastener 280 and outer fastener 270 provides greater resistance to torque than the surfaces contacting one another between the outer fastener 270 and receiving member 210. Torque applied to the inner fastener 280 nested inside the outer fastener 270 rotates both fasteners in receiving member 210 until ramped flanges 271 contact an end wall in grooves 221. At this point, the outer fastener 270 presses downwardly against insert 260 to lock down the screw 250 relative to the receiving member 210, as described above. The outer fastener 270 also “bottoms out” in the grooves, preventing any further rotation of the outer fastener relative to receiving member 210. Additional torque applied to the inner fastener 280 overcomes the frictional resistance between the threads on the inner fastener and outer fastener 270, and rotates the inner fastener relative to outer fastener to drive the inner fastener downwardly until bearing surface 285 engages rod 300. Once inner fastener 280 is advanced downwardly against rod 300, the rod is locked in place relative to the receiving member 210.
Outer fasteners in accordance with the invention, like outer fastener 270, are preferably designed to avoid the use of a threaded engagement between the outer fastener and the inner wall of the receiving member. This allows the outer fastener to have a non-uniform outer diameter, and in particular, a reduced diameter portion. The absence of threads between the outer fastener and receiving member also allows the receiving member to have a narrow wall thickness around the proximal end of the receiving member where the outer fastener engages the receiving member. These allowances permit the proximal end of the receiving member to have a compact design, which in turn, allows for smaller and less invasive instruments to be attached to the receiving member.
Outer fastener 270 and receiving member 210 embody examples of a compact design in accordance with the invention. Referring to
While preferred embodiments of the invention have been shown and described herein, it will be understood that such embodiments are provided by way of example only. Numerous variations, changes and substitutions will occur to those skilled in the art without departing from the spirit of the invention. Accordingly, it is intended that the appended claims cover all such variations as fall within the scope of the invention.
This application claims the benefit of priority of U.S. Application Ser. No. 61/524,116, filed Aug. 16, 2011, the contents of which is incorporated by reference herein in its entirety and for all purposes.
Number | Name | Date | Kind |
---|---|---|---|
6077262 | Schlapfer et al. | Jun 2000 | A |
6755829 | Bono et al. | Jun 2004 | B1 |
6786903 | Lin | Sep 2004 | B2 |
6896677 | Lin | May 2005 | B1 |
7081117 | Bono | Jul 2006 | B2 |
7780703 | Yuan | Aug 2010 | B2 |
7780704 | Markworth | Aug 2010 | B2 |
7785354 | Biedermann | Aug 2010 | B2 |
7785356 | Biedermann | Aug 2010 | B2 |
7789895 | Heinz | Sep 2010 | B2 |
7789896 | Jackson | Sep 2010 | B2 |
7789900 | Levy | Sep 2010 | B2 |
7794476 | Wisnewski | Sep 2010 | B2 |
7794477 | Melkent | Sep 2010 | B2 |
7819901 | Yuan et al. | Oct 2010 | B2 |
7967850 | Jackson | Jun 2011 | B2 |
8048124 | Chin et al. | Nov 2011 | B2 |
8062340 | Berrevoets et al. | Nov 2011 | B2 |
8162989 | Khalili | Apr 2012 | B2 |
8221472 | Peterson et al. | Jul 2012 | B2 |
8343191 | Matthis et al. | Jan 2013 | B2 |
8465528 | Schumacher | Jun 2013 | B2 |
8690925 | Biedermann et al. | Apr 2014 | B2 |
20020143341 | Biedermann et al. | Oct 2002 | A1 |
20040162560 | Raynor | Aug 2004 | A1 |
20040167525 | Jackson | Aug 2004 | A1 |
20040193160 | Richelsoph | Sep 2004 | A1 |
20060149233 | Richelsoph | Jul 2006 | A1 |
20060149241 | Richelsoph | Jul 2006 | A1 |
20060161152 | Ensign et al. | Jul 2006 | A1 |
20070260246 | Biedermann | Nov 2007 | A1 |
20080021473 | Butler et al. | Jan 2008 | A1 |
20080058811 | Alleyne | Mar 2008 | A1 |
20080086131 | Daly | Apr 2008 | A1 |
20080086132 | Biedermann | Apr 2008 | A1 |
20080086138 | Stone | Apr 2008 | A1 |
20080114362 | Justis | May 2008 | A1 |
20080114400 | Dant | May 2008 | A1 |
20080125788 | Cohen | May 2008 | A1 |
20080140121 | McLeer | Jun 2008 | A1 |
20080147121 | Justis | Jun 2008 | A1 |
20080147122 | Jackson | Jun 2008 | A1 |
20080154308 | Sherman | Jun 2008 | A1 |
20080215100 | Matthis et al. | Sep 2008 | A1 |
20080294202 | Peterson et al. | Nov 2008 | A1 |
20090163962 | Dauster | Jun 2009 | A1 |
20090216280 | Hutchinson | Aug 2009 | A1 |
20090318969 | Matthis et al. | Dec 2009 | A1 |
20100152785 | Forton et al. | Jun 2010 | A1 |
20100234891 | Freeman | Sep 2010 | A1 |
20100241170 | Cammisa | Sep 2010 | A1 |
20100241171 | Clement | Sep 2010 | A1 |
20110046683 | Biedermann et al. | Feb 2011 | A1 |
20110218579 | Jackson | Sep 2011 | A1 |
20130023935 | Pham et al. | Jan 2013 | A1 |
20130066380 | Haskins et al. | Mar 2013 | A1 |
20130090693 | Strausbaugh et al. | Apr 2013 | A1 |
Number | Date | Country |
---|---|---|
WO 0152758 | Jul 2001 | WO |
Entry |
---|
U.S. Appl. No. 11/961,379, Non Final Office Action mailed Oct. 17, 2012. |
“DI Independent Locking Technology”, DePuy Spine, Jan. 2006. |
Number | Date | Country | |
---|---|---|---|
20130066380 A1 | Mar 2013 | US |
Number | Date | Country | |
---|---|---|---|
61524116 | Aug 2011 | US |