WO1997014366A1 - Self-limiting set screw for use with spinal implant systems - Google Patents
Self-limiting set screw for use with spinal implant systems Download PDFInfo
- Publication number
- WO1997014366A1 WO1997014366A1 PCT/US1996/017283 US9617283W WO9714366A1 WO 1997014366 A1 WO1997014366 A1 WO 1997014366A1 US 9617283 W US9617283 W US 9617283W WO 9714366 A1 WO9714366 A1 WO 9714366A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- torque
- set screw
- screw
- spinal implant
- set forth
- Prior art date
Links
- 239000007943 implant Substances 0.000 title claims description 17
- 238000007906 compression Methods 0.000 claims abstract description 11
- 230000000399 orthopedic effect Effects 0.000 claims 4
- 239000002184 metal Substances 0.000 claims 1
- 230000006835 compression Effects 0.000 abstract description 8
- 238000010008 shearing Methods 0.000 abstract description 6
- 238000012360 testing method Methods 0.000 description 4
- 238000002513 implantation Methods 0.000 description 3
- 238000005259 measurement Methods 0.000 description 3
- 239000003381 stabilizer Substances 0.000 description 3
- 238000001356 surgical procedure Methods 0.000 description 3
- 239000000463 material Substances 0.000 description 2
- 229910001220 stainless steel Inorganic materials 0.000 description 2
- 239000010935 stainless steel Substances 0.000 description 2
- SUBDBMMJDZJVOS-UHFFFAOYSA-N 5-methoxy-2-{[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl}-1H-benzimidazole Chemical compound N=1C2=CC(OC)=CC=C2NC=1S(=O)CC1=NC=C(C)C(OC)=C1C SUBDBMMJDZJVOS-UHFFFAOYSA-N 0.000 description 1
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 description 1
- 238000004873 anchoring Methods 0.000 description 1
- 239000000560 biocompatible material Substances 0.000 description 1
- 230000005540 biological transmission Effects 0.000 description 1
- 210000001217 buttock Anatomy 0.000 description 1
- 239000002131 composite material Substances 0.000 description 1
- 229910003460 diamond Inorganic materials 0.000 description 1
- 239000010432 diamond Substances 0.000 description 1
- 230000004927 fusion Effects 0.000 description 1
- 238000003780 insertion Methods 0.000 description 1
- 230000037431 insertion Effects 0.000 description 1
- 230000007794 irritation Effects 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 229920003023 plastic Polymers 0.000 description 1
- 230000003068 static effect Effects 0.000 description 1
- 229910052719 titanium Inorganic materials 0.000 description 1
- 239000010936 titanium Substances 0.000 description 1
Classifications
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/03—Automatic limiting or abutting means, e.g. for safety
- A61B2090/037—Automatic limiting or abutting means, e.g. for safety with a frangible part, e.g. by reduced diameter
Definitions
- the invention relates generally to set screws for use with spinal implant systems, and more particularly to a set screw having a head for the external application of torque which will shear at a predetermined load.
- the set screw further includes an internal opening for receiv- ing a tool to permit the set screw to be removed.
- Spinal implant systems are used to strengthen, stabilize, and align the spine.
- Such systems often currently include an elongate stabilizer, such as a rod or plate; means to anchor the rod to a vertebra, such as a rod anchor, screw, or hook; and means to apply compression to the rod in order to hold it in place relative to the anchor.
- compression means include external compres- sion members (nuts or caps) and internal compression members (set screws or plugs) .
- the rod anchor may include a cap which twists or slides into position wherein a set screw is used to apply a compressive grip ⁇ ping force on the rod to hold it in position relative to the anchor.
- Some spinal systems include a closed anchor which encircles the rod wherein the set screw is used to lock the rod into position relative to the anchor. Set screws are also used to lock adjustable transverse links into position, and to lock the position of transversely adjustable rod-anchoring members.
- Spinal implant systems are designed with the object of being able to apply and withstand relatively high mechanical forces so as to hold the spine in align ⁇ ment while fusion takes place. However, it is also an object to provide a design which is as small as possible to provide minimal disruption to the biological environ- ment.
- implant systems are designed with the goal of quick and efficient implantation during surgery. Therefore, the implant components need to be easy to assemble and large enough to enable the surgeon to easily handle them. Also the components need to interface well with the instrumentation to facilitate implantation and assembly during surgery.
- the present invention therefore has an object of providing a set screw of a size which can be conveniently handled by the surgical staff during surgical implantation and which can be tightened to proper tightness without requiring the use of a torque wrench.
- the invention has the further object of provid- ing a means for the screw to be removed even after the head has been sheared from the screw. Therefore, the set screw in accordance with the present invention enables a surgeon to apply from about 50 to about 70 inch-pounds (6- 8 Newton-meters) of torque to tighten the screw prior to the self-limiting shearing of the head at a preset maximum torque value.
- the set screw enables from about 35 to about 50 inch-pounds of loosening torque.
- Figure 1 is a side view of the set screw in accordance with the invention.
- Figure 2 is a top view of the set screw;
- Figure 3 is a bottom view of the set screw;
- Figure 4 is a cross-section of the set screw of the invention taken generally along line 4-4 of Figure 2;
- Figure 5 is a view of the set screw in a rod anchor prior to shearing of the external torque-receiving hea ;
- Figure 6 is a view of the rod anchor and set screw after shearing.
- a set screw 5 in accordance with the invention is shown in Figure 1 having a first externally threaded screw portion 20 and an axially aligned external torque or tightening head 10 joined to the screw portion 20 by a necked shearing area 30.
- external torque head it is meant that the tightening torque is applied to the exter ⁇ nal surfaces of the head.
- the torque head 10 has a shape and size which facilitates handling by the surgeon and which enables the external application of torque to tighten the set screw relative to a rod anchor (shown at 60 in Figures 5 and 6) .
- Suitable cross-sectional shapes include triangular, square, pentagonal, hexagonal, octagonal, cross-shaped, and irregularly shaped configurations which would allow the transmission of a torquing force to the screw 5 to tighten it in place.
- the hexagonal cross-section is a particularly preferred shape.
- the external torque head or tightening head 10 is dimensioned so as to transmit a predetermined torque level, i.e., more than about 45 or 50 inch-pounds and preferably 55 to 65 inch-pounds.
- a predetermined torque level i.e., more than about 45 or 50 inch-pounds and preferably 55 to 65 inch-pounds.
- the amount of torque which can be applied to the head prior to shearing will depend on the material as well as the cross-sectional area of the neck.
- the head has an external diameter of from about 0.17 to about 0.25 inch, preferably from about 0.18 to about 0.20 inch and has a longitudinal length of from about 0.07 to about 0.17 inch, preferably from about 0.14 to about 0.16 inch.
- the head 10 has a dimension comparable to the external diameter of the threaded screw portion 20.
- the torque head 10 is illustrated in the drawings as having a hexago ⁇ nal external cross-section with a flat-to-flat measurement of about 0.12 to 0.25 inch and more specifically from about 0.14 to about 0.18 inch and with a point-to-point measurement of about 0.12 to about 0.25 inch with a preferred measurement of about 0.16 to about 0.19 inch.
- the threaded portion 20 has a longitudinal length of from about 0.1 to about 0.25, and more specifi ⁇ cally about 0.18 to about 0.20.
- the threaded portion 20 has an external outer diameter of about 0.19 inch, a minor diameter of about 0.15 inch, and a thread pitch of about 28 to about 36, e.g., 32, threads per inch.
- the thread configuration is a standard, V-shaped thread.
- the screw portion 20 termi- nates in a bevel portion 25 which forms an angle of from about 40° to about 50° with respect to the longitudinal axis of the set screw.
- the screw portion includes a high- compression end 27 which has a rough surface.
- the high-compression surface 25 includes a raised diamond knurl with a pitch of about 0.025 inch to increase the compressive grip on the rod.
- the high- compression surface 27 is circular with a diameter of from about 0.08 to about 0.12 inch.
- the beveled edge has a longitudinal length of from about 0.03 to about 0.06 inch, and preferably about 0.04 to about 0.05 inch.
- a torque- limiting area 30 is provided to limit the application of tightening torque in order to protect the threaded area 20. More specifically, the torque-limiting area 30 comprises a necked portion having a longitudinal length of about 0.03 to about 0.05 inch and having a groove or radiused area which is designed to cause the torque applicator head 10 to shear at a predetermined load which is between 50 and 70 inch-pounds, preferably from 54 to 64 inch-pounds, in order to eliminate the need for a torque wrench to measure the tightening.
- the necked area 30 is intended to shear evenly, i.e., in a way which will prevent an uneven break which could inhibit the insertion of a removal tool into the set screw or leave a jagged surface which could cause irritation to the pa ⁇ tient.
- the torque head has an internal bore 35 which extends through the necked area 30 and which has a diameter to provide a residual cross-section of the set screw in the necked area to provide the predetermined load limit.
- a suitable wall thickness is from about 0.015 to about 0.02 inch with an external diameter sized similarly to the minor diameter of the thread.
- the threaded set screw portion includes an internal torque opening 50, such as a hexagonal bore.
- the internal torque applicator opening 50 is designed to allow loosening torques up to approximately 50 inch-pounds which is sufficient for the tightening torques which can be achieved for the present invention.
- internal torque opening it is meant that the set screw has an opening which permits the internal application of a loosening torque.
- the internal opening 50 is intended to allow the application of a loosening torque that is approximately two-thirds of the tightening torque.
- the internal opening 50 of the torque head is illustrated as having a diameter slightly larger than the point-to-point distance of the hexagonal opening which can be achieved by manufac ⁇ turing the set screw with a hexagonal opening which is subsequently drilled at a longitudinal depth through the necked portion in order to increase and make radially uniform the opening in the applicator.
- the set screw of the present invention is illustrated in Figure 5 in a rod anchor 60 with the applicator head still in place, and in Figure 6 with a sheared applicator head.
- the set screw would be loaded into the socket of a screwdriver which would receive the applicator head in order to install the set screw in its location.
- the instrument would be designed to grasp and hold the sheared head in order to avoid the head dropping into a wound.
- the instrument may include means such as a spring-loaded C-clip which holds the set screw and which has a cavity into which the sheared head is transferred by a subse ⁇ quently installed torque head of a subsequent set screw.
- the surgeon can remove the set screw by seating a driver tool into the internal torque applicator opening, i.e., the internal hex, and reversing the direction of torque.
- the current invention increases the ease of removal of the set screw since the necked area inhibits the possibility of overtightening the screws and stripping the threads of the set screw.
- the set screw is made of a sufficiently hard biocompatible material such as, for example, hardened, surgical-grade stainless steel, e.g., 22-13-5 stainless steel.
- a sufficiently hard biocompatible material such as, for example, hardened, surgical-grade stainless steel, e.g., 22-13-5 stainless steel.
- Other appropriate materials such as titanium or biocompatible plastics or composites may be used with the appropriate revision to the prescribed predetermined load limit and rates of compression.
- a static axial slip test was performed using a closed rod anchor with both annealed and unannealed rods and shear head set screws in accordance with the inven ⁇ tion.
- the amount of load applied to cause 0.012 inch of axial slip was measured for four samples each of annealed rods and unannealed rods.
- the mean axial slip value was 376.4 pounds; the mean value of shear-off torque was 59 inch-pounds with a S.D. of 2 inch-pounds; and the set screw removal torque mean value was 42 inch-pounds with a S.D. of 4 inch-pounds. (This value was measured after the axial slip test and may have been effected by that test.)
- the axial slip failure load mean value was 342.5 pounds; the mean shear-off torque for these samples was 61 inch-pounds with a S.D. of 1 inch-pound; and the set screw removal torque mean value after axial slip was 35 inch-pounds with an S.D. of 2 inch-pounds.
Abstract
Description
Claims
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU75248/96A AU7524896A (en) | 1995-10-18 | 1996-10-16 | Self-limiting set screw for use with spinal implant systems |
EP96937785A EP0944360A1 (en) | 1995-10-18 | 1996-10-16 | Self-limiting set screw for use with spinal implant systems |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/544,884 | 1995-10-18 | ||
US08/544,884 US5697929A (en) | 1995-10-18 | 1995-10-18 | Self-limiting set screw for use with spinal implant systems |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1997014366A1 true WO1997014366A1 (en) | 1997-04-24 |
Family
ID=24174000
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US1996/017283 WO1997014366A1 (en) | 1995-10-18 | 1996-10-16 | Self-limiting set screw for use with spinal implant systems |
Country Status (4)
Country | Link |
---|---|
US (1) | US5697929A (en) |
EP (1) | EP0944360A1 (en) |
AU (1) | AU7524896A (en) |
WO (1) | WO1997014366A1 (en) |
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US7914559B2 (en) | 2006-05-30 | 2011-03-29 | Warsaw Orthopedic, Inc. | Locking device and method employing a posted member to control positioning of a stabilization member of a bone stabilization system |
US8852239B2 (en) | 2013-02-15 | 2014-10-07 | Roger P Jackson | Sagittal angle screw with integral shank and receiver |
US8870928B2 (en) | 2002-09-06 | 2014-10-28 | Roger P. Jackson | Helical guide and advancement flange with radially loaded lip |
US8911478B2 (en) | 2012-11-21 | 2014-12-16 | Roger P. Jackson | Splay control closure for open bone anchor |
US8926670B2 (en) | 2003-06-18 | 2015-01-06 | Roger P. Jackson | Polyaxial bone screw assembly |
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US9439683B2 (en) | 2007-01-26 | 2016-09-13 | Roger P Jackson | Dynamic stabilization member with molded connection |
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US10349983B2 (en) | 2003-05-22 | 2019-07-16 | Alphatec Spine, Inc. | Pivotal bone anchor assembly with biased bushing for pre-lock friction fit |
US8926670B2 (en) | 2003-06-18 | 2015-01-06 | Roger P. Jackson | Polyaxial bone screw assembly |
USRE46431E1 (en) | 2003-06-18 | 2017-06-13 | Roger P Jackson | Polyaxial bone anchor with helical capture connection, insert and dual locking assembly |
US8936623B2 (en) | 2003-06-18 | 2015-01-20 | Roger P. Jackson | Polyaxial bone screw assembly |
US9662143B2 (en) | 2004-02-27 | 2017-05-30 | Roger P Jackson | Dynamic fixation assemblies with inner core and outer coil-like member |
US9743957B2 (en) | 2004-11-10 | 2017-08-29 | Roger P. Jackson | Polyaxial bone screw with shank articulation pressure insert and method |
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US8926672B2 (en) | 2004-11-10 | 2015-01-06 | Roger P. Jackson | Splay control closure for open bone anchor |
US11147591B2 (en) | 2004-11-10 | 2021-10-19 | Roger P Jackson | Pivotal bone anchor receiver assembly with threaded closure |
US9522021B2 (en) | 2004-11-23 | 2016-12-20 | Roger P. Jackson | Polyaxial bone anchor with retainer with notch for mono-axial motion |
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US9308027B2 (en) | 2005-05-27 | 2016-04-12 | Roger P Jackson | Polyaxial bone screw with shank articulation pressure insert and method |
US7914559B2 (en) | 2006-05-30 | 2011-03-29 | Warsaw Orthopedic, Inc. | Locking device and method employing a posted member to control positioning of a stabilization member of a bone stabilization system |
WO2007143389A1 (en) * | 2006-05-30 | 2007-12-13 | Warsaw Orthopedic, Inc. | Locking device for a bone stabilization system |
US9439683B2 (en) | 2007-01-26 | 2016-09-13 | Roger P Jackson | Dynamic stabilization member with molded connection |
US9668771B2 (en) | 2009-06-15 | 2017-06-06 | Roger P Jackson | Soft stabilization assemblies with off-set connector |
US11229457B2 (en) | 2009-06-15 | 2022-01-25 | Roger P. Jackson | Pivotal bone anchor assembly with insert tool deployment |
US9717534B2 (en) | 2009-06-15 | 2017-08-01 | Roger P. Jackson | Polyaxial bone anchor with pop-on shank and friction fit retainer with low profile edge lock |
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US8911478B2 (en) | 2012-11-21 | 2014-12-16 | Roger P. Jackson | Splay control closure for open bone anchor |
US9770265B2 (en) | 2012-11-21 | 2017-09-26 | Roger P. Jackson | Splay control closure for open bone anchor |
US10058354B2 (en) | 2013-01-28 | 2018-08-28 | Roger P. Jackson | Pivotal bone anchor assembly with frictional shank head seating surfaces |
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Also Published As
Publication number | Publication date |
---|---|
AU7524896A (en) | 1997-05-07 |
EP0944360A1 (en) | 1999-09-29 |
US5697929A (en) | 1997-12-16 |
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