Funk, Michael J. (North Bend, WA, US)
Mcleer, Thomas J. (Redmond, WA, US)
Augostino, Teena M. (Redmond, WA, US)
Broman, Richard J. (Kirkland, WA, US)
Tokish Jr., Leonard J. (Issaquah, WA, US)

Plaque It! Sponsored by: Flash of Genius

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08/05/2008

09/26/2005

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Archus Orthopedics, Inc. (Redmond, WA, US)

606/97

33/512, 606/102

A61B17/90; A61B6/00

606/87, 606/130, 600/414, 606/102, 606/96, 378/205, 600/426, 606/86, 606/104, 33/512, 378/163, 606/97, 600/424

1308451		July, 1919	Schachat
2930133	Apparatus to aid in determining abnormal positions of spinal vertebrae	March, 1960	Thompson
2959861	Bevel protractor	November, 1960	Stromquist
3596656	FRACTURE FIXATION DEVICE	August, 1971	Kaute
3867728	Prosthesis for spinal repair	February, 1975	Stubstad et al.
3875595	INTERVERTEBRAL DISC PROSTHESIS AND INSTRUMENTS FOR LOCATING SAME	April, 1975	Froning
3941127	Apparatus and method for stereotaxic lateral extradural disc puncture	March, 1976	Froning	604/506
4040130	Wrist joint prosthesis	August, 1977	Laure
4123848	Block profile gauge	November, 1978	Emmerich et al.
4156296	Great (large) toe prosthesis and method of implanting	May, 1979	Johnson et al.
4210317	Apparatus for supporting and positioning the arm and shoulder	July, 1980	Spann et al.
4231121	Metacarpal-phalangeal prosthesis	November, 1980	Lewis
4271836	Appliance for correction of spinal curvatures	June, 1981	Bacal et al.
4349921	Intervertebral disc prosthesis	September, 1982	Kuntz
4394370	Bone graft material for osseous defects and method of making same	July, 1983	Jefferies
4472840	Method of inducing osseous formation by implanting bone graft material	September, 1984	Jefferies
4611581	Apparatus for straightening spinal columns	September, 1986	Steffee
4693722	Prosthetic temporomanibular condyle utilizing a prosthetic meniscus	September, 1987	Wall
4710075	Adjustable drill gauge	December, 1987	Davison
4759769	Artificial spinal disc	July, 1988	Hedman et al.
4772287	Prosthetic disc and method of implanting	September, 1988	Ray et al.
4778472	Implant for reconstruction of temporomanibular joint	October, 1988	Homsy et al.
4796637	Radiopaque marker for stereotaxic catheter	January, 1989	Mascuch et al.	600/435
4803976	Sighting instrument	February, 1989	Frigg et al.	606/97
4805602	Transpedicular screw and rod system	February, 1989	Puno et al.
4863477	Synthetic intervertebral disc prosthesis	September, 1989	Monson
4904260	Prosthetic disc containing therapeutic material	February, 1990	Ray et al.
4911718	Functional and biocompatible intervertebral disc spacer	March, 1990	Lee et al.
4917701	Temporomandibular joint prostheses	April, 1990	Morgan
4950270	Cannulated self-tapping bone screw	August, 1990	Bowman et al.
4955916	Thumb joint prosthesis	September, 1990	Carignan et al.
4987904	Method and apparatus for bone size gauging	January, 1991	Wilson
5000165	Lumbar spine rod fixation system	March, 1991	Watanabe
5015255	Spinal stabilization method	May, 1991	Kuslich
5019081	Laminectomy surgical process	May, 1991	Watanabe
5047055	Hydrogel intervertebral disc nucleus	September, 1991	Bao et al.
5062845	Method of making an intervertebral reamer	November, 1991	Kuslich et al.
5070623	Prosthetic gauge	December, 1991	Barnes
5071437	Artificial disc	December, 1991	Steffee
5092866	Flexible inter-vertebral stabilizer as well as process and apparatus for determining or verifying its tension before installation on the spinal column	March, 1992	Breard et al.
5108399	Device for osteosynthesis and process for producing it	April, 1992	Eitenmuller et al.
5129900	Spinal column retaining method and apparatus	July, 1992	Asher et al.
5147404	Vertebra prosthesis	September, 1992	Downey
5171280	Intervertebral prosthesis	December, 1992	Baumgartner
5192326	Hydrogel bead intervertebral disc nucleus	March, 1993	Bao et al.
5258031	Intervertebral disk arthroplasty	November, 1993	Salib et al.
5284655	Swollen demineralized bone particles, flowable osteogenic composition containing same and use of the composition in the repair of osseous defects	February, 1994	Bogdansky et al.
5300073	Sacral implant system	April, 1994	Ray et al.
5303480	Cranio-cervical sagittal-alignment caliper and universal measurement system	April, 1994	Chek
5306308	Intervertebral implant	April, 1994	Gross et al.
5306309	Spinal disk implant and implantation kit	April, 1994	Wagner et al.
5312409	Drill alignment guide	May, 1994	McLaughlin et al.
5314429	Method for forming a tunnel intersecting a straight cruciate ligament tunnel	May, 1994	Goble
5314476	Demineralized bone particles and flowable osteogenic composition containing same	May, 1994	Prewett et al.
5314486	Non-constrained total joint system	May, 1994	Zang et al.
5314492	Composite prosthesis	May, 1994	Hamilton et al.
5329933	Device for measuring the angle of movement of two vertebrae	July, 1994	Graf
5348026	Osteoinductive bone screw	September, 1994	Davidson
5350380	Method for securing a ligament replacement in a bone	September, 1994	Goble et al.
5370697	Artificial intervertebral disk member	December, 1994	Baumgartner
5401269	Intervertebral disc endoprosthesis	March, 1995	Buttner-Janz et al.
5405390	Osteogenic composition and implant containing same	April, 1995	O'Leary et al.
5415661	Implantable spinal assist device	May, 1995	Holmes
5425773	Intervertebral disk arthroplasty device	June, 1995	Boyd et al.
5437672	Spinal cord protection device	August, 1995	Alleyne
5445639	Intervertebral reamer construction	August, 1995	Kuslich et al.
5458641	Vertebral body prosthesis	October, 1995	Ramirez Jimenez
5458642	Synthetic intervertebral disc	October, 1995	Beer et al.
5458643	Artificial intervertebral disc	October, 1995	Oka et al.
5474551	Universal coupler for spinal fixation	December, 1995	Finn et al.
5474555	Spinal implant system	December, 1995	Puno et al.
5491882	Method of making joint prosthesis having PTFE cushion	February, 1996	Walston et al.
5501684	Osteosynthetic fixation device	March, 1996	Schlapfer et al.
5507823	Joint prosthesis having PTFE cushion	April, 1996	Walston et al.
5510396	Process for producing flowable osteogenic composition containing demineralized bone particles	April, 1996	Prewett et al.
5514180	Prosthetic intervertebral devices	May, 1996	Heggeness et al.
5527312	Facet screw anchor	June, 1996	Ray
5534028	Hydrogel intervertebral disc nucleus with diminished lateral bulging	July, 1996	Bao et al.
5534030	Spine disc	July, 1996	Navarro et al.
5545229	Functional and biocompatible intervertebral disc spacer containing elastomeric material of varying hardness	August, 1996	Parsons et al.
5556431	Intervertebral disc endoprosthesis	September, 1996	Buttner-Janz
5562738	Intervertebral disk arthroplasty device	October, 1996	Boyd et al.
5569247	Enhanced variable angle bone bolt	October, 1996	Morrison
5571189	Expandable fabric implant for stabilizing the spinal motion segment	November, 1996	Kuslich
5571191	Artificial facet joint	November, 1996	Fitz
5575792	Extending hook and polyaxial coupling element device for use with top loading rod fixation devices	November, 1996	Errico et al.
5577995	Spinal and soft tissue mobilizer	November, 1996	Walker et al.
5587695	Measuring transformer for solid-state electricity meters	December, 1996	Warmerdam
5603713	Anterior lumbar/cervical bicortical compression plate	February, 1997	Aust et al.
5609641	Tibial prosthesis	March, 1997	Johnson et al.
5643263	Spinal implant connection assembly	July, 1997	Simonson
5645597	Disc replacement method and apparatus	July, 1997	Krapiva
5649930	Orthopedic centering tool	July, 1997	Kertzner
5653762	Method of stabilizing adjacent vertebrae with rotating, lockable, middle-expanded intervertebral disk stabilizer	August, 1997	Pisharodi
5658338	Prosthetic modular bone fixation mantle and implant system	August, 1997	Tullos et al.
5662651	External or internal fixator for repairing fractures or arthroplasties of the skeleton	September, 1997	Tornier et al.
5674295	Prosthetic spinal disc nucleus	October, 1997	Ray et al.
5674296	Human spinal disc prosthesis	October, 1997	Bryan et al.
5676701	Low wear artificial spinal disc	October, 1997	Yuan et al.
5678317	Method for measuring labial/facial flaccidity	October, 1997	Stefanakos
5683391	Anterior spinal instrumentation and method for implantation and revision	November, 1997	Boyd
5683392	Multi-planar locking mechanism for bone fixation	November, 1997	Richelsoph et al.
5683464	Spinal disk implantation kit	November, 1997	Wagner et al.
5683466	Joint surface replacement system	November, 1997	Vitale
5688274	Spinal implant device having a single central rod and claw hooks	November, 1997	Errico et al.
5690630	Polyaxial pedicle screw	November, 1997	Errico et al.
5700268	Device for measuring leg length and off-set for a total hip replacement	December, 1997	Bertin
5702450	Intervertebral disk prosthesis	December, 1997	Bisserie
5704941	Tibial preparation apparatus and method	January, 1998	Jacober et al.
5716415	Spinal implant	February, 1998	Steffee
5725527	Anchoring member	March, 1998	Biedermann et al.
5728128	Femoral neck anteversion guide	March, 1998	Crickenberger et al.	606/97
5738585	Compact flexible couplings with inside diameter belt support and lock-on features	April, 1998	Hoyt, III et al.
5741255	Spinal column retaining apparatus	April, 1998	Krag et al.
5741261	Minimally invasive spinal surgical methods and instruments	April, 1998	Moskovitz et al.
5766253	Spinal fusion device	June, 1998	Brosnahan, III
5776135	Side mounted polyaxial pedicle screw	July, 1998	Errico et al.
5782833	Pedicle screw system for osteosynthesis	July, 1998	Haider
5792146	Rectilinear linac phantom pointer system	August, 1998	Cosman	606/130
5797911	Multi-axial bone screw assembly	August, 1998	Sherman et al.
5800433	Spinal column retaining apparatus	September, 1998	Benzel et al.
5824093	Prosthetic spinal disc nucleus	October, 1998	Ray et al.
5824094	Spinal disc	October, 1998	Serhan et al.
5827289	Inflatable device for use in surgical protocols relating to treatment of fractured or diseased bones	October, 1998	Reiley et al.
5836948	Spine distraction implant and method	November, 1998	Zucherman et al.
5860977	Spine distraction implant and method	January, 1999	Zucherman et al.
5863293	Spinal implant fixation assembly	January, 1999	Richelsoph
5865846	Human spinal disc prosthesis	February, 1999	Bryan et al.
5866113	Medical device with biomolecule-coated surface graft matrix	February, 1999	Hoensbroek et al.
5868745	Spinal protection device	February, 1999	Alleyne
5879350	Multi-axial bone screw assembly	March, 1999	Sherman et al.
5879396	Joint prosthesis having PTFE cushion	March, 1999	Walston et al.
5885285	Spinal implant connection assembly	March, 1999	Simonson
5885286	Multi-axial bone screw assembly	March, 1999	Sherman et al.
5891145	Multi-axial screw	April, 1999	Morrison et al.
5893889	Artificial disc	April, 1999	Harrington
RE36221	Flexible inter-vertebral stabilizer as well as process and apparatus for determining or verifying its tension before installation on the spinal column	June, 1999	Breard et al.
5947893	Method of making a porous prothesis with biodegradable coatings	September, 1999	Agrawal et al.
5951475	Methods and apparatus for registering CT-scan data to multiple fluoroscopic images	September, 1999	Gueziec et al.	600/425
5964760	Spinal implant fixation assembly	October, 1999	Richelsoph
6001130	Human spinal disc prosthesis with hinges	December, 1999	Bryan et al.
6010503	Locking mechanism	January, 2000	Richelsoph et al.
6014588	Facet joint pain relief method and apparatus	January, 2000	Fitz
6019759	Multi-Directional fasteners or attachment devices for spinal implant elements	February, 2000	Rogozinski
6019792	Articulating spinal implant	February, 2000	Cauthen
6022350	Bone fixing device, in particular for fixing to the sacrum during osteosynthesis of the backbone	February, 2000	Ganem
6036696	Guide-pin placement device and method of use	March, 2000	Lambrecht et al.	606/97
6039763	Articulating spinal disc prosthesis	March, 2000	Shelokov
6048342	Spine distraction implant	April, 2000	Zucherman et al.
6050997	Spinal fixation system	April, 2000	Mullane
6053917	Multi-axial bone screw assembly	April, 2000	Sherman et al.
6063121	Vertebral body prosthesis	May, 2000	Xavier et al.
6066325	Fragmented polymeric compositions and methods for their use	May, 2000	Wallace et al.
6068630	Spine distraction implant	May, 2000	Zucherman et al.
RE36758	Artificial facet joint	June, 2000	Fitz
6074391	Receiving part for a retaining component of a vertebral column implant	June, 2000	Metz-Stavenhagen et al.
6077262	Posterior spinal implant	June, 2000	Schläpfer et al.
6080157	Device to stabilize the lamina	June, 2000	Cathro et al.
6086590	Cable connector for orthopaedic rod	July, 2000	Margulies et al.
6090111	Device for securing spinal rods	July, 2000	Nichols
6113637	Artificial intervertebral joint permitting translational and rotational motion	September, 2000	Gill et al.
6120510	Cutting guide instrument	September, 2000	Albrektsson et al.
6132430	Spinal fixation system	October, 2000	Wagner
6132464	Vertebral joint facets prostheses	October, 2000	Martin
6132465	Tapered prosthetic spinal disc nucleus	October, 2000	Ray et al.
6165177	Alignment guide for insertion of stem prosthesis	December, 2000	Wilson et al.
6190388	Anterior spinal instrumentation and method for implantation and revision	February, 2001	Michelson et al.
6193724	Apparatus and method for determining the relative position of bones during surgery	February, 2001	Chan
6193758	Shoulder prosthesis	February, 2001	Huebner
6200322	Minimal exposure posterior spinal interbody instrumentation and technique	March, 2001	Branch et al.
6214012	Method and apparatus for delivering material to a desired location	April, 2001	Karpman et al.
6231575	Spinal column retainer	May, 2001	Krag
6248105	Device for connecting a longitudinal support with a pedicle screw	June, 2001	Schläpfer et al.
6280443	Spinal fixation system	August, 2001	Gu et al.
6290703	Device for fixing the sacral bone to adjacent vertebrae during osteosynthesis of the backbone	September, 2001	Ganem
6293949	Superelastic spinal stabilization system and method	September, 2001	Justis et al.
6302890	Pelvic alignment assembly	October, 2001	Leone, Jr.
6309391	Multidirectional pivoting bone screw and fixation system	October, 2001	Crandall et al.
6340361	External fixator clamp and system	January, 2002	Kraus et al.
6340477	Bone matrix composition and methods for making and using same	January, 2002	Anderson
6342054	Positioning and locking device	January, 2002	Mata
6361506	Incremental varus/valgus and flexion/extension measuring instrument	March, 2002	Saenger et al.
6368320	Connector for backbone osteosynthesis device	April, 2002	Le Couedic et al.
6371959	Radiolucent position locating device and drill guide	April, 2002	Trice	606/97
6419703	Prosthesis for the replacement of a posterior element of a vertebra	July, 2002	Fallin et al.
6451021	Polyaxial pedicle screw having a rotating locking element	September, 2002	Ralph et al.
6471705	Bone screw	October, 2002	Biedermann et al.
6514253	Apparatus for locating interlocking intramedullary nails	February, 2003	Yao
6520963	Vertebral alignment and fixation assembly	February, 2003	McKinley
6524315	Orthopaedic rod/plate locking mechanism	February, 2003	Selvitelli et al.
6540749	Bone screw	April, 2003	Schäfer et al.
6547790	Orthopaedic rod/plate locking mechanisms and surgical methods	April, 2003	Harkey, III et al.
6554843	Cataract instrument	April, 2003	Ou
6565565	Device for securing spinal rods	May, 2003	Yuan et al.
6565605	Multiple facet joint replacement	May, 2003	Goble et al.
6572617	Vertebra implant	June, 2003	Senegas
6579319	Facet joint replacement	June, 2003	Goble et al.
6585769	Artificial spinal ligament	July, 2003	Muhanna et al.
6610091	Facet arthroplasty devices and methods	August, 2003	Reiley
6623485	Split ring bone screw for a spinal fixation system	September, 2003	Doubler et al.
6632226	Apparatus and method for determining the relative position of bones during surgery	October, 2003	Chan
6638281	Gravity dependent pedicle screw tap hole guide	October, 2003	Gorek
6638321	Cationic oxidation bases, their use for oxidation dyeing of keratin fibres, dyeing compositions and dyeing methods	October, 2003	Genet et al.
6645214	Apparatus and method for bone positioning	November, 2003	Brown et al.
6648891	System and method for fusing spinal vertebrae	November, 2003	Kim
6669729	Apparatus and method for the replacement of posterior vertebral elements	December, 2003	Chin
6712818	Method for connecting adjacent vertebral bodies of a human spine with a plating system	March, 2004	Michelson
6712849	Apparatus and method for reconstructing a ligament	March, 2004	Re et al.
6749361	Shackle element for clamping a fixation rod, a method for making a shackle element, a hook with a shackle element and a rode connector with a shackle element	June, 2004	Hermann et al.
6761720	Intervertebral implant	July, 2004	Senegas
6770095	Intervertebral disc	August, 2004	Grinberg et al.
6783527	Flexible spinal stabilization system and method	August, 2004	Drewry et al.
6793678	Prosthetic intervertebral motion disc having dampening	September, 2004	Hawkins
6811567	Facet arthroplasty devices and methods	November, 2004	Reiley
6902580	Prosthesis for the replacement of a posterior element of a vertebra	June, 2005	Fallin et al.
6949123	Facet arthroplasty devices and methods	September, 2005	Reiley
6974478	Prostheses, systems and methods for replacement of natural facet joints with artificial facet joint surfaces	December, 2005	Reiley
6979299	Measuring guide for use in orthopedic procedure	December, 2005	Peabody et al.
7011658	Devices and methods for spinal compression and distraction	March, 2006	Young
7051451	Facet joint prosthesis measurement and implant tools	May, 2006	Augostino et al.
7294127	Electrosurgical tissue treatment method	November, 2007	Leung et al.	606/41
7302288	Tool position indicator	November, 2007	Schellenberg	600/427
20010012938	Spine distraction implant	August, 2001	Zucherman et al.
20010020170	Spinal implants, insertion instruments, and methods of use	September, 2001	Zucherman et al.
20020013585	Spinal implant for an osteosynthesis device	January, 2002	Gournay et al.
20020013588	Instrument and method for implanting an interbody fusion device	January, 2002	Landry et al.
20020029039	Supplemental spine fixation device and methods	March, 2002	Zucherman et al.
20020042613	Positioning and locking device	April, 2002	Mata
20020049446	Orthopaedic rod/plate locking mechanisms and surgical methods	April, 2002	Harkey, III et al.
20020065557	Facet joint replacement	May, 2002	Goble et al.
20020082601	Vertebra correcting and fixing device	June, 2002	Toyoma et al.
20020120272	Device for securing spinal rods	August, 2002	Yuan et al.
20020123806	Facet arthroplasty devices and methods	September, 2002	Reiley
20020151895	Method and device for treating scoliosis	October, 2002	Soboleski et al.
20030004572	Method and apparatus for spine joint replacement	January, 2003	Goble et al.
20030028250	Prostheses, systems and methods for replacement of natural facet joints with artifical facet joint surfaces	February, 2003	Reiley et al.
20030040797	Prosthesis for the replacement of a posterior element of a vertebra	February, 2003	Fallin et al.
20030125740	Laminoplasty fixation system	July, 2003	Khanna
20030181914	Coupling system and method for extending spinal instrumentation	September, 2003	Johnson et al.
20030191532	Facet joint replacement	October, 2003	Goble et al.
20030204259	Multiple facet joint replacement	October, 2003	Goble et al.
20040006391	Facet arthroplasty devices and methods	January, 2004	Reiley
20040015173	Extramedullary fluoroscopic alignment guide	January, 2004	Irving	606/88
20040049272	Facet arthroplasty devices and methods	March, 2004	Reiley
20040049273	Facet Arthroplasty devices and methods	March, 2004	Reiley
20040049274	Facet arthroplasty devices and methods	March, 2004	Reiley
20040049275	Facet arthroplasty devices and methods	March, 2004	Reiley
20040049276	Facet arthroplasty devices and methods	March, 2004	Reiley
20040049277	Facet arthroplasty devices and methods	March, 2004	Reiley
20040049278	Facet arthroplasty devices and methods	March, 2004	Reiley
20040049281	Facet arthroplasty devices and methods	March, 2004	Reiley
20040059429	Mechanically attached elastomeric cover for prosthesis	March, 2004	Amin et al.
20040111154	Facet arthroplasty devices and methods	June, 2004	Reiley
20040116927	Intervertebral stabilizing device	June, 2004	Graf
20040127989	Prosthetic facet joint ligament	July, 2004	Dooris et al.
20040143264	Metal-backed UHMWPE rod sleeve system preserving spinal motion	July, 2004	McAfee
20040167533	Radiolucent aiming guide	August, 2004	Wilson et al.	606/97
20040220567	Instruments and methods for aligning implants for insertion	November, 2004	Eisermann et al.	606/61
20040230201	Prostheses, tools and methods for replacement of natural facet joints with artifical facet joint surfaces	November, 2004	Yuan et al.
20040230304	Prostheses, tools and methods for replacement of natural facet joints with artifical facet joint surfaces	November, 2004	Yuan et al.
20040260305	Device for delivering an implant through an annular defect in an intervertebral disc	December, 2004	Gorensek et al.	606/99
20050010291	Prostheses, tools and methods for replacement of natural facet joints with artificial facet joint surfaces	January, 2005	Stinson et al.
20050015146	Posterior vertebral joint prosthesis	January, 2005	Louis et al.
20050027361	Facet arthroplasty devices and methods	February, 2005	Reiley
20050033434	Posterior elements motion restoring device	February, 2005	Berry
20050043799	Facet arthroplasty devices and methods	February, 2005	Reiley
20050049705	Facet implant	March, 2005	Hale et al.
20050055096	Functional spinal unit prosthetic	March, 2005	Serhan et al.
20050080428	Extracapsular surgical procedure for repair of anterior cruciate ligament rupture and surgical referencing instrument therefor	April, 2005	White
20050085912	Facet prosthesis	April, 2005	Amin et al.
20050102028	Spinal prostheses	May, 2005	Amin et al.
20050119748	Prostheses, systems and methods for replacement of natural facet joints with artificial facet joint surfaces	June, 2005	Reiley et al.
20050131406	Polyaxial adjustment of facet joint prostheses	June, 2005	Reiley et al.
20050137705	Facet arthroplasty devices and methods	June, 2005	Reiley
20050137706	Facet arthroplasty devices and methods	June, 2005	Reiley
20050143818	Prostheses, tools and methods for replacement of natural facet joints with artifical facet joint surfaces	June, 2005	Yuan et al.
20050149190	Facet arthroplasty devices and methods	July, 2005	Reiley
20050165484	Artificial disc replacement (ADR) fixation methods and apparatus	July, 2005	Ferree et al.
20050177175	Apparatus and method for aligning and positioning implants in a body	August, 2005	Johnstone	606/130
20050177240	Vertebral facet joint prosthesis and method of fixation	August, 2005	Blain
20050187560	Apparatus and method for sizing a distal femur	August, 2005	Dietzel et al.
20050192589	Devices and methods for inserting a spinal fixation element	September, 2005	Raymond et al.
20050203532	Technique and instrumentation for intervertebral prosthesis implantation using independent landmarks	September, 2005	Ferguson et al.
20050234552	Facet arthroplasty devices and methods	October, 2005	Reiley
20050235508	Facet joint prosthesis measurement and implant tools	October, 2005	Augostino et al.
20050240264	Anti-rotation fixation element for spinal prostheses	October, 2005	Tokish, Jr. et al.
20050240265	Crossbar spinal prosthesis having a modular design and related implantation methods	October, 2005	Kuiper et al.
20050240266	Crossbar spinal prosthesis having a modular design and related implantation methods	October, 2005	Kuiper et al.
20050251256	Facet arthroplasty devices and methods	November, 2005	Reiley
20050261770	Crossbar spinal prosthesis having a modular design and related implantation methods	November, 2005	Kuiper et al.
20050267579	Implantable device for facet joint replacement	December, 2005	Reiley et al.
20050283238	Facet arthroplasty devices and methods	December, 2005	Reiley
20060009847	Facet arthroplasty devices and methods	January, 2006	Reiley
20060009848	Facet arthroplasty device and methods	January, 2006	Reiley
20060009849	Facet arthroplasty devices and methods	January, 2006	Reiley
20060029186	Spinal midline indicator	February, 2006	De Villiers et al.	378/163
20060041311	Devices and methods for treating facet joints	February, 2006	McLeer
20060052785	Adjacent level facet arthroplasty devices, spine stabilization systems, and methods	March, 2006	Augostino et al.
20060058791	Implantable spinal device revision system	March, 2006	Broman et al.
20060064106	Coplanar X-ray guided aiming arm for locking of intramedullary nails	March, 2006	Fernandez	606/98
20060079895	Methods and devices for improved bonding of devices to bone	April, 2006	McLeer
20060084986	Instrument and method for the insertion and alignment of an intervertebral implant	April, 2006	Grinberg et al.	606/61
20060085068	Spine microsurgery techniques, training aids and implants	April, 2006	Barry	623/17.11
20060085075	Polymeric joint complex and methods of use	April, 2006	McLeer
20060100707	PROSTHESES, TOOLS AND METHODS FOR REPLACEMENT OF NATURAL FACET JOINTS WITH ARTIFICIAL FACET JOINT SURFACES	May, 2006	Stinson et al.
20060100709	FACET ARTHROPLASTY DEVICES AND METHODS	May, 2006	Reiley et al.
20060106398	CERVICAL BONE PREPARATION TOOL AND IMPLANT GUIDE SYSTEMS	May, 2006	Lauryssen et al.	606/96
20060149375	Prostheses, Tools And Methods For Replacement Of Natural Facet Joints With Artificial Facet Joint Surfaces	July, 2006	Yuan et al.
20060184180	Facet Joint Prosthesis Measurement and Implant Tools	August, 2006	Augostino et al.
20060265070	PROSTHESES AND METHODS FOR REPLACEMENT OF NATURAL FACET JOINTS WITH ARTIFICIAL FACET JOINT SURFACES	November, 2006	Stinson et al.
20070079517	Facet joint prosthesis measurement and implant tools	April, 2007	Augostino et al.
20070088358	Minimally Invasive Spine Restoration Systems, Devices, Methods and Kits	April, 2007	Yuan et al.
20070239159	Systems and methods for stabilization of bone structures	October, 2007	Altarac et al.	606/61
20070276370	Minimally invasive tooling for delivery of interspinous spacer	November, 2007	Altarac et al.	606/61
20070282344	Bone drill and methods of use	December, 2007	Yedlicka et al.	606/80
20080039866	LOCATING GUIDE	February, 2008	Stetz et al.	606/129

DE10135771	July, 2001
EP1103226	May, 2001			Transverse connector
EP1205152	May, 2002			Spinal column deformity correction device
EP1254639	November, 2002			DORSOLUMBAR AND LUMBOSACRAL VERTEBRAE FIXING SYSTEM
FR2726459	May, 1996
FR2749155	December, 1997
FR2844180	March, 2004
IES970323	June, 1998
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JP10082605	March, 1998			JIG FOR MEASURING ANGLE OF PIPE CONNECTION PART
JP10179622	July, 1998			VERTEBRAL IMPLANT
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WO/1999/060957	December, 1999			METHODS AND APPARATUS FOR SEPARATING AND STABILIZING ADJACENT VERTEBRAE
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WO/2001/028442	April, 2001			INTERVERTEBRAL IMPLANT
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WO/2001/067972	September, 2001			SPINAL IMPLANT CONNECTION ASSEMBLY
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WO/2002/000270	January, 2002			BIO-COMPATIBLE POLYMERIC MATERIALS
WO/2002/000275	January, 2002			BIO-COMPATIBLE POLYMERIC MATERIALS
WO/2002/002024	January, 2002			POLYAXIAL VERTEBRAL FIXING SYSTEM
WO/2002/002158	January, 2002			BIO-COMPATIBLE POLYMERIC MATERIALS
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WO/2002/034150	May, 2002			SPINAL IMPLANT CONNECTION ASSEMBLY
WO/2002/043603	June, 2002			INTERVERTEBRAL STABILISING DEVICE
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WO/2002/089712	November, 2002			INTERVERTEBRAL IMPLANT FOR TRANSFORAMINAL POSTERIOR LUMBAR INTERBODY FUSION PROCEDURE
WO/2003/020143	March, 2003			BILATERAL LAMINOPLASTY IMPLANTS
WO/2003/041618	May, 2003			POSTERIOR VERTEBRAL JOINT PROSTHESIS
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WO/2003/101350	December, 2003			PROSTHESES, SYSTEMS AND METHODS FOR REPLACEMENT OF NATURAL FACET JOINTS WITH ARTIFICIAL FACET JOINT SURFACES
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WO/2004/103227	December, 2004			PROSTHESES AND TOOLS FOR REPLACEMENT OF NATURAL FACET JOINTS WITH ARTIFICIAL FACET JOINT SURFACES
WO/2004/103228	December, 2004			PROSTHESES AND TOOLS FOR REPLACEMENT OF NATURAL FACET JOINTS WITH ARTIFICIAL FACET JOINT SURFACES
WO/2005/009301	February, 2005			PROSTHESES AND TOOLS FOR REPLACEMENT OF NATURAL FACET JOINTS

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Smith R. A.

Shay Glenn LLP

CROSS-REFERENCE

This application is a continuation-in-part of commonly assigned U.S. patent application Ser. No. 10/831,651 to Augostino et al. filed Apr. 22, 2004, now U.S. Pat. No. 7,051,451 and entitled “Facet joint Measurement and Implant Tools,” which is incorperated herein by reference.

This application is also a continuation-in-part of commonly assigned U.S. patent application Ser. No. 11/071,541 to Kuiper et al., filed Mar. 2, 2005, and entitled “Crossbar Spinal Prosthesis Having a Modular Design and Related Implantation Methods,” which is incorporated herein by reference which in turn claims the benefit of U.S. Provisional Patent Application Ser. No. 60/642,321 to Funk et al, filed Jan. 7, 2005, and entitled “Component Selection Instrument”, which is also incorporated herein by reference.

What is claimed is:

1. A component selection tool adapted and configured for use in a spinal column comprising: a stem adapted to be inserted into a pedicle of a vertebral body, the stem comprising a first marker having a first two dimensional geometric profile; and a head extending from the stem, the head comprising a plurality of second markers, the plurality of second markers each having a second two-dimensional geometric profile different from the first two-dimensional profile.

2. The component selection tool of claim 1 wherein the stem and the head are integrally formed.

3. The component selection tool of claim 1 wherein the stem is adapted and configured to engage the head.

4. The component selection tool of claim 1 wherein at least one of the stem and the head are formed from radiolucent material.

5. The component selection tool of claim 1 wherein the first marker is a radiopaque ball.

6. The component selection tool of claim 1 wherein the second radiopaque markers are each a cylindrical rod or tube with a shaped exterior surface.

7. The component selection tool of claim 1 wherein at least one of the second radiopaque markers has an exterior shape selected from smooth, turned and notched.

8. The component selection tool of claim 1 wherein the plurality of second radiopaque markers each have an exterior shape that is one of smooth, turned or notched.

9. The component selection tool of claim 1 wherein the plurality of second radiopaque markers have at least one first exterior shape that is smooth, turned or notched, and a second exterior shape different from the first exterior shape.

10. The component selection tool of claim 1 wherein the plurality of second radiopaque markers lie in a single plane within the head.

11. The component selection tool of claim 1 wherein the plurality of second radiopaque markers are positioned parallel in a plane.

12. The component selection tool of claim 1 wherein the head further comprises a plurality of third radiopaque markers.

13. The component selection tool of claim 12 wherein the third radiopaque markers are positioned perpendicular in a plane to the second radiopaque markers.

14. The component selection tool of claim 12 wherein the plurality of third radiopaque markers have an exterior shape selected from smooth, turned and notched.

15. The component selection tool of claim 12 wherein the plurality of third radiopaque markers each have an exterior shape that is one of smooth, turned or notched.

16. The component selection tool of claim 12 wherein the plurality of third radiopaque markers have at least one first exterior shape that is smooth, turned or notched, and a second exterior shape different from the first exterior shape.

17. The component selection tool of claim 12 wherein the plurality of third radiopaque markers lie in a single plane within the component selection tool.

18. The component selection tool of claim 12 wherein the plurality of third radiopaque markers are positioned non-parallel in a plane.

19. The component selection tool of claim 1 wherein the stem has a cylindrical shape with a first diameter at a distal end and a second diameter at a proximal end.

20. The component selection tool of claim 1 wherein the stem is telescoping.

21. The component selection tool of claim 1 wherein the stem has a diameter of 6.5 mm or less.

22. The component selection tool of claim 1 wherein the stem has a diameter between 4.5 mm and 6.5 mm.

23. The component selection tool of claim 1 wherein the stem defines a longitudinal axis, the first marker being disposed along the longitudinal axis, at least one of the second markers being spaced away from the longitudinal axis.

24. The component selection tool of claim 1 wherein the head has a dimension at least twice a diameter of the stem.

25. The component selection tool of claim 24 wherein the head dimension is parallel to the stem diameter.

FIELD OF THE INVENTION

This invention relates to implantable spinal devices, systems, and methods for treating various types of spinal pathologies. The invention relates in particular to the sizing and attachment of implantable devices to spinal vertebrae using component selection tools and methods.

BACKGROUND OF THE INVENTION

Back pain, particularly in the small of the back, or lumbosacral region (L4-S1) of the spine, is a common ailment. In many cases, the pain severely limits a person's functional ability and quality of life. Back pain interferes with work, routine daily activities, and recreation. It is estimated that Americans spend $50 billion each year on low back pain alone. It is the most common cause of job-related disability and a leading contributor to missed work.

Through disease or injury, the laminae, spinous process, articular processes, facets and/or facet capsule(s) of one or more vertebral bodies along with one or more intervertebral discs can become damaged which can result in a loss of proper alignment or loss of proper articulation of the vertebra. This damage can result in anatomical changes, loss of mobility, and pain or discomfort. For example, the vertebral facet joints can be damaged by traumatic injury or as a result of disease. Diseases damaging the spine and/or facets include osteoarthritis where the cartilage of joint is gradually worn away and the adjacent bone is remodeled, ankylosing spondylolysis (or rheumatoid arthritis) of the spine which can lead to spinal rigidity, and degenerative spondylolisthesis which results in a forward displacement of the lumbar vertebra on the sacrum. Damage to facet joints of the vertebral body often can also results in pressure on nerves, commonly referred to as “pinched” nerves, or nerve compression or impingement. The result is pain, misaligned anatomy, and a corresponding loss of mobility. Pressure on nerves can also occur without facet joint pathology, e.g., a herniated disc.

One conventional treatment of facet joint pathology is spine stabilization, also known as intervertebral stabilization. Intervertebral stabilization desirably controls, prevents or limits relative motion between the vertebrae, through the use of spinal hardware, removal of some or all of the intervertebral disc, fixation of the facet joints, bone graft/osteo-inductive/osteo-conductive material (with or without concurrent insertion of fusion cages) positioned between the vertebral bodies, and/or some combination thereof, resulting in the fixation of (or limiting the motion of) any number of adjacent vertebrae to stabilize and prevent/limit/control relative movement between those treated vertebrae. Stabilization of vertebral bodies can range from the insertion of motion limiting devices (such as intervertebral spacers, artificial ligaments and/or dynamic stabilization devices), through devices promoting arthrodesis (rod and screw systems, cable fixation systems, fusion cages, etc.), up to and including complete removal of some or all of a vertebral body from the spinal column (which may be due to extensive bone damage and/or tumorous growth inside the bone) and insertion of a vertebral body replacement (generally anchored into the adjacent upper and lower vertebral bodies). Various devices are known for fixing the spine and/or sacral bone adjacent the vertebra, as well as attaching devices used for fixation, including: U.S. Pat. Nos. 6,811,567, 6,619,091, 6,290,703, 5,782,833, 5,738,585, 6,547,790, 6,638,321, 6,520,963, 6,074,391, 5,569,247, 5,891,145, 6,090,111, 6,451,021, 5,683,392, 5,863,293, 5,964,760, 6,010,503, 6,019,759, 6,540,749, 6,077,262, 6,248,105, 6,524,315, 5,797,911, 5,879,350, 5,885,285, 5,643,263, 6,565,565, 5,725,527, 6,471,705, 6,554,843, 5,575,792, 5,688,274, 5,690,630, 6,022,350, 4,805,602, 5,474,555, 4,611,581, 5,129,900, 5,741,255, 6,132,430; and U.S. Patent Publication No. 2002/0120272.

SUMMARY OF THE INVENTION

What is needed are methods and tools for facilitating the sizing, orientation and implant of implantable spinal devices such as artificial facet joints. Moreover, there is a need in the art for methods and devices which facilitate the less-invasive, minimally-invasive and/or non-invasive measurement of the anatomical characteristics (including size, shape, orientation and/or relationship) of anatomical features of bones such as the vertebrae. The present invention provides tools and methods designed to aid in the placement of implantable facet joints at virtually all spinal levels including, but not limited to, L1-L2, L2-L3, L3-L4, L4-L5, L5-S1, T11-T12, and T12-L1.

Because the specific features of a patient's spinal anatomy can vary significantly from patient to patient (and can also vary within the various spinal levels of an individual patient or even vary between the facet joints in a single vertebral level), an implantable spinal device suitable for implantation into a patient will desirably be configured or tailored to be patient specific in order to accommodate the specific features of that patient's spinal anatomy. For example, the size, spacing and orientation of the pedicles, lamina and associated spinal anatomy, as well as the size, spacing and orientation of the individual facet joints to be replaced, can vary widely depending upon the level and/or patient to be treated.

In order to accommodate such variations in anatomy, a configurable and/or modular implantable device system (comprising multiple configurable and/or interchangeable components of varying shapes and/or sizes) may be used to tailor the implantable device to the varying anatomical demands of a given patient. Once the surgical site has been prepared, the implantable device can be assembled and/or configured from components chosen by the physician based on anatomical measurements of the treatment site during the surgery. The disclosed invention desirably facilitates such measurements of the treated anatomy.

In one aspect, the present invention provides a measurement tool for configuring and installing a cephalad facet joint implantable device including a fixation measurement element and a support arm element. This measurement tool assists in the selection of a cephalad facet joint implantable device for implantation in a patient. The measurement tool can be used in the determination of the dimensions of a cephalad facet joint implantable device. Particularly, this measurement tool can be used to determine the length of the fixation element and support arm element of the cephalad facet joint implantable device.

In some embodiments, the connection between the fixation measurement element and support arm element is a polyaxially adjustable connection. In one embodiment, the fixation measurement element has indentations which control the vertical movement of the support arm element. The indentations on the fixation measurement element can also permit the determination of the length of the fixation element of a cephalad facet joint implantable device.

In one embodiment, the support arm element supports a trial facet joint bearing surface. The bearing surface is intended to predict the location of the facet joint bearing surface of an actual implantable device intended for implantation in a patient.

The fixation measurement element in one embodiment is adapted and configured to permit measurements for determination of the length of the fixation element of a cephalad facet joint implantable device for implantation in a patient. In another embodiment, the fixation measurement element includes markings to assist in the determination of the length of the fixation element of a cephalad facet joint implantable device.

In another aspect, the present invention provides a caudad facet joint implantable device measurement system including a stem element and a trial caudad bearing surface element connected to each other by a fastener or fastening mechanism. This measurement tool assists in the selection of a caudad facet joint implantable device for implantation in a patient. The measurement tool can be used in the determination of the dimensions of a caudad facet joint implantable device. Particularly, this measurement tool can be used to determine the length of the fixation element of the caudad facet joint implantable device to be implanted in a patient. Also, this tool can be used to determine the angle between the artificial facet joint element and fixation element of the caudad facet joint implantable device. If desired, the mechanism can permit motion between the elements for alignment purposes and also allow locking of the chosen configuration/orientation once determined.

In one embodiment, the fastener used in the caudad facet joint implantable device measurement tool is a screw. Examples of other suitable fasteners could include stems, posts, threads, polyaxial mechanisms, splines, tapers, press fits, bayonet, cap screws, ball detents, friction fits, cams, collets and/or clamps. In certain embodiments, the fastener permits vertical movement of the trial caudad bearing surface element along the stem element. In other embodiments, the fastener permits rotation of the trial caudad bearing surface element in different planes with respect to the stem element. These planes can include movement along the axial and median planes.

In another embodiment, the stem element is adapted and configured to permit measurement of the length of a fixation element of a caudad facet joint implantable device to be implanted in a patient. In yet another embodiment, the stem element of the measurement tool includes markings to permit the measurement of the length of the fixation element.

In one of the embodiments, the measurement tool for the caudad facet joint implantable device is adapted and configured to permit measurement of the angle between the artificial facet joint element and fixation element of a caudad facet joint implantable device to be implanted in a patient. The angle measurements can include measurements in the median, horizontal and frontal planes (such measurements could also include measurements relative to the coronal, sagittal and/or axial planes, if desired). In one embodiment, to facilitate the determination of the angle measurement, the trial caudad bearing surface element is adapted and configured to interact with a measurement tool holder.

In one aspect, the invention is a measurement tool holder including a measurement surface connected to a holder element. This tool holder assists in determining the angle measurements obtained with the caudad facet joint. implantable device measurement tool. The caudad facet joint implantable device measurement tool can be placed in the tool holder and the angle between the artificial facet joint element and fixation element of a caudad facet joint implantable device can be determined.

In one embodiment, the measurement tool holder is adapted and configured to hold the measurement tool for the caudad facet joint implantable device. In yet another embodiment, the measurement surface of the tool holder includes two plates at right angles to each other. The plates can include markings to permit determination of the angle measurements, preferably in the horizontal and median planes.

Another aspect of the invention provides a method for determining the dimensions of a cephalad facet joint implantable device to be implanted in a patient. The method includes the steps of forming a hole at a location in the vertebra and placing a fixation measurement element of a cephalad facet joint implantable device measurement tool into the hole. Further optional steps include the steps of obtaining a first length measurement to determine length of a fixation element of a cephalad facet joint implantable device to be implanted in a patient; and obtaining a second length measurement for determining the length of a support arm element of the cephalad facet joint implantable device. In various embodiment, the measurement tool can be used in conjunction with a caudad implantable device or other implanted device, or can be used in conjunction with the caudad joint surface or other natural anatomical landmark.

Yet another aspect of the invention provides a method for determining the dimensions of a caudad facet joint implantable device to be implanted in a patient. The method includes the steps of forming a hole at a location in the vertebra and placing a caudad facet joint implantable device measurement tool into the hole. Further optional steps include the steps of obtaining a length measurement which indicates the length of a fixation element of a caudad facet joint implantable device to be implanted in a patient; and obtaining an angle measurement which indicates the angle between an artificial facet joint element and a fixation element of the caudad facet joint implantable device. In an alternate embodiment, the external surfaces of the measurement tool could incorporate calibrated markings allowing angle measurements to be determined without an associated measurement fixture.

In yet another aspect of the invention a component selection instrument is provided that facilitates the less-invasive, minimally-invasive and/or non-invasive measurement of the anatomical characteristics of the drill channel created in the pedicle in anticipation of implantation of a facet joint implantable device. In the various embodiments, the components of the component selection instrument can be visualized using non-invasive visualization (such as fluoroscopy, etc.) to determine the various appropriate components of a modular facet replacement system without requiring actual trialing of the components prior to permanent implantation.

The invention also includes a component selection tool adapted and configured for use in a spinal column comprising: a stem; a head; and a first marker having a first two dimensional geometric profile at a first location within the component selection tool and a second marker having a second two-dimensional geometric profile at a second location within the component selection tool. In some embodiments, the stem and head of the component selection tool are integrally formed. In other embodiments, the stem and head are component parts and the stem is adapted and configured to engage the head. In yet other embodiments, at least one of the stem and the head are formed from radiolucent material. The first marker can be configured as a radiopaque ball. In contrast, the second radiopaque marker can be configured as a cylindrical rod or tube with a shaped exterior surface. Suitable exterior shapes for the rod include smooth, turned, notched, and etched. Moreover, in other embodiments, a plurality of second radiopaque markers can be provided to provide additional reference markings. In embodiments where a plurality of second radiopaque markers are used, each of the markers can have the same or different shapes which are selected from smooth, turned and notched. In at least some embodiments, the plurality of second radiopaque markers can be configured to lie within a single plane within the component selection tool and can further be configured to be parallel one another within the plane. In at least some embodiments, the second radiopaque marker(s) are located within the head of the component selection tool. Other embodiments of the invention can be configured to provide a third radiopaque marker. The third radiopaque marker can be positioned in a plane that is perpendicular to the plane in which the second radiopaque markers lie. As with the second radiopaque markers, more than one third radiopaque marker can be provided, each or any of which can have an exterior shape that is smooth, turned or notched. Additionally, the third radiopaque marker(s) can be positioned within the head of the component selection tool. Where second and third radiopaque markers are used, the second markers can be configured with a first exterior shape and the third markers can be configured with a second exterior shape to assist in assessing the position of the component selection instrument relative to the anatomy. The third radiopaque markers can also lie parallel one another within the plane or be positioned non-parallel. The stem of the component selection tool can be configured to be telescoping, and can be configured to have a first diameter at a distal end and a second diameter at a proximal end. The first radiopaque marker can be positioned within the stem either integrally or located within a hollow shaft of the stem

The invention also includes a pair of component selection tools adapted and configured for use in a right and left side of a vertebral body of a spinal column or a first and second vertebral body, each component selection tool comprising: a stem; a head; and a first marker having a first two dimensional geometric profile at a first location within the component selection tool and a second marker having a second two-dimensional geometric profile at a second location within the component selection tool wherein the second marker in a first component selection tool has a first shape and the second marker in a second component selection tool has a second shape different than the first shape of the first component selector tool markers. In some embodiments the shape of the first and second, second radiopaque markers can have the same or different shapes which are selected from smooth, turned, notched and etched. In some embodiments, the stem and head of the component selection tool are integrally formed. In other embodiments, the stem and head are component parts and the stem is adapted and configured to engage the head. In yet other embodiments, at least one of the stem and the head are formed from radiolucent material. In at least some embodiments, the plurality of second radiopaque markers of either of the first or second component selection tool can be configured to lie within a single plane within the component selection tool and can further be configured to be parallel one another within the plane. In at least some embodiments, the second radiopaque marker(s) of either of the first or second component selection tools are located within the head of the component selection tool. Other embodiments of the invention can be configured to provide a third radiopaque marker. The third radiopaque marker for each of the component selection instruments can be positioned in a plane that is perpendicular to the plane in which the second radiopaque markers lie. As with the second radiopaque markers, more than one third radiopaque marker can be provided, each or any of which can have an exterior shape that is smooth, turned or notched. Additionally, the third radiopaque marker(s) can be positioned within the head of the component selection tool. The third radiopaque markers can also lie parallel one another within the plane or be positioned non-parallel. The stem of the component selection tool can be configured to be telescoping, and can be configured to have a first diameter at a distal end and a second diameter at a proximal end. The first radiopaque marker can be positioned within the stem either integrally or located within a hollow shaft of the stem.

Embodiments of the invention also include methods of using a component selection tool comprising: accessing a target anatomy; creating a pilot hole within a portion of the target anatomy; inserting a stem of a component selection tool within the pilot hole; taking a first image of the target anatomy having the component selection tool; analyzing the image of the target anatomy with the component selection tool to determine position of a first marker and a second marker; and selecting a component for implantation into the target anatomy. Templates can be used in combination with the image to analyze the image of the target anatomy with the component selection tool. Further, the pilot hole can be revised to achieve a larger diameter. Thereafter the component selection tool can be placed within the revised pilot hole before taking a second image of the component selection tool in the revised pilot hole.

Embodiments of the invention also include the use of kits, such as a kit comprising a first component selection instrument having a first marker and at least one second marker and a second component selection instrument having a first marker and at least one second marker, wherein the geometric profile of the second marker in the first component selection instrument is not the same as the geometric profile of the second marker in the second component selection instrument.

Embodiments of the invention also include methods, such as a method of using a component selection tool comprising: accessing a target anatomy; creating a pilot hole within a portion of the target anatomy; inserting a stem of a component selection tool within the pilot hole; taking a first image of the target anatomy having the component selection tool; analyzing the image of the target anatomy with the component selection tool to determine position of a first marker and a second marker; and selecting a component for implantation into the target anatomy.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:

FIG. 1 is a lateral view of a normal human spinal column;

FIG. 2 is a superior view of a normal human lumbar vertebra;

FIG. 3 is a lateral view of a functional spinal unit;

FIG. 4 is a postero-lateral oblique view of a vertebrae;

FIG. 5 is a perspective view of the anatomical planes of the human body;

FIG. 6 is a perspective view of a cephalad facet joint implantable device suitable for replacing the inferior half of a natural facet joint on a superior vertebral body;

FIG. 7A-B are views of one embodiment of a measurement tool for installing a cephalad facet joint;

FIGS. 8A, 8B and 8C are views of one embodiment of an installed measurement tool for an artificial cephalad facet joint;

FIG. 9 is a perspective view of one embodiment of a caudad implantable device for replacing the superior half of a natural facet joint on an inferior vertebral body;

FIGS. 10A and 10B are views of one embodiment of a measurement tool for implanting an artificial caudad facet joint;

FIGS. 11A-D are views of one embodiment of a measurement tool holder for holding a measurement tool for a caudad cephalad facet joint;

FIGS. 12A and 12B are views of one embodiment of an installed measurement tool for a caudad cephalad facet joint;

FIGS. 13A-B are views of another embodiment of a measurement tool for a caudad facet joint;

FIGS. 14A-C are views of a measurement tool for a caudad facet joint;

FIGS. 15A-D are views of a measurement tool illustrating the interior component of a measurement tool for a caudad facet joint;

FIGS. 16 is an exploded view of an alternative embodiment of a measurement tool according to the invention;

FIGS. 17A-C are views of a tool for implanting the measurement tool of the invention;

FIGS. 18A-D illustrate a measurement tool of the invention along with guides used with the measuring tool to assess the size and angle of the device to be implanted;

FIGS. 19A illustrates an image taken of a section of spine with the measurement tool incorporated therein to provide radiopaque markers; FIGS. 19B illustrates a spine having two measurement tools associated therewith;

FIGS. 20A illustrates a radiological image of a caudad selection tool in combination with a sizing template;

FIGS. 20B illustrates a portion of the spine with the measurement tools extending therefrom;

FIGS. 21 illustrates a superior view of a vertebral body with a measurement tool associated therewith and a radiological image of the measurement tool within the spine;

FIGS. 22 illustrates a side view of vertebral body with two measurement tools associated therewith and a radiological image of the tool within the spine; and

FIG. 23 is a flow chart illustrating method steps for determining the size of an artificial facet joint using the tools of the invention.

DETAILED DESCRIPTION OF THE INVENTION

The invention relates to tools for use with implantable devices, including implantable prosthesis suitable for implantation within the body to restore and/or augment connective tissue such as bone, and systems and methods for treating spinal pathologies that incorporate use of the tools. The invention relates generally to implantable devices and tools for use with implantable devices and apparatuses or mechanisms that are suitable for implantation within a human body to restore, augment, and/or replace soft tissue and connective tissue, including bone and cartilage, and systems for treating spinal pathologies. In various embodiments, the implantable devices used with the tools can include devices designed to replace missing, removed or resected body parts or structure. The implantable devices, tools, apparatus or mechanisms are configured such that the devices or tools can be formed from parts, elements or components which alone, or in combination, comprise the device or tools. Thus, for example the tools can be configured to work with implantable devices formed from parts, elements or components. The implantable devices can also be configured such that one or more elements or components are formed integrally to achieve a desired physiological, operational or functional result such that the components complete the device. Similarly, tools can be configured such that one or more elements or components are formed integrally to achieve a desired physiological, operational or functional result such that the components complete the tool. Functional results can include the surgical restoration and functional power of a joint, controlling, limiting or altering the functional power of a joint, and/or eliminating the functional power of a joint by preventing joint motion. Portions of the device can be configured to replace or augment existing anatomy and/or implanted devices, and/or be used in combination with resection or removal of existing anatomical structure.

The tools of the invention are designed to interact with the human spinal column 10, as shown in FIG. 1, which is comprised of a series of thirty-three stacked vertebrae 12 divided into five regions. The cervical region includes seven vertebrae, known as C1-C7. The thoracic region includes twelve vertebrae, known as T1-T12. The lumbar region contains five vertebrae, known as L1-L5. The sacral region is comprised of five fused vertebrae, known as S1-S5, while the coccygeal region contains four fused vertebrae, known as Co1-Co4.

An example of one vertebra is illustrated in FIG. 2 which depicts a superior plan view of a normal human lumbar vertebra 12. Although human lumbar vertebrae vary somewhat according to location, the vertebrae share many common features. Each vertebra 12 includes a vertebral body 14. Two short boney protrusions, the pedicles 16, 16′, extend dorsally from each side of the vertebral body 14 to form a vertebral arch 18 which defines the vertebral foramen.

At the posterior end of each pedicle 16, the vertebral arch 18 flares out into broad plates of bone known as the laminae 20. The laminae 20 fuse with each other to form a spinous process 22. The spinous process 22 provides for muscle and ligamentous attachment. A smooth transition from the pedicles 16 to the laminae 20 is interrupted by the formation of a series of processes.

Two transverse processes 24, 24′ thrust out laterally, one on each side, from the junction of the pedicle 16 with the lamina 20. The transverse processes 24, 24′ serve as levers for the attachment of muscles to the vertebrae 12. Four articular processes, two superior 26, 26′ and two inferior 28, 28′, also rise from the junctions of the pedicles 16 and the laminae 20. The superior articular processes 26, 26′ are sharp oval plates of bone rising upward on each side of the vertebrae, while the inferior processes 28, 28′ are oval plates of bone that jut downward on each side. See also FIG. 4.

The superior and inferior articular processes 26 and 28 each have a natural bony structure known as a facet. The superior articular facet 30 faces medially upward, while the inferior articular facet 31 (see FIG. 3) faces laterally downward. When adjacent vertebrae 12 are aligned, the facets 30 and 31, capped with a smooth articular cartilage and encapsulated by ligaments, interlock to form a facet joint 32. The facet joints are apophyseal joints that have a loose capsule and a synovial lining.

As discussed, the facet joint 32 is composed of a superior facet 30 and an inferior facet 31 (shown in FIG. 4). The superior facet is formed by the vertebral level below the joint 32, and the inferior facet is formed in the vertebral level above the joint 32. For example, in the L4-L5 facet joint shown in FIG. 3, the superior facet of the joint 32 is formed by bony structure on the L5 vertebra (i.e., a superior articular surface and supporting bone 26 on the L5 vertebra), and the inferior facet of the joint 32 is formed by bony structure on the L4 vertebra (i.e., an inferior articular surface and supporting bone 28 on the L4 vertebra). The angle formed by a facet joint located between a superior facet and an inferior facet changes with respect to the midline of the spine depending upon the location of the vertebral body along the spine. The facet joints do not, in and of themselves, substantially support axial loads unless the spine is in an extension posture (lordosis). As would be appreciated by those of skill in the art, the orientation of the facet joint for a particular pair of vertebral bodies changes significantly from the thoracic to the lumbar spine to accommodate a joint's ability to resist flexion-extension, lateral bending, and rotation.

An intervertebral disc 34 between each adjacent vertebra 12 (with stacked vertebral bodies shown as 14, 15 in FIG. 3) permits gliding movement between the vertebrae 12. The structure and alignment of the vertebrae 12 thus permit a range of movement of the vertebrae 12 relative to each other. FIG. 4 illustrates a posterolateral oblique view of a vertebrae 12, further illustrating the curved surface of the superior articular facet 30 and the protruding structure of the inferior facet 31 adapted to mate with the opposing superior articular facet. As discussed above, the position of the inferior facet 31 and superior facet 30 varies on a particular vertebral body to achieve the desired biomechanical behavior of a region of the spine.

Thus, the overall spine comprises a series of functional spinal units that are a motion segment consisting of two adjacent vertebral bodies, the intervertebral disc, associated ligaments, and facet joints. See, Posner, I, et al. A biomechanical analysis of the clinical stability of the lumbar and lumbrosacral spine. Spine 7:374-389 (1982).

As previously described, a natural facet joint, such as facet joint 32 (FIG. 3), has a superior facet 30 and an inferior facet 31. In anatomical terms, the superior facet of the joint is formed by the vertebral level below the joint, which can thus be called the “caudad” portion of the facet joint because it is anatomically closer to the tail bone or feet of the person. The inferior facet of the facet joint is formed by the vertebral level above the joint, which can be called the “cephalad” portion of the facet joint because it is anatomically closer to the head of the person. Thus, a device that, in use, replaces the caudad portion of a natural facet joint (i.e., the superior facet 30) can be referred to as a “caudad” device. Likewise, a device that, in use, replaces the cephalad portion of a natural facet joint (i.e., the inferior facet 31) can be referred to a “cephalad” device.

When the processes on one side of a vertebral body 14 are spaced differently from processes on the other side of the same vertebral body, components of the devices on each side would desirably be of differing sizes as well to account for anatomical difference that can occur between patients. Moreover, it can be difficult for a surgeon to determine the precise size and/or shape necessary for an implantable device until the surgical site has actually been prepared for receiving the device. In such case, the surgeon typically can quickly deploy a family of devices possessing differing sizes and/or shapes during the surgery. Thus, embodiments of the spinal devices of the present invention include modular designs that are either or both configurable and adaptable. Additionally, the various embodiments disclosed herein may also be formed into a kit or system of modular tools that can be assembled in situ to create a patient specific tool. As will be appreciated by those of skill in the art, as imaging technology improves, and mechanisms for interpreting the images (e.g., software tools) improve, patient specific designs employing these concepts may be configured or manufactured prior to the surgery. Thus, it is within the scope of the invention to provide for patient specific devices with integrally formed components that are pre-configured. Further, the practice of the present invention employs, unless otherwise indicated, conventional methods of x-ray imaging and processing, x-ray tomosynthesis, ultrasound including A-scan, B-scan and C-scan, computed tomography (CT scan), magnetic resonance imaging (MRI), optical coherence tomography, single photon emission tomography (SPECT) and positron emission tomography (PET) within the skill of the art. Such techniques are explained fully in the literature and need not be described herein. See, e.g., Essentials of Radiologic Science, Fosbinder and Kelsey, 2002, The McGraw-Hill Companies, publisher; X-Ray Structure Determination: A Practical Guide, 2nd Edition, editors Stout and Jensen, 1989, John Wiley & Sons, publisher; Body CT: A Practical Approach, editor Slone, 1999, McGraw-Hill publisher; X-ray Diagnosis: A Physician's Approach, editor Lam, 1998 Springer-Verlag, publisher.

A configurable modular device design, such as the one enabled by this invention, allows for individual components to be selected from a range of different sizes and utilized within a modular device. One example of size is to provide caudad and cephalad stems of various lengths. A modular implantable device design allows for individual components to be selected for different functional characteristics as well. One example of function is to provide stems having different surface features and/or textures to provide anti-rotation capability. Other examples of the configurability of modular implantable device of the present invention as described in greater detail below.

Implantable devices can be configurable such that the resulting implantable spinal device is selected and positioned to conform to a specific anatomy or desired surgical outcome. The adaptable aspect of devices provide the surgeon with customization options during the implantation or revision procedure. It is the adaptability of the device systems that also provides adjustment of the components during the implantation procedure to ensure optimal conformity to the desired anatomical orientation or surgical outcome. An adaptable modular device allows for the adjustment of various component-to-component relationships. One example of a component-to-component relationship is the rotational angular relationship between a crossbar mount and a crossbar in an implantable device. Configurability may be thought of as the selection of a particular size of component that together with other component size selections results in a custom fit implantable device. Adaptability then can refer to the implantation and adjustment of the individual components within a range of positions in such a way as to fine tune the “custom fit” devices for an individual patient. The net result is that embodiments of the modular, configurable, adaptable spinal device and systems of the present invention allow the surgeon to alter the size, orientation, and relationship between the various components of the device to fit the particular needs of a patient during the actual surgical procedure. Tools that are configurable and adaptable in a manner similar to the devices are contemplated by the invention to achieve optimal device selection for a patent.

In order to understand the configurability, adaptability, and operational aspects of the invention, it is helpful to understand the anatomical references of the body 50 with respect to which the position and operation of the devices, and components thereof, are described. There are three anatomical planes generally used in anatomy to describe the human body and structure within the human body: the axial plane 52, the sagittal plane 54 and the coronal plane 56 (see FIG. 5). Additionally, devices, tools, and the operation of devices and tools are better understood with respect to the caudad 60 direction and/or the cephalad direction 62. Devices positioned within the body can be positioned dorsally 70 (or posteriorly) such that the placement or operation of the tools or device is toward the back or rear of the body. Alternatively, devices can be positioned ventrally 72 (or anteriorly) such that the placement or operation of the tool or device is toward the front of the body. Various embodiments of the spinal devices, tools and systems of the present invention may be configurable and variable with respect to a single anatomical plane or with respect to two or more anatomical planes. For example, a component or tool may be described as lying within and/or having adaptability or operability in relation to a single plane. For example, a stem may be positioned in a desired location relative to an axial plane and may be moveable between a number of adaptable positions or within a range of positions. Similarly, the various components can incorporate differing sizes and/or shapes in order to accommodate differing patient sizes and/or anticipated loads.

For purposes of illustrating the invention, an example of a cephalad facet joint that is suitable for use with the measurement tools and methods described herein is depicted in FIG. 6. See also, US 2005/0131406 A1 (Reiley, et al.) FIG. 6 shows an artificial cephalad facet joint 40 configured to replace the inferior articulating process of a facet joint 31, such as after the surgical removal of the articulating process. When the cephalad facet joint 40 is attached to a vertebra, the artificial facet joint element 44 articulates with the superior half of the facet joint 32. In this example, artificial facet joint 40 includes an artificial facet joint element 44 connected to a fixation element 52 via a polyaxial connection 41 that permits facet joint element 44 and fixation element 52 to be rotated with respect to each other around more than one axis. A fixing nut 48 is threadably engaged with the outer periphery of base 42 above the artificial facet joint element 44. Similarly, a set screw 46 is threadably engaged with the inner periphery of base 42 above the artificial facet joint element 44. The artificial facet joint element 44 includes a support arm 72 and a facet joint bearing surface 74. In alternative embodiments, other convex or concave shapes may be used for the facet joint bearing surface 74. Bearing surface 74 may be formed from biocompatible metals (such as cobalt chromium steel, surgical steels, titanium, titanium alloys, tantalum alloys, aluminum, etc.), ceramics, polyethylene, biocompatible polymers, and other materials known in the orthopedic arts. Fixation element 52 may be a screw, stem, corkscrew, wire, staple, adhesive, bone, and other materials known in the orthopedic arts.

As shown in FIGS. 7A and 7B, a measurement tool 400 suitable for use in installing and configuring the artificial facet joint 40 of FIG. 6 includes a support arm element 401 and a fixation measurement element 402 via a polyaxial connection element 403. The polyaxial connection element 403 permits movement of the support arm element 401 along the fixation measurement element 402 in multiple axes. The connection 403 permits vertical movement of the support arm element 401 along the fixation measurement element 402 (or fixation element) and also permits horizontal movement of the support arm element 401 relative to the fixation measurement element 402. In this manner, the measurement tool contains aspects of the actual artificial facet joint 40. Measurement tools optimized to aid in the implantation of other implantable spinal devices may have other features containing aspects of those devices.

The fixation measurement element 402 is adapted and configured to permit measurement of the length of a fixation element of an artificial cephalad facet joint to be installed in a patient. Preferably, markings 407 are present on the fixation measurement element 402 which permit the determination of this length measurement. Typically, a hole or cavity is formed in the vertebra of the patient at a location wherein the artificial cephalad facet joint 40 is intended to be installed and the measurement tool 400 is placed in this hole. The tool 400 is adjusted to a position similar to that of the artificial cephalad facet joint, and then the penetration depth of the fixation measurement element 402 into the hole is determined. This penetration depth assists the user in choosing the length of the fixation element required to attach the artificial cephalad facet joint to the vertebra.

In one embodiment, the fixation measurement element 402 includes indentations 411 such as those depicted in FIG. 7A. The indentations 409 provide stops for the vertical movement of the support arm 401 along the fixation measurement element 402, e.g., by engaging a ridge 411 in a support arm 401. The indentations 409 can also permit the determination of the length of the fixation element 52 of an artificial cephalad facet joint 40 to be installed in a patient. The indentations 409 may be formed at intervals corresponding to various fixation stems or screw lengths contained in a modular component kit.

Similarly, another length measurement can be obtained using the support arm element 401. Once the measurement tool 400 is placed into the hole or cavity drilled in the vertebra, the support arm 401 is positioned into a location wherein the artificial facet joint element 44 of the artificial cephalad facet joint 40 would be located. The distance between the fixation measurement element 402 and the putative location of facet joint bearing surface 74 of the artificial cephalad facet joint 40 is measured along the support arm element 401. This measurement is used to select the length of the support arm 72 of the cephalad facet joint 40 to be implanted in a patient. Alternatively, the measurement could correspond to a color coding or number/letter designation that is used to determine the appropriate correspondingly-identified artificial facet joint.

In one embodiment, a trial facet joint bearing surface 404 can be attached to the support arm element 401. The trial facet joint bearing surface 404 may be placed in the location that the actual artificial cephalad facet joint 40 would be placed and then the length measurement can be obtained which can be used to select the length of the support arm 72 of the artificial cephalad facet joint 40. Once again, the relationship between the measurement tool's fixation measurement element, support arm element and trial fa