`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`Attorney Docket No.: 108136.00029
`
`
`
`In re Patent of: Curran et al.
`
`U.S. Patent No.: 8,361,156
`Issue Date:
`January 29, 2013
`Appl. Ser. No.: 13/441,092
`Filing Date: April 6, 2012
`Title:
`SYSTEMS AND METHODS FOR SPINAL FUSION
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`DECLARATION OF LOIC JOSSE
`
`
`
`

`

`
`
`1. My name is Loic Josse. I am currently a Product Development
`
`Director in Europe at Swiss Manufacturing Operation Medtronic Europe Sàrl
`
`(“Medtronic”), specifically for Medtronic Spinal & Biologics. I began working at
`
`Sofamor (which became Sofamor Danek and was later acquired by Medtronic) in
`
`1994 as a Design Engineer for Interbody Devices. I was promoted through several
`
`levels of Design and Development Engineer in the Interbody Device group from
`
`1994 to 2008. I worked as an Interbody Device Development Engineer for
`
`Sofamor Danek in Paris in 2000, where my responsibilities included the design and
`
`development of interbody devices and related instruments.
`
`2.
`
`I have personal knowledge that Boomerang implants of over 40 mm
`
`in length were designed and made as of July 2000. Attached hereto as Appendix A
`
`is a redacted version of engineering drawings that I created in January 2000 that
`
`depict a boomerang implant having a length from end to end of 40.705 mm. At
`
`least some implants based on the dimensions in these engineering drawings were
`
`created for Dr. George Frey pursuant to a prescription he wrote requesting “large”
`
`Boomerang implants for his spine surgery practice. A true and correct copy of a
`
`redacted email string, on which I was copied, between Dr. Frey and Ming Liu, an
`
`engineer at Medtronic, evidencing the creation of these large Boomerang implants
`
`having a length greater than 40 mm for Dr. Frey is attached hereto as Appendix B.
`
`
`
`
`
`

`

`
`
`The prescription we received from Dr. Frey along with the associated redacted
`
`manufacturing document and drawings is attached hereto as Appendix C.
`
`3.
`
`I understand that a redacted version of engineering drawings showing
`
`this implant is attached to the Petitioner’s Reply in this proceeding as Exhibit MSD
`
`1014. As the creator of these engineering drawings, I know that Exhibit MSD
`
`1014 is a true and correct, albeit redacted, copy.
`
`4.
`
`In addition to this custom order of the Boomerang created for Dr.
`
`Frey, I know that Medtronic has commercialized interbody spinal fusion implants
`
`having a length of at least 40 mm, and implanted using a lateral approach. For
`
`example, Medtronic has sold another implant I was involved in designing called
`
`the Butterfly Anterior Lateral Fixation System (“Butterfly System”) since at least
`
`June 2001. The Butterfly System included, among other options, an interbody
`
`implant having a 40 mm length. A true and correct copy of a Butterfly System
`
`Surgical Technique from June 2001 is attached hereto as Appendix D. The
`
`Butterfly System includes commercial embodiments of the invention described and
`
`claimed in U.S. Patent No. 6,156,037 (the “‘037 Patent”), of which I am a listed
`
`inventor. The ‘037 Patent issued on December 5, 2000. A true and correct copy of
`
`the ‘037 Patent is attached hereto as Appendix E.
`
`5.
`
`Prior to the commercialization of the Butterfly System in 2001, I was
`
`a member of a research team that analyzed the stabilization achieved by the
`
`
`
`3
`
`

`

`Butterfly System. This required the implantation of the cage of the Butterfly
`
`System using a lateral approach. Our findings were reported in an article entitled
`
`“Lumbar lateral interbody cage with plate augmentation: in vitro biomechanical
`
`analysis,” published in European Spine Journal. A true and correct copy of this
`
`article is attached hereto as Appendix F.
`
`6.
`
`Although I am an employee of the Petitioner, no part of my
`
`compensation is dependent on the outcome of this proceeding, and l have no other
`
`interest in this proceeding.
`
`7.
`
`I hereby declare that all statements made herein of my own
`
`knowledge are true and that all statements made on information and belief are
`
`believed to be true; and further that these statements were made with the
`
`knowledge that willful false statements and the like so made are punishable by fine
`
`or imprisonment, or both, under Section 1001 of the Title 18 of the United States
`
`Code.
`
`Dated: 3/ [ls—Uéz /20 MI
`
`

`

`
`
`Appendices to the Josse Declaration
`
`APPENDIX A: Redacted version of engineering drawings showing Boomerang
`implant with a length greater than 40 mm
`
`
`APPENDIX B: Redacted email, dated July 4, 2000
`
`APPENDIX C: Prescription from Dr. Frey dated 8/14/00 and associated redacted
`manufacturing document and engineering drawings
`
`
`APPENDIX D: Butterfly Anterior Lateral Fixation System Surgical Technique
`Guide
`
`
`APPENDIX E: U.S. Patent No. 6,156,037
`
`APPENDIX F: J. C. Le Huec, M. Liu, W. Skalli, L. Josse (2002) Lumbar lateral
`interbody cage with plate augmentation: in vitro biomechanical
`analysis. Eur Spine J 11:130-136
`
`
`
`
`
`
`
`

`

`
`
`
`
`APPENDIX A
`APPENDIX A
`
`
`
`
`

`

`==n--:In
`
`
`
`
`
`
`
`SECTION c—c
`
`
`
`SECTION
`
`5-3
`
`

`

`APPENDIX B
`APPENDIX B
`
`
`
`
`
`
`
`
`
`
`

`

`Fax Bais par : ll14'13BIIml1
`
`SOFAHOH DANEK HOISS~
`
`~­•M•
`
`Ming Llu
`From:
`Sent:
`To:
`Cc:
`SubJect:
`
`Ming LIU
`Tuesday, July 04, 2000 12:30 PM
`'GFrey2SUNG)EIOI.com'
`
` Lore Josse
`
`RE: Boomerang
`
`Dear George,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`'
`
`...
`
`# of oaliti"made
`I
`2
`2
`···········-- -i ·······-
`2
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`
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`
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`
`lmnlant
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`~6
`Laroe 14
`• La;:::e 1~.
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`
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`.. ·····~--
`33
`33
`41
`41
`41
`
`-
`
`. """""""
`..
`
`.
`
`The Implants we made are of the following siZes:
`mm\ -
`D
`14
`14
`14
`18
`16
`18
`
`H (mm)
`1lL5
`10.5
`8.5
`14.5
`12.5
`10.5
`
`---------·--
`
`
`
`
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`
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`
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`
`
`07/04/00 23:13
`
`TX/RX N0.3592
`
`P.OOl
`
`•
`
`CONFIDENTIAL
`
`MNUV5061022
`
`

`

`Fax ftmis pa~
`
`8149388ft81
`
`SOFAMOJI DANEK JIOISSY
`
`P,.: YB
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
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`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
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`
`
`
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`
`
`
`
`
`
`
`
`
`
`
`
`
`07/04/00 23:13
`
`TX/RX N0.3592
`
`P.002
`
`•
`
`CONFIDENTIAL
`
`MNUV5061023
`
`

`

`APPENDIX C
`APPENDIX C
`
`
`
`
`
`

`

`Medtronic
`
`SOFAMOR DANEK
`
`6/14/00
`9/25/00
`
`Received
`Completed
`System
`Destination
`Shelf
`Loan Out
`Top Surgeon
`Payment
`Hospital # / P.O # / Order
`Method
`
`INTERBODY SPECIAL
`PROJ ECT
`Project No SPOO - 131
`Customer Dr. Frey
`Contact Loic Josse
`Vendor MTG
`Owner
`Jim Duncan
`Dr. Frey "Boomerang" Cages
`
`irb Tr t' (cid:9)
`lli -iri
`rr,
`-
`
`Medium 8 Implant
`Medium 10 Implant (cid:9)
`, __ _ —
`Medium 12 Implant 7----- (cid:9)
`• (cid:9)
`'N. (cid:9)
`%.--
`Large 10 Implant (cid:9)
`Large 12 Implant/ (cid:9)
`Large 14 Implant
`
`r'
`
`7 (cid:9)
`
`
`
`[1Qty Price
`2
`
`Cost
`
`2]
`2
`2
`1 2
`
`Part Number Part Description (cid:9)
`
`Project
`Descri • tion:
`
`CIB0700-001 (cid:9)
`'CIB0700-002 (cid:9)
`C1B0700-003 (cid:9)
`CIB0700-004 (cid:9)
`CIB0700-005
`CIB0700-011
`
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`
`(cid:9)
`

`

`
`
`

`

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`

`

`APPENDIX D
`APPENDIX D
`
`
`
`
`
`
`
`
`
`

`

`BUTTERFLY
`Fusion System
`
`Surgical Technique
`
`DRAFT COPY
`for internal use only
`
`

`

`The BUTTERFLY system has been
`designed to answer the growing need for
`an anterior lateral plate and offers
`advanced product features:
`
`-
`
`-
`
`Provides significant supplementary fixation to
`an interbody construct
`
`Low profile lumbar anterior lateral plate for
`L4-5 and higher levels
`
`- Anatomical fit between the concavity of the
`vertebral wall and the BUTTERFLY plate
`
`- Mini-open of endoscopic approach
`
`- Option of using a threaded cage which can be
`attached to the BUTTERFLY plate
`
`- Option of using the BUTTERFLY plate in
`conjunction with a anterior lateral impacted
`cage.
`
`Standard Plates
`Length: 48mm and 49.5mm
`
`Standard Cages
`Diameter: 14mm or 16mm
`Length: 30mm, 35mm, or 40mm
`
`Screw or Bolt Option
`Diameter: 6.5mm
`Length: 30mm, 35mm,
`40mm and 45mm.
`
`Case 1
`
`Pre-op
`
`Pre-op
`
`Used in conjunction
`with a Union-L
`Cage
`
`Post-op
`
`Pre-op
`51 year old female,
`painful discopathy
`with intermittent
`radicular pain, bulging
`disc on MRI.
`
`Post-op
`Post-op L4-5 anterior lateral
`arthrodesis with UNION interbody
`cage and BUTTERFLY plate Complete
`restoration of the foramen height.
`
`

`

`Maximum Compression Load
`
`100000
`1000000
`Number of Cycles
`
`10000000
`
`600
`500
`400
`300
`200
`100
`0
`10000
`
` Load (N)
`
`Maximum Compressive
`
`Range of Motion
`
`2.2
`2
`1.8
`1.6
`1.4
`1.2
`1
`.8
`.6
`.4
`.2
`0
`
`Intact
`Spine
`
`+ Cage
`
`+ Cage
`+ Plate
`
`+ Cage
`+ Plate
`+ Nut
`
`Mechanical Test
`
`The Butterfly Plate went under the static
`fatigue compression tests under ASTM
`F1717 corpectomy model. It showed that
`the Butterfly Plate presents a high level of
`mechanical strength.
`
`Biomechanical Test
`
`The Butterfly Plate went through
`biomechanical tests on human cadaver
`models. It showed that the Butterfly Plate
`provided significant supplementary
`stabilization to the spine.
`
`Case 2
`
`Pre-op
`
`Pre-op
`
`Post-op
`
`Pre-op
`Male, L4-5 foraminal
`stenosis with painful
`discopathy and loss of
`disc height.
`
`Post-op
`L4-5 anterior lateral approach for
`interbody arthrodesis using BUTTERFLY
`cage and plate.
`
`Attached with a Butterfly Cage
`
`

`

`Table of Contents
`
`Indications
`Contraindications
`
`ButterflyTM Plate & Cage
`Patient Positioning and Surgical Exposure
`Discectomy
`Partial Discectomy
`Guide Sleeve Distractor assembly
`Disc Distraction and Guide Sleeve Seating
`Endplate Reaming
`Cage packing and implantation
`Plate installation
`Insertion of screws
`
`Butterfly Plate & Union-LTM
`Bolt insertion
`Plate insertion with Union™ Cage
`Postoperative care
`Set composition Union-L™
`Set composition Interfix-lateral
`Set composition Butterfly
`
`Page 5
`Page 5
`
`Page 6
`Page 6
`Page 7
`Page 8
`Page 9
`Page 10
`Page 11
`Page 12
`Page 13
`
`Page 14
`Page 15
`Page 16
`Page 17
`Page 18
`Page 19
`
`4
`
`

`

`Butterfly Plate & Cage
`
`5
`
`INDICATIONS
`
`Generally indicated for lumbar and lumbosacral
`pathologies indicated for segmental arthrodesis including:
`• Degenerative discopathy:
`- Primary surgery for advanced discopathies or
`extensive destabilizing decompressions
`- Revision surgery for failed disc surgery,
`(recurrent disc herniation, post-operative instability)
`• Lumbar pseudarthrosis
`• Certain lumbar stenosis
`
`CONTRAINDICATIONS
`
`This device is not intended for cervical spine use.
`Contraindications include, but are not limited to:
`
`Infection, local to the operative site
`Signs of local inflammation
`Fever or leukocytosis
`Morbid obesity
`Pregnancy
`Mental illness
`Rapid joint disease, bone absorption, osteopenia,
`osteoporosis
`Suspected or documented allergy or intolerance to
`composite materials
`Patients with a known hereditary or acquired bone
`friability or calcification problem should not be considered
`for this type of surgery
`These devices should not be used for pediatric cases, nor
`where the patient still has skeletal growth
`Spondylolisthesis unable to be reduced to Grade 1
`Any cases where the implant components selected for use
`would be too large or too small to achieve a successful
`result
`Any case that requires the mixing of metals from two
`different components or systems
`Any patient having inadequate tissue coverage over the
`operative site or inadequate bone stock or quality
`Any patient in which implant utilization would interfere
`with anatomical structures or expected physiological
`performance
`
`

`

`PATIENT POSITIONING AND SURGICAL EXPOSURE
`
`The following selection describes the procedure using the
`Lateral Approach.
`
`The patient is placed in a right decubitus lateral position
`on the operating table. An oblique skin incision is made
`above the center of the targeted disc space. Exposure to
`the lateral aspect of the spine is obtained by a
`retroperitoneal approach. Psoas muscle is retracted
`posteriorly and held in place with the help of a retractor.
`Confirm the fusion level by means of lateral fluoroscopic
`control.
`
`A mini-ALIF approach can be made with the help of the
`Medtronic Sofamor Danek ENDORING retractor system.
`
`DISCECTOMY
`
`Perform about a 2.5mm wide lateral block discectomy.
`Using a Disc Rongeur to remove the disc material.
`
`Endplate preparation is carried out using surgical chisels
`and curettes. Remove the cartilage from the endplates to
`obtain a large flat surface on subchondral bone and a
`bleeding area in the center of the endplate.
`
`6
`
`

`

`PARTIAL DISCECTOMY
`
`The Guide Wire is placed into the Trephine and then
`approached to the entrance point on the disc. Before
`trephining, slightly impact the Guide Wire into the disc in
`order to avoid any slippage. A pre-perforation of the disc is
`performed with the Trephine until the stop level is
`reached.
`A-P and lateral fluoroscopic checks are recommended to
`confirm the targeted lumbar level and to ensure the safe
`trajectory of the trephine.
`The opening on the disc is enlarged with the help of the
`Cobb and the Kerrison in the set.
`Discectomy is performed, but the annulus is preserved to
`increased mechanical stability by tensioning the remaining
`annular and ligamental structures of the disc. The
`instrumentation will simultaneously remove the required
`volume of the disc and prepare the adjacent vertebral
`endplates for the fusion implant.
`
`7
`
`

`

`GUIDE SLEEVE DISTRACTOR ASSEMBLY
`
`Attach the Distractor head to the Implant Inserter. The
`number marked on the Distractor head indicates the
`distraction height in mm.
`Choose the corresponding Guide Sleeve, the first number
`marked on the sleeve should match that of the Distractor
`Head. Assemble the Guide Sleeve with the Implant
`Inserter and the Switching Sleeve in the following manner:
`1. Hold the Implant Inserter and keep pushing the sliding
`bloc,
`2. Slide the Switching Sleeve on the Implant Inserter and
`turn it to find the indexed position,
`3. Slide the Guide Sleeve onto the Switching Sleeve and
`find the indexed position,
`4. Turn the slack collar on the Protection Sleeve for
`connecting.
`
`8
`
`

`

`DISC DISTRACTION AND GUIDE SLEEVE SEATING
`
`Introduce the assembly (long blade anterior) into the disc
`space through the prepared opening and impact it slightly
`with a mallet until it is firmly seated into the disc space. A
`lateral fluoroscopic control is recommended at this stage.
`
`Loosen completely the slack collar to disconnect the
`assembly. Turn the T-Handle 90° to open the disc space.
`The Distractor Head should be firmly held into the disc
`space, otherwise choose a larger Distractor Head and the
`corresponding Guide Sleeve, (go back to Step 2).
`
`Re-orientate the extension blades on the Guide Sleeve to
`the disc space. Be sure that the longer extension blade is
`placed to the anterior side of the spine and the curved end
`of the Guide Sleeve matched the border of the vertebral
`endplates. Place the Impactor on the Guide Sleeve. Impact
`it with a mallet until both extension blades are completely
`inserted into the disc space and the Guide Sleeve firmly
`seated against the vertebral bodies.
`
`NOTE: Prior to impacting, make sure that all surrounding
`delicate soft tissues are clearly identified and adequately
`retracted.
`
`9
`
`

`

`ENDPLATE REAMING
`
`Remove the Distractor and the Switching Sleeve from the
`Guide Sleeve. At this stage of the surgery, A-P and lateral
`fluoroscopic controls are recommended to confirm the
`proper disc distraction and the correct placement of the
`Guide Sleeve.
`
`The implant can be precisely determined in the following
`way:
`
`Distractor Size
`Implant Diameter
`
`8mm
`14 or 16mm
`
`10mmm
`16mm
`
`12mm
`18 or 20mm
`
`14mm
`20mm
`
`As the anterior extension blade is measured 30mm in
`length, the A-P fluoroscopic image can help to determine
`the implant length.
`
`The Reamer is used to complete the discectomy and
`endplate preparation. The number marked on the Reamer
`corresponds to the diameter of the cage to be used. Set the
`adjustable stop to the first line which corresponds to a
`35mm reaming depth. Place the Reamer into the Guide
`Sleeve and turn it clockwise until the stop level is reached.
`Several passes of reaming process need to be performed
`while cleaning the disc debris attached to the reamer after
`each pass.
`
`A deeper reaming depth can be adjusted every 3mm,
`based on fluoroscopic check, by loosening the collet and
`resetting.
`
`After each reaming process, any remaining loose disc
`material should be removed by using the IVD Rongeur
`through the protection Sleeve.
`
`10
`
`

`

`CAGE PACKING AND IMPLANTATION
`
`The Implant is placed on the Implant Support in an upright
`position and the cap is removed. The Graft Impactor is
`used to gently compact the morsalized fragments into the
`Implant to ensure the Implant is completely filled. The cap
`is place on the Implant.
`Attach the Butterfly Implant to the Implant Inserter. Place
`the Implant Inserter into the Guide Sleeve and begin
`screwing the Implant into the prepared disc space until the
`predetermined depth indication reaches the border of the
`Guide Sleeve. The cage should be positioned about
`2-3mm countersink to the lateral wall.
`
`Detach the Implant Inserter after the cage position is
`confirmed by A-P and lateral fluoroscopic check. Connect
`the Wrench to the Guide Sleeve. Remove the Protection
`Sleeve with the help of the Fork Hammer.
`
`NOTE: We recommend to use a cage of 5mm shorter than
`the measured depth in order to place cancellous bone in
`the disc space before cage insertion.
`
`11
`
`

`

`PLATE INSTALLATION
`
`Slide the Cage Adjuster into the Nut Driver. Attach the Nut
`to the Cage Adjuster. Take the Butterfly Plate with the Plate
`Holder, turning the outer sleeve down in order to firmly
`attach the Plate. Slide both the Cage Adjusters and the Nut
`Driver into the Plate Holder.
`
`Introduce the assembly into the operation field through the
`skin opening. Attach the cage Adjuster to the Cage. Slide
`down the Plate Holder and push the Plate firmly against
`the vertebral bodies. Adjust the cage position by screwing
`or unscrewing in order for the cage to be in contact with
`the Plate.
`
`Turn the Nut Driver to release the Nut and bring it to the
`threaded end of the cage. Tighten the Nut to fix the Plate
`onto the cage.
`
`Insert the Z-Plate screws in to the vertebral bodies through
`the holes of the Plate.
`
`12
`
`

`

`BELIIOIEYETELY
`
`INSERTION OF SCREWS
`
`INHION OF SCREWS
`
`13
`
`

`

`Option with the Union-L™ cage
`Insertion of the cage - refer to Union-L™ Surgical Technique
`
`BOLT INSERTION
`
`14
`
`

`

`Butterfly & Union-L Cage
`
`15
`
`PLATE INSERTION WITH UNION CAGE
`
`

`

`POST-OPERATIVE CARE
`
`Wound closure is carried out in a routine manner.
`Ambulation begins when tolerated, usually the following day.
`Keep patient calm for first 3 days.
`
`16
`
`

`

`SET COMPOSTION UNION-L™
`UNION™ & UNION-L™ INSTRUMENTS
`
`GENERAL INSTRUMENTS UNION
`175106
`Guide Tip 6
`175108
`Guide Tip 8
`175110
`Trial 10/26
`175112
`Trial 12/26
`1750114
`Trial 14/26
`1750116
`Trial 16/26
`175210
`Trial 10/31
`175212
`Trial 12/31
`1750214
`Trial 14/31
`1750216
`Trail 16/31
`175120
`Rail Cutter 10/26
`175122
`Rail Cutter 12/26
`1750124
`Rail Cutter 14/26
`1750126
`Rail Cutter 16/26
`175220
`Rail Cutter 10/31
`175222
`Rail Cutter 12/31
`1750224
`Rail Cutter 14/31
`1750226
`Rail Cutter 16/31
`175126
`Protection Tube 6/26
`175128
`Protection Tube 8/26
`175136
`Protection Tube 6/31
`175138
`Protection Tube 8/31
`175426
`Handle 26
`175431
`Handle 31
`175502
`Impactor Cap
`175503
`Fork Hammer
`175506
`Graft Impactor
`895-IDR00
`Disc Rongeur
`175109
`Connection Pin
`
`GENERAL INSTRUMENTS UNION-L
`1750300
`Lateral Distractor Tip
`1750310
`Lateral Trial M10
`1750312
`Lateral Trial M12
`1750314
`Lateral Trial M14
`1750316
`Lateral Trial M16
`1750130
`Lateral Rail Cutter M10
`1750132
`Lateral Rail Cutter M12
`1750134
`Lateral Rail Cutter M14
`1750136
`Lateral Rail Cutter M16
`1750230
`Lateral Guide 10
`1750232
`Lateral Guide 12
`1750234
`Lateral Guide 14
`1750236
`Lateral Guide 16
`
`17
`
`

`

`SET COMPOSTION INTERFIX-LATERAL
`
`INTERFIX-LATERAL INSTRUMENTS
`
`GENERAL INSTRUMENTS
`
`894.093 Guide Wire
`
`896.103 Wrench
`
`896.104 Fork Hammer
`
`896.105 Trephine 8
`
`896.106 Trephine 10
`
`950.940 IVD Rongeur
`
`950.931 Kerrinson 5mm
`
`896.101 Bone Graft Impactor
`
`950.902 Cobb
`
`896.102 Impactor
`
`14/16mm Instruments
`
`896.508 Distractor Head 8
`
`896.510 Distractor Head 10
`
`896.346 Implant Inserter 14/16
`
`896.414 Protection Sleeve 8/14,16
`
`896.416 Protection Sleeve 10/16
`
`896.646 Switching Sleeve 14/16
`
`896.746 Adapter Sleeve 14/16
`
`895-IBF00 Adjustable Reamer Stop
`
`896.214 Reamer 14
`
`896.216 Reamer 16
`
`18
`
`

`

`SET COMPOSTION BUTTERFLY
`
`BUTTERFLY IMPLANTS & INSTRUMENTS
`
`IMPLANTS
`8965001
`8966430
`8966435
`8966440
`8966630
`8966635
`8966640
`
`Plates
`8968848
`8968849
`
`Butterfly Nut
`Butterfly Cage 14/30
`Butterfly Cage 14/35
`Butterfly Cage 14/40
`Butterfly Cage 16/30
`Butterfly Cage 16/35
`Butterfly Cage 16/40
`
`Plate 48mm
`Plate 49.5mm
`
`Bolts
`Butterfly Bolt D6.5 L30
`8962630
`Butterfly Bolt D6.5 L35
`8962635
`Butterfly Bolt D6.5 L40
`8962640
`Butterfly Bolt D6.5 L45
`8962645
`843-160 Nut Bolt
`
`Bone Screw (Z-Plate Screws)
`822-230
`Bone Screw D6.5 L30
`822-235
`Bone Screw D6.5 L35
`822-240
`Bone Screw D6.5 L40
`822-245
`Bone Screw D6.5 L45
`
`INSTRUMENTS
`Butterfly Plate Holder
`8961010
`Butterfly Cage Holder
`8961030
`Butterfly Nut Holder
`8961020
`8961040
`Butterfly Cage Support
`8961050
`Butterfly Gauge
`8963048
`Butterfly Bolt Gauge 48
`8963049
`Butterfly Bolt Gauge 49.5
`Butterfly Bolt Holder 1
`8963010
`Butterfly Bolt Holder 2
`8963020
`8963060
`Butterfly Awl
`8963070 Butterfly Bolt Nut Holder
`8963080 Butterfly Screw Holder
`8963090 Butterfly Std Handle
`
`BOX
`8969100 Butterfly Container/Base Tray
`8969110 Butterfly Insert Tray
`8969200 Butterfly Lid
`
`19
`
`

`

`REF BO175-01 MEDTRONIC SOFAMOR DANEK 06/2001 - all rights reserved
`
`MEDTRONIC SOFAMOR DANEK EUROPEAN SPINE CENTER
`ZAC PARIS NORD II
`13 RUE DE LA PERDRIX
`BP 50302
`95940 ROISSY CDG CEDEX
`FRANCE
`Tel: +33 1 49 38 80 00 Fax: +33 1 49 38 80 01
`
`SOFAMOR SNC
`RCS Bobigny B617 320 486 - NAF 331B
`
`MEDTRONIC SOFAMOR DANEK U.K.
`The Bulse Grange
`Wendens Ambo, Saffron Walden
`CB11 4JT
`UNITED KINGDOM
`Tel: +44 17 99 54 25 67 Fax: +44 17 99 54 25 66
`
`MEDTRONIC SOFAMOR DANEK BELGIUM
`Herenthoutseweg 236
`B-2200 HERENTALS
`BELGIUM
`Tel: +32 14 32 14 70 Fax: +32 14 32 14 80
`
`MEDTRONIC ÖSTERRICHE GMBH
`Millenium Tower
`Handelskai 94 - 96
`1200 WIEN
`AUSTRIA
`Tel: +43 124 044 130 Fax: +43 124 044 330
`
`MEDTRONIC AG
`Bahnhofstr. 60
`CH-8600 DÜBENDORF
`SWITZERLAND
`Tel: +41 1 802 70 00 Fax: +41 1 802 70 10
`
`MEDTRONIC SOFAMOR DANEK PORTUGAL
`Rua Tomas da Fonseca
`Torre-E-8-A/B
`1600-209 LISBOA
`PORTUGAL
`Tel: +35 12 17 24 51 00 Fax: +35 12 17 24 51 99
`
`MEDTRONIC SOFAMOR DANEK FRANCE
`ZAC PARIS NORD II
`22 Avenue des Nations
`Bat le Rousseau
`BP 50406
`95944 ROISSY CDG CEDEX
`FRANCE
`Tel: +33 1 49 90 84 00 Fax: +33 1 49 90 84 99
`
`MEDTRONIC SOFAMOR DANEK GMBH
`265 Kölner Strasse
`51149 KÖLN
`GERMANY
`Tel: +49 22 03 91 19 20 Fax: +49 22 03 91 19 21
`
`MEDTRONIC SOFAMOR DANEK ITALIA SRL
`Via Archimede 31/33
`20041 AGRATE BRIANZA (MI)
`ITALY
`Tel: +39 039 651 643 Fax: +39 039 652 383
`
`MEDTRONIC SOFAMOR DANEK
`Burgemeester Stramanweg 101, 5th Floor
`1101 AA AMSTERDAM Z.O.
`THE NETHERLANDS
`Tel: +31 205 602 950 Fax: +31 206 962 694
`
`MEDTRONIC SOFAMOR DANEK
`SOUTH AFRICA
`1 East Gate Lane, Bedfordview
`JOHANNESBURG 2047
`REPUBLIC OF SOUTH AFRICA
`Tel: +27 11 616 2334 Fax: +27 11 622 1555
`
`MEDTRONIC SOFAMOR DANEK IBERICA, S.A.
`c/Calendula, 93
`Edificio « Medtronic G »
`El soto de la Moraleja - Alcobendas
`28109 ALCOBENDAS (MADRID)
`SPAIN
`Tel: +34 916 250 500 Fax: +34 916 250 580
`
`NOT FOR DISTRIBUTION IN THE UNITED STATES
`
`0123
`
`

`

`APPENDIX E
`APPENDIX E
`
`
`
`
`
`
`
`
`
`

`

`U5006156037A
`US006156037A
`United States Patent [19]
`United States Patent
`[19]
`6,156,037
`[11] Patent Number:
`6,156,037
`[11] Patent Number:
`
`Date of Patent:
`Dec. 5, 2000
`LeHuec et al.
`[45]
`[45] Date of Patent:
`Dec. 5, 2000
`LeHuec et al.
`
`[54] ANTERIOR LATERAL SPINE CAGE-PLATE
`[54] ANTERIOR LATERAL SPINE CAGE-PLATE
`FIXATION DEVICE AND TECHNIQUE
`FIXATION DEVICE AND TECHNIQUE
`
`[75] Inventors: Jean-Charles LeHuec, Bordeaux;
`[75]
`Inventors: Jean-Charles LeHuec, Bordeaux;
`-
`-
`-
`.
`'-‘
`Mmgyan Iflu’ Bourg'la'Reme’ L01c
`
`I Mmgyan Iflu’ Bourg 1a Rem’ Lolc I ' _ 'I'
`
`
`
`
`Josse, PalaJa, all of France
`J osse, PalaJa, all of France
`
`[73] Assignee: SDGI Holdings, Inc., Memphis, Tenn.
`[73] Assignee: SDGI Holdings, Inc., Memphis, Tenn.
`
`5,772,661
`6/1998 Michelson ................................. 606/61
`6/1998 Michelson
`606/61
`
`5,776,196
`7/1998 Matsuzaki et a1
`606/61
`7/1998 Matsuzaki et al. .
`.. 606/61
`5,776,197
`7/1998 Rabbe et al.
`606/61
`
`.. 606/61
`
`7/1998 Rabbe et al. 7/1998 Rabbe et al.
`
`37:23:33
`£133: 53%)? ‘1’: ‘1:
`im
`Egg/i;
`.. 606/61
`,
`,
`e
`10
`e a .
`..........................
`7/1998 Zd bl_ k t
`1
`623/17
`-
`5,904,683
`5/1999 Pohndorfet al.
`......................... 606/61
`
`e 10 e a. 5/1999 Pohndorfet al.
`606/61
`Primary Examiner—Gary Jackson
`Primary Examiner—Gary Jackson
`Assistant Examiner—Duphna Shai
`Assistant Examiner—Duphna Shai
`Attorney, Agent, or Firm—Woodard, Emhardt, Naughton
`Attorney, Agent, or Firm—Woodard, Emhardt, Naughton
`Moriarty & McNett
`Moriarty & McNett
`[57]
`[57]
`An interbody fusion cage has an externally threaded stem
`An interbody fusion cage has an externally threaded stem
`projecting from a domed outer end. A contoured plate is
`projecting from a domed outer end. A contoured plate is
`provided With an aperture receivable on the stem. The stem
`provided With an aperture receivable on the stem. The stem
`threads receive a nut to ?x the plate to the cage. Bone screWs
`threads receive a nut to fix the plate to the cage. Bone screws
`anchor the plate to vertebral bodies. A hemispherical surface
`anchor the plate to vertebral bodies. A hemispherical surface
`on the plate and surrounding the stem-receiving aperture and
`on the plate and surrounding the stem-receiving aperture and
`bearing on the dome, accommodates universal angulation of
`bearing on the dome, accommodates universal angulation of
`the plate relative to the cage. In addition to a cage installa-
`the plate relative to the cage. In addition to a cage installa
`tion tool, there is a plate installation tool assembly including
`tion tool, there is a plate installation tool assembly including
`a cage installer, a plate holder, a nut holder and cage adjuster,
`a cage installer, a plate holder, a nut holder and cage adjuster,
`a nut driver, and a plate holding prong controller.
`a nut driver, and a plate holding prong controller.
`
`ABSTRACT
`ABSTRACT
`
`36 Claims, 7 Drawing Sheets
`36 Claims, 7 Drawing Sheets
`
`[21] Appl. No.: 09/181,362
`[21] Appl. No: 09/181,362
`[22]
`Filed:
`Oct. 28, 1998
`[22]
`Filed:
`Oct. 28, 1998
`A61B 17/56
`51]
`[51]
`Int. Cl.7 ..................................................... A61B 17/56
`
`1 6 / 6 0 6
`[52] us. Cl.
`. 606/61; 606/69; 606/72
`..................
`
`[52] US. Cl. [58] Field of Search
`[58] Field of Search .................................. 606/61 69 72
`’ 606/73
`606/73
`
`09 66
`
`22,
`6,
`H7
`
`
`
`
` 66 00 66
`
`mm
`91
`
`
`[56]
`[56]
`
`References Cited
`References Cited
`US. PATENT DOCUMENTS
`U.S. PATENT DOCUMENTS
`3/1997 Michelson.
`D. 378,409
`3/1997 Michelson .
`D. 378,409
`
`.. 606/61
`6/1994 Zdeblick et al.
`.
`5,324,290
`6/1994 Zdeblick et al. .
`5,324,290
`.. 606/61
`.. 606/61
`5,569,247 10/1996 Morrison ..........
`
`.. 606/61
`..... 606/61
`5,676,666
`10/1997 Oxland et al.
`
`
`5,569,247 10/1996 Morrison 5,676,666 10/1997 OXland et al. 5,683,391 11/1997 Boyd
`.. 606/61
`5,683,391
`11/1997 Boyd ......................................... 606/61
`606/61
`
`
`
`

`

`US. Patent
`U.S. Patent
`
`Dec. 5,2000
`Dec. 5, 2000
`
`Sheet 1 0f 7
`Sheet 1 0f 7
`
`6,156,037
`6,156,037
`
`
`
`

`

`US. Patent
`U.S. Patent
`
`Dec. 5,2000
`Dec. 5, 2000
`
`Sheet 2 0f 7
`Sheet 2 0f 7
`
`6,156,037
`6,156,037
`
`
`
`Fig. 4
`
`Fig. 6
`Fig. 6
`
`

`

`U.S. Patent
`US. Patent
`
`Dec. 5,2000
`Dec. 5,2000
`
`Sheet 3 0f 7
`Sheet 3 0f 7
`
`6,156,037
`6,156,037
`
`12
`
`21
`
`33p
`
`33
`
`
`
`
`
`
`“(WWII/1
`
`
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`
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`
`
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`39
`
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`I
`___ _ _~1___‘________ ___
`
`
`
`
`
`

`

`U.S. Patent
`US. Patent
`
`Dec. 5,2000
`Dec. 5,2000
`
`Sheet 4 0f 7
`Sheet 4 0f 7
`
`6,156,037
`6,156,037
`
`
`
`

`

`US. Patent
`U.S. Patent
`
`Dec. 5,2000
`Dec. 5, 2000
`
`Sheet 5 0f 7
`Sheet 5 0f 7
`
`6,156,037
`6,156,037
`
`
`
`

`

`U.S. Patent
`US. Patent
`
`Dec. 5,2000
`Dec. 5,2000
`
`Sheet 6 0f 7
`Sheet 6 0f 7
`
`6,156,037
`6,156,037
`
`
`
`Fig."14
`
`Fig.15
`
`

`

`US. Patent
`
`6,156,037
`
`
`

`

`1
`1
`ANTERIOR LATERAL SPINE CAGE-PLATE
`ANTERIOR LATERAL SPINE CAGE-PLATE
`FIXATION DEVICE AND TECHNIQUE
`FIXATION DEVICE AND TECHNIQUE
`BACKGROUND OF THE INVENTION
`BACKGROUND OF THE INVENTION
`In the art of spinal surgery, various devices and methods
`In the art of spinal surgery, various devices and methods
`for interbody fusion have been developed and are described
`for interbody fusion have been developed and are described
`in literature. US. Pat. No. 5,772,661 issued Jun. 30, 1998 to
`in literature. US. Pat. No. 5,772,661 issued Jun. 30, 1998 to
`Michelson is an example. US. Pat. No. 5,683,391 issued
`Michelson is an example. US. Pat. No. 5,683,391 issued
`Nov. 4, 1997 to Lawrence M. Boyd describes a system for
`Nov. 4, 1997 to LaWrence M. Boyd describes a system for
`attachment of cylindrical
`interbody fusion devices to a
`attachment of cylindrical interbody fusion devices to a
`spinal rod to which bone screws are also attached and
`spinal rod to Which bone screWs are also attached and
`anchored in the vertebral bodies.
`It
`is desirable that