GLOBUS MEDICAL, INC.
`EXHIBIT 1004
`IPR2015-to be assigned
`(Globus v. Flexuspine)
`
`1 of 24
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`

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`US 7,828,849 B2
`Page 2
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`U.S. PATENT DOCUMENTS
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`5,782,830
`5,865,848
`5,888,224
`5,888,227
`5,893,889
`5,895,426
`5,980,522
`5,984,922
`6,045,579
`6,080,158
`6,080,193
`6,090,143
`6,102,950
`6,113,638
`6,117,174
`6,159,245
`6,176,881
`6,176,882
`6,183,517
`6,190,414
`6,217,579
`6,245,108
`6,319,257
`6,368,351
`6,371,989
`6,419,705
`6,419,706
`6,432,108
`6,436,140
`6,436,142
`6,443,989
`6,454,806
`6,454,807
`6,468,276
`6,517,051
`6,562,074
`6,576,016
`
`A
`A
`A
`A
`A
`A
`A
`A
`A
`A
`A
`A
`A
`A
`A
`A
`B1 *
`B1
`B1
`B1
`B1
`B1
`B1
`B1
`B1
`B1
`B1
`B1 *
`B1
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`B1 *
`B2
`B1
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`7/1998
`2/1999
`3/1999
`3/1999
`4/1999
`4/1999
`11/1999
`11/1999
`4/2000
`6/2000
`6/2000
`7/2000
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`9/2000
`12/2000
`1/2001
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`10/2002
`2/2003
`5/2003
`6/2003
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`. 623/17.11
`
`Farris
`Baker
`Bookers or air
`Coriio
`Harrington
`Scarborough or air
`Koros or air
`McKay
`Hocirsiririer
`Lin
`Hocirsiririer or air
`Moriwoiiror or air
`Vaooaro
`Williams or air
`Noian
`Meriweiiier or air
`
`Schar et al.
`Biederrnann or air
`Snddaby
`Young or air
`Koros
`Biscup
`Carignan or air
`Glenn et al.
`Chauvin et al.
`Erickson
`Gmf
`Burgess et al.
`Lin on n1_
`paes on 31,
`Jackson
`Conon on on
`Jackson
`MoKny
`Cavanaugh ................ .. 254/88
`Gerbec et al.
`Hochshuler et al.
`
`.............. .. 606/61
`
`6,641,614 B1
`6,676,703 B2
`6,706,070 B1
`6,767,366 B2
`6,830,589 B2
`6,852,129 B2
`6,893,464 B2
`2001/0032020 A1
`2002/0010511 A1
`2002/0045943 A1
`2002/0045945 A1
`2002/0068976 A1
`2002/0068977 A1
`2002/0128713 A1
`2002/0128716 A1
`2002/0138146 A1
`2002/0143401 A1
`2002/0177897 A1
`2003/0139312 A1
`2003/0149484 A1
`2004/0059421 A1
`2004/0087947 A1 *
`2004/0102847 A1
`2004/0127993 A1
`2004/0127994 A1
`
`11/2003
`1/2004
`3/2004
`7/2004
`12/2004
`2/2005
`5/2005
`10/2001
`1/2002
`4/2002
`4/2002
`6/2002
`6/2002
`9/2002
`9/2002
`9/2002
`10/2002
`11/2002
`7/2003
`8/2003
`3/2004
`5/2004
`5/2004
`7/2004
`7/2004
`
`Wagner et al.
`Biscup
`Wagner et al.
`Lee et al.
`Erickson
`Gerbec et al.
`Kiester
`Besselink
`Michelson
`Uk
`Liu et al.
`Jackson
`Jackson
`Ferree
`Biro et al.
`Jackson
`Michelson
`Michelson
`Garcia et al.
`Michelson
`Glenn et al.
`Lim et al.
`................... .. 606/61
`Sato et al.
`Kast et al.
`Kast et al.
`
`FOREIGN PATENT DOCUMENTS
`
`2824261
`FR
`W0 97/00054
`W0
`W0 98/48738
`W0
`W0 99/32054
`W0
`W0 99/42062
`W0
`W0 00/74605
`W0
`W0 02/38062
`W0
`W0 03/092507
`W0
`W0 W0 2004/019829
`
`* cited by examiner
`
`11/2002
`1/1997
`11/1998
`7/1999
`8/1999
`12/2000
`5/2002
`11/2003
`3/2004
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`U.S. Patent
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`Nov. 9, 2010
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`FIG. 26
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`\\\nI.Llrl
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`FIG. 27
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`FIG. 28
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`US 7,828,849 B2
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`1
`EXPANDING INTERBODY IMPLANT AND
`ARTICULATING INSERTER AND METHOD
`
`RELATED APPLICATIONS
`
`This application claims priority under 35 U.S.C. §119(e)
`from the following U.S. provisional application: Application
`Ser. No. 60/444,561 filed on Feb. 3, 2003. This application is
`expressly incorporated in its entirety by reference herein.
`
`BACKGROUND
`
`Various devices are used for controlling the spacing
`between vertebral members. These devices may be used on a
`temporary basis, such as during surgery when it is necessary
`to access the specific surfaces of the vertebral member. One
`example includes preparing the endplates of a vertebral mem-
`ber. The devices may also remain permanently within the
`patient to space the vertebral members.
`It is often difficult to position the device between the ver-
`tebral members in a minimally invasive manner. A device that
`is small may be inserted i11to the patient a11d between the
`vertebral members in a minimally invasive manner. However,
`the small size may not be adequate to effectively space the
`vertebral members. A larger device may be effective to space
`the vertebral members, but cannot be inserted into the patient
`and between the vertebral members iii a minimally invasive
`manner.
`
`SUMMARY
`
`The present invention is directed to a device for positioning
`between adjacent vertebral members. In one embodiment, the
`device generally includes a spacer, a delivery device, and a
`deployer. The spacer is positioned between adjacent vertebral
`members and is selectively adjustable between a closed ori-
`entation, open orientation, and gradations therebetween. The
`delivery device positions the spacer within the patient, and the
`deployer moves the spacer to the selected orientation.
`In one embodiment, the spacer is selectively positionable
`between a first orientation having a minimum height, a sec-
`ond orientation having a maximum height, and selectedposi-
`tioned therebetween. The device may include a first member
`having a first angled surface that extends in a first direction,
`and a second member having a second angled surface that
`extends in a second direction. As the first member is moved
`
`relative to the second member, the angled surfaces contact
`each other and the size of the spacer increases. The device
`may be positioned on a delivery device such that it can be
`removed from the patient when the procedure is completed,
`or may be detachable from the delivery device to remain
`within the patient, either permanently or for a predetermined
`period.
`In one embodiment of using the device, the device is posi-
`tioned between two vertebral members. During the position-
`ing, the device is in a closed orientation having a small size to
`facilitate insertion and be minimally invasive to the patient.
`The spacer may be angled relative to the delivery device to
`position the spacer between the vertebral members. Once
`positioned, the sections of the spacer are moved relative to
`each other such that the angled surfaces contact each other.
`The contact and movement ofthe members causes the overall
`
`height ofthe spacer to increase. The spacer may be positioned
`within a variety ofheights depending upon the application. In
`some embodiments, the spacer includes a locking means to
`lock the spacer at a height and prevent the spacer from clos-
`mg.
`
`10
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`15
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`20
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`25
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`30
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`40
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`2
`BRIEF DESCRIPTION OF TH DRAWINGS
`
`FIG. 1 is a perspective view of one embodiment of the
`present invention;
`FIG. 2 is a perspective view of the spacer in a closed
`orientation according to one embodiment of the present
`invention;
`FIG. 3 is a perspective view of the spacer in an open
`orientation according to one embodiment of the present
`invention;
`FIG. 4 is an exploded perspective view of the spacer
`according to one embodiment of the present invention;
`FIG. 5 is a perspective view of the first member according
`to one embodiment of the present invention;
`FIG. 6 is a perspective view of the third member in a first
`position within the second member according to one embodi-
`ment of the present invention;
`FIG. 7 is a perspective view ofthe third member in a second
`position within the second member according to one embodi-
`ment of the present invention;
`FIG. 8 is a partial cut-away perspective view ofthe locking
`mechanism according to one embodiment of the present
`invention;
`FIG. 9 is a perspective view of the first member in contact
`with the second member according to one embodiment ofthe
`present invention;
`FIG. 10 is a partial perspective view of the spacer angled
`relative to the delivery device according to one embodiment
`of the present invention;
`FIG. 11 is a partial perspective view of another embodi-
`ment of the spacer angled relative to the delivery device
`according to one embodiment of the present invention;
`FIG. 12 is a partial perspective view of the spacer disen-
`gaged from the delivery device according to one embodiment
`of the present invention;
`FIG. 13 is a partial perspective view of the holder and
`pivots in a first orientation according to one embodiment of
`the present invention;
`FIG. 14 is a partial perspective view of the holder and
`pivots in a second orientation according to one embodiment
`of the present invention;
`FIG. 15 is a partial perspective view of another embodi-
`ment of the spacer angled relative to the delivery device
`according to one embodiment of the present invention;
`FIG. 16 is a perspective view of the present invention
`according to one embodiment of the present invention;
`FIG. 17 is a partial perspective view of a section of the
`device according to one embodiment ofthe present invention;
`FIG. 18 is a partial perspective view illustrating the third
`member in a first position within the second member accord-
`ing to one embodiment of the present invention;
`FIG. 19 is a partial perspective view illustrating the third
`member in a second position within the second member
`according to one embodiment of the present invention;
`FIG. 20 is a partial perspective view of a lock according to
`one embodiment of the present invention;
`FIG. 21 is a partial perspective view of live pivots accord-
`ing to one embodiment of the present invention;
`FIG. 22 is a perspective view of another embodiment ofthe
`third member constructed according to one embodiment of
`the present invention;
`FIG. 23 is a partial perspective view of the cam in contact
`with the third member constructed according to one embodi-
`ment of the present invention;
`FIG. 24 is a partial perspective view of another delivery
`device and release mechanism constructed according to one
`embodiment of the present invention;
`
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`3
`FIG. 25 is a partial perspective View of the spacer attached
`to the delivery device constructed according to one embodi-
`ment of the present invention;
`FIG. 26 is a partial perspective view of the tube sleeve and
`cam constructed according to one embodiment of the present
`invention;
`FIG. 27 is a partial perspective view of the spacer attached
`to the delivery device constructed according to one embodi-
`ment of the present invention; and
`FIG. 28 is a partial perspective view of the spacer detached
`from the delivery device constructed according to one
`embodiment of the present invention.
`
`DETAILED DESCRIPTION
`
`The present invention is directed to a device for positioning
`between adjacent vertebral members. FIG. 1 illustrates one
`embodiment, generally indicated as 9, which includes a
`spacer 10, delivery device 80, and a deployer 7. Spacer 10 is
`positioned between adjacent vertebral members and is selec-
`tively adjustable between a closed orientation, open orienta-
`tion, a11d gradations tl1erebetwee11. Delivery device 80 fu11c-
`tions to position the spacer within the patient. Deployer 7
`moves the spacer to the selected expanded orientations.
`Spacer 10 has a variety of shapes and sizes depending upon
`the application, such as an elongated, curved shape. The
`spacer 10 is adjustable between a first position as illustrated in
`FIG. 2 having a reduced size to be minimally invasive when
`inserted into the patient between the vertebral members. FIG.
`3 illustrates a second position with the spacer 10 expanded to
`contact the vertebral members. The spacer 10 may be expand-
`able to a variety of different heights depending upon the
`desired application.
`FIGS. 2 and 3 illustrate one embodiment of the spacer 10
`having a rounded kidney shape with a first distal end 11 and
`second proximal end 12 each having a rounded shape. First
`and second sides 13, 14 are curved. The spacer 10 may have
`a substantially constant width, with one specific embodiment
`having a width of about 33 mm. The height of the spacer 10
`may vary depending upon the amount of deployment and is
`dictated by the angle of the ramped surfaces as will be
`described in detail below. In one specific embodiment, spacer
`10 has a height ranging from about 9 mm to about 13 mm. In
`one embodiment, the spacer 10 is angled in one or more ofthe
`closed, open, or deploying orientations to conform to the
`dimensions of the vertebral member.
`
`FIG. 4 illustrates one embodiment of the spacer 10 includ-
`ing a first member 20, a second member 30, and a third
`member 40. First member 20 includes contact surface 21 and
`second member 30 includes contact surface 31 each for con-
`
`tacting a vertebral member. Contact surfaces 21, 31 may be
`substantially smooth, or may have stabilization features such
`as ridges or knurls to contact the vertebral members.
`First and second members 20, 30 have complimentary
`shapes to mate together in the closed orientation. Outward
`edges 22, 32 of the members 20, 30 are adj acently positioned
`in the closed orientation to reduce the overall size of the
`
`spacer 10. Outward edge 32 may contact or be spaced apart
`from the inner edge of the contact surface 21 when the spacer
`10 is in the closed orientation. Sidewalls 23, 33 extend from
`the contact surfaces and may have a variety of different
`shapes and sizes to define the overall shape of the spacer 10.
`FIG. 5 illustrates one embodiment of the underside of the
`first member 20. Sidewalls 23 extend outward to mate with
`
`the second member 30. A tab 29 may extend outward from
`one of the sidewalls 23 to mate with a groove in the second
`member sidewall 33 to further stabilize during deployment
`
`4
`
`and when the spacer 10 is in the open orientations. Tabs 29
`contact an upper edge of the groove (see FIG. 18) to prevent
`the first member 20 from separating from the second member
`30 during deployment of the spacer 10.
`First member 20 includes a first angled section 25 and a
`support section 27, and a second angled section 26 and sup-
`port section 28. Angled sections 25, 26 may have a variety of
`lengths, and may be positioned at a variety of angles relative
`to the contact surface 21. The angled sections 26, 25 may be
`at the same angle, or may have different angles. In one
`embodiment, the range of angles between the sections 25, 26
`and contact surface 21 is between about 20° to about 40°.
`
`Support sections 27, 28 are positioned adjacent to the angled
`sections 25, 26 and are positioned at a different angle relative
`to the angled sections 25, 26. In one embodiment, support
`sections 27, 28 are substantially parallel with the contact
`surface 21.
`
`The shape of the second member 30 compliments the first
`member 20. Sidewalls 33 extend around a portion or the
`entirety of the second member 30 to align with the first mem-
`ber 20 and form an interior section to maintain the third
`member 40. An inner section 39 is formed within the side-
`
`10
`
`15
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`20
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`walls 33 opposite the contact surface 31. In one embodiment
`as illustrated in FIGS. 7 and 8, inner section 39 is substantially
`flat and smooth to facilitate the relative movement ofthe third
`
`25
`
`member 40. A frame 93 may extend from the second member
`30. Apertures 37 positioned on the frame 93 allow for attach-
`ment of the delivery device 80 as explained below.
`Third member 40 is positioned between the first member
`20 and second member 30. Third member 40 includes a first
`
`side 41 having angled sections 45, 46 that mate with the first
`member 20, and a second side 42 to contact the second mem-
`ber 30. One embodiment of the first side 41 is illustrated in
`
`FIG. 4 and includes a first angled section 45 and adjacent
`support section 47, and a second angled section 46 and sup-
`port section 48. Angled sections 45, 46 may have a variety of
`lengths, and may be positioned at a variety of angles relative
`to the second side 42. In one embodiment, the range of angles
`between sections 45, 46 and second side 41 is between about
`20° to about 40°. Support sections 47, 48 are positioned at a
`different angle relative to the angled sections 45, 46. In one
`embodiment, support sections 47, 48 are substantially paral-
`lel with the second side 42. In one embodiment, second side
`42 is flat which compliments a flat surface ofthe inner section
`39.
`
`Third member 40 may have a width and length less than or
`equal to the boundary formed by the sidewalls 33 of the
`second member 30. The smaller size provides for sliding
`movement of the third member 40 relative to the second
`
`member 30. The relative positioning of the second and third
`members 30, 40 is illustrated in FIGS. 6 and 7. FIG. 6 illus-
`trates a first position with the third member 40 positioned
`against a proximal edge of the second member 30.
`FIG. 7 illustrates a second position with the third member
`40 positioned against a distal edge of the second member 30.
`Third member 40 moves relative to the first and second
`
`members 20, 30 to deploy the spacer 10 from the closed
`orientation to the open orientation. The spacer 10 may be
`positioned within the patient in the closed orientation that has
`a minimal size and shape to facilitate placement within the
`patient and between the vertebral members. The angled sec-
`tions 25, 26, 45, 46 ofthe first and third members 20, 40 are
`disengaged in the closed orientation.
`Deployment ofthe spacer 10 is caused by the third member
`40 moving relative to the first member 20. Relative movement
`causes the angled sections 45, 46 of the third member 40 to
`contact the angled sections 25, 26 ofthe first member 20. This
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`causes the first member 20 to move outward away from the
`centerline of the spacer 10. As the third member 40 is moved
`further, the angled sections continue to slide relative to one
`another and the first member 20 continues to move outward
`
`from the centerline increasing the overall height of the spacer
`10.
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`5
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`15
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`FIG. 9 illustrates one embodiment at the open position with
`full deployment. The sections 27, 28 on the first member 20
`contact and rest on sections 47, 48 of the third member 40. In
`one embodiment, the sections 27, 28, 47, 48 are angled to a 10
`lesser amount than the angled sections 25, 26, 45, 46 to
`prevent the spacer 10 from moving towards the closed orien-
`tation. The angled sections 25, 26, 45, 46 may have the same
`angle.
`The rounded shape of the spacer 10 results in the some or
`all ofthe angled sections ofthe first and third members 20, 40
`having non-symmetrical shapes. In one embodiment illus-
`trated in FIG. 5, angled sections 25, 26 have a shorter length
`on the first edge 13 than on the second edge 14. Likewise, the
`angled sections 25, 26 are not aligned because of the rounded 20
`shape of the second member 20. FIG. 6 illustrates that angled
`surfaces 45, 46 having a first inner edge shorter than the
`second outer edge, and the angled surfaces not being aligned.
`The slope and sizes ofthe angled surfaces 25, 26, 45, 46 of
`the first and third members 20, 40 may vary to change the 25
`shape of the spacer 10 in the open orientation. The contact
`surfaces 21 and 31 may be oblique with the one end of the
`spacer 10 having a larger height than the other end, or may be
`substantially parallel in the open orientation and gradations of
`being open. The spacer 10 in the open orientation may be 30
`shaped to conform to the curvature of the spine.
`In one embodiment, the spacer 10 includes two members
`each having angled sections and there is no third member. The
`angled sections of the first member contact the angled sec-
`tions of the second member during the deployment. Each of 35
`the members may further include platform sections for con-
`tact in the open orientation.
`The spacer 10 may expand in both a first and second direc-
`tion. The third member 40 includes angled sections on the
`second side 42 that contact angled sections on the inner sec- 40
`tion 39 of the second member 30. In one embodiment, move-
`ment of the third member 40 results in both the first member
`
`20 and second member 30 moving outward from a centerline
`of the spacer 10.
`Another embodiment features one or more of the angled 45
`sections 25, 26, 45, 46 having a stepped configuration. The
`stepped configuration features an angled section having one
`or more steps positioned thereabout angled to a different
`degree. The steps are positioned along the angled sections 25,
`26, 45, 46 for deploying the spacer 10 to differing extents. A 50
`variety of step surfaces may be positioned on the sections. In
`one embodiment, angled sections 25, 26, 45, 46 each include
`two steps with the spacer positionable between a closed ori-
`entation, first orientation on a first step, second orientation on
`a second step, and fully deployed orientation.
`The first member 20 and the second member 30 may also
`each include a single angled section. Movement of the spacer
`10 results in only the single angled surfaces contacting. The
`angled surfaces may be positioned at any point along the
`length of the spacer 10. In one embodiment, support surfaces 60
`are positioned adjacent to the angled surfaces.
`A locking member 100 may lock the spacer 10 in a par-
`ticular position. In one embodiment as illustrated in FIG. 8,
`locking member 100 includes a pair of caps 102 forced apart
`by a biasing member 1 08 (FIG. 8 features the third member 40 65
`removed for clarity). Each cap 102 includes an extension 106
`sized to fit within the apertures positioned within the first
`
`55
`
`6
`member 20 or second member 30. In one embodiment, a pair
`of apertures 35 are positioned on the third member 30 for
`receiving the locking member 100. As the third member 40
`moves relative to the second member 20, the locking member
`100 extends into one or more of the apertures 35. In one
`embodiment, apertures are positioned for receiving the caps
`102 when the spacer 100 is at the open orientation and the
`support sections are in contact. In another embodiment, aper-
`tures 35 are positioned for receiving the caps 102 while the
`angled surfaces are in contact. The locking member 100 pre-
`vents the third member 40 from sliding outward and inadvert-
`ently reducing the spacer size. In a spacer 10 having a stepped
`configuration on the angled sections, aperture pairs may be
`positioned to lock the spacer at each gradation. In one
`embodiment, locking mechanism 100 includes a single cap
`102 that is fit into a single aperture. A spacer is disclosed in
`previously filed U.S. patent application Ser. No. 10/229,560
`entitled Minimally Invasive Expanding Spacer and Method,
`filed Aug. 28, 2002 and assigned to the same entity as the
`present application and is herein incorporated by reference in
`its entirety.
`The delivery device 80 functions to position the spacer 10
`within the patient. Delivery device 80 has an elongated shape
`for the physician to position the spacer 10 within the patient
`between vertebral members. In one embodiment as illustrated
`
`in FIG. 12, delivery device 80 has an elongated shape sized
`with a distal end attached to the spacer 10 and a proximal end
`positioned exterior to the patient. Delivery device 80 may
`have a variety of cross-sectional shapes and sizes depending
`upon the application. Delivery device 80 may be constructed
`of a single elongated member, or may be constructed of
`different sections.
`
`Delivery device 80 may be mounted to the spacer in a
`pivoting manner. FIG. 11 illustrates one embodiment of the
`delivery device 80 comprising a first shaft 81 and a second
`shaft 82. A holder 55 is positioned at the distal end ofthe shaft
`82. Holder 55 includes apertures 57 through which live pivots
`90 extend. In one embodiment, an angled edge 91 conforms
`with the spacer frame 93. A link 54 is pivotally mounted
`between holder 55 and the first shaft 81. The first shaft 81 is
`
`selectively positionable to pivot the holder 55 about the live
`pivots 90 and thus pivot the spacer 10 relative to the delivery
`device 80. A bracket 56 may be formed at the end of the first
`shaft 81 for attachment to the link 54.
`
`In one embodiment, spacer 10 and delivery device 80 are
`positioned in a first orientation as illustrated in FIG. 11. A
`longitudinal axis 300 of the spacer 10 forms an acute angle or
`with a longitudinal axis 200 of the delivery device 80. This
`orientation provides for the footprint of the spacer 10 to be
`reduced during the insertion procedure such that the spacer 10
`is positioned within the patient in a minimally invasive man-
`ner. In one embodiment, the longitudinal axis 300 is substan-
`tially aligned with the longitudinal axis 200 (i.e., angle (X is
`less than about 10 degrees).
`Once positioned between the vertebral members, spacer 10
`is pivoted relative to the delivery device 80 as illustrated in
`FIG. 15. The spacer 10 is pivoted relative to the delivery
`device 80 such that angle (X is increased from the first orien-
`tation. In one embodiment, angle (X is increased to between
`about 75 and 1 10 degrees. In one embodiment, articulation is
`caused by moving the first shaft 81 relative to the second shaft
`82. The holder 55 is connected to the second shaft 82 and
`relative movement ofthe first shaft 81 causes the holder 55 to
`
`pivot about pivots 90. The amount ofrelative movement ofthe
`shafts 81, 82 translates to the amount of articulation or angle
`of the spacer 10 relative to the delivery device 80.
`
`19 of 24
`19 of 24
`
`

`
`US 7,828,849 B2
`
`7
`The spacer 10 may be articulated relative to the delivery
`device 80 in a variety of different methods. In one embodi-
`ment illustrated in FIGS. 16 and 17, a member 299 is axially
`aligned with a proximal end of the shaft 82. In one embodi-
`ment, member 299 includes a threaded section and a non-
`threaded section. Proximal end ofthe shaft 81 includes exten-
`
`sions 131 positioned against the non-threaded section. The
`shaft 81 moves axially relative to the member 299. A drive
`sleeve 130 is connected to the shaft 81 and is positioned over
`the member 299. Drive sleeve 130 includes intemally-posi-
`tioned threads that mate with the threaded section of member
`299. Rotation of the drive sleeve 130 causes axial movement
`
`of the shaft 81 relative to the shaft 82 thus pivoting the spacer
`10. In one embodiment, drive sleeve 130 is attached to the first
`shaft 81 by a slip ring.
`Once properly articulated and positioned between the ver-
`tebral members, spacer 10 is deployed from the closed orien-
`tation towards the open orientation. A deploying means is
`positioned within the delivery device 80 to deploy the spacer
`10. In one embodiment, a cam 84 is positioned within deliv-
`ery device and includes a distal end adjacent to the end of the
`delivery device 80, and a proximal end positioned at the
`deployer 7. In one embodiment, cam 84 is positioned within
`the second shaft 82 and is axially moved through the delivery
`device 80.
`Movement of the cam 84 is illustrated in FIGS. 18 and 19.
`In the closed orientation, delivery device 80 is attached to the
`spacer 10 with the cam 84 in a first position and third member
`40 positioned at the proximal end of the spacer 10. Cam 84 is
`axially moved within the delivery device 80 to move the third
`member 40 towards the distal end of the spacer 10. A distal
`end ofthe cam 84 contacts a proximal end ofthe third member
`40 to push the third member 40 and deploy the spacer 10. The
`amount of axial movement ofthe cam 84 controls the amount
`of spacer deployment. Axial movement of the cam 84 from
`the first orientation to the second orientation causes the third
`member 40 to move relative to the first member 20 causing the
`angled sections to contact and increase the spacer height. The
`amount of movement of the cam 84 controls the amount of
`increase of spacer height. The cam 84 is operatively con-
`nected to the third member 40 meaning it may be attached to
`the third member 40, or unattached but placed in contact with
`the third member 40 during actuation.
`FIG. 22 illustrates another embodiment of the third mem-
`ber 40. This embodiment is similar to the previous embodi-
`ment illustrated in FIG. 4, with the addition of a lug 140 on a
`proximal end. Lug 140 includes a contact surface 142 that is
`contacted to the distal end of the cam 84 during the deploy-
`ment. FIG. 23 illustrates another embodiment of the cam 184
`having a distal end 185 that contacts the contact surface 142.
`In one embodiment, the distal end 185 is substantially per-
`pendicular with the side edges. The contact surface 142 and
`distal end 185 are shaped such that a contact angle E formed
`between the two surfaces is maintain as small as possible
`during the deployment. Additionally,
`there is a greater
`amount of contact between the distal end 185 and contact
`surface 142 during deployment. Cam 184 may have a variety
`of configurations, including a pushrod that extends along all
`or a section ofthe delivery device 80 a11d includes a distal end
`185 that contacts the spacer to deploy it to the expanded size.
`In an embodiment having only first and second members
`(i.e., no third member), the first member has angled surfaces
`that contact a second member having angled surfaces. Cam
`84 is positioned to contact one of the first or second members
`and provide relative movement for deployment.
`FIGS. 6 and 7 illustrate the movement of the third member
`40 caused by the cam 84. In one embodiment, third member
`40 is positioned proximally within the spacer 10 as illustrated
`in FIG. 6. Movement of the cam 84 moves the third member
`40 distally as illustrated in FIG. 7 causing the spacer 10 to
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`8
`deploy. One manner of reducing the spacer 10 is by moving
`the cam 84 proximally and pulling the third member 40.
`FIG. 1 illustrates one embodiment ofthe delivery device 80
`and deployer 7. Various types of deployers can be applied to
`the delivery device 80 to expand the spacer 10. The deployer
`may be positioned adjacent to the spacer 10, or positioned
`distant from the spacer 1 0 to be outside the patient. Previously
`filed U.S. patent application Ser. No. 10/178,960 entitled
`Minimally Invasive Expanding Spacer and Method, filed Jun.
`25, 2002 and assigned to the same entity as the present appli-
`cation, discloses deployers and structures for deploying the
`spacer towards the open orientation and is herein incorpo-
`rated by reference in its entirety.
`In one embodiment, deployer 7 is attached to a proximal
`end ofthe delivery device 80. Deployer 7 is attached to a lock
`89 that is attached to the cam 84. Dcploycr 7 provides axially
`movement of the cam 84 through the delivery device 80. In
`one embodiment, knob 302 includes a threaded connection to
`a contact member. Rotation of the knob causes the contact
`member to move outward relative to the knob 302. When the
`deployer 7 is mounted to the delivery device 80, contact
`member abuts against the proximal end of the lock 89. Rota-
`tion of the knob 302 causes the contact member to axially
`move the lock 89 and thus the cam 84.
`In one embodiment, the amount of axial movement of the
`cam 84 is controlled. FIG. 20 illustrates one embodiment with
`the lock 89 positioned an axial distance from the shaft 82 (i.e.,
`FIG. 20 illustrates the cam 84 in a retracted position). Move-
`ment ofthe deployer 7 causes the lock 89 and cam 84 to move
`axially relative to the shaft 82. The amount of movement is
`limited as the distal end of the lock 89 contacts the proximal
`edge ofthe shaft 82. Various other types of deploying mecha-
`nisms may be used for axially moving the cam 84 and deploy-
`ing the spacer 10.
`Delivery device 80 may be attached to the spacer 10 in a
`variety of different manners. In one embodiment, spacer 10 is
`connected through movable live pivots 90 that extend through
`apertures 37. The live pivots 90 connect the spacer 10 to the
`delivery device 80. In a detached orientation, live pivots 90
`are moved below the apertures 57 and the delivery device 80
`is detached from the spacer 10. One embodiment is illustrated
`with FIG. 21. Cam 84 extends through the delivery device 80
`and has an extended configuration with a first dimension
`larger than a second dimension. Pivots 90 are positioned
`adjacent to the cam 84. In the attached orientation, cam 90 is
`orientated with the larger dimension aligned relative to the
`pivots 90. The pivots 90 contact the cam 84 and extend out-
`ward through the apertures 57. In the detached orientation,
`cam 84 is ro