WO2013082184A1

WO2013082184A1 - Support device and method for use

Info

Publication number: WO2013082184A1
Application number: PCT/US2012/066891
Authority: WO
Inventors: E. Skott Greenhalgh; John-Paul Romano
Original assignee: Flexmedex, LLC
Priority date: 2011-11-28
Filing date: 2012-11-28
Publication date: 2013-06-06
Also published as: JP2015504344A; EP2785284A4; EP2785284A1

Abstract

Devices and methods for orthopedic support are disclosed. The device can have a first rigid section nested and unsecured to a second rigid section. Whether nested with one another or not, the device segments can be articulatably curved or rotated around obstructions along an access path to a target site. The device can be delivered to an intervertebral location in a patient.

Description

TITLE OF THE .INVENTION

SUPPORT DEVICE AND METHOD FOR USE

E. Skott Greenha!gh

John-Paul Romano

CROSS-REFERENCE TO RELATED APPLICATION

10001 ] This application claims priority to LIS. Provisional Application No. 61/564,105 filed 28 November 201 1 which is herein incorporated by reference in its entirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention67

[0002] A device or system, such as a .flexible spinal fusion cage or cages, which can articulate (bend) in such a way that the device or system can be implanted from a lateral approach into L4-L5 and L5-S1 is disclosed. 2. Description of the Related Art

[0003] Typical lateral approach fusion implants (e.g.. Discover X.LJF, by uVasive, Inc.. San Diego, CA; and the Direct. Lateral Interbody Fusion (DLIF) by Medtronic, Inc., Minneapolis, MN) are not able to implant their fusion cages for two reasons.

[0004] First, bcmey obstacles can impair access. Figures 1 a and 1 b illustrate the pelvis and lower spine including the ilium 2, sacrum SI , and lower lumbar vertebrae L3, L4 and L5. Figures 1 a and ib show the challenge of gaining lateral access to the L4-L5 and the L5-S 1 intervertebral spaces. The position of the Ilium 2 obstructs the direct la teral access pathway.

[0005] Figure 2 illustrates windows 4a and 4b or channels which some doctors create during implantation. The windows 4a and 4b are created through the Ilium to gain direct line of site access to the L4-L5 and L5-S 1 intervertebral spaces, respectively. This is a highly invasive approach, creates significant tissue damage, particularly to the Ilium and surrounding soft tissue, and requires significant surgical skill.

[0006] Second, the steep approach angle (8a for the 1.4-1.5 intervertebral space and 8b for the L5-S 1 intervertebral space), as measured from a transverse plane along the approach path (10a for the L4-LS intervertebral space and 10b for the L5-S 1 intervertebral space) of a tissue retractor relative to the location of the fusion site, can cause problems, as illustrated in Figures 3 and 4. The approach paths !Oa and 10b pass through the skin surface 12, The tissue retractor used in lateral fusion surgery provides Sine of site access to the disk space requiring a fusion cage insertion. The tissue retractor holds tissue out of the way of the procedure. The tissue retractor is also used to create a working channel to pass tools through, protect neural tissue, and anchor to the superior and inferior vertebral bodies relative the disk space requiring fusion. The volume within the pelvis and inferior to the dashed demarcation line 6 along a transverse plane is very hard if not impossible to reach with a direct, lateral approach due to the ilium. Even if the retractors are tilted as shown by the demarcation line 6. the ability to insert an implant that is the length of the end plates of the L.4 or L5 vertebral bodies would be very difficult due to obstruction of the Ilium among other factors.

J0007J Furthermore, with the retractor positioned along the approach path 1.0a or 10b plane and angled direction, the angle formed between the retractor and the vertebral body end plates would make inserting a monolithic, inflexible fusion cage 14 or implant into the L5- S 1 intervertebral space difficult if not virtually impossible due to obstruction of the surrounding hard and soft tissue, as illustrated by Figure 5a. A. typical lateral fusion cage or implant wid th .1 is the width of the end plate 18 along the adjacent disk. The implant 1 can not turn the comer at the pivot point 20 at the lateral and'or anterior edge of the 1.5- Si intervertebral space. SUMMARY OF THE INVENTIO

{0008] Support or fixation devices and methods for access, controlling (e.g., steering or rotating, and driving or translating) implants, and modifying the configuration of implants are disclosed. The device can be an implantable fixation device, such as a flexible and/or articulatable fusion cage or cages with unattached or detached component segments. The device can articulate and/or bend so the device can make the turn around the L5-S1 intervertebral space. The implant can fle and/or articulate and/or be assembled at the target site in vivo. For example, the implant can have hinges and/or be flexible (e.g., have significantly elastic structural components) and/or be nested and detached and/or abutting and unattached component segments.

{0009] Articulation tools are disclosed that can be used to implant the device. The articulation tools can articulate the device and/or allow the device to articulate. For example, the connection between the articulation tool and the implant can bend, flex, steer, or combinations thereof. The articulation tools can be used to debride or clear out the disk space. The articulation tools can hold the detached and'or abutting segments of the device together during delivery to and/or removal from the target site. The articulation tools can assemble or disassemble the device components in vivo at the target site or away .from the target site.

[0010] An oblique curved access tool or device can be used. The device can be delivered to the intervertebral space along an oblique approach path, not perpendicular to the spine, The oblique approach can provide an access path from lateral skin to the L5-S 1 disk space, and can curve tangent to the Ilium. A large working channel through die soft tissue can be created. The oblique access tool can move soft tissue out of the way to create the working channel The oblique approach can reduce the access-tool-to-disk-space approach angle.

[00111 A biological implant support device for providing orthopedic support is disclosed, The device ca be ariiculatable or flexible. The device can have a first rigid section or segment at a first terminal end of the device. The first rigid section can ha ve a first top plate and a first bottom plate. The device can have a second rigid section or segment having a second top plate and a second bottom plate. The first rigid section can be rotatably unattached to. and/or nested and detached from, and/or abutting to the second rigid section. The lop and bottom plates can be configured to interface with hard tissue,

[0012] A method for inserting a support device to a target site in a spine adjacent to a first vertebr is disclosed. The method can include creating a channel through a non-vertebral bone. The method can include inserting a first rigid section of the device through the channel and into the target site. The method can include inserting a second rigid section of the device through the channel, precedent to, simultaneously with or subsequent to inserting the first rigid section through the channel and into the target site. The method can include rotating the second rigid section of the implant with respect to the first rigid section. The first rigid section can be unattached to the second rigid section before, and/or during and'Or after delivery to the target site. The method can include the first rigid section abutting the second rigid section of the implant during delivery into the target site,

[0013] Creating the channel can include drilling the tissue with a flexible drill. The non- vertebral bone can be the pelvis, such as the ilium and/or the sacrum.

[0014] A. method for inserting an implant to a target site between a first vertebra and second vertebra is disclosed. The method can include creating a first channel through the ilium. The method can include creating a second channel through the sacrum. The first channel can be aligned with the second channel. The method can include inserting a first rigid section of the implant through the first channel and the second channel info the target site. The method can include rotating a second rigid section of the implant with respect to the first rigid section, wherein the first rigid section is unattached to and abutting the second rigid section during delivery to the target site. The method can include inserting the second rigid section of the implant into the target site. The second channel can pass through a port formed in vertebral endplate. The device can be inserted through the port in the vertebral endplate and articulate as the device is delivered into the target site. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Figures la and lb are anterior and lateral views, respectively, of the lower lumbar and sacral spine and pelvis with the Ilium shown ra phantom lines in Figure lb.

[ 016 j Figure 2 is a lateral view of the lower lumbar spine with windows cut through the Ilium.

[0017] Figures 3 and 4 are anterior and lateral views, respectively; of the lower spine and pelvis along with approach paths into the intervertebral spaces.

001 1 Figure 5a is an anterior close-up view of the lower spine and pelvis with an approach of a monolithic implant,

[0019] Figure 5b illustrates a variation of the implantable device,

{0020] Figures 5c and 5d illustrate a variation of a method of delivering the de vice oi^¬ Figure 5b into the L5-S 1 space.

[0021| Figures 6 through 8 are anterior, perspective and lateral views, respectively, of a variation of the approach path for delivering the implant into the intervertebral space.

[0022] Figure 9 illustrates a top view of a variation of the device in a nested configuration.

[0023] Figures 10a through !Od are side perspective, top, side, and top-side quarter perspective views, respectively, of the variation of the device of Figure 9 in a spaced-apart configuration.

[0024] Figure 1 la is a variation of cross-section A-.A.

[0025] Figures 1 lb, 1 lb' and 1 lb" are top-side quarter perspective, top and side perspective views, respectively, of a variation of cross-section B-B.

[0026] Figure 11c is a variation of cross-section C-C.

[0027] Figures 12a through 12d are top, side proximal end and distal end views, respectively, of the variation of the device of Figure 9 loaded in a straight nested configuration on a delivery tool.

[0028] Figure 13 is a variation of cross-section D-D,

[0029] Figure 14 is a distal end perspective view of the variation of the device of Figure 9 in a nested configuration. [0030 j Figure 15 is a variation of cross-section E-E.

[00311 Figure 1 is a distal end perspective view of the variation of the device of Figure 9 loaded in a straight nested configuration on the delivery tool.

[0032] Figure 17 is a variation of cross-section F-F.

[0033] Figures Ϊ 8a through 18e are distal end perspective, distal end perspective, top, side- top perspective and side views, respectively, of the variation of the device of Figure 9 in a curved or articulated nested configuration on the delivery tool.

[0034] Figures 19a and 1 b are side and perspective views, respectively, of a variation of cross-section G-G.

[ 035 j Figures 20a and 20h illustrate a variation of the device in nested and spaced configurations, respectively.

[0036] Figures 21a and 21 b illustrate a variation of the device in nested and spaced configurations, respectively.

[0037] Figures 22a and 22h illustrate a variation of the device in nested and spaced configurations, respectively.

[0038] Figures 23a and 23b illustrate a variation of the device in nested and spaced configurations, respectively.

[0039] Figure 24 illustrates the lower spine and pelvis.

[0040] Figures 25 through 28 iliustrate a variation of a method of delivering the device to a target site.

[0041] Figures 29 through 31 illustrate views through the transverse plane from a superior location, the sagittal plane from a lateral location, and the coronal plane from an anterior location, respectively, of a variation of the location of the transosseous delivery channel.

[0042] Figure 32a is an anterior perspective view of a portion of the lower spine,

[0043] Figure 32b is a sagittal sectional view of the portion of the lower spine of Figure 32a with the transosseous delivery channel formed and a discectomy performed creating a voice int he intervertebral disc space.

[0044] Figure 33 illustrates a method for delivering the device into the void in the intervertebral disc space.

[0045] Figure 34 illustrates section H-H of Figure 33.

[0046] Figure 35 illustrates a method for delivering the device into the void in the intervertebral disc space without the delivery tool, or after the delivery tool has been removed from the transosseous delivery channel.

[0047] Figure 36 illustrates section Ϊ-Ι of Figure 35. [0048J Figure 37a through 37c are anterior perspective views of the device in variations of configurations and positions in the discectomy void of the L5-S1 intervertebral space.

[0049] Figures 38a and 38b are perspecti ve and superior views., respecti vely of the device delivered in vivo to the target site and positioned longitudinally aligned with the channel exit port and aio g the posterior portion of the L5-S 1 space,

[0050 j Figures 39a and 39b are perspective and superior views, respectively of the device delivered in vivo to the target site and positioned longitudinally unaligned with the channel exit port and along the anterior portion of the L5 -S 1 space. DETAILED DESCRIP TION

[OOSlj Support or fixation devices 14 and methods for access, controlling (steering) implants, and modifying implants are disclosed. The support device disclosed herein ca be used to treat one or more osseous structures in the body including the L4-L5 and L5-S1 region of the spine. The device can be used with known methods of accessing the vertebrae of the spine such as the L4-L5 and L5-S1 regions with posterior, anterior, or lateral approaches, or combinations thereof.

[0052] The device 14 can be an implantable fixation device, such as a flexible fusion cage, The device can be delivered into an intervertebral space, for example, to provide structural support between the adjacent vertebrae. The device can fuse the vertebra adjacent to the specific intervertebral space, A discectomy can be performed at the target implant site before or during delivery of the implant.

[0053j Figures 5a through 5c illustrate that the device can be artieulatable or flexible during delivery to the target site. The implantable device 14 can be used to support and/or fix structures between adjacent vertebrae, such as between the L4 and L5 vertebrae or between the L5 and SI vertebrae. The implantable device 14 can be artieulatable and/or flexible so as to navigate sharp anatomical turns, such as the L4-L5 or L5-S1 intervertebral space. The implantable device 1.0 can be rigidly lockable or can remain flexible or attic datable at all times. The implantable device 10 can be rigidly locked for example using a delivery tool, e.g., wires, sheaths, guides, or combinations thereof for example, for additional stability. Such surgical delivery tools, alone or in combination, may add axial strength and stability before during or after pressing the implantable device 10 into the targeted intervertebral disc space.

[005 1 Figure 5b illustrates that the implantable device 14 can have first, second, third, and fourth segments 22a through 22d. Each of the segments 2.2a, 22b, 22c, and 22d can be unattached, and/or nested and detached to, and/or mterdigitating and unconnected and unjoined to the adjacent segment at a flex point or artieulatable hinge 24a. 24b, and 24c, respectively. The device 14 can articulate and/or bend at the hinges 24.

[0055] Figures 5c and 5d illustrate that the device 14 can be delivered into the L5-S 1 intervertebral space. The device Ϊ 4 can make the tarn around the L5-S 1 intervertebral space, such as at the pivot point 20. by articulating or flexing.

[0056] Figures 6 through 8 shows illustrate a curved implant pathway or approach pat 10c. An articulation tool can be used to pus (e.g., impact), pull, control or combinations thereof, the implant 14. The implant 1 can articulate and/or flex during delivery. The implant can have single or multiple hinges, a flexible shaft, laser slots (e.g., in a tube to act as hinges) or combinations thereof.

[0057] The approach pat 10c can be tangential to the media! surface of the ilium along a portion of the length of the approach path 10c. A portion of the length of the approach path 10c can be linear and a portion of the length of the approach path 10c can be curved. The entire approach path IOc can be linear or curved. A portion of the length of the approach path 10c can track (i.e., follow the same shape of) the medial surface of the Ilium. The approach path 10c can contact the medial surface of the Ilium 2, The approach path I Oc can be non-perpendicular or perpendicular to the longitudinal axis 27 of the spine where the approach path 10c enters the intervertebral space L4-L5 or 1,5-S I .

[0058] The approach-Ilium gap 26 can be measured between the approach path 10c and the closest medial surface of the Ilium 2. The approach-Ilium gap 26 can be perpendicular to the approach path 10c and the ilium 2. for example when the approach path I Oc is tracking the media! surface of the Ilium 2. The approach -Ilium gap 26 can be from about 0 mm to about 15 mm along the length of the approach path I c where the approach path is tracking the media! surface of the ilium 2, more narrowly from about 0 mm to about 10 mm, yet more narrowly from about 2 mm to about 8 mm.

[0059] The approach path I Oc can be curved in all three dimensions (e.g., in the transverse plane, sagittal plane and coronal plane), or any combination thereof and straight in the remaining dimensions.

[0060] Figure 9 illustrates that the device can have segments that can be curved, lordotic, or combinations thereof. For example, a device can have a mixed and matched

combination of segments selected, for example by the doctor during the procedure, for patient-specific anatomy. The segments can be impacted into position through a direct access approach, a MIS approach, lateral, posterior, or transosseous approaches, or combinations thereof. For example, various segments of the same device can be deli vered through various approaches to the same target site.

[0061] The segments can be hinged (e.g., with out a pin or direct attachment) to adjacent segments. The segments can be held or pressed together during delivery to the target site. 0062] The device can have a support device nested length when the segments are abutting each other.

[0063] During use, the segments 22 can be introduced to the target site alone in single, spaeed-apart segments, or multiple, abutting segments. The abutting segments can be pre assembled into the device or constructed during the procedure as one or more segments.

[0064] The device 14 can be held together by the inserter too) (i.e., deployment tool) 200 during delivery. The device 14 can be detached and released f om the deployment tool after the device is delivered to the target site.

[0065] The segments 22 can be shaped or otherwise configured to nest or interdigitate with each other when the device is subjected to a longitudinal compressi ve load. For example the segments can abut at and rotate about the female and male abutments.

[0066] The device 14 can be longitudinally held together or tensioned, for example by the deployment tool 200. Once the device 14 is positioned in the bone tunnel, the device 14 can be translated along the bone channel and released from the deployment tool 200.

[0067] Figures 10a through !Od illustrate that the segments 22 can be separate and spaced apart from each other, for example by segment gap lengths. For example, the segments 22 can be held together (e.g., by a detachable deployment tool) during delivery to the target site, and then after deployment the segments can move away or break apart from each other or be released into indi vidual sections or parts.

[0068] The first segment 22a can have a first segment longitudinal axis 222a, The second segment 22b can have a second segment longitudinal axis 222b. The third segment 22c can have a third segment longitudinal axis 222c. The first, second and third longitudinal axes 222 can be aligned with each other in the vertical and/or longitudinal and/or lateral dimensions, for example while the segments 22 abut each other during delivery to the target site. The first, second and third longitudinal axes 222 can be misaligned with each other in the vertical and/or longitudinal and/or lateral dimensions, for example after the segments 22 are delivered to the target site, such as after the segments 22 have settled in the tar act site.

[0069] The device 14 can have a support device spaced length 224b when the segments 22 are spaced apart from each other. The support device nested length 224a can be short than the support device spaced length. The support device nested length can be from about 30 mm to about 45 mm (e.g., each segment can be from about 10 mm to about 15 mm in length). The support device spaced length can be from about 33 mm to about 125 mm, more narrowly about 90 mm to about 120 mm. for example about 105 mm.

[0070] The first segment 22a can be spaced from the second segment 22b by a first segment gap length. The second segment can be spaced from the third segment by a second segment gap length. The first and second segment gap lengths can be about zero when the segments are nested and abut each other, for example during delivery to the target site. The first and second segment gap lengths can increase after the segments are delivered to the target site and released from being held to each other, for example after delivery to the target site. The spaced gap lengths can be from about 1 mm to about 35 mm, more narrowly from about 20 mm to about 25 mm.

[0071] Any or each of the segments can have a female abutment, for example on the proximal longitudinal face of the segments,

[0072| Any or each of the segments can have a male abutment, for example on the distal longitudinal face of the segments.

[0073] The female abutments can ha ve female abutment radii of curvature. The male abutments can have male abutment radii of curvature. The female abutment radii of curvature can be equal to the male abutment radii of curvature. The female abutment radii of curvature can be from about 3 mm to about 25 mm, for example about 7 mm. The male abutment radii of curvature can be from about 3 mm to about 25 mm, for example about 7 ram.

[0074] The female and male abutments can be configured to act as a hinge and rotate against each other when the segments are nested against and abutting one another. The female abutments and adjacent male abutments can enable adjacent segments to rotate with respect to each other about a transverse or lateral axis 300 (as shown by arrow), vertical axis, longitudinal axis, or combinations thereof.

00751 Figures 1 1 a through 1 lc illustrate that the deployment tool interfaces on the segments can include cylindrical ports on the proximal and/or distal longitudinal ends of any or each segment. Each segment can have a portion of the respective segment's deployment tool interface on the proxiraal side of the respective segment port and a portion of the respecti ve segment's deployment tool interface on the distal side of the respective segment port. Any or all of the deployment tool interfaces, such as the distal-most

deployment tool first interface, can have a segment thread and/or other interface detaehability configuration, configured to attach to and detachabiy release from the deployment tool.

[0076] Figures 12a through 12d illustrate that a deployment tool can be located in the nested or separated segments. The deployment tool can have an elongated deployment tool shaft. The deployment tool shaft can be rigid or flexible, and resilient or deformable. The depioymem tool shaft can be steerable (e.g., with an internal steering cable). The deployment tool can have a deployment tool head at the distal terminal end of the deployment tool. The deployment tool head can have an atraumatic (e.g., rounded or partially spherical) ternima! end.

[0077j The depioymem tool 200 can have a configuration for detachabiy securing to one or more of the segments. For example the deployment tool can have deployment tool thread at the distal end adjacent and proximal to the deployment tool head. The deployment tool thread can screw into the segment screw.

[007 J The deployment tool 200 can have a deployment tool hex at the proximal terminal end of the depl oy ment tool and/or proximal of the device. The deployment tool hex can be a configuration for attaching to a longer handle (not shown) of the deployment tool and other operating controls. The deployment tool hex can be rotatably fixed to a handle.

[0079] Figures 13, 16 and 17 illustrate that the deployment, tool shaft, can be slidably engaged by the deployment tool first and second interfaces. When the device is in a straight configuration, the deployment tool shaft can be abut or be spaced apart from the deployment tool first and/or second interfaces. The deployment tool shaft can be threadably engaged at the deployment tool thread with the segment thread at the distal end of the first seamen

[00801 Figures 14 and 15 illustrate that when the deployment tool 200 can be located not with the device 14. The deployment tool interfaces can form a hollow channel along or parallel with the longitudinal axis of the device 14. The device 14 can have a lordosis angle 302 formed by the intersection of the plane of the top plate 300a and the plane defined by the bottom plate 300b. For example the lordosis angle of the device or any of the segments 22 can be about from about 0° to about 15°.

f 0081] Figures 18a through 18e illustrate that device 14 can articulate. The segments 22 can rotate with respect to each other about the transverse or lateral (as shown), vertical, longitudinal axes (as shown), or combinations thereof.

[0082] Figures 1 a and 19b illustrate that the deployment tool shaft can deform. The deployment shaft can actively deform (i.e., controlled by a force exerted from a controlled source, such as a tensioning or steering wire or rail located in or attached to the deployment tool) and/or passively deform (i.e. , controlled by a force exerted from the surrounding anatomy, such as a result of a normal force from a bone into which the device is being pressed).

[0083] The device 14 can articulate as a result of th tool shaft deformation or causing the tool shaft deformation. For example each segment can articulate with respect to the adjacent segment.

10084] The proximal end of the deployment tool shaft can abut the proximal portion of the deployment tool third interface. The deployment tool shaft can contact and exert a force directly onto the deployment tool third interface. The deployment tool shaft can avoid directly contacting (as shown), or can contact, the deployment tool second interface.

[0085] The deployment tool shaft radius of curvature can be from about 0 mm (i.e. , forming a sharp, discrete angle) to a flat, lack of curvature (i.e., an infinite radius of curvature ), more narrowly from aboiri iOmm to about 30 mm. The radius of curvature for the device can be about equal to the deployment tool shaft radius of curvature.

[0086] The device 14 can have a deployment tool interface, such as the lateral hole 56, for attaching to the deployment tool.

[0087] A tensioning or steering wire or rail can be located within or outside of the deployment tool, such as within the deployment shaft. The steering wire can be deployed through the deployment tool interfaces (e.g., channels 32) on each segment. The wire can then be tensioned to articulate and/or lock the device 34 in an articulated configuration before delivery to the target site and/or while fine positioning the device (e.g., after translations! delivery) within the target site.

[0088] Figures 20a and 20b illustrate that the segments 22 can break up from each other, breaking up the device 14 into separate segments 22 that are not in direct contact. The segments 22 can be connected to each other by segment connectors 202, such as starts or ties. The segments 22 can be made from typical, durable orthopedic materials. The segment connectors 202 can hold the segments 22 to each other (e.g., which can help pushing the implant 14 into position, for example connected shorter links can bend around corners). The segment connectors 202 can be destruetable (e.g., biodegradable, electrically ablatable) starts or perforations which can tear easily when torque or tension is applied to the proximal end of the implant 14.

[00891 Figures 2 !a and 21b illustrate that the segments 22 can break up. The device 14 can have slits 204 or slots between each segment formed by the segment connectors 202. The segments 22 can separate at the integrated, and optionally weakened or perforated, base of the slits 204.

[0090] Figures 22a and 22b illustrate that the segments 22 can come apart. The segments 22 can have balls 206 extending therefrom and sockets 208 or socket-like configurations. When the device segments 22 are in column (i.e., longitudinal) compression, the segments 22 can nest with each other like a ball 206 and socket 208 assuring device stability during delivery of the device 14 to the target site. When the compressive force is remo ved, the device segments 22 can move apart, for example, without a hinge, connection, or joint. A hinge joint can have no pin and. no hard connection. The joint between adjacent, segments 22 can maintain a joint or connection when bent, but will release when in a straight form, The ball 206 and socket 208 can snap together and apart.

0091] Figures 23a and 23b illustrate that the segments 22 can be released from a tensioning element. The segments 22 can have a wire channel 210 or tool channel therethrough. The device 14 can have a tensioning and/or steering wire 212. The terminal distal end of the steering wire 212 c an have an end ball 214. The devices 14 can have a wire 212 or pin running through each segment of the implant, and connecting to the distal tip of the implant 14. For example, the wire 212 can have a removable or collapsible end ball 214. The end ball 214 can abut, and interference fit. with the distal end of the most- distal segment 22a. The proximal end and the sections between the segmen ts of the implant can commiraicate leveraging a compression-stable ball and socket, or cylinder in socket (e.g.. to resist torque, allow planar rotation, for example for bending only). The wire 212 can extend through a delivery tool handle. The wire 212 can be threadably attached to the distal end of the dev ice. The w ire 12 can be press fitted, like a slotted key way, a ball in cylinder (e.g., like a gym weight pin system), latch, hook, or combinations thereof.

[0092] The wire 212 can hold the implant segments together and provide tension through the implant. The wire can be made from a flexible material like Nitinol or any flexible material listed herein such as, polymer, spring steel, or combinations thereof. The wire 212 can bend with the implants individual segments 22 while the implant 14 is pushed into a final implanted location. With the implant 1 in a final interbody position, the wire 212 can help remove the segments 22 in their entiret (e.g., a tensile load can be applied to the implant) and/or the wire 2 2 can be removed (e.g.. unscrewed, detached, unlatched, un~ hooked, pulled out) from the tool handle outside the patient, and the implants single or multiple segments .22 can be released from the wire 212. [00931 PCX Application No. PCT US 1 1/00974 filed 27 May 201 1 which claims priority to U.S. Provisional App. No. 61/349,151 filed 27 May 2010 are both herein incorporated by reference in their entireties,

{0094] Any or all elements of the device and/or other devi ces or apparatuses described herein can he made from., for example, a single or multiple stainless steel alloys, nickel titanium alloys (e.g., Nitmol), cobalt-chrome alloys (e.g.. ELGILOY® from Elgin

Specialty Metals, Elgin, IL; CONICHROME® from Carpenter Metals Corp., Wyomissing, PA), nickel-cobalt alloys (e.g., MP35N® from Magellan Industrial Trading Company, inc., Westport, CT), molybdenum alloys (e.g., molybdenum TZM alloy, for example as disclosed in International Pub. No. WO 03/082363 A2, published 9 October 2003, which is herein incorporated by reference in its entirety), tungsten-rhenium alloys, for example, as disclosed in International Pub. No. WO 03/082363, polymers such as polyethylene teraphathahte (P£T)/polyester (e.g., DACRON® from E. 1. Du Pont cle Nemours and Company. Wilmington. DE), polypropylene, (PET), poSytetrafTuoroethySene ( PTFE), expanded PTFE (ePTFE). polyether ketone (PE ), polyether ether ketone (PEEK), poly ether ketone ketone (PEKK) (also poly aryl ether ketone ketone), nylon, polyether-biock co~polyamide polymers (e.g.. PEBAX© from ATOFINA, Paris, France), aiiphatfc polyether poiyurethaoes (e.g., TECOFLEX® from Thermedics Polymer Products, Wilmington, MA), polyvinyl chloride (PVC), polyurethane, thermoplastic, fluormated ethylene propylene (FEP), absorbable or resorbable polymers such as polyglycolic acid (PG A), polylactic acid (PL A), polycapro lactone (PCL), poly ethyl acrylate (PEA), polydioxanone (PDS), and pseudo-polyamino tyrosine-based acids, extruded collagen, silicone, zinc, echogenie, radioactive, radiopaque materials, a hiomaterial (e.g., cadaver tissue, collagen, allograft. autograft, xenograft, bone cement, morseiized bone, osteogenic powder, beads of bone) any of the other materials listed herein or combinations thereof Examples of radiopaque materials are barium sulfate, zinc oxide, titanium, stainless steel, nickel-titanium alloys, tantalum and gold.

[0095] Any or ail elements of the device and/or other devices or apparatuses described herein, can be, have, and/or be completely or partially coated with agents and/or a matrix a matrix for cell ingrowth or used with a fabric, for example a covering (not shown) that acts as a matrix for cell ingrowth. The matrix and/or fabric can be. for example, polyester (e.g., DACRON© from E. I. Du Pont de Nemours and Company, Wilmington, DE),

polypropylene. PTFE, ePTFE, nylon, extruded collagen, silicone or combinations thereof [009 j The device and/or elements of the de vice and/or other devices or apparatuses described herein and/or the fabric can be filled, coated, layered and/or otherwise made with and/or from cements., fillers, glues, and/or an agent deliver matrix known to one having ordinary skill in the art and/or a therapeutic and/or diagnostic agent. Any of these cements and/or fillers and/or glues can be osteogenic and osteoinductive growth factors.

[00971 Examples of such cements and/or fillers includes bone chips, demraeralized bone matrix (DBIVI), calcium sulfate, coralline hydroxyapatite, biocoral, tricalciura phosphate, calcium phosphate, polyraeihyl methacryiate (ΡΜΜΑ), biodegradable ceramics, bioactive glasses, hyaluronic acid, !actoferrin, bone morphogenic proteins (B Ps) such as recombinant human bone morphogenetic proteins (rhBMPs), other materials described herein, or combinations thereof.

[0098] The agents within these matrices can include any agent disclosed herein or

combinations thereof, including radioactive materials; radiopaque materials; cytogenic agents; cytotoxic agents; cytostatic agents; thrombogenic agents, for example polyureihane, cellulose acetate polymer mixed with bismuth trioxide, and ethylene vinyl alcohol;

lubricious, hydrophiiic materials; phosphor cholene; antiinflammatory agents, for example non-steroidal anti-inflammatories (NSAIDs) such as cye!ooxygenase-! (COX-1) inhibitors (e.g., acefylsalicylic acid, for example ASPIRIN® from Bayer AG, Leverkusen, Germany; ibuprofen. for example ADVIL® from Wyeth, CoUegeville, PA; indomethacin; mefenamic acid), CQX-2 inhibitors (e.g., ΥΪΟΧΧΦ from Merck & Co., Inc., Whitehouse Station, J; CELEBREX® from Pharmacia Corp., Peapaek, J; CGX-1 inhibitors);

immunosuppressive agents, for example Siroliraus (ΚΑΡΑΜϋΝΕ , from Wyeth,

CoUegeville, PA), or matrix metalloproteinase (ΜΜΡ) inhibitors (e.g., tetracycline and tetracycline derivatives) that act early within the pathways of an inflammatory response, Examples of other agents are provided in Walton et al. Inhibition of Prostaglandin E? Synthesis in Abdominal Aortic Aneurysms, Circulation, July 6. 1999, 48-54; Tarabiah et ah Provocation of Experimental Aortic Inflammation Mediators and Chlamydia

Pneumoniae, Brit. J. Surgery 88 (7). 935-940; Franklin et al. Uptake of Tetracycline by Aortic Aneurysm Wall and Its Effect on Inflammation and Proteolysis, Brit. J. Surgery 86 (6), 771 -775; Xu et al, Spl Increases Expression of CycIooxygenase-2 in Hypoxic Vascular Endothelium, J. Biological Chemistry 275 (32) 24583-24589; and Pyo et al, Targeted Gene Disruption of Matrix Metalloproieinase-9 (Geiatinase B) Suppresses Development of

Experimental Abdominal Aortic Aneurysms, J. Clinical Investigation 105 (1 1). 1641-1649 which are all incorporated by reference in their entireties. METHODS OF USE

[0099] Figure 24 illustrates that a straight or curved transosseous delivery channel 94 can be drilled, chiseled, punched, or a combinatio thereof, through the iliac bone 2 and/or the sacral aia 90. for example passing through the sacroiliac joint 92. The transosseous delivery channel 94 have a first length or first channel through the iliac 2 and a second length or second channel through the sacrum Si , The first, length of the transosseous delivery channel 94 can he aligned with the second length of the transosseous delivery channel 94, for example to form a substantially continuous channel. The transosseous delivery channel 94 can have a laterally- located channel entry port 96 laterally outside of the sacral ala 90 and/or iliac bone 2. The transosseous delivery channel 94 can have a channel exit port 98 adjacent to the L5-S1 intervertebral disc space. For example, the channel exit port 98 can be in the SI endplate. The channel exit port 98 can be positioned so the circumference of the channel exit port 98 tangentiaily coincides with or is closely adjacent to (e.g., within about 2 era. more narrowly within about 3 cm. more narrowly within about 5 mm, yet more narrowly within about 2 mm) with the edge of the SI vertebral endplate 100.

[0100] The L5-SJ intervertebral space can be partially or completely void of soft tissue, as shown, for example from a discectoray performed before insertion of the support device 14. For example, the discectomy can be performed by the method and device shown in U.S. Provisional Patent Application No. 61/526,630 filed 23 August 2 11 , which is incorporated by reference herein in its entirety.

[0101] Figure 25 illustrates that the support device 14 can be inserted, as shown by arrow 102, medially through the channel entry port 96 of the transosseous delivery channel 94. The device 14 can be removably and or articulatabl attached to a deployment tool shaft 104.

[0102] Figure 26 illustrates that the shaft 104 can be further translated, as shown by arrow 1 6, into the transosseous delivery channel 94. The support device 14 can translate toward and into the L5-S1 intervertebral disc space. The distal rip of the support device 14 can enter the L5-S 1 intervertebral disc. The support device 14 can enter the target site of the L5-S 1 intervertebral disc directly from the transosseous delivery channel 94 without passing through any soft tissue between the L5-S1 intervertebral disc and the iliac bone 2, [01031 Figure 27 illustrates that the shaft 04 can be further translated, as shown by arrow 108, medially through the transosseous delivery channel 94. The device 1 can translate., as shown by arrow 1 10, through the L5-S1 intervertebral disc space and the L5 and/or the Si vertebra. The support device 14 can articulate, as shown by arrow J 2. The nested hinges can rotate, articulating the segments 22. The hinges can passively rotate or c an be con trolled by the deploy ment tool, for example, by controls on the handle of the deployment tool (of which the shaft 104 is a part). The segments can be inserted through the transosseuous channel and to the target site individually or together in one or more groups.

{0104] The support device 14 can then be further translated, such as being pushed and/or vibrated (e.g., manually, idtrascmically), for example, medially and laterally, and/or superior and inferiorly, and or anteriorly and posteriorly. The through ports and or cavities and/or recesses 50 in the device 14 can be partially and/or completely filled bone morphogenic protein, therapeutic agents, other materials listed herein or combinations thereof. The support device 14 can deliver a cauterizing electrical energy from the deployment tool. The support device 14 and shaft 104 can have one or more longitudinal lumens that can be used to irrigate (e.g., with analgesic agents, saline, anesthetic agents. bone morphogenic proteins, visualization agents, other agents described herein, or combinations thereof} and/or aspirate (e.g., to remove irrigated material and/or debris) the target site (e.g., the L5-SJ intervertebral disc space).

[0105| Figure 28 illustrates that before, during or after the support device 14 is positioned in the L5-S1 intervertebral space, the shaft 104 can detach from the support device 14 and be translated laterally, as shown by arrow 1 14, from the L5-S! intervertebral disc space and the transosseous delivery channel 94. The deployment tool shaft 1 4 can remove or reposition the support device 14, any individual segment or groups of segments, or leave the support device 14 in place in the L5-S1 space.

[01 6] The method shown in Figures 25 through 28 can be repeated to deliver multiple support devices 14, and/or multiple segments or groups of segments sequentially, to one or more intervertebral spaces. For example, one, two, three or more support devices 14 can be positioned in the L4-L5 intervertebral space and/or the L5-S 1 intervertebral space. The one, two, three or more support devices 14 positioned in the L4-LS and/or LS-S S intervertebral spaces, can mechanically support the adjacent vertebrae and/or fix the adjacent vertebrae to each other. Bone ingrowth can occur through the through ports 50, for example fusing the support devices 14 to the respecti ve surrounding vertebrae.

[0107] Figures 29 through 31 illustrate that the transosseous delivery channel 94 can have a coronal delivery angle 120 measured to the coronal plane 122, a sagittal delivery angle 124 measured to the sagittal plane 126, and a transverse delivery angle 128 measured to the transverse plane 130. The coronal delivery angle 120 can be .from about 0° to about 25°. for example about 12°, The sagittal delivery angle 124 can be from about 65° to about 90°, for example about 75°. The transverse delivery angle 128 can be from about 0° to about 20°. for example about 10°. The support devic 14 and shaft 104 can be configured so the support device 14 can exit the channel exit port 98 (e.g.. directly into the L5-S1 intervertebral disc) and articulate sufficiently to enter and pass through all or a significant portion (e.g.. more than about 40%, yet more narrowly more than about 50%, yet more narrowly more than about 75%) of the width of the L.5-S1 intervertebral space.

[0108] Figures 30 and 31 show one or both femurs 132 for illustrative purposes.

[0109 j Figure 32a is an anterior view of a portion of the lower spine. The iliac bone 2 can ha ve the channel entry port 96 at the lateral end of the transosseous deli very channel 94 drilled or otherwise formed to extend through the iliac 2.

[0110 J Figure 32b is a sagittal sectional view of the portion of the Sower spine of Figure 32a with the transosseous delivery channel 94 formed and a discectoray performed creating a void 100 in the intervertebral disc space.

[0111] Figures 33 and 34 illustrate that the device 14 can be delivered to the L5-S1 intervertebral target site in the void 100 created by a dtscectomy. The deployment tool 200 can be removably attached to the device 14. For example, the deployment tool 200 can have radially external threads at the distal terminal end of the deployment 200 that can threadably engage with radially internal threads at the distal terminal end of the device 14, such as in the first segment 22a.

[01.12] The device 14 can be articulated and translated (as shown by arrows 1 6 and ! 98, respectively) along the transosseuos delivery channel 94 and into the target site. The translation and/or articulation forces or toques can be transmitted through the deployment tool 200 to the device 14. The device 14 can make the turn from the channel 94 to the disc space 1 0 without jamming or plowing into (e.g., not damaging the end plate in an atraumatic delivery) the 1.5 or SI end plates.

[0113] Figures 35 and 36 illustrate that the deployment tool 200 can be detached from the device 14 and removed from the target site, or that the segments 22 can be delivered to the target site 100 without a deployment tool 200. The segments 22 can be released (e.g., to "open" the device) or detached from each other after implantation or delivery to the target site 100 (e.g.. by detachment and removal of the deployment tool 200). Once released in the target site, the segments 22 can passively iranslationally ami artleulatably (e.g.. angularly) settle into desired positions within the intervertebral disc space.

[0114] Figures 37a through 37c illustrate that the device 14 can be delivered without rupturing, damaging or contacting the disc annulus, The annulus can be released (i.e.. altered) b the surgeon, for example for scoliosis correction. As the device 14 settles into the target site after implantation, the segments 22 can change articulation with respect to each other and remain nested or separate from each other by a gap distance. The segments 22 can posiiionally adjust to the anatomy and biomechanics of the patient without being attached and bound to the position of each other segments 22.

[0115] Figures 38a and 38b illustrate that the device 14 can be positioned in longitudinal alignment with the transosseous channel 94 and/or adjacent and/or partially or completely directly superior to the channel exit port 98. The device 14 can be on the posterior side of the intervertebral disc space.

[0116] Figures 39a and 39b illustrate that the device can be positioned longitudinally unaligned wi th the transosseous channel and or corapieteiy superiorly c lear of the channel exit port. The device can be moved away from the channel exit port during and/or after the segments of the device are delivered to the intervertebral disc space. The de vice can be positioned on the anterio side of the intervertebral disc space. The device can be in contact with the disc annulus.

[01ί 7) U.S. Provisional Patent Application No. 61/376,626, filed 24 August 2010, and 61/526,630, filed 23 August 2011 ; and PCT Application No. PCT/US201 1 /000874, filed 27 May 2011, PCT/US 1 1/48992, filed 24 August 201 1 ; and U.S. Patent Application No. .1 /686,775 filed November 27, 2012 are incorporated by reference herein in their entireties.

[0118] Any elements described herein as singular can be pluralized (i.e., anything described as "one" can be more than one). Any species element of a genus element can have the characteristics or elements of any other species element of that genus. The abo ve- described configurations, elements or complete assemblies and methods and their eieraents for carrying out. the invention, and variations of aspects of the invention can be combined and modified with each other in any combination.

Claims

We claim:

L A method for inserting an implant to a target site between a first vertebra and a second vertebra comprising:

creating a first channel throuuh the ilium;

creating a second channel through the sacrum, wherein the first channel is aligned with the second channel;

inserting a first rigid section of the implant through the first channel and the second channel into the target site,

rotating a second rigid section of the implant with respect to the first rigid section, wherei the first rigid section is unattached to the second rigid section; and

inserting the second rigid section of the implant into the target site.

2, The method of Claim 1 , wherein the second channel passes through a vertebral endplate,

3. A biological implant support: device for providing orthopedic support comprising;

a first rigid section at a first terminal end of the device, the first rigid section having a first top plate and first bottom plate; and

a second rigid section having a second top plate and a second bottom plate;

wherein the first rigid sectio is unattached to the second rigid section, and wherein the top and bottom plates are configured to interface with hard tissue.

4. A method for inserting a support device to a target she in a spine adjacent to a first vertebra comprising:

creating a channel through a non-vertebral bone and a vertebra! end plate;

inserting a first rigid section of the device through the channel and into the target site,

inserting a second rigid section of the device through the channel ,

rotating the second rigid section of the implant with respect to the first rigid section, wherein the first rigid section is unattached to the second rigid section; and

inserting the second rigid section of the implant into the target site.

5. The method of Claim 4, wherein creating the channel comprises drilling with a flexible drill.

6. The method of Claim 4. wherein the non-vertebral bone comprises the pelvis.

7. The method of Claim 4₅ wherein the non- vertebral bone comprises the ilium.

8. The method of Claim 4. wherein the non-vertebral bone comprises the sacrum.

9. A method for inserting a support device to a target site in a spine adjacent a first vertebra comprising;

creating a channel through a non-vertebra! bone and a vertebra; and

inserting the support device through the channel and into the target site.

10. A biological implant device for providing orthopedic support comprising:

a first rigid section with a first top plate and a first bottom plate; and

a second rigid section w ith a second top plate and a second bottom plate;

wherein the first rigid section is unattached to the second rigid section, and wherein the top and bottom plates are configured to interface with hard tissue; and

an elongated element, extending through the first rigid section and the second rigid section, wherein the elongated element is removably attached to the first rigid element.

1 1. The device of Claim 10_? wherein the elongated element is threadabiy attached to the first rigid element.

12. Th device of Claim 10, wherein the first rigid section has a curved proximal end and wherein the second rigid section has a curved distal end, and wherein the curved proximal end is configured to rotate in the curved proximal end.

13. The device of Claim 10, wherein the first rigid section is snap-connected to the second rigid section,