US20180368986A1 - Support device and method for use - Google Patents

Abstract

Devices and methods for orthopedic support are disclosed. The device can have a first rigid section hingedly attached to a second rigid section. The device can be 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

CROSS-REFERENCE TO RELATED APPLICATIONS
• This application is a continuation of U.S. patent application Ser. No. 14/874,150 filed Oct. 2, 2015, which is a continuation of U.S. patent application Ser. No. 13/773,100 filed Feb. 21, 2013, now abandoned, which is a continuation of PCT Application No. PCT/US2011/048992, filed Aug. 24, 2011, which claims priority to U.S. Provisional Patent Application No. 61/376,626, filed Aug. 24, 2010, and to U.S. Provisional Patent Application No. 61/526,630, filed Aug. 23, 2011, all of which are incorporated by reference herein in their entireties.
BACKGROUND OF THEINVENTION1. Field of the Invention
• A device, such as a flexible spinal fusion cage, which can articulate (bend) in such a way that it will be able to be implanted from a lateral approach into L4-L5 and L5-S1 is disclosed.
2. Description of the Related Art
• Typical lateral approach fusion implants (e.g., Discover XLIF, by NuVasive, Inc., San Diego, Calif.; and the Direct Lateral Interbody Fusion (DLIF) by Medtronic, Inc., Minneapolis, Minn.) are not able to implant their fusion cages for two reasons.
• First, boney obstacles can impair access.FIGS. 1aand 1billustrate the pelvis and lower spine including theIlium2, sacrum S1, and lower lumbar vertebrae L3, L4 and L5.FIGS. 1aand 1bshow the challenge of gaining lateral access to the L4-L5 and the L5-S1 intervertebral spaces. The position of the Ilium2 obstructs the direct lateral access pathway.
• FIG. 2 illustrateswindows4aand4bor channels which some doctors create during implantation. Thewindows4aand4bare created through the Ilium to gain direct line of site access to the L4-L5 and L5-S1 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.
• Second, the steep approach angle (8afor the L4-L5 intervertebral space and8bfor the L5-S1 intervertebral space), as measured from a transverse plane along the approach path (10afor the L4-L5 intervertebral space and10bfor the L5-S1 intervertebral space) of a tissue retractor relative to the location of the fusion site, can cause problems, as illustrated inFIGS. 3 and 4. Theapproach paths10aand10bpass through theskin surface12. The tissue retractor used in lateral fusion surgery provides line 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 thedashed demarcation line6 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 thedemarcation line6, the ability to insert an implant that is the length of the end plates of the L4 or L5 vertebral bodies would be very difficult due to obstruction of the Ilium among other factors.
• Furthermore, with the retractor positioned along theapproach path10aor10bplane and angled direction, the angle formed between the retractor and the vertebral body end plates would make inserting a monolithic,inflexible fusion cage14 or implant into the L5-S1 intervertebral space difficult if not virtually impossible due to obstruction of the surrounding hard and soft tissue, as illustrated byFIG. 5a. A typical lateral fusion cage orimplant width16 is the width of theend plate18 along the adjacent disk. Theimplant14 can not turn the corner at thepivot point20 at the lateral and/or anterior edge of the L5-S1 intervertebral space.
SUMMARY OF THE INVENTION
• 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. The device can articulate and/or bend so the device can make the turn around the L5-S1 intervertebral space. The implant can flex and/or articulate. For example, the implant can have hinges and/or be flexible (e.g., have significantly elastic structural components).
• 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.
• 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-S1 disk space, and can curve tangent to the Ilium. A large working channel through the 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.
• A biological implant support device for providing orthopedic support is disclosed. The device can be articulatable or flexible. The device can have a first rigid section at a first terminal end of the device. The first rigid section can have a first top plate and a first bottom plate. The device can have a second rigid section having a second top plate and a second bottom plate. The first rigid section can be rotatably attached to the second rigid section. The top and bottom plates can be configured to interface with hard tissue.
• A method for inserting a support device to a target site in a spine adjacent to a first vertebra 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. 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 hingedly attached to the second rigid section. The method can include inserting the second rigid section of the implant into the target site.
• 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.
• A method for inserting an implant to a target site between a first vertebra and a 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 into 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 hingedly attached to the second rigid section. 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
• FIGS. 1aand 1bare anterior and lateral views, respectively, of the lower lumbar and sacral spine and pelvis with the Ilium shown in phantom lines inFIG. 1b.
• FIG. 2 is a lateral view of the lower lumbar spine with windows cut through the Ilium.
• FIGS. 3 and 4 are anterior and lateral views, respectively, of the lower spine and pelvis along with approach paths into the intervertebral spaces.
• FIG. 5ais an anterior close-up view of the lower spine and pelvis with an approach of a monolithic implant.
• FIG. 5billustrates a variation of the implantable device.
• FIGS. 5cand 5dillustrate a variation of a method of delivering the device ofFIG. 5binto the L5-S1 space.
• FIGS. 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.
• FIGS. 9athrough 9dillustrate variations of the device in various configurations. An x-axis, y-axis and z-axis are also shown for orientation with the x-axis disposed along the longitudinal axis of the device.
• FIGS. 10aand 10billustrate various configurations of a variation of the device in a steering tube with the tube shown as see-through for illustrative purposes.
• FIGS. 10cthrough 10eillustrate various configurations of a variation of the device on steering rails attached to the lateral outside of the device.
• FIGS. 11athrough 11cillustrate various configurations of a variation of the device on a steering rail attached to the inside of the device.
• FIGS. 12athrough 12fare cross-sections of various steering rails, or along the length of the same steering rail.
• FIG. 13 illustrates a method for deploying the device into the L5-S1 intervertebral space.
• FIGS. 14aand 14billustrate various configurations of a variation of the device in a steering slide.
• FIGS. 15aand 15bare top and side views of a variation of the device with parallel hinges.
• FIG. 16 is a top view of a variation of the device with non-parallel hinges.
• FIGS. 17athrough 17fare side views of variations of the device.
• FIGS. 18 and 19 are perspective views showing the orientation of variations of living hinges within devices.
• FIGS. 20athrough 20care perspective, top and front views, respectively, of a variation of the device in a straight or flat configuration.
• FIGS. 21athrough 21care perspective, top and front views, respectively, of the device ofFIGS. 20athrough 20cin an articulated configuration.
• FIGS. 22athrough 22care perspective, top and front views, respectively, of a variation of the device in a straight or flat configuration.
• FIGS. 23athrough 23care perspective, top and front views, respectively, of the device ofFIGS. 22athrough 22cin an articulated configuration.
• FIG. 24 illustrates the lower spine and pelvis.
• FIGS. 25 through 28 illustrate a variation of a method of delivering the device to a target site.
• FIGS. 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.
• FIGS. 32athrough 32dillustrate a superior view of a variation of a method of delivering the device showing the iliac and sacrum, but not the L5-S1 disc or remainder of the spine for illustrative purposes.
• FIGS. 33athrough 33dillustrate a posterior perspective view of a variation of a method of delivering the device showing the iliac and sacrum, but not the L5-S1 disc or remainder of the spine for illustrative purposes.
DETAILED DESCRIPTION
• Support or fixation devices and methods for access, controlling (steering) implants, and modifying implants are disclosed. The support device disclosed herein can 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.
• The device 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.
• FIGS. 5athrough 5cillustrate that the device can be articulatable or flexible. The implantable device10 can be used to support and/or fix structures between adjacent vertebrae, such as between the L4 and L5 vertebrae or between the L5 and51 vertebrae. The implantable device10 can be articulatable and/or flexible so as to navigate sharp anatomical turns, such as the L4-L5 or L5-S1 intervertebral space. The implantable device10 can be rigidly lockable or can remain flexible or articulatable at all times. The implantable device10 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 device10 into the targeted intervertebral disc space.
• FIG. 5billustrates that theimplantable device14 can have first, second, third, andfourth segments22athrough22d.Each of thesegments22a,22b,22c,and22dcan be attached to the adjacent segment at a flex point or articulatable hinge24a,24b,and24c,respectively. Thedevice14 can articulate and/or bend at the hinges24.
• FIGS. 5cand 5dillustrate that thedevice14 can be delivered into the L5-S1 intervertebral space. Thedevice14 can make the turn around the L5-S1 intervertebral space, such as at thepivot point20, by articulating or flexing.
• FIGS. 6 through 8 shows illustrate a curved implant pathway or approach path10c.An articulation tool can be used to push (e.g., impact), pull, control or combinations thereof, theimplant14. Theimplant14 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.
• The approach path10ccan be tangential to the medial surface of the Ilium along a portion of the length of the approach path10c.A portion of the length of the approach path10ccan be linear and a portion of the length of the approach path10ccan be curved. The entire approach path10ccan be linear or curved. A portion of the length of the approach path10ccan track (i.e., follow the same shape of) the medial surface of the Ilium. The approach path10ccan contact the medial surface of theIlium2. The approach path10ccan be non-perpendicular or perpendicular to thelongitudinal axis27 of the spine where the approach path10centers the intervertebral space L4-L5 or L5-S1.
• The approach-Ilium gap26 can be measured between the approach path10cand the closest medial surface of theIlium2. The approach-Ilium gap26 can be perpendicular to the approach path10cand theIlium2, for example when the approach path10cis tracking the medial surface of theIlium2. The approach-Ilium gap26 can be from about 0 mm to about 15 mm along the length of the approach path10cwhere the approach path is tracking the medial surface of theIlium2, more narrowly from about 0 mm to about 10 mm, yet more narrowly from about 2 mm to about 8 mm.
• The approach path10ccan 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.
• FIG. 9athrough 9dillustrate that variations ofhinges24aand24bbetween thesegments22a,22band22ccan allow theimplant14 to articulate. Theimplant14 can have controlled angulation or articulation (i.e., with discrete, defined built-in stopping points or stops) or free angulation or articulation (i.e., with no stops).
• FIG. 9aillustrates that thehinges24aand24bcan be oriented in parallel with the z-axis. The hinges can have a single degree of rotational freedom. Thesegments24,24band24ccan articulate by rotating about the z-axis with respect to each other. The hinges24aand24bcan be near the top (as shown), near the bottom, in the middle with respect to the y-axis, or combinations thereof of thedevice14.
• FIG. 9billustrates that thehinges24aand24bcan be oriented in parallel with the x-axis. Thesegments24,24band24ccan articulate by rotating about the x-axis with respect to each other. The hinges24aand24bcan be near the front (as shown), near the rear, in the middle with respect to the z-axis, or combinations thereof of thedevice14.
• FIG. 9cillustrates that thehinges24aand24bcan be oriented in parallel with the y-axis. Thesegments24,24band24ccan articulate by rotating about the y-axis with respect to each other. The hinges24aand24bcan be near the front (as shown), near the rear, in the middle with respect to the z-axis, or combinations thereof of thedevice14.
• FIG. 9dillustrates that thehinges24aand24bcan be ball-in-socket hinges allowing three rotational degrees of freedom, or a combination of the three hinges described inFIGS. 9athrough9c,allowing two or three degrees of freedom. Thesegments24,24band24ccan articulate by rotating about the x-axis, and/or y-axis, and/or z-axis with respect to each other. The hinges24aand24bcan be near the front (as shown), near the rear, in the middle with respect to the z-axis, near the top, near the bottom, in the middle with respect to the y-axis (as shown), or combinations thereof of thedevice14.
• Thefirst hinge24acan be located in a different location and/or with a different than thesecond hinge24b.For example, thefirst hinge24acan be oriented in parallel with the z-axis, allow rotation about the z-axis and be located near the top of thedevice14, and thesecond hinge24bcan be oriented in parallel with the x-axis, allow rotation about the x-axis, and be located near the middle of thedevice14 with respect to the z-axis.
• FIGS. 10aand 10billustrate that thedevice14 can have an outer steering sheath ortube28. Thedevice14 can be fixed to thesteering tube28 or can slide along the steeringtube28. The steeringtube28 can be articulatable and/or flexible, as shown by the arrow inFIG. 10band the various configurations of thetube28 betweenFIGS. 10aand 10b. The articulation or flexion of the steeringtube28 can be controlled, for example by delivering controlled tension to tensile control wires in the walls of the steeringtube28.
• The steeringtube28 can be positioned at the target deployment site. For example, the steeringtube28 can be placed in the intervertebral space and can remain in the intervertebral space post-surgery, or the steeringtube28 can be removed from the intervertebral space and thedevice14 can be deployed from thetube28 and thedevice14 can be left in the intervertebral space.
• Also for example, the distal end of the steeringtube28 can be positioned at the entrance to the intervertebral space and/or rested on the inferior and/or superior vertebral body end plate adjacent to the target intervertebral space. Thedevice14 can then be pushed (e.g., by a plunger) out of the steering tube and into the intervertebral space. The steeringtube28 does not have to, but can, enter the intervertebral space.
• FIGS. 10cthrough 10dillustrate that thedevice14 can have one or more exterior steering rails, tracks orwires30aand30b,such as guidewires. Therails30aand30bcan slidably or fixedly and releasably engage the external surface of the segments22 of thedevice14. For example, the rails can pass through slots, guides, collars, cuffs or combinations thereof on the exterior of the segments22. The slots, guides, collars, cuffs or combinations thereof, and/or therails30aand30bcan be coated or covered with a low-friction (e.g., PTFE) or high-friction (e.g., knurled or toothed surface texturing) material or surface treatment or texture, including any of the materials listed herein. The steering rails30aand30bcan be steered or manipulated by applying a tensile force to tensile cables within the rails, as shown by the arrows inFIGS. 10dand 10e, and the flexing fromFIGS. 10cto 10d. Therails30aand30bcan be pre-formed to a specific shape and can be substituted forother rails30aand30bthat can be pre-formed to a different shape to change the direction of delivery.
• FIGS. 11athrough 11cillustrates that thedevice14 can have one or more interior steering rails, guide, tracks orwires30, such as guidewires. Therails30 can be positioned through the center or interior of one or more segments22 of thedevice14. Therail20 can slidably or fixedly and releasably engage an internal surface, such as through a longitudinal guide port orchannel32, of the segments22 of thedevice14. For example, ports or channels can extend longitudinally through the segments22 of thedevice14. The channels, and/or therail30 can be coated, covered or collared, such as with a low-friction (e.g., PTFE) or high-friction (e.g., knurled or toothed surface texturing) material or surface treatment or texture, including any of the materials listed herein. The steeringrail30 can be steered or manipulated by applying a tensile force to tensile cables within therail30, as shown by the flexing fromFIGS. 11ato 11c. Therail30 can be pre-formed to a specific shape and can be substituted for one or moreother rails30 that can be pre-formed to a different shape to change the direction of delivery.
• The distal ends of the internal and/or external steering rail or rails30 can be positioned at the target deployment site. For example, the steering rails30 can be placed in the intervertebral space and can remain in the intervertebral space post-surgery, or the steering rails30 can be removed from the intervertebral space and thedevice14 can be deployed from therails30 and thedevice14 can be left in the intervertebral space.
• Also for example, the distal end of the steering rails30 can be positioned at the entrance to the intervertebral space and/or rested on the inferior and/or superior vertebral body end plate adjacent to the target intervertebral space. Thedevice14 can then be pushed (e.g., by a plunger) out of the steering rails30 and into the intervertebral space. The steering rails30 do not have to, but can, enter the intervertebral space.
• FIGS. 12athrough 12fillustrate cross-sections ofvarious rails30, or at various lengths along thesame rail30.FIG. 12aillustrates that the cross-section of thesteering rail30 can be circular.FIG. 12billustrates that the cross-section of thesteering rail30 can be oval.FIG. 12cillustrates that the cross-section of thesteering rail30 can be multi-ovular (i.e., having a union of two or more ovals with the same major axis).FIG. 12dillustrates that the cross-section of thesteering rail30 can be the union of rectangles intersecting at right (or another) angle, such as a plus-sign.FIG. 12eillustrates that the cross-section of thesteering rail30 can be hexagonal.FIG. 12fillustrates that the cross-section of thesteering rail30 can be rectangular or square with sharp or rounded (chamfered) edges. The cross-section of thesteering rail30 can be triangular, pentagonal, heptagonal, or octagonal. The steeringrail30, whether internal or external to thedevice14, can deliver torque around the longitudinal and/or transverse axes of the device. The steeringrail30 can have various cross sections at various lengths along therail30. The steeringrail30 can guide, pitch, yaw and roll thedevice14 into a desired orientation or indication. Thedevice14 can be delivered with one or more internal and/orexternal rails30 and/or asheath28 or neither.
• FIG. 13 illustrates adevice14 that can be attached to a deployment tool having acontroller handle34 controllably attached to theinternal steering rail30. Theinternal steering rail30 can pass through thedevice14. The steeringrail30 can be fixedly attached to thedevice14 during the delivery and articulation of thedevice14. The device can be steered along or tracking the medial surface of theIlium2. Thedevice14 can then be positioned adjacent to the target site (e.g., the L5-S1 intervertebral space). The deployment tool can then release thedevice14 from the steeringrail30 and push thedevice14 into the target site.
• FIGS. 14aand 14billustrate that thedevice14 can be delivered by being pushed along a steering horn, boot, or slide36. Theslide36 can be similar to thesteering tube28, except that at least one wall of theslide36 can be missing or open (e.g., the top wall is not present in the variation of the slide shown) compared with the steeringtube28. The missing wall can be completely open or replaced by one or more steering rails30. Theslide36 can be used similar to the steering rails30 and/or steeringtube28. Theslide36 can be steered, flexed or articulated by applying a tensile force to tensile cables within the rails, as shown by the arrow inFIG. 14b, and the flexing fromFIGS. 14ato14b.
• FIGS. 15aand 15billustrate that thedevice14 can have sixsegments22athrough22fand five hinges24athrough24e.The segments22 can be attached to adjacent segments22 by one or more hinges, tension or steering rails or wires, screws, pins, or combinations thereof. The hinges24 can be pins. The segments22 can be chained together. The segments22 can be identical to each other except for thedistal-most segment22aand theproximal-most segment22f.The segments22 or links can be box-shaped. The hinges24, such as the pins, can be parallel to all or some of the other hinges24.
• FIG. 16 illustrates that thehinges24 can be at acute angles to all or some of the hinges24. The hinges24 can be at hinge angles38 with respect to each other. Thehinge angle38 can be measured between the hingelongitudinal axis40 and the devicelongitudinal axis42. The hinge angles38 can be from about 80° to about 150°, more narrowly from about 90° to about 135°, yet more narrowly from about 95° to about 110°.
• Thedevice14 can be translated and/or rotated by ahandle34 that can be removably attached to thedevice14. Thehandle34 can be screwed and/or snapped directly into the proximal end of thedevice14, such as into the proximal-most segment22. Thehandle34 can compress, such as by grabbing or pinching, the proximal end of thedevice14. Thehandle34 can be a pusher, plunger, ram, or combinations thereof. Thehandle34 and/or remainder of the deployment tool can be rigid and/or flexible or articulatable. For example, hinged similar to thedevice14.
• The segments22 are not necessarily connected to each other by hinges. The segments22 can be delivered to the target site individually, or as an unattached line of segments22.
• Thedevice14 can be cylindrical and flexible. Theimplantable device14 can be fully flexible all the time. Thedevice14 can be mechanically stabilized by the deployment tool, steering wires, sheaths, tubes and guides. For example, the tools, wires, sheaths, tubes and guides can provide column stability to press thedevice14 into the target site (e.g., intervertebral disc space).
• Thedevice14 can flexible, and then locked with a tension or steering wire to stop rotational motion of the hinges once the device is delivered to and oriented within the target site. The tension wire could be tightened, for example by being tensioned by a nut to create higher friction in eachhinge24.
• FIGS. 17athrough 17fillustrate that thedevice14 can have aliving hinge44. The livinghinge44 is a length of decreased rigidity and increased flexing within the body of thedevice14. The livinghinge44 can be formed around slots and continuous segments of otherwise tough, durable material. The livinghinge44 can be defined be narrowing or thinning in the body of thedevice14, such that the narrowing is sufficient to provide flexibility under reasonable torque. For example, the thickness of the unitary body of thedevice14 at the livinghinge44 can be narrowed by more than about 85%, or more than about 90%, or more than about 95%, or more than about 97%, or more than about 98.5%. The livinghinge44 can have one or more repeated thinnings along the length of thedevice14, as shown inFIGS. 17athrough17f.
• FIGS. 17aand 17billustrate that thedevice14 bends at the livinghinge44. The living hinges44 can be made to control the bend and direction of thedevice14. The outer surface of thedevice14 along the livinghinge44 can be smooth, for example providing low-friction surface for sliding over bone.
• FIGS. 17aand 17billustrate that the livinghinge44 can be along the bottom of theimplant device14.FIG. 17cillustrates that the livinghinge44 can be along the top of thedevice14.FIG. 17dillustrates that the livinghinge44 can be through the middle or central axis of thedevice14.FIG. 17eillustrates that the livinghinge44 is discontinuous and on opposite sides of the center of thedevice44.FIG. 17fillustrates that the livinghinge44 is at an angle with respect to the longitudinal axis of thedevice14, starting near the bottom of thedevice14 and ending near the top of thedevice14.
• FIG. 18 illustrates that the livinghinge42 can be at a non-zero angle to the centrallongitudinal axis42 of thedevice14. A first length of the livinghinge42 can be at a non-zero angle to a second length of the livinghinge44.
• FIG. 19 illustrates that the livinghinge44 can be curved. The livinghinge44 can curve around the centrallongitudinal axis42 of thedevice14.
• FIGS. 20athrough 20cillustrate that the device can have threesegments22a,22band22cconnected by twohinges24aand24b.The devicelongitudinal axis42 can be straight or can have a longitudinal radius ofcurvature46. The longitudinal radius ofcurvature46 can be from about 3 cm to about 100 cm, more narrowly from about 5 cm to about 20 cm, yet more narrowly from about 7 cm to about 15 cm, for example about 15 cm, also for example about 10 cm.
• Thesupport device14 can have asupport device width11a,asupport device length11band asupport device height11c.Thesupport device width11acan be from about 10 mm to 30 mm, or more narrowly 16 mm to about 18 mm. Thesupport device length11bcan be from about 30 mm to 60 mm, or more narrowly from 45 mm to about 55 mm. Thesupport device height11ccan be from about 1 mm to 30 mm, or more narrowly from 8 mm to about 16 mm.
• Thedevice14 can have an anterior taper or lordosis angle48. The taper angle48 can be measured between the plane of the top surface and the plane of the bottom surface of thedevice14. The taper angle48 can be from about 0° (i.e., parallel top and bottom planes) to about 45°, more narrowly from about 2° to about 20°, yet more narrowly from about 0° to about 12°, yet more narrowly from about 4° to about 10°, yet more narrowly from about 4° to about 8°, for example from about 0°, also for example about 6°.
• The first, second, and third links orsegments22a,22band22cof the flexibleimplantable device14 may be separate or connected. One or more of the segments22 can be rigid and/or flexible. One or more of the segments22 can have through-ports or segment ports50, such as first, second andthird segment ports50a,50band50c,through the first, second andthird segments22a,22b,and22c,respectively. The segment ports50 can extend through part of all of the height of the respective segment22 or thedevice14 from the top to the bottom surface. One or more of the segment ports50 can be partially or completely filled with a bone ingrowth matrix, bone morphogenic protein, therapeutic agents, any agent or material disclosed herein, or combinations thereof, for example for analgesic effect or to promote bone ingrowth.
• Thedevice14 can have a surface coating or texturing on the top, and/or bottom, and/or side surfaces, such aslateral teeth52, longitudinal or angled teeth, knurling, a coating or matrix to promote bone ingrowth, or combinations thereof.
• Thedevice14 can have hinge teeth orknuckles54. Thehinge teeth54 can slide byadjacent hinge teeth54 to increase lateral stability during articulation and increase range of motion (e.g., ahinge tooth54 on one segment22 can slide into the gap betweenhinge teeth54 on the adjacent segment22 during articulation of the device14).
• One or more tension and/or steering wires can be inserted and/or tensioned through guide ports orchannels32aand32b.Theguide channels32aand32bcan extend longitudinally through some or all of the segments22.
• Thefirst segment22aand thethird segment22ccan have centralvertical holes82aand82b,respectively. The central vertical holes82 can be attached to a deployment device, screwed to the adjacent tissue (i.e., bone) after delivery, filled with a radiopaque material for visualization or therapeutic or other material listed herein, or combinations thereof.
• FIGS. 21athrough 21cillustrate thatdevice14 can articulate. The segments22 can rotate with respect to each other about thehinges24, as shown by arrows.
• Thefirst segment22acan have a first segmentlongitudinal axis42a.Thesecond segment22bcan have a second segmentlongitudinal axis42b.Thethird segment22ccan have a third segmentlongitudinal axis42c.The respective longitudinal axes can intersect at the adjoining hinge pins24. The first segmentlongitudinal axis42acan form afirst articulation angle80awith the second segmentlongitudinal axis42b.The second segmentlongitudinal axis42bcan form asecond articulation angle80bwith the third segmentlongitudinal axis42c.The first and second articulation angles80aand80bcan be the same or different. When the device is in an articulated configuration, the first and/or second articulation angles80aand/or80bcan be from about 0° to about 90°, more narrowly from about 3° to about 75°, yet more narrowly from about 5° to about 60°, yet more narrowly from about 15° to about 45°.
• FIGS. 22athrough 22cillustrate that some or all of thedistal-most segments22athrough22dcan be identical. Segments22 can be added or removed from thedevice14, before during or after deployment to the target site, to increase or decrease the length of thedevice14 to best fit the target site. Thefalse hinge24′ can be a hinge component that is not attached to the other half of thehinge24. The hinges24 can snap together and apart. The articulation of each segment22 can be limited by the interference fit of arotational stop58 on the top and bottom of the adjacent segment22.
• Thedevice14 can have a deployment tool interface, such as thelateral hole56, for attaching to the deployment tool.
• FIGS. 23athrough 23cillustrate that a tensioning or steering wire orrail30 can be deployed through thechannels32 on each segment. Thewire30 can then be tensioned to articulate and/or lock thedevice14 in an articulated configuration.
• PCT Application No. PCT/US 11/00974 filed 27 May 2011 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.
• Any or all elements of the device and/or other devices or apparatuses described herein can be made from, for example, a single or multiple stainless steel alloys, nickel titanium alloys (e.g., Nitinol), cobalt-chrome alloys (e.g., ELGILOY® from Elgin Specialty Metals, Elgin, Ill.; CONICHROME® from Carpenter Metals Corp., Wyomissing, Pa.), nickel-cobalt alloys (e.g., MP35N® from Magellan Industrial Trading Company, Inc., Westport, Conn.), molybdenum alloys (e.g., molybdenum TZM alloy, for example as disclosed in International Pub. No. WO 03/082363 A2, published 9 Oct. 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 teraphathalate (PET)/polyester (e.g., DACRON® from E. I. Du Pont de Nemours and Company, Wilmington, Del.), polypropylene, (PET), polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), polyether ketone (PEK), polyether ether ketone (PEEK), poly ether ketone ketone (PEKK) (also poly aryl ether ketone ketone), nylon, polyether-block co-polyamide polymers (e.g., PEBAX® from ATOFINA, Paris, France), aliphatic polyether polyurethanes (e.g., TECOFLEX® from Thermedics Polymer Products, Wilmington, Mass.), polyvinyl chloride (PVC), polyurethane, thermoplastic, fluorinated ethylene propylene (FEP), absorbable or resorbable polymers such as polyglycolic acid (PGA), polylactic acid (PLA), polycaprolactone (PCL), polyethyl acrylate (PEA), polydioxanone (PDS), and pseudo-polyamino tyrosine-based acids, extruded collagen, silicone, zinc, echogenic, radioactive, radiopaque materials, a biomaterial (e.g., cadaver tissue, collagen, allograft, autograft, xenograft, bone cement, morselized 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.
• Any or all 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, Del.), polypropylene, PTFE, ePTFE, nylon, extruded collagen, silicone or combinations thereof.
• The device and/or elements of the device 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 delivery 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.
• Examples of such cements and/or fillers includes bone chips, demineralized bone matrix (DBM), calcium sulfate, coralline hydroxyapatite, biocoral, tricalcium phosphate, calcium phosphate, polymethyl methacrylate (PMMA), biodegradable ceramics, bioactive glasses, hyaluronic acid, lactoferrin, bone morphogenic proteins (BMPs) such as recombinant human bone morphogenetic proteins (rhBMPs), other materials described herein, or combinations thereof.
• 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 polyurethane, cellulose acetate polymer mixed with bismuth trioxide, and ethylene vinyl alcohol; lubricious, hydrophilic materials; phosphor cholene; anti-inflammatory agents, for example non-steroidal anti-inflammatories (NSAIDs) such as cyclooxygenase-1 (COX-1) inhibitors (e.g., acetylsalicylic acid, for example ASPIRIN® from Bayer AG, Leverkusen, Germany; ibuprofen, for example ADVIL® from Wyeth, Collegeville, Pa.; indomethacin; mefenamic acid), COX-2 inhibitors (e.g., VIOXX® from Merck & Co., Inc., Whitehouse Station, N.J.; CELEBREX® from Pharmacia Corp., Peapack, N.J.; COX-1 inhibitors); immunosuppressive agents, for example Sirolimus (RAPAMUNE®, from Wyeth, Collegeville, Pa.), or matrix metalloproteinase (MMP) 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 Prostoglandin E₂Synthesis in Abdominal Aortic Aneurysms,Circulation,Jul. 6, 1999, 48-54; Tambiah et al, Provocation of Experimental Aortic Inflammation Mediators and Chlamydia Pneumoniae,Brit. J. Surgery88 (7), 935-940; Franklin et al, Uptake of Tetracycline by Aortic Aneurysm Wall and Its Effect on Inflammation and Proteolysis,Brit. J. Surgery86 (6), 771-775; Xu et al, Sp1 Increases Expression of Cyclooxygenase-2 in Hypoxic Vascular Endothelium,J. Biological Chemistry275 (32) 24583-24589; and Pyo et al, Targeted Gene Disruption of Matrix Metalloproteinase-9 (Gelatinase B) Suppresses Development of Experimental Abdominal Aortic Aneurysms,J. Clinical Investigation105 (11), 1641-1649 which are all incorporated by reference in their entireties.
METHODS OF USE
• FIG. 24 illustrates that a straight or curvedtransosseous delivery channel94 can be drilled, chiseled, punched, or a combination thereof, through theiliac bone2 and/or the sacral ala90, for example passing through the sacroiliac joint92. Thetransosseous delivery channel94 have a first length or first channel through the iliac2 and a second length or second channel through the sacrum51. The first length of thetransosseous delivery channel94 can be aligned with the second length of thetransosseous delivery channel94, for example to form a substantially continuous channel. Thetransosseous delivery channel94 can have a laterally-locatedchannel entry port96 laterally outside of the sacral ala90 and/oriliac bone2. Thetransosseous delivery channel94 can have achannel exit port98 adjacent to the L5-S1 intervertebral disc space. For example, thechannel exit port98 can be in the51 endplate. Thechannel exit port98 can be positioned so the circumference of thechannel exit port98 tangentially coincides with or is closely adjacent to (e.g., within about 2 cm, more narrowly within about 1 cm, more narrowly within about 5 mm, yet more narrowly within about 2 mm) with the edge of the51vertebral endplate100.
• The L5-S1 intervertebral space can be partially or completely void of soft tissue, as shown, for example from a discectomy performed before insertion of thesupport device14. 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 Aug. 2011, which is incorporated by reference herein in its entirety.
• FIG. 25 illustrates that thesupport device14 can be inserted, as shown byarrow102, medially through thechannel entry port96 of thetransosseous delivery channel94. Thedevice14 can be removably and/or articulatably attached to adeployment tool shaft104.
• FIG. 26 illustrates that theshaft104 can be further translated, as shown byarrow106, into thetransosseous delivery channel94. Thesupport device14 can translate toward and into the L5-S1 intervertebral disc space. The distal tip of thesupport device14 can enter the L5-S1 intervertebral disc. Thesupport device14 can enter the target site of the L5-S1 intervertebral disc directly from thetransosseous delivery channel94 without passing through any soft tissue between the L5-S1 intervertebral disc and theiliac bone2.
• FIG. 27 illustrates that theshaft104 can be further translated, as shown byarrow108, medially through thetransosseous delivery channel94. Thedevice14 can translate, as shown byarrow110, through the L5-S1 intervertebral disc space and the L5 and/or the S1 vertebra. Thesupport device14 can articulate, as shown byarrow112. One or more of thehinges24 can rotate, articulating the segments22. The hinges24 can be controllably rotatably locked and unlocked, for example, by controls on the handle of the deployment tool (of which theshaft104 is a part).
• Thesupport device14 can then be further translated, such as being pushed and/or vibrated (e.g., manually, ultrasonically), for example, medially and laterally, and/or superior and inferiorly, and/or anteriorly and posteriorly. The through ports and/or cavities and/or recesses50 in thedevice14 can be partially and/or completely filled bone morphogenic protein, therapeutic agents, other materials listed herein or combinations thereof. Thesupport device14 can deliver a cauterizing electrical energy from the deployment tool. Thesupport device14 andshaft104 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-S1 intervertebral disc space).
• FIG. 28 illustrates that before, during or after thesupport device14 is positioned in the L5-S1 intervertebral space, theshaft104 can detach from thesupport device14 and be translated laterally, as shown byarrow114, from the L5-S1 intervertebral disc space and thetransosseous delivery channel94. Thedeployment tool shaft104 can remove or reposition thesupport device14, or leave thesupport device14 in place in the L5-S1 space.
• The method shown inFIGS. 25 through 28 can be repeated to delivermultiple support devices14 to one or more intervertebral spaces. For example, one, two, three ormore support devices14 can be positioned in the L4-L5 intervertebral space and/or the L5-S1 intervertebral space. The one, two, three ormore support devices14 positioned in the L4-L5 and/or L5-S1 intervertebral spaces, can mechanically support the adjacent vertebrae and/or fix the adjacent vertebrae to each other. Bone ingrowth can occur through the through ports50, for example fusing thesupport devices14 to the respective surrounding vertebrae.
• FIGS. 29 through 31 illustrate that thetransosseous delivery channel94 can have acoronal delivery angle120 measured to thecoronal plane122, asagittal delivery angle124 measured to thesagittal plane126, and atransverse delivery angle128 measured to thetransverse plane130. Thecoronal delivery angle120 can be from about 0° to about 25°, for example about 12°. Thesagittal delivery angle124 can be from about 65° to about 90°, for example about 75°. Thetransverse delivery angle128 can be from about 0° to about 20°, for example about 10°. Thesupport device14 andshaft104 can be configured so thesupport device14 can exit the channel exit port98 (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 L5-S1 intervertebral space.
• FIGS. 30 and 31 show one or bothfemurs132 for illustrative purposes.
• FIGS. 32athrough32d,and separatelyFIGS. 33athrough 33cillustrate the deployment of thesupport device14 into the L5-S1 intervertebral disc space target site, as described forFIGS. 24-27. Thesupport device14 can be delivered to a complete or partialdiscectomy target site138 in the L5-S1 space.
• FIG. 33dillustrates theshaft104 can be rotated, as shown byarrow134, about the longitudinal axis of the shaft before during or after thesupport device14 is positioned in the L5-S1 intervertebral disc space target site. Thesupport device14 can rotate, as shown byarrow136, in the L5-S1 intervertebral disc space, for example to control and position thesupport device14 to an angular orientation in thetransverse plane130.
• 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 above-described configurations, elements or complete assemblies and methods and their elements for carrying out the invention, and variations of aspects of the invention can be combined and modified with each other in any combination.

Claims (3)

We claim:

1. 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-vertebral bone and a vertebra, wherein the creating of a channel through the vertebra comprises creating a channel through a vertebral end plate, and wherein creating the channel comprises drilling with a flexible drill, and wherein the non-vertebral bone comprises the pelvis; and

inserting the support device through the channel and into the target site, wherein inserting the support device through the channel and into the target site comprises:

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 support device with respect to the first rigid section, wherein the first rigid section is hingedly attached to the second rigid section; and

inserting the second rigid section of the support device into the target site.

2. The method ofclaim 1, wherein the non-vertebral bone comprises the ilium.

3. The method ofclaim 1, wherein the non-vertebral bone comprises the sacrum.

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