Apparatus for spinal fixation and methods of use

In some embodiments, a method comprises forming a lumen in a first bone portion and forming a lumen in a second bone portion. The method further includes inserting a portion of a flexible fastening band through the lumen in the first bone portion and through the lumen in the second bone portion, and inserting the portion of the flexible fastening band into a fastener mechanism monolithically formed with the flexible fastening band. The method further includes advancing the portion of the flexible fastening band through the fastener mechanism until the first bone portion and the second bone portion are stabilized.

CROSS-REFERENCE AND RELATED APPLICATIONS

This application is related to U.S. patent application Ser. No. 29/448,946 entitled “Flexible Elongate Member with a Portion to Receive a Bone Anchor,” filed on even date herewith.

BACKGROUND

Some embodiments described herein relate generally to methods and apparatus for stabilizing bone, for example, stabilizing vertebrae by securing the articular processes of the vertebrae.

Traumatic, inflammatory, and degenerative disorders of the spine can lead to severe pain and loss of mobility. One source of back and spine pain is related to degeneration of the facets of the spine or facet arthritis. Bony contact or grinding of degenerated facet joint surfaces can play a role in some pain syndromes. While many technological advances have focused on the intervertebral disc and artificial replacement or repair of the intervertebral disc, relatively little advancement in facet repair has been made. Facet joint and disc degeneration frequently occur together.

The current standard of care to address the degenerative problems with the facet joints is to fuse the two adjacent vertebrae. By performing this surgical procedure, the relative motion between the two adjacent vertebrae is stopped, thus stopping motion of the facets and any potential pain generated as a result thereof. Procedures to fuse two adjacent vertebrae often involve fixation and/or stabilization of the two adjacent vertebrae until the two adjacent vertebrae fuse.

Injuries and/or surgical procedure on and/or effecting other bones can also result in the desire to fixate and/or stabilize a bone until the bone, or bone portions, can fuse, for example, to stabilize a sternum after heart surgery, to stabilize a rib after a break, etc. Current procedures to fixate and/or stabilize adjacent vertebrae and/or other bones, however, can be slow and/or complex.

Accordingly, a need exists for an apparatus and methods to better stabilize and/or fixate a bone.

SUMMARY

In some embodiments, a method comprises forming a lumen in a first bone portion and forming a lumen in a second bone portion. The method further includes inserting a portion of a flexible fastening band through the lumen in the first bone portion and through the lumen in the second bone portion, and inserting the portion of the flexible fastening band into a fastener mechanism monolithically formed with the flexible fastening band. The method further includes advancing the portion of the flexible fastening band through the fastener mechanism until the first bone portion and the second bone portion are stabilized.

DETAILED DESCRIPTION

In some embodiments, a method comprises forming a lumen in a first bone portion and forming a lumen in a second bone portion. The method further includes inserting a portion of a flexible fastening band through the lumen in the first bone portion and through the lumen in the second bone portion, and inserting the portion of the flexible fastening band into a fastener mechanism monolithically formed with the flexible fastening band. The method further includes advancing the portion of the flexible fastening band through the fastener mechanism until the first bone portion and the second bone portion are stabilized.

In some embodiments, an apparatus includes a flexible elongate body and an anchor. The flexible elongate body includes a distal end portion, a body portion, and an attachment connection. The attachment connection receives the distal end portion of the flexible elongate body when the body portion is disposed in contact with a first bone portion and a second bone portion. The anchor receives a fastener configured to secure the flexible elongate body to the first bone portion via the anchor.

In some embodiments, a kit includes a flexible band and a fastener. The flexible band includes an interface portion configured to receive the fastener. The flexible band is configured to stabilize a first bone portion and a second bone portion. The fastener is configured to anchor the flexible band to the first bone portion such that the first bone portion, the second bone portion, and the flexible band are stabilized after being anchored.

As used in this specification, the singular forms “a,” “an” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, the term “a ratchet” is intended to mean a single ratchet or a combination of ratchets. As used in this specification, a substance can include any biologic and/or chemical substance, including, but not limited to, medicine, adhesives, etc. While exemplary references are made with respect to vertebra, in some embodiments another bone can be involved. While specific reference may be made to a specific vertebra, a subset of vertebrae, and/or a grouping of vertebrae, it is understood that any vertebra, subset, and/or grouping, or combination of vertebrae can be used.

The words “proximal” and “distal” generally refer to the direction closer to and away from, respectively, a center of a body. The embodiments described herein, however, can be arranged in any orientation relative to the center of the body. Thus, when discussing the embodiments described herein (specifically a flexible elongate body), the terms “proximal” and “distal” refer to a direction closer to and away from, respectively, an attachment connection or fastener mechanism, the position of which is visually presented with respect to specific embodiments in the attached figures.

As shown inFIG. 1, the vertebral column2includes a series of alternating vertebrae4and fibrous discs6that provide axial support and movement to the upper portions of the body. The vertebral column2typically comprises thirty-three vertebrae4, with seven cervical (C1-C7), twelve thoracic (T1-T12), five lumbar (L1-15), five fused sacral (S1-S5) and four fused coccygeal vertebrae.FIGS. 2A and 2Bdepict a typical thoracic vertebra. Each vertebra includes an anterior body8with a posterior arch10. The posterior arch10includes two pedicles12and two laminae14. The two laminae14join posteriorly to form a spinous process16. Projecting from each side of the posterior arch10is a transverse process18, a superior process20, and an inferior articular process22. The facets24,26of the superior processes20and the inferior articular processes22form facet joints28with the articular processes of the adjacent vertebrae (seeFIGS. 3A and 3B). The facet joints are synovial joints with cartilaginous surfaces and a joint capsule.

The orientation of the facet joints vary, depending on the level of the vertebral column. In the C1 and C2 vertebrae, for example the facet joints are parallel to the transverse plane.FIGS. 4A to 6Bdepict examples of the orientations of the facet joints at different levels of the vertebral column. In the C3 to C7 vertebrae examples shown inFIGS. 4A and 4B, the facets are oriented at a 45-degree angle to the transverse plane30and parallel to the frontal plane32, respectively. This orientation allows the facet joints of the cervical vertebrae to flex, extend, lateral flex and rotate. At a 45-degree angle in the transverse plane30, the facet joints of the cervical spine can guide, but do not limit, the movement of the cervical vertebrae.FIGS. 5A and 5Bdepict examples of the thoracic vertebrae, where the facets are oriented at a 60-degree angle to the transverse plane30and a 20-degree angle to the frontal plane32, respectively. This orientation is capable of providing lateral flexion and rotation, but only limited flexion and extension.FIGS. 6A and 6Billustrate examples of the lumbar region, where the facet joints are oriented at 90-degree angles to the transverse plane30and a 45-degree angle to the frontal plane32, respectively. The lumbar vertebrae are capable of flexion, extension and lateral flexion, but little, if any, rotation because of the 90-degree orientation of the facet joints in the transverse plane. The actual range of motion along the vertebral column can vary considerably with each individual vertebra.

In addition to guiding movement of the vertebrae, the facet joints also contribute to the load-bearing ability of the vertebral column. One study by King et al. Mechanism of Spinal Injury Due to Caudocephalad Acceleration, Orthop. Clin. North Am., 6:19 1975, found facet joint load-bearing as high as 30% in some positions of the vertebral column. The facet joints may also play a role in resisting shear stresses between the vertebrae. Over time, these forces acting on the facet joints can cause degeneration and arthritis.

In some embodiments described herein, a flexible elongate body can be anchored to a first vertebra via an anchor and can be used to stabilize and/or fixate a first vertebra to a second vertebra to reduce the pain, to reduce further degradation of a spine (e.g., a specific vertebra and/or a specific disc of a spine), and/or until the first vertebra and the second vertebra have fused.FIG. 7is a schematic block diagram of a flexible elongate body140(also referred to herein as “flexible band” or simply “band”) and an anchor180, according to an embodiment. The band140includes at least a body portion145, a distal end portion148, and an attachment connection150(alternatively referred to herein as “fastener mechanism”). The band140can be formed from any suitable biocompatible material such as, for example, stainless steel, titanium, polyether ether ketone (PEEK), nylon, or the like. Moreover, the band140can be any suitable shape, size, or configuration. In some embodiments, the size or shape of the band140can be associated with an intended usage. For example, in some embodiments, a first band can be intended to stabilize and/or fixate one or more cervical vertebra and a second band can be intended to stabilize and/or fixate one or more lumbar vertebra. In this manner, the first band can have a first size that is substantially smaller than a second size of the second band. In other embodiments, the size and shape need not be associated with an intended usage.

The fastener mechanism150is configured to accept at least a portion of distal end portion148and/or the body portion145, as further described herein. The fastener mechanism150is disposed at a proximal end of the band140. In some embodiments, the fastener mechanism150defines a lumen (not shown inFIG. 7) configured to accept at least a portion of distal end portion148and/or the body portion145. In some embodiments, the lumen of fastener mechanism150can have a cross-sectional area that is significantly smaller than a cross-sectional area of at least a portion of the body portion145. In this manner, the portion of the body portion145can be prevented from advancing through fastener mechanism150. In some embodiments, the fastener mechanism150can include a ratchet (not shown inFIG. 7) configured to engage a surface of the distal end portion148and/or the body portion145. In this manner, the fastener mechanism150can be configured to allow the distal end portion148and/or the body portion145to advance through fastener mechanism150in a first direction and substantially limit the movement of the distal end portion148and/or the body portion145in a second direction, opposite the first direction.

The body portion145is a linear elongate that extends from a portion of the fastener mechanism150. More specifically, the body portion145of the band140can be monolithically formed with the fastener mechanism150such that the body portion145is a linear elongate portion between the fastener mechanism150and the distal end portion148. In other embodiments, the body portion145can be coupled to the fastener mechanism150in any suitable manner (e.g., coupled via an adhesive, a weld, a friction fit, a threaded fit, or the like). The body portion145can be any suitable configuration. For example, in some embodiments, the body portion145can have a cross-sectional shape that is polygonal (e.g., square, rectangular, trapezoidal, etc.) or oval (e.g., circular, elliptical, oblong, etc.). In some embodiments, the cross-sectional shape of the body portion145can be associated with one or more characteristics of the bone or bone portion against which the body portion145may contact. For example, while the body portion145can have a substantially square cross-sectional shape, a set of edges of the body portion145can be rounded, partially rounded, and/or otherwise shaped to compliment the shape of a bone or bone portion, and/or to reduce digging or grinding into the bone or bone portion. In this manner, use of band140may cause little or no damage to the bone or bone portions contacted by band140.

In some embodiments, the body portion145can define a substantially uniform cross-sectional area along a longitudinal axis (e.g., a centerline) of the band140. In other embodiments, the cross-sectional area of the body portion145can vary along the longitudinal axis (centerline) of the band140. For example, in some embodiments, the body portion145can have a cross-sectional area that is substantially tapered (i.e., reduced) from a proximal end (e.g., adjacent the fastener mechanism150) to a distal end (e.g., adjacent the distal end portion148). In some embodiments, the cross-sectional area of the body portion145can be associated with the cross-sectional area of the lumen defined by the fastener mechanism150(the attachment connection150described above). In this manner, at least a portion of the body portion145can have a cross-sectional area that is sufficiently small such that the body portion145can be at least partially disposed within the lumen of the fastener mechanism150.

The body portion145can be configured to include a gear rack (not shown inFIG. 7) configured to engage the ratchet (not shown inFIG. 7) of the fastener mechanism150. As described above, the gear rack can be configured to engage the ratchet of the fastening member150such that the ratchet allows the body portion145to travel through the fastener mechanism150in the first direction and substantially limits the movement of the body portion in the second direction, opposite the first direction. In some embodiments, the gear rack can be configured to include a set of individual gears that extend from a surface of the body portion145. In other embodiments, the body portion145can define the set of individual gears (e.g., the gears each include a top surface that is disposed at or below a surface of the body portion145). The gears included in the set of gears can be any suitable shape, size, or configuration. For example, in some embodiments, the gears are substantially cubed. In other embodiments, the gears can be triangular such that the gears form, for example, teeth. In this manner, the gears included in the gear rack can be configured to engage the ratchet of the fastener mechanism150, as described above.

The distal end portion148is configured to extend from the body portion145of the band140. More specifically, the distal end portion148is disposed adjacent the distal end of the body portion145such that the body portion145is disposed between the distal end portion148and the fastener portion150. In some embodiments, the distal end portion148can have a cross-sectional area that is substantially similar to the cross-sectional area of the body portion145. In other embodiments, the distal end portion148can have a cross-sectional area that is substantially smaller than the cross-sectional area of the body portion145. In such embodiments, the distal end portion148and the body portion145can collectively define a discontinuity defining a stepwise reduction in the cross-sectional area. In other embodiments, the body portion145and/or the distal end portion148can define a tapered portion such that the band140is tapered between smaller cross-sectional area of the distal end portion148and the larger cross-sectional area of the body portion145.

While not shown inFIG. 7, in some embodiments, the distal end portion148can include a gear rack that is substantially similar to the gear rack of the body portion145. In this manner, the gear rack can extend substantially continuously across a portion of the distal end portion148and a portion of the body portion145. In other embodiments, the distal end portion148of the band140need not include or define a gear rack.

The anchor180is configured to receive a fastener185to secure the band140to a bone portion. In some embodiments, the anchor180is monolithically formed with the band140. For example, in some embodiments, the anchor180can be disposed on or within the body portion145and can define an aperture (not shown inFIG. 7) configured to receive the fastener185(e.g., a mechanical fastener such as a screw, bolt, staple, nail, etc.). In other embodiments, the anchor180is a protrusion extending from the body portion145in a substantially perpendicular direction (e.g., relative to the longitudinal axis of the band140). In other embodiments, the anchor180can be a protrusion that extends in an angular direction from the body portion145or the distal end portion148(e.g., non-perpendicular to the body portion145or the distal end portion148). In some embodiments, the anchor180can be a portion of the band140including a surface configured to receive the fastener185. For example, in such embodiments, the anchor180can have a surface configured to receive a biocompatible adhesive or tape.

In some embodiments, the anchor180can be formed independently from the band140and can be at least partially disposed about the band140to secure the band140to the bone portion. For example, in some embodiments, the anchor180can define a second aperture configured to receive the distal end portion148of the band140. In this manner, the anchor180can define a strap or loop configured to be slid into any suitable position along the distal end portion148and/or the body portion145. In some embodiments, the anchor180can form a hook (e.g., a J-hook, an L-hook, etc.). In this manner, the anchor180can be configured to engage at least three sides of the band140. In such embodiments, the anchor180can include an edge configured to engage a surface of the bone portion to retain the band140between the edge and the fastener185when the fastener185is disposed within the second aperture (e.g., defined by the anchor180) and the bone portion, as described in further detail herein.

In use, the band140can be configured, for example, to stabilize a vertebra (e.g., a first vertebra) and/or a second vertebra by securing an articular process of the first vertebra to an articular process of a second vertebra. More specifically, the band140can be configured to stabilize the first vertebra and/or a second vertebra by securing an articular process of the first vertebra to an articular process of a second vertebra by securing a facet of the articular process of the first vertebra with a facet of the articular process of the second vertebra. For example, the band140can be placed into a suitable position relative to the first vertebra and/or the second vertebra, and the distal end portion148of the band can be inserted into the lumen of the fastener member150such that the body portion145substantially encircles at least a portion of the first vertebra and the second vertebra. Similarly stated, the distal end portion148can be inserted in to the lumen of the fastener mechanism150such that the band140forms a loop about the articular process of the first vertebra and the articular process of the second vertebra. In this manner, the distal end portion148and/or the body portion145can be advanced through the lumen of the fastener mechanism150such that the volume disposed within the loop formed by the band140is reduced. Thus, the band140exerts a compressive force on the articular process of the first vertebra and the articular process of the second process. While not shown inFIG. 7, in some embodiments, a spacer can be disposed between the articular process of the first vertebra and the articular process of the second process such that a desired distance between the articular process of the first vertebra and the articular process of the second process is maintained. In some embodiments, the spacer can include and/or define a portion configured to reduce slippage of the band140along a surface of the first vertebra and/or the second vertebra. Examples of spacers are further defined below with respect to specific embodiments.

With the band140at least partially tightened about the articular process of the first vertebra and the articular process of the second vertebra, the fastener185can be inserted into the anchor180and advanced into a portion of the articular process of the first vertebra and/or second vertebra. In some embodiments, the fastener185can be advanced through a pre-drilled hole of the articular process. In other embodiments, the fastener185can be configured to self-tap into the articular process (e.g., when the fastener is a self taping screw). In this manner, the anchor180can be affixed to the articular process of the first vertebra and/or the second vertebra such that the anchor180secures the band140to the first vertebra and/or the second vertebra. In this manner, the distal end portion148and/or the body portion145can be advanced through the lumen defined by the fastener mechanism150to stabilize and/or fixate the first vertebra to the second vertebra. Furthermore, by affixing the anchor180to the first vertebra and/or the second vertebra, the anchor180can substantially reduce slippage of the band140relative to the first vertebra and/or the second vertebra.

While not explicitly described above, in embodiments wherein the anchor180is independently formed, the anchor180can be disposed about the distal end portion148and/or the body portion145prior to inserting the distal end portion148into the lumen of the fastener member150. While being described above as being partially tightened about the first vertebra and the second vertebra prior to affixing the anchor180, in other embodiments, the anchor can be affixed to the first vertebra and/or the second vertebra prior to inserting the distal end portion148into the fastener mechanism150. Conversely, in some embodiments, the band140can be tightened to a desired amount prior to the anchor180being affixed to the first vertebra and/or the second vertebra.

FIG. 8Ais a side view andFIG. 8Bis a top view of a flexible elongate body240(also referred to herein as “band”) according to an embodiment. The band240can be similar to the band140described above and can include similar components. For example, the band240includes an attachment connection250(also referred to herein as “fastener mechanism”) including a ratchet262, a body portion245including a gear rack247, and a distal end portion248. Accordingly, components of the band240that are similar to corresponding components of the band140described above with reference toFIG. 7are not described in further detail herein.

As shown inFIG. 8A, each gear264included in the gear rack247includes a cross sectional area that is rectangular in shape. Said another way, each gear264can be a rectangular protrusion configured to extend from a surface of the band240(e.g., the body portion and/or the distal end portion248). The gear rack247is configured to engage the ratchet262of the fastener mechanism250, as further described herein. The fastener mechanism250defines a lumen266. The lumen266can be any suitable shape, size, or configuration. For example, as shown inFIG. 8Bthe lumen266can have a substantially circular cross-sectional area. The ratchet262extends from an inner surface of the fastener member250such that the ratchet262substantially reduces the size (e.g., the perimeter, circumference, and/or cross-sectional area) of the lumen266. In this manner, the ratchet266can engage the gear rack247. More specifically, as described in detail with reference toFIG. 7, the distal end portion248can be inserted into the lumen266of the fastener mechanism250and advanced in a first direction such that the gear rack247of the distal end portion248engages the ratchet262. In some embodiments, the distal end portion248can be advanced through the lumen266a sufficient distance such that a portion of the body portion245is disposed within the lumen266. In such embodiments, a portion of the gear rack247disposed on (e.g., included in or defined by) the body portion245can engage the ratchet262. In this manner, the arrangement of the ratchet262and the gear rack247can be such that the distal end portion248can be moved in the first direction, thereby tightening the band240, and the distal end portion248can be prevented from moving in a second direction, opposite the first direction, thereby preventing the band240from loosening.

The band240can be used in any suitable procedure to stabilize and/or fixate a first bone portion to a second bone portion. For example, in some embodiments, the band240can be disposed about an articular process of a first vertebra and an articular process of a second vertebra. In this manner, the distal end portion248and/or the body portion245can be positioned within the lumen266of the fastener mechanism250such that the band240forms a loop of suitable tightness about the first vertebra and the second vertebra. The band240can be used in conjunction with any suitable anchor configured to facilitate the stabilization and/or fixation of the first vertebra to the second vertebra and further configured to reduce potential slippage of the band240relative to the first vertebra and/or the second vertebra (as described in detail above with reference toFIG. 7).

In some embodiments, the band240can be used in any procedure described in or similar to those in U.S. patent application Ser. No. 12/859,009; filed Aug. 18, 2010, and titled “Vertebral Facet Joint Drill and Method of Use” (referred to as “the '009 application”), the disclosure of which is incorporated herein by reference in its entirety. In some embodiments, the band240can be used in conjunction with a spacer such as those described in the '009 application. For example, the spacer can be implanted and deployed to restore the space between facets of a superior articular process of a first vertebra and an inferior articular process of an adjacent vertebra. The spacer can be implanted and deployed to help stabilize adjacent vertebrae with adhesives and/or to deliver a medication. For example, in some embodiments, the spacer can be at least temporarily maintained in a desired position via an adhesive while the band240is positioned relative to the first vertebra and/or second vertebra. In some embodiments, an adhesive can be used in conjunction with the band240to stabilize and/or fixate the first vertebra to the second vertebra.

In some embodiments, the spacer can be, for example, substantially disc shaped. In other embodiments, the spacer can be other shapes, e.g., square, elliptical, or any other shape. The spacer can include a first side and a second side. The first side and/or the second side can be, for example, convex, concave, or flat. Said another way, the first side of the spacer can be concave, convex, or flat, and the second side of the spacer can be concave, convex, or flat, for example, the first side can be concave and the second side concave, the first side can be concave and the second side convex, etc. The spacer can include the same materials as band140. In some embodiments, the spacer can include substances configured to release medication and/or increase the stability of a vertebra and/or band140. As discussed above, the substances can include a medicine(s) and/or an adhesive(s).

FIGS. 9A-10Billustrate a flexible elongate body340(also referred to herein as “band”), an anchor380, and a spacer354collectively used to stabilize adjacent vertebrae according to an embodiment. As shown inFIG. 9A, the band340can be used to stabilize a first vertebra4A and a second vertebra4B via the spinous articular process16A (also referred to herein as “process16A”) of the first vertebra4A and the spinous articular process16B (also referred to herein as “process16B”) of the second vertebra4B. The band340can be similar to band140described above with reference toFIG. 7and can include similar components. By way of example, band340includes a fastener mechanism350(FIG. 9B), a body portion345(FIG. 9B), and a distal end portion348(FIG. 10B). As shown inFIGS. 9A-10B, the band340can be monolithically constructed in an elongate shape and can have a substantially rectangular cross-sectional shape. More specifically, the band340can have a substantially rectangular shape including rounded edges configured to reduce digging or grinding into the bone or portion thereof.

The fastener mechanism350defines a lumen366and includes a ratchet362. The lumen366of the fastener mechanism350receives the distal end portion348of the band340such that the body portion345forms a loop that substantially encircles the process16A of the first vertebra4A and the process16B of the second vertebra4B. While not shown in FIGS.9A-10B, the band340includes a gear rack that can be similar to or the same as the gear racks described above in the previous embodiments. In this manner, the ratchet362is configured to engage the gear rack of the band340to maintain the distal end portion348of the band340within the lumen366(as described in detail above).

The anchor380is configured to substantially surround a portion of the band340as shown inFIGS. 9A and 9B. More specifically, the anchor380can be a hook (e.g., a J-hook or the like) configured to substantially surround the band340on at least three sides (e.g., all of the sides of the band340except the side disposed adjacent the first vertebra4A). The anchor380defines an aperture (not shown inFIGS. 9A-10B) configured to receive a fastener385. In this manner, the fastener385can be advanced into the process16A of the first vertebra4A to affix the anchor380thereto. Moreover, with the anchor380disposed about the portion of the band340, the anchor380can limit the movement of the band340relative to the first vertebra4A and the second vertebra4B (e.g., in the posterior or anterior direction).

The spacer354is disposed between the process16A of the first vertebra4A and the process16B of the second vertebra4B. The spacer354can be any suitable shape, size, or configuration. For example, as shown inFIGS. 10A and 10B, the spacer354can be substantially rectangular and can include a first indentation351, configured to receive a portion of the process16A, and a second indentation352, configured to receive a portion of the process16B. Thus, the first indentation351is disposed opposite the second indentation352and a desired distance is defined therebetween. For example, in some embodiments, the distance between the first indentation351and the second indentation352is associated with a desired distance between the process16A of the first vertebra and the process16B of the second vertebra4B. Expanding further, when the band340is tightened (e.g., the distal end portion348is advanced through the fastener mechanism350), the spacer354can be configured to limit the tightening of the band340such that the desired distance between the process16A and the process16B is retained. In this manner, the spacer354can substantially limit undue pressure on the disc6(FIGS. 9A and 10A), an artificial disk, or a cage disposed between the first vertebra4A and the second vertebra4B, otherwise induced by over tightening the band340.

As shown inFIG. 10B, the spacer354further includes a first side wall356and a second side wall358. The first side wall356and the second side wall358can be configured to each define a channel359(shown on the first side wall356inFIGS. 9A and 9B). The channel359can receive a portion of the band340such that the walls defining the channel359substantially limit a posterior and/or an anterior movement of the portion of the band340(e.g., the walls form a barrier that limit the movement of the band340relative to the spacer354). In this manner, the spacer354can reduce slippage of the band340relative to the process16A and/or process16B that may otherwise occur during tightening of the band340. While the anchor380is shown as being disposed at a posterior position relative to the band340, in other embodiments, the anchor380can be disposed in an anterior configuration wherein the fastener385is disposed on an anterior portion of the process16A relative to the band340.

While the anchor380is shown as being independently formed from the band340, in other embodiments, an anchor can be monolithically formed with a band. For example,FIGS. 11A-11Cillustrate a flexible elongate body440(also referred to herein as “band”) according to an embodiment. The band440can be similar to band140described above with reference toFIG. 7and can include similar components. By way of example, band440includes a fastener mechanism450, a body portion445, a distal end portion448, and an anchor portion480. As shown inFIGS. 11A-11C, the band440can be monolithically constructed in an elongate shape and can have a substantially rectangular cross-sectional shape. More specifically, the band440can have a substantially rectangular shape including rounded edges configured to reduce digging or grinding into the bone or portion thereof. The fastener mechanism450defines a lumen466and includes ratchet462. The body portion445includes a gear rack447having a set of gears464. In this manner, the distal end portion448can be inserted into the lumen466of the fastener member450such that the gear rack447engages the ratchet462, as described in detail above. The anchor portion480is monolithically formed with the band440. More specifically, the anchor portion480can be a substantially annular portion of the band480configured to define an aperture482. The aperture482can receive a fastener485(FIGS. 12A and 12B), as further described herein.

As shown inFIGS. 12A and 12B, the band440can be used to stabilize a first vertebra4A and a second vertebra4B via the spinous articular process16A (also referred to herein as “process16A”) of the first vertebra4A and the spinous articular process16B (also referred to herein as “process16B”) of the second vertebra4B. More specifically, the lumen466of the fastener mechanism450can receive the distal end portion448of the band440such that the body portion445forms a loop that substantially encircles the process16A of the first vertebra4A and the process16B of the second vertebra4B (as described in detail above). The fastener485can be inserted into the aperture482(FIGS. 11A-11C) and advanced into the process16A of the first vertebra4A to affix the anchor portion480thereto. In some embodiments, the fastener485can be inserted into the aperture482and at least partially advanced into the process16A of the first vertebra4A prior to the distal end portion448of the band440being inserted into the lumen466of the fastener mechanism450. In some embodiments, the fastener485can be advanced into the process16A concurrently with the distal end portion448being advanced through the lumen466.

With the anchor portion480affixed to the process16A via the fastener485, movement of the band440in the anterior and/or posterior direction, relative to the process16A is substantially limited. In addition, a spacer454can be disposed between the process16A of the first vertebra4A and the process16B of the second vertebra4B prior to tightening the band440about the process16A of the first vertebra4A and the process16B of the second vertebra4B. For example, in some embodiments, the spacer454can be disposed between the process16A of the first vertebra4A and the process16B of the second vertebra4B after advancing the fastener485into the process16A and prior to advancing the distal end portion448of the band440through the lumen466. In other embodiments, the spacer454can be disposed between the process16A of the first vertebra4A and the process16B of the second vertebra4B prior to the insertion of the fastener454in the process16A and prior to the insertion of the distal end portion448into the lumen466. In still other embodiments, the spacer454can be disposed between the process16A of the first vertebra4A and the process16B of the second vertebra4B after the fastener485is advanced into the process16A and after the band440is partially tightened. The spacer454can be similar to the spacer354described above with reference toFIGS. 9A-10B. Therefore, the form of spacer454is not described in detail herein. As described above, the spacer454can reduce slippage of the band440relative to the process16A and/or process16B that may occur during tightening of the band440.

While the anchor portion480is shown inFIGS. 11A-12Bas being substantially aligned with the body portion445of the band440(e.g., a center point of the annular shaped anchor portion480is positioned on a longitudinal axis or centerline of the band440), in some embodiments, a flexible elongate body can include an anchor portion that is not positioned on a longitudinal axis or centerline. For example,FIGS. 13A-13Cillustrate a flexible elongate body540(also referred to herein as “band”) according to an embodiment. The band540can be similar to band140described above with reference toFIG. 7and can include similar components. By way of example, band540includes a fastener mechanism550, a body portion545, a distal end portion548, and an anchor portion580. As shown inFIGS. 13A-13C, the band540can be monolithically constructed in an elongate shape and can have a substantially rectangular cross-sectional shape. More specifically, the band540can have a substantially rectangular shape including rounded edges configured to reduce digging or grinding into the bone or portion thereof. The fastener mechanism550defines a lumen566and includes ratchet562. The body portion545includes a gear rack547having of a set of gears564. In this manner, the distal end portion548can be inserted into the lumen566of the fastener member550such that the gear rack547engages the ratchet562, as described in detail above.

The anchor portion580is monolithically formed with the band540. More specifically, the anchor portion580can be a lateral protrusion extending from a side of the band540. For example, in some embodiments, the anchor portion580can extend substantially perpendicularly from a side of the band540. In other embodiments, the anchor portion580can extend from the side of the band540at any suitable angular orientation (i.e., an angular orientation other than the perpendicular orientation (e.g., other than 90 degrees)). The anchor portion580can be substantially annular such that the anchor portion580defines an aperture582. The aperture582can receive a fastener585(FIGS. 14A and 14B), as further described herein.

As shown inFIGS. 14A and 14B, the band540can be used to stabilize a first vertebra4A and a second vertebra4B via the spinous articular process16A (also referred to herein as “process16A”) of the first vertebra4A and the spinous articular process16B (also referred to herein as “process16B”) of the second vertebra4B. More specifically, the lumen566of the fastener mechanism550can receive the distal end portion548of the band540such that the body portion545forms a loop that substantially encircles the process16A of the first vertebra4A and the process16B of the second vertebra4B (as described in detail above). The fastener585can be inserted into the aperture582(FIGS. 13A-13C) and advanced into the process16A of the first vertebra4A to affix the anchor portion580thereto.

With the anchor portion580affixed to the process16A via the fastener585, movement of the band540in the anterior and/or posterior direction, relative to the process16A is substantially limited. In addition, a spacer554can be disposed between the process16A of the first vertebra4A and the process16B of the second vertebra4B. The spacer554can be similar to the spacer554described above with reference toFIGS. 9A-10B. Therefore, the form of spacer554is not described in detail herein. As described above, the spacer554can reduce slippage of the band540relative to the process16A and/or process16B that may occur during tightening of the band540.

While the anchor portion580is shown extending from a particular side of the band540inFIGS. 13A-14B, in other embodiments, an anchor portion can extend from either side of a band. Moreover, while the band540is shown inFIGS. 13A-14Bas including a single anchor portion580, in other embodiments, a band can include a first anchor portion extending from a first side of the band and a second anchor portion extending from a second side, opposite the first side, of the band. In such embodiments, the first anchor portion and the second anchor portion can be aligned along a length of a band or the first anchor portion and the second anchor portion can be offset along the length of the band.

FIG. 15illustrates a flexible elongate body640(also referred to herein as “band”), and a spacer654collectively used to stabilize adjacent vertebrae according to an embodiment. While not shown inFIG. 15, flexible elongate body can be used with an anchor, such as, for example, an anchor280, anchor380and/or anchor480, as shown and described above. As shown inFIG. 15, the band640can be used to stabilize a first vertebra4A and a second vertebra4B via the spinous articular process16A (also referred to herein as “process16A”) of the first vertebra4A and the spinous articular process16B (also referred to herein as “process16B”) of the second vertebra4B. The band640can be similar to band140described above with reference toFIG. 7and can include similar components. By way of example, band640includes a fastener mechanism650, a body portion645, and a distal end portion (not shown). UnlikeFIGS. 9A-10B, which depict a spacer having indentations and channels, spacer654can be substantially cylindrical in shape, and can include a first lumen659to receive a portion of band640, and a second lumen659to receive a second portion of band640. Similar to the spacer354, the spacer654is disposed between the process16A of the first vertebra4A and the process16B of the second vertebra4B. The spacer654can be any suitable shape, size, or configuration. In some embodiments, the diameter of the spacer654can be associated with a desired distance between the process16A of the first vertebra and the process16B of the second vertebra4B. Similar to spacer354, when the band640is tightened, the spacer654can be configured to limit the tightening of the band640such that the desired distance between the process16A and the process16B is retained.

Referring now toFIG. 16, a flowchart illustrates a method790for stabilizing a first bone portion and a second bone portion. The method790includes disposing a flexible band into contact with a first bone portion and into contact with a second bone portion, at792. In some embodiments, the flexible band can be, for example, a flexible elongate body such as the flexible elongate body340described above with reference toFIGS. 9A-10B. The flexible band can define an aperture configured to receive a fastener that can secure the flexible band to the first bone. The fastener can be any suitable fastener such as, for example, a mechanical fastener (e.g., a pin, a nail, a screw, a bolt, a staple, or the like), a chemical fastener (e.g., an adhesive, tape, or the like), or any other suitable fastener or combination thereof.

The method790includes advancing a portion of the flexible band through an attachment connection until the first bone portion and the second bone portion are stabilized, at794. The attachment portion can be substantially similar to the attachment portion (e.g., the fastener mechanism)340described herein. The advancing of the portion of the band through the attachment connection can be such that, for example, the band tightens about the first bone portion and about the second bone portion to move the first bone portion from a first orientation relative to the second bone portion to a second orientation relative to the second bone portion. Moreover, the second orientation of the first bone portion relative to the second bone portion can correspond to a stabilized orientation of the first bone portion and the second bone portion. In some embodiments, the first bone portion and the second bone portion can be a portion of a first vertebra and a portion of a second vertebra, respectively. For example, in some embodiments, the first bone portion and the second bone portion can be a spinous articular process of a first vertebra and a spinous articular process of a second vertebra, respectively. In other embodiments, the first bone portion and the second bone portion can be a transverse articular process of a first vertebra and a transverse articular process of a second vertebra, respectively.

In some embodiments, a spacer can be optionally disposed between the first bone portion and the second bone portion to facilitate the stabilization. For example, in some embodiments, the spacer can define a channel configured to receive a portion of the flexible band, thereby limiting or reducing slippage of the flexible band relative to the first bone portion and/or the second bone portion. In some embodiments, a spacer can define a desired distance between the first bone portion and the second bone portion.

The method further includes advancing a portion of the fastener through an aperture and into the first bone portion until the flexible band is secured to the first bone portion, at796. In some embodiments, the fastener can be advanced through a pre-drilled hole in the first bone portion. In other embodiments, the fastener can be a self-taping fastener such as, for example, a self-taping screw. In this manner, the fastener can substantially limit slippage of the flexible band relative to the first bone portion and or the second bone portion.

Any of the embodiments, described above can be packaged independently or in any suitable combination. For example, in some embodiments, a kit can include at least flexible elongate body (e.g., a band) and a fastener. The band can include an interface portion configured to receive the fastener. For example, the band can be similar to or the same as the band440described above with reference toFIGS. 11A-12B. In this manner, the flexible band is configured to stabilize a first bone portion and a second bone portion. The fastener is configured to anchor the flexible band to the first bone portion such that the first bone portion, the second bone portion, and the flexible band are stabilized after being anchored. In some embodiments, the kit can include multiple fasteners of differing kinds. For example, in some embodiments, the kit can include a first fastener that is a bolt and include a second fastener that is a staple. In this manner, the kit can include multiple fasteners configured for use with varying bone structures. By way of example, in some embodiments, the relatively small size of a staple can be suitable for use on a cervical vertebra while the relatively large size of a bolt can be suitable for use on a lumbar vertebra.

In some embodiments, the kit can include a spacer and/or implant. For example, in some embodiments, the kit can include a spacer that is similar to or the same as the spacer354described above with reference toFIGS. 9A-10B. In some embodiments, the kit can include a set of spacers where each spacer has a size different than the other spacers included in the set. For example, in some embodiments, the kit can include (1) a first spacer, having a first size and that is configured to be disposed between a spinous articular process of a first cervical vertebra and a spinous articular process of a second cervical vertebra, and (2) a second spacer having a second size greater than the first size and that is configured to be disposed between a spinous articular process of a first lumbar vertebra and a spinous articular process of a second lumbar vertebra. In this manner, the appropriately sized spacer can be selected to stabilize a first and second vertebra.

While various embodiments have been described above, it should be understood that they have been presented by way of example only, not limitation, and various changes in form and details may be made. For example, while the embodiments are illustrated here as being disposed about a spinous articular process of a first vertebra and a spinous articular process of a second vertebra, in other embodiments, a flexible elongate body (e.g., a band) can be disposed about another portion of one or more vertebra. For example, in some embodiments, a flexible elongate body can be dispose about a transverse articular process of a first vertebra and a transverse articular process of a second vertebra. In such embodiments, the band can be tightened about the vertebrae to offset or correct misalignment of a portion of the spine (e.g., scoliosis, or the like).

While the descriptions given are with reference to stabilizing vertebra, another bone(s) such as for example, a sternum and/or a rib(s) could be stabilized using the flexible fastening bands described herein. In another example, a flexible fastening band can be used to stabilize and/or fixate an intramedullary (IM) rod or nail. For example, the flexible fastening band can be used at different longitudinal locations along an IM rod or nail, and used to couple adjacent bone portions to the IM rod or nail. In such situations, a given flexible fastening band can fix a first bone portion, the IM rod or nail, and a second bone portion, all of which are positioned between the distal portion and the attachment connection of the flexible fastening band. In yet another example, a flexible fastening band can be used to stabilize and/or fixate a bone fragment. While various embodiments have been described above with regard to natural bone spaces, (e.g., the space between an inferior articulate process and a superior articulate process), in other embodiments, the bone spacing can be man-made (e.g., sternum split during a heart procedure), and/or due to an injury (e.g., broken bone).

Where methods described above indicate certain events occurring in certain order, the ordering of certain events can be modified. Additionally, certain of the events can be performed concurrently in a parallel process when possible, as well as performed sequentially as described above. For example, while the method790described above includes advancing a portion of the band into the attachment connection prior to advancing the fastener, in some embodiments, the fastener can be at least partially advanced into a bone portion prior to the portion of the band being advanced through the attachment portion. In some embodiments, at least a portion of the advancing of the fastener into the bone portion and at least a portion of the advancing of the portion of the band into the attachment connection can be done concurrently (e.g., simultaneously or alternatively in relatively small increments).

By way of another example, in some embodiments, a spacer (e.g., the spacer454described above with reference toFIGS. 12A and 12B) can be disposed between a first bone portion and a second bone portion prior to tightening a band (e.g., the band440described above) about the first bone portion and the second bone portion. For example, in some embodiments, the spacer can be disposed between the first bone portion and the second bone portion after advancing a fastener (e.g., the fastener485described above) into the bone portion and prior to inserting a distal end portion of the band into an attachment connection. In other embodiments, the spacer can be disposed between the first bone portion and the second bone portion prior to the insertion of the fastener in the first bone portion and prior to the insertion of the distal end portion into the attachment connection. In still other embodiments, the spacer can be disposed between the first bone portion and the second bone portion after the fastener is completely advanced into the first bone portion and after the band is partially tightened about the first bone portion and the second bone portion.

Any portion of the apparatus and/or methods described herein may be combined in any combination, except mutually exclusive combinations. The embodiments described herein can include various combinations and/or sub-combinations of the functions, components and/or features of the different embodiments described.