Growth modulation system

This application is a continuation of U.S. application Ser. No. 12/560,199, filed Sep. 15, 2009, the contents of which are hereby incorporated by reference in their entirety.

Various systems have been utilized to treat spinal deformities such as scoliosis, spondylolisthesis, and others. Primary surgical methods for treatment utilize instrumentation to correct a spinal deformity and implantable hardware systems to rigidly stabilize and maintain the correction. Many of these implantable hardware systems rigidly fix the spinal column to help facilitate fusion after the column has been moved to a corrected position. In some cases, the hardware systems are intended to allow growth or other movement of the corrected spinal column.

Some aspects of embodiments described herein relate to a spinal management system including a stabilizing member adapted to extend substantially longitudinally along a target region of a spine tending to exhibit a defective curvature and a set of stabilizing anchors adapted for fixation to vertebrae and to receive the stabilizing member to secure the stabilizing member against substantial transverse translation relative to the vertebrae. The system also includes a first correction anchor adapted for fixation to a vertebra, a second correction anchor adapted for fixation to a vertebra, and a connection between the stabilizing member and the first correction anchor and between the first and second correction anchors adapted such that when the connection is tensioned a compressive force is selectively exerted between the first and second correction anchors.

This summary is not meant to be limiting in nature. While multiple embodiments are disclosed herein, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.

FIG. 1 shows an exemplary system for treating a spinal defect, according to some embodiments.

FIG. 2 is a transverse view of the system of FIG. 1 with some features not shown for ease of description.

FIG. 3 is a front view of a correction anchor and connectors of the system of FIG. 1 .

FIG. 4 is a perspective view of another correction anchor of the system of FIG. 1 .

FIG. 5 is a side view of a tensioner and stabilizing member of the system of FIG. 1 .

FIG. 6 is a side view of the tensioner of FIG. 5 with a housing portion removed.

FIG. 7 is a diagrammatical view showing a second system for treating a spinal defect, according to some embodiments.

FIG. 8 is a diagrammatical view showing a third system for treating a spinal defect, according to some embodiments.

FIG. 9 is a diagrammatical view showing a fourth system for treating a spinal defect, according to some embodiments.

FIG. 10 is a diagrammatical view showing a fifth system for treating a spinal defect, according to some embodiments.

Various embodiments have been shown by way of example in the drawings and are described in detail below. As stated above, the intention, however, is not to limit the invention by providing such examples.

Some embodiments relate to a system for correcting spinal deformities, as well as associated methods and devices. In general terms, the system provides for selectively controlling growth of the spine by selectively applying compressive forces to the spine. In some applications, compressive forces are combined with lateral translational corrective force(s) and/or derotational corrective force(s) on a spinal column for halting or reversing defect progression. For example, growth modulation is used in some embodiments to help prevent further defect progression (e.g., further scoliotic degradation such as vertebral body wedging), as well as reverse the effects and/or root causes of abnormal growth under a defective model (e.g., uneven growth across the vertebra). In other words, whether skewed growth is viewed as a result of the spinal deformity and/or a contributing factor to spinal deformity, the system is adapted to modulate growth in order to better treat spinal deformity and encourage a more natural configuration of the spine. In some embodiments, vertebrae are selectively compressed along a first side 24 B of the spinal column 24 , for example along a convex aspect, or convex side of a defective curvature where the vertebrae have become inappropriately thickened. In some embodiments, such selective compression along the first side 24 B helps slow growth along the first side 24 B to facilitate better overall proportionality over time.

Various planes and associated directions are referenced in the following description, including a sagittal plane defined by two axes, one drawn between a head (superior) and tail (inferior) of the body and one drawn between a back (posterior) and front (anterior) of the body; a coronal plane defined by two axes, one drawn between a center (medial) to side (lateral) of the body and one drawn between a head (superior) and tail (inferior) of the body; and a transverse plane defined by two axes, one drawn between a back and front of the body and one drawn between a center and side of the body.

Also, the terms pitch, roll, and yaw are used, where roll generally refers to angulation, or rotation, in a first plane through which a longitudinal axis of a body orthogonally passes (e.g., rotation about a longitudinal axis corresponding to the spinal column), pitch refers to angulation, or rotation, in a second plane orthogonal to the first plane, and yaw refers to angulation, or rotation, in a third plane orthogonal to the first and second planes. In some embodiments, pitch is angulation in the sagittal plane, yaw is angulation in the coronal plane, and roll is angulation in the transverse plane. In various embodiments, changes in pitch, yaw, and/or roll occur concurrently or separately as desired. Moreover, as used herein, “lateral translation” is not limited to translation in the medial-lateral (or lateral-medial) direction unless specified as such.

FIG. 1 is a perspective view of a system 10 for correcting a spinal deformity, according to some embodiments. The system 10 includes a stabilizing member 12 ; a plurality of stabilizing anchors 14 , including a first stabilizing anchor 14 A and a second stabilizing anchor 14 B; a plurality of correction anchors 18 including a first correction anchor 18 A and a second correction anchor 18 B; a plurality of tensioners 20 including a first tensioner 20 A and a second tensioner 20 B; and a plurality of connectors 22 including a first connector 22 A, a second connector 22 B, and a third connector 22 C. As shown, the system 10 is secured to a spinal column 24 formed of a plurality of vertebrae 26 , including a first vertebra 26 A, a second vertebra 26 B, a third vertebra 26 C, a fourth vertebra 26 D, and a fifth vertebra 26 E. The spinal column 24 also has a longitudinal axis Y that generally corresponds to the spinal cord and axis of transverse rotation of the spinal column 24 .

Although the system 10 is shown in FIG. 1 with two stabilizing anchors 14 , three correction anchors 18 , two tensioners 20 , and two connectors 22 , more or fewer are implemented as appropriate in other embodiments. For example, in some embodiments a pair of stabilizing anchors 14 supports the stabilizing member 12 with a single correction anchor 18 and is secured to a vertebra 26 at an apex of a spinal deformation or other location, with a corresponding connector 22 and tensioner 20 coupled to the stabilizing member 12 .

As shown in FIG. 1 , however, the first and second correction anchors 18 A, 18 B are fixed to a target region 24 A of the spinal column 24 tending to exhibit an abnormal, or defective curvature (e.g., scoliosis) in need of correction. The system 10 is optionally used to incrementally control growth of the spinal column 24 in the target region 24 A and to adjust and/or maintain the spinal column 24 at a more natural curvature.

In some embodiments, a single adjustment is made to the system 10 to make a correction to a desired curvature, with the system 10 controlling spinal growth through incremental or gross adjustments as desired. In still other embodiments, the target region 24 A of the spinal column 24 is adjusted to a more natural curvature using other, non-implanted hardware, prior to or in conjunction with implanting and securing the system 10 to the spinal column 24 .

FIG. 1 shows the stabilizing member 12 having a bend according to some embodiments, although the stabilizing member 12 is substantially straight in other embodiments. In FIG. 1 , the bend in the stabilizing member 12 is generally shown for illustrative purposes, where the stabilizing member 12 is optionally bent in one or more of the sagittal and coronal planes. The stabilizing member 12 is optionally formed of a variety of materials, including titanium alloy, cobalt chromium alloy, stainless steel or suitable polymeric materials. In other embodiments, the stabilizing member 12 is formed of superelastic material(s), such as a shape memory material.

In some embodiments, the stabilizing member 12 is substantially elongate and rigid, defining a substantially round cross-section with a mean diameter of about 6 mm and being formed of a suitable biocompatible material, such as titanium alloy ASTM F136. If desired, the stabilizing member 12 incorporates some flex, or springiness while substantially retaining its shape. The cross-sectional shape of the stabilizing member 12 , including various portions thereof, is not limited to circular cross-sections and varies lengthwise in cross-section as desired. The stabilizing member 12 is adapted, or otherwise structured, to extend along the spinal column 24 at a desired spacing from the spinal column 24 .

The stabilizing member 12 has a longitudinal axis X, as well as a first section 30 , a second section 32 , and an intermediate section 34 between the first and second sections 30 , 32 . Where the stabilizing member 12 is substantially straight, the longitudinal axis X is substantially straight. Where the stabilizing member 12 is substantially curved or angled, the longitudinal axis X is similarly curved or angled. The sections 30 , 32 , 34 of the stabilizing member 12 are optionally continuously formed or are formed as separate, connected parts as desired.

Additional examples of stabilizing members in accordance with some embodiments of the system 10 are set forth in U.S. application Ser. No. 11/196,952, filed on Aug. 3, 2005 and entitled DEVICE AND METHOD FOR CORRECTING A SPINAL DEFORMITY, as well as Ser. No. 12/134,058, filed on Jun. 5, 2008 and entitled MEDICAL DEVICE AND METHOD TO CORRECT DEFORMITY, the entire contents of both of which are hereby incorporated by reference.

FIG. 1 shows the pair of stabilizing anchors 14 A, 14 B which are adapted, or otherwise structured, to be mounted, or fixed to one or more vertebrae, such as the first and second vertebrae 26 A, 26 B. The first and second stabilizing anchors 14 A, 14 B are further adapted to receive, and include means for receiving, the stabilizing member 12 such that the stabilizing member 12 is secured laterally, against lateral translation relative to the first and second stabilizing anchors 14 A, 14 B.

Additional examples of stabilizing anchors in accordance with some embodiments of the system 10 are also described in U.S. patent application Ser. No. 12/411,562, entitled “Semi-Constrained Anchoring System”, and filed Mar. 26, 2009, the entire contents of which are incorporated herein by reference.

The stabilizing anchors 14 are adapted to be secured to multiple locations, or points, or a single location, or point. In some embodiments, each of the stabilizing anchors 14 is secured to one or more support vertebrae, such as the first vertebra 26 A and an additional vertebra 26 above or below the first vertebra (e.g., being secured to the pedicles of the L3-L4 vertebrae). In other embodiments, the first stabilizing anchor 14 A is secured to a single support vertebra, such as the first vertebra 26 A (e.g., laterally across the first vertebra 26 A at the pedicles, or at a single point—such as a single pedicle—on the first vertebra 26 A).

The stabilizing anchors 14 are adapted to receive the stabilizing member 12 and secure the stabilizing member 12 against substantial lateral or transverse translation relative to the support vertebrae to which they are attached, (e.g., the first and second vertebrae 26 A, 26 B). In this matter, the vertebrae 26 A, 26 B (as well as any secondary support vertebra to which the first stabilizing anchor 14 A is secured) stabilize the system 10 , providing a line of reference from which to adjust the curvature of the spinal column 24 .

In some embodiments, the stabilizing member 12 is substantially prevented from translating in a direction that is substantially perpendicular to the longitudinal axis X of the stabilizing member 12 at each of the stabilizing anchors 14 A, 14 B. If desired, stabilizing member 12 is able to slide axially, or translate axially, along the longitudinal axis X, relative to the first and/or second stabilizing anchors 14 A, 14 B, and is free to change in at least one of pitch, yaw, and roll at each of the first and second stabilizing anchors 14 A, 14 B.

FIG. 2 shows the system 10 from a transverse plane view, with portions of the spinal column 24 and system 10 not shown for illustrative purposes. For reference, the stabilizing member 12 , the first correction anchor 18 A, the first tensioner 20 A, and the first connector 22 A and the third connector 22 C are shown along with the first vertebra 26 A and third vertebra 26 C.

As shown in FIG. 2 , in some embodiments, the stabilizing member 12 is secured to the spinal column 24 at a pre-selected offset from a longitudinal axis of the spinal column 24 . For example, the stabilizing member 12 is optionally secured at an offset along a medial-lateral axis ML, or right-left axis, and anterior-posterior axis AP, or back-front axis from the spinal column 24 . In some embodiments, the stabilizing member 12 is secured on a left side of the spinal column 24 , e.g., a side where the spinal column 24 tends to exhibit a defective, concave curvature, or aspect of a scoliotic spine. The offset is optionally selected such that corrective force(s) exerted by the system 10 result in a relative lateral translation (e.g., central or medial movement) and/or derotational shift (e.g., clockwise rotation from the bottom view of FIG. 2 ) of selected vertebrae 26 of the spinal column 24 (relative anterior-posterior movement of selected vertebrae 26 can also be accomplished) such that the spinal column 24 exhibits a more natural position. In some embodiments, the system 10 is adapted to exhibit reactive force balancing upon application of corrective forces, for example as set forth in U.S. application Ser. No. 12/485,796, filed on Jun. 16, 2009, and entitled DEFORMITY ALIGNMENT SYSTEM WITH REACTIVE FORCE BALANCING, the entire contents of which is incorporated herein by reference.

FIG. 3 shows the first correction anchor 18 A, also described as an anchor arm, which is adapted to be fixed, and provides means for fixation, to a third vertebra 26 C ( FIG. 1 ). As previously described, the first correction anchor 18 A is fixed to a target region 24 A of the spinal column 24 ( FIG. 1 ) having an abnormal curvature in need of correction.

The first and second correction anchors 18 A, 18 B are optionally substantially similar, and thus various features of both the first and second correction anchors 18 A, 18 B are described in association with the first correction anchor 18 A. Features of the first correction anchor 18 A are designated with reference numbers followed by an “A” and similar features of the second correction anchor 18 B are designated with similar reference numbers followed by a “B.”

The first correction anchor 18 A includes an arm 50 A and a head 52 A and is generally L-shaped upon assembly of the arm 50 A and head 52 A. In some embodiments, the arm 50 A extends from the head 52 A to a terminal coupler 54 A and is disposed generally perpendicular to the head 52 A. In some embodiments, the arm 50 A includes a bend and/or extends at an angle from the head 52 A. The arm 50 A is optionally secured about, and rotatable relative to the head 52 A and is adapted to extend across a vertebra, for example, from one side of the spinal column 24 to an opposite side of the spinal column 24 . In some embodiments, the first correction anchor 18 A is secured to the third vertebra 26 C ( FIG. 1 ) such that the arm 50 A extends across the third vertebra 26 C either adjacent to the spinous processes or through a hole or hollowed portion in the spinous processes (not shown) of the third vertebra 26 C. The first correction anchor 50 A optionally includes means for securing the first correction anchor 50 A to a second vertebral body location on the spinal column 24 (e.g., an aperture in the arm 50 A for receiving a bone screw that is, in turn, secured to same vertebra or a different vertebra than the head 52 A).

As shown in FIG. 3 , the first connector 22 A forms a connection between the stabilizing member 12 and the first correction anchor 18 A, the first connector 22 A being secured to the first correction anchor 18 A, and in particular, through the terminal coupler 54 A of the arm 50 A, although a variety of manners and locations securing the first connector 22 A to the first correction anchor 18 A are contemplated.

In some embodiments, the head 52 A of the correction anchor 18 A is adapted, or is otherwise structured, to be fixed to a portion of the third vertebra 26 C, such as a pedicle of the third vertebra 26 C. The head 52 A includes a body portion 56 A and a cap portion 58 A. The head 52 A optionally includes and/or is adapted to work in conjunction with any of a variety of structures capable of engaging the third vertebra 26 C. For example, the body portion 56 A is optionally configured as a pedicle screw. In some embodiments the cap portion 58 A includes one or more channels 60 A for receiving one of the connectors 22 , such as the third connector 22 C. In some embodiments, the channel 60 A is sized to slidably receive two or more of the connectors 22 .

Assembly of the first correction anchor 18 A includes receiving the arm 50 A on the body portion 56 A of the head 52 A and screwing or otherwise securing the cap portion 58 A onto the body portion 56 A. In some embodiments, the first correction anchor 18 A is substantially rigid.

FIG. 4 shows the third correction anchor 18 C, also described as a guide anchor, the third correction anchor 18 C being of a different design than the first and second correction anchors 18 A, 18 B. The third correction anchor 18 C is adapted to be mounted to one or more vertebrae, such as the fifth vertebra 26 E ( FIG. 1 ), and to receive one or more of the connectors 22 ( FIG. 1 ) such as the third connector 22 C. The third correction anchor 18 C is optionally formed of biocompatible metallic materials, such as titanium, stainless steel, and/or biocompatible polymeric materials, such as PEEK and/or composite materials.

The third correction anchor 18 C includes a mounting portion 60 and a receptacle portion 62 . The mounting portion 60 is adapted to secure the third correction anchor 18 C to one or more vertebrae, taking the form of a pedicle screw in some embodiments. The receptacle portion 62 is generally ring-shaped and forms a passage 64 through which one or more of the connectors 22 is able to pass.

The first tensioner 20 A is shown in FIG. 1 , where the first tensioner 20 A is substantially similar to the second tensioner 20 B in some embodiments. Generally, the first tensioner 20 A provides means for securing the first connector 22 A to the stabilizing member 12 . In some embodiments, the first tensioner 20 A, also described as an adjustment mechanism or coupler, is further adapted to adjust, and provides means for adjusting the effective length of the first connector 22 A.

FIGS. 5 and 6 show the second tensioner 20 B, where FIG. 6 shows the second tensioner 20 B with a portion removed to illustrate inner features thereof. In some embodiments, the second tensioner 20 B provides means for securing the second and third connectors 22 B, 22 C to the stabilizing member 12 . In some embodiments, the second tensioner 20 B is further adapted to adjust, and provides means for adjusting length(s) of the second and/or third connectors 22 B, 22 C.

The first and second tensioners 20 A, 20 B are optionally substantially similar. Thus, various features of both the first and second tensioners 20 A, 20 B are described in association with the second tensioner 20 B. Features of the first tensioner 20 A are designated with reference numbers followed by an “A” and similar features of the second tensioner 20 B are designated with the same reference numbers followed by a “B.”

In some embodiments, the second tensioner 20 B includes a reel 70 B, a circumferential gear 72 B surrounding the reel 70 B, a vertical gear 74 B in contact with the circumferential gear 72 B, an actuation head 76 B, and a housing 78 B.

The reel 70 B, as well as the circumferential gear 72 B and vertical gear 74 B are maintained at least partially within the housing 78 B. In turn, the housing 78 B is adapted to be secured to the stabilizing member 12 . For example, the housing 78 B optionally forms a central lumen through which the stabilizing member 12 is receivable. Upon inserting the stabilizing member 12 through the central lumen, the housing 78 B is adapted to be clamped onto the stabilizing member 12 .

In some embodiments, the housing 78 B incorporates a clamshell design (e.g., a first portion adjustably secured to a second portion) adapted to be tightened onto the stabilizing member 12 (e.g., using one or more fasteners). Thus, in some embodiments, the second tensioner 20 B is substantially fixed with respect to the stabilizing member 12 . In other embodiments, however, the second tensioner 20 B is movable with respect to the stabilizing member 12 , for example being able to rotate about the stabilizing member 12 .

The second and third connectors 22 B, 22 C are attached or secured to the reel 70 B and pass out of the housing 78 B through an appropriately sized opening in the housing 78 B. Actuation of the vertical gear 74 B via the actuation head 76 B turns the circumferential gear 72 B, which turns the reel 70 B, thus winding (or unwinding, depending on the direction in which the reel 70 B is turned) the second and third connectors 22 B, 22 C about the reel 70 B. Rotation of the reel 70 B in the appropriate direction draws the second connector 22 B in toward the second tensioner 20 B, pulling the second correction anchor 18 B ( FIG. 1 ) toward the second tensioner 20 B according to some methods of correcting a spinal defect.

Upon turning of the reel 70 B, the third connector 22 C is also drawn in toward the second tensioner 20 B, which compresses select portions of the spinal column 24 as described subsequently in greater detail. In other embodiments, the third connector 22 C is secured to a different one of the plurality of tensioners 22 such that the effective lengths of the second and third connectors 22 A, 22 C are able to be independently adjusted. In still other embodiments, the second tensioner 20 B is adapted to independently actuate the second and third connectors 22 B, 22 C, the tensioner 20 B including multiple reel diameters and/or actuation components, for example, such that the second and third connectors 22 B, 22 C spool at different rates and/or spool independently. In still other embodiments, one or more portions of the second and third connectors 22 B, 22 C are secured together, for example being crimped or welded to a common connector (not shown), such that the second tensioner 20 B simultaneously actuates the second and third connectors 22 B, 22 C by spooling the common connector.

From the foregoing, it should also be understood that the first connector 22 A and the first tensioner 20 A are similarly coupled, where actuation of the first tensioner 20 A modifies an effective length of the first connector 22 A, either drawing the first connector 22 A toward the first tensioner 20 A or letting out the first connector 22 A away from the first tensioner 20 A.

The connectors 22 A, 22 B, 22 C are optionally substantially similar, and thus various features of the first, second, and third connectors 22 A, 22 B, 22 C are described in association with the first connector 22 A. Features of the first connector 22 A are designated with reference numbers followed by an “A” and similar features of the second and third connectors 22 B, 22 C are designated with similar reference numbers followed by a “B” or a “C,” respectively.

In some embodiments, the first connector 22 A is substantially flexible such that the first connector 22 A is able to be pivoted in multiple directions and/or be spooled or wound, for example. Suitable flexible materials for forming the first connector 22 A include wire and stranded cables, monofilament polymer materials, multifilament polymer materials, multifilament carbon or ceramic fibers, and others. In some embodiments, the first connector 22 A is formed of stainless steel, titanium alloy, or cobalt chromium wire or cable, although a variety of materials are contemplated.

As shown in FIG. 1 , the first connector 22 A, also described as a force directing member or a cable, is adapted to be secured to the first correction anchor 18 A and the first tensioner 20 A, the first connector 22 A defining an effective length between the first tensioner 20 A and the first correction anchor 18 A, and thus the stabilizing member 12 (although, in some embodiments, the first connector 22 A is secured directly to the stabilizing member 12 ). The first connector 22 A has a body 80 A and extends from a first end to a second end. In some embodiments, the body 80 A is a single, substantially monolithic component (e.g., a single, continuous piece of cable). In other embodiments, the body 80 A is formed of multiple components (e.g., both flexible and rigid components) secured together to form connections with various components of the system 10 . As described, in some embodiments, the first tensioner 20 A is adapted to modify, and provides means for modifying, the effective length of the first connector 22 A.

As shown in FIG. 3 , the third connector 22 C also has a body 80 C extending from a first end to a second end 84 C. At the second end 84 C, the third connector further includes an end piece 88 C, such as a grommet, for securing the third connector 22 C to the first correction anchor 18 A.

In view of the foregoing, a manner of assembling the system 10 is described with reference to FIG. 1 . The first and second tensioners 20 A, 20 B are secured to the stabilizing member 12 . The first and second stabilizing anchors 14 A, 14 B are secured to the first and second vertebrae 26 A, 26 B, respectively. In some embodiments, the first and second vertebrae 26 A, 26 B are generally located posteriorly and anteriorly, proximate the upper and lower ends, of the target region 24 A tending to exhibit defective curvature. In some embodiments, one or both of the first and second vertebrae 26 A, 26 B exhibit defective positioning (e.g., forming a part of the defective curvature of the target region 24 A). In some embodiments, one or both of the first and second vertebrae 26 A, 26 B have a substantially natural orientation (e.g., being located substantially outside the area(s) of the spinal column 24 exhibiting defective curvature).

The stabilizing member 12 is received in the first and second stabilizing anchors 14 A, 14 B to secure the stabilizing member 12 against lateral translation relative to the spinal column 24 . The first and second correction anchors 18 A, 18 B are secured to the third and fourth vertebrae 26 C, 26 D and the third correction anchor 18 C is secured to the fifth vertebra 26 E. As previously described, features of the first and second stabilizing anchors 14 A, 14 B are selected to limit pitch, yaw, roll, and axial sliding of the stabilizing member 12 as desired.

Assembly of the system 10 includes securing the first and second connectors 22 A, 22 B to the first and second correction anchors 18 A, 18 B, respectively. The first and second connectors 22 A, 22 B are also secured to the first and second tensioners 20 A, 20 B, respectively, such that the connectors 22 A, 22 B form connections between the stabilizing member 12 and the correction anchors 18 A, 18 B.

The first connector 22 A is assembled to the first correction anchor 18 A by securing the second end of the first connector 22 A to the first correction anchor 18 A proximate the terminal coupler 54 A thereof. In some embodiments, the first connector 22 A is secured at the terminal coupler 54 A of the first correction anchor 18 A, and extends along at least a portion of the arm 50 A to the head 52 A, although the first connector 22 A is attached at any location along the arm 50 A and/or the head 52 A of the first correction anchor 18 A as appropriate. The first connector 22 A is securable to the first correction anchor 18 A via a variety of methods, including welding, adhesives, tying, screw fixation, and/or other coupling means, for example.

The second connector 22 B and the second correction anchor 18 B are optionally secured or connected together using similar approaches.

The third connector 22 C is passed through the head 52 A of the first correction anchor 18 A, through the receptacle portion 62 of the third correction anchor 18 C, through the head 52 B of the second correction anchor 18 B, and to the second tensioner 20 B to form a connection between the stabilizing member 12 and the third correction anchor 18 C, as well as between the second and third correction anchors 18 B, 18 C. In some embodiments, the second end 84 C of the third connector 22 C is fitted with the end piece 88 C, for example by clamping the end piece 88 C onto the second end 84 C, such that the second end 84 C is unable to slide back through the head 52 A of the first correction anchor 18 A such that a tension on the third connector 22 C directs the first correction anchor 18 A toward the second correction anchor 18 B.

In some embodiments, the first connector 22 A extends to and is maintained by the first tensioner 20 A, the first connector 22 A being wound about its reel (not shown), thereby coupling the first tensioner 20 A to the first correction anchor 18 A as well as the stabilizing member 12 . In some embodiments, the first connector 22 A is secured to the reel via welding, screw fixation, adhesives, swaging, and/or other coupling means and/or is sufficiently wound about the reel for frictional retention of the first connector 22 A on the reel.

The second and third connectors 22 B, 22 C and the second tensioner 20 B are optionally secured or connected together using similar approaches. As previously mentioned, the third connector 22 C is optionally secured to a third tensioner (not shown) or the second tensioner 20 B includes means for independent adjustment of the connectors 22 B, 22 C as desired. For example, as shown in FIG. 1 , the third connector 22 C is connected from the stabilizing member 12 to the first correction anchor 18 A through the second and third correction anchors 18 B, 18 C.

Upon assembly of the system 10 , the first and second tensioners 20 A, 20 B are adjusted as desired to tension the respective connections and pull the first and second correction anchors 18 A, 18 B toward the first and second tensioners 20 A, 20 B, and thus the stabilizing member 12 thereby exerting a derotational and/or lateral translational force on the target region 24 A. By adjusting the second tensioner 20 B, the effective length of the third connector 22 C can also be shortened in order to apply a compressive force between the third and fourth vertebrae 26 C, 26 D along the third connector 22 C, where the third correction anchor 18 C acts as a guide to help ensure that the third connector 22 C is maintained at a desired path along the spinal column 24 .

In some embodiments, the compressive force is generally directed along a side of the spinal column 24 opposite the stabilizing member 12 . For example, as shown in FIG. 1 , the compressive force is directed along the first side 24 B of the spinal column 24 (in this case, the convex aspect of the target region 24 A) where the stabilizing member 12 is generally situated on the opposite side of the spinal column 24 (in this case, the concave aspect of the target region 24 A). In other words, according to some embodiments, the third connector 22 C extends at a lateral offset in the medial-lateral direction from the longitudinal axis Y such that the second connector is offset toward the first side 24 B of the spinal column 24 which corresponds to a defective, lateral convex curvature of the spinal column 24 .

Various other embodiments are treated with reference to FIGS. 7-10 , which are schematic drawings of second through fifth systems 200 , 300 , 400 , 500 , respectively. As described in greater detail, the systems 200 , 300 , 400 , 500 are shown in association with spinal columns having vertebrae exhibiting uneven growth.

The second system 200 shown in FIG. 7 optionally includes various components similar to those previously described. In some embodiments, the system 200 includes a stabilizing member 212 ; a plurality of stabilizing anchors 214 including a first stabilizing anchor 214 A and a second stabilizing anchor 214 B; a plurality of correction anchors 218 including a first correction anchor 218 A, a second correction anchor 218 B, and a third correction anchor 218 C; a plurality of tensioners 220 including a first tensioner 220 A and a second tensioner 220 B; and a plurality of connectors 222 including a first connector 222 A and a second connector 222 B.

As shown, the system 200 is secured to a spinal column 224 formed of a plurality of vertebrae 226 , including a first vertebra 226 A, a second vertebra 226 B, a third vertebra 226 C, and a fourth vertebra 226 D, the spinal column 224 having a target region 224 A tending to exhibit defective curvature.

In some embodiments, the first correction anchor 218 A is substantially similar to the correction anchor 18 A of the system 10 while the second and third correction anchors 218 B, 218 C are both substantially similar to the third correction anchor 18 C of the system 10 . The stabilizing member 212 , stabilizing anchors 214 , tensioners 220 , and connectors 222 are optionally substantially similar to the stabilizing member 12 , stabilizing anchors 14 , tensioners 20 and connectors 22 of the system 10 .

As shown in FIG. 7 , in some embodiments the first and second stabilizing anchors 214 A, 214 B are secured to support vertebrae, such as the first and second vertebrae 226 A, 226 B, respectively, which reside on opposing ends of the target region 224 A. The stabilizing member 212 is received by the stabilizing anchors 212 to provide stabilizing points from which to exert corrective forces on the target region 224 A of the spinal column 224 . The first and second tensioners 220 A, 220 B are mounted to the stabilizing member 212 and the first correction anchor 218 is secured to the third vertebra 226 C with the first connector 222 A forming a connection between the first correction anchor 218 A and the first tensioner 220 A in a manner similar to that previously described (e.g., through a terminal coupler 254 A of the first correction anchor 218 A). The second and third correction anchors 218 B, 218 C are secured to the fourth vertebra 226 D, the second correction anchor 218 B being on the convex side of the spinal column 224 and the third correction anchor 218 C being opposite the second correction anchor 218 B on the concave side of the spinal column 224 .

The second connector 222 B is secured to the second tensioner 220 A, extending from the second tensioner 220 A through a receptacle portion 262 B of the second correction anchor 218 B, a receptacle portion 262 C of the second correction anchor 218 C, and a head 252 A of the first correction anchor 218 A, the second end 284 B of the second connector 222 B having an end piece 288 B for substantially preventing the second connector 222 B from being drawn back through the head 252 A of the first correction anchor 218 A. As shown, the second connector 222 B forms a connection between the stabilizing member 12 and the first correction anchor 218 A, as well as between the correction anchors 218 A, 218 B, 218 C, respectively, and extends along one side of the spinal column 24 between the first and third correction anchors 218 A, 218 C, for example being laterally offset in the medial-lateral direction from the longitudinal axis Y. In some embodiments, the second connector is offset toward the side of the spinal column 24 corresponding to a defective, lateral convex curvature of the spinal column 24 .

In some embodiments, adjustment of the first tensioner 220 A to shorten an effective length of the first connector 222 A results in a derotational and/or translational force on the target region 224 A and more specifically the third vertebra 226 C. In turn, adjustment of the second tensioner 220 B to shorten an effective length of the second connector 222 B tensions the connection between the stabilizing member 12 and the first correction anchor 218 A, resulting in a compressive force between the third and first correction anchors 218 C, 218 A, and thus between the third and fourth vertebrae 226 C, 226 D. In some embodiments, shortening of the effective length of the second connector 222 B also results in a derotational and/or translational force on the defect region 224 A, and more specifically the fourth vertebra 226 D, as the second connector 222 B is pulled against and engages the second and/or third correction anchors 218 B, 218 C.

The compressive force between the third and fourth vertebrae 226 C, 226 D is optionally used to manage or modulate growth of the spinal column 224 between those vertebrae. In particular, the vertebrae 226 in the target region 224 A are shown to have grown unevenly, being taller in height at the convex side of the spinal column 224 compared to the concave side of the spinal column 224 . Such uneven growth often corresponds to a defective curvature associated with scoliosis, for example. In particular, the vertebrae 226 become less dense and taller on the convex side of the defective curvature. By selectively compressing the vertebrae 226 along the convex side where the vertebrae 226 have become inappropriately thickened, it is contemplated that the vertebrae 226 in the defective region 224 A will begin to exhibit more normal proportions. In particular, the side under compression should slow vertebral body growth, while helping decompress the concave side, thus helping increase growth on the concave side, allowing better proportionality in the vertebral segment(s).

The third system 300 shown in FIG. 8 optionally includes various components similar to those previously described. In some embodiments, the system 300 includes a stabilizing member 312 ; a plurality of stabilizing anchors 314 including a first stabilizing anchor 314 A and a second stabilizing anchor 314 B; a plurality of correction anchors 318 including a first correction anchor 318 A, a second correction anchor 318 B, and a third correction anchor 318 C; a plurality of tensioners 320 including a first tensioner 320 A, a second tensioner 320 B, and a third tensioner 320 C; and a plurality of connectors 322 including a first connector 322 A, a second connector 322 B, a third connector 322 C, and a fourth connector 322 D.

As shown, the system 300 is secured to a spinal column 324 formed of a plurality of vertebrae 326 , including a first vertebra 326 A, a second vertebra 326 B, a third vertebra 326 C, a fourth vertebra 326 D, a fifth vertebra 326 E, a sixth vertebra 326 F, and a seventh vertebra 326 G, the spinal column 324 having a target region 324 A tending to exhibit defective curvature.

In some embodiments, the first, second, and third correction anchors 318 A, 318 B, 318 C are substantially similar to the correction anchor 18 A of the system 10 . The stabilizing member 312 , stabilizing anchors 314 , tensioners 320 , and connectors 322 are optionally substantially similar to the stabilizing member 12 , stabilizing anchors 14 , tensioners 20 and connectors 22 of the system 10 .

The stabilizing anchors 314 and stabilizing member 312 are secured to the spinal column 324 similarly to embodiments previously described. In some embodiments, the first and third tensioners 320 A, 320 C are mounted to the stabilizing member 312 and connected to the first and third correction anchors 318 A, 318 C and using the first and fourth connectors 322 A, 322 D. The tensioners 320 A, 320 C are used as desired to tension respective connections between the stabilizing member 312 and the correction anchors 318 A, 318 C by modifying effective lengths of the first and fourth connectors 322 A, 322 D to apply translational and/or derotational forces to the target region 324 A as desired, and, in particular, the third and fifth vertebrae 326 C, 326 E.

The second tensioner 320 B is also mounted to the stabilizing member intermediate the first and third tensioners 320 A, 320 C. The second tensioner 320 B maintains the second and third connectors 322 B, 322 C and is adapted to modify effective lengths of the second and third connectors 322 B, 322 C.

In some embodiments, the second connector 322 B is passed through a terminal coupler 354 B of the second correction anchors 318 B and through a head 352 B of the second correction anchor 318 B. The second connector 322 B extends from the head 352 B through a head 352 A of the first correction member 318 C. A second end 384 B of the second connector 322 B includes an endpiece 388 B, which helps prevent the second end 384 B from being pulled back through the head 352 A of the first correction anchor 318 A.

The third connector 322 C is similarly passed through the second correction anchor 318 B to the third correction anchor 318 C, with a second end 384 C of the third connector 322 C being similarly secured relative to the third correction anchor 318 C.

As previously noted, the second tensioner 320 B is adapted to modify the effective lengths of the second and third connectors 322 B, 322 C. In some embodiments, the second and third connectors 322 B, 322 C are wrapped onto a common spool (not shown) of the second tensioner 320 B such that they are concurrently spooled upon actuation of the second tensioner 322 B. In other embodiments, the second tensioner 320 B is configured for independent actuation of the second and third connectors 322 B, 322 C (e.g., using multiple spools) and/or different actuation rates of the second and third connectors 322 B, 322 C (e.g., using different diameter spools). In still other embodiments, the second and third connectors 322 B, 322 C are secured to a common tether (not shown) that is spooled into the second tensioner 320 B.

Upon reducing the effective lengths of the second and third connectors 322 B, 322 C, compressive forces are directed from each of the third and fifth vertebrae 326 C, 326 E toward the fourth vertebra 326 D along the second and third connectors 322 B, 322 C, respectively.

Similarly to the first and second systems 10 , 200 , the compressive forces between the third and fourth vertebrae 326 C, 326 D and the fifth and fourth vertebrae 326 E, 326 D are optionally used to manage or modulate growth of the spinal column 324 between those vertebrae 326 , such as to modify or correct uneven growth associated with defective spinal curvature.

The fourth system 400 shown in FIG. 9 optionally includes various components similar to those previously described. In some embodiments, the system 400 includes a stabilizing member 412 ; a plurality of stabilizing anchors 414 including a first stabilizing anchor 414 A and a second stabilizing anchor 414 B; a plurality of correction anchors 418 including a first correction anchor 418 A, a second correction anchor 418 B, a third correction anchor 418 C, a fourth correction anchor 418 D, and a fifth correction anchor 418 E; a plurality of tensioners 420 including a first tensioner 420 A, a second tensioner 420 B, and a third tensioner 420 C; and a plurality of connectors 422 including a first connector 422 A, a second connector 422 B, a third connector 422 C, a fourth connector 322 D, and a fifth connector 422 E.

As shown, the system 400 is secured to a spinal column 424 formed of a plurality of vertebrae 426 , including a first vertebra 426 A, a second vertebra 426 B, a third vertebra 426 C, a fourth vertebra 426 D, a fifth vertebra 426 E, a sixth vertebra 426 F, and a seventh vertebra 426 G, the spinal column 424 having a target region 424 A tending to exhibit defective curvature.

In some embodiments, the first, third, and fifth correction anchors 418 A, 418 C, 418 E are substantially similar to the correction anchor 18 A of the system 10 , while the second and fourth correction anchors 418 B, 418 D are substantially similar to the third correction anchor 18 C of the system 10 . The stabilizing member 412 , stabilizing anchors 414 , tensioners 420 , and connectors 422 are optionally substantially similar to the stabilizing member 12 , stabilizing anchors 14 , tensioners 20 and connectors 22 of the system 10 .

The stabilizing anchors 414 and stabilizing member 412 are secured to the spinal column 424 similarly to embodiments previously described. In some embodiments, the first, second, and third tensioners 420 A, 420 B, 420 C are mounted to the stabilizing member 412 form connections to the first, third, and fifth correction anchors 418 A, 418 C, 418 E using the first, third, and fifth connectors 422 A, 422 C, 422 E. The tensioners 420 A, 420 B, 420 C are used as desired to modify effective lengths of the first, third, and fifth connectors 422 A, 422 C, 422 E to apply translational and/or derotational forces to the target region 424 A, and in particular the third, fifth, and seventh vertebrae 426 C, 426 E, 426 G via the first, third, and fifth correction anchors 418 A, 418 C, 418 E.

The first and third tensioners 420 A, 420 C also maintain the second and fourth connectors 422 B, 422 D and are adapted to modify effective lengths of the second and fourth connectors 422 B, 422 D, respectively. As referenced in association with other embodiments, the first and third tensioners 420 A, 420 C are adapted for independent or concurrent spooling of multiple connectors 422 as desired.

In some embodiments, the second connector 422 B is passed through a head 452 C of the third correction anchor 418 C, through a receptacle portion 462 D of the fourth correction anchor 418 D, and through a head 452 E of the fifth correction anchor 418 E.

The fourth connector 422 D is similarly passed through or around the head 452 C of the third correction anchor 418 C, through a receptacle portion 462 B of the second correction anchor 418 B, and through a head 452 A of the first correction anchor 418 A. Second ends 484 B, 484 D of each of the second and fourth connectors 422 B, 422 D include endpieces 488 B, 488 D, which help prevent the second ends 484 B, 484 D from being pulled back through the heads 452 A, 452 E of the first and fifth correction anchors 418 A, 418 E, respectively.

Upon actuation of the first and third tensioners 420 A, 420 C to shorten the effective lengths of the second and fourth connectors 422 B, 422 D, compressive forces are directed from each of the third and seventh vertebrae 426 C, 426 G toward the fifth vertebra 426 E along the second and fourth connectors 422 B, 422 D, respectively.

Similarly to the first, second, and third systems 10 , 200 , 300 , the compressive forces are optionally used to manage or modulate growth of the spinal column 424 between those vertebrae 426 , such as to modify or correct uneven growth associated with defective spinal curvature.

The fifth system 500 shown in FIG. 10 optionally includes various components similar to those previously described. In some embodiments, the system 500 includes a stabilizing member 512 ; a plurality of stabilizing anchors 514 including a first stabilizing anchor 514 A and a second stabilizing anchor 514 B; a plurality of correction anchors 518 including a first correction anchor 518 A, a second correction anchor 518 B, a third correction anchor 518 C, a fourth correction anchor 518 D, and a fifth correction anchor 518 E; a plurality of tensioners 520 including a first tensioner 520 A, a second tensioner 520 B, and a third tensioner 520 C; and a plurality of connectors 522 including a first connector 522 A, a second connector 522 B, and a third connector 522 C.

As shown, the system 500 is secured to a spinal column 524 formed of a plurality of vertebrae 526 , including a first vertebra 526 A, a second vertebra 526 B, a third vertebra 526 C, a fourth vertebra 526 D, a fifth vertebra 526 E, a sixth vertebra 526 F, and a seventh vertebra 526 G, the spinal column 524 having a target region 524 A tending to exhibit defective curvature.

In some embodiments, the first, third, and fifth correction anchors 518 A, 518 C, 518 E are substantially similar to the correction anchor 18 A of the system 10 , while the second and fourth correction anchors 518 B, 518 D are substantially similar to the third correction anchor 18 C of the system 10 . The stabilizing member 512 , stabilizing anchors 514 , tensioners 520 , and connectors 522 are optionally substantially similar to the stabilizing member 12 , stabilizing anchors 14 , tensioners 20 and connectors 22 of the system 10 .

The stabilizing anchors 514 and stabilizing member 512 are secured to the spinal column 524 similarly to embodiments previously described. In some embodiments, the first, second, and third tensioners 520 A, 520 B, 520 C are mounted to the stabilizing member 512 and form connections with the first, third, and fifth correction anchors 518 A, 518 C, 518 E using the first, second, and third connectors 522 A, 522 B, 522 C. The tensioners 520 A, 520 B, 520 C are used as desired to modify effective lengths of the first, second, and third connectors 522 A, 522 C, 522 E to apply translational and/or derotational forces to the target region 524 A, and in particular the third, fifth, and seventh vertebrae 526 C, 526 E, 526 G via the first, third, and fifth correction anchors 518 A, 518 C, 518 E.

The first tensioner 520 A and first connector 522 A also apply a compressive force to the spinal column 524 . In particular, the first connector 522 A extends through a terminal coupler 554 A to the head 552 A of the first correction anchor 518 A and is then directed superiorly by the head 552 A through a receptacle 562 B of the second correction anchor 518 B, a head 552 C of the third correction anchor 518 C, a receptacle 562 E of the fourth correction anchor 518 E, and through a head 552 E of the fifth correction anchor 518 E. A second end 584 A of the first connector 522 A includes an endpiece 588 A to help prevent the second end 584 A from pulling back through the fifth correction anchor 518 E. Upon tensioning the first connector 522 A, the target region 524 A is compressed along the first connector 522 A. In particular, the third through seventh vertebrae 526 C- 526 G are placed in compression. Moreover, the first connector 522 A tightens against the head 552 A of the first correction anchor 518 A, such that a translational and/or derotational force is applied at the terminal coupler 554 A of the first correction anchor 518 A.

Similarly to the first, second, third, and fourth systems 10 , 200 , 300 , 400 the compressive force is optionally used to manage or modulate growth of the spinal column 524 between those vertebrae 526 , such as to modify or correct uneven growth associated with defective spinal curvature.

The various systems and methods provided according to the foregoing detailed description include features that are interchangeable as appropriate. In view of the foregoing, systems, methods, and devices according to some embodiments provide for exerting a gross corrective force (translational and/or rotational) on a spinal column in combination with exerting a compressive force selectively applied along a side of the spinal column, for example a side generally opposite a direction of correction. Some embodiments relate to translating application of a corrective force on a spinal column (translation and/or derotation) to an axial force to selectively limit vertebral growth. Various other features and advantages are contemplated.

For example, various modifications and additions can be made to the exemplary embodiments discussed without departing from the scope of the present invention. While the embodiments described above refer to particular features, the scope of this invention also includes embodiments having different combinations of features and embodiments that do not include all of the described features. Accordingly, the scope of the present invention is intended to embrace all such alternatives, modifications, and variations as fall within the scope of the claims, together with all equivalents thereof.