CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit under Articles 4 and 8 of the Stockholm Act of the Paris Convention for the Protection of Industrial Property of U.S. Patent Application No. 16/901,193, filed on June 15, 2020, and U.S. Patent Application No. 16/802,695, filed on February 27, 2020, which applications are hereby incorporated by reference herein in their entireties.

FIELD

[0002] The present disclosure relates to spinal alignment, and more particularly to a segmented alignment rod assembly for performing a gradual three-dimensional alignment of a spine which has deviated from a normal attitude for pathologic reasons. The present disclosure also relates to spinal alignment, and more particularly to a method for creating a customized segmented alignment rod assembly for performing a gradual three-dimensional alignment of a spine which has deviated from a normal attitude for pathologic reasons.

BACKGROUND

[0003] Scoliosis is a disorder that causes an abnormal curve of the spine, or backbone.

Patients with scoliosis develop abnormal curves to either side of the body’s median line (lateral curve) and the bones of the spine twist on each other like a corkscrew.

[0004] The Greek physician Hippocrates coined the term scoliosis and devised various forms of external braces and benches to support or stretch the abnormally curved spine. Since animals can also suffer from scoliosis, there is little doubt it is an anomaly that has been around since the dawn of vertebrates. It is estimated that about 3% of humans are afflicted, meaning over 200 million people worldwide are living with this anomaly.

[0005] Females are much more likely to suffer from scoliosis than males and for idiopathic scoliosis the ratio is 10:1. It can be seen at any age, but it is most common in those over ten years old. Present knowledge suggests a genetically predisposed growth asymmetry at the level of the vertebral body endplates as a potential underlying cause. [0006] Minor degrees of scoliosis are treated with bracing or stretching of the spine, not that dissimilar to the prescriptions and descriptions dating back to the time of Hippocrates. While the materials and techniques have changed, the principals have evolved very little.

[0007] Severe degrees of scoliosis are largely treated by a major operation known as segmental instrumented spinal fusion, a lengthy procedure where the muscles are flayed from the spinal bone and metal rods are then implanted to straighten the spine and hold it in position until grafted bone products fuse the spinal vertebrae together into a solid tower of bone. Since the normal spine is segmented to permit functional motion, fusion in and of itself sets the stage for life long corollary problems directly related to the administered cure which precludes normal movement, and at times, even normal growth.

[0008] Because of the magnitude of the surgery, complications include death, paralysis, infection, and hardware failure. Late complications include stiffness, chronic back pain, late hardware failure, and breakdown of adjacent normal segments because of stress provided by the long fused spinal segment. This list of complications is illustrative and not exhaustive.

[0009] Since major scoliosis surgery is such a cataclysmic event, it is often employed as a last resort, meaning that simple curves are followed until major curves develop thereby increasing not only the magnitude of the surgery, but the potential risk of complications as well. [0010] Present scoliosis treatment is rather eclectic, employing everything from techniques of bracing, essentially outlined in the time of Hippocrates, to the major robotic surgeries of present day. As with anything in medicine, whenever multiple solutions exist for a particular disease process, it generally means that no single solution is sufficiently effective. [0011] Figure 1 is a stylized posterior view of a person P with a spine afflicted with scoliosis. Spinal column 1 is shown to have two lateral curves - upper curve 2 and lower curve 3. Often the presence of one lateral curve generates the formation of a second curve to compensate for the reduced spinal support of the body caused by one lateral curve. Figures 2 and 3 depict two different types of prior art braces 4 and 5, respectively, used to prevent further deterioration of spinal alignment. In some cases, braces such as braces 4 and 5 may improve the condition, but they rarely enable the wearer to achieve a full recovery to a correct spinal alignment.

[0012] Clearly, there is a need in the art to have a treatment that is simple and safe enough to employ such that spinal curvatures can be treated early in the pathologic process so that progression to major curvature can be avoided along with the attendant major interventional surgery required when the curves are extreme.

[0013] There is also a need in the art to diminish or eradicate the requirement for fusing the spine such that normal motion can be maintained, and the deleterious consequence of a spinal fusion avoided.

[0014] Other spinal deformities include kyphosis, lordosis, and flatback. Kyphosis, lordosis, and flatback include deformities in the natural curvature of the spine, from a lateral view, or in the sagittal (front to back) plane, whereas scoliosis includes deformities in the straight-line arrangement of the spine, from a posterior view, or in the frontal (side to side) plane. [0015] Kyphosis is an exaggerated, forward rounding of the back, and can occur at any age but is most common in older women. Age-related kyphosis is often due to weakness in the spinal bones that causes them to compress or crack. Other types of kyphosis can appear in infants or teens due to malformation of the spine or wedging of the spinal bones over time.

[0016] Lordosis is defined as an excessive inward curve of the spine. Lordosis is found in all age groups and it primarily affects the lumbar spine, but can occur in the neck (cervical). When found in the lumbar spine, the patient may appear swayback, with the buttocks more prominent, and in general an exaggerated posture. Lumbar lordosis can be painful and sometimes affect movement.

[0017] Flatback syndrome is a condition in which the lower spine loses some of its normal curvature. Normally, the spine has several gentle front-to-back curves. The lumbar (lower) spine has a lordosis, or inward curve. The thoracic (middle) spine has a kyphosis, or outward curve, and the cervical spine (neck) has a lordosis. These curves work in harmony to keep the body’s center of gravity aligned over the hips and pelvis. If the lumbar lordosis is lost, the center of gravity can be put too far forward. This is the case in flatback syndrome.

Clearly, there is a need in the art to have a treatment that is simple and safe enough to employ such that spinal curvatures can be treated early in the pathologic process so that progression to major curvature can be avoided along with the attendant major interventional surgery required when the curves are extreme. There is also a need in the art to diminish or eradicate the requirement for fusing the spine such that normal motion can be maintained, and the deleterious consequence of a spinal fusion avoided. Additionally, there is a need in the art to develop a customized treatment based on the patient’s size, age, sex, and extent of the spinal deformity, such that the treatment is optimized on a patient-by-patient basis.

SUMMARY

[0018] According to aspects illustrated herein, there is provided a segmented rod assembly for aligning a spine including a plurality of vertebrae, comprising a rod, including a plurality of segments, the plurality of segments having at least a first segment arranged to be connected to a first vertebra of the spine, the first segment including a first body and at least one tang extending from the first body, and a second segment arranged to be connected to a second vertebra of the spine, the second segment including a second body and at least one channel arranged in the second body, wherein the at least tang is operatively arranged to engage the at least one channel, and at least one tensioning member arranged within the plurality of segments, the at least one tensioning member having a first end secured to the first segment and a second end.

[0019] According to aspects illustrated herein, there is provided a segmented rod assembly for aligning a spine including a plurality of vertebrae, comprising a rod, including a plurality of segments, the plurality of segments having at least a first segment arranged to be connected to a first vertebra of the spine, a second segment arranged to be connected to a second vertebra of the spine, and a third segment arranged to be connected to a third vertebra of the spine, a first tensioning member arranged at least partially within the first segment and the second segment, and a second tensioning member arranged at least partially within the second segment and the third segment.

[0020] According to aspects illustrated herein, there is provided a segmented rod assembly for aligning a spine including a plurality of vertebrae, comprising a rod, including a plurality of segments, wherein a first segment of the plurality of segments includes a protruding tang, a second segment of the plurality of segments includes an outward facing channel, the protruding tang is operatively arranged to engage the outward facing channel to rigidly connect the first and second segments, and at least one segment of the plurality of segments is connected to a first vertebra of the spine, and at least one tensioning member arranged at least partially within the plurality of segments, wherein the at least one tensioning member is operatively arranged to force the plurality of segments into engagement. [0021] According to aspects illustrated herein, there is provided a segmented rod assembly for aligning a spine having a plurality of vertebrae, comprising a rod, including a plurality of segments, the plurality of segments having at least a first segment arranged to be slidingly secured to a first vertebra of the spine, a second segment arranged to be fixedly secured to a second vertebra of the spine, and a third segment arranged between the first and second segments to be connected to a third vertebra of the spine, a tensioning member arranged within the plurality of segments, the tensioning member having a first end secured to the first segment and a second end.

[0022] According to aspect illustrated herein, there is provided a segmented rod assembly for aligning a spine having a plurality of vertebrae, comprising a first clamp arranged to be secured to a first vertebra of the spine, a second clamp arranged to be secured to a second vertebra of the spine, a third clamp arranged to be secured to a third vertebra of the spine, the third vertebra located between the first vertebra and the second vertebra, a rod, including a plurality of segments, the plurality of segments having at least a first segment slidingly engaged with the first clamp a second segment fixedly secured to the second clamp, and a third segment connected to the third clamp, and a line arranged within the plurality of segments, the line having a first end secured to the first segment and a second end, and a winding mechanism arranged proximate the second segment and connected to the second end.

[0023] A segmented rod assembly for aligning a spine having a plurality of vertebrae, comprising a first clamp arranged to be secured to a first vertebra of the spine, a second clamp arranged to be secured to a second vertebra of the spine, a third clamp arranged to be secured to a third vertebra of the spine, the third vertebra located between the first vertebra and the second vertebra, a rod, including a plurality of segments, the plurality of segments having at least a first segment slidingly engaged with the first clamp, a second segment fixedly secured to the second clamp, and a third segment connected to the third clamp, and a flexible shaft arranged within the plurality of segments, the flexible shaft having a first end secured to the first segment and a second end connected to the second segment, wherein when the flexible shaft is rotated in a first circumferential direction the plurality of segments are drawn toward each other to engage. [0024] The present disclosure broadly comprises an assembly for performing a gradual three-dimensional alignment of a spine which has deviated from a normal attitude for pathologic reasons. The assembly includes a hollow segmented rod, having segments which, when drawn together, form a contoured rod whose reconfigured shape approximates an ideal or non- pathologic spinal configuration. A cable, or cables, is housed within the hollow segments that comprise the rod. In an example embodiment, a flexible shaft assembly is housed within the hollow segments that comprise the rod. The cable, cables, and flexible shaft is designed to draw the hollow segments together such that when the segments are intimately mated, they form a rigid rod that approximates an ideal spinal alignment. The cables or flexible shaft can be drawn taut by a turnbuckle at either or both ends. The cable or tumbuckle/flexible shaft assembly, in turn, are connected to a ratcheting worm drive assembly operated by a mechanically depressible subcutaneous paddle such that gradual spinal alignment can occur as the turnbuckle shortens the intersegmental distance between rod segments and rigid rod alignment is reestablished.

[0025] The present disclosure broadly comprises an assembly for performing gradual lateral alignment of a spine, gradual sagittal alignment of a spine, or a combination of the two, as well as correcting the rotation that invariably accompanies these deviations in severe combinations of the above malalignments. In essence, correction of three-dimensional malalignment.

[0026] The assembly comprises a hollow rod which is pre-contoured to approximate the normal S-shaped configuration of the human spine. The length of the rod and the approximate curves needed to correct the pathologic alignment of a patient is obtained using SURGIMAP® simulation software or similar software that provides computerized renderings of individual patient pathologies known in the art and presently utilized to form custom contoured patient- specific spinal rods for scoliosis surgery. Alternatively, a mathematical average for a specific spine length can be chosen and a statistical ideal curvature for the spine selected.

[0027] Once the ideal patient-specific rod is formed, it is cut into segments, with each segment being roughly the length of a vertebral body segment. In sections where little curvature is anticipated, a rod segment may span two or more vertebral segments. The preformed hollow rod is cut into segments such that each segment can deviate from the other in regard to their original axial alignment, when separated, but bond intimately in a male/female fashion when drawn together by a cable(s) or flexible shaft.

[0028] In an alternative embodiment, the adjacent segments are hinged together at a specific point at or near the circumference of the perimeter of the rod, such that the original curvilinear shape of the rod is approximated once the segments are drawn tautly together by an integrated connecting cable.

[0029] The hollow rod, once segmented, can be passed along the external surface of the spine and assume any of a myriad of pathologic configurations. The segmented rod is then affixed to the spine at the proximal and distal ends, and at the apex of the curvature, should complex rotatory curves be encountered. Individual segments are maintained in close juxtaposition by an interconnecting cable, which permits limited polyaxial movement of the segments. These segments are like beads on a string, render the construct flexible, but stiffen the construct when the string is drawn taut and the beads are pulled into close apposition. By varying the shape of the contact surfaces between the bead elements, different longitudinal shapes can be formed when the string is tautened.

[0030] The fixation of the rod to the spine will be through traditional methods known in the art such as hooks, clamps, screw, or combinations thereof. The preferred embodiment utilized a spinous process clamp which clamps two or more adjacent spinous processes. In an example embodiment, the spinous process clamp clamps only one spinous process. In the case of pedicle screws and the like, expansion screws are preferred and will be described infra.

[0031] Once the segmented rod is drawn subfacially along the pathologic spine and its curves, ideally along the spinous process/lamina junction, and affixed to the spine at two or more strategic locations, the segments are gradually drawn together to assume their original pre segmented attitude, including the built-in contours necessary to restore perfect spinal alignment. By tensioning the cable over time, gradual spinal alignment can be achieved thereby mitigating traction injury to the spinal cord.

[0032] Drawing the segments of the rod together is accomplished in one of two ways. In highly flexible spines where forces are less likely to be extreme, the hinge and cable iteration would be chosen because it would utilize a thinner rod approximating a 5-6 mm diameter. Hinging of the segments would occur along the ventral portion of the rod where sagittal curve correction would be required and laterally where lateral curve correction is anticipated. While a round rod could be used, the hinged version may utilize an oval, or square cross-sectional shape to allow a greater surface area to employ a hinge linkage. In this version, the tautening cable would be located along the perimeter opposite the hinge, insofar as possible, to maximize the mechanical advantage. In stiffer spines, a larger 8-10 mm diameter segmented rod with a single large internal cable capable of withstanding greater force could be employed.

[0033] Once the cable rod is positioned along the spine, the hinged connection allows intimate contact of a particular rod segment with a corresponding vertebral element. The cranial and caudal segments are intimately secured via clamp, hook, or pedicle screw fixation, while the apex segment may be fixated via clamp, hook, pedicle screw, or also a cable to allow better relative movement between the alignment assembly and the spine while restoration of the spine to a normal attitude occurs. The rod segment assembly would be enclosed in a flexible sheath of biocompatible material to prevent tissue ingress or growth between rod segments, e.g., polyethylene. [0034] Tautening of the cables occurs in the caudal segment, which houses a turnbuckle attached to the cable. A subcutaneous ratcheting worm drive mechanism is implanted in, on, or adjacent to the caudal segment and connected to a turnbuckle assembly such that when a subcutaneous paddle is digitally compressed transcutaneously through intact skin, the turnbuckle draws the cable taut thereby pulling the segments together and restoring ideal rod configuration. Since the spine is affixed to the rod, spinal movement mirrors rod movement until rigid configuration of the rod is restored. While one rod should be sufficient to restore alignment, a second rod could be employed to provide greater support of the scoliotic spine during straightening. Certain segments could connect in a ball and socket configuration to allow for limited movement of the spine thereby permitting some normal movement. [0035] In another embodiment, a cable is replaced with a flexible rotary shaft capable of imparting both tensile and rotary forces. This shaft lies in roughly the center of the segments of the rod and is connected to a turnbuckle located at each end. Initially, the caudal turnbuckle is rotated, tensioning the system, and once it reaches maximal tensioning, it begins to rotate the flexible shaft which turns a second turnbuckle located at the cranial end. By employing two tumbuckles, even greater cable shortening and rod tensioning can occur. [0036] To implant the segmented contoured cable rod assembly for gradual spinal alignment, the anesthetized patient is positioned prone on the operating table. After appropriate prepping and draping, fluoroscopy is used to identify the spinal curve apex as well as the cranial and caudal transition to normality. Each position is marked and a small incision is made to expose two spinous processes at each of the three indicated levels. To these exposed spinous processes, a special clamp is affixed serving to attach the segmented cable assembly to the spine. To pass the segmented cable rod assembly from one clamp to the other in subfacial location, a catheter passer is employed. Once the catheter passer is slid subfacially from one incision to another, a cable is slid through the hollow plastic sheath when the malleable trochar is removed. The wire is placed from one incision to the next entering the caudal incision, passing through the apex incision and emanating from the cranial incision. Alternatively, the cable can be passed from the cranial incision to the caudal incision, if desired. The catheter passer is removed leaving the cable behind.

[0037] Once the cable is positioned subfacially in a preferred location, the segmented cable rod assembly is attached to one end of the cable and pulled beneath the fascia along the contours of the spinal curvature. The cable rod assembly is then affixed to the spinous process clamps located at the cranial, caudal, and apex incisions.

[0038] In the preferred embodiment, the segmented cable rod assembly is securely affixed to the caudal clamp so that no relative motion, apart from segment apposition, can occur. To the caudal end of the caudal clamp, a ratcheting tumbuckle assembly is affixed and is used to draw the cable taut when a subcutaneous paddle is depressed.

[0039] In the apex incision, the segmented cable rod is affixed to the clamp such that it can slide relative to the clamp in an axial or longitudinal plane, but is restricted circumferentially by a collar. As the segmented cable rod assembly gradually straightens, it brings the spinous process clamp and spine along with it toward its new attitude. Since the rod can slide unrestricted, and has a sloppy fit, unrestricted spinal growth can occur along with some limited spinal movement. These features buffer the extremes of forces that cause failure in present day fixed scoliosis instrumented constructs, and permits a modicum of normal spinal movement for the child that rigid bracing or fusion deny. [0040] At the superior end, the final segment of the cable rod construct affixes to the cranial clamp via a distal protuberance that engages the clamp in a piston/rod configuration. This association, similar to the collar fixation at the apex, allows for limited lateral/medial and dorsal/ventral movement while permitting linear axial movement as the child grows or whenever the child bends. The length of this slideable component is 5-7 cm to permit normal spinal growth elongation without having to lengthen the rod.

[0041] Once the assembly is affixed to the spine via the clamps the incisions are closed and allowed to heal.

[0042] Gradual spinal alignment is carried out by depressing a subcutaneous paddle beneath the skin at the level of the caudal clamp. This paddle activates a ratcheting worm drive tumbuckle assembly which tautens the cable, thereby drawing the segments of the rod closer together. As the segments approximate gradually, relative motion is restricted until a solid contoured rod assembly is formed, whereupon tightening is ceased. The rigid rod then serves to maintain normal contoured spinal alignment until mature spinal growth has been achieved. At this point, the cable is loosened and the patient is observed to ensure the mature spine does not lapse into misalignment. If it does not, the device assembly is removed, leaving a normal functioning spine. If deviation does occur, the cable assembly is retightened and fusion of the apex is carried out.

[0043] It is clear that the ratcheting worm drive mechanical activator of the present disclosure could be replaced with a magnetic, ultrasonic, or piezoelectric motor if desired. The manually operated activator is preferred in this invention so as to decrease the costs associated with this form of instrumented surgery.

[0044] Should pedicle screws be required or desired as a means of anchoring the assembly to the spine, a pedicle screw with an expansile shaft is preferred. The shaft is expanded once the screw is placed to increase surface area and mitigate “toggling” or “windshield wipering” of the shaft in softer cancellous bone when axial or perpendicular forces are applied to the shaft.

[0045] In some embodiments, the present disclosure uses motors (e.g., servo motors) similar to those used in robotics. For example, motors can be placed at various strategic locations along the segmented rod assembly to tighten various sections of the rod at different times. The motors may be triggered by slackness in its respective tensioning member or cable. Thus, a sensor detecting slackness in a tensioning member would trigger the motor connected thereto to activate and tighten the tensioning member. The motor may turn a threaded screw connected to the tensioning member to tighten the section of the rod.

[0046] In some embodiments, a servo motor may be arranged in each segment (i.e., every two segments is connected by a tensioning member). In some embodiments, the segmented rod assembly is separated into strategic sections according to the normal S-curve of a spine (e.g., based on vertebral height, the extent of the curvature of the deviated portion of the pathologic spine, etc.) and servo motors are assigned to each of those sections. Thus, tensioning members are arranged in series, rather than one long cable biased at the end of the segmented rod, which allows for better control of the corrective spinal alignment process. Springs could also be used instead of or in addition to the motors to bias the tensioning members of the segmented rod assembly.

[0047] The motors may be activated/controlled by sensing slackness in the tensioning members or may be controlled wirelessly via a wireless control and transducers. In some embodiments, muscle wire or bio metal is used for the tensioning members in order to tighten the sections of the segmented rod assembly.

[0048] According to aspects illustrated herein, there is provided a method for creating a segmented alignment rod, the method comprising receiving, by one or more computer processors, a request for a segmented alignment rod, receiving, by the one or more computer processors, at least one image of a deformed spine, generating, by the one or more computer processors, a normal spinal curvature, and generating, by the one or more computer processors, a segmented alignment rod design.

[0049] In some embodiments, the method further comprises sending, by the one or more computer processors, the segmented alignment rod design to a segmented alignment rod creation machine. In some embodiments, the method further comprises, after the step of receiving the at least one image of the deformed spine, processing, by the one or more computer processors, the at least one image of the deformed spine. In some embodiments, the step of processing the at least one image of the deformed spine comprises measuring, by the one or more computer processors, the deformed spine. In some embodiments, the step of measuring the deformed spine comprises measuring, by the one or more computer processors, one or more vertebra and one or more discs of the deformed spine, and measuring, by the one or more computer processors, a curvature of the deformed spine. In some embodiments, the step of processing the at least one image of the deformed spine comprises measuring, by the one or more computer processors, one or more vertebra and one or more discs of the deformed spine, and measuring, by the one or more computer processors, a curvature of the deformed spine. In some embodiments, the step of generating the segmented alignment rod design comprises, based on the at least one image received, determining, by the one or more computer processors, a number of segments in the segmented alignment rod design, and based on the measurements and the normal spinal curvature, determining, by the one or more computer processors, a curvature of each of the segments. In some embodiments, the step of generating the segmented alignment rod design comprises, based on the at least one image received, determining, by the one or more computer processors, a number of segments in the segmented alignment rod design, and based on the measurements, determining, by the one or more computer processors, a male engaging element shape and a female engaging element shape for each of the segments. In some embodiments, the step of generating the segmented alignment rod design comprises, based on the at least one image received, determining, by the one or more computer processors, a number of segments in the segmented alignment rod design, and based on the measurements, determining, by the one or more computer processors, a length of each of the segments. In some embodiments, the step of generating the segmented alignment rod design comprises, based on the at least one image received, determining, by the one or more computer processors, a number of segments in the segmented alignment rod design and a length of each of the segments. In some embodiments, the step of generating the segmented alignment rod design further comprises estimating, by the one or more computer processors, a total length of growth of the deformed spine, and based on the measurements and the estimated total length of growth, determining, by the one or more computer processors, the length of each of the segments. In some embodiments, the step of receiving the request for the segmented alignment rod comprises, receiving, by the one or more computer processors, data related to a patient. In some embodiments, the data comprises an age and height. In some embodiments, the step of generating the normal spinal curvature comprises comparing, by the one or more computer processors, the data to a plurality of normal spinal curvatures in a database, selecting, by the one or more computer processors, one spinal curvature of the plurality of normal spinal curvatures, and generating, by the one or more computer processors, the normal spinal curvature based on dimensions of the selected normal spinal curvature. [0050] According to aspects illustrated herein, there is provided a computer system for creating a segmented alignment rod, comprising an imaging machine, one or more computer processors, one or more computer readable storage media, program instructions stored on the computer readable storage media for execution by at least one or more computer processors, the program instructions comprising program instructions to receive a request for a segmented alignment rod, program instructions to receive at least one image of a deformed spine from the imaging machine, program instructions to generate a normal spinal curvature, and program instructions to generate a segmented alignment rod design.

[0051] In some embodiments, the computer system further comprises program instructions to send the segmented alignment rod design to a segmented alignment rod creation machine. In some embodiments, the program instructions to receive the at least one image of the deformed spine comprise program instructions to receive the at least one image of the deformed spine, program instructions to measure one or more vertebra and one or more discs of the deformed spine, and program instructions to measure a curvature of the deformed spine. In some embodiments, the program instructions to generate the segmented alignment rod design comprise program instructions to, based on the at least one image received, determine a number of segments in the segmented alignment rod design, and program instructions to, based on the measurements, determine a length of each of the segments. In some embodiments, the program instructions to generate the segmented alignment rod design comprise program instructions to, based on the at least one image received, determine a number of segments in the segmented alignment rod design and a length of each of the segments. In some embodiments, the program instructions to receive the request for the segmented alignment rod comprise program instructions to receive data related to a patient. In some embodiments, the program instructions to generate the normal spinal curvature comprise program instructions to compare the data to a plurality of normal spinal curvatures in a database, program instructions to select one spinal curvature of the plurality of normal spinal curvatures, and program instructions to generate the normal spinal curvature based on dimensions of the selected normal spinal curvature.

[0052] According to aspects illustrated herein, there is provided a computer program product for creating a segmented alignment rod, comprising an imaging machine, a computer readable storage medium and program instructions stored on the computer readable storage medium, the program instructions comprising program instructions to receive a request for a segmented alignment rod, program instructions to receive at least one image of a deformed spine from the imaging machine, program instructions to process the at least one image to obtain dimensions of the deformed spine, program instructions to, based at least partially on the request, generate a normal spinal curvature, and program instructions to, based at least partially on the dimensions and the normal spinal curvature, generate a segmented alignment rod design.

[0053] In some embodiments, the program instructions to process the at least one image comprise program instructions to measure one or more vertebra and one or more discs of the deformed spine, and program instructions to measure a curvature of the deformed spine. In some embodiments, the program instructions to receive a request for the segmented alignment rod comprise program instructions to receive an age and height of a patient.

[0054] These and other objects, features, and advantages of the present disclosure will become readily apparent upon a review of the following detailed description of the disclosure, in view of the drawings and appended claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0055] Various embodiments are disclosed, by way of example only, with reference to the accompanying schematic drawings in which corresponding reference symbols indicate corresponding parts, in which:

Figure l is a stylized posterior view of a person with a spine afflicted with scoliosis; Figure 2 is a rear view of a person with scoliosis wearing a full body brace as known in the prior art;

Figure 3 is a rear view similar to that of Figure 2 but showing a lighter prior art brace;

Figure 4A is a perspective view of a segmented rod assembly;

Figure 4B is a perspective view of the segmented rod assembly shown in Figure 4A, in a rigid rod alignment; Figure 5 is a side elevational view of the segmented rod assembly shown in Figure 4A;

Figure 6 is a partial cross-sectional view of the segmented rod assembly taken generally along line 6-6 in Figure 4A;

Figure 7 is a perspective view of a segmented rod assembly;

Figure 8 is a cross-sectional view of the segmented rod assembly taken generally along line 8-8 in Figure 7;

Figure 9A is a posterior elevational view of a segmented rod assembly connected to a pathologic spine;

Figure 9B is a posterior elevational view of the segmented rod assembly connected to the pathologic spine shown in Figure 9A, with the segmented rod assembly partially engaged;

Figure 9C is a posterior elevational view of the segmented rod assembly connected to the pathologic spine shown in Figure 9A, with the segmented rod assembly fully engaged;

Figure 9D is a sagittal elevational view of the segmented rod assembly connected to the pathologic spine shown in Figure 9C;

Figure 10 is a functional block diagram illustrating an environment, in accordance with some embodiments of the present disclosure;

Figure 11 is a flow chart depicting operational steps for generating a customized segmented alignment rod;

Figure 12 is a block diagram of internal and external components of a computer system, in accordance with some embodiments of the present disclosure;

Figure 13 A is a stylized lateral view of a person with a normal spine;

Figure 13B is a line indicating the sagittal curvature of the spine shown in Figure 13 A;

Figure 14A is a stylized posterior view of a person with a normal spine;

Figure 14B is a line indicating the frontal curvature of the spine shown in Figure 14A;

Figure 15A is a stylized lateral view of a person with a spine afflicted with kyphosis;

Figure 15B is a line indicating the sagittal curvature of the spine shown in Figure 15 A;

Figure 16A is a stylized lateral view of a person with a spine afflicted with lordosis;

Figure 16B is a line indicating the sagittal curvature of the spine shown in Figure 16A;

Figure 17A is a stylized lateral view of a person with a spine afflicted with flat back;

Figure 17B is a line indicating the sagittal curvature of the spine shown in Figure 17A; Figure 18A is a stylized posterior view of a person with a spine afflicted with scoliosis; Figure 18B is a line indicating the frontal curvature of the spine shown in Figure 18 A; Figure 19A is a lateral elevational view of a segmented alignment rod;

Figure 19B is a posterior elevational view of the segmented alignment rod shown in Figure 19 A;

Figure 20A is a perspective view of a segment of a segmented alignment rod;

Figure 20B is a side elevational view of the segment shown in Figure 20A;

Figure 21 is a perspective view of a segment of a segmented alignment rod; and,

Figure 22 is a side elevational view of the segment shown in Figure 21, engaged with an adjacent segment of the segmented alignment rod.

DETAILED DESCRIPTION

[0056] At the outset, it should be appreciated that like drawing numbers on different drawing views identify identical, or functionally similar, structural elements. It is to be understood that the claims are not limited to the disclosed aspects.

[0057] Furthermore, it is understood that this disclosure is not limited to the particular methodology, materials and modifications described and as such may, of course, vary. It is also understood that the terminology used herein is for the purpose of describing particular aspects only, and is not intended to limit the scope of the claims.

[0058] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood to one of ordinary skill in the art to which this disclosure pertains. It should be understood that any methods, devices or materials similar or equivalent to those described herein can be used in the practice or testing of the example embodiments. The assembly of the present disclosure could be driven by hydraulics, electronics, pneumatics, and/or springs.

[0059] It should be appreciated that the term “substantially” is synonymous with terms such as “nearly,” “very nearly,” “about,” “approximately,” “around,” “bordering on,” “close to,” “essentially,” “in the neighborhood of,” “in the vicinity of,” etc., and such terms may be used interchangeably as appearing in the specification and claims. It should be appreciated that the term “proximate” is synonymous with terms such as “nearby,” “close,” “adjacent,” “neighboring,” “immediate,” “adjoining,” etc., and such terms may be used interchangeably as appearing in the specification and claims. The term “approximately” is intended to mean values within ten percent of the specified value.

[0060] It should be appreciated that the apex vertebra, apex, or apex of the curve is the vertebra or disk with the greatest rotation or farthest deviation from the center of the vertebral column. End vertebrae are those with the maximal tilt toward the apex of the curve. “Marked vertebra” as used herein is meant to indicate the vertebra (or vertebrae) which needs to travel the furthest in order that the spinal column be properly aligned according to a normal curvature, or a vertebra (or vertebrae) that is deemed essential in properly aligning the spinal column to a normal curvature. [0061] Referring now to the figures, Figure 4A is a perspective view of segmented rod assembly 10. Segmented rod assembly 10 comprises rod 20, tensioning member 50, and biasing element 200. Segmented rod assembly 10 may be enclosed or at least partially enclosed in a flexible sheath 12. In some embodiments, sheath 12 comprises a biocompatible material or fabric (e.g., polyethylene) to prevent tissue ingress or growth between rod segments. [0062] Rod 20 comprises a plurality of segments arranged adjacent each other along tensioning member 50. In the embodiment shown, rod 20 is generally a hollow rod comprising segments 22A-C and 32. Segments 22A-C and 32 are substantially similar, but may differ slightly from each other and in length. Preferably, each of segments 22A-C and 32 comprises a length which is similar to that of the height of a vertebra. In an example embodiment, the segments arranged proximate an extreme curvature of a pathologic spine may comprise a smaller height than the segments proximate a straighter spine curvature. This arrangement allows for a more gradual and efficient straightening of the pathologic spine. Rod 20 may comprise plastic (e.g., polyethylene), titanium, chromium, cobalt, or any other suitable material.

[0063] Segment 22A comprises body 24A, end 26A, end 28A, and one or more tangs 30A. Tangs 30A are connected to end 28A and extend therefrom. Tangs 30A are arranged to engage channels 31B of segment 22B. In some embodiments, tangs 30A are arranged in alignment with an outer surface of body 24A (i.e., the radially outward facing surface of tangs 30A are aligned with the radial outward facing surface of body 24A). In some embodiments, and as shown, tangs 30A are generally triangular shaped and form a point or rounded point. The triangular shape of tangs 30A allow segment 22A to laterally pivot/flex, and rotate, with respect to segment 22B. It should be appreciated, however, that tangs 30A may comprise any geometry suitable for gradually engaging an adjacent segment, for example, rectangular, circular, semi circular, ovular, trapezoidal, etc. Segment 22A further comprises a through-bore that extends from end 26A to end 28A, thereby allowing tensioning member 50 to pass at least partially therethrough. By arranging tangs 30A on or proximate the outer surface of body 24A, a more substantial (i.e., thicker) tensioning member 50 may be used as there is no tapered portion of segment 22A arranged to engage the through-bore of segment 22B.

[0064] Segment 22B comprises body 24B, end 26B, end 28B, one or more tangs 30B, and one or more channels 31B. Tangs 30B are connected to end 28B and extend therefrom. Tangs 30B are arranged to engage channels 31C of segment 22C. In some embodiments, tangs 30B are arranged in alignment with an outer surface of body 24B (i.e., the radially outward facing surface of tangs 30B are aligned with the radial outward facing surface of body 24B). In some embodiments, and as shown, tangs 30B are generally triangular shaped and form a point or rounded point. The triangular shape of tangs 30B allows segment 22B to laterally pivot/flex, and rotate, with respect to segment 22C. It should be appreciated, however, that tangs 30B may comprise any geometry suitable for gradually engaging an adjacent segment, for example, rectangular, circular, semi-circular, ovular, trapezoidal, etc. Segment 22B further comprises a through-bore that extends from end 26B to end 28B, thereby allowing tensioning member 50 to pass at least partially therethrough. By arranging tangs 30B on or proximate the outer surface of body 24B, a more substantial (i.e., thicker) tensioning member 50 may be used as there is no tapered portion of segment 22B arranged to engage the through-bore of segment 22C. Channels 31B are generally notches/indentations in the outer surface of body 24B arranged proximate end 26B. In some embodiments, and as shown, channels 31B are triangular shaped such that they are engageable with tangs 30A of segment 22A. As previously discussed, the engagement of the generally triangular-shaped tangs 30A with channels 31B allows segment 22A to pivot/flex and rotate with respect to segment 22B when tangs 30A are partially engaged with channels 31B. When tangs 30A are fully engaged with channels 31B and force is applied appropriately by tensioning member 50, segment 22A is rigidly secured to segment 22B, as will be described in greater detail below. [0065] Segment 22C comprises body 24C, end 26C, end 28C, one or more tangs 30C, and one or more channels 31C. Tangs 30C are connected to end 28C and extend therefrom. Tangs 30C are arranged to engage channels 41 of segment 32. In some embodiments, tangs 30C are arranged in alignment with an outer surface of body 24C (i.e., the radially outward facing surface of tangs 30C are aligned with the radial outward facing surface of body 24C). In some embodiments, and as shown, tangs 30C are generally triangular shaped and form a point or rounded point. The triangular shape of tangs 30C allows segment 22C to laterally pivot/flex, and rotate, with respect to segment 32. It should be appreciated, however, that tangs 30C may comprise any geometry suitable for gradually engaging an adjacent segment, for example, rectangular, circular, semi-circular, ovular, trapezoidal, etc. Segment 22C further comprises a through-bore that extends from end 26C to end 28C, thereby allowing tensioning member 50 to pass at least partially therethrough. By arranging tangs 30C on or proximate the outer surface of body 24C, a more substantial (i.e., thicker) tensioning member 50 may be used as there is no tapered portion of segment 22C arranged to engage the through-bore of segment 32. Channels 31C are generally notches/indentations in the outer surface of body 24C arranged proximate end 26C. In some embodiments, and as shown, channels 31C are triangular shaped such that they are engageable with tangs 30B of segment 22B. As previously discussed, the engagement of the generally triangular- shaped tangs 30B with channels 31C allows segment 22B to pivot/flex and rotate with respect to segment 22C when tangs 30B are partially engaged with channels 31C. When tangs 30B are fully engaged with channels 31C and force is applied appropriately by tensioning member 50, segment 22B is rigidly secured to segment 22C, as will be described in greater detail below.

[0066] Segment 32 comprises body 34, end 36, end 38, and one or more channels 41.

Segment 32 further comprises a through-bore that extends from end 36 to end 38, thereby allowing tensioning member 50 to pass at least partially therethrough. Channels 41 are generally notches/indentations in the outer surface of body 34 arranged proximate end 36. In some embodiments, and as shown, channels 41 are triangular shaped such that they are engageable with tangs 30C of segment 22C. As previously discussed, the engagement of the generally triangular- shaped tangs 30C with channels 41 allows segment 22C to pivot/flex and rotate with respect to segment 32 when tangs 30C are partially engaged with channels 41. When tangs 30C are fully engaged with channels 41 and force is applied appropriately by tensioning member 50, segment 22C is rigidly secured to segment 32, as will be described in greater detail below. Biasing element 200 may be arranged within or proximate to segment 32, as will be discussed in greater detail below.

[0067] It should be appreciated that rod 20 may comprise any number of segments (e.g., a plurality of segments) suitable to be secured to and gradually straighten a pathologic spine, and that this disclosure is not limited to only the use of four segments. As is apparent to one having ordinary skill in the art, rod 20 must comprise enough segments to adequately canvas the subject curvature of the pathologic spine. Further, it should be appreciated that while the segments of rod 20 are shown to be generally cylindrical (i.e., the cross-sectional geometry of each section is circular), the segments may comprise any suitable cross-sectional geometry (e.g., square, rectangular, ovular, ellipsoidal, trapezoidal, polygonal, etc.).

[0068] Tensioning member 50 is arranged inside of rod 20. Specifically, tensioning member 50 passes at least partially through segments 22A-C and 32. In the embodiment shown, tensioning member 50 is embodied as line 51 having end 52 and end 54. Line 51 may be a cable, plurality of cables, string, rope, chain, or any other flexible material suitable to draw segments 22A-C and 32 together upon tautening. End 52 is connected to plate 42. Plate 42 is arranged to abut against or connect to end 26A. In some embodiments, plate 42 is integrally formed with segment 22A and is fixed to end 26A. In some embodiments, end 52 is connected to segment 22A. End 54 is connected to a tensioning or biasing element (e.g., biasing element 200). The arrangement of segments 22A-C and 32 on line 51 resembles that of beads on a string. As line 51 is tautened via biasing element 200, plate 42 pulls segments 22A-C and 32 together. As segments 22A-C and 32 begin to engage, rod 20 becomes increasingly rigid. Once segments 22A-C and 32 are fully engaged, rod 20 resembles a single rigid rod (see Figure 4B).

[0069] In some embodiments, end 54 may be connected to a turnbuckle rod which threadably engages segment 32. Specifically, the turnbuckle rod is a threaded rod which threadably engages end 38 at a first end and has a hook at its second end which is connected to end 54 of line 51. As the turnbuckle rod is rotated, the hook pulls end 54 toward end 38 and thereby tautens line 51. In some embodiments, end 52 may be connected to a turnbuckle rod which threadably engages segment 22A. Specifically, the turnbuckle rod is a threaded rod which threadably engages end 26A at a first end and has a hook at its second end which is connected to end 52 of line 51. As the turnbuckle rod is rotated, the hook pulls end 52 toward end 26A and thereby tautens line 51. In an example embodiment, there are turnbuckles arranged in both segment 22A and 32. Line 51 may be connected to a hook on the respective turnbuckle rod via a loop or directly connected to the respective turnbuckle via welding, adhesives, etc.

[0070] Segmented rod assembly 10 further comprises a plurality of anchors. As shown, segmented rod assembly 10 comprises anchors 60, 62, and 64 for connecting rod 20 to the pathologic spine. Anchor 60 is slidably connected to segment 22A and is secured to a cranial vertebra using, for example, a spinous process clamp, a pedicle screw, or other similar method of fixation. Anchor 60 is slidably connected to segment 22A such that as the pathologic spine straightens, and thereby lengthens, segmented rod assembly 10 adjusts to the length of the spine. To account for the increase in length, segment 22A may be significantly longer than the other segments. Anchor 62 is fixedly secured to segment 32 and is secured to a caudal vertebra using, for example, a spinous process clamp, a pedicle screw, or other similar method of fixation. In some embodiments, anchor 62 is slidably secured to segment 32. Anchor 64 is slidably connected to segment 22C and is connected to the apex vertebra. Similar to anchor 60, anchor 64 is slidably connected to segment 22C to adjust for the straightening and lengthening of the spine. In an example embodiment, anchor 64 is fixedly connected to segment 22C. It should be appreciated that anchor 64 does not need to be slidably connected to segment 22C, but can be connected to any segment that is arranged near the apex vertebra such that the pathologic spine may be suitably straightened.

[0071] Figure 4B is a perspective view of segmented rod assembly 10 in a rigid rod alignment. As shown, the segments of rod 20 are fully engaged with each other. Line 51 is tautened by biasing element 200 such that plate 42 is pulled toward biasing element 200 (i.e., generally in axial direction ADI). Plate 42 abuts against end 26A of segment 22A. Tangs 30A are fully engaged with channels 31B of segment 22B such that end 28A abuts against end 26B. Tangs 30B are fully engaged with channels 31C of segment 22C such that end 28B abuts against end 26C. Tangs 30C are fully engaged with channels 41 of segment 32 such that end 28C abuts against end 36. It should be appreciated that even when the tangs are fully engaged with the channels, there may still be flexion within rod 20 to allow for normal flexion of a spine. [0072] It should be appreciated that rod 20, when rigid, does not need to form a linear rod. The design of rod 20, when rigid, imitates the normal curvature of the human spine (i.e., thoracic curvature, sacral curvature, lumbar curvature, cervical curvature, lateral curvature, etc.). Figure 4B demonstrates simply how the various segments engage in order form a rigid rod. The rod shown in Figure 4B could be employed to correct lateral curvature of a pathologic spine.

[0073] Figure 5 is a side elevational view of segmented rod assembly 10. In the most disengaged state (i.e., when the tangs are barely engaged with the channels of an adjacent segment), the segments are capable of the most movement with respect to each other (i.e., segments may pivot, flex, and rotate with respect to each other). As tensioning member 50 is drawn in axial direction ADI and the tangs further engage the channels, less movement between the segments occurs. Thus, the more engaged the tangs are with the channels, the stiffer rod 20 becomes.

[0074] Figure 6 is a partial cross-sectional view of segmented rod assembly 10 taken generally along line 6-6 in Figure 4A. Specifically, Figure 6 shows a cross-sectional view of segment 32. In some embodiments, and as shown, biasing element 200 is arranged in segment 32 in order to bias tensioning member 50 generally in axial direction ADI. In some embodiments, biasing element 200 comprises a motor, for example, a direct current (DC) motor (e.g., a coreless brushed DC motor, a servo motor, etc.). The motor of biasing element 200 may be used instead of or in addition to a spring biasing mechanism. In some embodiments, the motor of biasing element 200 may be triggered by slackness sensed in tensioning member 50, and thus segmented rod assembly 10 may comprise one or more sensors operatively arranged to detect slack in tensioning member 50 and communicate with biasing element 200. In such embodiments, the slackness in tensioning member 50 would trigger a sensor that starts the motor and the motor would turn and wind tensioning member 50. In some embodiments, the motor turns a threaded screw connected to tensioning member 50 to tauten tensioning member 50. In some embodiments, the motor of biasing element 200 may be activated wirelessly, via a wireless controller. It should be appreciated that biasing element 200 may be alternatively arranged adjacent or proximate to end 38, outside of segment 32.

[0075] In some embodiments, tensioning member 50 comprises one or more muscle wires. As is known in the art, muscle wires or bio metal are easily stretched by a small force. However, when an electrical current is introduced therein, the wire heats and changes to a much harder form that returns to the unstretched shape, and thus the wore shortens with a usable amount of force. In some embodiments, tensioning member 50 comprises one or more muscle wires and biasing element 200 is operatively arranged to introduce an electric current into tensioning member 50, such that tensioning member 50 shortens and biases segment 22A toward segment 32. Electric current may be introduced into tensioning member 50 via a servo based receiving unit.

[0076] Further, in some embodiments, and as shown, segment 32 may comprise one or more teeth 46 operatively arranged to engage one or more teeth 56 arranged on tensioning member 50. The engagement of teeth 56 with 46 allows tensioning member 50 to displace in axial direction ADI but not axial direction AD2. In some embodiments, segment 32 comprises a ratchet assembly that engages with teeth 56 that allows tensioning member 50 to displace in axial direction ADI but not axial direction AD2. Biasing element 200 may be directly connected to tensioning member 50 or may be connected through connector 48. In some embodiments biasing element 200 comprises a worm drive and/or a ratchet assembly.

[0077] Figure 7 is a perspective view of segmented rod assembly 110. Figure 8 is a cross- sectional view of segmented rod assembly 110 taken generally along line 8-8 in Figure 7. Segmented rod assembly 110 comprises rod 210, at least one tensioning member (e.g., tensioning members 150A-B), and one or more biasing elements 300. Segmented rod assembly 110 may be enclosed or at least partially enclosed in a flexible sheath 112. In some embodiments, sheath 112 comprises a biocompatible material or fabric (e.g., polyethylene) to prevent tissue ingress or growth between rod segments.

[0078] Rod 120 comprises a plurality of segments arranged adjacent each other along tensioning members 150A-B. In the embodiment shown, rod 120 is generally a hollow rod comprising segments 122A-E and 132. Segments 122A-E and 132 are substantially similar, but may differ slightly from each other and in length. Preferably, each of segments 122A-E and 132 comprises a length which is similar to that of the height of a vertebra. In an example embodiment, the segments arranged proximate an extreme curvature of a pathologic spine may comprise a smaller height than the segments proximate a straighter spine curvature. This arrangement allows for a more gradual and efficient straightening of the pathologic spine. Rod 120 may comprise plastic (e.g., polyethylene), titanium, chromium, cobalt, or any other suitable material.

[0079] Segment 122A comprises body 124A, end 126A, end 128A, and one or more tangs 130A. Tangs 130A are connected to end 128A and extend therefrom. Tangs 130A are arranged to engage channels 131B of segment 122B. In some embodiments, tangs 130A are arranged in alignment with an outer surface of body 124A (i.e., the radially outward facing surface of tangs 130A are aligned with the radial outward facing surface of body 124A). In some embodiments, and as shown, tangs 130A are generally triangular shaped and form a point or rounded point. The triangular shape of tangs 130A allow segment 122A to laterally pivot/flex, and rotate, with respect to segment 122B. It should be appreciated, however, that tangs 130A may comprise any geometry suitable for gradually engaging an adjacent segment, for example, rectangular, circular, semi-circular, ovular, trapezoidal, etc. Segment 122A further comprises a through-bore that extends from end 126A to end 128A, thereby allowing tensioning member 150A to pass at least partially therethrough. By arranging tangs 130A on or proximate the outer surface of body 124A, a more substantial (i.e., thicker) tensioning member 150A may be used as there is no tapered portion of segment 122A arranged to engage the through-bore of segment 122B.

[0080] Segment 122B comprises body 124B, end 126B, end 128B, one or more tangs

130B, and one or more channels 131B. Tangs 130B are connected to end 128B and extend therefrom. Tangs 130B are arranged to engage channels 131C of segment 122C. In some embodiments, tangs 130B are arranged in alignment with an outer surface of body 124B (i.e., the radially outward facing surface of tangs 130B are aligned with the radial outward facing surface of body 124B). In some embodiments, and as shown, tangs 130B are generally triangular shaped and form a point or rounded point. The triangular shape of tangs 130B allows segment 122B to laterally pivot/flex, and rotate, with respect to segment 122C. It should be appreciated, however, that tangs 130B may comprise any geometry suitable for gradually engaging an adjacent segment, for example, rectangular, circular, semi-circular, ovular, trapezoidal, etc. Segment 122B further comprises a through-bore that extends from end 126B to end 128B, thereby allowing tensioning member 150A to pass at least partially therethrough. By arranging tangs 130B on or proximate the outer surface of body 124B, a more substantial (i.e., thicker) tensioning member 150A may be used as there is no tapered portion of segment 122B arranged to engage the through-bore of segment 122C. Channels 131B are generally notches/indentations in the outer surface of body 124B arranged proximate end 126B. In some embodiments, and as shown, channels 131B are triangular shaped such that they are engageable with tangs 130A of segment 122A. As previously discussed, the engagement of the generally triangular-shaped tangs 130A with channels 131B allows segment 122A to pivot/flex and rotate with respect to segment 122B when tangs 130A are partially engaged with channels 131B. When tangs 130A are fully engaged with channels 131B and force is applied appropriately by tensioning member 150A, segment 122A is rigidly secured to segment 122B, as will be described in greater detail below. [0081] Segment 122C comprises body 124C, end 126C, end 128C, one or more tangs

130C, and one or more channels 131C. Tangs 130C are connected to end 128C and extend therefrom. Tangs 130C are arranged to engage channels 131D of segment 122D. In some embodiments, tangs 130C are arranged in alignment with an outer surface of body 124C (i.e., the radially outward facing surface of tangs 130C are aligned with the radial outward facing surface of body 124C). In some embodiments, and as shown, tangs 130C are generally triangular shaped and form a point or rounded point. The triangular shape of tangs 130C allows segment 122C to laterally pivot/flex, and rotate, with respect to segment 122D. It should be appreciated, however, that tangs 130C may comprise any geometry suitable for gradually engaging an adjacent segment, for example, rectangular, circular, semi-circular, ovular, trapezoidal, etc. Segment 122C further comprises a through-bore that extends from end 126C to end 128C, thereby allowing tensioning members 150A-B to pass at least partially therethrough. By arranging tangs 130C on or proximate the outer surface of body 124C, more substantial (i.e., thicker) tensioning members 150A-B may be used as there is no tapered portion of segment 122C arranged to engage the through-bore of segment 122D. Channels 131C are generally notches/indentations in the outer surface of body 124C arranged proximate end 126C. In some embodiments, and as shown, channels 131C are triangular shaped such that they are engageable with tangs 130B of segment 122B. As previously discussed, the engagement of the generally triangular-shaped tangs 130B with channels 131C allows segment 122B to pivot/flex and rotate with respect to segment 122C when tangs 130B are partially engaged with channels 131C. When tangs 130B are fully engaged with channels 131C and force is applied appropriately by tensioning member 150A, segment 122B is rigidly secured to segment 122C, as will be described in greater detail below. Biasing element 300 may be arranged within or proximate to segment 122C, as will be discussed in greater detail below.

[0082] Segment 122D comprises body 124D, end 126D, end 128D, one or more tangs

130D, and one or more channels 131D. Tangs 130D are connected to end 128D and extend therefrom. Tangs 130D are arranged to engage channels 131E of segment 122E. In some embodiments, tangs 130D are arranged in alignment with an outer surface of body 124D (i.e., the radially outward facing surface of tangs 130D are aligned with the radial outward facing surface of body 124D). In some embodiments, and as shown, tangs 130D are generally triangular shaped and form a point or rounded point. The triangular shape of tangs 130D allows segment 122D to laterally pivot/flex, and rotate, with respect to segment 122E. It should be appreciated, however, that tangs 130D may comprise any geometry suitable for gradually engaging an adjacent segment, for example, rectangular, circular, semi-circular, ovular, trapezoidal, etc. Segment 122D further comprises a through-bore that extends from end 126D to end 128D, thereby allowing tensioning member 150B to pass at least partially therethrough. By arranging tangs 130D on or proximate the outer surface of body 124D, a more substantial (i.e., thicker) tensioning member 150B may be used as there is no tapered portion of segment 122D arranged to engage the through-bore of segment 122E. Channels 131D are generally notches/indentations in the outer surface of body 124D arranged proximate end 126D. In some embodiments, and as shown, channels 131D are triangular shaped such that they are engageable with tangs 130C of segment 122C. As previously discussed, the engagement of the generally triangular-shaped tangs 130C with channels 131D allows segment 122C to pivot/flex and rotate with respect to segment 122D when tangs 130C are partially engaged with channels 131D. When tangs 130C are fully engaged with channels 131D and force is applied appropriately by tensioning member 150B, segment 122C is rigidly secured to segment 122D, as will be described in greater detail below. [0083] Segment 122E comprises body 124E, end 126E, end 128E, one or more tangs

130E, and one or more channels 131E. Tangs 130E are connected to end 128E and extend therefrom. Tangs 130E are arranged to engage channels 141 of segment 132. In some embodiments, tangs 130E are arranged in alignment with an outer surface of body 124E (i.e., the radially outward facing surface of tangs 130E are aligned with the radial outward facing surface of body 124E). In some embodiments, and as shown, tangs 130E are generally triangular shaped and form a point or rounded point. The triangular shape of tangs 130E allows segment 122E to laterally pivot/flex, and rotate, with respect to segment 132. It should be appreciated, however, that tangs 130E may comprise any geometry suitable for gradually engaging an adjacent segment, for example, rectangular, circular, semi-circular, ovular, trapezoidal, etc. Segment 122E further comprises a through-bore that extends from end 126E to end 128E, thereby allowing tensioning member 150 to pass at least partially therethrough. By arranging tangs 130E on or proximate the outer surface of body 124E, a more substantial (i.e., thicker) tensioning member 150B may be used as there is no tapered portion of segment 122E arranged to engage the through-bore of segment 132. Channels 131E are generally notches/indentations in the outer surface of body 124E arranged proximate end 126E. In some embodiments, and as shown, channels 131E are triangular shaped such that they are engageable with tangs 130D of segment 122D. As previously discussed, the engagement of the generally triangular-shaped tangs 130D with channels 131E allows segment 122D to pivot/flex and rotate with respect to segment 122E when tangs 130D are partially engaged with channels 131E. When tangs 130D are fully engaged with channels 131E and force is applied appropriately by tensioning member 150B, segment 122D is rigidly secured to segment 122E, as will be described in greater detail below.

[0084] Segment 132 comprises body 134, end 136, end 138, and one or more channels

141. Segment 132 further comprises a through-bore that extends from end 136 to end 138, thereby allowing tensioning member 150 to pass at least partially therethrough. Channels 141 are generally notches/indentations in the outer surface of body 134 arranged proximate end 136. In some embodiments, and as shown, channels 141 are triangular shaped such that they are engageable with tangs 130E of segment 122E. As previously discussed, the engagement of the generally triangular-shaped tangs 130E with channels 141 allows segment 122E to pivot/flex and rotate with respect to segment 132 when tangs 130E are partially engaged with channels 141. When tangs 130E are fully engaged with channels 141 and force is applied appropriately by tensioning member 150B, segment 122E is rigidly secured to segment 132, as will be described in greater detail below. Biasing element 300 may be arranged within or proximate to segment 132, as will be discussed in greater detail below. [0085] It should be appreciated that rod 120 may comprise any number of segments (e.g., a plurality of segments) suitable to be secured to and gradually straighten a pathologic spine, and that this disclosure is not limited to only the use of six segments. As is apparent to one having ordinary skill in the art, rod 120 must comprise enough segments to adequately canvas the subject curvature of the pathologic spine. Further, it should be appreciated that while the segments of rod 120 are shown to be generally square/rectangular (i.e., the cross-sectional geometry of each section is square/rectangular), the segments may comprise any suitable cross- sectional geometry (e.g., circular, ovular, ellipsoidal, trapezoidal, polygonal, etc.).

[0086] Tensioning members 150A-B are arranged inside of rod 120. Specifically, tensioning member 150A passes at least partially through segments 122A-C and tensioning member 150B passes at least partially through segments 122C-E and 132. It should be appreciated that any number of tensioning members may be used (e.g., one or more tensioning members), and that each tensioning member may pass through any number of segments. For example, in some embodiments, a first tensioning member is arranged to connect segments 122A-B, a second tensioning member is arranged to connect segment 122B-C, a third tensioning member is arranged to connect segments 122C-E, and a fourth tensioning member is arranged connect segments 122E and 132. By using multiple tensioning members to connect various segments throughout rod 120, the force required to pull the segments into full engagement with each other is less than the force required with one tensioning member throughout all of the segments. In the embodiment shown, tensioning member 150A comprises end 152A and end 154A, and tensioning member 150B comprises end 152B and end 154B. Each of tensioning members 150A-B may comprise a cable, plurality of cables, string, rope, chain, or any other flexible material suitable to draw segments 122A-E and 132 together upon tautening. End 152A is connected to plate 142. Plate 142 is arranged to abut against or connect to end 126A. In some embodiments, plate 142 is integrally formed with segment 122A and is fixed to end 126A. In some embodiments, end 152A is connected to segment 122A. End 154A is connected to a tensioning or biasing element (e.g., biasing element 300) arranged in another segment (e.g., segment 122C). The arrangement of segments 122A-C on tensioning member 150A resembles that of beads on a string. As tensioning member 150A is tautened via biasing element 300, plate 142 pulls segments 122A-C together. As segments 122A-C begin to engage, rod 120 becomes increasingly rigid. Once segments 122A-C are fully engaged, that portion of rod 120 resembles a single rigid rod. End 152B is connected to segment 122C. End 154B is connected to a tensioning or biasing element (e.g., biasing element 300) arranged in another segment (e.g., segment 132). The arrangement of segments 122C-E and 132 on tensioning member 150B resembles that of beads on a string. As tensioning member 150B is tautened via biasing element 300, segments 122C-E and 132 together are pulled together. As segments 122C-E and 132 begin to engage, that portion of rod 120 becomes increasingly rigid. Once segments 122C-E and 132 are fully engaged, that portion of rod 120 resembles a single rigid rod.

[0087] Segmented rod assembly 110 may further comprises a plurality of anchors. For example, segmented rod assembly 100 may comprise three anchors to connect segmented rod assembly 110 to the pathologic spine, as previously discussed with respect to segmented rod assembly 10

[0088] Similar to that of segmented rod assembly 10, the segments of rod 120 are fully engageable with each other (see Figures 9A-D). Tensioning members 150A-B are tautened by biasing elements 300 to pull segments 122A-E and 132 together. When fully engaged, plate 142 abuts against end 126A of segment 122A. Tangs 130A are fully engaged with channels 131B of segment 122B such that end 128A abuts against end 126B. Tangs 130B are fully engaged with channels 131C of segment 122C such that end 128B abuts against end 126C. Tangs 130C are fully engaged with channels 131D of segment 122D such that end 128C abuts against end 126D. Tangs 130D are fully engaged with channels 131E of segment 122E such that end 128D abuts against end 126E. Tangs 130E are fully engaged with channels 141 of segment 132 such that end 128E abuts against end 136. It should be appreciated that even when the tangs are fully engaged with the channels, there may still be flexion within rod 120 to allow for normal flexion of a spine. [0089] It should be appreciated that rod 120, when rigid, does not need to form a linear rod. The design of rod 120, when rigid, imitates the normal curvature of the human spine (i.e., thoracic curvature, sacral curvature, lumbar curvature, cervical curvature, lateral curvature, etc.). Figures 9A-D demonstrate how the various segments engage in order form a rigid rod to correct lateral curvature of a pathologic spine, while maintaining the normal curvature of the spine. [0090] In the most disengaged state (i.e., when the tangs are barely engaged with the channels of an adjacent segment), the segments are capable of the most movement with respect to each other (i.e., segments may pivot, flex, and rotate with respect to each other). As tensioning member 150A and/or 150B is taughtened and the tangs further engage the channels, less movement between the segments occurs. Thus, the more engaged the tangs are with the channels, the stiffer rod 120 becomes.

[0091] In some embodiments, one or more biasing elements 300 are arranged in or proximate to one or more segments throughout segmented rod assembly 110. For example, as shown in Figure 8, biasing elements 300 are arranged in segments 122C and 132 in order to bias tensioning member 150A and 150B, respectively, generally in axial direction ADI. In some embodiments, each of biasing elements 300 comprises a motor, for example, a direct current (DC) motor (e.g., a coreless brushed DC motor, a servo motor, etc.). The motor of biasing element 300 may be used instead of or in addition to a spring biasing mechanism. In some embodiments, the motor of biasing element 300 may be triggered by slackness sensed in tensioning members 150A-B, and thus segmented rod assembly 110 may comprise one or more sensors operatively arranged to detect slack in tensioning members 150A-B and communicate with biasing element 300. In such embodiments, slackness in tensioning members 150A-B would trigger a sensor that starts the motor and the motor would turn and wind tensioning members 150A and/or 150B. In some embodiments, the motor turns a threaded screw connected to the respective tensioning member to tauten the tensioning member. In some embodiments, the motor of biasing element 300 may be activated wirelessly, via a wireless controller. For example, and as shown, each of biasing elements 300 may comprise a respective transducer 400. Transducer 400 is operatively arranged to receive a signal from a remote location, for example from controller 410 (see Figure 9B), and activate or deactivate biasing element 300. In such embodiments, transducer 400 may receive a signal from control 410 and activate biasing element 300 to pull its respective tensioning member (e.g., 150A) thereby tightening its respective segments (e.g., segments 122A-C). Transducer 400 may also receive a signal from control 410 to deactivate biasing element 300 such that biasing element 300 discontinues pulling the respective tensioning member and instead maintains its functional length. It should be appreciated that biasing elements 300 may be alternatively arranged adjacent or proximate to the segments. [0092] In some embodiments, tensioning member 150A and/or 150B comprises one or more muscle wires. As is known in the art, muscle wires or bio metal are easily stretched by a small force. However, when an electrical current is introduced therein, the wire heats and changes to a much harder form that returns to the unstretched shape, and thus the wore shortens with a usable amount of force. In some embodiments, tensioning member 150A and/or 150B comprises one or more muscle wires and biasing element 300 is operatively arranged to introduce an electric current into the respective tensioning member, such that the tensioning member shortens and biases the segments together.

[0093] Further, and as previously described, in some embodiments one or more segments of segmented rod assembly 110 may comprise teeth or a ratchet assembly in order to allow the tensioning members to be pulled in a first direction but not a second direction. For example, tensioning member 150A may comprise teeth proximate end 154A that engage teeth or a ratchet assembly in segment 122C that allows tensioning member 150A to displace generally in axial direction ADI but not axial direction AD2. Similarly, tensioning member 150B may comprise teeth proximate end 154B that engage teeth or a ratchet assembly in segment 132 that allows tensioning member 150B to displace in axial direction ADI but not axial direction AD2. In some embodiments biasing elements 300 comprise a worm drive and/or a ratchet assembly.

[0094] Figure 9A is a posterior elevational view of segmented rod assembly 110 connected to (pathologic) spine 80. In the embodiment shown, rod 120 comprises segments 122A-N and 132 and three tensioning members (not shown). Segment 122A is slidably secured to cranial vertebra 82 via anchor 60. Cranial vertebra 82 is a vertebra of spine 80 generally located proximate cranium 90. Cranial vertebra 82 may also be the end vertebra of the curve on the cranial side. As is known in the art, the end vertebra of a curve is that with the maximal tilt toward the apex of the curve. Anchor 60 may be secured to the spinous process of cranial vertebra 82 using, for example, a spinous process clamp, pedicle screw, or any other suitable securing means. Segment 132 is fixedly secured to caudal vertebra 84 via anchor 62. In some embodiments, segment 132 is slidably connected to a caudal vertebra via anchor 62. Caudal vertebra 84 is a vertebra of spine 80 generally located proximate coccyx 92. Caudal vertebra 82 may also be the end vertebra of the curve on the caudal side. As is known in the art, the end vertebra of a curve is that with the maximal tilt toward the apex of the curve. Anchor 62 may be secured to the spinous process of caudal vertebra 84 using, for example, a spinous process clamp, pedicle screw, or any other suitable securing means. Segment 122H is connected to apex vertebra 86 via anchor 64. Apex vertebra 86 is a vertebra of spine 80 with the greatest rotation or farthest deviation from the center of the vertebral column. Anchor 64 may be secured to the spinous process of apex vertebra 86 using, for example, a spinous process clamp, pedicle screw, or any other suitable securing means. As shown, the tensioning members (not shown) have not yet been tautened, leaving segments 122B-N (and 132) to float relative to spine 80. Segment 122A may slide relative to spine 80. Segment 132 is fixedly secured to caudal vertebra 84 and therefore cannot move relative to spine 80. Segment 122H may be fixedly secured or slidingly connected to apex vertebra 86. Plate 142 is shown unconnected to segment 122A (as a separate component) however, in an example embodiment, plate 142 is fixedly secured to or integrally formed with segment 122A. It should be appreciated that segmented rod assembly 110 may be arranged on the opposite side of spine 80 (i.e., the left side). Segmented rod assembly 110 is shown offset from the vertebrae of spine 80. However, it should be appreciated that segmented rod assembly 110 can be arranged along the spino-laminar junction. It should also be appreciated that two segmented rod assemblies may be used on either side of the spinous process of spine 80 for added force.

[0095] Figure 9B is a posterior elevational view of segmented rod assembly 110 connected to (pathologic) spine 80. As shown, the tensioning members have been tautened via biasing elements 300 and segmented rod assembly 110 is partially engaged. Segments 122A-N and 132 of rod 120 are at least partially engaged with each other. Some of segments 122A-N and 132 may be fully engaged with each other. The tensioning members, for example, tensioning members 150A-C, should be taut, which results in straightening forces being asserted on (pathologic) spine 80. The straightening forces in the embodiment shown are designated by arrow F. Over time, these straightening forces will displace apex vertebra 86, and adjacent vertebrae, back into alignment with the rest of the vertebral column and thereby straighten spine 80. In the embodiment shown, segmented rod assembly 110 “pushes” apex vertebra 86 toward alignment with cranial vertebra 82 and caudal vertebra 84. However, segmented rod assembly 10 could be arranged on the opposite side of spine 80 (left side), and “pull” apex vertebra 86 toward alignment with cranial vertebra 82 and caudal vertebra 84. [0096] In the embodiment shown, there are three tensioning members: a first tensioning member connecting plate 142 and segments 122A-E, a second tensioning member connecting segments 122E-122J, and a third tensioning member connecting segments 122J-N and 132. A biasing element 300 having transducer 400 is arranged in segment 122E and connected to the first tensioning member, a biasing element 300 having transducer 400 is arranged in segment 122J and connected to the second tensioning member, and a biasing element 300 having transducer 400 is arranged in segment 132 and connected to the third tensioning member. Each biasing element 300 is arranged to communicate with control 410 via its respective transducer. Thus, each of the three tensioning members, representing three sections of rod 120, may be taughtened independently of the other tensioning members. Also, the force required to pull rod 120 into full engagement is split amongst three biasing elements.

[0097] Figure 9C is a posterior elevational view of segmented rod assembly 110 connected to spine 80 with rod 120 fully engaged. Figure 9D is a sagittal elevational view of segmented rod assembly 110 connected to spine 80 with rod 120 fully engaged. As shown, the tensioning members have been further tautened via biasing elements 300 and segmented rod assembly 110 is fully engaged. Segments 122A-N and 132 of rod 120 (i.e., their respective tangs and channels), are fully engaged with each other, which allows rod 120 to take its final rigid shape. It should be appreciated that, although rigid rod 120 is shown to be linear, rigid rod 120 can be designed with three-dimensional curvature to best suit the patient (see Figure 9D). As shown, apex vertebra 86 has been aligned with cranial vertebra 82 and caudal vertebra 84 to form a straightened spine 80.

[0098] It should be appreciated that the various segments of the present disclosure may be hollow or may be solid having a through-bore through which the tensioning member(s) extends. It should also be appreciated that the various segments of the present disclosure may include a plurality of through-bores through which a plurality of tensioning members extend.

[0099] Figure 10 is a functional block diagram illustrating a segmented alignment rod creation environment, generally designated 600, in accordance with some embodiments of the present disclosure. Figure 10 provides only an illustration of one implementation, and does not imply any limitations with regard to the environments in which different embodiments may be implemented. Many modifications to the depicted environment may be made by those skilled in the art without departing from the scope of the disclosure as recited by the claims. In some embodiments, segmented alignment rod creation environment 600 includes computing device 800, database 620, and input record data 630, imaging machine 650, and segmented alignment rod creation machine 660, all of which are connected to network 610. [00100] Network 610 can be, for example, a local area network (LAN), a wide area network (WAN) such as the Internet, or a combination of the two, and can include wired, wireless, or fiber optic connections.

[00101] Computing device 800 may be a hardware device that produces a customized segmented alignment rod design using segmented alignment rod creation program 640. Computing device 800 is capable of communicating with network 610, database 620, input record data 630, imaging machine 650, and segmented alignment rod creation machine 660. In some embodiments, computing device 800 may include a computer. In some embodiments, computing device 800 may include internal and external hardware components, as depicted and described in further detail with respect to Figure 12. In some embodiments, segmented alignment rod creation program 640 is implemented on a web server, which may be a management server, a web server, or any other electronic device or computing system capable of receiving and sending data. The web server can represent a computing system utilizing clustered computers and components to act as a single pool of seamless resources when accessed through a network. The web server may include internal and external hardware components, as depicted and described in further detail with respect to Figure 12.

[00102] Segmented alignment rod creation program 640 receives requests for customized segmented alignment rods. Segmented alignment rod creation program 640 can receive requests for a custom segmented alignment rod based on, inter alia, various criteria, such as patient age, sex, height, weight, spinal column imagery, and desired curvature, generate a custom segmented alignment rod design, and create a custom segmented alignment rod by communicating with segmented alignment rod creation machine 660. Segmented alignment rod creation program 640 can generally include any software capable generating a custom segmented alignment rod design and utilizing a segmented alignment rod creation machine to create the custom segmented alignment rod according to the present disclosure and communicating with database 620, input record data 630, imaging machine 650, and segmented alignment rod creation machine 660 over network 610.

[00103] Database 620 is a central storage for a set of spinal column parameters. Database 620 can be implemented using any non-volatile storage medium known in the art. For example, authentication database can be implemented with a tape library, optical library, one or more independent hard disk drives, or multiple hard disk drives in a redundant array of independent disks (RAID). In some embodiments, database 620 may contain a set of parameters related to spinal column curvature. For example, a 6 year-old boy that is 45.5” tall, weighs 44 pounds, and has a normal spinal column 501 might have an upper radius R2 and a lower radius R3 (see Figures 13A-14B) These dimensions might be used as the basis to generate a segmented alignment rod for a patient around 6-years old that is 48” tall, weighs 42 pounds, and kyphosis. Thus, database 620 may be filled with spinal column dimensions of desired spinal column curvature. Database 620 may also contain information not only related to the desired spinal column curvature, but also to the achievable spinal column curvature. For example, if, in a previous alignment using a segmented alignment rod or other spinal column alignment device, a 16 year-old patient having severe flatback was unable to achieve spinal column alignment that matched that of the desired or normal curvature for a 16 year-old of that same stature, documentation of the actual achieved curvature may instead be used as the basis for the segmented alignment rod design of a subsequent similar patient. In these instances when it is known that alignment to the normal curvature is unlikely to be achieved, segmented alignment rod creation program 640 may, instead of using the dimensions of a normal spinal column curvature, use an achieved spinal column alignment curvature. By using the achieved spinal column curvature dimensions, the segmented alignment rod may be created to impart less force and thus less discomfort on the deformed spinal column. The dimensions stored in database 620, as they relate to the spinal column, might include upper radius curvature, lower radius curvature, overall spinal column height, number of vertebrae, vertebrae dimensions, disc height, etc. for patients of all ages, heights, sex, and weights.

[00104] Input record data 630 is data inputted from a user, for example, patient specific criteria. The user may submit input record data 630, or designate the appropriate data to be provided by the database 620. The system, namely segmented alignment rod creation environment 600, is responsive to input record data 630 provided by a user or read from the database 620. As will be explained in greater detail below, segmented alignment rod creation program 640 receives input record data 630 (and/or data from database 620) and data from imaging machine 650, and generates a segmented alignment rod design, including the number of segments, the dimensions of each of the segments, and dimensions of the rod when all of the segments are fully engaged (e.g., total rod height, upper sagittal curve radius, and lower sagittal curve radius). In some embodiments, input record data 630 includes the patient’s age, height, and weight. In some embodiments, input record data 630 further includes the patient’s bone density and muscle content, how active the patient is (i.e., normal amounts of daily exercise), diet, dietary restrictions, etc.

[00105] Imaging machine 650 is any machine that is capable of taking a detailed image of a patient’s spinal column. In some embodiments, imaging machine 650 is capable of taking a detailed image using X-rays, a computed tomography (CT) scan, magnetic resonance imaging (MRI), and/or ultrasound. It should be appreciated, however, that any method suitable for taking a detailed image of a patient’s spinal column may be used. Imagine machine 650 takes a detailed image of a patient’s spinal column and sends the imagery to segmented alignment rod creation program 640.

[00106] Segmented alignment rod creation machine 660 is any machine that is capable of producing a segmented alignment rod using a segmented alignment rod design from segmented alignment rod creation program 640. In some embodiments, segmented alignment rod creation machine 660 comprises a 3D printer or other additive manufacturing machine that creates three- dimensional solid objects from a digital file (i.e., from segmented alignment rod creation program 640). In some embodiments, segmented alignment rod creation machine 660 comprises a computer numerical control (CNC) machine or other subtractive manufacturing machine that creates three-dimensional solid objects from a digital file. It should be appreciated, however, that any method suitable for creating a segmented alignment rod from a custom segmented alignment rod design may be used. Segmented alignment rod creation machine 660 receives a segmented alignment rod design (e.g., in the form of a digital file, dimensions, coordinates, etc.) from segmented alignment rod creation program 640 and manufactures the rod. In some embodiments, segmented alignment rod creation machine 660 forms the entire rod as an integrally formed part and then cuts the integrally formed rod into segments. In some embodiments, segmented alignment rod creation machine 660 forms each segment of the rod separately. Figures 19A-B show a customized segmented alignment rod 550. Examples of segmented alignment rod designs are disclosed in U.S. Patent Application No. 16/802,695 (Suddaby) and U.S. Patent No. 10,624,683 (Suddaby), which applications are hereby incorporated by reference in their entireties.

[00107] Figure 11 shows flow chart 700 depicting operational steps for generating/creating a segmented alignment rod customized for a user.

[00108] In step 702, segmented alignment rod creation program 640 receives a request for a segmented alignment rod. The request may come from input data 630 in the form of a request as well as other data, for example, and as previously described, a patient’s age, height, weight, level of exercise and activeness, muscle content, and any other relevant personal data that may be considered in the creation of a segmented alignment rod or implant. Other data that may be included in the request is a patient’s date of birth, previous or recurring health conditions, medications currently being used, or any other relevant health records.

[00109] In step 704, segmented alignment rod creation program 640 receives an image of a deformed spine (or spinal column) and processes the image. In some embodiments, segmented alignment rod creation program 640 receives an image of the patient’s deformed spine from imaging machine 650 (e.g., from a CT scan). In some embodiments, segmented alignment rod creation program 640 receives an image of the patient’s deformed spine from input data 630 (i.e., the imaging was performed by a third party and submitted along with the request in step 702). Various spinal deformities are shown in Figures 15 A, 16 A, 17A, and 18 A. In some embodiments, in step 704 or in a subsequent step, segmented alignment rod creation program 640 measures the spinal column from the image of the deformed spine and generates a representative curvature of the spinal column. Segmented alignment rod creation program 640 measures the length of each vertebra and each disc, the overall length of the spinal column (i.e., along its curvature), the height of the spinal column, and the curvature of the spinal column. The length of each vertebra and its adjacent disc is important and is used by segmented alignment rod creation program 640 to generate the length of the segment of the segmented alignment rod that is to be arranged proximate and/or adjacent that vertebra and disc. For example, using the imagery obtained from imaging machine 650, segmented alignment rod creation program 640 may use a calibrated ruler or other computer-aided measuring device to measure the various relevant dimensions of the deformed spinal column (vertebral length, disc height, curvature, spinal column height, etc.). It should be appreciated that any suitable method of measuring a spinal column may be used, for example, the methods disclosed in A comparison of three methods for measuring thoracic kyphosis: implications for clinical studies , Goh et al., Oxford Academic (2000) (https://academic.oup.eom/rheumatology/article/39/3/310/1783 798) and The growing spine: how spinal deformities influence normal spine and thoracic cage growth , Dimeglio et al. , National Center for Biotechnology Information (2011) (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3252439/), which references are incorporated herein by reference in their entireties.

[00110] As shown in Figures 15A-B, segmented alignment rod creation program 640 receives an image of deformed spinal column 511 of person P2, in this case indicating kyphosis. Spinal column 511 includes vertebrae, and discs arranged between the vertebrae, arranged having upper curve 512 and lower curve 513. As shown, kyphosis is an exaggerated, forward rounding of the back that may result in a decreased upper curve radius R12 (i.e., upper curve 512 is more substantial). Segmented rod alignment creation program 640, in step 604, measures the height of each vertebra and disc, the extent of upper curve 512 (i.e., the radius, angle, horizontal position of an apex, etc.), and the extent of lower curve 513 (i.e., the radius, angle, horizontal position of an apex, etc.). In some embodiments, segmented rod alignment creation program 640, in step 704, identifies one or more apex or marked vertebrae, namely, vertebrae 514 and 515. The apex or marked vertebrae are indicated for at least two reasons: 1) segmented alignment rod creation program 640 may include a plurality of segments to be arranged proximate the apex or marked vertebrae, which would allow for maximum displacement and is desirable for a portion of the spinal column that is set to displace the most over time (i.e., in Figure 15 A, apex vertebra 514 must be pulled to the right significantly to properly align spinal column 511); and 2) segmented alignment rod creation program 640 may indicate to the doctor that the segmented alignment rod should be connected or clamped to the apex or marked vertebrae. In some embodiments, segmented alignment rod creation program 640 may generate a representative curvature. For example, as shown in Figure 15B, a representative sagittal plane curvature 516 has been generated and shows some of the measurements taken by segmented alignment rod creation program 640, namely, upper curve radius R12, lower curve radius R1 ₃ , and spinal column height H11. The length of each vertebra and disc in spinal column 511 is also measured by segmented alignment rod creation program 640. It should be appreciated that any known system for measuring the spinal column, including vertebral and disc height, may be used (e.g., SURGIMAP® medical imaging software, MEDICREA® imaging software, etc.).

[00111] As shown in Figures 16A-B, segmented alignment rod creation program 640 receives an image of deformed spinal column 521 of person P3, in this case indicating lordosis. Spinal column 521 includes vertebrae, and discs arranged between the vertebrae, arranged having upper curve 522 and lower curve 523. As shown, lordosis is an excessive inward curve of the spine that may result in a decreased lower curve radius R2 ₃ (i.e., lower curve 523 is more substantial). Segmented rod alignment creation program 640, in step 704, measures the height of each vertebra and disc, the extent of upper curve 522 (i.e., the radius, angle, horizontal position of an apex, etc.), and the extent of lower curve 523 (i.e., the radius, angle, horizontal position of an apex, etc.). In some embodiments, segmented rod alignment creation program 640, in step 704, identifies one or more apex or marked vertebrae, for example, vertebrae 524 and 525, for reasons described previously (i.e., in Figure 16A, apex vertebra 525 must be pulled to the left significantly to properly align spinal column 521). In some embodiments, segmented alignment rod creation program 640 may generate a representative curvature, for example, a representative sagittal plane curvature 526, as shown in Figure 16B, has been generated and shows some of the measurements taken by segmented alignment rod creation program 640, namely, upper curve radius R22, lower curve radius R2 ₃ , and spinal column height H21. The length of each vertebra and disc in spinal column 521 is also measured by segmented alignment rod creation program 640

[00112] As shown in Figures 17A-B, segmented alignment rod creation program 640 receives an image of deformed spinal column 531 of person P4, in this case indicating flatback. Spinal column 531 includes vertebrae, and discs arranged between the vertebrae, arranged having upper curve 532 and lower curve 533. As shown, flatback syndrome is a condition in which the lower spine loses some of its normal curvature thereby resulting in an increased lower curve radius R ₃₃ (i.e., lower curve 533 is less substantial). Segmented rod alignment creation program 640, in step 704, measures the height of each vertebra and disc, the extent of upper curve 532 (i.e., the radius, angle, horizontal position of an apex, etc.), and the extent of lower curve 533 (i.e., the radius, angle, horizontal position of an apex, etc.). In some embodiments, segmented rod alignment creation program 640, in step 704, identifies one or more apex or marked vertebrae, for example, vertebrae 534 and 535, for reasons described previously (i.e., in Figure 17A, apex vertebra 535 must be pulled to the right significantly to properly align spinal column 531). In some embodiments, segmented alignment rod creation program 640 may generate a representative curvature, for example, a representative sagittal plane curvature 536, as shown in Figure 17B, has been generated and shows some of the measurements taken by segmented alignment rod creation program 640, namely, upper curve radius R32, lower curve radius R33, and spinal column height H31. The length of each vertebra and disc in spinal column 531 is also measured by segmented alignment rod creation program 640.

[00113] As shown in Figures 18A-B, segmented alignment rod creation program 640 receives an image of deformed spinal column 541 of person P5, in this case indicating scoliosis. Spinal column 541 includes vertebrae, and discs arranged between the vertebrae, arranged having upper curve 542 and lower curve 543. As shown, scoliosis is curvature in the spine in the frontal plane, thereby creating unwanted curvature, namely, upper curve radius R42 and lower curve radius R43, in what should be an otherwise straight arrangement. Segmented rod alignment creation program 640, in step 704, measures the height of each vertebra and disc, the extent of upper curve 542 (i.e., the radius, angle, horizontal position of an apex, etc.), and the extent of lower curve 543 (i.e., the radius, angle, horizontal position of an apex, etc.). In some embodiments, segmented rod alignment creation program 640, in step 704, identifies one or more apex or marked vertebrae, for example, vertebrae 544 and 545, for reasons described previously (i.e., in Figure 18A, apex vertebra 544 must be pulled to the right significantly to properly align spinal column 541). In some embodiments, segmented alignment rod creation program 640 may generate a representative curvature, for example, a representative frontal plane curvature 547, as shown in Figure 18B, has been generated and shows some of the measurements taken by segmented alignment rod creation program 640, namely, upper curve radius R42, lower curve radius R43, and spinal column height FLu. The length of each vertebra and disc in spinal column 541 is also measured by segmented alignment rod creation program 640. [00114] In step 706, segmented alignment rod creation program 640 generates a normal spinal curvature specific to the patient. The normal spinal curvature is generated based, in part, on the patient’s age, height, weight, etc. that was received in step 702 via input data 630. Segmented alignment rod creation program 640 communicates with database 620 and generates a normal spinal curvature for a patient having that age, height, weight, etc. For example, Figures 13A-B show a possible normal spinal curvature that segmented alignment rod creation program 640 would use to generate a normal spinal curvature for a patient. Figure 13 A shows spinal column 501 of person PI having upper curve 502, lower curve 503, and apex or marked vertebrae 504 and 505. Figure 13B shows a representative sagittal plane curvature 506 and some of the relevant dimensions to be used by segmented alignment rod creation program 640 in the creation of the segmented alignment rod, namely, upper curve radius R2, lower curve radius R3, and spinal column height Hi. Similarly, Figures 14A-B show a normal spinal curvature in the frontal plane. Figure 14A shows spinal column 501 of person PI. Figure 14B shows a representative frontal plane curvature 507 and some of the relevant dimensions to be used by segmented alignment rod creation program 640 in the creation of the segmented alignment rod, namely, spinal column height Hi. It should be appreciated that while Figure 14A shows spinal column 501 being substantially linear, some curvature in the spinal column in the frontal plane may be considered normal and thus segmented alignment rod creation program 640 could allow some curvature in the frontal pane when designing the normal curvature. As previously described, in some embodiments, segmented alignment rod creation program 640 may generate a normal spinal curvature based on an achieved spinal column curvature. For example, in a very extreme case of kyphosis, it may be nearly impossible to create a normal curvature and to attempt to force the spinal column into that normal curvature could be detrimental. As such, segmented alignment rod creation program 640 may then choose, in extreme cases (i.e., when upper curve radius R12 in Figure 15B is very small), to generate a spinal curvature that has been successfully achieved in a previous patient with a similar extreme curvature.

[00115] In step 708, segmented alignment rod creation program 640, generates a segmented alignment rod design, namely, segmented alignment rod design 550 as shown in Figures 19A-B. Segmented alignment rod creation program 640 uses the measurements of the deformed spine taken in step 704 and the normal spinal curvature created in step 706 to create a segmented alignment rod design. As previously described, segmented alignment rod creation program 640 uses the height of the vertebrae and discs in the deformed spinal column to design each segment of segmented alignment rod design 550. As shown, segmented rod design 550 comprises cranial end 551, caudal end 552, and plurality of segments 553A-M. Segments 553A- M comprise lengths 558A-M, respectively. In some embodiments, the length of each segment corresponds to the height of the intended adjacently arranged vertebra and disc (i.e., one segment is the length of one vertebra plus one disc). Since the height of vertebrae and discs differ substantially based on location within the spinal column, for example, in the cervical, thoracic, and lumbar regions, as well as from patient to patient, it is important that the measurements taken in step 704 be accurate.

[00116] In some embodiments, segmented alignment rod creation program 640 uses the height of the intended adjacently arranged vertebra and disc and an estimated growth to generate the length of each segment. Since it is known that the spinal column will increase in length as the patient grows, segmented alignment rod creation program 640 estimates the vertebral and disc height at terminal growth, or at the point where the spinal column ceases to grow. This estimation is based, at least in part, on patient data in database 620. In some embodiments, segmented alignment rod creation program 640 will retrieve the dimensions of a patient of a similar age, height, weight, vertebral and disc height, etc., determine the total growth of that patient’s spinal column length (i.e., vertebral and disc height) from that age until terminal growth, and use that total increased length/growth to create segmented alignment rod design 550. For example, segmented alignment rod creation program 640 calculates the estimated growth in terms of length, divides that length by the number of segments in segmented rod design 550, and adds that length amount to each segment. As an example, consider the following: segmented alignment rod creation program 640 designs segmented alignment rod design 550 to have five segments. Each of the segments corresponds to one vertebra and one disc totaling a height of 5 centimeters. Thus, each segment must be at least five centimeters in length. Segmented alignment rod creation program 640 further estimates that the spinal column will grow 15 centimeters in length before terminal growth is reached. As such, segmented alignment rod creation program 640 adds 3 centimeters of length to each of the five segments such that each segment is 8 inches long (15 centimeters of estimated growth divided by 5 total segments). [00117] In some embodiments, segmented alignment rod creation program 640 uses measurements of the deformed spine taken in step 704 and the normal spinal curvature created in step 706 to create a segmented alignment rod design, specifically, the exact dimensions and characteristics of each segment. Each segmented of segmented rod design 550 may have a specific shape or curvature based on where they fit in on the calculated rod shape. Additionally, the physical interactions between the individual segments is such that, when fit together, permits limited desirable motion therebetween or eliminates motion therebetween altogether. For example, a segment to be arranged in the mid-thoracic portion of the segmented alignment rod should have a greater curvature (if any) than a segment to be arranged in the lower thoracic portion. This shape change and curvature may be addressed by either creating a curved individual segment or altering the male/female engaging elements, or both. As the segmented alignment rod gradually aligns, by virtue of the segments being brought closer together, so too does the tightness of the fit between male and female engaging elements with increasing limits on movement between adjacent segments until little or no movement therebetween remains. In some cases, one or more degrees of movement between segments is desirable, even when final tautness in the segmented alignment rod is achieved (i.e., the line or cable running through the segments reaches its maximum desired tautness to pull the segments of the segmented alignment rod into full engagement). This degree of movement between segments is desirable for two reasons: 1) to allow normal movement of the spine while and after it is aligned; and, 2) to reduce stress on the spine rod interface where the alignment force is applied (i.e., such stress on a rigid rod would cause the rigid rod to fail).

[00118] Figure 20A is a perspective view of segment 562 of a segmented alignment rod. Figure 20B is a side elevational view of segment shown 562. Segment 562 is an example embodiment of a segment of segmented alignment rod assembly 550. As shown, segment 562 comprises a generally ovular cross-section; although it should be appreciated that any suitable geometry may be used, such as, for example, circular, ellipsoidal, square, rectangular, triangular, trapezoidal, polynomial, etc. Segment 562 comprises body 564, end 566, end 568, male engaging element 570, and female engaging element 572.

[00119] Male engaging element 570 is connected to end 568 and tapers therefrom. Male engaging element 570 is operatively arranged to engage the female engaging element of the adjacent segment. Male engaging element 570 comprises axial length L and taper angle a. By varying length L and angle a, the angle of movement between segments can also be defined. For example as angle a increases, the movement and/or flexion between segment 562 and the adjacent segment connected to end 568 also increases. As angle a decreases or becomes “steeper,” the movement and/or flexion between segment 562 and the adjacent segment connected to end 568 decreases. Similarly, as length L decreases, less surface area of male engaging element 570 is in contact with the surface area of the female engaging element of the adjacent segment, and thus movement and/or flexion between the segment 562 and the adjacent segment connected to end 568 increases. As length L increases, more surface area of male engaging element 570 can contact with the surface area of the female engaging element of the adjacent segment, and thus movement and/or flexion between the segment 562 and the adjacent segment connected to end 568 decreases.

[00120] Female engaging element 572 is connected to end 566 and tapers therefrom within body 564. Female engaging element 572 is operatively arranged to engage the male engaging element of the adjacent segment. Female engaging element 572 comprises taper angle b. It should be appreciated that taper angle a and taper angle b do not necessarily need to be the same, but they can be. segmented alignment rod creation program 640 may design segmented alignment rod design 550 to have varying degrees of movement and/or flexion at different sections of the rod. However, taper angles of engageable male and female engaging members should be the same for proper engagement and alignment. In some embodiments, taper angle b is equal to the male engaging member taper angle of the adjacent segment. In some embodiments, taper angle b is not equal to the male engaging member taper angle of the adjacent segment. [00121] As previously described, body 564 may comprise a curvature. As shown, body 564 comprises inner radius Ri and outer radius Ro. Such curvature and radii corresponds to the desired final curvature of the segmented alignment rod 550 and thus the spinal column.

[00122] In some embodiments, the tapered male engaging element or the female tapered male engaging element may be shaped or designed such that it is the engaging elements that form the curvature of segmented alignment rod 550. Figure 21 is a perspective view of segment 582 of a segmented alignment rod. Figure 22 is a side elevational view of segment 582 engaged with adjacent segment 582A of the segmented alignment rod. Segments 582 and 582A are example embodiments of segments of segmented alignment rod assembly 550. As shown, segment 582 comprises a generally square cross-section; although it should be appreciated that any suitable geometry may be used, such as, for example, ovular, ellipsoidal, rectangular, triangular, trapezoidal, circular, polynomial, etc. Segment 582 comprises body 584, end 586, end 588, male engaging element 590, and female engaging element 592.

[00123] Male engaging element 590 is connected to end 588 and tapers therefrom. Male engaging element 590 is operatively arranged to engage the female engaging element of the adjacent segment, for example, segment 582A. Male engaging element 590 comprises an axial length and a taper angle, as previously described with respect to Figures 20A-B. Male engaging element 590 is also arranged at an angle with respect to body 584. Specifically, a centerline of male engaging element 590 is arranged at angle g with respect to a centerline of body 584. This angled segment design allows the junction or the engagement of segments to dictate the curvature of segmented alignment rod design 550. This is best shown in Figure 22, wherein segment 582 is fully engaged with segment 582A. Body 584 of segment 582 and the body of segment 582A are substantially linear. However, the shape of male engaging element 590, namely, male engaging element 590 be arranged at angle g with respect to body 584, results in a curved or angled segmented alignment rod (i.e., when fully engaged, substantially linear segments 582 and 582A are arranged at an angle or form a curvature).

[00124] Female engaging element 592 is connected to end 586 and tapers therefrom within body 584. Female engaging element 582 is operatively arranged to engage the male engaging element of the adjacent segment. In some embodiments, female engaging member 592 is arranged at an angle or curvature from a centerline of body 584 such that the shape of female engaging member 592, when engaged with the male engaging member of the adjacent segment, forms the curvature of segmented alignment rod 550. In some embodiments, both male engaging member 590 and female engaging member 592 are arranged at angles from a centerline of body 584

[00125] Segmented alignment rod design 550 further comprises upper curve radius 554, lower curve radius 555, and height 556. As previously described, segmented alignment rod creation program 640 designs segmented alignment rod design 550 according to a normal spinal column curvature or an achievable spinal column curvature. In some embodiments, segmented alignment rod creation program 640 designs segmented alignment rod design 550 to have upper curve radius 554 equal to upper curve radius R2, lower curve radius 555 equal to lower curve radius R3, and height 556 equal to height Hi, as in the dimensions of normal person PI as shown in Figures 13A-14B. It should be appreciated that Figures 19A-B show segmented alignment rod design 550 with segments 553A-M fully engaged with each other (i.e., segmented alignment rod design 550 is in its final shape after having been fully tensioned by a tensioning mechanism). The means engaging segments 553A-M are known in the art, and may include tapered portions, tangs, or any other suitable engagement means. Segmented alignment rod design 550 may further include aperture 557. In some embodiments, aperture 557 extends completely through segmented alignment rod 550 (i.e., through each of segments 553A-M). In some embodiments, aperture 557 extends at least partially through segmented alignment rod 550. A tensioning device may gradually pull the separated segments 553A-M into engagement, which in turn straightens the deformed spinal column. It should be appreciated that the various segments of the present disclosure may be hollow or may be solid having a through-bore through which the tensioning member(s) extends. It should also be appreciated that the various segments of the present disclosure may include a plurality of through-bores through which a plurality of tensioning members extend. In some embodiments, segmented alignment rod creation program 640 indicates one or more of segments 553A-M as being a marked segment. The indicated marked segment is intended to be clamped to a vertebra, for example, a marked or apex vertebra. In some embodiments, the marked segments are to be created with an attachment point, to be attached to a clamp or screw. In some embodiments, the marked segments have a marking or color indicator. It should be appreciated that any suitable means for indicating that a segment is to be a marked vertebra may be used. Various segments engagement means and tensioning methods have been disclosed in U.S. Patent Application No. 16/802,695 (Suddaby) and U.S. Patent No. 10,624,683 (Suddaby), which references are incorporated by reference herein in their entireties.

[00126] In step 710, segmented alignment rod creation program 640 sends segmented alignment rod design 550 to segmented alignment rod creation machine 660 to be manufactured. As previously described, segmented alignment rod creation machine 660 may be a 3D printer or other additive manufacturing machine that creates three-dimensional solid objects from a digital file (i.e., from segmented alignment rod creation program 640). In some embodiments, segmented alignment rod creation machine 660 comprises a CNC machine or other subtractive manufacturing machine that creates three-dimensional solid objects from a digital file. It should be appreciated, however, that any method suitable for creating a segmented alignment rod from a custom segmented alignment rod design may be used. Segmented alignment rod creation machine 660 receives a segmented alignment rod design (e.g., in the form of a digital file, dimensions, coordinates, etc.) from segmented alignment rod creation program 640 and manufactures the rod. In some embodiments, segmented alignment rod creation machine 660 forms the entire rod as an integrally formed part and then cuts the integrally formed rod into segments. In some embodiments, segmented alignment rod creation machine 660 forms each segment of the rod separately. It should be appreciated that the segmented alignment rod that is created by segmented alignment rod creation program 640 is arranged to be implanted into a patient with the segmented thereof in a separated arrangement, and overtime, the segments are pulled together into engagement with each other to form a semi-rigid rod. By semi-rigid, it is meant that the segmented alignment rod will, when the segments thereof are fully engaged, allow substantial degrees of normal movement by the patient. Thus, the segmented alignment rod of the present disclosure differs substantially form a solid alignment rod, which permits no normal movement by the patient. Additionally, the segmented alignment rod of the present disclosure is flexible upon implantation and thus may be easier to implant than a solid rod. It should also be appreciated that the segmented alignment rod of the present invention can be altered in an operating room at the time of surgery (e.g., if the segmented rod must be shortened, a doctor may simply remove segments therefrom), whereas solid rods do not have such capabilities (i.e., solid metal rods are manufactured off site and cannot be altered at the time of surgery).

[00127] Figure 12 is a block diagram of internal and external components of computing device 800, which is representative of the computing device of Figure 10, in accordance with an embodiment of the present disclosure. It should be appreciated that Figure 12 provides only an illustration of one implementation and does not imply any limitations with regard to the environments in which different embodiments may be implemented. In general, the components illustrated in Figure 12 are representative of any electronic device capable of executing machine- readable program instructions. Examples of computer systems, environments, and/or configurations that may be represented by the components illustrated in Figure 12 include, but are not limited to, personal computer systems, server computer systems, thin clients, thick clients, laptop computer systems, tablet computer systems, cellular telephones (i.e., smart phones), multiprocessor systems, microprocessor-based systems, network PCs, minicomputer systems, mainframe computer systems, and distributed cloud computing environments that include any of the above systems or devices.

[00128] Computing device 800 includes communications fabric 802, which provides for communications between one or more processing units 804, memory 806, persistent storage 808, communications unit 810, and one or more input/output (I/O) interfaces 812. Communications fabric 802 can be implemented with any architecture designed for passing data and/or control information between processors (such as microprocessors, communications and network processors, etc.), system memory, peripheral devices, and any other hardware components within a system. For example, communications fabric 802 can be implemented with one or more buses. [00129] Memory 806 and persistent storage 808 are computer readable storage media. In this embodiment, memory 806 includes random access memory (RAM) 816 and cache memory 818. In general, memory 806 can include any suitable volatile or non-volatile computer readable storage media. Software is stored in persistent storage 808 for execution and/or access by one or more of the respective processors 804 via one or more memories of memory 806.

[00130] Persistent storage 808 may include, for example, a plurality of magnetic hard disk drives. Alternatively, or in addition to magnetic hard disk drives, persistent storage 808 can include one or more solid state hard drives, semiconductor storage devices, read-only memories (ROM), erasable programmable read-only memories (EPROM), flash memories, or any other computer readable storage media that is capable of storing program instructions or digital information.

[00131] The media used by persistent storage 808 can also be removable. For example, a removable hard drive can be used for persistent storage 808. Other examples include optical and magnetic disks, thumb drives, and smart cards that are inserted into a drive for transfer onto another computer readable storage medium that is also part of persistent storage 808.

[00132] Communications unit 810 provides for communications with other computer systems or devices via a network. In this exemplary embodiment, communications unit 810 includes network adapters or interfaces such as a TCP/IP adapter cards, wireless Wi-Fi interface cards, or 3G or 4G wireless interface cards or other wired or wireless communications links. The network can comprise, for example, copper wires, optical fibers, wireless transmission, routers, firewalls, switches, gateway computers and/or edge servers. Software and data used to practice embodiments of the present disclosure can be downloaded to computing device 800 through communications unit 810 (i.e., via the Internet, a local area network, or other wide area network). From communications unit 810, the software and data can be loaded onto persistent storage 808. [00133] One or more I/O interfaces 812 allow for input and output of data with other devices that may be connected to computing device 800. For example, I/O interface 812 can provide a connection to one or more external devices 820 such as a keyboard, computer mouse, touch screen, virtual keyboard, touch pad, pointing device, or other human interface devices. External devices 820 can also include portable computer readable storage media such as, for example, thumb drives, portable optical or magnetic disks, and memory cards. EO interface 812 also connects to display 822.

[00134] Display 822 provides a mechanism to display data to a user and can be, for example, a computer monitor. Display 822 can also be an incorporated display and may function as a touch screen, such as a built-in display of a tablet computer.

[00135] The present disclosure may be a system, a method, and/or a computer program product. The computer program product may include a computer readable storage medium (or media) having computer readable program instructions thereon for causing a processor to carry out aspects of the present disclosure.

[00136] The computer readable storage medium can be a tangible device that can retain and store instructions for use by an instruction execution device. The computer readable storage medium may be, for example, but is not limited to, an electronic storage device, a magnetic storage device, an optical storage device, an electromagnetic storage device, a semiconductor storage device, or any suitable combination of the foregoing. A non-exhaustive list of more specific examples of the computer readable storage medium includes the following: a portable computer diskette, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or Flash memory), a static random access memory (SRAM), a portable compact disc read-only memory (CD-ROM), a digital versatile disk (DVD), a memory stick, a floppy disk, a mechanically encoded device such as punch-cards or raised structures in a groove having instructions recorded thereon, and any suitable combination of the foregoing. A computer readable storage medium, as used herein, is not to be construed as being transitory signals per se, such as radio waves or other freely propagating electromagnetic waves, electromagnetic waves propagating through a waveguide or other transmission media (e.g., light pulses passing through a fiber-optic cable), or electrical signals transmitted through a wire.

[00137] Computer readable program instructions described herein can be downloaded to respective computing/processing devices from a computer readable storage medium or to an external computer or external storage device via a network, for example, the Internet, a local area network, a wide area network and/or a wireless network. The network may comprise copper transmission cables, optical transmission fibers, wireless transmission, routers, firewalls, switches, gateway computers and/or edge servers. A network adapter card or network interface in each computing/processing device receives computer readable program instructions from the network and forwards the computer readable program instructions for storage in a computer readable storage medium within the respective computing/processing device.

[00138] Computer readable program instructions for carrying out operations of the present disclosure may be assembler instructions, instruction-set-architecture (ISA) instructions, machine instructions, machine dependent instructions, microcode, firmware instructions, state-setting data, or either source code or object code written in any combination of one or more programming languages, including an object oriented programming language such as Smalltalk, C++ or the like, and conventional procedural programming languages, such as the “C” programming language or similar programming languages. The computer readable program instructions may execute entirely on the user’s computer, partly on the user’s computer, as a stand-alone software package, partly on the user’s computer and partly on a remote computer or entirely on the remote computer or server. In the latter scenario, the remote computer may be connected to the user’s computer through any type of network, including a local area network (LAN) or a wide area network (WAN), or the connection may be made to an external computer (for example, through the Internet using an Internet Service Provider). In some embodiments, electronic circuitry including, for example, programmable logic circuitry, field-programmable gate arrays (FPGA), or programmable logic arrays (PLA) may execute the computer readable program instructions by utilizing state information of the computer readable program instructions to personalize the electronic circuitry, in order to perform aspects of the present disclosure. [00139] Aspects of the present disclosure are described herein with reference to flowchart illustrations and/or block diagrams of methods, apparatus (systems), and computer program products according to embodiments of the disclosure. It will be understood that each block of the flowchart illustrations and/or block diagrams, and combinations of blocks in the flowchart illustrations and/or block diagrams, can be implemented by computer readable program instructions.

[00140] These computer readable program instructions may be provided to a processor of a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine, such that the instructions, which execute via the processor of the computer or other programmable data processing apparatus, create means for implementing the functions/acts specified in the flowchart and/or block diagram block or blocks. These computer readable program instructions may also be stored in a computer readable storage medium that can direct a computer, a programmable data processing apparatus, and/or other devices to function in a particular manner, such that the computer readable storage medium having instructions stored therein comprises an article of manufacture including instructions which implement aspects of the function/act specified in the flowchart and/or block diagram block or blocks. [00141] The computer readable program instructions may also be loaded onto a computer, other programmable data processing apparatus, or other device to cause a series of operational steps to be performed on the computer, other programmable apparatus or other device to produce a computer implemented process, such that the instructions which execute on the computer, other programmable apparatus, or other device implement the functions/acts specified in the flowchart and/or block diagram block or blocks.

[00142] The flowchart and block diagrams in the Figures illustrate the architecture, functionality, and operation of possible implementations of systems, methods, and computer program products according to various embodiments of the present disclosure. In this regard, each block in the flowchart or block diagrams may represent a module, segment, or portion of instructions, which comprises one or more executable instructions for implementing the specified logical function(s). In some alternative implementations, the functions noted in the block may occur out of the order noted in the figures. For example, two blocks shown in succession may, in fact, be executed substantially concurrently, or the blocks may sometimes be executed in the reverse order, depending upon the functionality involved. It will also be noted that each block of the block diagrams and/or flowchart illustration, and combinations of blocks in the block diagrams and/or flowchart illustration, can be implemented by special purpose hardware-based systems that perform the specified functions or acts or carry out combinations of special purpose hardware and computer instructions.

[00143] It will be appreciated that various aspects of the disclosure above and other features and functions, or alternatives thereof, may be desirably combined into many other different systems or applications. Various presently unforeseen or unanticipated alternatives, modifications, variations, or improvements therein may be subsequently made by those skilled in the art which are also intended to be encompassed by the following claims.

REFERENCE NUMERALS

1 Spinal column 41 Channel(s)

2 Upper curve 42 Plate 3 Lower curve 46 Teeth

4 Brace 48 Connector

5 Brace 35 50 Tensioning member

10 Segmented rod assembly 51 Line

12 Sheath 52 End 20 Rod 54 End 22A Segment 56 Teeth 22B Segment 40 60 Anchor 22C Segment 62 Anchor 24A Body 64 Anchor 24B Body 80 Spine 24C Body 82 Cranial vertebra 26A End 45 84 Caudal vertebra 26B End 86 Apex vertebra 26C End 90 Cranium 28A End 92 Coccyx 30A Tang(s) 110 Segmented rod assembly 30B Tang(s) 50 112 Sheath 30C Tang(s) 120 Rod assembly 31A Channel(s) 122 A Segment 31B Channel(s) 122B Segment 31C Channel(s) 122C Segment 32 Segment 55 122D Segment 34 Body 122E Segment 36 End 122F Segment 38 End 122G Segment 122H Segment 131E Channel(s)

1221 Segment 132 Segment

122J Segment 134 Body

122K Segment 136 End 122L Segment 35 138 End

122M Segment 141 Channel(s)

122N Segment 142 Plate

124A Body 150A Tensioning member

124B Body 150B Tensioning member 124C Body 40 152 A End

124D Body 152B End

124E Body 154 A End

126A End 154B End

126B End 200 Biasing element 126C End 45 300 Biasing element

126D End 400 Transducer

126E End 410 Control

128A End 501 Spinal column

128B End 502 Upper curve 128C End 50 503 Lower curve

128D End 504 Apex vertebra

128E End 505 Apex vertebra

130A Tang(s) 506 Representative sagittal (plane)

130B Tang(s) curvature 130C Tang(s) 55 507 Representative frontal (plane)

130D Tang(s) curvature

130E Tang(s) 511 Spinal column

131B Channel(s) 512 Upper curve

131C Channel(s) 513 Lower curve 131D Channel(s) 60 514 Apex vertebra 515 Apex vertebra 553C Segment

516 Representative sagittal (plane) 553D Segment curvature 553E Segment

521 Spinal column 553F Segment 522 Upper curve 35 553G Segment

523 Lower curve 553H Segment

524 Apex vertebra 5531 Segment

525 Apex vertebra 553J Segment

526 Representative sagittal (plane) 553K Segment curvature 40 553L Segment

531 Spinal column 553M Segment

532 Upper curve 554 Upper curve radius

533 Lower curve 555 Lower curve radius

534 Marked or apex vertebra 556 Height 535 Marked or apex vertebra 45 557 Aperture

536 Representative sagittal (plane) 558A Length curvature 558B Length

541 Spinal column 558C Length

542 Upper curve 558D Length 543 Lower curve 50 558E Length

544 Marked or apex vertebra 558F Length

545 Marked or apex vertebra 558G Length

546 Representative frontal (plane) 558H Length curvature 5581 Length 550 Segmented alignment rod design 55 558J Length

(segmented alignment rod) 558K Length

551 Cranial end 558L Length

552 Caudal end 558M Length

553A Segment 562 Segment 553B Segment 60 564 Body 566 End 15 806 Memory

568 End 808 Persistent storage

570 Engaging element 810 Communications unit

572 Engaging element 812 Input/output (I/O) interfaces 582 Segment 816 Random access memory (RAM)

582A Segment 20 818 Cache memory

584 Body 820 External device(s)

586 End 822 Display

588 End ADI Axial direction 590 Engaging element AD2 Axial direction

592 Engaging element 25 F Force

600 Segmented alignment rod Hi Spinal column height creation environment Hu Spinal column height 610 Network H21 Spinal column height

620 Database H31 Spinal column height

630 Input record data 30 H41 Spinal column height

640 Segmented alignment rod L Length creation program P Person 650 Imaging machine PI Person

660 Segmented alignment rod P2 Person creation machine 35 P3 Person 700 Flow chart P4 Person

702 Step P5 Person

704 Step R2 Upper curve radius

706 Step R3 Lower curve radius

708 Step 40 R12 Upper curve radius

710 Step Rl3 Lower curve radius

800 Computing device R22 Upper curve radius

802 Communications fabric R23 Lower curve radius

804 Processing units R32 Upper curve radius R33 Lower curve radius

R42 Upper curve radius

R43 Lower curve radius

Ri Radius Ro Radius a Angle b Angle

Y Angle