Device and related method for reducing scoliosis deformity

Abstract

A device and related method that utilizes magnetic torques and / or forces to reduce scoliosis deformity. By torquing and / or forcing a scoliotic spine toward a non-scoliotic shape for enough time and / or repetitions, a scoliosis deformity can be reduced, due to reforming and / or remodeling of body tissues.

Description

DEVICE AND RELATED METHOD FOR REDUCING SCOLIOSIS DEFORMITYCross Reference to Related Application

[0001] This application claims priority to USSN 63 / 623,340, filed January 22, 2024, in accordance with relevant portions of 35 U.S.C.§119 and 35 U.S.C. §120. The entire contents of this document is herein incorporated by reference.Technical Field

[0002] This application relates to a method and related apparatus for reducing spinal scoliosis deformities of a subject.Technical Background

[0003] Spinal scoliosis is an orthopedic condition that is characterized by an abnormal curvature of the spine, with varying degrees of lateral curvature, lordosis, kyphosis, and rotation. The vertebral column is composed of vertebra, discs, ligaments, tendons, and muscles. The function of the vertebral column is to provide both mobility and stability of the torso. Mobility includes rotation, lateral bending, extension and flexion. Scoliotic curvature is associated with pathological changes in the vertebra and / or related structures. Vertebral bodies can become wedge-shaped, while pedicles and lamina can become shorter and thinner on the concave aspect of the spine. Apart from the obvious physical deformity, there are also potential cardiopulmonary issues that may develop, particularly as curvature increases and rotation progresses to the extent of causing the chest cavity to narrow. In severe deformities, this may lead to premature death caused by respiratory disease and pneumonia.

[0004] There are presently over three million cases in the United States reported per year. While this condition cannot actually be cured at the time of writing, there are a number of known types of surgeries for scoliosis treatment, the most common of these being spinal fusion and spinal tethering.

[0005] Spinal fusion employs one or more metal rods, each of which are secured to the spine using metal screws, either posteriorly using pedicle screws, or anteriorly using vertebral body screws.

[0006] While there are positive effects of spinal fusion, which can include reduction and stabilization of scoliosis deformity, there are also a number of negative effects that are created by thislatter procedure. These negative effects can include a reduction of spinal mobility, as well as the risks and hardships of a highly invasive surgery, including that of a relatively long and difficult recovery. In addition, there is a risk of hardware breakage, an increased risk of other spinal diseases developing, and a risk of under-correction of the scoliosis deformity.

[0007] Although spinal fusion is useful, this technique still leaves room for improvement. In this regard, spinal fusion is generally regarded as a “last resort” surgery option.

[0008] Given the above-noted issues and risks, and to create an alternative to spinal fusion for some scoliosis patients, spinal tethering was invented in or about 2010, with FDA approval being provided in 2019. The main sub types of spinal tethering are Vertebral Body Tethering (VBT), Anterior Scoliosis Correction (ASC), and Posterior Vertebral Pedicular Tethering (PVPT).

[0009] Generally, spinal tethering uses at least one rope-like tether, which is connected to the side of the spine using vertebral body screws, with the exception of posterior tethering in which the tether is connected to pedicle screws. The tether can be tensioned to reduce the scoliosis deformity. The tether can also utilize any remaining growth of the spine (for young patients) and slow the growth on one side of the spine, which can result in an overall reduction of the scoliosis deformity.

[0010] There are a number of positive effects from spinal tethering, which can include reduction and stabilization of a scoliosis deformity, as well as the retention of more spinal mobility for the patient than that which can be obtained with a comparable spinal fusion, and a less invasive surgery than with a comparable spinal fusion. However, there are also a number of negative effects, which can include the potential of tether breakage, and an overall reduction of spinal mobility. Moreover, spinal tethering is still a relatively highly invasive surgery requiring a relatively long and difficult recovery. There is also a risk of over-correction or under-correction of the scoliosis deformity.

[0011] The bottom line is that although spinal tethering is useful, and often preferred over spinal fusion, this latter technique still leaves room for improvement.

[0012] When surgery is recommended to scoliosis patients, the current options can feel unappealing. Summarily, although having treatment options is better than not having any options at all,each of the currently available procedures are invasive, which may lead to uncertain outcomes.

[0013] In this regard, there is a continuing and pervasive need to devise a procedure that is less invasive and / or more effective than either spinal fusion or spinal tethering. This procedure would ideally allow patients to retain full spinal mobility, and / or employ smaller surgical incisions and / or fewer surgical incisions, and / or minimally interfere with the life of a patient, while producing an excellent result.

[0014] There is a further need to create an effective and cumulative treatment for scoliotic patients that is minimally invasive, in which the treatment, if needed, can be repeated a number of times to incrementally correct the deformity.Brief Description

[0015] The herein described apparatus and related methods are intended to improve upon and / or resolve one or more of the above-described needs. According to the invention, a novel apparatus and method employs magnetic torques and / or forces to reduce scoliosis deformity, by torquing and / or forcing a scoliotic spine toward a non-scoliotic shape.

[0016] Advantageously, torquing and / or forcing a scoliotic spine toward a non-scoliotic shape, for a sufficient amount of time and / or repetitions, causes tissues of the body to plastically change and / or remodel, including, but not limited to ligaments, tendons, muscles, and bones. The reformed tissues may be capable of retaining the spine in a new shape that more closely resembles that of a non-scoliotic spine. The amount of scoliosis deformity correction from a single therapy session may be marginal at first, but the accumulation of corrections from repeated therapy sessions using the herein described apparatus and related methods can become significant.

[0017] Therefore and according to at least one aspect, there is provided a method for reducing scoliosis deformity, the method comprising the steps of implanting one or more vertebral implants within one or more vertebrae of a scoliotic spine; and generating a magnetic field sufficient to induce torque(s) on the one or more vertebral implants. According to at least one version, the generated magnetic field does not induce a substantial net translational force on the one or more vertebral implants, wherein the one or more vertebral implants can be made from a ferromagnetic material.

[0018] According to at least one embodiment, the at least one vertebral implant is a bolt, such as a threaded bolt. In at least one version, the bolt can be defined by a taper. In one or more versions, a portion of at least one implanted vertebral implant protrudes outwardly from a vertebra. The one or more vertebral implants can be disposed such that a major axis of the vertebral implant is substantially parallel with a lateral axis of the vertebra into which the implant is implanted.

[0019] In accordance with the herein described method, a patient can be positioned within a finite region of the magnetic field. In at least one version, the magnetic torques and / or forces can be applied to one or more of the vertebral implants in a patient over more than one session without further surgery, following implantation of the one or more vertebral implants.

[0020] According to another aspect, there is provided an apparatus for reducing scoliotic deformities, the apparatus comprising a housing; and a magnetic field generator partially or fully disposed within the housing, the magnetic field generator being sized and configured for generating a magnetic field in relation to the patient such that the magnetic field will induce torques upon one or more vertebral implants implanted in one or more vertebrae of the patient.

[0021] In at least one version, the magnetic field generator comprises an electromagnet. According to at least one embodiment, the magnetic field generator is a solenoid. According to yet another version, the magnetic field generator is a Helmholtz coil. In any event, the magnetic field generator is designed to produce a substantially uniform magnetic field within a finite region in and / or around the patient.

[0022] In one or more embodiments, the one or more vertebral implants are partially or wholly made of a ferromagnetic material. According to at least one version, at least one of the one or more vertebral implants are bolts. The apparatus may be configured to apply a torque on at least one vertebral implant without simultaneously applying a substantial net translational force thereon.

[0023] In brief, the herein described apparatus includes least two (2) components, namely: at least one (1) surgically implanted vertebral implant, which may contain ferromagnetic material (for example, iron or some steels), and which is implanted into at least one (1) vertebra of a patient, and at least one (1) magnetic field generator external to the body of a patient that is capable of generating amagnetic field capable of creating substantial torque and / or force on at least one vertebral implant. Other aspects are directed to methods, including but not limited to therapy methods and surgical methods, employing the herein described apparatus or variants thereof.

[0024] The possible benefits and advantages of the herein described apparatus and related methods, when compared to spinal fusion or spinal tethering, include the following: i) a patient can retain more spinal mobility; ii) the surgery can be less invasive and / or can use smaller surgical incisions, iii) there can be smaller implant protrusions from the vertebrae; iv) there can be a reduced risk of over-correction and / or under-correction, because the magnitudes and / or directions of torques and / or forces on the implanted vertebral implants can be controllable post operation; and v) there can be a reduced risk of hardware breakage.

[0025] Advantageously, once the vertebral implants have been implanted, subsequent treatments can be done without further surgeries, in the form of therapy sessions employing magnetic torques and / or forces.

[0026] These and other features and advantages will be readily apparent from the following DetailedDescri ption, as read in conjunction with the accompanying drawings.Brief Description of the Drawings

[0027] FIG. 1(a) schematically depicts a vertebral implant, which may contain ferromagnetic material, as disposed within a uniform magnetic field;

[0028] FIG. 1(b) schematically depicts the vertebral implant and theoretical uniform magnetic field of FIG. 1(a), but with the vertebral implant being disposed in a rotated position;

[0029] FIG. 2(a) is a perspective view of a vertebral implant in accordance with an embodiment;

[0030] FIG. 2(b) is a side elevational view of the vertebral implant of FIG. 2(a);

[0031] FIG. 3(a) is a perspective view of a vertebral implant in accordance with anotherembodiment;

[0032] FIG. 3(b) is a side elevational view of the vertebral implant of FIG. 3(a);

[0033] FIG. 4(a) is a perspective view of a single vertebra having a vertebral implant disposed therein in accordance with an embodiment, the vertebra being shown translucently for clarity;

[0034] FIG. 4(b) is a top plan view of the single vertebra and vertebral implant of FIG. 4(a); the vertebra being shown translucently for purposes of clarity;

[0035] FIG. 4(c) is a front elevational view of the single vertebra and vertebral implant of FIGS. 4(a) and 4(b), the vertebra being shown translucently for purposes of clarity;

[0036] FIG. 5 is a front elevational view of a single vertebra having a vertebral implant disposed in accordance with another embodiment, the vertebra being shown translucently for purposes of clarity;

[0037] FIG. 6 is a top plan view of a single vertebra having a vertebral implant disposed therein in accordance with another embodiment, the vertebra being shown translucently for purposes of clarity;

[0038] FIG. 7 is a front elevational view of a single vertebra having a vertebral implant disposed therein in accordance with yet another embodiment, the vertebra being shown translucently for purposes of clarity;

[0039] FIG. 8(a) is a perspective view of a single vertebra having multiple vertebral implants disposed therein in accordance with another embodiment, the vertebra being shown translucently for purposes of clarity;

[0040] FIG. 8(b) is a top plan view of the single vertebra and multiple vertebral implants disposed therein of FIG. 8(a), the vertebra being shown translucently for purposes of clarity;

[0041] FIG. 9(a) is a front pictorial view of a spine having a plurality of vertebral implants implanted within a plurality of vertebrae, the vertebrae and body being shown translucently for purposes of clarity;

[0042] FIG. 9(b) is the side facing view of the spine of FIG. 9(a), the vertebrae and body being shown translucently for purposes of clarity;

[0043] FIG. 10(a) is a schematic view of a single vertebra having an implanted vertebral implant disposed in relation to a theoretical uniform magnetic field and in accordance with one or more embodiment;

[0044] FIG. 10(b) is a schematic view of the single vertebra and implanted vertebral implant of FIG. 10(a), as angularly disposed within the theoretical uniform magnetic field;

[0045] FIG. 10(c) is another schematic view of the single vertebra and implanted vertebral implant of FIGS. 10(a) and 10(b), as orthogonally disposed within the uniform magnetic field;

[0046] FIG. 11(a) is a schematic view of a single vertebra having an implanted vertebral implant disposed in relation to a theoretical uniform magnetic field and in accordance with one or more embodiments;

[0047] FIG. 11(b) is a schematic view of the single vertebra and implanted vertebral implant of FIG. 11(a), as angularly disposed within the theoretical uniform magnetic field;

[0048] FIG. 11(c) is another schematic view of the single vertebra and implanted vertebral implant of FIGS. 11(a) and 11(b), as orthogonally disposed within the uniform magnetic field;

[0049] FIG. 12(a) is a front elevational view of a spine schematically depicting one possible combination of placements of a plurality of vertebral implants in accordance with an embodiment;

[0050] FIG. 12(b) is the frontal elevational schematic view of FIG. 12(a), further including a generated theoretical uniform magnetic field, and including a representation of resultant torquescreated on the vertebral implants, and therefore also on the spine;

[0051] FIG. 12(c) is the frontal elevational schematic view of FIG. 12(b), which could be interpreted as any of the following: i) a generated magnetic field of increased intensity, and / or ii) the same magnetic field intensity, but with enough time having passed for the spine to deform via creep and / or stress relaxation, and / or iii) the correction of the scoliotic deformity due to repeated therapy sessions with magnetic torques and / or forces;

[0052] FIG. 12(d) is an enlarged schematic front elevational view of a portion of a spine, in which some of the vertebral implants are angularly disposed relative to the vertebrae, in accordance with an embodiment;

[0053] FIG. 13(a) is a perspective view of a magnetic field generator in accordance with an embodiment;

[0054] FIG. 13(b) is an enlarged end view of the magnetic field generator of FIG. 13(a);

[0055] FIG. 13(c) is a side elevational view of the magnetic field generator of FIGS. 13(a) and 13(b);

[0056] FIG. 13(d) is the side elevational view of the magnetic field generator of FIGS. 13(a) - 13(c), further schematically depicting a generated magnetic field;

[0057] FIG. 13(e) is the top elevational view of the magnetic field generator of FIGS. 13(a) - 13(d), including a schematic depiction of a generated magnetic field;

[0058] FIG. 13(f) is an end facing view of the magnetic field generator of FIGS. 13(a) - 13(e), including a schematic depiction of a generated magnetic field;

[0059] FIG. 14(a) is a perspective view of another magnetic field generator in accordance with aspects of the invention;

[0060] FIG. 14(b) schematically depicts an example of a patient as positioned relative to the magnetic field generator of FIG. 14(a);

[0061] FIG. 14(c) depicts a side elevational view of the magnetic field generator of FIGS. 14(a) and 14(b);

[0062] FIG. 14(d) depicts a top plan view of the magnetic field generator of FIGS. 14(a) - 14(c);

[0063] FIG. 14(e) is a side view of the magnetic field generator of FIGS. 14(a) - 14(d);

[0064] FIG. 14(f) is a side elevational view of the magnetic field generator of FIGS. 14(a) -14(e), including a schematic illustration of a generated magnetic field in accordance with one or more embodiments;

[0065] FIG. 14(g) is the top elevational view of the magnetic field generator of FIGS. 14(a) - 14(f), including a schematic illustration of the generated magnetic field;

[0066] FIG. 14(h) is the end facing view of the magnetic field generator of FIGS. 14(a) - 14(g), including a schematic illustration of the generated magnetic field;

[0067] FIG. 15(a) is a perspective view of a magnetic field generator in accordance with another embodiment;

[0068] FIG. 15(b) schematically depicts an example of a patient as positioned relative to the magnetic field generator of FIG. 15(a);

[0069] FIG. 15(c) depicts a depicts a side elevational view of the magnetic field generator of FIGS. 15(a) and 15(b);

[0070] FIG. 15(d) depicts a top plan view of the magnetic field generator of FIGS. 15(a) -15(c);

[0071] FIG. 15(e) is an end facing view of the magnetic field generator of FIGS. 15(a) - 15(d);

[0072] FIG. 15(f) is a side elevational view of the magnetic field generator of FIGS. 15(a) - 15(e), including a schematic illustration of a generated magnetic field in accordance with one or more embodiments;

[0073] FIG. 15(g) is the top plan view of the magnetic field generator of FIGS. 15(a) - 15(f), including the schematic illustration of the generated magnetic field;

[0074] FIG. 15(h) is the end facing view of the magnetic field generator of FIGS. 15(a) - 15(g), including a schematic illustration of the generated magnetic field;

[0075] FIG. 16(a) is a perspective view of a magnetic field generator in accordance with another embodiment;

[0076] FIG. 16(b) schematically depicts an example of a patient as positioned relative to the magnetic field generator of FIG. 16(a);

[0077] FIG. 16(c) depicts a depicts a top plan view of the magnetic field generator of FIGS. 16(a) and 16(b);

[0078] FIG. 16(d) depicts a side elevational view of the magnetic field generator of FIGS. 16(a) - 16(c);

[0079] FIG. 16(e) is an end facing view of the magnetic field generator of FIGS. 16(a) - 16(d);

[0080] FIG. 16(f) is the end facing view of FIG. 16(e), as sectioned at the center thereof;

[0081] FIG. 16(g) is a side elevational view of the magnetic field generator of FIGS. 16(a) - 16(f), including a schematical illustration of a generated magnetic field in accordance with one or more embodiments;

[0082] FIG. 16(h) is the top plan view of the magnetic field generator of FIGS. 16(a) - 16(g), including a schematic illustration of the generated magnetic field;

[0083] FIG. 16(i) is the end facing view of the magnetic field generator of FIGS. 16(a) - 16(g), including a schematic illustration of the generated magnetic field;

[0084] FIGS. 17(a) - 17(c) illustrate perspective views of similar magnetic field generators in accordance with other embodiments;

[0085] FIG. 18(a) is a perspective view of a magnetic field generator made in accordance with another embodiment of the invention;

[0086] FIG. 18(b) is another perspective view of the magnetic field generator of FIG. 18(a);

[0087] FIG. 19(a) is a perspective view of a magnetic field generator (which may be identical or similar to a Helmholtz coil) capable of generating a magnetic field in accordance with another embodiment;

[0088] FIG. 19(b) is a side elevational view of the magnetic field generator of FIG. 19(a);

[0089] FIG. 19(c) is a top plan view of the magnetic field generator of FIGS. 19(a) and 19(b);

[0090] FIG. 19(d) is a top plan view of the magnetic field generator of FIGS. 19(a) - 19(c), including a schematic illustration of the generated magnetic field;

[0091] FIG. 20(a) illustrates a supporting structure including a formed magnetic field generator in accordance with one or more embodiments;

[0092] FIG. 20(b) is a perspective view of a patient supporting structure for a formed magnetic field generator in accordance with one or more embodiments; and

[0093] FIG. 20(c) is a perspective view of the patient supporting structure of FIG. 20(b), illustrating a possible positioning of a patient therein.Detailed Description

[0094] The following describes various embodiments of an apparatus, as well as related methods of treatment using the apparatus, for purposes of reducing scoliosis deformity. It will be apparent that these embodiments are merely examples and other suitable modifications and / or variations can be made. Throughout this discussion, various terms are used for purposes of providing a suitable frame of reference with regard to the accompanying drawings. The drawings are intended to illustrate salient features and are not intended to be used for scalar purposes.

[0095] The herein described apparatus and related method may utilize a generated magnetic field that is so substantially uniform in magnitude and direction, particularly within a defined region of the magnetic field, that the magnetic field can create a substantial net torque on one or more vertebral implants, without creating a substantial net translational force (pulling or pushing) upon the any of the same vertebral implants. This effect is conceptually depicted in FIGS. 1(a) and 1(b), shown on a single vertebral implant.

[0096] A magnetic field that is perfectly uniform in both magnitude and direction is theoretical and is physically impossible to generate in toto, but, as discussed herein, it is possible to generate a magnetic field that is so substantially uniform in both magnitude and direction, particularly within a region of the field, that it can be utilized for purposes described herein.

[0097] In some or all cases, the application of substantial net translational force on one or more of the vertebral implants may be desirable, to supplement the torque acting on each respective implant, for the purpose of achieving a more desirable correction of a scoliotic deformity. A substantial net translational force could be introduced by generating at least one intentional nonuniformity within the highly uniform magnetic field, with the location(s), shape(s), and size(s) of the non-uniformity being specific to each scoliosis case and specific to each therapy session utilizing the magnetic torques and / or forces.

[0098] By way of contrast, if a net translational force on one or more of the vertebral implantsbecomes excessively strong, there could be a significant risk of one or more implants dislodging from their respective implanted positions. This dislodging could produce dire and dangerous results to a patient, likely making the application of excessively strong net translational force(s) undesirable. In addition, using excessively strong net translational magnetic force(s), in some instances, may increase the risk of injury to the patient, due to a possible rapid change in strength of a net translational magnetic force on one or more vertebral implants, depending on the distance between those vertebral implants and the source of a generated magnetic field.

[0099] For purposes of the examples that are described herein, a substantial net translational force on a single implanted vertebral implant can be, for example, a net translational force of at least 10 newtons, applied in any direction. For purposes of the examples that are described herein, an excessive net translational force on a single vertebral implant can be, for example, a net translational force of at least 50 newtons, applied in any direction. In addition, for purposes of this description, a substantial net torque on an implanted vertebral implant, as described herein, can be a net torque of at least 0.1 newton-meters, as defined around any axis in three (3) dimensional space. It should be understood, however, that the foregoing parameters can be suitably varied. Summarily, a substantial net torque and / or substantial net translational force would contribute to a reduction of a scoliotic deformity, given enough time and / or repetitions of that torque and / or force, but, in contrast, an excessive net translational force would result in undesirable and / or dangerous effects.

[0100] For purposes of the present invention, one possible material of a suitable vertebral implant can be a ferromagnetic material. According to at least one embodiment, a material of an implant can be a stainless steel, such as Grade 440-C Steel. According to at least one other embodiment, a material of an implant can be Grade 431 Steel. It will be apparent that other ferromagnetic materials can be utilized, or a combination of materials.

[0101] A vertebral implant, for purposes of at least one embodiment, can be a threaded bolt. A bolt provides a suitable shape because the design of a bolt can be practical for surgical implantation, and there is a clear historical precedent for using bolts and screws in regard to surgical implants. In addition, and significant to the present teachings, a bolt shape can be torqued and / or forced in a useful way by a magnetic field.

[0102] FIG. 1(a) schematically depicts an example of a vertebral implant (also referred to throughout this description throughout synonymously as “an implant”) for schematic purposes and more specifically a vertebral implant 10 that is disposed within a theoretical perfectly uniform magnetic field 12, which is herein schematically presented with a set of field lines 14, the latter depicting the direction of the generated magnetic field. As shown, each of the field lines 14 are equally spaced and parallel to one another (shown as horizontal in this specifically depicted configuration) and consonant or parallel to the major axis of the vertebral implant 10. Given this positioning between the vertebral implant 10 and the field lines 14, the vertebral implant 10 in this scenario would experience a zero net translational force, as is represented in FIG. 1(a).

[0103] FIG. 1(b) depicts the vertebral implant 10 from FIG. 1(a), in the same theoretical perfectly uniform magnetic field 12, but in this specific scenario, the position of the vertebral implant 10 is rotated with respect to the position of the vertebral implant depicted in FIG. 1(a). Accordingly, and as shown by opposing arrows 15, the vertebral implant 10 encounters a net torque. However, and as in FIG. 1(a), the vertebral implant 10 also experiences no net translational force.

[0104] For purposes of the present invention, a very similar effect can be achieved with a generated magnetic field that is substantially uniform within a defined finite region of the field, as discussed in greater detail herein. The finite region provides a boundary within which a magnetic field is substantially uniform, and therefore is practically interchangeable with the theoretical perfectly uniform magnetic field shown in FIGS. 1(a) and 1(b).

[0105] FIG. 2(a) depicts an embodiment of a vertebral implant 20 to be used as an implant in accordance with aspects of the present invention, as shown in a perspective view. As previously noted, a bolt is one of many alternatives that can be used as a vertebral implant for the herein described method and apparatus. The vertebral implant 20 according to this embodiment includes a set of external threads over its entire length or substantially the entirety of its overall length, wherein the vertebral implant 20 is a solid or substantially solid member having respective distal and proximal ends.

[0106] FIG. 2(b) depicts the same vertebral implant 20 as depicted in FIG. 2(a), as shown in a sideelevational view. For purposes of this embodiment, the axial length of the vertebral implant 20 forpurposes of this embodiment can range between 5 millimeters to 200 millimeters, the diameter of the vertebral implant 20 can range from 0.1 millimeters to 50 millimeters, the pitch of the threads of the vertebral implant 20 can range from 0.01 millimeters to 20 millimeters, the depth of the threads of the vertebral implant 20 can range from 0 to 20 millimeters, and the angle of the threads of the vertebral implant 20 can range from 1 to 179 degrees, each as schematically represented in FIG. 2(b). It should be noted that each of the foregoing parameters can be suitably varied. As further discussed herein, the goal of the vertebral implant 20 is to be implanted within one or more vertebrae of a patient

[0107] FIG. 3(a) depicts a vertebral implant 30 made in accordance with an alternative embodiment, as shown in a perspective view. The vertebral implant 30 according to this embodiment is similar to the threaded bolt shown in FIGS. 2(a) and 2(b), but is defined by a frusto-conical configuration that includes a taper 33 between the respective distal 34 and proximal ends 38 of the vertebral implant 30. The overall dimensions noted above (pitch, thread angle, length, etc.) can be similar for this specific embodiment.

[0108] FIG. 3(b) depicts the same vertebral implant 30 as depicted in FIG. 3(a), as shown in a sideelevational view. As represented in this figure, the term “ANGLE” refers to the angle of the taper 33, which can range between 0.1 and 89 degrees. According to the herein depicted embodiment, by way of example, the angle of the taper 33 can be about 10 degrees in which the diameter of the vertebral implant 30 is at a minimum at the distal end 34, and at a maximum at the proximal end 38.

[0109] FIG. 4(a) depicts a single vertebra having an implanted vertebral implant, such as those previously described, as shown in a translucent perspective view. In this depicted embodiment, the vertebral implant 20 depicted has a configuration similar to that previously described in FIGS. 2(a) and 2(b). Accordingly, the same reference numbers are used for the sake of clarity. Though not shown in this figure and for purposes of the herein described invention, a number of vertebrae in a spine (not shown in FIG. 4(a)) of a subject can include similar implanted vertebral implants. It will also be understood that a tapered implant such as implant 30, FIG. 3(a), could also be substituted in this embodiment, as well as other suitably implantable objects in which the foregoing is merely intended to describe an example.

[0110] FIG. 4(b) depicts the same scenario as that depicted in FIG. 4(a), but as shown in a translucent top elevational view, showing a single vertebra 50 having a vertebral implant 20 implantedtherein. According to this specific embodiment, the major axis of the implanted vertebral implant 20 is nearly perfectly parallel to or consonant with the lateral (left to right) axis of the vertebra 50.

[0111] As to positioning within the vertebra 50, it will be understood that the vertebral implant 20 depicted in FIG. 4(b) can be positioned closer to the back or rear of the vertebral body, or closer to the front of the vertebral body.

[0112] FIG. 4(c) depicts the same scenario as that of FIGS. 4(a) and 4(b), but with the vertebra 50 and implanted vertebral implant 20 being shown in a translucent front elevational view for the sake of clarity. According to this specific embodiment, the major axis of the implanted vertebral implant 20 is nearly perfectly parallel to the lateral axis of the vertebra 50. It will be understood that the implanted vertebral implant 20 depicted in FIG. 4(c) can be positioned closer to the top of the vertebral body, or closer to the bottom of the vertebral body.

[0113] FIG. 5 depicts another exemplary embodiment of an implanted vertebral implant 20 within a single vertebra 50. As in the prior discussion, similar parts are herein labeled with the same reference numbers for the sake of clarity. More specifically, this implantation is similar to that depicted in FIGS. 4(a), 4(b), and 4(c), and is shown in a translucent front elevational view. As in the prior embodiment, the major axis of the implanted vertebral implants 20 is nearly perfectly parallel to or consonant with the lateral axis of the vertebra 50.

[0114] However, and according to this specific embodiment, as depicted in FIG. 5, at least a portion of an implanted vertebral implant 20 protrudes outwardly away from the vertebral body 50, as shown by protrusion 25. If a vertebral implant protrudes, such as the bolt 20 depicted in FIG. 5, the torque and / or force may increase due to the greater amount of mass of the implant, which may result in stronger force interaction with the externally generated magnetic field. In addition, the implant 20 can be easier to access in a revision surgery than a vertebral implant that does not protrude from the vertebral body.

[0115] It will be understood that the amount of the protrusion 25 of the vertebral implant 20 can be larger or smaller than the amount shown in FIG. 5, and / or could be differently shaped. As previously noted, it will also be understood that an implanted vertebral implant having a protrusioncan be suitably positioned closer to the back of the vertebral body, closer to the front of the vertebral body, closer to the top of the vertebral body, or closer to the bottom of the vertebral body. In addition, the angle between the radial axis of a protruding vertebral implant and the lateral axis of the corresponding vertebra 50 can range from 0 to 89 degrees.

[0116] FIG. 6 depicts a vertebra having an implant 20, as shown in a translucent top elevational view, and in accordance with another embodiment. According to this specific embodiment, the major axis of the implanted vertebral implant 20 is positioned at a predetermined angle, relative to the lateral axis of the vertebra 50. As represented in FIG. 6, the term “ANGLE” refers to the angle formed between the major axis of the implanted vertebral implant 20 and the lateral axis of the vertebra 50. The “ANGLE” can range between 0.1 to 89 degrees.

[0117] FIG. 7 depicts a vertebra having an implanted vertebral implant 20, as shown in a translucent front elevational view. According to this specific embodiment, the major axis of the vertebral implant 20 is positioned at an angle, relative to the lateral axis of the vertebra 50. As in the preceding, the term ANGLE refers to the angle formed between the major axis of the implant 20 and the lateral axis of the vertebra. This ANGLE can range from 0.1 to 89 degrees. In each of the preceding embodiments, it will be understood that the implanted vertebral implant 20 can be positioned closer to the top of the vertebral body, and / or closer to the bottom of the vertebral body, and / or closer to the back of the vertebral body, and / or closer to the front of the vertebral body.

[0118] It will also be understood that a vertebral implant as previously described according to any of the prior embodiments can also be positioned with a combination of angle components from more than a single plane (e.g., the top plane and the front plane) such as those shown in FIGS. 6 and 7.

[0119] There are further variations for purposes of implanting vertebral implants, such as threaded bolts, in accordance with the herein described teachings. For example, more than one (1) vertebral implant can be implanted into a single vertebra. FIG. 8(a), for example, depicts a perspective view of a single vertebra 50 having two (2) implanted vertebral implants 60 (shown translucently), which are implanted surgically in adjacent side by side in relation to one another.

[0120] This implantation of more than one (1) vertebral implant within a single or multiplevertebrae can be beneficial because this inclusion can increase the overall magnitude of a torque and / or force created by a generated magnetic field, with all other factors being equal.

[0121] In addition, implanting two (2) or more vertebral implants 60 having smaller diameters may preserve the structural integrity of an implanted vertebra 50 more reliably than implanting a single vertebral implant having a diameter that is larger than the individual diameters of the two (2) or more previously mentioned implants 60.

[0122] FIG. 8(b) depicts the same scenario as that depicted in FIG. 8(a), illustrating a pair of side-by-side vertebral implants (bolts 60), as shown in a translucent top elevational view that are implanted within one or more vertebrae of a patient. The major axes of the implanted vertebral implants 60 according to this embodiment are nearly perfectly parallel to or consonant with the lateral axis of the vertebra 50.

[0123] As previously discussed in prior embodiments, the vertebral implants 60 can be positioned closer to the back of the vertebral body, and / or closer to the front of the vertebral body, and / or closer to the top of the vertebral body, and / or closer to the bottom of the vertebral body. The vertebral implants as implanted within a single vertebra can be placed closer to each other or farther away from each other.

[0124] It should further be noted, though not shown here, that the major axes of each of the implanted vertebral implants 60 can be placed an angle, relative to the lateral axis of the vertebra 50.

[0125] FIGS. 9(a) and 9(b) depict a pictorial view of a spine 70 of a subject 100 having a plurality of vertebral implants 80 implanted into a plurality of vertebrae 50, as shown in a translucent front elevational view. For purposes of the present invention, one or more vertebral implants can be implanted in each vertebra 50, or only a single vertebra 50, or any combination of vertebrae 50.

[0126] In practice, specific selections of vertebrae will be more suitable for implantation, and invariably will depend on the particular scoliotic shape being treated.

[0127] This embodiment depicts a number of vertebrae 50 having surgically implantedvertebral implants 80 in accordance with aspects of the present invention. For purposes of this discussion, the vertebral implants 80 (or “implants”) are similar to those previously described by reference number 20.

[0128] FIG. 10(a) depicts a single vertebra 50 having an implanted vertebral implant 80, within a theoretical and perfectly uniform magnetic field 120, as schematically shown.

[0129] Reference number 90 is used to represent a plurality of magnetic field lines of the theoretical perfectly uniform magnetic field 120 that is schematically shown in this view. The magnetic field lines 90, shown schematically, are consistent in terms of magnitude and direction and are disposed in a parallel fashion. As previously noted, a defined finite region of a generated magnetic field can effectively replicate that of the theoretical uniform magnetic field illustrated in FIG. 10(a).

[0130] In this scenario, the theoretical perfectly uniform magnetic field 120 would not create a substantial net torque on the vertebral implant 80, because the major axis of the implanted vertebral implant 80 is nearly perfectly aligned with the magnetic field lines 90, as shown in FIG. 10(a). The major axis of the implant 80 is also consonant according to this embodiment with the lateral axis of the vertebra 50.

[0131] FIG. 10(b) depicts the single vertebra 50 with the implanted vertebral implant 80, within the uniform magnetic field 120, as shown in a translucent front elevational view.

[0132] As in the preceding, lines 90 represent a plurality of magnetic field lines of the theoreticalperfectly uniform magnetic field 120, each of the field lines 90 being consistent in terms of magnitude and direction. The arrows 104, on the other hand, represent a desirable torque that would be created upon a vertebral implant 80 by the theoretical perfectly uniform magnetic field 120.

[0133] In this scenario, the theoretical perfectly uniform magnetic field 120 would be able to create a substantial net torque on the implanted vertebral implant 80, because the major axis of the implanted vertebral implant 80 is not parallel with the magnetic field lines 90. In addition, and in this scenario, due to the substantial uniformity of the magnetic field 120, there would be no substantial net translational force, in any direction, created on the vertebral implant 80 by the generated magneticfield 120.

[0134] FIG. 10(c) depicts yet another scenario including a single vertebra 50 having an implanted vertebral implant 80, relative to a theoretical perfectly uniform magnetic field 120, as shown in a translucent front elevational view.

[0135] As in the preceding examples, lines 90 represent the plurality of magnetic field lines of atheoretical perfectly uniform magnetic field 120.

[0136] In this scenario, the theoretical perfectly uniform magnetic field 120 would not create a substantial net torque on the implanted vertebral implant 80, because the major axis of the implanted vertebral implant 80 is nearly perfectly perpendicular to the orientation of the magnetic field lines 90.

[0137] In this orientation, the torque of the implanted vertebral implant 80 would be in an unstable equilibrium, meaning that the torque in this position would be nearly or completely equal to zero (0), but if the implanted vertebral implant is rotated in the plane of the image, a substantial net torque could then be created on the bolt 80 by the magnetic field 120, this created torque being in the direction of the rotation, until the major axis of the implant 80 becomes parallel with the magnetic field lines 90. At this latter point, the torque on the implant 80 would be practically zero (0) again. This depicted orientation of a vertebra and implanted vertebral implant may not be desirable in an actual therapy session and is only depicted in this instance to illustrate an extreme condition.

[0138] FIG. 11(a) depicts the scenario according to FIG. 10(a) of a single vertebra 50 having an implanted vertebral implant 80 disposed within a theoretical perfectly uniform magnetic field 120, but is shown in a translucent top elevational view.

[0139] As in the preceding, the parallel spaced lines 90 pictorially represent a plurality of magnetic field lines of the theoretical perfectly uniform magnetic field 120, each of the field lines being consistent in terms of magnitude and direction.

[0140] As previously noted and in this specific scenario, the theoretical perfectly uniform magnetic field 120 would not create a substantial net torque on the implanted vertebral implant 80, because the major axis of the implanted vertebral implant 80 is nearly perfectly aligned or consonantwith the magnetic field lines 90.

[0141] FIG. 11(b) depicts yet another scenario of a single vertebra 50 having an implanted vertebral implant 80, within a theoretical perfectly uniform magnetic field 120, as shown in a translucent top elevational view.

[0142] As in the preceding scenarios, lines 90 represent a plurality of magnetic field lines of a theoretical perfectly uniform magnetic field 120. Arrows 104 represent a torque that would be created on the implanted vertebral implant 80 by the theoretical perfectly uniform magnetic field 120.

[0143] In this scenario, the theoretical perfectly uniform magnetic field 120 can create a substantial net torque on the implanted vertebral implant 80, due to the misalignment of the major axis of the implanted vertebral implant 80 relative to the lines 90 of the magnetic field 120.

[0144] FIG. 11(c) depicts another scenario illustrating a single vertebra 50 having an implanted vertebral implant 80, within a theoretical perfectly uniform magnetic field 120, as shown in a translucent top elevational view. As in the preceding, lines 90 represent a plurality of magnetic field lines of a theoretical perfectly uniform magnetic field 120.

[0145] In this specific scenario, the theoretical perfectly uniform magnetic field 120 would not create a substantial net torque on the implanted vertebral implant 80, because the major axis of the implanted vertebral implant 80 is nearly perfectly orthogonal to the magnetic field lines 90.

[0146] In this latter orientation, the torque of the implanted vertebral implant 80 would be in an unstable equilibrium, meaning that the torque in this position would be practically zero (0), but if the implanted vertebral implant 80 was rotated in the plane of the represented image, a net torque could then be created on the implant by the magnetic field 120, the torque being in the direction of the rotation, until the major axis of the implant 80 becomes parallel with the magnetic field lines 90, at which point the torque on the implant would be practically zero (0) again. This depicted orientation of a vertebra 50 and vertebral implant 80 would not be desirable in an actual therapy session and is only depicted here to explain an extreme condition.

[0147] FIG. 12(a) depicts a scoliotic spine 204 of a subject 200, as shown in a translucent front elevational view, with one of many possible positionings of a number of implanted vertebral implants 80 in accordance with aspects of the present invention.

[0148] FIG. 12(b) depicts the scenario as shown in FIG. 12(a), as shown in a translucent front elevational view, but within a surrounding theoretical perfectly uniform magnetic field 120, further illustrating the resultant torques on each of the implanted vertebral implants 80.

[0149] More specifically and as in the preceding, the lines 90 represent the magnetic field lines of a theoretical perfectly uniform magnetic field 120. Arrows 104 represent torques that would be created on a number of the implanted vertebral implants 80 under the influence of the theoretical perfectly uniform magnetic field 120.

[0150] If any of the major axes of the implanted vertebral implants 80 are not parallel with the magneticfield lines 90, these nonaligned implants 80 would experience a torque, represented by arrows 104 at opposing ends of the implant 80, acting to rotate the implants and therefore the lateral axes of the vertebrae of the spine toward an alignment with the magnetic field lines 90, but without creating a substantial net translational force on any of the vertebral implants.

[0151] FIG. 12(c) depicts the same implanted vertebral implant positions, relative to the corresponding vertebrae 50, as shown in FIGS. 12(a) and 12(b), but within a stronger theoretical perfectly uniform magnetic field 120A, thereby resulting in stronger torques created on the implanted vertebral implants 80. Alternatively, the foregoing represents the same strength magnetic field and over a passage of time, wherein the spine has adjusted and changed position as a result of creep from the applied stresses. Alternatively, the foregoing represents a lasting and / or permanent correction of a scoliotic deformity due to the application of magnetic torques and / or forces for a sufficient quantity of time and / or repetitions.

[0152] More specifically and as previously discussed, lines 90 represent a plurality of magnetic field lines of the stronger theoretical perfectly uniform magnetic field 120A. Arrows 104 represent torques that could be created on a number of implanted vertebral implants 80 by the generated magnetic field 120A.

[0153] One potential problem with the positions of the implanted vertebral implants 80 depicted in FIGS. 12(a) -12(c), is that when the spine 204 approaches a non-scoliotic position, the torques on the vertebral implants 80 may approach zero. That zeroing may make it difficult to achieve a complete correction of the scoliosis deformity, because the torques may become too small to move the spine 204 to a complete correction. One possible solution is to change the angle of the major axis of one (1) or more of the implanted vertebral implants 80 relative to the lateral axes of the corresponding vertebrae. One possible example of this positioning is depicted in FIG. 12(d).

[0154] FIG. 12(d) depicts similar positions of the implanted vertebral implants 80 as those shown in FIGS 12(a) -12(c), but with a number of the major axes of the bolts 80, positioned during implantation, disposed or positioned at an angle relative to the lateral axis of their corresponding vertebrae 50. As in the preceding examples, lines 90 represent the magnetic field lines of a theoretical perfectly uniform magnetic field 120 and the arrows 104 represent the resultant torques that would be created on a number of implanted vertebral implants 80 by the theoretical perfectly uniform magnetic field 120.

[0155] With the angled implant positions, as shown, a number of the implanted vertebral implants 80 can provide a torque even when the spine 204 is in a completely non-scoliotic position. This technique can also be applied to the rotational component of a scoliosis deformity, by positioning implanted vertebral implants 80 similarly to that depicted in FIG. 6.

[0156] As previously discussed, the generation of a magnetic field that is substantially uniform within a finite region of the field, effectively replicates that of the theoretically uniform magnetic field within the finite region. A substantially uniform magnetic field (and therefore the finite region generated herein) would not create a substantial net translational force on a vertebral implant, but at the same time could create a substantial net torque on the same vertebral implant.

[0157] For purposes of the following discussion, a magnetic field generator was designed to create a magnetic field that is close enough in magnitude and direction to the magnitude and direction of a theoretical perfectly uniform magnetic field, within the region where a patient would utilize the magnetic field such that the torque or combination of torques created on one or more implantedvertebral implants can move a scoliotic spine toward a non-scoliotic shape. For purposes of this embodiment, the creation of torques is done, but without creating a substantial net translational force on any of the implanted vertebral implants. However and according to at least one version as previously discussed, the creation of a substantial net translational force may be preferential. Hereinafter, and concerning the creation of a uniform magnetic field, what is meant is that a finite region of the generated magnetic field will be sufficiently uniform for purposes of being similar to lines 90 of the theoretical magnetic field 120.

[0158] Exemplary embodiments of a magnetic field generator, and some related design processes and logics for the above-noted purpose(s) are now provided:

[0159] FIGS. 13(a) - 13(c) depict a first embodiment of a magnetic field generator for use in the generation of a substantially uniform magnetic field, as discussed above. This specific embodiment is that of a solenoid 300, which is chiefly defined by a cylindrical coil of wire 304 having respective ends 308 to which an electrical current can be supplied, and can be used to generate a substantially uniform magnetic field within a finite region inside of the coil 304.

[0160] According to this embodiment, two (2) vertical columns 312 are formed at the opposing ends 308 of the cylindrical coil of wire, acting as input / output for an electrical current to be applied to the coil 304. These columns 312 are only shaped as long columns in this example to simplify electromagnetic simulations. It should be noted that the latter features are not a critical part of the coil.

[0161] FIGS. 13(d) - 13(f) each depict a magnetic field 320 generated by the solenoid 300 of FIGS. 13(a) - 13(c), when electrical current flows through the cylindrical coil 304. The arrows 316 represent the direction of the generated magnetic field 320.

[0162] The displayed magnetic field strengths and directions are derived from cross sectional planes, located in the middle of the solenoid 300. Moreover, the generated magnetic field 320 is substantially uniform near the middle region of the herein described solenoid 300.

[0163] A solenoid shape or configuration may or may not be optimal for purposes of the present invention, depending, in part, on the overall size of the solenoid 300, which may or may not betoo large to fit in most treatment rooms of a medical facility. However, the magnetic field generator may alternatively be configured into a more practical shape, as shown below.

[0164] With reference to FIG. 14(a), there is depicted a second embodiment of a magnetic field generator. This particular design can be thought of as a modified solenoid 400 having an oblong or substantially elliptical cross section in lieu of a circular cross section, and may be proportionally shorter than the solenoid 300 of FIGS. 13(a) - 13(c).

[0165] The modified solenoid 400 according to this embodiment is defined by a coil 404 having respective ends 408. As in the preceding described design, there are two vertical columns 412 provided at each end 408 of the coil 404 to serve as input and output of electrical current. As previously noted, the vertical columns 412 are only shaped as long columns to simplify electromagnetic simulations. These latter features are not a critical part of a coil 404 or the overall magnetic field generator design.

[0166] FIG. 14(b) depicts one version depicting the relative positioning of a patient 430 relative to the modified solenoid 400 of FIG. 14(a), and the approximate relationship between the size of the modified solenoid 400 and size of the patient 430, as herein shown in a perspective view.

[0167] FIG. 14(c) depicts the modified solenoid 400 of FIGS. 14(a) and 14(b), but herein shown in a side elevational view. The dimension “HEIGHT 1” as marked herein refers to the tallest outer dimension of the formed coil 404. It will be understood that this specific dimension can be proportionally taller or shorter than that shown. The dimension “LENGTH 1” as marked herein refers to the longest outer dimension of the coil 404. Similarly, this latter dimension can also be proportionally longer or shorter than that shown.

[0168] FIGS. 14(d) and 14(e) further depicts the modified solenoid 400 of FIGS. 14(a) - 14(c). The dimension “WIDTH 1” as marked herein refers to the widest outer dimension of the coil 404. It will be understood that this specific dimension can be proportionally longer or shorter than that shown.

[0169] FIGS. 14(f) - (h) depict a magnetic field 420 generated by the modified solenoid 400 of FIGS. 14(a) - 14(e), when electrical current flows through the coil 404. The intensity and direction ofthe generated magnetic field is shown by the relative size and direction of the arrows 416. The displayed magnetic field strengths and directions are derived from cross sectional planes, which are located near the middle of the magnetic field generator.

[0170] FIG. 15(a) depicts a third alternative embodiment of a magnetic field generator 500 for purposes of the present invention. This particular design or configuration is a further modification of the embodiment of FIGS. 14(a) - 14(e), though having a different shape, as compared to the preceding embodiments, which is designed to generate a magnetic field that more closely resembles a theoretical perfectly uniform magnetic field within the finite region where the patient would utilize the magnetic field generated by the field generator 500, as compared to the prior described embodiments.

[0171] As previously described, the magnetic field generator 500 according to this embodiment is defined by a coil 504 of wire having respective ends 508, as well as two (2) vertical columns 512 that are disposed at the respective ends 508 of the coil 504 to serve as the input / output for an applied electrical current. These latter features 512 are only shaped as long columns to simplify electromagnetic simulations and are not a critical part of the coil.

[0172] The major modification according to this third coil embodiment is a varying size of the coil loops 509 of the coil 504, as now described in greater detail. Otherwise, this design is similar to each of the preceding versions.

[0173] FIG. 15(b) depicts schematically an example of how a patient 530 may be oriented relative to the formed magnetic field generator 500 of FIG. 15(a), and the approximate relationship between the overall size of the generator 500 and the patient 530.

[0174] FIG. 15(c) depicts the design of the magnetic field generator 500 of FIGS. 15(a) and 15(b), with reference to a side elevational view. According to this embodiment, the coil 504 forms a configuration defined by a set of dimensions including “HEIGHT 1”, which refers to the tallest outer dimension of the coil 504, “HEIGHT 2”, which refers to the tallest inner dimension of the coil 504, “LENGTH 1”, which refers to the longest outer dimension of the coil 504, and “LENGTH 2”, which refers to the longest inner dimension of the coil 504. Each of these dimensions can be proportionally longer or shorter than that shown, wherein the length dimensions “LENGTH 1” and “LENGTH 2” according to this embodiment are each larger than the corresponding height dimensions, namelyHEIGHT 1 and HEIGHT 2, respectively.

[0175] FIG. 15(d) depicts the magnetic field generator 500 of FIGS. 15(a)- 15(c), as shown in a top elevational view. As can be seen, the coil 504 according to this embodiment is defined by the series of coil loops 509 having progressively different lengths over the width of the coil 504, with the longest loop lengths being at and / or around the middle loops, and the shortest loop lengths at the respective ends 508 of the coil 504.

[0176] For purposes of this embodiment, the “WIDTH” dimension refers to the widest outer dimension of the coil. “WIDTH” can be proportionally longer or shorter than shown.

[0177] The dimension referred to as “ARC” refers to the profile of the end edges of the coil loops 509, which according to this embodiment is defined by a substantially convex shape given the difference in lengths of the coil loops 509. The “ARC” dimension can have a different shape other than convex, which is shown merely as an example.

[0178] FIG. 15(e) further illustrates the electromagnet of FIGS. 15(a) - 15(d), as shown in an end elevational view. The dimension “ARC 1” refers to the profile of the top edge of the coil loops 509. As previously noted, “ARC 1” can have a different shape other than convex, as shown. It should also be noted that “ARC 1” of FIG.15(e) does not have to be the same shape as “ARC” of FIG. 15(d).

[0179] FIGS. 15(f) - 15 (h) depict a magnetic field 520 generated by the magnetic field generator 500 of FIGS. 15(a) -15(e), at a time that electrical current flows through the coil 504.

[0180] The displayed magnetic field strengths and directions as shown by arrows 516 are derived from cross sectional planes located near the middle of the magnetic field generator 500.

[0181] FIG. 16(a) depicts a fourth embodiment of a magnetic field generator 600, as shown in a perspective view. This particular embodiment is a modification upon the embodiment of FIGS.15(a) - 15(e) and is configured with a different shape that is configured to generate a magnetic field that more closely resembles a theoretical perfectly uniform magnetic field, within the finite region of the generated field in which the patient would utilize it. Otherwise, the magnetic field generator 600 is similar to the preceding versions including a coil 604 of wire made up of loop coils 609 and havingrespective ends 608, as well as input and output columns 612 for an electrical current.

[0182] FIG. 16(b) depicts approximately how a patient 630 would be oriented in the magnetic field generator 600 of FIG. 16(a), and the approximate relationship between the size of the generator 600 and that of a patient. The size of the generator 600 can be scaled to match the size of a patient. That is, for a smaller patient, a smaller generator can be used. For a larger patient, a larger generator can be used.

[0183] FIG. 16(c) depicts the magnetic field generator 600 of FIGS. 16(a) and 16(b), as shown in a top elevational view. A plurality of dimensions are labeled for convenience and description of this exemplary design.

[0184] More specifically, the dimension “WIDTH 1” refers to the widest outer dimension of the coil 604, the dimension “WIDTH 2” refers to the narrowest outer dimension of the coil 604, “ARC 1” refers to the profile of the end edges of the coil loops 609, which is convex in configuration according to this embodiment, but could have a different shape. In addition, the dimension “ARC 2” refers to the bend of the outermost loop 609 of the coil 604, which is concave according to this embodiment, but could have a different shape, the dimension “GAP 1” refers to the distance between the centers of loops 609 of the coil 604, and the dimension “GAP 2” refers to the distance between the centers of the two (2) outer loops 609 of the formed coil 604.

[0185] It will be understood that each of the herein described dimensions can be proportionally largeror smaller than that shown here. Moreover, each of “ARC 1” and “ARC 2” can possess an alternative shape and “GAP 1” and / or “GAP 2” can be proportionally larger or smaller. According to at least one embodiment, however, GAP 2 should be larger than GAP 1. The rate of change of the gap distance between the dimensions GAP 1 and GAP 2 can be linear, parabolic, or a variant.

[0186] FIGS. 16(d) - 16(f) further depict the magnetic field generator 600 of FIGS. 16(a) - 16(c). Several dimensions of the coil 604 are shown for convenience. More specifically, the dimension “HEIGHT 1” refers to the tallest outer dimension of the coil, the dimension “HEIGHT 2” refers to the tallest inner dimension of the coil 604, “LENGTH 1” refers to the longest outer dimension of the coil 604, and the dimension “LENGTH 2” refers to the longest inner dimension of the coil 604. Each of theforegoing dimensions can be proportionally longer or shorter than those shown in this specific embodiment.

[0187] In addition, the dimension “ARC 1” of FIG. 16(e) refers to the curvature of the tallest and outermost regions of the coil loop 609, and the dimension “ARC 1” of FIG. 16(f) refers to the curvature of the shortest, innermost coil loops 609, as seen in a sectioned end elevational view. Each can have a different shape other than that shown in FIGS. 16(e) and 16(f).

[0188] FIGS. 16(g) - 16(i) each depict a magnetic field 620 that is generated by the magnetic field generator 600 of FIGS. 16(a) - 16(f), when an applied electrical current flows through the electromagnet 600 via inlet / outlets 612. The displayed magnetic field strengths and directions are derived, per arrows 616, from cross sectional planes, located near the middle of the magnetic field generator 600.

[0189] Various combinations of cross-sectional wire areas and number of coil loops can generate nearly identical magnetic fields as each other in terms of their shape, as long as the overall shape remains similar enough between any 2 adjacent coils. This latter concept is shown in FIGS. 17(a) - 17(c) by respective coils 640, 660 and 680 having respective coil loops 642, 662, 682, where each coil shown could generate a very similar magnetic field to the others. This concept can be applied to any embodiment of an electromagnet design for purposes of the present invention. It should further be noted that the wire density can be much higher than what is presently shown, and the individual wire cross sectional shape can be different than circular.

[0190] FIG. 18(a) depicts yet another embodiment of a magnetic field generator 700 having a coil 704 made in accordance with another embodiment. According to this embodiment, the coil 704 includes a first coil layer 713 as well as an additional or second coil layer 726. Adding a second coil layer 726 allows the end of the wire of the coil 704 to return near to the start position of the wire as opposed to having the start and end positions of the wire being on opposite sides of the formed electromagnet. This double layered arrangement can be convenient for electrical current management and can also help increase the uniformity of the generated magnetic field, specifically within the finite region in which the patient would utilize the magnetic field, as compared to an electromagnet having only a single coil layer.

[0191] The wire can coil from one side of the magnetic field generator 700 to the opposing side over the first coil layer 713, and then coil back toward the original side via the second coil layer 726, the latter essentially following a shape similar to the original coil layer 713.

[0192] It will be understood that there are variants and modifications that can be added. For example, and if desired, more than two wire layers can be added by repeating the same layered coiling process, as described above. This layered coil technique can be applied to any of the herein described embodiments of an electromagnet or variants thereof.

[0193] FIG. 18(b) depicts the magnetic field generator of FIG. 18(a), as shown in a different perspective view than that previously shown in FIG. 18(a). This different view depicts a connection between the outer coil 726 and inner coil 713.

[0194] With reference to FIGS. 19(a) - 19(d), there is shown an alternative design for a magnetic field generator 800 that is capable of generating a magnetic field within a finite region that is essentially equivalent to that of a theoretically uniform magnetic field. This specific generator 800 can be identical or similar to a Helmholtz coil, the latter made up a pair of circular conductive paths, with the axes of both circles in line with each other. In this embodiment, a patient would likely be positioned in between the two (2) coil loops, in or near the middle, with one coil loop 804 being approximately on the right side of the patient and one coil loop 808 being approximately on the left side of the patient.

[0195] FIG. 19(a) depicts an embodiment of a magnetic field generator, as shown in a perspective view. The generator 800 is comprised of at least 2 main coils, namely coils 804 and 808 which would be positioned on either side of a patient. The electrical current in both of the coils 804, 808 would most likely be the same magnitude, and would most likely be flowing in the same direction, circumferentially around the loop. In FIGS. 19(a) - 19(c), the precise input and output of the electrical current is not depicted.

[0196] FIG. 19(b) depicts the magnetic field generator 800 of FIG. 19(a), but as shown from a side elevational view.

[0197] FIG 19(c) depicts the magnetic field generator 800 of FIGS. 19(a) and 19(b), but as shown from a top plan view.

[0198] FIG 19(d) depicts the magnetic field generator of FIGS. 19(a) - 19(c), as shown from a top plan view, and including a schematic depiction of a generated magnetic field 820, due to current flowing through the coils 804, 808. As can be inferred from the sizes of the arrows 824, regions of the generated field 820 that are nearest to the middle of the generator 800 can be substantially uniform and therefore useful for reasons previously discussed in detail.

[0199] An ideal surrounding structure would be configured to retain the magnetic field generator, such as any of those previously described or variants thereof wherein the shape of the surrounding structure would conform therewith. The magnetic field generator would be configured to generate a suitable magnetic field would safely bear the load of the self-induced wire forces and be as small and as light as is reasonably possible. According to at least one embodiment, the supporting structure could be made from aluminum. In accordance with other embodiments, the surrounding structure can be made from carbon fiber, titanium, or another suitable structural material, or alternatively, a combination of these and / or other suitable structural materials.

[0200] One embodiment of a surrounding structure 1000 for a magnetic field generator is shown in FIGS. 20(a) - 20(c). It will be understood that the depicted structure is exemplary and therefore alternative designs could be used. The main purpose of the supporting structure 1000 is to retain and support the wires of a contained magnetic field generator well enough to allow safe and proper functioning at the strongest magnetic field that would be used and applied in a therapy session.

[0201] If the chosen material of the wire is superconductive, then the use of a liquid coolant, like helium or nitrogen, is probably necessary to reach a superconducting state. The wires of the electromagnet can be cooled by a liquid coolant to reach temperatures low enough to permit superconduction. The coolant can be contained by the surrounding structure 1000, for example, in a chamber surrounding the wires.

[0202] FIG. 20(a) depicts a portion of a surrounding structure 1000 relative to the formedelectromagnet. For purposes of this example, the magnetic field generator 600 is employed. The structure 1000 according to this embodiment is defined by inner and outer housing layers 1008 and 1012 (outer housing layer 1012 is not shown in FIG. 20(a)), as well as an oblong space 1009. Within the defined space 1009, a bed surface 1004 is positioned on a portion of the inner housing layer 1008. The magnetic field generator 600 as shown is wholly disposed within the formed housing / supporting structure 1000.

[0203] FIG. 20(b) depicts both the inner and outer layers 1008, 1012 of the surrounding structure 1000, and the bed surface 1004. As noted, the bed surface 1004 can be formed within the defined space 1009 of the supporting structure 1000, whose shape approximates that of the magnetic field generator 600.

[0204] FIG. 20(c) depicts how a patient 1030 would be oriented relative to the supporting structure 1000 for purposes of receiving therapy.

[0205] The magnetic field generator 600 can be powered, by way of example, with a single direct current, flowing in through an input wire, and out through an output wire relative to columns 612.

[0206] An electrical conductor can be a normal resistive conductor, including but not limited to copper, or an electrical conductor can be a superconductor (having zero electrical resistance), including but not limited to Niobium Titanium (NbTi), Niobium Tin (NbaSn), or Yttrium Barium CopperOxide (YBCO). Other suitable materials can be used. An electrical conductor can also be made of a combination of materials.

[0207] If an electromagnet of the magnetic field generator is superconducting, a superconducting loop can be used to increase electrical efficiency. In that case, a second coil layer could be formed similarly to the coil depicted in FIGS. 18(a) and 18(b).

[0208] In terms of use and according to at least one embodiment, a therapy session should begin withthe magnetic field generator powered off.

[0209] Before a therapy session begins, a patient 1030 can lay in or proximate to the middle of a supporting structure 1000 supporting an electromagnet 600, in a similar orientation as shown in FIG. 20(c). The patient 1030 may be required to be faced up or faced down, in order for the magnetic torques and / or forces to apply properly. In addition, a patient may be permitted to sit up, and / or bend their spine forward and backward, even while the magnetic field generator is powered on and creating substantial torques and / or forces.

[0210] Once a patient is in an acceptable position, which according to this embodiment is in a prone position, the magnetic field generator 600 can be powered on. The amount of electrical current flowing through the generator can affect the strength of the generated magnetic field. The amount of electrical current that is flowing through an electromagnet can change in any way, at any time throughout a therapy session.

[0211] The strength of a generated magnetic field can affect the strength of a torque created on any implanted vertebral implant. The maximum strength of a magnetic field generated by an electromagnet for example, in the regions which pass through implanted vertebral implants, can range from zero (0) Teslas, to fifty (50) Teslas, but up to two (2) Teslas would be sufficient in most cases, not including any additional magnetic field strength that would be generated by each vertebral implant. The amount of electrical current needed to generate a magnetic field for the present invention will depend, in part, on the number of coil loops and the size of that magnetic field generator. The appropriate amount of electrical current for any embodiment of a magnetic field generator can be determined by electromagnetic simulations, and / or by physically measuring the strengths of the generated magnetic fields.

[0212] There are a number of potential surgical methods for the herein described invention for purposes of implanting one or more vertebral implants. For example, some of these methods may follow or be similar to a varied number of already existing spine surgery methods. In at least one embodiment, one or more of the vertebral implants used in the present invention can be placed in very similar positions as the screws used in vertebral body tethering (VBT) and / or anterior scoliosis correction (ASC), so many of the surgical techniques may be very similar to that latter procedure. Such details are conventionally well known to a person of sufficient skill in the field and do not necessarily form a part of the invention.

[0213] Moreover, the surgical technique for purposes of implantation can vary, for example depending upon whether the implantation takes place in the thoracic spine, or alternatively in the lumbar spine. To that end, if the surgery takes place in the thoracic spine, a thoracoscopic technique can be used. This technique is common in vertebral body tethering surgery because this latter technique is considered to be minimally invasive.

[0214] If the surgery takes place in the lumbar spine, the surgical technique can greatly differ from fusion or tethering. Instead, the surgical approach to access the spine can be similar to that of a conventional Extreme Lateral Interbody Fusion (XLIF) surgical procedure. There may be no single large implant that needs to be implanted, the size of the implant being in comparison to fusion or tethering hardware, so one (1) or more small incisions can be used for purposes of implanting one (1) or more vertebral implants or variants thereof in accordance with the present invention.Parts List for FIGS. 1 -20(c) vertebral implant magnetic field field lines arrows vertebral implant protrusion vertebral implant taper distal end proximal end vertebra vertebral implants spine vertebral implants field lines subject arrows magnetic field A magnetic field subject spine solenoid coil ends vertical columns arrows magnetic field modified solenoid coilends vertical columns arrows magnetic field magnetic field generator coil ends coil loops vertical columns arrows magnetic field patient magnetic field generator coil ends coil loops columns arrows magnetic field patient coil coil loops coil coil loops coil coil loops magnetic field generator coil inner (first) coil layer outer (second) coil layer magnetic field generator coil / coil loop808 coil / coil loop820 magnetic field824 arrows1000 supporting structure1004 bed surface1008 inner housing layer1009 space1012 outer housing layer1030 patient

[0215] It will be understood that the herein described embodiments of the present invention areexamples. To that end, a number of variations and modifications will be readily apparent to those of sufficient skill in the field that are within the intended scope of these teachings, including the following appended claims.

Claims

Claims:

1. A method for reducing scoliosis deformity, the method comprising: anteriorly implanting one or more vertebral implants within one or more vertebrae of a scoliotic spine; and generating a magnetic field sufficient to induce torques on the one or more vertebral implants.

2. The method according to claim 1 , wherein the generated magnetic field does not induce a substantial net translational force on the one or more vertebral implants.

3. The method according to claim 1, in which the one or more vertebral implants are made from a ferromagnetic material4. The method according to claim 3, wherein at least one vertebral implant is a bolt.

5. The method according to claim 1, in which at least one vertebral implant is implanted in at least one vertebra.

6. The method according to claim 4, in which at least one of the vertebral implants is defined by a taper.

7. The method according to claim 1, further comprising placing a patient within a finite region of the magnetic field.

8. The method according to claim 1, wherein a portion of at least one implanted vertebral implant protrudes outwardly from a vertebra.

9. The method according to claim 1, in which a vertebral implant is disposed such that a major axis of the vertebral implant is substantially parallel with a lateral axis of the vertebra which is implanted.

10. The method according to claim 1, in which the magnetic torques and / or forces can be applied to one or more of the vertebral implants in a patient over more than onesession without further surgery, following implantation of the one or more vertebral implants.

11. An apparatus for reducing scoliotic deformities, the apparatus comprising: a housing; a magnetic field generator partially or fully disposed within the housing and surrounding an internal space sized for receiving a patient, the magnetic field generator being sized and configured for generating a magnetic field around the patient such that the magnetic field will induce torques upon one or more vertebral implants implanted in one or more vertebrae of the patient.

12. The apparatus according to claim 11, wherein the magnetic field generator comprises an electromagnet.

13. The apparatus according to claim 12, wherein the magnetic field generator is a solenoid.

14. The apparatus according to claim 11, wherein the magnetic field generator is a Helmholtz coil.

15. The apparatus according to claim 11, wherein the magnetic field generator is designed to produce a substantially uniform magnetic field within a finite region in and around the patient.

16. The apparatus according to claim 11, wherein the one or more vertebral implants are partially or wholly made of a ferromagnetic material.

17. The apparatus according to claim 11, wherein at least one of the one or more vertebral implants are bolts.

18. The apparatus according to claim 11, wherein the apparatus applies a torque on at least one vertebral implant without simultaneously applying a substantial net translational force.

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