External spinal brace

Abstract

A spinal support system including an interchangeable bushing having different degrees of inclination and a curved sacral segment having various settings. The bushing and the sacral segment may be combined in different ways to collectively produce variable levels of spinal extension and generally apply different forces to the patient's spine as selected by the user.

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims priority to U.S. Provisional Patent Application No. 63 / 390,076, entitled "External Spinal Brace," filed on July 18, 2022, the content of which is incorporated herein by reference. This application claims priority to U.S. Provisional Patent Application No. 63 / 420,962, entitled "External Spinal Brace," filed on October 31, 2022, the content of which is incorporated herein by reference.

[0002] (Technical Field) Embodiments of the present invention are in the field of external spinal braces that apply distraction, bending, and / or torsional forces to a patient's spine.

Background Art

[0003] As defined in U.S. Patent No. 10,206,805, scoliosis is a medical condition in which a person's spinal axis has a three - dimensional deviation. Other disorders associated with abnormalities in spinal alignment include, for example, Scheuermann's kyphosis, congenital scoliosis, neuromuscular diseases, paralysis, dystonia, and spinal injuries. Such disorders have a wide - ranging impact on the entire musculoskeletal system and, in some cases, can cause organ dysfunction. Effective treatment and rehabilitation of such problems require complex treatments that take into account the entire musculoskeletal system and have an impact on the entire musculoskeletal system.

[0004] To treat such spinal diseases, several surgical and non-surgical methods have been attempted. The surgical methods used are generally highly invasive and include, for example, attaching multiple metal rods to the subject's spine using multiple screws. Such highly invasive surgical procedures typically require a long and difficult recovery period.

Summary of the Invention

[0005] The configuration and advantages of the embodiments of the present invention will become apparent from the appended claims, the following detailed description of one or more exemplary embodiments, and the corresponding figures. Where appropriate, reference labels are repeated in the figures to indicate corresponding or similar elements.

Brief Description of the Drawings

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Embodiments for Carrying Out the Invention

[0040] Referring now to the drawings, in the drawings, similar structures may have similar suffix reference designations. To more clearly show the structures of various embodiments, the drawings included in this specification are schematic representations of the structures. Thus, for example, the actual appearance of a manufactured structure in a photograph, while still incorporating the claimed structure of the illustrated embodiment, may look different (e.g., walls may not be exactly orthogonal to each other in an actual manufactured device). Moreover, the drawings may only show structures that are useful for understanding the illustrated embodiments. Additional structures known in the art may not be included to maintain the clarity of the drawings. For example, not every layer of a device is necessarily shown. The “embodiments,” “various embodiments,” etc., as described thus, may include certain features, structures, or characteristics, but not every embodiment necessarily includes the specific features, structures, or characteristics. Some embodiments may have some or all of the configurations described for other embodiments, or may have no configurations described for other embodiments at all. “First,” “second,” “third,” etc., describe common objects and indicate that different instances of similar objects are being referred to. Such adjectives do not imply that the objects so described must be in a given sequence, whether in time, space, ranking, or any other way. “Connected” may indicate that elements are in direct physical, electrical, or magnetic / electromagnetic contact with each other, and “coupled” may indicate that elements are cooperating or interacting with each other, although the elements may or may not be in direct physical or electrical contact. Phrases such as “including at least one of A or B” include the situations of A, B, or both A and B.

[0041] The non-invasive methods determined by the applicant are generally more desirable, but depending on the condition being treated, are limited in success or require external braces that are very restrictive and painful. The applicant further determined that the current rigid braces apply an external force to the ribs of the subject, which restricts the movement of the chest wall and spine and, in some cases, can cause rib deformities. There are some available flexible braces that allow for more freedom of movement. However, the applicant determined that none of the known external braces provide an extension force to the spine, specifically, a posterior extension force, and, in some cases, a posterior extension force combined with flexion and torsion forces.

[0042] Accordingly, the applicant determined that a system and / or method that facilitates the treatment of structural disorders of the spine without invasive techniques or unduly restrictive braces is highly desirable.

[0043] For a better explanation of the composition and operation of the embodiments shown in the figures or discussed herein, examples are taken up.

[0044] Example 1 includes a first vertebral segment (101), a first joint (104) including a first ball and socket joint, a second vertebral segment (102) coupled to the first vertebral segment via the first joint, a second joint (105) including a second ball and socket joint, and a sacral segment (103) coupled to the second vertebral segment via the second joint. A sagittal plane (106) intersects the first and second vertebral segments, the first and second joints, and the sacral segment. A coronal plane (107) intersects one or more of the first and second vertebral segments, the first and second joints, and the sacral segment. The sacral segment includes a first and second ratchet, the first ratchet including a first toothed rack (110) and a first spring-loaded finger (111), and the second ratchet including a second toothed rack (112) and a second spring-loaded finger (113). The first toothed rack includes a first outer surface (114) that curves in the sagittal plane, and the second toothed rack includes a second outer surface (115) that curves in the sagittal plane.

[0045] Elements such as (which may be referred to herein as vertebral segments or support members) 101, 102 are found in part or in whole in FIGS. 1, 4-13. Those figures sometimes deal with various embodiments. Some embodiments are preferred in certain situations, but all such embodiments are implementable embodiments and are the subject matter of the embodiments provided herein. The ratchet may be actuated to increase spinal extension.

[0046] Example 2. The first outer surface is rigid and non-malleable, the system of Example 1.

[0047] Example 3. A system according to any one of Examples 1-2, wherein the second outer surface is rigid and not malleable.

[0048] Example 4. A system according to any one of Examples 1-3, wherein the first outer surface has a first center of curvature (116), and at least a portion of the first toothed rack is between the first outer surface and the first center of curvature.

[0049] The curvature helps to enhance the comfort of the system for the user by better matching the sacral element to the user's back.

[0050] Example 5. A system according to any one of Examples 1-4, comprising a force sensor (117).

[0051] Example 6. The system of Example 5, wherein the second joint is operatively coupled to the force sensor to transmit force from the second joint to the force sensor.

[0052] Example 7. The system of Example 6, wherein the second joint is slidably coupled to the sacral segment (Figure 7).

[0053] Example 8. The system of Example 7, wherein the second joint is not rigidly coupled to the force sensor or the sacral segment.

[0054] Example 9. The system of Example 8, wherein the second joint has one of a male or female coupler (118, 119), and the sacral segment has the other of the male or female coupler of the second joint for slidably and non-rigidly coupling to one of the male or female couplers of the second joint.

[0055] Example 10. The system of Example 7, wherein the first toothed rack includes a void (120) proportioned to receive the force sensor.

[0056] Example 11. The system of Example 7, wherein the force sensor is contained within the void.

[0057] Example 12. A system according to any of Examples 1 - 11, wherein the first toothed rack is slidably coupled to the second toothed rack.

[0058] Example 13. A system according to any of Examples 1 - 12, comprising first opposing support members (121, 122) on opposing side surfaces of a first vertebral segment and second opposing support members (123, 124) on opposing side surfaces of a second vertebral segment.

[0059] Another version of Example 13. A system according to any of Examples 1 - 12, comprising a first number of support members (121, 123) on a first side surface of a first vertebral segment and a second number of support members (122) on a second side surface of the first vertebral segment. The first and second side surfaces are on opposite sides of the first vertebral segment. The first number is not equal to the second number. The total number of support members is arranged asymmetrically with respect to the first vertebral segment.

[0060] Example 13a. A system according to Example 13, configured to provide a flexural force to a patient's spine.

[0061] Example 13b. A system according to Example 13, configured to provide a torsional force to a patient's spine.

[0062] Example 13c. A system according to Example 13, configured to provide a torsional force and a bending force to a patient's spine.

[0063] Example 14. A system according to Example 13, comprising a top brace member (125) and a bottom brace member (126). The sacral segment and the first and second opposing support members are all between the top brace member and the bottom brace member.

[0064] Example 15. A system according to Example 14, wherein the first ratchet is configured to increase the distance between the top brace member and the bottom brace member, thereby providing an extension force to a user of the system.

[0065] Example 16. The first ratchet is configured to increase the distance between the top brace member and the bottom brace member, and as a result, provide a rearward extension force to the user of the system, of the system of Example 14.

[0066] The number of support members (123, 124) may be determined, at least in part, by the size of the individual support members and the length of the subject's torso. The location of the support members is determined by the deformation of the vertebrae to be corrected. The number of support members may be adjusted for the subject as needed (e.g., additional support members as well as vertebral segments 101, 102 may be added as the subject grows).

[0067] In some embodiments, the system may include an attachment system that includes some combination of elements / support members 101, 102, 103, 121, 122, 123, 124, 125, 126. The attachment system may attach (or directly attach) a plurality of support members to the subject such that the plurality of support members are positioned along at least a portion of the subject's vertebrae on the surface of the subject during use. In some embodiments, the attachment system may include a plurality of elongate members 121, 122 coupled (or directly attached) to the plurality of support members 101, 102, 103. The plurality of elongate members may be coupled (or directly attached) to opposite sides of the plurality of support members 101, 102, 103. The plurality of elongate members may be coupled (or directly attached) to the same side, alternating sides, or both sides of adjacent support members. The plurality of elongate members may be wrapped around the subject to attach (or directly attach) the system to the subject during use. The lengths of the plurality of support members may be adjustable with respect to the plurality of support members. The length may be adjustable using buckles, loops, etc. The ability to adjust the length may be beneficial for sizing the system to fit each individual subject in order to adjust the force applied by the elongate members for treatment as the condition of the subject changes. It also allows for adjustment to accommodate the growth of the subject.

[0068] In some embodiments, the system may include one or more elongate members 125, 126 that function to couple (or directly attach) the system to the subject during use. The upper elongate member 125 may function to couple (or directly attach) the system under the subject's axilla or to an upper portion below the subject's scapula. The lower elongate member 126 may function to couple (or directly attach) the system to a lower portion of the subject. The lower elongate member may be positioned around the subject's waist at and / or above the subject's pelvis. The elongate members for coupling may be formed of a substantially flexible and / or rigid material. In some embodiments, the upper elongate member is positioned around an upper portion of the subject's torso during use, and the lower elongate member is positioned around a lower portion of the subject's torso during use. As described above, the members 125, 126 may include belts or other means for attaching the system to the user. For example, FIGS. 2A-3D illustrate means for attaching the system to the user. For example, FIGS. 3C-3D illustrate various straps, panels, belts, etc. for securing the brace to the user, and common clothing (shirts, vests, tanks).

[0069] Example 17. A system according to any of Examples 1-16, wherein when the system is coupled to a user, the sagittal plane intersects at least a portion of the user's spine.

[0070] Example 18. A system according to any of Examples 1-17, wherein the first toothed rack includes a void that includes at least a portion of the second spring-loaded finger.

[0071] Example 19. A system according to any of Examples 1-17, wherein the first toothed rack includes a void that includes at least a portion of at least one of the second spring-biased finger, the second toothed rack, or a combination thereof.

[0072] Another version of Example 1. An external spinal brace system including a first vertebral segment (101), a first joint (104), a second vertebral segment (102) coupled to the first vertebral segment via the first joint, a second joint (105), and a sacral segment (103) coupled to the second vertebral segment via the second joint. A sagittal plane (106) intersects the first and second vertebral segments, the first and second joints, and the sacral segment. A coronal plane (107) intersects one or more of the first and second vertebral segments, the first and second joints, and the sacral segment. The sacral segment includes a first and a second ratchet, the first ratchet including a first toothed rack (110) and a first spring-loaded finger (111), and the second ratchet including a second toothed rack (112) and a second spring-loaded finger (113). The first toothed rack includes a first outer surface (114) that curves in the sagittal plane, and the second toothed rack includes a second outer surface (115) that curves in the sagittal plane.

[0073] Thus, in some embodiments, not all joints are ball and socket joints, and instead, may be other joints (e.g., hinges) that provide various degrees of freedom.

[0074] Another version of Example 1. An external spinal brace system including a first vertebral segment (101), a first joint (104), a second vertebral segment (102) coupled to the first vertebral segment via the first joint, a second joint (105), and a sacral segment (103) coupled to the second vertebral segment via the second joint. A sagittal plane (106) intersects the first and second vertebral segments, the first and second joints, and the sacral segment. A coronal plane (107) intersects one or more of the first and second vertebral segments, the first and second joints, and the sacral segment. The sacral segment includes a first and a second ratchet. The first ratchet includes a first outer surface (114) curved in the sagittal plane, and the second ratchet includes a second outer surface (115) curved in the sagittal plane.

[0075] Thus, in some embodiments, not all ratchets include spring-biased fingers or the like.

[0076] Another version of Example 1. An external spinal brace system including a first vertebral segment (101), a first joint (104) including a first ball and socket joint, a second vertebral segment (102) coupled to the first vertebral segment via the first joint, a second joint (105) including a second ball and socket joint, and a sacral segment (103) coupled to the second vertebral segment via the second joint. A sagittal plane (106) intersects the first and second vertebral segments, the first and second joints, and the sacral segment. A coronal plane (107) intersects one or more of the first and second vertebral segments, the first and second joints, and the sacral segment. The sacral segment includes a first ratchet, and the first ratchet includes a first toothed rack (110) and a first spring-loaded finger. The first toothed rack includes a first outer surface (114) curved in the sagittal plane.

[0077] Thus, not all embodiments include multiple ratchets.

[0078] Example 1a. An external spinal brace system including a first vertebral segment (101), a first joint (104), a second vertebral segment (102) coupled to the first vertebral segment via the first joint, a second joint (105), and a sacral segment (103) coupled to the second vertebral segment via the second joint. A first plane (106) intersects the first and second vertebral portions, the first and second joints, and the sacral segment. A second plane (107) orthogonal to the first plane intersects one or more of the first and second vertebral segments, the first and second joints, and the sacral segment. The sacral segment includes a first and a second ratchet, the first ratchet including a first toothed rack (110) and a first lever (111), and the second ratchet including a second toothed rack (112) and a second lever (113). The first toothed rack includes a first outer surface (114), and the second toothed rack includes a second outer surface (115). At least one of the first or second outer surfaces is curved in the first plane.

[0079] Example 2a. The system of Example 1a, wherein both the first and second outer surfaces are curved in the first plane.

[0080] Example 3a. (a) The second outer surface is rigid and non-malleable, and (b) the first outer surface is rigid and non-malleable, for any of the systems of Example 1a - Example 2a.

[0081] Example 4a. The system of any of Example 1a - Example 3a, wherein the first outer surface has a first center of curvature (116), and at least a portion of the first toothed rack is between the first outer surface and the first center of curvature.

[0082] Example 5a. The system of any of Example 1a - Example 4a, including a force sensor (117).

[0083] Example 6a. The second joint is the system of Example 5a, operatively coupled to the force sensor to transmit force from the second joint to the force sensor.

[0084] Example 7a. The second joint is the system of any one of Examples 1a - 6a, slidably coupled to the sacral segment (Figure 7).

[0085] Example 8a. The second joint is the system of Example 6a, not rigidly coupled to the force sensor or the sacral segment.

[0086] Example 9a. The second joint has one of the male or female couplers (118, 119), and the sacral segment has the other of the male or female couplers to slidably and non - rigidly couple to one of the male or female couplers of the second joint, the system of Example 8a.

[0087] Example 10a. The first toothed rack is the system of Example 6a, including a proportioned gap (120) to receive the force sensor.

[0088] Example 11a. The force sensor is included within the gap, the system of Example 10a.

[0089] Example 12a. The first toothed rack is slidably coupled to the second toothed rack, the system according to any one of Examples 1a - 11a.

[0090] Another version of Example 12a. The first toothed rack is slidably coupled to the second toothed rack and the first toothed rack is in direct contact with the second toothed rack, the system according to any one of Examples 1a - 11a.

[0091] Example 13a. The system according to any one of Examples 1a - 12a, including a first pair of opposing support members (121, 122) on opposing sides of the first vertebral segment and a second pair of opposing support members (123, 124) on opposing sides of the second vertebral segment.

[0092] Another version of Example 13a. A system according to any of Examples 1-12, comprising a first number of support members (121, 123) on a first outer side of a first vertebral segment and a second number of support members (122) on a second outer side of the first vertebral segment. The first and second sides are on both sides of the first vertebral segment. The first number is not equal to the second number. The total number of support members is arranged asymmetrically with respect to the first vertebral segment.

[0093] Example 13a'. The system is the system of Example 13a configured to provide a flexion force to a patient's spine.

[0094] Example 13b'. The system is the system of Example 13a configured to provide a torsional force to a patient's spine.

[0095] Example 13c'. The system is the system of Example 13a configured to provide a torsional force to a patient's spine and a bending force to the patient's spine.

[0096] Example 14a. A system according to Example 13a, including a top brace member (125) and a bottom brace member (126), wherein the sacral segment and the first and second opposing support members are all between the top brace member and the bottom brace member.

[0097] Example 15a. A system according to Example 14a, wherein the first ratchet is configured to increase the distance between the top brace member and the bottom brace member, thereby providing an extension force to a user of the system.

[0098] Example 16a. A system according to Example 14a, wherein the first ratchet is configured to increase the distance between the top brace member and the bottom brace member, thereby providing a posterior extension force to a user of the system.

[0099] Example 17a. A system according to any of Examples 1a-16a, wherein when the system is coupled to a user, a first plane intersects at least a portion of the user's spine.

[0100] Example 18a. A system according to any of Examples 1a - 17a, wherein the first toothed rack includes a gap that includes at least a portion of the second lever.

[0101] Example 19a. A system according to any of Examples 1a - 17a, wherein the first toothed rack includes a gap that includes at least a portion of at least one of the second lever and the second toothed rack.

[0102] Example 20a. A system according to any of Examples 1a - 19a, including a lock for locking the second toothed rack in a stationary position.

[0103] Example 21a. A system according to any of Examples 1a - 20a, wherein the second plane does not intersect each of the first and second vertebral segments, the first and second joints, and the sacral segment.

[0104] Another version of Example 1a. An external spinal brace system including a first vertebral segment (101), a first joint (104), a second vertebral segment (102) coupled to the first vertebral segment via the first joint, a second joint (105), and a sacral segment (103) coupled to the second vertebral segment via the second joint. A first plane (106) intersects the first and second vertebral portions, the first and second joints, and the sacral segment. A second plane (107) orthogonal to the first plane intersects one or more of the first and second vertebral segments, the first and second joints, and the sacral segment. The sacral segment includes a first ratchet that includes a first toothed rack (110) and a first lever (111). The first toothed rack includes a first outer surface (114), and the first outer surface is curved in the first plane.

[0105] Thus, not all embodiments include multiple ratchets.

[0106] Example 1b. An external spinal brace system including a first vertebral segment (201), a first joint (204) including a first ball and socket joint, a second vertebral segment (202) coupled to the first vertebral segment via the first joint, a second joint (205) including a second ball and socket joint coupled to the second vertebral segment, and a first bushing (231) between the first and second vertebral segments. A sagittal plane (206) intersects the first and second vertebral segments, the first and second joints, and the first bushing. A coronal plane (207) intersects one or more of (b)(i) the first and second vertebral segments, (b)(ii) the first and second joints, and (b)(iii) the first bushing. The first bushing includes a superior surface (232) disposed in a first plane of the first bushing and an inferior surface (233) disposed in a second plane of the first bushing. The first plane of the first bushing is not parallel to the second plane of the first bushing.

[0107] For example, refer to FIG. 30(C). Joints 204, 205 are shown in phantom and in some embodiments are similar to the ball and socket joints of FIGS. 12 and 14B. FIG. 32(A) also shows a ball and socket joint. The coronal and sagittal planes are addressed, for example, in FIGS. 38(B) and 38(C).

[0108] As used herein, a bushing is a type of motion resistance resilient member. It provides an interface (interface) between two parts, supports them in an initial relative position, and creates stability in multiple planes and resists motion by providing a reaction force to movement.

[0109] Since the first plane of the first bushing is not parallel to the second plane of the first bushing, the bushing may impart a side bend (i.e., a curve) to the brace or a portion thereof. However, such a non-parallel orientation may instead impart an anterior / posterior bend aspect to the brace or a portion thereof. Additionally, such a non-parallel orientation may impart both a side bend and an anterior / posterior bend to the brace.

[0110] Example 1.1b. The system according to Example 1b, wherein the upper surface is in direct contact with the first vertebral segment.

[0111] For example, refer to FIG. 30(C).

[0112] Example 1.2b. The system according to Example 1.1b, wherein the lower surface is in direct contact with the second vertebral segment.

[0113] For example, refer to FIG. 28(A). However, in other embodiments addressed herein, only one surface of the bushing may be in direct contact with the vertebral segment. For example, refer to FIG. 30(C). In other embodiments, neither surface needs to be in direct contact with the vertebral segment.

[0114] Example 1.3b. The system according to Example 1b, wherein the lower surface is in direct contact with the second vertebral segment.

[0115] Example 2b. A system according to any of Examples 1b to 1.1b, including a sacral segment (103) coupled to a second vertebral segment via a second joint. The sacral segment includes a first and a second ratchet, the first ratchet including a first toothed rack (110) and a first spring-loaded finger (111), and the second ratchet including a second toothed rack (112) and a second spring-loaded finger (113). The first toothed rack includes a first outer surface (114) that curves in the sagittal plane, and the second toothed rack includes a second outer surface (115) that curves in the sagittal plane.

[0116] Thus, in some embodiments, for example, the sacral segment of FIG. 11 may be coupled to a bushing-based embodiment such as the system of FIG. 22A.

[0117] Example 3b. The system of Example 2b, wherein the first outer surface is rigid and non-malleable.

[0118] Example 4b. The system according to any one of Examples 1b to 3b, wherein the second outer surface is rigid and non-malleable.

[0119] Example 5b. The system according to any one of Examples 1b to 4b, wherein the first outer surface has a first center of curvature (116) and at least a portion of the first toothed rack is between the first outer surface and the first center of curvature.

[0120] Example 6b. The system according to any one of Examples 1b to 5b, comprising a force sensor (117).

[0121] Example 7b. The system of Example 6b, wherein the second joint is operatively coupled to the force sensor to transmit force from the second joint to the force sensor.

[0122] Example 8b. The system of Example 7b, wherein the second joint is slidably coupled to the sacral segment (FIG. 7).

[0123] Example 9b. The system of Example 8b, wherein the second joint is not rigidly coupled to the force sensor or the sacral segment.

[0124] Example 10b. The system of Example 9b, wherein the second joint has one of a male or female coupler (118, 119), and the sacral segment has the other of the male or female coupler to slidably and non-rigidly couple to one of the male or female couplers of the second joint.

[0125] Example 11b. The system of Example 8b, wherein the first toothed rack includes a void (120) adapted to receive the force sensor.

[0126] Example 12b. The force sensor is the system of Example 8b contained within the gap.

[0127] Example 13b. The first toothed rack is slidably coupled to the second toothed rack, the system according to any one of Examples 1b to 12b.

[0128] Example 14b. A system according to any one of Examples 1b to 13b, including first opposing support members (121, 122) on opposing side surfaces of a first vertebral segment and second opposing support members (123, 124) on opposing side surfaces of a second vertebral segment.

[0129] Another version of Example 14b. A system according to any one of Examples 1b to 13b, including a first number of support members (121, 123) on a first side surface of a first vertebral segment and a second number of support members (122) on a second side surface of the first vertebral segment. The first and second side surfaces are on both sides of the first vertebral segment. The first number is not equal to the second number. The total number of support members is arranged asymmetrically with respect to the first vertebral segment.

[0130] Example 14b.1. The system is a system according to any one of Examples 1b to 14b, configured to provide a flexion force to a patient's spine.

[0131] Example 14b.2. The system is a system according to any one of Examples 1b to 14b, configured to provide a torsional force to a patient's spine.

[0132] Example 14b.3. The system is a system according to any one of Examples 1b to 14b, configured to provide a torsional force to a patient's spine and to provide a flexion force to a patient's spine.

[0133] Example 15b. The system of Example 14b, including a top brace member (125) and a bottom brace member (126). The sacral segment and the first and second opposing support members are all between the top brace member and the bottom brace member.

[0134] Example 16b. The system of Example 15b, wherein the first ratchet is configured to increase the distance between the top brace member and the bottom brace member, thereby providing an extension force to a user of the system.

[0135] Example 17b. The system of Example 15b, wherein the first ratchet is configured to increase the distance between the top brace member and the bottom brace member, thereby providing a rearward extension force to a user of the system.

[0136] Example 18b. The system according to any one of Examples 1b to 17b, wherein when the system is coupled to a user, the sagittal plane intersects at least a portion of the user's spine.

[0137] Example 19b. The system according to any one of Examples 1b to 18b, wherein the first toothed rack includes a void that includes at least a portion of the second spring load finger.

[0138] Example 20b. The system according to any one of Examples 1b to 18b, wherein the first toothed rack includes a void that includes at least a portion of at least one of the second spring load finger and the second toothed rack.

[0139] Example 1c. The system according to any one of Examples 1b to 1.1b, including a sacral segment coupled to a second vertebral segment via a second joint. The sacral segment includes a first body (4101), a second body (4102) slidably coupled to the first body, and a cord (4103) slidably coupled to at least one of the first or second body.

[0140] For example, refer to FIGS. 41A - 41C. The cord may be, for example, a stainless steel wire cable coated with vinyl. The cable may be, for example, 1 / 16 inch thick.

[0141] Example 2c. The system of Example 1c, wherein the cord is configured to slide the second body away from the first body as the tension on the cord increases.

[0142] For example, when the cord is pulled in one or both directions 4030, 4031, the body 4102 projects upward to increase the user's spinal extension.

[0143] Example 3c. The system according to any of Examples 1c - 2c, wherein the first body includes a slot (4105) and at least a portion of the second body is received within the slot.

[0144] The slot may be closed (like a tunnel) or (at least partially) open as shown in FIG. 41B. The second body may be keyed to the slot via a projection such as projection 4042.

[0145] Example 4c. The system according to any of Examples 1c - 3c, wherein the second joint has one of a male or female coupler (118, 119) and the sacral segment has another one of a male or female coupler (4104) for coupling to one of the male or female couplers of the second joint.

[0146] Example 5c. The system according to any of Examples 1c - 4c, wherein the first body includes a first outer surface (4114) that is curved in the sagittal plane and the second body includes a second outer surface (4115) that is curved in the sagittal plane.

[0147] Thus, in some embodiments, for example, the sacral segment of FIG. 41A may be coupled to a cushioning - based embodiment such as the system of FIG. 22A.

[0148] The curvature helps the sacral segment better conform to the user's lower back.

[0149] Example 6c. The system of Example 5c, wherein the first outer surface is rigid and non-malleable.

[0150] Example 7c. The system according to any one of Examples 5c to 6c, wherein the second outer surface is rigid and non-malleable.

[0151] Example 8c. The system according to any one of Examples 5c to 7c, wherein the first outer surface has a first center of curvature, and at least a portion of the second body is between the first outer surface and the first center of curvature.

[0152] Example 9c. The system according to any one of Examples 1c to 8c, including a force sensor.

[0153] Example 10c. The system of Example 9c, wherein the second joint is operatively coupled to the force sensor so as to transmit a force from the second joint to the force sensor.

[0154] Example 11c. The system according to any one of Examples 1c to 10c, wherein the second joint is slidably coupled to the sacral segment.

[0155] Example 12c. The system of Example 11c, wherein the second joint is not rigidly coupled to the force sensor or the sacral segment.

[0156] Example 13c. The system of Example 9c, wherein the second body includes a cavity adapted to receive the force sensor.

[0157] Example 14c. The system of Example 13c, wherein the force sensor is contained within the cavity.

[0158] Example 15c. The system according to any one of Examples 1c to 14c, including first opposing support members (121, 122) on opposing side surfaces of the first vertebral segment and second opposing support members (123, 124) on opposing side surfaces of the second vertebral segment.

[0159] Another version of Example 15c. A system according to any of Examples 1c to 14c, comprising a first number of support members (121, 123) on a first side of a first vertebral segment and a second number of support members (122) on a second side of the first vertebral segment. The first and second sides are on opposite sides of the first vertebral segment. The first number is not equal to the second number. The total number of support members is arranged asymmetrically with respect to the first vertebral segment.

[0160] Example 16c. A system according to any of Examples 1c to 15c, configured to provide a flexion force to a patient's spine.

[0161] Example 17c. A system according to any of Examples 1c to 16c, configured to provide a torsional force to a patient's spine.

[0162] Example 18c. A system according to Example 15c, including a top brace member (125) and a bottom brace member (126), wherein the sacral segment and the first and second opposing support members are all between the top brace member and the bottom brace member.

[0163] Example 19c. A system according to Example 18c, wherein the cord is configured to increase the distance between the top brace member and the bottom brace member, such that when the tension on the cord increases, an extension force is provided to the user of the system.

[0164] Example 20c. A system according to Example 19c, wherein the extension force is a posterior extension force.

[0165] Example 21c. A system according to any of Examples 1c to 20c, wherein when the system is coupled to a user, the sagittal plane intersects at least a portion of the user's spine.

[0166] Example 22c. A system according to any of Examples 1c to 20c, including an arcuate channel (4021), wherein the cord is contained within the arcuate channel.

[0167] For example, refer to the arcuate portions 4032, 4033.

[0168] Example 23c. The code exits the sacral segment at the first location (4022), a system according to any of Examples 1c - 22c.

[0169] Example 24c. The code exits the sacral segment at the second location (4023), a system according to Example 23c.

[0170] However, also refer to locations 4034, 4035. The code may vary the amount of force added to the code to move the second body by exiting from these positions instead of locations 4022, 4023.

[0171] Example 25c. Includes a first plane (4024) orthogonal to a second plane (4025), the first plane intersecting the code at least three times, a system according to any of Examples 1c - 24c.

[0172] The arcuate path of the code provides a mechanical advantage that magnifies any force that increases the tension in the code, such as when the code is pulled in directions 4030 and / or 4031, as shown in FIG. 39 or FIG. 42A.

[0173] By positioning the pivot point (pivoting point) as shown in embodiments (e.g., FIGS. 39 and 41B), a pulley - like pivot point may provide, for example, a reduction in force by a factor of 1 / 6. In one embodiment, when the code is pulled 6 inches, the second body slides 2 inches upward. Although the actual pulley is not shown, other embodiments may include one or more pulleys. Further, with respect to the mechanical advantage described above, by placing pivot points in the upper and lower portions of the sacral element, the force vector applied to the second body (due to the increased tension on the code) is more vertical and thus more efficient.

[0174] In one embodiment, the bending radius (e.g., bending radius 4041) may be configured to avoid binding of the cord. The radius may vary, but for example, may be 0.41 inches.

[0175] Example 26c. The system according to Example 25c, wherein the first plane intersects the cord at least four times.

[0176] Example 27c. The system according to any one of Examples 25c to 26c, wherein the second plane intersects the cord at least twice.

[0177] Example 28c. The system of Example 27c, wherein the second plane intersects the cord at least three times.

[0178] Example 29c. The system according to any one of Examples 1c to 28c, wherein the side wall of the sacral segment tapers inwardly (narrows) as the side wall extends away from the first vertebral segment.

[0179] This tapering helps to enhance the comfort of the user's lumbar region where the back interfaces with the sacral element. Further, any reduction in material also helps to reduce the overall weight of the system, which also increases comfort for the user.

[0180] Example 30c. The system of Example 1c includes a first pivot point (4026), a second pivot point (4027), and a third pivot point (4028), and the cord wraps around a portion of the first pivot point, a portion of the second pivot point, and a portion of the third pivot point.

[0181] For example, refer to FIGS. 39 and 40B.

[0182] Example 31c. The system of Example 30c, wherein the first and third pivot points are included in the first body and the second pivot point is included in the second body.

[0183] Another version of Example 1b. An external spinal brace system comprising a first vertebral segment (101), a first joint (104), a second vertebral segment (102) coupled to the first vertebral segment via the first joint, a second joint (105), and a sacral segment (103) coupled to the second vertebral segment via the second joint. A sagittal plane (106) intersects the first and second vertebral segments, the first and second joints, and the sacral segment. A coronal plane (107) intersects one or more of (b)(i) the first and second vertebral segments, (b)(ii) the first and second joints, and (b)(iii) the sacral segment. The sacral segment includes a first and a second ratchet, the first ratchet including a first toothed rack (110) and a first spring-loaded finger (111), and the second ratchet including a second toothed rack (112) and a second spring-loaded finger (113). The first toothed rack includes a first outer surface (114) that curves in the sagittal plane, and the second toothed rack includes a second outer surface (115) that curves in the sagittal plane.

[0184] Another version of Example 1b. An external spinal brace system including a first vertebral segment (201), a first joint (204), a second vertebral segment (202) coupled to the first vertebral segment via the first joint, a second joint (205), and a bushing (231) between the first vertebral segment and the second vertebral segment. A sagittal plane (206) intersects the first and second vertebral segments, the first and second joints, and the bushing. A coronal plane (207) intersects one or more of (b)(i) the first and second vertebral segments, (b)(ii) the first and second joints, and (b)(iii) the bushing. The bushing includes an upper surface (232) disposed in a first plane of the first bushing and a lower surface (233) disposed in a second plane of the first bushing, and the first plane of the first bushing is not parallel to the second plane of the first bushing. Such an upper surface is also shown, for example, in FIG. 24A. The lower surface is not explicitly shown in FIG. 24A (at least in its entirety). Of course, in other embodiments, the surfaces may not be completely flat and may not even be partially flat. For example, the surfaces may be knobbed or may have some other pattern on the surface. Nevertheless, the surfaces of the bushing (lower and / or upper) may still provide a general tilt angle that imparts a desired force to the patient's spine.

[0185] Thus, in some embodiments, not all joints are ball and socket joints, but instead may be other joints (e.g., hinges) that provide various degrees of freedom.

[0186] Example 21b. A system according to any of Examples 1b - 20b, comprising a third vertebral segment (243) coupled to a second vertebral segment via a second joint, and a second cushioning (244) between the second vertebral segment and the third vertebral segment. The second cushioning includes an upper surface (245) disposed in a first plane of the second cushioning and a lower surface (246) disposed in a second plane of the second cushioning. The first plane of the second cushioning is parallel to the second plane of the second cushioning.

[0187] For example, refer to FIG. 28B including the first cushioning 231'. Since the first plane of the second cushioning is parallel to the second plane of the second cushioning, the second cushioning does not cause lateral bending or anterior / posterior bending. Still, the cushioning may include an elastic material (e.g., rubber, polyurethane, silicone) that provides stability and general movement resistance.

[0188] Example 22b. A system according to any of Examples 1b - 20b, comprising a third vertebral segment (243) coupled to a second vertebral segment via a second joint, and a second cushioning between the second vertebral segment and the third vertebral segment. The second cushioning includes an upper surface disposed in a first plane of the second cushioning and a lower surface disposed in a second plane of the second cushioning. The first plane of the second cushioning is not parallel to the second plane of the second cushioning.

[0189] In some embodiments, the second cushioning does not impart lateral bending or anterior / posterior bending, but in other embodiments, the second cushioning imparts lateral bending and / or anterior / posterior bending in addition to any lateral bending and / or anterior / posterior bending imparted by the first cushioning.

[0190] Example 23b. A system according to any of Examples 21b - 22b, wherein the first plane of the first cushioning is not parallel to the first plane of the second cushioning.

[0191] Thus, embodiments may include bushings having different angles, which, when combined, may impart lordosis / kyphosis and / or scoliosis to the brace and subsequent patient. For example, refer to the bushings of FIGS. 25A and 25B.

[0192] Example 24b. A system according to Example 23b, wherein a first plane of a first bushing has a first degree of angle in the coronal plane, a first plane of a second bushing has a second degree of angle in the coronal plane, and the first degree of angle in the coronal plane is not equal to the second degree of angle in the coronal plane.

[0193] Example 24.1b. A system according to Example 23b, wherein a first bushing is configured to impart a first degree of scoliosis, a second bushing is configured to impart a second degree of scoliosis, and the first and second degrees of scoliosis are not equal to each other.

[0194] In some embodiments, the corresponding angles of the first and second bushings may be different or the same. For example, the configuration may have continuous bushings with a 5-degree scoliosis. The configuration may have continuous bushings with a 5-degree lordosis. In one embodiment, the first degree of angle may be equal to the second degree of angle, and the first and second degrees of scoliosis may be equal to each other. This also applies to embodiments addressing lordosis / kyphosis.

[0195] Example 25b. A system according to any of Examples 23b - 24.1b, wherein a first plane of a first bushing has a first degree of angle in the sagittal plane, a first plane of a second bushing has a second degree of angle in the sagittal plane, and the first degree of angle in the sagittal plane is not equal to the second degree of angle in the sagittal plane.

[0196] Example 25.1b. A system according to any of Examples 23b - 24.1b, wherein a first bushing is configured to impart a first degree of lordosis, a second bushing is configured to impart a second degree of lordosis, and the first degree of lordosis is not equal to the second degree of lordosis.

[0197] In many places in this specification, the term "antero-posterior curve" is used to indicate the degree of inclination in the sagittal plane, regardless of whether the brace is oriented to provide an antero-posterior curve. In many places in this specification, the term "lateral curve" is used to indicate the degree of inclination in the coronal plane, regardless of whether the brace is oriented to provide a lateral curve.

[0198] Example 26b. A system according to any of Examples 23b - 24b, wherein a first plane of a first bushing has a first degree of angle in the sagittal plane, a first plane of a second bushing has a second degree of angle in the sagittal plane, and the first degree of antero-posterior curve is not equal to the second degree of angle in the sagittal plane.

[0199] As used herein, an antero-posterior curve is described as a positive angle in the sagittal plane and an anterior curve is described as a negative angle in the sagittal plane.

[0200] For example, FIGS. 25(A)-(C) show bushings that include various combinations of lateral and antero-posterior curve inductions. For example, FIG. 25(C) shows that no lateral curve is induced but an antero-posterior curve is induced, while FIG. 25(A) shows the induction angles for both lateral and antero-posterior curves.

[0201] Example 26.1b. A system according to any of Examples 23b - 24b, wherein a first bushing is configured to impart a first degree of antero-posterior curve and a second bushing is configured to impart a second degree of antero-posterior curve, and the first degree of antero-posterior curve is not equal to the second degree of antero-posterior curve.

[0202] Example 27b. The first bushing is a system according to any of Examples 1b - 26b, including a first protrusion (2901), a second protrusion (2902), a third protrusion (2903), and a fourth protrusion (2904). The first vertebral segment includes a first and a second gap, and the second vertebral segment includes a first and a second gap. The first protrusion is contained within the first gap of the first vertebral segment, and the second protrusion is contained within the second gap of the first vertebral segment. The third protrusion is contained within the first gap of the second vertebral segment, and the fourth protrusion is contained within the second gap of the second vertebral segment.

[0203] For example, refer to FIG. 29A for the protrusions and FIG. 37 for the gaps. For example, the gaps 3701, 3702, 3703, 3704 are configured to receive the bushing protrusions. Other embodiments may include one, two, three, five, or more protrusions to similarly couple the bushing to the vertebral segment. Similarly, the bushing may alternatively include gaps for receiving anchor protrusions from adjacent vertebral segments.

[0204] Other coupling mechanisms are envisioned, such as other male / female couplers for coupling the bushing to the vertebral segment. The embodiments addressed herein enable compression / decompression and modular systems, and the components of the modular system may be exchanged with each other to provide various configurations of lateral bending and / or anterior / posterior bending.

[0205] Example 28b. The first bushing is a system according to any of Examples 1b - 27b, including a hole that couples the upper surface of the first bushing to the lower surface of the first bushing. The hole has a first maximum width where the hole interfaces with the upper surface of the first bushing. The hole has a second maximum width where the hole interfaces with the lower surface of the first bushing. The first maximum width is greater than the second maximum width.

[0206] Another version of Example 28b. The first vertebral segment is a system according to any of Examples 1b - 27b having a lower surface that includes a first aperture. The second vertebral segment has an upper surface that includes a second aperture. The first aperture has a first maximum width (3710) where the first aperture interfaces with the lower surface of the first vertebral segment, and the second aperture has a second maximum width (3711) where the second aperture interfaces with the upper surface of the second bushing, and the first maximum width is greater than the second maximum width.

[0207] Thus, in one embodiment, the apertures in the bushing (including the rod coupled to the first and second apertures) may or may not have the same dimensions at their top and bottom.

[0208] For example, refer to FIG. 37. The unequal widths allow the rod to mate with bushings having various degrees of lateral bend (i.e., inclination in the coronal plane) between them, while allowing movement without resistance (lateral flexion) in the coronal plane and resisting flexion (flexion / extension) in the sagittal plane and torsion (rotation) in the axial plane.

[0209] Example 29b. A system according to Example 28b that includes a rod (3712). The first vertebral segment includes an aperture. The second vertebral segment includes an aperture. The rod is included in the aperture of the first vertebral segment, the aperture of the second vertebral segment, and the aperture of the first bushing.

[0210] For example, referring to FIG. 37, the rod provides stability to the system (e.g., prevents buckling), increases torsional resistance, and increases bending resistance in the sagittal plane but not in the coronal plane, and does not affect the intended lateral and / or lordotic / kyphotic bending by one or more bushings. The width 3710 (width of the lower hole of the first vertebral segment) is greater than the width 3711 (width of the upper hole of the second vertebral segment), so the rod 3712 engages with the first vertebral segment despite the lateral bending of the bushing. In various embodiments, one or more such rods or support members may be used to stabilize the brace system.

[0211] FIG. 33 shows, in one embodiment, how multiple rods are used to stabilize multiple segments. The rods are non-monolithic and are separated from each other, for example, by space 3301. Such a space allows for compression / decompression within the brace and between the rods.

[0212] The rod may be somewhat flexible to allow for limited movement of the brace. The rod may be formed of nylon, polyurethane, or the like.

[0213] Example 30b. A system according to any of Examples 1b - 29b, wherein the first vertebral segment includes a maximum width, the first bushing includes a maximum width, and the maximum width of the first vertebral segment is equal to the maximum width of the first bushing.

[0214] For example, refer to width 3101 in FIG. 31.

[0215] Example 31b. A system according to any of Examples 1b - 30b, wherein the first vertebral segment includes a maximum width, the first bushing includes a maximum width, and the maximum width of the first vertebral segment is not equal to the maximum width of the first bushing.

[0216] For example, refer to widths 3002 and 3001 of FIG. 30. FIG. 30 discloses a bushing that is a wedge (cuneus) having less width than the vertebral segment thereon.

[0217] Example 32b. A system according to Example 31b, including a second bushing (234) between a first vertebral segment and a second vertebral segment, the second bushing including a maximum width, and the maximum width of the first bushing not being equal to the maximum width of the second bushing.

[0218] For example, in FIG. 30A, multiple bushings of different widths are used to obtain a desired level of scoliosis. Thus, more than one bushing may be included between vertebral segments. Further, although different widths were addressed immediately above, in other embodiments, multiple bushings of different dimensions (not limited to width) are used to obtain a desired level of curvature.

[0219] Example 33b. A system according to any of Examples 1b - 32b, wherein a first portion of a first joint is included in a first vertebral segment, a second portion of the first joint is included in a second vertebral segment, and a third portion of the first joint is included in a first bushing.

[0220] For example, refer to FIG. 32(A).

[0221] Example 34b. A system according to any of Examples 1b - 33b, wherein a first joint is slidably coupled to a first and a second vertebral segment.

[0222] For example, FIG. 32(A) shows how joint 3201 includes hole 3202 for receiving anchor 3203. Hole 3202 is wide enough to slide the joint relative to anchor 3203 to accommodate compression / decompression of the brace. Also refer to gap 3204 that allows joint 3201 to slide. However, in other embodiments, anchor 3203 does not slide. In other words, spaces 3202 and / or 3204 may cooperate to allow movement of elements relative to each other, such as element 3201 relative to element 3203. Joint 3201 may be considered to include, in one embodiment, a multi-axis post and vertebral segment that it is received by, or more generally, that it is coupled to.

[0223] Example 41b. An external spinal brace system comprising a first vertebral segment (201), a first joint (204) including a first ball and socket joint, a second vertebral segment (202) coupled to the first vertebral segment via the first joint, a first bushing (231) coupling the first and second vertebral segments to each other in a first configuration, and a second bushing coupling the first and second vertebral segments to each other in a second configuration. In the first configuration, (a) the sagittal plane intersects the first and second vertebral segments, the first and second joints, and the first bushing, and (b) the coronal plane intersects one or more of (b)(i) the first and second vertebral segments, (b)(ii) the first and second joints, and (b)(iii) the first bushing. In the second configuration, (a) the sagittal plane intersects the first and second vertebral segments, the first and second joints, and the first bushing, and (b) the coronal plane intersects one or more of the first and second vertebral segments, the first and second joints, and the second bushing. The first bushing includes an upper surface disposed in a first plane of the first bushing and a lower surface disposed in a second plane of the first bushing. The first and second planes of the first bushing intersect at a first angle of incidence. The second bushing includes an upper surface disposed in a first plane of the second bushing and a lower surface disposed in a second plane of the second bushing. The first and second planes of the second bushing intersect at a second angle of incidence. The first and second angles of incidence are not equal to each other.

[0224] For example, in FIG. 25, the first bushing may include an angle of incidence of 10 degrees for lateral bending and the second bushing may include an angle of incidence of 5 degrees for lateral bending. The user may select which of the bushings to use in an interchangeable format to achieve a desired level of lateral bending. This kit of multiple interchangeable bushings enables the user to customize the brace system according to the patient's needs.

[0225] In one embodiment, the first and second incident angles are not equal to each other, and in another embodiment, the first and second incident angles are equal to each other.

[0226] Example 42b. An external spinal brace system including a first vertebral segment (201), a first joint (204) including a first ball and socket joint, a second vertebral segment (202) coupled to the first vertebral segment via the first joint, a second joint (205) including a second ball and socket joint coupled to the second vertebral segment, and a first cushioning (231) between the first and second vertebral segments. A sagittal plane (206) intersects the first and second vertebral segments, the first and second joints, and the first cushioning. A coronal plane (207) intersects (b)(i) one or more of the first and second vertebral segments, (b)(ii) the first and second joints, and (b)(iii) the first cushioning. The first cushioning includes first and second surfaces oriented relative to each other to provide a first degree of lateral curvature to the system.

[0227] Example 43b. A system according to Example 42b, including a second cushioning including first and second surfaces oriented relative to each other to provide a second degree of lateral curvature to the system when exchanged with the first cushioning. The first and second degrees of lateral curvature are not equal to each other.

[0228] Example 1d. A first vertebral segment (201), a first joint (204), a second vertebral segment (202) coupled to the first vertebral segment via the first joint, a second joint (205) coupled to the second vertebral segment, and a first modular spacer (231) between the first and second vertebral segments, wherein (a) a sagittal plane (206) intersects the first and second vertebral segments, the first and second joints, and a first cushioning, and (b) a coronal plane (207) intersects (b)(i) the first and second vertebral segments, (b)(ii) the first and second joints, (b)(iii) the first modular spacer, or (b)(iv) one or more of their combinations, an external spinal brace system. The first modular spacer is non-linear and includes an upper surface (232) that is not parallel to the lower surface (233) of the first modular spacer.

[0229] Example 2d. A system according to Example 1d, including a third vertebral segment (243) coupled to the second vertebral segment via the second joint and a second modular spacer (244) between the second and third vertebral segments. The second modular spacer is linear and includes an upper surface (245) parallel to the lower surface (246) of the second spacer.

[0230] Example 3d. A system according to Example 1d, including a third vertebral segment (243) coupled to the second vertebral segment via the second joint and a second modular spacer between the second and third vertebral segments. The second modular spacer is not linear and includes an upper surface that is not parallel to the lower surface of the second modular spacer.

[0231] The spacers are "modular" in that they can be mixed and matched by the user to achieve the appropriate forces to be applied to the patient.

[0232] The foregoing description of embodiments of the present invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise forms disclosed. The terms left, right, top, bottom, up, down, upper, lower, first, second, etc., as used in this specification and the following claims are for descriptive purposes only and are not to be construed as limiting. For example, terms indicating relative vertical position refer to situations where the side of a substrate is the "top" surface of that substrate. Since the substrate may actually be in any orientation, the "top" side of the substrate may be below the "bottom" side within a standard terrestrial reference frame and still be within the meaning of "top". As used in this specification (including the claims), the term "on" does not indicate that a first layer "on" a second layer is immediately above and in direct contact with the second layer unless specifically stated otherwise. There may be a third layer or other structure between the first layer and the second layer above the first layer. Embodiments of the devices or articles described herein can be manufactured, used, or transported in a number of positions and orientations. One of ordinary skill in the art will appreciate that many modifications and variations are possible in light of the above teachings. One of ordinary skill in the art will recognize various equivalent combinations and substitutions of the various components shown in the figures. Accordingly, the scope of the present invention is intended to be limited not by this detailed description, but by the claims appended hereto.

Claims

1. a first vertebral segment, a first joint, a second vertebral segment coupled to the first vertebral segment via the first joint, a second joint coupled to the second vertebral segment, a first cushioning between the first vertebral segment and the second vertebral segment, wherein (a) a sagittal plane intersects the first and second vertebral segments, the first and second joints, and the first cushioning, and (b) a coronal plane intersects one or more of (b)(i) the first and second vertebral segments, (b)(ii) the first and second joints, (b)(iii) the first cushioning, or (b)(iv) a combination thereof; wherein (a) the first cushioning includes an upper surface disposed in a first plane of the first cushioning and a lower surface disposed in a second plane of the first cushioning, and (b) the first plane of the first cushioning is not parallel to the second plane of the first cushioning; an external spinal brace system.

2. The external spinal brace system according to claim 1, wherein the upper surface directly contacts the first vertebral segment.

3. The external spinal brace system according to claim 2, wherein the lower surface directly contacts the second vertebral segment.

4. a third vertebral segment coupled to the second vertebral segment via the second joint, a second cushioning between the second vertebral segment and the third vertebral segment, wherein (a) the second cushioning includes an upper surface disposed in a first plane of the second cushioning and a lower surface disposed in a second plane of the second cushioning, and (b) the first plane of the second cushioning is parallel to the second plane of the second cushioning; The external spinal brace system according to claim 1.

5. a third vertebral segment coupled to the second vertebral segment via the second joint, a second cushioning between the second vertebral segment and the third vertebral segment, wherein (a) the second cushioning includes an upper surface disposed in a first plane of the second cushioning and a lower surface disposed in a second plane of the second cushioning, and (b) the first plane of the second cushioning is not parallel to the second plane of the second cushioning; The external spinal brace system according to claim 1.

6. The external spinal brace system according to any one of claims 4 or 5, wherein the first plane of the first bushing is not parallel to the first plane of the second bushing.

7. The first plane of the first bushing has an angle of a first degree in the coronal plane, The first plane of the second bushing has an angle of a second degree in the coronal plane, The angle of the first degree in the coronal plane is not equal to the angle of the second degree in the coronal plane, The external spinal brace system according to any one of claims 4 or 5.

8. The first bushing is configured to provide a first degree of lateral curvature, The second bushing is configured to provide a second degree of lateral curvature, The first and second degrees of lateral curvature are not equal to each other, The external spinal brace system according to any one of claims 4 or 5.

9. The first plane of the first bushing has an angle of a first degree in the sagittal plane, The first plane of the second bushing has an angle of a second degree in the sagittal plane, The angle of the first degree in the sagittal plane is not equal to the angle of the second degree in the sagittal plane, The external spinal brace system according to any one of claims 4 or 5.

10. The first bushing is configured to provide a first degree of lordosis, The second bushing is configured to provide a second degree of lordosis, The first degree of lordosis is not equal to the second degree of lordosis, The external spinal brace system according to any one of claims 4 or 5.

11. The first bushing is configured to provide a first degree of kyphosis, The second bushing is configured to provide a second degree of kyphosis, The first degree of kyphosis is not equal to the second degree of kyphosis, The external spinal brace system according to any one of claims 4 or 5.

12. The first bushing includes a first protrusion, a second protrusion, a third protrusion, and a fourth protrusion, The first vertebral segment includes first and second gaps, and the second vertebral segment includes first and second gaps, The first protrusion is included in the first gap of the first vertebral segment, and the second protrusion is included in the second gap of the first vertebral segment, The third protrusion is included in the first gap of the second vertebral segment, and the fourth protrusion is included in the second gap of the second vertebral segment. The external spinal brace system according to any one of claims 4 or 5.

13. The first bushing includes a hole that connects the upper surface of the first bushing to the lower surface of the first bushing. The hole has a first maximum width at which the hole interfaces with the upper surface of the first bushing. The hole has a second maximum width at which the hole interfaces with the lower surface of the first bushing. The first maximum width is greater than the second maximum width. The external spinal brace system according to any one of claims 4 or 5.

14. Including a rod. The first vertebral segment includes a hole having a first maximum width. The second vertebral segment includes a hole having a second maximum width that is not equal to the first maximum width of the hole of the first vertebral segment. The rod is included in the hole of the first vertebral segment, the hole of the second vertebral segment, and the hole of the first bushing. The external spinal brace system according to any one of claims 4 or 5.

15. The first vertebral segment includes a maximum width. The first bushing includes a maximum width. The maximum width of the first vertebral segment is equal to the maximum width of the first bushing. The external spinal brace system according to any one of claims 4 or 5.

16. The first vertebral segment includes a maximum width. The first bushing includes a maximum width. The maximum width of the first vertebral segment is not equal to the maximum width of the first bushing. The external spinal brace system according to any one of claims 4 or 5.

17. The first bushing includes a maximum width. The second bushing includes a maximum width. The maximum width of the first bushing is not equal to the maximum width of the second bushing. The external spinal brace system according to any one of claims 4 or 5.

18. The first part of the first joint is included in the first vertebral segment. The second part of the first joint is included in the second vertebral segment. The third part of the first joint is included in the first bushing. The external spinal brace system according to any one of claims 4 or 5.

19. Including a sacral segment coupled to the second vertebral segment via the second joint, The sacral segment includes a first ratchet and a second ratchet, the first ratchet includes a first toothed rack and a first spring-loaded finger, and the second ratchet includes a second toothed rack and a second spring-loaded finger, The first toothed rack includes a first outer surface curved in the sagittal plane, and the second toothed rack includes a second outer surface curved in the sagittal plane, The external spinal brace system according to any one of claims 4 or 5.

20. The external spinal brace system according to claim 19, wherein the first outer surface is rigid and non-malleable, and the second outer surface is rigid and non-malleable.

21. The external spinal brace system according to claim 20, wherein the first outer surface has a first center of curvature, and at least a portion of the first toothed rack is between the first outer surface and the first center of curvature.

22. The external spinal brace system according to claim 21, including a force sensor.

23. The external spinal brace system according to claim 22, wherein the second joint is operatively coupled to the force sensor to transmit force from the second joint to the force sensor.

24. The external spinal brace system according to claim 21, wherein the second joint is slidably coupled to the sacral segment.

25. The external spinal brace system according to claim 24, wherein the second joint has one of a male or female coupler, and the sacral segment has another one of the male or female couplers of the second joint to slidably and non-rigidly couple to one of the male or female couplers of the second joint.

26. The external spinal brace system according to claim 21, wherein the first toothed rack is slidably coupled to the second toothed rack.

27. The external spinal brace system according to claim 21, including a top brace member and a bottom brace member separated from each other by a certain distance, and the first vertebral segment is between the top brace member and the bottom brace member.

28. The first ratchet is configured to increase the distance between the top brace member and the bottom brace member, and as a result, provide a rearward extension force to a user of the external spinal brace system, according to the external spinal brace system of claim 27.

29. The first toothed rack includes a gap, and the gap includes at least a portion of the second spring load finger, according to the external spinal brace system of claim 21.

30. The first toothed rack includes a gap, and the gap includes at least a portion of at least one of the second spring load finger and the second toothed rack, according to the external spinal brace system of claim 21.

31. A first pair of opposing support members on opposing side surfaces of the first vertebral segment, A second pair of opposing support members on opposing side surfaces of the second vertebral segment, including, The external spinal brace system according to any one of claims 4 or 5.

32. The external spinal brace system is configured to provide a flexion force to a patient's spine, according to the external spinal brace system of any one of claims 4 or 5.

33. The external spinal brace system is configured to provide a torsional force to a patient's spine, according to the external spinal brace system of any one of claims 4 or 5.

34. The external spinal brace system is configured to provide a torsional force to a patient's spine and a flexion force to a patient's spine, according to the external spinal brace system of any one of claims 4 or 5.

35. When the external spinal brace system is coupled to a user's spine, the sagittal plane intersects at least a portion of the user's spine, according to the external spinal brace system of any one of claims 4 or 5.

36. Including a sacral segment coupled to the second vertebral segment via the second joint, The sacral segment includes a first body, a second body slidably coupled to the first body, and a cord slidably coupled to at least one of the first body or the second body, The external spinal brace system according to any one of claims 4 or 5.

37. The external spinal brace system according to claim 36, wherein the cord is configured to slide the second body away from the first body when the tension on the cord increases. **Claim 38** The external spinal brace system according to claim 37, wherein the first body includes a slot and at least a portion of the second body is included within the slot. **Claim 39** The external spinal brace system according to claim 38, wherein the second joint has one of a male or female coupler, and the sacral segment has another one of the male or female couplers of the second joint to couple to one of the male or female couplers of the second joint. **Claim 40** The external spinal brace system according to claim 36, wherein the first body includes a first outer surface that curves in the sagittal plane, and the second body includes a second outer surface that curves in the sagittal plane. **Claim 41** The external spinal brace system according to claim 40, wherein the first outer surface has a first center of curvature, and at least a portion of the second body is between the first outer surface and the first center of curvature. **Claim 42** Including a top brace member and a bottom brace member separated from each other by a certain distance, wherein the first vertebral segment is between the top brace member and the bottom brace member, and the cord is configured to increase the distance between the top brace member and the bottom brace member, so that the tension on the cord increases, and when a user is coupled to the external spinal brace system, the external spinal brace system provides an extension force to the user. The external spinal brace system according to claim 41. **Claim 43** The external spinal brace system according to claim 42, wherein the extension force is an extension force on a rear portion of the user of the external spinal brace system. **Claim 44** The external spinal brace system according to claim 36, wherein when the external spinal brace system is coupled to a user's spine, the sagittal plane intersects at least a portion of the user's spine. **Claim 45** The external spinal brace system according to claim 36, including an arcuate channel, and the cord is included within the arcuate channel. **Claim 46** The external spinal brace system according to claim 36, wherein the cord exits the sacral segment at a first location. **Claim 47** The external spinal brace system according to claim 46, wherein the cord exits the sacral segment at a second location. **Claim 48** The external spinal brace system according to claim 36, comprising a first plane orthogonal to a second plane, the first plane intersecting the cord at least three times. **Claim 49** The external spinal brace system according to claim 48, wherein the second plane intersects the cord at least twice. **Claim 50** The external spinal brace system according to claim 36, wherein the side walls of the sacral segment taper inward as the side walls extend away from the first vertebral segment. **Claim 51** The external spinal brace system according to claim 36, comprising a first pivot point, a second pivot point, and a third pivot point, the cord wrapping around a portion of the first pivot point, a portion of the second pivot point, and a portion of the third pivot point. **Claim 52** The external spinal brace system according to claim 51, wherein the first pivot point and the third pivot point are included in the first body, and the second pivot point is included in the second body.

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