INTERNAL ELASTIC BRACE FOR TREATING SCOLIOSIS

Abstract

Certain embodiments are directed to a scoliosis treatment device, an internal elastic brace (IEB) for scoliosis, and methods of using or deploying the same to treat scoliosis. The scoliosis treatment device includes various components that are assembled and deployed to provide a compressive force to the convex side of an abnormally curved spine by tethering the ribs on the convex side of the spinal curvature.

Claims

1. A kit for assembly of an internal elastic brace for the treatment of scoliosis comprising: (a) a first and second rib attachment anchor; and (b) a rib attachment tether, wherein the components are configure for a first end of the rib attachment tether to be anchored to a first rib by a first rib attachment anchor and the second end of the rib attachment tether to be anchored to a second rib by a second rib attachment anchor to tether the first and second rib providing a compressive force to the spine or vertebrae located with the abnormal curvature.

2. A method of deploying the kit of claim 1 comprising: (a) forming a lumen in a first and second rib; (b) positioning a first end of a rib tether through the lumen in a first rib; (c) securing the rib tether to a first rib attachment anchor; (d) positing a second end of the rib tether through the lumen in a second rib; and (e) securing the rib tether to a second rib attachment anchor.

3. The method of claim 2, wherein the first second rib are non-adjacent ribs.

Description

DESCRIPTION OF THE DRAWINGS

[0021] The following drawings form part of the present specification and are included to further demonstrate certain aspects of the present invention. The invention may be better understood by reference to one or more of these drawings in combination with the detailed description of the specification embodiments presented herein.

[0022] FIG. 1. Illustration of the IEB deployed and in operation.

[0023] FIG. 2. Illustration of the anchor and its interface with an intervening segment or tether.

DESCRIPTION

[0024] The following discussion is directed to various embodiments of the invention. The term “invention” is not intended to refer to any particular embodiment or otherwise limit the scope of the disclosure. Although one or more of these embodiments may be preferred, the embodiments disclosed should not be interpreted, or otherwise used, as limiting the scope of the disclosure, including the claims. In addition, one skilled in the art will understand that the following description has broad application, and the discussion of any embodiment is meant only to be exemplary of that embodiment, and not intended to intimate that the scope of the disclosure, including the claims, is limited to that embodiment.

[0025] Embodiments of the IEB described herein is safer than traditional posterior spinal fusion. The device can be deployed as a day surgery without requiring a full service hospital. IN certain instance, IEB deployment does not require entry into the chest cavity (unlike vertebral body tethering) and requires a less demanding surgical skill-set. Furthermore, the device does not fuse the spine and is reversible.

[0026] FIG. 1 illustrates the bracing of the convex side of a spinal curvature and the straightening of the curvature via growth modulation over time. FIG. 2 is a more detailed view of one embodiment of an internal elastic brace (IEB), illustrating an example of one embodiment of a rib attachment anchor (overhead and side view) and an assembly of the anchor with a tether component deployed in a therapeutic situation.

[0027] Anchor Portion or Component. An anchor is configured to attach to a subject's rib and to the intervening segment or tether forming an elastic brace. The anchors fix the ends of the intervening segment to the ribs in such a way so as to provide a compression force pulling the ribs towards each other or maintaining the initial distance between ribs. The anchor is configured to be positioned on the rib on the side distal to the position of the tether and the other rib involved in the deployment of the device. The anchor can be a curved plate that conforms to the curvature of the rib. In certain aspects the anchor can be configured to receive two or more screws for attachment to the rib. In other aspects, the anchor can have bone anchors on the face of the anchor to interact and stabilize its position on the rib. In other aspects, the anchor is held in place by the force applied by the tether. The anchor is configured to receive and attach to one end of the tether. In certain aspects, the anchor provide a hole or slot through which the end portion of a tether is positioned. After being positioned the end of the tether is knotted or capped or a button or stop deployed so that the tether does not pass back through anchor.

[0028] The anchor can be a rigid plate. The anchor can be in the shape of a curved rectangle or other planar shape with a thickness of 0.01 to 0.5 cm, a width sufficient to wrap or complement the convex curvature of the rib (e.g., at least, at most, or about 0.5, 1, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0 cm, including all values and ranges there between), and a length of at least, at most, or about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 cm, including all values and ranges there between. The anchor can be made of a variety of materials. In certain aspects, the anchor can be metal; metal alloy; carbon fiber; synthetic resins such as polysulphones, polyphenyl sulphones, epoxides, acrylic resins, polyolefins, polyoxymethylene, polyphenylene sulphide, polyetherketones, polyamides and polyesters, preferably reinforced with carbon, glass and/or other high-strength synthetic fibers.

[0029] Intervening Segment or Tether. The intervening segment or tether can be an elongated segment having a circular, oval, or rectangular cross section. The tether have a thickness or diameter of at least, at most, or about 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0 cm, including all values and ranges there between; a width of at least, at most, or about 0.5, 1, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0 cm, including all values and ranges there between; and a length (when deployed) of at least, at most, or about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30 cm, including all values and ranges there between. In certain aspects, the tether can be provided or made at a pre-deployment length that can be cut or adjusted by the personnel deploying the IEB device to an appropriate length for a particular subject. The tether can be from suitable elastic materials include, but are not limited to, reinforced tendon graft, polyvinylchloride, polyurethane, polyethylene, nylon, silicone, fluoropolymers, polypropylene, polyesters, FIBERWIRE®, mersilene tape, or the like. In other aspects, the tether can include braided filaments of ultrahigh molecular weight polyethylene (UHMWPE) or similar substance, braided with strands of polyester, collagen, or other suture materials, such as PET, PEEK, silk nylon, and absorbable polymers, among many others. In certain instance the material will have a Young's modulus of elasticity of between 6 and 11.