Scoliosis brace

This invention relates to a three-dimensional scoliosis support system capable of providing pain relief and improvement of the spinal balance in scoliosis patients with different curve types. The disclosed bracing system is a tension-based scoliosis orthosis that comprises an rigid back panel. The three de-rotational supports pads of the back panel are connected to each other, providing facilitation or restriction of certain movements of human spine in the three different anatomical planes, i.e., coronal, sagittal and transverse planes. This scoliosis brace includes inelastic straps connected to the de-rotational supports/pads of the back panel, and the bracing system has different sizes and it can be fitted and adjusted accordingly with scoliosis curve type and patient characteristics.

CROSS REFERENCE TO RELATED APPLICATION

Application Ser. Nos. 62/873,845 (“the '845 application”) and 62/873,846 (“the '846 application”), each of which is titled “Scoliosis Brace,” and each of which is incorporated by reference herein in its entirety for all purposes.

BACKGROUND OF THE INVENTION

Field of the Invention

The invention relates to methods and apparatus of orthopedic correction, stabilization and support, and in a particular embodiment, to a Tension-based Scoliosis Orthosis, commonly known as a Scoliosis Brace, such as might be used to stabilize and correct a patient's spinal deformation. A preferred embodiment is directed to a tension-based scoliosis orthosis having a Y-shaped rigid back panel that generates continuous de-rotational forces in the transverse anatomical plane and translation forces in the coronal and sagittal planes. Proposed uses include orthopedic correction and stabilization of spinal deformations through a patient's daily, near-continuous, long-term wearing of the scoliosis brace.

Description of Related Art

Scoliosis is among the most common disorders of the spine, affecting approximately 3 in every 100 people worldwide [1]. Scoliosis presents itself as a misalignment of the spinal column, which is generally defined as a curve that deviates from the central spinal axis by greater than 10 degrees. While often simply characterized as a lateral curvature in the frontal plane, a rotational deformation about the transverse plane is common. For this reason, the various forms of scoliosis are more accurately described as complex three-dimensional deformities with misalignment occurring in the frontal and sagittal planes, as well as rotation in the transverse plane.

Scoliosis is a complex three-dimensional deformity of the spine, and there are two main types of adult scoliosis, the idiopathic and degenerative. According with Scoliosis Research Society (SRS) the adult idiopathic scoliosis is a prolongation of the adolescent idiopathic scoliosis (AIS), and the adult “De novo” degenerative scoliosis is a type of scoliosis that begins during the adult life due to arthritis and degeneration of the musculoskeletal system [2].

Adults with scoliosis can have more and a greater variety of symptoms compared with adolescents and younger patients. The adults have more symptoms because of the degeneration of the soft and hard tissues of the musculoskeletal system. The most common symptoms of adult scoliosis patients are back pain, stiffness, numbness, cramping and shooting pain in the legs, that can lead to gradual loss of function.

Aebi et al. classified adult scoliosis into three major types [3], all leading to an asymmetric breakdown of spinal discs and facet joints. Adults scoliosis can stem from one or more pathologies. The Type 1-3 classification scheme provided by Aebi, et al. [3] categorizes each based on the pathology that is thought to have led to the scoliosis. The Type 1 and Type 3 are the most clinically relevant groups. The Type 1 adult scoliosis is the degenerative scoliosis and is first seen late in life (“de novo”) often after age 65 due to normal wear and tear on an aging spine. It is usually located in the thoracolumbar or lumbar spine and is often thought to express the mildest symptoms of the three cases [2] [3].

The treatment options for adult scoliosis patients are the conservative (non-operative) treatment for patients that don't have disabling symptoms, and the operative treatment for patients that failed the non-operative therapies and for patients that have restricted functional activities and substantially have reduced overall quality of life [2].

Bracing is an important modality of the non-operative treatment of scoliosis, principally in treatment of Adolescent Idiopathic Scoliosis (AIS). The main goal of bracing therapy for AIS patients is to prevent the progression and/or correct the scoliosis curves during the bone growth period. A rigid thoraco-lumbo-sacral orthosis (TLSO) is a brace worn to minimize progression of AIS. There are various TLSO designs (e.g., Boston, Milwaukee, Wilmington) [4]. The Boston brace is one kind of the traditional rigid braces and is the most frequently prescribed scoliosis braces for adolescents with idiopathic scoliosis. One limitation about the Boston brace is that it weakens the muscles and stiffens the spine. There are studies that found the traditional TLSO does not correct the three-dimensional deformity even though it reduces the cobb angle [6].

One another brace that is used for the conservative treatment of AIS is the Rigo-Cheneau type brace. Historically, the Cheneau-type brace was designed to oppose the spinal torsion and correct scoliosis in three dimensions [7]. The Cheneau type brace was developed approximately twenty-five years ago, with the main goal to combine biomechanical forces in three different anatomical planes [5], including de-rotations of the scoliosis curve in the transverse plane. Typically, the Rigo-Cheneau type brace has an open pelvis design with anterior opening [5]. Lebel et al found that in-brace Apical Vertebral Rotation (AVR) of scoliosis curve was significantly reduced by the Cheneau brace when compared to the TLSO brace” [8].

The Rigo-Cheneau Brace has proven more effective in three-dimensional correction of spinal curvature in cases of idiopathic scoliosis when compared to other contemporary methods (and its technical principles will therefore be taken as a standard in our analysis). Each case of scoliosis has its own unique curvature profile and the brace design is different for each case. There are three biomechanical principles that are implemented in order to move the trunk into the best-balanced position. These principles are three-point system in the frontal plane, de-rotation in the transverse plane, and physiological alignment in the sagittal plane. The general technique is to achieve morphological 3D correction by using a combination of forces applied to the trunk surface through specifically designed pads, facilitated by expansion spaces. There is a corrective reaction of the body in response to these forces, resulting in more improved posture and spinal alignment [7].

Research shows that braces that provide three-dimensional corrective forces produce better outcomes to prevent the progression or correct scoliosis [5][7] [8].

For adult patients, the main objectives of the bracing therapy are to provide relief of the symptoms and to promote a more balanced posture to improve the quality of life during daily living activities [2]. The existing scoliosis braces for adult patients available in the market don't provide an effective three-dimensional treatment of the scoliosis. This invention relates a three-dimensional tension-based scoliosis orthosis capable providing short term pain relief when in use and improvement of the spinal balance in scoliosis patients with different curve types. The disclosed bracing system is adjustable and personalized to provide the efficient three-dimensional correction to the specific curvature pattern of the patient.

SUMMARY OF THE INVENTION

The invention is directed to systems, methods, and apparatus involving scoliosis bracing using a three-dimensional support system capable of providing pain relief and improvement of the spinal balance in scoliosis patients with different curve types. The disclosed bracing system is a tension-based scoliosis orthosis that contains a rigid back panel. The rigid back panel generates continuous de-rotational forces in the transverse anatomical plane and translation forces in the coronal and sagittal planes. The de-rotational thoracic, lumbar and pelvic de-rotational supports/pads of the disclosed bracing system, provide facilitation or restriction of certain movements of human spine in the coronal, sagittal and transverse planes. The scoliosis bracing system may be used in cases of, for instance, idiopathic scoliosis and degenerative scoliosis. Moreover, the invention is also effective in treating postural abnormalities and unbalances of the spine wherein the ability to maintain more balanced and improved posture of the trunk, pelvis and shoulder girdle.

This tension-based scoliosis system is adjustable and personalized to provide an efficient three-dimensional support to the specific curvature pattern of the patient. The adjustability of supportive/compression/pressure and tension forces are achieved by incorporating the design of the rigid back panel, attaching pads and strapping system. This bracing system generates a three point of pressure that is able to apply appropriate forces in the transversal plane, coronal plane and sagittal plane wherever it is needed for a given case as determined by the physician. With the appropriate determination of the direction and magnitude of the pressure from the bracing system, the rotational aspect of the scoliosis can also be corrected. The hole system performs the sufficient pressure to support and stabilize an imbalanced trunk, and also restrict or facilitate the ability of patients to move. The mechanical properties of the back panel and strap system have a high strength to provide the appropriate support/compression and sufficient tension.

This tension-based scoliosis system provides also proprioceptive feedback of the trunk muscles, which helps to develop muscular memory so that the body can actively correct posture when the system is not in use.

The disclosed tension-based scoliosis system is lightweight and portable for frequent or daily use, while easily custom fitted. The design this bracing system is simple, allowing the patients to easily wear and take off the brace every day without assistance.

The materials of this support system are biocompatible and hypoallergenic due to the possibility of direct contact with user's skin. To ensure proper hygiene the brace can be washable. The long-time wearing of the brace should not stiffen the muscle and cause inflammation of the skin. The brace design has also a function to reduce the side effects of insufficient blood supply and limited breath, which exist in current products. In order to mitigate pressure points the brace design doesn't have any sharp edges or corners.

Further aspects of the invention are set forth herein. The details of exemplary embodiment of the invention are set forth in the accompanying drawings and description below. Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims.

LISTING OF DRAWING REFERENCES AND NUMERALS

Group 1—Back Panel10—Y-shaped rigid/semi-rigid back panel11—V1 De-rotational pad of the back panel12—Y De-rotational pad of the back panel13—V2 De-rotational pad of the back panel14—“D” hole of the V1 De-rotational pad15—“D” hole of the V1 De-rotational pad16—Hole for the attachment of the lumbar belt—The lumbar belt will attach to the back panel through this hole.17—The adjustable Velcro hook and loop system/fastener on the inner face of the back piece that will attach with the lumbar belt.

Group 2—Lumbar Belt20—Semi-rigid lumbar belt21—V arm of the lumbar belt22—Y arm of the lumbar belt23—Velcro Hook of the V arm of the lumbar belt24—Cord system Y side of the lumbar belt25—Cord system of the V side of the lumbar belt26—Pull tab cord system of the V side of the lumbar belt that contains a Velcro hook that will attach to the Velcro loop fabric of the outer side of the belt.27—Pull tab cord system of the Y side of the lumbar belt that contains a Velcro hook that will attach to the Velcro loop fabric of the outer side of the belt.28—Cover of the cord system of the lumbar belt.29—The outer side of the arms of the lumbar belt are made with a Velcro hook fabric.210—The fabric permanently sewn in the lumbar belt that is going to attach to the back panel and attach to the cover of the back panel through

Group 3—Straps of De-Rotational Pads31—V1 Strap of the de-rotation pad32—V2 Strap of the de-rotational pad33—Removable Velcro hook V1 strap34—Removable Velcro hook V2 strap35—Velcro hook permanently sewn on the distal end of V1 strap36—Velcro hook permanently sewn on the distal end of V2 strap37—Proximal end of the strap without the removable hook38—Nylon fabric sewn in the distal edge of the strapGroup 4—Cover of back panel40—Cover of the rigid/semi rigid back panel made of foam and polyester mesh41—Elastic fabric to attach the cover made of foam and polyester mesh to the V1 de-rotational pad of the back panel.42—Elastic fabric to attach the cover made of foam and polyester mesh to the V2 de-rotational pad of the back panel.43—Elastic fabric to attach the cover made of foam and polyester mesh to the Y de-rotational pad of the back panel.44—The posterior section of the back-panel cover is made from polyester fabric with Velcro loop and is in contact with inner face of the back panel.

DETAILED DESCRIPTION

As shown inFIG. 1andFIG. 2, an exemplary of the tension-based scoliosis orthosis according to the invention may include, for example: a rigid/semi-rigid back panel10; a lumbar belt20connected to the rigid back panel; a cover40of the rigid/semi-rigid back panel; and the V1 strap31and V2 strap32connected to the rigid/semi-rigid back panel. The V1 strap31and the V2 strap32and any other disclosed strap may be made, for instance, of durable nylon, polyester, rayon, cotton, leather, pliable resin, pliable rubber, woven fabric, etc.

FIGS. 1 and 2show the V arm21and the Y arm22of the lumbar belt20.FIG. 1shows the sewn Velcro hook23in the V arm21of the lumbar belt. The fabric on the outer side of the lumbar belt is made from a fabric with Velcro loop, shown inFIG. 2.

FIG. 3Ashows the rigid/semi-rigid back panel10. The back panel in one side has two de-rotational pads, the V1 de-rotational pad11and the V2 de-rotational pad13and in the other side has one de-rotational pad, the Y de-rotational pad12. The back panel has a “D” hole14in the V1 de-rotational pad11and a “D” hole15in the V2 de-rotational pad. The V1 strap31and V2 strap32are going to attach to the de-rotational pads of the back panel through the “D” holes14and15respectively.FIG. 3Ais shown the hole16that was developed to create the adjustable Velcro hook and loop system/fastener.

FIGS. 3B and 3Cshow the adjustable Velcro hook and loop system/fastener17on the inner face of the rigid/semi-rigid back panel that will attach to the small durable nylon/polyester strap210permanently sewn in the lumbar belt20. The rigid/semi-rigid back panel10and de-rotational straps31and32of this invention are the cores of the improved tension-based scoliosis orthosis and these components10,31and32can be attached and adapted to other types of lumbar belts through the adjustable Velcro hook and loop system/fastener.FIGS. 3B and 3Cshow the side211of the strap210that is going to attach to the Velcro hook that is in the inner face of the back panel17.FIG. 2shows posterior section44of the cover40of the back panel. The posterior section44of the back-panel cover made from polyester fabric with Velcro loop and is in contact with inner face of the back panel.FIGS. 3B and 3Cshows the Velcro hook212of the strap210of the lumbar belt20that is going to attach to the Velcro loop44of the cover of the back panel.

FIGS. 4A and 4Bshows the detailed view of V1 strap31and V2 strap32that are going to attach to the de-rotational pads of the back panel,11and13respectively and to the outer section of the V arm21of the lumbar belt20. For custom fit and for an optimal adjustment of the tension of the straps V131and V232, a health care professional can remove the Velcro hook piece33and/or34that is in the proximal end37of the strap shown inFIGS. 4C and 4D. The professional health care can customize/trim the size of the strap accordingly with the patient size, patient characteristics, scoliosis curve pattern and degree of deformity. After customization of the straps, the professional health care can setup, attach and adjust the straps in the de-rotational pads of the rigid/semi-rigid back panel10and lumbar belt20.FIGS. 1 and 2show the V1 strap31and V2 strap32attached to the rigid/semi-rigid back panel through the “D” holes14and15. The removable Velcro hook33and34along the proximal end of the straps allows easy adjustment about the length. The Velcro hook pieces35and36permanently sewn on the distal end of V1 strap31and on the distal end of V2 strap32are going to be fixed in the Velcro loop of the outer side of V arm21of the lumbar belt20, shown inFIG. 2.

To understand better the application of the disclosed invention is described an application of this improved tension-based scoliosis system to a body of a wearer with a left lumbar/thoracolumbar scoliosis.FIG. 5Ashows a typical posterior view of an x-ray of a person with a left lumbar/thoracolumbar scoliosis and its relationship with the different structural blocks of the spine, pelvis, lumbar/thoracolumbar and thoracic.FIG. 5Billustrates de direction of the rotation of the structural blocks of the spine of a person with a left lumbar/thoracolumbar scoliosis. For this specific scoliosis curve pattern of a left lumbar/thoracolumbar curve, when viewing the transverse plane from the top the lumbar/thoracolumbar block is rotated in the anti-clockwise direction and the thoracic and pelvis blocks are rotated in the clockwise direction.FIG. 6Ashows typical posterior view of a deformed body of a person with a left lumbar/thoracolumbar scoliosis and its relationship with the convexity and concavity of the scoliosis curve.FIG. 6Bshows an illustration of a slice of the transverse plane of the body of the patient at the apex of a left lumbar/thoracolumbar curve.FIG. 6Cillustrates the appropriate application of the supportive forces of the bracing system in a body of a person with a left lumbar/thoracolumbar scoliosis. The thoracic, lumbar and pelvis pads are going to de-rotate the structural blocks of the spine in the opposite direction of the scoliosis deformity.

FIGS. 7A-7Billustrates the de-rotational forces that the disclosed tension-based scoliosis tension system is going to apply in a body of a wearer with a left lumbar/thoracolumbar scoliosis. The de-rotational forces are going to de-rotate the spine in the transverse plane and subsequent align the spinal segments in the frontal, transverse and sagittal planes.

Each de-rotational force has two components, the component of the coronal plane and the component of the sagittal plane. The V1 de-rotational pad11is going to apply the force Fv1in the thoracic block, the Y de-rotational pad12is going to apply the force FY in the lumbar/thoracolumbar block and the V2 de-rotational pad13is going to apply the force FV2in the Pelvis block.

FIGS. 8A-8Bshows the components of the de-rotational forces that are going to form the three-point pressure system in the coronal plane. In traditional scoliosis bracing a three-point force system is formed by a corrective force and two counterforces applied proximally and distally as shown inFIG. 8B. The Y de-rotational pad12is going to apply a corrective/supportive force FYC at the apex of the convexity of the scoliosis curve. The V1 de-rotational pad11going to apply a counterforce Fv1C in the proximal end of the concave side of the of the scoliosis curve. The V2 de-rotational pad13is going to apply a counterforce Fv2C in the distal end of the concave side of the of the scoliosis curve.

FIGS. 9A-9Bshows the components of the de-rotational forces in the sagittal plane. The force FV1S of the V1 de-rotation pad11is going to de-rotate the thoracic block in the anti-clockwise direction. The force FYS of the Y de-rotation pad12is going to de-rotate the lumbar block in the clockwise direction. The force FV2S of the V2 de-rotation pad13is going to de-rotate the pelvis block in the anti-clockwise direction.

FIGS. 10A-10Cshow illustrations how to adjust the direction and magnitude of the de-rotational forces by using additional pads.FIG. 10Cshows the additional pad50that can be added and placed in the inner face of the rigid/semi-rigid back panel10and under the cover40. The pad50may be placed more laterally or more posteriorly depending of the magnitude of the rotation or translation that the patient needs to achieve a more balanced position of the spine and improved posture.

FIGS. 11A-11Cshows posterior and anterior view of the setup of the disclosed tension-based scoliosis system for a person with a left lumbar/thoracolumbar scoliosis. The geometric configuration and orientation of both straps31and32is highly adjustable. The bracing system is restricting the movement of side bending of the spine to the right side and facilitating the movement of side bending to the left. The tension-based scoliosis system is restricting the rotation of the thoracic block and pelvic block in the clockwise direction and facilitating the movement of rotation in the anti-clockwise direction. The tension-based scoliosis system is restricting the rotation of the lumbar/thoracolumbar block in the anti-clockwise direction and facilitating the movement of rotation in the clockwise direction.

FIG. 12shows the steps of a wearer putting the brace on. On step1the wearer holds the distal end of the V arm21and the distal end of the Y arm22of the lumbar belt20wrapping around the rigid/semi-rigid back panel10to provide consistent and strong support to the back, keeping the rigid/semi-rigid back panel10flush to the body of the wearer. There's a pulling system on the outer surface of the belt20. The two pulling tabs26and27of are two major components of the pulling system, which are used to adjust the tightness of the belt. The belt20gets tighter as the tabs are being pulled. The pelvic belt20applies compression to torso at lumbar level to achieve lumbar alignment with the use of the sagittal profile of back panel10. The compressive belt20transmits force to an Y de-rotational pad13of the rigid/semi-rigid back panel10, de-rotating the lumbar block in the transverse plane in the clock-wise direction and creating a lateral force FYC in the coronal plane toward the medial axis, shown inFIGS. 8A-8B.

FIG. 13shows the adjustment of the tension of the V1 strap31of the V1 de-rotational pad11. Tightness of the V1 strap31can be adjusted by attaching the Velcro hook35on the different Velcro loop sections of the V arm21of the pelvic belt that are on the same level but different distance relative to the front center line. The V1 strap31that is attached to the V1 de-rotational pad11of the rigid/semi-rigid back panel10, which impart force onto the right thoracic section of the body is de-rotating the thoracic block in the transverse plane in the anti-clockwise direction and creating a lateral force FV1C in the coronal plane toward the medial axis, as shown inFIGS. 8A-8B. As shown inFIGS. 10A-10Ca pad may be placed in the inner face of the V1 de-rotational pad11to adjust the direction and/or increase the magnitude of the de-rotational force FV1.

FIG. 14shows the adjustment of the tension of the V2 strap32of the V2 de-rotational pad13. Tightness of the V2 strap32can be adjusted by attaching the Velcro hook36on the different Velcro loop sections of the V arm21of the pelvic belt that are on the same level but different distance relative to the front center line. The V2 strap32that is attached to the V2 de-rotational pad13of the rigid/semi-rigid back panel10, which impart force onto the right pelvis section of the body is de-rotating the pelvis block in the transverse plane in the anti-clockwise direction and creating a lateral force FV2C in the coronal plane toward the medial axis, as shown inFIGS. 8A-8B. As shown inFIGS. 10A-10Ca pad may be placed in the inner face of the V2 de-rotational pad13to adjust the direction and/or increase the magnitude of the de-rotational force FV2.

FIGS. 15A-15Dshow the setup of the disclosed tension-based scoliosis system for a person with a right lumbar/thoracolumbar scoliosis.FIGS. 16A-16Dshow the Setup of the tension-based scoliosis system for a person with a Right Thoracic scoliosis curve.FIGS. 17A-17Dshow the Setup of the tension-based scoliosis system for a person with a Left Thoracic scoliosis curve.

FIGS. 18A-18Bshow the adjustment of the lumbar belt20on the back panel10for a person with a Lumbar/Thoracolumbar scoliosis curve. The adjustment of the lumbar belt on the panel is made through the adjustable Velcro hook and loop system/fastener of the inner face of the back panel, as shown inFIGS. 3B and 3C. Typically for these curve types the apex of the convexity of the scoliosis curve is located at the level of the lumbar/thoracolumbar block. The belt has to fixed in the center of the hole16of the back panel, so the Y de-rotational pad12will match with the apex of the scoliosis curve.

FIGS. 19A-19Bshow the adjustment of the lumbar belt20on of back panel10for a person with a long thoracic scoliosis curve. The adjustment of the lumbar belt on the panel is made through the adjustable Velcro hook and loop system/fastener of the inner face of the back panel, as shown inFIGS. 3B and 3C. Typically for these curve types the apex of the convexity of the scoliosis curve is located at the level of the thoracic block and we have to adjust the three-point pressure of the bracing system in higher level of the spine. The belt has to fixed in the lower section of the hole16of the back panel, so the Y de-rotational pad12will match with the apex of the scoliosis curve.

The foregoing description discloses exemplary embodiments of the invention. While the invention herein disclosed has been described by means of specific embodiments and applications thereof, numerous modifications and variations could be made thereto by those skilled in the art without departing from the scope of the invention set forth in the claims. Modifications of the above disclosed apparatus and methods that fall within the scope of the claimed invention will be readily apparent to those of ordinary skill in the art. Accordingly, other embodiments may fall within the spirit and scope of the claimed invention, as defined by the claims that follow hereafter.

In the description above, numerous specific details are set forth in order to provide a more thorough understanding of embodiments of the invention. It will be apparent, however, to an artisan of ordinary skill that the invention may be practiced without incorporating all aspects of the specific details described herein. Not all possible embodiments of the invention are set forth verbatim herein. A multitude of combinations of aspects of the invention may be formed to create varying embodiments that fall within the scope of the claims hereafter. In addition, specific details well known to those of ordinary skill in the art have not been described in detail so as not to obscure the invention. Readers should note that although examples of the invention are set forth herein, the claims, and the full scope of any equivalents, are what define the metes and bounds of the invention protection.

REFERENCES