Body brace with adjustable hinge mechanism

Surgery: splint – brace – or bandage – Orthopedic bandage – Splint or brace

Reexamination Certificate

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Details

C602S019000

Reexamination Certificate

active

06676617

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates generally to body braces, and, more particularly, relates to an adjustable, interlocking iliac crest belt assembly for use in such body braces.
BACKGROUND OF THE INVENTION
Body braces of the type designed to immobilize a patient's spine following lumbar or other spine surgery, or to treat scoliosis and other abnormal curvatures of the spine, such as hyperlordosis and hyperkyphosis, are known in the art.
By way of example, U.S. Pat. No. 5,503,621 to Miller, assigned to Boston Brace International, Inc., discloses a body brace for use in the treatment of scoliosis and other spinal abnormalities. The brace includes a bottom shell sized and shaped to be fitted around a patient's pelvis, a middle shell sized and shaped to be fitted around the patient's abdomen, and a top shell sized and shaped to be fitted around the back and the sides of the patient's rib cage. The top shell is made up of a left segment and a right segment. The middle shell is connected to the bottom shell by first and second lockable swivel mechanisms which provide for lateral, front and back, and rotational movement of the middle shell relative to the bottom shell. The left segment of the top shell is connected to the middle shell by a third lockable swivel mechanism which provides for lateral, front and back, and rotational movement of the left segment of the top shell relative to the middle shell, independent of the right segment of the top shell. The right segment of the top shell is connected to the middle section by a fourth lockable swivel mechanism which provides for lateral, front and back, and rotational movement of the right segment of the top shell relative to the middle shell independent of the left segment of the top shell. Releasable fasteners are attached to the top, middle and bottom shells to assist in holding the brace in place on the patient's pelvis, abdomen and rib cage, respectively.
Similarly, U.S. Pat. No. 5,474,523 to Miller, assigned to Boston Brace International, Inc., discloses a relatively rigid body brace for treating scoliosis in a patient while preventing hypokyphosis (flattening) in the patient's thoracic spine. The brace includes a shell shaped to surround the torso of a person in such a way as to correct scoliosis. The shell has an outer layer of hard plastic material and an inner layer of compressible plastic material bonded to the outer layer. The shell is preferably made from a single section and has a vertically extending split portion. To prevent hypokyphosis, the shell is shaped to define a kyphotic angle in the thoracic spine of approximately 20 to 25 degrees. The shell may additionally be shaped to define a lordotic angle in the lumbar spine of approximately 15 degrees to make the brace more comfortable to the wearer.
U.S. Pat. No. 3,871,367 to Miller, assigned to Boston Brace International, Inc., discloses a pelvic girdle comprising an outer layer of a substantially rigid plastic material and an inner layer of soft compressible plastic material bonded to the outer layer, the girdle being shaped to engage a person's pelvis and including an anterior and a vertically split posterior portion, the girdle having an upper anterior portion separated laterally from the remainder of the girdle and curving outwardly thereof, and connecting upper side portions on the girdle connecting the anterior and posterior portions thereof and including inwardly curved sections in both layers of the girdle for engaging the iliac crests of the wearer and which sections have appreciably thicker compressible inner layers thereon.
U.S. Pat. No. 4,202,327 to Glancy discloses a dynamic orthosis device which utilizes elastic forces to treat a patient who has scoliosis or other curvatures of the spine. The disclosed orthosis device includes first and second shell segments provided with a connecting arrangement for adjustably aligning the segments so as to encompass the torso of the patient. At least one pressure pad is pivotally mounted to one of the shell segments, and an elastic strap is adjustably secured to one of the shell segments so as to exert a predetermined force on the pressure pad. The elastic strap, pressure pad and shell segments cooperate to apply adjustable dynamic forces to correct abnormal curvatures of the patient's spine.
U.S. Pat. No. 5,012,798 to Graf et al discloses a dynamic orthosis device for the tridimensional reduction of scoliosis. The dynamic orthosis device includes two elastically deformable plastic hands joined at the anterior of the device to laterally enclose the thorax of the patient. The hands assembly is connected to a pelvic girdle by at least two lateral supports made of elastically deformable semi-rigid material. As the rear of the hands, which are not attached, are expanded outward due to the movement of the thorax of the patient, the lateral supports provide a torsional return stress which forces the hands to create a pressure on the body of the patient. This pressure is beneficial in reeducating the spine of the patient and thereby reduces scoliosis.
U.S. Pat. No 5,158,531 to Zamosky discloses a spinal orthosis which includes a continuous interior framework of ⅛″ low density polyethylene sandwiched between layers of ¼″ thick aliplast. The spinal orthosis also includes an anterior opening to provide cosmetic acceptability and independence of the user for placing on and removing the orthosis. A floating abdominal apron is provided to cover the anterior opening and the orthosis is devoid of joints and hinges to accomplish flexion and extension.
In a related area of development, support belts intended to maintain a preferred spinal orientation are also known in the art. Among these, U.S. Pat. No. 5,984,886 to Miller, assigned to Boston Brace International, discloses a support belt to be worn around the waist of a person. The support belt includes an elongated multi-layer strip having a center portion and a pair of ends. The elongated multi-layer strip is sized and shaped so as to encircle the waist of the person, with the center portion positioned against the back of the person and the pair of ends positioned against the front of the person, the pair of ends being releasably fastenable together to secure the support belt around the waist of the person. The center portion of the elongated multi-layer strip is shaped to define an angle of lordosis of approximately 15 degrees in the lumbar spinal region. A pair of inwardly curved sections, sized and shaped so as to urge against the iliac crests of the person wearing the support belt, are mounted on the multi-layer strip. The multi-layer strip may comprise a layer of rigid plastic and a pair of layers of a soft compressible plastic.
Other patents of interest include U.S. Pat. Nos. 5,111,807; 5,074,288; 5,072,725; 5,039,247; 5,000,169; 4,957,103; and 3,171,407.
The disclosure of each patent cited herein is incorporated herein by reference.
While the above-listed patents to Boston Brace International, Inc. and other manufacturers disclose useful bracing and support configurations, in many clinical situations, there is a need for additional sources of stabilization force and pressure to maintain proper spinal orientation. Thus, there is a need for additional stabilization and support elements for body braces that can provide such additional stabilization.
Accordingly, it is an object of the invention to provide improved stabilization elements for a body brace for post-surgical spinal stabilization and treatment of abnormal curvatures of the spine.
It is another object of the present invention to provide such stabilization elements for a body brace that can be used in the treatment of lateral, forward, backward, and rotational curvatures of both the upper and lower spine.
It is a further object of the invention to provide such stabilization elements having adjustable, lockable pressure elements.
It is yet another object of the invention to provide such a brace that is relatively simple to manufacture,

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