Surgery – Instruments – Orthopedic instrumentation
Reexamination Certificate
2001-10-10
2004-06-15
Robert, Eduardo C. (Department: 3732)
Surgery
Instruments
Orthopedic instrumentation
Reexamination Certificate
active
06749614
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to medical devices and, more particularly, to systems for forming orthopedic fixation or stabilization implants in place within the body, such as by infusing a formable media into a cavity. In one application, the present invention relates to minimally invasive procedures and devices for forming a spinal stabilization rod in situ.
2. Description of the Related Art
The human vertebrae and associated connective elements are subject to a variety of diseases and conditions which cause pain and disability. Among these diseases and conditions are spondylosis, spondylolisthesis, vertebral instability, spinal stenosis and degenerated, herniated, or degenerated and herniated intervertebral discs. Additionally, the vertebrae and associated connective elements are subject to injuries, including fractures and torn ligaments and surgical manipulations, including laminectomies.
The pain and disability related to these diseases, conditions, injuries and manipulations often result from the displacement of all or part of a vertebra from the remainder of the vertebral column. A variety of methods have been developed to restore the displaced vertebrae or portions of displaced vertebrae to their normal position and to fix them within the vertebral column. For example, open reduction with screw fixation is one currently used method. The surgical procedure of attaching two or more parts of a bone with pins, screws, rods and plates requires an incision into the tissue surrounding the bone and the drilling of one or more holes through the bone parts to be joined. Due to the significant variation in bone size, configuration, and load requirements, a wide variety of bone fixation devices have been developed in the prior art. In general, the current standard of care relies upon a variety of metal wires, screws, rods, plates and clamps to stabilize the bone fragments during the healing or fusing process. These methods, however, are associated with a variety of disadvantages, such as morbidity, high costs, lengthy in-patient hospital stays and the pain associated with open procedures.
Therefore, devices and methods are needed for repositioning and fixing displaced vertebrae or portions of displaced vertebrae which cause less pain and potential complications. Preferably, the devices are implantable through a minimally invasive procedure.
SUMMARY OF THE INVENTION
There is provided in accordance with one aspect of the present invention, a method of treating the spine. The method comprises the steps of attaching a first support structure to the spine, and attaching a second support structure to the spine. A crossbar is attached to the first and second support structures, and at least the attaching a crossbar step comprises advancing at least a portion of the crossbar between the spine and a muscle layer.
In accordance with another aspect of the present invention, there is provided a method of treating a patient. The method comprises the steps of securing a first rod at a first site in the patient. A second rod is secured at a second site in the patient. Curable media is introduced in between the first and second rods to form a cross link. The first rod is linked to the second rod by permitting the media to cure.
The introducing step in one application of the invention comprises introducing the curable media into a tubular media support structure extending between the first and second rods. The support structure may comprise a balloon. Preferably, the method is accomplished percutaneously.
There is provided in accordance with a further aspect of the present invention, a subcutaneously assembled in place orthopedic construct. The construct comprises a first support structure, attached to the spine. A second support structure is also attached to the spine. A crossbar connects the first support structure to the second support structure to form an orthopedic construct. The crossbar is attached to the first and second support structures subcutaneously, without the need for an open surgical cutdown.
The first support structure preferably comprises a hardenable media, and the second support structure preferably also comprises a hardenable media. The crossbar may additionally comprise a hardenable media. A first cross tie may be provided, to connect the crossbar to the first support, and a second cross tie may be provided to connect the crossbar to the second support. Alternatively, the crossbar includes a first aperture for receiving the first support and a second aperture for receiving the second support.
At least the first support structure and, in some applications both the first and the second support structure comprises an outer wall, defining a cavity therein. A plurality of reinforcing fibers are positioned in the cavity, and a hardenable media for bonding with the reinforcing fibers is provided in the cavity to form the support structure. The hardenable media may be hardened while the support structure is positioned within the body of a patient, to create an orthopedic construct.
The hardenable media comprises an epoxy, a polyurethane, or other curable material. The reinforcing fibers may comprise carbon fibers, stainless steel or other reinforcing fibers.
In one application, the reinforcing fibers comprise graphite fibers having a diameter within the range of from about 0.003 inches to about 0.007 inches. The reinforcing fibers may be provided in at least one bundle, having within the range of from about 3,000 to about 12,000 fibers.
The reinforcing fibers may have a tow tensile strength within the range of from about 5,000 MPA to about 7,000 MPA. The reinforcing fibers may have a tow tensile modulus within the range of from about 250 GPA to about 350 GPA. Preferably, at least one reinforcing sleeve is provided within the cavity.
Further features and advantages of the present invention will become apparent to those of skill in the art in view of the detailed description of preferred embodiments which follows, when considered together with the attached claims and drawings.
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Nguyen Thanh Van
Pham To V.
Shaolian Samuel M.
Teitelbaum George P.
Knobbe Martens & Olson Bear LLP.
Robert Eduardo C.
Vertelink Corporation
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