Surgery – Instruments – Orthopedic instrumentation
Reexamination Certificate
2002-05-15
2003-12-09
Robert, Eduardo C. (Department: 3732)
Surgery
Instruments
Orthopedic instrumentation
Reexamination Certificate
active
06660009
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to surgical tools and a method of use thereof, and more particularly, to arcuate surgical nails and a method of using said nails to fixate a fracture of the distal radius.
2. Description of the Related Art
The distal radius joint is an inherently unstable joint due to its osseous geometry. Due to this instability, fractures of the distal radius must often be fixed in position after reduction to insure proper healing. While the related art is replete with a variety of bone fixation devices none are specifically designed for the fixation of the distal radius with a minimum of tissue disturbance and a minimum of periosteal involvement.
For example, U.S. Pat. No. 3,763,855 to McAtee discloses a medical device for the fixation of the ulna, in particular fixing the enlarged end of the ulna, the olecranon, against the forces generated by the strong pull of the triceps muscle. The device itself is a long rod which is inserted into the medullary canal of the ulna. The '855 patent differs from the present invention in that it consists of only one long nearly straight nail, rather than a group of smaller arcuate nails.
U.S. Pat. No. 4,055,172 to Ender et al., U.S. Pat. No. 4,667,663 to Miyata and U.S. Pat. No. 6,231,576 to Frigg et al., disclose long intra-medullary nails for correctly resetting fractured long bones such as the femur, for their immediate reuse. These patents teach inserting long flexible nails into one end of a long bone, and then through the medullary canal and into the fracture area. The fracture is then reduced by rotating the nail. The nail also functions to fix the fracture. The inventions described above differ from the present invention in that the present invention uses several shorter nails that are not capable of traveling from one end of a long bone to the other. Each nail is uniquely arcuate to be positioned in a specific position in the distal radius with a minimum of tissue disturbance.
U.S. Pat. No. 6,074,392 to Durham discloses a method and device for use in bone fixation procedures. The invention consists of a curved guide and associated pin. The guide is used to locate the pin at the desired entry point on the bone and the pin is tapped or hammered into place. The pin is then used as a guide for a reamer which clears space for an inter-medullary rod. The '392 invention differs from the present invention in that the present invention uses multiple arcuate nails that cooperate to fix a fracture of the distal radius. The arcuate nails used in the '392 invention function only to guide a reamer.
U.S. Pat. No. 6,273,892 to Orbay et al. discloses a fracture fixation system. The system is used for the insertion of a fixation pin into the medullary canal of a fractured metacarpal, metatarsal, or phalangeal bone for stable bone fixation. The system has one or more pins and an instrument for implanting the pins. The '892 invention is distinguishable from the present invention because the present invention has a number of arcuate pins specifically designed to fix the distal radius. The nails of the present invention are also sharp, as opposed to the blunt pins of the '892 invention.
None of the above inventions and patents, taken either singly or in combination, is seen to describe the instant invention as claimed.
SUMMARY OF THE INVENTION
The present invention is a set of surgical nails, a nail handler for inserting the nails into the radius, and a method of using the aforementioned tools to reduce and internally fix a fracture of the distal radius. Typically there are four nails used in the procedure. Each nail is made of stainless steel, is circular in cross section, has a headless first end and a pointed second end, and is 150 mm in length. Depending on the size of the radius to be reduced, the nails are either 1.5 mm or 2 mm in thickness. The shank of each nail is arcuate adjacent the pointed end, with the amount of curvature varying from nail to nail.
The nail handler has a body and a compression nut. The body is cylindrical in shape with two opposing ends. A hole capable of receiving a nail is defined in one end of the body. The portion of the body surrounding the hole (nail receiving end) is cut into four flexible sections and is externally threaded. The balance of the external surface of the body is knurled to enhance grip. The compression nut is internally threaded so as to be rotatably attachable to the threaded nail receiving end of the body.
The aforementioned instruments are used in conjunction with a novel method of fixing fractures of the distal radius. The method involves first making an incision proximally along the radial styloid of the distal radius and dissecting the soft tissues therein. The fracture is approached between the compartment of the abductor pollicis longus and the extensor carpi radialis brevis. From there the fracture is approached from the radial, and if needed, the dorsal aspect of the radius.
The fracture itself is reduced using traction, counter traction and rotation, all performed under imaging intensified x-ray control. Once reduced, the fracture is ready for internally fixation. Four holes are drilled in the radial aspect of the radius. The holes are aligned so one of the nails may be positioned in each hole such that the nails travel through the medullary canal and into the subcortical area of the distal radius.
Accordingly, it is a principal object of the invention to provide a set of nails and a nail insertion tool capable of fixing a fracture of the distal radius.
It is another object of the invention to provide a surgical method of distal radius reduction and fixation which creates a minimum of disturbance to the associated tissues and bone.
It is a further object of the invention to provide a surgical method and fixation kit that obviates the risk of tendon ruptures and reactions and does not compromise the vascularity of the distal radius.
Still another object of the invention is to provide a fracture fixation system and method of using the system for fixation of a fracture of the distal radius that is easy to preform, teach and learn.
It is an object of the invention to provide improved elements and arrangements thereof in an apparatus for the purposes described which is dependable and fully effective in accomplishing its intended purposes.
REFERENCES:
patent: 3763855 (1973-10-01), McAtee
patent: 4011863 (1977-03-01), Zickel
patent: 4055172 (1977-10-01), Ender et al.
patent: 4135506 (1979-01-01), Ulrich
patent: 4667663 (1987-05-01), Miyata
patent: 4712541 (1987-12-01), Harder et al.
patent: 5013314 (1991-05-01), Firica et al.
patent: 5135527 (1992-08-01), Ender
patent: 5281225 (1994-01-01), Vicenzi
patent: 6019762 (2000-02-01), Cole
patent: 6074392 (2000-06-01), Durham
patent: 6231576 (2001-05-01), Frigg et al.
patent: 6273892 (2001-08-01), Orbay et al.
patent: 2003/0149433 (2003-08-01), Hehli et al.
Litman Richard C.
Robert Eduardo C.
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