The present invention generally relates to devices the align bones of the human upper extremities and guide insertion of pins, screws, and the like in these bones More specifically, the present invention relates to devices for aligning the Scaphoid and Lunate bones of a human wrist and a guide for inserting a percutaneous guide wire and placement of a screw to hold anatomical reduction of the scaphoid and lunate after disruption or damage of the scapholunate interosseous ligament has occurred.
Until recently orthopedic surgeons had inadequate tools to assist in wrist surgeries, particularly related to scapholunate instability and non-displaced scaphoid fractures. Prior to that, such repairs to the upper extremity required considerable skill on the part of the surgeon and an even greater amount of guess work and luck.
Currently, Acumed LLC of Hillsboro, Oreg., manufactures a Scaphoid Targeting Guide that greatly improves the state of the art. The Acumed device facilitates percutaneous guidewire placement for non-displaced fractures of the scaphoid. The guide device enables a screw to be accurately and precisely placed down the central axis of the scaphoid. Further, the Acumed device includes a clamping feature to hold the patient's hand firmly in position while moving from anterior-posterior views to lateral views for imaging. And, under fluoroscopy, the device assists the surgeon better align the guide relative to proper scaphoid positioning.
A similar device is described in U.S. Pat. No. 7,674,264 issued on Mar. 9, 2010 to Feiler et al. Therein, a surgical appliance for assisting in the repair of a fractured bone, such as a scaphoid bone, is disclosed. The device includes a first and second adjustably interconnected and spaced apart limb clamping jaws that are transparent to x-rays and are movable relative to each other along its vertical axis. A rotatable disk carried by the first jaw has a plurality of bores angularly disposed thereon. The bores enable selective alignment of a guide wire for percutaneous drilling into the fractured bone.
Feiler et al., in U.S. Pat. No. 6,695,841 issued on Feb. 24, 2004, described another percutaneous scaphoid fixation method and guide wire alignment device having two opposed clamping plates. In the '841 patent, Feiler et al. teach internal fixing a fractured bone by placing the limb in an x-ray-transparent stabilizing clamp. The clamp includes a pair of opposed relatively movable jaws between which the wrist is inserted. The jaws are closed over the dorsal and palmar sides of the wrist, which is held in position between the clamps for imaging and subsequent use to align a guide wire.
Yet another clamping device and method of use is described again by Felier et al. in U.S. Pat. No. 6,589,242 issued on Jul. 8, 2003. In this version a jig inserts between the opposing clamping plates. The jig consists of a solid block that is pivotally and slidably mounted on a rod that extends through the dorsal clamp. The block is locked into relative position and orientation by a thumbscrew and a plurality of holes on the block enable a guide wire to be aligned relative the hand that is clamped between the two jaws.
These known clamping devices and other such similar iterations of devices and associated methods for aligning bones of the wrist and inserting guide wires have some limitations. Such limitations include the inability to target two bones simultaneously, they do not lock onto the bones targeted, just the exterior of the wrist. Also these devices are not completely stable to the targeted bones when the wrist is moved.
Other teachings of the prior art include non-clamping guide devices. These devices are generally characterized by having an insertion-point guide end and an oppositely spaced targeting end. These two ends are typically coupled by a bridging like mechanism that is designed to clear the external anatomy of a patient. One such representative non-clamping guide device of the prior art includes an apparatus and procedure for blind alignment of fasteners extended through transverse holes in an orthopedic locking nail, as described by Perdue in U.S. Pat. No. 4,848,327 issued on Jul. 18, 1989. Therein Perdue discloses a jig requiring considerable surgical skill to set in precise reference or indexing position to facilitate forming holes through the skin and bone of a body location precisely coaxially aligned. The jig includes an elongated I-beam that suspends two oppositely spaced and downward extending, vertically mounted tracking guides.
Yet another aiming guide is described by Fernandez et al. in U.S. Pat. No. 7,887,545 issued on Feb. 15, 2011. Therein an elongated aiming arm supports an aiming portion with two coplanar transverse holes. Again, the aiming arm is adapted for external use to span over a portion of the patient's anatomy. Relative positioning is accomplished by coupling the aiming arm to an intermedullary nail before it is inserted in the bone. Then, as the nail penetrates the bone, the aiming arm moves correspondingly exterior to the body.
One problem of such external guides that do not use a pair of clamping jaws is that they are time-consuming to align precisely, require considerable skill by the user to make precise alignments and are easy to move out of position.
Thus, there remains a need for an alignment guide and method of use that overcomes these limitations. Such an improved device and method should target two bones simultaneously and fix relative and directly to anatomical structure instead of locating by the exterior of the hand or wrist as currently taught in the art. Further, there is a need for a device that externally clamps to a patient's hand quickly, yet allows the surgeon to move the hand freely without worrying that the position of a targeting guide relative to the clamp will become mis-aligned or dislodged. Further, such a device should include a targeting guide that allows for precise external alignment of a guide wire relative to either the left or right hand's scaphoid and lunate bones, and further allow adjustment to the alignment guide when clamped relative to the external hand of the patient. Another need is for a guide that also protects the patient's soft tissue.