US-20260123940-A1 - ORTHOPEDIC BONE AWL WITH OPTOELECTRONIC FEEDBACK

US20260123940A1US 20260123940 A1US20260123940 A1US 20260123940A1US-20260123940-A1

Abstract

A tool having a tip for creating a bore in bone for the insertion of a pedicle screw or the like, which transmits the color of the tissue adjacent the tip of the tool, and a method of using the tool.

Inventors

Stephen Banco
Richard Briganti
Lawrence Husick
Jeffrey O'Donnell

Assignees

WAYPOINT ORTHOPEDICS, INC.

Dates

Publication Date: 20260507
Application Date: 20221004

Claims (10)

1 . A surgical tool system for forming openings in a patient's bone, the bone having nerve tissue in the region of the openings to be formed, comprising: a tool handle shaped to be held and manipulated by a user when forming openings in the patient's bone; a power source, illumination source, color sensor, microcontroller, and radio frequency transceiver, located inside the tool handle; a shaft extending from a proximal end joined to the tool handle, to a distal end adapted to form openings in bone, the shaft containing an illuminating optical fiber having a proximal end optically coupled to the illumination source, and a sensing optical fiber having a proximal end optically coupled to the color sensor, each of the fibers having a distal end embedded at the distal end of the shaft; and a display having a radio frequency transceiver for communicating with the radio frequency transceiver in the tool, the display showing the color of the tissue located adjacent the distal end of the shaft.
2 . The surgical tool of claim 1 wherein the illumination source is a white light LED.
3 . The surgical tool of claim 1 wherein the shaft is canulated.
4 . The surgical tool of claim 1 wherein the shaft is further provided with a force sensor that is electrically coupled to the microcontroller.
5 . A surgical system comprising a general purpose digital computer having a visual display and radio frequency communication capabilities, the computer running special purpose software stored in the memory of the computer, the software adapted to process and display data received via radio frequency transmission from a surgical tool having color sensing capability; a surgical tool comprising handle containing a power source, illumination source, color sensor, microcontroller, and a radio frequency transceiver; a shaft extending from a proximal end joined to the tool handle, to a distal end adapted to form openings in bone, the shaft containing an illuminating optical fiber having a proximal end optically coupled to the illumination source, and a sensing optical fiber having a proximal end optically coupled to the color sensor, each of the fibers having a distal end embedded at the distal end of the shaft.
6 . A packaged sterile surgical kit comprising a tray, the tool of claim 1 , and a sealing lid.
7 . The tool of claim 1 wherein a unique serial number is displayed visually on the exterior of the tool, and is encoded electronically in the microcontroller's memory, and wherein the encoded serial number is transmitted via radio frequency to the display.
8 . A method of forming an opening in bone for the insertion of a surgical appliance comprising the steps of a) removing an insulating member to establish connection between a power source and a microcontroller circuit; b) initiating a software program running on a general purpose digital computer, the software program adapted to process and display data received from a surgical tool having color sensing capability; the surgical tool comprising handle containing a power source, illumination source, color sensor, microcontroller, and a radio frequency transceiver; a shaft extending from a proximal end joined to the tool handle, to a distal end adapted to form openings in bone, the shaft containing an illuminating optical fiber having a proximal end optically coupled to the illumination source, and a sensing optical fiber having a proximal end optically coupled to the color sensor, each of the fibers having a distal end embedded at the distal end of the shaft; c) impinging the surgical tool on the bone to be opened using sufficient force to create an opening in the bone; d) observing the color displayed on the computer display and in response to the displayed color, changing the force applied to the tool, the position of the tool, or the angle of the tool.
9 . The method of claim 8 wherein the impinging step c is facilitated by positioning and moving the tool using a surgical robot.
10 . The method of claim 8 wherein the observing and force changing step d is performed using an autonomous artificially intelligent controller and actuator.

Description

BACKGROUND OF THE INVENTION 1. Field of Invention The present invention relates generally to apparatus for inserting pedicle screws into the spine, and particularly to several embodiments of device whereby the likelihood of nerve damage caused by improperly placed pedicle screws can be reduced. 2. Discussion of the Prior Art Instances arise when it becomes necessary to stabilize or fuse a portion of the spine from motion such as, for example, (1) after decompression wherein certain posterior spinal elements are removed to relieve pressure on neural elements, (2) after trauma, or (3) because of the presence of tumors. Instruments that accomplish spinal fixation are known in the form of pedicle screws which are adapted to be inserted in selected vertebrae, and stiff rods, plates, tethers and other devices that connect adjacent pedicle screw heads to one another after the screws are inserted, thus resulting in the fixing or bracing of all vertebrae spanned by the stabilizing apparatus. The pedicles are the strongest parts of the spinal vertebrae and thus provide a secure foundation for the screws to which fixing rods or plates are attached. See R. Roy-Camille, et al, Internal Fixation of the Lumbar Spine with Pedicle Screw Plating, Clinical Orthopedics (February 1986), at page 7; and H. N. Herkowitz, et al, Instrumentation of the Lumbar Spine for Degenerative Disorders, Operative Techniques in Orthopaedics (January 1991), at page 91. To achieve the greatest mechanical integrity when anchoring pedicle screws in a spine, it is therefore essential that the screws be guided and threaded in alignment with the pedicle axis and not be allowed to deviate off axis in which case the screw body or its threads will either break through the vertebral cortex and impinge on or become dangerously close to surrounding nerve roots, or merely be inserted into softer bone regions having less structural strength. A jig adapted for providing locations on the pedicles of a vertebra for insertion of pedicle screws is disclosed in U.S. Pat. No. 4,907,577 (Mar. 13, 1990) which discloses that the vertebral bodies will be fixed more stably the deeper the screws are inserted in the pedicle, and that slight deviations in the angle of screw insertion can injure nerve roots or the spinal cord. Much appears in the literature with respect to the problems of misalignment of pedicle screws and the symptoms arising when the screws make contact with neural elements after breaking outside the pedicle cortex. Cutting into a nerve root or simply contacting the root gives rise to various postoperative symptoms such as dropped foot, neurological lesions, sensory deficits, or pain. The Adult Spine—Principles and Practice, Vol. II, at pages 1937 and 2035-36 (Raven Press 1991); J. L. West, et al, Complications of the Variable Screw Plate Pedicle Screw Fixation, Spine (May 1991), at 576-79; and J. L. West, et al, Results of Spinal Arthrodesis with Pedicle Screw-Plate Fixation, Journal of Bone and Joint Surgery (Sep. 1991), at 1182-83. The prior art teaches the use of electrical stimulation as a means of estimating how near the tip of a bone awl is approaching a nerve root or the spinal cord. U.S. Pat. No. 5,474,558 is one such disclosure. The prior art also teaches the use of force sensors to estimate the position of the tip of a bone awl. Conventional practice calls for the use of recognized landmarks along the spinal column for purposes of locating pedicle entry points, and the use of X-ray exposures or fluoroscopy to monitor the advancement of a metallic pedicle screw through the vertebra. But prolonged radiation exposure of the patient for purposes of proper screw placement is of course undesirable and this technique still has a significant misplacement rate. Further, prolonged and repeated exposure to ionizing radiation on the part of the surgeon and other medical personnel is undesirable and should be minimized whenever possible. The prior art also teaches the use of a probe inserted by a surgeon into a bore in the vertebral body to “feel” the depth of penetration and path of the bore. The use of a probe, however, requires that the bore be partially formed, the tool used to form the bore withdrawn, the probe inserted and manipulated, then withdrawn, and the tool reinserted to either deepen the bore or to correct the trajectory of the bore prior to deepening. This repetitive process lengthens the time required to properly insert each pedicle screw, and thus, lengthens the entire procedure, potentially elevating the risk to the patient due to additional time under anesthesia, and time in on the operating table, in general. It is known generally that various tissues of the body appear differently colored when observed under ambient light, as, for example, during open surgery or during autopsy. In particular, neural tissues such as the spinal cord and nerves emanating from the cord at the nerve roots are perceived under white light as translucent white.