System and Methods of Using Image-Guidance for Providing an Access to a Cochlear of a Living Subject

Abstract

A system and methods for providing an access to a cochlea of a living subject. In one embodiment of the present invention, a method comprises the steps of operating a surgical instrument towards a region of interest of the living subject for opening an access to the cochlea of the living subject from the lateral edge of the skull of the living subject to the cochlea of the living subject, and intra-operatively monitoring at least a part of the surgical instrument so that the surgical instrument is operated substantially along a predetermined path.

What is claimed is: 
     
         1 .- 15 . (canceled) 
     
     
         16 . A system for providing an access o a cochlea of a living subject, comprising:
 a. means for non-invasively placing a plurality of fiducial markers surrounding the cochlea of the living subject;   b. an imaging acquisition device for pre-operatively acquiring an image volume from the cochlea of the living subject, the pre-operatively acquired image volume containing the image of the plurality of fiducial markers;   c. a surgical instrument having a distal end portion for opening an access to the cochlea of the living subject;   d. an infrared tracking system for pre-operatively measuring a location of each fiducial marker and intra-operatively monitoring a location of the distal end portion of the surgical instrument in the anatomic space of the cochlea of the living subject;   e. a controller for receiving and processing data related to the pre-operatively acquired image volume, the pre-operatively measured location of each fiducial marker and the intra operatively monitored location of the distal end portion of the surgical instrument so as to guide the surgical instrument along a predetermined path to open an access to the cochlea of the living subject; and   f. an image display device in communication with the controller for displaying the location of the distal end portion of the surgical instrument.   
     
     
         17 . The system of  claim 16 , wherein the placing means comprises:
 a. a locking dental acrylic resin splint (LADS) mountable to a maxilla of the living subject, wherein the LADS includes a central portion with an extension at a predetermined position, and two lateral portions attached to the central portion; and   b. a fiducial frame attachable to the LADS by the extension for receiving the plurality of fiducial markers.   
     
     
         18 . The system of  claim 17 , wherein the infrared tracking system comprises a first optical emitter attachable to the surgical instrument, and a second optical emitter attachable to the LADS, and an optical tracker adapted for receiving optical signals from the first optical emitter and the second optical emitter. 
     
     
         19 . The system of  claim 18 , wherein each of the first and second optical emitters comprises an infrared emitter. 
     
     
         20 . The system of  claim 16 , wherein the imaging acquisition device comprises a CT scanning device. 
     
     
         21 . The system of  claim 16 , wherein the surgical instrument comprises a drill, and the distal end portion of the surgical instrument comprises the tip of the drill. 
     
     
         22 . The system of  claim 16 , wherein the surgical instrument comprises a surgical scalpel, and the distal end portion of the surgical instrument comprises the cutting portion of the surgical scalpel. 
     
     
         23 . The system of  claim 16 , wherein the controller is programmed to perform the steps of:
 a. identifying a centroid of each fiducial marker in the pre-operatively acquired image volume;   b. registering the identified centroid of each fiducial marker in the pre-operatively acquired image volume to the pre-operatively measured location of the corresponding fiducial marker in the anatomic space so as to determine a registration transformation; and   c. mapping the intra-operatively monitored location of the distal end portion of the surgical instrument in the anatomic space onto a corresponding location in the pre-operatively acquired image volume by an inverse of the registration transformation, thereby intra-operatively displaying the location of the distal end portion of the surgical instrument through the image displaying device.   
     
     
         24 . The system of  claim 23 , the controller is further programmed to perform the step of disabling the surgical instrument when the surgical instrument departs from the predetermined path. 
     
     
         25 . The system of  claim 16 , wherein the image displaying device comprises a monitor. 
     
     
         26 . The system of  claim 16 , wherein the access to the cochlea of the living subject is a single passage from the lateral edge of the skull to the cochlea. 
     
     
         27 .- 38 . (canceled) 
     
     
         39 . A system for providing an access to a cochlea of a living subject for performing a medical procedure, comprising:
 a. a platform;   b. means for pre-operatively determining a location for positioning the platform proximate to the cochlea of the living subject;   c. means for positioning the platform proximate to the pre-operatively determined location;   d. a surgical instrument guide for guiding a surgical instrument towards a region of interest of the living subject, wherein the surgical instrument has a distal end portion in operation reaching the region of interest first, for opening an access to the cochlea of the living subject; and   e. means for intra-operatively monitoring at least a location of the distal end portion of the surgical instrument so that the surgical instrument is operated substantially along a predetermined path.   
     
     
         40 . The system of  claim 39 , wherein the access to the cochlea of the living subject is a single passage from the lateral edge of the skull to the cochlea. 
     
     
         41 . The system of  claim 39 , further comprising means for performing a medical procedure through the access. 
     
     
         42 . The system of  claim 41 , wherein the means for performing a medical procedure comprises one of a cochlea implant, a drug delivery system, a carrier device, a medical detecting system, a medical treatment system, and any combination of them. 
     
     
         43 . The system of  claim 39 , wherein the platform comprises a fiducial frame with at least one fiducial marker. 
     
     
         44 . The system of  claim 43 , wherein the fiducial frame comprises a customized fiducial frame. 
     
     
         45 . The system of  claim 39 , further comprising means for operating the surgical instrument. 
     
     
         46 . The system of  claim 45 , wherein the operating means comprises a man-made device. 
     
     
         47 . The system of  claim 39 , wherein the surgical instrument guide comprises an infrared tracking system. 
     
     
         48 . The system of  claim 39 , wherein the surgical instrument comprises a drill, and the distal end portion of the surgical instrument comprises the tip of the drill. 
     
     
         49 . The system of  claim 39 , wherein the surgical instrument comprises a surgical scalpel, and the distal end portion of the surgical instrument comprises the cutting portion of the surgical scalpel. 
     
     
         50 . The system of  claim 39 , wherein the pre-operatively determining means comprises a controller and/or software stored on a computer readable medium for causing the controller to perform at least a registration procedure. 
     
     
         51 . The system of  claim 39 , wherein the intra-operatively monitoring means comprises a controller and/or software stored on a computer readable medium for causing the controller to perform at least an image-guided procedure. 
     
     
         52 . The system of  claim 51 , wherein the intra-operatively monitoring means further comprises an image displaying device in communication with the controller. 
     
     
         53 . The system of  claim 39 , further comprising means for disabling the surgical instrument when the surgical instrument departs from the predetermined path. 
     
     
         54 .- 56 . (canceled)