Systems and methods for navigation and simulation of minimally invasive therapy

• US 10,433,763 B2
• Filed: 03/14/2014
• Issued: 10/08/2019
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Synaptive Medical (Barbados) Inc.
• Original Assignee: Synaptive Medical (Barbados) Inc.
• Inventors: Piron, Cameron, Wood, Michael, Sela, Gal, Richmond, Joshua, Yuwaraj, Murugathas, Thomas, Monroe M., Hodges, Wes, Alexander, Simon, Gallop, David, Panther, Alex, Shanmugaratnam, Nishanthan, Lau, William
• Primary Examiner(s): Akar, Serkan
• Assistant Examiner(s): Gupta, Vani
• Application Number:
  US14/655,814
• Publication Number:
  US 20150351860A1
• Time in Patent Office: 2,034 Days
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 2034/107 Visualisation of planned trajectories or target regions
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2034/2053 Tracking an applied voltage gradient
• CPC Class Codes: A61B 2034/2055 Optical tracking systems
• CPC Class Codes: A61B 2034/2063 Acoustic tracking systems, e.g. using ultrasound
• CPC Class Codes: A61B 2090/103 Cranial plugs for access to brain
• CPC Class Codes: A61B 2090/365 augmented reality, i.e. correlating a live optical image with another image
• CPC Class Codes: A61B 2090/3735 Optical coherence tomography [OCT]
• CPC Class Codes: A61B 2090/3762 using computed tomography systems [CT]
• CPC Class Codes: A61B 2090/3782 transmitter or receiver in catheter or minimal invasive instrument
• CPC Class Codes: A61B 2090/3983 Reference marker arrangements for use with image guided surgery
• CPC Class Codes: A61B 2090/571 for clamping a support arm to a bed or other supports
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 5/0042 for the brain
• CPC Class Codes: A61B 5/0095 by applying light and detecting acoustic waves, i.e. photoacoustic measurements
• CPC Class Codes: A61B 5/055 involving electronic [EMR] or nuclear [NMR] magnetic resonance, e.g. magnetic resonance imaging
• CPC Class Codes: A61B 5/065 Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 90/50 : Supports for surgical instruments, e.g. articulated arms
• CPC Class Codes: A61B 90/90 : Identification means for patients or instruments, e.g. tags
• CPC Class Codes: A61N 1/0534 : Electrodes for deep brain stimulation

Abstract

Disclosed herein is navigation and simulation systems and methods for minimally invasive therapy in which the navigation system imports a planning method using patient specific pre-operative images. The navigation system uses intraoperative imaging during the medical procedure to update the preoperative images and provides images of tracked surgical tools along the surgical path prepared from the preoperative images.

Claims

1. A system for supporting a medical procedure, comprising:

a navigation module, comprising a navigation system, configured to control trajectory and visual display of at least one medical instrument, said navigation module comprising a power supply, a processor control module programmed with navigation control software, and a storage device connected to said processor control module, said storage device having stored therein a surgical trajectory path plan defining a surgical path to be followed on an anatomical part undergoing a medical procedure, and the at least one medical instrument comprising at least one uniquely identifiable tracking marker associated therewith, and the storage device configured to store;

a virtual representation of the at least one medical instrument stored in said storage device with the at least one associated uniquely identifiable tracking marker, said virtual representation of the at least one medical instrument being geometrically accurate with respect to volume, size, and shape of the at least one medical instrument; and

a virtual representation of at least one tissue structure of interest of the anatomical part from said surgical trajectory path plan stored in said storage device;

a tracking system in communication with said navigation system which determines spatial positioning of said at least one medical instrument using said at least one associated uniquely identifiable tracking marker, the tracking system comprising a 3D optical tracking stereo camera,

said processor control module programmed with instructions to compare the at least one medical instrument, being tracked, with said geometrically accurate virtual representation of said at least one medical instrument stored in said storage device for identifying the at least one medical instrument in use, to adaptively update a section of a preoperative image by using a localized intraoperative image, calculate a course change from an actual surgical path back to the surgical path defined by the surgical trajectory path plan, and match the virtual representation of the at least one tissue structure with an actual view of the at least one tissue structure of interest;

at least one display for displaying a superposition of a virtual representation of the surgical path defined by the surgical trajectory path plan and a virtual representation of the actual surgical path, preoperative imaging data of the anatomical part undergoing the medical procedure which is registered with the anatomical part, an image of said at least one medical instrument used in the medical procedure, the virtual representation of at least one tissue structure from said surgical trajectory path plan, the matched virtual representation of the at least one tissue structure with the actual view of the at least one tissue structure of interest, said course change from the virtual representation of the actual surgical path back to the virtual representation of the surgical path defined by the surgical trajectory path plan, the preoperative imaging data comprising diffusion tensor imaging data, the diffusion tensor imaging data comprising at least four dimensions of information, and the at least four dimensions of information comprising three spatial dimensions and a time dimension,

said navigation system comprising a guidance mechanism for visually assisting a surgeon to translate one medical instrument of the at least one medical instrument, being tracked by said tracking system, along the surgical path, and

the navigation module programmed to use said intraoperative imaging data of a localized region for updating said preoperative imaging data of said localized region within the anatomical part to update imaging of intra-operative tissue structures,

whereby real-time feedback is providable, the real-time feedback comprising at least one spatially correlated color map corresponding to at least one spectral signature from acquired intraoperative information;

further comprising at least one imaging device configured to acquire intraoperative imaging data of a localized region within the anatomical part during the medical procedure, said at least one imaging device including at least one uniquely identifiable tracking marker associated therewith which is tracked by said tracking system, wherein said navigation module update the preoperative imaging data of said localized region within the anatomical part during the medical procedure based on positional information of the tracked imaging device relative to the anatomical part;

wherein said preoperative imaging data are acquired using MRI, wherein said imaging device is an insertable MRI device configured to be inserted into the anatomical part, and wherein the navigation module is programmed to adaptively update a section of the MRI acquired preoperative imaging data using localized intraoperative MRI imaging data acquired using said insertable MRI device.

2. The system according to claim 1, wherein the navigation module is programmed to provide positionally accurate maps correlating intraoperative imaging data acquired during the medical procedure to locations where the intraoperative imaging data is acquired in the anatomical part.

3. The system according to claim 2, wherein the navigation module is programmed to represent the positionally accurate maps by spatially correlated color maps.

4. The system according to claim 1, wherein the navigation module is programmed to enable quantitative registration in which an absolute quantitative metric is measured intraoperatively and to use the absolute quantitative metric to register imaging data obtained using one or more imaging modalities.

5. The system according to claim 4, wherein the absolute quantitative metric comprises at least one of:

MRI (T1), MRI (T2), cell density, tissue density, tissue anisotropy, tissue stiffness, fluid flow per volume or area, electrical conductivity, pH, and pressure.

6. The system according to claim 1, wherein the navigation module is programmed with instructions to compute biomechanical properties of tissue being imaged by said at least one imaging device and to use said computed biomechanical properties to update a tissue model of the anatomical part undergoing the medical procedure.

7. The system according to claim 1, wherein the navigation module is programmed with instructions to analyze tissue patterns from the intraoperative imaging data acquired by said at least one imaging device and to compare the tissue patterns from the intraoperative imaging data acquired by said at least one imaging device with the preoperative imaging data, whereby a comparison is providable, and, based on said comparison, to generate a deformed preoperative model of the anatomical part.

8. The system according to claim 1, wherein said imaging device comprises one of:

an ultrasound imaging device, an optical coherence tomography imaging device, a photo acoustic imaging device, and an optical imaging device.

9. The system according to claim 1,

wherein said at least one imaging device is configured for imaging tissue structures, and

wherein the navigation module is programmed with instructions to use the intraoperative imaging data of imaged tissue structures to update the preoperative imaging data of the tissue structures.

10. The system according to claim 1,

wherein the anatomical part undergoing the medical procedure is a patient'"'"'s brain, wherein the medical procedure is a port based surgery utilizing a port and introducer, and

wherein the surgical path is a multi-segment surgical path defined by a multi-segment surgical trajectory path plan.

11. The system according to claim 10,

wherein said at least one imaging device is configured for imaging at least one tissue structure of the brain, and

wherein the at least one tissue structure of the brain comprises at least one of:

brain fiber tracts, sulci structures, nerve fascicles, and blood vessels.

12. The system according to claim 1, wherein the navigation module is programmed with instructions for:

comparing the preoperative imaging data and the intraoperative imaging data;

detecting discrepancies between the preoperative imaging data and the intraoperative imaging data; and

upon detecting discrepancies, performing a scan to update at least one of volumetric scans and CT scans,

whereby at least one of preoperative scanning volumes and intraoperative scanning volumes are updatable.

13. The system according to claim 12, wherein the navigation module is programmed for comparing and detecting discrepancies between the preoperative imaging data and the intraoperative imaging data by matching at least one of sulcal patterns, blood vessel positions, and, by quantifiable common contrast mechanisms, elastic modulus, tissue anisotropy, and blood-flow.

14. The system according to claim 1, wherein the navigation module is programmed to visually display preoperative imaging data, intraoperative imaging data, a superposition of the preoperative and intraoperative imaging data, the virtual representation of the surgical path defined by the surgical trajectory path plan in both the preoperative and intraoperative imaging data, and a virtual representation of an actual surgical path calculated by the navigation module based on the intraoperative imaging data.

15. The system according to claim 14, wherein said calculated and displayed course change from the actual surgical path back to the surgical path defined by the surgical trajectory path plan is consistent with surgical outcome criteria associated with the surgical trajectory path plan with respect to regions of the anatomical part to be avoided or approached.

16. The system according to claim 1, wherein the at least one tissue structure from said surgical trajectory path plan comprises at least one of:

fiber tracts, sulci structures, nerve fascicles, and blood vessels.

17. A system for supporting a medical procedure on a patient, comprising:

a navigation module, comprising a navigation system, configured to control trajectory and visual display of at least one medical instrument, said navigation module comprising a power supply, a processor control module programmed with navigation control software, and a storage device connected to said processor control module, said storage device having stored therein a surgical trajectory path plan defining a surgical path to be followed on an anatomical part undergoing the medical procedure and preoperative imaging data of the anatomical part of the patient undergoing the medical procedure, each at least one medical instrument comprising at least one uniquely identifiable tracking marker associated therewith, and the storage device configured to store;

a virtual representation of said at least one medical instrument with its associated at least one uniquely identifiable tracking marker, said virtual representation of said at least one medical instrument being geometrically accurate with respect to size and shape of the at least one medical instrument; and

a virtual representation of at least one tissue structure from said surgical trajectory path plan stored in said storage device;

a tracking camera in communication with said navigation system for determining spatial positioning of said at least one medical instrument using said at least one uniquely identifiable tracking marker and associated virtual representation relative to said registered anatomical part, the tracking camera comprising a 3D optical tracking stereo camera;

said processor control module programmed with instructions for;

comparing at least one medical instrument, being tracked, with said geometrically accurate virtual representation of said at least one medical instrument stored in said storage device for;

identifying the at least one medical instrument in use, adaptively updating a section of a preoperative image by using a localized intraoperative image, calculating a course change from an actual surgical path back to the surgical path defined by the surgical trajectory path plan, and matching the virtual representation of the at least one tissue structure with an actual view of at least one tissue structure of interest;

at least one display for displaying;

a superposition of a virtual representation of the surgical path defined by the surgical plan and a virtual representation of the actual surgical path, the preoperative imaging data of the anatomical part undergoing the medical procedure which is registered with the anatomical part, an image of said at least one medical instrument used in the medical procedure, said virtual representation of at least one tissue structure from said surgical trajectory path plan, the matched virtual representation of the at least one tissue structure with the actual view of the at least one tissue structure of interest, said course change from the virtual representation of the actual surgical path back to the virtual representation of the surgical path defined by the surgical trajectory path plan, the preoperative imaging data comprising diffusion tensor imaging data, the diffusion tensor imaging data comprising at least four dimensions of information, and the at least four dimensions of information comprising three spatial dimensions and a time dimension;

an imaging device configured to acquire intraoperative imaging data of a localized region within the anatomical part, said imaging device comprising at least one uniquely identifiable tracking marker associated therewith tracked by said tracking camera; and

the navigation module programmed with instructions to use the intraoperative imaging data of said localized region for updating the preoperative imaging data of said localized region within the anatomical part during the medical procedure based on positional information of the tracked imaging device relative to the anatomical part,

whereby real-time feedback is providable, the real-time feedback comprising at least one spatially correlated color map corresponding to at least one spectral signature from acquired intraoperative information, further comprising at least one imaging device configured to acquire intraoperative imaging data of a localized region within the anatomical part during the medical procedure, said at least one imaging device including at least one uniquely identifiable tracking marker associated therewith which is tracked by said tracking system, wherein said navigation module update the preoperative imaging data of said localized region within the anatomical part during the medical procedure based on positional information of the tracked image device relative to the anatomical part;

wherein said preoperative imaging data are acquired using MRI, wherein said imaging device is an insertable MRI device inserted into the anatomical part, and wherein the navigation module is programmed to adaptively update a section of the MRI acquired preoperative imaging data using localized intraoperative MRI imaging data acquired using said insertable MRI device.