Apparatuses and methods for endobronchial navigation to and confirmation of the location of a target tissue and percutaneous interception of the target tissue

• US 10,617,324 B2
• Filed: 10/11/2016
• Issued: 04/14/2020
• Est. Priority Date: 04/23/2014
• Status: Active Grant

• Current Assignee: Veran Medical Technologies, Inc. (Olympus Corporation)
• Original Assignee: Veran Medical Technologies, Inc. (Olympus Corporation)
• Inventors: Hunter, Mark, Holsing, Troy L.
• Primary Examiner(s): Hoffman, Joanne M
• Application Number:
  US15/290,822
• Publication Number:
  US 20170251951A1
• Time in Patent Office: 1,281 Days
• Field of Search: None
• CPC Class Codes: A61B 1/0005 combining images e.g. side-by-side, superimposed or tiled
• CPC Class Codes: A61B 1/2676 Bronchoscopes
• CPC Class Codes: A61B 10/04 Endoscopic instruments
• CPC Class Codes: A61B 2010/0208 Biopsy devices with actuators, e.g. with triggered spring mechanisms
• CPC Class Codes: A61B 2010/045 Needles pointed biopsy devices with vacuum aspiration A61B10/0283
• CPC Class Codes: A61B 2017/00699 correcting for movement caused by respiration, e.g. by triggering
• CPC Class Codes: A61B 2017/00809 Lung operations
• CPC Class Codes: A61B 2034/105 Modelling of the patient, e.g. for ligaments or bones
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2034/2055 Optical tracking systems
• CPC Class Codes: A61B 2034/301 for introducing or steering flexible instruments inserted into the body, e.g. catheters or endoscopes
• CPC Class Codes: A61B 2090/3925 ultrasonic
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 34/25 User interfaces for surgical systems
• CPC Class Codes: A61B 34/30 Surgical robots
• CPC Class Codes: A61B 5/061 Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body A61B1/00158 takes precedence
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/082 Evaluation by breath analysis, e.g. determination of the chemical composition of exhaled breath A61B5/083, A61B5/091 take precedence
• CPC Class Codes: A61B 5/1107 Measuring contraction of parts of the body, e.g. organ, muscle apparatus for measuring work or force in general G01L
• CPC Class Codes: A61B 5/1127 using markers
• CPC Class Codes: A61B 5/1128 : using image analysis A61B5/1127 takes precedence
• CPC Class Codes: A61B 5/113 : occurring during breathing

Abstract

A method of confirming the location of a target tissue within a patient using a navigation system is provided. The navigation system displays images from a pre-acquired image dataset and provides location information of a medical device within a patient in relation to a patient tracking device affixed to the patient. The method includes determining an initial location of the target tissue, navigating a steerable catheter through the airway of the patient to a position proximate the initial location, tracking the location of the steerable catheter in the airway using the navigation system, generating information regarding the presence of the target tissue using a tissue sensing device inserted into the steerable catheter, and determining a confirmed location of the target tissue in relation to the patient tracking device using the generated information regarding the presence of the target tissue and the tracked location of the steerable catheter.

Claims

1. A method of confirming the location of a target tissue within a patient using a navigation system, the navigation system comprising a localization device, an electromagnetic field generator, a display, and a pre-acquired image dataset of an airway of the patient, the navigation system being adapted to display images from the image dataset and to provide location information of a medical device within the patient in relation to a patient tracking device, the method comprising:

affixing the patient tracking device to an external surface of the patient, the patient tracking device comprising a plurality of pads wherein each pad is positioned at a different location on the external surface of the patient, and each pad has at least one marker positioned thereon and a location element positioned proximate to each marker, each location element being coupled to the localization device and configured to simultaneously send to the localization device position data associated with a plurality of positions in three-dimensional space of a first location element and position data associated with a plurality of positions in three-dimensional space of a second location element and position data associated with a plurality of positions in three-dimensional space of a third location element during a first time interval;

tracking the location of the patient tracking device using the navigation system;

displaying an image from the image dataset on the display, wherein the displayed image is registered to the patient tracking device;

determining an initial location of the target tissue in the image dataset;

navigating a steerable catheter through the airway of the patient to a position proximate the initial location, the steerable catheter having a proximal end portion and a distal end portion terminating in a tip, a working channel extending there between, and a catheter localization element disposed proximate the distal end portion thereof;

tracking the location of the catheter localization element of the steerable catheter in the airway using the navigation system;

generating information regarding the presence of the target tissue using a tissue sensing device inserted into the working channel of the steerable catheter;

determining a confirmed location of the target tissue in relation to the patient tracking device using the generated information regarding the presence of the target tissue and the tracked location of the catheter localization element;

recording the confirmed location of the target tissue; and

displaying the confirmed location of the target tissue on the display of the navigation system in an image from the image dataset.

2. The method of claim 1 further comprising the steps of:

displaying on the display of the navigation system a trajectory of a percutaneous device from an entry point on the patient to the confirmed location, the percutaneous device comprising a device localization element;

inserting the percutaneous device into the patient;

navigating the percutaneous device to the confirmed location; and

intercepting the target tissue at the confirmed location.

3. The method of claim 2 wherein the percutaneous device comprises a percutaneous needle having a cannula including a proximal end portion and a distal end portion terminating in a tip, a working channel extending there between, and wherein the device localization element is disposed proximate the distal end portion thereof.

4. The method of claim 2 wherein the percutaneous device comprises a thoracic wedge resection device and intercepting the target tissue comprises performing a thoracic wedge resection of the target tissue.

5. The method of claim 2 further comprising:

generating one or more images of at least a portion of the percutaneous device at the confirmed location of the target tissue using an imaging device inserted into the working channel of the steerable catheter.

6. The method of claim 2 further comprising:

generating one or more images of anatomical structures proximate the confirmed location of the target tissue using an imaging device inserted into the working channel of the steerable catheter;

confirming the location of the anatomical structures in relation to the patient tracking device using the generated images and the tracked location of the inserted steerable catheter;

recording the confirmed location of the anatomical structures in relation to the patient tracking device.

7. The method of claim 6 further comprising:

calculating a trajectory from the confirmed location of the target tissue to a corresponding entry point on the patient wherein the trajectory avoids some or all of the anatomical structures.

8. The method of claim 7 wherein the calculated trajectory is the shortest distance from the confirmed location of the target tissue to a corresponding calculated entry point on the patient.

9. The method of claim 7 further comprising displaying the calculated trajectory from the confirmed location of the target tissue to the corresponding calculated entry point on the patient.

10. The method of claim 7 wherein displaying a trajectory of the percutaneous device relative to the confirmed location of the target tissue on the display of navigation system further comprises displaying an extended trajectory of a medical device, wherein the medical device is disposed in the working channel of the percutaneous needle and is extended beyond the tip of the percutaneous needle, and wherein the extended trajectory displays the potential extension of the medical device so that it is confirmed that the extension will sample the target tissue and will not hit one or more anatomical structures.

11. The method of 1 further comprising:

matching an atlas model to the image dataset of the airway of the patient, the matching comprising deforming the atlas model to the image dataset of the airway of the patient, wherein the atlas model comprises anatomical structures;

identifying anatomical structures to be avoided by the trajectory of a percutaneous device; and

calculating a trajectory from the confirmed location of the target tissue to the corresponding entry point on the patient wherein the trajectory avoids some or all of the anatomical structures.

12. The method of claim 11 further comprising displaying the calculated trajectory from the confirmed location of the target tissue to the corresponding calculated entry point on the surface of the patient.

13. The method of claim 12 further comprising indicating a procedural position in which the patient must be to navigate the percutaneous needle along the calculated trajectory from the confirmed location of the target tissue to the corresponding calculated entry point on the patient.

14. The method of claim 11 further comprising:

navigating a needle connected to a robotic medical device to the calculated entry point on the surface of the patient;

inserting the needle into the patient at the calculated entry point on the surface of the patient; and

extending the needle to the confirmed location of the target tissue along the calculated trajectory.

15. A method of navigating a percutaneous needle to a target tissue within a patient using a navigation system, the navigation system comprising a localization device, an electromagnetic field generator, a display, and a pre-acquired image dataset of an airway of the patient, the navigation system being adapted to display images from the image dataset and to provide location information of a medical device within a patient in relation to a patient tracking device, the method comprising:

affixing the patient tracking device to an external surface of the patient, the patient tracking device comprises;

a first pad positioned at a first location on the external surface of the patient, a first marker positioned at a location on the first pad and a first location element coupled to the first pad proximate the first marker,

a second pad positioned at a second location on the external surface of the patient, a second marker positioned at a location on the second pad and a second location element coupled to the second pad proximate the second marker, and

a third pad positioned at a third location on the external surface of the patient, a third marker positioned at a location on the third pad and a third location element coupled to the third pad proximate the third marker,

the first element, the second element and the third element each being coupled to the localization device and configured to simultaneously send to the localization device position data associated with a plurality of positions in three-dimensional space of the first element, position data associated with a plurality of positions in three-dimensional space of the second element, and position data associated with a plurality of positions in three-dimensional space of the third element;

tracking the location of the patient tracking device using the navigation system to monitor the respiratory state of the patient;

displaying an image from the image dataset on the display as a function of the monitored respiratory state, wherein the displayed image is registered to the patient tracking device;

determining an initial location of the target tissue in the image dataset;

navigating a steerable catheter through the airway of the patient to a position proximate the initial location, the steerable catheter having a proximal end portion and a distal end portion terminating in a tip, a working channel extending there between, and a catheter localization element disposed proximate the distal end portion thereof;

tracking the location of the catheter localization element of the steerable catheter in the airway using the navigation system;

generating one or more images of the target tissue using an imaging device inserted into the working channel of the steerable catheter;

determining a confirmed location of the target tissue in relation to the patient tracking device using the generated images and the tracked location of the catheter localization element;

recording the confirmed location of the target tissue, the recording comprising four-dimensional data comprising a three-dimensional location of the confirmed target tissue in relation to the patient tracking device and the respiratory state of the patient at the time the location of the target tissue was confirmed and applying the confirmed location of the target tissue to an image from the image dataset depicting the airway at the respiratory state of the patient at the time the location of the target tissue was confirmed;

displaying the confirmed location of the target tissue on the display of the navigation system in an image from the image dataset, the displayed image depicting the airway at the respiratory state of the patient at the time the location of the target tissue was confirmed;

displaying a trajectory of a percutaneous device from an entry point on the patient'"'"'s body to the confirmed location on the display of the navigation system, the percutaneous device comprising a device localization element;

inserting the percutaneous device into the patient and navigating the percutaneous device to the confirmed location; and

intercepting the target tissue at the confirmed location.