Methods and apparatus for steering medical device in body lumens

• US 7,627,361 B2
• Filed: 08/23/2005
• Issued: 12/01/2009
• Est. Priority Date: 08/24/2004
• Status: Active Grant

• Current Assignee: Stereotaxis, Inc.
• Original Assignee: Stereotaxis, Inc.
• Inventors: Viswanathan, Raju R.
• Primary Examiner(s): Casler; Brian
• Assistant Examiner(s): Shahrestani; Nasir
• Application Number:
  US11/211,155
• Publication Number:
  US 20060074297A1
• Time in Patent Office: 1,561 Days
• Field of Search: 600/407, 600/417, 600/424, 600/431, 600/427, 600/117, 600/373, 600/508, 606/108, 606/130, 128/897, 128/898, 128/899, 324/207.13, 324/207.22, 324/260
• US Class Current: 600/424
• 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 2034/2065 Tracking using image or pattern recognition
• 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 34/25 User interfaces for surgical systems
• CPC Class Codes: A61B 34/70 Manipulators specially adapted for use in surgery
• CPC Class Codes: A61B 34/73 Manipulators for magnetic surgery

Abstract

A method of operating a navigation system that can orient the distal end of a medical device in a selected direction to navigate the medical device through a network of body lumens in an operating region in a subject that includes identifying a path through the network of body lumens in the operating region; displaying a two-dimensional image of the operating region including the path through the body lumens; determining at least one location on the path; and operating the navigation system to orient the distal end of the medical device in a direction substantially aligned with the path at the at least one location and advancing the distal end of the medical device.

Claims

1. A method of operating a navigation system that can orient the distal end of a medical device in a selected direction at a plurality of intervals along a portion of a body lumen, to navigate the medical device through a portion of a body lumen in an operating region in a subject, the method comprising:

using a computer to perform the following steps;

identifying a plurality of spaced apart nodes that define a centerline along a desired path through a portion of the body lumen in the operating region;

selecting a node from the plurality of spaced apart nodes as a desired target location on the identified path;

backtracking at least a predetermined distance from the selected node, such that a length of the centerline is chosen for calculation of a deflection angle;

selecting a set of nodes within the predetermined distance preceding the selected node;

determining the distal end location of the medical device;

determining a distal end deflection angle at which to orient the distal end of the medical device based on the selected set of nodes, to obtain a good alignment of the distal end with the centerline of the path; and

computing control variables, based on the determined distal end deflection angle, that are applied to the navigation system to operate the navigation system to orient the distal end of the medical device in a direction along the path and advancing the distal end of the medical device; and

repeating the steps of determining the distal end location, determining a distal end deflection angle, and computing control variables for operating the navigation system for orienting the distal end at a plurality of intervals along the body lumen, to navigate the medical device through the body lumen.

2. The method according to claim 1 wherein the centerline along the desired path is identified by identifying points on the path on at least two images of the operating region.

3. The method according to claim 1 wherein the centerline along the desired path is identified by identifying lines on the path on at least two images of the operating region.

4. The method according to claim 1 where the centerline along the desired path is determined from an idealized anatomical model.

5. The method according to claim 1 where the centerline along the desired path is determined from a three dimensional dataset.

6. The method of claim 1 where the selection of the node as the desired target location on the path is done by determining the current location of the distal end of the medical device.

7. The method according to claim 6 wherein the current location of the distal end of the medical device is determined from image processing.

8. The method according to claim 6 wherein the current location of the distal end of the medical device is determined with a localization system.

9. The method according to claim 6 wherein the current location of the distal end of the medical device is determined with a length tracking system.

10. The method according to claim 1 wherein the distal end of the medical device is advanced by manually advancing the proximal end of the medical device.

11. The method according to claim 1 wherein the distal end of the medical device is advanced with a machine that advances the proximal end of the medical device.

12. The method according to claim 11 wherein the steps of computing control variables for operating the navigation system to orient the distal end of the medical device in a direction along the path and advancing the distal end of the medical device comprises:

repeatedly determining the location of the distal end of the medical device and orienting the medical device at the determined location to follow the determined path; and

advancing the medical device.

13. The method according to claim 12 wherein the location of the distal end of the medical device is determined continuously.

14. The method according to claim 12 wherein the location of the distal end of the medical device is determined at predetermined time intervals.

15. The method according to claim 14 wherein the predetermined time intervals are dynamically adjusted depending upon the curvature of the path.

16. The method according to claim 14 wherein the speed of the advancement is controlled based upon the curvature of the path.

17. The method according to claim 12 wherein the location of the distal end of the medical device is determined at predetermined distance intervals, as determined from the advancement of the distal end of the medical device.

18. The method according to claim 17 wherein the predetermined distance intervals are dynamically adjusted depending upon the curvature of the path.

21. The method according to claim 16 wherein the determined deflection angle changes for each of the plurality of intervals along the portion of the body lumen.

19. A method of operating in a stepwise mode a navigation system that can orient the distal end of a medical device in a selected direction at a plurality of intervals along a path through a portion of a body lumen, to navigate the medical device through a portion of a body lumen in an operating region in a subject, the method comprising:

(a) using a computer to perform the following steps;

(b) identifying a centerline of a path through an idealized model of the body lumen, where the centerline is defined by plurality of spaced apart nodes;

(c) selecting a node from the plurality of spaced apart nodes as a desired location on the path for device tip alignment with the path;

(d) backtracking at least a predetermined distance from the selected node, such that a length of the centerline is chosen for calculation of a deflection angle;

(e) selecting a set of nodes within the predetermined distance preceding the selected node;

(f) determining a deflection angle at which to orient the distal end of the medical device to obtain a good alignment with the centerline of the path, based on the selected set of nodes;

(g) computing control variables, based on the determined deflection angle, that are a lied to the navigation system to operate the navigation system to orient the distal end of the medical device in a direction along the path of the idealized model of the body lumen at the determined location and advancing the distal end of the medical device; and

(h) repeating steps (b) through (g) at a plurality of intervals along the portion of the body lumen as needed to navigate the medical device through the body lumen.

20. A method of operating a navigation system that can orient the distal end of a medical device in a selected direction at a plurality of intervals along a path through a portion of a body lumen, to navigate the medical device through a portion of a body lumen in an operating region in a subject, the method comprising:

(a) using a computer to perform the following steps;

(b) identifying a centerline of a path through a portion of the body lumen in the operating region, where the centerline is defined by plurality of spaced apart nodes;

(c) displaying a two-dimensional image of the operating region including the path through the body lumen;

(d) accepting via the two-dimensional image displayed a selection from the plurality of spaced apart nodes that is near a desired target in the portion of the body lumen in the operating region;

(e) backtracking at least a predetermined distance from the selected node, such that a length of the centerline is chosen for calculation of a deflection angle;

(f) selecting a set of nodes within the predetermined distance preceding the selected node;

(g) determining the current location of the distal end of the medical device;

(h) determining a deflection angle based on the selected set of nodes, which angle includes some amount of precession, for orienting the distal end of the medical device at the determined deflection angle with respect to the centerline of the path so as to orient the distal end other than along the centerline of the desired path;

(i) computing control variables, based on the determined deflection angle, that are applied to the navigation system to operate the navigation system to orient the distal end of the medical device in a direction at a predetermined angle with respect to the centerline of the path and advancing the distal end of the medical device.

22. A method of operating in a continuous mode a navigation system that can orient the distal end of a medical device in a selected direction at a plurality of intervals along a path through a portion of a body lumen, to navigate the medical device through a portion of a body lumen in an operating region in a subject, the method comprising:

(a) using a computer to perform the following steps;

(b) identifying a centerline of a path through a portion of the body lumen in the operating region, where the centerline is defined by plurality of spaced apart nodes;

(c) displaying a two-dimensional image of the operating region including the path through the body lumen;

(d) selecting a node from the plurality of nodes as a desired target location on the path for device tip alignment with the path;

(e) backtracking at least a predetermined distance from the selected node, such that a length of the centerline is chosen for calculation of a deflection angle;

(f) selecting a set of nodes within the predetermined distance preceding the selected node, from which set of nodes a set of curvatures may be defined;

(g) determining a deflection angle at which to orient the distal end of the medical device to obtain a good alignment with the centerline of the path direction for a discrete interval based on the local degree of curvature in the selected set of nodes;

(h) computing control variables, based on the determined deflection angle, that are applied to the navigation system to operate the navigation system to orient the distal end of the medical device in a direction substantially aligned with the path direction at the discrete interval; and

(i) automatically repeating steps (d) through (h) for the plurality of intervals along the portion of the body lumen as needed to automatically navigate the medical device through the body lumen.

23. A method of operating a navigation system that can orient the distal end of a medical device in a selected direction at a plurality of intervals along a path through a portion of a body lumen, to navigate the medical device through a portion of a body lumen in an operating region in a subject, the method comprising:

using a computer to perform the following steps;

determining a three dimensional configuration of the portion of the body lumen in the operating region;

displaying a two-dimensional image of the operating region including the portion of the body lumen;

accepting a selection from the two-dimensional display of a point on the portion of the body lumen in the operating region;

determining the corresponding three dimensional location of the point selected on the two dimensional display;

determining the current location of the distal end of the medical device;

defining a centerline of the path through the portion of a body lumen, where the centerline is defined by a plurality of spaced apart nodes;

backtracking at least a predetermined distance from the selected point on the portion of the body lumen, such that a length of the centerline is chosen for calculation of a deflection angle;

selecting a set of nodes within the predetermined distance preceding the selected node;

repeatedly determining a deflection angle based on the selected set of nodes, for orienting the distal end of the medical device to obtain a good alignment of the medical device with the centerline at a plurality of intervals along the path through the body lumen from the current location of the distal end of the medical device to the three dimensional location corresponding to the point selected on the two dimensional display;

and

computing control variables, based on the determined deflection angle, that are applied to the navigation system to operate the navigation system to repeatedly orient the distal end of the medical device in a direction along the path at the plurality of intervals, and advancing the distal end of the medical device.

24. The method according to claim 23 wherein the distal end of the medical device is advanced by manually advancing the proximal end of the medical device.

25. The method according to claim 23 wherein the distal end of the medical device is advanced with a machine that advances the proximal end of the medical device.

26. The method according to claim 23 wherein the steps of computing control variables for operating the navigation system to orient the distal end of the medical device in a direction along the path and advancing the distal end of the medical device comprises:

repeatedly determining the location of the distal end of the medical device and determining the orientation of the medical device in the determined location to follow the determined path; and

advancing the medical device.

27. The method according to claim 23 wherein the location of the distal end of the medical device is determined continuously.

28. The method according to claim 23 wherein the location of the distal end of the medical device is determined at predetermined time intervals.

29. The method according to claim 23 wherein the location of the distal end of the medical device is determined at predetermined distance intervals, as determined from the advancement of the distal end of the medical device.