Systems and methods for interventional medicine

• US 20050256398A1
• Filed: 05/12/2004
• Published: 11/17/2005
• Est. Priority Date: 05/12/2004
• Status: Abandoned Application

• Current Assignee: Stereotaxis, Inc.
• Original Assignee: Stereotaxis, Inc.
• Inventors: Klimek, Scott G., Riters, Rogers C., Viswanathan, Raju R., Blume, Walter M., Hall, Andrew F., Hastings, Roger N., Werp, Peter R., Rauch, John
• Application Number:
  US10/844,056
• Publication Number:
  US 20050256398A1
• Time in Patent Office: Days
• US Class Current: 600/423
• CPC Class Codes: A61B 2034/733 arranged only on one side of the patient, e.g. under a table
• CPC Class Codes: A61B 34/70 Manipulators specially adapted for use in surgery
• CPC Class Codes: A61B 34/73 Manipulators for magnetic surgery
• CPC Class Codes: A61B 90/36 Image-producing devices or illumination devices not otherwise provided for

Abstract

An automated system for navigating a medical device through the lumens and cavities in an operating region in a patient. The system includes an elongate medical device, having a proximal end and a distal end adapted to be introduced into the operating region. The system also includes an imaging system for displaying an image of the operating region, including a representation of the distal end of the medical device in the operating region. The system also includes a localization system for determining the position of the medical device in a frame of reference translatable to the displayed image of the imaging system. Finally, the system includes a system for orienting the medical device in a selected direction in the operating region, this system may be, for example, a magnetic navigation system which acts through the interaction of magnetic fields associated with the medical device inside the operating region and at least one external source magnet outside the patient'"'"'s body.

Claims

1. An automated system for navigating a medical device through the lumens and cavities in an operating region in a patient, the system comprising:

an elongate medical device, having a proximal end and a distal end adapted to be introduced into the operating region;

an imaging system for displaying an image of the operating region, including a representation of the distal end of the medical device in the operating region;

a localization system for determining the position of the medical device in a frame of reference translatable to the displayed image of the imaging system;

a magnetic navigation system for orienting the medical device in a selected direction in the operating region through the interaction of magnetic fields associated with the medical device inside the operating region and at least one external source magnet outside the patient'"'"'s body;

an advancer acting on the proximal end of the medical device for selectively advancing the distal end of the medical device;

an input device for receiving at least a destination for the distal end of the device input by the user using the displayed image of the imaging system;

and a controller, responsive to the destination input by the user, for operating the magnetic navigation system to orient the distal end of the medical device in the proper orientation to reach the selected destination, and once the distal end of the medical device is in the proper orientation, operating the advancer to advance the distal end of the medical device to the destination input by the user.

2. The system of claim 1 wherein the controller only operates the advancer after the magnetic navigation system has oriented the medical device in the selected direction.

3. The system of claim 1 wherein the imaging system includes an x-ray source and an x-ray detector for imaging the operating region.

4. The system of claim 1 wherein the imaging system is an MRI system that applies a magnetic field to the operating region, and wherein the magnetic navigation system comprises at least one coil in the distal end of the device for selectively changing the magnetic moment of the medical device.

5. An interventional medical system for guidance of medical devices within patient body lumens and cavities comprising:

a digitally controlled medical device advancer;

a digitally controlled medical device tip steering mechanism;

a means for determining the spatial coordinates of at least one point on the medical device adjacent the distal tip;

an imaging system which displays images of the operating region which include an image of the catheter superimposed on tissue;

a user interface that allows the operator to interact with the images to specify at least one of a location or a path;

a control computer that interprets operator specifications, and operates the medical device advancer and the medical device tip steering mechanism to guide the medical device to the specified location or along the specified path, and update the images of the catheter and tissue.

6. The system of claim 5 in which the catheter advancer includes a digitally controlled motor.

7. The system of claim 5 in which two or more catheter advancers simultaneously control two or more catheters.

8. The system of claim 5 in which the catheter steering mechanism is magnetic coupling between digitally controlled magnets external to the patient and a fixed magnetic material in the catheter tip.

9. The system of claim 5 in which the catheter steering mechanism is magnetic coupling between a fixed magnet external to the patient and a digitally controlled magnetic moment in the catheter tip.

10. The system of claim 5 in which the catheter steering mechanism is actuation of electrostrictive or magnetostrictive elements in the catheter tip.

11. The system of claim 5 in which the catheter steering mechanism is a combination of magnetic coupling between a fixed magnet external to the patient and a digitally controlled magnetic moment in the catheter tip, and actuation of electrostrictive elements in the catheter tip

12. The system of claim 5 in which the determination of spatial coordinates of the catheter is made by computer processing of digital images of the operating region.

13. The system of claim 5 in which the determination of spatial coordinates of the catheter is made by computer analysis of signals transmitted or received from within the catheter.

14. The system of claim 5 in which the images are X-ray fluoroscopic digitized or digital images.

15. The system of claim 5 in which the images are MRI images updated faster than once per second.

16. The system of claim 5 in which the images are local endoscopic images.

17. The system of claim 5 in which the catheter is steered and advanced or retracted to automatically maintain the relative position of the catheter tip and a point on tissue which is moving within the patient'"'"'s body.

18. The system of claim 5 in which the images are local ultrasound images.

19. The system of claim 5 in which the images are from a pre-operative MR or CT scan.

20. The system of claim 5 in which the images are a combination of real time and pre-operative images.

21. A method for navigating a medical device through the body lumens and cavities of a patient, consisting of:

observing the operating region and medical device on a composite medical image;

specifying desired points or paths for the medical device on a user interface;

navigation of a computer controlled steering and advancer means which advances the medical device to the specified points.

22. The method of claim 21 in which the catheter is retracted so that the tip moves along a specified line of tissue within the patient.

23. The method of claim 22 in which the a linear lesion is created to block atrial flutter.

24. The method of claim 21 in which the path is circular.

25. The method of claim 24 in which a circular of ablation is created adjacent the ostium of a pulmonary vein to block atrial fibrillation.

26. The method of claim 21 in which the catheter tip is moved in a path which keeps the tip stationary relative to a point on tissue which is moving within the patient.

27. The method of claim 26 in which the moving tissue is the heart.

28. The method of claim 27 in which the point on the heart is an ostium of a coronary blood vessel.

29. A method of navigating the distal end of a medical device in an operating region in a patient, the method comprising:

displaying an image of the operating region;

localizing the position of the distal end of the medical device in the operating region;

superposing a representation of the distal end of the medical device on the displayed image of the operating region;

accepting a destination for the distal end of the medical device input by the user using the displayed image of the operating region;

and iteratively localizing the position of the distal end of the medical device, orient determining the orientation for the distal end of the medical device to reach the destination input by the user, and orienting the distal end of the medical device in the determined orientation; and

automatically advancing the distal end of the medical device toward the destination until the distal end of the medical device is at the input destination.

30. A method of navigating the distal end of a medical device in an operating region in a patient, the method comprising:

displaying an image of the operating region;

localizing the position of the distal end of the medical device in the operating region;

superposing a representation of the distal end of the medical device on the displayed image of the operating region;

accepting a destination for the distal end of the medical device input by the user using the displayed image of the operating region;

determining the orientation for the distal end of the medical device to reach the destination input by the user, and orienting the distal end of the medical device in the determined orientation;

automatically advancing the distal end of the medical device toward the destination, and iteratively localizing the position of the distal end of the medical device, orient determining the orientation for the distal end of the medical device to reach the destination input by the user, and orienting the distal end of the medical device in the determined orientation; and

automatically advancing the distal end of the medical device toward the destination until the distal end of the medical device is at the input destination.

32. The method of claim 30 wherein the speed that the user can advance the medical device depends upon how close the orientation of the medical device is to the determined orientation.

31. A method of navigating the distal end of a medical device in an operating region in a patient, the method comprising:

displaying an image of the operating region;

localizing the position of the distal end of the medical device in the operating region;

superposing a representation of the distal end of the medical device on the displayed image of the operating region;

accepting a destination for the distal end of the medical device input by the user using the displayed image of the operating region; and

iteratively localizing the position of the distal end of the medical device, determining the orientation for the distal end of the medical device to reach the destination input by the user, and advancing the catheter upon input from the user.

33. A method of navigating the distal end of a medical device in an operating region in a patient, the method comprising:

displaying an image of the operating region;

localizing the position of the distal end of the medical device in the operating region;

superposing a representation of the distal end of the medical device on the displayed image of the operating region;

accepting a path for the distal end of the medical device input by the user using the displayed image of the operating region;

and iteratively localizing the position of the distal end of the medical device, determining the orientation for the distal end of the medical device to follow the path input by the user, and orienting the distal end of the medical device in the determined orientation; and

automatically advancing the distal end of the medical device along the path.

34. The method of claim 33 wherein the path is input as a series of points.

35. The method according to claim 33 further comprising the step of making a preoperative imaging showing the patients'"'"' vasculature;

and wherein the step of orienting and iteratively localizing the position of the distal end of the medical device, determining the orientation for the distal end of the medical device to reach the destination input by the user and orienting the distal end of the medical device in the determined orientation includes orienting the distal end of the device to travel in the patient'"'"'s vasculature in the preoperative image.

36. A method of navigating the distal end of a medical device in an operating region in a patient, the method comprising:

creating a preoperative image of the operating region;

localizing the position of the distal end of the medical device in the operating region;

superposing a representation of the distal end of the medical device on the displayed image of the operating region;

accepting a destination for the distal end of the medical device input by the user using the displayed image of the operating region;

and iteratively localizing the position of the distal end of the medical device, orient determining the orientation for the distal end of the medical device to reach the destination input by the user, and orienting the distal end of the medical device in the determined orientation; and

automatically advancing the distal end of the medical device toward the destination until the distal end of the medical device is at the input destination.

37. A method of navigating the distal end of a medical device in an operating region in a patient, the method comprising:

creating a preoperative image of the operating region;

localizing the position of the distal end of the medical device in the operating region;

superposing a representation of the distal end of the medical device on the displayed image of the operating region;

accepting a destination for the distal end of the medical device input by the user using the displayed image of the operating region;

and iteratively localizing the position of the distal end of the medical device, orient determining the orientation for the distal end of the medical device to reach the destination input by the user, and orienting the distal end of the medical device in the determined orientation; and

automatically advancing the distal end of the medical device toward the destination until the distal end of the medical device is at the input destination.

38. A method of controlling movement and navigation of a medical device inserted into a patient, said method comprising:

(a) localization of the device tip, said device exhibiting deflection capability in response to application of external magnetic fields, (b) using localization information together with device elasticity properties to magnetically guide the device tip to a desired location by suitable application of magnetic fields together with device advancement/retraction, and (c) said guidance implemented by the use of feedback control algorithms based on the construction of mathematical models of the interaction of device elasticity and applied external forces and torques on said device.

39. The method of claim 38, where said deflection capability is achieved by the use of a permanent magnet located within said device.

40. The method of claim 38, where said external forces in said mathematical models include gravitational forces.

41. The method of claim 38, where said external forces and torques included in said mathematical models arise from application of external magnetic fields.

42. The method of claim 38, where said feedback control algorithms utilize information obtained from pre-operative X-ray imaging.

43. The method of claim 38, where said feedback control algorithms utilize information obtained from intra-operative X-ray imaging.

44. The method of claim 38, where said device includes at least one force sensor at the device tip providing contact force data for incorporation into said mathematical models.

45. The method of claim 44, where said mathematical model includes tip contact forces.

46. The method of claim 45, where said mathematical model includes tip contact forces.

47. The method of claim 46, where said feedback control algorithms utilize contact force data.

48. The method of claim 47, where said feedback control algorithms utilize contact force data.

49. The method of claim 38, where said device advancement/retraction is achieved by computer control of an advancement/retraction system.

50. The method of claim 38, where said medical device is a catheter.

51. A system for closed-loop feedback control of medical device steering and advancement, said system including:

(a) a device localization sub-system for obtaining localization information at the device tip, (b) computer control of device advancement/retraction, (c) computer-controlled means of magnetic field application, (d) software and hardware for feedback control of catheter motion, said software including feedback control algorithms based on physics-based mathematical models of device elasticity, (e) automated computer control of device advancement and magnetic field application achieved by the use of localization data in conjunction with feedback control algorithms, and (f) a manual over-ride option for use in manual or semi-automated mode.

52. The system of claim 51, where said feedback control algorithms utilize information obtained from pre-operative X-ray imaging.

53. The system of claim 51, where said feedback control algorithms utilize information obtained from intra-operative X-ray imaging.

54. The system of claim 51 which includes a device localization subsystem for obtaining localization and orientation information at the device tip.