Cardiac methods and system

• US 6,298,257 B1
• Filed: 09/22/1999
• Issued: 10/02/2001
• Est. Priority Date: 09/22/1999
• Status: Expired due to Term

• Current Assignee: Stereotaxis, Inc.
• Original Assignee: Stereotaxis, Inc.
• Inventors: Blume, Walter M., Hall, Andrew F., Hastings, Roger N.
• Primary Examiner(s): Lateef, Marvin M.
• Assistant Examiner(s): MANTIS MERCADER, ELENI M
• Application Number:
  US09/405,314
• Time in Patent Office: 741 Days
• Field of Search: 600/424, 600/427, 600/407, 600/429, 600/374, 600/9, 600/11, 600/12, 600/13, 600/509, 600/114, 600/117, 606/130, 606/108, 128/899, 604/95, 604/891.1, 361/141, 361/143, 361/146
• US Class Current: 600/407
• CPC Class Codes: A61B 5/06 Devices, other than using radiation, for detecting or locating foreign bodies for removing same A61B17/50 ; determining position of probes within or on the body of the patient
• 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 5/062 using magnetic field
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/29 for permanent or long-term implantation
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders

Abstract

A method of applying a magnetic medical device to the surface of an internal body structure, the medical device having a magnetically responsive element associated with its distal end, the method comprising applying a magnetic field to the distal end of the magnetic medical device to apply a measured and controlled force between the medical device and tissue to facilitate cardiac sensing, mapping, pacing, ablation, biopsying and other procedures. Contact is confirmed by the angle between the direction of the magnetic medical device and the applied magnetic field, and the contact force is controlled by controlling at least one of the magnetic field direction and the magnetic field strength.

Claims

1. A method of applying a magnetic medical device to the surface of an internal body structure, the medical device having a magnetically responsive element associated with its distal end, the method comprising applying a magnetic field to the distal end of the magnetic medical device to apply a measured and controlled force between the medical device and tissue.

2. The method according to claim 1 wherein the force between the medical device and the tissue is controlled by varying at least one of the strength of the applied magnetic field and the direction of the applied magnetic field.

3. The method according to claim 1 wherein the force between the medical device and the tissue is controlled not to exceed a predetermined maximum bound.

4. The method according to claim 1 wherein the force between the medical device and the minimum is controlled to exceed the predetermined minimum bound.

5. A method of applying a magnetic medical device to the surface of an internal body structure, the medical device having a magnetically responsive element associated with its distal end, the method comprising applying a magnetic field to the distal end of the magnetic medical device to orient the distal end of the magnetic medical device generally toward the surface of the internal body structure, comparing the angle between the direction of the distal end of the magnetic medical device with the direction of the applied magnetic field;

and advancing the distal end of the magnetic medical device toward the surface of the internal body structure and/or adjusting the direction of the applied magnetic field until the angle between the direction of the distal end of the magnetic medical device and the applied magnetic field indicate that the magnetic medical device is in contact with the surface of the internal body structure.

6. The method according to claim 5 wherein the distal end of the magnetic medical device is advanced toward the surface of the internal body structure until the angle between the direction of the distal end of the magnetic medical device and the applied magnetic field indicate that the magnetic medical device is in contact with the surface of the internal body structure.

7. The method according to claim 5 wherein the direction of the applied magnetic field is adjusted until the angle between the direction of the distal end of the magnetic medical device and the applied magnetic field indicate that the magnetic medical device is in contact with the surface of the internal body structure.

8. The method according to claim 5 wherein the distal end of the magnetic medical device is advanced toward the surface of the internal body structure and the direction of the applied magnetic field is adjusted until the angle between the direction of the distal end of the magnetic medical device and the applied magnetic field indicate that the magnetic medical device is in contact with the surface of the internal body structure.

9. The method according to claim 5 wherein the magnetic medical device is advanced manually.

10. The method according to claim 5 wherein the magnetic medical device is advanced automatically.

11. The method according to claim 5 wherein the magnetic medical device is applied to the surface of a moving body structure, and wherein the distal end of the magnetic medical device is advanced toward the moving surface of the internal body structure until the angle between the direction of the distal end of the magnetic medical device and the applied magnetic field indicates that the magnetic medical device is in contact with the surface of the internal body structure during its entire range of motion.

12. The method according to claim 11 wherein the magnetic medical device is advanced automatically.

13. The method according to claim 11 wherein the magnetic medical device is advanced automatically.

14. A method of applying a magnetic medical device to the surface of an internal body structure with a predetermined minimum force, the medical device having a magnetically responsive element associated with its distal end, the method comprising applying a magnetic field to the distal end of the magnetic medical device to orient the distal end of the magnetic medical device generally toward the surface of the internal body structure, comparing the angle between the direction of the distal end of the magnetic medical device with the direction of the applied magnetic field;

and advancing the distal end of the magnetic medical device toward the surface of the internal body structure until the angle between the direction of the distal end of the magnetic medical device and the applied magnetic field indicate that the magnetic medical device is in contact with the surface of the internal body structure;

adjusting at least one of the applied magnetic field intensity and applied magnetic field direction so that the distal end of the magnetic medical device contacts the surface of the body structure with at least the predetermined minimum force.

15. The method according to claim 14 wherein only the magnetic field direction is adjusted.

16. The method according to claim 14 wherein only the magnetic field strength is adjusted.

17. The method according to claim 14 wherein both the magnetic field direction and the magnetic field intensity are adjusted.

18. The method according to claim 14 wherein the magnetic medical device is applied to the surface of a moving body structure, and at least one of the applied magnetic field intensity and applied magnetic field direction arc adjusted so that the distal end of the magnetic medical device contacts the surface of the body structure with at least the predetermined minimum force during its entire range of motion.

19. The method according to claim 18 wherein only the magnetic field direction is adjusted.

20. The method according to claim 18 wherein only the magnetic field strength is adjusted.

21. The method according to claim 18 wherein both the magnetic field direction and the magnetic field intensity are adjusted.

22. A method of mapping the surface of an internal body structure comprising successively applying a magnetic medical device, having a magnetically responsive element associated with its distal end, to a plurality of points on the surface of the internal body structure by magnetically navigating the distal end of the magnetic medical device into contact with each of the points on the surface of the body;

and determining the location of the distal end when the distal end is in contact with the surface as of the body structure as determined when the direction of the distal end of the magnetic medical device angle and the direction of the applied magnetic field exceeds a predetermined threshold.

23. The method according to claim 22 wherein the points are manually selected on an image of the structure.

24. The method according to claim 22 wherein the points are determined in a predetermined relationship to a selected point.

25. The method according to claim 22 wherein the magnetic medical device is magnetically navigated to contact a first point on the surface, successively retracted an magnetically directed into contact with the surface at one or more points by varying the magnetic field.

26. The method according to claim 22 wherein the magnetic medical device is automatically navigated to subsequent points based upon a mathematical model.

27. A method of mapping the moving surface of an internal body structure comprising successively applying a magnetic medical device, having a magnetically responsive element associated with its distal end, to a plurality of points on the moving surface of the internal body structure by magnetically navigating the distal end of the magnetic medical device into contact with each of the points on the surface of the body;

and determining the location of the distal end when the distal end is in contact with the surface as of the body structure as determined when the direction of the distal end of the magnetic medical device angle and the direction of the applied magnetic field exceeds a predetermined threshold, at a plurality of points during the movement of the surface.

28. The method according to claim 27 wherein the points are manually selected on an image of the structure.

29. The method according to claim 27 wherein the points are determined in a predetermined relationship to a selected point.

30. The method according to claim 27 wherein the magnetic medical device is magnetically navigated to contact a first point on the surface, successively retracted an magnetically directed into contact with the surface at one or more points by varying the magnetic field.

31. The method according to claim 27 wherein the magnetic medical device is automatically navigated to subsequent points based upon a mathematical model.

32. A method of physiologically mapping the surface of an internal body structure comprising successively applying a magnetic medical device, having a magnetically responsive element associated with its distal end, to a plurality of points on the surface of the internal body structure by magnetically navigating the distal end of the magnetic medical device into contact with each of the points on the surface of the body;

and determining the location of the distal end when the distal end is in contact with the surface as of the body structure as determined when the direction of the distal end of the magnetic medical device angle and the direction of the applied magnetic field exceeds a predetermined threshold, and measuring the physiological property at the determined location.

33. The method according to claim 32 wherein the points are manually selected on an image of the structure.

34. The method according to claim 33 wherein the points are determined in a predetermined relationship to a selected point.

35. The method according to claim 32 wherein the magnetic medical device is magnetically navigated to contact a first point on the surface, successively retracted and magnetically directed into contact with the surface at one or more points by varying the magnetic field.

36. The method according to claim 32 wherein the magnetic medical device is automatically navigated to subsequent points based upon a mathematical model.

37. The method according to claim 32 wherein the magnetic medical device is automatically navigated to subsequent points based upon the physiological data previously measured.

38. A system for making contact between a catheter and points on the surface of an internal body structure in which magnetic forces are applied;

a source magnet for applying a magnetic field of changeable direction and strength within an operating region in a patient;

a magnetic medical device adapted to be introduced into the operating region in the patient, having a magnet element, responsive to the magnetic field of the source magnet, associated with its distal end;

a localization device for determining the orientation of the distal end portion of the medical device;

a processor for comparing the direction of the distal end of the catheter and the direction of the applied magnetic field and adjusting the direction and/or strength of the magnetic field to cause the distal end of the magnetic medical device to press against the surface of the body structure with a predetermined force.

39. The system according to claim 38 further comprising a display for displaying the contact force between the magnetic medical device and the surface of the body structure.

40. A method of mapping a portion of a heart comprising the steps of:

orienting a magnetic medical device in the heart with an externally applied magnetic field, and contacting the magnetic medical device with the surface of the heart by advancing the medical device and/or changing the direction of an externally applied magnetic field until the angle between the direction of the applied magnetic field and the direction of the medical device indicates that the medical device is in contact with the surface of the heart;

measuring at least one physiological property of the heart at the point of contact with the magnetic medical device;

recording the measured physiological property;

determining the position of the distal end of the magnetic medical device; and

creating a map of the measured physiological properties and their locations.