System and method to determine the location and orientation of an indwelling medical device

• US 6,263,230 B1
• Filed: 11/06/1998
• Issued: 07/17/2001
• Est. Priority Date: 05/08/1997
• Status: Expired due to Term

• Current Assignee: BARD Access Systems Incorporated (Becton, Dickinson & Co)
• Original Assignee: Lucent Medical Systems, Inc.
• Inventors: Sanders, Gary B., Golden, Robert N., Haynor, David R., Somogyi, Christopher P.
• Primary Examiner(s): Lateef, Marvin M.
• Assistant Examiner(s): SHAW, SHAWNA JEANNINE
• Application Number:
  US09/188,049
• Time in Patent Office: 984 Days
• Field of Search: 600/407, 600/424, 600/585, 600/408, 600/117, 600/409, 128/899, 324/207.13, 324/207.17, 324/247, 324/326, 324/260, 324/244
• US Class Current: 600/424
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2090/376 using X-rays, e.g. fluoroscopy
• CPC Class Codes: A61B 2090/3958 emitting a signal
• 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 34/25 User interfaces for surgical systems
• CPC Class Codes: A61B 5/062 using magnetic field
• CPC Class Codes: G01V 3/08 operating with magnetic or electric fields produced or modified by objects or geological structures or by detecting devices with electromagnetic waves G01V3/12

Abstract

A device to detect the location of a plurality of magnets uses a plurality of magnetic sensors, having sensor elements arranged in a known fashion. Each sensor element senses the magnetic field strength generated by each of the plurality of magnets and provides data indicative of the direction of the magnets in a three-dimensional space. The device uses fundamental equations for electricity and magnetism that relate the measured magnetic field strength to the location and strength of the magnetic dipole for each of the plurality of magnets. The device may use an iterative process to determine the actual location and orientation of each magnet. An initial estimation of the location and orientation of each magnet results in the generation of predicted magnetic field values. The predicted magnetic field values are compared with the actual measured values provided by the magnetic sensors. Based on a difference between the predicted values and the measured values, the device estimates a new location for each of the magnets and calculates new predicted magnetic field strength values. The iteration process continues until the predicted values match the measured values within a desired degree of tolerance. At this point, the estimated location and orientation of each of the magnets matches the actual location within a predetermined degree of tolerance.

Claims

1. A system for detecting a position of a plurality of magnets within a patient from a measurement location outside the patient, the system comprising:

a housing;

a plurality of magnetic sensors supported by the housing, each of the plurality of sensors being oriented in a known direction and generating a set of signals as a function of static magnetic field strength and direction due to the plurality of magnets within the patient;

a processor configured to calculate an estimated position of each of the plurality of magnets in a three-dimensional space and to calculate values of a predicted magnetic field strength for at least a portion of the plurality of sensors based on the estimated positions of each of the plurality of magnets, the processor further configured to calculate values of an actual magnetic field strength using the set of signals and determining values of the location of each of the plurality of magnets based on the difference between the values of the predicted magnetic field strength and the values of the actual magnetic field strength; and

a display providing a visual display of the position of each of the plurality of magnets in the three-dimensional space.

2. The system of claim 1 wherein the processor calculates the estimated position using signals from selected ones of the plurality of magnetic sensors whose signals are above a predetermined threshold.

3. The system of claim 2 wherein plurality of magnetic sensors is greater than four magnetic sensors and the processor calculates the estimated position using signals from four of the magnetic sensors whose signals are above a predetermined threshold.

4. The system of claim 1, the system further including a neural network to generate the estimated position, the neural network receiving at least a portion of the set of signals and generating the estimated position based thereon.

5. The system of claim 1, wherein the processor is configured to iteratively calculate the estimated portions and the predicted magnetic field strength until the difference between the values of the predicted magnetic field strength and the values of the actual magnetic field strength is less than a predetermined tolerance.

6. The system of claim 1 wherein the display provides the visual display of data based on a single determination of the values based on the difference between the values related to predicted magnetic field strength and the values related to the actual magnetic field strength.

7. The system of claim 1 wherein plurality of magnetic sensors comprise sixteen magnetic sensor assemblies, each magnetic sensor assembly comprising three orthogonally arranged sensors.

8. The system of claim 1 wherein the plurality of magnetic sensors are distributed in a rectangular array.

9. The system of claim 1 wherein the location of the plurality of magnets is characterized by a predetermined number of parameters and the plurality of magnetic sensors comprise a number of magnetic sensors at least equal to the predetermined number of parameters.

10. The system of claim 9 wherein at least a portion of the number of magnetic sensors are positioned in sensor modules with each sensor module comprising three orthogonally arranged magnetic sensors.

11. The system of claim 9 wherein the number of magnetic sensors are distributed over a predetermined rectangular area.

12. The system of claim 1 for use with first and second magnets associated with an indwelling medical device, the first and second magnets having first and second axes of magnetization, respectively, with the first and second axes of magnetization having a known orientation so as not to be aligned with respect to each other, the processor further configured to calculate a rotation of the indwelling medical device based on the values of the position of the first and second magnets in the three-dimensional space.

13. The system of claim 1 for use with first and second magnets associated with an indwelling medical device, the first and second magnets having first and second axes of magnetization, respectively, with the first and second axes of magnetization having a known orientation so as not to be aligned with respect to each other, the processor further configured to calculate six degrees of freedom for the indwelling medical device based on the values of the position of the first and second magnets in the three-dimensional space.

14. The system of claim 13 wherein the processor is configured to periodically calculate six degrees of freedom for the indwelling medical device and the display provides a tracking visual display of six degrees of freedom for the indwelling medical device.

15. The system of claim 1, further comprising a housing to support the display wherein the display is a two-dimensional display with at least a portion of the display being transparent to allow the user to view the surface of the patient beneath the transparent portion.

16. The system of claim 1, further comprising a housing to support the plurality of magnetic sensors wherein the display is an external display spaced apart from the housing and electrically coupled to the processor.

17. The system of claim 1 for use with a imaging device capable of generating an image of the internal anatomy of the patient, wherein the display displays the image of the internal anatomy of the patient combined with the values related to the position of each of the plurality of magnets in the three-dimensional space.

18. A method for detecting a position of a plurality of magnets within a patient from a measurement location on the surface of the patient, the method comprising:

positioning a plurality of magnetic sensors at predetermined locations wherein the location and orientation of each of the plurality of magnetic sensors is known;

detecting a static magnetic field strength and direction due to the plurality of magnets within the patient using the plurality of magnetic sensors;

generating a set of signals as a function of the detected static magnetic field strength and direction due to the plurality of magnets;

calculating an estimated position of each of the plurality of magnets in a three-dimensional space;

calculating expected values of magnetic field strength for at least a portion of the plurality of sensors based on the estimated positions of the plurality of magnets;

calculating actual values of an actual magnetic field strength using the set of signals;

determining values of the location of each of the plurality of magnets based on the difference between the expected values and the actual values; and

displaying values of the position of each of the plurality of magnets in the three-dimensional space.

19. The method of claim 18 wherein displaying values comprises displaying values of the position of each of the plurality of magnets in the three-dimensional space on an external display located remote from the plurality of sensors.

20. The method of claim 18 wherein the estimated position is calculated using signals from selected ones of the plurality of magnetic sensors whose signals are above a predetermined threshold.

21. The method of claim 18 wherein the estimated position is calculated using a neural network, the neural network receiving at least a portion of the set of signals and generating the estimated position based thereon.

22. The method of claim 18 wherein the plurality of magnetic sensors are distributed in a rectangular array, the method further comprising maintaining the sensors in fixed relationship with respect to the patient, the steps of detecting the magnetic field strength, generating the set of signals, calculating the estimated positions, calculating expected values, calculating actual values, and determining values being performed while maintaining the sensors in fixed relationship with respect to the patient.

23. The method of claim 18 wherein the location of the plurality of magnets is characterized by a predetermined number of parameters and the plurality of magnetic sensors comprise a number of magnetic sensors at least equal to the predetermined number of parameters.

24. The method of claim 18 for use with first and second magnets associated with an indwelling medical device, the first and second magnets having first and second axes of magnetization, respectively, with the first and second axes of magnetization having a known orientation so as not to be aligned with respect to each other, the method further comprising calculating a rotation of the indwelling medical device based on the values of the position of the first and second magnets in the three-dimensional space.

25. The method of claim 18 for use with first and second magnets associated with an indwelling medical device, the first and second magnets having first and second axes of magnetization, respectively, with the first and second axes of magnetization having a known orientation so as not to be aligned with respect to each other, the method further comprising calculating six degrees of freedom for the indwelling medical device based on the values of the position of the first and second magnets in the three-dimensional space.

26. The method of claim 25 wherein the steps of detecting the magnetic field strength, generating the set of signals, calculating the estimated positions, calculating expected values, calculating actual values, and determining values are periodically performed, the method further comprising calculating six degrees of freedom for the indwelling medical device and displaying a tracking visual display of six degrees of freedom for the indwelling medical device.

27. The method of claim 18 for use with a imaging device capable of generating an image of the internal anatomy of the patient, the method further comprising displaying the image of the internal anatomy of the patient combined with values related to the position of each of the plurality of magnets in the three-dimensional space.

28. The method of claim 18, further comprising altering the estimated positions based on difference between the expected values and the actual values wherein the steps of detecting the magnetic field strength, generating the set of signals, calculating the estimated positions, calculating expected values, calculating actual values, determining values, and altering estimated positions are repeated until the difference between the expected values and the actual values is less than a predetermined threshold.