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

• US 6,129,668 A
• Filed: 05/08/1998
• Issued: 10/10/2000
• 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: Golden, Robert N., Haynor, David R., Somogyi, Christopher P.
• Primary Examiner(s): Lateef, Marvin M.
• Assistant Examiner(s): SHAW, SHAWNA JEANNINE
• Application Number:
  US09/075,280
• Time in Patent Office: 886 Days
• Field of Search: 600/407, 600/424, 600/408, 128/899, 324/207.13, 324/207.17, 324/247, 324/207.11, 324/260
• US Class Current: 600/424
• CPC Class Codes: A61B 2017/00876 magnetic
• 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 5/06 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 5/062 using magnetic field

Abstract

A device to detect the location of a magnet coupled to an indwelling medical device within a patient uses three or more sets of magnetic sensors each having sensor elements arranged in a known fashion. Each sensor element senses the magnetic field strength generated by the magnet and provides data indicative of the direction of the magnet in a three-dimensional space. The device uses fundamental equations for electricity and magnetism that relate measured magnetic field strength and magnetic field gradient to the location and strength of a magnetic dipole. The device uses an iterative process to determine the actual location and orientation of the magnet. An initial estimate of the location and orientation of the 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 the difference between the predicted values and the measured values, the device estimates a new location of the magnet and calculates new predicted magnetic field strength values. This iteration process continues until the predicted values match the measured values within a desired degree of tolerance. At that point, the estimated location matches the actual location within a predetermined degree of tolerance. A two-dimensional display provides an indication of the location of the magnet with respect to the housing of the detector. A depth indicator portion of the display can be used to provide a relative or absolute indication of the depth of the magnet within the patient.

Claims

1. A system for detecting a position of a magnet associated with an indwelling medical device from a measurement location on the surface of a patient, the system comprising:

a housing;

first, second, and third magnetic sensors supported by the housing, each of the magnetic sensors comprising sensor elements to detect magnetic field strength in three orthogonal directions, the first, second, and third magnetic sensors generating first, second, and third sets of signals, respectively, as a function of static magnetic field strength and direction due to the magnet;

a processor to calculate an estimated position of the magnet in a three-dimensional space and to calculate a predicted magnetic field strength for the first, second and third sensors based on the estimated position, the processor further calculating an actual magnetic field strength using the first, second, and third sets of signals and generating an error function based on a difference between the predicted magnetic field strength and the actual magnetic field strength; and

a display providing a visual display of data related to the position of the magnet in the three-dimensional space using the error function.

2. The system of claim 1, further including a neural network to generate the estimated position, the neural network receiving the first, second and third sets of signals and generating the estimated position based thereon.

3. The system of claim 2 wherein the neural network includes a learn mode and an operational mode, the neural network functioning in the learn mode to receive a plurality of the first, second and third sets of signals and generating estimated positions for each of the plurality of sets of the first, second and third sets of signals, the neural network further receiving data related to an actual position of the magnet after generating each of the estimated positions and using the plurality of sets of the first, second and third sets of signals, the estimated position data and the actual position data to create rules for generating the estimated position data while functioning in the operational mode, the neural network functioning in the operational mode to receive the first, second and third sets of signals and to generate the estimated position of the magnet based on the first, second and third sets of signals and the rules created while functioning in the learn mode.

4. The system of claim 1 wherein the magnet has a magnetic dipole moment indicative of the orientation of the magnet and the detected magnetic dipole moment is displayed on the display to indicate the magnet orientation.

5. The system of claim 1 wherein the display is supported by the housing.

6. The system of claim 5 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.

7. The system of claim 1 wherein the display is an external display spaced apart from the housing and electrically coupled to the processor.

8. The system of claim 7 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 data related to the position of the magnet.

9. The system of claim 1 wherein the processor iteratively calculates the estimated position and the predicted magnetic field strength until the error function indicates that the predicted magnetic field strength matches the actual magnetic field strength within a predetermined tolerance.

10. The system of claim 9 wherein the processor performs a first iteration based on an initial estimated position, the system further including a neural network to generate the initial estimated position, the neural network receiving the first, second and third sets of signals and generating the initial estimated position based thereon.

11. The system of claim 1 wherein the display provides the visual display of data based on a single generation of the error function.

12. The system of claim 1 wherein the first, second, and third sensors are selected from a group of magnetic sensors comprising Hall-effect sensors, flux-gate sensors, wound-core inductive sensors, magnetic field gradient sensors, squid sensors, magneto-resistive sensors, and nuclear precession sensors.

13. The system of claim 1 for use in the presence of a magnetic field of the Earth wherein the processor subtracts a first selected one of the first, second, and third sets of signals from a second selected one of the first, second, and third sets of signals different from the first selected one of the first, second, and third sets of signals to cancel the effects of the Earth'"'"'s magnetic field.

14. The system of claim 13, further including position detector to detect the position of the housing and generate position data related thereto, and a calibration processor to compensate for variations in the Earth'"'"'s magnetic field resulting from movement of the housing to a new location, the calibration processor calculating the change in position of the housing based on the position data, calculating the actual magnetic field strength at the new location, and calculating the contribution to the actual magnetic field resulting from the magnet, the calibration processor further using a difference between the actual magnetic field strength at the new location and the contribution to the actual magnetic field resulting from the magnet to compensate for the effects of the Earth'"'"'s magnetic field.

15. The system of claim 1, further including a calibration circuit to calibrate said first, second, and third magnetic sensors.

16. The system of claim 1, further including position detector to detect the position of the housing and generate position data related thereto, the system being operable to record the position of the housing at a plurality of locations selected by the user, the display providing a visual display of the selected locations combined with the data related to the position of the magnet.

17. A system for detecting a position of a magnet associated with an indwelling medical device from a measurement location on the surface of a patient, the system comprising:

a plurality of magnetic sensors, each oriented in a known direction and generating a set of signals as a function of static magnetic field strength and direction due to the magnet;

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

a position detector to determine the location of the magnetic sensors and to generate position data relating thereto;

a calibration processor to receive the position data and values related to the location of the magnet and to compensate for the effects of the Earth'"'"'s magnetic field as the location of the magnetic sensors changes with respect to the patient; and

a display providing a visual display of values related to the position of the magnet in the three-dimensional space.

18. The system of claim 17 wherein the calibration processor calculates the change in position of the magnetic sensors based on the position data, calculates the actual magnetic field strength at the new location, and calculates the contribution to the values related to the actual magnetic field resulting from the magnet, the calibration processor further using a difference between the values related to the actual magnetic field strength at the new location and the contribution to the values related to the actual magnetic field resulting from the magnet to compensate for the effects of the Earth'"'"'s magnetic field.

19. The system of claim 17 wherein the processor iteratively calculates the estimated position and the values related to the predicted magnetic field strength until the values related to the predicted magnetic field strength matches the values related to the actual magnetic field strength within a predetermined tolerance.

20. The system of claim 19 wherein the processor performs a first iteration based on an initial estimated position, the system further including a neural network to generate the initial estimated position, the neural network receiving the first, second and third sets of signals and generating the initial estimated position based thereon.

21. The system of claim 17 wherein the processor calculates the position of the magnet based on a single calculation of the values related to the predicted magnetic field strength and the values related to the actual magnetic field strength.

22. The system of claim 17 wherein the processor calculates the estimated position using a mathematical equation representative of the magnetic field strength.

23. The system of claim 17 wherein the processor calculates the estimated position using a mathematical equation representative of a gradient of the magnetic field strength.

24. The system of claim 17 wherein the sensors are selected from a group of magnetic sensors comprising Hall-effect sensors, flux-gate sensors, wound-core inductive sensors, magnetic field gradient sensors, squid sensors, magneto-resistive sensors, and nuclear precession sensors.

25. The system of claim 17, further including a calibration circuit to calibrate the plurality of sensors.

26. The system of claim 17 wherein the processor calculates a cost function based on the difference between the values related to the predicted magnetic field strength and the values related to the measured value related to magnetic field strength, the processor further generating a minimum value for the cost function and analyzing the minimum value for the cost function with a predetermined minimum value, and generating a signal to the user to indicate whether the minimum value is above or below the predetermined minimum value.

27. A system for detecting a position of a magnet associated with an indwelling medical device from a measurement location on the surface of a patient, the system comprising:

a plurality of magnetic sensors maintained in fixed position with respect to each other, each of the magnetic sensors being oriented in a known direction and generating signals as a function of static magnetic field strength and direction due to the magnet;

a processor to calculate an estimated position of the magnet in a three-dimensional space and to calculate a predicted magnetic field strength for at least a portion of the plurality of sensors based on the estimated position, the processor further calculating an actual magnetic field strength for the portion of sensors using signals and generating an error function based on a difference between the predicted magnetic field strength and the actual magnetic field strength; and

a display providing a visual display of data related to the position of the magnet in the three-dimensional space based on the error function.

28. The system of claim 27 wherein the plurality of magnetic sensors are oriented in three orthogonal directions, the sensors generating first, second, and third sets of signals, respectively, as a function of static magnetic field strength in the three orthogonal directions.

38. The method of claim 28 for use with a imaging device capable of generating an image of the internal anatomy of the patient, the method further including the step of the displaying the image of the internal anatomy of the patient combined with the data related to the position of the magnet.

29. A method for detecting a position of a magnet associated with an indwelling medical device from a measurement location on the surface of a patient, the method comprising the steps of:

positioning a plurality of magnetic sensors at predetermined locations with respect to the magnet;

detecting a magnetic field at each of the plurality of sensors;

generating a set of signals related to the detected magnetic field due to the magnet;

calculating an estimated position of the magnet;

calculating a predicted value related to the magnetic field for the plurality of sensors based on the estimated position;

calculating an actual value related to the magnetic field using the sets of signals;

comparing the predicted value related to the magnetic field with the actual value related to the magnetic field to determine the position of the magnet; and

displaying data related to the position of the magnet.

30. The method of claim 29, further including the step of analyzing the set of signal using a neural network to thereby generate the estimated position based on the set of signals.

31. The method of claim 29, further including the steps of recalculating the estimated position and the predicted value related to the magnetic field until the predicted value related to the magnetic field matches the actual value related to the magnetic field within a predetermined tolerance.

32. The method of claim 31 wherein a first iteration is performed based on an initial estimated position, the method further including the step of analyzing the set of signal using a neural network to thereby generate the initial estimated position based on the set of signals.

33. The method of claim 29, further including the steps of altering the measurement location to thereby reposition the plurality of magnetic sensors and repeating the steps of detecting the magnetic field, generating a set of signals, calculating an estimated position, calculating a predicted value, calculating an actual value, comparing the predicted value with the actual value to determine the position of the magnet relative to the altered measurement location, and displaying data related to the position of the magnet relative to the altered measurement location.

34. The method of claim 29 wherein the plurality of sensors are selected from a group of magnetic sensors comprising Hall-effect sensors, flux-gate sensors, wound-core inductive sensors, magnetic field gradient sensors, squid sensors, magneto-resistive sensors, and nuclear precession sensors.

35. The method of claim 29 for use in the presence of a magnetic field of the Earth, the method further including the step of subtracting a selected one of the set of signals generated by a first of the plurality of magnetic sensors from a second selected one of the set of signals generated by a second of the plurality of magnetic sensors to cancel the effects of the Earth'"'"'s magnetic field.

36. The method of claim 29, further including the steps of:

detecting the position of the plurality of magnetic sensors resulting from movement of the plurality of magnetic sensors to a new location and generating position data related thereto;

calculating the change in position of the plurality of magnetic sensors based on the position data;

calculating values related to the actual magnetic field strength at the new location;

calculating the contribution to values related to the actual magnetic field resulting from the magnet; and

using a difference between the values related to actual magnetic field strength at the new location and the contribution to the actual magnetic field resulting from the magnet to compensate for the effects of the Earth'"'"'s magnetic field resulting from movement of the plurality of magnetic sensors to the new location.

37. The method of claim 29 wherein the step of displaying uses an external display spaced apart from the magnetic sensors.

39. The method of claim 29, further including the steps of:

detecting the position the magnetic sensors and generating position data related thereto;

recording the positions of the magnetic sensors at a plurality of locations selected by the user; and

displaying a visual display of the selected locations combined with the data related to the position of the magnet.