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

• US 5,879,297 A
• Filed: 05/08/1997
• Issued: 03/09/1999
• 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:
  US08/852,940
• Time in Patent Office: 670 Days
• Field of Search: 600/407, 600/409, 600/431, 600/433, 600/424, 128/899
• US Class Current: 600/407
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• 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 and in the presence of a magnetic field of the Earth, the system comprising:

a housing;

first, second, and third magnetic sensors mounted in the housing, the first sensor positioned at a first distance from a magnet and generating a first set of electrical signals as a function of a first magnetic field strength and direction due to the magnet, the second sensor positioned at a second distance from the magnet and generating a second set of electrical signals as a function of a second magnetic field strength and direction due to the magnet, and the third sensor positioned at a third distance from the magnet and generating a third set of electrical signals as a function of a third 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 and to calculate a measured magnetic field strength using the first, second, and third sets of electrical signals wherein the processor generates the measured magnetic field strength by subtracting a first selected one of the first, second, and third sets of electrical signals from a second selected one of the first, second, and third sets of electrical signals different from the first selected one of the first, second, and third sets of electrical signals to cancel the effects of the Earth'"'"'s magnetic field, the processor generating an error function based on a difference between the predicted magnetic field strength and the measured magnetic field strength; and

a display providing a visual display of the three-dimensional position of the magnet using the error function.

2. 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 measured magnetic field strength within a predetermined tolerance.

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

4. The system of claim 1 wherein the processor calculates the estimated position using a mathematical equation representative of the magnetic field strength.

5. The system of claim 1 wherein the display has a two-dimensional display area indicating the position of the magnet with respect to the housing, and a depth indicator display area to indicate the distance of the magnet from the housing.

8. 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.

9. The system of claim 1 wherein the magnet has a magnetic dipole moment indicative of an orientation of the magnet and the first, second, and third sensors detect the magnetic dipole moment.

10. The system of claim 9 wherein the detected magnetic dipole moment is displayed on the display to indicate the magnet orientation.

11. The system of claim 1 wherein each of the first, second, and third sensors comprises first, second, and third sensor elements arranged in an orthogonal fashion to detect magnetic field strength in three dimensions corresponding to the first, second, and third orthogonally arranged sensor elements, respectively.

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

13. The system of claim 1 wherein the processor generates a minimum value for the error function when analyzing the difference between the predicted magnetic field strength and the measured magnetic field, the processor further analyzing the minimum value for the error 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.

6. 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 mounted in the housing, the first sensor positioned at a first distance from a magnet and generating a first set of electrical signals as a function of a first magnetic field strength and direction due to the magnet, the second sensor positioned at a second distance from the magnet and generating a second set of electrical signals as a function of a second magnetic field strength and direction due to the magnet, and the third sensor positioned at a third distance from the magnet and generating a third set of electrical signals as a function of a third 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 and to calculate a measured magnetic field strength using the first, second, and third sets of electrical signals, the processor generating an error function based on a difference between the predicted magnetic field strength and the measured magnetic field strength; and

a two-dimensional display providing a visual display of the three-dimensional position of the magnet using the error function wherein at least a portion of the display is transparent to allow the user to view the surface of the patient beneath the transparent portion.

7. The system of claim 6 wherein the display includes a first visual indicator substantially centered in the two-dimensional display area and a second visual indicator indicating the position of the magnet with respect to the housing, the first visual indicator being a cross-hairs.

14. 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 generating a set of electrical signals as a function of a magnetic field strength and direction due to a magnet;

a processor to calculate an estimated position of the magnet in a three-dimensional space and to calculate a predicted value related to the magnetic field strength for the plurality of sensors based on the estimated position and to calculate a measured value related to the magnetic field strength using the sets of electrical signals, the processor calculating the position of the magnet based on the predicted value related to magnetic field strength and the measured value related to magnetic field strength wherein the processor calculates a cost function based on a difference between the predicted value related to magnetic field strength and 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; and

a display providing a visual display of data relating to the position of the magnet.

15. The system of claim 14 wherein the processor iteratively calculates the estimated position and the predicted value related to the magnetic field strength until the predicted value related to the magnetic field strength matches the measured value related to the magnetic field strength within a predetermined tolerance.

16. The system of claim 15 wherein the processor calculates the position of the magnet based on a single calculation of the predicted value related to magnetic field strength.

17. The system of claim 14 wherein the processor calculates the estimated position using a mathematical equation representative of the magnetic field strength.

18. The system of claim 14 wherein the processor calculates the estimated position using a mathematical equation representative of a gradient of the magnetic field strength.

19. The system of claim 14 wherein each of the plurality of sensors comprises first, second and third sensor elements arranged in an orthogonal fashion to detect magnetic field strength in three dimensions corresponding to the first, second, and third orthogonally arranged sensor elements, respectively.

20. The system of claim 14 wherein the sensor elements 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.

21. The system of claim 14 wherein the display has a two-dimensional display area indicating the position of the magnet with respect to the housing, and a depth indicator display area to indicate the distance of the magnetic from the housing.

22. The system of claim 14 wherein the magnet has a magnetic dipole moment indicative of an orientation of the magnet and the sets of electrical signals generated by plurality of sensors are indicative of the magnetic dipole moment.

23. The system of claim 22 wherein the detected magnetic dipole moment is displayed on the display to indicate the magnet orientation.

24. The system of claim 14, further including a calibration circuit to calibrate said plurality of magnetic sensors.

25. A system for detecting a position of an indwelling medical device from a measurement location on the surface of a patient and in the presence of a magnetic field of the Earth, the system comprising:

a medical device suitable for insertion into the patient, the medical device having a magnet associated therewith;

a housing;

first, second, and third magnetic sensors mounted in the housing, the first sensor positioned at a first distance from the magnet and generating a first set of electrical signals as a function of a first magnetic field strength and direction due to the magnet, the second sensor positioned at a second distance from the magnet and generating a second set of electrical signals as a function of a second magnetic field strength and direction due to the magnet, and the third sensor positioned at a third distance from the magnet and generating a third set of electrical signals as a function of a third 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 and to calculate a measured magnetic field strength using the first, second, and third sets of electrical signals wherein the processor generates the measured magnetic field strength by subtracting a first selected one of the first, second, and third sets of electrical signals from a second selected one of the first, second, and third sets of electrical signals different from the first selected one of the first, second, and third sets of electrical signals to cancel the effects of the Earth'"'"'s magnetic field, the processor generating an error function based on a difference between the predicted magnetic field strength and the measured magnetic field strength; and

a display to indicate the position of the indwelling device by providing a visual display of the three-dimensional position of the associated magnet using the error function.

26. The system of claim 25 wherein the medical device is a catheter.

27. The system of claim 26 wherein the catheter is a feeding tube.

28. The system of claim 26 wherein the catheter is a vascular tube.

29. The system of claim 25 wherein the medical device is a guidewire.

30. The system of claim 25 wherein the medical device is a medical instrument.