Uni-polar and bi-polar switchable tracking system between

• US 8,831,701 B2
• Filed: 04/14/2009
• Issued: 09/09/2014
• Est. Priority Date: 04/18/2008
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Markowitz, H. Toby, Karamanoglu, Mustafa, Mehta, Pooja, Fleming, Ioana, Scanlon, David A., Kryger, Michael, Campbell-Massa, Sean, Giese, Chad, Waldhauser, Steven L., Zhang, Shangqian Peter, Jannicke, Jeff, Falkner, Phillip, Hefner, Don, Warman, Eduardo N., Steeves, James, Receveur, Rogier, Michels, Koen, Eick, Olaf, Larik, Vincent
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): KIMBALL, JEREMIAH T
• Application Number:
  US12/423,521
• Publication Number:
  US 20090264778A1
• Time in Patent Office: 1,974 Days
• Field of Search: 600/508
• US Class Current: 600/374
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2017/00053 Mapping
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00336 with a protective sleeve, e.g. retractable or slidable
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2034/105 Modelling of the patient, e.g. for ligaments or bones
• CPC Class Codes: A61B 2090/376 using X-rays, e.g. fluoroscopy
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 2090/3983 Reference marker arrangements for use with image guided surgery
• 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 5/05 Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves impedance plethysmography A61B5/0295; measuring movement of the entire body or parts thereof A61B5/11; detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof A61B5/24
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• 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 5/063 using impedance measurements
• CPC Class Codes: A61B 5/066 : Superposing sensor position on an image of the patient, e.g. obtained by ultrasound or x-ray imaging
• CPC Class Codes: A61B 5/287 : Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/304 : Switching circuits
• CPC Class Codes: A61B 5/333 : Recording apparatus specially adapted therefor
• CPC Class Codes: A61B 5/339 : Displays specially adapted therefor
• CPC Class Codes: A61B 5/742 : using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 8/06 : Measuring blood flow measuring volume flow in general G01F, e.g. G01F1/66, G01F1/72; measuring speed of fluids in general G01P5/00
• CPC Class Codes: A61B 8/4472 : Wireless probes

Abstract

An volume of a patient can be mapped with a system operable to identify a plurality of locations and save a plurality of locations of a mapping instrument. The mapping instrument can include one or more electrodes that can sense a voltage that can be correlated to a three dimensional location of the electrode at the time of the sensing or measurement. Therefore, a map of a volume can be determined based upon the sensing of the plurality of points without the use of other imaging devices. An implantable medical device can then be navigated relative to the mapping data.

Claims

1. A system to collect map data of a volume in a patient, comprising:

an instrument positionable within the volume;

a first electrode associated with the instrument;

a second electrode associated with the instrument;

an insulator operable to selectively cover at least one of the first and second electrodes;

a processor configured to analyze data from the first electrode and the second electrode to determine uni-polar sensing by one of the first electrode or the second electrode or bi-polar sensing by both of the first electrode and the second electrode; and

a switch coupled to the processor and operable to select between recording data from one or both of the first electrode and the second electrode;

wherein when recording data with both electrodes a bi-polar signal is recorded by the processor and when only recording data with one of the electrodes a uni-polar signal is recorded by the processor;

wherein the processor is operable to determine whether either or both of the first electrode or the second electrode is covered by the insulator at least based on the data from the first electrode and the second electrode.

2. The system of claim 1, wherein the instrument is positionable within a volume of a heart in the patient.

3. The system of claim 1, wherein the first electrode comprises a tip electrode and the second electrode comprises a ring electrode spaced apart from the tip electrode.

4. The system of claim 1, wherein the instrument further comprises an inflatable member positioned adjacent a distal end of the instrument, and wherein the first electrode comprises a tip electrode positioned on one side of the inflatable member at the distal end of the instrument, and the second electrode comprises a ring electrode positioned on an opposite side of the inflatable member as the tip electrode.

5. The system of claim 1, wherein the processor is operable to receive a manual input for instructing the switch to select recording data from one or both of the first and second electrodes.

6. The system of claim 1, wherein the processor is operable to instruct the switch to select recording the bi-polar signal from both electrodes in response to determining that both electrodes are positioned outside of the insulator and in the volume.

7. The system of claim 6, wherein the processor is operable to compare the recorded data from each of the first and second electrodes that comprises the bi-polar signal.

8. The system of claim 1, wherein the processor is operable to instruct the switch to select recording the uni-polar signal from one of the first and second electrodes in response to determining that one of the first and second electrodes is covered by the insulator.

9. The system of claim 8, wherein the processor is operable to instruct the switch to record the uni-polar signal from the one of the first and second electrodes that is positioned outside of the insulator and in the volume.

10. The system of claim 1, further comprising:

a position sensing unit having at least one set of axis generation electrodes for injecting current into the volume, the at least one set of electrodes adapted to be positioned on an outer surface of the volume and establish an axis via a conductive path therebetween, the injected current generating a voltage gradient in the volume between the at least one set of electrodes;

wherein the processor is coupled to the position sensing unit, and wherein the first and second electrodes are arranged to sense voltage along the voltage gradient and provide data indicative of the sensed voltage to the processor.

11. The system of claim 1, further comprising:

wherein the instrument further includes at least one of;

an inflatable portion;

a guidewire operable to be positioned through a cannula;

a plurality of the position elements along a length of the mapping instrument; and

a temperature sensor;

a position determination processor operable to determine a position of the mapping instrument;

a display device operable to display a map based at least on the determined position of the mapping instrument;

a display processor operable to augment the map on the display device, wherein the display processor is operable to at least one of;

determine a position of the position element that is positioned to sense a voltage formed in the volume;

determine a position of an input impedance reference electrode and display it on the display device relative to the map; and

determine a pseudo position of the axis electrodes on the display device relative to the map;

a physiological measuring device;

an introducer operable to be located with the position determination processor;

a reference electrode at a fixed position on a surface of the volume and a location of the reference electrode is operable to be determined with the position determination processor; and

a procedure instrument with a second position element operable to be located relative to the map;

wherein a map of a volume is displayed on the display device for visualization by a user based solely on determined positions of one or more of the position elements.

12. A method of determining when a uni-polar or a bi-polar signal is sensed in a volume of a heart, comprising:

positioning a first electrode near a second electrode in the volume of the heart;

sensing electrical activity in the volume of the heart with the first and second electrodes;

analyzing a first signal from the first electrode based on the sensed electrical activity;

analyzing a second signal from the second electrode based on the sensed electrical activity;

determining whether the first signal and the second signal are similar;

determining that one of the first electrode or the second electrode is insulated from sensing a signal when a determination is made that the first signal and the second signals are dissimilar; and

switching sensing to uni-polar sensing when the determination is that one of the first electrode or the second electrode is insulated from sensing.

13. The method of claim 12, wherein positioning the first electrode near the second electrode includes providing the first electrode near the second electrode on an instrument and positioning the instrument in the volume.

14. The method of claim 13, wherein providing the first electrode near the second electrode includes providing a tip electrode near a ring electrode on the instrument.

15. The method of claim 12, wherein sensing electrical activity includes one of sensing a voltage and measuring an impedance in the volume.

16. The method of claim 12, further comprising sensing a bi-polar signal from the first and second electrodes when a determination is made that the signals from the first and second electrodes are similar.

17. The method of claim 13, further comprising:

providing at least one set of axis generation electrodes on an exterior surface of the volume of the patient, the at least one set of electrodes arranged to establish an axis via a conductive path therebetween; and

injecting a current into the volume between the at least one set of electrodes and generating a voltage gradient in the volume between the at least one set of electrodes;

wherein sensing electrical activity in the volume includes one of sensing voltage along the voltage gradient and measuring an impedance based on the sensed voltage and the injected current.

18. The method of claim 12, further comprising:

tracking a position of a position element including at least one of the first electrode and the second electrode on a mapping instrument in the volume;

collecting positions of the position element;

determining a validity of the collected positions;

generating a map based on the collected positions;

displaying the map on a display device;

measuring a rhythmic feature of a volume;

wherein tracking the position element, includes at least one of;

determining whether an interfering frequency is present during or prior to collecting the positions;

inflating a portion of the mapping instrument;

fixing a location of a first position element relative to a second position element;

moving a flexible member with a first member position element relative to a second member position element at a fixed position and measuring the position of the first member position element relative to the second member position element;

measuring a temperature within the volume; and

displaying on a display device at least one of;

a corrected map data generated by reducing distortion of a measured position of a mapping instrument by determining a scaling factor between two position elements of the mapping instrument;

a pseudo location of an axis electrode relative to the map;

a location of a reference electrode relative to the map;

a location of a feature determined by generating a filled volume and determining curvilinear portions to be displayed relative to the filled volume with the mapping instrument;

a map point determined by generating a virtual point based on a known position of a physical portion of the mapping instrument relative to a position element of the mapping instrument;

the map based on locations categorized relative to the measured rhythmic feature;

a virtual map data point determined based on a geometry of the mapping instrument relative to the position element; and

a location of an introducer through which the mapping instrument or the procedure instrument is passed.

19. A method of evaluating a signal from within a volume based on a uni-polar or a bi-polar signal, comprising:

providing at least one set of axis generation electrodes on an exterior surface of the volume, the at least one set of axis generation electrodes arranged to establish an axis via a conductive path therebetween;

injecting a current into the volume between the at least one set of electrodes and generating a voltage gradient in the volume between the at least one set of electrodes;

analyzing a first signal from a first electrode of an instrument in the volume;

analyzing a second signal from a second electrode of the instrument in the volume, wherein an insulative cover is moveable relative to at least one of the first electrode or the second electrode;

determining if one of the first electrode or the second electrode is insulated from sensing the voltage gradient in the volume based on the injected current in the volume; and

automatically switching between sensing uni-polar when only one of the first electrode or the second electrode is determined to be exposed to the voltage gradient in the volume based on the injected current and sensing bi-polar when both the first electrode and the second electrode are exposed to sense the voltage gradient in the volume based on the injected current.

20. The method of claim 19, further comprising:

executing instructions with a processor to evaluate the signals from the first electrode and the second electrode to allow for the automatic switching.

21. The method of claim 20, further comprising:

determining bi-polar sensing based on the first and second electrode sensing similar voltages.

22. The method of claim 19, further comprising:

collecting map data with only one of the first electrode and the second electrode when switched to uni-polar sensing and collecting map data with both the first electrode and the second electrode when switched to bi-polar sensing.