Method and apparatus for mapping a structure

• US 8,494,608 B2
• Filed: 04/09/2009
• Issued: 07/23/2013
• Est. Priority Date: 04/18/2008
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Markowitz, H. Toby, Karamanoglu, Mustafa, Mehta, Pooja, Fleming, Ioana, Scanlon, David, 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): Gedeon, Brian T
• Application Number:
  US12/421,364
• Publication Number:
  US 20090264738A1
• Time in Patent Office: 1,566 Days
• Field of Search: 600/374, 600/407, 600/523, 600/547, 606/41, 607/101, 607/111, 607/122
• 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 position sensing and map generating system, comprising:

a set of axis electrodes configured to inject a current into a volume;

a mapping instrument having a position element and operable to be located in the volume and sense the injected current at a plurality of locations within the volume;

a display device configured to display map data points related to each location of the plurality of locations;

a therapy instrument that is a therapy pacing lead configured to be implanted into the volume to perform a therapy; and

a position sensing unit configured to be connected to at least one of the set of axis electrodes, the mapping instrument, and the therapy instrument;

wherein the display device is configured to display a location of the therapy instrument relative to the displayed map data points.

2. The system claim 1, further comprising:

a pacing system configured to be connected to the pacing lead and implanted in the volume to pace a selected structure in the volume.

3. The system of claim 1, wherein the set of axis electrodes includes at least a first pair of axis electrodes, a second pair of axis electrodes, and a third pair of axis electrodes;

wherein the current includes a first current injected between the first pair of axis electrodes, a second current injected between the second pair of axis electrodes, a third current injected between the third pair of axis electrodes;

wherein each of the first axis, the second axis, and the third axis is substantially mutually orthogonal.

4. The system of claim 3, wherein the lead is configured to sense the first current, the second current, and the third current to be located along each of the first axis, the second axis, and the third axis.

5. The system of claim 4, wherein a graphical representation of a location of the lead within the volume along each of the first axis, the second axis, and the third axis is operable to be displayed on the display device relative to the displayed map.

6. A position sensing and map generating system, comprising:

a set of axis electrodes configured to inject a current into a volume;

a mapping instrument having a position element and operable to be located in the volume and sense the injected current at a plurality of locations within the volume;

a display device configured to display map data points related to each location of the plurality of locations;

a therapy instrument to be implanted in to the volume to perform a therapy;

a position sensing unit configured to be connected to at least one of the set of axis electrodes, the mapping instrument, and the therapy instrument;

a catheter having a wall extending along a length of the catheter and a window defined through the wall; and

a cover operable to move relative to the window between an open position and a closed position;

wherein the display device is configured to display a location of the therapy instrument relative to the displayed map data points;

wherein an electrolyte is able to pass through the window into the interior of the catheter to contact the lead within the catheter when the cover is in the open position.

7. A position sensing and map generating system, comprising:

a set of axis electrodes configured to inject a current into a volume;

a mapping instrument having a position element and operable to be located in the volume and sense the injected current at a plurality of locations within the volume;

a display device configured to display map data points related to each location of the plurality of locations;

a therapy instrument to be implanted in to the volume to perform a therapy; and

a position sensing unit configured to be connected to at least one of the set of axis electrodes, the mapping instrument, and the therapy instrument;

wherein the display device is configured to display a location of the therapy instrument relative to the displayed map data points;

wherein the display device is further configured to display an anatomical landmark relative to the map data points.

8. A position sensing and map generating system, comprising:

a set of axis electrodes configured to inject a current into a volume;

a mapping instrument having a position element and operable to be located in the volume and sense the injected current at a plurality of locations within the volume;

a display device configured to display map data points related to each location of the plurality of locations;

a therapy instrument to be implanted in to the volume to perform a therapy; and

a position sensing unit configured to be connected to at least one of the set of axis electrodes, the mapping instrument, and the therapy instrument;

wherein the display device is configured to display a location of the therapy instrument relative to the displayed map data points;

wherein the mapping instrument includes at least one of;

an inflatable portion;

at least two electrodes as the position element;

a guidewire operable to be positioned through a cannula;

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

a fixed position element; and

a flexible member having a moveable position element operable to flex due to a flow of material; and

a temperature sensor;

a position determination processor with the position sensing unit operable to determine a 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 second position element with the therapy instrument 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;

a catheter including an opening in a sidewall of the catheter operable to allow a fluid into an interior of the catheter and a catheter cover operable to selectively cover the opening in the sidewall of the catheter.

9. A method of sensing a position and generating a map, comprising:

determining a plurality of map data points with a mapping instrument having a position element and operable to be located in a volume and sense an injected current at a plurality of locations within the volume, wherein the injected current is injected by a set of axis electrodes configured to inject a current into the volume;

displaying map data points related to each location of the plurality of locations on a display device;

locating an implant position for a therapy instrument based on the displayed map data points;

displaying a location of the therapy instrument relative to the displayed map data points; and

implanting a pacing system configured to be connected to the pacing lead and implanted in the volume to pace a selected structure in the volume.

10. The method of claim 9, wherein determining the plurality of map data points and determining the location of the therapy instrument to be implanted into the volume to perform a therapy is performed with a position sensing unit.

11. The method of claim 10, further comprising:

connecting the position sensing unit to at least one of the set of axis electrodes, the mapping instrument, and the therapy instrument.

12. The method of claim 10, further comprising:

connecting the therapy instrument to the position sensing unit;

wherein the therapy device is a lead configured to be implanted into the volume.

13. The method of claim 12, further comprising:

configuring the lead for implantation.

14. The method of claim 13, further comprising:

determining a location for implantation of the lead at least with the displayed map.

15. A method of sensing a position and generating a map, comprising:

determining a plurality of map data points with a mapping instrument having a position element and operable to be located in a volume and sense an injected current at a plurality of locations within the volume, wherein the injected current is injected by a set of axis electrodes configured to inject a current into the volume;

displaying map data points related to each location of the plurality of locations on a display device;

locating an implant position for a therapy instrument based on the displayed map data points;

displaying a location of the therapy instrument relative to the displayed map data points; and

removing the mapping instrument from the volume prior to placing the therapy instrument within the volume.

16. A method of sensing a position and generating a map, comprising:

determining a plurality of map data points with a mapping instrument having a position element and operable to be located in a volume and sense an injected current at a plurality of locations within the volume, wherein the injected current is injected by a set of axis electrodes configured to inject a current into the volume;

displaying map data points related to each location of the plurality of locations on a display device;

locating an implant position for a therapy instrument based on the displayed map data points;

displaying a location of the therapy instrument relative to the displayed map data points;

positioning a catheter into the volume;

moving the therapy instrument within the catheter in the volume; and

providing a window through the catheter to allow an electrolyte to contact the therapy instrument.

17. A method of sensing a position and generating a map, comprising:

determining a plurality of map data points with a mapping instrument having a position element and operable to be located in a volume and sense an injected current at a plurality of locations within the volume, wherein the injected current is injected by a set of axis electrodes configured to inject a current into the volume;

displaying map data points related to each location of the plurality of locations on a display device;

locating an implant position for a therapy instrument based on the displayed map data points; and

displaying a location of the therapy instrument relative to the displayed map data points;

tracking a position of a position element on the 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;

measuring a rhythmic feature of a volume;

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

selecting between a uni-polar and bi-polar collection of positions;

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

measuring a temperature within the volume at least one of the position element, the first position element, and the second position element; 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;

measuring a motion of a fluid within the volume because the fluid acts on the inflated portion;

determining a location of a measurement of temperature;

wherein the displaying the map based on locations categorized relative to the measured rhythmic feature, includes;

determining at least a first category and a second category of the rhythmic feature;

collecting a plurality of data for each one of the first category and the second category;

saving the plurality of data for each category; and

generating a first map based only on the collected plurality of data categorized in the first category and a second map based only on the collected plurality of data categorized in the second category;

collecting temperature information at least a sub-plurality of the collected locations;

displaying a representation of the temperature at the sub-plurality of locations in the generated map.

18. A position sensing and map generating system, comprising:

a set of axis electrodes including at least a first pair of axis electrodes, a second pair of axis electrodes, and a third pair of axis electrodes, wherein a first current is injected between the first pair of axis electrodes, a second current is injected between the second pair of axis electrodes, and a third current is injected between the third pair of axis electrodes, wherein each of the first axis, the second axis, and the third axis is substantially mutually orthogonal;

a mapping instrument having a position element and operable to be located in the volume based on a sensed electrical property due to the injected current at a plurality of locations within the volume;

a lead configured to be implanted into the volume to perform a therapy and operable to be located in the volume based on a sensed electrical property due to the injected current at a plurality of locations within the volume;

a position sensing unit configured to be connected to the set of axis electrodes, the mapping instrument, and the lead, wherein the position sensing unit is configured to operate injection of the first current, the second current, and the third current and receive the sensed electrical property from both the mapping instrument and the lead;

a display device configured to display map data points related to each location of the plurality of locations and a lead graphical representation at the location of the lead relative to the map data points based on the sensed electrical property; and

a pacing system configured to be connected to the lead and implanted in the volume to pace a selected structure in the volume.

19. A position sensing and map generating system, comprising:

a set of axis electrodes including at least a first pair of axis electrodes, a second pair of axis electrodes, and a third pair of axis electrodes, wherein a first current is injected between the first pair of axis electrodes, a second current is injected between the second pair of axis electrodes, and a third current is injected between the third pair of axis electrodes, wherein each of the first axis, the second axis, and the third axis is substantially mutually orthogonal;

a mapping instrument having a position element and operable to be located in the volume based on a sensed electrical property due to the injected current at a plurality of locations within the volume;

a lead configured to be implanted into the volume to perform a therapy and operable to be located in the volume based on a sensed electrical property due to the injected current at a plurality of locations within the volume;

a position sensing unit configured to be connected to the set of axis electrodes, the mapping instrument, and the lead, wherein the position sensing unit is configured to operate injection of the first current, the second current, and the third current and receive the sensed electrical property from both the mapping instrument and the lead;

a display device configured to display map data points related to each location of the plurality of locations and a lead graphical representation at the location of the lead relative to the map data points based on the sensed electrical property;

a catheter having a wall extending along a length of the catheter and a window defined through the wall; and

a cover operable to move relative to the window between an open position and a closed position;

wherein an electrolyte is able to pass through the window into the interior of the catheter to contact the lead within the catheter.