Locating an indicator

• US 8,560,042 B2
• Filed: 03/20/2012
• Issued: 10/15/2013
• 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, Mehta, Pooja, Warman, Eduardo N., Falkner, Phillip, Fleming, Ioana
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): KIMBALL, JEREMIAH T
• Application Number:
  US13/424,857
• Publication Number:
  US 20120190993A1
• Time in Patent Office: 574 Days
• Field of Search: 600/523
• 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

A system to determine and illustrate a location of position element within a volume is disclosed. The position element can be used to determine the position of a portion of an instrument. The instrument can include one or both of a cannulated member and a lead member passed through the cannula.

Claims

1. A method of determining a position of an introducer in a patient relative to a heart, comprising:

inserting a first end of the introducer into the patient, wherein the introducer has an introducer position element mounted at the first end;

fixing the introducer in the patient a distance from the heart of the patient;

passing a mapping catheter assembly into a throughbore formed through the introducer into the volume and into the heart, the mapping catheter assembly including a mapping catheter position element; and

viewing a graphical representation of a determined position of the introducer position element and the mapping catheter position element on a display, wherein the determined position of the introducer position element and the mapping catheter position element is determined by evaluating an electrical property with the introducer position element and the mapping catheter position element within the patient.

2. The method of claim 1, wherein evaluating the electrical property includes determining an impedance at the introducer position element and at the mapping catheter position element at least by sensing a voltage at the introducer position element and at the mapping catheter position element.

3. The method of claim 2, further comprising:

moving the mapping catheter beyond the first end of the introducer and into the heart of the patient;

wherein evaluating the electrical property with the mapping catheter position element includes collecting a plurality of impedance evaluations over time and generating a map based on the plurality of impedance evaluations.

4. The method of claim 3, further comprising:

viewing a fixed location of the introducer relative to the heart based on the graphical representation of the determined position;

removing the mapping catheter from the heart and the introducer;

after removing the mapping catheter, passing a lead through the throughbore of the introducer and into the heart of the patient;

placing a lead electrode into contact with a wall of the heart; and

implanting the lead electrode into the wall of the heart.

5. The method of claim 4, further comprising:

viewing map data of at least an interior of the heart and the determined location of the first end of the introducer relative to the interior of the heart based at least on the evaluating an electrical property with the introducer position element; and

prior to fixing the introducer, guiding the introducer in the volume at least by illustrating an introducer icon representing a location of the introducer relative to the map data of the heart.

6. The method of claim 5, further comprising:

viewing a location of the lead electrode as a lead icon relative to the introducer icon at the fixed location relative to the viewed map data.

7. The method of claim 6, further comprising:

guiding the lead in the volume relative to a predetermined position based on the map data and illustrated relative to the fixed location of the introducer icon.

8. The method of claim 7, further comprising:

determining a position of the introducer position element, the mapping catheter position element, and the lead only with a position sensing system, including;

providing a set of axis electrodes on an exterior surface of the patient establishing a first axis and conductive path therebetween; and

injecting a current into the patient between the set of axis electrodes and generating a voltage gradient between the set of axis electrodes;

wherein evaluating the electrical property includes sensing voltage at least one of the introducer position element, the mapping catheter position element, or the lead between the set of axis electrodes, and determining a position based on the sensed voltage along the voltage gradient between the set of axis electrodes.

9. The method of claim 8, further comprising:

providing an additional two sets of axis electrodes on the exterior surface of the patient, each set of the additional two sets of axis electrodes establishing a respective second and third axis and conductive path therebetween, each of the three axes of the three sets of axis electrodes being substantially orthogonal to each other and intersecting at a common point;

wherein injecting current into the volume includes injecting current into the volume between each of the three sets of axis electrodes and generating a voltage gradient between each of the three sets of axis electrodes;

wherein evaluating the electrical property includes sensing voltage at the position element between each of the three sets of axis electrodes to provide a determined three dimensional position of the position element.

10. A method of determining a position of an introducer in a patient relative to a heart, comprising:

inserting a first end of the introducer into the patient, wherein the introducer has an introducer position element mounted at the first end;

positioning the first end of the introducer in the patient a distance from the heart of the patient;

moving an electrode having a body cover substantially cover the electrode when the electrode is in a first retracted position through a throughbore formed through the introducer, wherein the body cover defines an electrode exit opening and a portal through the body cover, wherein the portal allows access to a conductive medium in the patient when open;

moving a portal cover to close the portal in the body cover to limit access of the conductive medium into the body cover;

evaluating an electrical property with the introducer position element and the electrode to determine a position of the first end of the introducer within the patient based on the evaluated electrical property and a position of the electrode; and

viewing a graphical representation of the determined position of the introducer position element and the electrode on a display.

11. The method of claim 10, further comprising:

implanting the electrode into the heart;

wherein moving a portal cover to close the portal in the body cover to limit access of the conductive medium into the body cover includes moving the portal cover prior to implanting the electrode into the heart.

12. The method of claim 10, further comprising:

implanting the electrode into the heart including moving the electrode from a retracted position within the body cover to an extended position exterior to the body cover and moving the electrode into a tissue of the heart.

13. The method of claim 12, wherein moving a portal cover to close the portal in the body cover occurs when moving the electrode from the first retracted position to the second extended position out the exit opening;

wherein when the electrode is in the retracted position a voltage is sensed through the portal.

14. The method of claim 13, further comprising:

passing a mapping catheter assembly through the throughbore formed through the introducer into the volume and into the heart, the mapping catheter assembly including a mapping catheter position element; and

evaluating an electrical property with the mapping catheter position element to determine a position of the mapping catheter assembly within the patient based on the evaluated electrical property.

15. The method of claim 14, further comprising:

moving the mapping catheter beyond the first end of the introducer and into the heart of the patient;

wherein evaluating the electrical property with the mapping catheter position element includes collecting a plurality of impedance evaluations over time and generating a map based on the plurality of impedance evaluations.

16. The method of claim 15, further comprising:

viewing a location of the introducer relative to the heart based on the graphical representation of the determined position relative to the generated map;

removing the mapping catheter from the heart and the introducer; and

after removing the mapping catheter, passing the electrode through the throughbore of the introducer and into the heart of the patient with the portal open to allow evaluation of the electrical property with the electrode within the body cover.

17. The method of claim 15, further comprising:

viewing map data of at least an interior of the heart and the location of the first end of the introducer relative to the interior of the heart based at least on the evaluating an electrical property with the introducer position element; and

viewing a location of the lead electrode as a lead icon relative to the introducer icon.

18. A system of determining a position of an instrument introducer in a patient relative to a heart, comprising:

an instrument introducer including a substantially rigid elongated body member having an outer wall, a first end, a second end, and a bore extending through the elongated body member between the first and second ends, the first end adapted to be inserted into a volume of the patient with the second end remaining accessible from outside of the volume;

an introducer position element affixed to an exterior surface of the outer wall and to contact a conductive medium in the volume upon insertion of the first end into the volume, the position element arranged to sense an electrical property and provide data indicative of a position of the instrument introducer;

a lead having a body cover and a lead electrode extendable from a retracted position to an extended position through an exit opening of the body cover, wherein the body cover further includes a portal positioned a distance from the exit opening that is operable to allow an electrolyte to contact the lead electrode when the lead electrode is in the retracted position, wherein the lead further includes a portal cover operably associated with the lead electrode to move to cover the portal in the body cover to substantially eliminate access to the lead electrode through the portal once the lead electrode is in the extended position through said exit opening;

a position sensing unit operable to interact with the introducer position element and the lead electrode to determine an introducer position and a lead position; and

a processor coupled to the position sensing unit, the lead electrode, the introducer position element and a display device, wherein the processor is operable to execute instructions to determine the position of at least one of the lead electrode or the introducer position element and display a graphical representation of the determined position of at least one of the instrument introducer or the lead on a display device.

19. The system of claim 18, wherein the cover is operable to move with the lead electrode when the lead electrode is moved to the extended position to cover the portal.

20. The system of claim 19, wherein the position sensing unit includes at least one set of axis generation electrodes for injecting current into the volume, the at least one set of axis generation electrodes is adapted to be positioned on an outer surface of the patient 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 axis generation electrodes;

wherein the introducer position element and the lead electrode both comprise electrodes arranged to sense the voltage gradient within the volume;

wherein the processor is operable to determine a position of both the introducer position element and the lead electrode based at least on the sensed voltage along the voltage gradient to determine the position of the electrode.