Lead tracking and positioning system and method

• US 9,320,571 B2
• Filed: 12/30/2009
• Issued: 04/26/2016
• Est. Priority Date: 12/30/2009
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Seeley, Dale F., Falkner, Phillip, Hegland, Michael, Hartmann, Steven L., Jacobsen, Brad
• Primary Examiner(s): Moher, Amanda Lauritzen
• Assistant Examiner(s): Akar, Serkan
• Application Number:
  US12/649,932
• Publication Number:
  US 20110160568A1
• Time in Patent Office: 2,309 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2034/2072 Reference field transducer attached to an instrument or patient
• CPC Class Codes: A61B 2090/0811 for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis

Abstract

Image data can be obtained with an imaging device. A location of the imaging device relative to a subject can be determined. A location of an instrument can be tracked relative to the subject using a tracking system. Also, the tracked location of the instrument can be illustrated relative to the image data.

Claims

1. A lead placement system for placing a lead in a subject, the lead placement system comprising:

the lead;

a stylet comprising a body, a curved portion and an angled portion, wherein

the stylet is tubular shaped,

the body extends along a first axis between a proximal end of the stylet and the curved portion,

the angled portion extends along a second axis from the curved portion to a distal end of the stylet, and

the second axis is at a fixed predetermined angle relative to the first axis;

a first tracking device disposed within the angled portion;

a second tracking device disposed (i) within the stylet, (ii) within or proximal the curved portion, and (iii) proximal to the first tracking device,

wherein the stylet is configured to be inserted in and extend along at least a portion of the lead; and

a plurality of electrodes (i) configured to supply an electrical current to the subject to stimulate the subject, and (ii) disposed on the lead and surrounding portions of at least one of the angled portion, the curved portion and the body,

wherein

the lead has an inner diameter and an outer diameter,

each of the plurality of electrodes has an inner diameter and an outer diameter, and

at least one of (i) the inner diameter of each of the plurality of electrodes is equal to the inner diameter of the lead, or (ii) the outer diameter of each of the plurality of electrodes is equal to the outer diameter of the lead.

2. The lead placement system of claim 1, further comprising a third tracking device disposed within the body and proximal to the second tracking device,

wherein the second tracking device and the third tracking device are configured to define the first axis relative to the second axis.

3. The lead placement system of claim 2, further comprising:

the lead; and

an electrode,

wherein at least a portion of the third tracking device is disposed within a volume surrounded by the electrode when the stylet is within the lead.

4. The lead placement system of claim 3, further comprising at least one processor comprising hardware configured to:

track locations of the first tracking device, the second tracking device, and the third tracking device; and

based on the locations, determine a direction of the angled portion relative to the body.

5. The lead placement system of claim 4, further comprising a display device operable to display:

at least one icon representing at least one of the first tracking device, the second tracking device, the third tracking device, and the lead; and

a second icon representing the orientation of the angled portion relative to the body.

6. The lead placement system of claim 2, wherein:

the first tracking device, the second tracking device, and the third tracking device are at predetermined fixed positions within the stylet;

the stylet has an inner diameter; and

the first tracking device, the second tracking device, and the third tracking device are all disposed within the stylet.

7. The lead placement system of claim 6, wherein the first tracking device, the second tracking device, or the third tracking device is adhered within the stylet with an adhesive.

8. The lead placement system of claim 1, further comprising:

a third tracking device disposed within the stylet and proximal to the second tracking device;

a processor comprising hardware configured to determine locations of the first tracking device, the second tracking device, and the third tracking device; and

a display device operable to display an image and an icon, wherein the icon represents a location of (i) at least a portion of the stylet, (ii) the lead, or (iii) the at least the portion of the stylet and the lead.

9. The lead placement system of claim 8, wherein:

the stylet includes an outer diameter;

the lead has an inner diameter; and

a clearance between the outer diameter of the stylet and the inner diameter of the lead is about 0.01 mm to about 0.02 mm.

10. The lead placement system of claim 8, wherein the predetermined angle between the first axis and the second axis is 25-35 degrees.

11. The lead placement system of claim 8, further comprising a localizer configured to generate an electromagnetic field, wherein:

each of the first tracking device, the second tracking device, and the third tracking device include a respective coil; and

the coils are operable to sense the electromagnetic field generated by the localizer.

12. The lead placement system of claim 11, wherein each of the first tracking device, the second tracking device and the third tracking device includes a respective plurality of coils.

13. The lead placement system of claim 11, wherein:

each of the first tracking device, the second tracking device, and the third tracking device includes a respective coil; and

each of the coils is formed around a respective elongated magnetic permeable core.

14. The lead placement system of claim 8, wherein the hardware of the processor is configured to, based on tracking information, determine a target location of the icon relative to the image.

15. The lead placement system of claim 1, wherein:

the plurality of electrodes include a first electrode, a second electrode, and a third electrode;

the first electrode surrounds a portion of the angled portion;

the second electrode surrounds a portion of the curved portion; and

the third electrode surrounds a portion of the body.

16. The lead placement system of claim 1, wherein:

the inner diameter of each of the plurality of electrodes is equal to the inner diameter of the lead; and

the outer diameter of each of the plurality of electrodes is equal to the outer diameter of the lead.

17. The lead placement system of claim 1, further comprising a plurality of wires connected to respective ones of the plurality of electrodes and extending (i) along and within the lead, and (ii) along and external to the stylet.

18. The lead placement system of claim 1, wherein the body and the angled portion are straight members of the stylet.

19. The lead placement system of claim 1, wherein the stylet extends from a proximal end of the lead to a distal end of the lead.

20. The lead placement system of claim 1, wherein the plurality of electrodes surround portions of the angled portion, the curved portion and the body.

21. The lead placement system of claim 1, wherein the second tracking device is disposed within the curved portion.

22. The lead placement system of claim 1, wherein the second tracking device is disposed adjacent to the curved portion.

23. The lead placement system of claim 17, wherein:

the lead comprises an internal channel;

the internal channel extends along and is external and adjacent to the stylet; and

the plurality of wires are disposed within and extend along the internal channel.

24. The lead placement system of claim 23, wherein:

the lead comprises a first internal volume and a second internal volume;

the stylet is disposed in the first internal volume;

an outer diameter of the stylet corresponds to a diameter of the first internal volume;

the plurality of wires are disposed in the second internal volume; and

the second internal volume is defined by the internal channel.

25. The lead placement system of claim 24, wherein:

a thickness of a wall of the lead varies along an inner perimeter of the lead; and

the thickness of the wall is thickest at points along the inner perimeter of the lead and adjacent to both the first internal volume and the second internal volume.

26. A method of placing a lead in a subject, the method comprising:

positioning a stylet within the lead, wherein the lead has a plurality of electrodes on the lead, wherein the lead has an inner diameter and an outer diameter, wherein each of the plurality of electrodes has an inner diameter and an outer diameter, and wherein at least one of (i) the inner diameter of the plurality of electrodes is equal to the inner diameter of the lead, or (ii) the outer diameter of the plurality of electrodes is equal to the outer diameter of the lead;

holding the stylet in a fixed relationship with the lead such that the lead moves with the stylet, wherein

the stylet comprises a body, a curved portion and an angled portion, wherein the stylet is tubular shaped,

the plurality of electrodes surround portions of at least one of the angled portion, the curved portion and the body,

the body is proximal to the curved portion and extends along a first axis between a proximal end of the stylet and the curved portion,

the angled portion is distal to the curved portion and extends along a second axis from the curved portion to a distal end of the stylet, and

the second axis is at a fixed predetermined angle relative to the first axis;

tracking a first tracking device disposed within the angled portion;

tracking a second tracking device disposed within the stylet;

displaying an icon representing a position of at least one of the stylet and the lead; and

supplying an electrical current via the plurality of electrodes to the subject to stimulate the subject.

27. The method of claim 26, further comprising:

displaying a location of one of the plurality of electrodes; and

tracking a third tracking device disposed within the stylet and proximal to the second tracking device,

wherein at least a portion of the third tracking device is located within a volume surrounded by the one of the plurality of electrodes.

28. The method of claim 26, wherein:

the stylet is configured to be moved along a path that is defined by the angled portion relative to the body; and

the angled portion is at the distal end of the stylet and interacts with the subject to direct movement of the lead and stylet within the subject.

29. The method of claim 26, further comprising adhering the first tracking device and the second tracking device within the stylet.

30. The method of claim 26, wherein the tracking of the first tracking device and the tracking of the second tracking device includes:

generating an electromagnetic field within the subject;

sensing the electromagnetic field with the first tracking device and the second tracking device; and

determining positions of the first tracking device and the second tracking device within the electromagnetic field.