Method for performing multiple registrations in a navigated procedure

• US 8,311,611 B2
• Filed: 04/24/2007
• Issued: 11/13/2012
• Est. Priority Date: 04/24/2007
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Csavoy, Andrew N., Solar, Matthew S., Waynik, Jeffrey M., Freas, Mark S.
• Primary Examiner(s): Le, Long V.
• Assistant Examiner(s): Peng, Bo J
• Application Number:
  US11/739,401
• Publication Number:
  US 20080269599A1
• Time in Patent Office: 2,030 Days
• Field of Search: None
• US Class Current: 600/417
• CPC Class Codes: A61B 2034/105 Modelling of the patient, e.g. for ligaments or bones
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2034/2055 Optical tracking systems
• CPC Class Codes: A61B 2034/256 having a database of accessory information, e.g. including context sensitive help or scientific articles
• CPC Class Codes: A61B 2090/365 augmented reality, i.e. correlating a live optical image with another image
• CPC Class Codes: A61B 2090/367 creating a 3D dataset from 2D images using position information
• CPC Class Codes: A61B 2090/3983 Reference marker arrangements for use with image guided surgery
• CPC Class Codes: A61B 2090/3995 Multi-modality markers
• 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 90/17 for soft tissue, e.g. breast-holding devices
• CPC Class Codes: A61B 90/18 Retaining sheets, e.g. immobilising masks made from a thermoplastic material
• CPC Class Codes: A61B 90/36 Image-producing devices or illumination devices not otherwise provided for

Abstract

A system can be used to navigate or guide an instrument or device into an anatomy of a patient. The navigation can occur with the use of image data acquired of the patient. The image data can be registered to the patient space for navigation. Registration can occur more than once to increase efficiency and speed of the procedure.

Claims

1. A system to register image space to physical space of a patient for a surgical navigation procedure, comprising:

a first dynamic reference frame operable to be attached relative to the patient in a first manner;

a second dynamic reference frame operable to be attached to the patient in a second manner;

a tracked device operable to be used to determine at least one fiducial point on the patient;

a processor operable to correlate the fiducial point on the patient to an image fiducial point in image data of the patient; and

a tracking system operable to track at least one of the tracked device, the first dynamic reference frame, the second dynamic reference frame, or combinations thereof;

wherein the processor registers the image space and physical space with the first dynamic reference frame attached to the patient in the first manner in a first registration with a first measurable accuracy;

wherein the processor registers the image space and physical space with the second dynamic reference frame attached to the patient in the second manner in a second registration with a second measurable accuracy;

wherein the first and second dynamic reference frames each include a tracking device configured to track real-time movement of the patient in physical space relative to the image space; and

wherein the second measurable accuracy is greater than the first measurable accuracy.

2. The system of claim 1, further comprising:

a guide device selectively fixed to the patient;

wherein the second dynamic reference frame is fixed to the guide device.

3. The system of claim 2, wherein the guide device is secured to a boney structure of the patient in a substantially invasive manner for use during a surgical procedure;

wherein the second dynamic reference frame is fixed to a selected portion of the guide device during the procedure.

4. The system of claim 1, wherein the first dynamic reference frame is fixed to a surface of the patient with a surface contact member.

5. The system of claim 1, wherein the second dynamic reference frame is directly or indirectly fixed to a boney structure portion of the patient with a bone fixation member.

6. The system of claim 1, further comprising:

at least one fiducial marker operable to be fixed to the patient and imaged with the imaging system;

wherein the tracked device is operable to be moved relative to the fiducial marker to determine a position of the fiducial marker.

7. The system of claim 1, further comprising:

an imaging system operable to obtain image data of the patient.

8. The system of claim 1, wherein the tracked device includes:

a contour determining system operable to be used to determine a contour of the patient in physical space;

wherein the contour of the patient in physical space is operable to be used as a physical fiducial point to be correlated with an image fiducial point in the image data with the processor.

9. The system of claim 8 wherein the contour determining system includes a laser emitting device operable to emit a laser beam to contact the patient and the tracked device includes a portion of the laser emitting device operable to be tracked with the tracking system.

10. The system of claim 9, wherein the laser beam is operable to penetrate soft tissue of the patient and reflect off of an underlying boney structure of the patient;

wherein the processor is operable to determine a position of the boney structure of the patient with the reflected laser beam.

11. The system of claim 8, wherein the contour determining system includes a member operable to be moved relative to the patient and the tracked device includes a portion of the contour determining system operable to be device tracked with a tracking system;

wherein a plurality of points on the patient can be determined via the contour determining system to determine a contour of the patient.

12. The system of claim 8, wherein the contour determining system includes:

a flexible member having a plurality of tracking devices associated therewith;

wherein a contour can be determined based upon a tracked position of the plurality of the tracking devices.

13. The system of claim 1, wherein the tracking system includes at least one of an optical tracking system, an electromagnetic tracking system, an acoustic tracking system, or combinations thereof.

14. The system of claim 1, further comprising:

a surgical intervention device.

15. The system of claim 14, wherein the surgical intervention device including at least one of a deep brain stimulation electrode, a micro-electrode for recording, a catheter, an ablation device, a guide cannula, a cannula, a scalpel, or combinations thereof.

16. The system of claim 1, wherein the first dynamic reference frame attached relative to the patient in the first manner is substantially noninvasive;

wherein the second dynamic reference frame attached to the patient in the second manner is invasive.

17. The system of claim 1, wherein fiducial point on the patient includes a physical fiducial point including at least one of a 2D contour, a 3D contour, a landmark, a fiducial marker, or combinations thereof.

18. The system of claim 12, wherein the flexible member is formed from a plurality of fibers, the plurality of tracking devices being associated with a corresponding plurality of fibers.

46. The system of claim 18, wherein the plurality of fibers includes a plurality of fibers woven in a parallel or perpendicular relationship to each other.

47. The system of claim 18, wherein at least one of the plurality of tracking devices associated with one of plurality of fibers is positioned orthogonally to another one of the plurality of tracking devices associated with another one of the plurality of fibers;

and

wherein each tracking device of the plurality of tracking devices includes a coil formed around a respective fiber of the corresponding plurality of fibers.

48. The system of claim 18, wherein the flexible member comprises an access flap movable from a closed position to gain access to an associated access portal in the flexible member.

19. A method to register image space to physical space of a patient for a surgical navigation procedure, comprising:

acquiring image data of the patient defining the image space and including at least one image fiducial point;

identifying the at least one image fiducial point;

attaching a first dynamic reference frame to the patient in a first manner;

performing a first registration of the image space to the physical space having a first measurable accuracy with the first dynamic reference frame attached to the patient;

attaching a second dynamic reference frame to the patient in a second manner; and

performing a second registration of the image space to the physical space having a second measurable accuracy with the second dynamic reference frame attached to the patient, the second measurable accuracy being greater than the first measurable accuracy;

wherein the first and second dynamic reference frames each include a tracking device configured to track real-time movement of the patient in physical space relative to the image space.

20. The method of claim 19, wherein attaching the first dynamic reference frame to the patient in the first manner includes contacting a surface of the patient with a contact member and associating the first dynamic reference frame with the contact member;

wherein the contact member remains substantially on the surface of the patient.

21. The method of claim 20, wherein performing the first registration includes:

determining a position of at least one physical space fiducial point and a position of the at least one image fiducial point;

correlating the at least one physical space fiducial point and the at least one image fiducial point;

wherein the first dynamic reference frame associated with the contact member is operable to provide the first measurable accuracy of the first registration.

22. The method of claim 21, further comprising:

navigating a first procedure with the first measurable accuracy.

23. The method of claim 22, further comprising:

planning a position of a burr hole in the image data;

wherein the first procedure includes forming a burr hole in a cranium of the patient at the planned position based upon the performed first registration.

24. The method of claim 22, further comprising:

navigating a second procedure based upon the second registration having the second measurable accuracy.

25. The method of claim 24, wherein navigating a second procedure includes at least one of navigating a deep brain stimulation electrode, navigating a micro-electrode, navigating a catheter, or combinations thereof.

26. The method of claim 19, wherein attaching the second dynamic reference frame to the patient in the second manner includes invasively attaching the second dynamic reference frame to the patient.

27. The method of claim 25, further comprising:

fixedly connecting an instrument guide device to the patient with a bone engaging member;

wherein invasively attaching the second dynamic reference frame includes fixedly connecting the second dynamic reference frame to the instrument guide device.

28. The method of claim 26, wherein performing the second registration includes determining at least one physical space fiducial point and correlating it to the at least one image fiducial point and registering the physical space to the image space.

29. The method of claim 27, further comprising:

navigating a procedure based upon the second registration of the image space to the physical space.

30. The method of claim 29, wherein navigating the second procedure includes at least one placing an electrode in a spinal column, placing an electrode in the brain, placing a catheter in the brain, placing a therapy delivery device in the brain, or combinations thereof.

31. The method of claim 19, further comprising:

determining at least one physical space fiducial point.

32. The method of claim 31, wherein determining the at least one physical space fiducial point includes:

interconnecting at least one fiducial marker with the patient;

acquiring an image of the at least one fiducial marker to produce the at least one image fiducial point; and

tracking an instrument with a tracking system to determine a position of the at least one fiducial marker interconnected with the patient in physical space to correlate it to the at least one image fiducial point.

33. The method of claim 19, further comprising:

positioning a flexible member relative to the patient;

associating a plurality of tracking devices with the flexible member;

determining a position of each of the plurality of the tracking devices to determine a plurality of physical fiducial points;

determining a contour of the patient based upon the determined physical fiducial points;

determining a contour in the acquired image data; and

correlating the determined contour of the image data with the determined contour of the patient to register the image space and the patient space.

34. The method of claim 31, further comprising:

producing a laser beam operable to reflect off of a soft tissue at the at least one physical fiducial point;

determining a position of a structure based upon the reflection point;

reflecting the laser beam from a plurality of the at least one physical fiducial point on the patient and determining a contour of the patient based on the plurality of physical fiducial points;

determining a contour in the acquired image data; and

correlating the determined contour of the image data with the determined contour of the patient.

35. The method of claim 33, wherein associating a plurality of tracking devices with the flexible member includes forming a coil of each of the plurality of tracking devices around a corresponding plurality of fibers forming the flexible member.

36. The method of claim 35, further comprising associating at least one of the plurality of tracking devices with one of the plurality of fibers so as to be orthogonal to another one of the plurality of tracking devices associated with another one of the plurality of fibers.

37. The method of claim 33, further comprising moving an access flap associated with the flexible member to gain access through a portal defined by the flexible member to a selected region of the patient covered by the flexible member.

38. A method to register image space to physical space of a patient for a surgical navigation procedure, comprising:

attaching at least one fiducial marker to the patient;

acquiring image data of the patient including at least one image fiducial point produced by the at least one fiducial marker;

non-invasively attaching a first dynamic reference frame to a surface of the patient in a first manner;

performing a first registration of the image data to the physical space having a first measurable accuracy with the first dynamic reference frame attached to the patient;

navigating a first procedure with the performed first registration;

invasively attaching a second dynamic reference frame to the patient in a second manner;

performing a second registration of the image data to the physical space having a second measurable accuracy with the second dynamic reference frame attached to the patient, the second measurable accuracy being greater than the first measurable accuracy; and

navigating a second procedure with the performed second registration;

wherein the first and second dynamic reference frames each include a tracking device configured to track real-time movement of the patient in physical space relative to the image space.

39. The method of claim 38, wherein non-invasively attaching the first dynamic reference frame to the patient in the first manner includes:

providing a patient contact member operable to contact the surface of the patient; and

interconnecting the first dynamic reference frame with the patient contact member.

40. The method of claim 39, further comprising:

a tensioning device operable to tension the patient contact members to a surface of the patient and operable to be quickly removed from the patient.

41. The method of claim 39, further comprising:

navigating an instrument to contact the at least one fiducial marker attached to the patient; and

determining the position of the image fiducial points in the acquired image data;

wherein performing the first registration includes correlating the tracked position of the at least one fiducial marker and the determined position of the at least one image fiducial point in the image data.

42. The method of claim 38, wherein invasively attaching the second dynamic reference frame includes attaching the second dynamic reference frame to a boney structure of the patient via a bone connecting member.

43. The method of claim 42, further comprising:

an instrument navigating device interconnected with a boney structure of the patient;

wherein non-invasively connecting the second dynamic reference frame includes interconnecting the second dynamic reference frame with the instrument navigating device.

44. The method of claim 43, wherein navigating a second procedure includes navigating the position of a lead, an electrode, navigating the position of a catheter, navigating the position of a treatment instrument, or combinations thereof into a cranium of the patient.

45. The method of claim 38, further comprising:

connecting a guide device to the patient;

wherein navigating a first procedure includes forming a burr hole in the patient;

wherein connecting the guide device includes connecting the guide device relative to the burr hole;

wherein navigating a second procedure includes positioning the guide device relative to the burr hole and moving the guide device to achieve a selected position of an instrument relative to the patient.