Method and apparatus for coil positioning for TMS studies

• US 7,651,459 B2
• Filed: 01/06/2004
• Issued: 01/26/2010
• Est. Priority Date: 01/06/2004
• Status: Active Grant

• Current Assignee: Neuronetics, Inc.
• Original Assignee: Neuronetics, Inc.
• Inventors: MacNeill, John A., Riehl, Mark Edward, Cameron, Allan, Flender, Gregg
• Primary Examiner(s): Marmor, II; Charles A
• Assistant Examiner(s): Hopkins; Christine D
• Application Number:
  US10/752,164
• Publication Number:
  US 20050148808A1
• Time in Patent Office: 2,212 Days
• Field of Search: 600 9- 15, 600/429, 600/415, 600/427, 600/417, 600/424, 600/411, 606/130, 128/897
• US Class Current: 600/9
• CPC Class Codes: A61B 2090/363 Use of fiducial points
• CPC Class Codes: A61B 90/14 Fixators for body parts, e.g. skull clamps; Constructional details of fixators, e.g. pins
• CPC Class Codes: A61G 15/125 Head-rests
• CPC Class Codes: A61N 2/02 using magnetic fields produced by coils, including single turn loops or electromagnets A61N2/12 takes precedence

Abstract

A device provides simple positioning of the patient'"'"'s head and simple positioning of the TMS coil relative to a coordinate system of the patient'"'"'s head once the head is positioned. The TMS coil is fixed at a treatment position in the coordinate system of the patient'"'"'s head and the position in the coordinate system is recorded for use in subsequent clinical sessions. A positioner assembly supports the weight of the TMS coil and allows the operator to freely move the TMS coil to search for the patient'"'"'s motor threshold position (MTP) and/or the treatment position (TXP). If the TXP is in registration with the MTP, once the MTP is determined, the positioner assembly requires only a single adjustment of the magnet position to locate the TXP where the coil is locked in place for the duration of the TMS therapy. By recording the positions of the different adjustable components in the respective coordinate directions of the coordinate system of the patient'"'"'s head, exact repositioning of the TMS coil for the patient during a subsequent clinical visit is made possible without use of expensive imaging equipment.

Claims

1. A device comprising:

a transcranial magnetic stimulation coil;

a headset assembly that accepts a patient'"'"'s head;

a coil positioner assembly configured to hold said headset assembly and the patient'"'"'s head at a repeatable position, provides a pivot axis through the patient'"'"'s nose for finding a position used in a treatment procedure, controls positioning of said transcranial magnetic stimulation coil within a coordinate system defined about said repeatable position to find said position used in the treatment procedure, and holds the transcranial magnetic stimulation coil at said position during the treatment procedure.

2. A device as in claim 1, further comprising an alignment strip adapted to be applied to the patient at a position in registration with an anatomical landmark of the patient, said alignment strip including at least one registration mark for aligning the patient'"'"'s head within said headset assembly.

3. A device as in claim 2, wherein said headset assembly comprises a cushion for accepting a back of the patient'"'"'s head and alignment straps that restrain the patient'"'"'s head in the nodding and left/right positions.

4. A device as in claim 3, wherein said alignment strip is aligned with the patient'"'"'s nose and adapted to be affixed to the patient'"'"'s forehead to define a mid-sagittal plane, and wherein said alignment straps comprise a crown strap that is adapted to wrap from a back of the patient'"'"'s head over a crown of the patient'"'"'s head to an alignment position on the alignment strip and a pair of lateral straps that are adapted to wrap from the back of the patient'"'"'s head around the respective sides of the patient'"'"'s head to alignment positions on the alignment strip so as to center the patient'"'"'s face in the left/right direction in the mid-sagittal plane.

5. A device as in claim 4, wherein the lateral straps each include registration marks that register the headset assembly with respect to said alignment strip.

6. A device as in claim 3, wherein said alignment straps releasably connect to said alignment strip to permit the patient to be rapidly removed from the headset assembly and the coil positioner assembly in the event of an emergency or the pausing of a treatment.

7. A device as in claim 6, wherein said headset assembly is releasably attached to said coil positioner assembly.

8. A device as in claim 1, wherein the headset assembly includes a recording label upon which coordinates of said position used in the treatment procedure with respect to said repeatable position may be recorded.

9. A device as in claim 1, further including a chair that accepts the patient and locks to said coil positioner assembly at a predetermined angle so as to fix a position of said headset assembly with respect to said coil positioner assembly and a coronal plane for the patient'"'"'s head.

10. A device as in claim 9, wherein said predetermined angle is in a range of approximately 30°

-45°

.

11. A device as in claim 1, wherein said coil positioner assembly includes a robotic alignment arm that moves said transcranial magnetic stimulation coil to the position used in the treatment procedure and supports said transcranial magnetic stimulation coil at the position used in the treatment procedure.

12. A device comprising:

a transcranial magnetic stimulation coil;

a headset assembly that accepts a patient'"'"'s head; and

a coil positioner assembly configured to hold said headset assembly and the patient'"'"'s head at a repeatable position, controls positioning of said transcranial magnetic stimulation coil within a coordinate system defined about said repeatable position, and holds the transcranial magnetic stimulation coil at a position used in a treatment procedure, wherein said coil positioner assembly includes a first adjustment mechanism that adjusts the position of said transcranial magnetic stimulation coil relative to said repeatable position in a direction parallel to a mid-sagittal plane through the patient, a second adjustment mechanism that adjusts said transcranial magnetic stimulation coil in a direction of an angle of a left superior oblique plane that includes a pivot axis through a nose of the patient, a motor threshold position in the patient'"'"'s head, and said position used in the treatment procedure with respect to said mid-sagittal plane, and a third adjustment mechanism that adjusts an anterior/posterior distance of said transcranial magnetic stimulation coil in said superior oblique plane.

13. A device as in claim 12, wherein said coil positioner assembly further comprises at least one position recording element that records a location of the position used in the treatment procedure of said transcranial magnetic stimulation coil in said coordinate system relative to said repeatable position, said location being identified by respective settings of said first, second and third adjustment mechanisms.

14. A device comprising:

a transcranial magnetic stimulation coil;

a headset assembly that accepts a patient'"'"'s head; and

a coil positioner assembly configured to hold said headset assembly and the patient'"'"'s head at a repeatable position, controls positioning of said transcranial magnetic stimulation coil within a coordinate system defined about said repeatable position, and holds the transcranial magnetic stimulation coil at a position used in a treatment procedure, wherein said coil positioner assembly includes a gimbal arrangement that supports said transcranial magnetic stimulation coil and a counterbalance for said gimbal arrangement.

15. A device as in claim 14, wherein said counterbalance comprises at least one of a counterweight, at least one constant force spring, and an adjustable force cam.

16. A device as in claim 14, wherein said gimbal arrangement includes a mechanism that adjusts a roll of the transcranial magnetic stimulation coil so that said transcranial magnetic stimulation coil may seat against the patient'"'"'s head.

17. A device comprising:

a transcranial magnetic stimulation coil;

a headset assembly that accepts a patient'"'"'s head; and

a coil positioner assembly configured to hold said headset assembly and the patient'"'"'s head at a repeatable position, controls positioning of said transcranial magnetic stimulation coil within a coordinate system defined about said repeatable position, and holds the transcranial magnetic stimulation coil at a position used in a treatment procedure, wherein said coil positioner assembly includes a ball and socket that supports said transcranial magnetic stimulation coil.

18. A coil positioner assembly comprising:

a transcranial magnetic stimulation coil;

a headrest assembly configured to hold the patient'"'"'s head at a repeatable position; and

positioning apparatus that positions said transcranial magnetic stimulation coil within a coordinate system defined about said repeatable position and holds the transcranial magnetic stimulation coil at a position used in a treatment procedure, wherein said positioning apparatus includes a first adjustment mechanism that adjusts the position of said transcranial magnetic stimulation coil relative to said repeatable position in a direction parallel to a mid-sagittal plane through the patient, a second adjustment mechanism that adjusts said transcranial magnetic stimulation coil in a direction of an angle of a left superior oblique plane that includes a pivot axis through a nose of the patient, a motor threshold position in the patient'"'"'s head, and said position used in the treatment procedure with respect to said mid-sagittal plane, and a third adjustment mechanism that adjusts an anterior/posterior distance of said transcranial magnetic stimulation coil in said superior oblique plane.

19. An assembly as in claim 18, wherein said positioning apparatus further comprises at least one position recording element that records a location of the positions used in the treatment procedure of said transcranial magnetic stimulation coil in said coordinate system relative to said repeatable position, said location being identified by respective settings of said first, second and third adjustment mechanisms.

20. An assembly as in claim 18, further including a chair that accepts the patient and locks to said headrest assembly at a predetermined angle so as to fix a position of said headset assembly with respect to said positioning apparatus and a coronal plane for the patient'"'"'s head.

21. An assembly as in claim 20, wherein said predetermined angle is in a range of approximately 30°

-45°

.

22. A coil positioner assembly comprising:

a transcranial magnetic stimulation coil;

a headrest assembly configured to fix the patient'"'"'s head at a fixed left/right position so as to define a mid-sagittal plane through the patient'"'"'s nose;

a positioning apparatus that positions said transcranial magnetic stimulation coil with respect to the mid-sagittal plane and holds the transcranial magnetic stimulation coil at a position used in a treatment procedure; and

a sighting mechanism including a registration mark configured to align a corner of the patient'"'"'s eye with the positioning apparatus to define a pivot axis through the patient'"'"'s nose for finding the position used in the treatment procedure.

27. An assembly as in claim 22, wherein said positioning apparatus includes a robotic alignment arm that moves said transcranial magnetic stimulation coil to the position used during the treatment procedure and supports said transcranial magnetic stimulation coil at the position used during the treatment procedure.

23. A coil positioner assembly comprising:

a transcranial magnetic stimulation coil;

a headrest assembly configured to hold the patient'"'"'s head at a repeatable position; and

positioning apparatus that positions said transcranial magnetic stimulation coil within a coordinate system defined about said repeatable position and holds the transcranial magnetic stimulation coil at a position used during a treatment procedure, wherein said positioning apparatus includes a gimbal arrangement that supports said transcranial magnetic stimulation coil and a counterbalance for said gimbal arrangement.

24. An assembly as in claim 23, wherein said counterbalance comprises at least one of a counterweight, at least one constant force spring, and an adjustable force cam.

25. An assembly as in claim 23, wherein said gimbal arrangement includes a mechanism that adjusts a roll of the transcranial magnetic stimulation coil so that said transcranial magnetic stimulation coil may seat against the patient'"'"'s head.

26. A coil positioner assembly comprising:

a transcranial magnetic stimulation coil;

a headrest assembly configured to hold the patient'"'"'s head at a repeatable position;

positioning apparatus that positions said transcranial magnetic stimulation coil within a coordinate system defined about said repeatable position and holds the transcranial magnetic stimulation coil at a position used in a treatment procedure, wherein said positioning apparatus includes a ball and socket that supports said transcranial magnetic stimulation coil.

28. A method for repeatably positioning a transcranial magnetic stimulation coil with respect to a patient to receive treatment, comprising the steps of:

placing the patient'"'"'s head in a headset assembly having a cushion for accepting a back of the patient'"'"'s head and alignment straps that restrain the patient'"'"'s head in the nodding and left/right directions;

applying an alignment strip with a registration mark at a position on the patient so as to align the registration mark with an anatomical landmark of the patient;

wrapping a first of said alignment straps from a back of the patient'"'"'s head over a crown of the patient'"'"'s head to an alignment position on the alignment strip;

wrapping a pair of lateral straps of said alignment straps from the back of the patient'"'"'s head around the respective sides of the patient'"'"'s head to alignment positions on the alignment strip so as to center the patient'"'"'s face in the left/right direction in a mid-sagittal plane;

defining a coordinate system about the patient'"'"'s head;

finding a position used in a treatment procedure on the patient for the transcranial magnetic stimulation coil;

recording the coordinates of the position used in the treatment procedure in said coordinate system; and

mechanically supporting the transcranial magnetic stimulation coil at the position used in the treatment procedure.

29. A method as in claim 28, wherein said alignment strip is applied to a forehead of the patient and said registration mark is aligned with the patient'"'"'s nose, said lateral straps wrapping step comprising the step of adjusting a left/right position of the patient'"'"'s head until said lateral straps have the same length at the registration mark on the alignment strap.

30. A method as in claim 28, wherein said wrapping steps comprise the step of releasably connecting said first alignment strap and said pair of lateral straps to said alignment strip to permit the patient to be rapidly removed from the headset assembly in the event of an emergency or the pausing of a treatment.

31. A method as in claim 28, wherein said mechanically supporting step comprises the step of placing the transcranial magnetic stimulation coil in a gimbal arrangement that is movable in said coordinate system.

32. A method as in claim 28, further comprising the step of placing the patient'"'"'s head at an angle with respect to the horizontal that is optimized for patient comfort, cortical excitability, and so as to reduce the weight of the patient'"'"'s head on the patient'"'"'s shoulders.

33. A method as in claim 31, wherein said mechanically supporting step comprises the additional step of adjusting a roll of the transcranial magnetic stimulation coil in said gimbal arrangement so that said transcranial magnetic stimulation coil may seat against the patient'"'"'s head.

34. A method as in claim 32, wherein said angle is in a range of approximately 30°

-45°

from the horizontal.

35. A method for repeatably positioning a transcranial magnetic stimulation coil with respect to a patient to receive treatment, comprising the steps of:

aligning a registration mark of a sighting mechanism with a corner of a patient'"'"'s eye so as to define a pivot axis through the patient'"'"'s nose;

defining a coordinate system about the patient'"'"'s head;

finding a position used in a treatment procedure on the patient with respect to the pivot axis for the transcranial magnetic stimulation coil;

recording the coordinates of the position used in the treatment procedure in said coordinate system; and

mechanically supporting the transcranial magnetic stimulation coil at the position used in the treatment procedure.

36. A method as in claim 35, wherein said coordinates recording step comprises the step of recording a position at which said registration mark of said sighting mechanism is aligned with a corner of the patient'"'"'s eye.

37. A method for repeatably positioning a transcranial magnetic stimulation coil with respect to a patient to receive treatment, comprising the steps of:

placing the patient'"'"'s head at a repeatable position;

defining a coordinate system about the repeatable position;

finding a position used in a treatment procedure by adjusting a first adjustment mechanism so as to adjust an angle of a superior oblique plane with respect to a mid-sagittal plane and adjusting a second adjustment mechanism so as to adjust an anterior/posterior distance in said superior oblique plane;

recording the coordinates of the position used in the treatment procedure in said coordinate system; and

mechanically supporting the transcranial magnetic stimulation coil at the position used during the treatment procedure.

38. A method as in claim 37, comprising the step of alternately adjusting said first and second adjustment mechanisms so as to define a grid pattern of coordinates in respective superior oblique planes at different angles to the mid-sagittal plane and different positions within each respective superior oblique plane in an anterior/posterior direction until one of said position used in the treatment procedure and an indicator of said position used in the treatment procedure is found.

39. A method as in claim 37, wherein said coordinates recording step comprises the step of recording a location of the position used in the treatment procedure of said transcranial magnetic stimulation coil in said coordinate system relative to said repeatable position as respective settings of said first and second adjustment mechanisms.

40. A method as in claim 37, wherein said steps of adjusting the first and second adjustment mechanisms and recording the coordinates of the position used in the treatment procedure include the steps of automatically moving the transcranial magnetic stimulation coil and automatically recording the position used in the treatment procedure from readings of position sensors.

41. A method as in claim 39, wherein said step of placing the patient'"'"'s head at said repeatable position comprises the step of placing the patient'"'"'s head in a disposable headset assembly, and wherein said coordinates recording step comprises the step of recording said respective settings of said first and second adjustment mechanisms on a label of said disposable headset.

42. A method for repeatably positioning a transcranial magnetic stimulation coil with respect to a patient to receive treatment, comprising the steps of:

placing the patient'"'"'s head at a repeatable position;

defining a coordinate system about the repeatable position;

finding a position used in a treatment procedure on the patient for the transcranial magnetic stimulation coil;

recording the coordinates of the position used in the treatment procedure in said coordinate system; and

mechanically supporting the transcranial magnetic stimulation coil at the position used in the treatment procedure, including applying a counterbalance to the transcranial magnetic stimulation coil so as to reduce a weight force applied against the patient by the transcranial magnetic stimulation coil during the treatment procedure.

43. A method for repeatably positioning a transcranial magnetic stimulation coil with respect to a patient to receive treatment, comprising the steps of:

fixing the patient'"'"'s head at a fixed left/right position so as to define a mid-sagittal plane through the patient'"'"'s nose;

aligning a sighting mechanism with an anatomical landmark of the patient so as to define a pivot axis through the patient'"'"'s nose; and

adjusting the transcranial magnetic stimulation coil with respect to the mid-sagittal plane and the pivot axis to find a position used in a treatment procedure.

44. A method as in claim 43, wherein said aligning step includes the step of aligning a registration mark of said sighting mechanism with a corner of the patient'"'"'s eye.

45. A method as in claim 43, comprising the step of removing the sighting mechanism once the pivot axis is defined.