Device for immobilizing a primary instrument and method therefor

• US 8,845,656 B2
• Filed: 10/07/2010
• Issued: 09/30/2014
• Est. Priority Date: 04/07/2000
• Status: Expired due to Term

• Current Assignee: Mayo Foundation For Medical Education And Research (Mayo Clinic), Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Mayo Foundation For Medical Education And Research (Mayo Clinic), Medtronic Incorporated (Medtronic Plc)
• Inventors: Skakoon, James G., Wharen, Robert, Solar, Matthew S., Parmer, Kari, Mazzocchi, Rudy A., David, John, Murdock, Frank, Hatcher, David, Miller, Thomas I., Parmer, Timothy Alan, Truwit, Charles L.
• Primary Examiner(s): Erezo, Darwin
• Assistant Examiner(s): TON, MARTIN TRUYEN
• Application Number:
  US12/899,674
• Publication Number:
  US 20110022058A1
• Time in Patent Office: 1,454 Days
• Field of Search: 606/129, 606/130, 606/108, 600/372, 600/373, 600/377, 600/378, 604/174, 604/178, 607/116
• US Class Current: 606/130
• CPC Class Codes: A61B 2017/0023 disposable
• CPC Class Codes: A61B 2017/00398 using powered actuators, e.g. stepper motors, solenoids
• CPC Class Codes: A61B 2017/00911 for fields applied by a magnetic resonance imaging system
• CPC Class Codes: A61B 2017/3407 including a base for support on the body
• CPC Class Codes: A61B 2017/3409 including needle or instrument drives
• CPC Class Codes: A61B 2017/3411 with a plurality of holes, e.g. holes in matrix arrangement
• CPC Class Codes: A61B 2017/347 Locking means, e.g. for locking instrument in cannula
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2034/2055 Optical tracking systems
• CPC Class Codes: A61B 2090/103 Cranial plugs for access to brain
• CPC Class Codes: A61B 2090/363 Use of fiducial points
• CPC Class Codes: A61B 2090/374 NMR or MRI
• CPC Class Codes: A61B 2090/3762 using computed tomography systems [CT]
• 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 90/11 with guides for needles or instruments, e.g. arcuate slides or ball joints
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/0539 Anchoring of brain electrode systems, e.g. within burr hole

Abstract

Devices and methods provide accurate targeting, placement, and/or stabilization of an electrode or other instrument(s) into the brain or other body organ, such as to treat severe tremor or other neurological disorders. Targeting is performed using any form of image-guidance, including real-time MRI, CT, or frameless surgical navigation systems.

Claims

1. A system for securing a deep brain stimulator electrode relative to a burr hole, comprising:

a base defining a central opening and adapted to be secured relative to the burr hole;

a stabilizer removably detachable relative to the central opening of the base, the stabilizer including;

a body having an outer perimeter sized and shaped to be received in the central opening of the base, the body defining a slot extending through the body and radially inward from the outer perimeter;

a clamping device moveable within the slot between an open position and a closed position, in the open position the slot is at least substantially unobstructed by the clamping device so as to allow the deep brain stimulator electrode to pass into the slot, in the closed position the clamping device extends into and substantially obstructs the slot so as to secure the electrode relative to the base;

a tool for engaging at least an aperture in the stabilizer for moving the clamping device between the open and closed positions; and

a cap removably attached to the base.

2. The system of claim 1, wherein the base is substantially ring shaped and includes an outer perimeter and an inner perimeter, the inner perimeter defining the central opening that provides access to the burr hole.

3. The system of claim 2, wherein the central opening is substantially circular.

4. The system of claim 2, wherein an upper surface of the base defines a groove extending from the central opening substantially toward the outer perimeter, the groove being sized and shaped to receive a portion of the electrode therein.

5. The system of claim 4, wherein the upper surface of the base defines a plurality of grooves extending from the central opening substantially toward the outer perimeter, the grooves each being sized and shaped to receive a portion of the electrode therein.

6. The system of claim 5, wherein the plurality of grooves includes a pair of grooves diametrically opposed to each other.

7. The system of claim 2, wherein the inner perimeter of the base includes a lip extending at least partially around the inner perimeter and sized and shaped to support the stabilizer removably received in the central opening of the base.

8. The system of claim 1, wherein an outer perimeter of the base includes a pair of opposed attachment members extending radially outward therefrom, each attachment member defining an aperture for receiving a bone screw therethrough.

9. The system of claim 8, further comprising a groove positioned in an upper surface of the base substantially midway between the attachment members, the groove extending from the central opening to the outer perimeter of the base and being sized and shaped to receive a portion of the electrode therein.

10. The system of claim 1, wherein the stabilizer is configured to be circumferentially rotatable relative to the central opening of the base to orient the slot such that the electrode is capable of being clamped at any location within the central opening.

11. The system of claim 10, wherein the outer perimeter of the body includes a pair of coupling members extending radially outward therefrom and configured to removably couple the stabilizer to the base in a desired circumferential orientation relative to the base.

12. The system of claim 1, wherein the outer perimeter of the body includes a pair of opposed coupling members configured to fix the stabilizer to the base.

13. The system of claim 1, wherein the clamping device is rotatably moveable within the slot about an axis perpendicular to a plane of the body.

14. The system of claim 1, wherein the clamping device includes a radial length at least as long as a radial length of the slot.

15. The system of claim 1, wherein an outer perimeter surface of the clamping device is used to at least partially close a perimeter opening of the slot.

16. The system of claim 1, wherein the clamping device includes a single cam member rotatably moveable relative to the slot to clamp the electrode between the single cam member and a sidewall of the slot.

17. The system of claim 1, wherein the cap includes at least two projections extending from a perimeter thereof, the projections being opposed from each other and configured to be removably received in a snap-fit manner in corresponding receptacles positioned in the base.

18. The system of claim 1, wherein the cap includes a first and a second pair of spaced apart projections extending from diametrically opposed sides of an outer perimeter of the cap, the first and second pair of projections being removably received in a corresponding first and second pair of receptacles in the base in a snap-fit manner.

19. The system of claim 18, further comprising a recess between at least one of the first and second pair of receptacles to facilitate removal of the cap.

20. The system of claim 1, wherein the cap includes a cover portion sized and shaped to at least substantially cover the central opening and a cylindrical portion extending from the cover portion, the cylindrical portion being at least partially received in the central opening and including an opening for receiving a portion of the electrode therein.

21. The system of claim 20, wherein an upper surface of the base defines a groove extending from the central opening substantially toward an outer perimeter of the base, the groove being sized and shaped to receive a portion of the electrode therein;

and

wherein the opening of the cylindrical portion is aligned with the groove of the base.

22. The system of claim 1, wherein an upper surface of the cap is substantially coplanar with an upper surface of the base when the cap is removably attached to the base.

23. The system of claim 1, wherein the clamping device locks into the substantially closed position and is opened by pressing the tool into the aperture positioned in the stabilizer.

24. The system of claim 23, wherein the aperture is positioned in the clamping device.

25. The system of claim 1, wherein the tool comprises:

a handle; and

an extension arm having a proximal end extending from the handle and a curved distal portion having a distal end configured to engage at least one of the stabilizer, base, cap, or combinations thereof.

26. The system of claim 1, further comprising a base holding and positioning device configured to be selectively coupled to the base for locating the base relative to the burr hole.

27. The system of claim 1, further comprising a guide assembly adapted to facilitate introducing and guiding the deep brain stimulator electrode relative to the burr hole and a brain of the patient.

28. The system of claim 1, further comprising the deep brain stimulator electrode.

29. A system for securing a deep brain stimulator electrode relative to a burr hole, comprising:

a substantially ring-shaped base adapted to be secured relative to the burr hole, the base including an outer perimeter and an inner perimeter defining a substantially circular central opening;

a stabilizer removably detachable relative to the central opening of the base, the stabilizer including;

a body having an outer perimeter sized and shaped to be received in the central opening of the base, the body defining a slot extending through the body and radially inward from the outer perimeter, the body defining an aperture configured for use in positioning the stabilizer relative to the base;

a clamping device rotatably moveable within the slot between an open position and a closed position, in the open position the slot is at least substantially unobstructed by the clamping device so as to allow the deep brain stimulator electrode to pass into the slot, in the closed position the clamping device extends into and substantially closes the slot so as to secure the electrode relative to the base; and

a cap removably attached to the base and sized and shaped to at least substantially cover the central opening.

30. The system of claim 29, wherein an upper surface of the base defines a groove radially extending between the inner perimeter and the outer perimeter and sized and shaped to receive a portion of the electrode therein.

31. The system of claim 29, wherein the inner perimeter of the base defines a lip extending at least partially around the inner perimeter and sized and shaped to support the stabilizer removably received in the central opening of the base;

and

wherein the stabilizer includes a pair of coupling members extending from the outer perimeter of the body, the coupling members configured to removably couple the stabilizer to the base.

32. The system of claim 29, further comprising a tool, wherein the aperture is configured to receive the tool to position the stabilizer in the central opening of the base in a desired circumferential orientation relative to the base.

33. The system of claim 29, wherein the clamping device is rotatably moveable within the slot and includes an outer perimeter surface that at least partially closes a perimeter opening of the slot.

34. The system of claim 29, wherein the clamping device includes a single cam member rotatably moveable relative to the slot to clamp the electrode between the single cam member and a sidewalk of the slot.

35. The system of claim 30, wherein the cap includes:

a first and a second pair of spaced apart projections extending from opposed sides of an outer perimeter of the cap, the first and second pair of projections being removably received in a snap-fit manner in a corresponding first and second pair of spaced apart receptacles in the base; and

a cylindrical portion extending from the perimeter and sized and shaped to be at least partially received in the central opening when the cap is removably attached to the base, the cylindrical portion including an opening for receiving a portion of the electrode, the opening being aligned with the groove of the base.

36. The system of claim 35, wherein the base further comprises a recess between at least one of the first and second pair of spaced apart receptacles configured to receive the tool to detach the cover from the base.

37. The system of claim 29, further comprising a base holding and positioning device configured to be selectively coupled to at least the central opening of the base for locating the base relative to the burr hole.

38. The system of claim 29, further comprising the deep brain stimulator electrode and a guide assembly configured to facilitate introducing and guiding the deep brain stimulator electrode relative to the burr hole and a brain of the patient.

39. A system for securing a deep brain stimulator electrode relative to a burr hole, the system comprising:

the deep brain stimulator electrode adapted to be positioned through the burr hole in a skull of a patient;

a base adapted to be secured relative to the burr hole, the base defining a central opening;

a stabilizer removably detachable relative to a central opening of the base, the stabilizer including;

a body having an outer perimeter sized and shaped to be received in the central opening of the base, the body defining a slot extending through the body and radially inward from the outer perimeter;

a clamping device rotatably moveable within the slot between an open position and a closed position, in the open position the slot is at least substantially unobstructed by the clamping device so as to allow the deep brain stimulator electrode to move relative to the clamping device and the slot, in the closed position the clamping device extends into and substantially obstructs the slot so as to secure the electrode relative to the base;

a tool for engaging at least an aperture in the stabilizer for positioning the stabilizer relative to the base; and

a cap removably attached to the base and sized and shaped to at least substantially cover the central opening.

40. The system of claim 39, further comprising:

a pair of opposed attachment members extending radially outward from an outer perimeter of the base;

a pair of bone screws configured to be received through respective apertures of the attachment members, the bone screws adapted to secure the base to the skull; and

a screwdriver configured to engage the bone screws to secure the base to the skull.

41. The system of claim 39, wherein the cap includes a first and a second pair of spaced apart projections extending from opposed sides of an outer perimeter of the cap, the first and second pair of projections being removably received in a snap-fit manner in a corresponding first and second pair of spaced apart receptacles in the base.

42. The system of claim 41, further comprising a groove between at least one of the first and second pair of spaced apart receptacles configured to receive the tool to detach the cover from the base.

43. The system of claim 39, further comprising a base holding and positioning device configured to be selectively coupled to the base for locating the base relative to the burr hole.

44. The system of claim 43, wherein the base holding and positioning device includes a pair of fastener retaining members radially extending from an outer perimeter thereof, the fastener retaining members being diametrically opposed to each other and each including an aperture sized and shaped to releasably capture bone screws therein, the base holding and positioning device coupling to at least the central opening of the base such that each fastener retaining member aligns with a respective attachment member of the base.

45. The system of claim 44, wherein each fastener retaining member is scored such that each fastener retaining member separates so as to release the bone screws when the bone screws are securely tightened to the skull of the patient.

46. The system of claim 43, wherein the base holding and positioning device includes a portion sized and shaped to expandably engage the central opening of the base.

47. The system of claim 39, further comprising a guide assembly configured to facilitate introducing and guiding the deep brain stimulator electrode relative to the burr hole and a brain of the patient.

48. The system of claim 39, wherein the clamping device includes a single cam member rotatably moveable relative to the slot to clamp the electrode between the single cam member and a sidewall of the slot.

49. A system for securing a deep brain stimulator electrode relative to a burr hole, comprising:

a substantially ring-shaped base adapted to be secured relative to the burr hole, the base including an outer perimeter, an inner perimeter defining a substantially circular central opening, a lower surface configured to engage at least a surface surrounding the burr hole, and an opposed upper surface, the upper surface defining a groove extending between the outer and inner perimeters that is sized and shaped to receive a portion of the electrode therein, the base including a pair of opposed attachment members extending radially outward therefrom, each attachment member defining an aperture adapted to receive a bone screw therethrough;

a stabilizer removably detachable relative to the central opening of the base, the stabilizer including;

a body having an outer perimeter sized and shaped to be received in the central opening of the base, the body defining a slot extending through the body and radially inward from the outer perimeter, and an aperture configured for use in positioning the stabilizer relative to the base, the body including a pair of opposed coupling members configured to removably fix the stabilizer to the base;

a clamping device moveable within the slot between an open position and a closed position, in the open position the slot is at least substantially unobstructed by the clamping device so as to allow the deep brain stimulator electrode to pass into the slot, in the closed position the clamping device extends into and substantially closes the slot so as to secure the electrode relative to the base; and

a cap including a cover portion sized and shaped to at least substantially cover the central opening and a cylindrical portion extending from the cover portion, the cylindrical portion being at least partially received in the central opening and including an opening for receiving a portion of the electrode therein, the opening being aligned with the groove in the upper surface of the base, the cap including a first and a second pair of spaced apart projections extending therefrom and configured to be removably received in a snap-fit manner in a corresponding first and second pair of spaced apart receptacles formed in the upper surface of the base.