Fiducial marker and protective cap

• US 8,170,645 B2
• Filed: 06/07/2005
• Issued: 05/01/2012
• Est. Priority Date: 06/07/2004
• Status: Active Grant

• Current Assignee: Image-Guided Neurologics Inc (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Solar, Matthew S., Freas, Mark Stephen, Bridges, Thomas L., Lee, David M.
• Primary Examiner(s): Casler, Brian
• Assistant Examiner(s): HUNTLEY, DANIEL CARROLL
• Application Number:
  US11/597,270
• Publication Number:
  US 20070260140A1
• Time in Patent Office: 2,520 Days
• Field of Search: 600/426, 606/916, 606/308, 606/309, 606/302
• US Class Current: 600/426
• CPC Class Codes: A61B 2034/2055 Optical tracking systems
• CPC Class Codes: A61B 2034/2068 using pointers, e.g. pointers having reference marks for determining coordinates of body points
• CPC Class Codes: A61B 2034/207 Divots for calibration
• CPC Class Codes: A61B 2090/0801 Prevention of accidental cutting or pricking
• CPC Class Codes: A61B 2090/363 Use of fiducial points
• CPC Class Codes: A61B 2090/3916 Bone tissue
• 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 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

This document discusses, among other things, a fiducial marker kit. In one example, the kit includes a fiducial marker assembly that includes a bone screw base for receiving an imageable marker or locatable divot. A valved protective sleeve prevents debris from accumulating in a receptacle portion of the base, which may otherwise degrade the accuracy of patient registration in an image-guided surgical procedure. In one example, the valve automatically opens or closes upon insertion or removal of a screwdriver or other tool, or a shaft portion of the imageable marker or locatable divot. Various bone screw base and receptacle combinations are also discussed.

Claims

1. An assembly for an image-guided surgical procedure, the assembly comprising:

a fiducial marker;

a bone screw base, the base including a distal threaded bone screw shaft and a proximal head, the proximal head having a receptacle formed in a proximal end thereof and configured to receive at least a portion of the fiducial marker therein; and

a protective sleeve removably fitted around an outer perimeter of the proximal head of the bone screw base, the protective sleeve including a compliant valve in a proximal end thereof that automatically opens upon insertion of an object into the valve and that automatically closes upon removal of the object from within the valve, the protective sleeve having an axial length greater than an axial length of the proximal head such that the proximal end of the protective sleeve extends beyond and is spaced apart from the proximal end of the proximal head when fitted thereto, the protective sleeve covering the receptacle when the compliant valve is in a closed position.

2. The assembly of claim 1, wherein the fiducial marker is sized and shaped to be secured to the first receptacle formed in the proximal head of the bone screw base.

3. The assembly of claim 1, further comprising a locatable divot that is sized and shaped to be secured to the proximal head of the bone screw base.

4. The assembly of claim 1, wherein the sleeve comprises a sidewall extending from the proximal end to a distal end thereof, the sidewall being removably fitted around the outer perimeter of the proximal head and forming an internal passage between the valve and the proximal head of the bone screw base.

5. The assembly of claim 1, wherein the compliant valve includes a tricuspid valve.

6. The assembly of claim 1, wherein the proximal head of the bone screw base includes a radially inwardly extending recess, and wherein the sidewall of the protective sleeve includes a radially inwardly extending lip sized and shaped to engage the recess when the sleeve is removably fitted around the proximal head.

7. The assembly of claim 1, wherein the proximal head defines a slot formed through at least a portion of the receptacle and adapted to receive a driver therein.

8. A kit comprising:

a bone screw base, the base comprising a distal threaded bone screw shaft and a proximal head including a receptacle formed in a proximal end thereof; and

a protective sleeve having a sidewall extending from a proximal end to a distal end, the proximal end including a compliant tricuspid valve that automatically opens upon insertion of an object into the valve and that automatically closes upon removal of the object from within the valve, the sidewall of the protective sleeve removably fitted around an outer perimeter of the proximal head such that the proximal end of the protective sleeve is spaced apart from the proximal end of the proximal head and covers the proximal head and the receptacle when the valve is in a closed position.

9. The kit of claim 8, further comprising an imageable marker that is sized and shaped to be secured to the receptacle formed in the proximal head of the bone screw base.

10. The kit of claim 8, further comprising a locatable divot that is sized and shaped to be secured to the receptacle formed in the proximal head of the bone screw base.

11. The kit of claim 8, further comprising the sidewall of the protective sleeve having an axial length greater than an axial length of the proximal head such that the protective sleeve extends beyond the proximal end of the proximal head when fitted thereto and forms an internal passage between the proximal end of the sleeve, the sidewall and the proximal head.

12. The kit of claim 8, wherein the proximal head defines a slot formed through at least a portion of the receptacle and adapted to receive a driver therein.

13. The kit of claim 8, wherein the sidewall of the protective sleeve covers an entire axial length of the proximal head.

14. The kit of claim 8, wherein the sidewall defines a shoulder, the shoulder engaging the proximal end of the proximal head.

15. A method comprising:

removably coupling a valved sleeve around an outer perimeter of a proximal head of a bone screw base, the valved sleeve having a compliant valve formed in a proximal end thereof, the bone screw base including a distally extending threaded shaft;

passing a shaft of a tool through the compliant valve and into engagement with an internal receptacle formed in a proximal end of the proximal head;

maintaining engagement of the bone screw base with the shaft of the tool via engagement of the compliant valve with the shaft of the tool prior to affixing the bone screw base to a skull;

affixing the bone screw base to the skull via the distally extending shaft;

removing the shaft of the tool from the bone screw base and the valved sleeve, the compliant valve automatically closing after removal of the tool to cover the proximal head and the internal receptacle;

attaching an imageable marker to the proximal head of the bone screw base, including inserting a portion of the imageable marker through the compliant valve; and

replacing the imageable marker with a locatable divot, the replacing including removing the imageable marker from the proximal head and inserting the locatable divot through the compliant valve and into the proximal head.

16. The method of claim 15, in which the inserting the portion of the imageable marker through the valve automatically opens the valve by compliant expansion of the valve, and in which the removing the imageable marker includes automatically closing the valve by compliant relaxation of the valve.

17. The method of claim 15, wherein removably coupling a valved sleeve around an outer perimeter of a proximal head of a bone screw base includes positioning a radially inwardly extending lip of the valved sleeve in a corresponding recess of the bone screw base.

18. The method of claim 15, wherein removably coupling a valved sleeve around an outer perimeter of a proximal head of a bone screw base includes removably coupling the valved sleeve around the outer perimeter of the bone screw base such that the proximal end of the valved sleeve is spaced apart from the proximal head and the valved sleeve forms an internal passage between the complaint valve and the proximal head.