Ball and socket trajectory guide

• US 7,695,480 B2
• Filed: 09/25/2003
• Issued: 04/13/2010
• Est. Priority Date: 09/25/2003
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Parmer, Kari, Freas, Mark Stephen, Skakoon, James G., Solar, Matthew S., Miller, Thomas I.
• Primary Examiner(s): Ho; (Jackie) Tan-Uyen T.
• Assistant Examiner(s): TYSON, MELANIE RUANO
• Application Number:
  US10/671,913
• Publication Number:
  US 20050070920A1
• Time in Patent Office: 2,392 Days
• Field of Search: 606/129, 606/130, 606/96, 606/98, 606/166, 403/122, 600184-200
• US Class Current: 606/130
• CPC Class Codes: A61B 2017/603 with three points of contact, e.g. tripod
• CPC Class Codes: A61B 2090/062 penetration depth
• 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: Y10T 29/49826 Assembling or joining

Abstract

An alignment device and method is provided. Higher precision is achieved when fixing an orientation of an insertion axis using alignment devices shown. A symmetric clamping force is provided that reduces or eliminates unwanted displacement after the desired orientation is obtained. Another feature includes increased flexibility to use a variety of primary medical devices. Another feature includes a standoff feature that reduces tissue damage. Another feature includes an orienting fixture for image guided procedures.

Claims

1. An alignment device, comprising:

a longitudinal guide portion, having a longitudinal opening including a guide axis;

a spherical portion coupled to an end of the longitudinal guide portion;

a base unit, including;

a deformable substantially spherical socket formed of a socket member engaging the spherical portion including at least one relief opening in a portion of the spherical socket allowing deformation of the spherical socket; and

a substantially planar portion wherein the socket member of the spherical socket extends from a first side of the substantially planar portion; and

an actuating device surrounding and engaging an outer perimeter of the spherical socket, wherein the actuating device is not in direct contact with the spherical portion; and

a number of standoff features attached to the base unit, wherein the standoff features are adapted to directly contact a skull of a subject adjacent to an opening in the skull, wherein the number of standoff features attached to the base unit extend from a second side of the substantially planar portion away from the socket member to position the substantially planar portion a distance away from the skull.

2. The alignment device of claim 1, wherein the actuating device is adapted to cause substantially symmetric tightening of the spherical socket around at least a part of the spherical portion.

3. The alignment device of claim 1, wherein the actuating device includes a threaded locking ring adapted to engage a number of threads coupled to the spherical socket.

4. The alignment device of claim 1, wherein the at least one relief opening includes three relief openings substantially equally spaced about a circumference of the spherical socket;

wherein the socket member includes a plurality of socket members;

wherein one relief opening is between each of the plurality of socket members.

5. The alignment device of claim 4, wherein the relief openings are defined as a complete passage between at least two of the plurality of socket members defining at least a portion of the spherical socket of the base.

6. The alignment device of claim 1, wherein at least one standoff feature is adapted to contact the work surface along a line.

7. The alignment device of claim 1, wherein at least one standoff feature is adapted to contact the work surface along a circle.

8. The alignment device of claim 1, further including an orienting fixture attached to the longitudinal guide portion, wherein the orienting fixture is detectable using tissue imaging techniques.

9. The alignment device of claim 1, wherein at least one standoff feature includes a shelf to determine an attachment thickness in combination with a bone screw wherein the attachment thickness is less than a standoff feature thickness.

10. The alignment device of claim 1, wherein the substantially spherical socket defines less than an entire sphere.

11. The alignment device of claim 1, wherein the actuating device engages an entire perimeter of the spherical socket.

12. The alignment device of claim 1, further including:

a shelf that extends into a bore defined by each of the number of standoff features;

wherein each of the number of standoff features extend from a first standoff feature end at the substantially planar portion to a second standoff feature end;

wherein the shelf defines a surface intermediate the first standoff feature end and the second standoff feature end.

13. The alignment device of claim 1,

wherein the deformable substantially spherical socket is operable to allow the guide axis to be positioned in at least two angles relative to the base unit.

14. An alignment device, comprising:

a longitudinal guide portion, having a longitudinal opening including a guide axis;

a spherical portion coupled to an end of the longitudinal guide portion;

a base unit, having a spherical socket for engaging with the spherical portion and a substantially planar portion wherein the spherical socket extends from a first side of the substantially planar portion wherein the spherical socket includes at least two members deformably connected to the first side of the substantially planar portion;

a number of securing devices adapted to secure the base unit to a skull;

at least two relief openings in a portion of the spherical socket defined by a complete disassociation of at least two portions of the spherical socket, allowing deformation of the spherical socket, wherein the relief openings includes the complete disassociation of the at least two portions from each other above the substantially planar portion to allow each of the at least two portions to bend from the planar portion;

an actuating device coupled to the spherical socket to cause substantially symmetric tightening of the spherical socket around at least a part of the spherical portion; and

a number of standoff features attached to the base unit

that extend from a second side of the substantially planar portion such that the standoff members extend in a direction substantially away from the spherical socket;

wherein the number of standoff features are adapted for placement adjacent to an opening in a skull of a subject, and

wherein the substantially planar portion of the base unit and the spherical socket is adapted to mount a distance away from the skull where the standoff features contact the skull.

15. The alignment device of claim 14, wherein the number of standoff features attached to the base unit includes three standoff features.

16. The alignment device of claim 14, wherein the number of standoff features attached to the base unit includes a truncated cone shaped standoff feature.

17. The alignment device of claim 16, where at least one of the securing devices extends a length of the truncated cone to engage the skull.

18. The alignment device of claim 14, wherein the actuating device includes a threaded locking ring adapted to engage a number of threads coupled to the spherical socket.

19. The alignment device of claim 14, wherein the at least two relief openings include three relief openings substantially equally spaced about a circumference of the spherical socket.

20. The alignment device of claim 14, wherein the securing devices pass through at least a portion of the standoff features.

21. The alignment device of claim 14, further including:

a shelf that extends into a bore defined by each of the number of standoff features;

wherein each of the number of standoff features extend from a first standoff feature end at the substantially planar portion to a second standoff feature end;

wherein the shelf defines a surface intermediate the first standoff feature end and the second standoff feature end;

wherein a portion of the substantially planar portion extends over the bore at the first standoff feature end.

22. An alignment device, comprising:

a longitudinal guide portion, having a longitudinal opening including a guide axis;

a spherical portion coupled to an end of the longitudinal guide portion;

a base unit operable to be positioned relative to a work surface, having a deformable spherical socket mating with the spherical portion; and

an actuating device operatively connected to the spherical socket, wherein the actuating device is not in direct contact with the spherical portion;

at least two standoff features each having a standoff feature thickness attached to the base unit, wherein a substantial portion of the base unit is adapted to mount above the work surface, wherein each of the at least two standoff features define a passage through which an attaching device is operable to pass substantially freely and engage the work surface to fix the base unit to the work surface; and

a retention force providing member coupled to the base unit and operable to retain the attaching device near the passage;

wherein the guide axis extends through the base unit and between the at least two standoff features;

wherein the retention force providing member is an elastomeric band;

wherein the base defines a groove at a perimeter of the base operable to hold the elastomeric band.

23. An alignment device, comprising:

a longitudinal guide portion, having a longitudinal opening including a guide axis;

a spherical portion operably coupled to an end of the longitudinal guide portion;

a base unit, including;

a first portion having a first side and a second side and an outer perimeter, wherein the first portion defines a passage extending from the first side through the second side within the outer perimeter;

a single deformable substantially spherical socket including at least two individual members attached to and extending separately and away from the first side of the outer perimeter of the first portion for mating with the spherical portion, wherein a relief opening is defined as a complete separation between the at least two individual members extending from an outer surface of each of the individual members to an inner surface of each of the individual members and the at least two individual members are operable to deform relative to the first portion independently of one another;

an actuating device that surrounds and engages all of the individual members of the spherical socket to substantially symmetrically compress the at least two individual members of the substantially spherical socket, wherein the actuating device is not in direct contact with the spherical portion;

a plurality of standoff feature extending from the base unit, wherein the standoff features are is adapted to directly engage a work surface near an opening in the work surface;

a passage defined through each of the standoff features;

an attaching device operable to pass through each passage and engage the work surface; and

a retaining force applying member operable to hold the attaching device relative to the passage at least prior to moving the attaching device relative to the work surface.

24. The alignment device of claim 23, wherein the work surface is a skull of a subject.

25. The alignment device of claim 23, wherein the outer perimeter of the spherical socket includes an external thread and the actuating device defines an internal thread operable to engage the external thread;

wherein the actuating member is operable to move relative to the spherical socket, via interaction with the internal thread;

wherein as the actuating member moves relative to the spherical socket the at least two individual members move toward the guide axis.

26. The alignment device of claim 23, wherein the retaining force applying member includes an elastomeric band fit within a groove defined by an external perimeter of the base unit.

27. The alignment device of claim 23, wherein the plurality of standoff features each include a shelf extending into the plurality of standoff features to determine an attachment thickness in combination with the attaching device wherein the attachment thickness is less than a standoff feature thickness.

28. The alignment device of claim 23, further including:

a shelf;

a passage defined by each of the plurality of standoff features;

wherein each of the plurality of standoff features extend from a first standoff feature end to a second standoff feature end;

wherein the shelf defines a surface extending into the passage intermediate the first standoff feature end and the second standoff feature end in the passage;

wherein the attaching device engages the shelf to attach the base unit to the work surface.

29. The alignment device of claim 23, wherein each of the plurality of standoff features extend from the base unit a distance to position the base unit at least a portion of the distance from the work surface.

30. The alignment device claim 23, wherein the retaining force applying member includes a first structure that protrudes from a sidewall that defines the passage.

31. The alignment device of claim 23,

wherein the retaining force applying member is selected from a group consisting of an insert near the passage, a structure protruding into the passage, and an elastomeric band.

32. An alignment device, comprising:

a longitudinal guide portion, having a longitudinal opening including a guide axis;

a spherical portion operably coupled to an end of the longitudinal guide portion;

a base unit, including;

a first portion defining an outer perimeter;

a single deformable spherical socket including at least two fingers extending separately from the first portion for mating with the spherical portion, wherein at least two relief openings are defined as a complete separation between an outer surface and an inner surface of the at least two fingers and the at least two fingers are operable to deform relative to the first portion independently of one another;

an actuating device that surrounds and engages the entire outer perimeter of the spherical socket and operable to substantially symmetrically compress the at least two fingers of the spherical socket, wherein the actuating device is not in direct contact with the spherical portion;

a plurality of standoff features extending from the base unit, wherein the plurality of standoff features are adapted to directly engage a work surface near an opening in the work surface;

a passage defined through each of the plurality of standoff features;

an attaching device operable to pass through the passage and engage the work surface; and

a retaining force applying member operable to hold the attaching device relative to the passage at least prior to moving the attaching device relative to the work surface;

wherein the retaining force applying member includes an elastomeric band fit within a groove defined by an external perimeter of the base unit.

33. The alignment device of claim 32, further comprising:

an insert located substantially within the longitudinal opening wherein an outer diameter of the insert fits closely with the longitudinal opening, and an inner diameter is sized to fit closely with a device to be guided;

wherein the insert includes an inner diameter that is sized to fit closely with a biopsy probe.

34. An alignment device, comprising:

a longitudinal guide portion, having a longitudinal opening including a guide axis;

a spherical portion coupled to an end of the longitudinal guide portion;

a base unit, including;

a deformable substantially spherical socket engaging the spherical portion; and

a substantially planar portion wherein the deformable spherical socket extends from a first side of the substantially planar portion; and

an actuating device surrounding and engaging an outer perimeter of the spherical socket, wherein the actuating device is not in direct contact with the spherical portion;

a number of standoff features attached to the base unit, wherein the standoff features are adapted to directly contact a skull of a subject adjacent to an opening in the skull, wherein the number of standoff features attached to the base unit extend from a second side of the substantially planar portion to position the substantially planar portion a distance away from the skull; and

a retaining force applying member that is an elastomeric band across the passage and fit within a groove defined by an external perimeter of the base unit.