Apparatus for securing a therapy delivery device within a burr hole

• US 7,604,644 B2
• Filed: 02/09/2005
• Issued: 10/20/2009
• Est. Priority Date: 02/13/2004
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Schulte, Gregory T., Sage, Shahn S., Otten, Lynn M., Adams, Matthew H.
• Primary Examiner(s): Woo; Julian W
• Application Number:
  US11/054,471
• Publication Number:
  US 20050182464A1
• Time in Patent Office: 1,714 Days
• Field of Search: 606/129, 606/130, 606 72- 75, 606/103, 606/108, 606/120, 606 69- 71, 606/157, 174/152.G, 174/153.G, 245/1.5, 241/32, 241/32.WL, 241/36.A, 241/15.L, 241/36.R, 604/174, 604/175, 604177-179, 251/10, 600/386
• US Class Current: 606/129
• CPC Class Codes: A61B 2017/3407 including a base for support on the body
• CPC Class Codes: A61B 2017/347 Locking means, e.g. for locking instrument in cannula
• CPC Class Codes: A61B 2017/3492 against the outside of the body
• CPC Class Codes: A61B 2090/103 Cranial plugs for access to brain
• CPC Class Codes: A61B 90/11 with guides for needles or instruments, e.g. arcuate slides or ball joints
• CPC Class Codes: A61N 1/0539 Anchoring of brain electrode systems, e.g. within burr hole

Abstract

Apparatus and methods for securing a therapy delivery device relative to a burr hole. In one embodiment, the apparatus includes a base that is securable to bone, without the use of fasteners, either before or after insertion of the therapy delivery device into the burr hole. The apparatus may further include a stabilizer that may be engaged with both the base and the therapy delivery device while the delivery device is held with positioning apparatus. The base and/or stabilizer may frictionally engage the delivery device, e.g., receive it with interference, to secure the device in two or more non-parallel directions. In some embodiments, at least the stabilizer may include a surface coating or treatment operable to enhance frictional engagement with the therapy delivery device.

Claims

1. An apparatus for anchoring a therapy delivery device relative to a burr hole, the apparatus comprising:

a base operable to seat in or near the burr hole, the base comprising a peripheral portion at least partially surrounding a central opening, the peripheral portion defining a flange portion having an outer diameter larger than the burr hole such that the flange portion is operable to rest upon a cranial surface surrounding the burr hole; and

a disk-shaped stabilizer positionable within the central opening, the stabilizer comprising a peripheral edge and opposing first and second inner surfaces that define a slot extending through the peripheral edge of the stabilizer, the first inner surface comprising a movable arm having a cantilevered end, the movable arm lockable in a first position corresponding to the first inner surface being substantially parallel to the second inner surface, wherein, when the movable arm is locked in the first position, the first and second inner surfaces are separated by a distance that is about 2% to about 50% less than an undeflected external dimension of a therapy delivery device positioned between the first and second inner surfaces such that the first and second inner surfaces engage the therapy delivery device with interference at substantially any location along a length of the slot, and wherein the movable arm comprises a ball portion operable to interlock with a socket portion of the stabilizer when the movable arm is in the first position.

2. The apparatus of claim 1, wherein the ball portion further comprises a stop member operable to limit a location of the first inner surface relative to the second inner surface when the movable arm is in the first position.

3. The apparatus of claim 1, further comprising fasteners to secure the flange portion to the cranial surface.

4. The apparatus of claim 1, wherein the base further comprises an engagement portion for seating against an inner surface of the burr hole.

5. The apparatus of claim 4, wherein the engagement portion comprises protrusions.

6. The apparatus of claim 1 wherein the flange portion comprises an upper surface having a channel formed therein, the channel extending from the central opening outwardly to a point at or near an outermost edge of the flange portion.

7. The apparatus of claim 6, wherein a width of the channel is equal to or less than the undeflected external dimension of the therapy delivery device.

8. The apparatus of claim 6, wherein the channel is operable to receive the therapy delivery device with an interference fit.

9. The apparatus of claim 6, wherein the channel is non-linear when viewed along a longitudinal axis of the central opening of the base.

10. The apparatus of claim 9, wherein the channel comprises two or more intersecting linear segments.

11. The apparatus of claim 9, wherein the channel comprises a curved segment.

12. The apparatus of claim 6, wherein the channel forms a slot extending downwardly through a lower surface of the flange portion.

13. The apparatus of claim 1, wherein the apparatus further comprises a cap member.

14. The apparatus of claim 13, wherein the cap member comprises protrusions operable to engage corresponding openings in the base.

15. The apparatus of claim 1, wherein the stabilizer comprises tool interface surfaces.

16. The apparatus of claim 15, wherein the tool interface surfaces comprise protrusions extending from an upper surface of the stabilizer.

17. The apparatus of claim 16, wherein the protrusions are proximate the first and second inner surfaces.

18. The apparatus of claim 15, wherein the tool interface surfaces comprise surfaces defined by openings formed in the stabilizer.

19. The apparatus of claim 1, wherein one or both of the base and the stabilizer comprises a coating.

20. The apparatus of claim 19, wherein the coating comprises a material selected from the group consisting of silicone, polyurethane, polyethylene, and polyacrylate.

21. The apparatus of claim 19, wherein the coating comprises vitreous or paralytic carbon.

22. The apparatus of claim 1, wherein the therapy delivery device is a catheter.

23. The apparatus of claim 1, wherein a maximum height of the peripheral portion is about 4 millimeters or less.

24. The apparatus of claim 23, wherein the maximum height of the peripheral portion is about 3 millimeters or less.

25. The apparatus of claim 1, wherein the base comprises a material selected from the group consisting of nylon, polyurethane, polycarbonate, polyamide, and polyetheretherketone.

26. The apparatus of claim 1, wherein the stabilizer comprises a material selected from the group consisting of nylon, polyurethane, polycarbonate, polyamide, and polyetheretherketone.

27. The apparatus of claim 1, wherein the movable arm may be moved to a second position, wherein a distance between the first and second inner surfaces is greater when the movable arm is in the second position than when the movable arm is in the first position.

28. An apparatus for anchoring a therapy delivery device, the apparatus comprising:

a base operable to seat in or near a burr hole, the base comprising;

a peripheral portion at least partially surrounding a central opening, the peripheral portion defining a flange portion having an outer diameter larger than the burr hole such that the flange portion is configured to rest upon a cranial surface surrounding the burr hole; and

a ring-shaped engagement portion for receipt within the burr hole when the flange portion rests upon the cranial surface; and

a disk-shaped stabilizer to seat within the central opening, the stabilizer comprising a peripheral edge and opposing first and second inner surfaces that define a radial slot extending outwardly through the peripheral edge of the stabilizer, the first inner surface comprising a movable, cantilevered arm having a free end, the arm lockable in a first position corresponding to the first inner surface being substantially parallel to, and spaced-apart from, the second inner surface, wherein, when the arm is locked in the first position, the first and second inner surfaces are positioned to frictionally engage a catheter passing orthogonally between the first and second inner surfaces at any location along a length of the slot, the first and second inner surfaces configured to frictionally engage the catheter without occluding catheter flow, and wherein the free end of the arm comprises a ball portion operable to interlock with a socket portion of the stabilizer when the arm is in the first position.

29. The apparatus of claim 28, wherein the ball portion and socket portion comprise stop members that assist in limiting travel of the ann.

30. The apparatus of claim 28, wherein the arm may be moved to a second position, wherein a distance between the first and second inner surfaces is greater when the arm is in the second position than when the arm is in the first position.

31. The apparatus of claim 28, wherein the stabilizer comprises a thin section to allow the stabilizer to flex.