Methods and apparatus for securing a therapy delivery device within a burr hole

• US 20050182464A1
• Filed: 02/09/2005
• Published: 08/18/2005
• 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.
• Granted Patent: US 7,604,644 B2
• Time in Patent Office: Days
• US Class Current: 607/115
• 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; and

a stabilizer positionable within the central opening, the stabilizer comprising a peripheral edge and opposing first and second inner surfaces that define a slot, the first inner surface comprising a 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 in the first position, the first and second inner surfaces may engage the therapy delivery device with interference at substantially any location along a length of the slot.

2. The apparatus of claim 1, wherein the stabilizer further comprises a stop member operable to limit the 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, 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.

4. The apparatus of claim 1, wherein the peripheral portion of the base further comprises a flange portion operable to seat against a cranial surface.

5. The apparatus of claim 4, further comprising fasteners to secure the flange portion to the cranial surface.

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

7. The apparatus of claim 6, wherein the engagement portion comprises protrusions.

8. The apparatus of claim 4, 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.

9. The apparatus of claim 8, wherein a width of the channel is equal to or less than an undeflected external dimension of the therapy delivery device.

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

11. The apparatus of claim 8, wherein the channel is non-linear.

12. The apparatus of claim 11, wherein the channel comprises two or more intersecting linear segments.

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

14. The apparatus of claim 8, wherein the channel forms a slot extending downwardly through a lower surface of the flange portion.

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

16. The apparatus of claim 15, wherein the cap member comprises protrusions operable to engage corresponding openings in the base.

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

18. The apparatus of claim 17, wherein the tool interface surfaces comprise protrusions extending from an upper surface of the stabilizer.

19. The apparatus of claim 18, wherein the protrusions are proximate the first and second inner surfaces.

20. The apparatus of claim 17, wherein the tool interface surfaces comprise surfaces defined by openings formed in the stabilizer.

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

22. The apparatus of claim 21, wherein the coating comprises a material selected from the group consisting of silicone, polyurethane, polyethylene, and polyacrylate.

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

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

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

26. The apparatus of claim 25, wherein the maximum height of the peripheral portion is about 3 millimeters or less.

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

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

29. The apparatus of claim 1, wherein the movable arm comprises one or more first teeth operable to engage one or more second teeth located on the stabilizer to lock the movable arm in the first position.

30. 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.

31. The apparatus of claim 30, wherein the movable arm may be locked in the second position.

32. The apparatus of claim 30, wherein the movable arm may be locked a plurality of positions between the first position and the second position.

33. A method for securing a therapy delivery device relative to a burr hole, the method comprising:

inserting the therapy delivery device through the burr hole;

positioning a base of a burr hole retention apparatus in or near the burr hole such that the therapy delivery device is located within a central opening of the base;

positioning a stabilizer in or near the central opening, whereby the therapy delivery device is routed between a first inner surface and a second inner surface of the stabilizer, wherein the first inner surface is defined by a movable arm;

repositioning the movable arm, whereby the first inner surface moves towards the second inner surface;

locking the movable arm in a first position relative to the second inner surface; and

holding the therapy delivery device with interference between the first inner surface and the second inner surface of the stabilizer at substantially any location along a length of the second inner surface.

34. The method of claim 33, wherein locking the movable arm comprises engaging first teeth associated with the movable arm with second teeth associated with the stabilizer.

35. The method of claim 33, wherein repositioning the movable arm comprises repositioning the movable arm until contact with a stop surface associated with the stabilizer prevents further movement of the movable arm.

36. The method of claim 33, wherein positioning the stabilizer in or near the central opening comprises securing the stabilizer relative to the base.

37. The method of claim 33, further comprising holding the therapy delivery device with positioning equipment while locking the movable arm in the first position.

38. The method of claim 37, wherein the positioning equipment comprises a stylet supported by stereotactic apparatus.

39. An implantable therapy delivery system, comprising:

a therapy delivery device for implantation through a burr hole;

a therapy source operable to couple to the therapy delivery device; and

an apparatus for anchoring the therapy delivery device relative to the burr hole, wherein the apparatus comprises;

a base operable to seat in or near the burr hole, the base comprising a peripheral portion at least partially surrounding a central opening; and

a stabilizer positionable within the central opening, the stabilizer comprising a peripheral edge and opposing first and second inner surfaces that define a slot, the first inner surface comprising a movable arm lockable in at least a first position corresponding to the first inner surface being substantially parallel to the second inner surface, wherein, when the movable arm is in the first position, the first and second inner surfaces may engage the therapy delivery device with interference at substantially any location along a length of the slot.

40. The system of claim 39, wherein the therapy source comprises an implantable infusion pump.