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

• US 20050182423A1
• 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 7,580,756 B2
• Time in Patent Office: Days
• US Class Current: 606/130
• 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, the first and second inner surfaces defining a slot extending through the peripheral edge of the stabilizer, wherein the first inner surface comprises a movable arm operable, when in a first position, to press the delivery device against the second inner surface at most any location along a length of the slot.

2. The apparatus of claim 1, wherein the second inner surface comprises a substantially fixed surface.

3. The apparatus of claim 1, wherein the second inner surface comprises an opposing movable arm.

4. The apparatus of claim 1, wherein the movable arm is movable 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.

5. The apparatus of claim 1, wherein the stabilizer comprises a lock portion configurable to lock the movable arm in the second position.

6. The apparatus of claim 5, wherein the lock portion comprises a tab operable to selectively engage a cantilevered end of the movable arm when the movable arm is in the second position.

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

8. The apparatus of claim 7, further comprising fasteners operable to secure the flange portion to the cranial surface.

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

10. The apparatus of claim 9, wherein the engagement portion comprises protrusions.

11. The apparatus of claim 7, wherein a channel is formed in an upper surface of the flange portion of the base, the channel extending outwardly from the central opening to a point at or near an outermost edge of the flange portion.

12. The apparatus of claim 11, wherein a width of the channel is equal to or less than an undeflected external dimension of the therapy delivery device.

13. The apparatus of claim 11, wherein the channel is operable to receive the therapy delivery device with an interference fit.

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

15. The apparatus of claim 14, wherein the channel comprises two or more intersecting linear segments.

16. The apparatus of claim 14, wherein the channel comprises a curved segment.

17. The apparatus of claim 11, wherein the channel forms a slot extending through a lower surface of the flange portion.

18. The apparatus of claim 1, wherein the apparatus further comprises a cap member operable to engage the base and cover the central opening.

19. The apparatus of claim 18, wherein the cap member comprises protrusions operable to engage corresponding openings in the base.

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

21. The apparatus of claim 20, wherein the tool interface surfaces comprise protrusions extending from an upper surface of the stabilizer.

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

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

24. The apparatus of claim 23, wherein the coating comprises a material selected from the group consisting of silicone, polyurethane, polyethylene, and polyacrylate.

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

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

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

28. The apparatus of claim 27, wherein the maximum height of the peripheral portion is about 3 millimeters or less.

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

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

31. 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, wherein the therapy delivery device is routed through a slot formed in the stabilizer by first and second inner surfaces;

repositioning a movable arm associated with the first inner surface towards the therapy delivery device; and

clamping the therapy delivery device between the movable arm and the second inner surface of the stabilizer.

32. The method of claim 31, wherein clamping the therapy delivery device comprises biasing the movable arm towards a first position.

33. The method of claim 31, wherein repositioning the movable arm comprises unlocking the movable arm from a second position.

34. The method of claim 31, wherein clamping the therapy delivery device comprises clamping the therapy delivery device at substantially any location along a length of the slot.

35. The method of claim 31, further comprising securing the stabilizer relative to the base.

36. The method of claim 31, further comprising holding the therapy delivery device with positioning equipment while clamping the therapy delivery device between the movable arm and the second inner surface.

37. The method of claim 36, wherein the positioning equipment comprises a stylet supported by stereotactic apparatus.

38. 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;

an apparatus for anchoring a 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, the first and second inner surfaces defining a slot extending through the peripheral edge of the stabilizer, wherein the first inner surface comprises a movable arm operable, when in a first position, to press the delivery device against the second inner surface at most any location along a length of the slot.

39. The system of claim 38, wherein the therapy delivery device comprises a catheter.

40. The system of claim 38, wherein the therapy source comprises an implantable infusion pump.