Cranial sealing plug

• US 7,004,948 B1
• Filed: 01/18/2002
• Issued: 02/28/2006
• Est. Priority Date: 01/31/2001
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Advanced Bionics Corporation (Sonova Holding AG)
• Inventors: He, Tom Xiaohai, Pianca, Anne M., Mann, Carla M., Dogali, Michael
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US10/052,331
• Time in Patent Office: 1,502 Days
• Field of Search: 606/72, 606/129, 607/116, 600/378
• US Class Current: 606/129
• CPC Class Codes: A61B 17/3462 with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals expandable cannulas A61B17/3417
• CPC Class Codes: A61B 2017/3419 Sealing means between cannula and 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: A61F 2/2875 Skull or cranium A61F2/2803 and A61F2/3099 take precedence
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/0539 Anchoring of brain electrode systems, e.g. within burr hole

Abstract

Various embodiments of a burr hole plug assembly offer significant improvements for allowing lead and/or cannula access through a burr hole drilled through a patient'"'"'s skull in connection with a Deep Brain Stimulation system, and subsequent sealing of such burr hole. The various burr hole plug assemblies described: (a) accommodate various burr hole sizes and provide a secure fit in the burr hole; (b) accommodate various locations for lead positioning and adjustment; (c) allow the lead to remain in a static position when the burr hole plug assembly is placed; (d) protect the lead from fracture at the exit location of the plug; (e) remain flush with the skull to avoid skin erosion and to eliminate unsightly flange protrusion from the patients'"'"' skull; (f) adequately hold the lead in place over time; and (g) provide a selection of various types of burr hole plug assemblies and sizes for use by the implanting surgeon, thereby eliminating the need for surgeons to resort to custom plugs and plug assemblies made in the operating room specifically to fit a given patient.

Claims

1. A cranial sealing plug assembly adapted for insertion into a burr hole having a size D2 made in a patient'"'"'s skull, comprising:

a burr hole plug ring insertable into the burr hole so as to be flush with the patients skull, the plug ring having an opening through its center which allows access into the burr hole; and

a sealing member that seals the opening through the center of the plug ring;

wherein the burr hole plug ring has a diameter D1 that is slightly larger than the size D2 of the burr hole, thereby creating a compression force that prevents movement of a lead passing through the sealing member; and

wherein the compression force further stabilizes the burr hole plug assembly in the burr hole.

2. The cranial sealing plug assembly of claim 1 wherein the sealing member comprises a septum.

3. The cranial sealing plug assembly of claim 1 wherein the burr hole plug ring includes at least one segment made from a compressible biocompatible material, and at least another segment made from a noncompressible biccompatible material.

4. The cranial sealing plug assembly of claim 3 wherein the there are at least two segments made from the compressible biocompatible material, and at least three segments made from the non-compressible biocompatible material.

5. The cranial sealing plug assembly of claim 3 wherein the compressible biocompatible material compresses an elastomer selected from the group consisting of:

silicone rubber and polyurethane.

6. The cranial sealing plug assembly of claim 3 wherein the non-compressible biocompatible material is selected from the group consisting of;

epoxy, polyurethane, and titanium, and alloy/compounds of epoxy, polyurethane, and titanium.

7. The cranial sealing plug assembly of claim 1 wherein the sealing member and burr hole plug ring have a radial slit therein for accommodating a lead or cannula passing therethrough.

8. The cranial sealing plug assembly of claim 1 further including at least one O-ring insert adapter having an outer diameter adapted to snugly fit within the burr hole, and an inner diameter adapted to receive the plug assembly.

9. The cranial sealing plug assembly of claim 8 further including a plurality of O-ring insert adapters, each having a different outer diameter adapted to snugly fit within respective burr holes of varying sizes, and each having an inner diameter adapted to receive the plug assembly, whereby the plug assembly may be inserted into burr holes of varying sizes.