Cranial burr hole plug and insertion tool

Abstract

A cranial burr hole plug with an insertion tool and method of implantation is provided. The burr hole plug includes a shell; a collet interlocked within the shell; a clamp compressing the collet around an elongated medical device exiting the skull of a patient, such as a catheter or lead; and a cover over the clamp, collet, and shell. The insertion tool inserts the collet within the shell and locks the collet around the clamp. The method of implantation includes inserting the burr hole plug components in a cranial burr hole using the insertion tool and securing the exiting medical device without disturbing the position of the medical device.

1 - 20 . (canceled) 
     
     
         21 . A burr hole plug, comprising:
 a shell capable of being inserted in a burr hole of a skull;   a collet capable of securing a medical device within the shell when the collet is compressed; and   a clamp capable of interlocking with the shell and compressing the collet.   
     
     
         22 . The plug of  claim 21 , wherein the shell further comprises a body and a flange along a top opening of the shell body and wherein the body of the shell defines a side slot along the full length of the body of the shell. 
     
     
         23 . The plug of  claim 22 , wherein the body of the shell includes an exterior surface with a fixation means. 
     
     
         24 . The plug of  claim 22 , wherein the flange of the shell includes a medical device exit. 
     
     
         25 . The plug of  claim 22 , wherein the flange of the shell includes an anchor for attaching the shell to the skull. 
     
     
         26 . The plug of  claim 21 , wherein the clamp includes a side slot along the full length of the clamp. 
     
     
         27 . The plug of  claim 21 , wherein the collet includes a side slot along the full length of the collet. 
     
     
         28 . The plug of  claim 21 , further comprising a cover capable of covering the shell, collet, and clamp. 
     
     
         29 . The plug of  claim 28 , wherein the cover further comprises an anchor to attach the cover to the skull. 
     
     
         30 . The plug of  claim 28 , wherein the cover and flange of the shell are configured for being attached to each other using an anchoring arrangement, wherein the anchoring arrangement is selected from the group consisting of at least one screw and corresponding hole, at least one button that snaps into a corresponding hole, or at least one ball that friction fits into a corresponding socket. 
     
     
         31 . The plug of  claim 21 , wherein the collet includes an apex and a compressible soft cushion attached to the apex. 
     
     
         32 . The plug of  claim 21 , wherein the collet has an external conical surface, and the clamp has an internal conical surface adapted to engage with the external conical surface of the collet. 
     
     
         33 . The plug of  claim 21 , wherein the shell includes at least two interlocking slots and the clamp includes at least two externally protruding pins adapted to respectively engage with the at least two interlocking slots of the shell. 
     
     
         34 . The plug of  claim 21 , wherein the shell includes a body with a locking base and the collet includes a body with a locking base capable of interlocking with the locking base of the shell. 
     
     
         35 . The plug of  claim 21 , wherein the shell and the collet are integrated to form a shell-collet. 
     
     
         36 . The plug of  claim 21 , wherein the collet and the clamp are integrated to form a collet-clamp. 
     
     
         37 . The plug of  claim 36 , wherein the collet and the clamp are capable of being separated by rotating the clamp relative to the collet. 
     
     
         38 . The plug of  claim 21 , wherein the collet includes at least one slot capable of engaging with an insertion tool, and the clamp includes at least one hole capable of engaging with the insertion tool. 
     
     
         39 . A kit for plugging a burr hole, comprising:
 the plug of  claim 21 , the collet further including a plurality of slots, wherein the collet is capable of interlocking with the shell, the clamp further including a plurality of pins and a plurality of holes; and   a tool for assembling the burr hole plug in the burr hole, the tool comprising an internal lumen capable of receiving the collet, a plurality of ribs capable of engaging the plurality of slots on the collet to rotate the collet to cause the collet to interlock with the shell, and a plurality of pins capable of engaging the plurality of holes on the clamp to rotate the clamp to cause the plurality of pins of the clamp to engage the plurality of slots on the shell.   
     
     
         40 . A method of assembling the burr hole plug in the burr hole formed in the skull, comprising:
 inserting the medical device into the burr hole;   placing the shell and the collet into the burr hole, such that the collet surrounds the medical device; and   rotating the clamp to interlock the clamp with the shell and compress the collet, thereby securing the medical device.   
     
     
         41 . The method of  claim 40 , further comprising rotating the collet to interlock the collet to the shell. 
     
     
         42 . The method of  claim 40 , further comprising mounting the shell to the skull.