Catheter anchor system and method

Abstract

A catheter system and method for intracranial infusion of therapeutic substances to a patient. An anchor formed of generally flexible, elastomeric material is used to mount the catheter to the outer surface of the skull of the patient. The anchor has a through hole for receiving the catheter, a channel, extending substantially from the through hole, into which a portion of the catheter may be inserted to retain the portion substantially parallel to the surface of the skull, and at least one flange for engaging the outer surface of the skull. At least one substantially rigid standoff is provided in the flange, with the standoff having an opening for receiving a fastener to fasten the anchor to the skull.

What is claimed is:  
     
         1 . A catheter system for intracranial delivery of therapeutic substances to a patient, the system comprising: 
 an elongate catheter having a lumen and at least one drug delivery orifice in fluid communication with the lumen;    an anchor formed of generally flexible, elastomeric material for mounting the catheter to the outer surface of the skull of the patient, the anchor having: 
 a through hole for receiving the catheter,  
 a channel, extending substantially from the through hole, into which a portion of the catheter may be inserted to retain the portion substantially parallel to the surface of the skull;  
 at least one flange for engaging the outer surface of the skull; and  
 at least one substantially rigid standoff mounted in the flange, the standoff having an opening for receiving a fastener to fasten the anchor to the skull.  
   
     
     
         2 . The catheter system of  claim 1  in which the at least one flange comprises two flanges extending in opposite directions from the channel, the at least one substantially rigid standoff comprising at least one standoff mounted in each flange.  
     
     
         3 . The catheter system of  claim 2  in which the channel is substantially perpendicular to the through hole.  
     
     
         4 . The catheter system of  claim 3  in which the generally flexible, elastomeric material comprises silicone.  
     
     
         5 . The catheter system of  claim 4  in which the anchor is adapted to flex and comply with adjacent tissue.  
     
     
         6 . The catheter system of  claim 5  in which the standoffs are insert molded in the flanges of the anchor.  
     
     
         7 . The catheter system of  claim 6  in which the standoffs are formed of titanium or titanium alloy.  
     
     
         8 . The catheter system of  claim 7  in which the standoffs are substantially annular and have an undercut or circumferential channel helping to retain the standoff in the flange.  
     
     
         9 . The catheter system of  claim 7  in which the anchor has a body in which the through hole and channel are formed, the body being generally elongate and coaxial with the channel, the body extending in a direction generally perpendicular to the through hole and openings of the standoffs, the flanges extending substantially in opposite directions substantially perpendicular to the body.  
     
     
         10 . The catheter system of  claim 9  further comprising an anchor clip adapted to engage the body of the anchor adjacent the through hole, the anchor clip being adapted to be fastened to the outer surface of the skull to stabilize the catheter relative to the skull.  
     
     
         11 . The catheter system of  claim 10  in which the anchor clip is generally V-shaped having two legs each having a free end and a joined end joined with the other leg, the free end of each leg having an opening for receiving a fastener to mount the anchor clip to the skull, the anchor clip having a slot adjacent the joined ends of the legs for engagement with the anchor to stabilize the anchor.  
     
     
         12 . The catheter system of  claim 11  in which the anchor clip is formed of polysulfone  
     
     
         13 . The catheter system of  claim 1  in which the catheter is formed of silicone or polyurethane.  
     
     
         14 . A combination of the catheter system of any of claims  1 - 13  with an implantable therapeutic substance infusion device, the catheter being directly or indirectly connected with the implantable therapeutic substance infusion device for infusion of therapeutic substance from the implantable therapeutic substance infusion device through the lumen and orifice(s) of the catheter.  
     
     
         15 . A method of use of the catheter system of  claim 1 , the method comprising: 
 inserting the catheter into the parenchyma or a ventricle;    mounting the anchor on the catheter and the skull of a patient to retain the catheter in position; and    infusing a therapeutic agent into the parenchyma or a ventricle for treatment of brain tissue.    
     
     
         16 . The method of  claim 15  in which the step of mounting the anchor on the catheter and the skull of a patient to retain the catheter in position includes: 
 inserting the catheter into the through hole of the anchor;  
 sliding the anchor along the catheter into engagement with the skull;  
 inserting a fastener through the opening of each standoff to fasten the anchor to the skull; and  
 placing the catheter in the channel.  
 
     
     
         17 . The method of  claim 16  in which the step of mounting the anchor on the catheter and the skull of a patient to retain the catheter in position further includes: 
 suturing the catheter in the channel.  
 
     
     
         18 . A system for intracranial delivery of therapeutic substances to a patient, the system comprising: 
 an elongate catheter having a lumen and at least one drug delivery orifice in fluid communication with the lumen;    an anchor formed of generally flexible, elastomeric material for mounting the catheter to the outer surface of the skull of the patient, the anchor having: 
 a through hole for receiving the catheter,  
 a channel, extending substantially from the through hole, into which a portion of the catheter may be inserted to retain the portion substantially parallel to the surface of the skull;  
 at least one flange for engaging the outer surface of the skull; and  
 at least one substantially rigid standoff mounted in the flange, the standoff having an opening for receiving a fastener to fasten the anchor to the skull; and  
   an implantable therapeutic substance infusion device, the catheter being directly or indirectly connected with the implantable therapeutic substance infusion device for infusion of therapeutic substance from the implantable therapeutic substance infusion device through the lumen and orifice(s) of the catheter.    
     
     
         19 . A catheter system for intracranial delivery of therapeutic substances to a patient, the system comprising: 
 an elongate catheter having a lumen and at least one drug delivery orifice in fluid communication with the lumen;    an anchor formed of generally flexible, elastomeric material for mounting the catheter to the outer surface of the skull of the patient, the anchor including: 
 orienting means for slidably receiving the catheter and orienting the catheter relative to the parenchyma;  
 means, generally adjacent the orienting means, for laterally receiving the catheter to retain a portion of the catheter substantially parallel to the surface of the skull;  
 generally flexible skull-engaging means for engaging the outer surface of the skull; and  
 substantially rigid means in the skull engaging means for receiving a fastener to fasten the anchor to the skull.  
   
     
     
         20 . A method of implanting a catheter for intracranial delivery of therapeutic substances to a patient, the method comprising: 
 forming a burr hole through the skull of the patient;    inserting the catheter through the burr hole into the parenchyma or a ventricle;    mounting an generally soft and pliable anchor on the catheter and moving the anchor along the catheter into engagement with the skull of a patient to retain the catheter in position, the anchor being formed of generally soft and pliable material and having at least one generally rigid standoff for receiving a screw or other fastener;    inserting a fastener through the opening of the standoff to fasten the anchor to the skull;    inserting a portion of the catheter laterally into a channel in the anchor to orient the portion of the catheter generally parallel to the surface of the skull; and    infusing a therapeutic agent into the parenchyma or a ventricle for treatment of brain tissue.    
     
     
         21 . The method of  claim 20  in which the step of mounting the anchor on the catheter and the skull of a patient to retain the catheter in position further includes: 
 suturing the catheter in the channel.  
 
     
     
         22 . The method of  claim 20  further comprising the step of directly or indirectly connecting the catheter to an implantable therapeutic substance infusion device.  
     
     
         23 . A method of implanting a catheter for intracranial delivery of therapeutic substances to a patient, the method comprising: 
 forming a burr hole through the skull of the patient;    placing a generally soft and pliable anchor adjacent the burr hole with the burr hole overlapping a through hole in the anchor, the anchor being formed of generally soft and pliable material and having at least one generally rigid standoff for receiving a screw or other fastener;    inserting the catheter through the through hole and burr hole into the parenchyma or a ventricle;    inserting a fastener through the opening of the standoff to fasten the anchor to the skull;    inserting a portion of the catheter laterally into a channel in the anchor to orient the portion of the catheter generally parallel to the surface of the skull; and    infusing a therapeutic agent into the parenchyma or a ventricle for treatment of brain tissue.    
     
     
         24 . The method of  claim 23  further comprising the step of suturing the catheter in the channel.  
     
     
         25 . The method of  claim 23  further comprising the step of directly or indirectly connecting the catheter to an implantable therapeutic substance infusion device.  
     
     
         26 . The method of  claim 23  wherein the step of inserting a fastener through the opening of the standoff to fasten the anchor to the skull is carried out before the step of inserting the catheter through the through hole and burr hole into the parenchyma or a ventricle.  
     
     
         27 . The method of  claim 23  wherein the step of inserting a fastener through the opening of the standoff to fasten the anchor to the skull is carried out after the step of inserting the catheter through the through hole and burr hole into the parenchyma or a ventricle.