Infusion device and method for infusing material into the brain of a patient

Abstract

A fluid infusion device and a method of using the same. The device includes an outer, flexible guide catheter having a distal end for introduction beneath the skull of a patient and a proximal end remaining external of the patient. A flexible infusion fiber is located within the guide catheter and has a distal end extending outwardly from the guide catheter to be located in a target area within the patient's brain. The infusion fiber can be fixed or axially movable within the guide catheter. In the latter embodiment, the proximal end of the infusion fiber extending outwardly from the guide catheter can be manipulated to locate the distal end of the infusion fiber in the target area. An infusion pump is connected to the proximal end of the infusion fiber to infuse a minute quantity of fluid at an extremely low flow rate into the brain of the patient.

1 . A delivery device for introducing fluid at a low flow rate into the brain within the skull of a patient, said device comprising a outer, flexible guide catheter having a distal end, a proximal end and a lumen therethrough, and a hollow, flexible infusion fiber having a distal end and a proximal end, said infusion fiber being located within the lumen of the guide catheter, said proximal end of the infusion fiber extending outwardly from the proximal end of the guide catheter, an inlet located at the proximal end of the infusion fiber for receiving fluid to pass fluid through the infusion fiber to the distal end of the infusion fiber positioned proximate to the brain of the patient.  
   
   
       2 . The delivery device as defined in  claim 1  wherein the infusion fiber is axially movable within the guide catheter to allow movement of the distal end of the infusion fiber outwardly from the distal end of the guide catheter.  
   
   
       3 . The delivery device as defined in  claim 1  wherein the infusion fiber is immovably within the guide catheter and the distal end of the infusion fiber extends a fixed distance from the distal end of the guide catheter.  
   
   
       4 . The delivery device as defined in  claim 1  wherein the inner diameter of the flexible infusion fiber is about 100 microns.  
   
   
       5 . The delivery device as defined in  claim 1  wherein the outer diameter of the flexible infusion fiber is about 170 microns.  
   
   
       6 . The delivery device as defined in  claim 1  wherein the flexible infusion fiber is comprised of a material selected from the group consisting of vitreous silica, fused silica, and polyurethane.  
   
   
       7 . The delivery device as defined in  claim 1  wherein the flexible infusion fiber has a plurality of lumens.  
   
   
       8 . The delivery device as defined in  claim 1  wherein the distal end of the infusion fiber is extendable from about 0.5 mm. to about 50 mm. from the distal end of the guide catheter.  
   
   
       9 . The delivery device as defined in  claim 8  wherein the distal end of the infusion fiber is extendable from about 1.0 mm. to about 20 mm. from the distal end of the guide catheter.  
   
   
       10 . The delivery device as defined in  claim 1  wherein said guide catheter is marked so as to be able to detect the location of the distal end of the outer guide catheter.  
   
   
       11 . The delivery device as defined in  claim 10  wherein said guide catheter is radioopaque along at least a portion of its length.  
   
   
       12 . The delivery device as defined in of  claim 10  wherein said guide catheter is radioopaque and MRI opaque along at least a portion of its length.  
   
   
       13 . The delivery device as defined in  claim 1  further including a stereotactic frame to locate the distal end of the guide catheter at a desired position within the brain of a patient.  
   
   
       14 . An infusion system for introducing fluid at a low flow rate into the brain within the skull of a patient, said device comprising a outer, flexible guide catheter having a distal end, a proximal end and a lumen therethrough, and a flexible infusion fiber having a distal end and a proximal end, said infusion fiber being located within the lumen of the guide catheter, said proximal end of the infusion fiber extending outwardly from the proximal end of the guide catheter, an inlet located at the proximal end of the infusion fiber for receiving fluid to pass fluid through the infusion fiber to the distal end or the infusion fiber positioned proximate to the brain of the patient and a pump for introducing fluid into the proximal end of the flexible infusion fiber.  
   
   
       15 . The infusion system as defined in  claim 14  wherein the infusion fiber is axially movable within the lumen of the guide catheter to allow movement of the distal end of the infusion fiber outwardly from the distal end of the guide catheter.  
   
   
       16 . The infusion system as defined in  claim 14  wherein the infusion fiber is immovably within the guide catheter and the distal end of the infusion fiber extends a fixed distance from the distal end of the guide catheter.  
   
   
       17 . The infusion system as defined in  claim 14  wherein the pump is a syringe.  
   
   
       18 . The infusion system as defined in  claim 14  wherein the pump introduces a liquid into the proximal end of the infusion fiber at a rate of between about 1.0 nl/min to 5.0 microliters/min.  
   
   
       19 . The infusion system as defined in  claim 18  wherein the pump introduces a liquid into the proximal end of the infusion fiber at a rate of between about 10 nl/min to about 1 microliter/min.  
   
   
       20 . The infusion system as defined in  claim 18  wherein the pump introduces a liquid into the proximal end of the infusion fiber at a rate of between about 100 nl/min to about 0.5 microliters/min.  
   
   
       21 . The infusion system as defined in  claim 14  wherein flexible infusion fiber has a plurality of lumens.  
   
   
       22 . The infusion system as defined in  claim 21  wherein at least one of the lumens has an electrode positioned therein.  
   
   
       23 . A method of infusing a fluid at a low flow rate into the brain of a patient, said method comprising the steps of: 
 providing a guide catheter comprised of a flexible material and having a distal and a proximal end,    providing a flexible infusion fiber having a distal end and a proximal end;    locating the flexible infusion fiber within the guide catheter such that the proximal end of the infusion fiber extends outwardly from the proximal end of the guide catheter and the distal end of the infusion fiber extends outwardly from the distal end of the guide catheter,    locating the guide catheter at a predetermined location within the brain of a patient,    introducing fluid into the proximal end of the infusion fiber to cause fluid to pass from the distal end of the infusion fiber at the desired location within the brain of a patient.    
   
   
       24 . The method of infusing a fluid as defined in  claim 23  wherein the step of locating the flexible infusion fiber within the guide catheter comprises locating the flexible infusion fiber to be axially movable within the guide catheter.  
   
   
       25 . The method of infusing a fluid as defined in  claim 23  further including the step of extending the infusion fiber outwardly from the distal end of the guide catheter to locate the distal end of the infusion catheter at a desired location within the brain of a patient.  
   
   
       26 . The method of infusing a fluid as defined in  claim 23  wherein the step of introducing fluid into the proximal end of the infusion fiber comprises introducing a liquid at the rate of about 1.0 nl/min to 5.0 microliters/min.  
   
   
       27 . The method of infusing fluid into a patient as defined in  claim 23  further including the step of securing the shield catheter to the scalp of a patient.  
   
   
       28 . The method of infusing fluid into a patient as defined in  claim 27  wherein the seep of securing the outer shield catheter to the scalp of a patient comprises suturing the shield catheter to the scalp of a patient.  
   
   
       29 . The method of infusing a fluid as defined in  claim 23  wherein the step of providing a flexible infusion fiber comprises providing a flexible infusion fiber having an inner diameter of about 100 microns.  
   
   
       30 . The method of infusing a fluid as defined in  claim 23  wherein the step of extending the infusion fiber outwardly from the distal end of the guide catheter comprises extending the distal end of the infusion fiber from about 0.5 mm. to about 50 mm. from the distal end of the guide catheter.  
   
   
       31 . The method of infusing a fluid as defined in  claim 23  wherein the step of providing a guide catheter comprises providing a guide catheter having a marking material to enable the position of the guide catheter to be determined.  
   
   
       32 . A fixation device for securing a catheter entering the skull of a patient through a burr hole in the skull of a patient, the affixation device comprising a base cap having an opening formed therein, said base cap adapted to be affixed to the skull of a patient to align the opening over a burr hole in a patient, the base cap further having a tightener adapted to secure the catheter passing through the opening of the base cap.  
   
   
       33 . The fixation device as defined in  claim 32  wherein the base cap includes holes for the introduction of screws to secure the affixation device to the skull of a patient.  
   
   
       34 . The fixation device as defined in  claim 32  wherein slits are formed on the base cap to receive and hold the catheter.  
   
   
       35 . The fixation device as defined in  claim 32  further including a cap that attaches to the base cap by means of a snap fit to enclose the catheter where the catheter passes through a burr hole in a patient.  
   
   
       36 . The fixation device as defined in  claim 32  wherein the tightener comprises a screw threadedly engaged to the base cap.