Device and method for manipulating and inserting electrode arrays into neural tissues

Abstract

An insertion device for inserting a therapeutic device into organic tissue is disclosed and described. The device is particularly suited to insertion of such as nerve stimulating electrode arrays. The insertion device has at least one controllable positive pressure source (greater than atomospheric), two vacuum sources and a dual vacuum pressure control system. The positive pressure and the dual vacuum pressure control systems are manipulated to allow the manipulation and insertion or retrieval of a therapeutic device. The insertion device can be spatially manipulated by hand, without requiring other equipment for positioning the insertion device.

1 . A therapeutic device insertion device, comprising:
 a piston slidably contained in an inner chamber to allow movement of the piston from a first end to a second end of the inner chamber, said second end including a piston stop configured to limit motion of the piston;   a first vacuum operatively associated with the inner chamber at the first end providing a first pressure to the inner chamber at a back side of the piston proximate to the first end;   a second vacuum operatively associated with a first end of an axial chamber and providing a second pressure within the axial chamber, the second vacuum being operatively associated with the first end of the axial chamber and the second end of the inner chamber and providing a second pressure at a front side of the piston opposite the back side;   a pressure control system capable of independently controlling vacuum pressures supplied by each of the first and second vacuums;   an inserter slidably contained in a housing proximate the second end opposite the piston stop, said inserter including at least one aperture extending along a transverse axis of the inserter to allow fluid communication between the axial chamber and a tip of the inserter and the second pressure sufficient to retain a therapeutic device at the tip;   a position bias member operatively associated with the inserter and configured to bias the inserter toward the piston stop in a biased position.   
     
     
         2 . The insertion device as in  claim 1 , said inner chamber is concentrically oriented around at least a portion of the axial chamber, said axial chamber and said inner chamber being fluidly independent from one another. 
     
     
         3 . The insertion device as in  claim 1 , wherein said inserter includes at least one momentum transfer member extending through the piston stop so as to move said inserter by both mechanical and momentum transfer means. 
     
     
         4 . The insertion device as in  claim 1 , wherein said second pressure is reducible to pick up the therapeutic device. 
     
     
         5 . The insertion device as in  claim 1 , wherein a rate of insertion speed of approximately 8-12 m/s is achieved. 
     
     
         6 . The insertion device as in  claim 1 , wherein said tip is fitted with a sleeve to control the depth of the insertion. 
     
     
         7 . The insertion device as in  claim 6 , wherein said sleeve is curved. 
     
     
         8 . The insertion device as in  claim 1 , wherein said tip forms a cone. 
     
     
         9 . The insertion device as in  claim 1 , wherein said tip is coated with silicone. 
     
     
         10 . The insertion device as in  claim 1 , wherein said piston includes a momentum transfer member extending toward the second end and able to extend through said piston stop;
 said inserter including at least one aperture extending along the transverse axis of the inserter also allows fluid communication between the second end of the inner chamber, the axial chamber and a tip of the inserter;   and said housing including at least one vent oriented to allow fluid communication with the second end of the inner chamber when the inserter is in an unbiased position.   
     
     
         11 . The insertion device as in  claim 10 , wherein said first pressure is solenoid valved open to move said piston toward said second end and said first pressure is solenoid valved closed to move said piston toward said first end. 
     
     
         12 . The insertion device as in  claim 10 , wherein said second pressure is reducible to pickup a therapeutic device. 
     
     
         13 . The insertion device as in  claim 1 , wherein each of the first and second vacuums are fluidly independent from the other. 
     
     
         14 . The insertion device as in  claim 1 , wherein the position bias member is a spring.