Suture sleeve anchoring device

An Anchoring assembly for affixing a lead body to tissue, said anchoring assembly comprising:

• a biocompatible suture sleeve having a tube wall defining an axial orifice, the tube wall including at least one external circumferential groove and surrounding the lead body which extends axially through the orifice;
• and
• a biocompatible anchoring device compressively manipulatable with hand tools from an open position to an affixed position, said anchoring device including:
• a first generally hemicircular portion adapted to be received within the side of a circumferential groove of said biocompatible suture sleeve;
• a second generally hemicircular portion adapted to be received within the other side of said circumferential groove of said biocompatible suture sleeve;
• a moderately stiff hinge means portion extending between said first and second generally hemispherical portions which is deformed by manipulation to cause said device to move from the open position to the affixed position;
• a first staple portion depending from said first generally hemicircular portion at and end of said first generally hemicircular portion farthest from said hinge portion and including a prong outwardly offset from the arc of said hemicircular portion in a manner which is adapted to puncture and then grip tissue as said device is manipulated from the open to the affixed position;
• and a second staple portion depending from said generally hemicircular portion at an end of said second generally hemicircular portion farthest from said hinge portion and including a prong outwardly offset from the arc of said hemicircular portion in a manner which is adapted to puncture and then grip tissue as said device is manipulated from the open to the affixed position.