Patent ID: 8180461
Filing Date: 2012-05-15
Classification: A61N

Abstract:
1. A surgical instrumentation kit for minimally invasive implantation of a sacral stimulation lead through a foramen of the sacrum in a patient to electrically stimulate a sacral nerve, the sacral stimulation lead of the type having a lead body extending between a lead body proximal end and a lead body distal end, the lead body having a lead body diameter extending from the lead body proximal end and lead body distal end, the lead body further enclosing at least one electrical conductor extending between at least one proximally located electrical connector adapted to be coupled to an electrical stimulation pulse generator and at least one distally located stimulation electrode adapted to apply electrical stimulation to a sacral nerve, the kit comprising: the sacral stimulation lead: a needle having a needle diameter and needle length extending from a needle distal end capable of penetrating body tissue and a needle proximal end, the needle adapted to be grasped by a medical clinician with the needle distal end directed toward and inserted through an entry point of the skin or a skin incision posterior to the sacrum and guided along an insertion path into a foramen to locate at least a distal portion of the needle extending alongside a sacral nerve and a proximal portion of the needle extending from the entry point away from the patient's skin, wherein the needle defines the insertion path and comprises a first set of depth marks; and a dilator comprising a dilator body having a dilator body diameter, a dilator body length extending between a dilator proximal end and a dilator distal end, and a dilator body lumen extending from the dilator proximal end to the dilator distal end and having a dilator body lumen diameter sized in operative relation to the needle diameter to receive the needle therein, the dilator further comprising a dilator sheath having a dilator sheath diameter, a dilator sheath length extending between a dilator sheath proximal end and a dilator sheath distal end, and a dilator sheath lumen extending from the dilator sheath proximal end to the dilator sheath distal end and having a dilator sheath lumen diameter sized in operative relation to the lead body diameter and the dilator body diameter to selectively receive the dilator body and the lead body therein, the dilator sheath comprising a second set of depth marks, whereby the dilator sheath and dilator body are adapted to be assembled with the dilator body received within the dilator sheath lumen, the dilator body is adapted to be inserted over the needle proximal end to locate the needle within the dilator body lumen and to be advanced distally over the needle through the insertion path to dilate the insertion path to the dilator sheath diameter, the needle is adapted to be withdrawn through the dilator body lumen, the dilator body is adapted to be withdrawn through the dilator sheath lumen, the stimulation lead is adapted to be advanced through the dilator sheath lumen to locate the stimulation lead electrode into operative relation to the sacral nerve, and the dilator sheath is adapted to be withdrawn over the stimulation lead body, and wherein the first set of depth marks correlates to the second set of depth marks to indicate a depth of insertion of the needle and dilator sheath relative to the skin.