Anchoring units for implantable electrical stimulation systems and methods of making and using

Abstract

An anchoring unit for an implantable lead includes a body, a plurality of anchoring members, and at least one connecting element coupling together at least two of the anchoring members that are positioned adjacent to one another. The body is configured and arranged for positioning along a portion of an outer surface of a lead. The body has a first end, a second end, and a longitudinal axis extending therebetween. The first end is configured and arranged for placement on the lead so that the first end is positioned more distally on the lead than the second end. Each anchoring member has a proximal end and a distal end. The proximal end of each anchoring member extends from the body and the distal end of each anchoring member anchors to patient tissue upon implantation of the anchoring unit into the patient.

What is claimed as new and desired to be protected by Letters Patent of the United States is: 
     
         1 . An implantable lead, comprising:
 a lead body having a proximal end portion, a distal end portion, and an outer surface;   a plurality of electrodes disposed along the distal end portion of the lead body;   a plurality of terminals disposed along the proximal end portion of the lead body;   a plurality of conductors electrically coupling the electrodes to the terminals; and   at least one anchoring unit disposed along the lead body, each of the at least one anchoring unit comprising
 a body configured and arranged for positioning along a portion of the outer surface of the lead body; and 
 at least one anchoring member having a proximal end, a distal end, and a longitudinal length, the proximal end of the at least one anchoring member extending from the body and the distal end of the at least one anchoring member configured and arranged for anchoring the anchoring unit to tissue of a patient upon implantation into the patient, wherein the distal end of the at least one anchoring member is wider than the proximal end of the at least one anchoring member. 
   
     
     
         2 . The implantable lead of  claim 1 , wherein the body defines at least one slit configured and arranged for facilitating folding of the at least one anchoring member against the outer surface of the lead body when the lead is inserted in a cannula of an insertion needle. 
     
     
         3 . The implantable lead of  claim 1 , wherein the distal end of the at least one anchoring member is arc-shaped. 
     
     
         4 . The implantable lead of  claim 3 , wherein a sum of arc lengths of the distal ends of the at least one anchoring member is no greater than 360°. 
     
     
         5 . The implantable lead of  claim 1 , wherein at least one of the at least one anchoring member comprises a leaf spring having a first end and a second end, the first end coupled to the body and the second end coupled to the distal end of the at least one of the at least one anchoring member. 
     
     
         6 . The anchoring unit of  claim 5 , wherein the leaf spring is configured and arranged to store potential energy and release the stored potential energy when the anchoring unit is implanted in a patient. 
     
     
         7 . An implantable lead, comprising:
 a lead body having a proximal end portion, a distal end portion, and an outer surface;   a plurality of electrodes disposed along the distal end portion of the lead body;   a plurality of terminals disposed along the proximal end portion of the lead body;   a plurality of conductors electrically coupling the electrodes to the terminals; and   at least one anchoring unit disposed along the lead body, each of the at least one anchoring unit comprising
 a body configured and arranged for positioning along a portion of the outer surface of the lead body; and 
 at least one anchoring member having a proximal end, a distal end, and a longitudinal length, the proximal end of the at least one anchoring member extending from the body and the distal end of the at least one anchoring member configured and arranged for anchoring the anchoring unit to tissue of a patient upon implantation into the patient, wherein the at least one anchoring member extends from the body such that the at least one anchoring member is arranged in a helical or spiral arrangement. 
   
     
     
         8 . The implantable lead of  claim 7 , wherein the body defines at least one slit configured and arranged for facilitating folding of the at least one anchoring member against the outer surface of the lead body when the lead is inserted in a cannula of an insertion needle. 
     
     
         9 . The implantable lead of  claim 7 , wherein the longitudinal length of the at least one anchoring member is defined by a leading edge and a lagging edge, wherein the leading edge is arced. 
     
     
         10 . The implantable lead of  claim 7 , wherein the distal end of the at least one anchoring member forms a rounded point. 
     
     
         11 . The implantable lead of  claim 7 , wherein the at least one anchoring member is a single anchoring member that extends from the body in the helical arrangement at least one revolution around a circumference of the body. 
     
     
         12 . An implantable lead, comprising:
 a lead body having a proximal end portion, a distal end portion, and an outer surface;   a plurality of electrodes disposed along the distal end portion of the lead body;   a plurality of terminals disposed along the proximal end portion of the lead body;   a plurality of conductors electrically coupling the electrodes to the terminals; and   at least one anchoring unit disposed along the lead body, each of the at least one anchoring unit comprising
 a body configured and arranged for positioning along a portion of the outer surface of the lead body; and 
 at least one anchoring member having a proximal end and a distal end, the proximal end extending from the body and the distal end configured and arranged for anchoring the anchoring unit to tissue of a patient upon implantation of the anchoring unit into the patient; wherein at least a portion of at least one of the at least one anchoring member extends in a direction that forms an angle with the body that is no greater than ninety degrees. 
   
     
     
         13 . The implantable lead of  claim 12 , wherein at least one of the at least one anchoring member comprises a proximal section and a distal section separated by an articulation. 
     
     
         14 . The implantable lead of  claim 13 , wherein the proximal section forms an angle with the body that is greater than ninety degrees and the distal section forms an angle with the body that is no greater than ninety degrees. 
     
     
         15 . The implantable lead of  claim 13 , wherein the proximal section defines a cutout. 
     
     
         16 . The implantable lead of  claim 12 , wherein at least one of the at least one anchoring member is curled. 
     
     
         17 . The implantable lead of  claim 12 , wherein at least one of the at least one anchoring member has an arc-shaped transverse profile. 
     
     
         18 . An electrical stimulating system comprising:
 the lead of  claim 1 ;   a control module configured and arranged to electrically couple to the proximal end portion of the lead, the control module comprising
 a housing, and 
 an electronic subassembly disposed in the housing; and 
   a connector for receiving the lead, the connector comprising
 a connector housing defining a port at the distal end of the connector, the port configured and arranged for receiving the proximal end portion of the lead, and 
 a plurality of connector contacts disposed in the connector housing, the connector contacts configured and arranged to couple to at least one of the plurality of terminals disposed on the proximal end portion of the lead. 
   
     
     
         19 . The electrical stimulating system of  claim 18 , further comprising a lead extension, wherein the connector is disposed on a distal end of the lead extension. 
     
     
         20 . A method of stimulating patient tissue comprising:
 providing the lead of  claim 1 ;   inserting the lead into a patient such that the electrodes of the lead are in proximity to the patient tissue to be stimulated;   coupling the lead to a control module;   generating electrical signals using the control module; and   propagating the generated electrical signals to the electrodes of the lead.