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.

1 . An anchoring unit for an implantable lead, the anchoring unit comprising:
 a body configured and arranged for positioning along a portion of an outer surface of a lead, the body having a first end and a second end and a longitudinal axis extending therebetween, the first end being configured and arranged for placement on the lead so that the first end is positioned more distally on the lead than the second end; and   a plurality of anchoring members, each anchoring member having a proximal end and a distal end, the proximal end of each anchoring member extending from the body and the distal end of each anchoring member configured and arranged for anchoring the anchoring unit to tissue of a patient upon implantation of the anchoring unit into the patient; and   at least one connecting element coupling together at least two of the anchoring members.   
     
     
         2 . The anchoring unit of  claim 1 , wherein the at least one connecting element comprises a sheath that at least partially covers at least one of the plurality of anchoring members. 
     
     
         3 . The anchoring unit of  claim 2 , wherein the sheath completely covers at least one of the plurality of anchoring members. 
     
     
         4 . The anchoring unit of  claim 1 , wherein the at least one connecting element comprises at least one bend or articulation. 
     
     
         5 . The anchoring unit of  claim 1 , wherein at least one of the plurality of anchoring members is configured and arranged to fold flat against the outer surface of the lead when the body is coupled to the lead and the lead is inserted in a cannula of an insertion needle. 
     
     
         6 . The anchoring unit of  claim 1 , wherein at least one of the plurality of anchor mg members extends from the second end of the body. 
     
     
         7 . The anchoring unit of  claim 1 , wherein at least one of the plurality of anchoring members extends from the second end of the body such that the at least one anchoring member forms an angle with the longitudinal axis of the body that is at least ninety degrees. 
     
     
         8 . The anchoring unit of  claim 1 , wherein at least one of the plurality of anchoring members extends from the first end of the body. 
     
     
         9 . The anchoring unit of  claim 1 , wherein the distal end and the proximal end of at least one of the plurality of anchoring members have equal widths. 
     
     
         10 . The anchoring unit of  claim 1 , wherein at least one of the plurality of anchoring members tapers such that the distal end of the at least one of the plurality of anchoring members has a width that is less than a width of the proximal end of the at least one of plurality of anchoring members. 
     
     
         11 . The anchoring unit of  claim 1 , wherein the at least one connecting element couples together the distal ends of the at least two anchoring members. 
     
     
         12 . The anchoring unit of  claim 1 , wherein the at least one connecting element couples together at least two adjacent anchoring members. 
     
     
         13 . The anchoring unit of  claim 1 , wherein at least one of the plurality of connecting elements has a thickness that is substantially less than at least one of the plurality of anchoring members. 
     
     
         14 . The anchoring unit of  claim 1 , wherein tissue ingrowth forms over at least a portion of the anchoring unit during the useful lifespan of the anchoring unit. 
     
     
         15 . A lead assembly comprising:
 a lead having a distal end and a proximal end, the lead comprising
 a plurality of electrodes disposed on the distal end of the lead, 
 a plurality of terminals disposed on the proximal end of the lead, 
 a plurality of conductors, each conductor electrically coupling at least one of the electrodes to at least one of the terminals; and 
   the anchoring unit of  claim 1 ;   
     
     
         16 . An electrical stimulating system comprising:
 the lead assembly of  claim 15 ;   a control module configured and arranged to electrically couple to the proximal end of the lead of the lead assembly, the control module comprising
 a housing, and 
 an electronic subassembly disposed in the housing; and 
   a connector for receiving the lead of the lead assembly, 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 of the lead of the lead assembly, 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 of the lead of the lead assembly. 
   
     
     
         17 . The electrical stimulating system of  claim 16 , wherein the connector is disposed on the control module. 
     
     
         18 . The electrical stimulating system of  claim 16 , wherein the connector is disposed on a distal end of a lead extension. 
     
     
         19 . The electrical stimulating system of  claim 18 , wherein the lead extension has a proximal end that couples with a second connector disposed on the control module. 
     
     
         20 . A method of stimulating patient tissue comprising:
 providing the lead assembly of  claim 15 ;   inserting the lead assembly into a patient such that the electrodes of the lead assembly are in proximity to the patient tissue to be stimulated;   coupling the lead assembly to a control module;   generating electrical signals using the control module; and   propagating the generated electrical signals to the electrodes of the lead assembly.