Patent Publication Number: US-8983625-B2

Title: Systems and methods for electrically stimulating patient tissue on or around one or more bony structures

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 13/899,350 filed May 21, 2013, issued as U.S. Pat. No. 8,768,488 on Jul. 1, 2014, which claims the benefit under 35 §119(e) of U.S. Provisional Patent Application Ser. No. 61/651,840 filed on May 25, 2012, all of which are incorporated herein by reference. 
    
    
     FIELD 
     The present invention is directed to the area of implantable electrical stimulation systems and methods of making and using the systems. The present invention is also directed to implantable electrical stimulation leads configured and arranged for anchoring to one or more bony structures in proximity to a target stimulation region, as well as methods of making and using the leads and electrical stimulation systems. 
     BACKGROUND 
     Implantable electrical stimulation systems have proven therapeutic in a variety of diseases and disorders. For example, spinal cord stimulation systems have been used as a therapeutic modality for the treatment of chronic pain syndromes. Peripheral nerve stimulation has been used to treat incontinence, as well as a number of other applications under investigation. Functional electrical stimulation systems have been applied to restore some functionality to paralyzed extremities in spinal cord injury patients. 
     Stimulators have been developed to provide therapy for a variety of treatments. A stimulator can include a control module (with a pulse generator), one or more leads, and an array of stimulator electrodes on each lead. The stimulator electrodes are in contact with or near the nerves, muscles, or other tissue to be stimulated. The pulse generator in the control module generates electrical pulses that are delivered by the electrodes to body tissue. 
     Dorsal root ganglia are nodules of cell bodies disposed along the dorsal roots of spinal nerves. Dorsal root ganglia are disposed external to the epidural space. Dorsal root ganglia, however, are disposed in proximity to the spinal cord and the vertebral column. 
     BRIEF SUMMARY 
     In one embodiment, an implantable lead assembly for providing electrical stimulation to a patient includes a lead body having a proximal end, a distal end, and a longitudinal length; at least one terminal disposed at the proximal end of the lead body; and an orthopedic implant coupled to the distal end of the lead body. The orthopedic implant is configured and arranged for anchoring to at least one bony structure. The orthopedic implant includes an elongated orthopedic implant body having a first end and an opposing second end. At least one mounting region is disposed along the orthopedic implant body. The at least one mounting region is configured and arranged for anchoring the orthopedic implant to the at least one bony structure. At least one stimulation region is disposed along the orthopedic implant body. At least one electrode is disposed along the at least one stimulation region. At least one conductor electrically couples the at least one terminal to the at least one electrode. 
     In another embodiment, a lead anchoring assembly for providing electrical stimulation includes an orthopedic implant configured and arranged to receive a distal end of a lead body of a first lead. The orthopedic implant is configured and arranged for anchoring to at least one bony structure. The orthopedic implant includes an orthopedic implant body having a first end, a second end opposite to the first end, a first side, a second side opposite to the first side, a top surface, and a bottom surface opposite to the top surface. At least one mounting region is disposed along the first end of the orthopedic implant body. The at least one mounting region is configured and arranged for anchoring the orthopedic implant to the at least one bony structure. A lead anchoring region is disposed along the orthopedic implant body. The lead anchoring region is configured and arranged for receiving the first lead and for fastening the first lead to the orthopedic implant. 
     In yet another embodiment, an implantable lead assembly for providing electrical stimulation to a patient includes a lead body having a proximal end, a distal end, and a longitudinal length; at least one terminal disposed at the proximal end of the lead body; and an orthopedic implant coupled to the distal end of the lead body. The orthopedic implant is configured and arranged for anchoring to at least one bony structure. The orthopedic implant includes a head configured and arranged for receiving a fastening tool. An elongated shaft is coupled to the head. The shaft has a first end and an opposing second end. The first end couples to the head. A tip is disposed on the second end of the shaft. The tip is configured and arranged to anchor to the at least one bony structure. At least one electrode is disposed along the tip of the orthopedic implant. At least one conductor electrically couples the at least one terminal to the at least one electrode. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Non-limiting and non-exhaustive embodiments of the present invention are described with reference to the following drawings. In the drawings, like reference numerals refer to like parts throughout the various figures unless otherwise specified. 
       For a better understanding of the present invention, reference will be made to the following Detailed Description, which is to be read in association with the accompanying drawings, wherein: 
         FIG. 1  is a schematic view of one embodiment of an electrical stimulation system that includes a paddle body coupled to a control module via lead bodies, according to the invention; 
         FIG. 2  is a schematic view of another embodiment of an electrical stimulation system that includes a percutaneous lead body coupled to a control module via a lead body, according to the invention; 
         FIG. 3A  is a schematic view of one embodiment of a plurality of connector assemblies disposed in the control module of  FIG. 1 , the connector assemblies configured and arranged to receive the proximal portions of the lead bodies of  FIG. 1 , according to the invention; 
         FIG. 3B  is a schematic view of one embodiment of a connector assembly disposed in the control module of  FIG. 2 , the connector assembly configured and arranged to receive the proximal portion of one of the lead body of  FIG. 2 , according to the invention; 
         FIG. 3C  is a schematic view of one embodiment of a proximal portion of the lead body of  FIG. 2 , a lead extension, and the control module of  FIG. 2 , the lead extension configured and arranged to couple the lead body to the control module, according to the invention; 
         FIG. 4A  is a schematic transverse cross-sectional view of spinal nerves extending from a spinal cord, the spinal nerves including dorsal root ganglia; 
         FIG. 4B  is a schematic perspective view of a portion of the spinal cord of  FIG. 4A  disposed in a portion of a vertebral column with the dorsal root ganglia of  FIG. 4A  extending outward from the vertebral column; 
         FIG. 4C  is a schematic top view of a portion of the spinal cord of  FIG. 4A  disposed in a vertebral foramen defined in a vertebra of the vertebral column of  FIG. 4B , the vertebra also defining intervertebral foramina extending between an outer surface of the vertebra and the vertebral foramen, the intervertebral foramina providing an opening through which the dorsal root ganglia of  FIG. 4B  can extend outward from the spinal cord of  FIG. 4B ; 
         FIG. 4D  is a schematic side view of two vertebrae of the vertebral column of  FIG. 4B , the vertebrae defining an intervertebral foramen through which the dorsal root ganglia of  FIG. 4B  can extend outward from the spinal cord of  FIG. 4B ; 
         FIG. 5A  is a schematic bottom view of one embodiment of an orthopedic implant suitable for anchoring to one or more of the vertebrae of  FIG. 4B , according to the invention; 
         FIG. 5B  is a schematic side view of one embodiment of the orthopedic implant of  FIG. 5A , according to the invention; 
         FIG. 5C  is a schematic top view of one embodiment of the orthopedic implant of  FIG. 5A  anchored to two of the vertebrae of  FIG. 4B , according to the invention; 
         FIG. 5D  is a schematic side view of one embodiment of the orthopedic implant of  FIG. 5A  anchored to two of the vertebrae of  FIG. 4B , according to the invention; 
         FIG. 6A  is a schematic bottom view of a second embodiment of an orthopedic implant suitable for anchoring to one or more of the vertebrae of  FIG. 4B , according to the invention; 
         FIG. 6B  is a schematic side view of one embodiment of the orthopedic implant of  FIG. 6A , according to the invention; 
         FIG. 6C  is a schematic top view of one embodiment of the orthopedic implant of  FIG. 6A  anchored to two of the vertebrae of  FIG. 4B , according to the invention; 
         FIG. 6D  is a schematic side view of one embodiment of the orthopedic implant of  FIG. 6A  anchored to two of the vertebrae of  FIG. 4B , according to the invention; 
         FIG. 7A  is a schematic bottom view of a third embodiment of an orthopedic implant suitable for anchoring to one or more of the vertebrae of  FIG. 4B , according to the invention; 
         FIG. 7B  is a schematic side view of one embodiment of the orthopedic implant of  FIG. 7A , according to the invention; 
         FIG. 7C  is a schematic top view of one embodiment of the orthopedic implant of  FIG. 7A  anchored to two of the vertebrae of  FIG. 4B , according to the invention; 
         FIG. 7D  is a schematic side view of one embodiment of the orthopedic implant of  FIG. 7A  anchored to two of the vertebrae of  FIG. 4B , according to the invention; 
         FIG. 8A  is a schematic side view of a fourth embodiment of an orthopedic implant suitable for anchoring to one of the vertebrae of  FIG. 4B , according to the invention; 
         FIG. 8B  is a schematic side view of one embodiment of the orthopedic implant of  FIG. 8A  anchored to one of the vertebrae of  FIG. 4B , according to the invention; 
         FIG. 8C  is a schematic side view of another embodiment of the orthopedic implant of  FIG. 8A  anchored to one of the vertebrae of  FIG. 4B , the orthopedic implant having a bendable electrode, according to the invention; 
         FIG. 8D  is a schematic top view of one embodiment of the orthopedic implant of  FIG. 8C  anchored to one of the vertebrae of  FIG. 4B , according to the invention; 
         FIG. 9A  is a schematic top view of a fifth embodiment of an orthopedic implant that includes an anchoring unit suitable for anchoring one or more leads to one or more of the vertebrae of  FIG. 4B , according to the invention; 
         FIG. 9B  is a schematic side view of one embodiment of the orthopedic implant of  FIG. 9A , according to the invention; 
         FIG. 9C  is a schematic top view of one embodiment of two percutaneous leads fastened to the orthopedic implant of  FIG. 9A , according to the invention; 
         FIG. 9D  is a schematic top view of one embodiment of the two percutaneous leads of  FIG. 9C  fastened to the orthopedic implant of  FIG. 9A , and the orthopedic implant anchored to two of the vertebrae of  FIG. 4B , according to the invention; 
         FIG. 9E  is a schematic top view of one embodiment of a paddle lead fastened to the orthopedic implant of  FIG. 9A , according to the invention; and 
         FIG. 10  is a schematic overview of one embodiment of components of an electrical stimulation system, according to the invention. 
     
    
    
     DETAILED DESCRIPTION 
     The present invention is directed to the area of implantable electrical stimulation systems and methods of making and using the systems. The present invention is also directed to implantable electrical stimulation leads configured and arranged for anchoring to one or more bony structures in proximity to a target stimulation region, as well as methods of making and using the leads and electrical stimulation systems. 
     Suitable implantable electrical stimulation systems include, but are not limited to, an electrode lead (“lead”) with one or more electrodes disposed on a distal end of the lead and one or more terminals disposed on one or more proximal ends of the lead. Leads include, for example, deep brain stimulation leads, percutaneous leads, paddle leads, and cuff leads. Examples of electrical stimulation systems with leads are found in, for example, U.S. Pat. Nos. 6,181,969; 6,516,227; 6,609,029; 6,609,032; 6,741,892; 7,244,150; 7,672,734; 7,761,165; 7,949,395; 7,974,706; 8,175,710; 8,224,450; and 8,364,278; and U.S. Patent Application Publication No. 2007/0150036, all of which are incorporated by reference. 
       FIG. 1  illustrates schematically one embodiment of an electrical stimulation system  100 . The electrical stimulation system includes a control module (e.g., a stimulator or pulse generator)  102  and a lead  103 . The lead  103  including a paddle body  104  and one or more lead bodies  106  coupling the control module  102  to the paddle body  104 . The paddle body  104  and the one or more lead bodies  106  form the lead  103 . The paddle body  104  typically includes a plurality of electrodes  134  that form an array of electrodes  133 . The control module  102  typically includes an electronic subassembly  110  and an optional power source  120  disposed in a sealed housing  114 . In  FIG. 1 , two lead bodies  106  are shown coupled to the control module  102 . 
     The control module  102  typically includes one or more connector assemblies  144  into which the proximal end of the one or more lead bodies  106  can be plugged to make an electrical connection via connector contacts (e.g.,  316  in  FIG. 3A ) disposed in the connector assembly  144  and terminals (e.g.,  310  in  FIG. 3A ) on each of the one or more lead bodies  106 . The connector contacts are coupled to the electronic subassembly  110  and the terminals are coupled to the electrodes  134 . In  FIG. 1 , two connector assemblies  144  are shown. 
     The one or more connector assemblies  144  may be disposed in a header  150 . The header  150  provides a protective covering over the one or more connector assemblies  144 . The header  150  may be formed using any suitable process including, for example, casting, molding (including injection molding), and the like. In addition, one or more lead extensions  324  (see  FIG. 3C ) can be disposed between the one or more lead bodies  106  and the control module  102  to extend the distance between the one or more lead bodies  106  and the control module  102 . 
     It will be understood that the electrical stimulation system can include more, fewer, or different components and can have a variety of different configurations including those configurations disclosed in the electrical stimulation system references cited herein. For example, instead of a paddle body  104 , the electrodes  134  can be disposed in an array at or near the distal end of a lead body  106 ′ forming a percutaneous lead  103 , as illustrated in  FIG. 2 . The percutaneous lead may be isodiametric along the length of the lead body  106 ″. The lead body  106 ′ can be coupled with a control module  102 ′ with a single connector assembly  144 . 
     The electrical stimulation system or components of the electrical stimulation system, including one or more of the lead bodies  106 , the control module  102 , and, in the case of a paddle lead, the paddle body  104 , are typically implanted into the body of a patient. The electrical stimulation system can be used for a variety of applications including, but not limited to, spinal cord stimulation, brain stimulation, neural stimulation, muscle activation via stimulation of nerves innervating muscle, and the like. 
     The electrodes  134  can be formed using any conductive, biocompatible material. Examples of suitable materials include metals, alloys, conductive polymers, conductive carbon, and the like, as well as combinations thereof. In at least some embodiments, one or more of the electrodes  134  are formed from one or more of: platinum, platinum iridium, palladium, titanium, or rhenium. 
     The number of electrodes  134  in the array of electrodes  133  may vary. For example, there can be two, three, four, five, six, seven, eight, nine, ten, eleven, twelve, thirteen, fourteen, fifteen, sixteen, or more electrodes  134 . As will be recognized, other numbers of electrodes  134  may also be used. In  FIG. 1 , sixteen electrodes  134  are shown. The electrodes  134  can be formed in any suitable shape including, for example, round, oval, triangular, rectangular, pentagonal, hexagonal, heptagonal, octagonal, or the like. 
     The electrodes of the paddle body  104  or one or more lead bodies  106  are typically disposed in, or separated by, a non-conductive, biocompatible material including, for example, silicone, polyurethane, and the like or combinations thereof. The paddle body  104  and one or more lead bodies  106  may be formed in the desired shape by any process including, for example, molding (including injection molding), casting, and the like. Electrodes and connecting wires can be disposed onto or within a paddle body either prior to or subsequent to a molding or casting process. The non-conductive material typically extends from the distal end of the lead  103  to the proximal end of each of the one or more lead bodies  106 . The non-conductive, biocompatible material of the paddle body  104  and the one or more lead bodies  106  may be the same or different. The paddle body  104  and the one or more lead bodies  106  may be a unitary structure or can be formed as two separate structures that are permanently or detachably coupled together. 
     Terminals (e.g.,  310  in  FIG. 3A ) are typically disposed at the proximal end of the one or more lead bodies  106  for connection to corresponding conductive contacts (e.g.,  316  in  FIG. 3A ) in connector assemblies (e.g.,  144  in  FIG. 1 ) disposed on, for example, the control module  102  (or to other devices, such as conductive contacts on a lead extension, an operating room cable, a splitter, an adaptor, or the like). 
     Conductive wires (not shown) extend from the terminals (e.g.,  310  in  FIG. 3A ) to the electrodes  134 . Typically, one or more electrodes  134  are electrically coupled to a terminal (e.g.,  310  in  FIG. 3A ). In some embodiments, each terminal (e.g.,  310  in  FIG. 3A ) is only coupled to one electrode  134 . 
     The conductive wires may be embedded in the non-conductive material of the lead or can be disposed in one or more lumens (not shown) extending along the lead. In some embodiments, there is an individual lumen for each conductive wire. In other embodiments, two or more conductive wires may extend through a lumen. There may also be one or more lumens (not shown) that open at, or near, the proximal end of the lead, for example, for inserting a stylet rod to facilitate placement of the lead within a body of a patient. Additionally, there may also be one or more lumens (not shown) that open at, or near, the distal end of the lead, for example, for infusion of drugs or medication into the site of implantation of the paddle body  104 . The one or more lumens may, optionally, be flushed continually, or on a regular basis, with saline, epidural fluid, or the like. The one or more lumens can be permanently or removably sealable at the distal end. 
     As discussed above, the one or more lead bodies  106  may be coupled to the one or more connector assemblies  144  disposed on the control module  102 . The control module  102  can include any suitable number of connector assemblies  144  including, for example, two three, four, five, six, seven, eight, or more connector assemblies  144 . It will be understood that other numbers of connector assemblies  144  may be used instead. In  FIG. 1 , each of the two lead bodies  106  includes eight terminals that are shown coupled with eight conductive contacts disposed in a different one of two different connector assemblies  144 . 
       FIG. 3A  is a schematic side view of one embodiment of a plurality of connector assemblies  144  disposed on the control module  102 . In at least some embodiments, the control module  102  includes two connector assemblies  144 . In at least some embodiments, the control module  102  includes four connector assemblies  144 . In  FIG. 3A , proximal ends  306  of the plurality of lead bodies  106  are shown configured and arranged for insertion to the control module  102 .  FIG. 3B  is a schematic side view of one embodiment of a single connector assembly  144  disposed on the control module  102 ′. In  FIG. 3B , the proximal end  306  of the single lead body  106 ′ is shown configured and arranged for insertion to the control module  102 ′. 
     In  FIGS. 3A and 3B , the one or more connector assemblies  144  are disposed in the header  150 . In at least some embodiments, the header  150  defines one or more ports  304  into which the proximal end(s)  306  of the one or more lead bodies  106 / 106 ′ with terminals  310  can be inserted, as shown by directional arrows  312 , in order to gain access to the connector contacts disposed in the one or more connector assemblies  144 . 
     The one or more connector assemblies  144  each include a connector housing  314  and a plurality of connector contacts  316  disposed therein. Typically, the connector housing  314  defines a port (not shown) that provides access to the plurality of connector contacts  316 . In at least some embodiments, one or more of the connector assemblies  144  further includes a retaining element  318  configured and arranged to fasten the corresponding lead body  106 / 106 ′ to the connector assembly  144  when the lead body  106 / 106 ′ is inserted into the connector assembly  144  to prevent undesired detachment of the lead body  106 / 106 ′ from the connector assembly  144 . For example, the retaining element  318  may include an aperture  320  through which a fastener (e.g., a set screw, pin, or the like) may be inserted and secured against an inserted lead body  106 / 106 ′. 
     When the one or more lead bodies  106 / 106 ′ are inserted into the one or more ports  304 , the connector contacts  316  can be aligned with the terminals  310  disposed on the one or more lead bodies  106 / 106 ′ to electrically couple the control module  102  to the electrodes ( 134  of  FIG. 1 ) disposed at a distal end of the one or more lead bodies  106 . Examples of connector assemblies in control modules are found in, for example, U.S. Pat. Nos. 7,244,150 and 8,224,450, which are incorporated by reference. 
     In at least some embodiments, the electrical stimulation system includes one or more lead extensions. The one or more lead bodies  106 / 106 ′ can be coupled to one or more lead extensions which, in turn, are coupled to the control module  102 / 102 ′. In  FIG. 3C , a lead extension connector assembly  322  is disposed on a lead extension  324 . The lead extension connector assembly  322  is shown disposed at a distal end  326  of the lead extension  324 . The lead extension connector assembly  322  includes a contact housing  328 . The contact housing  328  defines at least one port  330  into which a proximal end  306  of the lead body  106 ′ with terminals  310  can be inserted, as shown by directional arrow  338 . The lead extension connector assembly  322  also includes a plurality of connector contacts  340 . When the lead body  106 ′ is inserted into the port  330 , the connector contacts  340  disposed in the contact housing  328  can be aligned with the terminals  310  on the lead body  106  to electrically couple the lead extension  324  to the electrodes ( 134  of  FIG. 1 ) disposed at a distal end (not shown) of the lead body  106 ′. 
     The proximal end of a lead extension can be similarly configured and arranged as a proximal end of a lead body. The lead extension  324  may include a plurality of conductive wires (not shown) that electrically couple the connector contacts  340  to terminal on a proximal end  348  of the lead extension  324 . The conductive wires disposed in the lead extension  324  can be electrically coupled to a plurality of terminals (not shown) disposed on the proximal end  348  of the lead extension  324 . In at least some embodiments, the proximal end  348  of the lead extension  324  is configured and arranged for insertion into a lead extension connector assembly disposed in another lead extension. In other embodiments (as shown in  FIG. 3C ), the proximal end  348  of the lead extension  324  is configured and arranged for insertion into the connector assembly  144  disposed on the control module  102 ′. 
     It will be understood that the control modules  102 / 102 ′ can receive either lead bodies  106 / 106 ′ or lead extensions  324 . It will also be understood that the electrical stimulation system  100  can include a plurality of lead extensions  224 . For example, each of the lead bodies  106  shown in  FIGS. 1 and 3A  can, alternatively, be coupled to a different lead extension  224  which, in turn, are each coupled to different ports of a two-port control module, such as the control module  102  of  FIGS. 1 and 3A . 
     Turning to  FIG. 4A , some target stimulation locations are located in proximity to one or more bony structures. When stimulating a region in proximity to one or more bony structures, it may be desirable to anchor the lead to the bony structure in order to prevent migration of the distal end of the lead which, in at least some cases, may disrupt efficacious stimulation. 
     One potential target stimulation location in proximity to a bony structure is the dorsal root ganglia.  FIG. 4A  schematically illustrates a transverse cross-sectional view of a spinal cord  402  surrounded by dura  404 . The spinal cord  402  includes a plurality of levels from which spinal nerves  412   a  and  412   b  extend. In at least some spinal cord levels, the spinal nerves  412   a  and  412   b  extend bilaterally from the spinal cord  402 . In  FIG. 4A , the spinal nerves  412   a  and  412   b  attach to the spinal cord  402  via corresponding dorsal roots  414   a  and  414   b  and corresponding ventral (or anterior) roots  416   a  and  416   b . Typically, the dorsal roots  414   a  and  414   b  relay sensory information into the spinal cord  402  and the ventral roots  416   a  and  416   b  relay motor information outward from the spinal cord  402 . Dorsal root ganglia (“DRG”)  420   a  and  420   b  are nodules of cell bodies that are disposed along the dorsal roots  416   a  and  416   b  in proximity to the spinal cord  402 . 
       FIG. 4B  schematically illustrates a perspective view of a portion of the spinal cord  402  disposed along a portion of a vertebral column  430 . The vertebral column  430  includes a plurality of stacked vertebrae, such as vertebrae  432   a  and  432   b , and a plurality of DRGs  420   a  and  420   b  extending outwardly bilaterally from the spinal cord  402 . 
       FIG. 4C  schematically illustrates a top view of a portion of the spinal cord  402  and dura  404  disposed in a vertebral foramen  440  defined in the vertebra  432   b . The vertebrae, such as the vertebrae  432   a  and  432   b , are stacked together and the vertebral foramina  440  of the vertebrae collectively form a spinal canal through which the spinal cord  402  extends. The space within the spinal canal between the dura  404  and the walls of the vertebral foramen  440  defines the epidural space  442 . Intervertebral foramina  446   a  and  446   b , defined bilaterally along sides of the vertebra  432   b , form openings through the vertebra  432   b  between the epidural space  442  and the environment external to the vertebra  432   b.    
       FIG. 4D  schematically illustrates a side view of two vertebrae  432   a  and  432   b  coupled to one another by a disc  444 . In  FIG. 4D , the intervertebral foramen  446   b  is shown defined between the vertebrae  432   a  and  432   b . The intervertebral foramen  446   b  provides an opening for one or more of the dorsal root  414   b , ventral root  416   b , and DRG  420   b  to extend outwardly from the spinal cord  402 . 
     Turning to  FIG. 5A , as herein described one or more leads can be anchored to one or more bony structures in proximity to a target stimulation location. In at least some embodiments, the one or more leads are anchored to one or more vertebrae in proximity to the target stimulation location. It will be understood that the systems and methods discussed herein may be applicable to other bony structures of the patient including, for example, the skull, pelvis, scapulae, humerus, femur, or the like. In at least some embodiments, the target stimulation location is the DRG. It will be understood that the systems and methods discussed herein may be applicable to other target stimulation locations within the patient including, for example, other portions of the sensory nerves (e.g., the dorsal root or the ventral root), or other patient tissue in proximity to one or more other bony structures, besides the vertebrae. 
     Individuals with spinal orthopedic ailments may receive one or more orthopedic implants (e.g., rods, plates, straps, screws, or the like or combinations thereof) to provide therapy to the patient. In some cases, the orthopedic implants may span between two or more bony structures. For example, the orthopedic implant may span between two or more of the patient&#39;s vertebrae at a particular spinal cord level. In at least some embodiments, the one or more leads can be coupled to the one or more orthopedic implants such that the electrodes of the one or more lead are disposed on the orthopedic implant. In which case, the electrodes can be disposed along the orthopedic implant such that the electrodes are positioned in proximity to a target stimulation location in proximity to the one or more bony structures at the particular spinal cord level, such as the particular DRG disposed in proximity to the spinal cord level across which the orthopedic implant spans. 
     Orthopedic implants can be implanted into the patient in any suitable manner including, for example, using a series of hollow introducers. Further description of a series of hollow introducers can be found in U.S. Provisional Patent Application Ser. No. 61/651,815, incorporated herein by reference. 
       FIG. 5A  is a schematic bottom view of one embodiment of a distal end of a body of a lead  502  coupled to an orthopedic implant  504 .  FIG. 5B  is a schematic side view of one embodiment of the distal end of the body of the lead  502  coupled to the orthopedic implant  504 . The lead  502  includes a plurality of terminals (see e.g., terminals  310  of  FIGS. 3A-3C ) disposed along a proximal end of the body of the lead  502 . The terminals are configured and arranged for electrically coupling with the control module (see e.g.,  102  in  FIG. 1 ) either directly, or via one or more intermediate components, such as a lead extension (see e.g.,  324  of  FIG. 3C ). 
     The orthopedic implant  504  includes an elongated body  506  with one or more mounting regions  508  and one or more stimulation regions  510 . In  FIGS. 5A-5B , the body  506  is shown with two mounting regions  508  disposed on opposing ends of the body  506 . In at least some embodiments, the one or more stimulation regions  510  are disposed between two or more mounting regions  508 . 
     In at least some embodiments, the one or more mounting regions  508  are coupled to the one or more stimulation regions  510  via one or more transition regions  512 . In at least some embodiments, the one or more mounting regions  508  are planar. In at least some embodiments, the one or more stimulation regions  510  are planar. In  FIGS. 5A-5B , the mounting regions  508  and the stimulation region  510  are shown extending parallel to one another, while the transition regions  512  are shown as bent, or angled, regions that are not parallel to either the mounting regions  508  or the stimulation region  510 , and that function to position the stimulation region  510  away from the mounting regions  508  and closer to a target stimulation region. 
     One or more mounting apertures  518  are disposed on each of the mounting regions  508 . The one or more mounting apertures  518  are each configured and arranged for receiving a fastener (e.g., a bone screw, bolt, staples, sutures, or the like)  520 . In at least some embodiments, one or more adhesives may be used in addition to, or in lieu of, extending the fastener  520  through the one or more mounting aperture  518 . Any suitable number of mounting apertures  518  can be defined in the one or more mounting regions  508  including, for example, one, two, three, four, five, six, seven, eight, nine, ten, eleven, twelve, or more mounting apertures  518 . In  FIGS. 5A-5B  (and in other figures), a single mounting aperture  518  is defined in each of the mounting regions  508 . 
     In at least some embodiments, the mounting apertures  518  are positioned along the body such that the mounting apertures  518  align simultaneously with potential mounting surfaces of two different bony structures, such as two adjacent vertebrae  432 . In at least some embodiments, the spacing between a first mounting aperture of the plurality of mounting apertures  518  and a second mounting aperture of the plurality of mounting apertures  518  is equal to the spacing between two adjacent vertebrae  432  of the patient. 
     One or more electrodes, such as electrode  526 , are disposed on the orthopedic implant  504 . In at least some embodiments, the one or more electrodes  526  are disposed on the stimulation region of the orthopedic implant. In at least some embodiments, the one or more electrodes  526  are disposed along a bottom surface of the one or more stimulation regions such that the stimulation region is disposed between the electrodes  526  and the mounting regions  508 , thereby directing stimulation propagating from the electrodes  526  towards the target stimulation location. 
     Any suitable number of electrodes  526  can be disposed on the orthopedic implant including, for example, one, two, three, four, five, six, seven, eight, nine, ten, eleven, twelve, thirteen, fourteen, fifteen, sixteen, twenty, twenty-four, twenty-eight, thirty-two, forty, forty-eight, or more. In at least some embodiments, the one or more electrodes  526  extend outwardly from an outer surface of the orthopedic implant. In alternate embodiments, the one or more electrodes  526  are flush with, or inset from, the outer surface of the orthopedic implant. The one or more electrodes  526  can be formed in any suitable shape including, for example, round, oval, triangular, rectangular, or the like. It will be understood that the one or more electrodes  526  can be formed into other shapes, as well, either regular or irregular. 
     The one or more electrodes  526  are electrically coupled to the lead  502  via one or more conductors  528   a  disposed on or in the orthopedic implant. In at least some embodiments, the one or more conductors  528   a  are electrically coupled to one or more conductors  528   b  that are disposed along the body of the lead  502  and that electrically couple to the terminals disposed along the proximal end of the lead  502 . In at least some alternate embodiments, the control module may couple directly to the orthopedic implant  504 . In which case, the one or more conductors  528   a  electrically couple with conductors within the control module. 
     The one or more conductors  528   a  can be formed in any suitable manner including, for example, multi-filar conductive wires, single-filar conductive wires, conductive tracings, or the like. In at least some embodiments, the conductors  528   a  are formed along the body of the orthopedic implant as one or more conductive portions of the body. 
     In at least some embodiments, the body  506  of the orthopedic implant  504  is more rigid than the body of the lead  502 . In at least some embodiments, the body  506  of the orthopedic implant  504  is formed from a material that maintains its shape once the orthopedic implant  504  is implanted in the patient. The orthopedic implant  504  can be formed from any rigid material suitable for implantation including, for example, titanium, stainless steel, one or more alloys, composite material, or the like. 
     In at least some embodiments, the body  506  of the orthopedic implant  504  is formed from a non-conductive material. In at least some embodiments, the body  506  of the orthopedic implant  504  is formed from a conductive material and includes one or more non-conductive layers of material disposed over one or more portions of an outer surface of the conductive material of the orthopedic implant  504 . 
     The body  506  of the orthopedic implant  504  has a length  532  and a width  534 . In at least some embodiments, the width  534  of the body  506  is greater than a diameter of the body of the lead  502 . In at least some embodiments, the length  532  of the body  506  is smaller than a longitudinal length of the body of the lead  502 . In at least some embodiments, the length  532  of the body  506  is substantially smaller than a longitudinal length of the body of the lead  502 . 
     As shown in  FIG. 5A , in at least some embodiments the stimulation region  510  is longitudinally aligned with the opposing mounting regions  508  along the length  532  of the body  506 . As shown in  FIG. 5A , in at least some embodiments the width  534  of the body  506  is constant along the entire length  532  of the body  506 . 
     In  FIGS. 5A-5B , the lead  502  is shown coupled to the body  506  of the orthopedic implant  504  along one of the mounting regions  508 . In alternate embodiments, the lead  502  couples to the body  506  of the orthopedic implant  504  along the one or more stimulation regions  510 , or along the one or more transition regions  512 , or both. 
     In  FIG. 5B , the stimulation region  510  is shown as being recessed from the mounting regions  508 . When a particular DRG is the target stimulation location, it may be advantageous to form the stimulation region  510  as a recessed region of the body  606  to position the electrodes  526  closer to the DRG when the orthopedic implant  504  is mounted to two adjacent vertebrae  432  flanking the DRG. 
       FIG. 5C  is a schematic top view of one embodiment of the orthopedic implant  504  anchored to two adjacent vertebrae  432   a  and  432   b  disposed in proximity to a target stimulation region.  FIG. 5D  is a schematic side view of one embodiment of the orthopedic implant  504  anchored to two adjacent vertebrae  432   a  and  432   b  flanking the targeted DRG  420   a . The orthopedic implant  504  is mounted to the vertebrae  432   a  such that one of two fasteners  520  is passed through the mounting aperture of one of the two mounting regions  508  and into the vertebrae  432   a , while the other of the two fasteners  520  is passed through the mounting aperture of the other of the two mounting regions  508  and into the vertebrae  432   b.    
     In  FIG. 5D , the stimulation region  510  of the body  506  of the orthopedic implant  504  is shown recessed from the mounting regions  508  such that the electrodes  526  are positioned in proximity to the DRG  420   a . It will be understood that the orthopedic implant of  FIGS. 5A-5D  (as well as other orthopedic implants discussed herein) can be mounted to more than two vertebrae. It will also be understood that the orthopedic implant of  FIGS. 5A-5D  (as well as other orthopedic implants discussed herein) can be coupled to vertebrae that are not adjacent to one another. 
     In at least some embodiments, the one or more stimulation regions are longitudinally offset from the opposing mounting regions.  FIG. 6A  is a schematic bottom view of a second embodiment of the distal end of the body of the lead  502  coupled to an orthopedic implant  604 .  FIG. 6B  is a schematic side view of one embodiment of the distal end of the body of the lead  502  coupled to the orthopedic implant  604 . The orthopedic implant  604  includes an elongated body  606  with the mounting regions  508  disposed on opposing ends of the body  606  and a stimulation region  610  disposed therebetween. In at least some embodiments, the stimulation region  610  is disposed between the mounting regions  508  such that the stimulation region  610  is longitudinally offset from the opposing mounting regions  508 . 
     In  FIGS. 6A-6B , the mounting regions  508  are shown coupled to the stimulation region  610  via one or more transition regions  612 . In at least some embodiments, the mounting regions  508  are planar. In at least some embodiments, the stimulation region  610  is planar. In  FIGS. 6A-6B , the mounting regions  508  and the stimulation region  610  are shown as extending parallel to one another, while the transition region  612  is shown as a bent (or angled) region that is not parallel to either the mounting regions  508  or the stimulation region  610 , and that functions to position the stimulation region  610  away from the mounting regions  508  and closer to a target stimulation region. 
     One or more electrodes, such as electrode  526 , are disposed on the orthopedic implant  604 . In at least some embodiments, the one or more electrodes  526  are disposed on the stimulation region of the orthopedic implant. In at least some embodiments, the one or more electrodes  526  are disposed along a bottom surface of the one or more stimulation regions such that the stimulation region is disposed between the electrodes  526  and the mounting regions  508 , thereby directing stimulation propagating from the electrodes  526  towards the target stimulation region. 
     The one or more electrodes  526  are electrically coupled to the lead  502  via one or more conductors  528   a  disposed on or in the orthopedic implant. In at least some embodiments, the one or more conductors  528   a  are electrically coupled to one or more conductors  528   b  that are disposed along the body of the lead  502  and that electrically couple to the terminals disposed along the proximal end of the lead  502 . In at least some alternate embodiments, the control module may couple directly to the orthopedic implant  504 . In which case, the one or more conductors  528   a  electrically couple with conductors within the control module. 
     The one or more conductors  528   a  can be formed in any suitable manner including, for example, multi-filar conductive wires, single-filar conductive wires, conductive tracings, or the like. In at least some embodiments, the conductors  528   a  are formed along the body of the orthopedic implant as one or more conductive portions of the body. 
     In at least some embodiments, the body  606  of the orthopedic implant  604  is more rigid than the body of the lead  502 . In at least some embodiments, the body  606  of the orthopedic implant  604  is formed from a material that maintains its shape once the orthopedic implant  604  is implanted in the patient. The orthopedic implant  604  can be formed from any rigid material suitable for implantation including, for example, titanium, stainless steel, one or more alloys, composite material, or the like. In at least some embodiments, the body  606  of the orthopedic implant  604  is formed from a non-conductive material. In at least some embodiments, the body  606  of the orthopedic implant  604  is formed from a conductive material and includes one or more non-conductive layers of material disposed over one or more portions of an outer surface of the conductive material of the orthopedic implant  604 . 
     The body  606  of the orthopedic implant  604  has a length  632  and a width  634 . In at least some embodiments, the width  634  of the body  606  is greater than a diameter of the body of the lead  502 . In at least some embodiments, the length  632  of the body  606  is smaller than a longitudinal length of the body of the lead  502 . As shown in  FIG. 6A , in at least some embodiments the stimulation region  610  is longitudinally offset from the mounting regions  508 . In at least some embodiments, the stimulation region  610  or the one or more transition regions  612  extend from a side surface one (or both) of the mounting regions  508 . 
     In  FIG. 6B , the stimulation region  610  is shown as being recessed from the mounting region  508 . When a particular DRG is the target stimulation location, it may be advantageous to form the stimulation region  610  as a recessed region of the body  606  to position the electrodes  526  closer to the DRG when the orthopedic implant  604  is mounted to two adjacent vertebrae  432  flanking the DRG. 
       FIG. 6C  is a schematic top view of one embodiment of the orthopedic implant  604  anchored to two adjacent vertebrae  432   a  and  432   b  disposed in proximity to a target stimulation region.  FIG. 6D  is a schematic side view of one embodiment of the orthopedic implant  604  anchored to two adjacent vertebrae  432   a  and  432   b  flanking the targeted DRG  420   a . The orthopedic implant  604  is mounted to the vertebrae  432   a  such that one of two fasteners  520  is passed through the mounting aperture of one of the two mounting regions  508  and into the vertebrae  432   a , while the other of the two fasteners  520  is passed through the mounting aperture of the other of the two mounting regions  508  and into the vertebrae  432   b.    
     In  FIG. 6D , the stimulation region  610  of the body  606  of the orthopedic implant  604  is shown recessed from the mounting region  508  such that the electrodes  526  are positioned in proximity to the DRG  420   a . It will be understood that the orthopedic implant of  FIGS. 6A-6D  (as well as other orthopedic implants discussed herein) can be mounted to more than two vertebrae. It will also be understood that the orthopedic implant of  FIGS. 6A-6D  (as well as other orthopedic implants discussed herein) can be coupled to vertebrae that are not adjacent to one another. 
     In at least some embodiments, the one or more stimulation regions are arc-shaped.  FIG. 7A  is a schematic bottom view of a third embodiment of a distal end of the body of the lead  502  coupled to an orthopedic implant  704 .  FIG. 7B  is a schematic side view of one embodiment of the distal end of the body of the lead  502  coupled to the orthopedic implant  704 . 
     The orthopedic implant  704  includes an elongated body  706  with the mounting regions  508  disposed on opposing ends of the body  706  and a stimulation region  710  disposed therebetween. In at least some embodiments, the stimulation region  710  is disposed between the mounting regions  508  such that the stimulation region  710  is longitudinally offset from the opposing mounting regions  508 . 
     In  FIGS. 7A-7B , the mounting regions  508  are shown coupled to the stimulation region  710  via one or more transition regions  712 . In at least some embodiments, the mounting regions  508  are planar. In  FIGS. 7A-7B , the stimulation region  710  is shown as being arc-shaped, such that the target stimulation region can be disposed within the arc formed by the stimulation region  710 . In at least some embodiments, the transition region  712  is a bent (or angled) region that functions to position the stimulation region  710  away from the mounting regions  508  and closer to a target stimulation location. 
     One or more electrodes, such as electrode  526 , are disposed on the orthopedic implant  704 . In at least some embodiments, the one or more electrodes  526  are disposed on the stimulation region of the orthopedic implant. In at least some embodiments, the one or more electrodes  526  are disposed along a bottom surface of the stimulation region (e.g., on an inner surface of the arc formed by the stimulation region) such that the stimulation region is disposed between the electrodes  526  and the mounting regions  508 , thereby directing stimulation propagating from the electrodes  526  towards the target stimulation location. 
     The one or more electrodes  526  are electrically coupled to the lead  502  via one or more conductors  528   a  disposed on or in the orthopedic implant. In at least some embodiments, the one or more conductors  528   a  are electrically coupled to one or more conductors  528   b  that are disposed along the body of the lead  502  and that electrically couple to the terminals disposed along the proximal end of the lead  502 . In at least some alternate embodiments, the control module may couple directly to the orthopedic implant  504 . In which case, the one or more conductors  528   a  electrically couple with conductors within the control module. 
     In at least some embodiments, the body  706  of the orthopedic implant  704  is more rigid than the body of the lead  502 . In at least some embodiments, the body  706  of the orthopedic implant  704  is formed from a material that maintains its shape once the orthopedic implant  704  is implanted in the patient. The orthopedic implant  704  can be formed from any rigid material suitable for implantation including, for example, titanium, stainless steel, one or more alloys, composite material, or the like. In at least some embodiments, the body  706  of the orthopedic implant  704  is formed from a non-conductive material. In at least some embodiments, the body  706  of the orthopedic implant  704  is formed from a conductive material and includes one or more non-conductive layers of material disposed over at least one or more portions of an outer surface of the conductive material of the orthopedic implant  704 . 
     The body  706  of the orthopedic implant  704  has a length  732  and a width  734 . In at least some embodiments, the width  734  of the body  706  is greater than a diameter of the body of the lead  502 . In at least some embodiments, the length  732  of the body  706  is smaller than a longitudinal length of the body of the lead  502 . As shown in  FIG. 7A , in at least some embodiments the stimulation region  710  longitudinally offset from the mounting regions  508 . In at least some embodiments, the stimulation region  710  or the one or more transition regions  712  extend from a side surface one (or both) of the mounting regions  508 . 
     In  FIG. 7B , the stimulation region  710  is shown as being recessed from the mounting region  508 . When a particular DRG is the target stimulation location, it may be advantageous to form the stimulation region  710  as a recessed region of the body  706  to position the electrodes  526  closer to the DRG when the orthopedic implant  704  is mounted to two adjacent vertebrae  432  flanking the DRG. 
       FIG. 7C  is a schematic top view of one embodiment of the orthopedic implant  704  anchored to two adjacent vertebrae  432   a  and  432   b  disposed in proximity to a target stimulation region.  FIG. 7D  is a schematic side view of one embodiment of the orthopedic implant  704  anchored to two adjacent vertebrae  432   a  and  432   b  flanking the targeted DRG  420   a . The orthopedic implant  704  is mounted to the vertebrae  432   a  such that one of two fasteners  520  is passed through the mounting aperture of one of the two mounting regions  508  and into the vertebrae  432   a , while the other of the two fasteners  520  is passed through the mounting aperture of the other of the two mounting regions  508  and into the vertebrae  432   b.    
     In  FIG. 7D , the stimulation region  710  of the body  706  of the orthopedic implant  704  is shown recessed from the mounting region  508  such that the electrodes  526  are positioned in proximity to the DRG  420   a . It will be understood that the orthopedic implant of  FIGS. 7A-7D  (as well as other orthopedic implants discussed herein) can be mounted to more than two vertebrae. It will also be understood that the orthopedic implant of  FIGS. 7A-7D  (as well as other orthopedic implants discussed herein) can be coupled to vertebrae that are not adjacent to one another. 
     In at least some embodiments, the orthopedic implant is configured and arranged to mount to a single bony structure.  FIG. 8A  is a schematic side view of a fourth embodiment of a distal end of a body of the lead  502  coupled to an orthopedic implant  804 . In at least some embodiments, the orthopedic implant  804  is formed as an elongated enhanced fastener (e.g., a bone screw, bolt, staple, or the like)  820 . The enhanced fastener  820  includes a head  840  and a shaft  842  coupled to the head  840  at one end of the shaft  842 . The shaft  842  has a length  832  and includes a tip  844  opposite to the head  840 . The tip  844  is configured and arranged to penetrate a bony structure. In at least some embodiments, the enhanced fastener  804  includes one or more threads  846  extending along the shaft  842 . The one or more threads  846  may facilitate penetration of the bony structure, or anchoring of the enhanced fastener  804  to the bony structure, or both. 
     One or more electrodes  526  are disposed along the shaft  842  in proximity to the tip  844  of the enhanced fastener  820 . Alternately, the tip  844  itself may be formed as an electrode. The one or more electrodes  526  are electrically coupled to the lead  502  via one or more conductors  528   a  disposed on or in the orthopedic implant. In at least some embodiments, the one or more conductors  528   a  are electrically coupled to one or more conductors  528   b  that are disposed along the body of the lead  502  and that electrically couple to the terminals disposed along the proximal end of the lead  502 . In at least some alternate embodiments, the control module may couple directly to the orthopedic implant  504 . In which case, the one or more conductors  528   a  electrically couple with conductors within the control module. 
     In at least some embodiments, the length  832  of the shaft  842  is greater than a thickness of the bony structure to which the enhanced fastener  804  is configured to anchor. In which case, the enhanced fastener  804  may be configured and arranged for extending completely through the bony structure when the enhanced fastener  804  is anchored to the bony structure such that the tip  844  of the enhanced fastener  804  extends outwardly from a surface of the bony structure. 
       FIG. 8B  is a schematic side view of one embodiment of the orthopedic implant  804  anchored to the vertebra  432   a  such that the shaft  842  extends completely through the vertebrae  432   a  with the tip  844  extending outwardly from a surface of the vertebra  432   a  that is opposite from the head  840 . In  FIG. 8B , the one or more electrodes  526  are disposed along the tip  844  and are positioned in proximity to the DRG  420   a . In at least some embodiments, the one or more electrodes  526  are configured and arranged for coupling to the tip  844  after the enhanced fastener  804  is anchored to the bony structure and extended therethrough. In which case, the one or more electrodes  804  can be either removably or permanently coupled to the tip  844  using any suitable technique (e.g., adhesive, screw, bolt, snap, sutures, interference fit, or the like or combinations thereof). 
     As shown in  FIG. 8B , in at least some embodiments when the enhanced fastener  804  is anchored to the bony structure the head  840  of the enhanced fastener  804  extends from a first surface of the bony structure while the tip  844  extends outwardly from a second surface of the bony structure, opposite to the first surface. Alternately, in at least some embodiments when the enhanced fastener  804  is fastened to the bony structure the head  840  of the enhanced fastener  804  is flush with, or inset from, the first surface of the bony structure while the tip  844  extends outwardly from the second surface of the bony structure. 
     In at least some embodiments, the one or more electrodes  526  are bendable.  FIG. 8C  is a schematic side view of another embodiment of the orthopedic implant  804  anchored to one of the vertebrae  432   a .  FIG. 8D  is a schematic top view of the embodiment of the orthopedic implant  804  shown in  FIG. 8C  anchored to one of the vertebrae  432   a . As shown in  FIGS. 8C and 8D , the one or more electrodes  526  are configured and arranged to bend. In which case, the one or more electrodes  526  can be bent so that the one or more electrodes  526  are disposed in proximity to the target stimulation region (e.g., the DRG, or the like)  420   a.    
     It may be advantageous for the one or more electrodes to be bendable so that the one or more electrodes  526  can be positioned more closely to the target stimulation region after the enhanced fastener  804  is anchored to the bony structure, thereby reducing the potential for undesirably stimulating non-targeted tissue in proximity to the target stimulation location. 
     In at least some embodiments, instead of disposing one or more electrodes along a body of the orthopedic implant (as shown and discussed with reference to  FIGS. 5A-8D ), the orthopedic implant is configured and arranged to retain one or more leads.  FIG. 9A  is a schematic top view of a fifth embodiment of an orthopedic implant  904  that includes an anchoring unit suitable for anchoring one or more leads to one or more of the vertebrae  432 .  FIG. 9B  is a schematic side view of one embodiment of the orthopedic implant  904 . In at least some embodiments, the orthopedic implant  904  is configured and arranged to anchor one or more leads to the orthopedic implant  904  such that electrodes disposed along the one or more leads can be positioned in proximity to a target stimulation location (e.g., a DRG, or the like). 
     The orthopedic implant  904  includes an elongated body  906  having one or more mounting regions  508  with mounting apertures  518  for mounting the orthopedic implant  904  to one or more bony structures. The orthopedic implant  904  also includes one or more lead anchoring regions  970  for anchoring the one or more leads to the orthopedic implant  904 . 
     In at least some embodiments, the one or more lead anchoring regions  970  are disposed between two or more mounting regions  508 . In at least some embodiments, the one or more lead anchoring regions  970  are disposed between the mounting regions  508  such that the one or more lead anchoring regions  970  are aligned along a longitudinal axis with the two or more mounting regions  508  disposed on opposing ends of the body  906 . In at least some other embodiments, the one or more lead anchoring regions  970  are longitudinally offset from the mounting regions  508 . In at least some embodiments, the body  906  additionally includes one or more transition regions coupling the one or more mounting regions  508  to the one or more lead anchoring regions  508 . 
     In at least some embodiments, the one or more lead anchoring regions  970  are recessed from the one or more mounting region  508 . When a particular DRG is the target stimulation location, it may be advantageous to form the one or more anchoring regions  970  as a recessed region of the body  906  in order to position the electrodes  526  closer to the DRG when the orthopedic implant  904  is mounted to two adjacent vertebrae  432  flanking the DRG. 
     In at least some embodiments, the body  906  of the orthopedic implant  904  is formed from a material that maintains its shape once the orthopedic implant  904  is implanted in the patient. The orthopedic implant  904  can be formed from any rigid material suitable for implantation including, for example, titanium, stainless steel, one or more alloys, composite material, or the like. In at least some embodiments, the body  906  of the orthopedic implant  904  is formed from a non-conductive material. In at least some embodiments, the body  906  of the orthopedic implant  904  is formed from a conductive material and includes one or more non-conductive layers of material disposed over at least one or more portions of an outer surface of the conductive material of the orthopedic implant  904 . 
     In at least some embodiments, the one or more lead anchoring regions  970  are configured and arranged to anchor one or more leads to the orthopedic implant  904  such that electrodes disposed on the one or more leads can be positioned in proximity to a target stimulation location (e.g., a DRG, or the like). 
     In at least some embodiments, the one or more lead anchoring regions  970  each includes one or more lead lumens  974 , where each of the one or more lead lumens  974  is configured and arranged to receive a portion of a lead. In at least some embodiments, the one or more lead anchoring regions  970  each includes one or more fastener lumens  976  that intersect with the one or more lead lumens  974  and that are configured and arranged to receive a fastener (e.g., a screw, pin, clamp, latch, lug, nail, bolt, dowel, rod, rivet, or the like or combinations thereof) for fastening against a portion of a lead when the lead is inserted into the lead lumen  974 . Examples of anchoring regions configured and arranged for receiving portions of leads are found in, for example, U.S. Patent Application Publication No. 2010/0274336; 2011/0178573; and 2012/0185027, all of which are incorporated by reference. 
     In at least some embodiments, the orthopedic implant  904  is configured and arranged to anchor one or more percutaneous leads (see e.g.,  FIG. 2 ) to the one or more bony structures.  FIG. 9C  is a schematic top view of one embodiment of distal ends of two percutaneous leads  980   a  and  980   b  extending through the lead lumens  974 . Each of the percutaneous leads  980   a  and  980   b  includes a plurality of terminals (see e.g., terminals  310  of  FIGS. 3A-3C ) disposed at proximal ends of the percutaneous leads  980   a  and  980   b . Fasteners  978  (e.g., screws, pins, clamps, latches, lugs, nails, bolts, dowels, rods, rivets, or the like or combinations thereof) are extended along the fastener lumens  976  and used to fasten the percutaneous leads  980   a  and  980   b  to the orthopedic implant  904 . 
     A plurality of electrodes, such as electrodes  982   a  and  982   b , are disposed along the distal ends of the percutaneous leads  980   a  and  980   b , respectively. As shown in  FIG. 9C , in at least some embodiments the one or more lead lumens  974  are configured and arranged to receive a portion of a distal end of the percutaneous leads  980   a  and  980   b . In at least some embodiments, the one or more lead lumens  974  are configured and arranged to receive a portion of the distal end of the percutaneous leads  980   a  and  980   b  proximal to the plurality of electrodes  982   a  and  982   b.    
     The electrodes  982   a  and  982   b  can be any suitable shape, such as ring-shaped, cuff-shaped, arc-shaped or segmented. Examples of leads with segmented electrodes include U.S. Pat. Nos. 8,295,944; and 8,391,985; U.S. Patent Application Publications Nos. 2010/0268298; 2011/0005069; 2011/0078900; 2011/0130817; 2011/0130818; 2011/0238129; 2011/0313500; 2012/0016378; 2012/0046710; 2012/0165911; 2012/0197375; 2012/0203316; 2012/0203320; 2012/0203321, all of which are incorporated herein by reference. It may be advantageous for the electrodes  982   a  and  982   b  to be shaped such that stimulation energy propagated from the electrodes  982   a  and  982   b  is directed primarily towards the target stimulation location. For example, it may be advantageous to form the electrodes  982   a  and  982   b  such that they do not extend completely around the circumference of the body of the percutaneous leads  980   a  and  980   b.    
     In at least some embodiments that use directional electrodes, the proximal ends of the bodies of the percutaneous leads  980   a  and  980   b  include markers identifying the directionality of the electrodes  982   a  and  982   b . The markers may be used to facilitate implantation by enabling a practitioner to be able to recognize the orientation of the electrodes in the implanted leads by visually inspecting the markers disposed at the proximal ends of the leads. 
       FIG. 9D  is a schematic top view of one embodiment of the orthopedic implant  904  anchored to two of the vertebrae  432   a  and  432   b  by fasteners  520 . Two percutaneous leads  980   a  and  980   b  are fastened to the orthopedic implant  904  such that the electrodes  982   a  and  982   b  of the percutaneous leads  980   a  and  980   b , respectively, are disposed in proximity to the DRG  420   a . It will be understood that the orthopedic implant can be anchored to the one or more bony structures either before or after the one or more leads are fastened to the orthopedic implant. 
     In at least some embodiments, the orthopedic implant  904  is configured and arranged to anchor one or more paddle leads (see e.g.,  FIG. 1 ) to the one or more bony structures.  FIG. 9E  is a schematic top view of one embodiment of a paddle lead  990  fastened to the orthopedic implant  904 . The paddle lead  990  includes a paddle body  992  and a plurality of lead bodies  994  coupled to the paddle body  992 . A plurality of electrodes, including electrode  996 , are disposed on the paddle body  992 . 
     Each of the lead bodies  994  includes a plurality of terminals (see e.g., terminals  310  of  FIGS. 3A-3C ) disposed at proximal ends of the lead bodies  994 . The lead bodies  994  of the paddle lead  990  are shown in  FIG. 9E  extending through the lead lumens  974  and fastened to the orthopedic implant  904  by fasteners  978  extended along the fastener lumens  976 . 
     In  FIG. 9E , the electrodes  996  are shown disposed along a bottom surface of the paddle body  992 . It may be advantageous for the electrodes  996  to be oriented such that stimulation energy propagated from the electrodes  996  is directed towards the target stimulation location. For example, when the orthopedic implant  904  is anchored to a bony structure disposed above the target stimulation location, it may be advantageous to orient the lead(s) such that the electrodes face downward, towards the target stimulation location, such as is shown in  FIG. 9D . 
     In  FIGS. 9A-9E  the orthopedic implant  904  is shown with an elongated body  906  configured and arranged to mount to, and extend between, two bony structures. In at least some embodiments, the orthopedic implant  904  may be configured and arranged to mount to a single bony structure. For example, in at least some embodiments the one or more lead anchoring regions  970  are coupled to the enhanced fastener  804 . 
       FIG. 10  is a schematic overview of one embodiment of components of an electrical stimulation system  1000  including an electronic subassembly  1010  disposed within a control module. It will be understood that the electrical stimulation system can include more, fewer, or different components and can have a variety of different configurations including those configurations disclosed in the stimulator references cited herein. 
     Some of the components (for example, power source  1012 , antenna  1018 , receiver  1002 , and processor  1004 ) of the electrical stimulation system can be positioned on one or more circuit boards or similar carriers within a sealed housing of an implantable pulse generator, if desired. Any power source  1012  can be used including, for example, a battery such as a primary battery or a rechargeable battery. Examples of other power sources include super capacitors, nuclear or atomic batteries, mechanical resonators, infrared collectors, thermally-powered energy sources, flexural powered energy sources, bioenergy power sources, fuel cells, bioelectric cells, osmotic pressure pumps, and the like including the power sources described in U.S. Pat. No. 7,437,193, incorporated herein by reference. 
     As another alternative, power can be supplied by an external power source through inductive coupling via the optional antenna  1018  or a secondary antenna. The external power source can be in a device that is mounted on the skin of the user or in a unit that is provided near the user on a permanent or periodic basis. 
     If the power source  1012  is a rechargeable battery, the battery may be recharged using the optional antenna  1018 , if desired. Power can be provided to the battery for recharging by inductively coupling the battery through the antenna to a recharging unit  1016  external to the user. Examples of such arrangements can be found in the references identified above. 
     In one embodiment, electrical current is emitted by the electrodes  134  on the paddle or lead body to stimulate nerve fibers, muscle fibers, or other body tissues near the electrical stimulation system. A processor  1004  is generally included to control the timing and electrical characteristics of the electrical stimulation system. For example, the processor  1004  can, if desired, control one or more of the timing, frequency, strength, duration, and waveform of the pulses. In addition, the processor  1004  can select which electrodes can be used to provide stimulation, if desired. In some embodiments, the processor  1004  may select which electrode(s) are cathodes and which electrode(s) are anodes. In some embodiments, the processor  1004  may be used to identify which electrodes provide the most useful stimulation of the desired tissue. 
     Any processor can be used and can be as simple as an electronic device that, for example, produces pulses at a regular interval or the processor can be capable of receiving and interpreting instructions from an external programming unit  1008  that, for example, allows modification of pulse characteristics. In the illustrated embodiment, the processor  1004  is coupled to a receiver  1002  which, in turn, is coupled to the optional antenna  1018 . This allows the processor  1004  to receive instructions from an external source to, for example, direct the pulse characteristics and the selection of electrodes, if desired. 
     In one embodiment, the antenna  1018  is capable of receiving signals (e.g., RF signals) from an external telemetry unit  1006  which is programmed by a programming unit  1008 . The programming unit  1008  can be external to, or part of, the telemetry unit  1006 . The telemetry unit  1006  can be a device that is worn on the skin of the user or can be carried by the user and can have a form similar to a pager, cellular phone, or remote control, if desired. As another alternative, the telemetry unit  1006  may not be worn or carried by the user but may only be available at a home station or at a clinician&#39;s office. The programming unit  1008  can be any unit that can provide information to the telemetry unit  1006  for transmission to the electrical stimulation system  1000 . The programming unit  1008  can be part of the telemetry unit  1006  or can provide signals or information to the telemetry unit  1006  via a wireless or wired connection. One example of a suitable programming unit is a computer operated by the user or clinician to send signals to the telemetry unit  1006 . 
     The signals sent to the processor  1004  via the antenna  1018  and receiver  1002  can be used to modify or otherwise direct the operation of the electrical stimulation system. For example, the signals may be used to modify the pulses of the electrical stimulation system such as modifying one or more of pulse duration, pulse frequency, pulse waveform, and pulse strength. The signals may also direct the electrical stimulation system  1000  to cease operation, to start operation, to start charging the battery, or to stop charging the battery. In other embodiments, the stimulation system does not include an antenna  1018  or receiver  1002  and the processor  1004  operates as programmed. 
     Optionally, the electrical stimulation system  1000  may include a transmitter (not shown) coupled to the processor  1004  and the antenna  1018  for transmitting signals back to the telemetry unit  1006  or another unit capable of receiving the signals. For example, the electrical stimulation system  1000  may transmit signals indicating whether the electrical stimulation system  1000  is operating properly or not or indicating when the battery needs to be charged or the level of charge remaining in the battery. The processor  1004  may also be capable of transmitting information about the pulse characteristics so that a user or clinician can determine or verify the characteristics. 
     The above specification, examples and data provide a description of the manufacture and use of the composition of the invention. Since many embodiments of the invention can be made without departing from the spirit and scope of the invention, the invention also resides in the claims hereinafter appended.