Patent Publication Number: US-2015060136-A1

Title: Systems and methods for forming an end of an elongated member of an electrical stimulation system

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a divisional of U.S. patent application Ser. No. 12/473,170 filed May 27, 2009, which is 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 systems and methods of forming one or more ends of elongated members of 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 chronic pain syndrome and incontinence, with 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. 
     BRIEF SUMMARY 
     In one embodiment, a method for forming a lead or lead extension having an arrangement of a plurality of elongated conductors disposed in a body of the lead or lead extension, each of the elongated conductors extending from a proximal end of the arrangement to a distal end of the arrangement, includes ablating a plurality of spaced-apart channels in proximity to at least one of the proximal end or the distal end of the body to expose at least part of at least one of the plurality of elongated conductors. A C-shaped contact is disposed into each of a different one of the transverse channels. Each of the C-shaped contacts is electrically coupled to at least one of the elongated conductors. Each of the C-shaped contacts is closed so that opposing ends of the C-shaped contact are adjacent to one another and aligned over one of the elongated conductors. For each of the C-shaped contacts, the two opposing ends are coupled together such that the C-shaped contact forms a continuous path around the arrangement within the transverse channel in which the C-shaped contact is disposed. 
     In another embodiment, a method for forming a lead or lead having an arrangement of a plurality of elongated conductors disposed in a body of the lead or lead extension, each of the elongated conductors extending from a proximal end of the arrangement to a distal end of the arrangement, includes ablating a plurality of access ports in at least one of the proximal end or the distal end of the body, each of the access ports exposing one of the elongated conductors. C-shaped contacts are disposed over each of the access ports such that each C-shaped contact is disposed over at least one of the access ports. The C-shaped contacts are electrically coupled to at least one of the elongated conductors. Each of the C-shaped contacts is closed so that the two opposing ends of the C-shaped contacts are adjacent to one another. For each of the C-shaped contacts, the two opposing ends are coupled together such that the C-shaped contact forms a continuous path around the arrangement over the at least one access port over which the C-shaped contact is disposed. 
     In yet another embodiment, a lead includes a lead body with an outer layer and having a distal end, a proximal end, and a transverse circumference. The lead body defines a plurality of spaced-apart channels around the transverse circumference of the lead body in proximity to at least one of the distal end or the proximal end of the lead body. The lead body includes a plurality of cylindrical electrodes disposed on the distal end of the lead body, a plurality of cylindrical terminals disposed on the proximal end of the lead body, and a plurality of conductors, each conductor electrically coupling at least one of the electrodes to at least one of the terminals. At least one of the plurality of electrodes or at least one of the plurality of terminals includes a C-shaped contact that has been disposed over the transverse circumference of the lead body and closed with opposing ends of the C-shaped contact coupled together. The opposing ends of the C-shaped contact define a coupling aperture. At least one of the plurality of conductors extends into the coupling aperture and electrically couples to the C-shaped contact. 
    
    
     
       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, according to the invention; 
         FIG. 2  is a schematic view of another embodiment of an electrical stimulation system, according to the invention; 
         FIG. 3A  is a schematic view of one embodiment of a proximal portion of a lead and a control module of an electrical stimulation system, according to the invention; 
         FIG. 3B  is a schematic view of one embodiment of a proximal portion of a lead and a lead extension of an electrical stimulation system, according to the invention; 
         FIG. 4  is a schematic perspective view of one embodiment of a proximal end of an elongated member, according to the invention; 
         FIG. 5  is a schematic perspective view of one embodiment of a proximal end of an elongated member and a C-shaped contact, the elongated member having transverse channels ablated into the elongated member to expose conductors extending within the elongated member, according to the invention; 
         FIG. 6  is a schematic perspective view of one embodiment of the C-shaped contact of  FIG. 5  disposed over a transverse channel ablated into the elongated member of  FIG. 5 , according to the invention; 
         FIG. 7  is a schematic perspective view of one embodiment of the C-shaped contact of  FIG. 5  disposed over a transverse channel ablated into the elongated member of  FIG. 5  with opposing inwardly-bending ends of the C-shaped contact coupled together to form a continuous path around the transverse channel, according to the invention; and 
         FIG. 8  is a schematic overview of one embodiment of components of a stimulation system, including an electronic subassembly disposed within a control module, 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 systems and methods of forming one or more ends of elongated members of 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, 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; and 6,741,892; and U.S. patent application Ser. Nos. 10/353,101, 10/503,281, 11/238,240; 11/319,291; 11/327,880; 11/375,638; 11/393,991; and 11/396,309, 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 , a paddle body  104 , and at least one lead body  106  coupling the control module  102  to the paddle body  104 . The paddle body  104  and the one or more lead bodies  106  form a lead. The paddle body  104  typically includes an array of electrodes  134 . The control module  102  typically includes an electronic subassembly  110  and an optional power source  120  disposed in a sealed housing  114 . The control module  102  typically includes a connector  144  ( FIGS. 2 and 3A , see also  322  and  350  of  FIG. 3B ) into which the proximal end of the one or more lead bodies  106  can be plugged to make an electrical connection via connector contacts on the control module  102  and terminals (e.g.,  310  in  FIG. 3A and 336  of  FIG. 3B ) on each of the one or more lead bodies  106 . 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 the lead body  106  forming a percutaneous lead, as illustrated in  FIG. 2 . A percutaneous lead may be isodiametric along the length of the lead. In addition, one or more lead extensions  312  (see  FIG. 3B ) 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  of the embodiments shown in  FIGS. 1 and 2 . 
     The electrical stimulation system or components of the electrical stimulation system, including one or more of the lead bodies  106 , the paddle body  104 , and the control module  102 , 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, brain stimulation, neural stimulation, spinal cord stimulation, muscle stimulation, 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. The number of electrodes  134  in the array of electrodes  134  may vary. For example, there can be two, four, six, eight, ten, twelve, fourteen, sixteen, or more electrodes  134 . As will be recognized, other numbers of electrodes  134  may also be used. 
     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, polyetheretherketone (“PEEK”), epoxy, 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 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 and 336  of  FIG. 3B ) are typically disposed at the proximal end of the one or more lead bodies  106  for connection to corresponding connector contacts (e.g.,  314  in  FIG. 3A and 340  of  FIG. 3B ) in connectors (e.g.,  144  in  FIGS. 1-3A  and  322  and  350  of  FIG. 3B ) disposed on, for example, the control module  102  (or to other devices, such as connector contacts on a lead extension, an operating room cable, or an adaptor). Conductive wires (“conductors”) (not shown) extend from the terminals (e.g.,  310  in  FIG. 3A and 336  of  FIG. 3B ) to the electrodes  134 . Typically, one or more electrodes  134  are electrically coupled to a terminal (e.g.,  310  in  FIG. 3A and 336  of  FIG. 3B ). In some embodiments, each terminal (e.g.,  310  in  FIG. 3A and 336  of  FIG. 3B ) is only connected 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 . In at least one embodiment, the one or more lumens may be flushed continually, or on a regular basis, with saline, epidural fluid, or the like. In at least some embodiments, the one or more lumens can be permanently or removably sealable at the distal end. 
     In at least some embodiments, leads are coupled to connectors disposed on control modules. In  FIG. 3A , a lead  308  is shown configured and arranged for insertion to the control module  102 . The connector  144  includes a connector housing  302 . The connector housing  302  defines at least one port  304  into which a proximal end  306  of a lead  308  with terminals  310  can be inserted, as shown by directional arrow  312 . The connector housing  302  also includes a plurality of connector contacts  314  for each port  304 . When the lead  308  is inserted into the port  304 , the connector contacts  314  can be aligned with the terminals  310  on the lead  308  to electrically couple the control module  102  to the electrodes ( 134  of  FIG. 1 ) disposed at a distal end of the lead  308 . Examples of connectors in control modules are found in, for example, U.S. Pat. No. 7,244,150 and U.S. patent application Ser. No. 11/532,844, which are incorporated by reference. 
     In  FIG. 3B , a connector  322  is disposed on a lead extension  324 . The connector  322  is shown disposed at a distal end  326  of the lead extension  324 . The connector  322  includes a connector housing  328 . The connector housing  328  defines at least one port  330  into which a proximal end  332  of a lead  334  with terminals  336  can be inserted, as shown by directional arrow  338 . The connector housing  328  also includes a plurality of connector contacts  340 . When the lead  334  is inserted into the port  330 , the connector contacts  340  disposed in the connector housing  328  can be aligned with the terminals  336  on the lead  334  to electrically couple the lead extension  324  to the electrodes ( 134  of  FIG. 1 ) disposed at a distal end (not shown) of the lead  334 . 
     In at least some embodiments, the proximal end of a lead extension is similarly configured and arranged as a proximal end of a lead. The lead extension  324  may include a plurality of conductive wires (not shown) disposed in a body of the lead extension that electrically couple the connector contacts  340  to a proximal end  348  of the lead extension  324  that is opposite to the distal end  326 . In at least some embodiments, 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 connector disposed in another lead extension. In other embodiments, the proximal end  348  of the lead extension  324  is configured and arranged for insertion into a connector disposed in a control module. As an example, in  FIG. 3B  the proximal end  348  of the lead extension  324  is inserted into a connector  350  disposed in a control module  352 . 
     Assembling the ends of an elongated member (e.g., a lead, a lead extension, or the like) may be complex, tedious, and expensive. For example, with conventional methods, the proximal end of the body of the elongated member is typically radially ablated to expose underlying conductors extending within the body of the elongated member. Cylindrical contacts (e.g., terminals) are placed over the exposed conductors in a spaced-apart manner with one or more non-conductive spacers positioned between adjacent contacts. Each of the contacts is electrically coupled to a different one of the conductors. Additional steps may also be necessary including, for example, back filling lumens in which the conductors are disposed with epoxy and grinding the contacts to size so that outer surfaces of the contacts are flush with outer surfaces of the elongated body. In some cases (e.g., with percutaneous leads), the distal end of the elongated members may be assembled in a similar manner, with the contacts being electrodes instead of terminals. In other cases (e.g., with lead extensions), the distal end of the elongated members may be assembled in a similar manner, with the contacts being connector contacts instead of terminals. 
     In at least some embodiments, a plurality of spaced-apart C-shaped contacts may be disposed over portions of the elongated member and electrically coupled to underlying conductors extending within the elongated member. In at least some embodiments, each of the C-shaped contacts has opposing inwardly-bending ends that wrap around a transverse axis of the elongated member and that may be closed and coupled together to form a continuous path around the transverse axis of the elongated member. In at least some embodiments, portions of the elongated member may be ablated to form spaced-apart transverse channels that are configured and arranged to receive C-shaped contacts and that provide access to electrically couple the C-shaped contacts to the underlying conductors. 
     Typically, the elongated member includes an arrangement of elongated conductors disposed in an outer layer. The conductors may be disposed in elongated members in many different possible configurations (e.g., arranged into units, coiled into a helical configuration, disposed in a multi-lumen retention element, disposed over a sleeve, disposed over a mandrel, or the like). Additionally, in at least some embodiments, the conductors are also individually encased by a layer of insulation. It will be understood that, when the conductors are individually encased by a layer of insulation, the layer of insulation encasing the conductor may also be ablated to expose underlying conductors. 
     In at least some embodiments, the conductors are disposed in a multi-lumen retention element.  FIG. 4  is a schematic perspective view of one embodiment of an elongated member  402 . The elongated member  402  includes a body  404 . The body  404  includes a multi-lumen retention element  406  and an outer layer  408 . In at least some embodiments, the outer layer  408  is part of the multi-lumen retention element  406 . One or more conductors, such as conductor  410 , may be disposed in one or more of the lumens, such as lumen  412 . It will be understood that the conductor  410  is shown extending from the elongated member  402  for clarity of illustration. 
     To electrically couple the conductors to contacts, the conductors are exposed. One technique for exposing the conductors is ablating portions of the outer layer  408  of the elongated member  402 . In at least some embodiments, the outer layer  406  of the elongated member  402  is ablated to form spaced-apart transverse channels to access a plurality of the conductors and also to receive a C-shaped contact. In preferred embodiments, the transverse channels are laser ablated. 
       FIG. 5  is a schematic perspective view of one embodiment of the elongated member  402  and a C-shaped contact  502 . The outer layer  408  of the elongated member  402  has been ablated to form transverse channels  504 - 506  extending along a transverse axis of the elongated member. The transverse channels  504 - 506  are deep enough to expose a plurality of underlying conductors when conductors are disposed in the elongated member  402 . It will be understood that, when conductors are disposed in the lumens of the multi-lumen retention element  406 , an outer portion of the multi-lumen retention element  404  may also be ablated to expose the conductors. In some embodiments, the outer portion of the multi-lumen retention element  404  is ablated before the conductors are disposed in the multi-lumen retention element  404 . In other embodiments, the outer portion of the multi-lumen retention element  404  is ablated after the conductors are disposed in the multi-lumen retention element  404 . 
     The C-shaped contact  502  includes two opposing inwardly-bending ends  508  and  510 . In at least some embodiments, each of the opposing ends define a portion of a coupling aperture  512   a  and  512   b,  respectively, which collectively form a coupling aperture ( 512  in  FIG. 7 ) when the C-shaped contact  502  is closed, as described below. 
     The C-shaped contact  502  may be formed from any biocompatible conductive material suitable for implantation into a patient including, for example, metals (e.g., platinum, iridium, and the like), alloys, conductive polymers, conductive carbon, and the like, as well as combinations thereof. 
     In at least some embodiments, the C-shaped contact  502  defines a transverse length between the opposing inwardly-bending ends  508  and  510 . In some embodiments, the transverse length of the C-shaped contact  502  is equal to a transverse circumference of the ablated portion of the transverse channels  504 - 506  of the elongated body  402 . In other embodiments, the transverse length of the C-shaped contact  502  is equal to a transverse circumference of the outer layer of the elongated body  402 . In some embodiments, the C-shaped contact  502  is configured and arranged to be disposed in the transverse channels  504 - 506  (as described below and as shown in  FIGS. 6 and 7 ). In other embodiments, the C-shaped contact  502  is configured and arranged to be disposed over the outer layer  408  of the elongated member  402 . 
     It may be an advantage for an elongated member to be isodiametric. An isodiametric elongated member may reduce the chance of the elongated member getting caught on patient tissue during insertion of the elongated member into the patient, or during patient movement subsequent to implantation of the elongated member. 
     It may be an advantage to inset the C-shaped contact  502  in the transverse channel  504  because the C-shaped contact  502  may be formed with a transverse cross-sectional profile that is thicker than with conventional contacts, when the elongated member is isodiametric. A thicker contact may promote better electrical contact and may increase durability of the electrical stimulation system. It may further be an advantage to inset the C-shaped contact  502  in the transverse channel  504  because the thickness of the transverse cross-sectional profile of the C-shaped contact  502  may be formed so that an outer surface of the C-shaped contact  502  is flush with the outer layer  408  of the elongated member without needing to grind down the C-shaped contact  502 . 
     In other embodiments, there can be grinding of the lead (e.g., the contacts, the lead body, or both) to form an isodiametric lead. 
       FIG. 6  is a schematic perspective view of one embodiment of the C-shaped contact  502  disposed in the transverse channel  504  of the elongated member  402 . In at least some embodiments, the C-shaped contact  502  is flexible. In at least some embodiments, the C-shaped contact  502  is disposed within the transverse channel  504 . For example, in at least some embodiments the C-shaped contact  502  is snapped over the transverse channel  504 . In at least some embodiments, the depth of the transverse channel  504  is no greater than the thickness of the C-shaped contact  502 . In at least some embodiments, the depth of the transverse channel  504  is equal to the thickness of the C-shaped contact  502 . 
     Accordingly, in at least some embodiments, when the C-shaped contacts are disposed in the transverse channels, an outer surface of the C-shaped contact  502  is flush with outer surfaces of the elongated member  402 . Alternatively, in at least some other embodiments, the outer surfaces of the C-shaped contact  502  extend radially outward from the outer surfaces of the elongated member  402 . In which case, the outer surfaces of the C-shaped contact  502  may be ground down to be flush with the outer surfaces of the elongated member  402 . 
     In at least some embodiments, once the C-shaped contact  502  is disposed over one of the transverse channels, the C-shaped contact  502  is closed (e.g., crimped, clamped, squeezed, or the like) so that the opposing inwardly-bending ends  508  and  510  of the C-shaped contact  502  are adjacent to one another.  FIG. 7  is a schematic perspective view of one embodiment of the C-shaped contact  502  disposed over the transverse channel  504  of the elongated member  402 . The opposing ends  508  and  510  of the C-shaped contact  502  are closed so that the opposing inwardly-bending ends  508  and  510  are adjacent to one another. In at least some embodiments, a tooling fixture may be used to close the C-shaped contact  502 . In at least some embodiments, when the opposing ends  508  and  510  are closed, the portions of the coupling aperture ( 512   a  and  512   b  of  FIG. 5 ) align to form a complete coupling aperture  512 . 
     Once the C-shaped contact  502  is closed, the opposing ends  508  and  510  of the C-shaped contact  502  may be coupled together to form a continuous path around a transverse circumference of the elongated member  402 . In preferred embodiments, the opposing ends  508  and  510  are coupled together using an electrically-conductive medium (e.g., welding, soldering, or the like). 
     In at least some embodiments, the closed opposing ends  508  and  510  of the C-shaped contact  502  may be aligned around the transverse circumference of the elongated member  402  such that the coupling aperture  512  aligns with one of the conductors. In at least some embodiments, when the coupling aperture  512  is aligned with one of the conductors, electrically coupling the opposing ends  508  and  510  of the C-shaped contact  502  together also electrically couples the aligned conductor to the C-shaped contact  502 , via the coupling aperture  512 . For example, the aligned conductor may be extended through the coupling aperture  512  so that coupling the opposing ends  508  and  510  of the C-shaped contact  502  also couples the conductor to the C-shaped contact  502 . It will be understood that, when multiple C-shaped contacts are coupled to the elongated member  402 , each of the coupling apertures of different C-shaped contacts may be aligned with different conductors. 
     In alternate embodiments, one of the underlying conductors may be electrically coupled to the C-shaped contact  502  prior to the C-shaped contacts being closed. For example, the C-shaped contact  502  may be disposed within the transverse channel  504  in an open position and one of the underlying conductors accessible from one of the transverse channels  504  may be coupled to an undersurface of the C-shaped contact  502 , or coupled to one of the opposing ends (preferably within a portion of one of the coupling apertures) of the C-shaped contact  502 . The C-shaped contact  502  may subsequently be closed and the ends of the C-shaped contact  502  may be coupled together. In at least some embodiments, coupling the C-shaped contact  502  is performed by an automated system. It may be an advantage to employ an automated system to increase one or more of productivity or consistency. 
     In at least some other embodiments, one or more access holes may by ablated in the elongated body in addition to, or in lieu of, ablating one or more transverse channels. One or more access holes may be ablated through the outer layer  406  to access one of the conductors individually, without accessing multiple conductors. It may be an advantage to ablate individual access holes instead of ablating transverse channels to prevent undesired conductors from contacting the C-shaped contact and potentially causing a short circuit. 
     When one or more access holes are ablated in the elongated body, the C-shaped contact  502  may be disposed over the outer layer  408  of the elongated body and the C-shaped contact  502  may be electrically coupled to the underlying conductor via the one or more access holes. In some embodiments, the C-shaped contact  502  is electrically coupled to the underlying conductor prior to coupling the C-shaped contact  502 , in a similar manner as describe above. In other embodiments, the C-shaped contact  502  is closed without being electrically coupled to the conductors. Then, once the C-shaped contact  502  is closed, the coupling aperture  512  of the C-shaped contact  502  is aligned over at least one of the access holes and the C-shaped contact  502  is electrically coupled to the underlying conductor, via the coupling aperture  512 , as the opposing ends  508  and  510  of the C-shaped contact  502  are coupled together. In at least some embodiments, the underlying conductor is extended through the coupling aperture  512  when the opposing ends  508  and  510  of the C-shaped contact  502  are coupled together. 
       FIG. 8  is a schematic overview of one embodiment of components of an electrical stimulation system  800  including an electronic subassembly  810  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  812 , antenna  818 , receiver  802 , and processor  804 ) 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  812  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. Patent Application Publication No. 2004/0059392, incorporated herein by reference. 
     As another alternative, power can be supplied by an external power source through inductive coupling via the optional antenna  818  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  812  is a rechargeable battery, the battery may be recharged using the optional antenna  818 , if desired. Power can be provided to the battery for recharging by inductively coupling the battery through the antenna to a recharging unit  816  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  804  is generally included to control the timing and electrical characteristics of the electrical stimulation system. For example, the processor  804  can, if desired, control one or more of the timing, frequency, strength, duration, and waveform of the pulses. In addition, the processor  804  can select which electrodes can be used to provide stimulation, if desired. In some embodiments, the processor  804  may select which electrode(s) are cathodes and which electrode(s) are anodes. In some embodiments, the processor  804  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  808  that, for example, allows modification of pulse characteristics. In the illustrated embodiment, the processor  804  is coupled to a receiver  802  which, in turn, is coupled to the optional antenna  818 . This allows the processor  804  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  818  is capable of receiving signals (e.g., RF signals) from an external telemetry unit  806  which is programmed by a programming unit  808 . The programming unit  808  can be external to, or part of, the telemetry unit  1506 . The telemetry unit  1506  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  806  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  808  can be any unit that can provide information to the telemetry unit  806  for transmission to the electrical stimulation system  800 . The programming unit  808  can be part of the telemetry unit  806  or can provide signals or information to the telemetry unit  806  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  806 . 
     The signals sent to the processor  804  via the antenna  818  and receiver  802  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  800  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  818  or receiver  802  and the processor  804  operates as programmed. 
     Optionally, the electrical stimulation system  800  may include a transmitter (not shown) coupled to the processor  804  and the antenna  818  for transmitting signals back to the telemetry unit  806  or another unit capable of receiving the signals. For example, the electrical stimulation system  800  may transmit signals indicating whether the electrical stimulation system  800  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  804  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.