Patent Publication Number: US-2012035684-A1

Title: Multiplexed, Multi-Electrode Neurostimulation Devices with Integrated Circuits Having Integrated Electrodes

Description:
RELATED APPLICATION AND CROSS REFERENCE 
     This application claims the benefit of U.S. Provisional Patent Application No. 61/151,171, filed on Feb. 9, 2009, titled “Multiplexed, Multi-Electrode Neurostimulation Devices with Integrated Circuits Having Integrated Electrodes”, which application is incorporated by reference in its entirety for all purposes in the Present Application. 
    
    
     FIELD OF THE INVENTION 
     The present invention is related to electrical devices and systems for electrical stimulation of living mammalian tissue and, more specifically, to implantable electrical leads that include satellite structures, wherein each satellite structure controllably delivers the electrical stimulation to tissue and each satellite structure includes a controller device coupled with one or more electrodes. 
     BACKGROUND 
     Implantable neurostimulators are used to deliver neurostimulation therapy to patients to treat a variety of symptoms or conditions such as chronic pain, tremor, Parkinson&#39;s disease, epilepsy, incontinence, or gastroparesis. Implantable neurostimulators may deliver neurostimulation therapy in the form of electrical pulses via implantable leads that include electrodes. To treat the above-identified symptoms or conditions, implantable leads may be implanted along nerves, within the epidural or intrathecal space of the spinal column, and around the brain, or other organs or tissue of a patient, depending on the particular condition that is sought to be treated with the device. 
     The length of the effective lifespan of implanted leads affects the benefit derived by a host patient. Replacing leads and leads components after implantation is generally to be avoided as increased costs and undesirable complications may arise when removing implanted leads or elements thereof is required. Implantable leads that demonstrate longer effective lifespan offer fewer health risks and are thereof of more benefit to the patient. 
     Various implantable lead designs may have different shapes, to include those leads that are commonly known as paddle leads and percutaneous leads. Paddle leads, which are typically larger than percutaneous leads, are directional and often utilized due to desired stimulus effect on the tissues or areas. Leads include several elements such as conductors, electrodes and insulators may be combined to produce a lead body. A lead may include one or more conductors extending the length of the lead body from a distal end to a proximal end of the lead. The conductors electrically connect one or more electrodes at the distal end to one or more connectors at the proximal end of the lead. The electrodes are designed to form an electrical connection or stimulus point with tissue or organs. Lead connectors (sometimes referred to as terminals, contacts, or contact electrodes) are adapted to electrically and mechanically connect leads to implantable pulse generators or RF receivers (stimulation sources), or other medical devices. An insulating material may form the lead body and surround the conductors for electrical isolation between the conductors and for protection from the external contact and compatibility with a host body. 
     Such leads may be implanted into a body at an insertion site and extend from the implant site to the stimulation site (area of placement of the electrodes). The implant site may be a subcutaneous pocket that receives and houses the pulse generator or receiver (providing a stimulation source). The implant site may be positioned a distance away from the stimulation site, such as near the buttocks or other place in the torso area. One common configuration is to have the implant site and insertion site located in the lower back area, with the leads extending through the epidural space in the spine to the stimulation site, such as middle back, upper back, neck or brain areas. 
     There is a long-felt need to provide improved methods and systems that deliver neuroelectrical stimulation to living tissue and increase the effective lifespan of implanted electrical stimulation leads and elements thereof. 
     SUMMARY 
     Implantable electrical stimulation devices are provided. Aspects of the devices include a multiplexed multi-electrode lead configured for neural stimulation. The multiplexed multi-electrode lead includes two or more individually addressable satellite electrode structures electrically coupled to a common conductor. Each satellite structure includes one or more integrated control circuits operatively to one or more electrodes of the comprising satellite structure. One or more electrodes may be formed via a direct conducting path from the integrated control circuit. 
     Also provided are systems that include the devices of the invention, as well as methods of using the systems and devices in a variety of different applications. Additional or alternative aspects of the invention include a multiplexed multi-electrode component configured for deep brain stimulation and/or sensing. 
     Alternate methods of manufacturing are further provided wherein the application of laser welding is avoided in the forming processes of the satellite electrode structures and an integrated control circuit, whereby the electrode structures and the integrated control circuit are shielded from undergoing mechanical stress imposed by laser welding. 
     INCORPORATION BY REFERENCE 
     All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. 
     Such incorporations include U.S. Nonprovisional patent application Ser. No. 12/305,894; PCT Patent Application Serial No. PCT/US2007/014509 titled “IMPLANTABLE MEDICAL DEVICES COMPRISING CATHODIC ARC PRODUCED STRUCTURES” and published as WO/2007/149546; U.S. Nonprovisional patent application Ser. No. 12/305,910 titled “Metal Binary and Ternary Compounds Produced by Cathodic Arc Deposition; PCT Patent Application Serial No. PCT/US2003/039524 published as WO 2004/052182; PCT Patent Application Serial No. PCT/US2005/031559 published as WO 2006/029090; PCT Patent Application Serial No. PCT/US2005/046811 published as WO 2006/069322; PCT Patent Application Serial No. PCT/US2005/046815 published as WO 2006/069323; PCT Patent Application Serial No. PCT US2006/048944 published as WO 2007/075974; and PCT Application Serial No. PCT/US2007/009270 published under publication no. WO/2007/120884. 
     The publications discussed or mentioned herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present invention is not entitled to antedate such publication by virtue of prior invention. Furthermore, the dates of publication provided herein may differ from the actual publication dates which may need to be independently confirmed. 
    
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
         FIG. 1  provides a view of percutaneous lead according to an aspect of the invention, where the percutaneous lead includes several individually addressable satellite electrode structures. 
         FIG. 1A  provides an exploded view of an electrode structure of the lead of  FIG. 1 . 
         FIG. 2  is a schematic of an electrode satellite structure that includes an integrated control circuit and at least one electrode, or “first electrode”. 
         FIG. 3  is an illustration of the first electrode and a second electrode separately coupled to first surface of the integrated control circuit. 
         FIG. 4  is an illustration of a third electrode that is coupled to the entire first surface of the integrated control circuit. 
         FIG. 5  is an illustration of a plurality of electrodes that are each coupled to the first surface of the integrated control circuit. 
         FIG. 6  is an illustration of a plurality of electrodes that are each coupled to various surfaces of the integrated control circuit. 
         FIG. 7  is an illustration of the integrated control circuit having an additional protective metal layer. 
         FIG. 8  is an illustration of the integrated control circuit of  FIG. 7  having an additional insulative layer. 
         FIG. 9  is an illustration of the integrated control circuit of  FIG. 7  encompassed by an additional hermetically sealing layer. 
         FIG. 10  is an illustration of the integrated circuit components of the satellite structures including the integrated control circuit positioned with a semiconductor holder and partially encased in an epoxy and a solid support comprising a lead frame. 
         FIG. 11  is a schematic diagram of an alternate integrated control circuit, or “module”, of  FIG. 2 . 
         FIG. 12  is a schematic diagram of a cuff electrode satellite. 
         FIG. 13A  is a perspective view of a band electrode coupled with the integrated control circuit of  FIG. 2  or the alternate integrated control module of  FIG. 11  and the lead of  FIG. 1 . 
         FIG. 13B  is a cut-away front view of the band electrode of  FIG. 13A  coupled with the integrated control circuit of  FIG. 2 . 
         FIG. 13C  is a schematic diagram of a paddle electrode satellite structure. 
         FIG. 14  is a schematic diagram of a suite of manufacturing equipment useful for fabricating the lead of  FIG. 1 , the satellite of  FIG. 2 , alternate integrated control module of  FIG. 11 , the cuff electrode satellite of  FIG. 12 , the band electrode of  FIG. 13A  and  FIG. 13B , and the paddle electrode of  FIG. 13C . 
         FIG. 15  is a process chart of a effective uses of the suite of manufacturing equipment for the fabrication of the lead of  FIG. 1 , the satellite of  FIG. 2 , alternate integrated control module of  FIG. 11 , the cuff electrode satellite of  FIG. 12 , the band electrode of  FIG. 13A  and  FIG. 13B , and the paddle electrode of  FIG. 13C . 
     
    
    
     DETAILED DESCRIPTION 
     Implantable neural stimulation devices are provided. Aspects of the devices include a multiplexed multi-electrode component configured for neural stimulation. The multiplexed multi-electrode component includes two or more individually addressable satellite electrode structures electrically coupled to a common conductor. The individually addressable satellite electrode structures include a hermetically sealed integrated control circuit operatively coupled to one or more electrodes. Also provided are systems that include the devices of the invention, as well as methods of using the systems and devices in a variety of different applications. 
     In further describing various aspects of the invention, devices of the invention are reviewed first in greater detail, followed by a description of systems and methods of using the same in various applications, including neural stimulation applications. 
       FIG. 1  shows a lead  200  including multiplexed multi-electrode components that are individually addressable satellite structures  202  positioned longitudinally on the lead  200 . The lead  200  includes two bus wires S 1  and S 2 , which are coupled to individually addressable electrode satellite structures, such as individually addressable satellite electrode structure  202 .  FIG. 1A  also shows individually addressable satellite electrode structure  202  with an enlarged view. Individually addressable satellite electrode structure  202  includes electrodes  212 ,  214 ,  216 , and  218 , located in the four quadrants of the cylindrical outer walls of satellite  202 .  FIG. 1B  provides a depiction of the arrangement of four electrodes. As indicated above, a given individually addressable satellite electrode structure may include more or less than four electrode elements. 
     For example, six electrode elements may be present, as shown in  FIG. 1C . Each individually addressable satellite electrode structure also contains integrated circuit component inside the structure which communicates with other satellite structures and/or distinct control units, e.g., to receive neurostimulation signals and/or configuration signals that determine which of the different electrodes are to be coupled to bus wires S 1  or S 2  of  FIG. 1A . 
       FIG. 2  is a schematic of an electrode satellite structure  202  that includes an integrated control circuit  300  and a first electrode  302 . The integrated control circuit  300  includes a control circuitry  304 , a selectable current pathway  306 , and a first surface  308 . The integrated control circuit  300  includes a device communications bus  310  that is coupled to a lead communications bus  312  of the lead  200 . The integrated control circuit  300  is operatively coupled with a current switch  314  of the selectable current pathway  306  (hereinafter, “selectable pathway”  306 ). The integrated control circuit  300  open and closes the current switch  314  in accordance with commands addressed to the comprising electrode satellite structure  202 , wherein the commands are received by the control circuit  300  via the device communications bus  310 . The integrated control circuit  300  preferably presents a thickness along the Y-axis within the range of ten microns and two hundred fifty microns, and more preferably presents a thickness along the Y-axis within the range of fifty microns and one hundred fifty microns. 
     The selectable current pathway  306  includes a power bus  316  that is coupled with a common conductor  318  of the lead  200 . The common conductor  316 , (hereinafter, “power bus”  316 ) is coupled to a plurality of satellite structures  202  and provides electrical power to each coupled satellite structure  202 . The device communications bus  310  is similarly separately coupled to each satellite structure  202  of the plurality of satellite structures  202 , wherein commands addressed to individual satellite structures  202  are provided to the plurality of satellite structures  202  via the device communications bus  310 . 
     The substantively hemispherical electrode  302  is coupled to the first surface  308  has a convex shape that extends away from the first surface  308 . The substantively hemispherical electrode  302  may preferably have an external diameter of between 0.5 millimeters to 2.0 millimeters, or more preferably an external diameter of between 1.0 millimeters to 1.5 millimeters 
     The first surface  308  preferably presents a thickness in a Y dimension of from 20 microns to 250 microns. The electrode  302  receives electrical power from the selectable pathway  306  when the current switch  314  is closed as controlled by the control circuit  300 . The electrode  302  transfers the electrical power received from the selectable pathway to a target site  320  of an enclosing mammalian tissue environment  322 . The roughness of each electrode  302  can range from smooth to a high degree of roughness. The advantage of affecting the performance of the electrode  302  by manufacturing techniques is thereby enabled. One or more electrodes  302  are coated with one or more of various films including, but not limited to, titanium nitride, iridium oxide, and platinum oxide. The film coating of one or more electrodes  302  is preferably within the range of ten angstroms and thirty thousand angstroms. The film coating of one or more electrodes  302  is more preferably within the range of one thousand angstroms and twenty thousand angstroms. 
     Alternatively, the first electrode  302  may be shaped as a substantively planar sheet having a uniform thickness of a top electrode surface as extending from the first surface  308  measured along the Y-axis. The thickness of the first electrode  302  as measured along the Y-axis and extending from the first surface  308  is preferably within one micron to 250 microns and more preferably from 50 microns to 150 microns. The thickness of the first electrode  302  along the top electrode surface as measured along the Y-axis and from the first surface  308  preferably varies less than 20% and more preferably varies less than 1%. 
       FIG. 3  is an illustration of the first electrode  302  coupled to a first area  324  and a second electrode  326  that is coupled to a second area  328  of the first surface  308  of the integrated control circuit  300 . Both the first electrode  302  and the second electrode  326  are coupled to the selectable pathway  306  receive electrical power from the selectable pathway  306  when the current switch  314  is closed as controlled by the control circuit  300 . Both the first electrode  302  and the second electrode  326  transfer the electrical power received from the selectable pathway to the target site  320  of the enclosing mammalian tissue environment  322 . 
       FIG. 4  is an illustration of a third electrode  330  that is coupled to the entire first surface  308  of the integrated control circuit  300 . The third electrode  330  may optionally or alternatively extend beyond the first surface  308  and preferably has a thickness in the Y-axis and extending away from the integrated controller  300  for from 20 microns to 300 microns. 
       FIG. 5  is a top view illustration of a plurality of first electrodes  302  that are each coupled to the first surface  308  of the integrated control circuit  300 . The first electrodes  302  preferably demonstrate a radius R that is within the range of from 5% to 25% of a width along an X-axis or a length along a Z-axis of the first surface  308 . Alternatively or additionally, the first electrodes  302  preferably demonstrate a radius R that is within the range of from 5% to 25% of a width along an X-axis or a length along a Z-axis the integrated control circuit  300 . 
       FIG. 6  is an illustration of a plurality of first electrodes  302  that are each coupled to various surfaces  308 ,  332 , and  334  of the integrated control circuit  300 . The first surface  308  is substantively orthogonal preferably with less 
       FIG. 7  is an illustration of the integrated control circuit  300  having an additional protective metal layer  336 . The metal layer  336  may alternatively, in various alternate configurations of the integrated control circuit  300 , extend to (a.) only partially cover the first surface  308 , the second surface  332  and/or the third surface  334 ; (b.) completely cover the first surface  308 , the second surface  332  and/or the third surface  334 ; and (c.) partially or completely encompass the integrated control circuit  300 . A first insulative material  338  insulates the control circuit  306  from the metal layer  336 , and an electrically conductive electrode pad  340  of the selectable pathway  306  extends through the first insulative material  338  to provide electrical power to one or more electrodes  302 ,  326  and  330 . A first aperture  342  permits the communications bus  310  to operatively couple with the lead communications bus  312  and a second aperture  344  enables the power bus  316  to operatively couple with the common conductor  318 . 
       FIG. 8  is an illustration of the integrated control circuit of  FIG. 7  having an additional second insulative material  346 . A fourth electrode  348  extends through the second insulative layer  346  and makes an operative electrical connection with the electrode pad  340  of the selectable pathway  306 . This fourth electrode may be formed by the steps of: (1.) applying a photo resist material layer by photolithography wherein the photo resist material is deposited on the first area  324  of the first face  308 ; (2.) flowing the material of the second insulative layer  346  in a liquid state over the first face  308  and allowing the liquid material to return to a solid state and thereby form the second insulative layer  346 ; (3.) removal of the photo resist by wet or dry etch, or other suitable material removal process known in the art; and (4.) depositing a conductive material onto the first area to form the fourth electrode  348 . It is understood that other suitable methods known in the art may be used to form and operatively couple the fourth electrode and to the electrode pad  340  and/or the first area. 
     Individually addressable satellite electrode structures  202  of the leads  200  have hermetically sealed integrated circuit components, such that they include the sealing layer  346  which seals the integrated control circuit  300  from the implanted environment  322  so that the satellite structure  202  maintains functionality, at least for the intended lifespan of the lead  200 . 
     The nature of the sealing layer  346  may vary, so long as it maintains the functionality of the satellite structure  202  in the implanted environment for the desired period of time, such as one week or longer, one month or longer, one year or longer, five years or longer, ten years or longer, twenty-five years or longer, forty years or longer. 
     In some instances, the sealing layer  346  is a conformal, void-free sealing layer  346 , where the sealing layer  346  is present on at least a portion of the outer surface  347  of the integrated control circuit  300  (described above). In some instances, this conformal, void-free sealing layer  346  may be present on substantially all of the outer surfaces of the integrated circuit component. Alternatively, this conformal, void-free sealing layer  346  may be present on only some of the surfaces of the integrated circuit, such as on only one surface or even just a portion of one surface of the integrated circuit component. As such, some sensors have an integrated circuit component completely encased in a conformal, void free sealing layer. Other sensors are configured such that only the top surface of an integrated circuit component is covered with the conformal, void-free sealing layer  346  may be a “thin-film” coating, in that its thickness of the sealing layer along the three orthogonal axes of the Y-axis, X-axis and Z-axis is such that it does not substantially increase the total volume of the integrated circuit structure with which it is associated, where any increase in volume of the structure that can be attributed to the layer may be 10% or less, such as 5% or less, including 1% or less by volume. In some instances, the seal layer  346  has a thickness in a range from 0.1 micron to 10.0 micron, such as in a range from 0.3 micron to 3.0 micron thick, and including in a range 1.0 um thick. 
     The seal layer  346  may be produced on the integrated circuit component using any of a number of different protocols, including but not limited to planar processing protocols, such as plasma-enhanced-chemical-vapor deposition, physical-vapor deposition, sputtering, evaporation, cathodic-arc deposition, low pressure chemical-vapor deposition. 
     Additional description of conformal, void-free sealing layers that may be employed for sensors of the invention is provided in PCT application serial no. PCT/US2007/009270 published under publication no. WO/2007/120884, the disclosure of which is herein incorporated by reference. 
     Also of interest as sealing elements are corrosion-resistant holders  349  having at least one conductive feed-through and a sealing layer; where the sealing layer  346  and the corrosion-resistant holder  349  are configured to define a hermetically sealed container that encloses the integrated control circuit  300 . The conductive feed-through may be a metal, such as platinum, iridium, niobium, titanium etc., an alloy of metal and a semiconductor, a nitride, a semiconductor or some other convenient material. In some instances, the corrosion-resistant holder comprises silicon or a ceramic. While dimensions may vary, the corrosion-resistant holder may have walls that are at least one micron thick, such as at least fifty microns thick, where the walls may range from one micron to one hundred twenty-five microns, including from twenty five microns to one hundred microns. Alternatively, the sealing layer  346  may be metallic, where metals of interest include noble metals and alloys thereof, such as niobium, titanium, platinum and platinum alloys. Dimensions of the sealing layer may also vary, ranging in some instances from 0.5 um thick or thicker, such as 2.0 um thick or thicker, and including 20 um thick or thickness, where sealing layer thicknesses may range from 0.5 to 100 um, such as from 1 to 50 um. 
     In certain configurations, the structure  202  further includes the seal layer  346  present in the hermetically sealed volume. In some cases, the hermetically sealed volume ranges from 1 pl. to 1 milliliter. 
     In some instances, an in-vivo corrosion-resistant holder  349  is a structure configured to hold the integrated control circuit  300  such that the integrated control circuit  300  is bounded on all but one side by the walls of the corrosion-resistant holder  349 . For example, the corrosion-resistant holder  349  may include sidewalls and a bottom, where the holder may have a variety of different configurations as long as it contains the integrated circuit component in a manner such that the component is held in a volume bounded on all but one side. 
     Accordingly, the shape  349  of the holder may be square, circular, ovoid, rectangular, or some other shape as desired. Additional description of corrosion resistant holders that may be employed for sensors  300 .C of the invention is provided in PCT application serial no. 
     PCT/US2005/046815 published under publication no. WO/2006/069323, the disclosure of which is herein incorporated by reference. 
     Of particular interest are aspects in which at least one electrode  302  is formed as via a direct conducting path from the integrated control circuit  300 . As such, the material(s) forming the electrode  302  may be recessed, convex, or flush with respect to an outer surface of the lead  200 . In this manner, economical use of manufacturing materials and processes may be achieved. Further, in various aspects, the overall diameter of the lead  200  may be relatively small, e.g., approximately 0.5 mm to 3.0 mm. In some aspects, the lead diameter may be approximately 1.0 mm to 1.5 mm, or approximately 1.25 mm. 
     Various aspects may permit use of a guidewire lumen (not shown) of a relatively small dimension. In various aspects, a material may be deposited or otherwise associated with the integrated control circuit  300  to strengthen or otherwise support the integrated control circuit  300  and associated components. The preferable materials to form the support structure  358  include, for example, platinum, platinum iridium, niobium, and titanium. A skilled artisan will appreciate that various other materials and combinations of materials may be employed. 
     Referring now to  FIG. 9 , the lead  200  may include one or more lead components, to include a plurality of satellite structures  202 . Lead components are elongated structures having lengths that are  2  times or longer than their widths, such as 5 times or longer than their widths, including 10, 15, 20, 25, 50, 100 times or longer than their widths. In certain instances, the leads have lengths of 10 mm or longer, such as 25 mm or longer, including 50 mm or longer, such as 100 mm or longer. A variety of different lead configurations may be employed, where the lead in various aspects is an elongated cylindrical structure having a proximal end  350  and a distal end  352 . The proximal end  350  may include a connector element  354 , e.g., an IS-1 connector, for connecting to an implantable lead control unit  355 , e.g., present in a “can” or analogous device. The lead  200  may include one or more lumens, e.g., for use with a guidewire (not shown), for housing one or more conductive elements, e.g., wires  312  and  318 , etc. The distal end of the lead  200  may include a variety of different features as desired, e.g., a securing means. Leads  200  may be fabricated as flexible structures, where the internal common conductor  318  and the lead communications bus  312  may include wires, coils or cables made of a suitable material, such as alloy MP35N (a nickel-cobalt-chromium-molybdenum alloy), platinum, platinum-10 iridium, etc. A lead body  200 .A may be any suitable material, such as a polymeric material, including polyurethane or silicone. 
     Lead components of the invention may have a variety of shapes, as desired. In some instances, the leads  200  have a standard percutaneous shape, as found in conventional percutaneous neural stimulation leads. In some instances, the leads have a standard paddle shape, as found in conventional paddle neural stimulation leads. 
     Devices of invention include a multiplexed multi-electrode component. Multiplexed multi-electrode components include two or more electrodes  302  which are electrically coupled, either directly or through the selectable pathway  306 , to the common conductor  318  or set of common conductors  318 , such that the two or more electrodes  302  share one or more conductors  318 . The term “conductor” refers to a variety of configurations of electrically conductive elements, including wires, cables, etc. A variety of different structures may be implemented to provide the multiplex configuration. Multiplex configurations of interest include, but are not limited to, those described in: PCT application no. PCT/US2003/039524 published as WO 10 2004/052182; PCT application no. PCTI US2005/031559 published as WO 2006/029090; PCT application no. PCTI US2005/046811 published as WO 2006/069322; PCT application no. PCTI US2005/046815 published as WO 2006/069323; and PCT application no. PCT US2006/048944 published as WO 2007/075974; the disclosures of which are herein incorporated by reference. The multiplexed multi-electrode components include two or more individually addressable satellite electrode structures  202 . In some instances, more than two individually addressable satellite structures  202  are present in the device, such as three or more, four or more, five or more, six or more, ten or more, twenty or more (including twenty-four), thirty or more, fifty or more, etc. Individually addressable satellite electrode structures  202  are those that can be individually controlled from a site remote from the satellite electrode structure  202 , such as a separate implanted control unit to which the device is operatively coupled or to an extracorporeal control unit. Satellite electrode structures  202  are structures that include an integrated circuit control device  300  and at least one electrode element  302 . The satellite electrode structures  202  of the invention include control circuitry  304  in the form of an integrated circuit that imparts addressability to the satellite electrode structure. 
     Referring now to  FIG. 10 , integrated circuit components of the satellite  202  structures are constructs that include the integrated control circuit  300  positioned with the corrosion-resistant holder  349  and partially encased in an epoxy  356  and a solid support  358  comprising a lead frame  360 . In variations of the invention, the solid support  358  may be small, for example where it is dimensioned to have a width ranging from 0.01 mm to 100 mm, such as from 0.1 mm to 20 mm, and including from 0.5 mm to 2 mm; a length ranging from 0.01 mm to 100 mm, such as from 0.1 mm to 20 mm, and including from 0.5 mm to&#39; 2 mm, and a height ranging from 0.01 mm to 10 mm, including from 0.05 mm to 2 mm, and including from 0.1 mm to 0.5 mm. 
     The satellite structure  202  may take a variety of different configurations, such as but not limited to: a chip configuration, a cylinder configuration, a spherical configuration, a disc configuration, or other suitable configuration known in the art. A particular configuration may be selected based on intended application and/or method of manufacture. While the material from which the solid support  358  is fabricated may vary considerably depending on the particular lead  200  for which the satellite structure  202  is configured for use. The preferable materials to form the solid support  358  as an electrically conductive element include, for example, platinum, platinum iridium, niobium, and titanium. In certain instances when it is desirable that the solid support  358  be partially or wholly electrically insulating, the solid support  358  may be made up in whole or in part of an insulative material, such as silicone, polyurethane, urethane co-polymers, or various other materials and combinations of materials. 
     Referring now to  FIG. 11 , the integrated circuit components of the individually addressable satellite electrode structures  202  may include a number of distinct functional blocks, i.e., modules. An alternate controller module  362  of the satellite structure  202  is provided that includes the integrated control circuit  300 . The integrated control circuit  300  is positioned on a substrate  364 , and the substrate  364  is coupled with a circuit board  366  of the alternate controller module  362 . The substrate  364  may comprise a semiconductor material, such as a silicon wafer. The integrated control circuit  300  may, and/or the alternate controller module  362  alternatively or additionally may, include a number of distinct functional circuitry blocks  300 .A- 300 .H, or “blocks”  300 .A- 300 .H. In some instances, the alternate controller module  362 , or alternatively or additionally the integrated control circuit  300 , includes at least the following functional blocks: a power extraction functional block  300 .A; an energy storage functional block  300 .B; a sensor functional block  300 .C; a communication functional block  300 .D; and a device configuration functional block  300 .E. The alternate controller module  362  may further include additional blocks  300 .F- 300 .H. 
     The power extraction block  300 .A is coupled with the common conductor  318  and directs received electrical energy to the electrode  302  via the electrode pad  340  and alternatively for storage in the energy storage block  300 .B. It is understood that the alternate controller module  362  and/or the integrated control circuit may comprise a plurality of electrode pads  340 . The sensor block  300 .C, or “sensor”  300 .C, provides a biological parameter detection or measurement capability to the integrated control circuit  300 , wherein detections or measurements generated by the sensor block  300 .C are transmitted to an implantable control unit and/or the extracorporeal control unit via the communication block  300 .D. The communication block  300 .D is communicatively coupled with the lead communications bus  312  and is communicatively there through to the implantable control unit and/or the extracorporeal control unit. The communication block  300 .D further provides programming instructions and data received via the power and signal bus  109  to the device configuration block  300 .E. 
     Within a given satellite electrode structure  202 , at least some of, e.g., two or more, up to and including all of, the functional blocks  300 .A- 300 .H may be present in the single integrated control circuit  300 . By single integrated circuit is meant a single circuit structure that includes all of the different desired functional blocks for the invented satellite  202 . In these types of structures, the integrated control circuit  300  is a monolithic integrated circuit that is a miniaturized electronic circuit which may be made up of semiconductor and passive components that have been manufactured in the surface of a thin substrate  364  of semiconductor material. Sensor blocks  300 .C of the invention may also include integrated circuits that are hybrid integrated circuits, which are miniaturized electronic circuits constructed of individual semiconductor devices, as well as passive components, bonded to the substrate  364  or the circuit board  364 . 
     Within a given satellite electrode structure  202 , at least some of, e.g., two or more, up to and including all of, the functional blocks  300 .A- 300 .H may be present in the integrated control circuit  300  as a single integrated circuit. By single integrated circuit is meant a single circuit structure that includes all of the different desired functional blocks for the device. In these types of structures, the integrated control circuit  300  is a monolithic integrated circuit that is a miniaturized electronic circuit which may be made up of semiconductor and passive components that have been manufactured in the surface of the thin substrate  354  of semiconductor material. 
     Sensors  300 .C of the invention may also include integrated circuits that are hybrid integrated circuits, which are miniaturized electronic circuits constructed of individual semiconductor devices, as well as passive components, bonded to the substrate  364  or the circuit board  366 . 
     A given satellite electrode structure  202  may include a single electrode element  302  operatively associated with an integrated control circuit  300 , or two or more electrodes  302  operatively associated with the same integrated control circuit  300 , such as three or more electrodes  302 , four or more electrodes  320 , six or more electrodes  302 , or a plurality of electrodes  302 . In various aspects, the satellite structure  202  includes two or more electrode elements  202 , such as three or more electrode elements  202 , including four or more electrode elements  302 , or a plurality of electrodes  302 , wherein the satellite structure  202  is a segmented electrode structure. The various electrode elements  302  may be positioned in three-dimensional space relative to their integrated control circuit  300  to which the electrode elements  302  are electronically associated in a number of different ways. For example, the multiple electrodes  302  may be radially distributed, i.e., axially uniformly positioned, about the integrated control circuit  300 . Alternatively, the multiple electrodes  302  may be positioned to a first surface  308  of integrated control circuit  300 . 
     Referring now to  FIG. 12 , a cuff electrode  368  that may be comprised within the lead  200 . The cuff electrode device  368  includes integrated control circuits  300 , partially curved support structures  370 , and one or more electrodes  302 . In various aspects, the at least one curved support structure  370  may be mechanically associated with the integrated control circuits  300 , or be independent, integrated, or partially integrated support structures  370 . The curved support structure  370  may be formed from various materials, e.g., platinum, platinum-iridium, etc. The one or more electrodes  302  may be disposed on at least one inside surface of the curved support structure  370 , such that the electrodes  302  contact targeted tissue, e.g., the vagus nerve  372 . The support structure  370  and/or overall construction of the cuff electrode device  368  may facilitate avoidance of stimulation of untargeted tissue, e.g., the voice box. Such form factors include curved support structures  370  forming an aperture therein, e.g., “cuff-shaped”, “clamshell-shaped”, etc. Various components and combinations of components may be similar to above-described multiplexed, multi-electrode device, facilitating stimulation and/or sensing of targeted tissue areas. 
     Referring now to  FIG. 13A ,  FIG. 13B  and  FIG. 13C , in a still additional example, the electrode  302  is formed by physically attaching a predetermined structure with respect to the integrated control circuit  300  and may be attached, for example, to the first surface  302 , of the integrated control circuit  300  such that a direct conducting path is formed from the electrode contact pad  340  of the integrated control circuit  300 . In this manner, the method of the present invention provides for many stimulation locations with significantly less complexity than hard-wired approaches. 
       FIG. 13A  is an isometric view of the surface band-type electrode  374  attached to the lead  200  and contacting the integrated control circuit  300 , and  FIG. 13B  is a cut-away side view of the surface band-type electrode  374  attached to the lead  200  and contacting the first surface  308  of the integrated control circuit  300 , or alternatively the alternate integrated control controller module of  FIG. 11 . The surface band-type electrode  374  may reside in parallel with a lead outside surface  200 .B of the lead body  200 .A. 
       FIG. 13C  shows a paddle lead  375  that includes multiple individually addressable satellite electrode structures  202 . Underlying the shown electrode structures  202  may be a laser cut pattern of conductive elements as described above. As shown, all of the electrode structures  202  of the paddle  375  are coupled to two wires S 1  and S 2  such that the paddle lead  375  has a multiplexed configuration. 
     [Referring now to  FIG. 14 ,  FIG. 14  illustrates an equipment suite  376  of electronic device and semiconductor fabrication equipment useful in partially or wholly manufacturing the lead  200 , the invented device  202 , to include the cuff device  368 , as well as components thereof, such as the electrodes  302 , the lead communications bus  312 , the lead common conductor  318 , and the satellites  202 . One or more photolithography systems  378  enable the positioning of photoreseist material onto the substrate  364 . One or more dry etch systems  380  and wet etch systems  382  are used to remove exposed material from the substrate  364 . A laser ablation system  38  and/or a mechanical ablation system  386 , e.g., a milling system are used to ablate material from the substrate  364 . One or more deposition systems  388 .A- 388 .N, e.g., sputtering systems, liquefied material deposition systems, are used to deposit materials, such as the insulative material  338  and  346 , the corrosion-resistant holder  349 , the metal protection layer  336 , onto the substrate  364 , into the satellite  202 , or to form the satellite  202 . One or more sealing systems  390  applies and secures the sealing layer  346  as part of the satellite  202 . An electro-forming system  392  causes the electrode  102  to establish an electrical connection with the electrode contact pad  340 . A substrate cleaning system  394  removes debris and excess, unwanted contamination from the satellite  202 . A fabrication controller  396  is an information technology system that may be communicatively coupled to one or more equipments  378 - 394  to manage the whole or partial fabrication of the lead  200 , one or more satellites  202 , to include the cuff device  176 , as well as components thereof, such as the electrodes  1302 , the lead communications bus  312 , and the lead common conductor  318 . 
     One or more deposition systems  388 .A- 388 .N are used to implement deposition techniques in certain aspects of fabrication of one or more leads  200 , satellites  202 , and electrodes  302  devices or components thereof include, but are not limited to: electroplating, cathodic arc deposition, plasma spray, sputtering, e-beam evaporation, physical vapor deposition, chemical vapor deposition, and plasma enhanced chemical vapor deposition. Material removal techniques of interest include, but are not limited to: reactive ion etching, anisotropic chemical etching, isotropic chemical etching, planarization, e.g., via chemical mechanical polishing, laser ablation, electronic discharge machining (EDM), etc. Also of interest are lithographic protocols. Of interest in certain aspects is the use of planar processing protocols, in which structures are built up and/or removed from a surface or surfaces of an initially planar substrate using a variety of different material removal and deposition protocols applied to the substrate in a sequential manner. 
     In particular, The roughness of each electrode  302  can range from smooth to a high degree of roughness by variable applications of the equipment suite  376 . The advantage of affecting and improving the performance of the electrode  302  by manufacturing techniques is thereby enabled. 
     Referring now to  FIG. 15 ,  FIG. 15  is a process chart in accordance with the method of the present invention for to apply the equipment suite  376  to wholly or partially manufacture the lead  200 , one or more satellites  202 , to include the cuff device  368  and the paddle lead  375 , as well as components thereof, such as the electrodes  302 , the lead communications bus  312 , and the lead common conductor  318 . In optional step  1502  the integrated control circuit  300  is fabricated by standard electronic and semiconductor device manufacturing methods known in the art, wherein the integrated control circuit  300  may optionally be attached to the substrate  364 . In step  1504  photoresist is added to the substrate  364  and/or the circuit board  366 . In step  1506  material is removed or alternatively added to the integrated control circuit  300  and/or the circuit board  366 , wherein the material may be or at least partially form, for example, the support structure  370 , one or more functional blocks  300 .A- 1300 .F, the satellite  202 , the electrode  302 , the lead  200 , the electrode contact pad  340 , the sealing layer  346 , the first insulative material  338 , the integrated circuit holder  349 , and the metal protection layer  336 . In optional step  1508  the photoresist is removed. In optional step  1510  the electro-forming system  392  is applied to effectuate electro-forming within the lead  200  and/or one or more satellites  202 . In step  1512  a human operator or the fabrication controller  396  determines whether to (a.) continue the manufacturing process by repeating a variation of the cycle of steps  1504  through  1512 , or to (b.) proceed on to step  1514  and to apply the sealing system  1390  to hermetically seal part or all of the lead  200 , the cuff electrode  368 , the paddle lead  375  and/or one or more satellites  202 , well as components thereof, such as the lead common conductor  318  and the lead communications bus  312 . 
     Methods of manufacturing the lead  200 , the satellites  200 ,  368  and the electrodes  302  and  374  are further provided wherein the application of laser welding is avoided in forming and assembling the lead  200 , the satellite electrode structures  202  and electrodes  302  and  374 . The lead  200 , the satellite electrode structures  202  and electrodes  302  and  374  are thereby shielded from undergoing mechanical stress imposed by a laser welding process. 
     In a first example, the electrode  302  is formed by exposure of the thick metal protection layer  336  of the integrated control circuit  300  such that a direct conducting path is formed from the electrode contact of the integrated control circuit  300 . In this manner, the electrode  302  provides for many stimulation locations with significantly less complexity than hardwired approaches. 
     In a second example, the fourth electrode  348  is formed by blocking the flow of the second insulative material  346  to the conductive material of the electrode connection of the integrated control circuit  300 . In this manner, the fourth electrode  348  provides for many stimulation locations with significantly less complexity than hard-wired approaches. 
     In a third example, the electrode is formed by creating electrodes, e.g., “posts”, at various predetermined positions with respect to the integrated control circuit  300 . 
     Such positions include over the metal layer  336  lay of the integrated circuit such that a direct conducting path is formed from the electrode contact of the integrated control circuit  300 . In this manner, the first electrode  302  provides for many stimulation locations with significantly less complexity than hard-wired approaches. 
     In a fourth example, the first electrode  302  is formed by physically attaching a predetermined structure with respect to the integrated control circuit  300 . Such structures include a surface band-type electrode and may be attached, for example, to the first surface  308  of the integrated control circuit  300  such that a direct conducting path is formed from the electrode contact pad  340  of the integrated control circuit  300 . In this manner, the first electrode  302  provides for many stimulation locations with significantly less complexity than hardwired approaches. 
     In a fifth example, the first electrode  302  is formed via a milling technique such as mechanical or laser ablation, that a direct conducting path is formed from removing the second insulative material  346  above the first are  324  of the first surface  308  on the integrated circuit. In this manner, the first electrode  302  provides for many stimulation locations with significantly less complexity than hard-wired approaches. 
     In a sixth example, the electrode  302  is formed via electroforming or similar suitable techniques known in the art such that a direct conducting path is formed from the electrode contact pad  340  of the integrated control circuit  300 . In this manner, the first electrode  302  provides for many stimulation locations with significantly less complexity than hard-wired approaches. 
     In a seventh example, the electrode  302  is formed by suitable deposition techniques and systems including, but not limited to cathodic arc deposition, electroplating, plasma spray, sputtering, e-beam evaporation, physical vapor deposition, chemical vapor deposition, and plasma enhanced chemical vapor deposition. 
     Any of a variety of different protocols may be employed in manufacturing the elements and devices of the invention. For example, molding, deposition and material removal, planar processing techniques, such as Micro-Electro-Mechanical Systems (MEMS) fabrication, may be employed. Deposition techniques that may be employed in certain aspects of fabrication of the devices or components thereof include, but are not limited to: electroplating, cathodic arc deposition, plasma spray, sputtering, e-beam evaporation, physical vapor deposition, chemical vapor deposition, plasma enhanced chemical vapor deposition, etc. Material removal techniques of interest include, but are not limited to: reactive ion etching, anisotropic chemical etching, isotropic chemical etching, planarization, e.g., via chemical mechanical polishing, laser ablation, electronic discharge machining (EDM), etc. Also of interest are lithographic protocols. Of interest in certain aspects is the use of planar processing protocols, in which structures are built up and/or removed from a surface or surfaces of an initially planar substrate using a variety of different material removal and deposition protocols applied to the substrate in a sequential manner. 
     In some instances, laser cut wires are employed as conductive elements for devices of the invention, such as for conductive elements of lead elements of devices of the invention. For example, conductive elements may be laser cut from a single sheet of metal. The pattern of the laser cut conductive elements may be chosen to match the positioning of the individually addressable satellite electrode structures of the lead. In this manner, the conductors and electrode structures may be aligned and then overlaid with the appropriate polymeric material to produce the desired lead structure. The laser cut conductive elements may have a variety of configurations from linear to curvilinear, sinusoidal or other fatigue resistance configuration. Instead of laser cutting, the conductor could also be fabricated using a deposition protocol, such as described above. 
     Devices of the invention may be implanted using any convenient protocol. Standard implantation procedures for percutaneous and paddle leads may be adapted for implantation of devices of the invention. The devices may be configured for ease of implantation. For example, devices may include a deployable element, such as lead components that inflate, e.g., with a gas or suitable liquid medium, to assume a desired configuration. 
     Also provided are systems that include one more neural stimulation devices as described above operatively coupled to an implantable controller, which may be an implantable pulse generator. The implantable controller may be any suitable controller, including any of a number of implantable pulse generators currently employed for neurostimulation procedures, where the devices may be modified as desired to work with multiplexed multi-electrode neurostimulation devices of the invention. Also part of the systems may be any number of additional components, as desired, including extra-corporeal control units configured to transmit data and/or power to and/or receive data from the implantable components. 
     Also provided are methods of using the systems of the invention. The methods of the invention generally include: providing a system of the invention, e.g., as described above, that includes an implantable controller and neurostimulation device. The system may be implanted in a suitable subject using any convenient approach. Following implantation, the system may be employed to as desired to treat a condition of interest. 
     It is to be understood that this invention is not limited to particular aspects described, as such may vary. It is also to be understood that the terminology used herein is for the purpose of describing particular aspects only, and is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims. 
     Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limit of that range and any other stated or intervening value in that stated range, is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included in the smaller ranges and are also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention. 
     Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present invention, representative illustrative methods and materials are now described. 
     All publications and patents cited in this specification are herein incorporated by reference as if each individual publication or patent were specifically and individually indicated to be incorporated by reference and are incorporated herein by reference to disclose and describe the methods and/or materials in connection with which the publications are cited. The citation of any publication is for its disclosure prior to the filing date and should not be construed as an admission that the present invention is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided may be different from the actual publication dates which may need to be independently confirmed. 
     It is noted that, as used herein and in the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise. It is further noted that the claims may be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as “solely,” “only” and the like in connection with the recitation of claim elements, or use of a “negative” limitation. 
     As will be apparent to those of skill in the art upon reading this disclosure, each of the individual aspects described and illustrated herein has discrete components and features which may be readily separated from or combined with the features of any of the other several aspects without departing from the scope or spirit of the present invention. Any recited method can be carried out in the order of events recited or in any other order which is logically possible.