Patent Publication Number: US-8116880-B2

Title: Paddle-style medical lead and method

Description:
RELATED APPLICATIONS 
     This application is a divisional of U.S. Ser. No. 10/692,244, filed Oct. 23, 2003, now allowed, which claims priority to provisional U.S. Application Ser. No. 60/420,570, filed Oct. 23, 2002, and provisional U.S. Application Ser. No. 60/508,107, filed Oct. 2, 2003, all of which are incorporated herein by reference. 
    
    
     FIELD 
     This application relates generally to medical leads for electrical stimulation or sensing and methods of use thereof, and more particularly to a paddle-style lead, for example, for spinal cord stimulation and methods of use thereof. 
     BACKGROUND 
     Currently anesthesiologists may non-surgically implant a percutaneous versions of medical leads for spinal cord stimulation (SCS) with Touhy needles. Typically, percutaneous versions of medical leads have been various standard cylindrical styles rather than flattened paddle style leads, which tend to be surgically implanted by surgeons with the associated discomfort, expense and inconvenience of surgical procedures. Paddle-style leads, however, are at least perceived to be more stable in their location after implantation. 
     U.S. Pat. No. 6,309,401 and EP Publication No. 1 048 270 discloses an apparatus for percutaneous implant of a paddle style lead in which a needle having a flattened cross section is used. U.S. Pat. No. 6,309,401 and EP 1 048 270 are incorporated herein by reference in their entirety, and particular note is made of the flattened needle, which may be used with certain exemplary embodiments of the medical lead disclosed herein. 
     There is a well-known need or desire for a paddle-style lead that can be implanted without performing a surgical procedure, such as a laminectomy or laminotomy. 
     SUMMARY 
     A medical lead is provided for electrical stimulation or sensing. Exemplary embodiments of the medical lead are adapted to facilitate repositioning, withdrawal or explanting the medical lead, as well as using the features of a flat lead paddle to anchor the lead to the connective tissue. Exemplary embodiments of the medical lead are adapted for percutaneous introduction of the medical lead through an introducer needle, such as a flattened Tuohy needle. 
     An exemplary medical lead has a generally flat paddle on the distal end of the lead body. An electrode array is provided on the paddle, with the electrode array displaced along the length of the paddle toward the distal end. The length of the paddle between the electrode array and proximal end of the paddle allow the electrode array may be advanced into position for electrical stimulation or sensing with a proximal portion of the flat paddle extending through connective tissue, such as the ligamentum flavum. Because the edge formed by the proximal end of the paddle is not pushed through the connective tissue, it does not interfere with repositioning, withdrawing or explanting the medical lead. In addition, the flat features of the paddle may be used to anchor the lead to the connective tissue. 
     A first exemplary embodiment of the medical lead comprises a generally round or tubular lead body having proximal and distal ends, and at least one electrical conductor extending between the proximal and distal ends. A connector is provided on the proximal end of the lead body in electrical communication with the electrical conductor. A generally flat paddle on the distal end of the lead body has an electrode array comprising at least one electrode in electrical communication with the electrical conductor. The paddle has proximal and distal ends and a length extending between the proximal and distal ends. The electrode array is displaced along the length of the paddle toward the distal end, whereby the electrode array may be advanced into position for electrical stimulation or sensing with the flat paddle extending through connective tissue, such as the ligamentum flavum. 
     A second exemplary embodiment of the medical lead generally comprises a generally round or tubular lead body having proximal and distal ends, and at least one electrical conductor extending between the proximal and distal ends. A connector is provided on the proximal end of the lead body in electrical communication with the electrical conductor. A generally flat paddle on the distal end of the lead body has an electrode array comprising at least one electrode in electrical communication with the electrical conductor. The paddle has proximal and distal ends and a length extending between the proximal and distal ends. The electrode array is displaced along the length of the paddle toward the distal end such that the portion of the flat paddle proximal of the electrode array has a length of at least 1½ inches (40 mm). 
     In an exemplary aspect of the first and second exemplary embodiments, a medical lead system is provided comprising the medical lead and an anchor adapted for clamping the flat paddle and anchoring it to connective tissue, such as the ligamentum flavum. For example, the anchor may comprise two clamping jaws adapted to clamp the major surfaces of the flat paddle therebetween. One of the clamping arms may optionally be provided with at least one rib, e.g., a plurality such as three ribs, adapted to engage the flat paddle and retain it in position. The clamping arms may be designed to be separable, with the clamping arms being provided with mating knobs and cavities or other features for attaching the clamping arms together. 
     A third exemplary embodiment is a medical lead system that generally comprises a medical lead and an anchor. The medical lead comprises a generally round or tubular lead body having proximal and distal ends, and at least one electrical conductor extending between the proximal and distal ends. A connector is provided on the proximal end of the lead body in electrical communication with the electrical conductor. A generally flat paddle on the distal end of the lead body has an electrode array comprising at least one electrode in electrical communication with the electrical conductor. The paddle has proximal and distal ends and a length extending between the proximal and distal ends, with the electrode array optionally being displaced along the length of the paddle toward the distal end. The anchor is configured for attachment to the paddle to anchor the paddle relative to biological tissue. 
     In a fourth exemplary embodiment, a method generally comprises percutaneously introducing distal end of the paddle with an introducer needle generally through connective tissue, such as the ligamentum flavum, into or adjacent a desired stimulation or sensing site, such as epidural space for spinal cord stimulation, in a patient with the proximal end of the paddle left extending out from the connective tissue. The flat paddle may be anchored to the connective tissue. The paddle may be repositioned or removed without cutting through or dissecting the connective tissue (e.g., ligamentum flavum). 
     In an exemplary embodiment of an implantation method, a medical lead is used having a generally flat paddle having proximal and distal ends and a length extending between the proximal and distal ends, and an electrode array comprising at least one electrode, with the electrode array being displaced along the length of the paddle toward the distal end. The method of this exemplary embodiment generally comprises (a) percutaneously introducing distal end of the paddle generally anteriorly through the ligamentum flavum into an epidural space of a patient through a needle with the proximal end of the paddle remaining on the posterior side of the ligamentum flavum; and anchoring the paddle to the posterior side of the ligamentum flavum. 
     An additional exemplary embodiment includes a medical lead having an identification marker for determining orientation or identifying the lead. For example, the marker may provide a definite indication of the direction of the lead (which way it is facing), and/or be coded to identify the model or serial number of a lead. 
     In yet another exemplary embodiment of a medical lead, the lead generally comprises a generally flat paddle on the distal end of the lead body. The paddle has first and second major surfaces, and an electrode array comprising at least one electrode in electrical communication with the electrical conductor, the electrode array having directional electrical field properties relative to the first and major surfaces of the paddle. An orientation marker is provided for determining orientation of the lead, the orientation marking including fluoroscopically viewable material. 
     In still another exemplary embodiment of a medical lead, the lead generally comprises a lead body having proximal and distal ends, and at least one electrical conductor extending between the proximal and distal ends. A connector is on the proximal end of the lead body in electrical communication with the electrical conductor. A generally flat paddle is provided on the distal end of the lead body. The paddle has proximal and distal ends, first and second major surfaces, and a length extending between the proximal and distal ends. An electrode array is provided on the paddle comprising at least one electrode in electrical communication with the electrical conductor, the electrode array having directional electrical field properties relative to the first and second major surfaces. An orientation marker is provided for determining orientation of the lead. The orientation marking includes fluoroscopically viewable material. 
     Yet another exemplary embodiment is a combination or set comprising a paddle-style medical lead and a flattened needle. Preferably the combination further includes a plastic or elastomeric stylet that is cable of being withdrawn from the needle even if the needle has been subjected to plastic deformation. 
     Still another exemplary embodiment is a system comprising a medical lead and an implantable pulse generator. The system preferably includes at least one or two external programmer(s), such a physician programmer and a patient programmer. 
     These and other features are described hereinafter or in the drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a schematic view of an exemplary embodiment of a system including a medical lead, implantable pulse generator (IPG) and programmer. 
         FIG. 2  illustrates various anatomical features of a portion of the vertebral column, including connective tissue, such as the ligamentum flavum through which medical leads are passed into the epidural space for electrical stimulation or sensing of the nerves of the spinal cord. 
         FIG. 3  is a cross sectional view along a transverse plane of a vertrebral column. 
         FIG. 4  is a plan view of an exemplary paddle-style medical lead of the disclosure. 
         FIG. 5  is a plan view the paddle of  FIG. 4 . 
         FIG. 6  is a partial view of a second exemplary embodiment of the paddle-style lead, illustrating among other things an orientation marker. 
         FIG. 7  is an enlarged view of a portion of the exemplary medical lead of  FIG. 6 , illustrating features of an exemplary electrode and paddle. 
         FIG. 8  is an exploded, partial view of the exemplary paddle-style medical lead of  FIGS. 6 and 7 . 
         FIG. 9  is an exploded, partial view of the exemplary paddle-style medical lead of  FIGS. 6-8 , illustrating the location of a butt joint joining the paddle with the lead body. 
         FIG. 10  is a perspective view of an exemplary center strut, which is one of two alternative preferred exemplary structures for use in the lead body of the medical lead of  FIGS. 6-9 . 
         FIG. 11  is a cross sectional view of the exemplary center strut of  FIG. 10 , illustrating aspects of a center strut. 
         FIG. 12  is a perspective view of an exemplary pentalumen tubing, which is the other of two alternative preferred exemplary structures for use in the lead body of the medical lead of  FIGS. 6-9 . 
         FIG. 13  is a cross sectional view of the exemplary pentalumen tubing of  FIG. 12 , illustrating aspects of pentalumen tubing. 
         FIG. 14  is a perspective view of an exemplary embodiment of an electrode and crimp tube for electrically connecting a conductor wire with the electrode. 
         FIG. 15  is an end view of the electrode and crimp tube of  FIG. 8 . 
         FIG. 16  is a back view of a second exemplary embodiment of an electrode with an integral crimp feature for connecting a conductor wire with the electrode. 
         FIG. 17  is an end view of the exemplary electrode of  FIG. 16 . 
         FIG. 18  is a perspective view of a half portion of an exemplary embodiment of the paddle, illustrating the connection of a conductor wire to the electrode via a crimp tube arranged along a lateral side of the electrode, the arrangement being such that tension tends to turn the electrode thus providing some additional strain relief. 
         FIG. 19  is a perspective view of two half portions of an exemplary embodiment of the paddle, illustrating aspects of assembly of the paddle. 
         FIG. 20  is a perspective view of the paddle with one half portion removed to illustrate passage of a stylet. 
         FIG. 21  is a perspective view of an exemplary embodiment of a conductor and crimp sleeve for use in connecting to a proximal contact. 
         FIG. 22  is a perspective view of an exemplary embodiment of a conductor and crimp sleeve of  FIG. 13  shown in relation with an exemplary proximal contact. 
         FIG. 23  is a perspective view of a second exemplary embodiment of a crimp sleeve for use in connecting a conductor to a proximal contact. 
         FIG. 24  is a perspective view of a second exemplary embodiment of a proximal contact for use with the exemplary crimp sleeve of  FIG. 23 . 
         FIGS. 25 and 26  are perspective views of an exemplary embodiments of a proximal area of a lead and the interface between the lead body and lead paddle, illustrating location of adhesive to minimize tensile loading of electrical conductors, contacts and electrodes. 
         FIG. 27  is a perspective view illustrating an exemplary embodiment of the assembly of a proximal contact on an exemplary embodiment of a center strut of a lead. 
         FIG. 28  is a perspective view illustrating electrically conductive proximal contacts separated by electrically insulative spacers. 
         FIG. 29  is a perspective view illustrating electrically conductive proximal contacts separated by electrically insulative spacers arranged on pentalumen tubing. 
         FIG. 30-33  are perspective views of an exemplary embodiment of an anchor for use with exemplary embodiments of the medical lead. 
         FIGS. 34 and 35  are perspective views of additional exemplary embodiments of an anchor for use with exemplary embodiments of the medical lead. 
         FIG. 36  is a perspective view of an exemplary embodiment of a needle, which has a flattened or oblong cross section for insertion of exemplary embodiments of the medical lead. 
         FIG. 37  is a vertical cross section view along a sagittal plane illustrating use of the needle of  FIG. 36  to place a lead epidurally. 
         FIG. 38  is a perspective view illustrating an exemplary embodiment of a stylet for use in the oblong needle of  FIGS. 36 and 37 . 
         FIG. 39  is a flow chart illustrating an exemplary embodiment of a method of percutaneously implanting a medical lead. 
     
    
    
     DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS 
       FIG. 1  is a schematic view of a patient  10  having an implant of a neurological stimulation system employing the present disclosure to stimulate spinal cord  12  of the patient. The preferred system employs implantable pulse generator (IPG)  14  to produce a number of independent stimulation pulses which are sent to spinal cord  12  by insulated lead  16  and coupled to the spinal cord by electrodes located at point  18 . An extension, which includes a conductor, may also be used to electrically connect the IPG to the lead  16 . 
     Implantable pulse generator  14  may be, for example, a neurostimulator, such as the neurostimulators available under the trade designations “Model 7425 Itrel™ 3 Neurostimulator” or “Model 7427 Synergy™ Neurostimulator,” both available from Medtronic, Inc., Minneapolis, Minn. Exemplary embodiments of such implantable pulse generators  14  typically include a battery or other power source, a processor, and a connector header for connection of a lead or lead extension to the IPG, as well as a telemetry antenna to allow communication with the IPG to or from an external device. 
     This exemplary system may employ a programmer  20 , which is coupled via conductor  22  to radio frequency antenna  24 . This permits attending medical personnel to select the various pulse output options after implant using radio frequency communications. While the exemplary system employs fully implanted elements, systems employing partially implanted generators and radio-frequency coupling may also practice the present disclosure. The system may also include a patient programmer (similar at the schematic level to the programmer  20 ) allowing the patient to select or modify the stimulation therapy program. 
     While the preferred exemplary system employs fully implanted elements, systems employing partially implanted generators and radio-frequency coupling may also be used (e.g., similar to products sold by Medtronic, Inc. under the trademarks X-trel and Mattrix). 
       FIGS. 2 and 3  illustrate details of spinal or vertebral anatomy, including connective tissue, such as the ligamentum flavum  30  ( FIG. 2 ) and the posterior epidural space  32  ( FIG. 3 ). 
     Exemplary embodiments of the medical lead  50  are adapted to be implanted through the ligamentum flavum  30  into the epidural space  32  into position for electrical spinal cord stimulation.  FIG. 2  also illustrates, among other things, the anterior longitudinal ligament  33 , intertransverse ligament  34 , interspinal ligament  35 , and supraspinal ligament  36 , and, of course, vertebra  37 .  FIG. 3  also illustrates, among other things, the spinal cord  38 , intrethecal space  39 , and anterior epidural space  40 . 
       FIGS. 4-8  show two exemplary embodiments of the paddle-style lead  50 . The medical lead  50  comprises a generally round or tubular lead body  52  having proximal and distal ends  54  and  56 , and at least one electrical conductor  58  (e.g., 4 or 8) extending between the proximal and distal ends. A connector or contact ring  60  is provided on the proximal end  54  of the lead body  52  in electrical communication with the electrical conductor  58 . A generally flat paddle  62  is provided on the distal end  56  of the lead body  52 . 
     An electrode array  64  is provided on the flat paddle  62  comprising at least one electrode  66  (e.g., four or eight electrodes) in electrical communication with the electrical conductor  58  (e.g., four or eight conductors corresponding to the number of electrodes). The paddle  62  has proximal and distal ends  68  and  70  and a length “L o ” extending between the proximal and distal ends. The electrode array  64  is displaced along the length of the paddle toward the distal end  70 . For example, the portion of the flat paddle proximal of the electrode array has a length L p  of at least 4 inches (100 mm), 3 inches (75 mm), 2 inches (50 mm) or 1½ inches (40 mm). 
     In one preferred exemplary embodiment, four conductors are provided with each comprising fluoropolymer insulated 0.005 diameter MP35N-Ag core cables. Four connectors or contact rings  58  may be configured to constitute, for example, an in-line cylindrical connector system for connection to a lead extension or IPG. Four electrodes may also be provided each comprising platinum/iridium. Such exemplary embodiments may have a total lead length of 25 cm to 100 cm, e.g., 30, 45 and 60 cm standardized lengths. Of course, other dimensions, materials and number of electrodes could be employed, and these are provided for purposes of illustration only. 
     One exemplary paddle  62  may have a nominal length of 8 inches (20 cm), nominal width of 0.15 inches (3.8 mm), and a nominal thickness of 0.04 inches (1 mm). The paddle  62  may be formed, for example, of material including polyurethane, and in one exemplary embodiment is formed of generally transparent polyurethane material. 
     The proximal end  68  of the flat paddle  62  preferably tapers down to the diameter of the lead body  52  as illustrated in  FIGS. 4 ,  5 ,  6  and  8 .  FIG. 9  illustrates the butt joint  69  that may be used between the paddle  62  and the lead body  52 . The butt bond  69  may be formed, for example, with urethane adhesive. 
     The electrodes  66  may be recessed relative to the surface of the paddle as illustrated in  FIG. 7 , or co-planer with the surface. Examples include recessing the electrode 0.010 inches (0.25 mm) from the surface with the electrode having a surface area of approximately 6 mm 2 . 
     An identification or orientation marker  67  ( FIGS. 6 and 8 ) may be provided on the paddle  62  to indicate to physicians which side of the electrode plate is exposed versus insulated during and after implant. This may be helpful, for example, to determine whether the lead  50  has flipped or twisted during implantation. For example, an orientation marker  67  for determining orientation of the lead  50  may include fluoroscopically viewable material, such as radio-opaque material (e.g., platinum or platinum/iridium alloy). Since the electrode array  64  of at least one exemplary embodiment of medical lead comprises electrodes  66  exposed only through the first major surface of the paddle  62 , the orientation marker  67  may be employed to provide a definite indication of the direction the paddle  62  (and electrode array  64 ) is facing. 
     For example, the paddle  62  may be considered as defining an imaginary longitudinal center line, and the orientation marker  67  may comprise a discrete radio-opaque marker  63  displaced from the longitudinal center line. When fluoroscopically viewing an implanted medical lead, the orientation of the paddle  62  may be determined by noting on which side of the imaginary center line the orientation marker  67  appears to be positioned. 
     In an exemplary embodiment, the orientation marker may comprise radio-opaque material arranged in an asymmetric manner with respect to the width of the paddle. As an alternative example of this embodiment, the orientation marker may comprise radio-opaque material dispersed in the paddle in an asymmetric manner with respect to the width of the paddle. Such radio-opaque material may be dispersed, for example, substantially uniformly in an asymmetric portion arranged asymmetrically with respect to the width of the paddle. The orientation of the implanted paddle may be determined by viewing an apparent asymmetric position of the orientation marker on the paddle, and determining, based on the apparent asymmetric position of the orientation marker, which direction the paddle is facing. 
     In a preferred exemplary embodiment, the orientation marker  67  is coded to identify the model or serial number of the lead  50 . The code would preferably be fluoroscopically visible after implantation of the lead  50 . 
     Exemplary embodiments of the lead body  52  preferably includes a center strut  53  as illustrated in  FIGS. 10 and 11 , or pentalumen tubing  55  as illustrated  FIGS. 12 and 13 . The exemplary center strut defines a central stylet lumen and longitudinally extending channels for receiving conductor wires. The exemplary pentalumn tubing defines a central stylet lumen and a plurality (e.g., 4) of longitudinally extending conductor lumens arranged radially outwardly from the central stylet lumen. 
       FIGS. 14-17  illustrate alternative preferred exemplary embodiments of means for electrically connecting a conductor wire to the electrode. The exemplary embodiment of  FIGS. 14 and 15  involve use of a connector  70  (e.g., crimp tube  70 ), which is crimped to the conductor and welded, e.g., laser welded) to the lateral edge of the electrode  66 . The exemplary embodiment of  FIGS. 16 and 17  involves a crimp connector  71  that is an integral part of the electrode  72 . The crimp connector  71  is shown in the form of a tab (also  71 ) that may be bent or crimped to connect the conductor to the electrode  72 . 
     The exemplary embodiments of the connection means illustrated in  FIGS. 14-17  are adapted to have strain or tension relief properties if the conductors are put under tension. Each of these means are illustrated as connecting the conductor to the lateral edge of the electrode  66  or  72  (relative to the longitudinal centerline of the paddle) such that tension along the conductor would tend to spin the electrode  66  or  72  thus tending to relieve such tension. 
     The paddle  62  may be formed of two half sections  74  and  76  (e.g., “lower” paddle half  74  and “upper” paddle half  76 ) as shown on  FIGS. 18-20 . For example, the half sections  70  and  72  may be formed of polyurethane. Electrode receiving apertures  78  may be provided (e.g., molded) in the lower paddle half  74 . Conductor wire paths  80  and stylet-lumen-forming channels  82  may be formed (e.g., molded) in one of both of the lower and upper paddle halves  74  and  76 . 
     The sections  74  and  76  are bonded together (e.g., with polyurethane adhesive) after assembly and connection (e.g., laser welding and/or crimping) of the electrodes  66  and conductors. The stylet-lumen forming channels  82  thus form a stylet lumen. 
       FIGS. 21 and 22  illustrate aspects of an exemplary embodiment of a crimp sleeve  84  for electrically connecting the proximal contacts  86  (e.g., contact ring) and conductor wires  88 . A miniature conductor  88  is crimped to the sleeve  84 , and the proximal contact  86  includes a slot  90  for receiving the crimp sleeve  84 . In at least one example, the sleeve  84  is then bent and its end flattened to match the slot  90  in the contact  86 , and the crimped cable/sleeve assembly is welded to the contact  86 . 
       FIGS. 23 and 24  illustrate aspects of a second preferred exemplary embodiment of a crimp sleeve  92  and proximal contact ring  94 . The contact ring  94  is generally cylindrical and has a longitudinal slot  96  for receiving the flared contact-connecting portion  98  of the crimp sleeve  92 , which may be welded, for example, in place. The crimp sleeve includes a conductor-wire-receiving channel  99 , which may be crimped to retain the conductor wire. Exemplary alternatives to the channel  99  include without limitation a crimp-able lumen (not shown). 
       FIG. 25  illustrates an example of where (e.g., at  100 ) the center strut  53  may be adhesively bonded to the proximal end of the paddle  62  (e.g., with urethane adhesive).  FIG. 27  illustrates the distal end  56  of the body portion  52 , which is bonded to the proximal end of the paddle at  100  in  FIG. 25 . 
       FIGS. 27-29  illustrate various exemplary details of the proximal contact portion and the assembly thereof. For example,  FIG. 27  illustrates assembly of proximal contacts  92  on a center strut  53  alternating with assembly of an electrically insulative urethane spacer  102 .  FIG. 29  illustrates an exemplary arrangement of proximal contacts  92  and urethane spacer  102  arranged on a pentalumen tube  55 . 
     An anchor, such as the anchor  104  illustrated in  FIGS. 30-33 , may be provided for clamping the flat paddle  62  and anchoring it to connective tissue, such as the ligamentum flavum  30 . For example, two clamping jaws  106  and  107  of the anchor  104  are adapted to clamp the major surfaces of the flat paddle  62 . One or both of the clamping arms  106  or  107  may be provided with at least one rib, but preferably a plurality of ribs  108  (e.g., 3), adapted to engage the flat paddle  62  and retain it in position. Suture loops  110  may be provided to suture the anchor  104  to connective tissue. The clamping arms  106  and  107  are preferably separable, with the clamping arms  106  and  107  being provided with mating knobs  112  and cavities  114  or other features for attaching the clamping arms  106  and  107  together. 
       FIGS. 34 and 35  illustrate alternative exemplary embodiments of an anchor  116  in which the halves or jaws  118  and  119  pivot relative to one another in a clam shell fashion to anchor the lead  50 . This embodiment may employ mating knobs and ribs as discussed with respect to the embodiment of  FIGS. 30-33 . 
       FIGS. 36-38  illustrate a preferred embodiment of a needle  200  and stylet  202  for use in exemplary embodiments of a procedure for introducing a paddle style lead  50  within the spinal column area, such as the epidural area, as depicted in  FIG. 37 . Alternative exemplary embodiments may into or near other nervous system structures, central or peripheral, such as intracranial nervous system structures or peripheral nerves. 
     As illustrated in  FIG. 37 , the needle assembly may be inserted into the spinal column area (e.g., epidurally). In an exemplary embodiment of the needle assembly, the lumen of the needle  200  has an oblong cross section sized to insert a paddle style lead  50  and has a curve at the distal end of the needle  200 . U.S. Pat. Nos. 6,249,707 and 6,309,401, and EP 1 048 270, are incorporated herein by reference in their entirety, and particular note is made of the flattened needle, which may be used with certain exemplary embodiments of the medical lead disclosed herein. 
     The needle  200  comprises a body having a proximal end  204  and a distal end  206  and an inside lumen  208 . The lumen  208  has an oblong cross section. The oblong cross section of the lumen  208  is adapted to receive a stylet  202  ( FIG. 30 ) and a paddle style lead  50 . The cross section of the lumen  208  is such that the width is greater than the height. A typical width for the lumen cavity to receive a paddle style lead  50  may be 2.5 mm to 12 mm (0.1″ to 0.5″) with a height of 1.4 mm to 2.0 mm (0.055″ to 0.079″). The needle  200  may be made of stainless steel or other suitable materials. The needle  200  may also be adapted to insert multiple wire leads. Advantageously, the present disclosure allows a paddle lead to be inserted percutaneously without requiring the lead  50  to be rolled/contorted to fit the geometry of the needle lumen  208 . 
     The needle  200  is further defined by an introducer portion (also  206 ) at the body distal end  206 . The introducer portion  206  has a top side and a bottom side is shaped to allow for penetration of a patient&#39;s skin and other tissue. Typically, an epidural, Tuohy or modified Tuohy needle may be used. The top side of the introducer portion  206  has an orifice to allow the paddle style lead  50  to exit the lumen  208  of the needle  200  within the spinal column area after insertion of the needle  200 . The introducer portion  206  may have the orifice at the distal end perpendicular to the lumen  208 . A preferred exemplary embodiment of the needle  200  has an introducer with a curvature. The curvature extends from the bottom side of the introducer  206  to the top side of the introducer to facilitate and guide the paddle style lead  50  during insertion. The radius of curvature for the introducer  206  may be, for example, approximately 0.9″. Other curvatures may also be used. 
       FIG. 38  illustrates a perspective view of the stylet  202  having a proximal end that is adapted to mate with the needle hub. The stylet  202  has a length nearly equivalent to the length of the body of the needle  200 . The stylet  202  has a distal tip shaped for matching with the orifice of the introducer of the needle  200 . A handle end is affixed to a proximal end of the stylet  202 . In the preferred embodiment, the stylet  202  fills the entire orifice of the introducer  206  to prevent any skin or other tissue from entering the lumen  208  during insertion within the patient. 
     In at least one preferred exemplary embodiment, the stylet  202  may be constructed of an elastomeric material, or deformable material that is sufficiently flexible and resilient or redeformable to allow the stylet  202  to be removed from the needle  200  even where the needle  200  has been subjected to plastic deformation. Alternatively, the stylet  202  may be formed of stainless steel. 
       FIG. 39  illustrates a general flow diagram of an exemplary preferred method  300  of use or implantation of the implantable paddle-style medical lead  50 . The method  300  generally follows these steps: make small incision  302 ; insert needle (with stylet) percutaneously through incision into the epidural space  304 ; remove stylet from needle  306 ; insert guidewire through needle to assess epidural space  308 ; insert lead through needle with electrodes down  310 ; remove needle  312 ; and anchor paddle of lead to connective tissue, such as ligamentum flavum  314 . 
     Thus, exemplary embodiments of the paddle-style medical lead and method are disclosed. One skilled in the art will appreciate that the present disclosure can be practiced with embodiments other than those disclosed. The disclosed embodiments are presented for purposes of illustration and not limitation, and the present disclosure is limited only by the claims that follow.