Patent Publication Number: US-8532788-B2

Title: Electrical stimulation lead with stiffeners having varying stiffness zones

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a divisional of U.S. application Ser. No. 12/416,813, filed Apr. 1, 2009, now U.S. Pat. No. 8,244,372, which claims the benefit of U.S. Provisional Application No. 61/041,386 filed Apr. 1, 2008, the disclosures of which are fully incorporated herein by reference. 
    
    
     TECHNICAL FIELD 
     The application is generally related to electrical stimulation leads for stimulation tissue of a patient and methods of their manufacture. 
     BACKGROUND 
     Neurostimulation systems are devices that generate electrical pulses and deliver the pulses to nerve tissue to treat a variety of disorders. Spinal cord stimulation (SCS) is an example of neurostimulation in which electrical pulses are delivered to nerve tissue in the spine typically for the purpose of chronic pain control. Other examples include deep brain stimulation, cortical stimulation, cochlear nerve stimulation, peripheral nerve stimulation, vagal nerve stimulation, sacral nerve stimulation, etc. While a precise understanding of the interaction between the applied electrical energy and the nervous tissue is not fully appreciated, it is known that application of an electrical field to spinal nervous tissue can effectively mask certain types of pain transmitted from regions of the body associated with the stimulated nerve tissue. Specifically, applying electrical energy to the spinal cord associated with regions of the body afflicted with chronic pain can induce “paresthesia” (a subjective sensation of numbness or tingling) in the afflicted bodily regions. Thereby, paresthesia can effectively mask the transmission of non-acute pain sensations to the brain. 
     Neurostimulation systems generally include a pulse generator and one or more leads. The pulse generator is typically implemented using a metallic housing that encloses circuitry for generating the electrical pulses, control circuitry, communication circuitry, a rechargeable battery, etc. The pulse generation circuitry is coupled to one or more stimulation leads through electrical connections provided in a “header” of the pulse generator. Specifically, feedthrough wires typically exit the metallic housing and enter into a header structure of a moldable material. Within the header structure, the feedthrough wires are electrically coupled to annular electrical connectors. The header structure holds the annular connectors in a fixed arrangement that corresponds to the arrangement of terminals on a stimulation lead. 
     The terminals of a stimulation lead are electrically coupled to the connectors within the header by manually pushing the proximal end of the stimulation lead into the header of the pulse generator. If the stimulation lead is improperly inserted into the header, the terminals of the stimulation lead will not be properly aligned with the connectors of the header and electrical pulses will not be properly conducted through the lead to electrodes for stimulation of tissue of the patient. 
     SUMMARY 
     In one embodiment, a neurostimulation lead comprises an elongated body of insulative material, comprising a first end portion and a second end portion; a plurality of terminals longitudinally positioned along the first end portion; a plurality of electrodes longitudinally positioned along the second end portion; a plurality of conductors electrically coupling the plurality of electrodes to the plurality of terminals; a flexible metal longitudinal stiffener positioned within the elongated body wherein the stiffener has a plurality of longitudinal zones and each zone has a different column strength, the column strength of one or more zones of the plurality of longitudinal zones being defined by cuts or gaps in the stiffener, the stiffener causing the neurostimulation lead to exhibit a greatest amount of column strength adjacent to one end portion of the elongated body and to transition to a lower column strength toward a medial portion of the elongated body. 
     The foregoing has outlined rather broadly certain features and/or technical advantages in order that the detailed description that follows may be better understood. Additional features and/or advantages will be described hereinafter which form the subject of the claims. It should be appreciated by those skilled in the art that the conception and specific embodiment disclosed may be readily utilized as a basis for modifying or designing other structures for carrying out the same purposes. It should also be realized by those skilled in the art that such equivalent constructions do not depart from the spirit and scope of the appended claims. The novel features, both as to organization and method of operation, together with further objects and advantages will be better understood from the following description when considered in connection with the accompanying figures. It is to be expressly understood, however, that each of the figures is provided for the purpose of illustration and description only and is not intended as a definition of the limits of the appended claims. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is an isometric view of a lead according to a representative embodiment. 
         FIG. 2  is a side view illustrating the lead of  FIG. 1  coupled to a pulse generator. 
         FIG. 3   a  is a detailed isometric view of an exemplary proximal stiffener incorporating certain disclosed embodiments. 
         FIG. 3   b  is a detailed isometric view of an exemplary distal stiffener incorporating certain disclosed embodiments. 
         FIG. 4   a  is a side view of an exemplary stiffener incorporating certain disclosed embodiments. 
         FIG. 4   b  is an isometric view of the exemplary stiffener of  FIG. 4   a.    
         FIG. 5   a  is a side view of an exemplary stiffener incorporating certain disclosed embodiments. 
         FIG. 5   b  is an isometric view of the exemplary stiffener of  FIG. 5   a.    
         FIG. 6   a  is a side view of an exemplary stiffener incorporating certain disclosed embodiments. 
         FIG. 6   b  is an isometric view of the exemplary stiffener of  FIG. 6   a.    
         FIG. 7  is a flow chart illustrating a process of making certain disclosed embodiments. 
     
    
    
     DETAILED DESCRIPTION 
     For the purposes of promoting an understanding of the principles of the present application, reference will now be made to the embodiments, or examples, illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the claims is thereby intended. Any alterations and further modifications in the described embodiments, and any further applications of the principles of the embodiments as described herein are contemplated as would normally occur to one skilled in the art to which the application relates. 
     Turning now to  FIG. 1 , there is presented one representative embodiment of a lead  100 . As will be explained below, the lead  100  is generally configured to transmit one or more electrical pulses from a pulse generator to a spinal nerve, a peripheral nerve, or other tissue. The lead  100  comprises a proximal end  102  and a distal end  104 . The lead  100  further comprises a flexible lead body  106  that extends from proximal end  102  to the distal end  104 . As will be explained in detail later, in certain embodiments, the lead body  106  may be formed of relatively soft and compliant insulating materials such as silicone, polyurethane, polyethylene, polyamide, polyvinylchloride, PTFE, EFTE, or other suitable materials known to those skilled in the art. In certain embodiments, one or more lumens (not shown) may extend through the lead body  106  and, as will be explained later, may be used for housing one or more stiffeners or stiffening stylettes. In the illustrative embodiment, there is a proximal end stiffener  108  and a distal end stiffener  110  positioned within lumen(s) (not shown) of the lead body  106 . 
     Adjacent to distal end  104  of lead  100  is a stimulation electrode region  112  comprising, in this embodiment, eight stimulation electrodes  114 . Adjacent to proximal end  102  of lead  100  is a connector region  116  that, in this embodiment, comprises eight terminals  118 . For purposes of illustration only, the lead  100  of  FIG. 1  is shown with eight stimulation and eight terminals. As will be appreciated by those skilled in the art, any number of conductors, terminals, and electrodes may be utilized as desired to form lead  100 . Generally, some embodiments have the same number of stimulation electrodes as terminals. In this illustrative embodiment, the stimulation electrodes and terminals are shown as metallic bands or rings. 
     One or more conductors (not shown) extending along a substantial portion of the lead body  106  electrically connect the terminals  118  to the stimulation electrodes  114 . Although lead  100  is described as being adapted for neurostimulation according to some embodiments, lead  100  can be utilized for any suitable type of stimulation therapy, sensing application, or other medical application, such as functional electrical stimulation, cardiac stimulation, tissue ablation, gastric pacing, etc. 
       FIG. 2  illustrates the lead  100  connected to implantable pulse generator (IPG)  120  via a receptacle  122 . As is well known in the art, an implantable pulse generator (IPG) is intended to be implanted within the body of a patient to provide electrical stimulation to treat chronic pain or another condition of the patient. An exemplary implantable pulse generator is the EON® pulse generator available from Advanced Neuromodulation Systems, Inc. 
     In this illustrative example, the lead  100  is connected to the implantable pulse generator  120  via the receptacle  122 . The lead  100  may be detached from the pulse generator  120  as desired by applying a detaching force and removing proximal end  102  of the lead  100  from the receptacle  122 . Similarly, the lead  100  may be connected to the pulse generator  120  by pushing the proximal end  102  into the receptacle  122 . 
     As illustrated, the terminals  118  are in electrical contact with electrical connectors (not shown) within a header  123  of the pulse generator  120 . A plurality of feedthrough wires (not shown) connect the electrical connectors to pulse generating circuitry (not shown) within the pulse generator  120 . The pulse generator  120  sends electrical pulses to the electrical connectors, which are in electrical contact with the terminals  118 . As previously discussed, the terminals  118  are themselves in electrical contact with the stimulation electrodes  114  at distal end of lead  100  because conductors (not shown) electrically connect the terminals  118  with the stimulation electrodes  114 . 
     Thus, the pulse generator  120  may generate and send electrical pulses via the lead  100  to the stimulation electrodes  114 . In use, the stimulation electrodes  114  are placed at a stimulation site (not shown) adjacent to tissue of the patient suitable for electrical stimulation. The stimulation site may be located within the epidural space as one example. The pulse generator  120  generates and delivers the electrical pulses to one or more selected electrodes according to various stimulation parameters (e.g., pulse amplitude, pulse width, pulse frequency, electrode polarity, etc.). In certain embodiments, the pulse generator  120  receives the stimulation parameters and other control signals via wireless communication with an external programming device (not shown). 
     Turning now to  FIG. 3   a , there is illustrated an isometric view of the proximal end  102  of the lead  100  with the lead body  106  and conductors removed for clarity. In this view, the stiffener  108  is shown as a tube  124  having a proximal end portion  126  and a distal end portion  128 . The tube  124  could be made of Nitinol, stainless steel or other bio-compatible materials. Tube  124  preferably possesses a substantially constant diameter along its length. Although the tube  124  is used in this description, in other embodiments, the stiffener could be formed from a rod, wire or other longitudinal member having a variety of different cross sectional shapes. 
     At the distal end portion  128 , there is a spiral cut  130  through the walls of the tube  124 . As will be discussed later, the pitch of the spiral cut  130  varies as the spiral cut progresses from a distal end  132  of the spiral cut towards the proximal end  134  of the spiral cut. In this illustrative example, the pitch of the spiral cut  130  is greater towards the distal end  132  and decreases as the spiral cut progress towards its proximal end  134 . This varying pitch, in turn, affects and varies the overall column strength of the tube  124  in the region of the spiral cut  130 . As the pitch increases, the corresponding resistance to lateral and/or axial buckling for that portion of the tube  124  decreases. For purposes of this application, resistance to lateral and/or axial buckling within a given longitudinal length will be defined to be “column strength.” For tubular structures having spiral cuts, the column strength is a function of the remaining cross section area of the tube, the diameter of the tube, and the pitch of the spiral cut. 
     From an end user&#39;s perspective, a higher column strength increases the “pushability” of the stiffener  108  and decreases the “flexibility” of the stiffener. The flexibility of the tube portion is inversely proportional to the column strength. In this example, therefore, the flexibility of the tube  124  increases towards the distal end  132  and decreases towards the proximal end  134  of the spiral cut  130 . 
     In the illustrative example, the portion of the tube  124  that runs from its distal end  132  to the proximal end  134  of the spiral cut  130  is free of any cuts in its sidewalls, and thus, has a maximum cross sectional area. The tube  124 , therefore, has its greatest column strength in this “solid” region, which also includes the connector region  116  of the lead  100  (See  FIG. 1 ). So, in this example, the stiffener  108  may be thought of having at least two longitudinal zones. The first zone having a constant column strength (from the proximal end  126  of the tube  124  to the proximal end  134  of the spiral cut  130 ). The second zone is a longitudinal region having a reduced column strength. In the illustrative example, there are additional longitudinal zones of different column strengths which correspond to the varying change in pitch of the spiral cut  130 . 
     This relatively large column strength of the first zone is advantageous because it allows a user to easily insert the proximal end  102  of the lead  100  into the receptacle  122  ( FIG. 2 ) without excessive buckling. Without a stiffener, and especially for a stimulation lead having a highly compliant lead body (see U.S. Publication No. 2007/0282411), the lead  100  would tend to buckle more easily and insertion into the receptacle would be more difficult. Also, a relatively small implantable pulse generator adapted to accept a small diameter lead presents further difficulty for the proper insertion of the lead into the header of the generator. Such difficulties may potentially cause terminals of lead  100  to improperly couple or not couple at all to the electrical connectors within the header of pulse generator  120 . Also, if a stiffener had a constant column strength throughout its length, the stiffener would create a stress point at its distal end of the stiffener within the relatively soft and compliant material of the lead body  106  ( FIG. 1 ). A stress point is created in the lead  100  when there is an abrupt change in stiffness in a portion of the lead  100  where the relatively greater stiffness of a solid tube or wire meet a portion of the lead body  106  made from compliant material. The stress point could lead to material failure of the lead body  106  and/or patient discomfort. 
     A stiffener having at least two zones of stiffness or column strength could provide the required column strength to help insert the proximal end  102  of the lead  100  into the receptacle  122  and may have the flexibility to reduce any stress points which typically occurs within the lead body  106  if a constant column strength tube were used. A stiffener with only two zones of stiffness would provide two stress points (around the point where change in stiffness occurs and at the distal end). The magnitude of material stress within these two stress points would be significantly reduced when compared to the configuration having a single stress point. Similarly, a stiffener with multiple or varying zones of stiffness allows a gradual transition—which effectively eliminates and/or greatly reduces the magnitude of material stress within any stress points. 
     In sum, the proximal lead stiffener  108  provides a maximum column strength in one zone from the proximal end  126  of the tube  124  to the proximal end  134  of the spiral cut  130 , which allows for easy insertion into a receptacle. In the second region from the proximal end  134  to the distal end  132 , there are additional zones where the column strength is gradually reduced to eliminate or greatly reduce any stress points within the lead body  106 . 
       FIG. 3   b  is a detailed isometric view of the distal end portion  140  of the lead  100  with the lead body  106  and conductors removed for clarity. In this view, the distal end stiffener  110  is shown as a tube  136  having a proximal end portion  138  and a distal end portion  140 . The tube  136  could be made of Nitinol, stainless steel or other bio-compatible materials. In this illustrative embodiment, there is a spiral cut  142  through the walls of the tube  136 . The pitch of the spiral cut  142  may vary along the longitudinal length of the spiral cut  142 . In this illustrative example, the pitch of the spiral cut  142  may be greater towards the proximal end portion  138  and decreases as the spiral cut progress towards the distal end portion  140 . 
     As explained above, this varying pitch affects and varies the overall column strength of the tube  136  in the region of the spiral cut  142 . As the pitch increases, the corresponding column strength for that portion of the tube  136  decreases. Similarly, the flexibility of the tube portion increases because the flexibility is inversely proportional to the column strength. Thus, by varying the pitch of the spiral cut  142 , the tube  136  may have different longitudinal portions or zones in which each zone has a unique column strength. Furthermore, the zones could vary from stiff to flexible to stiff, etc. depending on the application. For instance, in the region of the proximal end  138 , there may be one or more zones having a relatively reduced column strength to reduce stress points in the lead body  106  ( FIG. 1 ) as described above. In other zones within the stimulation electrode region  112 , the column strength could increase or vary to make implantation easier for the surgeon or to correspond with anatomical features of the application and/or patient. For example, the distal end stiffener  110  may be five longitudinal zones, where each zone has a different column strength corresponding to surgical implantation techniques and patient anatomy. 
     Turning now to  FIG. 4   a , there is a side view of an example embodiment of a stiffener  144 .  FIG. 4   b  is an isometric view of the example embodiment  144 . As illustrated, the stiffener  144  has six longitudinal zones  146  to  152  of varying column strength created a spiral cut  154  (or lack thereof). In this example, the pitch of the spiral cut is maximum in the zone  151  (for example 0.02) and is minimum in the zone  147  (for example 0.04). There is no cut in zone  146  and the tip portion  152 . Thus, the column strength of the stiffener is maximum in zone  146 , relatively stiff in zone  147  and is minimum in zone  151 . Such a configuration could be used for a proximal end stiffener of a lead as discussed previously. 
     Although a spiral having varying pitch cut in a tube is but one example of a stiffener having a variable column strength, other implementations are possible to provide variable column strength. For example, stiffeners having varying stiffness zones could also be created by using different patterns of cuts or slots formed in the longitudinal member. The stiffener shown in  FIGS. 5   a  and  5   b  is one such example. 
       FIG. 5   a  is a side view of another embodiment of a stiffener  156 .  FIG. 5   b  is an isometric view of the stiffener  156 . In this example embodiment, the column strength varies due a series of alternating lateral cuts or slots made within the walls of a tube  158 . In this example embodiment, the stiffener  156  has five longitudinal zones  160  to  164  of varying column strength created by a change in spacing of the lateral cuts. As illustrated in  FIG. 5   b , there may be a first series of lateral slots or cuts  166  and a second series of opposing cuts  168  positioned across from the lateral cuts  166  (forming a first plurality of pairs of opposing later cuts). Longitudinally spaced within the series of lateral cuts  166  and  168 , there may be another series of interspersed cuts  170  and a corresponding series of opposing lateral cuts  172  forming a second plurality of pairs of opposing lateral cuts. In certain embodiments, the lateral cuts  170  and  172  may be orientated substantially perpendicular to the lateral cuts  166  and  168 . In other embodiments, the lateral cuts could be orientated at other angles or angles which vary along the length of the stiffener  156 . 
     In this example, the spacing of the lateral cuts is maximum in the zone  163  (for example 0.02 inch) and is minimum in the zone  161  (for example 0.03 inch). In this embodiment, zone  162  is a transition zone. Furthermore, there are no cuts in zone  160  and the tip portion  164 . Thus, the column strength of the stiffener  156  is maximum in zone  160 , relatively stiff in zone  161  and is minimum in zone  163 . Such a configuration could also be used for a proximal end stiffener of a lead as discussed previously. 
     Turning now to  FIG. 6   a , there is a side view of an example embodiment of a stiffener  180  which may be used at a distal end of a lead.  FIG. 6   b  is an isometric view of the example embodiment  180 . As illustrated, the stiffener  180  has five longitudinal zones  182  to  186  of varying column strength created a spiral cut  188  (or lack thereof). In this example, however, the pitch of the spiral cut  188  varies within certain longitudinal zones. 
     In certain embodiments, there is no cut in the end portions (zone  182  and the tip portion  186 ). In zone  183 , the pitch of the spiral cut  188  varies from a lesser value at a proximal end  190  of the zone to a greater value at a distal end  192  of the zone. In zone  184 , the pitch may remain constant. In zone  185 , the pitch of the spiral cut  188  may vary from a greater value at the proximal end  194  to a lesser value at the distal end  196  of the zone. Consequently, the column strength of the stiffener  188  is maximum in zones  182  and  186 . In zone  183 , the column strength varies from a relatively low value at the proximal end  190  of the zone to a relatively high value at the distal end  192 . The column strength remains constant in zone  184 . In zone  185 , the column strength varies from a relatively higher value at the proximal end  194  of zone  185  to a lower value at the distal end  196 . 
     Such a configuration for a distal end stimulation stiffener may keep the lead from buckling when implanted in the dorsal column due to gravity or patient movements. In some embodiments, the stimulation end stiffener may also reduce the likelihood of lead buckling off the needle during implant and pushing. In certain embodiments, the stimulation end stiffener may make it easier to steer the lead. In certain regions, the column strength of the end of the lead may be weaker so that it compliments and complies with the bend of the stylet. 
     The stiffener  180  may be dimensioned to conform to the anatomy of a patient. By way of an illustrating example, in a certain embodiment of a tubular stiffener made from a superelastic Nitinol alloy having a similar configuration to that illustrated in  FIGS. 6   a  and  6   b , the overall length of the stiffener could be approximately 7.8 inches. The exterior diameter of the stiffener may be 0.021″ and an interior diameter of 0.017.″ In such an example, the spiral cut  188  may have a width of 0.003″. The zone  183  may have a length of approximately 1.96 inches. The pitch of the spiral cut  188  may vary from 0.02″ inches at the proximal end  190  of the zone  183  to 0.08″ at the distal end  192  of the zone. The pitch of the spiral cut  188  in zone  184  may be 0.1″. In zone  185 , the pitch of the spiral cut  188  may vary from 0.08″ at the proximal end  194  of the zone to 0.02″ at the distal end  196  of the zone. The foregoing dimensions are provided by way of example only, and are not meant to limit the scope of the present invention in any manner. 
     Various methods of making lead bodies with conductors are known in the art. Certain methods of making a lead body with conductors are disclosed in U.S. Publication No. 2005/00027340, entitled “System and Method for Providing a Medical Lead Body having Dual Conductor Layers, ” filed on Jul. 29, 2003 and in U.S. Pat. No. 6,216,045, entitled “Implantable Lead and Method of Manufacture, ” filed on Apr. 26, 1999, the disclosures of which are hereby incorporated by reference for all purposes. In one embodiment, the stimulation lead is adapted to exhibit appreciable elongation under relatively low stretching forces. For example, the stimulation lead may be adapted to elongate at least 15%, 25%, or more when a relatively low stretching force (e.g., 1 or 2 pounds or less) is applied to the lead. Fabrication of stimulation leads adapted in this manner is described in U.S. Publication No. 2007/0282411 entitled “Compliant Electrical Stimulation Leads and Methods of Fabrication,” filed on Mar. 30, 2007, the disclosure of which is incorporated herein by reference for all purposes. 
       FIG. 7  is a process flow chart illustrating one embodiment of a method  700  for making a lead incorporating various features discussed above. The process begins at step  701 . In step  702 , an inner layer of extrusion material may be placed on a mandrel to begin forming the lead body. A plurality of conductors may be provided where each conductor is coated with extrusion material. Each coated conductor may be wrapped around the inner layer of the extrusion material on the mandrel (step  704 ). An outer layer of extrusion material may then be placed over the plurality of conductors (step  706 ). Heat shrink tubing is then placed over the outer layer and the lead body assembly may be heated to melt the extrusion material. The melted extrusion material is compressed around the plurality of conductors as the heat shrink tubing shrinks. The lead body may then be cooled and the heat shrink tubing may be removed. The solidified extrusion material forms the lead body. The lead body may then be removed from the mandrel which leaves a longitudinal lumen in the lead body (step  708 ). 
     In step  710 , stiffeners incorporating various aspects disclosed above may now be inserted into the longitudinal lumen. In certain embodiments, the stiffeners may be inserted into both the proximal ends and the distal ends. In other embodiments, a stiffener may only be inserted into either the proximal or distal end depending on the application for the lead. 
     In step  712 , the conductors may be prepared to electrically connect with electrodes. Such preparation may include laser ablating the electrode sites on the proximal and distal ends of the lead body. Once the sites are ablated, the conductors may be pulled to the surface. 
     In some embodiments, distal ends of a plurality of ribbons corresponding to the number of electrodes may be laser welded to conductors at the electrode sites. (step  714 ). In certain embodiments, the electrodes may now be slid over the ribbons. In step  716 , the stiffener depth may now be adjusted. The electrodes may then be longitudinally positioned along the lead body (step  718 ). In certain embodiments, a fixture indicating the proper spacing may be used. Once in place, the electrodes may be pre-crimped. 
     The electrodes may then be swaged onto the lead (step  720 ). The stiffener provides a solid center which provides the necessary compression needed to swage the respective electrode over the lead body. After the electrodes are compressed by the swaging, the proximal ends of each ribbon may be welded to an edge of a corresponding electrode (step  722 ). In step  724 , additional extrusion material may then be placed over the proximal and distal ends of the lead. The leads may then be annealed (step  726 ). In step  728 , final preparation of the leads, including various testing, may then be accomplished using methods known to those skilled in the art. In certain embodiments, the process ends at step  730 . 
     In some embodiments, therefore, leads may be manufactured integral with stiffeners having varying zones of stiffness. When used as described in the above manufacturing process, such stiffeners provide the necessary compression force to allow swaging of the electrodes to the leads while reducing the likelihood of undesirable stress points developing within the lead at a later point in time. 
     In other embodiments, electrodes may be coupled to the leads using other methods known to those skilled in the art. In such embodiments, stiffeners having varying zones of stiffness may be used to enhance the steerability of the lead during implantation or during coupling of the lead to the pulse generator. In such embodiments, the leads do not have to be formed integral with the stiffeners. The stiffeners may be inserted into the central lumen of the lead at a later time. 
     In certain embodiments, the leads and stiffeners could be provided as part of a kit. In such embodiments, the leads may have a proximal stiffener to aid in the coupling of the lead to a pulse generator. The leads may also be supplied with a plurality of stiffeners, where each stiffener has different length longitudinal zones of stiffness corresponding to the likely sizes and shapes of patient anatomy. In certain embodiments, a plurality of stylets may also be used with a single stiffener. For instance, the stylets may be used in conjunction with a distal end stiffener and may have complimentary structural properties. The stylets may have longitudinal stiffness zones which are designed to compliment the longitudinal stiffness zones of the corresponding stiffeners to increase steerability during implantation. Upon removal of the stylet, the end stiffener may then have longitudinal stiffness zones which closely correspond with a patient&#39;s anatomy to reduce buckling during use. Such a kit would allow a surgeon to have greater flexibility in choosing the correct stiffener and stylet to use in an individual patient. 
     Once implanted, various disclosed embodiments of the distal end stimulation stiffener may keep the lead from buckling when implanted in the dorsal column due to gravity or patient movements. Specifically, in the space between the distal stimulation end and an anchor. Buckling in this area is undesirable because if the lead buckles, the stimulation end will lose its position and the effectiveness of stimulation may be diminished. In some embodiments, the stimulation end stiffener may also reduce the likelihood of lead buckling off the needle during implant and pushing. In certain embodiments, the stimulation end stiffener may make it easier to steer the lead. In certain regions, the column strength of the end of the lead may be weaker so that it compliments and complies with the bent of the stylet. Additionally, various embodiments of the stimulation end stiffener may assist the physician to steer through impediments or obstructions during the implantation procedure. 
     Any advantages and benefits described above may not apply to all embodiments of the invention and may not apply to all of the claims. The foregoing description of the embodiments of the invention has been presented for the purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed. Many combinations, modifications and variations are possible in light of the above teaching. Undescribed embodiments which have interchanged components are still within the scope of the present invention. It is intended that the scope of the invention be limited not by this detailed description, but rather by the claims appended hereto. 
     The abstract of the disclosure is provided for the sole reason of complying with the rules requiring an abstract, which will allow a searcher to quickly ascertain the subject matter of the technical disclosure of any patent issued from this disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims.