Abstract:
A device for introduction into a body vessel includes a shaft, a balloon positioned at the distal end of the shaft, a guidewire disposed longitudinally within the shaft to receive a guidewire during use, a balloon disposed at the distal end of the shaft, and longitudinal scoring wires to score a vascular lesion attached to the distal end of the shaft, disposed over the balloon and disposed within the shaft. The proximal ends are welded or otherwise affixed to a spring mounted in the handle. The balloon expands when fluid is delivered to the balloon through the inflation lumen. This expansion pushes the scoring wires against the vascular lesion.

Description:
BACKGROUND OF THE INVENTION 
       [0001]    Balloon dilatation catheters are used to treat lesions in vessels. However, difficulties are encountered in navigating tortuous anatomy and safely crossing very tight lesions. Moreover, some lesions are difficult to dilate using just a balloon, and require a focused force to dilate the lesion at safe inflation pressures. 
         [0002]    U.S. Pat. No. 6,394,995 to Solar et al. describes a system used to provide enhanced force to treat a lesion. This system has a flexible advancement member with a tracking member slidable over a guidewire, and a balloon having a distal end attached to the tracking member. But this type of system provides limited focused force and lacks pushability and maneuverability. 
       SUMMARY OF THE INVENTION 
       [0003]    The present invention provides a scoring balloon catheter that can be used for treating vascular lesions. In use, the balloon presses scoring wires into the lesion. The catheter includes a shaft; an inflatable balloon mounted on the shaft&#39;s distal section; a member or spring associated with the shaft, proximal to the balloon; and at least one scoring wire. In some embodiments the scoring wire has a fixed end mounted on the shaft between the shaft&#39;s distal end and the balloon. The scoring wire has a longitudinally movable end associated with the member or spring; and an intermediate portion disposed outside of the balloon. 
         [0004]    In some embodiments the movable scoring-wire ends are the proximal ends of the wires. These ends extend into lumens in the member. In some of these embodiments, the member comprises or interacts with a longitudinally resilient member such as an elastic polymer or rubber or a spring. In some embodiments, the device further comprises a second member in which the spring sits between the member and the second member. 
         [0005]    In some embodiments, the device comprises scoring wire lumens inside or outside of the shaft. These scoring wire lumens contain one or more scoring wires. In some embodiments, the device comprises two lumens inside of the shaft and two scoring wires inside of the lumens. 
         [0006]    In other embodiments, the scoring balloon catheter uses a spring mounted within a hub on a handle assembly. The shaft passes through the spring and extends into the handle assembly. A hub cover sits over the shaft and over the hub. In some cases, the hub cover provides strain relieve to the hub-spring connection. The scoring wires are welded or otherwise attached to the spring. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0007]    The above and further advantages of the present invention may be better understood by referring to the following description in conjunction with the accompanying drawings in which: 
           [0008]      FIG. 1 a    is a front view of an example of an invention device. 
           [0009]      FIG. 1 b    is a magnified view of the indicated portion of  FIG. 1   a.    
           [0010]      FIG. 1 c    is a magnified view of the indicated portion of  FIG. 1   a.    
           [0011]      FIG. 2 a    is a front view of another example of an invention device. 
           [0012]      FIG. 2 b    is a magnified view of the indicated portion of  FIG. 2   a.    
           [0013]      FIG. 2 c    is a magnified view of the indicated portion of  FIG. 2   a.    
           [0014]      FIG. 3 a    is a front view of another example of an invention device. 
           [0015]      FIG. 3 b    is a magnified view of the indicated portion of  FIG. 3   a.    
           [0016]      FIG. 3 c    is a magnified view of the indicated portion of  FIG. 3   a.    
           [0017]      FIG. 4 a    is a front view of another example of an invention device. 
           [0018]      FIG. 4 b    is a magnified view of the indicated portion of  FIG. 4   a.    
           [0019]      FIG. 4 c    is a magnified view of the indicated portion of  FIG. 4   a.    
           [0020]      FIG. 5 a    is a front view of another example of an invention device. 
           [0021]      FIG. 5 b    is a magnified view of the indicated portion of  FIG. 5   a.    
           [0022]      FIG. 5 c    is a magnified view of the indicated portion of  FIG. 5   a.    
           [0023]      FIG. 6  is a front view of another embodiment of an invention device. 
           [0024]      FIG. 7 a    is an end view showing the embodiment of  FIG. 1  at section plane AA. 
           [0025]      FIG. 7 b    is similar to  FIG. 7 a    viewing section plane AA on a different invention embodiment. 
           [0026]      FIG. 8 a    is an end view showing an embodiment of the device taken along a section plane similar to section plane BB. 
           [0027]      FIG. 8 b    is similar to  FIG. 8 a    viewing section plane AA on a different invention embodiment. 
           [0028]      FIG. 9  is an end view of the device of  FIG. 6 . 
       
    
    
       [0029]    The drawings are not necessarily drawn proportionally or to scale. For example, the dimensions of some of the elements may be exaggerated relative to other elements for clarity or several physical components may be included in one functional block or element. Further, sometimes reference numerals may be repeated among the drawings to indicate corresponding or analogous elements. Moreover, some of the blocks depicted in the drawings may be combined into a single function. 
       DETAILED DESCRIPTION 
       [0030]    In the following detailed description, numerous specific details are set forth to provide a thorough understanding of the present invention. Those of ordinary skill in the art will know that the present invention may be practiced without these specific details. In other instances, well-known methods, procedures, components, or structures may not have been described in detail so as not to obscure the present invention. 
         [0031]    The present invention is directed to systems and methods for treatment of a vessel. The principles and operation of systems and methods of the present invention may be better understood with reference to the drawings and accompanying descriptions. 
         [0032]    The invention is not limited in its application to the details of construction and the arrangement of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein are for the purpose of description and should not be regarded as limiting. 
         [0033]    Certain features of the invention that are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention that are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination. 
         [0000]    
       
         
               
             
               
               
             
           
               
                   
               
               
                 Table of components. 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                 100 
                 scoring balloon (SCB) catheter 
               
               
                 105 
                 shaft 
               
               
                 106 
                 shaft proximal section 
               
               
                 107 
                 shaft middle section 
               
               
                 108 
                 shaft distal section 
               
               
                 109 
                 shaft wall 
               
               
                 110 
                 shaft distal end 
               
               
                 111 
                 shaft tapered section 
               
               
                 112 
                 shaft proximal end 
               
               
                 113 
                 shaft lumen 
               
               
                 115 
                 inflatable balloon (IB) 
               
               
                 119 
                 guidewire lumen (GWL) 
               
               
                 120 
                 GWL distal end 
               
               
                 121 
                 GWL outer surface 
               
               
                 130 
                 IB proximal end 
               
               
                 131 
                 IB distal end 
               
               
                 132 
                 IB outer surface 
               
               
                 133 
                 IB lumen 
               
               
                 135 
                 scoring wire (SCW) 
               
               
                 1351 
                 SCW distal section 
               
               
                 1352 
                 SCW proximal section 
               
               
                 136 
                 fixed SCW end 
               
               
                 1361 
                 SCW lumen section 
               
               
                 1362 
                 weld joint 
               
               
                 137 
                 SCW IB section 
               
               
                 138 
                 moveable SCW end 
               
               
                 1139 
                 SCW lumen 
               
               
                 140 
                 Hub 
               
               
                 141 
                 GWL passage 
               
               
                 145 
                 Hub lumen 
               
               
                 150 
                 handle assembly (HA) 
               
               
                 153 
                 HA IB lumen port 
               
               
                 154 
                 HA GW port 
               
               
                 155 
                 HA distal end point 
               
               
                 156 
                 HA stepped-down portion 
               
               
                 200 
                 spring 
               
               
                 201 
                 spring wire 
               
               
                 241 
                 Hub distal section 
               
               
                 242 
                 hub proximal section 
               
               
                 340 
                 narrowed region 
               
               
                 400 
                 fingergrip 
               
               
                 451 
                 extension 
               
               
                 505 
                 SCW cross-section 
               
               
                 610 
                 see IBL 
               
               
                 700 
                 Hub cover 
               
               
                   
               
             
          
         
       
     
       DEFINITIONS 
       [0034]    “fixed”—inseparable within the operational environment of the device. 
         [0035]    “operational environment”—any environment in which the device would conceivably operate as an intravascular balloon catheter. 
         [0036]    “longitudinally resilient”—the ability to repeatedly move longitudinally. 
         [0037]    “definition of mechanically communicating”—describes the ability of one object to connect sufficiently such that its movement causes another object to move and vice versa. 
         [0038]    “rail”—A substantially longitudinal object that supports and guides the movement of another object. 
         [0039]    A “slidably engaged” component is a component that fits into a passageway or around a rail such that the component is largely or substantially constrained in two dimensions. Instead of the third dimension constraining the component, the component is unconstrained to some degree allowing the component to move longitudinally a substantial distance within the passageway or along the rail. If the system has stops or other components that curtail longitudinal movement, but still permit substantial longitudinal motion, the component is considered slidably engaged. 
         [0040]    “effectively engaged”—a scoring wire is effectively engaged when it engages the lesion well enough for the treatment to substantially affect the lesion. 
         [0041]    Invention catheters can be over-the-wire, short rapid exchange, or rapid exchange platform. If the catheter is a short rapid exchange platform, an inner member may traverse the entire length of the catheter. 
         [0042]    Turning to the invention embodiments,  FIG. 1 a    depicts an embodiment of the invention device. In this invention embodiment, a scoring balloon (SCB) catheter  100  is shown in a front view with selected sections shown in a magnified view. SCB catheter  100  comprises components as discussed below. For instance, catheter  100  comprises shaft  105 . Shaft  105  has shaft proximal section  106  connected to shaft middle section  107  and shaft middle section  107  connected to shaft distal section  108 . Shaft tapered section  111  joins shaft proximal section  106  to shaft middle section  107 . Shaft  105  also comprises shaft wall  109 , which provides a degree of rigidity to shaft  105  such that shaft  105  is suitable (as judged by those of ordinary skill in the art) for tracking into vasculature or tortuous vasculature being neither too rigid or too flexible. In some embodiments, the rigidity or flexibility is modified by adding a longitudinal member (not shown) to SCB catheter  100 . Shaft  105  comprises Pebax, in some embodiments. 
         [0043]    In some embodiments, shaft tapered section  111  is fixed to shaft middle section  107 . In some embodiments, shaft wall  109  ends before shaft distal end  110  ends. 
         [0044]    For purposes of this document, shaft distal end  110  is the end of shaft  105  that enters the patient first. Similarly, any other “distal”-characterized component means the component portion closer to shaft distal end  110  then is any other component portion. Likewise, any “proximal”-characterized component means the component portion further from shaft distal end  110  then is any other component portion. 
         [0045]    SCB catheter  100  further comprises inflatable balloon (IB)  115 . Inflatable balloon  115  mounts to shaft  105  within shaft distal section  108 . In some embodiments, inflatable balloon  115  ends at shaft distal end  110 . In these or other embodiments, inflatable balloon  115  is fixed to shaft  105 . 
         [0046]    Inflatable balloon  115  comprises IB proximal end  130  and IB distal end  131 . A typical embodiment has a flexible, polymeric film serving as inflatable balloon  115 . IB outer surface  132  ends up facing abluminally after inflatable balloon  115  mounts to shaft  105 . For this disclosure, IB proximal end  130  is the portion of inflatable balloon  115  that attaches or fixes the proximal end of inflatable balloon  115  to shaft  105 . IB proximal end  130  is defined as the proximal portion of inflatable balloon  115  that remains contacting shaft  105  after inflatable balloon  115  is inflated. 
         [0047]    For this disclosure, IB distal end  131  is the portion of inflatable balloon  115  that distally attaches or fixes inflatable balloon  115  to shaft  105 . IB distal end  131  is defined as the distal portion of inflatable balloon  115  that remains contacting shaft  105  after inflatable balloon  115  in inflated. 
         [0048]    IB lumen  133  fluidly communicates with inflatable balloon  115 , which allows inflatable balloon  115  to be inflated by fluid passing through IB lumen  133 . 
         [0049]    SCB catheter  100  further comprises guidewire lumen (GWL)  119 , which longitudinally extends at least from shaft proximal end  112  to beyond shaft distal end  110 . GW lumen  119  ends at GWL distal end  120 . 
         [0050]    In some embodiments, IB proximal end  130  and IB distal end  131  connect to GWL outer surface  121  or shaft  105  using any method known to those of ordinary skill in the art. 
         [0051]    SCB catheter  100  further comprises scoring wire (SCW)  135 . Scoring wire  135  comprises fixed SCW end  136 , SCW IB section  137 , and movable SCW end  138 . Fixed SCW end  136  connects within shaft distal section  108  distal of IB distal end  131 . In some embodiments, fixed SCW end  136  attaches to GWL outer surface  121 . In other embodiments, fixed SCW end  136  attaches to the outer side of shaft wall  109 . Fixed SCW end  136  attaches using any method known to those of ordinary skill in the art. 
         [0052]    This configuration provides for a focused force element (scoring wire  135 ) alongside inflatable balloon  115 . 
         [0053]    The distance between scoring wire  135  and IB outer surface  132  can be any value recognized as useful by those of ordinary skill in the art. Once past inflatable balloon  115 , scoring wire  135  dives below shaft wall  109 , extending proximally inside of shaft  105 . Movable SCW end  138  sits inside of shaft  105  within shaft proximal section  106 . In some embodiments, scoring wire  135  occupies at least part of SCW lumen  1139  (shown in  FIGS. 8 a  and 8 b   ). 
         [0054]      FIG. 1 a   - FIG. 5 b    depicts SCB catheter  100  as having two scoring wires. In some embodiments, SCB catheter  100  has 1-15, 3-10, or 2-5 scoring wires. In some embodiments the diameter of SCW  135  is between 0.003 inches and 0.040 inches, or 0.005 inches and 0.015 inches, 0.008 inches and 0.012 inches. In some embodiments, SCW  135  is 0.10 inches. SCW  135  need not have a uniform diameter. In some embodiments SCW distal section  1351  has a diameter larger than SCW proximal section  1352 . In some embodiments SCW distal section  1351  has a diameter smaller than SCW proximal section  1352 . In some embodiments, SCW  135  comprises metals, metal alloys, polymers, and shape memory materials that are metal- or polymer-based. 
         [0055]    SCB catheter  100  further comprises hub  140 . Hub  140  resides inside of shaft  105  within shaft proximal section  106 . Hub  140  comprises a GWL passage  141  for guidewire lumen  119  to pass through. Hub  140  further comprises one or more hub lumens  145  that interact with movable SCW end  138 . 
         [0056]    In some embodiments, the interaction encompasses movable SCW end  138  connected in or to hub lumen  145 . In some embodiments, movable SCW end  138  is fixed to hub lumen  145 . In other embodiments, the interaction encompasses movable SCW end  138  being slidably engaged inside of hub lumen  145 . In some embodiments hub  140  comprises any biocompatible material such as metals, metal alloys, and polymers. In some embodiments hub  140  comprises nylon, Pebax, or any other suitable material known to those of ordinary skill in the art. 
         [0057]    In some embodiments hub  140  is substantially fixed inside shaft proximal section  106  with movable SCW end  138  slidably engaged or disposed within hub lumen  145 . In some embodiments, hub  140  is longitudinally movable or elastic, allowing movable SCW end  138  to move longitudinally by pulling hub  140  distally, by moving hub  140  or by stretching material of hub  140 . For instance, in some embodiments, hub  140  is elastic. When movable SCW end  138  is subjected to a distally directed force that causes it to move distally and when movable SCW end  138  is fixed to or within hub lumen  145 , the movement stretches hub  140 . The restoring force or force counter to that distal stretching (counterforce) tends to move movable SCW end  138  substantially back into place when the distally directed force is removed. 
         [0058]    In some embodiments, hub  140  is biased by a spring  200 . In some embodiments, spring  200  mounts distal to hub  140  and in some embodiments, spring  200  mounts proximal to hub  140 . 
         [0059]    SCW catheter  100  further comprises handle assembly  150 . Handle assembly  150  associates with shaft proximal end  109 . Handle assembly  150  comprises HA port sub-assembly and HA transition sub-assembly. HA port sub-assembly occupies at least part of the proximal end of handle assembly  150 . And HA transition sub-assembly occupies at least part of the distal end of handle assembly  150 . HA port sub-assembly relates to HA transition sub-assembly. In some embodiments, HA port sub-assembly connects to or is fixed to HA transition sub-assembly. In some embodiments, HA port sub-assembly and HA transition sub-assembly together form a monolithic object or a number of objects or monolithic objects split by a plane containing SCW catheter  100 &#39;s longitudinal axis. 
         [0060]    HA transition sub-assembly comprises HA stepped-down portion  156  located at the distal end of HA transition sub-assembly. In some embodiments the distal end of HA transition sub-assembly and the distal end of handle assembly  150  are the same object. 
         [0061]    HA stepped-down portion  156  is a portion of HA transition sub-assembly in which the overall outside dimension has a step transition decreasing to a smaller diameter, sized to engage shaft proximal end  112 . 
         [0062]    In some embodiments, transition subassembly  152  does not have HA stepped-down portion  156 . 
         [0063]    Shaft  105  relates to handle assembly  150  through shaft proximal end  112  and HA stepped-down portion  156 . In some embodiments, shaft  105  connects to handle assembly  150 . For example, shaft proximal end  112  can slide over HA stepped-down portion  156  and the components can be fixed such as by welding, fusing, gluing, etc. Or the friction fit between shaft proximal end  112  and HA transition sub-assembly can be strong enough to fix the components together. In some embodiments lacking HA stepped-down portion  156 , shaft proximal end  112  can connect to handle assembly  150  through a butt joint between shaft proximal end  112  and HA transition subassembly  152 . 
         [0064]    HA port sub-assembly comprises HA GW port  154 , which occupies the proximal end of HA port sub-assembly. In some versions of handle assembly  150 , HA GW port  154  points away or directly away from shaft distal end  110 . HA GW port  154  allows access from outside of SCB catheter  100  into guidewire lumen  119 . In some versions of handle assembly  150 , HA port subassembly also comprises HA IB lumen port  153 , which angles out from the longitudinal axis of SCB catheter  100  at any of a variety of angles recognized as useful to those of ordinary skill in the art. In some versions, HA IB lumen port  153  flows into the guidewire-port-guidewire-lumen region and in other embodiments flows to a separate lumen inside or outside (not shown) of guidewire lumen  119 . HA IB lumen port  153  also allows access from outside of SCB catheter  100  into a passageway (guidewire lumen  119  or IB lumen  133  (IBL)) that carries gas or inflation fluid into inflatable balloon  115  to inflate it or carries gas or inflation fluid out of inflatable balloon  115  to deflate it. 
         [0065]    Operationally, in the devices taught by the  FIG. 1 a    embodiment, for treatment of calcified lesions, for example, a physician cuts through the patient&#39;s tissue until an appropriately sized vessel is revealed. The vessel must lead to the lesion site following a path that SCB catheter  100  can follow. In some embodiments, the location of the lesion site causes those of ordinary skill in the art to select a more or less flexible shaft  105  or SCB catheter  100 . 
         [0066]    The physician opens the vessel, inserts a guidewire into the vessel, and advances the guidewire through the patient&#39;s vasculature under ultrasound, magnetic resonance, fluoroscopic, or some other type of guidance. Once the physician places the guidewire at a satisfactory site, the physician threads the proximal end of the guidewire into GWL distal end  120 , through guidewire lumen  119 , and ultimately out of SCB catheter  100  through HA GW port  154 . With the guidewire in place and installed in SCB catheter  100 , the physician maneuvers SCB catheter  100  along the guidewire until inflatable balloon  115  reaches the desired position near the lesion site. Typically, this position will allow at least one scoring wire  135  to effectively engage the lesion. After that, the physician inflates inflatable balloon  115  until scoring wire  135  firmly presses into or cracks the lesion. Once lesion treatment with SCB catheter  100  is complete, the physician deflates inflatable balloon  115 , which allows scoring wire  135  to relax away from the lesion and from the vessel wall. 
         [0067]    Scoring wire  135  contacts the lesion as long as inflatable balloon  115  remains inflated. The inflation time corresponds to the time the physician chooses for scoring wire  135  to contact the lesion. Those of ordinary skill in the art use inflation times of 5 seconds to 5 minutes. Those of ordinary skill in the art look to the nature of the lesion in determining the appropriate inflation time and inflation speed. 
         [0068]    An aspect of this invention includes the behavior of scoring wire  135  during balloon inflation and specifically includes the behavior of movable SCW end  138 . 
         [0069]    As inflatable balloon  115  inflates, scoring wire (or wires)  135  expands outwardly, placing scoring wire  135  under longitudinal tension. A component of the force vector caused by that longitudinal tension points proximally from fixed SCW end  136  and distally from movable SCW end  138 . But fixed SCW end  136  is fixed to shaft  105  or GWL outer surface  121 . Therefore, any movement of scoring wire  135  occurs at movable SCW end  138 . Hub  140  constrains the movement of movable SCW end  138  allowing it to move longitudinally. This movement decreases the strain on inflatable balloon  115  helping to maintain its engineered shape and helping to avoid any kinking in the balloon&#39;s net, which was sometimes seen in prior art devices having scoring wires substantially fixed at both ends. 
         [0070]    When the physician deflates the balloon, the forces previously causing scoring wire  135  to expand disappear, allowing scoring wire  135  (and movable SCW end  138 ) to relax. Hub  140  constrains the relaxation of movable SCW end  138 . Specifically, hub  140  guides movable SCW end  138  into an arrangement similar to the initial arrangement of movable SCW end  138  before balloon inflation. Hub  140 &#39;s action helps regularize the inflation and deflation steps increasing their predictability. 
         [0071]    Returning to  FIG. 1 a   ,  FIG. 1 a    depicts the catheter as described above. The specific shaft  105  can be made by a variety of methods as known to those of ordinary skill in the art. The embodiment shown in  FIG. 1 a    comprises shaft  105  coupled (attached, connected, joined) to handle assembly  150  through HA distal end portion  155  and HA stepped-down portion  156 . HA stepped-down portion  156  occupies shaft lumen  113  and substantially seals shaft proximal end  112  from the atmosphere. In some embodiments, shaft proximal end  112  and HA distal end portion  155  are glued together with an adhesive. In other embodiments, an adhesive is not used. Those of ordinary skill in the art know of other joining methods. These are considered to be within the scope of the current invention. 
         [0072]    In  FIG. 1 a   , HA stepped-down portion  156  sits midway along HA distal end portion  155 &#39;s length. Moreover, in this embodiment HA distal end portion  155  also serves as hub  140 . The reference numbers refer to the same component because the component serves both as HA distal end  155  and as hub  140 . 
         [0073]      FIG. 1 b    is magnified view of shaft proximal section  106 . Shaft  105  ends at shaft proximal end  112  and receives hub  140 , which is either part of HA distal end  155  or not. Hub  140  can have one or more hub lumens  145 — FIG. 1 b    shows two hub lumens  145 . These hub lumens  145  extend into hub  140  longitudinally in this embodiment. But SCB catheter  100  does not need lengthwise hub lumens  145  to function correctly. Hub lumens  145  need only function to slidably and reversibly receive movable SCW end  138 .  FIG. 1 b    shows hub lumens  145  extending into hub  140  approximately three quarters of hub  140 &#39;s length, but this is not critical. In some embodiments, hub lumens  145  extend completely through hub  140 . Hub lumens  145  extend into hub  140  as far as or further than movable SCW end  138  extends into hub lumen  145 .  FIG. 1 b    also shows scoring wire  135  and movable SCW end  138 . In this embodiment, scoring wire  135  tapers or flares outwardly after proximally exiting SCW lumen  1139 . Movable SCW end  138  occupies a portion of hub lumen  145 . In this embodiment, SCB catheter  100  comprises one hub lumen  145  per movable SCW end  138 . But other embodiments exist in which a hub lumen can interact with more than one movable SCW end  138 . 
         [0074]    Finally,  FIG. 1 b    shows guidewire lumen  119  passing through hub  140  and continuing into shaft  105 .  FIG. 1 c    depicts a magnified view of the region where scoring wire  135  distally exits SCW lumen  1139 . 
         [0075]    Scoring wire  135  has a path through part of SCB catheter  100 . SCW lumen  1139  is a lumen that receives scoring wire  135  along some or all of shaft middle section  107 . We refer to the portion of scoring wire  135  within SCW lumen  1139  as SCW lumen section  1361 . And we refer to the section of scoring wire  135  near inflatable balloon  115  as SCW IB section  137 . 
         [0076]    For discussion purposes, we begin the path at movable SCW end  138 . Movable SCW end  138  resides within hub lumen  145 . As we move distally along scoring wire  135 , we come to the proximal end of SCW lumen  1139 , which scoring wire  135  occupies. In some embodiments, scoring wire  135  tapers inwardly proximally of SCW lumen  1139 . Scoring wire  135  distally exits SCW lumen  1139  at the lumen&#39;s distal end. We refer to the section of scoring wire  135  that begins at this exit as SCW IB section  137 . After exiting, scoring wire  135  flares outward as it progresses distally, extending in a substantially longitudinal direction until the wire is past IB distal end  131 . At that point scoring wire  135  turns inwardly until it reaches shaft distal section  108  or GWL outer surface  121 . Fixed SCW end  136  attaches to SCB catheter  100  distally of inflatable balloon  115  or at or near the point where IB distal end  131  attaches to SCB catheter  100 . The portion of scoring wire  135  within SCW IB section  137  has a longitudinal region along inflatable balloon  115 . The distance this longitudinal section extends from SCB catheter  100 &#39;s central axis (wire distance) can have a variety of values. The distance that IB outer surface  132  extends from the central axis when inflatable balloon  115  inflates is the balloon inflation distance. Typically, (wired distance)/(balloon inflation distance) is within the following ranges 0.99-1.01; 0.90-1.1; 0.8-1.2; and 0.5-1.5. 
         [0077]    In the operation of the group of embodiments represented by the device in  FIG. 1 a   , a physician places inflatable balloon  115  as described above. The physician inflates inflatable balloon  115  through HA IB lumen port  153 . Balloon inflation first applies outward pressure on scoring wires  135  and then onto the lesion. Without wishing to be bound by any particular theory of operation, we believe that because movable SCW end  138  is moveably connected, scoring wire  135  does not contribute to balloon or balloon deformation caused by inflation or overinflation. Since the wire can move outwardly, it does not significantly cage the balloon. The caging effect will prevent the balloon from expanding past the wires. But if inflation continues, some other portion of the balloon will deform from the pressure exerted by the inflation fluid. In some cases balloon deformation leads to problems with later deflating the balloon. Instead, the outwardly directed inflation pressure on scoring wire  135  causes movable SCW end  138  to move distally, which lowers the counterforce that scoring wire  135  exerts against inflatable balloon  115 . As movable SCW end  138  moves distally, it recedes from hub lumen  145 . In some embodiments, inflation pressure causes movable SCW end  138  to pull out of hub lumen  145 . In other embodiments, movable SCW end  138  remains inside of hub lumen  145 . 
         [0078]    The physician maintains pressure in inflatable balloon  115  long enough for scoring wire  135  to have the effect the physician desires. Afterward, the physician releases pressure, inflatable balloon  115  deflates, and movable SCW end  138  re-extends into hub lumen  145 . 
         [0079]      FIGS. 2 a  through 2 c    depict different embodiments of SCB catheter  100 . These embodiments are similar to those shown in  FIGS. 1 a  through 1 c   . The main difference between the sets of embodiments lies in the hub and the proximal scoring wire geometry. 
         [0080]      FIG. 2 b    depicts a hub  140  that has hub distal section  241  and hub proximal section  242 . Hub proximal section  242  through HA stepped-down portion  156  serves to connect shaft  105  with handle assembly  150 . Additionally, hub proximal section  242  serves as a stop for spring  200 . Spring  200  comprises spring wire  201 —the figure depicts spring wire  201  in cross-section. Spring  200  adds resilience to the mechanism of scoring wire  135 . 
         [0081]    Hub distal section  241  lies next to the distal end of spring  200 . Hub distal section  241  connects (attaches) to movable SCW end  138 . In some embodiments, hub distal section  241  is fixed to movable SCW end  138 . In other embodiments, hub distal section  241  comprises hub lumens  145 , which in some cases are fixed to movable SCW end  138 . Movable SCW end  138  flares outwardly as it reaches hub distal section  241 . In this embodiment, on the other hand, the embodiment shown in  FIG. 3 a  through 3 c    comprise movable SCW ends  138  that do not flare as it reaches hub distal section  241 . 
         [0082]    In the operation of the group of embodiments represented by the devices disclosed in  FIGS. 1 a   - 6 , a physician places inflatable balloon  115  as described above. The physician inflates inflatable balloon  115  through HA IB lumen port  153 , which first applies outer pressure on scoring wires  135  and then on the lesion. The difference in operation between the above embodiments and the group of embodiments represented by  FIGS. 1 a 3 c    is in the mechanism that that allows movement by movable SCW end  138 . As in the above embodiments, in these embodiments, as inflatable balloon  115  inflates, the counterforce that scoring wire  135  would otherwise apply, is moderated by movable SCW end  138 . In this group, movable SCW end  138  recedes distally as before, but hub distal section  241  also moves distally. The arrangement of hub distal section  241 , spring  200 , and hub proximal section  242  imparts force, through hub distal section  241 , to movable SCW end  138 . This force tends to proximally bias movable SCW end  138 . And when the physician deflates the balloon as before, movable SCW end  138  moves proximally, substantially back to its initial position, aided by the force of spring  200 . 
         [0083]      FIGS. 4 a -4 b    depict another embodiment of SCB catheter  100 . The device of this embodiment is substantially similar to the embodiments described above. The main difference is that this version of hub distal section  241 , although similar to hub distal sections described above, has narrowed region  340  that extends proximally from hub distal section  241 . Narrowed region  340  sits inside of spring  200 . 
         [0084]    Similarly,  FIG. 5 a    has narrowed region  340  and additionally has extension  451  sitting between hub distal section  241  and narrowed region  340 . Finger grip  400  sits on extension  451 , extending through the side of shaft proximal section  106 . Finger grip  400  provides the physician some control of distal hub  450 , which enables more direct control of movable SCW end  138  in these types of embodiments. 
         [0085]      FIG. 6  discloses an embodiment of the proximal section of the device. In this embodiment a spring  200  sits within the distal end of HA  150  and extends distally from HA  150 . Hub  140  connects to HA  150  and forms a monolithic structure with HA  150 . Spring  200  receives shaft proximal section  106 . Movable SCW end  138  exits scoring wire lumen  1139  near the distal end of shaft proximal section  106 . Movable SCW end  138  connects directly to spring  200  through any suitable method, such as soldering, welding, overmolding, gluing, or press fitting using plastic tubing. In some embodiments, movable SCW end  138  connects directly to spring  200  through a weld joint  1362 . In this or other embodiments, hub cover  700  sits over hub  140  and shaft  105 . In some cases, hub cover  700  provides strain relieve for the connection between HA  150  and shaft  105 . 
         [0086]    The spring  200  provides longitudinal movement and a biasing force to movable SCW end  138 . When movable SCW end  138  experiences a distally directed force that moves it distally, the movement holds that away from HA  150 . The restoring force or force counter to that distal stretching (counterforce) tends to move movable SCW end  138  substantially back into place once the distally directed force disappears. 
         [0087]      FIG. 7 a    depicts section AA of  FIG. 1 a   . It shows two scoring wires  135 , inflatable balloon  115 , IB lumen  133 , and guidewire lumen  119 . As can be seen, section plane AA cuts through SCB catheter  100  at shaft distal section  108 . The plane also cuts inflatable balloon  115 ; cuts scoring wire  135  at SCW IB section  137  showing SCW cross-section  505 ; and cuts guidewire lumen  119 .  FIG. 7 b    depicts a similar embodiment, but with three scoring wires  135 . 
         [0088]      FIG. 8 a    depicts section BB of  FIG. 1 a   . It shows two SCW lumens  1139  sitting side-by-side. It also shows IB lumen  133  and GW lumen  119 . SCW lumen  1139  need not adopt a side-by-side configuration, as shown in this figure, but can adopt a configuration distributed around the perimeter of shaft  105 . 
         [0089]      FIG. 8 b    shows a different embodiment similar to  FIG. 1 a    in cross-section. Shaft proximal section  106  is cut proximally of shaft tapered section  111 . Shaft tapered section  111  tapers from shaft proximal section  106  to shaft middle section  107 . Shaft  105  has shaft wall  109 . For example,  FIG. 8 b    depicts two SCW lumens  1139  distributed across from each other in shaft  105 . This distribution need not be symmetric. Also in this figure, guidewire lumen  119  lies within shaft  105 , and it shows SCW lumen  1139  extending longitudinally inside of shaft  105 . In some embodiments, SCW lumens sit outside of the guidewire lumen. 
         [0090]      FIG. 9  shows the embodiment of  FIG. 6  in cross-section. In this figure, guidewire lumen  119  lies within shaft  105 . In some embodiments, shaft  105  is an extrusion providing guidewire lumen  119 , two SCW lumen  1139 , and one lumen  133 . 
         [0091]    In any of the embodiments set out above, inflatable balloon  115  can have any of a variety of diameters ranging from 1.25-40 mm or 2.0-8.0 mm. In any of the embodiments set out above, inflatable balloon  115  can have any of a variety of lengths such as 10-300 mm or 20-300 mm. Long balloons may be particularly useful for treating peripheral lesions, which often have long diseased portions. 
         [0092]    In all of the systems described above, a coating such as a hydrophobic or hydrophilic coating may be added externally to provide ease of insertion. 
         [0093]    Suitable drugs or therapeutic agents include the following substances. 
         [0094]    Antimicrobial agents may be selected, for example, from triclosan from triclosan, chlorhexidine, nitrofurazone, benzalkonium chlorides, silver salts and antibiotics such as rifampin, gentamycin and minocyclin and combinations thereof, among others. 
         [0095]    In certain embodiments, antimicrobial agents may include triclosan, chlorhexidine and salts or combinations thereof. Anti-inflammatory agents include steroidal and non-steroidal anti-inflammatory agents. Examples of nonsteroidal anti-inflammatory drugs include aminoarylcarboxylic acid derivatives such as enfenamic acid, etofenamate, flufenamic acid, isonixin, meclofenamic acid, mefanamic acid, niflumic acid, talniflumate, terofenamate and tolfenamic acid; arylacetic acid derivatives such as acemetacin, alclofenac, amfenac, bufexamac, cinmetacin, clopirac, diclofenac sodium, etodolac, felbinac, fenclofenac, fenclorac, fenclozic acid, fentiazac, glucametacin, ibufenac, indomethacin, isofezolac, isoxepac, lonazolac, metiazinic acid, oxametacine, proglumetacin, sulindac, tiaramide, tolmetin and zomepirac; arylbutyric acid derivatives such as bumadizon, butibufen, fenbufen and xenbucin; arylcarboxylic acids such as clidanac, ketorolac and tinoridine; arylpropionic acid derivatives such as alminoprofen, benoxaprofen, bucloxic acid, carprofen, fenoprofen, flunoxaprofen, flurbiprofen, ibuprofen, ibuproxam, indoprofen, ketoprofen, loxoprofen, miroprofen, naproxen, oxaprozin, piketoprofen, pirprofen, pranoprofen, protizinic acid, suprofen and tiaprofenic acid; pyrazoles such as difenamizole and epirizole; pyrazolones such as apazone, benzpiperylon, feprazone, mofebutazone, morazone, oxyphenbutazone, phenybutazone, pipebuzone, propyphenazone, ramifenazone, suxibuzone and thiazolinobutazone; salicylic acid and its derivatives such as acetaminosalol, aspirin, benorylate, bromosaligenin, calcium acetylsalicylate, diflunisal, etersalate, fendosal, gentisic acid, glycol salicylate, imidazole salicylate, lysine acetylsalicylate, mesalamine, morpholine salicylate, 1-naphthyl salicylate, olsalazine, parsalmide, phenyl acetylsalicylate, phenyl salicylate, salacetamide, salicylamine a-acetic acid, salicylsulfuric acid, salsalate and sulfasalazine; thiazinecarboxamides such as droxicam, isoxicam, piroxicam and tenoxicam; others such as Eacetamidocaproic acid, s-adenosylmethionine, 3-amino-4-hydroxybutyric acid, amixetrine, bendazac, benzydamine, bucolome, difenpiramide, ditazol, emorfazone, guaiazulene, nabumetone, nimesulide, orgotein, oxaceprol, paranyline, perisoxal, pifoxime, proquazone, proxazole and tenidap; and pharmaceutically acceptable salts thereof. 
         [0096]    Examples of steroidal anti-inflammatory agents (glucocorticoids) include 21-acetoxyprefnenolone, alclometasone, algestone, amicinonide, beclomethasone, betamethasone, budesonide, chloroprednisone, clobetasol, clobetasone, clocortolone, cloprednol, corticosterone, cortisone, cortivazol, deflazacort, desonide, desoximetasone, dexamethasone, diflorasone, diflucortolone, difluprednate, enoxolone, fluazacort, flucloronide, flumehtasone, flunisolide, fluocinolone acetonide, fluocinonide, fluocortin butyl, fluocortolone, fluorometholone, fluperolone acetate, fluprednidene acetate, fluprednisolone, flurandrenolide, fluticasone propionate, formocortal, halcinonide, halobetasol priopionate, halometasone, halopredone acetate, hydrocortamate, hydrocortisone, loteprednol etabonate, mazipredone, medrysone, meprednisone, methyolprednisolone, mometasone furoate, paramethasone, prednicarbate, prednisolone, prednisolone 25-diethylaminoacetate, prednisone sodium phosphate, prednisone, prednival, prednylidene, rimexolone, tixocortal, triamcinolone, triamcinolone acetonide, triamcinolone benetonide, triamcinolone hexacetonide, and pharmaceutically acceptable salts thereof. 
         [0097]    Analgesic agents include narcotic and non-narcotic analgesics. Narcotic analgesic agents include alfentanil, allylprodine, alphaprodine, anileridine, benzylmorphine, bezitramide, buprenorphine, butorphanol, clonitazene, codeine, codeine methyl bromide, codeine phosphate, codeine sulfate, desomorphine, dextromoramide, dezocine, diampromide, dihydrocodeine, dihydrocodeinone enol acetate, dihydromorphine, dimenoxadol, dimepheptanol, dimethylthiambutene, dioxaphetyl butyrate, dipipanone, eptazocine, ethoheptazine, ethylmethlythiambutene, ethylmorphine, etonitazene, fentanyl, hydrocodone, hydromorphone, hydroxypethidine, isomethadone, ketobemidone, levorphanol, lofentanil, meperidine, meptazinol, metazocine, methadone hydrochloride, metopon, morphine, myrophine, nalbuphine, narceine, nicomorphine, norlevorphanol, normethadone, normorphine, norpipanone, opium, oxycodone, oxymorphone, papaveretum, pentazocine, phenadoxone, phenazocine, pheoperidine, piminodine, piritramide, proheptazine, promedol, properidine, propiram, propoxyphene, rumifentanil, sufentanil, tilidine, and pharmaceutically acceptable salts thereof. Non-narcotic analgesics include aceclofenac, acetaminophen, acetaminosalol, acetanilide, acetylsalicylsalicylic acid, alclofenac, alminoprofen, aloxiprin, aluminum bis(acetylsalicylate), aminochlorthenoxazin, 2-amino-4-picoline, aminopropylon, aminopyrine, ammonium salicylate, amtolmetin guacil, antipyrine, antipyrine salicylate, antrafenine, apazone, aspirin, benorylate, benoxaprofen, benzpiperylon, benzydamine, bermoprofen, brofenac, p-bromoacetanilide, 5-bromosalicylic acid acetate, bucetin, bufexamac, bumadizon, butacetin, calcium acetylsalicylate, carbamazepine, carbiphene, carsalam, chloralantipyrine, chlorthenoxazin(e), choline salicylate, cinchophen, ciramadol, clometacin, cropropamide, crotethamide, dexoxadrol, difenamizole, diflunisal, dihydroxyaluminum acetylsalicylate, dipyrocetyl, dipyrone, emorfazone, enfenamic acid, epirizole, etersalate, ethenzamide, ethoxazene, etodolac, felbinac, fenoprofen, floctafenine, flufenamic acid, fluoresone, flupirtine, fluproquazone, flurbiprofen, fosfosal, gentisic acid, glafenine, ibufenac, imidazole salicylate, indomethacin, indoprofen, isofezolac, isoladol, isonixin, ketoprofen, ketorolac, plactophenetide, lefetamine, loxoprofen, lysine acetylsalicylate, magnesium acetylsalicylate, methotrimeprazine, metofoline, miroprofen, morazone, morpholine salicylate, naproxen, nefopam, nifenazone, 5′ nitro-2′ propoxyacetanilide, parsalmide, perisoxal, phenacetin, phenazopyridine hydrochloride, phenocoll, phenopyrazone, phenyl acetylsalicylate, phenyl salicylate, phenyramidol, pipebuzone, piperylone, prodilidine, propacetamol, propyphenazone, proxazole, quinine salicylate, ramifenazone, rimazolium metilsulfate, salacetamide, salicin, salicylamide, salicylamide a-acetic acid, salicylsulfuric acid, salsalte, salverine, simetride, sodium salicylate, sulfamipyrine, suprofen, talniflumate, tenoxicam, terofenamate, tetradrine, tinoridine, tolfenamic acid, tolpronine, tramadol, viminol, xenbucin, zomepirac, and pharmaceutically acceptable salts thereof. 
         [0098]    Local anesthetic agents include amucaine, amolanone, amylocaine hydrochloride, benoxinate, benzocaine, betoxycaine, biphenamine, bupivacaine, butacaine, butaben, butanilicaine, butethamine, butoxycaine, carticaine, chloroprocaine hydrochloride, cocaethylene, cocaine, cyclomethycaine, dibucaine hydrochloride, dimethisoquin, dimethocaine, diperadon hydrochloride, dyclonine, ecgonidine, ecgonine, ethyl chloride, betaeucaine, euprocin, fenalcomine, fomocaine, hexylcaine hydrochloride, hydroxytetracaine, isobutyl p-aminobenzoate, leucinocaine mesylate, levoxadrol, lidocaine, mepivacaine, meprylcaine, metabutoxycaine, methyl chloride, myrtecaine, naepaine, octacaine, orthocaine, oxethazaine, parethoxycaine, phenacaine hydrochloride, phenol, piperocaine, piridocaine, polidocanol, pramoxine, prilocaine, procaine, propanocaine, proparacaine, propipocaine, propoxycaine hydrochloride, pseudococaine, pyrrocaine, ropavacaine, salicyl alcohol, tetracaine hydrochloride, tolycaine, trimecaine, zolamine, and pharmaceutically acceptable salts thereof. 
         [0099]    Antispasmodic agents include alibendol, ambucetamide, aminopromazine, apoatropine, bevonium methyl sulfate, bietamiverine, butaverine, butropium bromide, n-butylscopolammonium bromide, caroverine, cimetropium bromide, cinnamedrine, clebopride, coniine hydrobromide, coniine hydrochloride, cyclonium iodide, difemerine, diisopromine, dioxaphetyl butyrate, diponium bromide, drofenine, emepronium bromide, ethaverine, feclemine, fenalamide, fenoverine, fenpiprane, fenpiverinium bromide, fentonium bromide, flavoxate, flopropione, gluconic acid, guaiactamine, hydramitrazine, hymecromone, leiopyrrole, mebeverine, moxaverine, nafiverine, octamylamine, octaverine, oxybutynin chloride, pentapiperide, phenamacide hydrochloride, phloroglucinol, pinaverium bromide, piperilate, pipoxolan hydrochloride, pramiverin, prifinium bromide, properidine, propivane, propyromazine, prozapine, racefemine, rociverine, spasmolytol, stilonium iodide, sultroponium, tiemonium iodide, tiquizium bromide, tiropramide, trepibutone, tricromyl, trifolium, trimebutine, n,n-1 trimethyl-3,3-diphenyl-propylamine, tropenzile, trospium chloride, xenytropium bromide, and pharmaceutically acceptable salts thereof. 
         [0100]    In certain embodiments, therapeutic agents for reducing pain or discomfort may be selected from ketorolac and pharmaceutically acceptable salts thereof (e.g., the tromethamine salt thereof, sold under the commercial name Torado®), 4-diethylamino-2-butynylphenylcyclohexylglycolate and pharmaceutically acceptable salts thereof (e.g., 4-diethylamino-2-butynylphenylcyclohexylglycolate hydrochloride, also known as oxybutynin chloride, sold under the commercial name Ditropang®), and combinations thereof. The amount of therapeutic agent present, will depend, for example, upon the efficacy of the therapeutic agent employed, the release rate, and so forth. One skilled in the art can readily determine an appropriate therapeutic agent loading to achieve the desired outcome. 
         [0101]    In some embodiments, the surface of IB  115  is embossed with any of a variety of patterns. For example, in some embodiments the surface of IB  115  is embossed with a checkered pattern. Additionally, in some embodiments, inflatable balloon  115  tapers along its longitudinal direction. 
         [0102]    In some embodiments, scoring wire  135  sits within SCW lumen  1139 . And in some embodiments, SCW lumen  1139  sits outside of shaft  105 . 
         [0103]    Although the invention has been described in conjunction with specific embodiments, many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, it embraces all such alternatives, modifications, and variations that fall within the appended claims&#39; spirit and scope. All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention.