Patent Publication Number: US-10772657-B2

Title: Atherectomy with subintimal space

Description:
TECHNICAL FIELD 
     The present disclosure generally relates to a medical device or dissecting device for cutting a substance from an inner wall surface of a body lumen, and more particularly, for treating a stenotic vessel with a dissecting device, which is inserted into a subintimal space from a blood vessel, and which cuts a stenotic region with the cutting member while advancing a directional guide member into the subintimal space. 
     BACKGROUND DISCUSSION 
     For physicians, it can be difficult to treat chronic total occlusion (CTO) and highly narrowing blood vessel regions due to difficulties associated with passing a guide wire before percutaneous transluminal angioplasty (PTA) and stent treatment. In these situations, physicians can perform a guide wire approach called the knuckle technique, for example, using, for example, a 0.035-inch wire with re-entry, for example, using a Rendez-vous technique. In these approaches, the guide wire is passed through and placed into the subintimal space. 
     A narrowed vessel can also be debulked by atherectomy to avoid the complications from PTA and stent treatment. However, physicians cannot always debulk the volume due to perforation risk during atherectomy treatment. In addition, other approaches include a true lumen wire approach, which can be time consuming since passing the wire through the true lumen can be difficult, and a subintimal wiring approach, which does not perform debulking by atherectomy. 
     Physicians can also perform a surgical treatment called endarterectomy to treated stenosis. In the femoral artery, for example, remote endarterectomy procedures are known. However, these procedures require large incisions to insert the medical devices and remove the intimal layer, which has been peeled off from the occluded vessel. 
     In view of the risks and difficulties with the known techniques, a less invasive technique is desirable, which can cut or debulk a stenotic region in only the true lumen side. In addition, it would be desirable, if the method and dissecting device can save time by avoiding trying to pass a wire through the true lumen, lower the risk of dissection and perforation during PTA and stenting from the subintimal space, and provide for re-entry during atherectomy. 
     SUMMARY 
     A method is disclosed for treating a stenotic vessel, the method comprising: inserting a dissecting device into a subintimal space of a blood vessel; dissecting an inner side of the subintimal space from an outer side of the subintimal space over an entire circumference of the blood vessel with the dissecting device, the dissecting device including a first dissecting member having a first cutting member; and removing the dissected inner side of the subintimal space and a stenotic region attached to the inner side of the subintimal space from the blood vessel. 
     A dissecting device is disclosed for treating a stenotic vessel, the dissecting device comprising: a first dissecting member for dissecting an inner side of a subintimal space from an outer side of the subintimal space over an entire circumference of the blood vessel, the first dissecting member having a cutting member on a distal end of the first dissecting member, which is configured to be rotated around the entire circumference of the blood vessel to separate the inner side of the subintimal space and the stenotic region from the outer side of the subintimal space. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a schematic view illustrating a medical device (or a dissecting device), which includes a directional guide member and a cutting member, which advance together in accordance with a first exemplary embodiment. 
         FIG. 2A  is a perspective view of the dissecting device in accordance with the first exemplary embodiment. 
         FIG. 2B  is an end view of the dissecting device as shown in  FIG. 2A  in accordance with an exemplary embodiment. 
         FIG. 2C  is a top view of the dissecting device as shown in  FIGS. 2A and 2B  in accordance with an exemplary embodiment. 
         FIG. 3  is a plan view illustrating a guide wire in a stenosed site with a subintimal space wiring with re-entry in accordance with an exemplary embodiment. 
         FIG. 4  is a plan view illustrating the dissecting device in the stenosed site performing the atherectomy of the stenosis in accordance with an exemplary embodiment. 
         FIGS. 5A-5C  is a perspective view, an end view, and a top view, respectively, of a dissecting device having a directional guide member with horizontal stabilization in accordance with an alternative exemplary embodiment. 
         FIGS. 6A-6C  is a perspective view, an end view, and a top view, respectively, of a dissecting device in accordance with another alternative exemplary embodiment. 
         FIGS. 7A-7C  is a perspective view, an end view, and a top view, respectively, of a dissecting device in accordance with a further exemplary embodiment. 
         FIGS. 8A-8C  is a perspective view, an end view, and a top view, respectively, of a dissecting device as shown in  FIGS. 7A-7C  with a front force pushing into the subintimal space in accordance with an exemplary embodiment. 
         FIGS. 9A and 9B  is a perspective view and an end view, respectively, of a dissecting device in accordance with a further embodiment of the first exemplary embodiment. 
         FIG. 10  is a plan view of the dissecting device of  FIGS. 9A and 9B  in accordance with an exemplary embodiment. 
         FIG. 11  is a plan view of the directional guide member having a tip as shown in  FIG. 10  in an inactive state in accordance with an exemplary embodiment. 
         FIG. 12  is a plan view of the directional guide member as shown in  FIG. 10  in an active state in accordance with an exemplary embodiment. 
         FIGS. 13A-13C  are plan views of the dissecting device having a tip on the distal end of the directional guide wire as shown in  FIGS. 9A-12 . 
         FIG. 14A  is a perspective view of a dissecting device having a bellow structure in accordance with an alternative embodiment of the first exemplary embodiment. 
         FIG. 14B  is an end view of the dissecting device having a bellow structure as shown in  FIG. 14A  in accordance with an exemplary embodiment. 
         FIGS. 15A and 15B  are perspective views of the dissecting device with a bellow structure as shown in  FIGS. 14A and 14B  under threshold and over threshold, respectively. 
         FIG. 15C  is a perspective view of the dissecting device with a bellow structure as shown in  FIGS. 14A and 14B  with a coil type or coiled drive shaft in accordance with an exemplary embodiment. 
         FIGS. 16A-16C  are a perspective view, an end view, and a top view, respectively, of the dissecting device, which includes the directional guide member, the cutting member, and an imaging guide for atherectomy in accordance with an exemplary embodiment. 
         FIG. 16D  is a view on an imaging device, for example, an OCT/IVUS showing the dissecting device in use with the imaging portion or image sensor as shown in  FIGS. 16A-16C . 
         FIGS. 16E-16G  are plan views of subintimal wire spacing with the dissecting device and adjusting a direction of the cutting member with the imaging portion or image sensor in accordance with an exemplary embodiment. 
         FIGS. 16H and 16I  are plan views and views on an imaging device of the dissecting device of  FIGS. 16A-16C  in accordance with an example ( FIG. 16H ) in which a direction of the cutting member is good to go, and an example ( FIG. 16I , in which the direction of the cutting member is not good to go. 
         FIG. 17  is a perspective view illustrating a dissecting device having a directional guide member in the subintimal space and a cutting member and tubular member which slide on the directional guide member in accordance with a second exemplary embodiment. 
         FIG. 18  is a perspective view of the dissecting device as shown in  FIG. 17  in accordance with an exemplary embodiment. 
         FIG. 19  is an end view of the dissecting device as shown in  FIG. 18  in accordance with an exemplary embodiment. 
         FIG. 20  is a top view of the dissecting device as shown in  FIGS. 18 and 19  in accordance with an exemplary embodiment. 
         FIGS. 21A-21C  are a series of views illustrating the dissecting device as shown in  FIGS. 18-20  in use in accordance with an exemplary embodiment. 
         FIG. 22A  is a perspective view illustrating the directional guide member of a dissecting device having a cutting member with a bellow structure in accordance with an exemplary embodiment. 
         FIG. 22B  is a perspective view illustrating the cutting member with a bellow structure of a dissecting device, which slides along the directional guide member in accordance with an exemplary embodiment. 
         FIG. 22C  shows perspective views of the cutting device with a bellow structure of the dissecting device as shown in  FIG. 22B , which slides along the directional guide member. 
         FIG. 22D  is a top view of the guide member of the dissecting device as shown in  FIGS. 22A-22C  in accordance with an exemplary embodiment. 
         FIG. 23A  is a cross-sectional view of the guide member along the line XXIIIA-XXIIIA as shown in  FIGS. 22A and 22D  in accordance with two exemplary embodiments of the dissecting device in accordance with the first exemplary embodiment. 
         FIG. 23B  is a cross-sectional view of the guide member along the line XXIIIB-XXIIIB as shown in  FIGS. 22A and 22D  in accordance with the first exemplary embodiment. 
         FIG. 23C  is a cross-section view along the line XXIIIC-XXIIIC as shown in  FIG. 22B  of the tubular member in accordance with an exemplary embodiment. 
         FIG. 24A  is a perspective view illustrating the dissecting device with re-entry by a cutting member in accordance with another exemplary embodiment. 
         FIG. 24B  is a perspective view illustrating the dissecting device with re-entry by cutting member in accordance with an exemplary embodiment. 
         FIG. 24C  shows perspective views of the dissecting device with a bellow structure as the cutting member and tubular member slide along the guide member. 
         FIG. 24D  is a top view of the guide member of the dissecting device as shown in  FIG. 24A  in accordance with the second exemplary embodiment. 
         FIG. 25A  is a cross-sectional view of the guide member along the line XXVA-XXVA as shown in  FIGS. 24A and 24D  in accordance with two exemplary embodiments of the dissecting device in accordance with the first exemplary embodiment. 
         FIG. 25B  is a cross-sectional view of the guide member along the line XXVB-XXVB as shown in  FIGS. 24A and 24D  in accordance with the first exemplary embodiment. 
         FIG. 25C  is a cross-section view along the line XXVC-XXVC as shown in  FIG. 24B  of the tubular member in accordance with an exemplary embodiment. 
         FIG. 26  is a plan view of a dissecting system in accordance with an exemplary embodiment in which a dissecting member is shown in a bent state in accordance with a third exemplary embodiment. 
         FIG. 27  is a cross-sectional view of a blood vessel as shown in  FIG. 26  in which the dissecting member is in a bent state in accordance with the third exemplary embodiment. 
         FIGS. 28A and 28B  are plan views of the dissecting member as a balloon wire within a blood vessel in accordance with an exemplary embodiment. 
         FIG. 29  is a plan view of a cutting device in accordance with an exemplary embodiment. 
         FIG. 30  is a top view of the cutting device of  FIG. 29  in accordance with an exemplary embodiment. 
         FIGS. 31A-31C  are a series of cross-sectional views of the cutting device of  FIG. 30  along the lines XXXIA-XXXIA, XXXIB-XXXIB, and XXXIC-XXXIC, respectively, in accordance with an exemplary embodiment. 
         FIG. 32  is a plan view of the dissecting member as a balloon wire as shown in  FIG. 29  with a cutting device as shown in  FIGS. 30-31C  in accordance with an exemplary embodiment. 
         FIG. 33  is a cross-section view of a cutting device having a side port ( FIG. 34 ) for a dissecting member (or second dissecting member) and a cutting blade in accordance with another exemplary embodiment. 
         FIG. 34  is a top view of the cutting device of  FIG. 33  in accordance with an exemplary embodiment. 
         FIGS. 35A-35D  are a series of cross-sectional views of the cutting device of  FIG. 34  along the lines XXXVA-XXXVA, XXXVB-XXXVB, XXXVC-XXXVC, and XXXVD-XXXVD, respectively, in accordance with an exemplary embodiment. 
         FIG. 36  is a plan view of the dissecting member with a cutting device as shown in  FIGS. 33-35D  in accordance with an exemplary embodiment. 
         FIG. 37  is a perspective view of a dissecting device having a dissecting member in the form of a dissecting member or loop and a cutting member in accordance with an exemplary embodiment. 
         FIG. 38  is an end view of the dissecting device as shown in  FIG. 37  in accordance with an exemplary embodiment. 
         FIG. 39  is a top view of the dissecting device as shown in  FIGS. 37 and 38  in accordance with an exemplary embodiment. 
         FIG. 40  is a series of cross-sectional view illustrating the use of the dissecting device as shown in  FIGS. 37-39  in a blood vessel having a stenosed region. 
         FIG. 41  is a cross-sectional view illustrating the use of the dissecting device in a blood vessel having a stenosed region in accordance with a fourth embodiment. 
         FIG. 42  is a perspective view of a cutting device of the dissection device shown in  FIG. 41  in accordance with an exemplary embodiment. 
         FIG. 43  is a top view of the cutting device of  FIG. 42  in accordance with an exemplary embodiment. 
         FIGS. 44A-44D  are a series of cross-sectional views of the cutting device of  FIG. 43  and cross-sectional view along the lines XLIVA-XLIVA, XLIVB-XLIVB, XLIVC-XLIVC, and XLIVD-XLIVD, respectively, in accordance with an exemplary embodiment. 
         FIG. 45  is a plan view of the dissecting member as shown in  FIGS. 42-44D  in accordance with an exemplary embodiment. 
         FIG. 46  illustrates a series of end views of an exemplary method of removing a stenosed site from a blood vessel in accordance with an exemplary embodiment. 
         FIG. 47  illustrates a plan view of an exemplary method of removing a stenosed site from a blood vessel in accordance with an exemplary embodiment. 
         FIG. 48  illustrates a series of end views of another exemplary method of removing a stenosed site from a blood vessel in accordance with an exemplary embodiment. 
         FIG. 49  illustrates a plan view of an exemplary method of removing a stenosed site from a blood vessel in accordance with an exemplary embodiment. 
         FIG. 50  is a perspective view of a dissecting device in accordance with an alternative exemplary embodiment. 
         FIG. 51  is an end view of the dissecting device as shown in  FIG. 50  in accordance with an exemplary embodiment. 
         FIG. 52  is series of end views showing the dissecting device as shown in  FIGS. 50 and 51  in a blood vessel having a stenosed region. 
         FIG. 53  is a perspective view of the dissecting device in accordance with an exemplary embodiment. 
         FIG. 54  is an end view of the dissecting device as shown in  FIG. 53  in accordance with an exemplary embodiment. 
         FIG. 55  is series of end views showing the dissecting device as shown in  FIGS. 53 and 54  in a blood vessel having a stenosed region. 
         FIG. 56  is a plan view of the dissecting member as shown in  FIGS. 53 and 54  in accordance with an exemplary embodiment. 
     
    
    
     DETAILED DESCRIPTION 
     Hereinafter, embodiments of the present disclosure will be described with reference to the drawings. In order to facilitate description, dimensional ratios in the drawings are exaggerated, and thus are different from actual ratios in some cases. 
       FIG. 1  is a schematic view Illustrating a medical device (or dissecting device)  100 , which includes a directional guide member  130  and a tubular cutting member  110 , which advance together in accordance with a first exemplary embodiment. As shown in  FIG. 1 , the medical device or dissecting device  100  is guided into the subintimal (or intima space)  30  of the blood vessel  10  with the directional guide member  130  and the stenosed region  12  is cut with the cutting member  110  of the dissecting device  100 . Advantageously, the medical device or dissecting device  100  as disclosed herein can cut a stenotic region  40  in only a true lumen side  50 . In addition, the medical device or dissecting device  100  by cutting the stenosed site  40  can safely perform the atherectomy from a subintimal space (or outer intimal layer), which enables the dissecting device  100  to increase a size of the lumen  14  of the blood vessel  10  for improved blood flow. 
     The medical device  100  according to the first embodiment of the present disclosure can be used for therapy (treatment) to cut a stenosed site or an occluded site  12  which can be caused by a plaque, a fibrotic plaque, calculus, a blood clot, or a thrombus  40  inside the blood vessel  10 . In this description, a side of the device  100 , which is inserted into the blood vessel  10 , is referred to as a “distal side” or “distal end”, and an operating hand side is referred to as a “proximal side” or “proximal end”. The blood vessel (or artery)  10  comprises the tunica adventitia (or adventitia for short), which is the outermost tunica (layer) of a blood vessel  10 , and surrounds the tunica media (or media), which is the middle layer of the blood vessel or artery. Reference number  20  collectively identifies the adventitia and the media. As shown, the subintimal (or intima)  30  is the inner most layer of the blood vessel or artery  10 , and is surrounded by the adventitia and the media  20 . The subintimal  30  has an inner surface or inner side  32  and an outer surface or outer side  34 . 
       FIG. 2A  is a perspective view of the dissecting device  100  in accordance with the first exemplary embodiment. As shown in  FIG. 2A , the dissecting device includes a directional guide member  130  having a wire lumen  140  therein configured to receive a guide wire  150 . The dissecting device  100  also includes the cutting member  110  and the tubular member  120 , which is located on the proximal side of the cutting member  110 . In accordance with an exemplary embodiment, the directional guide member  130  is located on a distal side of the cutting member  110  and the tubular member  120 . The cutting member  110  and the tubular member  120  preferably has an oval or round outer diameter  111 ,  121  having a similar radius of curvature of a blood vessel  10  so that during cutting of the stenosed region  40 , the cutting member  110  and tubular member  120  do not rotate within the blood vessel  10 . 
     In accordance with an exemplary embodiment, a lower surface  137  of the directional guide member  130  can be relatively flat, can have convex or round shape, which generally mirrors an inner diameter of the blood vessel  10 . Alternatively, in accordance with an exemplary embodiment, at least a distal portion of the directional guide member  130  can rotates about a central axis (not shown) thereto with a relatively flat or slight upward trend, for example, trending upward from the proximal end  134  to the distal end  132  at an angle of less than about 30 degrees, and more preferably about 10 to 25 degrees. 
       FIG. 2B  is an end view of the dissecting device  100  as shown in  FIG. 2A  in accordance with an exemplary embodiment. As shown in  FIG. 2B , a cutting edge  112  of the cutting member  110  has a generally oval or round shape thereto. In accordance with an exemplary embodiment, the directional guide member  130  can have a rounded distal end with a guide wire lumen  140 . In accordance with an exemplary embodiment, the directional guide member  130  can have a rounded outer diameter, which generally is narrowed at the distal end of the guide member  130  and expands outward moving a proximal direction towards the cutting member  110 . 
       FIG. 2C  is a top view of the dissecting device  100  as shown in  FIGS. 2A and 2B  in accordance with an exemplary embodiment. As shown in  FIG. 2C , the directional guide member  130  extends from a distal end  114  of the cutting member  110  having a greater width at a proximal end extending to a distal end or tip of the guide member  130 . In accordance with an exemplary embodiment, the proximal end of the directional guide member  130  and at least a proximal portion of the directional guide member  130  are located on an outer surface of the cutting member  110 . The directional guide member  130  can have a width  131 , for example, of about 1.2 mm to 6.0 mm at a proximal end  134  and a width  139 , for example, of about 0.40 mm to 1.2 mm at distal end of the cutting member  110 , a thickness  133 , for example, of about 0.40 mm to 2.0 mm, and a length  135 , for example, of about 3.0 mm to 30 mm. 
     In accordance with an exemplary embodiment, an outer diameter  111 ,  121  of the cutting member  110  and the tubular member  120  can be between about 1.0 mm to about 6.0 mm in diameter. An inner diameter  113 ,  123  of the cutting member  110  and the tubular member  120  can be, for example, between about 0.8 mm to about 5.9 mm in diameter. In addition, the cutting member  110  can have a length  115  of, for example, about 1.0 mm to 15 mm, and the tubular member  120  can have a length  125  of, for example, about 150 mm to 3000 mm. 
       FIG. 3  is a plan view illustrating a guide wire  150  in a stenosed site  12  with a subintimal space wiring with optional re-entry in accordance with an exemplary embodiment. In accordance with an exemplary embodiment, as shown in  FIG. 3 , a guide wire  150  can be inserted into a subintimal space  30  within the blood vessel  10 , for example, entering the subintimal space on a proximal side  42  of the stenosis  40  and exiting from subintimal space on a distal side  44  of the stenosis  40 . 
       FIG. 4  is a plan view illustrating the dissecting device  100  in the stenosed site  12  performing the atherectomy of the stenosis  40  in accordance with an exemplary embodiment. As shown in  FIG. 4 , the dissecting device  100  is placed on the guide wire  150  and moves from the proximal end  42  of the stenosis  40  through the stenosis  40  to the distal end  44  of the stenosis  40  cutting out the stenosis  40  as the dissecting device  100  moves distally. The stenosis  40  that has been cut is then removed from the blood vessel  10  in each of the exemplary embodiments. 
       FIGS. 5A-5C  is a perspective view, an end view, and a top view, respectively, of a dissecting device  100  having a directional guide member  130  with horizontal stabilization  160  in accordance with an alternative exemplary embodiment. As shown in  FIGS. 5A-5C , the directional guide member  130  has a pair of flanges  162 , which extends radially outward from each of side edge  164  of the guide member  130 . In accordance with an exemplary embodiment, the pair of flanges  162  has a curvature thereto such that the directional guide member  130  has a radially extending convex shape thereto. Alternatively, the pair of flanges  162  can be relatively flat or horizontal forming a relatively radially extending flat structure, for example, as shown in  FIGS. 6A-6C . 
       FIGS. 6A-6C  is a perspective view, an end view, and a top view, respectively, of a dissecting device  100  in accordance with another alternative exemplary embodiment. As shown in  FIGS. 6A-6C , the directional guide member  130  can be a relatively flat or horizontal plate  170  having an outer edge  172  which generally has a round or oval shape. Alternatively, as shown in  FIGS. 6A-6C , the outer edges  172  of the plate  170  can be slightly curved radially extending upward such that the horizontal plate  170  has a convex shape ( FIG. 5 ). 
       FIGS. 7A-7C  is a perspective view, an end view, and a top view, respectively, of a dissecting device  100  in accordance with a further exemplary embodiment. As shown in  FIGS. 7A-7C , the directional guide member  130  includes a micro blade (or vertical stabilizer)  180 , which provides vertical stabilization to the directional guide member  130  and an elastomeric cover  190  which covers a portion of the micro blade  180  such that a tip or edge  182  of the micro blade  180  does not protrude through a distal portion or distal surface  192  of the elastomeric cover  190  in a non-compressed state, for example, with the absence of a front force caused by pushing the dissecting device  100  through the stenosed site  40 . In accordance with an exemplary embodiment, the elastomeric cover  190  can be made from silicone, polyurethane, or latex. In accordance with an exemplary embodiment, for example, the elastomeric cover  190  can be a blade spring, for example, a metal spring. 
     In accordance with an exemplary embodiment, the cutting member  110  can be made of stainless steel (SUS), Nickel titanium alloy or Nitinol (NiTi), tungsten carbide (WC), or high-speed steel. The tubular member  120  can be made of polyimide, polyether ether ketone (PEEK), nylon, polyurethane, blade-tube, for example, a weaved tube with a composite of weaved wire and polymer, metal coil covered by heat shrink tube, or composed of a combination of these material. The directional guide member  130  can be stainless steel (SUS), polyimide, Peek, Nylon, polyurethane, or composed of a combination of these materials. 
       FIGS. 8A-8C  is a perspective view, an end view, and a top view, respectively, of a dissecting device  100  as shown in  FIGS. 7A-7C  with a front force pushing into the subintimal space in accordance with an exemplary embodiment. As shown in  FIGS. 8A-8C , upon a force, for example, upon being pushed or forced through the subintimal space  30 , the distal end  192  of the elastomeric material  190  moves proximally, which exposes the tip or edge  182  of the micro blade  180 . As shown, upon application of a force  60  to the elastomeric material  190 , the micro blade  180  extends to distal side of the elastomeric material  190 . 
       FIGS. 9A and 9B  is an end view and a perspective view, respectively, of a dissecting device  100  in accordance with a further embodiment of the first exemplary embodiment. As shown in  FIGS. 9A and 9B , the distal end  132  of the directional guide member  130  has a tip  200 , which is placed in front (or distally) of the cutting member  110 . In accordance with an exemplary embodiment, the tip  200  can be relatively flat with a sharp edge or point. In accordance with an exemplary embodiment, the directional guide member  130  is preferably angled upwards, for example, extending upwards from a proximal end  134  of the directional guide member  130  towards the distal end  132 . The tip  200  is preferably located on a lower surface  136  of the directional guide member  130  just beneath the guide wire lumen  140 . In accordance with an exemplary embodiment, the distal end  202  of the tip  200  can be angled upward and having a convex lower surface  204 , for example, as a crescent moon like shape. 
       FIG. 10  is a plan view of the dissecting device  100  of  FIGS. 9A and 9B  in accordance with an exemplary embodiment. As shown in  FIG. 10 , the tip  200  is located on the distal end  132  of the directional guide member  130  just below or beneath the guide wire lumen  140  on the lower surface  137  of the directional guide member  130 . In accordance with an exemplary embodiment, the tip  200  is preferably made of a material having sufficient hardness to break through the subintimal space  30 . In accordance with an exemplary embodiment, the tip  200  can be made of a metal, for example, stainless steel (SUS), Nickel titanium alloy or Nitinol (NiTi), tungsten carbide (WC), or high-speed steel, or a polymer, for example, polyimide, polyether ether ketone (PEEK), nylon, or polyurethane. 
       FIG. 11  is a plan view of the directional guide member  130  having a tip  200  as shown in  FIG. 10  in an inactive state in accordance with an exemplary embodiment. As shown in  FIG. 11 , in the inactive state, the guide wire  150  extends distally beyond the distal end  132  of the directional guide member  130  and the tip  200 . 
       FIG. 12  is a plan view of the directional guide member  130  as shown in  FIG. 10  in an active state in accordance with an exemplary embodiment. As shown in  FIG. 12 , in the active state, the guide wire  150  is proximal to the tip  200  and housed within the guide wire lumen  140  of the directional guide member  130 . 
       FIGS. 13A-13C  are plan views of the dissecting device  100  having a tip  200  on the distal end  132  of the directional guide wire  130  as shown in  FIGS. 9A-12 . As shown in  FIG. 13A , for example, the subintimal space wiring or guide wire  150  is introduced into the subintimal space  30 . In  FIG. 13B , the dissecting device  100  is placed on the guide wire  150  and is advanced through the subintimal space  30 , and for example, performs an atherectomy. In  FIG. 13B , the tip  200  of the dissecting device  100  is the inactive state as shown in  FIG. 11 . In  FIG. 13C , the dissecting device  100  performs a re-entry using atherectomy in which the tip  200  of the dissecting device  100  is the active state as shown in  FIG. 12 . 
       FIGS. 14A and 14B  is a perspective view and an end view, respectively of a dissecting device  100  having a bellow structure  200  in accordance with an alternative embodiment of the first exemplary embodiment. As shown in  FIGS. 14A and 14B , the dissecting device  100  includes the directional guide member  130  having a wire lumen  140  therein configured to receive a guide wire  150 . The dissecting device  100  also includes the cutting member  110  and the tubular member  120 , which is located on the proximal side of the cutting member. In use, the directional guide member  130  is located on a distal side of the cutting member  110  and the tubular member  120 . In accordance with an exemplary embodiment on an upper portion  212  of a distal portion  216  of the tubular member  120 , a set or a plurality of bellows  220  are located. The set or plurality of bellows  220  are preferably arranged on the upper portion  212  of the tubular member  120 , which allows the tubular member  120  to expand and contract. In accordance with an exemplary embodiment, the series or plurality of bellows  220  extend from the upper portion  212  of the tubular member distally to a lower portion  214  of the tubular member  120 , which allows the upper portion  212  to expand and contract toward a proximal end of the dissecting device  200 . 
       FIGS. 15A and 15B  are perspective views of the dissecting device  100  with a bellow structure  200  as shown in  FIG. 14A-14B  under threshold and over threshold, respectively. As shown in  FIG. 15A , when under threshold, for example, a predetermined amount of force in which the bellows  220  are fully expanded. As shown in  FIG. 15B , when the dissecting device  100  is over threshold, for example, the amount of predetermined force is exceed during atherectomy, the bellows  220  contract, which causes the distal end  132  of the directional guide member  130  to raise upward. In accordance with an exemplary embodiment, the amount of force exerted against the dissecting device  100 , for example, can be based on an amount of force exerted against the distal end  132  of the directional guide member  130  and the cutting member  110 . 
       FIG. 15C  is a perspective view of the dissecting device  100  with a bellow structure  200  as shown in  FIG. 14  with a coil type drive shaft (or coiled drive shaft)  240  in accordance with an exemplary embodiment. As shown in  FIG. 15C , instead of bellows  220  expanding and contracting based on whether the dissecting device  100  and the bellows  220  are under threshold or over threshold, the tubular member  120  can include a coil type drive shaft  240 , which can straighten the tubular member  120 , for example, by rotating the drive shaft  240  in a clockwise direction, or alternatively, shorten the tubular structure  120 , for example, by rotating the drive shaft  240  in a counterclockwise direction. In accordance with an exemplary embodiment, by rotating the drive shaft  240  in a clockwise or counterclockwise direction, the amount of expansion or contraction of the bellow structure  200  can be controlled without regards to the amount of force exerted against the distal end  132  of the directional guide member  130  and the cutting member  110 . 
       FIGS. 16A-16C  are a perspective view, an end view, and a top view, respectively, of the dissecting device  100 , which includes the cutting member  110 , the directional guide member  130 , and an imaging guide  1600  for atherectomy in accordance with an exemplary embodiment. As shown in  FIGS. 16A-16C , the imaging guide  1600  can be an imaging portion or an image sensor  1600  located within the directional guide member  130 . In accordance with an exemplary embodiment, for example, the imaging guide  1600  can be located between the distal end of the directional guide member  130  and the distal end of the cutting member  120 . In accordance with an exemplary embodiment, the directional guiding structure  130  (for example, the tip of the guide member  130 , or alternatively, the cutting part of the guiding member  130 ) can include the imaging portion  1600 , which can help the physician, such that the cutting member  120  is not deployed toward the inner surface of the vessel. In other words, the imaging portion  1600  can help the physician deploy the guiding member  130  toward the false lumen of the vessel. 
     In accordance with an exemplary embodiment as shown in  FIG. 16D , the imaging sensor  1600  can allow the physician to observe the direction of the dissecting device  100  on the imaging device, for example, an OCT/IVUS, before the atherectomy procedure. In accordance with an exemplary embodiment, for example, if the direction of the cutting member  110  of the dissecting device  100  is opposite to the stenotic site, for example, as shown in  FIG. 16I , the physician can change the direction of the cutting member  110  to the correct side. In addition, the imaging sensor (or imaging guide)  1600  can help reduce perforation risk and improve its debulking efficiency of the dissecting device  100 . 
       FIG. 17  is a perspective view illustrating a dissecting device  300  comprising a directional guide member  330  in the subintimal space and a cutting member  310  and tubular member  320  which slide on the directional guide member  330  in accordance with a second exemplary embodiment. Note that, in the dissecting member  300  according to the second embodiment, elements having functions and effects the same as or similar to those of the dissecting member  100  according to the first embodiment, are denoted with the same reference signs, and the duplicate descriptions thereof will be omitted. As shown in  FIG. 17 , rather than the directional guide member  130 , the cutting member  110 , and the tubular member  120  moving as a single unit on the guide wire  150  in the second exemplary embodiment, the cutting member  310  and the tubular member  320  slide on the directional guide member  330 , for example, in the subintimal space  30  from a position “a”  302  to a position “b”  304  located on the distal end of the directional guide member  130 . 
       FIG. 18  is a perspective view of the dissecting device  300  as shown in  FIG. 17  in accordance with an exemplary embodiment. As shown in  FIG. 18 , the dissecting device  300  includes the directional guide member  330 , and a cutting member  310  and a tubular member  320  which are slidable on the directional guide member  330 . In accordance with an exemplary embodiment, the directional guide member  330  includes a guide wire lumen  340  on at least a distal portion of the directional guide member  330 . 
       FIG. 19  is an end view of the dissecting device  300  as shown in  FIG. 18  in accordance with an exemplary embodiment. As shown in  FIG. 18 , the cutting edge  312  of the cutting member  310  has a generally oval or round shape thereto. In accordance with an exemplary embodiment, the directional guide member  330  can have a rounded distal end with a guide wire lumen  340  located therein. In accordance with an exemplary embodiment, the directional guide member  330  can have a rounded outer diameter, which generally is narrowed at the distal end  332  of the guide member  330  and expands outward moving in a proximal direction towards the cutting member  310 . 
       FIG. 20  is a top view of the dissecting device  300  as shown in  FIGS. 18 and 19  in accordance with an exemplary embodiment. As shown in  FIG. 20 , the directional guide member  330  extends from a distal end  314  of the cutting member  310 . In accordance with an exemplary embodiment, the width of the directional guide member  330  can be generally constant with a rounded or oval distal end  332 . In addition, the directional guide member  330  has a guide track (or groove)  350  configured to receive a guide member  374  ( FIG. 23C ) extending from a lower edge or surface of the cutting member  310 . 
       FIGS. 21A-21C  are a series of views illustrating the dissecting device  300  as shown in  FIGS. 18-20  in use in accordance with an exemplary embodiment. As shown in  FIG. 21A , the guide wire  150  is inserted into the blood vessel  10  and through the subintimal space  30  (step  1 ). As show in  FIG. 21B , the directional guide member  330  is then placed onto the guide wire  150  and advance into the blood vessel  10  to a distal end side of the stenosis  40  (step  2 ). In  FIG. 21C , the cutting member  310  and tubular member  320  are placed within a guide track (or groove)  350  on the directional guide member  330  and advanced to the stenosis  40  and cuts or removes the stenosis  40  beginning on the proximal end  42  (position a) of the stenosis  40  through the distal end  44  (position b). 
       FIG. 22A  is a perspective view illustrating the directional guide member  330  of the dissecting device  300  in accordance with an exemplary embodiment. As shown in  FIG. 22A , the directional guide member  330  includes a guide track or groove  350 , which is configured to receive a guide member  374  ( FIG. 23C ) on a lower edge of the cutting member  310 . The guide track  350  includes a receiving slot  352  and a guide track  354 . The receiving track  352  is configured to allow the corresponding guide member  374  on the lower edge of the cutting member  310  to slide along the guide track  354  from entry into the blood vessel  10  through cutting of the stenosis  40 . In accordance with an exemplary embodiment, a width of the receiving track  352  is less than a width of the guide track  354  such that once the corresponding guide member  374  is placed within the guide track  350 . 
       FIG. 22B  is a perspective view illustrating a cutting member  310  and a tubular member  320  having a bellow structure  220  in accordance with an exemplary embodiment. As shown in  FIG. 22B , in accordance with an exemplary embodiment, on an upper portion  212  of a distal portion  216  of the tubular member  320 , a set or series of bellows  220  are located. The bellows  220  are arranged on the upper portion  312  of the tubular member  320 , which allows the tubular member  320  to expand and contract. In accordance with an exemplary embodiment, the series of bellows  220  extend from the upper portion  312  of the tubular member distally to a lower portion  314  of the tubular member  320 , which allows the upper portion  312  to expand and contract in a proximal direction. 
       FIG. 22C  shows perspective views of the cutting member  310  and the tubular member  320  with a bellow structure  220  sliding along the guide member  330 . As shown in  FIG. 22C , once the cutting member  310  and the tubular member  320  reach a distal end of the guide track  350 , a distal end of the cutting member  310  raises upward as the bellows  220  contract. As shown in  FIG. 22C , a distal portion  336  of the guide member  330  includes a guide wire lumen  340 . In accordance with an exemplary embodiment, the guide wire lumen  340  can rise slightly upward from a proximal side to a distal side of the distal portion  336  of the guide member  330 . 
       FIG. 22D  is a top view of the guide member  330  of the dissecting device  300  as shown in  FIGS. 22A-22C  in accordance with the second exemplary embodiment. As shown in  FIG. 22D , the directional guide member  330  includes the guide track or groove  350 , which is configured to receive the guide member  374  ( FIG. 23C ) on a lower edge of the cutting member  310 . The guide track  350  extends from a proximal end  334  of the guide member  330  towards the distal end  332  of the guide member  330 . On a distal portion  336  of the guide member  330 , the guide track  350  ends such that the cutting member  310  and tubular member  320  can to stop and can be contained within the guide track  350  during use. In addition, the guide member  330  includes a guide wire lumen  340 , which is located on a distal side of the end of the guide track  350  within the distal portion  336  of the guide member  330 . As shown in  FIG. 22A , the receiving track  352  is configured to allow the corresponding guide member  374  on the lower edge of the cutting member  310  to slide along the guide track  354  from entry into the blood vessel  10  through cutting of the stenosis  40 . 
       FIG. 23A  is a cross-sectional view of the guide member along the line XXIIIA-XXIIIA as shown in  FIGS. 22A and 22D  in accordance with two exemplary embodiments of the dissecting device in accordance with the first exemplary embodiment. As shown in  FIG. 23A , the distal side of the distal portion of the guide member  330  can have a generally oval shape having a guide wire lumen  340 , or alternatively, for example, can be a crescent moon shape having a generally rounded (or convex) outer edge on a lower surface  339  thereof and a concave edge on an upper surface  338  thereof. For example, in accordance with an exemplary embodiment, the lower surface  339  of the guide member  330  can have a shaped, which matches an inner wall of the subintimal (or intima)  30 . 
       FIG. 23B  is a cross-sectional view of the guide member along the line XXIIIB-XXIIIB as shown in  FIGS. 22A and 22D  in accordance with the first exemplary embodiment. In accordance with an exemplary embodiment, as shown in  FIG. 23B , the portion of the guide member  330 , which houses the guide track  350 , can have a generally rectangular outer shape as shown. Alternatively, the guide member  330  in the portion which house the guide track  350  can be oval or crescent moon shaped as shown in  FIG. 23A . In accordance with an exemplary embodiment, the portion of the guide member  330 , which houses the guide track can have, for example, a shaped, which matches an inner wall of the subintimal (or intima)  30 . 
       FIG. 23C  is a cross-section view along the line XXIIIC-XXIIIC as shown in  FIG. 22B  of the tubular member  320  in accordance with an exemplary embodiment. As shown in  FIG. 23C , the tubular member  320  has a generally round or oval outer diameter. On a lower edge  322  of the tubular member  320 , an extension member  372  extends from the lower edge  322  of the tubular member  320  to a guide member  374 , which is configured to slide within the guide track  350 . In accordance with an exemplary embodiment, the guide member  374  is configured to match the guide track  350 . For example, in accordance with an exemplary embodiment the guide member  374  has an oval outer diameter, which matches an oval diameter of the guide track  350 . 
       FIG. 24A  is a perspective view illustrating the dissecting device  300  with re-entry by a cutting member  310  in accordance with another exemplary embodiment. As shown in  FIG. 24A , the directional guide member  330  includes a guide track or groove  350 , which is configured to receive a guide member  370  ( FIG. 25C ) on a lower edge  312  of the cutting member  310 , for example, on a proximal side of the tubular cutting member  310 , or alternatively, the guide member  370  can be located on the lower edge  322  of the tubular member  320  as shown, for example, in  FIGS. 22B and 22C . The guide track  350  includes a receiving slot  352  and a receiving track  354 . The receiving slot  352  is configured to allow the corresponding guide member  370  on the lower edge of the cutting member  310  to slide along the receiving track  354  from entry into the blood vessel  10  through cutting of the stenosis  40 . In accordance with an exemplary embodiment, a width of the receiving slot  352  is less than a width of the receiving track  354  such that once the corresponding guide member  370  is placed within the guide track  350 . In accordance with an exemplary embodiment, the guide member  370  can include a first member  372  extending from a lower surface  312 ,  322  of the cutting member  310  or the tubular member  320 , and a second member  374  configured to slide within the receiving track  354 . 
       FIG. 24B  is a perspective view illustrating the dissecting device  300  with re-entry by a cutting member  310  in accordance with an exemplary embodiment. As shown in  FIG. 24B , in accordance with an exemplary embodiment, on a lower edge of the cutting member  310 , a micro-needle  360  with an elastic material  362  on a proximal side of the micro-needle  360 . 
       FIG. 24C  shows perspective views of the dissecting device  300  as the cutting member  310  and tubular member  320  slide along the guide member  330 . As shown in  FIG. 24C , once the cutting member  310  and the tubular member  320  reach a distal end of the guide track  350 , a distal end of the cutting member  310  with the micro-needle  360  raises upward as the cutting member  310  contacts a distal end of the guide track  350 . As shown in  FIG. 24C , a distal portion  336  of the guide member  330  includes a guide wire lumen  340 . In accordance with an exemplary embodiment, the guide wire lumen  340  can rise slightly upward from a proximal side to a distal side of the distal portion  336  of the guide member  330 . 
       FIG. 24D  is a top view of the guide member  330  of the dissecting device  300  as shown in  FIG. 24A  in accordance with the second exemplary embodiment. As shown in  FIG. 24D , the guide member  330  includes the guide track or groove  350 , which is configured to receive the guide member  374  ( FIG. 25C ) on a lower edge of the cutting member  310 . The guide track  350  extends from a proximal end  334  of the guide member  330  towards the distal end  332  of the guide member  330 . On a distal portion  336  of the guide member  330 , the guide track  350  ends such that the cutting member  310  and tubular member  320  can to stop and can be contained within the guide track  350  during use. In addition, the guide member  330  includes a guide wire lumen  340 , which is located on a distal side of the end of the guide track  350  within the distal portion  336  of the guide member  330 . As shown in  FIG. 25B , the receiving track  352  and the receiving track  354  are configured to allow the corresponding first member  372  and second member on the lower edge of the cutting member  310  to slide along the guide track  350  from entry into the blood vessel  10  through cutting of the stenosis  40 . 
       FIG. 25A  is a cross-sectional view of the guide member along the line XXVA-XXVA as shown in  FIGS. 24A and 24D  in accordance with two exemplary embodiments of the dissecting device in accordance with the first exemplary embodiment. As shown in  FIG. 25A , the distal side of the distal portion of the guide member  330  can have a generally oval shape having a guide wire lumen  340 , or alternatively, for example, can be a crescent moon shape having a generally rounded (or convex) outer edge on a lower surface  339  thereof and a concave edge on an upper surface  338  thereof. For example, in accordance with an exemplary embodiment, the lower surface  339  of the guide member  330  can have a shape, which matches an inner wall of the subintimal (or intima)  30 . 
       FIG. 25B  is a cross-sectional view of the guide member along the line XXVB-XXVB as shown in  FIGS. 24A and 24D  in accordance with the first exemplary embodiment. In accordance with an exemplary embodiment, as shown in  FIG. 25B , the portion of the guide member  330 , which houses the guide track  350 , can have a generally rectangular outer shape as shown. Alternatively, the guide member  330  in the portion which house the guide track  350  can be oval or crescent moon shaped as shown in  FIG. 23A . In accordance with an exemplary embodiment, the portion of the guide member  330 , which houses the guide track  350  can have, for example, a shape, which matches an inner wall of the subintimal (or intima)  30 . 
       FIG. 25C  is a cross-section view along the line XXVC-XXVC as shown in  FIG. 24B  of the tubular member  320  in accordance with an exemplary embodiment. As shown in  FIG. 25C , the tubular member  320  has a generally round or oval outer diameter. On a lower edge  322  of the tubular member  320 , an extension member  372  extends from the lower edge  322  of the tubular member  320  to a guide member  374 , which is configured to slide within the guide track  350 . In accordance with an exemplary embodiment, the guide member  370  is configured to match the guide track  350 . For example, in accordance with an exemplary embodiment the second member  374  of the guide member  370  has an oval outer diameter, which matches an oval diameter of the receiving track  354  of the guide track  350 . In accordance with an alternative exemplary embodiment, rather than being connected to the tubular cutting member  310 , the guide member  370  can be attached to a lower surface of the tubular member  320 . 
       FIG. 26  is a plan view of a dissecting system  400  in accordance with an exemplary embodiment having a cutting member (or first dissecting member)  420  and a second dissecting member  410 , and wherein the second dissecting member  410  is shown in a bent state in accordance with a third exemplary embodiment. Note that, according to the third embodiment, elements having functions and effects the same as or similar to those of the dissecting member  100 ,  300  according to the first and second embodiments, are denoted with the same reference signs, and the duplicate descriptions thereof will be omitted. 
     As shown in  FIG. 26 , a guide wire  150  is inserted into the blood vessel  10  and the subintimal space  30 . The dissecting system  400  includes the second dissecting member  410  and a cutting device (or first dissecting member)  420 , and the dissecting system  400  is guided to the stenosed site  40  by the guide wire  150 . As shown in  FIG. 26 , the second dissecting member  410  in a bent state moves over the whole (or entire) circumference between an inner side  32  of the subintimal space  30  and the outer side  34  of the subintimal space  30  to cut or dissect at least a portion of the stenosed site  40 . In accordance with an exemplary embodiment, the second dissecting member  410  can be an elongated wire  412 , for example, having an outer diameter of 0.018 to 0.035 inches, for example, 0.018 inches or 0.035 inches made of stainless steel and/or nickel titanium alloy or Nitinol (NiTi), and with or without a hydrophilic polymer coating or Teflon® coating. 
       FIG. 27  is a cross-sectional view of a blood vessel  10  as shown in  FIG. 26  in which the second dissecting member  410  is in a bent state in accordance with the third exemplary embodiment. As shown in  FIG. 27 , the guide wire  150  is inserted into the subintimal space  30 , which guides the dissecting system  400  to the stenosed site  40 . In accordance with an exemplary embodiment, the second dissecting member  410  can be positioned between an inner side of the subintimal space and an outer side of the subintimal space. During atherectomy, the second dissecting member  410  dissects the inner side of the subintimal space (stenotic region) over the whole (or entire) circumference and removes the inner side  32  of the subintimal space  30  (and/or stenotic region  40 ) from the blood vessel  10 . In accordance with an exemplary embodiment, by dissecting the stenotic region  40  from the blood vessel  10 , a larger lumen  12  can be obtained for improved blood flow. 
       FIGS. 28A and 28B  are plan views of a dissecting member  500 , which includes an expandable balloon  510  within a blood vessel  10  in accordance with an exemplary embodiment. As shown in  FIG. 28A , the dissecting member  500  includes an expandable balloon  510 , which is positioned on a distal portion of a dissecting member  410 . In accordance with an exemplary embodiment, the dissecting member  500  is inserted into the blood vessel and through the subintimal space  30  from a proximal side  42  to a distal side  44  of the stenosed site  40  such that the balloon  510  is positioned on a distal side of the stenosed site  40 . Once the balloon  510  of the dissecting member  400  is positioned on the distal side of the stenosed site  40 , the balloon  510  is expanded to lock or fix the balloon  510  within the blood vessel  10 . 
     In accordance with an exemplary embodiment as shown in  FIG. 28B , the dissecting wire  410  is pushed into the blood vessel  10  such that dissecting wire  410  moves in a circumferential direction of the subintimal space  30  in a bent state to remove the inner side  32  of the subintimal space  30  (and/or stenotic region  40 ) from the blood vessel  10 . The dissected inner side  32  of the subintimal space  30  and a stenotic region  40  attached to the inner side  32  of the subintimal space  30  from the blood vessel  10  is then removed. 
       FIG. 29  is a plan view of a cutting device (or first dissecting device)  420  in accordance with an exemplary embodiment. As shown in  FIG. 29 , the cutting device  420  can be an elongated member  422  having a lumen  440  extending from a proximal end  426  of the elongated member  422  to the distal end  424  of the elongated member. The lumen  440  can be configured to be place on a guide wire  150  (not shown). 
       FIG. 30  is a top view of the cutting device  410  of  FIG. 29  in accordance with an exemplary embodiment. As shown in  FIG. 30 , the cutting device  420  includes a cutting blade  430  for distal end incision, and wherein the cutting blade  430  is arranged with a cutout  430  on a distal portion of the cutting device  420 . 
       FIGS. 31A-31C  are a series of cross-sectional views of the cutting device  420  of  FIG. 30  and cross-sectional view along the lines XXXIA-XXXIA, XXXIB-XXXIB, and XXXIC-XXXIC in accordance with an exemplary embodiment. As shown in  FIGS. 31A-31C , the cutting device  420  preferably has an oval shape thereto having a width greater than height configured to be received within a blood vessel  10 . A distal end of the cutting device  420  narrows to a rounded distal end  418 . The lumen  440  within the cutting device is preferably positioned within a center portion of the cutting device  420 . As shown in  FIG. 31B , in a distal portion of the cutting device  420 , a portion of the elongated member  420  is removed to house the cutting blade  430  for distal end incisions. As shown in  FIG. 31C , the cutting device  420  has a generally oval shape having a width greater than a height thereof. 
     In accordance with an exemplary embodiment, the cutting device  420  can have a width  421  of about 1.0 mm to about 7.0 mm and a thickness (or depth)  423  of about 0.4 mm to about 2.0 mm. In accordance with an exemplary embodiment, the cutting blade  430  located at the tip has a width  425  of about 0.2 mm to 10 mm, and a thickness (or depth)  427  of about 0.5 mm to about 3.0 mm. 
       FIG. 32  is a plan view of the dissecting member  400  as a balloon wire  500  as shown in  FIG. 29  with a cutting device  420  as shown in  FIGS. 30-31C  in accordance with an exemplary embodiment. As shown in  FIG. 32 , the dissecting member  400  cuts the end of the subintimal space  30  by moving in a circumferential direction or an axial direction of the cutting device  420 . In accordance with an exemplary embodiment, in the case of moving in circumferential direction, the cutting device  420  is rotated in the circumferential direction of the subintimal space  30 . In the case of the axial direction, the cutting device  420  can be moved distally and proximally repeatedly. For example, in accordance with an exemplary embodiment, the distal and proximal movement at one or more different orientations. 
       FIG. 33  is a cross-section view of a dissecting system  600  having a cutting device (or first dissecting member)  620  having a side port  650  ( FIG. 34 ) for a second dissecting member  410  and an incision portion  630  having a cutting blade  632  in accordance with another exemplary embodiment. As shown in  FIG. 33 , the cutting member  600  includes a second lumen  640  configured to receive the second dissecting member  410  in the form of a wire  412 . 
     In accordance with an exemplary embodiment, the cutting device  620  can be an elongated member  622  having a first lumen  440  extending from a proximal end  426  of the elongated member  422  to the distal end  424  of the elongated member  622  and configured to receive a guide wire  150 , and a second lumen  640  configured to receive a second dissecting member  410  in the form of a dissecting wire  412 . 
       FIG. 34  is a top view of the cutting device  620  of  FIG. 33  in accordance with an exemplary embodiment. As shown in  FIG. 34 , the cutting device  620  includes an incision portion  430  having a cutting blade  432  for distal end incision. In accordance with an exemplary embodiment, the cutting blade  432  can be arranged within the incision portion  430  on a distal portion of the cutting device  420 . In addition, the side port  650 , which is in communication with the second lumen  640  is configured to receive a dissecting wire  412  (or second dissecting member  410 ). 
     As shown in  FIG. 34 , the first lumen  440  of the cutting device  620  extends to a distal end of the cutting device  600 . The second lumen  640  is configured to receive and/or house an end of the second dissecting member  610  before reaching the distal end  424  of the cutting device  620  such that the second dissecting member  410 , for example, a wire  412 , cannot be pushed though the distal end  424  of the cutting device  620  during use. In accordance with an exemplary embodiment, the second dissecting member  410  in the form of a wire  412  can be fixed within the second lumen  640 , or alternatively, may not be fixed in the second lumen  640  and can be removed as needed. The first and second lumens  440 ,  640  preferably are arranged around a center portion of the elongated cutting device  600 . 
     In accordance with an exemplary embodiment, the second lumen  640  includes a side port  650  located on a proximal side of the cutting member  620 . The side port  650  is configured to allow the second dissecting member  410  in the form of a wire  412  to protrude from the second lumen  640  and into the stenosed site  40 . In accordance with an exemplary embodiment, the side port  640  is preferably rectangular in shape extending axially for, for example, between 1.5 mm to 0.15 mm. 
       FIGS. 35A-35D  are a series of cross-sectional views of the cutting device  620  of  FIG. 34  and cross-sectional view along the lines XXXVA-XXXVA, XXXVB-XXXVB, XXXVC-XXXVC, and XXXVD-XXXVD, respectively, in accordance with an exemplary embodiment. As shown in  FIGS. 35A-35D , the cutting device  620  preferably has an oval shape thereto having a width greater than a height thereto, and configured to be received with a blood vessel  10 . A distal end  424  of the cutting device  620  narrows to a rounded distal end  418 . As shown in  FIG. 35C , in a distal portion of the cutting device  420 , a portion of the elongated member  420  is removed to house the cutting blade  432  for distal end incisions. 
       FIG. 36  is a plan view of the dissecting member  600  with a cutting device  620  as shown in  FIGS. 33-35D  in accordance with an exemplary embodiment. As shown in  FIG. 36 , a guide wire  150  is inserted into the subintimal space  30  of the blood vessel  10  at a proximal side of the stenosed region  40  to a distal side of the stenosed site  40 . The dissecting member  600  is placed on the guide wire  150  and directed to the stenosed site  40 . The first and second dissecting members  620 ,  410  cut between the inner surface  32  and the outer surface  34  of the subintimal space  30  by moving in a circumferential direction, and/or an axial direction of the cutting device  620 . 
     In accordance with an exemplary embodiment, in the case of moving in circumferential direction, the cutting device  620  is rotated in the circumferential direction of the subintimal space. In the case of the axial direction, the cutting device  620  can be moved distally and proximally repeatedly. As shown in  FIG. 36 , the second dissecting member  410  in a bent state moves over the whole circumference between an inner side  32  of the subintimal  30  and the outer side  34  of the subintimal  30  to cut or dissect at least a portion of the stenosed site  40 . The dissected inner side  32  of the subintimal space  30  and the stenotic region  40  attached to the inner side  32  of the subintimal space  30  are then removed from the blood vessel  10  as disclosed herein. In accordance with an exemplary embodiment, the repeated procedure enables a physician to separate the stenotic region from the vessel wall. For example, afterwards, the physician can remove the cut or dissected portion of the stenosed site by micro forceps, a grasping catheter, snare catheter, aspiration catheter, Fogarty balloon embolectomy, and/or morcellator. 
       FIG. 37  is a perspective view of a dissecting device  700  having a first dissecting member  710  in the form of a directional guide member  130  and a second dissecting member  720  in the form of a side port  730  configured to receive a wire for a loop wire technique as disclosed herein. The dissecting device  700  includes the directional guide member  130  having a wire lumen  140  therein configured to receive a guide wire  150 , and the second dissecting member  720  includes a second lumen (or second dissecting lumen member)  740  ( FIG. 38 ) having a side port  730  ( FIG. 39 ) on an upper surface  732  of the directional guide member  130 . As shown in  FIG. 37 , the dissecting device  700  also includes the cutting member  110  and the tubular member  120 , which is located on the proximal side of the cutting member  110 . In use, the directional guide member  130  is located on a distal side of the cutting member  110  and the tubular member  120 . 
       FIG. 38  is an end view of the dissecting device  700  as shown in  FIG. 37  in accordance with an exemplary embodiment. As shown in  FIG. 38 , the cutting edge  112  of the cutting member  110  has a generally oval or round shape thereto. In accordance with an exemplary embodiment, the directional guide member  130  can have a rounded distal end with a guide wire lumen  140  and the second lumen  740 , which does not extend to a distal end  742  of the directional guide member  130 . 
       FIG. 39  is a top view of the dissecting device  700  as shown in  FIGS. 37 and 38  in accordance with an exemplary embodiment. As shown in  FIG. 39 , the second lumen  740  within the directional guide member  130  has a side port  730  configured to allow a wire  412  to protrude from the second lumen  740  and into the stenosed site  40 . In accordance with an exemplary embodiment, the side port  730  is preferably rectangular in shape extending axially for, for example, between 1.5 mm to 15 mm. 
       FIG. 40  is a series of cross-sectional view illustrating the use of the dissecting device as shown in  FIGS. 37-39  in a blood vessel  10  having a stenosed region  40 . As shown in  FIG. 40 , the dissecting device  700  can be inserted into the stenosed site  40  in one or more passes, for example, three passes in which during each pass, the directional guide member  130  is rotated in circumferential direction to help assist the wire  412  to separate the subintimal space  30  and the stenosed site  40  from the blood vessel  10 . For example, as shown in  FIG. 40 , for each pass, the directional guide member  130  can be inserted at 120 degrees to the previous pass. 
       FIG. 41  is a cross-sectional view illustrating the use of the dissecting device  800  in a blood vessel  10  having a stenosed region  12  in accordance with a fourth embodiment. As shown in  FIG. 41 , the dissecting device  800  includes an elongated cutting device  820 , which rotates over an entire or whole circumference between an inner side or surface  32  of the subintimal space  30  and an outside or outer surface  34  of the subintimal space  30 . 
       FIG. 42  is a perspective view of a cutting device  820  of the dissection device  800  shown in  FIG. 41  in accordance with an exemplary embodiment. As shown in  FIG. 42 , the cutting device  820  can be an elongated member  822  having a lumen  840  extending from a proximal end  826  of the elongated member  822  to the distal end  824  of the elongated member. In accordance with an exemplary embodiment, the lumen  840  can be configured to be placed on a guide wire  150  ( FIG. 41 ). 
       FIG. 43  is a top view of the cutting device  820  of  FIG. 42  in accordance with an exemplary embodiment. As shown in  FIG. 43 , the cutting device  820  includes an incision portion  830  having a cutting blade  832  for distal end incision. The incision portion  830  is generally arranged on a distal portion of the cutting device  820 . In addition, the cutting device  820  can include a convex structure  860  positioned distally to the cutting blade  832 , which extends outward from one side of the cutting device  820  and configured to assist the cutting device  820  with removal of the stenosed site  40  from the blood vessel  10 . 
       FIGS. 44A-44D  are a series of cross-sectional views of the cutting device  420  of  FIG. 43  and cross-sectional view along the lines XLIVA-XLIVA, XLIVB-XLIVB, XLIVC-XLIVC, and XLIVD-XLIVD, respectively, in accordance with an exemplary embodiment. As shown in  FIGS. 44A-44D , the cutting device  820  preferably has an oval shape thereto having a width greater than height configured to be received with a blood vessel  10 . A distal end of the cutting device  820  narrows to a rounded distal end  818 . The lumen  840  within the cutting device  820  is preferably positioned within a center portion of the cutting device  840 . As shown in  FIG. 44B , in a distal portion of the cutting device  820 , a portion of the elongated member  820  is removed to house the cutting blade  832  for distal end incisions. As shown in  FIG. 44C , the cutting device  820  include a convex structure  850  on an outer portion of the elongated member  820 , which can help remove cut or debulked material from a stenosed site  12 . 
       FIG. 45  is a plan view of the dissecting member  800  as shown in  FIGS. 42-44D  in accordance with an exemplary embodiment. As shown in  FIG. 45 , the dissecting member  800  cuts the end of the subintimal space by moving in a circumferential direction or in an axial direction of the cutting device  820 . In accordance with an exemplary embodiment, in the case of moving in circumferential direction, the cutting device  820  can be rotated in the circumferential direction of the subintimal space. During rotation of the cutting device  820 , the cutting blade  832  cuts or debulks the stenosed region  40 , and the convex structure  850  can help removed the cut or debulked material from the stenosed site  12 . In the case of the axial direction, the cutting device  820  can be moved before (distally) and after (proximally) repeatedly. 
       FIGS. 46 and 47  illustrate a series of end views, and a plan view, respectively, of exemplary method of removing a stenosed site  40  from a blood vessel  10  in accordance with an exemplary embodiment. As shown in  FIGS. 46 and 47 , the dissecting devices  100 ,  300  as shown in  FIGS. 2A-2C ,  FIGS. 5A-5C ,  FIGS. 6A-6C ,  FIGS. 7A-7C ,  FIGS. 8A-8C ,  FIGS. 9A-9B .  FIGS. 10-12 ,  FIGS. 14A-14B ,  FIGS. 18-20 ,  FIGS. 22A-23C ,  FIGS. 24A-25C , can be used by performing repeated atherectomy or a series of passes into and through the stenosed region  40 . For example, a first pass can be performed with the directional guide member  130  at a first position, for example, at 0 degrees, a second pass wherein the directional guide member  130  has been rotated 120 degrees from the first atherectomy, and a third pass, where the directional guide member  130  has been rotated 240 degrees from the first atherectomy. 
       FIGS. 48 and 49  illustrate a series of end views, and a plan view, respectively, of another exemplary method of removing a stenosed site  40  from a blood vessel  10 . As shown in  FIGS. 48 and 49 , the dissecting devices  100 ,  300  as shown in  FIGS. 2A-2C ,  FIGS. 5A-5C ,  FIGS. 6A-6C ,  FIGS. 7A-7C ,  FIGS. 8A-8C ,  FIGS. 9A-9B ,  FIGS. 10-12 ,  FIGS. 14A-14B ,  FIGS. 18-20 ,  FIGS. 22A-23C ,  FIGS. 24A-25C  as disclosed herein, can be used by performing atherectomy by a rotation or a spiral motion of the dissecting device  100 ,  300  into and through the stenosed region  40 . For example, in accordance with an exemplary embodiment, the dissecting devices  100 ,  300  as disclosed herein can be moved or pushed distally into the stenosed region  40  at the same time the dissecting device  100 ,  300  is rotated in a clockwise or counterclockwise direction, which can help enable the device  100 ,  300  to separate the subintimal  30  from the media  20  around an entirety or whole circumference of the blood vessel  10 . 
       FIG. 50  is a perspective view of a dissecting device  1000  in accordance with an alternative embodiment. As shown in  FIG. 50 , the dissecting device  1000  can include a directional guide member  130  having a wire lumen  140  therein configured to receive a guide wire  150 . The dissecting device  1000  can also include a second dissecting member  1010 , which extends from a second tubular member  1020 . In accordance with an exemplary embodiment, the second tubular member  1020  is arranged around an outer surface  121  of the tubular member  120 . In use, the directional guide member  130  is located on a distal side of the tubular member  120 . In accordance with an exemplary embodiment, the tubular member  120  can include an optional cutting member (not shown) arranged on a distal end of the tubular member  120 . In accordance with an exemplary embodiment, the tubular member  120  can include an optional cutting member (not shown) arranged on a distal end of the tubular member  120 . 
       FIG. 51  is an end view of the dissecting device as shown in  FIG. 50  in accordance with an exemplary embodiment. As shown in  FIG. 50 , the tubular member  120  has a generally oval or round shape thereto. In accordance with an exemplary embodiment, the directional guide member  130  can have a rounded distal end with a guide wire lumen  140  as disclose herein. In accordance with an exemplary embodiment, the directional guide member  130  can have a rounded outer diameter, which can be narrowed at the distal end of the guide member  130  and expands outward moving a proximal direction towards the cutting member  110 . 
     As shown in  FIG. 51 , the second dissecting member  1010  can be arranged and configured to extend distally from the second tubular member  1020 . The second dissecting member  1010  preferably includes a cutting member or blade  1012  on an axially extending rod or member  1014 . In accordance with an exemplary embodiment, the second tubular member  1020  is configured to rotate around the tubular member  120  such that the cutting member or blade  1012  on the axially extending rod  1014  can move proximally and distally relative to the directional guide member  130  in addition to rotating around the tubular member  120 . 
       FIG. 52  is series of end views showing the dissecting device  1000  as shown in  FIGS. 50 and 51  in a blood vessel  10  having a stenosed region  40 . As shown in  FIG. 52 , the dissecting device  1000  can perform an atherectomy by rotation or a spiral motion of the dissecting device  1000  into and through the stenosed region  40 . 
       FIG. 53  is a perspective view of the dissecting device  1100  in accordance with the first exemplary embodiment. As shown in  FIG. 53 , the dissecting device includes a directional guide member  130  having a wire lumen  140  therein configured to receive a guide wire  150 . The dissecting device  100  includes the cutting member  110  and the tubular member  120 , which is located on the proximal side of the cutting member  110 . In use, the directional guide member  130  is located on a distal side of the cutting member  110  and the tubular member  120 . As shown in  FIG. 53 , a side-cutting member or blade  1110  is arranged on an outer diameter  111  of the cutting member  110 . The side-cutting member or blade  1110  includes a blade or tip  1112 , which configured to cut in at least one direction, for example, a clockwise or a counterclockwise direction. In accordance with an exemplary embodiment, the side-cutting member or blade  1110  can be configured that the blade or tip  1112  cuts in both a clockwise and a counter clockwise direction. 
       FIG. 54  is an end view of the dissecting device  1100  as shown in  FIG. 53  in accordance with an exemplary embodiment. As shown in  FIG. 54 , a cutting edge  112  of the cutting member  110  has a generally oval or round shape thereto. In accordance with an exemplary embodiment, the directional guide member  130  can have a rounded distal end with a guide wire lumen  140 . In accordance with an exemplary embodiment, the directional guide member  130  can have a rounded outer diameter, which generally is narrowed at the distal end of the guide member  130  and expands outward moving a proximal direction towards the cutting member  110 . 
       FIG. 55  is series of end views showing the dissecting device  1100  as shown in  FIGS. 53 and 54  in a blood vessel having a stenosed region  40 . As shown in FIG.  55 , the dissecting device  1100  as disclosed herein can perform an atherectomy by rotation or a spiral motion of the dissecting device  1100  into and through the stenosed region  40 . As shown in  FIG. 55 , the dissecting device  1100  can be rotated about an entire circumference of the blood vessel (for example, 360 degrees) to separate the subintimal  30  from the media  20 . 
       FIG. 56  is a plan view of the dissecting member  1100  as shown in  FIGS. 53 and 54  in accordance with an exemplary embodiment. As shown in  FIG. 56 , the dissecting member cuts  1100  the end of the subintimal space by moving in a circumferential direction of the dissecting device  1100 . In accordance with an exemplary embodiment, in the case of moving in circumferential direction, the dissecting device  1100  is rotated in the circumferential direction of the subintimal space  30  such that the side cutting member or blade  1110  cuts or separated the subintimal  30  from the media  20  about an entirety (or 360 degrees) of the blood vessel  10 . 
     The detailed description above describes medical device and treatment methods for treating a stenotic vessel with atherectomy with the subintimal space. The invention is not limited, however, to the precise embodiments and variations described. Various changes, modifications and equivalents can effected by one skilled in the art without departing from the spirit and scope of the invention as defined in the accompanying claims. It is expressly intended that all such changes, modifications and equivalents which fall within the scope of the claims are embraced by the claims.