Patent Document

FIELD OF THE INVENTION 
       [0001]    The present invention relates to bypass grafts, and more particularly to a bypass graft device and system which can be inserted via a minimally invasive technique. 
       BACKGROUND OF THE INVENTION 
       [0002]    At times it is necessary to perform a bypass procedure when a vessel is occluded. These types of procedures are generally performed using autografts, allografts, xenografts or synthetic grafts, wherein one end of the graft is attached to an end of the occluded vessel which is proximal to the occlusion, and the other end of the graft is attached to a portion of the occluded vessel which is distal to the occlusion, thereby bypassing the occluded portion of the vessel. This type of procedure generally requires surgical access to both sites (ie, the area of the occluded vessel proximal to the occlusion and the area of the occluded vessel distal to the occlusion). 
         [0003]    In order to position a graft via a minimally invasive procedure, it is necessary to find a way to anchor the graft in the vessel without the need for suturing or other attachment means typically used in surgical procedures. 
         [0004]    Generally, devices have been developed for grafting wherein the graft is to provide an access path through an area having an aneurysm or blocked vessel. These types of grafts are generally inserted through a blood vessel which may be remote from the site of the aneurysm or blocked vessel. However, graft devices for bypass wherein the bypass site is accessed directly are not currently available. 
         [0005]    Several graft devices and methods for treating an aneurysm or blockage are disclosed. 
         [0006]    A graft having a branched side tube which can be inverted is disclosed in U.S. Pat. No. 6,814,747 to Anson et al. The graft/stent disclosed therein includes a plurality of ring-like rigid members having a contracted shape and an expanded shape. The inverted portion is re-inverted by pulling on a cord. A disadvantage of this design is that in order to pull on the cord, the cord must be accessed from the other side, requiring an additional access site. 
         [0007]    A single-piece bifurcated graft for insertion into the aorta is disclosed in U.S. Pat. No. 5,904,713 to Leschinsky. The graft has an inverted portion and no central section. Two bifurcated sections are joined at the top. Upon introduction, the graft is attached to the wall of the vessel in the middle section, and the inverted portion is un-inverted. Once in place, the two sections are roughly parallel. 
         [0008]    An intraluminal prosthesis is disclosed in U.S. Pat. No. 6,016,810 to Ravenscroft. The prosthesis includes a tubular, flexible graft having a proximal open end, and at least one distal open end terminating in a hem. The hem is inverted so that it is disposed as a cuff within the graft. Upon withdrawing the distal open end from inside the cuff, the cuff will unfold. The hem may be folded a second time to form a second cuff within the graft. Although deployment of the inverted portion may be accomplished by pushing rather than pulling, the additional folds in the graft material would likely result in a relatively large overall diameter for the system. 
         [0009]    The devices described above are used for providing a passage of blood in an area where blood flow may be compromised to due an aneurysm or blockage. A device used for bypass is disclosed in U.S. Pat. No. 6,575,168 to LaFontaine et al. The graft disclosed therein is used by making an incision in the aorta and an incision in a second vessel. The graft section is inverted and pushed through a coupler to reach the second vessel. The first end of the graft section may be anchored in the aorta via a stent, while the second end of the graft section is anchored by other means, such as adhesive, for example. 
         [0010]    It would be advantageous to have a device, system and method for a minimally invasive bypass procedure, which is small enough in diameter to be placed in relatively small vessels such as the femoral artery, which can be easily anchored in place, and which can be deployed without separately accessing another end of the device. 
       SUMMARY OF THE INVENTION 
       [0011]    In accordance with embodiments of the present invention, there is provided a device for positioning in a vessel. The device includes a supporting segment comprised of a flexible material having a substantially tubular configuration, a supporting member comprised of a substantially rigid material, the supporting segment having a supporting segment proximal end and a supporting segment distal end, an extending segment having a substantially tubular configuration including a flexible inverting portion comprised of a flexible material having a proximal end and a distal end, and an internal supporting member comprised of a substantially rigid material having a proximal end and a distal end. The internal supporting member proximal end is attached to the flexible inverting portion proximal end at an attachment area, wherein in an initial configuration, the flexible inverting portion is inverted such that the flexible inverting portion proximal end is distal to the flexible inverting portion distal end and the internal supporting member is distal to the flexible inverting portion, and wherein in a deployed configuration, the flexible inverting portion is un-inverted such that the flexible inverting portion proximal end is proximal to the flexible inverting portion distal end and the internal supporting member is positioned within the flexible inverting portion. The device further includes a bypass segment comprised of a flexible material having a substantially tubular configuration including a proximal end and a distal end, wherein the supporting segment, the inverting segment and the bypass segment are in fluid communication with one another, and wherein the supporting segment proximal end, the extending segment distal end and the bypass segment proximal end are connected at a connecting area. 
         [0012]    In accordance with additional embodiments of the present invention, there is provided a method for performing a minimally invasive bypass procedure. The method includes providing a device having a supporting segment, an extending segment, and a bypass segment in fluid communication with one another and wherein the extending segment is initially in an unextended configuration, making an incision in a vessel to be treated, inserting the supporting segment directly into the vessel through the incision and positioning the supporting segment in the vessel distal to the incision with the bypass segment positioned through the incision and out of the vessel, anchoring the supporting segment into the vessel, and extending the extending segment in a proximal direction such that the extending segment is positioned in the vessel proximal to the incision. 
         [0013]    In accordance with yet additional embodiments of the present invention, there is provided a delivery system for delivery of a graft to a vessel. The delivery system includes a guidewire having a proximal end and a distal end, wherein the proximal end is positionable outside of a body and wherein the distal end is configured to enter the body at an incision site, the distal end having a bent configuration. The guidewire further includes a proximal extension portion extending proximally from the distal end. The delivery system further includes an internal sheath having a first portion for enclosing a first segment of the graft and a second portion for enclosing at least a portion of the guidewire and extending proximally to a point outside of the body, wherein the proximal extension portion of the guidewire is partially enclosed by the first portion of the internal sheath and is removably attached to the first segment of the graft located within the internal sheath, the internal sheath movable with respect to the guidewire, a stopper attached to the proximal extension portion of the guidewire for holding the graft in place while the internal sheath is removed, and an external sheath for enclosing a second member of the graft and extending proximally to a point outside of the body, the external sheath movable with respect to the internal sheath and the guidewire. 
         [0014]    In accordance with yet additional embodiments of the present invention, there is provided a device for positioning in a vessel. The device includes a supporting segment configured to be placed directly through an incision in a vessel and to be anchored into the vessel in an area distal to the incision, an extending segment, wherein in a first configuration the extending segment is positioned within the supporting segment and in a second configuration the extending segment is extended proximally so as to be anchored into the vessel in an area proximal to the incision, and a bypass segment in fluid communication with the supporting segment and the extending segment, the bypass segment positioned through the incision and outside of the vessel. 
         [0015]    Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, suitable methods and materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0016]    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: 
           [0017]      FIG. 1  is a schematic illustration of a vessel having a bifurcation and a blockage in one of the branched vessels; 
           [0018]      FIGS. 2A-2D  are schematic illustrations of a device in accordance with embodiments of the present invention for treating a blocked vessel such as that depicted in  FIG. 1 ; 
           [0019]      FIG. 3A-3C  are schematic perspective illustrations of the device of  FIG. 2 , in accordance with embodiments of the present invention; 
           [0020]      FIG. 4A-4E  are illustrations of a delivery system for the device of  FIGS. 2 and 3 , in accordance with embodiments of the present invention; 
           [0021]      FIGS. 5A-5F  are cross-sectional illustrations of the device and delivery system of  FIGS. 2-4 , in various stages of deployment; and 
           [0022]      FIGS. 6A-6H  are illustrations of the various stages of deployment as described with reference to  FIGS. 5A-5F , shown in the vessel. 
       
    
    
       [0023]    It will be appreciated that for simplicity and clarity of illustration, elements shown in the drawings have not necessarily been drawn accurately 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, where considered appropriate, 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 
       [0024]    In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. It will be understood by those of ordinary skill in the art that the present invention may be practiced without these specific details. In other instances, well-known methods, procedures, components and structures may not have been described in detail so as not to obscure the present invention. 
         [0025]    The present invention is directed to a device, system, and methods for positioning of a bypass graft. The principles and operation of a device, system and methods according to the present invention may be better understood with reference to the drawings and accompanying descriptions. 
         [0026]    Before explaining at least one embodiment of the present invention in detail, it is to be understood that 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. 
         [0027]    It is appreciated that certain features of the invention, which 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, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination. 
         [0028]    For the purposes of the present application, the terms “distal” and “proximal” refer to the orientation of the device within the body of a patient. As used herein, “distal” refers to the end of the device extended into the body first, and “proximal” refers to the end of the device located farthest from the distal end of the device when the device is in its fully deployed configuration. The term “incision” refers to any opening of any size in the body. 
         [0029]    Reference is now made to  FIG. 1 , which is a schematic illustration of a vessel  200  having a bifurcation  202 . In one example, vessel  200  is a femoral artery, which branches off into a superficial femoral artery  210  and a deep femoral artery  212 . In other embodiments, vessel  200  may be another vessel in the body with branches. A blockage  204  is located in one of the branch vessels (in the present embodiment, the superficial femoral artery  210 ). Current methods for bypassing blockage  204  rely on surgical bypass methods, which may include autografts, xenografts or artificial grafts. It is a feature of the present invention to provide a minimally invasive method and system for delivery of a bypass device  208  into a vessel such as the femoral artery without the need for an open surgical procedure. 
         [0030]    Reference is now made to  FIGS. 2A-2D , which are schematic illustrations of a device  10  in accordance with embodiments of the present invention. The main operating principles of device  10  are depicted in  FIGS. 2A-2D , but the details of device  10  and systems and methods for its delivery into vessel  200  are described further hereinbelow. Device  10  includes a supporting segment  12 , an extending segment  14 , and a bypass segment  16 . Supporting segment  12 , extending segment  14  and bypass segment  16  are comprised of flexible graft material. In some embodiments, each of supporting segment  12 , extending segment  14  and bypass segment  16  is comprised of the same flexible material. In other embodiments, one or more of the segments are comprised of different flexible materials. Flexible materials may be any suitable flexible material such as, but not limited to, Dacron, PTFE, fluoro-based compounds, biological materials, etc. Supporting segment  12  has a supporting member  30  which provides support to the flexible material of supporting segment  12 . In some embodiments, supporting member  30  is an external supporting member and surrounds the flexible material. In other embodiments, supporting member  30  is an internal supporting member positioned internally with respect to the flexible material. In yet additional embodiments, supporting member is sandwiched between two layers of flexible material. Supporting member  30  is comprised of a substantially rigid material for support, such as a metal or a hard polymer, for example. Supporting member  30  may be a stent, for example. Similarly, extending segment  14  has a flexible inverting portion  15  and an internal supporting member  32 , wherein internal supporting member  32  is comprised of substantially rigid material. The material comprising internal supporting member  32  may be the same as or different than the material comprising supporting member  30 . In some embodiments, internal supporting member  32  further comprises an additional layer of flexible material therein, wherein said internal supporting member  32  surrounds the additional layer of flexible material so that blood flowing through extending segment  14  may be in contact with a flexible material rather than a substantially rigid material. 
         [0031]    Flexible inverting portion  15  has a proximal end  17  and a distal end  13 , and internal supporting member  32  has a proximal end  21  and a distal end  19 . Flexible inverting portion  15  is attached to supporting segment  12  at its distal end  13  at a connecting area  29 , and proximal end  21  of internal supporting member  32  is attached to proximal end  17  of flexible inverting portion  15  at an attachment area  34 . In the embodiment shown in  FIGS. 2A-2D , initially, extending segment  14  is in an inverted configuration, as shown in  FIG. 2A , with flexible inverting portion  15  proximal to extending segment proximal end  17 . 
         [0032]    As shown in  FIGS. 2B and 2C , when deploying extending segment  14 , only flexible inverting portion  15  is inverted, while internal supporting member  32  remains in its initial configuration. In this way, distal end  13  of flexible inverting portion  15  retains a distal position while proximal end  17  of flexible inverting portion  15  moves from a distal position to a proximal position. During these movements, internal supporting member  32  remains in its initial configuration, such that distal end  19  of internal supporting member  32  begins to align with distal end  13  of flexible inverting portion  15 , while proximal end  21  of internal supporting member  32  begins to align with proximal end  17  of flexible inverting portion  15 . Internal supporting member  32  sits within extending segment  14  and acts as a support for flexible inverting portion  15 . In this way, the substantially rigid members do not need to undergo deformation, un-inversion or other complicated configurations. In some embodiments, internal supporting member  32  is crimped onto a balloon, and in a final step, the balloon is expanded, thereby expanding internal supporting member  32 , as shown in  FIG. 2D . In other embodiments, internal supporting member  32  is enclosed within an outer sheath, which is then removed upon deployment of internal supporting member  32 . A bypass segment  16  remains positioned at an insertion site throughout the procedure, as will be described in greater detail. 
         [0033]    Reference is now made to  FIGS. 3A-3C , which are schematic perspective illustrations of device  10 , in accordance with embodiments of the present invention. Device  10  may be described as having three segments: a supporting segment  12 , an extending segment  14  and a bypass segment  16 , wherein supporting segment  12  and extending segment  14  are designed to be positioned within a vessel, and wherein bypass segment  16  is a synthetic bypass material which is attached to supporting segment  12  and extending segment  14  and which is designed to provide a bypass area for blood flow. An intersection of supporting segment  12 , extending segment  14  and bypass segment occurs at connecting area  29 . Supporting segment  12  has a supporting segment proximal end  18 , which is attached to connecting area  29 , and further includes a supporting segment distal end  20 , configured to enter the vessel first. Extending segment  14  has an extending segment proximal end  22 , which is the end of extending segment  14  furthest from supporting segment distal end  20 , and an extending segment distal end  24 , which is attached to connecting area  29 . Bypass segment  16  has a bypass segment proximal end  28  which is the end of bypass segment  16  which is furthest from supporting segment distal end  20 , and a bypass segment distal end  26 , which is adjacent to connecting area  29 . Supporting segment proximal end  18  and extending segment distal end  24  are positioned adjacent to bypass segment proximal end  26  at connecting area  29 . Supporting segment  12  includes a supporting member  30  and a flexible portion  31 , wherein in some embodiments, supporting member  30  is positioned external to flexible portion  31 , as depicted in  FIG. 3A , and in other embodiments, supporting member  30  is positioned internal to flexible portion  31 . In additional embodiments, as shown in  FIG. 3B , two layers of flexible portion  31  may be used, with supporting member  30  sandwiched in between the two layers, as depicted by dotted lines. Extending segment  14  includes a flexible inverting portion  15  and an internal supporting member  32 . In an initial configuration, extending segment  14  is inverted, or folded or rolled, into device  10  such that extending segment distal end  24  is proximal to extending segment proximal end  22 . After full deployment of device  10  within the vessel, the un-inverted configuration shown in  FIGS. 3A-3C  is obtained. In some embodiments, an internal surface of internal supporting member  30  may be covered with another layer of flexible material, as shown in  FIG. 3B . In some embodiments, supporting member  30  extends over connecting area  29 , and in additional embodiments may extend even further over a portion of bypass segment  16 , as shown in  FIG. 3C . 
         [0034]    Reference is now made to  FIG. 4A , which is an illustration of a delivery system  100  for device  10 , in accordance with one embodiment of the present invention. Delivery system  100  has a supporting segment sheath  102  surrounding supporting segment  12  and extending proximally to a delivery system proximal end  106 . Supporting segment sheath  102  may initially be positioned over the entire distal portion of device  10 , and may then be moved proximally so as to release supporting segment  12 . Supporting segment sheath  102  is depicted in  FIG. 4A  as being partially pulled back proximally, exposing an internal sheath  110 . Internal sheath  110  has an internal supporting member sheath portion  111  and a guidewire sheath portion  113 . Internal supporting member sheath portion  111  and guidewire sheath portion  113  are attached to one another at their respective distal ends at an attachment area  115  and are configured to separate from one another proximal to attachment area  115 . Means for rejoining internal supporting member sheath portion  111  and guidewire sheath portion  113  proximal to attachment area  115  after they have been separated from one another (i.e. after deployment of device  10 ) are described in greater detail with reference to  FIGS. 4B-4E . A guidewire  104  extends from proximal end  106  (proximal to the proximal end of supporting segment sheath  102 ) to a delivery system distal end  108  and is enclosed within guidewire sheath portion  113  of internal sheath  110 . At delivery system distal end  108 , guidewire  104  has a bent distal portion  112 , and further includes a proximal extension portion  114  which is attached to internal supporting member  32 , positioned within internal supporting member sheath portion  111  of internal sheath  110 . In some embodiments, bent distal portion  112  is external to internal sheath  110 . Internal supporting member sheath portion  111  of internal sheath  110  extends from an area proximal to bent distal portion  112  and covers internal supporting member  32 . Guidewire sheath portion  113  extends from an area proximal to bent distal portion proximally until proximal end  106  of delivery system  100 . Guidewire sheath portion  113  is moveable with respect to guidewire  104 . Since internal supporting member sheath portion  111  and guidewire sheath portion  113  are attached to one another, moving guidewire sheath portion  113  results in simultaneous movement of internal supporting member sheath portion  111 . 
         [0035]    Reference is now made to  FIGS. 4B-4E , which are illustrations of internal sheath  110 , showing internal supporting member sheath portion  111  and guidewire sheath portion  113  separated from one another proximal to attachment area  115 . This separation allows for deployment of device  10  within the vessel, as shown below with respect to  FIG. 5C . However, in order to retract internal sheath  110  after deployment of device  10 , it is necessary to rejoin internal supporting member sheath portion  111  and guidewire sheath portion  113  to enable both of these portions of internal sheath  110  to be retracted from the vessel together. Thus, a linking element  120  may be included for this purpose. 
         [0036]    In one embodiment, as shown in  FIG. 4B , linking element  120  includes a wire  122  extending from proximal end  106  of system  100  to distal end  108  of system  100  external to internal sheath  110 , with a wire loop portion  124  at distal end  108 . Wire loop portion  124  is configured to surround internal sheath  110 . By pulling wire  122  proximally, internal supporting member sheath portion  111  and guidewire sheath portion  113  are brought into contact with one another. Once they are in contact, wire  122  and internal sheath  110  may be pulled together proximally to remove them both from the vessel. 
         [0037]    In another embodiment, as shown in  FIG. 4C , linking element  120  includes a cable  126  having an internal portion  125  and an attachment portion  127 . Internal portion  125  is positioned through guidewire sheath portion  113  of internal sheath  110  and extends distally through guidewire sheath portion  113  until it reaches an opening  128 . Attachment portion  127  of cable  126  is a portion of cable  126  which extends through opening  128  and is attached to internal supporting member sheath portion  111 . Thus, by pulling proximally on cable  126 , internal supporting member sheath portion  111  is brought into contact with guidewire sheath portion  113 . Once they are in contact, cable  126  and internal sheath  110  may be pulled together proximally to remove them both from the vessel. Cable  126  may be of any suitable configuration, including a wire, a rope, a string, or any other relatively flexible material which is suitable for the method described herein. 
         [0038]    In another embodiment, as shown in  FIG. 4D , linking element  120  includes an attachment sheath  130 . Attachment sheath  130  is an additional sheath positioned external to internal sheath  110 , and includes a distal portion surrounding both internal supporting member sheath portion  111  and guidewire sheath portion  113 , and a proximal portion for guidewire sheath portion  113 . This configuration is similar to the wire with wire loop portion  124  as shown in  FIG. 4B , but instead of a wire, a sheath is used. An advantage of using a sheath is that the sheath can include a balloon  134  at a distal end thereof, with an inflation lumen  136  through attachment sheath  130 , as shown in  FIG. 4E . These types of balloons are known in the art and may be used to enhance apposition of device  10  to the inner wall of the vessel. 
         [0039]    Reference is now made to  FIGS. 5A-5F , which are cross-sectional illustrations of device  10  and delivery system  100  in various stages of deployment. As shown in  FIG. 5A , initially, flexible inverting portion  15  of extending segment  14  sits inside supporting segment  12 . Supporting segment  12  is shown in an expanded configuration, and includes a supporting member  30  surrounding supporting segment  12 . Supporting member  30  is shown herein as an external supporting member. It should be readily apparent that this configuration occurs only after removal of supporting segment sheath  102 . Internal supporting member  32  is held in an unexpanded configuration by internal supporting member sheath portion  111  of internal sheath  110 , which is positioned distal to supporting segment  12  and to flexible inverting portion  15 . Extension portion  114  of guidewire  104  is also positioned within internal supporting member sheath portion  111  of internal sheath  110 , and further includes a stopper  116  in the vicinity of distal end  112 . Stopper  116  is designed to hold internal supporting member  32  in place as internal sheath  110  is removed. Guidewire sheath portion  113  surrounds a portion of guidewire  104  which is proximal to bent distal portion  112  of guidewire  104 , and extends proximally through bypass segment  16  to a proximal end of delivery system  100 . Guidewire sheath portion  113  is attached to internal supporting member sheath portion  111  at attachment area  115 . Guidewire  104  also extends through bypass segment  16  within guidewire sheath portion  113  of internal sheath  110  to the proximal end of delivery system  100 . 
         [0040]    As shown in  FIG. 5B , guidewire  104  and guidewire sheath portion  113  of internal sheath  110  may be pulled proximally, causing internal supporting member sheath portion  111  of internal sheath  110 , extension portion  114  of guidewire  104 , stopper  116  and internal support member  32  to move proximally into supporting segment  12 . As shown in  FIG. 5C , this proximal motion continues until flexible inverting portion  15  is almost completely straightened out. During this proximal motion, guidewire sheath portion  113  and the portion of guidewire  104  which is within guidewire sheath portion  113  are configured to move proximally through bypass segment  16  while internal supporting member sheath portion  111  moves proximally within the vessel. This motion is made possible by the fact that these two portions are separatable proximal to attachment area  115  and it can occur until attachment area  115  reaches an intersection of bypass segment  16  and extended extending portion  14 . As shown in  FIG. 5D , guidewire  104  is then held in place, while internal sheath  110  is pushed distally to release internal supporting member  32 . Stopper  116  holds internal supporting member  32  in place while internal sheath  110  is pushed distally. Alternatively, internal supporting member  32  may be expanded with a balloon included on guidewire  104  or by any other method. Internal supporting member  32  may be comprised of a metal, polymer, or any other substantially rigid material which can provide support in a vessel. As shown in  FIG. 5E , guidewire  104  may then be pushed distally, internal supporting member sheath portion  111  and guidewire sheath portion  113  are brought together via linking element  120 , and then guidewire  104  and internal sheath  110  may be pulled together proximally through bypass segment  16 . Finally, as shown in  FIG. 5F , once delivery system  100  is removed via bypass segment  16  device  10  remains in place in the vessel. 
         [0041]    Reference is now made to  FIGS. 6A-6H , which are illustrations of the various stages of deployment as described with reference to  FIGS. 5A-5F , shown in the vessel  200 . As shown in  FIG. 6A , delivery system  100  with device  10  positioned therein is introduced into vessel  200  at an incision area  206 . Delivery system  100  is positioned upstream from bifurcation. As shown in  FIG. 6B , supporting segment sheath  102  is pulled back proximally, exposing bent distal end  112  of guidewire  104  and internal sheath  110 . As shown in  FIG. 6C , supporting segment sheath  102  is pulled further proximally, thus releasing supporting segment  12 . As shown in  FIG. 6D , supporting segment  12  with supporting member  30  anchors device  10  in place in within vessel  200 . As shown in  FIG. 6E , guidewire  104  and internal sheath  110  are pulled in a proximal direction, as shown by arrow  300 , and flexible inverting portion  15  begins to assume its uninverted configuration. Once flexible inverting portion  15  is in position, as shown in  FIG. 6F , internal supporting member  32  is expanded, as shown in  6 G, by holding guidewire  104  in place while pushing internal sheath  110  distally. Finally, as shown in  FIG. 6H , remaining portions of delivery system  100  are removed from vessel  200 , leaving device  10  in place, wherein supporting segment  12  and extending segment  14  are in vessel  200 , and wherein bypass segment  16  is external to vessel  200  for diverting blood flow away from the obstructed vessel while still allowing blood to flow through the unobstructed branch vessel. 
         [0042]    Extending segment  14  is not limited to the configuration described herein. For example, extending segment  14  may have a flap configuration wherein in a first configuration the flap is folded in and adjacent to supporting segment  12  and in a second configuration the flap is extended proximally into the vessel. Other configurations are possible as well and are included within the scope of the present invention. 
         [0043]    By using a system, device and method such as the ones described herein, it is possible to perform a percutaneous minimally invasive bypass procedure by directly accessing the vessel only through an incision in the vessel and anchoring the device therein, without the need for suturing or other complicated anastomoses. This procedure can serve as an alternative to surgical bypass, which is an extensive procedure requiring long hospital stays and associated with high risk. In some cases, when the surgery is considered extremely high risk, this may provide the only alternative for saving a limb.

Technology Category: 1