Abstract:
A support at the distal end of a bypass vein of either a synthetic material or of a saphenous vein for deployment inside an artery and the like to bypass a blockage in the artery, is described. The bypass vein is secured to a perimeter of the support with at least two protrusions extending from the support. The support and associate bypass vein are deployed inside the artery and then the support is pulled up against the artery wall by strings connected thereto to provide the bypass vein extending from the artery distal to the blockage. The other end of the bypass vein is then secured to artery proximate the occlusion to thereby establish blood flow.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This application is based on provisional applications Ser. Nos. 60/127,311, filed Apr. 1, 1999 and Ser. No. 60/153,218, filed Sep. 13, 1999. 
    
    
     BACKGROUND OF THE INVENTION 
     The present invention relates to a minimally invasive coronary bypass procedure which is the ideal operation for poor risk coronary artery patients. Existing techniques require either an extra-corporeal system or a time consuming anastomisis of the saphenosis vein to the coronary artery. In 1997, approximately 600,000 coronary artery bypasses were performed in the United States with a mortality rate of between 2% to 5%. While this mortality rate is relatively low, there is still room for improvement. 
     Accordingly, the present arterial procedure allows a surgeon to bypass an occluded coronary artery without an extra-corporeal system through a small chest incision and a graft insertion. The procedure provides a bypass vein, which is either a saphenous vein or of a synthetic material, having a first end sealingly secured to the occluded artery distal to the blockage by means of a novel barbed support. A second end of the bypass vein is secured to the occluded artery on the proximal side of the occlusion by means of a second one of the novel barbed support or by a stent to thereby establish unhindered blood flow. 
     SUMMARY OF THE INVENTION 
     The present arterial bypass procedure is performed under general anesthesia and routine preparation of the percutaneous approach. Through a limited left fifth intercostal space anteriorally, the chest is opened. Perocardium is incised and the coronary artery is identified. A needle is inserted into the designated coronary artery distal to the occlusion. This is followed by insertion of a guide wire and a peel-off sheath introducer. The bypass vein, mounted on a pusher device such as a coronary balloon, is then passed through the peel-off sheath. Under floroscopy guidance, the bypass vein is secured to the occluded artery distal to the occlusion while the peel-off sheath is removed. The opposite end of the bypass vein is then secured to the occluded vein proximal the occlusion, thereby bypassing the occlusion. The second end of the bypass vein is secured to the occluded vein by either a stent or a barbed support of the present invention. 
    
    
     These and other aspects of the present invention will become increasingly more apparent to those skilled in the art by reference to the following description and to the appended drawings. 
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a perspective view of a support ring  22  and bypass vein  24  according to the present invention being moved through a sheath conduit  16  puncturing an occluded artery  10 . 
     FIG. 2 is a perspective view of the support ring  22  and bypass vein  24  partially deployed out the distal open end  20  of the sheath conduit  16 . 
     FIG. 3 is a perspective view of the support ring  22  and bypass vein  24  just before the support ring is moved into position to seal against the inside of the artery  10 . 
     FIG. 4 is an enlarged, perspective view of the support ring  22  and bypass vein  24  secured to the occluded artery  10 . 
     FIGS. 5 and 6 are perspective views of an alternate embodiment of the present invention including a bypass vein  50  secured to a coil spring  52 . 
     FIG. 7 is a perspective view of an alternate embodiment of the present invention including a bypass vein  60  secured to a V-shaped member  62 . 
     FIG. 8 is a perspective view showing two bypass veins according to the present invention use to bypass an occluded artery. 
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Referring now to the drawings, FIG. 1 shows an artery  10  proximate a muscle  12 , such as a cardiac muscle and the like. An occlusion  14  blocks free and open blood flow through the artery  10 . 
     According to the present invention, a sheath conduit  16  is moved through the muscle  12  and along a guide wire (not shown) previously positioned into the artery. The sheath conduit  16  extends through an opening  18  in the artery on one side of the occlusion  14  to position its distal end  20  inside the artery  10 . The sheath conduit  16  is of a metallic material that is compatible with the physiology of the host body and is readily detectable by conventional imaging means. In that manner, the precise position of the sheath conduit  16  is determined by imaging its location until it is properly positioned in the artery  10 . 
     The sheath conduit  16  serves as a lumen for placement of a ring support  22  (FIG. 4) and associated bypass vein  24  inside the artery  10 . The support ring  22  is a self-expanding wire loop, such as a Nitinol wire, which provides an enclosing support. In a broader sense, however, the support can have a myriad of shapes including a coil spring shape (FIGS. 5 and 6) and a V-shape (FIG.  7 ). These alternate shapes will be described in detail hereinafter. 
     The ring  22  supports the bypass vein  24 , which is a saphenous vein or of a synthetic, microporous material providing a lumen or conduit secured to the perimeter of the ring. In a preferred embodiment of the present invention, the support ring  22  is readily foldable into a shape that is movable through the sheath conduit, and the bypass vein  24  is of a polyurethane material sewn  26  or otherwise secured to the perimeter thereof. 
     In another embodiment of the present invention, the sheath conduit  16  serves to expand the opening  18  in the artery  10  to a size sufficient to have the sheath conduit  16  provided with a lumen that enables the support ring  22  to move there through in an unfolded condition. At such time as the sheath conduit  16  is removed from the artery  10 , the opening  18  closes somewhat to a size that is smaller than the perimeter of the support ring  22 . This is especially the case if the support ring  22  is moved through the sheath conduit  16  in an unfolded condition. If the support ring  22  is deployed in a folded condition and subsequently unfolded once it has left the sheath conduit  16 , rebound of the artery tissue surrounding the opening is not as critical. In any event, the support ring  22  must be larger than the opening  18  in the artery  10  with the needle removed. 
     The support ring  22  is provided with a plurality of protrusions or barbs  28  spaced about the perimeter thereof. The barbs  28  are in the form of staples or wire-like projections. As shown in FIG. 2, just prior to closing the opening  18  in the artery  10  the barbs  28  point toward the inner side  30  of the artery. With this construction, the barbs  28  do not extend outwardly beyond the radial perimeter of the support ring  22 , nor do they extend inwardly to interfere with an enclosed projection of the area bounded by the support ring  22 . 
     The support ring  22  is further provided with a pair of spaced apart strings  32  and  34  connected to opposed portions of the ring. The strings are preferably of a degradable material that is safe to the host body. In an alternative embodiment, the strings are connected to spaced apart ones of the barbs  28 . The string can extend through the conduit of the bypass vein or they can extend outside the bypass vein, and there can be more than two strings. For example, there could be four strings, one tied to each quadrant of the support ring. In a preferred embodiment of the present invention, the strings  32 ,  34  are coded, such as by color, to indicate the relative postion of the support ring  22  and its barbs  28  inside the artery  10  and, later, when the bypass vein  24  is secured to the artery. In still a further embodiment, there is only one string that bifurcates proximate the support ring  22  to connect to spaced apart portions of the support or to spaced apart barbs. 
     As shown in FIG. 1, to secure the bypass vein  24  to the artery, the support ring  22  connected to the strings  32 ,  34  is moved through the sheath conduit  16  and out a distal open end thereof by a push device  36 . Accordingly, after the bypass vein  24  is deployed out the distal open end  20  of the sheath conduit  16  (FIG.  2 ), the conduit is removed from the artery  10  (FIG. 3) and the strings  32 ,  34  are pulled to move the bypass vein  24  including the support ring  22  up against the inner side  30  of the artery  10 . The strings  32 ,  34  are further pulled to cause the barbs  28  to pierce the artery  10  surrounding the puncture with the barbs anchoring the support ring  22  in place. Accordingly, the support ring  22  is circular or oval and is of a size sufficient to surround the puncture. The support ring, being flexible, also readily conforms to the non-planar shape of the artery to effectively seal against the inner side  30  of the artery surrounding the opening  18  (FIG.  4 ). 
     While it is within the scope of the present invention to secure the strings  32 ,  34  to opposed portions of the support ring  22  or to diametrically opposed protrusions  26 , it is most preferred to secure the strings to the support ring. That way, the strings do not interfere with movement of the protrusions through the arterial wall. After the bypass vein  24  is in place, the strings are then temporarily secured to the skin for future removal. 
     Finally, the proximal end (not shown) of the synthetic vein  24  is sutured or stented to a second opening (not shown) in the artery  10  proximal the occlusion  14 . Once both ends of the bypass vein  24  are secured, circulation to the ischemic portion of the myocardium is established. The arterotomy incision is then closed. 
     An alternate embodiment of the present invention is shown in FIGS. 5 and 6. This embodiment comprises a bypass vein  50  secure to a coil spring  52 . The bypass vein  50  is secured to the spring  52  at a central location by stitches  54  and the like, and the spring is deployed through the sheath conduit in a relatively tightly coiled condition (FIG.  5 ). Once the coil spring/bypass vein assembly is moved out through the distal open end of the sheath conduit, the spring uncoils (FIG. 6) to a size sufficient to seat against the artery side wall. While not shown, the coil spring is provided with barbs in a similar manner as the previously described support ring  22  to anchor the spring in the artery side wall. 
     Another embodiment of the present invention is shown in FIG. 7 comprising a bypass vein  60  secured to a V-shaped member  62  by stitches  64  and the like. The V-shaped member  62  is readily folded up to provide for moving it and the bypass vein  60  through the sheath conduit to deploy the assembly in the occluded artery. Once the V-shaped member has moved out the distal open end of the sheath conduit, the V-shaped member expands to its unfolded size and the barbs  66  are anchored to the artery side wall, as previously described, to connect the bypass vein  60  to the occluded artery. 
     Also, it is contemplated by the scope of the present invention that there can be one of the present invention support structures at each end of the bypass vein to provide the arterial by-pass. In that case, there would actually be two bypass veins secured to the occluded artery on opposite sides of the occlusion  14  (FIG.  8 ). After the two bypass veins are deployed and secured to openings in the artery on the distal and proximal sides of the occlusion  14 , their respective opposite ends are then sewn or secured together to complete the bypass procedure. In the alternative, there could be one bypass vein having the novel barbed ring support of the present invention at both of its ends. To secure the second barbed ring support, the strings are provided on the outside of the bypass vein so that they can be removed. 
     While the present invention has been described with respect to a coronary bypass procedure, it should not be so limited. Those skilled in the art will readily recognize that the present procedure can be used to short circuit or bypass any occluded artery, no matter where it exists, such as an occluded artery in the legs. Further, a surgical procedure with more than one vein bypass according to the present invention is contemplated. 
     It is appreciated that various modifications to the inventive concepts described herein may be apparent to those of ordinary skill in the art without departing from the spirit and scope of the present invention as defined by the herein appended claims.