MXPA99007689A - Bifurcated vascular graft and method and apparatus for deploying same - Google Patents

Abstract

A structurally supported bifurcated vascular graft (30) is described having a hollow cylindrical body graft (32) with a top end (38), a bottom end (40), and two hollow cylindrical limb grafts (34, 36) which are attached to the hollow cylindrical body graft near the top end of the body graft. One or more structural supports or stents (42) are attached to either the interior or exterior of the body graft and limb grafts. Further, an apparatus and method for delivering a one-piece bifurcated vascular graft is also described which includes first and second hollow limb tubes for containing the limbs of a bifurcated graft, and a hollow delivery tube capable of encompassing the limb tubes and graft body.

Description

DEVICE FOR DEPLOYMENT OF VASCULAR BIFURCED GRAFT Field of the Invention The present invention relates generally to a bifurcated graft and to a method and apparatus for delivering the same within the body of a patient using a minimally invasive method. More particularly, the present invention includes a bifurcated vascular graft having two grafts of hollow cylindrical members of an identical first diameter fixed therebetween along a portion of their circumferences at their first ends and a third hollow cylindrical body graft of a larger diameter circumferentially positioned on the first two hollow cylindrical grafts such that the remaining unconnected end circumferences of the first two hollow cylindrical grafts are connected around an end circumference of the third hollow cylindrical body graft bisecting the diameter of the third hollow cylindrical body graft in half. The present invention also includes a method Rf341154 and an apparatus for supplying the grafted vascular graft of the present invention which includes the first and second tubes of hollow members of approximately equal diameter and of varying lengths to contain the two grafts of limbs. hollow cylindrical, a third hollow cylindrical body tube having a larger diameter than the first and second tubes of hollow members to contain the hollow cylindrical body graft, a metal tube to contain a guide wire, and a tube of hollow supply which is able to cover the first and second tubes of hollow members, the tube of the hollow body, and the metal tube.

Background of the Invention Endoluminal repair or exclusion of aortic aneurysms has been performed for several years in the past. The goal of the exclusion of the endoluminal aortic aneurysm has been to correct this life-threatening disease in a minimally invasive way to carry out a rapid and complete recovery of the patient. There are several vascular grafts in the prior art which have been used to exclude aortic aneurysms. These prior art grafts have enjoyed varying degrees of success. Initially, straight tube grafts were used in the abdominal aorta to exclude the aneurysmal sac from the bloodstream resulting in a weakened aortic wall that is protected by the graft material. These straight tube grafts were initially unsupported, which means that they used small disposable tubes (stents) at their proximal and far ends to anchor the proximal and far ends of the graft to the healthy portions of the aorta so they leave a intermediate section of the graft or prosthesis that does not have any internal support or with small disposable tubes. Although this type of graft initially seemed to correct the aortic aneurysm, it suffered from many faults. The unsupported nature of its midsection allowed the graft to migrate at a certain distance as well as exhibited a significant proximal leak due to enlargement of the aorta without graft adaptation, such as graft enlargement, to accommodate the change in diameter of the graft. the aorta. Later, the technical improvements in the design of the small disposable tube led to small "self-expanding" disposable tubes. In addition, the latest improvements produced the small disposable "nitinol" tubes which have a "memory" that was able to expand to a predetermined size. Coincidentally, graft designers begin to develop bifurcated grafts that have limbs that extend into the iliac arteries. The development of bifurcated grafts allowed the treatment of more complex aneurysms. With the emergence of bifurcated grafts, the need for at least one centimeter neck from the aspect or dimension remote from the aneurysmal sac to the iliac bifurcation to treat the aneurysm with an endoluminal graftIt was not necessary anymore. However, necks close to at least 0.5 to 1 centimeter away from the renal arteries to the nearest aspect or dimension of the aneurysm are still required. Many bifurcated grafts are of a two-piece design. These two-piece designs require the insertion of a contralateral limb through a separate access site. These types of grafts are complex in their deployment and have a potential for leakage at the connection site of the two graft members. The one-piece bifurcated grafts have also been designed. However, its deployment is still somewhat complicated and has torsional tendencies.

One piece bifurcated grafts are well known in the art. For example, U.S. No. 2,845,959 discloses a bifurcated textile tube woven seamlessly in one piece for use as an artificial artery. Yarns of variable materials can be used to corrugate the bifurcated fabric including plastic and nylon threads. The U.S. Patents Nos. 3,096,560 and 3,029,819 issued to Leibig and Star s, respectively, describe one-piece bifurcated, woven grafts, which are constructed by running specific types of twisting and braiding around a smooth bifurcated mandrel. The U.S. Patent No. 4,497,074 discloses a one-piece bifurcated graft which is made of a preformed support in the form of the bifurcated (i.e. molded) graft. In a first stage, a gel that makes possible a superficial state close to that of the liquid-air interface that is going to be obtained in the gel-air interface, is deposited by submerging or coating the preform with a sol which is allowed let it cool A hardenable flexible material such as a silicone elastomer is deposited by submerging or spraying the material onto the mold in a second step. Finally, after hardening the material, the prosthesis is removed from the mold. In U.S. Pat. Do not.

No. 4,816,028 issued to Kepadia et al., Shows a one-piece bifurcated non-woven vascular graft having a plurality of warp yarns running in the axial direction and a plurality of weft threads running in the transverse direction. In addition, U.S. Pat. No. 5,108,424 issued to Hoffman, Jr. et al., Describes a dacron graft impregnated with collagen, bifurcated, in one piece. The bifurcated graft includes a porous synthetic vascular graft substrate formed by knitting or braiding with at least three applications of the dispersed collagen fibrils. The U.S. patent No. 5,197,976 to Herck et al., Discloses a continuous, one-piece, bifurcated graft having longitudinally parallel, plural tube structures which are fixed to each other on at least a portion of their longitudinal exteriors. The tubular structures can be manually separated to form an anchored tubular structure. The prosthesis is manufactured by the formation of a paste and the stretching and / or expansion of polytetrafluoroethylene (PTFE), non-sintered, highly crystalline. The formation of the paste includes mixing the PTFE resin with a lubricant, such as a mineral alcoholic beverage, and then forming the resin by extrusion into shaped articles.

Although all of the one-piece bifurcated grafts described above have eliminated the problems of leakage and the failure of the graft at the junction site or suture associated with two-piece bifurcated grafts which join together two separate grafts to form the bifurcated graft , there are still problems with these one-piece bifurcated grafts. For example, the one-piece bifurcated grafts described previously do not include an integral support structure to prevent deformation, twisting or crushing of the graft members. In addition, the same problems that existed with graft migration with straight tubular grafts still exist with bifurcated one-piece grafts. Accordingly, there is a need for a stable and durable bifurcated graft which is structured to prevent graft migration and deformation and obstruction of blood flow through the bifurcated graft members. Endoluminal implantation is a common technique for implanting vascular grafts.

Typically, this procedure involves percutaneously inserting a vascular graft or prosthesis using • a supply catheter. This process eliminates the need for major surgical intervention, thereby decreasing the risks associated with vascular and arterial surgery. Various catheter delivery systems for prosthetic devices are described in the prior art. For example, bifurcated vascular grafts have been created by combining the grafts with small disposable tubes on the delivery systems to secure the ends of the graft to the blood vessel, whereby the bifurcated graft is stabilized. In U.S. Pat. No. 5,360,443 issued to Barone et al., Describes a method for repairing an abdominal aortic aneurysm. The method comprises the steps of 1) connecting an expandable and deformable tubular member, such as a small disposable tube, to each of the tubular passages of a bifurcated graft, 2) placing the bifurcated graft and the deformable tubular members within the arteries aortic and iliac, and 3) expand and deform each tubular deformable element with a catheter to secure each tubular passageway of the bifurcated graft within the appropriate artery. This reference only describes a method of delivery of the catheter to deploy the aortic portion of the bifurcated graft. The same catheter is also supposedly used to expand and secure the associated small disposable tubes within the iliac arteries. The U.S. patent No. 5,316,023 to Palmaz et al. Discloses a method and apparatus for repairing an abdominal aortic aneurysm in an aorta having two iliac arteries. This method includes the steps of connecting a first tubular graft to a first deformable and expandable tubular member, connecting a second tubular graft to a second deformable and expandable tubular member, placing the first tubular graft and the first tubular member on a first catheter that has an inflatable portion, placing the second tubular graft and the second tubular member on a second catheter having an inflatable portion, intralutally supplying the first and second tubular grafts, the tubular members and the catheters to the aorta and placing at least one portion of each tubular graft within the abdominal aortic aneurysm, and expanding the tubular elements with the inflatable catheters to secure them and at least a portion of their associated tubular grafts within the aorta. This patent reference employs two separate, unconnected, straight grafts which are employed within the aorta to form a bifurcated graft. In addition, U.S. Pat. No. 4,617,932 issued to Kornberg discloses a device for inserting a graft into an artery comprising a plurality of plug-in or telescopic tubes each having an upper and lower end. A first outer tube has a means to guide and place an arm means at its upper end. The arm means is movably secured to the upper end of the other tube located within the first tube and which extends above the first outer tube. The lower ends of the tubes are adaptable to secure the means and the inner tube extends below the end of the first outer tube. The supply and placement of a bifurcated graft is illustrated. The U.S. Patent No. 5,522,883 issued to Slater et al., Discloses a small graft / disposable stent delivery system, which includes a tubular delivery catheter, an expandable prosthesis radially positioned over the catheter, a localized removable stent mounting assembly adjacent to the catheter opening and having an arm extending through the catheter which holds the stent in a compressed state, and a release mechanism insertable through the catheter to remove the support assembly. The U.S. Patent No. 5,104,389 issued to Lazarus also describes an artificial graft and a delivery method. The delivery system includes a capsule for transporting the graft through the blood vessel, a tube connected to the vessel which extends outwardly with respect to the vessel for manipulation by a user, and a ball catheter positioned within the tube. Finally, U.S. Pat. No. 5,489,295 issued to Piplani et al., Describes a bifurcated graft and a method and apparatus for deploying the bifurcated graft. The graft of Piplani et al. Includes a main tubular body, first and second legs attached to the main tubular body at a bifurcation, a first expandable fixation means for anchoring the main body located adjacent to the opening for the first body, and a second expandable fixation means located adjacent to the opening of the first tubular leg for anchoring the first tubular leg. The graft is implanted intraluminally using a catheter that is inserted into the aortic bifurcation through a first iliac artery so that the first fixation means adjacent to the opening of the main body can be anchored in the aorta and the second adjacent fixation means The opening of the first tubular leg can be anchored in the first iliac artery. The second tubular leg is deployed to the second iliac artery using a pull line attached to the second tubular leg. The Piplani et al. Patent also describes a deployment device consisting of a capsule catheter, a ball catheter, and a separate expandable spring fastening means. The previously described methods, systems and deployment devices do not allow a bifurcated graft which is fully supported with the small self-expanding disposable tubes that are to be delivered and implanted within an arterial bifurcation. A use of any of the deployment devices or systems previously described for implanting the structurally supported bifurcated graft of the present invention, could lead to failure due to the inability of these devices and systems to supply and anchor the second supported member within the second iliac artery. The methods and systems previously described simply do not allow the delivery and implantation of a bifurcated vascular graft whose three open ends are supported by small disposable tubes. Accordingly, not only is there a need for a stable and durable bifurcated structurally supported graft which is not susceptible to migration and leakage, but there is also a need for a delivery method and apparatus for deploying and implanting such a bifurcated graft.

Brief Description of the Invention It is a principal object of the present invention to provide a bifurcated vascular graft and a method and apparatus for deploying the bifurcated vascular graft. It is another object of the present invention to provide a bifurcated vascular graft having structurally supported, partial members, which will not deform, twist, or crush, whereby obstruction of blood flow through the members of the bifurcated vascular graft is prevented. . It is still another object of the present invention to provide a bifurcated vascular graft having a structurally supported main graft body, which provides support to an unsupported portion of the bifurcated vascular graft members to prevent migration of the bifurcated vascular graft. It is still another object of the present invention to provide a physically stable, structurally supported bifurcated vascular graft, which will occlude small blood vessels from hemorrhages in the area of the bifurcated vascular graft. It is still another object of the present invention to provide a bifurcated vascular graft having spaced member channels whereby partial deployment of the bifurcated graft is allowed. The advantage of this design can be observed when a graft member fails to deploy due to anatomical or structural problems. In this case, the successfully deployed graft members will be able to direct blood to the occluded member by means of a femoral-femoral bypass. Most of the current bifurcated graft designs are not recoverable in this way and their failure to deploy usually forces a conversion to classical surgery. It is still another object of the present invention to provide a method and apparatus for deploying any bifurcated one-piece graft, including the bifurcated vascular graft of the present invention, into the body of a patient. It is still another object of the present invention to provide a method and apparatus for intraluminally deploying a bifurcated, one-piece graft, including the bifurcated vascular graft of the present invention, within the body of a patient, which is simple and efficient. Still another object of the present invention is to provide a method and apparatus for repairing an aortic aneurysm which is non-invasive and which does not require suturing the graft to the aortic wall or the iliac arteries. In summary, the bifurcated vascular graft of the present invention includes: a hollow tubular body member having first and second open ends; a first hollow tubular member having first and second open ends, and a second hollow tubular member having first and second open ends wherein the first open end of each of the first and second elements of the hollow tubular member are connected to the hollow tubular body element near the first open end of the hollow tubular body member such that a length of the member elements is circumferentially contained within the hollow tubular body member.The grafted vascular graft includes small disposable tubes or similar support structures which are placed adjacent to the three openings contained in the bifurcated vascular graft A small disposable tube may be placed in such a way that it encompasses the entire inner surface of the hollow tubular body member while two additional small disposable tubes They can be placed around the s outer surface close to the second ends of the first and second hollow tubular member members, respectively. Cuffs can also be formed at the ends of these member elements to fold the second ends of the grafts back onto the small disposable tubes. A method for manufacturing the bifurcated vascular graft of the present invention includes the steps of: a) cutting approximately half a circumference of a thin hollow tube until approximately 3/4 of the circumference is cut off; b) folding or folding the hollow thin tube in a cut from the uncut portion to form two hollow tubular member elements having equal diameters which are fixed to each other along a fold or bend; c) placing the hollow tubular member elements within a hollow tubular body member having a diameter of at least twice the diameter of the hollow tubular member members; and d) fixing the cut ends of the hollow tubular member elements to one end of the tubular body member such that a length of the member elements is circumferentially contained within the hollow tubular body member. The method may also include the steps of placing a first structural support adjacent the end of the hollow tubular member containing the attachment of the cut ends of the two hollow tubular elements wherein the first structural support is located around the interior of the hollow tubular member, and placing second and third structural supports around the outside of the hollow tubular member elements, respectively, at the ends of the two elements of the hollow tubular member that are opposite the fold or fold. In another aspect of the present invention, the preferred apparatus for deploying a bifurcated vascular graft within the body of a patient includes: a first tube of the member for loading the first member; a second tube of the member for loading the second member, wherein the first and second tubes of the loaded member are placed parallel to each other; a graft body tube for loading the body of the main graft, wherein the graft body tube is positioned adjacent the parallel ends of the first and second tubes of the member; and an outermost tube for charging the first and second tubes of the limb and the tube of the graft body in such a way that all of the tubes are contained within the outermost tube. Another embodiment of the deployment apparatus includes first and second member tube elements which can both be inserted into the body tube of the graft at the same time. The deployment apparatus may also include a metal tube and a guide wire which are insertable throughout the entire length of the apparatus. The first and second tubes of the member have approximately equal diameters and the second tube of the member is preferably shorter than the first tube of the member. Finally, the method of the present invention for intraluminally supplying a bifurcated vascular graft having a main graft body which bifurcates into first and second members within the patient's body, includes the steps of a) loading the first and second members and the body of the main graft in separate tubes, b) inserting the tubes endoluminally into the patient, c) placing the tubes inside the patient, and d) deploying the limbs and the graft of the main body one at a time by removing their respective tubes. An example in which this simple and non-invasive method can be used is in the repair of an abdominal aortic aneurysm. The objects, features and additional advantages of the variable aspects of the present invention will become more apparent from the following description in which the preferred embodiments of the present invention are described in detail in conjunction with the appended drawings.

Brief Description of the Drawings In the drawings, which illustrate the best mode currently contemplated for carrying out the invention, Figure 1 is an exploded perspective view of the deployment apparatus of the present invention, Figure 2 is a perspective view of the bifurcated vascular graft, structurally supported, of the present invention, with small structural disposable tube supports located on the inside of the graft shown with dotted lines. The portions of the hollow tubular member elements of the bifurcated vascular graft are also shown with dotted lines. Figure 3 is a view of the right extremity of the structurally supported bifurcated vascular graft of the present invention, which is taken from the proximal end of the bifurcated vascular graft, which includes the main tubular body of the graft. Figure 4 is a cross-sectional view taken along line 4-4 of Figure 3. Figure 5 is a partial cross-sectional view of the deployment apparatus of the present invention with the structurally supported bifurcated vascular graft of the present invention, shown loaded within the deployment apparatus of the present invention prior to deployment of the structurally supported bifurcated vascular graft. Figure 6A is a perspective view of a second hollow member tube of the deployment apparatus of the present invention which retains the second hollow tubular member element of the bifurcated vascular graft of the present invention during placement, and prior to deployment, in the bifurcated vascular graft of the present invention.

Figure 6B is a partial perspective view of a bifurcated blood vessel with the blood vessel shown cut away to illustrate the location and placement of the deployment apparatus of the present invention which contains the structurally supported bifurcated vascular graft of the present invention. The outermost portions of the deployment apparatus are also shown cut away to illustrate the position of the first and second tubes of the limb and the tube of the graft body which comprises the deployment apparatus. A portion of the second member tube is shown with dotted lines. Figures 7A-7F are diagrams showing the method and apparatus of the present invention used to deploy the structurally supported bifurcated vascular graft of the present invention. Figure 7G is a partial perspective view of a bifurcated blood vessel shown cut away to illustrate the structurally supported bifurcated vascular graft of the present invention, deployed and anchored in place within the bifurcated blood vessel.

Description of the Preferred Modalities An exploded perspective view of the deployment apparatus 20 of the present invention is shown in Figure 1. The deployment apparatus 20 includes a tube 21 of the graft body, variable in length and diameter having a tapered tip 22, a first tube of the member 23 of variable length and diameter which is connected to the hemostatic valve 24, a second tube of the member 25 of variable length and diameter having a tapered tip 26 and a guide wire 27 coming from the tapered tip, a further tube outer diameter 28 of variable length end which is large enough to contain the tube 21 of the graft body and the first and second tubes 23 and 25 of the member at the same time and a hemostatic valve 31 connected to the outermost tube 28, and a small metallic guide tube 29, of variable length and diameter, which is large enough to allow a guide wire to pass therethrough. The metal guide tube 29 is fixed to the tube 21 of the graft body within the tube 21 of the graft body, near its tapered end 22 when the device is fully loaded and ready to deploy. A Luer fixation 12 is shown connected to the metallic guide wire 29 and a three-way stopcock for adding and removing fluid is shown connected to the hemostatic valve 24 for the first tube 23 of the member. It should be noted that the deployment apparatus 20 of the present invention can be used to deploy any bifurcated graft in one piece, not only the bifurcated vascular graft 30 of the present invention. Figure 2 shows a perspective view of the bifurcated vascular graft 30 of the present invention. Bifurcated vascular graft 30 comprises a hollow tubular body member 32, a first hollow tubular member member 34, and a second hollow tubular member member 36. The element 32 of the hollow tubular member has a first open end 38 and a second open end 40. A first small disposable tube 42 is placed around the interior of the hollow tubular body member 32 to support the hollow tubular graft body member 32. The first small disposable tube 42, or any other suitable biocompatible structural support, preferably encompasses the entire interior surface area of the element 32 of the hollow tubular body to provide the necessary structural support. In addition, the element 32 of the hollow tubular body can be fully supported by securing several small disposable tubes along the entire length of the element 32 of the hollow tubular body. The first and second elements 34 and 36 of the hollow tubular member have approximately the same diameter, each of which is smaller than the diameter of the element 32 of the hollow tubular body. The first element 34 of the hollow tubular member comprises a first open end (not shown) and a second open end 44. Similarly, the second element 36 of the hollow tubular member comprises a first open end (not shown) and a second open end 46. The second and third small disposable tubes 48 and 50, respectively, are positioned adjacent the second ends 44 and 46 of the first and second elements 34 and 36 of the hollow member such that they each cover an outer portion of the hollow member. its members 34 and 36 of the member. The second and third small disposable tubes 48 and 50 only encompass that portion of their elements 34 and 36 of the respective member which extends from the second end 40 of the element 32 of the hollow tubular body. Alternatively, the second and third small disposable tubes 48 and 50 may encompass the first and second elements 34 and 36 of the complete hollow tubular member, extending along their entire lengths. In addition, as previously explained with reference to the first small disposable tube 42, the second and third small disposable tubes 48 and 50 may each comprise a plurality of small disposable tubes or structural supports. Also, these small disposable tubes can support the first and second elements 34 and 36 of the hollow tubular member either externally or internally. The first and second elements 34 and 36 of the hollow tubular member are contained circumferentially within the element 32 of the hollow tubular body such that a portion of the elements 34 and 36 of the hollow tubular member traverses the length of the element 32 of the hollow tubular body. As previously explained, the support structure used to provide the structural support external to those portions of the hollow tubular members 34 and 36 which extend beyond the second end 40 of the element 32 of the hollow tubular body, may comprise one or more of small self-expanding disposable tubes of varying lengths or any other suitable biocompatible structural support that will self-expand to a diameter of the surrounding vessel. The second and third small disposable tubes 48 and 50 are attached and anchored to the first small disposable tube 42 to form the joint 49 and 51. This configuration prevents twisting and / or misalignment of the members 34 and 36 of the graft 30. When loading the bifurcated vascular graft 30 onto the deployment apparatus 20 of the present invention, the first element 34 of the hollow tubular member is loaded into the first tube 23 of the member, the second element 36 of the hollow tubular member is loaded into the second tube 25 of the member, and the element 32 of the hollow tubular body is loaded into the tube 21 of the graft body. In a preferred embodiment, the first and second tubes 23 and 25 of the member, loaded, can be dimensioned in such a way that they will be supported end to end with the tube 21 of the graft body loaded. Alternatively, the first and second tubes 23 and 25 of the member, loaded, can be of a sufficiently small diameter such that they can be inserted inside the tube 21 of the body of the graft so that they can contain the complete length of the first and second elements 34 and 36 of the respective hollow tubular member, inside the tube 21 of the graft body. The tube 21 of the loaded graft body and the first and second tubes 23 and 25 of the loaded member are then fully loaded into the outermost tube 2B which is connected to a hemostatic valve 31. The metallic tube 29 containing a wire guide (not shown), separate and distinct from the guide wire 26 connected to the second tube 25 of the member, can be inserted through the complete loaded apparatus. Turning now to Figure 3, a view of the right extremity of the structurally supported bifurcated vascular graft 30 of the present invention is shown with the view of the right extremity taken from the proximal end of the bifurcated vascular graft. As can be seen from Figure 3, the first and second elements 34 and 36 of the hollow tubular member are connected together along a diameter of the element 32 of the hollow tubular body which divides the lumen or cavity of the body element 32 Tubular hollow in half. The first and second elements 34 and 36 of the hollow tubular member include first and second lumens or cavities, 52 and 54, respectively, which are approximately equal to each other with respect to the area and which are fitted within the lumen of the body element 32 tubular hollow. The first open ends 56 and 58 of the elements 34 and 36 of the hollow tubular member, respectively, can be observed from this view of the right extremity of the bifurcated vascular graft 30. These portions of the circumference of the first open ends 56 and 58 of the first and second hollow tubular members 34 and 36 which are not fixed to each other, are connected to the circumference of the first open end 38 of the element 32 of the hollow tubular body. The first small disposable tube 42 is located around the inner surface area of the element 32 of the hollow tubular body and is therefore contained between the interior of the hollow body member 32 and the exteriors of the first and second hollow tubular members 34 and 36 This portion of the circumference of the first ends 46 and 58 of the first and second hollow tubular members 34 and 36 which are fixed to each other, may be supported by a transverse support seam or support suture 60 which is placed below of the fixed area and inside the interior of the element 32 of the hollow tubular body. Another seam or suture 57 is positioned through the diameter of the second end 40 of the element 32 of the hollow tubular body such that the ends 59 and 61 of the suture are left to be left behind from the second end 40 of the body member 32. to assist in the deployment of the bifurcated vascular graft 30. A cross-sectional view of the bifurcated vascular graft 30 of the present invention, taken along line 4-4 of Figure 2 is shown in Figure 3. The first ends 56 and 58 of the first and second hollow tubular members 34 and 36 are fixed to the first end 38 of the element 32 of the hollow tubular body such that the first and second hollow tubular members 34 and 36 are partially contained within the lumen of the element 32 of the hollow tubular body. The first small disposable tube 42 (or structural support) is placed around the inner surface of the lumen of the hollow tubular body member 32 and is therefore contained between the inner surface of the hollow tubular body member 32 and the outer surfaces 62 and 64 of the first and second elements 34 and 36 of the hollow tubular member, respectively. The second and third small disposable tubes 48 and 50 (or structural supports) are positioned adjacent the second ends 44 and 46 of the first and second elements 34 and 36 of the hollow tubular member, respectively, such that they encompass a portion of the outer surfaces 62 and 64 of the first and second elements 34 and 36 of the hollow tubular member, respectively. Also, as previously described, the first and second elements 34 and 36 of the hollow tubular member may be structurally supported with small disposable tubes along their entire length.

Figure 5 shows a partial cross-section of the deployment apparatus 20 of the present invention with the bifurcated vascular graft 30 of the present invention loaded into the deployment apparatus 20 prior to deployment of the graft 30. The first element 34 of the hollow tubular member of the Bifurcated vascular graft 30 is shown loaded in the first tube 23 of the member and the second element 36 of the hollow tubular member of the bifurcated vascular graft 30 is shown loaded in the second tube 25 of the member. The element 32 of the hollow tubular body of the bifurcated vascular graft 30 is shown loaded in the tube 21 of the graft body which is tapered at its second end 70 to allow easier movement through the blood vessels and facilitated reentry of the blood vessel. tube 21 of the graft body within the outermost tube 28. The first and second tubes 23 and 25 of the member, loaded, and the tube 21 of the loaded graft body, are all charged into the outermost tube 28. The first ends 72 and 74 of the first and second tubes 23 and 25 of the member, loaded, can rest adjacent the second end 70 of the tube 21 of the loaded graft body if the second end 70 of the tube 21 of the body of the graft is not tapered. However, if the second end 70 of the tube 21 of the graft body is tapered as shown in Figure 5, the first ends 72 and 74 of the first and second tubes 23 and 25 of the member, loaded, will not rest in vertical alignment. adjacent to the second end 70 of the tube 21 of the graft body. However, this configuration of the tubes contained in the deployment apparatus 20 will not affect the successful deployment of a one-piece bifurcated graft from the deployment apparatus 20. The first and second tubes 23 and 25 of the member can also be dimensioned from such that they are inserted into the interior of the tube 21 of the graft body at the same time. A perspective view of the second tube 25 of the hollow member of the deployment apparatus 20 of the present invention is shown in Figure 6A. The second hollow tube 25 includes a tapered tip 26, which can be removable and a guide wire 27 which is fixed to the tapered tip 26. The second element 34 of the hollow tubular member of the bifurcated vascular graft 30 is loaded at the first end 74 of the second tube 25 of the hollow member prior to insertion of the deployment apparatus into the body of a patient and the implant of the graft 30.

Figure 6B shows a partial view of a bifurcated blood vessel 80 shown cut away to illustrate the placement and placement of the deployment apparatus 20 of the present invention. The portions of the outermost tube 28 of the deployment apparatus 20 are also shown cut away to illustrate the positions of several of the other tubes which comprise the deployment apparatus 20. The first tube 23 of the member contains the first member element 34 hollow tubular vascular bifurcated graft 30, or any other bifurcated one-piece graft, and second tube 25 of the limb contains the second element 36 of the hollow tubular member of bifurcated vascular graft 30, or any other bifurcated graft in one piece. The first and second tubes 23 and 25 of the limb rest parallel to each other and adjacent to the tube 21 of the graft body which contains the element 32 of the graft body, the bifurcated vascular graft 30, or any other bifurcated graft in one piece. The first and second tubes 23 and 25 of the member and the tube 21 of the graft body are all contained within the outermost tube 28 of the deployment apparatus 20. In Figure 6B, the outermost tube 28 has been removed by pulling the bifurcation of the blood vessel whereby almost the entire tube 21 of the graft body is exposed. The guide wire 27 which is fixed to the second tube 25 of the member, is passed to the left side 82 of the bifurcated blood vessel 80. Figure 7A shows the deployment apparatus 20 of the present invention in the same position within the blood vessel 80 as that shown in Figure 6B with the exception that a portion The longer blood vessel 80 'is shown to illustrate the position of the tube 21 of the entire graft body within the non-bifurcated portion of a bifurcated blood vessel such as the aorta. The techniques commonly known in the prior art are used to position the deployment apparatus 20 and the guide wire 27 in the position shown in Figure 7A. First, the access of both iliac (or femoral) arteries is obtained and linings with hemostatic valves are inserted into the common left and right femoral arteries (or common left and right iliac). A separate guidewire is then passed proximally to the aorta from the right lining. Using a "cross" technique, an additional guidewire is brought from the left iliac (or femoral) lining to the right iliac (or femoral) lining. Following this, an angiographic catheter is passed from the left to the right over the guidewire. The wire is then removed, leaving the angiographic lining protruding from the right lining. The right lining is then removed leaving the angiographic catheter and the aortic guide wire protruding from the artery through the patient's skin. Digital pressure is applied for hemostasis. The guidewire 27 contained in the delivery apparatus 20 is inserted into the angiographic catheter and passed to the liner on the left side and removed until at least 2/3 or 3/4 of the wire 27 is on the left side. The deployment apparatus 20 is then loaded onto the second aortic guidewire on the right side. Simultaneously, the deployment apparatus 20 is passed to the head on the aortic wire (not shown) within the aorta while the second wire 27 on the left is further removed to remove the loose part that will occur when the device of deployment 20 moves toward the head or in a proximal manner as shown. The reverse placement of the guidewires, catheters and liners is carried out when the opposite lateral deployment is carried out, that is, when the deployment apparatus 30 is inserted into the opposite bifurcated blood vessel. Under fluoroscopic visualization, when the second tube 25 of the deployment apparatus member 20 containing the guidewire 27 reaches the aortic bifurcation, the total loosening in the guidewire 27 will go away and the guide wire 27 will appear as if it is coming almost straight from the side of the deployment apparatus 20. At this moment, the outermost tube 28 is retracted whereby the first and second tubes 23 and 25 of the member are exposed, which contain the first and second elements 34 and 36 of the hollow tubular member, as shown in Figure 7B. The additional traction of the guidewire 27 will then remove more of the guidewire 27 which is bent over itself within the tube 21 of the graft body as shown in Figure 6B. The positioning of the deployment apparatus 20 by further movement of the apparatus 20 in a proximal and remote manner with the additional gentle traction of the guide wire 27 will move the second tube 25 of the member through the bifurcation and into the left iliac artery 82 as it is shown in Figures 7B and 7C. Successful placement of the deployment apparatus 20 is obtained using the fluoroscopic visualization such that the tube 21 of the graft body is positioned near the bifurcation and below the renal arteries with the first and second tubes 23 and 25 of the member that is extend to the left and right iliac arteries 82 and 84. The first and second elements 34 and 36 of the hollow tubular member of the bifurcated vascular graft 30 are deployed by pulling the first and second tubes 23 and 25 of the remote member (or caudate) as shown in FIG. shown in Figures 7D and 7C. This process will discover the first and second elements 34 and 36 of the hollow tubular member which have been loaded into the first and second tubes 23 and 25 of the member by compressing the second and third small disposable tubes 48 and 50 which surround the first and second elements 34 and 36 of the hollow tubular member, respectively. The second and third small disposable tubes 48 and 50 self-expanding will expand to the diameter of the surrounding vessel of the right and left iliac arteries 84 and 82. Next the first tube 23 of the member, which is longer than the second tube 25 of the member, retracts again on the metal tube 29 while the second tube 25 of the member is pulled through the liner which still remains on the left side as previously described above with reference to the "cross" technique. Next, the ends 59 and 61 of the suture 57 which is sewn to the second end 40 of the element 32 of the hollow tubular body of the bifurcated vascular graft 30, are held firmly by the opposing drive while the metal tube 29 fixed to the tip The tapered 21 of the tube 21 of the graft body is urged in a direction towards the head to expose and deploy the element 32 of the hollow tubular body of the bifurcated vascular graft 30. The first compressed small disposable tube 42 is released by means of this and is autoexpande to the diameter of the aorta. The bifurcated vascular graft 30 of the present invention is now fully deployed. The first tube 23 of the member is then pushed towards the head inside the tube 21 of the graft body by a variable distance until the tapered bulb having the same diameter of the tube 21 of the graft body enters the caudate end of the body tube 21 of the graft to form a smooth tapered end with respect to the tube 21 of the graft body so that it will easily retract through the elements 34 and 36 of the bifurcated vascular graft member 30. The bifurcated vascular graft of the present invention can be comprised of any plastic or tissue materials, while the small disposable tubes - or support structures contained in the graft may be comprised of any suitable biocompatible material capable of graft reinforcement. The deployment apparatus may be comprised of any suitable biocompatible material including plastic. Although the foregoing embodiments of the present invention have been described in detail for the purposes of making a full description of the invention, the embodiments described above of the invention are proposed to be illustrative only. Numerous alternative modalities may be contemplated by those skilled in the art without departing from the spirit and scope of the following claims.

It is noted that in relation to this date the best method known by the applicant to carry out the aforementioned invention, is that which is clear from the present description of the invention.

Having described the invention as above, property is claimed as contained in the following

Claims (26)

1. A deployment apparatus for deploying a bifurcated graft having a main graft body which bifurcates towards the first and second members, characterized in that it comprises: a first member tube for loading the first member; a second member tube for charging the second member, wherein the first and second tubes of the loaded member are placed parallel to each other; a tube of the body of the graft for loading the body of the main graft wherein the tube of the body of the graft is placed adjacent to the parallel ends of the first and second tubes of the member; and an outermost tube for charging the first and second tubes of the limb and the tube of the graft body in such a way that all of the tubes are contained within the outermost tube.

2. The deployment apparatus according to claim 1, characterized in that it further comprises a metal tube for containing a guide wire, wherein the metal tube is insertable through the entire length of the apparatus.

3. The deployment apparatus according to claim 1, characterized in that it also comprises a first hemostatic valve connected to the first tube of the member.

4. The apparatus according to claim 3, characterized in that it also comprises a second hemostatic valve connected to the outermost tube.

5. The apparatus according to claim 1, characterized in that it further comprises a tapered tip capable of being fitted on an open end of the tube of the body of the graft.

6. The apparatus according to claim 1, characterized in that the second tube of the member comprises a first open end, a second closed tapered end and a guide wire fixed to the tapered end.

7. The apparatus according to claim 6, characterized in that the second tube of the member is shorter in length than the first tube of the member.

8. The apparatus according to claim 1, characterized in that the first tube of the member has a first diameter and the second tube of the member has a second diameter and the first and second diameters are approximately equal.

9. A deployment apparatus for deploying a bifurcated graft having a main graft body which. bifurcates in first and second members, characterized in that it comprises: a first tube of the member for loading the first member; a second tube of the member for loading the second member, wherein the first and second tubes of the member are placed parallel to each other; a tube of the body of the graft for loading the body of the main graft, wherein the first and second tubes of the member are contained within at least a portion of the tube of the body of the graft; and an outermost tube for charging the first and second tubes of the limb and the tube of the graft body in such a way that all of the tubes are contained within the outermost tube.

10. The deployment apparatus according to claim 9, characterized in that it further comprises a metal tube for containing a guide wire wherein the metal tube is insertable through the entire length of the apparatus.

11. The deployment apparatus according to claim 9, characterized in that it further comprises a first hemostatic valve connected to the first tube of the member.

12. The apparatus according to claim 11, characterized in that it also comprises a second hemostatic valve connected to the outermost tube.

13. The apparatus according to claim 9, characterized in that it further comprises a tapered tip capable of being adapted on an open end of the tube of the body of the graft.

14. The apparatus according to claim 9, characterized in that the second tube of the member comprises a first open end, a second tapered, closed end, and a guide wire fixed to the tapered end.

15. The apparatus according to claim 14, characterized in that the second tube of the member is shorter in length than the first tube of the member.

16. The apparatus according to claim 9, characterized in that the first tube of the member has a first diameter and the second tube of the member has a second diameter and the first and second diameters are approximately equal.

17. A deployment apparatus according to claim 1, characterized in that the tube of the graft body is positioned at a distance from the first and second tubes of the member.

18. A deployment apparatus according to claim 17, characterized in that the second tube of the member has an open far end for receiving a second member on the graft and a closed proximal end.

19. A deployment apparatus according to claim 18, characterized in that it also comprises a wire fixed to the closed proximal end so that the proximal retraction of the wire will retract the second tube of the member proximally with respect to the tube of the body of the graft to release the second member .

20. A deployment apparatus according to claim 1, characterized in that the tube of the graft body has an open proximal end so that the distal advancement of the tube of the graft body releases the main graft body.

21. A deployment apparatus according to claim 20, characterized in that it also comprises a tapered tip on the end remote from the tube of the body of the graft.

22. A deployment apparatus according to claim 9, characterized in that the tube of the graft body is positioned at a distance from the first and second tubes of the member.

23. A deployment apparatus according to claim 22, characterized in that the second tube of the member has an open far end for receiving a second member on the graft and a closed proximal end.

24. In addition, a deployment apparatus according to claim 23, characterized in that it further comprises a wire fixed to the closed proximal end so that the proximal retraction of the wire will retract the second tube of the member proximally with respect to the tube of the body of the graft to release the second member. .

25. A deployment apparatus according to claim 9, characterized in that the tube of the graft body has an open proximal end so that the remote advancement of the tube of the graft body releases the main graft body.

26. A deployment apparatus according to claim 25, characterized in that it also comprises a tapered tip on the end remote from the tube of the body of the graft.