PATENT DOCUMENT

Abstract:
Sealable and repositionable implant devices are provided with one or more improvements that increase the ability of implants such as endovascular grafts to be precisely deployed or re-deployed, with better in situ accommodation to the local anatomy of the targeted recipient anatomic site, and/or with the ability for post-deployment adjustment to accommodate anatomic changes that might compromise the efficacy of the implant. A surgical implant includes an implant body and a selectively adjustable assembly attached to the implant body, having adjustable elements, and operable to cause a configuration change in a portion of the implant body and, thereby, permit implantation of the implant body within an anatomic orifice to effect a seal therein under normal physiological conditions.

Full Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application is a continuation of U.S. patent application Ser. No. 13/339,236, filed Dec. 28, 2011, which claims priority to U.S. Provisional Patent Application No. 61/428,114, filed Dec. 29, 2010. U.S. patent application Ser. No. 13/339,236 is a continuation-in-part of U.S. patent application Ser. No. 11/888,009, filed Jul. 31, 2007, now U.S. Pat. No. 8,252,036, which claims priority to U.S. Provisional Patent Application Nos. 60/834,401 filed Jul. 31, 2006 and 60/834,627 filed Aug. 1, 2006. U.S. patent application Ser. No. 13/339,236 is also a continuation-in-part of U.S. patent application Ser. No. 12/822,291, filed Jun. 24, 2010, now U.S. Pat. No. 9,408,607, which claims priority to U.S. Provisional Patent Application No. 61/222,646, filed Jul. 2, 2009. All of the above-referenced patents and applications are incorporated by reference herein in their entireties. 
     
    
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
       [0002]    Not Applicable 
       FIELD OF THE INVENTION 
       [0003]    The present invention relates to the field of surgical implant devices and methods for their manufacture and use. Among the exemplary embodiments of the present invention are improvements in sealing and retention medical devices particularly applicable to vascular surgery and the treatment of aneurysms or other luminal defects in other anatomic conduits, such as sealing and retention of replacement heart valves. 
       BACKGROUND OF THE INVENTION 
       [0004]    Medical and surgical implants are placed often in anatomic spaces where it is desirable for the implant to conform to the unique anatomy of the targeted anatomic space and secure a seal therein, preferably without disturbing or distorting the unique anatomy of that targeted anatomic space. 
         [0005]    While the lumens of most hollow anatomic spaces are ideally circular, in fact, the cross-sectional configurations of most anatomic spaces are, at best, ovoid, and may be highly irregular. Such lumenal irregularity may be due to anatomic variations and/or to pathologic conditions that may change the shape and topography of the lumen and its associated anatomic wall. Examples of anatomic spaces where such implants may be deployed include, but are not limited to, blood vessels, the heart, other vascular structures, vascular defects (such as thoracic and abdominal aortic aneurysms), the trachea, the oropharynx, the esophagus, the stomach, the duodenum, the ileum, the jejunum, the colon, the rectum, ureters, urethras, fallopian tubes, biliary ducts, pancreatic ducts, or other anatomic structures containing a lumen used for the transport of gases, blood, or other liquids or liquid suspensions within a mammalian body. 
         [0006]    For a patient to be a candidate for existing endograft methods and technologies, to permit an adequate seal, a proximal neck of, ideally, at least 12 mm of normal aorta must exist downstream of the left subclavian artery for thoracic aortic aneurysms or between the origin of the most inferior renal artery and the origin of the aneurysm in the case of abdominal aneurysms. Similarly, ideally, at least 12 mm of normal vessel must exist distal to the distal extent of the aneurysm for an adequate seal to be achieved. 
         [0007]    Migration of existing endografts has also been a significant clinical problem, potentially causing leakage and profusion of aneurysms and/or compromising necessary vascular supplies to arteries such as the carotid, subclavian, renal, or internal iliac vessels. This problem only has been addressed partially by some existing endograft designs, in which barbs or hooks have been incorporated to help retain the endograft at its intended site. However, most existing endograft designs are solely dependent on radial force applied by varying length of stent material to secure a seal against the recipient vessel walls. 
         [0008]    Because of the limitations imposed by existing vascular endograft devices and endovascular techniques, a significant number of abdominal and thoracic aneurysms repaired in the U.S. are still managed though open vascular surgery, instead of the lower morbidity of the endovascular approach. 
         [0009]    Pre-sizing is required currently in all prior art endografts. Such pre-sizing based on CAT-scan measurements is a significant problem. This leads, many times, to mis-sized grafts. In such situations, more grafts segments are required to be placed, can require emergency open surgery, and can lead to an unstable seal and/or migration. Currently there exists no endograft that can be fully repositioned after deployment. 
         [0010]    Thus, a need exists to overcome the problems with the prior art systems, designs, and processes as discussed above. 
       SUMMARY OF THE INVENTION 
       [0011]    The invention provides surgical implant devices and methods for their manufacture and use that overcome the hereinafore-mentioned disadvantages of the heretofore-known devices and methods of this general type and that provide such features with improvements that increase the ability of such an implant to be precisely positioned and sealed, with better in situ accommodation to the local anatomy of the targeted anatomic site. The invention provide an adjustment tool that can remotely actuate an adjustment member(s) that causes a configuration change of a portion(s) of an implant, which configuration change includes but is not limited to diameter, perimeter, shape, and/or geometry or a combination of these, to create a seal and provide retention of an implant to a specific area of a target vessel or structure. 
         [0012]    One exemplary aspect of the present invention is directed towards novel designs for endovascular implant grafts, and methods for their use for the treatment of aortic aneurysms and other structural vascular defects. An endograft system for placement in an anatomic structure or blood vessel is disclosed in which an endograft implant comprises, for example, a non-elastic tubular implant body with at least an accommodating proximal end. Accommodating, as used herein, is the ability to vary a configuration in one or more ways, which can include elasticity, expansion, contraction, and changes in geometry. Both or either of the proximal and distal ends in an implant according to the present invention further comprise one or more circumferential expandable sealable collars and one or more expandable sealing devices, capable of being expanded upon deployment to achieve the desired seal between the collar and the vessel&#39;s inner wall. Exemplary embodiments of such devices can be found in co-pending U.S. patent application Ser. No. 11/888,009, filed Jul. 31, 2007, and Ser. No. 12/822,291, filed Jun. 24, 2010, which applications have been incorporated herein in their entireties. Further embodiments of endovascular implants according to the present invention may be provided with retractable retention tines or other retention devices allowing an implant to be repositioned before final deployment. In other embodiments, the implant can be repositioned after final deployment. An endograft system according to the present invention further comprises a delivery catheter with an operable tubular sheath capable of housing a folded or compressed endograft implant prior to deployment and capable of retracting or otherwise opening in at least its proximal end to allow implant deployment. The sheath is sized and configured to allow its placement via a peripheral arteriotomy site, and is of appropriate length to allow its advancement into the aortic valve annulus, ascending aorta, aortic arch, and thoracic or abdominal aorta, as required for a specific application. 
         [0013]    While some post-implantation remodeling of the aortic neck proximal to an endovascular graft (endograft) has been reported, existing endograft technology does not allow for the management of this condition without placement of an additional endograft sleeve to cover the remodeled segment. 
         [0014]    Exemplary endografts of the present invention as described herein allow for better accommodation by the implant of the local anatomy, using a self-expandable or compressible gasket for the sealing interface between the endograft collar and the recipient vessel&#39;s inner wall. Furthermore, exemplary endografts of the present invention as disclosed herein are provided with a controllably releasable disconnect mechanism that allows remote removal of an adjustment tool and locking of the retained sealable mechanism after satisfactory positioning and sealing of the endograft. In some exemplary embodiments according to the present invention, the controllably releasable disconnect mechanism may be provided in a manner that allows post-implantation re-docking of an adjustment member to permit post-implantation repositioning and/or resealing of an endograft subsequent to its initial deployment. 
         [0015]    In other exemplary applications encompassed by the present invention, improved devices for sealing other medical devices such as vascular cannulae may be provided. The present invention further includes novel designs for vascular cannulae to be used when bi-caval cannulation of the heart is indicated, eliminating the need to perform circumferential caval dissection and further reducing the tissue trauma caused by prior art balloon or other bypass cannulae. While the vascular cannulae of the present invention are inserted and positioned by a surgeon in the standard fashion, the need for circumferential dissection of the cavae and tourniquet placement is obviated. After the vascular cannulae of the present invention are positioned and secured with purse string sutures, the surgeon deploys the adjustable sealing devices of the cannulae by turning an adjustment tool or torque wire. Once the sealing devices are deployed, all of the venous return is diverted. The sealing devices deploy around the distal ends of the cannulae and allow blood to flow through the lumen of the cannulae, but not around the sealing devices. Use of these cannulae minimizes the chance of caval injury by eliminating the need for circumferential dissection. Additionally, the configuration of the adjustable sealing device in relation to the cannula is such that the adjustable sealing device is “flush” with the cannula so that no acute change in diameter exists along the external surface of the cannula, which serves to avoid tissue trauma during insertion and withdrawal into and out of bodily structures. 
         [0016]    The present invention addresses several major problems presented by existing designs for balloon cannulae. In various exemplary embodiments according to the present invention, the lumens are configured such that a cannula with an adjustable sealing device can be deployed without compromising either the flow within the principle lumen of the cannula or the seal between the cannula and the structure within which the cannula lies. Moreover, a disclosed example of a cannula according to the present invention is provided with a trough within the cannula body at its distal end in which the adjustable sealing device member lies such that, when undeployed during insertion and withdrawal, there is a smooth interface between the external cannula wall and the undeployed sealing device, allowing for smoother, easier, and safer insertion and withdrawal. 
         [0017]    Moreover, existing designs for balloon cannulae are unable to provide a truly symmetrical placement of an inflated balloon around a central lumen of standard diameter. The asymmetry that results with conventional balloon inflation is sufficient to displace the lumen from the true center of the endovascular lumen in which the balloon cannula is placed, resulting in unpredictable and suboptimal flow characteristics therethrough. The altered hemodynamics of such flow with an existing balloon cannula increases the likelihood of intimal vascular injury and clot or plaque embolization. Vascular cannulae of the present invention achieve the surprising result of having the flow characteristics of a non-balloon cannula by maintaining the preferred laminar flow characteristics of a circular main lumen of consistent diameter, positioned and maintained in or near the center of vascular flow by an adjustable sealing device originally provided within a recessed trough in the exterior wall of the cannula, with accessory lumens contained within an externally circular cannular wall. This allows for better seal, less vascular trauma, and easier vascular ingress and egress. 
         [0018]    In addition, vascular cannulae according to the present invention may be provided with retractable stabilizing elements to anchor the inflated balloon within a vessel lumen during use. Such stabilizing elements further make use of the trough within the cannula body, with the stabilizing elements retracting into this trough during insertion and removal, allowing for smooth and trauma-free entry and egress of the cannula. 
         [0019]    Certain aspects of the present invention are directed towards novel designs for sealable endovascular implant grafts, and methods for their use for the treatment of aortic aneurysms and other structural vascular defects or for heart valve replacements. Various embodiments as contemplated within the present invention may include any combination of exemplary elements as disclosed herein or in the co-pending patent applications referenced above. 
         [0020]    In an exemplary embodiment according to the present invention, a sealable vascular endograft system for placement in a vascular defect is provided, comprising an elongated main implant delivery catheter with an external end and an internal end for placement in a blood vessel with internal walls. In such an exemplary embodiment, the main implant delivery catheter further comprises a main implant delivery catheter sheath that may be openable or removable at the internal end and a main implant delivery catheter lumen containing within a compressed or folded endovascular implant. Further, in such an exemplary embodiment, an endovascular implant comprises a non-elastic tubular implant body with an accommodating proximal end terminating in a proximal sealable circumferential collar that may be expanded by the operator to achieve a fluid-tight seal between the proximal sealable circumferential collar and the internal walls of the blood vessel proximal to the vascular defect. Moreover, in such an exemplary embodiment, an endovascular implant may further comprises a non-elastic tubular implant body with an accommodating distal end terminating in a distal sealable circumferential collar controlled by a distal variable sealing device, which may be expanded by the operator to achieve a fluid-tight seal between the distal sealable circumferential collar and the internal walls of the blood vessel distal to the vascular defect. 
         [0021]    In a further exemplary embodiment according to the present invention, an implant interface is provided for a sealable attachment of an implant to a wall within the lumen of a blood vessel or other anatomic conduit. 
         [0022]    In a yet further exemplary embodiment according to the present invention, an implant gasket interface is provided for a sealable attachment of an implant to a wall within the lumen of a blood vessel or other anatomic conduit, wherein the sealable attachment provides for auto-adjustment of the seal while maintaining wall attachment to accommodate post-implantation wall remodeling. 
         [0023]    Still other exemplary embodiments of endografts and endograft delivery systems according to the present invention serve as universal endograft cuffs, being first placed to offer their advantageous anatomic accommodation capabilities, and then serving as a recipient vessel for other endografts, including conventional endografts. 
         [0024]    Furthermore, exemplary embodiments of endografts and endograft delivery systems according to the present invention may be provided with a mechanism to permit transfer of torque or other energy from a remote operator to an adjustment member comprising a sealable, adjustable circumferential assembly controlled by an adjustment tool, which may be detachable therefrom and may further cause the assembly to lock upon detachment of the tool. In some exemplary embodiments of the present invention, the variable sealing device may be provided with a re-docking element that may be recaptured by subsequent operator interaction, allowing redocking and repositioning and/or resealing of the endograft at a time after its initial deployment. 
         [0025]    Moreover, the various exemplary embodiments of the present invention as disclosed herein may constitute complete endograft systems, or they may be used as components of a universal endograft system as disclosed in co-pending patent applications that may allow the benefits of the present invention to be combined with the ability to receive other endografts. 
         [0026]    Finally, the present invention encompasses sealable devices that may be used in other medical devices such as adjustable vascular cannulas or other medical or surgical devices or implants, such as aortic valves. 
         [0027]    With the foregoing and other objects in view, there is provided, in accordance with the invention, a surgical implant including an implant body and a selectively adjustable assembly attached to the implant body, having adjustable elements, and operable to cause a configuration change in a portion of the implant body and, thereby, permit implantation of the implant body within an anatomic orifice to effect a seal therein under normal physiological conditions. 
         [0028]    The preceding description is presented only as an exemplary application of the devices and methods according to the present invention. 
         [0029]    Although the invention is illustrated and described herein as embodied in surgical implant devices and methods for their manufacture and use, it is, nevertheless, not intended to be limited to the details shown because various modifications and structural changes may be made therein without departing from the spirit of the invention and within the scope and range of equivalents of the claims. Additionally, well-known elements of exemplary embodiments of the invention will not be described in detail or will be omitted so as not to obscure the relevant details of the invention. 
         [0030]    Additional advantages and other features characteristic of the present invention will be set forth in the detailed description that follows and may be apparent from the detailed description or may be learned by practice of exemplary embodiments of the invention. Still other advantages of the invention may be realized by any of the instrumentalities, methods, or combinations particularly pointed out in the claims. 
         [0031]    Other features that are considered as characteristic for the invention are set forth in the appended claims. As required, detailed embodiments of the present invention are disclosed herein; however, it is to be understood that the disclosed embodiments are merely exemplary of the invention, which can be embodied in various forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one of ordinary skill in the art to variously employ the present invention in virtually any appropriately detailed structure. Further, the terms and phrases used herein are not intended to be limiting; but rather, to provide an understandable description of the invention. While the specification concludes with claims defining the features of the invention that are regarded as novel, it is believed that the invention will be better understood from a consideration of the following description in conjunction with the drawing figures, in which like reference numerals are carried forward. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0032]    The accompanying figures, where like reference numerals refer to identical or functionally similar elements throughout the separate views, which are not true to scale, and which, together with the detailed description below, are incorporated in and form part of the specification, serve to illustrate further various embodiments and to explain various principles and advantages all in accordance with the present invention. Advantages of embodiments of the present invention will be apparent from the following detailed description of the exemplary embodiments thereof, which description should be considered in conjunction with the accompanying drawings in which: 
           [0033]      FIG. 1  is a fragmentary, perspective view of an exemplary embodiment of a proximal aspect of a selectively expandable and contractable endograft according to the present invention with the endograft in a relatively expanded form; 
           [0034]      FIG. 2  is a fragmentary, perspective view of the selectively expandable and contractable endograft of  FIG. 1  with the endograft in a relatively contracted form; 
           [0035]      FIG. 3  is a fragmentary, perspective view of another exemplary embodiment of a proximal aspect of an endograft according to the present invention further incorporating a lattice structure; 
           [0036]      FIG. 4A  is a fragmentary, perspective view of the endograft of  FIG. 3  with the endograft in a relatively contracted form; 
           [0037]      FIG. 4B  is a fragmentary, perspective view of the endograft of  FIG. 3  with the endograft in a partially expanded form; 
           [0038]      FIG. 4C  is a fragmentary, perspective view of the endograft of  FIG. 3  with the endograft in a fully expanded form; 
           [0039]      FIG. 5A  is a fragmentary, partially hidden, perspective view of an exemplary embodiment of a microcylinder locking mechanism with an associated adjustment tool prior to engagement of the microcylinder locking mechanism by the adjustment tool; 
           [0040]      FIG. 5B  is a fragmentary, partially hidden, perspective view of the microcylinder locking mechanism and adjustment tool of  FIG. 5B  with engagement of the microcylinder locking mechanism by the adjustment tool; 
           [0041]      FIG. 5C  is a fragmentary, partially hidden, perspective view of an exemplary embodiment of the microcylinder locking mechanism and adjustment tool of  FIG. 5B  after adjustment and disengagement of the adjustment tool from the microcylinder locking mechanism; 
           [0042]      FIG. 6A  is an axial cross-sectional view of the microcylinder and guide bullet along section line A-A of  FIG. 5A  with tines captures in striations of the microcylinder; 
           [0043]      FIG. 6B  is an axial cross-sectional view of the adjustment tool along section line B-B of  FIG. 5A ; 
           [0044]      FIG. 6C  is an axial cross-sectional view of the microcylinder along section line C-C of  FIG. 5B ; 
           [0045]      FIG. 6D  is an axial cross-sectional view of the microcylinder, the guide bullet, and the tool sheath along section line D-D of  FIG. 5B  without the adjustment member with the tines removed from the microcylinder by the adjustment tool; 
           [0046]      FIG. 6E  is an axial cross-sectional view of another exemplary embodiment of a microcylinder locking mechanism and adjustment tool sheath according to the invention where the adjustment tool also has striations having a rectangular cross-sectional shape and has a smooth exterior; 
           [0047]      FIG. 6F  is an axial cross-sectional view of yet another exemplary embodiment of a microcylinder locking mechanism according to the invention in which the microcylinder has striations with a triangular cross-sectional shape and with the tines caught in the striations of the microcylinder; 
           [0048]      FIG. 6G  is an axial cross-sectional view of the microcylinder locking mechanism of  FIG. 6F  and an adjustment tool according to the invention in which the tines are removed from the microcylinder by the adjustment tool; 
           [0049]      FIG. 7A  is a longitudinal, partial cross-sectional view of an exemplary embodiment of an adjustment control locking mechanism according to the present invention with a controllable catch mechanism disengaged; 
           [0050]      FIG. 7B  is a longitudinal, partial cross-sectional view of the adjustment control locking mechanism of  FIG. 7A  with the controllable catch mechanism engaged. 
           [0051]      FIG. 8A  is a fragmentary, partially hidden, perspective view of an exemplary embodiment of a microcylinder locking mechanism according to the invention with internal locking tines of unequal length and with an associated adjustment tool sheath prior to engagement of the microcylinder locking mechanism by the adjustment tool sheath; 
           [0052]      FIG. 8B  is a fragmentary, partially hidden, perspective view of the microcylinder locking mechanism and adjustment tool sheath of  FIG. 7A  with engagement of the microcylinder locking mechanism by the adjustment tool sheath; 
           [0053]      FIG. 8C  is a fragmentary, partially hidden, perspective view of the microcylinder locking mechanism and adjustment tool sheath of  FIG. 7B  after adjustment and disengagement of the microcylinder locking mechanism with the adjustment tool sheath. 
           [0054]      FIG. 9A  is an axial cross-sectional view of retention tines sheathed by an expanded compressible foam gasket in an exemplary endograft according to the present invention with the tines in a non-extended state; 
           [0055]      FIG. 9B  is a fragmentary, perspective view of the retention tines of  FIG. 9A  exposed and deployed through a compressible foam gasket by an expanded sealable collar in an exemplary endograft according to the present invention; 
           [0056]      FIG. 10A  is a fragmentary, axial cross-sectional view of an exemplary endovascular interface cuff according to the present invention, in which the interface cuff has been positioned over an endovascular guidewire to a desired recipient site in the aorta proximal to an aortic aneurysm sac but has not been expanded therein; 
           [0057]      FIG. 10B  is a fragmentary, transverse cross-sectional view of the interface cuff of  FIG. 10A ; 
           [0058]      FIG. 11A  is a fragmentary, axial cross-sectional view of the interface cuff of  FIG. 10A , with expansion of the endovascular interface cuff in the aorta to achieve a seal and with retention tine engagement of the aortic wall in the desired recipient site proximal to the aortic aneurysm sac at the level of A-A′; 
           [0059]      FIG. 11B  is a fragmentary, transverse cross-sectional view of the interface cuff of  FIG. 11A ; 
           [0060]      FIG. 12  is a fragmentary, axial cross-sectional view of the interface cuff of  FIG. 10A  with delivery of an endograft secured within the rigid cuff of the interface cuff; 
           [0061]      FIG. 13  is a fragmentary, axial cross-sectional view of the interface cuff of  FIG. 12  with the guidewire removed and with the adjustment tool detached and removed; 
           [0062]      FIG. 14A  is a fragmentary, perspective view of an exemplary embodiment of an actively controllable endograft according to the present invention in which a latticework external to the lumen of an endograft can be radially displaced by controlled rotation of an adjustment member, the lattice structure being in a contracted state; 
           [0063]      FIG. 14B  is a fragmentary, perspective view of the actively controllable endograft of  FIG. 14A  in which the lattice structure is in an expanded state; 
           [0064]      FIG. 15A  is a side perspective view of an exemplary embodiment of an adjustable vascular cannula according to the present invention; 
           [0065]      FIG. 15B  is a side perspective and partially hidden view of the adjustable vascular cannula of  FIG. 15A  within a recipient blood vessel with an adjustable seal device in a non-deployed, contracted position; and 
           [0066]      FIG. 15C  is a side perspective and partially hidden view of the adjustable vascular cannula of  FIG. 15B  with the adjustable seal device in a deployed, expanded position. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0067]    As required, detailed embodiments of the present invention are disclosed herein; however, it is to be understood that the disclosed embodiments are merely exemplary of the invention, which can be embodied in various forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present invention in virtually any appropriately detailed structure. Further, the terms and phrases used herein are not intended to be limiting; but rather, to provide an understandable description of the invention. While the specification concludes with claims defining the features of the invention that are regarded as novel, it is believed that the invention will be better understood from a consideration of the following description in conjunction with the drawing figures, in which like reference numerals are carried forward. 
         [0068]    Alternate embodiments may be devised without departing from the spirit or the scope of the invention. Additionally, well-known elements of exemplary embodiments of the invention will not be described in detail or will be omitted so as not to obscure the relevant details of the invention. 
         [0069]    Before the present invention is disclosed and described, it is to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. The terms “a” or “an”, as used herein, are defined as one or more than one. The term “plurality,” as used herein, is defined as two or more than two. The term “another,” as used herein, is defined as at least a second or more. The terms “including” and/or “having,” as used herein, are defined as comprising (i.e., open language). The term “coupled,” as used herein, is defined as connected, although not necessarily directly, and not necessarily mechanically. 
         [0070]    Relational terms such as first and second, top and bottom, and the like may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. The terms “comprises,” “comprising,” or any other variation thereof are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. An element proceeded by “comprises . . . a” does not, without more constraints, preclude the existence of additional identical elements in the process, method, article, or apparatus that comprises the element. 
         [0071]    As used herein, the term “about” or “approximately” applies to all numeric values, whether or not explicitly indicated. These terms generally refer to a range of numbers that one of skill in the art would consider equivalent to the recited values (i.e., having the same function or result). In many instances these terms may include numbers that are rounded to the nearest significant figure. 
         [0072]    Herein various embodiments of the present invention are described. In many of the different embodiments, features are similar. Therefore, to avoid redundancy, repetitive description of these similar features may not be made in some circumstances. It shall be understood, however, that description of a first-appearing feature applies to the later described similar feature and each respective description, therefore, is to be incorporated therein without such repetition. 
         [0073]    Described now are exemplary embodiments of the present invention. Referring now to the figures of the drawings in detail and, first, particularly to  FIG. 1  thereof, there is shown a perspective view of an exemplary embodiment of the proximal aspect of a sealable endograft system  1000  according to the present invention, in which the endograft is in a relatively expanded form.  FIG. 2  is a perspective view of the embodiment of the proximal aspect of a sealable endograft system  1000  according to the present invention of  FIG. 1 , showing the endograft in a relatively contracted form. This exemplary endograft system  1000  has the ability to be selectively expanded and contracted to a diameter selected by the implanting physician. In general, the endograft system  1000  has, along its intermediate extent and, possibly, also at its distal portion (at the downstream end of the prosthesis), a relatively constant diameter portion. At its proximal portion (at the upstream end of the prosthesis), the endograft system  1000  is able to impart a configuration change to selectively adjustable portion of the implant. Features of the inventive controllable endograft system  1000  are described in further detail in U.S. patent application Ser. No. 11/888,009, filed Jul. 31, 2007, and Ser. No. 12/822,291, filed Jun. 24, 2010, which have been incorporated herein and detail of which is not replicated herein for the sake of brevity. 
         [0074]    The exemplary sealable endograft system  1000  shown in  FIGS. 1 and 2  comprises a hollow tubular endograft body  1005  having an accommodating proximal cuff  1010  and an intermediate, substantially rigid, tubular member  1015 . The distal end of such an endograft (not shown in  FIGS. 1 and 2 ) may be any or all of accommodating, elastic, rigid, stent-laden, or even replicate the proximal end, depending upon the various exemplary embodiments according to the present invention. A selectively adjustable circumferential assembly  1020  is disposed at the proximal cuff  1010 . Contained in one exemplary embodiment of the circumferential assembly  1020  is a circumferential channel enclosing an adjustment member  1025  (indicated only diagrammatically with a solid line). The adjustment member  1025  causes the expansion/contraction of the accommodating proximal cuff  1010  by looping around the perimeter and by being lengthened or shortened, respectively. The adjustment member  1025 , for example, interacts with a control device  1030  that is operable to cause an increase or decrease in the circumference of the circumferential loop  1025  by the application of rotational torque to the distal aspect of an adjustment tool  1035  emerging from the control device  1030 . The adjustment member  1025  can be integral with the adjustment tool  1035  in an exemplary embodiment of the circumferential assembly  1020 , or can be removable as shown, for example, in  FIG. 10A . 
         [0075]    Such an adjustment member  1025  may take many forms in the present invention. In one exemplary embodiment according to the present invention, the adjustment member  1025  is a micro-threaded cable that is fixed at one end to the control device  1030 , which is in the form of a microcylinder, and the adjustment tool  1035  threads through a threaded aspect of the microcylinder  1030  in order to effect a change in the circumference of the proximal cuff  1010 . A forwardly imposed torque on the adjustment tool  1035  cause expansion of the adjustment tool  1035 . Expansion of the adjustment member  1025  in its circumferential extent has the effect of expanding the proximal aspect of the sealable endograft system  1000  to allow for precise sealing of the sealable endograft system  1000  within a recipient blood vessel such as the aorta (not shown in  FIG. 1 or 2 ). Conversely, reverse torque on the adjustment tool  1035  has the effect of decreasing the circumference of the circumferential loop of the adjustment member  1025  and, thus, contracting the proximal aspect of the sealable endograft system  1000 , allowing for re-positioning as needed. In  FIGS. 1 and 2 , the adjustment tool  1035  may extend distally through the lumen of the sealable endograft system  1000 . Alternatively, the adjustment tool  1035  may extend distally through a separate lumen provided in the sealable endograft system  1000  (not shown in  FIG. 1 or 2 ). 
         [0076]      FIGS. 3 and 4A to 4C  are perspective views of yet another exemplary embodiment of a proximal aspect of a sealable endograft system  1000  according to the present invention that further incorporates a stent or lattice structure  1041  (which, in another embodiment, can be a compressible foam gasket). The lattice structure  1041  is provided with a lattice interruption  1045  to allow for variations in the circumference of the proximal aspect of the endograft. This lattice interruption  1045  may take the form of a V-shape as shown in  FIGS. 4B and 4C  or may be otherwise configured. As in  FIGS. 1 and 2 , the sealable endograft system  1000  of  FIG. 3  also has an accommodating proximal cuff  1010  which encloses the terminal lattice structure  1040  as shown and also encloses an adjustment member  1025  that loops through a control device  1030  that is provided to allow increase or decrease in the circumference of the, e.g., circumferential loop of the adjustment member  1025  by the application of rotational torque to the distal aspect of the adjustment tool  1035  emerging from the control device  1030 . The progression of  FIGS. 4A to 4C  shows the endograft in a relatively contracted form in  FIG. 4A , in a partially expanded form in  FIG. 4B , and in a fully expanded form in  FIG. 4C . As the lattice interruption  1045  is closed in  FIGS. 3 and 44 , it can be seen only in  FIGS. 4B and 4C . One exemplary configuration for the lattice interruption  1045  can be a woven material that is stretched in the expanded state and attached to the lattice  1041  and, when allowed to reduce, the woven material resist buckling. This configuration allows the diameter to increase beyond the maximum diameter that the graft will allow with the stent alone. 
         [0077]      FIG. 5A  shows an exemplary embodiment of the control device  1030  in the form of a microcylinder locking mechanism  1050 . This locking mechanism  1050  is changed from a locked state to an unlocked state by an adjustment tool  1060 , which comprises a tool sheath  1062  having a keyed collar portion  1065 . The adjustment tool  1060  is fixed, in both the longitudinal and radial extents, to the remote adjustment tool  1035 . The progression of  FIGS. 5A to 5C  show how the locking mechanism  1050  is changed from the locked state (in which adjustment of the adjustment member  1025  is prohibited) to the unlocked state (in which adjustment of the adjustment member  1025  is permitted), and, then, back to the locked state. 
         [0078]    Before explaining the change between states, the configuration of an exemplary embodiment of the locking mechanism  1050  is described further. The exterior of the locking mechanism  1050  is comprised of a microcylinder  1052  having a set of circumferentially spaced-apart, interior striations  1055 . The locking mechanism  1050  is longitudinally and rotationally fixed to the proximal cuff  1010 . A guide bullet  1070  is received within the hollow, internally striated microcylinder  1052 . The guide bullet  1070  has a longitudinal threaded bore that received therein (in a threaded manner) the adjustment member  1025 . The adjustment member  1025  completely traverses the bore of the guide bullet  1070  and terminates distally of the guide bullet  1070  in a keyed block  1075  that is rotationally fixed to the adjustment member  1025 . The guide bullet  1070  has at least two opposing, flexible tines  1072  that extend radially outward, in a natural state that, together, has a diameter greater than the internal diameter of the locking microcylinder  1052  (the tines can, as well, be spring loaded outwardly). The tines  1072  have a terminal portion that is shaped to fit within a corresponding shaped of each striation  1055  within the microcylinder  1052 . As such, when the tines  1072  are compressed and the guide bullet  1070  is placed within the microcylinder with the adjustment member  1025  threaded therewithin, the tines  1072  press outwardly against the internal surface of the microcylinder  1052  and, when appropriately rotated therein, the tines  1072  each lock within a respective opposing one of the striations  1055 . In such a state, the tines  1072  both form-fittingly and force-fittingly lock within inner striations  1055  when unconstrained. If, for example, there were three tines  1072  separated by 120 degrees each, then the tines  1072  would each lock within a respective one of the striations  1055  that are, also, 120 degrees apart along the interior surface of the microcylinder  1052 . The frictional force of the tines  1072  against the inside surface of the microcylinder  1052  is sufficiently strong to prevent longitudinal movement of the guide bullet  1070 , even if the keyed block  1075  is rotated unless the tines  1072  are removed from their locked position against the interior surface of the microcylinder. In such a configuration, the microcylinder  1052  and the guide bullet  1070  prevent rotation of the adjustment member  1025  without, not only a particular external force applied thereto, but also a removal of the tines  1072  from the interior surface of the microcylinder  1052 . 
         [0079]    Rotation of the adjustment member  1025 , therefore, is carried out with the adjustment tool  1060 . The adjustment tool  1060  provides both the ability to rotate the keyed block  1075  but also the ability to separate the tines  1072  from the interior surface of the microcylinder  1052 . To carry out these functions, the tool sheath  1062  has a sufficient cylindrical length to slide between the tines  1072  and the interior surface of the microcylinder  1052  anywhere the tines  1072  are contacting the interior surface. As such, the longitudinal length of the tool sheath  1062  can be, but does not necessarily have to be, as long as the microcylinder  1052 .  FIG. 5A  shows the microcylinder  1052  with the guide bullet  1070  in a locked position, prior to interface by the remote adjustment tool  1060 . When the adjustment tool  1060  is slid into the microcylinder  1052 , as shown in the progression of  FIGS. 5A to 5B , the smooth interior surface of the tool sheath  1062  first slides along the outer surface of the tines and, then, along and past the distal ends of the tines  1072 , at which time the tines  1072  no longer contact the interior surface of the microcylinder  1052 . The orientation of the microcylinder locking mechanism  1050  and the adjustment tool  1060  in  FIG. 5B  now allows for repositioning of the adjustment member  1025  and relocation of the guide bullet  1070  within the microcylinder  1052 . 
         [0080]    The keyed collar portion  1065  has a distal taper  1067  that reduces the outer diameter of the tool sheath  1062  inwards to such an extent that it acts as a funnel to direct the keyed block  1075  directly into the radial center of the keyed collar portion  1065 . At the proximal-most end of the collar portion  1065  is an internal key  1069  having an internal circumferential shape corresponding to an external circumferential shape of the keyed block  1075 . As such, when the adjustment tool  1060  is inserted into the microcylinder  1052  and releases the tines  1072  from the interior surface thereof, the tool sheath  1062  can pass the tines  1072  (wherever they may be inside the microcylinder  1052 ) sufficiently far to permit the keyed block  1075  to slide along the interior distal taper  1067  and press against the internal bore of the key  1069 . With slight rotation either way of the adjustment tool  1060  (by rotation of the adjustment tool  1035 ), the keyed block  1075  will fall into the internal bore of the key  1069  in a form-fit, thereby enabling rotation of the adjustment member  1025  (via keyed block  1075 ) in a corresponding manner to any rotation of the adjustment tool  1035  by a user. 
         [0081]    The locking mechanism  1050  is longitudinally and rotationally fixed to the circumferential assembly  1020  such that rotation of the locking mechanism  1050  in a first direction causes a contraction of the circumferential assembly  1020  and rotation of the locking mechanism  1050  in the opposition direction causes an expansion of the circumferential assembly  1020 . As can be seen in  FIGS. 5B and 5C , the keyed block  1075  is rotated to cause the guide bullet  1070  to advance towards the keyed block  1075 .  FIG. 5C  shows the microcylinder locking mechanism  1050  with the adjustment tool  1060  after adjustment and disengagement of the microcylinder locking mechanism  1050  by the adjustment tool  1060  with a fixed repositioning of the guide bullet  1070  and a distal lengthening of the adjustment member  1025  with respect to the microcylinder  1052 . As the final position of the keyed block  1075  is further away from the microcylinder  1052 , and because the microcylinder  1052  is fixed to the control device  1030  of the circumferential assembly  1020 , this exemplary movement of the adjustment member  1025  indicates that the circumferential assembly  1020  has reduced in diameter. 
         [0082]    Various alternative embodiments of this locking mechanism are envisioned where a number of the individual parts are fixed or moving with respect to other ones of the parts of the circumferential assembly  1020 , the control device  1030 , the locking mechanism  1050 , and/or the adjustment tool  1060 . In one alternative embodiment of the microcylinder locking mechanism  1050 , the collar portion  1065  of the remote adjustment tool  1060  can contains inner striations (similar to or different from the striations  1055  of the microcylinder  1052 ) that allow it to capture and turn the guide bullet  1070  through removable fixation of the tines  1072  therein (see  FIG. 6E ). In such a configuration, the guide bullet  1070  can be fixed rotationally to the adjustment member  1025 . 
         [0083]    The inner striations  1055  of the microcylinder  1052  may be grooves, threads, detents, slots, or other surface features sufficient to allow capture of the tines  1072  upon their release as shown in further detail, for example, in the cross-sections of  FIGS. 6A to 6G .  FIG. 6A  is a cross-section along section line A-A of the microcylinder  1052  and guide bullet  1070  of  FIG. 5A , in which the tines  1072  having an exemplary triagonal cross-sectional shape are caught within two striations  1055  having an exemplary rectangular cross-sectional shape.  FIG. 6B  is a cross-section along section line B-B of the tool sheath  1062  of  FIG. 5A  and illustrates the relatively smooth outer surface of the tool sheath  1062 .  FIG. 6C  is a cross-section along section line C-C of the microcylinder  1052  of  FIG. 5B  without the adjustment member  1025  depicted.  FIG. 6D  is a cross-section along section line D-D of the microcylinder  1052 , the guide bullet  1070 , and the tool sheath  1062  of  FIG. 5B , in which the tool sheath  1062  captures the guide bullet  1070  and collapses the tines  1072 , thereby removing the tines  1072  from the striations  1055  of the microcylinder  1052 . 
         [0084]      FIG. 6E  shows a cross-sectional view of a variation of another exemplary embodiment of the locking mechanism  1050 ′ with the adjustment tool sheath  1062 ′ also having striations  1055 ′ with an exemplary rectangular cross-sectional shape. The tines  1072  are illustrated as expanded within two opposing striations  1055 ′ of the tool sheath  1062 ′. As the tool sheath  1062 ′ has a smooth exterior, the tool sheath  1062 ′ can rotate without friction within the microcylinder  1052 ′. 
         [0085]      FIGS. 6F and 6G  show cross-sectional views of yet another variation of an exemplary embodiment of the microcylinder locking mechanism  1050 ″ and adjustment tool  1060 ″. The locking mechanism  1050 ″ has a microcylinder  1052 ″ with striations  1055 ″ having an exemplary triangular cross-sectional shape. The adjustment tool sheath  1062 ″ has a smooth exterior and interior to slide within the microcylinder  1052 ″ and to slidably capture the tines  1072 ′″, respectively. The tines  1072 ″ are illustrated as expanded within two opposing triangular striations  1055 ″ of the microcylinder  1052 ″ in  FIG. 6F  and are captured within the tool sheath  1062 ″ in  FIG. 6G . 
         [0086]      FIGS. 7A and 7B  show longitudinal cross-sectional details of one exemplary embodiment of a locking mechanism  1110  for the adjustment tool  1035  according to the present invention.  FIG. 7A  shows a locking mechanism  1110  comprising a controllable catch  1115  in a disengaged stated.  FIG. 6B  shows the locking mechanism  1110  with the controllable catch mechanism  1115  engaged. Once the adjustment member catch  1120  is within the target range  1117  of the locking mechanism, the user can engage a non-illustrated catch deployment device to capture the adjustment member catch  1120 . 
         [0087]      FIGS. 8A to 8C  show details of still another embodiment of a microcylinder locking mechanism  1150  according to the present invention, in which internal locking tines  1152 ,  1154  of unequal length are employed to prevent back rotation from torque buildup upon detachment of the remote adjustment tool  1060 .  FIG. 8A  shows the locking mechanism  1150  comprised of a microcylinder  1151  and a guide bullet  1153  with internal locking tines  1152 ,  1154  of unequal length and an associated adjustment tool  1160  having a tool sheath  1164  prior to engagement of the microcylinder locking mechanism  1150  by the tool sheath  1164 .  FIG. 8B  shows the tool sheath  1164  of  FIG. 8A  engaged with the microcylinder locking mechanism  1150  to deflect the tines  1152 ,  1154  away from the interior surface of the microcylinder  1151 .  FIG. 8C  shows the microcylinder locking mechanism  1150  in a locking position different from  FIG. 8A  after adjustment has occurred and the tool sheath  1164  has been disengaged from the microcylinder  1151 . 
         [0088]      FIGS. 9A and 9B  show two aspects of details of sheathable retention tines  1130  and a compressible foam sealing gasket  1140  for the proximal terminal aspect of some exemplary embodiments of endografts according to the present invention.  FIG. 9A  is an axial cross section showing sheathable retention tines  1130  sheathed by an expanded compressible foam gasket  1040  in an exemplary proximal aspect of a sealable endograft system  1000  according to the present invention.  FIG. 9B  is a perspective view showing sheathable retention tines  1130  exposed and deployed through the compressible foam sealing gasket  1140  disposed at an expanded proximal cuff  1010  in an exemplary endograft according to the present invention. In some exemplary embodiments of the present invention, the direct pressure of the adjustment member  1025  on the footplate  1145  of the tines may be used to extend the sheathable tines  1130  through the compressible foam gasket  1040  and into the wall of a recipient blood vessel. In yet other exemplary embodiments of the present invention, direct pressure of the adjustment member  1025  may exert force on non-illustrated footplate bands that may be attached to or adjacent the footplates  1145  of the tines  1130  and may be used to extend the sheathable tines  1130  through the compressible foam gasket  1040  and into the wall of a recipient blood vessel. Such footplate bands may, themselves, be the base of the sheathable tines  1130  in certain exemplary embodiments of the present invention. Not shown in  FIGS. 9A and 9B , the adjustment member  1025  may course though eyelets, other brackets or may otherwise be moveably connected to the footplates  1145  to maintain equal pressure and desired orientation upon expansion of the adjustment member loop. 
         [0089]    In the various embodiments of sealable endograft systems according to the present invention, the distal attachment of the endograft to the aortic wall distal to the aneurysm sac may be accomplished in a conventional manner using an expandable lattice component at the distal cuffs, or variations on the adjustable, sealable mechanism disclosed herein may be employed to secure distal seals. The distal seals are subject to lower pressure demands, and the anatomic constraints of sufficient aortic neck distally are generally less problematic than for the proximal seal. 
         [0090]      FIGS. 10 to 13  provide anatomic views of another exemplary embodiment of an endograft implant according to the present invention in which the implant is a universal proximal cuff endovascular implant for treatment of an abdominal aortic aneurysm. Endografts with the features shown in the various embodiments of the present invention have unique abilities to accommodate to anatomic variations that would preclude or compromise use of conventional endograft systems. The universal proximal cuff implants of the present invention allow an operator to make use of their ability to securely seal and attach in anatomic sites where conventional endografts cannot be securely placed, and then allow a conventional endograft to securely dock with the universal proximal cuff endovascular implants distally. 
         [0091]    Universal proximal cuff endovascular implants of the present invention may be provided with any of the elements disclosed in the present and the incorporated co-pending applications referenced herein. Such elements include, but are not limited to, attachment of radio-opaque monitoring clip assemblies on the outer surfaces of endografts to allow post-implantation monitoring of slippage or endoleak formation by plain radiographs, steerable delivery systems to permit delivery and seal of an endograft in an anatomically angulated or irregular site, and/or auto-accommodation for post-implantation aortic remodeling, 
         [0092]      FIG. 10A  is an axial cross-sectional view of an exemplary endovascular universal interface cuff  1155  of the present invention to be implanted into an aorta having an aneurysm sac  1170  and an aortic wall  1175 . The universal endovascular interface cuff  1155  has been positioned over an endovascular guidewire  1160  to a desired recipient site A-A′ proximal to the aortic aneurysm sac  1170 . The endovascular universal interface cuff  1155  further comprises an accommodating proximal cuff  1010  and a rigid distal cuff  1200 .  FIG. 10B  provides a transverse cross-sectional view of the exemplary endovascular interface cuff  1155  of  FIG. 10A  at the level of A-A′ in  FIG. 10A . In  FIGS. 10A and 10B , the compressible foam gasket  1140  is uncompressed and, therefore, covers the retention tines  1165 . 
         [0093]    In the exemplary embodiment shown in  FIG. 10B , the adjustment member  1025  courses in a circumferential loop through eyelets  1180  attached to a series of compression footplates  1185 . The compression footplates  1185 , among other functions, serve to maintain an orientation of the expanding circumferential loop  1035  in a plane transverse to the aortic lumen  1190 , and present a broader pressure contact with the underlying aortic wall  1175  when the circumferential assembly is expanded. The compression footplates  1185  may abut, be attached to, or be contiguous with the retention tines  1165 , which are displaced through the compressed compressible foam gasket  1140  and allowed to enter the aortic wall  1175  for overall device stabilization and retention. While four retention tines  1165  and footplates  1185  are shown, this embodiment is merely exemplary and can be any number. 
         [0094]      FIG. 11A  shows the same axial cross-sectional view of the endovascular universal interface cuff  1155  of  FIG. 10A  but after the universal endovascular interface cuff  1155  has expanded to achieve a seal in the aortic wall  1175 . Due to the expansion of the cuff, the foam gasket  1140  becomes compressed, allowing the retention tines  1165  to protrude radially outward to engage the aortic wall  1175  in the desired recipient site A-A′ proximal to the aortic aneurysm sac  1170 . In the exemplary embodiment shown in  FIG. 11B , the adjustment member  1025  has expanded to move the eyelets  1180  attached to the footplates  1185  outwards. As is evident, the interior lumen of the circumferential assembly  1020  shown in  FIG. 11B  has increased substantially as compared to the state shown in  FIG. 10B . In  FIG. 11B , the compression of the foam gasket  1140  and the engagement of the aortic wall  1175  by the retention tines  1165  creates a firm seal between the universal endovascular interface cuff  1155  and the aortic wall  1175 . 
         [0095]      FIG. 12  shows the same axial cross-sectional axial of the universal endovascular interface cuff  1155  of the present invention as in  FIGS. 10A and 11A  but with delivery of a conventional endograft  1300  into the aortic wall  1175 , which endograft  1300  has been secured within the rigid distal cuff  1200  of the universal endovascular interface cuff  1155 . The endograft  1300  can include an expandable lattice  1310 .  FIG. 13  shows the same cross-sectional axial view of an exemplary universal endovascular interface cuff  1155  of the present invention as  FIG. 12  but after removal of the endovascular guidewire  1160  and detachment and removal of the adjustment member  1025 . Such removal and detachment can be carried out by a release mechanism  1037 . The distal attachment of the conventional endograft is not shown in  FIGS. 12 and 13 , but can be accomplished in the usual manner for conventional endograft implantation sufficient to prevent backfill of the aneurysm sac  1170  from the distal aorta or the iliac vessels. 
         [0096]    As shown in  FIGS. 10A, 11A, 12, and 13 , the rigid distal cuff  1200  includes, at its exterior, exemplary radio-opaque monitoring clip assemblies  1225  to allow post-implantation monitoring of slippage or endoleak formation and/or auto-accommodation for post-implantation aortic remodeling. Likewise, the rigid distal cuff  1200  can be provided with interior graft retention tines  1227  that add to securing, without leaks, the endograft  1300  to the interior of the rigid distal cuff  1200 . 
         [0097]    The tubular endograft body  1005 , the proximal cuff  1010 , the rigid distal cuffs  1200 , and the endograft body  1300  as described herein may be constructed of solid, woven, non-woven, or mesh materials such as, but not limited to, natural or synthetic rubbers, nylon, GORE-TEX®, elastomers, polyisoprenes, polyphosphazenes, polyurethanes, vinyl plastisols, acrylic polyesters, polyvinylpyrrolidone-polyurethane interpolymers, butadiene rubbers, styrene-butadiene rubbers, rubber lattices, DACRON®, PTFE, malleable metals, other biologically compatible materials or a combination of such biologically compatible materials in a molded, woven, or non-woven configuration, coated, non-coated, and other polymers or materials with suitable resilience and pliability qualities. In certain exemplary embodiments according to the present invention, it is desirable for the non-elastic tubular member  1015  and corresponding structures to be pliable to allow for folding or compressibility without allowing elasticity. In certain exemplary embodiments according to the present invention, it is desirable for the accommodating proximal cuff  1010  and corresponding structures to have plasticity and be compressible or foldable. In any given exemplary embodiment, the non-elastic tubular implant body  1015 , the endograft body  1300 , the accommodating proximal cuff  1010 , and corresponding structures may be constructed of the same material of varying elasticity, or these structures may be constructed of different, but compatible materials. 
         [0098]    The adjustment members  1025 , the retention tines  1130 ,  1165 , and the microcylinders  1030  and other mechanical components as disclosed herein and in all other embodiments of the present invention may be fabricated of any suitably strong biocompatible material, including, but not limited to titanium, stainless steel, cobalt chromium alloys, other metals, other metal alloys, nitinol, plastics, or ceramics. Similarly, the adjustment members  1025 , the retention tines  1130 ,  1165 , and the microcylinders  1030  and other mechanical components may be milled, laser cut, lathed, molded, or extruded. 
         [0099]    The compressible foam gaskets  1140  as disclosed herein may be any biocompatible foam material of either an open or closed cell structure with sufficient compressibility and resilience to allow rapid recovery in a non-compressed state. In various exemplary embodiments according to the present invention, such foam materials may be viscoelastic foam with a compressible cellular material that has both elastic (spring-like) and viscous (time-dependent) properties. Viscoelastic foam differs from regular foam by having time-dependent behaviors such as creep, stress relaxation, and hysteresis. 
         [0100]      FIGS. 14A and 14B  show an alternate exemplary embodiment of a sealable endograft system  2000  according to the present invention in two different states. In the view of  FIG. 14A , a hinged lattice structure  2100  is attached to an internal or external surface of at least the proximal portion  2210  of an endograft body  2200  (the “lattice” in these figures is only diagrammatic and is not intended to imply that the only possible number of rings of lattice is greater than one). Either the lattice structure  2100  or the endograft body  2200  can be provided with radially displaced retention tines  2105  that, in a non-distended state of the proximal portion  2210 , can be covered within a compressible foam gasket  2300 . In the embodiment shown in  FIG. 14A , the distal portion  2220  of the endograft body  2200  comprises a non-distensible material and the proximal portion  2210  of the endograft body  2200  is an accommodating cuff comprising a distensible material forming the proximally terminal aspect of the sealable endograft system  2000  and enclosing the terminal hinged lattice structure  2100  therewithin. 
         [0101]    A control system  2400  or jack screw shown in  FIGS. 14A and 14B  is provided to expand and contract the lattice structure  2100 . In particular, a torque wire  2410  can be fixed at two points  2420 ,  2430  longitudinally separate from one another on the lattice structure  2100 . This torque wire  2410  has exterior threads that correspond to threaded bores of one of the two points  2420 ,  2430 . Accordingly, when the torque wire  2410  is rotated, the two points  2420 ,  2430  of the lattice either approach one another (to expand the proximal portion  2210 ) or retreat from one another (to contract the proximal portion  2210 ) this imparts motion to all contiguously interconnected lattice elements. It is preferred to have the proximal end point  2430  be bored for rotation but fixed longitudinally. In this case, a smooth-bored collar  2440  is fixed to the wall of the graft  2200 , for example, on an interior surface distal of the lattice structure  2100 . When the adjustment tool  1035  is rotated, the torque wire  2410  correspondingly rotates to expand or contract the proximal portion  2210  of the endograft  2200 . In this manner, in comparison to self-expanding prior art stent structures (e.g., made of nitinol) passively open to their greatest extent when relieved from radially inward compression, the lattice structure of the present invention is able to actively open according to the desire of the user surgeon implanting the prosthesis. As such, the opening performed by prior art self-expanding stent structures in endograft prosthesis are referred to herein as “passive opening” or “passive expansion”. In contrast thereto, the expansion performed by the inventive controllable, hinged, lattice structure of the present invention for the disclosed endograft prostheses is referred to herein as “active control” or “active expansion” because it can be actively controlled in both the expansion and contraction directions according to the desire of the user. This is further in contrast to expansion of stent structures using balloon, which case is referred to as “balloon opening” or “balloon expansion” because it occurs only in one direction (expansion) without any ability to contract actively. The single embodiment of the jack screw shown in  FIGS. 14A and 14B  can be replicated any number of times about the circumference of the lattice structure  2100   
         [0102]    In a non-illustrated alternative to the configuration of the system shown in  FIG. 14B , the configuration shown in  FIGS. 10A to 11B  can be incorporated into the system of  FIGS. 14A and 14B  to create a hybrid system. The circumferential assembly  1020  can be positioned at the proximal end of the endograft and action of the circumferential loop  1035  within the proximal cuff  1010 , can be used to expand and contract the latticework  2100 . 
         [0103]      FIG. 15A  is a lateral view of an exemplary embodiment of an adjustable vascular cannula  1230  according to the present invention. As shown in  FIG. 15A , such an adjustable vascular cannula  1230  is a generally tubular structure with external cannula walls  1235  defining a cannula lumen  1240 , and comprises a port end  1245 , a cannula body  1250 , and a cannula tip  1255 . As further shown in  FIG. 15A , the cannula body  1250  is further provided with a delivery recess  1260  in its external wall structure at or near the junction of the cannula tip  1255 . Further still, the adjustable vascular cannula  1230  of  FIG. 15A  comprises an adjustable seal device  1265  attached to an adjustment member  1025  such as a torque wire that extends beyond the port end  1245  of the adjustable vascular cannula  1230  as shown in  FIG. 15B . The adjustment member  1025  may course through the cannula lumen  1240 , or it may course through an accessory lumen (not shown in  FIGS. 15A or 15B ) within the cannula wall  1235  substantially parallel to the cannula lumen  1240 , or it may course externally to the adjustable vascular cannula  1230  as shown partially within and partially outside the lumen  1240  in  FIG. 15B . When in a non-deployed state, as shown in  FIG. 15B , the adjustable seal device  1265  is substantially flush with the outer diameter of the cannula walls  1235  within the delivery recess  1260  of the cannula body  1250 . 
         [0104]      FIG. 15C  shows the adjustable seal device  1265  in a deployed state, which is the result of torque applied externally to the adjustment member  1025  by a user. As shown in  FIG. 15C , the adjustable seal device  1265  further comprises a hinged adjustable latticework  1270  covered by a sealing cuff  1275  which is constructed of a distensible material. The adjustment member  1025  terminates, for example, in a circumferential loop  1035  within the sealing cuff  1275 , where it may be further covered by a compressible foam gasket  1140 . The adjustment member  1025  may further pass through a locking mechanism  1050  as disclosed elsewhere herein which serves to regulate the torque applied to the circumferential loop  1035 . The hinged adjustable latticework  1270  may further be provided with one or more retention tines  1130 ,  1165 , which are radially displaced from the terminal aspect of the hinged adjustable latticework  1270 , and which are enclosed within and covered by the compressible foam gasket  1140  when the adjustable seal device  1265  is not distended. When torque is applied to the adjustment member  1025  by a user, the diameter of the circumferential loop  1035  is increased, displacing the hinged adjustable latticework  1270  as shown in  FIG. 15C  until the compressible foam gasket  1140  and the sealing cuff  1275  is able to firmly engage the inner wall  1190  of a recipient blood vessel  1175 . A slight additional amount of torque applied to the adjustment member  1025  is, then, sufficient to compress the compressible foam gasket  1140  and allow the retention tines  1130 ,  1165  to engage the wall  1190  of the recipient blood vessel  1175 , thus preventing slippage of the cannula during use. In various exemplary embodiments of the present invention, the retention tines  1130 ,  1165  may be provided to engage the vessel wall  1190  in a substantially straight manner or at angles varying from about 1 degree to about 179 degrees. The retention tines  1130 ,  1165  may be angled axially or longitudinally in various embodiments according to the present invention. After the use of the cannula is completed, the torque of the adjustment member  1025  may be reversed, collapsing the adjustable seal device  1165 , and allowing the compressible foam gasket  1140  to re-expand, thus withdrawing the retention tines  1165  from the vessel wall  1175  and covering the retention tines  1165  to allow atraumatic cannula withdrawal. 
         [0105]    Although the foregoing embodiments of the present invention have been described in some detail by way of illustration and example for purposes of clarity and understanding, it will be apparent to those skilled in the art that certain changes and modifications may be practiced within the spirit and scope of the present invention. Therefore, the description and examples presented herein should not be construed to limit the scope of the present invention, the features of which are set forth in the appended claims. 
         [0106]    The foregoing description and accompanying drawings illustrate the principles, exemplary embodiments, and modes of operation of the invention. However, the invention should not be construed as being limited to the particular embodiments discussed above. Additional variations of the embodiments discussed above will be appreciated by those skilled in the art and the above-described embodiments should be regarded as illustrative rather than restrictive. Accordingly, it should be appreciated that variations to those embodiments can be made by those skilled in the art without departing from the scope of the invention as defined by the following claims.