Patent Publication Number: US-2023149003-A1

Title: Cardiac and Vascular Access and Closure System and Method

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     The present application is related to and claims priority to U.S. Provisional Patent Application Serial Nos. 63/272,938, filed Oct. 28, 2021, and 63/298,980, filed Jan. 12, 2022; and is a continuation-in-part of co-pending U.S. patent application Ser. No. 17/466,619, filed Sep. 3, 2021, which is a continuation of U.S. patent application Ser. No. 17/173,914, filed Feb. 11, 2021, now U.S. Pat. No. 11,123,542 issued Sep. 21, 2021. 
    
    
     BACKGROUND OF THE INVENTION 
     The present invention pertains generally to devices, systems and methods for cardiac and vascular access. More particularly, the present disclosure pertains to devices, systems and methods for transcardiac access. Still more particularly, the present disclosure pertains to use of the system, devices and methods of the present disclosure as ports for transcardiac access to the internal cardiac anatomy. Further, the present disclosure pertains to catheters and cannulas for transcardiac placement, access, perfusion, or exchange. 
     The present disclosure also pertains to devices, systems and methods for extra-corporeal membrane oxygenation (ECMO) veno-venous (VV) access (VV-ECMO). Still more particularly, the present disclosure pertains to use of the system, devices and methods of the present disclosure as a right ventricular assist device (RVAD) in patients with right heart failure who have adequate lung function. Further the devices, system and methods of the present disclosure are capable of use as a left ventricular assist device (LVAD) as well. 
     ECMO is a form of heart-lung machine that may be is useful to treat severe acute respiratory failure (ARF) when conventional ventilator management is inadequate or even injurious to lung health and potential survival. ECMO machines consist, generally, of tubing, a blood pump and an oxygenator. Patients with respiratory failure due to inflammatory diseases and infectious diseases have potentially reversible disease provided support can be maintained for an adequate time. Patients with chronic and or irreversible lung failure may be supported with ECMO as a bridge to lung transplant. VV-ECMO preserves cardiovascular function by withdrawing blood from the systemic venous circulation, i.e., outflow from the body to the ECMO machine where the blood is oxygenated and carbon dioxide is removed. The blood is then re-infused, i.e., inflow to the body from the ECMO machine, to the venous circulation proximal to the lung parenchyma, and typically into the right atrium. 
     ARF/ECMO requires large bore venous access via one or more percutaneous cannulas. Conventionally, one or more cannulas are placed via the right internal jugular vein, a femoral vein or both. In some cases concomitant pulmonary hypertension impairs right ventricular function necessitating right ventricular support. In this circumstance, return flow right ventricular dysfunction can be managed by returning the blood directly to the pulmonary artery. Current cannula technology limits the duration that ECMO support can be accomplished due to complications at the cannula entry sites and obligatory patient mobility limitations. In addition, many VV-ECMO cannulation strategies can be limited by recirculation where oxygenated blood from the inflow source is withdrawn from the outflow source before it can transit the pulmonary circulation. This results in inefficient or inadequate oxygen delivery to the systemic circulation. 
     Velour-wrapped paracorporeal cannulas which are intended for medium to long-term use as right and left ventricular assist devices, i.e., RVAD and/LVAD, respectively, transit the abdominal wall to a cardiac chambers or great vessel. In the clinical setting, para-corporeal Berlin Heart EXCOR (Berlin Heart, The Woodlands, Tex.) cannulas were successfully deployed to the right atrium and pulmonary artery for long-term, i.e., greater than 5 months, for ECMO support in patients with infectious ARF. This strategy facilitated aggressive mobilization and rehabilitation. Such a strategy, however, requires full median sternotomy and cardiopulmonary bypass for both insertion and removal of the Berlin Heart EXCOR cannulas. The Berlin Heart EXCOR cannulas are only approved for pediatric sales and use in the United States. 
     SUMMARY OF THE INVENTION 
     It is an objective of the present disclosure to provide a system for trans-cardiac or intravascular access and closure. 
     It is a further objective of the present disclosure to provide an access cuff device for trans-cardiac access and closure. 
     It is another objective of the present invention to provide an access cuff comprising a compression assembly for attaching the access cuff to the heart muscle. The compression assembly includes an annular member having a plurality of tissue anchor openings passing there through and at least one attachment skirt configured to be positioned between the annular member and the heart muscle and which allows tissue anchors to pass through the attachment skirt, axially compress the annular member and the attachment skirt to the heart muscle in a hemostatic manner. 
     It is a further objective of the present disclosure that the annular member be a unitary or segmented compression ring. 
     It is still another objective of the present disclosure that the access cuff further includes an access cap configured to removably engage with the annular member, wherein the access cap has a central opening and comprises a seal or valve that allows a catheter, cannula, ventricular assist device, surgical instruments, and/or implantable devices to pass into and through the central opening of the access cap and through the access cuff in a hemostatic manner. 
     It is still a further objective of the present disclosure to provide a method for establishing transabdominal or transthoracic cardiac or vascular access to conduct procedures within the heart, arterial valves, or vasculature. 
     It is still yet another objective of the present disclosure to provide a transabdominal or transthoracic multi-lumen cannula for access through the cardiac wall or vascular wall and is configured to pass into and through the access cuff. 
     It is still a further objective of the present disclosure to provide a tubular graft coupled to the access cuff that is configured to function as a working channel through a central annular opening of the access cuff and permit a catheter, cannula, or other instrumentation to pass into and through tubular graft and central annular opening of the access cuff and into the heart. 
     It is yet a further objective of the present disclosure to provide a securing collar that secures the tubular graft, cannula, and access cuff together in a hemostatic manner and is removable to allow withdrawal of the cannula from the access cuff. 
     It is yet another objective of the present disclosure to provide a closure device configured to be used with the access cuff after the cannula is withdrawn from the access cuff. 
     It is still a further objective of the present disclosure to provide a paracorporeal cannula useful with the access cuff to access a ventricular or atrial chamber or transit a cardiac valve. 
     It is still another objective of the present invention to provide a paracorporeal catheter having plural lumens configured for blood perfusion both from the heart and returned to the heart after transiting an ECMO machine. 
     It is yet another objective of the present disclosure to provide a closure device configured to be used with the access cuff. 
     It is still a further objective of the present disclosure to provide a system including the access cuff device, the paracorporeal catheter, and the closure device. 
     It is yet a further objective of the present disclosure to provide a method of delivering the access cuff and paracorporeal cannula, conducting VV-ECMO, removing the paracorporeal cannula, and closing the access through the ventricular access cuff with the closure device. 
     It is still another objective of the present disclosure to provide an assist method for right ventricular assist or left ventricular assist using the access cuff device and the hemostatic plug or cap as disclosed. 
    
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
         FIG.  1    is a perspective view of an access cuff in accordance with the present disclosure. 
         FIG.  2    is a perspective partially exploded view of the access cuff with engaged tissue anchors and an access cap in accordance with the present disclosure. 
         FIG.  3    is a perspective view of the access cuff engaged with the access cap in accordance with the present disclosure. 
         FIG.  4    is a perspective cross-sectional view of the access cuff and its engagement with the access cap and showing an attachment skirt associated with the access cuff in accordance with the present disclosure. 
         FIG.  5    is a is a diagrammatic view illustrating attachment of the access cuff to cardiac muscle tissue illustrating a access cuff delivery device holding the access cuff. 
         FIG.  6    is a diagrammatic view illustrating the access cuff affixed to the cardiac muscle tissue. 
         FIG.  7    is a diagrammatic view illustrating a multi-lumen perfusion cannula passing through the access cap in accordance with the present disclosure. 
         FIG.  8    is a diagrammatic view illustrating passing the dual lumen perfusion cannula into and through the access cuff and engagement of the access cap with the access cuff as well as blood inflow and outflow through the dual lumen perfusion cannula and into the heart right atrium and right ventricle, respectfully. 
         FIG.  9    is a diagrammatic view illustrating engagement of a hemostatic plug of cap after withdrawal of the dual lumen perfusion catheter and catheter cap associated therewith. 
         FIG.  10    is a perspective view of an alternative variant of an assembled access cuff in accordance with the present disclosure. 
         FIG.  11    is a side-elevational, cross-sectional view of the alternative variant of the assembled access cuff in accordance with the present disclosure. 
         FIG.  12    is a perspective, partial cut-away view of the alternative variant of the assembled access cuff in accordance with the present disclosure. 
         FIG.  13    is a perspective exploded view of the alternative variant of the access cuff in accordance with the present disclosure. 
         FIG.  14    is a perspective view of the alternative variant of the access cuff of the present disclosure, an access cannula, and a retaining collar in accordance with the present disclosure. 
         FIG.  15    is a perspective view of the alternative variant of the access cuff having the flanged graft portion ligated and sealed in accordance with the method of the present disclosure. 
         FIG.  16    is a perspective view of the alternative variant of the access cuff of the present disclosure, an access cannula, and an alternative retaining collar in accordance with the present disclosure. 
         FIG.  17    is a perspective view of the alternative variant of the access cuff having the flanged graft portion ligated and sealed in accordance with the method of the present disclosure. 
         FIG.  18    is a side elevational view of a cannula configured for transabdominal or transthoracic access through the access cuff of the present disclosure. 
         FIG.  19    is a diagrammatic cross-sectional view taken along line A-A of  FIG.  18   . 
         FIG.  20    is a partially exploded view illustrating transabdominal or transthoracic access through the alternative variant of the access cuff and attachment of a retaining collar in accordance with the present disclosure. 
         FIG.  21    is a diagrammatic view illustrating attachment of the alternative variant of the access cuff, retaining collar and cannula joined to epicardium of the heart muscle. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     The device, system and methods of the present invention will be described with reference to certain exemplary embodiments thereof. These exemplary embodiments or variants are intended to be illustrative and non-limiting examples of the present invention. The example embodiments are provided so that this disclosure will be thorough, and will fully convey the scope to those who are skilled in the art. Numerous specific details are set forth such as examples of specific components, devices, and methods, to provide a thorough understanding of embodiments of the present disclosure. It will be apparent to those skilled in the art that specific details need not be employed, that example embodiments or variants may be embodied in many different forms and that neither should be construed to limit the scope of the disclosure. Those of ordinary skill in the art will understand and appreciate that variations in materials, structure, material properties, and tolerances may be made without departing from the scope of the invention, which is defined only by the claims appended hereto and their range of equivalents. In some example embodiments, well-known processes, well-known device structures, and well-known technologies are not described in detail. 
     Benefits, other advantages, and solutions to problems have been described herein with regard to specific embodiments or variants. Furthermore, the connecting lines shown in the various figures contained herein are intended to represent exemplary functional relationships and/or physical couplings between the various elements. It should be noted that many alternative or additional functional relationships or physical connections may be present in a practical system. However, the benefits, advantages, solutions to problems, and any elements that may cause any benefit, advantage, or solution to occur or become more pronounced are not to be construed as critical, required, or essential features or elements of the disclosure. 
     The scope of the disclosure is accordingly to be limited by nothing other than the appended claims, in which reference to an element in the singular is not intended to mean “one and only one” unless explicitly so stated, but rather “one or more.” It is to be understood that unless specifically stated otherwise, references to “a,” “an,” and/or “the” may include one or more than one and that reference to an item in the singular may also include the item in the plural. All ranges and ratio limits disclosed herein may be combined. 
     Moreover, where a phrase similar to “at least one of A, B, and C” is used in the claims where A, B, and C refer to claimed elements, it is intended that the phrase be interpreted to mean that A alone may be present in an embodiment, B alone may be present in an embodiment, C alone may be present in an embodiment, or that any combination of the elements A, B and C may be present in a single embodiment; for example, A and B, A and C, B and C, or A and B and C. Different cross-hatching when used throughout the figures to denote different parts but not necessarily to denote the same or different materials. 
     For ease of understanding, the present invention is described with reference to the accompanying Figures. In the accompanying Figures like elements are identified by like reference numerals. 
     The terminology used herein is for the purpose of describing particular example embodiments only and is not intended to be limiting. As used herein, the singular forms “a,” “an,” and “the” may be intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms “comprises,” “comprising,” “including,” and “having,” are inclusive and therefore specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the particular order discussed or illustrated, unless specifically identified as an order of performance. It is also to be understood that additional or alternative steps may be employed. 
     When an element or layer is referred to as being “on,” “engaged to,” “connected to,” or “coupled to” another element or layer, it may be directly on, engaged, connected or coupled to the other element or layer, or intervening elements or layers may be present. In contrast, when an element is referred to as being “directly on,” “directly engaged to,” “directly connected to,” or “directly coupled to” another element or layer, there may be no intervening elements or layers present. Other words used to describe the relationship between elements should be interpreted in a like fashion (e.g., “between” versus “directly between,” “adjacent” versus “directly adjacent,” etc.). As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items. 
     Although the terms first, second, third, etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be limited by these terms. These terms may be only used to distinguish one element, component, region, layer or section from another region, layer or section. Terms such as “first,” “second,” and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the example embodiments. 
     Spatially relative terms, such as “inner,” “outer,” “beneath,” “below,” “lower,” “above,” “upper,” and the like, may be used herein for ease of description to describe one element or feature&#39;s relationship to another element(s)&lt;r feature(s) as illustrated in the figures. Spatially relative terms may be intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as “below”, or “beneath” other elements or features would then be oriented “above” the other elements or features. Thus, the example term “below” can encompass both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. 
     “Substantially” is intended to mean a quantity, property, or value that is present to a great or significant extent and less than and including totally. 
     “About” is intended to mean a quantity, property, or value that is present at ±10%. Throughout this disclosure, the numerical values represent approximate measures or limits to ranges to encompass minor deviations from the given values and embodiments having about the value mentioned as well as those having exactly the value mentioned. Other than in the working examples provided at the end of the detailed description, all numerical values of parameters (e.g., of quantities or conditions) in this specification, including the appended claims, are to be understood as being modified in all instances by the term “about” whether or not “about” actually appears before the numerical value. “About” indicates that the stated numerical value allows some slight imprecision with some approach to exactness in the value; approximately or reasonably close to the value; nearly. If the imprecision provided by “about” is not otherwise understood in the art with this ordinary meaning, then “about” as used herein indicates at least variations that may arise from ordinary methods of measuring and using such parameters. In addition, disclosure of ranges includes disclosure of all values and further divided ranges within the entire range, including endpoints given for the ranges. 
     “Transabdominal” is intended to mean passing across the abdominal wall and/or abdominal cavity. 
     “Transcardiac” is intended to mean passing across the cardiac wall. 
     “Transthoracic” is intended to mean passing across the chest and/or the thoracic cavity. 
     Medical or anatomical terms are intended to have their usual and customary meaning in the medial arts and terminology. 
     The steps recited in any of the method or process descriptions may be executed in any order and are not necessarily limited to the order presented. Furthermore, any reference to singular includes plural embodiments, and any reference to more than one component or step may include a singular embodiment or step. Elements and steps in the figures are illustrated for simplicity and clarity and have not necessarily been rendered according to any particular sequence. For example, steps that may be performed concurrently or in different order are illustrated in the figures to help to improve understanding of embodiments of the present disclosure. 
     Any reference to attached, fixed, connected or the like may include permanent, removable, temporary, partial, full and/or any other possible attachment option. Additionally, any reference to without contact (or similar phrases) may also include reduced contact or minimal contact. Surface shading lines may be used throughout the figures to denote different parts or areas but not necessarily to denote the same or different materials. In some cases, reference coordinates may be specific to each figure. 
     Systems, methods, and apparatus are provided herein. In the detailed description herein, references to “one embodiment,” “an embodiment,” “various embodiments,” etc., indicate that the embodiment described may include a particular feature, structure, or characteristic, but every embodiment may not necessarily include the particular feature, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same embodiment. Further, when a particular feature, structure, or characteristic is described in connection with an embodiment, it is submitted that it is within the knowledge of one skilled in the art to affect such feature, structure, or characteristic in connection with other embodiments whether or not explicitly described. 
     Furthermore, no element, component, or method step in the present disclosure is intended to be dedicated to the public regardless of whether the element, component, or method step is explicitly recited in the claims. No claim element is intended to invoke 35 U.S.C. 112(f) unless the element is expressly recited using the phrase “means for.” 
     As used herein, 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. 
     The system  45  of the present disclosure consist generally of several component devices, namely, an access cuff  10  shown in  FIG.  1    and  FIG.  2   , a medical device  150 , depicted for reference purposes only as paracorporeal dual lumen perfusion cannula, shown in  FIG.  7   , an access cap  30  shown in  FIGS.  2 ,  3  and  4   , and a hemostatic plug or cap  54  shown in  FIG.  9   . The access cuff serves as a trans-cardiac access site for the dual lumen perfusion cannula. The access cuff  10  is configured for placement on an epicardial surface of a heart  5 , such as the left or right ventricle, and allow access through the cardiac muscle tissue and into the ventricular space to allow passage of the medical device  150 , e.g., a dual lumen perfusion cannula, through the access cuff, into the cardiac ventricle and, in the case of the perfusion cannula, extend past the associated arterial valve into the distal associated artery. 
     The access cuff  10  as shown in  FIGS.  1 ,  2 ,  3  and  4    is configured for placement onto the epicardial surface through a minimal access incision, such as a subxyphoid epigastric incision or limited thoracotomy. The access cuff  10  is comprised of an annular member  12 , having a central bore opening  14 , a plurality of tissue anchor apertures  16  passing axially through a flange  18  concentrically surrounding the central bore opening  14 , and an attachment skirt  24  having a central opening axially aligned with the central bore opening  14  of the annular member  12 . 
     The annular member  12  has an outer circumferential edge  22  having a circumferential projection  20  projecting axially therefrom and defining an outward aspect of flange  18 . The circumferential projection  20  is configured to have a mating attachment  21  that couples to a corresponding mating surface  36  of the access cap  30 . The mating attachment  21  and mating surface  36  may take a wide variety of configurations, including, without limitation, friction fit, interference fit, threaded fit, interlocking fit, bayonet fit, press-fit, or the like. 
     The attachment skirt  24  has a first surface that is positioned to abut flange  18  on a heart-facing surface thereof. A second surface of attachment skirt is positioned to abut the cardia tissue  5 . The attachment skirt  24  facilitates hemostasis with surgical attachment to a cardiac surface  5  and may be comprised of a flexible or rigid felt material, such as polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), or similar non-woven or woven material suitable for creating a hemostatic seal. The attachment skirt  24  has a plurality of tissue anchor receiving sites arrayed about a circumferential aspect of the attachment skirt and is configured to allow for tissue anchors to penetrate into and through the attachment skirt  24  without substantial bleeding. 
     Tissue anchors  40  engage perpendicularly into and through the tissue anchor receiving sites on the attachment skirt and are deployed either individually, in groups, or simultaneously to couple the access cuff to the ventricular surface. The tissue anchors and attachment skirt exert an axially compressive force to secure the access cuff to the epicardial surface of the ventricle with hemostasis. Optionally, the access cuff has a central cylinder defining the central bore opening. 
     While the tissue anchors shown in the accompanying Figures are helical coil tissue screws, it will be understood that alternative tissue anchors, including, for example, sutures, barbs, pins, or the like, are also useful as tissue anchors in the present disclosure. 
     The access cuff  10 , tissue anchors  40 , and attachment skirt  24  are conceptually similar to the apical cuff attachment system disclosed in commonly owned U.S. Pat. No. 11,123,542 and co-pending, commonly owned U.S. patent application Ser. No. 17/466,619, filed Sep. 2, 2021, which are hereby incorporated by reference in their entirety. 
     The access cap  30 , as shown in  FIGS.  2 ,  3  and  4   , is fixedly or detachably coupled to the access cuff  10 . The access cap  30  has a first annular member  31 configured to mate with the access cuff  10  by engaging the circumferential projection  20  of access cuff  10 . To facilitate a hemostatic engagement there between, first annular member may have a mating surface  36  which cooperates with mating attachment  21  of the access cuff  10 . A second annular member  32  engages with the first annular member  31  and serves to retain a seal  34  centrally positioned within the central annular opening formed by axial alignment of first annular member  31  and the second annular member  21 . Access cap  30  has a central opening  34  configured to allow the medical device  150  to pass through the access cap  30  by passing through the second annular member  32 , the seal  34 , which seals against the medical device  150 , then passing through the first annular member  31  and into and through the access cuff  10  and into the heart  5 . Seal  34  is centrally positioned in the access cap  30  that is configured to bear against an outer wall surface of the medical device  15  and both allow the medical device  150  to be axially adjusted through the seal  34  and provide a hemostatic seal around the outer wall surface of the medical device  150  once it is in a desired position. Seal  34  may be a circumferential seal such as a Tuohy-Borst valve or an O-ring seal, or may be a one-way valve such as dome valve, a duck-bill, or multi-cuspid valve seal. 
     Following patient recovery or transplant, the access cuff is configured accept and secure a hemostatic plug that can be inserted via repeat minimally invasive exposure and coupled to the access cuff to provide a hemostatic seal of the central opening of the access cuff. The access cuff is capable of being produced in a wide variety of sizes and central opening diameters to accommodate a range of cannula and patient sizes. 
     The medical device  150 , shown for example as a paracorporeal dual lumen perfusion cannula useful with the present system is thin-walled and reinforced for kink resistance. Other examples of medical devices  150  which may be used with the access cuff system  45  of the present disclosure include, for example, catheters, cannulas, ventricular assist devices, medical or surgical instruments, endoscopes, implantable devices, conduits, or the like. 
     For purposes of non-limiting example only and without intent limit the use of system  45  to ECMO procedures, reference is being made with illustration to a multi-lumen perfusion cannulas used in ECMO procedures as medical device  150 . An example of an ECMO cannula suitable for use as a medical device with the present system is the PROTEK DUO cannula (LivaNova, Arvada, Colo.) described in U.S. Pat. Nos. 10,279,101, 9,782,534, or 9,168,352, each of which are hereby incorporated by reference. 
     As shown in  FIG.  18   , in perfusion cannula  150 , a first lumen  156  functions as the blood outflow lumen to communicate blood from the patient to the ECMO machine. A second lumen  157  functions as the blood return lumen to return oxygenated blood from the ECMO machine to the patient. Inflow openings  153  communicate with first lumen  156  and are positioned at a distal end  160  of the cannula  160  and transit the cardiac valve  162 . The distal end  160  of the cannula  150  is tapered such that it is smaller in diameter than more proximal portions  152  of the cannula  150 . Inflow openings  153  may alternatively be positioned at the distal end  160  of the cannula  150  and open axially and/or inflow openings  153  may pass through side wall surfaces of the distal end  160  of the cannula  150  and open generally perpendicular to the longitudinal axis of the cannula  150 . The inflow openings  153  are radiographically identifiable and positioned on the distal end of the cannula to sit distal to the cardiac valve  162 . 
     Proximal to the distal end  160  of the cannula  160 , both the inflow or second lumen  157  and outflow or first lumen  156  are present within the cannula  150 . Cannula  150  is characterized by having a tapered increase in cannula diameter to accommodate the inflow  157  and outflow 156 lumens. The largest cannula diameter is positioned at the position of the outflow lumen  156 . At no point do the inflow lumen  157  and outflow lumen  156  communicate blood flow with each other, rather the blood inflow and blood outflow conduits remain separate from each other. The outflow lumen  156  has a section with multiple outflow apertures  151  that permit blood to flow out of the outflow lumen  156 , through the outflow apertures  151  and into the ventricular chamber. The outflow apertures  151  are radiographically identifiable. 
     The portion of the cannula  150  that is secured by the access cuff  10  is configured to permit secure fixation of the cannula  150  without kinking or damage to the outer cannula wall or to the inflow and outflow lumens. The intra-corporeal portion of the cannula  150 , i.e., that part of the cannula between the access cuff  10  and the patient&#39;s skin where the cannula  150  exits the abdominal wall, may be coated or wrapped with a covering  164  that promotes tissue fixation, such as a velour wrap, and reduce the risk of ascending infection along the cannula course. The portion of the cannula external to the skin is intended to accommodate a fixation mechanism  166  to secure the cannula  150  to the body without cannula kinks. At the proximal most aspect of the cannula  150 , the inflow and outflow lumens bifurcate  158  with each lumen forming a larger diameter clampable segment that terminates in an integrated tubing connector intended for connection to ECMO circuit tubing. Each tubing connector accommodates a removable and/replaceable plug to control hemostasis during placement. The inflow lumen plug also accommodates a wire for Seldinger placement of the cannula. The entire length of the cannula  150  is radiopaque. 
     A hemostatic plug or cap  54 , shown in  FIG.  9   , is provided that operably engages with the access cuff  10  after the medical device  150  and access cap  30  have been removed from the patient. Hemostatic plug or cap  54  provides a hemostatic seal of the central opening  14  of the access cuff  10 . The hemostatic plug  54  maintains hemostasis as the patients are weaned from support following recover or transplant to eliminate the need to remove the access cuff  10  from the heart  5 . This approach minimizes bleeding risk and greatly facilitates medical device  150  removal via a limited incision. In use, the hemostatic cap or plug  54  is rapidly inserted and securely fixed to the access cuff  10  to occupy and occlude the central opening  14  of the access cuff that was previously occupied by the medical device  150 . 
       FIGS.  5  to  9    illustrate the method  50  of delivering and using the system  45 . In use, the access cuff  10  is delivered, such as by use of a delivery tool  7  that allows for simultaneous driving of the tissue anchors  40 . Delivery tool  7  is disclosed in co-pending and commonly assigned U.S. patent application Ser. No. 17/351,082, filed Jun. 17, 2021, which is hereby incorporated by reference in its entirety. As illustrated in  FIG.  5   , the access cuff  10  is placed against the epicardial surface of the heart  5 , and the tissue anchors  40  are driven, either synchronously or individually, into the cardiac tissue  5  to secure the access cuff  10  to the heart tissue and cause the attachment skirt  34  to bear against the cardiac tissue  5  with an axially compressive force to the access cuff  10 . The delivery tool  7  illustrated in  FIG.  5    may be used to drive the tissue anchors  40  synchronously and then the individual tissue anchors may be adjusted manually. As noted above, the tissue anchors  40  may be helical coil tissue screws, barbs, sutures, or the like. 
     As illustrated in  FIG.  6   , once the delivery tool  7  has been used to secure the access cuff  10  to the cardiac tissue  5  and the central bore opening  14  of the access cuff  10  exposes a working channel through the access cuff  10  to the cardiac tissue  5 . As illustrated in  FIG.  7   , the access cap  30  is engaged onto an outer wall surface of the medical device  150  and is preliminary positionally placed along the length of the medical device  150 . Alternatively, the access cap  30  may be coupled to the access cuff  10  prior to placement of the medical device  150 . A wire is placed into and through the central bore opening  14  of the access cuff  10 , such as by using the Seldinger technique. A dilator may be used over a wire to increase the cardiac tissue opening before passing the medical device  150  into and through the cardiac tissue  5  through the central bore opening  14  of the access cuff  10  and access cap  30 . Once the distal end medical device  150  is positioned with the heart, and in the case of a perfusion cannula the inflow openings  151  are positioned to open away from the cardiac valve  162 , the access cap  30  is sealed against the dual lumen perfusion cannula to achieve hemostasis as shown in  FIG.  8   . 
     As shown in  FIG.  9   , once the procedure is completed, such as by removing the patient from the ECMO machine, the access cap  30  is disengaged from the access cuff  10 , and the medical device  150  and access cap  30  are removed and the hemostatic plug or cap  54  is engaged with the access cuff  10  to occlude the central bore opening  14  of the access cuff  10  with hemostasis. 
     An alternative embodiment or variant of the access cuff system  45  as shown in  FIGS.  1 - 9    is shown in  FIGS.  10 - 21   . Turning now to  FIGS.  10 - 21   , the alternative access cuff system  100  is shown. Like access cuff system  45 , alternative access cuff system  100  includes an axial compression ring  106 , which may be unitary or segmented, a plurality of tissue anchor openings  105  arrayed about the entire circumference of the axial compression ring  106 , an attachment skirt  108 , and a central bore opening  107  passing through the axial compression ring  106 , the attachment skirt  108  and a plurality of tissue anchors  40 . Like with access cuff system  45 , the access axial compression ring  106 , attachment skirt  108 , and tissue anchors  40  are similar to the axial compression plate, sewing skirt, and tissue anchors disclosed U.S. Pat. No. 11,123,542, issued Sep. 21, 2021 (hereinafter the &#39;542 Patent) which is incorporated herein by reference in their entirety. 
     In addition, alternative access cuff system  100  includes a flanged tubular graft  102  having a central lumen  120  wherein the central lumen  120  is positioned in axial alignment with the central bore opening  107  and a radial flange  104  of the flanged tubular graft  102  is positioned between the axial compression ring  106  and the attachment skirt  108 . Flanged tubular graft  102  is comprised of a pliable graft material and cardiac or vascular access may be established through the central lumen  120 . In this configuration, as shown in  FIGS.  13  and  13   , the tissue anchors  40  pass into and through each of the tissue anchor openings  105 , into and through the radial flange  104  and the attachment skirt  108  and into the cardiac tissue  5  (not shown). In this configuration the tissue anchors  40  bear against an upper aspect  106   a  of the axial compression ring  106  causing an axial force to be applied to the attachment ring  108  and the radial flange  104  of the flanged tubular graft  102 . The radial flange  104  of the tubular graft  102  may be positioned between the axial compression ring  103  and the attachment skirt  108 , or as alternatively illustrated in  FIG.  13   , a lower surface  106   b  of the axial compression ring  106  may be adjacent the attachment skirt  108  and the radial flange  104  may be abutting a distal surface of the attachment skirt  108 , with the lumen  120  of the tubular graft  102  extending through the entire central bore opening  107  of the axial compression ring  106  and the attachment skirt  108 . Flanged tubular graft  102  may be similar to that disclosed in U.S. patent application Ser. No. 16/739,807, filed Jan. 10, 2020 (hereinafter the &#39;807 Patent Application), which is incorporated herein by reference in their entirety. 
     Optional second attachment skirt (not shown) may be interposed between a proximal surface of the radial flange  104  of flanged tubular graft  102  and a distal surface  106   b  the axial compression ring  106  and is concentric with a proximal tubular portion of tubular graft  102 . Alternatively or in addition, optional second attachment skirt may be interposed between a distal surface of the radial flange  104  and cardiac muscle tissue  5 . The compression assembly  130  may, optionally, be hemostatically integrated with the graft  102  such as, for example, by coating with silicone, reflowing, co-extruded during manufacture of the access cuff system  100 , adhesive joining of one or more of the compression ring  106 , attachment skirt  108 , and radial flange  104 . 
     The at least one attachment skirt  108  facilitates hemostasis with surgical attachment to the heart muscle  5  or vascular tissue and may be made of a flexible or rigid felt material, such as polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), or similar non-woven or woven material suitable for creating a hemostatic seal. 
     The tubular graft  102  and radial flange  104  may be a single unitary member or may be a hybrid assembly in which the tubular graft  102  and radial flange  104  are discrete members configured to be removably joined together. In the hybrid assembly, the tubular graft  102  is in whole in part of a rigid or semi-rigid tubular member having a connector, such as threads, snap-fit, interference fits, or the like, positioned at a distal end of the tubular graft. The connector at the distal end of the tubular graft removably engages with a mating connector associated with the radial flange  104 . 
     The central bore opening  107  of the axial compression ring  106  is configured to accommodate the graft  102  to pass through the central opening  107  and has a distal surface  106   b  configured to bear against the proximal surface of radial flange  14 . The plurality of tissue anchor openings  105  pass through the axial compression ring  106  and accommodate a plurality of tissue anchors  40  to pass through the openings  105  and into and through the both the attachment skirt  108  and the radial flange  104  and into the cardiac muscle tissue  5  to axially compress the annular compression assembly  130  against the cardiac muscle tissue  5  in a hemostatic manner. As is described in the &#39;542 Patent, incorporated by reference herein, the axial compression ring  106  may be a unitary ring member or a segmented ring member comprising two or more arcuate segments configured to form a continuous or discontinuous ring structure. Where the axial compression ring  106  is a segmented ring member, the two or more arcuate segments may, optionally, have projections and/or receivers that are configured to interdigitate with adjacent arcuate sections. In this configuration, the interdigitated arcuate members form a flexible annular ring structure that is capable of conforming to different surface topographies on the heart or vascular tissue. 
     The axial compression ring  106 , whether a continuous or discontinuous ring structure, may be made of a rigid biocompatible metal, such as titanium or stainless steel, or a flexible or semi-rigid material such as polyurethane, polyether ether ketone (PEEK) or similar polymeric material. The axial compression ring  106  may also be adhesively joined to the attachment skirt  108 . 
     Each of the plurality of tissue anchor openings  105  in the axial compression ring  106  may optionally have countersunk recesses and/or grommet members lining each of the plurality of openings. The grommet members may line the plurality of openings and, optionally, may have alignment projections that intercalate between the adjacent layers of the compression assembly  130  and assist in providing both alignment and substantially uniform compression and allow the compression assembly  130  to conform to a shape of the cardiac muscle tissue  5  or vascular tissue when joined thereto. 
     A delivery tool  7  is also provided as part of a system for coupling the axial compression ring  106  to cardiac  5  or vascular tissue. The delivery tool is similar to that described in U.S. Pat. No. 11,338,126 (hereinafter the &#39;126 Patent), which is hereby incorporated by reference in its entirety. In the &#39;126 Patent Application there is described a synchronous drive system to deliver an apical cuff and axial compression ring and synchronously drive tissue anchors into and through an apical cuff and into cardiac muscle tissue to secure an axial compression ring and apical cuff to cardiac muscle tissue. Like the delivery tool and synchronous drive system of the &#39;126 Patent, the delivery system of the present disclosure is capable of operating in a synchronous drive mode to simultaneously drive all of the plurality of tissue anchors  40 . However, unlike that delivery and synchronous drive system described in the &#39;126 Patent, the drive system must have a central bore through which the access graft of the present access device will pass and allow the delivery and synchronous drive system to engage the tissue anchors and drive them into the cardiac or venous tissue to axially compress the annular ring and graft thereto. Alternatively, the synchronous drive component may be eliminated and the delivery tool may simply have a delivery housing with a plurality of openings axially aligned with the tissue anchors  40  on the axial compression ring  106  to allow a drive tool to be inserted through each of the plurality of openings to drive each tissue anchor  40  and axially compress the annular ring  106  against the cardiac  5  or venous tissue. 
     Transabdominal access to heart  5  may be accomplished by a subxiphoid incision with or without partial inferior sternal split with use of a self-retaining retractor, e.g., a Bookwalter retractor. Once access to the heart  5  is established, the delivery tool  7  preloaded with the graft  102  and compression assembly  130 , is delivered through the incision, the radial flange  104  is positioned against the heart  5 , and the tissue anchors  40  axially driven to pass into and through the axial compression ring  106 , the attachment skirt  108 , and the radial flange  104  and into the heart muscle  5  thereby axially compressing the compression assembly  130  in a hemostatic manner to the heart muscle  5 . As noted above, the tissue anchors  40  may be axially driven synchronously or individually, into the heart muscle  5 , preferably without substantial axial force being applied to the tissue anchors  40  themselves but only a rotational force being employed to drive the tissue anchors  40  into the heart muscle  5 . 
     Once the access cuff system  100  is secured to the heart muscle  5  or vascular tissue, transcardiac or transvascular access accomplished through the central lumen  120  of the graft  102  and through either the cardiac muscle  5  or vascular tissue. 
     Where the two-piece assembly of the tubular graft  102  and removably coupled radial flange  104  is employed, the compression assembly  130  including the radial flange  104  is delivered with the delivery tool, the tissue anchors  40  are driven into the heart muscle  5  of vascular tissue heart muscle  5  in the manner as described above. After the delivery tool is removed, the tubular graft  102  is coupled to the radial flange  104  by engaging the connector on the distal end of the tubular graft  102  with the mating connector on the radial flange  14 . Access is then available through the central lumen  120  of the tubular graft  102  and the compression assembly  130 . 
     Once access is no longer required, closure and hemostasis may be achieved by clamping, suturing, and trimming the tubular graft  102  in the case of the unitary tubular graft. In the case of the two-piece assembly, the central opening  107  of the annular ring member  06  and radial flange  104  may be occluded with a cap (not shown) having a connector that mates with the radial flange connector. 
     In accordance with the present disclosure, there is also provided a medical device  150 , such as a perfusion cannula as described above, suitable for use in transabdominal or transthoracic cardiac or vascular access, ECMO, perfusion, exchange, and/or bypass. 
     At noted previously, at least one attachment skirt  108  is provided at either one surface of radial flange  104  or at both the proximal and distal surfaces of the radial flange  104 . 
     Tissue anchors  40  engage perpendicularly into and through the tissue anchor openings  105  in the axial compression ring  106 , the at least one attachment skirt  108 , and pass through the radial flange  104 , and into the cardiac muscle tissue  5  or vascular tissue. As discussed above, the tissue anchors  40  are deployed either individually, in groups, or simultaneously to couple the compression assembly  130  and the graft  102  to the cardiac muscle  5  or vascular tissue. The tissue anchors  40  exert an axially compressive force to secure the access cuff  10  to the cardiac muscle  5  or vascular tissue with hemostasis. As described in the &#39;126 Patent, the synchronous drive system described therein drives the tissue anchors  40  by application of a rotary force and without substantial axial force applied to the tissue anchors  40 . In this manner, rotation of the tissue anchors  40  drives the tissue anchors  40  into the attachment skirt  108  and the cardiac tissue  5 . 
     While the tissue anchors shown  40  in the accompanying Figures are shown as helical coil tissue screws, it will be understood that alternative tissue anchors, including, for example, sutures, barbs, pins, or the like, are also useful as tissue anchors in the present disclosure. 
     A retaining collar  140  is provided to hemostatically seal the tubular graft  102  circumferentially around the medical device  150  and bridges both the tubular graft  102  and the medical device  150  to circumferentially compress tubular graft  102  against an outer surface of the medical device  150  to create for hemostasis at the juncture there between. Retaining collar  140  has at least one arcuate segment that circumferentially surrounds the graft  102  and the catheter portion  102  of medical device  150 . A plurality of circumferential compression rings  142 , which may be ligatures, clamps, elastic bands, or the like, compress the at least one arcuate segment  140  against the graft  102  to hemostatically seal inner luminal walls of central lumen  120  of graft  102  against the medical device  150 . For example, where the medical device  150  is a perfusion cannula, as shown in  FIGS.  18  and  20   , the retaining collar  140  is placed over both the tubular graft  102  and the cannula  150  and retained by compression rings  142 . The plurality of compression rings  42  are removable to permit removing of the retaining collar  140  and disengagement of medical device  150  from the access cuff  10  when a procedure is completed. 
       FIG.  18    illustrates engagement of the access cuff system  100 , medical device  150 , in this case a perfusion cannula, and collar  140  with heart muscle tissue  5 . 
     Once a procedure is completed and the medical device  150  is disengaged from the access cuff system  100 , the central lumen  120  of graft  102  is hemostatically sealed such as by surgical staples or sutures  132  and the graft  102  is then trimmed to reduce the length of graft  102 , as shown in  FIG.  15   . 
     An alternative retaining collar  144  may be employed by employing a suture winding about the tubular graft  102  and the medical device  150  to create hemostasis at the juncture there between as depicted in  FIG.  16   . Then, after the procedure is completed and the medical device  150  removed from the tubular graft  102 , staples or sutures  132  may be used to close the central lumen  120  of the tubular graft  102  and the tubular graft  102  trimmed to a desired length. 
     Finally,  FIG.  21    depicts the compression assembly  130  with tubular graft  102  (not visible) joined to a medical device  150  by retaining collar  140 ; all joined to the heart muscle  5 . 
     While the present disclosure is made with reference to certain embodiments or variants, those skilled in the art will understand and appreciate that variations in materials, dimensions, tolerances, material properties, arrangements, procedural steps, and the like are all intended to be within the scope of the disclosure, which is intended to be limited only by the claims appended hereto.