Patent Publication Number: US-2021186547-A1

Title: Devices, systems, and methods for locally engaging tissue using suction

Description:
PRIORITY 
     The present PCT application is related to, and claims the priority benefit of, U.S. Provisional Patent Application Ser. No. 62/671,056, filed May 14, 2018, the contents of which are incorporated herein directly and by reference in their entirety. 
    
    
     BACKGROUND 
     Engagement catheters for use with suction to engage tissue within the mammalian body have become increasingly more important in the medical arts, as said catheters facilitate various medical procedures previously incapable of being performed without their use. 
     Embodiments of engagement catheters, providing improved functionality, stability, and the like, would be well received in the marketplace. 
     BRIEF SUMMARY 
     An exemplary catheter device for engaging tissue using suction of the present disclosure comprises an engagement catheter having a proximal end, a distal end, and a vacuum lumen therethrough operably coupling the proximal and distal ends; a cone shaped suction cup disposed at the distal end of the engagement catheter to engage a tissue of interest, the cone shaped suction cup comprising a first layer of a material and a second layer of a material bonded together, wherein the first layer of material forms an inside wall of the cone shaped suction cup and wherein the second layer of material forms an outside wall of the cone shaped suction cup; and a plurality of rigid structural vanes, disposed between the first and second layers of material to stiffen the cone shaped suction cup; and a distal end vacuum port disposed inside of the cone shaped suction cup and operably coupled to the vacuum lumen to suction a tissue of interest. 
     In at least one embodiment, the plurality of rigid structural vanes are each inflatable. In at least one embodiment, the plurality of inflatable rigid structural vanes are inflated to deploy the suction cup. In at least one embodiment, the plurality of inflatable rigid structural vanes are disposed longitudinally spaced apart along a length of the suction cup. In at least one embodiment, the plurality of inflatable rigid structural vanes are disposed longitudinally and radially along a length of the suction cup. In at least one embodiment, the plurality of inflatable rigid structural vanes are disposed in a spiral around the circumference of the suction cup. In at least one embodiment, the device further comprises an inflatable rigid structural vane circumferentially disposed around a distal most end of the suction cup. In at least one embodiment, the device further comprises at least two large welded structural vanes disposed longitudinally along a length of the suction cup. 
     In at least one embodiment, the plurality of inflatable rigid structural vanes are disposed in a symmetrical looping pattern. In at least one embodiment, the device further comprises an inflatable annular area or balloon disposed on a distal most end of the suction cup. In at least one embodiment, the inflatable annular area comprises a tangent donut to engage a tissue of interest. In at least one embodiment, the plurality of inflatable rigid structural vanes increases surface area contact with tissue to improve suction strength and sealing. In at least one embodiment, the cone shaped suction cup is shaped by way of an elongated tube of a shape memory material having a plurality of elongated strips removed from a length of the elongated tube to form elongated shape memory tines at the distal end of the tube, wherein the shape memory tines flare outward away from a central axis to form a fluted distal end; wherein the first layer of the material and the second layer of the material are effectively one unitary layer of an elastomeric coating; and wherein the plurality of rigid structural vanes are configured as the elongated shape memory tines. In at least one embodiment, the suction cup comprises a flared distal end. In at least one embodiment, the suction cup has a uniform wall thickness or a tapered wall thickness. In at least one embodiment, the suction cup has a tapered wall thickness. In at least one embodiment, the suction cup has a wall thickness greater near the proximal end and thinner near the distal end. In at least one embodiment, the first and second layers of material are formed of a shape memory material. In at least one embodiment, the first and second layers of material are formed of an elastomeric material and the rigid structural vanes are formed of a shape memory material. In at least one embodiment, the plurality of rigid structural vanes have a uniform width and are disposed longitudinally spaced apart along a length of the suction cup. In at least one embodiment, the plurality of rigid structural vanes are disposed longitudinally and radially along a length of the suction cup. In at least one embodiment, the plurality of rigid structural vanes are disposed in a spiral around the circumference of the suction cup. In at least one embodiment, the device further comprises an rigid structural vane circumferentially disposed around a distal most end of the suction cup. In at least one embodiment, the plurality of rigid structural vanes are disposed in a symmetrical looping pattern around a circumference of the suction cup. In at least one embodiment, the plurality of rigid structural vanes are disposed in a zig-zag pattern around a circumference of the suction cup. In at least one embodiment, the plurality of rigid structural vanes are disposed in an elongated zig-zag pattern along a length of the suction cup. 
     In at least one embodiment, the plurality of rigid structural vanes extend longitudinally along a length of the suction cup and are connected together radially by thinner zig-zag linkages. In at least one embodiment, the suction cup comprises a pleated self-expanding skirt-shaped cone. In at least one embodiment, the first and second layers of material are elastomeric molded into pleats. In at least one embodiment, the plurality of rigid structural vanes further comprise radiopaque markers thereon. In at least one embodiment, each of the plurality of rigid structural vanes further comprises a radiopaque marker at its distal end. In at least one embodiment, the device further comprises a handle operably coupled to the proximal end of the engagement catheter and having a vacuum port operably coupled to the vacuum lumen for providing suction therethrough via an external vacuum source. 
     In at least one embodiment of a catheter system for engaging tissue using suction, the catheter system comprises an engagement catheter having a proximal end, a distal end, and a vacuum lumen therethrough operably coupling the proximal and distal ends; a handle operably coupled to the proximal end of the engagement catheter and having a vacuum port operably coupled to the vacuum lumen for providing suction therethrough via an external vacuum source; a cone shaped suction cup disposed at the distal end of the engagement catheter to engage a tissue of interest, the cone shaped suction cup comprising a first layer of a material and a second layer of material bonded together, wherein the first layer of material forms an inside wall of the cone shaped suction cup and wherein the second layer of material forms an outside wall of the cone shaped suction cup; and a plurality of rigid structural vanes, disposed between the first and second layers of material to stiffen the cone shaped suction cup; and a distal end vacuum port disposed inside of the cone shaped suction cup and operably coupled to the vacuum lumen to suction a tissue of interest; and a sleeve slidingly disposed around the engagement catheter and operably coupled to the handle, wherein movement of the sleeve relative to the engagement catheter will collapse or expand the suction cup. 
     In at least one embodiment, the suction cup is operable via the handle to retract into the sleeve. In at least one embodiment, the suction cup further comprises longitudinal pleats and to facilitate folding and retraction into the sleeve. In at least one embodiment, the suction cup further comprising a longitudinally pleated sleeve attached to an outer sheath at the proximal end and attached to an inner sheath at the distal end, wherein extension of the outer sheath, relative to a stationary inner sheath, will invert the longitudinally pleated sleeve to form the suction cup. In at least one embodiment, the sleeve further comprises a plurality of longitudinally disposed shape memory material linkages coupled to an outer sheath at the proximal end and coupled to an inner sheath at a distal end, wherein extension of the outer sheath, relative to a stationary inner sheath, will invert the longitudinally disposed shape memory material linkages to form the suction cup. In at least one embodiment, the engagement catheter further comprises a needle having a lumen sized and shaped to receive a guidewire therethrough. 
     In at least one embodiment, the system further comprises a needle for perforation of a fossa ovalis. In at least one embodiment, the handle further comprises detents and a locking pin operably configured to aid in retraction of the engagement catheter. In at least one embodiment, the handle further comprises a detent collet operably configured to extend the engagement catheter. In at least one embodiment, the vacuum port on the handle further comprises three-way stop cock to aid in turning suction on and off. In at least one embodiment, the handle further comprises a canted coil spring detent for expanding and collapsing the suction cup. In at least one embodiment, the handle further comprises dual hemostasis seals sized to provide a tight sealing connection while receiving guidewires, dilators or catheters. In at least one embodiment, the handle further comprises a thumb wheel for precise control over expansion and collapse of the suction cup. In at least one embodiment, the suction cup is operable to engage tissue when only partially expanded. In at least one embodiment, the handle is detachably coupled to the sleeve via a removable handle locking pin. 
     In at least one embodiment of a method of forming a catheter device for engaging tissue using suction, the method comprises selecting an elongated tubular section of shape memory material; laser cutting the elongated tubular section of shape memory material, to form: i) a plurality of elongated structural vanes separated by longitudinal slits laser cut into a distal most end of the tubular section; and ii) a plurality of tear-dropped shaped cut-outs within a distal most end of each elongated structural vane; heat setting the elongated tubular section of shape memory material to flare the plurality of elongated structural vanes away from a central longitudinal axis to form a fluted distal end; and sealing the fluted distal end with an elastomeric coating to form a cone shaped suction cup for engaging and suctioning tissue. 
     In at least one embodiment, heat setting the elongated tubular section comprises heat setting at 500° C.-550° C. In at least one embodiment, the plurality of elongated structural vanes form a framework upon which an elastomeric coating may be formed, the elastomer coating selected from the group consisting of: silicon or polyurethane. In at least one embodiment, the elongated tubular section of shape memory material further comprises elongated oval-shaped attachment slots around a circumference of the tubular section, at a most proximal end, for coupling to the catheter. In at least one embodiment, sealing the fluted distal end with an elastomeric coating, further comprising applying the elastomeric coating with a tapered wall thickness. In at least one embodiment, the fluted distal end further comprises two curved sections and a straight section. 
     In at least one embodiment, of a catheter device for engaging tissue using suction, the catheter device comprises an engagement catheter having a proximal end, a distal end, and a vacuum lumen therethrough operably coupling the proximal and distal ends; an elongated tube of a shape memory material having a plurality of elongated strips removed from a length of the elongated tube to form elongated shape memory tines at a distal end of the tube, wherein the shape memory tines flare outward away from a central axis to form a fluted distal end; and an elastomeric coating disposed over the elongated shape memory material tines to form a suction cup shape. In at least one embodiment, the shape memory material is Nitinol. In at least one embodiment, the elastomeric coating is polyurethane or silicone. In at least one embodiment, the device further comprises teardrop shaped elongated slots disposed in a distal most end of each of the shape memory material tines. In at least one embodiment, the device further comprises elongated oval shaped attachment slots disposed in the proximal end of the suction cup for attachment to the engagement catheter. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The disclosed embodiments and other features, advantages, and disclosures contained herein, and the matter of attaining them, will become apparent and the present disclosure will be better understood by reference to the following description of various exemplary embodiments of the present disclosure taken in conjunction with the accompanying drawings, wherein: 
         FIG. 1  shows a perspective view of an engagement catheter having a cone-shaped suction cup at its distal end, whereby the cone-shaped suction cup has one or more inflatable structural longitudinal vanes, according to an exemplary embodiment of the present disclosure; 
         FIG. 2  shows an exemplary structural geometric rendering of the cone-shaped suction cup of the engagement catheter of  FIG. 1  having one or more inflatable structural longitudinal vanes, according to an exemplary embodiment of the present disclosure; 
         FIG. 3  shows a perspective view of an exemplary engagement catheter having a cone-shaped suction cup at its distal end with one or more inflatable structural longitudinal and radial vanes, according to an exemplary embodiment of the present disclosure; 
         FIG. 4  shows a cone-shaped suction cup  1830  having a greater number i.e., density, of longitudinally disposed structural vanes  6010 ; 
         FIG. 5  illustrates the cone-shaped suction cup  1830  having a spiral structural vane or vanes  6010  disposed radially around its circumference; 
         FIG. 6  illustrates a cone-shaped suction cup  1830  having longitudinally disposed structural vanes  6010  which are partially radially attached to one another; 
         FIG. 7  illustrates a cone-shaped suction cup  1830  having large longitudinally disposed structural vanes  6010  welded therein; 
         FIG. 8  illustrates a flute-shaped suction cup  1830  having a larger inflatable annular area, or balloon  6700 , disposed on the distal end  6100  of the flute-shaped suction cup  1830 ; 
         FIG. 9  illustrates a cross sectional view of the embodiment of  FIG. 8  having a larger inflatable annular area or balloon  6700  disposed on the distal end  6100  of the flute-shaped suction cup  1830 ; 
         FIG. 10  illustrates an engagement catheter  1810  having an even larger inflatable area or tangent donut  6900  positioned at distal end  720 ; 
         FIG. 11  illustrates a cross-sectional view of the inflated tangent donut  6900  of the embodiment of  FIG. 10 ; 
         FIG. 12  shows a cross-sectional view of the deflated tangent donut  6900  of the embodiment shown in  FIG. 10 ; 
         FIG. 13  illustrates a cross-sectional view of a different embodiment of an inflated tangent donut  6900  disposed on a distal end  720  of the engagement catheter  1810 ; 
         FIG. 14  illustrates a cross-sectional view of an embodiment of a deflated tangent donut  6900  of the embodiment shown in  FIG. 13 ; 
         FIG. 15  illustrates an embodiment of an engagement catheter  1810  having a dip-molded cone-shaped suction cup  1830  disposed on its distal end  720 ; 
         FIG. 16  illustrates a cross-sectional view of the dip-molded cone-shaped suction cup  1830  having a tapered wall thickness; 
         FIG. 17  illustrates an embodiment of an engagement  1810  catheter having a collapsed cone-shaped suction cup  1830 ; 
         FIG. 18  illustrates an embodiment of the engagement catheter  1810  of  FIG. 17  having a cone-shaped suction cup  1830  in an expanded or deployed configuration; 
         FIGS. 19 &amp; 20  illustrate an exemplary embodiment of an engagement catheter  1810  having a Nitinol suction cup  1830  disposed on its distal end  720  in an expanded configuration; 
         FIGS. 21, 22 , &amp;  23  illustrate an exemplary embodiment of an engagement catheter  1810  having a Nitinol cone-shaped suction cup  1830  disposed on its distal end  720 ; 
         FIGS. 24 &amp; 25  illustrate an exemplary embodiment of an engagement catheter  1810  having a Nitinol cone-shaped suction cup  1830  disposed on its distal end  720 ; 
         FIG. 26  illustrates an exemplary embodiment of an engagement catheter  1810  having a braided Nitinol flute  1830  on its distal end  720 ; 
         FIGS. 27, 28 , &amp;  29  illustrate an exemplary embodiment of an engagement catheter  1810  where the suction cup  1830  comprises a self-expanding pleated skirt shaped cone  1830 ; 
         FIG. 30  illustrates an exemplary embodiment of an engagement catheter  1810  having a pleated skirt shaped suction cup  1830  which can invert to then form the skirt shaped suction cup  1830 ; 
         FIG. 31  illustrates several exemplary embodiments of an engagement catheter  1810  having a pleated skirt shaped suction cup  1830  which can invert to then form the skirt shaped suction cup  1830 , as shown in  FIG. 30 ; 
         FIGS. 32 &amp; 33  illustrate an exemplary embodiment of an engagement catheter  1810  having a cone-shaped suction cup  1830  which can also be retracted to then invert and form the cone-shaped suction cup  1830 ; 
         FIGS. 34 &amp; 35  illustrate an exemplary embodiment of an engagement catheter  1810  having a cone-shaped suction cup  1830  which can also be retracted to then invert and form the cone-shaped suction cup  1830 ; 
         FIG. 36  illustrates exemplary cone package calculations and exemplary cone material thickness calculations for the cone-shaped suction cup  1830  of the present invention; 
         FIG. 37  illustrates an end view of the distal end  6100  of the cone-shaped suction cup  1830  of the present invention; 
         FIG. 38  illustrates a cross-sectional view of the engagement catheter  1810 ; 
         FIGS. 39-41  illustrate various exemplary graft embodiments of cone-shaped suction cup  1830  of the engagement catheter  1810 ; 
         FIGS. 42 &amp; 43  illustrate perspective views of an engagement catheter  1810  for engaging a tissue  1770  of interest; 
         FIG. 44  illustrates a side view of a distal end  720  of an engagement catheter  1810  having a flute-shaped suction cup  1830  in a collapsed or retracted configuration; 
         FIG. 45  illustrates a side view of a distal end  720  of an engagement catheter  1810  having a flute-shaped suction cup  1830  in a deployed or expanded configuration; 
         FIG. 46  illustrates a cross-sectional view of a distal end  720  of an engagement catheter  1810  adjacent to tissue  1770  of interest; 
         FIG. 47  illustrates a cross-sectional view of a distal end  720  of an engagement catheter  1810  engaging and applying suction to tissue  1770  of interest; 
         FIG. 48  illustrates a cross-sectional view of a distal end  720  of an engagement catheter  1810  with internal needle puncturing tissue  1770  of interest; 
         FIG. 49  illustrates a cross-sectional view of a cross-sectional view of a distal end  720  of an engagement catheter  1810  with internal dilator expanding tissue  1770  of interest; 
         FIG. 50  illustrates a perspective view of a flute-shaped suction cup  1830  of the present invention with multiple flexible Nitinol tines; 
         FIGS. 51 &amp; 52  illustrate perspective views of the handle  1900  of an engagement catheter  1810  of the present invention with forward and backward detents  1904  for collapsing or expanding the suction cup  1830 ; 
         FIG. 53  illustrates a perspective view of the handle  1900  on the proximal end  710  of an engagement catheter  1810  of the present invention with locking pin  1906 ; 
         FIG. 54  illustrates a perspective view of the handle  1900  on the proximal end  710  of an engagement catheter  1810  of the present invention with canted coil spring detent  1912 ; 
         FIG. 55  illustrates a perspective view of the handle  1900  on the proximal end  710  of an engagement catheter  1810  of the present invention having a dual hemostasis seal  1914  thereon; 
         FIG. 56  illustrates a perspective view of a flute or cone-shaped suction cup  1830  of the present invention with longitudinally disposed structural vanes  6010  in a zig-zag configuration 
         FIG. 57  illustrates a perspective view of a removable handle  1900  on the proximal end  710  of an engagement catheter  1810  having a thumb wheel  1916  for deploying and collapsing the suction cup  1830 ; 
         FIG. 58  illustrates a perspective view of a removable handle  1900  on the proximal end  710  of an engagement catheter  1810  which can be removed via handle locking pin  1918 ; 
         FIG. 59  illustrates a perspective view of the proximal end  710  of an outer sheath  1800  having a hemostasis valve (or dual valves) on the proximal end  720  thereof; 
         FIG. 60  illustrates a perspective view of a flute or cone-shaped suction cup  1830  of the present invention with longitudinally disposed structural wire Nitinol vanes  6010  arranged around the circumference of the suction cup  1830  in a looped design similar to that of flower petals; 
         FIG. 61  illustrates three steps of the process used to form a Nitinol structural vane frame; 
         FIG. 62  illustrates a perspective view of a Nitinol structural vane frame; 
         FIG. 63  illustrates a side view of a Nitinol frame formed of curved structural vanes; 
         FIG. 64  illustrates a side view of a Nitinol frame formed of curved and straight structural vanes; 
         FIG. 65  illustrates a perspective view of an elastomeric cone-shaped suction cup formed over a Nitinol structural vane frame; and 
         FIG. 66  illustrates two steps of the process used to form a spring or spiral-shaped Nitinol structural vane frame. 
     
    
    
     Each of the aforementioned figures pertain to at least one exemplary embodiment of the present disclosure for the subject matter referenced therein. 
     As such, an overview of the features, functions and/or configurations of the components depicted in the various figures will now be presented. It should be appreciated that not all of the features of the components of the figures are necessarily described and some of these non-discussed features (as well as discussed features) are inherent from the figures themselves. Other non-discussed features may be inherent in component geometry and/or configuration. Furthermore, wherever feasible and convenient, like reference numerals are used in the figures and the description to refer to the same or like parts or steps. The figures are in a simplified form and not to precise scale. 
     DETAILED DESCRIPTION 
     For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of this disclosure is thereby intended. 
     The present disclosure includes various devices, systems, and methods for engaging tissue using suction. As shown in  FIG. 1 , for example, an exemplary engagement catheter  1810  of the present disclosure comprises a cone-shaped suction cup  1830  at a distal end  720  of engagement catheter  1810  having a configuration allowing cone-shaped suction cup  1830  itself to be inflated and/or deflated as desired. As shown in  FIG. 1 , cone-shaped suction cup  1830  comprises a first layer of material  6000  and a second layer of material  6002  positioned adjacent to one another, whereby first layer of material  6000  is on a relative outside of cone-shaped suction cup  1830  and whereby second layer of material  6002  is on a relative inside of cone-shaped suction cup  1830 . Said layers of material  6000 ,  6002  may be referred to as film layers, and in various embodiments, such as shown in  FIG. 1 , layers of material  6000 ,  6002  are welded or otherwise bonded to one another so to create a plurality of structural vanes  6010 , which themselves can be inflated to deploy cone-shaped suction cup  1830  and/or generally provide a structural rigidity, or stiffen, cone-shaped suction cup  1830  so that cone-shaped suction cup  1830  can ultimately engage a tissue  1770  of interest under suction/vacuum. Cone-shaped suction cup  1830  can then be deflated prior to retraction into engagement catheter  1810 . In the present embodiment, and potential other embodiments, of the present disclosure, the various structural vanes  6010 , and potentially other areas in between first layer of material  6000 , and second layer of material  6002 , can be inflated and/or deflated as desired. In an exemplary embodiment, best shown in  FIG. 2 , cone-shaped suction cup  1830  comprises a proximal end  6012  having a circumference substantially similar to an outer circumference of engagement catheter  1810 , and a distal end  6100  having a circumference larger than the outer circumference of the engagement catheter  1810 . 
       FIG. 2  shows an exemplary structural geometric rendering of the approximately cone-shaped suction cup  1830  of engagement catheter  1810  of  FIG. 1 . As shown in  FIG. 2 , there may be a number of inflatable or structural vanes  6010  in spaced apart relation running longitudinally along the length of cone-shaped suction cup  1830 . As shown in  FIGS. 1 and 2 , the structural vanes  6010  may be disposed along only a portion of the length of cone-shaped suction cup  1830 . The structural vanes begin on the distal end  720  of the engagement catheter  1810  or on the proximal end  6102  of the cone-shaped suction cup  1830  and then terminate before reaching the distal end  6100  of cone-shaped suction cup  1830 . The proximal end  6102  of the cone-shaped suction cup  1830  is the narrower end adjacent to the distal end  720  of engagement catheter  1810 . The distal end  6100  of the cone-shaped suction cup  1830  comprises the larger flared end or rim of the cone-shaped suction cup  1830 . 
     The embodiments shown in  FIGS. 3-14  illustrate some of the different exemplary designs for structural vanes  6010 , which themselves can be inflated to deploy cone-shaped suction cup  1830  and generally stiffen cone-shaped suction cup  1830  so that cone-shaped suction cup  1830  can ultimately engage a tissue  1770  of interest under suction/vacuum. 
       FIG. 3  illustrates a cone-shaped suction cup  1830  having a plurality of both radially and longitudinally disposed structural vanes  6010 . Structural vanes  6010  may extend along the entire length of cone-shaped suction cup  1830 , as well as along a portion of distal end  720  of engagement catheter  1810 . There may be any number of structural vanes  6010 , having the same or different sizes, shapes, or thicknesses as shown in  FIG. 3 . As shown in  FIG. 3 , a structural vane or a plurality of structural vanes  6010  may also be radially disposed around the circumference of the cone-shaped suction cup  1830 . Additionally, a structural vane  6010  may also be radially disposed around the perimeter of the distal end  6100  of the cone-shaped suction cup  1830 , as shown in  FIG. 3 . Having the inflatable structural vanes  6010  on the distal end  6100  of cone-shaped suction cup  1830  increases surface area contact with tissue  1770  to improves suction strength and sealing capabilities. 
       FIG. 4  illustrates a cone-shaped suction cup  1830  having a greater number i.e., density, of longitudinally disposed structural vanes  6010 . Structural vanes  6010  extend along the entire length of cone-shaped suction cup  1830  and along a portion of the distal end  720  of engagement catheter  1810 . The structural vanes  6010  may terminate at the distal end  6100  of the cone-shaped suction cup  1830 . As shown in  FIG. 4 , the distance between structural vanes  6010  may be decreased to increase the total number of longitudinal structural vanes  6010  on cone-shaped suction cup  1830 . The greater number, or higher density, of structural vanes  6010  adds rigidity or stiffness to cone-shaped suction cup  1830  to improve strength of inflation and suction and/or vacuum of a tissue  1770  of interest. 
       FIG. 5  illustrates the cone-shaped suction cup  1830  having a spiral structural vane or vanes  6010  disposed radially around its circumference. The spiral structural vane  6010  may also be radially disposed around the perimeter of the distal end  6100  of the skirt or suction cup  1830 . Having the inflatable structural vanes  6010  on the distal end  6100  of cone-shaped suction cup  1830  increases surface area contact with tissue  1770  to improve suction strength and sealing capabilities. 
       FIG. 6  illustrates a cone-shaped suction cup  1830  having longitudinally disposed structural vanes  6010  which are partially radially attached to one another. Structural vanes  6010  extend along the length of cone-shaped suction cup  1830  and along a portion of the distal end  6100  of engagement catheter  1810 . At some areas along the cone-shaped suction cup  1830 , the vanes may be disposed radially for a portion of the circumference of the skirt of suction cup  1830  to connect or partially connect the longitudinally disposed structural vanes  6010 . Portions of the radially disposed structural vanes  6010  may also be disposed around the perimeter of the distal end  6100  of the cone-shaped suction cup  1830 . 
       FIG. 7  illustrates a cone-shaped suction cup  1830  having large longitudinally disposed structural vanes  6010  welded therein. The larger structural vanes  6010  may further include welds therein tacking layers  6000 ,  6002  together. The larger size of the structural vanes  6010  may also reduce the overall number of structural vanes  6010  needed to inflate the cone-shaped suction cup  1830 . For example, only 2 larger sized structural vanes  6010  may be used. This embodiment may also include a structural vane  6010  located around the perimeter of the distal end  6100  of the cone-shaped suction cup  1830 . 
       FIG. 8  illustrates a flute-shaped suction cup  1830  having a larger inflatable annular area, or balloon  6700 , disposed on the distal end  6100  of the flute-shaped suction cup  1830 . The larger inflatable balloon area  6700 , may be one of the structural vanes  6010  or may be a separate inflatable balloon  6700 . The balloon  6700  can be inflated to function similarly to the flute-shaped suction cup  1830  to ultimately engage a tissue  1770  of interest under suction/vacuum. The balloon  6700  can then be deflated prior to retraction into engagement catheter  1810 . In addition to the balloon  6700 , there may also be a number of structural vanes  6010  disposed longitudinally along the flute-shaped suction cup  1830  and/or along distal end  720  of engagement catheter  1810 . The balloon  6700  and the structural vanes  6010  may be separate structures and thus, independently operable. The larger inflatable balloon  6700  increases surface area contact with tissue  1770  to improve suction strength and sealing capabilities with tissue  1770 . 
       FIG. 9  illustrates a cross sectional view of the embodiment of  FIG. 8  having a larger inflatable annular area or balloon  6700  disposed on the distal end  6100  of the flute-shaped suction cup  1830 . 
       FIG. 10  illustrates an engagement catheter  1810  having an even larger inflatable area or tangent donut  6900  positioned at distal end  720 . The tangent donut  6900  may be a large inflatable annular ring. The tangent donut  6900  can be inflated to function similarly to the cone-shaped suction cup  1830  to ultimately engage a tissue  1770  of interest under suction/vacuum. Tangent donut  6900  can then be deflated prior to retraction into engagement catheter  1810 . The tangent donut  6900  may be disposed directly on the distal end  720  of engagement catheter. 
       FIG. 11  illustrates a cross-sectional view of the inflated tangent donut  6900  of the embodiment of  FIG. 10 .  FIG. 12  shows a cross-sectional view of the deflated tangent donut  6900  of the embodiment shown in  FIG. 10 . When tangent donut  6900  is deflated, it may be retracted into the engagement catheter  1810 .  FIG. 13  illustrates a cross-sectional view of a different embodiment of an inflated tangent donut  6900  disposed on a distal end  720  of the engagement catheter  1810 .  FIG. 14  illustrates a cross-sectional view of an embodiment of a deflated tangent donut  6900  of the embodiment shown in  FIG. 13 .  FIG. 15  illustrates an embodiment of an engagement catheter  1810  having a dip-molded cone-shaped suction cup  1830  disposed on its distal end  720 . The dip-molded cone-shaped suction cup  1830  may be a shape memory material designed to automatically deploy or expand into a cone-shaped suction cup  1830  to ultimately engage a tissue  1770  of interest. When cone-shaped suction cup  1830  is retracted up into sleeve  1800  (not shown in  FIG. 15 ), the cone-shaped suction cup  1830  can be deformed for retraction to fit within engagement catheter  1810 . The wall thickness of the dip-molded cone-shaped suction cup  1830  is designed to be uniform or tapered to ensure the cone-shaped suction cup  1830  collapses and fits into the sleeve  1800  of engagement catheter  1810  for retraction. If the wall thickness is tapered, the wall thickness would be greater near the proximal end  6102  of the cone-shaped suction cup  1830  and then become thinner (or taper) toward the distal end  6100  of the cone-shaped suction cup  1830 . 
       FIG. 16  illustrates a cross-sectional view of the dip-molded cone-shaped suction cup  1830  having a tapered wall thickness. Wall thickness would be greater near the proximal end  6102  of the cone-shaped suction cup  1830  and then become thinner (or taper) toward the distal end  6100  of the cone-shaped suction cup  1830 .  FIGS. 17 &amp; 18  illustrate an embodiment of an engagement catheter having a Nitinol cone-shaped suction cup  1830  disposed on its distal end  720 . The Nitinol cone-shaped suction cup  1830  comprises a first layer of material  6000  and a second layer of material  6002  positioned adjacent to one another, whereby first layer of material  6000  is on a relative outside of cone-shaped suction cup  1830  and whereby second layer of material  6002  is on a relative inside of cone-shaped suction cup  1830 . Said layers of material  6000 ,  6002  may be referred to as film layers, and in various embodiments, are layered via a coating process or welded or otherwise bonded to one another so to create a web around the plurality of structural vanes  6010 , which themselves can be expanded to deploy cone-shaped suction cup  1830  and generally provide a structural rigidity, or stiffen, cone-shaped suction cup  1830  so that cone-shaped suction cup  1830  can ultimately engage a tissue  1770  of interest under suction/vacuum. 
     The structural vanes of this embodiment are formed by cutting a Nitinol tube and heat setting the vanes into a cone shape that will automatically expand cone-shaped suction cup  1830  when deployed from sleeve  1800 . The Nitinol cone-shaped suction cup  1830  embodiments are either dip-coated or fused with at least 2 layers  6000 ,  6002  of an elastomeric film such as polyurethane to fill the interstitial spaces allowing the design embodiments to seal. The Nitinol parts will be electropolished to remove any sharp edges prior to coating or covering. The Nitinol cone-shaped suction cup  1830  is a shape memory material designed to automatically deploy or expand into a cone-shaped suction cup  1830  to ultimately engage a tissue  1770  of interest. When cone-shaped suction cup  1830  is retracted up into sleeve  1800  (not shown in  FIGS. 17 &amp; 18 ), the cone-shaped suction cup  1830  can be deformed for retraction to fit within sleeve  1800 . 
       FIG. 17  illustrates an embodiment of an engagement  1810  catheter having a collapsed cone-shaped suction cup  1830 . The cone-shaped suction cup  1830  has longitudinally disposed structural vanes  6010  extending from the distal end  720  of the engagement catheter  1810 . As shown in  FIG. 17 , the cone-shaped suction cup  1830  may have 4 or more structural vanes  6010  which extend the entire length of the cone-shaped suction cup  1830 .  FIG. 18  illustrates an embodiment of the engagement catheter  1810  of  FIG. 17  having a cone-shaped suction cup  1830  in an expanded or deployed configuration, so that cone-shaped suction cup  1830  can engage a tissue  1770  of interest.  FIGS. 19 &amp; 20  illustrate an exemplary embodiment of an engagement catheter  1810  having a Nitinol suction cup  1830  disposed on its distal end  720  in an expanded configuration. In this embodiment, the suction cup  1830  has longitudinally disposed curving structural vanes  6010  extending along the length of the engagement catheter  1810 . The structural vanes  6010  have a uniform thickness and are evenly disposed in a repeating pattern around the circumference of the suction cup  1830 .  FIGS. 21, 22 , &amp;  23  illustrate an exemplary embodiment of an engagement catheter  1810  having a Nitinol cone-shaped suction cup  1830  disposed on its distal end  720 . In this embodiment, the cone-shaped suction cup  1830  has a plurality of longitudinally disposed structural vanes  6010  which are connected together by thinner angled linkages  6010 . The structural vanes  6010  may have varying thicknesses.  FIGS. 21 &amp; 22  shows the cone-shaped suction cup  1830  in a collapsed configuration.  FIG. 23  shows the cone-shaped suction cup  1830  in an expanded or deployed configuration.  FIGS. 24 &amp; 25  illustrate an exemplary embodiment of an engagement catheter  1810  having a Nitinol cone-shaped suction cup  1830  disposed on its distal end  720 . In this embodiment, the cone-shaped suction cup  1830  has a plurality of longitudinally disposed thick structural vanes  6010  which are connected together radially by thinner zig-zagging spring-like linkages  6010 . The spring-like linkages  6010  may have varying thicknesses.  FIG. 24  shows the cone-shaped suction cup  1830  in a collapsed configuration.  FIG. 25  shows the cone-shaped suction cup  1830  in an expanded or deployed configuration. 
       FIG. 26  shows a flute-shaped Nitinol braid  1830  that could be attached to the distal end  720  of an engagement catheter  1810 . The Nitinol braid  1830  can be heat set and dip molded or laminated to create a flexible cone or flute-shaped suction cup  1830 .  FIGS. 27, 28 , &amp;  29  illustrate an exemplary embodiment of an engagement catheter  1810  where the suction cup  1830  comprises a self-expanding pleated skirt-shaped cone  1830 . The pleated cone may be made of an elastomeric material and the pleats could be molded. The longitudinally disposed pleats facilitate folding or collapse of the skirt-shaped suction cup  1830  for retraction into sleeve  1800 . The pleated skirt-shaped suction cup  1830  is designed to automatically deploy or expand into a skirt-shaped suction cup  1830  to ultimately engage a tissue  1770  of interest. When pleated skirt-shaped suction cup  1830  is retracted into sleeve  1800 , the skirt or suction cup  1830  can be deformed for retraction to fit within engagement catheter  1810 .  FIG. 28  shows a cross-sectional view of the distal end  6100  of the skirt or suction cup  1830  having a pleated skirt  1830  in both collapsed (shown in the left  FIG. 28 ) and expanded (shown in the right  FIG. 28 ) configurations. 
       FIGS. 30 &amp; 31  illustrate an exemplary embodiment of an engagement catheter  1810  having a longitudinally pleated sleeve that is attached to an outer sheath at the proximal end  6100  and attached to an inner sheath at the distal end  720 . In operation, the outer sheath would be extended while the inner sheath would remain stationary causing the longitudinally pleated sleeve to then invert and form the cone-shaped skirt or suction cup  1830 . The inversion could also be achieved when the outer sheath is stationary and the inner sheath is retracted. This embodiment of skirt or the suction cup  1830  has a plurality of longitudinally disposed pleats and a crease  9000  for inversion.  FIGS. 32 &amp; 33  illustrate an exemplary embodiment of an engagement catheter  1810  having a sleeve with a plurality of longitudinally disposed Nitinol linkages, attached to an outer sheath at the proximal end and attached to an inner sheath at the distal end. In operation, the outer sheath would be extended while the inner sheath would remain stationary causing the longitudinally disposed Nitinol linkages to then invert and form the cone-shaped skirt or suction cup  1830 . The inversion could also be achieved when the outer sheath is stationary and the inner sheath is retracted. This embodiment of the cone-shaped skirt or suction cup  1830  is flexible and non-pleated and has a plurality of longitudinally disposed Nitinol structural linkages  6010  and a crease  9000  for inversion. 
       FIGS. 34 &amp; 35  illustrate an exemplary embodiment of an engagement catheter  1810  having a cylindrical sleeve that is attached to an outer sheath at the proximal end and attached to an inner sheath at the distal end. In operation, the outer sheath would be extended while the inner sheath would remain stationary causing the cylindrical sleeve to then invert and form the cone-shaped skirt or suction cup  1830 . The inversion could also be achieved when the outer sheath is stationary and the inner sheath is retracted. This embodiment of the cone-shaped suction cup  1830  is flexible and non-pleated and has no structural vanes  6010 , but does have a crease  9000  for inversion.  FIG. 36  illustrates exemplary cone package calculations and exemplary cone material thickness calculations for the cone-shaped suction cup  1830  of the present invention.  FIG. 37  illustrates an end view of the distal end  6100  of the cone-shaped suction cup  1830  of the present invention. This embodiment illustrates the structural vanes  6010  and lumen of the engagement catheter  1810 . The cone-shaped suction cup  1830  material thickness must fit into the annular space between both the sleeve  1800  and the engagement catheter  1810 . 
       FIG. 38  illustrates a cross-sectional view of the engagement catheter  1810 . As shown in  FIG. 38 , a sleeve  1800  is present around at least a portion of the engagement catheter  1810 . Sleeve  1800  may comprise a rigid or flexible tube having a lumen  730  therethrough, appearing around the outside of the engagement catheter  1810  and slideably engaging engagement catheter  1810  such that movement of the sleeve  1800  relative to engagement catheter  1810  can cause cone-shaped suction cup  1830  to be collapsed within or expanded external to sleeve  1800 . Engagement catheter  1810  has a lumen  740  therethrough for slideably engaging a dilation catheter  1840  (shown in  FIGS. 48 &amp; 49 ), which may be used to guide a needle  1890  to puncture the tissue  1770  of interest and then dilate the tissue  1770  of interest. After the tissue  1770  of interest has been dilated, the suction cup  1830  is collapsed and the engagement catheter  1810  and sleeve  1800  can be passed through the tissue  1770  of interest to facilitate the delivery of additional catheters or other products (gas, liquid, and or medications, etc). A dilation catheter  1840  is present at least partially within the lumen  740  of engagement catheter  1810 , and engagement catheter is placed at least partially within the lumen  730  of sleeve  1800 . The dilation catheter  1840  is configured to fit within engagement catheter  1810  and configured for sliding movement relative to engagement catheter  1810 . Also shown in  FIG. 38 , the engagement catheter  1810  may further comprise a needle  1890  having a sharp tip capable of puncturing a tissue  1770 . In various embodiments, as shown in  FIG. 38 , needle lumen is sized and shaped to receive a guide wire  1050  therethrough. The guide wire  1050  can be advanced through a needle  1890  into the atrial or pericardial space to secure the point of entry and guide further insertion of dilation catheter  1840  or another catheter. 
       FIGS. 39-41  illustrate various exemplary graft embodiments of cone-shaped suction cup  1830  of the engagement catheter  1810 .  FIGS. 42 &amp; 43  illustrate perspective views of an engagement catheter  1810  for engaging a tissue  1770  of interest. As shown in  FIGS. 42 &amp; 43 , an exemplary engagement catheter has a sleeve  1800  slideably engaging engagement catheter  1810 , which allows suction cup  1830  to expand when needed. The engagement catheter  1810  may further comprise a vacuum port  770  for connection to an external vacuum source to allow suction cup  1830  to engage a tissue  1770  of interest using suction. The engagement catheter  1810  has a handle  1900  at its proximal end  710  and the flute-shaped suction cup  1830  at its distal end  720 .  FIG. 42  illustrates the flute-shaped suction cup  1830  collapsed or retracted back into engagement catheter  1810 .  FIG. 43  illustrates the flute-shaped suction cup  1830  in an expanded or deployed configuration.  FIG. 44  illustrates a side view of a distal end  720  of an engagement catheter  1810  having a flute-shaped suction cup  1830  in a collapsed or retracted configuration.  FIG. 45  illustrates a side view of a distal end  720  of an engagement catheter  1810  having a flute-shaped suction cup  1830  in a deployed or inflated configuration.  FIG. 46  illustrates a cross-sectional view of a distal end  720  of an engagement catheter  1810 . In this embodiment, the engagement catheter  1810  is retracted and the flute-shaped suction cup  1830  comprises a Nitinol wire form (and elastomeric coating, or first and second layers  6000 ,  6002  of material) in a retracted or collapsed configuration. The distal end  720  of the engagement catheter  1810  is adjacent a tissue  1770  of interest.  FIG. 47  illustrates a cross-sectional view of a distal end  720  of an engagement catheter  1810 . In this embodiment, the engagement catheter  1810  is extended to deploy, expand, and/or inflate flute-shaped suction cup  1830 . The flute-shaped suction cup  1830  has engaged tissue  1770  and vacuum or suction is being applied to pull or vacuum tissue  1770  partially into flute-shaped suction cup  1830 , as shown in  FIG. 47 . 
       FIG. 48  illustrates a cross-sectional view of a distal end  720  of an engagement catheter  1810 . In this embodiment, the engagement catheter  1810  is extended to deploy, expand, and/or inflate flute-shaped suction cup  1830  and a dilation catheter  1840  (described further above with regard to  FIG. 38 ) is partially extended to further extend needle  1890  to puncture a tissue  1770  of interest. In one example, a tissue  1770  to be punctured may be the fossa ovalis. As can be seen in  FIG. 48 , the flute-shaped suction cup  1830  is applying suction or vacuum pressure to the fossa ovalis or tissue  1770 , thereby locking the engagement catheter  1810  to the fossa ovalis or tissue  1770  to facilitate puncturing and access through the fossa ovalis or tissue  1770 . 
       FIG. 49  illustrates a cross-sectional view of a distal end  720  of an engagement catheter  1810 . In this embodiment, the engagement catheter  1810  is extended to deploy, expand, and/or inflate flute-shaped suction cup  1830  and a dilation catheter  1840  (described further above with regard to  FIG. 38 ) is further extended through the wall of the tissue  1770  of interest, in preparation for delivery of additional catheters or other products such as a liquid, gas, or medication into the atrial or pericardial space. The guide wire  1050  is being advanced through the needle  1890  into the atrial or pericardial space to secure the point of entry and guide further insertion of dilation catheter  1840  or another catheter. In this example, the tissue  1770  to be punctured may be the fossa ovalis. As can be seen in  FIG. 49 , the flute-shaped suction cup  1830  is applying suction or vacuum pressure to the fossa ovalis or tissue  1770 , thereby locking the engagement catheter  1810  to the fossa ovalis or tissue  1770  to facilitate puncturing and access through the fossa ovalis or tissue  1770 . 
       FIG. 50  illustrates a perspective view of a flute-shaped suction cup  1830  of the present invention. In this embodiment, the structural vanes  6010  may comprise longitudinally disposed Nitinol spines having radiopaque markers  1902  positioned thereon. As shown in  FIG. 50 , the radiopaque markers  1902  may be positioned on the Nitinol structural vanes  6010  at the distal end  6100  of the flute-shaped suction cup  1830 . Alternatively, the radiopaque markers  1902  could be positioned at various locations on flute-shaped suction cup  1830  and any number, size or shape of radiopaque markers  1902  may be used. Use of radiopaque markers  1902  is very helpful for determining exact position of flute-shaped suction cup  1830  within a patient using x-ray imaging techniques.  FIGS. 51 &amp; 52  illustrate perspective views of the handle  1900  of an engagement catheter  1810  of the present invention.  FIG. 51  shows the handle  1900  configured to retract the engagement catheter  1810  using detents  1904  and locking pin  1906 .  FIG. 52  shows the handle  1900  configured to extend the engagement catheter  1810  using detent collet  1908 . 
       FIG. 53  illustrates a perspective view of the handle  1900  on the proximal end  710  of an engagement catheter  1810  of the present invention.  FIG. 53  shows the handle  1900  configured with the outer sheath  1800  extended and the flute-shaped suction cup  1830  in the collapsed configuration using locking pin  1906 .  FIG. 53  further illustrates use of a three-way stopcock  1910  or valve positioned on vacuum suction port  770  to help the user easily turn suction on and off during a procedure.  FIG. 54  illustrates a perspective view of the handle  1900  on the proximal end  710  of an engagement catheter  1810  of the present invention.  FIG. 54  shows the handle  1900  configured with the outer sheath  1800  retracted and the flute-shaped suction cup  1830  deployed. This embodiment illustrates a canted coil spring detent  1912 . Canted coil spring detents  1912  may comprise forward and backward detents (similar to detents  1904 ) for collapsing or expanding the suction cup  1830 .  FIG. 54  also illustrates use of a three-way stopcock or valve positioned on vacuum suction port  770  to help the user easily turn suction on and off during a procedure. 
       FIG. 55  illustrates a perspective view of the handle  1900  on the proximal end  710  of an engagement catheter  1810  of the present invention. This embodiment of the handle  1900  incorporates dual hemostasis seals  1914 . The dual hemostasis seals  1914  are sized to accommodate small guidewires, dilators, catheters, etc. while providing a tight sealing connection.  FIG. 56  illustrates an exemplary embodiment of an engagement catheter  1810  having a Nitinol cone-shaped suction cup  1830  disposed on its distal end  720  in a deployed configuration. Cone-shaped suction cups  1830  comprised of Nitinol or other shape memory material are further described herein above with reference to  FIGS. 17 and 18 . In the embodiment shown in  FIG. 56 , the cone-shaped suction cup  1830  has a plurality of longitudinally disposed thicker structural vanes  6010  which are disposed in an approximate zig-zagging configuration. The approximately zig-zag shaped vanes  6010  may have varying thicknesses, or a uniform thickness as shown in  FIG. 56 . The longitudinally disposed zig-zagging vanes  6010  are evenly disposed in a repeating pattern around the circumference of the suction cup  1830 .  FIG. 57  illustrates a perspective view of the handle  1900  on the proximal end  710  of an engagement catheter  1810  of the present invention having a thumb wheel  1916  for deploying and collapsing the suction cup  1830 . A user may spin the thumb wheel  1916  to control deployment of the suction cup  1830  at the distal end  720 . In some embodiments, the suction cup  1830  may be slowly deployed and in other embodiments it may be quickly deployed. In this manner, a user may also choose to only partially deploy the suction cup  1830 , if desired. A luer port  1924  positioned on proximal end of handle  1900  further provides guidewire and needle access. 
       FIG. 57  also illustrates a three-way stopcock  1910  operably coupled to handle  1900  for flushing engagement catheter  1810 . The three-way stopcock  1910  also provides vacuum or suction to suction cup  1830  via suction port  770 . The outer sheath  1800  may also be operably coupled to a separate three-way stopcock for flushing the outer sheath  1800 .  FIG. 58  illustrates a detachable handle  1900 , which is detachably coupled to the outer sheath  1800  via a removable handle locking pin  1918 . The handle locking pin  1918  may have an approximately U-shaped design and operably couples the outer sheath  1800  and handle  1900  together.  FIG. 57  illustrates the handle locking pin  1918  in place and  FIG. 58  illustrates the handle locking pin  1918  removed. In this embodiment, the handle locking pin  1918 , may be removed, such as by squeezing and pulling. Once the handle locking pin  1918  has been removed, the user can squeeze handle connection arms  1922 ,  1924  together to then pull the handle  1900  away from, and separate from, the outer sheath  1800 . Removal of the handle  1900  will also remove the dilator and suction cup  1830  from the patient, providing easier access to the outer sheath  1800  for catheters, guidewires, etc.  FIG. 58  also illustrates a three-way stopcock  1910  operably coupled to handle  1900  for flushing engagement catheter  1810 . The three-way stopcock  1910  also provides vacuum or suction to suction cup  1830  via suction port  770 . The outer sheath  1800  may also be operably coupled to a separate three-way stopcock for flushing the outer sheath  1800 . 
       FIG. 59  illustrates a perspective view of the proximal end  710  of an outer sheath design  1800  having a hemostasis valve (or dual valves)  1914  on the proximal end  720  thereof. The hemostasis seal(s)  1914  are sized to accommodate small guidewires, dilators, catheters, etc. while providing a tight sealing connection.  FIG. 59  also illustrates the three-way stopcock  1920  operably coupled to outer sheath  1800  for flushing the outer sheath  1800 .  FIG. 60  illustrates a perspective view of a flute or cone-shaped suction cup  1830  of the present invention with longitudinally disposed structural vanes  6010  arranged around the circumference of the suction cup  1830 . In this embodiment, the structural vanes  6010  may comprise wires formed of Nitinol. In this embodiment, the structural vanes  6010  may comprise longitudinally disposed Nitinol wires having loops connecting each longitudinally disposed vane at the distal end  6100  of the flute-shaped suction cup. The loops are connected at the distal end  6100  in a curving manner that looks similar to that of flower petals, as shown in  FIG. 60 . The wire Nitinol structural vanes  6010  may further be encapsulated in a flexible urethane or other similar deformable and/or collapsible material, such as first and second layers  6000 ,  6002  described herein above. 
       FIG. 61  illustrates the steps of using laser cutting and heat setting processes to form the collapsible Nitinol frame, or structural vane  6010  frame, of a fluted or cone-shaped suction cup  1830 . The process or method begins with a Nitinol tube  6200  having a diameter substantially similar to that of engagement catheter  1810 , because the proximal end  6102  of the cone-shaped suction cup  1830  will be disposed on, or coupled to, the distal end  720  of the engagement catheter  1810 . The proximal end  6102  of the Nitinol tube  6200  may be laser cut to form attachment slots  6500  to be used for coupling attachment to elongated catheter  1810 . These attachment slots  6500  may comprise several short elongate slots placed around the circumference of Nitinol tube  6200 . 
     As shown in  FIG. 61 , the Nitinol tube  6200  is also laser cut along its length at distal end  6100  to form slots  6300 , which define several longitudinal structural vanes  6010 . The Nitinol structural vanes  6010  themselves may be rounded at the distal ends  6100  and may further comprise additional cuts therein, such as to form elongated teardrop shaped cuts  6400  at their most distal ends  6100 . After laser cutting, the section of Nitinol tube  6200  having elongated cuts or slots  6300 ,  6400 , and  6500  therein, may then be heat set at 500° C.-550° C. to form the fluted, flared, or cone-shaped Nitinol structural vanes  6010 , best shown in  FIG. 62  (and the last image in  FIG. 61 ). These Nitinol structural vanes  6010  form a framework upon which an elastomeric cone-shaped suction cup  1830  will be formed. It should be understood that  FIGS. 61 and 62  are exemplary only for the purposes of illustration herein, and the number, size, and shape of cuts and/or slots  6300 ,  6400 , and  6500  and/or structural vanes  6010  may vary from those shown. 
       FIGS. 63 and 64  illustrate two embodiments having different Nitinol structural vane  6010  frame designs. The Nitinol structural vanes  6010  may be formed of either curved and/or straight structural vane  6010  shapes. The specific size and shape of the Nitinol structural vanes  6010  may be optimized for flexibility and strength through the disclosed laser cutting and heat setting processes herein. For example, the Nitinol structural vanes  6010  may be wider at the proximal end  6102  of the cone-shaped suction cup  1830  for strength, but may also have wider slots  6400  at the distal end of the in the Nitinol structural vanes  6010  for flexibility. Furthermore, the cross-sectional area of the Nitinol structural vanes  6010  may be reduced or increased along its length as needed to achieve the desired flexibility, strength, etc. As shown in  FIG. 63 , one embodiment of a Nitinol frame may be comprised entirely of curved Nitinol structural vanes  6010 , while another embodiment, shown in  FIG. 64 , may be comprised of both straight and curved Nitinol structural vanes  6010 . 
       FIG. 65  illustrates an embodiment of a cone-shaped suction cup  1830  formed by adding an elastomeric coating to the Nitinol structural vanes  6010 /frame. An elastomeric coating, such as polyurethane or silicone, may be disposed onto the Nitinol structural vanes  6010  to form the cone-shaped suction cup  1830 .  FIG. 66  illustrates two steps of using laser cutting and heat setting processes to form a spring shaped Nitinol structural vane frame. The process begins with a Nitinol tube  6200  laser cut into a spring or spiral shape and having a diameter substantially similar to that of engagement catheter  1810 , because the proximal end  6102  of the cone-shaped suction cup  1830  will be disposed on, or coupled to, the distal end  720  of an engagement catheter  1810 . After laser cutting, the Nitinol spring or spiral shaped tube  6200  may then be placed into a fixture or mold (described in more detail below) and heat set at 500° C.-550° C. to form the fluted, flared, or cone-shaped Nitinol structural vane  6010  frame, shown in  FIG. 66 . The Nitinol structural vane or vanes  6010  may form a spiral or spring-shaped and cone-shaped framework upon which an elastomeric coating or sealer may be applied to form cone-shaped suction cup  1830 . With reference now to the methods and processes of forming the cone-shaped suction cups  1830  herein, it should be understood that the elastomeric coating may be applied as two layers of film  6000 ,  6002  adhered together to form or define structural vanes  6010 ; or elastomeric coating may be applied as two layers of film  6000 ,  6002  adhered together over an already formed Nitinol structural vane  6010  frame; or elastomeric coating may be applied as a sealer or coating over an already formed Nitinol structural vane  6010  frame. Further, the figures herein are exemplary only for purposes of illustration and the exact number, sizes, and shapes of the Nitinol structural vanes  6010  and slots  6300 ,  6400 , or  6500  may be changed to adjust the strength, flexibility, and other desired characteristics of the cone-shaped suction cups  1830  desired. 
     The generally known methods of laser cutting and heat setting or shape setting of Nitinol are followed herein. Specifically, the laser cut Nitinol is put into a fixture or mold which forms and constrains it to the desired final shape. The Nitinol is then heated to the recommended 500° C. temperature for a minimum of 5 minutes in a furnace and then quenched with water to set the shape. The fixture or mold consists of a male side, a female side, and a clamp. The male said is an expansion mandrel that flares the Nitinol to the desired shape. The female side has a cavity on the inside that is an inverted shape of the male side plus the formed Nitinol. The clamp is used to compress the Nitinol between the male and female sides and hold them together with enough force to ensure it won&#39;t move during the heating cycle. 
     An exemplary method of operating the embodiments of engagement catheter  1810  having a flute-shaped suction cup  1830  on its distal end  720  disclosed herein will now be described. An exemplary method of engaging a tissue  1770  of interest to access a space adjacent thereto comprises the step of introducing the engagement catheter  1810  into a mammalian body so that at least part of the system is adjacent to a targeted tissue  1770 . The method may further comprise engaging the targeted tissue  1770  using flute-shaped suction cup  1830  of engagement catheter  1810  by applying a vacuum to the engagement catheter  1810  and piercing the targeted tissue  1770  using a needle  1890  to create a tissue aperture. Tissue engagement step may include, but is not limited to, engagement of an atrial wall to ultimately provide access to a pericardial space through an atrial aperture and engagement of an atrial septum to ultimately provide access to a left atrium through an atrial septum aperture, and or various other tissue engagements and/or access that may be possible using various embodiments of the present invention. 
     While various embodiments of devices and systems and methods for using the same have been described in considerable detail herein, the embodiments are merely offered as non-limiting examples of the disclosure described herein. It will therefore be understood that various changes and modifications may be made, and equivalents may be substituted for elements thereof, without departing from the scope of the present disclosure. The present disclosure is not intended to be exhaustive or limiting with respect to the content thereof. 
     Further, in describing representative embodiments, the present disclosure may have presented a method and/or a process as a particular sequence of steps. However, to the extent that the method or process does not rely on the particular order of steps set forth therein, the method or process should not be limited to the particular sequence of steps described, as other sequences of steps may be possible. Therefore, the particular order of the steps disclosed herein should not be construed as limitations of the present disclosure. In addition, disclosure directed to a method and/or process should not be limited to the performance of their steps in the order written. Such sequences may be varied and still remain within the scope of the present disclosure.