Abstract:
Disclose herein are embodiments related to a delivery system for performing a minimally invasive procedure, the system including one or more station legs configured to attach to an operating surface and a cross-beam connected to the one or more station legs and running from 0° to 45° relative to a top of the operating surface, wherein a distance between the operating surface and the cross-beam is adjustable. Additionally, an embodiment may have a first arm connected to the cross-beam, a second arm connected to the first arm, and an axial member connected to the second arm, the axial member comprising an axial joint. The delivery system may then be configured to advance to an internal target site using the axial joint while maintaining a stationary trajectory in relation to the internal target site with the delivery system trajectory is modifiable at the target site.

Description:
CROSS-REFERENCED TO RELATED APPLICATIONS 
       [0001]    The present application claims benefit of priority under 35 U.S.C. 119(e) to the filing date of U.S. Provisional Patent Application 63/367,190 filed Jul. 27, 2016, entitled, “STABILIZATION AND MANIPULATION OF A DELIVERY SYSTEM FOR A PERCUTANEOUS PROCEDURE,” the contents of which is incorporated herein by reference in their entirety. 
     
    
     BACKGROUND 
       [0002]    The present disclosure is generally related to a device and method of using a proximal area delivery system. 
         [0003]    Generally, percutaneous procedures relate to medical procedures by which internal organs or tissue are accessed via a needle-puncture of the skin rather than by using a more invasive approach by which internal organs or tissue are exposed. A percutaneous approach is typically used in vascular procedures (e.g., angioplasty and stenting). Percutaneous specifically refers to the access modality of a medical procedure, whereby a medical device is introduced into a patient&#39;s blood vessel via a needle stick. 
         [0004]    Functional mitral and/or tricuspid regurgitation (MR &amp; TR) are the most common type of valve pathologies and are usually associated with mitral valve disease (MVD). Currently, the majority of patients with both MR and TR require surgical treatment, but a large portion of the population does not receive treatment due to the high risk and complexity associated with invasive procedures (e.g., open heart surgery). 
         [0005]    Minimally invasive percutaneous treatments are being developed to address this need. The development process is ongoing. However, such processes can be generally characterized as treating structural heart diseases through a catheter to reduce the incidence of open heart surgical intervention. This not only provides a safer and more efficient treatment, but in many cases it is also the only form of treatment available, particularly for high risk patients. 
       SUMMARY 
       [0006]    In an embodiment, a delivery system for minimally invasive procedures includes one or more station legs configured to attach to an operating surface, a cross-beam connected to the one or more station legs and running parallel to a top of the operating surface, a first arm connected to the cross-beam, a second arm connected to the first arm, an axial connected to the second arm, the axial comprising an axial joint. The delivery system is configured to be advanced to an internal target site using the axial joint. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0007]    Aspects, features, benefits and advantages of the embodiments described herein will be apparent with regard to the following description, appended claims, and accompanying drawings where: 
           [0008]      FIG. 1  depicts a perspective view of an illustrative station according to an embodiment. 
           [0009]      FIG. 2  depicts an illustrative view of a connection of the station to an operating room bed according to an embodiment. 
           [0010]      FIG. 3  depicts a detail view of an illustrative bed rail according to an embodiment. 
           [0011]      FIG. 4  depicts a detail view of an illustrative station leg, connecting block, and bed rail according to an embodiment. 
           [0012]      FIG. 5  depicts a detail view of an illustrative connecting block according to an embodiment. 
           [0013]      FIG. 6  depicts a perspective view of an illustrative cross beam and arm connection according to an embodiment. 
           [0014]      FIG. 7  depicts a detail view of an illustrative cross beam and station leg connection according to an embodiment. 
           [0015]      FIG. 8  depicts a view of an illustrative connection of a cross beam and arm connection according to an embodiment. 
           [0016]      FIG. 9  depicts another view of an illustrative connection of a cross beam and arm connection according to an embodiment. 
           [0017]      FIG. 10  depicts a view of an illustrative connection of a short arm and a long arm according to an embodiment. 
           [0018]      FIG. 11  depicts another view of an illustrative connection of a short arm and a long arm according to an embodiment. 
           [0019]      FIG. 12  depicts a view of an illustrative discrete rotation joint according to an embodiment. 
           [0020]      FIG. 13  depicts a view of another illustrative discrete rotation joint according to an embodiment. 
           [0021]      FIG. 14  depicts a view of an illustrative connection of an axial member with a short arm according to an embodiment. 
           [0022]      FIG. 15  depicts a view of an illustrative axial member according to an embodiment. 
           [0023]      FIG. 16  depicts a detail view of an illustrative axial connecting area according to an embodiment. 
           [0024]      FIG. 17  depicts detail view of an illustrative axial main knob according to an embodiment. 
           [0025]      FIG. 18  depicts a perspective view of an illustrative support arm according to an embodiment. 
           [0026]      FIG. 19  depicts another perspective view of an illustrative support arm according to an embodiment. 
           [0027]      FIG. 20  depicts a detail view of an illustrative ball joint and axial plate connector according to an embodiment. 
           [0028]      FIG. 21  depicts a detail view of an illustrative ball joint and an operating room bed attachment according to an embodiment. 
           [0029]      FIG. 22  depicts a detail view of an illustrative operating room bed attachment according to an embodiment. 
           [0030]      FIG. 23  depicts a view of an illustrative connection between a support arm and an axial member according to an embodiment. 
           [0031]      FIG. 24  depicts a view of another illustrative connection between a support arm and an axial member according to an embodiment. 
           [0032]      FIG. 25  depicts a view of an illustrative connection of a delivery system and an axial member according to an embodiment. 
           [0033]      FIG. 26  depicts a view of an illustrative distal end of an axial member connecting bar according to an embodiment. 
           [0034]      FIG. 27  depicts a view of an illustrative interface with a delivery system according to an embodiment. 
           [0035]      FIG. 28  depicts a view of an illustrative clamp mechanism according to an embodiment. 
           [0036]      FIG. 29  depicts a view of an illustrative axial member and ball joint according to an embodiment. 
           [0037]      FIG. 30  depicts a view of an illustrative ball joint according to an embodiment. 
           [0038]      FIG. 31  depicts a view of an illustrative friction rotation joint according to an embodiment. 
           [0039]      FIG. 32  depicts a view of an illustrative rotation joint plate according to an embodiment. 
           [0040]      FIG. 33  depicts a view of an illustrative rotational joint cone according to an embodiment. 
       
    
    
     DETAILED DESCRIPTION 
       [0041]    This disclosure is not limited to the particular systems, devices and methods described, as these may vary. The terminology used in the description is for the purpose of describing the particular versions or embodiments only, and is not intended to limit the scope. 
         [0042]    As used in this document, the singular forms “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise. Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art. Nothing in this disclosure is to be construed as an admission that the embodiments described in this disclosure are not entitled to antedate such disclosure by virtue of prior invention. As used in this document, the term “comprising” means “including, but not limited to.” 
         [0043]    As discussed, embodiments herein relate to an accessory device and method that may utilize a rack and rail system with linear and rotational joints to allow for the implementation of a delivery system in a proximal area of the target region (e.g., within one or more heart chambers). An embodiment may provide stabilization, orientation, and fixation of the delivery system within a predefined point or area in space. The delivery system may also have a specific orientation according to the orientation and anatomy of a specific patient. 
         [0044]    Thus, an embodiment may include a delivery station for introduction of an implant. A non-limiting specific example may include a semi rigid, D-shaped annuloplasty ring used for treatment of mitral and/or tricuspid regurgitation. In one embodiment, the station may comprise a metal frame composed of several racks, rails, and metal plates. The metal frame may enable manipulation of a distal end of the station to any desired location, while also allowing for precise orientation of the distal end with regard to the target (e.g., the heart). 
         [0045]    As would be understood by one skilled in the art, the station may be constructed of various materials and/or material alloys. Moreover, different components of the station may be independently manufactured from different materials and/or material alloys. By way of specific non-limiting example, a station could be constructed of aluminum, stainless steel, polymers, synthetic compounds, semi-synthetic compounds, or any other material that would provide sufficient operational strength. It should be further understood that the joints discussed herein could be comprised of metal and/or polymer components. 
         [0046]    Another embodiment may include linear joints that allow translation in the X, Y, or Z axes. The joints may be constructed of sliding bearings with or without rails that are actuated manually or automatically (e.g., motorized automation). Accordingly, the rails may be motorized while also giving a user the ability to manually adjust the rails if desired. In an embodiment, the motorization of the segments may be performed using various techniques (e.g., electrical motors, pneumatic motors, electrical pistons, pneumatic pistons, electromagnets, etc.) or combinations of various techniques. 
         [0047]    A further embodiment may include rotational joints. These rotational joints may enable rotation of the distal end of the station around any of the axes (e.g., X, Y, and Z), and thus provide all six degrees of freedom required to be able to bring the distal end of the delivery station to any desired point. This allows a user to align the distal end with any point in space, allowing access to the target site. The delivery system (DS) may be aligned in any desired orientation with respect to the target site as well. 
         [0048]    In addition to the wide ranges of motion discussed herein, an embodiment may also have the ability to delicately advance the DS into the target (e.g., within the heart chamber) by use of an axial joint and/or a ball joint. The axial joint may allow advancement and retraction of the DS within the target site in a specific direction of the DS. The ball joint may allow the operator to manipulate the vector of the DS within the target (e.g., heart chamber). 
         [0049]    The illustrated example embodiment will be best understood by reference to the figures. The following description is intended only by way of example, and simply illustrates certain example embodiments. 
         [0050]      FIG. 1  shows a perspective view of an illustrative station  100 . In one embodiment, the station  100  may comprise a distal end  101 , an operating room bed  110 , operating room bed rail  111 , station legs  120  and  121 , one or more connecting blocks  122 , a station cross beam  130 , a long (e.g., 1000 mm) station arm  140 , a short (e.g., 500 mm) station arm  150 , an axial member  160 , and a support arm  170 . The station legs  120  and  121  may be arranged in the z-axis of the station  100  to allow the station to connect to the operating room bed via one or more connecting blocks, such as  122 . In one embodiment, the axial member  160  helps impart inferior and superior movement within the target site (e.g., the heart) as well as y-axis rotation. Additionally, in another embodiment, the support arm  170  may provide stability as shown in  FIGS. 23-24 . 
         [0051]    The station  100 , as discussed, may be made using various materials. For simplicity the station  100  or frame may be referred to herein as metal. However, it should be understood by those skilled in the art that this language is only for simplicity of explanation purposes, and, as discussed, the station  100  may be manufactured out of various materials and various combinations of materials. Thus, an embodiment may have a metal frame in combination with translational and rotational joints that allow the delivery system to be controlled and positioned to a desired location with a desired orientation. Using the joints, an embodiment may move and relocate the distal end  101  of the system in any X, Y, and Z coordinate plane in order to access the desired area of the patient (e.g., the patient&#39;s chest), and position the distal end  101  in any vector, specifically towards the intended target (e.g., the mitral valve from the X, Y, and Z coordinate). An embodiment, may also allow translation in the X, Y, and Z directions along linear lines as well as rotation of the attachment point around the X, Y, and Z axes (e.g., like a ball joint). 
         [0052]    In one embodiment, the attachment of the station legs  120  and  121  to an operating room or catheterization laboratory bed  110  may be done via operating room bed rails  111 . The operating room bed rails  111  may be permanently attached to the operating room bed  110  or interchangeable. In one embodiment, movement of the distal end  101  in the z-axis may be from about 200 mm to about 900 mm above the operating room bed  110 . 
         [0053]    In one embodiment, the station  100  may be used in a sterile field and be used as a sterilized unit after sterilization (e.g., in an autoclave or using the ethylene oxide (ETO) process). Additionally or alternatively, different individual components may be draped on or around the system in order to maintain sterility while other components can be sterilized according to the operator&#39;s requirements. 
         [0054]    Referring to  FIG. 2 , an illustrative connection of the station  100  to the operating room bed is illustrated. In one embodiment, the example connection may include a station cross beam  130 , station legs  120  or  121 , a connecting block  122 , and an operating room bed rail  111 . In the depicted embodiment, the station legs  120  or  121  are attached via a connecting block  122 . As shown in  FIG. 2 , a station leg  120  (or, alternatively,  121 ) may connect to an operating bed  110  using the connecting block  122  via a bed rail  111 . Thus, in one embodiment, a connecting block  122  may be used to fasten a station leg  120  to the operating bed. 
         [0055]    Further detail regarding the operating room bed rail  111  is shown in  FIG. 3 . In one embodiment, and as shown in  FIG. 3 , the width of the operating room bed rail  111  may be in a range of about 5 mm to about 15 mm, and the height of the operating room bed rail  111  may be in a range of about 12 mm to about 30 mm. Referring now to  FIG. 4 , an enlarged illustration of an illustrative connecting block  122  is shown. In one embodiment, as shown in  FIG. 4 , the connecting block  122  may be attached to a station leg  120  using one or more screws  124  (see  FIG. 5 ) and may be attached to the operating room bed rail  111  using a clamp system that adjusts to fit a variety of bed rail sizes, as discussed herein and shown in  FIG. 3 . 
         [0056]    As shown in  FIG. 5 , a connecting block  122  may include a tightening block  123 , one or more screws  124 , and a threaded device  125 . The tightening block  123  may be tightened or closed to secure the connection between a station leg  120  (or, alternatively,  121 ) and  121  and an operating room bed rail  111 . In one embodiment, the connecting block  122  may use, for example, a threaded device  125 . When the connecting block  122  is closed, an embodiment may lock the leg  120  into a particular position with minimal to no relative movement between the leg(s) and the rail  111  or bed  110 . 
         [0057]    Securing alignment of the station  100  in the z-axis may be performed using an attachment mechanism to connect a station leg  120  to a connecting block  122  (e.g., via screws  124  ( FIG. 5 ) or other fastening hardware). Additionally or alternatively, an embodiment may attach via a rail system with a continuous or discrete lock. This may allow for a more refined alignment of the z-axis using the connection block  122 . 
         [0058]    Referring now to  FIG. 6 , an illustrative station cross beam  130  and arms  140  and  150  are shown. In one embodiment, the station cross beam  130  and arms  140  and  150  may include a right station leg  120 , a left station leg  121 , a station cross beam  130 , a long (e.g., 1000 mm) station arm  140 , a short (e.g., 500 mm) station arm  150 , and an axial member  160 . In one embodiment, the right station leg  120  and left station leg  121  may be in the z-axis of the station  100 , and the station cross beam  130  may be in the x-axis of the station. As discussed herein, in an embodiment, a long station arm  140  may be located in the y-axis of the system, and a short station arm  150  may have y-axis and x-axis rotation. Additionally, an axial member  160  may have inferior and superior movement within the target site (e.g., the heart) and a rotational axis around the y-axis. 
         [0059]    Referring to  FIG. 7 , an illustrative connection between a station cross beam  130  and a station leg  120  is shown. In one embodiment, the attachment of the station cross beam  130  to the station leg  120  may be via a 90 degree plate  126 , where the plate may be made of various materials (e.g., a metal, stainless steel, aluminum, etc.) that attach the station leg to the station cross beam via screws  127  and  127 . Additionally or alternatively, this connection (i.e., the connection between the station cross beam  130  and the station leg  120  may be formed using a rail system with a discrete or continuous locking mechanism(s) to allow for smooth movement. In a further embodiment, the movement of the connection may be performed using various techniques (e.g., electrical motors, pneumatic motors, electrical pistons, pneumatic pistons, electromagnets, etc.) or a combination of the various techniques. This electro/mechanical movement allows control over the movement of the station cross beam  130  in the z-axis of the system. 
         [0060]    Referring now to  FIG. 8 , an illustrative connection between a station cross beam  130  and at least one station arm  140  and  150  is shown. In one embodiment, the connection may include a lower rail  131 , an upper rail  132 , one or more rail stoppers  133 , a cross beam x-axis lock feature  134 , and a rider(s)  135 . In one embodiment, the station cross beam  130  may be the main beam of the station  100  and run parallel to the x-axis ( FIG. 1 ). Thus, the station cross beam  130  allows full control over the location of the distal end  101  of the station  100  in the x-axis. 
         [0061]    In a further embodiment, movement of the long station arm  140  along the station cross beam  130  in the x-axis may be performed using a rail system (e.g., one rail, two rails, three rails, etc.)  131  and  132  that is attached to the station cross beam. In one embodiment, the station arms  140  and  150  are attached to rider(s)  135 , and the rider(s) move on the station cross beam  130 . In a further embodiment, the movement of the rider(s)  135  may be restricted via a cross beam x-axis lock feature  134 , which may lock the arms in a fixed position. Thus, an embodiment may require the opening of the cross beam x-axis lock feature  134  in order for any movement in the x-axis to take place. 
         [0062]    In another embodiment, multiple riders (e.g., one, two, three, etc.)  135  may be attached to a single rail within the rail system (e.g., in parallel or series). The use of multiple riders  135  attached to one another is designed to provide increased stability and minimal movement when a load is applied to the distal end  101  of the station  100 . In a further embodiment, the station cross beam  130  width may be smaller (e.g., 500 mm, 600 mm, 700 mm, etc.) for narrow operating room beds, and larger (e.g., 1300 mm, 1400 mm, 1500 mm, etc.) for wide operating room beds. 
         [0063]    Referring now to  FIG. 9 , an illustrative station arm (e.g., the long station arm  140 ) and station cross beam  130  beam connection is shown. In one embodiment, the station arm (e.g., the long station arm  140 ) may include a long arm y-axis rail  141 , a cross beam y-axis movement lock  142 , a y-axis rider  143 , and a plate (e.g., a metal, stainless steel, aluminum, etc.)  146 . In another embodiment, the station cross beam  130  may include a cross beam x-axis lock feature  134 , one or more x-axis rider(s)  135 , and a plate (e.g., a metal, stainless steel, aluminum, etc.)  136 . The station cross beam  130  attachment to the long station arm  140  may be done via various parts (e.g., plates  136  and  146 , rider(s)  135  and  143 , and locking features  142  and  134 ). 
         [0064]    Thus, in one embodiment, the rider(s)  135  and  143  may connect via a plate  136  and  146 , which, in turn, is connected on one side to the long station arm  140 . The plates  136  and  146  may also contact the cross beam upper rail  132  on the other side. In addition, a plate  136  may be connected to a rider(s)  135  that is attached to the lower rail  131 . In one embodiment, the two plates  136  and  146  may be attached via a third metal plate ( 147  see  FIG. 8 ). The third metal plate  147  provides not only a connection to the first two plates (e.g., metal plates) but also stability. The third metal plate  147  also helps to minimize any movement of the long station arms  140  when the locks features  134  and  142  are in the closed configuration. 
         [0065]    Another embodiment, as shown in  FIGS. 10-13 , allows rotational joint movement between two arms (e.g., the short arm and the long arm). An embodiment that utilizes a rotational joint may include a long station arm  140 , a short station arm  150 , a short arm rail  151 , a short arm locking feature  152 , a short arm rider  153 , a short arm rack  154 , a discrete rotation joint  155 , and a plunger/locking pin  156 . In a further embodiment, the discrete rotation joint  155  may be affixed to the long station arm  140  via one or more screws  158  placed in one or more recessed cavities  159 . 
         [0066]    In one embodiment, the discrete rotation joint  155  is normally locked in a fixed position by a pivot pin on a plunger/locking pin  156 . When an operator wishes to rotate the short station arm  150 , the operator may operate the plunger/locking pin  156  (e.g., pull the plunger pin out of the locking hole(s)  190  it is currently in) to rotate the short station arm  150  and re-lock it into one of the locking hole(s). The locking plate  157  can be attached to the short station arm  150  in different orientations that are set according to the one or more recessed cavities  159  selected. It should be understood, that the figures are for illustrative purposes only, and thus although only two cavities are shown in  FIG. 13 , an embodiment may have more or fewer depending on the desired flexibility. In one embodiment, the combination of locking plate  157  orientation and selection of locking hole(s)  190  can allow for 270 degrees of movement in the short station arm  150 . 
         [0067]    In another embodiment, the short station arm  150  may be moved along the short arm rail  151  by opening the short arm locking feature  152 , moving the rail using the short arm rider  153 , and closing the short arm locking feature  152 . Additionally or alternatively, an embodiment may move the short station arm  150  using various other techniques (e.g., electrical motors, pneumatic motors, electrical pistons, pneumatic pistons, electromagnets, etc.) or combinations of various techniques. In addition, a discrete locking feature may be added to ensure that the arm is in a locked position as long as the discrete locking feature is not pulled out of location. 
         [0068]    Referring now to  FIG. 14 , an illustrative axial connection with the short station arm  150  is shown. In one embodiment, the connection may include a short station arm  150 , a short arm rail  151 , a short arm locking feature  152 , a short arm rider  153 , a discrete rotation joint  155 , an axial member  160 , an axial connector  161 , an axial to short arm connecting area  163 , a support arm attachment plate  166 , and an axial connecting bar  167 . As discussed herein, an embodiment may allow for movement of the axial member  160  using the discrete rotation joint  155  (e.g., rotational movement) and the short arm rider  153  as well as various other devices not pictured in  FIG. 14 , but discussed herein. 
         [0069]    Now referring to  FIG. 15 , an illustrative example of an axial member  160  is shown. In one embodiment, an axial member  100  may include an axial to short arm connecting area  163 , an axial main knob  164 , an axial rail  165 , an axial connecting bar  167 , an axial connecting bar distal end  168 , and an axial bar locking screw  169 . As discussed herein, the axial member has a large range of movement that allows the distal end  101  of the station  100  to be positioned with the best possible access to the target site as well as inside the target (e.g., the heart chamber). 
         [0070]    In one embodiment, the movement may be performed by rotating the axial main knob  164  (e.g., clockwise), which may cause the connecting bar  167  to move in a direction along the axial rail  165 . The connecting bar  167  may move in both directions along the axial rail  165  based on the direction in which the axial main knob  164  is rotated (e.g., clockwise rotation mat move the bar up, and counter-clockwise rotation may move the bar down). A more detailed view of an illustrative axial main knob  164  in conjunction with the axial member  160  is shown in  FIG. 17 . 
         [0071]    The attachment of the axial member  160  to the short station arm  150  may be formed using a connecting feature (e.g., the axial to short arm connecting area  163 ). In one embodiment, the connecting feature may be a plate attached with screws to the short station arm  150 , such as is shown in  FIG. 15 . Additionally or alternatively, the attachment may be made directly or through drapes in order to increase sterility. A more detailed view of an illustrative connecting feature, specifically an axial to short station arm  150  connecting area  163 , is shown in  FIG. 16 . 
         [0072]    In another embodiment, the stroke of the axial member  160  may be in the range of about 40 mm to about 600 mm. Thus, it may be used in combination with the movement of the short station arm  150  and the axial member  160  by aligning them and moving them in the same direction. The axial movement can be performed manually or using various techniques (e.g., electrical motors, pneumatic motors, electrical pistons, pneumatic pistons, electromagnets, etc.) or combinations of various techniques. 
         [0073]    Now referring to  FIG. 18 , an illustrative example of a support arm  170  is shown. In one embodiment, a support arm  170  may include a ball joint  171 , an operating room bed attachment  172 , a support arm lock knob  173 , and an axial plate connection  174 .  FIGS. 18-24  illustrate embodiments of a support arm  170 . In one embodiment, the support arm  170  may provide additional support to the station  100 . It is critical that equipment used during invasive procedures have minimal to no movement in order to ensure the safety of the patient. Thus, an embodiment may utilize the support arm  170  to ensure that minimal movement is imparted to the delivery system during the performance of any clinical procedure (e.g., a structural heart procedure). In a further embodiment, the station  100  may have more than one support arm  170  to increase stability of the distal end  101 . 
         [0074]    Turning now to  FIG. 22 , an illustrative operating room bed attachment  172  is shown. In one embodiment, attachment of the support arm  170  to the operating room bed may be performed using the operating room bed attachment  172  that fits (e.g., is specifically designed for) a particular operating room bed rail  111 . As discussed herein, the operating room bed rail  111  may have a width in the range of about 5 mm to about 15 mm and a height in the range of about 12 mm to about 30 mm (as shown in  FIG. 3 ). Locking the operating room bed attachment  172  to the operating room bed rail  111  may be performed by tightening a support arm connecting block  175  using a threaded screw system  176 . However, it should be understood that the illustration in  FIG. 22  is only one possible embodiment and that various other embodiments may be used (e.g., using a clamp (see  FIG. 29 ) or other method that will lock it into a fixed position). 
         [0075]    Brief reference will now be made to  FIGS. 23 and 24 . In order to ensure proper stability of the axial member  160 , an embodiment may attach the support arm  170  to the axial using the axial plate connection  174 . The axial plate connection  174  may be directly connected to the support arm attachment plate  166 , as shown in  FIGS. 23 and 24 . In one embodiment, the connection may be direct, as discussed, as long as both parts are sterile. Additionally or alternatively, the connection  174  between the axial plate and the support arm attachment plate  166  may be through a drape if either of the components is not sterile. 
         [0076]    In  FIG. 25 , an illustrative connection between a delivery system (DS) and an axial member  160  is shown. In one embodiment, the connection may include an axial connector knob  202 , an axial connecting bar  167 , an axial distal end bar connector  201 , and an axial bar locking screw  169 .  FIGS. 25-27  show further details and embodiments of the delivery system and axial member connection. The connection may be formed by attaching a ball joint that is part of the delivery system attached to the axial connector  161  to the axial connecting bar distal end  168  during a procedure. In one embodiment, this attachment is performed by closing the axial connector knob  202  and locking the axial bar locking screw  169 . Additionally, when the delivery system is centralized in the ball joint mechanism, the delivery system, the short station arm  150 , and the axial member  160  are moving in the same direction. Additional details regarding potential embodiments may be found in  FIGS. 28-34 . 
         [0077]    In the above detailed description, reference is made to the accompanying drawings, which form a part hereof. In the drawings, similar symbols typically identify similar components, unless context dictates otherwise. The illustrative embodiments described in the detailed description, drawings, and claims are not meant to be limiting. Other embodiments may be used, and other changes may be made, without departing from the spirit or scope of the subject matter presented herein. It will be readily understood that the aspects of the present disclosure, as generally described herein, and illustrated in the Figures, can be arranged, substituted, combined, separated, and designed in a wide variety of different configurations, all of which are explicitly contemplated herein. 
         [0078]    The present disclosure is not to be limited in terms of the particular embodiments described in this application, which are intended as illustrations of various aspects. Many modifications and variations can be made without departing from its spirit and scope, as will be apparent to those skilled in the art. Functionally equivalent methods and apparatuses within the scope of the disclosure, in addition to those enumerated herein, will be apparent to those skilled in the art from the foregoing descriptions. Such modifications and variations are intended to fall within the scope of the appended claims. The present disclosure is to be limited only by the terms of the appended claims, along with the full scope of equivalents to which such claims are entitled. It is to be understood that this disclosure is not limited to particular methods, reagents, compounds, compositions or biological systems, which can, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting. 
         [0079]    With respect to the use of substantially any plural and/or singular terms herein, those having skill in the art can translate from the plural to the singular and/or from the singular to the plural as is appropriate to the context and/or application. The various singular/plural permutations may be expressly set forth herein for sake of clarity. 
         [0080]    It will be understood by those within the art that, in general, terms used herein, and especially in the appended claims (for example, bodies of the appended claims) are generally intended as “open” terms (for example, the term “including” should be interpreted as “including but not limited to,” the term “having” should be interpreted as “having at least,” the term “includes” should be interpreted as “includes but is not limited to,” et cetera). While various compositions, methods, and devices are described in terms of “comprising” various components or steps (interpreted as meaning “including, but not limited to”), the compositions, methods, and devices can also “consist essentially of” or “consist of” the various components and steps, and such terminology should be interpreted as defining essentially closed-member groups. It will be further understood by those within the art that if a specific number of an introduced claim recitation is intended, such an intent will be explicitly recited in the claim, and in the absence of such recitation no such intent is present. 
         [0081]    For example, as an aid to understanding, the following appended claims may contain usage of the introductory phrases “at least one” and “one or more” to introduce claim recitations. However, the use of such phrases should not be construed to imply that the introduction of a claim recitation by the indefinite articles “a” or “an” limits any particular claim containing such introduced claim recitation to embodiments containing only one such recitation, even when the same claim includes the introductory phrases “one or more” or “at least one” and indefinite articles such as “a” or “an” (for example, “a” and/or “an” should be interpreted to mean “at least one” or “one or more”); the same holds true for the use of definite articles used to introduce claim recitations. 
         [0082]    In addition, even if a specific number of an introduced claim recitation is explicitly recited, those skilled in the art will recognize that such recitation should be interpreted to mean at least the recited number (for example, the bare recitation of “two recitations,” without other modifiers, means at least two recitations, or two or more recitations). Furthermore, in those instances where a convention analogous to “at least one of A, B, and C, et cetera” is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (for example, “a system having at least one of A, B, and C” would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B, and C together, et cetera). In those instances where a convention analogous to “at least one of A, B, or C, et cetera” is used, in general such a construction is intended in the sense one having skill in the art would understand the convention (for example, “a system having at least one of A, B, or C” would include but not be limited to systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B, and C together, et cetera). It will be further understood by those within the art that virtually any disjunctive word and/or phrase presenting two or more alternative terms, whether in the description, claims, or drawings, should be understood to contemplate the possibilities of including one of the terms, either of the terms, or both terms. For example, the phrase “A or B” will be understood to include the possibilities of “A” or “B” or “A and B.” 
         [0083]    In addition, where features or aspects of the disclosure are described in terms of Markush groups, those skilled in the art will recognize that the disclosure is also thereby described in terms of any individual member or subgroup of members of the Markush group. 
         [0084]    As will be understood by one skilled in the art, for any and all purposes, such as in terms of providing a written description, all ranges disclosed herein also encompass any and all possible subranges and combinations of subranges thereof. Any listed range can be easily recognized as sufficiently describing and enabling the same range being broken down into at least equal halves, thirds, quarters, fifths, tenths, et cetera. As a non-limiting example, each range discussed herein can be readily broken down into a lower third, middle third and upper third, et cetera. As will also be understood by one skilled in the art all language such as “up to,” “at least,” and the like include the number recited and refer to ranges that can be subsequently broken down into subranges as discussed above. Finally, as will be understood by one skilled in the art, a range includes each individual member. Thus, for example, a group having 1-3 cells refers to groups having 1, 2, or 3 cells. Similarly, a group having 1-5 cells refers to groups having 1, 2, 3, 4, or 5 cells, and so forth. 
         [0085]    Various of the above-disclosed and other features and functions, or alternatives thereof, may be combined into many other different systems or applications. Various presently unforeseen or unanticipated alternatives, modifications, variations or improvements therein may be subsequently made by those skilled in the art, each of which is also intended to be encompassed by the disclosed embodiments.