Abstract:
A visualization device for use with a loading tray includes a frame comprising a floor, a first side wall extending generally perpendicular from the floor, and a second side wall extending generally perpendicular from the floor and spaced from the first side wall. The visualization device further includes a mirror abutting the floor of the frame. A magnifying glass may also be supported by top edges of the first and second side walls, or by runners coupled to the top edges of the first and second side walls. The visualization device may be slideably disposed in a reservoir of a loading tray.

Description:
FIELD OF THE INVENTION 
     The present invention relates to catheter assemblies, loading trays, and methods of loading a catheter assembly. More specifically, the present invention relates to a visualization glass device for loading trays that improves the process of loading a medical device on a catheter assembly. 
     BACKGROUND 
     Heart valves, such as the mitral, tricuspid, aortic, and pulmonary valves, are sometimes damaged by disease or by aging, resulting in problems with the proper functioning of the valve. Heart valve problems generally take one of two forms: stenosis in which a valve does not open completely or the opening is too small, resulting in restricted blood flow; or insufficiency in which blood leaks backward across a valve when it should be closed. 
     Heart valve replacement has become a routine surgical procedure for patients suffering from valve regurgitation or stenotic calcification of the leaflets. Conventionally, the vast majority of valve replacements entail full stenotomy in placing the patient on cardiopulmonary bypass. Traditional open surgery inflicts significant patient trauma and discomfort, requires extensive recuperation times, and may result in life-threatening complications. 
     To address these concerns, within the last decade, efforts have been made to perform cardiac valve replacements using minimally-invasive techniques. In these methods, laparoscopic instruments are employed to make small openings through the patient&#39;s ribs to provide access to the heart. While considerable effort has been devoted to such techniques, widespread acceptance has been limited by the clinician&#39;s ability to access only certain regions of the heart using laparoscopic instruments. 
     Still other efforts have been focused upon percutaneous transcatheter (or transluminal) delivery of replacement cardiac valves to solve the problems presented by traditional open surgery and minimally-invasive surgical methods. In such methods, a valve prosthesis is compacted for delivery in a catheter and then advanced, for example through an opening in the femoral artery and through the descending aorta to the heart, where the prosthesis is then deployed in the valve annulus (e.g., the aortic valve annulus). 
     Valve prostheses are generally formed by attaching a bioprosthetic valve to a frame made of a wire or a network of wires. Such a valve prosthesis can be contracted radially to introduce the valve prosthesis into the body of the patient percutaneously through a catheter. The valve prosthesis can be deployed by radially expanding it once positioned at the desired target site. The valve prosthesis is mounted onto a distal tip of the catheter assembly prior to delivery to the target location where the valve prosthesis is expanded into place. 
     To prepare such a valve prosthesis for implantation, the valve prosthesis can be initially provided in an expanded or uncrimped condition, then crimped or compressed around the distal tip of the catheter assembly until the valve prosthesis is as close to the diameter of the distal tip as possible. Various methods and devices are available for crimping the valve prosthesis onto the catheter&#39;s distal tip, which may include hand-held devices or tabletop devices, for example. These crimping devices can initially provide an opening that is large enough to accommodate a valve prosthesis in its expanded condition and be positioned over a desired section of a distal tip of the catheter assembly. The valve prosthesis can then be compressed by reconfiguring the opening of the crimping device to uniformly decrease the size of the opening until the valve is compressed to the desired size. Due to the bioprosthetic valve, the valve prosthesis often is not shipped loaded into the delivery catheter. Instead, many trancatheter valve prostheses must be loaded into the catheter assembly by hand at the treatment facility (e.g., operating room) immediately prior to performance of the procedure. 
     Many transcatheter valve prostheses and corresponding catheter assemblies have connection or attachment points that the user/loader must ensure are connected during the loading procedure. If the connection points are not properly connected, there is a risk of premature detachment of the valve prosthesis from the catheter assembly. The user/loader may also need to observe that certain portions of the valve prosthesis are properly loaded into the catheter assembly. The connection points and other portions of the valve prosthesis which need to be observed during loading may be located at several locations around the circumference of the catheter assembly. For example, two connection points where the proximal (outflow) end of the valve prosthesis is connected to the catheter assembly may be disposed on opposite sides of the valve prosthesis. Further, the valve prosthesis is normally loaded in a liquid solution such as, but not limited to, a saline solution. Thus, a loading tray filled with such a liquid solution is often used for loading a valve prosthesis on a catheter assembly. The catheter assembly in some cases may be held in place by the loading tray or other devices while loading the valve prosthesis. Thus, in order to ensure that the connections and/or other observations on opposite sides of the catheter assembly are properly connected/observed, the catheter assembly and valve prosthesis must either be lifted out of the liquid solution and twisted, or the loader must try to make the connections without seeing all of the connections. Removing the valve prosthesis and catheter assembly out of the liquid solution during loading may introduce unwanted air bubbles into the assembly. Further, twisting the catheter assembly may damage the catheter assembly or the valve prosthesis. 
     According, there is a need for a device that allows the loader to observe all sides of the catheter assembly and prosthetic valve during loading of the prosthetic valve onto the catheter assembly. 
     SUMMARY OF THE INVENTION 
     Embodiments hereof relate to a visualization device for use with a loading tray. The visualization device includes a frame comprising a floor, a first side wall extending generally perpendicular from the floor, and a second side wall extending generally perpendicular from the floor and spaced from the first side wall. The visualization device further includes a mirror abutting the floor of the frame. A magnifying glass may also be supported by top edges of the first and second side walls, or by support runners coupled to the top edges of the first and second side walls. 
     Embodiments hereof also relate to a tray for loading a medical device on a catheter assembly. The loading tray includes a reservoir defined by a bottom surface, a first wall, a second wall, a third wall, a fourth wall, and a generally open top opposite the bottom surface. A mirror abuts the bottom surface of the reservoir and faces the open top. A magnifying glass may be supported by the top edges of the first and third walls of the reservoir. 
     Embodiments hereof also relate to a tray for loading a medical device on a catheter assembly. The loading tray includes a reservoir defined by a bottom surface, a first wall, a second wall, a third wall, a fourth wall, and a generally open top opposite the bottom surface. A frame is slideably disposed in the reservoir. The frame includes a floor abutting the bottom surface of the reservoir. The frame also includes a first side wall attached to the floor and extending generally perpendicular from the floor. The first side wall of the frame abuts the first wall of the reservoir. The frame also includes a second side wall attached to and extending generally perpendicular from the floor. The second side wall of the frame abuts the third wall of the reservoir. A mirror is coupled to the floor of the frame and faces the open top of the reservoir. A magnifying glass may also be supported by top edges of the first and second side walls of the frame, or by support runners coupled to the top edges of the first and second side walls of the frame. 
    
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
         FIG. 1  is schematic diagram of a catheter assembly for delivering a transcatheter prosthetic heart valve to an implantation site, with the transcatheter heart valve prosthesis loaded in the catheter assembly. 
         FIG. 2  is an exploded perspective view of a catheter assembly and a loading tray with visualization device disposed in the loading tray. 
         FIG. 3  is a perspective view of an embodiment of a visualization device. 
         FIG. 4  is an exploded perspective view of a catheter assembly and a loading tray with another embodiment of a visualization device disposed in the loading tray. 
         FIG. 5  is a top view of the loading tray of  FIG. 4 . 
         FIG. 6  is a perspective view of a portion of a catheter assembly with a heart valve prosthesis being loaded therein as seen through a visualization device as described herein. 
     
    
    
     DETAILED DESCRIPTION 
     Specific embodiments of the present invention are now described with reference to the figures, wherein like reference numbers indicate identical or functionally similar elements. Unless otherwise indicated, the terms “distal” and “proximal” are used in the following description with respect to a position or direction relative to the treating clinician. “Distal” and “distally” are positions distant from or in a direction away from the clinician, and “proximal” and “proximally” are positions near or in a direction toward the clinician. In addition, the term “self-expanding” is used in the following description with reference to one or more stent structures of the prostheses hereof and is intended to convey that the structures are shaped or formed from a material that can be provided with a mechanical memory to return the structure from a compressed or constricted delivery configuration to an expanded deployed configuration. Non-exhaustive exemplary self-expanding materials include stainless steel, a pseudo-elastic metal such as a nickel titanium alloy or nitinol, various polymers, or a so-called super alloy, which may have a base metal of nickel, cobalt, chromium, or other metal. Mechanical memory may be imparted to a wire or stent structure by thermal treatment to achieve a spring temper in stainless steel, for example, or to set a shape memory in a susceptible metal alloy, such as nitinol. Various polymers that can be made to have shape memory characteristics may also be suitable for use in embodiments hereof to include polymers such as polynorborene, trans-polyisoprene, styrene-butadiene, and polyurethane. As well poly L-D lactic copolymer, oligo caprylactone copolymer and poly cyclo-octine can be used separately or in conjunction with other shape memory polymers. 
     The following detailed description is merely exemplary in nature and is not intended to limit the invention or the application and uses of the invention. Although the description of the invention is in the context of loading a heart valve prosthesis onto a catheter assembly, the devices and methods described herein can also be used for loading other devices onto catheter assemblies. Furthermore, there is no intention to be bound by any expressed or implied theory presented in the preceding technical field, background, brief summary or the following detailed description. 
       FIG. 1  is a diagram illustrating an example of a catheter assembly  2  for delivering a transcatheter heart valve prosthesis  14  to an implantation site. In the illustrated example, catheter assembly  2  includes a shaft assembly  10  and a sheath assembly  6 . The shaft assembly  10  includes a handle  12 , a carrier shaft  19 , a connector shaft  15 , a distal tip assembly  3 , a distal coupling structure  13 , and a sleeve  11 . The connector shaft  15  interconnects the carrier shaft  19  and the distal tip assembly  3 , and in some constructions has a reduced-sized diameter to permit placement of a prosthetic heart valve  14  over the connector shaft  15 . The distal tip assembly  3  is disposed at the distal end of the shaft assembly  10 . Though not shown in  FIG. 1 , a guide wire lumen can be formed through shafts  15  and  19 . 
     Carrier shaft  19  is sized to be slidably received within the sheath assembly  6 , and is configured in the illustrated exampled for releasable coupling with the heart valve prosthesis  14 . The carrier shaft  19  forms or includes a coupling device  17 . The coupling device  17  is configured to selectively retain a proximal portion of the heart valve prosthesis  14 . The coupling device  17  is configured to releasably mount the heart valve prosthesis  14  to the shaft assembly  10  when the heart valve prosthesis  14  is forced to a collapsed state within the sheath assembly  6 . The sheath assembly  6  is configured to permit deployment of the heart valve prosthesis  14  from the loaded state shown in  FIG. 1 . The catheter assembly  2  is configured to transition from the loaded state in which the sheath assembly  6  encompasses the heart valve prosthesis  14  to a deployed state in which the sheath assembly  6  is withdrawn from the heart valve prosthesis  14 . 
     The catheter assembly  2  shown in  FIG. 1  is merely an example of delivery system that can be used to deliver a heart valve prosthesis transluminally to a desired treatment site. Further description of catheter assembly  2  can be found in U.S. Patent Application Publication No. 2011/0264198, the entirety of which is incorporated by reference herein. As shown, catheter assembly  2  includes coupling device  17  which selectively retains a proximal portion of heart valve prosthesis  14 . As shown in  FIG. 1 , coupling device  17  includes two connections on opposite sides of carrier shaft. A user loading heart valve prosthesis  14  onto catheter assembly  2  must ensure that coupling device  17  and heart valve prosthesis  14  are properly connected at both connection points. Similarly, in a catheter assembly  2  such as shown in  FIG. 1 , the user must ensure that distal coupling structure  13  and heart valve prosthesis  14  are properly connected when loading prosthetic heart valve  14  onto catheter assembly  2 . 
     As discussed above, loading of heart valve prosthesis  14  onto catheter assembly  2  is generally performed in a liquid solution disposed in a reservoir of a loading tray.  FIG. 2  shows an embodiment of a loading tray  22  including a visualization device  100 . Other embodiments of the loading tray and visualization device are possible. Modifications can be made to the embodiments described herein without departing from the spirit and scope of the present invention. Therefore, the following detailed description is not meant to be limiting. Further, the systems and methods described below can be implemented in many different embodiments of hardware. Any actual hardware described is not meant to be limiting. The operation and behavior of the systems and methods presented are described with the understanding that modifications and variations of the embodiments are possible given the level of detail presented. 
     In the embodiment shown in  FIG. 2 , loading tray  22  is configured to be used with a catheter assembly  2  that may be similar to the catheter assembly  2  shown in  FIG. 1 . As described above, catheter assembly  2  generally includes a handle  12  located at a proximal end of catheter assembly  2 , a distal tip assembly  3 , and a sheath assembly  6  between distal tip assembly  3  and handle assembly  12 . It is understood that catheter assembly  2  is merely an exemplary embodiment of a catheter assembly that can be used in conjunction with the devices described herein. Similarly, loading tray  22 , described in detail below, is merely an exemplary embodiment of a loading tray that can be used in conjunction with the visualization device described herein. The present invention is not limited to visualization devices that can be used with loading trays and catheter assemblies as the one described herein. The visualization devices described herein can be used with loading trays having different configurations of reservoirs and receptacles, and with catheter assemblies having different types of handle assemblies, sheath assemblies, and distal tip assemblies. 
     Loading tray  22  will be described briefly herein in conjunction with the visualization devices described herein. Loading tray  22 , however, can be any conventional loading tray adapted to include the visualization devices described herein. For example, and not by way of limitation, loading tray  22  can be the loading tray described in U.S. Patent Application Publication No. 2012/0103840, which is incorporated in its entirety by reference herein. Briefly, loading tray  22  is made of a tray body  23  defining a handle assembly receptacle  24  for seating handle assembly  12  of catheter assembly  2 , an elongate delivery shaft receptacle  28  for seating sheath assembly  6  of catheter assembly  2 , and a reservoir  34  for holding a fluid (not shown in  FIG. 2 ). Tray body  23  can be made of various polymer or composite materials including, for example, Polyethylene Terephthalate Glycol (PETG). Tray body  23  can be molded and have a thickness of approximately 1.0-1.4 mm. The present invention, however, is not limited to polymer materials and can include other suitable materials, for example, stainless steel. A top surface  46  of tray body  23  generally defines the uppermost horizontal plane of loading tray  22 . 
     Reservoir  34  has a bottom surface  44  that is below a portion of delivery shaft receptacle  28  that is contiguous with reservoir  34 . When reservoir  34  is filled with a fluid and handle assembly  12  is seated in the handle assembly receptacle  24 , distal tip assembly  3  is submerged in the fluid in reservoir  34 . 
     In the present embodiment, reservoir  34  is defined by a right wall  36 , a back wall  38 , a left wall  40 , and a front wall  42  that extend downward from top surface  46  to horizontal bottom surface  44  to form a rectangular recess. The depth of the reservoir  34  may vary depending upon the depth necessary to load a medical device on distal tip assembly  3  while submerged in the fluid in reservoir  34 . For example, when loading tray  22  is used to load a heart valve prosthesis on catheter assembly  2 , the depth of reservoir  34  can be approximately 62-68 mm. Although reservoir  34  is rectangular in the illustrated embodiment, the present invention includes a tray that defines reservoirs having other shapes, for example, hemispheres, squares, and cylinders. 
     In an embodiment, loading tray  22  may also include a cover  74 , as shown in  FIG. 2 . Further, a crimping device  78  can be stored in loading tray  22  for delivery. Similarly, the loading tray may be modified to accommodate any of the visualization devices described in the embodiments below such that the visualization devices may be shipped with the loading tray, crimping device, catheter, medical device, and/or other devices associated with the procedure for which catheter is intended. Other features of loading tray  22  shown in  FIG. 2  are not described herein, but are explained in U.S. Patent Application Publication No. 2012/0103840, which is incorporated in its entirety by reference herein. 
     In the embodiment shown in  FIG. 2 , a visualization device  100  is disposed within reservoir  34  of loading tray  22 . Visualization device  100  allows for easier visualization of the portion of catheter assembly  2  facing bottom surface  44  of reservoir  34 . In the embodiment of  FIGS. 2 and 3 , visualization device  100  is not attached to loading tray  22  such that visualization device  100  can slide within reservoir  34  to allow the user to visualize different parts of catheter assembly  2  and heart valve prosthesis  14  while loading heart valve prosthesis  14  onto catheter assembly  2 . However, visualization device in other embodiments could be attached or otherwise coupled to loading tray  22 , as described in more detail below. 
       FIG. 3  shows a perspective view of an embodiment of visualization device  100 . Visualization device  100  includes a frame  102  with a right wall  104 , a left wall  106 , and a floor or bottom surface  108 . Right and left walls  104 ,  106  are attached to and extend generally perpendicularly away from floor  108 . Frame  102  also includes a front support runner  110  and a back support runner  112  spanning a portion of an open top  118  of frame  102 . Frame  102  includes an open front  114  and an open back  116 . The terms “left”, “right”, “front”, “back”, “top”, and “bottom” as used with respect to visualization device  100  do not limit visualization device  100  to any particular orientation. Instead, the terms as used with respect to visualization device  100  are intended to be consistent with the manner in which the terms are used to describe the walls of reservoir  34  of loading tray  22 . Further, when referring to the “open top”, “open front”, and “open back” of the frame, those skilled in the art would recognize that these refer to planes between the walls that allow for a user to access the area. Further, these areas need only be generally open in that there can be some support at the edges of the open plane provided that the user can access the catheter assembly through the open front and open back of the frame. 
     Accordingly, when visualization device  100  is placed into reservoir  34  of loading tray  22 , as shown in  FIG. 2 , right wall  104  of frame  102  is disposed adjacent or against right wall  36  of reservoir  34 , left wall  106  of frame  102  is disposed adjacent or against left wall  40  of reservoir  34 , and floor  108  of frame  102  is disposed adjacent or against bottom surface  44  of reservoir  34 . Similarly, open top  118  is oriented in the direction of top  46  of loading tray  22 , open front  114  is oriented in the direction of front wall  42  of reservoir  34 , and open back  116  is oriented in the direction of back wall  38  of reservoir. Also, front support runner  110  spanning a portion of open top  118  is disposed near the intersection of open front  114  and open top  118  and back support runner  112  spanning a portion of open top  118  is disposed near the intersection of open back  116  and open top  118 . Front and back support runners  110 ,  112  are coupled to or rest on top edges of right wall  104  and left wall  106 , and span the distance between right and left walls  104 ,  106 . The walls of frame  102  may be formed from a clear plastic material, such as an acrylic material. However, any material may be used that is suitable for the purpose of frame  102 , as described in more detail below. 
     A mirror  120  is coupled to floor  108  of frame  102 . Mirror  120  can be a conventional mirror or can be a mirror with magnification. As used herein, the term “mirror” means a reflecting surface such as, but not limited to, a polished metal or glass with a silvery, metallic, or amalgam backing. In one non-limiting example, mirror  120  has two-times magnification. Mirror  120  may be coupled to floor  108  by any means known to those skilled in the art. For example, and not by way of limitation, mirror  120  may be coupled to bottom surface  108  using an adhesive. In another example, mirror  120  may simply abut floor  108  such that the weight of mirror  120  keeps mirror  120  abutting against floor  108  when visualization device  100  is disposed in reservoir  34 . Further, a magnifying glass  122  may rest against front and back support runners  110 ,  112  of open top  118  of frame  102 . Alternatively, front and back runners  110 ,  112  may be excluded and magnifying glass  122  may rest against top edges of left and right walls  104 ,  106 . Magnifying glass  122  may be coupled to front and back support runners  110 ,  112 , such as by an adhesive, but such coupling is not necessary. Magnifying glass  122  may magnify at any desirable, for example, but not limited to, two times magnification. 
     In a method of using visualization device  100  with loading tray  22 , visualization device  100  is placed in reservoir  34  such that right and left walls  104 ,  106  of visualization device  100  abut right and left walls  36 ,  40  of reservoir  34  and floor  108  of visualization device abuts bottom surface  44  of reservoir  34 . The catheter assembly  2  is placed in tray  22  such that tip assembly  3  is placed in a liquid solution which fills at least a portion of reservoir  34 . Catheter assembly is extended through open front  114  and open back  116  of frame  102  such that the tip assembly  3  is located between open top  118  and floor  108  of frame  102 . Magnifying glass  122  may or may not be disposed on front and back support runners  110 ,  112  of frame  102  such that the user looks through magnifying glass  122  to see tip assembly  3  of catheter assembly  2 . The user can look at mirror  120  on floor  108  of frame  102  to see a reflection of the portion of tip assembly  3  facing away from open top  118  of frame  102  (i.e., portion facing mirror  120 ). Accordingly, when loading heart valve prosthesis  14  onto catheter assembly  2 , generally near tip assembly  3 , the user can directly see the portion of the catheter assembly facing top  118  and see a reflection of the portion of the catheter assembly  2  facing mirror  120  in mirror  120 . This permits the user to see any connections on the portion of the catheter assembly  2  facing mirror  120  without having to twist catheter assembly  2  or lift catheter assembly  2  out of the liquid solution in reservoir  34 . This also permits the user to observe the portion of catheter assembly facing mirror  120  to ensure that the heart valve prosthesis  14  is properly loaded onto catheter assembly  2 . 
       FIGS. 4-5  show another embodiment of a loading tray  22  with a visualization device at least partially incorporated into the loading tray  22 . Loading tray  22  will not be described in detail as the features therein are the same as in  FIG. 2  except where specifically described herein with respect to  FIGS. 4-5 . In particular, instead of a separate frame as described in  FIGS. 2-3 , a mirror  220  is incorporated into bottom surface  44  of tray  22 . Mirror  220  may be a separate piece coupled to bottom surface  44 , or can be formed integral with bottom surface  44 . For example, and not by way of limitation, mirror  220  may be adhesively attached to bottom surface  44  such that mirror  220  faces the open top of reservoir  34 . Mirror  220  may be coupled to bottom surface  44  of reservoir  34  in other ways such that a user utilizing tray  22  can see a reflection in the mirror  220  showing an underside of a catheter disposed within reservoir. For example, and not by way of limitation, mirror  220  may be snap fit into clips or other mechanism on bottom surface  44 , or press fit onto bottom surface  44 . In another non-limiting example, at least a portion of bottom surface  44  of reservoir  34  may be transparent and mirror  220  may be coupled to an underside of bottom surface  44 , such as by adhesive, a snap fit or a press fit arrangement. In another non-limiting example, bottom surface  44  of reservoir  34  may be made of a reflecting material or a reflecting material may be added to bottom surface  44 . For example, and not by way of limitation, aluminum oxide may be vapor deposited onto bottom surface  44  to make bottom surface reflective. As shown, mirror  220  covers substantially all of bottom surface  44  of reservoir  34 . However, mirror  220  can be any suitable size such that mirror  220  can be used to observe a side of the catheter assembly facing mirror  220  when a portion of the catheter assembly is disposed in the reservoir. Mirror  220  may or may not include magnification. For example, and not by way of limitation, mirror  220  may have two times magnification to make it easier for the user to see the desired portions of the catheter assembly and heart valve prosthesis. 
     Further, a magnifying glass  222  can be used in conjunction with mirror  220 . Magnifying glass  222  may rest on top surface  46  of tray at left and right walls  36 ,  40  of reservoir  34 . Magnifying glass  222  may be coupled to top surface  46 , such as by an adhesive, or may be provided separate from tray  22  such that magnifying glass  222  can be moved to the desired area by the user. Magnifying glass  222  may have any magnification desirable for use in assisting a user load a prosthetic heart valve onto a catheter assembly. For example, and not by way of limitation, magnifying glass  222  may have two times magnification. 
       FIG. 6  shows an illustration of heart valve prosthesis  14  being loaded onto a catheter assembly  2  as seen using a visualization device as described herein. In  FIG. 6 , the reference numerals ending in “a” are as reflected in mirror  120 ,  220 . In particular a crimper  78  is used to load heart valve prostheses  14  onto catheter assembly  2  within sheath assembly  6 . Coupling device  17  couples shaft  19  to heart valve prosthesis  14 . As can be seen in  FIG. 6 , a user must observe that the coupling device  17  is connected to heart valve prosthesis  14  along a direct line of vision of the user and in the reflection at  17   a . As the heart valve prosthesis  14  continues to be loaded onto catheter assembly  2 , the user can observe that the heart valve prosthesis is smoothly crimped within sheath  6  on both a direct line of vision and as reflected in mirror  120 ,  220 . 
     While various embodiments according to the present invention have been described above, it should be understood that they have been presented by way of illustration and example only, and not limitation. It will be apparent to persons skilled in the relevant art that various changes in form and detail can be made therein without departing from the spirit and scope of the invention. It will also be understood that each feature of each embodiment discussed herein, and of each reference cited herein, can be used in combination with the features of any other embodiment. All patents and publications discussed herein are incorporated by reference herein in their entirety.