Abstract:
Packaging units for use with elongate medical devices such as catheters. An example packaging unit includes a mounting card into which a number of tabs are cut at predetermined angles and shapes. At least some of the tabs are provided in large tab/small tab pairs. The angle and size combination provides for securing the elongate medical device to the card, while reducing trauma experienced by the device during removal from the card. Also, a double tab system is provided in the packaging unit for receiving a hub and strain relief to hold those parts securely. The card may be scored along at least a first side such that, prior to placing a sterile barrier, such as a plastic wrapping or envelope, around the mounting card to sterilely seal a device therein, the card may be bent along the scoring line to lift the sterile barrier off of a surface of the mounting card. The step of bending a portion of the card along the storing line make removal of a device from the mounting card easier and renders the mounting card more rigid and less likely to bend and cause damage to an elongate medical device stored thereon.

Description:
TECHNICAL FIELD 
     The present invention generally relates to the field of medical device packaging, and more specifically to the field of packaging catheters and other similar medical devices. 
     BACKGROUND 
     Numerous medical procedures require the advancement and positioning of elongate medical devices within body lumens. Intravascular catheters, in particular, are currently utilized in a wide variety of minimally invasive medical procedures. Such catheters often have an outer diameter in the range of two or less millimeters near their distal ends. The distal ends are often also highly flexible and may include softened distal tips. Further, some devices (coronary guide catheters, for example) include a formed distal end having a predefined curve adapted to interact in a desired manner with patient anatomy. Packaging these catheters for delivery and/or storage entails a number of concerns. 
     One packaging technique for catheters includes the use of a mounting card. Mounting cards are generally long, somewhat narrow (100+cm by 10-20 cm) cards having a plurality of die-cut tabs that hold the catheter in place. These die-cut tabs are usually created using a manual press that cuts the specific shape of the tab into the mounting card. Once the tabs are cut, the tabs are then raised, allowing the catheter to be woven under the tabs. The tabs are then released and deflect back toward the mounting card, such that the catheter to be held in place by the tabs&#39; downward pressure. One in the art generally knows this weaving procedure as “webbing.” 
     Once mounted on the card, the catheter and mounting card are then wrapped in a sterile barrier, sometimes known as an envelope, and then sealed. The sterile barrier may also be secured down to the card at chosen locations. 
     Physicians have found that catheters fastened by tabs sometimes succumb to physical deformation during the catheter&#39;s removal. With the sterile barrier placed over and around the catheter and mounting card, the catheter is typically removed by simple pulling the catheter through the tabs. Because the distal end is generally the most flexible region of the catheter, the distal end may be deformed and/or kinked quite readily. Pulling the device through a tab may easily impart a new structural formation to the catheter that was not desired by the manufacturer. A further difficulty can arise because the sterile barrier touches the catheter itself, creating additional friction during catheter removal. Extra force is then required to remove the catheter, again subjecting portions of the catheter shaft to stresses that may lead to deformation and/or kinking. 
     Also, because the sterile barrier is often provided such that it holds the catheter against the catheter holding card, the canting (out of plane curvature) provided in certain catheter types can become distorted or damaged either during removal, or during storage and shipping. For example, certain guiding catheters for accessing the aortic arch include curvatures at their distal ends which do not lie in a single plane. Thus, when placed on a generally flat catheter holding card and pressed down on the card, these catheters may lose their desired shape and become less suitable for their intended purpose. Each of these are examples of damage that can result with known catheter packaging systems. There is an ongoing need to provide alternative designs and methods of making and using packaging for medical devices. 
     SUMMARY 
     The invention relates to alternative designs and methods of making and using packaging for medical devices. One example embodiment relates to a catheter packaging unit which includes a mounting card into which a number of tabs are cut at predetermined angles and shapes. At least some of the tabs are provided in large tab/small tab pairs. The angle and size combination provides for securing the catheter to the mounting card, while reducing the trauma experienced by the catheter during removal from the mounting card. Some example embodiments relate to a mounting card that may be scored along at least a first side such that, prior to placing a sterile barrier (for example, a plastic wrapping) around the package to seal a catheter therein, the mounting card may be bent along the scoring line to lift the sterile barrier off of a surface of the card, preventing damage to a catheter stored therein. In yet a further embodiment, a double tab system is provided in the catheter packaging unit for receiving a catheter manifold and hold that portion of a catheter securely. 
     The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present invention. The Figures, and Detailed Description which follow more particularly exemplify these embodiments. 
    
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
       The invention may be more completely understood in consideration of the following detailed description of various embodiments of the invention in connection with the accompanying drawings, in which: 
         FIG. 1  shows an elevation view of an illustrative example catheter mounting card; 
         FIG. 2A  shows a detail view of an example manifold holding tab configuration; 
         FIG. 2B  shows a detail view of an example relatively large tab from  FIG. 1 ; 
         FIG. 2C  shows a detail view of an example relatively small tab from  FIG. 1 ; 
         FIG. 3  shows an elevation view of another illustrative example catheter mounting card adapted for receiving and holding catheters of various sizes having curved distal ends; 
         FIG. 4A  shows a detail view of an example hub holding tab configuration; 
         FIG. 4B  shows a detail view of an example relatively large tab from  FIG. 3 ; 
         FIG. 4C  shows a detail view of an example relatively small tab from  FIG. 3 ; 
         FIG. 4D  shows a detail view of an example secondary tab from  FIG. 3 ; 
         FIG. 5  is a perspective detail view of an illustrative example catheter hub holder; 
         FIG. 6  is a detail view of an example pairing of a large tab and a small tab; 
         FIG. 7  is an elevation view of an example catheter package holding a catheter and including a sterile barrier thereon; 
         FIG. 8  is a detail view of the example catheter hub holder of  FIG. 7 ; and 
         FIG. 9  is a cross sectional view showing the sterile barrier spacer characteristics from  FIG. 7 . 
     
    
    
     While the invention is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention. 
     DETAILED DESCRIPTION 
     The following detailed description should be read with reference to the drawings. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention. 
     For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification. 
     All numeric values are herein assumed to be modified by the term “about,” whether or not explicitly indicated. The term “about” generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many instances, the term “about” may include numbers that are rounded to the nearest significant figure. 
     The recitation of numerical ranges by endpoints includes all numbers within that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). 
     As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise. 
     Several of the embodiments illustrated herein are the result of an arduous testing process. It was noted that with some existing catheter packaging units, a variety of deformations and even kinking of catheter shafts were occurring during shipping of packaged units and removal of catheters from such units. In order to identify structures that were better and/or worse with respect to these problems, a number of tests were performed. 
     One such test made use of a high speed camera to observe the “whipping” of the distal end of a catheter as it was removed from packaging. In some systems using tabs or other structures to hold a catheter to a mounting card, as the catheter is removed the highly flexible distal end of the catheter will be bent and/or stressed during such removal. Several catheters, for example guide catheters, have specially curved distal ends. As the catheter distal end moves past a tab or other structure, its predefined curve may be straightened or otherwise stressed out of shape. When the distal end clears the tab, it will flex back towards its original shape. This movement can be referred to as “whipping”. If there is a large amount of whip, it indicates a greater stress on the catheter shaft. One goal in the design of the following illustrative embodiments was to reduce such whipping. 
     By observing catheter removals with the high speed camera, comparisons were made among several selected designs. It was found that certain tab combinations performed quite well. A particularly successful configuration was that of a combination of large and small tabs. 
       FIG. 1  shows an elevation view of an illustrative catheter mounting card. The catheter mounting card  10  may be formed primarily with a generally planar piece of relatively stiff material shown as a planar piece  12 . The planar piece  12  may be formed, for example, of a paperboard product such as a solid unbleached sulfate, a clay coated new back, solid bleached sulfate, solid fiber, or any other suitable material. 
     The planar piece  12  may have any desired thickness, for example, in the range of about 8 pt to 30 pt thickness. In some embodiments the planar piece  12  may or may not include at least one glossy side, and may be used with or without the glossy side up. The planar piece  12  may have a length chosen for suitability for use with a catheter of a certain size. For example, with a generally straight catheter having a length of one hundred ten to one hundred twenty five centimeters, the planar piece  12  may have an overall length in the range of about one hundred forty centimeters. Further, the width of the planar piece  12  may have a width chosen for suitability and compactness; for example, the width may be in the range of about five to twenty centimeters. For most cases it is sufficient to have a width of about eleven centimeters. The ranges given above, of course, will be understood by one of skill in the art as merely illustrative, and thickness, length, and width of the planar piece  12  may vary as desired. In particular, for shorter catheters (for example down to fifty cm or less), the planar piece  12  may much shorter. 
     A number of structures are defined in the planar piece  12  including hub securing tabs  14 , a number of large tabs  16  and small tabs  18 , and a pair of scored lines  20 . The “large” and “small” tabs  16 ,  18  are described in such terms as being sized relative to one another, and this use of terminology should not be taken as implying a particular range. The large tabs  16  and small tabs  18  are arranged along a line for receiving a catheter on the planar piece  12 . 
     Along the length of the planar piece  12 , two scored lines  20  are included, being cut into the surface of the planar piece  12  near its long edges  22 . The scored lines  20  make it easy to fold up the edges  22  of the planar piece  12 . It can be seen that the planar piece  12  may be shaped so that the scored lines  20  do not extend to either extreme end of the catheter mounting card  10 . When the edges are folded up, as shown below in  FIG. 9 , a sterile barrier can be suspended over the planar piece  12  as well as the hub securing tabs  14  and the large/small tabs  16 ,  18  so that the sterile barrier does not compress a catheter packaged with the catheter mounting card  10 . Further, by folding up the edges, the planar piece  12  may be given added rigidity, preventing kinking of the catheter due to bending of the planar piece  12  during handling, shipping, or storage. As an alternative to folding up the edges, one may also place one or more corrugations extending axially on the planar piece away form the edges thereof. 
     Each of the pieces in FIGS.  1  and  2 A- 2 C may be cut into the planar piece  12  by any suitable method, for example, by die cutting. The individual tabs may be formed by cutting entirely through the planar piece  12  along the lines which fold out and away form the planar piece  12 . The folding line allowing the tabs (lines  40  shown in each of  FIGS. 2A-2C ) to be folded out of the planar piece  12  may be scored on either or both sides of the planar piece  12 , as desired. 
     As explained above, a number of tests were performed using different tab sizes, placements, size combinations, and so forth. During this testing it was found that certain size combinations and angles performed better than others. Details of some of the better combinations, shapes and angles are further explained below with reference to  FIGS. 2A-2C . 
     The design for the hub securing tabs  14  is further explained with reference to  FIG. 2A , which shows a detail view of a hub holding tab configuration, as well as  FIG. 8 , below. As shown in  FIG. 2A , the hub securing tabs  14  include a first tab  30  having a semicircular cutout  32  for receiving a cylindrical portion of a catheter hub. An embodiment is further illustrated in  FIG. 8 , where the sizes and spacing for the first and second hub securing tabs  30 ,  34  are further explained. It should be noted that for the purposes herein, the word “hub” can be inclusive of a variety of manifolds and hubs including but not limited to a single port hub as shown in  FIG. 8 , but also Y-shaped manifolds and hubs, multiport hubs, and the like. The hub securing tabs  14  also include a second tab  34  having a circular cut-out  36  and a notch  38 . The notch  38  and circular cut-out  36  are adapted for receiving a more distal portion of the hub. For example, the hub may include a ribbed, spiral, or finned strain relief for an attached catheter shaft. The first tab  30  and second tab  34  are spaced from one another sufficiently to allow easy placement of a portion of catheter hub/manifold therebetween. For example, an illustrative embodiment has the first tab  30  about two and a half centimeters from the second tab  34 , as further explained below with reference to  FIG. 5 . This distance may vary, of course, depending on the particular catheter hub and strain relief to be held. 
     While the securing tabs  14  shown in  FIG. 2A  are adapted for use with a generally cylindrical catheter hub/manifold, this is not necessary, as the tabs may include openings or spaces for receiving polygonal, semicircular, oval, or other shapes as well. Further, while the example embodiment of  FIG. 2A  illustrates a notch  38  adapted for receiving a portion of a strain relief, in other embodiments the notch  38  may be adapted to receive other portions of a hub/manifold/strain relief. 
       FIG. 2B  shows a detail view of a relatively large tab from  FIG. 1 . The large tab  16  includes a leading corner  50  and has a generally triangular form such that an angle  52  is formed at the leading corner  50 . The corner  54  can form a vertex of the large tab  16  and may be radiused to remove any sharp edges that can damage a catheter or breach a sterile barrier disposed over the large tab  16 . The testing performed showed that very good results could be had with an angle  52  of about thirty-eight degrees, or in a range of about thirty to forty five degrees, or in a range of about thirty-six to forty degrees. Overall, the tab length along the bending line  40  may vary as desired, particularly depending upon the size of the catheter to be held in place. 
       FIG. 2C  shows a detail view of a relatively small tab  18  from  FIG. 1 . The small tab  18  includes a leading corner  60  and also has a generally triangular shape forming an angle  62  at the leading corner  60 . A corner can form a vertex of the small tab  18  and may be radiused as shown at  64  to eliminate any sharp edges that could damage a catheter or breach a sterile barrier used in packaging a catheter. The testing noted above found that improved results could be had with an angle  62  of about forty-five degrees, as well as in ranges of about forty to fifty degrees or forty-three to forty-seven degrees. Again, the tab length along the bending line  40  may vary as desired, to some extent depending upon the size (French) of the catheter to be held in place. The example ranges that are referred to herein are examples of those wherein “whipping” of a catheter being removed past the large tabs  16  and small tabs  18  was reduced in comparison with other tab sizes and combinations. 
     In an illustrative working embodiment, the large tab  16  has a length along the fold line  40  of about 2.6 centimeters, while the small tab  18  has a length along the fold line  40  of about 1.5 centimeters, with a tolerance in manufacturing of about 1.5 millimeters for either. This illustrative embodiment used an angle  52  for the large tab  16  of about thirty-eight degrees, and an angle  62  for the small tab  18  of about forty-five degrees, and illustrated very good performance in the above described “whip” testing. 
     The relative sizes for the large tabs  16  and small tabs  18  may also add to the effectiveness of the overall device; as noted, a ratio of about 1.75 to 1.0 (large tab  16  to small tab  18 ) is included in the illustrative embodiment. Ratios in the range of about 1.5 to 2.0 to 1.0 are considered advantageous. Furthermore, in some embodiments, the relationship between the angles used may be significant to achieve the results noted above, with a combination small tab/large tab wherein the small tab has a larger angle than the large tab being a positive design feature in at least some embodiments. 
       FIG. 3  shows an elevation view of another illustrative catheter mounting card adapted for receiving and holding catheters of various sizes having curved distal ends. The catheter mounting board  110  includes a generally planar piece  112 , on which are formed a hub securing tabs  114 , large tabs  116 , small tabs  118 , scoring lines  120  defining edge portions  122 , and a number of curve tabs  124 . The overall length of the mounting card  110  may vary widely depending on the size of catheter for which it is designed. One illustrative example has a length of about one-hundred and ten centimeters, with the edge portions  122  ending about 5.5 centimeters from the end opposite the hub securing  114 . 
       FIG. 4A  shows a detail view of a hub holding tab configuration. The hub holding tabs  114  again include a first tab  130  having a circular cut-out  132  and a second tab  134  having a circular cut-out  136  and a notch  138 . Each tab  130 ,  134  maybe folded upward and away form the planar piece along a folding line  140  which may, again, be scored if desired to render the folding easier and more readily defined along a straight line. The configuration is generally similar to that of  FIG. 2A . Again, while a circular design is illustrated, it should be apparent to one of skill in the art that non-circular formations may also be used to match the design of a catheter hub, manifold, or strain relief. 
     It should be noted that scoring the folding lines for the tabs will make the folding line more flexible, reducing the force on the catheter. While this makes it easier to remove a catheter without stressing it significantly, the reduced force also means that the catheter is not held in place as strongly. This tradeoff should be considered in selecting whether to include such scoring or not. 
       FIG. 4B  shows a detail view of a relatively large tab from  FIG. 3 . The large tab  116  includes a leading corner  150  defining an angle  152 , as well as a second corner  154  and a folding line  140 . The second corner  154  can form a vertex of the tab  116  and can have a radius as shown in  FIG. 4B .  FIG. 4C  illustrates the small tab  118  having a leading corner  160 , angle  162 , a second corner  164 , and a folding line  140 . The second corner  164  can form a vertex of the tab  118  and can have a radius as shown in  FIG. 4C . The large tab  116  and small tab  118  may be generally the same as the tabs shown and explained above with reference to  FIGS. 2B-2C . Their orientation may be similar, too. 
       FIG. 4D  shows a detail view of a curve tab from  FIG. 3 . The curve tab  124  is disposed on the catheter holding card to provide support and to secure a curved distal portion of a catheter to the card. The curve tab  124  includes a folding line  140 , opposite of which is a radiused angle  142  defining an angle  144 . The angle may vary widely, but in some embodiments can be in the range of thirty to fifty degrees. Disposition of the curve tab  124  (location and angle) will depend upon the shape of a particular catheter for which the catheter holding card is designed. The length, from the folding line  140  to the radiused angle  142 , may vary as well depending on the location of the curve tab as well as the catheter for which it is used. In an illustrative embodiment, the lengths of tabs on the same catheter holding card may vary from less than a centimeter up to about three centimeters, or more. Further, while the curve tab  124  is shown as an isosceles triangle with a radiused peak, the curve tab may have rectangular, polygonal, or other triangular shapes as well. The locations for curve tabs such as tab  124  may vary depending upon the configuration/shape of the distal curvature of a catheter intended to be packaged on the particular mounting card, as one of skill in the art would understand. In particular, the curve tab  124  would be placed such that it could hold a catheter in position without altering the shape of its distal curvature. 
       FIG. 5  is a perspective detail view of an illustrative catheter hub holder. Again, while a circular configuration is shown, other shapes may be used as desired, including oval, polygonal, and combinations of curved/flat edges. The catheter hub holder  200  is shown as being cut out of a generally planar material  202  that is part of a catheter package. As illustrated, the holder  200  includes a first tab  204  and a second tab  206 , which are folded up and away from the planar material  202  along fold lines  208 . The fold lines  208  may be scored to make folding them along a straight line easier. 
     The first tab  204  includes a circular cutout  210 . The circular cutout  210  may include an opening at its upper end allowing passage of a cylindrical portion of a catheter therein. In use, a catheter will typically be passed into the circular cutout  210  through the opening at a location where the catheter has a lesser diameter, and then moved such that a cylindrical portion of the catheter is in the circular cutout, preventing passage through the opening in the circular cutout. The following sizes are merely illustrative of one embodiment designed for use with a catheter/hub of a certain size, and (particularly the sizes for the circular cutouts  210 ,  212 ) may vary depending upon the size of catheter intended for storage/shipping thereon. 
     In an illustrative embodiment, the fold lines  208  are about 2.5 centimeters apart, each extending for about 2.5 centimeters along the base of the tabs  204 ,  206 . The first tab  204  can be about a centimeter high, with a width near the top of about 1.6 centimeters. The radius of the circular cutout  210  of the first tab  204  can be about 0.33 centimeters. The center of the cutout  210  can be set away from the upper edge of the first tab  204  to create an opening about 0.13 centimeters wide at the upper edge of the first tab  204 . 
     The illustrative second tab  206  has an upper width of about 1.9 centimeters and can be about 0.8 centimeters high. The notch  214  can be formed at a ninety degree angle with an edge set about 2.2 millimeters from the upper edge of the second tab  206 . The radius of the circular cutout  212  of the second tab  206  can be about 1.6 millimeters. 
       FIG. 6  is a detail view of a pairing of a large tab and a small tab. The tab pairing  200  is shown for the purpose of illustrating one example layout for the tabs. On a planar material  222  two tabs are cut and folded out along fold lines  224 . The large tab  226  has a trailing edge  230 , and the small tab  228  has a trailing edge  232  as well. The distance  234  between the trailing edges  230 ,  232  can be about 2.5 centimeters. The distance between the fold lines  224  can be about 1.4 centimeters. The sizes for the illustrative tabs correspond to the sizes noted above with reference to in  FIGS. 2B and 2C . In particular, the large tab  226  has a length of about 2.6 centimeters, such that its leading corner can be almost even with the trailing edge of the smaller tab. The height of the large tab  224  can be approximately equal to the distance between the fold lines. 
       FIG. 7  is an elevation view of a catheter package holding a catheter and including a sterile barrier thereon. The package includes a mounting card  300  with sides  302  that extend upward, more or less “out” of the page on the elevation drawing. A sterile barrier  304  can be disposed thereover; the sterile barrier may be typically provided as a bag or envelope, but may be simply a wrapped piece. A catheter  306  is disposed on the mounting card  300  inside the sterile barrier  304 . The mounting card  300  includes hub holding tabs  308  that hold the hub of the catheter  306 . A number of tab pairs  310  hold the shaft of the catheter, while the curved distal end of the catheter is held in place with additional tabs  312 ,  314 ,  316 . As shown, a portion  318  of the sterile barrier  304  and mounting card  300  extends beyond the end of the sides  302 . This distance where the sides  302  are not included may extend, for example, for about 7.5-10.5 cm. In a working example embodiment, this portion  318  extends for about 8.9 cm. 
     By excluding the sides along this portion  318 , the catheter and mounting card  300  may be inserted into a sterile barrier “envelope” that is already sealed along three sides. In particular, the mounting card  300 , with a catheter secured thereto, can be inserted, hub end first, into the envelope until the hub end of the mounting card  300  cannot be inserted further. The sterile barrier is sized such that, with the mounting card  300  fully inserted, a portion of the sterile barrier extends beyond the sideless portion  318 , as shown at  320  allowing for a seal to be made at that location. The seal may be, for example, a thermal seal, adhesive, mechanical, or any other suitable seal. It should be noted that for the purposes of illustration the sterile barrier  304  is shown as extending by an exaggerated amount beyond the hub end of the mounting card  300  in  FIG. 7 . 
       FIG. 8  is a detail view of the catheter hub holder of  FIG. 7  taken at location  8  in  FIG. 7 . As shown, the mounting card  300  includes a first tab  330  and second tab  332 . The catheter includes a hub/manifold  334  and a strain relief  336 . The first tab  330  secures the hub/manifold  334  at a first, generally cylindrical, location, while the second tab  332  is secured to the strain relief  336 , as explained above with reference to  FIG. 5 . The sterile barrier  304  is shown over, but not necessarily contacting, any of the tabs  330 ,  332 , hub/manifold  334 , or strain relief  336 . 
       FIG. 9  is a cross sectional view showing the sterile barrier spacer characteristics from  FIG. 7 . As shown in  FIG. 9 , the sides  302  of the mounting card  300  hold the sterile barrier  304  away from the planar portion of the mounting card  300  by a space  340 . The space  340 , in an illustrative embodiment, can be about 1.1 centimeters wide. This allows room for a canted catheter to retain its curved distal end while encased in the sterile barrier  304  and secured to the mounting card  300 . Further, the space  340  makes it easier to remove a catheter from the combination of the sterile barrier and mounting card by eliminating friction, particularly toward the distal end of the catheter, caused by a sterile barrier pressing the catheter against the mounting card  300 . 
     Those skilled in the art will recognize that the present invention may be manifested in a variety of forms other than the specific embodiments described and contemplated herein. Accordingly, departures in form and detail may be made without departing from the scope and spirit of the present invention as described in the appended claims.