Patent Publication Number: US-2020276383-A1

Title: Tube management device for an infusion set

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application claims priority to Provisional Application No. 62/557,877, filed Sep. 13, 2017, and Provisional Application No. 62/665,225, filed May 1, 2018, each entitled TUBE MANAGEMENT DEVICE FOR AN INFUSION SET, both of which are hereby incorporated by reference in their entirety. 
    
    
     FIELD OF THE DISCLOSURE 
     The present disclosure relates to infusion sets for a delivering a medication to a patient, and more particularly to a tube management device for an infusion set. 
     BACKGROUND 
     The present disclosure relates to infusion sets for a delivering a medication to a patient. Infusion sets typically include tubing that leads from a medication delivery device, such as a pump, to a cannula that is inserted into the subcutaneous tissue of the patient. Such infusion sets are often used to inject insulin or other suitable medications. 
     A typical infusion set also includes a connector hub disposed between the medication pump and the cannula. Connector hubs include two mating parts that allow the pump to be connected and disconnected from the cannula without having to remove the cannula from the subcutaneous tissue. A conventional connector hub includes a female part having a septum and a male part having a needle that pierces the septum when the male and female parts are joined together. 
     In some infusion sets, the connector hub also functions as an insertion hub with the cannula being located at the same hub as the septum/needle assembly connection. In other infusion sets, the connection hub is separate from the insertion hub. In an infusion set having separate connection and insertion hubs, a length of tubing will extend from the connection hub housing the septum/needle assembly to the insertion hub housing the cannula. In both types of infusion sets, a length of tubing will extend from the pump to the connection hub. 
     In both types of infusion sets, the hubs are typically designed to attach to the skin of the user with an adhesive. Adhesively securing the hub associated with the cannula to the skin of the user helps reduce the movement of the cannula relative to the tissue of the patient and thereby helps prevent inadvertent withdrawal of the cannula. When a separate insertion hub and connection hub are used, the adhesive attachment of the connection hub to the patient can provide strain relief with regard to the tube leading to the insertion hub. Although such infusion set arrangements can be effective, they also have several shortcomings. 
     One drawback when using a system having only a pump and a combined connection and insertion hub is that there is no second hub disposed between the pump and combined connection/insertion hub to provide strain relief on the tubing leading to the hub housing the cannula. 
     For infusion sets having separate connection and insertion hubs, the length of tubing connecting the connection hub to the insertion hub is typically fixed in length. This fixed length of tubing may not be optimal for all patients. For example, it may be desirable to use a shorter length of tubing for small children than for an adult for optimal comfort when placing the hubs on the patient. 
     Another drawback is that once the connection hub has been affixed to the body, it cannot be repositioned. Thus, the location and angle at which the tube leaves the hub and the length of tubing between the connection hub and the insertion hub are also fixed. The angle at which the tubing protrudes from the connection hub toward the pump may limit the ability of the user to wear the pump in different locations on their body. The fixed length of tubing between the connection hub and insertion hub may also present difficulties. For example, a relatively long length of tubing may be uncomfortable or become snagged on clothing while a relatively short length of tubing may pull on the insertion site and cause discomfort. 
     A drawback to using separate connection and insertion hubs is that medication remains in the fixed length of tubing between the two hubs when the pump is detached. The medication in this fixed length of tubing may spend an extended time in this length of tubing where it may be subjected to elevated temperatures such as when the patient takes a bath. Additionally, if there is any back-flow from the patient into the infusion set, the medication within this length of tubing may be contaminated and may degrade. 
     Another drawback is that conventional connection hubs and insertion hubs provide the user with limited choice. For example, infusion sets are typically provided with a fixed length of tubing and the user is limited to a selection of a short tube length (typically between 16 inches (40.6 cm) and 18 inches (45.7 cm)), a medium tube length (typically between 23 inches (58.4 cm) and 24 inches (61.0 cm)), long tube length (typically between 31 inches (78.7 cm) and 32 inches (81.3 cm)) and extra long tube length (typically between 42 inches (106.7 cm) and 43 inches (109.2 cm)). Longer lengths are useful for larger individuals and for those patients who want to wear a pump at a convenient location, such as on a waist belt, and infuse at a remote location, such as a forearm. Users are encouraged to rotate infusion sites to prevent scar tissue formation. Thus, a patient may want to use a long length of tubing for one infusion site and a shorter length for the next infusion site. 
     Infusion sets are typically purchased in boxes having multiple sets (e.g., ten infusion sets per box), and multiple, identical boxes are often purchased in a single order to maximize insurance benefits. As a result, a patient is often locked into a particular length of tubing and would find it cost-prohibitive to purchase multiple infusion sets having different length tubing. 
     A way to minimize such drawbacks and enhance patient convenience is desirable. 
     SUMMARY 
     The present disclosure provides a tube management device that allows a user to easily and conveniently manage a length of flexible tubing used to transfer medication. 
     According to an embodiment of the present disclosure, a tube management device is disclosed for an infusion set having a flexible tube for conveying medication between a reservoir and an infusion site on a patient. The device includes a central spindle defining an axis, a base member projecting radially outwardly from the central spindle, an upper member projecting radially outwardly from the central spindle, and a plurality of retainer members disposed on at least one of the base member and the upper member. The base member and the upper member are axially spaced apart. The central spindle, the base member, the upper member, and the plurality of retainer members define a toroidal space sized to receive a variable length of the flexible tube. The plurality of retainer members restrict radially outward movement of a length of the flexible tube wound about the central spindle. 
     According to another embodiment of the present disclosure, a tube management device is disclosed for an infusion set having a flexible tube for conveying medication between a reservoir and an infusion site on a patient. The device includes a support member adapted to be secured to the patient and a reel member rotatably mountable on the support member and adapted to receive the flexible tube. When the reel member is mounted on the support member, a rotation of the reel member in a first direction is operable to wind the flexible tube onto the device and a rotation in a second direction is operable to extend the flexible tube from the device. The reel member is detachable from the support member with a length of flexible tube wound on the reel member. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The above mentioned and other features of the present disclosure, and the manner of attaining them, will become more apparent to those skilled in the art upon consideration of the following detailed description of embodiments taken in conjunction with the accompanying drawings, wherein: 
         FIG. 1  is a schematic view of an infusion set with a tube management device according to an illustrative embodiment. 
         FIG. 2  is a schematic view of another infusion set with a pair of tube management devices according to another embodiment. 
         FIG. 3  is a perspective view of an exemplary embodiment of a tube management device. 
         FIG. 4  is a partially exploded view of the tube management device of  FIG. 3 . 
         FIG. 5  is a perspective view of a device similar to that of  FIG. 3  further including a mounting member releasably securable to the tube management device. 
         FIG. 6  is a top view of a mounting member of  FIG. 5 . 
         FIG. 7  is a partial detail view of the mounting member of  FIG. 6 . 
         FIG. 8  is a bottom view of a device releasably securable to the mounting member of  FIG. 6 . 
         FIG. 9  is a partial detail view of the device of  FIG. 8 . 
         FIG. 10  is an exploded perspective view of another exemplary embodiment of a tube management device. 
         FIG. 11  is a perspective view of the device of  FIG. 10  with a tube engaged with the device. 
         FIG. 12  is a perspective view of the device of  FIG. 11  after winding additional tubing on the device. 
         FIG. 13  is a perspective view of the device of  FIG. 12  with an attached cap, wherein the reel member is disengaged from the support member with tubing secured on the reel member. 
         FIG. 14  is an exploded perspective view of another exemplary embodiment of a tube management device. 
         FIG. 15  is a cross-sectional view of the central spindle of the device of  FIG. 14  taken along line A of  FIG. 14 . 
         FIG. 16  is a cross-sectional view of the base member of the device of  FIG. 14  taken along line B of  FIG. 14 . 
         FIG. 17  is a top perspective view of the assembled spindle and base member of the device of  FIG. 14 . 
         FIG. 18  is a bottom perspective view of the upper member of the device of  FIG. 14 . 
         FIG. 19  is an exploded perspective view of another exemplary embodiment of a tube management device. 
         FIG. 20  is a bottom perspective view of the upper member of the device of  FIG. 19 . 
         FIG. 21  is a perspective view of another exemplary embodiment of a tube management device. 
         FIG. 22  is an exploded perspective view of the device of  FIG. 21 . 
         FIG. 23  is a partially exploded, bottom perspective view of the device of  FIG. 21 . 
     
    
    
     Corresponding reference characters indicate corresponding parts throughout the several views. Although the exemplifications set out herein illustrate embodiments of the invention, in several forms, the embodiments disclosed herein are not intended to be exhaustive or to be construed as limiting the scope of the invention to the precise forms disclosed. 
     DETAILED DESCRIPTION 
       FIG. 1  schematically depicts an infusion set  20  having a cannula  24  to deliver medication from a medication reservoir  22  to a patient  26 . Medication reservoir  22  may take the form of a pump operably coupled with a reservoir whereby the pump discharges the medication, such as insulin for example, which flows through flexible tubing  28  to cannula  24  where it is subcutaneously injected into patient  26 . Infusion set  20  has a combined connection/insertion hub  30  which is attached to the skin of the patient. A tube management device  36  is attachable to patient  26  and engages flexible tubing  28  at a location between reservoir  22  and hub  30  as schematically depicted in  FIG. 1 . In one embodiment, flexible tubing  28  is made of a plastic material. 
     Several embodiments of a tube management device  36  are disclosed herein and discussed in greater detail below. The use of such a tube management device  36  in the fluid path between reservoir  22  and hub  30  allows the user to better control and secure the tubing  28 . Further, device  36  is configured to provide strain relief such that if a force is exerted on tube  28  between reservoir  22  and device  36 , such as by an accidental snagging of tube  28 , the force will be resisted by device  36 , and tube  28  will not exert a force on hub  30  which might otherwise dislodge or disconnect cannula  24 . For infusion sets having a particularly long length of tubing between reservoir  22  and hub  30 , more than one device  36  may be used to control the excess length of the tubing. 
       FIG. 2  schematically depicts an infusion set  21  having a connector hub  32  that is physically separate from an insertion hub  34 . Connector hub  32  is located in the fluid path between medication reservoir  22  and insertion hub  34  which houses cannula  24 . Flexible tubing  28  conveys the medication from reservoir  22  to connection hub  32  and from connection hub  32  to insertion hub  34 . Tube management devices  36  may engage tube  28  at locations between reservoir  22  and connection hub  32  and between connection hub  32  and insertion hub  34  as schematically depicted in  FIG. 2 . 
     It is noted that infusion sets having separate connection and insertion hubs typically have a relatively short length of tubing between the connection hub  32  and insertion hub  34  that may not require a tube management device. For example, such tube lengths may be between 2 inches (5.1 cm) and 3 inches (7.6 cm). Nevertheless, the use of one or more tube management devices as described herein may be used with the tube at any point in the system where a length of tubing would benefit from the inclusion of such a device. 
     In an infusion set such as depicted in  FIG. 2 , tube management devices  36  may be employed both between reservoir  22  and connection hub  32  and between connection hub  32  and insertion hub  34  to meet the needs of the patient. 
     In various embodiments, both types of infusion sets  20 ,  21  of  FIGS. 1 and 2  have certain advantages. For example, infusion set  21  with its separate connection hub  32  separates the functionality of connecting and disconnecting the pump from the insertion hub and thereby reduces the likelihood that the act of connecting or disconnecting the pump at the connection hub will disturb the cannula. More importantly, it also allows the separate connection hub  32  to act as strain relief for the insertion hub  34 . However, the tubing between the insertion hub and connection hub is filled with medication and remains connected to the patient even when the rest of the infusion set is removed. The medication contained within this length of tubing (which may be approximately 15 microliters in some infusion sets) may therefore be exposed to different environmental conditions than the remainder of the medication transported by the set. For example, it may be subjected to higher temperatures when the user takes a bath. Moreover, if there is any back-flow from the patient into the infusion set, the medication contained in this length of tubing between the insertion hub and the connection hub may be contaminated and may degrade. 
     The use of a tube management device  36  between the reservoir  22  and a combined hub  30  ( FIG. 1 ) can provide strain relief for the cannula while eliminating the length of tubing between the insertion hub  34  and connection hub  32  that retains medication when the remainder of the set is disconnected ( FIG. 2 ). 
     By providing a tube management device  36  between the reservoir and combined hub  30 , the tube management device  36  is configured to prevent strain from being imparted to the inserted cannula  24 . Without such a strain relief device in place, strain may be imparted to the cannula  24  when the user pulls on the infusion tubing  28 , which may happen if the user adjusts a waist-belt supporting the pump, snags the tubing on an object, drops the pump, or removes clothing supporting the pump. However, if the tube management device  36  is between the reservoir and combined hub  30  it will absorb such strain and resist dislodgement of the cannula from the patient&#39;s body. 
     The use of a tube management device  36  as described herein eliminates or substantially reduces the need for a separate connection hub to provide strain relief and thereby provides strain relief without creating a length of tubing that can lead to the degradation of the medication as described above. 
     The use of a tube management device  36  also facilitates the use of a relatively long length of tubing between reservoir  22  and either a connection hub  32  or a combined connection/insertion hub  30 . The use of a relatively long tube  28  between the connection hub  32  and reservoir  22 , or, between the insertion hub  30  and reservoir  22 , allows the user greater freedom in choosing the wear location of the reservoir  22  and also greater freedom in selecting the insertion site. The use of such longer tube lengths, however, may present problems when the locations chosen do not require the full length of the tube being used. In such a case, the use of one or more tube management devices  36  is beneficial. 
     Several embodiments of suitable tube management devices are illustrated in  FIGS. 3-23  and are discussed herein. These devices may be engaged with tube  28  and disengaged from tube  28  without disconnecting the terminal end of the tube (i.e., without disconnecting reservoir  22 , and without disconnecting from the hub  30 ,  32  or  34 ), and without having to thread the terminal end of tube  28  through the device. In other words, a non-terminal portion of the flexible tube  28  may be operably engaged with and disengaged from the devices when the flexible tube  28  is operably connected to convey medication between the reservoir and the infusion site. 
     Because the disclosed devices are engageable with a tube that is already operably connected to the infusion set without disconnecting either end of the tube, the devices may be positioned at any point in the system where there is excess tubing that would be benefit from the use of a management device or a need for strain relief. Multiple devices may also be used for different sections of tubing in the system, or, with a single section of particularly long tubing. 
     A first embodiment of such a device is depicted in  FIGS. 3 and 4  which illustrates a tube management device  72 . Tube management device  72  is suited for use in an infusion set having flexible tubing  28  for conveying medication between a reservoir and an infusion site on a patient. Device  72  is shown in an exploded view in  FIG. 4  and includes a base member  74  adapted to be attached to the patient, an upper member  76 , and a central spool or spindle  78  that is positioned between base member  74  and upper member  76 . In the illustrated embodiment, upper member  76  and spindle  78  are integrally formed together and are rotatably mounted on base member  74  by engaging shaft  84  on base member  74  with socket  86  on upper member  76 . An adhesive patch  40  is used to secure base member  74  to the patient. 
     Central spindle  78  defines an axis  88 . Both base member  74  and upper member  76  project radially outwardly from spindle  78  with the base member  74  and upper member  76  being axially spaced apart. A plurality of retainer members  82  are disposed on either the base member  74  or the upper member  76  and project toward the other one of the base member and the upper member whereby the central spindle  78 , the base member  74 , the upper member  76  and the plurality of retainer members  82  define a toroidal space  79 . Alternatively, the base member  74  and the upper member  76  may each include retainer members  82  arranged such that the retainer members  82  are spaced apart (similar to  FIG. 3 ) when device  72  is assembled. Toroidal space  79  acts as a holding chamber within which a variable length of the flexible tube  28  may be wound about the central spindle  78  with the plurality of retainer members  82  restricting radially outward movement of the flexible tubing  28  wound about the central spindle  78 . 
     Thus, a user seeking to manage an excess length of tubing  28  may wind the excess length of tubing  28  about spindle  78  within the toroidal volume  79  surrounding spindle  78  and disposed between base member  74  and upper member  76 . Base member  74  defines a plurality of grooves  80  circumferentially spaced about the outer perimeter of base member  74 . Grooves  80  are illustratively arcuate-shaped channels in base member  74  that grippingly receive tube  28  when tube  28  is positioned in the groove  80 . Tube  28  may be engaged with a groove  80  at the location  27  where it enters device  72  and/or the location  29  where it exits device  72  to thereby secure tube  28  to device  72  and to set the length of tubing  28  disposed in device  72 . Placing a plurality of grooves  80  about the outer perimeter of base member  74  provides flexibility in the location where tube enters and leaves the device. Grooves  80  may also be disposed along the outer perimeter of upper member  76 . 
     It is noted that, while the user may engage tubing  28  with a groove  80  at both the location where tube  28  enters the device and where tube  28  exits the device, the user may alternatively engage tube  28  at only one location. The wrapping of tube  28  about spindle  78  may, in some situations, also be sufficient by itself to provide strain relief without the use of grooves  80 . In an exemplary configuration, a user may employ device  72  to engage tube  28  in a groove  80  at the point nearest the insertion hub and to leave the tube un-engaged with a groove  80  at the point nearest the reservoir  22 . In this example, the point of engagement with a groove  80  nearest the insertion hub provides strain relief for the insertion hub and the loose end facing the reservoir allows excess tubing to be more easily enter or be removed from toroidal cavity  79 , e.g., by wrapping or unwrapping tube  28  on spindle  78 . 
     The illustrated plurality of circumferentially spaced retainer members  82  extending between upper member  76  and base member  74  along the outer radial edge of upper member  76  to thereby define the outer radial limit of toroidal space  79  are formed out of a material having sufficient resilient flexibility that allows members  82  to be bent outwardly and inwardly to allow tube  28  to be moved into or out of toroidal space  79 . 
     More specifically, the illustrated retainer members  82  are resiliently flexible between an at rest position and a flexed position. The flexible retainer members  82  are positionable in the flexed position by the application of a biasing force on the flexible retainer members and the flexible retainer members  82  return to the at rest position when not subject to the biasing force. In  FIG. 3 , dashed outline  83  indicates a flexed position of a retainer member  82  when subjected to a biasing force as exemplified by arrow  81 . It is noted that the biasing force indicated by arrow  81  is a radially outwardly directed force as might occur when removing tube  28  from space  79 . Such a force may also be exerted by a user&#39;s finger when inserting tube  28  into space  79 . Alternatively, the biasing force may push the retainer members  82  inwardly when inserting additional tubing into space  79 . Pushing members  82  inwardly may also be used to remove tubing  28  and, in other embodiments, members  82  may be biased to the side to provide clearance for the entry and exit of tube  28 . 
     Flexible tubing  28  wound about the central spindle  78  is retained within the toroidal space  79  by the plurality of flexible retainer members  82  when the retainer members are in the at rest position. Biasing the flexible retainer members  82  to the flexed position allows passage of the tubing  28  between the distal end of retainer members  82  and the base member  74  and thereby allows the length of the flexible tubing  28  wound about the central spindle  78  within the toroidal space to be increased or reduced. In assembly, the gap distance between the at-rest retainer members  82  and the base member  74  is less than a diameter of the tubing  28  to thereby block tubing  28  from exiting toroidal space  79  without application of the biasing force. In some embodiments, the retainer members  82  abut base member  74  in the at-rest position. 
     Alternatively, members  82  may be rigid members but have a shortened length that allows tube  28  to be slid into space  79  between the distal end of the member  82  and base member  74  without flexing the member  82 . In this embodiment, it may also be advantageous that some (e.g., half) of the retainer members extend from upper member  76  and the remainder from base member  74  with the location of the retainer members  82  alternating to thereby facilitate the retention of tube  28  within space  79  by the retainer members  82 . The use of such retainer members  82  not only facilitates retaining that portion of tube  28  wound about spindle  78  in toroidal space  79 , but also facilitates retaining the angular position of tube  28  at the points where it enters and leaves toroidal space  79 . 
     In the illustrated embodiment, retainer members  82  are all located on upper member  76  and extend toward base member  74 . Alternative embodiments, however, may utilize retainer members that all extend from the base member toward the upper member, or, as mentioned above, have retainer members that extend from both the base member and upper member. Where all of the retainer members extend from only one of the upper member or base member, it may generally be advantageous for arcuate grooves  80  to be located on the opposite member as in the illustrated embodiment wherein all of the retainer members  82  extend from upper member  76  and grooves  80  are located on base member  74 . This positioning of the retainer members  82  and grooves  80  positions the grooves near the unattached distal ends of retainer members  82  where passage of tube  28  will occur between the distal end of retainer members  82  and base member  74  when inserting or removing tube  28  from toroidal space  79  and thereby provide a convenient location for gripping tube  28 . 
     In the illustrated embodiment, upper member  76  is not separable from the device. However, alternative embodiments employ an upper member that is detachable to thereby facilitate the extension or retraction of tube  28 . In still other embodiments, spindle  78  may take the form of a telescoping element that allows upper member  76  to be axially moved relative to base member  74  without detachment of upper member  76  to thereby facilitate the extension or retraction of tube  28 . 
     Flexibility in the length of the tube stored within toroidal space  79  is provided by the ability of the user to select how much of the tube to wrap about spindle  78  and to select which grooves  80  for securing the enter/exit of tube  28  from device  72 . While  FIG. 3  illustrates tube  28  extending less than one full wrap about spindle  78 , the user may wrap tube  28  around spindle  78  several times to thereby manage a greater length of tube  28 . 
     In the illustrative embodiment, upper member  76  and spindle  78  are rotationally fixed relative to base member  74  when coupled to base member  74 . In an alternative embodiment, upper member  76  and spindle  78  may rotate relative to base member  74  as indicated by arrow  75 . By providing a rotatable upper member  76  and spindle  78 , the length of tube  28  disposed about the spindle  78  within the holding chamber may be adjusted by rotation of the upper member and spindle. A locking member may be actuated to hold the upper member  76  and spindle  78  in a static position relative to base member  74  to provide for the appropriate length of tubing  28 . 
       FIG. 5  illustrates a modified embodiment of the device of  FIGS. 3 and 4 . The device  72 A illustrated in  FIG. 5  has a design similar to that of device  72  but further includes a mounting member  100  to which the base member  74  is releasably attachable. In this embodiment, mounting member  100  is secured to the patient with an adhesive patch  41 . In  FIG. 5 , device  72 A is shown with the base member, central spindle and upper member assembled together and detached from mounting member  100 . Device  72 A may have its base member attached and detached from mounting member  100  while a length of tube  28  is still disposed within toroidal space  79 . 
     The tube-holding portion (e.g., base member, central spindle, upper member, and retainer members) of the device  72 A which is used to manage and secure a length of tubing  28  is detachable from mounting member  100 . The ability to detach the tube-holding portion of the device  72 A from mounting member  100  allows the user to disconnect tube  28  from the connection or insertion hub ( FIGS. 1 and 2 ) and then remove the reservoir  22 , associated delivery device, and tube  28  with the detached tube-holding portion without having to remove tube  28  from the device  72 A. For example, the user may want to perform such a disengagement of the reservoir and pump when taking a bath. By being able to detach the tube-holding portion from the user&#39;s body without disengaging the tube  28  from the device  72 A, the detachment and subsequent re-attachment process is made simpler and more convenient for the user. 
     The releasable securement of the device  72 A with the mounting member  100  may be accomplished using a number of different attachment techniques.  FIGS. 6-9  illustrate one exemplary manner of releasably securing a holding portion  108  to a mounting member  100 . In this embodiment, mounting member  100  includes a ring or collar  102  which extends upwardly from a bottom plate  104 . Bottom plate  104  is readily adapted to have an adhesive layer (e.g., adhesive layer  41  of  FIG. 5 ) disposed on its surface opposite ring  102 . Ring  102  also includes two diametrically opposed L-shaped grooves  106  as illustrated in  FIGS. 6 and 7 . Holding portion  108  of  FIGS. 8 and 9  includes two diametrically opposed tabs  110  that are inserted into grooves  106 . Holding portion  108  is then rotated slightly to firmly engage tabs  110  into grooves  106  and releasably secure holding portion  108  to mounting structure  100 . To remove, holding portion  108  is rotated in the opposite direction to a position that allows the withdrawal of tabs  110  from grooves  106 . 
     For example, in the embodiment of  FIG. 5 , the base member, central spindle, upper member and plurality of retainer members form the holding portion  108  and tabs  110  may be located on the base member  74 . This allows the mounting member  100  to be secured to the patient, for example, by adhesively securing it to the skin of the patient, while the base member, central spindle, upper member and plurality of retainer members, together with a length of flexible tubing, may be selectively secured and detached from the mounting member. 
     A variety of other attachment methods may also be employed. For example, cooperating helical threads, magnetic closures, an alternative bayonet type attachment, cooperating hook and loop patches, or other suitable attachment mechanisms may be employed. 
     Another embodiment of a tube management device for an infusion set having a flexible tube for conveying medication between a reservoir and an infusion site on a patient is illustrated in  FIGS. 10-13 . Device  90  includes a support member  92  which can be secured to the patient. For example, the illustrated support member  92  has a layer of adhesive  136  on one side that can be used to adhesively secure support member  92  to the skin of the patient. Alternative attachment arrangements may also be used, for example, the device may have a clip that can be secured to the belt of the patient to thereby secure the device to the patient. 
     A reel member  94  is detachably mountable on support member  92  and provides a tube-holding portion for device  90 . As further discussed below, a length of flexible tube  28  may be wound on reel member  94 . Reel member  94  is rotatable relative to support member  92  when mounted on support member  92 . Rotation of reel member  94  either retracts or extends the flexible tube  28  depending upon the direction in which reel member  94  is rotated. Reel member  94  is detachable from support member  92  with a section of flexible tubing  28  wound on reel member  94 . As discussed herein, the ability to disengage a device from the patient while tubing  28  is engaged with the device is beneficial such as when the patient takes a bath or shower. Reel member  94  may comprise a single molded component or a plurality of components assembled together. 
     In the illustrated embodiment, support member  92  includes first and second tube guides  96  which loosely grip flexible tube  28  in a manner that allows tube  28  to slide through guides  96  as tube  28  is retracted or extended on reel member  94 . As most easily seen in  FIG. 10 , support member  92  includes two ears  138  that extend outwardly with tube guides  96  disposed thereon. Tube guides  96  are located on opposite sides of reel member  94  when device  90  is fully assembled. Each tube guide  96  is formed by a pair of flexible arms  140  defining a slot  142  therebetween. Tube  28  may be forced through slot  142  to either engage or disengage tube  28  from guide  96 . While the illustrated embodiment utilizes guides  96  that permit tube  28  to slide therethrough, alternative embodiments may employ guides that more tightly grip tube  28  in a manner that inhibits or prevents tube  28  from sliding relative to the guides. As can be seen in the figures, the illustrated tube guides  96  are positioned such that the tube  28  extending through the guides will slide in a direction through the guides along or parallel to a tangential line to the outer perimeter of toroidal space  120  within which tube  28  is wound about reel member  94 . 
     Support member  92  also includes a central outwardly projecting shaft  98  on which the reel member  94  may be mounted. In the illustrated embodiment, reel member  94  includes a socket  112  that mates with shaft  98  to releasably secure reel member  94  on support member  92 . Alternatively, support member  92  may define a socket for engaging a shaft on reel member  94 , or another suitable means of rotatably mounting reel member  94  on support member  92  could be employed. 
     Reel member  94  includes a spindle section  114  and radially extending flanges  116 ,  118  which define a toroidal space  120  for receiving the flexible tube  28  as it is wound on the reel member  94 . Flanges  116 ,  118  are illustratively parallel to each other. Reel member  94  also includes a central passage  122  extending through the spindle section  114  for receiving the flexible tube  28 , as illustrated in  FIGS. 11 and 12 . 
     Central passage  122  defines an open side  124  that extends the full length of the central passage  122  thereby allowing the flexible tube  28  to be laid into the central passage at a non-terminal portion of the flexible tube. As those having ordinary skill in the art will recognize, when reel member  94  is rotated, the engagement of the tube  28  with central passage  122  causes this section of the tube to rotate with reel member  94  and thereby wind tube  28  about the spindle or dispense a previously wound section of tube  28  from the spindle. 
     In the illustrated embodiment, spindle section  114  also defines a hollow interior  126  with the central passage  122  being formed by diametrically opposite open slots  128  in reel member  94 . Slots  128  are in communication with the hollow interior  126 . A plurality of posts  130  are located in the hollow interior  126  such that, when the flexible tube is routed about the plurality of posts  130 , tube  28  is securely gripped by posts  130  to thereby block the sliding movement of tube  28  relative to posts  130 . 
     It is noted that neither socket  112  nor hollow interior  126  extends the full axial height of spindle section  114 . For example, both portions may extend for slightly less than one half the axial height of spindle section  114  with a wall of material separating socket  112  from hollow interior  126  and supporting posts  130 . One of the socket  112  and shaft  98  may include an annular recess with the other one of the socket  112  and shaft  98  including an annular projection that snap fits within the recess to retain the parts together. In this embodiment, the shaft  98  and socket  112  are formed out of a sufficiently flexible and resilient material to allow the two parts to be pulled apart when a moderate force is applied. 
     Reel member  94  includes non-circular section  144  located on the distal surface of top flange  116 . Non-circular section  114  facilitates manual rotation of reel  94  when extending or retracting tube  28  on reel member  94 . This section may also facilitate the attachment of a cap with the cap having a recessed area that mates with non-circular section  144 . Non-circular section  144  is illustratively hexagonal in shape. 
     The illustrated embodiment includes a cap  132  that is detachably securable to the reel member  94 . When cap  132  is secured to reel member  94 , cap  132  surrounds toroidal space  79  that holds the length of tube  28  wrapped about reel member  94 . Cap  132  defines a plurality of circumferentially spaced openings  134  which allow the passage of tube  28  through cap  132 . Openings  134  have an open end whereby a non-terminal portion of tube  28  may be slid into openings  134  to allow passage of tube  28  through cap  132  during attachment of cap  132 . 
       FIG. 13  illustrates cap  132  mounted on reel member  94  with a length of tube  28  wound on reel member  94 . Cap  132  retains the length of tube  28  wound on reel member  94  in toroidal space  120  when cap  132  is attached to reel member  94 . Tube  28  extends through openings  134  at the two points where tube  28  enters/exits reel member  94 . Cap  132  may remain attached to reel member  94  when reel member  94  is secured to support member  92  and when reel member  94  is detached from support member  92 . Arrows  148  in  FIG. 13  indicate that reel member  94  may be attached and detached from support member  92  with a tube  28  wound thereon and a cap  132  secured to reel member  94 . The ability to leave cap  132  on reel member  94  when attaching and detaching reel member  94  from support member  92  provides convenience to the user when removing tube  28  and reel member  94  from their body. Cap  132  may also be removed from reel member  94  when reel member  94  is either attached or detached from support member  92 . 
     The operation of use of device is best understood with reference to  FIGS. 10-13 . When first engaging tube  28  with device  90 , cap  132  is removed and tube  28  is engaged by laying it into central passage  122  through open side  124  and positioning it between posts  130 . Tubing  28  is also engaged with each of the tube guides  96  on opposite sides of central passage  122 . In this regard, it is noted that tube  28  does not have to be threaded through any part of device  90 , and a non-terminal portion of tube  28  may be operably engaged with and disengaged from device  90  while tube  28  is operably connected to convey medication between the reservoir and the infusion site. 
     To wind an excess of tubing onto device  90 , reel member  94  is manually rotated as indicated by arrow  146  in  FIG. 11 . In this regard, it is noted that tube guides  96  are arranged for reel member  94  to be rotated in the counter-clockwise direction as viewed from the top of device  90  to wind additional tubing onto reel member  94 . In alternative embodiments, however, tube guides  96  may be arranged to rotate the reel member in the opposite direction. In still other embodiments, tube guides  96  may be omitted or be rotatable on the support member whereby reel member  94  may be rotated in either direction when starting to wind up tube  28  thereon. 
     In the embodiment of  FIG. 11 , as reel member  94  is rotated in direction  146  to wind tube  28  onto the reel member  94 , tube  28  slides through each of tube guides  96  as it is wound on the reel member as indicated by arrows  147 . Once the desired length of tube  28  has been wound on reel member  94 , cap  132  is attached to reel member  94 . 
     To remove some or all of the tube  28  from the reel member  94 , the cap  132  is removed and reel member  94  is rotated in the direction opposite that indicated by arrow  146  to thereby allow tubing to slide outwardly away from reel member  94  through tube guides  96 . Alternatively, the user may simply grab tube  28  at locations outside tube guides  96  and pull the tubing outwardly which will cause reel member  94  to rotate as tube  28  is extended from the reel member. In some embodiments, it may be possible to pull tube  28  outwardly in this manner while cap  132  is still attached to reel member  94 . Reel member  94  may include a detent system or other mechanism to resist rotating in the unwinding direction unless an outward force applied by the user exceeds a threshold. 
     It is further noted that support member  92  may be secured to the patient when engaging tube  28  with device  90 , or support member  92  may be secured to the patient after winding a length of tube  28  onto device  90 . 
     In one embodiment, a torsional spring may be used to bias reel member  94  relative to support member  92 . Such a spring-biased assembly may be employed to automatically wind up excess tube length. A releasable locking member may be employed to hold the reel member in a static position relative to support member  92  to provide for the appropriate length of tubing  28 . 
     Another embodiment of a tube management device  36  ( FIG. 1 ) for an infusion set having a flexible tube for conveying medication between a reservoir and an infusion site on a patient is illustrated in  FIGS. 14-18 . Tube management device  200  includes an upper member  202 , a base member  206 , and a central spindle  204  positioned between base member  206  and upper member  202 . In the illustrated embodiment, upper member  202  and spindle  204  are rotatably mounted on base member  206 . 
     Base member  206  includes a centrally-positioned post or shaft  208  with a radial post-rim  210  that protrudes radially outwardly beyond the main diameter of post  208 . Post  208  illustratively includes one or more post-cutouts  212  that cut transversely through post  208 , thereby separating post  208  into several (e.g., four) portions each fixed at the bottom to base  206  and that may be flexed radially inward to receive spindle  204 . Base  206  also has a tubing slot  216  cutting transversely through its radial wall  218  for receiving tubing through diametrically opposed portions of wall  218 . Radial wall  218  includes a wall rim  214  extending circumferentially around base member  206  and radially outwardly from wall  218 . 
     Illustratively, central spindle  204  has a generally round or oval outer profile and includes a tubing slot  222  that extends transversely through the center of spindle  204 , providing two diametrically opposed slots  222  for receiving tubing. Walls forming the tubing slots  222  illustratively include fillets  224  at either end having radius R, where R is larger than the minimum bend-radius of the tubing that is inserted into the slots  222 . Spindle  204  also has a central opening  226  extending through the body of spindle  204 . An upper portion of opening  226  serves as a keyhole (illustratively hexagonally shaped) configured to mate with a corresponding feature  236  ( FIG. 18 ) formed on the bottom surface of upper member  202 , as described herein. A lower portion of opening  226  is sized to receive post  208  of base member  206 . Spindle  204  may optionally include a gutter, illustratively a circumferential gutter  228  in  FIG. 16 , which is recessed in the bottom surface of spindle  204 . 
     During manufacturing, spindle  204  is assembled to base member  206  by pushing an interference chamfer  230  ( FIG. 16 ) of spindle  204  down over post rim  210  onto post  208  of base member  206 . An assembled spindle  204  and base member  206  is illustrated in  FIG. 17 . The post-cutouts  212  ( FIG. 14 ) allow post  208  to flex radially inward, thereby securing spindle  204  to base member  206  (and blocking removal) via the interaction of interference chamfer  230  and post rim  210 . 
     Referring to  FIG. 18 , upper member  202  includes keyed feature  236  that mates to the corresponding keyed feature (i.e., lid-keyhole  226 ) in spindle  204 . Upper member  202  also includes a circumferential rim  238  that mates to the wall rim  214  on base member  206 . In one embodiment, at least one of rim  238  and wall rim  214  are adapted to flex radially to facilitate assembly of upper member  202  to base member  206 . 
     In an exemplary method of operation with an infusion set tubing, with upper member  202  removed the user first rotates spindle  204  relative to base member  206  to align tubing slots  216 ,  222 . The user then inserts the infusion set tube through the aligned tubing slots  216 ,  222 . Upper member  202  is then attached to base member  206  by mating rim  238  to wall rim  214 , thereby securing the lid to the base. Feature  236  is aligned with spindle  204  to mate with the top portion of opening  226  of spindle  24 , thereby mechanically coupling spindle  204  to upper member  202 . In the exemplary embodiment, upper member  202  is free to rotate relative to base  206 , and by rotating upper member  202 , spindle  204  is also rotated causing the tubing to be wound around the spindle  204 . To increase the tube length outside device  200 , the user pulls on one or both ends of the tube. 
     Another embodiment of a tube management device  36  ( FIG. 1 ) for an infusion set having a flexible tube for conveying medication between a reservoir and an infusion site on a patient is illustrated in  FIGS. 19 and 20 . Tube management device  300  includes an upper member  302 , a base member  306 , and a central spindle  304  ( FIG. 20 ) integrated with the upper member  302  on the lower or inside surface of upper member  302 . In the illustrated embodiment, upper member  302  and spindle  304  are rotatably mounted on base member  306 . 
     Base member  306  is similar to base  206  of  FIG. 14  but optionally does not include the post  208  of base  206 . In another embodiment, base  306  does include a centrally located post configured to couple to spindle  304 . As illustrated, base  306  has a tubing slot  316  cutting transversely through its radial wall  318  for receiving tubing through diametrically opposed portions of wall  318 . Radial wall  318  includes an outer wall rim  314  extending circumferentially around base member  306  and radially outwardly from wall  318 . 
     Referring to  FIG. 20 , upper member  302  includes an interior circumferential rim  338  that mates to the wall rim  314  on base member  306 . Rim  338  may encircle the full circumference of upper member  302  or, as illustrated in  FIG. 20 , comprise multiple portions each having an arc length. In one embodiment, at least one of rim  338  and wall rim  314  are adapted to flex radially to facilitate assembly of upper member  302  to base member  306 . 
     Central spindle  304  illustratively includes a pair of lobes or posts integrated with and protruding from the bottom surface of upper member  302 . The lobe pair forms a central tubing slot  322  that extends transversely through the center of spindle  304  for receiving tubing. Tubing slot  322  includes tubing retention features  324  formed in the walls of spindle  304 . The walls forming the tubing slot  322  also illustratively include fillets  326  at either end having radius R, where R is larger than the minimum bend-radius of the tubing that is inserted into the slots  322 . 
     In an exemplary method of operation with an infusion set tubing, with upper member  302  removed the user first inserts the infusion set tube through the tubing slot  322  of spindle  304 . Upper member  302  is then attached to base member  306  by mating rim  338  to wall rim  314  while aligning slots  316  and slot  322 , thereby allowing tubing to exit device  300  through slots  316  and securing the lid  302  to the base  306 . In the exemplary embodiment, upper member  302  is free to rotate relative to base  306 , and by rotating upper member  302 , spindle  304  is also rotated causing the tubing to be wound around the spindle  304 . To increase the tube length outside device  300 , the user pulls on one or both ends of the tube. 
     Another embodiment of a tube management device  36  ( FIG. 1 ) for an infusion set having a flexible tube for conveying medication between a reservoir and an infusion site on a patient is illustrated in  FIGS. 21-23 . Tube management device  400  includes an upper member  402 , a base member  406 , and a central spindle  404  positioned between members  402 ,  406 . Base member  406  includes an illustratively circular-shaped adhesive member or patch  407  for securing device  400  to a patient&#39;s skin. 
     Referring to  FIG. 22 , base member  406  includes a radial wall  408  and a radial rim  410 . Base  406  includes a pair of diametrically opposed tubing slots  416  each with a chamfered top end. Base  406  also includes a plurality of drain slots  412  circumferentially spaced around radial wall  408 . For example, these slots  412  facilitate draining such that if a user wears the device in water (e.g. when bathing or swimming), the water has a free path to drain out of the device. Base  406  also has optional radial protrusions  418  serving as finger holds which help a user hold base  406  while lid  402  is rotated relative to base  406 . Finger holds  418  and drain slots  412  may also be provided on devices  200 ,  300  described herein. 
     Spindle  404  has an outer profile that is generally round or oval in shape. Spindle  404  includes a pair of posts  420  divided by a tube slot  422  which may optionally have tubing retention features formed in the walls of the posts  420 , as similarly described herein with respect to features  324  of device  300  in  FIG. 20 . As described with spindle  304  of device  300 , the walls forming tube slot  422  of spindle  404  have fillets at either end having radius R, where R is larger than the minimum bend-radius of the tubing that will be inserted into the slot  422 . In the illustrated embodiment, spindle  404  also includes a bottom circular flange  425  which is smaller (illustratively only slightly smaller) than the inner diameter of base  406  to allow flange  425  to fit within base  406 . Spindle further includes a key-slot opening  424  formed in the posts  420  for mating to a corresponding key feature  440  ( FIG. 23 ) in lid  402 . 
     Upper member  402  has a circumferential lid-rim  442  which may encircle the entire circumference of member  402  (as shown in  FIG. 23 ) or may be broken into segments such that each segment extends for only a portion having an arc length. Upper member  402  also contains a tubing slot  444  and tubing gates  446  which allow a tube to be inserted one way into tubing slot  444  but block or restrict the tube from coming back out of slot  444  without extra force by the user to compress the tube through gates  446 . Tubing slot  444  illustratively extends across the diameter of member  402  with a tubing gate  446  at each end of the slot to retain the tubing in the slot  444 . 
     During manufacturing, the keying feature  440  on member  402  mates with the corresponding keying feature  424  (e.g., keyhole features) on spindle  404  to form a lid/spindle sub-assembly. The lid/spindle sub-assembly is then attached to base member  406  via engagement of rims  410  and  442 . 
     In an exemplary method of operation with an infusion set tubing, the upper member  402 , base member  406 , and spindle  404  are pre-assembled. As such, the user is only required to first align tubing slot  422 ,  444  in the lid/spindle sub-assembly with tubing slots  416  in base  406  prior to inserting the tubing. The user then inserts the tube through tubing slot  444  in lid  402  and down into slots  416  in base  406 . Tubing gates  446  in lid  402  allow the tube to be pushed through (e.g., compressed) into slot  444 , but tubing gates  446  block or restrict the tube from coming back up out of slots  444  and slots  416  in base  406 , as described herein. Lid  402  is free to rotate with respect to base  406 , and by turning lid  402 , the user also turns spindle  404 , causing the tubing wind around spindle  404 . To lengthen the tube outside of device  400 , the user pulls on one or both ends of the tube. 
     The embodiments disclosed herein may have an optional adhesive patch that allows the device to be worn on body. When worn on-body, the devices of the present disclosure also provide strain relief for the insertion site; if the infusion set tube is pulled on the pump side of the device, the strain will be communicated to the tubing management device rather than to the insertion site. 
     In some embodiments, the user may attach the device to his or her body in a reversible manner, so that the entire infusion set may be removed and re-attached without unwinding the tube from the tubing-management device. Such a scheme may be realized in several ways. In one example, a thin hook-and-loop (e.g., Velcro) interface is positioned between the device and an adhesive patch worn on-body. In another example, the device mates with a clip or clasp that is worn on-body, such as illustrated in  FIGS. 10-13 . Other means of securing the device to provide strain relief may also be provided, such as using a belt-clip. 
     The infusion sets described herein may further comprise a drug. In another embodiment, a system may comprise one or more devices including the infusion set and a drug. The term “drug” refers to one or more therapeutic agents including but not limited to insulins, insulin analogs such as insulin lispro or insulin glargine, insulin derivatives, GLP-1 receptor agonists such as dulaglutide or liraglutide, glucagon, glucagon analogs, glucagon derivatives, gastric inhibitory polypeptide (GIP), GIP analogs, GIP derivatives, oxyntomodulin analogs, oxyntomodulin derivatives, therapeutic antibodies and any therapeutic agent that is capable of transport or delivery by the infusion set. The drug as used in the infusion set may be formulated with one or more excipients. The infusion set is operated in a manner generally as described above by a patient, caregiver or healthcare professional to deliver drug to a person. 
     While this invention has been described as having exemplary designs, the present invention may be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles.