Patent Publication Number: US-2021178054-A1

Title: Vial supporter for medicament pump

Description:
RELATED APPLICATIONS 
     This application is a continuation of U.S. application Ser. No. 15/705,983 filed Sep. 15, 2017, which claims the benefit of U.S. Provisional Application No. 62/394,806 filed Sep. 15, 2016, each of which is hereby incorporated herein in its entirety by reference. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates to medical pumps for delivering medicament to a patient and, more specifically, to a vial supporter for securely holding a medicament vial during a cartridge filling process. 
     BACKGROUND OF THE INVENTION 
     There are many applications in academic, industrial, and medical fields that benefit from devices and methods that are capable of accurately and controllably delivering fluids, such as liquids and gases, that have a beneficial effect when administered in known and controlled quantities. Such devices and methods can be particularly useful in the medical field where treatments for many patients include the administration of a known amount of a substance at predetermined intervals. 
     One category of devices for delivering such fluids is that of pumps that have been developed for the administration of insulin and other medicaments for those suffering from both type I and type II diabetes. Some pumps configured as portable infusion devices can provide continuous subcutaneous medicament injection and/or infusion therapy for the treatment of diabetes. Such therapy may include, e.g., the regular and/or continuous injection or infusion of insulin into a person suffering from diabetes and offer an alternative to multiple daily injections of insulin by an insulin syringe or an insulin pen. Such pumps can be ambulatory/portable infusion pumps that are worn by the user and may use replaceable cartridges. Examples of such pumps and various features that can be associated with such pumps include those disclosed in U.S. Patent Application Publication Nos. 2013/0053816, 2013/0324928 and 2013/0331790, and in U.S. Pat. Nos. 8,287,495, 8,573,027 and 8,986,253, each of which is hereby incorporated herein by reference in its entirety. 
     One type of pump that has been developed is a patch pump, or micro pump. Patch pumps generally are small pumps, typically ambulatory, that are carried directly on the skin under the patient&#39;s clothing. Many such pumps are situated directly on the injection site such that no tubing is required to deliver the insulin and/or other medicament to the patient. Other patch pumps can be positioned on the patient&#39;s body with a short length of tubing extending to a nearby infusion site. Not unlike other types of pumps, but perhaps more typically, patch pumps can be at least in part disposable, meant to be worn for a period of time such as, e.g., a day or two, and then discarded and replaced by a new patch pump. Other patch pump designs contemplate a disposable component, such as a cartridge that contains medicament, and a reusable or durable component. In such configurations, the disposable and durable components may be joined together by the patient or caregiver in preparation for delivery of the medicament. 
     Some pumps, including patch pumps, may include medicament cartridges. Such cartridges may be intended for single use only (and thus intended to be filled once) while other cartridges may be intended to be refilled one or more times. Embodiments of the invention disclosed herein cover both such types of cartridge. As such, the terms “fill” and “fellable” should be construed herein to mean cartridges that are intended to be filled once as well as cartridges that are intended to be filled more than once. Moreover, as used herein, the term “fill” encompasses both the act of introducing medicament into a cartridge to its maximum capacity and, in some instances, introducing medicament into a cartridge to less than its maximum capacity. Likewise, the term “fillable” refers to cartridges for use with embodiments of the invention disclosed herein that may be filled to their maximum or to less than their maximum capacity with medicament. To fill a medicament cartridge, a vial or container of medicament typically is coupled to the cartridge of the pump and medicament is transferred from the container to the cartridge. Existing methods of filling pumps can be awkward for a user (patient or caregiver) do to many such cartridges including flexible tubing extending from the cartridge body that is not rigid enough to support a vial of medicament. Thus, users often must carefully hold the cartridge, the container, and any necessary adapters or couplers, while allowing the medicament to transfer from the container to the cartridge. The filling methods are further complicated if the user must assist the cartridge filling process, such as by pulling a fill rod to draw medicament into the cartridge. 
     SUMMARY OF THE INVENTION 
     Devices and methods for filling a medicament cartridge of a pump, including a user-wearable, ambulatory infusion pump. A device for supporting a medicament cartridge can comprise a body portion resembling a tray, with recesses disposed therein to support one or more of a cartridge body, cartridge tubing, interconnect fitting, and vial adapter. The recesses of the tray may be shaped to correspond to that component intended to be placed in its respective recess so to provide a visual indication to a user how to couple and align the various components necessary to fill the cartridge. 
     In one embodiment, a device for supporting a medicament cartridge of an ambulatory infusion pump during a procedure for filling the medicament cartridge with a medicament includes a tray having a cartridge end and a vial end. A cartridge holder can be defined in the tray body adjacent the cartridge end, the cartridge holder comprising a recess in the tray body and having a bottom surface and a perimeter shape generally matching an outer perimeter of a body of the medicament cartridge configured to be retained in the cartridge holder. A fitting holder can be defined in the tray body adjacent the vial end, the fitting holder comprising a recess in the tray body configured to retain an interconnect fitting of the medicament cartridge and having a shape generally matching a shape of the interconnect fitting. A tubing holder can be defined in the tray body, the tubing holder comprising a channel configured to retain a tubing section of the medicament cartridge. In various embodiments, a vial adapter holder can also be defined in the tray body adjacent the fitting holder at the cartridge end of the tray body, the vial adapter comprising a recess in the tray body configured to retain a portion of a vial adapter configured to attach to the interconnect fitting of the medicament cartridge therein. 
     In another embodiment, a system for filling a medicament cartridge of an ambulatory infusion pump with a medicament can include a medicament cartridge and a cartridge supporter. The medicament cartridge can include a cartridge body defining an outer perimeter, a tubing section extending from the cartridge body and an interconnect fitting at a distal end of the tubing section. The cartridge supporter is configured to support the medicament cartridge during a procedure for filling the medicament cartridge with a medicament. The cartridge supporter can define a tray body having a cartridge end and a vial end and include a cartridge holder recess having a perimeter shape generally matching the outer perimeter of the cartridge body, a fitting holder recess having a shape generally matching a shape of the interconnect fitting and a tubing holder channel configured to retain the tubing section. 
     In another embodiment, a method of filling a medicament cartridge utilizing a device for supporting a cartridge and/or a vial of medicament is described. The method can include placing a medicament cartridge having a cartridge body and a fitting connected to a tubing portion extending from the cartridge body into a cartridge supporter configured as a tray. A medicament vial containing a medicament can be connected to a vial adapter connected to the fitting. The medicament cartridge can then be filed with the medicament from the medicament vial with the medicament cartridge in a cartridge holder of the tray. After filling the medicament vial can be disconnected from the vial adapter and the medicament cartridge removed from the tray. The vial adapter can be disconnected from the fitting and, in various embodiments, the medicament cartridge can be connected to an ambulatory infusion pump and infusion set for use or a fitting cap inserted into the fitting to store the cartridge for later use. 
     In a further embodiment, a device for supporting the cartridge and/or a vial of medicament includes a body portion having a means for supporting a tube of the cartridge and a cradle for securely holding a body of the cartridge. The vial supporter may include one or more features that make grasping the supporter easier. The cradle of the vial supporter may include one or more arms which at least partially surround the cartridge when the cartridge is coupled to the vial supporter during a filling procedure. 
     The above summary is not intended to describe each illustrated embodiment or every implementation of the subject matter hereof. The figures and the detailed description that follow more particularly exemplify various embodiments. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Subject matter hereof may be more completely understood in consideration of the following detailed description of various embodiments in connection with the accompanying figures, in which: 
         FIG. 1  is a perspective view of a vial supporter according to an embodiment of the present invention. 
         FIG. 2  is a top plan view of the vial supporter of  FIG. 1 , coupled with a vial adapter, a container of medicament and a fillable cartridge. 
         FIG. 3  is a perspective view of  FIG. 2  without the container of medicament. 
         FIG. 4  is a detail perspective view of the vial supporter of  FIG. 3 . 
         FIG. 5  is a perspective view of a fillable cartridge. 
         FIG. 6  is a perspective view of a vial supporter according to another embodiment of the present invention. 
         FIG. 7  is another perspective view of the vial supporter of  FIG. 6 . 
         FIG. 8  is a perspective view of a cartridge and/or vial supporter according to another embodiment of the present invention, coupled with a vial adapter and a fillable cartridge. 
         FIG. 9  is a view of the underside of  FIG. 8 . 
         FIG. 10  is a detail view of the supporter of  FIG. 8 . 
         FIG. 11  is another perspective view of the supporter of  FIG. 8 . 
         FIG. 12  is a perspective view of a cartridge and/or vial supporter according to another embodiment of the present invention, coupled with a vial adapter and a fillable cartridge. 
         FIG. 13  is an exploded perspective view of the supporter of  FIG. 12 . 
         FIG. 14  is a perspective view of the supporter of  FIG. 12 . 
         FIG. 15  is a perspective view of a vial adapter according to an embodiment of the invention. 
         FIG. 16  is another perspective view of the vial adapter of  FIG. 15 . 
         FIG. 17  is a cutaway side view of the vial adapter of  FIG. 15 . 
         FIGS. 18A-18B  are a flowchart depicting a method of filling a cartridge using a vial supporter, according to an embodiment of the invention. 
         FIGS. 19A-19B and 20A-20B  are perspective views of a cartridge and/or vial supporter according to another embodiment of the present invention. 
         FIG. 20C  is a partial cross-sectional view of a portion of the cartridge and/or vial supporter of  FIGS. 19A-19B and 20A-20B . 
         FIG. 21  is a flowchart depicting a method of filling a cartridge using a cartridge and/or vial supporter according to an embodiment of the present invention. 
         FIG. 22  is a flowchart depicting a method of filling a cartridge using a cartridge and/or vial supporter according to an embodiment of the present invention. 
         FIG. 23  is a flowchart depicting a method of filling a cartridge using a cartridge and/or vial supporter according to an embodiment of the present invention. 
     
    
    
     While various embodiments are 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 claimed inventions 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 subject matter as defined by the claims. 
     DETAILED DESCRIPTION OF THE DRAWINGS 
     The following detailed description should be read with reference to the drawings in which similar elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention. 
     Described herein are devices and methods for securely supporting components associated with fillable cartridges for patch pumps. 
     Referring to  FIGS. 1-4 , one embodiment of a system  100  is depicted, which includes a vial supporter  102   a,  a cartridge  160 , a fill rod  180 , an adapter  190 , and/or a medicament vial  210 . System  100  may include all, or less than all of the components depicted in  FIGS. 1-4 . Vial supporter  102   a  can generally include a body portion  104  having a first end  106 , a second end  108 , and one or more features  110  to facilitate grasping vial supporter  102   a  by a user during a cartridge filling process and provide a guide as to a desired position to grasp supporter  102   a.  First end  106  includes a cartridge cradle  116  or other suitable means configured for receiving a fillable cartridge  160 , and one or more arms  118  or other suitable means configured for coupling with and supporting cartridge  160 . Arms  118  are arranged to facilitate easy installation and removal of cartridge  160  while also securely retaining cartridge  160  during filling. As depicted in  FIGS. 1-4 , each of arms  118  may be uniquely shaped and sized but in other embodiments arms  118  may be symmetrically shaped and/or size, either with respect to an individual arm  118  or between or among two or more arms, in any combination. A stop  120  may be included to help locate cartridge  160  in supporter  102   a  and prevent movement of cartridge  160  toward second end  108  during, e.g., a cartridge filling process. Vial supporter  102   a  may also have one or more features (not pictured) to limit movement of cartridge  160  towards first end  106  during, e.g., a cartridge filling process (when fill rod  180  described below is moved or pulled towards first end  106 ). 
     Second end  108  may include a cradle  112  configured to couple with and support a tubing section  166  of cartridge  160 . Alternately, cradle  112  may be configured to support an interconnect fitting  168  of cartridge  160  in addition to, or instead of, tubing section  166 . As depicted in  FIGS. 1-4 , cradle  112  comprises a raised cradle portion defining an aperture or region  113  into which tubing  166  may be snapped or otherwise put in place. The open area defined by edges  113  of the cradle facilitates grasping or otherwise accessing the fitting  168  or tubing  166  when a user wishes to remove them from vial supporter  102   a.  In addition to a single cradle  112 , multiple cradles may be utilized, and other configurations of element  112  that support and/or hold tubing section  166  and/or interconnect fitting  168  and facilitate grasping the fitting and tubing are within the scope of the invention. 
     Vial supporter  102   a  is configured to securely retain and support cartridge  160  such that cartridge  160  can be easily filled. Body  162  of cartridge  160  is held in cartridge cradle  116  of vial supporter  102   a,  while tubing section  166  is held in cradle  112  of vial supporter  102   a.  A fill rod  180  is coupleable to cartridge  160 , and a vial adapter  190  is coupleable to interconnect fitting  168  of cartridge  160 . Vial adapter  190  facilitates connection between a medicament vial  210  and cartridge  160 . While filling cartridge  160  using vial supporter  102   a,  a user need not grasp or hold vial  210 , as vial  210  is sufficiently held in place with vial supporter  102   a.    
     In operation, vial supporter  102   a  provides a stable and secure arrangement of cartridge  160 , tubing  166 , adapter  190 , and vial  210 , and prevents any misalignment or disconnection between these components while filling cartridge  160 . 
     Cartridge  160  is depicted in  FIG. 5 , and includes body  162 , a reservoir  164 , tubing section  166  and interconnect fitting  168 . Cartridge  160  and/or the embodiments of vial supporters described herein can be configured such that reservoir  164  is visible when cartridge  160  is coupled with a vial supporter, such that a user can determine the level of medicament in cartridge  160  and/or visually inspect for bubbles. During a filling procedure or method, fitting  168  provides a connection for vial  210 . During operation of a pump, fitting  168  provides a connection to a medicament administration set (not depicted). Cartridge  160  also includes a port  170  for fill rod  180 , as best depicted in  FIG. 13 . 
     Referring now to  FIGS. 6-7 , a vial supporter  102   b  is depicted. Vial supporter  102   b  includes components similar to those in vial supporter  102   a  described previously. Thus, vial supporter  102   b  can generally include a body portion  104  having a first end  106  and a second end  108 . First end  106  includes a cartridge cradle  116  or other suitable means configured for receiving a fillable cartridge  160 , and one or more arms  118  or other suitable means configured for coupling with and supporting cartridge  160 . Arms  118  are arranged to facilitate easy installation and removal of cartridge  160  while also securely retaining cartridge  160  during cartridge filling. As depicted in  FIGS. 6-7 , each of arms  118  may be uniquely shaped and sized but in other embodiments arms  118  may be symmetrically shaped and/or sized, either with respect to an individual arm  118  or between or among two or more arms, in any combination. A stop (not pictured) may be included to help locate cartridge  160  in supporter  102   b  and prevent movement of cartridge  160  toward second end  108  during a cartridge filling process. Vial supporter  102   b  may also have one or more features (not pictured) to limit movement of cartridge  160  towards first end  106  during, e.g., a cartridge filling process (when fill rod  180  is moved or pulled towards first end  106 ). 
     Second end  108  may include a cradle  112  configured to couple with and support an interconnect fitting  168  of cartridge  160 . Alternately, cradle  112  may be configured to support a tubing section  166  of cartridge  160  in addition to, or instead of, fitting  168 . As depicted in  FIGS. 6-7 , cradle  112  comprises a raised cradle portion defining an aperture or region  113  into which fitting  168  may be snapped or otherwise put in place. The open area defined by edges  113  of the cradle facilitates grasping or otherwise accessing the fitting  168  or tubing  166  when a user wishes to remove them from vial supporter  102   a.  In addition to a single cradle  112 , multiple cradles may be utilized, and other configurations of element  112  that support and/or hold tubing section  166  and/or interconnect fitting  168  and facilitate grasping the fitting and tubing are within the scope of the invention. 
     Vial supporter  102   b  is configured to securely retain and support cartridge  160  such that cartridge  160  can be easily filled. Body  162  of cartridge  160  is held in cradle  116  of vial supporter  102   b,  while tubing section  166  is held in cradle  112  of vial supporter  102   b.  A fill rod  180  is coupleable to cartridge  160 , and a vial adapter  190  is coupleable to interconnect fitting  168  of cartridge  160 . Vial adapter  190  facilitates connection between a medicament vial  210  and cartridge  160 . While filling cartridge  160  using vial supporter  102   b  with medicament, a user need not grasp or hold vial  210 , as vial  210  is sufficiently held in place by vial supporter  102   b.    
     For any of the embodiments depicted herein, fill rod (or plunger handle)  180  can generally include a handle portion  182  configured for grasping by a user, a shaft portion  184 , and a threaded portion  186  as depicted in, e.g.,  FIG. 13 . 
     Referring now to  FIGS. 8-11 , another embodiment of a cartridge and/or vial supporter  102   c  is depicted. Supporter  102   c  can generally include a tray body  130  having a cartridge end  132  and a vial end  134 , a cartridge holder  136 , a tubing holder  144 , and an interconnect fitting holder  150 . Tray body  130  is shaped to ease handling during the process of filling a cartridge with medicament and, in some embodiments, is configured to be held by a user in a single hand. Cartridge holder  136  comprises a recess, channel, cut-out, relief or similar feature into which a cartridge  160  may be at least partially placed or nested. Cartridge holder  136  is sized and shaped to snugly receive cartridge  160 , including having a perimeter shape generally matching or approximating an outer perimeter shape of the cartridge. Cartridge holder  136  may also define an aperture or window  140  configured to allow visual inspection of reservoir  164  when cartridge  160  is placed in holder  136  as well as to aid in removal of the cartridge by allowing the user to press on that side of the cartridge to urge the cartridge out of the cartridge holder. By visually inspecting cartridge  160 , either through window  140  or the opposite, fully exposed side of the cartridge, a user can determine whether there are air bubbles in the cartridge that need to be removed. In addition, the cartridge can comprise a clear material in the reservoir area where the medicament is contained and can, in some embodiments, include graduated markings delineating volume levels in the reservoir, such that visual inspection can further determine the volume of medicament in the cartridge. Also included in supporter  102   c  is a ring or other similar retention means  142  through which fill rod  180  may be inserted or placed. Ring  142  assists in retaining cartridge  160  securely in place when fill rod  180  is installed because in the depicted embodiment cartridge  160  cannot be removed if the fill rod extends through the ring and is attached to the cartridge. 
     Tubing holder  144  is configured to retain and support tubing section  166  of cartridge  160 , and can generally include a channel or nest  146  and one or more tabs  148 . Channel  146  is preferably sized and shaped to provide a secure fit, such as a “snap” fit, with one or more of a reduced diameter portion  169  of interconnect fitting  168  and a portion  167  of cartridge  160 . To remove tubing  166  from channel  146 , a user may push down on tab  148 , thereby flexing the material and opening channel  146 , allowing tubing  166  to be removed. Interconnect fitting holder  150  may comprise a recess or cradle or one or more other configurations and/or features sized and shaped to receive interconnect fitting  168  of cartridge  160 . Furthermore, interconnect fitting holder  150  can have additional features (not shown) to prevent undesirable rotation of the interconnect fitting  168  when, e.g., a user is detaching interconnect fitting  168  from vial adapter  190  (such as, e.g., by unscrewing). In various embodiments, the recess defining interconnect fitting holder  150  may be contiguous and/or continuous with the channel  146  defining tubing holder, which in turn may be contiguous and/or continuous with the recess defining cartridge holder. Thus, in some embodiments, a single continuous recess may define all of the respective holders, with a varying outer perimeter that matches the shape of the respective component held in each of the holders (additionally optionally including vial adapter holder  151 , discussed below with respect to  FIGS. 19-20 ) and/or a varying depth based on the respective component. 
     Each of cartridge holder  136 , tubing holder  144 , and interconnect fitting holder  150  is configured to provide a user with the ability readily to perform a quick visual and/or tactile confirmation that cartridge  160  and associated components are properly positioned and aligned before beginning a cartridge filling process. While filling cartridge  160  using supporter  102   c,  a user need not grasp or hold vial  210 , as vial  210  is sufficiently held in place with supporter  102   c.  This results in significant improvement in the user&#39;s experience by reducing the complexity and increasing the simplicity of a key aspect of using medicament pumps as described herein. 
     Referring now to  FIGS. 12-14 , a cartridge and/or vial supporter  102   d  is depicted. Supporter  102   d  includes many components similar to those associated with supporter  102   c  described previously. Thus, supporter  102   d  can generally include a tray body  130  having a cartridge end  132  and a vial end  134 , a cartridge holder  136 , a tubing holder  144 , and an interconnect fitting holder  150 . Cartridge holder  136  comprises a recess, channel, cut-out, relief or similar feature into which a cartridge  160  may be at least partially placed or nested. Cartridge holder  136  is sized and shaped to snugly received cartridge  160 . Cartridge holder  136  may also include an aperture or window  140  which is configured to allow visual inspection of reservoir  164  when cartridge  160  is placed in holder  136 . Also included in supporter  102   d  is a ring or other similar retention means  142  through which shaft  184  of fill rod  180  may be inserted or placed. Ring  142  cooperates with fill rod  180  to retain cartridge  160  securely in place when fill rod  180  is installed. 
     Tubing holder  144  is configured to retain and support tubing section  166  of cartridge  160 , and can generally include a channel or nest  146  and one or more tabs  148 . Channel  146  is preferably sized and shaped to provide a secure fit with tubing  166 . To remove tubing  166  from channel  146 , a user may push down on tab  148 , thereby flexing the material and opening channel  146 , allowing tubing  166  to be removed. Tabs  148  as shown in  FIGS. 12-14  can clip over one or more of an end portion  167  of the cartridge  160  and an end portion  169  of the interconnect fitting  168  to securely hold one or both components in place. Downward pressure on tabs  148  can release the components secured therein. Interconnect fitting holder  150  may comprise a recess or cradle (which may or may not be contiguous with channel or nest  146 ), or other similar configuration which is sized and shaped to receive interconnect fitting  168  of cartridge  160 . In some embodiments, the fitting holder  150  can be shaped to prevent turning of the interconnect fitting  168  when it is disposed in the fitting holder  150 . 
     Each of cartridge holder  136 , tubing holder  144 , and interconnect fitting holder  150  is configured to provide a user with the ability readily to perform a quick visual and/or tactile confirmation that cartridge  160  and associated components are properly positioned and aligned before beginning a cartridge filling process. This results in significant improvement in the user&#39;s experience and reduces the complexity and simplicity of a key aspect of using medicament pumps as described herein. While filling cartridge  160  using supporter  102   d,  a user need not grasp or hold vial  210 , as vial  210  is sufficiently held in place with supporter  102   d.    
     Referring now to  FIGS. 15-17 , an embodiment of a vial adapter  190  is depicted. This embodiment can generally include a vial end  192 , and a cartridge end  202 , a bore  194  for receiving vial  210 , a retention feature  196  disposed within bore  194 , a needle  198  for puncturing vial  210  and allowing fluid such as medicament to flow therethrough, and one or more reliefs  200 . Cartridge end  202  includes a vial adapter fitting  204  configured for coupling to the fitting  168  of cartridge  160  and a bore  206  which may be straight or tapered so to improve sealing when vial adapter  190  is coupled with fitting  168 . Other profiles of bore  206 , including combinations of straight and tapered and/or curved profiles, may be used as desired. Fitting  204  may be a Luer-type fitting, a proprietary fitting, or other desired style of fitting. In use, vial  210  is placed into bore  194 , engaging with retention feature  196 . Reliefs  200  allow vial adapter  190  to flex slightly when vial  210  is installed or removed, thus facilitating secure use. 
       FIGS. 19A-19B and 20A-20B  depict another embodiment of a cartridge and/or vial supporter  102   e.  Similar to the embodiment of, e.g.,  FIGS. 8-11 , supporter  102   e  is configured with a tray body  130  having a cartridge end  132  and a vial end  134 . Tray body  130  includes cartridge holder  136  configured to contain a cartridge  160  therein, a tubing holder  144  and a fitting holder  150 . Each of these components is configured and functions substantially similarly to the embodiments described above. In addition, tray  130  includes a vial adapter holder  151  defined by a recess, channel, cut-out, relief or similar feature at vial end  134  of trail body  130  adjacent fitting holder  150  and adapted to receive a fitting end  191  of a vial adapter  190 . Because fitting end  191  of vial adapter  190  is configured to connect to the interconnect fitting  168  of cartridge, vial adapter holder  151  will generally be positioned adjacent the fitting holder  150  at vial end  134  of tray body  130 . In some embodiments, vial adapter holder  151  can be formed contiguously and/or continuously with interconnect fitting holder  150 . In various embodiments, vial adapter holder  151  can be provided with a configuration that prevents rotation of vial adapter  190  and thereby prevents unscrewing of fitting end  191  of the vial adapter  190  from cartridge fitting  168  when the components are nested in the tray body  130 . In the depicted embodiment, fitting end  191  of the vial adapter is provided with a hexagonal configuration and vial adapter holder  151  has a corresponding partial-hexagonal shape matching the configuration of the fitting end to prevent such rotation, but in other embodiments any other matching shapes that prevent rotation could be used. 
     Also in the embodiment depicted in  FIGS. 19A-20B , a fitting retention tab  148  interfaces with interconnect fitting  168  to retain the fitting in the tray body  130 . Fitting  168  can be press fit into fitting holder  150  to form an audible “snap” fit as described above with fitting retention tab  148  physically engaging fitting  168  to hold fitting  168  in fitting holder  150 . This physical engagement can then be released by pressing on fitting retention tab  148  to enable removal of fitting  168  from fitting holder  150 . This embodiment also includes a cartridge retention tab  149 , which can be seen in the partial cross-sectional view of  FIG. 20C . When cartridge  130  is inserted into cartridge holder  136 , a bottom wall portion  147  of cartridge is seated beneath cartridge retention tab  149 . This prevents direct upward movement of cartridge  160  out of cartridge holder  136 . Cartridge  160  can be removed by first tilting the opposite end of cartridge  160  (adjacent the tubing portion  144 ) upward, and then sliding bottom wall portion  147  away from cartridge retention tab  149 . Fitting retention tab or tabs  148 , along with cartridge holder  136  and cartridge retention tab  149  and/or the combination of fill rod  180  and ring  142  (in embodiments described above), generally prevent both forward and backward movement and upward movement of the components contained in tray body  130  during the cartridge filling process. 
     Still referring to  FIGS. 19A-20B , cartridge  160  further includes a fitting cap  161 . In some embodiments, plug  165  of fitting cap  161  can be inserted onto cartridge fitting  168  by pressing or rotating cap  163  of fitting cap  161  after the cartridge has been filled with medicament and removed from supporter  102   e  to seal the cartridge to prevent leakage of medicament if the cartridge is going to be stored and not immediately connected to a pump. Supporter  102   e  also provides a fitting cap holder  153  that includes a recess  155  into which cap  163  of fitting cap  161  fits and a slot  157  into which plug  165  of fitting cap  161  is received. A portion of plug  165 , as shown in  FIG. 19 , extends through supporter  102   e  such that fitting cap  161  can be removed from supporter  102   e  by a user pushing down on plug  165  from that side. In prior art systems that utilize a similar fitting cap, the cap is generally provided loosely in the system packaging and, as such, can easily fall out and become lost, contaminated, etc. upon opening the packaging. One advantage of having a fitting cap holder  153  in the tray body  130  in embodiments of the present invention is that when the device is initially removed from the packaging, the fitting cap  161  is secured to the tray body and can therefore be both easily located for use and prevented from falling out. 
     Referring now to  FIGS. 18A and 18B , a method  208  for filling a medicament cartridge of an ambulatory, user-wearable infusion pump according to an embodiment of the invention is depicted and described. Generally, the method includes coupling the cartridge to a vial supporter and to a vial. Example vial supporters suitable for use with such a method are depicted in  FIGS. 1-4 and 6-7 . With the fill rod retracted, air is pushed into the cartridge. The components are then arranged such that the vial is the highest point, and the fill rod is retracted to draw medicament from the vial into the cartridge. The vial can be removed from the adapter, and the adapted removed from the interconnect fitting of the cartridge. The cartridge can then be attached to an infusion set, and the fill rod and vial supporter are uncoupled from the cartridge and placed aside until the cartridge needs to be filled again. 
     Referring now to  FIG. 21 , a method  210  for filling a medicament cartridge of an ambulatory, user-wearable infusion pump according to another embodiment is depicted and described. Example cartridge and/or vial supporters suitable for use with the depicted method include, for example, the cartridge and/or vial supporters shown in  FIGS. 8-11, 12-14 and 19A-20C . Method  210  includes connecting a vial adapter to an interconnect fitting of a medicament cartridge at step  212 , such as shown in, for example,  FIG. 13 . The cartridge, including a tubing portion extending from cartridge and the interconnect fitting, and connected vial adapter can then be seated in a supporter configured as a tray at step  214  as described above. The tray can include recessed holders defined therein that are sized and shaped to receive the cartridge, tubing portion and interconnect fitting. In some embodiments, the tray also includes a vial adapter holder that retains a portion of the vial adapter. In some embodiments, one or more of a portion of cartridge and a portion of interconnect fitting can create a snap fit with one or more tabs on tray to aid in retaining those components in the tray. A fill rod can then be inserted through a portion of the tray and connected to the cartridge at step  216 , although in the embodiment depicted in  FIGS. 19A-19B and 20A-20C  the fill rod can be inserted either prior to or after seating the cartridge in the cartridge holder. Such a seated configuration is shown in, for example,  FIGS. 8-12 and 19-20 . In some embodiments, the system may come pre-packaged in this configuration before initial use of the cartridge. When the cartridge is refilled, steps  212 - 216  must be repeated. 
     Once the cartridge is in the above-described filling configuration in the tray, at step  218  the fill rod can be positioned to set a desired fill volume. A vial containing the medicament that is to be infused into the cartridge can then be attached to the vial adapter at step  220 , though it should be noted that the vial could alternatively be connected to the vial adapter at any earlier portion of the method. The cartridge can then be filled with the desired volume of the medicament at step  222  and the vial removed. As further described and depicted in  FIGS. 18A-18B , filling the cartridge can include depressing the fill rod to push air into the cartridge, then retracting the fill rod to fill the cartridge with the desired amount, and then checking for air bubbles in the cartridge before removing the vial. In some embodiments, the cartridge can comprise a clear material in the reservoir area where the medicament is contained and the tray can include a rear opening, such as opening  140  described above, to aid in inspecting the cartridge for air bubbles as well as observing the volume of medicament in the cartridge. The cartridge, fill rod and vial adapter can be removed from the tray at step  224 . In some embodiments, the cartridge removal can be aided by one or more tabs that release portions of the system that were snap fit into the tray as described above. In embodiments employing a rear opening for visual inspection of the cartridge, this opening can further aid in cartridge removal by providing easy access for the user to press on the cartridge to push it out of the tray. It should be noted that in embodiments such as those depicted in  FIGS. 8-14  in which ring  142  cooperates with fill rod  180  to retain the cartridge in tray  130 , fill rod  180  must first be removed prior to removing the cartridge and vial adapter. Following removal of the cartridge from the tray, the vial adapter can be disconnected from the interconnect fitting at step  226 . 
     The cartridge is now filled and is readied for use by pushing the fill rod so that a drop of medicament such as insulin is visible at the top of the interconnect fitting and an infusion set attached to interconnect fitting at step  228 . The fill rod can then be removed at step  230 . The cartridge can now be attached to a user-wearable, ambulatory infusion pump at step  232 . Alternatively, if the cartridge is not going to be stored rather than immediately attached to a pump, a fitting cap such as fitting cap  161  can be inserted into interconnect fitting of cartridge rather than attaching the fitting to an infusion set to preclude accidental leakage of fluid from cartridge. 
     Referring now to  FIG. 22 , a method  240  for filling a medicament cartridge of an ambulatory, user-wearable infusion pump according to another embodiment is depicted and described. The depicted method is suitable for use with, for example, the cartridge and/or vial supporters shown in  FIGS. 8-11, 12-14 and 19A-20C . In this embodiment, tray body  130 , vial adapter  190  and cartridge  160  (and fill rod  180 ) are provided to the user pre-assembled. At step  242 , the user removes this pre-assembled combination from the product packaging, sets the desired fill volume with the fill rod at step  243  and connects a medicament vial to the vial adapter at step  244 . After pushing air into the medicament vial with the fill rod at step  245 , the cartridge is then filled with medicament at step  246  as described above and the vial removed from the vial adapter at step  248 . The cartridge and vial adapter can then be removed from the tray at step  250  followed by removal of the vial adapter from the cartridge at step  252 . The fill rod is then pushed so that a drop of medicament such as insulin is visible at the tip of the fitting at step  254  and the fill rod removed from the cartridge at step  256  as described above. The filled cartridge can now be attached to the pump or stored for later use at step  258 . 
       FIG. 23  depicts another method  270  for filling a medicament cartridge of an ambulatory, user-wearable infusion pump according to an embodiment of the infusion with a cartridge and/or vial supporter configured as a tray. Unlike the method  240  described with respect to  FIG. 22  in which components of the system are provided to the user pre-assembled, in this embodiment the user must assemble the cartridge components for filling. Such a procedure may occur when a user is refilling a cartridge after one or more initial uses. At step  272  the vial adapter is connected to the interconnect fitting of the cartridge and at step  274  the fill rod is connected to the cartridge. This assembly can then be placed into the cartridge tray at step  276 . The fill rod can be set for a desired fill volume at  277  and the medicament vial can be connected to the vial adapter at step  278 . Air can be pushed into the medicament vial with the fill rod at step  279  and the cartridge filled with medicament at step  280 . The medicament vial is then removed from the vial adapter at step  282  and the cartridge assembly removed from the tray at step  284 . The filled cartridge can then be readied for use as described previously by removing the vial adapter from the interconnect fitting at step  286 , pushing the fill rod so that a drop of medicament such as insulin is visible at the tip of the fitting at step  288  and removing the fill rod at step  290 . The filled cartridge is now ready to be attached to a pump (and infusion set) or stored for later use, as described herein, at step  292 . 
     Also incorporated herein by reference in their entirety are commonly owned U.S. Pat. Nos. 8,287,495; 8,408,421 8,448,824; 8,573,027; 8,650,937; 8,986,523; 9,173,998; 9,180,242; 9,180,243; 9,238,100; 9,242,043; 9,335,910; 9,381,271; 9,421,329; 9,486,171; 9,486,571; 9,492,608; 9,503,526; 9,555,186; 9,565,718; 9,603,995; 9,669,160; 9,715,327; 9,737,656; and 9,750,871 commonly owned U.S. Patent Publication Nos. 2009/0287180; 2012/0123230; 2013/0053816; 2014/0276419; 2014/0276420; 2014/0276423; 2014/0276531; 2014/0276556 2014/0276569; 2014/0276570; 2014/0378898; 2015/0073337; 2015/0182693; 2016/0082188; 2016/0339172; 2017/0049957; 2017/0142658; 2017/0182248; and 2017/0250971 and commonly owned U.S. patent application Ser. Nos. 14/707,851 and 15/564,895 and commonly owned U.S. Provisional Application Serial Nos. 61/911,576; 61/920,902; 61/920,914; 61/920,940; 62/139,275; 62/352,164; 62/445,041; and 62/545,228. 
     Further incorporated by reference herein in their entirety are U.S. Pat. Nos. 8,601,465; 8,502,662; 8,452,953; 8,451,230; 8,449,523; 8,444,595; 8,343,092; 8,285,328; 8,126,728; 8,117,481; 8,095,123; 7,999,674; 7,819,843; 7,782,192; 7,109,878; 6,997,920; 6,979,326; 6,936,029; 6,872,200; 6,813,519; 6,641,533; 6,554,798; 6,551,276; 6,295,506; and 5,665,065. 
     Various embodiments of systems, devices, and methods have been described herein. These embodiments are given only by way of example and are not intended to limit the scope of the claimed inventions. It should be appreciated, moreover, that the various features of the embodiments that have been described may be combined in various ways to produce numerous additional embodiments. Moreover, while various materials, dimensions, shapes, configurations and locations, etc. have been described for use with disclosed embodiments, others besides those disclosed may be utilized without exceeding the scope of the claimed inventions. 
     Persons of ordinary skill in the relevant arts will recognize that the subject matter hereof may comprise fewer features than illustrated in any individual embodiment described above. The embodiments described herein are not meant to be an exhaustive presentation of the ways in which the various features of the subject matter hereof may be combined. Accordingly, the embodiments are not mutually exclusive combinations of features; rather, the various embodiments can comprise a combination of different individual features selected from different individual embodiments, as understood by persons of ordinary skill in the art. Moreover, elements described with respect to one embodiment can be implemented in other embodiments even when not described in such embodiments unless otherwise noted. 
     Although a dependent claim may refer in the claims to a specific combination with one or more other claims, other embodiments can also include a combination of the dependent claim with the subject matter of each other dependent claim or a combination of one or more features with other dependent or independent claims. Such combinations are proposed herein unless it is stated that a specific combination is not intended. 
     Any incorporation by reference of documents above is limited such that no subject matter is incorporated that is contrary to the explicit disclosure herein. Any incorporation by reference of documents above is further limited such that no claims included in the documents are incorporated by reference herein. Any incorporation by reference of documents above is yet further limited such that any definitions provided in the documents are not incorporated by reference herein unless expressly included herein. 
     For purposes of interpreting the claims, it is expressly intended that the provisions of 35 U.S.C. § 112(f) are not to be invoked unless the specific terms “means for” or “step for” are recited in a claim.