Abstract:
Multicomponent infusion device assemblies include locking and unlocking mechanisms that allow for locking and unlocking of components via actions capable of being carried out by at least some patients suffering from movement disorders. Tools or disengagement components may be used to unlock or disengage the components.

Description:
RELATED APPLICATION 
       [0001]    This application claims the benefit of U.S. Provisional Patent Application No. 61/834,986, filed Jun. 14, 2014, which application is hereby incorporated herein by reference in its entirety to the extent that it does not conflict with the present disclosure. 
     
    
     TECHNICAL FIELD 
       [0002]    The present disclosure relates generally to wearable infusion devices, such as patch pumps, for transcutaneous or transdermal delivery of therapeutic agents to patients; more particularly to modular external infusion device assemblies having a reusable portion and a disposable portion. 
       BACKGROUND 
       [0003]    Wearable external infusion devices and systems are relatively well known in the medical arts for use in delivering or dispensing a prescribed medication to a patient. In one form, such devices comprise a relatively compact pump housing adapted to receive a syringe or reservoir carrying a prescribed medication for administration to the patient through infusion tubing and an associated catheter or infusion set. 
         [0004]    Modular wearable external devices have been described where a portion housing a pumping mechanism is reusable and a portion housing a reservoir is disposable. The portion housing the reservoir is releasably securable to the portion housing the reservoir. The portion housing the reservoir may be swapped out for a new portion housing a reservoir filled with fresh therapeutic agent when the reservoir is empty or becomes nearly empty, when the therapeutic agent in the housing has exceeded its shelf life, etc. Examples of multi-component wearable infusion pump assemblies having disposable and reusable components are described in, for example, U.S. Patent Application Publication No. 2009/0281497, published on Nov. 12, 2009 and entitled WEARABLE PUMP ASSEMBLY, which patent application is hereby incorporated herein by reference in its entirety to the extent that it does not conflict with the disclosure presented herein. 
         [0005]    In some forms, modular external infusion devices having releasably securable components require a good deal of dexterity to lock and unlock the components. For certain patient populations, such as those having diabetes, the locking mechanism and actions required to lock and unlock the components (e.g., to swap out an older component housing a reservoir with a newer component housing a reservoir with fresh therapeutic agent) present little challenge. However, for other patient populations, including patients that suffer from movement disorders such as Parkinson&#39;s disease, the locking and unlocking mechanisms and actions required to lock and unlock components can present significant challenges. 
       SUMMARY 
       [0006]    In various embodiments described herein, multicomponent infusion device assemblies, among other things, have locking and unlocking mechanisms that may be activated by relatively simple actions. In some embodiments, such actions are capable of being carried out by at least some patients suffering from movement disorders. 
         [0007]    In various embodiments, the multicomponent infusion device assemblies described herein, among other things, have unidirectional locking mechanisms and unidirectional unlocking mechanisms. 
         [0008]    In various embodiments, a wearable infusion device assembly includes a first component forming a first portion of a housing of the assembly and comprising an inwardly deflectable element. The wearable infusion device assembly also includes a second component forming a second portion of the housing of the assembly and comprising an engagement element comprising (i) a tapered portion configured to cause the inwardly deflectable element of the first component to deflect inwardly as the second component is advanced about the first component and (ii) a shoulder distal to the tapered portion. The inwardly deflectable element of the first component is configured to deflect outwardly after the shoulder passes the inwardly deflectable element as the second component is advanced about the first component. The shoulder and the inwardly deflectable element are configured to cooperate to prevent withdrawal of the second component over the first component after the inwardly deflectable element of the first component has deflected outwardly after the shoulder has passed the inwardly deflectable element as the second component is advanced about the first component. In some embodiments, the assembly includes a disengagement component configured to advance over the second component towards the first component, the disengagement component having a disengagement element comprising a tapered portion configured to cause the inwardly deflectable element of the first component to deflect inwardly as the disengagement component is advanced about the first component. The tapered portion of the disengagement element is configured to sufficiently inwardly deflect the inwardly deflecting element to allow the second component to be withdrawn over the first component. In some embodiments, a system includes the wearable infusion device assembly and a disengagement tool configured to advance over the second component towards the first component, the disengagement tool having a disengagement element comprising a tapered portion configured to cause the inwardly deflectable element of the first component to deflect inwardly as the disengagement tool is advanced about the first component. The tapered portion of the disengagement tool is configured to sufficiently inwardly deflect the inwardly deflecting element to allow the second component to be withdrawn over the first component. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0009]      FIGS. 1A-B  are schematic drawings of side views of an embodiment of a multicomponent infusion device assembly in an unlocked or disengaged ( 1 A) and locked or engaged ( 1 B) configurations. 
           [0010]      FIGS. 2A-C  are schematic drawings of side views of an embodiment of a system including a multicomponent infusion device assembly and a tool for unlocking or disengaging components of the infusion device assembly. 
           [0011]      FIG. 3  is a schematic drawing of a side view of an embodiment of a component of a multicomponent infusion device assembly. 
           [0012]      FIG. 4  is a schematic drawing of a top view of an embodiment of an inwardly deflecting element. 
           [0013]      FIG. 5  is a schematic side view of an embodiment of a component as shown in  FIG. 3  including the inwardly deflecting element as shown in  FIG. 4 . 
           [0014]      FIG. 6  is a schematic side view of an embodiment of an engagement element of a component (such as the upper component shown in  FIG. 1A ) of a multicomponent infusion device assembly. 
           [0015]      FIG. 7  is a schematic side view of an embodiment of a disengagement element of a disengagement component or tool (such as shown in  FIGS. 2A-C ). 
           [0016]      FIGS. 8A-C  are schematic side views showing interaction of an embodiment of an engagement element of one component of a multicomponent infusion device assembly with an embodiment of an inwardly deflectable element of another component of the infusion device assembly to secure the two components relative to one another. 
           [0017]      FIGS. 9A-B  are schematic side views showing interaction of an embodiment of an disengagement element of a disengagement component or tool with an embodiment of an inwardly deflectable element of a component of an infusion device assembly to allow disengagement of the component the infusion device assembly from another component. 
           [0018]      FIG. 10  is a schematic drawing of a top view of an embodiment of an inwardly deflectable element. 
           [0019]      FIG. 11  is a schematic drawing of a perspective view of an embodiment of a component of a multicomponent infusion device assembly. 
           [0020]      FIG. 12  is a schematic drawing of a perspective view of an embodiment of a component of a multicomponent infusion device assembly. 
           [0021]      FIG. 13  is a schematic drawing of a perspective view showing the component of  FIG. 11  secured or locked relative to the component of  FIG. 12 . 
           [0022]      FIG. 14  is a schematic drawing of a perspective view of an embodiment of a disengagement tool. 
           [0023]      FIG. 15  is a schematic drawing of a perspective view of the tool of  FIG. 14  interacting with the components shown in  FIG. 13 . 
           [0024]      FIG. 16  is a schematic drawing of a top view of an embodiment of a disengagement tool disposed over an embodiment of a multicomponent infusion device assembly. 
           [0025]      FIG. 17  is a schematic drawing of a perspective view of an embodiment of a disengagement tool disposed over an embodiment of a multicomponent infusion device assembly. 
           [0026]      FIG. 18  is a schematic drawing of a bottom view of an embodiment of a disengagement tool disposed over an embodiment of a multicomponent infusion device assembly. 
       
    
    
       [0027]    The schematic drawings in are not necessarily to scale. Like numbers used in the figures refer to like components, steps and the like. However, it will be understood that the use of a number to refer to a component in a given figure is not intended to limit the component in another figure labeled with the same number. In addition, the use of different numbers to refer to components is not intended to indicate that the different numbered components cannot be the same or similar. 
       DETAILED DESCRIPTION 
       [0028]    In the following detailed description, reference is made to the accompanying drawings that form a part hereof, and in which are shown by way of illustration several specific embodiments of devices, systems and methods. It is to be understood that other embodiments are contemplated and may be made without departing from the scope or spirit of the present disclosure. The following detailed description, therefore, is not to be taken in a limiting sense. 
         [0029]    All scientific and technical terms used herein have meanings commonly used in the art unless otherwise specified. The definitions provided herein are to facilitate understanding of certain terms used frequently herein and are not meant to limit the scope of the present disclosure. 
         [0030]    As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” encompass embodiments having plural referents, unless the content clearly dictates otherwise. 
         [0031]    As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise. 
         [0032]    As used herein, “have”, “having”, “include”, “including”, “comprise”, “comprising” or the like are used in their open ended sense, and generally mean “including, but not limited to”. It will be understood that “consisting essentially of”, “consisting of”, and the like are subsumed in “comprising” and the like. 
         [0033]    Any direction referred to herein, such as “top,” “bottom,” “left,” “right,” “upper,” “lower,” “above,” below,” and other directions and orientations are described herein for clarity in reference to the figures and are not to be limiting of an actual device or system or use of the device or system. Many of the devices, articles or systems described herein may be used in a number of directions and orientations. 
         [0034]    Referring now to  FIGS. 1A-B , schematic side views of a multicomponent infusion device assembly  100  are shown. The assembly  100  includes a second component  200  and a first component  300  that is releasably securable relative to the second component  200 . In  FIG. 1A  the components  200 ,  300  are separated, and in  FIG. 1B  the components are secured or locked relative to each other, which occurs by advancing the second component  200  over the first component  300 . Each of the first  300  and second components  200  form a portion of the housing of the assembly  100  when assembled or secured relative to each other. 
         [0035]    The depicted first component  300  includes an inwardly deflectable element  310  to assist in securing the first component  300  relative to the second component  200  as, for example, described in more detail below. The depicted first component  300  also includes a bottom flange  320 . 
         [0036]    The depicted second component  200  includes a plurality of engagement elements  210  that cooperate with the inwardly deflecting element  310  of the second component to secure the first component relative to the second component as will be described in more detail below. The depicted second component  300  also includes channels  220  for receiving disengagement elements of a disengagement tool or component as will be described in more detail below. 
         [0037]    The first component  300  or the second component  200  may include a reservoir for housing a therapeutic agent. The first component  300  or the second component  200  may include a pumping mechanism for delivering the therapeutic agent within the reservoir to the patient. The component comprising the pumping mechanism may also include electronics for operating or controlling the pumping mechanism. 
         [0038]    Either of the first component  300  or the second component  200  may be reusable or disposable. In some embodiments, the component that comprises the reservoir is disposable. In some embodiments, the component that comprises the pumping mechanism is reusable. 
         [0039]    Referring now to  FIGS. 2A-C , schematic drawings of side views are shown of an embodiment of a system including a multicomponent infusion device assembly  100  and a tool  400  for unlocking or disengaging components  200 ,  300  of the infusion device assembly  100 . The depicted tool  400  includes a plurality of disengagement members  410  extending from a generally tubular body  420 . 
         [0040]    In  FIG. 2A , the components  200 ,  300  of the infusion device assembly  100  are locked together. The disengagement tool  400  is advanced over the second component such that the disengagement elements  410  are received by the channels  220  until the disengagement elements  410  contact the flange  310  of the first component. The disengagement elements  410  disengage the inwardly deflecting element  310  of the first component from the engagement elements  210  of the second component such that the second component  300  may be withdrawn over the first component  200  ( FIG. 2C ). 
         [0041]    Referring now to  FIG. 3-5 , a schematic side view of an embodiment of a first component  300  is shown ( FIG. 3 ), a schematic top view of an embodiment of an inwardly deflectable element  310  ( FIG. 4 ) is shown, and a schematic side view is shown of an embodiment of a component  300  as shown in  FIG. 3  including the inwardly deflecting element  310  as shown in  FIG. 4 . The first component  300  includes a recess  330  configured to receive the inwardly deflecting element  310 . The recess  330  includes an interior sidewall  335 . The inwardly deflectable element  310  includes one or more biasing elements  315  that bias the inwardly deflectable element  310  towards an outwardly extending configuration. 
         [0042]    Referring now to  FIG. 6 , a schematic side view of an embodiment of an engagement element  210  (such as an engagement element of the second component as shown in  FIG. 1A ) is shown. The engagement element  310  has a distal end  212  and a tapered portion  215  that tapers outwardly from the distal end  212 . Proximal to the tapered portion  215 , the engagement element  210  has a shoulder  217  that forms a portion of a groove  219  configured to receive an inwardly deflecting element of a first component (not shown in  FIG. 6 ). 
         [0043]    Referring now to  FIG. 7 , a schematic side view of an embodiment of a disengagement element  410  (such as a disengagement element of a disengagement tool as shown in  FIG. 2A ) is shown. The disengagement element  410  has a distal end  412  and a tapered portion  415  that extends outwardly from the distal end. Proximal to the tapered portion  415 , the disengagement element  410  includes a retention portion  417  configured to retain an inwardly deflecting element (not shown in  FIG. 7 ) of a first component in an inwardly deflected position. 
         [0044]    Referring now to  FIGS. 8A-C , locking interaction of a first component with a second component are shown. For purposes of clarity, interaction of only one engagement element  210  of a second component (e.g., second component  200  shown in  FIG. 1A ) with a first component  300  is shown. The second component (as indicated by the engagement element  210 ) is shown advancing over the first component  300  from  FIG. 8A  to  FIG. 8C . As shown between  FIG. 8A  and  FIG. 8B , the tapered portion  215  of the engagement element  210  engages the inwardly deflecting element  310  as the second component is advanced over the first component  300 , causing the inwardly deflecting element  310  to deflect inwardly. Continued advancement of the second portion over the first portion  300  until the shoulder  217  of the engagement element  210  has passed the inwardly deflecting element  310  allows the inwardly deflecting element  310  to deflect outwardly towards its biased or natural state. Once the inwardly deflecting element  310  has deflected outwardly, withdrawal of the second component over the first component is prevented by interaction of the inwardly deflecting element  310  and the shoulder of the engagement element  210 . As shown in  FIG. 8C , further advancement of the second component over the first component  310  is prevented by interaction of the engagement element  210  and the bottom flange  320  of the first component  300 . 
         [0045]    Referring now to  FIGS. 9A-B , unlocking first and second components of an infusion device assembly with an unlocking tool is shown. For purposes of clarity, interaction of only one engagement element  210  of a second component (e.g., second component  200  shown in  FIG. 1A ) with a first component  300  is shown, and only one disengagement member  410  of a tool (such as disengagement tool  400  as shown in  FIG. 2A ) is shown. In  FIG. 9A , the first component  300  is secured relative to the second component via interaction of the outwardly deflected inwardly deflected element and the shoulder of the engagement element  210  (e.g., as depicted and described above with regard to  FIG. 8C ). 
         [0046]    Advancement of the tool over the second component (e.g., as depicted and described above with regard to  FIG. 2 ) causes the tapered portion  415  of the disengagement element  410  to inwardly deflect the inwardly deflecting element of the first component  300 , disengaging the inwardly deflecting element from the groove of the engagement element  410  ( FIG. 9B ). As shown in  FIG. 9B , the retention portion  417  of the disengagement element  410  causes sufficient inward deflection of the inwardly deflectable element to disengage the deflectable element form the engagement element  201 , allowing withdrawal of the second element over the first element  300 . Further advancement of the tool over the first and second components is prevented by interaction of the disengagement element  410  and the bottom flange  320  of the first component. 
         [0047]    Referring now to  FIG. 10 , a schematic top view of an embodiment of an inwardly deflectable element  310  is shown. The element  310  includes a plurality of outwardly biasing elements  315 . The biasing elements  315  may interact with an inner wall of a recess of the first component (such as inner wall  335  of recess  330  depicted in  FIG. 3 ) to outwardly bias the deflectable element  310 . The depicted deflectable element  310  includes a slit or open region  317  to facilitate insertion of the element  310  into the recess of the first component. 
         [0048]    Referring now to  FIG. 11 , a schematic perspective view of an embodiment of a first component of a multicomponent infusion device assembly is shown. The depicted first component includes an external tab  340  to serve as an alignment indicator with a corresponding external tab of a second component (e.g., as shown in  FIG. 12 ). The depicted first component also includes alignment features  350 , such as indents, to align the first component with corresponding complementary features of the second component (e.g., as shown in  FIG. 12 ). It will be understood that the first component may have any suitable number of alignment indicators or features, which each individually may be of any suitable size or shape. The depicted first component also includes a release liner  360  and adhesive (not shown) between the release liner  360  and the bottom flange of the first component. The release liner  360  may be removed to expose the adhesive so that the first component may be adhered to skin of a patient. 
         [0049]    Referring now to  FIG. 12 , a schematic perspective view showing a bottom of an embodiment of a second component  200  of a multicomponent infusion device assembly is shown. As indicated above, the second component  200  may optionally include an external alignment tab and alignment features  240 , such as detents, complementary to alignment features of the first component. It will be understood that the second component may have any suitable number of alignment indicators or features, which may each individually be of any suitable shape or size. The depicted second component includes a spring element  250  to bias the second component away from the first component. Such a spring element may facilitate disengagement of the first and second components. 
         [0050]    Referring now to  FIG. 13 , a schematic perspective view is shown of an embodiment of an assembled infusion device assembly  100  in which the first component of  FIG. 11  is secured or locked relative to the second component of  FIG. 12 . The second component includes channels  220  in the housing for receiving and guiding a disengagement element of a disengagement tool. 
         [0051]    Referring now to  FIG. 14 , a schematic perspective view of an embodiment of a disengagement tool  400  is shown. The depicted disengagement tool  400  includes disengagement elements  410  extending from a generally tubular body  420  that forms a lumen of sufficiently large inner diameter to allow the tool to be advanced over the second component of the infusion device assembly. 
         [0052]    Referring now to  FIG. 15 , a schematic perspective view is shown in which the tool  400  of  FIG. 14  is interacting with the components of the device assembly of  FIG. 13  to disengage the first component from the second component. Disengagement elements  410  of the tool  400  maintain the inwardly deflectable element  310  in an inwardly deflected orientation such that the engagement elements  210  of the second component may be released and the second component may be withdrawn from the first component as depicted. 
         [0053]    Referring now to  FIG. 16 , a schematic drawing of a top view of an embodiment of a disengagement tool  400  disposed over an embodiment of a multicomponent infusion device assembly is shown. In the top view, only the second component  200  of the infusion device assembly is visible. The top of the depicted second component includes a pump mechanism control element  270 , such as a switch, to control the rate at which a pump mechanism housed in the second component delivers therapeutic agent from a reservoir housed in the first component. The depicted second component also includes an indicator  260 , such as an LED, to alert a user of the device assembly of one or more conditions associated with the device, such as clogged or occluded flow, low reservoir, stale therapeutic agent, or any other condition for which is may be desirable to alert the user. 
         [0054]    Referring now to  FIG. 17 , a schematic drawing is shown of a perspective view of an embodiment of a disengagement tool  400  disposed over an embodiment of a multicomponent infusion device assembly. The first device assembly component includes an alignment tab  340 , and the second device assembly component includes a complementary alignment tab  230 . 
         [0055]    Referring now to  FIG. 18 , a schematic drawing is shown of a bottom view of an embodiment of a disengagement tool disposed over an embodiment of a multicomponent infusion device assembly. Disengagement elements  410  and external alignment tab  340  of the first component of the infusion device assembly are shown. 
         [0056]    While the pump-containing component is shown as being the second component in some of the figures presented herein and the reservoir-containing component is shown as being the first component in some of the figures presented herein, it will be understood that the pump-containing component may be the first component and the reservoir-containing component may be the second component. 
         [0057]    While the disengagement tool is depicted as a separate element in some of the figures presented herein, it will be understood that the disengagement component may be integrated into the second component. For example, an integrated disengagement component may be actuated by a push button mechanism (not shown) or any other suitable mechanism depending on how the disengagement component is integrated with the second component. 
         [0058]    A number of previously described wearable infusion devices or device assemblies may be modified in accordance with the teachings herein. Examples of such devices or assemblies that may be readily modified in accordance with the teachings presented herein include those shown and described in U.S. Pat. Nos. 4,562,751; 4,678,408; 4,685,903; 5,080,653; 5,097,122, and 6,551,276, which are each hereby incorporated herein by reference in their respective entireties to the extent that they do not conflict with the disclosure presented herein. 
         [0059]    Thus, embodiments of INFUSION DEVICE ASSEMBLY are disclosed. One skilled in the art will appreciate that the articles, systems and methods described herein can be practiced with embodiments other than those disclosed. The disclosed embodiments are presented for purposes of illustration and not limitation.