Fluid delivery apparatus with flow indicator and vial fill

Abstract

An apparatus for accurately infusing medicinal agents into an ambulatory patient at specific rates over extended periods of time. The apparatus is of a compact, low profile, laminate construction and includes an elastic distendable membrane, chamber having a fluid outlet. Disposed within the fluid chamber is a thin fluid permeable member which precisely controls the rate of fluid flow through the fluid outlet. The apparatus also includes a highly novel fluid flow indicator that provides a readily discernible visible indication of fluid flow through the apparatus. Additionally, the apparatus includes a fill assembly comprising a prefilled vial that can be used to fill the fluid reservoir of the device with a selected medicinal fluid.

We claim:  
     
         1 . A device for use in infusing medical fluids comprising: 
 (a) a base assembly including: 
 (i) an ullage substrate having a receiving chamber formed therein; and  
 (ii) a hollow cannula mounted within said receiving chamber;  
   (b) stored energy means for forming in conjunction with said base assembly a fluid reservoir having an inlet in communication with said hollow cannula and an outlet, said energy storage means comprising at least one distendable member superimposed over said base, said member being distendable as a result of pressure imparted by the fluids to be infused, to establish internal stresses, said stresses tending to move said member toward a less distended configuration;    (c) fill means for filling said fluid reservoir, said fill means comprising a fill assembly including a container subassembly and an adapter subassembly, said container subassembly comprising: 
 (i) a fill assembly including a fluid container and an adapter subassembly, for interconnecting said fluid container with said base assembly; and  
 (ii) an auxiliary filling means including a housing connected to said ullage substrate, said housing having a fluid inlet in communication with said fluid reservoir, a fluid outlet spaced apart from said fluid inlet and valve means for controlling fluid flow between said fluid inlet and said fluid outlet;  
   (d) an outlet port in communication with said outlet of said reservoir for dispensing fluids from the device; and    (e) fluid actuated indicator means disposed intermediate said fluid outlet of said reservoir and said outlet port for visually indicating fluid flow from said fluid reservoir.    
     
     
         2 . A device as defined in    claim 1    in which said fluid container of said fill assembly has first and second open ends and in which said fill assembly further includes: 
 (a) pierceable means for sealably closing one of said first and second open ends of said container, said pierceable means being pierceable by said hollow cannula; and  
 (b) a plunger telescopically movable within said container from a first location proximate said pierceable means to a second, spaced-apart location.  
 
     
     
         3 . A device as defined in    claim 1    in which said indicator means comprises first and second at least partially overlaying thin films, said film being movable relative to each other in response to fluid flowing from said fluid reservoir.  
     
     
         4 . A device as defined in    claim 1    further including flow control means disposed intermediate said indicator means and said outlet of said fluid reservoir for controlling the rate of flow of fluid from the device.  
     
     
         5 . A device for use in infusing medicinal fluid into a patient at a controlled rate comprising: 
 (a) a base having a receiving chamber formed therein;    (b) a hollow blunt end cannula mounted within said receiving chamber of said base;    (c) stored energy means for forming, in conjunction with said base a fluid reservoir having an inlet in communication with said hollow cannula and an outlet, said energy storage means comprising at least one distendable member superimposed over said base, said member being distendable as a result of pressure imparted by the fluids to be infused, to establish internal stresses, said stresses tending to move said member toward a less distended configuration;    (d) container means interconnectable with said base for filling said fluid reservoir said container means comprising: 
 (i) a container having a fluid chamber with first and second open ends;  
 (ii) a plunger telescopically movable within said container from a first location proximate said pierceable means to a second, spaced-apart location;  
   (e) adapter means for interconnecting said container means with said base, said adapter means comprising: 
 (i) first hollow housing for receiving said container of said container means, said first hollow housing having: 
 a. first and second open ends;  
 b. an intermediate wall disposed between said first and second open ends;  
 c. a sharp, needle-like hollow cannula connected to and extending through said intermediate wall for piercing engagement with said pierceable means of said container assembly; and  
 d. a split cannula sealably closing said first end of said first hollow housing;  
 
 (ii) a second hollow housing for receiving said first hollow housing, said second hollow housing being receivable within said receiving chamber of said base to move said split cannula of said first hollow housing into engagement with said blunt end cannula; and  
   (e) fluid dispensing means in communication with said outlet of said fluid reservoir for dispensing fluids from the device.    
     
     
         6 . A device as defined in    claim 5    further including fluid actuator means disposed intermediate said fluid outlet of said reservoir and said fluid dispensing means for visually indicating fluid flow from said fluid reservoir.  
     
     
         7 . A device as defined in    claim 6    further including flow control means disposed intermediate said indicator means and said outlet of said fluid reservoir for controlling the rate of flow of fluid from the device.  
     
     
         8 . A device as defined in    claim 7    in which said indicator means comprises first and second at least partially overlaying thin films, said films being movable relative to each other in response to fluid flowing from said fluid reservoir.  
     
     
         9 . A device for use in infusing medical fluids comprising: 
 (a) a base assembly including: 
 (i) an ullage substrate having a receiving chamber formed therein; and  
 (ii) a hollow cannula mounted within said receiving chamber;  
 (iii) a plurality of generally ring shaped guides mounted within said receiving chamber;  
   (b) stored energy means for forming in conjunction with said base assembly a fluid reservoir having an inlet in communication with said hollow cannula and an outlet, said energy storage means comprising at least one distendable member superimposed over said base, said member being distendable as a result of pressure imparted by the fluids to be infused, to establish internal stresses, said stresses tending to move said member toward a less distended configuration; and    (c) fill means receivable within said receiving chamber of said base for filling said fluid reservoir, said fill means comprising a fill assembly including a container and an adapter subassembly, said container being telescopically movable within said receiving chamber from a first position to a second position, said container also receivable within and guided by said ring shaped guides as said container moves from said first location to said second location.    
     
     
         10 . A device as defined in    claim 9    in which said adapter subassembly comprises a hollow housing having an elongated generally cylindrical wall.  
     
     
         11 . A device as defined in    claim 10    in which said ullage substrate is provided with an elongated bore having a longitudinally extending surface and in which said receiving chamber of said ullage substrate is defined by an elongated, generally cylindrically shaped inner wall, said inner wall defining in conjunction with said surface of said bore, an annular space, said wall of said hollow housing of said adapter subassembly being telescopically receivable within said annular space.  
     
     
         12 . A device as defined in    claim 11    further including fluid actuated indicator means for visually indicating fluid flow from said fluid outlet of said reservoir.  
     
     
         13 . A device as defined in    claim 12    further including flow control means disposed intermediate said indicator means and said outlet of said fluid reservoir for controlling the rate of flow of fluid from the device.  
     
     
         14 . A device as defined in    claim 13    in which said indicator means comprises first and second at least partially overlaying thin films, said films being movable relative to each other in response to fluid flowing from said fluid reservoir.  
     
     
         15 . A device for use in infusing medicinal fluid into a patient at a controlled rate comprising: 
 (a) a reservoir assembly including a base having a receiving chamber formed therein;    (b) stored energy means for forming, in conjunction with said base a fluid reservoir having an inlet and an outlet in said stored energy means comprising at least one distendable member superimposed over said base, said member being distendable as a result of pressure imparted by the fluids to be infused, to establish internal stresses, said stresses tending to move said member toward a less distended configuration;    (c) fluid delivery means in communication with said outlet of said fluid reservoir for delivery fluid from the device;    (d) flow control means disposed intermediate said outlet of said fluid reservoir and said fluid delivery means for controlling the rate of flow of fluid flowing from said fluid delivery means;    (e) closure means connected to said reservoir assembly for supporting therewithin said fluid delivery means; and    (f) fill means receivable within said receiving chamber for filling said fluid reservoir, said fill means comprising a container subassembly, said container assembly comprising: 
 (i) a container having a fluid chamber with first and second open ends;  
 (ii) pierceable means for sealably closing one of said first and second open ends of said container; and  
 (iii) a plunger telescopically movable within said container from a first location proximate said pierceable means to a second, spaced-apart location.  
   
     
     
         16 . A device as defined in    claim 15    in which said fill means further comprises an adapter subassembly, said adapter subassembly including a hollow housing for receiving said container, said hollow housing having first and second ends.