One piece sealing reservoir for an insulin infusion pump

Abstract

A novel one-piece fluid reservoir assembly for use in conjunction with an insulin infusion pump. The single piece fluid reservoir assembly includes a barrel body, a male luer fitting integral with the barrel body, a sealing surface integral with the barrel body, the sealing surface for sealing against the pump housing when the fluid reservoir assembly is inserted into the pump housing. Further, the barrel includes, as part of the one-piece fluid reservoir assembly, threads for engagement with threads on an opening in the fluid pump so that the fluid assembly can be inserted into the fluid pump, engage the threads and rotation therewith will locate the fluid reservoir assembly within the pump. Thereafter, a piston in the pump may be incrementally advanced to act upon a plunger in the barrel assembly to force a fluid within the barrel assembly through the male luer fitting and through a conduit engaged therewith to a remote infusion set.

1 . A fluid reservoir assembly for engaging a-pump, the pump having a housing, a reservoir chamber, a threaded, cylindrical reservoir housing chamber opening, and a piston to act on the fluid reservoir assembly when the fluid reservoir is in the reservoir chamber, the fluid reservoir assembly comprising:
 a one-piece barrel assembly, the one-piece barrel assembly including a cylindrical barrel portion having a barrel diameter and having a first open end and a second end, a male luer fitting integral with the second end of the barrel portion, the male luer fitting having an opening at a removed end thereof, the one piece barrel assembly including a neck portion integral with the barrel portion, the neck portion including threads dimensioned to engage the threads of the reservoir housing chamber opening, the one piece barrel assembly including a cylindrical sealing surface dimensioned to lay adjacent the reservoir housing chamber opening of the pump housing in fluid sealing relation, the cylindrical sealing surface integral with the neck; and   a plunger dimensioned for slideable receipt into the open end of the one-piece barrel assembly.   
     
     
         2 . An assembly for subcutaneously injecting a fluid into a person, the assembly comprising:
 a pump having a pump housing, a fluid reservoir assembly chamber, including a fluid reservoir chamber opening having threads thereon and a drive piston;   a fluid reservoir assembly including:   a one-piece barrel assembly, the one-piece barrel assembly including a cylindrical barrel portion having a barrel diameter and having a first open end and a second end, a male luer fitting integral with the second end of the barrel portion, the male luer fitting having an opening at a removed end thereof, the one piece barrel assembly including a neck portion integral with the barrel portion, the neck portion including threads dimensioned to engage the threads of the reservoir housing chamber opening, the one piece barrel assembly including a cylindrical sealing surface dimensioned to lay adjacent the reservoir housing chamber opening of the pump housing in fluid sealing relation, the cylindrical sealing surface integral with the neck; and   a plunger dimensioned for slideable receipt into the open end of the one-piece barrel assembly;   a conduit including a first end adapted to engage the male luer fitting of the fluid reservoir assembly, the conduit having a second end; and   an infusion set, for engagement with the second end of the conduit, the infusion set including a cannula capable of subcutaneous placement for feeding fluid from the reservoir, through the engaged luer fittings and the conduit into the infusion set and into the person to which the infusion set is engaged.   
     
     
         3 . The fluid reservoir assembly of  claim 1 , further comprising:
 a locking assembly for releaseably securing the cylindrical barrel portion in the housing.   
     
     
         4 . The fluid reservoir assembly of  claim 3 , wherein the locking assembly includes detents on the walls of the cylindrical sealing surface for engaging walls defining the reservoir housing chamber opening. 
     
     
         5 . The fluid reservoir assembly of  claim 1 , wherein the one-piece barrel assembly further includes tabs. 
     
     
         6 . The fluid reservoir assembly of  claim 1 , wherein the plunger includes a threaded interior portion. 
     
     
         7 . The fluid reservoir assembly of  claim 1 , wherein the plunger is adapted to receive O-rings. 
     
     
         8 . The fluid reservoir assembly of  claim 6 , further including a rod having a handle, the rod with a threaded portion, the threaded portion of the handle engageable with the threaded interior portion of the plunger. 
     
     
         9 . The fluid reservoir assembly of  claim 8 , wherein the threaded interior portion of the plunger includes a flat removed end and wherein the threaded portion of the rod includes a similarly dimensioned flat removed end adapted to be received flush against the flat removed end of the threaded interior portion of the plunger. 
     
     
         10 . The fluid reservoir assembly of  claim 1 , wherein the one-piece barrel assembly further includes walls, the walls defining a port, the port dimensioned and located on the one-piece barrel assembly such that the interior of said housing is vented when said fluid reservoir assembly is engaged therewith and said cylindrical sealing surface is laying adjacent in fluid sealing relation to the housing chamber opening in airtight engagement. 
     
     
         11 . The fluid reservoir assembly of  claim 10 , wherein the port is substantially covered with a filter medium capable of filtering water from a gas and allowing the passage of the gas therethrough. 
     
     
         12 . The fluid reservoir assembly of  claim 11 , wherein the filter medium is hydrophobic. 
     
     
         13 . (canceled) 
     
     
         14 . The fluid reservoir assembly of  claim 1 , wherein the opening of the removed end of the luer fitting is between 0.003 and 0.020 inches in diameter. 
     
     
         15 . The fluid reservoir assembly of  claim 1 , wherein the diameter of the barrel portion is less than the diameter of the threaded, cylindrical reservoir housing chamber opening. 
     
     
         16 . The fluid reservoir assembly of  claim 1 , wherein the threaded, cylindrical reservoir housing chamber includes at least one “O” ring and wherein the cylindrical sealing surface of the one-piece barrel assembly is dimensioned to contact said at least one “O” ring. 
     
     
         17 . A fluid reservoir assembly for engaging a pump, the pump having a reservoir chamber, a housing, a threaded, cylindrical reservoir housing chamber opening, and a piston to act on the fluid reservoir assembly when located in the reservoir chamber, the fluid reservoir assembly comprising:
 a barrel assembly including a cylindrical barrel portion having a first open end and a second end; and   a male luer fitting for location at the second end of the barrel portion, the male luer fitting having an opening at a removed end thereof, the opening between 0.003 and 0.20 inches in diameter.   
     
     
         18 . A fluid reservoir assembly comprising:
 a barrel portion having a first open end and a male luer fitting integral with a second open end;   a sealing surface for sealing engagement with the pump housing opening wherein the interior of the pump housing is adapted to be vented through a port integral with the sealing surface, the port having walls, the port integral with the sealing surface including outer walls, the outer walls of the port for receipt of a filtering medium thereon, the filtering medium capable of keeping water out of the interior volume of the housing.   
     
     
         19 . A fluid reservoir assembly for engaging a pump, the pump having a housing, a reservoir chamber, a threaded, cylindrical reservoir housing chamber opening, and a piston to act on the fluid reservoir assembly when the fluid reservoir is in the reservoir chamber, the fluid reservoir assembly comprising:
 a one-piece barrel assembly, the one-piece barrel assembly including:   a cylindrical barrel portion having a barrel diameter and having a first open end and a second end, a male luer fitting integral with the second end of the barrel portion, the male luer fitting having an opening at a removed end thereof, the one piece barrel assembly including:   a neck portion integral with the barrel portion, the neck portion including threads dimensioned to engage the threads of the reservoir housing chamber opening, the one piece barrel assembly including:   a cylindrical sealing surface dimensioned to lay adjacent the reservoir housing chamber opening of the pump housing in fluid sealing relation, the cylindrical sealing surface integral with the neck wherein the one-piece barrel assembly further includes tabs and further includes:   a plunger dimensioned for slideable receipt into the open end of the one-piece barrel assembly, the plunger including a threaded interior portion, the plunger adapted to receive “O” rings;   the locking assembly wherein the locking assembly includes detents on the walls of the cylindrical sealing surface for engaging walls defining the reservoir housing chamber opening;   a rod having a handle, the rod with a threaded portion, the threaded portion of the handle engageable with the threaded interior portion of the plunger;   walls defining a port, the port dimensioned and located on the one-piece barrel assembly such that the interior of said housing is vented when said fluid reservoir assembly is engaged therewith and said cylindrical sealing surface is laying adjacent in fluid sealing relation to the housing chamber opening in airtight engagement, wherein the port is substantially covered with a filter medium capable of filter water from a gas and allowing the passage of the gas therethrough, wherein the filter medium is hydrophobic, wherein the opening of the removed end of the luer fitting is between 0.003 and 0.020 inches in diameter, wherein the threaded, cylindrical reservoir housing chamber includes at least one “O” ring and wherein the cylindrical sealing surface of the one-piece barrel assembly is dimensioned to contact said at least one “O” ring.   
     
     
         20 . (canceled) 
     
     
         21 . A kit for providing insulin to a patient through an infusion set engaged with the patient, the kit comprising:
 a fluid reservoir assembly comprising a one-piece barrel assembly, the one-piece barrel assembly including a cylindrical barrel portion having a barrel diameter and having a first open end and a second end, a male luer fitting integral with the second end of the barrel portion, the male luer fitting having an opening at a removed end thereof, the one piece barrel assembly including a neck portion integral with the barrel portion, the neck portion including threads dimensioned to engage the threads of the reservoir housing chamber opening, the one piece barrel assembly including a cylindrical sealing surface dimensioned to lay adjacent the reservoir housing chamber opening of the pump housing in fluid sealing relation, the cylindrical sealing surface integral with the neck; a plunger dimensioned for slideable receipt into the open end of the one-piece barrel assembly; a rod for engaging the plunger;   a container having insulin therein, the container including a sealing septum;   a needle assembly having a female luer fitting and a needle dimensioned to puncture the sealing septum of the container; and   a pump having a reservoir chamber and a reservoir chamber opening, the reservoir chamber opening with sealing means thereon.   
     
     
         22 . An assembly for the delivery of insulin to a diabetic patient, the assembly comprising:
 a pump, the pump having a reservoir chamber, a drive piston, and a reservoir chamber opening, the reservoir chamber opening with sealing means thereon; and   a fluid reservoir comprising:   
       a one-piece barrel assembly, the one-piece barrel assembly including a cylindrical barrel portion having a barrel diameter and having a first open end and a second end, a male luer fitting integral with the second end of the barrel portion, the male luer fitting having an opening at a removed end thereof, the one piece barrel assembly including a neck portion integral with the barrel portion, the neck portion including threads dimensioned to engage the threads of the reservoir housing chamber opening, the one piece barrel assembly including a cylindrical sealing surface dimensioned to lay adjacent the reservoir housing chamber opening of the pump housing in fluid sealing relation, the cylindrical sealing surface integral with the neck. 
     
     
         23 . A fluid reservoir assembly for engaging a pump, the pump having a housing, a reservoir chamber, a threaded, cylindrical reservoir housing chamber opening having a sealing member, and a piston to act on the fluid reservoir assembly when the fluid reservoir assembly is in the reservoir chamber, the fluid reservoir assembly comprising:
 a one-piece barrel, the one-piece barrel including a cylindrical barrel portion having a barrel diameter and having a first open end and a second end, a male luer fitting integral with the second end of the barrel portion, the male luer fitting having an opening at a removed end thereof, the one piece barrel including a neck portion integral with the barrel portion, the neck portion including integral threads dimensioned to engage the threads of the reservoir housing chamber opening, the one piece barrel including a cylindrical sealing surface dimensioned to lay adjacent a reservoir housing chamber opening of the pump housing and engage the sealing member, the cylindrical sealing surface integral with the neck, the one piece barrel including a locking assembly for releaseably securing the cylindrical barrel portion in the pump housing; and   a plunger dimensioned for slideable receipt into the open end of the one-piece barrel.   
     
     
         24 . The fluid reservoir assembly of  claim 23 , wherein the locking assembly is configured to prevent the barrel from rotating due to movement between the barrel threads and the housing threads. 
     
     
         25 . The fluid reservoir assembly of  claim 24 , wherein the locking assembly includes detents on the walls of the cylindrical sealing surface for engaging walls defining the reservoir housing chamber opening. 
     
     
         26 . The fluid reservoir assembly of  claim 23 , wherein the plunger includes a threaded interior portion, and further including a rod having a handle and a threaded portion, the threaded portion of the rod engageable with the threaded interior portion of the plunger. 
     
     
         27 . The fluid reservoir assembly of  claim 26 , wherein the threads of the plunger include a flat removed end and the threads of the rod include a similarly dimensioned flat removed end adapted to be received flush against the flat removed end of the plunger threads. 
     
     
         28 . The fluid reservoir assembly of  claim 23 , wherein the one-piece barrel further includes walls, the walls defining a port, the port dimensioned and located on the one-piece barrel such that the interior of said housing is vented when said fluid reservoir assembly is engaged therewith and said cylindrical sealing surface is laying adjacent in fluid sealing relation to the housing chamber opening in airtight engagement. 
     
     
         29 . The fluid reservoir assembly of  claim 28 , wherein the port is substantially covered with a filter medium capable of filtering water from a gas and allowing the passage of the gas therethrough. 
     
     
         30 . The fluid reservoir assembly of  claim 29 , further comprising a wall extending from an external surface of the port and substantially surrounding the port, wherein the port is covered with the filter medium adjacent the external surface. 
     
     
         31 . The fluid reservoir assembly of  claim 23 , wherein the opening of the removed end of the luer fitting is between 0.003 and 0.020 inches in diameter. 
     
     
         32 . The fluid reservoir assembly of  claim 23 , wherein the diameter of the barrel portion is less than the diameter of the threaded, cylindrical reservoir housing chamber opening. 
     
     
         33 . The fluid reservoir assembly of  claim 23 , wherein the cylindrical sealing surface of the one-piece barrel is dimensioned to contact an “O” ring on the interior of the threaded, cylindrical reservoir housing chamber opening. 
     
     
         34 . A fluid reservoir assembly for engaging a pump, the pump having a housing, a reservoir chamber, a threaded, cylindrical reservoir housing chamber opening having a sealing member, and a piston to act on the fluid reservoir assembly when the fluid reservoir assembly is in the reservoir chamber, the fluid reservoir assembly comprising:
 a one-piece barrel, the one-piece barrel including a cylindrical barrel portion having a barrel diameter and having a first open end and a second end, a male luer fitting integral with the second end of the barrel portion, the male luer fitting having an opening at a removed end thereof, the one piece barrel including a neck portion integral with the barrel portion, the neck portion including integral threads dimensioned to engage the threads of the reservoir housing chamber opening, the one piece barrel including a cylindrical sealing surface dimensioned to lay adjacent a reservoir housing chamber opening of the pump housing and engage the sealing member, the cylindrical sealing surface integral with the neck, the one-piece barrel further including walls that define a port, the port dimensioned and located on the one-piece barrel such that the interior of said housing is vented when said fluid reservoir assembly is engaged therewith and said cylindrical sealing surface is laying adjacent in fluid sealing relation to the housing chamber opening; and   a plunger dimensioned for slideable receipt into the open end of the one-piece barrel.   
     
     
         35 . The fluid reservoir assembly of  claim 34 , further comprising:
 a locking assembly for releaseably securing the cylindrical barrel portion in the housing.   
     
     
         36 . The fluid reservoir assembly of  claim 35 , wherein the locking assembly is configured to prevent the barrel from rotating due to movement between the barrel threads and the housing threads. 
     
     
         37 . The fluid reservoir assembly of  claim 36 , wherein the locking assembly includes detents on the walls of the cylindrical sealing surface for engaging walls defining the reservoir housing chamber opening. 
     
     
         38 . The fluid reservoir assembly of  claim 34 , wherein the plunger includes a threaded interior portion, and further including a rod having a handle and a threaded portion, the threaded portion of the rod engageable with the threaded interior portion of the plunger. 
     
     
         39 . The fluid reservoir assembly of  claim 38 , wherein the threads of the plunger include a flat removed end and the threads of the rod include a similarly dimensioned flat removed end adapted to be received flush against the flat removed end of the plunger threads. 
     
     
         40 . The fluid reservoir assembly of  claim 34 , wherein the one-piece barrel further includes walls, the walls defining a port, the port dimensioned and located on the one-piece barrel such that the interior of said housing is vented when said fluid reservoir assembly is engaged therewith and said cylindrical sealing surface is laying adjacent in fluid sealing relation to the housing chamber opening in airtight engagement. 
     
     
         41 . The fluid reservoir assembly of  claim 40 , wherein the port is substantially covered with a filter medium capable of filtering water from a gas and allowing the passage of the gas therethrough. 
     
     
         42 . The fluid reservoir assembly of  claim 41 , further comprising a wall extending from an external surface of the port and substantially surrounding the port, wherein the port is covered with the filter medium adjacent the external surface. 
     
     
         43 . The fluid reservoir assembly of  claim 34 , wherein the opening of the removed end of the luer fitting is between 0.003 and 0.020 inches in diameter. 
     
     
         44 . The fluid reservoir assembly of  claim 34 , wherein the diameter of the barrel portion is less than the diameter of the threaded, cylindrical reservoir housing chamber opening. 
     
     
         45 . The fluid reservoir assembly of  claim 34 , wherein the cylindrical sealing surface of the one-piece barrel is dimensioned to contact an “O” ring on the interior of a threaded, cylindrical reservoir housing chamber opening. 
     
     
         46 . A fluid delivery system, the system comprising:
 a pump including a housing, a reservoir chamber, a threaded, cylindrical reservoir housing chamber opening having a sealing member, and a piston to act on the fluid reservoir assembly when the fluid reservoir assembly is in the reservoir chamber;   a one-piece barrel, the one-piece barrel including a cylindrical barrel portion having a barrel diameter and having a first open end and a second end, a male luer fitting integral with the second end of the barrel portion, the male luer fitting having an opening at a removed end thereof, the one piece barrel including a neck portion integral with the barrel portion, the neck portion including integral threads dimensioned to engage the threads of the reservoir housing chamber opening, the one piece barrel including a cylindrical sealing surface configured to lay adjacent the interior reservoir housing chamber opening of the pump housing and engaging the sealing member, the cylindrical sealing surface integral with the neck; and   a plunger dimensioned for slideable receipt into the open end of the one-piece barrel.   
     
     
         47 . The fluid delivery system of  claim 46 , wherein the cylindrical sealing surface is radially outward of the neck portion threads. 
     
     
         48 . The fluid delivery system of  claim 46 , further comprising:
 a locking assembly for releaseably securing the cylindrical barrel portion in the housing.   
     
     
         49 . The fluid delivery system of  claim 48 , wherein the locking assembly is configured to prevent the barrel from rotating due to movement between the barrel threads and the housing threads. 
     
     
         50 . The fluid delivery system of  claim 48 , wherein the locking assembly includes detents on the walls of the cylindrical sealing surface for engaging recesses in walls defining the reservoir housing chamber opening. 
     
     
         51 . The fluid delivery system of  claim 46 , wherein the plunger includes a threaded interior portion and further including a rod having a handle, the rod with a threaded portion, the threaded portion of the rod engageable with the threaded interior portion of the plunger. 
     
     
         52 . The fluid delivery system of  claim 51 , wherein the threads of the plunger include a flat removed end and the threads of the rod include a similarly dimensioned flat removed end adapted to be received flush against the flat removed end of the plunger threads. 
     
     
         53 . The fluid delivery system of  claim 46 , wherein the one-piece barrel further includes walls, the walls defining a port, the port dimensioned and located on the one-piece barrel such that the interior of said housing is vented when said fluid reservoir assembly is engaged therewith and said cylindrical sealing surface is laying adjacent in fluid sealing relation to the housing chamber opening in airtight engagement. 
     
     
         54 . The fluid delivery system of  claim 53 , wherein the port is substantially covered with a filter medium capable of filtering water from a gas and allowing the passage of the gas therethrough. 
     
     
         55 . The fluid delivery system of  claim 54 , further comprising a wall extending from an external surface of the port and substantially surrounding the port, wherein the port is covered with the filter medium adjacent the external surface. 
     
     
         56 . The fluid delivery system of  claim 46 , wherein the opening of the removed end of the luer fitting is between 0.003 and 0.020 inches in diameter. 
     
     
         57 . The fluid delivery system of  claim 46 , wherein the diameter of the barrel portion is less than the diameter of the threaded, cylindrical reservoir housing chamber opening. 
     
     
         58 . The fluid delivery system of  claim 46 , wherein the threaded, cylindrical reservoir housing chamber opening includes at least one “O” ring and wherein the cylindrical sealing surface of the one-piece barrel is dimensioned to contact said at least one “O” ring. 
     
     
         59 . The fluid reservoir assembly of  claim 3 , wherein the locking assembly is configured to prevent the barrel from rotating due to movement between the barrel threads and the housing threads.