Low-cost ambulatory medical pump

Abstract

A low-cost medical pump for ambulatory use provides reduced life components combined with a pump lockout enforcing a safe operating limit and preventing reuse after that limit is exceeded. An improved IV line clamp portion minimizes unsupported clamp structure length and provides a dual lock system preventing inadvertent clamp release.

We claim: 
     
         1 . An ambulatory infusion pump comprising:
 a housing holding:
 (a) an IV line support structure receiving an IV line set communicating between an IV bag and a patient connection; 
 (b) a fluid pump communicating with the IV support structure to pump fluid through the IV line when the IV line is held in the IV line support structure; 
 (c) a user interface for receiving programming commands from a clinician; and 
 (d) an electronic computer communicating with the fluid pump and the user interface and executing a program stored in non-transient medium to:
 (i) monitor operation of the fluid pump to store at least one cumulative pump operation value indicating a cumulative operation of the fluid pump from a time of manufacture of the ambulatory infusion pump; 
 (ii) receive treatment protocol instructions through the user interface describing an intended future operating limit of the fluid pump to pump fluid through an IV line in a treatment protocol; 
 (iii) determine whether an amount of operation of the fluid pump necessary to implement received treatment protocol instructions will exceed a predetermined software-enforced service life of the ambulatory fluid pump reduced by the at least one cumulative pump operation value; and 
 (iv) when the amount of operation of the fluid pump necessary to implement the treatment protocol exceeds the software-enforced service life of the ambulatory fluid pump reduced by the at least one cumulative pump operation value; prevent operation of the fluid pump. 
 
   
     
     
         2 . The ambulatory infusion pump of  claim 1  further providing an indication to an individual providing the fluid pump operation instructions through the user interface that the pump has rejected the received treatment protocol instructions. 
     
     
         3 . The ambulatory infusion pump of  claim 2  wherein the indication is a visual display. 
     
     
         4 . The ambulatory infusion pump of  claim 1  wherein the software-enforced service life and the at least one cumulative pump operation value cannot be reset using the user interface. 
     
     
         5 . The ambulatory infusion pump of  claim 4  wherein the software-enforced service life and the at least one cumulative pump operation value are stored in nonvolatile memory. 
     
     
         6 . The ambulatory infusion pump of  claim 5  wherein the software-enforced service life and the at least one cumulative pump operation value cannot be altered without disassembly of the pump to access internal electronic components. 
     
     
         7 . The ambulatory infusion pump of  claim 1  wherein the software-enforced service life and the at least one cumulative pump operation value are units of volume of fluid pumped by the fluid pump. 
     
     
         8 . The ambulatory infusion pump of  claim 7  wherein the software-enforced service life is a predetermined value of less than 100 liters. 
     
     
         9 . The ambulatory infusion pump of  claim 1  wherein the software-enforced service life and the at least one cumulative pump operation value are units of time of operation of the fluid pump. 
     
     
         10 . The ambulatory infusion pump of  claim 9  wherein the software-enforced service life is less than a predetermined value of 1000 hours. 
     
     
         11 . The ambulatory infusion pump of  claim 9  wherein the software-enforced service life and cumulative pump operation value are a combination of volume of fluid pumped by the fluid pump and time of operation of the fluid pump and wherein the program step (iii) compares both a volume of fluid to be pumped by the fluid pump needed to implement the treatment protocol against a volume of fluid of the software-enforced service life, and a time of operation of the fluid pump needed to implement the treatment protocol against a time of operation of the of the software-enforced service life, each reduced by respective cumulative pump operation values; and
 (iv) when the amount of operation of the fluid pump necessary to implement the treatment protocol exceeds either of the reduced software-enforced service lives of the ambulatory fluid pump, prevent operation of the fluid pump. 
 
     
     
         12 . The ambulatory infusion pump of  claim 1  wherein the program further operates to allow entry through the user interface of a maximum flow rate for delivering medicament by control of the fluid pump according to that value. 
     
     
         13 . The ambulatory infusion pump of  claim 1  wherein the user interface consists solely of manually operated electronic switches receiving user input. 
     
     
         14 . The ambulatory infusion pump of  claim 13  wherein the computer program further executes to require entry of a password sequence through the user interface for accepting or changing treatment protocol instructions. 
     
     
         15 . The ambulatory infusion pump of  claim 14  wherein the password sequence makes use of manually operated switches labeled for other purposes. 
     
     
         16 . The ambulatory infusion pump of  claim 1  wherein the housing further holds a battery for operating all electronics of the ambulatory infusion pump. 
     
     
         17 . The ambulatory infusion pump of  claim 1  wherein the pump has a total weight less than one pound. 
     
     
         18 . The ambulatory infusion pump of  claim 1  wherein the housing provides a generally rectangular volume having an upper active portion and a lower clamp portion attachable to the upper active portion to hold the IV line therebetween extending along a longitudinal axis and wherein the upper active portion and lower clamp portion releasably attach to each other at multiple points along opposed longitudinal interfacing edges. 
     
     
         19 . The ambulatory infusion pump of  claim 1  wherein the upper active portion and lower clamp portion releasably attach along a front longitudinal edge by inter-engaging sliding hooks and tabs and wherein a front face of the housing exposes a slide operator movable in a first direction to slide the hooks and a safety stop movable against a spring in a second direction different from the first direction to a state allowing sliding of the hooks;
 whereby two distinct operations are required to release the lower clamp portion.