LOW-COST AMBULATORY MEDICAL PUMP
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.
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.