US20160058940A1 - Low-cost ambulatory medical pump - Google Patents
Low-cost ambulatory medical pump Download PDFInfo
- Publication number
- US20160058940A1 US20160058940A1 US14/471,102 US201414471102A US2016058940A1 US 20160058940 A1 US20160058940 A1 US 20160058940A1 US 201414471102 A US201414471102 A US 201414471102A US 2016058940 A1 US2016058940 A1 US 2016058940A1
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- United States
- Prior art keywords
- pump
- fluid
- ambulatory infusion
- software
- infusion pump
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/22—Valves or arrangement of valves
- A61M39/28—Clamping means for squeezing flexible tubes, e.g. roller clamps
- A61M39/284—Lever clamps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/1413—Modular systems comprising interconnecting elements
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/14212—Pumping with an aspiration and an expulsion action
- A61M5/14228—Pumping with an aspiration and an expulsion action with linear peristaltic action, i.e. comprising at least three pressurising members or a helical member
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
- F04B—POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS
- F04B43/00—Machines, pumps, or pumping installations having flexible working members
- F04B43/0009—Special features
- F04B43/0054—Special features particularities of the flexible members
- F04B43/0072—Special features particularities of the flexible members of tubular flexible members
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
- F04B—POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS
- F04B43/00—Machines, pumps, or pumping installations having flexible working members
- F04B43/08—Machines, pumps, or pumping installations having flexible working members having tubular flexible members
- F04B43/082—Machines, pumps, or pumping installations having flexible working members having tubular flexible members the tubular flexible member being pressed against a wall by a number of elements, each having an alternating movement in a direction perpendicular to the axes of the tubular member and each having its own driving mechanism
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
- F04B—POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS
- F04B43/00—Machines, pumps, or pumping installations having flexible working members
- F04B43/12—Machines, pumps, or pumping installations having flexible working members having peristaltic action
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M2005/14288—Infusion or injection simulation
- A61M2005/14292—Computer-based infusion planning or simulation of spatio-temporal infusate distribution
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/50—General characteristics of the apparatus with microprocessors or computers
- A61M2205/502—User interfaces, e.g. screens or keyboards
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/50—General characteristics of the apparatus with microprocessors or computers
- A61M2205/502—User interfaces, e.g. screens or keyboards
- A61M2205/505—Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/50—General characteristics of the apparatus with microprocessors or computers
- A61M2205/502—User interfaces, e.g. screens or keyboards
- A61M2205/507—Head Mounted Displays [HMD]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/50—General characteristics of the apparatus with microprocessors or computers
- A61M2205/52—General characteristics of the apparatus with microprocessors or computers with memories providing a history of measured variating parameters of apparatus or patient
Definitions
- the present invention relates to compact infusion pumps for ambulatory use and in particular to an infusion pump design to reduce the costs of medical care delivery.
- Medical pumps such as infusion pumps, are known for computer-controlled delivery of medication (henceforth medicaments) to patients over a period of time.
- medication forth medicaments
- battery-powered compact infusion pumps have become available that permit the patient to remain active (ambulatory), for example, in a home environment away from a clinic or hospital during the treatment.
- the medicament is provided in a flexible bag that may be connected to an IV line which in turn attaches to a needle or port communicating with the patient.
- a nurse or other healthcare professional ministering to the patient receives the medicament, reviews the medicament description for correctness, and enters the desired dose and rate into the pump.
- the IV line is then installed in the portable pump and the assembly placed in a pack or other carrying apparatus that may be retained on the patient.
- the medicament may be delivered as the patient proceeds through normal life activities until the full dose is complete.
- the patient may then return the assembly to the nurse or health care professional who may provide a new bag of medicament and IV line, and may reprogram the pump for new treatment.
- Pumps suitable for ambulatory use can have high total operating costs driven in part by the cost of the pump itself which must meet exacting medical standards while being compact, lightweight, and ruggedized for portable use.
- the present inventors have determined further that the recovery rate of ambulatory pumps is historically low. Failure to recover the pump can occur when pumps are used in end-of-life treatment, or are damaged or lost in the field.
- the present invention provides a cost-reduced ambulatory pump intended to increase availability and acceptability of ambulatory infusion.
- Lower cost is obtained by designing the pump with a component's short operating life specification, recognizing that the field operating life of such pumps is relatively short as biased by low pump recovery rates.
- Safety is ensured by incorporating absolute operating life limits into the pump that prevent the pump from being used in excess of its design life. In particular, maximum pump volume and maximum operating time may be monitored and used to block further use of the pump if that use would exceed safe operating limits.
- the pump also provides an improved IV line clamp system reducing the material costs of a significant mechanical component of the pump.
- the invention provides an ambulatory infusion pump having a housing that holds an IV line support structure receiving an IV line set and a fluid pump communicating with the IV support structure to pump fluid through an IV line.
- the housing also includes an electronic computer commuting with the fluid pump and with a user interface for receiving programming commands from a clinician.
- the electronic computer monitors 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.
- the computer determines whether an amount of operation of the fluid pump necessary to implement received treatment protocol instructions will exceed the software-enforced service life of the ambulatory fluid pump reduced by at least one cumulative pump operation value, and if so, prevents further operation of the fluid pump.
- the computer may further provide 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.
- the software-enforced service life and at least one cumulative pump operation value cannot be reset using the user interface.
- the indication may be a visual display
- the software-enforced service life and at least one cumulative pump operation value may be stored in nonvolatile memory.
- the software-enforced service life and at least one cumulative pump operation value are stored so that they cannot be altered without disassembly of the pump to access internal electronic components.
- the software-enforced service life and at least one cumulative pump operation value may be in units of volume of fluid pumped by the fluid pump.
- the software-enforced service life may be less than 100 liters.
- the software-enforced service life and at least one cumulative pump operation value may be units of time of operation of the fluid pump.
- the software-enforced service life may be less than 1000 hours.
- the software-enforced service life and at least one cumulative pump operation value may be a combination of volume of fluid pumped by the fluid pump and time of operation of the fluid pump, and the program may compare both a volume of fluid to be pumped by the fluid pump against a volume of fluid of the software-enforced service life and compare a time of operation of the fluid pump against a time of operation of the ambulatory fluid pump, each service life reduced by respective cumulative pump operation values.
- the amount of operation of the fluid pump necessary to implement the treatment protocol exceeds either adjusted software-enforced service lives, operation of the fluid pump is prevented.
- the program may further operate to allow entry through the user interface of a maximum flow rate for delivering medicament.
- the user interface may consist solely of manually operated electronic switches for the purpose of receiving user input.
- the computer program may further execute to require entry of a password sequence through the user interface for accepting or changing treatment protocol instructions.
- the password sequence may make use of manually operated switches labeled for other purposes.
- the housing may provide a generally rectangular volume having a 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 the upper active portion and lower clamp portion may releasably attach to each other at multiple points along opposed longitudinal interfacing edges.
- the upper active portion and lower clamp portion may releasably attach along a front longitudinal edge by inter-engaging sliding hooks and tabs 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.
- FIG. 1 is a simplified perspective view of the ambulatory pump assembly as provided to a patient;
- FIG. 2 is a front elevational view of the ambulatory pump showing inter-assembly of an upper active portion and lower clamp portion of the housing as separated by operation of dual release elements and showing a user interface comprising a display and manually operated buttons;
- FIG. 3 is a simplified block diagram of the electronics of the pump of FIGS. 1 and 2 as controlled by internal electronic computer executing a stored program;
- FIG. 4 is a flowchart of the stored program of FIG. 3 and the data structures used by that program;
- FIG. 5 is a first fragmentary cross-sectional view taken along 5 - 5 of FIG. 1 and a second perpendicular cross-section aligned therewith showing operation of the dual release elements of FIG. 2 ;
- FIG. 6 is a perspective fragmentary view of the upper active portion and lower clamp portion as released showing various elements thereof.
- an ambulatory pump 10 may operate in conjunction with a medicament bag 12 communicating with an IV line 14 .
- the medicament bag 12 may be, for example, a flexible plastic bag of the type used to hold IV solutions, and the IV line 14 provides a flexible tube allowing the flow of medicament from the medicament bag 12 and a patient connector 16 that may communicate with the patient through a needle or port or the like.
- the IV line 14 may include a bubble filter 17 for removing included air bubbles, limiting the need for air bubble sensing.
- the ambulatory pump 10 provides a two-part housing having an upper electronics portion 18 that may attach to a lower clamp portion 20 to receive the IV line 14 therebetween along a longitudinal axis 22 being generally the longest dimension of the housing of the ambulatory pump 10 . As so received, the ambulatory pump 10 may pump liquid through the IV line 14 by peristaltic action.
- the ambulatory pump 10 is constructed to weigh less than a half pound and preferably less than 1.5′′ ⁇ 2′′ ⁇ 5′′ so as to be easily carried by the patient, for example, in a pouch 24 also sized to receive the medicament bag 12 .
- the housing of the upper active portion may present on its front surface a user interface 26 comprising, for example, a liquid crystal type display 28 for displaying symbols and alphanumeric characters under computer control.
- the user interface 26 also provides multiple membrane switch pushbuttons 30 that may be activated by a user.
- the pushbuttons include a limited number of controls including, in one embodiment, run and stop pushbuttons 30 a and 30 b , respectively, that will stop and start operation of the pump as will be described below; a rate pushbutton 30 c allows setting of the maximum pumping rate of the ambulatory pump 10 in milliliters per hour by cycling through menu standard rates with each push (?).
- the pushbuttons also include a “volume to be infused” pushbutton 30 d allowing user control of the maximum volume to be infused during a treatment protocol, also by cycling through standard settings with each push, as well as an information pushbutton 30 allowing the display of detailed information about the pump including remaining pump life (?).
- Pushbutton 30 f allows the unit to be turned on and off to conserve power.
- a bolus pushbutton 30 allows short operation of the pump to deliver medicament in fixed patient controlled bolus quantities (?).
- a lower edge of the upper electronics portion 18 provides for a clamp release slide 32 as will be described below and safety lock 34 that must be simultaneously activated to remove the lower clamp portion 20 .
- the ambulatory pump 10 may include a microcontroller 36 being an electronic computer having a self-contained nonvolatile memory 38 holding an operating program 40 and necessary storage variables as will be described below.
- the nonvolatile memory may comprise, for example, flash memory and/or read only memory, or other similar nonvolatile memory as context requires, which may store data values to be retained even in the absence of electrical power.
- the microcontroller 36 also provides various inputs and output lines communicating, for example, with the display 28 for providing display information thereon and various pushbuttons 30 for receiving data related to their activation by user.
- the microcontroller 36 may provide control lines to the pump assembly 42 having, for example, an internal DC electric motor (not shown) operating through a gear system to activate peristaltic plunger elements 44 that may press against the contained IV line 14 to push fluid therethrough.
- the peristaltic plunger elements 44 extend in an undulating serpentine fashion to compress and release the tubing thereby moving fluid therethrough.
- the microcontroller 36 may also communicate electrically with various sensors.
- upstream and downstream pressure sensors 46 and 48 which can be used to ensure proper operation of the pump by detecting abnormal pressures.
- each of the pressure sensors 46 and 48 may provide a spring-loaded plunger that presses into the outer wall of the IV line 14 to sense pressure.
- This through-wall measurement avoids the need for separate connections to the fluid-contacting pressure sensor and the problems of sterilization of a fluid-contacting pressure sensor.
- the spring-loaded plunger deforms a portion of a wall of the IV line 14 as held against a backstop. Under a known spring biasing force, the amount of deflection of the wall may be measured to deduce internal pressure.
- the system may be calibrated for a particular material of the IV line 14 .
- All electrical components in the upper electronics portion 18 maybe supplied with power by a contained storage battery 49 that may provide its power directly or through standard power processing circuits such as regulators and the like.
- a clinician will enter a total volume to be infused 52 and an infusion rate 54 , as shown by process block 50 , by using the user interface 26 shown in FIG. 2 .
- a password which must be entered first, indicated by process block 56 .
- the password may employ a predetermined sequence of pressing of the pushbuttons 30 (for example, after the unit is turned on but before it is programmed) such as pressing the run pushbutton 30 a once and the stop pushbutton 30 b twice.
- Such use of the pushbuttons 30 may be without regard to the actual labels of the button as, in this example, “run” and “stop”.
- the total volume to be infused 52 and the infusion rate 54 are then used to compute a total infusion time 58 that may, but need not be, a continuous time period but which may also be a cumulative time necessary for the infusion, contemplating that the infusion may be started and stopped by the patient.
- the total volume to be infused 52 and the infusion time 58 represent received protocol instructions (either direct or indirect) from a clinician describing the intended operating limits of the fluid pump in a treatment protocol.
- the total volume to be infused 52 is compared against a preset software-enforced volume limit 62 of the pump 10 after the software-enforced volume limit 62 is reduced by the cumulative pumped volume 66 .
- the cumulative pumped volume 66 is set to zero when the ambulatory pump 10 is manufactured and then increases with operation of the pump assembly 42 .
- the total infusion time 58 is compared against a preset software-enforced time limit 64 as reduced by the cumulative pump operation time 68 .
- the cumulative pump operation time is also set to zero when the ambulatory pump 10 is manufactured and then increases with operation of the ambulatory pump 10 determined from activation of the on pushbutton 30 f not necessarily including activation of the pump assembly 42 .
- the net effect of process block 60 is to see if the intended treatment protocol can be performed before the service life of the pump has been exceeded.
- the program 40 proceeds to process block 72 and provides a warning that the treatment protocol may not be implemented as displayed on the display 28 of FIG. 2 .
- the program 40 then returns the process block 50 without operation of the pump assembly 42 and a new password and new values must be entered if operation is to be continued.
- Decision block 70 may also check for adequate remaining battery energy for the protocol using an internal time-to-ampere-hour conversions based on the current drain of the ambulatory pump and comparing that against the estimated total ampere-hours of the battery.
- the program proceeds to decision block 74 and may begin operation as indicated by process block 76 , when the run pushbuttons 30 a is pressed. The program loops until the run pushbutton 30 a is pressed or the unit is switched off.
- the values 66 , 68 , 62 , and 64 contained in memory 38 may not be changed and the program 40 does not allow these values to be changed by the operator through the user interface 26 . More generally, these values may not be changed by removing power from the ambulatory pump 10 (e.g. removing battery 49 shown in FIG. 3 ) and generally require disassembly of the pump 10 to obtain direct access to the pin structure of the microcontroller 36 and specialized equipment to access the memory directly if that is even possible. It is contemplated that these values may be stored in a way that cannot be changed without destruction of the ambulatory pump 10 or microcontroller 36 .
- the operation of the pump at process block 76 will normally monitor the pressure sensors 48 and 46 to ensure there is no upstream or downstream occlusion of medicament flow. Any such obstruction will cause a ceasing of the operation of the pump assembly 42 which may be reactivated after correction by the user.
- pump flow-rate is controlled by controlling the speed of the pump assembly 42 in open loop fashion according to the entered infusion rate 54 .
- the pump's 76 accumulated time and pumping volume per process block 77 are used to update cumulative pumped volume 66 and cumulative pump operation time 68 .
- decision block 78 may be polled to see if the stop pushbutton 30 b has been pressed in which case the pump assembly 42 stops and the program 40 returns to decision block 74 .
- decision block 80 determines whether the total volume through the ambulatory pump 10 during this treatment protocol has reached the total volume to be infused 52 . If so, the program 40 loops back to process block 50 , but if not the program returns to process block 76 .
- the upper surface of the lower clamp portion 20 may provide for a shallow tray having upstanding peripheral longitudinally-opposed end walls 90 and 92 , these walls separating the opposed upstanding peripheral longitudinally-extending sidewalls 94 and 96 .
- the end walls 90 may include notches receiving retention bushings 98 a and 98 formed in the IV line 14 to prevent longitudinal movement of the IV line 14 with respect to the lower clamp portion 20 along the longitudinal axis 22 .
- the material of the IV line 14 may be replaced with a silicon material that is softer and more conducive to peristaltic pumping and through-wall pressure sensing.
- the portion of the IV line 14 within the tray of the lower clamp portion 20 may be held by guides 100 which form notches to align and retain the IV line 14 with the peristaltic plunger elements 44 and the downwardly extending operators of the pressure sensors 46 and 48 held in the bottom wall 101 of upper electronics portion 18 .
- the guides 100 may also provide for backstops holding the IV line 14 against the pressure of the downwardly extending operators of the pressure sensors 46 and 48 and the peristaltic plunger elements 44 .
- the IV line 14 may pass through a spring bias clamp element 102 that automatically clamps the IV line 14 when the lower clamp portion 20 is separated from the upper electronics portion 18 .
- Rear sidewall 96 includes upwardly extending open hinge collars 104 spaced along its edge that may attached to and hinge about hinge pin 106 supported at a rear edge of the bottom wall 101 of the upper electronics portion 18 , spaced below the bottom wall 101 and generally parallel to the longitudinal axis 22 .
- Front sidewall 94 includes longitudinally-extending tabs 107 that may be engaged by corresponding hooks 108 extending down from the front edge of the bottom wall 101 of the upper electronics portion 18 and activated by release slide 32 as will be described to move generally along the longitudinal axis 22 .
- the hooks 108 may pass over and attach to the tabs 107 to retain the upper electronics portion 18 and lower clamp portion 20 together with the IV line 14 in proper alignment and clamp therebetween.
- the downwardly extending hooks 108 may be attached to a common driver bar 110 that is longitudinally spring biased by a spring 112 into engagement with the tabs 107 tending to hold the lower clamp portion 20 against the upper electronics portion 18 .
- the bar 110 may communicate with release slide 32 which may be pressed rightward against the biasing spring 112 to allow release of the hooks 108 from the tabs 107 .
- references to “a microprocessor” and “a processor” or “the microprocessor” and “the processor,” can be understood to include one or more microprocessors or other types of computers, gate arrays or the like that can execute programs and communicate with each other.
- references to memory can include one or more processor-readable and accessible memory elements and/or components that can be internal to the processor-controlled device, external to the processor-controlled device, and can be accessed via a wired or wireless network.
- the term manual pushbuttons means buttons that may be operated by finger touch or the like including touchscreen and passive switch and mechanical switch.
- the look-ahead operation of the ambulatory pump 10 described herein is consistent both with anticipatory locking of the pump so that the pump does not exceed the service values, as well as setting the service values to a value below the actual longest desired service value by amount of the typical treatment protocol and allowing the treatment protocol to exceed the service value once, and then locking out pump.
- the pump lockout anticipates that the next treatment protocol would exceed the remaining operating time or volume (which is a negative value) and need not actually accept a new protocol.
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.
Description
- The present invention relates to compact infusion pumps for ambulatory use and in particular to an infusion pump design to reduce the costs of medical care delivery.
- Medical pumps, such as infusion pumps, are known for computer-controlled delivery of medication (henceforth medicaments) to patients over a period of time. Recently, battery-powered compact infusion pumps have become available that permit the patient to remain active (ambulatory), for example, in a home environment away from a clinic or hospital during the treatment.
- Typically the medicament is provided in a flexible bag that may be connected to an IV line which in turn attaches to a needle or port communicating with the patient. A nurse or other healthcare professional ministering to the patient receives the medicament, reviews the medicament description for correctness, and enters the desired dose and rate into the pump. The IV line is then installed in the portable pump and the assembly placed in a pack or other carrying apparatus that may be retained on the patient. The medicament may be delivered as the patient proceeds through normal life activities until the full dose is complete. The patient may then return the assembly to the nurse or health care professional who may provide a new bag of medicament and IV line, and may reprogram the pump for new treatment.
- Pumps suitable for ambulatory use can have high total operating costs driven in part by the cost of the pump itself which must meet exacting medical standards while being compact, lightweight, and ruggedized for portable use. The present inventors have determined further that the recovery rate of ambulatory pumps is historically low. Failure to recover the pump can occur when pumps are used in end-of-life treatment, or are damaged or lost in the field.
- High operating costs associated with ambulatory pumps necessarily limit the availability of the use of such medical devices to some individuals even though the pump could greatly improve the quality of care.
- The present invention provides a cost-reduced ambulatory pump intended to increase availability and acceptability of ambulatory infusion. Lower cost is obtained by designing the pump with a component's short operating life specification, recognizing that the field operating life of such pumps is relatively short as biased by low pump recovery rates. Safety is ensured by incorporating absolute operating life limits into the pump that prevent the pump from being used in excess of its design life. In particular, maximum pump volume and maximum operating time may be monitored and used to block further use of the pump if that use would exceed safe operating limits. The pump also provides an improved IV line clamp system reducing the material costs of a significant mechanical component of the pump.
- Specifically, the invention provides an ambulatory infusion pump having a housing that holds an IV line support structure receiving an IV line set and a fluid pump communicating with the IV support structure to pump fluid through an IV line. The housing also includes an electronic computer commuting with the fluid pump and with a user interface for receiving programming commands from a clinician. During operation, the electronic computer monitors 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. The computer determines whether an amount of operation of the fluid pump necessary to implement received treatment protocol instructions will exceed the software-enforced service life of the ambulatory fluid pump reduced by at least one cumulative pump operation value, and if so, prevents further operation of the fluid pump.
- It is thus a feature of at least one object of the invention to provide look-ahead lockout of the programming of the pump, and when such programming is for a treatment protocol that would exceed the design pump operating life value, such design pump operating life is set to allow the safe use of durability components.
- The computer may further provide 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.
- It is thus a feature of at least one embodiment of the invention to clearly indicate the occurrence of the lockout, for example, so that it is not interpreted as the need for service, increasing pump-associated costs.
- The software-enforced service life and at least one cumulative pump operation value cannot be reset using the user interface.
- It is thus a feature of at least one embodiment of the invention to prevent unauthorized recycling of unsafe pumps or unsafe modification of the pump.
- The indication may be a visual display
- It is thus a feature of at least one embodiment of the invention to make use of a pre-existing user program element to provide an indication of pump lockout.
- The software-enforced service life and at least one cumulative pump operation value may be stored in nonvolatile memory.
- It is thus a feature of at least one embodiment of the invention to reduce the chance of inadvertent or intentional resetting of the service limits by removing power from the pump.
- The software-enforced service life and at least one cumulative pump operation value are stored so that they cannot be altered without disassembly of the pump to access internal electronic components.
- It is thus a feature of at least one embodiment of the invention to provide hardware barriers to reuse of the pump beyond its safe service life.
- The software-enforced service life and at least one cumulative pump operation value may be in units of volume of fluid pumped by the fluid pump.
- It is thus a feature of at least one embodiment of the invention to provide a measure of pump operation which reveals wear of the critical pump element.
- The software-enforced service life may be less than 100 liters.
- It is thus a feature of at least one embodiment of the invention to limit pump operation to permit the use of lower-cost pump elements subject to more rapid wear, for example, employing lower-cost motors, simpler bearings and less expensive material subject to wear.
- Alternatively or in addition, the software-enforced service life and at least one cumulative pump operation value may be units of time of operation of the fluid pump.
- It is thus a feature of at least one embodiment of the invention to provide a measurement of pump field life that reveals exposure of the pump to environmental contaminants and the aging of pump components regardless of wear.
- The software-enforced service life may be less than 1000 hours.
- It is thus a feature of at least one embodiment of the invention to limit pump operation to accommodate pump element contamination and material aging.
- The software-enforced service life and at least one cumulative pump operation value may be a combination of volume of fluid pumped by the fluid pump and time of operation of the fluid pump, and the program may compare both a volume of fluid to be pumped by the fluid pump against a volume of fluid of the software-enforced service life and compare a time of operation of the fluid pump against a time of operation of the ambulatory fluid pump, each service life reduced by respective cumulative pump operation values. When the amount of operation of the fluid pump necessary to implement the treatment protocol exceeds either adjusted software-enforced service lives, operation of the fluid pump is prevented.
- It is thus a feature of at least one embodiment of the invention to combine two measures of service life together to provide a more robust definition of the life of the pump.
- The program may further operate to allow entry through the user interface of a maximum flow rate for delivering medicament.
- It is thus a feature of at least one embodiment of the invention to permit other safeguards to be determined by the clinician programming the pump.
- The user interface may consist solely of manually operated electronic switches for the purpose of receiving user input.
- It is thus a feature of at least one embodiment of the invention to provide a cost-reduced control commensurate with the desired low-cost design of the pump.
- The computer program may further execute to require entry of a password sequence through the user interface for accepting or changing treatment protocol instructions.
- It is thus a feature of at least one embodiment of the invention to provide pump programming consistent with use in an unsupervised setting.
- The password sequence may make use of manually operated switches labeled for other purposes.
- It is thus a feature of at least one embodiment of the invention to provide for password-secured settings without the need for additional password input capabilities.
- In some embodiments, the housing may provide a generally rectangular volume having a 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 the upper active portion and lower clamp portion may releasably attach to each other at multiple points along opposed longitudinal interfacing edges.
- It is thus a feature of at least one embodiment of the invention to provide a more robust IV line clamping system by minimizing the unsupported span of the clamp portion.
- The upper active portion and lower clamp portion may releasably attach along a front longitudinal edge by inter-engaging sliding hooks and tabs 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.
- It is thus a feature of at least one embodiment of the invention to better prevent accidental disengagement of the clamp portion and IV line during ambulatory use.
- These particular objects and advantages may apply to only some embodiments falling within the claims and thus do not define the scope of the invention.
-
FIG. 1 is a simplified perspective view of the ambulatory pump assembly as provided to a patient; -
FIG. 2 is a front elevational view of the ambulatory pump showing inter-assembly of an upper active portion and lower clamp portion of the housing as separated by operation of dual release elements and showing a user interface comprising a display and manually operated buttons; -
FIG. 3 is a simplified block diagram of the electronics of the pump ofFIGS. 1 and 2 as controlled by internal electronic computer executing a stored program; -
FIG. 4 is a flowchart of the stored program ofFIG. 3 and the data structures used by that program; -
FIG. 5 is a first fragmentary cross-sectional view taken along 5-5 ofFIG. 1 and a second perpendicular cross-section aligned therewith showing operation of the dual release elements ofFIG. 2 ; and -
FIG. 6 is a perspective fragmentary view of the upper active portion and lower clamp portion as released showing various elements thereof. - Referring now to
FIG. 1 , anambulatory pump 10 may operate in conjunction with amedicament bag 12 communicating with anIV line 14. Themedicament bag 12 may be, for example, a flexible plastic bag of the type used to hold IV solutions, and theIV line 14 provides a flexible tube allowing the flow of medicament from themedicament bag 12 and apatient connector 16 that may communicate with the patient through a needle or port or the like. TheIV line 14 may include abubble filter 17 for removing included air bubbles, limiting the need for air bubble sensing. - The
ambulatory pump 10 provides a two-part housing having anupper electronics portion 18 that may attach to alower clamp portion 20 to receive theIV line 14 therebetween along alongitudinal axis 22 being generally the longest dimension of the housing of theambulatory pump 10. As so received, theambulatory pump 10 may pump liquid through theIV line 14 by peristaltic action. - In one embodiment, the
ambulatory pump 10 is constructed to weigh less than a half pound and preferably less than 1.5″×2″×5″ so as to be easily carried by the patient, for example, in apouch 24 also sized to receive themedicament bag 12. - Referring now to
FIG. 2 , the housing of the upper active portion may present on its front surface auser interface 26 comprising, for example, a liquidcrystal type display 28 for displaying symbols and alphanumeric characters under computer control. Theuser interface 26 also provides multiplemembrane switch pushbuttons 30 that may be activated by a user. Generally, the pushbuttons include a limited number of controls including, in one embodiment, run and stoppushbuttons rate pushbutton 30 c allows setting of the maximum pumping rate of theambulatory pump 10 in milliliters per hour by cycling through menu standard rates with each push (?). The pushbuttons also include a “volume to be infused”pushbutton 30 d allowing user control of the maximum volume to be infused during a treatment protocol, also by cycling through standard settings with each push, as well as aninformation pushbutton 30 allowing the display of detailed information about the pump including remaining pump life (?).Pushbutton 30 f allows the unit to be turned on and off to conserve power. Abolus pushbutton 30 allows short operation of the pump to deliver medicament in fixed patient controlled bolus quantities (?). - A lower edge of the
upper electronics portion 18 provides for aclamp release slide 32 as will be described below andsafety lock 34 that must be simultaneously activated to remove thelower clamp portion 20. - Referring now to
FIG. 3 , theambulatory pump 10 may include amicrocontroller 36 being an electronic computer having a self-containednonvolatile memory 38 holding anoperating program 40 and necessary storage variables as will be described below. The nonvolatile memory may comprise, for example, flash memory and/or read only memory, or other similar nonvolatile memory as context requires, which may store data values to be retained even in the absence of electrical power. - The
microcontroller 36 also provides various inputs and output lines communicating, for example, with thedisplay 28 for providing display information thereon andvarious pushbuttons 30 for receiving data related to their activation by user. In addition, themicrocontroller 36 may provide control lines to thepump assembly 42 having, for example, an internal DC electric motor (not shown) operating through a gear system to activateperistaltic plunger elements 44 that may press against the containedIV line 14 to push fluid therethrough. As is understood in the art, generally theperistaltic plunger elements 44 extend in an undulating serpentine fashion to compress and release the tubing thereby moving fluid therethrough. - The
microcontroller 36 may also communicate electrically with various sensors. For example, upstream anddownstream pressure sensors pressure sensors IV line 14 to sense pressure. This through-wall measurement avoids the need for separate connections to the fluid-contacting pressure sensor and the problems of sterilization of a fluid-contacting pressure sensor. In such a through-tubing sensing system, the spring-loaded plunger deforms a portion of a wall of theIV line 14 as held against a backstop. Under a known spring biasing force, the amount of deflection of the wall may be measured to deduce internal pressure. Generally, lower pressures of the contained medicament will allow greater deflection of the wall of theIV line 14 and higher pressures of contained medicament will allow less deflection of the wall of theIV line 14. The system may be calibrated for a particular material of theIV line 14. - All electrical components in the
upper electronics portion 18 maybe supplied with power by a containedstorage battery 49 that may provide its power directly or through standard power processing circuits such as regulators and the like. - Referring now to
FIG. 4 , during normal operation, a clinician will enter a total volume to be infused 52 and an infusion rate 54, as shown byprocess block 50, by using theuser interface 26 shown inFIG. 2 . In order to prevent tampering or inadvertent change in these values, their entry is accomplished through a password which must be entered first, indicated byprocess block 56. The password may employ a predetermined sequence of pressing of the pushbuttons 30 (for example, after the unit is turned on but before it is programmed) such as pressing therun pushbutton 30 a once and thestop pushbutton 30 b twice. Such use of thepushbuttons 30 may be without regard to the actual labels of the button as, in this example, “run” and “stop”. - The total volume to be infused 52 and the infusion rate 54 are then used to compute a
total infusion time 58 that may, but need not be, a continuous time period but which may also be a cumulative time necessary for the infusion, contemplating that the infusion may be started and stopped by the patient. The total volume to be infused 52 and theinfusion time 58 represent received protocol instructions (either direct or indirect) from a clinician describing the intended operating limits of the fluid pump in a treatment protocol. - At succeeding
process block 60, the total volume to be infused 52 is compared against a preset software-enforcedvolume limit 62 of thepump 10 after the software-enforcedvolume limit 62 is reduced by the cumulative pumpedvolume 66. The cumulative pumpedvolume 66 is set to zero when theambulatory pump 10 is manufactured and then increases with operation of thepump assembly 42. Similarly, thetotal infusion time 58 is compared against a preset software-enforcedtime limit 64 as reduced by the cumulativepump operation time 68. The cumulative pump operation time is also set to zero when theambulatory pump 10 is manufactured and then increases with operation of theambulatory pump 10 determined from activation of the onpushbutton 30 f not necessarily including activation of thepump assembly 42. The net effect ofprocess block 60 is to see if the intended treatment protocol can be performed before the service life of the pump has been exceeded. - If either the use-adjusted, software-enforced
volume limit 62 or software-enforcedtime limit 64 have been exceeded, as determined atdecision block 70, theprogram 40 proceeds to processblock 72 and provides a warning that the treatment protocol may not be implemented as displayed on thedisplay 28 ofFIG. 2 . Theprogram 40 then returns theprocess block 50 without operation of thepump assembly 42 and a new password and new values must be entered if operation is to be continued.Decision block 70 may also check for adequate remaining battery energy for the protocol using an internal time-to-ampere-hour conversions based on the current drain of the ambulatory pump and comparing that against the estimated total ampere-hours of the battery. - If at
decision block 70, the treatment protocol may be performed within the service limits of thepump 10, then the program proceeds todecision block 74 and may begin operation as indicated byprocess block 76, when therun pushbuttons 30 a is pressed. The program loops until therun pushbutton 30 a is pressed or the unit is switched off. - It will generally be understood that except through operation of the
program 40 executing on themicrocontroller 36, thevalues memory 38 may not be changed and theprogram 40 does not allow these values to be changed by the operator through theuser interface 26. More generally, these values may not be changed by removing power from the ambulatory pump 10 (e.g. removing battery 49 shown inFIG. 3 ) and generally require disassembly of thepump 10 to obtain direct access to the pin structure of themicrocontroller 36 and specialized equipment to access the memory directly if that is even possible. It is contemplated that these values may be stored in a way that cannot be changed without destruction of theambulatory pump 10 ormicrocontroller 36. - The operation of the pump at
process block 76 will normally monitor thepressure sensors pump assembly 42 which may be reactivated after correction by the user. Duringprocess block 76, pump flow-rate is controlled by controlling the speed of thepump assembly 42 in open loop fashion according to the entered infusion rate 54. During operation, the pump's 76 accumulated time and pumping volume perprocess block 77 are used to update cumulative pumpedvolume 66 and cumulativepump operation time 68. - Periodically during operation of the pump at process block 76 (or enforced on an interrupt basis),
decision block 78 may be polled to see if thestop pushbutton 30 b has been pressed in which case thepump assembly 42 stops and theprogram 40 returns todecision block 74. - If the
stop pushbutton 30 b ofdecision block 78 has not been pressed, theprogram 40 proceeds todecision block 80 to determine whether the total volume through theambulatory pump 10 during this treatment protocol has reached the total volume to be infused 52. If so, theprogram 40 loops back toprocess block 50, but if not the program returns to processblock 76. - It should be noted that the updating of the cumulative values per
process block 77 looks at actual rather than estimated hours and volumes pumped in contrast to the calculation ofprocess block 60. - Referring now to
FIGS. 2 and 6 , the upper surface of thelower clamp portion 20 may provide for a shallow tray having upstanding peripheral longitudinally-opposedend walls sidewalls end walls 90 may include notches receivingretention bushings 98 a and 98 formed in theIV line 14 to prevent longitudinal movement of theIV line 14 with respect to thelower clamp portion 20 along thelongitudinal axis 22. - Between the
bushings IV line 14 may be replaced with a silicon material that is softer and more conducive to peristaltic pumping and through-wall pressure sensing. The portion of theIV line 14 within the tray of thelower clamp portion 20 may be held byguides 100 which form notches to align and retain theIV line 14 with theperistaltic plunger elements 44 and the downwardly extending operators of thepressure sensors bottom wall 101 ofupper electronics portion 18. Theguides 100 may also provide for backstops holding theIV line 14 against the pressure of the downwardly extending operators of thepressure sensors peristaltic plunger elements 44. - The
IV line 14 may pass through a springbias clamp element 102 that automatically clamps theIV line 14 when thelower clamp portion 20 is separated from theupper electronics portion 18. -
Rear sidewall 96 includes upwardly extendingopen hinge collars 104 spaced along its edge that may attached to and hinge abouthinge pin 106 supported at a rear edge of thebottom wall 101 of theupper electronics portion 18, spaced below thebottom wall 101 and generally parallel to thelongitudinal axis 22. -
Front sidewall 94 includes longitudinally-extendingtabs 107 that may be engaged by correspondinghooks 108 extending down from the front edge of thebottom wall 101 of theupper electronics portion 18 and activated byrelease slide 32 as will be described to move generally along thelongitudinal axis 22. When thelower clamp portion 20 is attached by the interconnection ofopen hinge collars 104 andhinge pin 106 and pivoted upward toward the bottom 101, thehooks 108 may pass over and attach to thetabs 107 to retain theupper electronics portion 18 andlower clamp portion 20 together with theIV line 14 in proper alignment and clamp therebetween. - By attaching the
lower clamp portion 20 to theupper electronics portion 18 at multiple points across the narrower dimension of thelower clamp portion 20, reduced flexure of thelower clamp portion 20 may be obtained (as opposed to attachment atend walls 92 and 90) against the forces of theperistaltic plunger elements 44 andpressure sensors lower clamp portion 20. This allows reduced material costs for thelower clamp portion 20 and provides increased accuracy, for example, in the pressure sensing. - Referring now to
FIG. 5 , the downwardly extendinghooks 108 may be attached to acommon driver bar 110 that is longitudinally spring biased by aspring 112 into engagement with thetabs 107 tending to hold thelower clamp portion 20 against theupper electronics portion 18. Thebar 110 may communicate withrelease slide 32 which may be pressed rightward against the biasingspring 112 to allow release of thehooks 108 from thetabs 107. Leftward motion of thebar 110 is only possible, however, whensafety lock 34 is pressed inward against biasingspring 112 in a direction perpendicular to thelongitudinal axis 22 allowing a longitudinally-extendingopening 114 in thesafety lock 34 to align with thedriver bar 110 permitting rightward movement of an extension of thecommon driver bar 110 through the longitudinally-extendingopening 14. Because the motion of theclamp release slide 32 andsafety lock 34 are in different directions and they are located in separated positions, accidental release of thelower clamp portion 20 is greatly reduced. - Certain terminology is used herein for purposes of reference only, and thus is not intended to be limiting. For example, terms such as “upper”, “lower”, “above”, and “below” refer to directions in the drawings to which reference is made. Terms such as “front”, “back”, “rear”, “bottom” and “side”, describe the orientation of portions of the component within a consistent but arbitrary frame of reference which is made clear by reference to the text and the associated drawings describing the component under discussion. Such terminology may include the words specifically mentioned above, derivatives thereof, and words of similar import. Similarly, the terms “first”, “second” and other such numerical terms referring to structures do not imply a sequence or order unless clearly indicated by the context. Indication is used herein to mean any type of sense to indication including an audio alarm, visual display or other computer-controlled activation (motor buzz, etc.)
- When introducing elements or features of the present disclosure and the exemplary embodiments, the articles “a”, “an”, “the” and “said” are intended to mean that there are one or more of such elements or features. The terms “comprising”, “including” and “having” are intended to be inclusive and mean that there may be additional elements or features other than those specifically noted. It is further to be understood that the method steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the particular order discussed or illustrated, unless specifically identified as an order of performance. It is also to be understood that additional or alternative steps may be employed.
- References to “a microprocessor” and “a processor” or “the microprocessor” and “the processor,” can be understood to include one or more microprocessors or other types of computers, gate arrays or the like that can execute programs and communicate with each other. Furthermore, references to memory, unless otherwise specified, can include one or more processor-readable and accessible memory elements and/or components that can be internal to the processor-controlled device, external to the processor-controlled device, and can be accessed via a wired or wireless network. The term manual pushbuttons means buttons that may be operated by finger touch or the like including touchscreen and passive switch and mechanical switch.
- It will be appreciated that the look-ahead operation of the
ambulatory pump 10 described herein is consistent both with anticipatory locking of the pump so that the pump does not exceed the service values, as well as setting the service values to a value below the actual longest desired service value by amount of the typical treatment protocol and allowing the treatment protocol to exceed the service value once, and then locking out pump. In this latter case, the pump lockout anticipates that the next treatment protocol would exceed the remaining operating time or volume (which is a negative value) and need not actually accept a new protocol. - It is specifically intended that the present invention not be limited to the embodiments and illustrations contained herein and the claims should be understood to include modified forms of those embodiments including portions of the embodiments and combinations of elements of different embodiments as come within the scope of the following claims. All of the publications described herein, including patents and non-patent publications, are hereby incorporated herein by reference in their entireties.
Claims (19)
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.
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CN201510462990.5A CN105381518A (en) | 2014-08-28 | 2015-07-31 | Low-cost ambulatory medical pump |
CN201911029878.7A CN110841135B (en) | 2014-08-28 | 2015-07-31 | Medical tube assembly |
US16/207,620 US10869963B2 (en) | 2014-08-28 | 2018-12-03 | Low-cost ambulatory medical pump |
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WO2019183088A1 (en) * | 2018-03-20 | 2019-09-26 | Becton, Dickinson And Company | Medical infusion pump for delivery of a fluid |
AU2019239845B2 (en) * | 2018-03-20 | 2021-12-02 | Becton, Dickinson And Company | Medical infusion pump for delivery of a fluid |
US11642461B2 (en) | 2018-03-20 | 2023-05-09 | Becton, Dickinson And Company | Medical infusion pump for delivery of a fluid |
JP2019176983A (en) * | 2018-03-30 | 2019-10-17 | テルモ株式会社 | Chemical liquid administration device |
US20210361855A1 (en) * | 2020-05-20 | 2021-11-25 | Zyno Medical, Llc | Ambulatory Medical Pump Cartridge Locking System |
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Also Published As
Publication number | Publication date |
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CN110841135B (en) | 2022-08-26 |
US10869963B2 (en) | 2020-12-22 |
CN110841135A (en) | 2020-02-28 |
CN105381518A (en) | 2016-03-09 |
US20190099552A1 (en) | 2019-04-04 |
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