TECHNICAL FIELD The present invention relates to a infusion device such as a syringe pump or a infusion pump for administering a drug to a patient, and more particularly to a infusion pump which presses a infusion tube to infuse a liquid drug.
BACKGROUND ART For infusions conducted in medical institutions or medical care at home, problems sometimes occur in setting a infusion flow rate and a dose to be infused. Consequentially, safer infusion devices are required. In conventional infusion devices, an operation panel is used as an user interface that includes a setting input key for setting a flow rate, a volume to be infused or various warnings and a display unit for displaying them (Japanese Patent Laid-Open No. 9-154943 and Japanese Patent Laid-Open No. 2000-300667).
DISCLOSURE OF THE INVENTION Conventional devices, however, have problems setting an input suitable for a field of use cannot be performed (for example, setting the input for many flow rates). The present invention is achieved to solve the conventional problems, and has an object to provide a infusion device that is easily usable by use with high safety, and more particularly, a infusion device including a user interface capable of providing a necessary alarm to a user (a healthcase worker) to eliminate the problems in setting a dose and flow rate before a infusion and allowing the user to set the alarm condition.
The above described object is achieved by a infusion device including: a setting unit for setting a dose and a infusion flow rate, or the like; and a display unit for displaying the dose and the infusion flow rate, or the like, wherein when the infusion flow rate (mL/h) is input via the setting unit, the flow rate is increased or decreased step by step followed by a buzzer sound for each press of an input key. The above described object is also achieved by a infusion device including: a setting unit to set a dose and a infusion flow rate, or the like; and a display unit to display the dose and the infusion flow rate, or the like, wherein thresholds of the lengths of detected air is classified into two predetermined stages so that either thereof can be selected. The above described object is also achieved by a infusion device including in a door: a setting unit to set a dose and a infusion flow rate, or the like; and a display unit to display the dose and the infusion flow rate, or the like, wherein setting an input in the setting unit is prevented while the door is kept opened and/or during the start of a infusion (during a infusion operation).
As described above, according to the present invention, a infusion device is provided that allows a user to set infusion conditions safely and reliably, and also the easy setup or adjustment or selection of a necessary alarm (warning) condition via a user interface including an operation panel. Further, detailed organization of the present invention will become more apparent from the following description of the best implementation of the invention and its accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGSFIG. 1 is an overall appearance perspective view of a infusion device according to the present invention with its door being opened;
FIG. 2 shows an operation switch panel according to the present invention;
FIG. 3A is a perspective view of a door side sensor (a transmitting element)31 facing a base side sensor (a receiving element)30;
FIG. 3B is a sectional view of a state wheredoor4 is closed to hold ainfusion tube2;
FIG. 4 shows the flow of air detection according to the present invention;
FIG. 5A shows the rear surface of the infusion device1;
FIG. 5B is a perspective view of the bottom surface of the infusion device1;
FIG. 6 is a block diagram of the infusion device according to the present invention; and
FIG. 7 shows the flow of a subroutine for setting inputs according to the present invention.
DESCRIPTION OF SYMBOLS- 1 infusion device
- 2 infusion tube
- 4 door
- 6 operation indicator
- 8 the drip number setting switch
- 9 volume to be infused/volume infused setting switch
- 11 flow rate setting switch
- 13 check timing display unit
BEST CONFIGURATION FOR CARRYING OUT THE INVENTION Now, a preferred embodiment of the present invention will be described in detail with reference to the accompanying drawings.FIG. 1 is an appearance perspective view of a state where a peristaltic infusion device1 as an example of a infusion device is secured to ainfusion pole90 with its door being opened,FIG. 5A is a rear perspective view, andFIG. 5B is a bottom perspective view.FIG. 6 is a block diagram. In the state inFIG. 1 a flexible infusion tube2 (seeFIG. 2) described later is set in the infusion device. The infusion device is used with thedoor4 being closed. In this state of use, the outline dimension of a devicebody excluding handle5 provided in the upper unit and the right andleft protrusions3a(the right one only is shown inFIG. 1) is about 19 cm wide, about 16 cm high, and about 16 cm deep.
The infusion device1 has securingfittings91 on its a rear surface, into which asecuring knob92 is screwed so as to be secured to theinfusion pole90 as shown inFIG. 1. The infusion device1 can be secured at any height of theinfusion pole90 as required for particular use. Further, the infusion device1 has fourrubber feet93 secured to its bottom surface so that the infusion device1 can also be used on a desk beside a patient after being removed from theinfusion pole90.
Thus, the device is designed so that a user (an operator such as a healthcare worker, for example, a doctor or a nurse) presses each switch with his/her thumb with the remaining fingers resting on back sides of the right andleft protrusions3afor an easy pressing of the various switches in order to improve usability when setting (mounting) the infusion tube2 (seeFIG. 2). The right andleft protrusions3a(theright protrusion3aonly is shown inFIG. 1) are integrally molded with abody base3 that is made of reinforced plastic or an aluminum die casting, resistant to impact and have vertically sufficient lengths as shown. With the right and left protrusions (projections)3a, abody facing cover12 of the infusion device1 has a wider width than thedoor4, and thus even if the infusion device1 falls onto the floor, thebody facing cover12 hits the floor before thedoor4 hits the floor because of the center of gravity of the infusion device1, thereby protecting the infusion device1 and thedoor4 from strong impact when falling.
Two upper andlower grooves3mused to laterally hold theinfusion tube2 at the center of thebody base3 as shown are integrally molded, and the user vertically sets theinfusion tube2 in thegrooves3m. Apump mechanism100 is fixed in the middle of the grooves by fourscrews110 attachable and detachable using a tool. Thepump mechanism100 includes ten fingers10-nindividually driven by cam drive means included in thebody base3. Each of the fingers10-nis injection molded out of thermoplastic resin such as a polyacetal resistant to chemicals. In the lower unit of thebody base3,jaws3kprotruding to the front in the sheet surface are integrally molded so as to surround thegroove3m, and if a lower side surface of a below describeddoor facing cover12 is placed on thejaws3kwhen thedoor4 including thedoor facing cover12 is closed to apply any external force, thejaws3kreceives the external force to prevent the external force from being applied to thedoor facing cover12 and thedoor4 in order to prevent breakage. Ahook59 is secured to the right side substantially in the middle of thebody base3, and a lock unit of adoor lock lever7 rotatably provided in thedoor4 is locked to thehook59 to maintain thedoor4 secured to thebody base3. Adoor seal rubber66 made of an elastomer is provided in thedoor4 at a unit facing the most upstream side of thegroove3m, and thedoor seal rubber66 is deformed so as to form a joining seal surface with a shownshaping unit3jof thebody base3 when thedoor4 is closed, thereby preventing a liquid drug or the like from entering the infusion device1.
Aocclusion sensor62 is provided below thepump mechanism100, and holds theinfusion tube2 in front and back directions together with aocclusion pressure plate69 provided in thedoor4 to face theocclusion sensor62. Theocclusion sensor62 includes a permanent magnet and a pickup sensor to detect the moving distance of the permanent magnet in an analog manner, and is adapted to detect the position of the permanent magnet moved according to internal pressure changes depending on occlusion states of theinfusion tube2. For this purpose, it is necessary that theocclusion pressure plate69 does not regulate internal pressure changes of theinfusion tube2 in any directions, and thus a shown disk is held to be freely movable by a leaf (an elastic member). When a occlusion threshold is detected by theocclusion sensor62, the adjustment means (selection means)51 (seeFIG. 5B) provided at the bottom surface of the infusion device1 can be adjusted (selected) (a plurality of stages) within 10 stages ranging from 30 to 170 kPa using a driver manipulated by a user or a serviceman for maintenance according to the manufacturer or the type ofinfusion tube2 used. Abase side sensor30 that forms one side of the air-insensor30athat transmits and receives ultrasound to detect the presence of air entering theinfusion tube2 is secured between theupper groove3mand thepump mechanism100 in achamber unit3hformed in thebody base3 as shown. Adoor side sensor31 that forms the other side of the ultrasonic air-insensor30ais secured to thedoor4 as shown. With this organization, thedoor side sensor31 can fit into thechamber unit3hof thebody base3 with thedoor4 being closed to hold theinfusion tube2 with the sensors from the front and back directions, thereby maintaining theinfusion tube2 immobile.
On the other hand, thepump mechanism100 and thebody base3 are substantially colored in gray, whilegroove parts94 and95 secured to upper and lower units of thepump mechanism100 are red or orange, so that the user sets theinfusion tube2 in the grooves to correctly hold theinfusion tube2 in a predetermined position of thepump mechanism100. InFIG. 1, thedoor4 is shown opened and substantially flush with a left side surface of thebody base3. Thedoor4 is opened to a maximum angle of approximately 105 degrees with respect to the surface of thebody base3, and stopped at this position. The middle opening or closing positions for thedoor4 are rotatably supported byhinges65 so as to prevent rattling. The hinges65 include unshown springs.
Thebody facing cover12 specially injection molded of thermoplastic synthetic resin is provided so as to prevent surface sink or a residue of resin flow, and is detachable so as to cover four corners of thebody base3 in the infusion device1. Thus, thebody facing cover12 is detached to be easily accessible to all check spots and parts replacement spots in the infusion device1, thereby facilitating assembly and also maintenance and parts replacement. Apressure plate70 is provided on a rear surface of thedoor4 as described later. Aflexible cable63 is provided with part thereof being exposed as shown between the upper andlower hinges65 and65 for supplying power and transmitting electric signals so that the supply of power and the transmission of electric signals to thedoor side sensor31 can be performed besides the operation switch panel (seeFIG. 2).
FIG. 5A shows the rear surface of the infusion device1, andFIG. 5B shows its bottom surface. On the rear surface of the infusion device1 ofFIG. 5A, akey lock switch52 for disabling the operation of the operation panel after the start of a infusion operation, aDC connector53, andrip sensor connector54, a infusion setdisplay changeover switch55, an external communication unit mounted on each board (an external communication connector)56, andrip sensor holder93c, a fuse holder, and an AC power supply connector (a receptacle), or the like are arranged. In the bottom surface of the infusion device1 ofFIG. 5B, adjustment means (an adjustment switch)50 that serves as both a voice guide selection means (a voice guide selection switch) and the drip number selection display means (the drip number selection switch) is provided. A requested voice guide can be selected from avoice IC chip70, and optimum voice guidance can be performed at each medical field. The volume of the voice guide can be set by continuously pressing the volume to be infused setting means (a volume to be infused setting switch)9 while pressing the flow rate setting means (a flow rate setting switch)11 that also serves as an adjustment means (setting means) so that the display on the flowrate display unit32 is successively changed from A-1 (volume: low) to A-2 (volume: middle), A-3 (volume: high), and A-1 (volume: low) for each press of theup switch22cof the up-down switch22. Also, a infusion setselection panel8 is configured that when a infusion tube (a infusion set)2 is not used, user can not set the drip number for the infusion. The adjustment means50 may be separately provided. Aclamp mounting screw93ais also provided.
Next,FIG. 2 shows a front view of anoperation switch panel1000 provided in a front side of the infusion device1 in the state after theinfusion tube2 has been set (mounted) and thedoor4 has been closed. InFIG. 2, components described above are denoted by the same numeral reference and consequently their descriptions will be omitted. Ainfusion bag300 containing a predetermined liquid drug is hung on the infusion pole, and the most upstream side of theinfusion tube2 is connected to theinfusion bag300. The middle unit of theinfusion tube2 is set in the infusion device1 as shown, while anintravenous needle304 is connected via aroller clamp303 further downstream of theinfusion tube2, and theintravenous needle304 is punctured into the vein of a patient to infuse the liquid drug at a predetermined rate. Theroller clamp303 acts in the same manner as a clamp mechanism500 (seeFIG. 1) in the infusion device1, but an operation (open/close operations) of theroller clamp303 is sometimes forgotten, which forces the user to operate theroller clamp303 through the voice guide. As described above, theinfusion bag300 is hung on an unshown infusion pole (a infusion stand) to allow high accuracy infusion to a patient lying on a bed.
The middle unit of theinfusion tube2 is temporarily set as shown, and then thedoor4 is closed and locked throughlever7 to start a infusion. The display units of the drip number, a volume to be infused (a dose to be infused)/volume infused, and a flow rate (a infusion flow rate) display numeral by a so-called seven segments numerical. Theoperation switch panel1000 is provided in thedoor4. Thedisplay units8,23 and32 for displaying the drip number, the volume to be infused/volume infused, and the flow rate are laid out in theoperation switch panel1000 so as to be easily viewable. The display units are color-coded so that thedisplay unit32 of the flow rate is an orange LED, thedisplay unit23 of the volume to be infused/volume infused is a green LED, and thedisplay unit32 of the flow rate is displayed to be larger than thedisplay unit23 of the volume to be infused/volume infused. The key panel on which the operation switches are placed and thedisplay units8,23 and32 of the drip number, the volume to be infused/volume infused, and the flow rate are made of a transparent resin film having a back surface on which predetermined items are printed and embossed to protrude forward in a circular shape, and bonded to cover unshown included switch keys, thereby preventing the liquid drug or the like from entering the switch keys.
The above described switch keys are mounted on a common board, and LEDs of thedisplay units8,21,23,25,26,27,28, and32 emit light so that the displays are easily viewable even when it is dark. The switch keys, thedisplay units8,21,23,25,26,27,28, and32, and lamps are connected to a below described control unit via theflexible cable63, and power is supplied. Electric signals of control signals and drive signals are transmitted from the cable to allow the supply of power and the transmission of the electric signals of the control signals and the drive signals to perform without trouble the opening and closing operations of thedoor4 including thedoor facing cover12. A board provided in thedoor4 handles so-called TTL level electric signals only.
Next, the function of each switch will be described. Apower switch15 provided in a lower left corner in the drawing is used for turning on/off a main power supply. It turns on the power supply if being pressed for a predetermined amount of seconds (about 2 seconds) and it turns off the power supply if being pressed again for a predetermined amount of seconds (about 3 seconds or more), which prevents the power supply from being accidentally turned on/off. Abattery lamp16 on the right of thepower switch15 includes a green light emitting diode to indicate the three stages as shown. It also lights up when an AC power supply or a dedicated DC power supply is connected irrespective of the on/off state of the power supply to indicate that a battery is being charged. Further, thebattery lamp16 indicates the amount of charge during the charging and the remaining amount during use of the built-in battery with the LED. On the left of thebattery lamp16, an AC/DC lamp17 lights up only when a commercial power supply or a DC power supply is used and the power supply is on. A stop andsilence switch18 that is pressed during the infusion to cause a built-in buzzer to sound in order to stop the infusion is provided above the AC/DC lamp17. The stop andsilence switch18 can be pressed while the warning sound (the buzzer) is emitted to silence the sound. Also, when in a state of being ready for the infusion the stop andsilence switch18 is continuously pressed for predetermined seconds (about 2 seconds), a mode is changed to standby mode. By changing to standby mode, an alarm state for a caution against forgetting to start is released. This can prevent the alarm (the buzzer) from being generated during the time between completion of the puncture of a needle into a patient and the start of the infusion, for example, in an operating room. In a condition where the alarm state is not released, the alarm (the buzzer sound) is generated after predetermined minutes (about 20 minutes) to urge the user to start the infusion. On the left of the stop andsilence switch18, astop display lamp21 having a diode that emits an orange light blinking during a stop is provided in association with the stop andsilence switch18 so as to be surrounded by the same frame. On the right of the stop andsilence switch18, astart switch19 is provided. Thestart switch19 is pressed to cause a built-in buzzer to sound to start the infusion. The green light emitting diode of thestart display lamp20 blinks to indicate that the operation is being performed. An operation indicator6 (seeFIG. 1) provided to protrude from an upper part of thedoor4 also has a green light emitting diode blinking at intervals according to the dose (the infusion rate) so that the operation state is visible from a distant position. On the left of the stop andsilence switch18, a fast-forward switch36 is provided, and when pressed it allows the liquid to be delivered at a rate higher than the set rate (mL/h) during the pressing.
Adisplay unit1100 is provided above the switches, six up-downswitches22, all are provided as shown, so as to correspond to a 3-digit display unit of the flow rate display unit (a infusion flow rate display unit)32. Up and downbuttons22a,22b, and22cof the up-down switch22 corresponding to the number of digits (hundreds, tens, ones) are pressed in a stop state to allow setting the input of the flow rate (the infusion flow rate) (mL/h) and the volume to be infused (the dose to be infused) (mL) within a range of 1.0 to 500 mL/h and 1 to 9999 mL, respectively. On the left of the flowrate display unit32, the flow rate setting means (the flow rate setting switch)11 that is pressed to enter the setting mode is provided. In setting the flow rate (mL/h), the up and downbuttons22aare continuously pressed to increase and decrease the value hundreds by hundreds, and a buzzer sounds synchronized with the increase and decrease of the value at each press. When setting the flow rate (mL/h), first, the flow rate setting means (the flow rate setting switch)11 is pressed to confirm the blinking state, then the value is input by the up-down switch22 to confirm that the value is a predetermined value, and the flow rate setting means (the flow rate setting switch)11 is pressed again to set the input. Above the flowrate display unit32, an volume infused and volume to be infuseddisplay unit23 surrounded by a printed separate frame is provided. A set range for the volume to be infused varies between 1 to 9999 mL by pressing the up and downbuttons22a,22b, and22ccorresponding to the number of digits of the up-down switch22. This set range is programmed to be increased by 1 mL increments or set freely, and adapted to store the set value in a storing unit71 (seeFIG. 6). On the left of the volume infused and volume to be infuseddisplay unit23, the volume to be infused settingswitch9 is provided. This switch is pressed to confirm the set volume to be infused. The volume infused is programmed to be displayed in 1 mL increments, thus the volume infused display range is 0.0 to 9999 mL. For the flow rate (mL/h) and the volume to be infused (mL) after setting the input, when the flow rate (mL/h) is equal to or larger than the volume to be infused (mL), an alarm (a buzzer or a voice notification) is used to notify the user. As an example of the voice notification, a voice such as “Confirm the set flow rate” previously stored in thevoice IC chip70 is used to notify to the user. Thedisplay unit1100 uses LED elements and is visible even in a dark room without illumination. The infusion device1 also includes a flow rate upper limit setting function.
Above the volume infused and volume to be infuseddisplay unit23, infusion setting means (the drip number setting means)8 is provided to set the drip number of infusion using a drip chamber and confirm the setting afterwards. On its right, acompletion display unit24 displays the characters “completed” blinking. Below thecompletion display unit24, a timingvalidation display unit13 is provided to send either a notification regarding the approach of a regular check timing or a notification regarding a regular check by illuminating either a pictographic character of a driver from a back surface or an LED display. When thedisplay unit13 is made of LED, the display colors may be changed. For instance, the display is orange for a predetermined period of days, i.e., a few days before the regular check timing (date), and the display turns red after the regular check date. Setting a time period before the transfusion system lights up can be done at configuration. For example, continuously pressing the volume to be infused setting means (the volume to be infused setting switch)9 while pressing the flow rate setting means (the flow rate setting switch)11 enables a user to set a time using the upswitch22bof the up-down switch22 so that the display on the flowrate display unit32 is successively changed from 0 (no setting) to 1 (month), 2 (months), . . . 12 (months). When setting, timing validation may be controlled by a host computer using an internal communication means such as a LAN connection via anexternal communication unit56.
Further, anocclusion display unit26 displaying the blinking characters “occlusion” when an occlusion in theinfusion tube2 is detected by theocclusion sensor62, urges a user to disable the infusion. A dooropening display unit27 is provided to display the blinking characters “door” when the door is not closed incompletely with respect to thebody base3 and an open state is detected by the door switch. An air-indisplay unit28 is provided to display the blinking characters “air-in” when the air-insensor30adetermines that an air of a predetermined length (10 mm or 5 mm) has entered theinfusion tube2. An lowbattery display unit29 is provided to display the blinking characters “battery” when the voltage of the built-in battery is low. An abnormal flowrate display unit25 is provided to display an abnormal flow rate. All previous displays are provided as alarm display units surrounded by the same printed frame. More particularly, when the door switch63 (seeFIG. 6) determines that thedoor4 is opened or incompletely closed with respect to thebody base3 in the stop state of the infusion operation because of an alarm or the like, any operation of the operation switch panel is prohibited to prevent setting an input. An input setting subroutine is shown inFIG. 7 regarding this last case. InFIG. 7, it is first determined whether the operation is being stopped (Step S101). When it is determined that the operation is being stopped, it is determined whether thedoor4 is opened (Step S102). (When it is determined in Step S101 that the operation is not being stopped, that is, the operation is being performed, the process returns to the original routine to prohibit a setting input operation (Step S109)). When it is determined that thedoor4 is not opened (closed), it is determined whether the flow rate setting is selected (Step S103). (When it is determined in Step S102 that thedoor4 is opened, the process returns to the original routine to prevent the occurrence of a setting input operation (Step S109)). When the flow rate setting is selected, a flow rate setting change is performed (Step S108). When the flow rate setting is not selected, it is determined if the volume to be infused setting is selected (Step S104). When the volume to be infused setting is selected, a volume to be infused setting change is performed (Step S107). When the volume to be infused setting is not selected, it is determined if the drip number setting is selected (Step S105). When it is determined that the drip number setting is selected, a drip number change is performed (Step S106). When it is determined that the drip number setting is not selected, the process returns to the original routine to prevent the occurrence of the setting input operation (Step S109). The process also returns to the original routine after the processing of Step S106, Step S107, and Step S108 to prohibit a setting input operation (Step S109). The order of the routine processing constitutes an example and does not limit the step of the invention.
As described above, the operation switch panel as a user interface is designed so that the user can set and confirm the infusion conditions safely and reliably and before starting a infusion. Adoor base4apartially shown by a broken line in the lower left part of the drawings is made of aluminum die casting or rigid resin, and has a key surface formed between the side surface and the front surface.
FIG. 3A andFIG. 3B are perspective and sectional views of the air-insensor30a.FIG. 3A is a perspective view of the door side sensor (a transmitting element)31 facing the base side sensor (a receiving element)30, andFIG. 3B is a sectional view of the state where thedoor4 is closed to hold theinfusion tube2. Thedoor side sensor31 facing thebase side sensor30 includes a pair of transmitting elements and receiving elements. The determination that there is an air in theinfusion tube2 is made through the following flow (FIG. 4). First, the user selects the length (a threshold) of air from 5 mm (mainly for children) or 10 mm (mainly for adults) that are required to be detected. Air-in detection sensitivity is selected by pressing the volume to be infused setting means9 as selection means while pressing the flowrate setting switch11 as air-in sensor sensitivity selection means (a selection switch) so that a display on thedisplay unit32 is successively changed from 5 to 10, to 5, and to 10 for each pressing of the volume to be infused settingswitch9. When the display is “5”, the length threshold for the detection of air in theinfusion tube2 is 5 mm, and when the display shows “10”, the length threshold is 10 mm. Either one of the thresholds is thus selected (Step S1) to cause either “5” or “10” to be displayed as the selected (set) value (Step S2). All input setting conditions such as the flow rate and the volume to be infused are ready, and thestart switch19 is then pressed to start the infusion (Step S3). Air-in detection is performed during the infusion (Step S4), and when there is an air in theinfusion tube2, the value detected by the base side sensor (the receiving element)30 is changed. Thus, the value is counted (in synchronization with the RPMs of a motor driving the fingers10-n) to determine whether the value exceeds the air length threshold. When the value exceeds the threshold, it is determined that there is an air (Step S5), a display is made on the air-indisplay unit28, and an alarm (a buzzer or a voice) is generated (Step S6) to stop (Step S7). A dedicated selection switch may be provided rather than using another switch as the selection switch. Thresholds of lengths of air to be detected by the air-in detection are in a plurality of stages such as “5”, “10”, “15”, “20”, or the like as default values, but the user may select either of two stages of “5” and “10” only. Thus, a safe design is provided such that the user cannot adjust, change, or set the thresholds of the lengths of the air to be detected by the air-in detection. The thresholds can be changed as required by a serviceman for maintenance or the like. The present invention has been described, but various improvements or changes may be made without departing from the purpose of the present invention. The explanations of the present invention are not limited to the embodiment of the present invention but becomes apparent from the accompanying claims.