Patent Description:
In the prior art, infusion pumps which are provided as so-called large volumetric pumps (LVP) comprise large displays and many button keys for carrying out complex programming and infusion management tasks.

<CIT> representing the closest prior art from which the present invention proceeds, discloses a medication infusion safety device for assuring an application of a correct medication to a patient, comprising a memory means adapted to be provided at a medication reservoir containing a medication and to store data identifying said medication, a memory reading means adapted to be provided at an infusion pump unit and to read data from said memory means, and control means adapted to control an infusion in accordance with an evaluation of data read by said memory reading means so that only in case the evaluation leads to the result that the medication is correct it causes the infusion from said medication reservoir to be started, wherein said memory reading means is adapted to read data from said memory means through direct wireless connection and to be enabled to read data from said memory means in case the infusion pump unit is coupled to the medication reservoir with a distance between said memory means and said memory reading means being equal of or lower than a predetermined maximum wireless reading distance.

Nowadays, it is still a standard practice in hospitals to use barcodes for labeling drugs and patient identification bracelets instead of RFID/NFC labels which are just beginning to appear mostly on smart identity cards of the medical staff. It is also known in the prior art that with bedside infusion pumps cable-connected barcode readers are used which however have a rather large size.

Despite of the use of barcode labeling in conjunction with smart pumps, there is still a risk of upstream line mix-ups when a plurality of infusion pumps are used for one and the same patient. This is in particular the case when a nurse in a hurry situation scans a medication reservoir, then takes an upstream tube and the spike of an infusion set installed in an infusion pump where the scan info is transmitted, and connects to a next medication reservoir instead of the scanned one - a medication error that can eventually cause death since an erroneous drug or medication is infused. As described in the literature, this error is not negligible and causes negative impacts on the smart pump and drug library combination safety solution of the prior art.

It is an object of the present invention to eliminate the drawbacks of the prior art and in particular to provide an improved infusion system which allows a better and more reliable handling and operation.

In order to achieve the above and further objects, there is provided an infusion system including.

Preferred embodiments and modifications of the present invention are defined in the dependent claims.

According to a preferred embodiment, the barcode reader is arranged so that it is positioned above the display screen when the infusion pump is in an operating position so as to ensure a correct orientation of the characters shown on the display screen.

According to a still further preferred embodiment, the infusion pump comprises a first surface portion and a second surface portion, wherein the display screen is provided at the first surface portion and the barcode reader at the second surface portion and wherein the second surface portion is arranged at an angle, preferably about <NUM>°, to the first surface portion, wherein in particular the second surface portion forms an end face.

According to a still further modification of the above embodiment, an inlet port is provided at the second surface portion.

According to a still further modification of the above embodiment, the barcode reader is positioned beside the inlet port of the infusion pump.

According to a still further preferred modification of the above embodiment, the infusion pump comprises a first part, preferably a consumable first part, which includes a pump mechanism, and a second part including a motor for driving the pump mechanism of the first part, the first part is reasonably attachable to the second part, the first part is provided with the inlet port, and the second part is provided with the barcode reader.

According to a further preferred embodiment the infusion system comprises a wireless memory provided at a memory supporting element which is attached to the reservoir portion so that in the operating position of the medication reservoir the memory supporting element hangs down from the reservoir portion, wherein the memory supporting element is formed as a flap or tongue, wherein the infusion pump comprises a wireless memory reading unit adapted to read data through direct wireless connection from the wireless memory.

According to a further preferred embodiment, the medication reservoir comprises an outlet port which is in fluid communication with the reservoir portion and is adapted to be coupled directly to an infusion pump, and the memory supporting element is positioned at adjacent to the outlet port.

Preferably, the wireless memory reading unit and the barcode reader are arranged side by side at the infusion pump at a predetermined distance from each other, and the wireless memory and the barcode are arranged side by side at the medication reservoir at a distance from each other essentially corresponding to the predetermined distance between the wireless memory reading unit and the barcode reader at the infusion pump.

The aforementioned and other advantages of the present invention will become apparent from the following more detailed description when taken in conjunction with the accompanying drawings of illustrative embodiments.

In the <FIG> it is shown an infusion pump <NUM> according to a first preferred embodiment which configured as a so-called miniature pump and is part of an infusion system. According to the first preferred embodiment, the infusion pump <NUM> is divided into two parts, i.e. a first part <NUM> including a pump mechanism (not shown) and a second part <NUM> including a motor (not shown) for driving the pump mechanism in the first part <NUM> and further hardware like a display <NUM> with a display screen 8a, slide bars <NUM> and buttons <NUM>. According to the embodiment shown in the <FIG>, the first part defines a consumable pump cartridge <NUM> which is preferably made of plastic resulting in low weight and low manufacturing costs. As further seen from <FIG>, the pump cartridge <NUM> is provided with a spike <NUM> which defines an inlet port of the pump mechanism included in the pump cartridge <NUM> and, hence, of the infusion pump <NUM>, and is further provided with an outlet port <NUM> to which a downstream infusion line is to be connected. The second part defines the rest of the infusion pump <NUM> and defines a pump module <NUM>. The pump module <NUM> which can also be called pump controller has an extremely low weight and a very small size so that it is not bigger than drip sensors of today's bedside pumps and is sufficient to fluidly connect to a medication reservoir <NUM> a lower portion of which is shown in <FIG>, resulting in an extreme easiness of use, wherein the medication reservoir <NUM> is a further part of an infusion system.

As in particular seen from <FIG>, the pump module <NUM> is provided so that its front side 6a also defines the front side 2a of the infusion pump <NUM>. The back side 6b of the pump module <NUM> is provided with a recess <NUM> for accommodating the pump cartridge <NUM>, as shown in <FIG>, so that the back side 4b of the pump cartridge and the remaining free portion of the back side 6b of the pump module <NUM> together define the back side 2b of the infusion pump <NUM>. The pump cartridge <NUM> and the pump module <NUM> are provided with attachment means (not shown) so as to be able to be releasably attached to each other in order to provide the complete infusion pump <NUM>.

As shown in <FIG> and <FIG>, the display <NUM>, the slide bars <NUM> and the buttons <NUM>, <NUM> are provided at the front side 6a of the pump module <NUM> and, hence, at the front side 2a of the infusion pump <NUM>.

In the <FIG>, the infusion pump <NUM> is shown in an operating condition wherein the infusion pump <NUM> is held by a user's hand <NUM> as illustrated in <FIG> or coupled to the medication reservoir <NUM> as illustrated in <FIG>. In the operating condition, the orientation of the infusion pump <NUM> is such that one of its side faces defines an upper end face 2c above the display <NUM>, wherein the upper end face 2c of the infusion pump <NUM> is formed by an upper end face 4c of the pump cartridge and the adjacent upper end face 6c of the pump module <NUM>. Whereas the spike <NUM> and the outlet port 15a are arranged at the upper end face 4c of the pump cartridge <NUM>, a barcode reader <NUM> is provided at the upper end face 6c of the pump module <NUM>.

The barcode reader <NUM>, which is adapted to read a barcode provided at a medication reservoir as described later, is arranged so that the reading direction of the barcode reader <NUM> is oriented away from the display <NUM> essentially in parallel with the plane of the display screen 8a so that in the shown embodiment the angle of the reading direction is about <NUM>° to the plane of the display screen 8a and about <NUM>° to the end face 2c of the infusion pump <NUM>; such an orientation of the reading direction of the barcode reader <NUM> further results in that the end face 2c of the infusion pump <NUM> is arranged at an angle of about <NUM>° to the front side 2a of the pump which is formed by the front side 6a of the pump module <NUM>. As further to be seen from the <FIG>, the barcode reader <NUM> is positioned close to the spike <NUM>.

Preferably, a camera based ultra-miniature electro-optical module is provided as a barcode reader <NUM>. Such modules are available with integrated LED light, which is schematically illustrated besides the barcode reader <NUM> on the upper end face 2c of the infusion pump <NUM> in the <FIG> and <FIG>, and software for image decoding and hand movement illumination and have the advantage to be integrated in the upper end face 2c of the infusion pump <NUM> without increasing significantly the small size of the infusion pump <NUM>. It should be added here that the barcode reader <NUM> can be adapted to read either a one-dimensional barcode or a two-dimensional square-type barcode.

The slide bars <NUM> each are adapted to be touched by a finger 20a of the user's hand <NUM> (<FIG>) which finger when touching the slide bar <NUM> is moved along the length of the slide bar <NUM>. The slide bars <NUM> are used to adjust the value of certain parameters wherein the movement of the finger 20a results in a change of the value of the respective parameter. Concretely, the movement in a first direction, which in the operating condition and orientation of the infusion pump <NUM> according to <FIG> is the upwards direction, results in an increase of the value of the parameter and in a reversed second direction, which in the operating condition and orientation of the infusion pump <NUM> according to <FIG> is the downwards direction, results in a decrease of the value of the parameter. Further, the slide bar is adapted so that the rate of change of the value of the parameter essentially correlates with the speed of movement of the finger 20a and in an idle mode, when the user's finger 20a has been released from the slide bar <NUM>, is decelerated in a similar way as under influence of an inertia load and/or a friction. In <FIG>, the slide bars <NUM> each are shown with an operating portion 10a. In case the slide bars <NUM> are configured as hardware slide bars, the operating portions 10a are sliders of such slide bars. However, in case the slide bars <NUM> are not hardware slide bars, but provided as a new type of a touch input element without a screen (like a keypad of a notebook), the operating portions 10a define the portion where the finger 20a touches the slide bar <NUM>. Preferably, more than one slide bar <NUM> is provided. In the embodiment shown, two slide bars <NUM> are provided which are arranged in parallel with each other. Moreover, in the embodiment shown, the slide bars <NUM> are arranged so that they extend in an essentially vertical direction when the infusion pump <NUM> is held in the operating condition and orientation according to <FIG>.

The buttons <NUM> are provided for selecting among several parameters a predetermined parameter whose value is to be changed through a predetermined one of the slide bars <NUM>, wherein one of the buttons <NUM> is allocated to one of the slide bars <NUM> - except when e.g. three slide bars can adjust two parameters simultaneously.

<FIG> shows a modification which differs from the embodiment as shown in <FIG> in that the display screen 8a is embodied as a touch screen wherein the slide bars <NUM> are provided as a portion of the touch screen. Although in <FIG> the buttons <NUM> are provided as hardware buttons and arranged below the display <NUM>, alternatively they can also be provided as a further portion of the touch screen. According to the embodiment shown in the figures, the infusion pump <NUM> has an elongated shape. Due its small size and its elongated shape, the infusion pump <NUM> can be held by the user's hand <NUM> somewhat like a TV remote control and can further be programmed by a single finger 20a of the user, as also illustrated in <FIG>, so as to achieve a single hand handling and finger programming as well as scanning labels at medication reservoirs or patient bracelets by means of label readers like the barcode reader <NUM> provided at the upper end face 2c. Accordingly the infusion pump <NUM> is also used as a normal barcode reader of the prior art for scanning patient ID and drug labels by moving the infusion pump <NUM> towards and pointing the label by hand. The infusion pump <NUM> beeps when a reading is available, as bar code readers do, and shows on the display <NUM> the reading as part of a "5R" ("right patient", "right drug", "right dosing", "right delivery route", "right time") check and setup.

In the infusion pump <NUM> usually a downloaded drug library is stored so that it can associate a drug name and eventually concentration and volume to a scanned label in case there is a hand written or printed prescription. Since electronics and memories nowadays are extremely small, a big size infusion pump is not needed anymore to integrate big software. The infusion pump <NUM> according to the described embodiment also having Wi-Fi communication and being interoperable by interoperability standards can download a prescription having all "5R" doctors' recommendations for a specific patient.

After scanning a patient and scanning the drug or medication reservoir, this information can be transferred through Wi-Fi to an e-prescription server (not shown) so to send all rest "5R" information, i.e. infusion protocol, delivery route (intravenous or other), and time to start infusion. All this information is then displayed at the display <NUM> of the infusion pump <NUM> and checked by a nurse responsible for the infusion management. The process also eases the programming on the infusion pump <NUM> since patient attributes like age and weight and Body surface Area (BSA) are downloaded and used in drug library limits and dose (ml/Kg/min) calculation. Alternatively, only patient related drugs pending, not yet infused from a drug/pharmacy automation hospital system are shown on the infusion pump <NUM> since drug and patient are identified.

The display <NUM> of the infusion pump <NUM> according to a preferred embodiment is intentionally black and white to significantly reduce power consumption that nowadays is much higher. Whereas a touch screen is unusual to black and white displays, a touch screen display has not much power consumption so that it can be used for the usability it offers.

The touch screen of the display <NUM> for the usability increase provided in infusion pump programming is advantageous for rate calculation and other letter or number selection functions. The slide bar <NUM> that the user's finger 20a (<FIG>) slips over it and the display <NUM> shows a changing number with speed relative to speed of the finger 20a and its acceleration. As already mentioned above, this function mathematically is that of an inertia wheel with some friction: You accelerate it and it continues while decelerating if no more "push" from the finger 20a. When the finger 20a stops on the display <NUM>, the value of the parameter indicated as a number resumes and changes direction if the finger 20a changes so. This is much easier than up/down buttons used in prior art and much more appropriate for the use of the infusion pump <NUM> somewhat like a TV remote control, where slipping a finger is a much natural function. It can be adapted to a large dynamic range of e.g. <NUM>,<NUM> to <NUM>,<NUM>/h rate for speed and easiness of adjustment. A preferred embodiment would have numbers on top and touch-slip-bars at the lower end of the display <NUM>.

Especially for rate programming, there are three variables related by an equation involved in rate programming (the simplest infusion protocol) RATE = VOLUME/TIME.

Since gravity infusions are by far the largest market segment in infusion, delivering just by rate programming and the form and function of the infusion pump <NUM> can also replace gravity infusions, it is provided the simplest user interface to program a rate as follows. Alternatively, three slide bars <NUM> can be used with allowance to simultaneously change only two from the three parameters and adjust all three parameters in real time with the aid of the display <NUM>.

With just two touch-slide bars used, three numbers change calculated real-time. The first represents VOLUME TO BE INFUSED and the second RATE.

While two slide bars <NUM> are operated, the values of the aforementioned three parameters shown on the display <NUM> change after continuous calculation : VTBI as slide bar input, RATE as slide bar input, and TIME=VTBI/RATE. So Volume & Rate or Volume & Time protocols can be programmed with one single display screen 8a.

An OPTIONS touch button for time are hours/min or min only. A UNITS touch button if not pressed slides go to ml/h as RATE XXX. XX ml/h UNITS so that you can still change if UNITS pressed between "ml/h", "mg/h", "mcg/h" and "mg/Kg/min". Both these aforementioned touch buttons are not shown in the figures, but can be additionally provided as further parts of the touch screen according to the modified embodiment of <FIG>. In case of "mg" or "mcg", CONCENTRATION is needed. Concentration if read by drug label needs no entry; if not, a slide bar <NUM> can be used for entering it before programming rate.

In case of mg/Kg/min, Kg of patient is needed. This is also entered by a slide bar <NUM>.

First display options: It appears after a cartridge <NUM> is mounted on the infusion pump <NUM> since there is preferably no ON/OFF button. The infusion pump <NUM> shuts OFF display and keeps location tracking to find its position after it is on standby, and cartridge <NUM> is removed and no touch on buttons or touch screen is done for some time.

and two slide bars <NUM> below for Volume and Rate.

If touched, then a gravity type SIMPLE INFUSION screen is shown, by using two slide bars <NUM> for programming new infusion as shown above. This is an easy way of doing complex things as below, while going directly to program infusions like gravity replacements:.

A bar code or RFID is used to scan patient or drug, and NEW PATIENT entry on the infusion pump <NUM> is sent to a drug library option.

Screen parameters can be entered by scanning barcode or RFID or WiFi transfer or slide in letters all alphabet from A-Z scrolls from slider.

After all this is defined, the infusion pump <NUM> retrieves from a server (not shown here) the rest of 5R as delivery route and time to infusion and the protocol for infusion, and a nurse checks them on the infusion pump <NUM>, and then she can start infusion safely.

This menu adjusts all infusion pump configuration parameters one by one.

For medication safety, scanning a barcode of a drug or a medication reservoir that is few centimeters above the infusion pump that is hanging from its spike is not <NUM>% safe but nevertheless much better than conventional infusion pumps with an upstream tubing that scan a drug reservoir a meter higher. Namely, scanning the wrong medication reservoir is reported as medication error happening many times. According to a preferred embodiment of the arrangement as shown in <FIG>, it is provided a <NUM>% safety.

There is a barcode label <NUM> on the lower border or edge 16a of the reservoir portion 16b being part of the medication reservoir <NUM> so that the barcode label <NUM> is provided as somewhat like a continuation of the lower border or edge 16a of the medication reservoir <NUM>, as shown in <FIG>. Since the barcode reader <NUM> is positioned above the display <NUM> and arranged on the upper end face 2c of the infusion pump <NUM>, when the infusion pump <NUM> is in an operating position according to the <FIG> and <FIG> so as to ensure a correct orientation of the characters shown on the display screen 8a of the display <NUM>, the reading direction of the barcode reader <NUM> is pointed to the barcode label <NUM> at the lower border or edge 16a of the medication reservoir <NUM>, when the medication reservoir <NUM> is also in an operating position according to <FIG>, after the spike <NUM> of the infusion pump <NUM> has been directly connected to an outlet port <NUM> of the medication reservoir <NUM>. As further shown in <FIG>, the barcode label <NUM> is positioned close or adjacent to the outlet port <NUM> at the lower border or edge 16a of the medication reservoir <NUM> so that in the shown embodiment the reading direction of the barcode reader <NUM> is oriented essentially in direction of coupling the spike <NUM> of the infusion pump <NUM> with the outlet port <NUM> of the medication reservoir <NUM>. So, due to the aforementioned configuration it is ensured to allow an appropriate distance between the barcode reader <NUM> and the barcode label <NUM> for correct reading, wherein it is also possible to adjust such a distance by the provisions of spacers at the infusion pump <NUM> and/or the barcode label <NUM>.

For piggyback infusions and conventional infusion pumps having an upstream tubing, a combination of a flow sensor or an active pinch valve or both with a barcode reader configured for a close-up label as described above and facing the barcode label at a specific distance can also achieve a <NUM>% medication safety as the infusion pump senses in one case the flow at start of infusion needing flow increasing from <NUM> and in another case with an upstream pressure reading at starting the infusion, when an active valve is closed, the upstream pressure is decreasing.

The barcode labels of the kind as described above can be printed by a special printer that reads the barcode of a drug and prints a copy on a self-adhesive label that is attached to the lower border or edge 16a of the medication reservoir <NUM> aside the outlet port <NUM> of the medication reservoir <NUM>. Instead of the configuration shown in <FIG>, an L-shaped flap or plate (not shown) can be attached to the lower border or edge 16a of the medication reservoir <NUM>, in particular by bonding, wherein the barcode label is provided at the lower side of the vertical portion of the L-shaped flap or plate protruding from the medication reservoir so that the barcode label faces the barcode reader <NUM> at the top or upper end face 2c of the infusion pump. According to a further modification (also not shown) instead of the configuration shown in <FIG>, the barcode label can be bonded to the lower border or edge 16a of the medication reservoir <NUM> so as to get the shape of an "L" below the lower border or edge 16a of the medication reservoir <NUM>.

<FIG> shows a second preferred embodiment of the medication reservoir <NUM> which differs from the first preferred embodiment of <FIG> in that the outlet port <NUM> comprises a short tube 26a which is in fluid communication with the reservoir portion 16b and extends or suspends downwards when the medication reservoir <NUM> is in an operating position as shown in <FIG>. The lower free end of the tube <NUM> is formed as a connector 26b which is adapted to be directly coupled with an infusion set including a drip chamber and an infusion pump wherein the drip chamber can be preferably provided with an upstream connector (not shown). Attached to the wall of the tube 26a of the outlet port <NUM> is a plate <NUM> which protrudes from the outlet port <NUM> at an angle of about <NUM>° and, with the medication reservoir <NUM> being in its operating position, in an essentially horizontal direction as shown in <FIG>. The lower side of the plate <NUM> facing away from the medication reservoir towards the aforementioned infusion set is provided with a barcode label <NUM>. As further shown in <FIG>, the medication reservoir <NUM> according to the second preferred embodiment comprises a strip <NUM> which is integral with the reservoir portion 16b at its lower edge 16a but separated from the remaining part of the reservoir portion 16b by a perforated line <NUM>. So, the strip <NUM> is provided as a side detachable strip <NUM> which by rupturing the perforated line <NUM> can fold downwards wherein its end 30a will be lower than the level of the lower edge or border 16a of the reservoir portion 16b. The end 30a of the side detachable strip <NUM> is provided with a wireless memory which in the described embodiment is configured as a RFID/NFC label or chip <NUM>. With the side detachable strip <NUM> being folded downwards the RFID/NFC label <NUM> at the end 30a of the side detachable strip <NUM> is positioned within an appropriate distance to a RFID/NFC reader provided on an infusion pump to be described later.

<FIG> shows the medication reservoir <NUM> according to a third preferred embodiment which differs from the second preferred embodiment of <FIG> in that instead of a side detachable strip <NUM> there is provided a tongue or flap <NUM> which is attached to the lower edge 16a of the reservoir portion 16b and suspends or extends downwards when the medication device <NUM> is in its operating position as shown. The flap or tongue <NUM> is provided at its lower free end 26a with the RFID/NFC label <NUM>.

<FIG> shows a fourth preferred embodiment of the medication reservoir <NUM> which differs from the aforementioned second and third preferred embodiments in that the barcode label <NUM> is not provided at the plate <NUM> attached to the tube 26a of the outlet port <NUM>, but at the underside or bottom of a body <NUM> attached to the lower edge 16a of the medication reservoir <NUM> and suspending downwards therefrom wherein the body <NUM> is embodied as a plate or flap which is folded to a triangle whose peak is fastened to the lower edge 16a of the reservoir portion 16b and whose bottom extends in an essentially horizontal direction when the medication reservoir is in its operating position as shown in <FIG>. So, in contrast to the second and third preferred embodiments, in the fourth preferred embodiment of <FIG> the plate <NUM> can be provided for supporting an RFID/NFC label.

All the above described second to fourth preferred embodiments of the medication reservoir <NUM> show a combined use of a barcode and a wireless memory like an RFID/NFC label or chip. Accordingly, the infusion pumps to be coupled with the medication reservoir <NUM> of these embodiments should preferably comprise a barcode label reader as well as a wireless memory reader like an RFID/NFC reader. However, it is also conceivable in principle to use in conjunction with the medication reservoir <NUM> according to the second to fourth preferred embodiments an infusion pump which is only provided with either a barcode reader or a wireless memory reader.

Further, it is conceivable in principle, that with the medication reservoir <NUM> according to the second and third embodiments of the <FIG> and <FIG> the plate <NUM> is not provided with a barcode label or is even completely omitted, and that with the medication reservoir <NUM> of the fourth preferred embodiment of <FIG> the body <NUM> is completely omitted.

<FIG> shows an assembly or arrangement of an infusion pump <NUM> according to a second preferred embodiment with the medication reservoir <NUM> according to the third preferred embodiment of <FIG>. As shown in Fig. 7a, the infusion pump <NUM> comprises - similar to the infusion pump <NUM> according to the first preferred embodiment of <FIG> - as a first part a pump cartridge <NUM> and as a second part a pump module <NUM> which can also be called a pump controller. The pump cartridge <NUM> includes a pumping mechanism which is schematically shown in Fig. 7a and designated by the designating number "42a". The pump module <NUM> includes a motor (not shown) for driving the pump mechanism 42a. At the pump module <NUM> releasably attached is not only the pump cartridge <NUM> but also a drip chamber <NUM>. The drip chamber <NUM> comprises an inlet port <NUM> which is configured as a spike in this embodiment and adapted to be coupled to the connector 26b of the medication reservoir <NUM> and, hence, in this embodiment defines the inlet port of the infusion pump <NUM>. Besides the drip chamber <NUM> there are provided two ultrasound detectors wherein the upstream sensor <NUM> detects drops of the medication fluid so as to verify a correct performance of the infusion pump <NUM> and the downstream sensor <NUM> detects the level of the medication fluid within the drip chamber <NUM> and gives an alarm in case of detection of low level of the medication fluid. The drip chamber <NUM> is connected through a downstream tube <NUM> to the pump cartridge <NUM> which again is coupled to a downstream infusion line <NUM>. As further shown in Fig. 7a, the drip chamber <NUM> is attached to the pump module <NUM> by snap fitting and drip chamber flaps up-stop means <NUM> at the upper end close to its inlet port <NUM>. So, when the infusion pump <NUM> is connected to the medication reservoir <NUM>, the drip chamber <NUM> hangs from the connector 26b of the medication reservoir <NUM> with which the inlet port <NUM> of the drip chamber <NUM> is coupled. Since the drip chamber <NUM> is attached by the snap fitting means <NUM> to the pump module <NUM>, the pump module <NUM> and, hence, the whole infusion pump <NUM> is supported by the drip chamber <NUM>.

In order to read the barcode label <NUM> at the underside or bottom of the plate <NUM>, the pump module <NUM> is provided with the barcode reader <NUM> in a similar manner as the infusion pump <NUM> according to the first preferred embodiment so that regarding arrangement and configuration of the barcode reader <NUM> reference is made to the description of the first preferred embodiment of the infusion pump <NUM>. Further, in order to also be able to read the RFID/NFC chip or label <NUM>, the infusion pump <NUM> is also provided with a wireless memory reader which in the embodiment shown in <FIG> is configured as an RFID/NFC reader <NUM>.

The pump module <NUM> comprises at its front side defining the front side 40a of the infusion pump <NUM> a display <NUM> and buttons <NUM> in a similar manner as the display <NUM> and the buttons <NUM> of the infusion pump <NUM> according to the first preferred embodiment of <FIG>, wherein the buttons <NUM> have functions like purge, start/stop and on/off. In the embodiment of <FIG>, the display <NUM> is a small display which is of black and white LCD technology and always switched on for showing critical information, but with backlight lighting only when needed so as to consume rather small amount of energy. In addition to this small display <NUM>, the infusion pump <NUM> according to this embodiment further comprises at its back or rear side a large color touch display <NUM> which is advantageous for helping complex programming and interconnected services. This display <NUM> is preferably of plastic OLED flexible technology and therefore very thin and light-weight for a device hanging from the outlet port <NUM> of the medication reservoir. The display <NUM> can be covered by very thin glass of flexible glass technology as known in the art and able to prevent scratches without breaking. The display <NUM> turns on only for complex programming and IT networking tasks, and remains off most of the time for sake of large battery autonomy since the small display <NUM> at the front side of the pump module <NUM> consumes much less and, as already mentioned, is displaying the most critical information all the time.

Since with medication reservoirs <NUM> according to the second to fourth preferred embodiments as shown in the <FIG> the barcode label <NUM> and the RFID/NFC label or chip <NUM> are arranged adjacent to the outlet port <NUM> and in particular on either side of the outlet port <NUM>, the barcode reader <NUM> and the RFID/NFC reader <NUM> are positioned adjacent to the inlet port <NUM> and in particular on either side of the inlet port <NUM> on the top or the upper end face 40c of the infusion pump <NUM> as shown in <FIG>. Of course, the barcode reader <NUM> is aligned in accordance with the barcode label <NUM> so as to be able to read it in a reliable manner, and the RFID/NFC reader <NUM> is positioned in an appropriate short distance from the RFID/NFC label <NUM> so as to be able to read it.

Hanging of the infusion pump <NUM> from the medication reservoir <NUM> is achieved because of its small size, so that it is hand held easily, and its weight is as low as <NUM> having huge battery autonomy for a week of infusions or <NUM> liters of volume infused being fully ambulatory. While it is so ambulatory, its functions are fully bedside, with <NUM>/h maximum infusion rate and adapted to complex "smart pump" programming using drug libraries and wireless communication and interoperability hospital infusion automation integration. Additionally the infusion pump <NUM> has dual processor safety, dual batteries and buzzers for full critical care and standard IEC60601-<NUM>-<NUM> Edition III compliance. The infusion pump <NUM> is hanging from the spike <NUM> of the drip chamber <NUM> centrally embedded in pump housing preferably and has means to keep hanging like friction from the spike or further retention by means of a grip over tubing (not shown), or a connector to the tube (connector on both the tube 26a of the outlet port <NUM> of medication reservoir <NUM> and the upper inlet of drip chamber <NUM>). For example a clip from the body of the infusion pump <NUM> that grips the tube 26a surrounding the spike <NUM> just above the connector 26b very close to the infusion pump <NUM> itself (not shown). The said clip can be snap gripping by placement, and released by single hand action which releases all this grip from reservoir and the drip chamber <NUM> and the pump cartridge <NUM> from the pump module <NUM>. The medication reservoir <NUM> comprises the connector 26b (instead of a spike-tube connection) that can hang the weight of the pump <NUM> securely, and drip chamber <NUM> has also the appropriate connector too; so the connector 26b hangs the drip chamber <NUM>, and the drip chamber <NUM> snap-fitted at the front side of the pump module <NUM> with the up-stop means <NUM> hangs the pump. The spike/tube specifications of the standard being for <NUM>,<NUM> hanging force can withstand the weight of a pump of approx. The said connector replacing a spike is standardized according to the application, as there are standards for luer connectors for intravenous, connectors for regional analgesia neuraxial NRFit, and connectors for enteral feeding in order to prevent accidental use of medications prepared for one application to another like enteral feeding delivered intravenously.

<FIG> shows the assembly or arrangement according to the embodiment of <FIG> which, however, is modified so as to be used in a piggy-back infusion configuration. In a piggy-back infusion configuration two medication reservoirs are used which are connected upstream to the infusion pump, wherein the infusion is carried out by one infusion pump from the one or the other medication reservoir depending on their height and, thus, the hydrostatic pressure of the medication. As shown in <FIG>, the tube <NUM> connecting the drip chamber <NUM> with the pump cartridge <NUM> includes a stopcock valve <NUM> to which an upstream tube <NUM> is coupled coming from another medication reservoir (not shown here). Further, the pump module <NUM> comprises a stopcock valve position detector <NUM> which is arranged close to the stopcock valve <NUM> and is adapted to detect whether the stopcock valve <NUM> in a first position connects the drip chamber <NUM> to the pump cartridge <NUM> or in a second position connects the upstream tube <NUM> to the pump cartridge <NUM>.

As mentioned above, piggyback infusions in today's practice have two reservoirs with so called primary and secondary medication upstream, connected to an Y connection, one reservoir higher than the other and so from static pressure difference, the higher is aspirated from the pump and the other is not; at some time the nurse changes the respective heights, and the other one is aspirated. Before change, the pump should be stopped and protocol changed to the other medication; it is this pump protocol change that sometimes is neglected and the pump starts with older protocol that may injure the patient.

<NUM>% medication error prevention with barcode/ RFID in piggyback infusions is achieved with the above automatic reading barcode or RFID solution on primary medication directly in vicinity to the infusion pump <NUM> and secondary medication by the upstream tube <NUM> through the stopcock valve <NUM>. So a nurse scans the barcode or RFID on both medications, plugs one direct on cartridge direct connection spike or connector so that the infusion pump <NUM> reads directly the bar-code <NUM> in horizontal position with the barcode reader <NUM> and RFID with the RFID/NFC reader <NUM> as described above, and secondary medication is connected to a normal spike or a drip chamber with spike and is infused when the stopcock valve <NUM> is turned. The <NUM>% safety is achieved because the infusion pump <NUM> knows the position of the valve <NUM> by means of the stopcock valve position reading detector <NUM> and from which of the two medications is infusing anytime because one directly read is associated with one valve position (direct), and assumes that the other (indirect) is associated with the other medication scanned but not able to be read again. In this arrangement the nurse does not need to change the respective height of the reservoirs but just the stopcock valve <NUM> so that the infusion pump <NUM> switches automatically infusion protocol to the correct medication preventing errors. The stopcock valve <NUM> can be placed on top or bottom of the drip chamber <NUM> closer to the pump, wherein in first case drugs are mixed in the drip chamber <NUM> and the infusion pump <NUM> has to be instructed what to do for few milliliters, and in second case not; both cases can have the stopcock position detector <NUM> in the pump, as an optic or magnetic or other type of sensor. Alternatively, the second medication reservoir at the end of the upstream tube <NUM> may have a device as shown in <FIG> where a flow sensor or an active valve is associated with a barcode reader <NUM> or a RFID/NFC reader <NUM> for best error prevention.

<FIG> shows an assembly or arrangement of medication reservoir, drip chamber and infusion pump which differs from the assemblies or arrangements of the <FIG> and <FIG> in that as infusion pump the miniature infusion pump <NUM> according to the first preferred embodiment of <FIG> is used and the drip chamber <NUM> is positioned above the infusion pump <NUM> and below the medication reservoir <NUM> when the whole arrangement is in an operating position as shown in <FIG>. The arrangement of the drip chamber <NUM> between the medication reservoir <NUM> and the infusion pump <NUM> results in a prolongation of the distance between the lower edge 16a of the medication reservoir <NUM> and the upper end face 2c of the infusion pump <NUM>. Different from the first preferred embodiment shown in <FIG>, but similar to the embodiments of <FIG> and <FIG>, the infusion pump <NUM> is provided in addition to the barcode reader <NUM> with the RFID/NFC reader <NUM> as wireless memory reader wherein both the barcode reader <NUM> and the RFID/NFC reader <NUM> are arranged on the upper end face 2c of the infusion pump <NUM>. As already mentioned in conjunction with the description of the first preferred embodiment, the barcode reader <NUM> is provided with a light emitting diode LED or such a LED is arranged adjacent to the barcode reader <NUM> in order to illuminate the barcode label <NUM>. Whereas the LED is not depicted here, <FIG> schematically shows the light beam 22b emitted from such a LED. The arrangement of <FIG> further differs from the arrangements of the <FIG> and <FIG> in that the RFID/NFC label or chip <NUM> is not provided at the flap <NUM>, but at the lower end of an extension <NUM> which is attached with its upper end to the flap <NUM>. Due to the provision of such an extension <NUM> it is assured that the RFID/NFC label or chip <NUM> remains positioned adjacent to the RFID/NFC reader <NUM> within the required safe distance therefrom as shown in <FIG>.

<FIG> shows an assembly or arrangement of the medication reservoir <NUM> and the infusion pump <NUM> according to a further embodiment which differs from the arrangement of <FIG> in that the infusion pump <NUM> is directly coupled so that the distance between the upper end face 2c of the infusion pump <NUM> on the one hand and the plate <NUM> and the lower edge 16a of the medication reservoir <NUM> and the tongue <NUM> with the RFID/NFC label or chip <NUM> on the other hand is about as short as in the arrangements of the <FIG> and <FIG> and, hence, the provision of an extension <NUM> as in the embodiment of <FIG> is not necessary.

The present invention provides a novel way to label medication reservoirs, so that label is always readable from a barcode and/or RFID reader of an infusion system from start to end of an infusion and warn or alarm in case of medication change without any protocol change or check.

For doing so, the label may be printed on or self-adhesive bonded to an extension of the border sealing that can bend from vertical to horizontal as an "L" i.e. by <NUM> degrees showing barcode at its bottom and securely fasten to this position by any type of fastening known in the art (not shown) or as the strip <NUM> folded as a Delta and adhesive bonded on top showing downwards the barcode label <NUM> according to the fourth embodiment of medication reservoir <NUM> as shown in <FIG>. The position of the label is such that its distance from the reader is nominal. So it can be on the border as a Δ extension below, or as a horizontal plastic clip or plate <NUM> fastened at the tube 26a of the outlet port <NUM> of the mediation reservoir <NUM> e.g. according to the second and third embodiments of <FIG> and <FIG> or on the reservoir face. The label can be add-on or printed after filling for compounding, or permanent fixture for pharmaceutical prefilled medications. This type of pharmaceutical labeling for secure infusions makes the present invention a "drug delivery" implementation when associated with infusion system devices that respond to medication error prevention needs of the busy hospitals of today as a total solution.

The said infusion safe system devices are an association of an ID reader such as a barcode or RFID or both, to one of the following: a flow sensor, a flow enabler (active valve) or an infusion pump module or whole pump. ID reader can be also an electrical (parallel bits of information) or electronic (serial bits of information) contact device (<FIG>).

In case of pump system use without lower barcode labels but conventional ones on the reservoir wall, the nurse at point of care connects the infusion set into the medication reservoir and primes it by gravity, points the pump towards patient's ID (bar-code or RFID) and reads it, then towards the medication reservoir and also reads it in case it reads bar-code, and then connects the pump on infusion set cartridge, then verifies protocol and 5R compliance. In this case, <NUM>% safety is not achieved since while it is much better than conventional pumps of today attached on pole and having long upstream tubing, because still it is difficult but possible to scan the next reservoir instead of the just above pump reservoir on which it is to be connected.

The barcode and RFID/NFC labels are automatically read at setup, at start of infusion and at time intervals during infusion. Since the barcode reader <NUM> resides on top of the infusion pump <NUM> and the infusion pump <NUM> is also in line with the drip chamber <NUM> and so in line to the label just above drip chamber in particular in both preferred embodiments of <FIG> and <FIG> as described above, in case of reservoir balancing on pole, alignment of label - tube - drip chamber - pump - barcode reader is assured and so reading is always possible and secure; it is not preferred to read label all time just for power consumption reasons except when the infusion pump <NUM> has wired or wireless power connection.

Medication delivery Safety is so absolutely <NUM>% guaranteed in case of any of RFID/NFC or bar code reading. Namely, <NUM>% safety is guaranteed in the present invention for the first time in the art, with barcode reading at start and eventually during infusion, so that the infusion pump <NUM> knows which reservoir or medication is being infused all the time so any accidental change will be discovered and alarm will be generated. For this <NUM>% medication error prevention the barcode label <NUM> on reservoir <NUM> is at specific reading distance from just below pump as shown in <FIG> and <FIG> so that the barcode shows downwards so to be read from the pump's reader regularly.

It is a practice to get a medication reservoir of <NUM> to <NUM> with just a solution of saline or dextrose and add drugs from vials. The present invention helps pharmacy automation with means to print the recipe on a barcode <NUM> and attach it to the triangle shaped label plate <NUM> as shown in <FIG> or the horizontal plate <NUM> (cf. <FIG>, <FIG> and <FIG>) fixed at the tube 26a of the medication reservoir <NUM> that will be spiked from the pump's infusion set at a specific distance range. A bar-code or QR label is printed or adhesive bonded on the plate <NUM> as shown in the <FIG>, <FIG> and <FIG> wherein a safe reading distance is taken into consideration; in case of a serial drip chamber-pump arrangement of <FIG> the reading distance is about <NUM> achievable easily from a camera based barcode reader <NUM>. The corners of the plate <NUM> at the tube 26a of the medication reservoir <NUM> are round and it may have a larger border to prevent damage of the reservoir sterile packaging.

Nurses when in a hurry today stop a pump, change the reservoir and forget to change protocol and restart the pump programmed for the former medication; with the present invention, since the pump automatically reads the nearby and accessible barcode or RFID every time before start or restart of infusion, this common error is eliminated sine an alarm will appear on medication error (wrong medication) detected.

<FIG> shows an assembly or arrangement of a medication reservoir <NUM> according to the third preferred embodiment of <FIG> and an infusion pump controller <NUM> which is used for a plurality of upstream connected infusion pump modules (not shown) or alternatively for a conventional pole-mounted bedside multi-pump with a flow sensor or active valve modules. Similar to the infusion pump <NUM> of <FIG>, the pump controller <NUM> includes the drip chamber <NUM> and the sensors <NUM>, <NUM> as already described above and is also provided with the barcode reader <NUM> and the RFID/NFC reader <NUM> on its upper end face 26a pointing to the medication reservoir <NUM>.

Each pump, flow sensor or active valve module has associated an ID reading device such as RFID, Barcode or contact electrical/electronic, and connection with a pump or pump controller. In this case, flow sensor and level detector are on the module that can also have also an active valve or infusion pump module. ID reading device together an infusion or flow sensing/enabling device at same module, assures <NUM>% safety of infusing from the correct reservoir and it is up to preparation automation to assure that each labeling medication is put in correct labeled reservoir. Namely, an infusion pump knows directly to which label is attached and infusing.

A flow sensor senses when a flow starts and pump alarms if flow and start are not synchronized therefore there is an erroneous connection (wrong medication); flow sensor has also level detector at bottom as all these three cases (pump, flow, valve) do. An active valve is closed when infusion starts, and so upstream block from pressure drop is detected, assuring that pump is connected to the correct medication reservoir, and then valve opens for infusion to start. Such a configuration is valuable for upgrading standard LVP infusion pumps or for achieving a total safety with piggyback infusions placed at the end of the upstream tube <NUM> connected to a distant medication reservoir according to the arrangement of <FIG>.

<FIG> shows a rack configuration comprising an inclined plate <NUM> which is attached to a vertical pole <NUM> and supports a plurality of assemblies or arrangements each consisting of a medication reservoir and an infusion pump. In the embodiment shown in <FIG>, the arrangements of a medication reservoir <NUM> and an infusion pump <NUM> according to the embodiment of <FIG> are provided. As shown in Fig. 12b and c, each arrangement of medication reservoir <NUM> and infusion pump <NUM> are supported by a horizontal pivot <NUM> at the plate <NUM>. As shown in Fig. 12a, the arrangements of medication reservoir <NUM> and infusion pump <NUM> and, hence, the medication reservoirs <NUM> are disposed side by side so that air contained in the medication reservoirs <NUM> can still go up. In order to achieve this effect, the inclined plate <NUM> is aligned under an angle of preferably <NUM> to <NUM>°. The rack configuration as shown in <FIG> is advantageous for mini-bags replacing syringes or syringe pump stacks in operating rooms, wherein each infusion pump <NUM> is also inclined due to a direct connection to the associated medication reservoir <NUM>. A bigger medication reservoir may hang vertically at the same level or at a higher position on the pole <NUM> along with an upstream tube connection, which all is not shown here. An easy pump handling is achieved by the horizontal pivot <NUM> which is provided at each pump location on the inclined plate <NUM>.

Claim 1:
An infusion system including
- a medication reservoir (<NUM>) having a reservoir portion (16b) for accommodating a medication and an outlet port (<NUM>) which is in fluid communication with the reservoir portion (16b) and is arranged below the reservoir portion (16b) at a lower edge (16a) of the medication reservoir (<NUM>) when the medication reservoir is in an operating position, wherein the outlet port (<NUM>) comprises a tube and a bar-code (<NUM>) is provided at the medication reservoir (<NUM>), and
- an infusion pump (<NUM>; <NUM>) comprising a display screen (8a; <NUM>) and a barcode reader (<NUM>) which is adapted to read the barcode provided at the medication reservoir (<NUM>),
characterized in that
- the barcode (<NUM>) is provided at a barcode portion of a body (<NUM>; <NUM>) facing away from the reservoir portion (16b) towards the infusion pump (<NUM>; <NUM>) connected to the outlet port (<NUM>) of the medication reservoir (<NUM>),
- the body (<NUM>; <NUM>) is arranged either (I) at the lower edge (16a) of the reservoir portion (16b) essentially in a horizontal orientation with the barcode (<NUM>) being provided at the lower side of the bar-code portion when the medication reservoir (<NUM>) is in an operating position or (II) at the outlet port (<NUM>) of the medication reservoir (<NUM>) and comprises a plate protruding from the outlet port (<NUM>) and arranged at an angle of about <NUM>° to the longitudinal direction of the tube of the outlet port (<NUM>), and
- the barcode reader (<NUM>) is arranged at the infusion pump (<NUM>; <NUM>) so that with the infusion pump (<NUM>; <NUM>) being connected to the medication reservoir (<NUM>) the reading direction of the barcode reader (<NUM>) is pointed to the barcode portion (<NUM>) of the body (<NUM>; <NUM>) and is oriented away from the display screen (8a; <NUM>) essentially in parallel with the plane of the display screen (8a; <NUM>).