Multi-state alarm method for a medical pump

Technical Field [0001] The present invention relates to a method of notification via an alarm system for use with medical application pumps for administering therapeutic fluids to a patient.

BACKGROUND OF THE INVENTION [0002] The application of therapeutic fluids to a patient is known, there are many types of medical delivery devices for delivering various therapeutic fluids, such as, for example, parenteral fluids, drugs or other medical agents, electrolytes, blood and blood preparations, and the like. One particular type of medical delivery device is an infusion pump that can deliver one or more of these therapeutic fluids to a patient through various types of administration, such as intravenous (IV), intraarterial (IA), subcutaneous, epidural, irrigation, and fluid similar. Many infusion pumps that operate under these types of administration typically use an application line set and associated container containing one or more therapeutic fluid. In the case of an infusion pump, the tubing set is usually included in a pump supply mechanism that facilitates the delivery of fluid to the patient.

[0003] Each type of application and each type of therapeutic fluid typically entails numerous operational parameters, variables, restrictions and other related information, such as medical and pharmaceutical information that requires monitoring and tracking to ensure the correct, effective and safe administration of therapeutic fluids. the patient. To ensure proper monitoring and treatment, most medical application pumps include an alarm system to indicate to the caregiver or patient that an event has occurred, for example one or more operating parameters outside of the specified range. These alarms are typically visual or acoustic alarms, such as a high simple tone alarm.

[0004] In addition to medical delivery devices, most medical equipment that is used for direct patient service typically has alarm systems to alert the caregiver about situations that require attention. However, the purpose of these devices is to notify the caregiver of such situations and enable them to remedy them, the average number of alarm systems of the equipment that can be associated with the treatment of a particular patient, and the frequency of such alarms triggered and a high level of severity of the patient's condition, ultimately minimized the importance of urgency to respond to such alarms. This can create a potentially hazardous situation especially for medical pumps used to correctly and safely administer fluids, e.g., medicines, to the patient.

[0005] US-6,554,798 describes an infusion system provided with an alarm.

[0006] US 2003/0176933 describes an implantable infusion pump provided with an alarm.

[0007] EP-A-0567945 shows a syringe pump provided with an alarm.

[0008] US-5,814,015 describes an infusion pump for at least one syringe provided with an alarm.

[0009] WO 97/21456 describes an intravenous infusion system containing an alarm.

[0010] US 2003/0114836 describes a teak delivery system provided with an alarm.

[0011] US 2003/0065370 describes an infusion pump provided with an alarm.

[0012] There is a need to distinguish between alarms, and in the case of medical pumps, there is a need to distinguish between alarms associated with the same or separate events that occur in connection with the same or separate devices.

[0013] The present invention addresses these and other problems and generally provides a new and improved method of notification by an alarm system for a medical pump for administering medicaments to a patient.

Brief description of the invention [0014] According to the present invention, a method of notification by the alarm system according to claim 1 is proposed. 1.

[0015] The alarm may be audible, the alarm may be visual, the alarm may have both a sound and visual component, the second alarm state may have a volume level that is distinguishable from the first alarm state, the second alarm state may have a tone that is distinct from the first an alarm condition, the second alarm condition may have a frequency that is distinguishable from the first alarm condition, and / or the second alarm condition may be in the form, which is distinguishable from the first alarm condition.

[0016] According to another embodiment of the invention, the second event is determined by the passage of a period of time measured from the occurrence of the first event.

[0017] According to yet another embodiment of the invention, the second event is determined by a deviation from the value assigned to at least one treatment parameter.

[0018] According to yet another embodiment of the invention, the at least one treatment parameter is associated with a pump.

[0019] According to yet another embodiment of the invention, the at least one treatment parameter is related to a source external to the pump.

[0020] According to yet another embodiment of the invention, the alarm signal associated with the alarm states is directed to the device external to the pump.

[0021] According to a further embodiment of the invention, the treatment parameter may be associated with some result of measuring the patient, pump and / or fluid.

[0022] According to yet another embodiment of the invention, the second event may be associated with a patient's life-threatening situation.

[023] According to yet another embodiment of the invention, the pump is turned off when the alarm is in the second alarm state.

[0024] According to yet another embodiment of the invention, the events can be set by the user.

[0025] According to yet another embodiment of the invention, the state of the second alarm is only triggered with a specific fluid. The identification features of this particular fluid may be stored in a pump related memory.

[0026] In accordance with yet another embodiment of the invention, the alarm system may be customized and include an approach / end approach warning / alarm function.

[0027] According to yet another embodiment of the invention, the alarm system may be incorporated into various types of infusion pumps, including a microelectromechanical system pump (MEMS).

[0028] These and other aspects of the present invention will be apparent from the drawings and description contained herein, together with the appended claims.

Brief description of the drawings [0029]

Fig. 1 is a simplified sketch generally showing an infusion pump provided with an alarm system according to the principles of the present invention.

Fig. 2 is a general simplified sketch showing an infusion pump provided with an alarm system that includes an acoustic component according to the principles of the present invention.

Fig. 3 is a view of the display screen of the infusion pump shown in Fig. 3, which shows an exemplary visual first state of the alarm system.

Fig. 4 is a view of the display screen of the infusion pump shown in Fig. 3, which shows an exemplary visual second state of the alarm system.

Fig. 5 is a simplified sketch generally showing an infusion pump provided with an alarm system communicating with at least one external device according to the principles of the present invention.

Fig. 6 is a simplified sketch of an alternative embodiment of the alarm system according to the present invention having a built-in warning / proximity alarm or time reserve function.

Fig. 7 is a simplified sketch of a specific embodiment and use of the alarm system according to the present invention.

Fig. 8 is a simplified sketch of an alternative embodiment of the alarm system according to the present invention.

Detailed Description of Preferred Embodiments [0030] Although the invention can be implemented in a variety of different forms, the drawings and the description describe the preferred embodiments in detail, understanding that the present descriptions should be considered as exemplifying the principles of the invention and are not intended to be limiting. broad aspects of the invention to the illustrated embodiments.

[0031] Fig. 1 generally shows a pump 50 for administering medical fluids having an alarm system 52 according to the principles of the present invention. As is known in the art, pump 50 is used to administer medicament 54, i.e. fluid 54, to a patient via a set of conduits 56 and an attached container 58 containing fluid 54. Preferably, pump 50 is a microprocessor pump that can be programmed using interchangeable software and / or firmware to provide operation and functions of pump 50. A preferred embodiment of popa 50 is described in US Patent Nos. 5,782,805 and 5,842,841.

[0032] The alarm system 52 comprises an alarm 60 having a first alarm condition with an assigned alarm signal (denoted by a loudspeaker icon in Figure 1 with a label "1"), and a second alarm condition with an associated alarm signal (denoted by a loudspeaker icon in Figure 1 label "2"). However, according to the principles of the present invention, any number of alarm conditions can be used with associated signals. Alarm 60 of alarm system 52 is assigned to at least one treatment parameter related to patient treatment. The treatment parameter can be assigned to pump 50, or it can be assigned to some external source that is connected to the pump alarm system 52. Examples of treatment parameters include a value representing the infusion rate of the therapeutic fluid administered to the patient by a volumetric infusion pump information related to the operation of the pump, identification of the drug administered to the patient, measurement results taken from the patient by the pump or by some external device, or any other information, or related data with patient treatment. As used herein, the term "treatment parameter" is defined to include all the parameters described above, as well as any other types or forms of data, values, parameters, information, time units or any discrete measurement or portion of data related to patient treatment. Alarm 60 can be customized and can be pre-programmed or set by a caregiver, for example at the patient's bedside.

[0033] The first alert condition is associated with the first event relating to the treatment parameter and the second alert condition is associated with the second event related to the same or different treatment parameter. The second alarm condition is distinguishable from the first alarm condition so that the caregiver can act correctly on each of the alarm conditions when they occur during treatment. Alarm 60 can be acoustic, visual or a combination thereof. Events can be any number of symptoms related to treatment, such as, for example, measurement of the time elapsed between events, measurement of treatment parameter value, symptom related to pump operation, identification or determination made by the pump or external device, etc.

[0034] In a specific embodiment, the second event may be determined by the passage of time from the activation of the first alarm condition without the caregiver attempting to handle it, the first and second events may be associated with the same treatment parameter, and the second alarm condition shall be activated only when the specific period of activation of the first alarm condition has elapsed. The second alarm state may take any form described herein, such as the increase in frequency or tone of the first alarm state.

[0035] In yet another specific embodiment, the second event may be defined by a deviation from a particular value or range of treatment parameter values. In this case, the first and second events may refer to the same treatment parameter. The first event can be determined by a first value or range of deviation from the original value of the treatment parameter, and a second value or range of deviation can be measured relative to the original value of the treatment parameter, whether programmed or obtained from an external source. In this particular case, the second alarm condition is activated relative to the original value of the treatment parameter or the first event.

[0036] In yet another embodiment, the first and second events may be associated with different treatment parameters. For example, if each event is determined by a deviation from a particular treatment parameter value, the first and second alarm states could be activated by deviation of their respective treatment parameters (i.e., first and second events). In this case, clearly distinguishable alarm states would enable the caregiver to identify a specific event related to a particular alarm condition.

[0037] It is advantageous if the second alarm condition is associated with a certain event that is critical, that is, with a threat to the patient's life or a high level of importance that requires direct attention, while the first alarm is associated with an event that is not critical, i.e. not life-threatening or of low importance, which does not require immediate attention.

However, alarm states can be tailored to or categorized for any type of event or symptom. An event can be any symptom associated with a treatment parameter, such as a deviation from a treatment parameter, or a flag raised by a treatment protocol that is triggered by that treatment parameter. Events may be associated with the application of fluid to a patient, patient measurement result, pump operation, or any other aspect of treatment. [0038] In Fig. 2, a pump 80 is shown having three sets of lines 82 attached thereto to allow three types of fluids to be administered to a patient. Preferably, the pump 80 is an infusion pump. Each of the hose sets 82 is connected to a container 83 containing fluid to be administered to a patient. The pump 80 includes a user interface 84 having a display 86 that can be used to display the visual form of the alarm 60. Although not shown, the pump may include a light indicator, e.g. an LED or other light source, and act as a visual form of alarm 60. Fig. 2 schematically shows the first acoustic alarm condition (1) and the second acoustic alarm condition (2), wherein the second alarm state is clearly distinguishable from the first alarm state because it has a higher volume than the first alarm state. Acoustic alarm states can also be distinguished by tone, by repetition frequency, by type of sound, or by any other means creating perceptually different states of these two alarm states.

[0039] As noted, the pump 80 of Fig. 2 may include a visual form of alarm 60. As an example of the visual form of alarm 60, Fig. 3 is a display screen view 86 that shows an alert that may not have a high level of validity and therefore be included in the first alarm condition. In this example, the caregiver activates the callback function related to the function of pump 80. Thus, when the secondary infusion has been completed and the pump channel has been switched to the main speed, the first alarm condition is activated in the form of an alert as shown in the screen image in Figure 3.

[0040] As an example of the visual form of the alarm 60 in the second alarm state, Fig. 4 is an image of the display screen 86 that shows an alert that can be of high importance and is therefore categorized as a knack alarm condition. In this example, pump channel 80 has failed and is not working. Since this can be critical, the second alarm condition is activated as shown in the screen image in Figure 4. It is understood that in such a case, an acoustic alarm may also be included in the alarm state.

[0041] In some cases, it may be desirable to allow the user to associate some events with a particular alarm condition. Preferably, such programming is carried out by personnel authorized by the health care unit, so that this may be in accordance with the body's policies and procedures. In a specific embodiment, the second alarm condition may be programmed to operate with a particular fluid, e.g., a particular drug. The alarm state can also be programmed to indicate the situation with drug interaction. In such embodiments, the identification of a particular fluid with an associated alarm, or tables or libraries indicating potential drug interactions, may be stored in a pump related memory.

[0042] As shown in Figure 5, according to another embodiment, the alarm system 52 and associated alarm 60 may be combined with one tube or more external sources or devices 100, so that the alarm system 52 can be used by these external sources . In this case, β

an external source or device 200 would be assigned to the treatment parameter to be monitored. For example, an alarm system 52 may be attached with a heart rate monitor or pulse oximeter, enabling the attachment of treatment parameters from these devices and events relating to treatment parameters from these devices to the alarm states of the alarm system 52. In such cases, there may be several devices or external sources that use the 52 alarm system to provide an effective multi-state alarm.

[0043] As shown in Figure 5. According to yet another embodiment, the alarm system 52 may have a connection to the device or external system 150 allowing routing of the alarm signal to the external device or system. For example, external system 150 may be a centralized server or computer that could enable alerting and associated information, such as an event, treatment parameter, device, patient identity, etc., to other devices, such as another computer , personal digital assistant (PDA), pager, wireless e-mail device, cordless telephone or computer, etc. Such a system increases the efficiency of the multi-state alarm system.

[0044] It is understood that the alarm system 52 can be customized in a variety of ways. For example, the system 52 can be set such that a certain alarm escalation is associated with the first drug, the alarm having a first state and a second state as described above. System 52 is also set such that the second drug is not associated with an alarm escalation. System 52 can also be set so that for non-critical alarms, the pump continues to operate. However, for critical alarms, the pump is switched off.

[0045] Fig. 6 is a simplified sketch of the alarm system 52 according to the present invention. In this embodiment, the alarm system 52 includes a customizable approaching warning / alarm having a built-in "time reserve" function 200, a time reserve element or a delay element. This aspect allows the user to specify or enable a second event 202 dependent on the first event 204 or dependent on when the caregiver responds to the first event 204. For example, the time reserve function 204 may determine or enable the second event 202 in terms of: the elapse of a certain period of time relative to the first event 204, or relative to when the caregiver responds to the first event 204; achieving a certain treatment parameter value relative to first event 204 or relative to when the caregiver responds to first event 204; or any type of data, information or parameters that may change with respect to the first event, or relative to when the caregiver responds to the first event 204. When the second event 202 occurs, a second alarm state 206 is activated, wherein the second alarm state 206 is distinguishable from the first alarm state 208 associated with the first event 204. The time reserve function 200 can be configured such that additional events 210, each associated with the second alarm state 208, or additional alarm states 212, which are distinguishable , can then be defined .

[0046] As already described above, according to one specific embodiment, the second event 202 may be defined in a certain amount of time that has elapsed since the first alert 208 has been activated, without the caregiver reacting to it. In the related aspect of enabling the time reserve function 200, when the caregiver responds to the first alarm condition 208, the time reserve function 200 can be included in the alarm system 52 to enable the caregiver to confirm the first event 204 and define the second event 202, in terms of to a predetermined amount of time, measured relative to either the first event 204, or from the moment when the caregiver has responded to the first events 204, i.e. a reserve interval of 214. When the caregiver is activated by the time reserve function 200, the second alarm state 206 is enabled and the second event 202 is set with the set value or pre-programmed data stored in memory, or data entered or received when activating the time reserve function 200, which represents the time reserve interval 214. After the time reserve interval 214 has elapsed, the second alarm state 206 is activated. The time reserve function 200 can be configured so that with additional activation of the time reserve function 200 additional events 210 and the associated time reserve intervals can then be defined. These additional events 210 may be associated with a second alarm state 206 or one or more additional alarm states 212. [0047] As mentioned above, in a specific embodiment, the time reserve function or time reserve element 200 may define the second event 202 in terms of the treatment parameter set value depending on the first event 204, or when the caregiver responds to the first event 204 . In a particular embodiment of this particular embodiment, the treatment parameter may be related to the infusion volume of the therapeutic agent, e.g., fluid, administered to the patient. The first event 204 can be defined in terms of time units remaining to reach the pre-determined volume level during infusion treatment of the patient. When the first event 204 occurs and the first alarm state 208 is activated, the caregiver can activate the time reserve function 200, which deactivates the first alarm state 208. In this example, activating the time reserve function 200 will cause the second event 202 to be determined or enabled in relation to value or increment of a second volume level, or in relation to time units until a certain volume level value is reached during patient treatment. When a specific value associated with the second event 202 is reached, the second alarm state 206 is activated. The time reserve function 200 can be configured so that with the additional activation of the time reserve function 200 additional events 210 can then be defined. With these additional events 210 can be associated second alarm state 206 or one or more additional alarm states 212. When the treatment parameter is related to the volume in the infusion application, these events can act as notifications to the caregiver that a specific point in infusion treatment has been reached. Notification before the end of the infusion, that is, an "near end" alert gives the caregiver the opportunity to avoid interruption in treatment, undesirable changes in the infusion rate or other phenomena that may adversely affect the patient's treatment. To avoid such phenomena, the caregiver may use the time after notification and before the end of the infusion to prepare and set up a new container or infusion set.

[0048] In a specific embodiment, the alarm system 52 remains in communication with the computer network 220 of the healthcare unit to allow communication with other devices or systems 222 within the unit. In such an embodiment, the unit's pharmacy may be automatically notified of one or more events so that a new fluid container can be prepared in time, avoiding interruption in the patient's infusion treatment. The alarm system 52 can also be in direct communication with the device or system 224, which provides various options

- 8 system control or alarm duplication, or notification within the device or system 224. In addition, the alarm system 52 can be used to infuse medicaments contained in flexible pouches, syringes or semi-rigid containers. It is further understood that the alarm system 52 may be present on an infusion device, such as an infusion pump - shown in the figures, but also on a hand-held device, a nursing notification system or a central monitoring system.

[0049] It will be appreciated that the time reserve function 200 can be implemented in a number of applications in accordance with the principles of the present invention, and descriptions in the configurations shown in Figs. 1-5 and 8. For exemplifying the specific use of this function and / or one or more aspects of the present invention, the following example is given and Figure 7 schematically illustrates some of its aspects. It should be understood that this example is one of many possible applications of the principles of the present invention and should in no way be interpreted as limiting the scope of the present invention to the details of this particular example.

EXAMPLE [0050] In this particular example, a customizable "approaching end" alarm system 250 with time reserve function 25 is provided for use in conjunction with an infusion pump used to administer a medicament or fluid to a patient by infusion. The alarm system 250 is assigned to a pump and can be incorporated into a pump, or be a separate device or system, e.g. a personal digital assistant (PDA) or other portable counting device, notification system, monitoring system or other device, network or system. The impending end alarm system 250 can be customized to infuse a particular drug, with the time reserve function 252 enabling notification of the caregiver before the infusion is complete. The notification is in the form of the first and / or second alarm status 254 and 256 of the alarm system 250, which can be either visual or both, in this case alarm states 254 and 256 notify the caregiver that the remaining infusion volume will soon reach the designated value (which in this case it is zero, although other values ​​are possible), so that the caregiver can respond to the notification, for example by suspending a new fluid container and resetting the value for infusion introduction via the pump. This prevents the infusion from dripping to a low speed, which potentially negatively affects the hemodynamic status of the patient.

[0051] In this example, the first event 260 is determined by the infusion volume reaching the first value, or parameter X, which can be pre-programmed; programmed at the point of infusion of a special drug, as in the case of bedside administration; obtained by means of identification data or data assigned to a set of wires or container, such as a barcode label, RFID, etc .; received from an external device, such as a handheld device or other external device; or received from an external source via a network connection; or the like. Alternatively, the first event 260 may be determined by a value or parameter representing a certain amount of time remaining until the end of the infusion (e.g., the number of minutes remaining to the end of the infusion). The value associated with the first event 260 can be a component of a predetermined special drug profile assigned to a container with a special drug, or to a type of tubing set. The second event 262 is also defined by the infusion volume reaching the second value, or the Y parameter, which can be programmed or received in a similar way to the first X value. If desired, additional events can also be programmed by the appropriate values.

[0052] When the first X value is reached during the infusion, the first alarm 254 is activated, causing the caregiver to be notified. The first X value could represent the 30 minutes remaining to complete the infusion. The alarm system time reserve function 252 allows the second event 262 to be set in the system, so that after the second event 254, i.e. the infusion volume reaching the second Y value, the second alarm state 262 is activated, with additional notification of the caregiver. In a preferred embodiment, the second alarm state 262 is distinguishable from the first alarm state 260, ensuring that the caregiver will be notified of the second event 254, especially in critical applications. If additional events have been programmed, the time reserve process can be continued for each of the additional events. In a specific embodiment, with only two programmable events, the first alarm state 252 and / or the second alarm state 254 is an escalating alarm which escalates as the volume value (or time value) decreases from the second value, notifying the caregiver about the speed decrease in volume (or time). Depending on the type of alarm, the escalation could be in the form of increasing the volume, changing the type of tone, changing the interval or frequency of the tone, activating or changing the appearance of one or more visual indicators, or any combination thereof. The escalation process can also be included in embodiments with more than two events and assigned alarm states. The alarm system 52 could have a more urgent (using distinguishable alerts described above) warning / approaching end alarm for designated therapies, with a high alert level or more critical.

[0053] In a specific embodiment, the alarm system 250 remains in communication with the computer network 270 of the healthcare unit, allowing communication with other systems 272 within the unit. In such an embodiment, for example, an entity's pharmacy may be automatically notified of one or more events so that a new fluid container can be prepared in time, avoiding interruption in the patient's infusion treatment.

[0054] With such alarm system functions 52, the clinician is warned that the volume to be infused will soon be zero, so that the clinician can respond to the warning, set a new container and reset the infusion volume. This prevents infusion at a speed from dripping to an undesirable low speed, and also prevents cessation of treatment. The delay or time reserve function is completely customizable, however, if required, the alarm system 52 can be configured.

[0055] Fig. 8 shows another embodiment of the alarm system according to the present invention, generally referred to as reference numeral 352. The alarm system 352 is similar to the above described embodiments, however the alarm system 352 is used with a disposable microelectromechanical element (MEMS). In one preferred embodiment, the MEMS element is a MEMS pump. It is understood, however, that the pump could be any type of single-use pump containing pumps in the form of micro-castings in plastic or otherwise manufactured on a small scale. As shown in Figure 6, the alarm system 352 can be used in conjunction with a drug delivery system, generally designated by reference numeral 300. System 100 generally includes a medical device 312, preferably a MEMS 312 pump, which may have a controller 330 connected, an application set 314 wires, container 316. System 100 may also take the form of any of the systems as described in the application belonging to the same owner U.S. Patent No. 10 / 040,887, entitled "Infusion system".

[0056] The container 316 is a container similar to the container 16 described above. In a preferred embodiment, the container 316 is a flexible bag adapted to contain a medical agent, for example a medicament or medical fluid. The set of application cables 314 is similar to the set of cables 14 described above. Cable set 314 includes a tube with one end connected or otherwise in contact with container 316 and the other end provided with a catheter or other device for communicating with the patient's body.

[0057] As it is further illustrated in Fig. 5, the MEMS 312 pump is operably connected to a line set 314. The MEMS 312 pump can be attached to a set of 314 pipes in various configurations. For example, the MEMS 312 pump may have an inlet port 320 and an outlet port 322, where the MEMS 312 pump is connected to an intermediate set of 314 lines. Accordingly, part of the line set 314 is connected to outlet port 322, the MEMS 312 pump is operably connected to the set 314 of line. When properly connected, the MEMS 312 pump can pump fluid from container 316 to the patient.

[0058] As described, the pump 312 may be a MEMS 312 pump. The MEMS components are typically etched in silicon. It is also understandable that MEMS can also mean other types of microelectromechanical system components, such as devices that are made using the micro-cast technique in plastic. Thus, MEMS elements may include a silicon etched, molded or otherwise small-scale element.

[0059] As described, system 300 may further use a controller 330. The controller 330 is operably connected to the MEMS 312 pump. The controller 330 may communicate with the MEMS 312 pump via a wireless connection. Alternatively, a line connection may be used, whereby the MEMS 312 pump can be plugged into the 330 controller. Although the controller 330 in the preferred embodiment is shown as a separate component, it is understood that the controller 330 may be integral with the MEMS 312 pump.

[0060] As in the discussion above, the controller 330 includes an alarm system 352. The alarm system 352 operates with the controller 330 and cooperates with the MEMS 312 pump. It is further understood that the alarm system 352 could be integral with the pump 312. Alarm system 352 it can be adapted to needs and may have all the characteristics of previously described alarm systems. Thus, as described, the alarm system 352 may include multiple alarm states that are distinguishable from each other. The 352 alarm system may also include an approach / end approach warning function.

[0061] It is further understood that the pump used according to the present invention may include safety software. The security software is able to generate basic fault alarms, it being assumed that the pump is not in a safe operating condition, for example, there is no free flow of the medicinal product through the pump. It is possible to use different software / pump configurations. For example, all software may be located on the pump head, or all software may be outside or remotely relative to the pump head.

In addition, all software can be located outside the pump head, except for special security software located on the pump head.

[0062] The present embodiments should therefore be considered illustrative in all respects, and the invention is not limited to the details set forth herein.