Medical fluid therapy system having multi-state alarm feature

Information

  • Patent Grant
  • 11583628
  • Patent Number
    11,583,628
  • Date Filed
    Monday, December 30, 2019
    5 years ago
  • Date Issued
    Tuesday, February 21, 2023
    a year ago
Abstract
A medical fluid therapy system having a multi-state alarm feature is disclosed. An example medical fluid therapy system includes a pumping apparatus configured to pump a medical fluid from a fluid container. The example system also includes a processor configured to generate a first alarm signal associated with a first low level event of the medical fluid in the fluid container, generate a second alarm signal associated with a second low level event of the medical fluid in the fluid container, and receive an activation of a snooze element for deactivating the first alarm signal after the first low level event has occurred and enabling the second alarm signal to be activated upon occurrence of the second low level event. The system further includes a server configured to receive and route at least one of the first alarm signal or the second alarm signal for display at a user device.
Description
TECHNICAL FIELD

The instant invention relates to alarm systems for use with medical delivery pumps for delivery of therapeutic fluids to a patient.


CROSS REFERENCE TO APPLICATIONS

This application expressly incorporates by reference, and makes a part hereof, the following U.S. patent and U.S. patent applications: U.S. Pat. Nos. 5,782,805; 5,842,841; 8,518,021; U.S. patent application Ser. No. 10/855,872; and U.S. Pat. No. 7,927,313.


BACKGROUND

The administration of therapeutic fluids to a patient is well known in the art. Many types of medical delivery devices exist to deliver various therapeutic fluids to a patient, such as, for example, parenteral fluids, drugs or other medicaments, electrolytes, blood and blood products, and the like. One particular type of medical delivery device is an infusion pump, which can deliver one or more of these therapeutic fluids to a patient via a variety of administration types, such as, for example, intravenous (IV), intra-arterial (IA), subcutaneous, epidural, irrigation of fluid spaces applications, and the like. Many infusion pumps that operate under these types of administration typically utilize an administration line set and an associated container containing one or more therapeutic fluids. The line set is typically loaded into a delivery mechanism of the pump, which facilitates delivery of the fluid to the patient.


Each type of administration and each type of therapeutic fluid typically involve numerous operational parameters, variables, constraints and other related information, such as medical and pharmaceutical related information, that must be monitored and followed to ensure proper, effective and safe delivery of therapeutic fluids to the patient and effective treatment of the patient. To ensure proper monitoring and treatment, most medical delivery pumps incorporate an alarm system to indicate to a caregiver or patient that an event has occurred, such as one or more operational parameters being out of a predetermined range. These alarms are typically visual or audible alarms, such as a beeping alarm.


In addition to medical delivery devices, most medical equipment that is utilized in direct patient care typically have alarm systems to notify the caregiver of situations that require attention. While the intent of these alarms is to notify the caregiver of such situations and allow them to be addressed, the shear number of alarm systems of equipment that may be associated with treatment of a particular patient, and the frequency of such alarms being triggered and high levels of patient acuity, have ultimately minimized the sense of urgency in responding to such alarms. This can result in a potentially dangerous situation, particularly in the case of medical pumps utilized to properly and safely deliver fluids, such as drugs, to a patient.


To address this concern, 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.


The present invention addresses these and other concerns and generally provides a new and improved alarm system for a medical pump for delivery of medicaments to a patient.


SUMMARY

The present invention generally provides an alarm system for a medical pump associated with delivering a medicament or fluid to a patient in connection with treatment of the patient. According to a particular aspect of the invention, the alarm system comprises an alarm associated with at least one treatment parameter. The alarm includes a first alarm state associated with a first event relating to the at least one treatment parameter and a second alarm state associated with a second event. The second alarm state is discernable from the first alarm state. This will allow each of the events to be treated differently by a caregiver.


According to other aspects of the invention, the alarm may be audible, the alarm may be visual, the alarm may have both audible and visual components, the second alarm state may have a tone that is discernable from the first alarm state, the second alarm state may have a volume level that is discernable from the first alarm state, the second alarm state may have a frequency that is discernable the first alarm state, and/or the second alarm state may have an appearance that is discernable from the first alarm state.


According to another aspect of the invention, the second event relates to the at least one treatment parameter.


According to yet another aspect of the invention, the second event relates to a treatment parameter different from the at least one treatment parameter.


According to yet another aspect of the invention, the second event is defined by expiration of an amount of time measured from occurrence of the first event.


According to yet another aspect of the invention, the second event is defined by a deviation from a value associated with the at least one treatment parameter.


According to yet another aspect of the invention, the at least one treatment parameter is associated with the pump.


According to yet another aspect of the invention, the at least one treatment parameter is associated with a source external to the pump.


According to yet another aspect of the invention, an alarm signal associated with the alarm states is routed to a device external to the pump.


According to a further aspect of the invention, the treatment parameter may be associated with a measurement from the patient, operation of the pump, and/or the fluid.


According to yet another aspect of the invention, the second event may be associated with a life-threatening situation for the patient.


According to yet another aspect of the invention, the pump will shut off when the alarm is in the second alarm state.


According to yet another aspect of the invention, the events can be set by a user.


According to yet another aspect of the invention, the second alarm state will only be operational with a particular fluid. The identification of the particular fluid may be stored in a memory associated with the pump.


According to yet another aspect of the invention, the alarm system can be customizable and include a near-end alert/alarm feature.


According to yet another aspect of the invention, the alarm system can be incorporated into different types of infusion pumps in including a micro electromechanical systems (MEMS) pump.


These and other aspects of the present invention will be apparent from the drawings and written specification set forth herein, including the appended claims.





BRIEF DESCRIPTION OF THE FIGURES


FIG. 1 is a schematic diagram generically depicting an infusion pump having an alarm system in accordance with the principles of the present invention.



FIG. 2 is a schematic diagram depicting an infusion pump having an alarm system that includes an audible component in accordance with the principles of the present invention.



FIG. 3 is a screen shot of a display of the infusion pump depicted in FIG. 3, which illustrates an exemplary visual first alarm state of the alarm system.



FIG. 4 is a screen shot of a display of the infusion pump depicted in FIG. 3, which illustrates an exemplary visual second alarm state of the alarm system.



FIG. 5 is a schematic diagram generically depicting an infusion pump having an alarm system in communication with at least one external device in accordance with the principles of the present invention.



FIG. 6 is a schematic diagram of an alternate embodiment of the alarm system of the present invention incorporating a near-end alert/alarm feature or snooze feature.



FIG. 7 is a schematic diagram of an example of a particular embodiment and application of the alarm system of the present invention.



FIG. 8 is a schematic diagram of an alternative embodiment of the alarm system of the present invention.





DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

While this invention is susceptible to embodiments in many different forms, there are shown in the drawings and herein described in detail, preferred embodiments of the invention with the understanding that the present disclosures are to be considered as exemplifications of the principles of the invention and are not intended to limit the broad aspects of the invention to the embodiments illustrated.



FIG. 1 generically depicts a medical fluid delivery pump 50 having an alarm system 52 in accordance with the principles of the present invention. As is well known in the art, the pump 50 is utilized to deliver a medicament 54, or fluid 54, to a patient via a line set 56 and associated container 58 containing the fluid 54. The pump 50 is preferably a microprocessor-based pump that is capable of being programmed, utilizing software and/or firmware, to facilitate operation and functionality of the pump 50. One preferred embodiment of the pump 50 is the one disclosed in U.S. Pat. Nos. 5,782,805 and 5,842,841, which are incorporated herein by reference.


In a preferred embodiment, the alarm system 52 comprises an alarm 60 having a first alarm state and associated alarm signal (indicated by the speaker icon labeled as “1” in FIG. 1) and a second alarm state and associated alarm signal (indicated by the speaker icon labeled as “2” in FIG. 1). However, any number of alarm states and associated signals could be provided in accordance with the principles of the present invention. The alarm 60 of the alarm system 52 is preferably associated with at least one treatment parameter in connection with treatment of a patient. The treatment parameter may be associated with the pump 50, or it may be associated with an external source that is in communication with the pump alarm system 52. Examples of treatment parameters may include a value representing an infusion rate of a therapeutic fluid being delivered to a patient by a volumetric infusion pump, information relating to operation of the pump, the identification of a drug being delivered to a patient, a measurement taken from a patient by the pump or an external source, or any other information or data associated with the treatment of a patient. As used herein, the term “treatment parameter” is defined to encompass all of the above-described parameters as well as any other types or forms of data, values, parameters, information, units of time, or any discrete measurement or piece of data in connection with treatment of a patient. The alarm 60 is customizable and also can be pre-programmed or set by a caregiver such as at the bedside.


According to a particular aspect of the invention, the first alarm state is preferably associated with a first event relating to a treatment parameter, and the second alarm state is associated with a second event relating to the same or another treatment parameter. The second alarm state is discernable from the first alarm state so that a caregiver can act appropriately to each of the alarm states should they occur during treatment. The alarm 60 can be audible, visual, or a combination thereof. The events may be any number of occurrences relating to the treatment of the patient, such as, for example, measurement of an elapsed time between events, measurement of a value of a treatment parameter, an occurrence relating to operation of the pump, an identification or determination made by the pump or an external device, etc.


In a particular embodiment, the second event can be defined by an amount of time that has expired since the first alarm state has been activated without being addressed by a caregiver. In such a case, the first and second events can be related to the same treatment parameter and the second alarm state is activated only when the particular amount of time has expired since activation of the first alarm state. The second alarm state may be in any form as described herein, such as, for example, an escalation of the frequency or tone of the first alarm state.


In yet another particular embodiment, the second event may be defined by a deviation from a particular value or range of values of a treatment parameter. In such a case, the first and second events can be related to the same treatment parameter. The first event may be defined by a first deviation value or range with respect to an original value of the treatment parameter and the second event may be defined by a second deviation value or range, wherein the second event may be measured with respect to either the original value of the treatment parameter or the first event. The original value may be a predetermined value, either pre-programmed or obtained by an external source. In this particular example, the second alarm state is activated only when a particular value of deviation has occurred with respect to the original value of the treatment parameter or the first event.


In yet another embodiment, the first and second events may be related to different treatment parameters. For example, if the events are each defined by a deviation from a particular value of a treatment parameter, the first and second alarm states would be activated by a deviation of its respective treatment parameters (i.e., first and second events). In such a case, the discernable alarm states would allow a caregiver to identify the particular event associated with the particular alarm state.


Preferably, the second alarm state is associated with an event that is critical, i.e., life-threatening to the patient or of a high level of importance that requires immediate attention, whereas the first alarm state is associated with an event that is non-critical, i.e., non-life-threatening to the patient or of a lower level of importance that does not require immediate attention. However, the alarm states can be customized to be associated with, or categorized by, any type of event or occurrence. The event can be any occurrence related to the treatment parameter, such as, for example, a deviation from the treatment parameter or a flag raised by a treatment protocol that is triggered by the treatment parameter. The events may be associated with administration of a fluid to a patient, a measurement from a patient, the operation of the pump, or any other aspect of treatment.


Referring to FIG. 2, a pump 80 is shown having three line sets 82 loaded therein to facilitate delivery of three fluid types to a patient. The pump 80 is preferably an infusion pump. Each of the line sets 82 is associated with a container 83 containing a fluid being delivered to the patient. The pump 80 includes a user interface 84 having a display 86 that can be utilized for displaying a visual form of the alarm 60. Although not shown, a light indicator, such as an LED or other source of light, could be incorporated into the pump and act as a visual form of the alarm 60. FIG. 2 schematically depicts a first audible alarm state (1) and a second audible alarm state (2), wherein the second alarm state is discernable from the first alarm state because it is at a higher volume level than the first alarm state. The audible alarm states can also be discernable by tone, by frequency of an interval, by type of sound, or by any other means to create a perceptively different state between the two alarm states.


As already noted, the pump 80 of FIG. 2 can also incorporate a visual form of the alarm 60. As an example of a visual form of the alarm 60, FIG. 3 depicts a screenshot of the display 86 that shows an alert that may not be of a high level of importance and is therefore categorized as a first alarm state. In this example, a caregiver enabled a callback feature relating to a piggyback function of the pump 80. Thus, when the piggyback infusion has been completed and the pump channel has switched over to the primary rate, a first alarm state is activated in the form of an alert as shown on the screenshot in FIG. 3.


As an example of a visual form of the alarm 60 in the second alarm state, FIG. 4 depicts a screenshot of the display 86 that shows an alert that may be of a high level of importance and is therefore categorized as a second alarm state. In this example, a channel of the pump 80 has failed and is out of service. Since this may be critical, a second alarm state is activated in the form shown on the screenshot in FIG. 4. It is understood that in such a case, an audible alarm may also be incorporated into the alarm state as well.


In certain instances, it may be desirable to allow a user to program certain events to be associated with a particular alarm state. Preferably such programming is done by personnel 30 authorized by a health care facility so that it can be in accordance with facility policy and procedures. In a particular embodiment, the second alarm state may be programmed to only be operational with a particular fluid, such as a particular drug. The alarm states can also be programmed to indicate drug interaction situations. In such embodiments, the identification of a particular fluid having an associated alarm, or data tables or libraries indicating potential drug interactions, can be stored in a memory associated with the pump.


As shown in FIG. 5, according to another aspect of the invention, the alarm system 52 and associated alarm 60 can be linked to one or more external sources or devices 100, such that the alarm system 52 can be utilized by these external sources. In such a case, the external source or device 100 would be associated with the treatment parameter to be monitored. For example, a heart rate monitor or a pulse oximeter may be connected to the alarm system 52 to allow treatment parameters of these devices, and events relating to the treatment parameters of these devices, to be associated with the alarm states of the alarm system 52. In such cases, there may be several external devices or sources that utilize the alarm system 52 to provide an effective multi-state alarm.


As shown in FIG. 5, according to yet another aspect of the invention, the alarm system 52 may be in communication with an external device or system 150 to allow routing of an alarm state signal to that external device or system. For example, the external system 150 may be a centralized server or computer that could allow an alarm state and associated information, such as the associated event, treatment parameter, device, patient identification, or the like, to be routed to other devices, such as another computer, a personal digital assistant (PDA), pager, wireless e-mail device, wireless telephone or communicator, or the like. Such an arrangement expands the effectiveness of a multi-state alarm system.


It is understood that the alarm system 52 is customizable in a variety of different methods. For example, the system 52 can be set such that a first drug is associated with an alarm escalation wherein the alarm has a first state and a second state as described above. The system 52 is also set such that a second drug is not associated with an alarm escalation. The system 52 can further be set such that in non-critical alarms, the pump continues to run. However, with critical alarms, the pump is shut down.



FIG. 6 discloses a schematic diagram of yet another aspect of the alarm system 52 of the present invention. In this embodiment, the alarm system 52 incorporates a customizable near-end alert/alarm having a “snooze” feature 200, snooze element or delay element. This aspect allows a user to define or enable a second event 202 relative to a first event 204 or relative to when a caregiver addresses the first event 204. For example, the snooze feature 204 may define or enable the second event 202 in terms of: expiration of an amount of time relative to either the first event 204 or when a caregiver addresses the first event 204; reaching a value of a treatment parameter relative to either the first event 204 or when a caregiver addresses the first event 204; or any other type of data, information, or parameter that may change relative to either the first event 204 or when a caregiver addresses the first event 204. When the second event 202 occurs, a second alarm state 206 is activated wherein the second alarm state 206 is discernable from a first alarm state 208 associated with the first event 204. The snooze feature 200 may be configured such that additional events 210 may be thereafter defined, each associated with the second alarm state 206, or additional alarm states 212 that are all respectively discernable.


As already discussed above, in accordance with a particular embodiment, the second event 202 can be defined by an amount of time that has expired since the first alarm state 208 has been activated without being addressed by a caregiver. In a related aspect incorporating the snooze feature 200, when the caregiver addresses the first alarm state 208, the snooze feature 200 can be incorporated into the alarm system 52 to allow the caregiver to acknowledge the first event 204 and define the second event 202 in terms of a predetermined amount of time measured relative to either the first event 204 or when the caregiver addressed the first event 204, i.e. a snooze interval 214. When the snooze feature 200 is activated by the caregiver, the second alarm state 206 is enabled and the second event 202 is set by a predetermined value or preprogrammed data stored in a memory, or by data entered or obtained at the time of activation of the snooze feature 200, which represents the snooze interval 214. After expiration of the snooze interval 214, the second alarm state 206 is activated. The snooze feature 200 may be configured such that additional events 210 and associated snooze intervals may be thereafter defined by further activation of the snooze feature 200. The second alarm state 206, or one or more additional alarm states 212, may be associated with these additional events 210.


As mentioned above, in a particular embodiment, the snooze feature or snooze element 200 may define the second event 202 in terms of a predetermined value of a treatment parameter relative to the first event 204 or when a caregiver addresses the first event 204. In a specific example of this particular embodiment, the treatment parameter may be related to the volume of an infusion of a medicament, such as a fluid, to a patient. The first event 204 may be defined in terms of a predetermined volume level value or in terms of units of time remaining until a predetermined volume level value is reached during treatment of the patient by infusion. When the first event 204 occurs and the first alarm state 208 is activated, the caregiver may activate the snooze feature 200, which deactivates the first alarm state 208. In this example, activation of the snooze feature 200 will define or enable the second event 202 in terms of a second volume level value or increment, or in terms of units of time until a volume level value is reached during the treatment of the patient. When the particular value associated with the second event 202 is reached, the second alarm state 206 is activated. The snooze feature 200 may be configured such that additional events 210 may be thereafter defined by further activation of the snooze feature 200. The second alarm state 206, or one or more additional alarm states 212, may be associated with these additional events 210. When the treatment parameter is related to the volume in an infusion application, the events can act as notifications to the caregiver that a particular point in the infusion treatment has been reached. Notification before the end of an infusion, i.e. a “near-end” alert, provides the caregiver the opportunity to avoid interruption in therapy, unwanted changes in the rate of infusion, or other occurrences that may adversely affect treatment of the patient. To avoid such occurrences, the caregiver can use the time after notification and before the end of the infusion to prepare and set-up a new container or infusion kit.


In a particular embodiment, the alarm system 52 is in communication with a computer network 220 of a healthcare facility to allow communication with other devices or systems 222 within the facility. In such an embodiment, for example, a pharmacy of the facility can be automatically notified of one or more of the events so that a new container of fluid or drug can be prepared in time to avoid an interruption in the infusion therapy of the patient. The alarm system 52 can also be in direct communication, including wireless communication, with a device or system 224 to allow for various control options of the system or alarm state duplication or notification within the device or system 224. In addition, the alarm system 52 can be utilized for infusion of medicaments contained in flexible bags, syringes or semi-rigid containers. It is further understood that the alarm system 52 can occur on an infusion device such as an infusion pump shown in the Figures, but also on a handheld device, a nurse paging system or a central monitoring system.


It should be appreciated that the snooze feature 200 can be implemented in numerous applications in accordance with the principles of the present invention, and as disclosed in the configurations shown in FIGS. 1-5 and 8. For purposes of exemplification of a particular application of this feature and/or one or more other aspects of the present invention, the following example is provided and certain aspects thereof are schematically illustrated in FIG. 7. 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 construed to limit the scope of the present invention to the details of this particular example.


Example

In this particular example, a customizable “near-end” alarm system 250 having a snooze feature 252 is provided for use in connection with an infusion pump used to deliver a medicament or fluid to a patient via infusion. The alarm system 250 is associated with the pump and can be incorporated into the pump, or a separate device or system, such as a personal digital assistant (PDA) or other portable computing device, a paging system, monitoring system, or other device, network, or system. The near-end alarm system 250 can be customizable to a specific drug infusion wherein the snooze feature 252 allows for notification to the caregiver before the end of the infusion. The notification is in the form of a first and/or a second alarm state 254 and 256 of the alarm system 250, which can be audible, visual, or both. In this example, the alarm states 254 and 256 notify the caregiver that the infusion volume remaining will soon reach a predetermined value (which is zero in this case, although other values are possible) so that the caregiver can respond to the notification, such as by hanging a new fluid container and resetting the volume to be infused via the pump. This prevents the infusion from dropping to a lower rate that could potentially adversely affect the patient's hemodynamic status.


In this example, a first event 260 is defined by the infusion volume reaching a first value or parameter X, which can be preprogrammed; programmed at the point of care for a specific drug infusion such as at the bedside; obtained via an identification or data associated with a line set or container, such as a barcode label, RFID, or the like; obtained from an external device, such as a handheld device or other external device; or obtained from an external source via a network connection; or the like. Alternatively, the first event 260 can be defined by a value or parameter representing an amount of time remaining before the end of the infusion (for example, the number of minutes remaining before the end of the infusion). The value associated with the first event 260 can be a component of a predetermined drug specific profile associated with a container of a specific drug or line set type. A second event 262 is also defined by the infusion volume reaching a second value or parameter Y, which can be programmed or obtained in similar fashion to that of the first value X. If desired, additional events defined by respective values may also be programmed.


When the first value X is reached during infusion, the first alarm state 254 is activated, thereby notifying the caregiver. The first value X could represent 30 minutes remaining before completion of the infusion. The caregiver can then activate the snooze feature. Activation of the snooze feature 252 of the alarm system 250 allows the second event 262 to be set within the system so that upon occurrence of the second event 254, i.e., the infusion volume reaching the second value Y, the second alarm state 262 is activated to further notify the caregiver. In a preferred embodiment, the second alarm state 262 is discernable from the first alarm state 260 to ensure that the caregiver will be notified of the second event 254, especially in critical applications. If additional events have been programmed, the snooze process can be continued for each of the additional events. In a particular embodiment with only two programmed events, the first alarm state 252 and/or the second alarm state 254 comprises an escalating alarm that escalates as the volume value (or time value) decreases from the second value to notify the caregiver of the rate of decreasing volume (or time). Depending on the type of alarm, the escalation could be in the form of an increase in volume, a change in the type of tone, a change in the interval or frequency of the tone, the activation of, or a change in appearance of, one or more visual indicators, or any combination thereof. This escalation process can also be incorporated in embodiments having more than two event and associated alarm states. The alarm system 52 could have a more urgent (using any of the discernable alerts described above) near-end alert/alarm for a designated high alert or in critical infusion therapies.


In a particular embodiment, the alarm system 250 is in communication with a computer network 270 of the healthcare facility to allow communication with other systems 272 within the facility. In such an embodiment, for example, a pharmacy of the facility can be automatically notified of one or more of the events so that a new container of fluid or drug can be prepared in time to avoid an interruption in the infusion therapy of the patient.


With such features of the alarm system 52, a clinician is alerted that a volume to be infused will soon be zero so the clinician can respond to the alert, set up a new container and reset the volume to be infused. This prevents an infusion from dropping to an unwanted or undesirable lower rate and also prevents an interruption of therapy. The delay or snooze feature is completely customizable wherein the alarm system 52 can be configured as desired.



FIG. 8 shows another embodiment of an alarm system of the present invention, generally designated with the reference numeral 352. The alarm system 352 is similar to the embodiments described above, however, the alarm system 352 is utilized with a disposable element or micro electromechanical system (MEMS) element. In one preferred embodiment, the MEMS element is a MEMS pump. It is understood, however, that the pump could be any type of disposable pump including pumps micro-molded in plastic or otherwise manufactured on a small scale. As shown in FIG. 6, alarm system 352 may be used in conjunction with a medication delivery system, generally designated with the reference numeral 300. The system 100 generally includes a medical device 312, preferably a MEMS pump 312, which may have an associated controller 330, an administration line set 314, a container 316. The system 100 may also take the form of any of the systems such as disclosed in commonly-owned U.S. patent application Ser. No. 10/040,887, entitled “Infusion System,” which application is expressly incorporated by reference herein.


The container 316 is a container similar to the container 16 described above. In one preferred embodiment, the container 316 is a flexible bag adapted to contain a medication such as a medicament or medical fluid. The administration line set 314 is similar the line set 14 described above. The line set 314 includes a tubing having one end connected to or otherwise in communication with the container 316 and another end having a catheter or other device for communication with the patient.


As further shown in FIG. 5, the MEMS pump 312 is operably associated with the line set 314. The MEMS pump 312 may be connected to the line set 314 in various configurations. For example, the MEMS pump 312 may have an inlet port 320 and an outlet port 322 wherein the MEMS pump 312 is connected at an intermediate portion of the line set 314. Accordingly, a portion of the line set 314 is connected to the inlet port and a portion of the line set 314 is connected to the outlet port 322 wherein the MEMS pump 312 is operably connected to the line set 314. Once properly connected, the MEMS pump 312 can pump fluid from the container 316 to the patient.


As discussed, the pump 312 may be a MEMS pump 312. MEMS devices are typically etched in silicon. It is further understood that MEMS may also describe other types of micro electromechanical system devices such as devices that are micro-molded in plastic. Thus, MEMS devices may include devices etched in silicon, molded in plastic or otherwise fabricated on a small scale.


As discussed, the system 300 may further use the controller 330. The controller 330 is operably associated with the MEMS pump 312. The controller 330 may communicate with the MEMS pump 312 via a wireless connection. Alternatively, a hard connection may be utilized wherein the MEMS pump 312 may be plugged into the controller 330. While the controller 330 is shown as a separate component in one preferred embodiment, it is understood that the controller 330 may be integral with the MEMS pump 312.


Similar to the discussion above, the controller 330 incorporates the alarm system 352. The alarm system 352 operates with the controller 330 and in cooperation with the MEMS pump 312. It is further understood that the alarm system 352 could be integral with the pump 312. The alarm system 352 is customizable and may include all of the features of the alarm systems previously described. Thus, as described, the alarm system 352 may include multiple alarm states that are discernable from one another. The alarm system 352 may also include the near-end alert/alarm feature as discussed above.


It is further understood that a pump utilized in the present invention will incorporate safety software. The safety software is capable of generating basic failure alarms wherein the pump would assume a fail safe condition such as no free flow of medicament through the pump. Various software/pump configurations may be utilized. For example, all software may be located on the pump head, or all software may be located off of, or remote from the pump head. In addition, all software may be located off of the pump head with the exception of the specific safety software being located on the pump head.


It should be understood that the invention may be embodied in other specific forms without departing from the spirit or central characteristics thereof. The present embodiments, therefore, are to be considered in all respects illustrative and not restrictive, and the invention is not to be limited to the details given herein.

Claims
  • 1. A medical fluid therapy system comprising: a medical fluid pumping apparatus configured to pump a medical fluid from a medical fluid container through a line extending from the medical fluid container;a processor including an alarm feature, the alarm feature configured to: generate a first alarm signal associated with a first low level event of the medical fluid in the medical fluid container,generate a second alarm signal associated with a second low level event of the medical fluid in the medical fluid container, andreceive an activation of a snooze element for (i) deactivating the first alarm signal after the first low level event has occurred, and (ii) enabling the second alarm signal to be activated upon occurrence of the second low level event; anda server communicatively coupled to the processor via a computer network, the server configured to: receive the first alarm signal and the second alarm signal from the processor, androute at least one of the first alarm signal and the second alarm signal for display at a user device.
  • 2. The medical fluid therapy system of claim 1, wherein the user device includes at least one of a computer, a personal digital assistant (“PDA”), a pager, a wireless e-mail device, or a wireless telephone.
  • 3. The medical fluid therapy system of claim 1, wherein the server is further configured to route at least one of the first alarm signal or the second alarm signal to a pharmacy system to prepare a second medical fluid container.
  • 4. The medical fluid therapy system of claim 1, wherein the processor and the medical fluid pumping apparatus are included within an infusion pump.
  • 5. The medical fluid therapy system of claim 1, wherein the medical fluid pumping apparatus includes at least one pump actuator configured to actuate the line to pump the medical fluid.
  • 6. The medical fluid therapy system of claim 1, wherein the first and second low level events are associated with a determined volume of the medical fluid.
  • 7. The medical fluid therapy system of claim 1, wherein the first and second low level events are associated with first and second amounts of time elapsed or remaining.
  • 8. The medical fluid therapy system of claim 1, wherein the second low level event is a duration of time that has passed since the first alarm signal associated with the first low level event is activated.
  • 9. The medical fluid therapy system of claim 1, wherein the second alarm signal is discernable from the first alarm signal.
  • 10. The medical fluid therapy system of claim 1, wherein the medical fluid pumping apparatus is an infusion pumping apparatus and the medical fluid is a parenteral fluid, a drug, a medicament, an electrolyte, or a blood or blood product.
  • 11. A medical fluid therapy system comprising: a medical fluid pumping apparatus including a pump actuator configured to pump a medical fluid from a medical fluid container through a line extending from the medical fluid container;a processor including an alarm feature, the alarm feature configured to: generate a first alarm signal associated with a first event relating to at least one treatment parameter,generate a second alarm signal associated with a second event relating to the at least one treatment parameter, andreceive an activation of a snooze element for (i) deactivating the first alarm signal after the first event has occurred, and (ii) enabling the second alarm signal to be activated upon occurrence of the second event; anda server communicatively coupled to the processor via a computer network, the server configured to: receive the first alarm signal and the second alarm signal from the processor, androute at least one of the first alarm signal and the second alarm signal for display at a user device.
  • 12. The medical fluid therapy system of claim 11, wherein the first event is associated with a value of the at least one treatment parameter, and the second event includes an expiration of an amount of time measured from an occurrence of the first event.
  • 13. The medical fluid therapy system of claim 11, wherein the first event is associated with a non-life-threatening situation concerning the at least one treatment parameter, and the second event is associated with a life-threatening situation concerning the at least one treatment parameter.
  • 14. The medical fluid therapy system of claim 11, wherein the at least one treatment parameter is indicative of an amount of the medical fluid pumped by the pump actuator.
  • 15. The medical fluid therapy system of claim 11, wherein the server is further configured to route at least one of the first alarm signal and the second alarm signal to a pharmacy system to prepare a second medical fluid container with the medical fluid.
  • 16. The medical fluid therapy system of claim 11, wherein the medical fluid pumping apparatus is an infusion pumping apparatus and the medical fluid is a parenteral fluid, a drug, a medicament, an electrolyte, or a blood or blood product.
PRIORITY

This application claims priority to and the benefit as a continuation application of U.S. patent application Ser. No. 15/935,562, filed Mar. 26, 2018, entitled “Medical Fluid Therapy System having Multi-State Alarm Feature”, now U.S. Pat. No. 10,518,030, which is a continuation application of U.S. patent application Ser. No. 14/610,035, filed Jan. 30, 2015, entitled “Multi-State Alarm System For A Medical Pump”, now U.S. Pat. No. 9,925,334, which is a continuation application of U.S. application Ser. No. 10/855,857, filed May 27, 2004, entitled “Multi-State Alarm System for a Medical Pump”, now U.S. Pat. No. 8,961,461, the entire contents of each of which is hereby incorporated by reference and relied upon.

US Referenced Citations (240)
Number Name Date Kind
3715058 Clymans Feb 1973 A
3877428 Seagle et al. Apr 1975 A
3925762 Heitlinger et al. Dec 1975 A
4028539 Jacobs Jun 1977 A
4079736 Lundquist Mar 1978 A
4180067 Derlien Dec 1979 A
4216462 McGrath et al. Aug 1980 A
4321461 Walker, Jr. et al. Mar 1982 A
4391598 Thompson Jul 1983 A
4431425 Thompson et al. Feb 1984 A
4464172 Lichtenstein Aug 1984 A
4493709 Beard et al. Jan 1985 A
4498843 Schneider et al. Feb 1985 A
4529401 Leslie et al. Jul 1985 A
4553958 LeCocq et al. Nov 1985 A
4616801 Cewers et al. Oct 1986 A
4657490 Abbott Apr 1987 A
4658375 Onogi et al. Apr 1987 A
4696671 Epstein et al. Sep 1987 A
4710166 Thompson et al. Dec 1987 A
4714462 DiDomenico Dec 1987 A
4715385 Cudahy et al. Dec 1987 A
4741736 Brown May 1988 A
4756706 Kerns Jul 1988 A
4776842 Franetzki et al. Oct 1988 A
4778449 Weber et al. Oct 1988 A
4785799 Schoon et al. Nov 1988 A
4810243 Howson Mar 1989 A
4820273 Reinicke Apr 1989 A
4828545 Epstein et al. May 1989 A
4838887 Idriss Jun 1989 A
4840542 Abbott Jun 1989 A
4842584 Pastrone Jun 1989 A
4857048 Simons et al. Aug 1989 A
4857713 Brown Aug 1989 A
4865584 Epstein et al. Sep 1989 A
4867170 Takahashi Sep 1989 A
4878175 Norden-Paul et al. Oct 1989 A
4895161 Cudahy et al. Jan 1990 A
4931050 Idriss Jun 1990 A
4943279 Samiotes et al. Jul 1990 A
4978335 Arthur, III Dec 1990 A
5002055 Merki et al. Mar 1991 A
5034004 Crankshaw Jul 1991 A
5049141 Olive Sep 1991 A
5072383 Brimm et al. Dec 1991 A
5077666 Brimm et al. Dec 1991 A
5078683 Sancoff et al. Jan 1992 A
5100380 Epstein et al. Mar 1992 A
5108367 Epstein et al. Apr 1992 A
5108372 Swenson Apr 1992 A
5205819 Ross et al. Apr 1993 A
5207666 Idriss et al. May 1993 A
5219330 Bollish et al. Jun 1993 A
5274551 Corby, Jr. Dec 1993 A
5304126 Epstein et al. Apr 1994 A
5314243 McDonald et al. May 1994 A
5317506 Coutre et al. May 1994 A
5325478 Shelton et al. Jun 1994 A
5368555 Sussman et al. Nov 1994 A
5368562 Blomquist et al. Nov 1994 A
5378231 Johnson et al. Jan 1995 A
5379333 Toth Jan 1995 A
5395340 Lee Mar 1995 A
5400378 Toth Mar 1995 A
5429602 Hauser Jul 1995 A
5445621 Poli et al. Aug 1995 A
5458123 Unger Oct 1995 A
5464392 Epstein et al. Nov 1995 A
5483957 Janssen et al. Jan 1996 A
5486286 Peterson et al. Jan 1996 A
5507412 Ebert et al. Apr 1996 A
5514088 Zakko May 1996 A
5522798 Johnson et al. Jun 1996 A
5547470 Johnson et al. Aug 1996 A
5558638 Evers et al. Sep 1996 A
5558640 Pfeiler et al. Sep 1996 A
5564803 McDonald et al. Oct 1996 A
5573506 Vasko Nov 1996 A
5586868 Lawless et al. Dec 1996 A
5591344 Kenley et al. Jan 1997 A
5628619 Wilson May 1997 A
5640953 Bishop et al. Jun 1997 A
5643212 Coutre et al. Jul 1997 A
5658250 Blomquist et al. Aug 1997 A
5681285 Ford et al. Oct 1997 A
5685844 Martila Nov 1997 A
5713856 Eggers et al. Feb 1998 A
5718562 Lawless et al. Feb 1998 A
5745378 Barker et al. Apr 1998 A
5752917 Fuchs May 1998 A
5772635 Dastur et al. Jun 1998 A
5778882 Raymond et al. Jul 1998 A
5781442 Engleson et al. Jul 1998 A
5782805 Meinzer Jul 1998 A
5791880 Wilson Aug 1998 A
5795327 Wilson et al. Aug 1998 A
5807321 Stoker et al. Sep 1998 A
5810770 Chin et al. Sep 1998 A
5814015 Gargano et al. Sep 1998 A
5816242 Cewers Oct 1998 A
5830187 Kriesel et al. Nov 1998 A
5852590 De la Huerga Dec 1998 A
5871465 Vasko Feb 1999 A
5883576 De La Huerga Mar 1999 A
5897498 Canfield, II et al. Apr 1999 A
D410081 Sweeney et al. May 1999 S
5903889 De la Huerga et al. May 1999 A
5935099 Peterson et al. Aug 1999 A
5938607 Jago et al. Aug 1999 A
5941846 Duffy et al. Aug 1999 A
5957885 Bollish et al. Sep 1999 A
5960085 De la Huerga Sep 1999 A
6012034 Hamparian et al. Jan 2000 A
6044134 De La Huerga Mar 2000 A
6045533 Kriesel et al. Apr 2000 A
6077055 Vilks Jun 2000 A
6081048 Bergmann et al. Jun 2000 A
6083206 Molko Jul 2000 A
6095985 Raymond et al. Aug 2000 A
6104941 Huey et al. Aug 2000 A
6108399 Hernandez-Guerra et al. Aug 2000 A
RE36871 Epstein et al. Sep 2000 E
6117126 Appelbaum et al. Sep 2000 A
6123686 Olsen et al. Sep 2000 A
6129702 Woias et al. Oct 2000 A
6141402 Toth Oct 2000 A
6167012 Van Den Enden et al. Dec 2000 A
6182076 Yu et al. Jan 2001 B1
6183417 Geheb et al. Feb 2001 B1
6213939 McEwen Apr 2001 B1
6216104 Moshfeghi et al. Apr 2001 B1
6231560 Bui et al. May 2001 B1
6241704 Peterson et al. Jun 2001 B1
6255951 De La Huerga Jul 2001 B1
6257936 Strandberg Jul 2001 B1
6259654 De la Huerga Jul 2001 B1
6260021 Wong et al. Jul 2001 B1
6264614 Albert et al. Jul 2001 B1
6269340 Ford et al. Jul 2001 B1
6272505 De La Huerga Aug 2001 B1
6283944 McMullen et al. Sep 2001 B1
6308171 De La Huerga Oct 2001 B1
6312227 Davis Nov 2001 B1
6342841 Sting Jan 2002 B1
6345268 de la Huerga Feb 2002 B1
6346886 de la Huerga Feb 2002 B1
6350239 Ohad et al. Feb 2002 B1
6356780 Licato et al. Mar 2002 B1
6358237 Paukovits et al. Mar 2002 B1
6362591 Moberg Mar 2002 B1
6377223 Clapp et al. Apr 2002 B1
6401138 Judge et al. Jun 2002 B1
6405165 Blum et al. Jun 2002 B1
6408330 DeLaHuerga Jun 2002 B1
6409659 Warner et al. Jun 2002 B1
6409696 Toavs et al. Jun 2002 B1
6416495 Kriesel et al. Jul 2002 B1
6434567 De La Huerga Aug 2002 B1
6450956 Rappaport et al. Sep 2002 B1
6462953 Tong et al. Oct 2002 B2
6468242 Wilson et al. Oct 2002 B1
6471645 Warkentin et al. Oct 2002 B1
6471675 Rogers et al. Oct 2002 B1
6475146 Frelburger et al. Nov 2002 B1
6475148 Jackson et al. Nov 2002 B1
6475180 Peterson et al. Nov 2002 B2
6497656 Evans et al. Dec 2002 B1
6497680 Holst et al. Dec 2002 B1
6504837 Menzel Jan 2003 B1
6506155 Sluis Jan 2003 B2
6519569 White et al. Feb 2003 B1
6520910 Kohls Feb 2003 B1
6537214 Hood et al. Mar 2003 B1
6537244 Paukovits et al. Mar 2003 B2
6539504 Knefel Mar 2003 B1
6542902 Dulong et al. Apr 2003 B2
6547748 Shine Apr 2003 B1
6551243 Bocionek et al. Apr 2003 B2
6551276 Mann et al. Apr 2003 B1
6554791 Cartledge et al. Apr 2003 B1
6554798 Mann et al. Apr 2003 B1
6562001 Lebel et al. May 2003 B2
6571128 Lebel et al. May 2003 B2
6695823 Una et al. Feb 2004 B1
6808508 Zafirelis et al. Oct 2004 B1
8961461 Stewart Feb 2015 B2
9925334 Stewart Mar 2018 B2
10518030 Stewart Dec 2019 B2
20010017817 De La Huerga Aug 2001 A1
20010025156 Bui et al. Sep 2001 A1
20010028308 De La Huerga Oct 2001 A1
20010031944 Peterson et al. Oct 2001 A1
20010037083 Hartlaub et al. Nov 2001 A1
20020002326 Causey, III et al. Jan 2002 A1
20020016568 Lebel et al. Feb 2002 A1
20020019606 Lebel et al. Feb 2002 A1
20020029776 Blomquist Mar 2002 A1
20020038392 De La Huerga Mar 2002 A1
20020058906 Lebel et al. May 2002 A1
20020061255 Nguyen et al. May 2002 A1
20020065454 Lebel et al. May 2002 A1
20020065509 Lebel et al. May 2002 A1
20020065540 Lebel et al. May 2002 A1
20020072733 Flaherty Jun 2002 A1
20020077852 Ford et al. Jun 2002 A1
20020077865 Sullivan Jun 2002 A1
20020087120 Rogers et al. Jul 2002 A1
20020107476 Mann et al. Aug 2002 A1
20020116509 De La Huerga Aug 2002 A1
20020123740 Flaherty et al. Sep 2002 A1
20020126035 Hou Sep 2002 A1
20020151875 Haller Oct 2002 A1
20020156462 Stultz Oct 2002 A1
20020198513 Lebel et al. Dec 2002 A1
20030036783 Bauhahn et al. Feb 2003 A1
20030040722 Massengale et al. Feb 2003 A1
20030050621 Lebel et al. Mar 2003 A1
20030055406 Lebel et al. Mar 2003 A1
20030055570 Ribeiro, Jr. Mar 2003 A1
20030060753 Starkweather et al. Mar 2003 A1
20030060765 Campbell et al. Mar 2003 A1
20030065308 Lebel et al. Apr 2003 A1
20030065370 Lebel et al. Apr 2003 A1
20030100864 Bendsen et al. May 2003 A1
20030114836 Estes et al. Jun 2003 A1
20030125612 Fox et al. Jul 2003 A1
20030128126 Burbank et al. Jul 2003 A1
20030135087 Hickle et al. Jul 2003 A1
20030139701 White et al. Jul 2003 A1
20030163088 Blomquist Aug 2003 A1
20030163223 Blomquist Aug 2003 A1
20030163789 Blomquist Aug 2003 A1
20030167035 Flaherty et al. Sep 2003 A1
20030176933 Lebel et al. Sep 2003 A1
20030181851 Mann et al. Sep 2003 A1
20030181852 Mann et al. Sep 2003 A1
20030191431 Mann et al. Oct 2003 A1
20040078231 Wilkes et al. Apr 2004 A1
20040172222 Simpson Sep 2004 A1
Foreign Referenced Citations (14)
Number Date Country
1327309 Dec 2001 CN
0567945 Nov 1993 EP
0829266 Mar 1998 EP
1703839 Sep 2006 EP
3-140164 Jun 1991 JP
2003-25176 Jan 2003 JP
2003-70803 Mar 2003 JP
9523620 Sep 1995 WO
9721456 Jun 1997 WO
0028127 May 2000 WO
0028217 May 2000 WO
02066101 Aug 2002 WO
03022127 Mar 2003 WO
03058567 Jul 2003 WO
Non-Patent Literature Citations (13)
Entry
Communication from Lorenz Siedler-Gossel to the EPO dated Mar. B, 2012 regarding Opposition against European Patent EP 2060285 81 (27 pages).
English Translation of Communication from Lorenz Siedler-Gossel to the EPO dated Mar. B, 2012 regarding Opposition against European Patent EP 2060285 81 (24 pages).
Reply of the patent proprietor to the notice(s) of opposition dated May 10, 2013 relating to EP09075083.7.
Annex to communication—opposition dated Mar. 20, 2015 relating to EP09075083.7.
Letter dated Mar. 11, 2016 from Potter Clarkson on behalf of proprietor and appellant Baxter International Inc.regarding the opposition procedure (no time limit) and accompanying auxiliary requests No. 1-12 relating to EP09075083.7.
Decision revoking the European Patent No. EP-B-2 060 285 dated Jun. 23, 2016 relating to EP09075083.7.
Notice of Appeal dated Jul. 22, 2016 and accompanying letter and claims on behalf of proprietor and appellant Baxter International Inc. relating to EP09075083.7.
Grounds of Appeal, accompanying letter and claim requests on behalf of proprietor and appellant Baxter International Inc. dated Oct. 21, 2016 relating to EP09075083.7.
Communication from Lorenz Seidler Gossel dated Feb. 23, 2017 submitting Reply to Appeal on behalf of Opponents and Respondents Fresenius Deutschland GmbH and Fresenius Medical Care Deutschland GmbH relating to EP09075083.7.
Communication from Maikowski & Ninnemann dated Mar. 3, 2017 submitting Reply to Appeal on behalf of Opponents and Respondents Fresenius Deutschland GmbH and Fresenius Medical Care Deutschland GmbH relating to EP09075083.7.
International Preliminary Report on Patentability—PCT/US2005/013283—dated Nov. 29, 2006—1 page.
Written Opinion of the International Searching Authority—PCT/US2005/013283—dated Aug. 1, 2005—6 pages.
International Search Report—PCT/US2005/013283—dated Aug. 1, 2005—6 pages.
Related Publications (1)
Number Date Country
20200129693 A1 Apr 2020 US
Continuations (3)
Number Date Country
Parent 15935562 Mar 2018 US
Child 16730311 US
Parent 14610035 Jan 2015 US
Child 15935562 US
Parent 10855857 May 2004 US
Child 14610035 US