Infusion system and pump with configurable closed loop delivery rate catch-up

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DESCRIPTION

Infusion set and pump with configurable closed loop delivery rate recovery

Technical field

The present invention relates to medical devices. More specifically, the invention relates to infusion systems and pumps with configurable closed loop delivery rate recovery.

Background of the invention

Infusion pumps are medical devices that deliver fluids, including nutrients and drugs such as antibiotics, chemotherapy drugs, and pain relievers, to a patient's body in controlled amounts. Many types of pumps, including high-volume, patient-controlled analgesia (PCA), elastomeric, syringe, enteral, and insulin pumps, are used throughout the world in healthcare facilities such as hospitals and at home. Doctors and patients rely on pumps for the safe and accurate delivery of fluids and medications.

Currently available infusion pumps use an open-loop pumping rate: the desired pump or volumetric flow rate is entered directly, or is calculated from an entered volume to be infused and the period or duration of delivery, and the rate pump. Infusion operates at a single target motor stroke speed or frequency to deliver the desired flow or pump regardless of external conditions. Unfortunately, the flow supply can be interrupted by a variety of conditions, such as an interruption or pause due to a partial or total occlusion, a kinked tube, an air-in-line alarm, hanging a new IV bag, a vein clot. or something similar. Once the flow delivery is interrupted, the time when there is no drug delivery is lost, causing a delay in the completion of the desired infusion.

Nurses often work in shifts and wait for certain medications to start and / or end within their shift and schedule accordingly. When occlusions, pauses, or other disturbances interrupt or delay drug delivery, this disrupts nurses' planning for patient care within their respective shifts. Furthermore, patients in these scenarios would not receive the required medicine within the allotted time.

US 5,522,798 describes a host controller for controlling drug concentrations for each of a plurality of channels delivered through multiple drug channels of a multichannel drug delivery system. The host controller includes a controller that couples to each drug channel of the multichannel drug delivery system to receive actual drug delivery rate information.

US 4,525,163 describes a controller for intravenous equipment that operates both to maintain the instantaneous drip rate through a drip chamber included in IV equipment at a desired value, and to modify this value repeatedly during the course of an infusion. The desired drip value is modified based on the volumetric flow rate measured through the IV set so that if a particular infusion fluid causes abnormally small volume drops in the drip chamber, then the controller automatically increases the drip rate to compensate .

US 2006/0270971 describes a hydration system for patients that includes an infusion device for delivering hydration fluid to a patient and a device for measuring patient urine output. If an interruption is detected, a controller software calculates the amount of urine produced by a patient during the interruption using weight measurements, and the system increases the infusion rate.

Document US 2002/0077852 describes a system for creating a personalized drug library for a drug infusion pump that can be loaded electronically, the system includes a drug library containing a plurality of drug entries, being associated with each entry Drug Delivery a set of associated drug delivery parameters and / or drug delivery protocols to configure the drug infusion pump.

Document US 2006/0064053 describes an infusion system comprising a first pump device supplying a first infused fluid to an intravenous infusion line and a second pump device supplying a second infused fluid to the IV line. A metering device determines the amount of first non-delivered infused fluid remaining in a receptacle. A control system communicates with the first and second delivery devices and the metering device to determine an optimal infusion rate of first infused fluid based on the determined amount of non-delivered first infused fluid remaining in the system, a predetermined volume. of fluid to be infused and a predetermined infusion time period.

It would be desirable to have an infusion set and pump with a configurable closed loop delivery rate recovery that overcomes the above disadvantages.

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Compendium of the invention

The scope of the invention is defined by the appended claims. Embodiments and examples that do not fall within the scope of the claims are for reference only.

Other features and advantages of the invention will become more apparent from the following detailed description of the presently preferred embodiments, read in conjunction with the accompanying drawings. The detailed description and drawings are merely illustrative of the invention rather than limiting, the scope of the invention being defined by the appended claims.

Brief description of the drawings

Figure 1 is a schematic diagram of the drug management system including a drug management unit and a medical device integrated with other systems in a hospital environment, in accordance with the present invention;

Figure 2 is a schematic diagram of the drug management unit, according to the present invention;

Figure 3 is a schematic diagram of some of the main functions performed by the drug management unit, according to the present invention;

Figure 4 is a schematic diagram of a medical device, according to the present invention;

Figures 5A and 5B are perspective views of a multi-channel medical device, according to the present invention;

Figures 6A and 6B are screenshots of a graphical user interface and details of the graphical user interface, respectively, for configuring a drug library, in accordance with the present invention;

Figure 7 is a graph of an infusion volume and infusion rate versus time modeled for an infusion with an infusion pump employing configurable closed-loop delivery rate capacity, in accordance with the present invention;

Figure 8 is a block diagram of a control model for an infusion pump employing configurable closed loop delivery rate recovery, in accordance with the present invention;

Figure 9 is a flow chart of a method for configuring a drug library for use with an infusion system employing configurable closed loop delivery rate recovery in accordance with the present invention; Y

Figure 10 is a flow chart of a method of operating an infusion pump employing configurable closed loop delivery rate recovery in accordance with the present invention.

Detailed Description of Currently Preferred Embodiments

Figure 1 is a schematic diagram of the drug management system including a drug management unit and a medical device integrated with an information system, according to the present invention. The drug management system (MMS) 10 includes a drug management unit (MMU) 12 and a medical device 14, which normally operates in a hospital environment 16. The term hospital setting, as defined herein, is widely used to refer to any health care facility, including but not limited to a hospital, treatment center, clinic, doctor's office, day surgery center, hospice, home elderly and any of the above associated with a home care setting. There can be a variety of information systems in a hospital setting. As shown in Figure 1, the MMU 12 communicates with a hospital information system (HIS) 18 through a caching mechanism 20 that is part of the hospital environment 16.

Those skilled in the art will appreciate that the caching mechanism 20 is primarily a pass-through device to facilitate communication with the HIS 18 and its functions can be removed or incorporated into the MMU 12 (Figure 1) and / or the medical device. 14 and / or the HIS 18 and / or other information systems or components within the hospital environment 16. Caching mechanism 20 provides temporary storage of hospital information data separate from HIS 18, Medication Administration Record System (MAR) 22, Pharmacy Information System (PhIS) 24, Facultative Order Entry (POE) ) 26, and / or laboratory system 28. The caching mechanism 20 provides accessible information storage for the drug management system 10 to support scenarios where direct access to data within the hospital environment 16 is not available or desired. In one example, the caching mechanism 20 provides a continuous flow of information in and out of the MMU 12 in cases where the HIS 18 is idle or the connectivity between the MMU 12 and the electronic network (not shown) is inactive.

The HIS 18 communicates with a Medication Administration Record System (MAR) 22 to maintain medication records and a Pharmacy Information System (PhIS) 24 to dispense prescription prescriptions.

ES 2 839 092 T3 drugs to HIS. A practitioner / provider order entry (POE) device 26 enables a healthcare provider to supply a prescription prescribed for a patient to the hospital information system directly or indirectly through the PhIS 24. An expert in the art also You will appreciate that a prescription can be sent to the MMU 12 directly from the PhIS 24 or POE device 26. As used herein, the term prescription is defined as an order to administer something that has a physiological impact on a person or animal, including, but not limited to, liquid or gaseous fluids, drugs or medicines, liquid nutritional products, and combinations of the same.

Laboratory system 28 and monitoring device 30 also communicate with MMU 12 to provide updated patient-specific information to MMU 12. As shown, MMU 12 communicates directly with laboratory system 28 and the monitoring device. monitoring 30. However, those skilled in the art will appreciate that the MMU 12 may communicate with the laboratory system 28 and the monitoring device 30 indirectly through the HIS 18, the caching mechanism 20, the medical device 14, or some other device. or intermediary system.

The supply information input device 32 also communicates with the MMU 12 to aid in the processing of drug prescriptions for delivery through the MMU 12. The supply information input device 32 can be any type of data input medium, including those adapted to read machine-readable indications such as barcode labels; for example, a personal digital assistant (PDA) with a barcode scanner. Hereinafter, the supply information input device 32 is referred to as the input device 32. Alternatively, the machine-readable indications may be in other known forms, such as radio frequency identification (RFID) tag, two-dimensional barcode, identification matrix, transmitted radio identification code, human biometric data such as fingerprints, etc. and the input device 32 adapted to read or recognize such indications. Input device 32 is shown as a separate device from medical device 14; alternatively, the input device 32 communicates directly with the medical device 14 or may be fully or partially integrated with the medical device.

Figure 2 is a schematic diagram of the drug management unit, according to the present invention. The drug management unit 12 includes a network interface 34 for connecting the MMU 12 to multiple components of a hospital environment 16, one or more medical devices 14, and any other device or network that is desired. A processing unit 36 ​​is included in the MMU 12 and performs various operations that are described in greater detail below. A display / input device or user interface 38 communicates with processing unit 36 ​​and enables the user to receive output from processing unit 36 ​​and / or information input to processing unit 36. Those skilled in the art They will appreciate that the exposure / input device 38 can be provided as a separate exposure device and a separate input device.

An electronic storage medium 40 communicates with the processing unit 36 ​​and stores programming code and data necessary for the processing unit 36 ​​to perform the functions of the MMU 12. More specifically, storage medium 40 stores multiple programs formed in accordance with the present invention for various functions of MMU 12 including, but not limited to, the following programs: Maintain Drug Library 42; Download Drug Library 44; Processing drug prescription 46; Maintain Expert Clinical Rules 48; Apply Expert Clinical Rules 50; Monitor Pumps 52; Monitor Lines 54; Generate Reports 56; See Data 58; Configure the MMS 60; and Monitor the MMS 62. The Maintain Drug Library program 42 creates, updates and deletes drug entries and establishes a current active drug library. The Download Drug Library program 44 updates medical devices 14 with the current drug library. The Process Drug Prescription program 46 processes a patient's prescription, verifying that the medication at the point of care (POC) and delivery parameters match those ordered. The Maintain Expert Clinical Rules program 48 creates, updates, and removes rules that describe therapy and hospital protocol regimens. The Apply Expert Clinical Rules 50 program performs logical processing to ensure safety and considers other infusions or prescriptions, patient demographics, and current patient conditions. The Monitor Pumps 52 program acquires ongoing updates of status events and alarms transmitted in near real time and in batch mode, in addition to tracking location, current assignment, and software versions, such as the version of the drug library that resides in the medical device. 14. The Monitor Lines 54 program acquires ongoing status, event, and alarm updates for each channel or line of a medical device 14 that supports multiple lines or channels of medication delivery. The Generate Reports program 56 provides a mechanism that allows the user to generate various reports from the data stored on the MMU storage medium 40. The View Data program 58 provides a mechanism that supports various display or display capabilities for users of the MMU 12. The Notifications program 59 provides a mechanism for scheduling and supplying events to external users and systems. The Configure MMS 60 program provides a mechanism for system administrators to install and configure MMS 10. The Monitor MMS 62 program enables IT operations personnel capabilities to view the current status of MMS 10 components and processing, and other aspects of daily operations such as startup, shutdown, backup and system restore.

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Figure 3 is a schematic diagram of some of the main functions performed by the drug management unit, according to the present invention. The various functional programs 42-62 of the MMU 12, each of which includes independent functions and rules, are divided (at a higher level than shown in Figure 2) and logically organized into interrelated management units of the MMU 12. As shown, the MMU 12 includes an asset manager 64, an alarm manager 66, a drug library manager (as, for example, is included in the HOSPIRA MEDNET ™ software) 68, a caregiver manager 70, a therapy manager 72 and / or clinical data manager 73. However, those skilled in the art will appreciate that additional or alternative hospital systems management units can be provided without departing from the present invention. Furthermore, the MMU 12 includes a master mediator 74 between the independent and interrelated management units 64-73 of the MMU 12, regulating the interaction between the independent management units.

Furthermore, while the MMU 12 as described in this document appears as a single device, there may be more than one MMU 12 operating harmoniously and sharing the same database. For example, the MMU 12 may consist of a collection of MMU-specific applications that run on different servers to avoid a single point of failure, address availability requirements, and handle a large volume of requests. In this example, each individual server part of MMU 12 operates in conjunction with other server parts of MMU 12 to redirect service requests to another server part of MMU 12. In addition, master mediator 74 allocates requests for services redirected to another part of the MMU server 12, prioritizing each request and also ensuring that each request is processed.

With reference to Figures 2 and 3, each of the management units 64-72 includes independent features and rules to govern its operation. For example, asset manager 64 governs the execution of the Monitor Pumps 52 and Monitor Lines 54 programs; the drug library manager 68 governs the execution of the programs Maintain Drug Library 42 and Download Drug Library 44; the therapy manager 72 governs the execution of the programs Process Drug Order 46, Maintain Expert Clinical Rules 48, and Apply Expert Clinical Rules 50; and the clinical data manager 73 governs the execution of the Generate Reports 56 and View Data 58 programs. According to the present invention, another distribution of the functional MMU programs 42-62 can be made between the manager units 64-73.

Figure 4 is a schematic diagram of a medical device, according to the present invention. An electronic network 114 connects the MMU 12, the medical device 14, and the hospital environment 16 for electronic communication. Electronic network 114 may be a completely wireless network, a fully wired network, or some combination thereof. As used herein, the term "medical device" includes, without limitation, a device that acts on a cassette, reservoir, vial, syringe, or tube to transport medication or fluids to or from a patient (e.g., an enteral pump, a parenteral infusion pump, a patient-controlled pain management or analgesia (PCA) medication pump, or a suction pump), a monitor to monitor the patient's vital signs or other parameters, or a diagnostic, testing or sampling device.

The pump style medical device 14 includes a network interface 112 for connecting the medical device 14 to the electronic network 114. Where a wireless connection to the electronic network 114 is desired, the network interface 112 uses an antenna for wireless connection to the electronic network. electronic network 114. The antenna may protrude outside of medical device 14 or be enclosed within the housing of the device.

A processor 118 is included in the medical device 14, includes a real-time clock (not shown), and performs various operations described in greater detail below. The input / output device 120 allows the user to receive the output from the medical device 14 and / or enter information into the medical device 14.

Those skilled in the art will appreciate that the input / output device 120 can be provided as a single device, such as a touch screen 122, or as a separate exposure device and a separate input device (not shown). In one embodiment, the display 122 of the medical device 14 is a thin film transistor active matrix color liquid crystal display with a multi-wire touch screen. A generally fluid impermeable membrane is superimposed on the exposure screen 122 so that the user can press images of keys or buttons on the underlying screen with wet gloves, dry gloves, or without gloves to activate an input.

A memory 124 communicates with processor 118 and stores the code and data necessary for processor 118 to perform the functions of medical device 14. More specifically, memory 124 stores multiple programs formed in accordance with the present invention for various functions of medical device 14 including a graphical user interface program 126 with multiple subparts described in greater detail below.

Figures 5A and 5B are perspective views of a multichannel medical device in communication with a machine-readable input device, in accordance with the present invention. Figure 5A illustrates an infusion pump with a divided exposure screen, having a part associated with each channel. Figure 5B illustrates an infusion pump with an exposure screen for receiving a programmable infusion input from a user. Medical device 14 in this example is a multichannel infusion pump. Those skilled in the art will appreciate that medical device 14 can be a single-channel infusion pump, a multi-channel infusion pump (as shown), a combination thereof, or the like, as desired for a particular application.

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Referring to Figure 5A, medical device 14 provides a machine-readable input device 130. Machine-readable input device 130 communicates with medical device 14 to input machine-readable information into medical device 14. The device Machine-readable input device 130 can communicate, directly or indirectly, with medical device 14 via a wireless or wired connection. The machine-readable input device 130 can be a device that is separate from but associated with or in communication with the medical device 14. The machine-readable input device 130 can be any type of data input medium, including those adapted to read Machine-readable prompts such as a barcode scanner or handheld personal digital assistant (PDA). Alternatively, machine-readable input device 130 may function to read other known forms of machine-readable information, such as radio frequency identification (RFID) tags, touch memory, digital photography, biometrics, etc.

The medical device 14 is a multichannel pump having a first channel 132 with a first machine-readable channel label 134 and a second channel 136 with a second machine-readable channel label 138. A user of the medical device 14 uses the input device machine readable 130 to select a channel from one or more channels 132 and 136, scanning the associated machine readable label 134 or 138.

User selects desired channel 132 or 136 by using machine-readable input device 130 to scan a unique, machine-readable, factory or hospital programmed label 134 or 138 that is electronically generated and displayed on screen 122 , preferably positioned near the respective channel 132 or 136. Alternatively, machine readable labels 134 and 138 are physically affixed to medical device 14, preferably on or positioned near channel 132 and 136, respectively. Since machine readable labels 134 and 138 are generated and / or stored in memory 124 by medical device 14, medical device 14 can associate machine readable labels 134 and 138 with channels 132 or 136. Medical device 14 then allows the user to program and activate the selected channel 132 or 136. The user can also manually select the desired channel by touching an appropriate folder tab on the touch screen. The folder tabs are labeled and / or physically arranged on the screen so that they are close to the corresponding channel 132 or 136.

In a further aspect of the wireless embodiment, all medical devices may periodically broadcast a unique wireless device / channel IP address and / or a unique machine-readable self-generated label (eg, a barcode) 134 or 138 that is also may be displayed on screen 122. Alternatively, machine readable labels 134 and 138 are physically affixed or posted on medical device 14. Each medical device will map such broadcast or published device / channel IP addresses and / or barcodes to a particular patient, which is also identified by a unique machine-readable label (not shown) or IP address of the patient. The user associates the desired pump (s) or channel (s) 132, 136 with the patient using the machine-readable input device 130 to scan the unique machine-readable labels 134, 138 and the readable label. by patient machine. This causes the appropriate pump processor (s) 118 to associate the appropriate pump channel (s) 132, 136 with the patient. The pumps or channels can then associate, communicate and coordinate with each other wirelessly.

The graphical user interface program remaps screen 122 for medical device 14. Specifically, Figure 5A illustrates a multi-channel medical infusion device 14 with a split touch screen 122 having a first channel screen portion 140 associated with the first channel 132 and a second channel screen portion 142 associated with second channel 136. Each channel screen portion 140 and 142 presents a subset of the delivery information regarding the respective channels 132 or 136 including, without limitation, the therapeutic agent name, concentration, dose rate, VTBI, and information. alarm, in a font size that the user can easily read from a distance, such as approximately fifteen to twenty feet (4.6-6.2 meters) away. This is what is defined here as a far-view supply screen. The far view supply exposure screens display subsets of the information found on the relevant near view supply displays. The close-up supply screen displays information such as drug name, concentration, dose rate, time remaining, VTBI, volume remaining, and alarm name for the highest priority alarm if in a state alarm.

In practice, the supply screen shows a close-up view when the user is programming the device as illustrated in Figure 5B. The near view delivery screen will change to the far view delivery screen after a predetermined period of time that is predetermined by the manufacturer, configurable by the facility through the drug library, and / or set by the caregiver in the pump, for example after 20 seconds. Often times, the user does not want to wait the predetermined period of time to view the distant screen.

Returning to FIG. 5A, the selected channel screen portion 140 or 142 or corresponding to the selected tab is expanded in the area, but the size of at least part of the text therein is reduced. The contraction of one of the channel display portions 140 and 142 and the enlargement of its counterpart provides additional space to place one or more data entry or data display fields on the display 122, as shown in Figure 5B. . As explained below, on screen 122 data entry or data display fields are placed in the space previously occupied by portions of the channel screen portion 140 or 142. This reallocation of space on screen 122 allows the user to enter entries more easily as the input field

The data input may be large, preferably at least as large or, more preferably, larger in area than the original channel screen portions 140 and 142 were in the supply screen mode. In addition, reallocating screen space 122 provides more space to present information about the channel being adjusted or monitored.

Referring again to FIG. 5A, medical device 14 includes fixed or dedicated touch infuser buttons and button images on LCD touch screen 122. The fixed touch buttons 133, 135, 137 and 139 provide the following functions: LOAD / EJECT button 133 - opens and closes the cassette carriage; the on / off button 135 - turns on and off; ALARM SILENCE button 137 - silences a silenceable alarm for a specified period of time, for example, two minutes; y THE EMERGENCY STOP button 139 stops all channels. The color LCD touch screen 122 allows the user to access and use on-screen button images, such as 3D button images and data entry fields. The touch screen 122 uses a membrane on the LCD screen so that a single keystroke does not cause significant movement of the infusion post or is confused with a double keystroke. The touchscreen also supports a keystroke, whether the user is wearing wet gloves, dry gloves, or no gloves.

The LCD touch screen button images 143, 145, 147, and 149A-149E found as shown in Figures 5A and 5B perform the following functions: Patient Information Tab 143: displays the clinical care area, information of the preselected patient (including but not limited to name, ID number, etc.) and provides access to a more detailed patient information screen; Channel 145 Level Therapy Buttons - accessed via button images on the infuser touch screen, used to select an infusion therapy; Program Level Buttons 147 - accessed by pressing areas, drop-down list triangles, boxes or text boxes on the programming screen, are used to select the dose parameters of an infusion; y Device Level Buttons 149A-149E at the bottom of the touch screen are used to display and control device-level functions, including but not limited to Mode 149A (e.g., operational or biomedical), 149B registers, 149C locks, 149D settings, and 149E calculator display. A wireless indicator image 102 displayed at the bottom of screen 122 indicates that medical device 14 is connected and ready for communication.

Using Channel Level Therapy Buttons 145 and Program Level Buttons 147, the healthcare professional can program each individual channel of the pump with specific fluid therapies in a variety of units based on weight and body surface area. , as micrograms / kg / hour, grams / m²/ hr, and other delivery specifications for the following modes: Basic Therapy - Includes dose calculation, allowing dose rate programming based on volume to be infused (VTBI), drug quantity, infusion time, and drug concentration and a simple rate programming that allows programming of the volumetric rate (ml / h) based on VTBI and time; Bolus Delivery - allows the user to program a single uninterrupted discrete delivery based on the number of doses and time (bolus can be delivered from either the primary or secondary container); Supplemental Delivery - allows the user to schedule the delivery of a secondary infusion, which will be delivered through the same cassette as the primary infusion (the primary infusion is paused until the supplemental VTBI is completed); and Advanced Programming. Advanced programming mode provides a variety of program types, including: Multi-Step - Enabling sequential fluid delivery in up to 10 steps, with programmable fluid volumes and delivery rates for each step based on rate and volume or the volume and time; Variable time: allowing up to 24 dose calculation steps at specific clock times; Intermittent - a calculated dose or step to be delivered at regular intervals; and Declining: a supply that increases and / or falls at a plateau rate.

Referring to Figures 4 and 5A, graphical user interface 126 provides channel indicators displayed on display 122. Channel indicators associate on-screen programming, delivery, and alarm information with a particular delivery channel via the use of graphical representations, such as a channel indication icon 154, 155. Channel indication icon 154 or 155 is a graphical element that clearly associates on-screen alarm, supply, and schedule information with a specific associated supply channel. Channel indication icons 154 and 155 are located on a tab 158 associated with a specified delivery channel of the medical device. Channel indication icon 154 or 155 may include, but is not limited to, a user-readable letter or number, a machine-readable indicator 134, or a combination thereof. The graphical user interface program 126 also provides a drip indicator icon 160 and an infusion status icon 156 displayed on screen 122.

Referring to FIG. 5B, screen 122 provides an optional drop down box 170 for setting an Allow Rate Recovery flag to one of Enable settings and Disable settings on the pump. Drop-down box 170 allows the user to enable or disable the rate recovery function and override the predetermined rate recovery flag provided in the drug library, if desired. When the Allow rate recovery flag is set to the Enable setting, the user can enter a recovery rate factor in the recovery rate factor value box 172. In this example, screen 122 also shows a limit value recovery rate factor 174 and a recovery rate factor alarm value 176 provided through the drug library. The recovery rate factor limit value 174 is the maximum recovery rate factor that the user can enter in the recovery rate factor value box 172, that is, the maximum recovery rate factor or hard limit.

ES 2 839 092 T3 allowed for the particular therapeutic agent. The recovery rate factor alarm value 176 is a soft limit on the recovery rate factor. In one example, screen 122 will provide an alarm when the user enters a value in the recovery rate factor value box 172 that exceeds the recovery rate factor alarm value 176, but the infusion pump will accept the recovery rate factor after the user acknowledges the alarm or indicates a decision to override the soft limit as long as the recovery rate factor does not exceed the hard limit or the rate factor limit value recovery 174. Those skilled in the art will appreciate that the recovery rate factor cutoff value 174 and the recovery rate factor alarm value 176 can be omitted or set high as desired for a particular application. In one embodiment, the default values ​​for the Allow Rate Recovery flag setting, recovery rate factor limit value box 172, recovery rate factor limit value 174, and / or rate factor alarm value Recovery 176 can be loaded into the infusion pump from a remote computer as part of a drug library editing program such as HOSPIRA MEDNET ™ software. In another embodiment, the default values ​​for the Allow Rate Recovery flag, recovery rate factor value box 172, recovery rate factor limit value 174, and / or recovery rate factor alarm value 176 are They can be loaded into the infusion pump by the user on the infusion pump. In another hybrid embodiment, the default values ​​can be set in a drug library downloaded to the pump and, if a setting in the drug library allows, the user can override or later modify them at the pump. In another embodiment, the manufacturer can predetermine all recovery rate behavior and code it into the pump, without allowing any customization by the user.

Figures 6A and 6B are screenshots of a graphical user interface and details of the graphical user interface, respectively, for configuring a drug library, in accordance with the present invention. The graphical user interface 200 can be displayed on the input / display device 38 of the MMU 12 (as shown in Figure 2) and is used to receive data to create or update the drug library, such as the rate factor. recovery rate, the Allow Rate Recovery indication setting, the maximum recovery rate factor setting, the maximum recovery rate factor alarm setting and the like.

Referring to Figures 6A and 6B, the graphical user interface 200 includes a table 201 for receiving different drugs and therapeutic agents in the drug library database. Drug List 202 includes a list of the names of the drugs in the drug library, which could be generic names, brand names, or both. The drug list can include multiple entries for the same drug but different strengths or clinical uses (cardiac, renal, pediatric). The allowed rate recovery flag list 204 includes the allowed rate recovery flag setting for each drug / concentration / use entry (drug entry for short) in the drug list 202 to determine whether to allow recovery of fee for entry of particular drug. In addition, the setting of the Allow Rate Recovery flag can be a function of the pump type and / or the location of the clinical care area. The maximum rate recovery list 206 includes the maximum recovery rate factor setting for each drug entry in the drug list 202 for which rate recovery is allowed. The maximum recovery rate factor setting may also be a function of pump type and clinical care area location. In one embodiment, the maximum recovery rate factors allowed are regular linear percentages at predetermined intervals, eg, 5%, 10%, 15%, 20%, etc. Table 201 may also include other parameters that restrict or limit the maximum drug recovery rate, such as the normal global rate restrictions already configured using the mMu 12 software and HOSPIRA MEDNET ™ (lower hard limit, lower soft limit, soft limit upper and / or upper strict limit). The maximum recovery rate factor alarm setting and other maximum drug recovery rate limits for each drug input may also be a function of pump type and clinical care area location.

The recovery rate factor is a simple percentage applied to the desired infusion rate to obtain a recovery infusion rate when the actual cumulative infusion volume is less than the expected cumulative infusion volume. In some cases, the desired infusion rate is entered directly as a rate or volume per unit of time, such as ml / hr. In other cases, the desired infusion rate is a calculated value based on a dose and the weight or body surface area of ​​the patient. For example, a dose of 10 ml / kg / h may be prescribed for a patient weighing 100 kg. Therefore, the desired infusion rate would be calculated as 1000 ml / hr. In other cases, the desired infusion rate is calculated based on the dose and concentration of drug in the container. For example, if a 10 mcg / h dose is prescribed to be delivered from a 1000 ml container of liquid that has a 100 mcg concentration of the drug, then the desired infusion rate is calculated as 100 ml / h. There are other alternative dosage units that are known in the art to provide calculated target infusion rates. In one embodiment, the recovery rate factor is added to the desired infusion rate. In another embodiment, the recovery rate factor (eg, 1.05) is multiplied by the desired infusion rate. In one embodiment, the allowed recovery rate factors are regular linear percentages at predetermined intervals, eg, 5%, 10%, 15%, 20%, etc. to make it easier for the user to select a recovery rate factor. The recovery rate factor applies a linear fit to the desired infusion rate and does not depend on any input of physiological factors from the patient. Therefore, configurable closed-loop supply rate recovery is straightforward and does not rely on complex algorithms or control schemes. Instead, the feedback mechanism of this algorithm is based only on the cumulative volume measured versus expected.

ES 2 839 092 T3 supplied over time by the pump. The new rate Y is determined by a simple one-order equation X + AX ​​or AX; where A equals the recovery rate factor as described above.

The Allow Rate Recovery flag setting as a function of pump type can take into account the different types, makes and models of pumps, as well as the uses for which various types of pumps are used. In one example, for general infusion, such as saline solutions or the like, a type of pump can be used that uses a cartridge and drives a plunger with a stepping motor, so that there is little risk in allowing rate recovery. In another example, another type of pump may be used that uses a pre-filled syringe for analgesics or opiates, so it may not be desirable to allow rate recovery. Other types of pumps may have multiple uses or therapies and it may be desirable to control the enablement of the recovery rate feature for each of the plurality of uses available with such type of pump.

The Allow Rate Recovery flag setting may be a function of the clinical care area location. In one example, it is possible that an infusion pump used in a treatment area where patients are in a serious or critical condition, such as an emergency or operating room, may not wish to allow rate recovery. In another example, an infusion pump used in a treatment area where patients are in good condition may want to allow rate recovery.

Those skilled in the art will appreciate that Table 201 may also include other data as desired for a particular application. Table 201 may include other exemplary columns 208 to get additional data for different drugs, such as external drug identification numbers, drug display names, drug concentration / container volume, selected drug rule set (label only, Limited, Full), Drug Dosing Unit, Drug Dosing Limits (Lower Hard Limit, Lower Soft / Alarm Limit, upper alarm / soft limit and / or upper hard limit) or the like.

The drug library provides flexibility for various combinations of parameters as desired for a particular application. The drug library can have different Allow Rate Recovery flag settings for different drugs or drug entries in the drug library. The drug library may have different maximum allowable recovery rate factor settings for different drugs in the drug library. The drug library can have a given drug listed in multiple different clinical care areas (CCA) in the drug library with at least one of the different Allow Rate Recovery flag settings and different maximum recovery rate factor settings for a given drug.

Figure 7 is a graph of an infusion volume and infusion rate versus time modeled for an infusion with an infusion pump employing configurable closed-loop delivery rate recovery, in accordance with the present invention. The graph 300 includes the expected cumulative infusion volume 310, the actual cumulative infusion volume 320, and the infusion rate 330.

The expected cumulative infusion volume 310 increases linearly at a desired infusion rate of 100 ml per hour. The actual cumulative infusion volume 320 increases linearly from 0:00 to 1:00 at the originally programmed or desired infusion rate 330 of 100 ml per hour. At 1:00, the infusion is stopped so that the infusion rate 330 remains at approximately zero and the actual accumulated infusion volume 320 remains around 100 ml until time 1:15, when the infusion is resumed. At time 1:15, the actual cumulative infusion volume 320 is less than the expected cumulative infusion volume 310, so the infusion rate increases by the recovery rate factor of 15% and the infusion resumes at a Recovery infusion rate of 115 ml per hour from time 1:15 to time 2:00. At 2:00, the actual cumulative infusion volume 320 has not yet reached the expected cumulative infusion volume 310 and the infusion is stopped once more. The infusion rate 330 remains at approximately zero and the actual accumulated infusion volume 320 remains at around 200 ml until time 2:10, when the infusion is resumed. From time 2:10 to time 3:20, the infusion is delivered at the recovery infusion rate of 115 ml per hour until the actual cumulative infusion volume 320 equals the expected cumulative infusion volume 310 at 3 o'clock. : 20, when the infusion rate 330 is reduced to the originally programmed or desired infusion rate of 100 ml per hour. At 3:45, the infusion is stopped once more so that the infusion rate 330 remains at approximately 0 and the actual accumulated infusion volume 320 remains at approximately 375 ml until the infusion is resumed at 3:55. From time 3:55 to time 4:40, the infusion is delivered at the recovery infusion rate of 115 ml per hour until the actual cumulative infusion volume 320 equals the expected cumulative infusion volume 310 at 4 o'clock. : 40, when the infusion rate 330 is reduced to the originally programmed or desired infusion rate of 100 ml per hour. Therefore, the desired cumulative volume of 500 ml has been delivered at the programmed time 5:00 despite three interruptions in the infusion.

Figure 8 is a block diagram of a control model for an infusion pump employing configurable closed loop delivery rate recovery in accordance with the present invention. The control model 400 includes an infusion volume calculator 410, a volume comparator 420, a pump controller 430, a pump driver 440, and a flow integrator 450. The infusion volume calculator 410 receives a desired infusion rate signal 412 and generates an expected cumulative infusion volume signal 414 of the originally programmed desired infusion rate signal 412 and the elapsed time. Volume comparator 420 receives the

ES 2 839 092 T3 expected infusion volume signal 414 and an actual accumulated infusion volume signal 452, and generates a volume error signal 422 from the expected accumulated infusion volume signal 414 and the actual cumulative infusion 452. The pump controller 430 also receives the desired infusion rate signal 412 and the accumulated volume error signal 422, and generates a pump driver signal 432 of the desired infusion rate signal 412 and the volume error signal. accumulated 422. Pump driver 440 receives signal from pump driver 432 to deliver infusion 442. For modeling purposes, the pump driver 440 is subject to disturbances 444 which can cause or result in interrupted delivery of infusion 442. The disturbance may include, but is not limited to, shutdowns due to alarms, occlusions, and other failures. Flow integrator 450 may function to monitor pump driver 440 and / or infusion 442 and generate the actual cumulative infusion volume signal 452. In one embodiment, the pump driver 440 moves the plunger in a syringe and the flow integrator 450 senses the position of the plunger / pump driver. In another embodiment, pump driver 440 is a stepper motor and flow integrator 450 counts pump strokes or motor steps. In yet another embodiment, pump driver 440 is a rotary pump and flow integrator 450 counts pump rotations. The present invention could also be applied with a drip counting device to provide the necessary feedback on actual flow rate and / or accumulated volume. Returning to the discussion of the embodiment for powered pumps, the pump driver signal 432 is a function of the desired infusion rate signal 412 multiplied by a recovery rate factor when the volume error signal 422 meets (equals and / or exceeds) a threshold indicating that the actual accumulated infusion volume is less than the expected accumulated infusion volume, to recover the interrupted delivery of an infusion. The pump driver signal 432 is a function of the desired infusion rate signal 412 alone or returns to the originally programmed or set rate when the accumulated volume error signal 422 indicates that the actual accumulated infusion volume is greater than or equal than expected cumulative infusion volume.

Figure 9 is a flow chart of a method for configuring a drug library for use with an infusion system employing configurable closed loop delivery rate recovery in accordance with the present invention. The method 500 includes providing a graphical user interface 502 for modifying a drug library of the drug management unit; receiving a recovery rate factor at graphical user interface 504; update drug library with recovery rate factor 506; and transmitting the updated drug library to the memory of an infusion pump 508. The method 500 can be performed in a drug management unit that has a processing unit and a storage medium coupled to the processing unit, the storage medium contains a programming code executable by the processing unit to perform the steps of method 500.

Those skilled in the art will appreciate that the drug library may include additional settings for a method of configuring a drug library for use with an infusion system employing a configurable closed loop delivery rate recovery as desired for an application. particular. In one embodiment, the drug library may further include an Allow Rate Recovery flag setting having an enable setting and a disable setting, the Allow Rate Recovery flag setting being a function of a selected parameter from the group. consisting of drug / concentration / use entry, pump type, and clinical care area location. In another embodiment, the drug library may further include a maximum recovery rate factor setting that has a numerical value, the maximum recovery rate factor setting being a function of a parameter selected from the group consisting of drug input. , type of pump and location of clinical care area. In yet another embodiment, the drug library may further include a maximum recovery rate factor alarm setting having a numerical value, the maximum recovery rate factor alarm setting being a function of a parameter selected from the group that It consists of drug entry, pump type, and clinical care area location.

Figure 10 is a flow chart of a method of operating an infusion pump employing configurable closed loop delivery rate recovery in accordance with the present invention. Method 600 includes entering a desired infusion rate 602 for the infusion pump; calculating an expected cumulative infusion volume 604 as a function of infusion rate time; requesting the infusion pump to deliver the infusion at the desired infusion rate 606; determining an actual cumulative infusion volume 608 at a given time; and determining whether the actual cumulative infusion volume is less than the expected cumulative infusion volume 609.

When the actual accumulated infusion volume is less than the expected accumulated infusion volume, the method 600 continues to increase the desired infusion rate by a recovery rate factor to generate a recovery infusion rate 610 and request the infusion pump to deliver the infusion at the 612 recovery infusion rate. When the actual cumulative infusion volume is not less than the expected cumulative infusion volume, the method 600 continues to monitor the pump output and deliver the infusion at the originally programmed or desired infusion rate. The method 600 may also request the infusion pump to deliver the infusion at the originally programmed or desired infusion rate after delivery of the infusion at the recovery infusion rate 612 when the actual accumulated infusion volume equals the volume of expected accumulated infusion. Once the actual cumulative infusion volume is equal to or greater than the expected cumulative infusion volume, the method 600 continues to determine whether or not the cumulative total volume has been delivered.

ES 2 839 092 T3 prescribed or programmed. Method 600 stops if all volume has been delivered, or backs up to step 606 if more volume remains to be delivered.

Method 600 may also allow the user of the infusion pump to provide information. The method 600 may include a user at the infusion pump who enters a flag setting from Allow Rate Recovery to a disable setting to disable the increase and delivery rate recovery function. Method 600 may include the user at the infusion pump who enters the recovery rate factor at a desired value. In one embodiment, the recovery rate factors are regular linear percentages at predetermined intervals, eg, 5%, 10%, 15%, 20%, etc. In other embodiments, the drug library editor or pump may allow the user more flexibility to customize the values ​​and the intervals between them.

The method 600 may or may not require user action before applying the recovery infusion rate if desired for a particular application. In one embodiment, the request to the infusion pump to deliver the infusion at the recovery infusion rate 612 may occur automatically, without user action, by increasing the desired infusion rate by a recovery rate factor to generate a recovery rate. recovery infusion 610.

In another embodiment, method 600 may include announcing an alarm or warning prior to increasing the desired infusion rate by a recovery rate factor to generate a recovery infusion rate 610, and requesting the user to acknowledge the alarm and confirm that recovery rate behavior is desired before requesting the infusion pump to deliver the infusion at the recovery infusion rate. 612. In another embodiment, method 600 may include announcing an alarm or warning after increasing the desired infusion rate by a recovery rate factor to generate a recovery infusion rate 610, and allowing the user to confirm or reject the behavior of the infusion. recovery rate. If the recovery rate behavior is rejected, the infusion will revert to the originally programmed infusion rate.

Method 600 can also provide limits and alarms in response to user input. In one embodiment, the method 600 further includes rejecting the input recovery rate factor when the desired value is greater than the maximum recovery rate factor setting. In another embodiment, method 600 further includes providing an alarm when the desired value is greater than the maximum recovery rate factor alarm setting. In yet another embodiment, increasing the desired infusion rate by a recovery rate factor in method 600 includes receiving an alarm when at a certain time the actual accumulated infusion volume is less than the expected accumulated infusion volume; and acknowledging the alarm prior to increasing the desired infusion rate by a recovery rate factor to generate a recovery infusion rate.

The method 600 can be performed on an infusion pump having a processor and memory coupled to the processor, the memory containing the programming code executable by the processor to perform the steps of the method 600. In one embodiment, the infusion pump 14 may be in electronic communication with a drug management unit 12 and the recovery rate factor may be part of an updated drug library transmitted from the drug management unit 12 and received at the medical device 14.

Terms of equality and inequality (less than, greater than) as used herein as commonly used in the art, that is, taking into account the uncertainties present in measurement and control systems. Thus, such terms can be read as approximately equal, approximately less than and / or approximately greater than.

In one example, two values ​​can be considered equal when they are within 5% of each other. In other aspects of the invention, the manufacturer of the pump, the publisher of the drug library, or the user of the pump may establish an acceptable threshold of drift or hysteresis.

Although the embodiments of the invention described herein are presently considered preferred, various changes and modifications can be made without departing from the scope of the invention. The scope of the invention is defined by the appended claims.