Systems and methods for controlling partial delivery pumping in an infusion system

Abstract

A method and system for delivering a partial bolus using an infusion pump is disclosed. An exemplary method includes storing a programmed dose to be administered in response to a request from a patient and instructing the pump to begin dispensing the programmed dose of fluid from a fluid source. The method further includes receiving an indication that the pump has stopped pumping, determining the partial dose, and generating an alarm that the fluid source has run out when the partial dose equals a value greater than zero. Additionally, the method includes replacing the runout fluid source with a subsequent fluid source, dispensing the partial dose from the subsequent fluid source, and preventing any subsequent dispensing of fluid from the subsequent fluid source for a programmed lockout period.

Description

[Technical Field]

[0001] Technical Field

[0002] This application relates to electronic devices, and more particularly to control systems for controlling the performance of infusion pump systems. [Background technology]

[0003] background

[0004] The present disclosure provides novel and innovative methods and systems for fluid delivery control in electronic devices, including medical devices. In various embodiments, the device includes an infusion pump. Generally, medical patients sometimes require either precise delivery of medication at set periodic intervals or on-demand medication delivery via patient-initiated demand. Medical pumps have been developed to provide controlled drug infusion, whereby drugs can be administered at precise doses that maintain drug concentrations within therapeutic margins and outside unnecessary or, in some cases, toxic ranges. Medical pumps can provide appropriate drug delivery to patients in controllable doses that do not require frequent attention.

[0005] Infusion pump configurations include elastomeric pumps that squeeze solution from a flexible container, such as a balloon, into IV tubing for delivery to the patient. Alternatively, spring-loaded pumps pressurize a solution container or reservoir. Certain pump designs utilize a cartridge containing a flexible compartment that is compressed by a pressure roller to expel the solution. Syringe-based infusion pumps are also known, in which a drive mechanism moves the syringe plunger to deliver the fluid to the patient. These infusion pumps typically include a housing adapted to receive a syringe assembly, a drive mechanism adapted to move the syringe plunger, a pump control unit with various operational controls, and a power source for powering the pump, including the drive mechanism and controls.

[0006] Medical pumps can facilitate the administration of intravenous therapy to patients both inside and outside of clinical settings. One type of medical pump within a clinical setting is the patient-controlled analgesic (PCA) pump. PCA pumps typically deliver pain medication and allow patients to request medication delivery from the PCA pump, called a PCA bolus, via a bolus cord attached to the pump. PCA pumps can also deliver pre-programmed intermittent boluses by programming the PCA pump to deliver specific bolus amounts with a specific time interval between two boluses. However, if a patient requests a PCA bolus and the amount remaining in the syringe is less than the requested bolus amount, the pump will not deliver any medication because the requested amount is not available. The patient may not receive the entire requested, programmed bolus amount, and a clinician may or may not visit to address the patient's pain. This can result in an abrupt interruption or inadequate treatment, resulting in a significant reduction in pharmacological effect and a worsening of the patient's condition.

[0007] Another drawback of existing PCA pump control systems is the waste of remaining medication, typically opioids, in the syringe. Hospitals follow strict protocols for tracking the amount of opioid administered or discarded to prevent unauthorized access to opioids. In this case, clinicians must discard the remaining medication, creating the potential for medication misuse and without a means or system of accountability. Additionally, when scaled to account for multiple patients across a hospital system, the inefficiency and waste of discarding medication becomes apparent. This waste contributes to the removal of already scarce resources in the hospital system.

[0008] Several methods exist for ensuring that medical devices deliver medication at a specified rate. However, existing methods have several shortcomings, limitations, and drawbacks. For example, existing methods utilize an alarm to alert the clinician that the amount remaining in the syringe is less than the requested bolus amount and therefore the syringe needs to be replaced with a full syringe. However, this can result in an abrupt interruption of therapy or insufficient therapy, and a significant reduction in pharmacological effect due to the time required to replace the syringe and for the clinician to input instructions into the PCA pump. This can be particularly problematic when every minute counts without medication, such as when a patient is suffering from severe pain immediately after surgery. Therefore, to overcome these problems and drawbacks, a method and system for controlling pump operation and managing the delivery of partial medication doses to eliminate the downtime and inefficiencies associated with partial medication delivery is desired. Summary of the Invention [Means for solving the problem]

[0009] overview

[0010] The present disclosure provides new and innovative methods and systems for controlling the operation of pumps and managing the delivery of partial pharmaceutical doses, such as PCA pumps. In various embodiments, a computer-implemented method includes, in response to a request from an operator, storing in a memory of the pump a programmed dose of fluid from a fluid source to be administered, and, upon receipt of a request at a controller of the pump to dispense the programmed dose, instructing the pump, via the controller, to begin dispensing the programmed dose of fluid from the fluid source.

[0011] In another aspect of the present disclosure, which may be used in combination with any other aspect or combination of aspects enumerated herein, a computer-implemented method includes instructing a pump, via a controller, to receive an indication that the pump has stopped pumping.

[0012] In another aspect of the present disclosure, which may be used in combination with any other aspect or combination of aspects enumerated herein, a computer-implemented method includes instructing a pump, via a controller, to determine a partial dose equal to the difference in volume between the programmed dose and the volume of fluid actually dispensed from the fluid source.

[0013] In another aspect of the present disclosure, which may be used in combination with any other aspect or combination of aspects enumerated herein, the computer-implemented method includes instructing the pump, via the controller, to repeat in response to a subsequent request from the patient when the partial dose equals zero and a programmed lockout period has elapsed.

[0014] In another aspect of the present disclosure, which may be used in combination with any other aspect or combination of aspects enumerated herein, the computer-implemented method includes instructing the pump, via the controller, to generate an alarm that the fluid source is depleted when the partial dose equals a value greater than zero and to record the volume difference between the programmed dose and the volume of fluid dispensed from the fluid source in a history log stored in memory.

[0015] In another aspect of the present disclosure, which may be used in combination with any other aspect or combination of aspects enumerated herein, a computer-implemented method includes instructing, via a controller, a pump to provide a prompt to replace the depleted fluid source with a subsequent fluid source in response to an alarm that the fluid source is depleted.

[0016] In another aspect of the present disclosure, which may be used in combination with any other aspect or combination of aspects enumerated herein, a computer-implemented method includes instructing a pump, via a controller, to dispense a partial dose from a subsequent fluid source after receiving an indication that the subsequent fluid source is fluidly coupled to the pump.

[0017] In another aspect of the present disclosure, which may be used in combination with any other aspect or combination of aspects enumerated herein, a computer-implemented method includes instructing a pump, via a controller, to prevent any subsequent dispensing of fluid from a subsequent fluid source for a programmed lockout duration.

[0018] In another aspect of the present disclosure, which may be used in combination with any other aspect or combination of aspects enumerated herein, the computer-implemented method includes the fluid source and the subsequent fluid source containing the same fluid.

[0019] In another aspect of the present disclosure, which may be used in combination with any other aspect or combination of aspects enumerated herein, a computer-implemented method includes a fluid source and a subsequent fluid source housed in a syringe configured to engage with a pump.

[0020] In another aspect of the present disclosure, which may be used in combination with any other aspect or combination of aspects enumerated herein, the computer-implemented method includes the fluid source and the subsequent fluid source including a pain reliever.

[0021] In another aspect of the present disclosure, which may be used in combination with any other aspect or combination of aspects enumerated herein, the computer-implemented method includes instructing the pump to repeat the method in response to a subsequent request from the patient if a lockout period programmed by the pump's controller has elapsed.

[0022] In various embodiments, the infusion pump apparatus includes a pumping mechanism configured to dispense a programmed dose from a fluid source, a memory that stores the programmed dose and is configured to record a history log, and a patient demand device.

[0023] In another aspect of the present disclosure, which may be used in combination with any other aspect or combination of aspects enumerated herein, an infusion pump apparatus includes a pumping mechanism, a memory, and a processor in communication with a patient request device.

[0024] In another aspect of the present disclosure, which may be used in combination with any other aspect or combination of aspects enumerated herein, an infusion pump apparatus includes a processor configured to dispense a programmed dosage from a fluid source upon a patient request via a patient request device.

[0025] In another aspect of the present disclosure, which may be used in combination with any other aspect or combination of aspects enumerated herein, the infusion pump device includes a processor configured to determine a partial dose equal to the difference in volume between the programmed dose and the volume actually dispensed from the fluid source.

[0026] In another aspect of the present disclosure, which may be used in combination with any other aspect or combination of aspects enumerated herein, the infusion pump device includes a processor configured to repeat in response to a subsequent request from the patient if the partial dose equals zero and a programmed lockout period has elapsed.

[0027] In another aspect of the present disclosure, which may be used in combination with any other aspect or combination of aspects enumerated herein, the infusion pump device includes a processor configured to generate an alarm that the fluid source is depleted if the partial dose is equal to a value greater than zero, and to record in a history log the volumetric difference between the programmed dose and the amount of fluid actually administered.

[0028] In another aspect of the present disclosure, which may be used in combination with any other aspect or combination of aspects enumerated herein, an infusion pump device includes a processor configured to, in response to an alarm generated that a fluid source is depleted, dispense a partial dose from a subsequent fluid source after a clinician replaces the depleted fluid source with the subsequent fluid source.

[0029] In another aspect of the present disclosure, which may be used in combination with any other aspect or combination of aspects enumerated herein, the infusion pump device includes a processor configured to prevent subsequent dispensing of fluid from a subsequent fluid source for a programmed lockout duration.

[0030] In another aspect of the present disclosure, which may be used in combination with any other aspect or combination of aspects enumerated herein, the infusion pump device includes a processor configured to repeat in response to a subsequent request from the patient if a programmed lockout period has elapsed.

[0031] In another aspect of the present disclosure, which may be used in combination with any other aspect or combination of aspects enumerated herein, the infusion pump device includes the fluid source and the subsequent fluid source comprising the same fluid.

[0032] In another aspect of the present disclosure, which may be used in combination with any other aspect or combination of aspects enumerated herein, the infusion pump device includes a fluid source and a subsequent fluid source comprising a syringe.

[0033] In another aspect of the present disclosure, which may be used in combination with any other aspect or combination of aspects enumerated herein, the infusion pump device includes a fluid source and a subsequent fluid source containing an analgesic agent.

[0034] In another aspect of the present disclosure, which may be used in combination with any other aspect or combination of aspects enumerated herein, the infusion pump device includes the patient request device being a handheld pendant having a button in operative communication with a processor of the infusion pump device.

[0035] Additional features and advantages of the disclosed method and apparatus are described in, and will be apparent from, the following detailed description and drawings. The features and advantages described herein are not all-inclusive, and in particular, many additional features and advantages will become apparent to those skilled in the art upon consideration of the drawings and description. Furthermore, it should be noted that the language used herein has been chosen primarily for readability and descriptive purposes, and not to limit the scope of the inventive subject matter. [Brief explanation of the drawings]

[0036] BRIEF DESCRIPTION OF THE DRAWINGS

[0037] The description will be more fully understood with reference to the following figures, which are presented as exemplary embodiments of the present disclosure and should not be construed as a complete recitation of the scope of the present disclosure.

[0038] [Figure 1A] 1A and 1B illustrate an exemplary PCA pumping device compatible with the disclosed methods according to one embodiment of the disclosure. [Figure 1B] 1A and 1B illustrate an exemplary PCA pumping device compatible with the disclosed method according to one aspect of the present disclosure.

[0039] [Figure 2] FIG. 2 illustrates a block diagram of an electronic device according to an exemplary embodiment of the present disclosure.

[0040] [Figure 3] FIG. 3 illustrates a graphical user interface (GUI) readout of a PCA pump according to an exemplary embodiment of the present disclosure.

[0041] [Figure 4] FIG. 4 shows a conceptual diagram of timing of partial dose delivery according to an exemplary embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0042] Detailed Description

[0043] Referring now to the drawings, technology is disclosed for novel and innovative systems and methods for the delivery of partial medications in devices, such as medical devices. Various devices, such as infusion pumps, can be used to deliver therapies to patients. These therapies typically involve delivering medications at specific doses. Medical pumps can facilitate the administration of intravenous therapies to patients both inside and outside of clinical settings. One type of medical pump in clinical settings is the patient-controlled analgesic (PCA) pump. PCA pumps typically deliver pain medications and allow patients to request medication delivery from the PCA pump, called a PCA bolus, via a bolus cord attached to the pump. PCA pumps can also deliver pre-programmed intermittent boluses by programming the PCA pump to deliver specific bolus amounts with specific time intervals between two boluses. However, if a patient requests a PCA bolus and the amount remaining in the syringe is less than the requested bolus amount, the pump will not deliver any medication because the requested amount is not available.

[0044] Existing control techniques for PCA pumps emphasize precise control of the delivered dose, but in doing so, they overlook important issues and create several drawbacks. For example, if the volume in the PCA pump's syringe is less than the requested dose, the PCA pump will not deliver a bolus because the requested dose is not available in the syringe. As a result, the patient does not receive any dose until a clinician arrives at the patient's bedside to replace the syringe, or the user must deliver the pain medication through an alternative route. Existing control techniques also result in the waste of the remaining medication in the syringe. Hospitals follow strict protocols for tracking the amount of medication being used or discarded to prevent unauthorized access to expensive and / or abuse-prone medications, such as opioids. Systems and methods according to aspects of the present disclosure can control a PCA or similar infusion pump to accurately deliver the programmed dose in two partial bolus deliveries. These technologies can reduce the time a patient is not taking the entire programmed dose, limit pain and discomfort to the patient, and ensure that beneficial medication is not wasted or placed in a position where it can be misused and abused.

[0045] Various systems and processes according to aspects of the present disclosure are described in more detail below.

[0046] Systems and Devices

[0047] 1A and 1B illustrate an exemplary PCA pumping device according to one embodiment of the present disclosure. Device 100 (e.g., an infusion pump) includes a graphical user interface 110 that is used to program a controller of PCA pumping device 100. Device 100 may include any other electronic devices as desired. Device 100 includes a fluid source 112, typically a syringe, that is fluidly and operably connected to device 100. Device 100 can be programmed to receive fluid from fluid source 112 and dispense the fluid at a specified rate using various processes as described herein.

[0048] The device 100 includes a case 114 that provides access to the fluid source 112. The case 114 may be locked to prevent the patient (or others other than an authorized clinician) from accessing the fluid source 112. The case 114 may be transparent or opaque.

[0049] Actuator 116 is configured to move fluid outward from fluid source 112. With respect to syringe fluid source 112, actuator 116 is configured to apply a force to a plunger (or plunger flange) to cause fluid to be dispensed to a patient via a patient IV line. Actuator 116 is controlled by a controller of device 100, as described below.

[0050] FIG. 2 illustrates a block diagram of an electronic device according to an exemplary embodiment of the present disclosure. Device 200 may include a processor 210, memory 220, a communication interface 230, sensors 240, a controller, a motor and pump 242, and / or a power supply 244. Processor 210 may also be referred to as a central processing unit (CPU). Processor 210 may include one or more devices capable of executing instructions encoding arithmetic, logical, and / or I / O operations. In many embodiments, processor 210 may be a single-core processor capable of typically executing a single instruction at a time (or processing a single instruction pipeline) and / or a multi-core processor capable of executing multiple instructions simultaneously. In various embodiments, processor 210 may be implemented as a single integrated circuit, two or more integrated circuits, and / or may be a component of a multi-chip module in which individual microprocessor dies are included in a single integrated circuit package and therefore share a single socket.

[0051] The memory 220 may include any combination of volatile and / or non-volatile memory devices, such as RAM, ROM, EEPROM, or any other device capable of storing data. In some embodiments, the memory 220 stores various data 222. In various embodiments, the data 222 causes the device 200 to perform any of the various processes as described herein.

[0052] The communication interface 230 may include a network device (e.g., a network adapter or any other component that connects a computer to a computer network), a Peripheral Component Interconnect (PCI) device, a storage device, a disk drive, a sound or video adapter, a photo / video camera, a printer device, a keyboard, a display, etc. The communication interface 230 may communicate over various networks as needed. These networks may include a LAN (Local Area Network), a WAN (Wide Area Network), a telephone network (e.g., a Public Switched Telephone Network (PSTN)), a Session Initiation Protocol (SIP) network, a wireless network, a point-to-point network, a star network, a token ring network, a hub network, a wireless network (including protocols such as EDGE, 3G, 4G LTE, Wi-Fi, 5G, WiMAX, etc.), the Internet, etc. Various authentication and authorization technologies may be used to secure communications, such as username / password, open authentication (OAuth), Kerberos, Secure ID, digital certificates, etc.

[0053] The sensor device 240 can include various sensors for sensing various environmental and / or physical conditions. In some embodiments, the sensor device 240 can be used to measure and / or record data regarding a patient being treated for a particular condition. In various embodiments, the sensor device 240 can measure motor position, pump position, voltage, battery level, fluid flow rate, and / or any other data as described herein. The controller, pump, and motor 242 can include any device used to perform an action, such as electronic components, microcontrollers (such as PID controllers), motors, pumps, actuators, etc. These actions can include, but are not limited to, adjusting the electrical output of the device, pumping fluid provided by a fluid source, adjusting medication delivery (particularly within a desired flow rate accuracy), etc. In various aspects, the motor and pump are separate components. In many aspects, the motor and pump are a single component. In some aspects, some or all of the controller, motor, and pump 242 are implemented using the processor 210. The power source 244 can provide power to any of the components of the device 200. Power source 244 may include a battery, a capacitor, a transformer, a charging circuit, and / or any other device capable of providing AC and / or DC power to the components of device 200. In various embodiments, power source 244 includes an AC / DC converter that converts AC power to 3.3V, 5V, and / or 12V DC power to supply to the components of device 200. The charging circuit of power source 244 may include any suitable charger, such as an AC charger, a DC charger, a solar panel, an energy harvester, etc.

[0054] While a particular architecture for an electronic device according to an embodiment of the present disclosure is conceptually illustrated in FIG. 2 , any of a variety of architectures can be utilized, including those that store data or applications on a disk or some other form of storage and load them into memory at runtime. Additionally, any data utilized by the system can be cached and transmitted when a network connection (such as a wireless network connection via a communications interface) becomes available. In various embodiments, memory includes circuitry that stores instructions, such as, but not limited to, memory cells constructed using transistors. Similarly, a processor can include logic gates formed from transistors (or any other devices) that dynamically perform operations based on instructions stored in memory. In some embodiments, instructions are embodied in a configuration of logic gates within the processor to implement and / or perform the operations described by the instructions. In this manner, the systems and methods described herein can be performed using both general-purpose computing hardware and single-purpose devices.

[0055] FIG. 3 illustrates a graphical user interface readout of a PCA pump according to an exemplary embodiment of the present disclosure. As described in more detail below, the purpose of the present disclosure is to control the operation of the pump and manage the delivery of partial drug doses. In the process of delivering partial drug doses, the methods and systems disclosed herein detect and record the number of partial doses delivered. The graphical user interface (GUI) 300 of the disclosed pump provides the clinician or any other user of the pump with an indication of how many partial doses have been delivered. In addition, the GUI 300 may provide the clinician with additional information, such as the drug currently in the pump's fluid source, the drug concentration, the number of doses attempted, the number of doses delivered, the total amount of drug delivered to the patient, and the duration of time since the pump was last cleared. The GUI 300 may also provide an indication of the current battery status of the battery powering the pump, the pump's current network connection status, the current amount of alarms the pump has set, and the time of day.

[0056] In an additional embodiment, the infusion pump device includes memory capable of storing programmed doses and recording a history log. The memory may be any conventional computer-readable or machine-readable medium, including volatile or non-volatile memory, such as RAM, ROM, flash memory, magnetic or optical disks, optical memory, or other storage media.

[0057] In additional embodiments, the infusion pump apparatus includes a patient request device. For example, the patient request device may be a PCA bolus cord in operative communication with the pump, specifically a processor in communication with the pumping mechanism. Additionally, the patient request device may be a handheld pendant having a button in operative communication with the infusion pump apparatus's processor. The patient request device may also be any handheld, corded, or wireless device capable of providing input and / or instructions to the infusion pump apparatus's processor.

[0058] In additional embodiments, the infusion pump apparatus includes a pumping mechanism, memory, and a processor in communication with the patient request device. For example, the processor may be a single-core processor typically capable of executing one instruction at a time (or processing a single instruction pipeline), and / or a multi-core processor capable of executing multiple instructions simultaneously. In various aspects, the processor may be implemented as a single integrated circuit, two or more integrated circuits, and / or may be a component of a multi-chip module in which individual microprocessor dies are contained in a single integrated circuit package and therefore share a single socket.

[0059] Additionally, the infusion pump device processor can perform several tasks, including dispensing a programmed dose from the fluid source when the patient issues a request via the patient request device. The infusion pump device processor can also determine a partial dose equal to the volumetric difference between the programmed dose and the volume actually dispensed from the fluid source in response to the patient request. If the partial dose is equal to zero, the processor instructs the pump to repeat the previous dispense step in response to a subsequent request from the patient if a programmed lockout period has elapsed. Alternatively, if the partial dose is equal to a value greater than zero, the processor instructs the pump to generate an alarm that the fluid source has run out and record the volumetric difference between the programmed dose and the volume of fluid actually dispensed in a history log.

[0060] In additional embodiments, the infusion pump device's processor can then, in response to an alarm being generated that a fluid source has been depleted, dispense a partial dose from the subsequent fluid source only after the depleted fluid source has been replaced with the subsequent fluid source. For example, a clinician can manually replace the depleted fluid source with the subsequent fluid source. Also, in additional embodiments, the infusion pump device can replace the depleted fluid source with the subsequent fluid source via automated means without requiring human intervention. For example, the infusion pump can be configured to maintain two fluid sources and / or to replace the active (depleted) fluid source with another (fresh) fluid source from a reservoir area. In one embodiment, the fluid source and the subsequent fluid source can be the same fluid or different fluids. Additionally, the fluid source and the subsequent fluid source can be syringes or any other containers that contain fluid and can engage a pumping mechanism.

[0061] In an additional embodiment, the processor of the infusion pump device can then prevent any subsequent dispensing of fluid from the subsequent fluid source for the entire programmed lockout duration. As discussed above, an unintentional overdose resulting from a patient receiving excessive medication delivery can be extremely dangerous. Therefore, a programmed lockout duration during which the pump cannot deliver subsequent doses is an aspect of the infusion pump device that enhances patient safety.

[0062] Finally, in additional embodiments, the processor of the infusion pump device can repeat the previously disclosed process in response to a subsequent request from the patient if the programmed lockout period has elapsed. For example, if the patient makes a request via the patient request device after the lockout period has elapsed, the processor instructs the infusion pump device to dispense the programmed dose from the fluid source and repeat the subsequent process associated with delivering a partial bolus, as disclosed herein.

[0063] Infusion pump device

[0064] In one embodiment, an infusion pump device for implementing partial bolus delivery includes a pumping mechanism configured to dispense a programmed dose from a fluid source. For example, the pumping mechanism may include components found in commercially available PCA pumps, such as the Baxter Novum IQ, or any other infusion pump. These components may include, but are not limited to, a means for maintaining a fluid source (syringe) within the pumping device, a drive mechanism for depressing the syringe to drive the syringe's fluid, a means for fluidly connecting the fluid source to the pump, and multiple sensors for monitoring the fluid source level and other conditions of the pumping device. In one embodiment, the fluid source may contain a pain reliever or any other fluid or medication that can be administered via an infusion pump.

[0065] In additional embodiments, the infusion pump device may include memory capable of storing programmed doses and recording a history log. The memory may be any conventional computer-readable or machine-readable medium, including volatile or non-volatile memory, such as RAM, ROM, flash memory, magnetic or optical disks, optical memory, or other storage media. Additionally, in one embodiment, the memory is retrievable by the processor.

[0066] In additional embodiments, the infusion pump apparatus may include a patient request device. For example, the patient request device may be a PCA bolus cord in operative communication with the pump, specifically a processor in communication with the pumping mechanism. Additionally, the patient request device may be a handheld pendant having a button in operative communication with the infusion pump apparatus's processor. The patient request device may also be any handheld, corded, or wireless device capable of providing input and / or instructions to the infusion pump apparatus's processor.

[0067] In additional embodiments, the infusion pump apparatus may include a processor in communication with the pumping mechanism, memory, and patient request device. For example, the processor may be a single-core processor typically capable of executing one instruction at a time (or processing a single instruction pipeline), and / or a multi-core processor capable of executing multiple instructions simultaneously. In various aspects, the processor may be implemented as a single integrated circuit, two or more integrated circuits, and / or may be a component of a multi-chip module in which individual microprocessor dies are contained in a single integrated circuit package and therefore share a single socket.

[0068] Additionally, the infusion pump device processor may be capable of performing several tasks, including dispensing a programmed dose from the fluid source when the patient issues a request via the patient request device. The infusion pump device processor may also be capable of determining a partial dose equal to the volumetric difference between the programmed dose and the volume actually dispensed from the fluid source in response to the patient request. If the partial dose is equal to zero, the processor instructs the pump to repeat the previous dispense step in response to a subsequent request from the patient if a programmed lockout period has elapsed. Alternatively, if the partial dose is equal to a value greater than zero, the processor instructs the pump to generate an alarm that the fluid source has run out and record the volumetric difference between the programmed dose and the volume of fluid actually dispensed in a history log.

[0069] In a further embodiment, the infusion pump device processor may then, in response to an alarm being generated that a fluid source has been depleted, dispense a partial dose from the subsequent fluid source only after the depleted fluid source has been replaced with the subsequent fluid source. For example, a clinician may manually replace the depleted fluid source with the subsequent fluid source. In a further embodiment, the infusion pump device may also be capable of replacing the depleted fluid source with the subsequent fluid source via automated means without the need for human intervention. In one embodiment, the fluid source and the subsequent fluid source may be the same fluid or different fluids. Additionally, the fluid source and the subsequent fluid source may be syringes or any other containers that contain fluid and can engage a pumping mechanism.

[0070] In an additional embodiment, the infusion pump device processor may then be able to prevent any subsequent dispensing of fluid from the subsequent fluid source for the entire programmed lockout duration. As discussed elsewhere herein, an unintentional overdose resulting from an excessive delivery of medication to a patient can be extremely dangerous. Therefore, a programmed lockout duration during which the pump cannot deliver subsequent doses enhances patient safety.

[0071] Finally, in additional embodiments, the processor of the infusion pump device may be capable of repeating the previously disclosed process in response to a subsequent request from the patient if the programmed lockout period has elapsed. For example, if the patient makes a request via the patient request device after the lockout period has elapsed, the processor instructs the infusion pump device to dispense the programmed dose from the fluid source and repeat the subsequent process associated with delivering a partial bolus as disclosed herein.

[0072] Device Operation Process

[0073] As described herein, it is desirable for PCA pumps (and various infusion pumps) to accurately dispense a specific dose of fluid in two partial bolus deliveries. In various embodiments, the infusion pump is programmed to deliver the programmed dose in either one full bolus or two partial boluses from the fluid source based on the available dose in the fluid source. The infusion pump can utilize a controller, such as a PID controller, to accurately determine motor and / or pump operation and dynamically compensate for errors in pump operation in performing the disclosed methods.

[0074] In one embodiment, a computer-implemented method for delivering a programmed dose in two partial boluses may include storing in a memory of a pump a programmed dose of fluid from a fluid source to be administered in response to a request from an operator, such as a patient. The fluid source may be contained in a syringe that engages the pump. In a further example, the fluid source may be contained in any other container that can engage the pump. Additionally, the method includes instructing the pump via a controller to perform a series of steps when a request to dispense the programmed dose is received. In one example, the request to dispense the programmed dose is initiated by the patient via a bolus code attached to the pump and received via the pump controller.

[0075] First, in one embodiment, the method may include instructing a pump to begin dispensing a programmed dose of fluid from a fluid source. For example, if the fluid source contains a pain reliever and the programmed dose is programmed to be 10 ml, the pump will begin dispensing 10 ml of the pain reliever to the patient via an infusion line fluidly connecting the pump to the patient. The programmed dose may vary based on several factors, including, but not limited to, the patient and the medication being delivered.

[0076] Next, in one embodiment, the method may include instructing the pump to receive an indication that the pump has stopped pumping. When pumping stops, the pump completes a series of steps, including determining a partial dose equal to the volume difference between the programmed dose and the volume of fluid actually dispensed from the fluid source. If the partial dose equals zero, the pump repeats in response to a subsequent request from the patient when a programmed lockout period has elapsed. In this example, the patient received the entire programmed dose in one bolus, and therefore, a second partial bolus is not necessary. In this example, the pump prevents any subsequent dispensing of fluid from the fluid source for a programmed lockout duration. The lock duration is the period of time during which additional patient-requested boluses cannot be administered to the patient after a patient-requested bolus has already been delivered to the patient. If the programmed lockout duration has expired, the method may include repeating the previously disclosed process in response to a subsequent request from the patient.

[0077] Next, in one embodiment, when the partial dose equals a value greater than zero, the method may include instructing the pump to generate an alarm indicating that the fluid source has been depleted and record the volumetric difference between the programmed dose and the volume of fluid dispensed from the fluid source in a history log stored in memory. In this example, the patient did not receive the entire programmed dose in one bolus, and therefore a second partial bolus is required. Additionally, in this embodiment, the method may include providing a prompt to replace the depleted fluid source with a subsequent fluid source in response to the alarm that the fluid source has been depleted. The prompt may be provided via a graphical user interface (GUI) on the pump that instructs the clinician (visually or audibly) to manually replace the depleted fluid source with the subsequent fluid source. In one embodiment, the fluid source and the subsequent fluid source comprise the same fluid, and the subsequent fluid source may also be contained in a syringe configured to engage with the pump. In one example, the method includes the pump replacing the depleted fluid source with the subsequent fluid source via automated means, without the need for human intervention.

[0078] Next, in one embodiment, the method may include instructing the pump to dispense a partial dose from the subsequent fluid source after receiving an indication that the subsequent fluid source is fluidly coupled to the pump. For example, according to the previous steps of the disclosed method, if the programmed dose is equal to 10 ml of fluid and the actual delivered dose in the first bolus is equal to 7 ml of fluid, the partial dose is equal to 3 ml of fluid. Therefore, after receiving an indication that the subsequent fluid source is fluidly coupled to the pump, the pump dispenses 3 ml of fluid from the subsequent fluid source.

[0079] Finally, in one embodiment, the method may include instructing the pump to prevent any subsequent dispensing of fluid from a subsequent fluid source for the duration of a programmed lockout period. This prevents inadvertent overdosing and overtreatment, which may be harmful to the patient. In addition, the pump controller may instruct the pump to repeat the method in response to a subsequent request from the patient if the programmed lockout period has elapsed. For example, after the lockout period has elapsed, the patient may request a programmed dose via a bolus code communicating with the pump to initiate a subsequent dose of medication.

[0080] FIG. 4 illustrates a flowchart of a partial bolus delivery process according to an exemplary embodiment of the present disclosure. Although process 400 is described with reference to the flowchart illustrated in FIG. 4, it will be understood that many other ways of performing the operations associated with process 400 may be used. For example, the order of some of the blocks may be changed, certain blocks may be combined with other blocks, one or more blocks may be repeated, and some of the described blocks are optional. Process 400 may be performed by processing logic, which may include hardware (circuitry, dedicated logic, etc.), software, or a combination of both. In various embodiments, the pulse mode operation process may be performed by a controller operating a motor and / or pump within an infusion pump device.

[0081] As also shown in Figure 4, the disclosed method and system allows for the delivery of pre-programmed intermittent boluses by programming the controller to deliver a specific bolus amount and time interval between two boluses. The bolus amount and minimum time interval between boluses are pre-programmed by the clinician. The pre-programmed bolus can be independent of the bolus requested by the patient.

[0082] 4 also depicts a bolus delivered to a patient over time. For example, at 405, a PCA bolus dose 402 is loaded and delivered to the patient. Then, at 410, a partial bolus 404 is delivered to the patient. The requested bolus amount may exceed the syringe capacity, at which point the syringe may be replaced and the remainder of the requested amount may be delivered to the patient. At 415 and later, a bolus may be delivered to the patient upon patient request. There may be a lockout interval, such as 406, during which the system will not deliver a bolus even if it receives a request from the patient.

[0083] Various scenarios contemplated by the methods and systems disclosed herein are shown in Table 1. [Table 1]

[0084] In the problem scenario described in Table 1 above, the fluid pump does not deliver the PCA bolus requested by the patient due to a lockout interval. In this scenario, the fluid pump determines that the patient has received the maximum number of boluses during a time period and that no further boluses are permitted during this lockout interval. As a result, the patient must wait until the lockout interval expires. In this case, the remaining drug in the semi-depleted syringe would go unused and wasted if it were replaced with a new syringe. For example, opioids are important and expensive drugs, and every small amount should be utilized.

[0085] To overcome this problem scenario, proposed Solution 1 allows the pump to deliver the remaining volume in the syringe, after which an empty syringe alarm is triggered. This alerts the clinician to replace the syringe with a full syringe and continue treatment delivery. The patient receives a partial dose of medication, but the interruption to treatment is minimal. Additionally, the entire volume in the syringe is delivered, eliminating medication waste. Once the syringe is replaced, the control system automatically delivers a pending bolus volume equal to the difference in volume between the programmed dose and the volume of fluid dispensed from the fluid source. Therefore, the patient receives the full bolus amount in two partial deliveries, which helps maintain the analgesic effect. However, the user may not be aware of the number of partial boluses. To remedy this problem, the number of partial boluses is recorded in a history log, as shown on the GUI screen, so the user knows the exact number of partial boluses compared to the total bolus delivered. Even if the entire bolus amount is delivered in two partial deliveries, it is counted as two partial boluses in the history log.

[0086] Proposal 2 is an update to Proposal 1, where as soon as the patient requests a bolus and the volume in the syringe becomes insufficient to deliver the requested (i.e., programmed) amount of medication, the control system will generate an alarm, which will alert the clinician as well as be recorded in the history log and displayed via the pump GUI, ensuring the clinician is aware of the partial bolus during its delivery, as well as the option to review all partial boluses in the history log.

[0087] It will be understood that all of the disclosed methods and procedures described herein can be implemented using one or more computer programs, components, and / or program modules. These components may be provided as a series of computer instructions on any conventional computer-readable or machine-readable medium, including volatile or non-volatile memory such as RAM, ROM, flash memory, magnetic or optical disks, optical memory, or other storage media. The instructions may be provided as software or firmware and / or implemented in whole or in part in hardware components such as ASICs, FPGAs, DSPs, or any other similar devices. The instructions may be configured to be executed by one or more processors, which, when executing the series of computer instructions, perform or facilitate the execution of all or a portion of the disclosed methods and procedures. As will be understood by those skilled in the art, the functionality of the program modules may be combined or distributed as desired in various aspects of the present disclosure.

[0088] While the present disclosure has been described in certain aspects, many additional modifications and variations will be apparent to those skilled in the art. In particular, any of the various processes described above can be performed in alternate sequences and / or in parallel (on the same or different computing devices) to achieve similar results in a manner more suited to the requirements of a particular application. It should therefore be understood that the present disclosure can be implemented in ways other than those specifically described without departing from the scope and spirit of the present disclosure. The embodiments of the present disclosure are therefore to be considered in all respects as illustrative and not restrictive. It will be apparent to those skilled in the art to freely combine any or all of the embodiments discussed herein as deemed suitable for a particular application of the present disclosure. Throughout this disclosure, terms such as "advantageous," "exemplary," or "preferred" refer to elements or dimensions particularly suited (but not essential) to the present disclosure or its embodiments and, except where explicitly required, may be modified whenever deemed suitable by those skilled in the art. The scope of the present invention should therefore be determined not by the exemplified embodiments, but by the appended claims and their equivalents.

Claims

1. 1. A computer-implemented method comprising: storing in a memory of the pump a programmed dose of fluid from the fluid source to be administered in response to a request from an operator; When the request to dispense the programmed dose is received at the pump controller, the pump, via the controller, initiating the dispensing of the programmed dose of the fluid from the fluid source; receiving an indication that the pump has stopped pumping; determining a partial dose equal to the difference in volume between the programmed dose and the volume of the fluid actually dispensed from the fluid source; repeating in response to a subsequent request from the patient when a programmed lockout period has elapsed when the partial dose is equal to zero; generating an alarm that the fluid source is depleted when the partial dose is equal to a value greater than zero, and recording the difference in volume between the programmed dose and the volume of the fluid dispensed from the fluid source in a history log stored in the memory; providing a prompt to replace the depleted fluid source with a subsequent fluid source in response to the alarm that the fluid source is depleted; dispensing the partial dose from the subsequent fluid source after receiving an indication that the subsequent fluid source is fluidly coupled to the pump; and preventing any subsequent dispensing of fluid from said subsequent fluid source for said programmed lockout period. and 11. A computer-implemented method comprising:

2. The computer-implemented method of claim 1 , wherein the fluid source and the subsequent fluid source comprise the same fluid.

3. The computer-implemented method of claim 2 , wherein the fluid source and the subsequent fluid source are contained in syringes configured to engage the pump.

4. The computer-implemented method of claim 2 , wherein the fluid source and the subsequent fluid source contain a pain reliever.

5. 2. The computer-implemented method of claim 1, wherein the controller of the pump is configured to instruct the pump to repeat the method in response to a subsequent request from the patient when the programmed lockout period has elapsed.

6. The computer-implemented method of claim 1 , further comprising displaying information about the dispensing of fluid over a period of time.

7. The computer-implemented method of claim 6 , wherein the displayed information includes information from the history log.

8. 10. The computer-implemented method of claim 1, further comprising automatically replacing the fluid source with another fluid source comprising the same fluid in response to the alarm indicating that the fluid source is depleted.

9. 1. An infusion pump device, comprising: a pumping mechanism configured to dispense a programmed dose volume from a fluid source; a memory configured to store the programmed doses and to record a history log; a patient request device; a processor in communication with the pumping mechanism, the memory, and the patient request device; wherein the processor: dispensing the programmed dose from the fluid source upon the patient making a request via the patient request device; determining a partial dose equal to the difference in volume between the programmed dose and the volume actually dispensed from the fluid source; repeating in response to a subsequent request from the patient when the partial dose is equal to zero and a programmed lockout period has elapsed; generating an alarm that the fluid source is depleted when the partial dose is equal to a value greater than zero, and recording the difference in volume between the programmed dose and the volume of fluid actually dispensed in a history log; in response to the generated alarm that the fluid source is depleted, a clinician replaces the depleted fluid source with a subsequent fluid source, and then dispenses the partial dose from the subsequent fluid source; preventing any subsequent dispensing of fluid from said subsequent fluid source for said programmed lockout period; and repeating in response to a subsequent request from the patient when the programmed lockout period has expired.

10. 10. The infusion pump apparatus of claim 9, wherein the fluid source and the subsequent fluid source comprise the same fluid.

11. The infusion pump apparatus of claim 10 , wherein the fluid source and the subsequent fluid source comprise syringes.

12. The infusion pump apparatus of claim 10 , wherein the fluid source and the subsequent fluid source contain an analgesic.

13. 10. The infusion pump apparatus of claim 9, wherein the patient request device is a handheld pendant having a button in operative communication with the processor of the infusion pump apparatus.

14. 10. The infusion pump apparatus of claim 9, wherein the patient request device is a bolus cord in operative communication with the pumping mechanism.

15. 10. The infusion pump device of claim 9, further comprising a display interface that displays information related to the dispensing of fluid over a predetermined period of time.

16. The infusion pump apparatus of claim 15, wherein the displayed information includes information regarding at least one of the fluid source and the subsequent fluid source.

17. 10. The infusion pump apparatus of claim 9, wherein in response to the generated alarm that the fluid source has run out, the processor is further configured to cause the pump to automatically replace the fluid source with the subsequent fluid source.

18. 10. The infusion pump device of claim 9, wherein the partial dose is determined based on at least one input from one or more sensors configured to detect physical and / or environmental conditions.

19. The infusion pump apparatus of claim 9 further comprising a case for providing access to the fluid source.

20. 20. The infusion pump apparatus of claim 19, wherein the case includes a lock to prevent patient access to the fluid source.

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