WO2016204879A1

WO2016204879A1 - Fluid delivery monitoring system

Info

Publication number: WO2016204879A1
Application number: PCT/US2016/030998
Authority: WO
Inventors: Christopher Gregory; Geoffrey Jenkins
Original assignee: Valeritas, Inc.
Priority date: 2015-06-19
Filing date: 2016-05-05
Publication date: 2016-12-22

Abstract

In some embodiments, there is a fluid delivery monitoring system configured to detect fluid delivery to a patient and generate fluid delivery data for display to a patient or primary caregiver. In some embodiments, fluid delivery monitoring system includes a fluid delivery device and a monitoring device. The fluid delivery device may include one or more sensors configured to detect fluid delivery actions (e.g., deployment of a needle) and generate a fluid delivery signal. The fluid delivery device may also include a fluid delivery tracking module coupled to the one or more sensors and configured to receive the fluid delivery signal and generate and transmit fluid delivery data to the monitoring device. The monitoring device receives fluid delivery data from the fluid delivery tracking module and generates fluid delivery historical data for display to the patient or primary caregiver.

Description

TITLE OF THE INVENTION

[0001] Fluid Delivery Monitoring System

CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Patent Application No.

62/182,115 filed June 19, 2015 entitled "Fluid Delivery Monitoring System", incorporated by reference herein in its entirety.

BACKGROUND OF THE INVENTION

[0003] The present invention generally relates to a monitoring system for medical devices and, more particularly, a fluid delivery monitoring system for fluid delivery devices.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0004] The following detailed description of embodiments of the fluid delivery monitoring system for fluid delivery devices will be better understood when read in conjunction with the appended drawings of an exemplary embodiment. It should be understood, however, that the invention is not limited to the precise arrangements and instrumentalities shown.

[0005] In the drawings:

[0006] Fig. 1 is a trimetric view of a fluid delivery device;

[0007] Fig. 2 is a top cross sectional view of the fluid delivery device shown in Fig. 1 taken along a plane, the location and direction being indicated by line 2-2;

[0008] Fig. 3 A is a front cross sectional view of the fluid delivery device shown in Fig. 1 taken along a plane, the location and direction being indicated by line 3 A-3 A;

[0009] Fig. 3B is a front cross sectional view of the fluid delivery device of Fig. 3 A shown in the deployed position;

[0010] Fig. 4 is a schematic diagram of an exemplary fluid delivery monitoring system for monitoring and tracking fluid delivery amounts according to at least one embodiment of the invention;

[0011] Fig. 5 is a flow chart of a method for monitoring and tracking fluid delivery amounts according to at least one embodiment of the invention; and [0012] Fig. 6 is a diagram of an exemplary computer system that may be used to carry out the methods of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

[0013] Referring to the drawings in detail, wherein like reference numerals indicate like elements throughout, there is shown in Figs. 1-6 a fluid delivery monitoring system and method, generally designated as 400 and 500, respectively, in accordance with an exemplary embodiment of the present invention.

[0014] Electronic fluid delivery systems having sensors and feedback loops for controlling and monitoring fluid delivery are generally known. However, it may be desirable to monitor a fluid delivery device by sensing when one or more actuators of the device are actuated and using that data to remotely calculate how much fluid was delivered as a result. Such a monitoring device may be particularly useful in a low cost disposable fluid delivery device where the basal amount and/or bolus rate may be fixed (e.g., a purely mechanical or hydraulic ambulatory delivery device) such that the monitoring system only needs to indicate when the basal and/or bolus mechanism(s) is actuated. In some embodiments, described herein, the monitoring system may allow for monitoring an otherwise mechanical or non-electronic one use disposable fluid delivery device. In other embodiments, the monitoring system disclosed herein may be used with an electronically driven fluid delivery device. In some embodiments, the monitoring system allows for monitoring of the fluid delivery device by sensing and sending actuator counts without sending measurements or fluid delivery control commands to or from the fluid delivery device.

[0015] In some embodiments, fluid delivery monitoring system 400 is configured to detect fluid delivery to a patient and generate fluid delivery data for display to a patient or primary caregiver. In some embodiments, fluid delivery monitoring system includes a fluid delivery device and a monitoring device. The fluid delivery device may include one or more sensors configured to detect fluid delivery actions (e.g., deployment of a needle) and generate a fluid delivery signal. The fluid delivery device may also include a fluid delivery tracking module configured to receive the fluid delivery signal and generate and transmit fluid delivery data to the monitoring device. The monitoring device may receive the fluid delivery data from the fluid delivery tracking module and generate fluid delivery historical data (e.g., drug delivery data) for display to the patient or primary caregiver.

[0016] Referring to Figs. 1-3B, an exemplary fluid delivery device 110 is shown. In one embodiment, fluid delivery device 110 is a discrete ambulatory insulin delivery pump. Fluid delivery device 110 may be single use, disposable and incapable of reuse. Fluid delivery device 110 may provide therapeutic capability in a small, single use, disposable package and can be produced using high volume manufacturing fabrication (e.g., injection molding) and assembly processes, allowing for low cost of goods. Devices of the invention can be used for a broad range of applications, including, but not limited to, clinical applications (e.g., administration of medicaments, etc.) and biomedical research (e.g., microinjection into cells, nuclear or organelle transplantation, isolation of single cells or hybridomas, etc.).

[0017] In one embodiment, fluid delivery device 110 is a device for dispensing, delivering, or administering the fluid or agent to the user or patient. The fluid may be a low viscosity gel agent and or a therapeutic agent. In one embodiment, the fluid is an analgesic agent. In one embodiment, the fluid is insulin of any type. In one embodiment, the fluid is a U100 insulin. In another embodiment the fluid is a U200 insulin. In another embodiment the fluid is a U300 insulin. In another embodiment, the fluid is a U500 insulin. In another embodiment the fluid is any insulin between U100 and U500. In other embodiments, the fluid may be, but is not limited to, opiates and/or other palliatives or analgesics, hormones, psychotropic therapeutic compositions, or any other drug or chemical whose continuous dosing is desirable or efficacious for use in treating patients. Single fluids and combinations of two or more fluids (admixed or co-administered) may be delivered using fluid delivery device 110. As used herein "patients" or "user" can be human or non- human animals; the use of fluid delivery device 110 is not confined solely to human medicine, but can be equally applied to veterinarian medicine.

[0018] Fluid delivery device 110 may dispense the fluid over a sustained period of time (i.e., basal delivery). In one embodiment, the fluid delivery rate is continuously or near continuously delivered to the user over the sustained period of time.

[0019] Fluid delivery device 110 may also be capable of dispensing a supplementary amount of fluid, in addition to the basal amount, on demand, under patient control (i.e., bolus delivery). In one embodiment, the bolus amount delivered in a single, selectable administration is pre-determined. In preferred embodiments, fluid delivery device 110 is hydraulically actuated. In these embodiments, fluid deliver device 110 comprises one or more reservoirs or chambers containing hydraulic fluid of a suitable viscosity for transferring power from one or more actuators to the fluid and controlling the delivery rate as discussed further below.

[0020] Referring to Fig. 1, for example, the fluid delivery device 110 shown includes a housing 112 and an adhesive bottom surface 114 such as a foam pad.

[0021] Referring to Fig. 2, fluid delivery device 110 may include a cartridge 222 having a fluid reservoir 220 containing the medicament. In some embodiments, fluid delivery device 110 may be configured to receive a pre-filled cartridge. In some embodiments, the fluid reservoir 220 is sealed at one end by movable piston 224 and is sealed at another end by a pierceable septum 218. The fluid delivery device 110 may include one or more actuators 226 (such as a basal actuator), 228 (such as a bolus actuator) that act on movable piston 224 within cartridge 222.

[0022] In one embodiment, fluid delivery device 110 includes a drive including a basal actuator 226 configured to move piston 224 at a controlled predetermined rate. In some embodiments, piston 224 is configured to move at a predetermined rate under the influence of a drive fluid that is stored within a drive fluid reservoir within or part of housing 112. In one embodiment, fluid delivery device 110 includes a drive including a bolus actuator 228 configured to move piston 224 at a rate controlled by the patient. Referring to Figs. 3A and 3B, a needle 330 (e.g., a hollow needle) may be deployed to fluidly couple or interconnect fluid reservoir 220 and the patient's tissue. Needle 330 may be coupled to a button 332 and the needle 330 may be bent such that a translation of button 332 toward the patient causes a fluid coupling end 330a to be fluidly coupled to fluid reservoir 220 and a delivery end 330b to extend from bottom surface 114.

[0023] In some embodiments, fluid delivery device 110 is configured to couple a basal delivery sensor and/or a fluid delivery tracking module (described in more detail below) to a power source (e.g., a battery) via first and second electrical contacts when fluid delivery device 110 initiates fluid delivery. In these embodiments, the first electrical contact may be coupled to a power source (e.g., a battery). The second electrical contact may be coupled to the basal delivery sensor and/or the fluid delivery tracking module. In some embodiments, fluid delivery device 110 includes i) needle 330 that fluidly interconnects fluid reservoir 220 and the patient's tissue or ii) a compressed spring configured to place drive fluid under pressure when released. When needle 330 is deployed or the compressed spring is released, the first and second contacts may be coupled to each other, thereby coupling basal delivery sensor and/or a fluid delivery tracking module to the battery. In some embodiments, an electrical signal is transmitted from the power source to the basal delivery sensor when the spring releases. This electrical signal indicates that a user initiated basal delivery. In some embodiments, an electrical signal is transmitted from the power source to the fluid delivery tracking module to activate the fluid delivery tracking module.

[0024] In some embodiments, basal delivery sensor, bolus delivery sensor and/or fluid delivery tracking module is secured or sealed within housing 112. Such a configuration may help to prevent tampering of the fluid delivery device 110.

[0025] Medicament delivery systems as described above may be used to deliver drugs to manage medical conditions. The drug delivery by the device may be initiated by the user and may or may not involve active ongoing control by the patient such as bolus delivery by user action. Keeping track of the amount and timing of the delivery can be beneficial to the management of the disease state. In addition, drug delivery devices are often used in conjunction with other devices or monitoring techniques to ensure proper management of the disease state or symptoms. These monitors may measure the amount of the medicament available in the body or some biometric value that is affected directly or indirectly by the medicament. An example would be blood glucose when the medicament delivered is insulin, GLP-1 or other injectable blood glucose controlling drug. There would be benefit in being able to automatically track the time and amount of medicament delivery would be beneficial.

[0026] Fluid delivery device 110 may be configured to be very accurate in its delivery of basal levels of medicament. Tracking the delivery of the basal medicament may therefore only require knowing when the delivery was initiated. Thus recording and tracking the time of the initiation of the use of the fluid delivery device 110 may be sufficient for monitoring fluid delivery amounts. A number of actions can be used to trigger the time of initiation including; the deployment of the needle, the removal of the spring retaining pin, the pressurization of either of the hydraulic chambers, motion of the hydraulic or medicinal pistons, removal of the skin adhesive release liner or any other action required to execute the aforementioned actions. Any of these actions can be used to trigger an electronic sensor or trigger that is directly or indirectly attached to any of the components involved in these actions. By monitoring these actions, a user can determine the amount of fluid delivery provided by fluid delivery device 110.

[0027] Fig. 4 is a conceptual diagram of an exemplary fluid delivery monitoring system for monitoring and tracking fluid delivery amounts according to at least one embodiment of the invention. In Fig. 4, exemplary fluid delivery monitoring system 400 comprises fluid delivery device 110 and a monitoring device 420.

[0028] The fluid delivery device 110 may include one or more sensors. A sensor may be any device that detects a fluid delivery action (e.g., deployment of needle) by a fluid delivery actuator and generates a fluid delivery signal indicating that a fluid delivery action occurred. Examples of fluid delivery actuators include needle buttons, springs, drive pistons, hydraulic fluid, and medicinal pistons. Examples of sensors include: i) an optical sensor that detects fluid delivery actuator motion such as needle deployment, ii) a pressure sensor that detects pressure in the hydraulic system or pressure from a button press and iii) electrical contacts that connect or disconnect when a fluid delivery actuator moves from one position to another, among others. This is unlike systems which measure fluid flow or take data from electronic control systems of fluid delivery devices. [0029] In the exemplary embodiment of Fig. 4, fluid delivery device 110 includes a basal delivery sensor 402 and a bolus delivery sensor 403. A basal delivery sensor 402 detects when fluid delivery device 110 performs basal delivery of a fluid. In one embodiment, the basal delivery sensor 402 includes electrical contacts that couple the basal delivery sensor 402 to a power source when basal delivery is initiated, as described above. In one embodiment, the basal delivery sensor 402 is an optical sensor that detects movement of a part of fluid delivery device 110, such as a needle button, needle spring retention pin, hydraulic or medicinal piston. A bolus delivery sensor 403 detects when fluid delivery device 110 performs bolus delivery of a fluid. In one embodiment, the bolus delivery sensor 403 includes an optical sensor that optically detects a bolus delivery when bolus actuator 228, configured to initiate a bolus delivery, moves from a first position to a second position. In one embodiment, the bolus delivery sensor 403 includes a pressure sensor that detects a bolus delivery when bolus actuator 228, configured to initiate a bolus delivery, applies force to the pressure sensor.

[0030] In some embodiments, fluid delivery device 110 includes a fluid delivery tracking module 410 coupled to basal delivery sensor 402 and/or bolus delivery sensor 403. Fluid delivery tracking module 410 may be any device configured to receive a fluid delivery signal from a sensor, generate fluid delivery data (e.g., basal delivery data and/or bolus delivery data), and transmit the fluid delivery data to monitoring device 420.

[0031] Monitoring device 420 may be any computing device configured to receive fluid delivery data from fluid delivery tracking module 410, process the fluid delivery data and generate fluid delivery historical data for display. Examples of monitoring devices include computer servers, personal computers, laptops, tablets, monitors (e.g., handheld), smart phones, wearable devices such as glasses, watches, bracelets and necklaces, and personal digital assistants, among others.

[0032] In some embodiments, monitoring device 420, or a device in communication with monitoring device 420, is configured to calculate total basal delivery. In one embodiment, total basal delivery equals a basal delivery time multiplied by a basal delivery rate. Basal delivery time may be based on an amount of time that fluid delivery device 110 performs basal delivery. Basal delivery rate may be based on a rate at which fluid delivery device 110 delivers fluid to the patient.

[0033] In some embodiments, monitoring device 420 is configured to calculate total bolus delivery. In one embodiment, total bolus delivery equals a number of bolus deliveries multiplied by fluid amount delivered per bolus delivery. The number of bolus deliveries may be based on the number of times fluid delivery device 110 performed a bolus delivery after basal delivery is initiated. The fluid amount delivered per bolus delivery may be based on a predetermined amount of fluid supplied by fluid delivery device 110 when fluid delivery device 110 performs a bolus delivery.

[0034] In one embodiment, monitoring device 420 is configured to display historical fluid delivery data (e.g., total basal delivery or total bolus delivery) such as a history of insulin delivery for the device.

[0035] In one embodiment, monitoring device 420 is configured to use historical fluid delivery data in conjunction with supplemental data provided from other devices or entered manually by a user via a user interface to calculate the body response of the patient to the medicament. Examples of the supplemental data may include blood glucose level of the patient and food consumption of the patient. The monitoring device 420 can compare the glucose level in the blood with the delivery history of the drug. Combined with the history of food consumption, the monitoring device 420 can calculate and communicate, to the user or clinician, the body response to the drug. In one embodiment, monitoring device 420 is configured to provide recommendations on the user's initiation of subsequent bolus deliveries using supplemental data, such as the body response to the drug and/or the amount of food consumed by the patient, among others. For example, if the body response to the insulin is strong, then the monitoring device 420 may recommend a lower number of boluses for a specified food quantity or type.

[0036] In one embodiment, monitoring device 420 is configured to transmit historical fluid delivery data to the patient's caregiver for analysis or monitoring.

[0037] Fig. 5 is a flow chart of a method 500 for monitoring and tracking fluid delivery amounts according to at least one embodiment of the invention.

[0038] At step 501, fluid delivery device 110 initiates basal delivery to a patient in response to a user activation of the device for basal delivery. In one embodiment, fluid delivery device 110 deploys needle 330 that fluidly couples or interconnects fluid reservoir 220 and the patient's tissue to initiate basal delivery. When fluid delivery device 110 deploys needle 330, needle 330 connects a pair of contacts and couples a power source to fluid delivery tracking module 410, as explained above.

[0039] At step 502, fluid delivery device 110 activates fluid delivery tracking module 410 at initiation of basal delivery. In one embodiment, fluid delivery tracking module 410 is activated using power from a power source when deployed needle 330 connects the power source to fluid delivery tracking module 410.

[0040] Fluid delivery tracking module 410 may track basal delivery time using a number of different methods. For example, in some embodiments, fluid delivery tracking module 410 records, in memory, a basal delivery start timestamp indicating when the fluid delivery device 110 initiated basal delivery of the fluid. In addition, in some embodiments, fluid delivery tracking module 410 records, in memory, a basal delivery stop timestamp indicating when the fluid delivery device 110 ceased basal delivery of the fluid. In some embodiments, fluid delivery tracking module 410 does not maintain a clock of real time but implements a basal delivery counter that increments. A current count of the basal delivery counter indicates an amount of time that the fluid delivery device 110 has been supplying basal delivery by incrementing every predetermined amount of time (e.g., every second). The basal delivery counter starts when the fluid delivery device 110 begins basal delivery and stops when the fluid delivery device 110 ceases basal delivery. As explained below, monitoring device 420 may be configured to use the basal delivery time tracked by fluid delivery tracking module 410 to calculate the actual time of basal delivery start and or total basal delivery.

[0041] At step 503, fluid delivery tracking module 410 may generate and transmit basal delivery data to monitoring device 420. The basal delivery data may include information indicating when the basal fluid delivery by the fluid delivery device 110. In some embodiments, the basal delivery data includes at least one of: the basal delivery start timestamp, the basal delivery stop timestamp, the current count of the basal delivery counter, and the predetermined basal delivery rate. In some embodiments, the basal delivery data includes a fluid delivery device identifier is a unique identifier that distinguishes fluid delivery device 110 from other fluid delivery devices so that monitoring device 420 can calculate fluid delivery historical data using only fluid delivery data for fluid delivery device 110. In some embodiments, the fluid delivery device identifier indicates a model type of fluid delivery device 110 indicating the predetermined basal flow rate. As explained below, monitoring device 420 may be configured to use this data to compute total basal delivery.

[0042] In some embodiments, fluid delivery tracking module 410 may have an intermittent connection with monitoring device 420 after fluid delivery tracking module 410 initiates basal delivery. In these embodiments, fluid delivery tracking module 410 periodically retransmits basal delivery data to monitoring device 420. Monitoring device 420 may be configured to transmit a receipt acknowledgement to fluid delivery tracking module 410 when monitoring device 420 receives fluid delivery device identifier and/or basal delivery data. Fluid delivery tracking module 410 may be configured to cease retransmitting basal delivery data after receiving the receipt acknowledgement from monitoring device 420.

[0043] At step 504, monitoring device 420 may receive the basal delivery data from fluid delivery tracking module 410. In some embodiments, monitoring device 420 records, in memory, data included with the basal delivery data including any of: the basal delivery start timestamp, the basal delivery stop timestamp, a value of the basal delivery counter, a basal delivery rate and the fluid delivery device identifier.

[0044] At step 505, monitoring device 420 may calculate total basal delivery based on at least the basal delivery data received from fluid delivery tracking module 410. As described above, total basal delivery equals a basal delivery time multiplied by a basal delivery rate. Basal delivery time may be based on an amount of time that fluid delivery device 110 performs basal delivery. In some embodiments, monitoring device 420 sets the basal delivery time as a time difference between the basal delivery start timestamp and one of: the basal delivery stop timestamp or a current time if basal delivery is still occurring. In some embodiments, monitoring device 420 sets the basal delivery time as the current count of the basal delivery counter. Basal delivery rate may be based on a rate at which fluid delivery device 110 delivers fluid to the patient. In some embodiments monitoring device 420 sets the basal deliver rate as the basal delivery rate specified in the basal delivery data. In some embodiments, monitoring device 420 sets the basal deliver rate as a basal delivery rate preconfigured in memory of monitoring device 420. For example, monitoring device 420 may be configured to store an association between a model type of a fluid delivery device and basal flow rate in memory. In embodiments where monitoring device 420 receive a model type of fluid deliver device 110 or a fluid delivery device identifier, monitoring device 420 may be configured to calculate total basal delivery using the basal flow rate associated with the model type or fluid delivery device identifier of fluid delivery device 110 stored in memory.

[0045] At step 506, fluid delivery device 110 may initiate bolus delivery in response to a user request for bolus delivery (e.g., a user actuating bolus actuator 228).

[0046] At step 507, bolus delivery sensor 403 detects that fluid deliver device 110 initiated bolus delivery. In some embodiments, fluid delivery tracking module 410 records a bolus count in memory of fluid delivery tracking module 410 indicating a number of times that fluid delivery device 110 initiates bolus delivery. Each time fluid delivery device 110 initiates a bolus delivery, fluid delivery tracking module 410 may increment the bolus count. Fluid delivery tracking module 410 may also record the incremented bolus count, along with a bolus delivery timestamp indicating when the fluid delivery device 110 performed bolus delivery, in memory of fluid delivery tracking module 410.

[0047] At step 508, fluid delivery tracking module 410 may generate and transmits bolus delivery data to monitoring device 420. In some embodiments, the bolus delivery data includes at least one of: the fluid delivery device identifier, the bolus delivery timestamp, the bolus count, and a fluid amount delivered per bolus delivery. As explained below, monitoring device 420 may be configured to use the data associated with the bolus delivery data (e.g., bolus count) to compute total basal delivery.

[0048] In some embodiments, fluid delivery tracking module 410 may have an intermittent connection with monitoring device 420 after fluid delivery device 110 initiates bolus delivery. In these embodiments, fluid delivery tracking module 410 periodically retransmits bolus delivery data to monitoring device 420. Monitoring device 420 may be configured to transmit a receipt acknowledgement to fluid delivery tracking module 410 when monitoring device 420 receives bolus delivery data. Fluid delivery tracking module 410 may cease retransmitting bolus delivery data after receiving the receipt acknowledgement from monitoring device 420.

[0049] In some embodiments, fluid delivery tracking module 410 may transmit data in response to a request for data from monitoring device 420.

[0050] At step 509, monitoring device 420 may receive the bolus delivery data from fluid delivery tracking module 410. Monitoring device 420 may then record, in memory, the data included with the bolus delivery data including any of: the fluid delivery device identifier, the bolus delivery timestamp, bolus count, and the fluid amount delivered per bolus delivery.

[0051] At step 510, monitoring device 420 may calculate total bolus delivery based on the bolus delivery data received from fluid delivery tracking module 410. Total bolus delivery may equal a number of bolus deliveries multiplied by fluid amount delivered per bolus delivery. The number of bolus deliveries may be based on the number of times fluid delivery device 110 performed a bolus delivery after an initial basal delivery. In some embodiments, monitoring device 420 sets the number of bolus deliveries as equal to the bolus count specified in the bolus delivery data. The fluid amount delivered per bolus delivery may be based on a predetermined amount of fluid supplied by fluid delivery device 110 when fluid delivery device 110 performs a bolus delivery. In some embodiments, monitoring device 420 sets the fluid amount delivered per bolus delivery as the fluid amount per bolus delivery specified in the bolus delivery data. In some embodiments, monitoring device 420 sets the fluid amount per bolus delivery as a fluid amount per bolus delivery

preconfigured in memory of monitoring device 420. In some embodiments, monitoring device 420 may be configured to store an association between a model type of a fluid delivery device and fluid amount per bolus delivery in memory. In embodiments where monitoring device 420 receive a model type of fluid deliver device 110 or the fluid delivery device identifier, monitoring device 420 may be configured to calculate total bolus delivery using the fluid amount per bolus delivery associated with the model type of fluid delivery device 110 or the fluid delivery device identifier stored in memory. [0052] At step 511, monitoring device 420 may display historical fluid delivery data (e.g., drug delivery data) on a user interface (e.g., a user display). Historical fluid delivery data may include total basal delivery, total bolus delivery, each basal delivery start timestamp, each basal delivery stop timestamp, a current count of the basal delivery counter, a basal delivery rate, each bolus delivery timestamp, a bolus count, and a fluid amount delivered per bolus delivery.

[0053] Fig. 6 is a diagram of an exemplary computer system 600 that may be used to carry out the methods of the present invention. Methods of the present invention, described herein, may be implemented as programmable code for execution by computer system 600. More particularly, computer system 600 may be implemented as fluid delivery tracking module 410 and/or monitoring device 420. Computer system 600 comprises hardware, as described more fully herein, which is used in connection with executing software/computer programming code (i.e., computer readable instructions) to carry out the steps of the methods described herein.

[0054] Computer system 600 includes one or more processors 612. Processor 612 may be any type of processor, including but not limited to a special purpose or a general-purpose digital signal processor. Processor 612 may be connected to a communication infrastructure 611 (e.g. a data bus or computer network) either via a wired connection or a wireless connection. Communication infrastructure 611 carries signals and may be implemented using wire or cable, fiber optics, a phone line, a wireless link, a cellular phone link, a radio frequency link, or any other suitable

communication channel, including a combination of the foregoing exemplary channels.

[0055] Computer system 600 may include one or more memories 613. Memory 613 may include at least one of: random access memory (RAM), a hard disk drive and a removable storage drive, such as a floppy disk drive, a magnetic tape drive, or an optical disk drive. The removable storage drive reads from and/or writes to a removable storage unit. The removable storage unit can be a floppy disk, a magnetic tape, an optical disk, which is read by and written to a removable storage drive.

[0056] In alternative implementations, memory 613 may include other similar means for allowing computer programs or other instructions to be loaded into computer system 600. Such means may include, for example, a removable storage unit and an interface. Examples of such means may include a removable memory chip (such as an EPROM, or PROM, or flash memory) and associated socket, and other removable storage units and interfaces which allow software and data to be transferred from removable storage unit to computer system 600. Alternatively, the program may be executed and/or the data accessed from the removable storage unit, using the processor 612 of the computer system 600. [0057] Computer system 600 may include one or more user interfaces 614. User interface 614 may be a program that controls a display (not shown) of computer system 600, on which the output of the processes described herein can be displayed. User interface 614 may include one or more peripheral user interface components, such as a keyboard or a mouse. An end user may use the peripheral user interface components to interact with computer system 600. User interface 614 may receive user inputs, such as mouse inputs or keyboard inputs from the mouse or keyboard user interface components.

[0058] Computer system 600 may also include a communication interface 615. Communication interface 615 is configured to transfer and receive data between computer system 600 (e.g., fluid delivery tracking module 410 or monitoring device 420) and an external device (e.g., the other of fluid delivery tracking module 410 or monitoring device 420). Examples of communication interface 615 may include a modem, a network interface (such as an Ethernet card), a

communication port, an acoustic interface, a radio frequency (RF) interface, an infrared (IR) interface and a tissue conductance interface (e.g., an electrical link through a patient's body), among others. The communication interface may use different communication protocols to transmit data to an external device. Examples of the communication protocols include Wi-Fi and Bluetooth, among others. Data transferred via communication interface 615 are in the form of signals, which may be electronic, electromagnetic, optical, or other signals capable of being received by communication interface 615. Signals generated by processor 612 of computer system 600 are provided to communication interface 615 via a communication infrastructure 611.

[0059] In at least one embodiment, there is included one or more computers having one or more processors and memory (e.g., one or more nonvolatile storage devices). In some embodiments, memory or computer readable storage medium of memory stores programs, modules and data structures, or a subset thereof for a processor to control and run the various systems and methods disclosed herein. In one embodiment, a non-transitory computer readable storage medium having stored thereon computer-executable instructions which, when executed by a processor, perform one or more of the methods disclosed herein.

[0060] It will be appreciated by those skilled in the art that changes could be made to the exemplary embodiments shown and described above without departing from the broad inventive concepts thereof. It is understood, therefore, that this invention is not limited to the exemplary embodiments shown and described, but it is intended to cover modifications within the spirit and scope of the present invention as defined by the claims. For example, specific features of the exemplary embodiments may or may not be part of the claimed invention and various features of the disclosed embodiments may be combined. Unless specifically set forth herein, the terms "a", "an" and "the" are not limited to one element but instead should be read as meaning "at least one."

[0061] It is to be understood that at least some of the figures and descriptions of the invention have been simplified to focus on elements that are relevant for a clear understanding of the invention, while eliminating, for purposes of clarity, other elements that those of ordinary skill in the art will appreciate may also comprise a portion of the invention. However, because such elements are well known in the art, and because they do not necessarily facilitate a better understanding of the invention, a description of such elements is not provided herein.

[0062] Further, to the extent that the methods of the present invention do not rely on the particular order of steps set forth herein, the particular order of the steps should not be construed as a limitation on the claims. Any claims directed to the methods of the present invention should not be limited to the performance of their steps in the order written, and one skilled in the art can readily appreciate that the steps may be varied and still remain within the spirit and scope of the present invention.

Claims

CLAIMS I/we claim:

1. A fluid delivery monitoring system, comprising: a fluid delivery device configured to deliver fluid to a tissue of a user, the fluid delivery device including: a fluid reservoir containing the fluid; a needle configured to fluidly interconnect the fluid reservoir and the tissue of the user when fluid delivery is initiated; at least one actuator configured to urge the fluid from the fluid reservoir; a sensor configured to detect activation and/or movement of the at least one actuator and generate a fluid delivery signal; and a fluid delivery tracking module configured to receive the fluid delivery signal, generate fluid delivery data, and transmit the fluid delivery data to a monitoring device.

2. The fluid delivery monitoring system of claim 1 further comprising the monitoring device, wherein the monitoring device is configured to: receive the fluid delivery data from the fluid delivery tracking module; calculate fluid delivery historical data based on the fluid delivery data; and display the fluid delivery historical data.

3. The fluid delivery monitoring system of claim 2, wherein the fluid delivery historical data includes total basal delivery data.

4. The fluid delivery monitoring system of claim 3, wherein the total basal delivery data equals a basal delivery time multiplied by a basal delivery rate.

5. The fluid delivery monitoring system of claim 2, wherein the fluid delivery historical data includes total bolus delivery data.

6. The fluid delivery monitoring system of claim 5, wherein the total bolus delivery data equals a number of bolus deliveries multiplied by fluid amount delivered per bolus delivery.

7. The fluid delivery monitoring system of claim 1, wherein the sensor includes a basal delivery sensor.

8. The fluid delivery monitoring system of claim 7, wherein the basal delivery sensor includes first and second contacts, the first contact being couplable to the fluid delivery tracking module, the second contact being couplable to a power source, the basal delivery sensor being configured to detect that fluid delivery is initiated when the first contact couples to the second contact.

9. The fluid delivery monitoring system of claim 8, wherein the fluid delivery tracking module activates when the basal delivery sensor detects that at least one of: a needle and a compressed spring of the fluid delivery device is deployed to initiate fluid delivery, causing the first contact to couple the second contact.

10. The fluid delivery monitoring system of claim 1, wherein the fluid delivery data includes bolus delivery data.

11. The fluid delivery monitoring system of claim 10, wherein the bolus delivery data includes at least one of: a value representing a number of bolus deliveries, a fluid amount delivered per bolus delivery, and a timestamp of each bolus delivery.

12. The fluid delivery monitoring system of claim 1, wherein the at least one actuator includes a basal actuator.

13. The fluid delivery monitoring system of claim 1, wherein the at least one actuator includes a bolus actuator.

14. The fluid delivery monitoring system of claim 1, wherein the fluid delivery data includes at least one of: basal delivery time and basal delivery rate.

15. The fluid delivery monitoring system of claim 1, wherein the fluid delivery tracking module include a counter having a current count, the counter configured to initialize when fluid delivery is initiated and increment after a predetermined amount of time, and wherein the fluid delivery data includes the current count of the counter.

16. The fluid delivery monitoring system of claim 1, wherein the sensor includes a bolus delivery sensor.

17. The fluid delivery monitoring system of claim 1, wherein the at least one actuator includes a button.

18. The fluid delivery monitoring system of claim 1, wherein the at least one actuator includes a spring.

19. The fluid delivery monitoring system of claim 1, wherein the at least one actuator includes a drive piston.

20. The fluid delivery monitoring system of claim 1, wherein the at least one actuator includes hydraulic fluid.

21. The fluid delivery monitoring system of claim 1, wherein the at least one actuator includes a medicinal piston.

22. The fluid delivery monitoring system of claim 1, wherein the sensor is an optical sensor that detects motion of the actuator.

23. The fluid delivery monitoring system of claim 1, wherein the sensor is a pressure sensor that detects pressure caused by the actuator.

24. The fluid delivery monitoring system of claim 1, wherein the sensor includes electrical contacts that detect actuator movement by connecting or disconnecting when the actuator moves.

25. The fluid delivery monitoring system of claim 1, wherein the at least one actuator is configured to urge the fluid from the reservoir at a predetermined rate.