Infusion pump methods and systems

Abstract

To provide infusion pump methods and systems.SOLUTION: An infusion pump system is disclosed. The system includes at least one infusion pump, a companion device, the companion device in wireless communication with the infusion pump, and a user interface on the companion device adapted to receive a text input. Also, a medical remote controller device is disclosed. The device includes a display and at least one input switch dedicated to a bolus delivery. The bolus delivery is programmed when the input switch receives an input and the number of inputs received by the input switch determines the amount of bolus to be delivered.SELECTED DRAWING: Figure 3

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application is incorporated herein by reference in its entirety. ices and Systems,Apparatus and Methods T Priority is claimed to "hereof" (filed March 25, 2009) (H21), and The disclosure of which is incorporated herein by reference in its entirety.

[0002] This application also relates to U.S. patent application Ser. No. 12 / 416,662, entitled "Methods and Systems for Controlling an Infusion Pum p," filed April 1, 2009), which is currently U.S. Patent No. US-2009-0254 This application is a continuation-in-part of G98, issued on October 8, 2009, and is incorporated herein by reference. U.S. Provisional Patent Application No. 61 / 165,592 entitled "Methods and Systems" ms for Controlling a Medical Device,” 200 Filed April 1, 1997, (H24)) and U.S. Provisional Patent Application No. 61 / 041,291 (title “Methods and Systems for Controlling a M "Edical Device," filed April 1, 2008, claims priority from (F76) and all of these applications are incorporated herein by reference in their entirety.

[0003] FIELD OF THE INVENTION The present invention relates to infusion pumps, and more particularly to infusion pump methods and systems. do. [Background technology]

[0004] Many potentially valuable drugs or compounds, including biologics, suffer from poor absorption, hepatic metabolism, and It is not effective orally due to side effects or other pharmacokinetic factors. Although the therapeutic compound can be absorbed orally, it may need to be administered frequently. In such cases, it is difficult for patients to maintain the desired schedule. Oral delivery is often employed or can be employed.

[0005] Drug delivery and other fluid and An effective parenteral route of administration of the compounds involves puncturing the skin with a needle or stylet. Insulin is a wearable device that automatically delivers the required drug / compound over a period of time. Millions of users living with diabetes may benefit from parenterally delivered medications. 1 is an example of a therapeutic fluid self-injected by a

[0006] To this end, portable and wearable devices for the controlled release of therapeutic agents are being developed. Efforts have been made to design devices that utilize cartridges, cylinders, and other It is known that the device has a reservoir such as a tube or bag and is electronically controlled. These devices have a number of drawbacks: their size, weight, Reducing production and costs is also an ongoing challenge.

[0007] In addition, many of these devices have a built-in security function between the device and the user, or between the device and the caregiver. It requires frequent and direct interaction between people. Therefore, in these cases, The device is clipped to clothing or a belt, or carried in a pocket. Therefore, it is often desirable to have it accessible under all circumstances. However, this is not always practical or possible. A device that can be controlled by a remote device so that the guardian does not require frequent direct interaction. is desired.

[0008] Furthermore, safety is an ongoing concern for any medical device. Therefore, a system and method that provides additional security to users is desired. Summary of the Invention [Means for solving the problem]

[0009] According to one aspect of the present invention, an infusion pump system is disclosed. The system comprises at least An infusion pump and a companion device that communicates wirelessly with the infusion pump. a companion device; and a user interface on the companion device, and a user interface adapted to receive text input.

[0010] Some embodiments of this aspect of the invention may include one or more of the following: The list entry must have a customized name for at least one base profile. do.

[0011] The text entry includes at least one customized comment. The system includes at least one customized event. a pairing mode for pairing the device with at least one infusion pump, The device further includes a pairing mode that enables wireless communication between the user and the controller device. The interface allows both the infusion pump and the controller to be in paired mode simultaneously. The Companion includes a display. At least one infusion pump The user interface includes a display. at least one alarm setting for the device, the at least one alarm setting comprising: The user interface may be used to select the infusion pump and companion device. At least one alarm setting for the device may be different. The user interface is present on at least one infusion pump. A visual indication of the ongoing bolus delivery, including the total amount requested. When stopped, the user interface further includes an indication of the delivery amount and the total requested amount. , with a visual indication of delivery stop.

[0012] The user interface further displays the loaded insulin and final delivery bolus. The final delivery bolus includes a home screen with a visual indication of the progress since delivery was completed. The time and amount delivered are included.

[0013] According to one aspect of the present invention, a medical remote control device is disclosed. The device includes a display and at least one input switch dedicated to bolus delivery, The class delivery is programmed when the input switch receives an input and is The number of inputs received determines the amount of bolus delivered.

[0014] Some embodiments of this aspect of the invention may include one or more of the following: The spray provides a visual indication of the amount of bolus delivered. Each input represents a pre-programmed amount of bolus to be delivered. The device includes a strip reader. The device includes a jog wheel.

[0015] According to one aspect of the present invention, an infusion pump system is disclosed. The system comprises at least An infusion pump and a companion device that communicates wirelessly with the infusion pump. a companion device and a device for administering a drug to the companion device and at least one infusion pump; A user interface on both the companion device and the infusion pump. and a user interface that is substantially identical.

[0016] Some embodiments of this aspect of the invention may include one or more of the following: The interface is adapted to receive user input regarding insulin delivery volume. User input regarding insulin delivery volume is used to calculate the insulin being loaded. Companion devices include glucose strip readers. The on-device receives a signal transmitted from at least one continuous glucose sensor. The test results from the glucose strip reader are displayed on a user interface. The test results can be viewed using the user interface as a line graph. The most recent test results are displayed in a timely fashion in the user interface. It may be visible on the home screen.

[0017] According to one aspect of the present invention, a companion device for an infusion pump is A method for self-checking the integrity of a display is disclosed. a step of checking the sound, a step of checking the vibrator, and a step of checking the backlight a step of checking the test light; a step of checking the memory; The self-checks are performed at intervals, and the self-checks include Identify faults in one or more of the systems being checked through

[0018] Some embodiments of this aspect of the invention may include one or more of the following: A self-check is performed when the system receives a user command to perform a self-check. can be.

[0019] These aspects of the invention are not meant to be exclusive and should not be construed as limiting other features, aspects, or aspects of the invention. and advantages will become apparent to those skilled in the art when read in conjunction with the appended claims and accompanying drawings. It becomes readily apparent. For example, the present invention provides the following items: (Item 1) 1. An infusion pump system comprising: at least one infusion pump; a companion device in wireless communication with the infusion pump; A chair and a user interface on the companion device for receiving text input; A user interface and 1. An infusion pump system comprising: (Item 2) The text input is customized for at least one base profile. Item 1. The system according to item 1, including a name. (Item 3) The text input includes at least one customized comment. The system described. (Item 4) Item 1, wherein the text input includes at least one customized event. system. (Item 5) The user interface may be configured to connect the companion device to the at least one note. A pairing mode for pairing an infusion pump with one infusion pump and the controller device. The user interface further includes a pairing mode that enables wireless communication between the user interface and the device. The device requires that both the infusion pump and the controller be in the pairing mode simultaneously. Item 1. The system of item 1. (Item 6) Item 10. The system of item 1, wherein the companion includes a display. (Item 7) Item 10. The system of item 1, wherein the at least one infusion pump includes a display. (Item 8) The user interface may include a user interface for the infusion pump and the companion device. at least one alarm setting for the user, The infusion pump and the companion device may be selected using a user interface. Item 1, wherein the at least one alarm setting for the device may be different. Stem. (Item 9) The user interface is present on the at least one infusion pump. 1. The system described in 1. (Item 10) The user interface displays the ongoing bolus delivery, including the amount delivered and the total amount requested. Item 10. The system of item 1, including a visual display of (Item 11) When the bolus delivery is stopped, the user interface displays the delivery amount and 11. The system of claim 10, further comprising a visual indication of delivery stoppage, including an indication of the total required amount. Tem. (Item 12) The user interface displays the status of the loaded insulin and final delivered bolus. and a home screen with a visual display, the final delivery bolus being displayed after delivery is complete. Item 11. The system of item 10, comprising the elapsed time and the delivered amount. (Item 13) 1. A medical remote controller device, comprising: The display and At least one input switch dedicated to bolus delivery, The input switch is programmed when it receives an input, and the input received by the input switch The number of input switches determines the amount of bolus delivered. Including, medical remote controller device. (Item 14) Item 14. The medical device of item 13, wherein the display visually indicates the amount of bolus delivered. Remote controller device. (Item 15) Each input received by the input switch pre-programs a bolus to be delivered. Item 14. The medical remote controller device of item 13, which indicates the amount of data stored. (Item 16) Item 14. The medical remote controller device according to item 13, further comprising a glucose strip reader. Vice. (Item 17) Item 14. The medical remote controller device of item 13, further comprising a jog wheel. (Item 18) 1. An infusion pump system comprising: at least one infusion pump; a companion device in wireless communication with the infusion pump; A chair and a user interface on the companion device and the at least one infusion pump; a substantially identical interface on both the companion device and the infusion pump; The user interface and 1. An infusion pump system comprising: (Item 19) The user interface is adapted to receive user input regarding insulin delivery volume. Item 19. The system according to item 18, adapted to: (Item 20) The user input regarding insulin delivery volume calculates the insulin being loaded Item 19. The system according to item 19, used for: (Item 21) Item 19. The companion device further comprises a glucose strip reader. system. (Item 22) The companion device transmits from at least one continuous glucose sensor. Item 19. The system according to item 18, adapted to receive a signal. (Item 23) Test results from the glucose strip reader can be read using the user interface. Item 21, which can be seen in the system. (Item 24) The test results can be viewed in line graph form using the user interface. Item 24. The system according to item 23, (Item 25) The most recent test results are displayed on the home screen of the user interface. Item 24. The system of item 23, wherein (Item 26) A companion device for an infusion pump is provided that verifies the integrity of the companion device. A method of checking, the method comprising: Check the display and Check the acoustics and Check the vibrator and Check the backlight and Check the test light and Checking the memory the self-checks are performed at intervals, and the self-checks include A method for identifying faults in one or more of the systems being checked through a check. Law. (Item 27) The self-check is performed when the system receives a user command to perform a self-check. 27. The method according to item 26, wherein the method is carried out when [Brief explanation of the drawings]

[0020] These and other features and advantages of the present invention will become more apparent from the following detailed description taken in conjunction with the following drawings. It is better understood by reading it in this way. [Figure 1-1] 1A-1B are front and rear isometric views of one embodiment of an infusion pump assembly. [Figure 1-2] 1C-1E are side and front views of one embodiment of the infusion pump assembly of FIG 1. FIG 1F is a front isometric view of one embodiment of the infusion pump assembly of FIG 1. [Figure 2-1] 2A-2D show various views of an exemplary embodiment of an infusion pump assembly. [Figure 2-2] 2A-2D show various views of an exemplary embodiment of an infusion pump assembly. [Figure 3] FIG. 3 is an illustration of one embodiment of a remote controller or companion assembly. [Figure 4]FIG. 4 is a diagrammatic view of the infusion pump assembly of FIG. [Figure 5] 5A-5C show exemplary embodiments of time and date selection wizard screens according to one embodiment. [Figure 6] FIG. 6 shows an exemplary embodiment of an undo changes confirmation screen. [Figure 7-1] 7A-7C illustrate at least various exemplary embodiments of device pairing screens. [Figure 7-2] 7A-7C illustrate at least various exemplary embodiments of device pairing screens. [Figure 8] 8A-8B show at least exemplary embodiments of various insulin profile screens. [Figure 9] 9A-9B show at least example embodiments of various display screens. [Figure 10-1] 10A-10E show example embodiments of at least various home screens. [Figure 10-2] 10A-10E show example embodiments of at least various home screens. [Figure 11] 11A-11B show at least various exemplary embodiments of 1U drop screens. [Figure 12] FIG. 12 illustrates at least an exemplary embodiment of various fixed item screens. [Figure 13] 13A-13B show at least exemplary embodiments of various warning screens. [Figure 14] 14A-14B show example embodiments of at least various companion alert screens. [Figure 15] FIG. 15 illustrates at least various exemplary embodiments of companion temporary lockouts. [Figure 16] FIG. 16 illustrates at least an exemplary embodiment of various wireless screens. [Figure 17] FIG. 17 illustrates an exemplary embodiment of at least one alarm, reminder, and repairable screen. [Figure 18]18A-18B illustrate example embodiments of at least various reminder and downtime setting screens, according to an example embodiment. [Figure 19-1] 19A-19E show at least example embodiments of various alarm screens. [Figure 19-2] 19A-19E show at least example embodiments of various alarm screens. [Figure 20-1] 20A-20I show at least example embodiments of various alert screens. [Figure 20-2] 20A-20I show at least example embodiments of various alert screens. [Figure 20-3] 20A-20I show at least exemplary embodiments of various alert screens. [Figure 21] 21A-21B show at least exemplary embodiments of various reminder screens. [Figure 22] FIG. 22 illustrates an exemplary embodiment of at least various screens for setting the frequency of site change care comments. [Figure 23] 23A-23B show at least exemplary embodiments of various bolus screens. [Figure 24] 24A-24D show example embodiments of at least various warning and confirmation screens. [Figure 25] FIG. 25 illustrates at least an exemplary embodiment of various history screens. [Figure 26] FIG. 26 illustrates at least an exemplary embodiment of various reporting screens. [Figure 27] FIG. 27 illustrates at least an exemplary embodiment of various diary screens. [Figure 28] FIG. 28 illustrates at least various exemplary embodiments of the Treatment Per Day screen. [Figure 29A] 29A-29B show at least various exemplary embodiments of event summary screens. [Figure 29B] 29A-29B show at least various exemplary embodiments of event summary screens. [Figure 30] FIG. 30 illustrates at least an example embodiment of various alarm summary screens. [Figure 31] FIG. 31 illustrates at least an exemplary embodiment of various journal submission screens. [Figure 32] FIG. 32 illustrates an exemplary embodiment of at least various screens related to PC connectivity. [Figure 33] FIG. 33 shows an exemplary embodiment of at least various screens related to transferring a journal entry to a PC. [Figure 34] 34A-34D show an example embodiment of at least various screens related to transferring a journal entry to a PC. [Figure 35] FIG. 35 illustrates an embodiment of an infusion pump system. [Figure 36] FIG. 36 shows an embodiment of a companion / remote control device. [Figure 37A] 37A-37B show an embodiment of a target screen. [Figure 37B] 37A-37B show an embodiment of a target screen. [Figure 38] FIG. 38 shows an embodiment of an event history screen. [Figure 39A] 39A-39C show embodiments of reporting screens. [Figure 39B] 39A-39C show embodiments of reporting screens. [Figure 39C] 39A-39C show embodiments of reporting screens. [Figure 40] FIG. 40 shows an embodiment of a custom input screen. [Figure 41] FIG. 41 shows an embodiment of an add event screen. [Figure 42] FIG. 42 shows an embodiment of an add medication event screen. [Figure 43] 43A-43C show embodiments of screens for alarm setup. [Figure 44] FIG. 44 shows an embodiment of a preferences screen. [Figure 45] FIG. 45 shows an embodiment of a food bolus screen. [Figure 46] FIG. 46 shows an embodiment of the bolus method stop. [Figure 47] FIG. 47 shows an embodiment of an extended bolus stop screen. [Figure 48] 48A-48B show an embodiment of the base method stop. [Figure 49] 49A-49B show an embodiment of a companion self test. DETAILED DESCRIPTION OF THE INVENTION

[0021] (definition) As used in this description and the appended claims, the following terms have the same meanings as the context requires: Unless otherwise required by paragraph 1, terms and conditions shall have the meanings indicated.

[0022] "Device" includes an infusion pump and / or controller, i.e., a separate medical device. means medical devices, including but not limited to devices for wireless control of medical equipment In some embodiments, the term "device" may be used interchangeably with "pump," "injector," "inserter ..." or "inserter." "Inlet Pump", and / or "Controller", and / or "Companion", and and / or "remote controller device" and / or "remote controller" "assembly" is used interchangeably with "assembly."

[0023] "Companion" means a device for the wireless control of another medical device In an exemplary embodiment, the companion also includes a glucose meter / strip reader. In some embodiments, the companion may be administered at least one continuous glucose monitor. The device may include a receiver for receiving a continuous glucose monitoring signal from the glucose monitoring sensor.

[0024] The "input" of the device is thereby given to the user of the device or other operator / caregiver. The user input may include any mechanism by which the user can control the function of the device. (e.g., switches, push buttons, jog wheels(s)), electrical arrangements ( slider, touch screen), wireless interface for communication with remote controller Interface (e.g., RF, infrared), acoustic interface (e.g., with voice recognition), Computer network interfaces (e.g., USB ports), and other types may include an interface.

[0025] "Button" in the context of inputs such as those referred to below as "bolus buttons" " can be any type of user input that can perform a desired function, and pressing This includes but is not limited to buttons, sliders, switches, touch screens, or jog wheels.

[0026] "Alarm" means any device by which an alert to a user or third party may be generated. The alarm may be an audible alarm (e.g., a speaker, buzzer, or voice generator); Visual alarms (e.g., LED, LCD screen), tactile alarms (e.g., vibration element), line signal (e.g., remote controller or wireless transmission to a caretaker), or other mechanism The alarm may include a redundant mechanism (e.g., two different audible alarms) or Multiple alarms, including complementary mechanisms (e.g., audible, tactile, and wireless alarms) may be generated using the mechanisms simultaneously, in parallel, or sequentially.

[0027] "Fluid" shall mean a substance capable of flowing through a streamline, e.g., a liquid. do.

[0028] A "user" is someone who uses a fluid delivery device, whether as part of a drug treatment or not. a person or animal receiving a fluid from another person or animal, or a device for injecting a fluid into another A caregiver or third party involved in programming or otherwise interacting with the device This includes those who:

[0029] "Cannula" means a disposable device that allows fluid to be injected into a user As used herein, a cannula refers to a typical cannula or needle. You may point.

[0030] "Disposable" refers to a part that is intended to be used for a fixed period of time and then discarded and replaced. Refers to any product, device, part, or other item.

[0031] "Reusable" refers to a part that is intended to have an unlimited period of use.

[0032] "Acoustic capacitance measurement" is described in U.S. Patent Nos. 5,349,852 and 5,641,892. No. 6,299,499, both of which are incorporated herein by reference in their entireties. and other technologies incorporated herein by reference. It is intended to mean a quantitative measurement of the relevant volume used.

[0033] The "Temperature Sensor" measures the temperature and sends the temperature information to the controller or pump processor. The devices described herein include any mechanism for communicating the following: skin temperature , AVS temperature, ambient temperature, internal temperature, and fluid temperature, but The device may include one or more temperature sensors for measuring temperature, etc., without limitation.

[0034] An exemplary application of the embodiments of the devices, methods, and systems described herein is for the treatment of diabetes. for the delivery of insulin to people living with the disease, but other uses include , including the delivery of any fluid. Fluids include painkillers for people in pain, chemicals for cancer patients, etc. Various therapeutic fluids include small infusions, chemical therapies, and enzymes for patients with metabolic disorders. Molecules, natural products, peptides, proteins, nucleic acids, carbohydrates, nanoparticle suspensions, and and associated pharmaceutically acceptable carrier molecules. They may be modified (e.g., peptides or proteins) to improve their stability in devices. Specific embodiments herein describe drug delivery applications. However, embodiments are suitable for lab-on-a-chip applications and high throughput applications such as capillary chromatography. It may also be used for other applications, including liquid dispensing of reagents for analytical measurements on the For purposes of discussion, "therapeutic," "insulin," or "fluid" may be used interchangeably. However, in other embodiments, any fluid may be used, as described above. Therefore, the devices and descriptions contained herein are not limited to therapeutic use. .

[0035] Some embodiments of the fluid delivery device are directed to people living with diabetes and / or their The device is adapted for use by a caregiver. Thus, in these embodiments, the device: The method and system supplement the function of pancreatic islet cells in a person (referred to as a user) living with diabetes. To assist or supplement, to help deliver insulin; adapted for insulin delivery Embodiments provide both basal level fluid delivery as well as bolus level delivery. The aim is to mimic the action of the pancreas by measuring basal levels, bolus levels, and Timing can also be controlled by the user using a wireless handheld user interface. It may be set by a caregiver or directly by using the pump. In addition, the basal and / or bolus levels may be triggered in response to a signal from an output and / or continuous glucose monitor; or One or more of these may be adjusted by the controller in an exemplary embodiment. Thus, in some embodiments, the controller may further include a blood glucose glucose monitoring device that may receive data from the sensor and / or interstitial glucose sensor; In some embodiments, the bolus is administered on the device, i.e., the control Use designated buttons or other input means located on the controller and / or infusion pump. In yet another embodiment, the bolus or basal either on the fluid delivery device / infusion pump and / or on the controller may be programmed or administered through a user interface located .

[0036] The names and types of screens given to the screens, as well as appropriate names given to various features Regarding the various embodiments, these terms may vary.

[0037] The systems and methods described herein may be used to control an infusion pump. For purposes of this description, various embodiments of the user interface and infusion pump may be Sometimes described with reference to insulin pumps, or pumps that deliver insulin However, the user interface may be installed on and / or on any infusion pump. It should be understood that instructions may be located on the infusion pump "screen." Where relevant, this "screen" may also appear on the controller or may appear on the controller instead of the , a screen may appear on the infusion pump.

[0038] Infusion pumps contemplated by this description are suitable for administering therapeutics including, but not limited to, insulin. The pump may pump any fluid, including but not limited to therapeutic fluids. Thus, when the present description describes an exemplary embodiment in relation to insulin, are for illustrative purposes only and the device is not intended to be limited to insulin. No. Other fluids are also contemplated.

[0039] The infusion pump may be any infusion pump, such as those shown in FIGS. 1A-1F and 2A-2D. The pump device may be, but is not limited to, a pump device as described with respect thereto. , also published on October 4, 2007, and now U.S. Patent Application Publication No. US-2007- No. 0228071, filed February 9, 2007, entitled Fluid Del. U.S. Patent Application No. 11 / 704,888, filed on ... No. 99 (E70), published September 20, 2007, and now U.S. Patent Application Publication No. US- No. 2007-0219496, filed February 9, 2007, entitled Pump ing Fluid Delivery Systems and Methods U US Patent Application No. 1 for Sing Force Application Assembly No. 1 / 704,896 (E71), published September 20, 2007, and now U.S. Pat. Publication No. US-2007-0219480, filed February 9, 2007; The name is Patch-Sized Fluid Delivery Systems and d Methods, U.S. Patent Application No. 11 / 704,886 (E72), September 2007 The patent application was published on January 20, 2007, and is currently U.S. Patent Application Publication No. US-2007-0219597. The patent application was filed on February 9, 2007, and is entitled Adhesive and Peripheral eral Systems and Methods for Medical Dev ices' U.S. Patent Application No. 11 / 704,897 (E73), filed December 3, 2009 Published U.S. Patent Application Publication No. US-2009-0299277, 200 The patent was filed on December 31, 2008, and is entitled "Infusion Pump Assembly." U.S. Patent Application No. 12 / 347,985 (G75), published November 12, 2009 The present application is now U.S. Patent Application Publication No. US2009-0281497, and was filed December 2008. A U.S. patent entitled "Wearable Pump Assembly" was filed on the 31st of this month. Patent application No. 12 / 347,982 (G76), published November 5, 2009, is currently U.S. Patent Application Publication No. US-2009-0275896, published December 31, 2008 No. 6,299,299, filed on 2004, entitled Infusion Pump Assembly. No. 12 / 347,981 (G77), issued December 11, 2007, and currently U.S. Pat. No. 7,306,578, filed on January 4, 2002, entitled Loadi U.S. Patent Application No. 10 for ing Mechanism for Infusion Pump / 037,614 (C54), published April 16, 2009, and currently U.S. Patent Application Publication No. US-2009-0099523, filed October 10, 2008 , U.S. Patent Application No. 12 / 249 entitled Infusion Pump Assembly ,891(G46), filed on October 10, 2008, entitled Infusion Pump Assembly, U.S. Patent Application No. 12 / 249,882 (F51), 2 Filed on October 10, 2008, entitled System and Method for r Administering an Infusible Fluid US Patent Issued Application No. 12 / 249,636 (F52), filed October 10, 2008, entitled Occlusion Detection System and Method, USA Patent Application No. 12 / 249,621 (F53), filed October 10, 2008; The name is Multi-Language / Multi-Processor Infusi on Pump Assembly, U.S. Patent Application No. 12 / 249,600 (F54) , filed on October 10, 2008, entitled An Infusion Pump A US patent issued for assembly with a Backup Power Supply Application No. 12 / 249,540 (F55), and filed October 10, 2008, Name: Pump Assembly with a Removable Cover Assembly, U.S. Patent Application No. 12 / 249,496 (F56) all of which are incorporated by reference in their entirety. In an exemplary embodiment, the infusion pump communicates wirelessly with the controller. However, in various embodiments, the infusion pump includes hardware for F communication. 1A to 1F and 2A to 2D. In some exemplary embodiments, the infusion pump includes a display assembly 104. However, in other exemplary embodiments such as those shown in FIGS. 2A-2D In some embodiments, the infusion pump may not include a display assembly. may be similar to or similar to those shown in Figures 1A, 1D, and 1F. The display assembly, which may be larger or smaller, is attached to the controller or Included on a companion device. Shown in 3.

[0040] 1A-1F, an infusion pump 106 may be housed within enclosure assembly 102. 1 shows an embodiment of an infusion pump assembly 100, which includes an enclosure. A display system 104 may be viewable through the assembly 102. One or more switch assemblies / input devices 106, 108, 110 may include , may be installed around various portions of the enclosure assembly 102. 02 is an injection port assembly to which the cannula assembly 114 can be releasably coupled. 112. A removable cover assembly 116 covers a power supply cavity 118 (FIG. This may allow access to the endothelial cells (shown in false images in 1D).

[0041] Referring to the infusion pump assembly shown in FIGS. 1A-1F, the infusion pump assembly 100 may include one or more components that may be required for proper operation of infusion pump assembly 100. The process may include processing logic (not shown) that performs the process of one or more microprocessors (not shown), one or more input / output controllers (not shown), The processing logic may include a processor (not shown), and a cache memory device (not shown). one or more data buses and / or memory buses to interconnect one or more subsystems In some embodiments, one of the subsystems shown in FIG. At least one of these also includes the implementation of infusion pump assembly 200 shown in FIGS. 2A-2D. This is also included in the embodiment.

[0042] The various embodiments of the infusion pump shown in FIGS. 2A-2D are both DEKA Pro Transferred to ducts Limited Partnership, November 1996 Issued on the 19th, the name is Flow Control System with Vo lume-Measuring System Using a Resonatabl e Mass U.S. Patent No. 5,575,310 (B28), and May 26, 1998 Issued on the date, named Cassette for Intravenous-Line Flow-Control System U.S. Patent No. 5,755,683 (B13 ), and U.S. Patent Application Publication No. US-2007-012004, which was published on October 4, 2007, and is now U.S. Patent Application Publication No. US-200 No. 7-0228071, filed February 9, 2007, entitled Fluid D Delivery Systems and Methods, U.S. Patent Application No. 11 / 70 No. 4,899 (E70), published September 20, 2007, and now U.S. Patent Application Publication No. No. US-2007-0219496, filed February 9, 2007, entitled P umping Fluid Delivery Systems and Methods US Patent for Using Force Application Assembly Application No. 11 / 704,896 (E71), published September 20, 2007, now U.S. Publication No. US-2007-0219480, filed February 9, 2007. The new product, called Patch-Sized Fluid Delivery Systems, and Methods, U.S. Patent Application No. 11 / 704,886 (E72), 200 Published on September 20, 2007, and currently U.S. Patent Application Publication No. US-2007-0219597 No. 11 / 2007, filed on February 9, 2007, entitled Adhesive and Per ipheral Systems and Methods for Medical Devices, U.S. Patent Application No. 11 / 704,897 (E73), and 2009 Published on December 3, now U.S. Patent Application Publication No. US-2009-0299277 A patent application filed on December 31, 2008, entitled Infusion Pump As and U.S. Patent Application No. 12 / 347,985 (G75) to Sembly. nothing.

[0043] 2A-2D, infusion pump assembly 200 includes a reusable housing assembly. The reusable housing assembly 204 may include a rigid, compression-resistant It may be constructed from any suitable material, such as a durable or rigid plastic. The use of materials and components with high durability will last longer and improve the By providing reusable parts that provide better protection for components that are reused This can improve quality and reduce costs.

[0044] The reusable housing assembly 204 contains a pump assembly and at least one valve assembly. The reusable housing may include a mechanical control assembly (not shown) having a reusable housing. The body assembly 204 also provides one or more control signals to the mechanical control assembly to control the user. configured to achieve basal and / or bolus delivery of an infusible fluid to the The disposable housing assembly 202 may include an electrical control assembly for controlling the fluid passages. at least one valve assembly that may be configured to control the flow of infusible fluid therethrough; The reusable housing assembly 204 may also contain a fluid supply for the infusible fluid. and a pump assembly that may be configured to pump the device from the body passageway to the user. good.

[0045] The electrical control assembly may be housed within a reusable housing assembly 204; Also, pumped and / or being pumped, injectable flow For example, the electrical control assembly may include a capacitive sensor assembly. receives a signal from the pump, calculates the amount of injectable fluid that has just been dispensed, and Based on the dose required by the If not enough infusible fluid is dispensed, the electrical control assembly The electrical control assembly may determine that an infusible fluid should be pumped. The assembly is attached to a mechanical control assembly so that any additional required dose is pumped. The electrical control assembly may provide an appropriate signal to the bri or to determine whether or not to add the next dose. An appropriate signal may be provided to the mechanical control assembly so that the dose is dispensed. Therefore, if too much injectable fluid is dispensed, the electronic control assembly will Send the appropriate signal to the mechanical control assembly so that less injectable fluid is dispensed at may be provided.

[0046] The mechanical control assembly may include at least one shape memory actuator. The pump assembly and / or valve assembly of the mechanical control assembly may include at least one one shape memory actuator, e.g., a shape memory wire in a wire or spring configuration; The shape memory actuator may be a shape memory actuator. , of the thermal and / or electrical energy used to operate the mechanical control assembly. operatively connected to an electrical control assembly capable of controlling the timing and amount of The shape memory actuator may be, for example, a conductive material whose shape changes with temperature. The temperature of the shape memory actuator can be controlled by using a heater. Or, more conveniently, may be changed by the application of electrical energy. The actuator is a material such as NITINOL® or FLEXINOL®. It may be a shape memory wire constructed of a nickel / titanium alloy.

[0047] Infusion pump assembly 200 may be configured to adjust the amount of fluid infused by the infusion pump assembly. The sensor may include a capacitive sensor assembly configured to monitor the The assembly is described, for example, in the following references, both DEKA Products Ltd. Transferred to the IT Partnership under the name Flow Control S ystem With Volume-Measuring System Using a Resonatable Mass U.S. Patent No. 5,575,310 (B28) , and the name Cassette for Intravenous-Line Flo w-Control System Patent No. 5,755,683 (B13), and Published October 4, 2007, now U.S. Patent Application Publication No. US-2007-0228 No. 071, filed February 9, 2007, entitled Fluid Deliver Systems and Methods, U.S. Patent Application No. 11 / 704,899 (E70), published September 20, 2007, and now U.S. Patent Application Publication No. US-200 No. 7-0219496, filed February 9, 2007, entitled Pumping Fluid Delivery Systems and Methods Usin g Force Application Assembly, U.S. Patent Application No. 11 / 7 No. 04,896 (E71), published September 20, 2007, now U.S. Patent Application Publication No. US-2007-0219480, filed February 9, 2007, entitled Patch-Sized Fluid Delivery Systems and M ethods' U.S. Patent Application No. 11 / 704,886 (E72), and September 2007 The patent application was published on January 20, 2007, and is currently U.S. Patent Application Publication No. US-2007-0219597. The patent application was filed on September 9, 2007, and is entitled Adhesive and Peripheral eral Systems and Methods for Medical Dev ICES, U.S. Patent Application No. 11 / 704,897 (E73), Acoustic capacitance sensing may be employed using acoustic capacitance measurement techniques, including but not limited to: all of which are incorporated herein by reference in their entirety. Other alternative techniques for measuring, e.g., Doppler-based methods, vane or flapper valves the use of Hall effect sensors in combination with strain beams (e.g., the deflection of a flexible member) (relating to a flexible member covering a fluid reservoir to sense only the fluid) and capacitive sensing using a plate The use of ion beam splitting or thermal time-of-flight techniques may also be used. One such alternative technique is It was published on October 4, 2007, and is currently Publication No. US-2007-0228071. A patent application filed on February 9, 2007, entitled Fluid Delivery System ems and Methods, U.S. Patent Application No. 11 / 704,899 (E70) No. 6,239,999, which is incorporated herein by reference in its entirety. The pump assembly 200 is configured such that the volume measurements provided by the volume sensor assembly , to control, through a feedback loop, the amount of infusible fluid injected into the user. It is configured to be usable for

[0048] Infusion pump assembly 200 may further include a disposable housing assembly 202 For example, the disposable housing assembly 202 may be designed for a single use or for a specified period of time. For example, it may be configured to be used for three days or any other period of time. Assembly 202 is any part of infusion pump assembly 200 that comes into contact with the infusible fluid. The components may be mounted on the disposable housing assembly 202 and / or the disposable housing assembly 2 02. For example, the fluid passage or chamber containing the reservoir may be configured to be disposed within the fluid passage or chamber. The nozzle may be placed in a disposable housing assembly 202 and may be designed for single use. or may be configured to be used a specified number of times before being discarded. The disposable nature of the plug 202 may improve hygiene of the infusion pump assembly 200.

[0049] Disposable housing assembly 202 is releasably engaged with reusable housing assembly 204. and may be configured to accommodate an injectable fluid (not shown), e.g., insulin. Such releasable engagement may include, for example, a cavity having a reservoir for receiving a seal. This may be achieved by a threaded, twist lock, or compression fit configuration. The assembly 202 and / or the reusable housing assembly 204 may be a disposable housing assembly. 202 and the reusable housing assembly 204 to engage in a specific orientation. The device may include an alignment assembly configured to facilitate alignment. The bottom tuberosity 206 and top tuberosity 208 may be used as indicators of alignment and full engagement. good.

[0050] 2A-2B, this particular embodiment of infusion pump assembly 200 In an embodiment, the infusion pump assembly 200 is configured to include a circumferential wall 240 extending around the periphery of the infusion pump assembly 200. In other embodiments, for example, the switch assembly 210 shown in FIG. In the embodiment shown in Figures 2C-2D, the switch assembly 216 includes a top surface. The reusable housing assembly 204 may be installed on other surfaces, including but not limited to, the reusable housing assembly 204. Referring back to FIG. 2B, in the exemplary embodiment shown, switch assembly 210 includes: It may be located along a radial edge of the infusion pump assembly 200, which allows the user to The switch assembly 210 may be configured to allow water to flow through the infusion pump assembly. The assembly 200 may be covered with a waterproof membrane configured to prevent water from entering the assembly 200. The available housing assembly 204 includes a main body portion (mechanical and electrical control assembly as described above). The assembly is configured to rotate (in the direction of arrow 214) about the body portion. and a locking ring assembly 212 which may be attached.

[0051] In a similar manner to the reusable housing assembly 204 and the disposable housing assembly 202 , the reusable housing assembly 204 is releasably attached to the disposable housing assembly 202. Such releasable engagement may be, for example, a screw-type, a twist-type, or the like. This may be achieved by a twist lock or compression fit configuration. In the illustrated embodiment, a user of infusion pump assembly 200 first inserts the reusable housing. The body assembly 204 may be properly positioned relative to the disposable housing assembly 202; The reusable housing assembly 204 is then releasably attached to the disposable housing assembly 202. The locking ring assembly 212 may be rotated (in the direction of arrow 214) to engage the to).

[0052] By using the locking ring assembly 212, the reusable housing assembly 2 04 is properly installed relative to the disposable housing assembly 202, and then the locking ring assembly The releasably engageable connector 212 can be releasably engaged by rotating the connector 212, and is therefore reusable. Eliminates the need to rotate the housing assembly 204 relative to the disposable housing assembly 202 Therefore, the reusable housing assembly 204 may be attached to the disposable housing assembly 204 prior to engagement. assembly 202, and such alignment is not disturbed during the engagement process. The locking ring assembly 212 may be reusable with the housing assembly 204 and The locking ring assemblies 202 are then pulled apart until the disposable housing assemblies 202 are properly seated relative to each other. A latch mechanism (not shown) may be included that may prevent the bridge 212 from rotating.

[0053] 1A-1F and 4, the process logic 400 and interconnected Examples of subsystems that may be used include a memory system 402, an input system 404, a display system 406, vibration system 408, acoustic system 410, motor assembly 416, These include a force sensor 412, a temperature sensor (not shown), and a misalignment detection device 418. Infusion pump assembly 100 may include, but is not limited to, power sources within power cavity 118. The power supply 118 is configured to be removable and insertable into the power supply cavity 118, and the processing logic 400 At least a portion and one or more of the subsystems (e.g., memory system 402 , an input system 404, a display system 406, a vibration system 408, an acoustic system The actuator 410, the motor assembly 416, the force sensor 412, and the displacement detection device 41 8), and may include a main power source 420 (e.g., a battery) configured to provide power to the good.

[0054] Infusion pump assembly 100 is configured to contain an infusible fluid 422. In some embodiments, the reservoir assembly 430 may include a reservoir assembly 430. 30, which is incorporated herein by reference in its entirety, March 3, 2009 issued in 2013, and named Optical Displacement Sensor for r Infusion Devices, U.S. Patent No. 7,498,563 (D78) Reservoir assemblies similar to those described, and / or December 11, 2007 , entitled "Loading Mechanism for Infusion" Pump's U.S. Patent No. 7,306,578 (C54), issued October 10, 2008 12, filed for U.S. patent application Ser. No. 12, entitled Infusion Pump Assembly. / 249,882 (F51), and published on May 16, 2009, and now U.S. Pat. Publication No. US-2009-0099523, filed October 10, 2008 12 / 2 entitled Infusion Pump Assembly, 49,891 (G46) and these may be reservoir assemblies. all of which are incorporated herein by reference in their entirety. In the reservoir assembly, the fluid is allowed to flow through the reservoir assembly until at least a portion of the fluid flows out of the reservoir assembly. The reservoir assembly may be any assembly that can be actuated to release the fluid. The bridge, in various embodiments, includes a barrel with a plunger, a cassette, or at least These include, but are not limited to, containers constructed in part from flexible membranes.

[0055] The plunger assembly 424 allows the infusible fluid 422 to be delivered to the user 454. In this manner, the infusible fluid 422 is pumped from the reservoir assembly 430 to the cannula assembly 45. 0 (which may be connected to infusion pump assembly 100 via infusion port assembly 424) In this particular embodiment, the plunger The motor assembly 424 responds to signals received from the process logic 400 by A part that may be engaged with a lead screw assembly 428 that may be rotatable by a spring 416. The minute nut assembly 426 is shown movable by the minute nut assembly 426. In this state, the motor assembly 416, the plunger assembly 424, the partial nut assembly The combination of 426 and lead screw assembly 428 is contained within reservoir assembly 430. A pump assembly may be formed to accomplish the dispensing of the contained infusible fluid 422 . An example of a partial nut assembly 426 includes a lead screw assembly 426 with, for example, a 30 degree wrap. Examples of suitable nut assemblies include, but are not limited to, nut assemblies configured to fit into a In one embodiment, the pump assembly is a pump assembly according to the invention, issued on December 11, 2007, entitled "L Patent for Loading Mechanism for Infusion Pump No. 7,306,578 (C54), filed on October 10, 2008, entitled Inf Fusion Pump Assembly, U.S. Patent Application No. 12 / 249,882 (F 51), and published April 16, 2009, now U.S. Patent Application Publication No. US-20 No. 09-0099523, filed on October 10, 2008, entitled Infu U.S. Patent Application No. 12 / 249,891 (G4 6), all of which are incorporated herein by reference. is incorporated herein in its entirety.

[0056] (User Interface) Throughout this description, screens may be referred to as "Pump" or "Companion" or "Controller" However, in various embodiments, reference may be made to another device. A similar screen or method may be achieved above. For example, the screen or method may be When reference is made to a "pump," a similarly functional screen or method may be used in other embodiments. This description applies to pumps with displays. The embodiments include embodiments for both pumps with and without displays. If your device includes an infusion pump without a display, you must display any screens in at least one companion Similarly, the method can be seen to When interaction is requested, if the pump is an infusion pump without a display, the interaction is This may be accomplished via a switch assembly on the board.

[0057] In some embodiments, a user or caregiver may Process logic, including at least one element, is used to receive input from a person The user or caregiver may operate the following: button / switch assembly, slider (e.g., No. 6,248,793, published July 24, 2008, which is incorporated herein by reference in its entirety. Published in January 2007, now U.S. Patent Application Publication No. US-2008-0177900. The application, filed on February 4th, is entitled Medical Device Including a Slider Assembly, U.S. Patent Application No. 11 / 999,268 any slider, including but not limited to, a jog wheel, or touch one or more input devices, including but not limited to one or more screens, The infusion device further includes an occlusion detection process 438, a confirmation process 440, including but not limited to capacitance measurement techniques (e.g., acoustic capacitance sensing), Using these inputs, the infusion device receives inputs from the user's system, e.g. including delivery of injection fluid to the user, or any comment, alert, alarm, or warning to the user. The inputs are, therefore, direct from the user to the pump. to the pump, directly from the pump system to the process logic, or to another device, e.g. Either from a controller device (described in more detail below) to the pump. Thus, the user or caregiver's interaction experience includes the following: Display, including but not limited to reading / seeing text and / or graphics (either on the infusion pump device itself or on the remote controller device, or Direct interaction with the display, e.g., via a touch screen; buttons, sliders, jog wheels, interaction with one or more glucose strip readers, etc. and either tactile or acoustic, one or more vibration motors, and / or an acoustic system. These include, but are not limited to, one or more of the following: The term "interface" refers to the interface through which a user or caregiver interacts with an infusion pump. Any system used to control an infusion pump and / or make treatment decisions The term "system" is used to encompass systems and methods.

[0058] Referring now to FIG. 3, in some embodiments of the infusion pump system, the infusion pump The controller is a remote controller assembly, also known as a controller or companion. 00. Remote control assembly 300 is shown in FIGS. 1A-1F. 1. It may include all or part of the functionality of the infusion pump assembly itself shown in Therefore, in some exemplary embodiments of the infusion pump assembly described above, the infusion The pump assembly (not shown, see Figures 1A-1F, among other figures) is remotely controlled. In these specific embodiments, the injection pump may be configured via assembly 300. The infusion pump assembly may be configured to communicate between the infusion pump assembly and, for example, the remote control assembly 300. communication (e.g., wired or wireless) so that remote control assembly 300 Telemetry circuitry (not shown) that allows the inlet pump assembly 100 to be remotely controlled. ) may include a remote control assembly 300 (which may also include telemetry circuitry (not shown) and may be capable of communicating with the infusion pump assembly. The play assembly 302 and the following input control devices (jog wheel 306, slide 310, or another conventional mode for input to the device, etc.), switch an input assembly, which may include one or more of the assemblies 304, 308; Therefore, the remote control assembly 300 shown in FIG. 06 and slider assembly 310, although some embodiments may include a jog wheel. 306 or slider assembly 310, or another conventional means for input to the device. The embodiment with jog wheel 306 may include only one of the modes. In some embodiments, the jog wheel 306 may include a wheel, ring, knob, or the like. , providing a control signal based, at least in part, on the movement of a wheel, ring, knob, etc. For example, the sensor may be coupled to a rotary encoder or other rotary transducer for measuring the rotational speed of the sensor. In some embodiments, the user may, as a preference, input a counter to one or more of the input devices. Start-up and / or countdown speed, and input commands for speed changes For example, a switch device may specify / indicate a count up / count down command. It must be held down for 3 seconds before the speed changes to 4 seconds. In various embodiments, each input device may include a separate input for user preferences. , and / or in some embodiments, the user indicates preferences and selects all of the same preferences. In some embodiments, the count up / count down input device may be applied to The downspeed is pre-programmed until and unless the user changes the speed. The speed may be programmed.

[0059] The remote control assembly 300 allows pre-programming of basal rates, bolus alarms, and delivery limits. It may also include the ability for users to view history and establish user preferences. The remote control assembly 300 may also enable the glucose strip reader 312.

[0060] In use, the remote control assembly 300 is connected to the infusion pump assembly 300. providing instructions to the infusion pump assembly via a wireless communication channel established between the Therefore, the user may use the The remote control assembly 300 may be used in conjunction with an infusion pump. Some or all of the communication between the assembly and the As mentioned above, in some embodiments, the remote control assembly The device 300 also receives signals from at least one continuous glucose monitor.

[0061] In an exemplary embodiment of the user interface, the user interface may include a user confirmation An exemplary embodiment of the user interface allows the user to The emphasis is on ensuring that the effects of various interactions on the pump are known. Many embodiments are presented that communicate the results of a user's actions to the user. ensures that users understand what they are doing and therefore provides greater security to users. One such example is when the user clicks the back button on the screen after the value has been changed. In an exemplary embodiment of the user interface, the user interface The change cancellation confirmation screen shown in Figure 6 is displayed. If the user selects "Yes," The user interface discards any pending changes, closes the confirmation screen, and returns to the previous screen (all (i.e., the screen before the one where the user pressed the back button) If the action selection on the "Yes?" confirmation screen is "No," the user may, depending on the embodiment, Press the button or other button, the user interface will close the confirmation screen and This feature allows the user to think that the change has been made, but in fact it has not. This feature therefore prevents the conclusion that they have not been implemented. This prevents situations like this and ensures that users understand that no changes have been made.

[0062] (Power on) In general, infusion pumps, with a few exceptions, are used by users to administer therapy almost continuously. Therefore, when the infusion pump is "powered on," i.e., the battery is inserted into the pump and the pump is "set up" for use in therapy, Infusion pumps remain powered on and often provide a cannula to the user. Often, users will remain connected for a short and predictable period of time. , "disconnecting" or severing the fluid connection of the tubing to the cannula. The user should remove the reservoir while changing the cannula and while changing the infusion set. During changes, while preparing the tube, while bathing / showering, during MRI or other examinations, While receiving or otherwise being exposed to harmful forces, such as electromagnetic forces, may occur during exercise or exposure to potentially corrosive water, e.g., salt water. There are many additional situations in which a user may disconnect. However, generally these disconnection events are planned and the user is not required to disconnect from the pump. I understand that I will not receive treatment from the infusion pump while I am in the

[0063] Thus, once infusion pump therapy is initiated with a given pump, the user The infusion pump may be used in conjunction with another form of treatment, such as another pump or multiple injections per day. It will remain connected and will not affect the infusion pump until and unless it is replaced. Users are more likely to receive treatment from

[0064] The power-on user interface is visible when the battery is inserted into the infusion pump. If the infusion pump was used by the user before the battery was replaced, , the pump is initialized. If the pump has not been used previously by the user (i.e. If the pump is new to you, the first time you use the pump, the user interface The interface must be initialized before insulin delivery or other fluid therapy delivery can occur. It automatically guides the user through programmable settings that should not be configured.

[0065] Now, referring to FIG. 5A, after an initialization period, the user interface prompts the user to Time and Date Wizard that guides you to the Time / Date screen, Set Time screen, and Set Date screen and then to the Home screen (also described with respect to Figures 10A-10E). If a valid time is detected, the user's default selection is Time / The user interface is "Next" on the date screen 500, and the user interface is Then proceed to the home screen 504.

[0066] However, referring now to FIGS. 5B-5C, the system is enabled at certain times and dates. If the wizard does not detect a timestamp, the time value is set as if no current value had been set. The time / date screen should be displayed with a dotted line (--) indicating that the date is not set. Bids will not be displayed until a valid time is set.

[0067] Among other benefits, time and date are stored when the system detects a valid time / date. The wizard will automatically fill in the time / date with the valid time / date it finds. However, the system still ensures that the user can review the detected time / date and Presents the user with an opportunity to change the time / date if it is incorrect. In the exemplary embodiment shown, the system continues to play the video until the user selects "Next," i.e., Do not complete initialization and proceed to the home screen until you determine the time / date is acceptable.

[0068] Conversely, if an invalid date is detected, the system will not automatically fill in the time / date, but rather Therefore, the user interface system requires the user to fill in the In an exemplary embodiment, the user is prompted to always review the time / date.

[0069] Some embodiments of the user interface include a practice mode. Generally, it is used when the user or caregiver first uses the pump and is therefore not recommended for review. Additional time may be required to complete the exercise and enter information into the user interface. The mode allows the user to select a period for which the user interface will override the timeout. In normal mode, the user interface is Countermeasures include timeouts, where the screen times out after a pre-defined period of user inactivity. However, in this embodiment, the timeout is disabled. In this state, when practice mode is initialized, the "duration" is set by the user or caregiver, e.g. For example, it may be set to 2 hours, during which time the timeout is disabled.

[0070] (user setup) User setup is a set of settings for the user and pump used for therapy. It includes many features, including companion pairing, time, date, and time / date display format. Formula, time display format, glucose units (mg / dL vs. mmol / L), language, blood glucose target for time , time of day basal rate, or pre-programmed name, insulin type, insulin action duration, cursor preference, magnification preference, bolus button, bolus and basal limits, "1 (U drip) (1 unit drip), next to display / buttons, carbohydrate to insulin ratio, options Alarm characteristics, including alarm type if present, sensitivity to occlusion, and inactivity Including setting alarms, treatment lockouts, care comments, and reminders Not limited to these.

[0071] As described above, in an exemplary embodiment, the infusion pump system may include, for example, In these embodiments, the controller or companion device may be similar to the one shown. is powered on if the pump is not currently paired and is not fully initialized. The user first connects the pump to a remote control device, i.e., a controller, as described above. For example, if the user is prompted to pair with a companion, If the user does not wish to pair with a device, the user can choose to omit this option. In this case, the user interface will redirect the user to another setup screen. Go ahead.

[0072] Referring to FIG. 7A, the user selects to begin pairing (by selecting OK). If the pump is connected to a companion device, the user interface will display the companion searching screen for the pump. (In embodiments where the pump does not include a display, the companion Please note that this is the only screen on the companion. (Appears only in the game.) A remote companion must be in pairing mode to complete the pairing. Therefore, to pair an infusion pump with a companion, both devices must be This feature is one of many safety features during the pairing process. By requiring both devices to be in paired mode, This ensures that the infusion pump cannot be "hijacked" by an unintended companion. If the pairing fails or is cancelled, the user will be notified of the pairing failure or cancellation. When you select OK on the warning screen, the user interface returns to the Setup Wizard. Go to Step 1 on the screen and set the wireless setting to "Off". If the system is not paired, the pump user interface will automatically turn off the radio and Proceed to continue with the setup wizard.

[0073] Referring now to FIG. 7B, a pump and a companion device for remote communication may be connected. To pair, the pairing process requires user interaction on both the pump and the companion. In an exemplary embodiment, the user interface may prompt the user to "set up" When you select and accept the "Device Pairing" item on the screen, the pump "Pairing" icon will appear on the pump. The user will see the "Searching for Device" screen. The user will then click the "Pair Device" icon to begin the pairing process. Select the item to start searching for remote control companion devices in paired mode. On the "Setup" screen, the user selects "Pump Pairing" and then "Pump Pairing." On the confirmation screen, select "Yes" to select the action. Before selecting, the user must start the pump survey. To initiate pairing mode, both the infusion pump and companion must simultaneously must be in the unified mode.

[0074] The user selects the "Device Pairing" item on the pump "Setup" screen and When you press the power button, the user interface displays: 1) if the radio is off; 1) Turn on the radio and 2) connect the companion device in pairing mode (pairing starts on the companion 3) Starts a search for the companion you are searching for, and 3) displays the "Searching for Companion" screen.

[0075] Now, referring to FIG. 7C, the user interface is now in companion mode. When a companion is found, the pump will display a "Searching for Companion" screen followed by a "Discovery" message on the pump. Display the "Discovered Companion {Companion Serial Number #}" screen. The companion's serial number will be displayed in place of "Companion Serial Number #}". This screen indicates that a companion in pairing mode has been discovered, but pairing has not yet been completed. The user must confirm pairing on the companion device to complete the pairing process. This feature ensures that the discovered pump is indeed the one the user is using. Ensure you have the opportunity to verify that the pump is the one intended to be paired with the device Do so.

[0076] The user interface allows the user to initiate pairing and search for a companion in pairing mode. but failed after about a minute of searching, and the message "Companion not found" appeared on the pump. In other embodiments, the amount of time to search may vary. After searching for a companion for a defined period without any interruptions, a companion is found. If not, the pump user interface, in an exemplary embodiment, turns off the radio. and warns the user (see Figure 7D). This is If the initialization mode is initiated but not on the pump, a timeout period is Ensure that the mode is exited.

[0077] Referring to FIG. 7E, the user interface may be paired on the companion device. When the pump is recognized, the message "Pump paired with {Companion Serial Number #}" will be displayed on the pump. In an exemplary embodiment, the user interface displays a screen. The companion device serial number that the pump is paired to when the pump is successfully paired This feature displays an indication to the user of the intended companion. The user is given the opportunity to verify that the serial number is paired with the pump.

[0078] Once "Done" is selected, the pump will be fully initialized and the pump will return to the Home screen. If the pump is not fully initialized, the user interface Step 1 of the Setup Wizard will be displayed.

[0079] Although the above embodiment is described with reference to a pump screen, similar This screen will appear on your companion.

[0080] During pairing, the user interface will prompt the user to enter the pump "Companion Searching" screen. When you press a button on your pump while viewing the companion "Searching for Pump" screen When you press the button on the companion while viewing the screen, the pump or companion device Displays a "Pairing Cancelled" warning screen on either the pump or The companions have been paired before attempting to pair them again, and the user has When undoing a transformation, the existing transformation is lost.

[0081] If the user presses the Search button on the pump or companion while the "Searching for..." screen is displayed If the user presses the button, the pairing may be cancelled. The interface requires that the pairing process be completed before the pump and companion can be successfully paired. The user is then informed that the pump and It is understood that the anions may be unpaired (in the exemplary embodiment, the pump and (When a pet and companion are paired, a screen or audio signal will indicate this.)

[0082] In an exemplary embodiment, the user interface is displayed on the companion during the pairing process. Shows glucose units different from the set units (i.e., mg / dL vs. mmol / L) When a paired mode pump with the same serial number is found, the "Compatible" message appears on the companion. A warning screen will appear saying "An unsupported pump has been found. Pairing has failed." As a feature, the user interface allows the pump and companion to If the user has different glucose units, pairing of the two devices is not allowed. When attempting to pair a pump and companion with It can be done.

[0083] Either after pairing is complete, or once pairing has been omitted, the user can Complete the Setup Wizard to configure various aspects of the user interface.

[0084] As described above with respect to FIGS. 5B-5C, the infusion pump may deliver insulin (or another fluid) to the patient. For time-based delivery of the substance (as in the exemplary embodiment, however, In other embodiments, the pump may be configured to pump on another basis, such as "every 2 hours" or "once a day." It is important that the time setting is accurate. In some embodiments, the pump device records the history of insulin (or other fluid) delivery. Therefore, it is important that the date is set correctly. When the system detects a valid time, or if the system does not detect a valid time, the current time setting is reset to the default value. Instead, the user interface prompts the user to set the current time. Additionally, when the user replaces the battery in the pump, the user interface Ask users to review their current time settings to ensure the time is accurate. demands.

[0085] After the user sets a valid time, the time is recorded by the device's real-time clock. After the device is fully initialized, the user can view the setup screen. Enter through either the Setup Wizard or the Time and Date Wizard The current time may be changed by

[0086] If the user changes the time and / or date on the pump and then When accessing the user interface on the companion, the time and date The time and date on the Companion will be synchronized with the pump time and date, and the time on the Companion will change to the pump time. A warning screen will appear on the companion indicating that

[0087] When you first initialize your pump or if the system does not detect a valid date The current date setting does not have a default value and the user interface displays the current date. In addition, when the user replaces the battery in the pump, The user interface ensures that the current date setting is accurate. prompts the user to review the current date setting.

[0088] After the user sets a valid date value, the date is updated by the pump's real-time clock. If the user enters an invalid date, the pump will After the device is fully initialized, it will display the same audible and / or visual indications as when it is not , the user can go through the setup screen, setup wizard or time and date You may change the current date by entering any of the wizards.

[0089] The user interface includes a pre-programmed list of "valid dates." These may be based on the Gregorian calendar, or any other pre-definable pattern. These may include, for example, the number of days in a particular month, the date February 29th, In an exemplary embodiment, the year includes, but is not limited to, a year in which the date is a valid date. The user interface allows these parameters to be set only at the system level, i.e. However, other embodiments may allow the In this case, the user interface may allow the user to change the parameters. stomach.

[0090] In an exemplary embodiment of the pump, the pump is an insulin pump, as described above. The insulin concentration value (units / mL) is pre-programmed to "U100" and can be changed by the user. In general, users on insulin therapy should use U100 insulin. This is a safety measure, however, as different insulin treatments are contemplated. In various embodiments, either when a different fluid is injected, this feature: User input may be required to specify the concentration of the fluid.

[0091] The relevant settings that the user may specify are insulin type and operating time. The face uses these to determine the amount of insulin being loaded or "IOB." IOB is a gauge of the insulin "action" currently in the user's The gauge is a quantitative indicator of the effect that can be obtained. Therefore, the amount of bolus used in the bolus calculations, as described later, is compared to the amount of bolus used in the calculations. This information is needed because the operating time and insulin type are used to calculate the IOB. The input is crucial.

[0092] When the pump is fully initialized, the user can configure the pump settings through the setup screen. Select insulin by entering it into the wizard or on the setup screen 8A, these screens allow you to change your insulin settings. An exemplary embodiment is shown.

[0093] Now, referring to FIG. 8B, the user interface allows the user to enter an insulin profile. When you accept the type item on the file edit item selection screen and magnification is set to ON, Opens the Type Settings Edit Item screen. "Zoom" allows the user to zoom in on the cursor and various screens. User input, where users may prefer to enlarge the text to see it better. refers to an option in an exemplary embodiment of the interface. The disclosure of which is incorporated herein by reference in its entirety, is hereby incorporated by reference in its entirety. l Device Including a Slider Assembly pending This includes those described in U.S. Patent Application Publication No. US-2008-0177900. Various embodiments of the features may be used within the user interface.

[0094] When Magnification is "Off" or the user accesses the screen on a companion device When the user interface opens a type item for editing, the type value is used Identify the type of insulin. In an exemplary embodiment, there are two options: fast or short-term. In various other embodiments, additional options are pre-programmed. It may be a programmable and selectable option.

[0095] An exemplary embodiment of the user interface includes a variety of screens for insulin profile screens. Includes various safety features, such as the ability to select the Type item on the Insulin Profile screen to edit. The program is opened and the user presses a softkey button to select the "Next" or "Done" action. When the user clicks the button, the user interface either: 1) accepts the selected value and closes, or If you change the type value, the user interface changes the operating time value to a dotted line and displays the The warning message "Item must be configured" is displayed in language-dependent text. This indicates to the user that an action value must be entered. or 3) if the user does not change the type value and selects the action selection, Save the changes and proceed to the next screen.

[0096] 9A-9B, in an exemplary embodiment of a user interface, a user The Enter and Back buttons are used to change the display settings of the pump, e.g., LCD A user interface that is oriented to be on either the right or left side of the display In addition, the device may be configured to have a display screen. When you stop interacting with your device, it turns off the display and goes into a low-power hibernation state. So to save energy, we use screen timeout. Set the screen timeout value as part of the display settings. Screen timeout is the time that your pump It is not enforced until it is fully initialized.

[0097] Another display setting that the user can configure is to display an activity-based home screen or Alternatively, a home screen based on the information is displayed. The home screen is shown in FIGS. 10A to 10E. In an exemplary embodiment, the user interface is The user proceeds through the setup wizard steps by advancing through the display screens. Allows access to pump display settings through two screens. Display settings also apply to ON, select Reference on the Setup screen. It is accessible on the companion by

[0098] Referring to FIG. 9A, the user interface allows the user to time out the display. In addition, the user can use the display screen to set the duration value of the event feature. may be used to select the home screen feature.

[0099] Now, referring to FIG. 9B, the user interface allows the user to The display orientation of the user interface screen can be adjusted by pressing the button (i.e., see Figure 1A). and a feature that allows the switch assembly 108) to be set in relation to the position of the switch assembly 108. For example, the user interface may allow the user to place buttons to the left of the display. In an exemplary embodiment, the user interface allows the user to specify whether the The interface can be configured to, for example, place the button on the right or the default button on the left. It may have settings.

[0100] Now, referring to FIG. 9A, the user interface allows the user to edit the display. User programmable settings for accepting and expanding button items on the collection item selection screen When is set to "ON", open the button setting edit item screen. When Enlarge is set to "OFF", When the device is connected to a companion device, or when the user accesses a screen on the companion device, an exemplary implementation In this form, the user interface opens the button item for editing. The user interface can be configured so that the controls are located either to the right or left of the LCD display. Set the device to orient the screen, accept the button item. Button Screen An exemplary embodiment of is shown in FIG. 9B.

[0101] The user's ability to set the side of the button allows the user to customize the pump for their dominant hand. This allows the user to customize the In addition, the slider 106 may be used as an input device. In some embodiments of the infusion pump shown in FIGS. 1A-1F, a user may The ability to configure the user interface to allow for free use of the dominant hand in This allows the user to input the pump more efficiently and safely. possible.

[0102] In an exemplary embodiment, the user interface includes a bolus calculator. While using the Bolus Calculator option, you must enter specific information about your treatment. However, in some cases, the user may You may choose to enter this information upfront through the setup screen. The information entered may then be used in any calculator that requests this information. However, the information may also be entered at the time of use of the calculator.

[0103] The information used by the calculator is typically based on the recommendations of the user's medical team. The insulin calculator will prompt for this information. In addition to the insulin screen described above, the user may also Additionally, information regarding "1U drip," carbohydrate ratio, and glycemic target may be entered.

[0104] 11A-11B, various 1U drop images are shown, according to an exemplary embodiment. In an exemplary embodiment, the user can select 1-24 1U drops based on time of day. Additionally, the user may set a time-of-day based insulin to carbohydrate ratio of 1 to 24. However, various other embodiments may be used. In this case, the user must set a 1U drop value (and / or I:CHO value) greater than 24. It may also specify a date or a day of the week, among many additional factors that may be specified. The 1U drip value is calculated based on the user's known insulin sensitivity (i.e., how much insulin The I:CHO value is the amount of carbohydrate in grams per day for a specified period of time. Defines the default ratio of insulin to 1 unit. 1U drip value is used to determine the user's blood glucose level. How much insulin the pump can recommend the user deliver to achieve the desired level The 1U drop value may be programmed in hours. In some cases, the 1U drip value may not have been previously set by the user. In this case, while using the Bolus Calculator option, the user can program a correction bolus. When programming, you may specify a 1U drop value.

[0105] In an exemplary embodiment, and as can be seen in FIGS. 11A-11B, the user interface The interface allows the user to administer one unit of insulin to the user's blood glucose level based on the time of day. Program a correction factor value from 1 to 24 that estimates how much change in levels will be brought about. It may be possible to

[0106] If the user enters the amount of carbohydrates and the bolus calculator suggests an insulin dose, The I:CHO value may be used in the curve calculation. In addition, the I:CHO value may be used in the correction and dietary May be used in bolus calculations.

[0107] In an exemplary embodiment of the user interface, the user interface may , when delivering either a normal bolus or an extended bolus, the user interface Through the Bolus screen, define the increment of insulin units used per click of the slider Additionally, in an exemplary embodiment, the user interface allows the user to When the user is setting or editing the speed value of the basic program, the It allows defining the increment of insulin units to be used. In addition to the rider, the increment can be, for example, each button press or each step of a jog wheel. It may be used to define the increment of insulin units used in the pump transfer. However, the incremental functionality may, in various embodiments, be implemented on any desired input device or assembly. It may be used to apply.

[0108] Incremental items allow the user to customize the user interface for the user's general treatment needs. For example, the user interface allows the user to customize For example, you can select increments of "0.10U", "0.05U", or "1.00U". Therefore, a typical bolus or basal dose of 0.30 U may be used. A user with a treatment containing gram amounts may select "0.10U" increments, while a typical Users with treatments that typically include a 10.0U bolus or basal program amount: "1.00U" increments may be selected. This allows the user to Delivery allows for effective use.

[0109] The user interface provides options for setting temporary settings, i.e., temporary basis. In an exemplary embodiment, the temporary settings option allows the user to select a delivery rate. (i.e., units / hour) or in terms of percentage of the base program speed in use. The device may include an option to set or configure a timed basal rate. The user may define a temporary basal rate or a temporary basal rate based on the current basal program. A temporary base reduction may be requested.

[0110] Referring now to FIG. 12, the user interface further comprises, in an exemplary embodiment: ,Users can fix certain features of their devices to ,restrict access to these features. These features include: This may include, but is not limited to, the following:

[0111] 1) A user launches an existing base program and starts it on a temporary basis, Basic menu features that allow you to edit, delete, or rename a program.

[0112] 2) Allows the user to deliver a normal, extended, or dual bolus with one button Enables the bolus feature.

[0113] 3) A pre-priming feature that allows the user to pre-prime the pump.

[0114] Thus, in an exemplary embodiment, the user interface may allow the user to configure the entire pump. Lock out features separately rather than locking or unlocking the entire pump. This feature allows flexibility by allowing child users to or may be unable to make treatment decisions, but may be able to provide advance preparation or This may be advantageous for other users who need access to the basis changes.

[0115] In an exemplary embodiment, the user interface displays when various screens are exited and It contains various features that inform the user when information is missing. For example, see now FIG. 13A. In an exemplary embodiment, when initializing device settings, the user proceeds to the next screen. Previously, any default settings that do not have an initial value, i.e., those represented by dotted lines in the exemplary embodiment, The user interface must also set the value of the setting shown. If you fail to complete these settings, a warning screen will appear saying "Dotted items must be configured." Specifically, in the exemplary embodiment, this warning screen is displayed in the following cases: appear.

[0116] 1) The user initializes the device settings through the setup wizard and then returns When you press the button to return to the Step 1 screen.

[0117] 2) When the user programs a temporary basal or bolus, either The item is set to dotted when the user confirms the "Launch" or "Deliver" action selection. .

[0118] 3) The user initializes the device settings in the following setup wizard. When the user approves the action selection, "Next," "Approve," or "Done."

[0119] - Time / Date screen when either the time or date has not been set.

[0120] - Current time screen when all fields for time values are not set.

[0121] - Current date screen when all fields of date value are not set.

[0122] - Insulin profile screen when no value is set for the Time item.

[0123] - Carb Ratio Block n screen when one or more items have no value set.

[0124] - 1U dripping block n screen when one or more items have no value set.

[0125] - BG target block n screen when one or more items value is not set.

[0126] - Basic program block per day when one or more items have no value set Lock n screen.

[0127] Referring now to FIG. 13B, while the device is in delivery mode, the user interface In an exemplary embodiment, this prevents the user from changing certain settings. When the user selects and accepts a basal limit or wizard item on the setup screen, If the foundation is currently running, the user interface displays a warning: "This feature In addition, if a basic delivery is in progress, the user When the user selects a time or date value on the Time / Date screen, the user interface , display this warning. This is a safety feature in an exemplary embodiment of the user interface. For example, changing the rate of the basal profile while delivering the basal profile. or user changes or edits, such as time / date changes during delivery, that cause disruption during delivery If so, the user interface may use the warning screen shown in FIG. 13B. In an exemplary embodiment, the additional features may not be altered during delivery. This includes, but is not limited to, out-of-band features.

[0128] Referring now to FIG. 14A, in an embodiment where a pump and companion are paired: There are various modifications that can be made to the Companion that may not be accepted by the pump. For example, if the user sets the time and date through a companion-specific time / date screen, When the companion is paired with a pump and the pump is delivering basal, In this embodiment, the pump does not accept the new time and the companion displays the warning "Pump is "Unable to save time and date on the pump." When the companion is on, the pump time is sent to the companion over background synchronization. The Companion will display the warning "Companion time changed to pump time." This warning screen informs the user that the changes they requested have not been made and that the changes It may be used in many different similar scenarios to signal both when a change has been made and when a change has been made. Thus, the user is informed of the consequences of their actions and is therefore advised of the consequences of their actions on the pump. Regularly acknowledge the impact.

[0129] Referring now to FIG. 14B, in an exemplary embodiment, the user interface When the user exits the Companion Preferences screen and the pump is in use or Displays a warning on the Companion when communication with the pump is either interrupted or Therefore, the user acknowledges that their preferences are not stored on the pump. Therefore, the user must re-enter these preferences when communication is restored. Know that it won't happen.

[0130] Referring now to FIG. 15, in an exemplary embodiment, the companion may provide certain functionality, e.g. For example, it allows for a temporary lockout from functions that affect the start and stop of delivery on the pump. However, additional functionality may also be provided in some embodiments. The Therapy Lockout Settings screen shown in Figure 15 , the user can turn on the lockout and specify the period for which the lockout is enforced. If the user selects the "Once" period, the lockout This will remain in effect until the user selects to disable it on the Therapy Lockout Disable screen.

[0131] Now, referring to FIG. 16, the user interface allows the user to Allows you to turn off the radio when paired with a Nion. Change settings on the pump Turns off the radio only on the pump, and similarly, changing settings on the companion This feature can be used in the case of wireless communication, if desired, e.g. , when wireless communication between devices is undesirable, unauthorised or unsafe. Allows the user to turn off the radio.

[0132] (Home screen) 10A-10E, in an exemplary embodiment, a user interface The user accepts the home item on the display's edit item selection screen and expands it. When the user programmable settings are set to ON, the Home Settings Edit item screen When magnification is "off" or the user activates the screen on the companion device, When accessing a home item, the user interface opens the home item for editing. Home screen content can be either information-based or activity-based Approve the home item to designate it as a

[0133] The home screen displays information about device features and pump and delivery status. The home screen provides access to information about the activity-based menu (i.e., to display the current delivery status and last board information. It may be configured to display a home screen based on the user's personal information (i.e., a home screen based on the user's personal information). The home screen is configured through the preferences option on the setup screen.

[0134] Still referring to FIGS. 10A-10E, in an exemplary embodiment, information-based In both the Home screen and the Activity-based Home screen, the user interface Current time, battery level, and inventory information maintained by the device's real-time clock Icons that provide an indication of the volume (or reservoir volume) of the IOB, as well as the volume of the IOB. In some cases, a greater than or equal to sign may appear next to the IOB label. Specifically, if the bolus record contains a damaged record, or if the time is lost and the power is turned on, If the power is turned off, the bolus recording will be reinitialized. When a valid time and date is present at power-on, simply replacing the battery will Therefore, the IOB is not lost when the battery is replaced, In an exemplary embodiment, on the activity-based home screen, each instance of the pump display This feature, in an exemplary embodiment, allows the user to specify the amount of IOBs. This information is provided clearly and efficiently so that the patient can use it to treat the patient. Because the IOB is not lost when replaced, the user has continuous control over their treatment. , relying on the bolus calculator and other instructions on the user interface display However, in some embodiments, the IOB may, in certain circumstances, For example, when the pump determines that it has lost power for more than a threshold time, or when the pump If it is not possible to determine the date and time or the amount of time the pump did not have power Therefore, in these situations, the correct or true value of the IOB However, in exemplary embodiments of the infusion pump, the safety program may not be able to determine The processor maintains the date and time on the device. Therefore, due to the internal clock, IOB recovery is possible.

[0135] Additionally, in an exemplary embodiment, the IOB may also be restored after a reservoir replacement. .

[0136] Still referring to FIGS. 10A-10E, in an exemplary embodiment, the enlarged setting on the pump When the setting is "Off", the cursor type on the home screen based on the information will be related to the cursor setting. This is to keep screen selections distinct. do.

[0137] In an exemplary embodiment, when delivering an extended bolus, the bolus on the home screen based on the information The section shows the amount delivered, the total amount programmed, and the start of the extended bolus. View details of the extended bolus you are taking, including how much time has passed. If the extended bolus is stopped before any of the bolus insulin is delivered, the Home The last bolus information on the screen will now reflect the previous bolus that delivered more than 0.0U. However, if the user powers the pump off and on (i.e. That is, the power supply is removed and replaced, which occurs when the user is replacing the battery. This can occur if the first power source is removed and replaced with a second power source, or (or remove the first power supply and replace it and put it back into the pump), any insulin delivered In an exemplary embodiment, the extended bolus that was stopped before it was reached is the final bolus in the history. The final bolus details on the home screen will reflect that extended bolus.

[0138] Additionally, in an exemplary embodiment, the user interface may include a home screen based on the information. displays the last bolus details, including:

[0139] 1) If the bolus was administered after the most recent power cycle, the last If there is a non-zero bolus in the history other than the zero extension bolus, If not, the user interface displays "None."

[0140] 2) If the power was turned off and on more recently than the last bolus, Also the most recent bolus is displayed; this may be an extended bolus of 0.0U.

[0141] 3) If there is no bolus in the history, the user interface will display "None" do.

[0142] Thus, in an exemplary embodiment, the user interface may include a home screen based on the information. Starting and stopping basal delivery on the surface, starting temporary basal, and switching basal programs In addition, the information-driven home screen provides quick access to The interface provides quick access to bolus features (when in delivery mode) Also, the user interface display will be , a greater than or equal to symbol may be displayed to the right of the IOB label on the home screen.

[0143] 1) Bolus dates for the entire operating period are not available.

[0144] 2) More than a predefined number, e.g., 10, of boluses were given within the operating time.

[0145] 3) If no bolus history exists and the bolus record is initialized, the user will Less time than specified by the available operating time has elapsed.

[0146] 4) The IOB amount is greater than a predetermined number, for example, 300.

[0147] Thus, in an exemplary embodiment, the user interface is It provides information about IOBs within a certain threshold. Access to information that is reliable, accurate, and safe for users to base their treatment decisions on The user only has access to the

[0148] (Alarm and recoverable alarm notification) For the purposes of the present description, and in the exemplary embodiment described herein, notifications are Alarms include alarms, alerts, and reminders. Alarms can be either recoverable or non-recoverable. Warnings, reminders, and recoverable alarms may require user attention. Alerts notify the user of conditions that may affect the normal operation of the pump. Generally, there is a period of time to address the condition, while recoverable alarms will stop delivery. , must be dealt with as soon as possible.

[0149] Non-recoverable alarms may also be referred to herein as system alarms. A repairable alarm allows the user to physically fix the problem (i.e., remove the battery). through the user interface features. The pump may resume delivery. The system alarm may be System alarms stop all processes, including delivery, and prevent users from Disables the interface.

[0150] When the user interface is displaying a screen other than the home screen or when the normal ball When a class or device pre-priming is in progress, in an exemplary embodiment, Alerts and alarm notifications that occur when a normal bolus or device pre-priming is in progress are suspended. If in progress, the user interface will prompt you to or stopped, present a notification, and then the alarm is either The alarm condition itself will cause delivery to be stopped. The user interface will return to the home screen. If you are viewing a screen other than the Home screen, Notifications are suspended. When a recoverable alarm that stops delivery is suspended, the user interface The face only holds notifications, and delivery is stopped as soon as an alarm condition is detected. .

[0151] In an exemplary embodiment where more than one notification is pending, the notifications are presented in order of priority. Additionally, in exemplary embodiments where the companion is used with an infusion pump, All of the warning, alarm, and reminder screens described are also generated on the pump. When the user interface is displaying the home screen and an alarm or recoverable alarm condition occurs, If a condition occurs, the user interface will bring up a caution sequence on the pump, Displays a notification screen explaining the status. If the pump is paused, press the If the pump is not fully configured, notifications on the pump are withheld and the When the companion is awakened and the home screen is displayed, If there is a notification displayed on the pump, the notification will also be displayed on the Companion. The user may dismiss the notification on either the pump or the companion.

[0152] In an exemplary embodiment, the companion is displaying a screen other than the home screen, and the companion When the Companion receives a notification from your pump, it will indicate that there is a pending notification. A flashing notification bar will appear at the top of the screen when the user interface returns to the home screen. If the user has not already dismissed the notification on the pump, the notification will appear on the companion. can be.

[0153] The alarm and recoverable alarm notification are performed in a program called a caution sequence. In an exemplary embodiment, the sequence is: Single tone (emitted from the safety processor speaker), pause, triple tone (emitted from the H8 processor speaker) (or when feedback is set to vibration) In an exemplary embodiment, the sequence begins with the device timing out. Repeat every 15 seconds until the device is restarted or the user interacts with the device, but In some embodiments, the device may be repeated more regularly or less frequently. If there is no user interaction within one minute after the timeout (although in other embodiments, The user interface will wake up the pump and Using a calibrated attention sequence, when feedback is set to vibration switches the feedback to acoustic, and if the feedback was acoustic, The alarm sounds a short tone (from the safety processor speaker), a pause, and a long tone (siren) (H8 escalate to a sequence (through the processor speaker) to repeat the notification. The buzzing sound is a continuous sound with increasing frequency. Once feedback has been applied, the siren When scalated, the sound that follows the attention sequence changes from vibration to sound to siren. If the user interacts with the device after the attention sequence has been escalated, When the sequence emits a sound, the original attention sequence feedback is restored. If the device makes noise for 15 minutes without user interaction while in delivery mode, delivery will be stopped and the device will be deactivated. An automatic alarm notification is generated.

[0154] In an exemplary embodiment, when a user confirms the "Clear" action selection on the notification screen, the notification The notification screen will be cleared and the user interface will close the notification screen. When checking the status again, if the alert or alarm condition still exists, the notification It is repeated.

[0155] When the user approves the "Downtime" item on the notification screen, the user interface displays the pause time setting or allows the user to program and edit the pause time value. Open the Downtime item. You can confirm the "Downtime" action by selecting it on the notification screen. The user-programmable amount of time (from 15 minutes up to 12 hours depending on the notification) The user interface remains inactive until the amount of time specified for Downtime has elapsed. The state is checked again and the warning is postponed. If you change the clock time during a quiet period, the alarm (or check for alarm status) will is adjusted, so that it repeats at rest regardless of clock time. The alarm (or check for an alarm condition) is repeated when a specified amount of time has elapsed between In an exemplary embodiment, the date change is paused. It does not affect the time limit for the warning.

[0156] With respect to clock time and date adjustment, in an exemplary embodiment, the user adjusts the pump clock. When you change the time or date, the pump user interface displays a low insulin alert. All paused alarms, except for the current one, are timed by adding a time or date adjustment to the current time. the time or date set in the current period (if the time or date has been adjusted forward) Adjusted to a time equal to the time minus the adjustment (if the time or date was adjusted backwards) However, in an exemplary embodiment, as described herein, clock time To change the base delivery, the base delivery must first be stopped. When the pump is started, both the idle pump and the low insulin alarm are reset. It will be set.

[0157] Regarding dates, when the user changes the pump date forward in time, the pump user interface The interface is either erased or has not yet expired. Alerts for all user-programmable alerts (except dormant alerts) Generates an alarm. If the user presses the When changing only the pump clock time (without changing the date) to an earlier time, the pump user The interface shall reset the attention alert.

[0158] In an exemplary embodiment, the pump clock time is still unexpired (i.e., (i.e., not cleared or paused), user programmable reminder alarms When the time is changed to a time later than the programmed time, the user interface displays a warning Generates a wake-up alert notification.

[0159] When the user interface is displaying the home screen, alarms, warnings, and If a faulty or recoverable alarm condition occurs, the user interface displays the This brings up a warning sequence and displays a notification screen explaining the condition. Illustrated are examples of alert, reminder, and recoverable alarm screens. If the pump is in a dormant state, the user interface will For embodiments that include a companion, in an exemplary embodiment, the companion On the mobile device, if your companion is awake and you are viewing the home screen, the notification screen will also , also displayed on the Companion. The Companion screen is paused and the pump is displaying notifications. If the user wakes up the companion screen while it is showing, it will resume communication with the pump. When the notification is displayed, it will also be displayed on the companion. Dismisses an alarm or reminder for a programmable amount of time, which the user selects on the notification screen itself. In an exemplary embodiment, a warning screen that cannot be dismissed and can only be dismissed is displayed. There may be some exceptions to this.

[0160] Referring now to FIG. 18A, in an exemplary embodiment, a user may select an alarm or When you approve a downtime item on the reminder notification screen, the downtime settings edit item screen The user approves the downtime item to define the period during which notifications are paused. Now, referring to FIG. 18B, in an exemplary embodiment, the user may select up to six reminders. (However, in some embodiments, the user may wish to You can also program reminders, specify the time, and disable or enable reminders. The user interface may select whether the reminder clock time is set to the time the user When the programmed time changes, it generates a reminder alert for enabled reminders. All reminder time limits are based on the actual amount of time the alarm is paused, minus the user-specified pause time. The user can adjust the pump clock time and / or date to reflect the elapsed time that matches the time between The time is adjusted whenever the user changes the clock time. When the user changes the time of the reminder to a time later than the time programmed by the user, When returning to the screen, the attention is detected and an alert is generated. If you change it to Generates an alert for all enabled reminders that are not paused.

[0161] Bolus reminder will not trigger a normal bolus delivery (normal bolus or dual bolus) The start of the normal bolus (either of the bolus portions) occurs 2 minutes after the activated bolus reminder time. If this occurs within the time limit, the user interface will dismiss the bolus reminder alert. Bolus initiation usually occurs within 2 hours of the programmed bolus reminder time. If not, the user interface will display a reminder alert at the programmed time. do.

[0162] Bolus reminder will not trigger a normal bolus delivery (normal bolus or dual bolus) The start of the normal bolus (either of the bolus portions) occurs 2 minutes after the activated bolus reminder time. If this occurs within the time limit, the user interface will dismiss the bolus reminder alert. Bolus initiation usually occurs within 2 hours of the programmed bolus reminder time. If not, the user interface will display a reminder alert at the programmed time. do.

[0163] In an exemplary embodiment, clearing a reminder does not disable the reminder. When the reminder expires (at a user-programmed time for clock-enabled reminders) (when the time / date change occurs, or when a time / date change causes the reminder to expire), the alarm condition reoccurs The user interface allows the user to access the Alarm Setup: Attention screen. Generates a reminder alert notification until the reminder is disabled via

[0164] The user interface allows the user to change the clock time after the reminder has already expired. Provided that the time is not changed to an earlier time than the warning or the date is not changed, All enabled users will receive one programmable reminder alert notification per day. When the user activates the reminder alert, the time programmed by the user is generated. If it is later than the current clock time, the user interface will Conversely, when the user activates the reminder, the If the user-programmed time of the reminder is earlier than the current time within the current 24-hour period, In this case, the user interface will not generate a reminder alert until the next day.

[0165] 19A-19E, in an exemplary embodiment, with respect to an alarm condition, These include the following: "Occlusion alarm", "Reservoir alarm", "Battery failure alarm", Including, but not limited to, "No Insulin Alarm" and "Inactivity Alarm" .

[0166] Referring to FIGS. 20A-20I, in an exemplary embodiment, with respect to an alarm condition, these are: ,The following alarms are available: "Low Battery Alarm," "Low Insulin Alarm," "Inactivity Alarm," and "Pump Standby" "Status Alert", "Stop Alert", "Cancel Alert" (i.e. the device has "BG Check Alert" (when BG care comment is checked) When the check is enabled, this alarm will sound if 2 hours have passed since the last cannula pre-priming. "Part Change Alert" alert (generated by the user interface when the user When this user programmable care comment is enabled by The interface is based on the frequency of comments from users on the final cannula preparation and site change care items. This alarm occurs when the amount of time between the time specified by the programmable setting has elapsed. "Insulin Temperature Alert" (generates user-programmable care control information), and "Insulin Temperature Alert" (generates user-programmable care control information). When the operation is enabled, the user interface, in an exemplary embodiment, Internal temperatures of 96.8+ / -3.6°F (36+ / -2°C) and A preset threshold temperature of 37.0+ / -3.6 degrees Celsius (2.8+ / -2 degrees Celsius) Insulin temperature alert notification when above or below a preset threshold temperature In an exemplary embodiment, the infusion pump includes a pump The interior of the pump housing or pump body (and the reusable portion of one embodiment of the infusion pump) In some implementations, the disposable portion includes at least one temperature sensor. In some embodiments, the infusion pump includes two or more temperature sensors. The interface is configured to detect when a temperature sensor indicates a temperature change that exceeds a predetermined threshold. In some embodiments, a warning may be displayed to the user. In some embodiments, there may be an alert or alarm. In this embodiment, whether the temperature change was an increase or a decrease determines whether the unintentional transmission There may be a delivery or delivery interruption occurring, and therefore the user should There may be instructions to the user that they should follow the rule. In some embodiments of some infusion pumps, the insulin or Thermal expansion or contraction of the fluid volume may result in the injection or administration of small amounts of bolus insulin or other fluids. To minimize this condition and maintain pump delivery accuracy, The user may be warned to avoid large temperature changes on the pump. The resulting insulin / fluid delivery or interruption in delivery may be caused by users using low basal rates. It has a big impact.

[0167] As described above, the prompt may be displayed by the user in the user interface. In an exemplary embodiment, six reminders are programmed. However, in other embodiments, a greater number of prompts may be issued by the user. Each reminder may be programmed with a designated time for the reminder, a message, and a It includes an indication of whether the prompt is "on" or "off." Therefore, the user can Different alerts within the six alert screens, regardless of which alert is turned on or off On any given day, the user may set up six reminders and save these settings. Any of the reminders may be turned on or off.

[0168] In an exemplary embodiment, the user interface may include options such as "BG check," "Awake," "Basic Includes "Bonus," "Bolus," "Exercise," "Meeting," "Transport," "Snack," and "Medication" Presents a list of programmable values for message items, including but not limited to: 21A and 21B, the 12-hour time display format and the 24-hour time display format are Examples of both reminder display format screens are shown in the time display format.

[0169] In an exemplary embodiment, care comments, such as "insulin temperature," "site change," " BG Check may be enabled or disabled individually by the user. The system will generate a care comment alert at the specified time. Once this care comment is enabled, the pump will automatically shut down if the internal temperature exceeds the set threshold. When the BG check is either above or below the threshold, a care comment alert is generated. For the cannula, this care comment, when enabled, will warn 2 hours after pre-cannulation. Report.

[0170] Referring to FIG. 22, regarding the change of body part, the care comment is The user is prompted to select a frequency based on the final cannula preparation. For example, If set to "3.0 days", the pump will automatically Intermittently accompanied by a site change alert 3.0 days after the most recent cannula pre-preparation.

[0171] Regarding care comments, in an exemplary embodiment, the user interface allows the user to Provides a "Disable All" option that allows you to disable all care comment alerts When the "Disable All" item on the Options screen is set to "Yes", this setting Settings include individual settings for insulin temperature, site change, and BG check care comment settings. Overwrite.

[0172] (Base and pump standby) In an exemplary embodiment, the infusion pump delivers a fluid, or in an exemplary embodiment, insulin, In an exemplary embodiment, the term "basal" typically refers to a unit / its accepted meaning of administration of insulin or other fluid delivered at a "rate" of time The infusion pump will not be automatically stopped by the user using the "Basal Stop" function on the user interface. Also, as described herein, the pump may be placed in a "standby" mode. In some cases, the pump may place itself in standby mode. In addition, in standby mode, the pump stops delivering the basal rate. In embodiments, no insulin can be delivered, and therefore the pump delivery are put on hold or "waiting."

[0173] In an exemplary embodiment, standby mode is required for functions whose delivery may be affected. Functions include date and / or time changes, hardware i.e., reservoir or Replacing the battery and / or changing the basal rate and / or basal frequency currently in use These include, but are not limited to, changes to foundation restrictions.

[0174] In an exemplary embodiment, once the pump is placed in standby mode, the pump may, for example: Alerts the user at 5 minute intervals. This ensures the user that the pump is not delivering. Therefore, the standby mode is a safety measure to ensure that the user is aware of the This is triggered by the pump not delivering, so the user knows the pump is not delivering. This is because the pump will alert the user to standby mode, meaning the user can Ensure ongoing awareness of the importance of

[0175] With respect to power, in an exemplary embodiment, if the pump senses that it has no power, the pump will notify the user that the pump suspects a battery failure exists. However, if the battery is being replaced (i.e., the power supply is being replaced), the user It is recognized that there will be no power during the time it takes to replace the battery. In some embodiments, the user may place the pump on standby while the battery is replaced. This therefore tells the pump that a power outage is expected. The analysis feature helps the pump distinguish between a power outage and an intended power removal.

[0176] This way, the pump will only start charging if the user places the pump in standby mode before removing the battery. The pump allows for silent shutdown (shutdown without notification from the pump). As a safety measure, however, in the exemplary embodiment, the pump has its wait timer The pump will continue to run and at intervals will alert the user that the pump is still in standby mode. Also, as in the exemplary embodiment, this occurs even if the battery or power source is removed. Often, the infusion pump has power to alert the user to a shutdown. This prevents the infusion pump from having a silent shutdown. In addition, the super capacitor / backup power supply is The infusion pump may malfunction during operation, when the power supply is removed, and even before the power supply is replaced. This allows the user to be notified at intervals.

[0177] (Bolus) In an exemplary embodiment, the term "bolus" refers to insulin delivered on demand. The term "normal" bolus refers to a bolus that begins delivery on demand. The term "extended bolus" refers to a bolus that is administered over a user-programmed period. So, for example, a "normal" bolus is 5 0.5U and delivery begins on demand. "Extended" bolus or 5.5U may be delivered over a 2-hour period. A "dual" bolus is a regular bolus and It is a combination of an extended bolus, allowing the user to use the units normally delivered as a bolus, and Specify the time at which the 6.5U dual bolus and extended bolus are delivered. May be delivered as follows: 1 U delivered as a regular bolus, 5.5 U over 2 hours Additionally, in an exemplary embodiment, a bolus, referred to as a "Q bolus," is delivered over a period of time. s refers to a fast bolus, which means that the user interface allows the user to simply scroll or immediately takes the user to a screen to enter the units of the normal bolus. It is.

[0178] Now, referring to FIGS. 23A-23B, various, at least some of the bolus images are Referring first to FIG. 23A, the normal bolus is programmed and delivered using a One way to do this is to use the Bolus menu, which displays the Edit Bolus item selection screen. By selecting a manual item on the screen. Through the Bolus screen, the user You may program Normal, Extended, or Dual Bolus. The value that appears on the screen is , which varies depending on the bolus type selected by the user.

[0179] The extended bolus feature allows the user to specify the length of time the bolus should be delivered. allows for the delivery of a bolus over a longer period of time. When programming an extended bolus without using a pump, the bolus item will be displayed with a dotted line. If you use the food only calculator, the bolus item is set to the calculated carbohydrates. Insulin level is set to Food and Correction or Food & Correction Bolus, and the bolus level is set to The system is set to the calculated carbohydrate insulin value divided by the IOB amount. For any calculated bolus, the bolus amount is calculated using user-programmable bolus increments. Regardless, it is based on the pump delivery resolution (which may vary between pump embodiments). However, when the user changes the calculated value on the Bolus screen, For example, if the calculated value is 0.55U and the bolus increment is If the setting is 1.0U, when the user edits the bolus value, the downward increment will increase the value to 0.0 U and the upward increment changes the value to 1.0U.

[0180] Also, in an exemplary embodiment, the user may change the bolus amount for the extended bolus to 0.0 U. If the duration item is removed from the Bolus screen, the user can deliver a 0.0U bolus. You can accept them, but 0 bolus bolus history will not be generated.

[0181] Dual Bolus allows the user to choose between a regular bolus, which is delivered immediately, and an extended (user-defined) bolus. and an extended bolus delivered over a period of time. When an extended bolus is currently running, the user can If the user changes the amount of expansion of 0.0U, the period adjustment The item is removed from the Bolus screen. The user acknowledges the delivery of the 0.01U bolus. Although it is possible to create a bolus history of 0 boluses, it will not generate a bolus history of 0 boluses.

[0182] Now referring to Figure 23B, the Rapid Bolus screen is shown. The Q Bolus screen displays a programmable number of boluses, allowing the user to quickly program a regular bolus. This allows for programming and bypasses the screen where the bolus type is selected. The rapid bolus is delivered as a regular bolus.

[0183] In an exemplary embodiment, a bolus may not be delivered while the pump is in standby mode. If the user requests a bolus delivery and the pump is in standby, the user interface The pump reminds the user to "start basal before bolus." The bolus is in a standby state, so the user must start the basal before the bolus. It serves to alert the user to the fact that

[0184] Additionally, in an exemplary embodiment, while the pump is delivering the extended bolus, the user may press a second When requesting an extended bolus, the user interface displays the warning "Extended bolus already In progress” to let the user know that they have already programmed an extended bolus. It serves to draw attention to the fact that

[0185] The correction bolus is a bolus calculated using the 1U drip value described above and is Calculate how much insulin should be delivered to bring your blood glucose level to the desired level. In an exemplary embodiment, when correction from bolus is selected, this When insulin profile setting is fast, it is done within 2 hours of the final bolus. or 3 hours after the last bolus when the insulin profile type setting is short If the bolus is taken within 2 / 3 of an hour, the user interface will display "Less than 2 / 3 of an hour since last bolus" The user is still prompted to proceed with the correction bolus process after accepting "OK". The warning screen will prompt the user to press a final button before proceeding with the correction request. It serves to inform the user of the period from the class.

[0186] Now, referring to FIG. 24A, in an exemplary embodiment, bolus data for the entire operating period is When is not available, the user interface displays Displaying IOB values on the home screen, including but not limited to: If one or more of the following is true, the IOB may not contain the entire bolus. " warning is generated.

[0187] 1) The time after the bolus record is initialized is shorter than the operation time programmed by the user. has elapsed and the user confirms the Next Action selection on the Blood Glucose screen (in the exemplary embodiment The pump has been without power for at least 15 minutes and the time and date are dotted when powered on. (When set to , bolus recording is initiated).

[0188] 2) The number of boluses in the bolus history that have been performed with user-programmable operating times is 1 If the IOB value exceeds 0 or exceeds 300, the user confirms the next action on the blood glucose screen. When you do.

[0189] 3) Loss of time and date means that there is no bolus history and the user is unable to select the next When you approve the action selection.

[0190] 4) The user returns to the bolus screen where the calculated insulin value was entered from the blood glucose screen. When you press the button and the IOB value appears with a question mark on the BG calculation details screen.

[0191] Referring to FIG. 24B, in an exemplary embodiment, one or both of the calculators (the correction calculator or Regarding programming a bolus using the bolus calculator (or food and correction calculator), If the volume is calculated to a value less than or equal to 0.0U, the user interface displays the The bolus you received was zero. Cancel bolus? confirmation screen appears.

[0192] Referring to FIG. 24C, when a bolus history is established (in an exemplary embodiment, (established when at least one bolus has been delivered), the user interface IOB still in use to subtract correction bolus from calculated insulin amount If there is no bolus history and bolus recording has been initiated for at least 2 hours (when insulin profile setting is fast) or 3 hours (when insulin profile setting is fast) If the time limit (when the file setting is short term) has not yet elapsed, the user can use the correction calculator. When programming a bolus using the bolus menu, the user interface - When accepting a Food & Correction or Simply Correction item on the screen, the message "Last bolus time is incorrect" appears. A confirmation screen will appear asking, "This is clear. Do you want to continue?"

[0193] Referring now to FIG. 24D, in an exemplary embodiment, the user interface User-programmable settings, maximize bolus limits (Bolus Limit Setup) The maximum bolus is given to all types of bolus, defined by the user interface. The interface is designed to allow users to use at least one of the following, but not limited to: When performing an action, the message "Maximum bolus for [nn.nn]U has been exceeded. Please remove the bolus." appears. A confirmation screen will appear asking, "Do you want to delete this?"

[0194] 1) Using either the correction or food calculator, program the bolus and maximize the maximum bolus. Attempts to deliver a bolus with a calculated insulin value that exceeds the bolus limit. In the message text, [nn.nn] is the value of your Max Bolus Limit setting (setup The user interface will display "Bolus Limit" when the user selects a food or blood glucose limit. Select "Next" above to have the bolus calculation begin with the user-programmable maximum bolus limit. When the setting is exceeded, a confirmation screen will be displayed.

[0195] 2) Program a dual bolus and set the total bolus volume to Maximum bolus amount exceeded. The user interface will notify you that the combined bolus amount is The user will receive a dual bolus when the maximum bolus limit set by the user is exceeded. When selecting delivery on the screen, a confirmation screen will be displayed.

[0196] As described above with respect to the home screen, the user interface is In a preferred embodiment, the unit and final The amount of time that has passed since the bolus may be displayed on the home screen. In one embodiment, the user interface includes a series of history screens. When the user accepts a history item on the Bolus or Reports menu screen, The user interface displays the history of n screens. The user can select the 10 most recent A historical breakdown of delivered boluses may be viewed over time. In other embodiments, this feature may be used to The 11 or more most recently delivered boluses may be available using the History screen. Completed boluses, including regular (including 1-button and Q boluses) and extended boluses The records are sorted by time of completion, with the most recently completed bolus listed first. Thus, the user interface may display the units, bolus type (e.g., normal Records the last 10 bolus events, including the time since the bolus was completed (e.g., extended, etc.) and the time since the bolus was completed. Provides easy access to records.

[0197] (Diary and Report) Referring now to FIG. 26, in an exemplary embodiment, the Reports menu screen includes a Pump Logbook. and bolus history. After the pump is fully initialized, the user Select Reports on either the Main Menu screen or the Activity-Based Home screen. On the pump, technology access is enabled. When you do this, the Reporting menu screen will have a Send Logbook option to send your pump records to your PC. These are described with respect to Figures 31-34D.

[0198] Referring now to FIG. 27, in an exemplary embodiment, a user selects When selecting and approving a pump journal item, the user interface displays the journal entry. Displays the Pump Logbook screen from which the user may choose to view or send the

[0199] Now referring to FIG. 28, in an exemplary embodiment, a user can select treatments on the pump diary screen. When approving an item, the user interface displays the current day's daily treatment summary screen. (In an exemplary embodiment, a 24 hour period beginning at 12 AM) Treatments per day The summary screen is sent for that 24-hour period, excluding any volumes delivered through device pre-priming. The total daily dose is given, including all basal and bolus doses. Therefore, with an extended bolus, the total daily dose is the sum of the extended bolus doses delivered within a 24-hour period. Users can scroll through daily treatment summaries for up to 30 days. The first input is the current calendar date, and the 30th input is , 30 calendar days ago. For example, if the current date is June 14, 2008, The first daily treatment entry was on June 14th and the 30th entry was on May 16th. If there is no delivery data in the treatment diary for the 29 days prior to the current date, the user The interface displays the daily treatment time from the current date to the earliest date in the treatment diary. The treatment summary screen is displayed.

[0200] The treatment diary is read backwards in time from the most recent date. While doing so, the user interface encounters an entry for a date that is later than the last event retrieved. If the delivery data for that day (the date of the last event read) is found to be an earlier date, All input is considered to have been ignored until the given date. When not present, the total daily dose summary for that date is 0.0 U and the % basal dose is 0.0 U. The system disappears from the Treatment Summary screen.

[0201] Summary of the day if the logbook entry indicates a non-zero basal rate when a power-on event is encountered The details are removed from the treatment summary screen and "Invalid Data" is displayed instead. 12A if it is the first day of pump use and the first basal delivery begins after 12 AM The period between M and the first basal delivery date is represented as 0.0 U / hr. Between the time you acknowledge the therapy item on the pump log screen and the end of the current 24-hour period Duration is also expressed as 0.0 U / hr.

[0202] 29A and 29B, in an exemplary embodiment, a user may When acknowledging an incident item on the journal screen, the user interface will Displays the Event Summary screen for the pump event that occurred. The Event Summary screen displays the date and time the event occurred. Displays the time and a description of the event, which may or may not include additional details, depending on the event. For example, delivery includes programmed amounts and delivered amounts, and is expanded. Other events, such as a bolus and a temporary basal, include a duration. An event summary screen for the event may be displayed (although in other embodiments, (i.e., more than 150 events may be visible), The events are ordered from most recent (first input) to least recent (last input).

[0203] Referring now to FIG. 30, in an exemplary embodiment, a user can select an alarm on the pump log screen. When approving a team item, the user interface displays the most recent repairable or repairable Displays the alarm summary screen for non-recoverable alarms. The user can view the alarm summary screen from the past. You can also scroll from the alarm.

[0204] Now, referring to FIG. 31, in an exemplary embodiment, when technology access is enabled: The report menu screen includes a journal sending item. When approving a send item, the user interface displays the Send Journal screen. The user may then select from a list of records to send to the PC.

[0205] Referring now to FIG. 32, in an exemplary embodiment, a user selects a date on the Reports menu screen. Approve the journal submission item, then click any button other than "Done" on the submission journal selection item screen. When approving an item, the user interface asks "Is your PC connected?" The user interface displays a confirmation screen, prompting the user to "Transfer another record?" After selecting "Yes" on the confirmation screen, the log sending screen will be displayed and the user can select any action other than "Complete" When selecting an item, the "Is a PC connected?" screen does not appear.

[0206] Now, referring to FIG. 33, when technology access is enabled, the user can create a journal entry. In an exemplary embodiment, while transferring a diary entry, the user may Choose to write the resulting recording file to your PC in ASCII format. The user can select "Yes" on the "Is your PC connected?" confirmation screen. After confirming that the PC is connected, the user interface will display "A A confirmation screen will be displayed asking, "Is it in scii format?"

[0207] Now, referring to FIG. 34A, in an exemplary embodiment, once technology access is enabled: The user may then send the journal entry to the PC. While transferring the journal entry, the user Choose to prepend configuration information to the resulting recording file on your PC. The user can select "Yes" or "No" on the "Is it in ASCII format?" confirmation screen. After selecting ", the user interface will ask "Do you want to prepend configuration information?" Display the screen.

[0208] Referring now to FIG. 34B, in an exemplary embodiment, when technology access is enabled: ,The user may send the diary entry to the PC. While transferring the diary entry, the user You may choose whether or not to include the recording number in the resulting recording file on the PC. The user selects "Yes" or "No" on the "Do you want to prepend configuration information?" confirmation screen. After making a selection, the user interface displays a "Include Record Count?" confirmation screen. .

[0209] Now, referring to FIG. 34C, in an exemplary embodiment, once technology access is enabled: The user may then send the journal entry to the PC. While transferring the journal entry, the user , you may choose to clear the records on the pump. When the transfer is complete, the sending screen will ask "Transfer completed. Do you want to delete the record?" Move to the screen.

[0210] Now, referring to FIG. 34D, in an exemplary embodiment, once technology access is enabled: The user may then send the diary entry to the PC. Once a record has been transferred, The user interface displays the "Transfer another record?" screen. If "Yes" is selected, the user interface returns to the Send Journal menu. Infusion Pump System 35-36, the infusion pump system may be No. 6,239,999, filed Oct. 10, 2008, entitled "Integrated Circuit Interference Module," which is incorporated herein in its entirety. Fusion Pump Assembly, U.S. Patent Application No. 12 / 249,882 ( In some embodiments, the cart may be similar to those described and shown in The ridges may be ridges and / or syringe-like reservoirs as shown in FIG. 35. At least one reservoir 3500. However, in some embodiments, the reservoir The infusion pump system includes a pump unit adapted to contain a fluid intended to be infused. In some embodiments, the reservoir may be any component of the system. The patent application was published on January 20, 2007, and is currently U.S. Patent Application Publication No. US-2007-0219480. Patent application filed on February 9, 2007, entitled Patch-Sized Fluid D Delivery Systems and Methods, U.S. Patent Application No. 11 / 70 No. 4,886 (E72), published December 3, 2009, and now U.S. Patent Application No. Publication No. US-2009-0299277, filed December 31, 2008 , U.S. Patent Application No. 12 / 347 entitled Infusion Pump Assembly ,985 (G75), which are also described in the reference and the like, all of which are incorporated herein in their entireties by reference thereto.

[0211] In some embodiments, the system includes a step of connecting the inlet tube 3504 to the reservoir 3500. In some embodiments, the device may include at least one hub 3502 or the like for connecting the device to the network. In some embodiments, the infusion tube 3504 pierces a septum within the cannula 3510. It may include a connector needle 3508 for piercing, or a connector 3506. The nula is an infusion tube that allows fluid in the reservoir to be infused through it into the user / patient. Any cannula known in the art for connecting a probe, or any other suitable Such a device may be used.

[0212] Still referring to FIG. 35, the system includes at least one pump 100 . Again, as described above, the pump may be any infusion pump, or In some embodiments, the method shown and described with respect to FIGS. 1A-1F or 2A-2D may be used. or any of the various references incorporated by reference. However, in other embodiments, the pump may be an infusion pump. In some embodiments, the pump 100 may be a battery 3512. and may also include a battery cap 3514. In some embodiments, the reservoir 3500 may also include a removable reservoir. The plunger may include an external plunger handle 3516, some embodiments of which are described in detail below. and filed October 10, 2008, which are incorporated herein in their entireties by U.S. Patent Application No. 12 / 249, entitled Infusion Pump Assembly, 882 (F51). In some embodiments, the system includes a companion The pump may include two or more pumps, which may be paired with one another.

[0213] Referring now to Figure 36, an embodiment of a companion 300 is shown. As discussed above with respect to various embodiments of the companion 300, The system may include a bridge 302 and switch assemblies 304, 308. In this embodiment, the companion 300 also includes a blood glucose strip reader 314 in some embodiments. It may also include a strip reader 312. However, in some embodiments In this state, the strip reader 312 tests / determines the presence of any analyte in a bodily fluid or other fluid. As mentioned above, the companion may also be adapted to be used for Additionally, in some embodiments, at least one continuous glucose sensor and / or a receiver for at least one continuous analyte sensor, which may be one or more other sensors; include.

[0214] The system includes both a companion and a pump with a display. In an embodiment, the pump and companion user interfaces include nearly identical screens. This allows the user / caregiver to have one set of screens / one user interface. Learn all aspects of the pump from either the pump or companion or both In addition, it may be desirable to have the pump and the The companion also ensures that all functionality of the system is maintained by either the pump or the companion. It may be desirable to have the infusion pump accessible through the In some embodiments, the user may choose to wear the device under their clothing. Through the companion you can program and access all the functionality of the system. Thus, in some embodiments, all of the screens / functions described herein may be may be accessible on both the companion and the pump. In some embodiments, the pump may not include a display screen.

[0215] Now, referring to Figure 37A, a target range of analytes may be input into the system. In some embodiments, this information is provided to the companion and / or pump and / or may be entered into both the companion and the pump. The sensor may include a strip reader and / or a receiver for a continuous analyte sensor. The user / caregiver may, in some embodiments, monitor blood glucose and / or interstitial glucose levels. You may choose to enter a target range of analytes. In some embodiments, the target values may include a low target and / or a high target, although in other embodiments In some embodiments, the target value may include the mean and / or median, and in other embodiments, The target value is at least one of targets such as diet, exercise, disease, and sleep. In some embodiments, the target may include, but is not limited to, a target of a specific event. The target value may be input into the companion and / or pump. The target is further time points, e.g., 2 hours after a food bolus, 1 hour after exercise, 1 hour after sleep, etc. The specificity may include, but is not limited to, specificity regarding the time elapsed since the event.

[0216] Now, referring to FIG. 37B, in some embodiments, the target is input with respect to time. For example, in some embodiments, at least one blood glucose (“BG”) marker may be The target may be input in terms of time (see 3700-3704 in FIG. 37B). Once this information is entered by the user / caregiver, the block is completed and the result is 37. In some embodiments, this also Similarly, time targets are events, i.e., the time elapsed since the start of the event, and / or or may relate to the time elapsed since the end of the event.

[0217] Now, referring to FIG. 38, in some embodiments, various events may be triggered by a companion and / or may be input to the pump and / or companion and pump These events include: insulin / fluid / medication, food, exercise, health status, and / or or may contain information about one or more of the general / customizable events Regarding the user interface, the history / input of the event An event type may be selected for viewing from the event history menu 3800. Insulin 3802, Food 3804, Exercise 3806, Health 3808, and General 3810 10 shows examples of some embodiments of an event history screen. In some embodiments, The event history screen includes a scroll function, so that by scrolling, you can It may be possible to view a history list containing one or more previous events. The ability to input events and information related to those events may be desirable for many reasons. For example, the user / caregiver may enter the date / time, duration, and type of exercise. This includes the volume of fluid infused and the pre-event, intra-event, and post-event specimens / groups. Therefore, event records can be useful for later review of both the radiation trace data and the treatment. This system can be useful for reviewing treatments and outcomes to suggest treatment changes. For this embodiment, the companion receives glucose data and controls the insulin pump. In some embodiments, the device may either control a blood pressure monitor or control an insulin pump. In this condition, information on both glucose and insulin delivery is highly desired by users. This may provide users with a means for improved health or more convenient treatment.

[0218] In addition to those embodiments described above with respect to the Reports menu, see now FIG. 39A. Your companion and / or pump will then display your BG history, line graph, and BG statistics. Additional embodiments of the Reports menu 3900 include, but are not limited to: In some embodiments, the desired report may be highlighted, as shown in FIG. This helps select the report. In various embodiments, the report may be a report of additional or other analytes, which may not be the analyte. However, regardless of the type of specimen, the One or more embodiments of the reporting may be used. In other embodiments, one or more serial samples / Additional reports on glucose sensors may be available.

[0219] Referring to FIG. 39A, in some embodiments, even if BG statistics reports are available, Statistical reports include the number of blood glucose checks per day, average blood glucose, standard deviation, and / or or number of hypoglycemic readings, number of hyperglycemic readings, etc. Additionally, in some embodiments, one or more continuous glucose sensors and / or In various embodiments, similar statistics regarding sensors transmitting data to a companion may be collected. In some embodiments, and as shown in FIG. 39A, For example, 7 days 3902, 14 days 3904, 21 days 3906, but limited to these Statistics based on averages over a given number of days may be presented to the user / caregiver. However, in some embodiments, there may be additional or different day values. and / or number of days may be customized / requested by the user / caregiver, That is, the number of days may be input or may be user-specified at setup time or at other times. may be pre-programmed as a customizable feature.

[0220] Now, referring to FIG. 39B, in some embodiments, a line graph report is selected. In some embodiments, the time period may be, for example, 2 hours, 4 hours, 6 hours, or the like. etc. may be selected, and a date may also be selected (3910). In this embodiment, for the day, a time, e.g., 3 pm, is selected (3912), and the scrolling Thus, a single screen may be displayed showing both selections during a particular time period as shown in FIG. 39B. The line graph may show a selected / specified time period, for example, two hours. However, in various embodiments, the line graph may be This can be useful to provide trend data for

[0221] Now referring to FIG. 39C, in some embodiments, if BG history reporting is selected, In some embodiments, the predetermined number of days may be It may be stored on the panion and / or pump. Thus, in some embodiments In some cases, the extended history may be uploaded to another device, e.g., a PC. In this embodiment, BG History displays one blood glucose / test strip reading per screen. In some embodiments, the BG history may include the date and time (3916). includes a scroll feature, where various blood glucose readings are displayed in chronological or reverse chronological order. You may scroll either way.

[0222] Still referring to FIG. 39C, if the blood glucose reading is lower than the preset target, or higher than a preset target, in some embodiments. The BG history may include an indication thereof 3918. In some embodiments, the BG history may include an indication of the blood glucose test. When a reading is displayed, the user is prompted to enter comments about the reading that may appear on the BG history. This can be done by taking into account the following: high, low, exercise, stress, illness, menstruation, different foods, etc. In some embodiments, the method may include, but is not limited to, one or more of the following: These comments may be customized, so that the user can add any comment In some embodiments, the character length of the comment may be limited, In other embodiments, the character length may not be limited.

[0223] Again, injected fluid data and co-located detection data are used. The availability of body sensor / analyte / strip reader data is crucial to the safety, efficacy, and safety of the treatment administered by the user. This system can improve the ease and quality of the process, thus improving efficiency, effectiveness, and safety. The present invention can be an infusion pump system with the improvements.

[0224] Referring now to FIG. 40, as described above, in some embodiments, the system Various components of the system may be customizable. An example is shown in Figure 40. In some embodiments, the system " menu option. It may be used to input customizable features. For example, a base program / base profile may include a customizable name. In some embodiments, a "Custom" or similar menu option 4000 may indicate that the user / caregiver wishes to program a name into the system. In some embodiments, the system includes a text / number entry screen 4002, where the user Allows you to select number / letter combinations for customized names 4004 You may do so.

[0225] In various embodiments, one or more menus may invite the user to select "Custom." and / or users may customize the comment and / or name. These may include bolus comments, exercise comments, illness comments, Stress comments and / or specific sample values / blood glucose readings / continuous samples / groups This can be a course monitor value or a comment associated with the selected time. By making it easy to enter comments into the system, The app allows you to easily and simply customize your inputs, so you can easily choose the right one for you, such as "exercise", "different foods", and / or "stress" pre-programmed into the pump as a comment on glucose values If possible, the user may choose to use words like "skiing," "pizza," etc., which are more descriptive / indicative of the user's life. and / or you may choose to enter "last" and therefore investigate trends. may be useful to the user / caregiver when recommending / identifying changes to treatment and The system accepts text inputs such as comments, profile / program names, etc. Make it possible.

[0226] Customizable names can improve the quality of care for users. but pre-programmed for basal rate / specific exercise programs, days of the week and / or periods. If it is acceptable, users should name their programs in a way that makes sense to them. This allows the user to determine which is most effective in treating a particular event and / or time. The user can easily associate the program with the program and select the program quickly and easily in the future. From the basic program entitled "Weekend" that may be available in the general menu Rather, the user may create specific categories for "ski weekend," "camping weekend," "winter weekend," etc. Basal rates may be pre-programmed, all of which contain different basal rates / programs. That's fine.

[0227] Referring to FIG. 41, in some embodiments, adding an event can be done from the home screen. This may be an option on a main menu that can be easily accessed from the In some embodiments, as described above, the addition of events may improve treatment, and thus events The ease with which comments can be entered, e.g., the user / caregiver can quickly reach the point where a comment is entered. Fast and convenient access may contribute to the frequency with which users / caregivers enter events. Therefore, ease of access may be desirable for users / caregivers to access the treatment. It may be encouraged to exhibit the most optimal possible behavior.

[0228] Referring now to FIG. 42, in some embodiments, the system may include a Now, a medication event, which may be an "insulin event" 4200, as shown in FIG. However, in some embodiments, the input The names of the medications may vary depending on the application of the system and / or user preference. In some embodiments, the event menu 4200 includes additional, and in some embodiments In some embodiments, the menu may include customizable categories of medications. The new 4200 may include a "Medication Events" option.

[0229] In some embodiments, a medication event is selected from the event menu 4200. The caregiver is prompted to enter the type and amount (in the case of insulin, the type and "units"). However, for example, if the user has taken a pill, In embodiments where the user enters the number of pills taken, the user may, for example, enter the number of pills taken. In some embodiments, the user may click You may also select "Done" (4206).

[0230] In various embodiments of the system where the pump is an insulin pump, the insulin delivered Phosphorus is delivered either as a basal or bolus and is pumped by a pump. The fluids contained therein are automatically tracked and recorded, and various history and logbook features are described herein. However, in some cases, the user may inject insulin. For example, a user may use a pump for bolus delivery and an injection for basal delivery. Alternatively, the user may use a blood glucose meter and / or a continuous A companion device may be used as a radiosensor receiver, but multiple injections per day may be required. In these cases, the user / caregiver may receive insulin therapy through Therefore, it may be desirable to enter the type and units / volume to be injected. In this case, the system will require a note to document the insulin delivered by the pump. It may also include options for insulin to be injected and entered into the system, for example: In some embodiments, the user injects a bolus of insulin and controls the time, amount, and duration of the injection. When entering a type of sling into the system, for example, if the type is high speed, the system The input may be used to calculate the insulin being administered. If the user is injecting basal insulin, e.g., NPH or LANTUS, The system can tell the user the time of the next delivery, for example, up to 12 hours after the injection of basal insulin. Alternatively, an alarm may be issued 24 hours later.

[0231] Now, referring to Figures 43A-43C, in some embodiments of the system, A menu for setting the alarm may be included in 4300. The alarm settings may be the same or different for the companion and pump. In some embodiments, the companion alarm settings are separate from the pump alarm settings. In some embodiments, either the companion or the pump may It may contain many and / or different options. In some embodiments, the alarm sound and / or vibration itself may be useful to indicate the nature of the alarm. To obtain, it may be desired.

[0232] Now referring to FIG. 43B, in some embodiments, the companion alarm may: It may be set separately from the pump alarm. As shown in FIG. 43B, some implementations In form, alarms may be audible / vibration, inactivity, occlusion, attention, and / or care instructions. The alarm setup screen 4302 may include, but is not limited to, It may include, but is not limited to, one or more of the various categories shown.

[0233] Regarding the audio / vibration alarm setup, in some embodiments, the companion and The pump and / or pump alarms may include, but are not limited to, acoustic, vibration, and / or audible sounds. Not limited to (4304). In some embodiments, each of these alarms: In some embodiments, these may include, but are not limited to, low, medium, high, short, and long. , may include one or more options (4306, 4308). Although the embodiments refer to a companion, in some embodiments the same alarm set The same approach may be applicable to the pump, and in some embodiments, The alarm setup may be applicable to another device. Once the alarm setup is complete, the alarm setup is This may be applied to all devices.

[0234] Now, referring to FIG. 43C, in some embodiments, the pump and / or Panion alarm / vibration options may vary. These may vary between devices. For example, in some embodiments, alarm / vibration The menu may include the pump alarm and the option for high or low ( However, in other embodiments of these embodiments, the pump Alarm / vibrate may include additional options.

[0235] Now, referring to FIG. 44, in some embodiments, the user / caregiver may In some embodiments, a user may select a preference from one or more options regarding The preferences may be related to the display and / or the home screen. Out (e.g., seconds), cursor (e.g., highlight or magnify), home screen, Many display options, including but not limited to, last, composition, color, photography, etc. Therefore, in some embodiments, the system may It allows you to choose different display options based on your preferences.

[0236] Regarding the home screen, different users prefer different information on the home screen, so options are Many options for the home screen exist and some implementations In this state, the following options are available: Time, Date, Quick Bolus, Food Bolus, Main Menu Selection, Last bolus, final blood glucose or strip reader value (or in some embodiments also final (which may include the time elapsed since the last value, the most recent strip reader value), strip reader value / blood Glucose line graph, stopped basal, stopped bolus, bolus progress, continuous glucose Sensor / Continuous Sample Sensor line graph, current basal rate, loaded insulin, daily Total bolus per day, total basal per day, battery index, communication index, reservoir capacity index, and / or one or more of the provided basal profiles, In some embodiments, the user may select the home screen information, including but not limited to: You may select both the information and / or the color / presentation of the home screen.

[0237] Referring again to FIGS. 3 and 36, in some embodiments, switch assembly 3 At least one of the buttons 04, 308 may be used as a "bolus button." In some embodiments, another input device may be used as the bolus button. The base button may, in some embodiments, be a device according to the present invention. Infusion Pump Assembly, U.S. Patent Application No. 12 / 249,888 2 (F51), and published on December 3, 2009, now U.S. Patent Application Publication No. No. S-2009-0299277, filed on December 31, 2008, entitled Infusion Pump Assembly, U.S. Patent Application No. 12 / 347,985 (G75), both of which are incorporated herein by reference. and are incorporated herein in their entireties.

[0238] In some embodiments, the food bolus or insulin to carbohydrate ratio ("I:CH") While programming a bolus containing an I : You may be prompted to confirm CHO. In an example, referring to FIG. 45, To program the , in some embodiments, the user accesses the main menu 4500 Select "Bolus" from the menu, then select "Food" from the Bolus menu 4502. The user may then enter the number of grams of carbohydrates (4504). In this embodiment, once the carbohydrates are entered, the user may click "Next" rather than "Next." The user may then select "Details" 4508. The user may then approve or decline the current I:CHO. This allows the user to easily and conveniently view the current I:CHO and It may be desirable to have the option to modify the I:CHO of the current food bolus. In some embodiments, changing I:CHO during the food bolus does not affect any previously pre-existing Programmed I:CHO may not be reprogrammed, but rather modified I :CHO may only be used for the current food bolus calculation.

[0239] This embodiment of the food bolus leads to more accurate treatment recommendations by the bolus calculator. In some embodiments, I:CHO is preprogrammed and in some embodiments In some embodiments, multiple I:CHOs based on time of day may be pre-programmed. In some cases, the user may modify the I:CHO for a given food bolus based on an event. Therefore, the user may decide to change the I:CHO for a given event. In some embodiments, the user may wish to navigate through different menus to It may be necessary to change I:CHO for a given time frame and then return to a food bolus. However, changing the I:CHO of the intended single-time bolus is This may have the effect of changing the I:CHO for a given time frame. If you do not change I:CHO back to its previous value, the bolus calculator will calculate based on the saved value. This may lead to future over- / under-delivery.

[0240] Additionally, users may wish to avoid changing stored I:CHO values. In this case, the user may be hesitant to change the I:CHO of the food bolus. This allows the user to perform a manual bolus or change the recommended amount of insulin. Again, this can lead to over / under delivery. It is possible.

[0241] However, in the embodiment shown in FIG. 45, the user may select I: The CHO may be changed, so this may require further adjustments for accuracy of the single food bolus. Therefore, it is more convenient to change I:CHO without changing the programmed I:CHO value. This method can be a safe and reliable method to prevent accidental changes to previously stored I:CHO values. This can prevent over / under delivery.

[0242] Now, referring to FIG. 46, in some embodiments, once the bolus is programmed, Once activated, a "Delivery" screen 4600 appears. In some embodiments, the delivery screen In some embodiments, a bolus progress indicator is provided, showing real-time progress of the delivered volume. In some embodiments, the total bolus required may be indicated. As such, in some embodiments, the delivery screen 4600 displays the volume of the delivered bolus. Amounts, e.g., 2.50, as well as required amounts, e.g., 5.20 U, may be indicated. Thus, the user / caregiver is informed of the progress of the bolus delivery.

[0243] In some embodiments, the delivery screen 4600 also includes a "Stop" option. In some embodiments, and as shown in FIG. 46, the user / caregiver may If you select Cancel or "Stop" in some embodiments, the pump and / or or any input device on the companion may "stop" the bolus. The option may be highlighted, which in some embodiments may be programmed If the bolus volume is not desired, this embodiment allows the user / caregiver to and / or any input device on the companion to quickly stop / remove the bolus. It may be desirable to be able to cancel the

[0244] If an ongoing bolus is stopped / cancelled, in some embodiments, a "Stop The "Alert" screen 4602 indicates this to the user / caregiver. In the embodiment shown in FIG. 46, the user is informed that the bolus, or in the embodiment shown in FIG. 46, the normal bolus, has been stopped. / Alert the caregiver. In some embodiments, the user / caregiver exits the alert screen. As with any alert, in some embodiments, the alert The information screen may be accompanied by an audio and / or vibration indication. The guard may choose to have an audio and / or vibration indication accompany the alert screen as part of the user preferences. You may choose.

[0245] In some embodiments, and as shown in FIG. 46, when the alarm is cleared, the device The display may return to the home screen 4604. As shown in the embodiment of FIG. The home screen may also show the last bolus. In this case, the bolus is displayed as shown in FIG. If a service is stopped / canceled, the home screen will display the delivery amount as well as the requested original. As shown in FIG. 46, the home screen 4604 may display the amount of "Last Bolus" 3.40 0 hours 00 minutes before 5.20U. Therefore, in some embodiments, This prompt clearly informs the user / caregiver that the bolus has been stopped and In some embodiments, the total amount delivered in the final bolus is clearly indicated. As shown in Figure 46, even if more than 3.40 U of insulin is loaded, This embodiment provides an alert to the user / caregiver when the bolus is stopped, Prompts the user to "Clear" and also provides a complete status of the last bolus on the home screen. Therefore, in some cases, it may be desirable for the user / caregiver to stop an ongoing bolus. If the bolus is stopped unexpectedly, the user / caregiver is alerted to the fact that the bolus has been stopped and the total The amount delivered may be indicated on the home screen. This is indicative of the fact that the bolus has been stopped, Additionally, a safety feature is provided to fully inform the user / caregiver of the total amount delivered before the bolus is stopped. This can be a useful method.

[0246] Now, referring to FIG. 47, in some embodiments, an extended bolus is programmed. Once programmed, in some embodiments, the home screen 470 0 indicates the progress of the extended bolus, e.g., "Extended bolus 2.00U 0.10 0 time 0" In some embodiments, the extended bolus may be administered over a period of time, e.g., 2 minutes. Time may be ongoing, and therefore an easily visible indicator of progress is desirable. Additionally, an indication of the total amount delivered may be provided to the user when making treatment decisions during the extended bolus. / May be desirable for caregivers.

[0247] Still referring to FIG. 47, in some embodiments, the user / caregiver may If the user / caregiver wishes to stop or cancel the extended bolus, the user / caregiver must Menu 4702 may be navigated to, and in some embodiments, is shown in FIG. On the home screen 4700, navigation to the main menu is done using the input device This may be achieved through a "Main" selection, with "Main" highlighted and therefore easily selectable. do.

[0248] Once in the main menu 4702, in some embodiments, within menu 4702 The first highlighted option is "Stopped". By selecting "Stop" , navigated to a "Confirm" screen 4704. In some embodiments, the confirmation screen 470 At the bottom of 4, a "Yes" and "No" option may be included. In some embodiments, such as the one above, "Yes" is highlighted.

[0249] If "Yes" is selected in the confirmation screen, the extended bolus is stopped. In this example, the home screen 4700 displays, for example, an extended bola that has 0.10 of 2.00 delivered. In some embodiments, this may be updated to indicate the final bolus. This is similar to the method described above for a canceled bolus. If the user navigates to "No," If you select "No," in some embodiments, the home screen Surface 4700 appears and the extended bolus continues as programmed.

[0250] Thus, in some embodiments, the user / caregiver may select one of the input devices If you want to stop the extended bolus via the 2 options, e.g., switch Pressing navigates to a confirmation screen, which allows the user / caregiver to cancel the extended bolus. Additionally, a confirmation screen may be desired to allow the user / caregiver to "stop" " menu and select "Yes" to stop the extended bolus Additionally, in some embodiments, a user may need to manually stop the extended bolus. To do this, the user / caregiver must select "Yes" in the confirmation menu. In embodiments, this may reduce the risk of inadvertent stopping or cancellation of the extended bolus delivery. , may be desired.

[0251] Referring now to Figures 48A and 48B, various implementations of a method for suspending a foundation are shown. In some embodiments, navigation to stop the base Even if you go through the main menu, stop option (see Figure 47, 4702) As shown in FIG. 48A, in some embodiments, a confirmation screen 4800 may include a Includes highlighting of the "Yes" option and navigates the user / caregiver to the "No" option The "No" option is selected, as shown in Figure 48A. In this case, in some embodiments, the home screen 4804 is shown.

[0252] Now, referring to FIG. 48B, in some embodiments, a navigation system for stopping a base Navigation is through the Main Menu, Stop option (see Figure 47, 4702) As shown in FIG. 48B, in some embodiments, a confirmation screen 480 6 includes highlighting of the "No" option and directs the user / caregiver to the "Yes" option You may be prompted to navigate. As shown in Figure 48B, the "Yes" option is selected. If selected 4808, in some embodiments, a home screen 4810 is shown. As shown in home screen 4810, when the basal is stopped, home screen 4810 In some embodiments, the message "Basal stopped 0 hours 00 minutes ago" is included. .

[0253] Thus, in some embodiments, this indication on the home screen 4810 indicates that the clearly notify the user / caregiver that the service has been stopped and This embodiment clearly shows the total elapsed time. When the device is activated, a confirmation screen is presented to the user / caregiver, prompting the user to select "Yes." It may be desirable to prompt the user to navigate (4808). Now, the user / caregiver can navigate to the "Yes" option to confirm that the user / caregiver is You must confirm that you want to stop delivery, so you can avoid accidentally stopping your basic delivery. Additionally, if basal delivery is intentionally stopped, in some embodiments The home screen 4810 shows this information and also displays the time since basal delivery stopped. This may indicate the fact that basal delivery has been stopped and also the amount of This can be a safe way to fully inform the user / caregiver of the total amount of time since Therefore, the user / caregiver can now make decisions based on this easily and fully accessible status information. It may be possible to better determine subsequent treatment.

[0254] Additionally, in some embodiments, the user / caregiver may must select "Yes" in confirmation menu 4806 to stop basal delivery. In these embodiments, this may reduce the risk of accidental stopping or cancellation of basal delivery. It may also be desirable for the system to deliver insulin to a user with diabetes. In the embodiment used, stopping basal delivery may pose a risk to the user. Therefore, it is important to ensure that users are fully informed of this occurrence and that the It may be desirable to ensure that stopping is not easily achieved inadvertently. If basal delivery is selected to be stopped, and there is an ongoing extended bolus, the system The system requires the user to press the extension button before the system will allow the user to stop on a daily basis. The user / caregiver may be prompted to stop the course. This may be done in some embodiments. If the user / caregiver wishes to stop the administration on a daily basis, i.e., the total amount of fluid If all regular deliveries are stopped, the user / caregiver must be aware that an extended bolus is in progress. Therefore, in some embodiments, As a safety step, the system allows the user to stop daily basal delivery. The user may be required to stop any extended bolus before allowing the flow. This may prevent over-delivery or unintended delivery to the body and, in some embodiments, may If the device is an insulin pump, unintended over-delivery of insulin may be prevented.

[0255] 49A and 49B, an embodiment of a companion self test In some embodiments, the companion self-test is However, in some embodiments, On-self tests are performed, for example, following pairing with a new pump, on first use, After battery charging or battery replacement and / or pre-programmed A time schedule, for example, one or more of every 10 days, or daily, or monthly. It may be performed on a pre-programmed schedule, including but not limited to: Self-testing may be performed to ensure the companion is functioning properly. For example, to demonstrate that one or more components function as expected. ,Components include, but are not limited to, the following: display, sound, vibrator, backlight The device may include one or more of a light, a test light, and a memory function. The self-test may diagnose or predict companion failures, so some In embodiments, it may be desirable to ensure user safety.

[0256] Now, referring to FIG. 49A, in some embodiments, a user may access the home screen 49 Navigate from 00 to the main menu 4902 to set up your companion. In some embodiments, the main menu may include The user may also include a "Self-Test" option. 49B, the self-test In some embodiments, the companion may self-test When performing a self-test, the companion display will display the self-test steps in progress, e.g. , "Check the display" (4906), "Check the sound" (4908), "Check the vibrator "Check" (4910), "Check Backlight" (4912), "Check Test Light" (4914) In various embodiments, the self-test may indicate "Check Memory" (4916). The steps in the method may vary and may include fewer or additional steps. In some embodiments, the user may configure the companion so that its components are predicted. You may choose to order a self-test if you are concerned that the device is not functioning properly. Self-tests diagnose potential or ongoing faults and provide efficient guidance to the user / caregiver. Provides an easy and efficient way to notify.

[0257] While the principles of the invention have been described herein, this description is not intended to be limiting as to the scope of the invention. It will be understood by those skilled in the art that this is done by way of example only and not as a general guide. In addition to the exemplary embodiments shown and described, other embodiments are contemplated within the scope of the present invention. Modifications and substitutions by those skilled in the art are deemed to be within the scope of the present invention.

Claims

1. A medical remote controller device for controlling a medical device, comprising: the medical remote controller device includes a display on the medical remote controller device; the medical remote controller device receives input from at least one temperature sensor; If the at least one temperature sensor indicates a temperature change exceeding a predetermined threshold, the display displays a warning; The warning is dismissed for a preprogrammed time, after which the display will again show the warning; The medical device is configured to prompt a user to monitor blood glucose levels in response to the temperature changes.

2. A medical remote controller device as described in claim 1, wherein the display visually indicates the amount of bolus being delivered.

3. The medical remote controller device of claim 1, further comprising at least one input switch dedicated to bolus delivery, wherein bolus delivery is programmed when the input switch receives an input, and the number of inputs received by the input switch determines the amount of bolus delivered.

4. A medical remote controller device as described in claim 3, wherein each input received by the input switch indicates a pre-programmed amount of bolus to be delivered.

5. A medical remote controller device as described in claim 1, further comprising a glucose strip reader.

6. A medical remote controller device as described in claim 1, further comprising a jog wheel.

7. An infusion pump system, comprising: The infusion pump system comprises: at least one infusion pump including at least one temperature sensor; a companion device including a user interface and in wireless communication with the infusion pump; the companion device receives input from at least one temperature sensor; If the at least one temperature sensor indicates a temperature change exceeding a predetermined threshold, the user interface displays a warning; the warning is dismissed for a preprogrammed time, after which the user interface again displays the warning; The infusion pump system is configured to prompt a user to monitor blood glucose levels in response to the temperature changes.

8. The system described in claim 7, wherein the user interface is adapted to receive user input regarding insulin delivery volume.

9. The system described in claim 8, wherein the user input regarding insulin delivery volume is used to calculate the insulin being loaded.

10. The system described in claim 7, wherein the companion device further includes a glucose strip reader.

11. The system of claim 10, wherein test results from the glucose strip reader can be viewed using the user interface.

12. The system described in claim 11, wherein the test results can be viewed in line graph format using the user interface.

13. The system described in claim 11, wherein the test results that are most recent in time may be viewable on a home screen of the user interface.

14. An infusion pump system comprising: The infusion pump system comprises: at least one infusion pump including at least one temperature sensor; a companion device in wireless communication with the infusion pump; a first user interface on the companion device; a second user interface on the at least one infusion pump; the first user interface is substantially identical to the second user interface; the companion device receives input from the at least one temperature sensor; if the at least one temperature sensor indicates a temperature change exceeding a predetermined threshold, the first user interface and the second user interface display a warning; the warning is dismissed for a preprogrammed time, after which the first user interface and the second user interface again display the warning; The infusion pump system is configured to prompt a user to monitor blood glucose levels in response to the temperature changes.

15. The system described in claim 14, wherein the first user interface and the second user interface are adapted to receive user input regarding insulin delivery volume.

16. The system described in claim 15, wherein the user input regarding insulin delivery volume is used to calculate the insulin being loaded.

17. The system described in claim 14, wherein the companion device further includes a glucose strip reader.

18. The system of claim 17, wherein test results from the glucose strip reader can be viewed using the first user interface.

19. The system described in claim 18, wherein the test results can be viewed in line graph format using the first user interface.

20. The system described in claim 18, wherein the test results that are most recent in time may be viewable on a home screen of the second user interface.

Images