WO2023003698A1 - Insulin pump systems and methods of operating insulin pup systems - Google Patents

Abstract

An insulin pump system includes an insulin pump wearable by an associated user. The insulin pump is in fluid communication with a subcutaneous volume of the associated user and is configured to move a quantity of insulin into the subcutaneous volume. The insulin pump system also includes a controller in electronic communication with the insulin pump. The controller is configured to control operation of the insulin pump to meter the quantity of insulin moved to the subcutaneous volume. Additionally, the controller is configured to communicate with the user with at least one of Bluetooth, RF, or wireless communication.

Description

INSULIN PUMP SYSTEMS AND METHODS OF OPERATING INSULIN PUMP

SYSTEMS

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority to U.S. Provisional Patent Application No. 63/219,144, filed on July 7, 2021, entitled “INSULIN PUMP SYSTEMS AND METHODS OF OPERATING INSULIN PUMP SYSTEMS,” which is hereby incorporated by reference herein.

TECHNICAL FIELD

[0002] The present invention relates to an insulin pump system, and more particularly to an insulin pump system with a tubeless delivery of insulin from an insulin cartridge to a subcutaneous volume of an associated user.

BACKGROUND

[0003] There are known insulin pump systems for moving a quantity of insulin from an insulin cartridge to a subcutaneous volume of a user. Many insulin pump systems require tubing, for example, from an insulin reservoir or cartridge to a pump, or other locations. Other insulin pump systems are not indicated for users having accessibility issues including, but not limited to, vision impairments, lack of reading skill, or hearing impairments. Still other insulin pump systems do not include thermal control of insulin cartridges or reservoirs. Yet still other insulin pump systems do not include alternate controller enabled pumps. As such, improvements to insulin pump systems are desired.

SUMMARY

[0004] This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key factors or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter.

[0005] In accordance with an aspect, the present disclosure provides an insulin pump system including an insulin pump wearable by an associated user. The insulin pump is in fluid communication with a subcutaneous volume of the associated user. The insulin pump is configured to move a quantity of insulin into the subcutaneous volume. The insulin pump system also includes a controller in electronic communication with the insulin pump. The controller is configured to control operation of the insulin pump to meter the quantity of insulin moved to the subcutaneous volume. Additionally, the controller is configured to communicate with the user with at least one of bluetooth, radio frequency (RF), or wireless communication. [0006] In accordance with another aspect, the present disclosure provides an insulin pump system including an insulin pump wearable by an associated user. The insulin pump is in fluid communication with a subcutaneous volume of the associated user. The insulin pump system also includes an insulin cartridge in fluid communication with the insulin pump. The insulin pump is configured to move a quantity of insulin from the insulin cartridge into the subcutaneous volume. The insulin pump system further includes a thermal control unit configured to provide a thermally controlled environment around the insulin cartridge. The insulin pump system still further includes a controller in electronic communication with the insulin pump. The controller is configured to control operation of the insulin pump to meter the quantity of insulin moved from the insulin cartridge to the subcutaneous volume.

[0007] In accordance with another aspect, the present disclosure provides an insulin pump system comprising an insulin pump wearable by an associated user. The insulin pump is in fluid communication with a subcutaneous volume of the associated user. The insulin pump is configured to move a quantity of insulin into the subcutaneous volume. The insulin pump system also includes a remote control device including a controller in electronic communication with the insulin pump. The controller is configured to control operation of the insulin pump to meter the quantity of insulin moved to the subcutaneous volume. The remote control device includes text- to-speech software to enable provision of information to the associated user having at least one of a vision impairment or a reading impairment.

[0008] In accordance with another aspect, the present disclosure provides an insulin pump system including an insulin pump wearable by an associated user. The insulin pump is in fluid communication with a subcutaneous volume of the associated user. The insulin pump system also includes an infusion pad. The insulin pump system further includes an insulin cartridge attached directly to the insulin pump such that no tubing is required between the insulin cartridge and the infusion pad. The insulin pump system still further includes a controller in electronic communication with the insulin pump. The controller is configured to control operation of the insulin pump to meter the quantity of insulin moved from the insulin cartridge to the subcutaneous volume.

[0009] The following description and annexed drawings set forth certain illustrative aspects and implementations. These are indicative of but a few of the various ways in which one or more aspects can be employed. Other aspects, advantages, and/or novel features of the disclosure will become apparent from the following detailed description when considered in conjunction with the annexed drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0010] While the techniques presented herein may be embodied in alternative forms, the particular embodiments illustrated in the drawings are only a few examples that are supplemental of the description provided herein. These embodiments are not to be interpreted in a limiting manner, such as limiting the claims appended hereto.

[0011] Aspects of the present disclosure are best understood from the following detailed description when read with the accompanying figures. It is noted that, in accordance with the standard practice in the industry, various features are not drawn to scale. In fact, the dimensions of the various features may be arbitrarily increased or reduced for clarity of discussion.

[0012] FIG. 1 is an illustration of an example insulin pump and infusion pad located on an associated user;

[0013] FIG. 2 is an illustration of the insulin pump and infusion pad of FIG. 1 ;

[0014] FIG. 3 is a bottom view of the infusion pad of FIG. 1 ;

[0015] FIG. 4 is a perspective bottom view of the infusion pad of FIG. 1 ;

[0016] FIG. 5 is a perspective bottom view of the infusion pad of FIG. 1 showing a cannula and two meter probes extending away from the bottom of the infusion pad;

[0017] FIG. 6 is a perspective view of the insulin pump separated from the infusion pad;

[0018] FIG. 7A is a view of an example insulin cartridge;

[0019] FIG. 7B is similar to FIG. 7A showing a plunger attached to a piston;

[0020] FIG. 7C is a typical insulin supply bottle with a needle cap cooperating with the top of the insulin supply bottle;

[0021] FIG. 7D is similar to FIG. 7C showing the insulin cartridge separated from the needle cap;

[0022] FIG. 7E is similar to FIG. 7C showing the insulin cartridge cooperating with the needle cap;

[0023] FIG. 7F is similar to FIG. 7E showing the piston pulled downward to extract a volume of insulin from the insulin supply bottle;

[0024] FIG. 8 is a view of the insulin cartridge with the needle cap separated from the insulin pump;

[0025] FIG. 9 is a view of the insulin cartridge with the needle cap placed at least partially within the insulin pump;

[0026] FIG. 10 is a perspective view of the insulin pump separated from the infusion pad;

[0027] FIG. 11 is cross-section view of the insulin pump located partially within an aperture of the infusion pad; [0028] FIG. 12 is similar to FIG. 11 showing the insulin pump located entirely within the infusion pad;

[0029] FIG. 13 is similar to FIG. 4 illustrating an automatic line bleeding operation;

[0030] FIG. 14 is a perspective view of a controller;

[0031] FIG. 15 is a front view of the controller of FIG. 14;

[0032] FIG. 16 is a rear view of the controller of FIG. 14;

[0033] FIG. 17 is an illustration of an example screen on the display of the controller;

[0034] FIG. 18 is similar to FIG. 17;

[0035] FIG. 19 is similar to FIG. 17 showing a food intake input screen;

[0036] FIG. 20 is a top-down flow chart showing a method of operation of an example insulin pump system;

[0037] FIG. 21 is similar to FIG. 20;

[0038] FIG. 22 is similar to FIG. 20;

[0039] FIG. 23 is a schematic diagram of an example insulin pump system;

[0040] FIG. 24 is a schematic diagram of an exemplary computer-readable medium; and

[0041] FIG. 25 is a schematic diagram of an exemplary operating environment.

DETAILED DESCRIPTION

[0042] The claimed subject matter is now described with reference to the drawings, wherein like reference numerals are generally used to refer to like elements throughout. In the following description, for purposes of explanation, numerous specific details are set forth in order to provide an understanding of the claimed subject matter. It is evident, however, that the claimed subject matter can be practiced without these specific details. In other instances, structures and devices are illustrated in block diagram form in order to facilitate describing the claimed subject matter. Relative size, orientation, etc. of parts, components, etc. may differ from that which is illustrated while not falling outside of the scope of the claimed subject matter.

[0043] Certain terminology is used herein for convenience only and is not to be taken as a limitation on the disclosed subject matter. Relative language used herein is best understood with reference to the drawings, in which like numerals are used to identify like or similar items. Further, in the drawings, certain features may be shown in somewhat schematic form.

[0044] The following subject matter may be embodied in a variety of different forms, such as methods, devices, components, and/or systems. Accordingly, this subject matter is not intended to be construed as limited to any illustrative embodiments set forth herein as examples. Rather, the embodiments provided herein are meant to be merely illustrative examples of insulin pump systems, insulin pump accessories, and methods of using insulin pump systems in accordance with the present disclosure.

[0045] Insulin therapy medical devices and accessories are disclosed for people with diabetes (PWD) (sometimes referred to as diabetics) to maintain target glucose levels which are not common with many known apparatus and methods of syringe injections. For example, insulin pump systems are disclosed that may provide benefits to users having accessibility issues due to blindness, deafness, dyslexia, or diminished motor skill of their hands or arms. This list of accessibility issues is not meant to be limiting, but provides examples of various accessibility issues that can inhibit the ability of an associated user to effectively use and control many known insulin pump devices. In some examples, the various accessibility issues can lead to contraindication of many known insulin pump devices for the associated user. The system can be a fully integrated tubeless, wearable pump, controlled wirelessly through a handheld device. Some insulin pumps presently marketed are not accessible for users who may be blind, suffer from vision impairment, or have other accessibility issues. The disclosed apparatus, methods, accessories, etc. are intended to provide (to as many PWD as possible, or all PWD) an indicated insulin pump system that all insulin dependent diabetics (Type I and II) can use without assistance for control of glucose levels and the delivery of insulin to control glucose levels. [0046] It is to be appreciated that diabetes can cause deleterious effects to the human body such as vision impairments (including blindness), motor dysfunction issues such as neuropathy, etc. that can negatively affect PWD ability to treat diabetes. Also, PWD that also have arthritis, other various injuries, Parkinson’s disease, or ataxia, can also experience greater hardships while trying to maintain target glucose levels with known insulin pumps. Additionally, hearing loss is twice as common in PWD as it is in those who do not have diabetes, although a causal connection to diabetes may not yet be proven. Deaf PWD are more at risk of facing health inequalities to accessing care and are less likely to find accessible information to help better manage their diabetes.

[0047] The lessened ability of PWD to maneuver their hands due to many conditions listed here in combination with diabetes can be a significant group that can benefit from an accessible and ergonomic insulin pump.

[0048] Diabetes is a global epidemic, and blindness, deafness, dyslexia, illiteracy and disabilities of the hands, no matter the cause, are also an issue of concern. Combinations of any of these accessibility issues with diabetes leads to a desire for an accessible insulin pump system that is accessible to many more members of the PWD population than is presently the case. The

Insulin Pump system can be intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of Type I and type 0 diabetes mellitus in persons having been prescribed such by their treating physician.

[0049] In addition, the pump and insulin reservoir can have a thermally controlled environment in order to maintain insulin temperatures at or below a value of 85° F (29.4° C).

This can help prevent the insulin from breaking down due to high temperatures, resulting in more effective diabetes management. Currently, no insulin pump on the market today incorporates thermal management into its design. Insulation with temperature control. Can be a silicone layer with insulation. Firewall -similar. Blocks temp from batts and motor from plunger, and mainly the body. Added to the inside of the entire plastic shell of the pump. Thermal barrier or insulation.

[0050] The insulin pump system is configured to be user-friendly and an easy-to-leam device. Individuals that cannot comprehend printed material, as those with dyslexia, may find this insulin pump system accessible. The pump can enable those who are blind or vision impaired and/or deaf or hearing impaired to use the device independently. The disclosed insulin pump system and associated methods and accessories can be indicated for PWD having any combination of the various physical conditions previously discussed rather than contra-indicated for PWD having accessibility issues as with many presently available insulin pumps, e.g., for PWD who may be blind/vision impaired or deaf/hearing impaired, etc.

[0051] Referring now to FIG. 1, a portion of an example user 100 is shown with a wearable insulin pump 102 within an infusion pad 104. The user 100 is typically a PWD, and while the insulin pump 102 within an infusion pad 104 are shown on the torso of the user 100, it is to be understood that the insulin pump 102 and infusion pad 104 can be placed at various locations on the body of the user 100.

[0052] Meal and correction boluses are given as needed during the course of the day. For example, if the user has no appetite for breakfast, they can replace it with a small snack or nothing, checking periodically that their glucose level remains steady. Further, if the user wants to exercise at any given time, they can reduce or halt the basal delivery for a specified time, add food intake, reduce the bolus prior to exercise, or all three, as needed — all while checking their glucose level periodically.

[0053] The included controller can be a hand-held, rechargeable battery-powered remote for the insulin pump. It can have several functional buttons (up; down; left; right; enter; back; and sleep to put the screen to sleep and save battery life. Also, part of our design can be a back-lit liquid-crystal colored display and can read the information on the screen, with text to speech software, for users who may be blind, dyslexic or that may not be able to view the screen at any specific time. The controller can provide audio, visual and sensual alarms, alerts, and reminders related to insulin delivery, reservoir level, system function statistics, battery life, etc.

[0054] The pump can be activated and operated exclusively through use of the controller. The pump and controller can interact wirelessly using secure, bidirectional radio frequency. Wireless interaction can only be required to set a bolus delivery, change system settings, perform glucose measurements, or change the pump; in operation mode. During basal delivery, no wireless connection will be needed, so the controller will not need to be near the pump. The controller can give an alarm if any attention is needed.

[0055] The product can continuously monitor, regulate, and transfer insulin to diabetics based upon the personal needs of a particular user. The infusion pad and insulin cartridge may be replaced on an average of every two to three days. Infusion cannulas/needles that are part of the personal delivery system can be located under the skin so that the insulin is properly dispersed and absorbed as needed on a personal basis.

[0056] At least one of a hand-held controller (e.g., a remote control unit) or the insulin pump can have an ergonomic shape for those with issues with their hands/grip and a scroll wheel to more easily maneuver through the operating system, tactile buttons for those with sensory issues, text to speech technology for those who are either blind, vision impaired or dyslexic, and light and vibration alerts for users who may be deaf/hearing impaired. Considerations are also made for users with hand and/or arm motor issues in this ergonomic design.

[0057] The voice technology can help these users navigate and use the device per the personal instructions given. Text to speech tech reads the monitor and will say it out loud. Could be “low battery,” any communication to the user. Eliminates icon or image of graphs like 50% remaining insulin. Programming includes alt text and the text-to- speech in the programming. So, sighted people can see the graph, but visually impaired people can hear the meaning of the graph shown. Also, scroll wheel movement through menus, etc., then can read out loud the text displayed on the monitor of the controller. Volume, pitch, speed of speech can be altered for improved comprehension. Different timbre, etc.

[0058] This device can include one or more of ergonomic design, tactile buttons, voice technology, visible and/or sensory alarms/alerts and proprietary software that are configured to provide autonomy for those previously mentioned diabetics.

[0059] Referring to FIG. 1, the insulin pump 100 can be the insulin delivery device. It can be relatively small, relatively lightweight, and worn directly on the body. The adhesive on the base of the infusion pad can keep it securely in place for up to a 4-day life cycle. The controller and the pump can include vibration signal alerts, flashing lights for visual signals and beeps, buzzers and sirens to provide audio alarms, alerts, and reminders. [0060] The pump can be reused (e.g., it is reusable) and, if so desired, the insulin cartridge can be replaced when empty, along with the infusion pad while re-using the pump. The infusion pad and the insulin cartridge can be paired via micro-chips where both are configured to be replaced at the same time. If an infusion set fails for any reason, it may be possible to have Tech Support bypass any different codes when or if needed replaced before both are to be replaced together. This can be done via bluetooth or wi-fi connection. As previously noted, the reusable pump can lower total costs for the user versus many known insulin pump systems that require a new insulin pump with each new infusion pad, insulin cartridge, or other replacement medications, replacement parts, etc.

[0061] The controller can have the ability to protect information read to any user through bluetooth ear-phone connection. There can also be a 3.5 mm audio jack/port for those who will use with the ear-phones that can come with the system.

[0062] Referring to FIG. 12, insulin can be delivered through an integrated soft cannula in the infusion pad 200 that can be inserted automatically into the subcutaneous tissue. The cannula can be inserted with an automatic insertion command within the controller operating system. The pump can be intended for use with rapid-acting U-100 insulin: NovoLog® (Novo Nordisk A/S, Copenhagen, Denmark), NovoRapid® (Novo Nordisk A/S), Humalog® (Eli Lilly, Indianapolis, IA, USA), or Apidra® (Sanofi-Aventis, Paris, France). Just as the controller is in electrical communication with the insulin pump, the controller can be in electrical communication with the infusion pad. Additionally, the infusion pad can also be in electrical communication with the insulin pump such that the controller, the insulin pump, and the infusion pad are in electrical communication with each other and can transmit information between any combination of the controller, the insulin pump, and the infusion pad.

[0063] The infusion pad can use a standard, commercially available, medical-grade adhesive, designed for one-time use. Once removed, the infusion pad may not be able to be re-applied. [0064] The pump can be watertight at a depth of 25 feet for up to 60 minutes (IPX8). A pump housing can have pressure points, perhaps two, configured to be pressed simultaneously to disconnect the pump from the infusion pad or infusion site, where the cannula delivers the insulin. The pump can also include a vent to ensure pressure equilibration with the surrounding environment. The housing may not have any elements that allow user access to the pump mechanism or electronics other than user-serviceable parts as the insulin cartridge. The insulin pump system can also include filters to prevent issues involving radio frequency interference. The insulin pump system can also include proper security to reduce or eliminate potential hacking of the controller and other electronic portions of the insulin pump system. [0065] The motor mechanism of the pump can include a microprocessor control, shape memory alloy (SMA) wire assembly, a step sensor, and a motion sensor. The SMA wire assembly can be configured to rotate the driveshaft/lead screw, which is configured to advance the piston within the cartridge, and deliver the insulin through the cannula/infusion pad. In some examples, each actuation of the motor mechanism, the insulin cartridge can deliver about 0.05 units of insulin.

[0066] Cannula driven into skin (with needle inside) and then take out cannula. Needle is too small to break skin in some examples. When cartridge needs to be replaced [0067] Locking needle cap is on this new one. It goes through (punctures) a septum like on an insulin bottle, and then through the cannula into the body.

[0068] Adding braille marks on syringe-like device for pulling insulin out of vial from pharmacy. E.g., one dot for each 50 units of insulin.

[0069] Twist needle cap to lock and then motor cap will set to correct position to auto release 2 units of insulin to bleed air from system to eliminate chance of having air in system. Bled prior to application on user in auto-bleed mode. As soon as unlock needle cap (or motor cap) automatically unwinds motor at removal and automatically winds motor at insertion of new pump to bleed.

[0070] no tubing into cannula can reduce/eliminate chance of air injected into user.

[0071] Computer chip in cartridge has to be linked to the infusion set/otherwise will not operate together. Ten/month in past. One reason is to eliminate possibility -electronic handshake — of mold or bacteria growth within the cartridge.

[0072] The pump system is configured to incorporate an insulin cartridge that can contain up to about 300 deliverable units of U-100 insulin.

[0073] FIG. 7 Each insulin cartridge can be supplied with a fill syringe and a fill needle that are used to introduce insulin into the cartridge. The fill syringe can be properly sized to match the maximum fluid volume of the cartridge with a self-stopping plunger rod that limits the amount of insulin it can contain. The syringe can be clearly marked with the minimum fill volume (85 units) of the cartridge and also marked with units of insulin.

[0074] After the user fills the syringe with insulin, they are able to inject the insulin into the cartridge through a fill port. The fill port on the cartridge can have a self-sealing fill septum that can be designed for single-use only. This is to reduce or eliminate the possibility of injecting insulin into the port for a second use. Typical pump wear times can vary from 48 to 72 hours. The pump can have the capability of lasting up to 96 hours to allow for flexibility in changing the infusion pad and insulin cartridge due to unforeseen circumstances. [0075] When the user is ready to attach the infusion pad, they are able to remove the adhesive and cannula/needle and sensor covers from the proper side and place the Pad onto the prepared site. By following the controller’s screens or spoken directions, and pressing specific buttons, the user can instruct the infusion pad to activate its insertion mechanism, which is configured to quickly drive the insertion needle and the soft cannula as well as the glucose sensor and the ketone sensor into the subcutaneous tissue. The insertion needle can puncture the skin and stiffen the cannula during the insertion process. When it reaches its forward limit of travel, the insertion mechanism can retract and withdraw only the needle, leaving the cannula in place at the infusion site. The actual insertion can last only a portion of a second. The infusion pad can place the soft cannula into the user’s tissue at a 45-degree angle, to a depth of 6.5 mm - 9 mm.

[0076] An adhesive pad on the base of the infusion pad can hold the pump and the cannula in place. Added adhesive patches may be available with each infusion set to add extra holding power for those needing such.

[0077] Referring to FIG. 3, The controller 300 can handle various processes for the operation of the pump system. A display can use full text and speech synthesis to prompt the user through the set-up and use processes. The user can use the controller to program the pump using the user’s custom basal profile, check the pump status, initiate a bolus, or make changes to the insulin delivery profile. In some examples, the controller may need to be within 120 cm (approximately 4 feet) to communicate with the pump to perform these tasks. After set-up and initiation, the pump can ran at the programmed basal rate independent of the controller. If the controller requires the user’s attention, the controller, the pump and all individuals using the smart-phone application can give/receive an alarm, for example, an audio beep or siren, a heavy vibration, or a flashing light. [0078] The insulin pump system can incorporate its own continuous glucose monitor (CGM) and a ketone monitor. The insulin pump system can be configured to work with CGMs such as the Dexcom G6 and others marketed at the time of the pump system’s design or manufacture. The insulin pump system can be coordinated with multiple CGM providers to give the end user multiple CGM options.

[0079] The device can be configured to be paired with smart phones and tablets. Periodic software application updates can be made available for download by the user. The smart phones and tablets can assist, through various applications, with insulin information, procedures, personal care, and device maintenance. The controller can also include global positioning satellite (GPS) or other geo-location software or hardware such that the controller may be more easily located if misplaced, lost, or stolen.

[0080] Additionally, family and caregivers may be able to remotely monitor the diabetes patient through a sharing application to be downloaded into one’ s smartphone. [0081] Basic and simple to use, this application can allow the user’s glucose levels to be viewed by those sharing the application. Warnings or alerts for high or low levels can be received by all sharing the application, as well. There may be options for viewing events such as a bolus administered by the user of the pump. Doctors or caregivers may also use a remote monitoring application to help ensure the user/patient is properly maintaining desired glucose levels.

[0082] Remote alarms - be they audio; visual or touch sensitive, for low sugar levels can be especially helpful to ensure relatively fast action is taken.

[0083] The controller can include a glucometer (CGM) and Ketone monitor or can be synced with a CGM of choice. The glucose data can be stored and its history can be displayed on the controller or delivered to a smart phone through an application. For example, a user’s glucose variations can be seen in both graphical and list form for the past 1, 7, 14, 30, 60, and 90 days. The list form can show, for each time period, the average glucose reading, the minimum and maximum readings, the patient’s glucose goal range, the percentage of readings within, above, and below that goal, and the approximate 90-day AIC score. Along with insulin delivery records, this information can be valuable to the user’s physician or nurse when reviewing the user’s records. The considered CGM to the pump along with a ketone monitor can also be valuable for all for the monitoring of the patient’s or user’s critically important glucose readings or other statistics which may be vital to maintain the continued best health condition of the diabetic user. [0084] The Ketone monitor can include an insulin pump system configured to help prevent ketoacidosis from being realized. If ketone readings are high or higher than average, the diabetic user’s Physician can be informed through various methods.

[0085] The controller can be configured to calculate a suggested bolus dosage, which has traditionally been done manually by users of previously known pumps. The suggested bolus calculation feature can be provided as a convenience to the user to aid in determining the bolus dosage needed based on carbohydrates ingested, most recent glucose reading, user-settable correction factor, insulin-to-carbohydrate ratio, target glucose value, and duration of insulin action.

[0086] A carbohydrate counter program can be included for the proper dosage needed to be considered for bolus delivery such that a proper amount of insulin can be introduced to the user to account for the intake of meals and/or snacks.

[0087] The device can be regularly updated with software, apps, calculation methods, etc., in order to utilize future developments and can be customizable by the user. It’s expected that the pump system device hardware can last an average 4-5 years before needing to be replaced.

[0088] The “Accessible Insulin Device” technology can mimic some of the functions of a healthy pancreas by providing two options of insulin delivery, automatic or manual. [0089] The insulin pump system can be designed and manufactured to withstand most conditions during a user’s daily life activity. The pump system can be designed to meet or exceed IEC 60601-2-24 standards.

[0090] The insulin pump system device can have the option of an automatic mode that is to be a closed-loop/continuous-loop system that monitors glucose and automatically adjusts the delivery of basal insulin based on the user's glucose reading.

[0091] People with diabetes (e.g., the user) can use the glucose information from the controller or through the application downloaded to a phone/tablet/smart device to help determine patterns in the user’s glucose levels.

[0092] In some examples, the insulin pump system can alert users when glucose values are approaching potentially dangerously high (hyperglycemic) and/or dangerously low (hypoglycemic) levels.

[0093] The insulin pump system can also help people with diabetes (e.g., the user) make long term adjustments to the user’s treatment plan to keep glucose levels within a safe range.

[0094] The insulin pump system will have its own glucometer and can be configured to work with or to be synced with other continuous glucose monitors (CGMs) that can measure the user's glucose levels for a specific amount of time. Those others, on the market, range from 10-days to 2-weeks. The CGM to be part of the infusion pad can be replaced each time the infusion pad and insulin cartridge are replaced since it and the ketone monitor are planned to be part of the described infusion pad.

[0095] The insulin pump can automatically adjust the delivery of insulin using a mathematical equation, or algorithm that incorporates information from the CGM, as well as factors defined by the pump user when automatic mode.

[0096] The insulin pump system can have two modes; Manual Mode and Automatic Mode. While in Manual Mode, the system can be programmed by the user to deliver basal insulin at a preprogrammed constant rate. While in Automatic mode, the system can automatically suspend delivery of insulin if the sensor glucose value falls below or is predicted to fall below a predetermined threshold. This threshold is a setting of which the user and his/her treating physician have defined to be a glucose level that would be determined to be low enough for concern or alarm where continued automatic basil insulin dosage would only cause the user’s glucose level to continue to fall. The system can also automatically resume delivery of insulin once sensor glucose values rise above or are predicted to rise above a predetermined threshold. To summarize, while in Automatic Mode, the system can automatically adjust basal insulin by continuously delivering or suspending delivery of insulin based on CGM values (different from Manual Mode where basal insulin can be delivered at a constant rate). Although Automatic Mode can automatically adjust basal insulin delivery without input from the user, the user can still manually deliver insulin boluses during meals.

[0097] SYSTEM COMPONENTS:

• Insulin Pump and charger

• Insulin cartridge

• Infusion pad

• Controller w/ charger

[0098] FUNCTIONALITY:

• maintain sugar levels in your target range — day and night.

• Stops insulin up to 30 minutes before reaching preset low limits.

• Automatically restarts insulin when levels recover without bothersome alerts.

• Helps avoid lows and rebound highs.

[0099] CHARACTERISTICS AND CAPABILITIES:

• Pod type pump

• Ergonomic design

• Includes easy-install insulin cartridge

• No tubing

• Onboard electronics

• Visual, Audible and vibration alerts

• Self-priming

[00100] CGM SYSTEMS:

• The infusion pad can have its own glucometer or can be capable of syncing with several CGM devices

• Send alerts to multiple followers sharing the information through smart phones or tablets.

• Small and flat design

[00101] The insulin pump system can include an alternate controller enabled (ACE) infusion pump. In other words, the pump can be operated using a remote control device and work with its own glucometer and ketone meter as well as CGMs made by others, such as a Dexcom G6, for example.

[00102] The insulin pump can be configured to be used as a component of an invasive glucose device. The pump can be designed to pump fluid (insulin) into a patient in a controlled manner as an aid in the management of diabetes mellitus in persons requiring insulin. The insulin pump system can be configured to accept and display data from the glucose sensor. [00103] The pump can be designed to pump fluid (insulin) into the user (e.g., a patient) in a controlled manner as an aid in the management of diabetes mellitus in persons requiring insulin. It is intended to accept and display data from the glucose sensor.

[00104] Insulin can be delivered subcutaneously to a user in both levels of too much or too little. Too much can cause hypoglycemia or low blood sugar which can and can cause death at extreme low levels. Too little insulin can result in hyperglycemia or high blood sugar levels that cause damage to the user’s body. The user’s circulation, eyes, kidneys, and heart can be damaged, including potential organ failure as a result of said hyperglycemia.

[00105] Common risks when using an insulin pump can be avoided using the described insulin pump system. For example, infections at the infusion site are common with previous devices due to not cleaning the area before and after the infusion set is placed or removed. Low battery and low or no insulin supply can cause the pump to not work properly or not at all and/or the user to face consequences previously mentioned due to hyperglycemia. If a user has vision or hearing disabilities and cannot hear or read alerts/wamings given by the insulin pump, negative effects to the user can and do occur unnecessarily. The presently described Insulin Pump system can include needed technologies so that those blind/vision impaired or deaf/hearing impaired will be indicated and will be able to receive and acknowledge said alerts and/or warnings received from the insulin pump system.

[00106] Rewards of proper use of the insulin pump are a lifestyle where the user has freedom around their therapy for activities and work.

[00107] CSII delivery, in general, allows for greater flexibility in insulin delivery options leading to more lifestyle choices related to meal planning and exercise. More specifically, the described insulin pump system can contribute to improved diabetes management for a variety of reasons, including:

• Technologies embedded for those needing added accessibility technology

• Those previously contra-indicated can now be indicated

• Able to be used by those blind/vision impaired, deaf/hearing impaired, dyslexic and those having motor skills issues with their hands due to nerve damage, arthritis, injury etc.

• equal insulin therapy options where users can use the pump system safely and independently.

• ease of training

• setup and insertion

• uninterrupted and untethered insulin delivery

• Independent glucose monitor (CGM) and Ketone meter

• Matched to the user’s CGM of choice [00108] An additional advantage of the described insulin pump system may be that the pump, once on the body, will not move. This will result in less fluctuation in hydrostatic pressures, ideally leading to more consistent insulin delivery.

[00109] Having an insulin pump with a CGM allows PWD the ability to manage their insulin intake and sugar levels openly without most others knowing.

[00110] INDICATION VS. CONTRA-INDICATION:

[00111] It is obvious for the need to have users of medical devices to be able to use the product safely and independently. It could also be understood that those who are blind could not follow information given by a medical device as an insulin pump which has those blind/vision impaired being contra-indicated. The same for those deaf/hearing impaired, where they are contra-indicated due to not being able to hear alerts or warnings given by the said insulin pump. However, text to speech technology can benefit those having reading impairments such as dyslexia or vision impairments such as blindness. Additionally, the ability to imbed vibration technology and/or flashing light alerts for those deaf/hearing impaired creates the possibility for these groups to be indicated and not contra-indicated.

[00112] For many individuals with diabetes, the use of an insulin pump is the only way to reach acceptable glucose control levels. The described Insulin Pump System can improve on the traditional method of delivering insulin via syringe injections for the following reasons:

• It can free up individuals with diabetes of being tethered to their pumps via a tube.

• It can provide consistent, round-the-clock, uninterrupted insulin delivery.

• It can allow for easier set up and automated cannula insertion.

• Greater ease of use can lead to a greater level of compliance.

[00113] The described Insulin Pump System can offer the comfort and safety of feedback and alarms, the ability to follow daily, monthly, and quarterly progress, and the feeling of accomplishment in managing one’s own diabetes for those previously not being able to independently and safely use a pump for the control of their diabetes through insulin pump therapy.

[00114] Additionally, users do not need to be “technologically savvy,” because the device’s user interface can be configured to be very clear, straight forward and simple. Almost all individuals with type I and type II diabetes can benefit from using the described Insulin Pump System.

[00115] The described platform may lend itself to many other uses. For example: As a delivery mechanism for infertility drugs, pain management, chemo-therapeutic agents, AIDS, Parkinson’s, and multiple sclerosis drugs, biologies, thyroid, growth hormones, and related peptides, as well as in-hospital uses for those from the very young to the elderly. [00116] The described insulin pump system is indicated for those who may be blind or vision impaired, deaf or hearing impaired, dyslexic, and/or those having motor issues with their hands as well as indicated for others without these impairments.

[00117] This pump system is utilizing technologies as text to speech software, adequate ergonomics and tactile designs, audible; vibration and flashing lights, mobile data sharing, and a user-friendly operating system This delivery system is to be for people as young as five years old. System settings and controls can be configured to be locked and with embedded filters, we have insured security of this system and the data within.

[00118] The pump and infusion pad can be tubeless and the pump is to be reused with only the infusion pad and the insulin cartridge being replaced as necessary. With bluetooth sync capabilities, the text to speech can have the ability to remain private without others hearing the information spoken. For those deaf or hearing impaired, the alerts and/or notifications are configured to be able to be recognized, such as through vibration or other alerts. This system can use rechargeable battery power supply technology with a magnetic charging cable. The automatic insertion of the cannula helps assure introduction of insulin is properly accomplished. This system can include the option of a closed loop algorithm to allow for the best control of the user’s glucose levels. A glucose sensor and a ketone sensor can be part of the infusion pad. These sensors talk to a transmitter that sends the information wirelessly (e.g., via wi-fi) to the controller where the status or levels of glucose levels, ketone levels, etc. are able to be monitored.

[00119] In some examples, the needle cap transfers the insulin from the pump insulin cartridge, through the infusion pad, and exiting the cannula into the user’s soft tissue/subcutaneous tissue. The insulin cartridge is inserted inside the insulin pump. In some examples, tubing is not needed between the insulin cartridge, within the insulin pump, to pass the insulin to the infusion pad and therefore injected into the user. In these examples, the insulin pump connects directly to the infusion pad. The insulin pump is reusable while the insulin cartridge, the needle locking cap and the infusion pad are one-time-use. The infusion pad contains the cannula through which the insulin travels and then on into the soft tissue of the user.

[00120] The needle cap locks the insulin cartridge into the insulin pump. The plunger motor within the pump pushes insulin out from the insulin cartridge, exiting the needle cap. The needle cap is connected to the infusion pad through the needle cap and the needle cap penetrates a septum. The septum is similar to known tops of insulin bottles and prevents back flow of the medicine where it proceeds through the infusion pad and exits through the cannula into the user. Nothing or no insulin pump uses such and no system on the market has the reuseable pump directly connected to the infusion pad where the pump is reused and the infusion pad, is synced to the insulin cartridge via micro-chip technology. [00121] Some potential example benefits/definitions:

• The insulin pump system automatic mode can automatically adjust insulin delivery based on the user’s sensor glucose values.

• Work closely with the user’ s healthcare professional when starting insulin pump therapy.

• the term Automatic mode refers to the automatic control of insulin delivery.

• When the pump is not operating in Automatic mode, the pump is in manual mode.

• In some examples, the pump can be reusable and does not need to be changed with every insulin cartridge and/or infusion pad. The reusable pump can reduce the annual cost for the user and can help maintain the insulin administration costs below a set insurance co-pay amount or maintain the insulin administration costs closer to a set insurance co pay amount.

[00122] Indications:

[00123] The insulin pump system is intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of Type 1 and Type 2 diabetes mellitus in persons with diabetes (PWD), requiring insulin as well as for the continuous monitoring and trending of a glucose level and a ketone level in the fluid under the skin.

[00124] This system has been designed and is indicated for those blind or vision impaired, deaf or hearing impaired, dyslexic, and those with motor issues with their hands.

[00125] The insulin pump system includes a closed loop algorithm automatic mode, which can be programmed to automatically adjust delivery of basal insulin based on Continuous Glucose Monitor sensor glucose values, and can suspend delivery of insulin when the sensor glucose value falls below predefined threshold values.

[00126] In some examples, the insulin pump system can include the following components:

1. The Accessible controller

2. ear plugs/buds

3. ZEUS XS1 Insulin Pump

4. insulin cartridges

5. infusion pads (over-lay patch per infusion pad)

6. Magnetic charging cable

[00127] While in automatic mode, the closed loop algorithms of the insulin pump system can automatically increase or decrease insulin delivery when informed by continuous glucose monitoring (CGM) values within pre-set setting thresholds; however, the user may benefit from calculating and administering meal boluses. [00128] As previously mentioned, the insulin pump system can feature a close-loop technology with different types of diabetes management. There are two levels of close-loop technology: [00129] The first level of close-loop technology can automatically suspend insulin when the sensor reaches a preset low limit, referred to as suspend on low. This is an option while in manual mode.

[00130] While in automatic mode, the Suspend on low feature can be automatic and, if automatic, needs no input from the user. While in manual mode, optional features are available. [00131] The second level of close-loop technology can automatically calculate insulin dose using CGM data, referred to as Automatic Mode. The Automatic Mode feature can automatically increase or decrease the amount of insulin delivered based on pre-set thresholds or ratios set within the controller operating system. Elevated sensor glucose readings result in increased delivery rates and decreased sensor glucose values result in decreased or suspended insulin delivery rates. “Suspend on low” is a feature in both manual and automatic modes.

[00132] During Automatic mode operation, the user may benefit from delivering meal boluses by entering a predetermined amount by the treating Physician or by using the Carb Counter, within the operating system menu, totaling the amount of carbohydrates for foods chosen at the time the specific meal is eaten.

[00133] Since adjustments to insulin delivery rates, when the system is in Automatic Mode, are based on sensor glucose readings, it may be beneficial to monitor blood glucose values using a home glucose meter regardless of whether the system is operating in the Manual Mode or the Auto Mode.

[00134] Transmitter and sensors are within the infusion pad and connect to your controller. The transmitter collects data measured by the sensor and wirelessly sends this data to the said controller.

[00135] Controller features:

[00136] Referring to FIG. 4, as you hold your controller 300, the ergonomic shape allows the controller to be held with either hand, equally. With the monitor at the top of the screen, the following features can be found.

1. The monitor - (top of the controller)

2. indicator light - (above the monitor, center of monitor screen)

3. back button - (just below the bottom left comer of the monitor)

4. sleep button - Just below the bottom right comer of the monitor)

5. Arrow Keys - tactile and all arrows indicating the direction the cursor will move if pressed)

5 a. up arrow - (moves cursor upward) 5b. left arrow - (Moves cursor to the left)

5c. Right arrow - (Moves the cursor to the right)

5d. Down Arrow - (Moves the cursor down or downward)

6. OK or Confirm button - (Center of arrow keys. To OK or Confirm an action or setting. A tactile circle with a braille dot within the center)

7. Scroll ball: Below the down arrow key, to scroll through information upon the screen)

8. ear plug port - (3.5Mm port on upper edge or side, above the monitor’s left side)

9. speaker: - (Upper edge or side above the monitor’s right side)

10. Belt clip track - On back or under side of controller. Belt clip attaches here)

11. Magnetic Charge base - Located on the bottom side of the controller. The side nearest the scroll wheel. To recharge the controller’s battery. No port, just connect the end of the charging cable to this metal base and will automatically attach/connect and begin to charge)

[00137] To use the Startup program:

1. The Startup program begins after the Welcome screen appears. When the Language screen appears, select desired language to be read on screen and spoken by text to speech software.

2. When the Select Time Format screen appears, select a 12 hour or a 24 hour time format.

3. When the Enter Time screen appears, adjust the setting to the current time. If you are using a 12-hour clock, be sure to specify AM or PM. Select Next.

4. When the Enter Date screen appears, adjust the Year, Month and Day to the current date.

5. Select Next.

• A message confirms that your initial setup is complete, and then the Home screen appears.

• After you enter your initial settings, see the following sections in this chapter to become familiar with the buttons and screens on your controller.

[00138] Unlocking your controller:

[00139] Your controller automatically locks when entering sleep mode. When you wake up your controller from sleep mode, you must unlock your controller before navigating away from the Home screen. When you press select , you will be shown a screen asking you to unlock your controller. Press the highlighted button or you will hear which button to press to unlock your controller, if using the text to speech feature. • The controller will take you to your selected screen after you press the correct button. If you press an incorrect button, the following screen appears and you will need to select OK to return to your Home screen and try again.

• If you press the button, you will be taken back to the Home screen.

[00140] Status icons:

[00141] The status icons appear on the Home screen to provide a way for you to quickly check the status of your system and your currently monitored levels as your:

1. Your current AIC

2. your glucose levels

3. your ketone levels.

• Your controller is designed to conserve battery power when you are not actively using your systems screen. Your controllers screen is on. Unless you are actively using another screen, your home screen appears.

• To wake up your pump from being in sleep mode, press any button.

• If your controller has been in sleep mode, the screen is locked. To unlock your controller and system, you will need to follow the directions to which keys to push to unlock. If using the text to speech feature, the key or keys/buttons to press will be read aloud.

• the operating system returns to the screen that was last displayed.

[00142] Referring to FIG. 5, the pump is re-used. In most examples, the needle cap and the insulin cartridge are one-time-use items, while the pump is used again (e.g., reusable) with subsequent insulin cartridges and needle caps.

[00143] The pump is the delivery system of the insulin and is both water-proof and has accessibility features so those whom cannot hear or hear well will have a flashing (LED) light and vibration to be notified of an alert or notification.

[00144] Referring to FIG. 6, the pump 100 can connect to the infusion pad 200, gliding through a track that allows the needle cap and power connector to line up without effort.

[00145] The needle cap is what holds the insulin cartridge within the pump chamber. Both the needle cap and the cartridge are one-time-use components. In some examples, the insulin cartridge held within the pump chamber will hold up to about 300 units of insulin.

[00146] In some examples, the cartridge chamber, as shown in FIG. 11 within the insulin pump, is climate controlled. This is to keep the insulin within the cartridge below about 85 degrees F (about 29.4 degrees C). This is can be beneficial because insulin begins to break down at about room- temperature or about 85 degrees F. The body’s normal temperature is about 98.6 degrees F or about 37 degrees C. [00147] The pump powers all components within both the pump and the infusion pad. The batteries are rechargeable using a magnetic charging cable.

[00148] Disconnecting the pump from the infusion pad:

[00149] You may have an occasion where you may need or want to disconnect or detach your pump from the infusion pad. If you have to remove or store your pump, it is recommended that you do the following.

[00150] Write down a record of your current basal rates and use the Save Settings feature within the settings utilities tab.

[00151] Remember, your body still needs insulin while your pump is removed. Consult your healthcare professional to determine an alternate method of receiving insulin. Disconnecting from your pump for less than one hour may not require an insulin adjustment. If you remove your pump for more than one hour, you should take your insulin another way, as prescribed by your healthcare professional.

[00152] Basal settings:

[00153] Basal block: Determines the amount of insulin you receive per hour throughout the day and night. Allows you to vary your basal rate according to your needs. You can set up to eight basal blocks. A block is a period of time scheduled to have specific amounts of insulin delivered during this time.

[00154] A basal rate that you use in place of your current basal rate for a duration of time that you specify. A temporary basal rate Allows you to set and save temporary defined basal rates for known short-term situations, such as when you are sick or have times of increased or decreased activity.

[00155] The maximum amount of basal insulin your pump can deliver per hour provides a safety measure by limiting the total amount of basal insulin your pump can deliver per hour. If you are setting your max basal rate after you have set up your basal blocks or preset temp basal rates, you cannot set your max basal rate lower than any of your existing basal rates. You cannot access this feature during a normal bolus delivery.

[00156] Max Basal Rate limits the amount of basal insulin that can be delivered per hour, based on the maximum rate you set. You are unable to set any basal rates, temp basal rates, or preset temp basal rates that exceed the max basal rate amount. You can set your Max Basal Rate from 0 to 35 units per hour. Set your max basal rate as prescribed by your healthcare professional. [00157] On the Max Basal Rate screen, select the maximum number of units for your maximum

Basal rate per hour. You can choose from about 0.1 to about 35 units per hour. Select or press the ok button to confirm. [00158] Regarding basal blocks, the user’s basal block determines the amount of basal insulin you receive throughout the day and night. Because your basal insulin needs can vary, you can set up to eight basal blocks. For example, you might use one basal block during the hours of midnight to 6:00 AM and a different basal block during the hours between 6:00 A.M. and 6:00 P.M. and 6:00 P.M. to midnight.

[00159] A basal block is made up of one to 48 basal rates that you set up to cover a full 24- hour period. If you only need one basal rate throughout the day, you set only one block from the 24-hour period. If you need the basal rates to change during the day or night to better match your insulin needs, you can set more than one block each with a separate start and end time. Your healthcare professional will determine what rates are right for you.

[00160] Temporary basal rates:

[00161] The Temporary Basal feature allows you to set temporary basal rates to manage blood glucose levels during short-term activities or conditions that require a basal rate different than your current one, such as an illness or a change in physical activity. You can make an immediate change to your basal insulin for a set period of time (30 minutes to 24 hours), up to your max basal rate.

[00162] Automatic Mode is not available if the Temporary Basal feature is active. If you wish to switch your pump to Automatic Mode, you must first cancel the Temporary Basal mode. [00163] About Temporary Basal rates:

[00164] A temporary basal rate overrides all other basal programming settings while active. Your programmed basal pattern resumes after the temporary basal rate delivery is completed or cancelled.

[00165] The Temporary Basal feature allows you to set and start a temporary basal rate immediately. The Preset Temporary feature allows you to set up a temporary basal rate ahead of time for known situations. You define temporary basal rates and preset temporary basal rates using either a percentage of your current basal pattern, or by setting a specific rate.

[00166] Temporary basal rates can be set to deliver no more than twice the amount of your scheduled basal rate. The amount you can use, however, is based on the largest basal rate scheduled during the temporary basal duration, and is limited by your max basal rate.

[00167] Starting a Temporary Basal rate:

[00168] When you start a temporary basal rate, your basal delivery changes to the temporary basal rate for the duration you set. When the duration is complete, your basal insulin automatically returns to the active basal block scheduled.

[00169] To start a temporary basal rate:

• Go to the delivery tab within the settings. Go into Basal. • The time duration is presented. Set the Duration for this temporary basal rate. The Duration can be set from 30 minutes to 24 hours, in 15-minute increments.

• Select Next.

• Enter a basal rate, making sure you do not exceed your max basal rate.

• Press next to continue

• You will have a time block to schedule this temporary basal rate. You can set in 15- minute increments. Your Temp Basal rate continues for the duration you set.

• A Temporary Basal icon appears on the Home screen during your temporary basal delivery.

• Your scheduled basal rate automatically starts again when your Temporary Basal rate concludes.

[00170] In order to switch to Automatic Mode, you must first cancel any active Temporary Basal rate. Automatic Mode cannot begin while a Temporary Basal rate is active.

[00171] A bolus is the amount of insulin taken to cover an expected rise in blood glucose (BG), typically when you eat a meal or snack. You can also use a bolus to correct a high blood glucose reading.

[00172] About bolus deliveries:

[00173] There are different types of bolus deliveries you can use, depending on your insulin needs at the time. There are also different ways you can deliver a bolus. Discuss these options with your healthcare professional to determine what is best for you.

[00174] Bolus types:

• When you are in Automatic mode, you can only deliver a Normal bolus if the automatic mode is not currently bolusing due to high glucose levels.

[00175] Bolus delivery options:

• Within the delivery settings you can choose which way you are to receive a bolus insulin amount as needed.

• Quick bolus: From history records of frequently delivered bolus amounts, these options are able to be selected. Up to 5 quick bolus amounts are displayed and the amount of a bolus to be delivered is dependent on the maximum bolus rate set.

• A bolus for meals is dependent of the user during both manual mode and automatic mode. An added bolus for high glucose levels cannot be delivered if in automatic mode since this mode automatically delivers correction boluses with the settings thresholds stored.

• Normal bolus: A normal bolus for a meal can be delivered utilizing the bolus delivery options within the settings > delivery > bolus page. This can be used in manual mode but not in automatic mode. • Carb counter: When using the carb counter and having the insulin ratio set, you can receive a meal bolus utilizing this feature.

[00176] Maximum bolus: The Maximum Bolus amount: Maximum amount of bolus insulin (in units) your pump can deliver in a single bolus delivery.

[00177] Bolus Increment: The amount of insulin (in units) that is increased or decreased with each button pressed when adjusting your bolus amount with a normal bolus delivery. The amount that can be increased or decreased is 0.1 / unit increments.

• This setting does not apply when using a quick Bolus delivery.

• Your pump prevents single bolus insulin deliveries that exceed the max bolus you set.

• You can set your max bolus from 0.1 to 25 units. Set your max bolus as prescribed by your healthcare professional.

• The max bolus setting applies to both Manual Mode and Auto Mode.

[00178] Active insulin is the bolus insulin that has already been delivered to your body, and is still being absorbed and working to lower your blood glucose levels. The system considers the time of your last bolus in determining if any active insulin is still in your body. This may help prevent hypoglycemia caused by over-correcting for high blood glucose. Your current active insulin amount displays on the home screen, and includes only the bolus insulin you have already received. It commonly takes 1-hour for active insulin to begin reducing glucose levels the active insulin may take up to 4-hours to fully absorb.

[00179] Stopping a bolus:

• If a bolus has been confirmed for delivery, you have only a few very brief moments to stop the bolus from being delivered.

• Go to settings > delivery > bolus > stop delivery.

• Click the stop bolus and confirm you want to stop the current bolus.

• The Bolus Stopped screen will appear and show the amount of bolus delivered.

• the original bolus amount you set up is also shown.

• The remaining insulin not delivered is not able to be continued for delivery. You must start a new bolus if needed and as important, as long as you are not within your max bolus amount set.

[00180] Insulin flow blocked:

• If the flow of insulin being delivered has been blocked for any reason, you will receive an alert.

• Check to be sure the needle cap on the pump is properly through the septum barrier of the infusion pad.

• Be sure the needle cap is secured properly. • Be sure the cannula has not retracted from within your soft tissue and is not bent.

• If flow cannot begin again, you will have to replace the infusion pad.

• You will follow the steps within the infusion pad placement section of this guide to replace the infusion pad.

• Contact Tech Support to have the infusion pad synced with the in-use insulin cartridge. [00181] Removing the insulin cartridge:

• If this is the first time you are inserting a cartridge into your pump and you do not currently have an insulin cartridge loaded, skip this section regarding removal of the insulin cartridge.

[00182] When the old cartridge is removed, the pump will rewind automatically. The piston in the cartridge compartment will return to its starting position and allow a new cartridge to be placed into the pump. This will take a few seconds to complete. The piston is located in the cartridge compartment of your pump. It engages the insulin cartridge and pushes insulin from the cartridge, through the infusion pad and into the user.

[00183] During the rewind phase, a message will appear on the screen of the controller that indicates this event is in progress. Upon finishing, another message appears to let you know that your pump has finished rewinding.

[00184] Referring to FIG. 7, to fill the insulin cartridge, follow these steps:

1. Remove the new insulin cartridge, needle cap, infusion pad, and filling components from the package.

2. Fully extend the plunger. This is attached to the bottom of the insulin cartridge.

3. Swab the top of your insulin vial with an alcohol wipe.

4. Press the transfer guard onto the top of the vial without pushing down on the plunger. The plunger rod is on the top.

5. Push down the plunger rod to put air into the vial, to pressurize the vial.

6. Continue holding down the plunger rod.

7. Turn the vial over, the vial is now on top and upside down slowly pull the plunger rod down to fill the cartridge.

8. Gently tap the side of the cartridge to make any and all air bubbles rise to the top of the said cartridge.

9. Slowly push up on the plunger rod just enough to remove any air bubbles from the insulin cartridge.

10. Again, if needed, pull on the plunger rod to fill the cartridge to your desired amount. For those using the tactile markers, each braille dot is 75-units. If you have the plunger rod fully extended, you will feel and count 4 total braille dots for a total of 300 units now within the cartridge.

11. Flip the vial over so it is upright. This will prevent any liquid from getting onto the top of the cartridge.

12. Turn the cartridge counter-clockwise, then pull straight up to remove the insulin cartridge from the transfer guard.

13. Place the needle cap connector end onto the insulin cartridge. Turn the connector clockwise, pressing gently against the cartridge until you feel it slide in. Push in and continue turning until the cartridge and the connector lock with a click. Do not remove the needle protective guard at this time.

14. Tap the side of the cartridge, again, to allow any air bubbles to rise.

15. Again, if needed, to purge air bubbles that have risen to the top of the insulin cartridge, push up on the plunger just enough until insulin is seen exiting the needle cap connector.

16. Without pulling, turn the plunger counter-clockwise to remove it from the bottom of the insulin cartridge.

[00185] Referring to FIG. 8, if you are using the pump for the first time, remove the shipping cap from the cartridge compartment within the pump.

1. Insert the insulin cartridge into the top of the cartridge compartment.

2. Turn the needle cap connector approximately a half-turn clockwise until the connector is locked. The needle cap connector should be aligned horizontally with the pump case.

3. The automatic loading process will begin without any further action. This will take a few seconds and a few drops of insulin will be forced out through the end of the needle cap.

[00186] After the automatic loading process begins, a Loading alarm will occur to focus you to do nothing until this alarm stops.

[00187] When the loading alarm concludes, you can now connect the pump to the infusion pad. Be sure the needle cap protective guard has now been removed. The power supply connector is also aligned automatically and should line up without added effort.

[00188] You must have completed the procedures, as described previously, before inserting the infusion pad into your body.

[00189] After your infusion pad and pump are connected together, follow these steps to have the infusion pad properly set in place:

1. find an appropriate infusion pad location and clean well with alcohol.

2. remove the cannula and sensor guards from the bottom of the infusion pad. 3. remove the adhesive cover strip and set the infusion pad into place onto your body location chosen.

4. Press down firmly onto the infusion pad to assure a good adhesion is had.

5. If using the included overlay patch for extra holding, place this now.

6. Within your controller settings, go to utilities and enter into automatic insertion.

7. click the insert now button.

8. Hit the ok button in the center of the arrow keys to confirm you want this to proceed.

9. The cannula and both the ketone and glucose sensors have now been inserted.

10. From the same screen, click on begin delivery. Your basil rate set will begin immediately.

11. The ketone and glucose sensors will begin presenting readings on the home page after the warm-up stage concludes. You will see the time remaining with the warm-up phase, 2-hours, on the home page, during this event.

1. Referring to FIG. 9, while pressing down on the top of the pump, slide it back away from the infusion pad septum. The pump will slide down the track and is now disconnected.

[00190] Why the cartridge and infusion pad are synced and what does this mean:

[00191] Computer chips in both the infusion pad and the insulin cartridge sync the pair together. This prevents either of the infusion pad or the insulin cartridge from being used a second time, which can be a common practice. The two components are matched.

[00192] This assures the user will remove the infusion pad and find a new location for an infusion pad placed on the user after removal of the previous infusion pad. Moving the infusion pad to new locations can be beneficial to reducing or preventing infections. In some examples, prevention of re-use of at least one of the infusion pad or the insulin cartridge can reduce or eliminate bacteria formation within at least one of the insulin cartridge or the infusion pad. [00193] In some examples, the insulin pump system can include a_hi story feature includes the Summary, Daily History, and Alarm History screens.

[00194] You can view historical details for a single day, or you can select multiple days to view an average of all the results for the number of days that you selected.

[00195] In some examples, only the past 90-days are held within the history.

[00196] Summary screen:

[00197] The Summary screen shows details about past insulin deliveries and meter readings. If you are using a sensor, the Summary screen also shows information about your sensor alerts and sensor glucose readings.

[00198] Daily history: [00199] The Daily History screen displays a list of actions you performed or event entries that you made for the selected day, such as your glucose readings, glucose and/or ketone sensor calibrations, bolus deliveries, any temporary basal rates you have used etc. The list displays the most recent action or event first. From this list, you can display further details about any action or event.

[00200] To view your daily history:

1. Go to: settings > History > Daily History tab. A list of dates appears.

2. Select a specific date of history to view. A list appears only with any pump actions or events entered on the specified day.

3. You can select any item in the list to open the Detail screen, which displays more information about the selected action or event. For example, if you view the details of a bolus delivered, the Detail screen shows you all of the data associated with that bolus, such as the BG amount at the time of the bolus or carbs entered for a meal.

[00201] Reviewing ketone and/or glucose history:

[00202] Reviewing the Glucose and/or ketone history feature allows you to view a graph or have the full text option of your glucose and/or ketone history, based on sensor readings. You can view information for one day, or view an average of your data over a selected number of days. [00203] To review your sensor history:

1. Go to the settings > History tab.

2. Go to either: History > glucose history or History > ketone history.

3. The selected Review screen appears. The high or low values that appear are the values for the last sensor reading.

[00204] Alarm history:

[00205] The Alarm History screen displays a list of alarms and alerts that occurred on the selected day. The list displays the most recent alarm or alert first. From this list, you can display further details about any alarm or alert.

[00206] To view your alarm history:

1. Within settings > History

2.Go to the Alarm History tab and hit enter.

3.A list of dates appears.

4. Select a specific date of alarm history to view. A list appears showing any alarms or alerts that occurred on the specified day.

5. You can select any alarm or alert in the list to open the Alarm Detail screen, which displays more information about the selected alarm or alert.

[00207] Text to speech settings: [00208] The controller is equipped with accessibility technology so those presently contra indicated, can use this system safely and independently.

[00209] For those who cannot visually see the information on the monitor screen, a text to speech engine and program has been embedded. Those blind or vision impaired as well as those who are dyslexic will be able to hear the information upon the screen and operate the system without sighted assistance.

[00210] The text to speech settings page is found upon the settings > utilities > text to speech tab. Within this setting, you can set the speed in which the text is read, choose a male or female voice, and set the pitch of the voice chosen for best listening comprehension.

[00211] When any notification, alert, alarm or confirmation is received, it will be read by this text to speech program.

[00212] For audio alert notifications, you can choose how you are notified (e.g., various sounds or indicators). You can set the volume of the audio alerts, as well. The volume tab will allow you to raise or lower to your needed level.

[00213] Whenever an alert, alarm, notification etc. is received, the audio tones will be sure to catch your attention.

[00214] There are those whom are hearing impaired or deaf. Audio and/or the text to speech will not be able to be used. We have added a heavy vibration so those needing such accessibility alert notifications will be sure to know when to give the controller and system their undivided attention.

[00215] Even the pump, when upon your body, will vibrate. Just in case the controller is not nearby. The vibration from the pump will be sure you go looking for your controller to give appropriate attention to your system.

[00216] The controller and the pump both have a LED light that will flash when an alert or notification is received. The monitor screen will also flash brightly to catch the attention of those using. For those with hearing impairments, this continues the accessibility focus as with the vibration feature. The audio tones, vibration and flashing lights are all set within the settings > alarms/alerts page. By checking yes or no, you can choose what types or formats of alerts can and will be received.

[00217] This chapter provides information about common tasks for various settings.

[00218] Automatic Suspend is a safety feature that stops all insulin delivery and sounds an alarm if you do not press any buttons for a specified period of time. For example, your healthcare professional may have you set the time based on the number of hours that you typically sleep at night. Discuss with your healthcare professional how to best use this feature. The Automatic Suspend feature continues working when your pump switches to Automatic Mode. [00219] Carb counter:

[00220] The insulin pump system accessible insulin pump system comes with a carb counter with a food database able to be used to calculate the total grams of carbohydrates you may consume at meal time click on the food database and by either searching for a food item by name or by pressing a category to search by type of product as tater tots for example and not simply potatoes, you can determine the total grams of carbs within your meal.

[00221] By adding to the list of items in your meal and when finished, hitting total, the pre-set insulin ratio will give a bolus amount to be delivered.

[00222] The user can confirm the bolus or hit the back button to exit the counter. If you accept the bolus, you can receive a confirmation request and you simply hit ok and the bolus is then delivered.

[00223] The food database can be updated through your wi-fi connection. If there is an update available, the system will automatically download all updates without your need to perform this action.

[00224] Setting the insulin ratio for carbs:

1. go to: settings > delivery > carbs ratio

2. The ratio can be a basic number of units per a number of grams of carbs consumed or you can choose the 300 method.

3. Select save to confirm.

[00225] The carb counter can automatically calculate the number of units of insulin to be delivered through these settings and the carb counter application determining the total grams your meal will consist of.

[00226] Using the glucose sensor :

[00227] Within the infusion pad can include two sensors and a transmitter.

[00228] The two sensors are:

1. Glucose sensor

2. Ketone sensor [00229] Glucose sensor:

[00230] When you turn on the glucose Sensor, the Home screen on your controller can change to display real-time data which shows your sensor glucose (SG/CGM) information.

[00231] setting up continuous glucose monitoring:

[00232] When you place the infusion pad and command to automatically insert, the sensors along with the cannula can be automatically inserted into your soft tissue. [00233] Upon automatic insertion, the glucose sensor can pair with the transmitter and after an approximate 2-hour warm-up period, the controller can begin wirelessly receiving the data from the sensors.

[00234] While in airplane mode, the glucose sensor and the ketone sensor can be suspended. When the airplane mode is turned off, the information from the sensors can again begin being transmitted to the controller. The glucose sensor can send alerts and alarms if glucose levels are high or low.

[00235] While in automatic mode, if the low threshold is reached, all insulin delivery can be suspended until this threshold again rises above the pre-set low level. If the level runs high, while in automatic mode, the boluses can be handled by the controller and the closed loop system. [00236] All sensor history can be reviewed through the settings > history tab.

[00237] The ketone sensor also can monitor your ketone levels and alert you if preset threshold levels are high. The glucose sensor and ketone sensor settings are found within the utilities tab in the settings menu.

[00238] Understanding glucose settings:

[00239] There are several types of glucose alerts you can set to notify you if your glucose levels have reached a specified low or high limit. You can also set your pump to automatically suspend insulin delivery when you reach your low limit.

[00240] High settings:

[00241] These settings alert you if your sensor glucose:

1. has reached your high limit

• Your high limit is the value on which your other high settings are based.

• Your high limit can be set from 100 mg/dL to 400 mg/dL.

• You can set a different high limit for up to eight-time segments throughout the day or night.

[00242] Alert on high:

[00243] When Alert on high is on, your system can alert you when your SG reading reaches or exceeds your High Limit.

[00244] Low settings:

[00245] The low settings allow you to be alerted and/or have insulin delivery suspended when you have reached your low limit. This is done by using alerts.

[00246] Suspend on low:

[00247] When in automatic mode, the suspend on low can stop delivery of all insulin until your glucose level rises above your low setting.

[00248] Transmitter: [00249] Within the infusion pad is your transmitter. This transmitter can be synced with the glucose and ketone sensors and will send/transmit all readings/data to the controller. The transmitter has no control needs and is automatically synced with the sensors once insertion into your soft tissue is complete. The warm-up stage of 2-hours occurs when a new infusion pad is used.

[00250] The wireless connection with the controller can be suspended while the system is in airplane mode.

[00251] Calibrating the glucose and/or ketone sensors:

[00252] The glucose and ketone sensors need regular calibration so that you are aware of the accuracy of these sensors.

[00253] To calibrate:

1. Go to settings > sensor calibration.

2. test your glucose and/or ketone levels with your blood glucose and/or ketone blood monitors.

3. Put the new record into the appropriate edit field.

4. Press save

5. confirm

Once confirm has been pressed, the new value will be viewed upon the home page. [00254] Calibration not accepted:

[00255] Calibration not accepted alert occurs when one of the following happens:

• System was unable to use the BG meter readings you entered to calibrate your sensor.

• System rejects two calibrations in a row from the same sensor.

• The transmitter was unable to receive the calibration BG meter readings from the controller due to failed sensor signal.

[00256] In some examples, the insulin pump system includes a mobile data sharing application that you can use to have others (e.g., family members, caregivers, physicians) monitor the user’s data. Data that can be shared includes, but is not limited to: the current glucose level, the current ketone level, the most recent 90-day AIC average, insulin boluses delivered for the current day, and all alarms/alerts/notifications.

[00257] The user controls who is able to monitor the insulin pump system and the data previously noted. The user can create and delete contacts through the controller programming menu. After contacts are created, a message will be sent to each contact with a link to download the application. The contacts will begin monitoring once this application is installed. Once deleted, the deleted contact will no longer receive any of the shared data. In some examples, the contact will not be informed they have been deleted from sharing your data. [00258] Your system can include bluetooth technology to wirelessly connect to items such as ear phones/plugs/buds, a keyboard, or to your computer.

[00259] Connect to a device:

5. When the pairing is complete, you will receive a confirmation.

[00260] If you wish to use the ear buds, you will use your controller and follow these directions:

The text to speech from the controller will no longer be heard. Alarms/Alerts and notification alerts programmed with audio will continue through the controller as well as your ear plugs/buds. All text to speech will be heard through the connected ear plugs/buds.

[00261] After the user disconnects from a device utilizing the bluetooth connection, the device will not work with the insulin pump system until reconnected.

[00262] The controller and all data are connected via the wi-fi network connection. The wi-fi connection allows data sharing and updates to the controller of the insulin pump system.

[00263] Connecting to a wi-fi network:

• All contacts will again receive data shared.

• All updates will again automatically be received, installed and utilized.

[00264] Updates are automatic. You need to do nothing for the updates to be received. As long as you have wi-fi connection established, the updates will not need any assistance from you. Storage mode allows you to safely place your pump in storage while not in use. Always save your settings before putting your system into storage mode.

1. Go to settings > utilities > save your settings

2. click on save settings.

• Your settings will now be saved in case you need to restore them when you bring the system out of storage mode.

• Your controller and system will now completely shut down, power down, in 5- minutes. You are able to cancel this feature by going back to storage mode and hitting the cancel storage mode.

• The system will not shut down upon cancellation of storage mode and a notification will appear on the screen.

• If you place your pump in storage mode, it is important to understand that the controller and pump will enter into a deep discharge status. The rechargeable batteries that are deeply discharged takes longer to charge than a normal battery charge.

• 1 below 41 °F (5 °C) or above 104 °F (40 °C). Storing your pump in temperatures outside of this range may damage your pump.

[00265] Basal delivery: [00266] The Delivery rate range can be about 0 to about 35 units per hour or the Max Basal Rate amount, whichever is lower. The Max Basal Rate default can be about2 units per hour. [00267] Basal blocks: There can be a set maximum of about 8 blocks. Each block covers a specified period of time and can have up to 48 rates. Rates can be set in 30-minute increments. [00268] BG Target:

• Maximum targets: 8

• Range: 60 to 250 mg/dL

• Bolus Speed options: Standard: about 1.5 units/minute

• Fluid delivered/stroke: about 0.25 pL (microliter) for 0.025-unit pump stroke

• Active insulin time: 4-hours to 8-hours 15 -minutes.

[00269] Maximum ratio settings: Range

[00270] 8: about 1 to about 200 grams/unit

[00271] Vibrate mode range: about 0 to about 20 increments or Max Bolus limit, whichever comes first.

[00272] · Infusion pressure:

[00273] The maximum infusion pressure and occlusion pressure are about 13.15 psi (90.67 kPa).

[00274] · Low Reservoir reminder:

[00275] The values are based on displayed amount, not actual amount.

[00276] Alert range:

[00277] First reminder occurs at about 5 to about 50 units. Second reminder occurs at about 50 percent of the remaining specified amount. The second reminder can be automatic and cannot be changed by the user.

[00278] Max Bolus:

[00279] Range: about 0.1 to about 25 units

[00280] Normal bolus:

[00281] Range is about 0.1 to about 25 units of insulin, and limited by the Max Bolus setting. Pump and infusion pad approximate dimensions (when connected together), these are intended to be examples only: Inches: 2.0" width x 1.5" length x 0.625" height centimeters: 5.08 width x 3.81 length x 1.59 depth.

[00282] · Pump memory:

[00283] User settings and pump history are stored in non-volatile memory which will retain data.

[00284] Still another embodiment involves a computer-readable medium comprising processor-executable instructions configured to implement one or more of the techniques presented herein. An exemplary computer-readable medium is illustrated in Fig. 24, wherein the embodiment 1000 comprises a computer-readable medium 1002 (e.g., a CD-R, DVD-R, flash drive, a platter of a hard disk drive, etc.), on which is encoded computer-readable data 1004. This computer-readable data 1004 in turn comprises a set of processor-executable computer instructions 1006 configured to operate according to one or more of the principles set forth herein. In some embodiments 1000, the processor-executable computer instructions 1006 are configured to perform a method 1008, such as at least some of the aforementioned described methods. In some embodiments, the processor-executable computer instructions 1006 are configured to implement a system, such as at least some of the aforementioned systems. Many such computer- readable media may be devised by those of ordinary skill in the art that are configured to operate in accordance with the techniques presented herein.

[00285] Fig. 25 and the following discussion provide a brief, general description of a suitable computing environment to implement embodiments of one or more of the provisions set forth herein. The operating environment of Fig. 25 is only one example of a suitable operating environment and is not intended to suggest any limitation as to the scope of use or functionality of the operating environment. Example computing devices include, but are not limited to, personal computers, server computers, hand-held or laptop devices, mobile devices (such as mobile phones, Personal Digital Assistants (PDAs), media players, and the like), multiprocessor systems, consumer electronics, mini computers, mainframe computers, distributed computing environments that include any of the above systems or devices, and the like.

[00286] Although not required, embodiments are described in the general context of "computer readable instructions" being executed by one or more computing devices. Computer readable instructions may be distributed via computer readable media (discussed below). Computer readable instructions may be implemented as program modules, such as functions, objects, Application Programming Interfaces (APIs), data structures, and the like, that perform particular tasks or implement particular abstract data types. Typically, the functionality of the computer readable instructions may be combined or distributed as desired in various environments.

[00287] Fig. 25 depicts an example of a system 1100 comprising a computing device 1102 to implement some embodiments provided herein. In some configurations, computing device 1102 includes at least one processing unit 1104 and memory 1106. Depending on the exact configuration and type of computing device, the memory 1106 may be volatile (such as RAM, for example), non-volatile (such as ROM, flash memory, etc., for example) or some combination of the two. This configuration is illustrated in Fig. 11 by dashed line 1108.

[00288] In some embodiments, the computing device 1102 may include additional features and/or functionality. For the example, the computing device 1102 may also include additional storage (e.g., removable and/or non-removable) including, but not limited to, magnetic storage, optical storage, and the like. Such additional storage is illustrated in Fig. 11 by storage 1110. In some embodiments, computer readable instructions to implement one or more embodiments provided herein may be in the storage 1110. The storage 1110 may also store other computer readable instructions to implement an operating system, an application program, and the like. Computer readable instructions may be loaded in the memory 1106 for execution by processing unit 1104, for example.

[00289] The term "computer readable media" as used herein includes computer storage media. Computer storage media includes volatile and nonvolatile, removable and non-removable media implemented in any method or technology for storage of information such as computer readable instructions or other data. The memory 1106 and storage 1110 are examples of computer storage media. Computer storage media includes, but is not limited to, RAM, ROM, EEPROM, flash memory or other memory technology, CD-ROM, Digital Versatile Disks (DVDs) or other optical storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other medium which can be used to store the desired information and which can be accessed by the computing device 1102. Any such computer storage media may be part of the computing device 1102.

[00290] In some embodiments, the computing device 1102 comprises a communication interface 1112, or a multiple communication interfaces, that allow the computing device 1102 to communicate with other devices. The communication interface 1112 may include, but is not limited to, a modem, a Network Interface Card (NIC), an integrated network interface, a radio frequency transmitter/receiver, an infrared port, a Universal Serial Bus (USB) connection, or other interface for connecting the computing device 1102 to other computing devices. The communication interface 1112 may implement a wired connection or a wireless connection. The communication interface 1112 may transmit and/or receive communication media.

[00291] The term "computer readable media" may include communication media. Communication media typically embodies computer readable instructions or other data in a "modulated data signal" such as a carrier wave or other transport mechanism and includes any information delivery media. The term "modulated data signal" may include a signal that has one or more of its characteristics set or changed in such a manner as to encode information in the signal.

[00292] The computing device 1102 may include input device(s) 1114 such as keyboard, mouse, pen, voice input device, touch input device, infrared cameras, video input devices, and/or any other suitable input device. An output device(s) 1116 such as one or more displays, speakers, printers, and/or any other suitable output device may also be included in the computing device 1102. The input device 1114 and the output device 1116 may be connected to the computing device 1102 via a wired connection, wireless connection, or any combination thereof. In some embodiments, an input device or an output device from another computing device may be used as the input device(s) 1114 or the output device(s) 1116 for the computing device 1102.

[00293] Components of the computing device 1122 may be connected by various interconnects, such as a bus. Such interconnects may include a Peripheral Component Interconnect (PCI), such as PCI Express, a USB, firewire (IEEE 1394), an optical bus structure, and the like. In some embodiments, components of the computing device 1102 may be interconnected by a network. For example, the memory 1106 may be comprised of multiple physical memory units located in different physical locations interconnected by a network.

[00294] Those skilled in the art will realize that storage devices utilized to store computer readable instructions may be distributed across a network. For example, a computing device 1118 accessible via a network 1120 may store computer readable instructions to implement one or more embodiments provided herein. The computing device 1102 may access the computing device 1118 and download a part or all of the computer readable instructions for execution. Alternatively, the computing device 1102 may download pieces of the computer readable instructions, as needed, or some instructions may be executed at the computing device 1102 and some instructions may be executed at the computing device 1118.

[00295] Further points of consideration:

[00296] ACE (Alternate Controller Enabled) system with text to speech (talking controller) for those blind or dyslexic.

[00297] controller and pump each having vibration and flashing lights for those deaf [00298] Controller having scroll wheel for those with motor issues with their hands.

[00299] Pump: tubeless and reusable.

[00300] Insulin Cartridge and infusion pad synced via computer chip so only paired items can/will work together. This to prevent insulin cartridge and infusion pad from being re-used. [00301] Insulin cartridge chamber, within insulin pump, temperature controlled to prevent degradation of insulin within said insulin cartridge.

[00302] Infusion pad/insulin cartridge computer sync chip also has timer not to exceed 96- hours. added security to prevent degradation of insulin within said cartridge.

[00303] needle cap: This needle cap locks the insulin cartridge into the pump cartridge chamber. The needle on the cap penetrates a septum within the infusion pad, allowing the transfer of insulin from the insulin cartridge, out through the needle cap, through the infusion pad septum, down through a cannula, inserted into the user’s soft tissue, and exiting into the subcutaneous or soft tissue of the user. [00304] Infusion pad to have automatically inserted cannula/syringe that releases insulin into the body, continuous glucose monitor (CGM) to monitor glucose levels and a continuous ketone monitor (ckm) to monitor the ketone levels of the user. The monitors within this infusion pad and data /level readings, transferred to controller via wireless (wi-fi) transfer.

[00305] Blue tooth connectivity to connect to ear plugs/headphones, keyboards and computers. [00306] controller ergonomic shape and tactile buttons for those with motor issues with their hands, those with numbness/neuropathy or arthritis in their hands and to assist the blind in finding the buttons needed.

[00307] controller has scroll wheel for those with motor issues with their hands.

[00308] pump attaches to infusion pad and pump is reused, infusion pad one-time use only. [00309] infusion pad has ketone and glucose sensors within that are automatically inserted into user’s soft tissue.

[00310] both controller and pump utilize magnetic charging with rechargeable batteries/power supplies.

[00311] insulin pump needle cap, transfers insulin from cartridge through infusion pad and into soft tissue of user.

[00312] pump powers infusion pad and all components within.

[00313] add find feature. If it’s within the wifi area, then can find controller. Like air tags. Where is the user? Pump has a chip, and search on smart phone. Give general vicinity of pump which should be attached to the body. Could do a cell tower, too, or as an alternative.

[00314] BENEFITS:

[00315] Pump and infusion set all-in-one is what’s available. Too expensive. 2. Tubeless. 3. Pump is reusable. Known systems are often too large, sometimes cannot stay attached to the user. Can’t use smart phone to read status of pump, etc. Must carry extra controller. The current controller is not smart.

[00316] Text-to-speech, vibration, etc.

[00317] Rechargeable batteries in controller — magnetically operated.

[00318] Ergonomic design = held easily left or right hand. Keys can include tactile indications of specific keys.

[00319] It will free up individuals with diabetes of being tethered to their pumps via a tube.

[00320] It will provide consistent, round-the-clock, uninterrupted insulin delivery.

[00321] It will allow for easier set up and automated cannula insertion.

[00322] Greater ease of use leads to a greater level of compliance

[00323] Reduce effects of diabetes for those who could not use standard products.

[00324] Reduce healthcare costs and hospitalization times. [00325] Improved communication control of pump and infusion without need for smartphone. [00326] This insulin pump can also have lighted signals/alarms/notifications and vibration technology for those who are deaf or hearing impaired as well as proper ergonomic and tactile effects for those with motor skills issues with their hands. Low battery [00327] Low insulin level

[00328] Can pick between siren, others. Will read, “alert, alert, low battery, recharge.” Same with insulin. Can increase seriousness for increased seriousness of the issue.

[00329] Blind user might not need flashing light. Can turn that off. Deaf may need light and vibration.

[00330] The Insulin Pump System will offer the comfort and safety of feedback and alarms, the ability to follow daily, monthly, and quarterly progress, and the feeling of accomplishment in managing one’ s own diabetes for those previously not being able to independently and safely use a pump for the control of their diabetes through insulin pump therapy.

[00331] Individuals using multiple daily injections (MDI) typically inject four times a day or more, usually using two different types of insulin. The appeal of insulin pumps has been that they eliminate the need for these injections while allowing for greater customization and tailoring of insulin delivery. Insurers recognize the benefits to certain individuals; for example, to get reimbursement for insulin pump therapy in the EU, the individual must have one or more of these indications:

[00332] · Dawn phenomenon

[00333] · Severe hypoglycemia unawareness

[00334] · An irregular daily schedule, such as people who work various shifts or have unforeseen physical activities requiring a reduction of basal insulin [00335] · Pregnancy

[00336] · Diabetes complications that require very tight glucose control

[00337] Continuous subcutaneous insulin infusion (CSII) therapy is not limited to those populations. It can benefit any individual with type I or type II diabetes. Use of an insulin pump frees the user from the strict eating schedule required when using long and intermediate-acting insulin, and allows increased flexibility in daily activities. While the basal (or background) dosage is pre-programmed, it can be changed as needed.

[00338] While pumping is freeing in some respects, it is also an added responsibility. Because pumps use rapid-acting insulin analogs, any interruption in insulin delivery may result in hyperglycemia and the rapid onset of diabetic ketoacidosis. In addition, traditionally designed systems have a number of limitations that could be improved upon to allow more individuals with diabetes to benefit from CSII therapy. These include: [00339] · Long tubing connects the insulin reservoir in a traditional pump to the infusion set.

The tubing has to be managed by patients in all aspects of daily living (dressing, exercising, etc.). This tubing can catch on things during daily use, resulting in disruption of insulin delivery.

[00340] · The process of inserting the cannula with present-day mechanical inserters or by hand is awkward and can result in variable cannula insertion angles and depths. This mechanical or manual cannula insertion process can be intimidating to some individuals.

[00341] · Managing the large number of components required during setup and infusion set changes is complex.

[00342] · Locations to insert infusion sets are relatively limited.

[00343] Relatively high cost to the user with insulin pumps that are not reusable.

[00344] Additionally, users will not need to be “technologically savvy,” because the device’s user interface will be very clear, straight forward and simple. Almost all individuals with type I and type II diabetes will benefit from using the Zeus Insulin Pump System.

[00345] Communicating with the user, The communications are: vibration, flashing lights, text to speech (voice) reading the text alerts aloud, text alerts upon the monitor and audible tones as sirens etc.

[00346] The Ketone meter/sensor will send the readings wirelessly to the controller. If the Ketone level is found to be high in regards to thresholds set within settings, the controller will notify the user via an alert of which may be text to speech spoken voice information, text upon the monitor screen focus, vibration, flashing lights or audible alerts as a siren, for example. The Ketone level may be monitored by those sharing and monitoring the data through the data sharing application as part of the operating system. The user or one sharing the data of the user, a treating Physician/Endocrinologist or family member, for example, will know of the need to discuss the user’s condition for immediate attention needs.

[00347] The Carbohydrate Counter is based upon a database of foods and their carbohydrate levels if/when eaten/digested. Therefore, the preset thresholds set within the settings of the Controller will know what amount of insulin to deliver by the total grams of carbohydrates to be consumed. The Ketone levels do nothing towards this point and need be removed. The database of foods will be continuously updated when the system is connected via bluetooth, USB/hard wire or wi-fi.

[00348] Application for authorized individuals to share/monitor the data within the controller. This being daily history of insulin received, glucose levels and ketone levels within a 24-hour period. [00349] The Insulin Pump can include unique user software & voice technology that can deliver unparalleled accessibility for those who are blind or are vision impaired.

[00350] The Find Feature has two considerations.

[00351] 1. Where’s my controller: When the controller is unable to be located, the user can go to their smart phone or computer to send a signal to the controller to be located. If within an audible distance, the user may hear an alarm to help direct the individual to find/locate the lost controller. If the controller alarm is not able to be heard and the controller not found within a period of time, a map will be displayed in both graphical and text format so the user will know an area the controller is located. This may allow the user to recall where they may have been to then go to that location and retrieve the said controller.

[00352] 2. Where’s the User?

[00353] This feature helps individuals locate the diabetic wearing the pump. The pump will have the micro-chip that will be able to be traced/tracked so the individual wearing the pump can be found. If a diabetic’s glucose level goes too low, they may not be able to find their way home to gain needed consumables to raise their glucose level. If one is sharing the data through the application discussed previously, they can do the search and alert authorities of the diabetic and have needed assistance for the diabetic given.

[00354] Unless specified otherwise, “first,” “second,” and/or the like are not intended to imply a temporal aspect, a spatial aspect, an ordering, etc. Rather, such terms are merely used as identifiers, names, etc. for features, elements, items, etc. For example, a first object and a second object generally correspond to object A and object B or two different or two identical objects or the same object.

[00355] Moreover, “example” is used herein to mean serving as an instance, illustration, etc., and not necessarily as advantageous. As used herein, “or” is intended to mean an inclusive “or” rather than an exclusive “or.” In addition, “a” and “an” as used in this application are generally be construed to mean “one or more” unless specified otherwise or clear from context to be directed to a singular form. Also, at least one of A and B and/or the like generally means A or B or both A and B. Furthermore, to the extent that “includes,” “having,” “has,” “with,” and/or variants thereof are used in either the detailed description or the claims, such terms are intended to be inclusive in a manner similar to the term “comprising.”

[00356] Although the subject matter has been described in language specific to structural features and/or methodological acts, it is to be understood that the subject matter defined in the appended claims is not necessarily limited to the specific features or acts described above.

Rather, the specific features and acts described above are disclosed as example forms of implementing at least some of the claims. [00357] Various operations of embodiments are provided herein. The order in which some or all of the operations are described herein should not be construed as to imply that these operations are necessarily order dependent. Alternative ordering will be appreciated by one skilled in the art having the benefit of this description. Further, it will be understood that not all operations are necessarily present in each embodiment provided herein. Also, it will be understood that not all operations are necessary in some embodiments.

[00358] Also, although the disclosure has been shown and described with respect to one or more implementations, equivalent alterations and modifications will occur to others skilled in the art based upon a reading and understanding of this specification and the annexed drawings. The disclosure includes all such modifications and alterations and is limited only by the scope of the following claims. In particular regard to the various functions performed by the above described components (e.g., elements, resources, etc.), the terms used to describe such components are intended to correspond, unless otherwise indicated, to any component which performs the specified function of the described component (e.g., that is functionally equivalent), even though not structurally equivalent to the disclosed structure. In addition, while a particular feature of the disclosure may have been disclosed with respect to only one of several implementations, such feature may be combined with one or more other features of the other implementations as may be desired and advantageous for any given or particular application.

Claims

What is claimed is:

1. An insulin pump system comprising: an insulin pump wearable by an associated user, the insulin pump in fluid communication with a subcutaneous volume of the associated user, the insulin pump configured to move a quantity of insulin into the subcutaneous volume; and a controller in electronic communication with the insulin pump, the controller configured to control operation of the insulin pump to meter the quantity of insulin moved to the subcutaneous volume, the controller configured to communicate with the user with at least one of bluetooth, radio frequency (RF), or wireless communication.

2. The insulin pump system of claim 1 , the controller configured to communicate with the user with at least one of a vibration, a pulsing movement, a flashing device, text to speech, or an audible tone.

3. An insulin pump system comprising: an insulin pump wearable by an associated user, the insulin pump in fluid communication with a subcutaneous volume of the associated user; an insulin cartridge in fluid communication with the insulin pump, the insulin pump configured to move a quantity of insulin from the insulin cartridge into the subcutaneous volume; a thermal control unit configured to provide a thermally controlled environment around the insulin cartridge; and a controller in electronic communication with the insulin pump, the controller configured to control operation of the insulin pump to meter the quantity of insulin moved from the insulin cartridge to the subcutaneous volume.

4. An insulin pump system comprising: an insulin pump wearable by an associated user, the insulin pump in fluid communication with a subcutaneous volume of the associated user, the insulin pump configured to move a quantity of insulin into the subcutaneous volume; and a remote control device including a controller in electronic communication with the insulin pump, the controller configured to control operation of the insulin pump to meter the quantity of insulin moved to the subcutaneous volume, the remote control device including text- to-speech software to enable provision of information to the associated user having at least one of a vision impairment or a reading impairment.

5. The insulin pump system of claim 4, the remote control device including a scroll wheel to enable the associated user to at least one of input information into the controller, access operating menus, or scroll through operating menus.

6. An insulin pump system comprising: an insulin pump wearable by an associated user, the insulin pump in fluid communication with a subcutaneous volume of the associated user; an infusion pad; an insulin cartridge attached directly to the insulin pump such that no tubing is required between the insulin cartridge and the infusion pad; and a controller in electronic communication with the insulin pump, the controller configured to control operation of the insulin pump to meter a quantity of insulin moved from the insulin cartridge to the subcutaneous volume.

7. The insulin pump system of claim 6, wherein the insulin pump is configured to be detached from the insulin cartridge and the insulin pump is configured to be used with more than one insulin cartridge.

8. The insulin pump system of claim 6, wherein the insulin cartridge and the infusion pad are paired such that the insulin cartridge and the infusion pad will work only as a matching pair.

9. The insulin pump of claim 8, wherein: the infusion pad includes a first computer chip, and the insulin cartridge includes a second computer chip such that the first computer chip of the infusion pad communicates with the second computer chip of the insulin cartridge to electronically pair the infusion pad to the insulin cartridge.

10. The insulin pump system of claim 8, wherein the pairing of the insulin cartridge and the infusion pad limit a total length of operation time of the insulin cartridge and the infusion pad.

11. The insulin pump system of claim 6, comprising a needle cap attached to the insulin cartridge configured to penetrate a septum defined by the infusion pad and lock the insulin cartridge to a pump cartridge chamber defined by the insulin pump.

12. The insulin pump system of claim 11, comprising a needle attached to the needle cap, the needle enabling transfer of the quantity of insulin from the insulin cartridge, through the needle cap, through the septum of the infusion pad, through a cannula, into a soft tissue of the associated user, and exiting into the subcutaneous volume of the associated user.

13. The insulin pump system of claim 12, wherein the cannula is automatically inserted into the associated user to release insulin into the subcutaneous volume of the associated user.

14. The insulin pump system of claim 6, comprising a continuous glucose monitor (CGM) to monitor a glucose level within the associated user, wherein the glucose level is wirelessly transferred to the controller.

15. The insulin pump system of claim 14, wherein the controller includes a computer program configured to: compare the glucose level to a target glucose level, and send a signal to the insulin pump to control operation of the insulin pump to alter the quantity of insulin moved from the insulin cartridge to the subcutaneous volume.

16. The insulin pump system of claim 6, comprising a continuous ketone monitor (CKM) to monitor a ketone level within the user, wherein the ketone level is wirelessly transferred to the controller.

17. The insulin pump system of claim 16, wherein the controller is configured to: compare the ketone level to a target ketone level, and send a signal to the insulin pump to control operation of the insulin pump to alter the quantity of insulin moved from the insulin cartridge to the subcutaneous volume.

18. The insulin pump system of claim 6, comprising a remote control device in electronic communication with the insulin pump, wherein: the remote control device configured to enable input of dietary intake data for the associated user, the controller configured to determine a value of carbohydrates ingested based upon the input of the dietary intake data, and the controller configured to determine a bolus dosage of insulin to be moved from the insulin cartridge to the subcutaneous volume, wherein: the bolus dosage based on the value of carbohydrates ingested, and application of the bolus dosage preemptively regulates a glucose level within the associated user based upon a predicted glucose level change or a predicted ketone level change anticipated by the value of carbohydrates ingested.

19. The insulin pump system of claim 18, wherein: the controller configured to send a signal to the insulin pump to control operation of the insulin pump to meter the bolus dosage of insulin to be moved from the insulin cartridge to the subcutaneous volume.

20. The insulin pump system of claim 6, comprising a needle cap having a first position and a second position, wherein: when in the first position, the needle cap is separate from the insulin cartridge, when in the second position, the needle cap is attached to the insulin cartridge, and movement of the needle cap from the first position to the second position causes the controller to automatically operate the insulin pump to meter a quantity of insulin from the insulin cartridge in order to at least one of reduce or remove air from a flow path of the insulin between the insulin cartridge and the subcutaneous volume of the associated user.