Patent Grant
12115338
Any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet as filed with the present application are incorporated by reference under 37 CFR 1.57 and made a part of this specification.
A portion of the disclosure of this patent document contains material to which a claim for copyright is made. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in the Patent and Trademark Office patent file or records, but reserves all other copyright rights whatsoever.
The disclosure relates generally to the field of infusion systems for medicaments and components thereof.
For the treatment of certain diseases, including diabetes, medicament pumps can be used to deliver medicines to the patient.
Sustained delivery, pump driven medicament injection devices generally include a delivery cannula mounted in a subcutaneous manner through the skin of the patient at an infusion site. The pump draws medicine from a reservoir and delivers it to the patient via the cannula. The injection device typically includes a channel that transmits a medicament from an inlet port to the delivery cannula which results in delivery to the subcutaneous tissue layer where the delivery cannula terminates. Some infusion devices are configured to deliver one medicament to a patient while others are configured to deliver multiple medicaments to patient.
A drawback of traditional multi-medicament (e.g., pharmaceutical, hormone, etc.) and certain single medicament regimens is that the patient or physician may accidentally load, transfer, and/or administer the incorrect medicament into the incorrect medicament pump chamber. The accidental administration of the incorrect medicament to the patient can have serious and potentially fatal consequences. For example, standard-of-care insulin therapies for regulating blood glucose in diabetic patients may involve subcutaneous infusion of insulin via an insulin pump. If the amount of dosed insulin is excessive, it can lead to hypoglycemia or a situation of impending hypoglycemia. In some situations, individuals can administer a so-called “rescue dose” of a counter-regulatory agent, such as glucagon. A counter-regulatory agent combats the effect of the excess medicinal dose (e.g., excess insulin) alleviating or substantially preventing adverse effects related to the excess dose.
In a multi-medicament automated system, if the medicaments are accidentally loaded in the incorrect reservoirs or incorrect chambers of a pump, the automated system could deliver an ineffective (and potentially harmful) medicament to the patient. This phenomenon of incorrect medicament administration in automated systems is called cross-channeling. Cross-channeling is dangerous because the wrong medicament could have the opposite of the intended effect or a side effect that is unanticipated. This improper channeling could not only fail to alleviate the patient's condition, but could make the patient's condition worse, or cause a new problem-state for the patient. For example, instead of delivering a rescue dose of a counter-regulatory agent, the delivery system could infuse more and more therapeutic into the patient, exacerbating the issue it was meant to resolve.
Described herein are infusion systems for multiple medicaments (or single medicaments) and various connectors, tubes, cartridges, and pump features that ensure, help ensure, and/or substantially aid in providing proper channeling of each medicament to the patient. Any of the connectors, tubes, cartridges, and pump features used in one embodiments may be mixed and matched to provide systems for lowering the likelihood of mischanneling. Additionally, one or more features disclosed herein may be omitted from an embodiment. While certain embodiments, of infusion systems and components are described below to illustrate various examples that may be employed to achieve one or more desired improvements, these examples are only illustrative and not intended in any way to restrict the general inventions presented and the various aspects and features of these inventions. The phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. No features, structure, or step disclosed herein is essential or indispensable.
Some embodiments disclosed herein refer to the use of a regulatory agent alone or in combination with a counterregulatory agent. In some embodiments, where the disease to be treated is diabetes, the regulatory agent is insulin and the counterregulatory agent is glucagon. While diabetic drugs are used as an example elsewhere herein, improper channeling can have deleterious effects in many multi-medicament regimens (e.g., in drugs that regulate pancreatic enzymes, etc.) because a medicament is not administered to the patient at the necessary time or an incorrect medicament is administered at a dangerous level. Thus, the embodiments and considerations provided herein can be applied to any drug individually and/or any drug combination. Additionally, while cross-channeling can refer to systems where two medicaments are inserted into the incorrect chambers of a distribution system, the term cross-channeling as used herein can also refer to systems were more than two medicaments are used and/or where a single medicament is used (for example, when a single medicament is improperly placed in a distribution system).
System Overview
Some embodiments described herein pertain to an infusion system for dosing multiple medicaments (or a single medicament) without cross-channeling. In some embodiments, cross-channeling is avoided by providing design features and/or mating connectors or adapters on certain components of the infusion system. For instance, in some embodiments, the infusion system comprises an infusion pump with one, two, or more infusion chambers (or pump chambers), drive shafts. In some embodiments, the system further comprises cartridges filled with different medicaments, and connectors and tubing that connect to the cartridge to the infusion pump in such a way as to prevent mischanneling or cross-channeling of medicaments. In certain variants, each type of cartridge for each type of medicament has one or more unique differentiating features (either as an integral part of the cartridge or as a component attached or affixed to the cartridge), for example geometric or shape-based features, that allow for unique coupling with a type of connector that itself has unique differentiating features that engage corresponding features in the pump housing and allow for insertion of the proper cartridge into the proper infusion chamber, drive shaft, or pump chamber within the infusion pump.
In certain variants, the system comprises an infusion set. In some embodiments, the infusion set comprises a base with a housing having one or more implements (e.g., delivery members, needles, etc.) that allow delivery medicaments to the patient from the system. In some variants, the housing is connected to a distribution set comprising one or more distribution connectors that are configured to receive a medicament from one or more medicament cartridges (e.g., via a conduit etc.). In some embodiments of the system, one or more fluid conduits provide fluidic communication between the cartridges (e.g., medicament reservoirs) and a distribution connector set. In various implementations, the connector set comprises one or more cartridge connectors that couple the fluid conduits to the medicament reservoirs. In some variants of the system, the cartridge or cartridges is or are located in (and/or can be placed in) a pumping device configured to distribute the medicament from the cartridge or cartridges to the conduit, thereby supplying the system with one or more medicaments. In some embodiments, the fluid conduits provide separate pathways that terminate at designated delivery members (e.g., needles, cannulas, etc.) within the base, thereby enabling independent delivery (e.g., subcutaneous or otherwise) of medicaments separately.
An improved infusion system for multiple medicaments and multiple connectors ensures, helps to ensure, and/or substantially aids in providing proper channeling of each medicament to the patient. In other words, where multiple medicaments are supplied by the infusion systems, the features and/or components described herein are configured to prevent, minimize the occurrence of, or otherwise inhibit the opportunity for a user to inadvertently place a medicament in the incorrect cartridges or to place a cartridge in the incorrect pump chamber. In some embodiments, alternatively, where more than one cartridge is present, both cartridges may comprise a single medicament (e.g., insulin). By providing a system that accommodates two cartridges of the same medicament (and that prevents or inhibits the insertion of cartridges having other medicaments), a user is able to allow the pump to operate for a longer period of time without the need for refilling or adding additional cartridges. Moreover, an expended single cartridge (e.g., one that is empty or close to empty) can be changed on fly by the user without disrupting the flow of medicine from a second cartridge that is providing the medicament to the patient.
Pump and Cartridge Connectors
An improved embodiment of a multiple medicament pump (including the pump housing) and the one or more cartridge connectors configured to attach to a medicament cartridge is provided in
Shown in
In some embodiments, as shown in
As disclosed elsewhere herein, both the individual cartridge connectors 1201, 1202 and the pump chambers 1101, 1102 may be formed to prevent attachment of the incorrect cartridge connector with the incorrect pump chamber. For example, as illustrated in
Some embodiments provide for each of the pump chambers having two or more detent cams to facilitate attachment of and prevent disconnection of a cartridge connector from the pump housing. In some embodiments, the pump chamber can include a first “shallow” detent cam that comprises a smaller transition angle than a second “step” detent cam that comprises a larger transition angle. In some embodiments, as the cartridge connector (and corresponding detent lug) is inserted into the opening of the corresponding pump chamber, the cartridge connector is rotated in a first direction to lock the connector into the pump chamber. In some embodiments, while the connector is rotated, one or more of the lugs may abut against and travel along the first “shallow” detent cam until the lug reaches a clearance configured to receive the lug. The clearance may be bordered by the second “steep” detent cam, which would require a greater rotating force in an opposite direction to permit the lug to overcome the second cam and to remove the lug from the clearance. In some embodiments, therefore, the combination of the different detent cams causes cartridge connector to require a greater amount of force to remove the cartridge connector from the pump chamber once it is locked to the pump than the initial amount of force that is required to lock the cartridge connector to the pump chamber. Shown in
As disclosed elsewhere herein, some embodiments provide openings to the pump chambers having various lug opening sizes configured to receive each of the various cartridge connector lugs. Examples are shown in
As described herein, once the cartridge connector is inserted into the pump chamber opening, the connector is rotated to lock the smallest cartridge lug within the lug clearance in the pump chamber. For example, the connector may be rotated a quarter turn to lock to pump chamber. As such, the larger lug of the cartridge connector in initially inserted though the larger lug opening and then is rotated a quarter turn to a position under the smaller lug opening of the pump chamber. The alignment of the larger lug under the smaller opening inhibits removal of the cartridge connector from the pump chamber once locked since the larger lug cannot pass through the smaller lug opening.
As disclosed elsewhere herein, some embodiments provide for each of the cartridge connectors being shaped so as to provide a visual and/or tactile indication of when the cartridge connector is locked with the pump chamber. For example, in some embodiments, a knob or other physical structure on the cartridge may indicate the orientation of the cartridge and whether the cartridge is in a locked position once the cartridge is inserted into the pump chamber.
As shown in
In some embodiments, as disclosed elsewhere herein, the orientation of the “Knob” feature of the Cartridge Connectors may allow insertion with asymmetric alignment and locking with symmetric alignment after clockwise quarter turn (or counter clockwise, or both).
In some embodiments, as disclosed elsewhere herein, the chamber diameters may be different and as shown in
In some embodiments, an O-ring is not used in this design at the cartridge connector. In some embodiments, the cartridge connectors are not designed to seal the housing and the housing sealing function is elsewhere. Therefore, the cartridge chambers are permitted to “breath” as required (to avoid runaway dosing upon pressure changes in, for example, an airplane).
Cartridge Connectors
In some embodiments, both the individual cartridge connector shrouds and the individual medicament cartridges may be formed to prevent attachment of the incorrect cartridge connector with the incorrect medicament cartridge. For example, as illustrated in
In other embodiments, the shroud of the insulin cartridge is longer to avoid engaging a glucagon cartridge that may be wider than the insulin cartridge.
In some embodiments, as shown in
In some embodiments, as disclosed elsewhere herein, the connector set comprises one or more cartridge connectors that couple the fluid conduits (shown in
As shown in
In some embodiments, “grip ribs”, as shown in
Some embodiments pertain to methods of making a cartridge connector. In some embodiments, as shown in
In some embodiments, as shown in
As disclosed elsewhere herein and as shown in
In some embodiments, as disclosed elsewhere herein, the cartridge connectors comprise different length skirts. As shown in
It should be appreciated that any of the features of the cartridge connectors, pumps, and/or cartridges disclosed herein (e.g., retention lugs (shape, size, and position), detents (shape, size, and position), skirts (length and diameter), threading (e.g., different directional, such as clockwise counter clockwise), cartridge connectors (shape, size, and position), coinciding receiving portions on the pump receptacles, etc.) may be used in combination to provide multiple cartridge connectors and pumps that avoid mischanneling. Likewise, one or more of features disclosed herein for the cartridge connectors (e.g., retention lugs and detents) could instead be provided on the pump receptacle and the coinciding pump features described above (lug and detent tracks) could instead be provided on the cartridge connectors. Moreover, as disclosed elsewhere herein, the cartridge connectors, pumps, and/or cartridges disclosed herein could lack one or more features disclosed herein.
Check Valve
Some embodiments, provides for the cartridge connector including a valve along a medicament fluid pathway within the cartridge connector that is configured to prevent unintentional leaking of the medicament from the medicament cartridge and/or retraction of fluid back into the cartridge once expelled. For example, the valve allows fluid to pass only after reaching a threshold pressure (e.g., a crack pressure) within the cartridge. The threshold pressure needed to allow fluid flow passed the valve can be greater than any gravitationally induced hydrostatic pressure differential that might develop between the patient and the infusion system to prevent inadvertent leaking. By way of another example, the valve may comprise a unidirectional valve such that the valve permits fluid flow in one direction (e.g., from the cartridge towards the patient) but inhibits fluid flow through the valve in the opposite direction.
In some embodiments, the flow path is as follows. In some embodiments, fluid flows up the needle (from the drug cartridge). In some embodiments, the fluid exits the needle below the valve filling the space. In some embodiments, when sufficient fluid pressure is generated by the plunger of the cartridge pushing out the fluid, then the perimeter of the valve cracks open to relieve the pressure. In some embodiments, the fluid gathers on the top side of the valve and flows through slots arranged around the pre-load rib. In some embodiments, the fluid then flows up the tube on its way to the patient. In some embodiments, the valve provides checked flow, where in the event that the fluid attempts to flow the other direction (i.e. from the tube back into the drug cartridge), the valve will remain closed stopping this flow.
In some embodiments, the valve is a ring valve. In some embodiments, the ring valve includes or consists of a silicone ring (labeled “tubing” in
In some embodiments, the flow path through the ring valve is as follows. In some embodiments, fluid flows up the needle (from the drug cartridge). In some embodiments, the fluid abuts the ring valve. In some embodiments, when sufficient fluid pressure is generated by the plunger of the cartridge pushing out the fluid, then the perimeter of the ring valve cracks open to relieve the pressure. In some embodiments, the fluid then flows up the tube on its way to the patient. In some embodiments, the valve provides checked flow, where in the event that the fluid attempts to flow the other direction (i.e. from the tube back into the drug cartridge), the valve will remain closed stopping this flow.
In some embodiments, the plunger of the cartridge interacts with a drive nut of the pump (located in a pump chamber of a pump). As disclosed elsewhere herein, a cartridge connector attached to the cartridge may act to prevent inadvertent lift-off of the plunger from the drive nut. For example, in some embodiments, the check valve prevents the plunger from moving and distributing medicament in an uncontrolled and/or undesired way. For instance, medicament vials having plungers are typically designed to have little or no resistance and/or friction between the plunger and the wall of the reservoir. Thus, the plunger can move and distribute medicament with very little force applied to the plunger (e.g., even by moving the cartridge). In some embodiments, configurations described herein avoid issues with low friction plungers by using a check valve.
Charger
In some embodiments, the pump contains an internal inductively chargeable battery. In some embodiments, the pump battery is not replaceable. In some embodiments, the pump is water resistant (up to 5 m, 10 m, 20 m, 50 m, or ranges including and/or spanning the aforementioned values) or water proof. In some embodiments, the pump is charged using an inductive charging pad/cradle and USB cable (as shown in
Although the charging station 700 is described as capable of wirelessly charging the ambulatory medicament device 100, in some cases, the charging station 700 may charge the battery of the ambulatory medicament device 100 via a wired connection, such as a
In some embodiments, to recharge your pump, one or more of the following steps can be performed: connect the wireless charging pad to the wall power outlet using the provided micro USB cable and plug, place the pump onto the supplied inductive charging pad, verify the touchscreen and the charging pad indicate that the pump is charging, and charge the pump with the supplied charging pad and cables.
In some embodiments, when placed on the charger, the touchscreen turns on and illuminates. In some embodiments, the touchscreen displays the state of charge and/or indicates that the pump is charging. In some embodiments, the light on the charging pad illuminates continuously while charging and blinks when it detects the presence of a pump but is not charging. In some embodiments, the pump indicates it is not charging and is not fully charged when the charging pad is blinking. In some embodiments, if the pump is not charging, the user can verify that the pump is properly aligned over the charging pad. In some embodiments, the typical time to fully charge a depleted battery is equal to or less than about 2 hours, 4 hours, or ranges including and/or spanning the aforementioned values.
In some embodiments, it may be beneficial to minimize the amount of time when the pump is without power. In some embodiments, when pump has no power, it will not be dosing insulin or providing the user with continuous glucose monitoring CGM values. In some embodiments, when the pump has run out of power, the Sleep/Wake button will not turn the screen on or off.
In some embodiments, for optimum battery life, it is recommended that you recharge the battery daily, regardless of what the battery level is reported as on the screen. In some embodiments, a fully charged battery can run several days for a typical user, but is dependent on amount of usage, especially of the backlight and volume of insulin delivered. In some embodiments, the user should monitor the battery charge level and alarms to determine what is a typical battery life for the user. In some embodiments, the user should recharge the pump according to typical usage.
In some embodiments, the system includes a wireless charging interface that conforms to a Qi standard. In some embodiments, the wireless charging include Rezence (from the AirFuel Alliance) and Open Dots (from the Open Dots Alliance).
Certain embodiments may comprise the following specifications:
Point of Care Cartridge Filling
In some embodiments (as in
Some embodiments, pertain to a method and components used to fill a vial at a point of care (e.g., by a doctor, nurse, or patient). In some embodiments, as shown in
In some embodiments, as shown in
In some embodiments, as disclosed herein, the pushrod can be connected directly to the plunger by means of a threads and, upon completion of the filling procedure, the pushrod can be disconnected and discarded (or reused), leaving the elastomeric plunger. In some embodiments, the threads could have a uni-directional burred surface (not shown) that would allow it to easily thread into the elastomeric plunger, but would resist being threaded out of the elastomeric plunger. In some embodiments, the pushrod has a thread-locking barb (not shown). In some embodiments, the pushrod and transfer hub are disposed of in a biohazard container as shown in
O-Ring in Pump
As disclosed elsewhere herein, one general aspect includes an infusion pump (e.g., an infusion pump apparatus), the pump including a housing having an interior space. The infusion pump apparatus also includes a bore through said housing, said bore having a first end and a second end, and the bore configured to receive a medicament cartridge (e.g., a receptacle). In some embodiments, the infusion pump apparatus also includes where the first end defines an opening into said housing and the second end is located in the interior space of the housing. In some embodiments, the infusion pump apparatus also includes an elongate shaft disposed in the bore and configured to engage the medicament cartridge. In some embodiments, the infusion pump apparatus also includes an O-ring circumferentially disposed on the elongate shaft adjacent to the second end of the bore.
Implementations may include one or more of the following features. In some embodiments, the O-ring forms a barrier to water and debris from entering the interior space of the housing. In some embodiments, a position of the O-ring is configured to permit water or air movement around the medicament cartridge. In some embodiments, the O-ring is configured to permit pressure differential equalization between an infusion site and drug cartridge. In some embodiments, the O-ring exerts pressure on the elongated shaft when the O-ring is circumferentially disposed on the elongated shaft. In some embodiments, the O-ring further includes a lubricant to lubricate between the elongated shaft to reduce friction around between the O-ring and the elongated shaft.
In some embodiments, the O-ring is configured to maintain a pressure differential between ambient pressure and the interior space of the housing. In some embodiments, the O-ring is configured to maintain a pressure differential between the interior space of the housing and an interior of the bore. In some embodiments, the bore is configured to be exposed to an ambient pressure and equalize the ambient pressure. In some embodiments, the bore is configured to be exposed to an ambient pressure and equalize to the ambient pressure around the medicament cartridge. In some embodiments, the O-ring is compression fit over the on the elongate shaft is configured to create a barrier to water and air ingress into the interior space of the housing.
Infusion pumps may be adapted for implantation directly into the body of a patient. In some embodiments, the pump may be programmable to deliver a desired medicament from a cartridge directly to an infusion site based on various variables. Pressure differential, as well as permeation of air, water and debris particulates in the pump housing, may be advantageously managed by positioning an O-ring on the elongate shaft engaging the medicament cartridge. Accordingly, in an exemplary embodiment, an infusion pump apparatus comprises a housing and a bore through said housing. In some embodiments, the bore has a first end and a second end and is configured to receive a medicament cartridge. In some embodiments, the first end of the bore defines an opening into said housing. In some embodiments, the second end of the bore is located in the interior space of the housing. In some embodiments, an elongate shaft is disposed in the bore and configured to engage the medicament cartridge in the bore. In some embodiments, an O-ring is circumferentially disposed on the elongate shaft adjacent to the second end of the bore. In other embodiments, an elongate shaft disposed in the bore and configured to engage the medicament cartridge and an O-ring circumferentially disposed on the elongate shaft adjacent to the second end of the bore.
Various embodiments include an IPX (water/dirt ingress) boundary sealing O-ring for an ambulatory medical device that has been designed in such a way to allow a drug cartridge to match the atmospheric pressure of the patient line and infusion site. In some embodiments, the IPX rating is greater than or equal to 1, 2, 3, 4, 5, 6, 7, 8, or ranges including and/or spanning the aforementioned values. In some embodiments, differences in atmospheric pressures between the infusion site and drug cartridge can lead to under/over delivery of a medicament. The drug cartridge chamber in the ambulatory medical device allows air and water to pass freely around the drug cartridges. This boundary choice requires the design drug cartridge chamber and drug cartridge to be impervious to the effects of the environment. The present disclosure uses some sort of sealing mechanism that prevents water from infiltrating the cartridge area, but still, allow air to move through the seal to equalize the pressure differential between the infusion site and drug cartridge. Typical designs that seal against the disposable device use O-rings to seal the pump surface to a flat surface on the disposable. One disadvantage of the previously mentioned design is that the sealing surface of the O-ring is exposed to the environment during set changes and can allow contamination to accumulate on the sealing surface of the O-ring causing the failure of the O-ring to provide adequate IPX sealing of the device. This can lead to seal failure and the ingress of water and fluids into the drug cartridge. The advantages of choosing the IPX seal boundary to not encompass allows the removal of the hydrophobic filter mechanism, as it is no longer needed. Water and air can freely move around the cartridge equalizing pressures. The O-ring seal thus provides the IPX seal to the device, preventing water and dirt from entering the electronic and motor/gear train enclosure. In some embodiments, the O-ring application around the lead screw nut provides a smooth continuous surface for sealing and prevents exposure of the sealing surface to environmental contaminants. In some embodiments, the wiping action of the O-ring against the lead screw nut prevents water and dust ingress into the enclosure and provides for a durable seal.
In the exemplary embodiments, the infusion pump apparatus comprises a housing for various components. The housing can essentially take any shape suitable for receiving a medicament cartridge and incorporating components for dispensing the medicament from the cartridge. An exemplary infusion pump is provided in
In some embodiments, the infusion pump apparatuses of the exemplary embodiments may have one or more bores configured to receive a medicament cartridge. In general, the bores are cylindrical but may have any shape or modified features such as grooves or slots to receive features of a medicament cartridge as well as other components of the apparatus.
As shown in
As shown in
In some embodiments, the O-rings may be formed from any material suitable for achieving a seal and have different shape or thickness. In an exemplary embodiment, the O-ring for the elongate shaft comprises a polymeric material. Moreover, the O-rings can be of different sizes as exemplified in
As shown in
In an exemplary embodiment, the O-ring seal exerts pressure on the elongated shaft when the O-ring is circumferentially disposed on the elongated shaft. A lubricant may be included to lubricate the elongated shaft to reduce the friction between the O-ring and the elongated shaft.
A non-limiting working example of an exemplary embodiment is provided in
The features of the exemplary embodiments described in this disclosure provide various advantages. First, the O-ring seal around the elongate shaft forms a barrier to water and debris entering the interior space of the housing. This can prevent interference with the mechanical action of the pump and avoid potentially dispensing an incorrect amount of medicament.
Additionally, the position of the O-ring near the second end of the elongate shaft permits water or air movement around the cartridge whereby the pressure differential between the infusion site and the medicament cartridge is equalized.
Yet another advantage of the exemplary embodiments is that the infusion pump does not utilize an O-ring to seal the junction between the infusion set and the top of the medicament cartridge. In particular, the O-ring is not placed adjacent to the opening to the pump housing. This allows for a design which does not require a hydrophobic filter, as such filters become plugged, thereby affecting the pressure inside the pump housing. Moreover, a permanent installed hydrophobic filter would unlikely be able to last the full warranty period of the device, which forces the filter and complexity to be added to the disposable device which raises the costs and complexity on the disposable device.
The use of an O-ring as described can result in the pump apparatus being configured to maintain a pressure differential between the ambient pressure and the interior of the housing. Moreover, the pump apparatus can be configured to maintain a pressure differential between the interior of the housing and an interior of the bore.
Yet another advantage is that the Bore is configured to be exposed to the ambient pressure and equalize the ambient pressure around the medicament cartridge. Thus, a seal at the bore first opening is not required. Finally, the wiping action of the O-ring against the lead screw nut prevents water and dust ingress into the enclosure and provides a durable seal.
Example Methods and User Interfaces
An example pump can include a pump controller configured to implement one or more of the methods or user interfaces described herein. The pump can include a touchscreen that displays content and controls and accepts user input in the form of touches, taps, and/or other gestures. Certain example user interfaces that implement certain functions will be described herein; alternative user interfaces that accomplish the functions described herein and alternative or additional functions are possible. In some embodiments, a pump implements one, more than one, or all of the user interfaces, functionalities, and/or methods described herein.
A pump 100 can include a touchscreen 111 (see
The sleep/wake button can be or include a capacitive touch interface that is positioned in a portion of the pump housing that is recessed from the area immediately surrounding the button. The button can have no external seams, thereby allowing the pump housing to have an uninterrupted surface in the vicinity of the button that is, for example, impervious to ingress of water into the housing. The button can be configured to sense a proximity or touch of a finger on or near a contact surface of the button (a “user touch”). In response sensing a user touch, a controller connected to the button 1006 can generate a command to cause the touchscreen to toggle on or off. In response to sensing a user touch that has a duration of at least 3 seconds (a “user touch and hold”), the controller can generate a command to turn on or toggle a backlight configured to illuminate the touchscreen.
The insulin cartridge port holds an insulin cartridge that can include an insulin cartridge connector for connecting the cartridge to an insulin tubing set leading to a dosing site. The glucagon cartridge port can include a chamber cover in the event that a glucagon cartridge is not installed. When the glucagon cartridge is installed, it can include a glucagon cartridge connector for connecting the cartridge to a glucagon tubing set leading to a dosing site that can be different from the insulin dosing site.
The pump can include a regulatory label and a device identifier.
Methods and user interfaces can be implemented by a pump controller connected to a touchscreen, including an example method for starting a pump, such as the pump. The starting method can be initiated, for example, when the user first charges the pump. In some embodiments, when a user places the pump on a charging pad for the first time, the touchscreen of the pump turns on, and a pump controller generates one or more displays that guide the user through the starting method.
The pump receives user input indicating that the starting method should be initiated. The pump receives a selection of a preferred language. The pump receives a device identifier selected by the user. The pump can receive confirmation or user selection of a current time. The pump can receive confirmation or user selection of a current date.
Methods and user interfaces can be implemented by a pump controller connected to a touchscreen, including: setting up a pump, such as the pump, to begin therapy of a subject; setting up a continuous glucose monitor (CGM); setting up or changing an insulin cartridge; setting up or changing an infusion site; and setting up a subject model including the weight of the subject and/or a parameter based on the weight of the subject.
Listing of user interfaces can be implemented by a pump controller connected to a touchscreen.
Methods and user interfaces can be implemented by a pump controller connected to a touchscreen, including: operation of a sleep/wake button, display of an unlock screen on a touchscreen, unlocking of a pump, display of a home screen on a touchscreen, and charging of a pump.
Methods and user interfaces can be implemented by a pump controller connected to a touchscreen, including: setting up a CGM; displaying information about a CGM session; setting CGM alerts; displaying CGM trends, values, and graphs; displaying CGM data and insulin delivery data; and displaying CGM communication status information.
Methods and user interfaces can be implemented by a pump controller connected to a touchscreen, including: changing an insulin cartridge, filling tubing, and changing an infusion site.
Methods and user interfaces can be implemented by a pump controller connected to a touchscreen, including: displaying a home screen; receiving blood glucose values measured by a blood glucose meter other than a CGM; pausing and resuming insulin delivery; receiving a selection of a volume level for alerts and other notifications; pairing a mobile electronic device to the pump; adjusting pump settings for therapy, time and date, device identifier, CGM alerts, and device power; adjusting clinical settings using a secret code; and displaying device history.
Methods and user interfaces can be implemented by a pump controller connected to a touchscreen, including receiving a meal announcement from a user.
At least some of the example methods and user interfaces can be implemented by a pump controller connected to memory that contains computer program instructions (grouped as modules or components in some embodiments) that a hardware processor can execute in order to implement one or more embodiments described herein. The memory can generally include RAM, ROM and/or other persistent, auxiliary or non-transitory computer-readable media. The memory can store an operating system that provides computer program instructions for use by the hardware processor in the general administration and operation of a pump, such as the pump described herein.
Terminology
Depending on the embodiment, certain acts, events, or functions of any of the processes or algorithms described herein can be performed in a different sequence, can be added, merged, or left out altogether (e.g., not all described operations or events are necessary for the practice of the algorithm). Moreover, in certain embodiments, operations or events can be performed concurrently, e.g., through multi-threaded processing, interrupt processing, or multiple processors or processor cores or on other parallel architectures, rather than sequentially.
The various illustrative logical blocks, modules, routines, user interfaces, and algorithm steps described in connection with the embodiments disclosed herein can be implemented as electronic hardware, or combinations of electronic hardware and computer software. To clearly illustrate this interchangeability, various illustrative components, blocks, modules, and steps have been described above generally in terms of their functionality. Whether such functionality is implemented as hardware, or as software that runs on hardware, depends upon the particular application and design constraints imposed on the overall system. The described functionality can be implemented in varying ways for each particular application, but such implementation decisions should not be interpreted as causing a departure from the scope of the disclosure.
Moreover, the various illustrative logical blocks, user interfaces, and modules described in connection with the embodiments disclosed herein can be implemented or performed by a machine, such as a general purpose processor device, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA) or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein. A processor device can be a microprocessor, but in the alternative, the processor device can be a controller, microcontroller, or state machine, combinations of the same, or the like. A processor device can include electrical circuitry configured to process computer-executable instructions. In another embodiment, a processor device includes an FPGA or other programmable device that performs logic operations without processing computer-executable instructions. A processor device can also be implemented as a combination of computing devices, e.g., a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration. Although described herein primarily with respect to digital technology, a processor device may also include primarily analog components. For example, some or all of the algorithms described herein may be implemented in analog circuitry or mixed analog and digital circuitry. A computing environment can include any type of computer system, including, but not limited to, a computer system based on a microprocessor, a mainframe computer, a digital signal processor, a portable computing device, a device controller, or a computational engine within an appliance, to name a few.
The elements of a method, process, routine, or algorithm described in connection with the embodiments disclosed herein can be embodied directly in hardware, in a software module executed by a processor device, or in a combination of the two. A software module can reside in RAM memory, flash memory, ROM memory, EPROM memory, EEPROM memory, registers, hard disk, a removable disk, a CD-ROM, or any other form of a non-transitory computer-readable storage medium. An exemplary storage medium can be coupled to the processor device such that the processor device can read information from, and write information to, the storage medium. In the alternative, the storage medium can be integral to the processor device. The processor device and the storage medium can reside in an ASIC. The ASIC can reside in a user terminal. In the alternative, the processor device and the storage medium can reside as discrete components in a user terminal.
Language of example or capability used herein, such as, among others, “can,” “could,” “might,” “may,” “e.g.,” “some,” “certain,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements and/or steps. Thus, such conditional language is not generally intended to imply that features, elements and/or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without other input or prompting, whether these features, elements and/or steps are included or are to be performed in any particular embodiment. The terms “comprising,” “including,” “having,” and the like are synonymous and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and so forth. Also, the term “or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term “or” means one, some, or all of the elements in the list.
Disjunctive language such as the phrase “at least one of X, Y, Z,” unless specifically stated otherwise, is otherwise understood with the context as used in general to present that an item, term, etc., may be either X, Y, or Z, or any combination thereof (e.g., X, Y, and/or Z). Thus, such disjunctive language is not generally intended to, and should not, imply that certain embodiments require at least one of X, at least one of Y, or at least one of Z to each be present.
Unless otherwise explicitly stated, articles such as “a” or “an” should generally be interpreted to include one or more described items. Accordingly, phrases such as “a device configured to” are intended to include one or more recited devices. Such one or more recited devices can also be collectively configured to carry out the stated recitations. For example, “a processor configured to carry out recitations A, B and C” can include a first processor configured to carry out recitation A working in conjunction with a second processor configured to carry out recitations B and C.
Many variations may be made to the embodiments described herein. All variations are intended to be included within the scope of this disclosure. The description of the embodiments herein can be practiced in many ways. Any terminology used herein should not be construed as restricting the features or aspects of the disclosed subject matter. The scope should instead be construed in accordance with the appended claims.
This invention was made with U.S. Government support under Contract No. DK120234, awarded by the National Institutes of Health. The Government has certain rights in the invention.
| Number | Name | Date | Kind |
|---|---|---|---|
| 1930929 | Eisenberg | Oct 1933 | A |
| 3807467 | Tascher et al. | Apr 1974 | A |
| 4150673 | Watt | Apr 1979 | A |
| 4253501 | Ogle | Mar 1981 | A |
| 4515584 | Abe et al. | May 1985 | A |
| 4585439 | Michel | Apr 1986 | A |
| 4608042 | Vanderveen | Aug 1986 | A |
| 4675006 | Hrushesky | Jun 1987 | A |
| 4955861 | Enegren et al. | Sep 1990 | A |
| 5085643 | Larkin et al. | Feb 1992 | A |
| 5147323 | Haber | Sep 1992 | A |
| 5243982 | Mostl | Sep 1993 | A |
| 5298023 | Haber | Mar 1994 | A |
| 5356380 | Hoekwater et al. | Oct 1994 | A |
| 5411480 | Kriesel | May 1995 | A |
| 5472403 | Cornacchia | Dec 1995 | A |
| 5505704 | Pawelka et al. | Apr 1996 | A |
| 5522803 | Teissen-Simony | Jun 1996 | A |
| 5529463 | Layer | Jun 1996 | A |
| 5545152 | Funderburk | Aug 1996 | A |
| 5616124 | Hague et al. | Apr 1997 | A |
| 5916494 | Widman et al. | Jun 1999 | A |
| 5954697 | Srisathapat et al. | Sep 1999 | A |
| 5961494 | Hogan | Oct 1999 | A |
| 5971972 | Rosenbaum | Oct 1999 | A |
| 6106498 | Friedli et al. | Aug 2000 | A |
| 6132416 | Broselow | Oct 2000 | A |
| 6248067 | Causey, III et al. | Jun 2001 | B1 |
| 6259587 | Sheldon et al. | Jul 2001 | B1 |
| 6360784 | Philippens et al. | Mar 2002 | B1 |
| 6362591 | Moberg | Mar 2002 | B1 |
| 6368314 | Kipfer et al. | Apr 2002 | B1 |
| 6390130 | Guala | May 2002 | B1 |
| 6485465 | Moberg et al. | Nov 2002 | B2 |
| 6551276 | Mann et al. | Apr 2003 | B1 |
| 6551298 | Zhang et al. | Apr 2003 | B1 |
| 6554798 | Mann et al. | Apr 2003 | B1 |
| 6555986 | Moberg | Apr 2003 | B2 |
| 6558320 | Causey, III et al. | May 2003 | B1 |
| 6572545 | Knobbe et al. | Jun 2003 | B2 |
| 6585695 | Adair et al. | Jul 2003 | B1 |
| 6620138 | Marrgi et al. | Sep 2003 | B1 |
| 6641533 | Causey, III et al. | Nov 2003 | B2 |
| 6652483 | Slate | Nov 2003 | B2 |
| 6656148 | Das et al. | Dec 2003 | B2 |
| 6659980 | Moberg et al. | Dec 2003 | B2 |
| 6719728 | Mason et al. | Apr 2004 | B2 |
| 6736797 | Larsen et al. | May 2004 | B1 |
| 6752787 | Causey, III et al. | Jun 2004 | B1 |
| 6801420 | Talbot et al. | Oct 2004 | B2 |
| 6809653 | Mann et al. | Oct 2004 | B1 |
| 6811534 | Bowman et al. | Nov 2004 | B2 |
| 6821421 | Murakami | Nov 2004 | B2 |
| 6854620 | Ramey | Feb 2005 | B2 |
| 6872200 | Mann et al. | Mar 2005 | B2 |
| 6878132 | Kipfer | Apr 2005 | B2 |
| 6936029 | Mann et al. | Aug 2005 | B2 |
| 6939329 | Verkaart | Sep 2005 | B1 |
| 6958705 | Lebel et al. | Oct 2005 | B2 |
| 6960198 | Sarmiento | Nov 2005 | B2 |
| 6979326 | Mann et al. | Dec 2005 | B2 |
| 6997920 | Mann et al. | Feb 2006 | B2 |
| 7025226 | Ramey | Apr 2006 | B2 |
| 7025743 | Mann et al. | Apr 2006 | B2 |
| 7098803 | Mann et al. | Aug 2006 | B2 |
| 7109878 | Mann et al. | Sep 2006 | B2 |
| 7187528 | Talbot et al. | Mar 2007 | B2 |
| 7193521 | Moberg et al. | Mar 2007 | B2 |
| 7281314 | Hess et al. | Oct 2007 | B2 |
| 7285105 | Kim et al. | Oct 2007 | B2 |
| 7291133 | Kindler et al. | Nov 2007 | B1 |
| 7324012 | Mann et al. | Jan 2008 | B2 |
| 7342508 | Morgan et al. | Mar 2008 | B2 |
| 7460350 | Talbot et al. | Dec 2008 | B2 |
| 7534226 | Mernoe et al. | May 2009 | B2 |
| 7602310 | Mann et al. | Oct 2009 | B2 |
| 7621893 | Moberg et al. | Nov 2009 | B2 |
| 7625354 | Hochman | Dec 2009 | B2 |
| 7628772 | McConnell et al. | Dec 2009 | B2 |
| 7628782 | Adair et al. | Dec 2009 | B2 |
| 7648494 | Kornerup et al. | Jan 2010 | B2 |
| 7654127 | Krulevitch et al. | Feb 2010 | B2 |
| 7655618 | Green et al. | Feb 2010 | B2 |
| 7658734 | Adair et al. | Feb 2010 | B2 |
| 7678762 | Green et al. | Mar 2010 | B2 |
| 7678763 | Green et al. | Mar 2010 | B2 |
| 7683027 | Green et al. | Mar 2010 | B2 |
| 7708717 | Estes et al. | May 2010 | B2 |
| 7749185 | Wilson | Jul 2010 | B2 |
| 7760481 | Talbot et al. | Jul 2010 | B2 |
| 7766873 | Moberg et al. | Aug 2010 | B2 |
| 7776030 | Estes et al. | Aug 2010 | B2 |
| 7789859 | Estes et al. | Sep 2010 | B2 |
| 7794427 | Estes et al. | Sep 2010 | B2 |
| 7794428 | Estes et al. | Sep 2010 | B2 |
| 7815602 | Mann et al. | Oct 2010 | B2 |
| 7819843 | Mann et al. | Oct 2010 | B2 |
| 7831310 | Lebel et al. | Nov 2010 | B2 |
| 7833196 | Estes et al. | Nov 2010 | B2 |
| 7879010 | Hunn et al. | Feb 2011 | B2 |
| 7879026 | Estes et al. | Feb 2011 | B2 |
| 7887512 | Estes et al. | Feb 2011 | B2 |
| 7892206 | Moberg et al. | Feb 2011 | B2 |
| 7914449 | Kouchi et al. | Mar 2011 | B2 |
| 7922708 | Estes et al. | Apr 2011 | B2 |
| 7951112 | Patzer | May 2011 | B2 |
| 7967785 | Morgan et al. | Jun 2011 | B2 |
| 7981084 | Estes et al. | Jul 2011 | B2 |
| 7981105 | Adair et al. | Jul 2011 | B2 |
| 7988683 | Adair et al. | Aug 2011 | B2 |
| 7998111 | Moberg et al. | Aug 2011 | B2 |
| 7998131 | Adair et al. | Aug 2011 | B2 |
| 8004422 | Hess et al. | Aug 2011 | B2 |
| 7938803 | Mernoe et al. | Oct 2011 | B2 |
| 8034026 | Grant et al. | Oct 2011 | B2 |
| 8057436 | Causey et al. | Nov 2011 | B2 |
| 8062257 | Moberg et al. | Nov 2011 | B2 |
| 8065096 | Moberg et al. | Nov 2011 | B2 |
| 8088096 | Lauchard et al. | Jan 2012 | B2 |
| 8105279 | Mernoe et al. | Jan 2012 | B2 |
| 8106534 | Spurlin et al. | Jan 2012 | B2 |
| 8142397 | Patzer | Mar 2012 | B2 |
| 8167846 | Chong et al. | May 2012 | B2 |
| 8177767 | Kristensen et al. | May 2012 | B2 |
| 8182447 | Moberg et al. | May 2012 | B2 |
| 8192394 | Estes et al. | Jun 2012 | B2 |
| 8197444 | Bazargan et al. | Jun 2012 | B1 |
| 8206350 | Mann et al. | Jun 2012 | B2 |
| 8206353 | Chong et al. | Jun 2012 | B2 |
| 8211059 | Kriesel | Jul 2012 | B2 |
| 8211062 | Estes et al. | Jul 2012 | B2 |
| 8251959 | Johner et al. | Aug 2012 | B2 |
| 8257345 | Adair et al. | Sep 2012 | B2 |
| 8267893 | Moberg et al. | Sep 2012 | B2 |
| 8273061 | McConnell et al. | Sep 2012 | B2 |
| 8282601 | Mernoe et al. | Oct 2012 | B2 |
| 8287495 | Michaud et al. | Oct 2012 | B2 |
| 8287516 | Kornerup et al. | Oct 2012 | B2 |
| 8298184 | DiPerna et al. | Oct 2012 | B2 |
| 8303572 | Adair et al. | Nov 2012 | B2 |
| 8372039 | Mernoe et al. | Feb 2013 | B2 |
| 8409142 | Causey et al. | Apr 2013 | B2 |
| 8430847 | Mernoe et al. | Apr 2013 | B2 |
| 8430849 | Smith et al. | Apr 2013 | B2 |
| 8454575 | Estes et al. | Jun 2013 | B2 |
| 8469942 | Kow et al. | Jun 2013 | B2 |
| 8475408 | Mernoe et al. | Jul 2013 | B2 |
| 8480623 | Mernoe et al. | Jul 2013 | B2 |
| 8483980 | Moberg et al. | Jul 2013 | B2 |
| 8500716 | Adair et al. | Aug 2013 | B2 |
| 8512276 | Talbot et al. | Aug 2013 | B2 |
| 8512289 | Chong et al. | Aug 2013 | B2 |
| 8523803 | Favreau | Sep 2013 | B1 |
| 8551045 | Sie et al. | Oct 2013 | B2 |
| 8551046 | Causey et al. | Oct 2013 | B2 |
| 8556856 | Bazargan et al. | Oct 2013 | B2 |
| 8556866 | Krulevitch et al. | Oct 2013 | B2 |
| 8562565 | Fonacier et al. | Oct 2013 | B2 |
| 8562587 | Kovatchev et al. | Oct 2013 | B2 |
| 8568349 | Shergold | Oct 2013 | B2 |
| 8573027 | Rosinko et al. | Nov 2013 | B2 |
| 8579813 | Causey, III et al. | Nov 2013 | B2 |
| 8597269 | Chong et al. | Dec 2013 | B2 |
| 8603026 | Favreau | Dec 2013 | B2 |
| 8603027 | Favreau | Dec 2013 | B2 |
| 8603033 | Bazargan et al. | Dec 2013 | B2 |
| 8613726 | Causey, III et al. | Dec 2013 | B2 |
| 8613731 | Hansen et al. | Dec 2013 | B2 |
| 8617110 | Moberg et al. | Dec 2013 | B2 |
| 8622966 | Causey, III et al. | Jan 2014 | B2 |
| 8628510 | Bazargan et al. | Jan 2014 | B2 |
| 8641671 | Michaud et al. | Feb 2014 | B2 |
| 8647074 | Moberg et al. | Feb 2014 | B2 |
| 8647296 | Moberg et al. | Feb 2014 | B2 |
| 8663103 | Causey, III et al. | Mar 2014 | B2 |
| 8674288 | Hanson et al. | Mar 2014 | B2 |
| 8679060 | Mernoe et al. | Mar 2014 | B2 |
| 8681010 | Moberg et al. | Mar 2014 | B2 |
| 8696633 | Estes et al. | Apr 2014 | B2 |
| 8747368 | Mernoe et al. | Jun 2014 | B2 |
| 8747369 | Mernoe et al. | Jun 2014 | B2 |
| 8758323 | Michaud et al. | Jun 2014 | B2 |
| 8771229 | Amirouche et al. | Jul 2014 | B2 |
| 8777901 | Smith et al. | Jul 2014 | B2 |
| 8790307 | Amirouche et al. | Jul 2014 | B2 |
| 8821442 | Haaar | Sep 2014 | B2 |
| 8823528 | Blomquist | Sep 2014 | B2 |
| 8834420 | Estes et al. | Sep 2014 | B2 |
| 8841012 | Fonacier et al. | Sep 2014 | B2 |
| 8864726 | Halili et al. | Oct 2014 | B2 |
| 8864737 | Hasegawa et al. | Oct 2014 | B2 |
| 8864739 | Moberg et al. | Oct 2014 | B2 |
| 8870829 | Halili et al. | Oct 2014 | B2 |
| 8876770 | Kraft et al. | Nov 2014 | B2 |
| 8900206 | Halili et al. | Dec 2014 | B2 |
| 8905972 | Smith et al. | Dec 2014 | B2 |
| 8915879 | Smith et al. | Dec 2014 | B2 |
| 8936573 | Blomquist | Jan 2015 | B2 |
| 8945068 | Halili et al. | Feb 2015 | B2 |
| 8974435 | Friedl | Mar 2015 | B2 |
| 8992475 | Mann et al. | Mar 2015 | B2 |
| 8992507 | Aeschlimann et al. | Mar 2015 | B2 |
| 8998840 | Hanson et al. | Apr 2015 | B2 |
| 8998842 | Lauchard et al. | Apr 2015 | B2 |
| 8998856 | Eggert | Apr 2015 | B2 |
| 8998858 | Chong et al. | Apr 2015 | B2 |
| 9011371 | Moberg et al. | Apr 2015 | B2 |
| 9033925 | Moberg et al. | May 2015 | B2 |
| 9033951 | Kow et al. | May 2015 | B2 |
| 9050406 | Kow et al. | Jun 2015 | B2 |
| 9101710 | Yavorsky et al. | Aug 2015 | B2 |
| 9101715 | Causey, III et al. | Aug 2015 | B2 |
| 9107999 | Moberg et al. | Aug 2015 | B2 |
| 9114209 | Estes et al. | Aug 2015 | B2 |
| 9114213 | Murakami et al. | Aug 2015 | B2 |
| 9119917 | Blomquist | Sep 2015 | B2 |
| 9132228 | Yan | Sep 2015 | B2 |
| 9173998 | Rosinko et al. | Nov 2015 | B2 |
| 9180242 | Metzmaker et al. | Nov 2015 | B2 |
| 9180243 | Michaud | Nov 2015 | B2 |
| 9180254 | Avery | Nov 2015 | B2 |
| 9184490 | Crouther et al. | Nov 2015 | B2 |
| 9194388 | Laermer | Nov 2015 | B2 |
| 9205192 | Estes et al. | Dec 2015 | B2 |
| 9211376 | Kouyoumjian et al. | Dec 2015 | B2 |
| 9211377 | DiPerna et al. | Dec 2015 | B2 |
| 9216249 | Smith et al. | Dec 2015 | B2 |
| 9220835 | Cane | Dec 2015 | B2 |
| 9250106 | Rosinko et al. | Feb 2016 | B2 |
| 9272009 | Spencer | Mar 2016 | B2 |
| 9283318 | Yavorsky et al. | Mar 2016 | B2 |
| 9295826 | Bertrand et al. | Mar 2016 | B2 |
| 9308320 | Smith et al. | Apr 2016 | B2 |
| 9308321 | Alderete et al. | Apr 2016 | B2 |
| 9314569 | Causey et al. | Apr 2016 | B2 |
| 9320849 | Smith et al. | Apr 2016 | B2 |
| 9327073 | Moberg et al. | May 2016 | B2 |
| 9335910 | Farnan et al. | May 2016 | B2 |
| 9339639 | Halili et al. | May 2016 | B2 |
| 9344024 | Favreau | May 2016 | B2 |
| 9345643 | Okiyama | May 2016 | B2 |
| 9364608 | Moberg et al. | Jun 2016 | B2 |
| 9379652 | Favreau | Jun 2016 | B2 |
| 9379653 | Favreau | Jun 2016 | B2 |
| 9381297 | Brown et al. | Jul 2016 | B2 |
| 9381300 | Smith et al. | Jul 2016 | B2 |
| 9393399 | Yavorsky et al. | Jul 2016 | B2 |
| 9415157 | Mann et al. | Aug 2016 | B2 |
| 9427519 | Kraft et al. | Aug 2016 | B2 |
| 9433731 | Trock et al. | Sep 2016 | B2 |
| 9433732 | Moberg et al. | Sep 2016 | B2 |
| 9433733 | Moberg et al. | Sep 2016 | B2 |
| 9452255 | Tieck et al. | Sep 2016 | B2 |
| 9452256 | Tieck et al. | Sep 2016 | B2 |
| 9463309 | Yavorsky et al. | Oct 2016 | B2 |
| 9494147 | Chong et al. | Nov 2016 | B2 |
| 9498573 | Smith et al. | Nov 2016 | B2 |
| 9514518 | Gillespie et al. | Dec 2016 | B2 |
| 9517299 | Tieck et al. | Dec 2016 | B2 |
| 9517301 | Estes et al. | Dec 2016 | B2 |
| 9533132 | Halili et al. | Jan 2017 | B2 |
| 9539385 | Mathys | Jan 2017 | B2 |
| 9539388 | Causey et al. | Jan 2017 | B2 |
| 9554967 | Mola et al. | Jan 2017 | B2 |
| 9579452 | Adair et al. | Feb 2017 | B2 |
| 9592339 | Zhou | Mar 2017 | B2 |
| 9597462 | Moore | Mar 2017 | B2 |
| 9610431 | Halili et al. | Apr 2017 | B2 |
| 9629992 | Halili et al. | Apr 2017 | B2 |
| 9636453 | Monirabbasi et al. | May 2017 | B2 |
| 9682189 | Good et al. | Jun 2017 | B2 |
| 9687612 | Avery et al. | Jun 2017 | B2 |
| 9707339 | Chartrand | Jul 2017 | B2 |
| 9715327 | Rosinko et al. | Jul 2017 | B2 |
| 9717845 | Istoc | Aug 2017 | B2 |
| 9717848 | Geismar et al. | Aug 2017 | B2 |
| 9731067 | Pananen | Aug 2017 | B2 |
| 9744290 | Tieck et al. | Aug 2017 | B2 |
| 9744291 | Tieck et al. | Aug 2017 | B2 |
| 9744301 | Mann et al. | Aug 2017 | B2 |
| 9750871 | Metzmaker et al. | Sep 2017 | B2 |
| 9750873 | Brown et al. | Sep 2017 | B2 |
| 9750875 | Smith et al. | Sep 2017 | B2 |
| 9770553 | Bazargan et al. | Sep 2017 | B2 |
| 9782536 | Skutnik et al. | Oct 2017 | B2 |
| 9782543 | Groeschke et al. | Oct 2017 | B2 |
| 9789245 | Tieck et al. | Oct 2017 | B2 |
| 9795732 | Trock et al. | Oct 2017 | B2 |
| 9801787 | Py | Oct 2017 | B2 |
| 9814830 | Mernoe et al. | Nov 2017 | B2 |
| 9814872 | Eggert et al. | Nov 2017 | B2 |
| 9839741 | Yavorsky et al. | Dec 2017 | B2 |
| 9841014 | Yap et al. | Dec 2017 | B2 |
| 9863837 | Rule et al. | Jan 2018 | B2 |
| 9872957 | Causey et al. | Jan 2018 | B2 |
| 9883834 | Amirouche et al. | Feb 2018 | B2 |
| 9889256 | Cabiri et al. | Feb 2018 | B2 |
| 9895490 | Kow et al. | Feb 2018 | B2 |
| 9925330 | Tieck et al. | Mar 2018 | B2 |
| 9931459 | Tieck et al. | Apr 2018 | B2 |
| 9931460 | Tieck et al. | Apr 2018 | B2 |
| 9943645 | Monirabbasi et al. | Apr 2018 | B2 |
| 9950113 | Franke et al. | Apr 2018 | B2 |
| 9987420 | Pananen | Jun 2018 | B2 |
| 9993592 | Amirouche et al. | Jun 2018 | B2 |
| 9993594 | Bazargan et al. | Jun 2018 | B2 |
| 10010674 | Rosinko et al. | Jul 2018 | B2 |
| 10010678 | Schildt et al. | Jul 2018 | B2 |
| 10016564 | Piehl et al. | Jul 2018 | B2 |
| 10029045 | Smith et al. | Jul 2018 | B2 |
| 10064993 | Mernoe et al. | Sep 2018 | B2 |
| 10071200 | Alderete et al. | Sep 2018 | B2 |
| 10080839 | Cole et al. | Sep 2018 | B2 |
| 10086133 | Pananen et al. | Oct 2018 | B2 |
| 10086134 | Pananen et al. | Oct 2018 | B2 |
| 10092701 | Johansen et al. | Oct 2018 | B2 |
| 10105483 | Mernoe | Oct 2018 | B2 |
| 10105497 | Dreier et al. | Oct 2018 | B2 |
| 10130759 | Amirouche et al. | Nov 2018 | B2 |
| 10130763 | Lauchard et al. | Nov 2018 | B2 |
| 10137243 | Wang et al. | Nov 2018 | B2 |
| 10141882 | Favreau | Nov 2018 | B2 |
| 10146911 | Trock | Dec 2018 | B2 |
| 10166327 | Tieck et al. | Jan 2019 | B2 |
| 10172998 | Tieck et al. | Jan 2019 | B2 |
| 10172999 | Tieck et al. | Jan 2019 | B2 |
| 10207047 | Estes | Feb 2019 | B2 |
| 10213549 | Amirouche et al. | Feb 2019 | B2 |
| 10220143 | Moberg et al. | Mar 2019 | B2 |
| 10228663 | Favreau | Mar 2019 | B2 |
| 10232109 | Deak et al. | Mar 2019 | B2 |
| 10238030 | Urbani | Mar 2019 | B2 |
| 10238793 | Deak et al. | Mar 2019 | B2 |
| 10252001 | Geismar et al. | Apr 2019 | B2 |
| 10258736 | Metzmaker et al. | Apr 2019 | B2 |
| 10272196 | Smith et al. | Apr 2019 | B2 |
| 10279110 | Mann et al. | May 2019 | B2 |
| 10300264 | Halili et al. | May 2019 | B2 |
| 10307536 | Causey et al. | Jun 2019 | B2 |
| 10322227 | Piehl et al. | Jun 2019 | B2 |
| 10363365 | Bazargan | Jul 2019 | B2 |
| 10376631 | Tieck et al. | Aug 2019 | B2 |
| 10376632 | Tieck et al. | Aug 2019 | B2 |
| 10384013 | Krusell et al. | Aug 2019 | B2 |
| 10391257 | Piehl et al. | Aug 2019 | B2 |
| 10478554 | Bazargan et al. | Nov 2019 | B2 |
| 10517892 | Chattaraj et al. | Dec 2019 | B2 |
| 10532156 | Istoc | Jan 2020 | B2 |
| 10552580 | Bazargan | Feb 2020 | B2 |
| 10603431 | Mernoe et al. | Mar 2020 | B2 |
| 10772796 | Kavazov | Sep 2020 | B2 |
| 10850032 | Steck et al. | Dec 2020 | B2 |
| 10857287 | Damiano et al. | Dec 2020 | B2 |
| 10861591 | Grosman et al. | Dec 2020 | B2 |
| 10881789 | Damiano et al. | Jan 2021 | B2 |
| 10960136 | Palerm et al. | Mar 2021 | B2 |
| 11278661 | Damiano et al. | Mar 2022 | B2 |
| 20020038392 | De La Huerga | Mar 2002 | A1 |
| 20020055711 | Lavi et al. | May 2002 | A1 |
| 20020065484 | Douglas et al. | May 2002 | A1 |
| 20020161332 | Ramey | Oct 2002 | A1 |
| 20030009133 | Ramey | Jan 2003 | A1 |
| 20050015056 | Duchon et al. | Jan 2005 | A1 |
| 20050020980 | Inoue | Jan 2005 | A1 |
| 20050038387 | Kriesel | Feb 2005 | A1 |
| 20050051580 | Ramey | Mar 2005 | A1 |
| 20050154434 | Simon et al. | Jul 2005 | A1 |
| 20050256461 | DiFiore | Nov 2005 | A1 |
| 20060264908 | Ishii et al. | Nov 2006 | A1 |
| 20070088271 | Richards | Apr 2007 | A1 |
| 20070142786 | Lampropoulos | Jun 2007 | A1 |
| 20070161955 | Bynum et al. | Jul 2007 | A1 |
| 20070273671 | Zadesky et al. | Nov 2007 | A1 |
| 20070282294 | Sidler | Dec 2007 | A1 |
| 20080051719 | Moberg | Feb 2008 | A1 |
| 20080188813 | Miller et al. | Aug 2008 | A1 |
| 20080243085 | DeStefano | Oct 2008 | A1 |
| 20080262425 | Mogensen | Oct 2008 | A1 |
| 20080319383 | Byland | Dec 2008 | A1 |
| 20090062767 | Van Antwerp et al. | Mar 2009 | A1 |
| 20090326506 | Hasegawa et al. | Dec 2009 | A1 |
| 20100049144 | McConnell et al. | Feb 2010 | A1 |
| 20100145303 | Yodfat | Jun 2010 | A1 |
| 20100191165 | Appling | Jul 2010 | A1 |
| 20100217241 | Mann et al. | Aug 2010 | A1 |
| 20100241103 | Kraft et al. | Sep 2010 | A1 |
| 20110021905 | Patrick et al. | Jan 2011 | A1 |
| 20110118659 | Maaskamp | May 2011 | A1 |
| 20110160697 | Yodfat et al. | Jun 2011 | A1 |
| 20110230838 | Adams et al. | Sep 2011 | A1 |
| 20110288494 | Mendels | Nov 2011 | A1 |
| 20120078185 | Smith | Mar 2012 | A1 |
| 20120078197 | O'Connor et al. | May 2012 | A1 |
| 20120211946 | Halili et al. | Aug 2012 | A1 |
| 20120211947 | Halili et al. | Aug 2012 | A1 |
| 20120215177 | Halili et al. | Aug 2012 | A1 |
| 20120215178 | Halili et al. | Aug 2012 | A1 |
| 20120215179 | Halili et al. | Aug 2012 | A1 |
| 20120215180 | Halili et al. | Aug 2012 | A1 |
| 20120215183 | Halili et al. | Aug 2012 | A1 |
| 20120226234 | Bazargan et al. | Sep 2012 | A1 |
| 20130046253 | Yavorsky et al. | Feb 2013 | A1 |
| 20130085470 | O'Connor et al. | Apr 2013 | A1 |
| 20130245604 | Kouyoumjlan et al. | Sep 2013 | A1 |
| 20130345641 | German | Dec 2013 | A1 |
| 20150057615 | Mernoe et al. | Feb 2015 | A1 |
| 20150073384 | Limaye | Mar 2015 | A1 |
| 20150105720 | Montalvo et al. | Apr 2015 | A1 |
| 20150202375 | Schabbach et al. | Jul 2015 | A1 |
| 20150265826 | Dudley | Sep 2015 | A1 |
| 20150314063 | Nagar et al. | Nov 2015 | A1 |
| 20150357683 | Lohr | Dec 2015 | A1 |
| 20160015885 | Pananen et al. | Jan 2016 | A1 |
| 20160015886 | Pananen et al. | Jan 2016 | A1 |
| 20160015887 | Pananen et al. | Jan 2016 | A1 |
| 20160015911 | Bazargan et al. | Jan 2016 | A1 |
| 20160051760 | Krusell et al. | Feb 2016 | A1 |
| 20160058668 | Metzmaker et al. | Mar 2016 | A1 |
| 20160074587 | Searle et al. | Mar 2016 | A1 |
| 20160082182 | Gregory et al. | Mar 2016 | A1 |
| 20160089493 | Crouther et al. | Mar 2016 | A1 |
| 20160106919 | Hayter et al. | Apr 2016 | A1 |
| 20160184519 | Blundred et al. | Jun 2016 | A1 |
| 20160220754 | Shaanan et al. | Aug 2016 | A1 |
| 20160263324 | Shaanan et al. | Sep 2016 | A1 |
| 20160271322 | Ramey et al. | Sep 2016 | A1 |
| 20160361494 | Jurg et al. | Dec 2016 | A1 |
| 20170056590 | DiPerna | Mar 2017 | A1 |
| 20170065768 | Moore | Mar 2017 | A1 |
| 20170182307 | Halili et al. | Jun 2017 | A1 |
| 20170189666 | Sealfon et al. | Jul 2017 | A1 |
| 20170192506 | Andersen et al. | Jul 2017 | A1 |
| 20170216523 | Neftel et al. | Aug 2017 | A1 |
| 20170235920 | Bauss et al. | Aug 2017 | A1 |
| 20170239422 | Kodgule et al. | Aug 2017 | A1 |
| 20170286638 | Searle et al. | Oct 2017 | A1 |
| 20170312454 | Chattaraj et al. | Nov 2017 | A1 |
| 20180036475 | Lin | Feb 2018 | A1 |
| 20180043104 | Mueller-Pathle | Feb 2018 | A1 |
| 20180043105 | Nazzaro et al. | Feb 2018 | A1 |
| 20180103897 | Amirouche | Apr 2018 | A1 |
| 20180104417 | Nessel et al. | Apr 2018 | A1 |
| 20180117248 | Cabiri et al. | Jun 2018 | A1 |
| 20180117296 | Damiano et al. | Jun 2018 | A1 |
| 20180207366 | Marcoz et al. | Jul 2018 | A1 |
| 20180228979 | Schildt et al. | Aug 2018 | A1 |
| 20180280624 | Bitton et al. | Oct 2018 | A1 |
| 20180311435 | Galasso | Nov 2018 | A1 |
| 20180318498 | Grant et al. | Nov 2018 | A1 |
| 20180318506 | Oakes et al. | Nov 2018 | A1 |
| 20180326164 | Bauss et al. | Dec 2018 | A1 |
| 20180353699 | Helmer et al. | Dec 2018 | A1 |
| 20190001060 | Gylleby et al. | Jan 2019 | A1 |
| 20190009032 | Hautaviita et al. | Jan 2019 | A1 |
| 20190015582 | Naftalovitz et al. | Jan 2019 | A1 |
| 20190030247 | Edwards et al. | Jan 2019 | A1 |
| 20190054251 | Pieronek et al. | Feb 2019 | A1 |
| 20190091460 | Yavorsky et al. | Mar 2019 | A1 |
| 20190134305 | Srinivasan et al. | May 2019 | A1 |
| 20190151559 | Byerly et al. | May 2019 | A1 |
| 20190167900 | Friedli et al. | Jun 2019 | A1 |
| 20190192762 | Metzmaker et al. | Jun 2019 | A1 |
| 20190209775 | Merchant | Jul 2019 | A1 |
| 20190217007 | Sasaki | Jul 2019 | A1 |
| 20200330719 | Segal | Oct 2020 | A1 |
| 20210030949 | Damiano et al. | Feb 2021 | A1 |
| 20210030957 | Damiano et al. | Feb 2021 | A1 |
| 20210093777 | Damiano et al. | Apr 2021 | A1 |
| 20210093849 | Stumpe et al. | Apr 2021 | A1 |
| 20210106750 | Damiano et al. | Apr 2021 | A1 |
| Number | Date | Country |
|---|---|---|
| 3 150 241 | Jun 2018 | EP |
| 3 378 516 | Sep 2018 | EP |
| 57-124151 | Aug 1982 | JP |
| 59-30241 | Feb 1984 | JP |
| 2012-200381 | Oct 2012 | JP |
| 3194787 | Dec 2014 | JP |
| 2549310 | Apr 2015 | RU |
| WO 9964103 | Dec 1999 | WO |
| WO 02094352 | Nov 2002 | WO |
| WO 03017915 | Mar 2003 | WO |
| WO 04045704 | Jun 2004 | WO |
| WO 05000378 | Jan 2005 | WO |
| WO 05004973 | Jan 2005 | WO |
| WO 06054367 | May 2006 | WO |
| WO 07075677 | Jul 2007 | WO |
| WO 09069511 | Apr 2009 | WO |
| WO 07086186 | May 2009 | WO |
| WO 09060741 | May 2009 | WO |
| WO 11079225 | Jun 2011 | WO |
| WO 11131775 | Oct 2011 | WO |
| WO 11131778 | Oct 2011 | WO |
| WO 12008285 | Jan 2012 | WO |
| WO 12072555 | Jun 2012 | WO |
| WO 12110474 | Aug 2012 | WO |
| WO 12115911 | Aug 2012 | WO |
| WO 12146670 | Nov 2012 | WO |
| WO 12160104 | Nov 2012 | WO |
| WO 13093059 | Jun 2013 | WO |
| WO 13161979 | Oct 2013 | WO |
| WO 14104027 | Mar 2014 | WO |
| WO 14159213 | Oct 2014 | WO |
| WO 15027174 | Feb 2015 | WO |
| WO 15061690 | Apr 2015 | WO |
| WO 15061691 | Apr 2015 | WO |
| WO 15061693 | Apr 2015 | WO |
| WO 15155229 | Oct 2015 | WO |
| WO 15166993 | Nov 2015 | WO |
| WO 17007968 | Jan 2017 | WO |
| WO 17199012 | Nov 2017 | WO |
| WO 17217105 | Dec 2017 | WO |
| WO 18129354 | Jul 2018 | WO |
| WO 19021985 | Jan 2019 | WO |
| WO 19046593 | Mar 2019 | WO |
| Entry |
|---|
| Boston University, Jan. 2014, Bionic Pancreas: Introducing the ILet 1294 1000, http://sites.bu.edu/bionicpacreas/introducing-the-ilet-1294-1000/, 3 pp. |
| Brown et al., Apr. 1, 2016, Introducing Beta Bionics: bringing the iLet bionic pancreas to market, https://diatribe.org/introducing-beta-bionics-bringing-ilet-bionic-pancreas-marekt, 3 pp. |
| Hoskins, Oct. 2, 2018, iLet “Bionic Pancreas” making progress with gen 4 device, Healthline, https″//www.healthline.com/diabetesmine/beta-bionics-ilet-update#1, 15 pp. |
| Idlebrook, Jul. 30, 2019, Beta Bionics secures funding for pivotal iLet bionic pancreas trials, https://t1dexchange.org/welcome-glu-users/articles/beta-bionics-secures-funding-for-pivotal-ilet-bionic-pancreas-trials, 4 pp. |
| Kolind et al., “Preservative-free drug for insulin pumps,” Novo Nordisk Pharmaceutical company, Pump partner meeting ATTD 2020, WOP Technology Presentation, 26 pages. |
| Krugman, Aug. 25, 2018, iLet Bionic Pancreas Interface, sarakrugman.com/ilet-interface, 3 pp. |
| Ping One Touch Owner's Booklet, Dated Oct. 2014, (360 pages). |
| Renesas Synergy™ Platform, “Capacitive Touch Hardware Design and Layout Guidelines for Synergy, RX200, and RX100.” R01AN3825EU0101 Rev.1.01, Jun. 14, 2017, pp. 1-18. |
| Sifferlin, Apr. 1, 2016, The bionic pancreas is getting closer to reality, time.com, https://time.com/4278068/bionic-pancreas-company, 5 pp. |
| Number | Date | Country | |
|---|---|---|---|
| 20220257853 A1 | Aug 2022 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 16814925 | Mar 2020 | US |
| Child | 17655532 | US |
