Injection pump apparatus, method and system

Abstract

Providing injection pump devices, methods, and systems. [Solution] The system is disclosed. The system includes a filling adapter device (700) which includes a heat exchanger including a heating element (706) and a fluid path (712), the fluid path being fluidically connected to a filling needle input (714), the fluid entering the heat exchanger through the filling needle input, flowing through the fluid path, and being heated by the heating element. The system also includes a reservoir (704) which includes a plunger (708) and a plunger rod, and a filling needle (710) configured to be detachably attached to the reservoir, the filling adapter being configured to be attached to a fluid vial (702), the fluid from the vial flowing through the fluid path, being heated, and being loaded into the reservoir through the filling needle.

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application is a non - provisional patent application claiming priority to U.S. Provisional Patent Application No. 61 / 301,957, entitled "Infusion Pump Apparatus, Method and System", filed on February 5, 2010, Attorney Docket No. H91, which is incorporated herein by reference in its entirety.

[0002] (Field of the Invention) The present disclosure relates to medical devices, and more particularly, to infusion pump apparatuses, methods, and systems.

Background Art

[0003] Many potentially valuable drugs or compounds, including biological agents, are not orally effective due to poor absorption rates, hepatic metabolism, or other pharmacokinetic factors. Further, some therapeutic compounds can be absorbed orally but may need to be administered frequently, and it is difficult for patients to maintain a desired schedule. In these cases, parenteral delivery is often employed or is possible.

[0004] Effective parenteral routes for drug delivery and other fluids and compounds, such as subcutaneous injection, intramuscular injection, and intravenous (IV) administration, involve piercing the skin with a needle or stylet. Insulin is an example of a therapeutic fluid that is self - injected by millions of diabetics. Users of drugs delivered parenterally can benefit from wearable devices that automatically deliver the required drug / compound over a period of time.

[0005] To achieve this objective, efforts have been made to design portable and wearable devices for the controlled release of therapeutic drugs. Such devices are known to have reservoirs such as cartridges, syringes, or bags and to be electronically controlled. These devices have several drawbacks, including failure rates. Reducing the size, weight, and cost of these devices is also an ongoing challenge. Furthermore, these devices are often applied to the skin, which presents the challenge of frequent repositioning for application. [Overview of the project] [Means for solving the problem]

[0006] According to one aspect of the present invention, a system is disclosed. The system includes a filling adapter device including a heat exchanger including a heating element and a fluid path, the fluid path being fluidically connected to a filling needle input, the fluid entering the heat exchanger through the filling needle input, flowing through the fluid path, and the fluid being heated by the heating element. The system also includes a reservoir including a plunger and a plunger rod, and a filling needle configured to be detachably attached to the reservoir, the filling adapter configured to be attached to a vial of fluid, the fluid from the vial flowing through the fluid path, being heated, and being loaded into the reservoir through the filling needle.

[0007] Some embodiments of this aspect of the present invention may include one or more of the following: The system further includes a pump for delivering fluid into a fluid path at a predetermined rate. The system further includes a check valve for measuring the fluid into the fluid path, thereby controlling the flow rate of fluid through the heat exchanger. The system further includes a processor for controlling the heating of the fluid according to one or more pre-programmed profiles. The system further includes a filling needle input being a partition. The system further includes an air trap, which allows air to flow out of the heat exchanger. The system further includes an air trap equipped with a hydrophobic filter.

[0008] According to one aspect of the present invention, a filling adapter device is disclosed. The filling adapter device includes a heat exchanger including a heating element and a fluid path, the fluid path being fluidly connected to the filling needle input and the vial, the fluid from the vial entering the heat exchanger and flowing through the fluid path, and the fluid being heated by the heating element.

[0009] Some embodiments of this aspect of the present invention may include one or more of the following: The device further includes a pump for delivering fluid into a fluid path at a predetermined rate. The device further includes a check valve for measuring the fluid into the fluid path, thereby controlling the flow rate of fluid through the heat exchanger. The device further includes a processor for controlling the heating of the fluid according to one or more pre-programmed profiles. The device further includes a filling adapter configured to be attached to a fluid vial. The device further includes a filling needle input being a partition. The device further includes an air trap, which allows air to flow out of the heat exchanger. The device further includes an air trap comprising a hydrophobic filter.

[0010] According to one aspect of the present invention, a method for reducing atmospheric pressure inside an injection pump is disclosed. The method includes a pressure sensor that transmits data to a pump processor at predetermined intervals; a step of determining whether the data exceeds a warning threshold; if the data exceeds a predetermined warning threshold, a step of the processor instructing the user to disconnect from the cannula; a step of determining whether the data meets a predetermined safety threshold; and a step of instructing the user to reconnect to the cannula.

[0011] According to one aspect of the present invention, an injection pump system is disclosed. The system includes a reservoir, an active check valve located downstream of the reservoir and upstream of the cannula, a passive check valve located downstream of the reservoir and having a cracking pressure, and a pump processor, wherein the active check valve is opened by the pump processor for scheduled pump delivery, and when the fluid pressure overcomes the cracking pressure, the passive check valve opens and the fluid flows from the reservoir through the passive check valve.

[0012] According to one aspect of the present invention, an injection pump system is disclosed. The system includes a reservoir and at least one valve located downstream of the reservoir, the at least one valve being a pressure-compensating valve having a cracking pressure, and a pressure difference related to a change in the altitude of the injection pump causes the at least one valve to open.

[0013] According to one aspect of the present invention, a method for reducing atmospheric pressure in an injection pump is disclosed. The method includes the steps of: receiving information relating to scheduled departure and scheduled landing times; modifying the frequency of processing altitude-related data based on the information; determining whether a schedule change has occurred by comparing the information with an altimeter; alerting the user to the schedule change; requesting updated schedule information; and modifying the scheduled delivery of the fluid based on the input schedule and altimeter data.

[0014] According to one aspect of the present invention, an injection pump system is disclosed. The system includes a reservoir having a plunger, at least one sensor for determining the location of the plunger, and a processor configured to receive information from at least one sensor. The processor is configured to modify the frequency of determining the location of the plunger, and the processor is configured to determine the volume of fluid to be drawn into or delivered out of the reservoir, and to modify the scheduled pump delivery for a given amount over a given time.

[0015] According to one aspect of the present invention, a system for temperature compensation of an injection pump is disclosed. The system comprises at least one temperature sensor and at least one processor, the processor in communication with the temperature sensor, the processor determining a target plunger position based at least on communication from the temperature sensor, and correcting the target plunger position based on the sensed temperature.

[0016] According to one aspect of the present invention, a system for reducing pressure in an injection pump is disclosed. The system includes at least one pressure sensor and a processor, the pressure sensor transmits data to the processor, and the processor reduces the pressure change when the pressure change meets a pre-programmed threshold.

[0017] These aspects of the present invention are not intended to be exclusive, and other features, aspects, and advantages of the present invention will be readily apparent to those skilled in the art when read in conjunction with the appended claims and drawings. For example, the present invention provides the following items. (Item 1) A system, said system A filling adapter device, wherein the filling adapter device is Heat exchanger including heating element and fluid path A filling adapter device comprising a fluid path which is fluidically connected to a filling needle input, thereby allowing fluid to enter the heat exchanger through the filling needle input and flow through the fluid path, thereby heating the fluid by the heating element, A reservoir including a plunger and plunger rod, A filling needle configured to be removably attached to the reservoir and Includes, The filling adapter is configured to be attached to a fluid vial, and the fluid from the vial flows through the fluid path, is heated, and is loaded into the reservoir through the filling needle, in a system. (Item 2) The filling adapter according to item 1, further comprising a pump for delivering fluid into the fluid path at a predetermined rate. (Item 3) The filling adapter according to item 1, further comprising a check valve for measuring the fluid into the fluid path, whereby the flow rate of the fluid passing through the heat exchanger is controlled. (Item 4) The filling adapter according to item 1, further comprising a processor for controlling the heating of the fluid according to one or more pre-programmed profiles. (Item 5) The filling needle input is a partition wall, the filling adapter according to item 1. (Item 6) The filling adapter according to item 1, further comprising an air trap, whereby the air trap allows air to flow out of the heat exchanger. (Item 7) The air trap of the filling adapter according to item 6 comprises a hydrophobic filter. (Item 8) A filling adapter device, the device comprising A heat exchanger including a heating element and a fluid path, The fluid path is fluidly connected to a filling needle input and a vial, whereby fluid from the vial enters the heat exchanger, flows through the fluid path, and whereby the fluid is heated by the heating element. (Item 9) The filling adapter according to item 8, further comprising a pump for delivering fluid into the fluid path at a predetermined rate. (Item 10) The filling adapter according to item 8, further comprising a check valve for measuring the fluid into the fluid path, whereby the flow rate of the fluid passing through the heat exchanger is controlled. (Item 11) The filling adapter according to item 8, further comprising a processor for controlling the heating of the fluid according to one or more pre-programmed profiles. (Item 十二) The filling adapter according to item 8, configured to be attached to a fluid vial. (Item 13) The filling needle input according to item 8, which is a partition wall. (Item 14) The filling adapter according to item 8, further comprising an air trap, whereby the air trap enables air to flow out of the heat exchanger. (Item 15) The filling adapter according to item 14, wherein the air trap comprises a hydrophobic filter. (Item 16) A method for atmospheric relief in an injection pump, the method comprising: A pressure sensor that transmits data to a pump processor at predetermined intervals; Determining whether the data exceeds a warning threshold; If the data exceeds a predetermined warning threshold, the processor indicates to the user to disconnect from the cannula; Determining whether the data meets a predetermined safety threshold; Indicating to the user to reconnect to the cannula and including. (Item 17) An injection pump system, the system comprising: A reservoir; An active check valve located downstream from the reservoir and upstream from the cannula; A passive check valve located downstream from the reservoir and having a cracking pressure; A pump processor, wherein the active check valve is opened by the pump processor for a predetermined pump delivery; and including, A system in which when the fluid pressure overcomes the cracking pressure, the passive check valve opens and fluid flows from the reservoir through the passive check valve. (Item 18) An injection pump system, the system comprising: A reservoir; At least one valve downstream of the reservoir, the at least one valve is a pressure compensating valve having a cracking pressure, and a pressure difference related to a change in the altitude of the injection pump causes the at least one valve to open. A system that includes this. (Item 19) A method for reducing the amount of air inside an injection pump, the method is To receive information related to scheduled departure and landing times, Based on this information, adjust the frequency with which highly relevant data is processed, By comparing this information with the altimeter, it is possible to determine whether or not a schedule change has occurred. To warn users about schedule changes, Requesting updated schedule information, Based on the entered schedule and altimeter data, the scheduled delivery of the fluid will be modified. Methods that include... (Item 20) An injection pump system, wherein the system is A reservoir equipped with a plunger, At least one sensor for determining the location of the plunger, A processor that receives information from at least one sensor, modifies the frequency of determining the location of the plunger, determines the volume of fluid to be drawn into or delivered out of the reservoir, and modifies the scheduled pump delivery for a given amount of time. A processor and A system that includes this. (Item 21) A system for temperature compensation of an injection pump, the system is At least one temperature sensor, At least one processor, which is in contact with the temperature sensor and Includes, A system comprising a processor that determines the target plunger position based at least on communication from the temperature sensor and corrects the target plunger position based on the sensed temperature. (Item 22) A system for reducing the pressure of an injection pump, the system is At least one pressure sensor, Processor and A system comprising a pressure sensor that transmits data to a processor, and the processor mitigates the pressure change when the pressure change meets a pre-programmed threshold.

[0018] These and other features and advantages of the present invention will be better understood by reading the following detailed description, which will be interpreted in conjunction with the following drawings. [Brief explanation of the drawing]

[0019] [Figure 1-1] Figures 1A and 1B are isometric views of the front and rear of an embodiment of the injection pump. [Figure 1-2] Figures 1C to 1E are side and front views of the injection pump assembly shown in Figure 1. Figure 1F is a front isometric view of the injection pump assembly shown in Figure 1. [Figure 3] Figure 3 is an illustrative diagram of one embodiment of a remote control assembly. [Figure 4] Figure 4 is a diagram of the injection pump assembly shown in Figure 1. [Figure 10] Figures 10A to 10E illustrate multiple Velcro® configurations according to several embodiments. [Figure 11] Figure 11 is an explanatory diagram of one embodiment of the holder. [Figure 12] Figure 12 is an explanatory diagram of one embodiment of a user attaching the holder. [Figure 13] Figure 13 is an explanatory diagram of one embodiment of the back of the holder. [Figure 14] Figure 14 is an explanatory diagram of one embodiment of a vial with a thermometer / label. [Figure 15] Figure 15 is a flowchart of one embodiment of a method for determining and reducing atmospheric pressure. [Figure 16] Figure 16 is an explanatory diagram of one embodiment of a passive and active check valve. [Figure 17] Figure 17 is an explanatory diagram of a cross-sectional view of one embodiment of a filling adapter. [Figure 18] Figure 18 is an explanatory diagram of a vial system for maintaining a vacuum inside a vial, according to one embodiment. [Figure 19] Figure 19 is an explanatory diagram of a vial device according to one embodiment, and Appendix A is an embodiment of a micro check valve used in several embodiments. [Modes for carrying out the invention]

[0020] (definition) As used in this description and the attached claims, the following terms shall have the meanings shown unless the context requires otherwise.

[0021] "Device" means a medical device including, but not limited to, an infusion pump and / or controller, i.e., a device for wireless control of another medical device. In some embodiments, the term "device" is used interchangeably with "pump," "infusion pump," and / or "controller," and / or "companion," and / or "remote controller device," and / or "remote controller assembly."

[0022] "Companion" means a device for wireless control of another medical device. In exemplary embodiments, the companion may also include a glucose meter / piece reader.

[0023] The "inputs" of a device include any mechanisms by which the device user or other operator / caregiver can control the device's functions. User inputs may include mechanical arrangements (e.g., switches, push buttons, (multiple) jog wheels), electrical arrangements (e.g., sliders, touch screens), wireless interfaces for communication with remote controllers (e.g., RF, infrared), acoustic interfaces (e.g., with voice recognition), computer network interfaces (e.g., USB ports), and other types of interfaces.

[0024] In the context of inputs such as the so-called "bolus button" discussed below, "button" may refer to any type of user input capable of performing a desired function, and is not limited to push buttons, sliders, switches, touch screens, or jog wheels.

[0025] "Alarm" includes any mechanism by which a warning may be generated to the user or a third party. An alarm may include an audible alarm (e.g., speaker, buzzer, voice generator), a visual alarm (e.g., LED, LCD screen), a tactile alarm (e.g., vibration element), a wireless signal (e.g., wireless transmission to a remote controller or caregiver), or other mechanisms. An alarm may be generated by using multiple mechanisms simultaneously, in parallel, or sequentially, including redundant mechanisms (e.g., two different acoustic alarms) or complementary mechanisms (e.g., an acoustic alarm, a tactile alarm, and a wireless alarm).

[0026] "Fluid" refers to a substance that can flow through streamlines, such as a liquid.

[0027] "User" includes any individual or animal that receives fluid from a fluid delivery device, whether as part of drug therapy or another method, or any caregiver or third party involved in programming the device to inject fluid into something else, or otherwise interacting with the device.

[0028] "Cannula" means a disposable device capable of injecting fluid into a user. As used herein, a cannula may refer to a conventional cannula or needle.

[0029] "Disposable" refers to parts, devices, components, or other items that are intended to be used for a fixed period of time and then discarded or replaced.

[0030] "Reusable" refers to a part intended to have an unlimited usage period.

[0031] "Acoustic capacitance measurement" means the quantitative measurement of relevant capacitance using acoustic techniques, such as those described in U.S. Patents No. 5,349,852 and No. 5,641,892, which are incorporated herein by reference in their entirety, as well as other techniques.

[0032] A “temperature sensor” includes any temperature determination device / mechanism for measuring temperature and communicating temperature information to a controller and / or pump processor. The devices described herein may include one or more temperature sensors for measuring one or more of the following: user skin temperature, AVS temperature, ambient temperature, internal pump temperature, plunger temperature, drive system temperature, and fluid temperature.

[0033] Illustrative uses of embodiments of the devices, methods, and systems described herein are for the delivery of insulin to people living with diabetes, but other uses include the delivery of any fluid as described above. Fluids include analgesics for people in pain, chemotherapy for cancer patients, and enzymes for patients with metabolic diseases. Various therapeutic fluids may include small molecules, natural products, peptides, proteins, nucleic acids, carbohydrates, nanoparticle suspensions, and associated pharmaceutically acceptable carrier molecules. Therapeutically active molecules may be modified to improve their stability within the device (e.g., by pegylation of peptides or proteins). While the exemplary embodiments herein describe drug delivery applications, embodiments may be used for other applications including lab-on-a-chip applications and liquid dispensing of reagents for high-throughput analytical measurements such as capillary chromatography. For the purposes of the following description, the terms “therapeutic,” “insulin,” and “fluid” are used interchangeably, but in other embodiments, any fluid may be used as described above. Thus, the devices and descriptions contained herein are not limited to therapeutic use.

[0034] Several embodiments of fluid delivery devices are adapted for use by people living with diabetes and / or their caregivers. Thus, in these embodiments, the devices, methods, and systems work to deliver insulin that assists or replaces the action of pancreatic islet beta cells in an individual living with diabetes (referred to as the user). Embodiments adapted for insulin delivery attempt to mimic the action of the pancreas by providing both basal-level fluid delivery and bolus-level delivery. Basal levels, bolus levels, and timing may be set by the user or caregiver using a wireless handheld user interface, or directly by using a pump. In addition, basal and / or bolus levels may be induced or adjusted in response to the output of a glucose meter integrated with a controller, in exemplary embodiments. In other embodiments, the controller also includes a glucose monitoring device that receives data from a blood glucose sensor. In some embodiments, boluses may be induced by the user using designated buttons or other input means located on the device, i.e., on the controller and / or the infusion pump. In other embodiments, the bolus or base may be programmed or administered via a user interface located on either the fluid delivery device injection pump or / or the controller.

[0035] With regard to the names and types of screens given to them, as well as the appropriate names given to various features, these terms may vary throughout the various embodiments.

[0036] The systems and methods described herein may be used to control an infusion pump. For the purposes of this description, various embodiments of the user interface and infusion pump may be described with reference to an insulin pump, or a pump that infuses insulin. However, it should be understood that the user interface may be on the infusion pump and / or on the controller. In addition, where the description relates to an infusion pump “screen”, this “screen” may also appear on the controller, or may appear on the controller instead of the pump.

[0037] The infusion pumps discussed herein include pumps capable of delivering any fluid, including but not limited to therapeutic fluids, including but not limited to insulin. Therefore, when this description describes exemplary embodiments in relation to insulin, this is for illustrative purposes only, as the device is not intended to be limited to insulin. Other fluids may also be considered. In some embodiments, the methods, systems, and devices described herein may be used in conjunction with insulin “pens” and / or fluid delivery “pens” known in the art.

[0038] The infusion pump may be any infusion pump, for example, but may include, but is not limited to, the pump devices shown and described with respect to Figures 1A-1F and incorporated herein by reference. In various exemplary embodiments, the infusion pump is a syringe pump, i.e., a plunger advances through the syringe, pushing the fluid inside the syringe into a cannula, which then delivers or provides the fluid to the user. If the cannula is connected to the user (i.e., the cannula is in the user's subcutaneous region), the fluid is delivered subcutaneously to the user.

[0039] In exemplary embodiments, the injection pump includes hardware for wireless RF communication with the controller. However, in various embodiments, the injection pump may be any injection pump. Referring to Figures 1A-1F and 2A-2D, in some exemplary embodiments, the injection pump may include a display assembly 104, but in other exemplary embodiments, such as those shown in Figures 2A-2D, the injection pump may not include a display assembly. In these embodiments, a display assembly similar to, or larger than, or smaller than, the one shown in Figures 1A, 1D, and 1F is included on the controller or companion device. Embodiments of the controller or companion device are shown in Figure 3.

[0040] Referring to Figures 1A–1F, embodiments of an injection pump assembly 100 that may be housed within an encasing assembly 102 are shown. The injection pump assembly 100 may include a display system 104 that may be visible through the encasing assembly 102. One or more switch assemblies / input devices 106, 108, 110 may be positioned around various parts of the encasing assembly 102. The encasing assembly 102 may include an injection port assembly 112 to which a cannula assembly 114 may be releasably connected. A removable cover assembly 116 may allow access to a power cavity 118 (shown as a phantom in Figure 1D).

[0041] Referring to the injection pump assembly shown in Figures 1A to 1F, the injection pump assembly 100 may include processing logic (not shown), which may be called a pump processor, that performs one or more processes that may be required for the injection pump assembly 100 to operate properly. The processing logic may include one or more microprocessors (not shown), one or more input / output controllers (not shown), and a cache memory device (not shown). One or more data buses and / or memory buses may be used to interconnect the processing logic with one or more subsystems. In some embodiments, at least one of the subsystems shown in Figure 4 is also included in the embodiment of the injection pump assembly 200 shown in Figures 2A to 2D.

[0042] Referring here to Figures 1A to 1F and Figure 4, embodiments of subsystems interconnected with the processing logic 400 may include, but are not limited to, a memory system 402, an input system 404, a display system 406, a vibration system 408, an acoustic system 410, a motor assembly 416, a force sensor 412, a temperature sensor (not shown), and a displacement detection device 418 (which may be called a device that determines and / or detects the distance the plunger has moved relative to the syringe barrel / syringe). The injection pump assembly 100 may include a mains power supply 420 (e.g., a battery) configured to be removable and installable from a power cavity 118 and to provide power to at least a portion of the processing logic 400 and one or more of the subsystems (e.g., the memory system 402, the input system 404, the display system 406, the vibration system 408, the acoustic system 410, the motor assembly 416, the force sensor 412, and the displacement detection device 418).

[0043] The injection pump assembly 100 may include a reservoir assembly 430 configured to contain an injectable fluid 422. In some embodiments, the reservoir assembly 430 is similar to a reservoir assembly described in U.S. Patent No. 7,498,563, issued March 3, 2009, titled Optical Displacement Sensor for Infusion Devices, and / or U.S. Patent No. 7,306,578, issued December 11, 2007, titled Loading Mechanism for Infusion Pump, International Application PCT / US2009 / 060158, filed October 9, 2009, titled Infusion Pump Assembly, International Publication WO2010 / 042814 (Agent Reference Number F51WO), published April 15, 2010, and Infusion Pump, filed October 10, 2008. The reservoir assemblies may be as described in U.S. Patent Application No. 12 / 249,882, titled "Assembly," now published U.S. Patent Application No. US-2010-0094222 (Agent Reference Number F51) on April 15, 2010, all of which are incorporated herein by reference in their entirety. In other embodiments, the reservoir assembly may be any assembly that can be acted upon so that a fluid may flow out of the reservoir assembly in any way that at least a portion of the fluid may flow out of the reservoir assembly, for example, the reservoir assembly may include, but is not limited to, a barrel having a plunger, a cassette, and / or a container constructed of at least partially flexible membrane.

[0044] The plunger assembly 424 may be configured to displace the injectable fluid 422 from the reservoir assembly 430 through the cannula assembly 450 (which may be connected to the injection pump assembly 100 via the injection port assembly 424) so ​​that the injectable fluid 422 can be delivered to the user 454. In this particular embodiment, the plunger assembly 424 is shown to be displaceable by a partial nut assembly 426 which may engage with a feed screw assembly 428 which may be rotatable by a motor assembly 416 in response to a signal received from the processing logic 400. In this particular embodiment, the combination of the motor assembly 416, the plunger assembly 424, the partial nut assembly 426, and the feed screw assembly 428 may form a pump assembly that achieves the dispensing of the injectable fluid 422 contained in the reservoir assembly 430. Embodiments of the partial nut assembly 426 include, but are not limited to, a nut assembly configured to wrap around the feed screw assembly 426 by only 30 degrees. In some embodiments, the pump assembly may be similar to those described in U.S. Patent Application No. 7,306,578, issued on December 11, 2007, entitled Loading Mechanism for Infusion Pump (Agent Reference No. C54), U.S. Patent Application No. 12 / 249,882, filed on October 10, 2008, entitled Infusion Pump Assembly, U.S. Patent Application Publication No. US-2010-0094222, published on April 15, 2010 (Agent Reference No. F51), and U.S. Patent Application No. 12 / 249,891, filed on October 10, 2008, entitled Infusion Pump Assembly, U.S. Patent Application Publication No. US-2009-0099523, published on April 16, 2009 (Agent Reference No. G46), all of which are incorporated herein by reference in their entirety.

[0045] (User interface) Throughout this description, the term "screen" may refer to the "pump," "companion," or "controller." However, in various embodiments, similar screens or methods may be achieved on different devices. For example, where a screen or method is referred to in relation to the "pump," a similarly functional screen or method may be used on the "companion" or "controller" in other embodiments. Since this description includes embodiments relating to both pumps with and without displays, it should be clear that if an embodiment includes an injection pump without a display, any screen may be visible on the companion or controller. Similarly, where a method requires interaction between a user and a pump, when the pump is an injection pump without a display, the interaction may be achieved via a switch assembly on the pump.

[0046] In some embodiments, processing logic including at least one element, such as that shown and described with respect to Figure 4, is used to receive input from a user or caregiver. The user or caregiver uses one or more input devices or assemblies, including but not limited to button / switch assemblies, slider assemblies (for example, any slider described in U.S. Patent Application No. 11 / 999,268, filed December 4, 2007, titled Medical Device Including a Slider Assembly, now published July 24, 2008, U.S. Patent Application Publication No. US-2008-0177900 (Agent Reference Number F14), which is incorporated herein by reference in its entirety), jog wheels, and / or touch screens. The infusion device also receives input from an internal system, including but not limited to an occlusion detection process 438, a confirmation process 440, and a volume measurement technique (e.g., acoustic volume sensing). Using these inputs, the infusion device produces outputs, including, but not limited to, delivery of infusion fluid to the user, or comments, alarms, or warnings to the user. Thus, the inputs are either directly from the user to the pump, directly from the pump system to the processing logic, or from another device, such as a remote controller device (described in more detail below), to the pump. Accordingly, the user or caregiver's interaction experience includes, but is not limited to, reading / viewing text and / or graphics on the display, interaction with a display (located on either the infusion pump device itself or the remote controller device, or both), direct interaction with the display via a touchscreen, interaction with one or more buttons, sliders, jog wheels, one or more glucose flake readers, and one or more sensing via either tactile or acoustic, one or more vibration motors, and / or acoustic systems.Therefore, the term "user interface" is used to encompass all systems and methods by which a user or caregiver interacts with an infusion pump to control it.

[0047] Referring here to Figure 3, in some embodiments of the injection pump system, the injection pump may be remotely controlled using a remote controller assembly 300, also called a controller or companion. The remote control assembly 300 may include all or part of the functionality of the injection pump assembly itself, as shown in Figures 1A to 1F. Thus, in some exemplary embodiments of the injection pump assembly described above, the injection pump assembly (not shown, see in particular Figures 1A to 1F, among other figures) may be configured via the remote control assembly 300. In these particular embodiments, the injection pump assembly may include telemetry circuitry (not shown) that enables communication (e.g., wired or wireless) between the injection pump assembly and, for example, the remote control assembly 300, and thus enables the remote control assembly 300 to control the injection pump assembly 100. The remote control assembly 300 (which may also include a telemetry circuit (not shown) and may be capable of communicating with the injection pump assembly) may include a display assembly 302 and an input assembly which may include an input control device (such as a jog wheel 306, a slider assembly 310, or another conventional mode for inputting to the device) and one or more of the switch assemblies 304, 308. The remote control assembly 300 as shown in Figure 3 includes a jog wheel 306 and a slider assembly 310, but some embodiments may include only one of the jog wheel 306 or the slider assembly 310, or another conventional mode for inputting to the device. In embodiments having a jog wheel 306, the jog wheel 306 may include a wheel, ring, knob, or equivalent, which may be coupled to a rotary encoder or other rotary transducer to provide a control signal based at least partially on the movement of the wheel, ring, knob, or equivalent.

[0048] The remote control assembly 300 may include the ability to pre-program base rates, bolus alarms, and delivery limits, and may allow the user to view history and establish user preferences. The remote control assembly 300 may also include a glucose strip reader 312.

[0049] During use, the remote control assembly 300 may provide commands to the injection pump assembly via a wireless communication channel established between the remote control assembly 300 and the injection pump assembly. Therefore, the user may use the remote control assembly 300 to program / configure the injection pump assembly. Some or all of the communication between the remote control assembly 300 and the injection pump assembly may be encrypted to provide an enhanced level of security.

[0050] In exemplary embodiments of the user interface, the user interface may require user confirmation and user input. Exemplary embodiments of the user interface focus on ensuring that the user understands the effects of various interactions with the pump. Throughout this description of the pump, many embodiments are presented that communicate the results of the user's actions to the user. These features ensure that the user understands their actions and therefore provide the user with greater safety. One such embodiment is through the entire exemplary embodiment of the user interface, where the user presses the back button on the screen after a value has been changed, and the user interface displays a change cancellation confirmation screen, as shown in Figure 6. If the user selects "Yes", the user interface discards the pending changes, closes the confirmation screen, and returns to the previous screen (i.e., the screen before the screen where the user pressed the back button). If the action selection on the "Cancel Change?" confirmation screen is "No", the user presses the confirm button or another button, depending on the embodiment, and the user interface closes the confirmation screen and returns to the screen with the pending changes. This feature prevents the user from assuming that a change has been implemented when it hasn't. Therefore, this feature prevents that situation and ensures the user understands that the change has not been implemented.

[0051] (temperature) In various embodiments of the infusion pump, the user may wear the infusion pump so that the device is attached to the body, such as being attached to a belt, to another part or to clothing or garment, or in some embodiments, in a pocket attached to underwear, or in some embodiments, attached to the user's skin. The user generally wears the infusion pump for nearly 24 hours a day whenever possible, and removes the device for short periods, such as during MRI or other treatments that may affect the device, and / or during showers / baths, but not limited to these. Thus, during the normal process of the user wearing the infusion pump, the infusion pump may be exposed to various temperatures, including temperature fluctuations that may include positive and / or negative temperature fluctuations. These temperature fluctuations may result from the user going outdoors, entering a cold room, entering a hot room, and / or being under a blanket or other warming material.

[0052] As discussed above, the fluid contained in the reservoir while inside the pump, which may but is not limited to insulin, has a coefficient of thermal expansion that may be called the general volumetric thermal expansion coefficient. Therefore, the fluid or insulin expands or contracts during temperature fluctuations / changes, whether positive or negative. Various factors, including but not limited to the rate of temperature change, may contribute to the expansion or contraction of the fluid. Therefore, in some embodiments, the amount of expansion or contraction may be a function of temperature.

[0053] In addition, in various embodiments of the device described, the components of the pump also have a coefficient of thermal expansion. These coefficients of thermal expansion may differ depending on the material. Therefore, if the various components are made of different materials, the coefficients of thermal expansion may differ.

[0054] In some embodiments, temperature changes may affect the thermal expansion or contraction of the fluid and / or one or more components of the infusion pump. For example, but not limited to, a rise in temperature may cause an increase in the diameter of the reservoir / syringe 430 (this is illustrative only; see Figure 4). This may be because the relative thermal expansion of the syringe compared to the fluid determines whether the fluid is delivered or retracted. Thus, this may then cause any fluid / insulin in the cannula 450 to flow back towards the reservoir 430. In this case, the volume of fluid insulin is retracted into the reservoir. Thus, a subsequent delivery request by the processing logic 400 may only deliver this retracted volume to the user. Thus, the volume of fluid / insulin (retracted volume) is not delivered to the user without a request or grasp by the user. Another embodiment involves a decrease in temperature. In some embodiments, a decrease in temperature may reduce the diameter of the reservoir 430, causing the fluid insulin to flow into the cannula 450. Therefore, an unintended bolus volume is delivered to this user. In this case, the fluid insulin is delivered to the user without any request or awareness from the user.

[0055] Therefore, in the first embodiment, the user may receive less fluid insulin than necessary or requested, and thus may experience hyperglycemia. In the second embodiment, the user may receive more fluid insulin than necessary or requested, and thus may experience hypoglycemia. In either embodiment, the user receives a volume of fluid insulin that is not the same as the requested or programmed therapy, and is not notified of the difference.

[0056] In these embodiments, the reservoir is assumed to be cylindrical. The following is a mathematical model of the volume change of a cylinder (assuming a constant linear expansion coefficient α). This is a model for explanatory purposes. Additional mathematical models may be determined as follows to adapt to additional assumptions, e.g., shapes other than cylindrical, or syringes with movable plungers.

[0057]

number

[0058] This assumes that αΔT << 1,

[0059]

number

[0060] It can be simplified to this.

[0061] Therefore, linear expansion coefficient

[0062] [ka]

[0063] For polypropylene, a material having the following properties, when the temperature changes from 30°C to 10°C, the volume change of a cylindrical object made of polypropylene is:

[0064]

number

[0065] This is the result.

[0066] The inherent volume change of water from 30°C to 10°C is approximately 0.40%. The difference between the two (approximately 0.12%) when applied to a 3cc syringe or reservoir is approximately 3.6 μL. However, in addition, the syringe plunger may move in response to thermal expansion, depending on the plunger material and the relationship of the syringe in the pump (e.g., the design of the syringe holder in the pump).

[0067] Therefore, it may be desirable to minimize the effect of temperature on fluid delivery. Accordingly, it is desirable to limit or minimize and / or characterize the thermal expansion of one or more components of the fluid and / or injection pump. Systems, methods, and apparatus described for minimizing the effect of temperature on the thermal expansion of one or more components of the fluid and / or injection pump may include one or more of the following exemplary embodiments.

[0068] In some embodiments, the selection of a material having a predictable and favorable coefficient of thermal expansion may minimize potential under- and over-delivery of the fluid, as discussed above. In some embodiments, the syringe material may be selected to match, for example, the thermal expansion of the fluid. For example, the linear coefficient of expansion of water at about 20°C is approximately

[0069]

number

[0070] That is the case.

[0071] Therefore, the syringe material may be selected to have a coefficient of expansion close to this value. For example, a mixture of polycarbonate and acrylonitrile butadiene styrene (also known as "ABS") can be used to match the thermal expansion coefficient of the fluid. In some embodiments, other plastics, such as polycarbonate but not limited to it, may have a coefficient of expansion close to such that the volume delivered by the syringe pump due to the expected temperature change is minimal and / or acceptable. In some embodiments, the selected plastic or material may be matched to the gradient of the thermal expansion of the fluid.

[0072] In some embodiments, the material of the plunger and / or plunger rod may be selected to compensate for temperature changes in a thermal differential manner. In some embodiments, the material for the syringe, plunger, and plunger rod may be selected to compensate for temperature changes in a thermal differential manner. Also, or in addition, in some embodiments, the material of one or more components of the drive system or any other components of the injection pump may be selected to compensate for temperature changes in a thermal differential manner.

[0073] In some embodiments, the material for any one or more injection pump components may be selected to have an opposite thermal coefficient or thermal compensating material in order to minimize the effect of thermal expansion with temperature. For example, at temperatures higher than which the injection pump syringe expands, the fluid flow may be negative. In some embodiments, at least one component of the drive system may have a negative thermal constant and therefore an opposite thermal coefficient. Thus, the syringe does not experience a volume change in response to rising temperature.

[0074] In some embodiments, the use of a material that can undergo a phase change during temperature change events can minimize the effect of temperature differential / change on the injection pump. For example, in some embodiments, the plunger may contain a predetermined volume of wax, and therefore, as the temperature rises, its length or position may increase due to the phase change of the wax. Additional wax features may be added in some embodiments to prevent flow. In some embodiments, wax features may be added to move the plunger forward by a (predetermined) distance such that the resulting volume change is equal to the square root of the plunger's diameter. Thus, in some embodiments, the use of a material that undergoes a phase change in response to temperature / temperature change / differentiation may be used to compensate for changes in the syringe volume caused by temperature changes. In some embodiments, a material that undergoes a phase change in response to temperature changes may absorb the energy of thermal differential, and therefore, for example, if the temperature is rising rather than the temperature rise of the injection pump, the wax or other phase-changing material may melt the wax phase-changing material and thus act as an energy sink, absorbing heat.

[0075] In some embodiments, the syringe may be constrained so that the plunger is advanced or withdrawn by temperature changes, compensating for changes in the syringe's volume. For example, in some embodiments, the syringe may be supported in a metal case, and the metal that may be used may include, but is not limited to, steel, aluminum, and / or FeNi36, also known as INVAR®, as well as any metal having a low coefficient of thermal expansion. The plunger may be made of a material having a high coefficient of thermal expansion. Thus, in this embodiment, as the diameter of the syringe barrel decreases, the syringe plunger is withdrawn by the decrease in temperature. Thus, these effects may be balanced so that the total volume change is minimized.

[0076] (Characterization and control compensation) In some embodiments, it may be considered to characterize the effect of temperature changes on the volume of fluid delivered by the injection device. In this embodiment, the pump may be subject to temperature fluctuations (i.e., both positive and negative), and the corresponding response by the injection pump may be recorded. Characterization may include, but is not limited to, the rate of change (i.e., whether it is 1 degree Celsius / minute, positive or negative, etc.), the total temperature fluctuation (e.g., 10 degrees Celsius, 5 degrees Celsius, etc.), and / or the position of the syringe plunger.

[0077] The injection pump may include one or more devices and / or components and / or systems that determine the temperature. In some embodiments, the injection pump may include one or more thermistors or other temperature sensors that determine the temperature. However, in other embodiments, various methods and / or devices and / or systems that directly or indirectly determine the temperature may be used, including but not limited to one or more of at least one resistance temperature device (RTD) and / or at least one non-contact infrared device (non-contact IR). The location of one or more thermistors and / or temperature-determining devices may vary. The location of one or more thermistors and / or temperature-determining devices may include, but not limited to, being printed on the drive screw, any location on the drive system, the syringe barrel, the plunger, and / or on the printed circuit board, including but not limited to being printed on the syringe barrel. In various embodiments, the location of one or more thermistors and / or temperature-determining devices may be any location away from the heat source, which may result in potentially erroneous readings. In some embodiments, one or more thermistors may determine the temperature of one or more locations, including but not limited to the inside of the syringe, the outside of the syringe, the inside of the pump, and / or the outside of the pump. Various controls may be determined based on a temperature model at any one or more of these locations. Thus, in some embodiments, characterization may be performed by taking temperature readings both inside and outside the syringe. In other embodiments, characterization may be performed by taking temperature readings from both the outside and inside of the pump. In various embodiments, one or more thermistors and / or temperature determining devices are preferably placed for user use at the same locations on the pump where they were during characterization.

[0078] In some embodiments, characterization may be completed by measuring the volume of the delivered fluid as a function of temperature. In some embodiments, this may be achieved by using a thermal chamber and an injection set / cannula connected to a reservoir / syringe that delivers the fluid to a precise scale. However, in other embodiments, this may be completed by using a thermal chamber and an injection set cannula connected to a reservoir / syringe that delivers the fluid, and then determining the position of the plunger inside the reservoir to determine the total volume of the delivered fluid.

[0079] In some embodiments, in practice, the temperature of the pump (at one or more locations and / or taken by one or more thermistors) may be measured, and the target position of the plunger may vary as a function of temperature to compensate for the thermal expansion of the syringe and / or plunger. The thermal expansion readings may be determined by referring to characterized data, as discussed above. Thus, in some embodiments, the target position may be modified based on a reference table or function approximation of the volume change of the syringe with temperature.

[0080] In some embodiments, the injection pump delivers fluid as base or bolus delivery, and / or variations thereof. Base delivery is a programmed rate or volume / time. The injection pump delivers a volume of fluid at a predetermined interval over a predetermined duration. The injection pump may also deliver bolus volumes. A bolus is a requested volume of fluid delivered immediately, i.e., when the request is made. One embodiment of the bolus and base delivery method is described in International Patent Application PCT / US2009 / 060158, titled Infusion Pump Assembly, filed on 9 October 2009, currently published as Patent Application Publication WO 2010 / 042814 (Agent Reference Number F51WO), published on 15 April 2010, and in U.S. Patent Application 12 / 249,882, titled Infusion Pump Assembly, filed on 10 October 2008, currently published as U.S. Patent Application Publication US-2010-0094222 (Agent Reference Number F51), published on 15 April 2010, both of which are incorporated herein by reference in their entirety. Furthermore, in some embodiments, for example, as described in U.S. Patent No. 7,498,563 (Agent's Reference Number D78), issued March 3, 2009, entitled Optical Displacement Sensor for Infusion Devices, the injection pump may determine the distance the plunger must travel to deliver a volume of fluid, such as a base volume or bolus volume. Thus, in some embodiments of the injection pump system, the injection pump may use an optical displacement sensor to determine the distance the plunger has traveled during delivery. In some embodiments, the injection pump determines the number of motor encoder counts per delivery to confirm the movement of the plunger.

[0081] However, in various embodiments, the delivery method includes determining the distance the plunger should travel (which may be called the target plunger position) in order to deliver a desired / target volume. As discussed above, this may be done by determining the number of motor encoder steps, or in other embodiments, by another method. In any case, the injection pump makes the determination of the plunger distance travel.

[0082] One embodiment of the characterization and control compensation method is as follows: The first step may be to characterize the volume delivered as a temperature change. This volume may be a function of the amount of fluid contained in the syringe (let's call it V) due to variations in the thermal expansion properties of plastics and liquids / fluids, which is also a function of temperature (let's call it T). The function β(T) is given by the following equation

[0083]

number

[0084] As can be seen, the volume change is experimentally correlated with the temperature change.

[0085] The coefficient β(T) may be found as a function of temperature (as shown above), or it may be approximated as a constant β(T,x) that is possibly a function of both temperature and plunger position.

[0086] Next, the target plunger position can be determined and adjusted. The target position x is given by the following formula:

[0087]

number

[0088] It may be adjusted based on the following formula, where D is the plunger diameter.

[0089] [ka]

[0090] Substituting this (letting x=0 when the plunger reaches its end and pushes out all the fluid in the syringe), the relationship is:

number

[0091] In various embodiments, this compensation may be carried out in different ways, including, but not limited to, the following. In some embodiments, compensation may be carried out by delivering based on an interval that may be more frequent than the basic delivery interval, for example, once every three minutes, but not limited to that, while in other embodiments it may be more frequent or less frequent. Furthermore, the syringe position may be adjusted based on temperature changes to maintain a zero net volume delivered between regular deliveries, e.g., basal and / or bolus deliveries. In some embodiments, this may be used for a low basal rate, where the thermally driven volume may exceed the regularly scheduled basal deliveries. However, in some embodiments, this may require reversing the syringe direction to prevent delivery.

[0092] Another embodiment may include a step of applying a correction when the fluid / insulin is scheduled for delivery. Thus, the target plunger position may be corrected based on the measured temperature change and the estimated thermally driven volume delivery. In some of these embodiments, the correction may be limited so that the plunger is driven in only one direction.

[0093] In some embodiments, the modeling may differ, and assumptions may be made regarding both the length and diameter of the syringe. In addition, assumptions may be made regarding the effect of temperature on the coefficient of thermal expansion of one or more components of the injection pump, including but not limited to the drive system, plunger, plunger rod, injection pump housing, and cannula.

[0094] In some embodiments, the step of adjusting the plunger target may include adjusting the target to be closer to or further away from the syringe outlet. In some embodiments, plunger advancement may be modified. In other embodiments, the plunger may be driven backward to compensate for temperature. However, in some embodiments, depending on the injection pump, it may be desirable to limit the adjustment to be closer to the syringe outlet. This may be due to potential backlash.

[0095] In some embodiments, a temperature-dependent base rate may be pre-programmed to the pump for temperature compensation. In these embodiments, the pump processor receives data from at least one temperature sensor. If the temperature data indicates that the temperature or rate of change of temperature is such that adjustment should be made, the processor may signal to modify the pre-programmed base rate. In some embodiments, this modification may be an addition or a decrease in the base rate by a predetermined percentage, e.g., a 30% increase or a 15% decrease. Of course, these are merely embodiments, and in these embodiments, the predetermined modification may be determined to be different from those described.

[0096] In some embodiments, the injection pump may include at least one temperature sensor and at least one optical sensor. In some embodiments, the optical sensor may be used to determine that the plunger has advanced. In some embodiments, the distance of advancement may also be determined. In some embodiments, a small reflective optical sensor (hereinafter referred to as "optical sensor") is used that conforms to the shape factor of the injection pump hardware. The optical sensor has a sensing range that overlaps with the plunger displacement. In exemplary embodiments, Sharp Any optical sensor may be used, including but not limited to the Sharp GP2S60, manufactured by Sharp Electronics Corporation, a U.S. subsidiary of Corporation (Osaka, Japan). This optical sensor contains an infrared light-emitting diode and an infrared sensing detector in a single package. Light from the emitter is unfocused and bounces off the sensing surface, a portion of which is returned to the detector, resulting in a sensed light intensity that varies as a function of distance / angle to the reflector. In some embodiments, the sensor is arranged such that the reflective surface is a plunger.

[0097] In some embodiments, an optical sensor may be used to determine the fluid level in the syringe / reservoir. This information may be used to determine whether the plunger rod has advanced. Along with temperature sensor information, this may provide additional data / information to determine temperature-dependent changes.

[0098] All of these are incorporated herein by reference: U.S. Patent No. 7,498,563 (Agent Reference Number D78), issued on March 3, 2009, entitled Optical Displacement Sensor for Infusion Devices, and Infusion Pump, filed on October 9, 2009. In some embodiments of an infusion pump system, including embodiments disclosed and described in international application PCT / US2009 / 060158 titled "Assembly," now published international publication WO2010 / 042814 (agency number F51WO) on April 15, 2010, and U.S. Patent Application 12 / 249,882, filed on October 10, 2008, titled "Infusion Pump Assembly," now published U.S. Patent Application Publication US-2010-0094222 (agency number F51) on April 15, 2010, the infusion pump may include an optical displacement sensor. This sensor may be used to determine whether the plunger rod has advanced forward or backward, and the distance of the advance. This displacement information may be used, along with information from one or more temperature sensors, to determine the effect of temperature changes on the plunger. In turn, this decision may increase the accuracy of the control used to compensate for temperature changes. This may include, but is not limited to, reducing the amount of fluid delivered by the sensed forward movement and / or increasing the amount of fluid delivered by the sensed backward movement. In either case, the increase and / or decrease in the base rate and / or amount and / or bolus amount (e.g., by a certain percentage of the intended amount) is by a predetermined amount and for a predetermined time.

[0099] In some embodiments, the infusion pump system may include a system and / or method for adjusting the basal rate and / or bolus volume based on temperature changes. Thus, in various embodiments, if the system determines that an upward or downward threshold temperature change has occurred, the system may automatically and / or, upon user request and / or confirmation, enter a mode having a limited period, e.g., a uniform pre-revised limited period, e.g., 20 minutes, and / or, in some embodiments, the mode may continue until the temperature change threshold is no longer applicable. In some embodiments, for example, if a decreasing temperature gradient is the primary concern, the infusion pump processor may be pre-programmed into a “decreasing gradient” mode, and the infusion pump may intentionally under-deliver in this mode, i.e., in automatic rate reduction of the basal rate, and in some embodiments, the bolus may also be formulated to compensate for the expected additional delivery of fluid. As discussed above, the determination of the rate change of insulin delivery may depend on the characterization of the infusion pump.

[0100] Subsequently, in some embodiments, for example, if a rising temperature gradient is the primary concern, the injection pump processor may be pre-programmed in “rising temperature gradient” mode, and the injection pump may intentionally over-deliver, i.e., in the automatic rate increase of the base rate, and in some embodiments, the bolus may also be formulated to compensate for the expected additional delivery of fluid. As discussed above, the determination of the rate change may depend on the characterization of the injection pump.

[0101] (Closed loop temperature compensation) For the purposes of this explanation, the term “advance” refers to the movement of the plunger within the syringe or reservoir body. Advance is not limited to movement in a specific direction. A syringe has an outlet end, which is the end of the syringe from which the fluid moves outward.

[0102] In some embodiments, the system may include one or more devices and / or sensors that determine the effect of temperature on the syringe / plunger and / or the effect of fluid delivery toward or away from the user / cannula. These devices and / or sensors may include, but are not limited to, one or more flow sensors, one or more occlusion devices and / or one or more binary valves and / or one or more strain beams or sensors and / or one or more optical sensors and / or one or more temperature sensors and / or one or more ultrasonic range sensors and / or one or more potentiometers and / or one or more rotor encoders and / or one or more linear encoders.

[0103] With respect to the optical sensor, in some embodiments, the injection pump may include at least one temperature sensor and at least one optical sensor. In some embodiments, the optical sensor may be used to determine that the plunger has advanced. In some embodiments, the distance of advancement may also be determined. In some embodiments, a small reflective optical sensor (hereinafter referred to as the "optical sensor") is used that fits the shape factor of the injection pump hardware. In various embodiments, the optical sensor has a sensing range that overlaps with the plunger displacement. In various embodiments, any optical sensor may be used, including, but not limited to, the Sharp GP2S60, Sharp GP2S700, and Sharp GP2A240LC, all of which are manufactured by Sharp Electronics Corporation, a U.S. subsidiary of Sharp Corporation (Osaka, Japan). This optical sensor contains an infrared light-emitting diode and an infrared sensing detector in a single package. Light from the emitter is unfocused and bounces off the sensing surface, a portion of which is returned to the detector, resulting in a sensed light intensity that changes as a function of distance / angle to the reflector. In some embodiments, the sensor is positioned such that the reflective surface is the plunger.

[0104] In some embodiments, an optical sensor may be used to determine the fluid level in the syringe / reservoir. This information may be used to determine whether the plunger rod has advanced. Along with temperature sensor information, this may provide additional data / information to determine temperature-dependent changes.

[0105] In some embodiments of the injection pump system, the injection pump may include an optical displacement sensor. This sensor may be used to determine whether the plunger rod has moved forward (towards the syringe outlet) or backward (away from the syringe outlet), and the distance of the movement. This displacement information may be used, along with information from one or more temperature sensors, to determine the effect of temperature changes on the plunger. This determination may then increase the accuracy of the control used to compensate for the temperature changes. This may include, but is not limited to, reducing the amount of fluid delivered by the sensed forward movement (i.e., reducing the volume of fluid intended to be delivered, i.e., the base rate, or the volume of fluid requested to be delivered, i.e., the bolus volume), and / or increasing the amount of fluid delivered by the sensed backward movement.

[0106] In some embodiments, the infusion pump may include an outlet valve and / or a occluder. Thus, in these embodiments, the infusion pump includes at least one device that prevents the delivery of fluid from the syringe to the cannula and / or from the cannula to the user. In some embodiments, at least one temperature sensor sends a signal to a processor, and the device is activated when the processor determines that a temperature change meets a threshold, i.e., the temperature change is large enough to cause a temperature-induced change in delivery. In some embodiments, this may activate an occluder and / or outlet valve to prevent fluid from flowing into and / or out of the syringe and / or cannula. In some embodiments, the occluder and / or outlet valve device is deactivated when the processor determines that the temperature change no longer meets a threshold, i.e., the temperature change is no longer large enough to cause a temperature-induced change in delivery. In some embodiments, this may deactivate the occluder and / or outlet valve, allowing fluid to flow out of the syringe and / or to the cannula and / or to the user. Again, as discussed above, in some embodiments, the plunger target may be adjusted in response to information from one or more temperature sensors.

[0107] In some embodiments, the occluder / outlet valve may be closed during intervals when the injection pump is not actively delivering fluid to prevent accidental inflow or outflow of fluid into or from the syringe / reservoir due to temperature changes. During these intervals when the injection pump is not actively delivering fluid, at least one temperature sensor may continue to transmit a temperature signal to the processor. This information may be used by the control system to determine whether and how to perform the "next delivery" of fluid, i.e., modify the next plunger target. Thus, when the "next delivery" is performed, the occluder / outlet valve may be opened and fluid is delivered.

[0108] Therefore, in these embodiments, the blocker / outlet valve may primarily act to prevent spontaneous, unintended fluid flow that may be caused by temperature changes. The control system may adjust the volume delivery, i.e., the plunger target, based on the temperature change, so that the volume of fluid delivered compensates for the temperature change.

[0109] In some embodiments, the injection pump may include a flexible component. In some embodiments, the flexible component may tolerate differences in the volume change of the syringe / reservoir while maintaining a pressure constant. Therefore, in these embodiments, since there will be no pressure accumulated from temperature changes, controller compensation may not be required to compensate for temperature changes when the occluder / outlet valve is open.

[0110] In some embodiments, once a threshold temperature change is determined, the occluder / outlet valve may be closed, and the plunger rod may be allowed to float, i.e., the plunger rod may be engaged with and disengaged from the drive system. Thus, pressure changes allow the plunger to float, achieve equilibrium, and therefore adjust in response to temperature changes without requiring controller compensation.

[0111] In some embodiments, the injection pump may include, but is not limited to, at least one flow sensor located in the outlet flow path. The flow sensor may detect the flow of fluid. This information may correlate with a delivery command to determine whether the delivered fluid is requested and / or a proper delivery. In some embodiments, if flow is detected and it is determined that the delivered fluid is not requested and / or a proper delivery, the blocker and / or outlet valve may be closed. Thus, in some embodiments, the flow sensor may determine inward or outward fluid flow, and if this is not an expected event, the injection pump may activate at least one mechanism, including, but not limited to, a blocker and / or valve, to prevent continued fluid flow. In addition, flow information may be used to determine the amount or volume of fluid delivered or flowed inward, and this information may be used to modify the plunger target during the next scheduled or requested delivery (e.g., foundation or bolus), or in some embodiments, to modify the delivery schedule. In some embodiments, this may be completed without user interaction. In some embodiments, an alert may be sent to the user, who must accept the proposed process or action and mitigate any under- or over-delivery of the fluid.

[0112] In some embodiments, the injection pump may include one or more optical sensors. These sensors may be located within the injection pump to determine the fluid level in the syringe / reservoir. One or more optical sensors may determine the fluid level before and after the processor signals the drive system to advance the plunger. Thus, the volume difference may be determined before and after the plunger is advanced. However, in some embodiments, at least one optical sensor may collect data at a predetermined interval regardless of whether the drive system is activated or not. Thus, at least one optical sensor may collect information to determine when and whether the plunger has advanced and / or when and whether the fluid has been delivered or drawn in. Thus, at least one optical sensor may collect data for the processor to determine when an unsolicited event has occurred. The processor may correlate this information with at least one temperature sensor to determine whether the injection pump is experiencing temperature-related influences. In some embodiments, the processor may alert the user. In some embodiments, information may be used, for example, to cause a control algorithm to compensate for the effects of temperature changes using various embodiments discussed herein, but not limited to.

[0113] In some embodiments, a strain beam may be used to identify when the plunger moves away from the syringe outlet. In these embodiments, the strain beam may be positioned relative to the plunger rod so that it senses strain when the plunger rod begins to move away from the syringe outlet. In some embodiments of the injection pump system, the injection pump includes a strain beam that may be used to detect and / or identify blockages. The strain beam and method may be similar to those described in several embodiments, which are incorporated herein by reference in their entirety by U.S. Patent Application No. 12 / 249,882, filed October 10, 2008, titled Infusion Pump Assembly, U.S. Patent Publication No. US-2010-0094222 (Agent Reference Number F51), published April 15, 2010, and International Application PCT / US2009 / 060158, filed October 9, 2009, also titled Infusion Pump Assembly, International Publication No. WO2010042814 (Agent Reference Number F51WO), published April 15, 2010. However, together with at least one temperature sensor, the strain beam may determine whether a particular temperature change has resulted in plunger movement. If plunger movement is detected by a temperature change, the injection pump may alert the user. In some embodiments, the system may correlate the change in strain with the change in temperature.

[0114] (temperature maintenance) As described above, there may be a desire to maintain the temperature of the injection pump to avoid any consequences from temperature changes. In some embodiments, one or more different devices and / or systems may be employed to maintain the temperature of the injection pump in order to minimize or prevent the above-mentioned effects of temperature changes on the injection pump and fluid delivery.

[0115] In some embodiments, the injection pump includes a heating device. The heating device may receive instructions from a processor. The heating device may be located inside or on top of the injection pump, but in some embodiments, the heating device is located inside the injection pump housing. In some embodiments, the heating device is powered by an internal power supply or battery of the injection pump. However, in some embodiments, the power supply may be external to the injection pump.

[0116] The heating source may be any desired heating source, but in exemplary embodiments, the heating source may be a KAPTON® (polyimide film) heater kit, available from omega.com® under part number KH-KIT-EFH-15001. In some embodiments, at least one temperature sensor is located inside or above the injection pump. At least one temperature sensor may communicate information to a processor. Based on the temperature sensor data, the processor may act as a thermostat, supplying power to the heating source to maintain the temperature inside the injection pump at a desired temperature. In some embodiments, the desired temperature may be between 15 and 30 degrees Celsius, but in other embodiments, the maintenance temperature may vary. In some embodiments, it may be desirable to maintain a higher temperature.

[0117] In some embodiments, the syringe / reservoir may be contained within a metal case in the injection pump. The metal case may increase heat conduction between the heating element and the syringe / reservoir.

[0118] In some embodiments, at least one heating element may be located in one or more locations inside the injection pump, one or more of which may be selected to maintain the temperature of one or more components of the injection pump, including but not limited to the syringe, fluid, plunger, housing, plunger rod, and / or drive system.

[0119] In some embodiments, at least one heating element may also extend the power supply and / or battery life in the injection pump. Maintaining a temperature of approximately 35 degrees Celsius may be beneficial for battery life and / or performance.

[0120] In some embodiments, it may be desirable to use the user's body as a heat sink and to mount the injection pump in close proximity to the user's skin. This may be achieved using a variety of devices and apparatus, including but not limited to one or more of the following:

[0121] For example, a Velcro® system, such as but not limited to those provided by VELCRO® USA Inc. (Manchester, NH), may be used to allow for easy attachment / removal of the infusion pump from the user. Therefore, an adhesive patch may be attached to the user's skin and may include outward-facing hook or loop surfaces. In addition, the surface of the infusion pump 114 may include complementary hook or loop surfaces. Depending on the separation resistance of the specific type of Velcro® system employed, the strength of the hook and loop connection may be stronger than the strength of the adhesive to the skin connection. Therefore, various hook and loop surface patterns may be used to adjust the strength of the hook and loop connection.

[0122] Furthermore, referring to Figures 10A-10E, five embodiments of such hook and loop surface patterns are shown. For illustrative purposes, assume that one surface of an injection pump housing is covered with the “loop” material. Thus, the strength of the hook and loop connection may be adjusted by varying the pattern (i.e., amount) of the “hook” material present on the surface of the adhesive patch. Embodiments of such patterns may include, but are not limited to, a single outer circle 220 of the “hook” material (as shown in Figure 10A), multiple concentric circles 222, 224 of the “hook” material (as shown in Figure 10B), multiple radial spokes 226 of the “hook” material (as shown in Figure 10C), multiple radial spokes 228 of the “hook” material combined with a single outer circle 230 of the “hook” material (as shown in Figure 10D), and multiple radial spokes 232 of the “hook” material combined with multiple concentric circles 234, 236 of the “hook” material (as shown in Figure 10E).

[0123] In another embodiment, a holder, pouch, bag, container, or other type of housing (generally referred to as “holder”) may be sized to accommodate the injection pump. In some embodiments, the holder may be constructed to include multiple layers, including but not limited to one or more insulating layers. In some embodiments, one or more of the layers may include a fabric, which provides a cooling effect when wet and refrigerated or frozen. This layer may be desired in warmer weather or conditions, where the user’s injection pump may be exposed to sunlight or a warm environment. In some embodiments, one or more of the layers may be a highly absorbent material. In some embodiments, the holder may include one or more cans of isopropyl alcohol, which, once deployed, may be absorbed by the highly absorbent material of the holder, providing evaporative cooling to the injection pump. In various embodiments, the holder may include alternative and / or additional methods, systems, and / or devices for cooling the injection pump.

[0124] In some embodiments, the holder may include one or more temperature measuring devices and / or temperature sensors that may transmit information to the injection pump and / or controller. One or more temperature sensors may communicate the temperature of the holder, deploy one or more cans of alcohol, and / or warn the injection pump / user / controller, and / or turn on a heating source based on the temperature sensors. In some embodiments, heating and / or cooling may be induced by reaching a threshold temperature change. Thus, in some embodiments, the holder may provide a closed-loop system to maintain the temperature for the injection pump.

[0125] Referring here to Figure 11, some embodiments of the holder 500 include an outer layer 502, an inner layer 504, and an inner pocket 506. The pocket 506 may include additional cushioning or insulation to protect the injection pump from external forces and / or temperature changes. The holder 500 may include fasteners along the front, top, or sides. In some embodiments, the holder 500 may include a pull-down flap (not shown) on the front to expose the screen and / or input assembly (e.g., buttons, sliders, and / or jog wheels, but not limited to those). In some embodiments, the flap may be secured and closed using a Velcro® system. In other embodiments, the flap may be secured using any other fastening system, including but not limited to snaps, buttons, magnetic closures, and zippers.

[0126] In some embodiments, the holder 500 may be attached to a strap 508 designed to be attached to the user (see, for example, Figure 12). However, in various embodiments, the strap 508 may be elastic and / or adjustable and may include at least one closure device.

[0127] Although shown in Figure 12 as being mounted around the central part of user 510, holder 500 may be mounted anywhere the user desires.

[0128] Referring here to Figure 13, a rear embodiment of the holder 500 is shown. In some embodiments, the holder may include a clip 512, which may be called a “belt clip” or another type of clip, configured to cover, secure, and detachably fit onto a belt, handle, piece of clothing, or other object. In some embodiments, the holder 500 may also include an opening 514 through which pipes 516 can be fitted. In some embodiments, an injection pump (not shown) is contained within the holder 500, and the holder may be mounted close to a user insertion site (not shown) so that the smallest pipes 516 are exposed to the external temperature. Thus, embodiments of the holder 500 including an opening 514 for pipes may be beneficial for maintaining the temperature of the pipes 516 and / or the fluid within the pipes.

[0129] In some embodiments, a plastic material, such as Press n'Seal, or another material with similar properties, may be used to attach and maintain the infusion pump against the user's body. In other embodiments, a cuff and band fitted to, for example, the user's leg, midsection, or arm may include a pouch for the infusion pump. In other embodiments, the infusion pump may be held in place against the skin through an inner pocket, bra pocket, etc.

[0130] Various embodiments for maintaining the temperature of an infusion pump using both the user's body temperature and / or a heating element are described herein. However, additional devices and apparatus are within the scope of the present invention. Furthermore, various methods, systems, and apparatus for maintaining the temperature of an infusion pump may include at least one temperature sensor.

[0131] (Insulin temperature) This specification describes various methods, systems, devices, and / or apparatus for maintaining the temperature of an infusion pump. In at least some of these embodiments, maintaining the temperature of the injectable fluid / insulin is inherent. It is well known that insulin manufacturers recommend that the insulin temperature not exceed high or low temperatures. In addition, once the vial has been used, it may be beneficial to maintain rapid action (e.g., HUMALOG®, NOVOLOG®) at room temperature / ambient temperature (e.g., between 59 and 86 degrees Fahrenheit), and thus manufacturers recommend storing insulin in a refrigerated area, for example, between 36 and 46 degrees Fahrenheit, until the vial is used. For this purpose, it is recommended that the vial be stored at room temperature.

[0132] Since insulin may lose effectiveness or become ineffective once it reaches a non-recommended temperature, it can be beneficial for users to know whether their insulin has been stored properly, whether during transport, in a refrigerator, or during use.

[0133] Referring to Figure 14, in one embodiment, a patch thermometer 520 may be placed on the fluid vial 522, and in some embodiments, on the insulin vial. The thermometer may inform the user of the current temperature of the vial. In some embodiments, the temperature may be shown as various shades of red and blue indicating various temperatures ranging from high to low. In some embodiments, once the temperature reaches the highest or lowest temperature (which may be predetermined, and in some embodiments, 35°F and 87°F, respectively), the thermometer becomes irreversible, thus instantly indicating to the user that the insulin has reached its highest or lowest temperature.

[0134] Any adhesive thermometer may be used, including non-reversible temperature labels such as Non-Reversible Temperature Labels, 3 Temperature Ranges, or other similar temperature labels, available from omega.com®. As discussed above, in some embodiments, a reversible temperature label may be used, or a label having both reversible and irreversible components may be used.

[0135] (Atmospheric pressure) A drop in atmospheric pressure can result in unintended and / or unplanned and / or unrequested delivery of fluid from the reservoir in the injection pump to the user. A drop in pressure can also create air that may be present in the reservoir or dissolved in the fluid within the reservoir. Some embodiments of the infusion pumps that may be affected are similar to syringe infusion pumps, and are shown in Figures 1A–4, all of which are incorporated herein by reference, and include, but are not limited to, the various embodiments shown and described in U.S. Patent No. 7,498,563 (Agent No. D78), issued on 3 March 2009 and titled Optical Displacement Sensor for Infusion Devices; U.S. Patent No. 7,306,578 (Agent No. C54), issued on 11 December 2007 and titled Loading Mechanism for Infusion Pump; and International Application PCT / US2009 / 060158, filed on 9 October 2009 and titled Infusion Pump Assembly; and currently published on April 15, 2010, Patent Application Publication WO 2010 / 042814 (Agent No. F51WO). Therefore, if the syringe infusion pump experiences a drop in atmospheric pressure during operation, an unintended bolus may be delivered to the user. This also raises safety concerns because the unintended bolus may not be known to the user. Consequently, the user may experience an over-delivery event, which may result in a hypoglycemic event, in embodiments including an insulin pump.

[0136] An increase in atmospheric pressure can result in unintended and / or unplanned suction of fluid from the tubes / cannulas towards the reservoir in the infusion pump. Some embodiments of the infusion pumps that may be affected are similar to syringe infusion pumps, including, but not limited to, the various embodiments shown and described in Figures 1A–4, as well as U.S. Patent No. 7,498,563 (D78), issued on March 3, 2009, entitled Optical Displacement Sensor for Infusion Devices; U.S. Patent No. 7,306,578 (C54), issued on December 11, 2007, entitled Loading Mechanism for Infusion Pump; and International Application PCT / US2009 / 060158, filed on October 9, 2009, entitled Infusion Pump Assembly, and currently published as Patent Application Publication WO 2010 / 042814 (F51WO), published on April 15, 2010. Therefore, if the syringe infusion pump is subjected to an increase in atmospheric pressure during operation, unintended aspiration of fluid from the tubes / cannulas may occur, which may result in delivering a smaller volume to the user than intended. This also raises safety concerns, as the aspiration volume may not be known to the user. Consequently, the user may experience under-delivery events, which may result in hyperglycemic events in embodiments involving insulin pumps.

[0137] In some embodiments, the syringe infusion pump and / or remote controller for the syringe infusion pump may include a pressure sensor, which in some embodiments may be an altimeter, similar to those known in the art. The terms “pressure sensor” and “altimeter” may be used interchangeably herein. The altimeter may communicate with a pump processor, and therefore data from the altimeter may be used by the pump processor. In some embodiments, the processor may include a predetermined rate of change and / or atmospheric pressure threshold (rise or fall) which may induce at least one response from the infusion pump.

[0138] In some embodiments, the response may include notification to the user. Thus, the infusion pump and / or remote controller may notify and / or alarm and / or warn the user when the altimeter transmits data indicating an increase and / or decrease in atmospheric pressure that has triggered a threshold. In some embodiments, the processor may recognize potential events, such as aircraft takeoff, aircraft descent, or movement to / from high altitude to low altitude, from the altimeter data. These recognized events may, in some embodiments, trigger at least one command from the user, for example, the pump and / or controller may warn and / or alert the user by questions, including, but not limited to, "Aircraft taking off?" and / or "Aircraft descending?". Upon confirmation by the user, the pump may suggest that the user disconnect from the cannula, for example, by an audible and / or visual signal to the user, such as an alert and / or alarm. Subsequently, when the threshold "safe" altitude is reached and / or when altimeter data indicates that the user has been at an appropriate altitude for a predetermined period, the pump / controller may warn and / or alert the user to reconnect the cannula. Thus, in some embodiments, any potential adverse effects caused by atmospheric pressure changes may be minimized and / or mitigated and / or avoided by notification to the user, who then disconnects and / or reconnects as appropriate.

[0139] See also Figure 15, a method 600 for reducing atmospheric pressure is shown. In some embodiments, a pressure sensor / altimeter transmits data to a processor at predetermined intervals 602. If the altimeter data indicates a predetermined warning and / or alert threshold 604, the processor may warn and / or alert the user to disconnect from the cannula 606. If the altimeter indicates that a predetermined appropriate / safe threshold is met 608, the processor may warn and / or alert the user to reconnect to the cannula 610. However, until a predetermined appropriate threshold is met 608, the altimeter continues to transmit data to the processor at predetermined intervals 612.

[0140] In some embodiments, the altimeter may transmit data to the processor at predetermined intervals, which may be but not limited to every minute. In some embodiments, the frequency may be increased or decreased based on the altimeter data. For example, in some embodiments, if the aircraft takeoff is confirmed by the user, the altimeter may transmit data to the processor more frequently. In some embodiments, once the user reconnects, the altimeter may transmit data to the processor based on events entered by the user. For example, in some embodiments, if the user anticipates movement on an aircraft (movement on an aircraft is used merely as an example; in other embodiments, the event may be any event that may result in a change in atmospheric pressure), the user may select a menu option in the user interface on the pump and / or controller to indicate that the pump is put into "aircraft mode". This mode may also require the user to input additional information, such as the scheduled takeoff time and / or scheduled landing time. Thus, the pump and / or controller may modify the frequency of altimeter data communication based on the user input information. The user input information may also be used by the pump and / or controller to recognize changes in events via the readings from the altimeter. For example, the processor may recognize that if a decrease in atmospheric pressure is not predicted based on the user-entered takeoff time, the pump / controller may request further information from the user regarding the altered takeoff time. The user-entered event information may also be used by the processor to verify the altimeter's function and / or accuracy. For example, if the reading during takeoff is not as expected, even within pre-programmed error limits, this may indicate an altimeter malfunction, and the pump / controller may issue an alarm and / or warning. In some embodiments, the pump / controller may then warn the user to disconnect during takeoff and descent.

[0141] In some embodiments, data from an altimeter and / or pressure sensor may be used to modify the scheduled fluid delivery. Thus, the altimeter and / or pressure sensor may communicate with the injection pump processor. Sensed pressure changes in the positive or negative direction may be communicated to the processor. Accordingly, the processor may communicate with a controller to decrease or increase the rate of delivery of the injectable fluid. For example, the controller may increase or decrease any scheduled delivery by a predetermined rate over a predetermined period. In some embodiments, the injection pump may include modes or other pre-programmed delivery schedule modifiers to address situations in which the injection pump may receive an increase or decrease in pressure at which it may achieve fluid delivery. Modes may be selected by the user when the user is experiencing or planning to experience a pressure change event, such as, for example, flight in an aircraft. In some embodiments, the user may select a mode that may be referred to as "aircraft mode" (however, this is merely an embodiment of the name, and the term may be used to identify any pressure change event in various embodiments, and in various embodiments, it may not be limited to aircraft events), and in addition, may specify, for example, whether it is takeoff or landing. Accordingly, the injection pump may increase or decrease the delivery rate.

[0142] In some embodiments, if altimeter data indicates a pressure change event that could result in an unintentional / unintended increase or decrease in fluid delivery, and / or if the user indicates the same to the pump and / or controller, for example, via menu selection and / or manual input and / or voice recognition commands, one or more of the following, but not limited to them, the pump may enter "aircraft mode," which in some embodiments includes modifying the frequency of determining the plunger's location. In some embodiments, for example, as described above and / or in U.S. Patent No. 7,498,563 (Agent Reference Number D78), issued March 3, 2009, titled Optical Displacement Sensor for Infusion Devices, the infusion pump may include at least one sensor for determining the plunger's location. In some embodiments, this may be achieved by using the methods, apparatus, and systems described above and / or in U.S. Patent No. 7,498,563 (Agent Reference Number D78), issued March 3, 2009, entitled Optical Displacement Sensor for Infusion Devices, and in other embodiments, other sensors may be used to determine the movement or location of the plunger. However, in various embodiments, the frequency at which the sensor determines the plunger's position may vary in "aircraft mode". For example, in some embodiments, during normal operation, the infusion pump may determine the plunger's position before and after scheduled and / or requested deliveries. However, in some embodiments, in aircraft mode, to determine plunger movement that may not be due to scheduled and / or requested deliveries, the infusion pump may determine the volume of fluid drawn up or delivered due to a change in pressure event by modifying the frequency of sensor readings. Thus, when entering aircraft mode and / or when altimeter data induces the mode, the sensor may take readings at predetermined intervals, for example, every minute.In some embodiments, if the sensor reading indicates movement toward delivery or suction, the estimated volume of fluid being delivered or suctioned may be presented to the user. The user may then make appropriate changes to the treatment based on this information. However, in some embodiments, the sensed volume of delivered and / or suctioned fluid may be used by the processor to correct scheduled deliveries over a predetermined period. In some embodiments, the predetermined period may depend on many factors, including, but not limited to, the volume of fluid being corrected by the infusion pump.

[0143] Referring to the above description regarding temperature changes and mitigation, in some embodiments, when a pressure change threshold is met, the system may be automatically and / or manually put into a similar mode for sensing the plunger position. Thus, various methods, as described with respect to various embodiments relating to sensor frequency correction and downstream correction of delivery, may be used for pressure mitigation.

[0144] In some embodiments, the infusion pump may include at least one valve located downstream of the reservoir. In various embodiments, the valve may be located anywhere between the distal end of the reservoir and the cannula site, including but not limited to being incorporated into the infusion set itself, and including but not limited to being located in one or more of the following: in the tubing, in the cannula, and / or the distal end of the reservoir. In some embodiments, at least one valve may be a pressure / atmospheric compensation valve. In some embodiments, the valve may be one of those shown in Appendix A (available from The Lee Company (Westbrook, Connecticut, USA) (Lee 250 Zero Leak) The valve may be a micro check valve similar to Chek®, which is configured such that the valve remains completely closed by any higher pressure difference on the cannula side of the valve compared to the reservoir side of the valve (which may be called “downstream from the valve” and “upstream from the valve,” respectively), i.e., so that fluid cannot flow back into the reservoir when the valve is closed. In some embodiments, the outflow cracking pressure may be selected so that differential pressure related to altitude changes does not open the valve. For example, in some embodiments, the cracking pressure may be set to 5 PSI. Thus, in this embodiment, at sea level, the injection pump may be required to generate 5 PSI to induce flow. For example, during pressure drops such as those experienced during aircraft flight, the injection pump may be required to induce 1 PSI to induce flow due to a negative pressure bias of altitude change, for example. In some embodiments, fluid flow based solely on altitude change may be eliminated and / or reduced and / or mitigated. Thus, in these embodiments, the effects of pressure changes may be mitigated while the user is receiving intended and / or scheduled and / or requested therapeutic delivery.

[0145] (Bubble management) Bubbles and / or air dissolved in the fluid in a syringe reservoir, similar to those shown and described in U.S. Patent No. 7,498,563 (D78), issued on March 3, 2009, entitled Optical Displacement Sensor for Infusion Devices; U.S. Patent No. 7,306,578 (C54), issued on December 11, 2007, entitled Loading Mechanism for Infusion Pump; and International Application PCT / US2009 / 060158, filed on October 9, 2009, entitled Infusion Pump Assembly, and currently International Publication WO2010 / 042814 (F51WO), published on April 15, 2010, may affect fluid delivery. When bubbles and / or dissolved air in the fluid are degassed, they can displace, expand, and / or compress the fluid, which may affect delivery. In addition, bubbles can affect blockage detection in some embodiments of injection pumps. For example, in many injection pump systems, blockage detection is performed using a strain beam / strain gauge to detect the upstream pressure exerted from the plunger toward the strain beam. When the pressure reaches a threshold, blockage is determined and / or assumed by the system, and generally, a blockage alarm and / or warning is given to the user. However, this blockage detection system relies on the fluid in the reservoir being incompressible.

[0146] When the fluid in the reservoir contains at least one bubble, since air is compressible, the additional force in the reservoir due to the blockage should first compress the bubble before the force is exerted on the strain gauge. This may ultimately require the presence of further force to detect the blockage. Therefore, bubbles in the reservoir may contribute to a delay in blockage detection. Thus, for many reasons, including blockage detection, it may be desirable to minimize, mitigate, and / or eliminate bubbles and / or dissolved air in the fluid in the reservoir.

[0147] In addition, as the size of the bubbles increases, the bubbles can increase the fluid pressure in the reservoir. The increased fluid pressure in the reservoir may cause unintentional and / or unplanned delivery of the fluid (which in some embodiments is insulin).

[0148] (Reduces over-delivery caused by air) With regard to bubble reduction to minimize and / or eliminate unintentional and / or unplanned fluid delivery, in some embodiments, the three-way valve may be located downstream of the reservoir. Referring here to Figure 16, in some embodiments, both the active check valve 650 and the passive check valve 652 may be located downstream of the reservoir 654. In some embodiments, the active check valve 650 may be opened for intentional and / or planned and / or requested therapeutic delivery, but otherwise may remain closed. The passive check valve 652 may only be opened when sufficient pressure is exerted on the valve to overcome it. Thus, in some embodiments, when there is no intentional and / or planned and / or requested therapeutic delivery, the active valve 650 remains closed. This continues as long as the fluid pressure is not sufficient to overcome the passive check valve 652, and until it is sufficient, so that no fluid passes through either valve. However, in some cases, for example, the rising fluid pressure from a bubble may overcome the passive check valve 652 (i.e., overcome the cracking pressure of the passive check valve 652) and flow outside the pump (in various embodiments, the fluid flowing through the passive check valve 652 may flow anywhere desired except to the user). Thus, in this embodiment, only intended and / or planned and / or requested treatment delivery is performed, and otherwise, the rising fluid pressure may be mitigated through the use of the passive check valve 652 (unintended and / or planned fluid delivery may be avoided and / or mitigated and / or reduced).

[0149] (Minimizing bubbles) Bubbles can be introduced into the reservoir by various means, including but not limited to fluid degassing, due to various environmental factors. In some cases, the fluid may outgasse after being introduced into the reservoir. This may occur as a result of temperature. In some cases, for example, when insulin is used as the fluid, insulin below room temperature may undergo some degassing while reaching room temperature. Insulin that has been at room temperature for a relatively long period may not undergo as much degassing, and therefore insulin in this state may undergo the least or less degassing in the reservoir compared to insulin that is below room temperature when loaded into the reservoir.

[0150] Therefore, methods, systems, and apparatus for increasing the degassing of insulin and / or fluids before loading them into the reservoir may be desired. This can minimize the effects of degassing, i.e., the effects of air bubbles in the reservoir.

[0151] Referring here to Figure 17, in some embodiments, a filling adapter device 700 may be used to minimize the effects of degassing. In some embodiments, the filling adapter 700 may be a reusable filling adapter, while in other embodiments, the filling adapter 700 may be disposable. In some embodiments, the filling adapter 700 device may be connected to a vial 702 of the injectable fluid to be used while filling and / or partially filling a reservoir / syringe 704 with the injectable fluid, which is insulin (i.e., configured to be connected to and / or detachably attached to the vial). In some embodiments, the filling adapter 700 may be attached to and / or detachably attached to the vial 702 at the time of manufacture, while in some embodiments, the user may attach the filling adapter 700 at the time of use (in some of these embodiments, the filling adapter 700 may be detachably attached). Thus, in some embodiments, the vial 702 may be provided with the filling adapter 700, and in some embodiments, the reservoir 704 may be provided to the user with the filling adapter 700. In other embodiments, the filling adapter 700 may be a separate device from the vial 702 and / or reservoir 704. In some embodiments, the filling adapter 700 may further include a needle (not shown) for connecting fluid from the vial to the fluid path 712. In some embodiments, when the filling adapter 700 is attached to the vial 702, the needle is...

[0152] The device may include a heat exchanger which includes a heating element 706 and a fluid path 712, which may be, for example, a single tube / fluid path (which may be made of glass and / or plastic or any fluid-compatible material), but is not limited thereto. The fluid path 712 may be fluidly connected to a partition and / or filling needle input 714. In some embodiments, the length of the tube may be any length and / or diameter that most efficiently and effectively induces degassing. While filling the reservoir / syringe 704 (which may include at least one plunger 708 in some embodiments), the fluid enters and passes through the heat exchanger which includes a fluid path 712 heated by the heating element 706, which can be heated to a predetermined temperature. Degassing may occur while it is being heated to the predetermined temperature.

[0153] Some embodiments of the filling adapter 700 include a heat source and / or a heating element 706. In various embodiments, the heating element 706 may include, but is not limited to, any heating element known in the art, including induction, optical, RF, microwave, electrical, or other.

[0154] In some embodiments, the fluid path 712 and / or the filling adapter 700 may be designed to heat the fluid at a desired and / or predetermined rate. Therefore, in some embodiments, additional features may be present on the filling adapter 700 to control the heating rate of the fluid and / or the flow rate of the fluid through the heating element 706. These may include, but are not limited to, pumps and / or active valves.

[0155] In some embodiments, the fluid may be heated to room temperature. In other embodiments, the fluid may be heated below room temperature, and in yet another embodiment, the fluid may be heated above room temperature. In some embodiments, the filling adapter 700 may include a processor (not shown) which may control the heating of the fluid according to one or more pre-programmed profiles. One or more profiles may be designed for various situations and / or various types of fluids. Depending on the desired temperature, the heat exchanger and / or filling adapter 700 may be designed accordingly.

[0156] Accordingly, in various embodiments, the use of embodiments of the filling adapter 700 may act to achieve at least one or more of the following: minimizing, reducing, and / or eliminating the downstream effects of degassing; minimizing, reducing, and / or eliminating the subjective amount of degassing so that the amount of degassing is controlled and / or predictable and can therefore be mitigated through other means; reducing, minimizing, eliminating, and / or reducing the occurrence of degassing; stabilizing the fluid temperature to minimize the potential effects of temperature rise between the refrigeration temperature and room temperature, for example; and reducing, eliminating, and / or minimizing, and / or reducing the effects of degassing in the reservoir 704, including but not limited to volume changes in the reservoir 704.

[0157] In some embodiments, there may be an air trap and / or a hydrophobic filter (not shown) or the like that allows air to escape from the heat exchanger. Thus, when the fluid is heated to a predetermined temperature, degassing occurs, and therefore minimizes degassing that may otherwise occur after filling the reservoir and / or syringe 704.

[0158] In some embodiments, a heating device (not shown) may be used to heat the reservoir 704 after it has been filled or partially filled (the term “filled” may be used to refer to the transfer of any volume of fluid into the syringe / reservoir, regardless of whether the fluid volume reaches its maximum or partial volume). The heating device may be a non-disposable / reusable device that includes an induction, optical, RF, microwave, electrical, or other heating element. The heating device may be configured to house the filled reservoir in contact with the heating element for heating. The heating element may be positioned such that heat is transferred to the reservoir and the heat is transferred to heat the fluid in the reservoir to a desired temperature. In some embodiments, the heating device may be designed to heat the fluid at a desired rate. Thus, in some embodiments, the heating device may have additional features that control the rate of heating of the fluid.

[0159] In some embodiments, the fluid may be heated to room temperature. In other embodiments, the fluid may be heated below room temperature, and in yet another embodiment, the fluid may be heated above room temperature. In some embodiments, the heating device may heat the fluid according to one or more pre-programmed profiles. One or more profiles may be designed for various situations and / or various types of fluids. Depending on the desired temperature, the heating device may be designed accordingly.

[0160] Therefore, in various embodiments, the use of the heating apparatus embodiment may, without limitation, act to achieve at least one or more of the following: minimizing, reducing, and / or eliminating the downstream effects of degassing; reducing, minimizing, and / or eliminating the subjective amount of degassing so that the amount of degassing is controlled and / or predictable and may therefore be mitigated through other means; reducing, minimizing, eliminating, and / or reducing the occurrence of degassing; stabilizing the fluid temperature, for example, to minimize the potential effects of temperature rise between the refrigeration temperature and room temperature; and reducing, eliminating, and / or minimizing, and / or reducing the effects of degassing in the reservoir, including but not limited to changes in the reservoir volume.

[0161] During heating, the fluid may outgasse. Therefore, after heating, the reservoir may be removed from the heating device, and before loading the reservoir 704 into the injection pump, air may be pushed out of the syringe / reservoir, for example, through the filling needle 710. Thus, the heating device can minimize and / or eliminate fluid delivery errors caused by heat.

[0162] In some embodiments, degassing of the fluid may be achieved by exposing the fluid to a partial vacuum before loading the fluid into the reservoir or before loading a reservoir filled with fluid into the injection pump. This may be achieved through several embodiments, including but not limited to one or more of the following:

[0163] In some embodiments, once the fluid has filled the reservoir, the filling needle may then be removed from the reservoir, and the reservoir may be capped with a cap that does not allow the fluid to move in and out of the reservoir. The plunger may be retracted to apply a vacuum to the fluid in the reservoir. Degassing may occur. The released air may then be pushed out of the reservoir before being loaded into the injection pump.

[0164] In some embodiments, after filling the reservoir, the reservoir may be placed inside the device or elsewhere where the reservoir is placed under partial vacuum. The fluid may be outgassed. The reservoir may then be loaded into the injection pump.

[0165] In some embodiments, in addition to degassing heating, the system may also combine a vacuum with a temperature rise / heating element, which may heat the fluid to a higher temperature. In some embodiments, the temperature rise may be minimized when applied with a vacuum. In addition, the applied vacuum may be minimized when applied with a temperature rise. Thus, in some embodiments, when the fluid is heated and a vacuum is applied to the fluid, the temperature rise and / or the level of vacuum applied may be minimized. Thus, in some embodiments, it may be desirable to apply the lowest possible vacuum to thereby reduce the amount and / or flow rate of turbulence through the heat exchanger and / or minimize the contact area across the heat exchange surface, and thus minimize and / or prevent extreme temperature and / or extreme pressure changes. This may be desirable for many reasons, including, but not limited to, maintaining the viability of the fluid.

[0166] In some embodiments, while under pressure, the fluid may be removed from the vial into a reservoir and / or syringe or other, and once the desired volume of fluid is loaded into the reservoir / syringe or other, the fluid path between the reservoir / syringe and the vial may be closed, and the syringe plunger may be kept retracted, i.e., a vacuum may be applied over the fluid. The syringe or other may then be vibrated and / or struck and / or a force may be applied at a predetermined point over a predetermined period, i.e., a pulse of force. This may promote / amplify bubble formation, i.e., degassing of the fluid, and therefore, in some embodiments, air / gas may be pushed out of the reservoir / syringe after the application of the vibrating force.

[0167] In some embodiments, an automated filling device may be used that connects a reservoir / syringe to a vial of fluid by a fluid line, which in some embodiments may be a filling needle. In some embodiments, the device may automate the filling of the reservoir / syringe. Subsequently, in some embodiments, the device may close / block the fluid line and apply vibration and / or force to the reservoir / syringe (i.e., draw vacuum into the reservoir / syringe). In some embodiments, this method may be performed more than once, for example, two or more times, and / or, in some embodiments, the device may determine whether a threshold volume of air has been removed from the fluid based on the volume of fluid in the reservoir / syringe and the amount of air extracted in a given trial, i.e., there may be a predetermined threshold target amount of air to be extracted. In some embodiments, for example, a syringe having a volume of 1.5 to 5 cc may be used and may be filled to half or a portion of its volume, after which vacuum is applied. In some embodiments, the device may include a camera and / or other sensors that determine the volume of fluid before and after air extraction / degassing in order to determine whether the threshold target has been met. In some embodiments, the device may communicate with a controller for the injection pump and / or the injection pump to input the amount of fluid in the reservoir before the reservoir is loaded into the injection pump. In some embodiments, this system may be beneficial for many reasons, including, but not limited to, improving air easing and increasing the accuracy of the volume of fluid to be filled into the syringe / reservoir. In some embodiments, the above systems and methods may include an optical sensor or other sensor to determine the displacement of the plunger.

[0168] In some embodiments, the automatic filling device may also measure the temperature of the fluid, which may be input to a control system 728 that determines the amount of working force acting on the filled reservoir / syringe, i.e., how much force is being applied to the syringe to extract air. For example, at colder temperatures, it may be more difficult to remove air, and therefore may require further or longer application of vacuum and / or further or longer application of vibration and / or force, or both. In some embodiments, the temperature of the fluid may also be input to the control system 728, which may also be input to the fluid heating. The amount may be determined using a temperature reading. In some embodiments, the temperature reading may be used to determine both the amount of force applied to the syringe and the amount of heating applied to the fluid.

[0169] In some embodiments, where it may be desirable to minimize the vacuum applied to the reservoir / syringe, for example to protect the fluid, the device may measure the force pulling the syringe (e.g., including a pressure sensor) to correlate the force with the pressure acting on the fluid, and thus determine when the vacuum is reduced to the point where it is no longer functioning. Thus, the force or pull on the reservoir / syringe may be an output to determine when to stop / cancele the force or pull, and also, based on the force, when it is likely that a sufficient amount of air has been drawn from the fluid.

[0170] In some embodiments, to determine the displacement of the plunger, the control system 728 may use an optical sensor, such as an optical displacement sensor, along with a pressure sensor that determines the pressure acting on the fluid, to calculate the volume of air removed and correlate the pressure with the displacement.

[0171] Referring here to Figure 18, one embodiment of a system for maintaining a lower positive pressure inside the fluid vial 702 is shown. It may be desirable to maintain the fluid that will ultimately be used in the reservoir at atmospheric pressure or near atmospheric pressure rather than a pressure that could introduce a larger volume of dissolved gas into the fluid. Therefore, in some embodiments, maintaining the fluid at atmospheric pressure or near atmospheric pressure can minimize degassing of the fluid after reservoir filling, as the amount / volume of dissolved gas in the fluid is limited compared to embodiments where the pressure inside the vial is higher or rising. As shown in Figure 18, in some embodiments, the needle 716 is inserted through the partition 718 of the vial 702. The needle 716 may include two ends, each open to the atmosphere. However, in some embodiments, the end exposed to the outside of the vial 702 may include a filter, which in some embodiments may be a hydrophobic filter (not shown), to maintain sterility and / or to keep the needle dry.

[0172] In some embodiments, the needle 716 may include a one-way check valve 720 at one end of the needle 716. In some embodiments, the one-way check valve 720 may have a cracking pressure of, for example, 1 or 2 PSI. When the pressure inside the vial 702 is sufficiently high, the vial 702 is evacuated. This can reduce the positive pressure inside the vial. In some embodiments, the check valve 720 may limit the pressure inside the vial 702 to, for example, the same as atmospheric pressure with an additional 1 or 2 PSI added. Thus, in these embodiments, the apparatus / system shown in Figure 18 may be beneficial for many reasons, including, but not limited to, limiting pressure resulting from atmospheric pressure changes.

[0173] Referring here to Figure 19, in some embodiments, the apparatus / system shown in Figure 18 may further include a vial manager device 722, which can be sized and molded to fit the vial 702 so that the vial manager device 722 can be detachably attached to the vial 702. In some embodiments, the vial manager device 722 may include a pump 724, which may be called an air pump, that is in fluid communication with the inside of the vial 702 via a needle 716. In some embodiments, a pump, which may be an electromechanical pump and / or a manually operated pump, may be used to pump air out of the vial 702. The pump 724 may be used to apply a low vacuum inside the vial 702. In some embodiments, the pump 724 may be a diaphragm pump, which may be battery-operated, and may, for example, work to draw a PSI below atmospheric pressure, and in various embodiments, may include drawing a vacuum inside the vial 702 at PSIs from less than 1 to 12. In some embodiments, the vial manager device 722 may include a power source, i.e., a battery 726, that provides power to at least the pump and / or processor. In some embodiments, the vial manager device 722 may also include a processor 726 and / or a timer that can be pre-programmed to turn the pump 724 on and off to limit the vacuum, for example, the pump 724 may pump for 30 seconds every 5 minutes. However, in some embodiments, the duration and / or frequency of the pump being on may depend on the leakage rate of the vial 702. In some embodiments, the pump 724 may be operating at all times.

[0174] In some embodiments, the vial manager device 722 may also include a pressure sensor (not shown) located in the path of the needle 716. In various embodiments, the pressure sensor may communicate with a processor / control system 728, and the pump 724 may be activated based on pressure data from the pressure sensor. In some embodiments, if the pressure sensor is included in the needle 716, the device may use the pressure sensor reading to determine whether the vial 702 is tilted. In some embodiments, if tilting is determined, the vial manager device 722 may alarm using any type of alarm, including but not limited to flashing or one or more lights, an audible alarm and / or a vibration alarm. Determining when the vial 702 is tilted can be beneficial for many reasons, including but not limited to the pump 724 being unable to deliver air because once the vial 702 is tilted, the fluid may come into contact with the needle 716. Thus, the vial manager device 722 may be unable to draw a vacuum to the vial 702. Therefore, it may be desirable to alarm / warn once the vial 702 is tilted. In some embodiments, this alarm warning may be triggered by a pressure sensor.

[0175] In some embodiments, the vial manager device 722 may include one or more lights to indicate the status, for example, one or more green lights and one or more red lights to indicate the status of the vial manager device 722 and / or the vial 702. In some embodiments, the vial manager device 722 may include one light that can indicate various status conditions, for example, by flashing.

[0176] In some embodiments, the vial manager device 722 may include at least one accelerometer, which may be connected to the processor 728. This may be used to determine when / if the vial is tilted during storage. In some embodiments, the vial manager device 722 may also include at least one alarm (e.g., vibration and / or acoustic and / or visual) to warn the user / caregiver that the device has tilted. In some embodiments, the needle 716 may include a filter, which in some embodiments may be a hydrophobic filter (not shown). The hydrophobic filter may be beneficial for many reasons, including, but not limited to, protecting the air pump 724 from the discharge fluid.

[0177] In some embodiments, the processor 728 of the vial manager device 722 may include a vial manager control system. The system may include at least one temperature sensor which may be located inside the vial manager device 722 and which may communicate with the processor 728. The at least one temperature sensor may provide temperature data at a predetermined frequency, for example, every 5 minutes, and the device 702 may alarm / warn at high or low temperature readings above a threshold. In some embodiments, the vial manager device 722 may include a timekeeper, for example, a timer which can be started when the vial manager device 722 is connected to a vial 702, and after a predetermined time, for example, 28 days, the vial manager device 722 may alarm / warn the user that the vial should be replaced and / or has been used for a predetermined amount of time. This may be beneficial for many reasons, including, but not limited to, warning the user when the fluid inside the vial 702 may have expired, thereby ensuring that the user does not use expired fluid and / or medication for treatment.

[0178] The vial manager device 722 may be made of any material, including but not limited to any kind of plastic and / or metal, in some embodiments. In some embodiments, the vial manager device 722 is positioned to cover the top of the vial 702, and a timer may start counting down once the needle 716 punctures the partition 718. Thus, the vial manager device 722 provides a system to ensure that the pressure inside the vial 702 is maintained and that a method is provided for determining when the vial 702 was first used, i.e., when the needle 716 was first inserted into the vial 702. In some embodiments, the vial manager device 722 may be used while the vial 702 is "in use," for example, while a user is using the vial 702 for treatment.

[0179] In some embodiments, the vial manager device 722 may include disposable and reusable parts. For example, in some embodiments, the part of the vial manager device 722 that connects to the vial 702, including the needle 716, may be included in the disposable part. Thus, the reusable part may include, but is not limited to, a processor, power supply, and pump. This may be beneficial for many reasons, including, but not limited to, the reusability of many elements of the vial manager device 722.

[0180] In some embodiments, a patch-type pressure and / or force gauge may be placed on a fluid vial, and in some embodiments, on an insulin vial. The pressure gauge may inform the user of the current pressure in the vial. In some embodiments, the pressure may be indicated as a range of shades. Any patch-type pressure gauge, including an irreversible pressure label, may be used. In some embodiments, a reversible pressure label may be used, or a label with both reversible and irreversible components may be used.

[0181] In some embodiments, pressure and / or force labels may be included on the vial. These labels may indicate an increased volume of air saturation in the fluid, i.e., which may lead to additional degassing of air; they may indicate an increase in the volume of dissolved air in the fluid; and they may also indicate whether pressure / force has been applied to the vial, including, but not limited to, determining whether pressure / force has been applied. In some embodiments, this may also indicate that the fluid vial may be damaged, and therefore it may be desirable for the user / caregiver to know whether the vial is damaged.

[0182] For example, U.S. Patent No. 7,498,563 (Agent No. D78), issued on March 3, 2009, titled Optical Displacement Sensor for Infusion Devices; U.S. Patent No. 7,306,578 (Agent No. C54), issued on December 11, 2007, titled Loading Mechanism for Infusion Pump; International Application PCT / US2009 / 060158, filed on October 9, 2009, titled Infusion Pump Assembly; International Publication No. 2010 / 042814 (Agent No. F51WO), published on April 15, 2010; and Application filed on February 9, 2007, titled Fluid Delivery Systems and U.S. Patent Application No. 11 / 704,899, titled Methods, now published as U.S. Patent Application Publication No. US-2007-0228071-A1 (Agent Reference Number E70) on October 4, 2007; U.S. Patent Application No. 12 / 347,985, titled Infusion Pump Assembly, filed on December 31, 2008, now published as U.S. Patent Application Publication No. US-2009-0299277-A1 (Agent Reference Number G75) on December 3, 2009; and Systems and Methods for In various injection devices, including those shown and described in U.S. Patent Application No. 12 / 560,106, entitled Fluid Delivery, now published U.S. Patent Application Publication No. US-2010-0185142-A1 (Agent Reference Number G47) on 22 July 2010, in some embodiments, the disposable / reservoir portion of the injection pump may include one or more coatings to reduce bubbles. The coatings may be applied to the fluid pathways within the disposable / reservoir portion and / or to the outside of the reservoir. With respect to coatings applied to the fluid pathways, in some embodiments, the coatings may be applied in such a way that they alter the surface tension properties so that the surface becomes more hydrophilic. Increasing the hydrophilicity of the fluid pathways may alter the contact angle between bubbles and the fluid pathway surface, thus enabling bubble reduction by priming and pumping. In some embodiments, the coatings may be applied to rigid plastic portions and / or membrane portions.

[0183] With respect to the reservoir, in some embodiments, the coating may be applied to the outside of the reservoir. The coating may be selected to reduce the permeability of the reservoir, and therefore may reduce the rate at which air penetrates the reservoir, and therefore may minimize and / or reduce the rate at which bubbles form in the reservoir. Since the coating may be applied to the outside of the reservoir, the coating that can be used may be any desired material and is not limited to fluid-compatible materials. In some embodiments, the coating may include, but is not limited to, parylene and / or oil. In some embodiments, the reservoir may be coated on the outside, and the coating may prevent inward air diffusion and outward water vapor diffusion. In some embodiments, the inside of the reservoir may be coated with parylene and / or oil, and / or hydrophilic coating materials from SurModics, Inc. (Eden Prairie, Minnesota, USA), or hydrophilic coatings that may be compatible with the fluid in the reservoir, but is not limited to these materials. In some embodiments, this may be desirable to allow air to move through the reservoir material.

[0184] (altimeter) Referring here to various embodiments of an infusion pump, including those described in U.S. Patent No. 7,498,563 (D78), issued on March 3, 2009, entitled Optical Displacement Sensor for Infusion Devices; U.S. Patent No. 7,306,578 (C54), issued on December 11, 2007, entitled Loading Mechanism for Infusion Pump; and International Application PCT / US2009 / 060158, filed on October 9, 2009, entitled Infusion Pump Assembly, now International Publication WO2010 / 042814 (F51 WO), published on April 15, 2010, and other infusion pumps known in the art, in some embodiments an altimeter may be introduced into the infusion pump.

[0185] Referring to both, by reference, the entirety of these is incorporated herein by reference: U.S. Patent Application No. 11 / 704,899, filed on 9 February 2007, titled Fluid Delivery Systems and Methods, now published U.S. Patent Application Publication No. US-2007-0228071-A1 (Agent Reference Number E70), published on 4 October 2007; and U.S. Patent Application No. 12 / 347,985, filed on 31 December 2008, titled Infusion Pump Assembly, now published U.S. Patent Application Publication No. US-2009-0299277-A1 (Agent Reference Number G75), in some embodiments, an altimeter may be used in acoustic capacitance measurement to vary the suppression based on ambient pressure, for example. Referring still to U.S. Patent Application No. 11 / 704,899, filed on February 9, 2007, titled Fluid Delivery Systems and Methods, now published U.S. Patent Application Publication No. US-2007-0228071-A1 (Agent Reference Number E70), published on October 4, 2007, and U.S. Patent Application No. 12 / 347,985, filed on December 31, 2008, titled Infusion Pump Assembly, now published U.S. Patent Application Publication No. US-2009-0299277-A1 (Agent Reference Number G75), in some embodiments, the disposable / reservoir portion of the infusion pump may include an intravenous needle connected to tubing rather than an infusion set, as discussed in various embodiments. Therefore, in some embodiments, the infusion pump may be used for intravenous administration and is not limited to subcutaneous injection. In some of these embodiments, the fluid injected may be one used to minimize bleeding, such as morphine and / or antihypertensive drugs and / or other therapeutic agents.

[0186] (Cannula detection) In some embodiments of the infusion pump, the cannula may be inserted into the user so that it can be positioned directly between the user's skin and the infusion pump. This presents several challenges, not limited to those, including determining when the cannula has been removed and determining occlusion within the cannula.

[0187] In some embodiments, two electrode contacts may be used. One electrode contact may be located between the infusion pump and the user's skin and be in contact with the user's skin, while the other is in electrical contact with the infusion pump. An electrical path is established between the two electrodes. Using high impedance / low voltage, the impedance between the two electrodes is determined and tracked. If the impedance reaches a very high value, e.g., "infinite," occlusion and / or cannula detachment may be inferred. The user may be warned. This may be preferable because, if the cannula has been detached, the user is no longer receiving fluid therapy. In the case of an insulin pump, the user may experience a hyperglycemic event. Early detection and user warning may increase the safety of these types of infusion pumps.

[0188] While the principles of the present invention have been described herein, it will be understood by those skilled in the art that this description is provided only as an example and not as a limitation on the scope of the invention. In addition to the exemplary embodiments shown and described herein, other embodiments are conceivable within the scope of the invention. Modifications and substitutions by those skilled in the art will be considered within the scope of the invention.

Claims

[Claim 1] Inventions relating to medical devices.

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