Injection pump system including temperature compensation for injection rate adjustment

Abstract

Providing an injection pump system that includes temperature compensation for adjusting the injection rate. [Solution] An injection pump system is disclosed. The system includes a syringe having a plunger in a syringe barrel, the syringe having at least one temperature determining device adjacent to the syringe as an outlet end, at least one device for determining the distance the plunger has moved relative to the syringe barrel, and a pump processor communicating with the at least one temperature determining device and at least one optical sensor, wherein when the controller determines a temperature change and the corresponding plunger movement, the controller increases or decreases a pre-programmed injection pump base rate by a predetermined amount for a predetermined time.

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 / 297,387, filed on January 22, 2010, entitled "Infusion Pump Apparatus, Method and System", Attorney Docket No. H83, which is hereby incorporated by reference in its entirety.

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

Background Art

[0003] (Background Information) 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, making it difficult for patients to maintain the desired schedule. In such cases, parenteral delivery is often or can be employed.

[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 self - injected by millions of diabetic patients. Users of parenterally delivered drugs can potentially benefit from wearable devices that will 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 are 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, presenting the challenge of frequent repositioning for application. [Overview of the Initiative] [Means for solving the problem]

[0006] According to one aspect of the present invention, an injection pump system is disclosed. The system includes a syringe having a plunger in a syringe barrel, the syringe having an outlet end, and a pump processor communicating with at least one temperature determining device adjacent to the syringe, at least one device for determining the distance the plunger has moved relative to the syringe barrel, and at least one optical sensor, wherein when the controller determines a temperature change and the corresponding plunger movement, the controller increases or decreases a pre-programmed basal rate of the injection pump by a predetermined amount for a predetermined time.

[0007] Some embodiments may include one or more of the following: When the pump processor determines an upward temperature change and a corresponding plunger movement away from the syringe outlet, the pump processor increases the pre-programmed base rate of the injection pump by a predetermined amount for a predetermined time. When the pump processor determines a downward temperature change and a corresponding plunger movement toward the syringe outlet, the pump processor decreases the pre-programmed base rate of the injection pump by a predetermined amount for a predetermined time. At least one temperature determining device is a thermistor. At least one device for determining the distance the plunger has traveled relative to the syringe barrel is an optical sensor.

[0008] According to one aspect of the present invention, an injection pump system is disclosed. The injection pump system includes a syringe having an outlet end and a plunger movable within the syringe, at least one temperature determining device, at least one device for determining the effect of temperature changes on the movement of the plunger, and a pump processor for compensating for the movement of the plunger based on the temperature changes.

[0009] Some embodiments may include one or more of the following: The pump processor instructs the plunger to move a predetermined distance away from the syringe outlet and to compensate for the plunger's movement based on the temperature change. The pump processor reduces a pre-programmed base rate by a predetermined amount for a predetermined time based on the plunger's movement due to the temperature change. At least one temperature-determining device is located adjacent to the syringe. At least one temperature-determining device is a thermistor. At least one device for determining the effect of the temperature change on the plunger's movement is an optical sensor.

[0010] According to one aspect of the present invention, an injection pump system is disclosed. The injection pump system includes a syringe having an outlet end and a plunger movable within the syringe, at least one temperature determining device, at least one device for determining the effect of temperature changes on the movement of the plunger, and a pump processor communicating with the at least one temperature determining device and the at least one device for determining the effect of temperature changes on the movement of the plunger.

[0011] Some embodiments may include one or more of the following: At least one device for determining the effect of temperature changes on the movement of the plunger is a flow sensor located downstream of the syringe outlet. At least one device for determining the effect of temperature changes on the movement of the plunger is a occlusion device located downstream of the syringe outlet, the occlusion device occludes a flow path, and the occlusion device is controlled by a pump processor. At least one device for determining the effect of temperature changes on the movement of the plunger is at least one binary valve located downstream of the syringe outlet, the at least one binary valve occludes a flow path, and the at least one binary valve is controlled by a pump processor. At least one device for determining the effect of temperature changes on the movement of the plunger is a strain beam located in a force relationship with the plunger. At least one device for determining the effect of temperature changes on the movement of the plunger is at least one potentiometer. The plunger further comprises a predetermined volume of material that undergoes a phase change during a temperature change event. The material is wax, which undergoes a phase change, causing the plunger to move forward by a predetermined distance. The resulting change compensates for the volume change of the syringe due to temperature changes.

[0012] According to one aspect of the present invention, an injection pump system is disclosed. The injection pump system includes a syringe having an outlet end and a plunger movable within the syringe; an occluder located downstream from the syringe outlet; at least one temperature determining device; and a pump processor communicating with the occluder and the at least one temperature determining device, the pump processor activating the occluder based on a temperature signal from the at least one temperature determining device.

[0013] Some embodiments may include one or more of the following: When at least one temperature determination device signal indicates a temperature change exceeding a predetermined threshold, the pump controller activates a blocker. The pump controller activates the blocker during pump delivery.

[0014] According to one aspect of the present invention, a method for delivering fluid by an injection pump is disclosed. The method includes the steps of determining the distance a plunger should travel to deliver a target volume, determining the volume of fluid to be delivered when the temperature changes, determining the position of a target plunger, and adjusting the position of the target plunger based on the actual movement of the temperature change.

[0015] According to one aspect of the present invention, a method for delivering fluid by an injection pump is disclosed. The method includes the steps of determining a temperature change, determining that the rate of change has exceeded a threshold, and adjusting the base rate.

[0016] According to one aspect of the present invention, a system, method, and apparatus for temperature compensation in an injection pump, and an injection pump having temperature compensation are disclosed. The system includes at least one temperature sensor, which communicates with at least one processor. The processor may determine a target plunger position based on communication from at least the temperature sensor and modify the target plunger position based on the sensed temperature.

[0017] Some embodiments may include one or more of the following: a blockage and / or binary outlet valve, at least one optical sensor, and at least one flow sensor.

[0018] According to one aspect of the present invention, a system for temperature compensation in an injection pump is disclosed. The system includes characterization of the injection pump at various temperatures, including characterization of the volume of fluid being pumped, based on a request or temperature change. It also includes at least one temperature sensor, which collects data indicating the temperature inside or outside the injection pump and communicates the data to a processor. The processor compares the data with the characterization and may decide to adjust the target plunger position based on the temperature. Some embodiments may include a blocker and / or a binary outlet valve.

[0019] According to one aspect of the present invention, a device for insulating an injection pump is disclosed. The device includes a housing of a predetermined size for housing the injection pump, the housing having at least one insulating layer. The housing includes an opening of a predetermined size for housing pipes.

[0020] Some embodiments may include one or more of the following: a strap, an adjustable strap, a strap including a buckle, or an insulating layer made of a material that provides a cooling effect on the housing when the device is wet, refrigerated, or frozen.

[0021] According to one aspect of the present invention, an injection pump having a heater includes a heating device and at least one temperature sensor such that the temperature is communicated to a processor that controls the heating device and activates the heating device for a sufficient time to maintain the temperature of the injection pump at a predetermined temperature.

[0022] According to one aspect of the present invention, a temperature label for a fluid vial is disclosed. The temperature label visually indicates the temperature of the vial. Some embodiments of this aspect of the present invention may include the temperature label being irreversible.

[0023] 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) An injection pump system, wherein the injection pump system is A syringe having a plunger that can move within the syringe barrel, the syringe having an outlet end, At least one temperature-determining device adjacent to the syringe, A device for determining the distance the plunger has traveled relative to the syringe barrel, A pump processor that communicates with the at least one temperature determination device and the at least one optical sensor A system comprising a controller that, when determining a temperature change and a corresponding plunger movement, increases or decreases the pre-programmed basal rate of the infusion pump by a predetermined amount for a predetermined time. (Item 2) The system according to item 1, further comprising that when the pump processor determines an increase in temperature and a corresponding plunger movement away from the syringe outlet, the pump processor increases the pre-programmed basal rate of the infusion pump by a predetermined amount for a predetermined time. (Item 3) The system according to item 1, further comprising that when the pump processor determines a decrease in temperature and a corresponding plunger movement towards the syringe outlet, the pump processor decreases the pre-programmed basal rate of the infusion pump by a predetermined amount for a predetermined time. (Item 4) The system according to item 1, further comprising that the at least one temperature determination device is a thermistor. (Item 5) The system according to item 1, further comprising that the at least one device for determining the distance the plunger has moved relative to the syringe barrel is an optical sensor. (Item 6) An infusion pump system, the infusion pump system comprising A syringe having an outlet end and a plunger movable within the syringe, At least one temperature determination device, At least one device for determining the effect of a temperature change on the movement of the plunger, A pump processor for compensating the movement of the plunger based on the temperature change And a system. (Item 7) The system according to item 6, wherein the pump processor compensates for the movement of the plunger due to temperature changes by commanding the plunger to move a predetermined distance away from the syringe outlet. (Item 8) The pump processor, according to item 6, reduces a pre-programmed base rate by a predetermined amount for a predetermined period of time based on the movement of the plunger due to a temperature change. (Item 9) The system according to item 6, wherein the at least one temperature determining device is located adjacent to the syringe. (Item 10) The system according to item 6, wherein the at least one temperature determining device is a thermistor. (Item 11) The system according to item 6, wherein at least one device for determining the effect of the temperature change on the movement of the plunger is an optical sensor. (Item 12) An injection pump system, wherein the injection pump system is A syringe having an outlet end and a plunger that is movable inside the syringe, At least one temperature determination device, A device for determining the effect of temperature changes on the movement of the plunger, A pump processor that communicates with the at least one temperature-determining device and the at least one device for determining the effect of temperature changes on the movement of the plunger. A system that includes this. (Item 13) The system according to item 1, wherein at least one device for detecting the effect of temperature changes on the movement of the plunger is a flow sensor located downstream from the syringe outlet. (Item 14) The system according to item 1, wherein at least one device for detecting the effect of temperature changes on the movement of the plunger is an occlusion device located downstream from the syringe outlet, the occlusion device occludes the flow path, and the occlusion device is controlled by the pump processor. (Item 15) The system according to item 1, wherein the at least one device for detecting the effect of temperature changes on the movement of the plunger is at least one binary valve located downstream from the syringe outlet, the at least one binary valve occludes a flow path, and the at least one binary valve is controlled by the pump processor. (Item 16) The system according to item 1, wherein the at least one device for determining the effect of temperature changes on the movement of the plunger is a strain beam located in a force relationship with the plunger. (Item 17) The system according to item 1, wherein at least one device for determining the effect of temperature changes on the movement of the plunger is at least one potentiometer. (Item 18) The system according to item 1, wherein the plunger further comprises a predetermined volume of material that undergoes a phase change during a temperature change event. (Item 19) The system according to item 18, wherein the material is wax, and the wax undergoes a phase change, causing the plunger to move forward by a predetermined distance, and thereby the resulting change compensates for a volume change of the syringe caused by a temperature change. (Item 20) An injection pump system, wherein the injection pump system is A syringe having an outlet end and a plunger that is movable inside the syringe, A occluding device located downstream from the syringe outlet, At least one temperature determination device, A pump processor that communicates with the blocker and the at least one temperature determining device, wherein the pump processor activates the blocker based on a temperature signal from the at least one temperature determining device. A system that includes this. (Item 21) The system according to item 20, wherein the pump controller activates the blocker when the signal from at least one temperature determination device indicates a temperature change exceeding a predetermined threshold. (Item 22) The pump controller activates the blocker during pump delivery, as described in item 20. (Item 23) A method for delivering fluid by an injection pump, the method is Determining the distance the plunger should travel to deliver the target volume, Determining the volume of fluid delivered when the temperature changes, Determining the target plunger position, Adjust the target plunger position based on the actual movement due to temperature changes. Methods that include... (Item 24) A method for delivering fluid by an injection pump, the method is Determining temperature changes, Determining that the rate of change exceeds a threshold, Adjusting the base rate and Methods that include... (Item 25) A system for temperature compensation of an injection pump, the system is At least one temperature sensor, At least one processor, which communicates with the temperature sensor and A system comprising a processor that determines the position of a target plunger and corrects the position of the target plunger based on the temperature sensed, at least based on communications from the temperature sensor.

[0024] These and other features and advantages of the present invention will be better understood by reading the following detailed description in conjunction with the following drawings. [Brief explanation of the drawing]

[0025] [Figure 1-1] Figures 1A and 1B are isometric front and rear views of an embodiment of an 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 face-hook fastener configurations according to several embodiments. [Figure 11] Figure 11 shows an example of one embodiment of the holder. [Figure 12] Figure 12 shows an example of one embodiment of a user attaching the holder. [Figure 13] Figure 13 shows an example of one embodiment of the back of the holder. [Figure 14] Figure 14 shows an example of one embodiment of a vial having a thermometer / label. [Modes for carrying out the invention]

[0026] (definition) As used in this description and the attached claims, the following terms shall have their meanings unless the context requires otherwise.

[0027] "Device" means a medical device, including but not limited to infusion pumps and / or controllers, i.e., devices 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."

[0028] "Companion" means a device for wireless control of another medical device. In exemplary embodiments, the companion may also include a glucose meter / piece reader.

[0029] The device's "inputs" may include any mechanism by which the device's user or other operator / caregiver can control the device's functions. User inputs may include mechanical arrangements (e.g., switches, push buttons, jog wheels (one or more)), 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.

[0030] In the context of inputs such as those referred to below as "bolus buttons," the term "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.

[0031] "Alarm" includes any mechanism by which a warning can be generated to a 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 overlapping mechanisms (e.g., two different acoustic alarms) or complementary mechanisms (e.g., an acoustic alarm, a tactile alarm, and a wireless alarm).

[0032] "Fluid" refers to a substance that can flow through streamlines, such as a liquid.

[0033] "User" includes any person or animal receiving fluid from a fluid delivery device, whether as part of drug therapy or not, or any caregiver or third party involved in programming the device to inject fluid into another, or otherwise interacting with the device.

[0034] "Cannula" means a disposable device that can inject fluid into a user. As used herein, cannula may refer to a typical cannula or needle.

[0035] "Disposable" refers to a part, device, component, or other item intended for use for a fixed period and then discarded or replaced.

[0036] "Reusable" refers to a portion intended to have an unlimited period of use.

[0037] "Acoustic volume measurement" means the quantitative measurement of the relevant volume using acoustic techniques, such as those described in U.S. Patents 5,349,852 and 5,641,892 (which are incorporated herein by reference in their entirety), and other techniques.

[0038] A "temperature sensor" includes any temperature determination device / mechanism for measuring temperature and communicating temperature information to the controller and / or pump processor. The devices described herein may include, but are not limited to, one or more temperature sensors for measuring user skin temperature, AVS temperature, ambient temperature, internal pump temperature, plunger temperature, drive system temperature, and fluid temperature.

[0039] 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 previously stated. 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 specific embodiments described 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,” or “fluid” are used interchangeably, however, any fluid may be used in other embodiments, as previously stated. Thus, the devices and descriptions contained herein are not limited to therapeutic use.

[0040] 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 help deliver insulin, assisting or supplementing the action of pancreatic islet cells in a person living with diabetes (referred to as the user). Embodiments adapted for insulin delivery seek 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. Furthermore, basal levels and / or bolus levels may be triggered or adjusted in response to the output of a glucose meter, and in exemplary embodiments, integrated into a controller. In other embodiments, the controller further includes a glucose monitoring device that receives data from a blood glucose sensor. In some embodiments, the bolus may be triggered by the user using a designated button or other input means located on the device, i.e., on the controller and / or the infusion pump. In yet another embodiment, the bolus or base may be programmed or administered through a user interface located either on the fluid delivery device / injection pump and / or on the controller.

[0041] With regard to the names given to screens, the types of screens, and appropriate names given to various features, these terms may vary across different embodiments.

[0042] 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 located on the infusion pump and / or on the controller. Furthermore, where the description relates to an infusion pump “screen”, this “screen” may also appear on the controller, or, instead of the pump, appear on the controller.

[0043] The infusion pumps considered in this description include pumps capable of pumping any fluid, including but not limited to therapeutic fluids, including but not limited to insulin. Therefore, where this description describes exemplary embodiments in relation to insulin, this is for illustrative purposes only, and the devices are not intended to be limited to insulin. Other fluids are also considered. In some embodiments, the methods, systems, and devices described herein may be used in conjunction with insulin “pens” and / or fluid delivery “pens” that are well known in the art.

[0044] The infusion pump may be any infusion pump, for example, the pump devices illustrated and described in relation to Figure 1A-1F, which are incorporated herein by reference, but are not limited to these. In various exemplary embodiments, the infusion pump is a syringe-pump, i.e., a fluid is pumped or delivered to the user when a plunger advances through the syringe and pushes the fluid inside the syringe into a cannula. 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.

[0045] 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, however, 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, which may be similar to, or larger or smaller than, those shown in Figures 1A, 1D, and 1F, is included on the controller or companion device. An embodiment of the controller or companion device is shown in Figure 3.

[0046] Referring to Figure 1A-1F, an embodiment of an injection pump assembly 100 that may be housed within an encasing assembly 102 is 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 arranged 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 can be removably connected. A removable cover assembly 116 may allow access to the power cavity 118 (shown as a phantom in Figure 1D).

[0047] Referring to the injection pump assembly shown in Figures 1A to 1F, the injection pump assembly 100 may include processing logic (not shown), such as a pump processor, which performs one or more processes that may be required for the injection pump assembly 100 to function 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.

[0048] 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 referred to as a device for determining and / or detecting the distance a plunger has traveled 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 from and insertable into the 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).

[0049] 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, filed October 9, 2009, titled International Application PCT / US2009 / 060158, and published April 15, 2010, now titled U.S. Patent Application Publication US-2010-0094222, titled Infusion Pump Assembly, filed October 10, 2008, titled Infusion Pump The reservoir assembly may be as described in U.S. Patent Application No. 12 / 249,882, 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 part, for example, the reservoir assembly may include, but is not limited to, a barrel having a plunger, a cassette, or a container constructed of at least partially flexible membrane.

[0050] 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 lead screw assembly 428, which may be rotatable by a motor assembly 416 in response to a signal received from 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 lead screw assembly 428 may form a pump assembly that results in the dispensing of the injectable fluid 422 contained in the reservoir assembly 430. Embodiments of the partial nut assembly 426 may include, but are not limited to, a nut assembly configured to wrap around the lead screw assembly 426 only by 30 degrees. In some embodiments, the pump assemblies may be similar to those described in U.S. Patent Application No. 7,306,578, issued on December 11, 2007, titled Loading Mechanism for Infusion Pump, published on April 15, 2010, now titled Infusion Pump Assembly, U.S. Patent Application No. 12 / 249,882, filed on October 10, 2008, titled Infusion Pump Assembly, published on April 16, 2009, now titled Infusion Pump Assembly, U.S. Patent Application No. 12 / 249,891, filed on October 10, 2008, titled Infusion Pump Assembly, all of which are incorporated herein by reference in their entirety.

[0051] (User interface) Throughout this description, a screen may be referred to in relation to a “pump,” a “companion,” or a “controller.” However, in various embodiments, a similar screen or method may be achieved on a different device. For example, if a screen or method is referred to in relation to a “pump,” a similarly functional screen or method may be used on a “companion” or “controller” in other embodiments. Since this description includes embodiments relating to both pumps with and without displays, it should be obvious that if an embodiment includes an injection pump without a display, any screen would be visible on the companion or controller. Similarly, if a method requires interaction between a user and a pump, and the pump is an injection pump without a display, the interaction may be achieved via a switch assembly on the pump.

[0052] In some embodiments, as illustrated and described with respect to Figure 4, processing logic is used to receive input from a user or caregiver, including at least one element. The user or caregiver uses one or more input devices or assemblies, including but not limited to button / switch assemblies, capacitive sliders (for example, U.S. Patent Application No. 11 / 999,268, filed on December 4, 2007, titled Medical Device Including a Slider Assembly, published on July 24, 2008, now titled Medical Device Including a Slider Assembly, and all of these are incorporated herein in their entirety by reference), jog wheels, and / or touch screens. The infusion device also receives inputs 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, 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 interaction experience includes, but is not limited to, reading / viewing text and / or figures on a display, interaction with a display (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 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 and controls the infusion pump.

[0053] 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 referred to as 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 other figures, in particular Figures 1A to 1F) 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 the remote control assembly 300 may include telemetry circuitry (not shown) that enables remote control of the injection pump assembly 100. The remote control assembly 300 (which may also include a telemetry circuit (not shown) and may be able to communicate 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 input to the device) and one or more of the switch assemblies 304, 308. Thus, the remote control assembly 300 includes a jog wheel 306 and a slider assembly 310 as shown in Figure 3, although some embodiments may include only one of the jog wheel 306 or the slider assembly 310, or another conventional mode for input to the device. In embodiments having a jog wheel 306, the jog wheel 306 may include a wheel, ring, knob, etc., which may be coupled, at least in part, to a rotary encoder or other rotary transducer to provide a control signal based on the movement of the wheel, ring, knob, etc.

[0054] The remote control assembly 300 may include the ability to pre-program base rates, bolus alarms, and delivery limits, and may also allow the user to view history and establish user preferences. The remote control assembly 300 may also include a glucose strip reader 312.

[0055] 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 enhance the security level.

[0056] 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 impact of various interactions on 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 an 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 any pending changes, closes the confirmation screen, and returns to the previous screen (i.e., the screen before the screen from which the user pressed the back button). If the action selection on the "Do you want to cancel the changes?" 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 pending changes. This feature prevents a situation where users mistakenly believe changes have been implemented when in reality they haven't. Therefore, it ensures that users understand that changes have not been implemented.

[0057] (temperature) In various embodiments of the infusion pump, the user may wear the infusion pump attached to a belt, another article or garment, i.e., clothing on which the device is worn, 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, if 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. 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 warm room, and / or being under a blanket or other warming material.

[0058] As mentioned 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 can generally be called the coefficient of volumetric thermal expansion. Therefore, during temperature fluctuations / differentiations / changes, whether positive or negative, the fluid, i.e., insulin, will expand or contract. Various factors, including but not limited to the rate of temperature change, can 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.

[0059] Furthermore, in various embodiments of the devices described, the components of the pump also have a coefficient of thermal expansion. These coefficients of thermal expansion can vary depending on the material. Therefore, if the various components are made of different materials, the coefficients of thermal expansion can vary.

[0060] 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 temperature increase may result in an increase in the diameter of the reservoir / syringe 430 (see Figure 4, for illustrative purposes only). This may be because the relative thermal expansion of the syringe compared to the fluid will influence whether the fluid is delivered or pulled. This, in turn, may cause any fluid / insulin in the cannula 450 to flow back into the reservoir 430. In this case, the volume of fluid / insulin is pulled back into the reservoir. Thus, a subsequent delivery request by the processing logic 400 may result in only this evacuated volume being delivered to the user. Thus, the volume of fluid / insulin (evacuated volume) is not delivered to the user without a request or grasp by the user. Another embodiment involves a temperature decrease. In some embodiments, a temperature decrease may result in a decrease in 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.

[0061] Therefore, in the first embodiment, the user may receive less fluid / insulin than necessary or requested, and thus experience hyperglycemia. In the second embodiment, the user may receive more fluid / insulin than necessary or requested, and thus experience hypoglycemia. In either embodiment, the user receives a volume of fluid / insulin that is not identical to the requested or programmed therapy, and is not informed of this difference.

[0062] 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 accommodate additional assumptions, e.g., shapes other than cylindrical, or syringes with movable plungers.

[0063]

number

[0064]

number

[0065] Therefore, the linear coefficient of expansion is linear.

[0066] [ka] For polypropylene, a material having [specific properties], when the temperature changes from 30°C to 10°C, the volume change of a cylindrical object made of polypropylene is:

[0067]

number

[0068] The specific 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 would be approximately 3.6 μL. However, the syringe plunger may also move in response to thermal expansion, depending on the plunger material and the relationship of the syringe within the pump (e.g., the design of the syringe holder in the pump).

[0069] Therefore, it may be desirable to minimize the effect of temperature on fluid delivery. Accordingly, it may be desirable to limit or minimize and / or characterize the thermal expansion of one or more components of the fluid and / or injection pump. The described systems, methods, and apparatus 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.

[0070] In some embodiments, selecting a material with a predictable and favorable coefficient of thermal expansion can minimize the possibility of under- or over-expansion of the fluid, as described 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

[0071]

number

[0072] Therefore, the syringe material may be selected to have a coefficient of thermal expansion close to this value. For example, a mixture of polycarbonate and acrylonitrile butadiene styrene (also known as "ABS") may 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 an expansion coefficient close to the exact one such that the volume delivered by the syringe pump, due to the measured temperature change, is minimal and / or acceptable. In some embodiments, the selected plastic or material may be tuned to the gradient of the thermal expansion of the fluid.

[0073] 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. 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.

[0074] In some embodiments, the material for any one or more injection pump components may have an inverse thermal coefficient or be a thermally compensating material, and may be selected to minimize the effect of thermal expansion with temperature. For example, at temperatures higher than the temperature at 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 inverse thermal coefficient. Thus, the syringe does not undergo volume change with increasing temperature.

[0075] In some embodiments, the use of a material that undergoes 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, the wax features may be added to move the plunger forward by a (predetermined) distance such that the resulting change in volume is equal to the square root of the plunger's diameter. Thus, in some embodiments, the use of a material that undergoes phase change in response to temperature / temperature change / differential may be used to compensate for changes in the syringe volume due to temperature changes. In some embodiments, a material that undergoes phase change in response to temperature changes can absorb thermal differential energy, and therefore, for example, if the temperature is rising rather than the temperature of the injection pump, the wax or other phase-changing material may melt the wax / phase-changing material and thus act as an energy absorber, absorbing heat.

[0076] In some embodiments, the syringe may be constrained so that temperature changes can cause the plunger to advance or withdraw, compensating for changes in the syringe's volume. For example, in some embodiments, the syringe may be held in a metal case, and the metals that can be used may include, but are not limited to, steel, aluminum, and / or FeNi36, also known as INVAR®, as well as any metal with a low coefficient of thermal expansion. The plunger may be made of a material with a high coefficient of thermal expansion. Thus, in this embodiment, a decrease in temperature can cause the syringe plunger to withdraw as the diameter of the syringe barrel decreases. Therefore, to balance these effects, the total volume change can be minimized.

[0077] (Characterization and control compensation) In some embodiments, it may be conceivable to characterize the effect of temperature changes on the volume of fluid pumped 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.

[0078] The injection pump may include one or more devices and / or components and / or systems for determining temperature. In some embodiments, the injection pump may include one or more thermistors or other temperature sensors for determining temperature. However, in other embodiments, various methods and / or devices and / or systems for directly or indirectly determining 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, the drive screw, any location on the drive system, or on the syringe barrel (including, but not limited to, those printed on the syringe barrel, plunger, and / or printed circuit board). 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 would potentially yield inaccurate 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 installed in the same location on the pump for user use so that they remain in place during characterization.

[0079] 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 delivering the fluid to a precise scale using an injection set / cannula connected to a heat chamber and reservoir / syringe. However, in other embodiments, this may be completed by delivering the fluid using an injection set / cannula connected to a heat chamber and reservoir / syringe, and then determining the position of the plunger inside the reservoir to determine the total volume of the delivered fluid.

[0080] In some embodiments, the temperature of the pump (taken at one or more locations and / or by one or more thermistors) may actually be measured, and the target position of the plunger may vary as a function of temperature and compensate for the thermal expansion of the syringe and / or plunger. The thermal expansion index may be determined by referring to characterization data, as described above. Thus, in some embodiments, the target position may be modified based on a lookup table or functional approximation of the volume change of the syringe with temperature.

[0081] In some embodiments, the injection pump delivers fluid as base or bolus delivery, and / or a variant thereof. Base delivery is a programmed rate or volume / time. The injection pump delivers volumes of fluid at predetermined intervals for a predetermined duration. The injection pump may also deliver bolus volumes. A bolus is a requested volume of fluid delivered immediately, i.e., when a request is made. One embodiment of the bolus and base delivery method is described in International Application PCT / US2009 / 060158, filed on October 9, 2009, currently titled Infusion Pump Assembly, International Publication WO2010 / 042814, published on April 15, 2010, and U.S. Patent Application US-2010-0094222, filed on October 10, 2008, currently titled Infusion Pump Assembly, U.S. Patent Application 12 / 249,882, filed on October 10, 2008, currently titled Infusion Pump Assembly, and all of these are incorporated herein by reference in their entirety. Furthermore, in several embodiments, for example, as described in U.S. Patent No. 7,498,563, issued March 3, 2009, titled Optical Displacement Sensor for Infusion Devices, which are incorporated herein by reference in their entirety, the infusion pump may determine the distance it must travel to deliver a volume of fluid, e.g., a base volume or bolus volume. Thus, in some embodiments of the infusion pump system, the infusion pump may use an optical displacement sensor to determine the distance the plunger moves during delivery. In some embodiments, the infusion pump determines a number of motor encoder counts per delivery to determine the movement of the plunger.

[0082] However, in various embodiments, the delivery method includes determining the distance the plunger must travel (which may be referred to as the target plunger position) to deliver a desired / target volume. As previously mentioned, this may be done by determining the number of motor encoder steps, or in other embodiments, by other means. In any case, the injection pump makes the determination of the plunger distance travel.

[0083] An embodiment of the characterization and control compensation method is as follows: The first step may be to characterize the volume delivered when the temperature changes. This volume may also 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 are a function of temperature (let's call it T). The volume change is a function β(T) associated with the temperature change.

[0084]

number

[0085] The coefficient β(T) can be determined as a function of temperature (as shown above), or, possibly, approximated as a constant β(T,x) determined as 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] [ka] Substituting this (letting x=0 when the plunger reaches its end and pushes out all the fluid in the syringe), the relationship is:

[0089]

number

[0090] In various embodiments, this correction may be carried out in different ways, including, but not limited to, the following. In some embodiments, the correction may be carried out by delivering based on an interval that may be more frequent than the base delivery interval, for example, once every three minutes, but not limited to this; in other embodiments, it may be more or less frequent. Furthermore, the syringe position may be adjusted based on temperature changes to maintain zero net volume delivered between regular deliveries, e.g., base and / or bolus deliveries. In some embodiments, this may be used for a low base rate, where the thermally driven volume may exceed regularly scheduled base deliveries. However, in some embodiments, this may require reversing the syringe direction to prevent delivery.

[0091] 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 predicted thermally driven volume delivery. In some of these embodiments, the correction may be limited so that the plunger can be driven in only one direction.

[0092] In some embodiments, the modeling may be variable, and assumptions may be made with respect to both the length and diameter of the syringe. Furthermore, assumptions may be made with respect to 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.

[0093] In some embodiments, adjusting the plunger target may include the step of 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 the possibility of backlash.

[0094] 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 temperature change 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 subtraction of 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 default modification may be determined to differ from that described.

[0095] 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 conforms to the shape factors of the injection pump hardware. The optical sensor has a sensing range that overlaps with the plunger displacement. In exemplary embodiments, any optical sensor may be used, including, but not limited to, the Sharp GP2S60 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 sensing of light intensity that varies as a function of distance / angle to the reflector. In some embodiments, the sensor is installed such that the reflective surface is the plunger.

[0096] 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. Together with temperature sensor information, this may provide additional data / information to determine temperature-dependent changes.

[0097] In some embodiments of an infusion pump system, including embodiments disclosed and described in U.S. Patent No. 7,498,563, issued on March 3, 2009, titled Optical Displacement Sensor for Infusion Devices; International Publication WO2010 / 042814, published on April 15, 2010, now titled Infusion Pump Assembly; International Application PCT / US2009 / 060158, filed on October 9, 2009, titled Infusion Pump Assembly; and U.S. Patent Application Publication US-2010-0094222, published on April 15, 2010, now titled Infusion Pump Assembly; and U.S. Patent Application 12 / 249,882, filed on October 10, 2008, titled Infusion Pump Assembly (all of which are incorporated herein by reference in their entirety), the infusion pump may include an optical displacement sensor. This sensor may be used to determine whether the plunger rod has moved forward or backward, and the distance of the movement. Using this displacement information, along with information from one or more temperature sensors, the effect of temperature changes on the plunger may be determined. This determination can then improve the accuracy of the control used to compensate for the temperature changes. This may include, but is not limited to, increasing the amount of fluid delivered by the sensed forward movement and / or the amount of fluid delivered by the sensed backward movement. In either case, the increase and / or decrease of 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.

[0098] In some embodiments, the injection pump system may include a system and / or method for adjusting the base rate and / or bolus amount based on temperature changes. Accordingly, 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 predetermined limited time 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 by a “decreasing gradient” mode, and the infusion pump may intentionally under-deliver in this mode, i.e., in an automatic rate reduction of the basal rate, and in some embodiments, a bolus may also be set to compensate for the expected additional delivery of fluid. As mentioned above, the determination of the rate change of insulin delivery may depend on the characterization of the infusion pump.

[0099] Subsequently, in some embodiments, for example, if the 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, a bolus may also be set to compensate for the expected additional delivery of fluid. As mentioned above, the determination of the rate change may depend on the characterization of the injection pump.

[0100] (Closed loop temperature compensation) For the purposes of this description, the term “forwarded” refers to the movement of the plunger within the syringe or reservoir body. Forward movement is not limited to movement in a particular direction. A syringe has an outlet end, which is the end of the syringe through which the fluid moves internally toward the outside.

[0101] In some embodiments, the system may include one or more devices and / or sensors that determine the pressure delivery of fluid, including the temperature effect on the syringe / plunger and / or user / cannula 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.

[0102] 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, "optical sensor") that fits the shape factor of the injection pump hardware is used. 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 one or more of the Sharp GP2S60, Sharp GP2S700, and Sharp GP2A240LC (all manufactured by Sharp Electronics Corporation, a US 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 the sensing of light intensity which varies as a function of distance / angle to the reflector. In some embodiments, the sensor is installed such that the reflective surface is a plunger.

[0103] 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. Together with temperature sensor information, this may provide additional data / information to determine temperature-dependent changes.

[0104] 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. Using this displacement information, along with information from one or more temperature sensors, the effect of temperature changes on the plunger may be determined. This determination can then improve the accuracy of the control used to compensate for the temperature changes. This may include, but is not limited to, a decrease in the amount of fluid delivered due to the sensed forward movement (i.e., a decrease in the volume of fluid scheduled to be delivered, i.e., the base rate, or requested to be delivered, i.e., the bolus amount), and / or an increase in the amount of fluid delivered due to the sensed backward movement.

[0105] In some embodiments, the injection pump may include an outlet valve and / or a occluder. Thus, in these embodiments, the injection pump includes at least one device to prevent the delivery of fluid from the syringe to the cannula and / or from the cannula to the user. In some embodiments, the device is activated when at least one temperature sensor sends a signal to a processor, which determines that a temperature change meets a threshold, i.e., the temperature change is large enough to affect the temperature-induced change in delivery. In some embodiments, this may activate the occluder and / or outlet valve to prevent fluid from flowing into or out of the syringe and / or cannula. In some embodiments, the occluder and / or outlet valve device is released when at least one temperature sensor sends a signal to a processor, which determines that a temperature change no longer meets a threshold, i.e., the temperature change is no longer large enough to affect the temperature-induced change in delivery. In some embodiments, this may release the occluder and / or outlet valve to allow fluid to flow from the syringe and / or the cannula and / or the user. Again, as mentioned above, in some embodiments, the plunger target may be adjusted in response to information from one or more temperature sensors.

[0106] In some embodiments, the occluder / outlet valve may be closed during intervals when the injection pump is not actively delivering fluid to prevent accidental fluid inflow into or outflow from the syringe / reservoir due to temperature changes. During the time 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 may be delivered.

[0107] Therefore, in these embodiments, the blocker / outlet valve may primarily act to prevent unintended fluid flow that may occur due to 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.

[0108] In some embodiments, the injection pump may include a compensating component. In some embodiments, the compensating component may change the volume difference in the syringe / reservoir while maintaining a pressure constant. Thus, in these embodiments, controller compensation may not need to compensate for temperature changes when the occluder / outlet valve is opened, since there will be no pressure accumulated from temperature changes.

[0109] In some embodiments, once a threshold temperature change is determined, the occluder / outlet valve may be closed, and the plunger rod may be left floating, i.e., the plunger rod may be engaged with and disengaged from the drive system. Thus, a pressure change will cause the plunger to float and reach equilibrium, and therefore, in response to a temperature change, it will make adjustments without the need for controller compensation.

[0110] 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 fluid flow. This information may be correlated with a delivery command to determine whether the fluid being delivered is the requested and / or appropriate delivery. In some embodiments, if flow is detected and it is determined that the delivered fluid is not the requested and / or appropriate 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 a predicted 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. Furthermore, 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 between the next scheduling or requested delivery (e.g., base 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 under- or over-delivery of the fluid.

[0111] In some embodiments, the injection pump may include one or more optical sensors. These sensors may be installed inside 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 predetermined intervals regardless of whether the drive system is activated. 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 unrequested delivery event could have occurred. The processor may correlate this information with at least one temperature sensor to determine whether the injection pump is subject to temperature-related influences. In some embodiments, the processor may alert the user. In some embodiments, the information may be used in a control algorithm to compensate for the effects of temperature changes, for example, using various embodiments discussed herein, but not limited to.

[0112] 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 to sense the 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, in some embodiments, be similar to those described in U.S. Patent Application No. 12 / 249,882, filed on October 10, 2008, published on April 15, 2010, now titled U.S. Patent Application No. US-2010-0094222, for Infusion Pump Assembly, and International Application PCT / US2009 / 060158, filed on October 9, 2009, published on April 15, 2010, now titled International Publication WO2010 / 042814, for Infusion Pump Assembly (all of which are incorporated herein by reference in their entirety). However, together with at least one temperature sensor, the strain beam may determine whether a particular temperature change has caused 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.

[0113] (temperature maintenance) As mentioned above, it may be desirable 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 aforementioned effects of temperature changes on the injection pump and fluid delivery.

[0114] 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 anywhere on the injection pump; however, in some embodiments, the heating device is located inside the injection pump housing. In some embodiments, the heating device is powered by a power supply or battery inside the injection pump. However, in some embodiments, the power supply may be outside the injection pump.

[0115] The heating source may be any desired heating source, however, in exemplary embodiments, the heating source may be a commercially available KAPTON® (Polyimide Film) Heater Kit from omega.com®, 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 and supply 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 differ. In some embodiments, it may be desirable to maintain a higher temperature.

[0116] In some embodiments, the syringe / reservoir may be contained within a metal case in the injection pump. The metal case can increase heat conduction between the heating element and the syringe / reservoir.

[0117] 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.

[0118] In some embodiments, at least one heating element may further 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.

[0119] In some embodiments, it may be desirable to use the user's body as a heat sink and mount the infusion 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:

[0120] For example, a hook-and-loop fastener system, such as those supplied by VELCRO® USA Inc. (Manchester, NH), may be used to allow for easy attachment / removal of the infusion pump by the user. Therefore, the adhesive patch may be attached to the user's skin and may include outward-facing hook or loop surfaces. Furthermore, the surface of the infusion pump 114 may include complementary hook or loop surfaces. Depending on the separation resistance of the specific type of hook-and-loop fastener system employed, the strength of the hook and loop connection may be stronger than the adhesive strength to the skin connection. Therefore, various hook and loop surface patterns may be used to adjust the strength of the hook and loop connection.

[0121] 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 the injection pump housing is covered with “loop” material. Thus, the strength of the hook and loop connection may be adjusted by varying the pattern (i.e., amount) of “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 “hook” material (as shown in Figure 10A), multiple concentric circles 222, 224 of “hook” material (as shown in Figure 10B), multiple radial spokes 226 of “hook” material (as shown in Figure 10C), multiple radial spokes 228 of “hook” material combined with a single outer circle 230 of “hook” material (as shown in Figure 10D), and multiple radial spokes 232 of “hook” material combined with multiple concentric circles 234, 236 of “hook” material (as shown in Figure 10E).

[0122] In another embodiment, a holder, pouch, bag, container, or other type of housing (collectively referred to as “holder”) may be sized to accommodate an injection pump. In some embodiments, the holder may be constructed to include multiple layers, 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 made of a highly absorbent material. In some embodiments, the holder may include one or more containers of isopropyl alcohol, which, once employed, can be absorbed into the highly absorbent material of the holder and provide 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.

[0123] In some embodiments, the holder may include one or more temperature measuring devices and / or temperature sensors that can 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 containers of alcohol, and / or alert 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 triggered by reaching a threshold temperature change. Therefore, in some embodiments, the holder may provide a closed-loop system to maintain the temperature for the injection pump.

[0124] Next, referring 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 a screen and / or input assembly (including, but not limited to, buttons, sliders, and / or jog wheels). In some embodiments, the flap may be secured and closed using a hook-and-loop fastener system. In other embodiments, the flap may be secured using any other fastener system, including, but not limited to, snaps, buttons, magnetic closures, and zippers.

[0125] In some embodiments, the holder 500 may be attached to a strap 508 designed to be attached to a 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. As shown in Figure 12, the holder 500 may be attached to any location desired by the user, although it may be attached to a location desired by the user.

[0126] 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 referred to as a “belt clip” or another type of clip, configured to fit securely and detachably across a belt, handle, set of clothing, or other. In some embodiments, the holder 500 may further include an opening 514 through which tubes 516 will fit. In some embodiments, an injection pump (not shown) is contained inside the holder 500, and the holder may be mounted close to a user insertion site (not shown) so that the smallest tubes 516 are exposed to the external temperature. Thus, embodiments of the holder 500 including an opening 514 for tubes may be useful for maintaining the temperature of the tubes 516 and / or the fluid in the tubes.

[0127] In some embodiments, the infusion pump may be attached to and maintained on the user's body using a plastic material, such as Press n' Seal, or another material with similar behavior. 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 maintained in place against the skin through an inner pocket, bra pocket, etc.

[0128] 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 also within the scope of the invention. Furthermore, various methods, systems, and apparatus for maintaining the temperature of an infusion pump may include at least one temperature sensor.

[0129] (Insulin temperature) This specification describes various methods, systems, devices, and / or apparatus for maintaining the temperature of an infusion pump. Inherent in at least some of these embodiments is the maintenance of the injectable fluid / insulin temperature. It is well known that insulin manufacturers recommend that the insulin temperature not exceed high or low temperatures. Furthermore, once the vial is used, it may be beneficial to maintain rapid action at room temperature / ambient temperature (e.g., 59 to 86 degrees Fahrenheit) (e.g., HUMALOG®, NOVOLOG®), meaning that manufacturers recommend storing insulin in a refrigerated area, e.g., 36 to 46 degrees Fahrenheit, until the vial is used. From that point onward, it is recommended that the vial be stored at room temperature.

[0130] Since insulin can become less effective or ineffective when it reaches unrecommended temperatures, it can be beneficial for users to know whether their insulin has been stored properly, whether during transport, refrigeration, or use.

[0131] Referring to Figure 14, in one embodiment, the adhesive thermometer 520 may be placed on a fluid vial 522, and in some embodiments, it may be placed on an insulin vial. The thermometer can 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, when the temperature reaches a maximum or minimum temperature (which is predetermined and in some embodiments may be 35 and 87 degrees Fahrenheit, respectively), the thermometer becomes irreversible, thus instantly indicating to the user that the insulin has reached its maximum or minimum temperature.

[0132] Any adhesive thermometer containing an irreversible temperature label, such as Non-Reversible Temperature Labels, 3 Temperature Ranges, or other similar temperature labels, available from omega.com (registered trademark) under part number TL-3, may be used. As described above, in some embodiments, a reversible label or a label having both reversible and irreversible components may be used.

[0133] 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. Other embodiments, in addition to the exemplary embodiments illustrated and described herein, are also envisioned within the scope of the invention. Modifications and substitutions by those skilled in the art are also considered to be within the scope of the invention.

Claims

[Claim 1] The invention as described in the drawings of the present application.

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