Drug delivery pump for a redundant staggered glucose sensor insulin dosing system

Abstract

The disease management system includes a drug delivery pump configured to deliver a drug from a drug pouch to a patient. The drug delivery pump may include one or more plungers configured to block a flow path of the drug from a drug container to the patient, one or more muscle wires, and one or more disk-shaped springs. The one or more muscle wires and disk-shaped springs may be configured to move the one or more plungers to block and unblock the flow path of the drug from the drug pouch to the patient.

Description

[Technical field]

[0001] The general field of the present disclosure is glucose sensing and disease management systems. [Background technology]

[0002] Diabetes is a chronic disease that affects many people, both adults and children. Management of diabetes can include measuring glucose in the patient's blood and / or interstitial spaces, including interstitial fluid, and administering insulin to the patient. A closed-loop insulin delivery system includes both a sensor for taking glucose measurements from the interstitial spaces, including the patient's blood and / or interstitial fluid, and an insulin delivery device that delivers insulin to the patient based on the glucose measurements. The closed-loop insulin delivery system can allow people affected by diabetes to go about their daily lives with much less worry about their insulin or glucose, which can greatly improve the quality of life for diabetic patients. Summary of the Invention [Means for solving the problem]

[0003] The various aspects of the systems, methods, and devices within the scope of the appended claims each have several aspects, none of which is responsible for the desired attributes described herein. Without limiting the scope of the appended claims, several superior features are described herein.

[0004] The disease management device may include a patch or a patient-worn insulin pump. In some embodiments, the pump may be configured to be lightweight and compact. For example, the pump may be configured to have a small area and occupy a minimal footprint in the device. Similarly, the pump may be lightweight to minimize the weight of the device. In some embodiments, the device may be configured to operate at low or ultra-low power. In some embodiments, the pump may operate on a cycle-by-cycle basis, which may reduce the speed of the pump and / or maximize the accuracy and precision of the pump. Similarly, the pump may be configured to emit a minimal amount of energy or heat, which may increase the efficiency of the pump and the device.

[0005] The disease management device may include a drug delivery pump configured to deliver the drug from the drug pouch to the patient, the drug delivery pump may include one or more occluders, also referred to herein as plungers or pistons, configured to block a flow path of the drug from the drug container to the patient when in a non-retracted position, and one or more wires, such as muscle wires, operably connected to the one or more occluders, where at least one of the one or more occluders is configured to open the flow path of the drug when the one or more wires are retracted. The disease management device may also include one or more springs configured to provide a retraction pressure to at least one of the one or more occluders, such that when the associated wire is not retracted, the one or more occluders are retracted to a non-retracted position and block the flow path of the drug. The muscle wire may include a nitinol wire that may retract itself when electricity is applied. The one or more springs may include one or more disc-shaped springs. The one or more springs may include silicon.

[0006] The device may include an analyte sensor. The medication may include at least one of insulin, glucagon, or any other administrable medication.

[0007] The one or more occluders may include first, second, and third occluders configured to block the flow path of the drug in first, second, and third portions of the flow path, respectively. The one or more hardware processing devices may be configured to engage the first, second, and third occluders in a pattern with the one or more muscle wires to move the drug from the drug pouch through the flow path to the patient. To engage the first, second, and third occlusions in a pattern, the one or more hardware processing devices can be configured to apply a first electrical signal by the first muscle wire to cause the first occlusion to open a flow path at a first portion, to stop applying the first electrical signal to the first muscle wire to cause the first occlusion to retract to a non-retracted position and block the flow path at the first portion, to apply a second electrical signal to the second muscle wire to cause the second occlusion to open a flow path at a second portion, to stop applying the second electrical signal to the second muscle wire to cause the second occlusion to retract to a non-retracted position and block the flow path at the second portion, and to apply a third electrical signal to a third wire of the one or more muscle wires to cause the third occlusion to open a flow path at the third portion.

[0008] In certain aspects, a disease management device includes a drug delivery pump configured to deliver a drug from a drug pouch to a patient, the drug delivery pump including one or more occluders configured to block a flow path of the drug from the drug container to the patient when in a first position, and one or more wires operably connected to the one or more occluders, where at least one of the one or more occluders is configured to open the flow path of the drug when the one or more wires are actuated.

[0009] In certain embodiments, the device further comprises one or more springs configured to provide a retraction pressure to at least one of the one or more occlusions such that the one or more occlusions are positioned to block the flow path of the drug when the coupled wire is not actuated.

[0010] In certain embodiments, the one or more occlusions are one or more plungers.

[0011] In certain embodiments, the one or more wires are one or more muscle wires that expand or contract when electricity is applied to them.

[0012] In certain embodiments, the occlusion occludes the flow of drug when the one or more wires are not actuated.

[0013] In certain aspects, the disease management device comprises an analyte sensor.

[0014] In certain embodiments, the drug comprises at least one of insulin or glucagon.

[0015] In certain embodiments, the one or more springs comprise a disc spring.

[0016] In certain embodiments, the one or more springs comprise silicon.

[0017] In certain embodiments, the one or more muscle wires comprise a Nitinol wire.

[0018] In certain embodiments, the one or more muscle wires comprise a nickel-titanium alloy.

[0019] In certain embodiments, the one or more occlusions comprise first, second, and third occlusions configured to block the flow path of the drug at first, second, and third locations, respectively, of the flow path.

[0020] In certain aspects, the disease management system comprises one or more hardware processing devices configured to actuate and engage at least one of the one or more occlusions in a pattern on the one or more wires to move the drug from the drug pouch to the patient.

[0021] In certain aspects, the one or more hardware processing devices are configured to actuate the first and second occlusions in a pattern, the one or more hardware processing devices being configured to: apply a first electrical signal to the first wire to cause the first occlusion to open a flow path at a first portion through the first wire; stop applying the first electrical signal to the first wire to cause the first spring to apply a retraction pressure to the first occlusion so that the first occlusion is retracted to a non-retracted position and blocking the flow path at the first portion; apply a second electrical signal to the second wire to cause the second occlusion to open a flow path at a second portion; and stop applying the second electrical signal to the second wire to cause the second spring to apply a retraction pressure to the second occlusion so that the second occlusion is retracted to a non-retracted position and blocking the flow path at the second portion.

[0022] In certain aspects, the one or more hardware processing devices are configured to actuate the first, second, and third occlusions in a pattern, and the one or more hardware processing devices are configured to: apply a first electrical signal to a first wire to cause the first occlusion to open a flow path at a first portion through the first wire; stop applying the first electrical signal to the first wire to cause the first spring to apply a retraction pressure to the first occlusion so that the first occlusion is retracted to a non-retracted position and blocking the flow path at the first portion; apply a second electrical signal to the second wire to cause the second occlusion to open a flow path at a second portion; stop applying the second electrical signal to the second wire to cause the second spring to apply a retraction pressure to the second occlusion so that the second occlusion is retracted to a non-retracted position and blocking the flow path at the second portion; and apply a third electrical signal to a third wire of the one or more wires to cause the third occlusion to open a flow path at a third portion.

[0023] In certain embodiments, the one or more occlusions are configured to substantially or partially occlude the flow path of the drug.

[0024] In certain aspects, the drug delivery pump further comprises a feedback control system.

[0025] In certain aspects, the disease management system implements a method for delivering a liquid medication from a medication pouch to a patient, the method including blocking a flow path of the liquid medication from a liquid medication container to the patient when one or more occlusions are in a non-contracted position, and constricting the one or more occlusions to open at least a portion of the flow path.

[0026] In certain embodiments, the disease management system provides retraction pressure to at least one of the one or more occlusions by one or more springs to retract the one or more occlusions to a non-retracted position and block the flow path of the liquid medication.

[0027] In certain aspects, the method performed further includes sensing one or more physiological parameters of the patient with an analyte sensor.

[0028] In certain aspects, the method performed further comprises a step including sensing one or more physiological parameters of the patient with an analyte sensor.

[0029] In certain embodiments, the liquid medication comprises at least one of insulin or glucagon.

[0030] In certain embodiments, the one or more springs comprise silicon.

[0031] In certain embodiments, the one or more obturators comprise one or more plungers.

[0032] In certain embodiments, the step of contracting the one or more occlusions includes using a muscle wire to contract the one or more occlusions.

[0033] In certain embodiments, the one or more muscle wires comprise a Nitinol wire.

[0034] In certain embodiments, the one or more occlusions include first, second, and third occlusions configured to block the flow path of the liquid medicament in first, second, and third portions of the flow path, respectively.

[0035] In certain embodiments, the disease management system includes one or more hardware processors that engage the first, second, and third occluders in a pattern with the one or more muscle wires to allow the liquid medication to flow from the medication pouch to the patient.

[0036] In certain aspects, the method performed further includes applying a first electrical signal by the first muscle wire to the first occlusion to cause the first occlusion to open a flow path at a first portion; ceasing application of the first electrical signal to the first muscle wire to cause the first spring to apply a retraction pressure to the first occlusion to retract to a non-contracted position and block the flow path at the first portion; applying a second electrical signal to the second muscle wire to cause the second occlusion to open a flow path at a second portion; ceasing application of the second electrical signal to the second muscle wire to cause the second spring to apply a retraction pressure to the second occlusion to retract to a non-contracted position and block the flow path at the second portion; and applying a third electrical signal to a third wire of the one or more muscle wires to cause the third occlusion to open a flow path at a third portion.

[0037] In certain aspects, a method for engaging a system of occluders configured to block a flow path of a liquid drug from a drug container to a patient includes applying a first electrical signal by a first muscle wire to a first occluder to cause a first occluder to open a flow path at a first portion of the flow path; ceasing application of the first electrical signal to the first muscle wire to cause a first spring to apply a retraction pressure to the first occluder so that the first occluder is retracted to a non-retracted position and blocks the flow path at the first portion of the flow path; applying a second electrical signal to the second muscle wire to cause a second occluder to open a flow path at a second portion of the flow path; ceasing application of the second electrical signal to the second muscle wire to cause the second spring to apply a retraction pressure to the second occluder so that the second occluder is retracted to a non-retracted position and blocks the flow path at the second portion; and applying a third electrical signal to a third wire to cause a third occluder to open a flow path at a third portion.

[0038] In certain aspects, a muscle wire pump system configured to manage a liquid drug flow path is provided, the system comprising a controller configured to control operation of the pump by operating at least one occlusion in the liquid drug flow path, and one or more muscle wires coupled to at least one of the at least one occlusion, the one or more muscle wires configured to receive an electrical signal to cause contraction of at least one of the at least one occlusion to retract the at least one occlusion to allow an unobstructed liquid drug flow path.

[0039] In certain embodiments, the muscle wire pump comprises one or more springs coupled to a plate forming an assembly with at least one occluder.

[0040] In certain embodiments, the plate includes one or more holes configured to receive at least a portion of at least one occlusion.

[0041] In certain embodiments, the one or more springs comprise a disc spring.

[0042] In certain aspects, a method is provided for engaging a system of occluders configured to block a flow path of a liquid drug from a drug container to a patient, the method including applying a first electrical signal to a first muscle wire to cause a first occluder to open a flow path through the first muscle wire at a first portion of the flow path, ceasing application of the first electrical signal to the first muscle wire to cause a first spring to apply a retraction pressure to the first occluder such that the first occluder is retracted to a non-retracted position, blocking the flow path at the first portion of the flow path, and applying a second electrical signal to a second muscle wire to cause a second occluder to open a flow path at a second portion of the flow path.

[0043] In certain aspects, a method for monitoring a device with a feedback mechanism includes connecting conductive wires to a component of the device and to a feedback contact portion, initiating a signal when the feedback contact portion contacts a feedback layer, analyzing the signal, and controlling the device based on an analysis of the signal.

[0044] In certain embodiments, the signal includes the status of a component of the device.

[0045] In certain aspects, the disease management device comprises a drug delivery pump configured to deliver a drug from a drug pouch to a patient, the drug delivery pump comprising at least two pistons configured to pump the drug from a drug container to the patient, and at least two wires, at least one operatively connected to each one of the at least two pistons, wherein when the one or more wires are actuated, at least one of the one or more pistons is configured to open a drug flow path and create a negative pressure to draw the drug into the flow path.

[0046] In certain embodiments, the device further comprises two or more springs configured to provide a retraction pressure to at least one of the at least two or more pistons such that when the connected wire is not actuated, the one or more pistons are repositioned to apply positive pressure to the drug and block the flow path of the drug when they are not fully retracted.

[0047] In certain embodiments, the one or more pistons are one or more plungers.

[0048] In certain embodiments, the one or more wires are one or more muscle wires that expand or contract when electricity is applied to them.

[0049] In certain embodiments, the piston occludes the flow of drug when the one or more wires are not actuated.

[0050] In certain aspects, the device further comprises an analyte sensor.

[0051] In certain embodiments, the drug comprises at least one of insulin or glucagon.

[0052] In certain embodiments, the one or more springs comprise a disc spring.

[0053] In certain embodiments, the one or more springs comprise silicon.

[0054] In certain embodiments, the one or more muscle wires comprise a Nitinol wire.

[0055] In certain embodiments, the one or more muscle wires comprise a nickel-titanium alloy.

[0056] In certain embodiments, the at least two pistons comprise first, second, and third pistons configured to block the flow path of the drug at first, second, and third locations of the flow path, respectively.

[0057] In certain embodiments, the device further comprises one or more hardware processing units configured to actuate and engage at least one of the at least two or more pistons in a pattern with the at least two or more wires to move the drug from the drug pouch to the patient.

[0058] In certain embodiments, the one or more hardware processing devices are configured to actuate the first and second pistons in a pattern, and the one or more hardware processing devices are configured to substantially simultaneously apply electrical signals to the first wire and the second wire to cause the first piston to open a flow path at a first portion via the first wire and the second piston to open a flow path at a second portion via the second wire, such that the first and second pistons generate a negative pressure configured to draw drug into the flow path, and stop applying the electrical signal to the first wire to cause the first spring to apply a retraction pressure to the first piston such that the first piston is retracted to a non-retracted position, blocking the flow path at the first portion.

[0059] In certain embodiments, the one or more hardware processing devices are configured to actuate the first, second, and third pistons in a pattern, and the one or more hardware processing devices are configured to: substantially simultaneously apply electrical signals to the first wire and the second wire to cause the first piston to open a flow path at a first position via the first wire to create negative pressure and the second piston to open a flow path at a second position via the second wire to create negative pressure; stop applying the electrical signal to the first wire to cause the first spring to apply a retraction pressure to the first piston so that the first piston is retracted to a non-retracted position and blocks the flow path at a first portion; and substantially simultaneously apply a second electrical signal to the third wire and stop applying the electrical signal to the second wire to cause the third piston to open a flow path at a third position and stop applying the electrical signal to the second wire to cause the second spring to apply a retraction pressure to the second piston so that the second piston is retracted to a non-retracted position, applying positive pressure to the drug and blocking the flow path at a second portion.

[0060] In certain embodiments, the one or more pistons are configured to substantially or partially occlude the drug flow path.

[0061] In certain aspects, the drug delivery pump further comprises a feedback control system.

[0062] In certain aspects, a method for delivering a liquid drug from a drug pouch to a patient includes blocking a flow path of the liquid drug from a liquid drug container to a patient when one or more pistons are in a non-retracted position, and retracting the one or more pistons to open at least a portion of the flow path and create a negative pressure to draw the drug into the flow path.

[0063] In certain aspects, the method further includes providing a retraction pressure to at least one of the one or more pistons by one or more springs to retract the one or more pistons to a non-retracted position, blocking the flow path of the liquid drug and applying a positive pressure to the drug in the flow path.

[0064] In certain aspects, the method further includes sensing one or more physiological parameters of the patient with an analyte sensor.

[0065] In certain aspects, the method further includes sensing one or more physiological parameters of the patient with an analyte sensor.

[0066] In certain embodiments, the liquid medication comprises at least one of insulin or glucagon.

[0067] In certain embodiments, the one or more springs comprise silicon.

[0068] In certain embodiments, the one or more pistons include one or more plungers.

[0069] In certain embodiments, the step of contracting the one or more pistons includes using muscle wires to contract the one or more pistons.

[0070] In certain embodiments, the one or more muscle wires comprise a Nitinol wire.

[0071] In certain embodiments, the one or more pistons include first, second, and third pistons configured to block the flow path of the liquid medicament in first, second, and third portions of the flow path, respectively.

[0072] In certain embodiments, the method further comprises one or more hardware processing devices that engage the first, second, and third pistons in a pattern with the one or more muscle wires to cause the liquid drug to flow from the drug pouch to the patient.

[0073] In certain aspects, the method further includes applying an electrical signal to the first wire and the second wire to cause the first piston to open a flow path through the first wire and create a negative pressure to allow the drug to flow to the flow path in a first portion and the second piston to open a flow path through the second wire in a second portion; ceasing the application of the electrical signal to the first wire to cause the first spring to apply a retraction pressure to the first piston so that the first piston is retracted to a non-retracted position, applying a positive pressure to the drug and blocking the flow path in the first portion; applying a second electrical signal to the third wire to cause the third piston to open a flow path in a third portion and ceasing the application of the electrical signal to the second wire to cause the second spring to apply a retraction pressure to the second piston so that the second piston is retracted to a non-retracted position, applying a positive pressure to the drug in the flow path and blocking the flow path in the second portion.

[0074] In certain aspects, a method for engaging a system of pistons configured to deliver a drug to a patient and block a flow path of a liquid drug from a drug container to a patient includes the steps of: applying an electrical signal to a first wire and a second wire to substantially simultaneously cause a first piston to open a flow path at a first portion via the first wire and a second piston to open a flow path at a second portion via the second wire; ceasing application of the electrical signal to the first wire to cause a first spring to apply a retraction pressure to the first piston such that the first piston is retracted to a non-retracted position and blocks the flow path at the first portion; and substantially simultaneously applying a second electrical signal to a third wire and ceasing application of the electrical signal to the second wire to cause a third piston to open a flow path at a third portion and to cause the second spring to apply a retraction pressure to the second piston such that the second piston is retracted to a non-retracted position and blocks the flow path at the second portion.

[0075] In certain aspects, a muscle wire pump system configured to manage a liquid drug flow path comprises a controller configured to control operation of the pump by operating at least one piston in the liquid drug flow path, and one or more muscle wires coupled to at least one of the at least one piston, the one or more muscle wires configured to receive an electrical signal and cause contraction of at least one of the at least one piston to retract the at least one piston to enable an unobstructed liquid drug flow path and create a negative pressure to draw the drug into the flow path.

[0076] In certain embodiments, the muscle wire pump system further comprises one or more springs coupled to the plate forming an assembly with the at least one piston.

[0077] In certain embodiments, the plate includes one or more holes configured to receive at least a portion of at least one piston.

[0078] In certain embodiments, the one or more springs comprise a disc spring.

[0079] In certain aspects, a method for engaging a system of pistons configured to block a flow path of a liquid drug from a drug container to a patient includes the steps of substantially simultaneously applying electrical signals to a first wire and a second wire to cause a first piston to open a flow path at a first portion via a first wire and a second piston to open a flow path at a second portion via a second wire to create a negative pressure to draw drug into the flow path, and ceasing application of the electrical signal to the first wire to cause a first spring to apply a retraction pressure to the first piston such that the first piston is retracted to a non-retracted position, blocking the flow path at the first portion.

[0080] These and other example aspects of the present disclosure are set forth in the following detailed description and appended claims, as well as the accompanying drawings. [Brief description of the drawings]

[0081] [Figure 1] FIG. 1 is a diagram of an example disease management system that may be part of a disease management environment or may be used as an interleaved device. [Diagram 2] FIG. 1 is a diagram of an example implementation of a disease management system. [Diagram 3] FIG. 1 is a perspective view of a muscle wire pump of an example disease management system. [Figure 4] FIG. 13 is a diagram of components of an example muscle wire pump of another example disease management system. [Figure 5A] FIG. 13 is a diagram of an occlusion and a silicone membrane that acts as a spring component of a muscle wire pump of an example disease management system. [Figure 5B] FIG. 13 is a diagram of an occlusion and a silicone membrane that acts as a spring component of a muscle wire pump of an example disease management system. [Figure 5C] FIG. 13 is a diagram of an occlusion and a silicone membrane that acts as a spring component of a muscle wire pump of an example disease management system. [Figure 5D]FIG. 13 is a diagram of an occlusion and a silicone membrane that acts as a spring component of a muscle wire pump of an example disease management system. [Figure 6] FIG. 13 is a diagram of an example connection of an occluder and a silicone membrane acting as a spring component to an example fluid line of an example muscle wire pump. [Figure 7A] 13A-13C are diagrams of example functionality of the spring components of an example muscle wire pump. [Figure 7B] 13A-13C are diagrams of example functionality of the spring components of an example muscle wire pump. [Figure 7C] 13A-13C are diagrams of example functionality of the spring components of an example muscle wire pump. [Figure 8] 1A-1C are diagrams of an example operation of an example muscle wire pump. [Figure 9] FIG. 1 is a diagram of an example flow path of a muscle wire pump. [Figure 10] FIG. 1 is a diagram of an example feedback control system that may be part of a muscle wire pump. [Figure 11] FIG. 1 is a diagram of an example muscle wire pump including a feedback control system. [Figure 12] FIG. 2 is a diagram of an example muscle wire pump. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0082] In accordance with common practice, the various features illustrated in the drawings may not be drawn to scale. Thus, dimensions of the various features may be arbitrarily expanded or reduced for clarity. Also, some of the drawings may be simplified for clarity. Thus, the drawings may not depict all of the components or methods of a given apparatus (e.g., device). Finally, like reference numerals may be used to refer to like features throughout the specification and figures.

[0083] Although certain preferred embodiments and examples are disclosed below, the subject matter of the present invention extends beyond the embodiments specifically disclosed to other alternative embodiments and / or uses, as well as to modifications and equivalents thereof. Thus, the scope of claims that may arise from this specification is not limited by any of the specific embodiments described below. For example, in any method or process disclosed herein, the acts or operations of the method or process can be performed in any suitable sequence and are not necessarily limited to any specific disclosed sequence. Furthermore, although various operations may be described as multiple separate operations in a manner that may be useful in understanding a particular embodiment, the order of description should not be construed to imply that these operations are order-dependent. Also, the structures, systems, and / or devices described herein may be embodied as integrated components or as separate components. For purposes of comparing various embodiments, specific embodiments and advantages of these embodiments are described. Not necessarily all such aspects or advantages are achieved by any particular embodiment. Thus, for example, various aspects may be performed in a manner to achieve or optimize one advantage or group of advantages as taught herein, without necessarily achieving other aspects or advantages, as may also be taught or suggested herein.

[0084] A. Exemplary Disease Control Systems FIG. 1 illustrates a block diagram of an example disease management system 1101. In some examples, the disease management system 1101 may be part of a disease management environment, as described above. The disease management system 1101 may be configured to measure one or more physiological parameters of a patient (such as pulse, skin temperature, or other values), measure one or more analytes present in the patient's blood (such as glucose, lipids, or other analytes), and administer medications (such as insulin, glucagon, or other medications). In some examples, the disease management system 1101 may be configured to communicate with one or more hardware processing devices that may be external to the disease management system 1101, such as a cloud-based processing device or a user device. The disease management system 1101 may include an NFC tag to assist in authentication and pairing with a user device (e.g., a smartphone or smartwatch), Bluetooth® communication with additional disease management systems or devices, and Bluetooth® communication with a paired user device running an associated control application. To aid in ease of use and safe patient interaction, the system can incorporate user input through a tap-detecting accelerometer and can provide feedback via an audio speaker, tactile vibration, and / or visual indicators. The system can operate on battery power to aid in both shelf life and reliable operation once applied to the patient. Battery life can be managed through the control of several scheduled sleep and power consumption levels. To aid in this reliability, a controller can monitor several system health parameters, including the temperature of the contained drug and the ambient temperature for the life of the device.

[0085] As shown in FIG. 1, the controller 1138 of the disease management system 1101 may be configured to communicate with and control one or more components of the disease management system 1101. The controller 1138 may include one or more hardware processors, such as a printed circuit board (PCB). The controller 1138 may be configured to communicate with peripheral devices or components to assist in accurate measurement of physiological parameters and blood analytes, such as the patient's pulse, temperature, and blood glucose, using detector electronics. The controller 1138 may then calculate a dosage or receive a calculated dosage value and administer a drug, such as insulin, by actuation of an actuated pump. The controller 1138 may record device activity and communicate the recorded data to a non-volatile secure storage space. At the end of the life of the device or system, the controller may be configured to create a data recovery module to lock operation and, if necessary, allow authorized access to the recorded data.

[0086] The disease management system 1101 may include an analyte sensor 1120. The analyte sensor 1120 may be configured to detect an analyte in the patient's blood. For example, the analyte sensor 1120 may include a glucose sensing probe configured to pierce a surface of the skin 1121. In some examples, the disease management system 1101 may include multiple analyte sensors 1120 to detect one or more analytes. In some examples, the analyte sensor 1120 may be configured to detect multiple analytes. The analytes sensed may include, but are not limited to, glucose, insulin, and other analytes. The analyte sensor 1120 may be configured to communicate with an analyte detector 1126. The analyte detector 1126 may be configured to receive signals of the one or more analyte sensors 1120 to measure one or more analytes in the patient's blood. The analyte detector 1126 may be configured to communicate with a controller 1138. For example, the analyte detector 1126 may be configured to transmit analyte values ​​to the controller 1138, receive control signals from the controller, etc.

[0087] The disease management system 1101 may include a drug catheter 1122. The drug catheter 1122 may be configured to administer a drug to the patient, including but not limited to insulin. The drug catheter 1122 may receive a drug from a drug bladder 1128 configured to accommodate the drug to be administered. The drug bladder 1128 may be configured to accommodate a drug for an extended period of time, such as one day, three days, six days, or longer. The drug bladder 1128 may be configured to accommodate a particular type of drug, such as insulin. In some examples, the disease management system 1101 may include multiple drug bladders 1128 for one or more containers of the same or different drugs. In some examples, the disease management system 1101 may be configured to mix drugs from the drug bladders 1128 prior to administration to the patient. A pump 1130 may be configured to administer the drug from the bladder 1128 through the insulin catheter 1122 to the patient. The pump 1130 may be, but is not limited to, a pump as described herein.

[0088] The disease management system 1101 may optionally include a physiological sensor 1124. The physiological sensor 1124 may include a pulse rate sensor, a temperature sensor, pulse oximetry, etc., or a combination thereof. In some examples, the disease management system 1101 may be configured to include multiple physiological sensors. The physiological sensor 1124 may be configured to communicate with a physiological detector 1134. The physiological detector 1134 may be configured to receive a signal of the physiological sensor 1124. The physiological detector 1134 may be configured to measure or determine and communicate a physiological value from the signal. The physiological detector 1134 may be configured to communicate with a controller 1138. For example, the physiological detector 1134 may be configured to transmit a measured physiological value to the controller 1138 and receive a control signal from the controller, for example.

[0089] The disease management system 1101 may include one or more local user interface components 1136. For example, the local user interface components 1136 may include, but are not limited to, one or more of an optical display, a haptic motor, an audio speaker, and a user input detector. In some examples, the optical display may include LED lights configured to display multiple colors. In some examples, the optical display may include a digital display of information associated with the disease management system 1101, including, but not limited to, device status, drug status, patient status, measured analyte or physiological values, or the like, or a combination thereof. In some examples, the user input detector may include an inertial measurement unit, a tap detector, a touch display, or other components configured to accept and receive user input. In some examples, the audio speaker may be configured to convey an audible alert regarding the device status, drug status, user status, or the like, or a combination thereof. The controller 1138 may be configured to communicate with one or more local interface components 1136 by receiving user input from one or more user input components or by sending control signals, for example, to operate a haptic motor, to generate output to an optical display, to generate an audio output, or to control one or more of the local user interface components 1136.

[0090] The disease management system 1101 may include one or more communication components 1140. The communication components 1140 may include, but are not limited to, one or more radios configured to emit Bluetooth, cellular, Wi-Fi, or other wireless signals. In some examples, the communication components 1140 may include a port for a wired connection. The disease management system 1101 may also include an NFC tag 1142 to facilitate communication with one or more hardware processing devices. The one or more communication components 1140 and the NFC tag 1142 may be configured to communicate with the controller 1138 to transmit and / or receive information associated with the disease management system 1101. For example, the controller 1138 may communicate drug information and measured values ​​to an external device through the one or more communication components 1140. The controller 1138 may also receive instructions associated with measurement sampling rates, drug delivery, or other information associated with the operation of the management system 1101 from one or more external devices through the one or more communication components 1140.

[0091] The disease management system 1101 may include one or more power components 1144. The power components may include, but are not limited to, one or more batteries and power management components such as a voltage regulator. Power from the one or more power components 1144 may be accessed by a controller and / or other components of the disease management system 1101 to operate the disease management system 1101.

[0092] The disease management system 1101 may have one or more power modes and sleep modes to help regulate power usage. For example, the disease management system 1101 may have a sleep mode. The sleep mode may be a very low power mode with minimal functionality such as an RTC (or real time clock) and alarms to wake the system, take a temperature measurement of the system, etc. In another example, the disease management system 1101 may include a measure temperature mode that may correspond to a low power mode with reduced functionality. The measure temperature mode may be initiated by an RTC where the system is configured to take a temperature measurement, store the value, and return the system to sleep mode. In another example, the disease management system 1101 may include a wake-up mode. The wake-up mode may be initiated by an NFC device to allow the system to pair with an external device, such as by Bluetooth. If a pairing event does not occur, the system may return to sleep mode. In another example, the disease management system 1101 may include a pairing mode. The pairing mode may be initiated by an NFC device. When a control application is recognized, the system can pair with the application and proceed to set the system to an on condition and communicate to the cloud or other external device to establish initial data transfer. In other examples, the disease management system 1101 can include a sleep mode where the system is configured to enter a lower power mode between measurements. In other examples, the disease management system 1101 can include a data acquisition mode where the system is configured to enter a medium power mode where data acquisition is performed. In other examples, the disease management system 1101 can include a parameter calculation mode where the system is configured to enter a medium power mode where parameter calculations, such as blood glucose calculations, are performed and data is sent to an external device and / or cloud. In other examples, the disease management system 1101 can include a pump mode where the system is configured to enter a higher power mode where the pump draws power to deliver medication to the patient.

[0093] The disease management system 1101 may include one or more connector test points 1146. The connector test points may be configured to assist in programming, debugging, testing, or other access of the disease management system 1101. In some examples, the connector test points 1146 may be, for example, a GPIO spare, a UART receiver, a UART transmitter, or the like, or a combination thereof.

[0094] FIG. 2 illustrates an example implementation of a disease management system 1103 and an applicator 1190 for applying the disease management system 1103 to a patient. The disease management system 1103 may include any one or more of the features described above with respect to the disease management system 1101, in addition to the features described below. In the illustrated example, the applicator 1190 may be configured to mate with the disease management system 1103. In some examples, the applicator 1190 may include a safety button 1192 for release or other interaction with the applicator 1190. In the illustrated example, the disease management system 1103 may include one or more LEDs 1160 that may be configured to output information using one or more of a color, frequency, and duration of a display. In some examples, the disease management system 1103 may include other feedback mechanisms such as a buzzer 1176, a tactile actuator 1170, or a speaker for outputting information, such as an alarm, to the patient. In some examples, the disease management system 1103 may include a battery 1174 and a controller 1172. In some examples, the disease management system 1103 may include a drug administration system, such as a bladder 1180, a bladder pressure application device 1178 (e.g., a component of a pump) for applying pressure to the bladder, an actuator 1182, a pump gear 1184, and a pump 1186. In some examples, the disease management system 1103 may include one or more needles 1158 that may include one or more analyte sensors (e.g., glucose sensors) 1156. In some examples, the disease management system 1103 may include one or more needles 1162 that may include one or more cannulas 1164 configured to administer the drug to the patient. In some examples, the disease management system 1103 may include an air bubble sensor 1152 configured to detect the presence of air bubbles in the drug prior to delivery to the patient. In some examples, the glucose control system 1103 may include one or more physiological sensors 1154, such as non-invasive physiological sensors, including but not limited to a pulse sensor. In some examples, the disease management system 1103 can include a base plate 1106 and an adhesive layer 1168 beneath the base plate 1106 to provide for adhesion of the disease management system 1103 to the patient's skin.As described below, the housing of the disease management system 1103 may be comprised of a combination of flexible and rigid materials, both to provide support for the components of the disease management system 1103 and, at least in part, to conform the disease management system 1103 to the patient's skin.

[0095] The adhesive layer 1168 may be configured to provide adhesion over an extended period of time. For example, the adhesive layer 1168 may be configured to adhere the disease management system 1103 to the patient's skin for one day, three days, six days, more days, fewer days, longer times, or shorter periods of time. In some examples, the adhesive layer may be configured to have sufficient adhesion to prevent accidental removal or movement of the disease management system 1103 during the period of intended use of the disease management system 1103. In some examples, the adhesive layer 1168 may be a single layer of adhesive across at least a portion of the surface of the disease management system 1103 configured to interface with the patient. In some examples, the adhesive layer 1168 may include multiple adhesive regions on the surface of the disease management system 1103 configured to interface with the patient. In some examples, the adhesive layer 1168 may be configured to breathably adhere to the patient's skin after being wetted by moisture or liquids such as tap water, salt water, and chlorinated water. The thickness of the adhesive can be, for example, in the range of 0.1 to 0.5 mm, or a range of greater or lesser thicknesses.

[0096] In some examples, the needles 1158, 1162 may be inserted to different depths based on the patient's age, weight, or other parameters. For example, the depth of insertion of the drug cannula may be approximately 3 mm for ages 7 to 12. In other examples, the depth of insertion of the drug cannula may be approximately 4 mm for ages 13 and older. For example, the depth of insertion of the drug needle may be approximately 4 mm to 4.5 mm for ages 7 to 12. In other examples, the depth of insertion of the drug needle may be approximately 5 mm to 5.5 mm for ages 13 and older. In other examples, the depth of insertion of the analyte sensor may be approximately 3 mm for ages 7 to 12. In other examples, the depth of insertion of the analyte sensor may be approximately 4 mm for ages 13 and older. In other examples, the depth of insertion for the needle associated with the analyte sensor may be approximately 4 mm to 4.5 mm for ages 7 to 12. In another example, the insertion depth for a needle associated with an analyte sensor may be approximately 5 mm to 5.5 mm for ages 13 and older, however, other values ​​or ranges for any of the inserted components are possible.

[0097] B. Exemplary Muscle Wire Pump Figure 3 shows an embodiment of an example occluder style pump using muscle wire. Muscle wire pumps use muscle wire to apply force to a tubing or drug flow path as a result of at least the interaction between a spring and the muscle wire.

[0098] FIG. 3 shows a first configuration of a muscle wire pump utilizing rollers. In the illustrated example, the muscle wire 4628 may be wrapped around or in contact with one or more rollers 4625 that bear against a spacer 4627 in a central cam 4634. The spacer 4627 and central cam 4634 may be located on the upper side of the pump assembly. However, other configurations are possible. Additionally or alternatively, the muscle wire 4628 may be wrapped around one or more rollers 4621 that are configured to rotate around at least one pin 4629 located on the side of the pump assembly. However, other configurations are possible. The muscle wire 4624 may be coupled to one or more occluders 4630, also referred to herein as plungers. The muscle wire 4624 may be configured to receive electrical current through wire terminals 4623. When powered, the muscle wire 4624 may contract and move with the rollers, tilting the plunger 4630. When no power is applied, the muscle wire 4624 relaxes, allowing the spring 4632 to push the plunger down into the tubing (not shown). By changing the power to the muscle wire 4624, the plunger 4630 squeezes the tubing, causing it to perform a pumping action and facilitating the transfer of drug from the pouch to the cannula.

[0099] Components of a muscle wire pump system such as that shown in FIG. 3 may be replaced or simplified, for example, to reduce pump complexity, improve assembly, reduce response time, improve pump speed, and make pump function less dependent on the elastic modulus (or Young's modulus) of the tubing to achieve desired performance. For example, as shown in FIG. 4, one or more helical springs may be replaced with a disk spring 404. Additionally or alternatively, the contour and design of one or more plungers 406 may be simplified. Additionally or alternatively, the orientation of the tubing relative to one or more plungers may be changed. For example, the orientation of the tubing relative to the plunger may be configured such that the plunger requires less pressure to compress the tubing or otherwise block drug flow in the tubing.

[0100] As shown in FIG. 4, the muscle wire pump spring may include a disc spring 404. In some examples, the disc spring 404 may include silicone or other polymers, such as thermoplastic elastomers (TPEs), thermoplastic polyurethanes (TPUs), etc. Other materials may be used that can provide sufficient restoring force in response to displacement of at least a portion of the disc spring to move the muscle wire plunger. In some examples, the disc spring may include at least a portion configured to be displaced, such as having an approximately frustoconical shape. In some examples, the disc spring may be approximately flat when not displaced. In some examples, the disc spring may be approximately frustoconical when displaced. Other shapes of disc springs may be possible. For example, the disc spring may have an approximately circular profile from top to bottom with a curved side profile. In some examples, the curved side profile may include an S-shaped curvature. However, other curvatures of the curved side profile are possible.

[0101] The plunger 406 can be configured to compress a tube configured to carry the drug from the drug pouch to the patient. However, other configurations of the plunger and drug delivery or flow path are possible. For example, as shown in FIG. 4, the plunger 406 can be configured to occlude the flow path of the drug in the tube 408. In some examples, the plunger 406 can be configured to seal or occlude, or at least partially seal or occlude, a portion of the tube or flow path 408. In some examples, the plunger 406 can include a material such as silicone configured to form a seal when pressed into the flow path in the tube. The plunger 406 can be overmolded to secure or stabilize the plunger 406. For example, the overmolding can include silicone or a similar material. The plunger 406 can include a seal (e.g., an O-ring seal) to maximize the formation of a seal formed when pressed into the flow path. This can minimize the amount of fluid that can leak from the flow path. The shape of the plunger 406 can be any suitable shape to directly or indirectly occlude the flow path. For example, the plunger 406 may be configured to compress a tube or flow path, directly occlude a drug flow path, or the like. In some examples, the plunger's contact point, such as at least one surface of the plunger 406 configured to directly or indirectly engage a drug flow path, may be rectangular, square, circular, elliptical, oblong, asymmetric, or symmetric. The plunger 406 may be configured to be engaged by one or more springs 404 such that the one or more springs 404 can provide pressure to the plunger 406 to occlude or partially occlude the flow path. In some examples, the one or more springs 404 can apply a retraction pressure to the plunger 406 to block the flow path. In other words, the springs 404 can retract from the muscle wire to cause the plunger 406 to block the flow path.

[0102] As shown in FIGS. 5A and 5B, in some examples, the plunger 406 may be configured to be engaged by a lifting mechanism through a coupling 502, such as a crimp for the muscle wire configured to contract when an electric current is applied. The lifting mechanism may lift the plunger from the area of ​​the flow path to facilitate the flow of the drug from the drug pouch to the patient. In some examples, the plunger 406 may include or be coupled to a coupling 502, such as a crimp or engagement portion of the muscle wire. The muscle wire crimp 502 may be configured to grip the muscle wire or directly or indirectly couple the muscle wire to the plunger. Although a muscle wire is described herein as a lifting mechanism in many examples, other types of lifting mechanisms may additionally or alternatively be used.

[0103] As shown in Figures 5C and 5D, one or more components of the muscle wire pump may be overmolded and / or chemically bonded as part of the manufacturing process. For example, one or more springs 404, 506 may be bonded to a plate 508 to form an assembly 510 with the plunger 406, the plate being configured to include holes in the one or more plungers to move at least a portion of the plunger vertically relative to the horizontal plane of the plate 508. The one or more springs 506 may provide a retraction pressure to the plunger 406 to block the flow path. The spring 506 may include a membrane configured to encase the spring. For example, the membrane may include silicone or a similar material.

[0104] As shown in Figure 6, the assembly 510 can be configured to engage with a bottom portion 602 of a pump that includes a drug flow path. The assembly 510 can be configured to be welded (e.g., laser welded) to the bottom portion 602 or to be permanently or semi-permanently coupled to the bottom portion 602. As shown in Figure 6, the assembly can be incorporated into a larger assembly or can be configured to couple the pump assembly to a drug delivery device, such as the disease management device shown in Figures 1-2.

[0105] 7A-7C show example disc spring shapes and displacement and force simulations for the various disc spring shapes shown. In the examples shown in FIG. 7A and FIG. 7B, the disc spring comprises an approximately flat or frusto-conical shape. In some examples, the dimensions of the disc spring can correspond to the dimensions of the tube or diameter of the drug flow channel. In some examples, the dimensions of the disc spring can correspond to the shape of the plunger. The force limit for exertion on the disc spring can be calculated based on the pressure limit multiplied by the open area of ​​the disc spring. The open area is calculated as open area = π(D outer / 2) 2 D inner / 2 2 The pressure limit can be calculated as 300 / 760atm or (4x10 4 )(N / m 2 ) can be done.

[0106] For an example disc spring with an inner diameter of about 0.0 mm, the outer diameter is about 0.8 mm. The force limit may be calculated as 0.002 kgf. The safe force limit may be some percentage less than the overall force limit. For example, in the same example, the safe force limit may be 10 gf.

[0107] 7A shows diagrams 706A, 706B illustrating example stresses at the surface of a disc spring during a displacement of about 0.2 mm of an internal point 702 of the disc spring relative to an external point 704. As shown, the stress is greater in the displaced portion of the disc spring, increasing by approximately 2×10 6 )(N / m 2 ) or more.

[0108] FIG. 7B shows diagrams 708A, 708B illustrating example stresses at the surface of a disc spring during a displacement of about 0.5 mm of an internal point 702 of the disc spring relative to an external point 704. As shown, the stress is greater in the displaced portion of the disc spring, increasing by (8×10 6 )(N / m 2) or more.

[0109] 7C shows diagrams 710A, 710B, 710C illustrating example stresses on the surface of a disc spring having an S-shaped curvature between an internal point 702 and an external point 704. Diagram 710A shows the stresses during a displacement of about 0.12 mm of the internal point 702 of the disc spring relative to the external point 704. As shown, the stresses are greater in the displaced portion of the disc spring, increasing by (2x10 6 )(N / m 2 ) or more. Diagram 710B shows the stress during a displacement of about 0.35 mm of an interior point 702 of the disk spring relative to an exterior point 704. As shown, the stress is greater in the displaced portion of the disk spring, reaching a magnitude of (7x10 6 )(N / m 2 ) or more.

[0110] 8 illustrates example functionality of an example muscle wire pump 802. In the illustrated example, the muscle wire pump 802 can include a plurality of muscle wires or muscle springs 804, one or more guides 806 for the muscle wires 804, one or more plungers (also referred to herein as pistons) 808, and one or more flow channels 810. More, fewer, and / or different components may be used.

[0111] The pump may include a muscle wire 804 for each plunger 808. The muscle wire 804 may include any material configured to contract when an electric current is applied. For example, the muscle wire 804 may include Nitinol or a nickel-titanium alloy. Other shape memory alloys may also be used. In some examples, the muscle wire 804 may be suspended to maintain tension. In some examples, a guide 806 may be used to help support the wire 804. In some examples, a coupling component 810 may be configured to hold the guide 806, muscle wire 804, or other components in place relative to the pump or a disease management system to which the pump is coupled. Additionally or alternatively, the coupling component 810 may help guide or couple the muscle wire 804 towards or to electronic components of the pump configured to apply an electric current to the muscle wire. The muscle wire 804 may be configured to connect to a plunger 808. The plunger 808 may be configured to directly or indirectly occlude a drug flow path 810. The assembly may include multiple plungers 808 and muscle wires 804. A spring 812 may be coupled to each plunger 808 for applying a force to the plunger 808 to occlude the flow path.

[0112] The controller may be configured to control the operation of the pump by operating multiple plungers in sequence. FIG. 9 shows an example flow path 906 from an inlet 902, which may be associated with a fluid from a drug pouch to an outlet 904, which may be associated with a cannula configured to deliver the drug to a patient. The fluid and / or drug pouch may be under pressure. In some examples, the pressure applied to the fluid pouch may be minimal, but may be sufficient to push the fluid into or through the flow path. As the fluid leaves the fluid pouch, the pouch may collapse and continue to apply pressure to the fluid. Alternatively, the drug pouch need not be under pressure, in which case the plunger is configured to generate a negative pressure to pull the fluid into the flow path. A plunger, such as first plunger 908, may be configured to close or occlude the flow path 906 in a first configuration. To push the drug through the inlet 902 to the outlet 904, the controller can open or lift the plunger 908 so that the drug flows between the first and second plungers in the region 910A of the flow path. The first and second plungers can be lifted at about the same time or at the same time. Lifting the first and second plungers at the same time can create a vacuum that causes the drug to flow into the empty cavity. This can cause the drug to flow into the region 910A. The drug can flow into the flow path by either a positive pressure applied at the drug pouch or a negative pressure created by the retraction of each plunger. The controller can close or lower the first plunger to close or occlude the flow path. The second plunger can then be closed or occlude the flow path at approximately the same time or at the same time that the third plunger is lifted. This can minimize the amount of fluid that can flow back from the patient due to the vacuum created, and also creates a positive pressure on the drug in the flow path when the second plunger is released and pushes down on the drug. This can also force the drug to flow out of the region 910B between the second plunger and towards the outlet 904.In some examples, the closing of the second plunger may be delayed slightly relative to the contraction of the third plunger. This delay may be accounted for in timing such that the second plunger may be released before the third plunger is lifted so that both plungers move at or near the same time. This may be due to an increase in temperature of the muscle wire connected to the second plunger. In some examples, the controller may open and close the first and second plungers approximately at the same time, and open the second plunger when the first and third plungers are closed. When performing this sequence, the drug may be delivered from the inlet 902 to the outlet 904.

[0113] C. Exemplary Feedback Mechanisms In some examples, the pump system may include a feedback control system. FIGS. 10-12 show example aspects of feedback control for an example pump system. As shown in FIG. 10, the feedback mechanism may include, but is not limited to, an upper feedback PCB 1006, a lower feedback PCB 1010, one or more contact rings 1002 (mounted to an occlusion or plunger 1018), and one or more spacers 1008 for mounting the PCBs. During assembly, the lower feedback PCB 1010 may be mounted to the main housing 1020 first. Then, other components may be assembled layer by layer on top of the lower feedback PCB 1010. One or more components of the feedback system may be held in place and aligned using one or more components, such as alignment pins 1014 and one or more cleat 1016. For example, the upper PCB 1006 and the lower PCB may be aligned and held in place using alignment pins 1014 and one or more cleat 1016. The pump housing 1020 may be made of plastic, such as COC or PP material. The housing may be made of, but is not limited to, SiO 2It can also be made of other plastic polymers, including HDPE with a coating. The contact ring 1002 can be made of a highly conductive material. The contact ring 1002 can be coated with a carbon filled polymer or conductive silicone. The pattern and / or layout of the feedback PCB can play an important role. The pattern can significantly enhance the detection when the contact ring shorts the circuit. An example pattern 1012 is shown in FIG. 10.

[0114] The pump may include feedback notification to the controller when the plunger advances a desired distance to avoid damaging the shape memory alloy (such as a disc spring) by overstretching it. Feedback may also provide better control of bolus delivery by tightly controlling the distance the plunger advances. The feedback control signal may additionally or alternatively indicate when the plunger is fully seated thereby blocking fluid flow. The feedback control signal may additionally or alternatively indicate when the plunger is fully open thereby allowing fluid flow. Feedback control may be based on a short circuit created by the plunger between two traces in the printed circuit boards 1006, 1010 positioned above or below the plunger. The printed circuit boards may include one or more contact rings 1002 configured to detect contact by the plunger. One or more spacers 1008 between the circuit boards may prevent accidental or unintentional short circuits. The controller may read the feedback control signal and disable the plunger from moving further when it detects a short circuit.

[0115] When the top feedback PCB 1006 detects that the plunger 1018 moves to the up position, the plunger can be held in place. Pulse width modulation (PWM) can be activated, which maintains the temperature in the muscle wire. Thus, the muscle wire can remain immobile and hold the plunger immobile. Thus, the muscle wire can be tension-free with no additional tension or slack in tension. Additionally or alternatively, when the top feedback PCB 1006 detects that the plunger 1018 moves to the up position, it will reduce the power to the muscle wire. The top feedback can increase the power again when it detects that the plunger is disengaged. This cycling of power back and forth will cause the plunger to stay near the up position. When the bottom feedback PCB detects that the plunger touches the bottom, the system knows the plunger is fully closed. This can ensure that the plunger is fully closed.

[0116] FIG. 11 illustrates an example of a muscle wire pump 1100 that includes a feedback mechanism 1102. The feedback mechanism 1102 can operate in combination with other components of the muscle wire pump to maximize the control, precision, accuracy, etc. of the muscle wire pump. For example, the muscle wire pump 1100 can include multiple electrical connectors 1104, multiple muscle wires 1106, and multiple conductive wires 1108 configured to connect to the muscle wires. The electrical connectors 1104 and conductive wires 1108 can be used to facilitate or allow signals to be sent to the lifting mechanism or the muscle wires 1106. As previously described, the muscle wire pump can include multiple plungers 1110, a pump lid 1112, a pump housing 1114, a pump outlet 1116, and a pump inlet 1118. The muscle wire pump 1100 can further include at least one feedback ring 1120 that can enable the feedback mechanism 1102 to monitor the position and status of each plunger 1110. In some examples, there may be a feedback ring connected to each plunger in the muscle wire pump. For example, the feedback ring 1120 may have a signal to the feedback mechanism that facilitates monitoring or controlling the status of each of the plungers 1110. In some examples, when the plungers are in an open position, the feedback ring may contact a feedback mechanism that may activate a signal that is sent to the feedback mechanism. The signal may inform the feedback mechanism that the plungers are in an open position. In some examples, when the plungers are in a closed position, the feedback ring may contact a feedback mechanism that may activate a signal that is sent to the feedback mechanism. The signal may inform the feedback mechanism that the plungers are in a closed position. In some examples, when the feedback ring is not in contact with the feedback mechanism, the feedback mechanism may not monitor the position and status of the plungers. The muscle wire pump 1100 may include a cable (e.g., a flex cable) configured to connect to the feedback mechanism 1102.

[0117] FIG. 12 shows a cross-sectional view of FIG. 11, where each of the component integrations, connections, and / or couplings of the muscle wire pump may be important for the feedback mechanism. As shown in FIG. 12, the muscle wire pump 1100 may include a feedback ring 1120 connected to each one of the multiple plungers 1110, a PCB 1203, a crimp connector 1204, at least one conductive wire 1108, a seal 1206, at least one muscle wire 1106, an inlet 1118, an adapter 1212 configured to connect to the plunger 1210, and a spacer 1214. The feedback ring 1120 may be configured to directly contact the PCB 1203. The crimp connector 1204 may be configured to couple each of the conductive wires to each of the muscle wires for each of the multiple plungers in the muscle wire pump. This contact may thus activate a feedback mechanism to monitor or control the position and status of the plunger 1110. Direct contact between the feedback ring 1120 and the PCB 1203 can be useful in allowing the feedback mechanism to have a signal that facilitates monitoring or controlling the status of the plunger 1110. For example, the signal can allow the feedback mechanism to determine the position of the plunger. In some examples, the signal can allow the feedback mechanism to determine whether the plunger is in an open or closed position. The feedback ring 1120 can maximize the control, precision, accuracy, etc. of the muscle wire pump. In some examples, the conductive wire 1108 (e.g., copper wire) can be connected to both the muscle wire 1106 and the feedback ring 1120, as the conductive wire 1108 (e.g., copper wire) carries the electrical connection to the muscle wire pump, including the crimp connector 1204. This connection can allow the feedback mechanism to monitor the position and / or status of the plunger when the feedback ring 1120 contacts the PCB 1203 to activate a signal. Specifically, as shown in FIG. 12, the conductive wire 1108 can exit the internal compartment of each of the multiple plungers at an exit location where a feedback ring 1120 is connected to each of the multiple plungers 1110.This allows the conductive wire 1108 to connect to both the muscle wire 1106 and the feedback ring 1120.

[0118] A feedback mechanism informs the controller of the position of the plunger. A feedback signal may be used to inform the controller whether the plunger is in an open or closed position. In some examples, a feedback signal may be used to inform the controller whether the plunger is partially open or fully open. For example, the controller may open the plunger at 25%, 50%, 75%, or 100% open positions. Additionally, the degree to which the plunger is open may control the bolus amount or volume of fluid pumped through the pump system. Similarly, the degree to which the plunger is open may determine the volume of fluid and therefore the rate at which fluid flows through the pump system. Advantageously, this may conserve power in cases where at least some of the plungers do not need to be fully opened to deliver a sufficient bolus. This may vary based on the rate at which a patient-specific bolus amount may be required to be pumped through the pump system. Additionally or alternatively, shutting off power to at least some of the plungers may increase the accuracy of the muscle wire pump system. The plungers may be specifically timed so that fluid can move in one direction to the other, such as from a drug bladder or pouch to a catheter or cannula implanted in the patient. In some examples, the timing of the plungers may be used to determine the position of each of multiple plungers. The plungers may each be in an open position at the same time, which may allow for unregulated flow of fluid from the pouch. The pouch may be pressurized or under pressure. Pressure from the pouch allows the drug to flow past the plunger when it is in the open position. This may be advantageous in ensuring that the drug is delivered to the patient when it is needed, since the drug can only be released when the plunger opens to the extent of the open position. Additionally or alternatively, a feedback mechanism may be used so that precise timing of the plunger action may be implemented. For example, a signal may activate the feedback mechanism when the plunger reaches the open position.In some examples, when the plunger reaches the open position, a signal may activate a feedback mechanism. In this manner, the amount of drug delivered to the patient can be controlled, since due to the staggered timing of the plunger opening, only a small portion of the drug is released at any given time.

[0119] The controlled amount of drug delivered to the patient can be accurate and precise to the required dose of drug. Advantageously, the placement, timing, or degree of plunger opening can be finely adjusted, which allows for a controlled and / or precise amount of drug delivered to the patient. For example, when the plunger is in a 100% open position, the maximum amount of drug can enter the muscle wire pump. Similarly, when the plunger is in a position that is less than 100%, an amount of drug equal to the percentage of the plunger's open position will be delivered to the patient. A feedback mechanism can send a signal to accurately inform the patient that the correct amount of drug or fluid can be delivered to the patient based on the signal formed when each of the plungers reaches the open or closed position. Additionally or alternatively, the feedback mechanism can ensure that the drug is not dissipating through the muscle wire pump system.

[0120] Advantageously, the feedback mechanism may also provide a safety factor for the muscle wire pump system. For example, the feedback mechanism may know or register when the plunger is in an open position and / or when the plunger is in a closed position.

[0121] D. Terminology While the foregoing description has pointed out the novel features of the invention as applied in various embodiments, those skilled in the art will recognize that various omissions, substitutions, and changes in the form and details of the described devices or processes may be made without departing from the scope of the invention. The scope of the invention is therefore defined by the appended claims, rather than by the foregoing description. All variations that come within the meaning and range of equivalency of the claims are embraced within their scope.

[0122] References throughout this specification to "some embodiments" or "embodiments" mean that the specific features, structures, or characteristics described in connection with the embodiments are included in at least some of the embodiments. Thus, the appearances of the phrase "in some embodiments" or "in an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiments, but may refer to one or more of the same or different embodiments. Furthermore, the specific features, structures, or characteristics may be combined in any suitable manner in one or more embodiments, as would be apparent to one of ordinary skill in the art from this disclosure.

[0123] As used in this application, terms such as "comprising," "including," and "having" are synonymous and are used inclusively in an open-ended manner and do not exclude additional elements, features, acts, operations, etc. Also, the term "or," when used, for example, to connect a list of elements, is used in its inclusive sense (and not in its exclusive position) to mean one, some, or all of the elements in the list.

[0124] Similarly, in the foregoing description of the embodiments, it should be understood that various features may be grouped together in a single embodiment, figure, or description thereof for purposes of streamlining the disclosure and aiding in understanding one or more of the various inventive embodiments. However, this method of disclosure is not to be interpreted as reflecting an intention that any claim requires more features than are expressly recited in that claim. Rather, inventive embodiments lie in a combination of fewer than all features of any single foregoing disclosed embodiment.

[0125] Aspects of the disclosed systems and methods may be used and / or implemented with local and / or remote devices, components, and / or modules. The term "remote" may include devices, components, and / or modules that are not stored locally, e.g., not accessible via a local bus. Thus, remote devices may include devices that are physically located in the same room and connected via devices such as switches or local area networks. In other situations, remote devices may be located geographically apart, such as in different locations, buildings, towns, and countries.

[0126] Although described in the illustrative context of certain preferred embodiments and examples, it will be appreciated by those skilled in the art that the disclosure extends beyond the explicitly described embodiments to other alternative embodiments and / or uses, as well as obvious modifications and equivalents, and it is therefore intended that the following claims not be limited by the specific embodiments described above. [Explanation of symbols]

[0127] 404 Disc Spring 406 Plunger 408 Pipes, Channels 502 Coupling, Muscle Wire Crimp 506 Spring 602 Bottom part 702 Internal points 704 External points 706A, 706B, 708A, 708B, 710A, 710B, 710C diagram 802 Muscle Wire Pump 804 Muscle wire, muscle spring 806 Information Department 808 Plunger, piston 810 Flow path, connecting components 902 Entrance 904 Exit 906 Flow Path 908 First Plunger 1002 Contact Ring 1006 Top Feedback PCB 1008 Spacer 1010 Bottom Feedback PCB 1012 Patterns 1014 Alignment pin 1016 Stopper 1018 Obstruction, plunger 1020 Main housing, pump housing 1100 Muscle Wire Pump 1101 Disease Management System 1102 Feedback mechanism 1103 Disease management systems, glucose control systems 1104 Electrical connectors 1106 Foundation plate 1106 Muscle Wire 1108 Conductive Wire 1110 Plunger 1112 Pump cover 1114 Pump housing 1116 Pump outlet 1118 Pump inlet 1120 Analyte sensor, feedback ring 1122 Drug catheters, insulin catheters 1124 Physiological Sensors 1126 Analyte detector 1128 Drug Bladder 1130 Pump 1134 Physiological Detectors 1136 Local User Interface Components 1138 Control device 1140 Communication components 1142 NFC Tag 1144 Power Components 1146 Connector Test Points 1152 Air Bubble Sensor 1154 Physiological Sensors 1156 Analyte Sensors 1158 needle 1160 LED 1162 needle 1164 Cannula 1168 Adhesive layer 1170 Haptic Actuator 1172 Control device 1174 battery 1176 Buzzer 1178 Bladder pressure application device 1180 Vlada 1182 Actuator 1184 Pump Gear 1186 Pump 1190 Applicator 1192 Safety Button 1203 PCB 1204 Crimp Connector 1206 Seal 1210 Plunger 1212 Adapter 1214 Spacer 4623 Wire Terminal 4624 Muscle Wire 4625 Lola 4627 Spacer 4628 Muscle Wire 4629 Pins 4630 Obstruction, plunger 4632 Spring 4634 Center Cam

Claims

1. 1. A drug delivery pump configured to deliver a drug from a drug pouch to a patient, comprising: at least two plungers configured to deliver the medication from the medication container to the cannula; at least two wires, each operatively connected to a respective one of the at least two plungers, wherein when one of the at least two wires is actuated, at least one of the at least two plungers is configured to create a negative pressure to draw a drug into the drug flow path; two or more disc springs configured to provide a retraction pressure to at least one of the two or more plungers, wherein when the connected wire is not actuated, the at least two plungers are repositioned to apply a positive pressure to the medicament; and A disease management device comprising a drug delivery pump comprising:

2. 10. The disease management device of claim 1, wherein the one or more wires are one or more muscle wires that expand or contract when electricity is applied to them.

3. The disease management device of claim 1 , further comprising an analyte sensor.

4. The disease management device of claim 1 , wherein the medication comprises at least one of insulin or glucagon.

5. The disease management device of claim 1 , wherein the one or more springs comprise silicon.

6. The disease management device of claim 2 , wherein the two or more muscle wires comprise nitinol wires.

7. 7. The disease management device of claim 6, wherein the two or more muscle wires comprise a nickel-titanium alloy.

8. 10. The disease management device of claim 1, wherein the at least two plungers comprise first, second, and third plungers configured to block the flow path of the medication at first, second, and third locations of the flow path, respectively.

9. 10. The disease management device of claim 1, further comprising one or more hardware processing units configured to actuate and engage at least one of the at least two or more plungers in a pattern with at least two or more of the wires to move a drug from the drug pouch into the cannula.

10. 1. A method for delivering a liquid medication from a medication pouch to a patient, comprising: retracting one or more plungers from a non-retracted position to create a negative pressure to draw the drug into the drug flow path; using one or more disc springs of the one or more plungers to retract the one or more plungers to the unretracted position and apply positive pressure to the drug flow path; A method comprising:

11. 11. The method of claim 10, further comprising sensing one or more physiological parameters of the patient with an analyte sensor.

12. 11. The method of claim 10, wherein the liquid medication comprises at least one of insulin or glucagon.

13. The method of claim 10 , wherein the one or more springs comprise silicon.

14. The method of claim 10 , wherein the step of retracting the one or more plungers comprises using muscle wire to retract the one or more plungers.

15. 15. The method of claim 14, wherein the one or more muscle wires comprise nitinol wire.

16. The method of claim 10 , wherein the one or more plungers include a first, second, and third plunger.

17. 17. The method of claim 16, further comprising one or more hardware processing devices that engage the first, second, and third plungers in a pattern with one or more muscle wires to cause the liquid drug to flow from the drug pouch to the patient.

18. applying electrical signals to the first wire and the second wire to cause the first plunger to create a negative pressure via the first wire, causing drug to flow into the flow path in a first portion, and the second plunger to create a negative pressure via the second wire in a second portion; ceasing application of the electrical signal to the first wire so that a first disc spring applies a retraction pressure to the first plunger, thereby retracting the first plunger to a non-retracted position and applying positive pressure to the drug in the first portion of the flow path; applying a second electrical signal to a third wire to cause the third plunger to create a negative pressure in a third portion and ceasing application of the electrical signal to the second wire to allow a second spring to apply a retraction pressure to the second plunger, thereby retracting the second plunger to a non-retracted position and applying a positive pressure to the drug in the second portion of the flow path; 20. The method of claim 17, further comprising:

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