Infusion pump methods, systems, and devices

Abstract

A system for priming an infusion pump is disclosed.SOLUTION: The system includes a priming cap including a septum and configured to mateably connect with a male component 2106 comprising a needle 2104 and attached to a length of tubing 2100 for fluid, wherein when mateably connected with the male component, the priming cap occludes the tubing. In accordance with one aspect of the present invention, a method for priming an infusion pump assembly is disclosed. The method includes connecting a male part comprising a needle attached to a length of tubing to a priming cap comprising a septum, instructing an infusion pump to prime, and priming the infusion pump into the priming cap.SELECTED DRAWING: Figure 21

Description

[Technical Field]

[0001] (Technical field) The present disclosure relates to pump assemblies, and more particularly to infusion pump assemblies, methods, systems, and devices. [Background technology]

[0002] An infusion pump assembly can be used to infuse fluids (e.g., medications or nutrients) into a user. Fluids may be infused intravenously (i.e., into a vein), subcutaneously (i.e., into the skin), intra-arterially (i.e., into an artery), and epidurally (i.e., into the epidural space).

[0003] Infusion pump assemblies may administer fluids in a manner that is impractically expensive and / or unreliable if performed manually by nursing personnel. For example, an infusion pump assembly may repeatedly administer small amounts of infusible fluid (e.g., 0.1 mL every hour) while allowing the user to request a one-time, larger "bolus" dose. Summary of the Invention [Means for solving the problem]

[0004] According to one aspect of the present invention, a system for priming an infusion pump is disclosed. The system includes a priming cap including a septum, equipped with a needle, and configured for mating connection with a male fitting attached to a length of fluid tubing, the priming cap occluding the tubing when matingly connected to the male fitting. Some embodiments of this aspect of the invention may include a reservoir, the tubing being removably connected to the reservoir, and fluid from the reservoir being in fluid communication with the tubing.

[0005] According to one aspect of the present invention, a method for priming an infusion pump assembly is disclosed, the method including the steps of connecting a male component having a needle attached to a length of tubing to a priming cap having a septum, commanding the infusion pump to prime, and priming the infusion pump into the priming cap.

[0006] According to one aspect of the present invention, a method for performing an occlusion alarm check is disclosed, the method including the steps of connecting a male part having a needle attached to a length of tubing to a priming cap having a septum, commanding an infusion pump to prime, and causing the infusion pump to prime into the priming cap.

[0007] According to one aspect of the present invention, a method for performing an occlusion alarm check is disclosed, the method including the steps of connecting a male member having a needle attached to a length of tubing to a priming cap having a septum, commanding an infusion pump to prime, priming the infusion pump into the priming cap for a predetermined amount of time, removing the male member from the priming cap once an occlusion alarm occurs, and determining a failed occlusion alarm if an occlusion alarm does not occur after the predetermined amount of time.

[0008] In accordance with one aspect of the present invention, a system for determining connection to a cannula is disclosed, the system including a male component connected to a length of tubing, a female component fluidly connected to the cannula, and electrical contacts on the male and female components, the electrical contacts completing a circuit when the male component is connected to the female component.

[0009] Some embodiments of this aspect of the invention may include one or more of the following features: The length of tubing further includes one or more wires in electrical communication with the circuitry and with the infusion pump, whereby electrical signals are sent to the infusion pump using the wires; The infusion pump further includes a pump processor, whereby the pump processor receives the electrical signals; The system further includes a reservoir in fluid communication with the length of tubing.

[0010] According to one aspect of the present invention, a system for determining connection to a cannula is disclosed, the system including a male component connected to a length of tubing, a female component fluidly connected to the cannula, an RFID chip located on the male component, and an antenna located on the female component in communication with the RFID chip, the antenna wirelessly communicating with a medical device to indicate whether the male and female components are connected.

[0011] In accordance with one aspect of the present invention, a system for priming an infusion pump is disclosed that includes a male component connected to a length of tubing, a female component fluidly connected to a cannula, an RFID chip located on the male component, an antenna located on the female component in communication with the RFID chip, the antenna wirelessly communicating with the infusion pump to indicate whether the male and female components are connected, and a pump processor configured to alert the infusion pump when a command to prime is received and the male and female components are connected.

[0012] According to one aspect of the present invention, a method for preventing priming when a user is connected to an infusion pump is disclosed, the method including the steps of: a pump processor receiving a command to prime; the pump processor determining whether the male and female components are connected; alerting the user and preventing priming if the male and female components are connected; and allowing priming if the male and female components are not connected.

[0013] Some embodiments of this aspect of the invention may include one or more of the following features: The alarm is a visual alarm; The alarm is an audio alarm; The alarm is a vibration alarm; The alarm is transmitted to a remote control.

[0014] According to one aspect of the present invention, a system for loading a reservoir into an infusion pump is disclosed, the system including a reservoir housing adapted to receive the reservoir, a motor connection connected to the motor, a pusher driven by the motor connection, and a plunger contact connected to the plunger in the reservoir, the pusher driving the plunger when the pusher and plunger contact are connected, and the system determines when the pusher and plunger contact are connected by an optical sensor.

[0015] In accordance with one aspect of the present invention, a removable power supply cover assembly for an infusion pump is disclosed. The assembly includes a housing body configured to removably attach to the infusion pump, a conductor assembly attached to the housing body, a power supply contact assembly, and a spring attached to the power supply contact assembly and the conductor assembly. An electrical connection between the power supply and the conductor assembly is formed via the spring.

[0016] Some embodiments of this aspect of the invention may include one or more of the following features: The removable power supply assembly includes a battery. The body of the housing further includes a sealing assembly for releasably engaging at least a portion of the enclosure assembly and forming an essentially watertight seal between the removable cover assembly and the enclosure assembly. The sealing assembly includes an O-ring assembly. The body of the housing is configured to provide access to the power supply cavity and to effect removable insertion of the removable power supply assembly into the power supply cavity.

[0017] According to another aspect of the present invention, an infusion pump assembly is disclosed that includes an enclosure assembly, a pump assembly configured to be at least partially disposed within the enclosure assembly and to effectuate dispensing of an infusible fluid contained in a reservoir assembly, and a removable cover assembly configured to releasably engage the enclosure assembly, the removable cover assembly including a body of the housing, a conductor assembly attached to the body of the housing, a power supply contact assembly, and a spring attached to the power supply contact assembly and the conductor assembly, wherein an electrical connection between the power supply and the conductor assembly is formed through the spring.

[0018] Some embodiments of this aspect of the invention may include one or more of the following features: The reservoir assembly is at least partially disposed within the enclosure assembly and configured to contain an infusible fluid. The infusion pump further includes processing logic disposed at least partially within the enclosure assembly and configured to control the pump assembly. The removable power supply assembly includes a battery. The removable cover assembly includes a sealing assembly for releasably engaging at least a portion of the enclosure assembly and forming an essentially watertight seal between the removable cover assembly and the enclosure assembly. The sealing assembly includes an O-ring assembly. The removable cover assembly is configured to provide access to the power supply cavity and to effectuate removable insertion of the removable power supply assembly into the power supply cavity.

[0019] According to another aspect of the present invention, a medical device assembly is disclosed. The assembly includes an enclosure assembly and a removable cover assembly configured to releasably engage the enclosure assembly. The combination of at least a portion of the removable cover assembly and the enclosure assembly defines a power supply cavity configured to prevent the removable power supply assembly from being electrically coupled to the processing logic in reverse polarity.

[0020] Some embodiments of this aspect of the invention may include one or more of the following features: the removable cover assembly is configured to provide access to the power supply cavity and effectuate removable insertion of the removable power supply assembly into the power supply cavity; the removable power supply assembly includes a battery; the removable cover assembly includes a sealing assembly for releasably engaging at least a portion of the enclosure assembly and forming an essentially watertight seal between the removable cover assembly and the enclosure assembly; the sealing assembly includes an O-ring assembly; and the removable cover assembly includes a conductor assembly configured to mechanically couple the removable cover assembly with an inner wall of the power supply cavity. The assembly further includes the removable cover assembly including a first twist lock assembly, and the enclosure assembly including a second twist lock assembly configured to releasably engage the first twist lock assembly and effectuate releasable engagement of the removable cover assembly and the enclosure assembly. The assembly further includes a reservoir assembly disposed at least partially within the enclosure assembly and configured to contain an infusible fluid, a pump assembly disposed at least partially within the enclosure assembly and configured to effectuate dispensing of the infusible fluid contained in the reservoir assembly, and processing logic disposed at least partially within the enclosure assembly and configured to control the pump assembly.

[0021] According to another aspect of the present invention, in a first implementation, an infusion pump assembly includes an enclosure assembly. A reservoir assembly is disposed at least partially within the enclosure assembly and configured to contain an infusible fluid. A pump assembly is disposed at least partially within the enclosure assembly and configured to effect dispensing of the infusible fluid contained within the reservoir assembly. Processing logic is disposed at least partially within the enclosure assembly and configured to control the pump assembly. The removable cover assembly is configured to releasably engage the enclosure assembly, and the combination of at least a portion of the removable cover assembly and the enclosure assembly defines a power supply cavity configured to prevent the removable power supply assembly from being electrically coupled to the processing logic in reverse polarity.

[0022] One or more of the following features may be included: The removable cover assembly may be configured to provide access to the power supply cavity and to effect removable insertion of a removable power supply assembly into the power supply cavity. The removable power supply assembly may include a battery.

[0023] The removable cover assembly may include a sealing assembly for releasably engaging at least a portion of the enclosure assembly and forming an essentially watertight seal between the removable cover assembly and the enclosure assembly. The sealing assembly may include an O-ring assembly. The removable cover assembly may include a conductor assembly configured to mechanically couple the removable cover assembly to an inner wall of the power supply cavity.

[0024] The removable cover assembly may include a first twist lock assembly, and the enclosure assembly may include a second twist lock assembly configured to releasably engage the first twist lock assembly to achieve releasable engagement between the removable cover assembly and the enclosure assembly.

[0025] In another implementation, an infusion pump assembly includes an enclosure assembly. A reservoir assembly is disposed at least partially within the enclosure assembly and configured to contain an infusible fluid. A pump assembly is disposed at least partially within the enclosure assembly and configured to effect dispensing of the infusible fluid contained within the reservoir assembly. Processing logic is disposed at least partially within the enclosure assembly and configured to control the pump assembly. A removable cover assembly is configured to releasably engage the enclosure assembly. The removable cover assembly includes a sealing assembly for releasably engaging at least a portion of the enclosure assembly and forming an essentially watertight seal between the removable cover assembly and the enclosure assembly. The combination of the removable cover assembly and at least a portion of the enclosure assembly defines a power supply cavity configured to allow removable insertion of a removable power supply assembly.

[0026] One or more of the following features may be included: The removable cover assembly may be configured to provide access to the power supply cavity and to effect removable insertion of a removable power supply assembly into the power supply cavity. The removable power supply assembly may include a battery. The sealing assembly may include an O-ring assembly.

[0027] The removable cover assembly may include a conductor assembly configured to mechanically couple the removable cover assembly to an inner wall of the power supply cavity. The removable cover assembly may include a first twist lock assembly. The enclosure assembly may include a second twist lock assembly configured to releasably engage the first twist lock assembly to achieve releasable engagement between the removable cover assembly and the enclosure assembly.

[0028] In another implementation, an infusion pump assembly includes an enclosure assembly. A reservoir assembly is at least partially disposed within the enclosure assembly and configured to contain an infusible fluid. A pump assembly is at least partially disposed within the enclosure assembly and configured to effect dispensing of the infusible fluid contained within the reservoir assembly. Processing logic is at least partially disposed within the enclosure assembly and configured to control the pump assembly. A removable cover assembly configured to releasably engage with the enclosure assembly includes a first twist lock assembly. The combination of at least a portion of the removable cover assembly and the enclosure assembly defines a power supply cavity configured to allow removable insertion of a removable power supply assembly. The enclosure assembly includes a second twist lock assembly configured to releasably engage with the first twist lock assembly to effect releasable engagement between the removable cover assembly and the enclosure assembly.

[0029] One or more of the following features may be included: The removable cover assembly may be configured to provide access to the power supply cavity and to effect removable insertion of the removable power supply assembly into the power supply cavity. The removable power supply assembly may include a battery. The removable cover assembly may include a conductor assembly configured to mechanically couple the removable cover assembly with an inner wall of the power supply cavity.

[0030] In another implementation, an infusion pump assembly includes an enclosure assembly. A reservoir assembly is disposed at least partially within the enclosure assembly and configured to contain an infusible fluid. A pump assembly is disposed at least partially within the enclosure assembly and configured to effectuate dispensing of the infusible fluid contained within the reservoir assembly. Processing logic is disposed at least partially within the enclosure assembly and configured to control the pump assembly. A removable cover assembly is configured to releasably engage the enclosure assembly. The combination of the removable cover assembly and at least a portion of the enclosure assembly defines a power supply cavity configured to allow removable insertion of a removable power supply assembly. The removable cover assembly includes a conductor assembly configured to mechanically couple the removable cover assembly to an inner wall of the power supply cavity.

[0031] One or more of the following features may be included: The removable cover assembly may be configured to provide access to the power supply cavity and to effect removable insertion of a removable power supply assembly into the power supply cavity. The removable power supply assembly may include a battery.

[0032] According to one aspect of the present invention, an infusion pump assembly is disclosed. The infusion pump assembly includes a locking tab and a pump barrel inside a pump barrel housing, the pump barrel housing containing a reservoir assembly. The reservoir assembly includes a reservoir and a plunger rod. The infusion pump assembly also includes a locking disk at a distal end of the pump barrel. The locking disk includes a clearance hole for the plunger rod. The locking disk also includes at least one locking tab notch in close proximity to the locking tab. The locking tab is movably engaged with the locking tab notch, and the reservoir moves the locking tab from a locked position to a released position when the plunger rod is inserted through the clearance hole. The locking disk rotates when torque is applied to the reservoir assembly, causing the locking disk to rotate relative to the plunger rod and drive screw from an unloaded position to a loaded position.

[0033] Some embodiments of this aspect of the invention may include one or more of the following features. The locking disk may further include a second locking tab notch, the second locking tab notch engaged with the locking tab when the locking disk is in the loaded position. The locking disk may further include a plunger rod support. The plunger rod support may be in close contact with the plunger rod support when the plunger rod is inserted through the clearance hole. The locking disk may further include at least two reservoir tab openings for mating with at least two reservoir alignment tabs on the reservoir. The reservoir assembly may further include a locking hub. The locking hub may be fluidly connected to the reservoir. The locking hub may further include at least two locking hub alignment tabs, the locking hub alignment tabs align with the reservoir alignment tabs when the locking hub is fluidly connected to the reservoir. The infusion pump assembly may further include a hub and a battery end cap. The end cap may have an opening to the pump barrel. The pump barrel opening may complement the locking hub alignment tab, and loading of the reservoir assembly may provide alignment of the reservoir alignment tab with the reservoir tab opening and alignment of the plunger rod with the clearance hole. The hub and battery end cap may further include a first alignment feature. The first alignment feature may complement a second alignment feature on the reservoir. When the first alignment feature and the second alignment feature are aligned, the locking hub alignment tab may also be aligned with the hub and battery cap opening.

[0034] According to one aspect of the present invention, a reservoir assembly is disclosed. The reservoir assembly includes a reservoir having an interior volume and terminating in a male feature on a first end. The reservoir assembly also includes a plunger rod having a threaded portion and a notched portion. The assembly further includes a reservoir bottom having a plunger rod opening and at least two reservoir alignment tabs, with the plunger rod extending through the plunger rod opening.

[0035] Some embodiments of this aspect of the invention may include one or more of the following features: The reservoir assembly may further include an alignment feature on the reservoir. The alignment feature may allow the reservoir assembly to be aligned with the infusion pump assembly for loading the reservoir assembly into the infusion pump assembly. A removable filling aid may be included having a threaded portion and a handle portion. The threaded portion may threadably engage with the threaded portion of the plunger rod.

[0036] According to one aspect of the present invention, a method of loading a reservoir assembly onto a drive mechanism of an infusion pump assembly is disclosed. The method includes aligning locking tab alignment features of the reservoir and locking tab assembly with alignment features on the hub and battery end cap of the infusion pump assembly and rotating the locking tab until the locking tab is flush with the infusion pump assembly. Rotating the locking tab loads the reservoir and locking hub assembly onto the drive mechanism of the infusion pump assembly.

[0037] According to another aspect of the invention, a method includes administering a sequential multi-part infusion event, the sequential multi-part infusion event including a plurality of discrete infusion events. If a single infusion event is available for administration, administration of at least a portion of the plurality of discrete infusion events included within the sequential multi-part infusion event is delayed. The single infusion event is administered.

[0038] One or more of the following features may be included: once administration of the single infusion event is complete, at least a portion of the multiple discrete infusion events contained within the sequential multi-part infusion event may be administered; the sequential multi-part infusion event may include a basal infusion event; the sequential multi-part infusion event may include an extended bolus infusion event; the single infusion event may include a regular bolus infusion event.

[0039] At least one of the plurality of discrete infusion events may include a plurality of discrete infusion sub-events. A single infusion event may include a plurality of single infusion sub-events.

[0040] In another implementation, a computer program product resides on a computer-readable medium having a plurality of instructions stored thereon. When executed by a processor, the instructions cause the processor to perform operations including administering a sequential, multi-part infusion event, the sequential, multi-part infusion event including a plurality of discrete infusion events. If a single infusion event is available for administration, administration of at least a portion of the plurality of discrete infusion events included within the sequential, multi-part infusion event is delayed. The single infusion event is administered.

[0041] One or more of the following features may be included: once administration of the single infusion event is complete, at least a portion of the multiple discrete infusion events contained within the sequential multi-part infusion event may be administered; the sequential multi-part infusion event may include a basal infusion event; the sequential multi-part infusion event may include an extended bolus infusion event; the single infusion event may include a regular bolus infusion event.

[0042] At least one of the plurality of discrete infusion events may include a plurality of discrete infusion sub-events. A single infusion event may include a plurality of single infusion sub-events.

[0043] In another implementation, the infusion pump assembly is configured to perform an operation that includes administering a sequential multi-part infusion event, the sequential multi-part infusion event including a plurality of discrete infusion events. If a single infusion event is available for administration, administration of at least a portion of the plurality of discrete infusion events included within the sequential multi-part infusion event is delayed. The single infusion event is administered.

[0044] One or more of the following features may be included: once administration of the single infusion event is complete, at least a portion of the multiple discrete infusion events comprised within the sequential multi-part infusion event may be administered; the sequential multi-part infusion event may include a basal infusion event; the sequential multi-part infusion event may include an extended bolus infusion event; the single infusion event may include a regular bolus infusion event.

[0045] At least one of the plurality of discrete infusion events may include a plurality of discrete infusion sub-events. A single infusion event may include a plurality of single infusion sub-events.

[0046] In a first implementation, the method includes determining a first rate-of-change of force readings corresponding to delivery of a first dose of infusible fluid via the infusion pump assembly, determining at least a second rate-of-change of force readings corresponding to delivery of at least a second dose of infusible fluid via the infusion pump assembly, and determining an average rate-of-change of force readings based at least in part on the first rate-of-change of force readings and the at least second rate-of-change of force readings.

[0047] One or more of the following features may be included: The average rate-of-change of force reading may be compared to a threshold rate-of-change of force reading to determine whether the average rate-of-change of force reading exceeds the threshold rate-of-change of force reading; If the average rate-of-change of force reading exceeds the threshold rate-of-change of force reading, an alarm sequence may be initiated on the infusion pump assembly.

[0048] Determining the first rate-of-change of force readings may include determining a first initial force reading before dispensing the first dose of infusible fluid. The first dose of infusible fluid may be dispensed. The first final force reading may be determined after dispensing the first dose of infusible fluid. The first rate-of-change of force readings may be determined based at least in part on the first initial force reading and the first final force reading.

[0049] One or more of the first initial force measurement and the first final force measurement may be compared to determine whether one or more of the first initial force measurement and the first final force measurement exceed a threshold force measurement, and if one or more of the first initial force measurement and the first final force measurement exceed a threshold force measurement, an alarm sequence may be initiated on the infusion pump assembly.

[0050] Determining the at least second rate-of-change of force readings may include determining at least a second initial force reading before dispensing at least a second dose of infusible fluid. The at least a second dose of infusible fluid may be dispensed. The at least a second final force reading may be determined after dispensing at least a second dose of infusible fluid. The at least a second rate-of-change of force readings may be determined, at least in part, based on the at least a second initial force reading and the at least a second final force reading.

[0051] The infusion pump assembly may include a battery assembly configured to power the infusion pump assembly. An actual voltage level of the battery assembly may be compared to a minimum voltage requirement to determine whether the actual voltage level meets the minimum voltage requirement. If the actual voltage level does not meet the minimum voltage requirement, an alarm sequence may be initiated on the infusion pump assembly.

[0052] One or more displaceable mechanical components included within the infusion pump assembly may be monitored to determine whether the one or more displaceable mechanical components have been displaced an expected displacement in response to the delivery of one or more of the first dose and the second dose of infusible fluid, and an alarm sequence may be initiated on the infusion pump assembly if the one or more displaceable mechanical components have not been displaced an expected displacement in response to the delivery of one or more of the first dose and the second dose of infusible fluid.

[0053] In another implementation, a computer program product resides on a computer-readable medium having a plurality of instructions stored thereon. When executed by a processor, the instructions cause the processor to perform operations including determining a first rate-of-change of force readings corresponding to delivery of a first dose of infusible fluid via the infusion pump assembly. At least a second rate-of-change of force readings corresponding to delivery of at least a second dose of infusible fluid via the infusion pump assembly is determined. An average rate-of-change of force readings is determined based, at least in part, on the first rate-of-change of force readings and the at least second rate-of-change of force readings.

[0054] One or more of the following features may be included: The average rate-of-change of force reading may be compared to a threshold rate-of-change of force reading to determine whether the average rate-of-change of force reading exceeds the threshold rate-of-change of force reading; If the average rate-of-change of force reading exceeds the threshold rate-of-change of force reading, an alarm sequence may be initiated on the infusion pump assembly.

[0055] Determining the first rate-of-change of force readings may include determining a first initial force reading before dispensing the first dose of infusible fluid. The first dose of infusible fluid may be dispensed. The first final force reading may be determined after dispensing the first dose of infusible fluid. The first rate-of-change of force readings may be determined based at least in part on the first initial force reading and the first final force reading.

[0056] One or more of the first initial force measurement and the first final force measurement may be compared to determine whether one or more of the first initial force measurement and the first final force measurement exceed a threshold force measurement, and if one or more of the first initial force measurement and the first final force measurement exceed a threshold force measurement, an alarm sequence may be initiated on the infusion pump assembly.

[0057] Determining the at least second rate-of-change of force readings may include determining at least a second initial force reading before dispensing at least a second dose of infusible fluid. The at least a second dose of infusible fluid may be dispensed. The at least a second final force reading may be determined after dispensing at least a second dose of infusible fluid. The at least a second rate-of-change of force readings may be determined, at least in part, based on the at least a second initial force reading and the at least a second final force reading.

[0058] The infusion pump assembly may include a battery assembly configured to power the infusion pump assembly. An actual voltage level of the battery assembly may be compared to a minimum voltage requirement to determine whether the actual voltage level meets the minimum voltage requirement. If the actual voltage level does not meet the minimum voltage requirement, an alarm sequence may be initiated on the infusion pump assembly.

[0059] One or more displaceable mechanical components included within the infusion pump assembly may be monitored to determine whether the one or more displaceable mechanical components have been displaced an expected displacement in response to the delivery of one or more of the first dose and the second dose of infusible fluid, and an alarm sequence may be initiated on the infusion pump assembly if the one or more displaceable mechanical components have not been displaced an expected displacement in response to the delivery of one or more of the first dose and the second dose of infusible fluid.

[0060] In another implementation, the infusion pump assembly is configured to perform an operation including determining a first rate-of-change of force readings corresponding to delivery of a first dose of infusible fluid through the infusion pump assembly, determining at least a second rate-of-change of force readings corresponding to delivery of at least a second dose of infusible fluid through the infusion pump assembly, and determining an average rate-of-change of force readings based, at least in part, on the first rate-of-change of force readings and the at least second rate-of-change of force readings.

[0061] One or more of the following features may be included: The average rate-of-change of force reading may be compared to a threshold rate-of-change of force reading to determine whether the average rate-of-change of force reading exceeds the threshold rate-of-change of force reading; If the average rate-of-change of force reading exceeds the threshold rate-of-change of force reading, an alarm sequence may be initiated on the infusion pump assembly.

[0062] Determining the first rate-of-change of force readings may include determining a first initial force reading before dispensing the first dose of infusible fluid. The first dose of infusible fluid may be dispensed. The first final force reading may be determined after dispensing the first dose of infusible fluid. The first rate-of-change of force readings may be determined based at least in part on the first initial force reading and the first final force reading.

[0063] One or more of the first initial force measurement and the first final force measurement may be compared to determine whether one or more of the first initial force measurement and the first final force measurement exceed a threshold force measurement, and if one or more of the first initial force measurement and the first final force measurement exceed a threshold force measurement, an alarm sequence may be initiated on the infusion pump assembly.

[0064] Determining the at least second rate-of-change of force readings may include determining at least a second initial force reading before dispensing at least a second dose of infusible fluid. The at least a second dose of infusible fluid may be dispensed. The at least a second final force reading may be determined after dispensing at least a second dose of infusible fluid. The at least a second rate-of-change of force readings may be determined, at least in part, based on the at least a second initial force reading and the at least a second final force reading.

[0065] The infusion pump assembly may include a battery assembly configured to power the infusion pump assembly. An actual voltage level of the battery assembly may be compared to a minimum voltage requirement to determine whether the actual voltage level meets the minimum voltage requirement. If the actual voltage level does not meet the minimum voltage requirement, an alarm sequence may be initiated on the infusion pump assembly.

[0066] One or more displaceable mechanical components included within the infusion pump assembly may be monitored to determine whether the one or more displaceable mechanical components have been displaced an expected displacement in response to the delivery of one or more of the first dose and the second dose of infusible fluid, and an alarm sequence may be initiated on the infusion pump assembly if the one or more displaceable mechanical components have not been displaced an expected displacement in response to the delivery of one or more of the first dose and the second dose of infusible fluid.

[0067] According to another aspect of the present invention, an infusion pump assembly includes a reservoir assembly configured to contain an infusible fluid. A motor assembly is configured to act on the reservoir assembly to dispense at least a portion of the infusible fluid contained within the reservoir assembly. Processing logic is configured to provide one or more control signals to the motor assembly. The one or more control signals are processable by the motor assembly to effectuate the dispensing of at least a portion of the infusible fluid contained within the reservoir assembly. The processing logic includes a primary microprocessor configured to execute one or more primary applications written in a first computer language and a safety microprocessor configured to execute one or more safety applications written in a second computer language.

[0068] One or more of the following features may be included: the primary power supply may be configured to provide primary electrical energy to at least a portion of the processing logic; the backup power supply may be configured to provide backup electrical energy to at least a portion of the processing logic when the primary power supply fails to provide primary electrical energy to at least a portion of the processing logic; the primary power supply may be a first battery and the backup power supply may be a super-capacitor assembly.

[0069] The processing logic may include one or more circuit partitioning components configured to partition the processing logic into primary processing logic and backup processing logic. The primary processing logic may include a primary microprocessor. The backup processing logic may include a secure microprocessor.

[0070] The one or more circuit partitioning components may include one or more of a diode assembly and a current limiting assembly. The diode assembly may be configured to allow the primary power supply to charge the backup power supply while prohibiting the backup power supply from providing backup electrical energy to the primary processing logic when the primary power supply fails to provide primary electrical energy to the primary processing logic.

[0071] The one or more primary applications written in a first computer language may be selected from the group consisting of an operating system, an executive loop, and a software application. The one or more safety applications written in a second computer language may be selected from the group consisting of an operating system, an executive loop, and a software application.

[0072] The primary power supply may be configured to provide electrical energy to one or more subsystems included within the infusion pump assembly. The primary power supply and the backup power supply may be configured to provide electrical energy to an audio system included within the infusion pump assembly. The audio system may be configured to provide an escalating alarm sequence in the event of loss of the beacon, the escalating alarm sequence including at least a low intensity alarm and a high intensity alarm.

[0073] The first computer language may be selected from the group consisting of Ada, Basic, Cobol, C, C++, C#, Fortran, Visual Assembler, Visual Basic, Visual J++, Java, and Java Script. The second computer language may be selected from the group consisting of Ada, Basic, Cobol, C, C++, C#, Fortran, Visual Assembler, Visual Basic, Visual J++, Java, and Java Script.

[0074] In another implementation, the infusion pump assembly includes a reservoir assembly configured to contain an infusible fluid. The motor assembly is configured to act on the reservoir assembly to dispense at least a portion of the infusible fluid contained within the reservoir assembly. The processing logic is configured to provide one or more control signals to the motor assembly. The one or more control signals are processable by the motor assembly to effectuate the dispensing of at least a portion of the infusible fluid contained within the reservoir assembly. The processing logic may include one or more circuit partitioning components configured to partition the processing logic into primary processing logic and backup processing logic. The primary microprocessor is included within the primary processing logic and configured to execute one or more primary applications written in a first computer language. The safety microprocessor is included within the backup processing logic and configured to execute one or more safety applications written in a second computer language.

[0075] One or more of the following features may be included: The one or more primary applications written in a first computer language may be selected from the group consisting of an operating system, an executive loop, and a software application. The one or more safety applications written in a second computer language may be selected from the group consisting of an operating system, an executive loop, and a software application. The primary power supply may be configured to provide electrical energy to at least a portion of the processing logic. The backup power supply may be configured to provide backup electrical energy to at least a portion of the processing logic if the primary power supply fails to provide primary electrical energy to at least a portion of the processing logic.

[0076] The first computer language may be selected from the group consisting of Ada, Basic, Cobol, C, C++, C#, Fortran, Visual Assembler, Visual Basic, Visual J++, Java, and Java Script. The second computer language may be selected from the group consisting of Ada, Basic, Cobol, C, C++, C#, Fortran, Visual Assembler, Visual Basic, Visual J++, Java, and Java Script.

[0077] In another implementation, a computer program product resides on a computer-readable medium having a plurality of instructions stored thereon. When executed by a processor, the instructions cause the processor to perform operations including receiving, on a first microprocessor executing one or more applications written in a first computer language, an initial command processable by one or more applications written in a first computer language. The initial command is converted into a modified command processable by one or more applications written in a second computer language. The modified command is provided to a second microprocessor executing one or more applications written in the second computer language.

[0078] One or more of the following features may be included: The one or more primary applications written in a first computer language may be selected from the group consisting of an operating system, an executive loop, and a software application. The one or more safety applications written in a second computer language may be selected from the group consisting of an operating system, an executive loop, and a software application.

[0079] The first microprocessor may be a primary microprocessor. The one or more applications written in the first computer language may be one or more primary applications. The second microprocessor may be a secure microprocessor. The one or more applications written in the second computer language may be one or more secure applications.

[0080] The first computer language may be selected from the group consisting of Ada, Basic, Cobol, C, C++, C#, Fortran, Visual Assembler, Visual Basic, Visual J++, Java, and Java Script. The second computer language may be selected from the group consisting of Ada, Basic, Cobol, C, C++, O#, Fortran, Visual Assembler, Visual Basic, Visual J++, Java, and Java Script.

[0081] According to another aspect of the present invention, an infusion pump assembly includes a reservoir assembly configured to contain an infusible fluid. A motor assembly is configured to act on the reservoir assembly to dispense at least a portion of the infusible fluid contained within the reservoir assembly. Processing logic is configured to control the motor assembly. A primary power supply is configured to provide primary electrical energy to at least a portion of the processing logic. A backup power supply is configured to provide backup electrical energy to at least a portion of the processing logic when the primary power supply fails to provide primary electrical energy to at least a portion of the processing logic.

[0082] One or more of the following features may be included: the primary power supply may include a first battery; the backup power supply may be a super-capacitor assembly.

[0083] The processing logic may include one or more circuit partitioning components configured to partition the processing logic into primary processing logic and backup processing logic. The primary processing logic may include a primary microprocessor. The backup processing logic may include a safety microprocessor. The one or more circuit partitioning components may include one or more of a diode assembly and a current limiting assembly.

[0084] The diode assembly may be configured to allow the primary power supply to charge the backup power supply while prohibiting the backup power supply from providing backup electrical energy to the primary processing logic if the primary power supply fails to provide primary electrical energy to the primary processing logic. The current limiting assembly may be configured to limit the amount of primary electrical energy available to charge the backup power supply.

[0085] The primary power supply may be configured to provide electrical energy to one or more subsystems included within the infusion pump assembly. The primary power supply and the backup power supply may be configured to provide electrical energy to an audio system included within the infusion pump assembly. The audio system may be configured to provide an escalating alarm sequence in the event of loss of the beacon. The escalating alarm sequence may include at least a low intensity alarm and a high intensity alarm.

[0086] In another implementation, an infusion pump assembly includes a reservoir assembly configured to contain an infusible fluid. A motor assembly is configured to act on the reservoir assembly to dispense at least a portion of the infusible fluid contained within the reservoir assembly. Processing logic is configured to control the motor assembly. A first battery is configured to provide primary electrical energy to at least a portion of the processing logic. A supercapacitor assembly is configured to provide backup electrical energy to at least a portion of the processing logic in the event that the first battery fails to provide primary electrical energy to at least a portion of the processing logic.

[0087] One or more of the following features may be included: The processing logic may include one or more circuit partitioning components configured to partition the processing logic into primary processing logic and backup processing logic; The primary processing logic may include a primary microprocessor; The backup processing logic may include a safety microprocessor; The one or more circuit partitioning components may include one or more of a diode assembly and a current limiting assembly.

[0088] In another implementation, an infusion pump assembly includes a reservoir assembly configured to contain an infusible fluid. A motor assembly is configured to act on the reservoir assembly to dispense at least a portion of the infusible fluid contained within the reservoir assembly. Processing logic is configured to control the motor assembly. A primary power supply is configured to provide primary electrical energy to at least a portion of the processing logic. A backup power supply is configured to provide backup electrical energy to at least a portion of the processing logic when the primary power supply fails to provide primary electrical energy to at least a portion of the processing logic. The processing logic includes one or more circuit partitioning components configured to partition the processing logic into primary processing logic and backup processing logic.

[0089] One or more of the following features may be included: the primary power supply may include a first battery; the backup power supply may be a supercapacitor assembly; the primary processing logic may include a primary microprocessor; and the backup processing logic may include a safety microprocessor.

[0090] The one or more circuit partitioning components may include one or more of a diode assembly and a current limiting assembly. The diode assembly may be configured to allow the primary power supply to charge the backup power supply while prohibiting the backup power supply from providing backup electrical energy to the primary processing logic when the primary power supply fails to provide primary electrical energy to the primary processing logic.

[0091] In another implementation, an alarm system includes processing logic configured to generate an alarm control signal. An RS232 line driver circuit is coupled to the processing logic and configured to receive the alarm control signal and generate an alarm output signal based at least in part on the alarm control signal. An audio driver assembly is coupled to the RS232 line driver circuit and configured to receive the alarm output signal and generate an audible alarm signal based at least in part on the alarm output signal.

[0092] One or more of the following features may be included: The audio driver assembly may include a piezoelectric diaphragm. An alarm system may be included within the infusion pump assembly. The infusion pump assembly includes a reservoir assembly configured to contain an infusible fluid. The motor assembly may be configured to act on the reservoir assembly to dispense at least a portion of the infusible fluid contained within the reservoir assembly. The primary power supply may be configured to provide primary electrical energy to at least a portion of the processing logic. The backup power supply may be configured to provide backup electrical energy to at least a portion of the processing logic when the primary power supply fails to provide primary electrical energy to at least a portion of the processing logic. The processing logic may further be configured to control the motor assembly.

[0093] According to another aspect of the present invention, a medium connector includes a passageway configured to allow medium flow and a multi-portion engagement surface disposed about the passageway. The multi-portion engagement surface includes a first surface portion and a second surface portion. The first surface portion is configured to provide an interference fit with a corresponding sealing surface of the mating connector. The second surface portion is configured to provide a clearance fit with the corresponding sealing surface of the mating connector. The ratio of the first surface portion to the second surface portion is selected to adjust the engagement force between the medium connector and the mating connector.

[0094] One or more of the following features may be included: the mating connector may comprise a Luer taper connector; the multi-portion engagement surface may comprise a tapered surface, where a first surface portion may have a first taper angle and a second surface portion may have a second taper angle that is less than the first taper angle; and the second surface portion may be generally cylindrical. The multi-portion engagement surface may include a tapered surface, where a first surface portion may have a first taper angle and a second surface portion may have a second taper angle greater than the first taper angle. The second surface portion may include one or more recesses. The one or more recesses may include one or more radial slots. The one or more recesses may include one or more longitudinal slots.

[0095] The medium connector may include one or more retention features, which may include one or more snap-fit ​​features.

[0096] According to another embodiment, a medium connector includes a passageway configured to allow medium flow and a multi-portion engagement surface disposed about the passageway. The multi-portion engagement surface includes a first surface portion and a second surface portion. The first surface portion has a first taper angle configured to provide an interference fit with a corresponding sealing surface of the mating connector. The second surface portion has a second taper angle configured to provide a clearance fit with the corresponding sealing surface of the mating connector. The ratio of the first surface portion to the second surface portion is selected to adjust the engagement force between the medium connector and the mating connector.

[0097] One or more of the following features may be included: The mating connector may include a luer taper connector. The second taper angle may be less than the first taper angle. The second surface portion may be generally cylindrical. The second taper angle may be greater than the first taper angle. The medium connector may include one or more retention features. The one or more retention features may include one or more snap-fit ​​features.

[0098] The details of one or more implementations are set forth in the accompanying drawings and description below. Other features and advantages will be apparent from the description, drawings, and claims.

[0099] These and other features and advantages of the present invention will be better understood from a reading of the following detailed description taken in conjunction with the drawings. [Brief explanation of the drawings]

[0100] [Figure 1A] 1A-1B are front and rear isometric views of an infusion pump assembly. [Figure 1B] 1A-1B are front and rear isometric views of an infusion pump assembly. [Figure 1C]1C-1E are front and rear views of the infusion pump assembly of FIG. 1. FIG. 1F is a front isometric view of the infusion pump assembly of FIG. [Figure 1D] 1C-1E are front and rear views of the infusion pump assembly of FIG. 1. FIG. 1F is a front isometric view of the infusion pump assembly of FIG. [Figure 1E] 1C-1E are front and rear views of the infusion pump assembly of FIG. 1. FIG. 1F is a front isometric view of the infusion pump assembly of FIG. [Figure 1F] 1C-1E are front and rear views of the infusion pump assembly of FIG. 1. FIG. 1F is a front isometric view of the infusion pump assembly of FIG. [Figure 2] FIG. 2 is a diagrammatic view of the infusion pump assembly of FIG. [Figure 3A] FIG. 3A is a top-level view of an infusion pump assembly, according to one embodiment. [Figure 3B] FIG. 3B is an exploded view of the drive mechanism of the infusion pump assembly of FIG. 3A. [Figure 3C] FIG. 3C is an isometric view of one embodiment of a reservoir and locking hub assembly, according to one embodiment. [Figure 3D] FIG. 3D is an exploded isometric view of a locking hub and reservoir, according to one embodiment. [Figure 3E] FIG. 3E is an isometric view of one embodiment of a reservoir assembly. [Figure 3F] FIG. 3F shows an embodiment of a pump barrel locking mechanism. [Figure 3G] FIG. 3G shows an enlarged view according to FIG. 3F. [Figure 3H] 3H-3I show the relationship of the drive screw to the plunger rod for the infusion pump of FIG. 3A. [Figure 3I] 3H-3I show the relationship of the drive screw to the plunger rod for the infusion pump of FIG. 3A. [Figure 3J] FIG. 3J shows the connection of one embodiment of the reservoir to a tubing set. [Figure 3K]FIG. 3K illustrates another method of connecting one embodiment of the reservoir to a tubing set. [Figure 3L] FIG. 3L shows an adapter for using a small diameter reservoir with a pump assembly, according to one embodiment. [Figure 3M] 3M-3N are on-axis views of the adapter of FIG. 3L. [Figure 3N] 3M-3N are on-axis views of the adapter of FIG. 3L. [Figure 4A] FIG. 4A is an exploded view of one embodiment of a reservoir and locking hub assembly, along with portions of the loading and drive assemblies of one embodiment of an infusion pump assembly. [Figure 4B] 4B-4D are partial views of the loading of the reservoir assembly onto the drive assembly. [Figure 4C] 4B-4D are partial views of the loading of the reservoir assembly onto the drive assembly. [Figure 4D] 4B-4D are partial views of the loading of the reservoir assembly onto the drive assembly. [Figure 4E] 4E-4F are top and bottom views of the hub and battery end cap according to one embodiment of the infusion pump device. [Figure 4F] 4E-4F are top and bottom views of the hub and battery end cap according to one embodiment of the infusion pump device. [Figure 4G] 4G-4I are bottom, side, and top views, respectively, of one embodiment of a locking disk. [Figure 4H] 4G-4I are bottom, side, and top views, respectively, of one embodiment of a locking disk. [Figure 4I] 4G-4I are bottom, side, and top views, respectively, of one embodiment of a locking disk. [Figure 4J] 4J-4L are isometric views of one embodiment of a locking disk. [Figure 4K] 4J-4L are isometric views of one embodiment of a locking disk. [Figure 4L]4J-4L are isometric views of one embodiment of a locking disk. [Figure 4M] 4M-4N are partial perspective views of loading of the reservoir assembly onto the drive assembly according to one embodiment of the infusion pump device. [Figure 4N] 4M-4N are partial perspective views of loading of the reservoir assembly onto the drive assembly according to one embodiment of the infusion pump device. [Figure 5A] FIG. 5A is an isometric view of one embodiment of a plunger and plunger rod arrangement. [Figure 5B] FIG. 5B is an isometric view of one embodiment of a reservoir and locking hub assembly. [Figure 5C] FIG. 5C is an isometric view of the plunger and plunger rod arrangement with the reservoir and locking hub assembly shown in FIG. 5B. [Figure 5D] 5D-5E are isometric and cross-sectional views, respectively, of a plunger seal arrangement, according to one embodiment. [Figure 5E] 5D-5E are isometric and cross-sectional views, respectively, of a plunger seal arrangement, according to one embodiment. [Figure 5F] FIG. 5F is a cross-sectional cutaway view of the assembled plunger device of FIG. 5C. [Figure 5G] 5G-5P are various embodiments of plunger seal arrangements. [Figure 5H] 5G-5P are various embodiments of plunger seal arrangements. [Figure 5I] 5G-5P are various embodiments of plunger seal arrangements. [Figure 5J] 5G-5P are various embodiments of plunger seal arrangements. [Figure 5K] 5G-5P are various embodiments of plunger seal arrangements. [Figure 5L] 5G-5P are various embodiments of plunger seal arrangements. [Figure 5M] 5G-5P are various embodiments of plunger seal arrangements. [Figure 5N] 5G-5P are various embodiments of plunger seal arrangements. [Figure 5O] 5G-5P are various embodiments of plunger seal arrangements. [Figure 5P] 5G-5P are various embodiments of plunger seal arrangements. [Figure 6A] 6A-6B are diagrams of one embodiment of a filling aid device. [Figure 6B] 6A-6B are diagrams of one embodiment of a filling aid device. [Figure 6C] 6C-6D are isometric views of the filling aid device of FIGS. 6A-6B with the plunger rod attached to and detached from the plunger rod, respectively. [Figure 6D] 6C-6D are isometric views of the filling aid device of FIGS. 6A-6B with the plunger rod attached to and detached from the plunger rod, respectively. [Figure 6E] 6E-6F are isometric views of one embodiment of a filling aid device with a plunger rod attached to and detached from the plunger rod, respectively. [Figure 6F] 6E-6F are isometric views of one embodiment of a filling aid device with a plunger rod attached to and detached from the plunger rod, respectively. [Figure 6G] 6G-6I are isometric views of an alternative embodiment of a filling aid with a plunger rod. [Figure 6H] 6G-6I are isometric views of an alternative embodiment of a filling aid with a plunger rod. [Figure 6I] 6G-6I are isometric views of an alternative embodiment of a filling aid with a plunger rod. [Figure 7A] 7A-7B are isometric views of various portions of one embodiment of an infusion pump assembly. [Figure 7B]7A-7B are isometric views of various portions of one embodiment of an infusion pump assembly. [Figure 7C] 7C-7D are isometric views of a reservoir assembly with a drive screw and strain gauge according to one embodiment of an infusion pump device. [Figure 7D] 7C-7D are isometric views of a reservoir assembly with a drive screw and strain gauge according to one embodiment of an infusion pump device. [Figure 7E] FIG. 7E is an enlarged isometric view of a plunger rod with an optical displacement sensor according to one embodiment of the infusion pump device. [Figure 8A] 8A-8D are various alternative embodiments of the reservoir assembly. [Figure 8B] 8A-8D are various alternative embodiments of the reservoir assembly. [Figure 8C] 8A-8D are various alternative embodiments of the reservoir assembly. [Figure 8D] 8A-8D are various alternative embodiments of the reservoir assembly. [Figure 9A] 9A-9B are cross-sectional views of a media connector assembly included within the infusion pump assembly of FIG. [Figure 9B] 9A-9B are cross-sectional views of a media connector assembly included within the infusion pump assembly of FIG. [Figure 9C] 9C-9D are cross-sectional views of a media connector assembly included within the infusion pump assembly of FIG. [Figure 9D] 9C-9D are cross-sectional views of a media connector assembly included within the infusion pump assembly of FIG. [Figure 9E] 9E-9F are cross-sectional views of a media connector assembly included within the infusion pump assembly of FIG. [Figure 9F] 9E-9F are cross-sectional views of a media connector assembly included within the infusion pump assembly of FIG. [Figure 9G]9G-9H are cross-sectional views of a media connector assembly included within the infusion pump assembly of FIG. [Figure 9H] 9G-9H are cross-sectional views of a media connector assembly included within the infusion pump assembly of FIG. [Figure 9I] 9I-9J are cross-sectional views of a media connector assembly included within the infusion pump assembly of FIG. [Figure 9J] 9I-9J are cross-sectional views of a media connector assembly included within the infusion pump assembly of FIG. [Figure 10A] 10A is an isometric view of a removable cover assembly for use with the infusion pump assembly of FIG. 1. FIG. [Figure 10B] FIG. 10B is an alternative isometric view of the removable cover assembly of FIG. 10A. [Figure 10C] FIG. 10C is a cross-sectional view of the removable cover assembly of FIG. 10A. [Figure 11] FIG. 11 is an alternative isometric view of the removable cover assembly of FIG. 10A. [Figure 12A] 12A-12D are alternative isometric views of the removable cover assembly of FIG. [Figure 12B] 12A-12D are alternative isometric views of the removable cover assembly of FIG. [Figure 12C] 12A-12D are alternative isometric views of the removable cover assembly of FIG. [Figure 12D] 12A-12D are alternative isometric views of the removable cover assembly of FIG. [Figure 12E] FIG. 12E is an isometric view of one embodiment of a removable cover assembly. [Figure 12F] FIG. 12F is a bottom view of one embodiment of a removable cover assembly. [Figure 12G] FIG. 12G is an isometric view of one embodiment of a removable cover assembly with a power supply assembly. [Figure 12H]FIG. 12H is an isometric exploded view of FIG. 12G. [Figure 12I] 12I-12J are isometric views of the power supply interface assembly. [Figure 12J] 12I-12J are isometric views of the power supply interface assembly. [Figure 12K] FIG. 12K is an isometric view of one embodiment of a removable cover assembly. [Figure 12L] FIG. 12L is a bottom view of one embodiment of a removable cover assembly. [Figure 12M] FIG. 12M is an isometric view of one embodiment of a removable cover assembly with a power supply assembly. [Figure 12N] FIG. 12N is an isometric exploded view of FIG. 12G. [Figure 12O] 12O-12P are isometric views of the power supply interface assembly. [Figure 12P] 12O-12P are isometric views of the power supply interface assembly. [Figure 13] FIG. 13 is a diagrammatic view of the infusion pump assembly of FIG. [Figure 14] FIG. 14 is a flowchart of the steps performed by the infusion pump assembly of FIG. [Figure 15] FIG. 15 is a flowchart of the steps performed by the infusion pump assembly of FIG. [Figure 16] FIG. 16 is a timeline illustrating multiple discrete injection events. [Figure 17] FIG. 17 is a more detailed view of the two discrete injection events contained within FIG. [Figure 18] FIG. 18 is a diagram of a memory array contained within the infusion pump assembly of FIG. [Figure 19] FIG. 19 is a flowchart of the steps performed by the infusion pump assembly of FIG. [Figure 20] FIG. 20 is an exemplary diagram of one embodiment of a remote control assembly. [Figure 21] FIG. 21 is one embodiment of a cannula and tubing assembly. [Figure 22] FIG. 22 is one embodiment of a cannula and tubing assembly. [Figure 23] FIG. 23 is one embodiment of a method for preventing over-delivery of an infusible fluid. [Figure 24] FIG. 24 is one embodiment of a reservoir housing and reservoir assembly. [Figure 25] FIG. 25 is one embodiment of a method for determining when the pusher is in contact with the plunger contact. [Figure 26A] FIG. 26A is an illustration of methods, systems, and devices according to some embodiments. [Figure 26B] FIG. 26B is a flowchart of the method according to FIG. 26A. DETAILED DESCRIPTION OF THE INVENTION

[0101] 1A-1F, an infusion pump assembly 100 is shown that may be housed within an enclosure assembly 102. The infusion pump assembly 100 may include a display system 104 that may be visible through the enclosure assembly 102. One or more switch assemblies / input devices 106, 108, 110 may be located around various portions of the enclosure assembly 102. The enclosure assembly 102 may include an infusion port assembly 112 to which a cannula assembly 114 may be releasably coupled. A removable cover assembly 116 may provide access to a power supply cavity 118 (shown in phantom in FIG. 2). In some embodiments, the infusion pump assembly may be any infusion assembly, including, but not limited to, those described in U.S. Patent No. 7,306,578, issued December 11, 2007, entitled "Loading Mechanism for Infusion Pump" (Attorney Docket No. C54), now abandoned U.S. patent application Ser. No. 10 / 151,733, issued May 20, 2002, entitled "Infusion Set for a Fluid Pump" (Attorney Docket No. D13), and U.S. patent application Ser. No. 11 / 533,882, filed September 21, 2006, entitled "Infusion Set for a Fluid Pump," now U.S. Patent Application Publication No. US-2007-0049870-A1, published March 1, 2007 (Attorney Docket No. E62), all of which are incorporated herein by reference in their entirety.In some embodiments, the one or more switch assemblies / input devices may be any device, including, but not limited to, those described in U.S. Patent Application No. 11 / 999,268, filed December 4, 2007, entitled Medical Device Including a Slider Assembly, now U.S. Patent Application Publication No. US-2008-0177900-A1 (Attorney Docket No. F14), published July 24, 2008, and similar to those described therein, all of which are incorporated herein by reference in their entirety.

[0102] 2, a diagram of infusion pump assembly 100 is shown. Infusion pump assembly 100 may be configured to deliver an infusible fluid 200 to a user 202. Infusible fluid 200 may be delivered intravenously (i.e., into a vein), subcutaneously (i.e., into the skin), intra-arterially (i.e., into an artery), and epidurally (i.e., into the epidural space). Examples of infusible fluid 200 may include, but are not limited to, insulin, nutrients, saline, antibiotics, analgesics, anesthetics, hormones, vasoactive agents, and chelating agents, as well as any other therapeutic fluid.

[0103] Infusion pump assembly 100 may include processing logic 204 that performs one or more processes that may be required for the proper operation of infusion pump assembly 100. Processing logic 204 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 processing logic 204 with one or more subsystems.

[0104] Examples of subsystems interconnected with processing logic 204 may include, but are not limited to, input system 206, memory system 208, display system 104, vibration system 210, audio system 212, motor assembly 214, force sensor 216, and displacement detection device 218. Infusion pump assembly 100 may include a primary power supply 220 (e.g., a battery) configured to be removably installable within power supply cavity 118 and to provide power to at least a portion of processing logic 204 and one or more of the subsystems (e.g., input system 206, memory system 208, display system 104, vibration system 210, audio system 212, motor assembly 214, force sensor 216, and displacement detection device 218).

[0105] Infusion pump assembly 100 may include a reservoir assembly 222 configured to contain infusible fluid 200. In some embodiments, reservoir assembly 222 may be a reservoir assembly similar to that described in U.S. Patent No. 7,498,563 (Attorney Docket No. D78), issued March 3, 2009, entitled "Optical Displacement Sensor for Infusion Devices," which is incorporated herein by reference in its entirety. In other embodiments, the reservoir assembly may be any assembly upon which a fluid may be acted upon such that at least a portion of the fluid may flow out of the reservoir assembly; for example, the reservoir assembly may include, but is not limited to, a barrel with a plunger, a cassette, or a container constructed at least in part of a flexible membrane, in various embodiments.

[0106] Plunger rod assembly 224 may be configured to displace infusible fluid 200 from reservoir assembly 222 through cannula assembly 114 (which may be coupled to infusion pump assembly 100 via injection port assembly 112) so that infusible fluid 200 may be delivered to user 202. In this particular embodiment, plunger rod assembly 224 is shown as displaceable by partial nut assembly 226, which may engage lead screw assembly 228, which may be rotatable by motor assembly 214 in response to signals received from processing logic 204. In this particular embodiment, the combination of motor assembly 214, plunger rod assembly 224, partial nut assembly 226, and lead screw assembly 228 may form a pump assembly that achieves dispensing of infusible fluid 200 contained within reservoir assembly 222. An example of partial nut assembly 226 may include, but is not limited to, a nut assembly configured to wrap around lead screw assembly 228, for example, 30 degrees. In some embodiments, the pump assembly may be similar to that described in U.S. Patent No. 7,306,578, issued December 11, 2007 (Attorney Docket No. C54), entitled "Loading Mechanism for Infusion Pump," which is incorporated herein by reference in its entirety.

[0107] During operation of infusion pump assembly 100, infusible fluid 200 may be delivered to user 202, for example, according to a defined delivery schedule. For illustrative purposes only, assume infusion pump assembly 100 is configured to deliver 0.00025 mL of infusible fluid 200 to user 202 every three minutes. Thus, every three minutes, processing logic 204 may provide an appropriate drive signal to motor assembly 214 to enable motor assembly 214 to rotate lead screw assembly 228 an appropriate amount such that partial nut assembly 226 (and thus plunger rod assembly 224) may be displaced an appropriate amount in the direction of arrow 230 so that 0.00025 mL of infusible fluid 200 is provided to user 202 (via cannula 114). It should be understood that the volume of infusible fluid 200 that may be provided to user 202 may vary based, at least in part, on the properties of the infusible fluid (e.g., type of fluid, concentration, etc.), user parameters (e.g., type of treatment, dosage, etc.). As such, the foregoing exemplary embodiments should not be construed as limitations on the present disclosure.

[0108] Force sensor 216 may be configured to provide processing logic 204 with information regarding the force required to drive plunger assembly 224 into reservoir assembly 222. Force sensor 216 may include one or more strain gauges and / or pressure sensing gauges and may be located between motor assembly 214 and an immovable object (e.g., bracket assembly 232) that may be included within infusion pump assembly 100.

[0109] In one embodiment, force sensor 216 includes four strain gauges (not shown), such that two of the four strain gauges are configured to compress when driving plunger assembly 224 into reservoir assembly 222 and two of the four strain gauges are configured to expand when driving plunger assembly 224 into reservoir assembly 222. The four strain gauges (not shown) may be connected to a Wheatstone bridge (not shown), which generates an analog force signal (not shown) that is a function of the pressure sensed by force sensor 216. The analog force signal (not shown) generated by force sensor 216 may be provided to an analog-to-digital converter (not shown), which may convert the analog force signal (not shown) to a digital force signal (not shown), which may be provided to processing logic 204. An amplifier assembly (not shown) may be placed before the analog-to-digital converter and, for example, configured to amplify the output of force sensor 216 to a level sufficient for processing by the analog-to-digital converter.

[0110] The motor assembly 214 may be configured, for example, as a brushed DC electric motor. Additionally, the motor assembly 214 may include a reducer assembly (not shown) that requires the motor assembly 214 to rotate at 3000 revolutions for each rotation of the lead screw assembly 228, thus increasing the torque and resolution of the motor assembly 214 by 3000 times.

[0111] 3A is an overall view of an infusion pump, according to one embodiment. Pump assembly 300 contains the components needed to deliver a medication or any liquid to a user in reservoir assembly 302. Reservoir assembly 302 may contain enough liquid, such as, but not limited to, a medication, such as insulin, for several days for a typical user. Tubing set 304 connected to reservoir assembly 302 includes a cannula (not shown) through which the medication is delivered to the user.

[0112] Referring also to FIG. 3B, an exploded view of one embodiment of the drive mechanism of the infusion pump is shown. Reservoir assembly 302 may include a reservoir 306, a plunger 308, and a plunger rod 310. Reservoir 306 may contain a medication for delivery to a user and has a variable internal volume. The internal volume may be the maximum liquid capacity of reservoir 306. Plunger 308 may be inserted into the bottom of reservoir 306 and may change the volume of reservoir 306 as plunger 308 is displaced along the longitudinal axis of reservoir 306. The plunger rod 310 may be connected to the plunger 308 with the longitudinal axis of the plunger rod displaced from and parallel to the longitudinal axis of the reservoir 306. The plunger rod 310 may be threaded over at least a portion of its length. As shown in this embodiment, a cylindrical pump barrel 312 receives the reservoir assembly 302. The pump barrel 312 may restrain the plunger rod 310 and orient the plunger rod 310 along the longitudinal axis of the pump barrel 312. The pump barrel 312 may be contained in the pump assembly 300 and, in some embodiments, may contain a locking tab 317 that may prevent rotation of the pump barrel 312 relative to the pump assembly 300. A gearbox 316 within the pump assembly 300 may contain the drive screw 314 along with a motor and gears that rotate the drive screw 314. The drive screw 314 may be threaded, and the longitudinal axis of the screw may be aligned parallel to or offset from the longitudinal axis of the pump barrel 312. A locking hub 318 may be attached to the top of the reservoir 306.

[0113] 3C-3D, one embodiment of a reservoir assembly 302 with a locking hub 318 is shown. The reservoir 306 may be sized to accommodate any desired volume. In the exemplary embodiment, the reservoir 306 may accommodate a 2.5 ml volume, although in various other embodiments, the reservoir 306 may be sized to accommodate smaller or larger volumes. As discussed above, the reservoir 306 may change as the plunger is displaced along the longitudinal axis of the reservoir 306. In the exemplary embodiment, the locking hub 318 may be connected to a tubing set (not shown; an example of a tubing set is shown in FIG. 3A as 304) so ​​that liquid in the reservoir may flow through the locking hub and to the tubing. In some embodiments, such as the exemplary embodiment shown, the reservoir 306 may also include a reservoir alignment tab 307 and a reservoir bottom 305. 3C-3D, plunger rod 310, in an exemplary embodiment, may include a threaded portion 320 and a notched portion 322. The threaded portion may threadably engage drive screw 314. Notched portion 322, in an exemplary embodiment, may be used to encode information about reservoir assembly 302, including, but not limited to, the information, methods, and devices described in U.S. Patent No. 7,498,563, issued March 3, 2009, entitled Optical Displacement Sensor for Infusion Devices (Attorney Docket No. D78), which is incorporated herein by reference in its entirety.

[0114] Referring also to FIG. 3D , an exemplary embodiment of the locking hub 318 and the mating male portion 324 of the reservoir 306 is shown. The reservoir 306 is shown without the reservoir bottom 305 shown in FIG. 3C . Tapered luer connections are described in further detail below. As shown in FIG. 3D , the locking hub 318 may include a female part 329 and a tab 326, while the reservoir 306 may include a male part 324 and a slot 328. The male part 324 and the female part 329 may mate to form a luer connection. The tab 326 and the slot 328 may lock together when one part is mated and pivoted relative to its mating part such that the tab 326 can slide within the slot 328.

[0115] Referring now to FIG. 3E, another embodiment of a reservoir assembly 330 is shown. In this embodiment, the hub portion 332 and reservoir portion 334 are connected and, in one embodiment, molded as a single piece.

[0116] Referring also to FIG. 3F, a pump barrel locking mechanism for an embodiment of the device is shown. Pump barrel 312 includes a clearance hole (not shown, shown in FIG. 3H as 340) that guides plunger rod 310 during insertion of reservoir assembly 302 into pump barrel 312. To ensure that drive screw 314 does not interfere with plunger rod 310 during insertion of reservoir assembly 302, pump barrel 312 maintains a fixed position relative to pump assembly 300. The position of pump barrel 312 relative to pump assembly 300 may be maintained by, for example, a locking tab 317 included on pump barrel 312 that engages with a pump barrel stop 342 in pump assembly 300. Locking hub 318 may include a flange 338 that, when locking hub 318 is pivoted, removes locking tab 317 from pump barrel stop 342, allowing locking hub 318 to rotate pump barrel 312.

[0117] 3H-3I, which show views along the longitudinal axis of the pump barrel 312 illustrating the relationship of the drive screw 314 to the plunger rod portion in the primed and engaged positions, respectively. The reservoir assembly 302 is installed for primed so that the plunger rod 310 does not contact the drive screw 314, as shown in FIG. 3H. When the pump barrel 312 is properly installed in the pump assembly 300, the clearance of the plunger rod 310 from the drive screw 314 is determined by the placement of a clearance hole 340 at the base of the pump barrel 312, which receives and guides the plunger rod 310. The clearance hole 340 may be tapered to facilitate insertion of the plunger rod 310. The drive screw 314 fits within the clearance hole 340 in the pump barrel 312. Once reservoir assembly 302 is inserted into pump assembly 300, pump barrel 312 is rotated by locking hub 318, causing plunger rod 310 to pivot and engage drive screw 314, as shown in Figure 3I. This embodiment advantageously simplifies reservoir loading.

[0118] In some embodiments, the threads of the plunger rod and the drive screw are buttress threads. These embodiments may be advantageous in that they eliminate recoil forces on the plunger rod perpendicular to the longitudinal axis of the rod. Such recoil forces can deflect the rod and skip threads on the drive screw, resulting in insufficient delivery of medication to the user. Buttress threads eliminate the perpendicular component of the recoil force.

[0119] Referring also to Figure 3J, in some embodiments, the locking hub 318 may be connected to the reservoir 306 by a tapered luer connection. The reservoir 306 has a male luer taper integrally molded into the top 344 of the reservoir. Surrounding the male luer is an annulus with internal female threads. Similarly, the locking hub 318 contains a mating female luer and threaded male connection.

[0120] In another embodiment, a needle connection is made between the reservoir 306 and the locking hub 318. As shown in Figure 3K, the reservoir includes a rubber septum 346 that is attached to the reservoir with a crimped metal collar. A needle 348 that is integral with the hub punctures the septum and fluid can then flow from the reservoir to the tubing set.

[0121] In other embodiments, as shown in FIG. 3L, an adapter 350 is provided to allow a reservoir 352 having a diameter significantly smaller than the diameter of the pump barrel to be used with the pump assembly 300. The adapter 350 may be a separate component or may be incorporated into a locking hub 354. The locking hub 354 may, in some embodiments, be one of the embodiments described herein and sized accordingly. The adapter 350 aligns and offsets the reservoir 352 axis parallel to the longitudinal axis of the pump barrel so that the plunger rod 356, when rotated, engages with the drive screw (not shown). FIGS. 3M-3N show on-axis views of the small-diameter reservoir 352 when positioned within the adapter 350. As will be apparent, the offset provided by the adapter allows the plunger rod 356, when mated with the plunger 308 and reservoir 352, to engage the drive screw 314, similar to the first embodiment described above.

[0122] Referring now to FIG. 4A, another embodiment of a drive mechanism for an infusion pump is shown. As shown in this embodiment, a cylindrical pump barrel 312, shown here inside a pump barrel housing 360, receives the reservoir assembly 302. The pump barrel 312 terminates in a locking disk 400. The pump barrel 312 restrains the plunger rod 310 and orients the plunger rod 310 along the longitudinal axis of the pump barrel 312. The pump barrel 312 is contained in a pump barrel housing 360, which is contained in the pump assembly 300. The locking disk 400 contacts a locking tab (shown in FIG. 4B as 402) located in the pump gearbox 364, in the exemplary embodiment. The locking tab 402 prevents rotation of the locking disk 400 relative to the pump assembly 300. However, in some embodiments, the locking disk 400 may not include the locking tab 402. A gearbox 364 within the pump assembly 300 includes the drive screw 314, and as discussed above, in some embodiments, a motor and gears that rotate the locking tab 402 to lock the locking disk 400. The drive screw 314 is threaded so that the longitudinal axis of the screw is aligned parallel to and displaced from the longitudinal axis of the pump barrel 312. A locking hub 318 is attached to the top of the reservoir 306.

[0123] 4A , in the embodiment shown, plunger rod 310 is connected to plunger rod 308. In the exemplary embodiment, plunger rod 310 and plunger rod 308 are a single molded piece. An O-ring 366 fits over plunger 308. However, in some embodiments, the O-ring may be molded into plunger 308.

[0124] 3C-3D, locking hub 318 additionally includes locking hub alignment tab 325. As shown in FIG. 3C, once locking hub 318 and reservoir 306 are mated, locking hub alignment tab 325 and reservoir alignment tab 307 are aligned with one another. Referring also to FIGS. 4E-4F, pump assembly 300 includes hub and battery end cap 404. The hub section of hub and battery end cap 404 includes a complementary opening for locking hub 318, including locking hub alignment tab 325.

[0125] Thus, once reservoir assembly 302 is mated with locking hub 318, in order to load the reservoir into pump barrel 312, the reservoir must be properly oriented relative to locking hub alignment tabs 325 and the complementary openings in hub and battery end cap 404. Thus, reservoir alignment tabs 307 are also aligned with locking hub alignment tabs 325.

[0126] 4G-4L, a locking disk 400 is shown. The locking disk 400 includes a clearance hole 340 that, in the exemplary embodiment, is tapered for easy insertion, but in some embodiments is not tapered. Additionally, a reservoir tab opening 406, a plunger rod support 412, and first and second locking tab notches 408, 410 are shown. As discussed above, the reservoir alignment tab 307 is aligned with the locking hub alignment tab 325. The orientation ensured by the hub and battery end cap 404 ensures that the plunger rod 310 is correctly oriented to fit through the clearance hole 340, the reservoir alignment tab 307 engages with the reservoir tab opening 406, and the reservoir bottom 305 displaces the locking tab 402.

[0127] In some embodiments, locking disk 400 may include only first locking tab notch 408, or in some embodiments, may not include any locking tab notches. Locking tab notches 408, 410 maintain the orientation of locking disk 400 to facilitate loading of the reservoir and locking hub assembly. Second locking tab notch 408 also helps maintain the relationship between plunger rod 310 and drive screw 314. Additionally, while reservoir tab opening 406 is included in the exemplary embodiment of locking disk 400, some embodiments of locking disk 400 do not include reservoir tab opening 406. In these embodiments, the reservoir does not include reservoir alignment tab 307 (shown in FIGS. 3C-3D ).

[0128] In the exemplary embodiment, reservoir tab openings 406, along with reservoir alignment tabs 307, assist in rotation of locking disk 400. When loading the reservoir and locking hub assembly into pump assembly 300, a user aligns the reservoir and locking hub assembly with the hub and battery cap 404, drops the reservoir and locking hub assembly into pump barrel 312, and applies slight pressure to locking hub 318. The user then applies torque to locking hub 318 to complete the loading process. When locking disk 400 includes reservoir tab openings 406 and the reservoir includes reservoir alignment tabs 307, as in the exemplary embodiment, torque applied to the locking hub is transmitted from reservoir alignment tabs 307 to locking disk 400, rather than from locking hub 318 to plunger rod 310. Thus, in the exemplary embodiment, the reservoir alignment tab 307, along with the reservoir tab opening 406, cooperate to take up torque applied to the reservoir and locking hub assembly, which helps maintain the integrity of the plunger rod 310 while also ensuring proper engagement of the plunger rod 310 onto the drive screw 314.

[0129] Referring also to FIG. 4B, a bottom view of the locking disk 400 is shown with the locking tab 402 engaged with one of the locking tab notches 408. The clearance hole 340 is shown lacking the plunger rod. Thus, the locking disk 400 is shown in the locked, unloaded position. The drive screw 314 is shown, as is the plunger rod support 412. Referring also now to FIG. 4C, the plunger rod 310 is shown fitted through the clearance hole 340. The reservoir alignment tab 307 is shown engaged with the reservoir tab opening 406, with the locking tab 402 deflected away from the locking tab notch 408.

[0130] A plunger rod support 412 is shown along a portion of the plunger rod 310. The plunger rod support 412 helps maintain the integrity of the relationship between the plunger rod 310 and the drive screw 314 so that the drive screw 314 of the plunger rod 310 remains connected and the plunger rod 310 is not deflected.

[0131] 4D, locking disk 400 is shown after rotation and reservoir loading is complete, i.e., in the loaded position. Plunger rod 310 is engaged with drive screw 314. Second locking tab notch 410 is now engaged with locking tab 402. Thus, the locking disc 400 is locked from continuing to rotate further.

[0132] 4M-4N, sequential illustrations of reservoir loading and engagement of drive screw 314 with plunger rod 310 are shown. When plunger rod 310 fits through the clearance hole, reservoir 306 disengages locking tab 402 from first locking tab notch 408. Reservoir alignment tab 307 (the other tab is hidden) mates with reservoir tab opening 406. As shown in FIG. 4N, plunger rod 310 is engaged with drive screw 314. Locking tab 402 is engaged with second locking tab notch 410.

[0133] In an exemplary embodiment, loading the reservoir into the pump barrel and engaging the plunger rod with the drive screw involves two steps. First, align the locking hub alignment tabs with the hub and battery end cap and drop the reservoir and locking hub assembly into the pump barrel (the plunger rod is essentially aligned with the clearance hole in the locking disk). Second, rotate the locking hub until rotation stops, i.e., until the locking tab engages the second locking tab notch. In an exemplary embodiment, referring again to FIG. 4F , the hub and battery end cap 404 may include a loading alignment feature 420, and the reservoir may also include markings or other alignment features; aligning the markings on the reservoir with the loading alignment feature 420 ensures that the reservoir assembly is aligned for dropping the reservoir and locking hub assembly into the pump barrel and ensures completion of the loading step. In the exemplary embodiment, the loading alignment feature 420 is a notch molded into the plastic of the hub and battery end cap 404. However, in other embodiments, the loading alignment feature 420 may be a differently shaped step, a raised depression, a notch, or a painted marking—any feature that may be utilized by a user when loading the reservoir and locking hub assembly. The complementary feature on the reservoir may be any marking, for example, a painted marking with an indication of the direction of loading, such as “pump →,” “→,” or in some embodiments, a simple vertical line of any length, a dot, or other symbol that may be utilized by a user when loading the reservoir and locking hub assembly. In these embodiments, these alignment features further simplify the method of loading the reservoir and locking hub assembly into the pump assembly.

[0134] Referring again to FIG. 1C , the hub and battery end cap are shown with the locking hub 318 and battery cap 116 attached. In this embodiment of the pump assembly, the locking hub 318 seats flush with the pump assembly. Thus, when loading the reservoir, once the locking hub is rotated so that the locking hub is flush with the pump assembly body, loading is complete. Thus, reservoir loading is advantageously simplified in that the alignment features ensure that the reservoir, plunger rod, and reservoir alignment tabs are aligned with the locking disk when dropped into the pump barrel, and rotation of the locking hub until it is flush with the pump assembly ensures that the reservoir is loaded and the plunger rod is threaded onto the drive screw.

[0135] 5A, there is shown a diagram of an exemplary embodiment of plunger rod 310 and plunger 308. Plunger rod 308 includes two O-rings 366. In some embodiments, O-rings 366 and plunger rod 308 may be one piece and may be made of a material that provides sufficient sealing properties.

[0136] 5B-5C, another embodiment of the reservoir assembly 502 is shown along with the locking hub 318. In this embodiment, the plunger seal 506 is designed to function as a double O-ring plunger, but is molded as a single piece. The plunger seal 506 fits over the plunger 504, which in some embodiments is made of plastic and in some embodiments is made of the same plastic as the plunger rod 310. A plunger cap 508 fits over the plunger seal 506. The reservoir 306 and reservoir bottom 305, in some embodiments, may be as described in the above embodiments. Referring also to FIGS. 5D-5E, the plunger seal 506 is shown. As shown, the ring-shaped feature at the top of the seal is thicker than the ring-shaped feature at the bottom. However, in other embodiments, the bottom ring-shaped feature may be the thicker ring-shaped feature, and in some embodiments, both ring-shaped features may be the same thickness. Referring also to Figure 5F, there is shown a cross section of the assembled plunger of the embodiment shown in Figures 5B-5E. Plunger seal 506 fits around plunger 504, and plunger cap 508 snaps over plunger seal 506. Referring now to Figures 5G-5P, various embodiments of plunger seal 506 are shown, as described above.

[0137] As described above, the plunger rod is connected to the plunger and is part of the reservoir assembly. The reservoir, as discussed above, functions to carry a volume of liquid for delivery by the infusion pump assembly. It is preferable to fill the reservoir with a liquid, e.g., insulin, before loading the reservoir assembly into the pump assembly. Thus, in implementation, a user loads the reservoir with insulin (or another liquid as discussed herein), attaches a locking hub (although in exemplary embodiments, as discussed above, the locking hub may be integral with the reservoir), and loads the reservoir assembly with the locking hub into the pump assembly.

[0138] In exemplary embodiments, the plunger rod is designed to engage and be driven by the drive screw as shown herein. Therefore, it may be difficult for some users to load the reservoir from a vial of insulin because the plunger rod is designed for drive screw engagement, not necessarily for engagement by a human finger. Therefore, in some embodiments, a filling aid may be desirable.

[0139] 6A-6D , an exemplary embodiment of a reservoir filling aid 600 is shown. In this embodiment, the filling aid 600 is designed to engage the threaded portion of the plunger rod 310, as described above; i.e., the filling aid includes a mating threaded portion 602. The filling aid 600 slides onto the plunger rod 310, and as the mating threaded portion 602 engages the plunger rod threads 320, the filling aid 600 is securely fastened to the plunger rod 310. A handle 604, in the exemplary embodiment, is shaped to accommodate a user's finger and serves as a pull tab. In practice, a user loads the reservoir by pulling back on the handle 604. Once the user has filled the reservoir, the filling aid 600 may be easily removed from the plunger rod by moving the filling aid 600 so that its threads disengage from the plunger rod threads. Filling aid 600, in the exemplary embodiment, is designed with tolerances so that the threads of the plunger rod are not damaged during the filling process. In various embodiments, the filling aid may be a different shape, for example, larger, or the handle may be shaped differently to accommodate users with arthritis or other ailments that may prevent them from easily utilizing the filling aid as shown. Alternative embodiments are shown in FIGS. 6E-6F. In the exemplary embodiment, filling aid 600 is made of plastic; however, in other embodiments, filling aid 600 may be made of any material, including, but not limited to, stainless steel or aluminum.

[0140] 6G-6I, in some embodiments, fill aid 606 may be connected to plunger rod 301 via plastic part 608. In these embodiments, plastic part 608 is manufactured such that fill aid 606 may be removed from plunger rod 310 by bending the plastic part, i.e., fill aid 606 breaks off from plunger rod 310. While fill aid 606 in these figures is shown having a particular shape, in other embodiments, the shape may be any of the other fill aid embodiments shown herein or other shapes that may be designed as discussed above. In some of the "break-off" embodiments of the fill aid, fill aid 606 and plastic part 608 may be molded together with plunger rod 310.

[0141] 7A-7B, pump assembly 100 is shown. Referring to FIGS. 1A-1B, pump assembly 100 includes a housing that, in an exemplary embodiment, is made of aluminum, plastic, and rubber sections. However, in various embodiments, the materials and sections are different and include, but are not limited to, rubber, aluminum, plastic, stainless steel, and any other suitable material. In an exemplary embodiment, the back surface of the housing shown in FIG. 1B includes a contour.

[0142] 7A-7B, portions of the housing have been removed. The switch assembly / input device and user interface screen have been removed. The pump barrel 312 is shown with the reservoir 306 inside. The battery compartment 706 is shown in FIG. 7A, and the pump assembly 100 is shown without the battery compartment 706 in FIG. 7B. Various features of the battery compartment 706 are described herein. The gearbox 364 is shown assembled with the pump housing 360 in the pump assembly 100. A hub and battery end cap 404 is shown assembled onto the pump assembly 100 .

[0143] 7C-7D, reservoir assembly 302 is shown engaged with drive screw 314 and in contact with strain gauge 708. As described in more detail herein, strain gauge 708 is in contact with drive screw 314. Pressure measurements of strain gauge 708 are obtained by electrical contacts 710. Strain gauge 708 measures the pressure exerted by drive screw 314. If drive screw 314 is unable to drive plunger rod 310 further into the reservoir, as methods for sensing occlusion are described in more detail herein, drive screw 314 will exert pressure onto strain gauge 708.

[0144] 7E, an embodiment of an optical sensor is shown. Optical sensors, such as those used in some embodiments of infusion pump devices, as described above and in more detail in U.S. Patent Application Publication No. US 2004 / 0135078 A1, published July 15, 2004, entitled "Optical Displacement Sensor for Infusion Devices," are used to determine whether plunger rod 310 has moved and / or advanced, and may also determine whether plunger rod 310 has moved and / or advanced the intended distance. Thus, in the infusion pump systems and devices described herein, the pump devices can use occlusion detection methods and devices to determine whether the drive screw is unable to advance, and also to determine whether the plunger rod has moved and the distance it has moved.

[0145] 8A-8D, an alternative embodiment of the reservoir assembly is shown. While the embodiments discussed and described above may be used in pumping assemblies, and in some embodiments, in the pumping assemblies shown and described herein, in other embodiments, the shape and size of the pumping assembly may differ from those shown herein. For example, the pump assembly may be round or smaller in shape. Therefore, it may be beneficial for the reservoir assembly to accommodate smaller or rounded shapes without having to sacrifice overall capacity. Exemplary embodiments of reservoir assemblies for these alternative embodiments are shown in FIGS. 8A-8C . However, it should be understood that these are merely examples. Depending on the size and shape of the pump assembly, the reservoir assemblies for alternative embodiments may be larger, smaller, or include larger or smaller angles.

[0146] 8A, a curved reservoir assembly 800 is shown. In various embodiments, the angle shown may have a value greater than or less than 180 degrees. In one exemplary embodiment, reservoir assembly 800 may have an angle of 150 degrees. In some embodiments, reservoir assembly 800 may form a helical shape. In other embodiments, reservoir assembly 800 may have any desired shape, including having one or more rounded or curved portions and / or one or more straight or nearly straight portions.

[0147] 8B-8D, another embodiment of an alternative embodiment reservoir assembly is shown. In this embodiment, the reservoir 802 and plunger rod 804 assembly is shown as having a round or near-round shape. The reservoir 802, in some embodiments, may be a channel within a housing 806, as shown in FIGS. 8B-8D. The reservoir 802 may be cylindrical, and the ends 808, 810 of the plunger 804 may be circular, while the plunger 804 may be flat 804 as shown. In various embodiments, the plunger 804 may be advanced by applying pressure to the end 808 of the plunger 804 by a mechanical feature (not shown), which may be located in the center 812 of the housing 806 in some embodiments, or elsewhere within the pump assembly within engageable proximity to the plunger rod 804 in other embodiments. In some embodiments, the reservoir 802 may be filled with liquid using an inlet 814.

[0148] As discussed above, enclosure assembly 102 may include injection port assembly 112 to which cannula assembly 114 may be releasably coupled. A portion of injection port assembly 112 and a portion of cannula assembly 114 may form a media connector assembly for releasably coupling injection port assembly 112 to cannula assembly 114 and achieving delivery of infusible fluid 200 to user 202.

[0149] 9A, one exemplary embodiment of a media connector assembly 900 for connecting media-carrying components (not shown) and enabling media flow therebetween is shown. Examples of media-carrying components may include, but are not limited to, a delivery catheter and an insulin delivery pump, a fluid supply (intravenous fluid supply bag, dialysate supply, etc.) and a pump supply catheter, or the like. The connector assembly 900 may include a media connector 902 associated with a first media-carrying component (not shown) and a mating connector 904 associated with a second media-carrying component.

[0150] The media connector 902 may include a passageway 906 to allow for the flow of media. For example, the media flowing between the media-carrying components via the passageway 906 may include a liquid (e.g., insulin, dialysate, saline, or the like), a gas (e.g., air, oxygen, nitrogen, or the like), a suspension, or the like. Additionally, the media connector 902 may include a multi-portion engagement surface 908 disposed generally about the periphery of the passageway 906. The multi-portion engagement surface 908 may include a first surface portion 910 and a second surface portion 912.

[0151] As discussed in further detail below, a first surface portion 910 of the multi-part engagement surface 908 may be configured to provide an interference fit with a corresponding sealing surface 914 of the mating connector 904. Additionally, a second surface portion 912 of the multi-part engagement surface 908 may be configured to provide a clearance fit with a corresponding sealing surface 914 of the mating connector 904. The ratio of the first surface portion 910 to the second surface portion 912 may be selected to adjust the engagement force between the medium connector 902 and the mating connector 904.

[0152] For example, the corresponding sealing surface 914 of the mating connector 904 may include a tapered surface that may include, for example, a 6% taper (e.g., an approximately 3.4 degree included taper) of a standard Luer taper connector (e.g., as defined by the ISO 594 standard). Of course, the corresponding sealing surface 914 may include a taper other than a 6% Luer taper. The multi-portion engaging surface 908 may similarly include a tapered surface where the first surface portion 910 may have a first taper angle and the second surface portion 912 may have a second taper angle that is less than the first taper angle. In one particular embodiment, the second taper angle may approach zero such that the second surface portion 912 may be generally cylindrical (e.g., may include a slight taper, such as a draft angle, to facilitate manufacturing). Of course, the second surface portion 912 may include other, non-cylindrical taper angles.

[0153] Continuing with the above example, a first surface portion 910 of the multi-portion engagement surface 908 may include a first taper angle (e.g., a 6% taper) that corresponds to the angle of a corresponding sealing surface 914 of the mating connector 904. As shown in FIG. 9B , the corresponding taper of the first surface portion 910 may provide an interference fit with the corresponding sealing surface 914 of the mating connector 904. Also, as shown, the second taper angle of the second surface portion 912 may provide a clearance fit with the corresponding sealing surface 914 of the mating connector 904, which may result in at least a partial gap 916 between the second surface portion 912 and the corresponding sealing surface 914, for example.

[0154] The contact surface area of ​​the medium connector 902 and the mating connector 904 may remain substantially constant once the first surface portion 910 engages the corresponding sealing surface 914 . For example, the first surface portion 910 may be configured to provide an interference fit with the corresponding sealing surface 914, while the second surface portion 912 of the multi-portion engagement surface 908 may be configured to provide a clearance fit with the corresponding sealing surface 914, such that only the first surface portion 910 may engage the corresponding sealing surface 914.

[0155] Once the first surface portion 910 engages the corresponding sealing surface 914, further insertion of the medium connector 902 into the mating connector 904 may be due to elastic and / or plastic deformation forces of the medium connector 902 in the area of ​​the first surface portion 910 and / or the mating connector 904 in the area of ​​contact between the corresponding sealing surface 914 and the first surface portion 910 (e.g., the first surface portion 910 is forced into the increasingly smaller opening provided by the corresponding sealing surface 914), as well as frictional interaction between the first surface portion 910 and the corresponding sealing surface 914 of the mating connector 904.

[0156] As such, the ratio of the first surface portion 910 to the second surface portion 912 may be selected to adjust the engagement force between the medium connector 902 and the mating connector 904. As discussed above, the second surface portion 912 may be configured to provide a clearance fit with the corresponding sealing surface 914, and as such, may not contribute to the engagement force (e.g., insertion force per increment of axial insertion) between the medium connector 902 and the mating connector 904. Thus, the ratio of the first surface portion 910 to the second surface portion 912 may be increased to increase the engagement force between the medium connector 902 and the mating connector 904. Conversely, the ratio of the first surface portion 910 to the second surface portion 912 may be decreased to decrease the engagement force between the medium connector 902 and the mating connector 904.

[0157] The ability to adjust the engagement force between the media connector 902 and the mating connector 904 (e.g., based on the ratio of the first surface portion 910 and the second surface portion 912) may enable the use of features associated with the media connector 902 (and / or the first associated media carrying component) and / or the mating connector 904 (and / or the second associated media carrying component) that may require a minimum insertion depth, since that is achieved within a selected range of insertion forces. For example, the media connector 902 may include one or more retention features that may promote positive engagement and / or relative positioning between the media connector 902 and the mating connector 904, for example. As shown in FIGS. 9A-9B , the one or more retention features may include one or more snap-fit ​​features (e.g., cooperating snap-fit ​​features 918, 920A associated with the media connector 902 and the mating connector 904, respectively). As shown, one or more of the cooperating snap-fit ​​features 918, 920A may be disposed on a cantilever feature (e.g., a cantilever arm 922), which may, for example, facilitate engagement / disengagement of the cooperating snap-fit ​​features 918, 920A. The snap-fit ​​features 918, 920A may require a minimum insertion depth to provide engagement therebetween. As described above, the ratio of the first surface portion 910 and the second surface portion 912 may be selected to adjust the engagement force between the medium connector 902 and the mating connector 904, which is associated with the insertion depth required to provide engagement between the snap-fit ​​features 918, 920A. While adjusting the engagement force between the medium connector and the mating connector is described in connection with the use of retention features, this is not intended as a limitation of the present disclosure, as the ability to adjust the engagement force between the medium connector and the mating connector may equally be used for other purposes.

[0158] 9C and 9D , a media connector assembly may include a media connector 902 associated with a first media-carrying component (not shown) and a mating connector 904 associated with a second media-carrying component. As shown, one or more of the cooperating snap-fit ​​features (e.g., cooperating snap-fit ​​features 918, 920B) may be provided as features associated with one of the mating surfaces of the media connector assembly (e.g., snap-fit ​​feature 920B may be formed on member 924 defining corresponding sealing surface 914). Based, at least in part, on the illustrated exemplary embodiments of FIGS. 9A-9B and 9C-9D , various additional / alternative arrangements may be readily understood and are contemplated by the present disclosure.

[0159] In addition to or as an alternative to the second surface portion including the second taper angle, the second surface portion may include one or more recesses. For example, referring also to FIG. 9E , the second surface portion may include one or more recesses including, for example, one or more longitudinal slots (e.g., longitudinal slot 950) that may be formed in the first surface portion 910. The longitudinal slot 950 may be configured to provide a clearance fit with the co-sealing surface 114 of the mating connector 904. For example, the longitudinal slot 950 may provide a second surface portion that may not engage the co-sealing surface 914 when the first surface portion 910 is fully engaged with the co-sealing surface 914 of the mating connector 904. The ratio of the first surface portion 910 to the longitudinal slot (e.g., longitudinal slot 950) may be selected to adjust the engagement force between the medium connector 902 and the mating connector 904, for example, to the extent that the longitudinal slot 950 does not have to provide a frictional engagement force with the co-sealing surface 914 of the mating connector 904.

[0160] 9F , additionally / alternatively, the second surface portion may include one or more radial slots (e.g., radial slot 952) or may include one or more recesses. Similar to the longitudinal slots (e.g., longitudinal slot 950) described above, the radial slots 952 may be configured to provide a clearance fit with the corresponding sealing surface 914 of the mating connector 904. As such, the ratio of the first surface portion 910 to the radial slots (e.g., radial slot 952) may be selected to adjust the engagement force between the medium connector 902 and the mating connector 904. For example, the radial slots 952 may not provide a frictional engagement force with the cooperating sealing surface 914 of the mating connector 904.

[0161] In addition to the specifically described and depicted recesses, which are in the form of longitudinal and radial slots, one or more recesses may include various additional and / or alternative configurations (e.g., indentations, etc.) that may be configured to provide a clearance fit with the cooperating sealing surface of the mating connector. As such, the ratio of the first surface portion to the second surface portion (including the one or more recesses) may be selected to adjust the engagement force between the medium connector and the mating connector. Furthermore, it will be recognized that the number, arrangement, and characteristics of the one or more recesses may vary according to design criteria and preferences.

[0162] While the above embodiment is depicted having a multi-portion engagement surface configured as a male medium connector portion, referring also to FIGS. 9G-9H , the medium connector 902 may additionally / alternatively be configured as a female connector portion. For example, the medium connector 902 may include a female connector portion having a multi-portion engagement surface including a first surface portion 910 and a second surface portion 912. As shown in FIG. 9G , the multi-portion engagement surface may include a tapered surface, where the first surface portion 910 may have a first taper angle configured to provide an interference fit with the cooperating sealing surface 914 of the male mating connector 904. Additionally, the second surface portion 912 may have a second taper angle that is greater than the first taper angle. As such, the second surface portion 912 may be configured to provide a clearance fit with the cooperating sealing surface 914 of the male mating connector 904.

[0163] Further, the second surface portion may include one or more recesses. For example, and referring also to FIGS. 9H-9I , the one or more recesses may include one or more longitudinal slots (e.g., longitudinal slots 950A, 950B). Similar to previously described embodiments, the first surface portion 910 may be configured to provide an interference fit with the cooperating sealing surface 914 of the male mating connector 904. Further, the second surface portion, including the longitudinal slots 950A, 950B, may be configured to provide a clearance fit with the cooperating sealing surface 914 of the male mating connector 904. The medium connector 902 may include a sealing region 954, which may not include a longitudinal slot, for example, to facilitate achieving a seal between the first surface portion 910 and the cooperating sealing surface 914 of the male mating connector 904.

[0164] 9J , the second surface portion may include one or more recesses, which may include one or more radial slots, such as radial slot 952. Radial slot 952 may be configured to provide a clearance fit with cooperating sealing surface 914 of male mating connector 904.

[0165] In addition to the specifically described and depicted recesses in the form of longitudinal and radial slots, one or more recesses may include various additional and / or alternative configurations (e.g., indentations, etc.) that may be configured to provide a clearance fit with the co-sealing surface of the mating connector. As such, the ratio of the first surface portion to the second surface portion (including the one or more recesses) may be selected to adjust the engagement force between the medium connector and the mating connector. Furthermore, it will be recognized that the number, arrangement, and characteristics of the one or more recesses may vary according to design criteria and preferences.

[0166] As discussed above, infusion pump assembly 100 may include removable cover assembly 116 configured to allow access to power supply cavity 118 (shown in phantom in FIG. 2).

[0167] 10A-10C , power supply cavity 118 (which may be formed by the combination of removable cover assembly 116 and a portion of enclosure assembly 102) may be configured to releasably receive primary power supply 220. Additionally, power supply cavity 118 may be configured to prevent primary power supply 220 from being electrically coupled to processing logic 204 in reverse polarity. For example, power supply cavity 118 may be configured to prevent positive terminal 1000 of primary power supply 220 from being electrically coupled to negative terminal 1002 of power supply cavity 118 and / or negative terminal 1004 of primary power supply 220 from being electrically coupled to positive terminal 1006 of power supply cavity 118.

[0168] Configuring power supply cavity 118 to prevent primary power supply 220 from being electrically coupled to processing logic 204 in reverse polarity may provide various benefits. For example, the configuration may prevent loss of power from primary power supply 220 (e.g., battery discharge) if primary power supply assembly 220 is inserted incorrectly. In addition to serving to conserve power, this configuration may also be a safety feature for infusion pump assembly 100. Infusion pump assembly 100 may rely on power for functionality. A user may rely on infusion pump assembly 100 to provide life-sustaining therapy, for example, by delivering insulin. Thus, preventing primary power supply 220 from being electrically coupled to processing logic 204 in reverse polarity (e.g., as a result of user 202 accidentally inserting primary power supply 220 incorrectly) may allow infusion pump assembly 100 to function for a longer period of time than if an incorrectly installed primary power supply 220 were allowed to be electrically coupled to processing logic 204 in reverse polarity.

[0169] The removable cover assembly 116 may be configured to allow access to the power supply cavity 118 to accomplish installation / replacement / removal of the primary power supply 220. As discussed above, embodiments of the primary power supply 220 may include, but are not limited to, a battery. In some embodiments, the battery may include, but is not limited to, a D, C, AA, or AAA battery, and the battery may be a lithium battery or an alkaline battery. The battery may, in some embodiments, be a rechargeable battery.

[0170] Removable cover assembly 116 may be configured to rotatably engage enclosure assembly 102 in the direction of arrow 1008. For example, removable cover assembly 116 may include a first twist lock assembly 1010 (e.g., a protruding tab). Enclosure assembly 102 may include a second twist lock assembly 1012 (e.g., a slot) configured to releasably engage the first twist lock assembly to achieve releasable engagement of the removable cover assembly and the enclosure assembly.

[0171] While removable cover assembly 116 and enclosure assembly 102 are described above as including first and second twist lock assemblies 1010 and 1012, this is for illustrative purposes only and is not intended to be a limitation of the present disclosure, as other configurations are possible and are considered within the scope of the present disclosure. For example, one or more thread assemblies (not shown) may be utilized to achieve the above-described rotatable engagement.

[0172] Additionally, while removable cover assembly 116 is described above as being configured to rotatably engage enclosure assembly 102, this is for illustrative purposes only and is not intended to be a limitation of the present disclosure, as other configurations are possible. For example, removable cover assembly 116 may be configured to slidably engage enclosure assembly 102 (in the direction of arrow 1014) using a slide assembly (not shown). Alternatively, removable cover assembly 116 may be configured to be pushed into enclosure assembly 102 in the direction of arrow 1016.

[0173] The removable cover assembly 116 may include a sealing assembly 1018 (e.g., an O-ring assembly) configured to releasably engage at least a portion of the enclosure assembly 102 to form an essentially watertight seal between the removable cover assembly 116 and the enclosure assembly 102.

[0174] In embodiments in which the sealing assembly 1018 includes an O-ring assembly contained within the removable cover assembly 116, the O-ring assembly may be sized to achieve a watertight (or essentially watertight) seal with a corresponding surface of the enclosure assembly 102.

[0175] Alternatively, in embodiments in which the sealing assembly 1018 includes an O-ring assembly contained within the enclosure assembly 102, the O-ring assembly may be sized to achieve a watertight (or essentially watertight) seal with a corresponding surface of the removable cover assembly 116.

[0176] Removable cover assembly 116 may include a conductor assembly 1020 for electrically coupling positive terminal 1006 of removable cover assembly 116 with inner wall 120 of power supply cavity 118 ( FIG. 1D ). For example, conductor assembly 1020 may include a plurality of tabs (e.g., tabs 1022, 1024) that may be electrically coupled to positive terminal 1006 of removable cover assembly 116. Tabs 1022, 1024 may be configured such that tabs 1022, 1024 may be in electrical contact with inner wall 120 of power supply cavity 118 when removable cover assembly 116 releasably engages enclosure assembly 102. Inner wall 120 of power supply cavity 118 may then be electrically coupled to various components within infusion pump assembly 100 requiring electrical power, examples of which may include, but are not limited to, processing logic 204.

[0177] As discussed above, the combination of removable cover assembly 116 and a portion of enclosure assembly 102 may be configured to prevent primary power supply 220 from being electrically coupled in reverse polarity to processing logic 204, for example. Referring also to FIG. 11 , one or more of negative terminal 1002 and positive terminal 1006 may be configured to prevent the above-described reverse polarity situation from occurring. For example, removable cover assembly 116 may include an insulator assembly 1026 including a recess 1028 sized to receive positive terminal 1000 of primary power supply 220 and allow electrical contact with positive terminal 1006 of removable cover assembly 116. Insulator assembly 1026 may be constructed of an insulating material, such as PVC plastic or Bakelite. Furthermore, the recess 1028 may be sized such that the negative terminal 1004 of the primary power supply 220 cannot make electrical contact with the positive terminal 1006 (and may only be in contact with the insulator 1026), thus preventing the primary power supply 220 from being electrically coupled to the processing logic 204 in a reverse polarity configuration.

[0178] 12A-12D, an alternative embodiment removable cover assembly 116′ is shown. The removable cover assembly 116′ may include a sealing assembly 1018′ (e.g., an O-ring assembly) configured to releasably engage at least a portion of the enclosure assembly 102 to form an essentially watertight seal between the removable cover assembly 116′ and the enclosure assembly 102.

[0179] The removable cover assembly 116' may include a conductor assembly 1020' for electrically coupling the positive terminal 1006' of the removable cover assembly 116' with the inner wall 120 ( FIG. 1D ) of the power supply cavity 118. For example, the conductor assembly 1020' may include multiple tabs (e.g., tabs 1022', 1024') that may be electrically coupled to the positive terminal 1006' of the removable cover assembly 116'. The tabs 1022', 1024' may be configured such that the tabs 1022', 1024' may be in electrical contact with the inner wall 120 of the power supply cavity 118 when the removable cover assembly 116' is releasably engaged with the enclosure assembly 102. The inner wall 120 of the power supply cavity 118 may then be electrically coupled to various components within the injection pump assembly 100 that require power, examples of which may include, but are not limited to, processing logic 204.

[0180] As discussed above, the combination of removable cover assembly 116' and a portion of enclosure assembly 102 may be configured to prevent primary power supply 220 from being electrically coupled to processing logic 204 in reverse polarity. For example, removable cover assembly 116' may include an insulator assembly 1026' that defines a recess 1028' sized to receive positive terminal 1000 ( FIG. 11 ) of primary power supply 220 ( FIG. 11 ) and allow electrical contact with positive terminal 1006' of removable cover assembly 116'. Insulator assembly 1026', which may be constructed of an insulating material (e.g., PVC plastic or Bakelite), may be molded into and / or be a part of removable cover assembly 116'. Furthermore, the recess 1028′ may be sized such that the negative terminal 1004 (FIG. 11) of the primary power supply 220 cannot make electrical contact with the positive terminal 1006′ (and may only be in contact with the insulator 1026′), thus preventing the primary power supply 220 from being electrically coupled to the processing logic 204 in a reverse polarity configuration.

[0181] Although power delivery cavity 118 is described above as having positive terminal 1006 located proximate removable cover assembly 116, this is for illustrative purposes only and is not intended to be a limitation of the present disclosure, as other configurations are possible and are considered within the scope of the present disclosure. For example, negative terminal 1002 may be located proximate removable cover assembly 116.

[0182] 12E-12P, another embodiment of a removable cover assembly is shown. The removable cover assembly 12200 may include a conductor assembly 12202 for electrically coupling a positive terminal 12204 of the removable cover assembly 12200 with the inner wall 120 (FIG. 1D) of the power supply cavity 118 (FIG. 1D). For example, the conductor assembly 12202 may include multiple tabs (e.g., tabs 12206, 12208) that may be electrically coupled to the positive terminal 12204 of the removable cover assembly 12200. The tabs 12206, 12208 may be configured such that the tabs 12206, 12208 may be in electrical contact with the inner wall 114 of the power supply cavity 112 when the removable cover assembly 12200 is releasably engaged with the enclosure assembly 102 (FIG. 1D). The inner wall 114 of the power supply cavity 112 may then be electrically coupled to various components within the injection pump assembly 100 that require power, examples of which may include, but are not limited to, processing logic 204.

[0183] As discussed above, the combination of the removable cover assembly 12200 and a portion of the enclosure assembly 102 may be configured to prevent the removable power supply assembly 220 from being electrically coupled to the processing logic 204 with reverse polarity. For example, the removable cover assembly 12200 may include a power supply interface assembly 12210 defining an opening 12212 sized to receive the positive terminal 150 ( FIG. 11 ) of the removable power supply assembly 36 and allow electrical contact with the positive terminal 12204 of the removable cover assembly 12200 via the spring assembly 12214. In an exemplary embodiment, the power supply interface assembly 12210 is made of a non-conductive material and the spring assembly 12214 is made of a conductive material. The power supply interface assembly 12210 may be constructed of an insulating material (which in some embodiments may include, but is not limited to, a plastic, which may include, but is not limited to, PVC plastic or Bakelite). Additionally, the opening 12212 may be sized so that the positive terminal 1000 ( FIG. 11 ) of the removable power supply assembly 220 is received by and aligned with the opening 12212 of the power supply interface assembly 210. Once the positive terminal 1000 ( FIG. 11 ) of the removable power supply assembly 220 is received by and aligned with the opening 12212 of the power supply interface assembly 12210, the spring assembly 12214 provides an electrical connection between the positive terminal 1000 of the removable power assembly 220 and the positive terminal 12204 of the removable cover assembly 12200.

[0184] In this embodiment of the removable cover assembly 12200, the electrical coupling between the positive terminal 1000 of the removable power assembly 220 and the positive terminal 12204 of the removable cover assembly 12200 may be maintained via the spring assembly 12214. This embodiment may be desirable to prevent decoupling between the positive terminal 1000 of the removable power assembly 220 and the positive terminal 12204 of the removable cover assembly 12200 during such conditions that may create a decoupling force.

[0185] While power delivery cavity 118 is described above as having positive terminal 1006 located proximate removable cover assembly 12200, this is for illustrative purposes only and is not intended to be a limitation of the present disclosure, as other configurations are possible and are considered within the scope of the present disclosure. For example, negative terminal 1002 may be located proximate removable cover assembly 116.

[0186] The removable cover assembly 12200 may include a sealing assembly 12216 (e.g., an O-ring assembly) configured to releasably engage at least a portion of the enclosure assembly 102 to form an essentially watertight seal between the removable cover assembly 12200 and the enclosure assembly 102. However, in other embodiments, various other or additional means for sealing the power supply cavity 118 may be used.

[0187] In embodiments in which the sealing assembly 12216 includes an O-ring assembly contained within the removable cover assembly 12200, the O-ring assembly may be sized to achieve a watertight (or essentially watertight) seal with a corresponding surface of the enclosure assembly 102.

[0188] Alternatively, in embodiments in which the sealing assembly 12216 includes an O-ring assembly contained within the enclosure assembly 102, the O-ring assembly may be sized to achieve a watertight (or essentially watertight) seal with a corresponding surface of the removable cover assembly 12200.

[0189] 12K-12P, another embodiment of a removable cover assembly is shown. The removable cover assembly 12200′ may include a conductor assembly 12202′ for electrically coupling a positive terminal 12204′ of the removable cover assembly 12200′ with the inner wall 114 ( FIG. 1D ) of the power supply cavity 112 ( FIG. 1D ). For example, the conductor assembly 12202′ may include multiple tabs (e.g., tabs 12206′, 12208′) that may be electrically coupled to the positive terminal 12204′ of the removable cover assembly 12200′. Tabs 12206', 12208' may be configured such that when removable cover assembly 12200' releasably engages enclosure assembly 102 (FIG. 1D), tabs 12206', 12208' may be in electrical contact with inner wall 114 of power supply cavity 112. Inner wall 114 of power supply cavity 112 may then be electrically coupled to various components within infusion pump assembly 100 that require electrical power, examples of which may include, but are not limited to, processing logic 204.

[0190] As discussed above, the combination of removable cover assembly 12200′ and a portion of enclosure assembly 102 may be configured to prevent removable power supply assembly 220 from being electrically coupled to processing logic 204 with reverse polarity. For example, removable cover assembly 200′ may include a power supply interface assembly 12210′ that defines an opening 12212′ sized to receive positive terminal 1000 ( FIG. 11 ) of removable power supply assembly 220 and allow electrical contact with positive terminal 12204′ of removable cover assembly 12200′ via spring assembly 12214′. In an exemplary embodiment, power supply interface assembly 12210′ is made of a non-conductive material and spring assembly 12214′ is made of a conductive material. The power supply interface assembly 12210′ may be constructed of an insulating material (which in some embodiments may include, but is not limited to, a plastic, which may include, but is not limited to, PVC plastic or Bakelite). Further, the opening 12212′ may be sized such that the positive terminal 1000 ( FIG. 11 ) of the removable power supply assembly 220 is received by and aligned with the opening 12212′ of the power supply interface assembly 12210′. Once the positive terminal 1000 ( FIG. 11 ) of the removable power supply assembly 220 is received by and aligned with the opening 12212′ of the power supply interface assembly 12210′, the spring assembly 12214′ provides electrical coupling between the negative terminal 1004 of the removable power assembly 220 and the positive terminal 12204′ of the removable cover assembly 12200′.

[0191] In this embodiment of the removable cover assembly 12200', the electrical connection between the negative terminal 1004 of the removable power assembly 220 and the positive terminal 12204' of the removable cover assembly 12200' may be maintained via a spring assembly 12214'. This embodiment may be desirable to prevent decoupling between negative terminal 1004 of removable power assembly 220 and positive terminal 12204' of removable cover assembly 12200 during such conditions that may create decoupling forces.

[0192] While the power delivery cavity 12212 is described above as having the positive terminal 1000 located proximate the removable cover assembly 12200′, this is for illustrative purposes only and is not intended to be a limitation of the present disclosure, as other configurations are possible and are considered within the scope of the present disclosure. For example, the negative terminal 1004 may be located proximate the removable cover assembly 12200′.

[0193] The removable cover assembly 12200′ may include a sealing assembly 12216′ (e.g., an O-ring assembly) configured to releasably engage at least a portion of the enclosure assembly 102 to form an essentially watertight seal between the removable cover assembly 200′ and the enclosure assembly 102. However, in other embodiments, various other or additional means for sealing the power supply cavity 112 may be used.

[0194] In embodiments in which the sealing assembly 12216′ includes an O-ring assembly contained within the removable cover assembly 12200′, the O-ring assembly may be sized to achieve a watertight (or essentially watertight) seal with a corresponding surface of the enclosure assembly 102.

[0195] Alternatively, in embodiments in which the sealing assembly 12216′ includes an O-ring assembly contained within the enclosure assembly 102, the O-ring assembly may be sized to achieve a watertight (or essentially watertight) seal with a corresponding surface of the removable cover assembly 110.

[0196] 12E-12P discussed above, the power supply interface assembly 12210, 12210' includes geometries that may be beneficial in maintaining alignment of the power supply assembly 220. With respect to the power supply interface assembly 12210 shown in FIGS. 12E-12J, the geometries may be different than those found in the power supply interface assembly 12210' shown in FIGS. 12K-12P. The two geometric embodiments shown herein are exemplary embodiments, and other geometries may be used in other embodiments.

[0197] The above-described embodiments of the removable cover assembly may be used in conjunction with any device, including, but not limited to, an infusion pump device, including, but not limited to, an insulin pump. In some embodiments, the removable cover assembly may be used with any of the infusion pumps described herein. In other embodiments, the removable cover assembly, or an assembly similar to those described herein, may be used with, for example, any portable medical device or any other infusion pump. It will be understood that the sizes shown are exemplary embodiments only, and that in various embodiments, the sizes may vary. Additionally, it will be understood that the geometries shown are exemplary embodiments only, and that in various embodiments, the geometries may vary.

[0198] 13, a more detailed diagram of the processing logic 204 is shown. The processing logic 204 may include one or more circuit partitioning components 1300, 1302 configured to partition the processing logic 204 into primary processing logic 1304 and backup processing logic 1306. Embodiments of the one or more circuit partitioning components 1300, 1302 may include, but are not limited to, a diode assembly 1300 and a current limiting assembly 1302.

[0199] The diode assembly 1300 may be configured to allow the primary power supply 220 to charge the backup power supply 1308 included within the backup processing logic 1306 while prohibiting the backup power supply 1308 from providing backup electrical energy 1310 to the primary processing logic 1304 in the event that some form of fault prevents the primary electrical energy 1312 from being provided to the primary processing logic 1304. Examples of the backup power supply 1308 may include, but are not limited to, a supercapacitor assembly. Examples of such supercapacitor assemblies may include, but are not limited to, electric double layer capacitors manufactured by Elna Co. Ltd. (Yokohama, Japan).

[0200] The current limiting assembly 1302 may be configured to limit the amount of primary electrical energy 1312 available to charge the backup power supply 1308. Specifically, as the primary power supply 220 may be configured to charge the backup power supply 1308, the amount of current available from the primary power supply 220 may be limited to avoid, for example, depriving the primary processing logic 1304 of a needed portion of the primary electrical energy 1312.

[0201] The primary processing logic 1304 may include a primary microprocessor 1314 and a voltage booster circuit 1316. An example of the primary microprocessor 1314 may include, but is not limited to, the H8S / 2000 manufactured by Renesas Technology America Inc. (San Jose, CA). The voltage booster circuit 1316 may be configured to increase the voltage potential of the primary electrical energy 1312 provided by the primary power supply 220 to a level sufficient to power the primary microprocessor 1314. An example of the voltage booster circuit 1316 may include, but is not limited to, the LTC3421 manufactured by Linear Technology (Milpitas, CA).

[0202] The current limiting assembly 1302 may be configured to limit the amount of current available to charge the backup power supply 1308 while the primary microprocessor 1314 is powered up. Specifically, by way of example, the current limiting assembly 1302 may be controlled by the primary microprocessor 1314, and the current limiting assembly 1302 may be disabled (i.e., not provide charging current to the backup power supply 1308) until after the primary microprocessor 1314 is fully powered up. Once the primary microprocessor 1314 is fully powered up, the primary microprocessor 1314 may enable the current limiting assembly 1302, thus providing charging current to the backup power supply 1308. Alternatively, when initially energized, the current limiting assembly 1302 may be configured to prohibit the flow of charging current to the backup power supply 1308 for a time sufficient to allow the primary microprocessor 1314 to power up.

[0203] The backup processing logic 1306 may include a backup power supply 1308 and a safety microprocessor 1318. Examples of the safety microprocessor 1318 include, but are not limited to, the MSP430 manufactured by Texas Instruments (Dallas, TX).

[0204] Primary power supply 220 may be configured to provide primary electrical energy 1312 to at least a portion of processing logic 204. Specifically, during normal operation of infusion pump assembly 100, primary power supply 220 may be configured to provide primary electrical energy 1312 to all of processing logic 204 (including various components of primary processing logic 1304 and backup processing logic 1306) as well as to various subsystems included within infusion pump assembly 100.

[0205] Examples of such subsystems may include, but are not limited to, a memory system 208 , an input system 206 , a display system 104 , a vibration system 210 , an audio system 212 , a motor assembly 214 , a force sensor 216 , and a displacement detection device 218 .

[0206] The backup power supply 1308 may be configured to provide backup electrical energy 1310 to at least a portion of the processing logic 204 in the event that the primary power supply 220 fails to provide primary electrical energy 1312 to at least a portion of the processing logic 204. Specifically, the backup power supply 1308 may be configured to provide backup electrical energy 1310 to the backup processing logic 1306 in the event that the primary power supply 220 fails and, therefore, can no longer provide primary electrical energy 1312 to the processing logic 204.

[0207] For illustrative purposes only, assume that infusion pump assembly 100 is operating normally and that primary power supply 220 is providing primary electrical energy 1312 to processing logic 204. As discussed above, voltage booster circuit 1316 may increase the voltage potential of primary electrical energy 1312 to a level sufficient to power primary microprocessor 1314, both of which are within primary processing logic 1304.

[0208] Additionally, the diode assembly 1300 may allow a portion of the primary electrical energy 1312 to enter the backup processing logic 1306, thus enabling operation of the safety microprocessor 1318 and charging of the backup power supply 1308. As discussed above, examples of the backup power supply 1308 may include, but are not limited to, a supercapacitor. As discussed above, the current limiting assembly 1302 may limit the amount of current provided by the primary power supply 220 to the backup processing logic 1306, thus preventing the shunting of an excessive portion of the primary electrical energy 1312 from the primary processing logic 1304 to the backup processing logic 1306.

[0209] Thus, in addition to powering the safety microprocessor 1318, the primary power supply 220 may also charge the backup power supply 1308. In a preferred embodiment, the backup power supply 1308 is a 0.33 Farad supercapacitor.

[0210] The safety microprocessor 1318 may monitor the status of the primary power supply 220 by monitoring (via conductor 1320) the voltage potential present at the input of the voltage booster circuit 1316. Alternatively, the safety microprocessor 1318 may monitor the status of the primary power supply 220, for example, by monitoring the voltage potential present at the output of the voltage booster circuit 1316. Still further, the safety microprocessor 1318 and the primary microprocessor 1314 may be electrically coupled, for example, via conductor 1322, and the primary microprocessor 1314 may be configured to continuously provide a “beacon” signal to the safety microprocessor 1318. The conductor 1322 may include an isolation circuit 1324 (e.g., one or more diode assemblies) to electrically isolate the safety microprocessor 1318 and the primary microprocessor 1314. Thus, if the safety microprocessor 1318 continues to receive a "beacon" signal from the primary microprocessor 1314, the primary microprocessor 1314 is functional and therefore being properly power shared by the primary power supply 220. If the safety microprocessor 1318 fails to receive a "beacon" signal from the primary microprocessor 1314, an alarm sequence may be initiated.

[0211] Still further, the safety microprocessor 1318 may be configured to continuously provide a "beacon" signal to the primary microprocessor 1314. Thus, if the primary microprocessor 1314 continues to receive a "beacon" signal from the safety microprocessor 1318, the safety microprocessor 1318 is functional and therefore being properly power shared by the backup power supply 1308. If the primary microprocessor 1314 fails to receive a "beacon" signal from the safety microprocessor 1318, an alarm sequence may be initiated.

[0212] As used in this disclosure, a "beacon" signal may be considered an event performed by the primary microprocessor 1314 (and / or the safety microprocessor 1318) solely for the purpose of announcing the presence of the primary microprocessor 1314 (and / or the safety microprocessor 1318). Additionally / alternatively, a "beacon" signal may be considered an event performed by the primary microprocessor 1314 (and / or the safety microprocessor 1318) for the purpose of performing a task, the execution of which is monitored by the safety microprocessor 1318 (and / or the primary microprocessor 1314) to confirm the presence of the primary microprocessor 1314 (and / or the safety microprocessor 1318).

[0213] For illustrative purposes, assume that primary power supply 220 fails. For example, assume that primary power supply 220 physically fails (as opposed to simply being discharged). Examples of such a failure may include, but are not limited to, failure of a battery (not shown) within primary power supply 220 and failure of a conductor (e.g., one or more of conductors 1320, 1326) electrically coupling primary power supply 220 to processing logic 204. Thus, in the event of such a failure, primary power supply 220 may no longer provide primary electrical energy 1312 to processing logic 204.

[0214] However, when such a failure of the primary power supply 220 occurs, the voltage potential present at the output of the voltage booster circuit 1316 and the voltage potential present at the input of the voltage booster circuit 1316 may be reduced to zero. Because the safety microprocessor 1318 may monitor one or more of these voltage potentials (as discussed above), the safety microprocessor 1318 may know that the primary power supply 220 has failed.

[0215] Furthermore, when such a failure of the primary power supply 220 occurs, the primary microprocessor 1314 will no longer be powered and, therefore, will no longer generate the "beacon" signal described above. Because the safety microprocessor 1318 monitors the "beacon" signal, the safety microprocessor 1318 will know that the primary power supply 220 has failed.

[0216] As discussed above, in the event of such a failure of the primary power supply 220, the backup power supply 1308 may not provide backup electrical energy 1310 to the primary processing logic 1304 because the diode assembly 1300 is reverse biased. Thus, the primary processing logic 1304 will no longer function.

[0217] Upon sensing a failure of the primary power supply 220, the safety microprocessor 1318 may initiate an alarm sequence that may energize the audio system 212. The audio system 212 may be controllable by both the safety microprocessor 1318 and the primary microprocessor 1314. Alternatively, separate audio systems may be used for each of the safety microprocessor 1318 and the primary microprocessor 1314. An example of the audio system 212 may include, but is not limited to, a piezoelectric diaphragm, an example of which may include, but is not limited to, a 7BB-15-6 manufactured by Murata (Kyoto, Japan).

[0218] The audio system 212 may further include an RS232 line driver circuit 1330, such as the MAX3319 / MAX3221 manufactured by Maxim Integrated Products (Sunnyvale, Calif.). One or more of the primary microprocessor 1314 and the safety microprocessor 1318 may be configured to provide an alarm control signal (e.g., a square wave, not shown) to the RS232 line driver circuit 1330 to generate an alarm output signal (not shown) that may be provided to and may drive the piezoelectric diaphragm described above.

[0219] The alarm sequence initiated by the safety microprocessor 1318 is intended to notify the user 202 of a failure of the primary power supply 220 so that the user 202 may take appropriate action (e.g., seek alternative means to deliver therapy and / or have the infusion pump assembly 100 repaired / replaced). The backup power supply 1308 may be sized so that the safety microprocessor 1318 and audio system 212 may continue to function for up to 15 minutes or more (i.e., depending on design specifications) after a failure of the primary power supply 220.

[0220] The alarm sequence initiated by the safety microprocessor 1318 and / or primary microprocessor 1314 may be an “escalating” alarm sequence. For example, a discrete “vibration” alarm may be initiated first (via the vibration system 210). If the “vibration” alarm is not acknowledged within a defined period (e.g., one minute), a low-volume audible alarm may be initiated. If the low-volume alarm is not acknowledged within a defined period (e.g., one minute), a medium-volume audible alarm may be initiated. If the medium-volume alarm is not acknowledged within a defined period (e.g., one minute), a high-volume audible alarm may be initiated. An escalating alarm sequence may provide a notification to the user 202, which may be discrete or less disruptive initially. A discrete or less disruptive notification initially may be advantageous so that the user 202 experiences minimal disruption. However, the escalating nature of the alarm may provide an additional layer of safety to the user 202 if the user 202 does not acknowledge the alarm. Additionally, in the event of an audio system 212 error or a vibration system 210 error, an escalating alert sequence, which may include both vibration and audio alerts, may ensure that the user 202 is notified regardless of whether both systems 210, 212 are functioning.

[0221] In some embodiments, audio system 212 may be configured to perform a self-test upon power-on. For example, when infusion pump assembly 100 is initially powered on, audio system 212 may provide a "beep-type" signal to each sound-generating device included within audio system 212. If user 202 does not hear these "beep-type" signals, user 202 may take appropriate action (e.g., seek alternative means to administer therapy and / or have infusion pump assembly 100 repaired / replaced). As discussed above, audio system 212 may be controllable by safety microprocessor 1318 and / or primary microprocessor 1314. Thus, when performing the above-described self-test upon power-on, safety microprocessor 1318 and / or primary microprocessor 1314 may control the above-described self-test. This feature may provide additional safety to user 202, as user 202 may be alerted to a system error earlier than would otherwise be the case. Also, the system may not otherwise recognize errors in the audio system 212, and therefore this feature provides for identification of faults by the user 202 that may otherwise go undetected.

[0222] During a failure of the primary power supply 220, the safety microprocessor 1318 may continue to monitor the voltage potential present at the output of the voltage booster circuit 1316 and / or the voltage potential present at the input of the voltage booster circuit 1316. In addition, the safety microprocessor 1318 may continue to monitor for the presence of the above-mentioned "beep-type" signal. Thus, if the failure of the primary power supply 220 was a temporary event (e.g., the primary power supply 220 had a dead battery and has been replaced with a new battery), the safety microprocessor 1318 may know when the primary power supply 220 is once again functioning properly.

[0223] Once the primary power supply 220 is once again functioning properly, the diode assembly 1300 and the current limiting assembly 1302 may allow a portion of the primary electrical energy 1312 generated by the primary power supply 220 to recharge the backup power supply 1308.

[0224] Additionally, safety microprocessor 1318 and primary microprocessor 1314 may each maintain a real-time clock so that various doses of infusible fluid can be dispensed at the appropriate times. Because primary microprocessor 1314 was not functioning during a failure of primary power supply 220, the real-time clock maintained within primary microprocessor 1314 may no longer be accurate. Therefore, the real-time clock maintained within safety microprocessor 1318 may be used to reset the real-time clock maintained within primary microprocessor 1314.

[0225] To further enhance the reliability and safety of infusion pump assembly 100, primary microprocessor 1314 and safety microprocessor 1318 may each execute applications written in different programming languages. For example, primary microprocessor 1314 may be configured to execute one or more primary applications written in a first computer language, while safety microprocessor 1318 may be configured to execute one or more safety applications written in a second computer language.

[0226] Examples of first computer languages ​​in which the primary application is written may include, but are not limited to, Ada, Basic, Cobol, C, C++, C#, Fortran, Visual Assembler, Visual Basic, Visual J++, Java, and Java Script languages. In a preferred embodiment, the first computer language in which the primary application (which runs on the primary microprocessor 1314) is written is the C++ computer language.

[0227] Examples of second computer languages ​​in which the security application may be written may include, but are not limited to, Ada, Basic, Cobol, C, C++, C#, Fortran, Visual Assembler, Visual Basic, Visual J++, Java, and Java Script languages. In a preferred embodiment, the second computer language in which secure applications (which run on the secure microprocessor 1318) are written is the C computer language.

[0228] Furthermore, assuming that the primary microprocessor 1314 and the secure microprocessor 1318 are different types of microprocessors and therefore use different compilers, the compiled code associated with the primary application executed by the primary microprocessor 1314 and the secure application executed by the secure microprocessor 1318 may be different (whether the primary application and the secure application are written in the same computer language).

[0229] Examples of the one or more primary applications written in a first computer language and executable on the primary microprocessor 1314 may include, but are not limited to, an operating system (e.g., Linux, Unix, Windows CE™), an executive loop, and various software applications. Additionally, examples of the one or more secure applications written in a second computer language and executable on the secure microprocessor 1318 may include, but are not limited to, an operating system (e.g., Linux, Unix, Windows CE™), an executive loop, and various software applications.

[0230] Thus, the primary processing logic 1304 and the backup processing logic 1306 may each be configured as separate, stand-alone, autonomous computing devices. Thus, the primary microprocessor 1314 included in the primary processing logic 1304 may execute a first operating system (e.g., Linux), and the secure microprocessor 1318 included in the backup processing logic 1306 may execute an executive loop.

[0231] Additionally, primary microprocessor 1314 included within primary processing logic 1304 may execute one or more software applications (e.g., a graphical user interface application, a scheduling application, a control application, a telemetry application) that may be executed within a Linux® operating system (in this example). Furthermore, secure microprocessor 1318 included within backup processing logic 1306 may execute one or more software applications (e.g., a graphical user interface application, a scheduling application, a control application, a telemetry application) that may be executed within an executive loop (in this example).

[0232] By utilizing multiple computer languages ​​and / or multiple operating systems, the infusion pump assembly may be less susceptible to, for example, computer language bugs, operating system bugs, and / or computer viruses.

[0233] One or more of the primary microprocessor 1314 (contained within the primary processing logic 1304 of the processing logic 204) and the secure microprocessor 1318 (contained within the backup processing logic 1306 of the processing logic 204) may perform the verification process 234 (FIG. 2). As discussed in more detail below, the verification process 234 may be configured to process commands received on a first microprocessor (e.g., primary microprocessor 1314) so ​​that the commands can be verified by a second microprocessor (e.g., safety microprocessor 1318).

[0234] The instruction sets and subroutines of the verification process 234, which may be stored on a storage device (e.g., memory system 208) accessible by processing logic 204, may be executed by one or more processors (e.g., primary microprocessor 1314 and / or safety microprocessor 1318) and one or more memory architectures (e.g., memory system 208) included within infusion pump assembly 100. Examples of memory system 208 may include, but are not limited to, random access memory, read-only memory, and flash memory.

[0235] 14 , confirmation process 234 may receive 1400 an initial command processable by one or more applications written in a first computer language on a first microprocessor executing one or more applications written in the first computer language. For example, as discussed above, primary microprocessor 1314 (included within primary processing logic 1304) may be running the Linux® operating system. Assuming user 202 desires to have infusion pump assembly 100 dispense a 0.50 mL dose of infusible fluid 200, user 202 may select (via input system 206 and display system 104) an appropriate command to dispense the 0.50 mL dose. Accordingly, primary microprocessor 1314 may receive 1400 a corresponding command (e.g., command 1332) to dispense 0.50 mL of infusible fluid 200.

[0236] As discussed above, the secure microprocessor 1318 (included within the backup processing logic 1306) may be executing an executive loop. Therefore, the command 1332 may not be provided to the secure microprocessor 1318 in its original form because the secure microprocessor 1318 executing the executive loop and the primary microprocessor 1314 running the Linux operating system may not allow the secure microprocessor 1318 to process the command 1332.

[0237] Thus, the validation process 234 may convert 1402 the initial command 1332 into a modified command (e.g., command 1334) by, for example, the secure microprocessor 1318 (included within the backup processing logic 1306), which may be executing an executive loop. For example, the validation process 234 may convert 1402 the initial command 1332 into a modified command 1334 that is transmittable via a communications protocol (not shown) that achieves communication between the primary microprocessor 1314 and the secure microprocessor 1318. Once 1402 the command 1332 is converted into the modified command 1334, the modified command 1334 may be provided 1404 to, for example, the secure microprocessor 1318 (included within the backup processing logic 1306), which may be executing an executive loop.

[0238] Once received, for example, by secure microprocessor 1318 (included within backup processing logic 1306), secure microprocessor 1318 may process modification command 1334 and provide a visual confirmation to user 202 (e.g., via display system 104). Before processing modification command 1334, validation process 234 may convert modification command 1334 into an original command (not shown) that can be processed by secure microprocessor 1318. For example, upon receiving modification command 1334, secure microprocessor 1318 may process the received modification command 1334 to render a visual confirmation (on display system 104).

[0239] Upon processing the modify command 1334, the confirmation process 234 may render a message on the display system 104 stating, for example, "Do you want to dispense a 0.50 U dose?" Upon reading this message, user 202 may either approve the dispensing of the 0.50 mL dose or cancel the dispensing of the 0.50 mL dose. Thus, if user 202 approves the dispensing of the 0.50 mL dose of infusible fluid 200, the accuracy of both initial command 1332 and modified command 1334 is confirmed. However, if, for example, the message rendered by confirmation step 234 is erroneous (e.g., "Do you wish to dispense a 1.50 mL dose?"), then conversion 1402 of initial command 1332 to modified command 1334 has failed. Thus, primary microprocessor 1314 (and / or applications running on primary microprocessor 1314) and / or safety microprocessor 1318 (and / or applications running on safety microprocessor 1318) may be malfunctioning. Thus, user 202 may need to seek alternative means to cause therapy to be delivered and / or enable infusion pump assembly 100.

[0240] Infusion pump assembly 100, as discussed above, may be configured to deliver infusible fluid 200 to user 202. Infusible fluid 200 may be delivered to user 202 via one or more different infusion event types. For example, infusion pump assembly 100 may deliver infusible fluid 200 via a sequential, multi-part infusion event (which may include multiple discrete infusion events) and / or a single infusion event.

[0241] Examples of such sequential multi-part infusion events may include, but are not limited to, a basal infusion event and an extended bolus infusion event. As is known in the art, a basal infusion event refers to a constant flow of a small amount of infusible fluid 200. However, because such an infusion method is impractical / undesirable for an infusion pump assembly, when administered by such an infusion pump assembly, a basal infusion event may refer to repeated infusions of small amounts (e.g., 0.05 units) of infusible fluid 200 at repeated, predetermined intervals (e.g., every 3 minutes). The amount of infusible fluid 200 delivered during each interval may be the same or may vary from interval to interval. Furthermore, the time interval between each delivery of infusible fluid 200 may be the same or may vary from interval to interval. Furthermore, the basal infusion rate may be set within a preprogrammed time frame, e.g., at a rate of 0.50 units per hour from 6:00 AM to 3:00 PM, at a rate of 0.40 units per hour from 3:00 PM to 10:00 PM, and at a rate of 0.35 units per hour from 10:00 PM to 6:00 AM. However, the basal rate may be 0.025 units per hour and may not change according to a pre-programmed time frame. The basal rate may be repeated periodically / daily until changed otherwise.

[0242] Additionally, as is known in the art, an extended bolus infusion event may refer to repeated infusions of small amounts (e.g., 0.025 units) of infusible fluid 200 at predetermined intervals (e.g., every 3 minutes) repeated for a defined number of intervals (e.g., 3 intervals) or for a defined period of time (e.g., 1 hour). Extended bolus infusion events may occur simultaneously with basal infusion events.

[0243] In contrast, as is known in the art, a regular bolus infusion event refers to a one-time infusion of infusible fluid 200. A volume of infusible fluid 200 to be delivered in a bolus infusion event may be requested, and infusion pump assembly 100 may deliver the requested volume of infusible fluid 200 for the bolus infusion event at a predetermined rate (e.g., as quickly as the infusion pump assembly can deliver). However, the infusion pump assembly may deliver the regular bolus at a slower rate, where the regular bolus volume is greater than a preprogrammed threshold.

[0244] 15-16 , for illustrative purposes only, assume that a user 202 configures the infusion pump assembly 100 to administer a basal dose (e.g., 0.05 units) of infusible fluid 200 every three minutes. As discussed above, the infusion pump assembly 100 may include an input system 206 and a display system 104. Accordingly, the user 202 may utilize the input system 206 to define a basal infusion event (e.g., 1.00 units per hour) of infusible fluid 200, which may be viewed via the display system 104. In this example, the basal infusion event is described as 1.00 units per hour, however, this is for illustrative purposes only and is not intended to be a limitation of the present disclosure, as either or both of the unit amount and duration may be adjusted upward or downward. The infusion pump assembly 100 may then determine an infusion schedule and administer 100 the infusible fluid 200 based on the defined basal infusion event. For example, infusion pump assembly 100 may deliver 0.05 units of infusible fluid 200 every 3 minutes, resulting in delivery of a user-defined basal dose of infusible fluid 200 (ie, 1.00 units per hour).

[0245] Once defined and / or confirmed, the fluid delivery process 236 may administer 1500 sequential multi-part infusion events (eg, 0.05 units of infusible fluid 200 every 3 minutes). Thus, during administration of the sequential multi-part infusion events 1500, the infusion pump assembly 100 may infuse a first 0.05 unit dose 1600 of infusible fluid 200 at t=0:00 (i.e., the first discrete infusion event), a second 0.05 unit dose 1602 of infusible fluid 200 at t=3:00 (i.e., the second discrete infusion event), a third 0.05 unit dose 1604 of infusible fluid 200 at t=6:00 (i.e., the third discrete infusion event), a fourth 0.05 unit dose 1606 of infusible fluid 200 at t=9:00 (i.e., the fourth discrete infusion event), and a fifth 0.05 unit dose 1608 of infusible fluid 200 at t=12:00 (i.e., the fourth discrete infusion event). As discussed above, this pattern of infusing 0.05 unit doses of infusible fluid 200 every 3 minutes may be repeated indefinitely in this embodiment, as this is an exemplary example of a basal infusion event.

[0246] Further, for purposes of illustration, assume that the infusible fluid 200 is insulin, and that some time after a first 0.05 unit dose 1600 of infusible fluid 200 is administered 1500 by the fluid delivery process 236 (but before a second 0.05 unit dose 1602 of infusible fluid 200 is administered 1500 by the fluid delivery process 236), the user 202 checks their blood glucose level and realizes that it is slightly higher than normal. Accordingly, the user 202 may define an extended bolus infusion event via the fluid delivery process 236. An extended bolus infusion event may refer to the continuous infusion of a defined amount of infusible fluid 200 over a finite period of time. However, because such an infusion method is impractical / undesirable for an infusion pump assembly, when administered by such an infusion pump assembly, an extended bolus infusion event may refer to the infusion of additional small doses of infusible fluid 200 over a finite period of time.

[0247] Thus, the user 202 may utilize the input system 206 to define an extended bolus infusion event of infusible fluid 200 (e.g., 0.20 units over the next 6 minutes), which may be confirmed via the display system 104. In this example, the extended bolus infusion event is described as 0.20 units over the next 6 minutes, but this is for illustrative purposes only and is not intended to be a limitation of the present disclosure, as either or both of the unit dose and total time interval may be adjusted upward or downward. Once defined and / or confirmed, the fluid delivery process 236 may determine an infusion schedule and administer 1500 the infusible fluid 200 based on the defined extended bolus infusion event. For example, the infusion pump assembly 100 may deliver 0.10 units of infusible fluid 200 every 3 minutes over the next two interval cycles (or 6 minutes), resulting in the delivery of the user-defined extended bolus dose of infusible fluid 200 (i.e., 0.20 units over the next 6 minutes).

[0248] Thus, while administering 1500 the second sequential multi-part infusion event, infusion pump assembly 100 may infuse a first 0.10 unit dose 1610 of infusible fluid 200 at t=3:00 (e.g., after administering a second 0.05 unit dose 1602 of infusible fluid 200). Infusion pump assembly 100 may also infuse a second 0.10 unit dose 1612 of infusible fluid 200 at t=6:00 (e.g., after administering a third 0.05 unit dose 1604 of infusible fluid 200).

[0249] For illustrative purposes only, assume that after the user 202 programs the infusion pump assembly 100 to administer 1500 a first sequential, multi-part infusion event (i.e., 0.05 units infused every three-minute interval repeated in succession) and to administer 1500 a second sequential, multi-part infusion event (i.e., 0.10 units infused every three-minute interval over two intervals), the user 202 decides to eat a very large meal. Anticipating that blood glucose levels may increase significantly, the user 202 may program the infusion pump assembly 100 (via the input system 206 and / or the display system 104) to administer 1502 a single infusion event. Examples of such a single infusion event may include, but are not limited to, a normal bolus infusion event. As is known in the art, a normal bolus infusion event refers to a single infusion of the infusible fluid 200.

[0250] For illustrative purposes only, assume that user 202 desires to have infusion pump assembly 100 administer 1502 a basal dose of 36 units of infusible fluid 200. Fluid delivery process 236 may monitor the various infusion events being administered by fluid delivery process 236 to determine 1504 whether a single infusion event is available for administration 1502. If a single infusion event is available for administration 1504, fluid delivery process 236 may delay 1506 the administration of at least a portion of the sequential multi-part infusion event.

[0251] Continuing with the above example, once the user 202 has completed programming the fluid delivery process 236 to deliver a single infusion event 1614 (i.e., a 36 unit bolus dose of injectable delivery 200), when the fluid delivery process 236 determines 1504 that a single infusion event is available for administration 1502, the fluid delivery process 236 may delay 1506 the administration 1500 of each sequential multi-part infusion event and administer 1502 the available single infusion event.

[0252] Specifically, as discussed above, before the user 202 programmed the fluid delivery process 236 to deliver the single injection event 1614, the fluid delivery process 236 administered 1500 a first sequential multi-part injection event (i.e., 0.05 units injected every 3 minute interval repeated continuously) and 1500 a second sequential multi-part injection event (i.e., 0.10 units injected every 3 minute interval over two intervals).

[0253] 16 as 0.05 unit dose 1600 @ t = 0:00, 0.05 unit dose 1602 @ t = 3:00, 0.05 unit dose 1604 @ t = 6:00, 0.05 unit dose 1606 @ t = 9:00, and 0.05 unit dose 1608 @ t = 12:00. Because the first sequential multi-part infusion event as described above is a basal infusion event, infusion pump assembly 100 (in conjunction with fluid delivery step 236) may continue to infuse 0.05 unit doses of infusible fluid 200 at 3 minute intervals indefinitely (i.e., until the procedure is canceled by user 202).

[0254] 16 as 0.10 unit dose 1610 @ t=3:00 and 0.10 unit dose 1612 @ t=6:00. Because the second sequential multi-part infusion event is described above as an extended bolus infusion event, infusion pump assembly 100 (in conjunction with fluid delivery step 236) continues to infuse 0.10 unit doses of infusible fluid 200 at 3 minute intervals for exactly two intervals (i.e., the number of intervals defined by user 202).

[0255] Continuing with the above example, if the fluid delivery process 236 determines 1504 that a 36 unit normal bolus dose of infusible fluid 200 (i.e., a single infusion event 1614) is available for administration 1502, the fluid delivery process 236 may delay 1506 the administration 1500 of each sequential multi-part infusion event and may begin administering 1502 the single infusion event 1614 that is available for administration.

[0256] Thus, for illustrative purposes only, assume that upon completing programming of infusion pump assembly 100 to deliver a 36 unit normal bolus dose of infusible delivery 200 (i.e., a single infusion event), the delivery fluid process begins 1502 administering a single infusion event 1614. Because the single infusion event 1614 is a relatively large volume, it may take longer than three minutes to administer (i.e., the time interval between the sequential multi-part infusion events of an individual infusion dose), and therefore, one or more of the sequential multi-part infusion events of the individual infusion dose may need to be delayed.

[0257] Specifically, assume that infusion pump assembly 100 takes more than six minutes to infuse 36 units of infusible fluid 200. Thus, fluid delivery process 236 may delay 0.05 unit dose 1602 (i.e., scheduled to be infused at t=3:00), 0.05 unit dose 1604 (i.e., scheduled to be infused at t=6:00), and 0.05 unit dose 1606 (i.e., scheduled to be infused at t=9:00) until after single infusion event 1614 (i.e., 36 units of the regular bolus dose of infusible fluid 200) has been fully administered. Additionally, fluid delivery process 236 may delay 0.10 unit dose 1610 (i.e., scheduled to be infused at t=3:00) and 0.10 unit dose 1612 (i.e., scheduled to be infused at t=6:00) until after single infusion event 1614.

[0258] Once the administration 1502 of the one-time infusion event 1614 is completed by the fluid delivery process 236, any discrete infusion events contained within the delayed sequential multi-part infusion event may be administered 1500 by the fluid delivery process 236.

[0259] Thus, once the single infusion event 1614 (i.e., 36 units of normal bolus dose of infusible fluid 200) is fully administered 1502, the fluid delivery process 236 may administer 1500 0.05 unit dose 1602, 0.05 unit dose 1604, 0.05 unit dose 1606, 0.10 unit dose 1610, and 0.10 unit dose 1612.

[0260] While the fluid delivery process 236 is shown administering 1500 a 0.05 unit dose 1604, then a 0.10 unit dose 1610, then a 0.05 unit dose 1602, then a 0.10 unit dose 1612, then a 0.05 unit dose 1606, this is for illustrative purposes only and is not intended to be a limitation of the present disclosure, as other configurations are possible and are considered within the scope of the present disclosure. For example, once the fluid delivery process 236 completes administering 1502 a single infusion event 1614 (i.e., a 36 unit regular bolus dose of infusible fluid 200), the fluid delivery process 236 may administer 1500 all of the delayed discrete infusion events associated with the first sequential multi-part infusion event (i.e., 0.05 unit dose 1602, 0.05 unit dose 1604, and 0.05 unit dose 1600). The fluid delivery process 236 may then administer 1500 all of the delayed discrete infusion events associated with the second sequential multi-part infusion event (ie, 0.10 unit dose 1610 and 0.10 unit dose 1612).

[0261] Although the single infusion event 1614 (i.e., a 36 unit normal bolus dose of infusible fluid 200) is shown as being infused beginning at t=3:00, this is for illustrative purposes only and is not intended to be a limitation of the present disclosure. Specifically, the fluid delivery process 236 may not be required to begin infusing the single infusion event 1614 at one of the three-minute intervals (e.g., t=0:00, t=3:00, t=6:00, t=9:00, or t=12:00) and may begin administering the single infusion event 1614 at any time 1502.

[0262] Although each discrete infusion event (e.g., 0.05 unit dose 1602, 0.05 unit dose 1604, 0.05 unit dose 1606, 0.10 unit dose 1610, and 0.10 unit dose 1612) and single infusion event 1614 are shown as being a single event, this is for illustrative purposes only and is not intended to be a limitation of the present disclosure. Specifically, at least one of the multiple discrete infusion events (e.g., 0.05 unit dose 1602, 0.05 unit dose 1604, 0.05 unit dose 1606, 0.10 unit dose 1610, and 0.10 unit dose 1612) may include multiple discrete infusion sub-events. Furthermore, single infusion event 1614 may include multiple single infusion sub-events.

[0263] 17, for illustrative purposes only, 0.05 unit dose 1602 is shown to include 10 discrete infusion sub-events (e.g., infusion sub-events 17001-10), with a 0.005 unit dose of infusible fluid 200 being infused during each of the 10 discrete infusion sub-events. Additionally, 0.10 unit dose 1610 is shown to include 10 discrete infusion sub-events (e.g., infusion sub-events 17021-10), with a 0.01 unit dose of infusible fluid 200 being delivered during each of the 10 discrete infusion sub-events. Furthermore, single infusion event 1614 may include, for example, 360 single infusion sub-events (not shown), with a 0.1 unit dose of infusible fluid 200 being delivered during each of the 360 ​​single infusion sub-events. The number of sub-events and the amount of infusible fluid 200 delivered during each sub-event may be increased or decreased depending, for example, on the design criteria of the pump assembly 100 and / or the implementation of the fluid delivery process 236, and therefore the number of sub-events and the amount of infusible fluid 200 delivered during each sub-event defined above are for illustrative purposes only and are not intended to be limitations of the present disclosure.

[0264] Before, after, or during the above-described infusion sub-events, the infusion pump assembly 100 may verify proper operation of the infusion pump assembly 100, for example, through the use of a force sensor 216 (i.e., which may determine the occurrence of an occlusion) and a displacement detection device 218 (i.e., which may determine the occurrence of a mechanical failure).

[0265] As discussed above, during operation of infusion pump assembly 100, infusible fluid 200 may be delivered to user 202, for example, according to a defined delivery schedule. For illustrative purposes only, assume infusion pump assembly 100 is configured to provide 0.10 mL of infusible fluid 200 to user 202 every three minutes. Thus, every three minutes, processing logic 204 may provide an appropriate drive signal to motor assembly 214 to enable motor assembly 214 to rotate lead screw assembly 228 an appropriate amount so that partial nut assembly 226 (and thus plunger rod assembly 224) may be displaced an appropriate amount in the direction of arrow 230 so that 0.10 mL of infusible fluid 200 is provided to user 202 (via cannula 114).

[0266] The processing logic 204 may execute an occlusion detection process 238, which may be configured to monitor one or more events occurring within the infusion pump assembly 100 to determine whether an occlusion (e.g., a blockage) has occurred, for example, within the cannula assembly 114.

[0267] 18-19, the occlusion detection process 238 may determine 1900 the rate of change of force measurement (eg, FR01) corresponding to the delivery of the first dose 240 (FIG. 2) of infusible fluid 200.

[0268] When determining 1900 the force measurement rate of change (e.g., FR01), occlusion detection process 238 may determine 1902 an initial force measurement prior to injecting first dose 240 of infusible fluid 200. As discussed above, infusion pump assembly 100 may periodically dispense discrete doses of infusible fluid 200 based on one or more infusion schedules. For example, as discussed above, infusion pump assembly 100 may be configured to dispense 0.10 mL of infusible fluid 200 to user 202 every 3 minutes.

[0269] When determining 1902 an initial force measurement before injecting the first dose 240 of infusible fluid 200 , occlusion detection process 238 may obtain the initial force measurement from force sensor 216 . For example, if there is no occlusion in cannula assembly 114, the initial force measurement obtained by occlusion detection process 238 before infusion pump assembly 100 injects first dose 240 of infusible fluid 200 should be zero pounds. Once occlusion detection process 238 determines 1902 the initial force measurement, infusion pump assembly 100 may dispense 1904 first dose 240 of infusible fluid 200 to user 202 through cannula assembly 114. Although the system may be described above and / or below as having a force measurement of zero pounds before and / or after dispensing infusible fluid 200, this is for illustrative purposes only, as frictional forces and / or backpressure may result in a force measurement slightly higher than zero pounds.

[0270] Once infusion pump assembly 100 has dispensed 1904 the first dose 240 of infusible fluid 200 to user 202, occlusion detection process 238 may determine 1906 a final force measurement after dispensing 1904 the first dose 240 of infusible fluid 200. For example, once infusion pump assembly 100 has completely dispensed 1904 the first dose 240 of infusible fluid 200 to user 202, occlusion detection process 238 may obtain a final force measurement from force sensor 216 in a process similar to the process used to obtain the initial force measurement from force sensor 216.

[0271] The occlusion detection process 238 may determine 1900 a force measurement rate of change (e.g., FRO1) based, at least in part, on the initial and final force measurements. For example, the occlusion detection process 238 may subtract the initial force measurement from the final force measurement to determine the net force generated while dispensing (in this particular example) 0.10 mL of infusible fluid 200. As discussed above, if there is no occlusion in the cannula assembly 114, the initial force measurement (obtained from force sensor 216) should be zero and the final force measurement (also obtained from force sensor 216) should also be zero. Therefore, the force measurement rate of change (e.g., FRO1) determined 1900 by the occlusion detection process 238 should also be zero.

[0272] Although the system is described above as determining 1906 a final force measurement after dispensing 1904 a first dose 240 of infusible fluid 200, this final force measurement may actually be based on an initial force measurement obtained for the next dose of infusible fluid 200. Thus, by allowing the initial force measurement of the second dose of infusible fluid 200 to provide data for the final force measurement of the first dose of infusible fluid 200, the total number of force measurements obtained may be reduced by 50%.

[0273] Once the rate of change of force readings (e.g., FR01) is determined, the occlusion detection process 238 may store the rate of change of force readings (e.g., FR01), for example, in a storage cell 1800 of a storage array 1802. The storage array 1802 may be configured as a FIFO (first-in, first-out) buffer. The storage array 1802 may be configured to allow the occlusion detection process 238 to maintain multiple historical values ​​of the rate of change of force readings (e.g., FR01), as discussed above. A typical embodiment of the storage array 1802 may include 20 or 40 individual storage cells. While the storage array 1802 is illustrated in FIG. 18 as being a multi-column storage array, this is for illustrative purposes only and is not intended to be a limitation of the present disclosure. For example, the storage array 1802 may be a single column storage array in which only the rate of change of force readings is stored.

[0274] The occlusion detection process 238 may process historical values ​​of the force reading rate-of-change to determine an average force reading rate-of-change over a desired volume of infusible fluid / number of infusion cycles. For example, the occlusion detection process 238 may determine the average force reading rate-of-change over each of 40 infusion cycles. Accordingly, the occlusion detection process 238 may determine 1908 additional force reading rate-of-change values, each of which corresponds to the delivery of an additional dose of infusible fluid 200. For example, and by way of example only, the occlusion detection process 238 may determine 1908 39 additional force reading rate-of-change values ​​for the next 39 infusion cycles. Each of these 39 force reading rate-of-change values ​​may be stored in a unique storage cell of the storage array 1802. Once the storage array 1802 is completely filled (i.e., contains 40 force reading rate-of-change values), the occlusion detection process 238 may determine the average force reading rate-of-change value for the set of 40 force reading rate-of-change values. Once this average rate of change of force readings is determined, the storage array 1802 may be cleared and the process of collecting additional rate of change of force readings may be repeated.

[0275] Upon determining the additional force reading rate of change, occlusion detection process 238 may determine 1910 an initial force reading before dispensing an additional dose (e.g., dose 242) of infusible fluid 200. Dose 242 of infusible fluid may then be dispensed 1912 by infusion pump assembly 100. Occlusion detection process 238 may determine 1914 a final force reading after dispensing dose 242 of infusible fluid 200.

[0276] Occlusion detection process 238 may determine 1908 an additional rate of change of force reading (e.g., FR2) based, at least in part, on the initial and final force readings for each additional dose of infusible fluid 200. As discussed above, if there is no occlusion in cannula assembly 114, for example, the initial force reading (obtained from force sensor 216) should be zero and the final force reading (also obtained from force sensor 216) should also be zero. Thus, the rate of change of force reading (e.g., FR2) determined 1908 by occlusion detection process 238 should also be zero. As discussed above, once the additional rate of change of force reading (e.g., FR2) is determined, occlusion detection process 238 may store the rate of change of force reading (e.g., FR2), for example, in memory cell 1804 of memory array 1802.

[0277] Assume, for purposes of example, that occlusion detection process 238 continues to calculate rate-of-change force readings in the manner described above and continues to store these calculated rate-of-change force readings in storage array 1802. Assume further, for purposes of example, that infusion pump assembly 100 continues to operate properly (i.e., without occlusion) for the first 33 infusion cycles. Thus, the first 33 force reading rate-of-change (FR01-FR33) are all zero because each initial and final force reading was zero. However, for purposes of illustration, assume that an occlusion (e.g., occlusion 244) occurs in cannula assembly 114 before calculating the 34th force reading rate-of-change (e.g., FR34) to be stored in memory cell 1806. For purposes of illustration, assume that occlusion detection process 238 determines 1910 an initial force reading of 0.00 pounds when calculating the 34th force reading rate-of-change (e.g., FR34). At the time infusion pump assembly 100 begins to dispense 1912 the 34th dose of infusible fluid 200, because occlusion 244 is present in cannula assembly 114, fluid displaced from reservoir assembly 200 by plunger rod assembly 224 is unable to pass through cannula assembly 114. Thus, pressure begins to build up in reservoir assembly 200. Thus, for illustrative purposes, assume that the occlusion detection process 238 determines 1914 a final force reading of 0.50 lbs. Thus, for a rate of change of 0.50 lbs, the occlusion detection process 238 may determine 1908 that the force reading rate of change (e.g., FR34) is 0.50 lbs minus 0.00 lbs.

[0278] Due to the presence of occlusion 244 in cannula assembly 114, there is still 0.50 pounds of pressure in fluid reservoir 200 as sensed by force sensor 216 when motor assembly 214 attempts to dispense the next dose of infusible fluid 200. Thus, the initial force measurement determined by the occlusion detection process 238 when determining the 35th force measurement rate of change (e.g., FR35) may be the same as the final force measurement determined by the occlusion detection process 238 when determining the 34th force measurement rate of change (e.g., FR34).

[0279] The occlusion detection process 238 may determine 1916 an average force reading rate of change (e.g., AFR) based on at least all or a portion of the force reading rates of change contained in the storage array 1802. For purposes of illustration, assume that the occlusion detection process 238 is configured to consider all force reading rates of change (e.g., FR01-FR40) contained in the storage array 1802. Thus, the occlusion detection process 238 may calculate a mathematical average of all force reading rates of change (e.g., FR01-FR40) contained in the storage array 1802. In this particular example, the average force reading rate of change (e.g., AFR) has a mathematical value of 0.105 pounds. While the system is described above as being capable of considering all force reading rates of change (e.g., FR01-FR40) contained in the storage array 1802, other configurations are possible, and this is for illustrative purposes only and is not intended to be a limitation of the present disclosure. For example, the occlusion detection process 238 may be configured to determine 1916 an average force reading rate of change (e.g., AFR) once the storage array 1802 is populated with, for example, the first five force reading rates of change. If the average force reading rate of change (e.g., AFR) is determined 1916 before the storage array 1802 is completely populated, unpopulated rows in the storage array 1802 may be populated with zeros.

[0280] The occlusion detection process 238 may compare the average force reading rate of change (e.g., AFR) to a threshold force reading rate of change to determine whether the average force reading rate of change (e.g., AFR) exceeds a threshold force reading rate of change 1918. If the average force reading rate of change does not exceed the threshold force reading rate of change 1920, the infusion pump assembly 100 may continue to operate normally. However, if the average force reading rate of change exceeds the threshold force reading rate of change, an alarm sequence may be initiated in the infusion pump assembly 100 1922. For example, and for illustrative purposes, assume that the occlusion detection process 238 is configured with a threshold force reading rate of change of 0.90 pounds, then the alarm sequence may be initiated only after the average force reading rate of change (e.g., AFR) exceeds 0.90 pounds 1920. Thus, in these embodiments, measuring the rate of change may ensure that the alarm sequence is triggered more reliably than when an actual occlusion occurs. As described below, the user 202, in some embodiments, defines the sensitivity of the system.

[0281] The sensitivity of the occlusion detection process 238 may be based on a user-defined sensitivity setting selected 1924, for example, by the user 202. For example, assume that the occlusion detection process 238 has two sensitivity settings: a high sensitivity setting and a low sensitivity setting. Further assume that each sensitivity setting is associated with a unique scheme for determining the rate of change of force readings contained within the storage array 1802. As discussed above, the occlusion detection process 238 is described as determining 1900 a rate of change of force readings (e.g., FR01) corresponding to the delivery of a first dose 240 of infusible fluid 200. Assume further that when configured with a high sensitivity setting, the occlusion detection process 238 may determine 1900 a rate of change of force readings corresponding to the delivery of a relatively small amount of infusible fluid 200. Further assume that when configured with a low sensitivity setting, the occlusion detection process 238 may determine 1900 a rate of change of force readings corresponding to the delivery of a relatively large amount of infusible fluid 200. For example, assume that when configured with a high sensitivity setting, the occlusion detection process 238 determines 1900 the rate of change of force readings corresponding to the delivery of 0.10 mL of infusible fluid 200. Further, assume that when configured with a low sensitivity setting, the occlusion detection process 238 determines 1900 the rate of change of force readings corresponding to the delivery of a 0.20 mL dose 240 of infusible fluid 200. Thus, when a high sensitivity setting is used, additional measurements are obtained, and the occlusion detection process 238 becomes more responsive. However, false alarms may occur more frequently. Conversely, when a low sensitivity setting is used, fewer measurements are obtained, and the occlusion detection process 238 becomes less responsive. However, false alarms may occur less frequently due to the “averaging” effect of obtaining fewer measurements. Therefore, to avoid nuisance alarms (or reduce the number of alarms), a user (e.g., user 202) may select 1924 a low sensitivity setting.

[0282] The initiated 1922 alert sequence may include any combination of visual-based (via display system 104), audible-based (via sound system 212), and vibration-based (via vibration system 210) alerts. The user 202 may be able to select between a high sensitivity setting and a low sensitivity setting via one or more of the input system 206 and the display system 104.

[0283] Although infusion pump assembly 100 is described above as delivering multiple equal-sized doses of infusible fluid 200 and calculating a rate of change of force reading (e.g., FRO1) for each dose of infusible fluid 200, this is for illustrative purposes only and is not intended to be a limitation of the present disclosure. Specifically, infusion pump assembly 100 may be configured to provide non-equal doses of infusible fluid 200. Additionally, as discussed above, infusion pump assembly 100 may be configured to allow user 202 to manually administer a "bolus" dose of infusible fluid 200 with a size determined by user 202. Accordingly, occlusion detection process 238 may be configured to monitor the volume of infusible fluid 200 dispensed in each dose and may be configured to populate memory array 1802 such that the rate of change of force reading (e.g., FRO1) contained therein is indicative of the rate of change of force reading sensed by occlusion detection process 238 when dispensing an equivalent volume of infusible fluid 200. Thus, occlusion detection process 238 may be configured to "normalize" the rate of change of force measurements determined based on the amount of infusible fluid delivered.

[0284] For example, assume that occlusion detection process 238 is configured to populate a storage cell contained within storage array 1802 each time 0.10 mL of infusible fluid 200 is dispensed. For purposes of illustration only, assume that user 202 decides to dispense a 0.25 mL dose of infusible fluid 200. Because a 0.25 mL dose of infusible fluid 200 is larger than the 0.10 mL increment that occlusion detection process 238 is configured to populate in storage array 1802, occlusion detection process 238 may record multiple entries in storage array 1802 (and thus populate multiple storage cells) for the single 0.25 mL dose of infusible fluid 200.

[0285] Specifically, assume that the initial force measurement determined 1910 before delivering a 0.25 mL dose of infusible fluid 200 is 0.00 lbs, and the final force measurement determined 1914 after dispensing 1912 the 0.25 mL dose of infusible fluid 200 is 1.00 lbs. Because a 0.25 mL dose of infusible fluid 200 is 2.5 times the 0.10 mL increment that occlusion detection process 238 is configured to populate storage array 52, occlusion detection process 238 may "normalize" this rate of change of force reading. Specifically, occlusion detection process 238 may divide 1.00 pounds by 0.25 mL to determine that the force changed by 0.40 pounds per 0.10 mL. Thus, occlusion detection process 238 may calculate a rate of change of force reading of 0.40 pounds for the first 0.10 mL dose of infusible fluid 200, 0.40 pounds for the second 0.10 mL dose of infusible fluid 200, and 0.20 pounds for the final 0.05 mL dose of infusible fluid 200.

[0286] Thus, occlusion detection process 238 may populate storage array 1802 such that a first storage cell (associated with a first 0.10 mL dose of infusible fluid 200) defines an initial force reading of 0.00 pounds, a final force reading of 0.40 pounds, and a force reading rate-of-change of 0.40 pounds. Additionally, occlusion detection process 238 may populate storage array 1802 such that a second storage cell (associated with a second 0.10 mL dose of infusible fluid 200) defines an additional force reading of 0.40 pounds, a final force reading of 0.80 pounds, and a force reading rate-of-change of 0.40 pounds.

[0287] With respect to the remaining 0.05 mL of the 0.25 mL dose of infusible fluid 200, because this is less than the 0.10 mL increment that occlusion detection process 238 is configured to populate storage array 1802 with, the next cell in storage array 1802 will not be populated until an additional 0.05 mL dose of infusible fluid 200 is dispensed.

[0288] Continuing with the above example, assume for purposes of illustration that infusion pump assembly 100 administers a 0.15 mL dose of infusible fluid 200. Occlusion detection process 238 may combine the first 0.05 mL of the 0.15 mL dose of infusible fluid 200 with the remaining 0.05 mL of the 0.25 mL dose of infusible fluid 200 to form a total increment of 0.10 mL for recording in storage array 1802.

[0289] Again, occlusion detection process 238 may "normalize" a 0.15 mL dose of infusible fluid 200. For illustrative purposes, assume that when dispensing a 0.15 mL dose of infusible fluid 200, occlusion detection process 238 determines an initial force measurement of 1.00 pounds and a final force measurement of 1.60 pounds. In the manner described above, occlusion detection process 238 may divide 0.60 pounds (i.e., 1.60 pounds minus 1.00 pounds) by 0.15 mL to determine that the force changed by 0.40 pounds per 0.10 mL. Thus, occlusion detection process 238 may calculate a force measurement change rate of 0.20 pounds for the first 0.05 mL of the 0.15 mL dose of infusible fluid 200 and 0.40 pounds for the remaining 0.10 mL of the 0.15 mL dose of infusible fluid 200.

[0290] Thus, the occlusion detection process 238 may populate the memory array 1802 such that the third memory cell (associated with the combination of the first 0.05 mL of the 0.15 mL dose of infusible fluid 200 with the remaining 0.05 mL of the 0.25 mL dose of infusible fluid 200) defines an initial force measurement of 0.80 pounds (i.e., the final force measurement after the second 0.10 mL of the 0.25 mL dose of infusible fluid 200), a final force measurement of 1.20 pounds (i.e., the sum of the initial force measurement of 1.00 pounds plus 0.20 pounds offset for the first 0.05 mL of the 0.15 mL dose of infusible fluid 200), and a force measurement rate of change of 0.40 pounds. Further, the occlusion detection process 238 may populate the memory array 1802 such that the fourth memory cell (associated with the last 0.10 mL of the 0.15 mL dose of infusible fluid 200) defines an initial force measurement of 1.20 pounds, a final force measurement of 1.60 pounds, and a force measurement rate of change of 0.40 pounds.

[0291] In addition to comparing 1918 the average force reading rate of change (e.g., AFR) to a threshold force reading rate of change to determine whether the average force reading rate of change (e.g., AFR) exceeds a threshold force reading rate of change, occlusion detection process 238 may compare 1926 one or more of the initial and final force readings to a threshold force reading to determine whether either the initial or final force reading exceeds the threshold force reading. If either the initial or final force reading exceeds the threshold force reading, an alarm sequence may be initiated 1928 in infusion pump assembly 100.

[0292] For example, occlusion detection process 238 may define a threshold force measurement that, if exceeded by either an initial force measurement (determined before dispensing a dose of infusible fluid 200) or a final force measurement (determined after dispensing a dose of infusible fluid 200), an occlusion is deemed to have occurred. An example of such a threshold force measurement is 4.00 pounds. Thus, if occlusion detection process 238 determines a final force measurement of 5.20 pounds after dispensing a dose of infusible fluid 200, occlusion detection process 238 may initiate 1928 an alarm sequence because 5.20 pounds exceeds the 4.00 threshold force measurement. The initiated 1928 alarm sequence may include any combination of visual (via display system 104), audible (via sound system 212), and vibration (via vibration system 210) alarms.

[0293] As discussed above, infusion pump assembly 100 may include a primary power supply 220 configured to power infusion pump assembly 100. Before and / or after dispensing a dose of infusible fluid 200, occlusion detection process 238 may compare the actual voltage level of primary power supply 220 with a minimum voltage requirement 1930 to determine whether the actual voltage level of primary power supply 220 meets the minimum voltage requirement. If the actual voltage level does not meet the minimum voltage requirement, occlusion detection process 238 may initiate an alarm sequence 1932 in infusion pump assembly 100. The initiated 1932 alarm sequence may include any combination of visual (via display system 104), audible (via sound system 212), and vibration (via vibration system 210) alarms. For example, for illustrative purposes, assume primary power supply 220 is a 5.00 VDC battery. Further, assume the minimum voltage requirement is 3.75 VDC (i.e., 75% of nominal voltage). Thus, if occlusion detection process 238 determines 1930 that the actual voltage level of primary power supply 220 is 3.60 VDC, occlusion detection process 238 may initiate 1932 an alarm sequence in infusion pump assembly 100 .

[0294] Additionally, occlusion detection process 238 may monitor one or more of the displaceable mechanical components included within infusion pump assembly 100 to determine 1934 whether one or more displaceable mechanical components included within infusion pump assembly 100 have been displaced an expected displacement in response to delivery 200 of a dose of infusible fluid. If a monitored displaceable mechanical component has not been displaced an expected displacement in response to delivery 200 of a dose of infusible fluid, occlusion detection process 238 may initiate 1936 an alarm sequence in infusion pump assembly 100. The initiated 1936 alarm sequence may include any combination of visual (via display system 104), audible (via sound system 212), and vibration-based (via vibration system 210) alarms.

[0295] For example, when processing logic 204 energizes motor assembly 214 to dispense 0.10 mL of infusible fluid 200, occlusion detection process 238 may confirm (via displacement detection device 218) that partial nut assembly 226 has actually moved the expected displacement. Thus, if partial nut assembly 226 does not move the expected displacement, a mechanical failure may have occurred (e.g., a failure of partial nut assembly 226, a failure of lead screw assembly 228, or a failure of motor assembly 214). If the expected displacement of partial nut assembly 226 cannot be confirmed, occlusion detection process 238 may initiate 1936 an alarm sequence in infusion pump assembly 100.

[0296] A tolerance may be utilized when determining whether partial nut assembly 226 has been displaced the expected displacement. For example, assuming a 0.10 mL dose of infusible fluid 200 is to be delivered, occlusion detection process 238 may expect partial nut assembly 226 to be displaced 0.050 inches. Accordingly, occlusion detection process 238 may utilize a 10% error window of 1936 where movement of partial nut assembly 226 of less than 0.045 inches (i.e., 10% less than expected) will cause occlusion detection process 238 to initiate an alarm sequence in infusion pump assembly 100.

[0297] In one embodiment of displacement detection device 218, displacement detection device 218 includes one or more light sources (not shown) mounted on one side of partial nut assembly 226 and one or more light detectors (not shown) mounted on the other side of partial nut assembly 226. Partial nut assembly 226 may include one or more passageways (not shown) through which light from one or more light sources (not shown) included within displacement detection device 218 may shine and be detected by one or more light detectors (not shown) included within displacement detection device 218.

[0298] 20 , in some embodiments of the infusion pump system, the infusion pump may be remotely controlled using a remote control assembly 2000. The remote control assembly 2000 may include all or a portion of the functionality of the pump assembly itself. Thus, in some exemplary embodiments of the infusion pump assembly described above, the infusion pump assembly (not shown, see FIGS. 1A-1F, among others) may be configured via the remote control assembly 2000. In these particular embodiments, the infusion pump assembly may include telemetry circuitry (not shown) that enables communication (e.g., wired or wireless) between the infusion pump assembly and, for example, the remote control assembly 2000, thus enabling the remote control assembly 2000 to remotely control the infusion pump assembly 100′. Remote control assembly 2000 (which may also include telemetry circuitry (not shown) and may be capable of communicating with the infusion pump assembly) may include a display assembly 2002 and an input assembly that may include one or more of an input control device (such as a jog wheel 2006, a slider assembly 2012, or another conventional manner of providing input to a device), and switch assemblies 2008, 2010. Thus, remote control assembly 2000 as shown in FIG. 20 includes a jog wheel 2006 and a slider assembly 2012, although in some embodiments, only one of jog wheel 2006 or slider assembly 2012, or another conventional manner of providing input to a device, may be included. In embodiments having a jog wheel 2006, jog wheel 2006 may include a wheel, ring, knob, or the like that may be coupled to a rotary encoder or other rotary transducer to provide a control signal based, at least in part, on movement of the wheel, ring, knob, or the like.

[0299] The remote control assembly 2000 may include the ability to pre-program basal rates, bolus alarms, delivery limits, and allow the user to view history and establish user preferences. The remote control assembly 2000 may also include a glucose strip reader 2014.

[0300] During use, remote control assembly 2000 may provide instructions to the infusion pump assembly via a wireless communication channel established between remote control assembly 2000 and the infusion pump assembly. Thus, a user may use remote control assembly 2000 to program / configure the infusion pump assembly. Some or all of the communications between remote control assembly 2000 and the infusion pump assembly may be encrypted to provide an enhanced level of security.

[0301] (Prevention of over-delivery) In various embodiments, the infusion pump includes a reservoir. In some embodiments, the reservoir may be removable, while in some embodiments, the reservoir may not be removable. Referring now to FIG. 21 , in some embodiments, the infusion pump may deliver the infusible fluid from the reservoir to the user through a length of tubing 2100 that includes a luer connection 2102 on one end (in some embodiments, proximal to the pump) for coupling to the reservoir and a cannula 2104 on the distal end. In some embodiments, the tubing 2100 may be removably connected to the cannula. In some embodiments, the cannula includes a male part 2106 and a female part 2108, which connects to the female part 2108, which is fluidly connected to the cannula. In some embodiments, the male part 2106 may be attached to the tubing 2100, and the female part 2108 may be attached to the cannula and the user. However, with reference to Figure 22, in some embodiments, both the male 2106 and female parts 2108 may be attached to the tubing 2100. As shown in Figures 21 and 22, in some embodiments, the cannula 2104 may be maintained on the user with an adhesive patch 2110. In some embodiments, the male part 2106 includes a needle 2112 that may puncture a septum (not shown) located in the female part 2108.

[0302] 21-22 , in some embodiments, the male part 2106 and the female part 2108 may include a means for determining whether the male part 2106 and the female part 2108 are connected. In some embodiments, when the male part 2106 and the female part 2108 are connected, a fluid pathway is formed such that infusible fluid can be delivered from the reservoir to the cannula 2104. When the male part 2106 and the female part 2108 are not connected, the fluid pathway is blocked such that infusible fluid cannot be delivered from the reservoir to the cannula 2104.

[0303] In some embodiments, it may be desirable for the pump and / or controller and / or remote control device and / or processing logic and / or user and / or caregiver to know when the male part 2106 and female part 2108 are connected. In some embodiments, when priming, if the user / pump is performing a task / method, it may be dangerous / unsafe for the user to be connected to the reservoir (i.e., the term “connected” is used to indicate when there is a fluid path between the cannula (in the user) / user and the reservoir). These include, but are not limited to, priming when the reservoir is not connected to and / or within the pump, when the reservoir compartment / housing cap is being adjusted or removed from the pump, and / or while “rewinding” the pump. The term rewind may be used to refer to when the drive mechanism that drives the reservoir plunger rod forward (e.g., to deliver fluid) is driven backward (rather than forward) while delivering and / or infusing fluid from the reservoir into tubing. Generally, it may be dangerous / unsafe for the user to be connected to the reservoir when infusible fluid may be delivered to the user without the user's knowledge / request for infusible fluid to be delivered. Thus, in these types of cases, it may be recommended that the user "disconnect" from the pump and / or reservoir, for example, so that the male and female parts 2106, 2108 are not connected, or any other means of blocking the fluid path between the reservoir and the user.

[0304] Thus, some embodiments may include a method and / or system and / or device for determining whether the male part 2106 and the female part 2108 are connected. Some embodiments of a system for determining whether the male part 2106 and the female part 2108 are connected are detailed below, although other methods and systems for determining whether the male part 2106 and the female part 2108 are connected may be used.

[0305] 21-22 , in some embodiments, there may be electrical contacts 2114, 2116 (which may be wires in some embodiments) on the male and female parts 2106, 2108 so that a circuit is completed when the male and female parts 2106, 2108 mate. In some embodiments, one or more wires may be molded into the tubing 2100. This may be used to transmit an electrical signal to a pump processor as to whether the male and female parts 2106, 2108 are connected or not. In some embodiments, either or both of the male and female parts 2106, 2108 may include an antenna. The antenna may be used to wirelessly communicate with a medical device / infusion pump / remote control device. In some embodiments, one of the male and female parts 2106, 2108 may include an RFID chip and the other of the male and female parts 2106, 2108 may include an antenna. This RFID system may be used to determine when the male and female parts 2106, 2108 are connected. An antenna for wireless communication with the pump / remote control device or both may also be included. In various other embodiments, any means for determining that the male part 2106 and female part 2108 are connected and / or for communicating information to the pump and / or remote control device may be used.

[0306] In some embodiments, one or more steps / methods must not be performed and / or may trigger a warning and / or alarm while the male part 2106 and female part 2108 are connected. For example, but not limited to, these steps / methods may lead to over-delivery and / or accidental and / or unintentional delivery of infusible fluid if performed while the male part 2106 and female part 2108 are connected. These steps / methods include, but are not limited to, priming the reservoir, replacing and / or removing the reservoir, and unwinding and / or removing / turning the reservoir housing cap. In some embodiments, if one of these steps / methods is performed by the user, the pump / processing system may sound an alarm and / or "lock out" the process until the user is disconnected. For example, with reference to FIG. 23 , when a user programs the pump to “prime” or “rewind” (e.g., a command received by the pump processor instructing the pump to prime or rewind), the pump / processing system / pump processor may check whether the user is connected to the pump / reservoir. If the user is connected to the reservoir, the pump / remote control device may, in some embodiments, display and / or sound an alarm and / or warning message, which may include the content “Must Disconnect.” In some embodiments, the pump system may prevent the priming / rewind function until the user is disconnected. In other embodiments, the pump system issues an alarm / warning, and in some embodiments, the alarm / warning may be recoverable by user / caregiver confirmation.

[0307] In some embodiments, a sensor may be included in the reservoir housing cap to determine when the cap is removed and / or turned. The sensor may include, but is not limited to, a Hall Effect sensor, a capacitive / electrical sensor, and / or an electrical contact. Thus, in some embodiments in which the system senses that the reservoir housing cap has been removed and / or turned, if the system also determines that the male part 2106 and the female part 2108 are connected, the system may issue an alarm / warning to the user to disconnect.

[0308] In various embodiments, other methods of determining whether the male and female parts 2106, 2108 are connected may include, but are not limited to, determining the fluid pressure in the fluid line (i.e., between the luer and the cannula). For example, when the male and female parts 2106, 2108 are connected, the pressure may be different than when the male and female parts 2106, 2108 are not connected. In various embodiments, other methods and systems may be used to determine whether the male and female parts 2106, 2108 are connected.

[0309] 24 , in some embodiments, reservoir housing 2400 may include a pusher 2402 that may be driven by a motor (not shown). Pusher 2402 is driven via motor connection 2404. As shown in FIG. 24 , reservoir 2406 may be disposed within reservoir housing 2400. Reservoir 2406, in some embodiments, may include plunger 2408 and plunger contacts 2410. In some embodiments, prior to loading reservoir 2406 into reservoir housing 2400, pusher 2402 is “unwound” such that the motor drives pusher 2402 until unwinding is stopped, for example, by user input or when pusher 2402 has been unwound as far as possible. Once the reservoir 2406 is loaded into the reservoir housing 2400, in some embodiments, the motor drives the pusher 2402 forward until it contacts the plunger contact 2410. In this manner, the reservoir 2406 can be filled to any volume and the drive system can drive the pusher 2402 to the plunger contact 2410. Thus, in some embodiments, the pump system does not need to receive information from a user or otherwise about the volume of fluid in the reservoir 2406 prior to loading the reservoir 2406 into the reservoir housing 2400. Thus, the motor drives the pusher 2402 until it contacts the plunger contact 2010. Thus, in some embodiments, it may be desirable to determine when the pusher 2402 contacts the plunger contact 2010. In some embodiments, once the system detects that the pusher 2402 is in contact with the plunger contact 2010, the motor stops driving the pusher 2402 until a programmed basal or bolus delivery is scheduled. The embodiment shown in Figure 24 represents one embodiment. However, in various other embodiments, the pusher may be in direct contact with the plunger 2408.

[0310] In some embodiments, the system may detect a load change on the drive motor when the drive mechanism transitions from no load to pushing the syringe (i.e., from no load to contact between the pusher 2402 and plunger contact 2010). This load change may cause the motor to slow down and its current to increase. In some embodiments, the motor has an encoder that can be used to monitor the speed of the motor. The current may, in some embodiments, be monitored by placing a small resistor in series with the motor and monitoring the voltage across the resistor. This may, in some embodiments, be done using an operational amplifier or comparator to increase the signal voltage to a value that the microprocessor can utilize. In some embodiments, the system may monitor the motor speed and / or motor current while the drive is being retracted and during the initial advancement of the drive while priming. This may provide a baseline for these values. When the pusher 2402 contacts the plunger contact 2010, the system may detect this by noting a decrease in motor speed and / or motor current. In some embodiments, this may be used in conjunction with a force sensor that may monitor the increase in force to signal that the pusher 2402 is in contact with the plunger contact 2010.

[0311] In some embodiments, the motor may be run backward for a predetermined amount of time, followed by moving the motor forward for a predetermined amount of time. The current may be measured while the motor is run backward and forward. The current required to achieve a known / predetermined motor speed may be determined. While running the motor forward, once the plunger contact 2410 contacts the pusher 2402, the current rises like a step function. Thus, if the current value does not change, then the pusher 2402 has not reached the plunger contact 2410. Therefore, referring also to FIG. 25 , a method 2500 for determining when the pusher 2402 is in contact with the plunger contact 2410 may include steps 2502 of measuring the motor current, 2504 of running the motor backward for a predetermined amount of time, 2506 of running the motor forward, when the current is measured 2508, and 2510 of determining that the pusher 2402 is in contact with the plunger contact 2410.

[0312] In some embodiments, the system may monitor the encoder timing, and when there is a change, or a change greater than a predetermined threshold, this may signal that the pusher 2402 is in contact with the plunger contact 2010.

[0313] In some embodiments, there may be more than one strain gauge or load cell, and in some embodiments, each load cell may be tuned differently, for example, one for occlusion detection, one for detecting when the pusher 2402 contacts the plunger contact 2410, etc.

[0314] In some embodiments, the plunger contact 2410 may be conductively coated and the pusher 2402 may include two electrodes, e.g., a positive and a negative electrode. In some embodiments, an electrical signal indicates when the plunger contact 2410 and the pusher 2402 make contact. In some embodiments, the electrical signal may be sent to the infusion pump and / or a remote controller and / or another device or apparatus to indicate communication to the user / caregiver.

[0315] In some embodiments, proximity sensors may be used, including, but not limited to, Hall effect sensors and / or capacitive sensors and / or optical sensors. For various embodiments using proximity sensors, the plunger contact 2010 may include one element of the sensor and the pusher 2402 may include the other element of the sensor. Thus, upon contact, a signal is generated to indicate such.

[0316] In some embodiments, a linear sensor may be used to determine when the pusher 2402 and plunger contacts 2410 make contact. The linear sensor may be any type of linear sensor, including, but not limited to, an optical sensor. In some embodiments, the linear sensor may be one described in U.S. Patent No. 7,498,563, issued March 3, 2009, entitled "Optical Displacement Sensor for Infusion Devices" (Attorney Docket No. D78), and U.S. Application No. 12 / 395,862, issued March 2, 2009, entitled "Optical Displacement Sensor for Infusion Devices," now Patent Application Publication No. US-2009-0224145-A1, published September 10, 2009 (Attorney Docket No. G87), both of which are incorporated herein in their entireties. In some embodiments, the linear sensor may include, but is not limited to, the use of a reflective or transmissive optical sensor. In various linear sensor embodiments, the reservoir housing may include one or more light emitters in one section and a light sensor in another section. The linear sensor may determine when the pusher 2402 and plunger contacts 2410 touch.

[0317] 26A and 26B, methods, systems, and devices for priming an infusion pump and / or performing a system check / confirming an occlusion alarm are shown. A user / caregiver may wish to prime an infusion pump and / or verify / test / check / confirm that the occlusion alarm is functioning, for example, when changing a reservoir. In some embodiments, both of these tasks may be completed using the following methods / systems / devices. However, in some embodiments, the following methods / systems / devices may be used when priming may not necessarily be desired, but the user / caregiver may verify / test / check / confirm that the occlusion alarm is functioning.

[0318] Thus, in some embodiments, when priming the infusion pump 2602 and / or to complete an occlusion alarm check of the infusion pump 2602, a male part 2606 attached to the end of tubing 2604, which may be part of a cannula set and / or infusion set, may be attached / connected to a priming cap 2608 (see step 2614). In various embodiments, the priming cap 2608 may be any shape and / or size, but the priming cap 2608 may include, for example, but not limited to, a septum 2610 or other sterile puncture site, which may include a silicone material that provides occlusion of the tubing 2604 when the needle 2612 of the male part 2606 is connected to the septum 2610. This may be effectively accomplished when the male part 2606 is attached / connected to the priming cap 2608. The priming cap 2608, in various embodiments, includes a mating feature for the male part 2606, as well as a female part, shown in FIG. 21 as 2108. After male part 2606 is attached to priming cap 2608, the infusion pump may be primed and / or commanded to follow a series of steps to prime the infusion pump (see step 2616). In some embodiments, priming may be commanded directly to infusion pump 2602 using a user input device on the infusion pump, such as those described herein, while in some embodiments, infusion pump 2602 may be commanded to prime using a remote control assembly. In some embodiments, priming continues until and unless an occlusion alarm indicates an occlusion 2618, which may be indicated on a display assembly on infusion pump 2602, as shown in FIG. 26A, or on a display assembly of a remote control (see FIG. 20, 2002), and / or as an alarm, e.g., audio and / or visual and / or vibration. Thus, the infusion pump 2602 pumps fluid through the tubing 2604 and needle 2612 into the septum 2610 in the priming cap 2608, and therefore, after a while, the fluid will exhibit an obstruction because the tubing 2604 is essentially blocked since the fluid cannot flow further than the septum 2610.This may then trigger an occlusion indication by the infusion pump and / or remote control. Thus, if an occlusion indication is not triggered after a predetermined amount of time of priming, e.g., after two minutes, this may be an indication that the occlusion alarm is not functioning properly, i.e., an occlusion alarm failure may exist, and therefore an indication may be given to the user / caregiver to contact a service provider and / or discontinue use of the infusion pump.

[0319] After the occlusion alarm, the male part 2606 may be disconnected from the priming cap 2608 (see step 2620) and air / pressure and fluid are vented and / or released from the infusion pump system 2622. In some embodiments, the occlusion alarm may stop at this time and / or will not alarm further after being silenced by the user / caregiver.

[0320] In some embodiments, a hemostat rather than a priming cap may be used to occlude the tubing 2604. In these embodiments, the hemostat is attached to the tubing 2604 before priming the infusion pump 2602. The hemostat functions similarly to the priming cap 2608 described above, in that the hemostat occludes the tubing 2604. Any device that functions as a hemostat may be used and, in some embodiments, may be included in the system, as discussed below.

[0321] Thus, in some embodiments, a system for priming and / or for checking for occlusion alarms and / or for preventing priming in a user may include an infusion set that may include tubing 2604 attached to a male part 2606, with a cannula 2104 attached to an adhesive patch 2110 and that may include a female part 2108, as shown in FIG. 21 . In some embodiments, the user / caregiver may use the priming cap 2608 every time priming occurs, while in some embodiments, the priming cap may be used to prime at a time selected by the user / caregiver, for example, every three primings. However, in some embodiments, the priming cap 2608 may be used to prime during reservoir changes. However, in some embodiments, the priming cap 2608 may be used to prevent a user from priming the cannula. Thus, in some embodiments, it may be beneficial for the user to always use the priming cap when priming, so that the user can prevent unintentionally priming the user with water by unintentionally failing to disconnect the cannula when priming, which may contain an unintentional fluid dose and be harmful to the user's health. Thus, in some embodiments, the above methods, systems, and devices may be methods, systems, and devices for preventing priming the user.

[0322] Although several embodiments have been described, it will be understood that various modifications may be made. Accordingly, other implementations are within the scope of the following claims.

[0323] While the principles of the invention have been described herein, it will be understood by those skilled in the art that this description is made by way of example only and not as a limitation on the scope of the invention. In addition to the exemplary embodiments shown and described herein, other embodiments are contemplated within the scope of the invention. Modifications and substitutions by those skilled in the art are deemed to be within the scope of the invention. A first aspect of the present invention is 1. A system for priming an infusion pump, comprising: The system comprises: A system comprising a priming cap including a septum, the priming cap configured to mateably connect with a male part, the male part including a needle and attached to a length of tubing for fluid, the priming cap occluding the tubing when mateably connected to the male part. A second aspect of the present invention is The system of the first aspect, further comprising a reservoir, wherein the tubing is removably connected to the reservoir, and wherein fluid from the reservoir is in fluid communication with the tubing. A third aspect of the present invention is 1. A method for priming an infusion pump assembly, comprising: The method comprises: connecting a male fitting to a priming cap, the male fitting including a needle attached to a length of tubing, the priming cap including a septum; commanding an injection pump to prime; priming the injection pump into the priming cap; The method includes: A fourth aspect of the present invention is 1. A method for performing an occlusion alarm check, comprising: The method comprises: connecting a male fitting to a priming cap, the male fitting including a needle attached to a length of tubing, the priming cap including a septum; commanding an injection pump to prime; priming the injection pump into the priming cap for a predetermined time; once an obstruction alarm occurs, removing the male part from the priming cap; determining an occlusion alarm failure if no occlusion alarm occurs after a predetermined amount of time; The method includes: A fifth aspect of the present invention is 1. A system for determining connection to a cannula, comprising: The system comprises: a male part connected to a piece of tubing; a female part fluidly connected to the cannula; electrical contacts on the male and female components, the electrical contacts completing a circuit when the male component is connected to the female component; It is a system that includes A sixth aspect of the present invention is A system as described in a fifth aspect, wherein the one tubing further includes one or more wires that are electrically connected to the circuit and electrically connected to an infusion pump, whereby electrical signals are transmitted to the infusion pump using the wires. A seventh aspect of the present invention is The system of claim 6, wherein the infusion pump further comprises a pump processor, whereby the pump processor receives the electrical signal. An eighth aspect of the present invention is The system of claim 7, further comprising a reservoir in fluid communication with the length of tubing. A ninth aspect of the present invention is a method for manufacturing a semiconductor device comprising: 1. A system for determining connection to a cannula, comprising: The system comprises: a male part connected to a piece of tubing; a female part fluidly connected to the cannula; an RFID chip located on the male component; an antenna located on the female component in communication with the RFID chip, the antenna wirelessly communicating with a medical device to indicate whether the male and female components are connected; and The system includes: A tenth aspect of the present invention is a method for manufacturing a semiconductor device comprising: 1. A system for priming an infusion pump, comprising: The system comprises: a male fitting connected to a piece of tubing; a female part fluidly connected to the cannula; an RFID chip located on the male component; an antenna located on the female component in communication with the RFID chip, the antenna wirelessly communicating with the infusion pump to indicate whether the male and female components are connected; and a pump processor configured to alert the infusion pump when a command to prime is received and the male and female components are connected; The system includes: An eleventh aspect of the present invention is a method for manufacturing a semiconductor device comprising: 1. A method for preventing priming when a user is connected to an infusion pump, the method comprising: a pump processor receiving a command to prime; a pump processor determining whether the male and female components are connected; When the male and female components are connected, issuing an alarm to the user to prevent priming; allowing priming when the male and female components are not connected; The method includes: A twelfth aspect of the present invention is a method for manufacturing a semiconductor device comprising: A method according to an eleventh aspect, wherein the alarm is a visual alarm. A thirteenth aspect of the present invention is a method for manufacturing a semiconductor device comprising: A method according to a twelfth aspect, further comprising the alert being an audio alert. A fourteenth aspect of the present invention is a method for manufacturing a semiconductor device comprising: Aspect 13. The method of aspect 13, further comprising: the alert being a vibration alert. A fifteenth aspect of the present invention is a method for manufacturing a semiconductor device comprising: A method according to an eleventh aspect, wherein the alert is transmitted to a remote control.

Claims

[Claim 1] 1. A system for determining connection to a cannula, comprising: The system comprises: a male fitting connected to a piece of tubing; a female part fluidly connected to the cannula; an RFID chip attached to one of the male and female components; an antenna attached to the other of the male and female components; Including, The system is characterized in that the RFID chip and the antenna are used to determine whether the male and female components are connected and to transmit a signal regarding whether the male and female components are connected to an infusion pump via wireless communication.

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