US20140276536A1 - Infusion Pump System and Methods - Google Patents

Abstract

Some embodiments of an infusion pump system can provide an alarm and user instructions in response to an ambient air pressure change or ambient air temperature that exceeds an alarm limit parameter. In some circumstances, the infusion pump system can be configured to monitor the actual ambient air pressure and temperature around the infusion pump system.

Description

TECHNICAL FIELD
• This disclosure relates to portable infusion pump systems to deliver fluids, such as insulin infusion pump systems or the like.
BACKGROUND
• Pump devices are commonly used to deliver one or more fluids to a targeted individual. For example, a medical infusion pump device may be used to deliver a medicine to a patient as part of a medical treatment. The medicine that is delivered by the infusion pump device can depend on the condition of the patient and the desired treatment plan. For example, infusion pump devices have been used to deliver insulin to the vasculature of diabetes patients so as to regulate blood glucose levels.
• Ambient air pressure changes can have an effect on the operation of medical infusion pump devices. For example, in some circumstances an ambient air pressure reduction can initiate bubble formation in the liquid medicine within the pump device. The presence of bubbles in the medicine can thereafter negatively affect the accuracy of the medicine dispensations from the medical infusion pump or may cause air bubbles to be infused into the user.
• In some cases, ambient air temperatures changes can have a negative effect on the medicine dispensed by a medical infusion pump. For example, if insulin is exposed to freezing temperatures or temperatures substantially above body temperature for a particular period of time, the insulin can become less effective or otherwise require replacement.
SUMMARY
• Some embodiments of an infusion pump system can provide an alarm (e.g., an alert, a safety alarm, or the like) and initiate or suggest countermeasures in response to an ambient air pressure change or an ambient air temperature that exceeds an alarm limit parameter. In some circumstances, the infusion pump system can be configured to monitor the actual ambient air pressure and temperature around the infusion pump system. The infusion pump system can compare the actual ambient air pressure and temperature to alarm limits and provide an alarm when a limit is exceeded. In some circumstances, both “high” and “low” ambient air pressure and temperature alarm limits can be established.
• In particular embodiments described herein, a medical infusion pump system may include a portable pump housing that receives an insulin supply for dispensation to a user. The pump housing may at least partially contain a pump drive system to dispense insulin from the insulin supply through a flow path to the user. The system may also include a controller that communicates with the pump drive system to dispense the insulin from the portable pump housing. Optionally, the controller may include a user interface display device. The system may further include pressure detection device that communicates with the controller. The controller, in response to a detected ambient air pressure level being less than a lower threshold value or greater than a higher threshold value, can be configured to output an alarm and output a textual instruction via the user interface display indicative of maintaining the same insulin supply for subsequent dispensation.
• In some embodiments described herein, a medical infusion pump system includes a portable pump housing that receives insulin for dispensation to a user. The pump housing may at least partially contain a pump drive system to dispense the insulin through a flow path to the user. The system may further include a controller that communicates with the pump drive system to dispense the insulin from the portable pump housing. The system may also include a temperature detection device that communicates with the controller. The controller, in response to a detected temperature level being less than a lower threshold value or greater than a higher threshold value, can be configured to output an alarm.
• In various embodiments, a medical infusion pump system may include a portable pump housing defining an opening that slidably receives a prefilled cartridge of insulin for dispensation to a user. The pump housing may at least partially contain a pump drive system to dispense the insulin through a flow path to the user. The system may also include a controller that communicates with the pump drive system to dispense the insulin from the portable pump housing. The system may further include a detection device that communicates with the controller, and the detection device may be configured to detect an indicator on the prefilled cartridge of insulin that indicates whether the prefilled cartridge has sustained a particular temperature exposure level. The controller, in response to a detection of the indicator that the prefilled cartridge has sustained the particular temperature exposure level, may be configured to output an alarm.
• Particular implementations described herein include a method of operating an insulin infusion pump system. The method may include receiving, at a controller of an insulin infusion pump system, ambient air pressure information indicative of an ambient air pressure external of the insulin infusion pump system. The method may also include determining if the ambient air pressure information is less than a low limit threshold value or greater than a high limit threshold value. The low and high limit threshold values may be stored in the memory of the controller. The method may further include, in response to determining the ambient air pressure information is less than the low limit threshold value or greater than the high limit threshold value, outputting (i) an alarm and (ii) user instructions for continuing operations of the insulin infusion pump system without replacing an insulin supply and components of the infusion pump system.
• In some implementations described herein, a method of operating an insulin infusion pump system can include the step of receiving, at a controller of an insulin infusion pump system, temperature information indicative of a temperature at the insulin infusion pump system. The method may further include determining, by the controller, if the temperature information is less than a low limit threshold value or greater than a high limit threshold value. The low and high limit threshold values may be stored in the memory of the controller. The method may also include outputting, by the controller, an alarm in response to determining the temperature information is less than the lower threshold value or greater than the higher threshold value.
• In some embodiments described herein, a medical infusion pump system may include a portable pump housing that receives a medicine supply for dispensation to a user. The pump housing may at least partially contain a pump drive system to dispense medicine from the medicine supply through a flow path to the user. The system may also include a controller that communicates with the pump drive system to dispense the medicine from the portable pump housing. Furthermore, the system may include at least one of a pressure detection device and a temperature detection device configured to be coupled to the portable pump housing and to communicate with the controller.
• Some of the embodiments described herein may provide one or more of the following advantages. First, some embodiments of the infusion pump system can be configured to detect an ambient air pressure or ambient air temperature that exceeds an alarm limit parameter, and to thereafter provide readily understandable instructions (via a user interface) to the user for which types of corrective measures should be taken. For example, the user interface of the infusion pump system can be configured to output different instructions to the user depending on type of ambient pressure change or ambient air temperature that was detected.
• Second, some embodiments of the infusion pump system may provide an alert with instructions that prompts the user to take preventive or corrective actions that enable the user to maintain the efficacy of treatment provided by the infusion pump system. For example, in response to a “low” ambient air pressure (that induces a detection of a pressure drop) the infusion pump system may provide instructions to the user to inspect for bubbles in the medicine and to take a blood glucose measurement. Such infusion pump system features can be used advantageously to maintain the user's blood glucose level within a desired range despite the exposure of the infusion pump system to deviations in ambient conditions.
• Third, particular embodiments of an infusion pump system may prevent use of a medicine supply that may have deteriorated or otherwise become less effective. For example, in response to a “high” ambient air temperature the infusion pump system may provide instructions to the user to replace the medicine cartridge because the high temperature may have reduced the medicine's efficacy. In some circumstances, infusion pump system may prevent dispensation of the medicine that was subjected to the “high” ambient air temperature for an extended period of time.
• Fourth, the infusion pump system may be configured to be portable, wearable, and (in some circumstances) concealable. For example, a user can conveniently wear the infusion pump system on the user's skin under clothing or can carry the pump system in the user's pocket (or other portable location) while receiving the medicine dispensed from the pump device.
• The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims.
DESCRIPTION OF DRAWINGS
• FIG. 1 is a perspective view of an infusion pump system, in accordance with some embodiments.
• FIG. 2 is a perspective exploded view of an infusion pump assembly of the system ofFIG. 1.
• FIG. 3 is a perspective view of the infusion pump system ofFIG. 1 in which the pump assembly is worn on clothing of a user, in accordance with particular embodiments.
• FIG. 4 is a perspective view of an infusion pump system ofFIG. 1 in which the pump assembly is worn on skin of a user, in accordance with other embodiments.
• FIGS. 5-6 are perspective views of a pump device being detached from a controller device of the system ofFIG. 1, in accordance with some embodiments.
• FIGS. 7-8 are perspective views of the pump device ofFIGS. 5-6 being discarded and the controller device ofFIGS. 5-6 being reused with a new pump device.
• FIG. 9 is an exploded perspective view of a controller device for an infusion pump system, in accordance with some embodiments.
• FIG. 10 is a perspective view of a portion of a pump device for an infusion pump system, in accordance with particular embodiments.
• FIG. 11 is a perspective view of another example infusion pump system, in accordance with some embodiments.
• FIG. 12 is a flow diagram depicting an exemplary process for monitoring ambient air pressure and responding to alarm conditions, in accordance with some embodiments.
• FIG. 13 is a flow diagram depicting an exemplary process for monitoring ambient air temperature and responding to alarm conditions, in accordance with some embodiments.
• Like reference symbols in the various drawings indicate like elements.
DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS
• Referring toFIG. 1, aninfusion pump system10 can include apump assembly60 used to supply insulin or other medication to a user via, for example, an infusion set70. In some embodiments, theinfusion pump system10 can be configured to supply scheduled basal dosages of insulin (or other medication) along with user-selected bolus dosages. The basal rate can be selected to maintain a user's blood glucose level in a target range during normal activity when the user is not eating or otherwise consuming food items. The selected bolus deliveries may provide substantially larger amounts of insulin to limit the blood glucose level during certain circumstances, such as the consumption of carbohydrates and other food items (e.g., a “meal bolus”) or to lower an elevated glucose level (e.g., a “correction bolus”).
• In some embodiments, aglucose monitoring device50 can be in communication with theinfusion pump assembly60 for the purpose of supplying data indicative of a user's blood glucose level to acontroller device200 included in thepump assembly60. Theinfusion pump system10 can utilize the data indicative of a user's blood glucose level to, for example, provide an alarm (e.g., an audible or textual safety alarm, an audible or textual alert notification, or another type of alarm) when the user's blood glucose level falls below a low glucose alarm limit or rises above a high glucose alarm limit.
• In some embodiments, as described further below in connection withFIGS. 12 and 13, theinfusion pump system10 can monitor actual ambient conditions such as air pressure and temperature. In some such embodiments, theinfusion pump system10 can include anair pressure sensor250 and/or atemperature sensor260 that can measure the ambient pressure and temperature conditions respectively. Thepressure sensor250 andtemperature sensor260 can be in electrical communication with thecontroller device200. Thecontroller device200 can provide an alarm (e.g., an audible or textual safety alarm, an audible or textual alert notification, or another type of alarm) when the measured ambient conditions exceed predetermined alarm limits. In addition to alarming, in some embodiments thecontroller device200 can provide instructions for the user to take actions to counteract the potential negative effects that the ambient conditions may have on the accuracy of theinfusion pump system10. By implementing the instructions, the user's blood glucose level can be maintained within a desired range despite the exposure of theinfusion pump system10 to deviations in ambient conditions.
• Referring now toFIGS. 1-2, theinfusion pump assembly60 can include apump device100 and thecontroller device200 that communicates with thepump device100. Thepump device100 includes ahousing structure110 that defines acavity116 in which afluid cartridge120 can be received. Thepump device100 also includes acap device130 to retain thefluid cartridge120 in thecavity116 of thehousing structure110. Thepump device100 includes a drive system (described in more detail below in connection withFIG. 10) that advances aplunger125 in thefluid cartridge120 so as to dispense fluid therefrom. In some embodiments, the dispensed fluid exits thefluid cartridge120, passes through aflexible tube72 of the infusion set70 to acannula housing74. The dispensed fluid can enter through the skin via acannula76 attached to the underside of thecannula housing74.
• In some embodiments, thecontroller device200 communicates with thepump device100 to control the operation of the pump drive system. When thecontroller device200, the pump device100 (including thecap device130 in this embodiment), and thefluid cartridge120 are assembled together, the user may conveniently wear theinfusion pump assembly60 on the user's skin under clothing or in the user's pocket while receiving the fluid dispensed from the pump device100 (refer, for example, toFIGS. 3-4). Thus, in some embodiments, the pump assembly can operate as a portable unit that provides reliable delivery of insulin or another medication in a discrete manner.
• As described in more detail below, thecontroller device200 may be configured as a reusable component that provides electronics and a user interface to control the operation of thepump device100. In such circumstances, thepump device100 can be a disposable component that is disposed of after a single use. For example, thepump device100 can be a “one time use” component that is thrown away after thefluid cartridge120 therein is exhausted. Thereafter, the user can removably attach anew pump device100 to thereusable controller device200 for the dispensation of fluid from anew fluid cartridge120. Accordingly, the user is permitted to reuse the controller device200 (which may include complex or valuable electronics) while disposing of the relatively low-cost pump device100 after each use. Such apump assembly60 can provide enhanced user safety as a new pump device100 (and drive system therein) is employed with eachnew fluid cartridge120.
• Briefly, in use, thepump device100 can be configured to removably attach to thecontroller device200 in a manner that provides a secure fitting, an overall compact size, and a reliable electrical connection. The compact size permits theinfusion pump assembly60 to be discrete and portable. As described in more detail below, thecontroller device200 of the infusion pump system can be used to provide glucose alarms indicative of high and low blood glucose levels (when compared to predetermined high and low blood glucose alarm levels, respectively) and to provide alarms related to measured ambient conditions such as air pressure and temperature (when compared to predetermined high and low pressure and temperature alarm levels, respectively).
• It should be understood that, in alternative embodiments, thepump device100 and thecontroller device200 can be configured as a single unit in which the control components and the pump drive system are arranged in a single housing (refer, for example, toFIG. 11). In these alternative embodiments, the pump assembly (including the controller device and the pump device) may have a different size and shape and may operate as a reusable unit that can communicate with a number ofmonitoring devices50 over a period of time.
• Referring again toFIGS. 1-2, in some embodiments, thepump system10 is a medical infusion pump system that is configured to controllably dispense a medicine from thecartridge120. As such, thefluid cartridge120 may contain amedicine126 to be infused into the tissue or vasculature of a targeted individual, such as a human or animal patient. For example, thepump device100 can be adapted to receive amedicine cartridge120 in the form of a carpule that is preloaded with insulin or another medicine for use in the treatment of Diabetes (e.g., Byetta®, Symlin®, or others). Such acartridge120 may be supplied, for example, by Eli Lilly and Co. of Indianapolis, Ind. Other examples of medicines contained in thefluid cartridge120 include: medicines to treat primary immune deficiency (e.g., Vivaglobin® by CSL Behring of King of Prussia, Pa.), pain relief drugs, hormone therapy, blood pressure treatments, anti-emetics, osteoporosis treatments, or other injectable medicines.
• It should be understood from the description herein that thefluid cartridge120 may have a configuration other than that depicted inFIG. 2. For example, the fluid cartridge may have a different outer shape or a different reservoir volume. In another example, the fluid cartridge may comprise a reservoir that is integral with the pump housing structure110 (e.g., the fluid cartridge can be defined by one or more walls of thepump housing structure110 that surround a plunger to define a reservoir in which the medicine is injected or otherwise received).
• In some embodiments, thefluid cartridge120 may include features for indicating if thefluid cartridge120 has been exposed to environmental conditions that may have reduced the efficacy of the contents. The basis for such features is the fact that high or low temperatures may reduce the effectiveness or potency of the medicine. Insulin, for example, may become tainted (less effective than normal) as a result of exposure to temperatures at or below freezing (about 0 degrees Celsius), or temperatures at or above human body temperatures (about 37 degrees Celsius). Therefore, an allowed temperature range for insulin can, in some cases, be from about 0 degrees to about 37 degrees Celsius. Other medicines may have other allowed temperature ranges. If the temperature indicators on thefluid cartridge120 indicate that temperature limits have been exceeded, thefluid cartridge120 can be discarded by the user or, in some embodiments, prevented from use by theinfusion pump system10.
• In some embodiments, thefluid cartridge120 can include one or more temperature sensitive ink labels123 on the surface of thefluid cartridge120, or on the packaging materials for thefluid cartridge120. In some such embodiments, the temperature sensitive ink labels123 can indicate whether thefluid cartridge120 has been exposed to high or low temperature conditions that may have reduced the effectiveness or potency of the medicine. In some embodiments, the temperature sensitive ink, which may be in the form of a barcode in some embodiments, will become visually altered (e.g., the ink will become visible, or will become darkened, or will change color) in response to exceeding a high temperature limit or falling below a low temperature limit. In such cases, the user can visually perceive that the temperature sensitive ink labels123 indicate that thefluid cartridge120 has gone out of the allowed temperature range, and the user can discard the potentially taintedfluid cartridge120 prior to installing it apump device100.
• In some embodiments, theinfusion pump system10 can include anoptical sensor115 to detect the status of the temperature sensitive ink labels123. Theoptical sensor115 can be in electrical communication with thecontroller device200. If theoptical sensor115 in conjunction with thecontroller device200 detects an indication by the temperature sensitive ink labels123 that thefluid cartridge120 has gone out of the allowed temperature range, in some embodiments theinfusion pump system10 can initiate appropriate action such as providing an alarm, providing a message to the user, and ceasing dispensations of the medicine from the suspectfluid cartridge120. In some embodiments, theoptical sensor115 can provide an initial detection of the temperature sensitive ink labels123 when thepump device100 containing thefluid cartridge120 is first coupled with thecontroller device200. In some embodiments, theoptical sensor115 can provide on-going monitoring of the temperature sensitive ink labels123 while theinfusion pump system10 is in use. In some embodiments, both the initial detection and the on-going monitoring of the temperature sensitive ink labels123 can be performed by theoptical sensor115 in conjunction with thecontroller device200.
• In some embodiments, thepump device100 may include one or more structures that interfere with the removal of themedicine cartridge120 after themedicine cartridge120 is inserted into thecavity116. For example, as shown inFIG. 2, thepump housing structure110 may include one ormore retainer wings119 that at least partially extend into thecavity116 to engage a portion of themedicine cartridge120 when themedicine cartridge120 is installed therein. In this embodiment, thepump housing structure110 includes a pair of opposing retainer wings119 (only one is shown in the view inFIG. 2) that flex toward the inner surface of thecavity116 during insertion of themedicine cartridge120. After the medicine cartridge is inserted to a particular depth, theretainer wings119 are biased to flex outward (toward the center of the cavity116) so that theretainer wings119 engage aneck portion129 of themedicine cartridge120. This engagement with theretainer wings119 and theneck portion129 hinder any attempts to remove themedicine cartridge120 away from thepump device100. Alternative embodiments can include other features and/or configurations to hinder the removal of themedicine cartridge120.
• Embodiments of thepump device100 that hinder the removal of themedicine cartridge120 may facilitate the “one-time-use” feature of thepump device100. Because theretainer wings119 can interfere with attempts to remove themedicine cartridge120 from thepump device100, thepump device100 will be discarded along with themedicine cartridge120 after themedicine cartridge120 is emptied, expired, or otherwise exhausted. Theretainer wings119 may serve to hinder attempts to remove the exhaustedmedicine cartridge120 and to insert anew medicine cartridge120 into the previously usedpump device100. Accordingly, thepump device100 may operate in a tamper-resistant and safe manner because thepump device100 can be designed with predetermined life expectancy (e.g., the “one-time-use” feature in which the pump device is discarded after themedicine cartridge120 is emptied, expired, or otherwise exhausted).
• Still referring toFIGS. 1-2, thecap device130 can be joined with thepump device100 after the medicine cartridge is inserted in thecavity116. It should be understood that thecap device130 may supplement or replace the previously describedretainer wings119 by locking into position after joining with thepump housing110, thereby hindering removal of thefluid cartridge120 in thepump housing110. As shown inFIGS. 1-2, thecap device130 may include anoutput port139 that connects with thetubing72 for dispensation of the medicine to the user. In some embodiments, theoutput port139 may have an angled orientation such that a portion of the tubing extends transversely to the central axis of thecartridge120 andcap device130. Theoutput port139 can be configured to mate withtubing72 of the infusion set70 (FIG. 1).
• In some embodiments, thecontroller device200 may be removably attached to thepump device100 so that the two components are mechanically mounted to one another in a fixed relationship. Such a mechanical mounting can form an electrical connection between theremovable controller device200 and thepump device100. For example, thecontroller device200 may be in electrical communication with a portion of a drive system (described in connection withFIG. 10) of thepump device100. As described in more detail below, thepump device100 includes a drive system that causes controlled dispensation of the medicine or other fluid from thecartridge120. In some embodiments, the drive system incrementally advances a piston rod longitudinally into thecartridge120 so that the fluid is forced out of anoutput end122. Theseptum121 at theoutput end122 of thefluid cartridge120 can be pierced to permit fluid outflow when thecap device130 is connected to thepump housing structure110. Thus, when thepump device100 and thecontroller device200 are attached and thereby electrically connected, thecontroller device200 communicates electronic control signals via a hardwire-connection (e.g., electrical contacts or the like) to the drive system or other components of thepump device100. In response to the electrical control signals from thecontroller device200, the drive system of thepump device100 causes medicine to incrementally dispense from themedicine cartridge120.
• Thecontroller device200 may be configured to removably attach to thepump device100, for example, in a side-by-side arrangement. The compact size permits theinfusion pump assembly60 to be discrete and portable when thepump device100 is attached with the controller device200 (as shown inFIG. 1). In this embodiment, thecontroller device200 includes acontroller housing structure210 having a number of features that are configured to mate with complementary features of thepump housing structure110 so as to form a releasable mechanical connection (described below in more detail in connection withFIGS. 5-7). Such mating features of thepump housing structure110 and thecontroller housing structure210 can provide a secure connection when thecontroller device200 is attached to thepump device100
• As shown inFIG. 2, thepump device100 may include an electrical connector118 (e.g., having conductive pads, pins, or the like) that are exposed to thecontroller device200 and that mate with a complementary electrical connector (refer toconnector218 inFIG. 6) on the adjacent face of thecontroller device200. Theelectrical connectors118 and218 provide the electrical communication between the control circuitry (refer, for example, toFIG. 9) housed in thecontroller device200 and at least a portion of the drive system or other components of thepump device100. In some exemplary embodiments, theelectrical connectors118 and218 permit the transmission of electrical control signals to thepump device100 and the reception of feedback signals (e.g., sensor signals) from particular components within thepump device100. Furthermore, as described in more detail below, theinfusion pump assembly60 may include agasket140 that provides a seal which is resistant to migration of external contaminants when thepump device100 is attached to thecontroller device200. Thus, in some embodiments, thepump device100 and thecontroller device200 can be assembled into a water resistant configuration that protects the electrical interconnection from water migration (e.g., if the user encounters water while carrying the pump assembly60).
• Referring again toFIGS. 1-2, thecontroller device200 includes theuser interface220 that permits a user to monitor the operation of thepump device100. In some embodiments, theuser interface220 includes adisplay222 and one or more user-selectable buttons (e.g., fourbuttons224a,224b,224c, and224din this embodiment). Thedisplay222 may include an active area in which numerals, text, symbols, images, or a combination thereof can be displayed. For example, thedisplay222 may be used to communicate a number of status indicators, alarms, settings, and/or menu options for theinfusion pump system10. In some embodiments, thedisplay222 can present alarms related to various detected ambient conditions such as: a high or low ambient air pressure status; a high or low ambient temperature status; rising or falling ambient pressure or temperature levels (e.g., a noteworthy change in pressure or temperature), or any combination thereof. In the example depicted inFIG. 1, thedisplay222 indicates an alert in which thecontroller device200 has sensed a low ambient air pressure (below a predetermined threshold level). In this embodiment, thedisplay222 also prompts the user to take particular countermeasures (as described further in reference toFIGS. 12 and 13), such as inspecting for bubbles and checking blood glucose, thereby helping the user to maintain blood glucose levels within the normal range.
• In some embodiments, the user may press one or more of thebuttons224a,224b,224c, and224dto shuffle through a number of menus or program screens that show particular status indicators, settings, and/or data (e.g., review data that shows the medicine dispensing rate, the total amount of medicine dispensed in a given time period, the amount of medicine scheduled to be dispensed at a particular time or date, the approximate amount of medicine remaining in thecartridge120, or the like). In some embodiments, the user can adjust the settings or otherwise program thecontroller device200 by pressing one ormore buttons224a,224b,224c, and224dof theuser interface220. For example, in embodiments of theinfusion pump system10 configured to dispense insulin, the user may press one or more of thebuttons224a,224b,224c, and224dto change the dispensation rate of insulin or to request that a bolus of insulin be dispensed immediately or at a scheduled, later time.
• Thedisplay222 of theuser interface220 may be configured to display alarm information when nobuttons224a,224b,224c, and224dhave been pressed. For example, as shown inFIG. 1, the active area of thedisplay222 can display an alert indicating that thepressure sensor250 of thecontroller device200 has detected a low ambient air pressure (below a predetermined threshold level). This information can be displayed until one of thebuttons224a,224b,224c, and224dhas been actuated. This, or other, information can also be displayed for a period of time after nobutton224a,224b,224c, and224dhas been actuated (e.g., five seconds, 10 seconds, 30 seconds, 1 minute, 5 minutes, or the like). Thereafter, thedisplay222 may enter sleep mode in which the active area is blank, thereby conserving battery power. In addition or in the alternative, the active area can display particular device settings, such as the current dispensation rate or the total medicine dispensed, for a period of time after nobutton224a,224b,224c, or224dhas been actuated (e.g., five seconds, 10 seconds, 30 seconds, 1 minute, 5 minutes, or the like). Again, thereafter thedisplay222 may enter sleep mode to conserve battery power. In certain embodiments, thedisplay222 can dim after a first period of time in which nobutton224a,224b,224c, or224dhas been actuated (e.g., after 15 seconds or the like), and then thedisplay22 can enter sleep mode and become blank after a second period of time in which nobutton224a,224b,224c, or224dhas been actuated (e.g., after 30 seconds or the like). Thus, the dimming of thedisplay device222 can alert a user viewing thedisplay device222 when the active area223 of the display device will soon become blank.
• Accordingly, when thecontroller device200 is connected to thepump device100, the user is provided with the opportunity to readily monitor infusion pump operation by simply viewing thedisplay222 of thecontroller device200. Such monitoring capabilities may provide comfort to a user who may have urgent questions about the current operation of the pump device100 (e.g., the user may be unable to receive immediate answers if wearing an infusion pump device having no user interface attached thereto). Moreover, the ambient condition alerts can be displayed contemporaneously with the detected blood glucose value, so the user is provided with the opportunity to make informed decisions regarding the current and future status of his or her blood glucose level.
• Also, in these embodiments, there may be no need for the user to carry and operate a separate module to monitor the operation of theinfusion pump device100, thereby simplifying the monitoring process and reducing the number of devices that must be carried by the user. If a need arises in which the user desires to monitor the operation of thepump device100 or to adjust settings of the pump system10 (e.g., to request a bolus amount of medicine), the user can readily operate theuser interface220 of thecontroller device200 without the requirement of locating and operating a separate monitoring module.
• In other embodiments, theuser interface200 is not limited to the display and buttons depicted inFIGS. 1-2. For example, in some embodiments, theuser interface220 may include only one button or may include a greater numbers of buttons, such as two buttons three buttons, four buttons, five buttons, or more. In another example, theuser interface220 of thecontroller device200 may include a touch screen so that a user may select buttons defined by the active area of the touch screen display. Alternatively, theuser interface220 may comprise audio inputs or outputs so that a user can monitor the operation of thepump device100.
• Referring toFIGS. 3-4, theinfusion pump system10 may be configured to be portable and can be wearable and concealable. For example, a user can conveniently wear theinfusion pump assembly60 on the user's skin (e.g., skin adhesive) underneath the user's clothing or carry thepump assembly60 in the user's pocket (or other portable location) while receiving the medicine dispensed from thepump device100. Thepump device100 may be arranged in a compact manner so that thepump device100 has a reduced length. For example, in the circumstances in which themedicine cartridge120 has a length of about 7 cm or less, about 6 cm to about 7 cm, and about 6.4 cm in one embodiment, the overall length of the pump housing structure110 (which contains medicine cartridge and the drive system) can be about 10 cm or less, about 7 cm to about 9 cm, and about 8.3 cm in one embodiment. In such circumstances, thecontroller device200 can be figured to mate with thepump housing110 so that, when removably attached to one another, the components define a portable infusion pump system that stores a relatively large quantity of medicine compared to the overall size of the unit. For example, in this embodiment, the infusion pump assembly60 (including theremovable controller device200 attached to thepump device100 having the cap130) may have an overall length of about 11 cm or less, about 7 cm to about 10 cm, and about 9.6 cm in one embodiment; an overall height of about 6 cm or less, about 2 cm to about 5 cm, and about 4.3 cm in one embodiment; and an overall thickness of about 20 mm or less, about 8 mm to about 20 mm, and about 18.3 mm in one embodiment.
• Thepump system10 is shown inFIGS. 3-4 is compact so that the user can wear the portable infusion pump system10 (e.g., in the user's pocket, connected to a belt clip, adhered to the user's skin, or the like) without the need for carrying and operating a separate module. In such embodiments, thecap device130 of thepump device100 may be configured to mate with the infusion set70. In general, the infusion set70 is tubing system that connects theinfusion pump system10 to the tissue or vasculature of the user (e.g., to deliver medicine into the user's subcutaneous tissue or vasculature). The infusion set70 may include theflexible tube72 that extends from thepump device100 to thesubcutaneous cannula76 retained by askin adhesive patch78 that secures thesubcutaneous cannula76 to the infusion site. Theskin adhesive patch78 can retain theinfusion cannula76 in fluid communication with the tissue or vasculature of the patient so that the medicine dispensed through thetube72 passes through thecannula76 and into the user's body. Thecap device130 may provide fluid communication between the output end122 (FIG. 2) of themedicine cartridge120 and thetube72 of the infusion set70. For example, thetube72 may be directly connected to the output port139 (FIG. 2) of thecap device130. In another example, the infusion set70 may include a connector (e.g., a Luer connector or the like) attached to thetube72, and the connector can then mate with thecap device130 to provide the fluid communication to thetube72. In these examples, the user can carry the portable infusion pump assembly60 (e.g., in the user's pocket, connected to a belt clip, adhered to the user's skin, or the like) while thetube72 extends to the location in which the skin is penetrated for infusion. If the user desires to monitor the operation of thepump device100 or to adjust the settings of theinfusion pump system10, the user can readily access theuser interface220 of thecontroller device200 without the need for carrying and operating a separate module.
• Referring toFIG. 3, in some embodiments, theinfusion pump assembly60 is pocket-sized so that thepump device100 andcontroller device200 can be worn in the user'spocket6 or in another portion of the user's clothing. For example, thepump device100 and thecontroller device200 can be attached together and form theassembly60 that comfortably fits into a user'spocket6. The user can carry the portableinfusion pump assembly60 and use thetube72 of the infusion set70 to direct the dispensed medicine to the desired infusion site. In some circumstances, the user may desire to wear thepump assembly60 in a more discrete manner. Accordingly, the user may pass thetube72 from thepocket6, under the user's clothing, and to the infusion site where theadhesive patch78 is positioned. As such, thepump system10 can be used to deliver medicine to the tissues or vasculature of the user in a portable, concealable, and discrete manner. Furthermore, themonitoring device50 can be worn on the user's skin while thepump assembly60 is carried by the user (e.g., in a pocket). As such, themonitoring device50 can communicate information indicative of the user's blood glucose level to thepump assembly60 while thepump assembly60 is used to deliver medicine through the infusion set70. In this embodiment, themonitoring device50 may be arranged on the user's skin at a location that is spaced apart from the infusion set70.
• Referring toFIG. 4, in other embodiments, theinfusion pump assembly60 may be configured to adhere to the user's skin7 directly at the location in which the skin is penetrated for medicine infusion. For example, a rear surface of thepump device100 may include a skin adhesive patch so that thepump device100 is physically adhered to the skin of the user at a particular location. In these embodiments, thecap device130 may have a configuration in which medicine passes directly from thecap device130 into aninfusion cannula76 that is penetrated into the user's skin. In one example, thefluid output port139 through thecap device130 can include a curve or a 90° corner so that the medicine flow path extends longitudinally out of the medicine cartridge and thereafter laterally toward the patient's skin7. Again, if the user desires to monitor the operation of thepump device100 or to adjust the settings of theinfusion pump system10, the user can readily access theuser interface220 of thecontroller device200 without the need for carrying and operating a second, separate device. For example, the user may look toward thepump device100 to view theuser interface220 of thecontroller device200 that is removably attached thereto. In another example, the user can temporarily detach the controller device200 (while thepump device100 remains adhered to the skin7) so as to view and interact with theuser interface220. Furthermore, themonitoring device50 can be worn on the user's skin while thepump assembly60 is worn on the user's skin in a different location from that where the monitoring device is worn. As such, themonitoring device50 can communicate information indicative of the user's blood glucose level to thepump assembly60 while thepump assembly60 is used to deliver medicine through the infusion set70. In this embodiment, themonitoring device50 may be arranged on the user's skin at a location that is spaced apart from the infusion set70.
• In the embodiments depicted inFIGS. 3-4, themonitoring device50 adheres to the user's skin7 at the location in which the skin is penetrated by the sensor shaft56 (to detect blood glucose levels). The sensor shaft56 (refer toFIG. 1) penetrates the skin surface for the purpose of exposing the tip portion of thesensor shaft56 to the tissue or the vasculature of the user. Thesensor shaft56 can detect information indicative of the user's blood glucose level and transfer this information to a circuit that is connected to thecommunications device54 located within themonitoring device50. Thecommunication device54 can be in wireless communication with the communication device247 (described in connection withFIG. 9) included in thecontroller device200 of thepump assembly60.
• Referring now toFIGS. 5-8, in some embodiments, theinfusion pump assembly60 can be operated such that thepump device100 is a disposable, non-reusable component while thecontroller device200 is a reusable component. In these circumstances, thepump device100 may be configured as a “one-time-use” device that is discarded after the medicine cartridge is emptied, expired, or otherwise exhausted. Thus, in some embodiments, thepump device100 may be designed to have an expected operational life of about 1 day to about 30 days, about 1 day to about 20 days, about 1 to about 14 days, or about 1 day to about 7 days—depending on the volume of medicine in thecartridge120, the dispensation patterns that are selected for the individual user, and other factors. For example, in some embodiments, themedicine cartridge120 containing insulin may have an expected usage life about 7 days after the cartridge is removed from a refrigerated state and the septum121 (FIG. 2) is punctured. In some circumstances, the dispensation pattern selected by the user can cause the insulin to be emptied from themedicine cartridge120 before the 7-day period. If the insulin is not emptied from themedicine cartridge120 after the 7-day period, the remaining insulin may become expired sometime thereafter. In either case, thepump device100 and themedicine cartridge120 therein can be discarded after exhaustion of the medicine cartridge120 (e.g., after being emptied, expired, or otherwise not available for use).
• Thecontroller device200, however, may be reused with subsequentnew pump devices100′ andnew medicine cartridges120′. As such, the control circuitry, the user interface components, and other components that may have relatively higher manufacturing costs can be reused over a longer period of time. For example, in some embodiments, thecontroller device200 may be designed to have an expected operational life of about 1 year to about 7 years, about 2 years to about 6 years, or about 3 years to about 5 years—depending on a number of factors including the usage conditions for the individual user. Accordingly, the user is permitted to reuse the controller device200 (which may include complex or valuable electronics) while disposing of the relatively low-cost pump device100 after each use. Such apump system10 can provide enhanced user safety as anew pump device100′ (and drive system therein) is employed with eachnew fluid cartridge120.
• Referring toFIGS. 5-6, thepump device100 can be readily removed from thecontroller device200 when themedicine cartridge120 is exhausted. As previously described, themedicine cartridge120 is arranged in the cavity116 (FIG. 2) of thepump housing110 where it is retained by thecap device130. In some embodiments, a portion of thepump housing110 can comprise a transparent or translucent material so that at least a portion of themedicine cartridge120 is viewable therethrough. For example, the user may want to visually inspect the medicine cartridge when theplunger125 is approaching theoutput end122 of the medicine cartridge, thereby providing a visual indication that the medicine cartridge may be emptied in the near future. In this embodiment, thebarrel111 of thepump housing110 comprises a generally transparent polymer material so that the user can view themedicine cartridge120 to determine if theplunger125 is nearing the end of its travel length.
• As shown inFIG. 5, thepump device100 has been used to a point at which themedicine cartridge120 is exhausted. Theplunger125 has been advanced, toward the left inFIG. 5, over a period of time so that all or most of the medicine has been dispensed from thecartridge120. In some embodiments, thecontroller device200 may provide a visual or audible alert when this occurs so as to remind the user that a new medicine cartridge is needed. In addition or in the alternative, the user may visually inspect themedicine cartridge120 through thebarrel111 of thepump housing110 to determine if themedicine cartridge120 is almost empty. When the user determines that anew medicine cartridge120 should be employed, thepump device100 can be readily separated from thecontroller device200 by actuating arelease member215. In this embodiment, therelease member215 is a latch on thecontroller device200 that is biased toward a locking position to engage thepump device100. The latch may be arranged to engage one or more features on a lateral side of thepump housing110. As such, the user may actuate therelease member215 by moving therelease member215 in a lateral direction216 (FIG. 5) away from the pump device100 (e.g., by applying a force with the user's finger).
• As shown inFIG. 6, when therelease member215 is actuated and moved to a position away from thepump device100, a segmented guide rail114a-bis free to slide longitudinally in a guide channel214a-bwithout interference from therelease member215. Accordingly, the user can move thepump device100 in alongitudinal direction217 away from thecontroller device200. For example, the segmented guide rail114a-bmay slide along the guide channel214a-b, the extension113 (FIG. 2) may be withdrawn from the mating depression213 (FIG. 6), and theelectrical connector118 can be separated from themating connector218. In these circumstances, thepump device100 is physically and electrically disconnected from thecontroller device200 while the pump device retains the exhaustedmedicine cartridge120. It should be understood that, in other embodiments, other features or connector devices can be used to facilitate the side-by-side mounting arrangement. These other features or connector devices may include, for example, magnetic attachment devices, mating tongues and grooves, or the like.
• In some embodiments, thegasket140 compressed between thepump device100 and thecontroller device200 may comprise a resilient material. In such circumstances, thegasket140 can provide a spring-action that urges thepump device100 to shift a small amount away from thecontroller device200 when therelease member215 is moved to the unlocked position (e.g., moved in thelateral direction216 in the embodiment shown inFIG. 5). Accordingly, in some embodiments, thepump device100 can automatically and sharply move a small distance (e.g., about 0.5 mm to about 5 mm) away from thecontroller device200 when therelease member215 is moved to the unlocked position. Such an automatic separation provides a convenient start for the user to detach thepump device100 away from thecontroller device200. Furthermore, this automatic separation caused by the spring-action of thegasket140 can provide a swift disconnect between theelectrical connectors118 and218 when thepump device100 is being replaced.
• Referring toFIGS. 7-8, thesame controller device200 can be reused with anew pump device100′ having anew medicine cartridge120′ retained therein, and the previously usedpump device100 can be discarded with the exhaustedmedicine cartridge120. Thenew pump device100′ (FIG. 7) can have a similar appearance, form factor, and operation as the previously used pump device100 (FIGS. 5-6), and thus thenew pump device100′ can be readily attached to thecontroller device200 for controlled dispensation of medicine from thenew medicine cartridge120′. In some embodiments, the user may prepare thenew pump device100′ for use with thecontroller device200. For example, the user may insert thenew medicine cartridge120′ in thecavity116 of thenew pump device100′ and then join thecap device130 to the pump housing to retain thenew medicine cartridge120′ therein (refer, for example, toFIG. 2). Although thetubing72 of the infusion set70 is not shown inFIG. 7, it should be understood that thetubing72 may be attached to thecap device130 prior to thecap device130 being joined with thehousing110. For example, a new infusion set70 can be connected to thecap device130 so that thetubing72 can be primed (e.g., a selected function of thepump device100 controlled by the controller device200) before attaching the infusion set patch to the user's skin. As shown inFIG. 7, thenew medicine cartridge120′ may be filled with medicine such that theplunger125 is not viewable through thebarrel111. In some embodiments, the user can removably attach thepump device100 to thecontroller device200 by moving thepump device100 in alongitudinal direction219 toward thecontroller device200 such that the segmented guide rail114a-bengages and slides within the guide channel214a-b. When theelectrical connectors118 and218 mate with one another, therelease member215 can engage the segmented guide rails114a-bto retain thepump device100 with thecontroller device200.
• As shown inFIG. 8, the previously usedpump device100 that was separated from the controller device (as described in connection withFIGS. 5-6) may be discarded after a single use. In these circumstances, thepump device100 may be configured as a disposable “one-time-use” device that is discarded by the user after themedicine cartridge120 is emptied, is expired, has ended its useful life, or is otherwise exhausted. For example, thepump device100 may be discarded into a bin30, which may include a trash bin or a bin specifically designated for discarded medical products. Thus, the user is permitted to dispose of the relatively low-cost pump device100 after each use while reusing the controller device200 (which may include complex or valuable electronics) with subsequentnew pumps100′. Also, in some circumstances, the infusion set70 (not shown inFIG. 8, refer toFIG. 1) that was used with thepump device100 may be removed from the user and discarded into the bin30 along with thepump device100. Alternatively, the infusion set70 can be disconnected from theprevious pump device100 and attached to thenew pump device100′. In these circumstances, the user may detach the infusion setcannula76 andpatch78 from the skin so as to “re-prime” the tubing with medicine from thenew pump device100′ to remove air pockets from the tubing. Thereafter, the infusion setcannula76 andpatch78 can be again secured to the user's skin.
• Referring now toFIG. 9, the controller device200 (shown in an exploded view) houses a number of components that can be reused with a series ofsuccessive pump devices100. In particular, thecontroller device200 includescontrol circuitry240 arranged in thecontroller housing210 that is configured to communicate control signals to the drive system of thepump device100. In this embodiment, thecontrol circuitry240 includes amain processor board242 that is in communication with apower supply board244. Thecontrol circuitry240 includes at least oneprocessor243 that coordinates the electrical communication to and from the controller device200 (e.g., communication between thecontroller device200 and the pump device100). Theprocessor243 can be arranged on themain processor board242 along with a number of other electrical components such as memory devices (e.g., memory chip248). It should be understood that, although themain processor board242 is depicted as a printed circuit board, the main processor board can have other forms, including multiple boards, a flexible circuit substrate, and other configurations that permit theprocessor243 to operate. Thecontrol circuitry240 can be programmable in that the user may provide one or more instructions to adjust a number of settings for the operation of theinfusion pump system10. Such settings may be stored in the one or more memory devices, such as thememory chip248 on theprocessor board242. Thecontrol circuitry240 may include other components, such as sensors (e.g., occlusion sensors, ambient air pressure sensors, temperature sensors), that are electrically connected to themain processor board242. For example, in some embodiments theprocessor board242 includes the ambient air pressure sensor250 (e.g., barometric sensor, altimeter, GPS, potentiometric sensor, capacitive sensor, piezoelectric sensor, strain gauge sensor, etc.) and/or the temperature sensor260 (e.g., thermistor, thermocouple, resistance temperature detector, etc.). In some embodiments, such sensors are mounted directly on theprocessor board242. In other embodiments, such sensors are mounted on one or more auxiliary circuit boards that are in electrical communication with theprocessor board242. In further embodiments, such sensors are remotely located from theprocessor board242 and are in communication with theprocessor board242 by hard-wiring. In alternative embodiments, such sensors are remotely located from theprocessor board242 and are in communication with theprocessor board242 by wireless communication (e.g., RF, infrared, Bluetooth, etc.). In some embodiments, such sensors may be located within the housings of thepump device100 or thecontroller device200. In other embodiments, such sensors may be located outside of the housings of thepump device100 or thecontroller device200. Furthermore, thecontrol circuitry240 may include one or more dedicated memory devices that store executable software instructions for theprocessor243. The one or more memory devices (e.g., the memory chip248) can also store information related to a user's blood glucose level and total insulin load (described in more detail in association withFIGS. 11-16B) over a period of time.
• As previously described, thecontroller device200 can be electrically connected with thepump device100 viamating connectors118 and218 so that thecontrol circuitry240 can communicate control signals to thepump device100 and receive feedback signals from components housed in thepump device100. In this embodiment, the electrical connector118 (FIG. 2) on thepump device100 is a z-axis connector, and the connector218 (FIG. 6) on thecontroller device200 is adapted to mate therewith. Theelectrical connector218 on thecontroller device200 is in communication with thecontrol circuitry240. As such, theprocessor243 can operate according to software instructions stored in the memory device so as to send control signals to thepump device100 via theconnector218.
• Still referring toFIG. 9, theuser interface220 of thecontroller device200 can include input components, output components, or both that are electrically connected to thecontrol circuitry240. For example, in this embodiment, theuser interface220 includes adisplay device222 having an active area that outputs information to a user and four buttons224a-dthat receive input from the user. Here, thedisplay222 may be used to communicate a number of status indicators, settings, and/or menu options for theinfusion pump system10. In some embodiments, thecontrol circuitry240 may receive the input commands from the user's button selections and thereby cause thedisplay device222 to output a number of status indicators (e.g., if thepump system10 is delivering insulin, if the user's blood glucose level is rising or falling, and the like), menus, and/or program screens that show particular settings and data (e.g., the user's blood glucose level, the user's insulin load, the user's TIL % value, or the like). As previously described, thecontroller circuit240 can be programmable in that the input commands from the button selections can cause thecontroller circuit240 to change any one of a number of settings for theinfusion pump system100.
• Some embodiments of thecontrol circuitry240 may include a cable connector (e.g., a USB connection port, another data cable port, or a data cable connection via the electrical connection218) that is accessible on an external portion of thecontroller housing210. As such, a cable may be connected to thecontrol circuitry240 to upload data or program settings to the controller circuit or to download data from thecontrol circuitry240. For example, historical data of blood glucose level, blood glucose alarm limits (including notification alert limits and safety alarm limits), medicine delivery (including basal and bolus deliveries), and/or TIL information can be downloaded from the control circuitry240 (via the cable connector) to a computer system of a physician or a user for purposes of analysis and program adjustments. Optionally, the data cable may also provide recharging power.
• Referring toFIGS. 9-10, thecontrol circuitry240 of thecontroller device200 may include a second power source245 (FIG. 9) that can receive electrical energy from a first power source345 (FIG. 10) housed in thepump device100. In this embodiment, thesecond power source245 is coupled to thepower supply board244 of thecontrol circuitry240. The hard-wired transmission of the electrical energy can occur through the previously describedconnectors118 and218. In such circumstances, thefirst power source345 may include a high density battery that is capable of providing a relatively large amount of electrical energy for its package size, while thesecond power source245 may include a high current-output battery that is capable discharging a brief current burst to power thedrive system300 of thepump device100. Accordingly, thefirst battery345 disposed in thepump device100 can be used to deliver electrical energy over time (e.g., “trickle charge”) to thesecond battery245 when thecontroller device200 is removably attached to thepump device100. For example, thefirst battery345 may comprise a zinc-air cell battery. The zinc-air cell battery345 may have a large volumetric energy density compared to some other battery types. Also, the zinc-air cell battery may have a long storage life, especially in those embodiments in which the battery is sealed (e.g., by a removable seal tab or the like) during storage and before activation.
• Thesecond battery245 may include a high current-output device that is housed inside thecontroller housing210. Thesecond battery245 can be charged over a period of time by thefirst battery345 and then intermittently deliver bursts of high-current output to thedrive system300 over a brief moment of time. For example, thesecond battery245 may comprise a lithium-polymer battery. The lithium-polymer battery245 disposed in thecontroller device200 may have an initial current output that is greater than the zinc-air cell battery345 disposed in thepump device100, but zinc-air cell battery345 may have an energy density that is greater than the lithium-polymer battery245. In addition, the lithium-polymer battery245 is readily rechargeable, which permits the zinc-air battery345 disposed in thepump device100 to provide electrical energy to the lithium-polymer battery245 for purposes of recharging. In alternative embodiments, it should be understood that thesecond power source245 may comprise a capacitor device capable of being recharged over time and intermittently discharging a current burst to activate the drive system105.
• Accordingly, theinfusion pump system10 having twopower sources345 and245—one arranged in thepump device100 and another arranged in thereusable controller device200—permits a user to continually operate thecontroller device200 without having to recharge a battery via an outlet plug-in or other power cable. Because thecontroller device200 can be reusable with a number of pump devices100 (e.g., attach thenew pump device100′ after theprevious pump device100 is expended and disposed), thesecond power source245 in the controller device can be recharged over a period of time each time anew pump device100 is connected thereto. Such a configuration can be advantageous in those embodiments in which thepump device100 is configured to be a disposable, one-time-use device that attaches to areusable controller device200. For example, in those embodiments, the “disposable”pump devices100 recharge thesecond power source245 in the “reusable”controller device200, thereby reducing or possibly eliminating the need for separate recharging of thecontroller device200 via a power cord plugged into a wall outlet.
• Referring now toFIG. 10, thepump device100 in this embodiment includes thedrive system300 that is controlled by the removable controller device200 (seeFIG. 2). Accordingly, thedrive system300 can accurately and incrementally dispense fluid from thepump device100 in a controlled manner. Thedrive system300 may include aflexible piston rod370 that is incrementally advanced toward themedicine cartridge120 so as to dispense the medicine from thepump device100. At least a portion of thedrive system300 is mounted, in this embodiment, to thepump housing110. Some embodiments of thedrive system300 may include a battery powered actuator (e.g.,reversible motor320 or the like) that actuates agear system330 to reset a ratchet mechanism (e.g., including a ratchet wheel and pawl), a spring device (not shown) that provides the driving force to incrementally advance the ratchet mechanism, and adrive wheel360 that is rotated by the ratchet mechanism to advance theflexible piston rod370 toward themedicine cartridge120. Connected topiston rod370 is apusher disc375 for moving theplunger125 of themedicine cartridge120.
• Some embodiments of thedrive system300 can include apressure sensor380 disposed between theplunger engagement device375 and theplunger125 for determining the pressure within the fluid path (e.g., inside themedicine cartridge120, the infusion set70, and the like). For example, the fluid pressure in themedicine cartridge120 can act upon theplunger125, which in turn can act upon thepressure sensor380 arranged on the dry side of theplunger125. Thepressure sensor380 may comprise a pressure transducer that is electrically connected (via one or more wires) to agateway circuit318 so that the sensor signals can be communicated to the controller device200 (e.g., via theelectrical connectors118 and218). As such, data from thepressure sensor380 can be received by thecontroller device200 for use with, for example, an occlusion detection module to determine if an occlusion exists in the medicine flow path. Alternatively, thecontroller device200 may include an optical sensor system (not shown inFIGS. 9-10) to detect occlusions in the fluid path. For example, a light emitter and light sensor may each be arranged on a sensor circuit in the controller device200 (but aligned with the pump device100) so that the light sensor can detect the amount of light emitted by the light emitter and subsequently reflected from a component adjacent the fluid path. The reflected light level detected may be used to determine the pressure within the fluid path.
• Referring now toFIG. 11, some embodiments of a portableinfusion pump system500 employing one or more of the aforementioned features for detecting and responding to ambient air pressure and temperature conditions (e.g., similar to those depicted in any ofFIGS. 1,2, and9) can include a reusable pump apparatus (rather than a disposable pump device as previously described). In such circumstances, theinfusion pump system500 may comprise a reusable device that houses the control circuitry and the pump drive system within a single housing construct. In the particular embodiment depicted inFIG. 11, thepump system500 comprises a reusable pump device that houses both the control circuitry and the pump drive system (which may include a piston rod and one or more gears). Similar to previously described embodiments, thepump system500 can include a housing structure that defines a cavity in which a medicine cartridge can be received (not shown inFIG. 11; refer for example tocartridge120 inFIG. 2). For example, thepump system500 can be adapted to receive a medicine cartridge in the form of a carpule that is preloaded with insulin or another medicine. The pump drive system can act upon the fluid cartridge to controllably dispense medicine through aninfusion set146 and into the user's tissue or vasculature. In this embodiment, the user can wear theportable pump system500 on the user's skin under clothing or in the user's pocket while receiving the medicine dispensed through the infusion set146.
• Thepump system500 can also communicate with the aforementionedglucose monitoring device50 for the purpose of receiving data indicative of a user's blood glucose level. Similar to previously described embodiments, thepump system500 can utilize the data indicative of a user's blood glucose level to, for example, provide an alarm (e.g., an audible or textual safety alarm, an audible or textual alert notification, or another type of alarm) when the user's blood glucose level falls below a low glucose alarm limit or rises above a high glucose alarm limit. In some embodiments, as described further below in connection withFIGS. 12 and 13, theinfusion pump system500 can monitor actual ambient conditions such as air pressure and temperature. In some such embodiments, theinfusion pump system500 can include anair pressure sensor550 and/or atemperature sensor560 that can measure the ambient pressure and temperature conditions respectively. Thepressure sensor550 andtemperature sensor560 can be in electrical communication with the control circuitry. The control circuitry can initiate an alarm (e.g., an audible or textual safety alarm, an audible or textual alert notification, or another type of alarm) when the measured ambient conditions exceed predetermined alarm limits. In some embodiments, such textual alarms or alerts can be displayed to the user on adisplay522. In addition to alarming, in some embodiments the control circuitry viadisplay522 can provide instructions for the user to take actions to counteract the potential effects that the ambient conditions may potentially have on theinfusion pump system500. By implementing the instructions, the user's blood glucose level can be maintained within a desired range despite the exposure of theinfusion pump system10 to deviations in ambient conditions.
• In some embodiments, thedisplay522 can indicate an alarm indicative of a high or low ambient air pressure status, a high or low temperature status, an indication that the pressure or temperature levels are rising or falling (e.g., a noteworthy change in pressure or temperature), an indication of a high or low blood glucose level status, and the like. In the example depicted inFIG. 11, thedisplay522 indicates an alert in which the control circuitry has sensed a high temperature condition (above a predetermined high threshold level). In this embodiment, thedisplay522 also prompts the user to take particular countermeasures (as described further in reference toFIGS. 12 and 13), such as replacing the medicine in the cartridge, thereby helping the user to maintain blood glucose levels within the normal range.
• Still referring toFIG. 11, similar to previously described embodiments, thedisplay device522 can be used to communicate a number of settings or menu options for theinfusion pump system500. For example, thedisplay device522 can be used to communicate medicinal delivery information, such as the basal delivery rate, a bolus dosage, a historical record of medicine delivered, the amount of medicine remaining in the cartridge, or the like. In another example, thedisplay device522 can be used to communicate time and date information, which can be used by the user to determine dosage schedules, bolus delivery times, meal times, or the like. In such circumstances, the user may press one or more of thebuttons524a,524b,524c,524d, and524eto shuffle through a number of menus or program screens that show particular settings and data (e.g., review data that shows the medicine dispensing rate, the total amount of medicine dispensed in a given time period, the amount of medicine scheduled to be dispensed at a particular time or date, the approximate amount of medicine remaining in thecartridge120, or the like). Also, the user can adjust the settings or otherwise program thepump system500 by pressing one ormore buttons524a,524b,524c,524d, and524eof theuser interface520. Thus, the user can contemporaneously monitor the operation of thepump system500, including any messages pertaining to actual ambient conditions such as air pressure and temperature that have exceeded threshold limit values.
• Referring now toFIGS. 12 and 13, which illustrate example methods whereby an infusion pump system can detect ambient events and alert the user to take preventive or corrective actions directed to, for example, maintaining the efficacy of the treatment provided by the infusion pump system. The example methods ofFIGS. 12 and 13 will be described in the context of the example infusion pump system10 (e.g., ofFIGS. 1-10), however it should be understood from the description herein that the example methods can be implemented by other infusion pump systems, including but not limited to theinfusion pump system500 depicted inFIG. 11.
• Referring toFIG. 12, amethod600 is depicted whereby infusion pump system can detect and respond to an ambient pressure change event. An ambient pressure change event may occur in various real-world scenarios, e.g., when the user of the infusion pump system flies on an airplane, when a significant weather/barometric change occurs, or the like. For example, in the airplane scenario, the ambient air pressure will tend to decrease as the airplane gains altitude, and the ambient air pressure will tend to increase as the airplane descends in altitude.
• Themethod600 may includeoperation610, in which a baseline ambient air pressure is established. In some implementations, the baseline ambient air pressure can be the initial air pressure measured by thepressure sensor250 at the time that themedicine cartridge120 is installed into thepump device100, and thepump device100 is coupled to thecontroller device200. In some implementations, the baseline ambient air pressure can be a long-term rolling average of measured air pressure values. For example, thecontroller device200 may read a pressure value from thepressure sensor250 on a periodic basis (e.g., every 1 second, 5 seconds, 10 seconds, 20 seconds, 30 seconds, 1 minute, 15 minutes or another appropriate time frequency) and store the value in memory (e.g., the memory chip248). Then theprocessor243 may calculate an average of the stored pressure values over a relatively long-term period of time (e.g., the past 12 hours, 1 day, 2 days, 3 days, 4 days or more). In some implementations, the calculated average can be established as the baseline ambient pressure.
• Atoperation620, theinfusion pump system10 can detect an ambient pressure change event (as defined further below). As described above, thepressure sensor250 in conjunction with thecontroller device200 can measure the ambient air pressure around theinfusion pump system10. The measured air pressure values can be compared to threshold limit values that have been programmed and stored in thecontroller device200. If the measured air pressure values are outside of the threshold limit values an ambient pressure change event may have occurred. In some cases, signal conditioning (using hardware, software, or both) can be used to increase the confidence that an ambient pressure change event has occurred (e.g., to de-bounce the measured pressure values).
• The pressure threshold limit values can be programmed and stored in thecontroller device200. In some embodiments, the pressure threshold limit values are programmable by the user. In some embodiments, the threshold limit values are programmable only by an administrator of theinfusion pump system10, such as a physician, nurse, technician, or manufacturer. In some embodiments, the threshold limit values are programmable only using a computer system operated by an administrator of theinfusion pump system10, such as a physician, nurse, technician, or manufacturer.
• In some embodiments, one or more types of ambient air pressure threshold limits can be established. For example, instantaneous air pressure threshold limit values can be established. In other words, if a measured air pressure value is outside of the acceptable range as defined within the boundaries of the instantaneous air pressure threshold limit values (upper and lower values), an ambient pressure change event can be deemed to have occurred. In another example, a pressure-change-over-time threshold limit value can be established. In other words, if successively measured air pressure values indicate that the air pressure is changing (upward or downward) more rapidly than the pressure-change-over-time threshold limit value, then an ambient pressure change event can be deemed to have occurred. In some embodiments, other types of ambient air pressure threshold limits can also be established.
• Atoperation630, in response to the detection of an ambient pressure change event fromoperation620, theinfusion pump system10 determines whether the ambient pressure change event was an ambient pressure increase or decrease (e.g., relative to the baseline ambient pressure). If the ambient pressure change event was an ambient pressure increase (e.g., a pressure rise), the process proceeds tooperation645. If the ambient pressure change event was an ambient pressure decrease (e.g., a pressure drop), the process proceeds tooperation640.
• In the event of a detected pressure drop beyond the threshold limit, the method continues tooperation640, in which thecontroller device200 can output an alert indicative of an ambient pressure decrease. For example, in some embodiments thecontroller device200 can output an audible or textual safety alarm, an audible or textual alert notification, a vibrating alarm, a LED light alarm, another communicative alarm output, or combinations thereof.
• In some embodiments, the ambient condition alert feature ofoperation640 can be user-selectable. That is, in some embodiments the user can select options to activate or deactivate some types or all types of the ambient event alert messages. For example, in some cases the user may desire to activate the pressure change alert message feature, but to deactivate the temperature change alert message feature. Or, in some cases the user may desire to deactivate the pressure change alert message feature, but to activate the temperature change alert message feature. Or, in some cases the user may desire to activate both the pressure change alert message feature and the temperature change alert message feature. Or, in some cases the user may desire to deactivate both the pressure change alert message feature and the temperature change alert message feature.
• In some embodiments, the user may be provided with the option to “snooze” the ambient event alert for example, while he or she is taking actions to resolve the alarm circumstances. For example, the user interface can display a “snooze” or “postpone” option, which can be selected by the user to silence the alarm for a predetermined period of time (e.g., 5 minutes, 10 minutes, 15 minutes, 1 hour, or the like). In some embodiments, the settings that control the duration of the “snooze” timer can be modified to reduce the occurrences of repeated nuisance alarms or to increase the occurrence of alarms when the ambient conditions are far outside the alarm limits.
• Atoperation650, thecontroller device200 can output instructions to the user using the display222 (e.g., refer toFIG. 1). For example, in response to a detected ambient pressure drop the user may be provided with instructions to inspect theflexible tube72 of the infusion set70 to check if any bubbles are present. Bubbles may form in the fluid medicine in response to a significant pressure decrease because dissolved gasses in the medication liquid may tend to leave the liquid and form sizeable bubbles as the pressure decreases. Having bubbles in the liquid medicine can cause inaccurate dispensations of the medicine because as the bubbles form some medicine may be displaced into the user. If bubbles are present in the medicine, further pressure decreases can allow the bubbles to expand and thereby dispense additional medicine to the user unintentionally. In addition, bubbles can lead to later unintended under-delivery of medicine if the bubbles are delivered to the user in place of the medicine. If air bubbles are found in theflexible tube72, thecontroller device200 can output textual instructions that prompts the user to disconnect theflexible tube72 from the user (e.g., removing thetube72 from thecannula housing74, removing theentire tube72 andcannula housing74 from the skin surface, or the like) and flush a portion of the fluid medicine from theinfusion pump system10 that through the tube72 (e.g., similar to a priming operation) so as to remove the air bubbles. Alternatively, if air bubbles are found in theflexible tube72, thecontroller device200 can output textual instructions that prompts the user to disconnect the infusion set70 and to replace it with a new infusion set70 (e.g., connecting the new infusion set to thepump device100.
• In some embodiments, thecontroller device200 user may also provide instructions that prompts the user to take a contemporaneous blood glucose measurement. For example, taking a blood glucose measurement may be advisable in light of the potential that the ambient air pressure decrease may have caused bubble formation in the medicine that resulted in unintended dispensation of medicine. In some embodiments of theinfusion pump system10 in which thecontroller device200 is equipped with a blood strip reader, a test strip (e.g., blood test strip) containing a sample of the user's blood can be inserted into the strip reader portion of thecontroller device200 for testing the user's blood glucose level and automatically inputting the value into thecontroller200. Alternatively, the test strips (e.g., glucose test strips) containing a sample of the user's blood can be inserted into a separate glucose meter device (not shown), which can then analyze the characteristics of the user's blood and communicate the information (via a wired or wireless connection) to thecontroller device200. In still other embodiments, characteristics of the user's blood glucose information can be measured by a separate glucose meter device (not shown) and then manually entered directly intocontroller device200 via theuser interface220. Or, in some embodiments, the infusion pump system10 (refer, for example, toFIG. 1) can include a glucose monitoring device such asglucose monitoring device50. In some such embodiments, theglucose monitoring device50 can be in communication with thepump assembly60 via wireless communications or a wired connection. Using such example techniques, the user's blood glucose reading can be promptly measured in response to the ambient pressure drop alert.
• Operations640 and650 pertaining to an ambient pressure drop having been described above, now theoperations645 and655 pertaining to an ambient pressure increase will be described.
• In the event of a detected pressure increase beyond the threshold limit, the method continues tooperation645, in which an alert that is indicative of an ambient pressure rise is provided to the user. For example, in some embodiments thecontroller device200 can output an audible or textual safety alarm, an audible or textual alert notification, a vibrating alarm, a LED light alarm, another communicative alarm output, or combinations thereof. As described above in reference tooperation640, in some embodiments the alert can be user-selectable and the aforementioned snooze function may be provided.
• Atoperation655, thecontroller device200 can output textual instructions to the user using thedisplay222. For example, in response to an ambient air pressure rise, thecontroller device200 can output textual instructions that prompts the user to disconnect theflexible tube72 from the user (e.g., removing thetube72 from thecannula housing74, removing theentire tube72 andcannula housing74 from the skin surface, or the like) and to prime a few units of medicine through thetube72 so as to remove the air bubbles. Alternatively, if air bubbles are found in theflexible tube72, thecontroller device200 can output textual instructions that prompts the user to disconnect the entire infusion set70 and to replace it with a new infusion set70 (e.g., connecting the new infusion set to thepump device100. These instructs to the user may be warranted because a significant ambient pressure rise can cause the volume of the flow path occupied by the medicine to decrease, thereby generating some empty space within the flexible tube72 (which could lead to an under-delivery of medicine if not remedied).
• Optionally, themethod600 can also includeoperation660, in which theinfusion pump system10 alters the medicine dosage regimen based on the ambient pressure change. In some embodiments, in addition to alerting the user about the changes in ambient conditions, theinfusion pump system10 can alter the delivery of medicine in attempt to compensate of a projected change in delivery due to the change in ambient air pressure. This could be done to compensate for any known trapped air within the medicine path (such as a small volume of air trapped in the occlusion detector of the infusion pump system10) or to compensate for a projected amount of bubble formation and growth based on typical medications and environmental conditions. When a pressure change is detected, theinfusion pump system10 can, in some embodiments, alter previously programmed dispensations of medicine in proportion with the change in pressure. In some cases, for an increase in pressure, the delivery would be increased. In some cases, for a decrease in pressure, the deliveries would be decreased.
• Still referring toFIG. 12, themethod600 may includeoperation670, in which the infusion pump system detects that the ambient pressure has stabilized for a period of time. The detection is made bypressure sensor250 in conjunction withcontroller device200. In response to the detected stabilization of the ambient pressure, the process proceeds tooperation680.
• Atoperation680, theinfusion pump system10 provides the user with additional textual instructions via theuser interface220. For example, when the pressure has stabilized, thecontroller device200 can output textual instructions that prompts the user to check for bubbles and to remove them by flushing. In addition, thecontroller device200 can output textual instructions that prompts the user to monitor health symptoms, and to measure blood glucose. In general, the instructions may be directed to re-establishing normal operations of theinfusion pump system10.
• Atoperation690, theinfusion pump system10 resumes normal operations. After resuming normal operations, theprocess600 returns tooperation610 where a new baseline ambient pressure is determined based on measurements of the ambient air pressure bypressure sensor250 in conjunction withcontroller device200.
• Referring now toFIG. 13, amethod700 is depicted whereby infusion pump system can detect and respond to an ambient temperature event. A temperature event may occur in various real-world scenarios, e.g., when the user of theinfusion pump system10 goes outdoors into a very warm or a very cold climate, when a user enters a sauna or steam bath, or the like. As previously described, the example method depicted inFIG. 13 will be described in the context of the example infusion pump system10 (e.g., ofFIGS. 1-10), however it should be understood from the description herein that the example method can be implemented by other infusion pump systems, including but not limited to theinfusion pump system500 depicted inFIG. 11.
• Themethod700 may includeoperation710, in which a baseline ambient temperature is established. In some implementations, the baseline ambient temperature will be established by default at room temperature (about 19 degrees Celsius to about 25 degrees Celsius, and about 20 degrees Celsius in this particular example). In some implementations, the baseline ambient temperature will be a long-term rolling average of measured temperature values. For example, thecontroller device200 may determine a temperature value from thetemperature sensor260 on a periodic basis (e.g., every 1 second, 5 seconds, 10 seconds, 20 seconds, 30 seconds, 1 minute, 15 minutes or another appropriate time frequency) and store the value in memory (e.g., the memory chip248). Then theprocessor243 may calculate an average of the stored temperature values over a relatively long-term period of time (e.g., the past 12 hours, 1 day, 2 days, 3 days, 4 days or more). In some implementations, the calculated average can be established as the baseline temperature.
• Atoperation720, theinfusion pump system10 can detect a temperature event (e.g., an absolute temperature measurement outside of a predetermined range, a temperature change relative to the baseline temperature, or the like). As described above, in some embodiments thetemperature sensor260 in conjunction with thecontroller device200 can measure the ambient temperature around theinfusion pump system10. In some embodiments, theprocessor243 itself may have the capabilities to measure temperature. The measured temperature values can be compared to threshold limit values that have been programmed and stored in thecontroller device200. If the measured temperature values are outside of the threshold limit values, a temperature event may have occurred. In some cases, signal conditioning (using hardware, software, or both) can be used to increase the confidence that a temperature event has occurred (e.g., to de-bounce the measured pressure values). In some cases, an offset adjustment can be applied to the measured temperature value to compensate for the conditions near the temperature sensor260 (e.g., to better approximate the temperature of the medicine).
• The temperature threshold limit values can be programmed and stored in thecontroller device200. In some embodiments, the temperature threshold limit values are programmable by the user. In some embodiments, the threshold limit values are programmable only by an administrator of theinfusion pump system10, such as a physician, nurse, technician, or manufacturer. In some embodiments, the threshold limit values are programmable only using a computer system operated by an administrator of theinfusion pump system10, such as a physician, nurse, technician, or manufacturer.
• In some embodiments, one or more types of ambient temperature threshold limits can be established. For example, instantaneous temperature threshold limit values can be established. In other words, if a measured temperature value is outside of the acceptable range as defined within the boundaries of the instantaneous temperature threshold limit values (upper and lower values), a temperature event can be deemed to have occurred. In some embodiments, various levels of instantaneous temperature threshold limit values can be established. For example, absolute threshold levels (e.g., a lower value of 0 degrees Celsius and an upper value of 40 degrees Celsius) can be established. If the instantaneous measured temperature value falls outside of this absolute threshold range (0 to 40 degrees Celsius in this example), thecontroller device200 can out instructions via theuser interface220 that prompts the user to discard and replace the medicine supply (e.g., insulin cartridge in this embodiment). In another example, a temperature-change-over-time threshold limit value can be established. In other words, if successively measured temperature values indicate that the temperature is changing (upward or downward) more rapidly than the temperature-change-over-time threshold limit value (e.g., a significant temperature shock), then a temperature event can be deemed to have occurred. In some embodiments, other types of ambient temperature threshold limits can also be established.
• Atoperation730, in response to the detection of a temperature event fromoperation720, theinfusion pump system10 determines whether the temperature event was a temperature increase or decrease. If the temperature event was a temperature decrease, the process proceeds tooperation745. If the temperature event was a temperature increase, the process proceeds tooperation740.
• Atoperation740, thecontroller device200 can output an alert indicative of a temperature increase. For example, in some embodiments thecontroller device200 can output an audible or textual safety alarm, an audible or textual alert notification, a vibrating alarm, a LED light alarm, another communicative alarm output, or combinations thereof.
• As described above, in some embodiments the ambient condition alert feature ofoperation740 can be user-selectable. That is, in some embodiments the user can select to activate or deactivate some types or all types of the ambient event alert messages. In addition, in some embodiments the user may be provided with the aforementioned option to “snooze” the ambient event alert, for example while the user is taking actions to resolve the alarm circumstances.
• Atoperation750, thecontroller device200 can output instructions via the display222 (e.g., refer toFIG. 1, or display522 ofFIG. 11) that prompts the user to take one or more corrective actions. For example, in response to a detected temperature increase the user may be provided with instructions to inspect theflexible tube72 of the infusion set70 to see if any bubbles are present. Bubbles may form in the medicine in response to a temperature increase because dissolved gasses in the medication liquid may tend to leave the liquid and form bubbles as the temperature increases. Having bubbles in the liquid medicine can cause inaccurate dispensations of the medicine because as the bubbles form some medicine may be displaced into the user. If bubbles are present in the medicine, further temperature increases can allow the bubbles to expand and thereby dispense additional medicine to the user unintentionally. In addition, bubbles can lead to later unintended under-delivery of medicine if the bubbles are delivered to the user in place of the medicine. If air bubbles are found in theflexible tube72, in some embodiments the user can disconnect theflexible tube72 from thecannula housing74 and flush theinfusion pump system10 to remove the air bubbles.
• In some cases, if the temperature detected is above an absolute threshold value (e.g., a high threshold value selected from a range of about 37 degrees Celsius to about 42 degrees Celsius, and about 40 degrees Celsius in this example), thecontroller device200 can output instructions via theuser interface220 that prompts the user to discard the medicine supply. That is because, for example, insulin can deteriorate or otherwise lose some efficacy when exposed to temperatures substantially above human body temperature (about 37 degrees Celsius). In such a case, theinfusion pump system10 can provide instructions to discard the medicine. In some cases, the duration of time that the temperature was near or above the extreme threshold value can also be taken into account in regard to the provision of instructions. That is, the duration of time can be combined with the temperature (e.g., 43 degrees Celsius for a period of 10 minutes) in a formula that quantifies the potential for medicine degradation. In some cases, if the duration of time that the temperature was near or above the extreme threshold value was long enough, theinfusion pump system10 may self-disable the drive system so that no further dispensations of medicine are provided until themedicine cartridge120 has been replaced.
• In some embodiments, thecontroller device200 can output instructions via theuser interface220 that prompts the user to take a blood glucose measurement. For example, taking a blood glucose measurement may be advisable in light of the potential that the temperature increase may have caused bubble formation in the medicine that resulted in unintended dispensation of medicine.
• Operations740 and750 pertaining to a temperature increase having been described above, theoperations745 and755 pertaining to a temperature decrease will now be described. Atoperation745 an alert that is indicative of a temperature decrease event is provided to the user. For example, in some embodiments thecontroller device200 can output an audible or textual safety alarm, an audible or textual alert notification, a vibrating alarm, a LED light alarm, another communicative alarm output, or combinations thereof. As described above in reference tooperation740, in some embodiments the alert can be user-selectable and the aforementioned snooze function may be provided.
• Atoperation755, thecontroller device200 can output textual instructions to the user via thedisplay222. For example, in response to a temperature decrease, thecontroller device200 can output instructions via theuser interface220 that prompts the user to disconnect theflexible tube72 from the user (e.g., removing thetube72 from thecannula housing74, removing theentire tube72 andcannula housing74 from the skin surface, or the like) and to prime a few units of medicine through thetube72 so as to remove the air bubbles. Alternatively, if air bubbles are found in theflexible tube72, thecontroller device200 can output textual instructions that prompts the user to disconnect the entire infusion set70 and to replace it with a new infusion set70 (e.g., connecting the new infusion set to thepump device100. These instructs to the user may be warranted because, in response to a significant temperature drop, the volume of the medicine may have decreased leaving some empty space within the flexible tube72 (which could lead to an under-delivery of medicine if not remedied).
• In some cases, if the temperature detected is below an extreme threshold value (e.g., a high threshold value selected from a range of about −4 degrees Celsius to about 2 degrees Celsius, and about 0 degrees Celsius in this example), thecontroller device200 can output instructions via theuser interface220 that prompts the user to discard the medicine. That is because, for example, insulin can deteriorate or otherwise lose some efficacy when exposed to freezing temperatures (about 0 degrees Celsius or less). In such a case, thecontroller device200 can output instructions via theuser interface220 that prompts the user to discard the medicine supply. In some cases, the duration of time that the temperature was near or below the extreme threshold value can also be taken into account in regard to the provision of instructions. That is, the duration of time can be combined with the temperature (e.g., −5 degrees Celsius for a period of 8 minutes) in a formula that quantifies the potential for medicine degradation. In some cases, if the duration of time that the temperature was near or below the extreme threshold value was long enough, theinfusion pump system10 may self-disable the pump drive system to prevent further dispensations of medicine until themedicine cartridge120 has been replaced.
• Atoperation760, theinfusion pump system10 can optionally alter the dosage regimen based on the temperature change. In some embodiments, in addition to alerting the user about the changes in ambient conditions, theinfusion pump system10 could alter the delivery of medicine in attempt to compensate of a projected change in delivery due to the change in temperature. This could be done to compensate for any known trapped air within the medicine path (such as a small volume of air trapped in the occlusion detector of the infusion pump system10) or to compensate for a projected amount of bubble formation and growth based on typical medications and environmental conditions. When a temperature change is detected, theinfusion pump system10 can, in some embodiments, alter previously programmed dispensations of medicine in proportion with the change in temperature. In some cases, for a decrease in temperature, the delivery would be increased. In some cases, for an increase in temperature, the deliveries would be decreased.
• Atoperation770, the temperature is detected to be stable within ambient temperature threshold limits (e.g., greater than the low absolute limit of 0 degrees Celsius and lower than the high absolute limit of 40 degrees Celsius in this example). The detection is made bytemperature sensor260 in conjunction withcontroller device200. In response to the detected stabilization of the temperature, the process proceeds tooperation780.
• Atoperation780, theinfusion pump system10 provides the user with instructions viadisplay222. For example, when the temperature has stabilized, in some embodiments thecontroller device200 can output instructions via theuser interface220 that prompts the user to check for bubbles and remove them by flushing. In addition, thecontroller device200 can output instructions via theuser interface220 that prompts the user to monitor health symptoms, and to measure blood glucose. In general, the instructions can be directed to re-establishing normal operations of theinfusion pump system10.
• Atoperation790, theinfusion pump system10 resumes normal operations. After resuming normal operations, theprocess700 returns tooperation710 where a new baseline temperature is determined based on measurements of the ambient temperature bytemperature sensor260 in conjunction with controller device200 (or, alternatively, based upon the predefined setting such as the standard room temperature).
• A number of embodiments of the invention have been described. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the invention. Accordingly, other embodiments are within the scope of the following claims.

Claims (25)

What is claimed is:

1. A medical infusion pump system, comprising:

a portable pump housing that receives an insulin supply for dispensation to a user, the pump housing at least partially containing a pump drive system to dispense insulin from the insulin supply through a flow path to the user;

a controller that communicates with the pump drive system to dispense the insulin from the portable pump housing, the controller comprising a user interface display device; and

a pressure detection device that communicates with the controller,

wherein the controller, in response to a detected ambient air pressure level being less than a lower threshold value or greater than a higher threshold value, is configured to output an alarm and output a textual instruction via the user interface display indicative of maintaining the same insulin supply for subsequent dispensation.

2. The system ofclaim 1, wherein the user instructions comprise instructions to prime or flush insulin from the flow path.

3. The system ofclaim 1, wherein the user instructions comprise instructions to inspect for bubbles in the flow path.

4. The system ofclaim 1, wherein the controller is configured to resume normal operation of the infusion pump system in response to a user input, and wherein the user input is received by the controller while the pressure detection device is detecting the ambient air pressure level less than the lower threshold value or greater than the higher threshold value.

5. The system ofclaim 1, wherein the controller comprises a controller housing that removably attaches to the pump housing, the controller being electrically connected to the pump drive system when the controller housing is removably attached to the pump housing, wherein the controller is a reusable device while at least one of the pump housing and the pump drive system include a structure to prevent reuse of the pump housing and the pump drive system.

6. A medical infusion pump system, comprising:

a portable pump housing that receives insulin for dispensation to a user, the pump housing at least partially containing a pump drive system to dispense the insulin through a flow path to the user;

a controller that communicates with the pump drive system to dispense the insulin from the portable pump housing; and

a temperature detection device that communicates with the controller,

wherein the controller, in response to a detected temperature level being less than a lower threshold value or greater than a higher threshold value, is configured to output an alarm.

7. The system ofclaim 6, wherein the controller is further configured, in response to the detected temperature level being less than the lower threshold value or greater than the higher threshold value, to output user instructions for continuing operations of the infusion pump system.

8. The system ofclaim 6, wherein the controller is further configured, in response to a detected temperature level being less than a lower threshold value or greater than a higher threshold value, to output user instructions for continuing the operation of the infusion pump system using the same insulin supply and components of the infusion pump system.

9. The system ofclaim 8, wherein the user instructions comprise instructions to prime or flush insulin from the flow path.

10. The system ofclaim 8, wherein the user instructions comprise instructions to inspect for bubbles in the flow path.

11. The system ofclaim 6, wherein the controller is configured to resume normal operation of the infusion pump system in response to a user input, and wherein the user input is received by the controller while the temperature detection device is detecting the temperature level less than the lower threshold value or greater than the higher threshold value.

12. A medical infusion pump system, comprising:

a portable pump housing defining an opening that slidably receives a prefilled cartridge of insulin for dispensation to a user, the pump housing at least partially containing a pump drive system to dispense the insulin through a flow path to the user,

a controller that communicates with the pump drive system to dispense the insulin from the portable pump housing; and

a detection device that communicates with the controller, wherein the detection device is configured to detect an indicator on the prefilled cartridge of insulin that indicates whether the prefilled cartridge has sustained a particular temperature exposure level, and wherein the controller, in response to a detection of the indicator that the prefilled cartridge has sustained the particular temperature exposure level, is configured to output an alarm.

13. The system ofclaim 12, wherein the indicator comprises temperature sensitive ink.

14. The system ofclaim 12, wherein the detection device is an optical sensor.

15. The system ofclaim 12, wherein the controller in response to a detection of the indicator that the prefilled cartridge has sustained the particular temperature exposure level, is further configured to cease dispensations of insulin until the prefilled cartridge that sustained the particular temperature exposure level is replaced.

16. A method of operating an insulin infusion pump system, comprising:

receiving, at a controller of an insulin infusion pump system, ambient air pressure information indicative of an ambient air pressure external of the insulin infusion pump system;

determining if the ambient air pressure information is less than a low limit threshold value or greater than a high limit threshold value, wherein the low and high limit threshold values are stored in the memory of the controller; and

in response to determining the ambient air pressure information is less than the low limit threshold value or greater than the high limit threshold value, outputting (i) an alarm and (ii) user instructions for continuing operations of the insulin infusion pump system without replacing an insulin supply and components of the infusion pump system.

17. The method ofclaim 16, comprising clearing the alarm and resuming normal operation of the insulin infusion pump system in response to a user input, and wherein the user input is received by the controller while the ambient air pressure information is indicating that the ambient air pressure is less than the lower threshold value or greater than the higher threshold value.

18. The method ofclaim 16, wherein the user instructions comprise instructions to prime or flush insulin from the insulin infusion pump system.

19. The method ofclaim 16, wherein the user instructions comprise instructions to inspect for bubbles in the insulin infusion pump system.

20. A method of operating an insulin infusion pump system, comprising:

receiving, at a controller of an insulin infusion pump system, temperature information indicative of a temperature at the insulin infusion pump system;

determining, by the controller, if the temperature information is less than a low limit threshold value or greater than a high limit threshold value, wherein the low and high limit threshold values are stored in the memory of the controller; and

outputting, by the controller, an alarm in response to determining the temperature information is less than the low limit threshold value or greater than the high limit threshold value.

21. The method ofclaim 20, further comprising, in response to determining the temperature information is less than the low limit threshold value or greater than the high limit threshold value, outputting, by the controller, user instructions for continuing operations of the insulin infusion pump system without replacing insulin and components of the infusion pump system.

22. The method ofclaim 21, wherein the user instructions comprise instructions to prime or flush insulin from the insulin infusion pump system.

23. The method ofclaim 21, wherein the user instructions comprise instructions to inspect for bubbles in the insulin infusion pump system.

24. A medical infusion pump system, comprising:

a portable pump housing that receives a medicine supply for dispensation to a user, the pump housing at least partially containing a pump drive system to dispense medicine from the medicine supply through a flow path to the user;

a controller that communicates with the pump drive system to dispense the medicine from the portable pump housing; and

at least one of a pressure detection device and a temperature detection device configured to be coupled to the portable pump housing and to communicate with the controller.

25. The system ofclaim 24, wherein the controller, in response to a detected ambient pressure change event or a temperature event, is configured to output an alarm and output a textual instruction via a user interface display.

Images