Portable infusion pump and media player

Some embodiments of a portable infusion pump system can be configured to deliver medicine (e.g., insulin or the like) to a user and to deliver media content to a user. The media content can include, for example, MP3 music and other audio/video data stored in a memory device in the portable system. Thus, in particular embodiments, the portable infusion pump system can serve a dual purpose of providing medication and entertainment for the user from a compact and unobtrusive device.

TECHNICAL FIELD

This document relates to portable infusion pump systems to deliver fluids, such as insulin infusion pumps 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.

SUMMARY

Some embodiments of a portable infusion pump system can be configured to deliver medicine (e.g., insulin or the like) to a user while also delivering media content to the user. The media content can include, for example, MP3 music data or other audio/video data stored in a memory device in the portable system. Thus, in particular embodiments, the portable infusion pump system can serve a dual purpose of providing medication and entertainment for the user from a compact and unobtrusive device. Moreover, the infusion pump system may be used to deliver alarms that alert the user when the pump system requires user action or acknowledgement. In such circumstances, the pump system can be configured to interrupt the music content or other media content in order to deliver the alarm via the user's listening device (e.g., earbuds, other headphone device, or the like), thereby enhancing safety where the user might otherwise miss the alarm.

In particular embodiments, a medical infusion pump system may include a portable housing defining a space to receive a medicine. The system may also include a pump drive system to dispense medicine to a user from the housing when the medicine is received in the space. Further, the system may include a controller that electrically communicates with the pump drive system to transmit activation signals to the pump drive system. The system may also include an external audio device that communicates with at least a portion of the controller. The controller may access digital music content stored in a memory device to output selected music through the external audio device to the user. Also, the controller may interrupt the selected music output through the external audio device to the user in response to a medicine dispensation alarm condition.

Some embodiments described herein include a method of operating a medical infusion pump system. The method may include activating a pump drive system of a portable infusion pump system to dispense medicine to a user according to set parameters. Also, the method may include accessing digital music content stored in a memory device of the portable infusion pump system to output selected music through an external audio device to the user. The method may further include, in response to a detected alarm condition of the portable infusion pump system, interrupting the selected music output through the external audio device to the user so as to deliver an audible alert through the external audio device.

In certain embodiments, a medical infusion pump system may include a portable housing defining a space to receive a medicine. The system may also include a pump drive system to dispense medicine to a user from the housing when the medicine is received in the space. The system may further include a controller that electrically communicates with the pump drive system to transmit activation signals to the pump drive system. The system may further include a media content playback system that communicates with at least a portion of the controller to output selected media content to the user. The controller may access instructional media content stored in a memory device to output tutorial information through the media content playback system to the user. The tutorial information may communicate actions to be performed by the user of the medical infusion pump system.

In some embodiments, a medical infusion pump system may include a portable housing defining a space to receive a medicine, and a pump drive system to dispense medicine to a user from the housing when the medicine is received in the space. The system may also include a controller that electrically communicates activation signals to the pump drive system to control the dispensation of the medicine. The system may further include a media content playback system having an external audio device connectable to the controller so as to output selected media content to the user. The controller may access digital media content stored in a memory device to output selected media content through the external audio device to the user. The system may also include a user interface electrically coupled to the controller. The user interface may include a display device that contemporaneously displays medicinal delivery information and media content playback information.

Some embodiments described herein include a method of using a medical infusion pump system. The method may include actuating one or more buttons of a user interface of a portable infusion pump system so as to adjust a pump parameter. The portable infusion pump system may have a pump drive system to dispense medicine to a user according to the parameter. The method may also include actuating one or more buttons of the user interface to select media content for playback through an external audio device to the user. The selected media content may be stored with a plurality of digital media content files in a memory device of the portable infusion pump system. The method may further include contemporaneously receiving the medicine dispensed from the portable infusion pump system and receiving the playback of the selected media content output by the portable infusion pump system.

Some or all of the embodiments described herein may provide one or more of the following advantages: First, some embodiments of an infusion pump system can be capable of infusing medication (e.g., insulin or the like) to a user while also delivering audio or video media content to the user, thereby proving provide both medication infusion and entertainment output for the user. As such, there may be no need for the user to carry and operate a separate media playback device, thereby simplifying the process for selecting and receiving media playback and reducing the number of devices that must be carried by the user. Second, the infusion pump system can be configured to be compact and unobtrusive device, which provides a system that is readily portable and wearable. Third, the user can contemporaneously monitor infusion pump operation and control the media content playback from the same user interface on the portable system. Fourth, in some embodiments, the pump system can be configured to interrupt the music content or other media content in order to deliver an alarm via the user's external audio device (e.g., earbud device, other headphone device, or the like), thereby enhancing the user safety. Fifth, the media content played by the pump system may include an audio tutorial or other instructional content on how to operate particular features of the pump system, which can facilitate new user training in a manner that is helpful for children or other users in need of further training outside of a clinic environment.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

Some embodiments of an infusion pump system can serve a dual purpose of providing medication and entertainment for the user from a compact and unobtrusive device. For example, an infusion pump system can be portable and wearable such that the system is capable of infusing medication (e.g., insulin or the like) to a user while also delivering digital audio/video media content to the user. In such circumstances, the pump system can interrupt the music content or other media content in order to deliver the alarm via the user's earbuds or other headphone device, which enhances user safety where the user might otherwise miss the alarm. Also, the media content stored in, and output by, the pump system10may include an audio tutorial or other instructional content on how to operate particular features of the system, thereby facilitating new user training. As described in more detail below, particular embodiments of the infusion pump system may include a disposable pump device, and other embodiments may include a reusable pump device.

Referring now toFIGS. 1-3, some embodiments of an infusion pump system10can include a pump device100and a controller device200that can communicate with the pump device100. The pump device100can include a housing structure110that defines a cavity116in which a fluid cartridge120can be received. The pump device100also can include a cap device130to retain the fluid cartridge120in the cavity116of the housing structure110. The pump device100can include a drive system (described in more detail below) that advances a plunger125in the fluid cartridge120so as to dispense fluid therefrom. The controller device200can communicate with the pump device100to control the operation of the drive system. When the controller device200, the pump device100(including the cap device130), and the fluid cartridge120are assembled together, the user can (in some embodiments) conveniently wear the infusion pump system10on the user's skin under clothing or in the user's pocket while receiving the fluid dispensed from the pump device100.

The controller device200may be configured as a reusable component that provides electronics and a user interface to control the operation of the pump device100. In such circumstances, the pump device100can be a disposable component that is discarded after a single use. For example, as described in more detail below in connection withFIGS. 11-16, the pump device100can be a “one time use” component that is thrown away after the fluid cartridge120therein is exhausted. Thereafter, the user can removably attach a new pump device100′ (having a new medicine cartridge120′ as shown inFIG. 13) to the reusable controller device200for the dispensation of fluid from a new fluid cartridge120′. Accordingly, the user is permitted to reuse the controller device200(which may include valuable electronics or data) while disposing of the relatively low-cost pump device100after each use. Such a pump system10can provide enhanced user safety as a new pump device100(and drive system therein) is employed with each new fluid cartridge120.

Still referring toFIGS. 1-3, the infusion pump system10may also include an media content playback system230that can playback digital media content (e.g., music, voice instructions, audiobooks, audio that corresponds to a video being displayed, and other data) to the user while the pump system10is delivering the medicine to the user. The playback system230may comprise, for example, an external audio device231that plugs into a connection port234(refer toFIG. 17) so as to mate with an audio jack232housed by the controller device200. Furthermore, the playback system230can output to the user media content that is electronically stored in one or more memory devices246(refer toFIG. 17) arranged in the controller device200. Accordingly, the user can operate the infusion pump system10so as to receive controlled delivery of a medicine126while also viewing and/or listening to the playback of selected music, video, or other media content (e.g., playback of MP3, WMA, WMV, or DIVX files). In such embodiments, the pump system10may provide a compact, multi-purpose device that eliminates the need for the user to carry multiple devices (e.g., a medical pump device and a separate media player device). Moreover, the infusion pump system10can enhance user safety by interrupting the music content or other media content in order to deliver an alarm to the user that might otherwise go unnoticed if the user was listening to a separate media player device.

Briefly, in use, the pump device100can be configured to be removably attached to the controller device200in a manner that provides a secure fitting, an overall compact size, and a reliable electrical connection that is resistant to water migration. For example, as described in more detail below in connection withFIGS. 11-16, the controller device200can include a housing210having a number of features that mate with complementary features of the pump housing110. In such circumstances, the controller device200can be removably attached to the pump device100in a generally side-by-side configuration while not fully surrounding the pump housing110. Accordingly, in this embodiments, the pump device100and the controller device200can be separate components that fit together, but the overall size of the combined assembly can be reduced because there is no requirement for one component (e.g., the controller device) to completely surround or envelop the second component (e.g., the pump device). The compact size permits the infusion pump system10to be discrete and portable (as described below in connection withFIGS. 9-10). Moreover, at least one of the pump device100or the controller device200can include a release member that facilitates an easy-to-use detachment and replacement process.

Referring again toFIGS. 1-3, the pump system10can be a medical infusion pump system that is configured to controllably dispense a medicine from the cartridge120. As such, the fluid cartridge120can contain a medicine126(FIG. 1) to be infused into the tissue or vasculature of a targeted individual, such as a human or animal patient. For example, the pump device100can be adapted to receive a medicine cartridge120in 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 a cartridge120may be supplied, for example, by Eli Lilly and Co. of Indianapolis, Ind. Other examples of medicines contained in the fluid cartridge120include: pain relief drugs, hormone therapy, blood pressure treatments, anti-emetics, osteoporosis treatments, or other injectable medicines. The fluid cartridge120may have other configurations. For 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 the pump housing structure110that surround a plunger to define a reservoir in which the medicine is injected or otherwise received).

In some embodiments, the pump device100can include one or more structures that interfere with the removal of the medicine cartridge120after the medicine cartridge120is inserted into the cavity116. For example, as shown inFIG. 1, the pump housing structure110can include one or more retainer wings119that at least partially extend into the cavity116to engage a portion of the medicine cartridge120when the medicine cartridge120is installed therein. Such a configuration may facilitate the “one-time-use” feature of the pump device100. In some embodiments, the retainer wings119interfere with attempts to remove the medicine cartridge120from the pump device100, thus ensuring that the pump device100will be discarded along with the medicine cartridge120after the medicine cartridge120is emptied, expired, or otherwise exhausted. Accordingly, the pump device100can operate in a tamper-resistant and safe manner because the pump device100can be designed with predetermined life expectancy (e.g., the “one-time-use” feature in which the pump device is discarded after the medicine cartridge120is emptied, expired, or otherwise exhausted).

Still referring toFIGS. 1-3, the controller device200can be removably attached to the pump device100so that the two components are mechanically mounted to one another in a fixed relationship. Such a mechanical mounting can form an electrical connection between the removable controller device200and the pump device100. For example, the controller device200can be in electrical communication with a portion of a drive system (not shown inFIGS. 1-3, refer toFIG. 18) of the pump device100. As described in more detail below, the pump device100can include a drive system that causes controlled dispensation of the medicine or other fluid from the cartridge120. In some embodiments, the drive system incrementally advances a piston rod (not shown inFIGS. 1-3) longitudinally into the cartridge120so that the fluid is forced out of an output end122. A septum121(FIG. 1) at the output end122of the fluid cartridge120can be pierced to permit fluid outflow when the cap device130is connected to the pump housing structure110(described in more detail below). Thus, when the pump device100and the controller device200are attached and thereby electrically connected, the controller device200can communicate electronic control signals via a hardwire-connection (e.g., electrical contacts or the like) to the drive system or other components of the pump device100. In response to the electrical control signals from the controller device200, the drive system of the pump device100causes medicine to incrementally dispense from the medicine cartridge120.

As shown inFIG. 1, the pump device100can include an electrical connector118(e.g., having conductive pads, pins, and the like) that are exposed to the controller device200and that mate with a complementary electrical connector (refer to connector218inFIG. 8) on the adjacent face of the controller device200. The electrical connectors118and218provide the electrical communication between the control circuitry (refer, for example, toFIG. 17) housed in the controller device200and at least a portion of the drive system or other components of the pump device100. For example, in some embodiments, the electrical connectors118and218can permit the transmission of electrical control signals to the pump device100and the reception of feedback signals (e.g., sensor signals) from particular components within the pump device100. Furthermore, the infusion pump system10can include a gasket140that provides a seal around the electrical connector interface to thereby resist migration of external contaminants when the pump device100is attached to the controller device200. Thus, in some embodiments, the infusion pump system10can 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 system10).

Still referring toFIGS. 1-3, the controller device200can include a user interface220that permits a user to monitor the operation of the pump device100. In some embodiments, the user interface220includes a display device222and one or more user-selectable buttons (e.g., four buttons224a,224b,224c, and224din this embodiment). The display device222can include an active area in which numerals, text, symbols, images, or a combination thereof can be displayed (refer, for example, toFIG. 2). For example, the display device222can be used to communicate media content information226, which may related to the selected media content that is being delivered to the user through the playback system230. Also, the display device222can be used to communicate a number of settings or menu options for the infusion pump system10. For example, the display device222can be used to communicate medicinal delivery information227, such as the basal delivery rate (as shown inFIG. 1), a bolus dosage, a historical record of medicine delivered, the amount of medicine remaining in the cartridge120, or the like. In another example, the display device222can be used to communicate time and date information228, which can be used by the user to determine dosage schedules, bolus delivery times, meal times, or the like.

In this embodiment, the user may press one or more of the buttons224a,224b,224c, and224dto 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 the cartridge120, or the like). In some embodiments, the user can adjust the settings or otherwise program the controller device200by pressing one or more buttons224a,224b,224c, and224dof the user interface220. For example, in embodiments of the infusion pump system10configured to dispense insulin, the user may press one or more of the buttons224a,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. Accordingly, when the controller device200is connected to the pump device100, the user can be provided with the opportunity to readily monitor infusion pump operation by simply viewing the user interface220of the controller device200connected to the pump device100. Such monitoring capabilities may provide comfort to a user who may have urgent questions about the current operation of the pump device100. Also, in these embodiments, there may be no need for the user to carry and operate a separate module to monitor the operation of the infusion 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 the pump device100or to adjust settings of the pump system10(e.g., to request a bolus amount of medicine), the user can readily operate the user interface220of the controller device200, which is removably attached to the pump device100, without the requirement of locating and operating a separate monitoring module.

In another example, the user can press one or more of the buttons224a,224b,224c, and224dof the user interface220to play, pause, rewind, or fast-forward the selected media content226or to otherwise control the output of media content through the playback system230. Thus, when the controller device200is connected to the pump device100, the user can contemporaneously monitor infusion pump operation and control the media content playback from the same user interface220. Again, in these embodiments, there may be no need for the user to carry and operate a separate media playback device, thereby simplifying the process for selecting and receiving media playback and reducing the number of devices that must be carried by the user. Furthermore, in some embodiments, the pump system10can be configured to interrupt the music content or other media content in order to deliver an alarm via the user's external audio device231(e.g., earbud device, other headphone device, or the like), thereby enhancing the user safety. Finally, the media content played by the pump system10may include an audio tutorial or other instructional content on how to operate particular features of the system, which facilitates new user training (especially for children or other young users).

Referring to nowFIGS. 2-3, the infusion pump system10may be configured to be portable so that the user can readily carry or wear the pump system during operation. For example, a user can conveniently wear the infusion pump system10on the user's skin (e.g., skin adhesive) underneath the user's clothing or carry the pump device100in the user's pocket (or other portable location) while both receiving the medicine dispensed from the pump device100and receiving the playback of the selected media content. As described below in connection withFIG. 18, the drive system of the pump device100may be arranged in a compact manner so that the pump device100has a reduced length. For example, in the circumstances in which the medicine cartridge120has a length of about 6 cm to about 7 cm (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 7 cm to about 10 cm and about 7 cm to about 9 cm (about 8.3 cm or less in one embodiment). In addition, the pump housing structure110may have an overall height of about 2 cm to about 4 cm (about 3.1 cm or less in one embodiment) and an overall thickness of about 8 mm to about 20 mm (about 17.5 mm or less in one embodiment). In such circumstances, the controller device200can be figured to mate with the pump housing110so 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 system10(including the removable controller device200attached to the pump device100having the cap130) may have an overall length of about 7 cm to about 10 cm (about 9.3 cm or less in one embodiment), an overall height of about 2 cm to about 5 cm (about 4.2 cm or less in one embodiment), and an overall thickness of about 8 mm to about 20 mm (about 17.5 mm or less in one embodiment).

The pump system10is shown inFIGS. 2-3as being held in a user's hand5so as to illustrate an exemplary size of the system10in accordance with some embodiments. This embodiment of the infusion pump system10is 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) and receive the playback of the selected media content without the need for carrying and operating a separate module. In such embodiments, the pump device100can deliver the medicine126through an infusion set146, and the controller device can deliver the selected media content through the external audio device231.

The infusion set146includes tubing system that connects the infusion pump system10to the tissue or vasculature of the user (e.g., to deliver medicine into the tissue or vasculature under the user's skin). The infusion set146may include a flexible tube147that extends from the pump device100to a subcutaneous cannula149retained by a skin adhesive patch148that secures the subcutaneous cannula149to the infusion site. The skin adhesive patch148can retain the infusion cannula149in fluid communication with the tissue or vasculature of the patient so that the medicine dispensed through the tube147passes through the cannula149and into the user's body. The cap device130may provide fluid communication between the output end122(FIG. 1) of the medicine cartridge120and the tube147of the infusion set146. For example, the tube147may be directly connected to the output port139(FIG. 1) of the cap device130. In another example, the infusion set146may include a connector (e.g., a Leur connector or the like) attached to the tube147, and the connector can then mate with the cap device130to provide the fluid communication to the tube147. In these examples, the user can carry 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) while the tube147extends to the location in which the skin is penetrated for infusion. If the user desires to monitor the operation of the pump device100or to adjust the settings of the infusion pump system10, the user can readily access the user interface220of the controller device200without the need for carrying and operating a separate module

Still referring toFIGS. 2-3, the external audio device231can include one or more earbuds235that fit with the user's ear so as to direct the audio content into the ear for personal listening. The external audio device231can be used to deliver selected audio content236(refer toFIG. 2) for the user's listening enjoyment, but may also be used to interrupt the selected audio content to deliver an audible alert237(refer toFIG. 3) that notifies the user of a warning or condition related to the medicine delivery of the pump system10. For example, the user can operate the user interface220of the controller device200so that the selected music content236is output through the earbuds235to the user's ear. The media content information226can be shown in the display device222of the pump system10to indicate that the selected media content is now playing (refer, for example, to the “now playing” triangle symbol adjacent to the information226indicating the song title and artist as shown inFIG. 2). This may occur while the pump system is also operating to deliver controlled dosages of the medicine126to the user via the infusion set146.

In the event that an alarm condition (e.g., low power, low medicine volume, occlusion detection, drive system or electrical communication error, or the like) is detected by the pump system10, one or both of the external audio device231and the display device222can be used to communicate an alert237to the user. For example, as shown inFIG. 3, if the pump system10detects an occlusion in the medicine flow path (which can cause inaccurate dosage delivery), an audible alert237can be used to interrupt the playback of the music content236(FIG. 2) and notify the user of the detected occlusion. The audible alert237may be in the form of an alert beep, a voice notification, or a combination thereof. In particular embodiments, the audible alert237can include a voice notification that states: “Alert. An occlusion has been detected. Please check the infusion set for blockages.” In addition, the display device222of the controller200can be used to indicate that the music content236(FIG. 2) has been interrupted due to the detection of an alarm condition. For example, the display device222can indicate that the media content has automatically switched to a paused or stopped condition (refer, for example, toFIG. 3which shows the “paused” symbol in the area formerly occupied by the media content information226). Also, the display device222may provide a visual alert227that indicates the detected alarm condition.

In some circumstances, the playback of the media content may resume after the alert237(FIG. 3) has been communicated. For example, some alarm conditions may not require immediate intervention on the part of the user (e.g., a warning that the medicine cartridge120is 80% exhausted). Accordingly, the alert237may temporarily interrupt the music content236before the controller device200automatically resumes the playback of the music content. In other circumstances, the playback of the media content may remain in the paused state until the user acknowledges receipt of the alarm communication. For example, as shown inFIG. 3, the user can acknowledge the alarm communication by pressing the button224badjacent to the “clear” command. Other alarm conditions may require further intervention by the user. In those situations, the audible alert237may include voice instructions that indicate the actions to be performed by the user.

Referring now toFIGS. 4-5, the media content playback system230can deliver the selected media content to the user via a hardwired connection to the external audio device231(FIG. 4) or a wireless link to at least one body-worn earpiece235′ (FIG. 5). As previously described, the infusion pump system10can be worn by the user (e.g., in the user's pocket, connected to a belt clip, adhered to the user's skin, or the like) while delivering playback of the selected media content to the user's ear6. Thus, as shown inFIGS. 4-5, the pump system10can deliver the medicine126through the infusion set146adhered to the user's skin surface while contemporaneously outputting music content or other audio content to the user's ear6.

In the embodiment depicted inFIG. 4, the external audio device231comprises a cable connection between the earbuds235and the audio jack232(FIG. 17) housed in the controller device200. Accordingly, the user can arrange the pump system10so that the tubing147of the infusion set146extends from the pump device100to a targeted location on the user's skin and the cable of the external audio device231extends from the controller device200to the user's ear6.

In alternative embodiments, the playback system230can include a wireless link to the earpiece so as to eliminate the audio cable extending from the pump system10. For example, in the embodiment depicted inFIG. 5, the playback system230can include a wireless transmitter231′ that communicates media content data to a wireless earpiece device235′. The media content transmitter231′ can output short-range signals (e.g., Bluetooth signals, RF signals, or the like) indicative of the audio content that is to be output from the speaker in the earpiece235′. In this embodiment, the transmitter231′ is housed in the controller device200and is electrically connected to the control circuitry240therein (FIG. 17). The earpiece235′ can include an antenna and a wireless receiver arranged, for example, in a body-worn housing that is shaped to rest on the user's ear. As such, the wireless signals from the transmitter231′ are received by the earpiece235's to thereby output the audio content into the user's ear6. As previously described, the user can arrange the pump system10so that the tubing147of the infusion set146extends from the pump device100to a targeted location on the user's skin. However, in this embodiment, the user need not arrange the pump system10in a manner that accounts for an audio cable extending from pump system10because the earpiece235′ can receive the audio content information via the wireless link.

Referring now toFIG. 6, some embodiments of the playback system230can operate with a removable memory card250that stores one or more media content files thereon. For example, the user may store a number of MP3 music files on the memory card250using a personal computer (not shown inFIG. 6) and then insert the memory card250into a corresponding port251of the playback system230. As such, the playback system230can retrieve the media content data stored on the memory card in order to playback the media content to the user. Similar to previously described embodiments, the playback system230includes a connection port234that is configured to receive a cable of an external audio device231(FIGS. 1-3). Thus, the media content stored on the memory card250can be decoded or otherwise processed (e.g., by one or more components of the control circuitry240describe din connection withFIG. 17) so that the playback system230delivers the audio content to the earbuds or other speaker instrument of the external audio device231.

The controller device200can include a protective cover233that can fit over at least one or the connection port234and the memory card port251of the playback system230. The protective cover233is adjustable between an opened position (shown inFIG. 6) and a closed position in which the connection port234and the memory card port251are covered. The cover233may comprise a polymer material that serves to protect ports234and251from external contaminants when the cover233is in the closed position. For example, the cover233can comprise a flexible elastomers material that fits snugly in a depression over the ports234and251, thereby enabling the cover to provide a water resistant structure over the ports234and251.

Referring now toFIG. 7, some embodiments of the playback system230can operate with a removable data cable252that communicates one or more media content files from a separate computer system. For example, the user may store a number of MP3 music files on a personal computer (not shown inFIG. 7), and the user can connect the data cable252with a corresponding port253of the playback system230to transfer some or all of the MP3 files to an internal memory device (refer to memory device246inFIG. 17). In these circumstances, the user can periodically update or change the media content that is stored by the pump system and made available through the playback system230. The playback system230can retrieve the media content data stored on the internal memory device in order to playback the media content to the user. Similar to previously described embodiments, the playback system230includes a connection port234that is configured to receive a cable of an external audio device231(FIGS. 1-3). Thus, the media content stored on the internal memory device can be decoded or otherwise processed so that the playback system230delivers the audio content to the earbuds or other speaker instrument of the external audio device231. Also, in this embodiment, the controller device200can include the protective cover233to fit over at least one or the connection port234and the data cable port253of the playback system230. As previously described, the protective cover233is adjustable between an opened position and a closed position in which the connection port234and the memory card port251are covered. The cover233may comprise a polymer material that serves to protect ports234and251from external contaminants when the cover233is in the closed position.

Referring now toFIG. 8, some embodiments of the controller device200can be configured to receive media content files via a data cable connection with same electrical connector218that is capable of mating with the pump device100. For example, the removable data cable258can transmit one or more media content files to the controller device200from a separate computer system259. In such circumstances, the user may store a number of MP3 music files on a separate computer system259, and the user can connect the data cable258with the electrical connector218to transfer some or all of the MP3 files to an internal memory device of the controller device200(refer to memory device246inFIG. 17). Thus, the user can periodically update or change the media content that is stored by the pump system10and made available through the playback system230. The playback system230can retrieve the media content data stored on the internal memory device in order to playback the media content to the user via the external audio device231.

As shown inFIG. 8, the data cable258can mate with the electrical connector218when the controller device is separated from the pump device100. In the depicted embodiment, the controller device200is configured to be a reusable module that operates with a series of disposable pump devices100over a period of time. Accordingly after the data cable258transfers the selected media content to the internal memory of the controller device200, the data cable258can be disconnected to prepare the controller device200for attachment with the pump device100. The pump device100can be configured to be removably attached to the controller device200in a manner that provides a secure fitting, an overall compact size, and a reliable electrical connection that is resistant to water migration.

In this embodiment, the pump device100may be moved in a longitudinal direction toward the controller device200until one or more structures connect and secure the separate components in the side-by-side arrangement. For example, the controller device200includes a controller housing structure210having a number of features that are configured to mate with complementary features of the pump housing structure110so as to form a releasable mechanical connection. In the embodiment shown inFIG. 8, the pump housing structure110includes a barrel111that mates with a complementary barrel channel211of the controller housing210. Also, the pump housing110includes slider channel112that slidably engages a complementary rail212defined by the controller housing210. The slider channel112can guide the relative motion between the pump device100and the controller device200in the longitudinal direction during the attachment process. Similarly, the pump housing110may include a segmented rail114a-b(FIG. 1) that mates with a guide channel214a-bto direct the relative longitudinal motion between the pump device100and the controller device200. As described in more detail below, the segmented rails114a-bmay interact with the release member215so as to releasably secure the pump device100into assembly with the controller device200. In addition, the pump housing110may include an extension113(FIG. 1) that mates with a depression213(FIG. 5) in the controller housing210when the pump device100is fully attached to the controller device200.

Still referring toFIG. 8, when the pump device100is advanced in the longitudinal direction toward the controller device200as guided by the slider channel112and the segmented rails114a-b, the electrical connector118(FIG. 1) of the pump device100is directed toward engagement with the mating connector218(FIG. 8) of the controller device200. As the connectors118and218join together to form the electrical connection, the release member215is shifted to a position between the segmented rails114a-bso as to prevent withdrawal of the connection. Also, when the connectors118and218are mated, the extension113and barrel111are mated with the corresponding depression213and barrel channel211so as to resist relative rotational movement between the pump device100and the controller device200. In this embodiment, the physical attachment of the electrical connectors118and218may also serve to resist relative rotational movement between the pump device100and the controller device200. Furthermore, when the connectors118and218are mated, the slide channel112is mated with the corresponding rail112and barrel channel211so as to resist relative side-to-side movement between the pump device100and the controller device200.

Also, when the connectors118and218join together to form the electrical connection, the gasket140is compressed between the adjacent surfaces of the pump housing110and the controller housing210. The gasket140may comprise a polymer foam material that is adhered to a surface of either the pump housing110or the controller housing210(e.g., adhered to the pump housing110in this embodiment). The gasket140may be die cut to a selected shape so as to include an aperture for the electrical connection. Thus, in this embodiment, the gasket140surrounds the electrical connection when the pump device100is secured to the controller device200. The configuration provides protection from water migration to one or both of the electrical connectors118and218. Accordingly, in particular circumstances, the infusion pump system10can be assembled into a “water tight” configuration that protects sensitive internal components from water migration in the event that the user encounters water while wearing the pump system10.

Accordingly, the pump device100is configured to removably attach to the controller device200in a manner that provides a secure fitting, an overall compact size, and a reliable electrical connection. When the pump device100and the controller device200are arranged in this side-by-side configuration, the controller device200can be electrically connected with the pump device100while the controller device200remains outside of the pump housing110(and, likewise, the pump device100remains outside of the controller housing210). As such, the overall size of the assembled system10can be minimized, thereby providing an infusion pump system10having a discrete size and enhanced portability.

Additionally, in some embodiments, the attachment of the pump device100to the controller device200can be accomplished by a user with a convenient “one-movement” process. For example, as previously described, the user can readily slide the pump device100and the controller device200toward one another in a single movement (e.g., in the longitudinal direction) that causes both a physical connection and an electrical connection. As described in more detail below in connection withFIGS. 11-16, the release member215may be arranged so as to automatically adjust to a locked position when the pump device100is advanced into engagement with the controller device200. Thus, the infusion pump system10permits users to readily join the pump device100and the controller device200without compound or otherwise difficult hand movements—a feature that can be beneficial to child users or to elderly users.

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 device, mating tongues and grooves, mounting protrusions that friction fit into mating cavities, or the like.

Referring now toFIG. 9-10, a user can conveniently wear the infusion pump system10on the user's skin (e.g., skin adhesive) underneath the user's clothing or carry the pump device100in the user's pocket (or other portable location) while receiving both the medicine dispensed from the pump device100and the media content from the playback system230. As previously described, in some embodiments the user can receive the media content via an audio cable of an external audio device231(FIG. 9), and in alternative embodiments the user can receive the media content via a wireless link to an earpiece device235′ (FIG. 10).

Referring toFIG. 9, in some embodiments, the infusion pump system10is pocket-sized so that the pump device100and controller device200can be worn in the user's pocket6or in another portion of the user's clothing. For example, the pump device100and the controller device200can be attached together and form the system10that comfortably fits into a user's pocket6. The user can carry the portable infusion pump system10and use the tube147of the infusion set146to direct the dispensed medicine to the desired infusion site. In some circumstances, the user may desire to wear the pump system10in a more discrete manner. Accordingly, the user may pass the tube147from the pocket6, under the user's clothing, and to the infusion site where the adhesive patch148is positioned. As such, the pump system10can be used to delivery medicine to the tissues or vasculature of the user in a portable, concealable, and discrete manner. Moreover, the pump system10in this embodiment includes the external audio device231having earbuds235that connect to the controller device200via the audio cable. In this embodiment, the audio cable of the external audio device231can extend out of the user's pocket6along the outside of the user's clothing. As such, the user can readily insert and remove the earbuds depending upon the user's preference at that particular time.

Referring toFIG. 10, in other embodiments, the infusion pump system10may be configured to adhere to the user's skin7directly at the location in which the skin is penetrated for medicine infusion. For example, a rear surface102(FIG. 3) of the pump device100may include a skin adhesive patch so that the pump device100is physically adhered to the skin of the user at a particular location. In these embodiments, the cap device130may have a configuration in which medicine passes directly from the cap device130into an infusion cannula149that is penetrated into the user's skin. In one example, the fluid output port139through the cap device130can 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 the pump device100or to adjust the settings of the infusion pump system10, the user can readily access the user interface220of the controller device200without the need for carrying and operating a second, separate device. For example, the user may look toward the pump device100to view the user interface220of the controller device200that is removably attached thereto. In another example, the user can temporarily detach the controller device200(while the pump device100remains adhered to the skin7) so as to view and interact with the user interface220.

In the embodiments in which the pump system10is adhered to the user's skin under his or her clothing, the playback system230can include a wireless communication link to the earpiece device235′ (previously described in connection withFIG. 5). As such, the user can listen to music or other audio content stored in the pump system10without an audio cable that extends under his or her clothing to the pump system10. Also, in some embodiments, the user can operate a remote control device260to control the playback of media content through the playback system230. The remote control device260can be a portable module that fits in the user's hand or pocket. In this embodiment, the remote control device260includes a display screen and a plurality of buttons. The display screen can be used to indicate the media content information226(FIG. 1) related to the selected media content that is currently playing. The user can actuate the buttons of the remote control260to wirelessly control the playback of the media content stored in the pump system10(and output to the user via the playback system230). For example, the user can operate the remote control device260to select a different song, adjust the playback volume, pause or resume the playback, and other such operations. Again, the remote control device260can be implemented in the embodiments in which the pump system10is adhered to the user's skin so that the user can control the playback of music or other audio content stored in the pump system10under his or her clothing.

Referring now toFIGS. 11-16, the infusion pump system10can be operated such that the pump device100is a disposable, non-reusable component while the controller device200is a reusable component. In these circumstances, the pump device100may 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, the pump device100may 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 the cartridge120, the dispensation patterns that are selected for the individual user, and other factors. For example, in some embodiments, the medicine cartridge120containing insulin may have an expected usage life about 7 days after the cartridge is removed from a refrigerated state and the septum121is punctured. In some circumstances, the dispensation pattern selected by the user can cause the insulin to be emptied from the medicine cartridge120before the 7-day period. If the insulin is not emptied from the medicine cartridge120after the 7-day period, the remaining insulin may become expired sometime thereafter. In either case, the pump device100and the medicine cartridge120therein can be discarded after exhaustion of the medicine cartridge120(e.g., after being emptied, expired, or otherwise not available for use).

The controller device200, however, may be reused with subsequent new pump devices100′ and new 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, the controller device200may 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 device100after each use. Such a pump system10can provide enhanced user safety as a new pump device100′ (and drive system therein) is employed with each new fluid cartridge120.

Referring toFIGS. 11-12, the pump device100can be readily removed from the controller device200when the medicine cartridge120is exhausted. As previously described, the medicine cartridge120is inserted into the cavity116(FIG. 1) of the pump housing110where it is retained by the cap device130. In some embodiments, a portion of the pump housing110can comprise a transparent or translucent material so that at least a portion of the medicine cartridge120is viewable therethrough. For example, the user may want to visually inspect the medicine cartridge when the plunger125is approaching the output end122of the medicine cartridge, thereby providing a visual indication that the medicine cartridge may be emptied in the near future. In this embodiment, the barrel111of the pump housing110comprises a generally transparent polymer material so that the user can view the medicine cartridge120to determine if the plunger125is nearing the end of its travel length. Optionally, some embodiments of the pump device100may include a label117athat is adhered around the barrel111. The label117amay provide a convenient location for basic user instructions, product identification information, and other information related to the infusion pump system10. To provide enhanced viewability of the medicine cartridge120through the label117a, the label117amay include a window117bthrough which the user may visually inspect if the plunger125is nearing the end of its travel length.

As shown inFIG. 11, the pump device100has been used to a point at which the medicine cartridge120is exhausted. The plunger125has been advanced, toward the left inFIG. 11, over a period of time so that all or most of the medicine has been dispensed from the cartridge120. In some embodiments, the controller device200may 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 the medicine cartridge120through the barrel111of the pump housing110(and through the window117bof the label117ain this embodiment) to determine if the medicine cartridge120is almost empty. When the user determines that a new medicine cartridge120should be employed, the pump device100can be readily separated from the controller device200by actuating the release member215. In this embodiment, the release member215is a latch on the controller device200that is biased toward a locking position to engage the pump device100. The latch215may be arranged to engage one or more features on a lateral side of the pump housing110. As such, the user may actuate the release member215by moving the release member215in a lateral direction216(FIG. 11) away from the pump device100(e.g., by applying a force with the user's finger).

As shown inFIG. 12, when the release member215is actuated and moved to a position away from the pump device100, the segmented guide rail114a-bis free to slide longitudinally in the guide channel214a-bwithout interference from the release member215. Accordingly, the user can move the pump device100in a longitudinal direction217away from the controller device200. For example, the segmented guide rail114a-bmay slide along the guide channel214a-b, the extension113(FIG. 1) may be withdrawn from the mating depression213(FIG. 12), and the electrical connector118can be separated from the mating connector218. In these circumstances, the pump device100is physically and electrically disconnected from the controller device200while the pump device retains the exhausted medicine cartridge120.

In some embodiments, the gasket140compressed between the pump device100and the controller device200may comprise a resilient material. In such circumstances, the gasket140can provide a spring-action that urges the pump device100to shift a small amount away from the controller device200when the release member215is moved to the unlocked position (e.g., move in the lateral direction216in the embodiment shown inFIG. 11). Accordingly, in some embodiments, the pump device100can automatically and sharply move a small distance (e.g., about 0.5 mm to about 5 mm) away from the controller200when the release member215is moved to the unlocked position. Such an automatic separation provides a convenient start for the user to detach the pump device100away from the controller device200. Furthermore, this automatic separation caused by the spring-action of the gasket140can provide a swift disconnect between the electrical connectors118and218when the pump device100is being replaced.

Referring toFIGS. 13-14, the same controller device200can be reused with a new pump device100′ having a new medicine cartridge120′ retained therein, and the previously used pump device100can be discarded with the exhausted medicine cartridge120. The new pump device100′ (FIG. 13) can have a similar appearance, form factor, and operation as the previously used pump device100(FIGS. 11-12and14), and thus the new pump device100′ can be readily attached to the controller device200for controlled dispensation of medicine from the new medicine cartridge120′. In some embodiments, the user may prepare the new pump device100for use with the controller device200. For example, the user may insert the new medicine cartridge120′ in the cavity116of the new pump device100′ and then join the cap device130to the pump housing to retain the new medicine cartridge120′ therein (refer, for example, toFIG. 1). Although the tubing147of the infusion set146is not shown inFIG. 13, it should be understood that the tubing147may be attached to the cap device130prior to the cap device130being joined with the housing110. For example, a new infusion set146can be connected to the cap device130so that the tubing147can be primed (e.g., a selected function of the pump device100controlled by the controller200) before attaching the infusion set patch to the user's skin. As shown inFIG. 13, the new medicine cartridge120′ may be filled with medicine such that the plunger125is not viewable through the barrel111.

As shown inFIG. 14, the previously used pump device100that was separated from the controller device (as described in connection withFIGS. 11-12) may be discarded after a single use. In these circumstances, the pump device100may be configured as a disposable “one-time-use” device that is discarded by the user after the medicine cartridge120is emptied, is expired, has ended its useful life, or is otherwise exhausted. For example, the pump device100may be discarded into a bin20, 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 device100after each use while reusing the controller device200(which may include complex or valuable electronics) with subsequent new pumps100′. Also, in some circumstances, the infusion set146(not shown inFIG. 14, refer toFIG. 8) that was used with the pump device100may be removed from the user and discarded into the bin20along with the pump device100. Alternatively, the infusion set146can be disconnected from the previous pump device100and attached to the new pump device100′. In these circumstances, the user may detach the infusion set cannula and patch from the skin so as to “re-prime” the tubing with medicine from the new pump device100′ to remove air pockets from the tubing. Thereafter, the infusion set cannula and patch can be again secured to the user's skin.

Referring toFIGS. 15-16, the new pump device100′ can be removably attached to the controller device200to assemble into the infusion pump system10for delivery of medicine to the user. Before the pump device100is electrically connected with the controller device200, the user may prepare the new pump device100′ for use by pulling the removable tab141away from the pump housing110. In this embodiment, the new pump device100′ includes the removable tab141to seal the battery in the unused pump device100′ and thereby maintain the battery in a storage mode (refer, for example, toFIG. 14in which the removable tab141is arranged to cover an internal face of a vent145). The vent145can be implemented in some embodiments of the infusion pump system10having a power source arranged that draws upon surrounding air for optimum operation. Because the controller device200and the pump device100may be sealed to resist water migration during normal usage, the water-resistant vent instrument145may be used to provide the air to the power source without permitting migration of water therethrough. For example, in this embodiment, the pump device100may house a power source345in the form of a zinc-air cell battery (refer toFIG. 18), which draws upon the surrounding air during operation. When the pump device100is in use, the pump housing110is preferably sealed to protect the internal drive system and medicine cartridge from water migration. As such, the pump housing110may include the water-resistant vent145disposed proximate to the zinc-air cell battery345so that some air may pass through the vent145and toward the battery. The water-resistant vent instrument145may include one or more layers of a material that is permeable to air and resistant to passage of liquids such as water. For example, the water-resistant vent instrument145may include one or more layers of a GORE-TEX material to resist the migration of water into the pump device while permitting the passage of air toward the battery.

As described in more detail below, when the new pump device100′ is prepared for usage, the removable tab141can be pulled away from the pump housing110(and away from the battery therein), which switches the battery into an activation mode. Thus, the shelf-life of the pump device100′ (prior to usage with the controller device200) may be extended by sealing the battery in a storage mode because little, if any, energy is dissipated from the battery when in the storage mode.

The new pump device100′ can be connected to the controller device200by advancing the new pump device100′ in a longitudinal direction219(FIG. 15) toward the controller device200. When the pump device100′ is advanced in the longitudinal direction219toward the controller device200, the movement is guided by the slider channel112(FIG. 8) and the segmented rails114a-b. In particular, the slider channel112of the pump housing engages the rail212of the controller housing210. Also, the front portion of the segmented rail114aslides into the rear portion of the guide channel214b. In this embodiment, the front portion of the segmented rail114aincludes a ramp surface114c(refer also toFIG. 1) that engages a complementary ramp surface215c(FIG. 8) of the release member215to thereby force the release member215away from the guide channel214a-bduring advancement of the pump device100′. The release member215is temporarily forced away from the guide channel214a-bso that the front portion of the segmented rail114apasses over the release member215, which enables the electrical connector118of the pump device100′ to engage with the mating connector218of the controller device200. As the connectors118and218join together to form the electrical connection, the release member215biased to return to its latched position and is shifted to a position in the guide channel214a-bbetween the segmented rails114a-bso as to prevent withdrawal of the pump device100′.

As previously described, the guided motion in the longitudinal direction219provides the user with a convenient “one-movement” process to attach the pump device100′ and the controller device200. For example, the user can readily slide the pump device100′ and the controller device200toward one another in a single movement (e.g., in the longitudinal direction) that causes both a physical connection and an electrical connection. Thus, the infusion pump system10permits users to readily join the pump device100′ and the controller device200without compound or otherwise difficult hand movements—a feature that can be beneficial to child users or to elderly users.

As shown inFIG. 16, when the new pump device100′ is fully advanced and attached to the controller device200, the gasket140is compressed between the opposing surfaces of the pump housing110and the controller housing210. Such a configuration provides a water-resistance seal around the electrical connection that protects the sensitive internal components of the pump device100′ and the controller device200from damage or malfunction.

As previously described in connection withFIGS. 2-3, the tubing147of the infusion set146can be attached to the cap device130to provide a fluid path from the new pump device100′ to the user. Likewise, the external audio device231of the playback system230can be connected to the controller device200so as to deliver selected media content to the user.

In some embodiments, the playback system230can be configured to provide tutorial content or voice instructions to the user during the process previously described in connection withFIGS. 11-16. For example, when the user is going to detach the controller device200and discard an exhausted pump device100(as previously described), the user can activate the playback system230to output voice instructions through the external audio device231that guides the user on the detachment operations. Furthermore, the voice instructions can guide the user through the operations of preparing a new pump device100′ and removably attaching the new pump device100′ to the controller device200in a manner that provides a secure fitting, an overall compact size, and a reliable electrical connection.

Referring now toFIG. 17, the controller device200(shown in an exploded view) houses a number of components that can be reused with a series of successive pump devices100. In particular, the controller device200includes control circuitry240arranged in the controller housing210that is configured to communicate control signals to the drive system of the pump device100. In this embodiment, the control circuitry240includes a main processor board242that is in communication with a power supply board244. The control circuitry240includes at least one processor243that coordinates the electrical communication to and from the controller device200(e.g., communication between the controller device200and the pump device100). The processor243can be arranged on the main processor board242along with a number of other electrical components such as at least one memory device246. It should be understood that, although the main processor board242is 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 the processor243to operate. The control circuitry240can be programmable in that the user may provide one or more instructions to adjust a number of settings for the operation of the infusion pump system10. Such settings may be stored in the memory device246arranged in the control circuitry240. Furthermore, in some embodiments the memory device246can store executable software instructions for the processor243. Alternatively, the control circuitry240may include other dedicated memory devices (e.g., separate from the memory device246) that store executable software instructions for the processor243. The control circuitry240may include other components, such as sensors, that are electrically connected to the main processor board242. For example, at least a portion of an occlusion sensor system (not shown inFIG. 17) can be electrically connected to the main processor board242via a flexible circuit substrate or one or more wires.

As previously described, the controller device200can be electrically connected with the pump device100via mating connectors118and218(FIGS. 1 and 8) so that the control circuitry240can communicate control signals to the pump device100and receive feedback signals from components housed in the pump device100. In this embodiment, the electrical connector118(FIG. 1) on the pump device100is a z-axis connector, and the connector218(FIG. 8) on the controller device200is adapted to mate therewith. The electrical connector218on the controller device200is in communication with the control circuitry240. As such, the processor243can operate according to software instructions stored in the memory device246so as to send control signals to the pump device100via the connector218.

The memory device246connected to the control circuitry240can be configured to store media content for use by the playback system230. For example, the memory device246can electronically store a number of MP3 music files or other audio content data for subsequent playback to the user via the earbuds of external audio device231. In some embodiments, the memory device246can include a first memory portion247athat stores media content files, such as music, audiobooks, interactive games, images and other video data, or the like. The first memory portion246acan be made available for updating or otherwise changing the media content files in accordance with the user's selections. In addition, the first memory portion246acan include other information related to the media content stored therein, including title and artist/author information, playback history information, licensing and authorization information, playlist information, or the like.

The memory device246may also include a second memory portion247bthat is dedicated to storing infusion pump data, such as pump settings and menu options, basal and bolus dispensation data, executable software instructions (for the processor243) that control the operation of the pump device100, and the like. The second memory portion247bcan be selected to provide ample storage space for the infusion pump data so that the pump device100can safely dispense the medicine in accordance with the signals from the properly operating control device200. In particular embodiments, the second memory portion247bmay be partitioned or segregated the first memory portion247aor otherwise protected from overwriting during the process of updating or changing the media content files stored in the first memory portion247a. In alternative embodiments, the memory device246may comprise a plurality of separate memory cards or memory chips accessible to the processor243, some of which are dedicated to the media content data and others that are dedicated to the infusion pump data.

Still referring toFIG. 17, the playback system230can include an audio jack232or other media device output (e.g., wireless transmitter231′ for outputting media content data to the earpiece235′ shown inFIG. 5) that is electrically connected to the control circuitry240. As such, the processor243can execute a media player software program stored in the memory device246so as to decode or otherwise retrieve one or more media content files and output signals via the audio jack232. The signals output from the audio jack232can include audio signals that cause the external audio device231to generate audible sounds indicative of the selected media content (e.g., song, audiobook, voice instructions, or the like). In this embodiment, the audio jack232comprises a connector that mates with a plug end of the external audio device231. The audio jack232can be arranged in the controller housing210so that it is generally aligned with the port234that receives the plug end of the external audio device231.

Still referring toFIG. 17, the user interface220of the controller device200can include input components, output components, or both that are electrically connected to the control circuitry240. For example, in this embodiment, the user interface220includes the display device222having an active area that outputs information to a user and four buttons224a-dthat receive input from the user. Here, the display222may be used to communicate a number of settings or menu options for the infusion pump system10. In this embodiment, the control circuitry240may receive the input commands from the user's button selections and thereby cause the display device222to output 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 the cartridge120, or the like). As previously described, the controller circuit240can be programmable in that the input commands from the button selections can cause the controller circuit240to change any one of a number of settings for the infusion pump system10. In addition, the display222may be used to show the media content information226(FIG. 1) related to selected media content loaded by the playback system230. Again, the control circuitry240may receive the input commands from the user's button selections and thereby cause the display device222to output a number of playlists, menus, or program screens that show media content settings and data (e.g., titles, artists, customized playlists, usage or playback statistics, or the like). As previously described, the controller circuit240can be programmable in that the input commands from the button selections can cause the controller circuit240to change any one of a number of media content settings.

As previously described in connection withFIGS. 7 and 8, some embodiments of the pump system10include a cable connector (e.g., a data cable port or a data cable that mates with connector218) for communicating with a separate computer system. As such, the data cable may electrically connect to the control circuitry240to upload data or program settings to the controller circuit or to download data from the control circuitry240. For example, historical data of medicine delivery 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.

Still referring toFIG. 17, the control circuitry240of the controller device200may include a second power source245that can receive electrical energy from a first power source345(FIG. 18) housed in the pump device100. In this embodiment, the second power source245is coupled to the power supply board244of the control circuitry240. The hard-wired transmission of the electrical energy can occur through the previously described connectors118and218(FIGS. 1 and 8). In such circumstances, the first power source345(FIG. 18) may include a high density battery that is capable of providing a relatively large amount of electrical energy for its package size, while the second power source245(FIG. 17) may include a high current-output battery that is capable discharging a brief current burst to power the drive system300of the pump device100. Accordingly, the first battery345disposed in the pump device100can be used to deliver electrical energy over time (e.g., “trickle charge”) to the second battery245when the controller device200is removably attached to the pump device100. For example, as previously described, the first battery345may comprise a zinc-air cell battery. The zinc-air cell battery345may have a large volumetric energy density compared to some other battery types. For example, the zinc-air cell battery345may have a volumetric energy density of greater than about 900 Watt-hours/Liter (Wh/L), about 1000 Wh/L to about 1700 Wh/L, and about 1200 Wh/L to about 1600 Wh/L. 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 the removable tab141or the like) during storage and before activation. One exemplary zinc-air cell battery provides a potential voltage of about 1.1V to about 1.6V (about 1.2V to about 1.4 V, and about 1.3 V in one embodiment), a current output of about 8 mA to about 12 mA (about 10 mA in one embodiment), and a storage capacity of greater than about 600 mA·h (about 650 mA·h in one embodiment).

As shown inFIG. 17, the second battery245may include a high current-output device that is housed inside the controller housing210. The second battery245can be charged over a period of time by the first battery345and then intermittently deliver high-current bursts to the drive system300over a brief moment of time. In addition, the second battery245can be used to power the playback system230so that the selected media content (stored in the memory device246) is delivered to the user (e.g., via the external audio device231in this embodiment). For example, the second battery245may comprise a lithium-polymer battery. The lithium polymer battery disposed in the controller device200may have an initial current output that is greater than the zinc-air cell battery disposed in the pump device100, but zinc-air cell battery may have an energy density that is greater than the lithium polymer battery (e.g., the lithium polymer battery disposed in the controller device200may have a volumetric energy density of less than about 600 Wh/L). In addition, the lithium-polymer battery245is readily rechargeable, which permits the zinc-air battery345disposed in the pump device100to provide electrical energy to the lithium-polymer battery245for purposes of recharging. One exemplary lithium-polymer battery provides a initial current output of about greater than 80 mA (about 90 mA to about 110 mA, and about 100 mA in one embodiment) and a maximum potential voltage of about 4.0V to and 4.4V (about 4.2 V in one embodiment). In other embodiments, it should be understood that the second power source245may comprise a capacitor device capable of being recharged over time and intermittently discharging a current burst to activate the drive system300.

Accordingly, the infusion pump system10having two power sources345and245—one arranged in the pump device100and another arranged in the reusable controller device200—permits a user to continually operate the controller device200without having to recharge a battery via a wall-plug or other cable. Because the controller device200can be reusable with a number of pump devices100(e.g., attach the new pump device100′ after the previous pump device100is expended and disposed), the second power source245in the controller device can be recharged over a period of time each time a new pump device100is connected thereto. Such a configuration can be advantageous in those embodiments in which the pump device100is configured to be a disposable, one-time-use device that attaches to a reusable controller device200. For example, in those embodiments, the “disposable” pump devices100recharge the second power source245in the “reusable” controller device200, thereby reducing (or possibly eliminating) the need for separate recharging of the controller device200via a power cord plugged into a wall outlet.

In particular embodiments, the activation of the media content playback system230may be limited if the controller device200detects that the remaining capacity of the power source (e.g., battery245in this embodiment) reaches below a threshold level. In such circumstances, the remaining battery power can be automatically reserved for use in operating the drive system300to deliver medicine to the user. Alternatively, the playback system230may be limited by the controller device200based on a power use profile. The power use profile can provide an estimate of remaining battery life based on the user's activity with the infusion pump system10(e.g., activations of the drive system to provide basal and bolus dispensations, historical interaction with the user interface220, history of activating the playback system230, and the like). Using this power use profile, the controller device200can estimate how long the remaining battery power will last in order to dispense the medicine remaining in the cartridge120. If the power use profile indicates that the remaining battery power may be insufficient, particular features such as the playback system230may be limited or shut off in order to conserve the remaining battery power for activating drive system and indicating alarms. In another example, the controller device200may limit the number of uses of the playback system230to a predetermined amount of usage (e.g., total output time or the like) per day or per attachment of a new pump device100. Again, providing a limit on the usage of playback system230can conserve the battery power for other operations such as alarm indications and the drive system.

Referring now toFIG. 18, the pump device100may include a drive system300that is controlled by the removable controller device200(FIGS. 1-3and8). Accordingly, the drive system300can accurately and incrementally dispense fluid from the pump device100in a controlled manner. The drive system300may include a flexible piston rod370that is incrementally advanced toward the medicine cartridge120so as to dispense the medicine from the pump device100. At least a portion of the drive system300is mounted, in this embodiment, to the pump housing110. In this embodiment, the pump housing110includes a chassis107that is at least partially covered by a shell portion (removed fromFIG. 18for purposes of illustrating the drive system300). The shell portion can be used to cover at least a portion of the drive system300. The shell portion can slide over and join with the chassis107(and other body portions) to form the assembled pump housing110.

Some embodiments of the drive system300may include a battery powered actuator (e.g., reversible motor320or the like) that resets a ratchet mechanism330, a spring device350(FIG. 22) that provides the driving force to the ratchet mechanism330, and a drive wheel360that is rotated by the ratchet mechanism330to advance the flexible piston rod370toward the medicine cartridge120. Also, the pump device100can include one or more motion detectors coupled with the drive system300to provide feedback regarding the operation of the drive system300. For example, the pump device100may include a first motion detector302configured as a limit switch that detects when a portion of the ratchet mechanism330has reached the limit of its travel and must thereafter stop movement or reverse direction. In another example, the pump device100may include a second motion detector307in the form of a mechanical error switch that indicates whether components of the drive system300completed the desired motion for each drive cycle.

Still referring toFIG. 18, the pump device100includes a connector circuit310to facilitate the transfer of signals to and from the electrical connector118(FIG. 1). As previously described, the electrical connector118of the pump device100mates with the connector218(FIG. 8) of the controller device200so that electrical communication can occur between the pump device100and the controller device200. The connector circuit310may comprise a generally non-complex circuit310that does not include a processor or other relatively high-cost components. In this embodiment, the connector circuit310operates as a passageway for the control signals (from the control circuitry240(FIG. 17) of the controller device200) to transmit to the drive system300(e.g., to the actuator320). For example, the reversible motor320may be connected to the connector circuit310via one or more wires304. The connector circuit310also operates as a passageway for the electrical power from the first battery345(FIG. 18) to pass to the controller device200for recharging of the second battery245(FIG. 17). For example, the first battery345may be connected to the connector circuit310via one or more power contacts305. Furthermore, the connector circuit310operates as a passageway for feedback signals (e.g., from the motion detectors302and307) to transmit to the control circuitry240(FIG. 17) of the controller device200. For example, the limit switch302may be connected to the connector circuit310via one or more wires306(the one or more wires connecting the mechanical error switch307to the connector circuit310are not shown inFIG. 18).

In some embodiments, the connector circuit310in the pump device100includes a memory device318that can store data regarding the pump device100and its operational history. For example, the memory device318of the connector circuit310may include a flash memory chip that is configured to store data such as: a unique serial number designated for the pump device100, a manufacturer identifier code, and a drive cycle counter. The unique serial number designated for the pump device100and the manufacturer identifier code may be useful pieces of quality control information that remains with the pump device100throughout its shelf-life and operational life. If, for example, a manufacturing error is identified for a particular pump device100, the unique serial number and the manufacturer identifier code (e.g., a lot code) can be used to promptly identify the manufacturing location and its manufacturing lot.

The drive cycle counter stored in the memory device318can be useful for maintaining an accurate estimate of the volume of medicine that remains in the medicine cartridge120. For example, the number of drive cycles that are required to incrementally advance the plunger125and thereby dispense a full medicine cartridge120may be a predetermined value (e.g., in some embodiments, 6,300 drive cycles result in full dispensation of a new medicine cartridge). Accordingly, the drive cycle counter stored in the memory device318can keep track of the number of drive cycles that have occurred through the operational life of the pump device100. Each time the motor320completes a new drive cycle and incrementally advances the piston rod370to dispense some medicine, the controller device200can store an updated value for the drive cycle counter stored in the memory device318. When the updated value stored in drive cycle counter stored in the memory device318approaches the predetermined value, the controller device200can alert the user that the medicine cartridge is approaching exhaustion. Furthermore, because the memory device318is arranged in the pump device100, the drive cycle counter stored in the memory device318remains local to the pump device100. If the pump device100is temporarily disconnected from the controller device200and then reconnected (or reconnected to a different controller device200), the controller device200can retrieve the value for the drive cycle counter stored in the memory device318and promptly ascertain how much medicine remains in the medicine cartridge120.

Still referring toFIG. 18, in some embodiments, the flexible piston rod370comprises a plurality of segments372serially connected by hinge portions373so that the flexible piston rod370is adjustable from a curved shape to a noncurved shape. The plurality of segments372and the interconnecting hinge portions373can be integrally formed in one piece from one or more moldable materials, including polymer materials such as Nylon or POM. In this embodiment, each of the plurality of rod segments372includes an exterior thread pattern374along at least one cylindrical surface portion. The piston rod370also includes a plunger engagement device375can be arranged at a forward end of the piston rod370. As such, the plunger engagement device375faces toward the medicine cartridge120when the medicine cartridge120is inserted into the cavity116. In some embodiments, the plunger engagement device375may comprise a pusher disc that abuts against the plunger125of the medicine cartridge120.

Because the flexible piston rod370is adjustable from a curved shape to a noncurved shape, the overall length of the pump device can be reduced in some embodiments. For example, in a typical infusion pump that houses a straight and rigid rod, the typical infusion pump requires a package or housing having a linear dimension sufficient to accommodate the length of the rigid piston rod when it is at its limit of travel in which it is fully withdrawn from the container or cylinder. The pump device100incorporating the flexible piston rod370can require less space than a similar device that houses a non-flexible, rigid rod.

Referring now toFIG. 19, a block diagram of the pump system10illustrates the operation of some components of the pump device100and the controller device200. The controller device200is removably attached to the pump device100so as to form an electrical connection between connectors118and218(previously described inFIGS. 1 and 8). The controller device200includes the previously described processor243, memory device246, power source245, display222, and keypad buttons224a-d. Such components can be used to control the activation of the pump device100so as to dispense a medicine dosage to the user. For example, the processor243can execute pump operation instructions stored in the memory246in accordance with the pump settings (some of which can be adjusted by the user with the display222and keypad buttons224a-d). As such, the processor243can cause an activation signal to be sent from the controller device200to the actuator320in the pump device100. As previously described, the activation power for the actuator320can be provided from the power source245located in the controller device200.

In addition, the pump system10is a capable of providing media content playback while worn by the user and while dispensing medicine to the user. As shown inFIG. 19, this embodiment of the pump system includes the audio output232, which can be an audio jack for connection with an external audio device231(FIG. 4) or a wireless transmitter for communication with the audio earpiece235′ (FIG. 5). Also, the memory246housed in the controller device200can store a number of media content files. As previously described, the memory246can include a selected portion247athat is reserved for the storage of media content files. In addition, some embodiments of the pump system10include an external memory connector. In this embodiment, the external memory connector comprises the cable connector253for connection via the data cable252to a separate computer system, as previously described in connection withFIG. 7. Alternatively, the external memory connector may comprise the memory card port251for connection to with the removable memory card250, as previously described in connection withFIG. 6. Accordingly, the pump system10can be configured to permit the user to update or otherwise change the media content files that are stored in the memory246.

Referring now toFIGS. 20A-B, the pump system10can be configured to group a number of media content files into one or more playlists. In particular, the user can customize and save a playlist so that the playback system230will thereafter deliver the selected group of media content files when the playlist is activated. As previously described, the user interface220of the pump system10can include display numerals, text, symbols, images, or a combination thereof in order to communicate media content information to the user. For example, the display device222can be used to communicate a menu option in which the user can select particular media content file for assignment to a customized playlist. As shown inFIG. 20A, the display device222can display a list of media content files (e.g., MP3 music files in this embodiment) that are stored on the memory device246(FIG. 17). In this embodiment, the user may press the buttons224band224cto scroll through list of media content files. When the user encounters a song the that should added to the particular playlist (e.g., “Playlist 1” in this embodiment), the user can actuate the button224dpositioned adjacent to the “YES” indicator in the display222. A similar process can be used to remove selected media content files from a previously saved playlist.

As shown inFIG. 20B, the user can press one or more of the buttons224a-dto select menu options for the playback system230, including an option to playback a particular playlist (e.g., “Playlist 1” in this embodiment). As previously described, when the user activates the playback system230, the processor243can execute a media player software program stored in the memory device246so as to decode or otherwise retrieve one or more media content files and output signals via the audio jack232(refer toFIG. 17). The signals output from the audio jack232can include audio signals that cause the external audio device231to generate audible sounds indicative of the particular media content organized in the selected playlist. In this embodiment, the display device222may include a media content message (e.g., “Loading Playlist 1 . . . ” as shown, for example, inFIG. 20B) that indicates to the user that the media player has been activated to output the media content.

Referring now toFIGS. 21A-B, the media content stored in the memory246of the pump system10can include an instructional content that provides a tutorial on how to operate particular features of the system10. Such media content can be used to provide training to new users (especially for children or other users that may require additional training outside of a clinic). In this example, the instructional content can include an audio tutorial on how to prepare the pump system10for medicine dispensation after a new pump device100can be connected to the controller device200. As previously described in connection withFIGS. 11-16, the controller device can be reused with a new pump device100′ after a previously used pump device is emptied, expired, or otherwise exhausted. In such embodiments, the controller device200can detect when the new pump device100is connected thereto, and the display device222can be used to query whether the user would like to receive the audio tutorial. As shown inFIG. 21A, the display device222can prompt the user to indicate whether the audio tutorial (or other instructional content) should be delivered through the playback system230. The user can actuate the button224b(adjacent to the “No” indicator) to input that no audio tutorial should be played at this time. Alternatively, the user can actuate the button224c(adjacent to the “Yes” indicator) to input that the audio tutorial should be started. In some embodiments, the controller device200can be configured to automatically display the query screen222(as illustrated inFIG. 21A) for a limited period of time. For example, the query screen222(as illustrated inFIG. 21A) may be automatically displayed in response to the attachment of a new pump device only for a period of one month after the controller device200is initially activated. Accordingly, as the user becomes accustom to the operation of the pump system10over the period of the initial month, the user may no longer need to receive the playback of the audio tutorial for this particular feature.

As shown inFIG. 21B, when the user indicates that the audio tutorial should be played, the processor243can execute a media player software program stored in the memory device246so as to decode or otherwise retrieve the selected file containing the instructional content and output signals via the audio jack232(refer toFIG. 17). The signals output from the audio jack232can include audio signals that cause the external audio device231to generate voice instructions indicative of the selected tutorial. For example, the audio tutorial may provide voice instructions from the earbuds235that explain to the user how to attach the infusion set tubing147(compareFIG. 21AtoFIG. 21B) or how to prime the infusion set tubing that was previously attached. The media content stored in the memory246of the pump system10may include other audio tutorials that provide instructions related to, for example, inserting the infusion set into the skin site, setting a new basal rate, setting a time-based basal rate program, activating a bolus dose, calculating a bolus dose based upon food intake, downloading software updates for the controller device200, uploading historical dispensation data for review by a physician, periodically inspecting the pump system10, and other actions to be performed by the user.

Referring now toFIGS. 22-24, some embodiments of a portable infusion pump system400,500, and600having media player capabilities can employ a reusable pump apparatus (rather than a disposable pump device as previously described). In such circumstances, the infusion pump system400,500, and600may comprise a reusable device that houses the control circuitry and the pump drive system. Similar to previously described embodiments, the infusion pump system400,500, and600may also include an media content playback system430,530, and630that can playback media content to the user contemporaneously with the dispensation of medicine to the user. Accordingly, the user can operate the reusable pump device so as to receive controlled delivery of a medicine while also listening to the playback of selected MP3 music or other media content. As previously described, the pump system400,500, and600having the media content playback system430,530, and630may provide a compact, multi-purpose device that eliminates the need for the user to carry multiple devices (e.g., a medical pump device and a separate media player device). Also, the infusion pump system400,500, and600can enhance user safety by interrupting the music content or other media content in order to deliver an alarm to the user that might otherwise go unnoticed if the user was listening to a separate media player device.

In the particular embodiment depicted inFIG. 22, the pump system400comprises a reusable pump device that houses both the controller circuitry and the pump drive system. Similar to previously described embodiments, the pump system400can include a housing structure that defines a cavity in which a medicine cartridge can be received (not shown inFIG. 22; refer for example to cartridge120inFIG. 1). For example, the pump system400can 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 an infusion set146and into the user's tissue or vasculature. In this embodiment, the user can wear the portable pump system400on the user's skin under clothing or in the user's pocket while receiving the medicine dispensed through the infusion set146.

Still referring toFIG. 22, the infusion pump system400may also include a media content playback system430that can playback media content (e.g., music, voice instructions, audiobooks, audio that corresponds to a video being displayed, and other data) to the user while the pump system400is delivering the medicine to the user. Similar to previously described embodiments, the playback system430may comprise an external audio device431that plugs into a connection port along the pump housing so as to mate with an audio output device (e.g., an audio jack similar to the component232shown inFIG. 17). The external audio device431may include earbuds435or another listening device that deliver sound to the user's ear while the pump system400is carried by the user. At least one memory device arranged in the pump system400can be used to electronically store a number of media content files available for playback to the user. Accordingly, the user can operate a user interface420of the infusion pump system400so as to receive controlled delivery of a medicine while also listening to the playback of selected MP3 music or other media content.

In this embodiment, the user interface420includes a display device422and one or more user-selectable buttons424a-e. The display device422can include an active area in which numerals, text, symbols, images, or a combination thereof can be displayed (as shown, for example, inFIG. 22). For example, the display device422can be used to communicate media content information426, which may related to the selected media content that is being delivered to the user through the playback system430. Also, the display device422can be used to communicate a number of settings or menu options for the infusion pump system400. For example, the display device422can be used to communicate medicinal delivery information427, such as the basal delivery rate (as shown inFIG. 22), a bolus dosage, a historical record of medicine delivered, the amount of medicine remaining in the cartridge, or the like. In another example, the display device422can be used to communicate time and date information428, which can be used by the user to determine dosage schedules, bolus delivery times, meal times, or the like.

Accordingly, the user may press one or more of the buttons424a,424b,424c,424d, and424eto 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 the cartridge120, or the like). Also, the user can adjust the settings or otherwise program the pump system400by pressing one or more buttons424a,424b,424c,424d, and424eof the user interface420. Furthermore, the user can press one or more of the buttons424a,424b,424c,424d, and424eso as to play, pause, rewind, or fast-forward the selected media content426or to otherwise control the output of media content through the playback system430. Thus, the user can contemporaneously monitor the operation of the pump system400and control the media content playback from the same user interface420. Similar to previously described embodiments, the pump system400can be configured to interrupt the music content or other media content in order to deliver an alarm via the user's external audio device431(e.g., earbud device, other headphone device, or the like), thereby enhancing the user safety. Finally, the media content played by the pump system400may include an audio tutorial or other instructional content on how to operate particular features of the system, which facilitates new user training.

Referring now to the particular embodiment depicted inFIG. 23, the pump system500comprises a reusable pump device that houses both the controller circuitry and the pump drive system. Similar to previously described embodiments, the pump system500can include a housing structure that defines a cavity in which a medicine cartridge can be received. For example, the pump system500can 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 an infusion set146and into the user's tissue or vasculature. Again, the user can wear the portable pump system500on the user's skin under clothing or in the user's pocket while receiving the medicine dispensed through the infusion set146.

The infusion pump system500may also include a media content playback system530that can playback media content to the user while the pump system500is delivering the medicine to the user. Similar to previously described embodiments, the playback system530may comprise an external audio device531that plugs into a connection port along the pump housing so as to mate with an audio output device (e.g., an audio jack or the like). The external audio device531may include earbuds535or another listening device that deliver sound to the user's ear while the pump system500is carried by the user. At least one memory device arranged in the pump system500can be used to electronically store a number of media content files available for playback to the user. Accordingly, the user can operate a user interface520of the infusion pump system500so as to receive controlled delivery of a medicine while also listening to the playback of selected MP3 music or other media content.

Still referring toFIG. 23, the user interface520includes a display device522and one or more user-selectable buttons524a-c. The display device522can include an active area in which numerals, text, symbols, images, or a combination thereof can be displayed. For example, the display device522can be used to communicate media content information526, which may related to the selected media content that is being delivered to the user through the playback system530. Also, the display device522can be used to communicate a number of settings or menu options for the infusion pump system500. For example, the display device522can be used to communicate medicinal delivery information527, such as the basal delivery rate (as shown inFIG. 23) or the like. In another example, the display device522can be used to communicate time and date information528. Similar to previously described embodiments, the user may press one or more of the buttons524a,524b, and524cto shuffle through a number of menus or program screens that show particular settings and data related to the medicine dispensation. Also, the user can adjust the settings or otherwise program the pump system500by pressing one or more buttons524a,524b, and524cof the user interface520. Furthermore, the user can press one or more of the buttons524a,524b, and524cso as to play, pause, rewind, or fast-forward the selected media content526or to otherwise control the output of media content through the playback system530. Accordingly, the user can contemporaneously monitor the operation of the pump system500and control the media content playback from the same user interface520. Similar to previously described embodiments, the pump system500can be configured to interrupt the music content or other media content in order to deliver an alarm via the user's external audio device531, thereby enhancing the user safety. Also, the media content played by the pump system500may include an audio tutorial or other instructional content on how to operate particular features of the system, which facilitates new user training.

Referring now toFIG. 24, the pump system600comprises a reusable pump device that houses both the controller circuitry and the pump drive system. Similar to previously described embodiments, the pump system600can include a housing structure that defines a cavity in which a medicine cartridge can be received. For example, the pump system600can 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 an infusion set146and into the user's tissue or vasculature. The user can wear the portable pump system600on the user's skin under clothing or in the user's pocket while receiving the medicine dispensed through the infusion set146.

The infusion pump system600in this embodiment also includes a media content playback system630that can playback media content to the user while the pump system600is delivering the medicine to the user. Similar to previously described embodiments, the playback system630may comprise an external audio device631that plugs into a connection port along the pump housing so as to mate with an audio output device (e.g., an audio jack or the like). The external audio device531may include earbuds635or another listening device that deliver sound to the user's ear while the pump system600is carried by the user. At least one memory device arranged in the pump system600can be used to electronically store a number of media content files available for playback to the user. Accordingly, the user can operate a user interface620of the infusion pump system600so as to receive controlled delivery of a medicine while also listening to the playback of selected MP3 music or other media content.

Still referring toFIG. 24, the user interface620includes a display device622and one or more user-selectable buttons624aand624b. The display device622can include an active area in which numerals, text, symbols, images, or a combination thereof can be displayed. For example, the display device622can be used to communicate media content information626, which may related to the selected media content that is being delivered to the user through the playback system630. Also, the display device622can be used to communicate medicinal delivery information627, such as the basal delivery rate (as shown inFIG. 24) or the like. Similar to previously described embodiments, the user may press one or more of the buttons624aand624bto shuffle through a number of menus or program screens that show particular settings and data related to the medicine dispensation. Also, the user can adjust the settings or otherwise program the pump system600by pressing one or more buttons624aand624bof the user interface620. In another example, the user can press one or more of the buttons624aand624bso as to play, pause, rewind, or fast-forward the selected media content626or to otherwise control the output of media content through the playback system630. Accordingly, the user can contemporaneously monitor the operation of the pump system600and control the media content playback from the same user interface620. Similar to previously described embodiments, the pump system600can be configured to interrupt the music content or other media content in order to deliver an alarm via the user's external audio device631, thereby enhancing the user safety. Also, the media content played by the pump system600may include an audio tutorial or other instructional content on how to operate particular features of the system, which facilitates new user training.

Referring now toFIG. 25, the infusion pump system10depicted inFIGS. 1-3can be configured to interrupt the playback of media content when an alarm condition has been detected. As such, the pump system10can execute a process700that communicates the alarm condition to the user. It should be understood from the description herein that the system400,500, and600can also be configured to operate as described inFIG. 25so as to interrupt the playback of media content when an alarm condition has been detected.

The process700includes the operation710of operating the infusion pump according to the set parameters. For example, during normal usage, the pump device can dispense the medicine to the user in a controlled manner according to a selected basal rate. In operation720, an alarm condition is detected by the infusion pump system. As previously described, the alarm condition may comprise an occlusion in the infusion set tubing147, low battery power, low medicine remaining in the cartridge, a missed bolus dosage, or the like.

As shown inFIG. 25, the infusion pump system10can perform operation730so as to determine whether media content is being delivered to the user via an audio device. For example, the control circuitry can be equipped to detect whether the external audio device231is plugged into the audio jack232(refer toFIG. 17). In addition or in the alternative, the control circuitry can be used to determine whether the media content playback software has been activate to deliver media content to the user. If the operation730reveals that the media content is being delivered to the user, the process700proceeds to operation740in which the playback is interrupted to provide an audible alert via the audio device (e.g., a beep or voice warning is communicated via the earbuds235or the like). Alternatively, if the operation730reveals that no media content is being delivered, the pump system10proceeds to operation760in which an alert (e.g., an audible beep, a vibration alarm, a display alarm, or the like) external to the audio device is provided to the user.

Referring again to operation740, after the playback of the media content has been interrupted to provide the alert, the process700proceeds to operation750in order to determine if the alarm has been acknowledged, cleared, or otherwise resolved by the user. For example, as previously described in connection withFIG. 3, the user can actuate a button on the user interface220to acknowledge that the alarm was received. If the alarm is acknowledge or otherwise resolved, the process700cycles back to operation710where the pump system10functions according to the set parameters. If the alarm is not acknowledge or otherwise resolved, the process700can proceed to previously described operation760in which an alert (e.g., an audible beep, a vibration alarm, a display alarm, or the like) external to the audio device is provided to the user.

If the process reaches operation760to provide the alert external to the audio device, the process then determines in operation770if the alarm was acknowledged, cleared, or otherwise resolved by the user. If yes, the process700cycles back to operation710where the pump system10functions according to the set parameters. However, if the alarm has not been acknowledged or otherwise resolved, the process700proceeds to operation780in which the pump system10begins to operate in an emergency mode. The emergency mode can include a number of different operations depending upon the alarm condition that was detected. For example, the emergency mode may comprise a series of incrementally louder alarms that are intended to be heard from a distance away from the pump system (e.g., to get attention from others near the user). In another example, the emergency mode may comprise a shutdown of non-medical features so as to preserve the remaining battery power for medicine dispensation purposes. If the alarm condition is subsequently resolved, the user may operate the user interface220so as to return the pump system10to normal operation according to the set parameters.

Referring now toFIG. 26, the infusion pump system10depicted inFIGS. 1-3can be configured to provide instruction media content to the user in response to a detected event. As such, the pump system10can execute a process800that permits a new user to readily receive a tutorial or other instructions related to the pump system10. It should be understood from the description herein that the system400,500, and600can also be configured to operate as described inFIG. 26so as to provide instruction media content to the user.

The process800includes the operation810of detecting an event, such as the startup of a new pump device in this particular embodiment. Thereafter, the process800proceeds to operation820in which the user is prompted to indicate if instructional media content should be delivered to the user. The instruction media content can be related to the detected event. For example, in this embodiment the event is the startup of a new pump device. As such, the instructional media content may comprise an audio tutorial that relates to the preparation of the new pump device in order to begin dispensing medicine to the user. In operation830, the pump system10receives user input that indicates if the instructional media content should be played (e.g., playback through the external audio device231). If the user indicates “no,” the instructional content is not provided and the process800proceeds to operation860in which the pump system delivers medicine according to set parameters. Alternatively, if the user indicates “yes,” the process800continues to operation840so that the instructional content is output via an audio device (e.g., external audio device231having earbuds or the like). In such circumstances, the playback system230can provide verbal instructions to the user.

After the instructional content is provided, the process800may proceed to operation850to query the user on whether the instruction content was properly received. If “no,” the process800cycles back to operation830to determine if the instructional media content should be played to the user. If the user indicates “yes” for operation850, the process800proceeds to operation860in which the pump system delivers medicine according to set parameters.