Source: https://patents.google.com/patent/EP2365452A2/en
Timestamp: 2018-10-15 23:40:12
Document Index: 209462005

Matched Legal Cases: ['art 106', 'art 108', 'art 106', 'Application No. 60', 'Application No. 60', 'art 106', 'art 108', 'art 106', 'art 108', 'art 106', 'art 108', 'art 108', 'art 106', 'art 108', 'art 108', 'art 106', 'art 106', 'art 108', 'art 106', 'art 108', 'art 106', 'art 108', 'art 108', 'art 108', 'art 106', 'art 108', 'art 108', 'art 106', 'art 106', 'art 106', 'art 108', 'art 106', 'art 108', 'art 106', 'art 106', 'art 106', 'art 108', 'art 600', 'art 700', 'art 800', 'art 900', 'art 108', 'art 106', 'art 108', 'art 106', 'art 108', 'art 108', 'art 106', 'art 106', 'art 108', 'art 106', 'art 106', 'art 106', 'art 108', 'art 106', 'art 106']

EP2365452A2 - Fluid delivery device and methods of its operation - Google Patents
EP2365452A3 (en )
A method (800) for communicating between a dispensing unit of a fluid delivery device and a paired command means, comprises:
sending (802) a communication message from the dispensing unit at a beginning of a current communication cycle;
enabling (804), for a limited period of a time, a wireless receiver provided on the dispensing unit;
handling (810) an incoming message if the incoming message is received from the paired command means during the limited period of time; and
waiting (820) for a next communication cycle to send a next communication message from the dispensing unit.
This application claims the priority of United States Provisional Application Serial Nos. 60/819,336, filed July 7, 2006 and entitled "System and Methods of Operation of a Medicinal Fluid Delivery System," and 60/819,356, filed July 8, 2006 and entitled "Systems and Methods of Communications of a Medicinal Fluid Delivery System," the disclosures of which are hereby incorporated by reference in their entireties.
Several ambulatory insulin infusion devices are currently available. These devices generally have two portions: a reusable portion that contains a dispenser, a controller and electronics, and a disposable portion that contains a syringe-type reservoir, a needle assembly with a cannula and a penetrating member, and a fluid delivery tube. In use, a patient typically fills the reservoir with insulin, attaches the needle and the delivery tube to the exit port of the reservoir, and then inserts the reservoir into the pump housing. After purging air out of the reservoir, tube and needle, the patient inserts the needle assembly, that includes the penetrating member and cannula, at a selected location on the body and withdraws the penetrating member. To avoid irritation and infection, the subcutaneous cannula is usually replaced and discarded after a relatively short period of time, such as two to three days, together with the empty reservoir . Examples of first generation disposable syringe-type reservoir and tubes were disclosed in U.S. Patent No. 3,631,847 to Hobbs , U.S. Patent No. 3,771,694 to Kaminski , U.S. Patent No. 4,657,486 to Stempfle , and U.S. Patent No. 4,544,369 to Skakoon . The driving mechanism of these devices can be a screw thread driven plunger controlling the programmed movement of a syringe piston. Other dispensing mechanisms have been also discussed, including peristaltic positive displacement pumps, in U.S. Patent No. 4,498,843 to Schneider and U.S. Patent No. 4,715,786 to Wolff . These devices are generally fairly large and heavy due to the configuration and the relatively large size of the driving mechanism of the syringe and the piston. This relatively bulky device is generally carried in a patient's pocket or attached to the belt. Consequently, the fluid delivery tube is typically quite long, usually longer than 60 cm, in order to permit needle insertion at remote sites of the body. Such uncomfortable, bulky devices with a long tube are rejected by many diabetic insulin users, since they disturb regular activities, such as sleeping and swimming. Furthermore, the effect of the image projected on the teenagers' body is unacceptable. In addition, the delivery tube excludes some optional remote insertion sites, like buttocks, arms and legs.
Recently, remote controlled, skin adherable delivery devices have been introduced. Such a device generally includes a housing with a bottom surface adapted to contact a patient's skin, a reservoir disposed within the housing, and an injection needle adapted to communicate with the reservoir. These skin adherable devices also should be discarded on a relatively short duty cycle such as every two to three days for similar reasons to those discussed above for pump infusion sets. Such adherable devices have been disclosed in U.S. Patent No. 5,957,895 to Sage , U.S. Patent No. 6,589,229 to Connelly , and U.S. Patent No. 6,740,059 to Flaherty . Additional configurations of skin adherable pumps have been disclosed in U.S. Patent No. 6,723,072 to Flaherty and U.S. Patent No. 6,485,461. to Mason . In general, these devices can be relatively bulky and expensive. Their high selling price is due to high production and accessory costs as well as the typical requirement that a user must discard the entire device, which typically includes relatively expensive components such as a driving mechanism and other electronics, every two to three days, including.
Additional advantages in reduction of manufacturing costs and reduction of dispensing unit size can also be realized due to the use of mirrored logbooks on the command means and the dispensing unit. Because the dispensing unit or at least a portion of the dispensing unit, such as for example a reusable part) can optionally be discardable on a relatively short time span, such as for example a few months, use of high capacity data storage components on the dispensing unit can increase costs and dimensions. The subject matter disclosed herein can allow use of a small capacity memory on the dispensing unit for storage of logbook data entries for a short period of time until these logbook data entries can be communicated to a command means that includes a larger capacity memory that stores a more complete version of the logbook such as for example on a flash memory. Use of a larger capacity, more expensive memory on the command means is more cost effective because the command means can generally be more durable and therefore usable for a much longer period of time than the dispensing unit, such as for example a few years. Transfer of data packets from the small capacity dispensing unit logbook can occur as space in data packets sent from the dispensing unit is available. Data packets sent from the dispensing unit can be limited in size to minimize unnecessary communication bandwidth. For example, a relatively long data logbook entry can be divided into various data packets which are shorter than the original data, and can be communicated in several communication cycles according to available space in communicated data packets. These approaches can provide communication efficiency advantages in addition to possible power saving, size reduction, and other advantages.
In a third interrelated aspect, communication between a dispensing unit of a fluid delivery device and a paired command means, can include sending a communication message from the dispensing unit at a beginning of a current communication cycle and then enabling, for a limited period of a time, a wireless receiver provided on the dispensing unit The dispensing unit can handle an incoming message if the incoming message is received from the paired command means during the limited period of time. The dispensing unit can then wait for a next communication cycle to send a next communication message from the dispensing unit.
The following optional features can be included in this aspect either individually or in combination. Handling of status data can include retrieving new logbook entries included in the status message received from the dispensing unit The command means can send one or more new messages to the paired dispensing unit or send a stop communication message and ending communication if no messages need to be sent. The command means can increment a count of failed communication cycles since a last successful receipt of an incoming message if no status message is received from the dispensing unit and end communication if the count exceeds a threshold.
In a fifth interrelated aspect, a fluid delivery logbook can be maintained on a dispensing unit of a fluid delivery device. At the start of a current communication cycle, the dispensing unit can generate a dispensing unit status message and add unacknowledged logbook entries to the dispensing unit status message if a logbook on the dispensing unit comprises entries that have not been acknowledged by a command means paired to the dispensing unit. The dispensing unit can send the dispensing unit status message also record receipt of the logbook entries sent in the dispensing unit status message by the commands means if an acknowledgment message is received from the command means. The dispensing unit can wait until a next communication cycle before initiating further communication.
Fig. 6. is a process flow diagram illustrating a method for pairing a remote control unit with a dispensing unit on the dispensing unit side;
Next generation skin adherable dispensing patch units have been developed to address price issues and patient comfort and customization issues. Example of such devices are discussed in co-pending/co-owned U.S. Patent Application Serial No. 11/397,115 and International Patent Application No. PCT/IL06/001276 , the disclosures of which are incorporated herein by reference in their entireties. One such device is a dispensing unit having two parts: a reusable part that contains driving and pumping mechanisms, electronics, and other relatively expensive components, and a disposable part that contains less expensive, discardable components such as a fluid reservoir, tubes, and batteries.
This concept provides the possibility for a cost-effective, skin adherable infusion device and allows diverse usage of the device, e.g. the use of various reservoir sizes, various needle and cannula types and implementation of versatile operational modes. This generation of infusion pumps allows for various applicable types of pumping mechanisms for the two-part device configuration. A preferred delivery mechanism is the peristaltic positive displacement pumping mechanism also discussed in co-pending/co-owned U.S. Patent Application Serial No. 11/397,115 and International Patent Application No. PCT/IL06/001276 . Alternative driving mechanisms, which can be applied in any one of the various pumping mechanisms, may include DC motor, stepper motor, Shape Memory Alloy (SMA) actuator, etc.
FIG 1A shows an example of a medicinal fluid delivery system 100 that includes a dispensing unit 102 and a remote control unit 104. In one implementation shown in FIG 1B, the dispensing unit 102 can be a single part. Alternatively, as shown in FIG 1C, the dispensing unit 102 can include two parts: a reusable part 106 and a disposable part 108 that is detachably connectable to the reusable part 106. The dispensing unit 102 can employ different dispensing mechanisms, such as for example a syringe-type reservoir with a propelling plunger, peristaltic positive displacement pumps, and the like. In some variations, the dispensing unit 102 can be adhered to the patient's body. Such an adherable dispensing unit 102 can optionally be attached to the patient's body by direct adherence to the skin, using a well arrangement as disclosed in co-pending U.S Provisional Patent Application No. 60/833,110 , or via a cradle unit as disclosed in co-pending U.S. Provisional Patent Application No. 60/876,679 , or by other attachment techniques and/or methods.
FIG. 2A and FIG 2B show more detailed diagrams of dispensing units 102 employing a peristaltic pump 207 for dispensing the fluid to a user's body. FIG 2A shows a single-part dispensing unit 102. The fluid is delivered from a reservoir 202 provided in the dispensing unit 102 through a delivery tube 204 to an exit port 206. The peristaltic pump 207 in FIG 2A includes a rotary wheel 208 provided with rollers (not shown) and a stator 210. Rotation of the wheel 208 and pressing of the rollers against the stator 210 periodically positively displaces fluid within the delivery tube 204 by virtue of a peristaltic motion.
An example of such a positive displacement pump is disclosed in co-pending U.S. Patent Application Serial No. 11/397,115 . A driving mechanism 212 including a gear and a motor, such as for example a stepper motor, a DC motor, SMA actuator or the like, can be used to rotate the rotary wheel 208. The driving mechanism 212 can be controlled by electronic components 214 residing in the dispensing unit 102. These electronic components 214 can include a controller 216 that can be a microprocessor capable of executing control software such as is described below, a transceiver 217, and the like. An energy source 218, such as for example one or more batteries, a fuel cell, a photovoltaic cell or the like, can also be included in the dispensing unit 102 in FIG 2A. Infusion programming of the dispensing unit 102 can be carried out by a remote control unit 104 capable of establishing a bidirectional communication link with the transceiver 217. provided in the dispensing unit 102. In an optional implementation, the infusion programming can also or alternatively be carried out via one or more manual buttons 220 provided on the patch unit 102.
FIG. 2B shows a two-part dispensing unit 102 that includes a reusable part 106 and a disposable part 108. The reusable part 106 includes a rotary wheel 208 and driving mechanism 212 that form part of a positive displacement pump mechanism 213, and electronic components 214 that can include a controller 216 that can be a microprocessor capable of executing control software such as is described below, a transceiver 217, and the like. The disposable part 108 of FIG 2B includes a fluid reservoir 202, a delivery tube 204, an energy source 218, an exit port 206 and a stator 210. Pumping is possible after connecting the reusable part 106 with disposable part 108. This arrangement is described in our co-pending U.S. Patent Application Serial No. 11/397,115 . The power source 218, such as for example a battery, a fuel cell, a photovoltaic cell, or the like, can be included in the disposable part 108 as shown. Alternatively, the power source 218 can be included in the reusable part 106.
In some variations, the dispensing unit 102 can be configured to deliver more than one medicinal fluid. More than one disposable part 108, each including a reservoir. 202 for a different fluid can then be included. Alternatively, a single disposable part 108 can include more than one reservoir. For delivery of multiple medicinal fluids from one device, the reusable part 106 can include more than one pumping mechanism 213, or alternatively a single pumping mechanism 213 can sequentially deliver each medicinal fluid or can draw medicinal fluids from more than one reservoir 202 simultaneously. Additional tubing, valves, or the like can be included as necessary to implement such a multiple fluid delivery system.
FIG 3A and FIG 3B are schematic diagrams showing an implementation of a two-part dispensing unit 102. FIG 3A shows the two parts in detail. The reusable part 106 includes a positive displacement pump provided with a rotary wheel 208, a driving mechanism 212 and electronic components 214 on a circuit board. The disposable part 108 includes a reservoir 202, a delivery tube 204, an energy source 218, an exit port 206, and a stator 210. FIG 3B shows the reusable part 106 and the disposable part 108 connected and ready for operation. In optional variations, the pumping mechanism can be of syringe-type, piezoelectric or the like.
FIG 4A and FIG 4B show an implementation of the dispensing unit 102 employing a syringe pump for dispensing fluid to a user's body. FIG 4A shows a single-part dispensing unit 102. The fluid is delivered from a reservoir 202 to the exit port 206. The reservoir 202 is provided with a plunger 209, which urges the fluid towards the exit port 206. A driving mechanism 212 is provided, which can include a motor, such as for example a stepper motor, DC motor, SMA actuator or the like, and a driving gear for driving the plunger 209. The driving mechanism 212 is controlled by electronics 214 which can include a controller 216, such as a microprocessor, and a transceiver 217. An energy source 218 is also provided such as is described above. Infusion programming can be carried out by a remote control unit 104 and/or by one or more buttons 220. optionally provided on the dispensing unit 102.
FIG 4B shows a two-part dispensing unit 102 that includes a reusable part 106 and a disposable part 108 employing a pumping mechanism, which is a positive displacement pump. The reusable part 108 comprises driving mechanism 212, such as for example a motor and gear, electronic components 214, and at least one button 220. The disposable part 108 includes a reservoir 202 provided with plunger 209, energy supply means 218, and exit port 206. In optional variations, the plunger 209 can be located in the reusable part 106 or in the disposable part 108. If the plunger 209 is included in the disposable part 108, it can be configured to mate with the driving mechanism 212 on the reusable part 106. Infusion programming can optionally be carried out by a remote control unit 104 and/or by one or more buttons 220 optionally provided on the reusable part 106. Fluid dispensing is possible upon connecting the reusable part 106 with disposable part 108.
Control of the dispensing unit 102 can be accomplished by a user interface that can be manifested through input controls 220 on the dispensing unit 102. Such input controls 220 can optionally be positioned as shown in FIG. 2B, FIG 3A, FIG. 3B, and FIG 4B on the reusable part 106 or optionally on the disposable part 108. Control of the dispensing unit 102 can also be performed via wired or wireless communications with a remote control unit 104, a computer, or some other command means capable of relaying commands to the controller 216 on the reusable part 106. For wireless communication with a remote control unit 104 or other command means, the dispensing unit 102 can have an antenna or other wireless transceiver 217 that can be included either internally or externally on the reusable part 106.
FIG. 5 is a relationship diagram 500 that illustrates various communication and control relationships of a medicinal fluid delivery device. As shown, a dispensing unit 102 that includes a reusable part 106 and a disposable part 108 can receive commands from a remote control unit 104, or in some variations from a test PC 502. The remote control unit 104 can provide commands related to dispensing unit 102 operation, and can receive the dispensing unit 102 status and logbook feedback as described in greater detail below. The test PC 502 can provide simulated commands to the dispensing unit 102 via a cable or a wireless communication link, and can receive debug data and logbook entries from the dispensing unit 102. The test PC 502 and remote control unit 104 can communicate either wirelessly or via a cable to exchange simulated commands and/or to download logbook entries. The remote control unit 104 can also optionally communicate either via wired or wireless communication links with one or more other PCs 504 that can optionally include a user PC and/or a physician PC, for example. Settings for dispensing unit 102 operation optionally including but not limited to medicinal fluid delivery settings can be sent to the remote control unit 104 and medicinal fluid delivery data (such as for example the logbook) and settings data can be transmitted to the PCs 502, 504. A technician PC 506 can also communicate with the remote control unit 104 via a wired or wireless link to exchange logbook data, settings information, to reset a password, and the like. One or more of a test PC, a user or physician PC 504, a technician PC 506, or a patient's computer or portable communication device operating specially adapted software can optionally perform one or more of the functions described here for the remote control unit 104. References to a remote control unit 104 herein are intended to cover these alternatives and other comparable devices, which are referred-to further by a general term command means.
FIG 6 is a process flow chart 600 illustrating an example of a pairing method between a dispensing unit 102 and a remote control unit 104 from the dispensing unit 102 side. At 602, a communication cycle begins for an unpaired dispensing unit 102. The controller 216 on the dispensing unit 102 can also optionally perform testing for software faults at this stage. At 604, the dispensing unit 102 sends an unpaired status message, optionally via its transmitter 217, and at 606 waits for a message from a remote control unit 104, such as for example an "accept dispensing unit" message, that indicates that the remote control unit 104 has received the unpaired status message sent at 604. At 610, the dispensing unit 102 controller 216 determines whether an "accept dispensing unit" message has been received. If no such message has been received, the dispensing unit 102 waits for the next communication cycle at 612 and then restarts the process at 602. When incoming messages from remote control units are received, the dispensing unit 102 determines whether the incoming messages have protocol and/or software versions that are compatible with those of the dispensing unit 102 at 610. The dispensing unit 102 software can also optionally verify the data integrity for data received from the remote control unit 104, such as for example by means of a cyclic redundancy check (CRC). If the protocol and software versions are not compatible, the dispensing unit 102 waits for the next communication cycle at 612 before beginning a new communication cycle at 602. If the protocol and software versions are compatible, an identification for the remote control unit 104 is saved by the dispensing unit 102 at 616. This completes the pairing process at 620. The dispensing unit 102 can send an acknowledgement message to the remote control unit 104 to confirm the pairing on the next communication cycle after the pairing has been completed.
FIG 7 is a process flow chart 700 illustrating an example of a method for pairing a remote control unit 104 with a new dispensing unit 102 from the remote control unit 104 side. A dispensing unit 102 replacement sequence is started at 702 upon receipt of a command from a user, such as for example via a user interface on the remote control unit 104. The remote control unit 104 waits for a user to enter a designation code corresponding to a selected dispensing unit 102. The designation code can optionally be a complete serial number or other code that corresponds to a selected dispensing unit. Alternatively, the code entered by the user can optionally be a truncated version of a full designation code or a hash code that is convertable by one or more mathematical or lookup table functions to the full designation code. The remote control unit 104 then waits for receipt of an unpaired status message from the dispensing unit 102 at 706. A710, if an unpaired status message has been received from the dispensing unit 102, the remote control unit 104 determines at 712 whether the message is compatible with the designation code entered by the user. If no such message is received at 710, the remote control unit 104 continues to wait for an unpaired status message from an unpaired dispensing unit 102 at 706. If the loop between stages 710 and 706 persists for longer than a threshold time, the remote control unit 102 can optionally end the pairing process. If the unpaired status message is compatible with the designation code entered by the user and is therefore available for pairing at 714 the remote control unit 104 sends an "accept dispensing unit" message or comparable notification to the dispensing unit 102. If the unpaired status message is not compatible with the designation code entered by the user at 712, the remote control unit returns to 704 to wait for a new dispensing unit 102 dispensing code to be entered by the user. If the waiting time persists for longer than a programmed threshold time, the process can optionally end. If the remote control unit 104 receives an acknowledgment to the "accept dispensing unit" message from the dispensing unit 102 at 716, the dispensing unit identification is saved at 722 and the process ends at 724. The programmed threshold waiting time can in one example be approximately as long as the duration of one or more communication cycles. If the pairing is not successful, for example if no acknowledgment is received from the dispensing unit 102, the process ends at 724 and should be repeated by the user.
In another implementation, a method is provided for communication between a dispensing unit 102 and a remote control unit 104. FIG 8 is a process flow chart 800 illustrating an example of such a method from the dispensing unit 102 side. In this example, communication between the dispensing unit 102 and the remote control unit 104 is initiated by the dispensing unit 102 at 801. The dispensing unit 102 sends a communication message at 802 and then enables a radio frequency or other wireless receiver on or in the dispensing unit 102 for a limited period of time at 804. Optionally, if the dispensing unit 102 is in wired contact with a remote control unit 104 or other command means, the communication message at 802 can also be sent via the wired connection.
If a message is received by the dispensing unit 102 from a paired remote control unit 104 at 806, the general handling of the incoming message is performed by the dispensing unit 102 controller 216 at 810. General message handling 810 can optionally include handling logbook entries such as is descried below in regards to FIG 10 and FIG. 11. Other general message handling aspects can optionally include time updates of remote control unit 104 and/or checking of software versions. During general message handling, the message from the paired remote control unit 104 is checked for whether it is a stop communication message at 812. If the message is a stop communication message, the communication process ends at 814. If the message is not a stop communication message at 812, the controller 216 on the dispensing unit 102 performs specific message handling at 816. This specific message handling can optionally include one or more of determining a pairing, suspend state, or drug delivery state, whether bolus commands have been given or basal profile programming changes made, or the like. After specific message handling, the dispensing unit waits for the next communication cycle at 820 before sending another communication message at 802.
FIG 9 is a process flow chart 900 illustrating a method for communication between a dispensing unit 102 and a remote control unit 104 from the remote control unit 104 side. In this example, a user initiates communication at 902. Communication can optionally be initiated by pressing a switch on the remote control unit 104, by entering a start communication command via the remote control unit 104 user interface, in response to a timer that is set to initiate communication at some programmed or independently generated time interval, or the like. The remote control unit 104 waits for a status message from a dispensing unit 102 that is paired to the remote control unit 104 at 904. If a status message is received from the paired dispensing unit 102 at 906, the status data in the status message is handled by the remote control unit 104. This status message handling 910 can optionally include retrieving new dispensing unit 102 logbook entries received in the status message. If no acknowledgment is received with regard to the status message which was sent previously, the remote control unit 104 resends the previous message to the paired dispensing unit 102 at 914 and then waits for a status message from the paired device at 904. Alternatively, if the remote control unit 104 has unsent messages to send to the paired dispensing unit 102 at 912, the remote control unit 104 sends a message to the paired dispensing unit 102 at 914 and then waits for a status message from the paired device at 904. If no status message is received from a paired dispensing unit 102 at 906, the remote control unit 104 determines whether the number of failed communication cycles has exceeded a programmed threshold at 916. If the threshold has not been exceeded at 916, the remote control unit 104 returns to 904 to wait for a status message from the paired dispensing unit 102. If the number of failed communication cycles does exceed the threshold at 916, the communication sequences ends at 920. If the remote control unit 104 does not have any messages to send to the paired dispensing unit 102 at 912, the remote control unit 104 can send a stop communication message to the dispensing unit 102 at 922 and end the communication sequence at 920.
In another implementation, methods are provided for keeping and synchronizing logbook entries between a dispensing unit 102 and a remote control unit 104. The dispensing unit 102 controller 216 can maintain the system time and keep a timestamp within its logbook. The control software can also maintain, among other possible records, a disposable part 108 operation time record. This record can track elapsed time since the previous reusable part 106 startup event The disposable part 108 time record can optionally include a logbook timestamp. In general the dispensing unit 102 logbook can includes items that are not yet known to the logbook maintained by the remote control unit 104. These items can include but are not limited to information regarding malfunctions of various parts of the dispensing unit, either on the reusable part 106 or the disposable part 108, and manual scheduling or termination of event such as boluses that are not commanded via the remote control unit 104 user interface. The software can further optionally maintain records of dispensing unit 102 operation hours (or other measure of operation time), disposable part battery voltage (or other measures of remaining power supply 218 capacity), disposable part 108 reservoir 202 level, and the like in the flash memory. For each dispensing unit 102 operation time change, if the reusable part 106 is paired within a drug delivery or drug delivery suspend state, the software can increment a reusable part 106 operation time elapsed counter and update the battery or power supply 218 voltage and reservoir 202 level records. During basal drug delivery calculations; the software can use the relative system time in conjunction with the timestamp for locating the basal profile entry and temporary basal entry that correspond to the current system time. If a disposable part 108 is attached to a reusable part 106 for too many hours the software can set a reusable part 106 error.
Optionally, when a communication cycle with a paired remote control unit 104 ends, the local logbook on the dispensing unit 102 can be cleared. For example, if all of the logbook entries were sent to the remote control unit 104 and acknowledgement received at 1012, and if there are no errors in the logbook and the number of logbook entries is above some hold that has been programmed to trigger an automatic clearing of the logbook, the device logbook can be cleared.
In various implementations, handling of errors identified by the control software and/or adding of logbook entries can be addressed using one or more features of the control software. Upon detecting an error in either the reusable part 106 or the disposable part 108 of the dispensing unit 102, the control software can add a logbook entry containing the error/ alarm event and the time that it occurred. The time can optionally be either absolute time or time elapsed since some milestone event such as the most recent reusable part 106 startup. If the logbook is nearing full capacity, for example if storage remains available for only a limited number of additional entries, the software can set a flag or other indicator of this condition to warn a user. If an error is detected, the software can set an error flag or set a state indicator to, communicate information about the error to a user.
If the dispensing unit 102 receives a remote control unit 104 fluid delivery suspend command, it can suspend all fluid delivery, both bolus and basal. During this state the software can be programmed to reject user certain commands entered via the dispensing unit 102 or remote control unit 104, including but not limited to stop and start bolus injection commands. During this state the software can disable any fluid deliver. Upon receiving a fluid delivery resume or a start bolus injection message from a paired remote control unit 104, the software can change the device state to the fluid delivery state and resume fluid delivery immediately. Upon receiving a user entered bolus command, from the remote control unit 104, the software can change to the fluid delivery state and resume fluid delivery.
Implementations of the presently disclosed subject matter can optionally include one or more safety features. For example, the software can be programmed to detect and discard illegal operator commands and/or to ignore messages from any other remote control unit 104 besides a remote control unit 104 that has been specifically paired with the dispensing unit 102. The software can also optionally handle all software, errors in an exception handler. The software can also detect errors using continuous tests throughout the operation period. The software can also continuously check the battery or power supply 218 level. If a battery level is below a minimum level, the so can set an error. Upon detection of an error or a state in which the software is not fully and properly initialized, the software can be configured to disable or otherwise suspend delivery of the medicinal fluid. The dispensing unit 102 software can reset itself by use of a watchdog times interrupt. In some variations, the dispensing unit 102 software can clear the timer periodically at a pro-determined time interval to prevent an inadvertent software reset. After an unrecoverable error, the dispensing unit 102 can be locked out from drug delivery operations. During this state, the software can stop both of basal and bolus drug delivery, and reject certain remote control unit 104 messages. User commands entered via the manual buttons 220 can also be rejected. Periodic auditory, visual, or other indications can be provided to alert the user of the error state. In one variation, when a user presses a key combination that is not in accordance with a command recognition specification or that is otherwise not understood by the user interface, the software can ignore the key press and set an auditory, visual, or other feedback indication to the user. Errors that can be detected by the control software can include, but are not limited to, BIT errors occurring in either the reusable or the disposable parts of the dispensing unit 102, maximum operation time exceeded errors for either the reusable/disposable part alone or for an assembled device including a single disposable part /reservoir module, pump motor errors, software errors (e.g. logbook full, etc.), errors reported by a continuous test routine, watchdog errors, an empty fluid reservoir 202 error, low battery or power supply 218 errors, and blockage errors related to the fluid delivery path.
In various implementations, the dispensing unit transceiver 217 can be an RF modem for example a Chipcon TBD - CC1110 / CC2510 available from Texas Instruments of Dallas, Texas and the dispensing unit processor can be the ARM7 provided by STMicroelectronics of Geneva, Switzerland. The software can be developed in a suitable programming language such as for example C or C++ or Assembler. Timer and sampling routines can use Assembler. The software can include one or more mechanisms for preventing variables from being corrupted due to simultaneous changes. The dispensing unit 102 as a whole and/or the reusable part 106 can be designed in one variation for static memory allocation.
These computer programs (also known as programs, software, software applications, applications; components, or code) can include machine instructions for a programmable processor, and can be implemented in a high-level procedural and/or object-oriented programming language, and/or in assembly/machine language. As used herein, the terms "machine-readable medium" and "computer-readable medium" refer to any computer program product, apparatus and/or device (e.g., magnetic discs, optical disks, memory, Programmable Logic Devices (PLDs)) used to provide machine instructions and/or data to a programmable processor, including a machine-readable medium that receives machine instructions as a machine-readable signal. The term "machine-readable signal" refers to any signal used to provide machine instructions and/or data to a programmable processor.
a dispensing unit and a command means capable to communicate therebetween,
a group of electronic components consisting of at least a controller and a transceiver,
wherein said controller is adapted for controlling operation of the dispensing unit,
wherein said command means is provided with an interface for inputting commands,
said dispensing unit and said command means are adapted to communicate therebetween so as to establish pairing, wherein said dispensing unit is adapted:
to initiate sending a communication message from the dispensing unit at a beginning of a current communication cycle,
to activate the transceiver for a limited period of a time,
to handle an incoming message if it is received from the paired command means; and
to wait for a next communication cycle so as to send a next communication message to the command means.
a dispensing unit and a command means capable to communicate therebetween, a group of electronic components consisting of at least a controller and a transceiver,
said dispensing unit and said command means are adapted to communicate therebetween so as to establish pairing, wherein said command means is adapted:
to receive a communication initiation input from a user,
to wait for receipt of a status message from the paired dispensing unit,
to handle the status message, and
to wait for receipt of a next status message from the paired dispensing unit if communication has not ended.
The fluid delivery device of any of claims 1-2, wherein the command means is adapted to handle logbook entries included in the status message.
The fluid delivery device of any of claims 1-3, wherein said dispensing unit is adapted for sensing and monitoring concentration levels of an analyte.
A method for communicating between a dispensing unit of a fluid delivery device and a paired command means, comprising:
The method of claims 5, further comprising suspending communication from the dispensing unit if the incoming message received from the paired command means is a stop communication message or if no message is received from the paired command means for greater than a threshold number of communication cycles.
The method of any of claims 5-6, further comprising sending a communication message from the dispensing unit on a next communication cycle after the current communication cycle ends.
A fluid delivery device comprising a dispensing unit comprising a controller that is capable to execute software instructions that implement the method of any of claims 5-7.
A method for communicating between a command means and a paired dispensing unit of a fluid delivery device, comprising:
The method of claim 9, wherein the handling status data comprises retrieving new logbook entries included in the status message received from the dispensing unit.
The method of any of claims 9-10, further comprising sending one or more new messages to the paired dispensing unit or sending a stop communication message and ending communication if no messages need to be sent.
The method of any of claims 9-11, further comprising incrementing a count of failed communication cycles since a last successful receipt of an incoming message if no status message is received from the dispensing unit and ending communication if the count exceeds a threshold.
The method of claim 5 or any one of claims 9-12, wherein the command means comprises a remote control unit or a personal or laptop computer or handheld communication device.
A fluid delivery device comprising a command means that is capable to execute software instructions that implement the method of any of claims 9-12 or claim 13 when dependent thereto.
A fluid delivery device according to any one of claims 1-4, 8 and 14, wherein the dispensing unit comprises a reusable part and a disposable part that is detachably connectable to the reusable part..
EP20110166335 2006-07-07 2007-07-06 Fluid delivery device and methods of its operation Pending EP2365452A3 (en)
EP20070866615 EP2044544B1 (en) 2006-07-07 2007-07-06 Fluid delivery device and methods of its operation
EP20070866615 Division-Into EP2044544B1 (en) 2006-07-07 2007-07-06 Fluid delivery device and methods of its operation
EP20070866615 Division EP2044544B1 (en) 2006-07-07 2007-07-06 Fluid delivery device and methods of its operation
EP2365452A2 true true EP2365452A2 (en) 2011-09-14
EP2365452A3 true EP2365452A3 (en) 2015-01-28
EP20110166350 Pending EP2365453A3 (en) 2006-07-07 2007-07-06 Fluid delivery device and methods of its operation
EP20070866615 Active EP2044544B1 (en) 2006-07-07 2007-07-06 Fluid delivery device and methods of its operation
EP20110166335 Pending EP2365452A3 (en) 2006-07-07 2007-07-06 Fluid delivery device and methods of its operation
WO (1) WO2008053368A3 (en)
WO2008053368A3 (en) 2008-12-24 application
EP2365453A3 (en) 2014-09-10 application
ES2670420T3 (en) 2018-05-30 grant
EP2044544B1 (en) 2018-04-18 grant
EP2044544A2 (en) 2009-04-08 application
EP2365452A3 (en) 2015-01-28 application
EP2365453A2 (en) 2011-09-14 application
WO2008053368A2 (en) 2008-05-08 application
DK2044544T3 (en) 2018-05-22 grant