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1. 1000 may also send wireless information back to the remote control device 1000 The information can include diagnostic information history information equipment status information alarm status information or other information related to the function of the device 1000 Information can also include device specific information such as serial number model number or a unique identifying alphanu meric code Information can also include confirmation that a previously downloaded transmission from the remote control device 100 was properly received or even improp erly received thereby triggering the remote control device 100 to repeat the previous transmission of electronic data Each transmission of electronic data between the device 100 and the apparatus 1000 can include an identification 10 15 20 25 30 40 45 50 55 60 65 6 representing the remote control device 100 the medical treatment apparatus 1000 or both The unique identifications which can include codes are placed in the electronic memory of either the remote control device 100 or the medical treatment apparatus 1000 during their manufac turing process After an initial communication between the device 100 and the apparatus 1000 either or both of the unique identifications can be transferred between the device and the apparatus and all subsequent communications can include either or both of the unique identifications In addition prior to act
2. According to an addi tional exemplary aspect the multi function medical appa ratus remote control device adapted for simultaneously or serial use with multiple medical treatment apparatus such as successive disposable infusion pumps Also provided as an aspect of the present invention are methods for assuring proper communication between a remote control device a specifie device to be controlled These aspects of the invention together with additional features and advantages thereof may best be understood by reference to the following detailed descriptions and examples taken in connection with the accompanying illus trated drawings BRIEF DESCRIPTION OF THE DRAWINGS FIG 1 is a perspective view of an exemplary embodiment of a remote control device constructed in accordance with the present invention FIG la is a perspective view of an exemplary embodi ment of a medical treatment apparatus constructed in accor dance with the present invention FIG 2 is a perspective view of another exemplary embodiment of a remote control device constructed in accordance with the present invention 10 15 20 25 30 35 40 45 50 55 60 65 4 FIG 2a is a section view of the remote control device of FIG 2 taken along line a a of FIG 2 FIG 2b is a perspective of an exemplary embodiment of ambulatory infusion device constructed in accordance with the present invention FIG 3 is a sectional side view of ano
3. 2000 wo W0Q01 52727 1 2001 WO W0Q01 76684 10 2001 WO WO 02 20073 3 2002 WO WO02 26282 4 2002 OTHER PUBLICATIONS US 5 954 699 9 1999 Jost et al withdrawn Web Site Brochure dated Jan 4 2000 MiniMed 508 Doing its job Naturally www minimed com tiles mm 113 htm Primary Examiner Timothy Edwards Jr 74 Attorney Agent or Firm McDermott Will amp Emery LLP 57 ABSTRACT A system for providing medical treatment to a patient including a medical treatment apparatus and a remote con trol device The medical treatment apparatus has a local processor and a local communication element connected to the local processor while the remote control device includes a remote processor user interface components connected to the remote processor and a remote communication element connected to the remote processor and adapted to commu nicate with the local communication element of the medical treatment apparatus in a wireless manner such that informa tion can be transferred between the local processor and the remote processor The remote control device also includes at least two separate power supplies connected to the remote Processor 67 Claims 7 Drawing Sheets US 6 768 425 B2 Page 2 4 108 177 4 151 845 4 193 397 4 211 998 4 231 019 4 268 150 4 364 385 4 373 527 4 424 720 4 435 173 4 469 481 4 475 901 4 498 843 4 507 115 4 514 732 4 529 401 4 551 134 4 559 033 4 559 037 4 560 9
4. allow a user to control separate electronic equipment without having to be in proximity to or otherwise have access to the controls of the separate electronic equipment Various medical apparatus can be controlled with a remote control device as well Examples of these devices include x ray machines operating tables diagnostic monitors and drug infusion devices The medical apparatus remote control devices provide similar advantages to tele vision or VCR remote control devices obviating the need for a user to be proximal to or have access to the controls of the medical apparatus As handheld electronic devices and remote control devices have become widespread in their use it has become desirable to combine multiple products or functions into single devices Such devices having multiple functions do exist but usually the particular grouping of functions are related such as the universal remotes available for televisions VCRs and other home audiovisual equipment remote control devices In U S Pat No 4 855 746 for example Stacy shows a multi device remote control with an array of keys that are exposed in pre selected groups by 10 15 20 35 40 45 50 55 60 65 2 moving a slidable cover A position of the slidable cover determines which device the remote control device will control and the type of coded control signals that the remote control device will transmit Other examples of devices having mu
5. by DuPont Corporation of Wilmington Del The assembly lid 352 may include an adhesive on its bottom surface to facilitate sealed attachment to the assembly tray 353 The sealed tray construction allows the fluid delivery device 10 to be sterilized utilizing various methods includ ing ethylene oxide sterilization In one possible embodiment the fluid delivery device 10 of the packaged assembly 350 can include an integral transcutaneous infu sion set At least the transcutaneous infusion set and fluid path portions of the device 10 are sterilized to prevent contaminants from passing through the skin of a patient using the device 10 Also shown in FIG 6 the fluid delivery device 10 is provided with an information barcode 26 Such an informa tion barcode 26 may be utilized by various systems for cataloging or otherwise recording information about the fluid delivery device 10 The remote control device 100 of FIG 6a can be provided with a bar code reader function and can be programmed to upload the information barcode 26 data to perform an initialization function described here above The information barcode 26 data can be unique for each fluid delivery device 10 and include a unique fluid delivery device identification or other unique and non US 6 768 425 B2 15 unique information such as manufacturing date serial number type of medication preloaded concentration of medication physician identification patient identification o
6. can be brought on line and or particular functions made no longer available or deactivated to insure continued operation of the medical apparatus apparatus control function In addition to discreet energy level measurements such as voltage level measurements a history of activity potentially including current measurements history of battery replace ments and measurements and other multiple information 10 15 20 25 30 35 40 45 50 55 60 65 14 data analysis can be used integrated or otherwise analyzed to determine which functions to enable and disable or how to distribute power among the functions Another exemplary embodiment of a remote control device 100 of the present invention is shown in FIGS 5 and 5a The device of FIGS 5 and 5a is similar to the device of FIGS 2 and 2a such that similar elements have the same reference numerals The device of FIGS 5 and 5a however includes a touch screen display 110TS for allowing user input as well as for displaying information Also included in the remote control device 100 of FIGS 5 and 5a is an electronic communication port 171 The port 171 can be a simple modem for connection to an outside computer or internet system via a phone line or an Ethernet connector for connection to a network the internet or other wired electronic communication channel The communica tion port 171 can facilitate other forms of electronic infor mation upload o
7. comprises a capacitor 18 A system according to claim 14 wherein the dedicated power supply is unitarily integrated as part of the remote control device 19 A system according to claim 14 wherein the remote processor is programmed to use the dedicated power supply upon a measured power level of the general purpose power supply falling below a predetermined minimum power level US 6 768 425 B2 21 20 A system according to claim 1 wherein the medical treatment apparatus comprises a fluid delivery device also including an exit port assembly and a dispenser for causing fluid from a reservoir to flow to the exit port assembly wherein the local processor is connected to the dispenser and is programmed to cause fluid flow to the exit port assembly based upon flow instructions 21 Asystem according to claim 20 wherein the exit port assembly of the fluid delivery device includes a transcuta neous access tool 22 A system according to claim 20 wherein the local processor is programmed to cause fluid flow to the exit port assembly only upon receiving the flow instructions from the remote control device 23 A system according to claim 20 wherein the fluid delivery device is packaged in a container for shipping and handling prior to use 24 A system according to claim 20 wherein the local processor of the fluid delivery device is pro grammed to cause a flow of fluid to the exit port assembly based solely on flow instru
8. not shown Alternatively fluid delivery device 10 may be prefilled with the liquid medication obviating the need for therapeutic fluid supply 250 Various ways of combining devices of the present inven tion into appropriate infusion kits can include packaging multiple units of one type of device with a single other type of device For example a single remote control device 100 of the present invention can be provided as a kit with thirty to one hundred low cost disposable fluid delivery devices 10 of the present invention Typical kit configurations include a single remote control device 100 packaged with multiple delivery device packaged assemblies 350 each containing fluid delivery device 10 If the fluid delivery device 10 is not filled with liquid medication therapeutic fluid supply 250 are also packaged in the infusion kit In addition to the above components or products other components or products may be packaged in the infusion kit such as user instructions batteries for the remote control device 100 multiple batter ies for the fluid delivery devices 10 syringes needles transcutaneous penetration site preparation materials and other peripheral devices In addition blood glucose measur ing supplies such as finger prick devices test strips diag nostic devices such as glucometers and other blood glucose measurement accessory devices may be supplied in the kit One or more backup remote control devices 100 can also be include
9. of an electronic game a barcode reader a television or VCR remote or a cellular telephone for example Many other functions are possible FIGS 2 and 2a show another possible embodiment of a remote control device 100 according to the present inven tion The remote control device is similar to the remote control device of FIG 1 such that similar elements have the same reference numerals Internal components of the remote control device 100 are contained within a housing 102 and include a communication element 160 referred to in appended claims as remote communication element which is used to send wireless communication to the medi cal treatment apparatus 1000 The wireless communication may consist of electronic packets of information sent by radio frequency infrared ultrasound or other wireless forms of communication Also included is a power supply 108 which can be integral to the device and rechargeable by attaching to a standard AC power converter Alternatively the power supply 108 may consist of standard battery technology such as nickel cadmium alkaline silver oxide or other batteries available at convenience and other stores and be replaceable Within the housing 102 is an electronic printed circuit board 101 having electronics 105 that includes memory 107 which is shown as a separate electronic module but prefer ably is integral with the electronics 205 The electronics 105 also includes a microprocessor or other pr
10. or through the skin of a patient into the subcutaneous tissue or other transcutaneously accessed site such as a vein or artery intended for the fluid delivery Alternatively exiting the housing 20 may be a standard Luer attachment such that a connection to a stan dard transcutaneous infusion set can be made Preferably the fluid delivery device 10 is designed to be low cost and have limited life such as 2 to 3 days and thereafter be disposable Such an inexpensive disposable device is possible because the device 10 does not have an US 6 768 425 B2 9 expensive complex user interface such as electromechanical switches and visual displays since user interface is accom plished via the remote control device 100 The fluid delivery device 10 may be filled with insulin and associated programming of fluid delivery device 10 and remote control device 100 sufficient to allow the sophisti cated flow profiling and bolus requirements for a diabetic patient such as insulin dependent or Type I diabetics This patient population are required to take repeated doses of insulin just to survive and the advantages of continuous infusion of insulin has been well demonstrated in scientific studies In the case where the remotely controlled medical treat ment apparatus is a mass produced product such as the disposable infusion pump 10 described above the remote control device 100 may communicate with numerous infu sion pumps 10 over a period o
11. used Also various methods of creating and storing electronic unique identifying codes have been described however other means of coding transmissions to create unique identifications that can be uploaded and downloaded to accomplish confirmed communication between the remote control device 100 and medical treatment apparatus 1000 may be employed Also the fluid delivery device of this invention is intended to be low cost light weight simple to use and potentially disposable by removing a majority of the user interface including electromechanical switches from the fluid delivery device and including a separate remote con trol device to replace those functions A reservoir fluid dispenser transcutaneous fluid administration means solid state electronics and wireless communications are included in the fluid delivery device to perform its intended function While various means of reservoir construction pressuriza tion means fluid pumping means fluid metering means transcutaneous delivery electronic control and wireless communications have been discussed in this application alternatives to each of these areas can be made without departing from the spirit of the invention In addition where this patent application has listed the steps of a method or procedure in a specific order it may be possible or even expedient in certain circumstances to change the order in which some steps are performed and it is intended that the particul
12. 0 can be combined with a separate metering element to achieve the proper volume of fluid to be infused or the dispenser 40 can be adapted to independently infuse the correct volumes If the reservoir 30 is pressurized by a compressing member or by being enclosed in a gas pressurized chamber for example the dispenser 40 can be adapted to simply meter the fluid from the reservoir The dispenser 40 can then include an accumulator chamber and valves before and after the accumulator chamber to dispense fixed pulses of fluid Alternatively the dispenser 40 can be adapted to control flow rate via orifice constriction and expansion Still referring to FIG 3a an electronic microcontroller 50 referred to in the appended claims as a local processor is used to electronically control the dispenser 40 The dis penser 40 can include electrically driven propulsion means electrically activated remote control devices such as piezo valves or solenoid actuators motors or micro motors or other electromechanical components requiring electrical sig nals for activation power or both Powering the dispenser 40 and the electronic microcontroller 50 is a power supply 80 which is preferably a battery If the fluid delivery device 10 is a low cost disposable advice the power supply 80 is preferably integral to the fluid delivery device 10 to thereby avoid the need for a user to purchase and insert batteries The fluid delivery device 10 of FIG 3a is co
13. 100 of FIG 1 so that a user can adjust various parameters request information or otherwise command control or communi cate with the medical treatment apparatus 1000 In this embodiment the parameters to be adjusted can include selection of a particular EKG lead to be displayed adjust ment of the display scale or other parameters of the device 1000 for example This remote control capability may be of great advantage when the device 1000 is close to an active x ray contained in the sterile field of a medical procedure or contained in other biologically hazardous fields for example The medical treatment apparatus 1000 includes internal electronics not shown to take the information received via the antenna 1030 interpret the data in electronic form and adjust programming or other parameters accordingly The remotely controllable apparatus 1000 can comprise medical devices and or perform functions other than electrocardio gram monitoring such as an external infusion pump an implanted infusion pump a pacemaker an cardiac defibrillator an neurostimulator an X ray machine an EKG machine blood sampling blood analysis a diagnostic device a glucometer blood analyzing equipment an elec trocautery device an operating room table a visual monitor a laparoscopic device and other medical equipment and functions In addition to receiving electronic wireless communica tion via the antenna 1030 the medical treatment apparatus
14. 36 wherein the power supply comprises a battery 38 A system according to claim 36 wherein the power supply is user replaceable 39 A system according to claim 36 wherein the remote processor is programmed to ignore hysteresis in the mea sured power level 40 A system according to claim 36 wherein the medical treatment apparatus includes a unique identification included in all communications between the medical treat ment apparatus and the remote control device 41 A system according to claim 36 wherein the remote control device includes a unique identification included in all communications between the medical treatment appara tus and the remote control device 42 A system according to claim 36 wherein the medical treatment apparatus comprises one of an external infusion pump an implanted infusion pump a pacemaker a cardiac defibrillator a neurostimulator an x ray machine an EKG US 6 768 425 B2 23 machine a diagnostic device a glucometer a blood analyzer an electrocautery device an operating room table a monitor and a laparoscopic controller 43 A system according to claim 36 wherein the remote control device is also adapted to function as at least one of a cellular phone a personal digital assistant and an elec tronic game 44 A system according to claim 36 wherein the remote control device further includes electronic memory storing a user manual for the medical treatment apparatus 45 A system
15. 6 wherein the fluid delivery device includes a housing containing the exit port assembly the dispenser the local processor and the local communication unit and wherein the housing is free of user output components for providing the flow information from the local processor to a user 28 A system according to claim 26 wherein the local processor is programmed to receive at least some of the flow instructions from the remote control unit the local communication unit also includes a wireless receiver connected to the local processor the remote communication unit of the remote control device includes a remote transmitter for sending the flow instructions to the local receiver and 10 15 20 25 30 35 40 45 50 55 60 65 22 the user interface components of the remote control device include input components connected to the remote processor for allowing a user to enter the flow instructions 29 A kit including a system according to claim 20 and further comprising a subcutaneous access tool for connec tion to the exit port assembly of the fluid delivery device 30 A kit according to claim 29 including one of the remote control device a plurality of the fluid delivery devices and a plurality of subcutaneous access tools for connection to the exit ports of the fluid delivery device 31 A kit according to claim 30 wherein each fluid delivery device includes a bar code 32 A system according t
16. 74 300 6 190 359 6 206 850 6 375 638 6 520 936 6 527 744 6 554 798 PP gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt U PP gt gt gt gt gt gt gt gt gt gt gt gt IP PP PP PP PP PP PP PP P PP PP PP gt gt gt B1 B1 2 1996 4 1996 4 1996 5 1996 7 1996 8 1996 9 1996 11 1996 11 1996 12 1996 5 1997 6 1997 7 1997 7 1997 8 1997 9 1997 9 1997 12 1997 12 1997 1 1998 3 1998 3 1998 4 1998 5 1998 5 1998 7 1998 7 1998 7 1998 7 1998 8 1998 9 1998 9 1998 9 1998 9 1998 11 1998 11 1998 12 1998 12 1998 12 1998 1 1999 2 1999 2 1999 3 1999 4 1999 4 1999 5 1999 6 1999 7 1999 8 1999 8 1999 9 1999 9 1999 10 1999 10 1999 11 1999 11 1999 12 1999 2 2000 2 2000 5 2000 6 2000 11 2000 11 2000 1 2001 1 2001 2 2001 3 2001 4 2002 2 2003 3 2003 4 2003 Athayde et al Funderburk et al B cker et al Hiejima Kamen et al Funderburk et al Lattin et al 604 20 Melsky et al Deleeuw Livingston et al Tune et al Nason et al McPhee Feldmann et al Saaski et al Colman et al McPhee Flaherty et al Flaherty Gross Brody Altendorf et al Lambrecht et al Holl et al Knudson et al Kriesel et al Kriesel et al Indravudh Joshi et al Gadot Wilson McPhee Flaherty Gross Saaski et al Flaherty Altschul Gross et al Marano et al Kriesel Falk et al Altschul et al Badger et al Saito et al Jackson McPhee Rake et
17. 79 4 562 751 4 585 439 4 601 707 4 624 661 4 634 427 4 678 408 4 684 368 4 685 903 4 755 173 4 781 688 4 781 693 4 801 957 4 808 161 4 836 752 D303 013 4 855 746 4 871 351 4 882 600 4 886 499 4 898 579 D306 691 4 944 659 D311 735 4 969 874 4 973 998 D315 727 5 007 458 5 045 871 5 062 841 5 109 850 5 176 662 5 178 609 5 205 819 5 213 483 5 232 439 5 239 326 5 242 406 5 244 463 5 254 096 5 257 980 5 281 202 5 308 335 5 312 337 5 318 540 5 342 313 5 346 476 5 364 342 5 411 480 5 433 710 5 452 033 U S PATENT DOCUMENTS 8 1978 5 1979 3 1980 7 1980 10 1980 5 1981 12 1982 2 1983 1 1984 3 1984 9 1984 10 1984 2 1985 3 1985 4 1985 7 1985 11 1985 12 1985 12 1985 12 1985 1 1986 4 1986 7 1986 11 1986 1 1987 7 1987 8 1987 8 1987 7 1988 11 1988 11 1988 1 1989 2 1989 6 1989 8 1989 8 1989 10 1989 11 1989 12 1989 2 1990 3 1990 7 1990 10 1990 11 1990 11 1990 3 1991 4 1991 9 1991 11 1991 5 1992 1 1993 1 1993 4 1993 5 1993 8 1993 8 1993 9 1993 9 1993 10 1993 11 1993 1 1994 5 1994 5 1994 6 1994 8 1994 9 1994 11 1994 5 1995 7 1995 9 1995 Pistor Clemens Tucker et al Junginger et al Junginger et al Chen Lossef Fischell Bucchianeri Siposs et al Kobayashi Kraegen et al Schneider et al Kambara et al Hayes Jr Leslie et al Slavik et al Stephen et al Franetzki et al Rosskopf Nason et al Michel Albisser et al Arimond Hannula et al Nason et
18. a United States Patent Flaherty et al US006768425B2 US 6 768 425 B2 Jul 27 2004 10 Patent No 45 Date of Patent 54 MEDICAL APPARATUS REMOTE CONTROL AND METHOD 75 Inventors J Christopher Flaherty Topsfield MA US John T Garibotto Charlestown MA US 73 Assignee Insulet Corporation Beverly MA US Notice Subject to any disclaimer the term of this patent is extended or adjusted under 35 U S C 154 b by 414 days 21 Appl No 10 032 167 22 Filed Dec 21 2001 65 Prior Publication Data US 2002 0126036 A1 Sep 12 2002 Related U S Application Data 60 Provisional application No 60 257 756 filed on Dec 21 2000 51 MRC 2 2 a H04Q 9 00 52 US Cl vee 340 870 07 128 920 604 132 604 890 1 604 892 1 58 Field of Search 340 870 07 600 300 128 903 820 604 65 67 95 01 132 890 1 892 1 56 References Cited U S PATENT DOCUMENTS 3 631 847 A 1 1972 Hobbs 3 812 843 A 5 1974 Wootten et al 4 067 000 A 1 1978 Carlson List continued on next page FOREIGN PATENT DOCUMENTS DE 4200595 7 1993 DE 19920896 9 2000 EP 0342947 5 1989 EP 0763369 3 1997 EP 0867196 3 1998 EP 0937475 8 1999 WO WO81 01658 6 1981 WO WO86 06796 11 1986 WO WO98 01071 1 1998 WO WO99 10040 3 1999 WO WO00 19887 9 1999 wo WO99 62576 9 1999 WO WO00 29049 5 2000 wo W0Q00 74752 5 2000 WO W0Q00 30705 6 2000 WO W0Q00 78210 6 2000 WO W0Q00 48112 8 2000 WO WO00 61215 10
19. according to claim 36 wherein the wireless communication between the remote control device and the medical treatment apparatus is radio frequency signals 46 A system according to claim 36 wherein the remote control device further includes an alarm connected to the remote processor and the remote processor is programmed to activate the alarm upon the measured power level of the power supply falling below the predetermined minimum power level 47 A system according to claim 46 wherein the alarm comprises an audible alarm 48 A system according to claim 36 wherein the remote processor is programmed to receive a unique identification for the medical treatment apparatus during a first commu nication with the medical treatment apparatus 49 A system according to claim 48 wherein all subse quent communications between the medical treatment appa ratus and the remote control device include the unique identification for the medical treatment apparatus 50 A system according to claim 36 wherein the remote processor is programmed to send a unique identification for the remote control device during a first communication with the medical treatment apparatus 51 A system according to claim 50 wherein all subse quent communications between the medical treatment appa ratus and the remote control device includes the unique identification for the remote control device 52 A system according to claim 36 wherein the medical treatment apparat
20. al Kenyon Cable et al Konopka et al Thoma et al Martinez et al Vandemoere Kamen Burkett Konopka Stacy Feingold Van de Moere Cirelli et al Groshong et al Arai Labbe et al Aran et al Michel et al Gates Arai et al Marcus et al Reinholdson Siegel Blanco et al Ishikawa Ross et al Flaherty et al Campbell et al Takai Gross et al Cordner Jr et al Rondelet et al Weber et al Ross et al Flaherty et al Athayde et al Campbell et al Elson Beuchat et al Kriesel PPP gt P gt PP gt P gt PP gt P gt P gt PP gt P gt PP gt P gt P gt PP gt P gt PP gt ApPP gt ApPAPPPPP gt APPPPP gt PPPPPP gt PPPPPP gt P gt PPPP gt PPP gt PPP gt PPP gt P gt Balling et al Bartholomew et al Van Antwerp et al Van Antwerp et al 5 492 534 5 505 709 5 507 288 5 514 096 5 533 389 5 545 152 5 551 953 5 575 770 5 576 781 5 584 813 5 630 710 5 637 095 5 643 213 5 647 853 5 660 728 5 665 065 5 665 070 5 695 490 5 702 363 5 704 520 5 726 404 5 726 751 5 741 228 5 748 827 5 755 682 5 776 103 5 779 676 5 785 681 5 785 688 5 797 881 5 800 397 5 800 405 5 810 015 5 814 020 5 839 467 5 840 063 5 845 218 5 848 991 5 851 197 5 858 005 D405 524 5 875 393 5 886 647 5 891 097 5 897 530 5 906 597 5 911 716 5 919 167 5 931 814 5 935 099 5 954 058 5 957 890 5 961 492 5 965 848 5 983 094 5 993 423 5 997 501 6 019 747 6 024 539 6 061 580 6 071 292 6 144 847 6 152 898 6 171 264 6 1
21. al Mulhauser et al Alex et al Peterson et al Flaherty Mann et al Kriesel et al Altschul et al Altschul et al Choi Gross et al McPhee Blomquist Altschul et al Makower et al Altschul et al Olsen Bader 0 20 600 595 Kriesel et al Heruth O Neil Nason et al Mann Kriesel et al Mann et al 604 131 US 6 768 425 B2 Page 3 6 558 320 B1 5 2003 Causey et al 600 300 6 645 142 B2 11 2003 Braig et al 600 300 OTHER PUBLICATIONS Web Site Brochure dated Dec 20 1999 Applied Medical Technology 508 Pump Information www applied medi cal co uk 508 htm Web Site Brochure dated Jan 4 2000 The Glucose Sen sor www animascorp com sensor f html Web Site Brochure dated Dec 20 1999 The Animas R 1000 Insulin Pump www animascorp com pump f _ s html Web Site Brochure dated Dec 20 1999 The Animas R 1000 Insulin Pump www animascorp com pump f _ f html Web Site Brochure dated Jan 4 2000 SOOIL Homepage Portable Insulin Pump www sooil com intro2 htm Web Site Brochure dated Jan 4 2000 SOOIL Homepage Portable Insulin Pump www sooil com product2 htm Web Site Brochure dated Jan 4 2000 SOOIL Homepage Portable Insulin Pump www sooil com product3 htm Web Site Brochure dated Jan 4 2000 SOOIL Homepage Portable Insulin Pump www sooil com product4 htm Copy of International Search Report c
22. an be prompted by a user or the remote control device 100 and the fluid delivery device 10 can be programmed to automatically exchange identifications upon initial communications FIG 3 depicts a cross sectional side view of another possible embodiment of a remote control device 100 of the present invention The remote control device is similar to the remote control device of FIG 2 such that similar elements have the same reference numerals The remote control device 100 of FIG 3 however further includes multiple power supplies to prevent inadvertent power outage for portions of the device 100 relating to control of a medical treatment apparatus Removable from the housing 102 is a battery door 111 which allows access to first power supply 108A and second power supply 108B which can comprise replaceable bat teries Preferably at least one of the first power supply 108A and the second power supply 108B is always used to power each function of the remote control device 100 When the energy remaining in the first power supply 108A referred to in the appended claims as general purpose power supply decreases to a certain predetermined level or other means of determining remaining energy life the second power supply 108B referred to in the appended claims as dedicated 10 15 25 35 40 45 50 55 60 65 10 power supply is utilized for power The first power supply 108A can continue to be depleted or
23. ansmitter Various methods of using remote control device 100 are included in the present invention and described above The method of programming the fluid delivery device 10 with remote programmer 100 as well as control of other forms of medical treatment apparatus 1000 are described Also rel evant is the ability to update the internal programming of either the fluid delivery device 10 or the remote control device 100 by the corresponding device Methods of creat ing and mapping unique alphanumeric identifications for a medical treatment apparatus such as the fluid delivery device 10 of the present invention and the remote control device 100 have been described While the majority of description for a medical treatment apparatus have regarded a fluid delivery device 10 many other types of medical apparatuses are applicable for use with a remote control device of the present invention 100 The value of the multi function remote control 100 is enhanced in situations where the user is more likely to carry the remote control device in their daily routine or as part of their job This condition is obvious with the diabetic patient for continuous infusion of insulin but also found in patients and hospital workers who need to control medical treatment apparatus for a long portion of their day potentially their working day The advantage of other multiple uses makes the requirement of carrying and otherwise maintaining the remote control device
24. ar steps of the method or proce dure claims set forth herebelow not be construed as being order specific unless such order specificity is expressly stated in the claim What is claimed is 1 A system for providing medical treatment to a patient comprising A a medical treatment apparatus including a local processor and a local communication element connected to the local processor B a remote control device separate from the medical treatment apparatus and including a remote processor user interface components connected to the remote processor a remote communication element connected to the remote processor and adapted to communicate with the local communication element of the medical treatment apparatus in a wireless manner such that information can be transferred between the local processor and the remote processor and at least two separate power supplies connected to the remote processor wherein the separate power sup plies include a general purpose power supply and a dedicated power supply and the remote control device is adapted to use the dedicated power supply only for a subset of the functions of the remote 10 15 20 25 30 35 40 45 50 55 60 65 20 2 A system according to claim 1 wherein the medical treatment apparatus includes a unique identification included in all communications between the medical treat ment apparatus and the remote control device 3 A system accordi
25. ay wish to place the device beneath their clothing for added comfort and or for privacy a remote control device is appropriate to adjust various parameters associated with the infusion pump or simply to review pump status or other pump information These patients may also carry a glucose mea suring device such as a glucometer as well as a cellular phone pager PDA or other handheld electronic device not directly associates with the treatment of their health condi tion Ambulating with multiple handheld devices such as these can be fraught with issues not the least of which is contusion and the increased probability of losing one of the devices Certain ambulatory infusion devices may be designed to be of limited life or even disposable For example U S patent application Ser No 09 943 992 filed on Aug 31 2001 which is assigned to the assignee of the present application and incorporated herein by reference discloses a remotely controlled disposable infusion pump In such cases it would be desirable to provided a non disposable remote control device that can be used to control successive disposable pumps If a handheld electronic device is to be used for control ling a medical apparatus such as an infusion pump certain prioritization of performance may be desired One such prioritization for example relates to power consumption As most of today s handheld devices are powered by a replaceable or rechargeable battery it may b
26. be of such importance that continued use of the phone function at the risk of deactivation of the medical control function due to depletion of the single power supply 108 may be acceptable In such an embodiment the remote control device 100 might require the user to override the deactivation by confirmation via the keyboard 120 or other user input means of the device 100 to reactivate the phone function The override may be temporary or permanent and may trigger a second level of remaining energy level thresholds e g VT2 to be employed for the deactivation of the phone function when the available power of the single power supply 108 decreases below the second voltage threshold VT2 The remote control device 100 may include means of alerting the user prior to deactivation of any functions This alert may be accomplished with audio or visual information made available to the user by detection of particular energy states of the one or more power supplies For example a voltage threshold just above the first voltage threshold VT1 may cause the alert condition to occur thus notifying the user that certain functions are near deactivation similar to a low battery warning condition found in many battery pow ered devices In addition multiple thresholds can be detect able by the electronics of the remote control device 100 such that one or more low battery conditions as they relate to individual or groups of specific functions can be used to s
27. ble alarm 10 A system according to claim 1 wherein the remote processor is programmed to receive a unique identification for the medical treatment apparatus during a first commu nication with the medical treatment apparatus 11 A system according to claim 10 wherein all subse quent communications between the medical treatment appa ratus and the remote control device include the unique identification for the medical treatment apparatus 12 A system according to claim 1 wherein the remote processor is programmed to send a unique identification for the remote control device during a first communication with the medical treatment apparatus 13 A system according to claim 12 wherein all subse quent communications between the medical treatment appa ratus and the remote control device includes the unique identification for the remote control device 14 A system according to claim 1 wherein the separate power supplies include a general purpose power supply and a dedicated power supply and the remote control device is adapted to use the dedicated power supply only for functions related to communications between the medical treatment apparatus and the remote control device 15 A system according to claim 14 wherein the general purpose power supply comprises a battery 16 A system according to claim 14 wherein the general purpose power supply is user replaceable 17 Asystem according to claim 14 wherein the dedicated power supply
28. check would be performed to confirm completion and accuracy of the message using checksum or other techniques known to those of skill in the art as well as a check that the proper fluid delivery device 10 had sent the information to the proper remote control device 100 After acceptable confirmations a return signal may be sent to acknowledge acceptance and then appropriate actions would take place in the remote control device 100 In a preferred embodiment the fluid delivery device 10 is an insulin delivery device for diabetic patients The fluid delivery device is disposable used by the patient for three or less days and requires the remote control device 100 for programming and use It is imperative that proper commu nications are confirmed including confirmation that the proper remote control device 100 is commanding the proper fluid delivery device 10 These patients may be part of patient groups attend diabetes conferences or otherwise be in the presence of one or multiple patients who utilize the same system Protocols such as that disclosed in this appli cation are imperative to prevent undesired programming changes of any type In addition the remote control device 100 and or fluid delivery device 10 may include a proximity alarm or alarms such that when the distance between the remote control device 100 and fluid delivery device 10 exceeds a particular amount one or both devices produce an audible and or tactile such as vibra
29. ctions from the separate remote control device the local communication unit includes a wireless receiver for receiving the flow instructions and delivering the flow instructions to the local processor the remote communication unit of the remote control device includes a remote transmitter for sending the flow instructions to the local receiver and the user interface components of the remote control device include input components connected to the remote processor for allowing a user to enter the flow instructions 25 A system according to claim 24 wherein the fluid delivery device includes a housing containing the exit port assembly the dispenser the local processor and the wireless receiver and wherein the housing is free of user input components for providing the flow instructions to the local processor 26 A system according to claim 20 wherein the local processor of the fluid delivery device is pro grammed to provide flow information the local communication unit includes a wireless trans mitter for transmitting the flow information from the local processor the remote communication unit of the remote control device includes a remote receiver for receiving the flow information from the local transmitter and the user interface components of the remote control device include output components connected to the remote processor for allowing a user to receive the flow information 27 A system according to claim 2
30. d with the kit Many variations of kits are possible FIGS 7 7a and 7b depict diagrammatic views of an embodiment of a remote control device 100 communicating with an embodiment of a fluid delivery device 10 or the present invention FIG 7 depicts an initial communication between the remote control device 100 and the fluid delivery device 10 wherein the remote control device 100 sends a wireless electronic information signal to the fluid delivery device 10 The internal electronics of the fluid delivery device are programmed to detect an initial communication and from then on only accept communications that include information different than information contained in the initial communication The initial communication may 10 15 20 25 30 39 40 45 50 55 60 65 16 include codes that signify the initiation and subsequent communications may include codes that not only signify not being the initial communication but also include informa tion calculated uploaded downloaded or otherwise deter mined during or as a result of the initial communication In a preferred embodiment all fluid delivery device 10 internal programming by manufacturing is standardized or non unique to reduce manufacturing costs At the initial communication with the remote control device 100 a unique identification is transmitted to the fluid delivery device 10 received by the fluid delivery device 10 and stored in the memory of t
31. e communica tions would include a receiving antenna and electronics to US 6 768 425 B2 5 interpret and otherwise transform the communicated data to a useful form such as that described in subsequent figures and embodiments found herebelow FIG la depicts an example of a medical treatment apparatus 1000 of the present invention The example is a electrocardiogram device 1000 with multiple displays a first medical treatment apparatus display 1010A and a second medical treatment apparatus display 1010B The first display 1010A is shown with waveforms produced by various EKG leads attached to a patient s skin not shown that make up a typical electrocardiogram of a heart patient with an inferior myocardial infarction Other examples of medical treatment apparatus that can be remotely controlled include one or more of the following external infusion pump implanted infusion pump pacemaker cardiac defibrillator neurostimulator x ray machine EKG machine diagnostic device glucometer blood analyzing equipment electrocau tery devices operating room tables visual monitors and laparoscopic remote control devices The medical treatment apparatus includes a housing 1002 on which is mounted various controls including electrome chanical switches 1020 Also depicted in FIG la is an integrated antenna 1030 shown exposed but preferably contained within the device 1000 The antenna 1030 receives signals from the remote control device
32. e desirable to regulate power consumption and low battery conditions in a specialized manner In U S Pat No 4 514 732 for example Hayes shows power conservation methods for particular commands of a remote control for electronic audiovisual equipment When a user continually presses a key on the remote control such as to decrease volume the remote control is programmed to send a single command signal to the equipment to start decreasing volume when the user initially presses the button and to send a single command signal to stop decreasing volume when the button is US 6 768 425 B2 3 released Hayes method avoids sending a continuous stream of signals to dictate the volume decrease in the equipment thus reducing the power consumption of the remote control Some electronic handheld devices and remote controls include low battery warnings via an audible alert screen message or other visual low battery indicator Often these devices are used until the batteries contain insufficient energy to power the device at which time the batteries are replaced or recharged However for controlling medical treatment apparatus such down time due to lack of new batteries could be very undesirable Accordingly there continues to be a need for remote control devices which can be used with medical treatment apparatus such as disposable infusion pumps as well as other functions The additional functions may be related to the therapy or medical t
33. ed or a new action performed An alternative to the dual power supply construction presented in FIG 3 and discussed above includes the creation of two preset energy thresholds for use with the single power supply 108 illustrated in FIG 2a The remote control device 100 further includes means for measuring a threshold such as a first voltage threshold VT1 illustrated in FIG 4 When the energy level in the single power supply 108 decreases to below the first voltage threshold VT1 functions of the device 100 not related to the remote control of the medical treatment apparatus are deactivated or shut down For example a non medical function such as cellular telephone use may be of a de prioritized nature as compared to control of a medical treatment apparatus such as a fluid delivery device for the delivery of insulin to a diabetic patient Therefore the remote processor 105 is programmed to shut down the cellular telephone function of the remote US 6 768 425 B2 13 control device 100 when the available power of the single power supply 108 decreases below the first voltage threshold VTI in order to allow one or more hours of control of the fluid delivery device In addition a possible embodiment of the remote control device 100 can include an override function that allows continued use of the non medical control function s if desired by a user In cases of emergency for example the cellular phone function of the device 100 may
34. electively deactivate individual or groups of specific func tions in a prioritized manner For example a remote control device 100 that includes medical treatment apparatus control cellular telephone function and personal digital assistant function may include thresholds for all three stated functions and deactivate the PDA function first and then the cellular function prior to the medical treatment apparatus remote control device function It should be considered in the scope of this application that there are various techniques for determining the amount of energy remaining in one or more power supplies Voltage detection is common and the energy dissipation curves of batteries of various technologies can be predicted quite reliably Other techniques can be used in conjunction with or independent of voltage detection without departing from the spirit of this application Examples of one or two power supply embodiments have been described however three or more power supplies can be used to achieve similar outcomes and a single power supply may consist of more than one battery connected in series or in parallel or both In addition multiple energy thresholds can be measured in any or all of the power supplies to change the status of function availability In other words one or more batteries can be employed utilizing one or more remaining energy measurements preferably voltage thresholds Based on these thresholds additional power supplies
35. electronic device However if use of the non medical function depletes the battery to a low enough level to prevent control of the medical apparatus the multi function device may lose its appeal The power supply control circuitry described herein therefore prevents non medical usage of remote control device 100 that would deplete the batteries to a point of loss of the medical apparatus remote control function FIG 3a shows a fluid delivery 10 to be remotely con trolled by a remote control device 100 of the present invention The fluid delivery device of FIG 3a is similar to the fluid delivery device of FIG 2b The fluid delivery US 6 768 425 B2 11 device 10 includes recessed housing 200 which includes a recessed surface 29 positioned within a continuous ring adhesive layer 201 Located beneath housing adhesive layer 201 may be secondary housing adhesive layer 202 such that if the housing adhesive layer 201 loses sufficient adhesive properties and is removed the secondary adhesive layer 202 is available to attach or reattach the fluid delivery device 10 to skin of a patient Preferably the size of the fluid delivery device 10 is small to allow comfortable adhesive attachment to the patient s skin Based on the size and shape of recessed housing 200 it may be desirable for the outer shell to flex after adhesive attachment to the patient s skin Included at various locations along recessed housing 200 are housing hinged secti
36. es power to all functions of the device 100 and the second power supply 108B only supplies power to the medical apparatus controlling functions and becomes activated only when the first power supply 108A is depleted to a predetermined level Each power supply 108A 108B can be a battery or other energy storage means such as a capacitor can be user replaceable or can be integral to the device and rechargeable with standard recharging means In one possible embodiment the second power supply is provided as a capacitor or battery that is not user replaceable is enclosed within the housing 102 and is not accessible via removal of a battery door In any event the dual power supply configuration allows the remote control device 100 to prioritize providing power to support the remote control of a medical apparatus versus other user supportive functions such as a cellular phone function Since it may be greatly preferred to allow down time with the cellular function versus any down time with the control of the medical treatment apparatus the dual power supply control functions described herein avoid a user inadvertently or accidentally depleting a battery supply using a function such as a phone call and then being unable to control their medical apparatus It is a great advantage for the user to be able to combine a remote control of a medical apparatus with other functions such as cellular phones personal digital assistant or other handheld
37. f the remote control device 100 itself The computer port 170 can include integrated wireless communication technologies to connect to a separate computer or computer network without the need for wires or mechanical connection means Referring to FIG 2b the fluid delivery device 10 is designed to be small and lightweight and includes a housing 20 and an adhesive attachment means not shown secured to an external bottom surface of the housing for attaching the device to the skin of a patient Internal to the fluid delivery device 10 are a reservoir for storing the liquid medicament a fluid dispenser for controlled fluid delivery a communi cation element for receiving the wireless communications from the remote control device 100 and electronics for receiving the electronic communication and controlling the function of the device On the outer surface of the housing 20 is included a needle insertion septum 32 to allow fluid to be placed into the reservoir of the fluid delivery device 10 via a syringe Alternatively the fluid delivery device 10 may be prefilled with the liquid medication at a manufacturing site prior to the device 10 being distributed to the patient or caregiver simplifying setup and reducing cost by eliminat ing patient filling and obviating the need for needle insertion septum 32 Exiting the housing 20 is the outlet of the fluid path of the device including skin penetrating cannula 72 which is inserted transcutaneously
38. f time For each new infusion pump 10 placed into operation by a user a unique identifi cation of the fluid delivery device 10 can be uploaded into the remote control device 100 and a unique identification of the remote control device 100 can be downloaded into the fluid delivery device 10 In a preferred embodiment the disposable fluid delivery device 10 does not include a unique identification as this may add cost to the manufacturing process Instead at first communication with a new fluid delivery device 10 the remote control device 100 is programmed to download a unique identification to the new fluid delivery device 10 which in turn is programmed to store the unique identifica tion in its internal memory for the remainder of its life All subsequent communications between the remote control device 100 and the fluid delivery device 10 then include the unique identification previously downloaded to assure secure and proper communication between the remote con trol device 100 and the specific delivery device 10 For example the memory 107 of the remote control device 100 automatically assigns a new unique identifica tion to each new pump 10 at the initial communication and includes the unique identification in each communication with the pump to prevent the pump from receiving com mands from other remote control devices that may be in proximity with the pump 10 The initial communication and exchange of the unique identifications c
39. he fluid delivery device 10 In a preferred embodiment the fluid delivery device 10 can transmit signals as well as receive to provide two way communica tion with the remote control device Receipt of the assigned fluid delivery device identification can be transmitted by the fluid delivery device 10 to the remote control device 100 to confirm the initialization and subsequent communications The remote control device 100 memory may communi cate with many fluid delivery device 10 over the life of the remote control device 100 and thus a matrix of fluid delivery device identifications would be maintained in the memory of the remote control device 100 to avoid duplica tion of identifications In addition the remote control device 100 may transmit a unique identification for itself to the fluid delivery device 10 to insure that in all subsequent communications signals are received by the correct remote control device For practical purposed the unique identifi cation downloaded to the fluid delivery device 10 may include a unique prefix suffix or other part identifying the remote control device in a unique way as well as a unique additional identification code whereby the combined codes is the unique identification for the fluid delivery device and the entire unique code is checked at each transmission to insure proper correlation of both devices In the preferred embodiment in which the fluid delivery device 10 can transmit information t
40. ice 100 will include programming to allow it to communicate with many fluid delivery device 10 however perhaps not more than one at a time The remote control device 100 may include programming such that after an initial communication only that particular fluid delivery device 10 can be controlled until another initial communication infor mation transfer is performed with a new fluid delivery device 10 after which the previous fluid delivery device 10 may or may not be able to be controlled by that remote control device 100 Obviously it may be desirable to obtain information from a previously used fluid delivery device 10 so programming may allow information transfer or upload from the previously used fluid delivery device 10 to the remote control device 100 but prevent actual infusion pro gramming or other controls The remote control device may include programming or command sets which are available only to certain users such as the patient clinician diagnostic technician clinical technician product technician or other unique user Each of the functions may be password or otherwise controlled to limit access In all instances the remote control device 100 will include at least a transmitter and a medical treatment apparatus such as the fluid delivery device 10 will include at least a receiver In a preferred embodiment remote control device 100 further includes a receiver and the fluid delivery device 10 further includes a tr
41. ing upon commands received from the remote control device 100 a check of proper identification can eliminate the issue of a remote control device 100 communicating with the wrong medical treatment apparatus 1000 and vice versa A start up or initial communication mode therefore is preferably conducted between the device 100 and the appa ratus 1000 wherein either or both of the unique identifica tions is exchanged followed by memory storage of either or both unique identifications In addition all subsequent com munications preferably include a confirmation of the proper identification prior to acceptance of instructions In some instances the remote control device 100 may download a uniquely assigned identification to the medical treatment apparatus 1000 which is then stored in the electronic memory of the medical treatment apparatus 1000 to estab lish a unique identification for that device Examples of identification assignment transfer and confirmation are described in more detail in subsequent exemplary embodi ments of the present invention It should be understood that the remote control device 100 may include software and electronic hardware for perform ing other functions such that the remote control device 100 is a multi function device Other functions can include that of a personal digital assistant such as the Palm Pilot Alternatively the other functions of the remote control device 100 can include one or more
42. instructions from the remote control unit the local communication unit also includes a wireless receiver connected to the local processor the remote communication unit of the remote control device includes a remote transmitter for sending the flow instructions to the local receiver and the user interface components of the remote control device include input components connected to the remote processor for allowing a user to enter the flow instructions 61 A kit including a system according to claim 52 and further comprising a subcutaneous access tool for connec tion to the exit port assembly of the fluid delivery device 62 A kit according to claim 61 including one of the remote control device a plurality of the fluid delivery devices and a plurality of subcutaneous access tools for connection to the exit ports of the fluid delivery device 63 A kit according to claim 62 wherein each fluid delivery device includes a bar code 64 system according to claim 52 wherein the fluid delivery device further comprises a reservoir and the dis penser controls fluid flow from the reservoir to the exit port assembly 65 A system according to claim 64 wherein the fluid delivery device further comprises a fill port connected to the reservoir 66 A system according to claim 64 wherein the reservoir contains a therapeutic fluid 67 system according to claim 66 wherein the fluid comprises insulin
43. ited by examiner U S Patent Jul 27 2004 Sheet 1 of 7 US 6 768 425 B2 U S Patent Jul 27 2004 Sheet 2 of 7 US 6 768 425 B2 FIG 2B U S Patent Jul 27 2004 Sheet 3 of 7 US 6 768 425 B2 U S Patent Jul 27 2004 Sheet 4 of 7 US 6 768 425 B2 VOLTAGE vn VT2 TIME FIG 4 U S Patent Jul 27 2004 Sheet 5 of 7 US 6 768 425 B2 mn 100 Kd U EG TIE gt ENE En mmm nen ENTER GRNT GR UNGER GR VAGN GRU ant U S Patent Jul 27 2004 Sheet 6 of 7 US 6 768 425 B2 oak 10 352 353 Je 26 FIG 6 100 ER 110 250 120 J FIG 6B FIG 6A U S Patent Jul 27 2004 Sheet 7 of 7 US 6 768 425 B2 ee INITIAL CONTACT ID RCID FDDID 70 FIG 7 RCID FDDID CODED TRANSMISSION 70 RCID FDDID CODED US 6 768 425 B2 1 MEDICAL APPARATUS REMOTE CONTROL AND METHOD CROSS REFERENCE TO RELATED APPLICATIONS The present application claims priority to provisional U S patent application Ser No 60 257 756 filed on Dec 21 2000 which is assigned to the assignee of the present application and incorporated herein by reference The present application is related to U S patent application Ser No 09 943 992 filed on Aug 31 2001 which is assigned to the assignee of the present application and incorporated herein by reference FIELD OF THE INVENTION The present invention relates generally to handhe
44. l assistant a glucometer diag nostic function a barcode reader and an electronic game The memory may also be used to store clinical therapy information such as diabetes care guide a troubleshooting guide and user manual for the medical treatment apparatus being remotely controlled and a troubleshooting guide and user manual for the remote control device 100 Also included within the housing 102 is an alarm 106 mounted to the printed circuit board 101 The alarm 106 preferably is an audio alarm such as a piezo buzzer com mercially available from Star Micronics Company Ltd of Edison N J The alarm 106 is activated by the electronics 105 when an alert or alarm condition is encountered during operation of the remote control device 100 Alarms may be predicated by a condition in the remote control device 100 or an alarm condition detected in the medical treatment apparatus 1000 that has been uploaded into the remote control device 100 Examples of alarm conditions include detection of a malfunction low battery conditions or even an alarm clock function Examples of alarm conditions uploaded from the medical treatment apparatus 1000 include low battery conditions detection of malfunction empty reservoir in a fluid delivery device occlusion of flow in a fluid delivery device out of paper condition or out of communication range The communication element 160 is also shown mounted to the printed circuit board 101 and is electronically at
45. ld devices that perform multiple functions and more particu larly to a handheld device for remotely controlling one or more medical apparatuses in addition to performing other functions for a user BACKGROUND OF THE INVENTION Today there are various handheld electronic devices that are routinely carried by a large portion of the population on a daily basis Examples of these devices include cellular telephones such as those offered by Nokia or Motorola personal digital assistants PDA s such as those offered by Palm Inc handheld electronic games such as the Lunker Bass Fishing game by Radica garage door openers and various other handheld electronic devices that perform spe cific functions for a user In recent years technological advances have allowed significant enhancements in such handheld electronic devices including reduced size and weight longer battery life simplified user interfaces and other additional new features and improvements For example the addition of a touch screen panel such as that incorporated into the Palm Pilot personal digital assistant allows simple menu driven access to personal calendars address books to do lists and email Other handheld electronic devices include remote control devices such as those commonly supplied with televisions video cassette recorders VCR s and DVD players Using wireless communication such as radio frequency infrared or ultrasound these remote control devices
46. ltiple functions include some recent cellular telephones which have been manufactured with personal computer functions electronic address and calendar functions and built in internet access User controlled ambulatory infusion devices can be an ideal use for a remote control Ambulatory infusion pumps have been developed for delivering liquid medicaments to patient These infusion devices have the ability to offer sophisticated fluid delivery profiles accomplishing bolus requirements continuous infusion and variable flow rate delivery which can result in better efficacy of the drug and therapy and less toxicity to a patient s system An example of a use of an ambulatory infusion pump is for continuous subcutaneous infusion of insulin to diabetic patients Many diabetics require insulin intake to treat their disease and continuous subcutaneous infusion of insulin from an infu sion pump has been shown in numerous studies to greatly improve the immediate and long term health conditions of those patients These pumps can deliver insulin on a con tinuous basal basis as well as a bolus basis as shown for example in U S Pat No 4 498 843 to Schneider et al User controlled ambulatory infusion devices are an ideal use for a remote control since the infusion devices may be located out of reach of a patient or may be discreetly located beneath clothing or in a carrying pouch Since the diabetic patient utilizing an ambulatory infusion pump m
47. may be electrically disconnected or otherwise unused The second power supply 108B is not used to supply power for each function but a reduced number of functions including remote control of a medical treatment apparatus Preferably the second power supply 108B provides power only to the remote control function Determination of remaining energy level for each power supply 108A 108B can be performed by electronic voltage detectors electronic current detectors and integration of values of current used time duration measurements mea surements of types and duration of use a combination of any of the aforementioned techniques along with other energy consumption and battery level detection methods known to those of skill in the art Power supply 108A 108B selection based on power consumption management can be accom plished with electronic switches such as transistor or other semiconductors switching circuits It should be appreciated that the two power supplies 108A 108B can provide power to separate specific functions or there may be particular functions that are provided power by both power supplies Particularly the function of controlling a medical treatment apparatus can be powered by both power supplies 108A 108B while other functions are limited to just one of the two supplies 108A 108B for the purpose of insuring continued non interrupted remote control function In a particular embodiment the first power supply 108A suppli
48. ng to claim 1 wherein the remote control device includes a unique identification included in all communications between the medical treatment appara tus and the remote control device 4 A system according to claim 1 wherein the medical treatment apparatus comprises one of an external infusion pump an implanted infusion pump a pacemaker a cardiac defibrillator a neurostimulator an x ray machine an EKG machine a diagnostic device a glucometer a blood analyzer an electrocautery device an operating room table a monitor and a laparoscopic controller 5 A system according to claim 1 wherein the remote control device is also adapted to function as at least one of a cellular phone a personal digital assistant and an elec tronic game 6 A system according to claim 1 wherein the remote control device further includes electronic memory storing a user manual for the medical treatment apparatus 7 A system according to claim 1 wherein the wireless communication between the remote control device and the medical treatment apparatus is radio frequency signals 8 A system according to claim 1 wherein the remote control device further includes an alarm connected to the remote processor and the remote processor is programmed to activate the alarm upon a measured power level of a first of the separate power supplies failing below a predetermined minimum power level 9 A system according to claim 8 wherein the alarm comprises an audi
49. ns of possible embodiments and examples of multi function remote control devices medical treatment apparatus and systems kits and methods according to the present invention Referring first to FIG 1 there is illustrated generally at 100 an exemplary embodiment of a multi function remote control device constructed in accordance with the present invention The remote control device 100 includes a visual display 110 such as a liquid erystal display or LCD that is mounted to a housing 102 Preferably the display 110 is a touch screen display such as that included in touch screen monitors found in various equipment including the Palm Pilot personal digital assistant manufactured by Palm Inc of Santa Clara Calif Mounted to the housing 102 are electromechanical switches such as a membrane keypad 120 to allow the user to input data or activate commands The remote control device 100 also includes means of transmitting electronic signals including antenna 130 which is shown external to the housing 102 but is preferably contained within the outer surface of the housing 102 Examples of the internal electronics and other components of the device 100 are described in detail in subsequent sections The wireless communication is accomplished using one or more forms of electronic information transfer including radio frequency infrared or ultrasound communications or other forms of non wired electronic information transfer The device receiving th
50. ntrolled by a remote control device such as the remote control devices 100 of FIGS 2 and 3 via wireless electronic signals sent by 10 15 20 25 30 40 50 55 60 65 12 the remote control device and received by a communication element 60 referred to in the appended claims as a local communication element shown in FIG 3a Preferably the fluid delivery device 10 is a low cost disposable insulin pump and includes no user interface components and can only be interfaced with by a user via a remote control device In one embodiment the communication element 60 both receives and transmits electronic signals to the remote control device 100 Information transmitted by the fluid delivery device 10 may include alarm conditions program ming history infusion history confirmation of programming handshaking or other communication con firming codes or other electronic controls or information transfer Information can be transferred with standard wire less technologies such as radio frequency or infrared and include standard handshaking or other communication con firmation protocols such as those employed in commercially available modems and fax machines FIG 4 is a graph of voltage versus time of a power supply for a handheld electronic device The decay curves of voltage over time for typical use or typical battery drain is shown Referring also to FIG 3 such measurements of the general purpose power su
51. o claim 20 wherein the fluid delivery device further comprises a reservoir and the dis penser controls fluid flow from the reservoir to the exit port assembly 33 A system according to claim 32 wherein the fluid delivery device further comprises a fill port connected to the reservoir 34 A system according to claim 32 wherein the reservoir contains a therapeutic fluid 35 A system according to claim 34 wherein the fluid comprises insulin 36 A system for providing medical treatment to a patient comprising A a medical treatment apparatus including a local processor and a local communication element connected to the local processor B a remote control device separate from the medical treatment apparatus and including a remote processor user interface components connected to the remote processor a remote communication element connected to the remote processor and adapted to communicate with the local communication element of the medical treatment apparatus in a wireless manner such that information can be transferred between the local processor and the remote processor and a power supply connected to the remote processor wherein the remote processor is programmed to only conduct functions related to the transfer of informa tion between the local processor and the remote processor upon a measured power level of the power supply falling below a predetermined minimum power level 37 A system according to claim
52. o the remote control device the unique identification can be included in fluid delivery device 10 transmitted communications as well In an alternative embodiment the fluid delivery device 10 may be manufactured with a unique identification such as a serial number in its electronic memory In this configuration the fluid delivery device 10 would transmit the unique identification to the remote control device 100 in the initial communication in addition to the remote control device 100 transmitting its unique identification to the fluid delivery device 10 each device holding both unique codes in electronic memory and checking for proper device com munication at each transmission FIG 7 depicts the initial communication between devices where a remote control device identification RCID and a fluid delivery device identification FDDID are transmitted from remote control device 100 to the fluid delivery device 10 As described hereabove the unique identification can simply be a combination of the two device identifications with or without additional coded information The fluid delivery device identification FDDID can be generated by the remote control device 100 or already preprogrammed into fluid delivery device 10 at the time of manufacturing In this instance the code may be included in random access or RAM memory or in read only memory or ROM memory In the case where the unique identification is downloaded from the remote con
53. ogrammable and logic circuitry to perform programmable functions referred to in the appended claims as remote processor Other components of the electronics 105 can include digital circuitry analog circuitry resistors capacitors transistors US 6 768 425 B2 7 integrated circuits amplifiers additional microprocessors logic circuitry integrated circuits programmable logic ana log to digital converters digital to analog converters multiplexors and other semiconductor circuitry Preferably a microprocessor and associated circuitry is embedded into the electronics 105 and receives program ming signals from a membrane keypad 120 controls the visual display 110 and creates electronic command signals and identifiers to be broadcast in wireless form via the communication element 160 Embedded in the memory 107 of the electronics 105 or included in the microprocessor is one or more microprocessor based software programs that define control and facilitate the operation of the device 100 in a predetermined manner Combined with the memory 107 which can be one or more components integrated into electronics 105 can be fixed preprogrammed read only memory and variable read and writeable memory The memory 107 includes the pro gramming necessary to support all functions of the device 100 including remote control of the medical treatment apparatus as well as the other functions such as cell phone operation a personal digita
54. ol device include input components connected to the remote processor for allowing a user to enter the flow instructions 57 A system according to claim 56 wherein the fluid delivery device includes a housing containing the exit port assembly the dispenser the local processor and the wireless receiver and wherein the housing is free of user input components for providing the flow instructions to the local processor 58 A system according to claim 52 wherein the local processor of the fluid delivery device is pro grammed to provide flow information the local communication unit includes a wireless trans mitter for transmitting the flow information from the local processor the remote communication unit of the remote control device includes a remote receiver for receiving the flow information from the local transmitter and the user interface components of the remote control device include output components connected to the remote processor for allowing a user to receive the flow information 59 A system according to claim 58 wherein the fluid delivery device includes a housing containing the exit port assembly the dispenser the local processor and the local communication unit and wherein the housing is free of user output components for providing the flow information from the local processor to a user 60 A system according to claim 59 wherein the local processor is programmed to receive at least some of the flow
55. ons 23 to allow flexing Included within the housing 200 is a reservoir 30 which is designed and constructed to be compatible with the liquid medication such as insulin to be infused In a preferred embodiment the reservoir 30 is prefilled with the liquid medication however the entire reservoir can be inserted by the user if in the form of a prefilled cartridge not shown or the fluid delivery device 10 may include medication fill means such as a needle penetrable septum in fluid commu nication with the reservoir 30 also not shown The reservoir 30 is in fluid communication with a dispenser 40 which is used to precisely control the amount of fluid to exit the fluid delivery device 10 via exit port assembly 70 FIG 3a depicts an exit port assembly 70 including a standard attachment such as a Luer connector 71 which can be attached to a transcutaneous infusion set not shown for transcutaneous delivery of the liquid medication Alternatively the Luer connector 71 can be replaced with a transcutaneous cannula assembly that is integrated into exit port assembly 70 and obviates the need for the transcutaneous infusion set The dispenser 40 controls fluid flow from the reservoir 30 to the exit port assembly 70 and can comprise a linear or rotary peristaltie pump if the reservoir 30 is not pressurized Alternatively the dispenser 40 can comprise an electrody namic pump a displacement pump or other fluid pumping mechanism The dispenser 4
56. pply 108A can be used to by the remote control device 100 to determine when the dedicated power supply 108B is used to supply power to the remote control device 100 For example the internal electronics 105 can measure the energy level such as a voltage level of the first power supply 108A and when the level decreases below a certain value employ the second power supply 108B In FIG 4 the voltage curve is for the general purpose power supply 108A of FIG 3 A second voltage threshold VT2 is shown in FIG 4 and represents a predetermined energy level at which the dedicated power supply 108B is utilized The measurement electronics 105 may include means of detecting when the voltage of the general purpose power supply 108A first drops below the second voltage threshold VT2 such that if the voltage increases above the second voltage threshold VT2 thereafter the battery control conditions remain unchanged so that the dedicated power supply 108B remains connected Such a method of differ entiating a voltage level slightly above a threshold if the level had previously decreased below the threshold is known as a hysteresis function or method Once a threshold level is erossed minor measurement perturbations above the thresh old do not change the resulting actions from the initial erossing When the voltage exceeds the threshold by a more significant preset level such as that caused by new battery replacement or recharge the actions are revers
57. r download most particularly information which can be sent to the user to help manage troubleshoot and otherwise use the medical treatment apparatus being controlled The information can be uploaded or downloaded from a clinician or other health care giver the manufacturer of the remote control device 100 or the manufacturer of the medical treatment apparatus being remotely cointrolled Alternatively all of these upload and download commu nications can be accomplished via wireless technologies accepted by communication element 160 contained within the remote control device 100 In this wireless scenario communication can be sent via satellite or other global or near global communication updating each applicable remote control device 100 with new programming information text or user manual information or other data stored within the memory 107 The information can be received by communication element 160 whose primary function is to send and potentially receive wireless com munications to medical apparatus treatment apparatus 1000 FIG 6 shows a packaged assembly 350 which includes a fluid delivery device 10 similar to the fluid delivery devices of FIGS 2b and 3a The fluid delivery device 10 is packaged in an assembly tray 353 which can be constructed of a sterilizable material such as PETG or polycarbonate and is seal with an assembly lid 352 which can be constructed of sterilizable material such as Tyvek wrap material supplied
58. r other clinical or non clinical information The use of information barcode 26 containing unique device information versus including such unique information in the electronic memory of the fluid delivery device 10 may be more efficient and cost effective for mass production of the fluid delivery device 10 especially in designs and construc tions where the device is to be of extreme low cost for limited life or disposable use A preferred packaging construction to the tray and lid described above would be a sealable pouch common to the medical apparatus industry The pouches usually consist of a rectangular piece of breathable material such as Tyvek which is sealed to a piece of clear flexible plastic such as thin Mylar The pouch construction can be sterilized in similar fashion to the tray and lid packaging and is generally of less cost to manufacture without providing the rigid protection of the tray packaging FIG 6b depicts a top view of therapeutic fluid supply 250 Therapeutic fluid supply 250 may include a glass or plastic vial and may be filled with various types of one or more liquid medications such as insulin The therapeutic fluid supply 250 may be loaded like a cartridge into a properly designed and adapted fluid delivery device 10 or the con tents of therapeutic fluid supply 250 may be transferred through interlocking fluid connection or via syringe and needle into fluid delivery device 10 at a integral injection port
59. reatment apparatus itself such as a blood glucose measuring function for the diabetic patient controlling an ambulatory insulin pump The additional functions may be unrelated such as PDA cellular telephone or game functions Desired remote control devices therefore will obviate the need for a user to carry multiple handheld devices Preferably the remote control devices will include power consumption regulations that prioritize power delivery for the medical controlling func tions of the devices In addition the remote control devices will preferably include battery monitoring which substan tially avoids a total loss of power for the medical controlling function Moreover such remote control devices will be adapted for use with multiple medical treatment apparatus such as successive disposable infusion pumps SUMMARY OF THE INVENTION In response the present invention provides a remote control for a medical treatment apparatus that includes functions in addition to control of the medical apparatus as desired According to one exemplary aspect the multi function medical apparatus remote control device includes power consumption regulations that prioritize power deliv ery for the medical controlling functions of the devices According to another exemplary aspect the multi function medical apparatus remote control device includes battery monitoring which substantially avoids a total loss of power for the medical controlling function
60. s and developers Cygnus Corporation of Redwood City Calif for example manufacturers the Glucowatch Biographer blood glucose measuring system The glucometer port 150 can be adapted to electronically connect with a device such as the Gluco watch to transmit and receiving blood glucose information Alternatively the information can be communicated via wireless technologies described herein utilizing communi cation element 160 and a transmitting or receiving element included in the glucometer Alternatively the glucometer port 150 can be replaced with another input output or combination input and output port for allowing attachment to other devices performance of electro mechanical functions such as bar code scanning attachment to an information upload or download device or performance of another function As shown in FIG 2a the device 100 can also include a barcode reader port 140 for connecting to a standard barcode reader pen or gun not shown to simplify input of information such as drug type and concentration from a drug reservoir or vial Alternatively the barcode reader port 140 may include the integrated bar code reading technology and avoid the need for another device The device 100 also includes a computer port 170 for connection to a personal computer or other computer system to upload or download information as well as offering temporary computer control of various functions including programming or program modification o
61. seem less burdensome and may reduce the need to carry around a separate device such as a PDA cellular phone or other handheld electronic device The methods and design features described in this applica tion that relate to disposable fluid delivery devices can be applied to non disposable fluid delivery devices as well as other medical apparatus and should not in any way limit the scope of the remote control device 100 or the applicable systems Although exemplary embodiments of the invention have been shown and described many changes modifications and substitutions may be made by those having ordinary skull in US 6 768 425 B2 19 the art without necessarily departing from the spirit and scope of this invention For example a power supply has often been described as a battery such as a silver oxide battery If two or more silver oxide batteries were connected in series to increase voltage or if placed in parallel to increase the available supply of current they may be con sidered as a single power supply Combinations of batteries capacitors and other energy storage devices in series or parallel acting either as a single power supply or as multiple power supplies can be made without departing from the scope of this application Also various means of power or energy level detection have been described such as voltage level detection but various other means of measuring monitoring or otherwise calculating remaining energy can be
62. tached to the electronics 105 to feed the electronic signals or packets of information to and possibly from the communi cation element 160 Also electrically connected to the printed circuit board 101 and the electronics 105 thereon is the user interface components 110 120 In one exemplary embodiment a medical treatment appa ratus of the present invention comprises an ambulatory fluid delivery device 10 as shown in FIG 2b The fluid delivery device 10 is for the infusion of insulin for diabetic patients and an additional function of the remote control device 100 is a glucose measurement device or glucometer function In such an embodiment the remote control device 100 includes the necessary hardware to measure blood glucose such as that taken from a blood sample so that a diabetic patient can avoid the need to carry multiple handheld devices i e one for controlling the fluid delivery device and one for mea suring blood glucose Thus as shown in FIG 2 the remote control device 100 includes a glucometer port 150 which can comprise a 10 15 20 30 35 40 45 50 55 60 65 8 standard wire connector allowing attachment to an existing glucometer device or a more sophisticated input device for measuring blood glucose utilizing optics or sensors for analyzing blood glucose strips or blood drops Non invasive blood glucose technologies are commercially available or in development by various manufacturer
63. ther exemplary embodiment of a remote control device constructed in accordance with the present invention FIG 3a is a sectional side view of another exemplary embodiment of an ambulatory infusion device constructed in accordance with the present invention FIG 4 is a chart illustrating voltage decay over a period of time and low battery level thresholds for a remote control device constructed in accordance with the present invention FIG 5 is a top plan view of a further exemplary embodi ment of a remote control device constructed in accordance with the present invention FIG 5a is a sectional view of the remote control device of FIG 5 taken along line a a of FIG 5 FIG 6 is a top plan view of a packaged assembly of a medical treatment apparatus assembled in accordance with the present invention FIG 6a is a top view of a remote control device of the packaged assembly of FIG 6 FIG 6b is a top view of a vial of liquid medication of the packaged assembly of FIG 6 and FIGS 7 7a and 7b are perspective views illustrating an exemplary embodiment of a method of wireless communi cation according to the present invention conducted between a remote control device and a fluid delivery device of the present invention Like reference characters designate identical or corre sponding components and units throughout the several views DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS Set forth hereinbelow are detailed descriptio
64. tional alarm The unique identification of either device may include alpha numeric designators or simple binary digits or a binary representation of a more sophisticated code The transmissions may include digital or more sophisticated waveforms each including the unique codes representing either or both the medical treatment apparatus devices The fluid delivery device 10 programming can be made such that after the initial communication with a remote control device 100 the fluid delivery device will only accept command codes from transmissions received with that remote control device 100 unique identification remote control device identification RCCID Alternatively the fluid delivery device 10 programming may allow control from multiple remote control device 100 with more complex acceptance schemes The remote control device 100 may include pro gramming and unique identifications that identify master remote control devices or remote control devices that are used for diagnostic troubleshooting clinician or other purposes Control of a fluid delivery device 10 by a remote control device 100 that did not initialize that particular fluid 10 15 20 25 30 35 40 45 50 55 60 65 18 delivery device 10 may involve special passwords keys or other special functions or actions to allow the fluid delivery device 10 to accept the commands from the new remote control device 100 Conversely the remote control dev
65. trol device 100 the unique identification would be stored in RAM Alternatively a label containing a barcode as described hereabove can be read by the remote control device 100 and subsequently downloaded into the electronic memory of the fluid delivery device 10 US 6 768 425 B2 17 FIG 7b depicts a subsequent electronic wireless com munication including the remote control device identifica tion RCID and including the fluid delivery device identifi cation FDDID in addition to other programming control command or other information sent from the remote control device 100 to fluid delivery device 10 Prior to action related to the command codes sent a check would be performed to confirm completion and accuracy of the message using checksum or other appropriate techniques as well as a check that the proper remote control device 100 had sent the information to the proper fluid delivery device 10 After acceptable confirmations a return signal may be sent to acknowledge acceptance and then appropriate actions would take place in the fluid delivery device 10 FIG 7c depicts a subsequent electronic wireless com munication including the remote control device identifica tion RCID and including the fluid delivery device identifi cation FDDID in addition to other programming control command or other information sent from the fluid delivery device 10 to remote control device 100 Prior to action related to the command codes sent a
66. us comprises a fluid delivery device also including an exit port assembly and a dispenser for causing fluid from a reservoir to flow to the exit port assembly wherein the local processor is connected to the dispenser and is programmed to cause fluid flow to the exit port assembly based upon flow instructions 53 A system according to claim 52 wherein the exit port assembly of the fluid delivery device includes a transcuta neous access tool 54 A system according to claim 52 wherein the local processor is programmed to cause fluid flow to the exit port assembly only upon receiving the flow instructions from the remote control device 55 A system according to claim 52 wherein the fluid delivery device is packaged in a container for shipping and handling prior to use 56 A system according to claim 52 wherein the local processor of the fluid delivery device is pro grammed to cause a flow of fluid to the exit port assembly based solely on flow instructions from the separate remote control device the local communication unit includes a wireless receiver for receiving the flow instructions and delivering the flow instructions to the local processor the remote communication unit of the remote control device includes a remote transmitter for sending the flow instructions to the local receiver and a 10 15 20 25 35 40 45 50 55 60 65 24 the user interface components of the remote contr

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