US20070100283A1 - Control tabs for infusion devices and methods of using the same - Google Patents

Abstract

An external infusion device that infuses a fluid into an individual's body includes a housing, a reservoir, a drive system, a power supply, electrical elements, and a tab. The reservoir contains the fluid, and the drive system forces the fluid from the reservoir. The electrical elements control the power to the drive system to regulate the rate that fluid is forced from the reservoir. The tab mates with the housing, and contains at least one electrical element. The tab is removable, and may be replaced with a different tab. The different tab may change the rate fluid is forced from the reservoir. A tab may be removed from one external infusion device and installed in a different external infusion device. The tab may be limited to use in a predetermined number of external infusion devices and may include a power supply.

Description

RELATED APPLICATIONS
• This application is a continuation of U.S. patent application Ser. No. 09/672,244, filed on Sep. 28, 2000, and entitled “Cost-Sensitive Application Infusion Device,” which is a continuation of U.S. patent application Ser. No. 09/533,578, filed on Mar. 23, 2000, and entitled “Cost-Sensitive Application Infusion Device,” both of which are specifically incorporated by reference herein.
FIELD OF THE INVENTION
• This invention relates to external infusion devices and, in particular embodiments to external infusion devices that control the rate that a fluid is infused into an individual's body.
BACKGROUND OF THE INVENTION
• Portable personal infusion devices and systems are relatively well-known in the medical arts, for use in delivering or dispensing a prescribed medication to a patient. Many pharmaceutical agents are delivered into the subcutaneous tissue and the most common is insulin. Currently, more than 70,000 patients in the U.S. and 30,000 more patients worldwide use continuous subcutaneous infusion of insulin (CSII) for the treatment of diabetes mellitus. However, other medications that are infused include HIV drugs, drugs to treat pulmonary hypertension, iron chelation drugs, pain medications, and anti-cancer treatments.
• Traditionally, low cost infusion devices have used an elastomeric diaphragm, sponge rubber, balloon or gas generator to expel fluid to be infused into a patient over a period of time at a single, relatively constant rate. A drawback to these devices is that they are only filled with fluid once. When the infusion of fluid is complete, the infusion device is disposed of. Thus, the infusion device must be made at an extremely low cost. Another drawback is that the low cost may not allow for the high quality needed to have sufficient flow rate control accuracy for the delivery of dosage sensitive drugs.
• To obviate these drawbacks, infusion devices have been designed with more accurate dosage control, but at a significantly higher cost. To compensate for the relatively high cost, the more accurate infusion devices are designed to be refilled and reused.
• In one form, refillable infusion devices comprise a relatively compact housing adapted to receive a syringe or reservoir carrying a prescribed medication for administration to the patient through infusion tubing and an associated catheter or infusion set. Such infusion devices are utilized to administer insulin and other medications, with exemplary infusion device constructions being shown and described in U.S. Pat. Nos. 4,562,751; 4,678,408; 4,685,903; 5,080,653 and 5,097,122, which are incorporated by reference herein.
• While the sophisticated electronics and robust mechanics of the more expensive refillable infusion devices provide a more reliable and accurate infusion device, the cost of manufacturing may make the refillable infusion device too expensive for some users or medications. On the other hand, the low cost, one-time-use, constant flow rate infusion devices may not have sufficient flow rate accuracy or the adjustments needed to control the dosage for some users.
SUMMARY OF THE DISCLOSURE
• According to an embodiment of the invention, a reusable external infusion device with a predetermined usage life for infusing a fluid into a body includes a replaceable reservoir, a power supply, a drive system, an electronics system, and a housing. The housing contains the reservoir, power supply, drive system, and electronics system. The replaceable reservoir contains the fluid before infusing and has a usage life substantially shorter than the predetermined usage life of the infusion device. The power supply provides power to the drive system and the electronics system to force fluid from the reservoir. The electronics system regulates the power from the power supply to control the drive system.
• In particular embodiments of the present invention, the infusion device includes a control system operatively coupled to the electronics system that adjusts one or more control parameters.
• In more particular embodiments, the control system is a supplemental device. In additional embodiments, the supplemental device establishes two way communication with the electronics system. In particular embodiments, the supplemental device has a display.
• In preferred embodiments, after the infusion device's predetermined usage life has expired, the infusion device may be refurbished at least once to function for another predetermined usage life. In particular embodiments, when the predetermined usage life for the infusion device expires, the infusion device ceases to infuse fluid. In further particular embodiments, the predetermined usage life for the infusion device is programmed into a software program as a number of times that the replaceable reservoir is replaced in the infusion device.
• In preferred embodiments, the drive mechanism of the infusion device contains a DC motor in the drive system. In alternative embodiments, the drive mechanism of the infusion device contains a stepper motor, solenoid motor, a shape memory alloy driven motor, or the like.
• According to another embodiment of the present invention, a reusable external infusion device is for infusing a fluid into an individual. In preferred embodiments, the infusion device includes a housing and a replaceable fluid containing reservoir that is inserted into the housing.
• In preferred embodiments, the housing contains only one electronics module to control the infusion device. In particular embodiments, the electronics module contained within the housing is produced using chip-on-board construction. In other particular embodiments, the electronics module contained within the housing is produced using ball grid array construction. In further embodiments, the electronics module a flex circuit to control the infusion device. In preferred embodiments, the housing contains a detection device that detects the presence or absence of the replaceable reservoir. In further preferred embodiments, the reusable external infusion device further includes a drive mechanism coupled to an electronics system and the housing includes a button coupled to the electronics system that an individual may push to cause the drive mechanism to deliver a bolus of fluid into the individual.
• In additional preferred embodiments, the housing and internal contents are assembled together without screws. In more preferred embodiments, the housing includes at least one feature that is fused using ultrasonic vibrations. In other preferred embodiments, the housing includes a drive mechanism that contains at least one non-metallic gear.
• In preferred embodiments, the housing includes a slidable key that provides access to remove and/or replace the replaceable reservoir inside the housing. In particular embodiments, the housing accepts a key that includes a communication device for communicating with a supplemental device. In alternative embodiments, the housing accepts a tab that includes a communication device for communicating with a supplemental device. In further alternative embodiments, the housing accepts a tab/key that includes a communication device for communicating with a supplemental device.
• In further preferred embodiments, the housing includes an opening to insert a removable tab that includes a programmable chip that contains at least one control parameter to control the infusion device. In further embodiments, the housing includes an opening to insert a tab that includes at least one electrical terminal that establishes electrical contact between at least one set of electrical terminals inside the housing. In particular embodiments, the housing is adapted to receive at least one of at least two different tabs that are insertable into the housing, and the at least two different tabs each have different electrical terminal configurations that establish electrical contact between different electrical terminals inside the housing, and connects different electrical terminals to cause the external infusion device to dispense fluid at different rates. In still further embodiments, the housing is adapted to receive at least one tab with an optically readable pattern, and the housing includes an optical reader to read the optically readable pattern on the at least one tab to control at least one control parameter of the reusable external infusion device. In alternative embodiments, the housing is adapted to receive at least one tab that includes magnetically stored information, and the housing includes a magnetic reader to read the magnetically stored information from the at least one tab to control at least one control parameter of the reusable external infusion device.
• In preferred embodiments, the reusable external infusion device includes at least one lithium magnesium oxide (LiMnO₂) battery. In particular embodiments, the reusable external infusion device includes a battery that lasts at least 10 weeks, measured while the reusable external infusion device dispenses up to 40 milliliters of fluid per day and while the alarms draw substantially no power from at least one battery.
• In additional particular embodiments, an alarm is activated when the reusable external infusion device needs to be refurbished. In preferred embodiments, the reusable external infusion device has a predetermined usage life and when the predetermined usage life has expired, the reusable external infusion device may be refurbished at least once to function for another predetermined usage life. In particular embodiments, the reusable external infusion device has a predetermined usage life and when the predetermined usage life expires, the reusable external infusion device ceases to infuse fluid.
• In further particular embodiments, the reusable external infusion device has a predetermined usage life and the predetermined usage life for the reusable external infusion device is programmed into a software program as a number of times that the replaceable reservoir is replaced in the housing, as a number of days that the reusable external infusion device is in use, as the number of times the battery is replaced in the reusable external infusion device, and/or as the number of times that a key is removed from the reusable external infusion device. In other embodiments, the reusable external infusion device has a predetermined usage life and the predetermined usage life for the reusable external infusion device is expired when the amount of electrical power consumed to empty a reservoir exceeds a predetermined amount programmed into a software program.
• According to an embodiment of the invention, an external infusion device for infusing a fluid into a body includes a housing, a reservoir, a drive system, at least one power supply, one or more electrical elements, and a tab. The housing contains the reservoir and the drive system. The reservoir contains the fluid, and the drive system forces the fluid from the reservoir. The drive system is powered by the at least one power supply. The one or more electrical elements are coupled to the power supply and the drive system to regulate the rate that the drive system forces fluid from the reservoir. The tab mates with the housing, and contains at least one of the one or more electrical elements. In preferred embodiments, the tab is removable, and in particular embodiments is replaceable with a different tab. In some embodiments, the different tab changes the rate that the drive system forces fluid from the reservoir. In particular embodiments, the tab may be removed from one external infusion device and mated with a different external infusion device to affect the operation of the different external infusion device. In other particular embodiments, the tab may only be used in a predetermined number of external infusion devices. In further embodiments, the tab includes at least one of the at least one power supply.
• In preferred embodiments, the tab is insertable into an opening in the housing, and may include a seal to improve resistance to water or contaminants entering the housing. Alternatively, the tab is attachable to the exterior of the housing. In alternative embodiments, the housing includes a seal that is in contact with the tab to improve resistance to water or contaminants entering the housing.
• In alternative embodiments, the tab is disposable, and in some embodiments, the tab, once it is installed, is not removable from the housing. In other embodiments, the reservoir of the external infusion device can only be filled once.
• In preferred embodiments, the tab affects whether a medicament filling apparatus can mate with the infusion device. In alternative embodiments, the tab affects whether or not a fluid path between a medicament filling apparatus and the reservoir is open.
• In particular embodiments, the tab includes all of the one or more electrical elements. In other embodiments, the tab includes at least a portion of the drive system. In still other embodiments, the tab includes the drive system. In yet another embodiment, the tab includes one or more components that are sensitive to sterilization treatments. And in still another embodiment, the tab includes one or more components that are reusable.
• In particular embodiments, the tab includes one or more indicators. In preferred embodiments, the one or more indicators indicate that the drive system is powered. In other embodiments, the one or more indicators indicate that fluid delivery is in process. And in still other embodiments, the one or more indicators indicate a power supply status.
• According to an embodiment of the invention, a tab for an external infusion device having a housing containing a reservoir for fluid to be infused into a body and a drive system to force the fluid from the reservoir powered by at least one power supply and controlled by one or more electrical elements includes a support structure and at least one of the one or more electrical elements. The support structure mates with the housing of the external infusion device, and the at least one of the one or more electrical elements is attached to the support structure. In preferred embodiments, the tab affects the rate that the fluid is infused into the body. Furthermore, the tab is insertable into an opening in the housing, and includes a seal to improve resistance to water or contaminants entering the housing. In alternative embodiments, the tab is attachable to the exterior of the housing. In other alternative embodiments, once the tab is installed, it contacts a seal on the housing that improves resistance to water or contaminants entering the housing.
• In preferred embodiments, the tab is removable, and in some embodiments, the tab may be removed form one external infusion device and mated with a different external infusion device to affect at least one control parameter of the different external infusion device. In particular embodiments, the tab may only be used in a predetermined number of external infusion devices.
• In alternative embodiments, the tab is disposable and in some embodiments, after it is installed, the tab is not removable from the housing. In further alternative embodiments, the tab can only be used once. In other alternative embodiments, the tab includes at least one of the at least one power supply. In further embodiments, the tab includes at least a portion of the drive system.
• In some embodiments, the tab affects whether a medicament filling apparatus can mate with the infusion device. In other embodiments, the tab affects whether or not a fluid path between a medicament filling apparatus and the reservoir is open.
• Other features and advantages of the invention will become apparent from the following detailed description, taken in conjunction with the accompanying drawings, which illustrate, by way of example, various features of embodiments of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
• A detailed description of embodiments of the invention will be made with reference to the accompanying drawings, wherein like numerals designate corresponding parts in the several figures.
• FIG. 1 is a block diagram, illustrating an infusion device and a supplemental device according to an embodiment of the present invention.
• FIG. 2 is a perspective view of an infusion device connected to a tube, an infusion set and an individual's body according to an embodiment of the present invention.
• FIG. 3 is a perspective view of an electronics module in accordance with an embodiment of the present invention.
• FIG. 4 is a perspective view of a flex circuit in accordance with an embodiment of the present invention.
• FIG. 5 is a partial perspective view of an infusion device drive system in accordance with an embodiment of the present invention.
• FIG. 6 is a cross-sectional view showing “Tinnerman” style retaining rings holding gear hubs in accordance with an embodiment of the present invention.
• FIG. 7 is a partial perspective view of internal components of an infusion device with multiple batteries in accordance with another embodiment of the present invention.
• FIG. 8 is a perspective view of an infusion device with a key slid out of the housing in accordance with an embodiment of the present invention.
• FIG. 9 is a partial perspective view of an infusion device with a key that has electrical traces in accordance with another embodiment of the present invention.
• FIG. 10 is a perspective view of the infusion device ofFIG. 8 with the housing removed to show the internal components and the key.
• FIG. 11 is a perspective diagram of an infusion device connected to a computer in accordance with an embodiment of the present invention.
• FIG. 12 is a perspective diagram of an infusion device connected to a personal digital assistant in accordance with an embodiment of the present invention.
• FIG. 13 is a perspective diagram of an infusion device communicating with a dedicated programming device in accordance with an embodiment of the present invention.
• FIG. 14 is a partial perspective view of an infusion device with a tab that has electrical traces in accordance with a further embodiment of the present invention.
• FIG. 15 is a perspective view of two tabs with different electrical traces in accordance with an embodiment of the present invention.
• FIG. 16 is a perspective view of two keys with different electrical traces in accordance with an embodiment of the present invention.
• FIG. 17 is a partial perspective view of an infusion device with a tab that has a programmable chip in accordance with an embodiment of the present invention.
• FIG. 18 is a partial perspective view of an infusion device with a key that is that has a programmable chip in accordance with an embodiment of the present invention.
• FIG. 19(a) is a perspective view of a communication key with a slot to accept a connector in accordance with an embodiment of the present invention.
• FIG. 19(b) is a perspective view of a communication key with a connector and wire attached in accordance with an embodiment of the present invention.
• FIG. 20 is a perspective view of a communication key for RF communication in accordance with an embodiment of the present invention.
• FIG. 21 is a perspective view of a communication key for IR communication in accordance with an embodiment of the present invention.
• FIG. 22 is a plan view of the internal components of an infusion pump in accordance with an embodiment of the present invention.
• FIG. 23(a) is a partial cutout perspective view of an infusion device with a tab in accordance with an embodiment of the present invention.
• FIG. 23(b) is a top plan view showing a rough layout of internal components of an infusion device, which has a tab in accordance with an embodiment of the present invention.
• FIG. 24(a) is a partial cutout perspective view of an infusion device with a tab containing at least one battery in accordance with an embodiment of the present invention.
• FIG. 24(b) is a top plan view showing a rough layout of internal components of an infusion device, which has a tab containing at least one battery in accordance with an embodiment of the present invention.
• FIG. 25(a) is a partial cutout perspective view of an infusion device with a tab containing at least one battery, at least one electrical component, and a drive system in accordance with an embodiment of the present invention.
• FIG. 25(b) is a top plan view showing a rough layout of internal components of an infusion device, which has a tab containing at least one battery, at least one electrical component, and a drive system in accordance with an embodiment of the present invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
• As shown in the drawings for purposes of illustration, the invention is embodied in a reusable external infusion device for infusing a fluid into an individual's body and methods of manufacturing the same. The infusion device controls the rate that fluid flows from a reservoir inside a housing, through an external tube, and into the individual's body. In preferred embodiments, the infused fluid is insulin. In alternative embodiments, many other fluids may be administered through infusion such as, but not limited to, HIV drugs, drugs to treat pulmonary hypertension, iron chelation drugs, pain medications, anti-cancer treatments, vitamins, hormones, or the like.
• In preferred embodiments, as shown inFIG. 1, aninfusion device10 includes areservoir12, adrive system14, anelectronics system16, acontrol system18, and apower supply20, all contained within ahousing22. The fluid is pushed from thereservoir12 by thedrive system14 when commanded by theelectronics system16. Thepower supply20 provides power to both thedrive system14 and theelectronics system16. A user or another qualified person, such as a doctor, parent, or spouse interfaces with theelectronics system16 through thecontrol system18. In preferred embodiments, fluid flows from theinfusion device10, through theexternal tube24, into an infusion set26, and then into the individual'sbody28, as shown inFIG. 2. Infusion sets26 that may be used in conjunction with theinfusion device10 are described in, but not limited to, U.S. Pat. Nos. 4,723,947; 4,755,173; 5,176,662; and 5,584,813; and disclosed in U.S. patent application Ser. No. 09/034,626 (attorney docket PD-0269), filed Mar. 4, 1998 and entitled “Medication Infusion Set”, which are hereby incorporated by reference.
• Thecontrol system18 provides a method for the user or another qualified person to adjust one or more control parameters that theelectronics system16 uses to calculate and issue commands to thedrive system14. Control parameters include, for example, one or more basal rates, one or more bolus rates, maximum and minimum delivery rates, one or more alarm criteria, or the like.
• In preferred embodiments, theelectronics system16 is a compilation of one or more electrical elements designed to carryout commands as specified by the control parameters. Electrical elements may include, but are not limited to, resistors, capacitors, amplifiers, diodes, semiconductor circuits, traces, wires, antennae, buttons, sound emanating devices, light emitting devices, receivers, transmitters, switches, or the like. In preferred embodiments, the electrical elements are attached to a single electronics board to form an electronics module. In particular embodiments, anelectronics module30 is a “popsickle stick” design, as shown inFIGS. 3, 5,10 and22. The term “popsickle stick” refers to the electronics module's long thin layout that optimizes the usage of space within thehousing22. With the “popsickle stick” design, theelectronics module30 stretches the length of thehousing22 so that only short leads are needed to extend from theelectronics module30 to any component that uses electricity or signals from the electronics. The use of a “popsickle stick” design also facilitates ease of assembly and integrating for theinfusion device10.
• In alternative embodiments, the electrical elements of the electronics module are mounted on a flex circuit. Preferably, the flex circuit has one or more flex circuit leads34 that run to various locations within thehousing22 to minimize or eliminate the need for wires. An example of one embodiment of aflex circuit32 is shown inFIG. 4. Flex circuit leads34 may run to amotor36, anantenna38, one ormore LEDs40, one ormore buttons42, abattery44,electrical elements46, or the like. In additional embodiments, theflex circuit32 may connect to other devices or components such as a transmitter, a receiver, a display, an alarm, a tab, a communication port, a power port, or the like. In additional embodiments, one or more semiconductor circuits are wire bonded to theflex circuit32.
• In preferred embodiments, theelectronics module30 includes chip-on-board construction. In alternative embodiments, theelectronics module30 includes ball grid array (BGA) packages or leaded chip construction.
• In preferred embodiments, theelectronics system16 includes one ormore LEDs40 to indicate specific conditions about theinfusion device10, such as whether the fluid is being dispensed, the battery power level, the fluid level in thereservoir12, whether theelectronics system16 is functioning, warnings regarding how soon theinfusion device10 will require servicing, or the like. In preferred embodiments, theelectronics system16 includes one or more alarms. Preferably, an alarm is a piezo electric sound device. In alternative embodiments, the one or more alarms includes a vibrator, a light, a sound emanating device, or the like.
• In preferred embodiments, as shown inFIGS. 5 and 22, thedrive system14 includes a motor/gear box48 with adrive shaft50 that extends out of the motor/gear box48, one ormore gears52 external to the motor/gear box48 that transfers motion from thedrive shaft50 to alead screw54, and apiston56 that is coupled to thelead screw54, such that as thelead screw54 rotates, thepiston56 moves aplunger58 inside thereservoir12. The angular rotation of amotor shaft136 is measured with anoptical encoder138 attached to an end of amotor shaft136 protruding from the motor/gear box48. In other embodiments, thedrive system14 may also be the same as or similar to the drive mechanism described in, U.S. patent application Ser. No. 09/429,352 (attorney docket PD-0286), filed Oct. 28, 1999 and entitled “Compact Pump Drive System”, which is hereby incorporated by reference. In particular embodiments, the motor/gear box48 includes a stepper motor. In alternative embodiments, the motor/gear box48 uses a direct current (DC) motor, a solenoid motor or a shape memory alloy (SMA) driven motor. The SMA motor may be of the type described in U.S. patent application Ser. No. 09/249,666, filed on Feb. 12, 1999, entitled “Incremental Motion Pump Mechanisms Powered By Shape Memory Alloy Wire Or The Like”, which is hereby incorporated by reference. The SMA motor may include a ratchet/pawl mechanism actuated by a SMA component.
• In preferred embodiments, the one ormore gears52 external to the motor/gear box48 have a one-to-one gear ratio. However, in alternative embodiments, the gears may have different gear rations such as 1.5:1, 2:1, 3:1, 5:1, or the like depending on the motor control resolution and the minimum dosage requirement for the fluid. In particular embodiments, thegears52 are made of molded plastic. In alternative embodiments, thegears52 are made of metal, epoxy, laminates, or other suitably strong materials. In alternative embodiments, mechanical power is transferred from the motor/gear box48 to thelead screw54 using one or more of a belt, timing belt, chain, gears, rack or the like.
• As shown onFIG. 6, in preferred embodiments, each of thegears52 have agear hub60 that fits through one of theopenings62 in awall64 contained within thehousing22. A “Tinnerman”style retaining ring66 slips over thegear hub60 of eachgear52 to secure thegear52 to thewall64. In alternative embodiments, eachgear hub60 is held in place with a snap ring, a rivet, a threaded nut, a press-on nut, or the like. In preferred embodiments, eachgear52 has a “D” shapedhole68 passing entirely through thegear52 that is located generally at the center of rotation. Thedrive shaft50, with a mating “D” shapedend51, fits into the “D” shapedhole68 in agear52. In addition, a “D” shapedend55 of thelead screw54 fits into a “D” shapedhole68 in agear52. The “D” shapedholes68 function to transmit torque from thedrive shaft50 to thegears52 and on to thelead screw54 without the need for a fixed attachment of thedrive shaft50 and thelead screw54 to thegear hubs60. In alternative embodiments, other shaped holes are used such as hexagonal, square, rectangular, polygonal, triangular, oval, star, clover, round, notched, or the like along with a drive shaft and a lead screw with mating ends that fit into the holes.
• As shown inFIG. 5, in preferred embodiments, thepiston56 has a threadedbore70 that is generally centered with the piston's longitudinal axis, and thethreads72 on thelead screw54 mate with the threaded bore70 on thepiston56. Preferably only the first half of an inch of the piston bore70 is threaded and the remainder of the bore through the rest of the piston is smooth with a large enough diameter to allow the lead screw to pass through unobstructed. Alternatively, the length of the piston bore that is threaded may be increased or decreased depending on the number of threads needed to apply force to the plunger and the amount of friction generated between the piston bore70 and thelead screw54. Preferably, thepiston56 includes aflange74 with anotch76 that fits over arail78. Therail78 runs generally parallel to thelead screw54. As thelead screw54 rotates, an edge of thenotch76 in thepiston flange74 rests against therail78 and prevents thepiston56 from rotating. Therefore, as thelead screw54 rotates, thepiston56 moves along the length of thelead screw54 substantially free of rotational movement. In alternative embodiments, the threaded bore70 in thepiston56 is not generally centered with the piston's centerline. For example, thelead screw54 may pass through the piston'sflange74.
• In preferred embodiments, the power supply is abattery44. In particular embodiments, the power supply is a lithium magnesium oxide (Li Mn O₂)battery44, as shown inFIGS. 4, 5 and10. Some of the factors that influence the size of thebattery44 are, the amount of power needed to drive the motor/gear box48, the amount of friction through out thedrive system14, the size of the reservoir12 (and therefore the amount ofpiston56 displacement needed to empty the reservoir12), the dosage resolution required, the dosage volume, whether or not alarms are set off, how frequently lights or displays are used, and the number of days desired betweenbattery44 replacement. In preferred embodiments, thebattery44 lasts at least 10 weeks, while thereusable infusion device10 dispenses fluid at a rate of up to 40 milliliters per day without alarms. At greater fluid dispensing rates and/or when the alarms are active, the battery duration may be diminished. In preferred embodiments, with a 3ml reservoir12, the battery capacity is generally 2.1 amp-hours at 3 volts. In other embodiments, with a 1.5ml reservoir12′, such as shown inFIG. 7, the combined capacity of a pair ofbatteries80, shown inFIG. 7, is generally 1.1 amp-hours at 3 volts. In alternative embodiments, thebattery44 may last as little as 3 days (a common time to empty a reservoir12) with a battery capacity as low as 0.035 amp-hours. Or, thebattery44 may last as long as a year (a likely time to have theinfusion device10 serviced) with a better battery capacity as large as 12.6 amp-hours. And in other alternative embodiments, the battery voltage may be as low as 0.5 volts and as large as 9 volts depending on the power needed for thedrive system14 andelectronics system16. In further alternative embodiments, two or more batteries (FIG. 7) may be used to supply the voltage and capacity needed to operate theinfusion device10.
• In preferred embodiments, thebattery44 andreservoir12 are removable through anopening82 in thehousing22, and theopening82 may be closed by sliding a key84 into aslot83 formed in thehousing22 so that the key84 covers thebattery44 and slides over theshoulder86 of thereservoir12, as shown inFIGS. 8, and10. In this embodiment, the key84 may be slid part way out of theslot83 of thehousing22 to a detent position that provides a sufficient opening to remove thereservoir12 from thehousing22 while retaining thebattery44 in place within thehousing22. Thebattery44 and thereservoir12 may both be removed from thehousing22 by entirely removing the key84 from theslot83 to fully expose theopening82. In alternative embodiments, two different sliding keys (not shown) are used, one to slide over thebattery44 and another to slide over theshoulder86 of thereservoir12.
• In preferred embodiments, the key84 has aconductive trace85 that connects abattery terminal88 of thebattery44 to apower lead87 on the electronics module30 (seeFIG. 8). Alternatively, the entire back of the key84 could be conductive. Therefore, if the key84 is removed, battery power is removed from theelectronics system16. In preferred embodiments, a capacitor, or other charge storage device, maintains electrical power for at least 15 seconds and up to 3 minutes after thebattery44 is disconnected from theelectronics system16. This allows an individual time to replace thebattery44 without losing electrically stored information in theelectronics system16. In alternative embodiments, a commonly known DC converter is used to convert AC wall current into the appropriate DC current and a DC jack is plugged into theinfusion device10 to keep theinfusion device10 powered whenever battery power is low or thebattery44 is removed. In additional embodiments, thebattery44 is rechargeable by supplying a DC current to theinfusion device10 such as by plugging in a DC converter. Alternatively, theinfusion device10 may be placed on a cradle to recharge thebattery44 using induction, solar cells, or use other methods of supplying current to a battery. In additional alternatives theinfusion device10 may be powered directly using solar cells, a DC power supply such as an exterior battery or a DC converter plugged into an AC outlet, and the like.
• In preferred embodiments, a switch89 (shown inFIGS. 4, 5 and10) is located in thehousing22 so that when thereservoir12 is inserted far enough into thehousing22, an end of thereservoir12 contacts theswitch89 causing theswitch89 to toggle. Theswitch89 is also spring loaded to return to its original position when thereservoir12 is removed. Thus, theswitch89 detects when thereservoir12 is removed from thehousing22. In alternative embodiments, theinfusion device10 may include an optical reader that optically detects when a reservoir is present. In preferred embodiments, when thereservoir12 is removed from thehousing22, the motor/gear box48 is automatically triggered to run in reverse to fully retract thepiston56 in preparation for anew reservoir12 to be installed. In alternative embodiments, the motor/gear box48 retracts thepiston56 when the key84 is removed far enough to permit removal of thereservoir12.
• In preferred embodiments, theinfusion device10 is disabled by theelectronics system16 when a predetermined usage life is expired. For instance, theelectronics system16 keeps track of the number of times thereservoir12 is replaced and compares that number to a specified number that is programmed into a software program in theelectronics system16. Thus, theelectronics system16 will shut down theinfusion device10, stopping the flow of fluid, after thereservoir12 is replaced a specified number of times. In preferred embodiments, the predetermined life of theinfusion device10 is expired when thereservoir12 has been replaced sixty times. In alternative embodiments, the number of times that thereservoir12 may be replaced before the predetermined life of theinfusion device10 is expired may be as many as one hundred and fifty times or as few as twenty times due to the durability of the components that might wear, how carefully individuals handle theinfusion device10, the types of climates theinfusion device10 is subjected to, or the like. In additional alternative embodiments, other measurements are used to detect when the infusion device's predetermined life is expired such as, the number of days of use, the number of times thebattery44 is replaced, an increase in the amount of battery power consumed to empty areservoir12, the number of times a key84 is removed from theinfusion device10, or the like.
• In preferred embodiments, theinfusion device10 may be refurbished and returned to the user to be used again after theelectronics system16 has disabled theinfusion device10 due to exceeding its predetermined life. In particular embodiments, theinfusion device10 can be refurbished at least once before its total life is expired. In particular embodiments, the predetermined life may increase or decrease after refurbishing due to a change in the quality of a replacement part, a new lubrication method, new information about the durability of theinfusion device10, how well the user cares for the particular infusion device, or the like. In alternative embodiments, theinfusion device10 is not refurbishable. In other alternative embodiments, theinfusion device10 may be refurbished at least 2 times and up to an indefinite number of times before its total life is expired and it can no longer be used. In particular embodiments, measurements are taken to determine if the total life of theinfusion device10 has expired such as, a significant physical shock detected by an accelerometer (perhaps a shock greater than 2.5 gs, depending on the amount of shock theinfusion device10 can handle), an increase in the amount of battery power consumed to empty areservoir12, a maximum temperature such as 120 degrees F. has been exceeded, the reservoir has been replaced too many times (such as 1,000 times), or the like.
• In preferred embodiments, theelectronics system16 stores the control parameters, and default control parameters are programmed into theelectronics system16 during manufacturing. Preferably, the control parameters may be changed by an individual using thecontrol system18. In preferred embodiments, thecontrol system18 of theinfusion device10 hasbuttons42 accessible through thehousing22. In particular embodiments, abutton42 is used to command a bolus. In other particular embodiments,additional buttons42 may provide additional control features such as to undo a previous command, confirm a command, activate a function, initialize a software program, initialize anew reservoir12, reset one or more control parameters to a default value, modify a control parameter, withdraw thepiston56, or the like. In preferred embodiments, LEDs indicate that control parameters have been modified by turning on or off, flashing, changing color, sequencing, or the like. In alternative embodiments, the electronics system includes a LCD, LED display, or other displays to show the status of control parameters and/or indicate to the user, which control parameters, are being modified. In other alternative embodiments, other feedback methods such as sounds, vibrations, or the like are used to indicate the status of control parameters.
• In other embodiments, asupplemental device90 is used as, or is used in addition to, thecontrol system18 to adjust, change, modify, program, input, or the like, one or all of the control parameters. Thesupplemental device90 interfaces with theelectronics system16 as shown inFIG. 1. Preferably, thesupplemental device90 includes adisplay98, aninput system100 and acommunication system102 that interfaces with theinfusion device10. Thecommunication system102 provides an initiating signal to theinfusion device10 to cause thecontrol system18 to go into a programming mode. Alternatively, no initiating signal is needed. Preferably thecommunication system102 provides 2-way communication between thesupplemental device90 and theinfusion device10, as shown inFIG. 1. Alternatively thecommunication system102 may be one way.
• In particular embodiments, thesupplemental device90 is acomputer system200 that communicates with aninfusion device210. Thecomputer system200 has amonitor202 as the display, akeyboard204 as the input system, and thecomputer206 andwires208 as the communication system, as shown inFIG. 11. In preferred embodiments, thewires208 are detachable at theinfusion device210. In alternative embodiments, thewires503 carry information between thesupplemental device90 to acommunication key501, shown in FIGS.19(a) and19(b). Thewires503 connect to thecommunication key501 through aconnector505 that mates withslot507 in the key501. Thecommunication key501 carries the information signals through electrical traces (not shown) toelectrical terminals114 on the infusion device, such as shown inFIG. 9. In particular embodiments, thewires503 are detachable from thecommunication key501 as shown in FIGS.19(a) and19(b). In other embodiments, thewires503 do not detach from the communication key. In further embodiments, thesupplemental device90 is a personal digital assistant (PDA)300 or a hand held computer such as a Palm Pilot that communicates with aninfusion device310. ThePDA300 has atouch screen LCD302 that performs the duties of both the display and the input system, while thecradle304 andwire306 serve as the communication system, as shown inFIG. 12. In still further embodiments, the PDA may communicate using a wireless connection, such as by IR, RF, or the like. In still other embodiments, thesupplemental device90 is adedicated programming device400, that communicates with aninfusion device410 as shown inFIG. 13. Thededicated programming device400 has aLCD402 for its display,buttons404 as the input system and aradio transmitter406 andreceiver408 as the communication system.
• In alternative embodiments, thecommunication system102 in thesupplemental device90 uses JR signals, optical signals, direct electrical contact, laser signals, combinations of carrier frequencies, or the like. In further alternative embodiments, thedisplay98 is monitor, a touch screen, LEDs, lights, or the like. In more alternative embodiments, theinput system100 includes a keyboard, a button, a touch screen, a touch pad, a dial, a switch, a microphone, a joystick, a computer mouse, a roller ball, or the like.
• In particular alternative embodiments, a communication key is used that includes portions of the communication system. For example, acommunication key601 has aradio frequency transmitter603 andreceiver605, shown inFIG. 20. Alternatively, acommunication key701 has a infrared transmitter703 andreceiver705, shown inFIG. 21. Other communication devices may be included in the communication key that use other carriers such as, ultrasonic, visual light, video frequencies, ultra violet, laser, microwave, or the like. In alternative embodiments, installation of the communication key into the infusion device causes the control system of the infusion device to go into a programming mode. In particular alternative embodiments, the infusion device enters a programming mode when the communication key contacts a switch (not shown), contactselectrical terminals114, is detected by a sensor such as an optical or magnetic proximity sensor, pushes a button, or the like.
• In another embodiment, control parameters such as the basal and/or bolus levels, maximum or minimum basal rate or the like, are set in aninfusion device103 when atab104, with at least oneconductive trace108, is inserted into aslot106 on thehousing107, such as shown inFIG. 14. Theconductive trace108 establishes connections between some of the electrical terminals (not shown) in theinfusion device103. Different patterns ofconductive traces108 and108′ ondifferent tabs104 and104′ (shown as examples inFIG. 15) connect different electrical terminals (not shown) in theinfusion device103. As different electric terminals (not shown) are connected to each other, different control parameters, such as basal rates, are set and then used by theelectronics system16. The number of electrical terminals (not shown) and the number ofconductive traces108 may vary depending on the number of control parameters that are controlled using thetabs104. The number of different patterns of uniqueconductive traces108, and thereforedifferent tabs104, is dependent on the number of control parameters that are controlled with thetabs104 and the number of variations needed for each command parameter. As an example of anapplication using tabs104 to control theinfusion device103, a doctor may prescribe a particular basal rate and therefore insert aparticular tab104 into theinfusion device103. Later, if a patient's needs have changed, the doctor may remove the originally prescribedtab104 and insert adifferent tab104 that causes theinfusion device103 to dispense the fluid at a different rate. In alternative embodiments, the tabs may include an optical pattern that is read by an optical reader in the housing. For instance, the optical pattern may be similar to that shown inFIG. 15. Alternatively, other patterns or a bar codes may be used. In further alternative embodiments, the tabs may include information stored on a magnetic media. And the information may be read by a magnetic reader contained within the housing.
• In alternative embodiments, the tab is in the form of a tab/key110 that slides intoslot83 on aninfusion device111 to hold thebattery44 and/orreservoir12 in place as shown inFIG. 9. Conductive traces112 on the tab/key110 establish connections between some ofelectrical terminals114. Different patterns ofconductive traces112 and112′ on different tab/keys110 and110′ (shown as examples inFIG. 16) connect differentelectrical terminals114. Again, as differentelectrical terminals114 are connected to each other, different control parameters such as basal rates, or the like, are set and used by theelectronics system16.
• In other embodiments, atab116 has aprogrammable chip118, such as shown inFIG. 17, which is programmed with different control parameters before insertion into aslot122 in ahousing124 of aninfusion device126. One or moreconductive traces120 on thetab116 connect thechip118 to theelectronics system16 through electrical terminals (not shown) in thehousing124. In particular embodiments,different tabs116 havechips118 that are programmed with different basal rates. Therefore, to change the basal rate for aninfusion device10, an individual may remove the existingtab116 from thehousing124 and install adifferent tab116 that includes achip118 that is programmed to command a different basal rate. In particular embodiments, thetabs116 are removed from theinfusion device126, and thechips118 are re-programmed with different control parameters, and then thetab116 is re-installed into theinfusion device126. In alternative embodiments, thechips118 are not re-programmable, and anew tab116 with anew chip118 is used when control parameters must be changed.
• In alternative embodiments, the tab is in the form of a tab/key128 and has aprogrammable chip130 such as shown inFIG. 18, which is programmed with different control parameters before insertion intoslot83 of thehousing22 ofinfusion device132. One or moreconductive traces134 on the tab/key128 connect thechip130 to theelectronics system16 throughelectrical terminals114.
• In additional alternative embodiments, a tab/key, normally used to establish control parameters as described above, may be a communication key. The communication key enables the infusion device to communicate with asupplemental device90 to change control parameters or transfer data. In particular embodiments, a tab/key that is not a communication key is reinserted into the infusion device for normal operation after the communication key has completed the communication with thesupplemental device90. In other particular embodiments, the communication key is left in the infusion device or a different tab/key is used after the communication device is removed.
• In other particular embodiments, the tab/key includes communication devices. For example, a tab/key with a computer chip (such as tab/key128 described above) may include a slot to accept a connector such ascommunication key501 shown in FIGS.19(a) and19(b). Other communication devices such as IR, RF, ultrasonic, or the like may be included on a tab/key. In particular embodiments, thesupplemental device90 can reprogram computer chips included on the tab/key. In alternative embodiments, a communication device is included on a tab that does not serve as the key that covers thebattery44 and thereservoir12.
• In preferred embodiments, the tabs are color coded to identify the basal rate or other control parameters they are programmed to command. In alternative embodiments, other identification methods may be used to indicate the basal rate, and/or other control parameters, associated with a particular tab such as, a code number, a serial number, a lot number, a batch number, a name, or the like. Methods of applying the identification include, stamping, silk-screening, printing, typing, labels, embossing, imprinting, molding, or the like. In additional alternative embodiments, other means are used to identify tabs that have different control parameters from each other such as, surface textures, flexibility, materials, a raised patterns, printed patterns, or the like.
• Tabs may be used to modify characteristics of other infusion devices as well, such as those described in U.S. Pat. Nos. 4,562,751; 4,685,903; 5,080,653; 5,505,709; 5,785,688; 5,814,020 and 5,097,122; and disclosed in U.S. patent application Ser. No. 09/334,858 (attorney docket PD-0294), filed Jun. 17, 1999 and entitled “Infusion Pump With Remote Programming and Carbohydrate Calculator Capabilities”, and Ser. No. 09/429,352 (attorney docket PD-0286), filed Oct. 28, 1999 and entitled “Compact Pump Drive System”, which are hereby incorporated by reference. In particular embodiments, tabs are used in disposable infusion devices, such as shown in FIGS.23(a)-24(b) and U.S. Pat. Nos. 5,814,020 and 5,785,688. Theinfusion device800, shown in FIGS.23(a) and (b), has ahousing818, areservoir812, agas generator814, one ormore batteries816, and atab802 that contains one or more electronic elements (not shown). When thetab802 is installed into anopening804 on theinfusion device800, one or moreconductive traces806 come in contact with one or moreelectrical terminals808 to provide an electrical contact between theinfusion device800 and thetab802. Aseal810 closes theopening804 in theinfusion device800 to prevent contaminants from entering and/or to improve water resistance of theinfusion device800.
• In other embodiments, one ormore batteries916 are stored in atab902 that mates with aninfusion device900, such as shown in FIGS.24(a) and (b). Theinfusion device900 has ahousing918, areservoir912, agas generator914, and anopening904 to receive thetab902. Thetab902 contains the one ormore batteries906 and one or more electronic elements (not shown). When thetab902 is inserted into theopening904 one or moreconductive traces906 come into electrical contact with one or moreelectrical terminals908 on theinfusion device900. Aseal910 closes theopening904 in theinfusion device900 to prevent contaminates from entering and/or to improve water resistance of theinfusion device900.
• In still other embodiments, one or more components that are included with the tab are reusable and/or sensitive to sterilization treatments such as, radiation, heat, gas, fog or mist (such as hydrogen peroxide), chemical washes or soaks, and the like. The infusion device without the tab can be processed through a sterilization process before the tab is inserted. Thus, the tab, and any components included with the tab, are excluded from a sterilization process, since these components do not come in contact with fluids or materials infused into the body and do not need to be sterilized.
• In some embodiments, the tab may be used in one infusion device, and then removed from the infusion device and installed into another infusion device. For example, a tab may be mated with an infusion device that has been sterilized, and then the infusion device is used for infusing a fluid into an individual. When the infusion device is ready to be replaced due to, for example, a low reservoir, housing damage, or for any other reason, the tab may be removed. Once the tab is removed, the infusion device may be disposed of or re-sterilized. The tab may be reused with a new infusion device or a newly sterilized infusion device, or the tab may be disposed of when no longer useable.
• In preferred embodiments, the tab must be inserted into the infusion device for the infusion device to operate. And removal of the tab causes the infusion device to stop fluid delivery. In alternative embodiments, the infusion device continues to operate independent of whether a tab is installed or not.
• In preferred embodiments, an LED (light emitting diode) or other indicator may be used on the infusion device or on the tab to indicate that the tab is inserted properly, the drive system is powered, fluid delivery is in process, the power supply status, and the like.
• In preferred embodiments, the tab may include, for example, portions of, or all of: an electronics system, drive system, power supply, communication system, output device (such as an LCD, one or more LED's, speaker, sound making device, vibrator, and the like), input devices (such as a key pad, a touch screen, or the like), or the like.
• In a particular embodiment, one ormore batteries1016, anelectronics system1018, and adrive system1014 are included in atab1002 that mates with aninfusion device1000, such as shown in FIGS.25(a) and (b). Theinfusion device1000 has ahousing1018, areservoir1012, and anopening1004 to receive thetab1002. When thetab1002 is inserted into theopening1004, one or moreconductive traces1006 come into electrical contact with one or moreelectrical terminals1008 on theinfusion device1000. Aseal1010 closes theopening1004 in theinfusion device1000 to prevent contaminates from entering and/or to improve water resistance of theinfusion device1000. In alternative embodiments, some of theelements1016,1018, or1014 may be omitted entirely.
• In alternative embodiments, a tab may be shaped to attach to the external surface of the infusion device. In other embodiments, the tabs may be formed in different shapes and the seals may be omitted, placed in a different position on the tab, or placed on or incorporated in the infusion device.
• In some embodiments, the tabs are coded so that tabs with different characteristics (such as electrical elements that cause a different infusion rate, or work with different types of insulin, or add or subtract features, or affect different control parameters) may be identified from one another. For example, the tabs may be different colors, have bar codes or markings, include numbers, letters and/or names, have bumps, be different shapes, have textures or patterns, or the like.
• In other embodiments, the tabs may affect the infusion device filling process. In some embodiments, the tab must be installed into the infusion device before the infusion device reservoir is filled with medicament. For instance the tab may activate a valve to open the fluid path, or the tab may include a port for a filling apparatus to mate with the infusion device, of the shape of the tab may limit the shape of the filling apparatus that can be mated with the infusion device to fill the reservoir with medicament, or the like. In these embodiments, different concentrations or different types of medicament may be packaged in different filling apparatuses so that each type of tab will only permit a particular filling apparatus to mate with the infusion device, if the filling apparatus contains medicament that is compatible with the tab. In alternative embodiments, the tab may provide a code or signal to the infusion device indicating which filling apparatuses are compatible with the tab. Alternatively, each filling apparatus may provide a code or signal to the infusion device. If the filling apparatus is not compatible with the tab, the filling apparatus cannot connect with the infusion device and/or the fluid path to the reservoir is not opened to permit filling. Conversely, if the filling apparatus is compatible with the tab, it will connect with the infusion device and the fluid path to the reservoir is opened to permit filling.
• In other embodiments, each tab has a limited usage life. In particular embodiments, the tab is removable from the infusion device and may be installed into a different infusion device to affect at least one control parameter of the infusion device. In some embodiments, the tab may only be re-installed into a different infusion device a predetermined number of times, which determines the usage life. Once the usage life is exceeded, the tab will not permit the infusion device to function. In other embodiments, the tab will work for a limited amount of time or until a predetermined amount of medicament is expelled from the infusion device reservoir, or until the reservoir has been emptied a predetermined number of times, or the like.
• Tabs may also be used to calibrate or control various features of characteristic or analyte monitor systems such as those described in U.S. patent application Ser. No. 09/465,715 (attorney docket PD-0291), filed Dec. 17, 1999 and entitled “Telemetered Characteristic Monitor System And Method Of Using The Same”; and Ser. No. 09/246,661 (attorney docket PD-0321), filed Feb. 5, 1999 and entitled “An Analyte Sensor And Holter-Type Monitor System And Method Of Using The Same”; and also Ser. No. 09/334,996 (attorney docket PD-0338), filed Jun. 17, 1999 and entitled “Characteristic Monitor With A Characteristic Meter And Method Of Using The Same”, which are all hereby incorporated by reference herein.
• In preferred embodiments, substantially all parts of theinfusion device10 are designed to slide or snap together during assembly. In particular embodiments, no screws are used on theinfusion device10. In preferred embodiments, thehousing22 is plastic and is sealed using ultrasonic fusing. In alternative embodiments, other methods are used to seal thehousing22 such as gluing, bonding, fusing, melting, snapping, pressing, or the like. In other alternative embodiments, thehousing22 is made of other materials such as metal, rubber, resin, foam, or the like. Refurbishing of theinfusion pump10 may require destruction of thehousing22.
• While the description above refers to particular embodiments of the present invention, it will be understood that many modifications may be made without departing from the spirit thereof. The accompanying claims are intended to cover such modifications as would fall within the true scope and spirit of the present invention.
• The presently disclosed embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims, rather than the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.

Claims (24)

1-41. (canceled)

42. An external infusion system for infusing a fluid into a body, the infusion system comprising:

an external infusion device comprising:

a housing adapted for use on an exterior of the body;

a reservoir contained in the housing for containing the fluid before infusing;

a drive system for delivering the fluid from the reservoir into the body; and

an electronics system coupled to the drive system that uses a plurality of control parameters to regulate the drive system to deliver the fluid from the reservoir into the body;

wherein the infusion device has a predetermined usage life, and when the predetermined usage life for the infusion device expires, the infusion device ceases to deliver the fluid from the reservoir into the body; and

a supplemental device comprising:

an input device for inputting data to adjust at least one of the control parameters of the infusion device;

a display coupled to the input device for displaying the at least one of the control parameters of the infusion device; and

a communication system coupled to the input device and the display that interfaces with the electronics system of the infusion device to adjust the at least one of the control parameters of the infusion device.

43. The infusion system ofclaim 42, wherein the predetermined usage life for the infusion device is programmed into the electronics system as a number of days the infusion device is in use.

44. The infusion system ofclaim 42, wherein the predetermined usage life for the infusion device is programmed into the electronics system as a number of times the reservoir is replaced in the infusion device.

45. The infusion system ofclaim 42, wherein the infusion device further comprises a power supply coupled to the drive system and the electronics system for providing power to the drive system and the electronics system.

46. The infusion system ofclaim 45, wherein the power supply of the infusion device is a battery, and the predetermined usage life for the infusion device is programmed into the electronics system as a number of times the battery is replaced in the infusion device.

47. The infusion system ofclaim 42, wherein the drive system of the infusion device comprises a shape memory alloy driven motor.

48. The infusion system ofclaim 42, wherein the drive system of the infusion device comprises a DC motor.

49. The infusion system ofclaim 42, wherein the supplemental device communicates with the infusion device using a wireless connection.

50. The infusion system ofclaim 49, wherein the supplemental device communicates with the infusion device using RF frequencies.

51. The infusion device ofclaim 42, wherein the infusion device further comprises an alarm that is activated when the predetermined usage life for the infusion device expires.

52. The infusion system ofclaim 42, wherein the communication system of the supplemental device further interfaces with the electronics system of the infusion device to receive data from the infusion device.

53. The infusion system ofclaim 52, wherein the display of the supplemental device further displays the data received from the infusion device.

54. The infusion system ofclaim 52, wherein the supplemental device further comprises an alarm that is activated when the communication system receives data from the infusion device indicating that the predetermined usage life for the infusion device has expired.

55. The infusion system ofclaim 42, wherein the fluid to be infused into the body is insulin.

56. The infusion system ofclaim 55, wherein the at least one of the control parameters of the infusion device adjusted by the supplemental device is a basal rate of the insulin to be infused into the body.

57. The infusion system ofclaim 55, wherein the at least one of the control parameters of the infusion device adjusted by the supplemental device is a bolus of the insulin to be infused into the body.

58. An external infusion device for infusing a fluid into a body, the infusion device comprising:

a housing adapted for use on an exterior of the body;

a reservoir contained in the housing for containing the fluid before infusing;

a drive system including a shape memory alloy driven motor for delivering the fluid from the reservoir into the body; and

an electronics system coupled to the drive system that uses a plurality of control parameters to regulate the drive system to deliver the fluid from the reservoir into the body and that is adapted to interface with a supplemental device to adjust at least one of the control parameters of the infusion device;

wherein the infusion device has a predetermined usage life that is programmed into the electronics system as a number of days the infusion device is in use.

59. The infusion device ofclaim 58, wherein when the predetermined usage life for the infusion device expires, the infusion device ceases to deliver the fluid from the reservoir into the body.

60. The infusion device ofclaim 58, wherein the electronics system is adapted to interface with the supplemental device using a wireless connection.

61. The infusion device ofclaim 60, wherein the electronics system is adapted to interface with the supplemental device using RF frequencies.

62. The infusion device ofclaim 58, wherein the fluid to be infused into the body is insulin.

63. The infusion device ofclaim 62, wherein the at least one of the control parameters of the infusion device adjusted by the supplemental device is a basal rate of the insulin to be infused into the body.

64. The infusion device ofclaim 62, wherein the at least one of the control parameters of the infusion device adjusted by the supplemental device is a bolus of the insulin to be infused into the body.

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