Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
  • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
  • A61M5/16831—Monitoring, detecting, signalling or eliminating infusion flow anomalies
  • A61M5/16854—Monitoring, detecting, signalling or eliminating infusion flow anomalies by monitoring line pressure
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
  • A61M5/142—Pressure infusion, e.g. using pumps
  • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
  • A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
  • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
  • A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
  • A61M5/1723—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic using feedback of body parameters, e.g. blood-sugar, pressure
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
  • A61M2005/1401—Functional features
  • A61M2005/1405—Patient controlled analgesia [PCA]
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/18—General characteristics of the apparatus with alarm
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/35—Communication
  • A61M2205/3546—Range
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/35—Communication
  • A61M2205/3576—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M2230/00—Measuring parameters of the user
  • A61M2230/20—Blood composition characteristics
  • A61M2230/201—Glucose concentration
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/18—Applying electric currents by contact electrodes
  • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
  • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
  • A61N1/36003—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of motor muscles, e.g. for walking assistance
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/18—Applying electric currents by contact electrodes
  • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
  • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
  • A61N1/36014—External stimulators, e.g. with patch electrodes
  • A61N1/3603—Control systems
  • A61N1/36031—Control systems using physiological parameters for adjustment

Definitions

• the present invention relates to a signal device for conveniently providing a user with information.
• the signal device of the invention is suitable for use in combination with drug deliv- ery devices or systems, the signal providing information in the form of a signal or an alarm in respect of a process or an action controlled by, or a state monitored by, a drug delivery device or system.
• Diabetes mellitus is the common name for at least 2 different diseases, one characterised by immune system mediated specific pancreatic beta cell destruction (insulin dependent diabetes mellitus (IDDM) or type 1 diabetes), and another characterised by decreased insulin sensitivity (insulin resistance) and/or a functional defect in beta cell function (non-insulin dependent diabetes mellitus (NIDDM) or type 2 diabetes).
• IDDM immune system mediated specific pancreatic beta cell destruction
• insulin resistance insulin sensitivity
• NIDDM non-insulin dependent diabetes mellitus
• type 1 diabetes The principal treatment of type 1 diabetes is straight forward substitution of the missing insulin secretion, whereas treatment of type 2 is more complicated. More specifically, in early stages of type 2 diabetes treatment a number of different types of drugs can be used, e.g. drugs which increase insulin sensitivity (ciglitazones), decrease hepatic glucose output (e.g. metformin), or reduce glucose uptake from the gut (alfa glucosidase inhibitors), as well as drugs which stimulate beta cell activity (e.g. sulfonylurea/meglitinides).
• beta cell stimulators will eventually fail to stimulate the cell, and the patient has to be treated with insulin, either as mono therapy, or in combination with oral medication in order to improve glucose control.
• an infusion pump may provide fully automatic closed loop control of insulin infusion.
• infusion pumps which may either be fully disposable providing only the most basic functions such as a constant basal rate, or infusion pump systems comprising a disposable portion in combination with a durable control portion, where the latter may provide many of the more advanced features of the traditional pump.
• US patent 4,559,037 discloses a control device for wireless transmission of program instructions to an insulin pump unit which may be either implanted or external to the body.
• the control device may be used to select a desired basal rate, to select a given infusion schedule or to command the infusion of a bolus having a desired size and infusion profile.
• the disclosed control device may be programmable and may comprise a display.
• WO 00/10628 discloses a similar system in which a remote commander can be used to selectively activate a desired function in an external infusion pump device, e.g. delivery of a bolus, selecting a profile for the bolus, or selecting a basal infusion rate.
• the remote commander comprises a display allowing the user to visually confirm the values entered into the remote commander.
• an infusion pump adapted for or suitable for being carried under the clothing of a user can carry out a large number of actions, e.g. providing pre-programmed infusion rates or profiles, providing user actuated bolus infusions, or providing feed-back controlled closed loop infusion of a desired drug.
• most infusion pumps are provided with control means for controlling or checking a number of "internal" conditions of the infusion pump, e.g. flow control means checking that the infused amount of drug corresponds to the set amount, the amount of drug in the reservoir, a low power condition or any other type of malfunction.
• infusion pumps For all these types of actions or conditions, it would be desirable to communicate information in respect thereof to the user.
• most infusion pumps (especially the more complex of the durable type) is provided with a display capable of displaying all relevant information, e.g. present settings, received instructions, performed user actuated actions, or any type of a variety of alarms.
• this type of infusion pump is preferably worn under the clothing which makes it difficult or inconvenient to check any in- formation displayed directly by the infusion pump.
• a basic solution to the problem would be to provide an audible signal or alarm means, e.g. a "beeper" as widely utilized in electronically controlled devices to indicate a given condition.
• a "beeper” as widely utilized in electronically controlled devices to indicate a given condition.
• WO 00/10628 discloses a remotely controllable infusion pump device which uses an audible signal to indicate that a given instruction has been received and subsequently that it has been performed.
• WO 00/10628 also discloses that a vibratory means can be used in an infusion pump to indicate a signal or alarm.
• a vibratory means may also be utilized to provide further functions such as generating sufficient vibration to assist in removing gas bubbles from the drug in the reservoir during priming procedures or to agitate the drug in the reservoir in between successive delivery periods.
• to provide such a vibratory alarm is relatively expensive as it normally will have to be implemented as a motor driven imbalance, i.e. as often used in mobile phones, just as it is relatively bulky.
• an object of the present invention to provide an easy to use and easy to apply signaling means which effectively but discreetly can be used to provide a user with a signal indicative of a given situation, e.g. corresponding to an action controlled or a state monitored by a medical therapy device such as an infusion pump or sensor device, yet can be provided in a cost-effective manner.
• the present invention is based on the concept that the desired signal function can be based on external electro-muscle stimulation (EMS) in which a conductive pad or electrode is applied externally to the body of a user such that a very weak current can be applied to a muscle or group of muscles to thereby cause them to contract to a degree which is recognisable by the user.
• EMS external electro-muscle stimulation
• Electro-muscle stimulation per se is well known in the medical art and is commonly used in physical or occupational therapy to strengthen atrophied muscles or paralyzed limbs, and also to exercise muscles that are immobilized for long periods of time as a result of mus- cular or neurological disorders, extended periods of bed rest arising from injury, surgery, or illness.
• EMS is also useful for the general exercise of functional muscles to improve muscle tone and strength. For example with athletes, EMS can be used to treat muscle injuries as a supplement to conventional conditioning exercises. EMS can also be used to recondition muscles or muscle groups which have, for whatever reason, lost their tone and/or strength, have been injured, or are in need of reconditioning to effect cosmetic improvements.
• the sole purpose of the present invention is to provide a signal which is recognizable by the user, no therapeutic effect on the involved muscles being intended.
• a fluid (e.g. drug) delivery device comprising a reservoir adapted to contain a liquid drug and comprising, in a situation of use, associated outlet means, as well as expelling means for expelling a drug out of the reservoir through the outlet means.
• the device further comprises a voltage and energy source and a pair of electrodes adapted to be mounted in conductive contact with the skin of a subject, wherein the control means is adapted for identifying a predefined condition and applying a voltage between the pair of electrodes in response thereto, the flow of current between the pair of electrodes, in a situation of use, resulting in a tactile muscle stimulation.
• the outlet means associated with the reservoir may be in direct fluid communication with the reservoir (e.g. in case the expelling means is arranged "before” the reservoir as for a piston pump) or indirect fluid communication (e.g. in case the expelling means is arranged “after” the reservoir as for a membrane pump).
• the outlet means may be adapted to be brought in fluid communication with infusion means (e.g. a catheter tubing or transcutaneous access means such as an infusion needle, a flexible infusion cannula or a plurality of micro- penetrators) or may comprise these. In the latter case the fluid communication may be established just prior to use, before or after the drug delivery device has been arranged on the user.
• the fluid delivery device may be intended to be fully disposable, partially disposable (i.e. with the different components of the device arranged in either a disposable or a durable portion) or durable, it may be prefilled just as it may provide constant rate infusion only or also bolus delivery.
• the expelling means may be of any desirable nature, such as known from US patents 4,340,048 and 4,552,561 (based on osmotic pumps), US patent 5,858,001 (based on a piston pump), US patent 6,280,148 (based on a membrane pump), US patent 5,957,895 (based on a flow restrictor pump (also know as a bleeding hole pump)), or US patent 5,527,288 (based on a gas generating pump), which all in the last decades have been proposed for use in inexpensive, primarily disposable drug infusion pumps, the cited documents being incorporated by reference.
• the nature of the predefined conditions may be chosen in accordance with the circumstances, e.g. in accordance with the actual configuration of the device (e.g. more or less complex) and the intended use (e.g. providing more or less information).
• the intended use e.g. providing more or less information.
• alarm signals indicative of a "primary" mal- function situation such as when the actual flow rate differs from a preset flow rate, e.g. in case of relative or absolute obstruction of the flow of drug.
• a pressure sensor may be used to determine if the pressure in the reservoir, expelling means or associated outlet means is above a preset level indicative of blocking.
• the means for detecting a given predefined condition may be provided integrally with means controlling the expelling means or they may be provided as additional control means.
• values such as the amount of drug remaining in the reservoir may be calculated on the basis of the infusion rate and the initial amount of drug in the reservoir.
• such independent detecting means may be in the form of flow sensors or pressure sensors.
• Further types of alarms may signal a low power situation or improper operation of the elec- trodes.
• the flow of current between the (main) pair of electrodes may be outside a preset range indicating either poor contact or a short circuit. Indeed, in case of very poor contact this information would not be communicated to the user, however, to provide a remedy to this situation it may be desirable to provide information as to the correct operation of the device, e.g. an hourly signal indicating that all monitored conditions are OK.
• the device may be provided with two or more electrodes which would be operated by the control means in accordance with the given circumstances to provide the intended signal.
• the drug delivery device is adapted to receive remotely gener- ated commands and to control the drug delivery device in accordance therewith, typically when a user-operated remote control device is used to transmit commands to the drug delivery device.
• the muscle stimulating electrodes may be activated to provide a signal indicative thereof. This signal may be more or less specific, e.g. it may simply indicate that a command has been received, it may indicate that a command from one or more predefined groups of commands has been received, it may indicate that a specific command has been received or, most specifically, the exact nature of a specific command. For example, it may be indicated that a bolus command has been received and subsequently the size (e.g.
• the number of IU may be indicated by a corresponding number of current pulses.
• a predefined control action may be performed in response to a received command, e.g. a bolus infusion.
• the nature of the signals transmitted to the musculature may be chosen in accordance with the intended use and the desired level of sophistication and complexity for the drug delivery device and/or the signal and alarm means.
• the drug delivery device may be provided merely with an occlusion alarm which provides a stimulating alarm signal having predetermined characteristics in respect of amplitude, polarity, frequency, waveform etc.
• a stimulating alarm signal having predetermined characteristics in respect of amplitude, polarity, frequency, waveform etc.
• one type of signal is intended to provide all users with the desired information.
• the stimulation characteristics could be adapted to suit the actual conditions, i.e. when placed in a given location on a given user.
• the drug delivery device may advantageously be provided with means allowing the stimulation intensity (or any other stimulation characteristics) to be set by the user.
• These means may be in the form of user-accessible means accessible directly on the device (e.g. one or more buttons), however, in exemplary embodiments the control means are adapted to receive corresponding commands from external remote control means.
• the corresponding signal may have different pre-set or user- selectable characteristics.
• An alarm may start out at a low level and escalate until acknowledged by the user, however, this would require that the user in such situations would have to manually stop the alarm signal.
• the characteristics of the muscle stimulation signals should be chosen to provide a signifi- cant yet pleasant amount of muscle stimulation, e.g. a tickling feel, just as in case different stimulation patterns are used it should be possible to clearly identify the different patterns.
• the actual voltage supplied between the electrodes which will ensure the above, will vary in accordance with a number of factors such as individual preferences, adiposity of the user and location of placement. This said, the applied voltage will typically be less than 40V and more typically in the range 3-15V.
• the drug delivery device comprises a mounting surface adapted for application directly to the skin of the user, the pair of electrodes being arranged on the mounting surface which advantageously comprises adhesive means (e.g. a pressure- sensitive adhesive) which allows the device to be affixed to the skin of the subject user.
• the electrodes may be of any given type or configuration providing the desired electrical contact under the relevant conditions of use.
• the electrodes may be of the type described in US patent 4,522,211 which discloses a surface member defining a well or cham- ber in which is disposed a porous or reticulated matrix, such as may be provided by a sponge-like plastic-like material, the porous matrix, or "gel pad” as it is often termed, being impregnated with a quantity of electrolytic gel.
• the chamber for each provided electrode is advantageously surrounded by adhesive portions of the mounting surface and provided with an easily removable cover arrangement (e.g. a peelable liner) overly- ing the adhesive and the gel pads to prevent deterioration and leakage of the gel during storage.
• an easily removable cover arrangement e.g. a peelable liner
• the specific arrangement, size and configuration of the electrodes will depend on the actual configuration and intended use of the device.
• the present invention provides a sensor device comprising a sensor ele- ment adapted to be inserted transcutaneously through the skin of a subject and capable of being influenced by a body substance, thereby producing a signal corresponding to a parameter thereof, as well as control means adapted to receive signals from the sensor means and generate command signals in response thereto.
• the sensor device further comprises a voltage and energy source, and a pair of electrodes adapted to be mounted in conductive contact with the skin of a subject, wherein the control means is adapted for identifying a predefined condition on the basis of the command signals and applying a voltage between the pair of electrodes in response thereto, the flow of current between the pair of electrodes, in a situation of use, resulting in muscle stimulation.
• the command signals are in the form of a value indicative of a blood glucose level of the subject.
• an alarm signal may be provided when a measured a blood glucose level which is above or below a given range.
• Further signals may indicate malfunction of a subcutaneously arranged sensor element, that a low voltage condition for the voltage source has occurred or that it is time to change the sensor ele- ment.
• relatively small and flexible electrochemical sensors have been developed for subcutaneous placement of sensor electrodes in direct contact with patient blood or other extra-cellular fluid (see for example US patent 5,482,473), wherein such sensors can be used to obtain periodic or continuous readings over a period of time. This type of sensors are described in, among others, US patents 5,390,671 , 5,391 ,950, 5,568,806 and 5,954,643 which hereby are incorporated by reference.
• a system comprising a sen- sor portion as well as drug infusion portion, at least one of the portions being provided with muscle stimulating signal means as described above.
• the system may be in the form of a closed loop system adapted for controlling the blood glucose concentration in the body of a patient, comprising sensor means having a sensor system adapted for providing a sensor signal indicative of a glucose level in blood, the sensor system comprising a sensor element, control means adapted to receive the signals from the sensor system and generate command signals in response thereto in order to keep the blood glucose level of the patient within a desired range, and delivery means for delivering an amount of at least one drug having a blood glucose regulating effect, wherein operation of the delivery means is affected by the command signals.
• a value indicative of a level of a body fluid parameter is determined, and an effective amount of a drug having a regulating effect on that body fluid parameter is infused into the patient in response to the determined value in order to keep the body fluid parameter level of the patient within a desired range.
• the system may be provided as one or more individual units.
• a single, self-contained combined sensor and prefilled pump is provided adapted to be mounted on a skin-surface of a user.
• an individual sensor assembly and an individual drug infusion pump assembly is provided.
• the two assemblies may be adapted to be locked to each other and utilized as a single unit, or the two assemblies may be mounted on the skin of the user independently but in communication with each, e.g. by cordless communication means.
• cordless communication means When the system is provided in the form of separate sensor and pump assemblies, it would be possible to offer different types of sensor assemblies and different types of pump assemblies.
• a general-purpose signal device comprising a first electrode adapted to be mounted in conductive contact with the skin of a subject, a second electrode adapted to be mounted in conductive contact with the skin of a subject, the first and second electrodes providing a pair of electrodes, a voltage source for providing a voltage between the pair of electrodes, and control means for controlling the voltage applied between the pair of electrodes, the control means being adapted for identifying a predefined condition or signal and apply a voltage between the pair of electrodes in response thereto.
• Such a signal device may be incorporated into any skin-mountable device, or it may be provided as a separate skin-mountable signal unit adapted to be in communication with and/or controlled by one or more primary devices.
• the signal device When provided with means for receiving externally generated (cordless) command signals, the signal device may be used in combination with devices or systems which then do not have to be skin mounted.
• a signal device may be utilized with a separate infusion pump which may then be carried in a belt or in a pocket.
• Such an arrangement would provide the user with a choice of signal means, e.g. in some situations it would be acceptable to rely on an audible signal whereas in other situations it would be desirable to use the silent signal means of the present invention.
• the signal device may use the signal device as a hearing aid, e.g. to help hear the phone ring, an alarm clock sound or any other traditionally audible signal.
• the two devices will have to be adapted to communicate with each other.
• the sensor device and the general-purpose signal device in accordance with further aspects of the invention may be provided with a "simple" alarm or more advanced versions which can be adapted to suit the actual situation of use, just as for different types of stimulation signals, the corresponding signals may have different pre-set or user-selectable characteristics.
• the electrodes may be configured as described above with reference to the drug delivery device.
• drug is meant to encompass any drug-containing flowable medicine capable of being passed through a delivery means such as a hollow needle in a con- trolled manner, such as a liquid, solution, gel or fine suspension.
• a delivery means such as a hollow needle in a con- trolled manner, such as a liquid, solution, gel or fine suspension.
• Representative drugs in- elude pharmaceuticals such as peptides, proteins, and hormones, biologically derived or active agents, hormonal and gene based agents, nutritional formulas and other substances in both solid (dispensed) or liquid form.
• the term “subcutaneous” infusion is meant to encompass any method of transcutaneous delivery to a subject.
• fig. 1 is a schematic representation of a first embodiment of the invention
• fig. 2 is a schematic representation of a second embodiment of the invention.
• fig. 3 shows a third embodiment
• fig. 4 shows a fourth embodiment in a side view
• fig. 5 shows a view of the mounting surface of the fourth embodiment.
• FIGs. 1-5 show schematic representations of embodiments of the invention.
• the configuration of the different structures as well as there relative dimensions and positions are intended to serve illustrative purposes only.
• fig. 1 shows a drug infusion system 100 comprising a drug delivery device 101 and an optional remote control device 102.
• the drug delivery device comprises a drug reservoir 111 in fluid communication with a pump 112 (e.g. a membrane pump) adapted for infusing a drug into a body of a user via infusion needle 113 in accordance with instructions received from the control means in form of a micro processor 121.
• the pump may be of the metering type, i.e. the amount of drug infused corresponds to the controlling signals received from the processor or the infusion unit may be provided with detecting means for determining the amount of drug actually infused.
• a separate flow monitor and occlusion detector 122 is provided downstream of the pump in communication with the processor.
• a voltage and energy source 141 is provided in the form of a battery supplying energy to the processor as well as the pump and detecting means (via the processor).
• a typical voltage supplied by the battery would be 1.5 or 3V, however, to provide a muscle stimulating current it is necessary to transform the battery voltage to a higher level using e.g. a switch mode power supply (SMPS) 142 transforming the voltage to for example 20V.
• SMPS switch mode power supply
• the SMPS is shown as a separate element, it is preferably provided integrally with a processor unit.
• the drug delivery device further comprises a pair of electrodes 151 , 152 adapted to be mounted in conductive contact with the skin of a subject.
• the electrodes and the infusion needle are arranged on different sides of the device, however, for an actual implementation of the invention, the drug delivery device advantageously comprises a mounting surface adapted for application to the skin of a subject, the pair of electrodes as well as the infusion needle being arranged on the mounting surface. This consideration also applies to the second and third embodiments.
• the processor is programmed (being either pre-programmed or programmable) for identifying one or more predefined conditions and applying a voltage between the pair of electrodes in response thereto, such that the flow of current between the pair of electrodes will result in muscle stimulation when the electrodes are in conductive contact with the skin of the user. For example, an alarm may be initiated in case an occlusion is detected by the occlusion detector 122.
• the processor 121 is associated with a receiver 131 for receiving user-controllable command signals from a remote control device 102 comprising a corresponding transmitter 132.
• the remote device may be used to set the characteristics for the (alarm) signals transmitted via the electrodes as described in detail above, however, the remote device is preferably in the form of a general command unit by which the unit can control the drug delivery device, e.g. setting an infusion rate, program a bolus infusion of a desired size.
• the communication is preferably cordless based on e.g. RF or IR transmission.
• the first embodiment is based on one-way transmission of commands from the remote device to the drug delivery device, however, the transmission and receiving means may be adapted to also transmit information from the infusion to the remote device, e.g. the actual infusion rate or the remaining amount of drug in the reservoir, the remote device being provided with a display for displaying such information.
• Fig. 2 shows a schematic representation of a second embodiment of the invention, in which like numerals are used to identify like structures.
• the drug delivery device 201 of the second embodiment corresponds generally to the first embodiment, however, the reservoir and pump means are provided by a combined infusion unit 211 operating independently with regard to the control processor 221 merely providing a basal rate infusion of a drug.
• Such an infusion unit may be based on an osmotic pump, a bleeding hole pump or a gas generating pump.
• a separate flow monitor and occlusion detector 222 is provided downstream of the pump in communication with the processor.
• the second embodiment represents a simpler drug delivery device comprising no receiving means, however, means for programming the processor 221 may be provided on the drug delivery device (not shown).
• Fig. 3 shows a schematic representation of a third embodiment of the invention, in which like numerals are used to identify like structures.
• the third embodiment is in the form of a sensor device 301 comprising a needle-formed sensor 313 adapted to be inserted subcutaneously through the skin of a subject and capable of being influenced by a body substance and pro- ducing a signal corresponding thereto.
• a battery 341 for energizing the processor is provided, the processor comprising a SMPS to boost the voltage from the battery.
• the processor 321 is adapted to receive signals from the sensor means and generate command signals in response thereto.
• the command signals may be transmitted to an external device via transmission means 321 , for example to an infusion pump device of the type corresponding to the first embodiment.
• the system is in the form of a closed loop system adapted for controlling the blood glucose concentration in the body of a patient, comprising sensor means having a sensor system adapted for providing a sensor signal indicative of a glucose level in blood, the sensor system comprising a sensor element, control means adapted to receive the signals from the sensor system and generate command signals in response thereto in order to keep the blood glucose level of the patient within a desired range, and delivery means for delivering an amount of at least one drug having a blood glucose regulating effect, wherein operation of the delivery means is affected by the command signals.
• the sensor device further comprises a pair of electrodes 351 , 352 adapted to be mounted in conductive contact with the skin of a subject.
• the processor is programmed to identify one or more predefined conditions and apply a voltage between the pair of electrodes in response thereto, such that the flow of current between the pair of electrodes will result in a muscle stimulation signal when the electrodes are in conductive contact with the skin of the user. For example, an alarm signal may be initiated in case the measured blood glucose level is outside a predefined range.
• Fig. 4 shows a skin-mountable device 401 which may represent a drug delivery device as well as a sensor device.
• the device comprises a housing 402 with a base plate portion 403 having a lower mounting surface 405 comprising a pressure-sensitive adhesive which allows the device to be affixed to a skin surface 490 of a subject user.
• the base plate portion is provided with two well-formed recesses in which "gel pads" 410 impregnated with a quantity of conductive electrolytic gel are arranged serving as electrodes.
• Protruding from the mounting surface is arranged a needle-formed device 420 which may represent an infusion needle or a sensor element.
• the mounting surface is provided with an easily removable liner (not shown) overlying the adhesive and the gel pads.
• the needle device is also protected by a cover (not shown) or the device is supplied with the needle device in a retracted position.
• the mounting surface provided with two electrodes 410 and a needle device is shown.
• the specific arrangement, size and configuration of the electrodes as well as the position of the needle device relative thereto is only illustrative and may be adapted in accordance with the actual configuration and intended use of the device.

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• Health & Medical Sciences (AREA)
• Vascular Medicine (AREA)
• Engineering & Computer Science (AREA)
• Anesthesiology (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Hematology (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Diabetes (AREA)
• Dermatology (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)
• Electrotherapy Devices (AREA)

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• 2003
  • 2003-10-06 EP EP03750387A patent/EP1553998A2/de not_active Withdrawn
  • 2003-10-06 AU AU2003269845A patent/AU2003269845A1/en not_active Abandoned
  • 2003-10-06 WO PCT/DK2003/000661 patent/WO2004030727A2/en not_active Application Discontinuation

Non-Patent Citations (1)

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