WO2007104756A1 - Medical system comprising dual purpose communication means - Google Patents
Medical system comprising dual purpose communication means Download PDFInfo
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- WO2007104756A1 WO2007104756A1 PCT/EP2007/052340 EP2007052340W WO2007104756A1 WO 2007104756 A1 WO2007104756 A1 WO 2007104756A1 EP 2007052340 W EP2007052340 W EP 2007052340W WO 2007104756 A1 WO2007104756 A1 WO 2007104756A1
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- WIPO (PCT)
- Prior art keywords
- unit
- communication
- controller
- transmitter
- medical system
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- 238000004891 communication Methods 0.000 title claims abstract description 113
- 230000006854 communication Effects 0.000 title claims abstract description 113
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- 238000004519 manufacturing process Methods 0.000 abstract description 3
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- NOESYZHRGYRDHS-UHFFFAOYSA-N insulin Chemical compound N1C(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(NC(=O)CN)C(C)CC)CSSCC(C(NC(CO)C(=O)NC(CC(C)C)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CCC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CCC(O)=O)C(=O)NC(CC(N)=O)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CSSCC(NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2C=CC(O)=CC=2)NC(=O)C(CC(C)C)NC(=O)C(C)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2NC=NC=2)NC(=O)C(CO)NC(=O)CNC2=O)C(=O)NCC(=O)NC(CCC(O)=O)C(=O)NC(CCCNC(N)=N)C(=O)NCC(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC(O)=CC=3)C(=O)NC(C(C)O)C(=O)N3C(CCC3)C(=O)NC(CCCCN)C(=O)NC(C)C(O)=O)C(=O)NC(CC(N)=O)C(O)=O)=O)NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)CC=1C=CC=CC=1)C(C)C)CC1=CN=CN1 NOESYZHRGYRDHS-UHFFFAOYSA-N 0.000 description 18
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Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N29/00—Investigating or analysing materials by the use of ultrasonic, sonic or infrasonic waves; Visualisation of the interior of objects by transmitting ultrasonic or sonic waves through the object
- G01N29/22—Details, e.g. general constructional or apparatus details
- G01N29/24—Probes
- G01N29/2481—Wireless probes, e.g. with transponders or radio links
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
- A61B5/0015—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
- A61B5/002—Monitoring the patient using a local or closed circuit, e.g. in a room or building
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/48—Other medical applications
- A61B5/4836—Diagnosis combined with treatment in closed-loop systems or methods
- A61B5/4839—Diagnosis combined with treatment in closed-loop systems or methods combined with drug delivery
-
- 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
- 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
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/37211—Means for communicating with stimulators
- A61N1/37217—Means for communicating with stimulators characterised by the communication link, e.g. acoustic or tactile
-
- H—ELECTRICITY
- H01—ELECTRIC ELEMENTS
- H01Q—ANTENNAS, i.e. RADIO AERIALS
- H01Q1/00—Details of, or arrangements associated with, antennas
- H01Q1/12—Supports; Mounting means
- H01Q1/22—Supports; Mounting means by structural association with other equipment or articles
- H01Q1/2208—Supports; Mounting means by structural association with other equipment or articles associated with components used in interrogation type services, i.e. in systems for information exchange between an interrogator/reader and a tag/transponder, e.g. in Radio Frequency Identification [RFID] systems
-
- H—ELECTRICITY
- H01—ELECTRIC ELEMENTS
- H01Q—ANTENNAS, i.e. RADIO AERIALS
- H01Q1/00—Details of, or arrangements associated with, antennas
- H01Q1/27—Adaptation for use in or on movable bodies
- H01Q1/273—Adaptation for carrying or wearing by persons or animals
-
- H—ELECTRICITY
- H04—ELECTRIC COMMUNICATION TECHNIQUE
- H04B—TRANSMISSION
- H04B5/00—Near-field transmission systems, e.g. inductive or capacitive transmission systems
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
-
- 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
- A61M2205/3569—Range sublocal, e.g. between console and disposable
-
- 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
- A61M2205/3592—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver using telemetric means, e.g. radio or optical transmission
-
- 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
- A61M2205/60—General characteristics of the apparatus with identification means
- A61M2205/6018—General characteristics of the apparatus with identification means providing set-up signals for the apparatus configuration
-
- 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
- A61N1/36007—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of urogenital or gastrointestinal organs, e.g. for incontinence control
Definitions
- the present invention generally relates to electronically controlled medical devices which can be wirelessly controlled and which can be manufactured in a cost effective manner.
- Portable drug delivery devices for delivering a drug to a patient are well known and generally comprise a reservoir adapted to contain a liquid drug, a pump assembly for expelling a drug out of the reservoir and through the skin of the subject via a transcutaneous access device such as a soft cannula or a needle. Such devices are often termed infusion pumps.
- infusion pumps can be divided into two classes.
- the first class comprises durable infusion pumps which are relatively expensive pumps intended for 3-4 years use, for which reason the initial cost for such a pump often is a barrier to this type of therapy.
- the pump offer the advantages of continuous infusion of insulin, precision in dosing and optionally programmable delivery profiles and user actuated bolus infusions in connections with meals.
- Such pumps are normally carried in a belt or pocket close to the body.
- US 6,589,229 discloses a skin-mountable drug infusion device which may have a two-part construction in which more expensive electronic components are housed in a reusable portion and the fluid delivery components are housed in a separable disposable portion (i.e. intended for single use only).
- US patent 6,656,159 discloses a skin-mountable drug infusion device which is fully disposable.
- the traditional durable pump may be worn in a belt at the waist of the user, this allowing the user to operate the pump by directly accessing the user interface on the pump, e.g. in order to change infusion rate or to program a bolus infusion.
- the pump may also be worn hidden under clothing this making operation more difficult.
- the pump and controller may be adapted to communicate with further devices, e.g. US 2005/0171513 discloses a remote controller which may also communicate with external devices such as a glucose monitor, cell phone, PDA or computer using its RF transmitter/receiver, US 2006/0017576 discloses an implantable pump which has two different com- munication means allowing it to communicate with two different external control devices, and US 2006/0020300 discloses an implantable device to which an external antenna can be coupled to increase communication distance before implantation.
- US 2005/0171513 discloses a remote controller which may also communicate with external devices such as a glucose monitor, cell phone, PDA or computer using its RF transmitter/receiver
- US 2006/0017576 discloses an implantable pump which has two different com- munication means allowing it to communicate with two different external control devices
- US 2006/0020300 discloses an implantable device to which an external antenna can be coupled to increase communication distance before implantation.
- US 2004/0098068 discloses a battery-powered micro-stimulator in which a RF transmission coil is also used as a pick-up induction coil for charging of the battery.
- a remote controller For a skin-mountable device, typically comprising an adhesive allowing the device to be attached directly to the skin of the user, a remote controller would appear even more desirable.
- US 6,589,229 and US patent 6,740,059 which are hereby incorporated by reference, disclose semi-disposable and fully disposable infusion devices (which may be termed a local device or unit) which are intended to be operated primarily or entirely by a wireless remote controller (which may be termed a remote device or unit).
- a wireless remote controller which may be termed a remote device or unit
- the delivery device thus does not have to be provided with a user interface such as a display and key- board, the semi-disposable or disposable infusion can be provided more cost-effectively.
- control commands sent from a given remote control unit does only control actuation of the specific delivery device it is intended to control, and not some other delivery device in the proximity of the user.
- the delivery device may be adapted to transmit information back to the remote controller, it is also essential that such information is only received by the corresponding control unit. This issue is applicable to both durable systems and systems comprising disposable units.
- the two devices intended to work together will normally be "paired" by exchange of information between the two devices, this allowing the information sent between the two devices to be specifically coded and thus only accepted by the correspondingly coded device.
- the control- ler may be provided with information as to the type of delivery device in case different types of delivery devices are intended to be used with a given remote controller.
- a remote controller may still be possible to control the delivery device in an undesired way.
- a re- mote controller comes into the hands of a third person, it may be possible for that person to control the delivery device, typically without the knowledge of the user of the delivery device.
- a child may find the remote controller and start to play with it, this resulting in the inadvertently transmission of infusion commands to the delivery device, e.g. the infusion of a bolus of insulin.
- a medical system comprising a first unit and a second unit, the system comprising first means of communication allowing a first group of data types to be transmitted between the first unit and the second unit, the first unit comprising an acoustic transducer having a transducer coil with a plurality of windings, the transducer coil serving as an antenna for wireless signals transmitted between the first and sec- ond units.
- the transducer coil may thus serve as a receiver for wireless signals transmitted from the second to the first unit, and/or as a transmitter for wireless signals transmitted from the first to the second unit. In this way a "parasite" property of the acoustic transducer can be used, i.e.
- the coil as a receiving or transmitting means, thereby replacing a receiving and/or transmitting structure, e.g. a separate receiver or transmitter coil or an antenna, which would otherwise have to be provided, this reducing manufacturing costs.
- the term "first” merely denotes that further means of communication may be provided.
- the term “between” indicates that communication between two units may take place, however, it does not indicate a specific direction.
- the first unit may be a process unit comprising a process unit processor connected to the transducer coil
- the second unit may be a controller unit comprising a first controller unit transmitter adapted to transmit information to the transducer coil, and a controller unit processor connected to the first controller unit transmitter, wherein the first means of communication comprises the transducer coil and the first controller unit transmitter.
- the medical system may further comprise second means of communication allowing a second group of data types to be transmitted between the first unit and the second unit.
- the first means of communication may have a shorter range of communication than the second means of communication under given conditions.
- the second means of communication may be either RF or optical communication. Under the given conditions the first means of com- munication may have a range of communication less than 0.5 meter, and the second means of communication has a range of communication of more than 0.5 meter.
- the first means of communication may use RF communication at a frequency of less than 24 MHz, and the second means of communication may use RF communication at a frequency of more than 24 MHz.
- a medical system in which both the first and second means of communication provides uni-directional communication only between the two units.
- the first unit may be a process unit comprising a process unit receiver, and a process unit processor connected to the process unit receiver and the transducer coil.
- the second unit may be a controller unit comprising a first controller unit transmitter adapted to transmit information to the transducer coil, a second controller unit transmitter adapted to transmit information to the process unit receiver, and a controller unit processor connected to the first and second controller unit transmitters, wherein the first means of communication comprises the transducer coil and the first controller unit transmit- ter, and the second means of communication comprises the process unit receiver and the second controller unit transmitter.
- a medical system in which the first means of communication provides uni-directional communication from the second unit to the first unit, and the second means of communication provides bi-directional communication between the first unit and the second unit.
- the first unit may be a process unit comprising a process unit transmitter, a process unit receiver, and a process unit processor connected to the process unit transmitter, the process unit receiver and the transducer coil.
- the second unit may be a controller unit comprising a first controller unit transmitter adapted to transmit information to the transducer coil, a second controller unit transmitter adapted to transmit information to the process unit receiver, a controller unit receiver adapted for receiving information from the process unit transmitter, and a controller unit processor connected to the first and second controller unit transmitters and the controller unit receiver, wherein the first means of communication comprises the transducer coil and the first controller unit transmitter, and the second means of communication comprises the process unit transmitter, the process unit receiver, the second controller unit transmitter, and the controller unit receiver.
- the first group of data types may comprise a unique ID for the second unit and/or a time stamp.
- the first group of data types may also comprise an activation command, the first unit being adapted to allow one or more types of commands from the second group of data types to be received and executed for a given period of time after an activation command has been received.
- a medical system as described above in which the first unit comprises a reservoir adapted to contain a fluid drug, an expelling assembly adapted for cooperation with the reservoir to expel fluid drug from the reservoir to a subject via an outlet, and processor means for controlling the expelling assembly.
- a medical unit comprising first means of communication allowing a first group of data types to be transmitted between the unit and a further unit, the medical unit comprising an acoustic transducer having a transducer coil with a plurality of windings, the transducer coil serving as a receiver for wireless signals from the further to the first unit.
- the medical unit may be in the form of any of the above-described first and second units, such first and second unit being adapted to communicate with a corresponding second or first unit as described.
- a medical system comprising a first unit and a second unit, the system comprising first means of communication allowing a first group of data types to be transmitted between the first unit and the second unit, and second means of communication allowing a second group of data types to be transmitted between the first unit and the second unit.
- first means of communication allowing a first group of data types to be transmitted between the first unit and the second unit
- second means of communication allowing a second group of data types to be transmitted between the first unit and the second unit.
- At least one means of communication comprises a wireless transmitter and corresponding receiver.
- the first means of communication may be selected from the group comprising RF communication, optical communication, ultrasonic communication, induction and a galvanic contact
- the second means of communication may be selected from the group comprising RF communication, ultrasonic communication, and optical communication.
- the first means of communication may have a shorter range of communication than the second means of communication under given conditions.
- the first means of communication may be NFC (near-field communication) having a range of communication less than 0.5 meter, preferably less than 0.2 meter and most preferably less than 0.1 meter
- the second means of communication has a range of communication of more than 0.5 meter, preferably more than 1 meter and most preferably more than 3 meter.
- the "given conditions" would normally be such conditions that can be found in a normal home or work environment, e.g. as in an office.
- Both the first and second means of communication may be by wireless communication.
- the first means of communication may be RF communication at a frequency of less than 24 MHz
- the second means of communication may be RF communication at a frequency of more than 24 MHz.
- the first group of data types may comprise a unique ID for the second unit, which ID can then only be received by the intended first unit when the two units are in close proximity of each other.
- the second group of data types may comprise a unique ID for the first unit which is then transmitted to the second unit in return for the first ID.
- the first group of data types may comprise an activation (or authorisation) command, the first unit being adapted to allow one or more types of commands from the second group of data types to be received and executed for a given period of time after an activation command has been received.
- an activation (or authorisation) command the first unit being adapted to allow one or more types of commands from the second group of data types to be received and executed for a given period of time after an activation command has been received.
- the re- mote controller would first have to brought close to a given drug delivery device and an activation command transmitted, this action opening a time window of e.g. 5 minutes in which a bolus command will be accepted by the drug delivery device when received using the second means of communication.
- At least one of the means of communication may provide uni-directional communication only between the two units.
- instructions and programs may be transmitted from a remote controller to a drug delivery device, just as e.g. acknowledgement, status and error information may be transmitted from the drug delivery device to the remote controller.
- transmission of pairing information and activation commands may require the first means of communication to be only uni-directionally.
- the medical system may comprise an acoustic transducer (e.g. loudspeaker) having a transducer coil with a plurality of windings, the transducer coil serving as a receiver for wireless signals, e.g. inductive or RF signals.
- a "parasite" property of the acoustic transducer can be used, i.e. using the coil as a receiving means, thereby replacing a receiving structure, e.g. a separate receiver coil or an antenna, which would otherwise have to be provided, this reducing manufacturing costs.
- the first unit may be a process unit adapted to process received data, e.g. a drug delivery device adapted to deliver an amount of drug in accordance with received instructions, or a sensor device adapted to process and/or transmit sensor data from an associated sensor
- the second unit may be a remote controller adapted to e.g. transmit instructions or to receive and store sensor data.
- Each of the units may be of unitary construction or it may be adapted to be used in combination with one or more further units or means.
- a medical system in which a process unit comprises a process unit trans- mitter, a process unit receiver, and a process unit processor connected to the process unit transmitter, the process unit receiver and the transducer coil.
- a controller unit comprises a first controller unit transmitter adapted to transmit information to the transducer coil, a second controller unit transmitter adapted to transmit information to the process unit receiver, a controller unit receiver adapted for receiving information from the process unit transmitter, and a controller unit processor connected to the first and second controller unit transmitters and the controller unit receiver, wherein the first means of communication comprises the transducer coil and the first controller unit transmitter, and the second means of communication comprises the process unit transmitter, the process unit receiver, the second controller unit transmitter, and the controller unit receiver.
- processor covers any combination of electronic circuitry suitable for providing the specified functionality, e.g. processing data and controlling memory as well as all connected input and output devices.
- the processor will typically comprise one or more CPUs or microprocessors which may be supplemented by additional devices for support or control functions.
- a transmitter or a receiver may be fully or partly integrated with the processor, or may be provided by individual units.
- Each of the components making up the processor circuitry may be special purpose or general purpose devices.
- the process unit may comprise a reservoir adapted to contain a fluid drug, an expelling assembly adapted for cooperation with the reservoir to expel fluid drug from the reservoir to a subject via an outlet, and processor means for controlling the expelling assembly.
- the reservoir may be any suitable structure adapted to hold an amount of a fluid drug, e.g. a hard reservoir, a flexible reservoir, a distensible or elastic reservoir.
- the reservoir may e.g. be pre- filled, user-fillable or in the form of a replaceable cartridge which again may be prefilled or fillable.
- the expelling assembly may be of any desired type, e.g. a membrane pump, a pis- ton-cylinder pump or a roller-tube pump.
- the processor means is adapted to receive flow instructions from a control unit, the control unit comprising a user interface allowing a user to enter flow instruction for subsequent transmission to the process unit, e.g. programming a basal infusion rate profile or a bolus.
- the process unit may be adapted to be im- planted or the outlet may comprise or be adapted to connect to a transcutaneous access device, thereby allowing a fluid drug to be expelled out of the reservoir and through the skin of the subject via the transcutaneous access device.
- the first group of data types may comprise at least one type of command controlling the delivery of an amount of fluid drug to the subject.
- a user desires to program a bolus infusion of a drug such as insulin
- a drug such as insulin
- such an instruction can only be transmitted to the process unit when the remote controller is moved into the vicinity thereof, this preventing to a high degree that other people will be able to pick up a given remote controller and inadvertently transmit a bolus or other infusion command to a drug delivery device controlled by that remote controller.
- the first unit may comprise a processor adapted to transmit and/or process data acquired via a sensor device, and may include a transcutaneous sensor device adapted for cooperation with the processor.
- the medical system of the invention may further comprise a transcutaneous device unit comprising a transcutaneous device, e.g. access device or sensor device, a mounting surface adapted for application to the skin of a subject, e.g. an adhesive surface, wherein the transcutaneous device unit and the first unit are adapted to be secured to each other to form a combined device.
- a transcutaneous device unit comprising a transcutaneous device, e.g. access device or sensor device, a mounting surface adapted for application to the skin of a subject, e.g. an adhesive surface, wherein the transcutaneous device unit and the first unit are adapted to be secured to each other to form a combined device.
- a medical unit comprising first means of communication allowing a first group of data types to be transmitted between the unit and a further unit, and second means of communication allowing a second group of data types to be transmitted between the unit and the further unit.
- the medical unit may be in the form of any of the above-described first and second units, such first and second unit being adapted to communicate with a corresponding second or first unit as described.
- the invention further provides a method of operating a medical system comprising first and second units, the method comprising the steps of (i) providing a first unit and a second unit, the first unit comprising an acoustic transducer having a transducer coil with a plurality of windings, (ii) wirelessly transmitting data between the first and second unit using the coil as an antenna, and (iii) generating an audible signal using the acoustic transducer.
- the method may incorporate steps corresponding to the above-described device features.
- drug is meant to encompass any drug-containing flowable medicine capable of being passed through a delivery means such as a cannula or hollow needle in a controlled manner, such as a liquid, solution, gel or fine suspension.
- Representative drugs include pharmaceuticals such as peptides, proteins, and hormones, biologically de- rived or active agents, hormonal and gene based agents, nutritional formulas and other substances in both solid (dispensed) or liquid form.
- a delivery means such as a cannula or hollow needle in a controlled manner, such as a liquid, solution, gel or fine suspension.
- Representative drugs include pharmaceuticals such as peptides, proteins, and hormones, biologically de- rived 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.
- figs. 1-3 shows in perspective views sequences of use for a first embodiment of a drug delivery device
- fig. 4 shows a perspective view of the interior of the reservoir unit of fig. 1
- fig. 5 shows a schematic representation of a process unit and a control unit
- fig. 6 shows a further schematic representation of a local unit and a remote unit
- IfK-IC show in schematic form a circuitry divided in three images (to be read in directions from A to C)
- figs. 8A-8K (numeral 8(I) not used) show steps of a pairing procedure between two medical units
- figs. 9A-9D show steps of transmitting a command between two medical units.
- the patch unit 2 comprises a transcutaneous device in the form of a hollow infusion device, e.g. a needle or soft cannula, however, the needle or cannula may be replaced with any desirable transcutaneous device suitable for delivery of a fluid drug or for sensing a body parameter.
- a transcutaneous device in the form of a hollow infusion device, e.g. a needle or soft cannula, however, the needle or cannula may be replaced with any desirable transcutaneous device suitable for delivery of a fluid drug or for sensing a body parameter.
- fig. 1 shows a perspective view of medical device in the form of a modular skin-mountable drug delivery device 1 comprising a patch unit 2 and a pump unit 5 (as the pump unit comprises a reservoir it may also be termed a reservoir unit).
- a pump unit comprises a reservoir it may also be termed a reservoir unit.
- each of the units are preferably enclosed in its own sealed package (not shown).
- the embodiment shown in fig. 1 comprises a patch unit provided with an insertable transcutaneous device, e.g. needle, cannula or sensor.
- an insertable transcutaneous device e.g. needle, cannula or sensor.
- the patch unit comprises a flexible patch portion 10 with a lower adhesive mounting surface 12 adapted for application to the skin of a user, and a housing portion 20 in which a transcutaneous device (not shown) is arranged.
- the transcutaneous device comprises a pointed distal end adapted to penetrate the skin of a user, and is adapted to be arranged in fluid com- munication with the pump unit.
- the pointed end of the transcutaneous device is moveable between an initial position in which the pointed end is retracted relative to the mounting surface, and an extended position in which the pointed end projects relative to the mounting surface.
- the transcutaneous device may also be moveable between the extended position in which the distal end projects relative to the mounting surface, and a retracted position in which the distal end is retracted relative to the mounting surface.
- the patch unit further comprises user-gripable actuation means in the form of a first strip- member 21 for moving the transcutaneous device between the initial and the second position when the actuation means is actuated, and a user-gripable second strip-member 22 for removing the patch from the skin surface.
- the second strip may also me used to move the dis- tal end of the transcutaneous device between the extended and the retracted position.
- the housing further comprises user-actuatable male coupling means 31 in the form of a pair of resiliency arranged hook members adapted to cooperate with corresponding female coupling means 51 on the pump unit, this allowing the pump unit to be releasable secured to the patch unit in the situation of use.
- a flexible ridge formed support member 13 extends from the housing and is attached to the upper surface 1 1 of the patch. The adhesive surface is supplied to the user with a peelable protective sheet.
- the pump unit 5 comprises a pre-filled reservoir containing a liquid drug formulation (e.g. insulin) and an expelling assembly for expelling the drug from the reservoir through the needle in a situation of use.
- the reservoir unit has a generally flat lower surface adapted to be mounted onto the upper surface of the patch portion, and comprises a protruding portion 50 adapted to be received in a corresponding cavity of the housing portion 20 as well as female coupling means 51 adapted to engage the corresponding hook members 31 on the needle unit.
- the protruding portion provides the interface between the two units and comprises a pump outlet and contact means (not shown) allowing the pump to detect that it has been assembled with the patch.
- the user In a situation of use the user assembles the two units which are then mounted on a skin surface where after the transcutaneous device is inserted and the pump is ready to operate. Operation may start automatically as the transcutaneous device is inserted, or the pump may be started via the remote unit, see below. Before the pump unit is mounted to the patch unit, the user will normally have paired the pump unit with the remote unit, see below. In an alternative situation of use the user may first mount the patch unit to a skin surface and insert the transcutaneous device, after which the pump unit is mounted to the patch unit.
- the pump unit may be removed from the patch unit before or after the patch unit is removed from the skin. Thereafter the pump unit can be used again with fresh patch units until it has been emptied or the patch has to be changed again.
- Fig. 4 shows the pump unit with an upper portion of the housing removed.
- the pump unit comprises a reservoir 760 and an expelling assembly comprising a pump assembly 300 as well as processor means 580 and a coil actuator 581 for control and actuation thereof.
- the pump assembly comprises an outlet 322 for connection to a transcutaneous access device and an opening 323 allowing a fluid connector arranged in the pump assembly to be actuated and thereby connect the pump assembly with the reservoir.
- the reservoir 560 is in the form of prefilled, flexible and collapsible pouch comprising a needle-penetratable septum adapted to be arranged in fluid communication with the pump assembly.
- the lower portion of the housing comprises a transparent area (not seen) allowing a user to inspect a portion of the reservoir.
- the shown pump assembly is a mechanically actuated membrane pump, however, the reservoir and expelling means may be of any suitable configuration.
- the processor means comprises a PCB or flex-print to which are connected a microprocessor 583 for controlling, among other, the pump actuation, contacts (i.e. sensors) 588, 589 cooperating with corresponding contact actuators on the patch unit or the remote unit (see below), signal generating means 585 for generating an audible and/or tactile signal, a display (if provided), a memory, a transmitter and a receiver.
- An energy source 586 provides energy.
- the contacts may be protected by membranes which may be formed by flexible portions of the housing.
- the local unit may also be provided as a unitary unit.
- the present disclosure is broadly applicable to any form of system comprising a pump unit in combination with a controller unit or other external unit, e.g. a PC or PDA.
- the present disclosure may be used with programmable ambulatory insulin infusion pumps of the sort currently commercially available from a number of manufacturers, including without limitation and by way of example, Medtronic MiniMed under the trademark PARADIGM, lnsulet Corporation under the trademark OmniPod, Smiths Medical under the trademark Deltec COZMO, and others, these pumps either being provided with a remote control or being adaptable to be used with one.
- FIG. 5 shows a schematic representation of a process unit 200 (here corresponding to the pump unit 5 of fig. 1 ) and a controller unit 100 (here in the form of a wireless "remote controller” or “external communication device” for the pump unit). It is considered that the general design of such units is well known to the skilled person, however, for a more detailed description of the circuitry necessary to provide the desired functionality of the present invention reference is made to incorporated US 2003/0065308.
- fig. 5 depicts a simplified block diagram of various functional components or modules (i.e. single components or groups of components) included in the pump unit 200 and remote controller 100.
- the remote controller unit includes a housing 101 , a remote processor 1 10 including a CPU, memory elements for storing control programs and operation data and a clock, an LCD display 120 for providing operation for information to the user, a keypad 130 for taking input from the user, an audio alarm 140 for providing information to the user, a vibrator 150 for providing information to the user, a main battery 160 for supplying power to the controller, a backup battery 161 to provide memory maintenance for the controller, a remote radio frequency (RF) telemetry transmitter 170 for sending signals to the pump unit, a remote radio frequency (RF) telemetry receiver 180 for receiving signals from the pump unit, and a second transmitter 190.
- RF radio frequency
- the controller further comprises a port 185, e.g. an infrared (IR) or RF input/output system, or a USB port for communicating with a further device, e.g. a blood glucose meter (BGM), a continuous blood glucose meter (CGM), a PC or a PDA.
- a port 185 e.g. an infrared (IR) or RF input/output system, or a USB port for communicating with a further device, e.g. a blood glucose meter (BGM), a continuous blood glucose meter (CGM), a PC or a PDA.
- a port 185 e.g. an infrared (IR) or RF input/output system
- a USB port for communicating with a further device, e.g. a blood glucose meter (BGM), a continuous blood glucose meter (CGM), a PC or a PDA.
- BGM blood glucose meter
- CGM continuous blood glucose meter
- PC
- the pump unit 200 includes a housing 201 , local processor elec- tronics 210 including a CPU and memory elements for storing control programs and operation data, battery 260 for providing power to the system, a process unit RF telemetry transmitter 270 for sending communication signals to the remote unit, a process unit radio frequency (RF) telemetry receiver 280 for receiving signals from the remote unit, a second process unit receiver 240 (which may be in the form of a coil of an acoustic transducer used in an audio alarm for providing feedback to the user), a reservoir 230 for storing a drug, and a pump assembly 220 for expelling drug from the reservoir through a transcutaneous device to the body of a patient.
- local processor elec- tronics 210 including a CPU and memory elements for storing control programs and operation data
- battery 260 for providing power to the system
- a process unit RF telemetry transmitter 270 for sending communication signals to the remote unit
- RF radio frequency
- second process unit receiver 240 which may
- the pump unit may also comprise an LCD display for providing information to the user, a keypad for taking input from the user, and a vibrator or other tactile actuator for providing information to the user.
- RF transmission may be in accordance with a standard protocol such as Bluetooth ®.
- Fig. 6 shows a schematic representation of a medical system 400 comprising a process unit
- the system comprises first means of communication allowing a first group of data types to be transmitted between the first unit and the second unit, and second means of communication allowing a second group of data types to be transmitted between the first unit and the second unit.
- the first means of communication is by NFC (Near-Field Communication) having a transmitter coil 41 1 and a receiver coil 421. Transmission may be by induction using a 125 kHz signal providing a range of approximately 10 cm. The receiver coil may form part of a conventional loudspeaker (see below).
- the second means of communication is bi- directional using 2.4 GHz RF communication using a pair of antennas 412, 422, this providing a range of communication of several meters.
- a pairing signal is sent by NFC.
- the signal comprises a pairing start code, a remote ID and a sequential pump number.
- an acknowledgement signal is sent using RF transmission, the acknowledgement comprising the remote ID and the sequential pump number. In this way the two units can only transmit and receive signals intended for the paired pump respectively controller unit.
- the remote unit is paired with the next pump unit using the next sequential number, only signals to or from the new pump is transmitted respectively received.
- Fig. 7 shows in schematic form circuitry adapted to receive signals generated by induction in a coil (e.g. a loudspeaker coil), the signals being transformed from analog to digital represen- tation which can then be processed by a processor in the pump unit. More specifically, an example of a receiver stage optimized for ASIC-implementation is shown. Amplification and double rectifying of the input signal, from the receiver coil, is performed by the differential stage circuit centred around M3 & M5 seen in the middle. The digitalized signal is noise reduced by the Schmidt-trigger circuit seen on the right of the output voltage signal placed over the capacitance, Cl
- a pump unit comprising an insulin formulation is stored in a refrigerator (fig. 8A).
- a new pump unit is taken out from the refrigerator (fig. 8B)
- unpacking the pump starts it's electrical life.
- the expiration date printed on the pump unit is checked by the user (fig. 8C).
- a patch unit is mounted on a suitable skin portion of the user. The user then grabs the patch unit and inserts the pump unit by pressing it into the patch unit (fig. 8D).
- the pump unit is ready for pairing which is indicated by a beep signal (fig. 8E). Activating the pairing mode allows pairing of the remote (fig. 8F).
- bolus type and amount is set by the user (fig. 9A)
- the user accept the bolus.
- the display indicates by "safe transmit" that the desired bolus command can only be transmitted using NFC, i.e. by bringing the remote controller into close proximity of the pump unit (fig. 9B).
- the user swipes the pump with the re- mote controller to authenticate the bolus command. Transmission may take place either automatically or this may happen either automatically or by pressing a key.
- the pump beeps to acknowledge reception of the bolus command (fig. 9C) and transmits an acknowledgement to the remote commander using RF communication, the remote controller showing a checkmark in the display to indicate that the bolus command has been correctly received by the pump unit (fig. 9D).
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Abstract
Description
Claims
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CN2007800090788A CN101401314B (en) | 2006-03-13 | 2007-03-13 | Medical system comprising dual purpose communication means |
US12/282,579 US20090062778A1 (en) | 2006-03-13 | 2007-03-13 | Medical System Comprising Dual-Purpose Communication Means |
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Also Published As
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US20090062778A1 (en) | 2009-03-05 |
EP1997234A1 (en) | 2008-12-03 |
CN101401314A (en) | 2009-04-01 |
JP2009529930A (en) | 2009-08-27 |
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