(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2005/0075670 A1
`Bengtsson
`(43) Pub. Date:
`Apr. 7, 2005
`
`US 2005007567OA1
`
`(54) SIGNAL DEVICE WITH ELECTRO-MUSCLE
`STIMULATION FEATURE
`(76) Inventor: Henrik Bengtsson, Frederiksberg (DK)
`Correspondence Address:
`Reza Green, Esq.
`Novo Nordisk Pharmaceuticals, Inc.
`100 College Road West
`Princeton, NJ 08540 (US)
`(21) Appl. No.:
`10/679,638
`(22) Filed:
`Oct. 6, 2003
`Related U.S. Application Data
`(60) Provisional application No. 60/419,222. Provisional
`application No. 60/428,880, filed on Nov. 25, 2002.
`Foreign Application Priority Data
`
`(30)
`
`Oct. 7, 2002 (DK)................................ PA 2002 O1495
`
`Publication Classification
`
`(51) Int. Cl. ................................................... A61N 1/30
`(52) U.S. Cl. .................................................................. 607/3
`
`(57)
`
`ABSTRACT
`
`The present invention relates to a signal device for conve
`niently providing a user with information, comprising a pair
`of electrodes adapted to be mounted in conductive contact
`with the skin of a Subject, a Voltage Source for providing a
`Voltage between the pair of electrodes, and control means for
`controlling the Voltage applied between the pair of elec
`trodes, the control means being adapted for identifying a
`predefined condition or signal and apply a Voltage between
`the pair of electrodes in response thereto. In an exemplary
`embodiment a drug delivery device is provided further
`comprising a drug reservoir and expelling means for expel
`ling a drug out of the reservoir through associated outlet
`CS.
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`Petitioner - Avation Medical, Inc.
`Ex. 1031, p. 1
`
`

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`Patent Application Publication Apr. 7, 2005 Sheet 1 of 2
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`US 2005/0075670 A1
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`Petitioner - Avation Medical, Inc.
`Ex. 1031, p. 2
`
`

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`Patent Application Publication Apr. 7, 2005 Sheet 2 of 2
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`US 2005/0075670 A1
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`Petitioner - Avation Medical, Inc.
`Ex. 1031, p. 3
`
`

`

`US 2005/0075670 A1
`
`Apr. 7, 2005
`
`SIGNAL DEVICE WITH ELECTRO-MUSCLE
`STIMULATION FEATURE
`
`CROSS REFERENCE TO RELATED
`APPLICATIONS
`0001. This application claims priority under 35 U.S.C.
`119 of Danish application no. PA 2002 01495 filed Oct. 7,
`2002, and U.S. provisional application Nos. 60/419,222 and
`60/428,880 filed on Oct. 17, 2002 and Nov. 25, 2002
`respectively, the contents of both are fully incorporated
`herein by reference.
`0002 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 delivery 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.
`
`BACKGROUND OF THE INVENTION
`0003. In the disclosure of the present invention reference
`is mostly made to the treatment of diabetes by injection of
`insulin, however, this is only a preferred use of the present
`invention.
`0004 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 (insu
`lin resistance) and/or a functional defect in beta cell function
`(non-insulin dependent diabetes mellitus (NIDDM) or type
`2 diabetes).
`0005 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). However, the above-described deterioration is
`reflected in the fact that beta cell stimulators will eventually
`fail to Stimulate the cell, and the patient has to be treated
`with insulin, either as monotherapy, or in combination with
`oral medication in order to improve glucose control.
`0006 Currently, there are two principal modes of daily
`insulin therapy, the first mode including Syringes and insulin
`injection pens. These devices are Simple to use and are
`relatively low in cost, but they require a needle Stick at each
`injection, typically 3-4 times or more per day. The Second
`mode is infusion pump therapy, which entails the purchase
`of a portable but relatively expensive pump, for which
`reason the initial cost of the pump is a barrier to this type of
`therapy. Although more complex than Syringes and pens, 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. Further, in combination with a blood glucose
`Sensor an infusion pump may provide fully automatic closed
`loop control of insulin infusion.
`
`0007 Recently less expensive infusion pumps have been
`proposed 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.
`0008. When using an infusion pump, users desire to hide
`the pump under clothing So as not to seem different from
`normal people, however, this is often inconvenient or
`impractical, especially for diseases Such as diabetes, Since a
`user must have access to the external pump for monitoring
`or administering extra amounts of medication, e.g. bolus
`infusions during the course of the day in relation to the
`intake of meals. If a user has concealed the external pump,
`the user must partially undreSS or carefully maneuver the
`external pump to a location that permits access to the display
`or keypad of the pump.
`0009. In order to provide improved access to an exter
`nally carried infusion pump, U.S. Pat. No. 4,559,037 dis
`closes 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.
`0010 AS appears from the above, 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, pro
`Viding user actuated bolus infusions, or providing feed-back
`controlled closed loop infusion of a desired drug. In addi
`tion, most infusion pumps are provided with control means
`for controlling or checking a number of “internal” condi
`tions 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.
`0011
`For all these types of actions or conditions, it would
`be desirable to communicate information in respect thereof
`to the user. Correspondingly, most infusion pumps (espe
`cially 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. How
`ever, as discussed above, this type of infusion pump is
`preferably worn under the clothing which makes it difficult
`or inconvenient to check any information displayed directly
`by the infusion pump.
`0012. Addressing this problem, different solutions have
`been proposed. 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 indi
`cate a given condition. For example, WO 00/10628 discloses
`
`Petitioner - Avation Medical, Inc.
`Ex. 1031, p. 4
`
`

`

`US 2005/0075670 A1
`
`Apr. 7, 2005
`
`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.
`0013 AS discussed above, when using an infusion pump,
`users often desire to hide the pump So as not to seem
`different from normal people. Indeed, users would also
`prefer not to attract attention during use as would often be
`the case when an audible signal or alarm is Sounded.
`Although it would be possible to set a sound level which is
`primarily to be heard by the user, it cannot be set too low in
`order not to be overheard. However, to assure that a given
`alarm is heard even under relatively noisy conditions, the
`Sound level will in most cases be set So high that it can be
`heard even under Such noisy conditions which again means
`that the Signal or alarm will be considered noisy itself under
`most normal use conditions, e.g. in closed rooms. Indeed, an
`alarm may start out at a low level and escalate until
`acknowledged by the user, however, this would require that
`the user in most Situations would have to manually Stop the
`alarm Signal.
`0014 WO 00/10628 also discloses that a vibratory means
`can be used in an infusion pump to indicate a Signal or alarm.
`When provided, such 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.
`However, 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.
`0.015 Although the above discussion of signal and alarm
`means has been based on drug infusion pumps, these con
`siderations would also be applicable to other types of
`devices Such as a body-mounted glucose Sensor device.
`
`DISCLOSURE OF THE INVENTION
`0016. Having regard to the above-identified problems
`and deficiencies, it is 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. correspond
`ing 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.
`0017 More specifically, 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 con
`ductive 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.
`0018 Electro-muscle stimulation (EMS) 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 muscular
`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.
`0019 However, in contrast to the above known applica
`tions of EMS, 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.
`0020 Thus, in a first aspect the present invention pro
`vides a fluid (e.g. drug) delivery device comprising a res
`ervoir 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 con
`dition 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.
`0021. 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.
`0022. 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 U.S. Pat. Nos. 4,340,048 and
`4.552,561 (based on osmotic pumps), U.S. Pat. No. 5,858,
`001 (based on a piston pump), U.S. Pat. No. 6,280,148
`(based on a membrane pump), U.S. Pat. No. 5,957.895
`(based on a flow restrictor pump (also know as a bleeding
`hole pump)), or U.S. Pat. No. 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.
`0023 The nature of the predefined conditions may be
`chosen in accordance with the circumstances, e.g. in accor
`dance with the actual configuration of the device (e.g. more
`or less complex) and the intended use (e.g. providing more
`or less information). For example, in most applications it
`would be desirable to provide alarm Signals indicative of a
`“primary malfunction 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
`
`Petitioner - Avation Medical, Inc.
`Ex. 1031, p. 5
`
`

`

`US 2005/0075670 A1
`
`Apr. 7, 2005
`
`the reservoir, expelling means or associated outlet means is
`above a preset level indicative of blocking. Correspondingly,
`in most cases it would also be desirable to provide an alarm
`when the amount of drug in the reservoir is below a preset
`level, e.g. close to empty. Depending on the nature of the
`expelling means, 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. For example, in case the expelling means is
`electronically controlled, 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. In case the expelling means is not electronically
`controlled or it is desirable to provide additional detecting
`means, Such independent detecting means may be in the
`form of flow Sensors or pressure Sensors.
`0024.
`Further types of alarms may signal a low power
`Situation or improper operation of the electrodes. For
`example, 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 opera
`tion of the device, e.g. an hourly signal indicating that all
`monitored conditions are OK. To cope with the situation of
`electrode malfunction, 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 pro
`vide the intended Signal.
`0.025
`In an exemplary embodiment the drug delivery
`device is adapted to receive remotely generated commands
`and to control the drug delivery device in accordance
`there with, typically when a user-operated remote control
`device is used to transmit commands to the drug delivery
`device. To indicate that a command has been received, 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. To provide further feedback information to the user,
`it may be indicated that a predefined control action has been
`performed in response to a received command, e.g. a bolus
`infusion.
`0026. The nature of the signals transmitted to the mus
`culature 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.
`0027. For example, in a simple implementation, 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, polar
`ity, frequency, waveform etc. In other words, one type of
`Signal is intended to provide all users with the desired
`information. However, as the actual use conditions for a
`given drug delivery device normally will vary, i.e. the device
`
`may be mounted in different locations just as the users may
`be more or less adipose, it would be desirable if the
`Stimulation characteristics could be adapted to Suit the actual
`conditions, i.e. when placed in a given location on a given
`USC.
`0028 Correspondingly, the drug delivery device may
`advantageously be provided with means allowing the Stimu
`lation 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.
`0029 Further, for each type of stimulation signal (e.g. an
`alarm Signal for occlusion or a signal confirming a received
`command) 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.
`0030 The characteristics of the muscle stimulation sig
`nals should be chosen to provide a significant 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.
`0031. In an exemplary embodiment 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 adhe
`sive) which allows the device to be affixed to the skin of the
`Subject user.
`0032. The electrodes may be of any given type or con
`figuration providing the desired electrical contact under the
`relevant conditions of use. For example, the electrodes may
`be of the type described in U.S. Pat. No. 4,522,211 which
`discloses a Surface member defining a well or chamber 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. In the
`present context 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) overlying the
`adhesive and the gel pads to prevent deterioration and
`leakage of the gel during Storage. The Specific arrangement,
`Size and configuration of the electrodes will depend on the
`actual configuration and intended use of the device.
`0033. In a second aspect the present invention provides a
`Sensor device comprising a Sensor element 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
`
`Petitioner - Avation Medical, Inc.
`Ex. 1031, p. 6
`
`

`

`US 2005/0075670 A1
`
`Apr. 7, 2005
`
`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
`pre-defined 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 Stimu
`lation.
`In an exemplary embodiment the command signals
`0034.
`are in the form of a value indicative of a blood glucose level
`of the Subject. For Such an embodiment 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 element.
`0.035 Turning to the sensor elements per se, relatively
`Small and flexible electrochemical sensors have been devel
`oped for Subcutaneous placement of Sensor electrodes in
`direct contact with patient blood or other extra-cellular fluid
`(see for example U.S. Pat. No. 5,482.473), wherein such
`Sensors can be used to obtain periodic or continuous read
`ings over a period of time. This type of Sensors are described
`in, among others, U.S. Pat. Nos. 5,390,671, 5,391,950,
`5,568,806 and 5,954,643 which hereby are incorporated by
`reference.
`0036). In a further exemplary embodiment of the inven
`tion, a System is provided comprising a Sensor 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 con
`centration 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.
`0037. In a broader aspect, 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.
`0.038. The system may be provided as one or more
`individual units. In an exemplary embodiment a Single,
`Self-contained combined Sensor and prefilled pump is pro
`Vided adapted to be mounted on a skin-Surface of a user. In
`a further exemplary embodiment of the System, an indi
`vidual 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. When the System is
`provided in the form of Separate Sensor and pump assem
`
`blies, it would be possible to offer different types of sensor
`assemblies and different types of pump assemblies.
`0039 Corresponding to a more general aspect of the
`present invention, a general-purpose Signal device is pro
`Vided 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 provid
`ing 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 elec
`trodes, the control means being adapted for identifying a
`predefined condition or signal and apply a Voltage between
`the pair of electrodes in response thereto.
`0040 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.
`When provided with means for receiving externally gener
`ated (cordless) command signals, the signal device may be
`used in combination with devices or Systems which then do
`not have to be skin mounted. For example, Such 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.
`0041. In a different technical field, people with impaired
`hearing 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. Indeed, for any given combina
`tion of the Signal device of the invention and an external
`device, the two devices will have to be adapted to commu
`nicate with each other.
`0042 Corresponding to the drug delivery device in accor
`dance with the first aspect of the invention, 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. Also
`the electrodes may be configured as described above with
`reference to the drug delivery device.
`0043. As used herein, the term “drug” is meant to encom
`pass any drug-containing flowable medicine capable of
`being passed through a delivery means Such as a hollow
`needle in a controlled manner, Such as a liquid, Solution, gel
`or fine Suspension. Representative drugs include pharma
`ceuticals. Such as peptides, proteins, and hormones, biologi
`cally derived or active agents, hormonal and gene based
`agents, nutritional formulas and other Substances in both
`Solid (dispensed) or liquid form. In the description of the
`exemplary embodiments reference will be made to the use of
`insulin. Correspondingly, the term “Subcutaneous' infusion
`is meant to encompass any method of transcutaneous deliv
`ery to a Subject.
`
`Petitioner - Avation Medical, Inc.
`Ex. 1031, p. 7
`
`

`

`US 2005/0075670 A1
`
`Apr. 7, 2005
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`0044) In the following the invention will be further
`described with references to the drawings, wherein
`004.5
`FIG. 1 is a schematic representation of a first
`embodiment of the invention,
`0.046
`FIG. 2 is a schematic representation of a second
`embodiment of the invention,
`0047 FIG. 3 shows a third embodiment,
`0.048
`FIG. 4 shows a fourth embodiment in a side view,
`and
`0049 FIG. 5 shows a view of the mounting surface of the
`fourth embodiment.
`
`DESCRIPTION OF EXEMPLARY
`EMBODIMENTS
`0050 FIGS. 1-5 show schematic representations of
`embodiments of the invention. Correspondingly, the con
`figuration of the different Structures as well as there relative
`dimensions and positions are intended to Serve illustrative
`purposes only.
`0051 More specifically, 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 communica
`tion 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 detect
`ing means for determining the amount of drug actually
`infused. In the shown embodiment 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 Sup
`plied 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. Although the SMPS is shown as a separate
`element, it is preferably provided integrally with a processor
`unit.
`0.052 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. In the shown Schematic
`representation 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 o