(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`
`(19) World Intellectual Property Organization
`International Bureau
`
`(43) International Publication Date
`5 February 2009 (05.02.2009)
`
`PCT
`
`(10) International Publication Number
`WO 2009/016635 A2
`
`(51) International Patent Classification:
`A61M 5/142 (2006 01)
`A61M 5/172 (2006 01)
`
`(21) International Application Number:
`PCT/IL2008/001056
`
`(22) International Filing Date:
`
`3 1 July 2008 (3 1 07 2008)
`
`(25) Filing Language:
`
`(26) Publication Language:
`
`English
`
`English
`
`(30) Priority Data:
`60/963,045
`60/999,654
`
`1 August 2007 (01 08 2007)
`19 October 2007 (19 10 2007)
`
`US
`US
`
`except US):
`(for all designated States
`(71) Applicant
`MEDINGO LTD.
`[IL/IL], Yoqneam Industrial Park,
`Building 7, P O Box 261, 20692 Yoqneam Ilht (IL)
`
`(81) Designated States (unless otherwise indicated for every
`kind of national protection available): AE, AG, AL, AM,
`AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, CA,
`CH, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE,
`EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID,
`IL, IN, IS, JP, KE, KG, KM, KN, KP, KR, KZ, LA, LC, LK,
`LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN, MW,
`MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PG, PH, PL, PT,
`RO, RS, RU, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TJ,
`TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM,
`ZW
`
`(84) Designated States (unless otherwise indicated for every
`kind of regional protection available): ARIPO (BW, GH,
`GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM,
`ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM),
`European (AT,BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI,
`FR, GB, GR, HR, HU, IE, IS, IT, LT,LU, LV,MC, MT, NL,
`NO, PL, PT, RO, SE, SI, SK, TR), OAPI (BF, BJ, CF, CG,
`CI, CM, GA, GN, GQ, GW, ML, MR, NE, SN, TD, TG)
`
`Published:
`(72) Inventor; and
`(for US only): YODFAT, Ofer — without international search report and to be republished
`(75) Inventor/Applicant
`upon receipt of that report
`[IL/IL], 72 Galil St , 71908 Maccabim Reut (IL)
`
`(54) Title: DETACHABLE PORTABLE INFUSION DEVICE
`
`FIG. 6a
`(57) Abstract: A portable therapeutic apparatus and a method for controlling the apparatus are provided In one aspect the appa
`ratus and the method can be implemented using a patch unit (100, 200) removably attachable to a cradle unit (20), said cradle unit
`removably attachable to the body of the patient, a position detector (1000) compp sing a patch portion (900) and a cradle portion
`(800), said patch portion coupled to the patch unit, said cradle portion coupled to the cradle unit, a processor adapted for receiving a
`position indication signal from the at least one position detector, said position indication signal corresponding to a physical proxim
`ity of the patch portion to the cradle portion, and, wherein the portable therapeutic apparatus is adapted for at least one therapeutic
`function selected from the group consisting of delivering a therapeutic fluid into the body of the patient and sensing a bodily analyte
`
`Page 1 of 66
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`DETACHABLE PORTABLE INFUSION DEVICE
`
`FIELD OF THE INVENTION
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`[0001] A system, device and a method for sustained medical infusion of fluids are described.
`
`Some embodiments relate generally to a miniature portable infusion device that can be attached
`
`to and detached from a patient's body and that is configured to accurately dispense fluids. Some
`
`embodiments relate to a skin securable infusion device that can be periodically disconnected
`
`from and reconnected to the body of the patient. Some embodiments relate to a skin securable
`
`infusion device that can be disconnected from and reconnected to the body and to a method for
`
`detecting whether the infusion device is disconnected or reconnected to the body and for
`
`controlling the device's operation accordingly.
`
`BACKGROUND OF THE INVENTION
`
`[0002] Medical treatment of several illnesses requires continuous drug infusion into various
`
`body compartments, such as subcutaneous and intra-venous injections. Diabetes mellitus patients,
`
`for example, require administration of varying amounts of insulin throughout the day to control
`
`their blood glucose levels. In recent years, ambulatory portable insulin infusion pumps have
`
`emerged as a superior alternative to multiple daily syringe injections of insulin. These pumps,
`
`which deliver insulin at a continuous basal rate as well as in bolus volumes, were developed to
`
`liberate patients from repeated self-administered injections, and allow them to maintain a near-
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`normal daily routine. Both basal and bolus volumes must be delivered in precise doses,
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`according to individual prescription, since an overdose or under-dose of insulin could be fatal.
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`[0003] A first generation of portable infusion pumps refers to "pager-like" devices with a
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`reservoir contained within the device's housing. In the first generation devices, a long tube
`
`delivers insulin from the pump, which is attached to a belt on the patient, to a remote insertion
`
`site. Such devices are disclosed, for example, in U.S. Patents Nos. 3,771,694, 4,657,486 and
`
`4,498,843. These devices represent a significant improvement over multiple daily injections, but
`
`nevertheless, they all suffer from several major drawbacks, among which are the large size and
`
`weight of the device, long tubing and lack of discreetness.
`
`[0004] To avoid consequences associated with employing a long delivery tube, a new concept
`
`was proposed, which was implemented in second generation pumps. The second generation
`
`pumps concept relates to a remote controlled skin adherable device with a housing having a
`
`bottom surface adapted for contact with the patient's skin, a reservoir disposed within the
`
`housing, and an injection needle adapted for communication with the reservoir. This paradigm
`
`was described, for example, in U.S. Patents Nos. 5,957,895, 6,589,229, 6,740,059, 6,723,072 and
`
`6,485,461. The second generation devices also have several limitations: they are bulky, the
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`remote control unit should always be at hand, and they are expensive because the entire device
`
`should be discarded every 2-3 days.
`
`[0005] Third generation skin adherable devices were devised to avoid the cost issues of the
`
`second generation devices and to extend patient customization. An example of such a device was
`
`described in the co-owned, co-pending U.S. Patent Application Serial No. 11/397,1 15 and
`
`International Application No. PCT/IL06/001276, the disclosures of which are incorporate herein
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`by reference in their entireties. The third generation devices contain a remote control unit and a
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`skin adherable patch unit (also referred to as a "dispensing patch unit") that includes two parts:
`
`(1) a reusable part containing driving and pumping mechanisms, electronics and other relatively
`
`expensive components, and (2) a disposable part containing a reservoir and, in some
`
`embodiments, batteries. A tube can also be provided which delivers the fluid from the reservoir
`
`to an outlet port that contains a connecting lumen.
`
`[0006] This concept can provide a cost-effective skin adherable infusion device and allow
`
`diverse usage of the device, such as using it with various reservoir sizes, various needle and
`
`cannula types, etc.
`
`[0007] In the co-pending, co-owned U.S. Patent Application No. 12/004,837, and International
`
`Patent Application No. PCT/IL07001578, both filed December 20, 2007, and both claiming
`
`priority to U.S. Provisional Patent Application No. 60/876,679, filed December 22, 2006, the
`
`disclosures of which are incorporated herein by reference in their entireties, a fourth generation
`
`patch unit that can be disconnected from and reconnected to a skin adherable cradle unit was
`
`disclosed. In the fourth generation the patch unit, after reservoir filling, is mounted on the body
`
`by the following steps:
`
`[0008]
`
`1) Cradle unit is adhered to the skin;
`
`[0009]
`
`2) Cannula is inserted through a cradle unit passageway (also referred to as a
`
`"well") into the subcutaneous tissue. The cannula, including a rubber septum, can be connected
`
`to the cradle unit's "well";
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`[0010]
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`3) The patch unit is connected to the cradle unit. The connecting lumen pierces a
`
`rubber septum allowing fluid communication between the reservoir, cannula and the body.
`
`[0011] In the co-pending, co-owned U.S. Patent Application No. 11/706,606, the disclosure of
`
`which is incorporated herein by reference in its entirety, a device containing a dispensing patch
`
`unit (called also " insulin dispensing patch") and an analyte sensing means (i.e., continuous
`
`glucose monitor) was disclosed. This dual function device is configured to have similar
`
`configuration to the one outlined above and can also be disconnected from and reconnected to a
`
`cradle unit upon patient discretion.
`
`[0012] In some conventional systems, although basal delivery should be continuously
`
`administered, it is often interrupted due to periodic pump disconnection. In some situations,
`
`pump disconnection is mandatory, for example during sauna and hot bath because insulin cannot
`
`tolerate high temperatures. However, there are occasions in which a short time disconnection can
`
`substantially improve daily activity and patient satisfaction. If the operation of the patch unit's
`
`driving mechanism is not suspended prior to disconnection (for example, the user forgets to do
`
`so, the disconnection is unintentional, etc.), the patch unit will continue to dispense insulin even
`
`though it is not connected to the cradle unit, thus wasting precious insulin and battery power.
`
`Moreover, the patient's ability to control the precise amount of delivered insulin will be
`
`diminished.
`
`SUMMARY OF THE INVENTION
`
`[0013] An apparatus and a method for delivering a therapeutic fluid into a body of a patient are
`
`provided. In one aspect the device and the method can be implemented using a patch unit
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`removably attachable to a cradle unit, said cradle unit removably attachable to the body of the
`
`patient; a position detector comprising a patch portion and a cradle portion, said patch portion
`
`coupled to the patch unit, said cradle portion coupled to the cradle unit; a processor adapted for
`
`receiving a position indication signal from the at least one position detector, said position
`
`indication signal corresponding to a physical proximity of the patch portion to the cradle portion;
`
`the processor is further adapted for receiving at least one command from the patient; and,
`
`wherein the portable therapeutic device is adapted for at least one therapeutic function selected
`
`from the group consisting of delivering a therapeutic fluid into the body of the patient and
`
`sensing a bodily analyte.
`
`[0014] For example, the patch unit can comprise a reusable part and a disposable part; the
`
`disposable part can comprises a reservoir for storing the therapeutic fluid, and, the reusable part
`
`can comprise a metering portion for delivering the therapeutic fluid from said reservoir into the
`
`body of the patient. The patch unit can be configured to be remotely controlled. In some
`
`implementations, the therapeutic fluid can be insulin.
`
`[0015] The processor can be adapted to control an operation of the patch unit based on the
`
`connection status signal received from the position detector. The processor can further be
`
`adapted to control the delivery of the therapeutic fluid into the patient based on the connection
`
`status signal. The processor can also be adapted to record commands received from the patient in
`
`a memory component. The processor is further adapted to deactivate at least one component of
`
`the apparatus based on the connection status signal received from the position detector. The
`
`processor can also be configured to initiate a notification to the patient, said notification
`
`corresponding to the connection status signal.
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`[0016] In some implementations, the cradle unit can have a cradle base configured as a flat sheet
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`with an adhesive layer facing a skin of the patient and having anchoring means for connection
`
`and disconnection of said patch unit; and, a well configured to protrude upwardly from said
`
`cradle base to allow alignment and appropriate connection of said patch unit. For example, the
`
`well can be adapted for insertion of a cannula into the body of the patient.
`
`[0017] In some implementations, the patch unit can be configured to use peristaltic pump to
`
`deliver the therapeutic fluid into the body of the patient. It can also be configured to use a piston
`
`to deliver the therapeutic fluid to the body of the patient.
`
`[0018] In some implementations the position detector can comprise an optical sensor having a
`
`light source component and a light detector component. The position detector can also comprise
`
`an electro-magnetic detector and/or a magnetic proximity detector.
`
`[0019] In another aspect, a method for activating a device for delivering a therapeutic fluid into a
`
`body can also be provided. For example, the method can comprise attaching a patch unit to a
`
`cradle unit; attaching the cradle unit to the body; generating an activation request for at least one
`
`component of at least one of the patch unit and the cradle unit based on a connection status signal
`
`generated by a position detector, said position detector comprising a patch portion and a cradle
`
`portion, the patch portion coupled to the patch unit, the cradle portion coupled to the cradle unit,
`
`said connection status signal corresponding to a physical proximity of the patch portion to the
`
`cradle portion.
`
`[0020] A device is disclosed that can deliver therapeutic fluid into the body and/or monitor
`
`analyte concentration levels. For example, the device can include the following units:
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`o A patch unit, which can be remotely controlled or manually controlled by
`
`operating buttons. In some embodiments, the patch unit can include two
`
`parts: reusable and disposable. The disposable part can be configured to
`
`include a reservoir and an outlet port with a connecting lumen. The
`
`reusable part can be configured to include electronics and at least a portion
`
`of a dispensing mechanism.
`
`o A cradle unit, which can be adherable to the patient's skin, e.g., by an
`
`adhesive.
`
`[0021] After attaching the cradle unit to the skin, a cannula can be inserted into the subcutaneous
`
`compartment of the patient's body through a dedicated passageway ("well") provided in the
`
`cradle unit. During patch-cradle connection, the connecting lumen pierces a self-sealable rubber
`
`septum that seals the "well". Thus, fluid communication is established between the patch unit
`
`and the cannula. The patch unit can be connected to and disconnected from the cradle unit upon
`
`patient's discretion.
`
`[0022] According to some embodiments, the device can be configured to include a position
`
`detector configured to detect whether the patch unit is connected to or disconnected from the
`
`cradle unit. The position detector, according to some embodiments, includes two parts, one of
`
`them being located on the patch unit ("patch portion") and the other on the cradle unit ("cradle
`
`portion"). A central processing unit ("CPU")/processor can be provided, which receives the
`
`position detector's output (connected/disconnected) and controls the patch unit's operation and
`
`fluid delivery, accordingly. For example, when the patch is disconnected, fluid delivery can be
`
`terminated and after reconnection, it can be resumed.
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`[0023] In some embodiments, the position detector's operation can be based on optical-type
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`detectors or other means. For example, a light emitting diode ("LED") and a light detector can be
`
`adjacently located on the patch unit and the cradle unit can be provided with a reflective surface.
`
`Upon disconnection or reconnection, the CPU receives no/yes light inputs from the position
`
`detector and accordingly assigns the patch unit a "disconnected" or "connected" position status.
`
`[0024] In some embodiments, the position detector is configured to operate as an electronic
`
`switch. For example, two conductive surfaces (in some embodiments, the surfaces can be
`
`fabricated from gold, nickel, or any other suitable material) can be attached to the lower surface
`
`of the patch unit's housing, and a third conductive surface can be attached to the cradle unit. The
`
`CPU is configured to assign the patch a certain position status according to whether the patch-
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`cradle conductive surfaces are connected or disconnected ("ON-OFF" state).
`
`[0025] Some embodiments include a device that includes a dispensing and/or sensing patch unit
`
`that can be disconnected from and reconnected to a skin adherable cradle unit, and that further
`
`includes a position detector, while the operation of the device can be controlled according to
`
`position detection.
`
`[0026] Some embodiments include a device that can includes a miniature patch unit that can be
`
`configured to continuously dispense insulin and/or monitor glucose levels, and that further
`
`incorporates a position detector, and whose operation can be controlled according to position
`
`detection.
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`[0027] Some embodiments include a patch unit that can be disconnected from and reconnected
`
`to a cradle unit and enables users to safely disconnect the patch unit for a certain period of time.
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`[0028] Some embodiments include a device that includes a patch unit that can be remotely
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`controlled and can be disconnected from and reconnected to a skin adherable cradle unit and that
`
`includes a position detector, and whose operation can be controlled according to position
`
`detection.
`
`[0029] Some embodiments include a device that includes a patch unit having two parts, e.g., a
`
`reusable part and a disposable part, and that can be disconnected from and reconnected to a skin
`
`adherable cradle unit, and that further includes a position detector, and whose operation can be
`
`controlled according to position detection.
`
`[0030] Some embodiments include a device which is miniature, discreet, economical for the
`
`users and highly cost effective for the payer, and that incorporates a position detector, and whose
`
`operation can be controlled according to position detection.
`
`[0031] Some embodiments include a patch unit that continuously monitors body glucose (e.g.,
`
`blood, ISF) levels and can concomitantly deliver insulin into the body, and that incoiporates a
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`position detector, and whose operation can be controlled according to position detection.
`
`[0032] Some embodiments include a semi closed-loop system that monitors glucose levels and
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`dispenses insulin according to sensed glucose levels, and incorporates a position detector and
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`operation of the device can be controlled according to position detection.
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`[0033] Some embodiments describe a device that includes a dispensing and/or sensing patch unit
`
`(hereinafter, referred to generally as a "patch" or a "patch unit") that can be disconnected from
`
`and reconnected to a skin adherable cradle unit, and that includes a detector device that is
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`configured to detect whether the patch is connected or disconnected (hereinafter, referred to as
`
`"position detector"). It is also desirable to provide a method for controlling patch operation
`
`according to a position of the patch that has been detected by the position detector.
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`[0034] It is desirable to provide a device that includes a miniature patch that can continuously
`
`dispense insulin and/or monitor glucose levels and incorporates a position detector and its
`
`operation is controlled according to position detection.
`
`[0035] It is also desirable to provide a dispensing patch that can be disconnected from and
`
`reconnected to a cradle unit and that enables users to safely disconnect the patch unit for a period
`
`of time.
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`[0036] It is desirable to provide a device that contains a patch unit that can be remotely
`
`controlled and can be disconnected from and reconnected to a skin adherable cradle unit and that
`
`further includes a position detector, whose operation can be controlled according to position
`
`detection.
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`[0037] It is desirable to provide a device that contains a patch unit, which includes two parts, e.g.,
`
`a reusable part and a disposable part, and which can be disconnected from and reconnected to a
`
`skin adherable cradle unit, and incorporates a position detector, whose operation can be
`
`controlled according to position detection.
`
`[0038] It is desirable to provide a device that is miniature, discreet, economical for the users, and
`
`cost effective for the payer and that incorporates a position detector, whose operation can be
`
`controlled according to position detection.
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`[0039] It is desirable to provide a device that can continuously monitor body glucose (e.g. blood
`
`glucose, ISF glucose) levels and concomitantly deliver insulin into the body, and that
`
`incorporates a position detector, while the operation of the device can be controlled according to
`
`position detection.
`
`[0040] It is desirable to provide a device that constitutes a semi closed-loop system that monitors
`
`glucose levels and dispenses insulin according to sensed glucose levels, and that incorporates a
`
`position detector, while the operation of the device can be controlled according to position
`
`detection.
`
`[0041] The foregoing and other features, aspects, and advantages of the present invention will be
`
`more apparent from the following detailed description, which illustrates exemplary embodiments
`
`of the present invention.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
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`[0042] FIGS la-b illustrate an exemplary device having a patch unit and a remote control unit.
`
`[0043] FIGS. 2a-b illustrate an exemplary device having a patch unit provided with operating
`
`buttons and a display.
`
`[0044] FIGS. 3a-c illustrate an exemplary cradle unit having a cradle base and a well.
`
`[0045] FIGS. 4a-d illustrate an exemplary connection of a patch unit to a skin adherable cradle
`
`unit.
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`[0046] FIGS. 5a-d illustrate exemplary patch units that can be configured to be connected to a
`
`skin adherable cradle unit.
`
`[0047] FIGS. 6a-c illustrate various optional locations of a two-part position detector.
`
`[0048] FIG. 7 illustrates an exemplary scheme of the components associated with the patch
`
`unit's position status setting and operation control.
`
`[0049] FIGS. 8a-c and 9a-b illustrate exemplary optical position detectors.
`
`[0050] FIGS. 10a-b illustrate an exemplary magnetic position detector.
`
`[0051] FIGS. 1la-b illustrate an exemplary electro-mechanical position detector.
`
`[0052] FIGS. 12a-b illustrate an exemplary electronic switch position detector.
`
`[0053] FIG. 13 is a flow chart of exemplary position settings and CPU-controlled patch
`
`operations.
`
`[0054] FIGS. 14a-c are flow charts of exemplary processes following position detector
`
`indications or inputted commands.
`
`[0055] FIGS. 15a-e illustrate an exemplary two-part patch unit provided with manual bolus
`
`buttons and a position detector.
`
`[0056] FIGS. 16a-d illustrate an exemplary two-part patch unit provided with operating buttons,
`
`a display and a position detector.
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`DETAILED DESCRIPTION OF THE INVENTION
`
`[0057] FIGS, la-b illustrate a device having a patch unit (10) capable of dispensing and/or
`
`sensing (hereinafter referred to generally as "patch" or "patch unit") and a remote control unit
`
`(40). In some embodiments, the patch unit (10) can include a single part (FIG. Ia) or two parts
`
`(FIG. Ib), e.g., reusable part (100) and disposable part (200).
`
`[0058] In some embodiments, fluid delivery can be programmed solely by the remote control
`
`unit (40) and/or by manual buttons (not shown) which could be provided on the patch unit (10).
`
`An embodiment of this arrangement is disclosed in our co-owned/co-pending International
`
`Patent Application No. PCT/IL0 8/00 1001, filed July 20, 2008, claiming priority to U.S.
`
`Provisional Patent Application No. 60/961,527, filed July 20, 2007, and titled "Manually
`
`Operable Portable Infusion Device", the disclosure of which is incorporated herein by reference
`
`in its entirety.
`
`[0059] FIGS. 2a-b illustrate another embodiment of the device having a patch unit (10) provided
`
`with operating buttons (12) (e.g., keypad) and a display (14). In some embodiments, fluid
`
`delivery programming can be earned out by the operating buttons (12). In other embodiments,
`
`the device can include also a remote control unit. The patch unit (10) can include a single part
`
`(FIG. 2a) or two parts (FIG. 2b), e.g., reusable part (100) and disposable part (200). In these
`
`embodiments, the operating buttons (12) and the display (14) can be located on the reusable part
`
`(100). An embodiment of this arrangement is disclosed in a co-owned, co-pending International
`
`Patent Application entitled "Portable Infusion Device with Means for Monitoring and
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`Controlling Fluid Delivery" " (Attorney Docket No. 30008-552), filed on an even date herewith,
`
`claiming priority to U.S. Provisional Patent Applications No. 60/963,148, filed August 1, 2007,
`
`and No. 61/004,019, filed November 21, 2007, both entitled "Portable Infusion Device with
`
`Means for Monitoring and Controlling Fluid Delivery", the disclosure of which is incorporated
`
`herein by reference in its entirety.
`
`[0060] In some embodiments, the device can include a cradle unit (20) that can be adhered to the
`
`skin of the patient, so that the patch unit (10) can be connected to and/or disconnected from the
`
`cradle unit (20) as desired. An embodiment of the device employing the cradle unit is disclosed
`
`in co-owned, co-pending U.S. Patent Application No. 12/004,837, and International Patent
`
`Application No. PCT/IL07001578, both filed December 20, 2007, and both claiming priority to
`
`U.S. Provisional Patent Application No. 60/876,679, filed December 22, 2006, the disclosures of
`
`which are incorporated herein by reference in their entireties.
`
`[0061] FIGS. 3a-b illustrate side and upper views (respectively) of an exemplary cradle unit (20).
`
`The cradle unit (20) can include the following elements:
`
`o Cradle base (300) - configured as a flat sheet with an adhesive layer
`
`facing the skin (5) and with anchoring latches (302, 304) on its upper side
`
`for connection and disconnection of the patch unit.
`
`o Well (310) - configured as a tubular protrusion emerging upwardly from
`
`the cradle base (300) to allow alignment with and appropriate connection
`
`of the patch unit. The well (310) constitutes a passageway through which a
`
`cannula (not shown) can be inserted into the patient's body for fluid (e.g.
`
`insulin) delivery and/or for analyte (e.g. glucose) sensing. The cradle unit
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`(20) can be configured to have more than one "well". For example, in case
`
`when two cannulae are employed, one for fluid delivery and the other for
`
`analyte sensing.
`
`[0062] FIG. 3c illustrates an exemplary embodiment of the cradle unit (20) having a cradle base
`
`(300) with anchoring latches (302, 304) and a well (310). Upon attachment of the cradle unit (20)
`
`to the patient's skin (5), a cannula (not shown) can be inserted into the subcutaneous
`
`compartment of the patient's body through the well (310) of the cradle unit (20). The insertion of
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`the cannula into the subcutaneous compartment can be carried out by a dedicated inserter (not
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`shown), e.g., an embodiment of which is disclosed in a co-owned, co-pending International
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`Patent Application No. PCT/IL08/000859 and U.S. Patent Application No. 12/215,219, filed
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`June 25, 2008, claiming priority to U.S. Provisional Patent Application No. 60/937,155, entitled
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`"Protector for Cannula and Penetrating Member Insertable in the Body of a Patient", and filed
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`June 25, 2007, and International Patent Application No. PCT/IL08/000860 and U.S. Patent
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`Application No. 12/215,255, filed June 25, 2008, claiming priority to U.S. Provisional Patent
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`Application No. 60/937,214, entitled "Insertion Device for Inserting a Cannula into a Body", and
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`filed June 25, 2007, disclosures of which are incorporated herein by reference in their entireties.
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`Following cannula insertion, a patch unit can be connected to the cradle unit, and fluid delivery
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`and/or analyte sensing can be established.
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`[0063] FIG. 4a illustrates the cradle unit (20) being adhered to the patient's skin (5). FIG. 4b
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`illustrates an exemplary connection of the patch unit (10) to the adhered cradle unit (20) (after
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`cannula insertion). FIG. 4c illustrates the patch unit (10) being connected to the cradle unit (20)
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`and ready for operation. FIG. 4d illustrate the patch unit (10) being disconnected from the cradle
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`unit (20).
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`Page 16 of 66
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`[0064] FIGS. 5a-d illustrate exemplary patch units that are configured to be attached to the
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`cradle unit (20). FIG. 5a illustrates an exemplary fluid delivery device having a cradle unit (20)
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`and a two-part dispensing patch unit (10) that employs a peristaltic pumping mechanism.
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`Rotation of a rotary wheel (110) and pressing of rollers (101) against a delivery tube (230)
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`periodically positively displaces fluid from a reservoir (220) into the delivery tube (230) by
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`virtue of a peristaltic motion. The fluid is then delivered via a cannula (330) into the
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`subcutaneous compartment (4) within the patient's body. An exemplary two-part dispensing
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`patch unit employing a peristaltic pumping mechanism is disclosed in co-pending, co-owned U.S.
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`Patent Application No. 11/397,1 15 and International Application No. PCT/IL06/001276, the
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`disclosures of which are incorporated herein by reference in their entireties. FIG. 5b illustrates an
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`exemplary fluid delivery device having a cradle unit (20) and a two-part dispensing patch unit
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`(10), which employs instead of a peristaltic pumping mechanism a syringe-type pumping
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`mechanism. A plunger (210) is displaced within a reservoir (220) and forces fluid towards the
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`cannula (330). An exemplary embodiment of this arrangement is disclosed in a co-owned, co-
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`pending International Patent Application No. PCT/IL08/000641, filed May 115 2008, claiming
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`priority to U.S. Provisional Patent Application No. 60/928,815, filed May 11, 2007, the
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`disclosure of which is incorporated herein by reference in its entirety. FIG. 5c illustrates an
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`exemplary analyte sensing device having a two-part sensing patch unit (10) and a cradle unit (20).
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`In an embodiment of FIG. 5c, an optical sensor for analyte sensing can be employed. One or
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`more optical means (106, 106') (e.g., reflectors) can be used for creating an optical path between
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`a light source (102) and a sample. In some embodiments, the optical path can be located in the
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`subcutaneous portion of the cannula (330). In some embodiments, the optical path terminates at a
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`light detector (104). An embodiment of this arrangement is disclosed in co-owned, co-pending
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`Page 17 of 66
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`U.S. Patent Application No. 11/989,678, filed January 28, 2008, and International Patent
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`Application No. PCT/IL07/001096, filed September 5, 2007, both claiming priority to U.S.
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`Provisional Patent Application No. 60/842,869, filed September 6, 2006, and U.S. Patent
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`Application No. 11/989,665, filed January 28, 2008 and International Patent Application No.
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`PCT/IL07/001 177, filed September 25, 2007, both claiming priority to No. 60/848,51 1 filed
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`September 29, 2006, the disclosures of which are incorporated herein by reference in their
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`entireties. FIG. 5d illustrates an exemplary dual function device having a cradle unit (20) and a
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`patch unit (10) that can be configured to dispense therapeutic fluid (e.g., insulin) and sense
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`analyte (e.g. glucose). This device can be configured to employ a single cannula shared for both
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`fluid delivery and analyte sensing. The dispensing and sensing functions can be independent
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`from one another, or as an alternative, the device may operate in a semi or fully closed-loop
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`mode. An embodiment of this arrangement is disclosed in a co-pending, co-owned U.S. Patent
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`Application No. 11/706,606, the disclosure of which is incorporated herein by reference in its
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`entirety.
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`[0065] Although basal delivery can be continuously administered to the patient, nevertheless in
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`practice it is often interrupted due to periodic patch unit disconnections, whether mandatory (e.g.,
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`during sauna and hot bath), voluntary (e.g., when going to the beach), or accidentally. According
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`to some embodiments, a dedicated position detector can be provided within the device for
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`detecting whether the patch unit is connected or disconnected. For example, the position detector
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`can be configured to generate a signal output, which can be received at the central processing
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`unit (CPU). The position detector's signal output can correspon