(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2006/0095014 A1
`Ethelfeld
`(43) Pub. Date:
`May 4, 2006
`
`US 20060.095 014A1
`
`(54) EXTERNAL INSERTER FOR
`TRANSCUTANEOUS DEVICE
`
`(75) Inventor: Erik Winkel Ethelfeld, Copenhagen
`(DK)
`Correspondence Address:
`NOVO NORDISK, INC.
`PATENT DEPARTMENT
`1OO COLLEGE ROAD WEST
`PRINCETON, NJ 08540 (US)
`(73) Assignee: Novo Nordisk A/S, Bagsvaerd (DK)
`
`(21) Appl. No.:
`(22) Filed:
`
`11/250,233
`Oct. 14, 2005
`Related U.S. Application Data
`
`(63) Continuation of application No. PCT/DK04/00335,
`filed on May 10, 2004.
`
`(30)
`
`Foreign Application Priority Data
`
`May 8, 2005 (EP)........................................ O3388O34.5
`
`Publication Classification
`
`(51) Int. Cl.
`(2006.01)
`A6M 3L/00
`(52) U.S. Cl. ...................... 604/506; 604/136; 604/93.01;
`604/180
`
`ABSTRACT
`(57)
`A medical device is provided, comprising a first unit and a
`releasably attachable second unit. The first unit comprises a
`mounting Surface adapted for application to the skin of a
`Subject, and a transcutaneous device comprising a distal
`pointed end adapted to penetrate the skin of the Subject,
`wherein the transcutaneous device has a first position in
`which the distal end is retracted relative to
`mounting
`Surface, and a second position in which the distal end
`projects relative to the mounting Surface. The second unit
`comprises actuatable driving means adapted to move the
`transcutaneous device from the first position to the second
`position when the driving means is actuated with the second
`unit attached to the first unit. By this arrangement the first
`unit can be applied to the skin of the Subject using the second
`unit as a gripping and handling means, whereafter the
`driving means can be actuated for insertion of the transcu
`taneous device.
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`May 4, 2006
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`EXTERNAL INSERTER FORTRANSCUTANEOUS
`DEVICE
`
`CROSS REFERENCE TO RELATED
`APPLICATIONS
`0001. This application is a continuation of International
`Application no. PCT/DK2004/000335 filed May 10, 2004
`and claims priority of European application no. 03388034.5
`filed May 8, 2005.
`0002 The present invention generally relates to the inser
`tion of transcutaneous access devices such as needles,
`needle-like members and cannulas. More specifically, the
`invention relates to insertion of a transcutaneous access
`device at a selected site within the body of a subject for
`Subcutaneous, intravenous, intramuscular or intradermal
`delivery of a drug to the Subject, the transcutaneous device
`being carried by a device comprising a mounting Surface
`adapted for application to the skin of the Subject. Especially,
`the invention relates to insertion of an infusion needle or
`cannula for the infusion of a drug, to insertion of a needle
`formed sensor, as well as to insertion of insertion needles for
`easy placement of a device Such as a sensor through the skin
`of a Subject.
`
`BACKGROUND OF THE INVENTION
`0003. In the disclosure of the present invention reference
`is mostly made to the treatment of diabetes by injection or
`infusion of insulin, however, this is only an exemplary use
`of the present invention.
`0004 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 and having an
`outlet in fluid communication with a hollow infusion needle,
`as well as expelling means for expelling a drug out of the
`reservoir and through the skin of the subject via the hollow
`needle. Such devices are often termed infusion pumps.
`0005 Basically, 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. Although more complex
`than traditional 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.
`0006 Addressing the above problem, several attempts
`have been made to provide a second class of drug infusion
`devices that are low in cost and convenient to use. Some of
`these devices are intended to be partially or entirely dispos
`able and may provide many of the advantages associated
`with an infusion pump without the attendant cost and
`inconveniencies, e.g. the pump may be prefilled thus avoid
`ing the need for filling or refilling a drug reservoir. Examples
`of this type of infusion devices are 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)), U.S. Pat. No. 5,527.288 (based on a
`gas generating pump), or U.S. Pat. No. 5,814,020 (based on
`a swellable gel) which all in the last decades have been
`
`proposed for use in inexpensive, primarily disposable drug
`infusion devices, the cited documents being incorporated by
`reference.
`0007. The disposable pumps generally comprise a skin
`contacting mounting Surface adapted for application to the
`skin of a subject by adhesive means, and with the infusion
`needle arranged such that in a situation of use it projects
`from the mounting surface to thereby penetrate the skin of
`the subject, whereby the place where the needle penetrates
`the skin is covered while the appliance is in use.
`0008. The infusion needle may be arranged to perma
`nently project from the mounting Surface Such that the
`needle is inserted simultaneously with the application of the
`infusion pump. Examples of this configuration can be found
`in U.S. Pat. Nos. 2,605,765, 4,340,048 and in EP 1 177802.
`Although this configuration provides a simple and cost
`effective solution, the actual user-performed piercing of the
`tissue with the needle is often problematic as people who are
`not experts in medicine are usually insufficiently practised to
`place such a needle correctly and they often suffer from a
`fear of the likely pain. Although not relating specifically to
`infusion pumps, U.S. Pat. No. 5,851,197 discloses an injec
`tor in which an infusion set comprising a skin-mountable
`Surface with a protruding needle can be inserted, the injector
`upon actuation driving the entire infusion set into contact
`with a skin portion whereby the needle is inserted.
`0009 Addressing the above problem, infusion pump
`devices have been proposed in which the pump device is
`supplied to the user with the needle in a retracted state, i.e.
`with the distal pointed end of the needle “hidden inside the
`pump device, this allowing the user to place the pump device
`on the skin without the possibility of observing the needle.
`When first the needle is hidden, at least some of the fear is
`overcome making the introduction of the needle in a second
`step less problematic. U.S. Pat. Nos. 5,858,001 and 5,814,
`020 disclose infusion devices of this type in which an
`infusion needle is arranged in an upper housing portion
`pivotably arranged relative to a base plate portion. In this
`way the user can introduce the needle by pressing the upper
`portion into engagement with the base plate portion.
`0010. To further reduce the fear and pain associated with
`the introduction of the needle, many recent pump devices
`have been provided with actuatable needle insertion means,
`which just has to be released by the user after which e.g.
`spring means quickly will advance the needle through the
`skin.
`0.011) For example, U.S. Pat. No. 5,957,895 discloses a
`liquid drug delivery device comprising a bent injection
`needle which is adapted to project through a needle aperture
`in the bottom surface of the housing in a situation of use. A
`movable needle carrier is disposed in the housing for car
`rying the injection needle and for causing the injection end
`of the needle to project through the needle aperture upon
`movement of the needle carrier.
`0012 U.S. Pat. No. 5,931,814 discloses an infusion
`device having a housing with a drug reservoir, an infusion
`needle (or cannula) communicating with the reservoir,
`means for inserting the needie, and pump means for dis
`charging the reservoir contents through the needle. The
`needle is fixed relative to the housing and projects beyond
`the lower skin-contacting Surface of the housing to the depth
`
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`
`required for injection. The needle is surrounded by a pro
`tective element which is moved by spring means from a first
`end position in which the protective device projects beyond
`the lower surface of the housing and beyond the needle to a
`second end position in which the protective device does not
`project beyond the underside of the casing. An advantage of
`this design is that the needle is arranged in a fixed position
`relative to the reservoir. WO 02/15965 discloses a similar
`infusion device in which a base plate member acts as a
`protecting element until an upper part of the device, to which
`the needle is fixed, is moved down into engagement with the
`base plate member.
`0013. In the devices disclosed in U.S. Pat. Nos. 5,957,895
`and 5.931,814 the needle is automatically inserted by the
`release of pre-tensioned spring means arranged within the
`devices, whereas in the device known from WO 02/15965
`the needle is inserted by the user actively moving the hidden
`needle. Although the automatic needle insertion means adds
`convenience for the user and may serve to overcome needle
`fear, such means also adds to the complexity and bulkiness
`of the device, the first issue adding to the cost of the device,
`the latter issue making the device less attractive and con
`venient to wear.
`0014 Before turning to the disclosure of the present
`invention, a different type of device relying on the insertion
`of a needle or needle-like structure will be described.
`0.015 Although drug infusion pumps, either disposable or
`durable, may provide convenience of use and improved
`treatment control, it has long been an object to provide a
`drug infusion system for the treatment of e.g. diabetes which
`would rely on closed loop control, i.e. being more or less
`fully automatic, such a system being based on the measure
`ment of a value indicative of the condition treated, e.g. the
`blood glucose level in case of insulin treatment of diabetes.
`0016 A given monitor system for measuring the concen
`tration of a given Substance may be based on invasive or
`non-invasive measuring principles. An example of the latter
`would be a non-invasive glucose monitor arranged on the
`skin Surface of a patient and using near-IR spectroscopy,
`however, the present invention is concerned with the intro
`duction of a transcutaneous device Such as a needle-formed
`sensor element.
`0017. The sensor may be placed subcutaneously being
`connected to external equipment by wiring or the Substance
`(fluid) to be analysed may be transported to an external
`sensor element, both arrangements requiring the placement
`of a subcutaneous component, the present invention address
`ing both arrangements. However, for simplicity the term
`“sensor is used in the following for both types of sensor
`elements.
`0018 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. Insertion devices for 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.
`0019 More specifically, U.S. Pat. No. 5,954,643 dis
`closes an insertion set comprising a mounting base Support
`
`ing a proximal end of a flexible thin film sensor, the sensor
`including a distal segment with sensor electrodes thereon
`which protrudes from the mounting base for transcutaneous
`placement, wherein the sensor distal segment is slidably
`carried by a slotted insertion needle fitted through the
`assembled base. Placement of the insertion set against the
`patient’s skin causes the insertion needle to pierce the skin
`to carry the sensor electrodes to the desired Subcutaneous
`site, after which the insertion needle can be slidably with
`drawn from the insertion set. A similar arrangement is
`known from U.S. Pat. No. 5,568,806.
`DISCLOSURE OF THE INVENTION
`0020 Having regard to the above-identified problems, it
`is an object of the present invention to provide an insertion
`means for a transcutaneous access device (in the following
`also termed a transcutaneous device) which would allow for
`easy and Swift, automatic insertion of the transcutaneous
`device, yet providing a compact transcutaneous device
`carrying device which can be manufactured cost effectively.
`0021 Correspondingly, a medical device is provided,
`comprising a first unit and a releasably attachable or
`attached second unit. The first unit comprises a mounting
`Surface adapted for application to the skin of a Subject, and
`a transcutaneous device comprising a distal pointed end
`adapted to penetrate the skin of the subject, wherein the
`transcutaneous device has a first position in which the distal
`end is retracted relative to the mounting Surface, and a
`second position in which the distal end projects relative to
`the mounting Surface. The second unit comprises actuatable
`driving means adapted to move the transcutaneous device
`from the first position to the second position when the
`driving means is actuated with the second unit attached to
`the first unit. By this arrangement the first unit can be applied
`to the skin of the subject where after the driving means can
`be actuated for insertion of the transcutaneous device.
`0022. Thus, a medical device is provided allowing for
`easy handling as a user can use the second unit to grip and
`handle the combined device during operation thereof, just as
`the second unit can be optimized for inserting the transcu
`taneous device with a speed and force which minimizes user
`discomfort as well as for ease of use during activation of the
`driving means as the drive means is no longer a part of the
`device which is carried by the patient and for which a
`compact design is of great importance. Correspondingly, as
`the first unit does not comprise any transcutaneous device
`drive means, the size can be further reduced and the design
`can be optimized for cost effective manufacture.
`0023 The transcutaneous device may be in the form of a
`pointed hollow infusion needle, a micro needle array, a
`pointed needle sensor, or a combination of a relatively
`flexible per se blunt cannula or sensor device with a pointed
`insertion needle may provide a pointed transcutaneous
`device, the insertion needle being retractable after insertion
`of the blunt portion of the transcutaneous device. The
`cannula is advantageously soft and flexible relative to the
`insertion needle which typically is a solid steel needle. In the
`disclosure of the present invention as well as in the descrip
`tion of the exemplary embodiments, reference will mostly
`be made to a transcutaneous device in the form of an
`infusion needle.
`0024. The first and second units may be releasably
`attached to each other by any Suitable means allowing the
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`
`combined device initially to be handled and applied against
`the skin as a unitary device, yet allowing the units to be
`separated by the user, e.g. by a frictional fit, releasable
`gripping means with or without locking means, or by
`breakable attachment means such as adhesives or welding.
`The mounting Surface may be held in contact with the skin
`Surface by use of additional means (e.g. adhesive bandages),
`however, preferably the mounting Surface comprises adhe
`sive means for attaching the first unit directly to the skin of
`the subject.
`0.025 The driving means may in the form of spring
`means which is arranged in an activated State when Supplied
`to the user or can be arranged in an activated State by the
`user, the second unit comprising trigger means for releasably
`retaining the spring means in the actuated State (e.g. com
`pressed or bend), wherein the trigger means is operable to
`release the spring means for moving the needle from the first
`position to the second position. It should be emphasized that
`the activated State not necessarily is a stable state in which
`the spring means can be left, but a state which may require
`that an actuation input (e.g. a force applied by the user) is
`upheld, i.e. the spring means may resume an initial state if
`the actuation input is removed. The spring means may be
`any elastically compressible or deformable driving means,
`e.g. metal or polymer member, elastomeric foam or gas.
`0026. When the driving means comprises spring means,
`the second unit may comprise actuation means actuatable
`from a first condition through an intermediate condition to a
`second condition, whereby actuation of the actuation means
`from the first to the intermediate condition causes activation
`of the driving means, and actuation of the actuation means
`from the intermediate to the second condition causes release
`of the activated spring means thereby moving the needle
`from the first position to the second position. By this
`arrangement the actuation means may serve as a user
`interface Such that the user will not have to directly engage
`the spring means just as the user input may be transformed,
`e.g. from one type of movement to another.
`0027 Advantageously the actuation means comprises an
`actuating element (e.g. an element which can be gripped or
`actuated by the user) which is moved from a first position
`through an intermediate position to a second position, pref
`erably corresponding to a substantially non-composite
`movement (e.g. a unidirectional linear or rotational move
`ment and which may be with or without an intermediate
`lockable state). In an alternative arrangement actuation of
`the actuation means from the first through the intermediate
`to the second condition is accomplished by moving two
`actuation elements against each.
`0028. The second unit may be provided with an interior
`space for at least partially accommodating the first unit and
`an opening through which the first member can be moved
`when detached from the second unit, the mounting Surface
`facing away from the interior space. By the term partially is
`defined that a portion of the first unit may project from the
`opening of the cavity. In this way the second unit may serve
`in partial as a container for the first unit. In order to fully
`provide a container for the first unit, the second unit com
`prises a circumferential portion Surrounding the opening,
`and to which portion a seal member is releasably attached,
`thereby providing a closed space for the first unit. In
`exemplary embodiments when it is desirable to sterilize the
`
`entire first unit, the seal member may be penetratable for
`sterilizing gases (e.g. ethylene oxide or dry steam), yet being
`non-penetratable for germs. By this arrangement the first
`unit can serve as a packaging for the second unit, this further
`reducing costs as well as overall size. Advantageously, the
`circumferential portion defines a general plane, this allowing
`e.g. foil-, film- or paper-like materials to be used as sealing
`members.
`0029 Advantageously, the second unit comprises a hous
`ing defining the interior space, this allowing the driving
`means to be arranged between an upper portion of the first
`unit (i.e. opposite the mounting Surface) and a portion of the
`housing. In this configuration the housing may serve as the
`user interface providing the above-discussed actuation
`means for the driving means.
`0030 The mounting surface is advantageously generally
`planar and arranged Substantially corresponding to the gen
`eral plane. When such a mounting Surface comprises adhe
`sive means for attaching the first unit to the skin of the
`Subject, the seal member may advantageously be releasably
`attached to the adhesive means, this arrangement avoiding
`the use of a separate releasable liner on the adhesive. In case
`a separate liner is provided, the liner and the seal member
`may be arranged Such that pealing off the seal member
`automatically result in the liner being peeled of, this irre
`spective of the position of the mounting Surface. The term
`'generally planar is meant to include embodiments in
`which the mounting Surface is somewhat concave or convex.
`0031. The needle may be introduced through or into the
`skin at any desired angel relative to the mounting Surface
`(and thus the skin Surface), e.g. generally perpendicular to
`the mounting Surface.
`0032. As indicated above, the present invention may be
`utilized in combination with a number of different types of
`devices.
`0033 For example, for a medical device as described
`above the needle may be in the form of a hollow infusion
`needle, the first unit further comprising a reservoir adapted
`to contain a liquid drug and comprising in a situation of use
`an outlet in fluid communication with the infusion needle, as
`well as expelling means for expelling a drug out of the
`reservoir and through the skin of the subject via the hollow
`needle. The reservoir and the expelling means may be of any
`Suitable type, e.g. of any of the types described in the
`above-referred documents.
`0034. The transcutaneous device may also be in the form
`of a needle sensor comprising sensor means capable of being
`influenced by a body Substance and producing a signal
`corresponding thereto. The sensor means may be of any
`Suitable type, e.g. of any of the types described in the
`above-referred documents.
`0035) In a further embodiment the first unit comprises a
`transcutaneous device comprising a transcutaneous member
`(e.g. a soft cannula or a sensor) in combination with a
`co-axially or co-linearly arranged pointed insertion needle,
`the insertion needle and the transcutaneous member being
`arranged to be simultaneously moved by the driving means
`from their respective first position to their respective second
`position when the driving means is actuated, wherein the
`insertion needle is arranged to be moveable away from the
`distal end of the transcutaneous member when the cannula
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`and the insertion needle have been moved to their second
`position. Advantageously the insertion needle is attached to
`or gripped by the driving means, this allowing the insertion
`needle to be removed from the first unit together with the
`second unit.
`
`0036). In a further aspect of the invention, a method of
`applying a medical device to a skin Surface of a Subject is
`provided, the method comprising the steps of: (a) providing
`a medical device having a first unit and a releasably attached
`second unit, wherein the first unit comprises a generally
`planar mounting Surface comprising adhesive means for
`adhering the first unit to the skin of the Subject, a transcu
`taneous device comprising a distal pointed end adapted to
`penetrate the skin of the Subject, wherein the transcutaneous
`device has a first retracted position relative to the second
`unit, and a second position in which the distal end projects
`relative to the second unit. The second unit comprises an
`interior space accommodating the first unit and having an
`opening through which the first unit can be moved when
`detached from the second unit, the second unit having a
`circumferential portion defining a general plane and Sur
`rounding the opening, the mounting Surface being arranged
`interiorly in respect of the general plane or Substantially
`corresponding to the general plane, a seal member releasably
`attached to the circumferential portion, thereby providing a
`closed space for the first unit, and actuatable driving means
`adapted to move the transcutaneous device from the first
`position to the second position when the driving means is
`actuated with the second unit attached to the first unit. The
`method comprises the further steps of (b) removing the seal
`member, (c) arranging the medical device in contact with the
`skin of the Subject, (d) actuating the driving means thereby
`moving the transcutaneous device into the skin of the
`Subject, and (e) removing the second unit from the first unit.
`0037 Depending on whether the mounting surface ini
`tially is positioned interiorly in respect of the general plane
`or Substantially corresponding to the general plane, the
`adhesive surface will be placed in contact with the skin
`surface either when the device is actuated (thereby moving
`the first unit towards the skin) or when the device is initially
`placed on the skin Surface.
`0038. 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 indude pharmaceu
`ticals such as peptides, proteins (e.g. insulin, insulin ana
`logues, C-peptide), and hormones, biologically 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 embodi
`ments reference will be made to the use of insulin. Corre
`spondingly, the term 'subcutaneous' infusion is meant to
`encompass any method of transcutaneous delivery to a
`subject. Further, the term needle (when not otherwise speci
`fied) defines a piercing member (including an array of micro
`needles) adapted to penetrate the skin of a Subject.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`0039. In the following the invention will be further
`described with references to the drawings, wherein
`0040 FIG. 1 shows in a perspective view a first embodi
`ment of a medical device gripped by a user corresponding to
`a first state of use,
`0041
`FIG. 2A shows in a perspective view the medical
`device of FIG. 1 gripped by the user corresponding to a
`second State of use,
`0.042 FIG. 2B shows the needle device of FIG. 1A with
`an outer portion cut away,
`0.043 FIG. 2C shows the first unit of the needle device
`of FIG. 1A,
`0044 FIGS. 3A-3C shows a third state of use corre
`sponding to FIGS. 2A-2C.
`004.5 FIGS. 4A-4C shows a fourth state of use corre
`sponding to FIGS. 2A-2C.
`0046 FIG. 5 shows in a perspective view the medical
`device of FIG. 1 gripped by the user corresponding to a fifth
`state of use,
`0047 FIG. 6A shows in cross-section a second embodi
`ment of a medical device,
`0048 FIG. 6B shows an alternative configuration of the
`second embodiment,
`0049 FIG. 7 shows in cross-section a third embodiment
`of a medical device,
`0050 FIG. 8A shows in cross-section a fourth embodi
`ment of a medical device,
`0051 FIG.8B shows a variant of the fourth embodiment,
`0052 FIG. 9 shows in cross-section a fifth embodiment
`of a medical device,
`0053 FIG. 10 shows in cross-section a sixth embodiment
`of a medical device,
`0054 FIGS. 11A-11D shows different expelling means
`suitable for use with the invention,
`0.055 FIGS. 12A-12C shows different states of use for a
`sensor device, and
`0056 FIGS. 13 A-13B show in cross-sections a further
`embodiment of a medical device.
`0057. In the figures like structures are identified by like
`reference numerals.
`
`DESCRIPTION OF EXEMPLARY
`EMBODIMENTS
`0.058 When in the following terms as “upper” and
`“lower”, “right” and “left”, “horizontal” and “vertical” or
`similar relative expressions are used, these only refer to the
`appended figures and not to an actual situation of use.
`0059 FIGS. 1-4 show in schematic representations per
`spective views of different states of use of a medical device
`in accordance with the invention. Correspondingly, the
`configuration of the different structures as well as there
`relative dimensions are intended to serve illustrative pur
`poses only.
`
`Page 19 of 25
`
`

`

`US 2006/009SO 14 A1
`
`May 4, 2006
`
`0060 More specifically, FIG. 1 shows a first embodiment
`of a medical device 100 gripped by a user. The medical
`device comprises a second unit 110 with a housing defining
`an interior space, and a first unit 150 releasably attached
`within the interior space. In the following the second unit
`will also be termed the “inserter'. The housing comprises a
`main portion with a lower opening Surrounded by a circum
`ferential flange 111 extending away from the housing, the
`flange having a lower Surface 112 defining a general plane
`for the medical device. The housing further comprises first
`and second upwardly protruding actuation members (or
`handling members) 120, 130 arranged on the upper portion
`of the housing opposite the opening, the actuation members
`comprising ribbed portions 121, 131 allowing for easy
`gripping by a user, e.g. using the first and second fingers as
`shown. The first unit is in the form of a needle device (e.g.
`an infusion device or a sensor device) comprising an adhe
`sive mounting surface 151 adapted for application to the
`skin of a Subject, the mounting Surface being generally
`planar and arranged Substantially corresponding to the gen
`eral plane. The needle device further comprises a needle (not
`shown) having a distal pointed end adapted to penetrate the
`skin of the subject, the needle having a first position in which
`the distal end is retracted relative to the mounting Surface,
`and a second position in which the distal end projects
`relative to the mounting Surface.
`0061 The inserter further comprises a foil member 113
`which, when Supplied to the user, is attached to the circum
`ferential lower surface of the flange 111 thereby providing a
`sealed cavity in which the needle device is arranged. The foil
`member is further releasably attached to the adhesive means
`arranged on the mounting Surface of the needle device.
`When the user intends to use the needle device, the foil
`member is peeled away as show in FIG. 1 whereafter the
`medical device 100 can be placed on a skin portion of the
`user (see FIG. 2A), the needle device thereby adhesively
`engaging the skin.
`0062 Corresponding to the invention, the inserter further
`comprises actuatable driving means adapted to move the
`needle from the first position to the second position when the
`driving means is actuated with the second unit attached