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`(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
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`(19) World Intellectual Property Organization
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`International Bureau
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`111111 1111111111 IIIIII IIIII 11111111111111111111 IIIII IIIII IIIII IIIII IIIII IIII 1111111111111111111
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`( 43) International Publication Date
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`24 December 2008 (24.12.2008)
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`PCT
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`(10)International Publication Number
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`WO 2008/155377 Al
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`(51)International Patent Classification:
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`A61M 5/158 (2006.01)
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`(21)International Application Number:
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`PCT /EP2008/0577 69
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`(81)Designated States (unless otherwise indicated, for every
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`kind of national protection available): AE, AG, AL, AM,
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`AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, CA,
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`CH, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE,
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`EG, ES, Fl, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID,
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`IL, IN, IS, JP, KE, KG, KM, KN, KP, KR, KZ, LA, LC,
`(22)International Filing Date:19 June 2008 (19.06.2008)
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`LK, LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN,
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`MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PG, PH,
`English
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`PL, PT, RO, RS, RU, SC, SD, SE, SG, SK, SL, SM, SV,
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`SY, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN,
`English
`ZA, ZM,ZW.
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`(25)Filing Language:
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`(26)Publication Language:
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`(30)Priority Data:
`(84)Designated States (unless otherwise indicated, for every
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`60/945,17220 June 2007 (20.06.2007) US kind of regional protection available): ARIPO (BW, GH,
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`GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM,
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`ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM),
`(71)Applicant (for all designated States except US): UN
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`OMEDICAL A/S [DK/DK]; Birkerpd Kongevej 2,
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`European (AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, Fl,
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`DK-3460 Birkerpd (DK).
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`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,
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`CI, CM, GA, GN, GQ, GW, ML, MR, NE, SN, TD, TG).
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`(72)Inventor; and
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`(75)Inventor/Applicant (for US only): HASTED, Spren,
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`Bo [DK/DK]; Rosenva:ngets Alie 27A, 2. tv., DK-2100
`Published:
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`Kpbenhavn 0 (DK).
`with international search report
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`before the expiration of the time limit for amending the
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`claims and to be republished in the event of receipt of
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`7, DK-2900 Hellerup (DK).
`amendments
`==---------------------------------------------
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`ONLY ONECOMPRISING (54) Title: CANNULA INSERTION DEVICE W ITH AUTOMATIC NEEDLE RETRACTION
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`and automatic insertion unit assuring and a spring an insertion needle set comprises Q (57) Abstract: The inserter for an infusion
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`0 automatic retraction of the insertion needle. T he inserter for a medical device comprises - a housing (6), - a first body (1) which
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`of insertion, - a second body (4) in the direction penetrating means (3) pointing and comprising housing M is movable relative to the
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`the first body (1) and the secondmeans (5) which move respectively (6) and -driving housing 0 which is also movable relative to the
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`of insertion and movesfirst body (1) in the direction means (5) moves the the driving (6) wherein :, body (4) relative to the housing
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`direction. different from the insertion ;;, the second body (4) in a direction
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`Page 1 of 18
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`WO 2008/155377 PCT/EP2008/057769
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`CANNULA INSERTION DEVICE WITH AUTOMATIC NEEDLE RETRACTION COMPRISING ONLY ONE
`SPRING
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`The invention relates to an inserter for a medical device e.g. an infusion set
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`for intermittent or continuous administration of a therapeutical substance,
`5 such as e.g. insulin. The inserter comprises an insertion needle and a spring
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`unit assuring automatic insertion and automatic retraction of the insertion
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`needle.
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`Background of the invention
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`10 It is known to construct inserters for infusion sets which hides and protects
`the insertion needle before insertion and which retracts the insertion needle
`after penetration of the patients skin and thereafter hides and protects the
`insertion needle.
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`Such a device is known from EP 1.762.259. The inserter according to this
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`15 document comprises a needle hub comprising an insertion needle and two
`spring units assuring automatic insertion and automatic retraction of the
`insertion needle. Although the design of the device is compact and user
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`friendly the mechanism is relatively complex as two spring units are used in
`order to make the device work correctly.
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`20 The present invention provides both protection of the insertion needle before
`insertion and after retraction and at the same time the inserter device is of a
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`simple construction which only needs one spring unit.
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`Description of invention
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`25 The object of the invention is to provide a simple, non-expensive inserter for
`an infusion device which inserter would be easy and safe for the user to
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`handle during use and safe to dispose of after use.
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`Page 2 of 18
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`WO 2008/155377 PCT/EP2008/057769
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`The invention concerns an inserter for inserting a medical device comprising
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`a housing, a first body which is movable relative to the housing and
`comprising penetrating means pointing in the direction of insertion, a second
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`body which is also movable relative to the housing and driving means which
`5 move respectively the first body and the second body relative to the housing
`wherein the driving means moves the first body in the direction of insertion
`and moves the second body in a direction different from the insertion
`direction.
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`10 In one embodiment the driving means first move the first body in the direction
`of insertion and then moves the second body in the direction different from
`the insertion direction. The driving means can comprise a single spring unit
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`which could be a cluster of several springs or a single spring unit, e.g. a
`coiled spring. The spring unit of this one embodiment can work by first
`15 expanding in the insertion direction and then expanding in the direction
`different from the insertion direction. This direction different from the insertion
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`direction can be in an angle of 180° ± 5° to the insertion direction.
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`In one embodiment the inserter device can be provided with first locking
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`20 means which locking means can keep the first body in a chosen retracted
`position in relation to the housing while the driving means are biased i.e. the
`driving means posses stored or potential energy. These first locking means
`can comprise a protruding part on the first body which interacts with an
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`opening in the housing.
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`25
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`In one embodiment the inserter is provided with second locking means which
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`second locking means can keep the second body in a chosen forward
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`position in relation to the housing while the driving means are biased i.e. the
`driving means posses potential energy, e.g. the second locking means
`30 comprises an inwardly protruding part of the housing which interacts with a
`distally turned surface of the second body.
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`Page 3 of 18
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`WO 2008/155377 PCT/EP2008/057769
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`According to one embodinnent the inserter comprises means for locking the
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`penetrating means to the second body while the second body is moving from
`a forward to a retracted position in relation to the housing.
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`The medical device used with the inserter device can be e.g. an infusion part
`for administrating medication or a sensor device for measuring values e.g. of
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`the blood or a simple port/gateway for administering medication by a syringe
`or the like.
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`10
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`The invention also relates to a process for positioning a medical device on
`the skin of a patient which process comprises the following steps:
`a) removing any packing and preparing the skin adhesion of the medical
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`device;
`15 b) placing the proximal end of the inserter against the skin of the patient or
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`against a pre-positioned pad;.
`c) unreleasing a first set of locking means (9) which will bring a first body (1)
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`to reach a forward position and cause a proximal surface of the medical
`device to reach the surface it is to be placed on;
`20 d) unreleasing a second set of locking means (11) which will result in that a
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`second body (4) including parts locked to the second body (4) are distanced
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`from the medical device which is left on the patients skin;
`e) removing the inserter from the position while the medical device is left in
`the position.
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`25
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`Description of the drawings
`The invention is explained in greater detail below with reference to the
`accompanying drawings wherein preferred embodiments of the invention is
`shown.
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`Page 4 of 18
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`WO 2008/155377 PCT/EP2008/057769
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`Fig. 1 shows a cut-through view of an embodinnent of a device according to
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`the invention. The embodinnent is in a first state where the penetrating
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`mennber is retracted and the spring unit is tightened.
`Fig. 2 shows the same embodiment as fig. 1 in the same state but in a view
`5 which is perpendicular to the view of fig. 1.
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`Fig. 3 shows the same embodiment as fig. 1 and 2 in a second state where
`the penetrating member is in a forward position and the spring unit in a semi-
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`tightened state.
`Fig. 4 shows the same embodiment as the previous figures in a third state
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`10 where the penetrating member is in a retracted position; the medical device
`is left on the skin of the patient and the spring unit in a non-tightened state.
`Fig. 5 shows an exploded view of the same embodiment as the previous
`figures.
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`15 The device illustrated in fig. 1 comprises a carrier body 1 for a medical device
`to be inserted, a needle hub 2 comprising a penetrating member 3, a
`movable part 4, a spring unit 5 and a housing 6. The spring unit 5 is tightened
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`or biased in the
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`20 The medical device can be al sorts of devices which for some reason needs
`to be placed sub- or transcutaneously on a patient for a shorter or longer
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`time. In the embodiment illustrated in fig. 1-5 the medical device is a port-
`device. A port-device is a device which is placed on a user's skin for a period
`of upto three days and replaces numerous injections normally made be a
`25 syringe. The medical device could instead be an infusion part which device is
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`also normally situated on the patient for several days and an infusion part
`has means for connecting it to a delivery device e.g. for delivering insulin. An
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`infusion part can e.g. provide an optimized administration of a therapeutic
`substance as it allows very small doses to be transferred often. The medical
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`30 device can also be a sensor device provided with a subcutaneously placed
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`Page 5 of 18
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`WO 2008/155377 PCT/EP2008/057769
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`sensor which is in contact with the patient's blood and able to register desired
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`elements in the blood e.g. the sugar level.
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`The port-device shown in the figures comprises a body 7 having a through
`5 going opening and a cannula 8 made of a soft and flexible material.
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`Fig. 2 shows the same embodiment in the same state as fig. 1 but from an
`angle perpendicular to the view angle illustrated in fig. 1. From this angle it is
`possible to see how the carrier body 1 is provided with two protruding locking
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`10 parts 9 which are positioned at the end of each a flexible arm 10. The
`protruding locking parts 9 fit into corresponding openings in the stationary
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`housing 6 and lock the carrier body 1 in a retracted position before use. The
`spring unit 5 is biased and pushes against the locked carrier body 1
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`(downwards on fig. 2) and the movable part 4 (upwards on fig. 2). When a
`15 user puts pressure on the opposite positioned pressure points 13 which are
`corresponding to the opposite positioned protruding parts 9, the protruding
`parts 9 are disengage from the openings in the housing 6 and the spring unit
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`5 will push the carrier body 1 downwards as the movable part 4 is still locked
`in relation to the housing 6 with secondary locking means.
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`20
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`The secondary locking means have the form of a longitudinal cut-out 11
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`having the length L. The longitudinal cut-out is fixed to the housing 6 by thin
`parts of material close to the middle section, the fastening parts have the
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`length/width /"and are symmetrically placed on each side of the cut-out 11.
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`25 The length/width of the fastening parts are less than 10% of the total length
`of the cut-out 11, in the present embodiment the length/width of the fastening
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`parts are approximately 6% of the length of the cut-out 11. The fastening
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`parts are so relatively thin that it is possible to pivot the free ends of the cut-
`out 11 around the axis formed by the fastening parts. A first of the free ends
`30 12 is provided with means which will make the user recognize these parts of
`the cut-out 11 as pressure points. In the embodiment in fig. 2 these means
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`Page 6 of 18
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`comprises a series of flutes which can be felt by the user and recognized as
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`a pressure point. When the user put pressure on the two opposite positioned
`first free ends 12, the first free ends 12 move towards the centre of the
`device while the second free ends moves outwards away from the centre of
`5 the device. The second free ends are provided with inwardly protruding parts
`14 which are engaged with the edge 15 of an opening in the movable part 4.
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`Fig. 3 shows two perpendicular views of the inserter device, the view C-C are
`similar to fig. 1 and the view D-D is similar to fig. 2. The spring unit 5 of the
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`10 embodiment in fig. 3 is in a semi-biased state, i.e. the spring unit 5 is
`released from the first lock made between the protruding parts 9 and the
`housing 6 and as a result of the releasing of the first locking means the
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`cannula 8 of the medical device has been inserted subcutaneously in the
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`patient. Also the carrier body 1 and the needle hub 2 has moved in relation to
`15 the movable part 4, the carrier body 1 has been distanced from the movable
`part 4 while the needle hub 2, which moves together with the carrier body 1,
`is moved from a surface position to an inner position in relation to the
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`movable part 4 which makes it possible for the user to register that the
`penetrating member 3 is now in an inserted position.
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`20
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`Fig. 4 shows the same perpendicular views of the same embodiment of the
`inserter device as shown in fig. 3, but the spring unit 5 of the embodiment in
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`fig. 4 is in an un-biased state, i.e. the spring unit 5 is also released from the
`second lock made between the inwardly protruding parts 14 of the housing 6
`25 and the movable part 4 and as a result of the releasing of the second locking
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`means the needle hub 2 together with the carrier body 1 is retracted from the
`patient. The user can observe this as the movable part 4 is raised in relation
`to the stationary housing 6.
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`30 Fig. 5 shows the same embodiment as fig. 1-4 but in an exploded view where
`the parts are partly separated in order to show the individual parts in a three-
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`Page 7 of 18
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`dimensional way and how the individual parts relate to each other. The parts
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`have the same reference numbers as in fig. 1-4.
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`The inserter device is normally delivered to the user joined with the medical
`5 device in a sterile packing which has to be removed before use. Either the
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`medical device is provided with a mounting pad, that is a mounting pad is
`unreleasably fastened to the proximal side of the medical device, or a
`mounting pad is provided in a separate sterile packing and placed on the skin
`of the patient at a suitable insertion place before the medical device is
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`10 inserted. If the mounting pad is unreleasably fastened to the medical device it
`will normally be necessary to remove a release layer from the adhesive
`surface of the mounting pad before using the inserter device.
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`After the sterile packing is removed and either the release layer is removed
`15 or the separate mounting pad is positioned, the inserter device is ready for
`insertion of the medical device.
`- The proximal end of the inserter device is then placed against the skin of
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`the patient or against the pre-positioned mounting pad; the proximal end of
`the inserter device is the end towards which the sharp end of the penetrating
`20 member points.
`- Then the user puts pressure on the oppositely positioned pressure points
`13 which will unlock the first locking means, i.e. the protruding locking parts
`9. The unlocking of the first locking means result in the carrier body 1
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`including the medical device and the needle hub 2 being moved forward at
`25 the speed provided by the spring unit 5. The movement is stopped as the
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`medical device touches the skin of the patient as further extension of the
`spring unit 5 is then prevented.
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`- Then the user puts pressure on the oppositely positioned pressure points
`12 which unlocks the second locking means, i.e. the pivotally fastened cut-
`30 out 11. The unlocking of the second locking means result in the movable part
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`Page 8 of 18
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`WO 2008/155377 PCT/EP2008/057769
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`8
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`4 including the needle hub 2 being pushed away from the carrier body 1 and
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`the medical device which is left inserted into the patients skin.
`- The inserter device can now be removed from the insertion position while
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`the medical device is left in the inserted position.
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`Page 9 of 18
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`WO 2008/155377 PCT/EP2008/057769
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`Claims:
`1. An inserter device for a medical device comprising
`- a housing (6),
`- a first body (1) which is movable relative to the housing and comprising
`5 penetrating means (3) pointing in the direction of insertion,
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`- a second body (4) which is also movable relative to the housing (6) and
`- driving means (5) which move respectively the first body (1) and the second
`body (4) relative to the housing (6)
`characterized in that the driving means (5) moves the first body (1) in the
`10 direction of insertion and moves the second body (4) in a direction different
`from the insertion direction.
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`2. An inserter according to claim 1, characterized in that the driving means
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`(5) first move the first body (1) in the direction of insertion and then moves
`15 the second body (4) in the direction different from the insertion direction.
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`3. An inserter according to claim 2, characterized in that the driving means
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`(5) comprise a single spring unit (5).
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`20 4. An inserter according to claim 3, characterized in that the spring unit (5)
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`is a coiled spring.
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`5. An inserter according to claim 3 or 4, characterized in that the spring unit
`(5) first expand in the insertion direction and then expand in the direction
`25 different from the insertion direction.
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`6. An inserter according to any of the claim 1-6, characterized in that the
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`direction different from the insertion direction is in an angle of 180° ± 5° to the
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`insertion direction.
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`30
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`Page 10 of 18
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`10
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`7. An inserter according to any of the claims 1-6, characterized in that the
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`inserter device is provided with first locking means (9) which locking means
`can keep the first body (1) in a chosen retracted position in relation to the
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`housing (6) while the driving means (5) are biased.
`
`5
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`8. An inserter according to claim 7, characterized in that the first locking
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`means comprises a protruding part (9) on the first body (1) which interacts
`with an opening in the housing (6).
`
`10 9. An inserter according to any of claims 1 -7, characterized in that the
`inserter is provided with second locking means (11, 14) which second locking
`means can keep the second body (4) in a chosen forward position in relation
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`to the housing (6) while the driving means (5) are biased.
`
`15 10. An inserter according to any of claims 9, characterized in that the
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`second locking means comprises an inwardly protruding part (14) of the
`housing (6) which interacts with a distally turned surface (15) of the second
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`body (4).
`
`20 11. An inserter according to any of the claims 1 -10, characterized in that the
`inserter comprises means for locking the penetrating means (3) to the
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`second body (4) while the second body (4) is moving from a forward to a
`retracted position in relation to the housing (6).
`
`25 12. An inserter according to any of the preceding claims, characterized in
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`that the medical device is an infusion part for administrating medication or a
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`sensor device for measuring values e.g. of the blood or a simple
`port/gateway for administering medication by a syringe or the like.
`
`Page 11 of 18
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`WO 2008/155377 PCT/EP2008/057769
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`11
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`13. Process for positioning a medical device on the skin of a patient
`characterized in that the process comprises the following steps:
`a) removing any packing and preparing the skin adhesion of the medical
`
`device;
`5 b) placing the proximal end of the inserter against the skin of the patient or
`
`against a pre-positioned pad;.
`c) unreleasing a first set of locking means (9) which will bring a first body (1)
`
`to reach a forward position and cause a proximal surface of the medical
`device to reach the surface it is to be placed on;
`10 d) unreleasing a second set of locking means (11) which will result in that a
`
`second body (4) including parts locked to the second body (4) are distanced
`from the medical device which is left on the patients skin;
`e) removing the inserter from the position while the medical device is left in
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`the position.
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`Page 12 of 18
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`PCT/EP2008/057769
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`1/3
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`* A
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`i
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`A-A
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`Fig. 1
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`A
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`Page 13 of 18
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`PCT/EP2008/057769
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`2/3
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`Fig. 4
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`Page 14 of 18
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`WO 2008/155377
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`PCT/EP2008/057769
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`3/3
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`Page 15 of 18
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`
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`INTERNATIONAL SEARCH REPORT
`
`International application No
`PCT/EP2008/057769
`
`A. CLASSIFICATION OF SUBJECT MATTER
`INV. A61M5/158
`
`According lo International Patent Classification (IPC) or to both national classification and IPC
`
`B. FIELDS SEARCHED
`Minimum documentation searched (classification system followed by classification symbols)
`A61M
`
`Documentation searched other than minimum documentation to the extent that such documents are included in the fields searched
`
`Electronic data base consulted during the international search (name of data base and, where practical, search terms used)
`EPO-Internal, WPI Data
`
`C. DOCUMENTS CONSIDERED TO BE RELEVANT
`
`Category' Citation of document, with indication, where appropriate, of the relevant passages
`
`Relevant to claim No.
`
`WO 2006/061354 A (NOVO NORDISK AS [DK];
`ETHELFELD ERIK WINKEL [DK]; SCHMIDT
`NICOLAI MICH) 15 June 2006 (2006-06-15)
`paragraphs [0104], [0105]; figures
`25A-25D
`
`US 2004/158207 Al (HUNN MARCEL [CH] ET AL)
`12 August 2004 (2004-08-12)
`paragraphs [0082] - [0089]; figures 13-18
`
`US 2007/093754 Al (M0GENSEN LASSE W [DK]
`ET AL) 26 April 2007 (2007-04-26)
`figures 1-5
`
`1-12
`
`1-12
`
`1,2,6-12
`
`• Further documents are listed in the continuation of Box C.
`
`* Special categories of cited documents :
`
`"A" document defining the general stale of the art which is not
`considered lo be of particular relevance
`'£• earlier document but published on or after the international
`filing date
`•L" document which may throw doubts on priority claim(s)or
`which is cited to establish the publication date of another
`citation or other special reason (as specified)
`'O* document referring to an oral disclosure, use, exhibition or
`other means
`'P' document published prior to the international filing dale but
`later than the priority date claimed
`
`m See patent family annex.
`
`"T* laler document published after the international filing date
`or priority date and not in conflict with the application but
`cited to understand the principle or theory underlying the
`invention
`"X" document of particular relevance: the claimed invention
`cannot be considered novel or cannot be considered to
`involve an inventive step when the document is taken alone
`'Y* document of particular relevance; the claimed invention
`cannot be considered to involve an inventive step when the
`document is combined with one or more other such docu-
`ments, such combination being obvious to a person skilled
`in the art
`'&• document member of the same patent family
`
`Date of the actual completion of the International search
`
`Date of mailing of the international search report
`
`5 November 2008
`
`Name and mailing address of the ISA/.
`European Patent Office. P.B. 5818 Patenllaan 2
`NL - 2280 HV Rijswijk
`Tel. (+31-70)340-2040,
`Fax: (+31-70)340-3016
`
`Fomn PCT/ISA/210 (second sheet) (April 2005)
`
`13/11/2008
`
`Authorized officer
`
`Krassow, Heiko
`
`Page 16 of 18
`
`
`
`INTERNATIONAL SEARCH REPORT
`
`International application No.
`PCT/EP2008/057769
`
`Box No. II Observations where certain claims were found unsearchable (Continuation of item 2 of first sheet)
`
`This international search report has not been established in respect of certain claims under Article 17(2)(a) for the following reasons:
`
`1. \y~\ ClaimsNos.: 13
`because they relate to subject matter not required to be searched by this Authority, namely:
`Rule 39.1(iv) PCT - Method for treatment of the human or animal body by
`surgeryThe method claimed Implicitly comprises inserting a needle and cannula
`arrangement into the skin of a patient and is therefore to be considered a
`surgical method.
`2. Claims Nos.:
`because they relate to parts of the international application that do not comply with the prescribed requirements to such
`an extent that no meaningful international search can be carried out, specifically:
`
`3. Claims Nos.:
`because they are dependent claims and are not drafted in accordance with the second and third sentences of Rule 6.4(a).
`
`Box No. Ill Observations where unity of invention is lacking (Continuation of item 3 of first sheet)
`
`This International Searching Authority found multiple inventions in this international application, as follows:
`
`1. I I As all required additional search fees were timely paid by the applicant, this international search report covers allsearchable
`I—I claims.
`
`2. As all searchable claims could be searched without effort justifying an additional fees, this Authority did not invite payment of
`additional fees.
`
`3. I "I As only some of the required additional search fees were timely paid by the applicant, this international search reportcovers
`I—' only those claims for which fees were paid.specifically claims Nos.:
`
`4. No required additional search fees were timely paid by the applicant. Consequently, this international search report is
`restricted to the invention first mentioned in the claims; it is covered by claims Nos.:
`
`Remark on Protest I I The additional search fees were accompanied by the applicant's protest and, where applicable, the
`
`I—I payment of a protest fee. ' payment of a protest
`• The additional search fees were accompanied by the applicant's protest but the applicable protest
`IThe additional searcf
`fee was not paid within the time limit specified in the invitation
`f
`
`I I No protest accompanied the payment of additional search fees
`
`Form PCT/ISA/210 (continuation of first sheet (2)) (April 2005)
`
`Page 17 of 18
`
`
`
`INTERNATIONAL SEARCH REPORT
`Information on patent family members
`
`International application No
`PCT/EP2008/057769
`
`Patent document
`cited in search report
`
`WO 2006061354
`
`US 2004158207 Al
`
`Publication
`date
`
`Patent family
`member(s)
`
`15-06-2006 CN 101072596 A
`EP 1824536.Al
`
`12-08-2004 WO 02081012 A2
`EP 1383560 A2
`JP 2004524926 T
`
`Publication
`date
`
`14-11-2007
`29-08-2007
`
`17-10-2002
`28-01-2004
`19-08-2004
`
`US 2007093754 Al
`
`26-04-2007 NONE
`
`Form PCT/ISA/210 (patent lamily annex) (April 2005)
`
`Page 18 of 18
`
`