(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`
`(19) World Intellectual Property Organization
`International Bureau
`
`
`
`(43) International Publication Date
`13 February 2003 (13.02.2003)
`
`(10) International Publication Number
`
`PCT
`
`WO 03/011381 A1
`
`(51) International Patent Classification7: A6lM 5/50, 5/32
`
`(21) International Application Number:
`
`PCT/EP02/08534
`
`(22) International Filing Date:
`
`30 July 2002 (30.07.2002)
`
`(25) Filing Language:
`
`(26) Publication Language:
`
`English
`
`English
`
`(30) Priority Data:
`B02001AOOO497
`
`31 July 2001 (31.07.2001)
`
`IT
`
`(71) Applicant 0’0}: all designated States except US): DELTA
`MED S.R.L. [IT/IT]; Via Gerbolina 15, I—46019 Viadana
`(Mantova) (IT).
`
`(72) Inventors; and
`(75) Inventors/Applicants for US only): VILLA, Danilo
`[IT/IT]; Via Bedoli 9/A, 1—46019 Viadana (MN)
`(IT).
`MINARI, Emanuele [IT/IT]; Via O. Artoni 13, I—42041
`Brescello (RE) (IT).
`
`(74) Agent: DONNE, E.; Bureau M.F.J. Bockstael nV., Aren—
`bergstraat 13, B—2000 Antwerpen (BE).
`
`(81) Designated States (national): AE, AG, AL, AM, AT, AU,
`AZ, BA, BB, BG, BR, BY, BZ, CA, CH, CN, CO, CR, CU,
`CZ, DE, DK, DM, DZ, EC, EE, ES, FI, GB, GD, GE, GH,
`GM, HR, HU, ID, IL, IN, IS, JP, KE, KG, KP, KR, KZ, LC,
`LK, LR, LS, LT, LU, LV, MA, MD, MG, MK, MN, MW,
`MX, MZ, NO, NZ, OM, PH, PL, PT, RO, RU, SD, SE, SG,
`SI, SK, SL, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ,
`VN, YU, ZA, ZM, ZW.
`
`(84) Designated States (regional): ARIPO patent (GH, GM,
`KE, LS, MW, MZ, SD, SL, SZ, TZ, UG, ZM, ZW),
`Eurasian patent (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM),
`European patent (AT, BE, BG, CH, CY, CZ, DE, DK, EE,
`ES, FI, FR, GB, GR, IE, IT, LU, MC, NL, PT, SE, SK,
`TR), OAPI patent (BF, BJ, CF, CG, CI, CM, GA, GN, GQ,
`GW, ML, MR, NE, SN, TD, TG).
`
`Declarations under Rule 4.17:
`
`as to applicant’s entitlement to apply for and be granted
`a patent (Rule 4.] 7(ii)) for the following designations AE,
`AG, AL, AM A]: AU, AZ, BA, BB, BG, BR, BX BZ, CA,
`CH, CIV, CO, CR, CU, CZ, DE, DK, DM, DZ, EC, EE, ES,
`FI, GB, GD, GE, GH, GM, HR, HU, ID, IL, IN, IS, JP, KE,
`KG, KR KR, KZ, LC, LK, LR, LS, LI,’ LU, LV,’ MA, MD, MG,
`MK, AIN, MW, MX, MZ, NO, NZ, OM PH, PL, PI: RO, RU,
`SD, SE, SG, SI, SK, SL, TJ, TM, TN, TR, TI: TZ, UA, UG,
`
`[Continued on next page]
`
`(54) Title: PROTECTIVE DEVICE FOR A NEEDLE
`
`
`
`/011381A1
`W00
`
`(57) Abstract: Protective device for a needle, more particularly for a catheter introducing needle or so—called cannula needle (2),
`whereby this protective device (1) comprises protective means (14) which slidably cooperate with the needle (5), characterized in
`m that said protective means (14) comprise a combination of at least, on one hand, safety means (16) having at least one part which,
`upon retraction of the needle (5) through the protective means (14), is placed in front of the needle point (18) and prevents the re—use
`of the needle (5), and, on the other hand, blocking means (19) which cooperate with the safety means (16) and which, when the
`protective device (1) passes from a non—operative state (A) into an operative state (B), release said safety means (16) from a blocked
`position into an unblocked position.
`
`B. Braun 2015
`
`1
`
`B. Braun 2015
`
`

`

`W0 03/011381 A1
`
`|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
`
`UZ, VN, YU, ZA, ZM, ZW, ARIPOpatent (GH, GM, KE, LS, 7 before the expiration of the time limit for amending the
`MW, MZ, SD, SL, SZ, TZ, UG, ZM, ZW), Eurasian patent
`claims and to be republished in the event of receipt of
`(AM AZ, BX KG, KZ, MD, RU, TJ, TM), European patent
`amendments
`(AT BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB,
`GR, IE, IT LU, MC, NL, PT SE, SK, TR), OAPIpatent (BF,
`BJ, CE CG, CI, CM GA, GN, GQ, GW, ML, AIR, NE, SN,
`TD, TO)
`7 ofinventorship (Rule 4. l 7(iv)) for US only
`
`For two-letter codes and other abbreviations, refer to the ”Guid-
`ance Notes on Codes andAbbreviations ” appearing at the begin-
`ning ofeach regular issue ofthe PCT Gazette.
`
`Published:
`
`7 with international search report
`
`2
`
`

`

`W0 03/011381
`
`PCT/EP02/08534
`
`Protective device for a needle.
`
`This
`
`invention is situated within the technical
`
`field of
`
`medical and surgical products and relates to a protective
`
`device for a needle.
`
`In first instance,
`
`the invention is intended to be used in
`
`combination with a catheter
`
`introducing needle or cannula
`
`needle, however,
`
`in general it is not excluded to use it in
`
`combination with other types of surgical needles.
`
`More particularly,
`
`the invention relates to a protective
`
`device which is capable of avoiding accidental pricking or
`
`wounds being inflicted on health staff during the use of
`the needles concerned.
`
`In
`
`case of
`
`a
`
`cannula needle
`
`assembly the operator
`
`is
`
`inserting the cannula and the needle which is provided in
`
`this cannula,
`
`by perforating the skin near
`
`the patient's
`
`vein or artery and introducing the needle and cannula with
`
`their
`
`tip into said vein or artery. Once
`
`the needle is
`
`inserted,
`
`the cannula remains in position, partially within
`
`the
`
`vein, while
`
`the
`
`needle, which
`
`has
`
`fulfilled its
`
`function,
`
`is taken out by the operator.
`
`This
`
`is
`
`the phase during which the sharp point of
`
`the
`
`extracted needle is dangerously exposed, with a high risk
`
`of pricking or wounding the operator.
`
`The
`
`operation
`
`involving
`
`replacing
`
`the
`
`needle
`
`into a
`
`protective
`
`hood
`
`is
`
`equally dangerous
`
`for
`
`the operator
`
`replacing it,
`
`as numerous specialised studies have shown
`
`statistically.
`
`CONHRMAHONCOPY
`
`3
`
`

`

`W0 03/011381
`
`PCT/EP02/08534
`
`In order
`
`to avoid this problem and to guarantee the safety
`
`of health staff during their activity, various kinds of
`
`protection devices applicable to cannula needles have been
`
`developped.
`
`Safety
`
`cannula
`
`needle
`
`assemblies
`
`are
`
`known,
`
`having
`
`a
`
`protective device allowing that
`the needle can be retracted
`within a protective element, which mayv be part of
`the
`
`assembly
`
`itself, whereby
`
`the withdrawal
`
`is obtained by
`
`activating a lever which pushes the needle correspondingly
`
`into the protective element, or manually,
`
`by manipulating
`
`an external handle connected to the needle which can slide
`
`along
`
`the
`
`axis
`
`of
`
`the
`
`protective
`
`element,
`
`thereby
`
`permitting withdrawal of the needle itself.
`
`The main disadvantage of
`
`these devices, which are already
`
`known to the profession,
`
`is the considerable volume of the
`
`protective
`
`element which
`
`may make
`
`it
`
`laborious
`
`and
`
`difficult
`
`for
`
`the operator
`
`to use these cannula. needles,
`
`resulting in that
`
`this known system is less practical and
`
`versatile.
`
`Another disadvantage of these protective devices, which are
`
`already known to the profession,
`
`is not only that
`
`they are
`
`complicated or
`
`composed of
`
`a
`
`large number‘ of parts, but
`
`also that
`
`they entail
`
`risks of not working properly and
`
`that high production costs are involved in producing each
`
`of the composing parts and in assembling them.
`
`A
`
`further
`
`disadvantage
`
`is
`
`that
`
`extra
`
`operations
`
`are
`
`necessary compared to unprotected devices, entailing the
`
`risk of omissions or wrongly executed operations
`
`by the
`
`operator.
`
`4
`
`

`

`W0 03/011381
`
`PCT/EP02/08534
`
`The profession is also acquainted with protective devices
`
`for cannula needles
`
`involving the use of
`
`a pair of rings
`
`linked by a flexible wire. The first ring is fixed to the
`
`base of the needle, while the second is fixed to the end of
`
`the cannula and is
`
`intended to guide extraction of
`
`the
`
`needle and to contain its point. The mechanism makes
`
`the
`
`needle
`
`slide,
`
`during ‘its
`
`extraction,
`
`through the axial
`
`forum of
`
`the second ring until
`
`its further extraction is
`
`stopped by the fixed length of flexible wire. Hereby,
`
`the
`
`needle arrives with its needle point
`
`into one of the rings.
`
`The needle, fitted into the ring with its point protected,
`
`can be safely pulled out of
`
`the cannula with the entire
`
`device comprising the two rings and the wire.
`
`The main disadvantage of
`
`this device is the considerable
`
`encum brance entailed by the two protective rings and above
`
`all by the flexible wire, which can make it laborious and
`
`difficult
`
`to
`
`use
`
`the
`
`cannula,
`
`needle,
`
`reducing
`
`its
`
`functional scope.
`
`A further disadvantage of these rings and in general of all
`
`the devices known to the profession,
`
`is that
`
`the patient's
`
`body fluids, and sometimes drugs, which may be deposited on
`the needle as drops or as an adhesive covering, are still
`
`accessible and/or
`
`that
`
`there still is a considerable risk
`
`that
`
`these fluids or drugs
`
`leave the protective device.
`
`Shocks may cause them to squirt on the bare skin or
`
`into
`
`the eyes of
`
`the operators or of others standing in the
`
`thereof,
`proximity
`contamination.
`
`entailing the Arisk
`
`of
`
`infection or
`
`The main object
`
`of
`
`this
`
`invention
`
`is
`
`to provide
`
`a
`
`protective
`
`device
`
`for
`
`needles, more
`
`particularly
`
`for
`
`cannula needles, which allows
`
`to considerably reduce the
`
`5
`
`

`

`W0 03/011381
`
`PCT/EP02/08534
`
`risk of contact with patient's body fluids or with drugs on
`
`the needle, and which prevents that an accidental pricking
`
`and the causing of wounds may happen, all this by means of
`
`a. device which is compact,
`
`resulting in that
`
`it
`
`is also
`
`easy to use and in that it is very versatile.
`
`A further
`
`aim is to provide a protective device that
`
`is
`
`easy to construct and assemble and hence not expensive.
`
`Furthermore,
`
`this
`
`protective
`
`device
`
`ensures
`
`maximum
`
`protection for the operator during extraction of the needle
`
`from the cannula.
`
`To this end,
`
`the invention relates to a protective device
`
`for a needle, more particularly for a catheter introducing
`needle or so—called cannula needle, whereby this protective
`
`device comprises protective means which slidably cooperate
`
`with the needle, which device is characterized in that said
`
`protective means comprise a combination of at least, on one
`hand,
`safety means having at
`least one part which,
`upon
`
`retraction of
`
`the needle through the protective means,
`
`is
`
`placed in front of the needle point and prevents the re—use
`of the needle, and, on the other hand, blocking means which
`
`the
`and which, when
`safety means
`the
`cooperate with
`protective device passes from a non—operative state into an
`operative state,
`release said safety means
`from a blocked
`
`position into an unblocked position.
`
`The fact
`
`that, according to the invention, a combination is
`
`made
`
`of
`
`safety
`
`means with
`
`blocking means,
`
`which
`
`automatically release the safety means
`
`from a blocked into
`
`an unblocked position, offers the advantage that the device
`
`functions very efficiently,
`
`as will
`
`be clear
`
`from the
`
`following detailed description.
`
`6
`
`

`

`W0 03/011381
`
`PCT/EP02/08534
`
`According ix) a preferred embodiment,
`
`the safety means and
`
`the blocking means are configured in such a manner
`
`that,
`
`upon
`
`retraction of
`
`the needle,
`
`the
`
`safety means, more
`
`particularly the part or parts which are placed in front of
`the needle point,
`remain at
`a distance from the needle
`
`during the entire retraction thereof.
`
`In other words,
`
`during
`
`the
`
`complete
`
`retraction,
`
`there
`
`is
`
`no
`
`contact
`
`between,
`
`on
`
`the
`
`one
`
`hand,
`
`the
`
`safety means,
`
`more
`
`particularly said safety tongue or safety tongues, and, on
`the other hand,
`the needle. As a result thereof,
`the safety
`
`means, more particularly said tongues, will never urge
`
`fluids adhered to the needle towards
`
`the needle point and
`
`off
`
`the needle point.
`
`In this manner,
`
`it
`
`is avoided that
`
`fluids
`
`are
`
`scraped completely
`
`from the needle and
`
`can
`
`consequently leave the protective device.
`
`In the most preferred embodiment,
`
`said blocking means are
`
`shiftable in respect
`
`to the safety means,
`
`such that,
`
`by
`
`means of
`
`a shifting movement of
`
`the blocking' means,
`
`the
`
`safety means are released from a blocked position into an
`
`unblocked. position, whereby said. blocking means cooperate
`
`with the needle in such a nanner
`
`that
`
`a displacement and
`
`retraction of
`
`the needle also causes
`
`the above shifting
`
`movement of the blocking means.
`
`In this way, with a minimum
`
`of constructive parts,
`
`a device is offered which can. be
`
`actuated automatically,
`
`just
`
`by
`
`the
`
`retraction of
`
`the
`
`needle.
`
`In a practical embodiment,
`
`the blocking means substantially
`
`consist of a sliding ring located around the needle.
`
`Preferably,
`
`the abovesaid part or parts are elastically
`
`bendable
`
`and consist of
`
`safety tongues,
`
`such that
`
`these
`
`4 parts are automatically urged into the path of
`
`the needle
`
`7
`
`

`

`W0 03/011381
`
`PCT/EP02/08534
`
`upon retraction of
`
`the latter.
`
`In such case,
`
`the blocking
`
`means can be formed of an element,
`
`such as a ring, which in
`
`the non—operative state of
`
`the protective device,
`
`keeps
`
`said parts out of the path of the needle.
`
`Further,
`
`the device is preferably characterized in that the
`
`protective means
`and the needle comprise stopping Ineans,
`acting as abutment means between the protective means and
`
`the needle, which define an end position when retracting
`
`the
`
`needle,
`
`such
`
`that
`
`the
`
`needle
`
`cannot
`
`leave
`
`the
`
`protective means.
`
`According to a
`
`further
`
`important preferred feature,
`
`the
`
`protective device is provided with scraping means
`
`to dry
`
`the
`
`needle when
`
`the
`
`device
`
`itself
`
`passes
`
`from the
`
`non—operative state to the operative state. These scraping
`
`means, which preferably consist of an O—ring, considerably
`
`improve the safety of the device, as will become clear from
`
`the further description.
`
`Further,
`
`it
`
`is preferred that
`
`said protective means are
`
`provided with a rear wall having a rear side, whereby the
`
`scraping means
`
`in their outermost position remain located
`
`at
`
`a distance from the rear
`
`side of said rear‘ wall.
`
`In
`
`respect
`
`to this,
`
`it should be noted that fluids, which are
`
`scraped or wiped from the needle, are collected in front of
`
`the scraping means. At
`
`the end,
`
`it is never excluded that
`
`these fluids may penetrate in between the scraping means
`and the needle surface by means of a pumping effect which
`
`may be created when moving the needle sidewards in respect
`
`to the scraping means. Due
`
`to this pumping effect,
`
`some
`
`fluid may arrive at
`
`the rear side of the scraping means. By
`
`preserving a distance between this rear side and the rear
`
`side of
`
`the rear wall,
`
`it is impossible that
`
`the operator
`
`8
`
`

`

`W0 03/011381
`
`PCT/EP02/08534
`
`which handles
`
`the device can come
`
`into contact with the
`
`fluid in question.
`
`It
`
`is clear
`
`that
`
`the fact
`
`that
`
`the safety tongues do not
`
`come
`
`into
`
`contact with
`
`the
`
`needle
`
`during
`
`the
`
`entire
`
`retraction of
`
`the needle,
`
`is also advantageous
`
`in other
`
`protective devices
`
`for needles. Therefore, according to a
`
`second aspect,
`
`the invention also relates to a protective
`
`device
`
`for
`
`a needle, more particularly for
`
`a catheter
`
`introducing
`
`needle,
`
`whereby
`
`this
`
`protective
`
`device
`
`comprises protective means which slidably cooperate with
`
`the needle,
`
`characterized in that
`
`said protective means
`
`comprise one or more safety tongues which upon retraction
`
`of
`
`the needle are automatically positioned in front of the
`
`needle point,
`thereby preventing the needle
`from being
`re—used, whereby these tongues upon the complete retraction
`
`movement of the needle remain at a distance from the needle.
`
`Also
`
`the
`
`abovesaid
`
`feature
`
`that
`
`scraping means, more
`
`for all
`
`particularly a
`
`scraping
`
`ring
`
`is
`
`used which
`
`conditions remain at a distance from the rear side or the
`
`rear wall
`
`of
`
`the protective
`
`device
`
`can
`
`be
`
`used
`
`in
`
`combination with other
`
`types of protective devices, which
`
`must not necessarily be
`
`equipped with blocking means.
`
`Therefore, according to a third aspect,
`
`the invention also
`
`relates
`
`to
`
`a
`
`protective
`
`device
`
`for
`
`a
`
`needle, more
`
`particularly for
`
`a catheter
`
`introducing needle, whereby
`
`this protective device comprises
`
`a housing which slidably
`
`cooperates with the needle such that
`
`the needle can be
`
`retracted upto a position in which the needle point
`
`is
`
`located
`
`in
`
`said
`
`housing,
`
`characterized
`
`in
`
`that
`
`said
`
`protective
`
`device
`
`comprises
`
`a
`
`scraping
`
`ring
`
`which
`
`cooperates with the needle, whereby this scraping ring is
`
`9
`
`

`

`W0 03/011381
`
`PCT/EP02/08534
`
`located,
`
`inside the housing,
`
`at
`
`a distance from the rear
`
`side of the rear wall of said housing.
`
`It
`
`is clear that
`
`the invention also relates to needles and
`
`safety cannula needle assemblies which are provided with a
`
`protective device of the invention.
`
`Other
`
`features will
`
`become
`
`clear
`
`from the
`
`following
`
`detailed description and the appended claims.
`
`In order
`
`to better explain the features of
`
`the present
`
`invention,
`
`hereafter,
`
`several preferred embodiments
`
`are
`
`described
`
`as
`
`examples without
`
`being
`
`limitative, with
`
`reference to the accompanying drawings,
`
`in which:
`
`Figure 1
`
`represents a cross—section lateral View of a
`
`cannula needle
`
`assembly provided with a protective
`
`device
`
`according to the
`
`invention,
`
`said protective
`
`device being in non—operative state;
`
`figure
`
`2
`
`represents
`
`an
`
`enlargement of
`
`the portion
`
`which is indicated by F2 in figure 1;
`
`figure 3
`
`represents
`
`the portion shown
`
`in figure 2,
`
`during retraction of the needle;
`
`figure
`
`4
`
`represents
`
`a
`
`cross—section
`
`lateral
`
`view
`
`similar as
`
`:uu
`
`figure 1, however, with the needle in
`
`retracted position and with
`
`the protective device
`
`being operative;
`figure
`5
`represents
`
`an
`
`enlargement of
`
`the portion
`
`which is indicated by F5 in figure 4;
`
`figure
`
`6
`
`represents
`
`a
`
`cross—section
`
`lateral
`
`view
`
`similar
`
`as
`
`in
`
`figure
`
`4,
`
`however,
`
`after
`
`that
`
`the
`
`needle,
`
`together with
`
`the
`
`protective
`
`device,
`
`is
`
`separated from the cannula;
`
`10
`
`10
`
`

`

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`
`PCT/EP02/08534
`
`figures 7 and 8 represent an alternative embodiment of
`
`the
`
`invention,
`
`for
`
`the non—operative
`
`and operative
`
`state respectively of the protection device;
`
`figures
`
`9
`
`and
`
`10
`
`represent
`
`a
`
`further alternative
`
`embodiment of the invention,
`
`for the non—operative and
`
`operative state respectively of the protection device;
`
`figures
`
`11
`
`and
`
`12
`
`represent
`
`a
`
`still
`
`further
`
`alternative
`
`embodiment
`
`of
`
`the
`
`invention,
`
`for
`
`the
`
`non—operative state and the state during retraction of
`
`the needle, respectively;
`
`figure 13
`
`represents a perspective View of
`
`the part
`
`which in figure 11
`
`is indicated by F13.
`
`With reference to figures 1
`
`to 6,
`
`reference 1
`
`in general
`
`indicates a protective device for a cannula needle 2, which
`
`cannula needle 2,
`
`together with 'the cannula 3,
`
`forms
`
`a
`
`complete cannula needle assembly 4.
`
`With the cannula needle 2,
`
`the complete part is meant which
`
`is formed by the actual needle 5
`
`and a needle hub 6
`
`in
`
`which this needle 5
`
`is attached. The needle 5 fits to the
`
`cannula 3 and is preferably hollow. The inner channel
`
`7
`
`is
`
`in connection with an opening 8 in the needle hub 6, which,
`
`for
`
`example allows
`
`a connection with a
`
`so—called flash
`
`chamber, or with any other accessory. As represented,
`
`the
`
`needle hub 6 may be provided with a support 9.
`
`The cannula 3
`
`is carried out
`
`in a conventional manner and
`
`mainly consists ,of
`
`an elongated hollow front portion 10,
`
`which is intended to be partly introduced in a vein of the
`
`patient and which furthermore comprises a rear portion 11
`
`acting as a cannula hub which is provided with an entrance
`
`opening 12 for introducing the needle 5 into the cannula 3.
`
`The entrance opening 12 is also intended to be coupled to a
`
`11
`
`11
`
`

`

`W0 03/011381
`
`PCT/EP02/08534
`
`tube for fluid supply or
`
`the like after retraction of
`
`the
`
`needle 5. As shown,
`
`the cannula 3 may be provided with one
`
`or more additional entrance openings
`
`13; Of course,
`
`the
`
`cannula 3 may also be used for introducing other medical or
`
`surgical
`
`substances
`
`or
`
`elements,
`
`for
`
`example,
`
`for
`
`introducing a catheter by means of
`
`a vein, artery or
`
`the
`
`like into a patient's body.
`
`The protective device 1
`
`substantially consists of,
`
`on the
`
`one
`
`hand,
`
`protective means,
`
`generally
`
`indicated
`
`by
`
`reference 14, which slidably fit onto the needle 5, and, on
`
`the other hand, stopping means 15, acting as abutment means
`
`between the protective means
`
`14
`
`and the needle 5, which
`
`abutment means define an end position when retracting the
`
`needle 5
`
`through the protective means 14.
`
`Said protective means 14 comprise, on the one hand, safety
`
`means 16 having at
`
`least one part,
`
`in this case,
`
`a safety
`
`tongue
`
`17, which,
`
`upon retraction of
`
`the needle
`
`5,
`
`is
`
`placed in front of the point 18 of the needle 5,
`
`such as to
`
`prevent
`
`the re—use of
`
`this needle and, on the other hand,
`
`blocking means
`
`19 which cooperate with the safety means 16
`
`and which,
`
`when
`
`the protective
`
`device passes
`
`from a
`
`non—operative state A
`
`into an operative state B,
`
`release
`
`said safety means
`
`16
`
`from a blocked position into an
`
`unblocked position, as described in detail in the following.
`
`As
`
`shown,
`
`the safety means 16 and the blocking means 19 are
`
`preferably incorporated in a hollow body or housing 20
`
`having a
`
`side wall
`
`21
`
`and two opposed end walls
`
`22—23,
`
`which are each provided with a passage opening 24—25
`
`for
`
`the needle 5.
`
`12
`
`12
`
`

`

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`
`PCT/EP02/08534
`
`The safety tongue 17 consists of
`
`an elastically bendable
`
`lip, which in this case forms one part with the end wall
`
`22,
`
`and which is configured and arranged in such a manner
`
`that,
`
`in its free position,
`
`it extends through the path of
`
`the needle 5, preferably in an oblique manner, as shown in
`
`figures 4 to 6.
`
`The
`
`blocking means
`
`19
`
`comprise
`
`an
`
`element which
`
`shiftably fitted in the hollow body 20, which element,
`
`is
`
`in
`
`the represented example, consists of a ring 26 composed of
`
`an inner cylindrical ring part 27 and an outer cylindrical
`
`ring part
`
`28
`
`fixedly connected to each other. The outer
`
`cylindrical
`20.
`
`ring part precisely fits into the hollow body
`
`The ring 26 is configured such that,
`
`in the non—operative
`
`state A of
`
`the protection device 1,
`
`in which the needle 5
`
`is completely inserted into the cannula 3,
`
`the ring 26
`
`cooperates with the safety tongue 17
`
`such that
`
`the latter
`
`is bent outwardly,
`
`in an open. position. S,
`
`in which this
`
`tongue 17 is not
`
`interfering with the needle 5. Hereby, as
`
`shown in figures 1
`
`and 2,
`
`the tongue 17 and the ring 26,
`
`more particularly the outer
`
`ring part
`
`28,
`
`are slightly
`
`hooking behind each other, by means of a recess 29
`
`in the
`
`free end of
`
`the tongue 17
`
`and a collar.
`
`30 at
`
`the front
`
`outer end of said ring part 28.
`
`The above mentioned stopping means
`
`15 consist of abutment
`
`parts which
`
`are provided at
`
`the needle
`
`5
`
`and at
`
`the
`
`protective means
`
`14,
`
`respectively.
`
`In the embodiment of
`
`figures
`
`1
`
`to 6,
`
`these abutment parts are formed by
`
`an
`
`annular groove
`
`31 nearby the point of
`
`the needle 5
`
`and
`
`retaining* means consisting of strips or
`
`fins 32 directed
`
`towards
`
`the axis of
`
`the
`
`ring 26
`
`and
`
`inclined in the
`
`13
`
`13
`
`

`

`W0 03/011381
`
`PCT/EP02/08534
`
`-12-
`
`direction opposite
`
`to the
`
`extraction direction of
`
`the
`
`needle 5.
`
`Furthermore,
`
`the protective
`
`device
`
`1
`
`is
`
`provided with
`
`scraping means
`
`33 to dry the needle 5 sliding through it,
`
`thereby freeing it from blood or other body fluids from the
`
`of
`consist
`33
`scraping means
`These
`patient.
`membrane or disk having a central opening, or
`
`ring,
`a
`the like,
`
`fitting with a certain tension around the needle 5, which
`
`ring, membrane or disk preferably is made of
`
`a
`
`flexible
`
`synthetic material. More particularly,
`
`these means
`
`are
`
`formed by an O—ring.
`
`The protective means 14, more particularly the housing 20,
`is carried out as an extension piece, which can be coupled
`to the catheter hub. To this end,
`the housing is provided
`
`with coupling means
`
`34 at
`
`the end wall
`
`22,
`
`allowing a
`
`releasable connection with said catheter hub, preferably by
`
`means of a snap connection. To this end,
`
`in the represented
`
`embodiment,
`
`said coupling means
`
`34 comprise a number of
`
`elastically bendable fins 35, having locking portions 36
`
`which can cooperate with a collar 37 at
`
`the rear edge of
`
`the rear portion of the cannula 3.
`
`As
`
`shown,
`
`the needle hub preferably comprises at least one
`
`part
`5,
`
`the needle
`forward position of
`in the most
`38 which,
`cooperates with
`the protective means
`14,
`thereby
`
`a
`from carrying out
`14
`preventing .the blocking means
`shifting movement
`from the non—operative position A to the
`
`operative position B. This is obtained in that this part 38
`extends
`through the opening 25
`into the hollow: body 20,
`
`thereby forming an obstacle for
`
`the displacement of
`
`the
`
`blocking means 14. More particularly, as shown in figure 2,.
`
`said shifting is prevented in that
`
`the free end of part 38
`
`14
`
`14
`
`

`

`W0 03/011381
`
`PCT/EP02/08534
`
`_ 13 _
`
`comes
`
`into contact with said inner ring part 27 and/or said
`
`fins 35.
`
`The functioning of
`
`the protective device 1
`
`is substantially
`
`as described in the following.
`
`Once
`
`the needle 5
`
`and the cannula 13 are inserted into a
`
`is retracted from
`the needle 5
`patient's vein or artery,
`the cannula 3,
`resulting in that
`the protective means
`14
`
`are
`
`automatically
`
`activated
`
`and
`
`are
`
`put
`
`from
`
`a
`
`non—operative state A into an operative state B.
`
`In the beginning,
`
`in the non—operative state A,
`
`the part 38
`
`is in contact with the inner
`
`ring part 27,
`
`resulting in
`
`that
`
`the
`
`blocking means
`
`14
`
`are
`
`prevented
`
`from being
`
`displaced,
`
`resulting in that
`
`the safety tongue 17
`
`is kept
`
`in the position, as shown in figures 1 and 2.
`
`When
`
`retracting the needle 5,
`
`first,
`
`this needle freely
`
`slides through the protective means 14. From the moment on
`
`that
`
`the annular groove 31 arrives at
`
`the height of
`
`the
`
`fins 32,
`
`these fins are elastically urged into the annular
`
`the needle 5 cannot make any
`resulting in that
`groove 31,
`further
`sliding movement
`through
`the
`ring
`26.
`As
`a
`
`consequence,
`
`the ring 26 is taken along with the movement
`
`of
`
`the needle 5, causing that
`
`the ring 26,
`
`in other words
`
`the blocking means
`
`19,
`
`are freeing the tongue 17, which
`
`interposes
`itself between the passage opening 24
`and the
`point
`18 of
`the needle
`5,
`corresponding to a state of
`release R.
`
`Upon further retraction,
`
`the ring 26 will contact
`
`the end
`
`wall
`
`23,
`
`as
`
`shown
`
`in figure 5,
`
`and,
`
`as
`
`a
`
`consequence
`
`thereof,
`
`any further extraction movement of
`
`the needle 5
`
`15
`
`15
`
`

`

`W0 03/011381
`
`PCT/EP02/08534
`
`_ 14 _
`
`from the protective means 14 is prevented. Hereafter,
`
`the
`
`cannula needle 2 can be disconnected from the cannula 3 by
`
`means of the releasable coupling means 34.
`
`In this way,
`
`in the operative state B,
`
`the point 18 of the
`
`needle 5 cannot come out of the protective means 14 because
`
`it
`
`is blocked,
`
`in the direction of
`
`the opening 25 by the
`
`activation of
`
`the stopping means 15,
`
`and in the opposite
`
`direction by the tongue 17 which is interposed between the
`
`needle point 18 and the opening 24.
`
`The protective means 14 are preferably configured in such a
`
`manner
`
`that any contact between the safety tongue 17 and
`
`the needle 5
`
`is excluded for the complete retraction of the
`
`needle
`
`5.
`
`In this way,
`
`it
`
`is
`
`excluded that
`
`the safety
`
`tongue 17 acts as a scraping element
`
`for the needle 5 and
`
`that,
`
`on the moment
`
`that
`
`the tongue 17
`
`is released, blood
`
`or other
`
`fluids are projected through the passage opening
`
`In normal
`24 and possibly are contaminating this opening.
`use,
`in the design of
`figures
`1
`to 6
`there will be no
`
`contact between the tongue 17 and the needle point
`
`18 on
`
`the moment
`
`that
`
`the tongue
`
`17 bends back into its free
`
`position. However,
`
`in order
`
`to exclude any contact,
`
`the
`
`point
`
`18 can be further shortened, as
`
`indicated in dashed
`
`line 39 in figure 3.
`
`The geometrical
`
`form and the inclination of
`
`the fins 32
`
`make
`
`it possible to transfer
`
`the needle
`
`5
`
`towards
`
`the
`
`cannula
`
`3 during the phase of
`
`assembly of
`
`the cannula
`
`needle
`
`assembly
`
`4. Also
`
`the
`
`blocking means
`
`19
`
`are
`
`advantageous during the assembly,
`
`as
`
`by means
`
`of.
`
`these
`
`blocking means
`
`19,
`
`the
`
`tongue
`
`17
`
`can
`
`be kept
`
`in
`
`an
`
`non—activated
`
`state,
`
`allowing
`
`the
`
`free passage
`
`of
`
`the
`
`needle 5
`
`to the protective means 14.
`
`16
`
`16
`
`

`

`W0 03/011381
`
`PCT/EP02/08534
`
`_ 15 _
`
`to the
`During the passage from the non—operative state IX
`operative state B,
`the needle 5 slides through the scraping
`means 33 which dry it from the liquids that are adhered to
`this needle
`5,
`thereby retaining these
`liquids
`in the
`hollow body 20. Hence, although the shaft of the needle 5
`
`is no longer sterile,
`
`a decisive reduction of any infective
`
`takes place,
`5
`the needle
`adhered at
`toxic products
`or
`anyone who might have
`to
`thereby reducing the risk for
`touch
`the
`shaft
`of
`the
`needle
`5 with
`bare
`hands.
`
`Furthermore, although the hollow body 20 is not completely
`
`the fluids retained in it by the scraping means 33
`closed,
`are practically completely held inside, even if the needle
`
`5 were to undergo shocks or vibrations.
`
`In the embodiment of figures 1
`
`to 6,
`
`the coupling means 34
`
`and the end wall 22 are made in one piece and together form
`
`a separate part which acts as a cover which is connected to
`
`the side wall 21
`
`in any manner.
`
`According to a variant,
`
`the coupling means 34 may also be
`
`moulded in a single piece with the hollow body 20.
`
`show a second embodiment of the protective
`Figures 7 and 8
`device 1
`in which the safety means 16 consist of a pair of
`
`facing
`40—41,
`opposed elastically bendable safety tongues
`each other and fixed to the end wall 23. The tongues 40—41
`
`have
`
`a different
`
`length and consist of
`
`an elastically
`
`bendable first portion 42 which substantially extends
`
`in
`
`this first
`the distal end of
`lengthwise direction and, at
`directed
`portion
`42,
`a
`second
`portion
`43 which
`is
`transversely or substantially transversely in respect
`to
`
`the
`
`first
`
`portion
`
`42.
`
`The
`
`safetyv tongues
`
`40—41
`
`are
`
`they are
`configured such that by means of their elasticity,
`permanently urged towards
`a position 111 which the second
`
`17
`
`17
`
`

`

`W0 03/011381
`
`PCT/EP02/08534
`
`_ 15 _
`
`portions 43 are located in the path followed by the needle
`5.
`
`The
`
`end wall
`
`23
`
`is carried out
`
`in the form of
`
`a
`
`flange.
`
`This
`
`flange,
`
`together with
`
`the
`
`tongues
`
`40—41
`
`form an
`
`insertion piece, which, by means of a snap coupling 44,
`
`is
`
`mounted into the hollow body 20.
`
`In this embodiment,
`
`the blocking means 19 consist of a ring
`
`45 which is located around the needle 5 and in between the
`
`tongues
`
`40—41,
`
`such that
`
`these tongues
`
`40—41
`
`by means of
`
`said ring 45 can be kept
`
`in an open state S, as shown in
`
`figure 7.
`
`Similarly as
`
`1J1
`
`figures 1
`
`to 6,
`
`the :ring'
`
`45
`
`.is provided
`
`with fins 32.
`
`It
`
`should be noted that
`
`in figure 7
`
`the configuration is
`
`chosen such that
`
`the tongues 40—41 are in contact with the
`
`ring 45,
`
`as well as in contact with the needle 5. Hereby,
`
`'the tongues
`
`40—41
`
`are only in slight contact with the
`
`needle 5,
`
`resulting in that, during the retraction of
`
`the
`
`needle
`
`5,
`
`no
`
`important
`
`frictional
`
`forces
`
`have
`
`to be
`
`surmounted.
`
`It
`
`is clear that, according to alternative embodiments and
`
`dependent on the diameter of the ring 45 and/or the lengths
`
`of
`
`the second portions
`
`43,
`
`there may or may not be
`
`a
`
`contact between the free ends of the tongues 40—41 and the
`
`needle 5.
`
`In fact,
`
`the first aim of the blocking means 19 is to keep
`
`the tongues 40—41 separated from each other when no needle
`
`5
`
`is
`
`inserted in between,
`
`thereby allowing that,
`
`upon
`
`18
`
`18
`
`

`

`W0 03/011381
`
`PCT/EP02/08534
`
`insertion of
`
`the needle 5
`
`to the protective means 14,
`
`this
`
`needle 5 can be shifted through the hollow body 20.
`
`During the passage from the non—operative state IX
`
`to the
`
`operative state B,
`31
`of
`the needle
`
`the fins 32 engage in the annular groove
`5 during the latter's axial
`sliding,
`
`thereby causing the ring 45 to slide towards the end wall
`
`23. This
`
`sliding motion
`
`of
`
`the
`
`ring 45
`
`permits
`
`the
`
`disengaging of the free ends of the tongues 40—41,
`
`so as to
`
`reach the state of release R,
`
`in which these free ends are
`
`curved towards each other,
`
`thus placing the tongues 40~41
`
`between the passage opening 24 and the needle point 18. The
`
`different
`
`lengths of
`
`the tongues 40—41 allow the respective
`
`free ends to overlap each other, preferably without causing
`
`any interference,
`
`thereby avoiding the possibility of
`
`the
`
`needle 5 coming out of the hollow body 20.
`
`the invention,
`Figures 9 and 10 show a further variant of
`the only difference with the embodiment of
`figures
`7—8
`
`the ring, 45 has no fins 32 and. directly' fits
`being that
`around the needle 5, whereas
`the stopping means
`15 at
`the
`
`needle 5 consist. of
`
`a
`
`ridge 46 or
`
`thickening nearby the
`
`needle point 18.
`
`In this way,
`
`the side 47 of
`
`the ring 45
`
`forms an abutment for the ridge 46.
`
`An advantage of
`
`this embodiment consists in the fact that
`
`the scraping means
`
`33 and the abutment means cooperating
`
`with the ridge 46 are formed by one
`
`and the same part,
`
`namely said ring 45. Furthermore,
`
`this ring 45 also acts as
`