PCT
`
`WORLD INTELLECTUAL PROPERTY ORGANIZATION
`International Bureau
`
`
`
`WO 98/24493
`
`11 June 1998 (11.06.98)
`
`(21) International Application Number:
`
`PCT/US97/22156
`
`(22) International Filing Date:
`
`5 December 1997 (05.12.97)
`
`(30) Priority Data:
`08/761,088
`60/047,110
`60/065,348
`
`5 December 1996 (05.12.96)
`19 May 1997 (19.05.97)
`12 November 1997 (12.1 1.97)
`
`US
`US
`US
`
`
`INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`
`(11) International Publication Number:
`(51) International Patent Classification 6 :
`A61M 5/00
`
`(43) International Publication Date:
`
`
`
`(81) Designated States: AL, AM, AT, AU, AZ, BA, BB, BG, BR,
`BY, CA, CH, CN, CU, CZ, DE, DK, EE, ES, FI, GB, GE,
`GH, HU, ID, IL, IS, JP, KE, KG, KP, KR, KZ, LC, LK,
`LR, LS, LT, LU, LV, MD, MG, MK, MN, MW, MX, NO,
`NZ, PL, PT, R0, RU, SD, SE, SG, SI, SK, 8]., TJ, TM, TR,
`"IT, UA, UG, US, UZ, VN, YU, ZW, ARIPO patent (GH,
`KE, LS, MW, SD, SZ, UG, ZW), Eurasian patent (AM, AZ,
`BY, KG, KZ, MD, RU, TJ, TM), European patent (AT, BE,
`CH, DE, DK, ES, FI, FR, GB, GR, IE, IT, LU, MC, NL,
`PT, SE), OAPI patent (BF, BJ, CF, CG, CI, CM, GA, GN,
`ML, MR, NE, SN, TD, TG).
`
`
`
`
`
`(71) Applicant (for all designated States except US): MDC IN-
`VESTMENT HOLDINGS, INC. [US/US]; Suite 200, 900
`Market Street, Wilmington, DE 19801 (US).
`
`(72) Inventors; and
`(75) Inventors/Applicants (for US only): BOTICH, Michael, J.
`[US/US]; 2330 Eagle Creek Lane, Oxnard, CA 93030 (US).
`HALSETH, Thor, R. [US/US]; 367 Buckboard Circle, Simi
`Valley, CA 93065 (US).
`
`(74) Agents: ELAND, Stephen, H. et 21].; Dann, Dorfman, Herrell
`and Skillman, P.C., Suite 720, 1601 Market Street, Philadel—
`phia, PA 19103—2307 (US).
`
`Published
`With international search report.
`Before the expiration of the time limit for amending the
`claims and to be republished in the event of the receipt of
`amendments.
`
`(54) Title: FLUID COLLECTION DEVICE WITH RETRACTABLE NEEDLE
`
`
`
`
`
`(57) Abstract
`
`This invention discloses a needle retraction mechanism for a needle bearing medical device wherein a needle retaining member (31)
`is bonded directly to the needle (15) for selective holding of the needle (15) in a projecting configuration from the device. The needle
`retaining member (31) has an axial extension configured to provide at least one finger, and preferably a plurality of separable fingers (47)
`that are jointed about a bore. Mutual engagement between the fingers and the needle can be enhanced by adhesive or thermal bonding.
`
`
`
`
`
`

`

`
`
`
`
`
`FOR THE PURPOSES OF INFORMATION ONLY
`
`BF
`
`AM
`AT
`AU
`AZ
`BA
`BB
`
` AL
`
`GB
`GE
`CH
`GN
`GR
`HU
`[E
`[L
`IS
`IT
`JP
`KE
`KG
`KP
`
`KR
`KZ
`LC
`Ll
`LK
`LR
`
`Codes used to identify States party to the PCT on the front pages of pamphlets publishing international applications under the PCT.
`SI
`Slovenia
`Lesotho
`LS
`Albania
`SK
`Slovakia
`LT
`Lithuania
`Armenia
`SN
`LU
`Austria
`Senegal
`Luxembourg
`SZ
`Swaziland
`LV
`Latvia
`Australia
`TD
`Chad
`Monaco
`MC
`Azerbaijan
`MD
`TG
`Togo
`Republic of Moldova
`Bosnia and Herzegovina
`MG
`'l‘J
`Barbados
`’l‘ajikistan
`Madagascar
`TM
`Turkmenistan
`MK
`The former Yugoslav
`Belgium
`TR
`Burkina Faso
`Turkey
`Republic of Macedonia
`TT
`Mali
`Trinidad and Tobago
`Bulgaria
`UA
`Ukraine
`Benin
`Mongolia
`UG
`Mauritania
`Brazil
`Uganda
`US
`United States of America
`Malawi
`Belarus
`UZ
`Uzbekistan
`Canada
`Mexico
`VN
`Viet Nam
`Niger
`Central African Republic
`Y U
`Netherlands
`Yugoslavia
`Congo
`Zimbabwe
`ZW
`Switzerland
`Norway
`New Zealand
`Cote d’Ivoire
`Poland
`Cameroon
`China
`Portugal
`Romania
`Cuba
`Russian Federation
`Czech Republic
`Sudan
`Gemrany
`Sweden
`Denmark
`Estonia
`Singapore
`
`Spain
`Finland
`France
`Gabon
`United Kingdom
`Georgia
`Ghana
`Guinea
`Greece
`Hungary
`Ireland
`Israel
`Iceland
`Italy
`Japan
`Kenya
`Kyrgyzstan
`Democratic People’s
`Republic of Korea
`Republic of Korea
`Kazakstan
`Saint Lucia
`Liechtenstein
`Sri Lanka
`Liberia
`
`ML
`MN
`MR
`MW
`MX
`NE
`NL
`NO
`NZ
`PL
`PT
`R0
`RU
`SD
`SE
`SG
`
`
`
`

`

`WO 98/24493
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`FLUID COLLECTION DEVICE WITH RETRACTABLE NEEDLE
`
`FIELD OF THE INVENTION
`
`The present invention relates to fluid collection
`
`devices for sampling fluid from a patient. More
`
`specifically,
`
`the invention relates to such a device
`
`having a retractable needle feature for rendering the
`
`device non—reusable and safely disposable.
`
`BACKGROUND OF THE INVENTION
`
`Various types of medical devices employ a needle
`
`for piercing the skin of a patient for diagnostic or
`
`therapeutic purposes. One such device is a blood
`
`collection device which includes a needle for piercing
`
`a blood vessel of the patient to allow blood to be
`
`sampled from the patient. When the needle is inserted
`
`into the blood vessel of the patient, blood is
`
`withdrawn through the needle into a vacuum collection
`
`tube. Handling of such needle—bearing medical devices
`
`after the needle is withdrawn from the patient can
`
`result in transmission of various pathogens, most
`
`notably human immune virus (HIV),
`
`to uninfected
`
`medical personnel, due to an inadvertent prick.
`
`Since the mid-1980s, concern over the risk of
`
`accidental needle stick injuries has spawned a number
`
`of design approaches for safety needle devices.
`
`Such
`
`devices can be broadly categorized as sliding sheath
`
`needle devices, wherein a physical barrier is
`
`positioned about the needle tip after use, and as
`
`needle—retraction devices, wherein the tip of the
`
`needle is retracted into the device after use.
`
`The
`
`category of needle retraction devices can be further
`
`subdivided into manual and automatic retraction
`
`devices. Manual retraction devices, as exemplified by
`
`U.S. Patent Nos. 4,026,287 to Haller, 4,592,744 to
`
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`Jagger, 4,808,169 to Haber et al. and 5,067,490 to
`
`Haber, require the user to pull or slide a needle—
`
`engaging mechanism rearwardly for a sufficient
`
`distance to retract the needle into the device.
`
`In
`
`automatic needle retraction devices, a biasing member,
`
`such as a spring,
`
`is employed to push or pull the
`
`needle into the device in response to activation of
`
`some release mechanism by the user.
`
`Such devices are
`
`exemplified by U.S. Patent Nos. 4,813,426 to Haber et
`
`al. and 5,125,414 to Dysarz.
`
`U.S. Patent No. 4,747,831 assigned to Becton
`
`Dickinson and U.S. Patent No. 4,900,307 to Kulli show
`
`respective automatic retractable-needle catheter
`
`stylets and syringes.
`
`The devices shown in the last—
`
`mentioned two patents are disclosed to be actuatable
`
`by the user who applies a simple unitary motion that
`
`entails a simple single—stage actuation movement
`
`in
`
`just one direction. Specifically,
`
`these latter
`
`patents show devices in which retraction is effected
`
`by depressing a single surface or member for a short
`
`distance in a single direction. Hence, during use of
`
`such devices,
`
`the user must be mindful not to
`
`prematurely trigger the needle retraction mechanism by
`
`accidentally contacting the surface for actuating the
`
`retraction mechanism.
`
`Since medical needle bearing
`
`devices are frequently employed under distracting
`
`circumstances, it would be desirable to provide an
`
`automatic needle retraction mechanism in which a
`
`compound action or dual motion is required by the user
`
`in order to effect automatic retraction of the needle.
`
`Such a mechanism would desirably require the user to
`
`act upon more than one surface of the retraction
`
`mechanism to effect withdrawal of the needle into the
`
`device.
`
`It further would be desirable to require that
`
`such actions to retract the needle occur along
`
`different directional axes to further decrease the
`
`likelihood of undesired premature or accidental
`
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`retraction of the needle.
`
`Of
`
`the aforementioned prior art devices which
`
`have automatic needle retraction mechanisms, all
`
`require a needle structure having an enlarged head,
`
`lip or rim extending radially outwardly from the axis
`
`of the needle to provide a block or enlarged surface
`
`on the needle which is biased toward retraction by the
`
`spring and which can be restrained against retraction
`
`by a latching arrangement or latch mechanism.
`
`In such
`
`devices, failure of the latch mechanism can occur to
`
`cause premature retraction of the needle. Hence, it
`
`would be desirable to provide an automatic needle
`
`retraction mechanism in which the latch mechanism
`
`operates more directly upon the needle.
`
`After use of a needle bearing medical device, a
`
`small volume of contaminated fluid or blood may remain
`
`inside the needle after it is withdrawn from the
`
`patient. Depending upon the gauge of the needle used
`
`with the device, such residual fluid or blood may be
`
`ejected from the forward end of the needle during the
`
`rearward acceleration experienced in retraction of the
`
`needle.
`
`Such forward fluid ejection can result from
`
`insufficient capillary adhesion to retain the residual
`
`fluid against inertial forces during needle
`
`retraction, or against the hydraulic force exerted
`
`upon the residual fluid by inrushing fluid or air
`
`during rearward acceleration in retracting the needle.
`
`It would also be desirable to provide a structure in
`
`an automatic needle retraction device that would
`
`prevent such ejection of residual blood or fluid from
`
`the forward end of the needle during retraction.
`
`SUMMARY OF THE INVENTION
`
`In accordance with one aspect of the present
`
`invention,
`
`there is provided a needle retraction
`
`mechanism for a needle bearing medical device wherein
`
`a needle retaining member is bonded directly to the
`
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`needle for selectively holding the needle in a
`
`projecting configuration from the device.
`
`The needle
`
`retaining member has an axial extension configured to
`
`provide at least one finger, and preferably a
`
`plurality of separable fingers that are joined about a
`
`central bore for holding the needle axially within the
`
`bore. Mutual engagement between the fingers and the
`
`needle can be enhanced by adhesive or thermal bonding.
`
`The needle retainer is positioned within the device to
`
`10
`
`restrain the needle against rearward bias exerted upon
`
`the needle by a spring.
`
`The spring is preferably also
`
`bonded directly to the needle, so that neither the
`
`bias force or the counteracting restraining force is
`
`15
`
`required to be mediated by any additional structure
`connected to the needle.
`
`In accordance with another aspect of the present
`
`invention,
`
`the needle bearing medical device is
`
`provided with an automatic retraction mechanism in
`
`which the user is required to execute a dual or
`
`compound motion in order to actuate the needle for
`
`withdrawing the needle into the device by movement of
`
`a biasing member.
`
`The preferred compound motion
`
`requires the user to effect two motions on separate
`
`surfaces of the device.
`
`Furthermore,
`
`these motions
`
`are preferably designed to be effected in distinct
`
`directions in order to assure intentional needle
`
`retraction.
`
`In accordance with another aspect of the present
`
`invention,
`
`there is provided a needle structure for
`
`use with an automatic retraction mechanism in a needle
`
`bearing device, wherein the needle structure includes
`
`means for preventing residual fluid from being ejected
`
`outwardly from the needle during rearward acceleration
`
`of needle retraction.
`
`The needle structure is
`
`configured to produce a partial vacuum within the rear
`
`of the needle during retraction by closure of a check
`
`valve mounted to the rear of the needle.
`
`In an
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`alternative embodiment,
`
`a hole is formed in the
`
`sidewall of the needle near a closed rear end of the
`
`needle, so that the partial vacuum is provided by a
`
`zone of reduced pressure generated in the vicinity of
`
`the hole by fluid flow around the end of the needle
`
`during retraction.
`
`In accordance with yet another aspect of the
`
`present
`
`invention, a dual—motion needle retraction
`
`mechanism is provided in combination with a fluid
`
`sampling device wherein the fluid sampling vial is
`
`removed from the device prior to activating the needle
`retraction mechanism.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`The foregoing summary, as well as the following
`
`detailed description of the preferred embodiments of
`
`the present invention, will be better understood when
`
`read in conjunction with the accompanying drawings,
`which:
`
`in
`
`FIG.
`
`1 is a sectional view of a retractable
`
`needle fluid collection device in accordance with the
`
`present invention;
`
`FIG. 2 is an enlarged sectional view of the
`
`retractable needle assembly portion of the retractable
`
`needle fluid collection device of FIG. 1, showing the
`
`retractable needle assembly portion in an as—shipped
`
`configuration with front and rear protective caps
`
`positioned thereon;
`
`FIG.
`
`3 is a sectional view of the retractable
`
`needle fluid collection device of FIG. 1, showing the
`
`needle in its retracted position;
`
`FIG. 4 is an exploded sectional view of the
`
`needle carrier assembly of the device of FIG. 1;
`
`FIG.
`
`5 is a sectional view of a check valve
`
`member incorporated in the device illustrated in Fig.
`1;
`
`FIG.
`
`5 is a sectional view of an alternate check
`
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`valve member operable in connection with the device
`
`illustrated in Fig. 1;
`
`FIG.
`
`7 is a side elevational view of a needle for
`
`use in retractable needle medical devices and
`
`illustrating lines of fluid flow about the needle
`
`during retraction;
`
`FIG.
`
`8 is an enlarged perspective view of a
`
`needle retainer structure incorporated in the
`
`retractable needle assembly shown in Fig. 2 for
`
`selectively holding the needle of a retractable needle
`
`medical device;
`
`FIG.
`
`9 is an enlarged sectional view of the
`
`needle retainer of the device shown in Fig. 2;
`
`FIG. 10 is an enlarged fragmentary sectional view
`
`of the device illustrated in Fig. 1, showing the
`
`needle in a retracted position;
`
`FIG. 11 is an enlarged sectional view of a
`
`sealing member incorporated in the device illustrated
`
`in Fig. 1;
`
`FIG. 12 is a side elevational view of an
`
`alternative arrangement for attaching a biasing spring
`
`to a needle;
`
`FIG. 13 is an enlarged fragmentary sectional View
`
`of the rear portion of the retractable needle assembly
`
`illustrated in Fig. 2;
`
`10
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`15
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`20
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`25
`
`FIG. 14 is a fragmentary sectional view of an
`
`alternative configuration for the rear portion of the
`
`needle carrier assembly illustrated in Fig. 13;
`
`FIG. 15 is a perspective view of a second
`
`30
`
`embodiment of a retractable needle fluid collection
`
`device in accordance with the present invention;
`
`FIG. 16 is a sectional view of the retractable
`
`needle fluid collection device of FIG. 15, shown with
`
`a vacuum collection tube positioned within the rear of
`
`35
`
`the device;
`
`FIG. 17 is a sectional view of the retractable
`
`needle fluid collection device of FIG. 15, showing the
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`WO 98/24493
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`front needle in its retracted position;
`
`FIG. 18 is a sectional view of the retractable
`
`needle fluid collection device of FIG. 15, showing
`
`attachment of a replacement needle barrel and needle
`
`assembly; and
`
`FIG. 19 is an enlarged,
`
`fragmentary view of a
`
`second embodiment of an abutment surface and abutment
`
`rib for preventing premature retraction of the front
`
`needle and a retention rib and stop surface for
`
`10
`
`preventing inadvertent separation of a sleeve from an
`
`adapter barrel.
`
`FIG. 20 is a side View of a third embodiment of a
`
`fluid collection device having a retractable insertion
`
`needle, with the insertion needle projecting forwardly
`
`15
`
`prior to use;
`
`FIG. 21 is a side elevational view of the fluid
`
`collection device illustrated in FIG. 20, showing the
`
`insertion needle retracted after use;
`
`FIG. 22 is an enlarged fragmentary view of the
`
`fluid collection device illustrated in FIG. 20;
`
`FIG. 23 is a cross~sectional View of the fluid
`
`collection device illustrated in FIG. 22,
`
`taken along
`
`line 23—23;
`
`FIG. 24 is a sectional view of a plug support
`
`member for providing an anti—fluid ejection mechanism
`
`for the device illustrated in FIG. 20;
`
`FIG. 25 is a rear elevational view of the plug
`
`support member of FIG. 24 from the perspective 25-25
`
`in Fig. 24.
`
`DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
`
`Referring to FIG. 1,
`
`there is shown a fluid
`
`collection device in accordance with the present
`
`invention.
`
`The device comprises a needle carrier
`
`structure generally designated 2 for retaining a
`
`forwardly projecting needle 15 and a rearwardly
`
`projecting needle 68.
`
`A re—usable holder adapter
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`generally designated 82 is mounted to the rear of the
`
`needle carrier structure for receiving a vacuum
`
`collection tube generally designated 105. After use
`
`of the device,
`
`the holder adapter 82 may be removed,
`
`and the needle carrier structure discarded.
`
`The needle carrier structure 2 is shown in an as—
`
`shipped condition or configuration in FIG. 2.
`
`The
`
`needle carrier 2 comprises a barrel 3 having a
`
`partially closed forward end 4 and an open rear end 5.
`
`A needle 15 is positioned for use at the forward end 4
`
`of the barrel 3 of the needle carrier 2.
`
`The needle
`
`15 comprises a sharp forward end or tip 17 suitable
`
`for use in fluid sampling, such as for blood sampling
`
`by accessing a patient’s vein.
`
`The needle 15 is
`
`preferably made of a biologically compatible material
`
`which can be easily sterilized, such as stainless
`
`steel.
`
`The forward portion of the needle 15 extends
`
`through an opening or axial hole 12 in the forward end
`
`4 of the barrel 3 of the needle carrier 2.
`
`The rear
`
`portion of the needle 15 extends generally axially
`
`into the barrel 3 of the needle carrier 2.
`
`A second
`
`or rear needle 68 projects rearwardly from the needle
`
`carrier 2 into the areas of the holder adapter 82
`
`which receives the vacuum collection tube 105.
`
`During shipment, storage, or other handling of
`
`the needle carrier structure 2 prior to use,
`
`the tip
`
`17 of the needle 15 is preferably surrounded and
`
`shielded by a front cap or sheath 79 that is removably
`
`attached to the exterior of the needle carrier 2.
`
`Likewise,
`
`the rear portion 73 of the rear needle 68 is
`
`preferably surrounded and shielded by a rear cap or
`
`sheath 80 during shipment, storage or other handling
`
`of the needle carrier structure 2 prior to use.
`
`The front and rear caps 79 and 80, respectively,
`
`are held upon the needle carrier 2 by, for example,
`
`cooperative frictional engagement between the surface
`
`protrusion of the exterior of the needle carrier 2 and
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`annular mating recesses of the front and rear caps 79
`
`and 80, as shown in FIG. 2.
`
`A spring 31 surrounds a portion of the needle 15
`
`within the forward end of the barrel 3.
`
`The spring is
`
`compressed therein and connected to the needle 15 for
`
`biasing the needle 15 toward the rear end 5 of the
`
`barrel 3.
`
`The spring 31 is preferably bonded to the
`
`needle 15 by an adhesive 33, such as an epoxy,
`
`preferably an ultraviolet
`
`(UV) curable adhesive, such
`
`as "LOCTITE 3001", which is distributed by Loctite
`
`Corp.
`
`The spring 31 may be bonded to the needle 15 at
`
`a location spaced from the rear end of the spring 31,
`
`so that one or more coils of the spring 31 can be
`
`grasped during the bonding process to insure that the
`
`spring 31 and needle 15 are properly oriented and
`
`bonded together.
`
`Alternatively, as shown in FIG. 12, wherein parts
`
`similar to those in FIG.
`
`2 are shown by the same
`
`number designator with the addition of 300 thereto,
`
`the spring 331 may be attached to the needle 315 by
`
`crimping the spring 331 to the needle 315 to form a
`
`reduced diameter portion 334 for the spring 331.
`
`The
`
`spring 331 then exerts a rearward bias upon the needle
`
`315 by virtue of a frictional engagement therebetween.
`
`In this arrangement,
`
`the reduced diameter portion 334
`
`of the spring 331 may also be bonded to the needle 315
`
`by adhesive to ensure permanent coupling of the Spring
`to the needle.
`
`Referring again to FIG. 1, a sealing member 35,
`
`such as a resilient cup, washer, silicone plug
`
`puncturable disc or the like,
`
`is positioned within the
`
`forward end 4 of the barrel 3 of the needle carrier 2.
`
`As best seen in FIG. 11,
`
`the preferred sealing member
`
`35 comprises a resilient cup 36.
`
`A puncturable
`
`membrane 37 forms the forward end 38 of the sealing
`
`member 35.
`
`The membrane 37 is sufficiently thin to be
`
`pierced by the tip 17 of the needle 15 to allow the
`
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`WO 98/24493
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`PCT/US97/22156
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`.. 10 _
`
`needle 15 to extend outwardly from the forward end 4
`
`of the barrel 3 of the needle carrier 2.
`
`In this
`
`extended configuration for the needle from the needle
`
`carrier,
`
`the membrane 37 provides a fluid—tight seal
`
`about the interior of the axial hole 12 in the forward
`
`end 4 of the barrel 3.
`
`The membrane 37 is
`
`sufficiently resilient to seal the axial hole 12 after
`
`the needle 15 has been retracted,
`
`to prevent fluid
`
`from leaking out of the barrel 3 when the needle is
`
`retracted.
`
`The sealing member 35 also promotes axial
`
`alignment of the needle 15 and the spring 31 within
`
`the barrel 3, by holding the forward end 40 of the
`
`spring 31 within a tubular portion 39 of the resilient
`
`cup 36. Additionally,
`
`the sealing member 35 helps to
`
`protect the tip 17 of the needle 15 from being damaged
`
`by contact with the interior of the barrel 3 when the
`
`needle 15 is inserted into the barrel 3 during
`
`assembly.
`
`Referring again to FIG. 2, a needle retainer 41
`
`is positioned within a forward portion of the barrel 3
`
`for selectively retaining the needle 15 in a
`
`configuration projecting outwardly from the needle
`
`carrier.
`
`A flange 42 is formed on the needle retainer
`
`41 for engagement with a complementary groove 7 formed
`
`about the interior of the barrel 3 for orienting and
`
`fixing the needle retainer in position. An annular
`
`detent 8 is formed on the inner surface of the barrel
`
`3 of the needle carrier 2 to prevent the needle
`
`retainer 41 from being dislodged from its position in
`
`the needle carrier 2. Holding of the needle retainer
`
`41 in position in the interior of the barrel 3 may be
`
`further assured by epoxy or ultrasonic welding.
`
`The forward end 43 of the needle retainer 41 is
`
`generally cylindrical. An axial bore 44 is formed in
`
`the needle retainer 41 for housing a portion of the
`
`needle 15 and the spring 31.
`
`The rear portion of the
`
`needle retainer 41 is provided with a latching
`
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`WO 98/24493
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`PCT/US97/22156
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`_ ll ._
`
`structure or mechanism for selectively retaining the
`
`needle 15 in its projecting position from the needle
`carrier 2.
`
`The engagement between the needle 15 and the
`
`needle retainer 41 is best seen in the enlarged view
`
`in FIG. 9.
`
`The latching structure or mechanism is
`
`preferably divided into a plurality of latching
`
`projections or fingers 47, which are formed at the
`
`rear end of the needle retainer 41, as Shown in FIG.
`
`8. When the needle retainer is positioned in the
`
`needle carrier,
`
`the fingers 47 extend axially rearward
`
`into the interior of the barrel 3 of the needle
`
`carrier 2.
`
`The fingers 47 are formed to have radially
`
`inwardly directed protrusions having interior surfaces
`
`48 in FIG. 9,
`
`forming a constricted portion 13 in bore
`
`44 of the needle retainer.
`
`The surfaces 48 are
`
`substantially parallel to the axial surface of the
`
`needle 15.
`
`The surfaces 48 are configured to conform
`
`to the outer surface of the needle 15 to thereby
`
`maintain the needle 15 in axial alignment within the
`
`needle retainer 41.
`
`The surfaces 48 of the fingers 47
`
`preferably form a continuous surface within the
`
`interior of the needle retainer 41 to enhance
`
`engagement with the needle 15.
`
`The continuous axial
`
`surface between the fingers 47 also provides a seal
`
`with the needle 15,
`
`so that fluid is kept out of the
`
`axial bore 44 in the needle retainer 41 during use in
`
`collecting fluid.
`
`The surfaces 48 of the fingers 47 are secured or
`
`bonded to the outer surface of the needle 15 using an
`
`adhesive 52, such as one of the adhesives or epoxies
`
`listed in Table 1 below.
`
`The preferred adhesive 52
`
`for a particular application will depend on such
`
`variables as the strength of the spring 31,
`
`the
`
`surface area of the constricted portion 13 of the bore
`
`44, and the material of which the fingers 47 and the
`
`needle are manufactured.
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`WO 98/24493
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`PCT/US97/22156
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`Table 1
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Henkel/Shell
`
`
`
`
`
`Epoxy
`
`
`
`Henkel Versamid 125
`
`catalyst/Shell Epon 828
`resin
`
`
`
`
`
`Eccobond LA 2843—23
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`uv
`
`w w
`
`
`
`
`
`
`
`
`
`As can be seen most clearly in FIG. 8,
`
`the needle
`
`retainer preferable comprises four fingers 47, but one
`
`or more fingers 47 may be employed depending on such
`
`factors as the size of the device and the nature of
`
`the biasing member (i.e., spring 31), for effecting
`
`optimum operation in holding the needle and
`
`facilitating needle retraction.
`
`The exterior of needle retainer 41 is provided
`
`with longitudinal grooves or score lines 49 between
`
`the fingers 47 to facilitate separation of the fingers
`
`and breakage of the fingers 47 when the retraction of
`
`10
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`PCT/US97/22156
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`the needle is actuated.
`
`In the initial configuration of the needle
`
`carrier shown in FIG. 1,
`
`the needle retainer 41 is
`
`positioned in the forward portion of the barrel.
`
`The
`
`spring 31 surrounds the needle 15 and is compressed
`
`between the rear of the sealing member 35 at the
`
`forward end 4 of the barrel 3 and the location at
`
`which the spring 31 is bonded to the needle 15 by
`
`adhesive 33. Hence,
`
`the needle 15 is biased toward
`
`the rear end 5 of the barrel 3 of the needle carrier 2
`
`and is held by the needle retainer fingers 47 against
`
`the bias of the spring.
`
`Referring again to FIG. 9,
`
`the fingers 47 are
`
`preferably flexible to permit outward movement to
`
`break the bond between the needle 15 and the retainer
`
`surfaces 48 in order to release the fingers 47 from
`
`the needle 15. Additionally,
`
`the fingers could be
`
`fractured when moved outwardly to release the needle.
`
`The fingers 47 are formed to have canted or wedge—
`
`shaped rearwardly facing surfaces 50 to facilitate
`
`engagement and spreading of the fingers 47, as
`
`described more fully herein below. As shown in FIG.
`
`10, when the fingers 47 are deformed or flexed
`
`radially outwardly to release the fingers 47 from the
`
`needle 15,
`
`the expansive force of the spring 31
`
`thrusts the needle 15 toward the rear end 5 of the
`
`barrel 3 of the needle carrier 2. Thus,
`
`the sharp end
`
`of the needle 15 is drawn into the barrel 3 to prevent
`
`accidental touching of the needle after use.
`
`Referring again to FIG. 2, an actuating member
`
`generally designated 53 is slidably positioned in the
`
`rear end 5 of the barrel 3 of the needle carrier 2.
`
`The actuating member 53 is manufactured from a
`
`material which is chemically compatible with the fluid
`
`being collected.
`
`For example,
`
`the actuating member 53
`
`may be made from polystyrene, which is suitable for
`
`use with blood collection devices. Alternatively,
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`WO 98/24493
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`_14_
`
`chemical compatibility may be provided by a conformal
`
`coating or layer of a chemically inert material, such
`
`as polytetrafluoroethylene, upon the surfaces of the
`
`actuating member 53 that come into contact with the
`
`fluid being collected.
`
`The actuating member 53 is generally cylindrical
`
`and is adapted to be received within the rear end of
`
`the barrel 3.
`
`The actuating member 53 has a flange 54
`
`formed thereon for engagement with the interior of the
`
`barrel 3
`
`to position and guide the actuating member
`
`during movement.
`
`A detent 9 is formed on the inner
`
`surface of the barrel 3 so that the flange 54 can be
`
`forced by the detent 9 during assembly, and thereafter
`
`prevented from being withdrawn from the barrel 3.
`
`The actuating member 53 includes structural
`
`features for effecting release of the needle 15 from
`
`the needle retainer 41.
`
`The forward end of the
`
`actuating member 53 comprises a tapered head 66 formed
`
`thereon, which provides a frustroconical forward
`
`surface.
`
`The forward surface of the head 66 provides
`
`an annular shoulder that is complementarily contoured
`
`or tapered to mate with the outwardly flared rearward
`
`surfaces 50 of the fingers 47 of the needle retainer
`
`41.
`
`To release the bond between the surfaces 48 of
`
`the fingers 47 and the needle 15,
`
`the actuating member
`
`53 is urged forward within the barrel 3 to spread the
`
`fingers outward by cooperative engagement between the
`
`head 66 and the rear surfaces 50 of the fingers, as
`shown in FIG. 10.
`
`In the as-shipped configuration shown in FIG. 2,
`
`the actuating member 53 is initially located at its
`
`initial or rearward position in the barrel 3, such
`
`that the flange 54 abuts with the detent 9 at the rear
`
`of the barrel 3.
`
`The head 66 of the actuating member
`
`53,
`
`in addition to providing a release mechanism for
`
`the needle 15,
`
`is sized to provide a fluid seal
`
`between the interior of the barrel 3 and the periphery
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`WO 98/24493
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`_15_
`
`of the head 66. During shipment or storage of the
`
`needle carrier,
`
`the material of which the actuating
`
`member 53 and the head 66 are formed may creep or
`
`deform to compromise the integrity of the fluid seal
`
`provided by the head 66.
`
`In order to ensure a fluid
`
`tight seal prior to use of the device,
`
`the barrel 3
`
`includes a reduced—diameter portion 10 located along
`
`the interior surface of the barrel 3 in the forward
`
`direction relative to the first position of the head
`
`66.
`
`Immediately prior to use of the needle carrier,
`
`the actuating member 53 is advanced within the body to
`
`a second or intermediate, position as shown in FIG. 1.
`
`In the second position of the actuating member 53,
`
`the
`
`head 66 is positioned within the reduced diameter
`
`portion 10 of the barrel 3.
`
`The constrictive force
`
`exerted on the head 66 by the interior of the barrel 3
`
`insures the integrity of the fluid seal provided
`
`therebetween. Advancement of the actuating member 53
`
`to the second position is automatically effected when
`
`the holder adapter 82 is connected to the needle
`
`carrier, as described hereinbelow.
`
`Referring again to FIG. 2,
`
`the actuating member
`
`53 has a hollow interior defining a chamber 56 having
`
`an open forward end 58 and a partially—closed or
`
`reduced diameter open rear end 57.
`
`The chamber 56 is
`
`sized to allow the needle 15 along with the attached
`
`spring 31 to be received into the chamber 56.
`
`The
`
`rear end 57 of the chamber 56 has an axial bore 60
`
`formed therein which has a smaller diameter than the
`
`chamber 56. Accordingly, a rear wall 67 is formed
`
`where the axial bore 60 adjoins the chamber 56. When
`
`the actuating member 53 is actuated for retraction of
`
`the needle 15,
`
`the spring 31 propels the needle
`
`rearwardly 15.
`
`The needle 15 and spring 31 are
`
`thereby propelled toward the rear of the chamber 56,
`
`and the rear wall 67 acts as a stop for the spring 31
`
`and the needle 15.
`
`The rear end of the actuating
`
`10
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`25
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`WO 98/24493
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`PCT/US97/22156
`
`_15_
`
`member 53 is shown in greater detail in FIG. 13.
`
`The
`
`axial bore 60 holds the rear needle 68 in a fixed,
`
`rearwardly projecting position.
`
`A forward portion 71
`
`of the rear needle 68 is held in the reduced diameter,
`
`axial bore 60.
`
`The clearance provided between the
`
`rear needle 68 and the axial bore 60 is selected to
`
`substantially prevent fluid passage between the rear
`
`needle 68 and the actuating member 53.
`
`A rear portion
`
`73 of the rear needle 68 extends beyond the rear end
`
`of the actuating member 53.
`
`To ensure that the rear
`
`needle 68 does not become dislodged from the actuating
`
`member 53,
`
`the rear needle 68 may be secured in place
`
`by an adhesive 78.
`
`A rearwardly projecting, axial
`
`extension 81 is formed on the rear end 59 of the
`
`actuating member 53 to further support and align for
`
`the rear needle 68.
`
`The extension 81 comprises a
`
`tubular section which is concentric with the axial
`
`bore 60 and which has an inner diameter of
`
`substantially the same dimension as the axial bore 60.
`
`An elastomeric boot 74 is positioned over the
`
`rear portion of the rear needle 68. During insertion
`
`of the device into the patient’s vein,
`
`the boot 74
`
`prevents fluid from prematurely flowing out from the
`
`needle carrier 2, and provides a visual indicator,
`
`when it receives fluid,
`
`that the needle 15 is properly
`
`inserted within the vein of the patient. When the
`
`needle 15 is properly inserted into the patient, fluid
`
`flows through the needle 15 and fills a "flashback"
`
`chamber defined by the interior of the barrel 3 of the
`
`needle carrier 2,
`
`the chamber 56 of the actuating
`
`member 53,
`
`the rear needle 68, and the interior of the
`
`boot 74.
`
`To facilita