(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2014/0188053 A1
`LUNDQUIST
`(43) Pub. Date:
`Jul. 3, 2014
`
`US 2014O188053A1
`
`(54) SYRINGE WITH CO-MOLDED HUB AND
`CANNULA
`
`(71) Applicant: WEST PHARMACEUTICAL
`SERVICES, INC., Exton, PA (US)
`
`(72) Inventor: Jon Tyler LUNDQUIST, Pagosa
`Springs, CO (US)
`
`(73) Assignee: WEST PHARMACEUTICAL
`SERVICES, INC., Exton, PA (US)
`
`(21) Appl. No.: 14/200,694
`
`(22) Filed:
`
`Mar. 7, 2014
`
`Publication Classification
`
`(51) Int. Cl.
`A6M5/34
`A6M 5/32
`(52) U.S. Cl.
`CPC ............. A61M 5/343 (2013.01); A61M 5/3293
`(2013.01)
`USPC .......................................................... 604/240
`
`(2006.01)
`(2006.01)
`
`ABSTRACT
`(57)
`A prefilled Syringe for injecting medicament into a patient
`includes a barrel constructed of a polymeric material, a can
`nula and a hub. The barrel has a diameter, a longitudinal axis,
`a proximal end and a distal end. The cannula has a proximal
`end and a tip opposite the proximal end. The proximal end of
`Related U.S. Application Data
`the cannula is fixed to the distal end of the barrel. The cannula
`is positioned generally coaxially with the longitudinal axis.
`-
`-
`pist5. 26 E.S.E. The hub is integrally formed with the distal end. The hub
`(60) 2.
`ation-in-part of application No 2/680,609, filed on
`includes a rib section and a cap. The rib section has a gener
`Mar. 29, 2010, now Pat. No. 8 49 6,862 filedas appli-
`ally cruciform cross-section taken along a rib plane. The rib
`Cation No PCTfUSO931 1 12 on Jan 15 2009
`plane is generally perpendicular to the longitudinal axis. The
`•
`als
`cap has a generally U-shaped cross-section taken along a
`(60) Provisional application No. 61/021,186, filed on Jan.
`longitudinal plane. The longitudinal plane is generally paral
`lel to the longitudinal axis.
`15, 2008.
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`Patent Application Publication
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`Jul. 3, 2014 Sheet 1 of 13
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`US 2014/O188053 A1
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`Patent Application Publication
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`Jul. 3, 2014 Sheet 2 of 13
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`US 2014/0188053 A1
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`Jul. 3, 2014 Sheet 3 of 13
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`US 2014/O188053 A1
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`Jul. 3, 2014
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`Sheet 6 of 13
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`US 2014/O188053 A1
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`Sheet 7 of 13
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`US 2014/O188053 A1
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`US 2014/O 188053 A1
`
`Jul. 3, 2014
`
`SYRINGE WITH CO-MOLDED HUBAND
`CANNULA
`
`CROSS-REFERENCE TO RELATED
`APPLICATIONS
`0001. This application is a divisional of U.S. patent appli
`cation Ser. No. 13/237,429, filed on Sep. 20, 2011, entitled
`“Syringe With Co-Molded Hub and Cannula, currently
`pending which is a continuation-in-part application of U.S.
`patent application Ser. No. 12/680,609, filed Mar. 29, 2010,
`now U.S. Pat. No. 8,496,862, which is a Section 371 of
`International Application No. PCT/US09/0311 12, filed Jan.
`15, 2009, which was published in the English language on Jul.
`23, 2009 under International Publication No. WO 2009/
`0.91895 A2 and claims priority to U.S. Provisional Patent
`Application No. 61/021,186, filed Jan. 15, 2008, the disclo
`sures of which are incorporated herein by reference in their
`entirety.
`
`BACKGROUND OF THE INVENTION
`0002 The present invention relates to a hub for a syringe
`that is co-molded with a cannula and a method for forming or
`co-molding the cannula to the Syringe barrel. The cannula is
`preferably a fine gauge cannula, which is co-molded to the
`Syringe barrel to form a staked needle device.
`0003. The process of bonding a cannula to a syringe barrel
`involves precisely positioning and then bonding the cannula
`to the Syringe without damaging the cannula. Bends or burrs
`in the cannula resulting from the manufacturing process can
`increase perceived pain of the patient. The cannula is prefer
`ably co-axial with the center or longitudinal axis of the
`Syringe. The cannula is also preferably bonded to the Syringe
`to withstand an approximately twenty-two Newton (22 N)
`pull test rating in accordance with the International Standards
`Organizations (ISO’s) standards.
`0004. The cannula of a syringe having a polymeric barrel
`is traditionally interference fit into a preformed barrel utiliz
`ing techniques similar to those used to manufacture Syringes
`having glass barrels. The cannula is often affixed to the
`Syringe by an adhesive when utilizing this method. Adhesive
`bonding to affix a cannula to the barrel of the Syringe may be
`undesirable in certain situations because the adhesive may
`contain chemicals that could leach into the medication in the
`Syringe. The medication may be prefilled in to the Syringe,
`resulting in potentially prolonged exposure of the medication
`to the adhesive. The leaching chemicals of the adhesive may
`have an adverse impact on the medication/biological com
`pound(s) maintained in the barrel of the Syringe. Such as
`altering the efficacy and/or stability of the Syringe contents
`that eventually enter the patient.
`0005. In order to avoid the use of an adhesive, the cannula
`is typically crimped near its proximal end and the Syringe
`barrel is insert molded over the proximal end of the cannula so
`that the Syringe molds over the crimped proximal end to
`securely grip and retain the cannula. Though crimping the
`proximal end may avoid the use of an adhesive, relatively fine
`gauge cannulas, for example twenty-seven to thirty (27-30)
`gauge cannulas cannot usually be crimped without poten
`tially damaging the cannula due to their small physical
`dimensions. Regardless of the attachment method, it is diffi
`cult to position, hold, and/or mount a fragile, fine gauge
`cannula without damaging the cannula.
`
`0006. It would be desirable to design, construct and
`employ a mechanism that holds the cannula, particularly a
`Small diameter cannula, during the insert molding process to
`attach the cannula directly to a polymeric syringe barrel with
`out the use of an adhesive or the need to crimp the cannula and
`without damaging the cannula. It is also desirable to construct
`a hub at the distal end of the barrel that effectively secures the
`cannula to the barrel and provides sufficient strength to with
`stand the operating conditions of the Syringe, while utilizing
`a cost-effective and efficient manufacturing process.
`
`BRIEF SUMMARY OF THE INVENTION
`0007 Briefly stated, the present application is directed to a
`prefilled Syringe for injecting medicament into a patient
`including a barrel constructed of a polymeric material, a
`cannula and a hub. The barrel has a diameter, a longitudinal
`axis, a proximal end and a distal end. The cannula has a root
`end and a tip opposite the root end. The root end is fixed to the
`distal end of the barrel. The cannula is positioned generally
`coaxially with the longitudinal axis. The hub is integrally
`formed or co-molded with the distal end. The hub includes a
`rib section and a cap. The rib section has a generally cruci
`form cross-section taken along a rib plane that is generally
`perpendicular to the longitudinal axis. The cap has a generally
`U-shaped cross-section taken along a longitudinal plane that
`is generally parallel to the longitudinal axis.
`0008. In another aspect, the present application is directed
`to a prefilled Syringe for injecting medicament into a patient.
`The Syringe includes a barrel constructed of a polymeric
`material, a cannula and a hub. The barrel has a diameter, a
`longitudinal axis, a proximal end and a distal end. The can
`nula has a root end and a tip opposite the root end. The root
`end is fixed to the distal end of the barrel. The cannula is
`positioned generally coaxially with the longitudinal axis. The
`hub is integrally formed with the distal end. The hub includes
`a rib section and a cap. The rib section includes a first pair of
`ribs and a second pair of ribs. The first pair of ribs has a
`generally H-shaped cross-section and the second pair of ribs
`has a generally rectangular-shaped cross-section. The can
`nula is co-molded with the rib section.
`
`BRIEF DESCRIPTION OF THE SEVERAL
`VIEWS OF THE DRAWINGS
`0009. The following detailed description of the invention,
`will be better understood when read in conjunction with the
`appended drawings. For the purpose of illustrating the inven
`tion, there are shown in the drawings embodiments which are
`presently preferred. It should be understood, however, that the
`invention is not limited to the precise arrangements and
`instrumentalities shown. In the drawings:
`0010 FIG. 1A is a perspective view of a staked needle
`formed through the use of a collet mechanism in accordance
`with a first preferred embodiment of the present invention;
`0011
`FIG. 1B is an enlarged rear elevational view of the
`staked needle shown in FIG. 1A:
`0012 FIG. 1C is an enlarged front elevational view of the
`staked needle shown in FIG. 1A:
`0013 FIG. 1D is a side elevational view of the staked
`needle shown in FIG. 1A:
`0014 FIG. 1E is an enlarged cross-sectional view of the
`staked needle shown in FIG. 1A taken from within circle 1F
`of FIG. 1B:
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`Jul. 3, 2014
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`0015 FIG.1F is a greatly enlarged cross-sectional view of
`the needle end of the staked needle shown in FIG. 1A taken
`from within circle 1F of FIG. 1E;
`0016 FIG. 2A is a greatly enlarged perspective view of a
`needle tip of the staked needle shown in FIG. 1A:
`0017 FIG. 2B is a greatly enlarged side elevational view
`of the needle tip shown in FIG. 2A;
`0018 FIG. 2C is a greatly enlarged side elevational view
`of the proximal end of the needle shown in FIG. 2A;
`0019 FIG. 3 is a semi-transparent perspective view of a
`collect mechanism in accordance with the first preferred
`embodiment of the present invention;
`0020 FIG. 4 is a perspective view of a partial collect
`mechanism shown in FIG.3 following injection molding with
`the mold removed;
`0021
`FIG. 5A is a greatly enlarged perspective view of
`cannula guides of the collet mechanism shown in FIG.3 in an
`open position;
`0022 FIG.5B is a greatly enlarged perspective view of the
`cannula guides shown in FIG. 5A in a closed position;
`0023 FIG. 6 a perspective schematic view of the collect
`mechanism and a portion of the mold in an open position;
`0024 FIG. 7 is a perspective schematic view of the collect
`mechanism and a portion of the mold shown in FIG. 6 in a
`closed position;
`0025 FIG. 8 is a semi-transparent perspective view of a
`collect mechanism in accordance with a second preferred
`embodiment of the present invention;
`0026 FIG. 9 is a top plan view of the collect mechanism
`shown in FIG. 8:
`0027 FIG. 10 is a perspective view of cannula guides of
`the collect mechanism shown in FIG. 8 in a closed position;
`0028 FIG. 11 is a cross sectional view of the collect
`mechanism shown in FIG.3 and mold components;
`0029 FIG. 12 is a greatly enlarged cross sectional view of
`the collect mechanism and mold shown in FIG. 11 taken
`within circle 12 of FIG. 11;
`0030 FIG. 13 is a semi-transparent perspective view of the
`mold encasement for the collet and mold components shown
`in FIG. 11;
`0031
`FIG. 14 is a left-side elevational view of a syringe in
`accordance with a third preferred embodiment of the present
`invention;
`0032 FIG. 15 is a cross-sectional view of the syringe of
`FIG. 14, taken along line 15-15 of FIG. 14;
`0033 FIG. 16A is a magnified front perspective view of a
`distal end portion of the syringe of FIG. 14, taken from within
`dashed circle 16 of FIG. 14;
`0034 FIG.16B is a magnified left-side elevational view of
`a distal end portion of the syringe of FIG. 14, taken from
`within dashed circle 16 of FIG. 14;
`0035 FIG. 17 is a cross-sectional view of a rib section of
`the syringe of FIG. 14, taken along line 17-17 of FIG. 16B:
`and
`0.036 FIG.18 is a cross-sectional view of the rib section of
`the syringe of FIG. 14, taken along line 18-18 of FIG. 16B.
`
`DETAILED DESCRIPTION OF THE INVENTION
`0037 Certain terminology is used in the following
`description for convenience only and is not limiting. The
`words “right”, “left”, “lower and “upper designate direc
`tions in the drawings to which reference is made. The words
`“inwardly” or “distally” and “outwardly” or “proximally”
`refer to directions toward and away from, respectively, the
`
`geometric center or orientation of the Syringe and related
`parts thereof. Unless specifically set forth herein, the terms
`“a”, “an and “the are not limited to one element but instead
`should be read as meaning “at least one'. The terminology
`includes the words noted above, derivatives thereof and
`words of similar import.
`0038 Referring to the drawings, wherein like numerals
`indicate like elements throughout, there is shown in FIGS.3-7
`and 11-13 a first preferred embodiment of a collet mechanism
`10. The collet mechanism 10 is used to position and hold a
`cannula 12 in place during insert molding of a staked needle
`or syringe, generally 14, without damaging the cannula 12.
`0039 Referring to FIGS. 1A-2C and 14, the staked needle
`or syringe 14, 14 is constructed of a polymeric barrel 16, 16
`that is directly insert molded over the cannula 12, 12'. The
`syringe 14 of the third preferred embodiment has similar
`features to the syringe 14 of the first preferred embodiment
`and like reference numerals are utilized to identify like ele
`ments of the syringes 14, 14 of the first and third embodi
`ments with the prime symbol () utilized to distinguish the
`elements of the third preferred embodiment from the ele
`ments of the first preferred embodiment. The barrel 16, 16' is
`preferably constructed of a transparent cyclic olefin copoly
`mer or polymer (COC or COP). The hub 200 or distal tip 16a
`of the barrel 16, 16' extends over and is preferably co-molded
`with a proximal end 12b of the cannula 12, 12'. The cannula
`12, 12' is to be attached to the distal tip 16a or hub 200 of the
`barrel 16, 16' that is directly insert molded over the cannula
`12, 12'. The distalend 17 or hub 200 is generally hollow, so as
`to form a sleeve around the cannula 12, 12" (FIGS. 1E, 1F and
`14). Hollowing out the interior of the distal end 17 or hub 200
`around the cannula 12, 12" reduces the amount of polymeric
`material in contact with the cannula 12, 12' and therefore
`further reduces the cooling time required for the insert mold
`ing process, as described below. The hub 200 is sufficiently
`sized and tapered to allow for a cannula or needle shield 25,
`generally manufactured for use with staked glass needles, to
`attach to the hub 200. Specifically, the needle shield 25 is
`preferably removably mountable to a cap 204 of the hub 200.
`0040. Referring specifically to FIGS. 2A-2C and 14, the
`cannula 12, 12' is preferably a fine gauge hollow metallic
`needle, for example, a twenty-seven to thirty (27-30) gauge
`needle. The twenty-seven (27) gauge needle or cannula 12.
`12' typically has a nominal outer diameter of sixteen thou
`sandths inches to one hundred sixty-five hundred thousands
`inches (0.0160-0.0165 in) and a nominal inner diameter of
`seventy-five hundred thousandths inches to ninety hundred
`thousandths inches (0.0075-0.0090 in). A thirty (30) gauge
`needle or cannula 12, 12' typically has a nominal outer diam
`eter of one hundred twenty hundred thousandths inches to one
`hundred twenty-five hundred thousandths inches (0.0120-0.
`0.125 in) and a nominal inner diameter of fifty-five hundred
`thousandths inches to seventy hundred thousandths inches
`(0.0055-0.0070 in). The interior lumen 13 of the cannula 12,
`12' is preferably straight. The cannula 12, 12" preferably has a
`tip 12a, 12a' with a three-bevel grind, meaning that the tip
`12a, 12a' is tapered at three distinct angles to reduce the pain
`perceived by a patient. However, the tip 12a, 12a' is not
`limited to being three-bevel ground and may have nearly any
`configuration and shape that is able to be inserted into the
`patient for delivery of the medicament into the patient.
`0041 A plurality of notches 18 are preferably formed on
`the outer surface of the proximal end 12b of the cannula 12.
`12. The notches 18 preferably extend radially inwardly and
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`are axially spaced apart from each other. The notches 18 are
`preferably machined into the proximal end 12b of the cannula
`12, 12'. The notches 18 aid in affixing or securing the proxi
`mal end 12b of the cannula 12, 12' to the tip 16a or hub 200 of
`the barrel 16, 16' because the polymeric material forming the
`distal end 17 or hub 200 flows into and fills in the notches 18
`during the molding process, as described below, to provide
`enhanced friction and gripping force between the proximal
`end 12b and the distal end 17 or hub 200. Because the cannula
`12, 12" may generally not be crimped without potentially
`damaging the cannula 12, 12" due to its size, the notches 18,
`which are formed in the cannula 12, 12 generally replace the
`function of crimping the cannula 12, 12. As shown in FIG.1F,
`a portion 12c of the proximal end 12b of the cannula 12, 12
`extends into a hollow of the barrel 16, 16 due to the molding
`process, as described further below. At least a portion of the
`proximal end 12b of the cannula 12, 12 may be textured or
`roughened (shown in FIG. 2C with cross hatching) by a
`mechanical or chemical Surface treatment to further enhance
`the gripping force of the proximal end 12b of the cannula 12.
`12' and to better secure the proximal end 12b to the distal end
`17 or hub 200 near the barrel 16, 16'. Though the above
`described cannula 12, 12' is preferred, it is within the spirit
`and scope of the present invention that any sized and shaped
`cannula 12, 12 may be used.
`0042. Referring specifically to FIGS. 3-5B, the collet
`mechanism 10 has first and second axially extending flexible
`arms 38, 40 that form an expandable internal cavity 46 (see
`FIGS. 6 and 12), but may include any number of flexible
`arms. Preferably, the collect mechanism 10 further includes
`third and fourthflexible arms 42, 44. Each flexible arm 38, 40,
`42, 44 has an attached proximal end 38a, 40a, 42a (the proxi
`mal end of the fourth flexible arm 44 obstructed from view)
`and a free or unattached distal end 38b, 40b, 42b, 44b. The
`flexible arms 38, 40, 42, 44 may be flexed inwardly and
`outwardly with the greatest deflection occurring toward the
`distalends 38b, 40b, 42b, 44b. The flexible arms 38, 40, 42,44
`are in a closed position (FIGS. 3 and 7) when the distal ends
`38b, 40b, 42b, 44b are flexed inwardly, towards the internal
`cavity 46. The flexible arms 38, 40, 42, 44 are in an open
`position (FIG. 6) when the distal ends 38b, 40b, 42b, 44b of
`the flexible arms 38, 40, 42, 44 are positioned away from the
`internal cavity 46 (e.g., flexed outwardly). The open position
`of the collet mechanism 10 is preferably the unrestrained
`state, meaning that the distal ends 38b, 40b, 42b, 44b are
`untouched, and the closed position of the collet mechanism
`10 is preferably the restrained position, meaning that the
`distal ends 38b, 40b, 42b, 44b are forced together by an
`outside force, though the opposite configuration may be used
`if desired.
`0043. Referring specifically to FIGS.5A and 5B, the first
`and second flexible arms 38, 40 include first and second
`cannula guides 48.50, respectively. The first cannula guide 48
`is preferably directly opposed from the second cannula guide
`50. Preferably, the third and fourth flexible arms 42, 44
`include third and fourth cannula guides 52, 54, respectively,
`the third cannula guide 52 preferably being directly opposed
`from the fourth cannula guide 54. The cannula guides 48.50,
`52, 54 are preferably comprised of a polytetrafluoroethylene
`material, a plastic with nonstick properties such as
`TEFLONR, that is gentle on the cannula 12, but resists the
`elevated temperature of the mold 20. However, the cannula
`guides 48, 50, 52, 54 may be comprised of any heat resistant
`polymeric material or a stainless steel.
`
`0044) The cannula guides 48, 50, 52, 54 are mounted
`proximate and positioned through the distal ends 38, 40, 42.
`44 of the respective flexible arms 38, 40, 42, 44 and extend
`radially at least partially into the expandable internal cavity
`46. The cannula guides 48.50, 52.54 are preferably generally
`orthogonal to the flexible arms 38, 40, 42, 44. The cannula
`guides 48.50, 52.54 clamp a portion of the cannula 12 to hold
`the cannula 12 in place when the flexible arms 38, 40, 42, 44
`are in the closed position (FIG. 5B). The cannula guides 48.
`50, 52, 54 are spaced away from the cannula 12 when the
`flexible arms 38, 40, 42.44 are in the open position (FIG.5A).
`0045. A position of the cannula guides 48, 50, 52, 54 is
`preferably adjustable with respect to the flexible arms 38, 40.
`42, 44 and the internal cavity 46 with a tool, such as an Allen
`Wrench, by inserting the tool into an adjustment opening 60
`of the cannula guides 48, 50, 52, 54 to position the cannula
`guides 48, 50, 52, 54 at a predetermined depth into the inter
`nal cavity 46. Because the size of the cannula 12 may change
`and the size of the collect mechanism 10 may vary slightly,
`the adjustability of the position of the cannula guides 48.50,
`52, 54 allows a user to adjust and set the pressure exerted on
`the cannula 12 and the resulting force with which the cannula
`guides 48, 50, 52, 54 contact the cannula 12. Preferably, the
`position of the cannula guides 48.50, 52, 54 may be adjusted
`in accordance with a predetermined force. Thus, one can
`ensure that the cannula guides 48, 50, 52, 54 sufficiently
`position and hold the cannula 12 in the desired position with
`out damaging (i.e. bending, crimping or Scratching) the can
`nula 12, but with sufficient force to retain the cannula 12
`without allowing its movement during the injection or insert
`molding process. Preferably, the flexible arms 38, 40, 42, 44
`exert a predetermined amount of force upon the cannula 12
`when they are in the closed position and in contact with the
`cannula 12. Such that the cannula 12 is not damaged and the
`sharpness of the tip 12a of the cannula 12 is not altered during
`the molding process. However, it is within the spirit and scope
`of the present invention that the cannula guides 48.50, 52, 54
`be immovably mounted to the respective flexible arm 38, 40.
`42, 44.
`0046 Referring again to FIGS.5A and 5B, each cannula
`guide 48.50, 52.54 preferably has a sloped mating surface 56
`with an indentation or step 58 foamed in the center, but may
`have any mating configuration, Such as mating V-shaped
`members. As shown in FIG. 5B, as the flexible arms 38, 40,
`42, 44 move into the closed position, the first and second
`cannula guides 48, 50 come into mating contact with each
`other and the third and fourth cannula guides 52.54 come into
`mating contact with each other, and all of the cannula guides
`48,50, 52,54 come into contact with the cannula 12, such that
`the cannula 12 slides along the sloped mating Surface 56 into
`the indentation 58 of each of the cannula guides 48.50, 52,54.
`When the flexible arms 38, 40, 42, 44 are in the closed
`position, each indentation 58 abuts the cannula 12, such that
`the cannula 12 is positioned and held firmly along the center
`of the collet mechanism 10, generally in alignment with a
`central longitudinal axis 10a of the collet mechanism 10, and
`inline with the centerline or longitudinal axis 14a of the
`staked needle or syringe 14. The cannula guides 48.50, 52.54
`may mate together in any manner, Such as all four guides
`mating together, as long as the cannula 12 is sufficiently held
`in place during the injection or insert molding process.
`0047 Referring to FIGS. 8-10, a second preferred
`embodiment of the collet mechanism 110 is shown. The collet
`mechanism 110 is similar to the first preferred embodiment of
`
`Abbott Ex. 1011 - 17/21
`
`

`

`US 2014/O 188053 A1
`
`Jul. 3, 2014
`
`the collet mechanism 10, except that the cannula guides 148,
`150, 152,154 are each spring biased toward the open position.
`Preferably, each cannula guide 148, 150, 152, 154 includes a
`coil spring 162 to inwardly spring bias the cannula guides
`148, 150, 152, 154. The collect mechanism 110 includes
`similar elements to the collect mechanism 10 and such ele
`ments have been similarly numbered with the addition of a
`leading one (1). A mounting member 164 is secured to the
`distal ends 138b, 140b, 142b, 144b of each of the flexible
`arms 138, 140, 142,144. The coil springs 162 are positioned
`between the mounting members 164 and the cannula guides
`148,150, 152,154 such that the cannula guides 148,150, 152,
`154 may accommodate differently sized cannulas 12 or may
`be used in order to ensure that the cannula guides 148, 150,
`152, 154 contact and firmly hold the cannula 12 without the
`need for adjustment. The springs 162 are preferably replace
`able Such that the springs 162 having the desired pressure are
`used. It is within the spirit and scope of the present invention
`that the first and second embodiments of the collet mecha
`nism 10, 110 be combined such that the cannula guides 48.
`50, 52,54 and 148, 150, 152, 154 may be both adjustable and
`spring biased.
`0048 Referring to FIGS. 1A-1F and 11-13, the staked
`needle or Syringe 14, 14' is preferably manufactured in an
`insert mold 20 (FIG. 13). The insert mold 20 includes an
`A-side mold 22 and a B-side mold 24, separable along a
`parting line 26, shown in FIG. 11. A core member 28, pref
`erably comprised of steel, extends from the B-side mold 24
`upwardly and into a mold cavity 30 in the A-side mold 22. The
`mold cavity 30 is in the shape of the to-be-formed barrel 16,
`16'. A cooling cavity 32 preferably extends through the center
`of the core member 28 to cool the core member 28 during
`molding. The A-side mold 22 includes a conically tapered
`receiving port 34 positioned above the core member 28 where
`the distal end 17 or hub 200 is to be formed. The tapered
`receiving port 34 at least partially surrounds a portion of the
`cannula 12, 12.
`0049 Referring to FIGS. 6, 7, 11, 12 and 14, during mold
`ing of the staked needle or syringe 14, 14", a robotic arm (not
`shown) transports the cannula 12, 12' and places the proximal
`end 12b of the cannula 12, 12" onto a recessed tip 28a of the
`core member 28. The tip 28a of the core member 28 receives
`the portion 12c of the cannula 12, 12 and positions the can
`nula 12, 12 generally inline with a center line or longitudinal
`axis 14a, 14a (see FIG.1F) of the staked needle 14, 14'. The
`A-side mold 22 is inserted over the steel core member 28 such
`that the A-side mold 22 contacts the B-side mold 24 along the
`parting line 26. The tip 12a, 12a' of the cannula 12 extends at
`least partially through the receiving port 34.
`0050. Once the cannula 12, 12" and A-side mold 22 have
`been positioned on the core member 28, the collet mechanism
`10, preferably having flexible arms 38, 40, 42, 44 with distal
`ends 38b, 40b, 42b, 44b, is inserted through the A-side mold
`22 over the beveled tip 12a, 12a' of the cannula 12, 12", such
`that the distal end 10a of the collet mechanism 10 is guided by
`the tapered receiving port 34 to move the collet mechanism 10
`into the closed position. More specifically, the distal ends
`38b, 40b, 42b, 44b of the flexible arms 38, 40, 42, 44 are
`inserted into the tapered receiving port 34 which flexes the
`flexible arms 38, 40, 42, 44 towards the internal cavity 46 as
`the distal ends 38b, 40b, 42b, 44b slide along the taper of the
`tapered receiving port 34, until the collet mechanism 10 abuts
`the A-side mold 22. Once the collet mechanism 10 abuts the
`A-side mold 22, or is otherwise stopped, and the distal ends
`
`38b, 40b, 42b, 44b are fully received in the receiving port 34
`as shown in FIGS. 11 and 12, the collet mechanism 10 is in the
`closed position. In the closed position, the cannula guides 48.
`50, 52, 54 clamp a portion of the cannula 12 to hold the
`cannula 12 generally in alignment with the central longitudi
`nal axis 10a of the collet mechanism 10 and with a central
`longitudinal axis 28a of the core member 28. The cannula 12
`extends beyond the distal ends 38b, 40b, 42b, 44b of the
`flexible arms 38, 40, 42, 44 and, thus, the collet mechanism 10
`generally does not damage the beveled tip of the cannula 12.
`Further, in the closed position, the cannula 12 is positioned
`and firmly held in the center of the internal cavity 46 and is
`generally inline with the centerline or longitudinal axis 14a of
`the staked needle 14 (see FIG. 1D).
`0051 Referring specifically to FIG. 11, once the collet
`mechanism 10 is in place within the A-side mold 22 of the
`insert mold 20, molten polymeric material (not shown) is
`injected into the mold cavity 30 proximate the parting line 26
`(dispensing line not shown) until the mold cavity 30 is com
`pletely filled with the molten polymeric material. The insert
`mold 20 operates at a temperature of approximately two
`hundred thirty degrees Fahrenheit (230°F.). The insert mold
`20 remains closed and the molten polymeric material is
`allowed to cool to a substantially solidified state over at least
`the proximal end of the cannula 12. It may take approximately
`thirty seconds (30 sec.) for the polymeric material to substan
`tially solidify. Once the polymeric material is cooled to a
`semi-hardened object, and preferably, a fully hardened
`object, the collet mechanism 10 and the A-side mold 22 are
`removed, such that the cannula guides 48, 50, 52, 54 release
`the cannula 12. The staked needle 14 and attached cannula 12
`are then removed from the steel core member 28 by a robotic
`arm (not shown), and the polymeric material is allowed to
`further cool and solidify, if necessary, to a fully hardened
`object.
`0052 Referring to FIGS. 1A-1F and 14-18, the barrel 16
`of the third preferred embodiment is constructed of a poly
`meric material and includes a diameter D, alongitudinal axis
`or center line 14a', a proximal end 16b', and a distal end 16c'.
`The barrel 16' is preferably constructed of a transparent cyclic
`olefin copolymer or a transparent cyclic olefin polymer. The
`barrel 16' is not limited to constructions of cyclic olefin
`copolymer orcyclic olefin polymerand may be constructed of
`nearly any polymeric material that may be molded into the
`general size and shape of the barrel 16' is able to take on the
`general size and shape of the barrel 16" and withstand the
`normal operating conditions of the barrel 16'. The barrel 16
`includes a hollow section wherein the medicament is held
`prior to injection into the patient.
`0053. The cannula 12 of the third preferred embodiment
`has the proximal end 12b' with