(12) United States Patent
`Burroughs et al.
`
`US006221046B1
`US 6,221,046 B1
`(io) Patent No.:
`(45) Date of Patent:
`*Apr. 24,2001
`
`(54) RECYCLABLE MEDICATION DISPENSING
`DEVICE
`
`(75)
`
`Inventors: Andrew Burroughs, Kenosha, WI
`(US); Dave Hixson, Evanston, IL (US);
`Andrew Hodge, San Francisco, CA
`(US)
`
`(73) Assignee: Eli Lilly and Company, Indianapolis,
`IN (US)
`
`( * ) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`This patent is subject to a terminal dis­
`claimer.
`
`(21) Appl. No.: 08/678,528
`(22) Filed:
`Jul. 9, 1996
`
`Related U.S. Application Data
`
`(52) U.S. CI.
`
`(63) Continuation-in-part of application No. 08/399,764, filed on
`Mar. 7, 1995, now abandoned.
`... A61M 1/00; A61M 5/00;
`(51) Int. CI.7
`A61M 5/315
`604/153; 604/207; 604/220;
`604/232; 604/208
`604/207, 208,
`(58) Field of Search
`604/209, 210, 211, 181, 186, 187, 232,
`224, 218, 220, 228, 229, 71, 72, 404, 246;
`222/309, 390, 391
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`11/1983 Paton .
`4,413,760
`6/1986 Rex et al. .
`4,592,745
`4,865,591 * 9/1989 Sams .
`4,883,472
`11/1989 Michel .
`4,936,833 * 6/1990 Sams .
`4,973,318 * 11/1990 Holm et al. .
`5,017,190
`5/1991 Simon et al. .
`
`604/209
`
`5,042,977 *
`5,085,641
`5,092,842 *
`5,104,380
`5,112,317
`5,114,406 *
`5,232,459
`5,244,465
`5.279.585
`5.279.586
`5,295,976
`5,304,152
`5,308,340
`
`8/1991
`Bechtold .
`2/1992 Sarnoff et al. .
`3/1992 Bechtold et al.
`4/1992 Holman et al. .
`5/1992 Michel .
`5/1992 Gabriel et al. .
`8/1993 Hjertman .
`9/1993 Michel .
`1/1994 Balkwill .
`1/1994 Balkwill .
`3/1994 Harris .
`4/1994 Sams .
`5/1994 Harris .
`
`(List continued on next page.)
`
`FOREIGN PATENT DOCUMENTS
`349 592
`5/1988 (EP) .
`498 737
`8/1992 (EP) .
`WO 92/18179
`10/1992 (WO) .
`4/1993 (WO) .
`WO 93/07922
`7/1994 (WO) .
`WO 94/15120
`
`Primary Examiner—Richard K. Seidel
`Assistant Examiner—Michael J Hayes
`(74) Attorney, Agent, or Firm—Michael T. Bates
`ABSTRACT
`
`(57)
`
`A multi-use medication dispensing pen made of a plastic
`material that is recyclable after the contents of the medica­
`tion cartridge have been exhausted. The pen is made of a
`minimal number of parts, which include a housing, a dial
`mechanism, a generally cylindrical button assembly located
`within the proximal end of the dial mechanism, an internally
`threaded nut, and an externally threaded leadscrew The pen
`is arranged so that the dial mechanism must be rotated to the
`zero-dose position prior to setting a dose. The pen includes
`a lockout mechanism that prevents the dial mechanism from
`being inadvertently depressed during dosing. The pen fur­
`ther includes a mechanism that limits the maximum dosage
`that can be dialed up and a mechanism that prevents the user
`from dialing up a dosage greater than that remaining in the
`cartridge.
`
`23 Claims, 4 Drawing Sheets
`
`84
`
`7i
`
`8? 97
`
`158
`HO
`) 102 / 37 192
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`216
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`210
`206
`
`224
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`54
`91
`
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`38
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`112
`37
`
`184 42
`170 / 204 194 iQo
`36
`
`214
`
`218
`
`44
`
`222
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1013. p. 1, of 17
`
`

`

`US 6,221,046 B1
`Page 2
`
`U.S. PATENT DOCUMENTS
`5,370,629
`12/1994 Michel et al. .
`5,383,865 *
`1/1995 Michel .
`5,582,598 * 12/1996 Chanoch
`5,591,136 * 1/1997 Gabriel .
`
`5,611,783 *
`5,626,566 *
`5,938,642 *
`
`3/1997 Mikkelsen
`5/1997 Petersen et al. ..
`8/1999 Burroughs et al.
`
`604/211
`604/208
`604/208
`
`604/208
`604/208
`
`* cited by examiner
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1013. p. 2, of 17
`
`

`

`U.S. Patent
`
`Apr. 24,2001
`
`Sheet 1 of 4
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`US 6,221,046 B1
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`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1013. p. 3, of 17
`
`

`

`U.S. Patent
`
`Apr. 24,2001
`
`Sheet 2 of 4
`
`US 6,221,046 B1
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`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1013. p. 4, of 17
`
`

`

`U.S. Patent
`
`Apr. 24,2001
`
`Sheet 3 of 4
`
`US 6,221,046 B1
`
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`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1013. p. 5, of 17
`
`

`

`U.S. Patent
`
`Apr. 24,2001
`
`Sheet 4 of 4
`
`US 6,221,046 B1
`
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`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1013. p. 6, of 17
`
`

`

`1
`RECYCLABLE MEDICATION DISPENSING
`DEVICE
`
`US 6,221,046 B1
`
`CROSS REFERENCE TO RELATED
`APPLICATION
`This is a of U.S. patent application Ser. No. 08/399,764,
`titled RECYCLABLE MEDICATION DISPENSING
`DEVICE, which was filed on Mar. 7,1995, now abandoned.
`
`2
`retaining the container of liquid within the housing. The
`plunger rod passes through the noncylindrical opening in the
`collar and is prevented from rotating with respect to the
`housing by the collar. A hollow cap envelopes the plunger
`5 rod opposite the container of liquid. The skirt of the hollow
`cap extends inside the housing. The cap includes a threaded
`interior surface which movably engages the plunger rod for
`calibrated adjustment relative thereto. A stop is provided
`within the housing, and a distal facing surface is provided on
`10 the hollow cap for contacting the stop upon linear movement
`BACKGROUND OF THE INVENTION
`of the cap and plunger rod as a unit toward the container to
`1. Field of the Invention
`dispense liquid therefrom. In operation, the cap is rotated in
`a counterclockwise direction causing the threads of the cap
`The present invention relates generally to medical dis­
`to travel along the threaded portion of the rod. This rotation
`pensing devices and, more particularly, to recyclable dis­
`pensing devices that permit selectively measured dosages of 15 does not cause displacement of the plunger rod with respect
`to the housing, but backs the distal end of the proximal cap
`a liquid to be dispensed.
`portion away from a stop shoulder on the inside of the
`2. Background of the Related Art
`housing. When the cap has been positioned to the desired
`Patients suffering from diseases such as diabetes must
`dosage, pressure is applied to the end of the cap for causing
`inject themselves several times each day with an insulin
`20 it to move linearly toward the distal end of the housing until
`solution. Since the volume of insulin solution to be injected
`a shoulder defined by a radially exposed portion of the distal
`varies from injection to injection, it is necessary for such
`end contacts a stop.
`patients to be able to measure a precise volume of insulin.
`Finally, in U.S. patent application Ser. No. 08/399,764,
`Diabetics have conventionally used a syringe for injection of
`the parent application to the present application, a medica-
`insulin. However, it is difficult to control the operation of the
`25 tion dispensing device is disclosed which includes a dial
`syringe as well as the quantity of drug injected.
`telescopingly disposed within a housing wherein the dial can
`In order to permit a diabetic to measure and administer a
`be engaged with a nut disposed on a lead screw. The lead
`more accurate and controlled dosage, injector pens have
`screw, in conjunction with the dial and the nut, ultimately
`been developed which enable a particular dosage to be
`serves as a plunger to eject the medication from a cartridge
`accurately and conveniently measured. Generally, these
`30 contained within the device. If the dial is rotated while not
`pens are secured onto a cartridge having a particular quantity
`engaging the nut, a dosage will not be set, and in order to
`of liquid medication sealed therein. The cartridge includes a
`commence an injection, a button assembly must be
`plunger and a mechanism for advancing the plunger in the
`depressed relative to the dial to disengage the dial from the
`cartridge in a manner to dispense the medication. Injector
`housing. The disclosure of U.S. patent application Ser. No.
`pens may be reusable or disposable. In reusable pens, a user
`35 08/399,764 is incorporated by reference herein.
`can change a spent cartridge and reset the leadscrew of the
`pen back to its initial position. In a disposable pen, the
`SUMMARY OF THE INVENTION
`cartridge is permanently captured in the pen which is
`The present invention provides a medication injection
`disposed of after the contents of the cartridge have been
`40 device comprising a housing, a dose setting mechanism
`exhausted.
`within the housing, and a delivery mechanism within the
`One such disposable pen that has functioned very
`housing for advancing a leadscrew. A liquid medication
`adequately is disclosed in U.S. Pat. No. 5,295,976.
`product is housed in a variable volume cartridge within the
`Specifically, a dispensing device is disclosed and includes an
`housing of the device. Upon actuation of the delivery
`internally threaded collar and an externally threaded plunger
`rod. In order to set a dosage of medication to be delivered, 45 mechanism, the leadscrew is advanced against a movable
`piston in the cartridge to advance the piston, thereby causing
`the collar is rotated thereby causing displacement of the
`a preset quantity of medication to be delivered from the
`collar toward the proximal end of the injection device.
`needle of the device.
`Rotation of the collar causes the integral cap to become
`In one embodiment, the device is made entirely out of a
`effectively displaced both rotationally and axially toward the
`proximal end of the pen. As this displacement occurs, the 50 recyclable plastic material, except for the glass container,
`steel needle and paper label. The dose setting mechanism
`segment of the dose-indicating scale which is visible
`comprises a dial mechanism including a clutching device for
`through a window varies to show a linear increase in the
`engaging and disengaging a generally cylindrical internally
`number to indicate an increased dosage of liquid to be
`threaded nut, which is threaded onto an externally threaded
`dispensed. Once the desired dosage is selected, a force is
`applied to the end of the cap causing a linear displacement 55 leadscrew. A dose is set by rotating the nut with respect to
`of the cap, integral plunger rod, and piston to dispense liquid
`the leadscrew. The nut is rotated by rotating the dial mecha­
`nism. However, the nut must be engaged with the dial
`from the container. The dispensing displacement of the
`mechanism so that rotating the dial mechanism also rotates
`plunger rod is halted by abutting contact between the cap
`and a stop element.
`the nut. The clutching device comprises a series of splines on
`In U.S. Pat. No. 5,308,340, another recyclable injection 60 the inner cylindrical surface of the dial mechanism which
`axially engage corresponding splines on the outer surface of
`device is disclosed. In particular, a plunger rod is received
`the nut. The splines are engaged with one another by
`within the housing for exerting a force on a piston closing a
`retracting the dial mechanism with respect to the nut after
`second end of the container. The plunger rod has a noncy­
`the dial mechanism has been rotated to its zero-dose posi­
`lindrical cross section with a first surface including threads
`tion.
`and a second surface which can, optionally, include a series 65
`of ratchet teeth. A collar is received within the housing
`The dial mechanism includes a mechanism that prevents
`the user from retracting the dial mechanism prior to rotating
`adjacent the second end of the container for permanently
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1013. p. 7, of 17
`
`

`

`US 6,221,046 B1
`
`4
`3
`its end-of-injection position. If the nut were allowed to rotate
`the dial mechanism to its zero-dose position. The dial
`while the dial mechanism was in the end-of-injection
`mechanism cannot be pulled out in any radial position other
`position, the nut would in turn move along the leadscrew and
`than the zero-dose radial position due to the interference
`potentially result in an inaccurate dosage. The present device
`formed between threads formed on elastically deformable
`therefore provides a plurality of prongs around the circum-
`tabs extending from the dial mechanism and a raised surface 5
`ference of the distal nut flange and a corresponding plurality
`formed on the inner circumference of the housing. The
`of ribs on the inner circumference of the housing distal end.
`threads are specifically shaped and arranged such that they
`In the end-of-injection position, the prongs engage the ribs
`align with openings in the raised surface in only one
`position, the zero-dose position, in the 360° circumference
`to allow the dial mechanism to rotate while maintaining the
`rotational position of the nut, and when the dial mechanism
`of the housing.
`is in the dose-setting position, the dial mechanism is
`The device includes a mechanism that limits the maxi­
`retracted and the nut prongs are permitted to flex away from
`mum dosage that can be set. This mechanism comprises a
`the ribs to allow for the nut to rotate about and axially move
`helical groove formed in the housing and a pair of flexible
`along the leadscrew.
`tabs, having threads integral therewith, formed in the dial
`An advantage of the medication dispensing device of the
`mechanism. Upon rotating the dial mechanism to set a dose,
`the dial mechanism is retracted with respect to the housing 15 present invention is that the dosing function is locked out
`until the dial mechanism has been rotated to its zero-dose
`and the threads on the dial tabs ride up the internal housing
`position, thereby enabling the dial mechanism to be
`groove. Once the dial threads reach the proximal end of the
`retracted to the dose-setting position and ensuring an accu­
`housing groove, further rotation of the dial mechanism is
`rate dosage.
`prohibited, thereby indicating to the user that the maximum
`Another advantage of the present invention is that the
`dosage has been dialed.
`device is an inexpensive recyclable pen that is designed to
`The device further includes a mechanism for automati­
`allow a user to dose in single unit increments, which are each
`cally locking out the dial mechanism from an inadvertent
`displayed in a single unit display.
`injection after the dial mechanism has been retracted to set
`Another advantage of the present invention is that the
`a dosage. This lockout mechanism comprises the above- 25
`end-of-injection click indicator is coordinated with the end-
`mentioned threads in the dial mechanism that ride up the
`of-injection stop to provide increased accuracy in determin­
`helical groove in the housing upon retracting the dial mecha­
`ing the end of a injection.
`nism with respect to the housing. The interference fit formed
`Another advantage of the present invention is that the
`by the threads in the groove prevents forward movement of
`the dial mechanism in the event of inadvertent pressure 30 device includes a dosage lockout mechanism that prevents
`being applied to the end of the dial mechanism. The lockout
`an inadvertent delivery of a dosage of medication,
`mechanism is released by a button that is disposed within the
`A further advantage of the present invention is that the
`proximal end of the dial mechanism. The button is sized and
`insufficient remaining dose mechanism comprises a radial
`configured so that it must be depressed upon initiating an
`stop which ensures that the user cannot dial up a dosage
`injection. Upon depressing the button, the button moves 35
`greater than that remaining in the cartridge.
`forward so that the flexible tabs and associated threads move
`Yet another advantage of the present invention is that the
`inward and out of engagement with the groove to allow the
`device is made of inexpensive materials and is nearly 100%
`dial mechanism to move relative to the housing.
`recyclable after the contents of the cartridge have been
`The device also includes an "end-of-injection click" fea­
`depleted.
`ture which includes an extension on one of the two flexible 4Q
`Yet another advantage of the present invention is that the
`tabs of the dial mechanism which, when the button is
`device includes a mechanism to prevent rotation of the nut
`pressed, is pushed radially out. This finger falls within a
`while the dial mechanism is in the end-of-injection position.
`separate groove in the housing as the end-of-injection stop
`The present invention, in one form thereof, provides a
`surface of the nut engages the corresponding stop surface on
`medication injection pen having a distal end and a proximal
`the housing, thereby producing an audible "click" indicating 45 end. The pen comprises a housing, a cartridge, a drive stem,
`that the entire dosage has been injected.
`a rotatable nut, and a dial mechanism. The cartridge is
`The housing further includes radially inwardly extending
`mounted within the housing and includes a piston, an exit,
`tangs at the distal end of the housing which engage ratchet
`and injectable medication between the piston and the exit.
`teeth in the leadscrew to prevent the leadscrew from backing
`The drive stem is disposed within the housing in axial
`up in the proximal direction. These tangs are in constant 50 alignment with the cartridge and is adapted to axially move
`engagement with the leadscrew, thereby preventing the
`through the cartridge for driving the piston and ejecting
`leadscrew from rotating upon rotation of the nut.
`medication from the cartridge. The rotatable nut is disposed
`The device also includes a mechanism which indicates to
`within the housing and is threadably engaged with the drive
`stem. The dial mechanism is rotatable, axially shiftable, and
`the user that there is an insufficient dosage remaining in the
`cartridge of medication. This mechanism prevents the user 55 includes an end-of-injection axial position and a dose-setting
`axial position. The dial mechanism is rotatably engaged with
`from setting a dosage greater than that available to be
`the nut when in the dose-setting position whereby rotation of
`delivered. The insufficient dose remaining feature comprises
`the dial mechanism relative to the housing causes the nut to
`an approximately 350° helical thread on the inner cylindrical
`rotate relative to the drive stem to thereby set a dose. The
`surface of the nut and a raised key at the end of the leadscrew
`where the external thread terminates. As the nut rotates go dial mechanism is axially engaged with the nut during
`injection to thereby drive the drive stem forward. The
`about the leadscrew, the ledge formed by the termination of
`housing includes at least one rotation preventing lock ele­
`the helical thread on the nut engages the key, thereby
`ment which is engageable by a mating lock element on the
`positively preventing further rotation of the nut in that
`nut when the dial mechanism is in the end-of-injection axial
`direction and indicating the device contains an insufScient
`65 position to thereby prevent the nut from rotating.
`remaining dose.
`The present device also includes a mechanism which
`The present invention, in one form thereof, provides a
`prevents rotation of the nut when the dial mechanism is in
`medication injection pen having a distal end and a proximal
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1013. p. 8, of 17
`
`

`

`5
`6
`mechanism further includes first and second threads on an
`end. The pen comprises a housing, a cartridge, a drive stem,
`a rotatable nut, and a dial mechanism. The cartridge is
`inner circumference thereof which are adapted to ride along
`mounted within the housing and includes a piston, an exit,
`the housing helical groove and elastically deform inward
`and injectable medication between the piston and the exit.
`and outward relative to the dial. The button is telescopingly
`The drive stem is disposed within the housing in axial 5 received in the proximal end of the dial mechanism, and
`alignment with the cartridge and is adapted to axially move
`includes a distal end having a first circumferential step and
`through the cartridge for driving the piston and ejecting
`a second circumferential step. The first step has an enlarged
`medication from the cartridge. The rotatable nut is disposed
`diameter, and the second step has a larger diameter than the
`within the housing and is threadably engaged with the drive
`first step. The first step engages and biases the elastically
`stem. The dial mechanism is rotatable, axially shiftable, and JQ deformable threads outward such that the threads engage the
`includes an end-of-injection axial position and a dose-setting
`helical groove and prevent the dial mechanism from being
`axial position. The dial mechanism is rotatably engaged with
`telescopingly inserted into the housing. The second step
`the nut when in the dose-setting position whereby rotation of
`engages the dial mechanism to prevent the button from
`the dial mechanism relative to the housing causes the nut to
`being fully retracted out of the pen. The button is adapted to
`rotate relative to the drive stem to thereby set a dose. The J5 telescopingly insert into the dial to thereby move the button
`dial mechanism is axially engaged with the nut during
`first step out of engagement with the deformable threads to
`injection to thereby drive the drive stem forward. Adamping
`thereby allow the threads to deform inward and out of
`compound is disposed between the dial mechanism and the
`engagement with the helical groove. The dial mechanism is
`nut to provide relatively slow, smooth, and quiet movement
`thereby able to telescopingly insert into the housing to drive
`from the dose- setting position to the end-of-injection posi- 20 the nut, drive stem, and piston for injection of the medica­
`tion.
`tion.
`The present invention, in yet another form thereof, pro­
`The present invention, in still another form thereof, pro­
`vides a medication injection pen having a distal end and a
`vides a method of manufacturing a medication injection pen
`proximal end. The pen comprises a housing, a cartridge, a
`housing comprising the steps of disposing first and second
`drive stem, a rotatable nut, and a dial mechanism. The 25
`semi-cylindrical plastic portions having longitudinal edges
`housing includes a circular groove about an inner circum­
`around a dosage setting and injection apparatus such that the
`ference thereof. The cartridge is mounted within the housing
`portions form a cylindrical housing, and ultrasonically weld­
`and includes a piston, an exit, and injectable medication
`ing the portions together wherein the portions are vibrated at
`between the piston and the exit. The drive stem is disposed
`a frequency sufScient to melt the longitudinal edges. The
`within the housing in axial alignment with the cartridge and 30 portions are secured together when the plastic hardens,
`is adapted to axially move through the cartridge for driving
`the piston and ejecting medication from the cartridge. The
`BRIEF DESCRIPTION OF THE DRAWINGS
`rotatable nut is disposed within the housing and is thread-
`The above mentioned and other features and objects of
`ably engaged with the drive stem. The dial mechanism is
`this invention, and the manner of attaining them, will
`rotatable, axially shiftable, and includes an end-of-injection 35
`become more apparent and the invention itself will be better
`axial position and a dose-setting axial position. The dial
`understood by reference to the following description of the
`mechanism is rotatably engaged with the nut when in the
`invention taken in conjunction with the accompanying draw­
`dose-setting position whereby rotation of the dial mecha­
`ings wherein:
`nism relative to the housing causes the nut to rotate relative
`FIG. 1 is a sectional assembly view of the present
`to the drive stem to thereby set a dose. The dial mechanism 40
`invention;
`is axially engaged with the nut during injection to thereby
`drive the drive stem forward. The dial mechanism includes
`FIG. 2 is an exploded view of the embodiment shown in
`FIG. 1;
`an end-of-injection click finger which is elastically deform-
`able relative to the dial mechanism, and which snaps into the
`FIG. 3 is a perspective view of the housing first part which
`housing circular groove when an injection is complete to 45 forms one-half of the housing of the present invention;
`provide the user with an audible indication thereof.
`FIG. 4 is a sectional view of the element shown in FIG.
`The present invention, in another form thereof, provides
`3 taken along line 4—4;
`a medication injection pen having a distal end and a proxi­
`FIG. 5 is a perspective view of the housing second part
`mal end. The pen comprises a housing, a cartridge, a drive
`which forms the other half of the housing of the present
`stem, a rotatable nut, and a dial mechanism. The housing 50
`invention;
`includes a helical groove disposed on an inner circumfer­
`FIG. 6 is a plan view of the dial;
`ence thereof about its proximal end. The cartridge is
`FIG. 7 is a plan view of the embodiment shown in FIG.
`mounted within the housing and includes a piston, an exit,
`6 rotated 90°;
`and injectable medication between the piston and the exit.
`FIG. 8 is a plan view of the embodiment shown in FIG.
`The drive stem is disposed within the housing in axial 55
`6 rotated 180°;
`alignment with the cartridge and is adapted to axially move
`through the cartridge for driving the piston and ejecting
`FIG. 9 is a sectional view of the embodiment shown in
`medication from the cartridge. The rotatable nut is disposed
`FIG. 7;
`within the housing and is threadably engaged with the drive
`FIG. 10 is a perspective view of the nut;
`stem. The dial mechanism is rotatable, axially shiftable, and 60
`FIG. 11 is a sectional view of the embodiment shown in
`includes an end-of-injection axial position and a dose-setting
`FIG. 10;
`axial position. The dial mechanism is rotatably engaged with
`FIG. 12 is a plan view of the screw;
`the nut when in the dose-setting position whereby rotation of
`FIG. 13 is a sectional cutaway view of the embodiment
`the dial mechanism relative to the housing causes the nut to
`T-'T y-1
`-| ^ t
`rotate relative to the drive stem to thereby set a dose. The 65 SNOWN LN ^IIJ. LZ>
`FIG. 14 is a perspective view of the button; and
`dial mechanism is axially engaged with the nut during
`injection to thereby drive the drive stem forward. The dial
`FIG. 15 is a sectional view of the button.
`
`1
`
`US 6,221,046 B1
`
`•
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1013. p. 9, of 17
`
`

`

`US 6,221,046 B1
`
`7
`Corresponding reference characters indicate correspond­
`ing parts throughout the several views. The exemplification
`set out herein illustrates an exemplary embodiment of the
`invention and such exemplification is not to be construed as
`limiting the scope of the invention in any manner.
`
`8
`dial mechanism 34 is at a maximum at its proximal end and
`is at a minimum at its distal end. Dial mechanism 34
`comprises proximal portion 78, intermediate portion 80, and
`distal portion 82. Proximal portion 78 comprises enlarged
`5 diameter portion 84, tapered portion 86, and ring 90 extend­
`ing about the circumference of proximal portion 78. Ring 90
`DESCRIPTION OF THE PREFERRED
`also includes an enlarged "zero-dose" protrusion 88 as best
`EMBODIMENT
`shown in FIG. 7.
`Generally U-shaped grooves 91 and 93 (FIGS. 6, 8) are
`For purposes of this application, the term "proximal"shall
`designate a relative axial position toward the button end of 10 formed in intermediate portion 80 to form a flexible sections
`92 and 95, respectively. As best shown in FIG. 9, the
`the delivery pen, and the term "distal" shall designate a
`proximal ends of flexible sections 92 and 95 each include
`relative axial position toward the delivery needle end of the
`fingers 94 having ramped inner surfaces 96 adapted for
`delivery pen.
`engagement with enlarged diameter portion 54 of button 32.
`Referring to FIGS. 1 and 2, there is shown an injection
`When button 32 is depressed, enlarged diameter portion 54
`medication device 20 having the general appearance of a pen
`is also depressed and thereby pushes against ramped sur­
`or mechanical pencil. The device comprises a mechanism
`faces 96, which in turn forces fingers 94 outward and legs
`housing 22 having a first part 24 and a second part 26 (FIG.
`102 and 104 inward. Dial mechanism 34 is then able to
`2). Housing parts 24 and 26 are secured together by ultra­
`travel axially towards cartridge 40 during injection of the
`sonic welding wherein, as shown in FIG. 3 and FIG. 5, 20
`medical product as further discussed herein, shown in FIG.
`rectangular projections 27 extending from housing parts 24
`6, flexible
`section 92 further includes a click finger 97
`and 26 are inserted into V-shaped grooves 29 also provided
`extending toward the proximal end of dial mechanism 34
`in housing parts 24 and 26 and the two housing parts 24 and
`which will also be described further herein.
`26 are then vibrated at a frequency sufScient to melt pro­
`Proximal portion 78 of dial mechanism 34 further
`jections 27 where projections 27 contact V-shaped grooves ^
`includes a first U-shaped groove 100 (FIG. 6) and a second
`29. The melted plastic then hardens and housing parts 24 and
`U-shaped groove 101 (FIG. 8) which form flexible legs 102,
`26 are thereby secured together. A cap 28 is snapped onto the
`104. Referring to FIG. 9, each leg 102, 104, respectively
`distal end of mechanism housing 22. As best shown in FIG.
`includes an inwardly extending finger 106, 108, and an
`1, cap 28 includes a clip 30 which cooperates with the side
`wall of cap 28 to provide a convenient means for holding the
`outwardly extending thread 110, 112. Inwardly extending
`pen device 20 in a shirt pocket. finger
`106 includes proximal tapered surface 114, flat sur­
`face 116, and distal tapered surface 118. Likewise, finger
`Referring to FIG. 2, the other major components of
`108 includes proximal tapered surface 120, flat surface 122,
`medication device 20 include button 32, dial mechanism 34,
`and distal tapered surface 124. Outwardly extending thread
`nut 36, and a drive stem in the form of leadscrew 38.
`110 comprises proximal shoulder 130, enlarged diameter
`Cartridge 40 is inserted into distal body 42 to which is
`35 surface 132, and distal tapered surface 134. Outwardly
`attached needle assembly 44 and needle cover 46. All of the
`extending thread 112 includes shoulder 138, enlarged diam­
`components of medication device 20, except cartridge 40
`eter surface 140, and distal tapered surface 142. Leg 102 and
`and needle 44 may be made of a plastic material that is
`outwardly extending thread 110 are of lesser wid