`Harris
`
`US005226895A
`[ii] Patent Number:
`[45] Date of Patent:
`
`5,226,895
`Jul. 13, 1993
`
`604/208
`
`604/211
`604/211
`604/186
`604/208
`604/232
`604/208
`
`4,475,905 10/1984 Himmelstrup
`4,498,904 2/1985 Turner et al. .
`4,592,745 6/1986 Rex et al
`4,710,179 12/1987 Haber et al
`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
`FOREIGN PATENT DOCUMENTS
`268191 5/1988 European Pat. Off. .
`1632032 11/1977 Fed. Rep. of Germany .
`3031830 3/1982 Fed. Rep. of Germany .
`8804656.7 9/1988 Fed. Rep. of Germany .
`250467 10/1987 German Democratic Rep. .
`WO87/02895 5/1987 PCT Int'l Appl. .
`WO88/07874 10/1988 PCT Int'l Appl. .
`Primary Examiner—Michael H. Thaler
`Assistant Examiner—C. Maglione
`Attorney, Agent, or Firm—Douglas J. Taylor; Leroy
`Whitaker
`[57]
`ABSTRACT
`The present invention relates to a hypodermic syringe
`having the same general appearance as a pen which is
`specifically adapted to provide for multiple measured
`injections of materials such as insulin or human growth
`hormone.
`
`17 Claims, 3 Drawing Sheets
`
`54
`
`48
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`
`[54] MULTIPLE DOSE INJECTION PEN
`[75] Inventor: Dale C. Harris, Fairland, Ind.
`[73] Assignee: Eli Lilly and Company, Indianapolis,
`Ind.
`[21] Appl. No.: 960,314
`[22] Filed:
`Oct. 13,1992
`
`Related U.S. Application Data
`[63] Continuation of Ser. No. 361,132, Jun. 5, 1989, aban(cid:173)
`doned.
`[51] Int.Cl.5
`[52] U.S. a.
`[58] Field of Search
`
`[56]
`
`A61M 5/00
`604/208; 604/211;
`604/218
`604/192, 193, 201, 203,
`604/207-211, 218, 224, 246
`References Cited
`U.S. PATENT DOCUMENTS
`3,002,517 12/1959 Pitton
`3,232,117 2/1966 Gilmont .
`3,613,952 10/1971 Gilmont .
`3,815,785 6/1974 Gilmont
`3,884,230 5/1975 Wulff
`4,096,751 6/1978 Withers et al
`4,275,729 6/1981 Silver et al
`4,367,739 1/1983 Le Veen et al. .
`4,395,921 8/1983 Oppenlander
`4,413,760 11/1983 Paton .
`
`132/85
`
`222/46
`... 128/221
`. 73/425.6
`128/218 C
`
`73/864.18
`
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`Mylan Exhibit - 1023
`Mylan v. Sanofi
`
`
`
`U.S. Patent
`
`July 13, 1993
`
`Sheet 1 of 3
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`5,226,895
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`Mylan Exhibit - 1023
`Mylan v. Sanofi
`
`
`
`U.S. Patent
`
`July 13, 1993
`
`Sheet 2 of 3
`
`5,226,895
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`Mylan Exhibit - 1023
`Mylan v. Sanofi
`
`
`
`U.S. Patent
`
`July 13, 1993
`
`Sheet 3 of 3
`
`5,226,895
`
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`Mylan Exhibit - 1023
`Mylan v. Sanofi
`
`
`
`5,226,895
`
`1
`MULTIPLE DOSE INJECTION PEN
`
`2
`tions in order to determine the dosage delivered. Fur
`ther, most prior art devices are specifically intended for
`repeated use generally by substitution of containers
`The present application is a continuation application
`within the syringe which can contribute to the unethical
`of copending application Ser. No. 07/361,132, filed Jun. 5 use of the syringe in connection with non-prescribed
`5, 1989, now abandoned.
`substances.
`SUMMARY OF THE INVENTION
`BACKGROUND OF THE INVENTION
`In order to overcome these and other shortcomings
`The present invention relates generally to devices
`suitable for use in dispensing a measured amount of 10 of the prior art, a syringe constructed in accordance
`with the present invention includes a housing for hold
`liquid material from a container. The invention particu
`ing a container of liquid similar to that known in the
`larly relates to a hypodermic syringe having the same
`prior art. A plunger rod is received within the housing
`general appearance as a pen which is specifically
`for exerting a force on a piston closing a second end of
`adapted to provide for multiple measured injections of
`15 the container. The plunger rod has a non-cylindrical
`materials such as insulin or human growth hormone.
`cross-section with a first surface including threads and a
`Diabetics and others frequently find themselves in
`second surface which can, optionally, include a line of
`situations where the assistance of a health professional
`to administer the subcutaneous or intramuscular injec
`ratchet teeth. A collar is received within the housing
`adjacent to the container second end for permanently
`tion of measured amount of a liquid agent is generally
`not available. In such situations such persons need to 20 retaining the container of liquid within the housing. The
`collar has a non-cylindrical opening corresponding
`have a low cost syringe which does not require the
`generally to the cross-section of the plunger rod. The
`assistance of a health professional to achieve the desired
`plunger rod passes through the non-cylindrical opening
`measure of accuracy. It is often the case that such per
`and is prevented from rotating with respect to the hous-
`sons require more than one dose per day, each dose
`being of a somewhat different volume. Dispensers of 25 ing by the collar. A means on the collar engages the
`second surface of the plunger rod for restricting move
`this general type are known which have the general
`ment of the plunger rod away from the container of
`appearance of a pen or mechanical pencil. The dis
`penser is typically large enough to hold several such
`liquid.
`doses, yet it is small enough to fit conveniently in one's
`A hollow cap envelops the plunger rod end opposite
`pocket or purse. Examples of such devices are to be 30 the container of liquid. A skirt of the hollow cap ex-
`found in U.S. Pat. Nos. 4,413,760; 4,498,904; and
`tends inside the housing. The cap includes a threaded
`interior surface which movably engages the plunger rod
`4,592,745. Additional examples are shown in PCT Inter
`for calibrated adjustment relative thereto. The cali
`national Publications WO 87/02895 and WO 88/07874.
`In devices of this class, a container of the liquid is
`brated adjustment permits one to both increase and
`provided having a closed first end adapted to be pene- 35 decrease the amount of liquid sought to be injected from
`the pen. A stop is provided within the housing and a
`trated by a needle assembly so as to permit the liquid in
`the container to pass out the closed first end for subcuta
`distal facing surface is provided on the hollow cap for
`neous or intramuscular injection. The second end of the
`contacting the stop upon linear movement of the cap
`container is generally closed by a piston. To prevent
`and plunger rod as a unit toward the container to dis-
`tampering or reuse of the liquid container, the piston is 40 pense liquid therefrom,
`The apparatus as a whole is constructed from inex
`generally designed such that a pushing force can be
`applied to the piston to reduce the liquid-holding vol
`pensive materials and is adapted for machine assembly
`ume of the container, but no feature is presented which
`which contributes directly to a very low manufacturing
`would be suitable for pulling on the piston so as to
`cost thereby permitting the apparatus as a whole to be
`enlarge the liquid-holding volume of the container.
`45 disposable. As indicated previously, the adjustment of
`An elongated member in the nature of a plunger rod
`the dose can be increased and decreased thereby dimin
`is received within the housing for exerting a force on
`ishing any waste of the medicating liquid. The dose
`indication feature is simply and directly read thereby
`the piston closing the second end of the container. A
`providing for a more accurate and cost effective use of
`means is provided for measuring the distance which the
`plunger rod travels to determine the decrease in volume 50 the medicating liquid dispensed from the apparatus,
`Additional features and advantages will become appar
`of the liquid container which causes the dispensing of
`ent to those skilled in the art from the following detailed
`the liquid within the container. It has generally been
`recognized that the dispenser should have some feature
`discussion of preferred embodiments exemplifying the
`best mode of carrying out the invention as presently
`which would allow the rod to only travel in a single
`direction toward the piston thereby preventing any 55 perceived. The detailed description particularly refers
`action on the part of the rod which might permit an
`to the accompanying figures,
`enhancement of the volume of the liquid container. A
`BRIEF DESCRIPTION OF DRAWINGS
`safety cover is generally provided over a needle assem
`FIG. 1 is an exploded perspective view of one em-
`bly attached to the closed end of the container.
`While the prior art pen-style syringes have met with 60 bodiment of a syringe in accordance with the present
`some success, certain shortcomings have also been ob
`invention.
`FIG. 2 is a sectional detail view of the syringe shown
`served. In some prior art pens, the adjustment of the
`in FIG. 1 showing the dosage adjustment features.
`dose to be injected, once made, cannot be accurately
`FIG. 3 is an exploded perspective view of an altema-
`diminished to a smaller value. This results in an unnec-
`essary waste of the medicating liquid within the syringe. 65 tive embodiment for a portion of the hollow cap includ-
`In some prior art pens, the indication of dose is difficult
`ing a maximum dosage restriction feature,
`FIG. 4 is an elevation view of the alternative embodi-
`to read. Prior art pens have sometimes required the
`patient to read two scales and/or to do some computa-
`ment shown in FIG. 3 partially assembled.
`
`Mylan Exhibit - 1023
`Mylan v. Sanofi
`
`
`
`5,226,895
`4
`3
`The prongs 71 on the inner surfaces 70 of collar 28
`FIGS. 5-9 are elevation views partially broken away
`of the embodiment shown in FIG. 4 in five different
`permit movement of the plunger rod 56 toward the
`distal end of the syringe 10 so as to cause the piston 36
`positions to illustrate the dose restriction features of the
`to move within container 14 so as to diminish the vol-
`invention.
`5 ume of the container. Alternatively, the second surface
`DESCRIPTION OF THE PREFERRED
`64 can include a line of ratchet teeth 66 as shown in
`EMBODIMENTS
`FIG. 2. The ratchet teeth 66 can interact with the inner
`A syringe 10 in accordance with the present inven-
`surfaces 70 of collar 28 even in the absence of prongs to
`tion is shown in FIGS. 1 and 2 to include a housing 12
`restrict rearward movement of the plunger rod 56.
`which is adapted to receive a container 14 of liquid 10 A hollow two-piece cap 72 is provided which envel-
`within a distal region 15 situated between the distal end
`opes substantially all of plunger rod 56 including proxi-
`18 and a first shoulder 17. A proximal region 13 be-
`mal end 50. The cap 72 includes a distal portion 74 and
`tween the first shoulder 17 and proximal end 16 is
`a proximal portion 86 which can be manufactured sepa-
`rately for simplicity. The distal portion 74 comprises a
`adapted to receive the adjustment apparatus hereinafter
`described. The proximal region 13 includes a ribbed 15 generaiiy cylindrical tube 76 having a threaded inner
`portion 19 which aids in the calibration and delivery of
`surface 78 at a distal end 80 thereof. The proximal por
`an accurate dose from the syringe. The distal end 18 of
`tion 86 is of slightly greater outside diameter than distal
`the housing 12 is adapted to receive a needle assembly
`portion 74. A proximal end 82 of distal portion 74 is
`20 including a double-ended needle 22 having a distal
`fixed to a distal end 84 of the proximal portion 86 of cap
`end 24 which is adapted to permit subcutaneous or 20
`72 thereby forming a perimeteral distal end facing sur
`intramuscular injection and a proximal end 23 adapted
`face. A proximal end 88 of the proximal portion 86
`to penetrate the rubber tip cover 26 of container 14. The
`protrudes from housing 12 at all times and can include
`container 14 is secured within the housing 12 by collar
`ribs or serrations 90 adapted to permit easy adjustment
`28 which has an outer diameter providing an interfer
`of the volume to be injected using the syringe 10. The
`ence fit with the inside wall of the proximal portion 13 25
`cap 72 includes indicia 92 providing a visual indication
`of housing 12 and forward face 30 intended to abut the
`of the measured amount of liquid to be injected and
`proximal end 32 of container 14 adjacent first shoulder
`includes a radially projecting tang 94 which interacts
`17. The container 14 is shown to generally comprise a
`with a grooved interior 19 of housing 12. The tang 94
`cylindrical envelope 34 including a piston 36 initially
`functions to provide an audible and tactile indication of
`positioned near the proximal end 32 of the container 14 30
`the amount or degree of rotational movement of cap 72
`but movable with respect to the cylindrical wall 34 so as
`with respect to housing 12. The tang 94 also aids linear
`to define a variable liquid-containing volume for the
`movement of cap 72 with respect to housing 12 under
`container 14.
`the application of a force normal to the proximal end 98
`After the container 14 is situated within the housing
`12 and retained in position by collar 28, the needle as- 35 0' caP
`.
`. .
`. .
`sembly 20 can be engaged on the distal end 18 of hous-
`operation, one desiring to inject a measured
`ing 12 by an appropriate securing means such as threads
`amount of liquid would first grasp the housing 12 in one
`38 on an inner surface of the needle assembly 20 engag-
`hand and the ribbed portion 90 of cap 72 in the other,
`ing threads 40 on an outer distal surface of housing 12.
`One would then rotate cap 72 in a counter-clockwise
`Upon full engagement of the needle assembly 20 to the 40 direction causing the threads 78 of cap 72 to travel
`housing 12, a proximal end 23 of needle 22 penetrates
`along the threaded portion 62 of rod 56. This rotation
`the rubber portion 26 of the end cap 42 of container 14
`would not cause displacement of the rod 56 with respect
`t0 'he housing 12, but would back the distal end 84 of
`thereby providing a pathway for liquid within the con-
`tainer 14 to be dispensed through needle 22.
`the proximal cap portion 86 away from stop shoulder 48
`A safety shield 44 including a sheath portion 46 and 45 on the
`of housing 12. The counter-clockwise
`rotation of the cap 72 would also expose an increasing
`an engagement portion 48 is frictionally engaged on the
`amount of indicia 92 above the proximal end 16 of the
`needle assembly 20 to safely shield the needle from
`improper use. A covering element 52 including a clip 54
`housing 12.
`is used to enclose the distal end of the housing 12, nee
`When used in connection with the dispensing of insu-
`dle assembly 20, and safety shield 44. The clip 54 coop- 50 1m, the indicia 92 is preferably denominated in intema-
`erates with the sidewall of housing 12 to provide a
`tional units. Other direct calibration scales can be used
`with other medications so that no computations are
`convenient means for holding the syringe 10 in a
`necessary to specify the desired dosage to be delivered.
`pocket.
`The dose scale provided by the indicia 92 is read di-
`The syringe also includes a plunger rod 56 having a
`distal end 58 for contacting piston 36 of container 14. 55 rectly at the end of the proximal end 16 of the housing
`12. The dose corresponds to the number corresponding
`The plunger rod 56 has a noncylindrical cross section
`to the last exposed step in the stepped line 93. In order
`with a first surface 60 of larger radial dimension which
`that the indicia 92 can be calibrated in international
`includes threads 62, and a second surface 64 of smaller
`radial dimension. The plunger rod 56 is received within
`units or equivalent direct measures of the medication in
`the non-cylindrical opening 68 of collar 28. The inter- 60 the container 14, the solutions or suspensions contained
`in the container 14 are preferably concentrated or di
`ference relationship between the noncylindrical open
`ing 68 of collar 28 and the noncylindrical cross section
`luted to optimize the potency of the medication so as to
`of plunger rod 56 prevents rotation of the plunger rod
`produce the desired physiological response in coordina
`56 within the housing 12.
`tion with the scale adopted for in indicia 92. In the event
`An inner surface 70 of collar 28 can include prongs 71 65 that one would turn the cap 72 too far, it can also be
`as shown in FIG. 1 which engage and dig into surface
`rotated clockwise to diminish the dosage to be deliv
`64 of the plunger rod 56 to restrict movement of the
`ered without effecting any change in position of the rod
`56 relative to the housing 12.
`plunger rod toward the proximal end 16 of housing 12.
`
`Mylan Exhibit - 1023
`Mylan v. Sanofi
`
`
`
`5,226,895
`
`5
`6
`When the cap 72 has been positioned to the desired
`FIG. 5 to- the position shown in FIG. 6. This rotation
`dosage as measured by the indicia 92, the safety shield
`has the effect of causing the distal facing surface 84 to
`44 and cover 52 are removed, and the syringe 10 is
`move rearward through a distance D. The rotating
`positioned for injection. A pressure is applied to end 98
`motion of the cap causes tang 94 to traverse linear mark-
`of cap 72 causing it to move linearly toward the distal 5 ings 96 thereby giving an audible and tactile sensation of
`end 18 of housing 12 until a shoulder defined by a radi
`the rotation which can be correlated with the number of
`ally exposed portion of distal end 84 contacts stop 48.
`units of the particular medicament being dispensed.
`The movement of the cap 72 causes an identical move
`This rearward motion also exposes a greater portion of
`ment of plunger rod 56 past collar 28, and movement of
`the indicia 92 which can include numbers also indica-
`piston 36 within container 14 so as to dispense the liquid 10 live of the dosage being prepared for delivery. As previ-
`therefrom. The needle 22 can then be withdrawn and
`ously indicated with respect to the embodiment shown
`the safety shield 44 and cover 52 replaced.
`in FIGS. 1 and 2, if cap 72 has been rotated too far, it
`FIG. 3 is a perspective view showing a modified
`can be rotated in the opposite direction to diminish the
`distal portion 100 of cap 72 as well as a follower 104
`required dose.
`which is adjustable with respect to the threaded outer 15
`A special feature present in the embodiments shown
`surface 106 of the distal cap portion 100 and a barrier
`in FIGS. 3 through 9 which is not present in the em
`element 108 which is secured within an upper portion of
`bodiment shown in FIGS. 1 and 2 is the presence of
`housing 12. The distal end 110 of the distal portion 100
`follower 104 which can be adjusted to any position
`has a diameter substantially equivalent to that of distal
`along threads 106. The principle function of follower
`portion 74 and has internal threads 112 identical with 20 104 is to set a maximum allowable dose where the sy-
`threads 78 of distal portion 74.
`ringe is going to be used by persons who may have
`During the assembly from the relative position shown
`difficulty remembering the proper dosage, or may have
`in FIG. 4, the follower 104 is threaded on threads 106 of
`some other physical disability which does not permit
`cap distal portion 100. The barrier element 108 is then
`them to appreciate fully the meaning of the indicia 92.
`slipped over the distal cap portion 100, and the plunger 25 In such a circumstance, the cap 72 can first be rotated to
`rod 56 is inserted within the distal portion 100 suffi
`the desired maximum measured value illustrated as an
`ciently far to permit engagement between the plunger
`arbitrary position in FIG. 6. Next, the follower 104 is
`rod 56 and the collar 28 when the apparatus is fully
`rotated through distance X from the position shown in
`assembled. The distal end 84 of the proximal portion of
`FIG. 6 to the position shown in FIG. 7. In this position,
`the cap 86 is then joined to the proximal end 114 of 30 the upper edge 124 of follower 104 abuts distall edge
`distal portion 100. The two cap portions 86 and 100 can
`120 of barrier element 108. Preferably the engagement
`be bonded by a conventional means such as ultrasonic
`between follower 104 and threads 106 is sufficiently
`welding or solvents or the like. The assembly is then
`tight such that follower 104 is moved only with some
`pushed inside housing 12 until barrier element 108 is
`difficulty, or at least, the follower 104 is not likely to
`situated at the location 116 shown in phantom. The 35 move merely under the influence of vibration or the
`barrier element 108 is then fixed to housing 12 again
`like.
`using solvents, ultrasonic welding, or other conven
`With the follower 104 set in the position shown in
`tional techniques. It will be noted that housing 12 now
`FIG. 7, the cap 72 can be rotated back to its original
`includes a side opening 118 which was not present in
`position. This rotation back to the starting position, or
`FIG. 2, which side opening provides access to follower 40 zero, will not cause any movement of the plunger rod
`104 so as to permit adjustment of the follower 104 along
`56 with respect to the collar 28 and hence no dispensing
`threads 106.
`of liquid will take place. Alternatively, a force can be
`The operation of the embodiment shown in FIGS. 3
`applied to the proximal end 98, as shown by arrow F.
`and 4 can best be understood by considering FIGS. 5
`thereby moving the cap 72 and plunger rod 56 from the
`through 9. FIG. 5 illustrates a syringe 10 in accordance 45 position shown in FIG. 7 until edge 84 once again
`with the present invention in its initial assembled posi
`contacts edge 122 of barrier element 108 thereby assum
`tion. The distal end 58 of the plunger rod 56 is shown
`ing the position shown in FIG. 8. It will be noted that
`projecting slightly beyond collar 28. While the end 58
`with the force F applied to proximal end 98, the cap 72
`would normally be seated against a rear surface of a
`and plunger rod 56 have both moved linearly through a
`piston 36 as shown in FIG. 2, the container of liquid 14 50 distance L which is identical to the distance D shown in
`and piston 36 have been omitted for the sake of clarity
`FIG. 6. The motion of the plunger rod 56 causes a
`in illustrating the motion of plunger rod 56. It will be
`forward motion of plunger 36 as shown in FIG. 2 to
`appreciated that the position of the plunger rod shown
`dispense the liquid within container 14 as previously
`in FIG. 5 is substantially identical with that shown in
`discussed.
`FIG. 2, that is, the plunger rod extends within cap 72 55
`The syringe 10 may then be stored in the position
`throughout substantially the whole length of the cap.
`shown in FIG. 8 until it is next needed for use. The
`Comparing FIGS. 5 to FIG. 9, it will be noted that
`edges 70 of collar 28 prevent any relative movement
`follower 104 has been threaded on threaded portion 106
`between the housing 12 and plunger rod 56 merely due
`until contacting the distal end 110 of the distal cap por
`to vibration or shock. When it is necessary to again use
`tion 100. Barrier element 108 is fixed within housing 12 60 the syringe one again rotates cap 72 in the direction R
`so that a distal edge 120 of barrier element 108 is sub
`from the position shown in FIG. 8 toward the position
`stantially flush with the proximal edge of window 118.
`shown in FIG. 9. The follower 104 now limits the mo
`The proximal edge 122 of barrier element 108 forms a
`tion which can take place to something significantly less
`stop against which the distal end 84 of the proximal
`than that which could have been achieved before the
`portion 86 of cap 72 abuts.
`65 follower 104 was moved from the position shown in
`In order to dispense a measured amount of liquid, the
`FIG. 6. The rotating motion of cap 72 relative to hous
`serrated portion 88 of cap 72 is grasped and rotated in
`ing 12 does not cause any relative motion between hous
`the direction of arrow cap R from the position shown in
`ing 12 and plunger rod 56. It will be appreciated that
`
`Mylan Exhibit - 1023
`Mylan v. Sanofi
`
`
`
`5,226,895
`8
`7
`while follower 104, set in the position shown in FIGS.
`opposite sides of the plunger rod each engaging a sur
`7 through 9, limits the maximum dose which might be
`face on the plunger rod so as to prevent movement of
`delivered^ a smaller dose could be delivered if the cap
`the plunger rod toward the housing proximal end.
`72 were not rotated to the position where follower 104
`8. The improvement of claim 1 wherein the third
`abutts barrier element 108.
`5 means comprises a hollow cap enveloping the plunger
`Although the invention has been described in detail
`rod end opposite the container and extending outward
`with reference to the illustrated preferred embodiments,
`from the housing proximal end, the cap having a
`variations and modifications exist within the scope and
`threaded interior surface rotatably engaging the first
`threaded surface of the plunger rod for calibrated axial
`spirit of the invention as described and as defined in the
`10 adjustment relative thereto without causing rotation of
`following claims.
`What is claimed is:
`the housing.
`1. An improved means for adjustment of the dosage
`9. The improvement of claim 8 wherein the hollow
`cap further comprises a flexible member projecting
`of liquid to be injected from a syringe having a housing
`outward from the cap and the housing further com-
`for receiving a container of liquid, the container of
`liquid having a closed first end and a piston closing a 15 prises a grooved interior surface, said flexible member
`second end of the container, the housing having a proxi-
`engaging said grooved interior surface of the housing
`mal end and a distal end, the distal end being adapted to
`such that the calibrated relative adjustment causes sensi-
`receive an injection needle assembly for permitting
`ble movement of the flexible member,
`10. The improvement of claim 1 wherein the third
`liquid to pass out of the container first end, a plunger
`rod, having a noncylindrical cross-section with a first 20 means comprises a hollow cap enveloping the plunger
`rod end opposite the container and extending outward
`surface, including threads, and a second surface, re(cid:173)
`from the housing proximal end, the cap rotatably engag
`ceived within the housing for exerting a force on the
`ing the plunger rod and having a distal end facing sur
`piston closing the container second end, the improve(cid:173)
`face for contacting a stop fixed with respect to the hous-
`ment comprising:
`first means received within the housing adjacent the 25 ing upon movement of the cap and plunger rod toward
`container second end for preventing rotation of the
`the housing distal end.
`11. The improvement of claim 10 wherein the distal
`plunger rod in relation to the housing,
`end facing surface comprises the distal end of the cap,
`second means engaging a second surface of the
`and the stop comprises a land within the housing situ-
`plunger rod for restricting movement of the
`30 ated to contact the distal end of the cap so that a proxi
`plunger rod toward the housing proximal end,
`mal portion of the cap remains projecting from the
`third means, used to adjust the dosage of liquid to be
`proximal end of the housing.
`injected from the syringe, which means rotatably
`12. A syringe having means for adjustment of the
`engages a first surface of the plunger rod for cali(cid:173)
`dosage of liquid to be injected comprising:
`brated axial movement with respect to the plunger
`a housing for receiving a container of liquid, the con
`rod and housing toward the housing proximal end 35
`tainer of liquid having a closed first end an da pis
`without causing rotation of the housing, and
`ton closing a second end of the container, the hous
`fourth means fixed with respect to the housing for
`ing having a proximal end and a distal end, the
`stopping any movement of the third means toward
`distal end being adapted to receive a needle assem
`the housing distal end at a fixed position relative to
`bly for permitting liquid to pass out of the closed
`the housing.
`40
`2. The improvement of claim 1 wherein the first
`first end of the container,
`a plunger rod received within the housing for exert
`means comprises a collar received within the housing
`ing a force on the piston closing the second end of
`adjacent the container second end, the collar having a
`the container, the plunger rod having a non-cylin
`non-cylindrical opening corresponding generally to the
`drical cross section, a first
`surface including
`cross-section of the plunger rod for preventing rotation 45
`threads, and a second surface,
`of the plunger rod with respect to the housing.
`3. The improvement of claim 2 wherein the collar
`a collar received within the housing adjacent the
`comprises a radial outside surface frictionally engaging
`container second end, the collar having a non-
`an inside surface of the housing, and a distal end surface
`cylindrical opening corresponding generally to the
`contacting the container of liquid for maintaining the 50
`cross-section of the plunger rod for preventing
`container in fixed position with respect to the housing.
`rotation of the plunger rod with respect to the
`4. The improvement of claim 2 wherein the second
`housing and engaging means engaging the plunger
`means comprises engaging means included within the
`rod second surface for restricting movement of the
`collar non-cylindrical opening and engaging a second
`plunger rod toward the housing proximal end, and
`surface on the plunger rod for restricting movement of 55
`a hollow cap, used to adjust the dosage of liquid to be
`the plunger rod toward the housing proximal end.
`injected from the syringe, enveloping the plunger
`5. The improvement of claim 4 wherein the engaging
`rod end opposite the container and extending out
`means comprises a pair of opposed edges situated on
`ward from the housing proximal end, the cap hav
`opposite sides of the plunger rod each engaging a sec
`ing a threaded interior surface rotatably engaging
`ond surface on the plunger rod so as to prevent move- 60
`the plunger rod first surface portion for calibrated
`ment of the plunger rod toward the housing proximal
`axial adjustment relative thereto, without causing
`end.
`rotation of the housing, and a distal end facing
`6. The improvement of claim 1 wherein the second
`surface for contacting a stop fixed with respect to
`means comprises engaging means engaging a second
`the housing upon movement of the cap and plunger
`surface on the plunger rod for restricting movement of 65
`rod toward the housing distal end.
`the plunger rod toward the housing proximal end.
`13. The syringe of claim 12 wherein the collar com
`7. The improvement of claim 6 wherein the engaging
`prises a radial outside surface frictionally engaging an
`means comprises a pair of opposed edges situated on
`inside surface of the housing, and a distal end surface
`
`Mylan Exhibit - 1023
`Mylan v. Sanofi
`
`
`
`9
`contacting the container of liquid for maintaining the
`container in fixed position with respect to the housing.
`14. The syringe of claim 12 wherein the engaging
`means comprises a pair of oppos