(12) United States Patent
`Giambattista et al.
`
`US006932794B2
`US 6,932,794 B2
`Aug. 23,2005
`
`(io) Patent No.:
`(45) Date of Patent:
`
`(54) MEDICATION DELIVERY PEN
`
`(75)
`
`Inventors: Lucio Giambattista, East Hanover, NJ
`(US); Antonio Bendek, Vernon, NJ
`(US)
`
`(73) Assignee: Becton, Dickinson and Company,
`Franklin Lakes, NJ (US)
`
`( * ) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 236 days.
`
`(65)
`
`(21) Appl. No.: 10/406,302
`Apr. 3, 2003
`(22) Filed:
`Prior Publication Data
`US 2004/0199117 Al Oct. 7, 2004
`(51) Int. CI.7
`(52) U.S. CI
`(58) Field of Search
`
`A61M 5/00
`604/207; 604/208; 604/211
`604/207, 208,
`604/211, 209, 210, 232, 218, 224
`
`(56)
`
`References Cited
`U.S. PATENT DOCUMENTS
`
`4,936,833 A
`5,304,152 A
`5,308,340 A
`
`6/1990 Sams
`4/1994 Sams
`5/1994 Harris
`
`a
`,54 /H I
`
`AT 10
`
`50
`
`5,383,865 A
`5,514,097 A
`5,584,815 A
`6,248,095 B1
`
`1/1995 Michel
`5/1996 Knauer
`12/1996 Pawelka et al.
`6/2001 Giambattista et al.
`
`Primary Examiner—Sharon Kennedy
`(74) Attorney, Agent, or Firm—David M. Fortunato
`ABSTRACT
`
`(57)
`
`A medication delivery pen is provided including a leadscrew
`having a plurality of threads; a driver coaxially disposed
`about at least a portion of the leadscrew; a dosing ring
`non-rotatably disposed on the driver, the dosing ring also
`being slidable along the driver; and, a dose knob coaxially
`disposed about the dosing ring. At least one tooth is formed
`on one of the dose knob and the dosing ring, and at least one
`groove is formed on the other of the dose knob and the
`dosing ring, with the groove being formed to receive the
`tooth. The dosing ring is selectively movable relative to the
`dose knob from a first position where the tooth and the
`groove are spaced apart to a second position where the tooth
`is received within the groove, the dosing ring being rotatable
`with the dose knob with the dosing ring being in the second
`position. Incorrect dosage settings of the inventive pen may
`be easily corrected by a user via a novel dial-back feature
`that enables the user to reset the dose amount without
`expelling medication and without having to dial the dose
`knob to an extended, reset position.
`
`18 Claims, 9 Drawing Sheets
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`Mylan Exhibit - 1016
`Mylan v. Sanofi
`
`

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`U.S. Patent
`
`Aug. 23,2005
`
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`US 6,932,794 B2
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`Mylan Exhibit - 1016
`Mylan v. Sanofi
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`Mylan v. Sanofi
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`Aug. 23,2005
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`Aug. 23,2005
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`Aug. 23,2005
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`Aug. 23,2005
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`Aug. 23,2005
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`Mylan v. Sanofi
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`U.S. Patent
`
`Aug. 23,2005
`
`Sheet 9 of 9
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`US 6,932,794 B2
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`Mylan Exhibit - 1016
`Mylan v. Sanofi
`
`

`

`US 6,932,794 B2
`
`1
`MEDICATION DELIVERY PEN
`
`2
`FIG. 2 is an exploded view of a medication delivery pen
`constructed in accordance with the subject invention;
`FIG. 3 is a cross-sectional view of a body useable with the
`BACKGROUND OF THE INVENTION
`subject invention;
`This invention relates to medication delivery instruments 5
`FIG. 4 is a cross-sectional view taken along line 4—4 of
`and, more particularly, to medication delivery pens, such as
`FIG. 3;
`those used in administering insulin.
`FIG. 5 is a cross-sectional view of a driver useable with
`Various medication delivery pen designs are known in the
`the subject invention;
`prior art, including that shown in U.S. Pat. No. 6,248,095,
`FIG. 6 is an enlarged perspective view of a proximal end
`which issued on Jun. 19, 2001, to one of the inventors herein 10
`of the driver shown in FIG. 5;
`and the assignee hereto. To administer a dose of medication,
`FIG. 7 is a cross-section of a medication delivery pen
`such as insulin, using the pen of U.S. Pat. No. 6,248,095, and
`constructed in accordance with the subject invention;
`as is commonly done with other medication delivery pen
`FIG. 8 is a cross-sectional view taken along line 8—8 of
`designs, a dose knob is manually rotated until a desired dose
`FIG. 7;
`amount is set. Thereafter, a needle cannula is inserted into a 15
`FIG. 9 is a cross-sectional view taken along line 9—9 of
`patient and a button located at the end of the dose knob is
`FIG. 7;
`depressed resulting in the administration of the desired dose.
`U.S. Pat. No. 6,248,095 is incorporated herein by reference
`FIG. 10 is a cross-sectional view taken along line 10—10
`of FIG. 7; and,
`in its entirety.
`FIGS. 11 and 12 are partial cross-sectional views
`Prior art medication delivery pens, however, suffer from 20
`showing, respectively, the medication delivery pen in a rest
`the drawback that if the dose knob is adjusted beyond a
`state and in an initial dosing state.
`desired dose (i.e., an error in dosing is made), a waste of time
`or medication results in correcting to the desired amount. In
`DETAILED DESCRIPTION OF THE
`one manner of correcting for the mistake, the dose knob can
`INVENTION
`be "dialed back" to the lower dose amount and there set. 25
`With reference to the Figures, particularly FIG. 1, a
`However, such "dialing back" will result in the wasteful
`medication delivery pen is shown and generally designated
`expulsion of medicine commensurate to the amount cor­
`with the reference numeral 10. The medication delivery pen
`rected. For example, if the pen is "dialed back" from a 300
`10 may be used for the administration of various
`/AX dosage to a 250 /AX dosage, 50 /A will be wastefully
`30 medications, including insulin; the medication not compris­
`expelled. Alternatively, some pens, such as that disclosed in
`ing a part of the present invention. In addition, the term
`U.S. Pat. No. 6,248,095, provide for a reset mechanism
`"medication" is used in an illustrative and non-limiting
`which allows for the dose knob to be disengaged and
`manner to refer to any substance that may be injected into a
`returned to a zero position without "dialing back". Such
`patient for any purpose. The medication delivery pen 10 of
`reset typically involves "dialing out" the dose knob to its
`35 the present invention may also be reusable or disposable.
`fullest extent where it is disengaged and then returning the
`With reference to FIG. 2, the medication delivery pen 10
`dose knob back to a start position. Although it is possible to
`generally includes a cap 12, a cartridge holder 14, a spinner
`reset the pen, additional time and effort is required to do so.
`16, a body 18, a dose knob 20, a dosing ring 22, a driver 24,
`SUMMARY OF THE INVENTION
`a leadscrew 26, a dosing ring adaptor 28, and a thumb button
`The present invention provides a medication delivery pen 40 30. The cartridge holder 14 is formed to accommodate a
`drug cartridge 32, which may be of any conventional design.
`which overcomes the deficiencies of the prior art. The
`By way of non-limiting example, the drug cartridge 32 may
`medication delivery pen includes a leadscrew having a
`include an elastomeric septum 34 at a proximal end thereof
`plurality of threads; a driver coaxially disposed about at least
`and an open distal end 36 which exposes a slidable plunger
`a portion of the leadscrew; a dosing ring non-rotatably
`disposed on the driver, the dosing ring also being slidable 45 38 (FIG. 7). Drug medication is contained within the drug
`cartridge 32 between the septum 34 and the plunger 38. As
`along the driver; and, a dose knob coaxially disposed about
`will be described in more detail below, the spinner 16 is
`the dosing ring. At least one tooth is formed on one of the
`configured to engage the plunger 38 and force forward
`dose knob and the dosing ring, and at least one groove is
`movement thereof in expelling drug from the drug cartridge
`formed on the other of the dose knob and the dosing ring,
`with the groove being formed to receive the tooth. The 50 32. A needle (not shown) is required to administer drug from
`the medication delivery pen 10. The needle may be a
`dosing ring is selectively movable relative to the dose knob
`double-ended cannula which is threadedly mounted onto
`from a first position where the tooth and the groove are
`threads 40 of the cartridge holder 14. One end of the cannula
`spaced apart to a second position where the tooth is received
`is exposed for insertion into a patient, while the second end
`within the groove, the dosing ring and the dose knob being
`55 of the cannula is disposed to pierce the septum 34 of the drug
`rotatable with the dosing ring in the second position.
`cartridge 32. After administration of the dose, the needle is
`With the subject invention, the dose knob can be dialed
`removed, with the septum 34 self-sealing. The cap 12 is
`freely in both directions, without causing medicine to be
`formed to releasably mount onto the cartridge holder 14,
`administered, particularly upon "dialing back". In addition,
`such as with a snap fit, to limit contamination of the septum
`resetting of the dose knob is altogether avoided in allowing
`60 34 and the surrounding portions of the cartridge holder 14.
`for a downward-correction in dosage amount.
`A resilient holding arm 13 may extend from the cap 12 to
`These and other features of the subject invention will be
`provide holding force for the pen 10 in a patient's pocket.
`better understood through a study of the following detailed
`One or more windows 35 may also be provided in the
`description and accompanying drawings.
`cartridge holder 14 to give a visual indication of the drug
`DESCRIPTION OF THE DRAWINGS
`65 level in the drug cartridge 32.
`With reference to FIG. 3, the body 18 is generally
`FIG. 1 is a side-elevational view of a medication delivery
`pen constructed in accordance with the subject invention;
`cylindrical, having threads or detents 42 onto which the
`
`Mylan Exhibit - 1016
`Mylan v. Sanofi
`
`

`

`US 6,932,794 B2
`
`4
`3
`cartridge holder 14 is formed to be mounted. A bulkhead 44
`The dose knob 20 preferably includes one or more ratchet
`arms 96 formed to be biased inwardly. With reference to
`extends across the interior of the body 18 through which an
`FIG. 8, with the dose knob 20 being coaxially disposed
`aperture 46 is formed. The aperture 46 is defined to allow the
`about the dosing ring 22, the ratchet arms 96 are aligned with
`passage therethrough of the leadscrew 26, yet the aperture
`the longitudinal ribs 80 so that rotation of the dose knob 20
`46 is shaped (e.g., being rectangular) to prevent rotation of 5
`the leadscrew 26 therewithin. The body 18 also includes an
`relative to the dosing ring 22 results in the ratchet arms 96
`interiorly-supported cylindrical wall 48 which defines a
`acting against the ribs 80 in a ratcheting manner giving a
`channel 50 therethrough. A transverse recess 53 is defined
`user an audible signal of such rotation. In contrast to the
`between the aperture 46 and the channel 50 which is
`prior art, the dose knob 20 can freely rotate in both directions
`bounded by wall 55, that may be continuous or discontinu­
`10 relative to the dosing ring 22 with the ratchet arms 96 acting
`ous. In addition, a dose setting thread 54, as known in the
`against the ribs 80 during both rotational directions of the
`prior art, is formed on the interior of the body 18, along with
`dose knob 20.
`a window 56 for dosage selection. A pointer 58 defined on
`The dose knob 20 is also formed with one or more lips 98
`the body 18 may extend into the window 56 to clearly point
`(FIG. 2) which are formed in proximity to the proximal end
`out a selected dosage level.
`15 90 and from which extend one or more teeth 100. The teeth
`With reference to FIG. 5, the driver 24 includes proximal
`100 are formed and positioned to be received in the grooves
`and distal ends 60 and 62, respectively, with a snap ring 64
`76 formed on the dose knob 20 and preferably face axially
`being formed at the proximal end 60. The snap ring 64 is
`with regard to the longitudinal axis of the dose knob 20.
`formed to pass through the channel 50 of the body 18 and
`With reference to FIG. 10, the teeth 100 are much less in
`lock onto the wall 48 in the recess 53 (FIG. 7). With the snap 20
`number than the grooves 76 to facilitate alignment.
`ring connection, the driver 24 is fixed axially relative to the
`The dosing ring 22 is mounted onto the dosing ring
`body 18, yet is able to rotate relative thereto. Internal threads
`adaptor 28 with the snap ring 82 of the dosing ring 22
`68 are also provided to threadedly engage threads 70 of the
`snapping into locking channel 102 defined in the dosing ring
`leadscrew 26. Additionally, as shown in FIG. 2, ledge 72 and
`one or more longitudinal keyways 74 are defined on the 2, adaPtor 28- ^ such> the dosing ring 22 and the dosing ring
`adaptor 28 are movable in concert with each other. In an
`exterior surface of the driver 24.
`alternative embodiment, the dosing ring adaptor 28 and the
`Preferably, as more clearly shown in FIG. 4, a plurality of
`dosing ring 22 may be formed unitarily.
`ratchet teeth 52 extend from the cylindrical wall 48. In
`The leadscrew 26 may be of any conventional type and is
`addition, one or more ratchet fingers 66 are formed on the
`proximal end 60 of the driver 24 and are located in proximity 30 formed with a threaded end 103. The spinner 16 includes a
`threaded aperture 105 formed to threadedly engage the
`to the snap ring 64. The ratchet fingers 66 are positioned
`threaded end 103 in mounting the spinner 16 onto the
`within the channel 50 when the driver 24 is locked in the
`leadscrew 26. Alternatively, the thumb button 30 is of any
`recess 53 (FIG. 7). Preferably, the ratchet teeth 52 and the
`conventional design and formed to snap onto the dose ring
`ratchet fingers 66 cooperate to allow the driver 24 to rotate
`in only one direction relative to the body 18. The ratchet 35 adaptor 28. The thumb button 30 may be unitarily formed
`with the dose ring adaptor 28.
`teeth 52 and the ratchet fingers 66 provide a measure of
`With reference to FIGS. 7, 11 and 12, the dosing ring
`protection against unwanted rearward movement of the
`adaptor 28 includes an inwardly extending shoulder 104.
`leadscrew 26, as described more fully below.
`With the pen 10 being fully assembled, a biasing means 106,
`Dosing ring 22 is formed with one or more grooves 76 at
`a proximal end 78 thereof; a plurality of longitudinal ribs 80; 40 such as a coil sPrin& is preferably disposed between the
`ledge 72 of the driver 24 and the shoulder 104 of the dosing
`a snap ring 82 in proximity to a distal end 84 thereof; and,
`inwardly extending splines 86 formed and located to be
`ring adaptor 28. Consequently, the dosing ring adaptor 28 is
`disposed in the keyways 74 of the driver 24. As best shown
`urged distally within the pen 10, along with the dosing ring
`in FIG. 9, in assembling the pen 10, the dosing ring 22 is
`22- Stop member 108 may be provided on the dosing ring
`mounted onto the driver 24 with the splines 86 extending 45 adaPtor 28 formed to abut against inwardly-extending ring
`110 defined on the dose knob 20 under force of the biasing
`into the keyways 74. As a result, the dosing ring 22 cannot
`means 106 to limit distal movement of the dosing ring
`be rotated relative to the driver 24. However, the splines 86
`adaptor 28.
`are formed such to allow the dosing ring 22 to axially move
`Referring to FIG. 11, in a rest state, the dosing ring 22 is
`along the length of the keyways 74. Also, as shown in FIG.
`9, the grooves 76 are preferably formed on the proximal end 50 urged into a rest position with the grooves 76 being spaced
`from the teeth 100 of the dose knob 20. Accordingly, the
`78 to face axially and are formed about the entire periphery
`dose knob 20 can be freely rotated without rotating the
`thereof, more preferably, at equal intervals. The grooves 76
`dosing ring 22. In this manner, the dose knob 20 can be
`are separated by partitions 88, which may be rounded to
`rotated within the body 18 (with rotational movement being
`facilitate engagement of the grooves 76 with the teeth of the
`55 translated into axial displacement) and set to a desired
`dose knob 20 described below.
`dosage in a manner similar to prior art devices. With the dose
`The dose knob 20 is generally tubular having open
`knob 20 thus translating, the dosing ring adaptor 28, the
`proximal and distal ends 90 and 92, respectively. A textured
`biasing means 106 and the dosing ring 22 move therewith,
`handle 94 is formed in proximity to the distal end 92 which
`while the dosing ring 22 remains in its rest position. The
`is engageable by a user to rotate the dose knob 20 in setting
`the pen 10 to a desired dosage amount. The dose knob 20 60 dosing ring 22 slides axially long the driver 24 as a proper
`dose is selected. The subject invention, unlike the prior art,
`includes one or more thread portions 95 (FIG. 11) formed to
`allows the dose knob 20 to be "dialed back" freely if a
`threadedly engage the dose setting thread 54 of the body 18.
`desired dosage amount is inadvertently by-passed, without
`Accordingly, the dose knob 20 may be rotated within the
`the undesirable and costly effect of expelling medication.
`body 18 resulting in translation of that rotation to axial
`In a preferred embodiment, with a desired dosage amount
`displacement of the dose knob 20 relative to the body 18 in 65
`setting a desired dosage. Dosage indicia (not shown) may
`being set, the ratchet arms 96 advantageously provide hold­
`also be disposed externally of the dose knob 20.
`ing force to maintain the desired radial position of the dose
`
`Mylan Exhibit - 1016
`Mylan v. Sanofi
`
`

`

`US 6,932,794 B2
`
`5
`
`5
`6
`knob 20 relative to the dosing ring 22, and, thus, to the driver
`groove are cooperatively engaged with each other such
`that said dosing ring is rotatable with said dose knob
`24. In other words, the dose knob 20 cannot rotate without
`when said dosing ring is in said second position.
`overcoming this holding force.
`2. A pen as in claim 1, further comprising biasing
`means
`The needle cannula may be attached to the pen 10 prior to
`to urge said dosing ring into said first position.
`or after setting the desired dosage, as a matter of user
`3. Apen as in claim 2, wherein said biasing means is a coil
`preference. Once the needle cannula has been prepared,
`spring.
`attached to the cartridge holder 14, and inserted into the
`4. A pen as in claim 1, wherein said second position is a
`patient, the thumb button 30 is depressed. Initially, the
`medication delivery position in which said pen is used to
`applied force will act against the biasing means 106 causing
`deliver medication.
`initial straight-line motion of the dosing ring adaptor 28 and 1°
`5. Apen as in claim 1, wherein said dosing ring having a
`eventual interengagement of the grooves 76 and the teeth
`plurality of longitudinal ribs, said dose knob having at least
`100, as shown in FIG. 12. Additional force will cause the
`one inwardly biased ratchet arm to resiliently act against
`dose knob 20 to rotate in descending along the dose setting
`said ribs upon relative motion between said dosing ring and
`thread 54 in a proximal direction. With the interengagement
`said dose knob.
`of the grooves 76 and the teeth 100, the dosing ring 22 15
`6. Apen as in claim 1, further comprising a body coaxially
`rotates with the dose knob 20. In turn, the driver 24 rotates
`disposed about said dose knob, said dose knob threadedly
`with the dosing ring 22 (due to the interengagement of the
`engaging said body.
`keyways 74 and the splines 86), and the threads 68 of the
`7. A pen as in claim 1, further comprising a leadscrew
`driver 24 rotate about the threads 70 of the leadscrew 26.
`having a plurality of threads, where said driver is coaxially
`Since the leadscrew 26 cannot rotate because of its fixed 20
`disposed about a portion of said leadscrew and includes
`positioning in the aperture 46, the leadscrew 26 axially
`internal threads for threadedly engaging said leadscrew.
`translates in a proximal direction to urge the spinner 16
`8. Apen as in claim 7, further comprising a body coaxially
`against the plunger 38 in expelling medication from the drug
`disposed about said dose knob, said body including an
`cartridge 32. The volume of the drug to be expelled is
`aperture through which said leadscrew passes, said aperture
`calibrated to the settings of the dose knob 20.
`being formed to prevent rotation of said leadscrew relative
`Once a dose has been administered, the thumb button 30
`to said body.
`is released, causing the dosing ring 22 to return to its rest
`9. Apen as in claim 1, further comprising a body coaxially
`position. The dose knob 20 can then be adjusted to a zero
`disposed about said dose knob, said dose knob having an
`position ready for the next drug administration. The spinner
`externally defined thread portion, said body having an
`16 does not move in setting a dosage amount and, thus, is at
`internally defined thread for receiving said thread portion,
`a zero position after each dose administration. In the pre­
`said thread portion and said thread translating rotational
`ferred embodiment, to maintain the spinner 16 position
`movement into axial displacement when said dose knob is
`accurately, the interengagement of the ratchet teeth 52 and
`selectively rotated by a user.
`the ratchet fingers 66 prevents undesired rearward rotation
`10. A pen as in claim 9, further comprising a cartridge
`of the driver 24 that would result in the leadscrew 26 35
`holder within which the medicine cartridge may be pro­
`possibly translating distally. The administration process is
`vided.
`n A pen as in claim 10, wherein said cartridge holder is
`repeated until the drug cartridge 32 is spent. If the pen 10 is
`removably secured to said body.
`reusable, the cartridge can be replaced, whereas, if the pen
`12. Apen as in claim 10, wherein said cartridge holder is
`is disposable, the entire pen 10 may be disposed of.
`As will be appreciated by those skilled in the art, various fixedly
`secured to said body,
`modifications can be made with the spirit of the invention
`13. A medication delivery pen for expelling medication
`being maintained. For example, grooves may be formed on
`from a medicine cartridge, the medicine cartridge having a
`the dose knob and teeth on the dosing ring, or a combination
`pierceable septum sealing one end, a needle cannula being
`thereof.
`removably securable to the one end for piercing the septum,
`said pen comprising:
`While the invention has been described in relation to the
`preferred embodiments with several examples, it will be
`a leadscrew having a plurality of threads;
`understood by those skilled in the art that various changes
`a driver coaxially disposed about a portion of said lead-
`may be made without deviating from the spirit and scope of
`screw;
`the invention as defined in the appended claims.
`a dosing ring non-rotatably disposed on said driver and
`What is claimed is:
`axially slidable thereon and therealong;
`1. A medication delivery pen for expelling medication
`a dose knob coaxially disposed about said dosing ring and
`from a medicine cartridge, said pen comprising:
`selectively rotatable by a user, wherein said dose knob
`a driver;
`has a first feature defined thereon and said dosing ring
`a dosing ring non-rotatably disposed on said driver and 55
`has a second feature defined thereon, said first and said
`axially slidable thereon and therealong; and,
`second features being complementary with each other
`a dose knob coaxially disposed about said dosing ring,
`and being selectively operatively engageable with each
`wherein at least one tooth is formed on one of said dose
`other;
`knob and said dosing ring, and wherein at least one
`said dosing ring being biased into a first position wherein
`groove is formed on the other of said dose knob and go
`said first feature and said second feature are not opera­
`said dosing ring, said tooth and said groove being
`tively engaged with each other, said dosing ring being
`formed for selective cooperative engagement with each
`selectively movable from said first position to a second
`other;
`position in which said first feature and said second
`wherein said dosing ring is selectively movable axially
`feature are operatively engaged with each other to
`relative to said dose knob from a first position where 65
`lockingly engage said dose knob and said dosing ring
`said tooth and said groove are spaced apart from each
`so as to allow medicine to be expelled from the
`other, to a second position where said tooth and said
`cartridge through the needle cannula.
`
`50
`
`Mylan Exhibit - 1016
`Mylan v. Sanofi
`
`

`

`US 6,932,794 B2
`
`7
`8
`14. A pen as in claim 13, further comprising a coil spring
`16. A pen as in claim 15, further comprising a cartridge
`holder within which the medicine cartridge may be pro­
`for biasing said dosing ring into said first position.
`vided.
`15. A pen as in claim 13, further comprising a body
`coaxially disposed about said dose knob, said dose knob
`17. A pen as in claim 16, wherein said cartridge holder is
`having an externally defined thread portion, said body 5 removably secured to said body,
`having an internally defined thread for receiving said thread
`18. A pen as in claim 16, wherein said cartridge holder is
`portion, said thread portion and said thread translating
`fixedly secured to said body.
`rotational movement into axial displacement when said dose
`knob is selectively rotated by a user.
`
`Mylan Exhibit - 1016
`Mylan v. Sanofi
`
`