(12) United States Patent
`Giambattista et al.
`
`II
`US006248095B1
`US 6,248,095 B1
`(io) Patent No.:
`(45) Date of Patent:
`Jun. 19,2001
`
`(54) LOW-COST MEDICATION DELIVERY PEN
`
`(75)
`
`Inventors: Lucio Giambattista, East Hanover, NJ
`(US); Carlos Guillermo, East
`Hampton; John Burbank, Ridgefield,
`both of CT (US)
`
`5,304,152 * 4/1994 Sams .
`5,308,340 * 5/1994 Harris
`5,383,865 * 1/1995 Michel .
`5,514,097 * 5/1996 Knauer .
`5,584,815 * 12/1996 Pawelka et al. .
`
`604/208
`
`(73) Assignee: Becton, Dickinson and Company,
`Franklin Lakes, NJ (US)
`
`* cited by examiner
`
`( * ) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`Primary Examiner—Sharon Kennedy
`Assistant Examiner—Catherine Serke
`(74) Attorney, Agent, or Firm—Alan W. Fiedler
`
`(21) Appl. No.: 09/027,607
`Feb. 23, 1998
`(22) Filed:
`... A61M 5/00
`(51) Int. CI.7
`604/207
`(52) U.S. CI
`(58) Field of Search
`604/207, 208,
`604/209, 210, 211, 187, 218, 224; 222/32,
`637
`
`(57)
`
`ABSTRACT
`
`A medication delivery pen having very few parts allowing it
`to be manufactured at a very low-cost. The medication
`delivery pen also includes an automatic release mechanism
`to allow the user to easily reset the dose on the medication
`delivery pen and a mechanism for allowing the lead screw
`to easily retract back into the body of the medication
`delivery pen when the vial retainer has been removed to
`receive a new vial.
`
`(56)
`
`References Cited
`U.S. PATENT DOCUMENTS
`4,936,833 * 6/1990 Sams
`
`1
`
`2
`
`604/232
`
`7 Claims, 4 Drawing Sheets
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`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1021, p. 1 of 8
`
`

`

`U.S. Patent
`
`Jun. 19, 2001
`
`Sheet 1 of 4
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`US 6,248,095 B1
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`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1021, p. 2 of 8
`
`

`

`U.S. Patent
`
`Jun. 19, 2001
`
`Sheet 2 of 4
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`US 6,248,095 B1
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`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1021, p. 3 of 8
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`

`

`U.S. Patent
`
`Jun. 19, 2001
`
`Sheet 3 of 4
`
`US 6,248,095 B1
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`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1021, p. 4 of 8
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`

`

`U.S. Patent
`
`Jun. 19,2001
`
`Sheet 4 of 4
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`US 6,248,095 B1
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`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1021, p. 5 of 8
`
`

`

`1
`LOW-COST MEDICATION DELIVERY PEN
`
`US 6,248,095 B1
`
`2
`medication into the vial holder. A prior art pen body then is
`connected to the proximal end of the vial holder. The pen
`body includes a dose setting apparatus for designating a dose
`of medication to be delivered by the pen and a driving
`5 apparatus for urging the plunger of the vial distally for a
`distance corresponding to the selected dose.
`The user of the pen mounts a prior art double-ended
`needle cannula to the distal end of the vial holder such that
`the proximal point of the needle cannula pierces the elasto-
`1° meric seal on the vial. The patient then selects a dose and
`operates the pen to urge the plunger distally to deliver the
`selected dose. The dose selecting apparatus returns to zero
`upon injection of the selected dose with this prior art
`medication delivery pen. The patient then removes and
`discards the needle cannula, and keeps the prior art medi­
`cation delivery pen in a convenient location for the next
`required medication administration. The medication in the
`vial will become exhausted after several such administra­
`tions of medication. The patient then separates the vial
`20 holder from the pen body. The empty vial may then be
`removed and discarded. A new vial can be inserted into the
`vial holder, and the vial holder and pen body can be
`reassembled and used as explained above.
`The above described medication delivery pen is effective
`25 and much more convenient for self-administration of medi­
`cation than the hypodermic syringes that use separate medi­
`cation vials. However, the above-described medication
`delivery pen requires a number of parts which make the
`manufacture of these pens very expensive. Hence, it is
`30 necessary to provide a medication delivery pen having a
`simple mechanism for setting the desired dose that uses as
`few parts as necessary without losing functionality or stan­
`dard features.
`
`BACKGROUND OF THE INVENTION
`1. Field of the Invention
`The present invention relates to a medication delivery pen
`having a variety of features and, more particularly, a low-
`cost medication delivery pen having very few parts.
`2. Description of Related Art
`Hypodermic syringes are used to deliver selected doses of
`medication to patients. The prior art hypodermic syringe
`includes a syringe barrel having opposed proximal and distal
`ends. A cylindrical chamber wall extends between the ends
`and defines a fluid receiving chamber. The proximal end of
`the prior art syringe barrel is substantially open and receives 15
`a plunger in sliding fluid tight engagement. The distal end of
`the prior art syringe barrel includes a passage communicat­
`ing with the chamber. A needle cannula may be mounted to
`the distal end of the prior art syringe barrel, such that the
`lumen of the needle cannula communicates with the passage
`and the chamber of the syringe barrel. Movement of the
`plunger in a proximal direction draws fluid through the
`lumen of the needle cannula and into the chamber. Move­
`ment of the plunger in a proximal-to-distal direction urges
`fluid from the chamber and through the lumen of the needle
`cannula.
`Medication to be injected with the prior art hypodermic
`syringe often is stored in a vial having a pierceable elasto-
`meric seal. Medication in the prior art vial is accessed by
`piercing the elastomeric seal with the needle cannula. A
`selected dose of the medication may be drawn into the
`chamber of the syringe barrel by moving the plunger a
`selected distance in a proximal direction. The needle cannula
`may be withdrawn from the vial, and the medication may be
`injected into a patient by moving the plunger in a distal 35
`SUMMARY OF THE INVENTION
`direction.
`Some medication, such as insulin is self-administered.
`The present invention relates to a medication delivery pen
`The typical diabetes patient will require injections of insulin
`that addresses the aboveidentified problems. The medication
`several times during the course of the day. The required dose
`delivery pen uses only tens parts and still provides numerous
`of insulin will vary from patient to patient, and for each 40 features that have become expected by medical delivery pen
`patient may vary during the course of the day and from day
`users.
`to day. Each diabetes patient will establish a regimen that is
`The medication delivery pen according to the present
`appropriate for his or her own medical condition and for his
`invention includes a mechanism that automatically disen-
`or her lifestyle. The regimen typically includes some com-
`gages the drive mechanism from the dose control mecha-
`bination of a slow or medium acting insulin and a faster 45 nism to permit the user to reset the dose on the medication
`acting insulin. Each of these regimens may require the
`delivery pen.
`diabetes patient to periodically self-administer insulin in
`Another feature of the present invention is an automatic
`public locations, such as places of employment or restau­
`mechanism that allows the user to easily load a new vial and
`rants. The required manipulation of the standard prior art
`reposition the lead screw when the vial retainer has been
`hypodermic syringe and vial can be inconvenient and 50
`removed from the body of the medication delivery pen.
`embarrassing in these public environments.
`Medication delivery pens have been developed to facili­
`BRIEF DESCRIPTION OF THE DRAWINGS
`tate the self-administration of medication. One prior art
`FIG. 1 is an exploded perspective view of a medication
`medication delivery pen includes a vial holder into which a
`vial of insulin or other medication may be received. The vial 55 delivery pen according to the present invention,
`holder is an elongate generally tubular structure with proxi­
`FIG. 2 is a cross-sectional view of the driver in the
`mal and distal ends. The distal end of the prior art vial holder
`medication delivery pen shown in FIG. 1.
`includes mounting means for engaging a double-ended
`FIG. 3 is a partial perspective view of the distal end of the
`needle cannula. The proximal end also includes mounting
`driver shown in FIG. 2.
`means for engaging a driver and dose setting apparatus as 60
`FIG. 4 is a perspective view of the retract nut shown in
`explained further below. A disposable vial for use with the
`FIG. 1.
`prior art vial holder includes a distal end having a pierceable
`FIG. 5 is a perspective view of the reset ring shown in
`elastomeric seal that can be pierced by one end of a
`FIG. 1.
`double-ended needle cannula. The proximal end of this prior
`FIG. 6 is a cross-sectional view of the body of the
`art vial includes a plunger slidably disposed in fluid tight 65
`medication delivery pen shown in FIG. 1.
`engagement with the cylindrical wall of the vial. This prior
`art medication delivery pen is used by inserting the vial of
`FIG. 7 is a distal end view of the body shown in FIG. 6.
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1021, p. 6 of 8
`
`

`

`US 6,248,095 B1
`
`J Q
`
`3
`FIG. 8 is a perspective view of the dose set knob of the
`medication delivery pen shown in FIG. 1.
`FIG. 9 is a cross-sectional view of the medication delivery
`pen shown in FIG. 1 fully assembled and in a dose setting
`condition.
`FIG. 10 is a cross-sectional view of the medication
`delivery pen shown in FIG. 9 in a reset dose condition.
`
`4
`FIG. 5 is a perspective view of reset ring 6 having a
`plurality of keys 63 therein that travel within a respective set
`of keyways 86 on driver 8, shown in FIG. 1. Reset ring 6
`also includes a distal end 61 and a proximal end 62, proximal
`5 end 62 having a flange 65 and a plurality of ratchets 64
`extending from flange 65 to distal end 61. Ratchets 64
`engage with a plurality of ratchet fingers 73 on a distal end
`71 of dose set knob 7, shown in FIG. 8 and discussed further
`below.
`DETAILED DESCRIPTION OF THE
`FIG. 6 is a cross-sectional view of body 5 more clearly
`INVENTION
`showing distal end 51 and proximal end 52 having a set of
`A medication delivery pen 10 according to the present
`dose setting threads 58 therein together with a dose viewing
`invention is shown in FIG. 1. Medication delivery pen 10
`window 55. Another set of threads 56 located within distal
`includes a cap 1 removably attached to a vial retainer 2 so
`end 51 are used to attach vial retainer 2 in this embodiment.
`to cover vial retainer 2 between uses of medication delivery l5 of course, other means for attaching vial retainer 2 to body
`pen 10. Vial retainer 2 receives a vial (not shown) that is
`5 could also be used and fall within the scope of the present
`commonly used in such medication delivery pens to provide
`invention as long as sufScient force is applied to retract nut
`medication and/or insulin for an injection. Medication deliv­
`4 to prevent rotation of retract nut 4 and lead screw 9 within
`ery pen 10 includes a body 5 having a distal end 51 and a
`body 5 when vial retainer 2 is attached to body 5. FIG. 7 is
`proximal end 52, with vial retainer 2 being attached to distal 20 a distal end view of body 5 more clearly showing radial
`end 51 of body 5. Medication delivery pen 10 also includes
`splines 54.
`a dose set knob 7, a driver 8, a lead screw 9, a lead screw
`FIG. 8 is a perspective view of dose set knob 7 having a
`spinner 3, a retract nut 4, a reset ring 6, and a thumb button
`distal end 71 and a proximal end 72, with a textured section
`71. Each of these elements are more clearly shown in FIGS.
`76 near proximal end 72 to aide the user in turning dose set
`2-8 and are more fully described below.
`25 knob 7 to set a desired dose when using medication delivery
`FIG. 2 is a cross-sectional view of driver 8 having a distal
`pen 10. Distal end 71 includes the plurality of ratchet fingers
`end 81 and a proximal end 82, wherein distal end 81 includes
`73 that engage ratchet 64 on reset ring 6 when setting a dose,
`a snap ring 83 used to attach retract nut 4 onto distal end 81
`as shown in FIG. 9, until medication delivery pen 10 is in a
`of driver 8. In addition, driver 8 includes a plurality of
`reset condition, as shown in FIG. 10. When medication
`ratchet fingers 84 at distal end 81, as more clearly shown in 30 delivery pen 10 is in the reset condition, reset ring 6 has
`FIG. 3. These ratchet fingers 84 engage a ratchet 53, shown
`disengaged from dose set knob 7 as clearly seen in FIG. 10.
`in FIG. 6, within body 5 to allow driver 8 to rotate only in
`Alternatively, as shown in FIG. 9 during a dose setting
`one direction with respect to body 5. Driver 8 also includes
`condition, reset ring 6 is within dose set knob 7 such that
`a set of threads 85 that interface with a matching set of
`ratchet 64 are engaged with ratchet fingers 73. When a user
`threads 93 on lead screw 9, shown in FIG. 1.
`35 is turning dose set knob 7 and thereby turning reset ring 6
`because of the engagement of ratchet 64 and ratchet fingers
`FIG. 4 is a perspective view of retract nut 4 that more
`73, keys 63 within reset ring 6 interact with keyways 86 on
`clearly shows an attachment ring 41 that mates with snap
`driver 8 to cause driver 8 to rotate about lead screw 9 and
`ring 83 on distal end 81 of driver 8 to rotatably attach retract
`move driver 8 in a proximal direction along lead screw 9.
`nut 4 onto driver 8. Retract nut 4 also includes an opening
`42 therethrough having a pair of flat sides 43 that mate with 40 After a desired dose has been set by the user using dose set
`knob 7 and the desired dose is to be dispensed, movement
`set of flat sides 94 on lead screw 9, shown in FIG. 1, to
`of dose set knob 7 in a distal direction will cause driver 8 to
`prevent lead screw 9 from rotating with respect to retract nut
`push lead screw 9 in the distal direction and thereby dispense
`4. Retract nut 4 also has a distal surface 45 and a proximal
`medication from the vial.
`end 46, proximal end 46 having a set of radial splines 44 that
`mates with a set of radial splines 54 within body 5 to prevent 45
`The user sets a desired dose by rotating dose set knob 7
`retract nut 4 and lead screw 9 from rotating when these
`in a counter clockwise direction until the desired dose is
`splines 44 and 54 are engaged. As more clearly shown in
`displayed in dose display window 55 in body 5. Dose set
`FIG. 9, these splines 44 and 54 are fully engaged when vial
`knob 7 includes a plurality of dosage numerals 74 that show
`retainer 2 is mounted onto body 5 and accordingly prevent
`through window 55 and an "R" 75 that identifies a "reset
`retract nut 4 and lead screw 9 from rotating with respect to so condition" for medication delivery pen 10. When the desired
`body 5. However, when vial retainer 2 is not mounted into
`dose is reached, the user depresses a thumb button 71
`body 5, retract nut 4 and lead screw 9 are free to rotate which
`attached to proximal end 72 of dose set knob 7 until dose set
`permits lead screw 9 to be free to backdrive into body 5 as
`knob 7 has fully returned within body 5.
`the user pushes a new vial into place. A lead screw spinner
`A significant function of the drive mechanism within
`3 is attached to a distal end 91 of lead screw 9 and is allowed 55 medication delivery pen 10 is that if the user overshoots the
`to spin freely on lead screw 9, shown in FIG. 1, in relation
`desired dose, medication delivery pen 10 can be reset so that
`to a rubber plunger (not shown) within the vial as lead screw
`the user may redial for the desired dose. This is accom­
`9 is backdriven into body 5.
`plished by rotating dose set knob 7 completely past the
`When vial retainer 2 locks retract nut 4 into mating radial
`maximum value (30 or 60) until an "R" on dose set knob 7
`splines 54 within body 5, lead screw 9 is locked against 60 is displayed in window 55 within body 5. This disengages
`rotation which then enables threads 85 within driver 8 to
`ratchet fingers 73 within dose set knob 7 from ratchet 64 on
`drive lead screw 9 in the distal direction towards and against
`reset ring 6 by forcing them apart and releasing reset ring 6
`from within dose set knob 7. This action is caused by keys
`the rubber plunger within the vial during a dispensing
`63 engaging with a set of stops 87, shown in FIG. 1, at a
`operation. Snap ring 83 on driver 8 also allows retract nut 4
`to float captive thereon thus trapping it from spinning down 65 proximal end of each keyway 86 on driver 8. Dose set knob
`lead screw 9, when exchanging vials should a user invert
`7 is then free to rotate back to an initial dose position ("0")
`medication delivery pen 10 when changing vials.
`upon which ratchet fingers 73 are forced to reengage with
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1021, p. 7 of 8
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`

`

`US 6,248,095 B1
`
`10
`
`6
`5
`2. The medication delivery pen according to claim 1,
`ratchet 64 on reset ring 6. Disengaging and re-engaging
`ratchet 64 and ratchet fingers 73 requires significant tactile
`wherein said body further includes a dose display window
`manipulation and results in an audible click which alerts the
`and said reset condition is defined by a "R" on said dose set
`user that the resetting function has been performed.
`knob that is displayed in said dose display window.
`While the present invention has been described with 5
`3. The medication delivery pen according to claim 1,
`respect to a preferred embodiment, it is apparent that various
`wherein said reset mechanism includes a reset ring that
`changes can be made without departing from the scope of
`travels on said driver and rotates said driver as said dose set
`the invention as defined by the appended claims.
`knob is rotated during a dose setting condition.
`What is claimed is:
`4. The medication delivery pen according to claim 3,
`1. A medication delivery pen comprising:
`wherein said reset ring includes a ratchet that engages with
`a body having a distal end and a proximal end and
`a ratchet finger on said dose set knob to cause said reset ring
`including:
`to rotate with said dose set knob, wherein said ratchet finger
`a dose control mechanism for setting a desired dose to be
`and said ratchet are disengaged when said dose set knob is
`delivered and initiating a reset condition;
`15 moved from the dose setting condition to a reset condition.
`a drive mechanism for dispensing the desired dose, said
`5. The medication delivery pen according to claim 4,
`drive mechanism including a leadscrew having a set of
`wherein said reset ring further includes a key that engages
`threads and a driver having a set of threads that engage
`with a keyway on said driver to rotate said driver as said
`with the set of threads on said leadscrew to drive said
`dose set knob and said reset ring are rotated during the dose
`leadscrew in a distal direction during dispensing; and 20
`setting condition.
`a reset mechanism that is selectively activated by said
`6. The medication delivery pen according to claim 1,
`dose control mechanism for disengaging said drive
`further comprising:
`mechanism from said dose control mechanism when
`a vial retainer that mounts to said distal end of said body;
`said dose control mechanism initiates the reset condi­
`and
`tion to permit a new desired dose to be set by said dose 25
`a reload mechanism that disengages said drive mechanism
`control mechanism without having to use said drive
`when said vial retainer is removed from said body to
`mechanism to dispense the previously set desired dose,
`allow a user to reload said medication delivery pen.
`said reset mechanism including an alert mechanism that
`7. The medication delivery pen according to claim 6,
`alerts a user that the reset condition has been initiated,
`wherein said dose control mechanism includes a dose set 30 wherein said reload mechanism includes a retract nut in said
`body between said vial retainer and said drive mechanism
`knob rotatably mounted within said body and attached
`that causes the drive mechanism to disengage when said vial
`to said drive mechanism by said reset mechanism
`retainer is removed from said body to allow a user to reload
`during a dose setting condition, and
`wherein said reset mechanism disengages said dose set
`said medication delivery pen.
`knob from said driver when said dose set knob initiates 35
`the reset condition.
`
`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
`
`Ex. 1021, p. 8 of 8
`
`