CA2232005C - Medication delivery pen with cap actuated dose delivery clutch - Google Patents

Medication delivery pen with cap actuated dose delivery clutch Download PDF

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Publication number
CA2232005C
CA2232005C CA002232005A CA2232005A CA2232005C CA 2232005 C CA2232005 C CA 2232005C CA 002232005 A CA002232005 A CA 002232005A CA 2232005 A CA2232005 A CA 2232005A CA 2232005 C CA2232005 C CA 2232005C
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CA
Canada
Prior art keywords
lead screw
clutch
medication
pen
cap
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related
Application number
CA002232005A
Other languages
French (fr)
Other versions
CA2232005A1 (en
Inventor
Lawrence H. Chanoch
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Becton Dickinson and Co
Original Assignee
Becton Dickinson and Co
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Becton Dickinson and Co filed Critical Becton Dickinson and Co
Publication of CA2232005A1 publication Critical patent/CA2232005A1/en
Application granted granted Critical
Publication of CA2232005C publication Critical patent/CA2232005C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
    • A61M5/31583—Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod
    • A61M5/31585—Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod performed by axially moving actuator, e.g. an injection button
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31535—Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31548—Mechanically operated dose setting member
    • A61M5/3155—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe
    • A61M5/31551—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe including axial movement of dose setting member
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31548—Mechanically operated dose setting member
    • A61M5/31556—Accuracy improving means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31535—Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
    • A61M5/31543—Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose piston rod reset means, i.e. means for causing or facilitating retraction of piston rod to its starting position during cartridge change

Abstract

A medication delivery pen is provided having a medication cartridge assembly, a pen body assembly and a cap. The pen body assembly includes a dose setting mechanism and a dose delivery mechanism that are selectively disconnected and connected by attaching and removing, respectively, the cap of the medication delivery pen. When the cap is attached to the medication delivery pen the user can easily dial in and correct the dialed in dosage and when the cap is removed the medication delivery pen is ready to dispense the dialed in dosage.

Description

IJNITED STATES PATENT APPLICATION

MEDICATION DELIVERY PEN WITH CAP ACTUATED DOSE DELIVERY CLUTCH

BACKGROUND OF TIIE INVENTION

0 1. Field of the Il~v~lllion The subject ir.vention relates to a me liç~ti(~n delivery pen having a cap ~ct l~t~
clutch that rli~conn~ct~ a dose setting meçh~ni.cm from a dose delivery mech~ni.~m when the pen is capped and conne~ the dose setting m~h~ni~m to the dose delivery 5 m~h~ni~m when the pen is uncapped.
2. D~ L;on of Related Art Hypodermic syringes are used to deliver selected doses of medication to 20 p~ti~.nt~ The prior art hypodermic syringe in~ cies a syringe barrel having opposed lU~illlal and distal ends. A cylindriç~l chamber wall extends between the ends and defines a fluid receiving chamber. The ~io~llal end of the prior art syringe barrel is subst~nti~lly open and receives a plunger in sliding fluid tight engagement. The distal end of the prior art syringe barrel includes a passage co.. -.. ic~ting with the chamber.
2s A needle ç~nnnl~ is mounted to the distal end of the prior art syringe barrel, such that the lumen of the needle ç~nnlll~ communicates with the passage and the chamber of the syringe barrel. Movement of the plunger in a proximal direction draws fluid through SU~IllUTE SHEET(RULE 26) W O 97/10865 PCTrUS96/14742 the lumen of the needle c~nn~ and into the chamber. Movement of the plunger in av,dil--al-to-distal direction urges fluid ~rom the chamber and through the lumen of the needle c~nm-l~

s l~eAif~ti~n to be injected with the prior art hypodermic syringe often is stored in a vial having a pierceable elastomeric seal and ~I~ceseeA by piercing the elastomeric seal with the needle c~nn~ A s~l~ct~l dose of the meAi~tion may be drawn into the chamber of the syringe barrel by moving the plunger a select~l ~liet~nc,e in a ~ dill~al direction. The needle c~nm~l~ is then withdrawn from the vial, and the medication is injected into a patient by moving the plunger in a distal direction.

Some medication, such as insulin is self-~lminietered. The typical diabetes patient will require injections of insulin several times during the course of the day. The l~ui.ed dose of insulin will vary from patient to patient, and for each patient may vary during the course of the day and from day to day. Each diabetes patient will establish a regimen that is a~ pliaLe for his or her own meAic,~l condition and for his or her lifestyle. The lG~ len typically inclllcies some comhin~ti-)n of a slow or m~Aillm acting insulin and a faster acting insulin. Each of these regimçne may require the dial~eLes patient to periodically self-~lminiet~-r insulin in public locations, such as places of employment or lc;~ c. The required manipulation of the standard prior arL
hypodermic syringe and vial can be inconvenient and embarrassing in these publicenvironments.

Meflic~tion delivery pens have been developed to f~cilit~te the self-~lminiet~ti~n of medication. One prior art me lic~tion delivery pen inçl~ e a vial holder into which a vial of insulin or other medication may be received. The vial SU~;~ 111 UTE SHEET (RULE 26) WO 97/10865 PCT~US96/1474~
holder is an elongate generally tubular structure with proximal and distal ends. The distal end of the prior art vial holder includes mounting means for en~ing a double-ended needle ~nmll~ The proximal end also in-~hldes mounting means for eng~ging a driver and dose setting a~paldlus as explained further below. A disposable vial for use s with the prior art vial holder inrlu-~es a distal end having a pierceable elastomeric seal that can be pierced by one end of a double-ended needle c~nnl-l~ The l-lv~ullal end of this prior art vial includes a plunger slidably disposed in fluid tight engagement with the cylin~lric~l wall of the vial. This prior art mY~ ti~n delivery pen is used by inserting the vial of medication into the vial holder. A prior art pen body then is 0 conn~o-cted to the proximal end of the vial holder. The pen body in~ des a dose setting d~Jaldlus for ~lesign~ting a dose of m~lic~tion to be delivered by the pen and a driving a~ alalus for urging the plunger of the vial distally for a ~ t~nce corresponding to the selected dose.

1S The user of the pen mounts a prior art double-ended needle e~nmll~ to the distal end of the vial holder such that the ~l~,~-lal point of the needle ~nmll~ pierces the el~tom~ric seal on the vial. The patient then selects a dose and operates the pen to urge the plunger distally to deliver the sel~cted dose. The dose selecting ~dlUSreturns to zero upon injection of the selocte~l dose with this prior art m~ic~tion 20 delivery pen. The patient then removes and discards the needle c~nnlll~, and keeps the prior art me lic~tion delivery pen in a convenient location for the next required m~1ic~ti~n ?~lmini~tT~tion The m~Aic~tion in the vial will become e~ch~ t~l after several such a~lmini~trations of m~li~tion. The patient then s~aldles the vial holder from the pen body. The empty vial may then be removed and discarded. A new vial 2s can be inserted into the vial holder, and the vial holder and pen body can be re~semhled and used as explained above.

Sl,~;~ JTE SHEET (RULE 26) W O 97/10865 PCTAUS96/1474~

The above described reusable medication delivery pen is effective and much more convenient for self-~dminictration of medication than the typical hypodermic syringe and separate me 1ic~tion vial. However, the ~ embly of t_e pen to remove5 empty medic~ti-n vials and to insert new ones is an inconvenience. As a result, disposable pens have been developed. l'he prior art disposable medication delivery pen in~hldes a vial of insulin or other such meAic~tic n perm~nP.ntly encapsulated therein.
The patient need merely c~nn-oct a double-ended needle c~nnul~ to the disposable pen for each ~-lmini~f~tion of me~1ic~ti~7n. The prior art disposable pen can be discarded o when the supply of mPAic~tiQn perm~nPntly encapsulated therein has been e~chz-l-stPA

Disposable medication delivery pens offer certain conveni~n-~s to the patient who is required to seLf-~dmini~ter mP~ic~ti~n. However, the dose sçlecting and driving mP~h~ni~m~ of prior art meAic~ti-~n delivery pens are fairly complex devices and costly 15 to m~n~ tllre. Hence, a sub~ ial cost pénalty is associated with the convenience of using a disposable meAic~ti~m delivery pen.

Another problem with the above-described meAic~tion delivery pens is with the ~liffi~ulty in setting the desired dose caused by space limit~tions on the dose setting 20 mech~ni~m for dose in~ic~ting numbers. For example, the dose setting mech~ni~m may not be able to make more than one full rotation and will therefore require space for a return track to correct for dose settings higher than desired.

Sl,.,S ~ ITE SHEET (RULE 26) W O 97/10865 PCT~US96/14742 SUMMARY OF THE INVENTION

It is an objective of the present invention to overcome the above problems of the prior art by providing a meAic,~tion delivery pen having a cap ~ctl-~t~l clutch that s automatically disconnects a dose setting mechanism from a dose delivery mech~ni~m when the pen is capped and automatically connects the dose setting mechanism to the dose delivery mechanism when the pen is uncapped. Such an arrangement provides for a multi-turn dose setting knob to be used in the m~Ai~tinn delivery pen, since the connect/disconnect clutch betweell the dose setting m~h~ni~m and the dose delivery 0 mech~ni~m permits the dose setting knob to be turned in both an up direction and a down direction when the cap is attached and elimin~tPs the need for a return track.

In particular, the mt-Aic~ti{~n delivery pen of the present invention includes ameAic~ti~n cartridge assembly that is selectively engageable with and ~ en~ge~ble 5 from a pen body assembly cu.~ g the cap ~c,tl-~tt-A connect/disconnect clutch. The m~Aic~ti~n cartridge assembly is an elongate generally cylin-lric~l structure having opposed plvxi~llal and distal ends. The distal end of the medication cartridge assembly in~lu~le5 needle mounting means for securely but releasably receiving a needle c~nn~
assembly and a pierceable elastomeric seal that may be repeatedly and resealablepierced by the pl~ al end of a double-ended needle c~nmll~ The proximal end of the moAic~ti(~n cartridge assembly inclll~es body mounting means for securely but releasably mounting the meAic~tinn cartridge assembly to the pen body assembly. The meAic~ti~-n cartridge assembly further includes plunger means slidably disposed in fluid tight engagement therein that is initially disposed in a proximal position within the meAic,~tion cartridge assembly and can be moved in a distal direction by a lead screw projecting from the pen body assembly.

SU~;~ UTE SHEET (RULE 26) WO 97/10865 PCT~US96/14742 The pen body assembly comprises an array of mounting threads to enable threaded engagement of the pen body assembly and the medication cartridge assembly.
The pen body assembly further inr,ll-(1es the lead screw for selectively ~ng;3ging the s plunger of the disposable cartridge assembly and for urging the plunger of thedisposable cartridge assembly in a distal ~li~l iOII. At least a portion of the lead screw has driving threads engaged with other portions of the pen body assembly that are operative to achieve axial movement cf the lead screw in response to axial forces exerted on a rotatable ~cct~l~t~r button mounted on the ~ imal end of the pen body lo ~pmhly~ The driving threads define the same pitch and direction as the mounting threads of the pen body assembly. As will be explained in greater de~ail below, this design f~oilit~tçs quick c~mnt~ctiQn of the pen body assembly to the me~lir~tion cartridge assembly, and further assures a virtually automatic return of the lead screw to a start position each time a new m~Air~tion car~ridge assembly is mounted to the pen body 15 asscl-lbly.

The pen body assembly also incl~ ,s a connectldisconnect clutch that causes the lead screw to engage with tabs on an anti-rotation ring to prevent relative rotation bc~ the lead screw and the disposable cartridge assembly when the pen is not 20 capped. When the pen is capped, the connect/disconnect clutch causes the anti-rotation ring to ~ .sn~r, from the lead screw and permits the lead screw to be free to rotate relative to the disposable cartridge assembly.

The pen body assembly further comprises a dose setting means for establishing 25 and precisely controlling the amount of medication to be delivered in response to each actuation of the actuator button. The dose setting means may be any of several SIJ~S 1 l l ~ITE SHEET (RULE 26) structures one of which is described in greater detail below.

These and other aspects, features and advantages of the present invention will become appalGIll from the following det~ d description taken in conjunction with the ~ s accoll"~al-ying drawings.

DESCRIPTION OF T~IE DRAW~GS

Fig. 1 is a perspective view of the medication delivery pen of the subject 10 invention;

Fig. 2 is a perspective view of the pen body assembly of the meAjc~tion delivery pen shown in Fig. 1 with the cap removed;

Fig. 3 is a exploded perspective view of the pen body assembly of the m~lie~tion delivery pen shown in Fig. l;

Fig. 4 is a lon~ lin~l cross-sectional view of the m.oAi~ticln delivery pen shown in Fig. 1 with the cap thereon;

Fig. 5 is a longit l~lin~l cross-sectional view of the m.oAi~ti~n delivery pen shown in Fig. 1 wilhuul the cap;

Fig. 6 is an enlarged cross-sectional view of the connect/disconnect clutch 2s section of the medication delivery pen shown in Fig. 4 with the clutch disengaged; and SU~S 1 1 1 UTE SHEET (RULE 26) CA 02232005 1998-03-12.

WO 97/10865 PCTrUS96/1474~

Fig. 7 is an enlarged cross-sectional view of the connectldisconnect clutch section of the medication delivery pen shown in Fig. 5 with the clutch engaged.

DETAILEI[) DESCRIPTION

A me~i~tion delivery pen in accordance with the subject invention is i~lentifi~dgenerally by the n-lmer~l 10 in Figs. 1-7. Mesli~tion delivery pen 10, as shown in Figs. 1, 2 and 3, in~lud~s a pen body assembly 100, a cap 200, a cartridge assembly 300, and a needle c~nmll~ assembly 500. Cartridge ~embly 300 in~ ldes opposed vx~-lal and distal ends 301 and 302, respectively. Proxirnal end 301 of cartridge assembly 300 is ~limt~.n.~ioned and configured to threadedly engage pen body ~emhly 100 and in' llltles a pair of slots 306, as expIained further herein. Distal end 302 of cartridge assembly 300 is configured to securely but releasably engage needle c~nn assembly 500.

The picfell~d embodiment of pen body assembly 100 is illn~t~t~ in detail in Figs. 1-7. It is Im-l.orstclod, however, that variations from this pl~fe.lc;d embodiment may be provided, and are considered to be within the scope of the subject invention.
Pen body assembly 100 in~ ldes a generally cylindrical housing 101 having opposed proximal and distal ends 102 and 103, and a sub~ lly hollow throughbore 104 ext~.n-ling axially Lh~ ~ugh. An array of external threads 105 extends proximally from distal end 103 for threaded engagement with threads 303 in proximal end 301 of cartridge ~.csçm~ly 300. Portions of hollow throughbore 104 of housing 101 ~ CÇn~
2~ distal end 103 are char~ct~ri~ by an array of clutch teeth (not shown) molded therein.
Proximal end 102 of housing 101 is characterized by a cut-out 106 formed therein for SUt~ JTE SHEET (RULE 26) CA 0223200~ 1998-03-12 W O 97/10865 PCT~US96/14742 receiving a window insert 150 having a window 151 and a button 152.

Pen body assembly 100 further includes a nut 110 having opposed proximal and distal ends 111 and 112, respectively. Exterior surface regions of nut 110 between proximal and distal ends 111 and 112 define a plurality of longit~--lin~lly exten-ling splines 113. Proximal end 111 of nut 110 is characterized by a plurality of lon~tu-lin~lly e~ct~.n-ling resilient fingers 114 with enlarged ends that enable snap engagement of nut 110 into other portions of pen body assembly 100 as explained further herein. Distal end 112 of nut 110 is radially enlarged to limit axial movement 0 of nut 110 into distal end 103 of housing 101. Thus, nut 110 is axially con~t~inPA
within housing 101. However, the ~limen~ions and configurations of nut 110 and ho-lsing 101 permit free relative rotation the~ ween.

Pen body assembly 100 further inrhlc~es a clutch assembly 140 having a al clutch 141, a distal clutch 143 and an annular spring 142 biasingly engaged Ih~,.~cilweell. Pr~.lal and distal clutches 141 and 143 are both configured for non-rotatable engagement over splines 113 of nut 110. Distal clutch 143 includes an array of distaUy facing saw teeth 144 ~limen~ioned~ disposed and configured for engagement with the teeth (not shown) on the interior of housing 101, such that distal clutch 143 can rotate only in one direction relative to housing 101. Proximal clutch 141 includes an a~ay of pl~xilllally facing teeth 145 which are also configured for unidirectional rotation as exl l~in.-~1 further herein.

Pen body assembly 100 further includes a generally cylin~iric~l driver 450 2~ having opposed proximal and distal ends 451 and 452. Driver 450 is slidably inserted into housing 101 of pen body assembly 100 such that distal end 452 of driver 450 is g SIJ~S 111 ~JTE SHEET (RULE 26) snap fit over the enlarged ends of resilient fimgers 114 at proximal end 111 of nut 110.
This snap fit engagement prevents axial movement between nut 110 and driver 450, but permits free relative rotational movement within housing 101. Distal end 452 of driver 450 is also ch~r~cteri7Pd by an array of saw teeth 453 that engage with the saw teeth s 145 on proxirnal clutch 141. Outer surface regions of driver 450 are characteri7ed by splines 454 extPn-1ing radially uutwa~ly thereon and along a substantial portion of the length of driver 450.

Pen body assembly 100 further in~lndes a dose knob 400 which is a hollow o generally cylinrlric~l structure having opposed proximal and distal ends 401 and 402 and opposed inner and outer surfa~-çs 403 and 404. Inner surface 403 is ch~ terized by longitu-lin~lly P~ctPn~ling grooves 405 which are disposed and ~iimp~n~ioned for engagement with splines 454 on driver 450. More particularly, dose knob 400 is spline mounted over driver 450 within housing 101 of pen body assembly 100. Thus, axially extPn-lin~ grooves 405 in dose knob 400 ellgage splines 454 of driver 450 to pl~vellt relative rotation ILe~ ween, but pe....ill;.~ relative axi~l movement. Outer surface 404 of dose knob 400 is characterized by a helical groove 406 with dosage indicia to define dose amounts corresponding to dirr~lcLL positions along helical groove 406, as explained further herein. Helical groove 406 wraps around dose knob 400 a number of times to permit numerous rotations of dose knob 400. Proximal end 401 of dose knob 400 is çh~r~ctpri7e~l by a gnarled exterior surface to f~cilit~tP manipulation for setting a sel~tP~I dose having an actuator button 407 snapped therein to permit relative rotation Lh~,lcbeLweell.

Insert 150 is snapped into engagement with cut-out 106 in the proximal end 102 of housing 101. Insert 150 inc~ es a window 151 therethrough and a button 152 on an SUBSTITUTE SHEET (RULE 26) CA 0223200~ 1998-03-12 WO 97/10865 PCT~US96/14742 interior face that is dimensioned and disposed to engage with helical groove 406 on dose setting knob 400. Button 152 and window 151 are disposed to also enable thedosage indicia on dose setting knob 400 to be visible through window 151 as dose knob 400 is rotated.
S
Pen body assembly 100 incl~ es a lead screw 120 with opposed proximal and distal ends 121 and 122 and an array of external threads 123. External threads 123 are characterized, however, by a pair of opposed axially e~ten-1ing grooves 124 which extend from an enlarged head 125 at distal end 122 sub~t~nti~lly to the proximal end 0 121. Threads 123 are threadably eng~g~l in nut 110, such that p~ .al end 121 of lead screw 120 is within housing 101 and distal end 122 projects distally beyondhou~ing 101. Threads 123 on lead screw 120 have exactly the same pitch and the same hand as threads 105 on distal end 103 of housing 101.

Pen body assembly 100 further in~ os an anti-rotation ring 160 having a pair of tabs 161 t;~lP~ g therein and clutch teeth 162 on its pl~ al surface. Each tab 161 slidable engages groove 124 on lead screw 120 to allow anti-rotation ring 160 to travel on and rotate with lead screw 120. Thus, lead screw 120 can slidably moverelative to anti-rotation tabs 161, but is prevented from rotating relative to tabs 161.
Pen body assembly 100 also in-lndes a connect/discolme~L clutch 170 a pair of projections 172 that are received by slots 306 on cartridge assembly 300.
Connect/disconnect clutch 170 also in~lndes clutch teeth 171 that engage with or~ en~ge from clutch teeth 162 on anti-rotation ring 160, when cap 200 is on or off pen body assembly 100, respectively. For example, when cap 200 is not attached to pen body assembly 100 as shown in Figs. 2, 5 and 7, clutch teeth 171 on clutch 170 are urged in a proximal direction by a spring 175 to engage with clutch teeth 162 on Sl,~ 111 UTE SHEET (RULE 26) WO 97/1086S PCT~US96/1474~

anti-rotation ring 160 and thereby prevent rotation of lead screw 120. However, when cap 200 is mounted on pen body assembly 100, clutch 170 is ~ e.n~ged from anti-rotation ring 160 SO that lead screw 120 is free to rotate in both directions to permit a user to easily set and modify the desired dosage by rotating the dose setting knob 400.
Pen body assembly 100 is assembled by placing nut 110 into holl~ing 101 from distal end 103. Clutch assembly 140 then is mounted over splines 113 on nut 110.Driver 450 is then inserted into l~lv~ al end 102 of housing 101, and is urged ~"rl'ir~ ly in a distal direction for snap fit engagement with nut 110. In this snapped o ~.n~gement, saw teeth 144 of distal clutch 143 will be secured in engagement with the teeth in housing 101, and the saw teeth 145 of proximal clutch 141 will be engaged with saw teeth 453 at distal end 452 of driver 450. Spring 142 will m~int~in constant selecte~l ~res~ul~ between these interengaged saw teeth. Insert 150 then is positioned over dose knob 400 such that button 152 of insert 150 is engaged in the helical groove 15 406 in dose knob 400. The lell~vl~ily ~ lçd insert 150 and dose knob 400 thenare urged into housing 101. Lead screw 120 then is threaded into nut 110, and actuator button 407 is snapped into engagement with ~rux~nal end 401 of dose knob 400.

Cartridge ~ e.mhly 300, shown in detail in Figs. 1, 4 and 5, inel~des a molded 20 housing 304 which extends from proxLmal end 301 to distal end 302 of cartridge assembly 300. Housing 304 incl~l-les a mounting cavity 305 extending inwardly from proximal end 301. Mounting cavity 305 is characterized by an array of int~ l threads 303 for threaded engagement with çxtern~l threads 105 on distal end 103 of housing 101. Slots 306 located on ~ Lilnal end 301 of cartridge holder assembly 300 receive 25 IJlullusions 172 on clutch 170 when cartridge holder assembly 300 is threaded onto housing 101 to prevent clutch 170 from rotating with respect to lead screw 120.
,~

SUBSTITUTE 5HEET (RULE 26) Cartridge holder assembly 300, further inclll-les a me~lie~ti~n cartridge 350 securely retained in housing 304 between proximal end 301 and distal end 302 of cartridge assembly 300. M~ tinn cartridge 350 inr,l~ es an open proximal end 351and a distal end 352 having a pierceable elastomeric seal 353 securely mounted thereto.
A cap 354 extends b~;tweell housing 304 and cartridge 350 for securely and perrn~nPntly holding medication cartridge 350 in housing 304. A plunger 355 is disposed in sliding fluid tight engagement in cartridge 350. As shown in Fig. 4,plunger 355 initially is disposed subst~nti~lly ~ eent proximal end 351 of melic~tion o cartridge 350. Portions of cartridge 350 between plunger 355 and seal 353 are filled with a medication 356, such as insulin.

Needle c~nn~ assembly 500 includes a double ended needle ~nmll~ 501 having opposed ~lv~-lal and distal points 502 and 503, respectively, and a lumene~ten~ling axially thel~eLween. A mounting hub 504 is engaged on needle c~nn~ 501 and is removably engageable with cap 354 of cartridge holder assembly 300. The relative location of mounting hub 504 ensures that proximal point 502 of needle c~nn~ 501 will pierce seal 353 when mounting hub 504 is e,n~gecl with cap 354.
Needle c~nn~ assembly 500 further in-ln~les a shield 600 removably mounted thereon for protecting against ~eci~lpnt~l needle sticks until imm~li~tely prior to use of pen 10.

As noted above, pen body assembly 10 is reusable and cartridge holder assembly 300 is disposable. More particularly, cartridge 350 in cartridge holderassembly 300 will contain a volume of medication 356 sufficient for ~lmini~tration of several doses. After exhaustion of the medication 356, cartridge holder assembly 300 will be threadedly rli,~eng~ged from pen body assembly 100 and discarded. A new SU~ JTE SHEET (RULE 26) WO 97/10865 PCT~US96/14742 cartridge holder assembly 300 may then be mounted to the pen body assembly 100. To effect the mounting of a new cartridge holder assembly 300 to the pen body assembly 100, the patient need merely advance distal end 122 of lead screw 120 into cartridge holder assembly 300 until distal end 122 of lead screw 120 engages plunger 355.
s Assembly contin-lcs by merely exerting axial forces on thumb swivel 407 and on cartridge holder assembly 300 Additionally, friction between plunger 355 and cartridge 350 and fluid forces exerted by meAi~z3ti~n 356 and seal 353 will prevent axial adv~ncPm~nt of lead screw 120 beyond the position depicted in Fig. 4 during assembly.
Additionally, the splined engagement of distal clutch 143 with nut 110 and the 0 en~g~Pmpnt of teeth 144 on distal clutch 143 with the corresponding teeth in housing 101 prevent in~1ep~nrl-p~nt rotation of nut 110 during this initial mounting of pen body assembly 100 with a new disposable cartridge assembly 300. Thus, axial forces exerted on thumb swivel 407 will cause cartridge housing 304 to threadedly advance along threads 123 of lead screw 120.
After s~lffi~ient axial adv~n~ment, threads 105 at distal end 103 of pen body housing 101 will engage intPrn~1 threads 303 at proximal end 301 of cartridge holder assembly 300. As noted above, P~tP~n~l threads 105 at distal end 103 of housing 101 have exactly the same pitch and hand as threads 123 on lead screw 120. Hence, further axial forces exerted on thumb swivel 407 will cause the ~imlllt~n_ous threaded adv~n~PmPnt of housing 101 along lead screw 120 and into cavity 305 at proximal end 301 of cartridge holder assembly 300. Thus, because of their i~iPntir~l phc~hPs, lead screw 120 will move proximally relative to pen body housing 101, while pen body housing 101 and cartridge holder assembly 300 are approaching their fully seated and threaded condition.

S~ S 1 l l ~JTE SHEET (RULE 26) CA 0223200~ 1998-03-12 W O 97/10865 PCTAJS96/1474~
The assembled pen body assembly 100 and cartridge assembly 300 may be stored until a sel~tec- dose of medication is required. Just prior to use, a needle cz.nn~-lz. assembly 500 may be threadedly engaged to distal end 302 of cartridgeassembly 300. This threaded engagement will cause proximal tip 502 of needle cannula s 501 to pierce seal 353 and provide co.. ~ ic~.tion with mç~icz.tion 356. Shield 60Q
may then be removed.

A desired dose of me~ .z.tion 356 is then set by zittzi~.hing cap 200 to pen body assembly 100 which causes clutch 170 to f~i~engz~ge from anti-rotation ring 160 and o permit rotation of dose knob 400 until dosage indicia corresponding to the desired dose appears in window 151 of insert 150. The engagement of button 152 on insert 150 in helical groove 406 in dose knob 400 will cause a threaded retraction of dose knob 400 relative to houcing 101 of pen body assembly 100. This threaded retraction of dose knob 400 will cause a ~imllltznt-ous rotation of driver 450 splined thereto. However, nut 110 will not rotate because saw teeth 144 on distal clutch 143 and the saw teeth on the interior of housing 101 are locked to prevent rotation in that direction. Proximal clutch 141 is splined to nut 110, and hence also will not turn. However, saw teeth 453 at distal end 452 of driver 450 are shaped to allow rotation relative to p~ .al clutch 141 and provide an audible click for each unit of me~ tion in the sele~t~l dose. This iS helpful for visually ~ d patients who may be required to set doses and ~lmini.~ter insulin or other m~ic~tion to themselves. Annular spring 142 contributes to the eng~ment that provides these audible clicking sounds.

When the desired dose is set cap 200 is removed from pen body assembly lO0, which causes clutch 170 to engage with anti-rotation ring 160 to thereby preventrotation of lead screw 120. Injection is then achieved by merely pushing on actuator SUBSTITUTE SHEET (RULE 26) W O 97/10865 PCT~US96/14742 button 407. This causes dose knob 400 to turn about helix 406 relative to pen body housing 101, and driver 450 rotates through the same number of degrees. This rotation is opposite to the rotation generated by the dose setting procedure, and the rotational freedom of the clutch assembly 140 is reversed. Thus, as driver 450 turns the s previously clicking proximal clutch 141 is locked to and turns with driver 450. This driving movement of ~ ihnal clutch 141 causes a corresponding rotational movement of nut 110 because of the splined engagement therebetween. Distal clutch 143 is now free to rotate against the saw teeth on housing 101, and makes an audible fli~king in~ tion during injection of mPfli<~ti-)n.

Rotation of lead screw 120 is prevented by tabs 161 on anti-rotation ring 160 mating with grooves 124 in lead screw 120, since anti-rotation $ing 160 is prevented from rotating because of its engagement with clutch 170 when cap 200 is removed from pen body assembly 100. Th~,lc;rol~;, as nut 110 rotates under the driving action of ~ro~lal clutch 141 and driver 450, lead,screw 120 will be advanced axially into c~r~ri~lge holder assembly 300. This axial adv~n~emçnt of lead screw 120 causes distal end 122 thereof to urge plunger 355 distally into cartridge 350, and hence causes m~lir~ti~)n 356 to be injected through needle c~nmll~ 501. Injection will be tennin~t~d when proximal end 401 of dose knob 400 engages against proximal end 102 of pen body housing 101.

Upon completion of the injection, needle c~nn~ assembly 500 may be en~ged from cartridge holder assembly 300 and safely discarded. Cap 200 may be mounted over cartridge holder assembly 300, and pen 10 may be stored or carried in a 2s convenient location until the next dose of medication is required. A subsequent dose of me~lic~ti~-n will be set in exactly the manner as described above. However, for such a S~ JTE SHEET (RULE 26) W O 97/10865 PCTrUS96/14742 subsequent dose, lead screw 120 and plunger 355 will be in a partly advanced position as a starting point. Dose setting and injections can be carried out until all ofm~Ait~ n 356 has been used. Cartridge holder assembly 300 may then be threadedlyrli~eng~ged from pen body assembly 100, and slidably separated from lead screw 120.
5 The separated cartridge holder assembly may then be discarded and replaced as described above.

While the invention has been described with respect to a ~rer~ d embodiment, it is a~ nl that various changes can be made without departing from the scope of the o invention as defined by the appended claims. In particular, the pen body assembly may have other driving and/or clutch mech~ni~m~. Additionally, dirre.e,.~ means for preventing and/or enabling rotation during the dose setting and injection phases may be provided. Similarly, other means for mounting needle ç~nmll~ to the cartridge assembly may be provided. These various optional constructions will be ~p~lll to15 those skilled in the art after having read the subject disclosure.

SUBSTITUTE SHEET (RULE 26)

Claims (9)

What is claimed is:
1. A medication delivery pen comprising:
a cap;
a medication-containing cartridge assembly including:
an open proximal end having an array of threads, a cartridge having a pierceably sealed distal end, and a plunger in sliding fluid tight engagement within the cartridge at a location distally of said array of threads; and a pen body assembly having:
a housing with opposed proximal and distal ends, said distal end having an array of threads dimensioned and having a pitch for threaded engagement with said array of threads at said proximal end of said medication-containing cartridge assembly, a lead screw having a proximal end disposed in said housing, a distal end projecting beyond said distal end of said housing for selective engagement with said plunger, and an array of threads extending between said proximal and distal ends of said lead screw and defining a pitch substantially equal to said pitch of said array of threads at said distal end of said pen body assembly, driver means for moving said lead screw distally in said pen body assembly selected amounts, dose setting means for defining specified distances of distal travel for said lead screw corresponding to selected doses of medication to be delivered and causing said driver means to move said lead screw distally a defined specified distance corresponding to a selected dose, and clutch means for disconnecting said dose setting means from said lead screw when said cap is mounted on said pen body assembly and connecting said dose setting means to said lead screw means when said cap is not mounted on said pen body assembly.
2. The medication delivery pen of Claim 1, wherein said lead screw further comprises at least one anti-rotation groove extending axially therealong for engaging with said clutch means to prevent said lead screw from rotating when said cap is not mounted on said pen body assembly.
3. The medication delivery pen of Claim 2, wherein said clutch means comprises:
an anti-rotation ring mounted on said lead screw and having a pair of tabs extending into said anti-rotation groove on said lead screw to prevent said anti-rotation ring from rotating on said lead screw; and a disconnect/connect clutch mounted on said housing between said medication-containing cartridge assembly and said housing to disengage and engage with said anti-rotation ring and thereby disconnect said dose setting means from said lead screw when said cap is mounted on said pen body assembly and connect said dose setting means to said lead screw when said cap is not mounted on said pen body assembly.
4. The medication delivery pen of Claim 3, wherein said clutch means further comprises a spring located between said disconnect/connect clutch and said housing to force said disconnect/connect clutch into engagement with said anti-rotation ring when said cap is not mounted on said pen body assembly.
5. The medication delivery pen of Claim 2, wherein said clutch means comprises:
an anti-rotation ring mounted on said lead screw having a set of clutch teeth extending in the proximal direction and a pair of tabs extending into said anti-rotation groove on said lead screw to prevent said anti-rotation ring from rotating on said lead screw; and a disconnect/connect clutch mounted on said housing between said medication-containing cartridge assembly and said housing, said disconnect/connect clutch having a set of clutch teeth extending in the distal direction to engage with said set of clutch teeth on said anti-rotation ring, when said cap is not mounted on said pen body assembly.
6. The medication delivery pen of Claim 5, wherein said clutch means further comprises a spring located between said disconnect/connect clutch and said housing to force the set of clutch teeth on said disconnect/connect clutch into engagement with the set of clutch teeth on said anti-rotation ring, when said cap is not mounted on said pen body assembly.
7. The medication delivery pen of Claim 1, wherein:
said medication-containing cartridge assembly further comprises a pair of slots at a distal end; and said clutch means comprises a pair of protrusions that are received by said slots to prevent said clutch means from rotating with respect to said medication-containing cartridge assembly.
8. The medication delivery pen of Claim 7, wherein said lead screw further comprises at least one anti-rotation groove extending axially therealong for engaging with said clutch means to prevent said lead screw from rotating with respect to said medication-containing cartridge assembly, when said cap is not mounted on said pen body assembly.
9. The medication delivery pen of Claim 1, wherein said sealed end of said cartridge comprises a pierceable elastomeric seal, and wherein said medication-containing cartridge assembly further comprises needle mounting means at a distal end, said medication delivery pen further comprising a needle cannula assembly having a hub selectively engageable with said needle mounting means and a double-ended needle having opposed proximal and distal points, said proximal point of said needle being dimensioned and disposed to pierce said seal upon engagement with said medication-containing cartridge assembly.
CA002232005A 1995-09-19 1996-09-12 Medication delivery pen with cap actuated dose delivery clutch Expired - Fee Related CA2232005C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US08/530,556 US5674204A (en) 1995-09-19 1995-09-19 Medication delivery pen cap actuated dose delivery clutch
US08/530,556 1995-09-19
PCT/US1996/014742 WO1997010865A1 (en) 1995-09-19 1996-09-12 Medication delivery pen with cap actuated dose delivery clutch

Publications (2)

Publication Number Publication Date
CA2232005A1 CA2232005A1 (en) 1997-03-27
CA2232005C true CA2232005C (en) 2001-11-20

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US (1) US5674204A (en)
EP (1) EP0861101B1 (en)
JP (1) JP3824650B2 (en)
AT (1) ATE234648T1 (en)
CA (1) CA2232005C (en)
DE (1) DE69626839T2 (en)
DK (1) DK0861101T3 (en)
ES (1) ES2195009T3 (en)
PT (1) PT861101E (en)
WO (1) WO1997010865A1 (en)

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DE69626839T2 (en) 2004-03-04
EP0861101A1 (en) 1998-09-02
CA2232005A1 (en) 1997-03-27
ATE234648T1 (en) 2003-04-15
JPH11512332A (en) 1999-10-26
WO1997010865A1 (en) 1997-03-27
US5674204A (en) 1997-10-07
DK0861101T3 (en) 2003-04-22
DE69626839D1 (en) 2003-04-24
ES2195009T3 (en) 2003-12-01
JP3824650B2 (en) 2006-09-20
EP0861101B1 (en) 2003-03-19
PT861101E (en) 2003-06-30

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