CA2231868C - Pen injector with cartridge loading mechanism - Google Patents

Pen injector with cartridge loading mechanism Download PDF

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Publication number
CA2231868C
CA2231868C CA002231868A CA2231868A CA2231868C CA 2231868 C CA2231868 C CA 2231868C CA 002231868 A CA002231868 A CA 002231868A CA 2231868 A CA2231868 A CA 2231868A CA 2231868 C CA2231868 C CA 2231868C
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CA
Canada
Prior art keywords
lead screw
cartridge holder
pen body
body assembly
assembly
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
CA002231868A
Other languages
French (fr)
Other versions
CA2231868A1 (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
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Filing date
Publication date
Application filed by Becton Dickinson and Co filed Critical Becton Dickinson and Co
Publication of CA2231868A1 publication Critical patent/CA2231868A1/en
Application granted granted Critical
Publication of CA2231868C publication Critical patent/CA2231868C/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
    • A61M5/3146—Priming, e.g. purging, reducing backlash or clearance
    • 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
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • 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 holder assembly, a pen body assembly and a cap. The reusable pen body assembly includes an improved loading and priming mechanism that allows the user to easily load a new cartridge and prime the pen without having to manually manipulate the pen's lead screw and related driving components.

Description

W O 97/10864 PCT~US96/14653 PEN INJECTOR WITH CARTRIDGE LOADING MECHANISM

BAC K GR Oln~nD OF I~IE nN~ENTIO N

o 1. Field ofthe Invention The subject invention relates to an improved cartridge loading and priming m.och~nicm for a medir~tion delivery pen having a cartridge holder assembly and a pen body assembly removably mounted to the cartridge holder assembly for delivering 5 s,o1~ct~rl doses of m~1ic~ti~n.
2. Des~ of Related Art Hypodermic syringes are used to deliver selected doses of medication to 20 p~tiP.nfC 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 ~lo~ al 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 cu~ nir~ting with the chamber.
2s A needle cannula is mounted to the distal end of the prior art syringe barrel, such that the lumen of the needle c~nnnl~ comm--nir~trs 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 ç~nn~ and into the chamber. Movement of the plunger in aproximal-to-distal direction urges fluid from the chamber and through the lumen of the needle c~nnll~zl s l~eAi~ti-~n to be injected with the prior art hypodermic syringe often is stored in a vial having a pierceable elastomeric seal and accessed by piercing the elastomeric seal with the meedle t,~nn~ A s~l~,cte11 dose of the me~lic~tion may be drawn into the chamber of the syringe barrel by moving the plunger a selected distance in a ~lu~-inlal direction. The needle ~~nn~ is withdrawn from the vial, and the medication is injected into a patient by moving the plunger in a distal direction.

Some m~lic~tion, such as insulin is self-~-lmini~tered. The typical di~hetes patient will require injections of insulin several times during the course of the day. The required dose of insulin will vary from patient to patient, and for each patient may vary ls during the course of the day and from day to day. Each diabetes patient will establish a regimen that is a~lupliate for his or her own mefli~,~l con~lifion and for his or her lifestyle. The regimen typically inr~JI~e5 some culllbl~la~-on of a slow or m~i~lm acting insulin and a faster acting insulin. Each of these regim~n~ may require the ~ hetes patient to periodically self-~-imini~ter insulin in public locations, such as places of employment or ~e.~ c. The required manipulation of the standard prior art hypodermic syringe and vial can be inconvenient and til..h~ ;..g in these public en~ull~

M~Aic~tion delivery pens have been developed to l~lcilitzlt~ the self-2s a-lmini~tration of medication. One prior art medication delivery pen includes a vial holder into which a vial of insulin or other medication may be received. The vial PCT~US96/14653 holder is an elongate generally tubular structure with p,oxil-~al and distal ends. The distal end of the prior art vial holder includes mounting means for e~g~ging a double-ended needle ç~nnul~ The l~r~ul-al end also in~lurles mounting means for ~,ng~ging a driver and dose setting a~psldlus as explained further below. A disposable vial for use s with the prior art vial holder inclllcles a distal end having a pierceable elastomeric seal that can be pierced by one end of a double-ended needle ç~nn~ The proximal end of this prior art vial inclll.les a plunger slidably disposed in fluid tight engagement with the cylindrical wall of the vial. This prior art me~1ir,~ti~)n delivery pen is used by inserting the vial of meAit~tion into the vial holder. A prior art pen body then is 10 conn~--cte~ to the plu~illlal end of the vial holder. The pen body inrllldes a dose setting a,u~ald~us for ~esign~ting a dose of meAi~tion tO be delivered by the pen and a driving apparatus for urging the plunger of the vial distally for a tli~t~n~e corresponding to the selected dose.

lS The user of the pen mounts a prior art double-ended needle c~nm~l~ to the distal end of the vial holder such that the p~u~ullal point of the needle c~nm-l~ pierces the elastomeric seal on the vial. The patient then selects a dose and up~,~dLes the pen to urge the plunger distally to deliver the se1~octt-A dose. The dose st~1octing a~alus returns to zero upon injection of the s~le~t~ dose with this prior art mPAi~tiondelivery pen. The patient then removes and discards the needle c~nmll~, and keeps the prior art meAic~tion delivery pen in a convenient location for the next requiredmeAi~tion ~rlmini~tr~tion, The meAic~ti~n in the vial will become exh~nst~A after several such ~lmini~trations of meAic~tinn. The patient then sclldlàles the vial 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 rP~c~emhled and used as explained above.
W O 97/10864 PCT~US96/14653 The above described reusable medication delivery pen is effective and much more convenient for self-~-lminict~tion of merlir~tion than the typical hypodermic syringe and sep~.,.l~ m~ir~ti~ln vial. However, the ~iic~ccemhly of the pen to remove s empty me lic~ti~n vials and to insert new ones is an inconvenience. As a result, disposable pens have been developed. The prior art disposable me~ic~tilln delivery pen inrl~ s a vial of insulin or other such m~lir~tinn perm~nPntly encapsulated therein.
The patient need merely connect a double-ended needle c~nm-l~ to the disposable pen for each ~ ion of mr~1iç~tion. The prior art disposable pen can be discarded o when the supply of me~iir~tinn perm~n-ontly encapsulated therein has been exh~-lste~

Disposable meAic~tion delivery pens offer certain conve~ once~c to the patient who is required to self-~Aminictçr m~lir~tion. However, the dose selecting and driving mech~nicmc of prior art medication delivery pens are fairly complex devices and costly S to m~nnf~ctllre. Hence, a ~u~u.lial cost penalty is associated with the convenience of using a disposable medication delivery pen.

Another problem with the above-described me~iir~ti-~n delivery pens is in loading and priming the pens. These pens usually utilize a lead screw and m~trhing nut 20 cr,mhin~ti-)n that tr~nC1~te a rotary dose setting motion into a linear lead screw motion required to expel me~lir~tinn from the pen or cartridge. In such a m~o~h~nicm, the nut is allowed to rotate during medication delivery while rotation of the lead screw is prevented by means of a rigidly mounted ring with tabs ç~ctenAing into the lead screw.
Theltf~"t;, as the nut turns the pre-selected amount, threads on the nut and lead screw ~s cause the lead screw to move axially to deliver the medication. Then, when the W O 97/10864 PCT~US96/14653 cartridge is empty and must be replaced, the fully extended lead screw must be m~n-l~lly rotated and retumed to a starting position to receive a new cartridge.However, manual rotation of the lead screw is very difficult since the tabbed ring is int~n-ieA to prevent rotation of the lead screw.

SUMMARY OF T~IE lNVENTION

It is an objective of the present invention to overcome the problem with moving the lead screw back into the pen during cartridge loading found in prior art pens by 0 providing a medication delivery pen having an improved cartridge loading and priming mechanism that allows a patient to easily load and prime the pen. The present invention provides a pen with a lead screw that is easily slid back into the pen during cartridge loading and thereby eli...i.~ s the need for a patient to manipulate an anti-rotation tabbed ring. In the present invention the lead screw does not stop sliding until 5 the cartridge holder assembly has been fully threaded onto the pen housing and, therefore, provides aulolll,LLic ~ ; of the pen during the threading operation and causes the lead screw to au~ lly engage with a drive mecl~

In particular, the meAi-~ti~ n delivery pen of the present invention includes a 20 m~Ai~ti-)n cartridge holder assembly that is selectively eng;~g~hle with and eng~ge~hle from a pen body assembly. In particular, the m~1i-~tion delivery pen in~ s means for allowing the lead screw in the meAic~til~n delivery pen to automatically and easily slide into and prime the me~lic~ti~ln delivery pen as the cartridge assembly approaches the pen body assembly, when the lead screw is in 2s contact with the plunger in the cartridge. The medication pen also includes means for eng~ging the lead screw to the cartridge holder assembly as the cartridge is being W O 97/10864 PCT~US96/146~3 threaded to the pen body assembly and means for en~ging the lead screw to the drive me~.h~ni~m when the cartridge holder assembly has been fully threaded to the pen body assembly.

These and other ~pects, r~ul~s and advantages of the present invention will become al~p~en~ from the following ~Iot~il~i description taken in conjunction with the accon,panyiLlg drawings.

DESCRIPTION OF THE PR~WINGS

Fig. 1 is a perspective view of the me~ tit)n delivery pen of the subject invention;

Fig. 2 is a longitllflin~l cross-sectional view of an u.l~cel~bled me~ rion 1~ delivery pen shown in Fig. 1 along lines 2-2;

Fig. 3 is a longihl-lin~l cross-sectional view of an ~ mblPA m~Air~ti~n delivelypen shown in Fig. 2;

Fig. 4 is a exploded perspective view of the myli~tion delivery pen shown in Fig. l; and Fig. S is a cross-sectional view of the m~lic~tion delivery pen shown in Fig. 2 along lines 5-5.
2s DETArr Fn DESCRIPIION

W O 97/10864 PCT~US96/14653 A mP~ tion delivery pen in accordance with the subject invention is identified generally by the numeral 10 in Figs. 1-4. ~çAit~ion delivery pen 10, as shown inFigs. 1-4, inr~ çs a reusable pen body assembly 100, a cap 200, a cartridge holder s assembly 300, and a needle c~nnlll~ assembly 500. Cartridge holder assembly 300 inclll-~çs opposed plu~llal and distal ends 301 and 302, respectively. r~ al end301 of cartridge holder assembly 300 is ~limen~ioned and configured to threadedly engage pen body assembly 100, as expl~inPd further herein. Distal end 302 of cartridge holder assembly 300 is configured to securely but releasably engage needle o c~nn~ assembly 500.

The l -cre-l~,d embodiment of reusable pen body assembly 100 is illustrated in detail in Figs. 2-4. It is undPrstnod, however, that variations from this ~ cd embodiment may be provided, and are considered to be within the scope of the subject S invention. Reusable pen body assembly 100 includes a generally cylindrical housing 101 having opposed ~ lal and distal ends 102 and 103. An ar~ay of çxtP~
threads 105 extends proximally from distal end 103 for threaded engagement with threads 303 in ~l~llal end 301 of cartridge holder assembly 300. Portions of housing 101 ~ çnt distal end 103 are ch~ tç~i7P~ by an array of clutch teeth (not shown)molded t_erein. ~,~-al end 102 of ho~l~ing 101 is ch~ Pcl by a cut-out 106 formed therein for 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 longitudinally e~tenlling PCTnUS96/14653 splines 113. Proximal end 111 of nut 110 is ch~r~cterized by a plulality of longit~-llin~lly e~cten~lin~ resilient fingers 114 with enlarged ends that enable snap engagement of nut 110 into other portions of pen body assembly 100 as e~lailled further herein. Distal end 112 of nut 110 is radially enlarged to limit axial movement s of nut 110 into distal end 103 of housing 101. Thus, nut 110 is axially con~train within holl~ing 101. However, the ~imPn~inns and confi~tions of nut 110 and housing 101 permit free relative rotation the~;belween.

Pen body assembly 100 further inl-hl(1es a clutch ~c~mhly having a ~,u~.lal 0 clutch 141, a distal clutch 143 and an annular spring 142 biasingly en~l therebetween. Proximal and distal clutches 141 and 143 are both configured for non-rotatable çng~gemPnt over splines 113 of nut 110. Distal clutch 143 includes an a}Tay of distally facing saw teeth (not shown) ~limen~ioned, disposed and configured for engagement with the teeth (not shown) on interior surface 108 of holl~ing 101, such that distal clutch 143 can rotate only in one direction relative to housing 101. rr~"al clutch 141 in~ p~ an array of ~ ~llally facing teeth (not shown) which are also configured for unidirectional rotation as explained further herein.

Pen body assembly 100 further in-1-lriPs a drive mP,rh~ni~m having a generally cylin-lri~l driver 450 with opposed ~,u~,.al 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 snap fit over the enlarged ends of resilient fingers 114 at IJlU~dilllal end 111 of nut 110. This snap fit engagement prevents axial movement between nut 110and driver 450, but permits free relative rotational movement within housing 101.
Distal end 452 of driver 450 is also ch~ tPrized by an array of saw teeth (not shown) that engage with the saw teeth on proximal clutch 141. Outer surface regions of driver W O 97/10864 PCT~US96/14653 450 are characterized by splines 454 e~ct~n-ling radially outwardly thereon and along a .lb~ 1 portion of the length of driver 450.

Pen body assembly 100 further in~,hl(le,s a dose knob 400 which is a hollow 5generally cylin~ri~,~l structure having opposed proximal and distal ends 401 and 402 and opposed irmer and outer sllrf~le-es. The inner surface is ch~r~c.t~,rized bylon~ihlrlin~lly e~ten-ling grooves 405 which are disposed and dimensioned for .n~gçment 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 0P,xt-~.ntling grooves 405 in dose knob 400 engage splines 454 of driver 450 to prevent relative rotation therebetween, but l.el.niLli lg relative axial movement. The outer surface of dose knob 400 is rh~r~,t~,ri7~1 by a helical groove 403 with dosage indicia to define dose amounts corresponding to dirre.t;..l positions along helical groove 403.
I~o~llal end 401 of dose knob 400 is ch~r?~cterized by a gnarled exterior surface to f~.ilit~t~, m~nip~ tinn for setting a se~ ct~-A dose having an actuator button 407 snapped therein to permit relative rotation ~ b~lween.

Insert 150 is snapped into e,n~gP-m~-nt with cut-out 106 in the proximal end 102of hnu~ing 101. Insert 150 in~ es a window 151 thel, llu~ugh and button 152 on an 20 interior face that is ~lime,n~ioned and disposed to engage with helical groove 403 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.

2sPen body assembly 100 includes a lead screw 120 with opposed plv~i---al and distal ends 121 and 122 and an array of external threads 123. External threads 123 are g characterized, however, by a pair of opposed axially e7~t~n-1ing grooves 124 which extend from an enlarged head 125 at distal end 122 subst~nti~lly to the proximal end 121. Threads 123 are threadably engaged in nut 110, such that proximal end 121 of lead screw 120 is within housing 101 and distal end 122 projects distally beyondhousing 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 includes an anti-rotation ring 160, shown in Figs. 2-5, having a pair of tabs 161 extending therein and splines 162 on its distal o 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 move relative to anti-rotation tabs 161, but is prevented from rotating relative to anti-rotation tabs 161.

Pen body assembly 100 is assembled by placing nut 110 into housing 101 from distal end 103. Clutch assembly 141,142 and 143 then is mounted over splines 113 on nut 110. Driver 450 is then inserted into ~lu~ al end 102 of housing 101, and isurged s~ ently in a distal direction for snap fit engagement with nut 110. In this snapped engagement, the saw teeth of distal clutch 143 will be secured in engagement with the teeth in of housing 101, and the saw teeth of ~lu~l~al clutch 141 will be engaged with the saw teeth at distal end 452 of driver 450. Spring 142 will m~inf~in co~ se~r,ted pr~s;~ult; b~lw~n these hlle~ ~ed saw teeth. Insert 150 then is positioned over dose knob 400 such that button 152 of insert 150 is engaged in the helical groove 403 in dose knob 400. The temporarily assembled insert 150 and dose knob 400 then are urged into housing 101. Lead screw 120 then is threaded into nut 110, and actuator button 407 is snapped into engagement with proximal end 401 of W O 97/10864 . PCT~US96/14653 dose knob 400. Finally, anti-rotation ring 160 is slid onto lead screw 120 and a,e~ ,g ring 163 on ring 160 is rotatably attached to a receiving ring 165 at distal end 103 of pen housing 101.
. . .
Cartridge holder assembly 300, shown in detail in Figs. 2 and 3, in~ lries a mol-l~l housing 304 which extends from proximal end 301 to distal end 302 of cartridge holder assembly 300. ~ou~ing 304 includes a mounting cavity 305 e~ct~n~1ing inwardly from proximal end 301. Mo~lnting cavity 305 is ch~ ;,eA by an array of int~rn~l threads 303 for threaded engagement with external threads lOS on distal end o 103 of housing 101. A set of splines 306 are located in ~ruxi~l~al end 301 of cartridge holder assembly 300 to receive splines 162 on anti-rotation ring 160 when cartridge holder assembly 300 is threaded onto housing 101 to prevent cartridge holder assembly 300 from rotating with respect to lead screw 120 but continue to rotate with respect to pen housing 101. However, when pen 10 is fully assembled. splines 162 are fully lS engaged with splines 306 so that lead screw 120 is then eng~ge~ with the ,~ io;g drive mech~ni~m in the pen and ready for dose setting and ~ r~,n~inp operations.

Cartridge holder ~ ombly 300, further inch~des a m~Ai(~fic~n cartridge 350 securely retained in housing 304 between proximal end 301 and distal end 302.
M~Air~tion car~idge 350 int~hl-ies an open ~l~,~.,al end 351 and a distal end 352 having a pierceable e!~tomt-,ric seal 353 securely mounted thereto. A cap 354 extends bt;~ween housing 304 and cartridge 350 for securely and ~ nf~..lly holding meAi~ti~n cartridge 350 in housing 304. A plunger 355 is disposed in sliding fluid tight engagement in cartridge 350. As shown in Fig. 3, plunger 355 is disposed in 2~ prirned contact with plunger 355 of medication cartridge 350 when fully threaded to cartridge holder assembly 300. Portions of cartridge 350 between plunger 355 and seal PCT~US96/14653 353 are filled with a merlic~tinn 356, such as insulin.

Needle c~nm~l~ assembly 500 incl~ldes a double ended needle cannula 501 having opposed l,l~llal and distal points 502 and 503, l~ e~ rely, and a lumen s ext~n-ling axially therebetween. A mounting hub 504 is engaged on needle cannula 501 and is threadably engageable with cap 354 of cartridge holder assembly 300. The relative location of mounting hub 504 ensures that proximal point 502 of needle cannula 501 wil1 pierce seal 353 when mounting hub 504 is engaged with cap 354.
Needle c~nn-ll~ assembly 500 further inrlnc~es a shield 600 removably mount~A thereon o for protecting against accidental needle sticks until immeAi~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 m~-Ai~ tion 356 sllffls~ient for ~lmini~t~tinn of S seve~al doses. After e~h~llsticlrl of the medication 356, cartridge holder assembly 300 will be threadedly rlicpn~ed from pen body assembly 100 and discarded. A new cartridge holder assembly 300 may then be mounted to the reusable pen body ~c.ceml~ly 100.

To effect the mounting of a new cartridge holder ~c.cemhly 300 to the reusable 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. Assembly continues by merely exerting axial forces on actuator button 407 and on cartridge holder assembly 300 Additionally, friction between plunger 355 and cartridge 350 and fluid forces exerted by medication 356 and seal 353 Will prevent axial advancement of lead screw 120 beyond the position depicted in Fig. 3 during W O 97/10864 PCT~US96/146S3 assembly. Additionally, the splined engagement of distal clutch 143 with nut 110 and the engagement of the teeth on distal clutch 143 with the collc~l~onding teeth in housing 101 prevent in(lepen-lPnt rotation of nut 110 with respect to housing 101, during this initial mounting of reusable pen body assembly 100 with a new cartridge holder assembly 300. Therefore, axial forces exerted on actuator button 407 will cause housing 101 to rotate and advance towards cartridge holder assembly 300 as nut 110 rotates on threads 123 of lead screw 120.

After snMçient axial adv~nremPnt7 threads 105 at distal end 103 of pen body o housing 101 will engage internal threads 303 at proximal end 301 of cartridge holder assembly 300. As noted above, external 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 actuator button 407 will cause the ~imlllt~nP,ous threaded adv~nr,ement of housing 101 along lead screw 120 and into cavity 305 at ~ imal end 301 o~cartridge holder assembly 300. Rer~llse of the identical pitches, lead screw 120 will move p~ ally relative to pen body holl~ing 101, while pen body housing 101 and cartridge holder assembly 300 are approaching their fully seated and threaded condition. When fully seated and threaded, lead screw 120 is fully P,n~ge~ to the drive merh~nicm and can be driven by the drive mech~nicm when me ii~tion (li~ h-giS desired.

The assembled reusable pen body assembly 100 and cartridge holder ~ccemhly 300 may be stored until a selected dose of medication is required. Just prior to use, a needle c~nnnl~ assembly 500 may be threadedly engaged to distal end 302 of cartridge holder assembly 300. This threaded engagement will cause proximal tip 502 of needle cannula 501 to pierce seal 353 and provide commnnic~tion with medication 356.

W O 97/10864 PCT~US96/14653 Shield 600 may then be removed.

A desired dose of medication 356 is then set by rotating dose knob 400 until indicia collc~onding to the desired dose appears in window 151 of insert 150. The s engagement of button 152 on insert 150 in helical groove 403 in dose knob 400 will cause a threaded retraction of dose knob 400 relative to housing 101 of reusable pen body assembly 100. This threaded ret~cticn of dose knob 400 will cause a ~imnlt~nPous rotation of driver 450 splined thereto. However, nut 110 will not rotate because the saw teeth on distal clutch 143 and the saw teeth on interior portions of o 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 proximal clutch 141 and provide an audible click for each unit of medication in the selected dose. This is helpful for visually i~ ail~,d p~tiPnt~ who may be required to set doses and a~ i"i~er insulin or other medication to themselves. Annular spring 142 collLlil~ules to the engagement that provides these audible clickin~ sounds.

When the desired dose is set, injection is achieved by merely pushing on actuator button 407. This causes dose knob 400 to turn about helix 403 relative to pen body housing 101, and driver 450 rotates through the same number of degrees. This rotation is opposite to the rotation g~ d by the dose setting procedure, and therot.tion~l freedom of the clutch assembly 140 is reversed. Thus, as driver 450 turns the previously clicking ~)lo~ llal clutch 141 is locked to and turns with driver 450.
This driving movement of proximal clutch 141 causes a corresponding rotational 2s 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 clicking in~ ti-ln during injection of medication.

Rotation of lead screw 120 is prevented by splines 306 unitarily molded in cartridge holder assembly 300 mating with splines 162 on anti-rotation ring 160 s engaged with lead screw 120 and causes lead screw 120 to be engaged with the drive mech~ni~m. Th~,role, as nut 110 rotates under the driving action of l lu~ al clutch 141 and driver 450, lead screw 120 will be advanced axially into cartridge holder assembly 300. This axial adv~nremer t of lead screw 120 causes distal end 122 to urge plunger 355 distally into cartridge 350, and hence causes meAir~tion 356 to be injected 0 through needle r~nn~ 501. Injection will be tel.. i.. ~3lr~ when ~lu~dL~I~al end 401 of dose knob 400 engages proximal end 102 of pen body housing 101.

Upon completion of the injection, needle r~nn-ll~ assembly 500 may be eng7~ed from cartridge holder assembly 300 and safely discarded. Cap 200 may be 5mounted over cartridge holder assembly 300, and pen 10 may be stored or carried in a convenient location until the next dose of me~iic~ti~ln is required. A subsequ~nt dose of meAi~ti~)n will be set in exactly the manner as described above. However, for such a 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 of20m~Aic~tinn 356 has been used. Cartridge holder assembly 300 may then be threadedly tong~ged from pen body assembly lO0, and slidably scp~r~teA from lead screw 120.The s~lualalc;d cartridge holder assembly may then be discarded and replaced as described above.

2sWhile the invention has been described with respect to a ~l~rellc;d embodiment, it is apparent that various changes can be made without departing from the scope of the W O 97/10864 PCT~US96/146~3 invention as defined by the appended claims. In particular~ the reusable pen body assembly may have other driving and/or clutch mech~nicm~ Additionally, dir~.~l.Lmeans 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 5 cartridge holder assembly may be provided. These various optional constructions will be ~p~e.lL to those skilled in the art after having read the subject disclosure.

Claims (9)

Claims:
1. A medication delivery pen comprising:
a cartridge holder assembly for holding a cartridge having a plunger, said cartridge holder assembly having a plurality of threads at a proximal end; and a pen body assembly releasably mountable on said cartridge holder assembly of said medication delivery pen for moving said plunger within said cartridge, said pen body assembly comprising:
a plurality of threads at a distal end for threading with said plurality of threads in said cartridge holder assembly;
a lead screw extending from the distal end for engaging the plunger in the cartridge in said cartridge holder;
means in said pen body assembly for driving said lead screw into said cartridge to move the plunger in the distal direction;
means in said pen body assembly for disengaging said driving means from said lead screw to permit said lead screw to automatically and easily retract into said pen body assembly as said pen body assembly approaches and is being threaded to said cartridge holder assembly; and means in said pen body assembly for engaging said driving means to said lead screw to prime said medication delivery pen, when said pen body assembly is fully threaded onto said cartridge holder assembly, wherein said means for disengaging and means for engaging include:
an anti-rotation ring slidably mounted on said lead screw to prevent said lead screw from rotating with respect thereto, said anti-rotation ring having a spline extending in the distal direction into said cartridge holder assembly; and a spline located within said cartridge holder assembly for mating with said spline on said anti-rotation ring to prevent said lead screw from rotating with respect to said cartridge holder assembly and engage said lead screw to said driving means, when said pen body assembly is fully threaded onto said cartridge holder assembly.
2. A medication delivery pen according to claim 1, wherein said lead screw includes a longitudinal groove and said anti-rotation ring includes a tab that is received in said groove to prevent said lead screw from rotating with respect to said anti-rotation ring.
3. The medication delivery pen of claim 1, wherein said cartridge holder assembly further comprises a housing unitarily molded from a plastic material with said spline being a unitary portion of said housing.
4. A medication delivery pen according to claim 1, wherein:
said plurality of threads in said pen body assembly are dimensioned and have a pitch for threaded engagement with said plurality of threads at the proximal end of said cartridge holder assembly; and said lead screw further comprises a proximal end disposed in said pen body assembly with an array of threads extending between the proximal end and the distal end of said lead screw and having a pitch substantially equal to said pitch of said plurality of threads in said pen body assembly.
5. The medication delivery pen of claim 1, wherein said pen body assembly further comprises dose setting means in said pen body assembly for defining specified distances of travel for said lead screw corresponding to selected doses of medication to be delivered.
6. The medication delivery pen of claim 1, further comprising a needle cannula assembly that is selectively engageable and disengageable from the distal end of said cartridge holder assembly.
7. A medication delivery pen comprising:
a cartridge holder assembly for holding a cartridge having a plunger, said cartridge holder assembly having a plurality of threads at a proximal end; and a pen body assembly releasably mountable on said cartridge holder assembly of said medication delivery pen for moving said plunger within said cartridge, said pen body assembly comprising:
a plurality of threads at a distal end for threading with said plurality of threads in said cartridge holder assembly;
a lead screw extending from the distal end for engaging the plunger in the cartridge in said cartridge holder;
means in said pen body assembly for driving said lead screw into said cartridge to move the plunger in the distal direction;
means in said pen body assembly for disengaging said driving means from said lead screw to permit said lead screw to automatically and easily retract into said pen body assembly as said pen body assembly approaches and is being threaded to said cartridge holder assembly; and means in said pen body assembly for engaging said driving means to said lead screw to prime said medication delivery pen, when said pen body assembly is fully threaded onto said cartridge holder assembly, wherein said means for disengaging and means for engaging include:
an anti-rotation ring slidably mounted on said lead screw to prevent said lead screw from rotating with respect thereto, said anti-rotation ring having a plurality of splines extending in the distal direction into said cartridge holder assembly;
and a plurality of splines located within said cartridge holder assembly for mating with said plurality of splines on said anti-rotation ring to prevent said lead screw from rotating with respect to said cartridge holder assembly and engage said lead screw to said driving means, when said pen body assembly is fully threaded onto said cartridge holder assembly.
8. A medication delivery pen comprising:
a medication-containing cartridge holder 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 said cartridge at a location distally of said array of threads; and a pen body assembly releasably mountable on said medication-containing cartridge holder assembly of said medication delivery pen for moving said plunger within said cartridge, said pen body assembly having:
a housing surrounding said pen body assembly and having 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 holder 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 having a pitch substantially equal to said pitch of said array of threads at said distal end of said pen body assembly, driver means in said pen body assembly for moving said lead screw distally into said pen body assembly by preselected amounts, dose setting means in said pen body assembly 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 preselected amount corresponding to a selected dose, and means in said pen body assembly for engaging said lead screw and said driver means and preventing said lead screw from moving in a proximal direction into said pen body assembly, when said pen body assembly is fully threaded onto said medication-containing cartridge holder assembly.
9. A medication delivery pen according to claim 8, wherein said means for engaging said lead screw and said driver means and preventing said lead screw from moving in a proximal direction into said pen body assembly include:
an anti-rotation ring slidably mounted on said lead screw to prevent said lead screw from rotating with respect thereto, said anti-rotation ring having a spline extending in the distal direction into said medication-containing cartridge holder assembly; and a spline located within said medication-containing cartridge holder assembly for mating with said spline on said anti-rotation ring to prevent said lead screw from rotating with respect to said medication-containing cartridge holder assembly and engage said lead screw to said driver means, when said pen body assembly is fully threaded onto said medication-containing cartridge holder assembly.
CA002231868A 1995-09-19 1996-09-12 Pen injector with cartridge loading mechanism Expired - Fee Related CA2231868C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US08/530,527 1995-09-19
US08/530,527 US5688251A (en) 1995-09-19 1995-09-19 Cartridge loading and priming mechanism for a pen injector
PCT/US1996/014653 WO1997010864A1 (en) 1995-09-19 1996-09-12 Pen injector with cartridge loading mechanism

Publications (2)

Publication Number Publication Date
CA2231868A1 CA2231868A1 (en) 1997-03-27
CA2231868C true CA2231868C (en) 2002-06-11

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ID=24113953

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002231868A Expired - Fee Related CA2231868C (en) 1995-09-19 1996-09-12 Pen injector with cartridge loading mechanism

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US (1) US5688251A (en)
EP (1) EP0862473B1 (en)
JP (1) JP3824649B2 (en)
AT (1) ATE240757T1 (en)
CA (1) CA2231868C (en)
DE (1) DE69628322T2 (en)
ES (1) ES2199296T3 (en)
WO (1) WO1997010864A1 (en)

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