CA2244960A1

CA2244960A1 - Pen needle

Info

Publication number: CA2244960A1
Application number: CA002244960A
Authority: CA
Inventors: Scott Reed; Matthew Murray; William J. Allen; Jeffrey A. Stein; Robert E. West; Michael A. Dibiasi; Tuan V. Nguyen
Original assignee: Becton Dickinson and Co
Current assignee: Becton Dickinson and Co
Priority date: 1997-09-12
Filing date: 1998-08-12
Publication date: 1999-03-12
Also published as: US5829589A; JP4339429B2; EP0903158B1; EP0903155A3; EP0903158A2; DE69805720T2; JP4890579B2; JPH11164889A; DE69805584D1; CA2244759A1; JP4331287B2; EP0903155B1; DE69805720D1; DE69805584T2; JPH11146914A; CA2244759C; JP2009131685A; EP0903155A2; EP0903158A3

Abstract

A pen needle being of a type that is forced fit into an adaptor on the pen usingthreads on the pen needle and corresponding threads in a cavity of a pen needle magazine dispenser designed to be received and carried in a cap of a medication delivery pen. The dispenser having a cover rotatably mounted on a circular shaped container to cover a plurality of cavities, wherein each cavity is dimensioned to receive one of the pen needles. The cover includes a slot that is rotated into alignment with one of the cavities in the container to provide the user with access to one unused pen needle and thereby permit the pen needle to be mounted on the pen. After use the used pen needle is returned to the cavity and the cover is rotated until the slot is aligned with another cavity containing the next unused pen needle to be used during the next injection.

Description

PEN NEEDLE

BACKGROUND OF I~IE INVEN I~ON

1. Field of the Invention The subject invention relates to a pen needle dispenser for a new pen needle 5 and, more particularly, to pen needle magazine dispenser that holds and dispenses sterile pen needles for medication delivery pens and that safely stores the needles after use.

2. Description of Related Art .
Hypodermic syringes are used to deliver selected doses of medication to p~ti.onts. I'he p~ior art hypodermic syringe inc~ 1es a syringe barrel having opposed al and dis~l ends. A cylin<lric~l chamber wall çxtPntls between the ends and defines a fluid receiving chamber. The pl~ al end of the prior art syringe barrel is 25 ~ub~ 11y open and receives a plunger in sliding fluid tight engagement. The distal end of the prior art syringe barrel includes a passage co~ ting with the chamber.

A needle c~nnnl~ is mounted to the distal end of the prior art syringe barrel, such that the lumen of the needle c~nn~lq communic~tes with the pas~ge and the ch~ of the syringe barrel. Movement of the plunger in a plV~-illlal direction draws fluid through the lumen of the needle c~nn~llq and into the chqmber. Movement of the plunger in a s ~ to distal direction urges fluid from the c1-~inbel and through the lumen of the needle c~nnul~, n to be injeCt~ with the prior art hypodermic syringe often is stored in a vial having a pic.~ble elastomeric seal. ~ff~ tion in the prior art vial iso ~cce~ssd by piercing the elastomeric seal with the needle c~nn~ A s~t~l dose of the m~die~tion is drawn into the chamber of the syringe barrel by moving the plunger a s~ ted di~nce in a pr~ al direction. The needle c~nn~ iS withdrawn from the vial, and the m~lis~tion is inje~ed into a patient by moving tbe plunger in a distal direction.

Some me~1i~tion, such as insulin is self-~ ;n~ The typical di~ s patient will Iequire injecti~m~ of insulin several times during the course of-the day. The r~uuod dose of insulin will vary from patient to patient, and for each pa~ient may vary during the course of the day and from day to day. Each ~ s patient will establish a that is appropri~e for his or her own medical cnnt1~ u~ and for his or her yle. The l~,l;hllo~ typically in-~ud~s some co"~ ation of a slow or .~.~;..~.- acting insulin and a faster acting insulin Each of these ~ may require the di~s patient to pe~ lly self~ t~ insulin in public locations, such as places of employment or l~b~ . The ~ u-l~,d nnqn~ulation of the ;,~d~nl prior art 25 LY~OdP~In;C syringe and vial can be incon~ and e-~ ..,c~;~ in these public enV~n---Pn~

M~lic~tion delivery pens have been developed to f~ilit~te the self-~~...;n;~ on of rne~lic~~ion. A prior art medication delivery pen is identified generally by the n~Jm~,~l 1 in Fig. I. Pen 1 COIllainS a ca tridge with sl~ffi~i~nt s rn~lic~tion for several doses. The prior art cartridge has opposed pNj~"al and distal ends. The distal end is closed by a p--~ble and resealable rubber septum id~.niri~1 by the nllmP.~I 2 in Fig. 1. The ~ al end receives a st~er in sliding fluid-tight engagement. The prior art calL,id~ is disposed in an elon~te pen-like body 4 with a p~ lal end (not shown) and an opposed distal end 6. The p~,al end of the pen 0 body in~ des a plunger for selectively driving the stopper of the cartridge in the distal direction and a dose setting m~l-~ni~ for d~le~ g the ~ n~e thr~ugh which the plunger and stopper can move. Distal end 6 of pen body 4 inclvdes an array of threads 8 for threaded engagement with a pen needle assembly 90. Pen needle assembly 90 incl~ldes a needle c~nn~ 91 with opposed proximal and distal points 92 and 93 and a threaded mounting skirt 94 which surrounds the plo~ulllal tip 92. Mounting skirt 94 is threadably engageable with threads 8 on distal end 6 of pen body 4. A safety shield 95 is releasably e~ ed over distal point 93 and portions of mounting skirt 94 to p~,nl aGCi'1ent~1 needle sticks.

A person who must per~ cqlly inject doses of medication will carry a medication delivery pen 1 and a supply of pen needle ~ l;r~ 90, Each pen needle --hl~ 90 has its needle c~nn~ 91 safely and sterility sealed in its own shield 95, and is r~cessed ;~ cly pdor to a~ '; ~g a dose of medication. Pen needle ~Se~ JI~ 90 then is mo~nt~d to distal end 6 of pdor art pen 1. This ulounling causes p o~dl point 92 of needle cqnn~lq 91 to pier~e rubber septum 2 of the calllidg~, to place needle cqr ~lq 91 in Co~ ation with the ..~lic~;o-- in pen 1. Pen 1 then is used to inject the selected dose of me li~tion After completing the injection, needle assembly 90 is separated from pen l and is discarded. Pen l may be used repeatedly in this l.l~me until the m~ic~tion is eYh~1~sted Such prior art pens offer many conv~~ s and Pffl~ion~ios However, the storage of unused needles and the final s disposal of used needles hus p~es~,.led problems. In particular, supplies of new needles often are loosely scattered in the bottom of purses or briefcases, and used needles are often disl)osed of unsafely.

SUMMARY OF T~IE INVI~TION

The subject invention relates to a storing and &~ sh,g a ~ alus for needle ~m~ o,s used with hypodermic syringes and pler~ably a new type of pen needle that is de~i~1 to attach to an adaptor having conventional threads that mate with threads 8 on medication delivery pens.

The pen needle dis~,~s~r of the present invention in- 1~1des a m~7into. dispenser having a cover rotatably mounted on a co~ r with a plurality of cavities, with each cavity ~lim~n~ion~1 to receive a new type of pen needle assembly. The cover in~ des a slot that is rotated into ~li~ n~.ont with a cavity in the co.~h~;nP.r that co-;1 ;nc an 20 unused pen needle. When the-slot is aligned with such a cavity, the user inserts the adaptor on the medication deLivery pen into the cavity and rotates the pen to mount the unused pe:n needle on the medication del;~ pen. After the injection has been v~ ed, the used pen needle is ~ A to the cavity by il~ ling the used pen needle in the cavity and lO~i~g the pen to detach the pen needle fr~m the ~dd~)lo- on 2s the pen. The user then rotates the cover until the slot in the cover pmvides access to the next cavity co~ ; ug ~ J(I'~" unused pen needle to be used during the next injection.

An object of the present invention is to prevent the pen needle from being reused by having it covered in the pen needle ...~ e ~li~en~,r, In ~d~lition~ once s the cover has been rotated to the next cavity, the pen needle ...ag..,.;,-f fii~;pe,n~er provides means to prevent the cover from rotating back to used pen n~lles, Another object of the present invention is to provide a user with a convenient way to carry, dispose of and keep track of their ~ al pen needle usage. The pen o needle ma~7in~o dispenser is ~esi~ to fit in the cap of the medication delivery pen and contain apred~e....i~ u~-lber of pen needles in le~ e cavities, with each cavity being sealed by a numbered label or sterility me.nbl~le. The numbered labels n~ te how many unused pen needles remain in the pen needle m~p7ine dispenser.

Another object of the present invention is to provide an adaptor that is threaded onto the distal end of conve~ntiQn~l me~ic~ti~n delivery pens so that a new type of pen needle can be used with such conventio~ nedication delivery pens. The new type of pen needle incl~Jdes a base having threads on one end that drive the other end of the base into the adaptor to create a friction fit l~o~n the adaptor and the base. The driving force is ~n~"~t~l by using the adaptor to rotate the pen needle ~ iVe to its cavity and thereby ullllll~ad the pen needle from the cavity and force fit it in to the ady)tor.

These and other ~ , f~lu~s and adv~ of the present invention will 2s bec~!. r, apparent from the following ~P~il~ ;on taken in conju~ l;on with the g dl~willgD.

DESCRIPTION OF THE DRAWINGS

Pig. 1 is an elcrlo~ e view of a prior art pen needle and the distal end of a prior art meAi~ion delivery pen with which the present invention is intended s to be used;

Fig. 2 is an exploded ~.~ e view of a cap on a m~li~ion delivery pen and a pen needle mag~7ine disp~lsel accolding to the present invention;

10Fig. 3 is a perspective view of a pen needle acco~hlg to the present inventionbeing ~ rhed to an adaptor threaded on the distal end of a me ~ tion delivery pen;

Fig. 4 is an exploded perspective view of the pen needle m~7in~ dispenser shown in Fig. 2;

Fig. S is an exploded pe~ e view of the adaptor and pen needle with a par~al cross-~ion~l view of the pen needle ~ ,.;ne A;s,l~n~-.., and Fig. 6 is a~ r exploded view of the adaptor and pen needle acco~ing to the 20present ~nlion.

DETAILED DESCRIPIION

A pen needle .-.~g~,;nf. A;~ Er in acco.~lanoe with the subject invention is 25iA-.11;r~-?A ~n~lly by the ~-lm.o,l~l 10 in Pigs. 2, 3 and 4. Pig. 2 is an exploded ~ e view of a cap 3 on a .~ ' ;OIl delivery pen 1 and a pen needle .. ~g~.;n~

dispenser 10, according to the present invention. Cap 3 includes a clip 5 and an open end 7 rlim~on~ ned to receive pen needle ~ g,.,;..e di~nser 10. Fig. 3 is a perspective view ~ g the operation of inserting an adaptor 50 on distal end 6 ofrm~i~tio~ delivery pen 1 into pen needle mq~ ne ~ . 10 and the rot~tic-n~l 5 motion used to attach a pen needle assembly 100 to adaptor 50.

As shown in the exploded ~.~ e view in Fig. 4, pen needle .~ e ~ ,r 10 in-~ludes a cover 20 and a co.lt~iner 30. Collt;~nfr 30 includes a plurality of cavities 31 about the ci~ulnrelc;llce of collt~ er 30, with each cavity 31 o dim~n~ioned to receive a pen needle assembly 100, described further below. Each pen needle assembly 100 is originally sealed in its l~s~ e cavity 31 by a disc shaped label or sterility barrier 150 that is ~ hed to an upper surface 32 of co~n~iner 30.
Label 150 provides sterility for unused pen needle assemblies 100 coll~h~ed in each cavity 31 and a simple means for the user to identify whether the pen needle assembly S in a particular cavity has been used.

Pen needle ...~ e dispenser 10 is initially loaded with a p,~d~....;~-fA
~ mber of pen needle ~semb1i~s 100 in the plurality of cavities 31, with all of the cavities 31 being sealed by sterility barrier 150 and having a ~ulllb~r 151 lh~o~
co~ )o~ , to each cavity 31. Each llu~l~r 151 or other indicia on label 150 indicates to the user how many unused pen needle ~ 00 remain in pen needle m~7ine ~ 10. Label 150 inclu~les a central op~ g 152 a-l~ugll which cover 20 is ~-~o~ h~1 on CQn~in~or 30 and is scored at the loc~ti~n of each cavity 31 without, of course, arr~g the ult~lily of the seal to allow for controlled bl~ahing when 2s 1~1~tor 50 on medication delivery pen 1 is ~l~sed ~uu~h label 150 when loading pen needle ass~ bl~ 100 on adaptor 50. The controlled breaking of the scored area aUows adaptor S0 on medication delivery pen 1 to be inserted through label 150 to mate with pen needle assembly 100 within cavity 31.

After pen necdle ...~g~ di~ 1, shown in Fig. 4, is loaded with new s needle ~semblies 100 and fully assembled with cover 20 rotatably mounted on co~ f r 30 and label 150 ~t~~hP~l to upper surface 32 over one of cavities 31, cover 20 is rotated with respect to co.~ er 30 to move slot 21 over the first loaded cavity 31. As shown in Fig. 4, co..l ;~-er 30 in~ es a central opc,nil-g 37 and a plura1ity of ratchet teeth 33 selectively spaced around an outer wall 35 of coll~iner 30. Collt~e,r o 30 also includes a flange 34 that extends outwardly from outer wall 35 of COIl~ lC. 30 below ratchet t~eth 33 and an end of travel lock pin 36 that extends up from flange 34.
End of travel lock pin 36 works with a similar end of travel lock key 26 located on the underside of cover 20 to stop rotation of cover 20 on conlahlel 30 when all cavities have passed under slot 21.

Cover 20 includes a central post 22 having an enlarged head 23. In addition, cover 20 in<~Jdes an outer lip 27 around its ch.;u.l~.~,nce that e.~t~ s down and over cQ~ P,~ 30, when cover 20 is S ~lacll~ to cont~_r 30. Outer lip 27 in~ es a ratchet tooth 25 eyt~n~ g ~_~,rlu~ in the dil~ion of CX~ts~;nf-l- 30 that is f~ n.$io~-P~l to 20 work with the plurality of ratchet teeth 33 on co~t~;n~,J 30 to prevent cover 20 from rotating in a p~d~ ed direction. Cover 20 is mtatably attached to cG.It~ e~ 30 af~er C~ 'P L 30 has been loaded wit~ pen needle ~.C~ li~ 100 and label lS0 has been attached to upper surface 32 of co ~ 30 by ins~,~ing cent~al post 22 into central o~ , 37 in CQ~ P ~ 30 until enlar~ed head 23 snaps to central û~ll;~ 37.
2s When enlarged head 23 snaps into cent~al op~ing 37, cover~2~) is ~t~rh~ to cûllt~
30 such that ratchet teeth 33 on ai~A;~ 30 engage with ratchet tooth 25 ~- ~ ~d;-~

from cover 20 to only permit cover 20 to rotate in one direction, i.e., a clockwise direction. Therefore, cover 20 is not permitted to rotate in the counter-clockwise dir~ction or to move slot 21 back over cavities 31 co.~ ing used pen needles 100.

s Of course, when cover 20 is ~tt~ch~ to co.~ 30 it is important to locate end of travel lock key 26 on cover 20 ;~ nt to end of travel lock pin 36 on container 30, such that cover 20 can proceed wit_ a full clockwise rotation on con~illP~r 30.
Th~lero,e,-when all cavities have been ~c~es.s~d using slot 21 on cover 20 and cover 20 has completed a complete clockwise rotation on container 30, end of travel lock key 26 o on cover 20 will again be adjacent to end of travel lock pin 36 on container 30 but now will prevent further rotation in the clockwise direction. In the current embodiment, cover 20 can never be rotated in the counter-clockwise direction on co-l~inPr 30because of the above-described interaction of ratchet teeth 25 and 33.

As described above, container 30 in~h~des a plurality of cavities 31 around its cih~ re,~"~ce that are ~lime.n~ioned to receive pen needle assemblies 100, more clearly shown in Figs. S and 6 and further described below. Fig. S shows a cross-secti--n~l view of one of said plurality of cavities 31 and Fig. 6 more clearly shows adaptor 50.
As shown in Fig. 5, each cavity 31 in~ es an open end 39 leading to an upper section 42 and a bottom section 41 leading to a closed end 44. Upper section 42 incl~ldes a ~ g ring 46 that mates with a ...~lrlling ~ ;ng ring 55 on ad~r 50, when adaptor 50 is inserted into cavity 31 to attach or detach pen needle ass~luly 100 to adaptor 50. Bottom section 41 has a smaller ~ than upper section 42 with a shelf 43 formed where ~ion~ 41 and 42 meet. A set of threads 45 are loca$ed in the 25 - bottoEn part of upper sectioo 42 ~dj~r~nt to shelf 43 and bottom section 41 is ~limP--~s t~!~Pd to receive a distal point 104 on pen needle ~cs~ ,ly 100.

As shown in Figs. S and 6, pen needle assembly 100 in~ des a hub 102 having a triangular shaped proximal end 109 and a distal end 107 having a set of threads 101 thereon ~iimPncion~ to mate with the set of threads 45 within cavities 31. A needle S c-qnn~lq 103 is mounted within hub 102 and in~ de~ a distal point 104 and a ~ Ah~
point 105, wherein ~)lu~ill-al point 105 e~te,n-ls from triangular shaped ~ .n~al end 109 and distal point 104 e~ct~n~lc out of distal end 107 on hub 102. I~al end 109 also in~ des one or more splines 110 to improve the rotational operation of hub 102 within cavity 31 and increase the force-fit between hub 102 and adaptor 50. After a o plurality of pen needle assemblies 100 have been loaded into pen needle mqg~7in~o, tli~pe,ncer 10 and assembled, as shown in Fig. 4, pen needle mq~.q.7in~, dispenser 10 is ready for mounting in opening 7 of cap 3, as shown in Fig. 2.

As shown in Fig. 3, each newly design~l pen needle assembly 100 within cavity 5 31 can only be removed and mounted on a m~lieqtion delivery pen having an adaptor 50 according to the present invention. As shown in Fig. 5, adaptor 50 in~ lde~ an open plU~illlal end 51 having a set of threads 52 ~1im~n~ioned to mate with threads 8 on dist~ end 6 of conventiQnql m~lie~q~ion delivery pen 1. ~d~tor 50 also in~ ldes a unique triq-n~llqr shaped o~-in~ 53 in its distal end 54. After adaptor 50 'has been dded onto distal end 6 of pen 1, distal end 54 of ada~tor 50 is used to remove pen needle q~s~mbly 100 f}om cavity 31 by ins~lling triqrl~ q-r shaped ~,u~al end 109 of needle qC~Pm~ Iy 100 into triqnglllqr shaped U~ ;ng 53 in adaptor 50. When t iqn~ r sha~ed p~Ai~al end 109 of needle ~cs.~ 100 is inserted into triqngl~1qr shaped openi~ 53 in ~ q~tor 50, rotation of medication delivery pen 1 causes pen needleqcsenlbly 100 to rotate within cavity 31' and drive l.;an,~lqr sbaped pl~.~ end 109 of needle assembly 100 into a forced fit with triqngJlqr shaped o~n;i~g 53 in addlolor ; .

50.

As pen 1 is rotated and needle asse"~bl~ 100 is driven into adaptor 50, pruAh~
point 105 of pen needle assembly 100 pierces mbber septum 2 of the cartridge in pen 1 s to place needle c~nn~ 103 in com",umcation with mefli~tion col~ ~ within the car~ridge in pen 1. The forced fit also holds pn~al point 105 within rubber septum 2 and needle assembly 100 within adaptor 50 during the injection of m~li~ti-)n from the cartridge in pen 1.

o After use, the used pen needle assembly 100 mounted on adaptor 50 on m~ir~tinn delivery pen 1 is neinsFIl~d into cavity 31 until ~ -ing rings 46 and 55 mate and the set of threads 101 on pen needle assembly 100 come into contact with the set of threads 45 within cavity 31. Me~ tion delivery pen 1 is then rotated in the opposite direction to thread pen needle assembly 100 back into cavity 31 and pen 1 is S then pulled out of container 30 as pen needie assembly 100 is pulled out adaptor 50.

The user then rotates cover 20 until slot 21 is aligned with the next cavity 31 having an unused pen needle 100 that is still covered by label 150. As cover 20 is rotated ratchet tooth 25 travels over one set of ratchet teeth 33 on co~t~;nFr 30, which ~o then prevents cover 20 fmm ~ing in the opposite direction. Of course, an alternative to the uni directional cover shown in the dl~lw~gs and des~ ~ above would be a design that allows the user to rotate slot 21 back to previously used n~ll~s.
In that case, no ratchet m~"lun:.~... would be needed but the other f~l~s of the present invention could still be used in such a device. However, as ~es~ ril~1 above ~ 2s- and shown in the dlawillgs, the current design allows the user to l~A~dly rotate cover 20 to each cavity 31 until all of the pen needle ~ .b!i~os 100 have been used and the last cavity 31 has been encountered by slot 21 on cover 20. That last cavity could be left empty so that the user will know that all pen needle assemblies 100 have been used and thereby in-licq~ that pen needle mq~7ine dispenser 10 should now be properlydisposed of. In ~riition~ by providing an empty cavity 31 with all filled cavities 31 s being fully enclos~ behind cover 20, all the used pen needle assemblies 100 and their p.v~Lullal points 105 would be plv~;led from aceide~t~l needle sticks, since cover 20 would no longer be able to rotate in either direction. As explained above, further rotation would be prevented by interaction between end of travel lock pin 36 on cont~inP~r 30 and end of travel lock key 26 on cover 20. If it is desired to use all the o cavities 31 in container 30 to hold pen needle assemblies 100, the app~dlus of the present invention can have a final rotational movement that is limted to a one-half (1/2) unit turn. In that case, slot 21 would be finally positioned between the first cavity and the last cavity with all pen needle assemblies 100 being covered and contained within container 30 and cover 20 being prevented from rotation in either direction.

While the invention has been described with respect to a ~le~ d emb~imlqnt it is ap~ that various chqnges can be made without d~a~ g fr~m the scope of the invention as defined by the q-~xnde~ claims. For example, adaptor 50 can be int~r.ql1y molded onto or ~.. ~ ly qtt~~h~l to distal end 6 of a ..~ ion delivery 20 pen 1 rather than being a ~. ~ part.

Claims

1. A needle assembly for use with a medication delivery pen, said needle assembly comprising:
a hub;
means on said hub for force-fit attaching said hub to a medication delivery pen;and a cannula mounted within said hub and having a distal point and a proximal point.

2. A needle assembly according to Claim 1, wherein said force-fit attaching means includes a triangular shaped proximal end that is received in a matching triangular shaped hole on the medication delivery pen.

3. A needle assembly according to Claim 2, wherein said proximal point of said cannula extends out of said triangular shaped proximal end such that when said triangular shaped proximal end of said needle assembly is fully received within said matching triangular shaped hole in the medication delivery pen, said proximal point extends into the medication delivery pen a sufficient distance to pierce a septum within the medication delivery pen.

4. A needle assembly according Claim 1, wherein said means for force-fitting said hub to the medication delivery pen includes an adaptor that receives said force-fit needle assembly, said adaptor having a set of threads that mate with aconventional set of threads on the medication delivery pen.

5. A needle assembly according to Claim 4, wherein said hub includes a set of threads used to drive said needle assembly into said adaptor when said needleassembly is located in a threaded cavity and said needle assembly is rotated with respect to the threaded cavity.

6. A needle assembly according to Claim 1, wherein said means for force-fitting said hub to the medication delivery pen includes a spline on said hub that mateswith the medication delivery pen.

7. A needle assembly according to Claim 6, wherein said means for force-fitting said hub to the medication delivery pen further includes a triangular shaped proximal end on said hub that is received in a matching triangular shaped hole on the medication delivery pen.

8. A needle assembly according to Claim 7, wherein said proximal point of said cannula extends out of said triangular shaped proximal end such that when said triangular shaped proximal end of said needle assembly is fully received within said matching triangular shaped hole in the medication delivery pen, said proximal point extends into the medication delivery pen a sufficient distance to pierce a septum within the medication delivery pen.

9. A needle assembly according to Claim 8, wherein said means for force-fitting said hub to the medication delivery pen includes an adaptor that receives said force-fit needle assembly, said adaptor having a set of threads that mate with aconventional set of threads on the medication delivery pen.

10. A needle assembly according to Claim 9, wherein said hub includes a set of threads used to drive said needle assembly into said adaptor when said needleassembly is located in a threaded cavity and said needle assembly is rotated with respect to the threaded cavity.