GB2471780A

GB2471780A - Ampoule breaking device

Info

Publication number: GB2471780A
Application number: GB1011549A
Authority: GB
Inventors: David Foster
Original assignee: Summit Medical Ltd
Current assignee: Summit Medical Ltd
Priority date: 2009-07-10
Filing date: 2010-07-09
Publication date: 2011-01-12
Also published as: WO2011003625A1; GB201011549D0; GB0911959D0

Abstract

A device for breaking an ampoule 2 containing liquid monomer, wherein the device is arranged to receive the ampoule and wherein the device comprises one or more spikes or protrusions 6 for penetrating or fracturing the ampoule along a long side of the ampoule. Preferably, the device has a top and a bottom and a longitudinal axis extending therebetween. The one or more spikes may be mounted on a lever 7 forming a side of the device between the top and the bottom of the device. The lever is moveable toward the longitudinal axis, in use, such that the spikes contact and penetrate the ampoule, which is located in the device, as the lever is closed against the device. Typically, the device comprises a filter (4, Fig. 1). The device is used to deliver the liquid monomer to other components for mixing such that an orthopaedic cement is produced.

Description

MONOMER INTRODUCER

The present Thvention s generay concerned with the preosration of orthopeedic cement which has many apoiications. Specifically, the invention is concerned wth \ , sVe c' S" { r'fl\ t\,.s' o In n open bow and, ndeed, some surgeons actually prefer this as they can then test the coflss1ency ot tue mxed cement using their hand, most cc'inrnerca mXer5 00W rnmnrke e d tn wNnh the mhdnc nerk5e or agitator is attached Further, as mentioned above, ampoues are often difficult to break neeDy and this can cause giass shards to enter the cement mixture or the mixing mechanism or to 1\ Sfl0 SLet C' I ra' 10 IuOfl Detso' n.roducer of DoPuy, as shown, for example, in US 200210003146, breaks the necks of the viai using a twisling action.

ir. the known devices where the monomer anipouie or vial is broken by a pin that ampouie stored in a device in many ways, in the preferred embodiment, one or more such spikes or protrusions are mounted on a iever forming a side of the device between the top and bottom, being movable in towards the longitudinal axis, in use, such that the spike(s) contacts and penetrates an ampoule received between the top and bottom of the device as the lever is closed against the device.

When ciosed, the lever preferably forms a seal against the device to provide 5: complete seated housing around the ampouie in an alternative embodiment, the spike(s) or protrusion(s) are mounted on a rotatabie handle, rotation of which causes The spike(siprotrusion(s) to move in reiative to the smpoule(s in the device.

The handle is preferably mounted to the device body by a screw thread.

Thus. in the present invention, an anipoule inserted within the device is broken from The side -Le. by movement of the spike(s) towards the iongitudinai axis, as opposed to being penetrated at the top or bottom i.e. by movement of the spike along the longitudinte axis.

The introducer device is oreferably orovided with an outlet cod, orefarabiv at the bottom of the device, arranged to be located and sealed onto a port of a mixing device such that the liquid monomer from the broken ampoule enters the mixing device Through the outlet port of the introducer.

In order to avoid fragments of glass entering the cement mix, a fitter is preferably provided in the introducer, most preferably in the outlet port, but at least somewhere in the path between the breaking of the anipoule and the iiqud entering the cement mixer.

Preferred embodiments of the monomer introducer of the present invention witi now be described in more detail with reference to the drawings. $

Fig. I shows an introducer of one embodiment, in a closed posiflon, for exanipie as supped by the manufacturer; Fis. 2 shows the monomer introducer of Fig. I in an open position for insertion:of a S monomer ampoule: Fig. 3 srows the insertion of a rnonomerampouie into the introducer of Figs. land 2; Hp. 4 shows the introducer closed, containing the ampoule, the position in which the ampoule will be broken: Fig. 5 shows a more detailed view of the bottom of the introducer, in an open position, showing the position of the spike for breaking the ampoule; and Fig. 5 shows a more detailed view of the same part of the introducer as Fig. 5, but wth the lever dosed.

Fig. 7 shows an aiternadve embodiment introducer mounted to the iid of a mixer; Fig. 8 is a perspective view of the introducer of Fig. 7 containing two ampoules; Fig. 9 is a detailed view showing the ampoule breaking part of the introducer of Fig. 7.

Fig. 10 shows more detailed views of the handle and lid of the embodiment of Fig Fio. 11 is a detailed view in part section. showine; how the introducer of Fio. 7: attaches to a nnxer; Figs. 12 to IS are detailed sectional views of the ampoule breaking mechanism of Fig. 9.

Figs. 16 and 17 show an alternative embodiment.

one embodnient, the monomer nlroducer functkins a tlie hke a nutoracker to bra-ak the ampoue.

The introducer of one embodiment, shown in Hgs. I to 6, comphees a mai'n body or - .j..

prcMded 1th some sort ot a catth or ockng arrangement to ook the hd to the main body in the dosed position. Of course, a separate iid may be provided and trds rin net need c) he intenmthi fnrmeri with the kver.

A atth may be provided on the ever, for examp'e at or near the ki 9, to ock the ever n a dosed posWon after the arnpodes have been broken. to avoU esca of vapour.

xr,.:(ct.. --An:crrnncpent)frj be t ret.an the descn shown n tre drewnqs -.

hav:nn the spkes arranged on a snge ever or sortie; other means for movna e 4hn-' *e r't nrrr.-:S 0 ctat of Fk: 10 shove one e-rtboofrne 4 J a W Uflt S s&r the L'rovcett rt pevous Cmb0O.n)t.nts VV:th refe'en:e. .o Fc's 7 to 15. can. and a ashcuar Fios. I to 15. Fb;:flJse of the secc:.:ic iLOC!,fl0: : \ nOW be tiesunbad.

The ri oducerma% be su0Piei 4h tWO pN.ritourne.d arnpoues 2 as s taw n Fig. Ahe.rnatnak, the can be provded eai: ano the user ccc naer; oreenod. srt:o0thOS, Ltner etcsr.hmems are a}sct osscJe ita'; c or'$ smOoth? fla\.nQ more:nan i!s)o an.po.e3 Bere use. tO hande. flOuOiCO reaive to toe man boov and the ampOuies soon th&. ma sp e r spikes 6' exh?nd nto thw main body but do not actuath? extend as far as the amnotho. THs can best be seen i0 hue. 11 to IS. n n env One Sp!K0 s sno'n end thb in such a posiflon that r s not s I enettabng the amcouhf svrtsce The nirn1uGe S lIen HUed to 3 r;V)lrIq dsvh?e ia is disunsc. port.t' fl a t'nuon.

saiHar re\c.i': deoribod.

Woert the cement is r55dy to be m3xd the ser actuates the. nar.ths o as to atonce the spikes r&ative to toe asia vsaH of he arnpoues1 Fig t I thous dy one spike in a posmon before. 1hs has pene:rated the aritpou;e this embociirnent the so3ke is advanced by rota:bn the ha idie retauve to the nisn body The nandh? is mounted to the rran both: N toear;s ot a thead:nU as the handle a tokaled 4 moe towacs the maftt body, siono the ihrcedI thus :vsnCnQ the spikefs fl 0UU ainbudirnerts the handie. couid be actIvated N pus RId I0 StIVO to the main or b' sortie sticino or other rno'.erten. so as tO ath once the spi4 Into die amc:uIats. 1.'

As with the other embodiments described, if only a single ampoule is provided; ths can be penetrated by a singie spke.

In the embodiment shown, two ampoules are provided, each being penetrated: by a respective spike La the handle is provided with two spikes.

Whilst, in some embodiments, the spikes could be mounted both at the same distance from the ampoules such that both spthes penetrate the respective ampoules at the same time, in other embodiments, such as shown in Figs. 12 and 14, m partIcular, the spikes may be oftset such that a first spike penetrates a first ampoule, iirst, and then further actuation, e.g. rotation of the handle, causes further advancernent of the second spike which penetrates the second ampouia later.

Of course, in other embodiments, where more than two ampoules are rovided, IS more than two spikes may be provided but the same principies apply.

Thus, as can b.c seen in Fig. 12, in this embodiment, a first rotation ot the handle cs uses the. first spike to penetrate the first ampouie but the second spike has not yet reached the ampoule wall of the second ampouie. on

Further rotation of the handle causes the second spke to penetrate the wail ot' the second ampoule, again from the side.

Th,is particular embodiment is very simple to use and, being a compiete field unit, 2.5 avoids the escape of fuse into the environment. The knob is preferably designed such that the introducer can be operated with a single hand.

The handle is preferably snap-fitted into the thread of the main body so that it cannot be taken off.

One problem that has arisen with the embodiment described above is that the amount of force required to compress the spike(s) 6' tended to cause the sleeve I and the handle 10 to distort or pull apart. One possible solution to this is shown in Figs, 16 and 17. Here, a pin 20 passes through the sleeve I and connects to the i3 handle 10 via a thread. When the hanthe is rotated to compress, the entire assembly is puUed together and the spike(s can load uniformly.

The monomer introducer of the present invention can be provided partly pre$ilted Le. pre-fiHed with monomer ampoules but a particular advantage of the present inverThon is tha.t this is not necessary and that any standard ampoules can he used with the monomer introducer. Thus, the introducer of the present application can be supplied as an empty device, not dependent on the type of cement used.

i 0 The device of the present invention, particularly in its preferred embodiments, contains a monomer fumes and also filters any glass from the liactured arnpoule.

The device can be provided as a stand-alone device or may be provided in a kit with or as pert of a mixing device.

in use, the monomer introducer is located and sealed onto a mxnq system. The empoes will then be broken within the introducer and the monomer liquid wilipass through the outiet port ?nto the mixer to be mixed with the cement powder.

The introducer of the present invention is particularly cost effective and allows the clinican to use any' bone cement with this introducer. Compared to cuntnt mixing systems, it has been found that the fumes emitted are greatly reduced or removed.

The introducer is particularly easy to use end ensures that any broken glass is filtered to avoid glass entering into the cement mix or the mixer mechanism or: injuring medical personnel.

The use of the introducer of the present invention avoids the need to break ampoules by snapping by hand and avoid's the need to break ampoules within the mixer device itself. Used anipoules can be safely disposed of.

Claims

C L&!.Th * tor breaknc an ampoLle oian: 11ud ononer \:er;:r a t ncec 1) recere an arnpoue ani steren he deve oomor sea means flf OC naxatno or iracIur.ng the amoC'uk: akn a on side o he ampoue
2 The ievce: or dam I. *her&n the cIevo'c hasitoç and a bottom r.d a k:nçtmi:nel ads ete dnc' beiwen the op and the botCom ndh means for C: *; Ct the arnpoue a oh that the otpituJrta cxterr:f V:6 5OOU5 CotTasPOt)ds eSseflt$UV tO me tonoit:Ina axis of t-oevce, and \fl:e: me deVt.OOn)rtflSeS means 11 r pene atiloOr! 6CttJnrtq the 5flWOU6. Wner: re shied;othhi he oevoa.enirreens to' ntcAtnn ths means for oenetraurq or tcaotu: ,. fl towara the. onttna.a.s.the ctevke of dmm I cr 2 vheren the means for penetratb.p or 11 c.om)nses one or more spkes a:' rn oh:sor>.O6VC6 of $)O) C Wnereh) the ore armors spUces or nrotcjsktns are %C + CC c C fr' C-n * "c :u: :tCkj C V:L,Cbd a V: C) t. Vt' ,t' &tt: tv: : :t:)p cC CC:t CVCLC t m. oeri) rnoveatks to'%a$'d5, he ontuona axs. to use. such fret the spce(s covtacds and penetrates ananpothe receked between the top an I bohom the. do'ove as tOC te er a rsed aganc>t tn devce.

I r( devtr)e of claftn 4. wnereo the ever terms a sea aoanst t:t3 at;vtoC: 5) aS prc\Ide 0: ç':he: seated houstng around the anipoue 6 The devtas of cahn S wheretn he one ore more spiLes er pretrusc:ns are mourned on a ra?aue handie, rotatkn of whon causes the sr$ke s5pmuustoncs C to move n rea;tve to the arnpouets) n the devc.e The dev:ee m am b\vherhn the hancBe s mounted to the nevoe boC Oy' a s& ret th:ead.
3 The de\ ice of an precedtng d:3trn. tnrthe c irrin an c ohit pofr : e5)tar at the bottom o the destce. arrancted tu be toc&ted anj seated onto a port of a rnxng devLce web. that the hquid monomer from the broken anlpouie: enters The mixing devce through the oWlet port of the introducer.9. The device of any preceding claim, further comprising a filter.10. The device of claim 9, when dependent on claim 8, wherein the filter is provided between where the ampoule is penetrated or fractured, in use. and the outlet port, and preferably wherein the filter is provided in the outlet port.