MEDICAL DEVICE FOR SUPPORTING ftM IMPUtftfT OR PROSTHESIS
The present, i n v e n t i on descri bes a novel medical device
b lor s u p p o r t i n g an implant or p r o s t h e s i s . Said device is
made of a r i g i d or s e m i - r i g i d m a t e r i a l and rucpiven EIII
implant or a p r o s t h e s i s in a rernovab I e manner. II.
r e g a i n s in p b i e c a.s J.oEig as the p a t i e n t s u i t e r s no hauu
a s s o c i a l o d w.i th Lhis imp I.FmLation, and the implant or
10 the p r o s t h e s i s i s renewed s u r g i c a l l y or endoscopical 1 y,
in p a r t i c u l a r by the ra~\ r o u t e , as many times as is
nenessai.y. Said device is composed of two p a n t s , one of
which consLiLuLes an upper r i n q , and the othet o: which
c o n s t i t u t e ; ! u lowei r i n g , and id. is intended to r e c e i ve
lb an implant or a reiiiovabl a p r o s t h e s i s aL the upper r i ng
and to be i n s t a l l e d in si/_u by means oi Lhe lower r i n g.
Implants and prostheses are generally i userLed
s u r g i c a l l y and 3r^ replaced when the m a t e r i a l s irom
20 which they LLre made degrade, oi. when they are
o b s t r u c t e d ot rendered non-fnnoti o n a l by organic or
c e l l u l a r m a t e r i a l s . In brief, if replacement ist
e c h n i c a l l y p o s s i b l e , fanci il Lhe s t a t e of h e a l t h of the
p a t i e n t so petmiLs, the surgeon will implant a now
25 functional medicFil device Lo r e p l a c e an i d e n t i c a l bul.
defect.i ve medica I device, 'i'hi s lias Lhe di sadvFirsLage of
c a u s i n g trauma to the i m p l a n t a t i o n siLe, jn the sense
Lhat the t i s s u e which has formed around and on Lop of
Lhe implant or the p r o s t h e s i s will be damaged during
30 Lhe replacement,
The present, invent.i on proposes an alLemaLi v e thaL is
l e s s Lrauvnati.e to t.he p a t i e n t , s i n c e Lhe iitodioa 1 device
t o r supporting an irnplanL or p r o s t h e s i s according Lo
35 the i n v e n t i o n can be colonized by or inl.egxated wiLh
t h e surrounding c e l l s and remains In s i t u when Lhe
surgeon r e p l a c e s the irnplanL or the p r o s L h e s i s . The
enviEontitenL, i TI p a r t i culFir Lho eel 1 nl ar environment, is
t h e r e f o r e not damaged LLL ^J^\ by Lhis surgical
WO 2013/079362 - ? - PCT/EP2012/073117
procedure. The patient recover, s more quickly ft om this
procedure for repl acement of the implLinL or prosfhcsis,
and the surgeon does not have to perlorm any iixing
procedure, since it is t be nove L do vice itse \ t Lhat~
h ensures the placement, guiding and hold ol Lhe implant
or ol the prosthesis.
US 2008/07?'J 12 describes a device for treating sleep
apne.-j by way oi a tracheotomy orifice. 'I'he aim of this
10 device is to regulate the inLra-trachea I. pressure in
rel ation Lo the unibi ent pressure under qi.von condi tions
in patienls who cannot be treated by the conventional
nasal cannulas * Said document describes u telescopic
device intended to pass through Lhe skin and the
lh Lracheal wall of the patient. The various elements sr^.
assembled with the aid of screw threads, for example.
In part:! cul ar, the elements {"^ 4} and () of the device
(10) in FJgus.e 8 dr& not connected to each other. This
device Lhns compri x&s several independent pa r.ts, .i n
2il eonLrast to the device accordinq to tlie invention.
WO 2DQ7/04B93!> describes a method for producing a metal^
impl.ant with open poxes lor ti ssiie support :uid/or
retp I acement. Said document describes i n par Lieu 1 ar Lhe
25 production of an element made of porous titanium
intended Le be colonized In iLs anatomical zone ul
imp! antati on.
WO 2011/Obll77 describes a tool (106) for iaeili rating
-iO Lhe insertion of a speech valve (10) with a flexible
retention shoulder (5 6) into a lis tula between the
trachea and the esophagus of a human patient, having a
WEIII (108) curved to Ueline a passage (116) with first
and second open passage ends and an axis extending
35 between Lhe two, said wall {H)H} having an exLernal
surtaee {118) insertable into a fi sLuia between sai d
t.jnchect and esopbaqus mid defining EI slot (110) which
extends irom the passage {11 f>) to the externa \ surface
WO 2013/079362 - 3 - PCT/EP2012/G731I7
( l i i l ] of Lhe wall (108) , said s l o t (110) having an
open in q at Lhc f .i r s t pfissEjge end extending JJrom tiie
f i r s t . passage end at I east. a pas.t of. the way Lo the
second passage end, and at. E east, a p o r t i on c>± s a i d s l ot
5 (-1)0) proqrRi:^es angul a r l y around said axis as It
p r o g r e s s e s fT.oin Lhe f i r s t passage end to tho second
passage end.
EP 1 735 113 d e s c r i b e s a voice p r o s t h e s i s device (20)
10 ior i n s e r t i o n i n t o LL Lracheo-esopbageal opening oi a
pnLienL, Lhe voice prosLhesis device {20} creal.ing a
passage (36) through same, a tracheal flanqe (24)
ad-jaeenL Lo a t r a c h e a l end, and an esophageal ilange
(76} ad-jacenL to an esophageal end, Lhe t r a c h e a l flange
15 (^4} and esophageal f l.arige {2 G> helping Lo r e t a i n the
voi oe p r o s t h e s i s devi ce {20} lit Lhe tracheO1 esophaqeal
openi ng, characteri zed in LIIE.IL the passage (3h)
comprises a f i is t stop (4 4} extendi nq i nwEirdly from a
s i d e wall (38} oi passage {36) between the LrE.tchea.1 and
20 esophageal ends (24, ?6), and a plnra I if.y o£ second
sLops (4 G} extending inwardly from the s i d e wall (40)
oi Lhc passage (36), and a valve mechanism (50)
a r r a n g e d in said passage and held in p I a c e by sa.i d
i i r s L and second s t o p s.
The pr.eseEit i n v e n t i o n d e s c r i b e s a medi oal device ior
s u p p o r t i n g nn implant or p r o s t h e s i s , which device is
composed oi Lwo parLs, one of which c o n s t i t u t e s an
upper ling made oi a r i g i d or serin - r i qi.d, aolid
30 biocompatible m a t e r i a l , and Lho other of which
c o n s t i f n f . e s EI lower rinq made oi a r i g i d or s e m i - r i g i d,
porous ctr iiiLegratable bioeontpEj.Lible fiiateri a I , said
devi ce bei rig intended ho receive art imp] a n t or a
removable p r o s t h e s i s at the upper ring and to be
35 i n s t a l l e d in s.itf) by means of Lho lower r i n g . Thus, in
the device according to the i n v e n t i o n , Lhc technical
i u n c t i o n of the upper rinq is to r e c e i v e Lhe retmovab I e
prus t h e s i s , whi I o the teohni ca I function oi Lhe 1 ower
WO 2013/079362 - 4 - PCT/HP2012/073I17
r i n g ig to be iriLcgrated in situ in the pat.ienL in
o r d e r to permit a eel] colonizLtLion that, leads - to Lhe
anchoring ot Lhe device according Lc the i n v e n t i o n in
t h e Lissues ei the pdLient. ft. is Lherefore c l e a r thnL
5 the Lwo p a r t s are r i g i d l y j o i n e d (connected Lo each
o t h e r ) in the device a c c o r d i n g t o t h e i n v e n t i o n.
The a t t a c h e d t i n u r e s i l l u s t r a t e the present i nvonti on
and some of the emhodimenLs thereof. The t e c h n i c al
HI l e c t u r e s shown in Lhe figs-ires are not to he r e g a r d e d in
any way an l i m i t i n g Lhe scope ol Lhe pre:;enL i n v e n t i o n.
F i g . 1 shown Lhe upper ring {1} of the medical support
device according to i_he invenLion. This ring can have
15 several shapes depending on Lhe implanL or Lhe
p r o s t h e s i s thaL is to be r e c e i v e d.
Kig. 2 ^hows the lower r i n g (^} oi Lhe medical supporL
d e v i c e according to the i n v e n t i o n . This ring can have
2 0 dif" t.erenL lenqLhs and t h i c k n e s s e s depending on the
implanL or t h e p r o s t h e s i s t h a t is Lo be r e c e i v e d.
F i g . 3 shows a compLeLe medicai support device
a c c o r d i n g to the i n v e n t i o n . The upper ring (1) and the
7!> lower r i n g (2) can be seen h e r e.
F i g . 4 shows a complete medical support. device
a c c o r d i n g to Lhe i n v e n t i o n . The upper ring (1) and the
lower r i n g <2) can. be seen h e r e , both oi Lhein equipped
30 with openings (4)-
l''ig. 5 shows a pEirLicul ar embodiment ol Lhe medical
d e v i c e according to Lhe invenLion in which an e Lenient
{?•) is added under the lower t i n g (2) , 'I'hiu t y p i c a l ly
35 reprfiseuLs a support, i o r a l a r y n g e a l implant, which w i ll
be fixed on the trrichea a f t e r Laryngectomy. The areas
with openings {4} permiL fi xati.on Le the surrounding
t i ssiies by s u t u r i n g.
WO 2013/079362 - -y PCT/EP2012/O73117
Fig. 6 shtjwu a device {60) aceordi rig to Lhe inv.enl.ion,
which represents EI support for a laryngeal prosthesis.
This device (GO) has a grooved ahape, and a tube (61)
5 has been inserted inLo this device. The orifices {b2)
and (62) blowing Lhe passage of sutures tor
intplanLaLion oi the device ^r^ also visible.
Fig. '/ ahows a sLopper (71) intended Lo be fixed in the
10 upper part of the device (60}, in order. Lo close Lhe
laLLer. An auctioning means (72) has been shown, and
also orifices (7 3} intended Lo a H o w threads Lo be
passed through in order to wiLhdraw this sLopper (71)
tor insertion of a laryngea I. prosthesis.
Fig. 3 shows a laryngeal prosLhesis (HI) which is
intended to be inserLed into the; device (60} and which
has the clemenLs needed to obtain a function similar to
the nEiLura.l Larynx. Two flaps (#2, S3) can thus be
20 seen, and also Lwo hinges (04, 8h) . The element (H6)
permits anchoring of Llie prosthesis (31} in Lhe ring
(60)i preventing any movement in translation. The
elements (07} permit suitably posiLioning of the
prosthesis (ftl) in the ring (60) when the laLLer hat;
25 facets in its upper par L. These elements al so prevent
Lhe prosthesis (Wl) from moving in lotation in Lhe ring
(GO) .
Fig. 9 shows a ctoss section of the tube (GJ) shown in
."SO Figure G, The stopper (66) will be seen in particular,
and also iLs tab (67) , which is provi ded for
withdrawing iL through the mouLh. h'l evasions (6^, 65)
defining a neck permiL fixation of Lhe stopper (66) and
prevenL any accidental .movement j_a trans I a Lion i n Lhe
35 tube (61) .
h'ig. 10 shows another embodiment of the tube (61). A
groove (69) is shown which allows Lhe tube t.o be torn
WO 2013/079362 - 6 PCT/EP2 012/073117
along Lhiu groove after pulling en Lhe Lab (68). In
Figure 11).B, which shows Lhiti tube [61} in orotic
section, the elevations (64, 6b) peemitting the
iixati on of the stopper can al:;o be seen. Ii; i.hi:;
b embodi ment, the tube (61) can be wi thdrawn throuqh the
mouth.
The pro sen L i nventi on more pa rt.i cularly describes a
medical device for supporting an implant or prosthesis,
10 characterized in that it is composed oi two parts, one
ol which constitutes an upper ring (1) made ol a rigid
or semi -ri qid, -solid biocompatible material, etnd the
otter of whi eh constitutes a lower ring {2) made ol a
ri qi d or semi-rigid, porous or in Leg ratable
1 !i bi ocornpatible mater, ial, said devi ce bei nq i ntended to
receive an iinpl ant or a removabl e prosthesi s Fit tbe
upper ring (1) and to be installed in aiiu by means of
the lower ring {?.) -
20 The upper (1) and lower [2) rinqs are made of a rigid
or semi-rigid bi ooompati bl e materi al such as ceramic:;,
metals or metal -based a 1 1 oys, pol ymers such as
silicone, or materials of natural origin. In a
par ticular embodi ment, the bi ocompati bl e mater ial is
2b rigid and ol a metallic nature, .In a preferred
embodiment, the upper (1) and lower {7) rings are rnade
of a biocompatible material of a metallic nat.nro,
preferabIy titanium or a ti tani um-based al1oy. In
another preferred embodiment, the upper ring {!) i.s
30 made of solid titanium or of an alloy based on solid
titanium, and the lower ring (2J is made of porous
titanium or of an alloy based on porous titanium,
The tjhupc ol Lhe upper J. i nq i s chosen depending on the
3 b iiuplE-ini. or Lhe prosthesi a that if will receive. This
shape, and Lhe material obosen, will allow the implant
or the prosthesis to be f i xed di recti y to the medical
support device accordi nq to tbe i nventi on. Thu:;, Lhe
WO 2013/079362 - 7 • PCT/EP2012/073117
shape of the upper ring (!) is selected in order to
lecoivc Lhe shape of the implanl. or of Lhe prnsLhesis
for which it wi 1.1 provide the :iiippoil.( and said tapper
ri nq {1} can be equipped with a means ior. anchorinq the
5 .implant or Lhe prosLhesis, tfaid auchor.iny means is
selected from amonq a lixation system providing iockinq
by rotation, by shrink-lit or force-fit assembly, by
Lhreadinq, by £ixinq wiLh springs (clips), by lugs, by
hoops, by oounLersi riking or by interlocking. Jn a
10 preierred embodiment, the anchoring means is a system
oi clipping or iixing wiLh springs, .Ideally, Lhe upper
ring (1) has a concave ouLer geometry, allowing the
total muss of the component. Lo be reduced, while at the
same time ensuring Lhat it does noL injure the paLient.
J5 In a parl.ieular embodi rnent, the upper ring (1) has an
outer shape Lhat is cylindrical, Lhen concave, and once
again cylindrical in its area or coniaeL with the lower
rinq [2] . This is illustrated by Fly . 3. 'I'hi s upper
ring (1) can also be provided wiLh iaeeLs in its upper
20 part, by which the implant or the prosLhesis i_o be
inserted can be locked in rotation. Figure 8.A shows,
in a laryngeal prcsthesi s, the elements (87)*
complement inq Lbe faeeLs that, may bo present in Lhe
upper rinq [1} , This allows the icitpl^int or Lhe
2b prosLhesis to be pi need in the rinq in Lhe position
desired by the surgeon, if th.i s implant or prosthesis
is noL a. body of revoluLion. The number oi possible
posiLions for Lhe impiEuiL or the prosthesis depends on
the number of iuoets in Lhe upper rinq (1) . Genera I Ly,
30 it is preierabl.e Lo have boLween 12 and 2D Lacets, in
particular 16 facets, which allows this implant or
prosthesis lo be Lurneri in sLeps of SB to 30 degrees
(in particular 22.5 degrees} . Any ether equivalent.
means may be considered.
35
The device according to the invention is in iact
preferably symmetri eal ubout an axis oi revolink ion,
which allows the surgeon Lo implant it. wiLhouL worrying
WO 2013/079362 - 8 - PCT/EP2012/073I17
abouL a given ori enl.aLion of t h i s device, since the
noriGcL o r i e n t a L i o n of Lhe implant or of Lhe p r o s t h e s is
i s o b t a i n e d by v i r t u e oi Lhe presence of Lhe f a c e t s ,iL
t h e p l a c e where Lhis implanL or p r o s t h e s i s is to be
5 i n s e r t e d iitLo t h e d e v i c e.
In a p a r t i c u l a r embodiment. of Lhe medioaL device
a c c o r d i n g to Lhe iovenLion for supporLing an implant or
p r o s t h e s i s , the lower r i n g {?) and Lhc upper r i n g (1 )
.10 have' openings (4) thaL allow th^ device Lo be E;uLured
t o the surrounding t i s s u e s by surgery*
In anoLhcr embodiment, Lhe medical device according to
t h e i n von Lion i o r suppor Ling an -imp I anL or p r o s Lhe si s
15 al so haEi an element (.i) s i t u a t e d i;nder Lhe lower r i ng
{?.) and made oi a r i g i d or s e m i - r i g i d biooorrtpaLibl e
rnateri a l , saiii element [3} c o n t r i b u t e nq Lo holdi ng Lhe
d e v i c e according Lo t h e iiivenLion in posiLion, in Lhis
c a s e , tho medical d e v i c e according to the i n v e n t i o n lor
20 supporting an implant or p r o s t h e s i s has Lhree parLs,
one of which c o n s t i t u t e s an upper r i n g (1) marie ol a
r i g i d or semi-ri q i d , so I id biocompatibl e maLeri a l , Lhe
o l h e r of which coriEiLitut.es a lower r i n g (2} made oi a
r i g i d or semi - r i g i d , porous or i r i L e g r a t a h le
?.?, bieeompaLibl e m a t e r i a l , and the Lhird ol whi ch
o o n s t i L u t e s an clenienL (3) mad^ oi a r i g i d or semi -
ri q.id biocompaLible materia"! , said devi ce being
i n t e n d e d to receive an implant or a removable
p r o s t h e s i s at the upper r i n g (1) and to be i n s t a l l e d in
30 situ by means oi the lower r i n g (?) . Such a device is
i l l u s t r a t e d in Fig, ri -
The upper r i n g (1) and the clement (3) CFHI a d d i t i o r a l l y
bo provided with openings (4) intended Lo receive
Mi surgical suLures by which the surgeon w i l l fix the
d e v i c e rlfif i n iL i ve Ly Lo the implanLati on tlEisue, The
implant or removable p r o s t h e s i s w i l l be engEiycd on the
upper ring (1) by way of an anchoring means- The
WO 2013/079362 - '3 - PCT/SP2012/073117
sutures will block the device accordinq Lo the
invention cm the iifipl antati on Liu sue, while the
removable part (implant or prosthesis) is fixed by an
anchoring meant; as described above and not by surgical
5 sutures.
The medical device according to the invention for
supporting an implant or prosthesis has a lower ring
(?.} whosu shape corresponds Lo the anatomical shape of
10 Lhe tissue lor implantation of said device. In other
words, if" Lhe device according Lo the invention is Lo
bo fixed on Lissue of a circular shape, the lower r.iiig
(2) will have a circular shape complementing Lhe shape
el said tissue, and, if the tissue has an oblong shape,
lb Lhe lower ring (2) wi 1.1. have an oblong shape
complement.! ng the shape of said Lissue. Similar! y, in
Liio case where an clement (3} is present under Lhe
lower ring oi the dev.i oe Fiooording to the invention,
Lhe shape of Lhe lower rinq 12} and of the element ('3)
70 corresponds Lo the anatomi cal shape of the Lissue lor
implantation of said device. In other words, if the
device according to Lhe invention is Lo be fixed on
ti s:iue of a circular, shape, the lower ring (2) and the
elemenL (3) will both have a circuLar shape
25 coTisp I emejnting the shape of said tissue,
The lower ring (2) is intended to be colonized by or
integrated with Lhe implantation tissue, and iL is
Lhcrefoi-e made oi a semi-rigid or riqid, porous or
."SO inLegratab! e biooouipuLibl e niaLoriai, 3uoh a materi nl is
typically solid metEil or an alloy based on solid metal,
porous metal. or an alloy ba^ed on porous metal,
silicone or ceramic, Lhcse el ernents being used alone or
in combination, and in various focms such :i:i a. sol id
35 ring, a superposition of layers, a Lhrcad, a lattice, a
weave, a bond, a sLenL or spring, or Einy other
equi vnlent form sat.i slying the technical features oi.
the pre;jcnL invcnt.i on .
WO 2013/079362 - 10 - PCT/EP2GI2/073117
The clement (3), which is f i x e d Lc Lhe lnuor r i n g [2} ,
i s composed ol a r i g i d or s e m i - r i g i d m a t e r i a l that is
b i o c o m p a t i b l e . The element (3) c.nn bo a t h i r d r i n g made
5 of a iiictaJ on of a cue Lai a l l o y , p r e f e r a b l y t i t a n i u m.
'I'he element i'3) can alau be a ring made of ceramic or
s i l i c o n e - The element {3) can f i n a l l y be a t h r e a d , a
l a t t i c e , a weave, a bond or a s t e n t , also made of a
metal or non-metal biocompatible m a t e r i e l . In a
10 p a r t i c u l a r embodiment, tlie clement (3} is f i t t e d on the
lower r i n g {2} and matches Lhe shape t h e r e o f . i t s r o le
i s to s t a b i l i s e Lhe device a c c o r d i n g to Lhe invenLiori.
The novel, medical support dev.i oe according to the
I h invention is p a r t i c u l a r l y s u i t a b l e for aupporLing a
l a r y n g e a l implant. Some diseases such as cancer
soErieLiiii.es r e s u l t in LoLal a b l a t i o n of t h e l a r y n x . Each
year, about 1,850 people in Franco undergo a tol.ai
laryngccLomy. To r e s t o r e the tunc Lions of Lhe larynx,
2 0 several techniques have been proposed, such as
t r a c h e o s t o m y or a laryngea1 t r a n s p l a n t . however,
tracbeosLomy o i t e n ! c a d s to i s o l a Lion associated. with"
l o s s oi speech, and a Lolal l a r y n g e a l t r a n s p l a n t is ouL
of the questi on 2 n i.ho case ot p a t i e n t s t r e a t e d lor
2 5 cancer. Consequently, the p r e s e n t i riven Lion d e s c r i b e s u.
medical device for s u p p o r t i n g an imp.l EJUL or pros Lhe s i s,
which device is implanted on the t r a c h e a of a p a t i e nt
having undergone t o t a l ablaLion of the larynx and wh"ich
thus ensures a s t a b l e j o i n between s a i d Lrachea mid the
30 implant or Lhe laryngeal prosLhesi s. In a p r e f e r r ed
embodiment, the above-described me-di c a l devi oe for
s u p p o r t i n g an implant or p r o s t h e s i s is one in which the
upper r i n g (I) and Lhe element (3) ar is between 3
and 9 cm, preferably about 7 cm. In any case, Lhe
surgeon will be able t.o cut Lhe Lube to Lhe desired
-TTi JongLh, taking .into recount, the anatomy oi Lhe patient
(size of the neck, site of the Lracheostomy hole, size
ot Liie ti ssues removed during Lhe operation, etc. ) , it
being understood t.haL this tube should be able to serve
WO 2 0 1 3 / 0 7 9 3 6 2 - 13 PCT/EP2012/Q73117
as a prop in order lo allow the device to be c o r r e c t ly
p o s i t i o n e d wlLh respoeL lo Lhe t r a c h e a . In p a r L i c u l a r,
t h e tithe eaii be in:jaiLi;d i n t o the trachea Lo ensure
t h a t the alignment i.s s u i t a b l e . The tube as such is
5 also p a r t of Lhe s u b j e c t niuLLer oi Lhe I n v e n t i o n.
I n Lhis embodiment, said device is p r e l e r a b l y made el"
LiLanium. In t h i s a p p l i c a t i o n , il_ w i l l ttlso be a b l e Lo
he d e s i g n a t e d aa LL Lraobea I r i n g.
10
I n a p r e i e r r e d embodiment, the tube {61} is a si 1 i cone
t u b e . Any other material twfi be used, although it.
should be borne in mind that t h i s TnaLerial must
n o n e t h e l e s s have the i o l l o w i n g p r o p e r t i e s : a degree of
15 deformabi 1 i l y (since Lhis Lube must be able lo be
i n s e r t e d in%.e Lhe t o p ol Lhe t r a c h e a of t h e paLienL) , a
degree of r i g i d i t y [since Lhis Lube must he able to
s e r v e as a prop Lo ensure LliaL Lhe d e v i c e i s cos.recLly
posiLioned in Lhe axis el Lhe t r a c h e a ) , and
20 biocoEitpatibi 1 i ty (on FieoounL ei iLs i m p l a n t a t i o n in
huiiitiEis) .
In a p a r L i c u l a r embod.iinent (and subjecl. Lo Lhe p r e s e n ce
oi clevaLions such as those d e s c r i b e d below) r the
' J ' . -y t h i c k n e s s of the Lube (61} is constFint nlong itr> enti r.e
l e n g t h . Irs p a r t i c u l a r , a tube is envisioned with an
e x t e r n a l diameter oi 20.5 mm and an i n t e r n a l diameter
of 1H niiii ( i . e . a t h i c k n e s s of t h e t u b e of 1.25 mm),
30 In another embodiment, said Lube (61) has a h e l i c a l ly
c o n f i g u r e d tear- zone ( h e l i c a l groove) (64) , which
a l l o w s the tube (6t) to be Lorn afLer t r a c t i o n is
a p p l i e d to one of the ends oi. Lhe Lube I6"i). 'I'his is
illusLx-aLed in Figure 10. In t h i s embodiment, the
3b Lhickness of the Lear zone must make 1L p o s s i b l e Lo
inaiEiLttin the i n L e g r i t y of the Lube in vivo, while
peniiiLLing c o n t r o l l e d t e a r i n g undo-L Lhe e f f e c t of Lhe
LraeLien. A t h i c k n e s s of t h i s zone oi Lhe order oi
WO 2013/079362 - 14 - PCT/EP2Q12/073117
about. 0.0b mm is envisioned- In Lhis- embodimerit, iL Is
preferable Lhaf. the tube has, at. one oi its ends [Lhe
end that: will be litLreduced i nt.o the Lrachea.l ri nq) , a
rod/tah (68) that IL wll.l be possible lor Lhe siirqtion
5 Lo grip (with Lhe aid el forceps) in order Lo exert the
Lraction allowing the Lube to be torn- This embodiment
makes it possible to withdraw this tube (61) through
Lhe mouth when it is no longer of use, aft.oi evaluation
by Lhe surgeon. Such a Lube can be obtained in a
1 0 suil.ablc mol d .
The kiL can a t no comprise a sLopper (66) (as with the
tube [&1) f this stopper {66) is preferably made of
silicone}- This tsLopper (66) is removable and is
intended Lo be positioned in Lhe Lube (61) , IL is
intended in particular to prevent mucus from rising
from the lungs and contaminating the L±-acbea I ring
during the coloni 7at ion, in parti r.u~\ ar by limi ti nq the
presence of baeLeri a during Lbi s col oni zation.
In Lhis embodiment, the Lube (61) prefeiably has two
elevnl.ions (which between Lhem define a nock) in it.;;
internal d.iameter (on^ being higher than Lhe other).
This allows t.he stopper Lo be clipped in place, such
that iL does uoL move uJ Lor implant at.i on. The hiqhor
elevation (64) is situated in Lhe lower par L of t.he
tube (61) {dishally from the tracheal rinq) and serves
to prevent Lhe stopper from dropping into t.he Iraohea.
The less high elevation (6b) is situated in t.he
proximal parL of t.he tracheal ring.
The diameter of t.he sLopper (66) is Lherefore less than
Lhe internal diameter of the tube {61). In a parLieular
embodiment, Lhe stopper {66) has a l.ixb (67) - This Lab
.-3b i^ inLended Lo allow Lhe stopper (66) Lo be easily
withdrawn beiore t.he prosthesis (£51) it fitted. IL
nuliices in Lact to pull on this tab in order Lo
jelease Lhe stopper (66) and withdraw iL Lhrongh Lhe
15
2 0
??}
30
WO 2013/079362 - 15 - PCT/EP2012/073I17
moist, h. This Lab is therefore sufficiently long and
penetrates inLo the iracheal ring after the tube (til)
iias beien fixed there.
5 IJI this embodiment, the tracheal rinq is positioned in
Lho patient iust after the ablation of the larynx,
during Lho same operation. The tube (61) is intended to
bo in.l_rodi.sced into the trachea of the patient and to
position the tracheal ring in such a way UiaL the
10 latter is correctly aligned with the trachea. The.
presence oi thi s tube (61) can also serve as n prop for
the eel 1 s that colonize Lho area of implantation oi the
dev.i oef a J I owing the;ii; ceils Lo lorn, a condui t around
this tube (61} and ensuring LhaL they do not. niiqfiaLo
15 underneath or inside the tracheal ring, which could
reduce the usef u! di arncLor oi the trachea or even
occlude i t , Initially, i t makes it possible (parti en I arly
in the presence of the stopper (66)} Lo protect the
colls, whi ch are intended to colonize the area oi
20 porous titanium, from the presence oi mucus eovninq from
Lho lungs , This is i ntended to main Lain a colon i 7FIT: ion
en vir oilmen L that is as sterile as possible. This tube-
{61) will bo able Lo be withdrawn by the suxgeon after
a certain Lime (once he considers the tracheal ring to
?l\ be suitably fixed} •
In this embodiment. Lho kit can also comprise a stopper
(71} intended to be introduced into the upper part.
(part. mF_do of rigid metal) of the tracheal ring (60),
30 in order l.o obstruct. iL and lo guarantee thaL it is
seal ed. Find Lo avoid any passage of air or oi food
during the phases of colonization and cj cat.ri zation. On
its lower pFirL, this stopper can comprise elements (72)
permitting reversible fixing Lo Lho tracheal ring via
35 the anchoring means of the tracheal ring, if the latter
hcits such -means. It can comprise orifices (73} in iL_i
upper part in order to a IJ ow one or more threads to be
passed throvrqh so as to withdraw said stopper through
WO 2013/079362 - 16 - PCT/KF2Q12/073117
t h e month a f t e r c l e a t H zaLion and impl ant. LA Lion of: Lhe
r i n g in the p a t i e n l,
The stopper cart have a male cone shape which will f-si:
h inLo the t r a c h e a l ring (upper par L poss.ibly having a
teiiiale cone .shape} . IL wi.l 1 of c o u r s e have t h e elements
billowing it to be engaged in the faeeLs of the LracheaI
rirng, if the LaLter has such f a c e t s.
10 The k i t accurdinq Lo t h e invenLion can a l a o c o n t a i n a
rcEiiovabl e element (larynx prosLhcsis) i ntonded to be
f i x e d on the device according Lo the invenLion s£lor
i m p l a n t a t i o n in the p a t i e n t . Such an ei.oiiicnL, also
iorming p a r t of the s u b j e c t matter of the invenLion, is
1 li shown in H'i g u r e & -
Thi:; removable element is composed of a body (81) ^made
of biocompatible metal ( p r e f e r a b l y oi s o l i d t i L a n i u m ).
?0 In the upper p a r t ot Lhe removable parL (which wi.l 1 he
s i t u a t e d proximal to Lhe end of t h e Longue), t h e r e a re
two concenLrio. f l a p s (W2, 83) . Downward opening of the1
gmal 1 i i a p { H j* > permits inhsl at i o n , whi 1 e upward
open i ng of he Lh flaps {sma 11 -i lar^ge) pcrmi t s
25 e x h a l a t i o n.
The p r i n c i p l e oi the flaps is described in L"he
a p p l i c a t i en El1 2 24 0 120, However, Lhe removab] e
element as en In a ^ r e f e r r e d embodiment, the a s s i s t a n c e device is a
magnetized devi c e . Magneti zed devi c e or magnetized
element is understood as one or more permanent magnets
of the l a n t h a n i d e type whi eh are b i o c o m p a t i b l e or are
WO 2013/079362 - 19 - PCT/EP2012/073117
r e n d e r e d biGOorripaLibl e by v a r i o u s t r e a t m e n t s known to LI
person s k i l l e d In the a i l , ox else are onol o.s^d
h e r m e t i e a L l y in EL su.1t.shle housing provided Lor t h is
purpose- ftaid magnetized device can be placed e i t h e r on
\ i the f i r s t fl.up {i]2) or on the i n t e r n a l s u r f a c e ol Lhe
snpponLing framework (B 1> , ffihsn t h e f i r s t flap is in
t h e closed p o s i t i o n , EI m e t a l l i c element is pLaeed
o p p o s i t e the one or moio magnets. Met a \ Lie el emenL is
u n d e r s t o o d as one or more m e t a l l i c elements capable of
10 being magnetized and placed iu such a way as to come
i n t o contact with the one ox mere magnets when the
f i r s t f]ap iy in the c l o s e d p o s i t i o n . The n a t u r e of the
iftagneti?ed dev.i c e will be able to be adapted to each
s i t u a t i o n by varying the number oi magnets and/or t h e ir
1 !i p o s i t i o n , fox example. J t is a l s o conceivable to UHC
two magnets lae.inq each o t h e r.
Thus, in a p a r t i c u l a r embodiment, the laryngeal
p r o s t h e s i s has an a s s i s t a n c e device consi s t i n g of a
70 m e t a l l i c element" arranged in the area of the annniax
suppor t i n g framework (81) and coming i n t o conLact wi th
a maqnetized element arranged in Lhe area of Lhe f i r s t1
f l a p (H2) . In a p r e f e r r e d embodiment, the Laryngeal
p r o s t h e s i s has an a s s i s t a n c e devi ce e e n s i s t i ng of a
2h m e t a l l i c element arranged in the area of Lhe f i r s t flap
[82} and coming i n t o contact with a maqneLized element
a r r a n g e d isi the area of Lhe annular supporting
f lajiiework (81) .
311 A mechanical assi sl.unce device can a l s o be p o s i t i o n ed
on each of Lhe flaps in order Lo faci .LiLaL EH id the simultaneous liftinq oi the firsL
ilap (0?) and of the second flap (513)-
h
When said device itsoli has anchoring moans, s;tid
removable elemenL has means complementing tho^e (Rfc) .
In a pnrlicul at embodiment, Lhe part of said removable
element iitLended Lo be introduced into or atLitched to
10 the devi oe according to the i nvonLion is asymmcLrical ,
This assi st.^ the surgeon dnri rig Lhc impl anta Lion of
Lhis removable element by i ndicnLing the correct
orientation Lhat has to be observed, Thus, the
laryngeal pioaLhesis is positioned in such a way Lhat
lb Lhc hinge parL (G 4 > is appl i eri aqninsi Lhe base oi Lhe
palienl' s tongue , 'This posi ti oni nq Find Lhis ori enLuLJ on
can be obtained by slightly pivoting Lhe laryngeal
prosLhesis according Lo the facets oi Lhe trachea!
liny, if the latter has these, unLii Lhe suiLable
70 posiLion .is reached.
'I'he present invention also describes a method lor*
supporting and lining an implant or EJ prosthesis
according Lo the present, invention, in which method a
25 device according Lo the invenLion is placed securely on
a tissue intended to receive an impianL or a
prosthesi s. The meLbod involves surgi cal 1 y iixing the
support according to Lhe invention on a tissue inLended
Le receive an impianL or a prosthesis.
.-JO
Tri a parL.i on Lnr erribodimenL, the invenLion r e b a t e s Lo a
method for supporting and f i l i n g an implant or a
p r o s t h e s i s according to Lhe p r e s e n t i n v e n l i o n , i n which
method said snpport ia placed s e c u r e l y on Lhe t r a c h ea
35 of a pal.ient in order to r e c e i v e a laryngeEil implant or
p r o s t h e s i s . The method involves a step oi s u r g i c a l ly
f i x i n g Llie support to the walls of the t r a c h e a of Lhe
p a t i e n t who has underqono a laryngectomy. Once Lhe
WO 2013/079362 - 21 • PCT/EP2G12/0731I7
support is fixed Lo the trachea, the implant or the
prosthesis is inserted through Lhc moLilb. and -clipped
ont-o the supDoti..
5 Thus, L"he invention also relates to a method oi
LreaLiny a patient havinq undergone ablation oi Lhc
idiyns, comprisi nq the step of i nf rodnc.i nq a ] ar. yntjeal
prosthesis. into thi s pa hi ent, said prosf.be si s being
introduced through the mouth of the pat.ient.
10
In particular, the invention relates to a method
eompH si.nq the step of i nt.rodnoi ng a 1 a;, ynqeal
prosthesis orally into a pati ent havi ng undergone a
] arynqectomy, and of f i tvti ng a devi ce as descri bed
1 f> above, said \ aryngeal prosthesis being fixed to sai d
devi ce.
The invention reJ.al.cy to a method oi treating a. patient
having to undergo a laryngectomy, said method
20 comprising the steps oi
a) ablation of the larynx,
b) fitting a device as described above in Lhc Lrachea"
oi Lhe pati ent.
25 IEI Lhis method, said device is sutured to the tissues
oi said paLient. In particular, said device is
preferably positioned in such a way that the part iaa.de
oi solid LiLanium is sutured to the byoid bone and/or
to the base of the tonque, whilf? the part, made oi
.-SO porous t i tanium is posi t.i oned end to end wi t.h the upper
part of the Lrachea and connected thereto by loose
sutures. 11 i s l.hus placed slightly (0 to 3 mm) Fibove
Lhe Lrachea of the pa Lieut.
3b In this eciibodiment, it is preiened to use a Lube
(preierubly made of silicone), oi" which one end is
inserted inLo said device {from flic side wilh the
porous metal) and the oLher end is inserLed inLo the
WO 2013/079362 - Tl - PCT/EP2012/073117
Lrachea, by whi oh means II: is possibly to guide the
inl.roducti on and placement, of Uie device during the
i nteivenLion.
5 hi this connection, tho surgical steps LhaL should be
performed within Lhe conLexL of the piosenL invertLion
are the iollowi sig .
Ablation of the larynx and opening ol a
10 tracheotomy hole; Lhis tracheoLomy is at
present necessary Lo allow the patienL Lo
continue breathing duri ng the peri od of
colonization of Llie tracheal ring. The
tracheotomy hole is intended to be plugged
1 !> after the laryngeal prosLhesi s has been fit.Lcd
in place.
Placement oi Lhe tracheal ring {i ntroducti on o£
the silicone tube inLo the trachea, and
sutniing of the tracheal ring to the Lissues ol
20 Lhe paLient} ; Lhe ring will b^ surrounded by
muscles in order to permit good physiological
iii.Legrai.ion and Lo hold it. In place without
movements.
This ring has a stopper in iLs upper part
2b (which can be inserLcd after the ring h,is been
p Laced in situ}, which is also the rigid metal
parL proximal to the base of Lhe tongue. A
stopper case of th^ support according to the i n v e n t i o n for a
l a r y n g e a l implant, this upper ring {"!} is c y l i n d r i c al
wit h an outer shape t h a t is ei their s t r ^ i . ^ h t (see h'i q.
WO 20I3/O79362 - 24 - PCT/EP£012/0?3117
1} or t r u n c a t e d (seR F i g u r e s ."3 to :,) at i t s c e n t e r with
c y l i n d r i c a l and s t r a i g h t ends.
In another embodiment, Lhc upper ring has a grooved
!•> (Fig, ?)} or f?vcn fhneaded shape. This shape i s
p a r t i c u l a r l y advantageous in the context of a support
i o r a laryngeal implant.. Irs t h i s case, Lh and to permit c o l o n i z a t i on of
t h e porous mejf.Etl by the t i s s u e s . Such a grooved (or
threaded} shape can l i m i t the s l i d i n g of t h e IILUSCIRS OII
Lhe s u r f a c e of t h e upper r i n g.
lh
The implant or the prosthesis is fixed in this upper.
r.ing by way of the anchoring means. For a l.aryngea 1
implant, said implant i s typically clipped onto the
support.
20
The lower ring (?) has a s t r a i g h t cy! i n d r i c a 1 shape
and is p r e f e r a b l y made of porous t i t a n i u m . it is
equipped with s e r i e s of openings (4) so that the
surgeon can sew the support onto the walls ot the
?b trachea oi the p a t i e n t . There can bo a. s i n g l e s e r i e s of
openings between the upper r i n g (1) and t h e lower ring
{'I), as is i l l u s t r a t e d in Fig. ^, but t h e r e can a l s o be
n supplementary s e r i e s oi openings (•!) under, the lower
r i n g (2>, as is i l . l u s t r a t ^ d in Fjg. A.
30
I n or.der to stabi Lize the support device accoiding to
t h e i n v e n t i o n on the trachea oi the p a t i e n t , it is a l so
possibLo to provide an element (3) which will be
engaged around the trachea. This element (3} is
3b Situated undftt the Lower ring {2), The element (3) is
made ol a s e m i - r i g i d or ri g i d b i o c o m p a t i b l e m a t e r i a l .
In the case of the support for a l a r y n g e a l implant, the
element (3) can be made of s o l i d t i t a n i u m.
WO 2013/079362 25 PCT/EP2G12/073117
.Such a support device according to the i n v e n t i o n l o r a
l a r y n g e a l p r o s t h e s i s is i l l u s L r a L e d in H'iq. b. The
] a f t e r shows dfi upper. r i n g (1) made of so.l .id ti tE-iniLim,
5 whi cb is welded onto n lowui: r i n g (2) made of porous
Litaniuyn- The Lwo rings are sepEtrnled by an area oi
openings (4} l.hat sra i nhended to permiL fixinq by
s u r g i c a l s u t n i c i i . The upper cinq (1) hdi! a c y l i n d r i c al
shape in i t s upper p a r t , then a concave shape, and
HI f i n a l l y once again a c y l i n d r i c a l shape, wiLh the same
diameter as in the upper p a r t.
The tower r i n g {?) has a c y l i n d r i c a l shape oi Lhe same
d i a m e t e r EIS Lhe c y l i n d r i c a l p a r t s of t h e ring {!) * In
15 its lowfii. p a r i , the ring (2) is equipped wi.Lh an area
of openinqs (4) t h a t are inLended to permit f i x i n g by
s u r g i c a l s n t u i e s . H'i na I l y , Llie element, (3) made of
s o l i d LitaniuTii has a c y H n d c i e a l sh^pe of the i;ame
diamoLer as the lower ri nq [?) . The anchoring system is
20 a clatitp system {el Lhe ' V . a b l e t i e " t y p e , l o r example).
F i g um 6 a l s o shows a view of the t r a c h e a l r i n g (60),
with [.he s i l i c o n e Lube (S3) which allows it to be
p o s i t i o n e d with p r e c i s i on near the t r a c h e a . Thi s fi q u re
?!> atso shows Uie o r i i i e c s (6?) p e r m i t t i n g suLurinq of the
r i n g to Lhe byoi.d bone and/or to the base of the
tongue, and also the o r i f i c e s (63) periisiLLlnq 1 c o se
s n t u r i n q to Lhe t r a c h e a.
30 P r o p e r t i e s of the porous t i t a n i um used in the
p r o d u c t i o n oi supports according to the I n v e n t i on
In the producLion oi Lhe support accordinq Lo the
invenLion, the preferred biocompuLible metallic
3!} iiiaLerial is t i t a n i um or a t i t a n i u m - b a s e d a l l o y.
The mieroporons LiLani v:m as d e s c r i b e d in Lhe pa t e n lis EP
193/lHb and Kl* iy404S0 is p a r t i c u l a r l y s u i t a b l e for Lhe
WO 5013/079362 - ?e - PCT/EP2012/073117
produeLioEi of the lower rinq {^}- l"t is biocompat i bl e
find liyhL In wei.yhL, and it has a porosiLy p e r f e c t ly
adapted Lo c o l l c o l o n i z a t i o n.
5 hlxample 'A: Surgical moLhod lur liLLing an a i - t i l i c i al
l a r y nx
The r i n g s , pioaLhes^s havo boon mLEohined and prepared
by Lhij P r o t i p company (Strasbourg, France) ,
For EinesLhesia, tlio exact m e d i c a t i o n Lo bo followed and
t h e dosage are i e i t to the d i s c r e t i o n oi Lhe medical
team.
15 'I'he t.ota t laryngectomy is performed in accordance with
t h e p r i o r ar L. The t r a c h e a l Lree is freed in order to
be a b l e t.o L ii L it some 10 Lo 15 mm,
A tracheostomy o r i f i c e is c r e a t e d 1 yi rcq belovj the
20 proximal s e c t i o n approximately boLween the -3rd and 4th
Lnachoal r i n g s , with secure i i x a L i o n ol the margins
t.heie-jl Lo the s k i n.
After removal ot Lhe larynx, the hoiyhL between Lhe
?5 hyoid bono or base of the tonque and Lhe top ot Lhe
t r a c h e a is measured in order to choose a ring whose
hei qht is Lho most sLiiLabl e ,
I t is thus p o s s i b l e Lo determine the suiLable s i z e of
30 the t r a c h e a l r i n g to be f i t t e d,
Height
111 mm < h < 60 [init
GO mm < h < ''0 mm
S u i t a b l e ring
T r a c h e a l r i n g 50 (mm}
Tracheal r i n q bb (mm)
The t r a c h e a l r i n g {60) is composed ot" poious t i t a n i um
and of s o l i d t i t a n i u m . A s i l i c o n e tube provided with a
3b s i l i c o n e stopper ((SI) J s p l a c e d temporari I y i n s i d e the
WO 20X3/079362 - 77 - PCT/F.P2012/073117
ti tarn urn ilny, wb1 r.b maktiis i I". possi b.l e to align the
trachea and the r J ng and to strenqthen the "join - {Figure
6) *
5 The stopper is mad opening oi Lhe funnel.
WO 2013/079362 - ?'} - PCT/I5P2012/0731;L7
CicaLrJ vatA on and colon.i ? a t i on ;iro allowed to proceed
l o r d period of A Lo 8 weeks before implanting Lhe
EIGLUEZLI l a r y n q e n l p r o s t h e s i s.
5 Imp IanLaLion of Lhe 1 aryngcLtl p r o s t h e s i s (Hi}
HI
before the operaLion, measures aro taken to scan thea
anatomy in order Lo predict. Lhe suitable size of the*
removable part to be fitted (measurement of the
disLance between the upper part ol Lhc tracheal r.i nq
and Lhe base ol the tongue).
Distance from the base of"
Lhe Longne Lo the upper
parL o£ the tracheal ring
h <• .10 mm
10 mm < h < 20 mm
20 mm < h < 30 mm
Suitable remove b Le part
Removable part. 10
Removable part. 20
Removable part JO
Kor anesLhesi a, Lhe exacL medication Lo be followed and
15 the dosage are left, to Lhe discretion of the medical
team, Lining the methods .known in the art.
The paLient is placed layiriq on his back, The
intervenLion .is performed by the oral route under
2 0 genera I anesthesia,
The removable parL is coiisposed of ;i body made oi solid
titanium.
2h In Lhe upper part of the removable pari. Lhere are two
concentri c; llaps. Downward opening of Lhe small flap
permits i nhnlati nn, whi 1 e upwurd openi nq of both llaps
{small l- 1arqe) pertniL s ex ha I a Lion,
30 The removable part is correctly positioned when the
hinqe lllat parL) is against the base of the l.ongue.
WO 2013/079362 ^0 - PCT/KP2012/073I17
The removable par L is maneuvered c a r e f u l l y in order to
a v o i d any i n j u r y Lo the p a t i e n t or Lhe user and any
damage to the removabl e pE^rt ,
!> Before use, it is p r e f e r a b l e to check the i n t ^ q r i L y of
Lhe removable part Eind the c o r r e c t opening oi the
i l a p s , To do t i l l s , torceps or a s u i t a b l e s p a t u l a are
used to apply p r e s s u r e to the small flap i n s i d e the
ptosLhesi s . The small t l a p must open withouL d j f t i e u l ty
10 and c l o s e by i t s e l f .
'I'he opening of the l a r q c f l a p i s checked by opening it
outward from Lhe p r o s t h e s i s , 'I'he l a r g e f I np is pushed
v i a the i n s i d e of t h e removable par. L, Lhat is Lo say by
l!} introducing a s t y l e L i n t o Lhe p r o s t h e s i s v i a Lhe Lower
end t h e r e o f , until an opening of ;ipproxjiiiatcly 45", It
should reLum by i t s e l f t o i t s i n i t i a l p o s i t i o n.
I n a f i i s L sta-je, tho ti t a n i am stopper is withdrawn. If
?[} nccessaiy, the mucosa c o v e t i n g tbR s t o p p e r is opened by
l ^ s e r or with Lhe ^lid ot micro-i nstrumenhs, and Lite
s t o p p e r i s Lh^n withdrawn wi th Lhe aid of forceps by
which it is possible? Lo t r a p Lho t h r e a d f i x e d Lo the
upper part, during placement,
25
By pnLiing on the t h r e a d , it is p o s s i b l e Lo d i s c o n n e ct
i t from Lhe t r a c h e a l ring and remove i t . This force
must be exerLed in the axis of Lhe t r a c h e a l ting by
h o l d i n q it wiLh the aid of forceps in otdc-r to avoid
3f) exert i ncj Lraotion thereon .
The s i l i c o n e stopper is also removed. It is
d i s c o n n e c t e d f torn t h e si 1 i cone t u b e and wi t. heir awn wiLh
t h e aid ot forceps through the r i n g ( o r a l l y ) by p u l l i ng
35 on llto t a b / r o d.
During t h i s opera IJ on, Lh& t. r a d i c a l ri ng must a l s o be
he id so d^ rioL to CKerl. Lract "i on L ho re on .
WO 2013/079362 - 31 - PCT/EP2012/073117
ffliLh t h e a i d of l o r c p p s , Lhe removable par*: i H - placed
on Lhe t r a c h e a l ring n n t i l abutment (cLip s e n s a t i o n } ,
Tho reitiovahlc par.t is correcLly p o s i t i o n e d when Lhe
5 f.I.EiL l a c e of" Lhe parL made of LiLanium [uhere Lhe hinge
"i a p o s i t i o n e d ) is a q a i n s t the base of the tongue and
t h e plane of tho flap:; is s i t u a t e d in Lhe area Lbereoi.
Thus, when the i a r q e flap ia opened, it touches the
tongue.
10
Replace™ent of the removablc part.
The withdrawal of Lhe removable p a r t t a k e s pl;K;e under
g e n e r a l anesLhesia with the aid of f o r c e p s . WiLhdraw
1 r j the assembly o a r e i u l l y , Laking care not to exert
t r a c L i o n on Lhe t r a c h e a l r i n g.
During a change of removable p a r t , the s i l j c o n e Lube
can be wi t.hdravjn aL any monienL fas accessed by the
2 0 surgeon) through t\u: Lraoheoi.omy hoie* Having withdrawn
t h e :3uLure oi. th"i s Lubs to Lhe t r a c h e a , it can be
lowered in the Lrachea :] n o i d e i to recover" jt.s upper
end and e x t r a c t i t ,
' lb The withdraw* I must be c a r r i e d out o a r e i u l l y , faking
c a r e not Lo e x e i l force on the t r a c h e a l r i n g,
A new removable parL is l i l t e d in p l a c e "using Lhe same
proLocol as l o r t h e irri t i EII removable p a r t,
30
WO 2013/079362 - ~i? PCT/EP2012/07 3117
CLAIMS
1, A medicat devi oe for supporting an. implant or
p i o s t b e s i s, c h a r a c t e r i z e d i n "that iL is composed
of two p a r t s , one of which c o n s t i t u t e s an upper
r i n g (1) made of a r i g i d or semi-r i q i d , solid
b i o c o m p a t i b l e m a t e r i a l , and the other of which
c o n s t i t u t e s a lower rinq {2) made of a r i q i d or
s e m i - r i g i d , porous or i n t e g r a l a b i e bi ocompaf.ibl e
m a t e r i a l , s a i d device bei n g intended to r e c e i v e cin
itii.pl LLIIL or a removable p r o s t h e s i s at. the upper
r i n g (1) and Lo bo inst.al 1 ed in situ by means of
the lower r i n q (?) .
?., The medi (;•"! I devi ce for support i nq an implant or
p r o s t h e s i s as claimed in claim 1, c h a r a c t e r i z e d in
t h a t t h e upper (1} arid lower {?} r i n g s arc made ol
a biocompatible m a t e r i a l oi a m e t a l l i c n a t u r e,
p r e f e r a b l y ti t.ani urn or a t1tani um-based a l l o y,
3. The medical device for s u p p o r t i n g an iniplanL orp
r o s t h e s i s as claimed in claim 1, c h a r a c t e r i z e d in
t h a t the lower ring (2) and the upper ring (1)
have openings [A, 62) that allow the device Lo be
s u t u r e d Lo Lhe surrounding t i s s u e s by suzqezy.
4 * The medical device lor s u p p o r t i n g an irnpJ a n t or
p r o s t h e s i s us el aimed i n one ol claims 1 through
3, c h a r a c t e r i z e d in t h a t it also has an el ement
{'.•i) s i t u a t e d under the lower c.inq (?} and made of
a r i g i d or s e m i - r i g i d b i o c o m p a t i b l e m a t e r i a l , said
element (3) c o n t r i b u t i n g to holding the device
a c c o r d i n g to the i n v e n t i o n in p o s i t i o n,
'"i - The medical device lor s u p p o r t i n g an implant or
p r o s t h e s i s as claimed in any one oi claims 1
through 4, c h a r a c t e r i z e d in t h a t the shape oi the
WO 2013/079362 - Tl - PCT/EP2012/Q73117
upper ring (1) is selected in oidcx to receive the
shape of the implant or of the prosthesi n lor
which "if wii 1 provide the support, and i n t.haL
said upper ring (1) is equipped with a means tor
5 anchoring sE±id .imprint or said prosthesis.
G. The medical device for. supporting an implant or
prosthesis a a claimed in claim 5, characterized in
that the anchoring means is selected from among a
10 fixation system providing locking by rotation, by
shri nk-iil or force-fi t assembly, by threading, by
fixing with springs (clips}, by iugs, by hoops, by
countersinking or by interlocking.
.15 1. The inert-i cai device for supporting an implant or
prosthesis as. claimed in claim &, characterised in
that the anchori ng means i s a system of clipping
ox lixing with springs.
20 8. The .medical device lor supporting an implant or
prosthesis at; claimed in any one ol claims 1
through 7, characterized in that the shape of the
lower ring {?.) , and of the elemen-t (3) if need be,
corresponds to Lhe anatomical shape oi the tissue
2b for implantation of the device.
y. The medical device for supporting a tracheal
implant or prosthesis as claimed in claim 1,
characterized in that it is composed oi two paiLs,
30 one of which consLitutes an upper ring (1) made oi
\y rigi d or semi-ri gi d, solid bi ocompati ble
maLerial, and the other of which constitutes a
Lower ring (?) made of a rigid or seini'-ri gi tir
porous or Integra table bi oooiuputibl e ma tftri a I.,
35 s?si d devi co bei nq intended to receive an impl ant
or a r-cmovablc prosthesis at the upper ring [1 )
and to be installed ?n situ on the trachea oi the
patient by moans of the lower ring (2).
3013/079362 - 34 - PCT/EE2012/073117
The medical devi ce ioi support "i nq an Implant or
prosthesis as cl aimed i.n claim 9, r.haiEicLerized in
that, the upper rinq (1) and the element (3) are
made of ;jolic3 t i t ani nin or of an alloy based on
solid titanium, in that the lower ring ['?) i:s made
of porous titanium or of an alloy based on porous
titanium, and in Lhat the ring (1) and the eiesaent
(3) are equipped with openings (4) to permit
fixation by .suturing to the tissues of" the
trachea.
The medical device ior supporting an implant: or
prosthesis as claimed in one ol claims "J through
10, characterized in that I.he upper ring (!) is oi
a qr ooved shape.
A k"i t for surgery of the I ;JJ. ynx, comprise rig the
medi ca\ device as cIaimed i n one ol claims 1
thronqh 11, and a silicone tuba (61} having such
an external diameter that i t can be inserted i nt.o
the lower i.irttj (2) of said device.
Th being able to drop, the second
fjap [\YS) being ab E e to lift., said ifaps (8?} and
[83} beinq rigjdly connected at a hinge region
(85), said flap (83) being able not only to drop
but also to lift together with the flap (W2).
The kit as claimed in claim 13, characterized i n
that sai d device compri ses a f i r.st anchori nq
MO 2 0 1 3 / 0 7 9 3 6 2 - Hr> - PCT/EP2012/073117
•Tie^ns, and jn Lhat sni d removabte element
eorripri net; an a n c h o r i n g means (fife) c o o p e r a t j n q wiLli
^ a i d f i r s t anchori n q means in o r d e r to r i g i d ly
eom^ect s a i d removable e l e m e n t to s a i d d e v i c e,
h
1 5 , The k i t a:; c l a i m e d in c l a i m 14, c h a r E i c t e r i z e d in
t h a t udjd anqhori.fKj is r e v e r . n l b l e , anid removable
e] einBiil he i.ny ah I o to be di ^ c o n n e c t e d from £ai rl
i-tevioe h
10
l i j , ft p r o s t h e s i s i n t e n d e d to be p o s i t i o n e d on n d e v i ce
as ela,iined in one of o l n i m s 1 t h r o u g h 11 in o r d er
to r e p l a o e t h e 1 r t r y n x of" a p._il_ l e n t , c h a r a e t e r l z ed
in t h a t it compri :ies a body m^de of bioeompat-"i b Le
1 5 metal, the upper paid" of which is p r o v i d e d v i l li
two c o n c e n t r i c f i a p s (82, IV.i) , L"he f i r s t i l a p (03)
b e i n g a b l e to d r o p , the second f 1 ap {\\7) b e i ng
a b l e to l i f t , said i i a p s [U2) and (£3) beinq
r i g i d l y c o n n e c t e d at a hinqe r e g i o n (fhr>) , said
? 0 flap (GT) b&inq a b l e not o n l y l.o d r o p b u t a l s o ta
] i ft t o g e t h e r wLLh t h e i l a p {Vi2) , s a i d p r o s L h e s i s
adrii t i e n a \ iy cornyr5 ^i nnj means lor a n c h o r i n g on
s a i d devi co ,