United S ta tes Pa tent [ 1 9 1

Wa runek et a 1 .
l l l l l l I l l l l l l l I l l I l l l l I l l l l l l l l l l l l l l l l l l l l l l l l l l l l l I l l l l l l l l l l l l l l l l l l l l l l
US OO51 1 2640A
[ 1 1 ] Pa tent Number:
[ 45] Da te o f Pa tent:
5, 1 1 2, 640
Ma y 1 2, 1 9 9 2
[ 54] S I LI CONE ELAS TOMER LI NED
PROS THETI C DEVI CES AND METHODS OF
MANUFACTURE
[ 7 5] I nv ento rs : S tep h en P. Wa runek, La nc a s ter;
S o ren E. S o rens en, Wil l ia ms v il l e,
bo th o f NY.
Th e Res ea rc h Fo unda tio n o f S ta te
Univ ers ity o f New Yo rk Univ ers ity a t
B uf f a l o , B uf f a l o , NY.
[ 21 ] Ap p l . No . : 51 9 , 1 55
[ 22] Fil ed: Ma y4, 1 9 9 0
[ 51 ] I nt. Cl . 5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . AOI N 1 /02
[ 52] US . CI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 427 /2; 427 /322;
427 /327 ; 427 /38 7 ; 433/1 68 1 ; 433/1 7 1
[ 58 ] Fiel d o f S ea rc h . . . . . . . . . . . . . . . . . 433/1 68 1 , 1 7 1 ; 427 /2,
427 /322, 327 , 38 7 ; 1 56/307 . 5
[ 56] Ref erenc es Cited
U. S . PATENT DOCUMENTS
3. 445. 420 5/1 9 69 Ko o ko o ts edes et a l . . . . . . . . . . . . . . 260/37
3. 637 . 41 6 l /l 9 7 2 Mis c h et a l . . . . . . . . . . . . . .
3. 7 8 5. 054 l /1 9 7 4 Va n Ha ndel 4. 623. 59 3 1 1 /1 9 8 6 B a ier et a l . . . . . . . . . . . . 4. 67 7 . 1 39 6/1 9 8 7 Feinma nn et a 1 . . . . . . . . . . . . . . . . . . . 523/1 1 1
OTHER PUB LI CATI ONS
Do w- Co rning . New Pro duc t I nf o rma tio n. S il a s tic
Q7 - 47 20 Medic a l GrADE ETR El a s to mer.
W. T. B el l et a l , J . o f Pro s th etic Dentis try. v o l . 54. No .
3. S ep . , 1 9 8 5. p p . 404- 41 0.
[ 7 3] As s ig nee:
S . Pa rker et a l . J . o f Dentis try. v o l . 1 0. No . 2. 1 9 8 2. p p .
1 49 - 1 53.
P. S . Wrig h t. J . o f Denta l Res ea rc h , v o l . 61 . N0. 8 . 1 9 8 2.
p p . 1 002- 1 005.
Ea s tma n Pl a s tic s . I nj ec tio n Mo l ding Ko da r PETG
Co p o l yes ter 67 63, J a n. , 1 9 8 6.
A. Uda g a ma , J . o f Pro s th etic Dentis try, v o l . 48 , No . 1 ,
J ul . , 1 9 8 2, p p . 8 6- 8 8 .
R. G. Cra ig , Res to ra tiv e Denta l Ma teria l s , C. V.
Mo s el y Co . 1 9 8 9 , p p . 542- 544 a nd 547 - 549 .
J . F. Wo l f a a rdt, J . o f Pro s th etic Dentis try, v o l . 53, No .
2, Feb. 1 9 8 5, p p . 228 - 234.
R. E. Og l e et a l . , J . o f Pro s th etic Dentis try, v o l . 56, No .
4, Oc t. , 1 9 8 6. p p . 49 7 - 506.
M. T. S ing er, J . o f Pro s th etic Dentis try, . v o l . 60, No . 5,
No v . , 1 9 8 8 , p p . 602- 605.
Prima ry Ex a m1 ' ner Mic h a el Lus ig na n
Atto rney, Ag ent, o r F1 ' rm I - l o dg s o n, Rus s , Andrews ,
Wo o ds & Go o dyea r
[ 57 ] AB S TRACT
Org a no p o l ys il o x a ne el a s to mers c o mp ris ing c o p o l ymers
o f dimeth yl a nd meth yl v inyl s il o x a nes p ro v ide im
p ro v ed f a c ia l a nd denta l p ro s th etic ma teria l s . a nd a re
es p ec ia l l y us ef ul in p rev enting a nd trea ting c h ro nic
tis s ue irrita tio n due to h a rd denta l p o l ymers . Th ey a re
ef f ec tiv el y bo nded, to p o l ymeric a nd meta l l ic s ubs tra tes
a s denture l iners , o btura to rs . ma x il l o f a c ia l p ro s th etic
dev ic es a nd a p p l ia nc es with a g ro up o f trif unc tio na l
s il a ne c o up l ing a g ents .
1 2 Cl a ims , No Dra wing s
5, 1 1 2, 640
1
S I LI CONE ELAS TOMER LI NED PROS THETI C
DEVI CES AND METHODS OF MANUFACTURE
B ACKGROUND OF THE I NVENTI ON
Th is inv entio n rel a tes g enera l l y to p ro s th etic dev ic es
a nd meth o ds o f ma nuf a c ture, a nd mo re s p ec i? c a l l y, to
ma x il l o f a c ia l p ro s th etic dev ic es a nd denta l a p p l ia nc es
h a v ing p erma nent s il ic o ne el a s to mers bo nded th ereto
f o rming c o mp o s ite s truc tures with enh a nc ed s treng th ,
dimens io na l s ta bil ity a nd el a s tic ity.
Pro s th o do ntic dev ic es , s uc h a s dentures typ ic a l l y
c o ns is t o f a ba s ep l a te o f a h a rd res in, s uc h a s p o l y(
meth yl meth a c ryl a te) wh ic h s up p o rts th e a rti? c ia l teeth
f o r c h ewing , a nd a l s o enh a nc es es th etic s . Dif f ic ul ty c a n
a ris e, h o wev er, due to th e ina bil ity o f p a tients to to l er
a te th e h a rd ba s ep l a te. As a res ul t, th ere is need f o r a
res il ient l iner wh ic h ma y be a f f ix ed to th e denture ba s e
to c us h io n s o f t tis s ues o f th e o ra l c a v ity. I dea l l y, s uc h
ma teria l s s h o ul d be p erma nentl y res il ient, inert, c l ea n
a bl e, s ubs ta ntia l l y wa ter ins o l ubl e, h a v e l o w wa ter
s o rp tio n p ro p erties a nd g o o d tens il e a nd tea r s treng th .
Wh il e s o f tnes s is des ira bl e f o r c o mf o rt, th e l iner mus t
a l s o be s uf f ic ientl y ? rm to dis p l a c e s o f t tis s ues o f th e
mo uth a nd p ermit g rinding o f th e denture p erip h ery to
a v o id c rea ting s o re s p o ts . Fro m a p ra c tic a l v iew p o int,
th e denta l a p p l ia nc e s h o ul d a l s o be c a p a bl e o f f a bric a
tio n under c o nditio ns g enera l l y f o und in denta l l a bo ra
to ries . a v o iding ex tremes in temp era ture a nd p res s ure,
o r th e need f o r s p ec ia l eq uip ment.
La bo ra to ry a nd c l inic a l s tudies h a v e s h o wn th a t f ew,
if a ny, o f th e p res ent ma teria l s us ed a s res il ient l iners
a nd p ro s th etic dev ic es , f o r ex a mp l e, a re s a tis f a c to ry in
a l l res p ec ts . Mo s t c o mmo n s h o rtc o ming s inc l ude ina de
q ua te s treng th a nd el a s tic ity, h ig h ra te o f wa ter dif f u
s io n th ro ug h th e el a s to mer a nd s ubs eq uent s ta ining a nd
deterio ra tio n. Freq uentl y, with th e dis c o v ery o f a p o
tentia l l y imp ro v ed p ro s th o do ntic ma teria l h a v ing wh a t
mig h t a p p ea r to be f ewer o f s uc h s h o rtc o ming s , th e
ma teria l is c o mp ro mis ed due to th e ina bil ity to s a tis f a c
to ril y bo nd th e el a s to mer to denta l ba s e p l a s tic s a nd
o th er p ro s th etic a p p l ia nc es .
Ac c o rding l y, th ere is a need f o r imp ro v ed f a c ia l a nd
denta l p ro s th etic el a s to meric ma teria l s p o s s es s ing p ro p
erties o f s treng th , el a s tic ity, dimens io na l s ta bil ity, l o w
wa ter s o rp tio n a nd to x ic ity, inc l uding meth o ds wh ic h
ena bl e c o nv enient bo nding to mo s t denta l ba s e p o l y
mers with a h ig h deg ree o f p erma nenc e a nd rel ia bil ity.
S uc h ma teria l s a nd meth o ds wo ul d be us ef ul in f a bric a t
ing p ro s th o do ntic dev ic es , s uc h a s dentures with im
p ro v ed el a s to meric l iners f o r p rev enting a nd trea ting
c h ro nic tis s ue irrita tio n f ro m h a rd denta l p o l ymers a nd
f o r c us h io ning s o f t tis s ues ; l iners a f ter o ra l s urg ery,
ma x il l o f a c ia l p ro s th etic dev ic es , l ike o btura to rs f o r de
f ec ts in th e p a l a te, a nd th e l ike.
S UMMARY OF THE I NVENTI ON
Ac c o rding l y, it is a p rinc ip a l o bj ec t o f th e inv entio n
to p ro v ide a meth o d o f f o rming a c o mp o s ite- l ike s truc
ture o f a s il ic o ne el a s to mer, g enera l l y ref erred to a s a n
o rg a no p o l ys il o x a ne, a nd a p ro s th etic a p p l ia nc e by th e
s tep s o f :
a ) a p p l ying a f il m o f a c o up l ing a g ent to th e a p p l i
a nc e, th e c o up l ing a g ent c o mp ris ing a c o mp o und o f th e
f o rmul a :
u
20
40
45
55
60
65
2
wh erein X is meth yl o r v inyl a nd R is - O CO~ CH3
o r O N:C ( CI ' I 3) CH3CH3;
b) drying th e s il a ne ? l m o n th e a p p l ia nc e;
c ) a p p l ying to th e dried s il a ne ? l m o n s a id a p p l ia nc e
a s il ic o ne el a s to mer to f o rm th e c o mp o s ite- l ike s truc
ture, th e el a s to mer c o mp ris ing a c o p o l ymer o f dimeth yl
a nd meth yl v inyl s il o x a nes , th e el a s to mer wh en in th e
f o rm o f a bo ut a 0. 07 5 inc h th ic k s l a b, p res s c ured f o r
a bo ut 1 0 minutes a t a bo ut 230 to a bo ut 250 F. a nd
c ured f o r a bo ut 24 h o urs a t a bo ut 21 to a bo ut 25 C.
a nd a t a rel a tiv e h umidity o f a bo ut 45 to a bo ut 55 p er
c ent is c h a ra c teriz ed by a s p ec if ic g ra v ity ra ng ing f ro m
a bo ut 1 . 08 to a bo ut 1 . 1 2 a s determined by AS TM D 7 9 2;
a S h o re A duro meter in' a ra ng e f ro m a bo ut 1 9 to a bo ut
27 a s determined by AS TM D 2240; a tens il e s treng th o f
a t l ea s t 1 1 00 p s i a s determined by AS TM D 41 2, Die C;
a n el o ng a tio n o f a t l ea s t 1 050 p erc ent a s determined by
AS TM D 41 2, Die C; a tea r s treng th o f a t l ea s t 1 40 p p i
a s determined by AS TM D 624, Die B , a nd
d) c uring th e c o mp o s ite s truc ture a t a bo v e a mbient
temp era ture c o nditio ns .
Pro s th etic a p p l ia nc e a s mentio ned h erein is intended
to mea n p rinc ip a l l y p ro s th o do ntic dev ic es . s uc h a s den
tures , o btura to rs , s p l ints , etc . Ho wev er, th e p res ent
inv entio n a l s o c o ntemp l a tes p o l ymeric a nd s teel ba s ed,
e. g . s ta inl es s s teel , p ro s th etic dev ic es f o r o th er p o rtio ns
o f th e a na to my req uiring a h ig h l y dura bl e, no nto x ic
res il ient ma teria l th eref o r. Th us , th e ex p res s io ns c o m
p o s ite/c o mp o s ite- l ike a s us ed h erein is intended to in
c l ude s uc h rep res enta tiv e ex a mp l e a s dentures h a v ing
res il ient l iners o f th e s il ic o ne el a s to mer ? rml y bo nded to
th e ba s e f o r p ro tec ting o ra l tis s ues .
I t is yet a f urth er o bj ec t o f th e p res ent inv entio n to
p ro v ide f o r a ma x il l o f a c ia l p ro s th etic dev ic e, e. g . o btu
ra to r, c o mp ris ing a res il ient, dimens io na l l y s ta bl e s il i
c o ne el a s to mer c o mp ris ing a c o p o l ymer o f dimeth yl
a nd meth yl v inyl s il o x a nes . Th e el a s to mer wh en in th e
f o rm o f a bo ut a 0. 07 5 inc h s l a b, p res s c ured f o r a bo ut 1 0
minutes a t a bo ut 230 to a bo ut 250 F, a nd c ured f o r
a bo ut 24 h o urs a t a bo ut 21 to a bo ut 25 C. a nd a t a
rel a tiv e h umidity o f a bo ut 45 to a bo ut 55 p erc ent is
c h a ra c teriz ed by a s p ec if ic g ra v ity ra ng ing f ro m a bo ut
1 . 08 to a bo ut 1 . 1 2 a s determined by AS TM D 7 9 2; a
S h o re A duro meter in th e ra ng e f ro m a bo ut 1 9 to a bo ut
27 a s determined by AS TM D 2240; a tens il e s treng th o f
a t l ea s t 1 00 p s i a s determined by AS TM D 41 2, Die C;
a n el o ng a tio n o f a t l ea s t 1 050 p erc ent a s determined by
AS TM D 41 2, Die C, a nd a tea r s treng th o f a t l ea s t 1 40
p p i a s determined by AS TM D 624, Die B .
A s til l f urth er o bj ec t inc l udes o ra l p o s t s urg ic a l de
v ic es h a v ing bo nded th ereto res il ient, tea r res is ta nt, l o w
wa ter s o rp tio n, dimens io na l l y s ta bl e s il ic o ne el a s to mers
c o mp ris ing th e dimeth yl a nd meth yl v inyl s il o x a nes .
Th e el a s to mer wh en in th e f o rm o f a bo ut a 0. 07 5 inc h
th ic k s l a b, p res s c ured f o r a bo ut 1 0 minutes a t a bo ut
230 to a bo ut 250 F. a nd c ured f o r a bo ut 24 h o urs a t
a bo ut 21 to a bo ut 25 C. a nd a t a rel a tiv e h umidity o f
a bo ut 45 to a bo ut 55 p erc ent is c h a ra c teriz ed by a s p e
c i? c g ra v ity ra ng ing f ro m a bo ut 1 . 08 to a bo ut 1 . 1 2 a s
determined by AS TM D 7 9 2; a S h o re A duro meter in
th e ra ng e f ro m a bo ut 1 9 to a bo ut 27 a s determined by
AS TM D 2240; a tens il e s treng th o f a t l ea s t 1 1 00 p s i a s
determined by AS TM D 41 2, Die C; a n el o ng a tio n o f a t
l ea s t 1 050 p erc ent a s determined by AS TM D 41 2, Die
C; a tea r s treng th o f a l ea s t 1 40 p p i a s determined by
AS TM 624, Die B .
5, 1 1 2, 640
3
DETAI LED DES CRI PTI ON OF THE
I NVENTI ON
Th e c o mp o s ite s truc tures o f th e inv entio n a re ba s ed
o n th e dis c o v ery th a t a p a rtic ul a r g ra de o f o rg a no p o l y
s il o x a ne el a s to mer, des c ribed in g rea ter deta il bel o w.
p o s s es s es uniq ue p ro p erties ma king it a da p ta bl e to a
wide ra ng e o f medic a l a nd denta l p ro s th etic a p p l ic a
tio ns , with p a rtic ul a r emp h a s is o n th e f iel ds o f p ro s th o
do ntic s a nd ma x il l o f a c ia l p ro s th etic s , inc l uding l iners
f o r dentures , interim p ro s th es is , tra ns itio na l p ro s th es is ,
s p l ints , s p eec h a id dev ic es a nd o btura to rs . As ma x il l o f a
c ia l ma teria l s th e o rg a no p o l ys il o x a ne el a s to mers ma y be
us ed to c o rrec t f a c ia l def ec ts res ul ting f ro m s urg ery,
a c c idents , o r ev en c o ng enita l def o rmities . No s es , ea rs
a nd eye o rbits , o r o th er p a rts o f th e h ea d a nd nec k ma y
be rep l a c ed by p ro th es es f a bric a ted f ro m th es e ma teri
a l s , a l l o wing p a tients to l ea d a mo re no rma l l if e. I t
s h o ul d be unders to o d, h o wev er, th a t th e inv entio n is
no t l imited to denta l a nd f a c ia l a p p l ic a tio ns , but a l s o
c o ntemp l a tes p ro s th etic a p p l ic a tio ns f o r o th er p a rts o f
th e bo dy wh enev er th e need ex is ts f o r a res il ient, but
dimens io na l l y s ta bl e, inert medic a l g ra de el a s to meric
ma teria l .
Th e o rg a no p o l ys il o x a ne el a s to mers h a v e been f o und
to be es p ec ia l l y us ef ul in c o nj unc tio n with p ro s th o do n
tic a p p l ia nc es , s uc h a s p erma nent s o f t l ining ma teria l s
us ed to rep l a c e th e ? tting s urf a c e o f a h a rd p l a s tic den
ture, eith er bec a us e th e p a tient c a nno t to l era te a h a rd
f itting s urf a c e, o r to imp ro v e retentio n o f th e denture.
Oth er rep res enta tiv e a p p l ic a tio ns inc l ude ma x il l o f a c ia l
dev ic es , s uc h a s o btura to rs typ ic a l l y f a bric a ted f ro m a
denta l ba s e res in a nd a res il ient l ining wh ic h l o c ks
a bo v e th e ma rg in o f th e c l ef t, th us p ro v iding retentio n
o f th e a p p l ia nc e. Oth er rep res enta tiv e c o mp o s ite a p p l i
c a tio ns ma y inc l ude Duyz ing s p l a tes f a bric a ted f ro m a
h a rd a c ryl ic res in a nd s o f t l ining ins erts .
Th e o rg a no p o l ys il o x a ne el a s to mer c o a ting s a nd l in
ers a re c h a ra c teriz ed by h ig h el o ng a tio n, s o f tnes s , but
with dimens io na l s ta bil ity a nd enh a nc ed res is ta nc e to
tea ring . a l o ng with l o w wa ter a bs o rp tio n. Th e el a s to
mers a nd th eir meth o d o f p rep a ra tio n a re des c ribed in
deta il in US . Pa t. No . 3, 445, 420 wh ic h is inc o rp o ra ted
by- ref erenc e h erein. Th e g enera l l y p ref erred o rg a no
p o l ys il o x a nes a re th o s e c o p o l ymers o f dimeth yl a nd
meth yl v inyl s il o x a nes h a v ing f ro m a bo ut 9 9 . 9 0 to a bo ut
9 9 . 9 9 mo l e p erc ent dimeth yl s il o x a ne units a nd f ro m
a bo ut 0. 01 to a bo ut 0. 1 0 mo l e p erc ent meth yl v inyl s il o x
a ne units . Th ey a re a l s o c o mmerc ia l l y a v a il a bl e th ro ug h
o rdina ry c h a nnel s o f c o mmerc e f ro m Do w Co rning ,
Midl a nd, Mic h , under th e reg is tered tra dema rk, S il a s
tic , a nd inc l udes s uc h g ra des o f s il ic o ne el a s to mers h a v
ing th e ma nuf a c turer s des ig na tio n Q7 - 47 20. Th ey a re
s up p l ied by th e ma nuf a c turer a s a two - c o mp o nent kit
h a v ing s ep a ra te p o uc h es des ig na ted p a rts A a nd B . Th e
c o ntents o f ea c h c a n be bl ended to g eth er ma nua l l y to
f o rm th e des ired el a s to mer with o ut req uiring s p ec ia l
eq uip ment, s uc h a s a ro l l mil l . Po uc h es A a nd B c o nta in
th e s il o x a ne p o l ymer a nd th e reinf o rc ing ? l l er, f umed
s il ic a . Th e p l a tinum ba s ed c uring c a ta l ys ts f o r inc rea s
ing mo l ec ul a r weig h t, wh ic h a re a dded to p a rt A o nl y
with o ut th e el a s to mer c uring , a re a l s o dis c l o s ed in US .
Pa t. No . 3, 445, 420. Pa rt B a l s o inc l udes a n o rg a no a c ety
l enic c uring inh ibito r, p ref era bl y a n a c etyl enic a l c o h o l ,
to g eth er with a c ro s s l inking a g ent.
Th e mo s t p ref erred S il a s tic bra nd el a s to mer is th a t
des ig na ted Q7 - 47 20 wh ic h is a c o p o l ymer c o mp ris ing
dimeth yl a nd meth yl v inyl s il o x a nes in wh ic h a p p ro x i
20
45
55
60
65
4
ma tel y 9 9 . 9 5 to a bo ut 9 9 . 9 7 mo l e p erc ent is dimeth yl
s il o x a ne a nd a p p ro x ima tel y 0. 03 to a bo ut 0. 05 mo l e
p erc ent is meth yl v inyl s il o x a ne. Wh en p a rts A a nd B
a re bl ended to g eth er a nd f o rmed into a s l a b o f a bo ut
0. 07 5 inc h th ic knes s . p res s c ured f o r a bo ut 1 0 minutes a t
a bo ut 230 to a bo ut 250 F. a nd c ured f o r a bo ut 24
h o urs a t a bo ut 21 to a bo ut 25 C. a nd a t a rel a tiv e
h umidity o f a p p ro x ima tel y 45 to a bo ut 55 p erc ent S il a s
tic Q7 - 47 2O c a n be c h a ra c teriz ed by a s p ec i? c g ra v ity
ra ng ing f ro m a bo ut 1 . 08 to a bo ut 1 . 1 2 a s determined by
AS TM D 7 9 2; a S h o re A Duro meter o f a bo ut 1 9 to
a bo ut 27 a s determined by AS TM D 2240; a tens il e
s treng th o f a t l ea s t 1 1 00 p s i a s determined by AS TM D
41 2, Die C; a n el o ng a tio n o f a t l ea s t 1 050 p erc ent a s
determined by AS TM D 41 2, Die C, a nd a tea r s treng th
o f a t l ea s t 1 40 p p i a s determined by AS TM D 624, Die
B .
Wh il e ma nuf a c turer s l itera ture o n th e a bo v e el a s to
mers ref ers to th em a s - medic a l g ra de ETR ( enh a nc ed
tea r res is ta nt) el a s to mers - , s uc h l itera ture p ro v ides no
s p ec if ic tea c h ing o r s ug g es tio n th e el a s to mers c a n be
us ed in f o rming c o mp o s ite- l ike s truc tures , s uc h a s p er
ma nent l ining ma teria l s f o r p ro s th o do ntic a p p l ia nc es ,
e. g . dentures , with o ut del a mina ting o r s ep a ra ting f ro m
th e denture ba s e. S il a s tic bra nd s il ic o ne el a s to mer g ra de
Q7 - 47 20, a c c o rding to ma nuf a c turer' s l itera ture. is s ug
g es ted in f a bric a ting dev ic es f o r th e h ea l th c a re indus try
wh ere h ig h el o ng a tio n a nd s o f tnes s a re imp o rta nt, s uc h
a s in ba l l o o ns , enc a p s ul a ting a nd in ex trus io ns . I n a ddi
tio n, s uc h l itera ture o f f ers no s o l utio n to th e p ro bl em o f
h o w to f o rm s tro ng , rel ia bl e bo nds in f a bric a ting c o m
p o s ite s truc tures with h a rd p l a s tic s , l ike th e a c ryl ic s , f o r
ex a mp l e. U. S . Pa t. No . 3, 445, 420 s ug g es ts th e o rg a no
p o l ys il o x a nes a s c o a ting c o mp o s itio ns f o r meta l , wo o d
a nd g l a s s , but a l s o f a il s to s ug g es t, o r p ro v ide o th er
ena bl ement h o w th e el a s to mers c a n be l a mina ted to
h a rd p o l ymer s ubs tra tes to p ro v ide s tro ng , rel ia bl e
bo nds th erewith .
Ac c o rding l y, th is inv entio n no t o nl y rel a tes to th e
dis c o v ery o f a new us e in th e ? el d o f p ro s th etic s f o r a
s p ec if ic g ro up _ o f o rg a no p o l ys il o x a ne el a s to mers , but
a l s o c o ntemp l a tes no v el meth o ds f o r rel ia bl y bo nding
th em to h a rd s ubs tra tes , e. g . p ro s th etic dev ic es to f o rm
c o mp o s ite- l ike s truc tures , with o ut wh ic h th e el a s to mers
c o ul d no t be rea dil y emp l o yed. Th is a s p ec t o f th e inv en
tio n is es p ec ia l l y s ig nif ic a nt s inc e p rio r meth o ds a nd
ma teria l s s uc c es s f ul l y emp l o yed in bo nding s il ic o ne
el a s to mers to a s ubs tra te h a v e no t been f o und to be a
rel ia bl e ba s is f o r p redic ting bo nding p erf o rma nc e with
o th er el a s to mers . Th a t is , c o up l ing a g ents a nd kno w
h o w s uc c es s f ul l y emp l o yed in bo nding o th er g ra des o f
denta l /medic a l el a s to mers to f o rm c o mp o s ite s truc tures
h a v e no t p ro v en us ef ul in f o rming s a tis f a c to ry l a mi
na ted s truc tures with th e s il ic o ne el a s to mers dis c l o s ed
h erein.
Henc e, th e p res ent inv entio n a l s o c o ntemp l a tes th e
dis c o v ery o f a p a rtic ul a r g ro up o f s il a ne c o up l ing
a g ents a nd p ro to c o l s f o r bo nding th e f o reg o ing o rg a no
p o l ys il o x a ne el a s to mers to p ro s th etic dev ic es . Th e s i
l a ne c o up l ing a g ents f o und us ef ul in f o rming p erma nent
bo nds with th e p a rtic ul a r s il ic o n' e el a s to mers o f th e
inv entio n to p ro s th etic dev ic es f a l l with in Fo rmul a ( 1 )
a bo v e. S p ec i? c rep res enta tiv e ex a mp l es o f es p ec ia l l y
us ef ul s il a ne c o up l ing a g ents a re meth yl tria c eto x ys il
a ne. v inyl tria c eto x ys il a ne, meth yl tris ( meth yl eth yl k
eto x imine) s il a ne a nd v inyl tris ( meth yl eth yl keto x imine)
s il a ne. Th e f o reg o ing s il a nes a re kno wn c o mp o unds ,
a nd a re c o mmerc ia l l y a v a il a bl e th ro ug h o rdina ry c h a n
5, 1 1 2, 640
5
nel s o f c o mmerc e f ro m Petra rc h S ys tems , B ris to l . Pa ,
under c a ta l o g ue des ig na tio ns M8 9 8 0. V48 00, M9 220
a nd V5050, res p ec tiv el y.
Th e initia l s tep o f f o rming th e c o mp o s ite s truc ture
p ro v ides f o r a p p l ying th e l iq uid c o up l ing a g ent to th e
s urf a c e o f th e denta l a p p l ia nc e o r o th er medic a l dev ic e
a s is , o r a s a mo re ec o no mic dil ute s o l utio n, e. g . 25
p erc ent by v o l ume in a s uita bl e s o l v ent, s uc h a s meth yl
meth a c ryl a te mo no mer. Fo r bo nds o f o p timum
s treng th , mo re th a n a s ing l e c o a t is p ref erred. I n a ddi
tio n, ea c h c o a ting is p ref era bl y dried bef o re a p p l ying
th e nex t c o a t, a nd s o o n. Mo s t p ref era bl y, th e s il a ne
p a inted s ubs tra te is o v en dried a bo v e a mbient temp era
ture c o nditio ns a f ter th e ? na l c o a ting o f c o up l ing a g ent
h a s been a p p l ied.
S uita bl e s ubs tra tes f o r th e c o mp o s ite- l ike s truc tures
c o mp ris e ma teria l s c o mmo nl y us ed in f a bric a ting p ro s
th o do ntic a p p l ia nc es , s uc h a s a c ryl ic s , p o l yes ters , p o l y
ureth a nes a nd o th er res ino us ma teria l s , a s wel l a s c er
ta in meta l s , l ike s ta inl es s s teel , a l uminum, c o ba l t a nd
c h ro me. S o me o f th e mo s t widel y us ed h a rd ma teria l s in
dentis try a re th e denture ba s e res ins wh ic h c a n a l s o be
us ed in f o rming th e c o mp o s ites . Th ey inc l ude th e a c ryl
ic s , s uc h a s p o l y( meth yl meth a c ryl a te) ( PMMA) , rub
ber mo di? ed a c ryl ic s , v inyl a c ryl ic c o p o l ymers , h ydro
p h il ic a c ryl ic s , f l uid a c ryl ic s , a nd s o o n. Oth er us ef ul
denture ba s e ma teria l s a re th e g l yc o l - mo dif ied p o l y
( eth yl ene terep h th a l a tes ) wh ic h a re a v a il a bl e under th e
tra dema rk Ko da r PETG c o p o l yes ter 67 63, a c l ea r
a mo rp h o us p o l ymer a v a il a bl e f ro m Ea s tma n Ch emic a l
Pro duc ts , I nc . , King s p o rt, Tenn. ; a nd ureth a ne p o l y
mers , s uc h a s a v is ibl e l ig h t c ura bl e ureth a ne dimeth a c
ryl a te p o l ymers a v a il a bl e under th e tra dema rk Tria d
f ro m Dents p l y I nterna tio na l , I nc . . Yo rk, Pa .
Freq uentl y, denta l p o l ymers l ike PMMA c o nta in
p o l ymeriz a tio n ' initia to rs , s uc h a s AB I N o r benz o yl
p ero x ide. Th e p res enc e o f s uc h initia to rs in th e p o l y
meric ma teria l ma y c o nta mina te th e p l a tinum c a ta l ys t
s ys tem o f th e s il ic o ne el a s to mer, a nd c o ns eq uentl y. th e
el a s to mer ma y no t f ul l y c ure. Fo r th is rea s o n it is p re
f erred th a t th e h a rd p o l ymeric s ubs tra tes o f th e c o mp o s
ite s truc ture be in a p rec ured c o nditio n, s ubs ta ntia l l y
f ree o f s uc h initia to rs .
Th e res il ient s il ic o ne el a s to mer p rev io us l y des c ribed
c a n th en be p rep a red a nd a p p l ied to th e s il a ne c o a ted
denture ba s e o r o th er p ro s th etic dev ic e to p ro v ide a n
a p p ro p ria te l iner, p ro tec tiv e c o a ting , etc . B ec a us e S il a s
tic g ra de Q7 - 47 20 wil l c ure a t ro o m temp era ture a s wel l
a s a t el ev a ted temp era tures , Pa rts A a nd B o f th e two
p a rt ma teria l a re ma nua l l y bl ended a t th is s ta g e a nd
a p p l ied to th e dried s il a ne c o a ted s urf a c e emp l o ying
tec h niq ues wh ic h a s s ure intima te c o nta c t between th e
unc ured el a s to mer a nd s il a ne c o a ted s ubs tra te. S uc h
meth o ds a re g enera l l y kno wn by p ers o ns o f o rdina ry
s kil l . Th e c o a ted/l ined p ro s th etic a p p l ia nc e is th en
c ured a t el ev a ted temp era tures to f o rm th e c o mp o s ite,
g enera l l y in th e ra ng e o f a p p ro x ima tel y 60 to 9 0 C. ,
a nd mo re p ref era bl y, a t a bo ut 7 0 to a bo ut 8 0 C. Th is
ma y be p erf o rmed by p l a c ing th e mo l d a s s embl y h o l d
ing th e c o mp o s ite in a c o mp res s ed s ta te in a wa ter ba th
o r in a c irc ul a ting c o nv ec tio n o v en wh ere c uring ta kes
p l a c e o v er a p erio d o f h o urs .
Th e f o l l o wing s p ec i? c ex a mp l es demo ns tra te th e
meth o ds a nd a rtic l es o f th e inv entio n. Ho wev er, it is to
be unders to o d th a t th es e ex a mp l es a re f o r il l us tra tiv e
p urp o s es o nl y a nd do no t p urp o rt to be wh o l l y de? ni
tiv e a s to c o nditio ns a nd s c o p e.
20
25
30
35
40
45
6
EXAMPLE 1
I n o rder to p erf o rm c o mp a ra tiv e s tudies a nd a l s o
demo ns tra te th e bo nd s treng th o f c o mp o s ite s truc tures
a c c o rding to th e inv entio n, tes t denture ba s e ma teria l s
c o ns is ting o f rig id a c ryl ic res in ( PMMA) rec ta ng ul a rl y
s h a p ed h a v ing a dimens io n o f 7 . 5 c m><2. 5 c m><4 mm
th ic knes s were p rep a red. Prio r to a p p l ic a tio n o f th e
c o up l ing /bo nding a g ent, th e a c ryl ic s p ec imens were
l ig h tl y a bra ded with a s a ndbl a s ter o r 240 g rit a bra s iv e
p a p er, rins ed a nd s to red in ro o m temp era ture wa ter.
B ef o re a p p l ic a tio n o f th e c o up l ing a g ent, th e a c ryl ic
s p ec imens were dried a nd c l ea ned with meth a no l . A 25
p erc ent s o l utio n o f a v inyl tria c eto x ys il a ne c o up l ing
a g ent in meth yl meth a c ryl a te mo no mer wa s brus h ed
o nto o ne s urf a c e o f ea c h rec ta ng ul a r s h a p ed rig id den
ture ba s e s p ec imen a s a th in c o a ting a nd a l l o wed to a ir
dry a t ro o m temp era ture f o r 5 minutes . A s ec o nd c o a t
ing o f th e c o up l ing a g ent wa s a p p l ied o v er th e f irs t
c o a ting a nd dried f o r 30 minutes in a n o v en a t 7 0 C.
Eq ua l p a rts by weig h t o f p a c ka g es A a nd B o f Do w
Co rning s S il a s tic Q7 - 47 20 Medic a l g ra de ETR s il ic o ne
el a s to mer were th o ro ug h l y bl ended to g eth er ma nua l l y
o n a p l a te. I ndiv idua l s il a ne c o a ted a c ryl ic s ec tio ns
were s ea ted in g yp s um mo l ds with a s ep a ra ting medium
p rev io us l y a p p l ied a nd th e bl ended el a s to mer p a c ked
a g a ins t ea c h s ec tio n. Two o r th ree tria l p a c king s were
us ed with ex c es s ? a s h remo v ed between ea c h s tep . Th e
mo l d a s s embl y wa s th en c ured a t 7 4 C. f o r 8 h o urs in a
wa ter ba th . Th e tes t s trip s th us c o ns is ted o f 4 mm th ic k
rig id a c ryl ic ba c king with a 3 mm th ic k l ining l a yer
bo nded o v er 5 c m o f s p ec imen l eng th . B o nded tes t
p iec es were s to red a t 37 C. f o r 30 da ys p rio r to tes ting .
Ends o f th e p eel tes t s p ec imens were s ec ured in s er
ra ted g rip s with th e s o f t l ining ta b bent ba c k to g iv e a
p eel ing a ng l e o f 1 8 0 . Th e unit wa s p l a c ed o n a n I ns tro n
tes ting a p p a ra tus .
Th is ma c h ine us es interc h a ng ea bl e res is ta nc e s tra in
g a g e c el l s wh ic h mea s ure tens il e o r c o mp res s iv e l o a ds .
Lo a d is a p p l ied with a c o ns ta nt s tra in ra te by mo tio n o f
th e c ro s s h ea d wh ic h c a rries th e mo v ing j a w. S tres s
s tra in rec o rding s a re ma de o n a c h a rt wh ic h mo v es in
s ync h ro niz a tio n with th e c ro s s h ea d.
Tes t s p ec imens were s ubj ec ted to a p eel ing f o rc e by
s ep a ra tio n o f th e g rip s a t a c ro s s h ea d s p eed o f 30
_ c m/min. Fo rc e p er unit width o f th e bo nd nec es s a ry to
50
55
60
65
c a us e deta c h ment o f th e el a s to mers wa s c a l c ul a ted a s
determined by AS TM D 9 03 a nd p res ented in Ta bl e 1 .
EXAMPLE I ]
I n o rder to demo ns tra te th e p erf o rma nc e o f v inyl
tris ( meth yl eth yl keto x imine) s il a ne ( V6050) a nd v inyl
tria c eto x ys il a ne ( V- 48 00) a s c o up l ing a g ents f o r th e
s il ic o ne el a s to mer S il a s tic Q7 - 47 20, s p ec imen s a mp l es
were p rep a red a c c o rding to th e p ro to c o l o utl ined in
Ex a mp l e 1 . S a mp l es were p rep a red us ing bo th undil uted
c o up l ing a g ent a nd dil utio n with meth yl meth a c ryl a te
mo no mer to p ro v ide 25% s o l utio ns . Co ntro l s p ec imens
were f a bric a ted with o ut s il a ne c o up l ing a g ent.
Fo r c o mp a ris o n, p eel s treng th determina tio ns were
a l s o p erf o rmed o n a c o mmerc ia l s o f t l iner ma teria l ,
Mo l l o p l a s t B , a v a il a bl e th ro ug h B uf f a l o Denta l S up p l y
Co . , New Yo rk, NY. Mo l l o p l a s t B is a p ero x ide c a ta
l yz ed, h ea t- c ured s il ic o ne rubber. Ana l ys is o f th e Mo l
l o p l a s t B c o up l ing a g ent, Primo , s eems to s h o w it is a
v inyl trieth o x y s il a ne in meth yl meth a c ryl a te mo no mer.
Peel s treng th s p ec imens were p rep a red a s f o l l o ws .
5, 1 1 2, 640
7
Tes t denture ba s e ma teria l s c o ns is ting o f rig id a c ryl ic
res in ( PMMA) rec ta ng ul a rl y s h a p ed h a v ing a dimen
s io n o f 7 . 5 c m X25 c m X 4 mm th ic knes s were p rep a red.
Prio r to a p p l ic a tio n o f th e c o up l ing /bo nding a g ent, th e
a c ryl ic s p ec imens were l ig h tl y a bra ded with a s a nd
bl a s ter o r 240 g rit a bra s iv e p a p er, rins ed a nd s to red in
ro o m temp era ture wa ter. B ef o re a p p l ic a tio n o f th e c o u
p l ing a g ent, th e a c ryl ic s p ec imens were dried a nd
c l ea ned with meth a no l . Th e l iq uid bo nding a g ent.
Primo , wa s brus h ed o nto o ne s urf a c e o f ea c h rec ta ng u
l a r s h a p ed rig id denture ba s e s p ec imen a s a th in c o a ting
a nd a l l o wed to a ir dry a t ro o m v temp era ture f o r 9 0 min
utes .
I ndiv idua l c o a ted a c ryl ic s ec tio ns were s ea ted in
g yp s um mo l ds a nd th e o ne p a rt Mo l l o p l a s t B s il ic o ne
p a c ked a g a ins t ea c h s ec tio n. Th ree tria l p a c king s were
us ed with ex c es s ? a s h remo v ed between ea c h s tep . Th e
mo l d a s s embl y wa s th en c ured a t 7 4 C. f o r 8 h o urs in a
wa ter ba th . Th e tes t s trip s th us c o ns is ted o f 4 mm th ic k
rig id a c ryl ic ba c king with a 3 mm th ic k l ining l a yer
bo nded o v er 5 c m o f s p ec imen l eng th . B o nded tes t
p iec es were s to red a t 37 C. f o r 30 da ys p rio r to tes ting .
Ends o f th e p eel tes t s p ec imens were s ec ured in s er
ra ted g rip s with th e s o f t l ining ta b bent ba c k to g iv e a
p eel ing a ng l e o f 1 8 0 . Th e unit wa s p l a c ed o n a n I ns tro n
tes ting a p p a ra tus . Tes t s p ec imens were s ubj ec ted to a
p eel ing f o rc e by s ep a ra tio n o f th e g rip s a t a c ro s s h ea d
s p eed o f 30 c m/min. Th e f o rc e p er unit width o f th e
bo nd nec es s a ry to c a us e deta c h ment o f th e el a s to mer
wa s c a l c ul a ted a nd p res ented in Ta bl e I .
TAB LE I
B OND S TRENGTH kN/m
MATERI AL MEAN S D
7 - 47 20 ( 1 00% V5050) 1 0. 50 . 8 ]
Q7 - 47 20 ( 25% V5050) 9 . 04 1 . 22
Q7 - 47 20 ( I 009 ? V48 00) 1 0. 59 1 . 9 1
07 - 47 20 ( 259 ? V48 00) 1 0. 8 8 1 . 22
Q7 - 47 20 ( CONTROL- NO S I LANE) 1 . 65 . 30
MOLLOPLAS T- B . 1 5 . 07
. N = 1 0 PER MATERI AL
B o nd s treng th tes ting indic a tes th e tena c ity o f th e
bo nd between th e el a s to mer- a c ryl ic c o mp o s ite. Th is
tes t p ro v ides a n indic a tio n o f th e c l inic a l s uc c es s o f a
res il ient l iner.
Th e da ta ( Ta bl e I ) s h o ws th a t th e bo nd s treng th o f
S il a s tic Q7 - 47 20 tes t s p ec imens with c o a ting s o f s il a ne
c o up l ing a g ent is a p p ro x ima tel y ten times g rea ter th a n
th o s e Q7 - 47 20 s p ec imens with no s il a ne ( c o ntro l ) . Al s o ,
Q7 - 47 20/s il a ne c o a ted s p ec imens f a il ed with a th in
l a yer o f th e el a s to mer a tta c h ed to th e a c ryl ic s ubs tra te
( c o h es iv e f a il ure) ra th er th a n by p eel ing o f th e bo nd
between th e el a s to mer a nd a c ryl ic in th e c o ntro l s p ec i
mens ( a dh es iv e f a il ure) . I n c o mp a ris o n with Q7 - 47 20
tes t s p ec imens c o a ted with 1 00% s il a ne, th o s e c o a ted
with a 25% s o l utio n o f s il a ne in meth yl meth a c ryl a te
mo no mer s h o wed s ubs ta ntia l l y no deterio ra tio n in bo nd
s treng th .
Mo l l o p l a s t- B tes t s p ec imens demo ns tra ted a bo nd
th a t ex c eeded th e s treng th o f th e ma teria l , i. e. th e el a s
to mer p o rtio n o f th e s p ec imen rup tured bef o re a c o ns is
tent p eel wa s o bs erv ed a t rel a tiv el y l o w f o rc e l ev el s .
EXAMPLE I I I
An imp res s io n o f th e p a tient s ex is ting up p er o r l o wer
edentul o us j a w is ta ken with th e denture to be rel ined
us ing c o nv entio na l tec h niq ues . Th e unit is inv es ted in a
denta l ? a s k f o rming a s to ne mo del . S uc h meth o ds a re
g enera l l y kno wn by p ers o ns o f o rdina ry s kil l . Af ter th e
30
35
40
45
60
8
g yp s um s to ne h a s h a rdened s uf f ic ientl y. th e ? a s k is
g entl y s ep a ra ted. I mmers io n in h o t ( 50 C. 60 C. )
wa ter f o r a p p ro x ima tel y 5 minutes ma y f a c il ita te s ep a
ra tio n. Th e imp res s io n ma teria l is remo v ed a nd th e
denture ba s e is p rep a red to p ro v ide s uf f ic ient s p a c e f o r
th e res il ient l iner, o p tima l l y 2 to 3 mm in a l l a rea s . A tin
f o il s ubs titute s ep a ra ting medium is a p p l ied to a l l g yp
s um s urf a c es .
Th e a c ryl ic s urf a c e wh ic h wil l c o nta c t th e res il ient
l iner is c l ea ned with meth a no l . A 25% s o l utio n o f v inyl
tria c eto x ys il a ne c o up l ing a g ent in meth yl meth a c ryl a te
mo no mer is brus h ed o nto th e c l ea ned a c ryl ic s urf a c e a s
a th in c o a t a nd a l l o wed to dry 5 minutes a t ro o m tem
p era ture. A s ec o nd c o a t is a p p l ied a nd dried 30 minutes
in a n o v en a t 65 C. - 7 0 C. A bl ended mix o f eq ua l p a rts
by weig h t o f S il a s tic Q7 - 47 20, A a nd B , is f o rmed into
a ro l l a nd p l a c ed o nto th e c o a ted a c ryl ic denture ba s e.
Tria l p a c king twic e with a th in p l a s tic s ep a ra ting s h eet
wil l p ro duc e a n ev en dis tributio n o f ma teria l . Th e p l a s
tic s h eet is remo v ed p rio r to c l o s ing th e f l a s k f o r p ro
c es s ing . Th e mo l d a s s embl y h o l ding th e c o a ted/l ined
p ro s th etic a p p l ia nc e in a c o mp res s ed s ta te is th en p l a c ed
in a wa ter ba th o r c irc ul a ting c o nv ec tio n o v en f o r 8
h o urs a t 7 4 C. Th e a s s embl y is th en c o o l ed a nd th e
a p p l ia nc e remo v ed f ro m th e ? a s k. Th e c ured/bo nded
res il ient l iner is th en trimmed a nd ? nis h ed by s ta nda rd
tec h niq ues .
EXAMPLE I V
Obtura to rs ma y be us ed to s ea l def ec ts in th e h ea d
a nd f a c e c a us ed by c o ng enita l c l ef ts o r s urg ic a l p ro c e
dures . Al th o ug h s urg ic a l rep a ir ma y be th e trea tment o f
c h o ic e. trea tment with a p ro s th es is is o f ten indic a ted.
Fo rmer meth o ds nec es s ita ted mec h a nic a l retentio n o f
th e res il ient o btura to r p o rtio n o nto th e rig id a c ryl ic .
Th e c o ns truc tio n o f a n o btura to r to s ea l a def ec t in
th e h a rd p a l a te o f th e up p er j a w is des c ribed. Th e o btu
ra to r bul b p o rtio n ma y be h o l l o w o r s o l id. Th e j a w ma y
be edentul o us , p a rtia l l y endentul o us o r h a v ing a f ul l
c o mp l ement o f teeth . An imp res s io n o f th e up p er j a w is
ta ken us ing s ta nda rd tec h niq ues . A p o s itiv e s to ne mo del
is ma de f ro m th e imp res s io n. Af ter th e g yp s um s to ne
h a s h a rdened s uf f ic ientl y. th e imp res s io n is g entl y s ep a
ra ted. I mmers io n in h o t ( 50 C. ~60 C. ) wa ter f o r a p
p ro x ima tel y 5 minutes ma y f a c il ita te th e s ep a ra tio n. Th e
mo del is th en inv es ted in a c o nv entio na l denta l ? a s k.
S uc h meth o ds a re g enera l l y kno wn by p ers o ns o f o rdi
na ry s kil l . Th e def ec t is bl o c ked o ut with wa x o r o th er
s uita bl e medium a nd a p l a te p ro c es s ed in a c ryl ic
PMMA res in with o r with o ut p ro s th etic teeth us ing
s ta nda rd tec h niq ues . Th e c ured PMMA s ec tio n is th en
s ep a ra ted f ro m th e s to ne mo del a nd th e bl o c ko ut me
dium is remo v ed f ro m th e def ec t.
Th e ma rg ins o f th e o btura to r ma y l ine th e entire
p a l a ta l s urf a c e a nd termina te a t th e p erip h ery o f th e
a c ryl ic . Al terna tiv el y, th e o btura to r ma rg ins ma y terin
nia te a t a ny p o rtio n with in th e o uter bo rder o f th e
a c ryl ic . Th e a c ryl ic s urf a c e wh ic h wil l c o nta c t th e
l ining /o btura to r is c l ea ned with meth a no l . A 25% s o l u
tio n o f v inyl tria c eto x ys il a ne c o up l ing a g ent in meth yl
meta c ryl a te mo no mer is brus h ed o nto th e c l ea ned
a c ryl ic s urf a c e a s a th in c o a t a nd a l l o wed to dry 5 min
utes a t ro o m temp era ture. A s ec o nd c o a t is a p p l ied a nd
dried 30 minutes in a n o v en a t 65 C. 7 0 C.
A bl ended mix o f eq ua l p a rts by weig h t o f S il a s tic
Q7 - 47 20, A a nd B , is f o rmed a nd p l a c ed into th e def ec t
a nd ex tended to th e des ired p a l a ta l c o v era g e. S ev ere
5, 1 1 2, 640
9
underc uts with in th e def ec t ma y be bl o c ked o ut with
wa x o r o th er s uita bl e medium. Tria l p a c king twic e with
a p l a s tic s h eet between th e rig id a c ryl ic a nd S il a s tic
Q7 - 47 20 wil l p ro duc e a n ev en dis tributio n o f ma teria l .
Th e p l a s tic s h eet is remo v ed p rio r to c l o s ing th e ? a s k
f o r p ro c es s ing . Th e mo l d a s s embl y h o l ding th e p ro s
th etic a p p l ia nc e in a c o mp res s ed s ta te is th en p l a c ed in
a wa ter ba th o r c irc ul a ting c o nv ec tio n o v en f o r 8 h o urs
a t 7 4 C. Th e a s s embl y is th en c o o l ed a nd th e a p p l ia nc e
remo v ed f ro m th e ? a s k. Th e c ured/bo nded res il ient
o btura to r/l iner is th en trimmed a nd ? nis h ed us ing s ta n
da rd tec h niq ues .
Wh il e th e inv entio n h a s been des c ribed in c o nj unc
tio n with s p ec i? c ex a mp l es th ereo f . th is is il l us tra tiv e
o nl y. Ac c o rding l y, ma ny a l terna tiv es , mo di? c a tio ns
a nd v a ria tio ns wil l be a p p a rent to p ers o ns s kil l ed in th e
a rt in l ig h t o f th e f o reg o ing des c rip tio n, a nd it is th ere
f o re intended to embra c e a l l s uc h a l terna tiv es , mo di? c a
tio ns a nd v a ria tio ns a s to f a l l with in th e s p irit a nd bro a d
s c o p e o f th e a p p ended c l a ims .
Wh a t is c l a imed is :
1 . A meth o d o f f o rming a c o mp o s ite- l ike s truc ture o f
a s il ic o ne el a s to mer a nd a p ro s th etic a p p l ia nc e wh ic h
c o mp ris es . in th e o rder indic a ted. th e s tep s o f :
a ) a p p l ying a ? l m o f s il a ne c o up l ing a g ent to s a id
a p p l ia nc e, s a id c o up l ing a g ent c o mp ris ing a c o m
p o und o f th e f o rmul a :
wh erein X is meth yl o r v inyl a nd R is - ~O -
CO - CI - l 3 o r - - O N:C ( CH3) - CH3Cl - l 3;
b) drying th e s il a ne ? l m o n s a id a p p l ia nc e;
c ) a p p l ying to s a id dried s il a ne ? l m o n s a id a p p l ia nc e
a s il ic o ne el a s to mer to f o rm s a id c o mp o s ite- l ike
s truc ture. s a id el a s to mer c o ns is ting es s entia l l y o f a
p l a tinum- c a ta l yz ed o rg a no p o l ys il o x a ne c o p o l ymer
o f f ro m a bo ut 9 9 . 9 0 to a bo ut 9 9 . 9 9 mo l e p erc ent
dimeth yl s il o x a ne units a nd f ro m a bo ut 0. 01 to
a bo ut 0. 1 0 mo l e p erc ent meth yl v inyl s il o x a ne units ;
a nd
d) c uring th e c o mp o s ite- l ike s truc ture a t a bo v e a mbi
ent temp era ture c o nditio ns .
2. Th e meth o d o f c l a im 1 wh ic h s a id c o p o l ymer p ref
era bl y c o ns is ts es s entia l l y o f f ro m 9 9 . 5 to 9 9 . 7 mo l e
-
. I I
20
25
30
35
45
50
55
60
65
1 0
p erc ent dimeth yl s il o x a ne units a nd f ro m 0. 03 to 0. 05
mo l e p erc ent meth yl v inyl s il o x a ne units .
3. Th e meth o d o f c l a im 1 wh erein th e c o up l ing a g ent
c o mp ris es a c o mp o und s el ec ted f ro m th e g ro up c o ns is t
ing o f meth yl tria c eto x ys il a ne. v inyl tria c eto x ys il a ne.
meth yl tris ( meth yl eth yl keto x imine) s il a ne a nd v inyl tris (
meth yl eth yl keto x imine) s il a ne. v
4. Th e meth o d o f c l a im 1 wh erein th e c o up l ing a g ent
is v inyl tria c eto x ys il a ne.
5. Th e meth o d o f c l a im 1 wh erein th e p ro s th etic
a p p l ia nc e is a n a rtic l e s el ec ted f ro m th e g ro up c o ns is t
ing o f a p ro s th o do ntic a p p l ia nc e a nd a ma x il l o f a c ia l
p ro s th etic dev ic e.
6. Th e meth o d o f c l a im 1 wh erein th e a p p l ia nc e is a n
a rtic l e s el ec ted f ro m th e g ro up c o ns is ting o f a denture,
interim p ro s th es is , tra ns itio na l p ro s th es is , a s p l int,
s p eec h a id dev ic e a nd a n o btura to r.
7 . Th e meth o d o f c l a im 1 wh erein th e a p p l ia nc e is
f a bric a ted a t l ea s t in p a rt f ro m a c ured denture ba s e
p o l ymer.
8 . Th e meth o d o f c l a im 7 wh erein th e c ured denture
ba s e p o l ymer is a n a c ryl ic .
9 . Th e meth o d o f c l a im 7 wh erein th e denture ba s e
p o l ymer is a ma teria l s el ec ted f ro m th e g ro up c o ns is ting
o f p o l y( meth yl meth a c ryl a te) , a c o p o l yes ter a nd a p o l y
ureth a ne.
1 0. Th e meth o d o f c l a im 7 wh erein th e denture ba s e
p o l ymer c o mp ris es a l ig h t c ura bl e ureth a ne dimeth a c ry
l a te p o l ymer.
1 1 . Th e meth o d o f c l a im 1 wh erein drying s a id s il a ne
c o a ted a p p l ia nc e a c c o rding to s tep ( b) is p erf o rmed a t
a bo v e a mbient temp era ture c o nditio ns .
1 2. Th e meth o d o f c l a im 1 wh ic h s a id s il ic o ne el a s to
mer is f urth er c h a ra c teriz ed a s h a v ing a s p ec i? c g ra v ity
ra ng ing f ro m a bo ut 1 . 08 to 1 . 1 2 a s determined by
AS TM D 7 9 2; a S h o re A duro meter in a ra ng e f ro m
a bo ut 1 9 to a bo ut 27 a s determined by AS TM D 2240;
a tea r s treng th o f a t l ea s t 1 40 p p i a s determined by
AS TM D 624, Die B ; a tens il e s treng th o f a t l ea s t 1 1 00
p s i a s ' determined by AS TM D 41 2. Die C; a nd a n el o n
g a tio n o f a t l ea s t 1 050 p erc ent a s determined by AS TM
D 41 2, a f ter h a v ing been p res s - c ured f o r a bo ut 1 0 min
utes a t a bo ut 230 to a bo ut 250 F. a nd eq uil ibra ted f o r
a bo ut 1 4 to a bo ut 1 8 h o urs a t a bo ut 21 to a bo ut 25 C.
* * I t a t *
PATENT NO. I 5, 1 1 2, 640
UNI TED S TATES PATENT AND TRADEMARK OFFI CE
CERTI FI CATE OF CORRECTI ON
DATED 1 Ma y 1 2, 1 9 9 2
I NVENTOFKS ) : S tep h en P. Wa runek, et a 1 .
I t is c ertif ied th a t erro r a p p ea rs in th e a bo v e- indentif ied p a tent a nd th a t s a id Letters Pa tent is h ereby
c o rrec ted a s s h o wn bel o w:
Co l umn 9 , c l a im 2, l ine 45, c h a ng e "9 9 . 5 to 9 9 . 7 " to - - 9 9 . 9 5 to
9 9 . 9 7 - - . '
S ig ned a nd S ea l ed th is
Fif teenth Da y o f Ma rc h , 1 9 9 4
Amt- @M W
B RUCE LEHMAN
Co mmis s io ner o f Pa tents a nd Tra dema rks
Arres ting O? ic er