CA2033336A1 - Porous percutaneous access device - Google Patents
Porous percutaneous access deviceInfo
- Publication number
- CA2033336A1 CA2033336A1 CA 2033336 CA2033336A CA2033336A1 CA 2033336 A1 CA2033336 A1 CA 2033336A1 CA 2033336 CA2033336 CA 2033336 CA 2033336 A CA2033336 A CA 2033336A CA 2033336 A1 CA2033336 A1 CA 2033336A1
- Authority
- CA
- Canada
- Prior art keywords
- cuff
- interface material
- tissue
- range
- porous
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
- A61M2039/0261—Means for anchoring port to the body, or ports having a special shape or being made of a specific material to allow easy implantation/integration in the body
Landscapes
- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Biomedical Technology (AREA)
- Animal Behavior & Ethology (AREA)
- Pulmonology (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Biophysics (AREA)
- Hematology (AREA)
- Gastroenterology & Hepatology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Materials For Medical Uses (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Prostheses (AREA)
Abstract
A tissue interface material in a particular form comprises a cuff (12) of generally cylindrical shape which encircles a tube (10).
The cuff (12) is made from biocompatible material having a homogeneous, interconnected structure of the type which can be produced by the replamineform process. The cuff (12) is surgically placed subcutaneously whereby downgrowth of dermal and epidermal tissue is supported by the porous structure of the cuff (12) so as to form a seal which acts to prevent ingress of microorganisms which would elicit a pathological state. The structure is particularly suited to anchoring a conduit (10) within skin layers and promoting a biological seal at the same time.
The cuff (12) is made from biocompatible material having a homogeneous, interconnected structure of the type which can be produced by the replamineform process. The cuff (12) is surgically placed subcutaneously whereby downgrowth of dermal and epidermal tissue is supported by the porous structure of the cuff (12) so as to form a seal which acts to prevent ingress of microorganisms which would elicit a pathological state. The structure is particularly suited to anchoring a conduit (10) within skin layers and promoting a biological seal at the same time.
Description
2~ 3~g ~'0 90/1~636 PCI/Al~'9~/002~2 - ~ r ~ - o - - ~ , c r - - r c e ^ ~ e !_ O c ~ he T nve~ cn Th~s .nver.~,o~i -re ~a~es ;5 ce~v- ces _^~ ~o~ov_d~g ~oe, cu-aneous æccess to the bo~, anc' mo-e p2r~ c~12~
mate. iale ~nc s ~ res a~ cabi~ ~In anchc s~.c`. cev~ ces with~n she boe:v ~or sub5;2~ 21 perio~s Oc .~.e.
~e~ c- ~ ~t ~ o~. o ' ~._ ~ ~
?erc~ ~a~.ec~_~ 4Cce~-- ' 9 ^~ e- . e~ e- f ^. t~.e de!ive-~, lC Oc ~ erape~~ ~ 2s~:~;s, ~~.e ?~CV_sio?. c. D ~ e,, ~r` cz', pne~mz'~-or si:~ 12- .rn~_`~ses or ~he re~novei Oc e~co~es~us'y or exsce:~ously Jr.a~ 2C~UreC r.2~er.z' . The `:leb` 1 ity Oc L;:lo~
access devices (COJ.DCnly -e~'e-~e~ to as c~theters) to bcn.d effec~cively to or ~o ~ w~ CO~ _O~s ~ss~e, 15 pa~lcular'v a. t;r~ de~:na:/e~.derma~ _~er'2ce o~ ex't site, n e f2s~i~r. a.;cloco~s to no~ r2~Ls5-esse~ c~ ~:n~ro~en s.~l .'~c~ ates ecress c' :~c.~e-ne. 'l~_~ds ar~.c. i-~.g-ess of biologica pa~hogen.s.
P~t..o~ en ca' ",~ ~le'- e ~ec i,.';a,..~z' i c.. a the e~ s te 20 leacs ~o ~iscor~. ort ~n^, ~epe-.~,n~ ~po~. 'che seve. ity, a~
aest~etical~v :3~?ieasa-t a~l~ezra;lce and oc~ou~ . Such ~nfectlo~ le~ ~nche~ke~'. o~ if it p-o~esses in a~
ur~co~.trollabi~ ~as~.ior., h'i~ 1 t_acl; ~lor.~ ~he in v~vo po~tion o4 the cathe~e~ ar.c Ca.. le?- t~ sy5te-.i^ ' r ~ectio~ o~
5 i;~'ect~or o' o;le or ~o~e o~ the -ecipier.~s ~:~tern21 orsa~s.
Con~inuou~s a~ 'a~c~ e-~ c-.ec ~.alysis is æ~. exa.
0~ G the~Gpy -ec~ i-.o ch~c._c s~able pe c~aneous a~-esC
2 ~ 3 ? 3 ~ 6 ~ ,0ll5636 PCT/A~90/002$2 _ ~ _ Co~.ri~.~o~c a~ lG;o-S pe- ~one~' c_a'ys~s ~e~u~-es ap?ro~r.,e~e`~ ~ 'itres c' hy~er~o..,_ s__~~ o.. D^ ~..5 ~' ' le~
ar.d be cr~_ned ~rc~. -he pe-i~oneO: cav_~v o,' the pz~ie,. four Simes p~- ~ay. Fl~i~ 2c-ess ~ the pe-itcneum is ~aine~ vi~
a ~-c~aneously posi-ioneA ca~heter. ~etie~-c, wi'~ b~
mz~tzir.e~ o.-, 'kis thera?y ur.~'i s~ m~ as they re~ove-~id~ey '~c.-~ior., a-e g~ve~. a ccr.o. ~ An'~, ~ acec o~
~.lte~r.~ t~.e~cr~es ^~ ~.e~ 'i F~ r~ls O~r ma~..ta'ned c-. co~.ti-,uous a~ z~c-~, pe-i~onea' ~ia'ysis ~c ~0 ~hree ~o ~ou- yea.s z'~h~_ n so~e patie~ts have bee~ o., he t~era?y ~o_ as 1O~5 as lC yeo-s. ~Y.~. site an~ cathete-tunne' _r.fec~ior. a~.c pe-_~snit's 2sso-_a;ec w ~h a poorly main;a~r.e~ exi ~ si ce has bee~ c cause c cor~sidera~le ~o~b~d~ty in these patients who ~-~m.be~ a~o~.im~tel~,~ 50,00 li w~ridwice si~ce l99G.
'.. ~he ~ r a ~en~ has. .he~efo~e, foc~ssed ~or. ~ he de~z~ iec cor.s~ructio- 2-.~ co~?os~on o~ tha; F~-o' the -~e~c_~aneous access dev-ce w~.~. r: ~e~ai~s ~ co~.ac~
wl~h the ~6- s~r. laye-s fo- e~:~e~.ie~ per~o~s Oc t~me when .20 ~he ~e,c~ar.eous acoess device is ~n use.
Particul2-ly the p-lor z t disc_oses var~ous for~s o.
cu~f h~; ch en~a~e the ~e~phe-y o~ ~u~_r.s a~ .e '~e a~ t~e : poir.t where the tubir.~ ~r.~e-s the body in su-h a manne~ as ~o ~: provice a physical ~uf~e~ be~ween ~he s'~ aye.s 2~ .hc 25 entry p^ rt an_ the tub~ r.~ ma~e-ia` ' ~sel~ .
A COl;~ Gn fcrm Oc c~Cc Jr,~e._a:, ~acron ('r~ace ~5ar';1, is ~sclosed ~ ela~ion ~G a relat~ve y COJr.~ie~ "rP-air.e.~"
s~--~c.u-e ~ US ~,2?6,09~ (3O-sa-.~ e; -'`.
~WO90~l5636 PCT/A~90/00~
293~3~6 ~c, ;.6~_,5~ c Lee et ~1) cis~oses ~ re:~ e:v c~r;~te:~ cu'' w~.~c~ c'~_~es ~ a~ '.t ~e ~e~me~ 2 _'S~
a~ e~ ~ e~ w~'' a~ o~ tn~ w.~:c~
s~r.ounds ~;5 ZS to he~s c~c~_- th.e c~ 4 ar.~ .be _r. plzce.
~he ~s: por~ion _r,c~udes a pl~ral_~y o~ Aoles adepted ~o ~_c ~he ir.~row.~. Gf b~Ay ~terial.
T_. c~r~er; practice, cert2i~.'y ~r. Australia, surgEs~s h~.re ~pte~ ~O~ c~.~.F'ici~ s_oA ~
c-.a.ae~e-_st~ C5 C ~ tre eY.?er.Se C. F~ssi~;e ~.e~_ur~ t~ 'or.s 0 '~-~ so~ _ss"e C2-,-'~CZ~'O~.S. Spe~_f_-z:'y, ~ccess .5 V'c a s'l'con cat~.e~e~ w '.~ a ~acror. (~racie r.a~'-) felt c~
Lr~'ace~ ~r. the s~bc~ar.~e.., ~ 5 t_ ~ r~ e~ es r-or ~.e s~. ex~ site. ~ s 'c-2 o' s_~cu~aneo~s ~'~C4 is ~esi~ne~
;o z~cho~ the cathete , ~-cvi~e ~r.~t5~_ ~ ' sz~on ~n~, -heo-e~ical'y, ~re-~en~ e~_~err~c'~ ~owr.~ro~ .. r.~. acc't'c~.c' cu~' is us~z'ly place~ severc` ce~ e-res dee~e. be~oh the s.;_r. s-_rface ~o r~eve~ ea';z~e o_ d_~ysate fro~ the pe~ ~onO~
he ~a~cr fa_lu.-e ~.odes C4 ~hese c~-he~ers r~_ate ~G
so ~ ~issue cor.;p:ic2~ior.s su;h Z5 eY.it S' ~e in~ec~o~ a~.~
cu,r e~:trus'sr. w~.~c~. is ~.y?othes~se~' to be p~irari~y d~le ~o po~- co~.~a~bi,~ty 04 ~he Dacror. cu~ and/o~ e c' ~he c 4~ to 2-eve~.~ s r.uc fo ~tior..
~he Dzc-on fe't cu~f is a wove~ s~~uct~-e z~, 2s 2; suc~, is no~ a t-~ly ~orous s~ruo~u.e ~ t~.e sense use~
this spec_~ic~or..
WO 9011C,fi36 PCr/AI,:901002~ ~
2~333~
~ he ~-ic,- a~ he ' 2~ ~ C pe~c~_ ~z~.e-,~s a~.c subcutaneous cuC~ devicGc z_~o~ler~e~ tt.e~ so~.e a~te~ Os neecs -o be pa~ tc t:~,e rc.cs..y c~ ~he cu f mate-ic`, z~
;eas ~ 2- the c~f f /s~i.. ir.~e.face. ~ ~a?er e-,.itled "Pe_s.ar.e~.t ?erc~aneous De~ ces" ~ Ja~a.5~, 19~; ~ssue (Vol.5) ~ ~RC _ itica'~ Revlews ~n B.oeo.cinee~~r.; provides G
co...p~eher~s~ve summzry, as 2~ th2~ ~a~, c. such dev~ces zr._, ~t pa~e SC~ et ce~ o es ~lcel~ p-~ _C`_lZ-_'J' 10 ~~.e ~,a;~er of per_u~aneouo d~ e-s'.;~ er~c~ior.. ~ os~y is speci.ical y ~_scusse~ he~
~ /US~5/~18~9 ~066~0;?29) ~c Ya~amo~o e~ a' ~scioses a p2-~ cula,, d_s.e~ ,;e cuff s~r~u,e ar.d r.otes thal t~e surfaee cc the cu~ struc~u~e ~ust have tissue seali~s proper~ies "whic~. ca~ b~ co~fe-re~ by (:~ the a-~ch~,er.~ o~
porous, ~issue insrow~:~ romoti~g m~ter~ . s~eh as wove~.
4el~s, 2~C ve'ours, ~ex~ure~ riGlymers~ ~r.~ foa-, c~ sp-~oe-li~e mzte.`zls. (~ ~he s-:r~ace te~..ur_n~ o' t~e sleeve ~a~e-ia' ~y high ene~y bo~oa-dme~t o~ sz1:in~ o~ ~.e~hods:
~3) the att2ch~er.~ o~ ;r.corpo~2tior. 5' ~issue a~:~esive biomolec~les s~ch as lec'ins~". Ya~a~.ato uses ~he te~m "porous~ . a 'oose, brozd se~se.
E~0164~g6 ~o The-~edics d~scloses ~ s~-ucture h2vir.s eavities whl~h a e ~r.~conne~ted ~y a ~o~ou~ pcth . .he ~PO~O~Y" GL s~ch c. s~-;c.~:-e i5 somewha~ c~
~5 Generc~ can be sa_d th,~- the p io~ a-t ~ icztes t~ the so'~ior.s ~5 t~.e p-o~lems c, obta.r.in~ a s~tls aclory a~cho~i~g syste~ fo~ 2 ~e--u~aneous 2ccess 2g33~
WO90~15636 PCT/A~I90/002~' _ ,_ S~ ~e ~ e ~ 6a~ c~ e~:~ty c. ~e^~,e~-~a1 s~ c~u-e of eu'-s use~ z~ ,hC bocv er. l ~ co_~.: fo- s~h cet~es a.,c~ ecse- cor~'e:it~ of c;.e..~c~.' cor,~os_t_-.. t~
che~.~cc! trea;m~-~ Oc the s~i~. cortac~ o~tio~.s Oc those -- dev~ces. Ir. practice s~rseor.s have se.-;e~ fc- relat~velv s~mle s~uc~_res wh~ch ancho- reliably anc are e2sy to ir.s t all, but ~h'ch s-''' h-~ve tis_ue ir~e~ a C ~ . on a~d infect~' or. p-o'~'em~ and S~hG-eCO-e -e-u~ c o ~c.~cn. e~ s ~-ca~e.
~ s a~. c~,ec: c ,,.~ 5 irve~ o~ c~ide ar.
~prove~ ye~ s~r~.~ y co~lst,~c~e~ pere~a~.eo~lC ~~cess dev~`ce wh~c~ bor.~ tc cr b~r.~ w ~ h cont~guo~_ ~issue to ~
s~f'c~er.~ ce~ee zr.- in s~ch a wzy so 25 ~o ove-come ~o at leas~ so~.e exter.~ the ~-c_lems assoc.z~e~~1ith p~ior a~S;
catheters ar.~ the~r ~:~chor~ns sys~ems.
Su~.ma~v c~ ~n~ 'nven~or.
Accor~_n~ so the ~ er.~icn ~here ss ~rov~de~ a pereu.2r.e~ cess c~t~_ce co~?-is_r.s z o.~ ada~ted ~o be passed t~.rouS~ the s'~n ~o def~.e ~ portc' to an~ _ror- the ~0 body anc a po-ous cuf o~ ~iocom.pat~ble mater~21 aro~r.~ the cond~t: s2id b~oco~ t~bie ~ate.~l h~v~ .omogeneous ~r.~e~-o~.~ected porous st~uctu-e o' t~e ty~e which can be p-oduced by ~.e reria~nefor. tech~ ue; s,~ c~_'' a~ap~ed ~o be s~rs,c2!1y placed so as to zn_ho- s2'J csnd~ with~. tr.e body as a resu't c' tissue ~r.~rowth ir.~- sa;~ cu.~.
The po~es o: the cu'' ar~ _r.~e~cor.ne-t~nc ar.~ 2n ar.alosy between '~. s pc-sus sc-uc~ure m~; be m~de, for ` ~090/1~636 PCT/A~9~ æ ~3 3 3 g ~, eY.~, lr, W' ~ t~.e s~u~-.u~e c. ccnre` _G'''5 0~ s~on~5~ bo~e, t~.e t-a~e__~ce~ e s ~~u:;~_~es ~ n ~.is 5 ~c; or. be ~ n.~
cor.st-u:~ed o~ the bioccrpG~~ble 3ate-ia~ o~ .ir.~ a 7G.~lce on w~ h tissue is ~ recte~, rs~rru~e-~ an~ s~ppo~te~.
S~e c~ ~ o'-~he ~ve-~:icn ~ay be man~C~c.~red by establishe~ techniques suc}~. 25 tne repla~.~ne'or~ process in whic~ t~.~ s~eletal st~c~res c' ~a-_r.e .~.ver~e'~ra~es are se~' zc tar~ c.
~ he s~ .e ~ro-~acer b~,~ t:ee -e?'ar..ir.e~crr p~ocess hcs been desc. ~` by ~s c~i~~r.~~o~ 25 C "P:'`OC'iC rb~-.'m~
surface" ~w~. -e ~.A. II-VZi~G~ On O' SmG~ ame.er Gr2~t Pe-amete~s usin~ Re~ia-'neform vas~ui~ os~hes~s" at pase
mate. iale ~nc s ~ res a~ cabi~ ~In anchc s~.c`. cev~ ces with~n she boe:v ~or sub5;2~ 21 perio~s Oc .~.e.
~e~ c- ~ ~t ~ o~. o ' ~._ ~ ~
?erc~ ~a~.ec~_~ 4Cce~-- ' 9 ^~ e- . e~ e- f ^. t~.e de!ive-~, lC Oc ~ erape~~ ~ 2s~:~;s, ~~.e ?~CV_sio?. c. D ~ e,, ~r` cz', pne~mz'~-or si:~ 12- .rn~_`~ses or ~he re~novei Oc e~co~es~us'y or exsce:~ously Jr.a~ 2C~UreC r.2~er.z' . The `:leb` 1 ity Oc L;:lo~
access devices (COJ.DCnly -e~'e-~e~ to as c~theters) to bcn.d effec~cively to or ~o ~ w~ CO~ _O~s ~ss~e, 15 pa~lcular'v a. t;r~ de~:na:/e~.derma~ _~er'2ce o~ ex't site, n e f2s~i~r. a.;cloco~s to no~ r2~Ls5-esse~ c~ ~:n~ro~en s.~l .'~c~ ates ecress c' :~c.~e-ne. 'l~_~ds ar~.c. i-~.g-ess of biologica pa~hogen.s.
P~t..o~ en ca' ",~ ~le'- e ~ec i,.';a,..~z' i c.. a the e~ s te 20 leacs ~o ~iscor~. ort ~n^, ~epe-.~,n~ ~po~. 'che seve. ity, a~
aest~etical~v :3~?ieasa-t a~l~ezra;lce and oc~ou~ . Such ~nfectlo~ le~ ~nche~ke~'. o~ if it p-o~esses in a~
ur~co~.trollabi~ ~as~.ior., h'i~ 1 t_acl; ~lor.~ ~he in v~vo po~tion o4 the cathe~e~ ar.c Ca.. le?- t~ sy5te-.i^ ' r ~ectio~ o~
5 i;~'ect~or o' o;le or ~o~e o~ the -ecipier.~s ~:~tern21 orsa~s.
Con~inuou~s a~ 'a~c~ e-~ c-.ec ~.alysis is æ~. exa.
0~ G the~Gpy -ec~ i-.o ch~c._c s~able pe c~aneous a~-esC
2 ~ 3 ? 3 ~ 6 ~ ,0ll5636 PCT/A~90/002$2 _ ~ _ Co~.ri~.~o~c a~ lG;o-S pe- ~one~' c_a'ys~s ~e~u~-es ap?ro~r.,e~e`~ ~ 'itres c' hy~er~o..,_ s__~~ o.. D^ ~..5 ~' ' le~
ar.d be cr~_ned ~rc~. -he pe-i~oneO: cav_~v o,' the pz~ie,. four Simes p~- ~ay. Fl~i~ 2c-ess ~ the pe-itcneum is ~aine~ vi~
a ~-c~aneously posi-ioneA ca~heter. ~etie~-c, wi'~ b~
mz~tzir.e~ o.-, 'kis thera?y ur.~'i s~ m~ as they re~ove-~id~ey '~c.-~ior., a-e g~ve~. a ccr.o. ~ An'~, ~ acec o~
~.lte~r.~ t~.e~cr~es ^~ ~.e~ 'i F~ r~ls O~r ma~..ta'ned c-. co~.ti-,uous a~ z~c-~, pe-i~onea' ~ia'ysis ~c ~0 ~hree ~o ~ou- yea.s z'~h~_ n so~e patie~ts have bee~ o., he t~era?y ~o_ as 1O~5 as lC yeo-s. ~Y.~. site an~ cathete-tunne' _r.fec~ior. a~.c pe-_~snit's 2sso-_a;ec w ~h a poorly main;a~r.e~ exi ~ si ce has bee~ c cause c cor~sidera~le ~o~b~d~ty in these patients who ~-~m.be~ a~o~.im~tel~,~ 50,00 li w~ridwice si~ce l99G.
'.. ~he ~ r a ~en~ has. .he~efo~e, foc~ssed ~or. ~ he de~z~ iec cor.s~ructio- 2-.~ co~?os~on o~ tha; F~-o' the -~e~c_~aneous access dev-ce w~.~. r: ~e~ai~s ~ co~.ac~
wl~h the ~6- s~r. laye-s fo- e~:~e~.ie~ per~o~s Oc t~me when .20 ~he ~e,c~ar.eous acoess device is ~n use.
Particul2-ly the p-lor z t disc_oses var~ous for~s o.
cu~f h~; ch en~a~e the ~e~phe-y o~ ~u~_r.s a~ .e '~e a~ t~e : poir.t where the tubir.~ ~r.~e-s the body in su-h a manne~ as ~o ~: provice a physical ~uf~e~ be~ween ~he s'~ aye.s 2~ .hc 25 entry p^ rt an_ the tub~ r.~ ma~e-ia` ' ~sel~ .
A COl;~ Gn fcrm Oc c~Cc Jr,~e._a:, ~acron ('r~ace ~5ar';1, is ~sclosed ~ ela~ion ~G a relat~ve y COJr.~ie~ "rP-air.e.~"
s~--~c.u-e ~ US ~,2?6,09~ (3O-sa-.~ e; -'`.
~WO90~l5636 PCT/A~90/00~
293~3~6 ~c, ;.6~_,5~ c Lee et ~1) cis~oses ~ re:~ e:v c~r;~te:~ cu'' w~.~c~ c'~_~es ~ a~ '.t ~e ~e~me~ 2 _'S~
a~ e~ ~ e~ w~'' a~ o~ tn~ w.~:c~
s~r.ounds ~;5 ZS to he~s c~c~_- th.e c~ 4 ar.~ .be _r. plzce.
~he ~s: por~ion _r,c~udes a pl~ral_~y o~ Aoles adepted ~o ~_c ~he ir.~row.~. Gf b~Ay ~terial.
T_. c~r~er; practice, cert2i~.'y ~r. Australia, surgEs~s h~.re ~pte~ ~O~ c~.~.F'ici~ s_oA ~
c-.a.ae~e-_st~ C5 C ~ tre eY.?er.Se C. F~ssi~;e ~.e~_ur~ t~ 'or.s 0 '~-~ so~ _ss"e C2-,-'~CZ~'O~.S. Spe~_f_-z:'y, ~ccess .5 V'c a s'l'con cat~.e~e~ w '.~ a ~acror. (~racie r.a~'-) felt c~
Lr~'ace~ ~r. the s~bc~ar.~e.., ~ 5 t_ ~ r~ e~ es r-or ~.e s~. ex~ site. ~ s 'c-2 o' s_~cu~aneo~s ~'~C4 is ~esi~ne~
;o z~cho~ the cathete , ~-cvi~e ~r.~t5~_ ~ ' sz~on ~n~, -heo-e~ical'y, ~re-~en~ e~_~err~c'~ ~owr.~ro~ .. r.~. acc't'c~.c' cu~' is us~z'ly place~ severc` ce~ e-res dee~e. be~oh the s.;_r. s-_rface ~o r~eve~ ea';z~e o_ d_~ysate fro~ the pe~ ~onO~
he ~a~cr fa_lu.-e ~.odes C4 ~hese c~-he~ers r~_ate ~G
so ~ ~issue cor.;p:ic2~ior.s su;h Z5 eY.it S' ~e in~ec~o~ a~.~
cu,r e~:trus'sr. w~.~c~. is ~.y?othes~se~' to be p~irari~y d~le ~o po~- co~.~a~bi,~ty 04 ~he Dacror. cu~ and/o~ e c' ~he c 4~ to 2-eve~.~ s r.uc fo ~tior..
~he Dzc-on fe't cu~f is a wove~ s~~uct~-e z~, 2s 2; suc~, is no~ a t-~ly ~orous s~ruo~u.e ~ t~.e sense use~
this spec_~ic~or..
WO 9011C,fi36 PCr/AI,:901002~ ~
2~333~
~ he ~-ic,- a~ he ' 2~ ~ C pe~c~_ ~z~.e-,~s a~.c subcutaneous cuC~ devicGc z_~o~ler~e~ tt.e~ so~.e a~te~ Os neecs -o be pa~ tc t:~,e rc.cs..y c~ ~he cu f mate-ic`, z~
;eas ~ 2- the c~f f /s~i.. ir.~e.face. ~ ~a?er e-,.itled "Pe_s.ar.e~.t ?erc~aneous De~ ces" ~ Ja~a.5~, 19~; ~ssue (Vol.5) ~ ~RC _ itica'~ Revlews ~n B.oeo.cinee~~r.; provides G
co...p~eher~s~ve summzry, as 2~ th2~ ~a~, c. such dev~ces zr._, ~t pa~e SC~ et ce~ o es ~lcel~ p-~ _C`_lZ-_'J' 10 ~~.e ~,a;~er of per_u~aneouo d~ e-s'.;~ er~c~ior.. ~ os~y is speci.ical y ~_scusse~ he~
~ /US~5/~18~9 ~066~0;?29) ~c Ya~amo~o e~ a' ~scioses a p2-~ cula,, d_s.e~ ,;e cuff s~r~u,e ar.d r.otes thal t~e surfaee cc the cu~ struc~u~e ~ust have tissue seali~s proper~ies "whic~. ca~ b~ co~fe-re~ by (:~ the a-~ch~,er.~ o~
porous, ~issue insrow~:~ romoti~g m~ter~ . s~eh as wove~.
4el~s, 2~C ve'ours, ~ex~ure~ riGlymers~ ~r.~ foa-, c~ sp-~oe-li~e mzte.`zls. (~ ~he s-:r~ace te~..ur_n~ o' t~e sleeve ~a~e-ia' ~y high ene~y bo~oa-dme~t o~ sz1:in~ o~ ~.e~hods:
~3) the att2ch~er.~ o~ ;r.corpo~2tior. 5' ~issue a~:~esive biomolec~les s~ch as lec'ins~". Ya~a~.ato uses ~he te~m "porous~ . a 'oose, brozd se~se.
E~0164~g6 ~o The-~edics d~scloses ~ s~-ucture h2vir.s eavities whl~h a e ~r.~conne~ted ~y a ~o~ou~ pcth . .he ~PO~O~Y" GL s~ch c. s~-;c.~:-e i5 somewha~ c~
~5 Generc~ can be sa_d th,~- the p io~ a-t ~ icztes t~ the so'~ior.s ~5 t~.e p-o~lems c, obta.r.in~ a s~tls aclory a~cho~i~g syste~ fo~ 2 ~e--u~aneous 2ccess 2g33~
WO90~15636 PCT/A~I90/002~' _ ,_ S~ ~e ~ e ~ 6a~ c~ e~:~ty c. ~e^~,e~-~a1 s~ c~u-e of eu'-s use~ z~ ,hC bocv er. l ~ co_~.: fo- s~h cet~es a.,c~ ecse- cor~'e:it~ of c;.e..~c~.' cor,~os_t_-.. t~
che~.~cc! trea;m~-~ Oc the s~i~. cortac~ o~tio~.s Oc those -- dev~ces. Ir. practice s~rseor.s have se.-;e~ fc- relat~velv s~mle s~uc~_res wh~ch ancho- reliably anc are e2sy to ir.s t all, but ~h'ch s-''' h-~ve tis_ue ir~e~ a C ~ . on a~d infect~' or. p-o'~'em~ and S~hG-eCO-e -e-u~ c o ~c.~cn. e~ s ~-ca~e.
~ s a~. c~,ec: c ,,.~ 5 irve~ o~ c~ide ar.
~prove~ ye~ s~r~.~ y co~lst,~c~e~ pere~a~.eo~lC ~~cess dev~`ce wh~c~ bor.~ tc cr b~r.~ w ~ h cont~guo~_ ~issue to ~
s~f'c~er.~ ce~ee zr.- in s~ch a wzy so 25 ~o ove-come ~o at leas~ so~.e exter.~ the ~-c_lems assoc.z~e~~1ith p~ior a~S;
catheters ar.~ the~r ~:~chor~ns sys~ems.
Su~.ma~v c~ ~n~ 'nven~or.
Accor~_n~ so the ~ er.~icn ~here ss ~rov~de~ a pereu.2r.e~ cess c~t~_ce co~?-is_r.s z o.~ ada~ted ~o be passed t~.rouS~ the s'~n ~o def~.e ~ portc' to an~ _ror- the ~0 body anc a po-ous cuf o~ ~iocom.pat~ble mater~21 aro~r.~ the cond~t: s2id b~oco~ t~bie ~ate.~l h~v~ .omogeneous ~r.~e~-o~.~ected porous st~uctu-e o' t~e ty~e which can be p-oduced by ~.e reria~nefor. tech~ ue; s,~ c~_'' a~ap~ed ~o be s~rs,c2!1y placed so as to zn_ho- s2'J csnd~ with~. tr.e body as a resu't c' tissue ~r.~rowth ir.~- sa;~ cu.~.
The po~es o: the cu'' ar~ _r.~e~cor.ne-t~nc ar.~ 2n ar.alosy between '~. s pc-sus sc-uc~ure m~; be m~de, for ` ~090/1~636 PCT/A~9~ æ ~3 3 3 g ~, eY.~, lr, W' ~ t~.e s~u~-.u~e c. ccnre` _G'''5 0~ s~on~5~ bo~e, t~.e t-a~e__~ce~ e s ~~u:;~_~es ~ n ~.is 5 ~c; or. be ~ n.~
cor.st-u:~ed o~ the bioccrpG~~ble 3ate-ia~ o~ .ir.~ a 7G.~lce on w~ h tissue is ~ recte~, rs~rru~e-~ an~ s~ppo~te~.
S~e c~ ~ o'-~he ~ve-~:icn ~ay be man~C~c.~red by establishe~ techniques suc}~. 25 tne repla~.~ne'or~ process in whic~ t~.~ s~eletal st~c~res c' ~a-_r.e .~.ver~e'~ra~es are se~' zc tar~ c.
~ he s~ .e ~ro-~acer b~,~ t:ee -e?'ar..ir.e~crr p~ocess hcs been desc. ~` by ~s c~i~~r.~~o~ 25 C "P:'`OC'iC rb~-.'m~
surface" ~w~. -e ~.A. II-VZi~G~ On O' SmG~ ame.er Gr2~t Pe-amete~s usin~ Re~ia-'neform vas~ui~ os~hes~s" at pase
3;5 i-. vasc~'e- G a~t nG, e~.. Jchr. Wr~gh~, P~S.G., Inc., Mas~acnuset~s, 383). Su-h 2 5~C2c' ' S ~t~C~ ~n the sa~e art~cle ~o divide sace 'n~c ~wc ~nte~pene~rat~n~ networks, .
eac~. h~vin- pores an^ i~e-co~ne:;~ons betweer. tne po~es oÇ
essent~ t~e same c~er.sic... mhe re~l~m,nefo~^m process : uses the ric:o po~ous s~eleta~ s~-.~c~ure o~ seleoted ma~.r~e ~pecies as e ~em~late ~o ODt~ ' n ~e desire~ ~orous netwo ~ b~J
the p~ocess c_ ~ ng the void spaces in the s~eleta structu~e ~ith the ~esire~ biccorpat~_'e materizl an~ the~
etchi.~g away the s~eletzl structu-e itsel to leave only the b~ocomp~t'ble mate~ial. T~e process is charac~erised b5~ ~s abil;ty ~o p~oduce po~o~s struc~ures o~ the abo~e des_~ibed type. ~h~oughout th.s spe~ificatic~ t~.e use o' the ~erm "homo~e.~eouc, i~te~-~n~e~tec ~o-o~s s~.uc~u~e1~ h_~l be use~
to denote a pcrous s r~oture ~s Ges~~ibe~ b~ W~._te a~
2~3~33~
WO 90/1~636 PCI /~1~90~002~2 ~a~,2~ ~ cc b~ r"- r~ .ce- ~ e E~ ~ia~ .e~or~ ~. oc~s~ .
A ~".o~c..i~ ar:e c' c se~~ior. tho~ ch 2 '~00 n!.`C-C., po e s`7e 5~-UC-U~c ~o~ce- b~ ~he -C?~ar.~r.e~G ~r. p~ocess i~
re~ro~uce~ in ~ig . 3 o' th~ s svecif c I or. . ~he seade- of _5 spec~ _ca~c~ s eiSO .e e.rer to cther i' 'ussra~o~.s c' su-!~. porous s .r~c~u-es pro~uce by the :e~ r.e~o:- pO ocess a5, fot~ e~a~ ,le, _17us~-a~e-' r ~ pa~e ~75 o~ ~ om6~e-_~5, Yo ', ~, J~~ 1, h~he ~e ~ 2 ~ . ~c~ ~ 3 ~ ~ c ~ . c ~ ~--c ~,c ~he p~ecurs~. ..a;e-ia: ~9 showr ~ sec~.G:I ar.d -als~ ~c ~ ~ç.
0 G~ page :~ c' -~*mz~~ ~, " V~ ,ul~ 198~ e s .-..uc~_-es a~ e avzilabl e corr.me~ c_a' 1~ ~-or.. I:~te-pore 'r,7;erna.~0nc' r.e. ir. _~ inC, ~a'i orni~, Ur.-ted S;a;ee c.
Ame- ' ca .
Pre~e~ably, the rorous cu ' is :~a~e o~ me~ cal g~ade 15 s ~ ., i cor.e rubDe~ _s pos _ . ~ o ~.d e ~ the- subeu ,.ane~-:s 1~
(u:~der ~h6 s~ .) or ~e.~u~aneous'y (I.hrough tr.e s'.;ir.` t~ereby c;low~3 ~bro~ a-.~ eice-.~a' ~ssue i~Lrow:h ir.~o ~he pores r~e~ 5tir.s i-,~ia..: ar.'y:osic a..~ t_ssue slasil~~y ~eeded ~o preYer.~ ~r.fe_~ on o the s~ro_n~_~.s an~ u~er!yir.s tisseC
a-,d~c- avulsion zrd ex~e~ o-isa~'c. o~ the c~ r~, I~. a f~-the. preferre~ f~r~, the porous c1.~ is ~ad~
fro~ hyd-oxyapa.~te or t~?niu~ .
~ alte-n~ive pre.erre~ fo,m, the p5-OUS C__c is 3ace from ~ ocompat~'e ma.er.e~ com~.is'~. one D- more c' s_'icone rubbe-. se~ ri~ c'y~-e~.ar.e or o~h.~ so'~, elastome~_c ~.a~e~
The s~7e z-.d d~s~ga o~ l~.e c~C~ ~ - be ~e~ender.~ ~pO,.
WO 90/~636 PCI/A~O~O`~ 3 ~he si-e c~ ;h.c co~.dui ~ ~~Gns ,-essi-., tr~e skir.. .Io~eve~ e l~nç~ ' ran~e ucu~: y f-o~. or.e to sever~ times t:~e ei:ter~a' ~ 2me~er o' ~h~ co~ he t;.,ck~ess c~ ~he ~-,c, ~2~.~ b~ vzr~a~'~e dever.~ ~u upon po-e si~e and 2pplica~c-..
Pore s ,ze ic se ~ected such t;hat :t wili a' low in5sow r.
asl~ nur~~rin~, Of ~:` b~rcbizsts which lzy down colla$e?. fo~
'i~ro~s t~sue to ar.ky1ose the cor.du t ~hich the ?orcus mater~al sUsro~Ac.
Prefer2blv, ~he pore size o the cuCc (tha~ ic. tr.e averz~e ~ia~.e~er c the --egul2rly shape~ i..te~co~h~ ~ir.-; pore~ w~hin the c~ te-ia!) is ....... the ranse o' 3v t~ 5~0 u~ o~e pre'erc~'y the pcre size of ~he c~ff m~er~G! !ies ; ir. the rance ~5 tc ~00 ~ o~.etr~ ar.~ yet mo.e p-efe~ab's~ in the ranse 100 to 22~ ~ic~ometres. A. p~-~icu12~ pre~e-re~
fc-~ of the ~nve~ o~ has ~ po-e s~2e o' ~pproxi~ate,y 2 c-o~e ~,r~5, Tt ~ 5 21so ?refe rec ;hc~ the orosi~y o~' th.e CUCc (tha~ is. the f~a-~o. cc bul~ vo~ume o~ the ~ate~ial cc~u~ied bv vo~ds~ .s g~ea.e~ than ~C~. ~ore ~referab'~
~s desired tha~ ~.e pc-os'ty o~ the c~ff ma~erial l~es _r. the san~e ~$ to R'i%.
P~efe~a~' y where elasto~er~ mate-ia7s are used fo- the bio~o~pa~ble mate~ial ai~ comp'iance is in the range o' 2:
~o 8; o- ~.o~ pre~e~a~y ~ to ~O Sho~e A po~nts ~ased on s~2ncar~ ~ST~ ~es;s, Fio-e pre~era~ls~ _n the ran~e ~5 ,O ~e S~.ore A po_nts an~. ye' ~Dre p~e_erab'y, zippro~.~mate'y 4 Shore A points.
W090/t5636 PCT/AU90/o~ 323 3 6 e~_rs~ar.ceC ! ~.c :r~e.- co ~c~ves o~ ~c~ve s~
~ p~o~e t.re ~ ow~.. ~ . ss~ 2~ nh.~b~ th~
grow~h. c~ bac~e -_ ~.a, b~ cs~oc 2te~ e s~~~G~es c ir.te~s~ices cf ~h,~ po~es. ~ ssue ç;ow~h p.omoters w~ll ~.r:uce t~e che~.o.~ot_c ~ac~o~s suc~ cs p ateie~ de-'ve~
~row~h fa^~
The su:face o~ tr.e ro-es can be ~ .'ie~ tc ~m~rove t~ n~.ate ~_~z-~ t~,~ e~ , r! b~ e~ . a~
~.~c oP~ '; t~ S-- ~.ec~.~e~.~ w~:. ~olys yccl c 2ric.
~ab~le su~s~ar. es s c~. as gro~ h 'CctC.5 car. be p_ace~ h'~
~he ~o;res ~. 2 s~c_~ing ~eium s_ch as c coi'age~ oe~l.
Rob~st b~olos~Cc' 2:~1ve s~ec~es a~c ~bs~ces i~ te:~s o' the_~ ab l i ~y . o ~ ths;2r.~ subsecuent c;e~.~cc~ pu'ation . ~y be ~-zfted 'o o~ h'~'~.' r. th.e ~lyme~ faee by a v2~ie~y o~ che~.ical tec;~ es suc~. ~c ~iasmc ~r~'t_~g o~
incorporz~io.. ~ -h~ po yme: F~ o c~'f ~cr.uC2 - ~ e.
G.~f~r.c ~c~ e.c~~,~as~ covclen~ or ~o-e 'a~ile ~nter~olecula~
zt~rac~ions su_:~ zs t.~ose ir.vo!v~ .v~:osen bor.~ ns, ~ipole inte~ctions ar.- Var. de~ Waals 4Orces.
I~. a fu~r.e- ~oz~ fo~. Oc ~he _~ven~ion the~e is p~ovi~ed a method o~ ~o~ing a CU44 from bioco~p~ti~le ma~e-.~' for enclos r.~ ~ co~ for ~he pur~ose oÇ a~chor~s ~ai~ con~uit w ':~_n s'i~. laye-s an~ prC~Ctir.s a biOiosicâi sea'j S2~ me~hc_ cor.p~ ormi~ 2_~ b~oco~pztible ~ate-ia' ~r. s~oh a ~an~e~ thz~ ^ s st~ct~Ye i~ludes plurallty o~ po~es w~ h are h shly i~.tercon~e~te~.
WO 9~/1!;636 . PCrtA U90/002~2 2~333~
~ -e~e-~'y saic` ~,e;hc~ ~c_~cee us~ Or .~e repla~ e'or.~. p-oces5 ~c p-od~-e sc_~ b~ooompa~ie ~.z;e-_G'.
~ .~ ye~ fu~s;r~e~ b-oa~ fo-.-. o~ ~he ~ve.~~~c~ t~.~.e _ ~rovi~e~ ~ .issuC '~.te:~ce whe-eir~ a ~ssue se~l is 20~e~`
betwee:~ a CO~`lit anc' sl~r. i~.te-,ace, s~ tissue ~n~e-.ace co~.p-_s rg b_~com~zt_~'e ~a~e~ial ~ade ~y -he replar.inefc~~.
process whe~e~y ~ ~tr~ c~re .~a~ing con.-o;led porosity ~d z r~ornpliar;c~ ~n ~ ~rese~ecte~ -zn,e ~ t_ine~.
~ ~e~er~b'~ sa ~ poroci-y (.:.a~ i~, th~ fr2ct_0~ c^ '~
volu~.e~c~ t;~e rzse~_a' occupie~ by voids) ~s çre2le~ ~h2-. ~C~
ar.d r~ore ~re~erG~ly i~ e rar,ge 2'% .o 85~ eCe-ablv wr.ere elas-o~.e~c mzleria's ar~ used for ~"e ~ cco~.pz~ib'e m~e~s z`
sa~d cor,~l'zn~e i5 _n the rar.g_ o' ^: lo 6~ S~.o.e A ~oi~ts based on s.~n~zrd AS-~ tests, r.o-e p-e ~-c~ e ~cr.ge ~5 to 45 Shoro A ?oi~s an~, ~e~ ~ore ~.e~e~~ , a~pro~.imc.oly ~0 Sho~e ~. ~c~ s.
3 e R ~ 5 . . ~ Gh ~ c s '~; o~Ge- the~ .~.e i?.~ea-io~ ~a-~ oe mor~ reaci'~
unàe-s~ooc ard ps- .nto pr~:'ic21 e''e-:, re~e.ence w_l: no~
be ma~e ~_ ~he accompanying drawir.gs in which:-F 5 ' ~s 2 sc~e~a~'c view o' ~ pe~-utc~.e~ls zccess device acco~din~ to one embodimen~ o~ the inventio~ ~laced subcutaneo~sly, an~, Fi~ 2 is a view s~r.'l~ ~o Fi~re ; wi~h. the perc-~;z~eous access ~evice p~aced percu~aneo~s'v.
F~s ~ is a photomicrograph c' c ^~ m_c-cn po~e s'~e str~c~ure of Pn embodimen~ G~ the st-uc~ e zec- b~ e inve-.~ic...
~'0 90/l~636 PCr/AI.9~/00'42 2Q333~6 _ ~ s ~ c ~. c ' r. ? r e ~ 2 ---c r _ - - 5 r~
-~ 7. i S;'~0W~ G p~~C`.~;cneO~'` access ~evice co7r,~~~s_n c c~r.d~ 1 O o4 ar~rop-ia e cor~os- t~o:~ a~ e~ ;'^.. FG:
~e-~tone..; di21vs.6, 40r e..~mp' e, t~.e cathe ~e~ ~ s m~:~e 6, or s :~.or~e 5 1 ~-one ~ 25 ~r, o~ rsi_e d~amete~ etwee~
a~o.~ 7 .n~ llimetres ~ The cc~ passes th-ou5h an.
ir.cisio.. :; .r. th~ s~ c th~ b~y ~ssue 1~ Ir. the case o~ E)e. i ~or.ec;.L ci~lys s ~ ~ is der- i ~ed ~o ' ea~ hD oub~
O .~ ;a~e ~D- 2s io-~c ~s. poss~_1e_ f~ ~rr,~ OC~;s, ~r.cr.+~ or e~e.~ yea. s .
~ rO reme~ ~r. pla~e, the tube ~ C re~,u re~ ~G be ~eliG~'y 2~-h_-ec' wit~. r, ~he bo~ issue 1~ ~c~ ~his p~ ose z 'p'-_ _US C'_'4 ~ is 2~ .ache~' tc the pe. iphe-y o4 t.~e tube c;;
.Loc2~.~or~ mme_iately be_oh ~he s,.~ r. su~ ~ce. ~ no~-?orous sieeve 15 w~ic~ r.~eS-,a:l ~ connec; e~7 O t.~e ~si~e s~ ace 9~ ~he ~~o~s c~ s pe~-mzne.~'y co~.r.eete~ ~c .he o~e.-s_rC ce o t~ be :~ b; ~c ~he s~e? o' ~'_ ..~ c~.
be pe--or~e~ c~ ;he ~ ~e c' mæ~.~f2ct~re c' tube ;0 o~ i. c2e.
w pe-.ormeA d~ he o?e~ra+io~. ~o ~nse-~ the tl~e ~ ir.tG
the ~o~y t~ssue 1~" The no?.-po~us sleeve 15 se~ves to ~solate the pGrOUS s~r~_tu-e cc the cu~ ;2 '-o~ t~e slue Porous ma~e~~al from w~'ch the generally ~ylin~i-ica' CU5' ~ is ~,ade ~s ~,iocompc;~ble ma~eric! const,~e~e~ by the re~ia~lr.e'or~ ~r~cess so as .o ~cvi~e the blocompa;lble ma+~er'a' with ~ ho~oçe~eous ~.terco~-.eeted porous ~ruc~ure.
~he p.ocess itseiC ~s ~esc-ibe~ c~ examp'e, e-~ e ~?r~ c^~-o2-~ ?. z +_c;e bv Whi~e~ R.~ e~ ~:
. . ~ . .
W090/1~636 ~Cq~90/~02~2 2a3333~
en~le~ "Re~:a~. ne,o~r,: '. Ne~ ocese ~c~ P~epa~i~ Po.o-~s Ce~2.~ . Me~z:, ~nr ~cly.m~ . ~~OS ~he. - ~z~e._zls".
~ he ~ec~ e is use~ fo. du~'ic~~ir.s the microstr_^t-~re of carbcn2te s~eletc' com~or.er.~C ir. cerz~.ic, met~' or ~G'yme- ~a;e~ials. ~he ~ocess 2:10ws ccr.trol of pore size and the s~ze o' the l~te-connec ~ion between ad~acent pores. ~he process is p2-ticu' 2~ se'u' whe~e relat~vely ~lr.i~o~ p~re sl_e ~ pe--.ezb 1~ cc.~.e~
since c~-~o~ate skeletc st-_-.u es havir~ s~ac~.
cha~2cte-is-lcs z-e cc~.~.c~. ~ na~_-e.
Fo- pe-itonea' ~_clys~s, the heish~ (dl~.er.sio~ A ~n F_5. 1) of .he gene.~ y c;' nc~~cz' c_~c ~trl-c~ e is i~ the rzn~e Cf C.5 to 2 cer.time -es. Dimersion B i~ F's. : (the thic~ness o~ the ~oro~s s'~uct~re o' the c~') is i-. the ~znge O.S mi:''metre to ~ r,~l'imet~es. ~hese d~mens on6 vary accord~r.~ to the phyciczl size G' the patier.- or ar.i~l, the ~oy .oc~.ic~ o w~.^c~ e 'C ~s to be ~r~se~te~ ~n~
the pa-~_cula- tas~ which is ~o be per~o:me~ by the ~ube 10.
Fo- uses othe- thz~ pe~i~cnea' di~lysis, gener2~1y the ~imensior. P. wi' l be in the ra~gt 1 to S tin~es the outs~de di~meter o~ the tubla7 element e:~c 1 osed ~y the c~;f.
Di~ensior~s generally ~^e sele~te~' c~ d~ to the pz. r.cu;z-2p~ ic~tio:~.
~ :~ the su~cu.aneous a-~an~e~er.~ c Fi~ he c_ff 1~
is id~ally io~ated wi~h~ n ' centim.e ~, e o' t~.e sur.aco o~ the ski:, 11. i.e. the to~ of the cu^f '2 a~ ~l'us~rate~' is wi;h_r.
ce-.timete o' the su~^Cc~e CL Ihe s~ ~r. :.
2~3333~
~''" 90~1S636 PCI/AU90/~0242 ~`n6 i~.s~de diA~,ete- c.~ ti~e cu~ is selected to ~.c~c~.
the o~e~s'de d~ .r ~c- c~ I 'r.e tU~C '~'~.'s cl~r,er.s~c~
va--~ a-co~ ne t2s:~ w,._r;~ hc .'.~b~ C~ is ~c pe~ G.-r he po-e s,-e withl~. the porou~s s- ~c ~ure of the cu. ' S ' ~ ~ wn~ -o~.ceA GCCC~di r,g ,0 tr.e , e~ic~ e'orm process, ~ s rq~;tivel~J~ con~ nt, ucu~ . e se~r.c~ rio.C~ ur.
0~ of ~che ave-~5e p~re si~e c' the ~ ~r~:c ~ure .
Ave~G~e ;?o~e s ~ ze c~ e ~e'~ ec ' e~ e ~ .~r.ge ~C to ~OC Jr.ic~c~. . ~x~e-imer.t~' res.-' T.5 ~0 ea;e s-~g~est q5 10 ~o 3C~ ~.cror~.s c a p-~fer~ed -~o~^e si2s ranse C.orn ~;-~lch to select w;~ ~s~ :C0 ~o .~2C r~ c~or.s _s the rn,os ~ c~esired .2n~e from wr.lch ~o se~ect. hs ~.c'~ca~ec~ beloh~, the ~xper~me..~2' . esults snow tha~ t~e ve~y smz' 1 pore s_-es do ~.ot ;llow good flbrous tissue ;~ DW~. wh.ls' ve-y '~ se ~o-~ sizes ter.~ tc p~od~_ce st_ue ~u. G charzc .e ~ s~_cs which ~~e mechan,cally not des~ ~2bi~ .
~he pl~.ctoJ~.'crc ~rz~lz seow.n -.. ~ig. ~ is a sect.on th-o~h c 2~0 r;. _~5~. po-e si7e c~ a~u~e ~.2de acco~ .s to che repi~mine~ c~ m 5. ccecs '. o~ ,'ysyloxane . T~a~. cross sec~l 3~. is ~ icz' o~ e~oss sec~_caC ~o ~e eY.~e_~ed irl the po~o~s c~l~r str ~c~ e ;2 cf em~c~mer,~s c' the ..nve~.t~o:-.
The replzr''~e~or~. p:ocess ~reco~ ar..ly ~lows co-.tro!
over po~e s~ ze an~ 2c:e size conc' s cer~.c-~ a-.d ;?ore ~n~ercor.r~ec~1vl~ . conj~_-.c:ion w'~. t~.is ~:ima~y 2~ cha zcte~ ~ s: c, co,. -~o, is a,co exerteo ove- ~.e "~?oros ~ t~ "
~de~ine~' zc the ~ra-tio~. o ~ e b~; vol~:n.e o~ the ~.2~e~ c occupie~ by voids ) c' the b~ocom~c~ ~ ~ e ma~e- ,a; ar.c', by 2~3333~
WO 90/l5636 PCr/AlJ90/002~2 ~l~o~ a ~;.,de choice c. b,o~om.p2~ e ...a~e-~ci clss ~:lows ~:C'`,~,C; QVe~ the c~rr~.;?;iG~:e c~ the ~r.cte- G .
he e.~.~s~i~e-.~ cc -~. ~h,e j?c cs t~r sho~
g~ea~e- :;~a-. 20~ ~r._, idec;l~, sho~ e ~r. ~he ~Z~s~ 2~ ~c ~sO, Wh.e-e ~he pr~ oaC s~-_ctur~ c. tl~e c~a'~ is ~.ade fro~, e~astome- c mzte~G:, ~he com~liance sno.~l ' be in the ra~g~
2; .o ~ S~o~e A po'nts az_ i~eally -. ti~ ge ~ to ~5 Sho~e ~ r~ rrc. ~h~ ~ t-~tc.~ 5~t ~ C ~ ber p-evio~-s ~ es ibec a~ ._s--a ~e~ -S . - hac 2 C~.. P_~G~e O' a~?ro~ r.G~e'~ s".o e ~ E~C ~.~s a.. - a po,~s O f arou~.ct. 30~, r ~ ~, . , c' srloses ~ secorld emb~ e~.~ c; ';~e ~ e..~ i or.
where };e p~s have ~ ~.e szme nu:~be~s ~s ~rl Fi~ Th~
str_c~ a;~ ts compos't~c~. s _~. c:` -espects t~.~ same as that desc. 1 bed wi ~h respGc~ ~o Fi~ . ', SGtre t~a . ~he c 's ~'aceo' pe~ .ar,eous,y so +h~ ~..cies e few .e-~es z.bov e the s~,.~'ace o' trle S\ i1~. 12y~5 ~ . The e~:pe~i~er.~r: -es._'~s ~o be desc._~e~ ~e_ow r.-icc~e ~hc.. ~hi5 p'zcemer.; o' ~ha cl; ' is r~ot as p~efe-re~ Z5 ~he 2~range...er.
o- ~ 5 .
Res.~l~s ~^ dzte ir.~'~cate t~z. t~e s~r~c~ure o' +he ~irs' embo~i~en~ describ~d w't~. re~rer~oe ~o Fis. . zllows use o~ the s~ple, ge~erc.l'y cyli~.d~icl cu C str_cture hzvir.~ isr.ztely th~ same di~e~.s ' or.s z.s the c ~- er.~ly pre.er~e_ Da--o~ e c... -fs use~ ~or zr.c~o-ing p~ poses.
~iowever the pa~ ticulzr struc~ure desor,be ~ here a' lows ~he possl~ y o~ placi~ the ~ eve~. ciose~ ~e tne s,~
WO 90/1 j636 Pcr/Al-lg~/~o~4~ 3 3 6 s` ~caCG ~2^~ ' 5 des_. ab' e w~ .e ~a~ . c:C ' s ~-~c ~_. ec t~e~ebv m2~ ., st:- ~cz~ i-.s~ o.. G2s~er ~ lesse~r.
--2'C.~ . ~ ~ ` O~`.Z ~ tne s ~~uc ~rs show= ~ron~i ~2 o .
~irovld'n~ 2-`. i.~proveG sec' a~2ins~ the o~s de enJ~-~r~.e~-c~ce _-.g-ow~h o~ ~o~y ce' ls int~ ~e porous ~ c~ e has tar~e~ C12Ce~ oveY a s ~ x wee'r~ or so pe-ic,~ .
SY.a.. ~`' e Su~ c .~ . ~r. e ~ c ' ~, r ~ 5 '; " ~ d _ s c c ~ e - c _ 1 8 ~ _ . . . a c~ove ~he s. ?e-~ic,a' fascic ~G S ~.UC.~' t~ mpo-t2nce o~ eo-~s~ _c~ e z~c. ro:e s~e? c-. ~.SS';E ~~cs~;~`a.
The ~r~ z' samr~le ct:'' s~~~c ~:-es we-e made ~'rc.
_one r_~be-, so~ a~.e an~ hycrcxyzpc~te usir.~ .3ae ~ es~!2~ .e'o~. p-ocess so ~s te p-o~_ce s2s!~.r~e s~r~_c~-es ;~av~:~5 res~ective'~ ~r ~._C~C.. ~ve-ase po~e C';7~, lC~ c o~, 2~e~2se pc~^ s_-e, 2C'' ~.~ c~o-. 2ve~c~ ?ore s-'-e a~ 50C
--. --ro.. ~ve~aSe po~e s ~e .
'rhe ^C .,. ~o-. ?or~ 5_2~ Ea~ es ~ eGC'~: C~
r_:e-- z;s showe- ' ~ ~ t e , ~ ~-o~_s : ~ S5~.16 _;`,'--Oh--~ i"...C
pc-es z~te- fo~_r weel;~ _~r.r~ ' or. . ~ . a~?ecred ~ho ~ the pore size wzs si~p'y too s~ o ~r- 6 ~fe--ive .
~ hc 100 ~r.ic-o~ s ~ c~u-es pe~f~rme~ well glvir~g ~a~ure c^;~ge-. arl~ 50O~ lng~owth 24te~ _o~r wee~s wlt~. the ~,a~c: ty c' ?ose ';'le~. ~ e '~.y~roY.yapa~~e ca-:se~ ~hr leas~
; .~,amm~tio:~ w~. 1st ~lyure-~ar~.~ c2use~ t:~Le ~.os:.
Th~ 200 ~ o. on sa~.~les pes~-med ;r.c,r ~. ~he sa~e zs ~;~r-loo ric-on ~ les b_~ w~ c,_a'~5~ c~ ow~. be_~~.~ c be ~t~ a-.~ t:~e ~r~.s~n ~ ...' lamJr,~-~ c-. be ~.5 - ~~ie 2~333~
W090/l~636 PCT/AU90tO~242 less. ~h~se s~,ples ,,, ~c~cet~ t~.e o~ u~. resul .5 .
O~.ly hy-~c~y2?2t~e sam~ies wer~ made wi~ CC ricro~.
~o-e Q~ze. ~e ,es_;~s Oc t~.~s s~~u~u~e wer~ ~e~e-~'`y t:~e same as ~or the ;OO zn~ ~OO ~.'e-on pore s'ze ~y~roxya~atite sarples. P.oweve-, hyc.. oxyap2-ite i5 b~Oac~i~e anG d.ssclves ~ the t~csles ove~ .ime. ~he 500 ~_c-on hy~o~y2pzl'~e s~p~e s~o~e~ a greater p-edelicticr ~o th~s benaviou- tha.
the s~,~lle ~^~e ~e h~,~c'~c~ya"atite s~,..rl~s.
. ~ener_ ~y ' l_~or. .ubbe- W2S four.~ to ~ave bet~e-- lO ir.~iar,r.e~ic-. beha~o~ hcn poly~-e~a2~e. ~y~-oxy2p2t' ~e ~-oba 1~ pe:~o-me~ t~.e bes~ ~s ~c- as ~~~lam~2~ior. ~es~lts are conee-nec ~u. is a~ .here~tly brittle materi21 w~c~
L~ CI~ hav~ the des~r~le co~ ee ehzrecte~-s~
s ~ lcone rub~er or ~oiy~-e-hz~e.
~xa~.~le 2 _s were a;co e-~ cte~ us~r.~ s.~ee,". ~.e c~eC~s ~se-~r.-luded an ~nteçr~' ~o~o~ ~'an.ce ~zd~ ~ro.~ the sa~.e t.~e res~ c' ~r.e poro~s s~,~c~ure c~ ~he C~ ' and eV.~e..- -.~ 2~r_ 0:;' ..-2 ~el~ .'l'imetres ~a~ al!y awzy ~.~r. ~~.e 2C _~' cy''.c-~ca' su-face. 5he ~ 6es we-e ~nco-pora~ed - ~ere'y 2s 2 ~u~s-~tu~e fo- the s~ 'is~ng effec: r.o~r,a ly ~-ov~e~ by the tube 1~ to ~lch the c~f 1~ is attac~.ed i-, n~ ' usa~. C~ s:~uc~ures c Dow Co r.~n~ Q~-48~0 s~l'cone r~be. an~ ~o'yurethan~, ~ot~. o~ lC0 ~.crcn ~ve.a_e pcre size ~n~ 200 ~icsor. ave:age pore size we-e ~ade acc~-c~r.g ~o ~he se?la_.ir.e'or~. p. ocess an_ ins .~' ie~ ~th ~ o~tæ~eous~y zn- p~r~u.æ~eo~zsly ~n ~hee~. Th.e CU5~
WO 90~1;636 PCr/AI,'~O/OO~ 3 ~ 3 3 S ~ tU~ es ~"e~e f !c-~g~r' ~s ~ . t~ e~' o~C z~ ' e~ hc ~eascns 5' ve~ h ~-e- ~ ol~s exz:r.?les . he "~ ess -' ~h~
i~rla~ ~C O~!er G ~welve wee-: z,.~ ~wer.;~ 5 ~:~ wee!; ~,e-ioc waC
obs e ~vec .
- U' ~imately ~he~ a2peare~ to be ~ ~ ~~ . c- 'fe~e~ce ir.
ep~er~c~ ~ehav_o.- be~wee:~ the ;OG ~icrc.. ~:~d the 202 r~c-or~.
pore s~ze ~ zn~s . T-s-owth t~ ssue wcs se~erai~y s ~ ' e ha~ing ~ib-o~'~ a~;s a;.~ ' o~ 1 eve:s c ' .,..~-.._c ,..~ am:rcr^r~
ce 1 s . Tiss~e vas. ~la~~ sa' ~ o~ was ar~var.~e~ w~ ~h~ e ;?~ es lC ~S~ rwe' ve weC.;c . ?e: - -_r..~ ~ .'lam,r~ Ar;' -es~onse W2~
w~ th ~o~e 'occl c~ ~ ;ec ~ o.:s C4 ly~hoc-~tes . Su}~c~ltaneous c~ ' placeme-.~ a::ower 'o~~m.a~_or. o. a r~c~ e sta~le '~ssue ~nterface a- rhe e~ ~ cite than per_~; ane~uc c~ placerr.en~ .
g~E~ .
. C~ C..-.~CG o r~ . 25 ~ene-~lly i` l:srrc-ted arld des~_ bed ~ espe~r c~ F_Ç. 1 O- F~ hæv~ns 2 ~
~,c-ous ~ .,ru-r- c5 i; ~u¢--a~ed _n sec~_c~ J n ~; 5 3 was pre~c -e~ o... Dow Sor~.'r., Q1-~,8~0 s~ ieo~.e ru~ber poro~s mate-..a: made us~ t:~e re?lar:~e~c-:: process. q'he ~ep'am,neforr, process w2s ca~rie~ c ~t SG 25 to p oduce 2 c'__C
3~avi~ o:slo~eneous . ir. Lercorn~cte~ pO~OU5 s ~ c~u-e ~vin 2 csmpli~nce of approx.m2te'Y ~ Shore A po~s, a ~oros_ty o' z~proi:imately 30% an~ - pore Size o" app. oxi~ately ~00 ~.icrome~e. s .
V2-ious ~4~;'icæ~...c-~.5 ~r.ay be ~ade i:l cetc'is oS esis.;
a~.~ co~.s~ruc~ i or. w:...'~o_~ de?a-t_r.s ~-o~. trle SC0~9 æn' 2r~
^~ t~.e i:~ve-. ~ ~ or. .
eac~. h~vin- pores an^ i~e-co~ne:;~ons betweer. tne po~es oÇ
essent~ t~e same c~er.sic... mhe re~l~m,nefo~^m process : uses the ric:o po~ous s~eleta~ s~-.~c~ure o~ seleoted ma~.r~e ~pecies as e ~em~late ~o ODt~ ' n ~e desire~ ~orous netwo ~ b~J
the p~ocess c_ ~ ng the void spaces in the s~eleta structu~e ~ith the ~esire~ biccorpat~_'e materizl an~ the~
etchi.~g away the s~eletzl structu-e itsel to leave only the b~ocomp~t'ble mate~ial. T~e process is charac~erised b5~ ~s abil;ty ~o p~oduce po~o~s struc~ures o~ the abo~e des_~ibed type. ~h~oughout th.s spe~ificatic~ t~.e use o' the ~erm "homo~e.~eouc, i~te~-~n~e~tec ~o-o~s s~.uc~u~e1~ h_~l be use~
to denote a pcrous s r~oture ~s Ges~~ibe~ b~ W~._te a~
2~3~33~
WO 90/1~636 PCI /~1~90~002~2 ~a~,2~ ~ cc b~ r"- r~ .ce- ~ e E~ ~ia~ .e~or~ ~. oc~s~ .
A ~".o~c..i~ ar:e c' c se~~ior. tho~ ch 2 '~00 n!.`C-C., po e s`7e 5~-UC-U~c ~o~ce- b~ ~he -C?~ar.~r.e~G ~r. p~ocess i~
re~ro~uce~ in ~ig . 3 o' th~ s svecif c I or. . ~he seade- of _5 spec~ _ca~c~ s eiSO .e e.rer to cther i' 'ussra~o~.s c' su-!~. porous s .r~c~u-es pro~uce by the :e~ r.e~o:- pO ocess a5, fot~ e~a~ ,le, _17us~-a~e-' r ~ pa~e ~75 o~ ~ om6~e-_~5, Yo ', ~, J~~ 1, h~he ~e ~ 2 ~ . ~c~ ~ 3 ~ ~ c ~ . c ~ ~--c ~,c ~he p~ecurs~. ..a;e-ia: ~9 showr ~ sec~.G:I ar.d -als~ ~c ~ ~ç.
0 G~ page :~ c' -~*mz~~ ~, " V~ ,ul~ 198~ e s .-..uc~_-es a~ e avzilabl e corr.me~ c_a' 1~ ~-or.. I:~te-pore 'r,7;erna.~0nc' r.e. ir. _~ inC, ~a'i orni~, Ur.-ted S;a;ee c.
Ame- ' ca .
Pre~e~ably, the rorous cu ' is :~a~e o~ me~ cal g~ade 15 s ~ ., i cor.e rubDe~ _s pos _ . ~ o ~.d e ~ the- subeu ,.ane~-:s 1~
(u:~der ~h6 s~ .) or ~e.~u~aneous'y (I.hrough tr.e s'.;ir.` t~ereby c;low~3 ~bro~ a-.~ eice-.~a' ~ssue i~Lrow:h ir.~o ~he pores r~e~ 5tir.s i-,~ia..: ar.'y:osic a..~ t_ssue slasil~~y ~eeded ~o preYer.~ ~r.fe_~ on o the s~ro_n~_~.s an~ u~er!yir.s tisseC
a-,d~c- avulsion zrd ex~e~ o-isa~'c. o~ the c~ r~, I~. a f~-the. preferre~ f~r~, the porous c1.~ is ~ad~
fro~ hyd-oxyapa.~te or t~?niu~ .
~ alte-n~ive pre.erre~ fo,m, the p5-OUS C__c is 3ace from ~ ocompat~'e ma.er.e~ com~.is'~. one D- more c' s_'icone rubbe-. se~ ri~ c'y~-e~.ar.e or o~h.~ so'~, elastome~_c ~.a~e~
The s~7e z-.d d~s~ga o~ l~.e c~C~ ~ - be ~e~ender.~ ~pO,.
WO 90/~636 PCI/A~O~O`~ 3 ~he si-e c~ ;h.c co~.dui ~ ~~Gns ,-essi-., tr~e skir.. .Io~eve~ e l~nç~ ' ran~e ucu~: y f-o~. or.e to sever~ times t:~e ei:ter~a' ~ 2me~er o' ~h~ co~ he t;.,ck~ess c~ ~he ~-,c, ~2~.~ b~ vzr~a~'~e dever.~ ~u upon po-e si~e and 2pplica~c-..
Pore s ,ze ic se ~ected such t;hat :t wili a' low in5sow r.
asl~ nur~~rin~, Of ~:` b~rcbizsts which lzy down colla$e?. fo~
'i~ro~s t~sue to ar.ky1ose the cor.du t ~hich the ?orcus mater~al sUsro~Ac.
Prefer2blv, ~he pore size o the cuCc (tha~ ic. tr.e averz~e ~ia~.e~er c the --egul2rly shape~ i..te~co~h~ ~ir.-; pore~ w~hin the c~ te-ia!) is ....... the ranse o' 3v t~ 5~0 u~ o~e pre'erc~'y the pcre size of ~he c~ff m~er~G! !ies ; ir. the rance ~5 tc ~00 ~ o~.etr~ ar.~ yet mo.e p-efe~ab's~ in the ranse 100 to 22~ ~ic~ometres. A. p~-~icu12~ pre~e-re~
fc-~ of the ~nve~ o~ has ~ po-e s~2e o' ~pproxi~ate,y 2 c-o~e ~,r~5, Tt ~ 5 21so ?refe rec ;hc~ the orosi~y o~' th.e CUCc (tha~ is. the f~a-~o. cc bul~ vo~ume o~ the ~ate~ial cc~u~ied bv vo~ds~ .s g~ea.e~ than ~C~. ~ore ~referab'~
~s desired tha~ ~.e pc-os'ty o~ the c~ff ma~erial l~es _r. the san~e ~$ to R'i%.
P~efe~a~' y where elasto~er~ mate-ia7s are used fo- the bio~o~pa~ble mate~ial ai~ comp'iance is in the range o' 2:
~o 8; o- ~.o~ pre~e~a~y ~ to ~O Sho~e A po~nts ~ased on s~2ncar~ ~ST~ ~es;s, Fio-e pre~era~ls~ _n the ran~e ~5 ,O ~e S~.ore A po_nts an~. ye' ~Dre p~e_erab'y, zippro~.~mate'y 4 Shore A points.
W090/t5636 PCT/AU90/o~ 323 3 6 e~_rs~ar.ceC ! ~.c :r~e.- co ~c~ves o~ ~c~ve s~
~ p~o~e t.re ~ ow~.. ~ . ss~ 2~ nh.~b~ th~
grow~h. c~ bac~e -_ ~.a, b~ cs~oc 2te~ e s~~~G~es c ir.te~s~ices cf ~h,~ po~es. ~ ssue ç;ow~h p.omoters w~ll ~.r:uce t~e che~.o.~ot_c ~ac~o~s suc~ cs p ateie~ de-'ve~
~row~h fa^~
The su:face o~ tr.e ro-es can be ~ .'ie~ tc ~m~rove t~ n~.ate ~_~z-~ t~,~ e~ , r! b~ e~ . a~
~.~c oP~ '; t~ S-- ~.ec~.~e~.~ w~:. ~olys yccl c 2ric.
~ab~le su~s~ar. es s c~. as gro~ h 'CctC.5 car. be p_ace~ h'~
~he ~o;res ~. 2 s~c_~ing ~eium s_ch as c coi'age~ oe~l.
Rob~st b~olos~Cc' 2:~1ve s~ec~es a~c ~bs~ces i~ te:~s o' the_~ ab l i ~y . o ~ ths;2r.~ subsecuent c;e~.~cc~ pu'ation . ~y be ~-zfted 'o o~ h'~'~.' r. th.e ~lyme~ faee by a v2~ie~y o~ che~.ical tec;~ es suc~. ~c ~iasmc ~r~'t_~g o~
incorporz~io.. ~ -h~ po yme: F~ o c~'f ~cr.uC2 - ~ e.
G.~f~r.c ~c~ e.c~~,~as~ covclen~ or ~o-e 'a~ile ~nter~olecula~
zt~rac~ions su_:~ zs t.~ose ir.vo!v~ .v~:osen bor.~ ns, ~ipole inte~ctions ar.- Var. de~ Waals 4Orces.
I~. a fu~r.e- ~oz~ fo~. Oc ~he _~ven~ion the~e is p~ovi~ed a method o~ ~o~ing a CU44 from bioco~p~ti~le ma~e-.~' for enclos r.~ ~ co~ for ~he pur~ose oÇ a~chor~s ~ai~ con~uit w ':~_n s'i~. laye-s an~ prC~Ctir.s a biOiosicâi sea'j S2~ me~hc_ cor.p~ ormi~ 2_~ b~oco~pztible ~ate-ia' ~r. s~oh a ~an~e~ thz~ ^ s st~ct~Ye i~ludes plurallty o~ po~es w~ h are h shly i~.tercon~e~te~.
WO 9~/1!;636 . PCrtA U90/002~2 2~333~
~ -e~e-~'y saic` ~,e;hc~ ~c_~cee us~ Or .~e repla~ e'or.~. p-oces5 ~c p-od~-e sc_~ b~ooompa~ie ~.z;e-_G'.
~ .~ ye~ fu~s;r~e~ b-oa~ fo-.-. o~ ~he ~ve.~~~c~ t~.~.e _ ~rovi~e~ ~ .issuC '~.te:~ce whe-eir~ a ~ssue se~l is 20~e~`
betwee:~ a CO~`lit anc' sl~r. i~.te-,ace, s~ tissue ~n~e-.ace co~.p-_s rg b_~com~zt_~'e ~a~e~ial ~ade ~y -he replar.inefc~~.
process whe~e~y ~ ~tr~ c~re .~a~ing con.-o;led porosity ~d z r~ornpliar;c~ ~n ~ ~rese~ecte~ -zn,e ~ t_ine~.
~ ~e~er~b'~ sa ~ poroci-y (.:.a~ i~, th~ fr2ct_0~ c^ '~
volu~.e~c~ t;~e rzse~_a' occupie~ by voids) ~s çre2le~ ~h2-. ~C~
ar.d r~ore ~re~erG~ly i~ e rar,ge 2'% .o 85~ eCe-ablv wr.ere elas-o~.e~c mzleria's ar~ used for ~"e ~ cco~.pz~ib'e m~e~s z`
sa~d cor,~l'zn~e i5 _n the rar.g_ o' ^: lo 6~ S~.o.e A ~oi~ts based on s.~n~zrd AS-~ tests, r.o-e p-e ~-c~ e ~cr.ge ~5 to 45 Shoro A ?oi~s an~, ~e~ ~ore ~.e~e~~ , a~pro~.imc.oly ~0 Sho~e ~. ~c~ s.
3 e R ~ 5 . . ~ Gh ~ c s '~; o~Ge- the~ .~.e i?.~ea-io~ ~a-~ oe mor~ reaci'~
unàe-s~ooc ard ps- .nto pr~:'ic21 e''e-:, re~e.ence w_l: no~
be ma~e ~_ ~he accompanying drawir.gs in which:-F 5 ' ~s 2 sc~e~a~'c view o' ~ pe~-utc~.e~ls zccess device acco~din~ to one embodimen~ o~ the inventio~ ~laced subcutaneo~sly, an~, Fi~ 2 is a view s~r.'l~ ~o Fi~re ; wi~h. the perc-~;z~eous access ~evice p~aced percu~aneo~s'v.
F~s ~ is a photomicrograph c' c ^~ m_c-cn po~e s'~e str~c~ure of Pn embodimen~ G~ the st-uc~ e zec- b~ e inve-.~ic...
~'0 90/l~636 PCr/AI.9~/00'42 2Q333~6 _ ~ s ~ c ~. c ' r. ? r e ~ 2 ---c r _ - - 5 r~
-~ 7. i S;'~0W~ G p~~C`.~;cneO~'` access ~evice co7r,~~~s_n c c~r.d~ 1 O o4 ar~rop-ia e cor~os- t~o:~ a~ e~ ;'^.. FG:
~e-~tone..; di21vs.6, 40r e..~mp' e, t~.e cathe ~e~ ~ s m~:~e 6, or s :~.or~e 5 1 ~-one ~ 25 ~r, o~ rsi_e d~amete~ etwee~
a~o.~ 7 .n~ llimetres ~ The cc~ passes th-ou5h an.
ir.cisio.. :; .r. th~ s~ c th~ b~y ~ssue 1~ Ir. the case o~ E)e. i ~or.ec;.L ci~lys s ~ ~ is der- i ~ed ~o ' ea~ hD oub~
O .~ ;a~e ~D- 2s io-~c ~s. poss~_1e_ f~ ~rr,~ OC~;s, ~r.cr.+~ or e~e.~ yea. s .
~ rO reme~ ~r. pla~e, the tube ~ C re~,u re~ ~G be ~eliG~'y 2~-h_-ec' wit~. r, ~he bo~ issue 1~ ~c~ ~his p~ ose z 'p'-_ _US C'_'4 ~ is 2~ .ache~' tc the pe. iphe-y o4 t.~e tube c;;
.Loc2~.~or~ mme_iately be_oh ~he s,.~ r. su~ ~ce. ~ no~-?orous sieeve 15 w~ic~ r.~eS-,a:l ~ connec; e~7 O t.~e ~si~e s~ ace 9~ ~he ~~o~s c~ s pe~-mzne.~'y co~.r.eete~ ~c .he o~e.-s_rC ce o t~ be :~ b; ~c ~he s~e? o' ~'_ ..~ c~.
be pe--or~e~ c~ ;he ~ ~e c' mæ~.~f2ct~re c' tube ;0 o~ i. c2e.
w pe-.ormeA d~ he o?e~ra+io~. ~o ~nse-~ the tl~e ~ ir.tG
the ~o~y t~ssue 1~" The no?.-po~us sleeve 15 se~ves to ~solate the pGrOUS s~r~_tu-e cc the cu~ ;2 '-o~ t~e slue Porous ma~e~~al from w~'ch the generally ~ylin~i-ica' CU5' ~ is ~,ade ~s ~,iocompc;~ble ma~eric! const,~e~e~ by the re~ia~lr.e'or~ ~r~cess so as .o ~cvi~e the blocompa;lble ma+~er'a' with ~ ho~oçe~eous ~.terco~-.eeted porous ~ruc~ure.
~he p.ocess itseiC ~s ~esc-ibe~ c~ examp'e, e-~ e ~?r~ c^~-o2-~ ?. z +_c;e bv Whi~e~ R.~ e~ ~:
. . ~ . .
W090/1~636 ~Cq~90/~02~2 2a3333~
en~le~ "Re~:a~. ne,o~r,: '. Ne~ ocese ~c~ P~epa~i~ Po.o-~s Ce~2.~ . Me~z:, ~nr ~cly.m~ . ~~OS ~he. - ~z~e._zls".
~ he ~ec~ e is use~ fo. du~'ic~~ir.s the microstr_^t-~re of carbcn2te s~eletc' com~or.er.~C ir. cerz~.ic, met~' or ~G'yme- ~a;e~ials. ~he ~ocess 2:10ws ccr.trol of pore size and the s~ze o' the l~te-connec ~ion between ad~acent pores. ~he process is p2-ticu' 2~ se'u' whe~e relat~vely ~lr.i~o~ p~re sl_e ~ pe--.ezb 1~ cc.~.e~
since c~-~o~ate skeletc st-_-.u es havir~ s~ac~.
cha~2cte-is-lcs z-e cc~.~.c~. ~ na~_-e.
Fo- pe-itonea' ~_clys~s, the heish~ (dl~.er.sio~ A ~n F_5. 1) of .he gene.~ y c;' nc~~cz' c_~c ~trl-c~ e is i~ the rzn~e Cf C.5 to 2 cer.time -es. Dimersion B i~ F's. : (the thic~ness o~ the ~oro~s s'~uct~re o' the c~') is i-. the ~znge O.S mi:''metre to ~ r,~l'imet~es. ~hese d~mens on6 vary accord~r.~ to the phyciczl size G' the patier.- or ar.i~l, the ~oy .oc~.ic~ o w~.^c~ e 'C ~s to be ~r~se~te~ ~n~
the pa-~_cula- tas~ which is ~o be per~o:me~ by the ~ube 10.
Fo- uses othe- thz~ pe~i~cnea' di~lysis, gener2~1y the ~imensior. P. wi' l be in the ra~gt 1 to S tin~es the outs~de di~meter o~ the tubla7 element e:~c 1 osed ~y the c~;f.
Di~ensior~s generally ~^e sele~te~' c~ d~ to the pz. r.cu;z-2p~ ic~tio:~.
~ :~ the su~cu.aneous a-~an~e~er.~ c Fi~ he c_ff 1~
is id~ally io~ated wi~h~ n ' centim.e ~, e o' t~.e sur.aco o~ the ski:, 11. i.e. the to~ of the cu^f '2 a~ ~l'us~rate~' is wi;h_r.
ce-.timete o' the su~^Cc~e CL Ihe s~ ~r. :.
2~3333~
~''" 90~1S636 PCI/AU90/~0242 ~`n6 i~.s~de diA~,ete- c.~ ti~e cu~ is selected to ~.c~c~.
the o~e~s'de d~ .r ~c- c~ I 'r.e tU~C '~'~.'s cl~r,er.s~c~
va--~ a-co~ ne t2s:~ w,._r;~ hc .'.~b~ C~ is ~c pe~ G.-r he po-e s,-e withl~. the porou~s s- ~c ~ure of the cu. ' S ' ~ ~ wn~ -o~.ceA GCCC~di r,g ,0 tr.e , e~ic~ e'orm process, ~ s rq~;tivel~J~ con~ nt, ucu~ . e se~r.c~ rio.C~ ur.
0~ of ~che ave-~5e p~re si~e c' the ~ ~r~:c ~ure .
Ave~G~e ;?o~e s ~ ze c~ e ~e'~ ec ' e~ e ~ .~r.ge ~C to ~OC Jr.ic~c~. . ~x~e-imer.t~' res.-' T.5 ~0 ea;e s-~g~est q5 10 ~o 3C~ ~.cror~.s c a p-~fer~ed -~o~^e si2s ranse C.orn ~;-~lch to select w;~ ~s~ :C0 ~o .~2C r~ c~or.s _s the rn,os ~ c~esired .2n~e from wr.lch ~o se~ect. hs ~.c'~ca~ec~ beloh~, the ~xper~me..~2' . esults snow tha~ t~e ve~y smz' 1 pore s_-es do ~.ot ;llow good flbrous tissue ;~ DW~. wh.ls' ve-y '~ se ~o-~ sizes ter.~ tc p~od~_ce st_ue ~u. G charzc .e ~ s~_cs which ~~e mechan,cally not des~ ~2bi~ .
~he pl~.ctoJ~.'crc ~rz~lz seow.n -.. ~ig. ~ is a sect.on th-o~h c 2~0 r;. _~5~. po-e si7e c~ a~u~e ~.2de acco~ .s to che repi~mine~ c~ m 5. ccecs '. o~ ,'ysyloxane . T~a~. cross sec~l 3~. is ~ icz' o~ e~oss sec~_caC ~o ~e eY.~e_~ed irl the po~o~s c~l~r str ~c~ e ;2 cf em~c~mer,~s c' the ..nve~.t~o:-.
The replzr''~e~or~. p:ocess ~reco~ ar..ly ~lows co-.tro!
over po~e s~ ze an~ 2c:e size conc' s cer~.c-~ a-.d ;?ore ~n~ercor.r~ec~1vl~ . conj~_-.c:ion w'~. t~.is ~:ima~y 2~ cha zcte~ ~ s: c, co,. -~o, is a,co exerteo ove- ~.e "~?oros ~ t~ "
~de~ine~' zc the ~ra-tio~. o ~ e b~; vol~:n.e o~ the ~.2~e~ c occupie~ by voids ) c' the b~ocom~c~ ~ ~ e ma~e- ,a; ar.c', by 2~3333~
WO 90/l5636 PCr/AlJ90/002~2 ~l~o~ a ~;.,de choice c. b,o~om.p2~ e ...a~e-~ci clss ~:lows ~:C'`,~,C; QVe~ the c~rr~.;?;iG~:e c~ the ~r.cte- G .
he e.~.~s~i~e-.~ cc -~. ~h,e j?c cs t~r sho~
g~ea~e- :;~a-. 20~ ~r._, idec;l~, sho~ e ~r. ~he ~Z~s~ 2~ ~c ~sO, Wh.e-e ~he pr~ oaC s~-_ctur~ c. tl~e c~a'~ is ~.ade fro~, e~astome- c mzte~G:, ~he com~liance sno.~l ' be in the ra~g~
2; .o ~ S~o~e A po'nts az_ i~eally -. ti~ ge ~ to ~5 Sho~e ~ r~ rrc. ~h~ ~ t-~tc.~ 5~t ~ C ~ ber p-evio~-s ~ es ibec a~ ._s--a ~e~ -S . - hac 2 C~.. P_~G~e O' a~?ro~ r.G~e'~ s".o e ~ E~C ~.~s a.. - a po,~s O f arou~.ct. 30~, r ~ ~, . , c' srloses ~ secorld emb~ e~.~ c; ';~e ~ e..~ i or.
where };e p~s have ~ ~.e szme nu:~be~s ~s ~rl Fi~ Th~
str_c~ a;~ ts compos't~c~. s _~. c:` -espects t~.~ same as that desc. 1 bed wi ~h respGc~ ~o Fi~ . ', SGtre t~a . ~he c 's ~'aceo' pe~ .ar,eous,y so +h~ ~..cies e few .e-~es z.bov e the s~,.~'ace o' trle S\ i1~. 12y~5 ~ . The e~:pe~i~er.~r: -es._'~s ~o be desc._~e~ ~e_ow r.-icc~e ~hc.. ~hi5 p'zcemer.; o' ~ha cl; ' is r~ot as p~efe-re~ Z5 ~he 2~range...er.
o- ~ 5 .
Res.~l~s ~^ dzte ir.~'~cate t~z. t~e s~r~c~ure o' +he ~irs' embo~i~en~ describ~d w't~. re~rer~oe ~o Fis. . zllows use o~ the s~ple, ge~erc.l'y cyli~.d~icl cu C str_cture hzvir.~ isr.ztely th~ same di~e~.s ' or.s z.s the c ~- er.~ly pre.er~e_ Da--o~ e c... -fs use~ ~or zr.c~o-ing p~ poses.
~iowever the pa~ ticulzr struc~ure desor,be ~ here a' lows ~he possl~ y o~ placi~ the ~ eve~. ciose~ ~e tne s,~
WO 90/1 j636 Pcr/Al-lg~/~o~4~ 3 3 6 s` ~caCG ~2^~ ' 5 des_. ab' e w~ .e ~a~ . c:C ' s ~-~c ~_. ec t~e~ebv m2~ ., st:- ~cz~ i-.s~ o.. G2s~er ~ lesse~r.
--2'C.~ . ~ ~ ` O~`.Z ~ tne s ~~uc ~rs show= ~ron~i ~2 o .
~irovld'n~ 2-`. i.~proveG sec' a~2ins~ the o~s de enJ~-~r~.e~-c~ce _-.g-ow~h o~ ~o~y ce' ls int~ ~e porous ~ c~ e has tar~e~ C12Ce~ oveY a s ~ x wee'r~ or so pe-ic,~ .
SY.a.. ~`' e Su~ c .~ . ~r. e ~ c ' ~, r ~ 5 '; " ~ d _ s c c ~ e - c _ 1 8 ~ _ . . . a c~ove ~he s. ?e-~ic,a' fascic ~G S ~.UC.~' t~ mpo-t2nce o~ eo-~s~ _c~ e z~c. ro:e s~e? c-. ~.SS';E ~~cs~;~`a.
The ~r~ z' samr~le ct:'' s~~~c ~:-es we-e made ~'rc.
_one r_~be-, so~ a~.e an~ hycrcxyzpc~te usir.~ .3ae ~ es~!2~ .e'o~. p-ocess so ~s te p-o~_ce s2s!~.r~e s~r~_c~-es ;~av~:~5 res~ective'~ ~r ~._C~C.. ~ve-ase po~e C';7~, lC~ c o~, 2~e~2se pc~^ s_-e, 2C'' ~.~ c~o-. 2ve~c~ ?ore s-'-e a~ 50C
--. --ro.. ~ve~aSe po~e s ~e .
'rhe ^C .,. ~o-. ?or~ 5_2~ Ea~ es ~ eGC'~: C~
r_:e-- z;s showe- ' ~ ~ t e , ~ ~-o~_s : ~ S5~.16 _;`,'--Oh--~ i"...C
pc-es z~te- fo~_r weel;~ _~r.r~ ' or. . ~ . a~?ecred ~ho ~ the pore size wzs si~p'y too s~ o ~r- 6 ~fe--ive .
~ hc 100 ~r.ic-o~ s ~ c~u-es pe~f~rme~ well glvir~g ~a~ure c^;~ge-. arl~ 50O~ lng~owth 24te~ _o~r wee~s wlt~. the ~,a~c: ty c' ?ose ';'le~. ~ e '~.y~roY.yapa~~e ca-:se~ ~hr leas~
; .~,amm~tio:~ w~. 1st ~lyure-~ar~.~ c2use~ t:~Le ~.os:.
Th~ 200 ~ o. on sa~.~les pes~-med ;r.c,r ~. ~he sa~e zs ~;~r-loo ric-on ~ les b_~ w~ c,_a'~5~ c~ ow~. be_~~.~ c be ~t~ a-.~ t:~e ~r~.s~n ~ ...' lamJr,~-~ c-. be ~.5 - ~~ie 2~333~
W090/l~636 PCT/AU90tO~242 less. ~h~se s~,ples ,,, ~c~cet~ t~.e o~ u~. resul .5 .
O~.ly hy-~c~y2?2t~e sam~ies wer~ made wi~ CC ricro~.
~o-e Q~ze. ~e ,es_;~s Oc t~.~s s~~u~u~e wer~ ~e~e-~'`y t:~e same as ~or the ;OO zn~ ~OO ~.'e-on pore s'ze ~y~roxya~atite sarples. P.oweve-, hyc.. oxyap2-ite i5 b~Oac~i~e anG d.ssclves ~ the t~csles ove~ .ime. ~he 500 ~_c-on hy~o~y2pzl'~e s~p~e s~o~e~ a greater p-edelicticr ~o th~s benaviou- tha.
the s~,~lle ~^~e ~e h~,~c'~c~ya"atite s~,..rl~s.
. ~ener_ ~y ' l_~or. .ubbe- W2S four.~ to ~ave bet~e-- lO ir.~iar,r.e~ic-. beha~o~ hcn poly~-e~a2~e. ~y~-oxy2p2t' ~e ~-oba 1~ pe:~o-me~ t~.e bes~ ~s ~c- as ~~~lam~2~ior. ~es~lts are conee-nec ~u. is a~ .here~tly brittle materi21 w~c~
L~ CI~ hav~ the des~r~le co~ ee ehzrecte~-s~
s ~ lcone rub~er or ~oiy~-e-hz~e.
~xa~.~le 2 _s were a;co e-~ cte~ us~r.~ s.~ee,". ~.e c~eC~s ~se-~r.-luded an ~nteçr~' ~o~o~ ~'an.ce ~zd~ ~ro.~ the sa~.e t.~e res~ c' ~r.e poro~s s~,~c~ure c~ ~he C~ ' and eV.~e..- -.~ 2~r_ 0:;' ..-2 ~el~ .'l'imetres ~a~ al!y awzy ~.~r. ~~.e 2C _~' cy''.c-~ca' su-face. 5he ~ 6es we-e ~nco-pora~ed - ~ere'y 2s 2 ~u~s-~tu~e fo- the s~ 'is~ng effec: r.o~r,a ly ~-ov~e~ by the tube 1~ to ~lch the c~f 1~ is attac~.ed i-, n~ ' usa~. C~ s:~uc~ures c Dow Co r.~n~ Q~-48~0 s~l'cone r~be. an~ ~o'yurethan~, ~ot~. o~ lC0 ~.crcn ~ve.a_e pcre size ~n~ 200 ~icsor. ave:age pore size we-e ~ade acc~-c~r.g ~o ~he se?la_.ir.e'or~. p. ocess an_ ins .~' ie~ ~th ~ o~tæ~eous~y zn- p~r~u.æ~eo~zsly ~n ~hee~. Th.e CU5~
WO 90~1;636 PCr/AI,'~O/OO~ 3 ~ 3 3 S ~ tU~ es ~"e~e f !c-~g~r' ~s ~ . t~ e~' o~C z~ ' e~ hc ~eascns 5' ve~ h ~-e- ~ ol~s exz:r.?les . he "~ ess -' ~h~
i~rla~ ~C O~!er G ~welve wee-: z,.~ ~wer.;~ 5 ~:~ wee!; ~,e-ioc waC
obs e ~vec .
- U' ~imately ~he~ a2peare~ to be ~ ~ ~~ . c- 'fe~e~ce ir.
ep~er~c~ ~ehav_o.- be~wee:~ the ;OG ~icrc.. ~:~d the 202 r~c-or~.
pore s~ze ~ zn~s . T-s-owth t~ ssue wcs se~erai~y s ~ ' e ha~ing ~ib-o~'~ a~;s a;.~ ' o~ 1 eve:s c ' .,..~-.._c ,..~ am:rcr^r~
ce 1 s . Tiss~e vas. ~la~~ sa' ~ o~ was ar~var.~e~ w~ ~h~ e ;?~ es lC ~S~ rwe' ve weC.;c . ?e: - -_r..~ ~ .'lam,r~ Ar;' -es~onse W2~
w~ th ~o~e 'occl c~ ~ ;ec ~ o.:s C4 ly~hoc-~tes . Su}~c~ltaneous c~ ' placeme-.~ a::ower 'o~~m.a~_or. o. a r~c~ e sta~le '~ssue ~nterface a- rhe e~ ~ cite than per_~; ane~uc c~ placerr.en~ .
g~E~ .
. C~ C..-.~CG o r~ . 25 ~ene-~lly i` l:srrc-ted arld des~_ bed ~ espe~r c~ F_Ç. 1 O- F~ hæv~ns 2 ~
~,c-ous ~ .,ru-r- c5 i; ~u¢--a~ed _n sec~_c~ J n ~; 5 3 was pre~c -e~ o... Dow Sor~.'r., Q1-~,8~0 s~ ieo~.e ru~ber poro~s mate-..a: made us~ t:~e re?lar:~e~c-:: process. q'he ~ep'am,neforr, process w2s ca~rie~ c ~t SG 25 to p oduce 2 c'__C
3~avi~ o:slo~eneous . ir. Lercorn~cte~ pO~OU5 s ~ c~u-e ~vin 2 csmpli~nce of approx.m2te'Y ~ Shore A po~s, a ~oros_ty o' z~proi:imately 30% an~ - pore Size o" app. oxi~ately ~00 ~.icrome~e. s .
V2-ious ~4~;'icæ~...c-~.5 ~r.ay be ~ade i:l cetc'is oS esis.;
a~.~ co~.s~ruc~ i or. w:...'~o_~ de?a-t_r.s ~-o~. trle SC0~9 æn' 2r~
^~ t~.e i:~ve-. ~ ~ or. .
Claims (35)
1. A percutaneous access device comprising a conduit adapted to be passed through the skin to define a portal to and from the body and a porous cuff of biocompatible material having pores formed into a porous structure therein place around the conduit; said biocompatible material having a homogeneous, interconnected structure of the type which can be produced by the replamineform process; said cuff adapted to be surgically placed so as to anchor said conduit within the body as a result of tissue ingrowth into said cuff.
2. The device of claim 1 wherein said cuff is generally cylindrical in shape and adapted to fit over and retain said conduit at a preselected location where said conduit passes through the skin.
3. The device of claim 2 wherein said cuff includes a non-porous internal sleeve.
4. The device of claim 1 or 2 or 3 wherein said porous cuff is made of medical grade silicone rubber, semi-rigid polyurethane or other soft, biocompatible elastomeric material.
5. The device of any one of claims 1 to 4 wherein said biocompatible material comprising said cuff has a compliance specified by a durometer reading in the range 21 to 81 Shore A or in the range 21 to 60 Shore A.
6. The device of claim 5 wherein said compliance is specified by a durometer reading in the range of 35 to 45.
7. The device of claim 6 wherein said durometer reading is approximately 40 Shore A.
8. The device of claim 1 or 2 or 3 wherein said porous cuff is made form hydroxyapatite or titanium.
9. The device of any one of claims 1 to 6 wherein said cuff is positioned subcutaneously.
10. The device of any one of claims 1 to 9 wherein said cuff is positioned percutaneously.
11. The device of any one of claims 1 to 10 wherein the interior of the pores in said porous cuff is impregnated with a substance which further promotes cellular growth and/or inhibits bacterial growth.
12. The device of any one of claims 1 to 11 wherein said pores have an average diameter in the range of 30 to 500 micrometers.
13. The device of any one of claims 1 to 12 wherein said cuff has a porosity of greater than 20%.
14. The device of any one of claims 1 to 13 wherein said cuff has a porosity of between 25% and 85%.
15. The device of any one of claims 1 to 14 wherein said biocompatible material is formed by use of the "replamineform process" wherein skeletal structures of marine invertebrates are used as template molds whereby a homogeneous, interconnected porous structure is obtained.
16. The device of any one of claims 1 to 15 wherein the size of the pores in said porous structure are selected to allow ingrowth and nurturing of fibroblasts which lay down collagen forming fibrous tissue to ankylose said conduit.
17. The device of any one of claims 1 to 16 wherein downgrowth of dermal and epidermal tissue is supported by said porous structure so as to form a seal which acts to prevent ingress of micro-organisms which would elicit a pathological state.
18. A method of forming a cuff from biocompatible material for enclosing a conduit for the purpose of anchoring said conduit within skin layers and promoting a biological seal;
said method comprising forming said biocompatible material in such a manner that its structure comprises a homogeneous, interconnected porous structure.
said method comprising forming said biocompatible material in such a manner that its structure comprises a homogeneous, interconnected porous structure.
19. The method of claim 16 wherein said biocompatible material has a porosity of greater than 20%.
20. The method of claim 19 wherein said material has a porosity in the range 25% to 85%.
21. The method of claim 18, 19 or 20 wherein said pores have an average diameter in the range of 30 to 500 micrometers.
22. The method of any one of claims 18 to 21 wherein said method includes use of the "replamineform" process to produce said biocompatible material.
23. A tissue interface material supportive of a surface wherein a tissue seal is formed between said surface and said tissue interface material so as to seal said surface within the body, said tissue interface material comprising biocompatible material having a homogeneous, interconnected structure whereby said tissue interface materialhas a structure having controlled porosity and a compliance in a preselected range.
24. The interface material of claim 23 wherein said surface extends percutaneously.
25. The interface material of claim 24 wherein said tissue seal acts to prevent ingress of micro-organisms which would elicit a pathological state.
26. The interface material of claim 23, 24 or 25 wherein said surface is the external surface of a conduit adapted to pass into the human body through a surgical incision.
27. The interface material of claim 23 or 24 or 25 or 26 wherein said porosity of said structure is greater than 20%.
28. The interface material of claim 23 or 27 wherein said compliance is in the range 21 to 60 Shore A points.
29. The tissue interface material of claim 28 wherein said compliance is in the range 35 to 45 Shore A points.
30. The tissue interface material of claim 29 wherein said compliance is approximately 40 Shore A points.
31. The tissue interface material of any one of claims 23 to 30 wherein said structure includes pores all selected to lie in the size range of 30 to 500 micrometers.
32. The tissue interface material of any one of claims 23 to 30, wherein said structure includes pores all selected to lie in the size range of 75 to 300 um.
33. The tissue interface material of any one of claims 23 to 30, wherein said structure includes pores all selected to lie in the size range of 100 to 220 um.
34. The tissue interface material of any one of claims 23 to 30, wherein said structure includes pores which are all approximately 200 um in size.
35. The tissue interface material of any one of claims 23 to 34 wherein said homogeneous, interconnected structure of said biocompatible material is produced by use of the replamineform process.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| AUPJ454789 | 1989-06-02 | ||
| AUPJ4547 | 1989-06-02 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2033336A1 true CA2033336A1 (en) | 1990-12-03 |
Family
ID=3773966
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA 2033336 Abandoned CA2033336A1 (en) | 1989-06-02 | 1990-06-01 | Porous percutaneous access device |
Country Status (3)
| Country | Link |
|---|---|
| EP (1) | EP0431102A4 (en) |
| CA (1) | CA2033336A1 (en) |
| WO (1) | WO1990015636A1 (en) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6636740B1 (en) | 1998-06-16 | 2003-10-21 | Ericsson Inc. | Apparatus and methods for position computation based on broadcast initialization data |
| WO2003082366A1 (en) * | 2002-03-28 | 2003-10-09 | Japan As Represented By President Of National Cardiovascular Center | Tissue engineering scaffold material, aritficial vessel, cuff member and coating for implants |
| WO2005084742A1 (en) * | 2004-03-08 | 2005-09-15 | Japan As Represented By President Of National Cardiovascular Center | Cuff member |
| FR3077207A1 (en) * | 2018-01-29 | 2019-08-02 | Franck Zinzindohoue-Marsaudon | CATHETER WITH CARBON-CARBON COMPOSITE SLEEVE |
Family Cites Families (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3699956A (en) * | 1970-10-01 | 1972-10-24 | Tecna Corp | Percutaneous lead device |
| DE2967214D1 (en) * | 1978-10-10 | 1984-10-18 | Ici Plc | Product adapted for transcutaneous use |
| US4278092A (en) * | 1979-07-05 | 1981-07-14 | American Hospital Supply Corporation | Peritoneal catheter |
| US4321914A (en) * | 1980-04-22 | 1982-03-30 | W. L. Gore & Associates, Inc. | Percutaneous conduit having PTFE skirt |
| DE3277521D1 (en) * | 1981-11-07 | 1987-12-03 | Laszlo Juhasz | Improved continuous ambulatory peritoneal dialysis system |
| SE452404B (en) * | 1984-02-03 | 1987-11-30 | Medinvent Sa | MULTILAYER PROTEST MATERIAL AND PROCEDURE FOR ITS MANUFACTURING |
| US4668222A (en) * | 1984-05-25 | 1987-05-26 | Thermedics Inc. | Percutaneous access device with removable tube |
| CA1245931A (en) * | 1984-09-21 | 1988-12-06 | Sophia Pesotchinsky | Positionable tissue interfacing device for the management of percutaneous conduits |
| SE452110B (en) * | 1984-11-08 | 1987-11-16 | Medinvent Sa | MULTILAYER PROTEST MATERIAL AND PROCEDURE FOR ITS MANUFACTURING |
| EP0269449A3 (en) * | 1986-11-26 | 1988-12-21 | BAXTER INTERNATIONAL INC. (a Delaware corporation) | Porous flexible radially expanded fluoropolymers and process for producing the same |
| JPS63183069A (en) * | 1987-01-27 | 1988-07-28 | 旭光学工業株式会社 | Implant material and its production |
| JPH0677602B2 (en) * | 1988-05-20 | 1994-10-05 | 旭光学工業株式会社 | Transdermal device |
| NL8802685A (en) * | 1988-11-02 | 1990-06-01 | Stichting Biomaterials Science | PERCUTANEOUS IMPLANT COMPRISING TWO COMPONENTS, AND A METHOD FOR IMPLANTING SUCH A PERCUTANEOUS IMPLANT IN SOFT TISSUES. |
-
1990
- 1990-06-01 WO PCT/AU1990/000242 patent/WO1990015636A1/en not_active Application Discontinuation
- 1990-06-01 CA CA 2033336 patent/CA2033336A1/en not_active Abandoned
- 1990-06-01 EP EP19900908419 patent/EP0431102A4/en not_active Withdrawn
Also Published As
| Publication number | Publication date |
|---|---|
| EP0431102A1 (en) | 1991-06-12 |
| EP0431102A4 (en) | 1992-01-08 |
| WO1990015636A1 (en) | 1990-12-27 |
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