CA1214702A - Medical apparatus for inducing scar tissue formation in a body - Google Patents
Medical apparatus for inducing scar tissue formation in a bodyInfo
- Publication number
- CA1214702A CA1214702A CA000434860A CA434860A CA1214702A CA 1214702 A CA1214702 A CA 1214702A CA 000434860 A CA000434860 A CA 000434860A CA 434860 A CA434860 A CA 434860A CA 1214702 A CA1214702 A CA 1214702A
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- balloon
- site
- thrombosis
- catheter
- iron
- Prior art date
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Abstract
TITLE: MEDICAL APPARATUS FOR INDUCING SCAR TISSUE
FORMATION IN A BODY
ABSTRACT
An inflatable balloon capable of being de-livered to a site within a body via a catheter or the like, includes on its surface a composition. The com-position is capable of inducing the formation of a thrombosis followed by invasion of capillaries and fibroblasts to the thrombosis and subsequent scar for mation. Scar formation fixedly adheres the balloon at its placement site to permanently locate the ballon at this placement site.
FORMATION IN A BODY
ABSTRACT
An inflatable balloon capable of being de-livered to a site within a body via a catheter or the like, includes on its surface a composition. The com-position is capable of inducing the formation of a thrombosis followed by invasion of capillaries and fibroblasts to the thrombosis and subsequent scar for mation. Scar formation fixedly adheres the balloon at its placement site to permanently locate the ballon at this placement site.
Description
~ " .N ~f~D
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BI~CKCROIJMD ().T~' ~r~ rNVl~;l`lrl':l OM
r~ i.'; i.llV(!Tl t:iO~I i.3 (l:i. ret~ e(:l l-.(`J ;IIl a~ a r-l tlls arl(l 1 proce3s in u-ti..l.i7.:intl thal ar)~ratu.s wll(~rehy a cornT~os:itlon i.s located on the surface of the apparatus such tha-t, upon in-tro-duction of the appa.ratus within a si.te in a hody, the composi-ti.on induces thrombosis fol:L.owed by capillary and fibrobl~st infiltra-tion and subsequent scar forrnation to E:ixedly hold the ap~aratus in position within the hocly.
In a paper ent:itled, "Ferromagnet:Lc Silicone Vascular Occlus:i.on In a Superconduc-ting Magnetic Field Preliminary Report"
Bulletin of the Los Anqeles Neurological Societies, Vol. 37, No. 2, ...... _ __ . .......... ..
April, 1972, 67, I, along with my co-author, described a technique of arterial occlusion with silicone emboli as a means for treating unresectable angiomatous neoplasms. In that paper, we described the use of iron microspheres as a means of attempting to hold a vulcanizing silicone mass in position within an artery. A super-conductin~ electromagnet was utilized to hold the iron spheres in i a fixed position within the artery after introduction of the iron spheres and the components of the vulcanizing mass via a catheter.
The iron spheres, in turn, were utilized to hold the vul.canizing mass in position until vulcanization was complete and a fixed hody was formed within the artery.
This techni~ue was extended to the treatment of cerebral aneurysms as was reported by me and the same co-author in "Treatment of Cerb~al.Aneurysms By Stereotaxic Fer~romagnetic '7~%
Sil.:lcone rrhrom~osis~ ulleti.n of. tllr__,o~, ~n(le!es ~Tellr_.-)gica.l.
.C;~cl.~ti.(.~.s~ _01 3a~ r~ r~ /3, ~ c~lnl(~
Eurttler extondecl to inFarction at a r~ort:ion of arl or~Jan as re-ported in my and rny co-author's paper entitled, "~erromagnetic Silicone Vascul~r Occlusion: A technique for Selective Inf~rction of Tumors and Organs", Anna1c, of Surqer~, VolO ]78, No. 5, ~ e~ r~ I ~ 663, __ As an ~mprovament over thQ techn.ique ut.i1izincJ the external magnet to po~i-t:ion the vulc~ni.~in~ a~ent having iron particles suspended therein, a technique was later developecl where-in a magnetic stereotaxic probe, which was shaped as a cylindrical magnet allowing :Eor insertion of a long, thin needle through the centerr was constructed. The magllet was of sufficient strength sueh that iron particles suspended in components capable of vul-canizing into an intact body, was introduced into an aneurysm or the like, by passing these components through the needle placed through the eenter of the maynet. The tip of the magnet was main-tained in contact ~ith the outside of the aneurysm or the like to maintain the position of the iron particles, and ~hus the vulcanized mass surrounding them, within the ane1lrysm .f.'or a period o.E time.
t: Upon introduction of a metallic thrombosis, the magnet was removed, leaving a vuleanized mass including the iron particles therein to fill up the aneurysm and thus lessen the chances of rupture of the same with an accompanying hemorrhage. This work is reported in "Stereotaxy of the Human srain", Edited b~ Schaltenbrand, G. and WalkerL A.E., et al, Theime-Stratton, Inc., New York, 1982, page . . _ . . _ . _ _ _ 6 _ ~47~2 The use o~ balloons to temporarily or peemanently occlucle a vessel or the ltke was originally pioneered by Serbinenko, JouLn~l Qf ~e~L-~s~e~
~1~125~ 7~. Along with several co-authors in, "Development of Detachable Vascular Balloon Catheter", Bulle~in oE th~ hQ~ ~n~el~ N~ULQlQ~ Qci~le~, VQ~L ~Ll ~Q~ 1. J~n~L 1~ , I de B cribe the inter~
cranial use of balloons ~or the occluslon oE a ves~el in an experimental animal~ Further, in the artlcle entitled, "Stereotaxy of the Human Brain" (op. cit.), further work with regard to these balloons is de-scribed. The deflated balloon is inserted utilizing a catheter in an appropriat0 vessel or artery. Once in position, the balloon is inflated and techniques are available for detaching the balloon from the catheter, allowing withdrawal of the catheter once the balloon is inflated and is in position.
As is noted in my article described above, entitledr "Stereotaxy of the Human ~rain", the presence o~ iron particles within the body results in the forma-tion of a metallic thrombus. As noted in that article, this thrombus can then serve to seal or eliminate an aneurysm from the circulation.
BRIEF DESCRIPTION OF THE INVENTION
In view of the above, it is a broad object of this invention to permanently affix a medical app-liance or the like within a body by utili~ing the metallic thrombosis reaction to cause interaction be-tween the body and the appliance, such that scar tis-sue will form around the appliance to fixedly hold the .t ' ~
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apr):Licance with:in ~he l)ody. I~ :is a furt~ ob-jec~: oE t~liS
:i.nvenl~ )rl to uti~ t-his m~ arl:ism t:o Fixe(l1~ ol(l medi.cal balloons in poCliti.on -in a l-ody. [t is ~n ~ (]it:ion~l ob-jc~(t to utilize t.he me-tallic throlrlbosis reaction to fixecl:Ly hold a mecl:ica]
balloon within a vessel, artery, fistula or aneurysm wi.-thin a bocly to seal said vessel, ar-tery, fistula or aneurysm.
These ancl other objects, as wi.ll hecc)me evi.dent from the remainder of this app:lication are ach:ieved in a ~roces~ oE
adhe:ring A medical apparatus wi.thin a human body which comprises:
incorporated onto the surface of saicl apparatus a composition having the property of inducing the formation of thrombosis followed by capillary and fibroblast invasion of the thrombosls and subsequent scar tissue formation; locating said apparatus in a position within said bocly for a period of time sufficient such that sai.d composition induces said formation of said thrombosis and said capillary and fibroblast invasion and subsequent scar tissue formation in an area within said ~ody adjacent to said position of sa:id apparatus.
These and other objects, as will also become evident from the remainder of this specification, are additionally achieved in a medical balloon which comprises: an inflatable balloon Eormed from an elastomeric material; a composition present on at least the surEace of sai.d balloon, said composition of the type capable of inducing the formation of thrombosis followed by invasion of capil-laries and fibroblasts and subsequent scar tissue formation.
The preferred composition for causing the thrombosis, capillary and fibroblast invasion and scar tissue formation would ~2~
be chosan from the grollp corlsist:i.ng o:C :i.roll, copper, t:~lnt~
qol.cl, sLlver an~'l plclt:inum. ~ mc)re r)re~eYrec'l grollr~ ron, co~per or tan-talillm. l~n even ~ore preEerred grour) wc)ulcll~e :in~oll and copper with lron Eorming the preferred composltion as present'l.y used.
The bal].oon woul.d be preferreclly Eormed of an elasto-mer:ic material such as a :I.a~e~, or silicone el.as~omer. rreferre(~
-the balloon woulcl be o:E the type capable of being inserted in the body by util.izat:ion of a catheter and detached ,from the catheter, inflated and left in the body upon withdrawal of the catheter.
BRIEF DESCRIPTION OF THE DRAWINGS
The invention descrihed in this specification will be better understood when taken in conjunction with the drawing wherein:
Figure 1 is an elevational view of a medical balloon as utilized in this invention;
Figure 2 is a sectional view about the lines 2-2 of Figure l;
Figure 3 is a hypothetical representational view show-ing use of a ba:lloon prepared and used as per this invention aslocated in an arterial aneurysm.
The invention described in this specification utilizes certain principles and/or concepts as are set forth and claimed in the claims appended hereto. Those skilled in the medical arts will realize that these principles and/or concepts are capable of being expressed in a variety of forms and/or embodiments. .~or this ~ - 5 -rO~-lSOrl, th:i.'3 inVCn~:iOIl i!l not to h(~ c~onc;t~rllc3~1 as be:in-l l.imite(l t:o th-` :L:I.]~ t:r.ltiv~ ml~ ner;~: (lescri.l)~ r(~in, I:)ut ;', I-o i--' con--strue(~ only ln lixlllt ol the c].a.i~s.
nL.T~II.ED DESCRIF'TION OF TEI~ INVEMTION
Certaln ano~alies of or to, or disease states of, vessels, arteries and organs assoclated therewith, are candidclte.s for .intra arteri.al-vess~-~l. surcJery. Includecl i.n thi.s group would be aneurysms, ar-t~rlal-venous mal.formation, :E.istulas, catastrophi.c trauma of, or neoplastic cliseases of organs. In all of these instances, potential rupture, as in aneurysms, or an actual openin~
in the cardiovascular network as in fisutlas, malformations and trauma, lend themselves to occlusion of the potential or actual opening in the cardiovascula.r network. Furtherl in catastrophic trauma to an organ, or in case of neoplastic infiltration of the organ, a total occlusion of the blood supply to the traumatized site, or to the neoplasmic site is also indicated.
In my prior work, boluses of vulcanized silicone have been introduced to the potential site of a rupture, or to the actual site of a rupture, by injection, via a catheter, needle or the like, of a vulcanizing mixture oE a vulcanizable silicone. In order to assist in maintaining the components at their intended site during the vulcanizing process, iron particles were suspended in the com-ponents of the vulcanizing mixture prior to injection at the site, and magnetism was utilized to maintain the mixture in position for a time suffieient to ensure completion of the vulcanization reaction, as well as thrombosis forma~ion as induced by the iron particles.
7~;2 13ecause the irc)n par~;.c:1.es were s11-3pendc~1 :i.n 1he compor1ents of the vu].-an:ix~.al-~le s:il:ic-)r1e, the t-ar-t:i.c1.et- ~/ere dis-persed throughout the ma-trix o-~ tlle final vulcanize(irna-terial.
Little or no control existed as to location of the particles on the external surEace of the final bo].us of the vulcanized material..
It is, of course, conceiva~l.e t~at a].l o:E the iron partieles coul~1 be incluclecl within -the inter:ior oF the Ei.nal vul.eaniz~d mas.s, wi-th none oE them projecting -through -the ex-ternal. s1c;.n o:E that vulcanized mass~ As sueh, the thrombosis reaetion produeed by these iron partieles would be absent, and upon removal of the magnetie foree holding the vuleanized mass in position at the site of vessel oeelusion, the potential existed for dislodgement from this site by the fluid forees present within the vessel or the like.
This problem is surmounted in this invention by in-eluding on the surfaee of a preformed medieal halloon or the like, suffieient eoneentration of a metallie thrombosis-producing material to insure that the metallic thrombosis reaction will occur and, upon formation of a thrombosis, capillary and fibroblast infiltra-tion, followed by sear tissue :Eormation, will insure permanent fixation of the balloon or the like at the oeelusion site. Sinee an external magnetie Eoree is not utilized to maintain the balloon or the like at the oeelusion site, it is only neeessary to inelude the metallic partieles in a very fine layer on the surfaee of the balloon or other oceludina apparatus, and .it is not neeessary to i.nclude the particles within the matrix of the material whieh con-stitute the supporting structure of the balloon or other oeeluding ~D~
...~
apparat~ls. While it wo~lld r,ot be con't:aindicatf!tl to so include the metclllic particle~ throughout the matrix of the supporting material, as is noted below, in the pre~erred method o~ formincJ the meclical balloon or other occluding apparatus, the metallic particles are located onl~ on the sur~ce of the occlud~rlg appc,ratlls.
The preferred occluding apparatus presently envisioned is formed as a detachable vas~!llar balloon insertable at the occlusion site by catheter insertion throu(~h an appropriate arterial venous structure. This allows for treatment of certain cerebral vascular anoma-lies, which are located in positions within the body not normally accessible through normal sursical tech-niques. Included would be such conditions a~ a caro-tid cavernous sinous fistula, cause~ by a severe head trauma or the like. Thus, to insert an appropriate occluding device, it would not be necessary to sub]ect the traumatized patient to intracranial surgery, because the appropriate occluding device could be located at the site of the fistula hy introduction through the carotid arter~, utilizing a flexible catheter introduced into the artery upstream from the trauma siteO
Certain metals are known to produce what can be described as a metallic thrombosis reaction~ Whenex-po~ed to the cardiovascular system, these metals pro-duce an initial thrombosis at the site of the metal.
The thrombosis is invaded by capillary formation and fi-~roblastæ andt ultimately~ a scar tiss~e mass orms at the slte. Known to prod~ce th~s reaction are iron, copper, tantall~mr and the noble ~etals, gold, silverr platinum, chr~mium and their deri~atives including oxides and alloys s~chs as stai~less steel. PrQsently preferred for use a the metallic thrombosis-producing material would be iron or copper. Tantalium ha-- an a(kle(l.~(lvant~ e Or al~;0 acti.n-l a(; a contraC~tin(l a~Jerlt for v;~;ual~ t-;oll of tl~e oc(ludincl ap!~ar;lt-uc;, using arter:iocJrams and the l:ike.
Normally, the metallic partic].es utilizable in the invention would be preEerredly oE a size of 5 microns or less.
It has been found that metallic particles of this 5ize or less are non-toxic to the body arlcl iE they are dislloc~ged Erom the surface oE the occlucling apparatus, they uJ.ti.mately, Eor the most part, find their wa~ throucJh the circulatory system to the spleen, where they are stored in a non~toxic state. While metallic parti-cles of a larger size could he utilized, because of the lack of toxicity of the 5 microns or less sized particles, it i5 preferred to utilize this size particles.
While other meta1.s might also produce the metallic thrombosis reaction, the toxicity of these particles in the body must be considered. ~11 of the metals noted above are considered to be non-toxic to the body, and as such, it is presently preferred to utilize metals chosen from this group.
As opposed to earlier proc:edures, wherein the metallic partiales utilized had to he magnetic because~ of the use of external magnetic sources ln holding the vulcani.zing material in place in the body, useful metals for this invention, wh.ile including magne-tically susceptible me~als such as iron, also include non-magnetic metals such as copper and the noble metals noted above.
Further, derivitive forms of preferred metals, where possible, can also be utilized. As - lo -auch, microspheres of carbonyl iron can be used as metallic thrombosis-prodllcing materlal. Other, similar derivative forms of known metallic thrombosis-producing materials could similarly be used, given proper con-sideration to their toxicity.
The presently preferred occluding apparatus wo~ld constitute a small balloon formed from an elastomeric material with the appropriate metallic thrombosis-producing material located on its surface.
Referring to the Figures, in Fig. 1l a balloon 10 is shown which, as seen in Fig. 2, is formed from a wall 12 surrouncling a hollow interior 14. The balloon 10 includes a stem 16 by which the balloon 10 is appropriately manipulated and attached to a catheter or insertion at the site of the occlusion. Located on the surface of the wall 12 is a coating of metallic particles 180 As shown in Fig. 1, l:he metallic coating 18 extends over most of the surface of the balloon 10 and as such, the metallic thrombosis reaction Eollowed by capillary and fibroblast infiltration and scar tis-~ue forma~ion~ would occur around the majority of the balloon 10 in a permanent manner at the site of the occlusion.
Preerredly, the balloon 10 is formed of a vulcanized silicone. Presently preferred to form the balloon would be a mixture of a silicone elastomer, and a dilutant therefor. All of these components should be approved :~L2~ 2 ~or use within the body~
While other elastomeric materials could be util-i~ed, consideration must be given as to toxicity and che like of these materials for use on a lvng term basis ~ith in the body. Other F.uch elastomeric materials co~ld L~e chosen based upon their toxicity for a long term utiliza-tlon. Matural latex wol~ld be includ~3 in a prePerrecl ~roup.
Once delivered to its occluding site within the ~ody, the metallic coated balloon 10 can be inflated via its positiuning catheter. The fluid inflating media utili~ed to inflate the balloon 10 could be an inert, inocuous material such as a prevulcaniæed mixkure of the Silastic 382 and Liquid 360 and an appropriate catalyst located th~r~in, or could be some other material, such as a radiopaque material which would assist in visuali zation of the in~place balloon.
Fig. 3 illustrates final placement of a balloon 10 within an aneurysm 20, which had formed ln the sur~ace of artery 22. ~he balloon 10 has been positioned within the aneurysm 20 and inflated. In Fig, 3, a time period has expired such that the metallic coating 18 on the surface of the balloon 10 has inter-acted with the body such that the metallic thrombosis reaction h~s occured, followed by in~iltration of capillaries and fibroblasts r with the subsequent for-mation o~ a scar tis~ue mass 24 having formed between the interioL walls of the aneurysm 20 and the surface of the ~alioon l0 such that th~ ball~on 10 is fixedly held within the 1nterior o~ the aneurvsm ~0. When 30 positioned within ~he aneurysm 20~ th~ ~alloon 10 and that portion 26 of the SC iY tis~ue ma~E; 24 located ~ith-ln the rlu:id channel w.it:hin t:he arl:ery 2,' Forms a -;ecll w-ith.in the :inl:c:r:i.or of t-he artery 2~ ~o permclnentl~ remove ~he alleurysrll ~n Erom the cl.rcu:l.ato:ry sy.qtem, removlng it a.s a po~-enticll si.te oE
catastroph.ic lea~.aqe from the ar-tery 22.
In a simllar manner, the ball.oons ln coulcl he located in appxopriate :Eistula.s whlch repre.sent: actual hemorrhaq:i.c .sites oE the arterial-venoucs system. ~'ur-thernlore, bal.loons 10 could he positloned direc~ly w:ithin an artery or vei.n to seal of:E all down~
stream portions of the ar-tery or vein as a therapeutic measure -to prevent hemorrhage downstre2m from the occlusion or seallng site, or as a therapeutic measure to deny a blood supply to a neoplasmic growth served by the artery being so occluded.
The ahlloon 10 of the invention is preformed outside of the body with the metallic coating 18 being introduced onto the surface of the balloon 10 prior to introduction into the body.
This alleviates or removes a consideration which had to be taken into account previously when vulcanization was done at the actual occlusion site. The vulcanization reaction, depending upon the amount of catalyst present and the like, is exothermia in nature.
In situ vulcanization, previously utilized, had to account for removal of the heat produced by the exothermic vulcanization reaction. It is evident that, at sites such as cerebral aneurysms and the like, production of heat at the site of the aneurysm culd be catastrophic if said heat produced during a vulcanization re-action resulted in degradation of the strength of the aneurysmal wall. It is, of course, quite evident that the status of a particular aneurysm could be such that bursting of the aneurysm ~ -- 12 -~4~0æ
an(l an accompany:Lnq hemc)rrlla~le could he l..lllrn:i ne~ n(l lle,-l 1: gf'rle r;l~e(1 :ln th~ rrollndi.n(J ~r~ c.l vlll.c-~rlizc~l-;oll r(!;l~t:ion (~ t~catas~rophlc catalyst resll:Ltinq in r~lptllre o~ the .,lme and its grave consequences. ~urthermore, the env:ironment of the aneurysm, such as within ~he brain, could be extremely sensi~ive to in si.tu procluction of heat. By pre-~orming the baJ.loon lO outside of the body, the .Einal elastomeri.c properties o:E the balloon 10 can be the clominant consideration, withou~ consi.c1eration having to be ~iven to any hea-t liberated during vulcani~ation which would occur by in situ formation of a balloon 10 or a correspondin~ mass of vulcanized silicone as previouslv practiced.
The balloon 10 is formed such that a small OpeninCJ 28 is formed in stem 16. Insofar as the balloon 10, including the stem 16, is formed of a elastomeric material, the stem 16 acts as a valve to seal oEf the openiny 28 unless an implement, such as a catheter or the like r iS actually physically located within the opening 28. For introduction into the hody, a first catheter would be inserted into the opening 28, with the stem 16 physically squeezing down against the outside of the catheter, maintaining the balloon 10 on to the catheter. When the balloon 10 was in its appropriate occlusion site within the body, it would be infla-ted by passing an appropriate inflating flu.icl via the catheter to the interior 14 of the balloon 10. Durlng inflation, the stem 16 would fixedly hold the balloon 10 on to the catheter positioned within the opening 23. After inflation is complete, a second catheter is passed coaxially over the first catheter. The second catheter is of a slightly larger diameter than the first catheter, allowing for slippinq of the second catheter along the total length of the f.irst ~clth~ter. When t~ second ca~heter completely encaC;es the first ccltheteL, it butts up against the end of the stem 16. Further movement of the second catheter along the first cath-eter pushes against the stem 16, squeezing the balloon 10 off oE the end o the irst cathet~r, dislodgin~
it from it~ A:Eter the balloon 10 i5 pushed o~ o~ the first catheter by the second catheter, the elastic force in the stem 16, by virtue oE its being formed of elastomeric material, squeezes the stem 16 down tight-ly, sealing the opening 28 to leakage of the fluid located within the interior 14.
The fluid utilized to fill the balloon 10 could be any one of a number o fluids, including a radiopa~ue fluid. Further, the fluid utilized to fill the balloon could be an unvulcanized mixture of the elastomer from which the balloon 10 was ~ormed.
~lowever, this mixture could be chosen such that the amount of catalyst would be small, and as such, the vulcanizing reaction would be slow, allowing for slow dispersion of the heat generated during vulcanization.
Insofar as the vulcani~ation reaction of the inflation fluid can be controlled, the vulcanization can be done in a manner to minimize heat liberation during poly-merization of the fluid utilized to inflate the balloon 10 .
Because of the nature of the materials util-ized to form the balloon 10, it is possible for the fluid utilized to inflate the balloon 10 to slowly per~
meate from within the interior 14 of the balloon 10, oau~ing deflating of ~he same. However, as opposed to prior use of balloons no~ having the metallic coating c1isc]o ed 1lare:Ln, iE Ihe t-i31loon shou:L(I cleFLal:f? al~ a lat1~r (I.1~e, suE~icie1ll time wou:l(1 have e~E)ir((l f()~ ~car ti.sue for1rlc~tiorl to occur, anc-1 even uE)on deEIat:Jon, there wou](l be no danger ol- 10~-3s o~ -the balloon lO from the slte because oE its lnclusion within an appropriate mass of scar tissue at the occlusion s:ite.
In fact, in the pas-t, the use of ba:Lloons not so coated as descr;bed in this invan-tion have become d:islodged from their site, and have resulted :in meclical comp:Lica-tions to the patients having received the same. By utilization of the metallic coating 18 on the balloon lO, retention of the balloon lO at its occlusion site is ensured, because of the formation of the scar tissue around the same.
Normally, the thrombosis reaction will occur soon after insertion of the balloon lO at the occlusion site. This will be followed by the capillary and fibroblast infiltration and formation of the scar tissue within a short period of time.
It can be considered that after two or three days time, sufficient scar tissue would have formed around the balloon lO to maintain the balloon lO permanently affixe.d at it:s occlusion site.
The size of the balloon lO utilized depends upon the siæa of the fistula, aneurysm or the like in which the balloon will be used. It :is normally considered that a minimum uninflated size of about l millimeter would represent the smallest size of balloon utilized, with the maximum size utilized depending upon the site of usage. Upon inflation, minimum balloon size would be about 2 millimeters, and maximum balloon size would extend up to~ but not necessarily re-X - 15 _ ~z~
- 1 () strictod ~l 10 mlllimetels. .~gaill, thc inFIatcd sizc of thc balloon clcpencls upon its sitc of US.IgC and sizc of the balloorl is not COTIS idcred critic.ll to this in-ven~ion~
The balloolls can ~)c formcd as eit}ler s~)hcres or clongatecl sausagc--like clcmcnts, a~aill deperl(ling upon thcir site Or usa~c~ l`ho wall t~lickllcss of thc balloon also would hc ~ictermined depenclin~ ul-orl tllc site of usage. ~ thiJIner w(:lll of course woukl hc util;zed for a smaller balloon an~ a smaller occlusion site with a thickcr walled balloon necessary for a l~rger balloon an(l a Iarger occlusion ;ite. Determina-tion of thc size and shape of the ballooll is, o~ course dependent upon -the s-ite oE usage of the sanle The b~lloons are fo-rmed as follows. A mix-ture of the components utilized to form the elastomeric material is made up and a mnn(lreL o~ all approl)riatc size is inserted in the mixture and coated. ~'re-ferredly~ the mandrel is then withdrawn from the mi~-ture and held horizontally in a chuck and slo~ly ro-tated, allowing for polymerization of the componerlts to form the elastomer surrounding the mandrel. A
balloon of a single coat can be made th;s way, or multiple coats can be built up by redippin~ the pre-vious ~formed balloon again into an elastomeric mix-turc and allowing slow vulcanization or polymeriz-tion to occur as the mandrel is slowly rotated in a horizontal position. Formation o~ the opening 2S in thc stem 16 would occur by having an appropriate waist section formed in the mandrel, allowing for a smaller diameter section to be formed at the stem 160 1~214~
After lllitiation of polymerization on the mandrel, and when polymerizaklon or vulcanlzation has occured to a su~fi-cient extent that the ~alloon can he peeled free Erom the mandrel, the polymer can then be heat treated to finalize the curing of the same. This would be done in a conventional manner, depending upon the exact elastomer utilized to form the balloon 10.
The amounts of the individual components of the final elastomer would be chosen such that the desired elastomeric pro-perties would be obtained. This is considered to be known to those art skilled in elastomers, and the exact mixtures would be chosen to correspond to known properties of the final elastomers.
Normally, for the preferred elastomer of this invention, a silicone elastomer, appropriate amounts of the ingredients noted above, would be mixed together with an appropriate amount of catalyst, allowing for a reasonable cure time as the mandrel was spun within a chuck. secause of the formation of the balloon outside of the body, as opposed to previous in situ vulcanization reactions, the amounts of the components utilized to form the balloon are subject to a wider variation, depending upon the final properties sought for the balloon 10.
The metallic coating 18 can be applied to the balloon 10 in one of several ways. If the balloon 10 is being made out of a single coat, or it is being made out of multiple coats, when the mandrel is removed from the component mixture, the mandrel is then "dusted" with the appropriate metallic material which will be utilized to form the metallic coating I8. The mandrel is ~ - 17 -~2~ 7V2 then insertecl in the chucl~ ancl the polyitlerlzation reaction is allowed to proceed, Wi~ll the "c~us-ted" coat of the coating material 1~ on the ou~side surface oE the final coat of the components from which the ba]loon 10 will be formed. Upon completion of the vulcanization or polymerization reaction with the metallic coating loeated thereon, the balloon 10 can then be heat treated to effect the final cure.
A second method of applyin~ the metallic coating would be to disperse the metallic coating in a separate mixture oE the elastomeric eomponents and, after build up of the initial wall 12 of the balloon 10, the final surface of the balloon 10 is obtained by dipping the mandrel into the component mixture having the metallic component suspended therein to form the final coat there-on, followed by rotation and heat treatment as before.
Upon polymerization or complete vuleanization of the components of the balloon 10, the metallic coating will be locked into the polymeric lattice so formed. Upon inflation of the balloon 10 at its occlusion site, expansion of the elastomeric material will separate the individual metallic particles. How-ever, they will still be present in a sufficient concentration toinduee the thrombosis and the subsequent sear tissue formation.
If any of the metallic particles forming the eoating 18 were sloughed off during inflation of the balloon 10, they of course would be deposited in the i~mediate area wherein the balloon 10 was being inflated and would still serve to initiate the metallic thrombosis response which would insure the subsequent scar tissue formation to permanently affix the balloon 10 at the chosen occlu-sion oæ
site .
.IL2~
BI~CKCROIJMD ().T~' ~r~ rNVl~;l`lrl':l OM
r~ i.'; i.llV(!Tl t:iO~I i.3 (l:i. ret~ e(:l l-.(`J ;IIl a~ a r-l tlls arl(l 1 proce3s in u-ti..l.i7.:intl thal ar)~ratu.s wll(~rehy a cornT~os:itlon i.s located on the surface of the apparatus such tha-t, upon in-tro-duction of the appa.ratus within a si.te in a hody, the composi-ti.on induces thrombosis fol:L.owed by capillary and fibrobl~st infiltra-tion and subsequent scar forrnation to E:ixedly hold the ap~aratus in position within the hocly.
In a paper ent:itled, "Ferromagnet:Lc Silicone Vascular Occlus:i.on In a Superconduc-ting Magnetic Field Preliminary Report"
Bulletin of the Los Anqeles Neurological Societies, Vol. 37, No. 2, ...... _ __ . .......... ..
April, 1972, 67, I, along with my co-author, described a technique of arterial occlusion with silicone emboli as a means for treating unresectable angiomatous neoplasms. In that paper, we described the use of iron microspheres as a means of attempting to hold a vulcanizing silicone mass in position within an artery. A super-conductin~ electromagnet was utilized to hold the iron spheres in i a fixed position within the artery after introduction of the iron spheres and the components of the vulcanizing mass via a catheter.
The iron spheres, in turn, were utilized to hold the vul.canizing mass in position until vulcanization was complete and a fixed hody was formed within the artery.
This techni~ue was extended to the treatment of cerebral aneurysms as was reported by me and the same co-author in "Treatment of Cerb~al.Aneurysms By Stereotaxic Fer~romagnetic '7~%
Sil.:lcone rrhrom~osis~ ulleti.n of. tllr__,o~, ~n(le!es ~Tellr_.-)gica.l.
.C;~cl.~ti.(.~.s~ _01 3a~ r~ r~ /3, ~ c~lnl(~
Eurttler extondecl to inFarction at a r~ort:ion of arl or~Jan as re-ported in my and rny co-author's paper entitled, "~erromagnetic Silicone Vascul~r Occlusion: A technique for Selective Inf~rction of Tumors and Organs", Anna1c, of Surqer~, VolO ]78, No. 5, ~ e~ r~ I ~ 663, __ As an ~mprovament over thQ techn.ique ut.i1izincJ the external magnet to po~i-t:ion the vulc~ni.~in~ a~ent having iron particles suspended therein, a technique was later developecl where-in a magnetic stereotaxic probe, which was shaped as a cylindrical magnet allowing :Eor insertion of a long, thin needle through the centerr was constructed. The magllet was of sufficient strength sueh that iron particles suspended in components capable of vul-canizing into an intact body, was introduced into an aneurysm or the like, by passing these components through the needle placed through the eenter of the maynet. The tip of the magnet was main-tained in contact ~ith the outside of the aneurysm or the like to maintain the position of the iron particles, and ~hus the vulcanized mass surrounding them, within the ane1lrysm .f.'or a period o.E time.
t: Upon introduction of a metallic thrombosis, the magnet was removed, leaving a vuleanized mass including the iron particles therein to fill up the aneurysm and thus lessen the chances of rupture of the same with an accompanying hemorrhage. This work is reported in "Stereotaxy of the Human srain", Edited b~ Schaltenbrand, G. and WalkerL A.E., et al, Theime-Stratton, Inc., New York, 1982, page . . _ . . _ . _ _ _ 6 _ ~47~2 The use o~ balloons to temporarily or peemanently occlucle a vessel or the ltke was originally pioneered by Serbinenko, JouLn~l Qf ~e~L-~s~e~
~1~125~ 7~. Along with several co-authors in, "Development of Detachable Vascular Balloon Catheter", Bulle~in oE th~ hQ~ ~n~el~ N~ULQlQ~ Qci~le~, VQ~L ~Ll ~Q~ 1. J~n~L 1~ , I de B cribe the inter~
cranial use of balloons ~or the occluslon oE a ves~el in an experimental animal~ Further, in the artlcle entitled, "Stereotaxy of the Human Brain" (op. cit.), further work with regard to these balloons is de-scribed. The deflated balloon is inserted utilizing a catheter in an appropriat0 vessel or artery. Once in position, the balloon is inflated and techniques are available for detaching the balloon from the catheter, allowing withdrawal of the catheter once the balloon is inflated and is in position.
As is noted in my article described above, entitledr "Stereotaxy of the Human ~rain", the presence o~ iron particles within the body results in the forma-tion of a metallic thrombus. As noted in that article, this thrombus can then serve to seal or eliminate an aneurysm from the circulation.
BRIEF DESCRIPTION OF THE INVENTION
In view of the above, it is a broad object of this invention to permanently affix a medical app-liance or the like within a body by utili~ing the metallic thrombosis reaction to cause interaction be-tween the body and the appliance, such that scar tis-sue will form around the appliance to fixedly hold the .t ' ~
70æ
apr):Licance with:in ~he l)ody. I~ :is a furt~ ob-jec~: oE t~liS
:i.nvenl~ )rl to uti~ t-his m~ arl:ism t:o Fixe(l1~ ol(l medi.cal balloons in poCliti.on -in a l-ody. [t is ~n ~ (]it:ion~l ob-jc~(t to utilize t.he me-tallic throlrlbosis reaction to fixecl:Ly hold a mecl:ica]
balloon within a vessel, artery, fistula or aneurysm wi.-thin a bocly to seal said vessel, ar-tery, fistula or aneurysm.
These ancl other objects, as wi.ll hecc)me evi.dent from the remainder of this app:lication are ach:ieved in a ~roces~ oE
adhe:ring A medical apparatus wi.thin a human body which comprises:
incorporated onto the surface of saicl apparatus a composition having the property of inducing the formation of thrombosis followed by capillary and fibroblast invasion of the thrombosls and subsequent scar tissue formation; locating said apparatus in a position within said bocly for a period of time sufficient such that sai.d composition induces said formation of said thrombosis and said capillary and fibroblast invasion and subsequent scar tissue formation in an area within said ~ody adjacent to said position of sa:id apparatus.
These and other objects, as will also become evident from the remainder of this specification, are additionally achieved in a medical balloon which comprises: an inflatable balloon Eormed from an elastomeric material; a composition present on at least the surEace of sai.d balloon, said composition of the type capable of inducing the formation of thrombosis followed by invasion of capil-laries and fibroblasts and subsequent scar tissue formation.
The preferred composition for causing the thrombosis, capillary and fibroblast invasion and scar tissue formation would ~2~
be chosan from the grollp corlsist:i.ng o:C :i.roll, copper, t:~lnt~
qol.cl, sLlver an~'l plclt:inum. ~ mc)re r)re~eYrec'l grollr~ ron, co~per or tan-talillm. l~n even ~ore preEerred grour) wc)ulcll~e :in~oll and copper with lron Eorming the preferred composltion as present'l.y used.
The bal].oon woul.d be preferreclly Eormed of an elasto-mer:ic material such as a :I.a~e~, or silicone el.as~omer. rreferre(~
-the balloon woulcl be o:E the type capable of being inserted in the body by util.izat:ion of a catheter and detached ,from the catheter, inflated and left in the body upon withdrawal of the catheter.
BRIEF DESCRIPTION OF THE DRAWINGS
The invention descrihed in this specification will be better understood when taken in conjunction with the drawing wherein:
Figure 1 is an elevational view of a medical balloon as utilized in this invention;
Figure 2 is a sectional view about the lines 2-2 of Figure l;
Figure 3 is a hypothetical representational view show-ing use of a ba:lloon prepared and used as per this invention aslocated in an arterial aneurysm.
The invention described in this specification utilizes certain principles and/or concepts as are set forth and claimed in the claims appended hereto. Those skilled in the medical arts will realize that these principles and/or concepts are capable of being expressed in a variety of forms and/or embodiments. .~or this ~ - 5 -rO~-lSOrl, th:i.'3 inVCn~:iOIl i!l not to h(~ c~onc;t~rllc3~1 as be:in-l l.imite(l t:o th-` :L:I.]~ t:r.ltiv~ ml~ ner;~: (lescri.l)~ r(~in, I:)ut ;', I-o i--' con--strue(~ only ln lixlllt ol the c].a.i~s.
nL.T~II.ED DESCRIF'TION OF TEI~ INVEMTION
Certaln ano~alies of or to, or disease states of, vessels, arteries and organs assoclated therewith, are candidclte.s for .intra arteri.al-vess~-~l. surcJery. Includecl i.n thi.s group would be aneurysms, ar-t~rlal-venous mal.formation, :E.istulas, catastrophi.c trauma of, or neoplastic cliseases of organs. In all of these instances, potential rupture, as in aneurysms, or an actual openin~
in the cardiovascular network as in fisutlas, malformations and trauma, lend themselves to occlusion of the potential or actual opening in the cardiovascula.r network. Furtherl in catastrophic trauma to an organ, or in case of neoplastic infiltration of the organ, a total occlusion of the blood supply to the traumatized site, or to the neoplasmic site is also indicated.
In my prior work, boluses of vulcanized silicone have been introduced to the potential site of a rupture, or to the actual site of a rupture, by injection, via a catheter, needle or the like, of a vulcanizing mixture oE a vulcanizable silicone. In order to assist in maintaining the components at their intended site during the vulcanizing process, iron particles were suspended in the com-ponents of the vulcanizing mixture prior to injection at the site, and magnetism was utilized to maintain the mixture in position for a time suffieient to ensure completion of the vulcanization reaction, as well as thrombosis forma~ion as induced by the iron particles.
7~;2 13ecause the irc)n par~;.c:1.es were s11-3pendc~1 :i.n 1he compor1ents of the vu].-an:ix~.al-~le s:il:ic-)r1e, the t-ar-t:i.c1.et- ~/ere dis-persed throughout the ma-trix o-~ tlle final vulcanize(irna-terial.
Little or no control existed as to location of the particles on the external surEace of the final bo].us of the vulcanized material..
It is, of course, conceiva~l.e t~at a].l o:E the iron partieles coul~1 be incluclecl within -the inter:ior oF the Ei.nal vul.eaniz~d mas.s, wi-th none oE them projecting -through -the ex-ternal. s1c;.n o:E that vulcanized mass~ As sueh, the thrombosis reaetion produeed by these iron partieles would be absent, and upon removal of the magnetie foree holding the vuleanized mass in position at the site of vessel oeelusion, the potential existed for dislodgement from this site by the fluid forees present within the vessel or the like.
This problem is surmounted in this invention by in-eluding on the surfaee of a preformed medieal halloon or the like, suffieient eoneentration of a metallie thrombosis-producing material to insure that the metallic thrombosis reaction will occur and, upon formation of a thrombosis, capillary and fibroblast infiltra-tion, followed by sear tissue :Eormation, will insure permanent fixation of the balloon or the like at the oeelusion site. Sinee an external magnetie Eoree is not utilized to maintain the balloon or the like at the oeelusion site, it is only neeessary to inelude the metallic partieles in a very fine layer on the surfaee of the balloon or other oceludina apparatus, and .it is not neeessary to i.nclude the particles within the matrix of the material whieh con-stitute the supporting structure of the balloon or other oeeluding ~D~
...~
apparat~ls. While it wo~lld r,ot be con't:aindicatf!tl to so include the metclllic particle~ throughout the matrix of the supporting material, as is noted below, in the pre~erred method o~ formincJ the meclical balloon or other occluding apparatus, the metallic particles are located onl~ on the sur~ce of the occlud~rlg appc,ratlls.
The preferred occluding apparatus presently envisioned is formed as a detachable vas~!llar balloon insertable at the occlusion site by catheter insertion throu(~h an appropriate arterial venous structure. This allows for treatment of certain cerebral vascular anoma-lies, which are located in positions within the body not normally accessible through normal sursical tech-niques. Included would be such conditions a~ a caro-tid cavernous sinous fistula, cause~ by a severe head trauma or the like. Thus, to insert an appropriate occluding device, it would not be necessary to sub]ect the traumatized patient to intracranial surgery, because the appropriate occluding device could be located at the site of the fistula hy introduction through the carotid arter~, utilizing a flexible catheter introduced into the artery upstream from the trauma siteO
Certain metals are known to produce what can be described as a metallic thrombosis reaction~ Whenex-po~ed to the cardiovascular system, these metals pro-duce an initial thrombosis at the site of the metal.
The thrombosis is invaded by capillary formation and fi-~roblastæ andt ultimately~ a scar tiss~e mass orms at the slte. Known to prod~ce th~s reaction are iron, copper, tantall~mr and the noble ~etals, gold, silverr platinum, chr~mium and their deri~atives including oxides and alloys s~chs as stai~less steel. PrQsently preferred for use a the metallic thrombosis-producing material would be iron or copper. Tantalium ha-- an a(kle(l.~(lvant~ e Or al~;0 acti.n-l a(; a contraC~tin(l a~Jerlt for v;~;ual~ t-;oll of tl~e oc(ludincl ap!~ar;lt-uc;, using arter:iocJrams and the l:ike.
Normally, the metallic partic].es utilizable in the invention would be preEerredly oE a size of 5 microns or less.
It has been found that metallic particles of this 5ize or less are non-toxic to the body arlcl iE they are dislloc~ged Erom the surface oE the occlucling apparatus, they uJ.ti.mately, Eor the most part, find their wa~ throucJh the circulatory system to the spleen, where they are stored in a non~toxic state. While metallic parti-cles of a larger size could he utilized, because of the lack of toxicity of the 5 microns or less sized particles, it i5 preferred to utilize this size particles.
While other meta1.s might also produce the metallic thrombosis reaction, the toxicity of these particles in the body must be considered. ~11 of the metals noted above are considered to be non-toxic to the body, and as such, it is presently preferred to utilize metals chosen from this group.
As opposed to earlier proc:edures, wherein the metallic partiales utilized had to he magnetic because~ of the use of external magnetic sources ln holding the vulcani.zing material in place in the body, useful metals for this invention, wh.ile including magne-tically susceptible me~als such as iron, also include non-magnetic metals such as copper and the noble metals noted above.
Further, derivitive forms of preferred metals, where possible, can also be utilized. As - lo -auch, microspheres of carbonyl iron can be used as metallic thrombosis-prodllcing materlal. Other, similar derivative forms of known metallic thrombosis-producing materials could similarly be used, given proper con-sideration to their toxicity.
The presently preferred occluding apparatus wo~ld constitute a small balloon formed from an elastomeric material with the appropriate metallic thrombosis-producing material located on its surface.
Referring to the Figures, in Fig. 1l a balloon 10 is shown which, as seen in Fig. 2, is formed from a wall 12 surrouncling a hollow interior 14. The balloon 10 includes a stem 16 by which the balloon 10 is appropriately manipulated and attached to a catheter or insertion at the site of the occlusion. Located on the surface of the wall 12 is a coating of metallic particles 180 As shown in Fig. 1, l:he metallic coating 18 extends over most of the surface of the balloon 10 and as such, the metallic thrombosis reaction Eollowed by capillary and fibroblast infiltration and scar tis-~ue forma~ion~ would occur around the majority of the balloon 10 in a permanent manner at the site of the occlusion.
Preerredly, the balloon 10 is formed of a vulcanized silicone. Presently preferred to form the balloon would be a mixture of a silicone elastomer, and a dilutant therefor. All of these components should be approved :~L2~ 2 ~or use within the body~
While other elastomeric materials could be util-i~ed, consideration must be given as to toxicity and che like of these materials for use on a lvng term basis ~ith in the body. Other F.uch elastomeric materials co~ld L~e chosen based upon their toxicity for a long term utiliza-tlon. Matural latex wol~ld be includ~3 in a prePerrecl ~roup.
Once delivered to its occluding site within the ~ody, the metallic coated balloon 10 can be inflated via its positiuning catheter. The fluid inflating media utili~ed to inflate the balloon 10 could be an inert, inocuous material such as a prevulcaniæed mixkure of the Silastic 382 and Liquid 360 and an appropriate catalyst located th~r~in, or could be some other material, such as a radiopaque material which would assist in visuali zation of the in~place balloon.
Fig. 3 illustrates final placement of a balloon 10 within an aneurysm 20, which had formed ln the sur~ace of artery 22. ~he balloon 10 has been positioned within the aneurysm 20 and inflated. In Fig, 3, a time period has expired such that the metallic coating 18 on the surface of the balloon 10 has inter-acted with the body such that the metallic thrombosis reaction h~s occured, followed by in~iltration of capillaries and fibroblasts r with the subsequent for-mation o~ a scar tis~ue mass 24 having formed between the interioL walls of the aneurysm 20 and the surface of the ~alioon l0 such that th~ ball~on 10 is fixedly held within the 1nterior o~ the aneurvsm ~0. When 30 positioned within ~he aneurysm 20~ th~ ~alloon 10 and that portion 26 of the SC iY tis~ue ma~E; 24 located ~ith-ln the rlu:id channel w.it:hin t:he arl:ery 2,' Forms a -;ecll w-ith.in the :inl:c:r:i.or of t-he artery 2~ ~o permclnentl~ remove ~he alleurysrll ~n Erom the cl.rcu:l.ato:ry sy.qtem, removlng it a.s a po~-enticll si.te oE
catastroph.ic lea~.aqe from the ar-tery 22.
In a simllar manner, the ball.oons ln coulcl he located in appxopriate :Eistula.s whlch repre.sent: actual hemorrhaq:i.c .sites oE the arterial-venoucs system. ~'ur-thernlore, bal.loons 10 could he positloned direc~ly w:ithin an artery or vei.n to seal of:E all down~
stream portions of the ar-tery or vein as a therapeutic measure -to prevent hemorrhage downstre2m from the occlusion or seallng site, or as a therapeutic measure to deny a blood supply to a neoplasmic growth served by the artery being so occluded.
The ahlloon 10 of the invention is preformed outside of the body with the metallic coating 18 being introduced onto the surface of the balloon 10 prior to introduction into the body.
This alleviates or removes a consideration which had to be taken into account previously when vulcanization was done at the actual occlusion site. The vulcanization reaction, depending upon the amount of catalyst present and the like, is exothermia in nature.
In situ vulcanization, previously utilized, had to account for removal of the heat produced by the exothermic vulcanization reaction. It is evident that, at sites such as cerebral aneurysms and the like, production of heat at the site of the aneurysm culd be catastrophic if said heat produced during a vulcanization re-action resulted in degradation of the strength of the aneurysmal wall. It is, of course, quite evident that the status of a particular aneurysm could be such that bursting of the aneurysm ~ -- 12 -~4~0æ
an(l an accompany:Lnq hemc)rrlla~le could he l..lllrn:i ne~ n(l lle,-l 1: gf'rle r;l~e(1 :ln th~ rrollndi.n(J ~r~ c.l vlll.c-~rlizc~l-;oll r(!;l~t:ion (~ t~catas~rophlc catalyst resll:Ltinq in r~lptllre o~ the .,lme and its grave consequences. ~urthermore, the env:ironment of the aneurysm, such as within ~he brain, could be extremely sensi~ive to in si.tu procluction of heat. By pre-~orming the baJ.loon lO outside of the body, the .Einal elastomeri.c properties o:E the balloon 10 can be the clominant consideration, withou~ consi.c1eration having to be ~iven to any hea-t liberated during vulcani~ation which would occur by in situ formation of a balloon 10 or a correspondin~ mass of vulcanized silicone as previouslv practiced.
The balloon 10 is formed such that a small OpeninCJ 28 is formed in stem 16. Insofar as the balloon 10, including the stem 16, is formed of a elastomeric material, the stem 16 acts as a valve to seal oEf the openiny 28 unless an implement, such as a catheter or the like r iS actually physically located within the opening 28. For introduction into the hody, a first catheter would be inserted into the opening 28, with the stem 16 physically squeezing down against the outside of the catheter, maintaining the balloon 10 on to the catheter. When the balloon 10 was in its appropriate occlusion site within the body, it would be infla-ted by passing an appropriate inflating flu.icl via the catheter to the interior 14 of the balloon 10. Durlng inflation, the stem 16 would fixedly hold the balloon 10 on to the catheter positioned within the opening 23. After inflation is complete, a second catheter is passed coaxially over the first catheter. The second catheter is of a slightly larger diameter than the first catheter, allowing for slippinq of the second catheter along the total length of the f.irst ~clth~ter. When t~ second ca~heter completely encaC;es the first ccltheteL, it butts up against the end of the stem 16. Further movement of the second catheter along the first cath-eter pushes against the stem 16, squeezing the balloon 10 off oE the end o the irst cathet~r, dislodgin~
it from it~ A:Eter the balloon 10 i5 pushed o~ o~ the first catheter by the second catheter, the elastic force in the stem 16, by virtue oE its being formed of elastomeric material, squeezes the stem 16 down tight-ly, sealing the opening 28 to leakage of the fluid located within the interior 14.
The fluid utilized to fill the balloon 10 could be any one of a number o fluids, including a radiopa~ue fluid. Further, the fluid utilized to fill the balloon could be an unvulcanized mixture of the elastomer from which the balloon 10 was ~ormed.
~lowever, this mixture could be chosen such that the amount of catalyst would be small, and as such, the vulcanizing reaction would be slow, allowing for slow dispersion of the heat generated during vulcanization.
Insofar as the vulcani~ation reaction of the inflation fluid can be controlled, the vulcanization can be done in a manner to minimize heat liberation during poly-merization of the fluid utilized to inflate the balloon 10 .
Because of the nature of the materials util-ized to form the balloon 10, it is possible for the fluid utilized to inflate the balloon 10 to slowly per~
meate from within the interior 14 of the balloon 10, oau~ing deflating of ~he same. However, as opposed to prior use of balloons no~ having the metallic coating c1isc]o ed 1lare:Ln, iE Ihe t-i31loon shou:L(I cleFLal:f? al~ a lat1~r (I.1~e, suE~icie1ll time wou:l(1 have e~E)ir((l f()~ ~car ti.sue for1rlc~tiorl to occur, anc-1 even uE)on deEIat:Jon, there wou](l be no danger ol- 10~-3s o~ -the balloon lO from the slte because oE its lnclusion within an appropriate mass of scar tissue at the occlusion s:ite.
In fact, in the pas-t, the use of ba:Lloons not so coated as descr;bed in this invan-tion have become d:islodged from their site, and have resulted :in meclical comp:Lica-tions to the patients having received the same. By utilization of the metallic coating 18 on the balloon lO, retention of the balloon lO at its occlusion site is ensured, because of the formation of the scar tissue around the same.
Normally, the thrombosis reaction will occur soon after insertion of the balloon lO at the occlusion site. This will be followed by the capillary and fibroblast infiltration and formation of the scar tissue within a short period of time.
It can be considered that after two or three days time, sufficient scar tissue would have formed around the balloon lO to maintain the balloon lO permanently affixe.d at it:s occlusion site.
The size of the balloon lO utilized depends upon the siæa of the fistula, aneurysm or the like in which the balloon will be used. It :is normally considered that a minimum uninflated size of about l millimeter would represent the smallest size of balloon utilized, with the maximum size utilized depending upon the site of usage. Upon inflation, minimum balloon size would be about 2 millimeters, and maximum balloon size would extend up to~ but not necessarily re-X - 15 _ ~z~
- 1 () strictod ~l 10 mlllimetels. .~gaill, thc inFIatcd sizc of thc balloon clcpencls upon its sitc of US.IgC and sizc of the balloorl is not COTIS idcred critic.ll to this in-ven~ion~
The balloolls can ~)c formcd as eit}ler s~)hcres or clongatecl sausagc--like clcmcnts, a~aill deperl(ling upon thcir site Or usa~c~ l`ho wall t~lickllcss of thc balloon also would hc ~ictermined depenclin~ ul-orl tllc site of usage. ~ thiJIner w(:lll of course woukl hc util;zed for a smaller balloon an~ a smaller occlusion site with a thickcr walled balloon necessary for a l~rger balloon an(l a Iarger occlusion ;ite. Determina-tion of thc size and shape of the ballooll is, o~ course dependent upon -the s-ite oE usage of the sanle The b~lloons are fo-rmed as follows. A mix-ture of the components utilized to form the elastomeric material is made up and a mnn(lreL o~ all approl)riatc size is inserted in the mixture and coated. ~'re-ferredly~ the mandrel is then withdrawn from the mi~-ture and held horizontally in a chuck and slo~ly ro-tated, allowing for polymerization of the componerlts to form the elastomer surrounding the mandrel. A
balloon of a single coat can be made th;s way, or multiple coats can be built up by redippin~ the pre-vious ~formed balloon again into an elastomeric mix-turc and allowing slow vulcanization or polymeriz-tion to occur as the mandrel is slowly rotated in a horizontal position. Formation o~ the opening 2S in thc stem 16 would occur by having an appropriate waist section formed in the mandrel, allowing for a smaller diameter section to be formed at the stem 160 1~214~
After lllitiation of polymerization on the mandrel, and when polymerizaklon or vulcanlzation has occured to a su~fi-cient extent that the ~alloon can he peeled free Erom the mandrel, the polymer can then be heat treated to finalize the curing of the same. This would be done in a conventional manner, depending upon the exact elastomer utilized to form the balloon 10.
The amounts of the individual components of the final elastomer would be chosen such that the desired elastomeric pro-perties would be obtained. This is considered to be known to those art skilled in elastomers, and the exact mixtures would be chosen to correspond to known properties of the final elastomers.
Normally, for the preferred elastomer of this invention, a silicone elastomer, appropriate amounts of the ingredients noted above, would be mixed together with an appropriate amount of catalyst, allowing for a reasonable cure time as the mandrel was spun within a chuck. secause of the formation of the balloon outside of the body, as opposed to previous in situ vulcanization reactions, the amounts of the components utilized to form the balloon are subject to a wider variation, depending upon the final properties sought for the balloon 10.
The metallic coating 18 can be applied to the balloon 10 in one of several ways. If the balloon 10 is being made out of a single coat, or it is being made out of multiple coats, when the mandrel is removed from the component mixture, the mandrel is then "dusted" with the appropriate metallic material which will be utilized to form the metallic coating I8. The mandrel is ~ - 17 -~2~ 7V2 then insertecl in the chucl~ ancl the polyitlerlzation reaction is allowed to proceed, Wi~ll the "c~us-ted" coat of the coating material 1~ on the ou~side surface oE the final coat of the components from which the ba]loon 10 will be formed. Upon completion of the vulcanization or polymerization reaction with the metallic coating loeated thereon, the balloon 10 can then be heat treated to effect the final cure.
A second method of applyin~ the metallic coating would be to disperse the metallic coating in a separate mixture oE the elastomeric eomponents and, after build up of the initial wall 12 of the balloon 10, the final surface of the balloon 10 is obtained by dipping the mandrel into the component mixture having the metallic component suspended therein to form the final coat there-on, followed by rotation and heat treatment as before.
Upon polymerization or complete vuleanization of the components of the balloon 10, the metallic coating will be locked into the polymeric lattice so formed. Upon inflation of the balloon 10 at its occlusion site, expansion of the elastomeric material will separate the individual metallic particles. How-ever, they will still be present in a sufficient concentration toinduee the thrombosis and the subsequent sear tissue formation.
If any of the metallic particles forming the eoating 18 were sloughed off during inflation of the balloon 10, they of course would be deposited in the i~mediate area wherein the balloon 10 was being inflated and would still serve to initiate the metallic thrombosis response which would insure the subsequent scar tissue formation to permanently affix the balloon 10 at the chosen occlu-sion oæ
site .
Claims (8)
PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. A medical balloon which comprises:
an inflatable balloon formed from an elastomeric material;
a composition present on at last the surface of said balloon, said composition of a type capable of inducing the formation of thrombosis followed by invasion of capillaries and fibroblasts and subsequent scar tissue formation.
an inflatable balloon formed from an elastomeric material;
a composition present on at last the surface of said balloon, said composition of a type capable of inducing the formation of thrombosis followed by invasion of capillaries and fibroblasts and subsequent scar tissue formation.
2. The balloon of claim 1 wherein:
said composition is chosen from the group consisting of iron, copper, tantanium, gold, silver, platinum and their derivatives.
said composition is chosen from the group consisting of iron, copper, tantanium, gold, silver, platinum and their derivatives.
3. The balloon of claim 2 wherein:
said elastomeric material is a silicone elastomer or latex.
said elastomeric material is a silicone elastomer or latex.
4. The balloon of claim 3 wherein:
said composition is chosen from the group consisting of iron, copper, tantalium and their derivatives.
said composition is chosen from the group consisting of iron, copper, tantalium and their derivatives.
5. The balloon of claim 4 wherein:
said composition is iron.
said composition is iron.
6. The balloon of claim 5 wherein:
said composition is carbonyl iron.
said composition is carbonyl iron.
7. The balloon of claim 6 wherein:
said carbonyl iron is present in a particle size of 5 microns or smaller.
said carbonyl iron is present in a particle size of 5 microns or smaller.
8. The balloon of claim 3 wherein:
said material comprises a vulcanized silicone.
said material comprises a vulcanized silicone.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US42908882A | 1982-09-30 | 1982-09-30 | |
| US429,088 | 1982-09-30 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1214702A true CA1214702A (en) | 1986-12-02 |
Family
ID=23701744
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA000434860A Expired CA1214702A (en) | 1982-09-30 | 1983-08-18 | Medical apparatus for inducing scar tissue formation in a body |
Country Status (1)
| Country | Link |
|---|---|
| CA (1) | CA1214702A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR2608418A1 (en) * | 1986-12-18 | 1988-06-24 | Pieronne Alain | Device allowing obstruction of a natural channel such as an artery, in particular in a predetermined zone |
| DE4324994C1 (en) * | 1993-07-26 | 1995-02-23 | Demetron Gmbh | Equipment and sanitary articles for hospitals |
-
1983
- 1983-08-18 CA CA000434860A patent/CA1214702A/en not_active Expired
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR2608418A1 (en) * | 1986-12-18 | 1988-06-24 | Pieronne Alain | Device allowing obstruction of a natural channel such as an artery, in particular in a predetermined zone |
| DE4324994C1 (en) * | 1993-07-26 | 1995-02-23 | Demetron Gmbh | Equipment and sanitary articles for hospitals |
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| Date | Code | Title | Description |
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| MKEX | Expiry |