CA2222149A1 - Flexible source wire for localized internal irradiation of tissue - Google Patents
Flexible source wire for localized internal irradiation of tissue Download PDFInfo
- Publication number
- CA2222149A1 CA2222149A1 CA002222149A CA2222149A CA2222149A1 CA 2222149 A1 CA2222149 A1 CA 2222149A1 CA 002222149 A CA002222149 A CA 002222149A CA 2222149 A CA2222149 A CA 2222149A CA 2222149 A1 CA2222149 A1 CA 2222149A1
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- CA
- Canada
- Prior art keywords
- wire
- tube
- backbone
- housing tube
- radioactive
- 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
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Classifications
-
- G—PHYSICS
- G21—NUCLEAR PHYSICS; NUCLEAR ENGINEERING
- G21F—PROTECTION AGAINST X-RADIATION, GAMMA RADIATION, CORPUSCULAR RADIATION OR PARTICLE BOMBARDMENT; TREATING RADIOACTIVELY CONTAMINATED MATERIAL; DECONTAMINATION ARRANGEMENTS THEREFOR
- G21F5/00—Transportable or portable shielded containers
- G21F5/015—Transportable or portable shielded containers for storing radioactive sources, e.g. source carriers for irradiation units; Radioisotope containers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N5/00—Radiation therapy
- A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
- A61N5/1001—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
- A61N5/1002—Intraluminal radiation therapy
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N5/00—Radiation therapy
- A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
- A61N5/1001—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
- A61N2005/1019—Sources therefor
- A61N2005/1025—Wires
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49826—Assembling or joining
- Y10T29/49888—Subsequently coating
Abstract
A flexible source wire (10) is provided containing a radioactive source (160) that is capable of maneuvering through a tortuous narrow passage to a treatment site within the body. This source wire (10) includes a thin flexible housing tube (120), housing therein a flexible backbone wire (130), wherein both the tube (120) and the wire (10) are constructed from a material exhibiting little or no memory retention when bent. A radioactive core (160) is provided in the proximal end of the flexible housing tube (120) and abuts the proximal end of the backbone wire (130). Both ends of the source wire (10) are sealed and the proximal end of the source wire (10) is rounded to allow ease of movement as it travels through the bends and turns in the body.
Description
W O 96/40352 PCTrJ~C/0~6gB
FLEXIBI,E SOURCE WIRE FOR LOC,~.r7.F.n INTERNAL ~RRADI~TION OF TISSUE
RFFFRF~CF T~ RFT ATF~ T~Al~FNT APPrTCAl~ONS
The present application is a c o. ~ l ;on-in-part of U.S . application Seriai No. 08/257,045 filcd June 8, 1994 and entitied "Flexible Source Wire for Radiation T~ t of Diseases," the entire coments and ~licclosllre of wi~ich are hereby specifically il~co~oldL_d by ~c~c~cc.
FTT-T.n OF lH~ irrVF~O~
The present invention relates generaily to rarlio~rrive source wires used to i~lddidle body tissue in the h~ e-~L of disease. More particulariy, the present invention relates to the use of an clon~r~d r~;ioartive source w~re with ~Ledsed fiexibility for the loc~li7~d delivery of r;3~i~tion to di~e~eA tissue.
1~
W O 9-~40~2 PCT~US~G,'~8B
RACKGROUI~D OF T~F lNV~NTrON
Radiation is used to treat cancer and other f~i~e~seC of the body. Radiation has long been proven to destroy fâst multiplying cells (e.g, cancer) in hopes of dc~LIùyi.lg or plc~ ing the spread of the disease. Brachytherapy, which is the tre~trnen- of cancer at close rli~t~nros, is one 5 exarnple of the use of radiation for treating ~lice~s of the body. During bLachyLherapy, a raAioact;vc source or sources are positioned in the area r~eAin~ Llc ~1 -r ~ Depen~iin~ on the shape, size and delivery means of the radioactive sources, the sources are either kept pe m~n~ntly in the body or removed after a specific amount of time. Since p~rrn~n~nt irnplants are tiny seeds ~u~ oly 3mrn long and 0~rntn wide, the use of these seeds do not relate to the prescnt 10 inventiorL Consequently, the focus of this appliratinn will be on the field of t~ ~p ~ r i~
The terrn tt_.llpor~y impl~nt~ describes the procedure of maneuvering a ra~in~rtive source or sources to the hcaLL~ lL site uti~i7in~ a transport catheter or tube which has been prev ously placed in the vicinity of this h ~h~lcL.t site. Alternatively, the h ~5~uo-L catheter and t n~u.~y implant can ~imnl~n~ously be rnaneuvered to the ~e-~ ~ t site. In either ~ ;oll, after a 1~ sperifird period of tirne, these sources and the transport catheter or tube are removed from the body. Since the ~a~iioa~tive source or sources may C~CGuut~. a Lo~uO~15 path in various arteries, vcins, ducts, or the li}ce inside the body to reach the h ~ sitc, thc raAio~rt~ve source is usually ~ rhrd by some dcvicc to a flexible drivc m~mh~r~ This source and the drive m~n~her may be used many times, and, therefore must be able to with~n-i the many bends it e.~CO~L~LS
20 when it is 1~AeU~ r 1 to the hc~LL--e.-t site or removed thel~Lu~, without l,leal~il,g.
W O 96/40352 PCT~US96/08688 There are several devices on the marlcet in which radioactive sources are ~tt~rh~d to flexible drive m~nb~ rs Each of these devices is CO~ d in a different fashion and each has its limitations. Examples of these prior art d~ices are described in U.S. Pstents 4,819,618 a~d ~,141,486, both issued to Liprie as well as U.S. Patent 4, 861,520 iss~ed to van't Hoof~ The two Liprie patents describe a prlio~rtive element which is zlt~rh~A to a drive mcmber by means of a junction welded to the trive cable. The patent to van't Hooft describes an ay~aLL~ which attaches radioactive sources to a drive cable by means of a siff capsule welded into the end of the cable. Since the most resistive portion to flection of any flexible m~teriz~l such as a cable1 tube, or ~,vire is the sc,, ..~ ~ closest to the end, to join a capsule which is stiffer t~ this material 10 and welded onto its end would only add to the r~ t~nre to b~n~ling and would a l~ .ely effect maneuvering thc m5~t-~ri~1 through the body.
U.S. Patent S,08~,002 issued to Liprie describes an ultsa-thin high dose iridium source inrhl(~ecl within an ~v..~d hole drilled inside the end of a solid p~tinnm wire. Drilling a hole into a t}~ wire is ve~y ~iiffirlllt since the ~ ll depth t_e hole r~n be drilled is e~ual o d~lu~ seven times the outside ~ of the v.~rc. To drill a ho}e deeper than this is e~ .,.cly difficult due to the drif~g of the drill as it b~..uw~ the hole. This dri~ng can lead to a thinn;nE~ of the caYity walls which greatly .~,~es the chances of breakage. This l,.~g~
is o~en disast~ous, resulting in u~w~ tir,n t~ osu~ A larger outside will be needed to cc,...~ te for the drifting a~d still allow the walls of the cavity to be t_icl~
20 enough to wi~h~d stress. Us~ ~Lely, this larger ~ , t,~ wire might be too large to fit into many co~.cl. ;rl~ ~ a~as of the body. ~s r;ecrri~d in Lipric '002 one can drill a cavity inside a , solid wire, if one starts with an oversize wire and an oversize hole and then the whole as~c,,,bly is drawn down to the desire ;1~ . of the wire. Howe~,er, whenever a wire is drawn down, the assembly cont~inin~ the cavi~y elongues and the precisc pocitioninv of the r~rlio~tive core inside the asscmbly can become very difficult. Additionally, this larger ~i~m~t~r wire would rcsult in less flexibility and may not be able to be maneu~-ered to the h~t~ site.
Finally, U.S. Patent 5.~82,781 issued to Liprie employs tube, a backbone wire, a pure iridium core and a plug and draws down the entire assembly to form a tight seal between the housing m~t~ri~l and the backbone wire and the plug. Without this drawing down of the housing onto the backbone wire, radioactive flakes from the core would migrate throughout the inside of 10 the assembly wire, resulting in unwanted c~ ion This "drawing down" step would inc~c~i~i the costs and difficulty of ".~..,.r~ the source wire. Furthe~nore, sny "drawing down" step as d. i~ ,;bcd in U.S. Patent No. ~,084,002 and U.S. Patent No. 5,282,781 would not work on a memory lc~ia~u~L alloy. As soon as a memory resistant alloy had been drawn through a die, the alloy would resurne irs original shape. If the memory ~~ L~ll alloy was drawn beyond 1~ the ~hreshold of its elasticiry, then the memory l~sisl~L proper~es of the alloy would be dc.,h~ d.
Thus, there exists a need for a r~io~r~ive sourc~ wire that has all clLhc~lcly small ~i~rn~t~r and is fl~Yibl~ yet has s~lffiri~nt tensile strength to traverse a tc"luou~ route of bends and tUIDS without IJ,e~ g.
It is an object of ~e present invention to provide a srr~ source wire that is e.~hc~,,cly flexible and will allow the source to travel to the site of h~ .t without binding.
, W O 9G/l~ PCT~US96/08688 It is another object of the present invention to provide a source wire that is strong enough tO withstand the stresses placed upon the source, as it is maneuvered to and from the site of within the patient, without breaking.
Yet another object of the present invention is to provide an improved source wire design that inrl~ s a ~ - r~hA -;~m for relicving some of the stress encountered by the metal housing tube of the source wire as it is maneuvered to the ~ .lt site.
Still yet another object of the present invention is to provide an improved souFce wire that exhibits little or no memory retention when bent.
An a~ itionAl object of the present invention is to provide for h,~plo~1 m~thr~l~ of 10 11l~ r~c~ & source wires that would derrease the costs and ~ifficlllty in ...~ r;~ g source wires without c~rrificing the quality of the m~n~fAct~red source wire.
WO 9f/10~5?- PCT~U~3~,'0 ~UMMARY OF T~F TNVFNTrC~N
These and other deficiencies of the prior art are addressed by the present invention which is directed to a flexible source wire for the radiation tr~-~tm~nt of disease in which the source wire co~t~inc a radioactive core and is easily maneuvered to the site of hcahl~cnt through various cor.d~iLc in the body.
A flexible source wire is provided cont~ining a radioactive source that is capable of maneuvering through a tortuous narrow passage to a hc~l l .t site within the body. This source wire includes a thin flexible housing rube, housing therein a flexible b~rL bonP wire, wherein both the tube and the wire are corL,hu~Lcd ~om a m~ten~1 exhibi~ing little or no ~ O.y retention 10 when bent. A radioactive core is provided in the proximal end (i.e., the hcLhll~,..t end) of the thin flexible housing tube and abuts the ~lo~al end of the backbone wire. Both ends of the source wire are sealed and at least the y~O~Li~l end of the source wire is rounded to allow ease of movement as it travels rhrough the bends and tums in the body.
The flexible source wire dc-crrihed herein may have a backbone wire that is tapered at the 1~ end closest to the r~lio~tive core. The tapered end of the backbone wire t~ .I~I;II_t~ ~ next to the p~ rive core in a rounded area shaped like a ball. The radioactive core, psci*nnr~ within the housing tube, may exist openly within the hn--cing tube or may be loc~li7~d in an open-ended capsule or may be e .r,,~ by a thin-walled7 flexible m~tt~ri~l or coating that allows the passage of nc~hu.s.
One advantage of the present invention is that it provides a smaller ~1;;.1ll.~... source wire than is c . . c,lLly available.
W O 96/40352 PCTAUS9~ G88 Another fe~ture and advantage of the present invention is that the sourcc wire has a sufficicnt tensile strength and flexihility to wiL~L~d the strcsses enco~lh.ed when the source wire is maneuvered to the site of l~ r~l Yet another featurc and advantage of the present invention is that it provides a novel ",,~ icm for relieving some of the stress c.-co~ ,d by the metal housing tube as the source v~ire is maneuvered to the l.caL~ ,nr site.
Still yet another feature and advantagc of the present invention is that the source wire is made of a m~t~ri~l that can undergo a 1% strain with less than a 1% alteration in its original C~.,r~ll"~l .on.
A further featurc and advantage of thc present invention is that it providcs ,~ lov~d m~-thoric of m~nllf~rt?lnng source ~,vires that will save the m~n--f~rt?-rer time and money.
Adriit;C~n~i features and advantages of ~e il.~., ItiO-~ wil1 be desrribeA k.,~ck~arh~ which form the subject of the claims of the invention. It should be ~ t~.d by those skilled in thc art that the conce~ion and the specific embo~.lc~lL riicrlosed rnay be readily utilized as a basis 15 for modif~ying or ~kCisJning othcr ~hu~,Lul~s for car~ying out the same ~LuyGS~.~ of the prcsent il.ve~liol1. t should also be reaLi~d by those slcillcd in the art that such cq~valcnt co~hu.;hons do not depart from the spirit and scope of the invention as set forth in the clairns of the inventiorL
W O 96/40352 PCT~US96/08688 RRr~F n~cR~pllo~ OF lH~ ~F~A~Vn~GS
For a more complete lln~e~An~inV of the present invention, and the adva,l~gcs thcreof, ~cr~,,ence is now made to the following descriptions taken in conjunction with the Af~o~ yi~g drawings, in which:
5FIGURE 1 is a partial cross-section of one embodiment of a source wire showing a backbone wire and a radioactive core enclosed within a flexible housing tube;
FIGURE 2 is a partial cross-section of another emho~iment of a source wire showing a rariio~ctive core enclosed in a capsule within the flexible housing tube;
FIGURE 3 is a par~ial cross-section of another embodirnent of the present invention 10having a ra~inActive core in an open-ended capsule within a flexible housing tube;
FIGURE 4A is a partial cross-section of another ~mhoAim~nt of the present i"~ Llo~
having a tapered bAcl~hon~ w~re with a rounded area on the p.c ~.~al tip of the backbone wire;
FIGURE 4B shows the embodiment illl-c~t~d in FIGURE 4A where the backbone wire has altered its shape in ,~onse to stress;
15EIGURE 4C shows an embo~iim~nt having the tapered backbone wire illnstrated inFIGIJRE 4A but where the r~f3io~cnve core is placed directly ~rlto the housing tube rather than in an open-ended c~rs~
FIGIJRES ~A through C show a ~i~P.~ ic view of a source wire aIld what happens when the flexible housing tube breaks and the barL hon~ wire is not ~ rh~d to the inner surface 20of the housing tube;
CA 02222l49 l997-ll-25 W O ~f/10~ PCTrU5~6/08688 FIGURES SD and E show a Ai~ ;c view of a source wirc, with and without a break in thc housing tube, where the b~Ll~onr wire is ;~ rd to the inner surface of the housing tube;
FIGURE 6 shows a partial cross-section of a source wire positior~d in a heat sink before its p-u~..lal end is sealed; and FIGURE 7 shows a partial cross-section of a sourcc wirc Aaving a b~cl~hnn~ co...l..;ccd of a number of balls linked together by a thin wire, and a ~iis~rt-ve core coated with a neutron pe~n~ble m~t~ri~l within a flexible housing tube.
_ W O 96/40352 PCT~US9~'a&588 n~TArr Fn n~SCRTPTrON OF T~F~ FF~RRF~ MROr)IMl~NTS
Thc present invention relates to the design and manl-f~rnlre of improved source w*es for delivering radio~r~ivily to a site of L~ ...r .~t within the human body. Thc invention relates to 5 a novel source wire design that provides improved source wire flexibility and strength such that the h,~,.o~c~ source wire can survive the stress r~nrollns~red when it is subjected to the manip~ tior~c nr~.cccc~. y to maneuver the source wire to and from an intemal l.~atl..cllt site for the locali7~d delivery of radiauon to ~ice~c~d tissue. The present invention may be used to treat cancer, st~nosic~ or other diseases of the body. The use of the present invention in the t~,GL~ L
10 of stenosis is ri~sr~ibed in co-pcnding U.S. patent application entitled "Method and A~G~GL~a for Treating Stenosis," Serial No. 08n20,681, and is hereby i,lcc.l~Olatcd by .cÇ~ c hereirL
R~!fi~ing now to the drawings, and initially to FIGU~E 1, it is .~ .h~ d that the Figures, or d~dWil~g~, are not int~-n-iÇd to be to scale. For example, purely for the sake of grcater clarity in the ~ wh~s, wall thirl~n~cc and Sp?~ingc are not ~imen~ion~d as they actually exist 15 in the ~cc~hlecl embo~iim~ntc Furthermore, the lengths of the bacLL.onc wire and the rarlio~c*ve core are illu~G~d out of ~lopolLion to how they actually exist, put~ly for the sake of clarity.
~ IGURE I ill--ct~t~c a first embon'im~nt of a source wire 10. Among the co~onc.~
of the source wire 10 is a th~, elongated, flexible meta~ ho!lcin~ tuToe 120. Since this houcing 20 tube 120 is used to maneuver the radioactive core to a remote h~ah~c~L site, the length of the tube must be a~-q~lat~ to reach the hc~ ..t site when the source wire 10 is inserted through a W O 96/40352 PCTrUS~6/08~8 catheter im~l~nt~d in a palient's body for that purpose- Typically, tube 120 will havc a length of at least 100 cm and may ex2end for a much greater n'iS~Hnre Additionally, the outside A;..~.~ 1, of tube 120 will range from about 0.012" to aboul 0.018" and is preferably about 0.014". Tube 120 has thin walls, with a wall thirl~nt~ rangIng from about 0.0020" to about 50.0035" arld is preferably aboul 0.0025". The internal d-- ~ rer of the housing tubc ranges from about 0.008" to about 0.014" and is preferably about 0.0093".
S-~ectin~ the size of 2hc metal housing tube 120 1G.1UUCS that onc balance the h~C1~tGd traurna to the tissue through which source wire 10 will pass, with the ~-~c.c~e in tensile strength and t lon~ti~ n of larger tubing. The tubing to be used should be as small as practical and still 10have the tensile strength, flexibility, and t-lon~tion properties rl~c~,~H.y to withstand the .G~at . s put upon the source uire while it is ~ r_d Li~lou~uul the body.
P.G~.~bly, housing tube 120 is co~hu~ d from a mHt~ that can accept up to a 1%
strain with less than a 1% altera2ion i~ its original shape (i.e., a m~t~r-~l that exhibits little or no u~ ret~nti~ n when bent). Most met Is such as st~inle~ steel will incur a F~
15Hlte~tiorl in its original sha~c when auL~ic~hd to as lit~lc as a 0.1% st~in An example of a m~t~l that exhibits little or no memory retention when beut is Tinel Alloy BB, a l;L~ .;, ..inickel alloy, ~ rH~ d by Raychem Corporation, Me~lo Par~, C~lif~ Another cu..,..~,..,islly avai}able alloy ~th sirnilar ~)~opC~LiCs is Nitinol~) m~nllfach~red by Shape Memory Alloys, Surmyvale, ~lift~rni~ Tinel Alloy BB, and other such nickel/l;LH.II;~.... alloys, are 20 c..,l..~ C(l of about equal qllantiti~s of nickel and l;lH~ I Il such as an alloy co~ osed of about 55% nickel a~d about 45% I;L;~rll;~lll.
W O 96/40352 PCT~US96/086~8 Tube 120 has two ends, one of which will llltim~tr~ly co..c~ e the proxirnal end 140 and the other the distal end 1~0 of source ~sre 10. The proximal end 140 should be rounded to f~rilit~tr the movement of source wsre 10 through tne bends and turns of the v~C~ nlre~ or other L~caLlllLllt sites.
Another colll~o~L.lL of source wire 10 is a flexible backbone wire 130 which has a di~m~t~r slightly less than the inner ~ mftrr of housing tube 120, and is preferably about 0.0085" in fii~mer~r. Since the backbone wire 130 has a smaller rli~mr~t~r th n the inner ~;z....rt~
of the housing tube 120, a small gap 175 will exist b~ .. the outer surface of the b~rl bonr wirc 130 and the inner surface of the housing tube 120. Backbone wire 130 is positioned within the lumen of metal tube 120 from the distal end 150 of tube 120 and eYtr.~ling virtually the entire length of the tube except for a portion of tube 120 at the ~u~uh~lal cnd which will ~cc..~ odate the radioactive core 160. Backbone wire 130 will generally be secured to the distsl end 1~0 of housing tube 120 by weld 165, or some other means of ~tr~rhm~ ~)t such 8s gluing.
In addition, backbone wire 130 may be affixed to the inner surface of housing tube 12û at a 1~5 variety of ;~ .,. r-~ sites 168.
An ~l,UO..~ filnrtinn of ba~L ho~.r wire 130 is to r ~ e the fl~Yibility of source wire 10. The outer metal housing tube 120 hss a ccrtain degree of flr~Yi~hjlity, but in the absence of inner support wûuld tend to bend or buclde and rnay even collapse when trsnsversing tight turns through a catheter. That tendency is prevented by the ~.~se~ce of the internal b~-Ll~lr wire 130. I~us, the b~rlho~ wire 130, like the housing tube 120, must be co.,.ro~d of a very flexible material with sufficieM tensile strength to undergo the s~ess enc.,~ ,d when the W O ~6/~ pcTrus96~c6cs~B
source wire 10 is ",ar,~,u~..d to a h~Lu~ l site ~...efio.c, backbone wire 130 should be cor.ah lcted of a material witn ~..,pc.li.s similar to that of housing tube 120 in fact, if tnc - backbone ~ire 130 is welded to the distal end of tube 120 then the backbone wire 130 and tube 120 should be made of the same mz~r.~ l, for exarnple a ~ /nickel alloy as dr,, ;bed above.
For ease of initially inserting the 'o~LI vn~ wire 130 into the tube 120 and to allow greater pivoting of the assembly while .~,duci..g stress to the housing m~ter~1, the proximal end 170 of the backbone wire 130 is rounded Other configurations of bacL~bone wire 130 will be ~icCll~sen in the dcscription of other e...'w~ of tne i..~...hon Athirt COnl~Oll~ of sourcewire 10isara~iio~ctivecore 160. ~iio~tivecore 160may be coli.poscd of a variety of different ratioisotupcs such as Ir-192, Cs-137, Co-57, Co-60, Sr-89, Sr-90, P-32, Y-90, Au-198, I-12~, Pd-103, Se-75, Ru-106, Y~169, or Am-241. However, the CI;LlC;l embodiu...-L of core 160 will consist of a ~ y pure iridiurn, wnich has been i7T~ t-d in a nuclear reactor to produce Ir-192 of a p.~ d strength ~Lo~ L~ to its weight Core 160 has a ~ that is srnaller than the inner h7;,....~ of housing tube 120.
Core 160 is inseted in tne ~-v~u~l end of the lurnen of tube 120 and is pushed inward until core 160 abuts the rounded end 170 of ~L h -n~ wire 130. A plu~Llity of r~n'in~rtive cores 160 may also be employed in the present iIlvention.
A l .ch..~ embodirnent of the u~..lhou has a r~iio~tive core 160 of a~ least 20 mm i~ length that ernits a~out 380 keV of energy. By a~lcadi~, out the 380 keV ernitted over at lea(st a 20 mm ~ f~ the core 160 is directly visible with a fluo,uscopc. ~ithnugh the energy ernitted by the r~ o~~tive core 160 and the length of the source of ra~io~cl;vi~y will vary with W O 96/40352 PCTAUS~Gi~~88 di~r~ t embodiments of the invention, the pL~r~ d embodime.lt v~ill have a radioactive core that can be seen with a fluo~u~copc. This feature provides a distinct advantage over the CUL1~LLI~Y
available sources which have a radioactive core of 10 mm or less in length. l~ese point sources emit the equivalent 380 keV of energy in a less ~;ml~d manner. Tnus the ernitted energy hits 5 the fluoroscope directly and overrides its abiliy to visualize the ~lioactive source. Therefore, the radioactive cores of c~.~ available source ~ires are not directly visible with a flUULO ..,ope and must be positioned inside the body without the visual con~ ion allowed with the present invention.
A preferred em~oA;m~Qt of the invention has a core 160 that is about 0.005" in ~ ..,rt~ ., Thus, in this embodiment the core 160 is s~al1er in ~ rl~l tnan the baclcbone ~vire 130 thereby providing incle~sed flexibility to the ~.u~uu~1 end of the source t~re 10, In fact, when core 160 has a smaller ~ t~ than bacl;bone wire 130, the end of the source wire houstrg core 160 will have more fl~ibility tnan the por~ion of tne source wire co.,~ the l~ac~bone wire 130. This .,~cle~sed fleYihility at the front end of the source tvire ~~ill allow the source t ~re to 15 easier through tight bends and c~ves.
Once the core 160 has bcen inserted into source wirc 10 thc ~.ox~ual end 140 of tube 120 is rounded using an arc welder, such as a ~ , inert gas (or TIG) welter. nle purpose of tbe rounded end of source wire 10 is to seal radioactive core 160 within the interior of tu'oc 120 aIld to h-ilit~t~ the adv~r~ l of the source wire 10 through an irnplanted catneter to the h~5hu~-1t site.
CA 02222l49 l997-ll-25 W O ~6/1~ PCTAUS~r'~$~88 FIGURE 2 illus2rates a second embodiment 20 of the present invention. This embor~ t is similar in many le.~cc,l~ to the embodiment shown in FIGURE; 1 and will have - the samc .c~ ce nurnerals ~ the l~ cc~ , clr.. ~ pictured in FIGURE 1. This embodiment also has an elongated cylindrical metal housing tube 120, similar in dimensions and 5 cha,acL~,istics to the rube described with respect to FIGURE 1. A backbone wire 130, preferably constructed from the same m~terj~l as the housing tube 120, is introduced to the inrerior of the housing tube 120 and extends from the distal end 150 thereof to an area positioned several millim~ters (preferably about 32 mm) from the ~lu;cinlal end 140 of the tube 120. The ~acl~bc,.lc wire 130 is provided with rounded end 170 to aid its mo~.".l~"lL within the tube 120 10 ~nd to allow greater pivo~ing of the assembly while reducing stress to the housing m~tl~ri~l A raAio~rr~ve core 160 is enclosed within a t~un-w lled capsule 220. This capsule 220 is inserted into tube 120 so that the distal end 230 of capsule 220 abuts the rounded end 170 of the backbone wire 130. The capsule 220 should bc flexible and the wall of capsule 220 should be m~rl--f~rnlred to a thir~n~ ss of b.,l~..e.,.l 0.001" and 0.0005". This thin capsule 220 should be 1~ made of a m~tori~! that allows the passage of n~.,huns without obtairung sigmficant r~n'io~c~ y itself. Thus, should tne c~psule material become r~n'io~ctive by neutron flux, the ~5~teriAI and any co.~ ;"A~r~ of that material should have a short half-life as coll,~A,~,d to the ~lio~ctive core 160. It is ~ipulL~ that the capsule 220 should cmit less than 10% of the r~n'i~tion emitted by core 160.
The capsule 220 may be made in a varic~y of ways. For ~ le. it may be made from a carbon fil:~rn~nt sealed with epoxy on both ends, or it may be made of a very thin metallic W O ~/4D~ PCTrUS96/08688 ~..hs~ r (e.g., ~ .;u...~ a high purit,v al~nnin--m such as ~h~ . 1100, pl~tin--m or the tit~nil~m/nickel alloy ~lesrri~ed previously) with both ends welded, soldered, or glued closed. In a preferred embodiment the iridium will be -n~ps~ ted before it is i~i~te~ to fonn lr-192 and the capsule 220 will allow the passage of n~.lL,vns to im~ t~ the core 160.
Once the capsule 220 has been posit;on~d within housing tube 120 ~ r~nt to backbone wire 130 an optional plug 250 may be inserted next to the proximal end 225 of capsule 220.
When the desired co..lponc~ have been a{~p. u~L-aL~Iy rocition~r1 the p~u~ih~lal end 140 of source wire 20 is sealed and rounded as described above. A ~.~,f~ d embodiment of the invcntion will seal p.ukh~al end 140 by fusing the proximal end oftube 120 with an arc welder (when plug 250 10 is not ~cuL~u.alcd into the source wire). Al~.~li~ly, the ~-u~ al end of source wire 20 can be sealed and rounded by welding, glumg, or soldering the plug 250 to the plU~Lhl~al end of tube I20 and ruu~l(lil g the ~lo~.al end with a router, grinder, sander, etc. to achieve a rounded end 140.
The p.~r~..cd emboclim~nt of capsule 220 will be rounded on ~oth ends. The purpose of 1~ having a rounded distal end 230 of capsule 220 is to allow grea~cr ~ivuli~ of the source wire 20 while l'dU~ lg stress to the housing ms t~ris~l at the j u-lcLu ~ of ~ f 'L ~ wire 130 and capsule 220. ~l~hl)ugh the ~.cre..cd ernho~im~nt has a single capsule 220, a plurality of c~ps~ s could be employed in the present in ~ention, or a plurality of cores 160 could be illcùu~Ola~d within a single capsule 220.
FIGURE 3 ill~ an ~ tion~l embodiment of a flexi~le source wire 30, this sourc~
wire is similar in most respects to the ernho~ shown in FIGURES 1 and 2. In this CA 02222l49 l997-ll-25 W O 9G/1~ PCTAUS96/08688 embo~lim~nt, similar clr~ in FIGURE 1 will have thc same rcf~ .nce n--rn~pl~ as their ~s~ccli~e ck~ in FIGUFUE 3. FIGUFUE 3 shows a source wire in which ~ rtive core 160 is located within an open-ended capsule ;30. This capsule 330 is like capsule 220, except that it is open on the end EJlukhl~dLe to the plu~hl~al end of the source wire 30. When open-ended capsule 330 is used, an op~ional plug 350 may be placed over the open end of capsule 330 before it is sealed. Open ended capsule 330 may be sealed by welding the proximal end of the capsule 330 to the ~lu~ al end of the tube 120, if the c2psule 330 and the tube 120 are made of the szme m~t~ l Altern2tively, if plug 350 is used then plug 35û may be co,,l,uosed of the same material as tube 120 and mav thus be welded to the ,UlU~ al end 140 of tube 120. However, ~ltem~*ve means of sealing the ylu~i~llal end of capsule 330 and tube 120 may also be employed.
Open-ended capsule 330, like capsule 220 shown in FIGURE Z, is ~uo~;l;o..~d ~,lj,.,~..l to rounded end 170 of backbone wire 130. The distal end 340 of open-ended capsule 330 is ro~mded to f~eil;t~t~ bending of source wire 30 at the juncture of b~cl~horP~ wire 130 and 1~ open-ended capsule 330.
FIGURE 7 ill~ s an ~ ; v~ embodiment of tbe source wire where the b~r l ho- ~
wire consists of a series of b~ll-like ~L~u~ S 705 i~L..or...~ ~d with short lengths of a thin wire 708. This configuratior provides ih~cle se1 fl~Yibility Ih~uu~lluul the length of the source wire with each ball acting as a pivoting agent and relieving stress to the wall of housing tube 120. FIGURE 7 also shows r~ rrive source 160 having a thin coat~Dg 712 of a neutron pe~m~ble m~t~ri~l The coa~ing 712 may be an ele.,~ul~lated coating of a m~teri~l such as gold, l, pl~tinllm, ect. Coating 712 may also be made of non-m~ot~ c matesials such as a hardening agent (e.g., glue or acrylic). Coating 712 may be applied to core 160 by l,.u:,l~g, dipping, p&inting or mo~ec~ rly bonding the coating m5?teri~l tO the out~r surface of core 160.
Coating 712 will completely cover the outside surface of core 160 and ~~ill function to prevent 5 thc flaking of the radioactive core 160.
FIGURE 4A shows a ~ d embodiment of the present invention. This embodiment of a flexible source wire 40 is similar in many respects to the embcr7im~nT~ shown in FIGURES
1 and 3. Therefore the rl~ in FIGURE 4 corresponding to similar elc ~ in FIGURES
1 and 3 are given the sasne ,ef~_.c.-ce n-~m~ ~lc as their ~y-~hve ei ~ in FIGURES I and 10 3. The embo~iim~nt illustrated in FIGURE 4A has a ~ .c.l~ corlfi~ on of its L,ac~l.ol,e wire to that sho vn in any of the other ~nbo~1im~ntc and inrlu~1es an ~lLayc~d por~on 430, a tapered portion 440, and a rounded a 450. The bacLhone wire of source uire 40 is tapered at its plu~ihllal end. Back~one wLre 420 is tapered over a~*,oxi~ ly the last 0.5" to 2.0" of its y.u~llal en~ Thc taper 440 gOGc from a 100% width of the ~ul~.~ b~r~ on.o wire 430 to about 30% to 60% of the width of the ~La~ d b~rl hon~ wire 430 as the taper exteslds toward the ~.u~ end of source w~re 40. Taper 440 of bacLbone wire 420 l~ S in a rounded asea 450, where .~ded arca 450 a$JL/lu~ ,S Ihc shape of a ball. This confi~;ulahon allows the source wire 40 to release somc of the strcs~s on the outer wall of housmg tube 120 when the source wire bends to LLa~ C a tight comer. In fact the stress placcd on rounded area 450 and 20 t~ncl~t~d to backbone wire 420 will cause the b~cl~hon~ wirc to crurnple along the tapered area as ill~ tf ~ in FIGURE 4B. However, since Ihe bacLbonf wire 420 is made from a flexiblc W O 96/40352 PCT~US96/08688 m~r~ l that exhibits little or no memory re2ention when it is bent, or more specifir~lly a m~t~l that can accept up to a 1% strain with less than a 1% ~It~tion in its original shape, the backbone wire 420 will resurne its original shape when the stress is removed and the sourcc u ire ha~ C5 a straight p~s~gç l~e novel design of backbone wire 420 increases the flrYihility and S maneuverability of the source wire 40, as well as decreasing the stress on the wall of housing ~ube 120. By dc.,.c~shlg the stress on housing tube 120, this backbone design allows the use of a smaller lI,,.."r~. source wire than is currently available.
An optional feature of each of the source wire emboflim~ntc is to attach the bacLl~nc wire 130 or 420 to the inner surface of the housing tube 120 by weldirg, fusing, soldering, lû gluing, etc. Sites of att~rhm~nt 168 are shown in FIGURES 1~. These sites of ~tt~k"~ 168 provide an inte~al safety device that insures that if the housing lube 120 were to break that the r~io~rtive core 160 would not separate from the backbone wirc 130 and could be lcLLa~L~1 from the patient. FIGURES ~ ~ through C ill~l~t~ what happens if the housing tube 120 breaks and the backbone wire 130 is not ~r~d to the inner surface of tube 120. FIGURE 513 shows 1~ where tube 120 has broken and FIGURE ~C shows how the r~ o~ctive core 160 would be left in the patient when the bAfL hol~ wire 130 was ,~ In co..l .,.~, when b~rL hon~o wire 130 is ~tt~ril~d to the i$mer surface of tube 120 at ~ r~ sites 168, as seen in FIGURE ~D, if the metal housing tube 120 brcaks at any point distal to ~tt~rhm~nt sites 168 then the radioactivc core- 160 will still be ;~ d to the bdcLho~ wire 130 and will be lelldl l~ d from the patient 20 when the ba~LI..~ wire 130 is withdrawn, as seen in FIGURE ~;E.
W O 96/40352 PCT~US96/08688 Another optional feature of the source wircs described herein is to provide a seal 178 between the inner surface of housing tube 120 and backbone wire 130 by welding, fusing, soldering, gluing, etc. the backbone wire to the interior surface of housing tube 120. This seal 178 could also scrve as an ~chm~nt site 168.
Seal 178 may be made by a number of m~tho~l~ One such method would be to thread the backbone wire 130 through the length of the housing tube. The distal end of the wire would be marked at the point where the p,uxi",al end of the wire is flush with the pLUAilllal end of the housing tube 120. ~e backbone wire would then be pushed forward and a small amount of slow drying epoxy placed around the circumference of the backbone wire 130 about two cf ~ s 10 from the proximal end of the wire. Once the epoxy is added tû the wire, the wire would be pulled back into the hûusing tube until the mark ûn the distal end e~nr~ from the distal end of the housing tube the ~lu~-;ate ~ t~n~c, preferably about 32 mm. The backbone wire would then be cut flush with the distal end of the wire and welded to the housing tube to seal the distal end ûf the backbone wire 130. Any glue ~lh~ng to the internal surface ûf the ~luxilllal portion 1~ of the housing tube, where the epoxied backbone wire was drawn through the housing tube, wûuld be reemed out before the r~iin~ctive corc 160 was inserted into t_e backbone wire.
An al~ method of producing a seal 178 would be to follow the ,uluccdu~ t scribed abûve, except to allow the epoxy tû dry before drawing the ~)lU~illlal end ûf the backboYlc wire back into the housing tube. The epoxy ring would then be ground or sanded to fit snugly within 20 the housing tube 120.
=
W O 96/40352 PCT~US~6/08688 Seal 178 would encircle backbone wire 130 closing off gap 17~ and thcreby ~JlG~ ;.Ug any "flakes" from the radioactive core 160 from migr~ring through gap 175 1G~L~ 1 the bA~-~ l.on~
- wire 130 and the inner surface of housing tube 120. Seal 178 is typically illcoll~ulaLed into ~mho~iim~ortc of the invention where radioactive core 160 is not Inrlssed in a capsule or S enr~rsul~tt~d as seen in FIGURE 1 and FIGIJRE 4C.
Seal 178 and Att~rhm~rlt site 168 are produced in a si~r.ular manner. The major difference between seal 178 and ~ttz-rhm~nt site 168 is that ~rr~rhm~rlt site 168 may only attach a small 5~ of the ~ , of b~rkho~ wire 130 to the inner su;face of the housing tube 120.
T.hus, gap 175 may not be totally closed all around the bac~bol~c wire 130 when the b~cl~h~nr wire 130 is only attArhrd to the inner surface of tube 1~0 at a small portion of its circumference as may happen in fc~ing an ~ rl"~.r.,l site.
Yet another optional feature of the source wires rl~sr~ihcd herein (but not shown) would be to coat the exterior surface of the source wire with a non-o~i~i7in~ agent, such as gold In one embodiment of the present inventiorl, a thin gold layer (from ap~lu~ ly 1 to 10 microns 1~ tl~ick) would be elc~hoplated over the outer surface of metal tube 120, or at least that portion of the surface o~ lyi~lg the r~ ~ve core 160 and preferably e ~ l~ .-1;. ,g over the ~J~U~hllal end 140 of the source wire. F~Lh.,.~U-C, the gold coating of the source wire would preferably be done prior to loading the r~rlio~rtive core 160 into ho~sing tube 120.
T.he f~hrir~ti~n of thc source wires shown in FIGURES 14 is ~esr~ibed below. The first 20 stcp in the . ~ ~A~ r~ . G of the d~Cr i~ed source wires is to obtain the metal tubing that will be used to rnake the housing tube 120. Once the tubing is acquired, a c~lihr~ted rnicrometer for PCT/U596/OY6gB
FLEXIBI,E SOURCE WIRE FOR LOC,~.r7.F.n INTERNAL ~RRADI~TION OF TISSUE
RFFFRF~CF T~ RFT ATF~ T~Al~FNT APPrTCAl~ONS
The present application is a c o. ~ l ;on-in-part of U.S . application Seriai No. 08/257,045 filcd June 8, 1994 and entitied "Flexible Source Wire for Radiation T~ t of Diseases," the entire coments and ~licclosllre of wi~ich are hereby specifically il~co~oldL_d by ~c~c~cc.
FTT-T.n OF lH~ irrVF~O~
The present invention relates generaily to rarlio~rrive source wires used to i~lddidle body tissue in the h~ e-~L of disease. More particulariy, the present invention relates to the use of an clon~r~d r~;ioartive source w~re with ~Ledsed fiexibility for the loc~li7~d delivery of r;3~i~tion to di~e~eA tissue.
1~
W O 9-~40~2 PCT~US~G,'~8B
RACKGROUI~D OF T~F lNV~NTrON
Radiation is used to treat cancer and other f~i~e~seC of the body. Radiation has long been proven to destroy fâst multiplying cells (e.g, cancer) in hopes of dc~LIùyi.lg or plc~ ing the spread of the disease. Brachytherapy, which is the tre~trnen- of cancer at close rli~t~nros, is one 5 exarnple of the use of radiation for treating ~lice~s of the body. During bLachyLherapy, a raAioact;vc source or sources are positioned in the area r~eAin~ Llc ~1 -r ~ Depen~iin~ on the shape, size and delivery means of the radioactive sources, the sources are either kept pe m~n~ntly in the body or removed after a specific amount of time. Since p~rrn~n~nt irnplants are tiny seeds ~u~ oly 3mrn long and 0~rntn wide, the use of these seeds do not relate to the prescnt 10 inventiorL Consequently, the focus of this appliratinn will be on the field of t~ ~p ~ r i~
The terrn tt_.llpor~y impl~nt~ describes the procedure of maneuvering a ra~in~rtive source or sources to the hcaLL~ lL site uti~i7in~ a transport catheter or tube which has been prev ously placed in the vicinity of this h ~h~lcL.t site. Alternatively, the h ~5~uo-L catheter and t n~u.~y implant can ~imnl~n~ously be rnaneuvered to the ~e-~ ~ t site. In either ~ ;oll, after a 1~ sperifird period of tirne, these sources and the transport catheter or tube are removed from the body. Since the ~a~iioa~tive source or sources may C~CGuut~. a Lo~uO~15 path in various arteries, vcins, ducts, or the li}ce inside the body to reach the h ~ sitc, thc raAio~rt~ve source is usually ~ rhrd by some dcvicc to a flexible drivc m~mh~r~ This source and the drive m~n~her may be used many times, and, therefore must be able to with~n-i the many bends it e.~CO~L~LS
20 when it is 1~AeU~ r 1 to the hc~LL--e.-t site or removed thel~Lu~, without l,leal~il,g.
W O 96/40352 PCT~US96/08688 There are several devices on the marlcet in which radioactive sources are ~tt~rh~d to flexible drive m~nb~ rs Each of these devices is CO~ d in a different fashion and each has its limitations. Examples of these prior art d~ices are described in U.S. Pstents 4,819,618 a~d ~,141,486, both issued to Liprie as well as U.S. Patent 4, 861,520 iss~ed to van't Hoof~ The two Liprie patents describe a prlio~rtive element which is zlt~rh~A to a drive mcmber by means of a junction welded to the trive cable. The patent to van't Hooft describes an ay~aLL~ which attaches radioactive sources to a drive cable by means of a siff capsule welded into the end of the cable. Since the most resistive portion to flection of any flexible m~teriz~l such as a cable1 tube, or ~,vire is the sc,, ..~ ~ closest to the end, to join a capsule which is stiffer t~ this material 10 and welded onto its end would only add to the r~ t~nre to b~n~ling and would a l~ .ely effect maneuvering thc m5~t-~ri~1 through the body.
U.S. Patent S,08~,002 issued to Liprie describes an ultsa-thin high dose iridium source inrhl(~ecl within an ~v..~d hole drilled inside the end of a solid p~tinnm wire. Drilling a hole into a t}~ wire is ve~y ~iiffirlllt since the ~ ll depth t_e hole r~n be drilled is e~ual o d~lu~ seven times the outside ~ of the v.~rc. To drill a ho}e deeper than this is e~ .,.cly difficult due to the drif~g of the drill as it b~..uw~ the hole. This dri~ng can lead to a thinn;nE~ of the caYity walls which greatly .~,~es the chances of breakage. This l,.~g~
is o~en disast~ous, resulting in u~w~ tir,n t~ osu~ A larger outside will be needed to cc,...~ te for the drifting a~d still allow the walls of the cavity to be t_icl~
20 enough to wi~h~d stress. Us~ ~Lely, this larger ~ , t,~ wire might be too large to fit into many co~.cl. ;rl~ ~ a~as of the body. ~s r;ecrri~d in Lipric '002 one can drill a cavity inside a , solid wire, if one starts with an oversize wire and an oversize hole and then the whole as~c,,,bly is drawn down to the desire ;1~ . of the wire. Howe~,er, whenever a wire is drawn down, the assembly cont~inin~ the cavi~y elongues and the precisc pocitioninv of the r~rlio~tive core inside the asscmbly can become very difficult. Additionally, this larger ~i~m~t~r wire would rcsult in less flexibility and may not be able to be maneu~-ered to the h~t~ site.
Finally, U.S. Patent 5.~82,781 issued to Liprie employs tube, a backbone wire, a pure iridium core and a plug and draws down the entire assembly to form a tight seal between the housing m~t~ri~l and the backbone wire and the plug. Without this drawing down of the housing onto the backbone wire, radioactive flakes from the core would migrate throughout the inside of 10 the assembly wire, resulting in unwanted c~ ion This "drawing down" step would inc~c~i~i the costs and difficulty of ".~..,.r~ the source wire. Furthe~nore, sny "drawing down" step as d. i~ ,;bcd in U.S. Patent No. ~,084,002 and U.S. Patent No. 5,282,781 would not work on a memory lc~ia~u~L alloy. As soon as a memory resistant alloy had been drawn through a die, the alloy would resurne irs original shape. If the memory ~~ L~ll alloy was drawn beyond 1~ the ~hreshold of its elasticiry, then the memory l~sisl~L proper~es of the alloy would be dc.,h~ d.
Thus, there exists a need for a r~io~r~ive sourc~ wire that has all clLhc~lcly small ~i~rn~t~r and is fl~Yibl~ yet has s~lffiri~nt tensile strength to traverse a tc"luou~ route of bends and tUIDS without IJ,e~ g.
It is an object of ~e present invention to provide a srr~ source wire that is e.~hc~,,cly flexible and will allow the source to travel to the site of h~ .t without binding.
, W O 9G/l~ PCT~US96/08688 It is another object of the present invention to provide a source wire that is strong enough tO withstand the stresses placed upon the source, as it is maneuvered to and from the site of within the patient, without breaking.
Yet another object of the present invention is to provide an improved source wire design that inrl~ s a ~ - r~hA -;~m for relicving some of the stress encountered by the metal housing tube of the source wire as it is maneuvered to the ~ .lt site.
Still yet another object of the present invention is to provide an improved souFce wire that exhibits little or no memory retention when bent.
An a~ itionAl object of the present invention is to provide for h,~plo~1 m~thr~l~ of 10 11l~ r~c~ & source wires that would derrease the costs and ~ifficlllty in ...~ r;~ g source wires without c~rrificing the quality of the m~n~fAct~red source wire.
WO 9f/10~5?- PCT~U~3~,'0 ~UMMARY OF T~F TNVFNTrC~N
These and other deficiencies of the prior art are addressed by the present invention which is directed to a flexible source wire for the radiation tr~-~tm~nt of disease in which the source wire co~t~inc a radioactive core and is easily maneuvered to the site of hcahl~cnt through various cor.d~iLc in the body.
A flexible source wire is provided cont~ining a radioactive source that is capable of maneuvering through a tortuous narrow passage to a hc~l l .t site within the body. This source wire includes a thin flexible housing rube, housing therein a flexible b~rL bonP wire, wherein both the tube and the wire are corL,hu~Lcd ~om a m~ten~1 exhibi~ing little or no ~ O.y retention 10 when bent. A radioactive core is provided in the proximal end (i.e., the hcLhll~,..t end) of the thin flexible housing tube and abuts the ~lo~al end of the backbone wire. Both ends of the source wire are sealed and at least the y~O~Li~l end of the source wire is rounded to allow ease of movement as it travels rhrough the bends and tums in the body.
The flexible source wire dc-crrihed herein may have a backbone wire that is tapered at the 1~ end closest to the r~lio~tive core. The tapered end of the backbone wire t~ .I~I;II_t~ ~ next to the p~ rive core in a rounded area shaped like a ball. The radioactive core, psci*nnr~ within the housing tube, may exist openly within the hn--cing tube or may be loc~li7~d in an open-ended capsule or may be e .r,,~ by a thin-walled7 flexible m~tt~ri~l or coating that allows the passage of nc~hu.s.
One advantage of the present invention is that it provides a smaller ~1;;.1ll.~... source wire than is c . . c,lLly available.
W O 96/40352 PCTAUS9~ G88 Another fe~ture and advantage of the present invention is that the sourcc wire has a sufficicnt tensile strength and flexihility to wiL~L~d the strcsses enco~lh.ed when the source wire is maneuvered to the site of l~ r~l Yet another featurc and advantage of the present invention is that it provides a novel ",,~ icm for relieving some of the stress c.-co~ ,d by the metal housing tube as the source v~ire is maneuvered to the l.caL~ ,nr site.
Still yet another feature and advantagc of the present invention is that the source wire is made of a m~t~ri~l that can undergo a 1% strain with less than a 1% alteration in its original C~.,r~ll"~l .on.
A further featurc and advantage of thc present invention is that it providcs ,~ lov~d m~-thoric of m~nllf~rt?lnng source ~,vires that will save the m~n--f~rt?-rer time and money.
Adriit;C~n~i features and advantages of ~e il.~., ItiO-~ wil1 be desrribeA k.,~ck~arh~ which form the subject of the claims of the invention. It should be ~ t~.d by those skilled in thc art that the conce~ion and the specific embo~.lc~lL riicrlosed rnay be readily utilized as a basis 15 for modif~ying or ~kCisJning othcr ~hu~,Lul~s for car~ying out the same ~LuyGS~.~ of the prcsent il.ve~liol1. t should also be reaLi~d by those slcillcd in the art that such cq~valcnt co~hu.;hons do not depart from the spirit and scope of the invention as set forth in the clairns of the inventiorL
W O 96/40352 PCT~US96/08688 RRr~F n~cR~pllo~ OF lH~ ~F~A~Vn~GS
For a more complete lln~e~An~inV of the present invention, and the adva,l~gcs thcreof, ~cr~,,ence is now made to the following descriptions taken in conjunction with the Af~o~ yi~g drawings, in which:
5FIGURE 1 is a partial cross-section of one embodiment of a source wire showing a backbone wire and a radioactive core enclosed within a flexible housing tube;
FIGURE 2 is a partial cross-section of another emho~iment of a source wire showing a rariio~ctive core enclosed in a capsule within the flexible housing tube;
FIGURE 3 is a par~ial cross-section of another embodirnent of the present invention 10having a ra~inActive core in an open-ended capsule within a flexible housing tube;
FIGURE 4A is a partial cross-section of another ~mhoAim~nt of the present i"~ Llo~
having a tapered bAcl~hon~ w~re with a rounded area on the p.c ~.~al tip of the backbone wire;
FIGURE 4B shows the embodiment illl-c~t~d in FIGURE 4A where the backbone wire has altered its shape in ,~onse to stress;
15EIGURE 4C shows an embo~iim~nt having the tapered backbone wire illnstrated inFIGIJRE 4A but where the r~f3io~cnve core is placed directly ~rlto the housing tube rather than in an open-ended c~rs~
FIGIJRES ~A through C show a ~i~P.~ ic view of a source wire aIld what happens when the flexible housing tube breaks and the barL hon~ wire is not ~ rh~d to the inner surface 20of the housing tube;
CA 02222l49 l997-ll-25 W O ~f/10~ PCTrU5~6/08688 FIGURES SD and E show a Ai~ ;c view of a source wirc, with and without a break in thc housing tube, where the b~Ll~onr wire is ;~ rd to the inner surface of the housing tube;
FIGURE 6 shows a partial cross-section of a source wire positior~d in a heat sink before its p-u~..lal end is sealed; and FIGURE 7 shows a partial cross-section of a sourcc wirc Aaving a b~cl~hnn~ co...l..;ccd of a number of balls linked together by a thin wire, and a ~iis~rt-ve core coated with a neutron pe~n~ble m~t~ri~l within a flexible housing tube.
_ W O 96/40352 PCT~US9~'a&588 n~TArr Fn n~SCRTPTrON OF T~F~ FF~RRF~ MROr)IMl~NTS
Thc present invention relates to the design and manl-f~rnlre of improved source w*es for delivering radio~r~ivily to a site of L~ ...r .~t within the human body. Thc invention relates to 5 a novel source wire design that provides improved source wire flexibility and strength such that the h,~,.o~c~ source wire can survive the stress r~nrollns~red when it is subjected to the manip~ tior~c nr~.cccc~. y to maneuver the source wire to and from an intemal l.~atl..cllt site for the locali7~d delivery of radiauon to ~ice~c~d tissue. The present invention may be used to treat cancer, st~nosic~ or other diseases of the body. The use of the present invention in the t~,GL~ L
10 of stenosis is ri~sr~ibed in co-pcnding U.S. patent application entitled "Method and A~G~GL~a for Treating Stenosis," Serial No. 08n20,681, and is hereby i,lcc.l~Olatcd by .cÇ~ c hereirL
R~!fi~ing now to the drawings, and initially to FIGU~E 1, it is .~ .h~ d that the Figures, or d~dWil~g~, are not int~-n-iÇd to be to scale. For example, purely for the sake of grcater clarity in the ~ wh~s, wall thirl~n~cc and Sp?~ingc are not ~imen~ion~d as they actually exist 15 in the ~cc~hlecl embo~iim~ntc Furthermore, the lengths of the bacLL.onc wire and the rarlio~c*ve core are illu~G~d out of ~lopolLion to how they actually exist, put~ly for the sake of clarity.
~ IGURE I ill--ct~t~c a first embon'im~nt of a source wire 10. Among the co~onc.~
of the source wire 10 is a th~, elongated, flexible meta~ ho!lcin~ tuToe 120. Since this houcing 20 tube 120 is used to maneuver the radioactive core to a remote h~ah~c~L site, the length of the tube must be a~-q~lat~ to reach the hc~ ..t site when the source wire 10 is inserted through a W O 96/40352 PCTrUS~6/08~8 catheter im~l~nt~d in a palient's body for that purpose- Typically, tube 120 will havc a length of at least 100 cm and may ex2end for a much greater n'iS~Hnre Additionally, the outside A;..~.~ 1, of tube 120 will range from about 0.012" to aboul 0.018" and is preferably about 0.014". Tube 120 has thin walls, with a wall thirl~nt~ rangIng from about 0.0020" to about 50.0035" arld is preferably aboul 0.0025". The internal d-- ~ rer of the housing tubc ranges from about 0.008" to about 0.014" and is preferably about 0.0093".
S-~ectin~ the size of 2hc metal housing tube 120 1G.1UUCS that onc balance the h~C1~tGd traurna to the tissue through which source wire 10 will pass, with the ~-~c.c~e in tensile strength and t lon~ti~ n of larger tubing. The tubing to be used should be as small as practical and still 10have the tensile strength, flexibility, and t-lon~tion properties rl~c~,~H.y to withstand the .G~at . s put upon the source uire while it is ~ r_d Li~lou~uul the body.
P.G~.~bly, housing tube 120 is co~hu~ d from a mHt~ that can accept up to a 1%
strain with less than a 1% altera2ion i~ its original shape (i.e., a m~t~r-~l that exhibits little or no u~ ret~nti~ n when bent). Most met Is such as st~inle~ steel will incur a F~
15Hlte~tiorl in its original sha~c when auL~ic~hd to as lit~lc as a 0.1% st~in An example of a m~t~l that exhibits little or no memory retention when beut is Tinel Alloy BB, a l;L~ .;, ..inickel alloy, ~ rH~ d by Raychem Corporation, Me~lo Par~, C~lif~ Another cu..,..~,..,islly avai}able alloy ~th sirnilar ~)~opC~LiCs is Nitinol~) m~nllfach~red by Shape Memory Alloys, Surmyvale, ~lift~rni~ Tinel Alloy BB, and other such nickel/l;LH.II;~.... alloys, are 20 c..,l..~ C(l of about equal qllantiti~s of nickel and l;lH~ I Il such as an alloy co~ osed of about 55% nickel a~d about 45% I;L;~rll;~lll.
W O 96/40352 PCT~US96/086~8 Tube 120 has two ends, one of which will llltim~tr~ly co..c~ e the proxirnal end 140 and the other the distal end 1~0 of source ~sre 10. The proximal end 140 should be rounded to f~rilit~tr the movement of source wsre 10 through tne bends and turns of the v~C~ nlre~ or other L~caLlllLllt sites.
Another colll~o~L.lL of source wire 10 is a flexible backbone wire 130 which has a di~m~t~r slightly less than the inner ~ mftrr of housing tube 120, and is preferably about 0.0085" in fii~mer~r. Since the backbone wire 130 has a smaller rli~mr~t~r th n the inner ~;z....rt~
of the housing tube 120, a small gap 175 will exist b~ .. the outer surface of the b~rl bonr wirc 130 and the inner surface of the housing tube 120. Backbone wire 130 is positioned within the lumen of metal tube 120 from the distal end 150 of tube 120 and eYtr.~ling virtually the entire length of the tube except for a portion of tube 120 at the ~u~uh~lal cnd which will ~cc..~ odate the radioactive core 160. Backbone wire 130 will generally be secured to the distsl end 1~0 of housing tube 120 by weld 165, or some other means of ~tr~rhm~ ~)t such 8s gluing.
In addition, backbone wire 130 may be affixed to the inner surface of housing tube 12û at a 1~5 variety of ;~ .,. r-~ sites 168.
An ~l,UO..~ filnrtinn of ba~L ho~.r wire 130 is to r ~ e the fl~Yibility of source wire 10. The outer metal housing tube 120 hss a ccrtain degree of flr~Yi~hjlity, but in the absence of inner support wûuld tend to bend or buclde and rnay even collapse when trsnsversing tight turns through a catheter. That tendency is prevented by the ~.~se~ce of the internal b~-Ll~lr wire 130. I~us, the b~rlho~ wire 130, like the housing tube 120, must be co.,.ro~d of a very flexible material with sufficieM tensile strength to undergo the s~ess enc.,~ ,d when the W O ~6/~ pcTrus96~c6cs~B
source wire 10 is ",ar,~,u~..d to a h~Lu~ l site ~...efio.c, backbone wire 130 should be cor.ah lcted of a material witn ~..,pc.li.s similar to that of housing tube 120 in fact, if tnc - backbone ~ire 130 is welded to the distal end of tube 120 then the backbone wire 130 and tube 120 should be made of the same mz~r.~ l, for exarnple a ~ /nickel alloy as dr,, ;bed above.
For ease of initially inserting the 'o~LI vn~ wire 130 into the tube 120 and to allow greater pivoting of the assembly while .~,duci..g stress to the housing m~ter~1, the proximal end 170 of the backbone wire 130 is rounded Other configurations of bacL~bone wire 130 will be ~icCll~sen in the dcscription of other e...'w~ of tne i..~...hon Athirt COnl~Oll~ of sourcewire 10isara~iio~ctivecore 160. ~iio~tivecore 160may be coli.poscd of a variety of different ratioisotupcs such as Ir-192, Cs-137, Co-57, Co-60, Sr-89, Sr-90, P-32, Y-90, Au-198, I-12~, Pd-103, Se-75, Ru-106, Y~169, or Am-241. However, the CI;LlC;l embodiu...-L of core 160 will consist of a ~ y pure iridiurn, wnich has been i7T~ t-d in a nuclear reactor to produce Ir-192 of a p.~ d strength ~Lo~ L~ to its weight Core 160 has a ~ that is srnaller than the inner h7;,....~ of housing tube 120.
Core 160 is inseted in tne ~-v~u~l end of the lurnen of tube 120 and is pushed inward until core 160 abuts the rounded end 170 of ~L h -n~ wire 130. A plu~Llity of r~n'in~rtive cores 160 may also be employed in the present iIlvention.
A l .ch..~ embodirnent of the u~..lhou has a r~iio~tive core 160 of a~ least 20 mm i~ length that ernits a~out 380 keV of energy. By a~lcadi~, out the 380 keV ernitted over at lea(st a 20 mm ~ f~ the core 160 is directly visible with a fluo,uscopc. ~ithnugh the energy ernitted by the r~ o~~tive core 160 and the length of the source of ra~io~cl;vi~y will vary with W O 96/40352 PCTAUS~Gi~~88 di~r~ t embodiments of the invention, the pL~r~ d embodime.lt v~ill have a radioactive core that can be seen with a fluo~u~copc. This feature provides a distinct advantage over the CUL1~LLI~Y
available sources which have a radioactive core of 10 mm or less in length. l~ese point sources emit the equivalent 380 keV of energy in a less ~;ml~d manner. Tnus the ernitted energy hits 5 the fluoroscope directly and overrides its abiliy to visualize the ~lioactive source. Therefore, the radioactive cores of c~.~ available source ~ires are not directly visible with a flUULO ..,ope and must be positioned inside the body without the visual con~ ion allowed with the present invention.
A preferred em~oA;m~Qt of the invention has a core 160 that is about 0.005" in ~ ..,rt~ ., Thus, in this embodiment the core 160 is s~al1er in ~ rl~l tnan the baclcbone ~vire 130 thereby providing incle~sed flexibility to the ~.u~uu~1 end of the source t~re 10, In fact, when core 160 has a smaller ~ t~ than bacl;bone wire 130, the end of the source wire houstrg core 160 will have more fl~ibility tnan the por~ion of tne source wire co.,~ the l~ac~bone wire 130. This .,~cle~sed fleYihility at the front end of the source tvire ~~ill allow the source t ~re to 15 easier through tight bends and c~ves.
Once the core 160 has bcen inserted into source wirc 10 thc ~.ox~ual end 140 of tube 120 is rounded using an arc welder, such as a ~ , inert gas (or TIG) welter. nle purpose of tbe rounded end of source wire 10 is to seal radioactive core 160 within the interior of tu'oc 120 aIld to h-ilit~t~ the adv~r~ l of the source wire 10 through an irnplanted catneter to the h~5hu~-1t site.
CA 02222l49 l997-ll-25 W O ~6/1~ PCTAUS~r'~$~88 FIGURE 2 illus2rates a second embodiment 20 of the present invention. This embor~ t is similar in many le.~cc,l~ to the embodiment shown in FIGURE; 1 and will have - the samc .c~ ce nurnerals ~ the l~ cc~ , clr.. ~ pictured in FIGURE 1. This embodiment also has an elongated cylindrical metal housing tube 120, similar in dimensions and 5 cha,acL~,istics to the rube described with respect to FIGURE 1. A backbone wire 130, preferably constructed from the same m~terj~l as the housing tube 120, is introduced to the inrerior of the housing tube 120 and extends from the distal end 150 thereof to an area positioned several millim~ters (preferably about 32 mm) from the ~lu;cinlal end 140 of the tube 120. The ~acl~bc,.lc wire 130 is provided with rounded end 170 to aid its mo~.".l~"lL within the tube 120 10 ~nd to allow greater pivo~ing of the assembly while reducing stress to the housing m~tl~ri~l A raAio~rr~ve core 160 is enclosed within a t~un-w lled capsule 220. This capsule 220 is inserted into tube 120 so that the distal end 230 of capsule 220 abuts the rounded end 170 of the backbone wire 130. The capsule 220 should bc flexible and the wall of capsule 220 should be m~rl--f~rnlred to a thir~n~ ss of b.,l~..e.,.l 0.001" and 0.0005". This thin capsule 220 should be 1~ made of a m~tori~! that allows the passage of n~.,huns without obtairung sigmficant r~n'io~c~ y itself. Thus, should tne c~psule material become r~n'io~ctive by neutron flux, the ~5~teriAI and any co.~ ;"A~r~ of that material should have a short half-life as coll,~A,~,d to the ~lio~ctive core 160. It is ~ipulL~ that the capsule 220 should cmit less than 10% of the r~n'i~tion emitted by core 160.
The capsule 220 may be made in a varic~y of ways. For ~ le. it may be made from a carbon fil:~rn~nt sealed with epoxy on both ends, or it may be made of a very thin metallic W O ~/4D~ PCTrUS96/08688 ~..hs~ r (e.g., ~ .;u...~ a high purit,v al~nnin--m such as ~h~ . 1100, pl~tin--m or the tit~nil~m/nickel alloy ~lesrri~ed previously) with both ends welded, soldered, or glued closed. In a preferred embodiment the iridium will be -n~ps~ ted before it is i~i~te~ to fonn lr-192 and the capsule 220 will allow the passage of n~.lL,vns to im~ t~ the core 160.
Once the capsule 220 has been posit;on~d within housing tube 120 ~ r~nt to backbone wire 130 an optional plug 250 may be inserted next to the proximal end 225 of capsule 220.
When the desired co..lponc~ have been a{~p. u~L-aL~Iy rocition~r1 the p~u~ih~lal end 140 of source wire 20 is sealed and rounded as described above. A ~.~,f~ d embodiment of the invcntion will seal p.ukh~al end 140 by fusing the proximal end oftube 120 with an arc welder (when plug 250 10 is not ~cuL~u.alcd into the source wire). Al~.~li~ly, the ~-u~ al end of source wire 20 can be sealed and rounded by welding, glumg, or soldering the plug 250 to the plU~Lhl~al end of tube I20 and ruu~l(lil g the ~lo~.al end with a router, grinder, sander, etc. to achieve a rounded end 140.
The p.~r~..cd emboclim~nt of capsule 220 will be rounded on ~oth ends. The purpose of 1~ having a rounded distal end 230 of capsule 220 is to allow grea~cr ~ivuli~ of the source wire 20 while l'dU~ lg stress to the housing ms t~ris~l at the j u-lcLu ~ of ~ f 'L ~ wire 130 and capsule 220. ~l~hl)ugh the ~.cre..cd ernho~im~nt has a single capsule 220, a plurality of c~ps~ s could be employed in the present in ~ention, or a plurality of cores 160 could be illcùu~Ola~d within a single capsule 220.
FIGURE 3 ill~ an ~ tion~l embodiment of a flexi~le source wire 30, this sourc~
wire is similar in most respects to the ernho~ shown in FIGURES 1 and 2. In this CA 02222l49 l997-ll-25 W O 9G/1~ PCTAUS96/08688 embo~lim~nt, similar clr~ in FIGURE 1 will have thc same rcf~ .nce n--rn~pl~ as their ~s~ccli~e ck~ in FIGUFUE 3. FIGUFUE 3 shows a source wire in which ~ rtive core 160 is located within an open-ended capsule ;30. This capsule 330 is like capsule 220, except that it is open on the end EJlukhl~dLe to the plu~hl~al end of the source wire 30. When open-ended capsule 330 is used, an op~ional plug 350 may be placed over the open end of capsule 330 before it is sealed. Open ended capsule 330 may be sealed by welding the proximal end of the capsule 330 to the ~lu~ al end of the tube 120, if the c2psule 330 and the tube 120 are made of the szme m~t~ l Altern2tively, if plug 350 is used then plug 35û may be co,,l,uosed of the same material as tube 120 and mav thus be welded to the ,UlU~ al end 140 of tube 120. However, ~ltem~*ve means of sealing the ylu~i~llal end of capsule 330 and tube 120 may also be employed.
Open-ended capsule 330, like capsule 220 shown in FIGURE Z, is ~uo~;l;o..~d ~,lj,.,~..l to rounded end 170 of backbone wire 130. The distal end 340 of open-ended capsule 330 is ro~mded to f~eil;t~t~ bending of source wire 30 at the juncture of b~cl~horP~ wire 130 and 1~ open-ended capsule 330.
FIGURE 7 ill~ s an ~ ; v~ embodiment of tbe source wire where the b~r l ho- ~
wire consists of a series of b~ll-like ~L~u~ S 705 i~L..or...~ ~d with short lengths of a thin wire 708. This configuratior provides ih~cle se1 fl~Yibility Ih~uu~lluul the length of the source wire with each ball acting as a pivoting agent and relieving stress to the wall of housing tube 120. FIGURE 7 also shows r~ rrive source 160 having a thin coat~Dg 712 of a neutron pe~m~ble m~t~ri~l The coa~ing 712 may be an ele.,~ul~lated coating of a m~teri~l such as gold, l, pl~tinllm, ect. Coating 712 may also be made of non-m~ot~ c matesials such as a hardening agent (e.g., glue or acrylic). Coating 712 may be applied to core 160 by l,.u:,l~g, dipping, p&inting or mo~ec~ rly bonding the coating m5?teri~l tO the out~r surface of core 160.
Coating 712 will completely cover the outside surface of core 160 and ~~ill function to prevent 5 thc flaking of the radioactive core 160.
FIGURE 4A shows a ~ d embodiment of the present invention. This embodiment of a flexible source wire 40 is similar in many respects to the embcr7im~nT~ shown in FIGURES
1 and 3. Therefore the rl~ in FIGURE 4 corresponding to similar elc ~ in FIGURES
1 and 3 are given the sasne ,ef~_.c.-ce n-~m~ ~lc as their ~y-~hve ei ~ in FIGURES I and 10 3. The embo~iim~nt illustrated in FIGURE 4A has a ~ .c.l~ corlfi~ on of its L,ac~l.ol,e wire to that sho vn in any of the other ~nbo~1im~ntc and inrlu~1es an ~lLayc~d por~on 430, a tapered portion 440, and a rounded a 450. The bacLhone wire of source uire 40 is tapered at its plu~ihllal end. Back~one wLre 420 is tapered over a~*,oxi~ ly the last 0.5" to 2.0" of its y.u~llal en~ Thc taper 440 gOGc from a 100% width of the ~ul~.~ b~r~ on.o wire 430 to about 30% to 60% of the width of the ~La~ d b~rl hon~ wire 430 as the taper exteslds toward the ~.u~ end of source w~re 40. Taper 440 of bacLbone wire 420 l~ S in a rounded asea 450, where .~ded arca 450 a$JL/lu~ ,S Ihc shape of a ball. This confi~;ulahon allows the source wire 40 to release somc of the strcs~s on the outer wall of housmg tube 120 when the source wire bends to LLa~ C a tight comer. In fact the stress placcd on rounded area 450 and 20 t~ncl~t~d to backbone wire 420 will cause the b~cl~hon~ wirc to crurnple along the tapered area as ill~ tf ~ in FIGURE 4B. However, since Ihe bacLbonf wire 420 is made from a flexiblc W O 96/40352 PCT~US96/08688 m~r~ l that exhibits little or no memory re2ention when it is bent, or more specifir~lly a m~t~l that can accept up to a 1% strain with less than a 1% ~It~tion in its original shape, the backbone wire 420 will resurne its original shape when the stress is removed and the sourcc u ire ha~ C5 a straight p~s~gç l~e novel design of backbone wire 420 increases the flrYihility and S maneuverability of the source wire 40, as well as decreasing the stress on the wall of housing ~ube 120. By dc.,.c~shlg the stress on housing tube 120, this backbone design allows the use of a smaller lI,,.."r~. source wire than is currently available.
An optional feature of each of the source wire emboflim~ntc is to attach the bacLl~nc wire 130 or 420 to the inner surface of the housing tube 120 by weldirg, fusing, soldering, lû gluing, etc. Sites of att~rhm~nt 168 are shown in FIGURES 1~. These sites of ~tt~k"~ 168 provide an inte~al safety device that insures that if the housing lube 120 were to break that the r~io~rtive core 160 would not separate from the backbone wirc 130 and could be lcLLa~L~1 from the patient. FIGURES ~ ~ through C ill~l~t~ what happens if the housing tube 120 breaks and the backbone wire 130 is not ~r~d to the inner surface of tube 120. FIGURE 513 shows 1~ where tube 120 has broken and FIGURE ~C shows how the r~ o~ctive core 160 would be left in the patient when the bAfL hol~ wire 130 was ,~ In co..l .,.~, when b~rL hon~o wire 130 is ~tt~ril~d to the i$mer surface of tube 120 at ~ r~ sites 168, as seen in FIGURE ~D, if the metal housing tube 120 brcaks at any point distal to ~tt~rhm~nt sites 168 then the radioactivc core- 160 will still be ;~ d to the bdcLho~ wire 130 and will be lelldl l~ d from the patient 20 when the ba~LI..~ wire 130 is withdrawn, as seen in FIGURE ~;E.
W O 96/40352 PCT~US96/08688 Another optional feature of the source wircs described herein is to provide a seal 178 between the inner surface of housing tube 120 and backbone wire 130 by welding, fusing, soldering, gluing, etc. the backbone wire to the interior surface of housing tube 120. This seal 178 could also scrve as an ~chm~nt site 168.
Seal 178 may be made by a number of m~tho~l~ One such method would be to thread the backbone wire 130 through the length of the housing tube. The distal end of the wire would be marked at the point where the p,uxi",al end of the wire is flush with the pLUAilllal end of the housing tube 120. ~e backbone wire would then be pushed forward and a small amount of slow drying epoxy placed around the circumference of the backbone wire 130 about two cf ~ s 10 from the proximal end of the wire. Once the epoxy is added tû the wire, the wire would be pulled back into the hûusing tube until the mark ûn the distal end e~nr~ from the distal end of the housing tube the ~lu~-;ate ~ t~n~c, preferably about 32 mm. The backbone wire would then be cut flush with the distal end of the wire and welded to the housing tube to seal the distal end ûf the backbone wire 130. Any glue ~lh~ng to the internal surface ûf the ~luxilllal portion 1~ of the housing tube, where the epoxied backbone wire was drawn through the housing tube, wûuld be reemed out before the r~iin~ctive corc 160 was inserted into t_e backbone wire.
An al~ method of producing a seal 178 would be to follow the ,uluccdu~ t scribed abûve, except to allow the epoxy tû dry before drawing the ~)lU~illlal end ûf the backboYlc wire back into the housing tube. The epoxy ring would then be ground or sanded to fit snugly within 20 the housing tube 120.
=
W O 96/40352 PCT~US~6/08688 Seal 178 would encircle backbone wire 130 closing off gap 17~ and thcreby ~JlG~ ;.Ug any "flakes" from the radioactive core 160 from migr~ring through gap 175 1G~L~ 1 the bA~-~ l.on~
- wire 130 and the inner surface of housing tube 120. Seal 178 is typically illcoll~ulaLed into ~mho~iim~ortc of the invention where radioactive core 160 is not Inrlssed in a capsule or S enr~rsul~tt~d as seen in FIGURE 1 and FIGIJRE 4C.
Seal 178 and Att~rhm~rlt site 168 are produced in a si~r.ular manner. The major difference between seal 178 and ~ttz-rhm~nt site 168 is that ~rr~rhm~rlt site 168 may only attach a small 5~ of the ~ , of b~rkho~ wire 130 to the inner su;face of the housing tube 120.
T.hus, gap 175 may not be totally closed all around the bac~bol~c wire 130 when the b~cl~h~nr wire 130 is only attArhrd to the inner surface of tube 1~0 at a small portion of its circumference as may happen in fc~ing an ~ rl"~.r.,l site.
Yet another optional feature of the source wires rl~sr~ihcd herein (but not shown) would be to coat the exterior surface of the source wire with a non-o~i~i7in~ agent, such as gold In one embodiment of the present inventiorl, a thin gold layer (from ap~lu~ ly 1 to 10 microns 1~ tl~ick) would be elc~hoplated over the outer surface of metal tube 120, or at least that portion of the surface o~ lyi~lg the r~ ~ve core 160 and preferably e ~ l~ .-1;. ,g over the ~J~U~hllal end 140 of the source wire. F~Lh.,.~U-C, the gold coating of the source wire would preferably be done prior to loading the r~rlio~rtive core 160 into ho~sing tube 120.
T.he f~hrir~ti~n of thc source wires shown in FIGURES 14 is ~esr~ibed below. The first 20 stcp in the . ~ ~A~ r~ . G of the d~Cr i~ed source wires is to obtain the metal tubing that will be used to rnake the housing tube 120. Once the tubing is acquired, a c~lihr~ted rnicrometer for PCT/U596/OY6gB
; g the outsidc ~ t- and calibrated rods for measuring the inside t1iS~m~t~r are used to validate that the tubing meets the m~n~fa~ er's specifications. The I~C~L~ed embodirnent of the present invention uses Tinel Alloy BB tubing of an extemal rliSlm~tor of 0.014 from Raychem Colporation.
The backl,onc wire is also commercially obtained. For the backbone wire 130, z solid wire of Tinel Alloy BB is ordered that has a ~l~S~rn~t~r of 0.0085". Rounded end 170 of bacL ho~
wire 130 is produced using the heat from a TIG welder~
Backbone wire 420 is made by taking the Tinel Alloy BB wire ordered and ~nriin~ it down with an electric sander The wire is held in a pin vise and rotated while ~rin~ling to taper 10 the wire. The t~p~rtng can bc done ~ ly or m~ntlst~ly The tapered end is ~,~S;~ d under a mic~usco~c and with a mic.c.lll t.. to ensure that it is ~S~pered s~tfficien~ly (i.e., with the nght degree of reduction in the ~iStm~t~r of the w~re and that it is ever~ly t pered). Once the a~ro~ L~ taper of bachL tne wire 420 is achieved then the rounded area 450 is formed on the tapered end of l~a-,hl,one wire 420. The rounded area 450 is forrned by hea~ing the tapered end of bac~nc wire 420 with an arc welder after placing the tapered end of bslrl~horl~ wire 420 into a heat sink ~ bly rnade of stlllmint-m, copper, brass, or slny other rnslteristl that tvill absorb heat away from tae ~l~tL~ object) at a p~ ..".;nrd ~ n~e above the heat si~ The riim~n~ion~ of the rounded area 450, or ball, will be d~ r~i by the gap between the top of the wire and the bottom of the 1 - .g~l~ . welding rod and by the length of ~e wire above the heat sillk 650 that is eYI-osed to the heat of the TIG welder. Typically the wire is placed 0.025~ (or about 0.1 rnm) above the heat sin~ 650 using a feeler gauge. A feeler gauge is also used to set -22~
-W O ~G/4~52 PCT~US96/08688 a gap of about 0.030" between the top of the wire and the bottom of the welding rod. Once the tapered end of backbone wire 420 is pl~ed the proper rlict~nre from the heat sink 650 and welding rod, the tapered er d of the wire 420 is exposed to a TIG welder. Thc mctal above the heat sink 650 will melt and form a rounded area 450. Typically, the rounded arca will be a ball S of about 0.0085" in rli~met~r. or of a similar ~ rn~rer as the ul~Lap~.~d backbone wire.
Next a wire of about i2 rnm in length is threaded into the lumen of the housing tube at what will become the ~.o~iu.al end 140 of the tube 120. The b~khon~ wire 130 or 420 is then threaded through the distal end of the lumen of the housing tube 120 until it reaches the 32 mrn wire placed at the proximal end of the tube 120. The backbone wire is marked where it exits 10 the distal end of the tube 120. Thc bac~bol.c wire is then cut at the mark and is rcthreaded into the lurnen of the housing tube 120 so that the cut end of back~.c w~re 130 or 4~0 is flush with the distal end of housing tube 120. The distal end of the wire is then welded to the distal end of tube 120 with a TIG welder. This provides a rounded end 150 of the source wire that has a slightly larger diarneter than tube 120 and provides an end that can be inserted into an 1~ ~fi~rlo~d~r~ where the source wire can be held in pl~e by the ~ohlldcd end 150 and a set screw that is tightf~n~d into the wire just below the rounded end 150.
Next the 32 mm wire that was pl~ed in the ~ al end of housing tube 120 is re~oved. The plo~i~al end of the housing tube 120 is then set about 0.025" above a heat sink 650. The heat sir~k 650 is also used as a c~ device to hold the wire in place. A gap of about 0.035" is set ~L~ .. n the top of the housing tube 120 and the bottom of the welding roL
Then an iridium fiber, which has been irradiated in a nuclear reactor to the desired ra~ioal l jviLy WO 96/40352 PCTrUS96/08688 and held for 1 1 to 14 days to purge the iridium fiber of any short lived rafiios~rtive CQ~.t~
is removed from its co~in~ r. The iridium fiber may or may not be ~nr~ps~ t~ as ci~srnbed above. The iridium fiber is preferably 30 mrn in length and about 0.005" in outside .li~ t. .
The radioactive iridium fiber is loaded into the housing tube 120 using a funnel. The iridium fiber is made flush with the bottom of the funnel. A small rod, having a proper length and outside ,li,.".r~ ~, is used to co--ntersink the Ir-192 about 2 mm from the top of the housing tube 120. The funnel is then removed. The assembly of the radioactive core 160 into the housing tube 120 is done using hand manipulators behind a leaded glass with lead shields so that the human assembler is not exposed to radiation The forceps, funnel and heat si~k used during the process that may have touched the radioactive core 160 must be ~rco~ ."; ~ or ~ posed of ~,o~e~ly.
Once the iridiurn fiber, or ~ ~r~ t~1 fiber, is set in the ~ ~-,al end of the housing tube 120, as ~ t~d in FIGURE 6, the exposed proxim~l end of tube 120 is subjected to the heat of a TIG welder. This fuses the ~ osed cnd of the housing tube or welds il ro plug 350, if 350 plug is present. Without the heat sink the heat would go directly to the iridiurn fiber and would oxidize, vapO~ ~ or fracture the iridiurn core 160 causing cC)~ l;r~n of the outside surface of the source wire n nri~nn~ it ''e~ However, if the housing tube is placed a ~ t~nre Y above the heat sink 650 and the ~aLG&~ core 160 is placed a distance X below the top of the heat sink 650 then the TIG weldcr will cause the tube 120 to seal the ~ al end 140 of the source wire without ~ffect;ng the r~lio~c~ve core 160. As long as the ~ t5mrcs ..~c., the top of the housing tube and the h~ ~tcink as well as the top of the housing tube and -2~
, W O 96/40352 PCTrUS~6/08688 the bottom of the welding rod are correct, a rounded surface ranging frorr. about 0.016" to about 0.018" in ~ m-~t~r results. The size of the rounded area is verified with gauges so that the reS~ in~ source wire will fit into the internal fli~m~t~r of the positioning catheter that is used to properly place the radioactive source wire at the treatrnent site. Once the source wire has becn S fabricated, it is wiped clean ~,vith s~ a~s and loaded into a lead CO~ L to await use in a patient.
Having d~crribed several emboA;m~ntc of the new and improved flexible source wire for r~n'i~tion L~caLIllLllt in acco~da"ce with the present invention, it is believed that other modifications, v~n~tit-nc and chan~es will be suggcsted to those skilled in the art in view of ~e description set forth above. It is therefor to be lmA~etood that all such v~ i~tinnC~ mon~ific~tinnc 10 and changes are believed to fall ~ ithin the scope of the invention as defined in the appended c}aims.
,
The backl,onc wire is also commercially obtained. For the backbone wire 130, z solid wire of Tinel Alloy BB is ordered that has a ~l~S~rn~t~r of 0.0085". Rounded end 170 of bacL ho~
wire 130 is produced using the heat from a TIG welder~
Backbone wire 420 is made by taking the Tinel Alloy BB wire ordered and ~nriin~ it down with an electric sander The wire is held in a pin vise and rotated while ~rin~ling to taper 10 the wire. The t~p~rtng can bc done ~ ly or m~ntlst~ly The tapered end is ~,~S;~ d under a mic~usco~c and with a mic.c.lll t.. to ensure that it is ~S~pered s~tfficien~ly (i.e., with the nght degree of reduction in the ~iStm~t~r of the w~re and that it is ever~ly t pered). Once the a~ro~ L~ taper of bachL tne wire 420 is achieved then the rounded area 450 is formed on the tapered end of l~a-,hl,one wire 420. The rounded area 450 is forrned by hea~ing the tapered end of bac~nc wire 420 with an arc welder after placing the tapered end of bslrl~horl~ wire 420 into a heat sink ~ bly rnade of stlllmint-m, copper, brass, or slny other rnslteristl that tvill absorb heat away from tae ~l~tL~ object) at a p~ ..".;nrd ~ n~e above the heat si~ The riim~n~ion~ of the rounded area 450, or ball, will be d~ r~i by the gap between the top of the wire and the bottom of the 1 - .g~l~ . welding rod and by the length of ~e wire above the heat sillk 650 that is eYI-osed to the heat of the TIG welder. Typically the wire is placed 0.025~ (or about 0.1 rnm) above the heat sin~ 650 using a feeler gauge. A feeler gauge is also used to set -22~
-W O ~G/4~52 PCT~US96/08688 a gap of about 0.030" between the top of the wire and the bottom of the welding rod. Once the tapered end of backbone wire 420 is pl~ed the proper rlict~nre from the heat sink 650 and welding rod, the tapered er d of the wire 420 is exposed to a TIG welder. Thc mctal above the heat sink 650 will melt and form a rounded area 450. Typically, the rounded arca will be a ball S of about 0.0085" in rli~met~r. or of a similar ~ rn~rer as the ul~Lap~.~d backbone wire.
Next a wire of about i2 rnm in length is threaded into the lumen of the housing tube at what will become the ~.o~iu.al end 140 of the tube 120. The b~khon~ wire 130 or 420 is then threaded through the distal end of the lumen of the housing tube 120 until it reaches the 32 mrn wire placed at the proximal end of the tube 120. The backbone wire is marked where it exits 10 the distal end of the tube 120. Thc bac~bol.c wire is then cut at the mark and is rcthreaded into the lurnen of the housing tube 120 so that the cut end of back~.c w~re 130 or 4~0 is flush with the distal end of housing tube 120. The distal end of the wire is then welded to the distal end of tube 120 with a TIG welder. This provides a rounded end 150 of the source wire that has a slightly larger diarneter than tube 120 and provides an end that can be inserted into an 1~ ~fi~rlo~d~r~ where the source wire can be held in pl~e by the ~ohlldcd end 150 and a set screw that is tightf~n~d into the wire just below the rounded end 150.
Next the 32 mm wire that was pl~ed in the ~ al end of housing tube 120 is re~oved. The plo~i~al end of the housing tube 120 is then set about 0.025" above a heat sink 650. The heat sir~k 650 is also used as a c~ device to hold the wire in place. A gap of about 0.035" is set ~L~ .. n the top of the housing tube 120 and the bottom of the welding roL
Then an iridium fiber, which has been irradiated in a nuclear reactor to the desired ra~ioal l jviLy WO 96/40352 PCTrUS96/08688 and held for 1 1 to 14 days to purge the iridium fiber of any short lived rafiios~rtive CQ~.t~
is removed from its co~in~ r. The iridium fiber may or may not be ~nr~ps~ t~ as ci~srnbed above. The iridium fiber is preferably 30 mrn in length and about 0.005" in outside .li~ t. .
The radioactive iridium fiber is loaded into the housing tube 120 using a funnel. The iridium fiber is made flush with the bottom of the funnel. A small rod, having a proper length and outside ,li,.".r~ ~, is used to co--ntersink the Ir-192 about 2 mm from the top of the housing tube 120. The funnel is then removed. The assembly of the radioactive core 160 into the housing tube 120 is done using hand manipulators behind a leaded glass with lead shields so that the human assembler is not exposed to radiation The forceps, funnel and heat si~k used during the process that may have touched the radioactive core 160 must be ~rco~ ."; ~ or ~ posed of ~,o~e~ly.
Once the iridiurn fiber, or ~ ~r~ t~1 fiber, is set in the ~ ~-,al end of the housing tube 120, as ~ t~d in FIGURE 6, the exposed proxim~l end of tube 120 is subjected to the heat of a TIG welder. This fuses the ~ osed cnd of the housing tube or welds il ro plug 350, if 350 plug is present. Without the heat sink the heat would go directly to the iridiurn fiber and would oxidize, vapO~ ~ or fracture the iridiurn core 160 causing cC)~ l;r~n of the outside surface of the source wire n nri~nn~ it ''e~ However, if the housing tube is placed a ~ t~nre Y above the heat sink 650 and the ~aLG&~ core 160 is placed a distance X below the top of the heat sink 650 then the TIG weldcr will cause the tube 120 to seal the ~ al end 140 of the source wire without ~ffect;ng the r~lio~c~ve core 160. As long as the ~ t5mrcs ..~c., the top of the housing tube and the h~ ~tcink as well as the top of the housing tube and -2~
, W O 96/40352 PCTrUS~6/08688 the bottom of the welding rod are correct, a rounded surface ranging frorr. about 0.016" to about 0.018" in ~ m-~t~r results. The size of the rounded area is verified with gauges so that the reS~ in~ source wire will fit into the internal fli~m~t~r of the positioning catheter that is used to properly place the radioactive source wire at the treatrnent site. Once the source wire has becn S fabricated, it is wiped clean ~,vith s~ a~s and loaded into a lead CO~ L to await use in a patient.
Having d~crribed several emboA;m~ntc of the new and improved flexible source wire for r~n'i~tion L~caLIllLllt in acco~da"ce with the present invention, it is believed that other modifications, v~n~tit-nc and chan~es will be suggcsted to those skilled in the art in view of ~e description set forth above. It is therefor to be lmA~etood that all such v~ i~tinnC~ mon~ific~tinnc 10 and changes are believed to fall ~ ithin the scope of the invention as defined in the appended c}aims.
,
Claims (36)
1. A source wire for radiation treatment of disease within a body comprising:
a generally cylindrical elongated housing tube having an outer surface, an interior surface, a distal end and a rounded proximal end, said tube constructed of a material that can accept up to a 1% strain with less than a 1% permanent alteration in its original configuration;
a flexible backbone wire having a first end and a second end, said wire encased and secured within said housing tube wherein said first end is adjacent to said distal end of said tube and said second end is rounded; and means for emitting radioactivity, said radioactive means localized within said housing tube adjacent to said rounded second end of said wire and proximate to said proximal end of said housing tube, wherein said proximal end is sealed to prevent the release of said radioactive core.
a generally cylindrical elongated housing tube having an outer surface, an interior surface, a distal end and a rounded proximal end, said tube constructed of a material that can accept up to a 1% strain with less than a 1% permanent alteration in its original configuration;
a flexible backbone wire having a first end and a second end, said wire encased and secured within said housing tube wherein said first end is adjacent to said distal end of said tube and said second end is rounded; and means for emitting radioactivity, said radioactive means localized within said housing tube adjacent to said rounded second end of said wire and proximate to said proximal end of said housing tube, wherein said proximal end is sealed to prevent the release of said radioactive core.
2. The source wire of claim 1, wherein said radioactive means has a smaller outer diameter than said flexible backbone.
3. The source wire of claim 1, wherein said housing tube is made of a titanium/nickel alloy.
4. The source wire of claim 3, wherein said titanium/nickel alloy is composed of about 55% nickel and about 45% titantium.
5. The source wire of claim 1, wherein an outer diameter of said housing tube is from about 0.012 in to about 0.018 in.
6. The source wire of claim 1, wherein said backbone wire is made of the same material as said housing tube.
7. The source wire of claim 1, wherein the first end of said backbone wire is attached to the distal end of said housing tube.
8. The source wire of claim 1, wherein said backbone wire is affixed to said interior surface of said housing tube at more than one site.
9. The source wire of claim 1, wherein said outer surface of said housing tube is coated with a non-oxidizing agent.
10. The source wire of claim 9, wherein said non-oxidizing agent is gold,
11. The source wire of claim 1, wherein said radioactive means can be visualized with a flurorscope.
12. The source wire of claim 1, wherein said radioactive means comprises Ir-192.
13. The source wire of claim 1, wherein said radioactive means is at least 20 mm in length.
14. The source wire of claim 1, wherein said radioactive means is encapsulated within a thin-walled neutron permeable material prior to being localized within said housing tube.
15. The source wire of claim 14, wherein said encapsulated material is gold, epoxy, carbon, titanium platium, nickel, high purity aluminum , or mixtures thereof.
16. The source wire of claim 1, further comprising a sealing device located between said backbone wire and said inner surface of said housing tube; said sealing device encircles said backbone wire to prevent radioactive material from migrating along said housing tube distal to said sealing device.
17. The source wire of claim 1, wherein said backbone wire includes an untapered portion, a tepered region, and a rounded area, said rounded area adjacent to said radioactive means.
18. The source wire of claim 17, wherein said tapered region of said backbone wire extends from about 0.5 inches to about 2.0 inches proximate to said rounded area.
19. The source wire of claim 1, wherein said backbone wire comprises a series of rounded ball-like sections interconnected by a wire having a smaller than said ball-like sections.
20. The source wire of claim 1 further comprising means for reducing stress at said proximal end of said backbone wire.
21. The source wire of claim 20 wherein said stress reducing means includes a rounded area on said second end of said backbone wire, said rounded area being adjacent to said radioactive core and attached to a tapered region of said backbone wire.
22. The source wire of claim 1, wherein said radioactive means is a single radioactive source.
23. The source wire of claim 1, wherein said radioactive means comprises a plurality of radioactive sources.
24. A source wire for radiation treatment of disease within a body comprising:
a generally cylindrical elongated housing tube having an outer surface, an interior surface, a distal end and a rounded proximal end, said tube constructed of a material that can accept up to a 1% strain with less than a 1% permanent alteration in its original configuration;
a flexible backbone wire having a first end and a second end, said wire encased and secured within said housing tube wherein said first end is adjacent to said distal end of said tube and said second end is rounded; and a capsule localized within said housing tube adjacent to said rounded second end of said wire and proximate to said proximal end of said housing tube;
means for emitting radioactivity, said radioactive means situated within said capsule; and wherein said proximal end of said housing tube is sealed to prevent the release of said radioactive core.
a generally cylindrical elongated housing tube having an outer surface, an interior surface, a distal end and a rounded proximal end, said tube constructed of a material that can accept up to a 1% strain with less than a 1% permanent alteration in its original configuration;
a flexible backbone wire having a first end and a second end, said wire encased and secured within said housing tube wherein said first end is adjacent to said distal end of said tube and said second end is rounded; and a capsule localized within said housing tube adjacent to said rounded second end of said wire and proximate to said proximal end of said housing tube;
means for emitting radioactivity, said radioactive means situated within said capsule; and wherein said proximal end of said housing tube is sealed to prevent the release of said radioactive core.
25. A source wire for radiation treatment of disease within a body comprising:
a generally cylindrical elongated housing tube having an outer surface, an interior surface, a distal end and a rounded proximal end, said tube constructed of a material that can accept up to a 1% strain with less than a 1% permanent alteration in its original configuration;
a flexible backbone wire having a first end and a second end, said wire encased and secured within said housing tube wherein said first end is adjacent to said distal end of said tube and said second end is rounded; and an encapsulated radioactive core localized within said housing tube adjacent to said rounded second end of said wire and proximate to said proximal end of said housing tube, wherein said proximal end of said housing tube is sealed to prevent the release of said radioactive core.
a generally cylindrical elongated housing tube having an outer surface, an interior surface, a distal end and a rounded proximal end, said tube constructed of a material that can accept up to a 1% strain with less than a 1% permanent alteration in its original configuration;
a flexible backbone wire having a first end and a second end, said wire encased and secured within said housing tube wherein said first end is adjacent to said distal end of said tube and said second end is rounded; and an encapsulated radioactive core localized within said housing tube adjacent to said rounded second end of said wire and proximate to said proximal end of said housing tube, wherein said proximal end of said housing tube is sealed to prevent the release of said radioactive core.
26. A source wire for radiation treatment of disease within a body comprising:
a generally cylindrical elongated housing tube having an outer surface, an interior surface, a distal end, and a rounded proximal end, said tube constructed of a nickel/titanium alloy;
a flexible backbone wire having a first end and a second end, said wire encased within said housing tube wherein said first end is attached to said distal end of said tube and said second end is rounded and adjoins a tapered area of said backbone wire, said backbone wire being affixed to said interior surface of said housing tube at one or more points; and a radioactive core localized within said housing tube adjacent to said rounded second end of said wire and proximate to said proximal end of said housing tube, wherein said radioactive core has a smaller diameter than said backbone wire; and wherein said proximal end of said housing tube is sealed to prevent the release of said radioactive core.
a generally cylindrical elongated housing tube having an outer surface, an interior surface, a distal end, and a rounded proximal end, said tube constructed of a nickel/titanium alloy;
a flexible backbone wire having a first end and a second end, said wire encased within said housing tube wherein said first end is attached to said distal end of said tube and said second end is rounded and adjoins a tapered area of said backbone wire, said backbone wire being affixed to said interior surface of said housing tube at one or more points; and a radioactive core localized within said housing tube adjacent to said rounded second end of said wire and proximate to said proximal end of said housing tube, wherein said radioactive core has a smaller diameter than said backbone wire; and wherein said proximal end of said housing tube is sealed to prevent the release of said radioactive core.
27. A process for manufacturing a radioactive source wire for irradiating diseased tissue, said process comprising the steps of:
providing a thin, flexible tube, said tube having an outer surface, an interior surface, a distal end, a proximal end, and a lumen of a predetermined diameter;
inserting a flexible backbone wire into the lumen of said distal end of said tube for a predetermined distance;
inserting a radioactive core into the lumen of said proximal end of said tube until it abuts said flexible wire; and sealing said distal end and said proximal end of said tube.
providing a thin, flexible tube, said tube having an outer surface, an interior surface, a distal end, a proximal end, and a lumen of a predetermined diameter;
inserting a flexible backbone wire into the lumen of said distal end of said tube for a predetermined distance;
inserting a radioactive core into the lumen of said proximal end of said tube until it abuts said flexible wire; and sealing said distal end and said proximal end of said tube.
28. The process of claim 27 further comprising the step of attaching said backbone wire to said interior surface of said tube at one or more points.
29. The process of claim 27 wherein said radioactive core has a smaller outer diameter than said flexible backbone.
30. The process of claim 27, wherein said tube is made of a nickel/titanium alloy.
31. The process of claim 27, wherein said tube and said backbone wire are composed of the same material.
32. The process of claim 27, further comprising the step of coating said outer surface of said source wire with a non-oxidizing agent.
33. The process of claim 27, further comprising the step of providing a seal between said backbone wire and said housing tube along a portion of said housing tube.
34. The process of claim 27, wherein said radioactive core is encapsulated in a neutron permeable material prior to being inserted into said tube.
35. A process for manufacturing a radioactive source wire for irradiating diseased tissue, said process comprising the steps of:
providing a thin, flexible tube, said tube having an outer surface, an interior surface, a distal end, a proximal end, and a lumen of a predetermined diameter;
inserting a flexible backbone wire into the lumen of said distal end of said tube for a predetermined distance;
inserting a capsule into the lumen of said proximal end of said tube until it abuts said flexible wire;
inserting a radioactive core into said capsule; and sealing said distal end and said proximal end of said tube.
providing a thin, flexible tube, said tube having an outer surface, an interior surface, a distal end, a proximal end, and a lumen of a predetermined diameter;
inserting a flexible backbone wire into the lumen of said distal end of said tube for a predetermined distance;
inserting a capsule into the lumen of said proximal end of said tube until it abuts said flexible wire;
inserting a radioactive core into said capsule; and sealing said distal end and said proximal end of said tube.
36. A process for manufacturing a radioactive source wire for irradiating diseased tissue, said process comprising the steps of:
providing a thin, flexible tube, said tube having an outer surface, an interior surface, a distal end, a proximal end, and a lumen of a predetermined diameter, said tube being made of a nickel/titanium alloy;
providing a flexible backbone wire made of a nickel/titanium alloy, said backbone wire having a first end and a second end;
tapering said first end of said backbone wire. said tapered area having a smaller end and a larger end wherein said larger end of said tapered portion adjoins an untapered portion of said backbone wire;
rounding said smaller end of said tapered area of said backbone wire;
inserting said smaller end of said tapered portion into the lumen of said distal end of said tube for a predetermined distance;
welding said second end of said backbone wire to said distal end of said tube;
attaching said backbone wire to said interior surface of said housing tube at one or more sites;
inserting a radioactive core into the lumen of said proximal end of said tube until said radioactive core abuts said flexible wire; and fusing said proximal end of said tube to prevent the release of said radioactive core.
providing a thin, flexible tube, said tube having an outer surface, an interior surface, a distal end, a proximal end, and a lumen of a predetermined diameter, said tube being made of a nickel/titanium alloy;
providing a flexible backbone wire made of a nickel/titanium alloy, said backbone wire having a first end and a second end;
tapering said first end of said backbone wire. said tapered area having a smaller end and a larger end wherein said larger end of said tapered portion adjoins an untapered portion of said backbone wire;
rounding said smaller end of said tapered area of said backbone wire;
inserting said smaller end of said tapered portion into the lumen of said distal end of said tube for a predetermined distance;
welding said second end of said backbone wire to said distal end of said tube;
attaching said backbone wire to said interior surface of said housing tube at one or more sites;
inserting a radioactive core into the lumen of said proximal end of said tube until said radioactive core abuts said flexible wire; and fusing said proximal end of said tube to prevent the release of said radioactive core.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US08/480,307 US5857956A (en) | 1994-06-08 | 1995-06-07 | Flexible source wire for localized internal irradiation of tissue |
| US08/480,307 | 1995-06-07 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2222149A1 true CA2222149A1 (en) | 1996-12-19 |
Family
ID=23907457
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002222149A Abandoned CA2222149A1 (en) | 1995-06-07 | 1996-06-07 | Flexible source wire for localized internal irradiation of tissue |
Country Status (6)
| Country | Link |
|---|---|
| US (3) | US5857956A (en) |
| EP (1) | EP0954351A4 (en) |
| JP (1) | JP2001517096A (en) |
| AU (1) | AU696822B2 (en) |
| CA (1) | CA2222149A1 (en) |
| WO (1) | WO1996040352A1 (en) |
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-
1995
- 1995-06-07 US US08/480,307 patent/US5857956A/en not_active Expired - Fee Related
-
1996
- 1996-06-07 AU AU61498/96A patent/AU696822B2/en not_active Ceased
- 1996-06-07 CA CA002222149A patent/CA2222149A1/en not_active Abandoned
- 1996-06-07 JP JP50119697A patent/JP2001517096A/en active Pending
- 1996-06-07 EP EP96919060A patent/EP0954351A4/en not_active Withdrawn
- 1996-06-07 WO PCT/US1996/008688 patent/WO1996040352A1/en not_active Application Discontinuation
-
1997
- 1997-04-11 US US08/827,785 patent/US6505392B1/en not_active Expired - Fee Related
-
1999
- 1999-12-06 US US09/455,582 patent/US6876712B1/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| EP0954351A1 (en) | 1999-11-10 |
| AU696822B2 (en) | 1998-09-17 |
| EP0954351A4 (en) | 2002-11-13 |
| US5857956A (en) | 1999-01-12 |
| US6876712B1 (en) | 2005-04-05 |
| JP2001517096A (en) | 2001-10-02 |
| AU6149896A (en) | 1996-12-30 |
| US6505392B1 (en) | 2003-01-14 |
| WO1996040352A1 (en) | 1996-12-19 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FZDE | Discontinued | ||
| FZDE | Discontinued |
Effective date: 20040607 |