CA1307987C - Catheter guide wire - Google Patents
Catheter guide wireInfo
- Publication number
- CA1307987C CA1307987C CA000596938A CA596938A CA1307987C CA 1307987 C CA1307987 C CA 1307987C CA 000596938 A CA000596938 A CA 000596938A CA 596938 A CA596938 A CA 596938A CA 1307987 C CA1307987 C CA 1307987C
- Authority
- CA
- Canada
- Prior art keywords
- wire
- catheter
- flexible
- segment
- mils
- 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.)
- Expired - Lifetime
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/09—Guide wires
- A61M2025/09175—Guide wires having specific characteristics at the distal tip
Abstract
ABSTRACT
A catheter guide wire designed for use in guiding a catheter to a target site along a tortuous vessel path. The guide wire has a relatively long, torqueable proximal wire section, a more flexible intermediate section, and a most flexible distal end section designed to be advanced across sharp-bend vessel junctions. The intermediate section has greater lubricity than the adjacent proximal and distal sections.
The greater frictional coefficient in the distal end segment acts to anchor the end of the wire in a branch vessel, when the guide wire has been advanced across the sharp-bend vessel junction, and the catheter is threaded axially over the wire, while the more lubricious surface of the intermediate section gives reduced sliding friction within the catheter during such advance. The invention also includes a catheter device containing the guide wire and catheter.
A catheter guide wire designed for use in guiding a catheter to a target site along a tortuous vessel path. The guide wire has a relatively long, torqueable proximal wire section, a more flexible intermediate section, and a most flexible distal end section designed to be advanced across sharp-bend vessel junctions. The intermediate section has greater lubricity than the adjacent proximal and distal sections.
The greater frictional coefficient in the distal end segment acts to anchor the end of the wire in a branch vessel, when the guide wire has been advanced across the sharp-bend vessel junction, and the catheter is threaded axially over the wire, while the more lubricious surface of the intermediate section gives reduced sliding friction within the catheter during such advance. The invention also includes a catheter device containing the guide wire and catheter.
Description
CAq~lETER GUIDE WIRE
1. Field of the Invention The present invention relates to a catheter guide wire for accessing a tissue target site via small-lumen tortuous path within a target tissue.
1. Field of the Invention The present invention relates to a catheter guide wire for accessing a tissue target site via small-lumen tortuous path within a target tissue.
2. Backqround of the Invention Catheters are being used increasingly as a means for delivering diagnostic or therapeutic agents to internal target sites that can be accessed through the circulatory system. For example, in angiography, catheters are designed to deliver a radio-opaque agent to a target site within a blood vessel, to allow radiographic viewing of the vessel and blood flow characteristics near the release site. For the treatment of localized disease, such as solid tumors, catheters allow a therapeutic agent to be delivered to the target site at a relatively high concentration, with minimum overall side effects. Methods for producing localized vaso-occlusion in target tissue regions, by catheter injection of a vaso-occlusive agent have also be described (co-owned U.S. patent 4,708,718 for "Hyperthermic Treatment of Tumors".
Often the target site which one wishes to access by catheter is buried within a soft tissue, such as brain or liver, and can be reached only by a tortuous route through small vessels or ducts--typically less than about 3 mm lumen diameter--in the tissue. The difficulty in ~L3~t~
a(:ce~sing such regions i9 that the ca~heter mu~;t be quit~
flexible, in order to follow the tortuous path into the ti~sue, and at the 8~me tLme, C~tiff enough to allow the di~tal end of the catheter to be manipulated from an S external access ~ite, which ~ay be a~ much as a meter or more from the tissue ~ite.
~ eretofore, two g~ne~al methods for accessing such tortuou~-path regions have been dsYi3ed. The first method ~mploys a highly flexible catheter having a dilated or dilatable di~tal e~d. A ma~or limita~ion of thi~
method i8 that the catheter will travel in the path o f highe~t blood flow rate, 80 many target ~it~s with low blood flow rate~ cannot be accepted.
In the ~econd prio~ ar~ m~thod, a torqueabla guide wire havin~ a di~tal bend i~ guided, by alternately rotating and ad~ancing the wire, to the target xite. ~ith the wire in place, a thin-walled cathet~r i~ then advanced along the wire until the distal catheter end i8 positioned at the targ~t 8ite. Once the cathe~er is ad~anced, the guide wire may be withdr~wn to allow fluid deli~ery or withdrawal through the catheter. A~ important advantage of this ~ethad i~ the abilit~ to control the location of the catheter aiong a ~ascular pa~hway.
Several type~ of guide ~ire6 for use in cathe~er placemen$ have been proposed. The simples~ type of wire i8 a pref~rred diameter o~ between about 8-40 mil~
(thou~andths of an inch). The di~al end of the wire may be proYided with a bent tip which ~an be o~iented, by ~eans of guide structure at the proximal end, to guide the wire along a ~elected va~cular path. Ideally, torque transmission should be oontrolled~ ~uch that a sslected wir~ rotation at the wire~ proximal end produc~s a cor-responding rotation of the distal end. Because of their greater flexibili~y, 8~aller diameter ~ires, a.g., having diameterS of be~ween about 8-18 mil~, may be required for . ~ \' p~d/9025-0017/ap 179~37 acces5ing ~m~ ~essel and/or to~tuoug-path regions.
~owe~er, if the wire i~ too ~hin along its entire le~gth, it may be difficult to transmit torque in a controllad manner along the entire wire length. Purther, the wire may buckle with axial mo~ement due to low colu~n ~trength.
Constant-diameter guide wires having a wire core enca~d in a flexible polymer tgbing ha~e also been propo3ed. Th~ flexible tubing acts to increase the column stren9th of the wire core without ~ignificantly reducing overall flex~bility. ~8 a re~ult, the problem of wire buckling, e~pecially ~n ~mall-diameter wires, i~ le~ened.
~iocompatibl~ polymers, 8uch as TEFLOND, polyolefin~, and polyurethane have been ~uitable.
More recen~ly, guide wir~s w~ich ha~e ~ultiple variable-thickne~8 ~teps along the wire length have been propo~ed. Hire8 of this ~ype ha~e the advantage that the proximal end region, where greater torsional ~rength i~
required, have relati~ely large diameters--e.g., be~ween about 20 40 mil5, and thQ di~tal end region, where gr~ater flex~bilitY i8 requirad, have progressively smaller diameter~. Typically, a ~ire of thi3 t~pe wîll ha~e dif-ferent diameter 8egment3 ~xtending collecti~ely over an approximately 25-60 cm distal poxtion of the wire, and short (typically 1-3 cm) tapered transition zone across each step. The tapered zone~ are typically formed by centerles~ ~rin~ing in whic~ the wire i8 placed bet~een two counter-rotating grinding wheels who~e confronting grinding surface~ are angled slightly to produce the de~ired taper oYer the width o~ the wheel If the tapered transition i~ ~elatively ~teep and/or tra~ition occurs in a regîon where a ~harp vessel bend i8 encountered, the wixe ~a~ bend h~rply in the -~tep (transition) zone, due to the differential bending modulus at the transition zone. If the catheter on the wire has ,~ 35 already been cldvanoed past the point of the bend, the p~d/9025-0017~ap ~3(~7~37 catheter may deform at the wire bend, making further cathet~r advance along the wire difficult or impo~ible.
Further, torqueability in the wire is ~educed at the region of a ~harp bend, ~ince torque ends to be transmit-ted through the angle of the b~end, rather ~han along theaxis of the wire.
Guide wires having e.~tended 8ections of continuous taper have al~o been di~clo~ed. The long tapered regions ha~e le~ tendency to undergo irrever~ible bending than relati~ely ~hort tapered wire sec~ions.
Howev2r, problems of wire buckling and di~ficulty in ~liding the wire within the catheter in a tor~uou~ path limit the ability of the wira and cathet~r to reach deep tissue site~.
Th~ problems of advancing a catheter ~long a guide ~ire in a gma~ umen tortuou~ sue pathway are al~o due to limitations in prior art catheter con~truc-tion. If the catheter is relatively rigid, it cannot trac~ over the final distal portion o~ the wire in the tortuou~ path region, because catheter advancement buckles the wire in a narrow turn, or because c~theter advancement pu115 the wire out of the distal vessel~ On ~h~ other hand, catheters haYing more flexible ~haft~r such as those u3ed in balloon flow-directed devices, lack the colu~n-2S strength in the ~atheter~3 proxLmal 3ection to be advancedover the guide wire without buckling, 3. Summarv of th~ Invention It is therefore one general objeot of the inven-tion to provide a guide wire d2~igned to overcome theabove-di8cus9ed lLmitations in accessing th~ tortuous path tissue site~.
A more specific ob~ect of the invention is to pro~ide such a guide wire for accessing soft tissue target ,~
pjd/9025-0017fap ~L3~ 37 ~its~, ~uch a5 deep brain ~ites, which have heretofore been inacce~Yible to catheters.
Still another ob~ec~ o~ the in~en~ion i~ to provide a catheter device for delivery of an injectable fluid or particle su~pen~ion at a tissue ~ite which can be accessed only by a tortuous ve~3sel path, which may be defined by arterie5, veins ~ or tiYsue ducts.
The in~ention includes r in one a~pect, a guide wire de~igned ~or use in guiding a catheter to a target ~ite along a tortuous ve~sel path which i5 ~t least about 20 cm long and which has ~harp-~end ~e~el ~unctions.
Such a path rQquires advancing a distal portion of the wire acro~ the ~unction, then ~liding the catheter over the ad~anced portion of the ~ire. Th~ wire ha~ three 1~ sec~ion~ with progressi~ely greater ~lexibilit~, and diff~rent lubricity or ~liding proper~ies. A ~lexible, torqueable prox~mal wire ~ection is be~ween ~bout 50-2S0 cm in length and iY foxmed of a proximal ~ire core segment haYin~ an outer di~meter of be~ween abou~ 10-40 mils. A
~ore flexible inter~diate ~ec~ion has a length between about 20-60 cm and i8 formed from an ~n~ermediate wire-core ~egment ~aYing a red~ced dlame~er of b~tween abou~ 4 20 mil~ a~d be~ween a~out 10%-S0~ of ~h~ core'~ proximal ~egment, and a flexible tube co~ering ~hich encases the intermed~ate ~ore g~gm~nt. A most flexible di~tal end ~ction ha3 ~ length between about 1-10 cm and i5 formed from a distal wire core segment h~ving a reduced diameter of between about 2-6 mil~, and a ~lexible sleeve covering the di~tal end ~egment and providing ~olumn s~rength thereto. The intermediate ~ection ha~ a low-friction polymer ~urface provided b~ the covering which makes the ~ection more lubricious than the ad~acent distal ~nd segment.
In a preferred embodiment, the proximal wire i 35 core ~egment i5 between about 10-20 mils, the inte~medi-pjd/9025-0017/ap ~3~7gZ37 a~e wire core segment has an average diame~er of between about 4-8 mil8, and the distal wire core ~egment has a diameter of between about 2-5 mils. The intermediate wire core ~egment has a sub~tantially con~tant diameter along its length, and includ~s a rela~ively ~hort region of taper bstw~en the constant-diametar portion~ of the di~tal and intermediate wire core segment. The di~al wire core segment ha~ a 8ub5tantially continuous taper along it~
length. Pre~erably the guide wire ha~ a ~ub~tantially constant outer diameter alony it~ length.
A180 in a pre~erred embodimen~, ~he flexib1e polymer covering in the intermediate ~ection is a polymer tube which i8 effecti~e to increase the col~mn strength of the intermediate section, and which ha~ a low-fri~tion polymer coating. The slee~e CoYering i~ a helical ~oil formed from a radio-opaque me~al s~rand material.
In another aspect, ~he in~ent~on includes a ~atheter device for u~e in accessing a ~arg~t ~ite alon~ a tortuous ve89el path. ~he device Lncludes a guide wire of the type de~cribed above and a cathe~er designed ~o be ad~an~ed ove~ the wire, ~ith ~uch advan~ed to the target site.
In a preferred ~mbediment, the cathe~er has a relatively 8tiff proxLmal t~be ~egment dimensioned to track the wire along it proxLmal end 3ec~ion, and a relatively flexi~le distal tube ~e~ment constructed and dimen~ioned to track the ~re a1Ong it~ intermediate and distal end ~e~tio~s~ Al~o in a preferred embodiment, the ca~heter has a ~Ubstantially constan~-diame~er inner lumen, the wire has a substantially con5tant diameter along itC length, and cLearance between the wire and the inner catheter lumen of about 2-S mils.
These and other objec~s and features of the invention will become more fully appreciated when the ol-pjd/9025-0017/ap ~L3~7~87 lowing detailed description o~ the in~ention is read in conjun~tion with the accompanying drawings.
Brief De~cript_ n o~ the__rawin~
Figure 1 shows fragmentary portions of a guide wire constructed according to one embodiment of the present invention;
Figure 2 shows ~ragmentary portion~ of a guide wire constructe~ accord~ng to anoth~r embodim~nt of th~
invention;
~ igures 3 and 4 are e~larg~d si~e views of ~
discrete (Figure 3) and continuous (Figura 4~ taper in the tapered region of an embodiment of the guide wir~ Yuch a~
shown in Pigure l;
Figures 5 and 6 are anlarged sec~ional views of diff~rent embodim~nts of flexible ~lee~e~ ~uitable for covering the distal end regions of the ~uide wir~
constructed ac~ording to the in~en~ion;
Pigure 7 show~ a eatheter device construc~ed according to the pre8ent ln~entlon;
Figure 8 ~how~ an enlarged ~ection o ~he cath~ter device i~ Figure 7, taken alon~ ~he region 2~ indicated ~t 8-8;
~ igure 9 illu~kra~e~ a por~ion o~ a tortuou~
path in a ~oft ti88Ue~ and a ca~heter and guide ~ire being advanced along this pa~h;
Fi~ur~s 10 and 11 are enlarged regions o~ the Figure 11 path, 8howing the s~eps in ad~ancing the catheter through a sharp-bend ~unction in the path.
p~d/902~-0017/ap IL3~g~7 Detailed Description ~t ~h- InventinA
I. Guide Wire Figure 1 shows a guide wire 20 cons~ructed ac-cording to one embodlment of the in~en~ion. The wire i~ aflexible torqueable wire ha~ing an overall length of be~ween a~out 70-300 cm ~tween its praximal and di~tal ends 22, 24 J re~pectlvely, and a maximum outer diameter of between about 8-40 mils (thousandths of an inch). The ma~or portion of the wire is a flexible proxLmal ~ection 26 who9e overall length range~ from about 40-250 cm. This section is followed by a more flexi~le intermediate 3ec-tion 28 having a len~th between about 15-60 ~il~, ~nd a mo~t flexible distal end ~ection 30 who~e length i8 betwe~n about 1-10 cm. It will be apprec ~ated that the wir~ i~ hown in greatly exaggerated radial s~ale, and that 8 ma~or portion of the distal end ~ection has been cut away.
A wire core 32 in th~ yuide wire is ~ormed o a 20 flexiblç!, torqueable wire filam~n~ material, such as ~tainles~ . teel. The diameter of the wire core, at it~
maximum, i~ between about 8-40 mil~. The 3egmen~ of ~he core forming the prox~mal ~ec~ion o~ the guide wire, indicated ~t 34, h~ a sub~tantiall~ uniform diameter 25 along it5 lengl:h, and corre~ponds to the maximlam diameter of the core, i-~-, between 8-40 mils.
Within the intermed~ a~e section of the wire, the core i~ tapered from the proximal-~;ection diameter down to a reduced diameter which i~ pre~erably about 4-20 mils and 30 between about 10%-50% of the core ~ 5 proximal esegm~nt diameter . Thus, for example r where the proximal section core diameteL i3 18 mils, the core tapers tc~ a minimum of between about 2~9 mils.
In the embodiment 3howr~ in Figure 1 r the taper in the core occurs o~er a relatively short tapered segment p~d/9025-0017/ap ~L3~ 7 36 which iR followed by a reduced-diame~er 3e~ment 38 hav-ing a ~u}~stantially con~tant s~iameter along it~ leng~h.
The length of the tapered segIInent is ~ypically between a~out 10%-50% that o~ th~ con~itan~-diameter, and the two 5 ~egment~ togeth~r make up the leng~h of the intermediate wire section, i-e-, about 20-60 c~o.
The tapered ~egm~nt in the Pigure 1 wire e~odiment iB Jhowll Ln enlarg6!d sti~w in FigurQ 3. Thi~
t~pe of taper may be thought of as a di~crete taper, in 10 that the profile c~f the taper~d qecltion wflll i8 linearl and th~ segmen~: inter9eC:t3 the opposed coII~tant-dlameter segment~ at discrete angle~ at l:he an~ular :cegion~ 40a, 40b in the fig~- Figure 4 shnws a ~capered s~gment 42 o~
a wire core 44 formed ln accordance ~ith emother 15 ~odiment of the in~rerltion. }Iere~ the ~lope of the taper i8 c9ntinuouslY ~a~in~3, ~d the ~egm~nt ha~ the gellerally s-3haped wa~l profil~ 88en. ~he 'capE~r ~segment illu3trated ~n ~gure 4 ~8 generally preferred Yince it ~inimize~
bending and tor~ue-t an~ai~3ion dif~ll3x~ntials at ~nd~ of 20 the tape~ d 3~agme~ l~ethods of fonning ~he t~o typ~8 o:
tapers will be d~cu~sed bs~low.
The twn segmen~ ~akinçl ~p the core of the intermediate se~:tion o~ sire ar~ covered along their lerlgth by a flexible polymer covering ~6. The i1~a~0r func-25 tion of the coY~ring i8 to pro~ridE~ a, ll.abricaous ( low-friction) 8llrfa~:e along the i~tesm~çlia~e ~ection, arld more p2~:icul~rly, a ~urface ~hich i.~ Dlore lulsricious than th~
surface of the ad~acent; distal ~e~gment of the wire and o~
the wirE3 core- The covering prefera~ly also func~ion~ lto 30 prostid6~ c~l~amn 8UppO~: ~:0 the reduced-diameter corE~ ~n the intenned~ ake g3QCtion, to r~duc~ the tendency of ~hi~ ~ec-tion to buckl~ under axial c:ompre~ion .
Co~v~ring 46 i8 preferably ~ormed of a polymer, 3uch a~ TEELON~, polyole~in, or polyurethane which can be 35 bonded or oth~ e tightly a~ixed ~o the core wire, and pjd~902~-0017/ap -- .... ~ ~ .
~3~7'~7 which itself ha9 a low-frlction ~urface, as i8 the ca~e for TEFLON~, or who~e surface can be coa~ed with a low-friction ~urface. Other ~uitahle coveringC include a tube formed from ~irtually a~y pol~ner having exposed S hydrogen~, such as polyester~ polyolefins, polycarbonate, poly~inylchloride, latPx or silicon rubber, poly~tyrene, and polyacrylic~, and a ~urface coa~ing formed of a highly hydrophilic, low-friction poly~ler, such as poly~inylpyrrolidone (PVP), polyethy~eneoxide, or polyhydroxyethylmethacryla~e (polyHEMA) or copolymers thereof.
In the embodiment ~hown in ~igure 1, covexing 46 is ~ormed of a relatively thick-walled tubing 48 a~d a ~urface coating 50 of a low-friction pol~mer. The inner diameter of the tubing is such a~ ~o form a tight fit o~
the tubing on the wire cor~, and the outer diametar is substantially the ~ame as ~hat o~ the core wi~e proxLmal ~ection. Thus the proximal and intermedi~P wire sections have ~ub~tantially the same outer diæmeters, e.g., between about 8-40 mil~- The ~egm~n~ o~ the tubin~ encasing tapered sectio~ 36 preferably has a complementary taper, as ~een be~t in Figure 3.
The low-~ric~ion polymer coa~ing may al~o co~er an ad~acent portion of the wire'~ proximal ~ec~ion, a~
~hown in ~igure 1- Typically, ~he coating will be ~pplied to the 20 50 cm of the di~tal ~ction core adjacent the intermediate ~ectio~- AltQrnati~ely, the proximal section core may be coated with a le88 lubriciou~ protecti~e coat-ing material, ~uch a8 silicone coating or the like.
With continued r~erence ~o ~igure 1, di~tal ~ection 30 of the wire ha~ a length between abo~t 1-10 cm and preferably has still grea~ex flexibility than the intermediate wire 8ection. The w~re core in the distal ~ection, referred to a8 8~ment 54, has a diameter which i8 ~ubstantially no great~r than that o~ the intermediate p~d/9025-0017/ap ~3~ 37 section cor~, and preferably is tapered to a reduced diameter of between about 2-6 mils. In ~hs embodLment ~hown in Figure 1, the core has a linear t~per over its entire length- Alternatiy~ly~ the core may contain one or more di~crete tapers.
The di5tal ~ection portion of ~he core is ~ully or partially encased in a fle~cible 81eeve. The sleeve 3hown in Figure 1 i5 a ~oft, ile~i~le helical coil 56 which i~ formed Conventionhlly~ e.g., as a winding of radio-opaque wire ~trand, ~uch as platinum, gold, or tung~ten ~trand- As ~hown, the coil extend3 from covering 46 to the di8tal end of thQ wire core. The coil prefer-ably ha5 a fixed-dimen~ion inner diameter, as shown, or may be tapered, e.g., to match the ~aper in th~ core. At-tachment of the coil t~ the core i~ preferably by two orthres 801der o~ weld ~oints, including a proxLmal ~oint 60 and a round~d di~tal ~oint 62. An intermedia~e ~oint ~not shown) ~erve~ to tran~mit torque in ~he wire to the coil, to cau~e the end region o~ the guide wir~ to ~end slightly at thi~ golder ~oin~t to allow ~he wire to ~e guided in a ~elected direction in a ve~sel nQ~work, by torgueing the proximal end of the wire. The c:ore and ::oil call be ir-rever ibly ~haped, prior to u~e, to includle w~re bend use-ful in guiding the wire.
In addition to providlng a mechani~3m for wire bending near the wire tip, ~he coil also gives th~ distal R~ction of the wire in~:reased ~:olumn ~treE~gth ( in the axial dir~c~ion), and reduces the chance of bucXling in thiY ectiorl with axial compression~ At the ~me 'cime, the com~ined flexibi.~ity of the reduced diam~ter core and the coil are compatible with a sesie~ of ~harp bends, as ~he wire is mo~ed through a tortuous pa~hway in the target tissue. The rounded ioint at the end of the wire act~ to shield vessel walls from the sharp end of the wire core.
i 3S
p~d/9025-0017/ap ~l3~87 According to an ~portant f~akur~ of the inven-tion, the distal 8etion of the wire, including the ~leeve encasing the wire core in this ~ection, i8 l~s lubri-ciou~, i.e., has a higher ~ric:tional coefficient, than that of the ad;acant intermedi.a~e section. The higher-friction ~urface in this secti.on functions ~pecifically, during a catheter placement operation, to help anchor the di~tal -qection again3t a ve~8el wall at a va~el ~unction, a~ will be 9een below. The hi.gher ~riction can be achieved in a number of way~. Where the ~lee~e is a coil, the coiled 9urface inherently h~ a higher ~urface co-efficient than a low-~riction pol~mer coa~ing.
Figure 5 i8 an ~nlarged gectional Yiew of a di~tal 8ection of a wire ~uch as ~hown in Fiyure 1. The ~5 coil in the 8ection, here indicated at S4, i3 formed as a helical winding of a radioopaque ~rand 66 which ha~ been precoated by a polymer cover 67. ~h~ polymer can be selected for lo~- or high-~riction surface propertie , to ~electi~ely vary the frictional pxoper~ies of the ~leev~.
2~ Alternati~ely. a coil form~d from a bare strand ~ay be coated, after attachment to the wire core, with a ~uitable protect~e polymer, such as ~ilicon or the like.
In another ~mbodiment, tho ~leeve in the diYtal ~egment may be a polymer tubing which i8 both fl~xible and capable of providing colu~n str~ngth to ~he distal-section wire core. The tubing, if formed t~ ha~e a smooth ~all~
can be made from a ~ariety of polymers, ~u~h ~s poly-ethylene, latex or the lik~, which have relativel~ high frictional coefficients. Alterna~ivaly, ~he sleeve may be formed with ~urface feature~ which increase ~he frictional coefficient 8ub8tantially. One such sleeve i~ ~hown in enlarged vie~ in Fi~ure 6, showing a por~ion of a di~tal section 8imilar ~o Pigure 5. Here the distal ~egment of the wire cor~, indicated at 70, i3 ~ncas~d in a polymer tube 72 havirlg a series of annular groove~, ~uch as ., p~d/9025-0017/ap ~L3(~79~7 qrooves 74 form~d in it~ surfacQ. It can be ~pprsciated that the~e grooYe~ pro~ridl3 incraelgE2d t~ ~lexibili~y a~
well 218 greelt~r frictional co~f~ ien~ at thla ~ame time, th~ added column ~trength corltributed by ~h~ tube i8 5 ~ub . tantiall~ pre~e~d sinc~ axial c~pre~ion on th tu}: e a~-t~ to preB8 th~ greo~ed rE~g~o~ a~in~ one ~nothor. The polymer ~le~re i8 pr~afQr~Lbly pro~ided wlth .
radio-~paqua band ( no~ ~hown ] .
Pi ~e 2 ~hc~ guid~ 80 corl~truct~d ao-10 cording to a ~concl ~s~neral ~bodl~t of th~ ~ nvention .The ~ire haB prox~l, :Lnt0rm~cuatt~ d di~t~ ctions 82, 84, B6, ~p~cti~lBly, uad ~ eo~e ~ith corrE~Ypond-ing cor6~ JQg~9~ltJ 38 ~ 90, 92, ~eJpec~ . The wl~ di for~ fr~ th~lt ~ho~ tho ~ cor~ has 15 a cont$nuou~ ~ (or, ~ ti~ly, ~ s:ont~uou~ S-shaped CllrYe ) through tha l~t~ ~d di3~al ~tions ~th~r ~ hoa~ r ~E~d ~ nd a lorlgex r~duc~d~a~t8r llQ9~nt. Th~ o~ o~
including ~ pol~er 8u~:f~:o co~ 4 e9h~ch p~r~d~
low-friction ol~fae~ s th~ t~ ~osXlo~a and an ad~c~ o~ of t:he d~al J~o~a, ~ 8t~b~tantially ~d~nt$cal to tho~ r~6~ r~ferQns::~ to ~igur0 1.
~n for~ing th~ g~ o~ ~ao L~r~ntionq t:h~
cors $~ lly C~
comr~ntional, S~lut~lt~ r çp.l~ ~ ch ~ i~
com~ a~ 98~ W~10. SteEI
grinding ~n b~ u~ed to fosm r~ t~ y ~hort tap~ræl ~eç~nt~, ~uch æ~ in fo~g ~h~ cog~ Pigax~
30 ~e. ~ hod~ Of i~os~in~ ral~ lon~, eollti~uou~ly tap~r~d c05:~ (Pigur~ 2) ~n~ non l.inelar t~pgtrecl r3gions ( Figur~ J~ ) h~ve ~1l d~cr~bQci in eo~me~d PC~ p~tent applic~t~on for ~Catheter ancl ~1~8ue~ sing M~thod", ~7~87/07493, file~d D~c~ ar 17 ~ 7.
~ e .~ J
p~dl9025-0017/ap ~3~3~7 The f lexible polymer ~ube c~vering the inter-mediate cor~ is 8egment ( s ) can be applied t~ ths core by conventional pol~mer spraying or dipping methods, or b~
a~taching a preformed polymer tube ~o the core ~egment ( 8 ) .
5 The latter can be accompli3hecl by attaching the tub~ to the coxe under heat ~hrinking condition~3, or by securing ~he tube to the wire by a suit:able wire/polymer bonding agent . A6 indicated above, the lubriciou~ ~urf ace coating may be formed by the ~urface of ~he covering, or prefer-10 ably, by applyins a lubricious pol~er surace coating.Such a surface coating, which preferably c:ovl3r~ a portion of the distal section, can be applied by spraying or dipping, according to known method~.
15 II. Catheter Device Figure 7 ~hows a c:athe~er device 100 constructed according to one aspect of ~he inven~ion. The de~ e include~ a catheter 102 which will b~ descxibed below, and a gui~e wire ~ h~3re indicated at 104 t of ~he type de~cribed 20 abr~ve. The de~rice i~ d~3~igned for acc:esRing a target ~i~e which can be r0ached only along a small lumen tor~uous path ~ithin a target tis~ue, a~ will be described with reference to Figure~ 9-11 below.
With reference to Pigure 7, ~::a~heter 102 i5 ~ormed of a flexi}:)le tube 110 which i~ dimen~ioned to reCQi~e the guide wire therethrough, a~ shown. In a prefsrred embodim2nt of the invention, the catheter has a relatively 8tiff pro~Lmal segment 116 which ~ake~ up between abo~ 70%-95~ of the total tube length, and a relati~elY flexible diBtal segmen~ 118 which makes up the remaining approxlmately S%-30% of the tube length. The construction of a catheter of this type haR been detailed in above-melltiOned PCT patent application for l~Ca~heter and Ti~sue i~cceBsing Methodl~. Briefly, and with xeference to Figure 8, the relatively stiff ~ec~ion of the tube i~
" ~
pjd/9025-OU17/ap ~3~7~
composed of inner and outer coaxial tubes 120, 122 which are tight-fitting with respect to each other. The ~tiff-ness in the proximal ~egment i.~ provided predominantly by tub~ 120. The in~er~ ~tiffer tube i~ preferably S polypropylene or high-den~i~y polyethylene tubing ha~ing a final wall thic~ness (in the a~sQ~led cathe~er) of be~ween about 2-4 mils. The outer, more flexibls tube i8 preferably low-den~ity polyethlylene or ~ilicone tubing, also h~ving a preferred wall thickne~s o~ between about 2-4 mil3.
Wlth continued referen~ to Figure 8, the innerdiameter of the proximal segmant is d~men~ioned, with respect to the guide wire, to pro~ide ~uf icie~t wire clearance to all9w the catheter to ~e ~oved ea~ily o~r the wire in an axial direction, during cathe~er placemen~
~t the target ~ite. The guide wire its~lf mu~ have a relatively 9mall diameter, to penmit ~t~ guided movement along a tortuous path ~n a target ti~ue, In a preferred embodiment of the in~ention, the inner diame~er of the catheter and the outer diameter of the guide wire are sub~tantially conBtant along their length~, and the clear-ance between the two ~s between about 2-5 mil~. Thu~ r for exampl~, a catheter de~igned ~or u~ wi~h constant-diameter guide wire ~ho~e outer di~met~r i~ 18 ~il8 ha~ a Z5 preferred inner dia~eter of 20-25 mil~, and more prefer-ably 21-22 mils- The pr~f~rred cl~arance betwe~n the wire and ~nner wall of the ~egment reduces the ~endency of the ~egment to buckle under compre~sional ~rain, since the wire prcvides col~mn ~upport against tube bending and crimping.
The optLmal length of the proximal segment will vary ac~ordi~g to the di~tance between the ti8sue region which i~ to be accessed by the ca~hete~ and the external , ~ body ~ite at which the catheter is introduced. In a preferred embodiment, the total length of tha catheter p~d/~025-0017/ap ~3~73~37 distal ~ection is about the sam~ length a~ that of the intermediate and distal wire ~ections combined~
Completing ~he de~cription of the c~theter, and with r~ference to Figure 7, the free end of the proximal segment is attached to a fitting 124, such as a standard syringe fittin~, for u~e ~n connecting a ~yrin~e to the cathet~r ~or f luid in j ection and withdrawal. At the distal end of the cath~ter~ a radio-opaque band 125 (Figure 9), such as a gold or platinum band, serve~ as a marker for following the position of the ~a~h~er radiographically.
III. O~eration The method of inser~ing the catheter ~nto a ti~sue region which is rea~hed ~y a tortuous path will be described now with reference ~o Figure 9~ The fiyure ~hows a region o~ oft ti83ue 1~0, such as brain tissue, containing a target site 142. Ini~ially the ~ide wire, indic~t~d at 104, i~ ~ed ~ro~ a vaficular acce~ region ad~acent the target tiRsue i~to a ti~ue-~upply ~es~el 144 which ~xtends into the ti~su~. In the pr~ nt ~xample, the tortUoU9 path to the targe~ e ~nvolves ~es el 144, a ve~5el 146 which bra~ches off ~es~el 144 at more than right angle, and branch ~e~el~ 14B and 150 which each branch off the preceding ~essel as ~hown. The path ~hown involve~ (a) a numb~r o~ bends, s~me of which may be 90 degrees or more, ~b) 8mall ~Qs~ls, typically with lumen diameters of les~ than about 3 mm, and ~c) a total path length ~ithin th~ target tis~ue of at least A~out 10-20 c~
In operation, the cath~tQr device i~ threaded as a unit from an external access site ~hrough the ~a~culature tc~ a region ad;acen~, but not intu ~he tortuous path region of the target tissue. This is done, in the usual c:a~e where the catheter must pa~s through the pjd/9025-0017/ap 13~;7~7 cardiac aorta, by first placing a relatively laxge diameter guiding catheter ~e.y., about 40 mils inner diameter) $rom the acce~ sit~ through the aorta and toward the target ~ite. ~he pre~ent catheter device is S then threaded through the guiding ~atheter pa~t ~he aorta, where large ve~sel di~m~ters and high blood ~low volumes make it difficult to control the movemen~ and position o~
the catheter. Once beyond the guiding catheter, the catheter device can b~ advanced as a unit toward the target site~ In genera1, ~he path from the acce~s site to the region ad~acent the ti3sue i~ ea~ily acce~sibler in that ~harp bends, 8ma~ u~en vesse~ nd/or ~oft tis~ue ~tructure are not encountered~
Typically, when the tortuou~ pa~h tis~ue region 15 i~ reached, and particularly where ~harp bends in the path are æncountered, the wire iæ advanced ahead of the catheter. Thi~ i~ done ~y advancing the wire axially within the catheter and at the ~ame ~im~ torqueing the wira to orient the bent tip o~ the wire in ~he direction of desired wire ~o~ement. Af~er the wire has been 50 ad~anced, the catheter i~ then advaneed o~er the wire until the catheter end i clo~e to th~ wire ~nd. Thi~
procedure i~ repeated until the wire and catheter have been fully ad~anced through the 8mall-dlameter ti~sue vessel region to the taryet ti~sue ~ite.
The features o~ the presen~ in~ention which c~ntribute to it5 ability to reach targe~ ~ites along tortuou~, ~oft-tis~ue path~ can be appr~ciated from ~igure~ 10 and 11, whiGh ~h~w an enlarged p~rtion of the region 140 illdicated at dash-dot line 151 in Figure 9.
Figure 10 ~how~ ~he con~iguration o the catheter just after the di~;tal ~ection of the guide wirer indicated at 152, has been advanced ahead of the cathe~er into bran~h vessel 148 fl-om ~essel 146~ The wire advance i~ achieved by fir-~t tor~Iuing the wire to orient the wire bend toward pjd/9025-0017/ap 31~7~7 Y~ssel 148, then moving the wire a~ially until the wire end move~ into the branch ve~sQl.
Wi~h the wire now hE~ld in it~3 advancsd position, the cath~ter ig moved axially over the wire, in the 5 direction of the ~es~el branch~, It can b~ appr2c:iated fsom ~igure 10 that molrement of th~ catheter ov6!~ th~ wire bend ~ndica$ed at 1~6 cai~se3 this region of thE3 ~ir~ to straighten, with the e~fi3ct of increasing the force of 'che catheter di~tal ~ection agains1- t:he ~ide of ~e~sel 148.
10 If the frictional force l~etween th~a wi:re ~nd region and the ~re~3sel i~ ~uite low, ~che ~nd rç~gion o~ l:he ~rir~ ~ithin vessel 148 will now tend to ~lip out o~ the ~ 1, since the wir~ in thi~ region i~ ~ery fl~ and ~asily capable of fo~nçl the type~ o~ ro~ g loop rleeded to 1~ excricats it8elf from ~88el 1~. E'G~ l:hi8 rea~orl, it i8 important that the 8u:rfEIce of ~che d.~.~tal ~gion of the wire be 2~ relatiY~ly high-fric~ior~ Ear:e.
It i~ al30 ~een in P~gurs 10 that th~
interm~diate 8~ 0n of th~3 wir~ 3re indicatE~d at 160, 20 i8 containi3d larg~ly within ~hQ c:athe~er a~ the distal ~ect~on of the wire i8 ac~cad throug~ thç~ 3el ~:canch ~unction. ~at 4ach b~nd in t~ thetE~x, the wire il!3 pre~i~ed again he ad~acen~ wall ~sRction of the catheter, as ~h~wn at ~end 162. ~his ~ressur~, it can b~ ~e*n, lncr2ase3 the ~sictional resistanc~ oun~ered in ~o~in~
the wire axi~lly ~ith~n th~ ca~heter~ In par~icular, it h~s been found with prior art wir~s ~ha~ two or ~ore ~uch ~iharp bend~ in ~he cathet~r can ~ake it ~mpo3~ible ~ither to advance the guide wira rela~iv~ ~o ~hQ ~atheter~ during cath~t~r plac~ment, or ~o ~emo~e th~ wire af~er placement.
Ac~ord~ng ~o an important feature o~ the inven~ion, ~his problem i~ ~ol~ed ~ub~tantially by th~ low-~riction gurface on the intermedia~e wire Rection.
To illu5trate, as the cath~ter in Fi~ure 10 i~
ad~anc~d o~ the distal ~i~c~ion of the wire t~ ~he pjdt9025-0017/ap ~ 3~79B7 position shown in Figure 11~ only the most diYtal bend will inYol~e a hisher-friction portion of the wire, although the low-riction intexmediat~ ~ection may ~n~age the catheter at 8everal bends. Even along khe di~tal wire section, the force needed to o~ercome the fr ctional re~istance between the wire and di~al catha~r 3ection i8 reduced by high flexi~ility of this segmen~. Similarly, the relatively high ~lexibility of the wire'~ interm~diate ~action cooperates with the low-friction -~ur~ace to facilitate axial movement of the wire in the catheter in a tortuous path.
Summarizing the Lmportant features of th~
invention, the greater flexlbility ~n the distal and intermediate 3ections of ~ha guide Wir3, r~lated to th~
reduced-diameter feature of the wire core, allows the wire to be guided along a tQrtuous 3mall-ve~s~l path in a ~oft tissue, for acce~ing deep-ti~u~ ~ites. The high flexibility in the8e 3ections al~o reduce~ frictional forc~ ~et up between the wire and catheter ~n bend regions along the acce~ path.
~ hD relati~ely high friction -~urface of the di3tal 3ection i8 required in anchoring the di~tal section of the ~ire within a branch ~es~l, aæ the ca~heter is ad~anced acros~ the ~unc~ion. By contra~, the low-2~ friction ~urface of the intermedia~e -~ection acks to minimize th~ frictional resi~tance to axial wire moYement through the cathet2r at regions o~ sharp be~ding in the catheter. Thi8 a11Ows the wire ~o slide ~and ro~a~ed~
within the catheter with gr~a~er ea~e and reduces the liklihood that the wire will become ~mobilized within the cathQter during a placemen~ operation.
In a preferred embodimen~ of the in~ention, a portion of th~ proxLmal wire section ad~acent the intermediate S~ction is also provided with a low-friction ,., i ` 35 ~urface, i.e-, ~ubs~antially lower than that of the wire p~d/9025-0017/ap 13~7~7 core, to further reduce frictional resis~ance to wire movement. The more proximal portion of this ~ection which will ~e handled by the user in guidi~g th~ wire from a body-access site to the target site pre~erably has a highsr friction surface, to al:Low the wire to be manipulated without 31ippag~.
Also in a preferred embodiment, the low-friction covering in the intermediat~ ~ection i~ fo~med of a flexible tube which gives col~n ~upport to the wire core.
10 The greater column ~trength allows higher axial force to be applied to the wire in a catheter placement operation, without wire buckling. Where ~he guide wire and catheter esch have constant diameters along ~heir length~, and a clearance of 2-5 ~il~ between the two~ ~he catheter al~o serve~ to r~ t wir~ bu~ling.
Additional ad~antages, in term~ of ~arget-site acces~ibility, are gained when ~ha guid~ wirs i~ used with the gradient-~lexibility catheter d~cribed above. The greater flexibility in th~ d~3~al region of ~he catheter allows the cathet~r to follow or tracX a wire bend wi~h le~ axial ~orce, ~inca cathe~er defonmation i~ redu~d.
Further, becau8e the catheter Qnd region fl~xes more easily, it exert~ less force on the distal section of the wire when bein~ ad~anced through a branch ves~el ~unction, RO the wir~ 8tays anchored in ~he branch vessel with les~
frictional re~i~tance betw~Rn the wire and ~essel wall.
Preliminary clinical ~ud~g with the pre~ent invention indirate that the guide wire/catheter ean be guided to deep brain 3ites which have been inacce~si~le previou~ly- The8e 8ites typically i~volve catheter guidance along a 15-25 cm brain ves~el pathway which ha~ 2 to 6 ve~s5el ~unctions where ~harp ~urn5 are encountered, and spacing between ad~acent turns of between about 1 to 5 `~`I"` cm.
pjd/9025-0017/ap 13~P7~3~7 While the in~ention ~las been described with respect to particular em~odiments and u~es, it will be appreciated tha$ variou~ changes and ~odificationS can be made without dep~rting from ~he scope of ~he invention~
S
1~
p~d/9025-0017~ap
Often the target site which one wishes to access by catheter is buried within a soft tissue, such as brain or liver, and can be reached only by a tortuous route through small vessels or ducts--typically less than about 3 mm lumen diameter--in the tissue. The difficulty in ~L3~t~
a(:ce~sing such regions i9 that the ca~heter mu~;t be quit~
flexible, in order to follow the tortuous path into the ti~sue, and at the 8~me tLme, C~tiff enough to allow the di~tal end of the catheter to be manipulated from an S external access ~ite, which ~ay be a~ much as a meter or more from the tissue ~ite.
~ eretofore, two g~ne~al methods for accessing such tortuou~-path regions have been dsYi3ed. The first method ~mploys a highly flexible catheter having a dilated or dilatable di~tal e~d. A ma~or limita~ion of thi~
method i8 that the catheter will travel in the path o f highe~t blood flow rate, 80 many target ~it~s with low blood flow rate~ cannot be accepted.
In the ~econd prio~ ar~ m~thod, a torqueabla guide wire havin~ a di~tal bend i~ guided, by alternately rotating and ad~ancing the wire, to the target xite. ~ith the wire in place, a thin-walled cathet~r i~ then advanced along the wire until the distal catheter end i8 positioned at the targ~t 8ite. Once the cathe~er is ad~anced, the guide wire may be withdr~wn to allow fluid deli~ery or withdrawal through the catheter. A~ important advantage of this ~ethad i~ the abilit~ to control the location of the catheter aiong a ~ascular pa~hway.
Several type~ of guide ~ire6 for use in cathe~er placemen$ have been proposed. The simples~ type of wire i8 a pref~rred diameter o~ between about 8-40 mil~
(thou~andths of an inch). The di~al end of the wire may be proYided with a bent tip which ~an be o~iented, by ~eans of guide structure at the proximal end, to guide the wire along a ~elected va~cular path. Ideally, torque transmission should be oontrolled~ ~uch that a sslected wir~ rotation at the wire~ proximal end produc~s a cor-responding rotation of the distal end. Because of their greater flexibili~y, 8~aller diameter ~ires, a.g., having diameterS of be~ween about 8-18 mil~, may be required for . ~ \' p~d/9025-0017/ap 179~37 acces5ing ~m~ ~essel and/or to~tuoug-path regions.
~owe~er, if the wire i~ too ~hin along its entire le~gth, it may be difficult to transmit torque in a controllad manner along the entire wire length. Purther, the wire may buckle with axial mo~ement due to low colu~n ~trength.
Constant-diameter guide wires having a wire core enca~d in a flexible polymer tgbing ha~e also been propo3ed. Th~ flexible tubing acts to increase the column stren9th of the wire core without ~ignificantly reducing overall flex~bility. ~8 a re~ult, the problem of wire buckling, e~pecially ~n ~mall-diameter wires, i~ le~ened.
~iocompatibl~ polymers, 8uch as TEFLOND, polyolefin~, and polyurethane have been ~uitable.
More recen~ly, guide wir~s w~ich ha~e ~ultiple variable-thickne~8 ~teps along the wire length have been propo~ed. Hire8 of this ~ype ha~e the advantage that the proximal end region, where greater torsional ~rength i~
required, have relati~ely large diameters--e.g., be~ween about 20 40 mil5, and thQ di~tal end region, where gr~ater flex~bilitY i8 requirad, have progressively smaller diameter~. Typically, a ~ire of thi3 t~pe wîll ha~e dif-ferent diameter 8egment3 ~xtending collecti~ely over an approximately 25-60 cm distal poxtion of the wire, and short (typically 1-3 cm) tapered transition zone across each step. The tapered zone~ are typically formed by centerles~ ~rin~ing in whic~ the wire i8 placed bet~een two counter-rotating grinding wheels who~e confronting grinding surface~ are angled slightly to produce the de~ired taper oYer the width o~ the wheel If the tapered transition i~ ~elatively ~teep and/or tra~ition occurs in a regîon where a ~harp vessel bend i8 encountered, the wixe ~a~ bend h~rply in the -~tep (transition) zone, due to the differential bending modulus at the transition zone. If the catheter on the wire has ,~ 35 already been cldvanoed past the point of the bend, the p~d/9025-0017~ap ~3(~7~37 catheter may deform at the wire bend, making further cathet~r advance along the wire difficult or impo~ible.
Further, torqueability in the wire is ~educed at the region of a ~harp bend, ~ince torque ends to be transmit-ted through the angle of the b~end, rather ~han along theaxis of the wire.
Guide wires having e.~tended 8ections of continuous taper have al~o been di~clo~ed. The long tapered regions ha~e le~ tendency to undergo irrever~ible bending than relati~ely ~hort tapered wire sec~ions.
Howev2r, problems of wire buckling and di~ficulty in ~liding the wire within the catheter in a tor~uou~ path limit the ability of the wira and cathet~r to reach deep tissue site~.
Th~ problems of advancing a catheter ~long a guide ~ire in a gma~ umen tortuou~ sue pathway are al~o due to limitations in prior art catheter con~truc-tion. If the catheter is relatively rigid, it cannot trac~ over the final distal portion o~ the wire in the tortuou~ path region, because catheter advancement buckles the wire in a narrow turn, or because c~theter advancement pu115 the wire out of the distal vessel~ On ~h~ other hand, catheters haYing more flexible ~haft~r such as those u3ed in balloon flow-directed devices, lack the colu~n-2S strength in the ~atheter~3 proxLmal 3ection to be advancedover the guide wire without buckling, 3. Summarv of th~ Invention It is therefore one general objeot of the inven-tion to provide a guide wire d2~igned to overcome theabove-di8cus9ed lLmitations in accessing th~ tortuous path tissue site~.
A more specific ob~ect of the invention is to pro~ide such a guide wire for accessing soft tissue target ,~
pjd/9025-0017fap ~L3~ 37 ~its~, ~uch a5 deep brain ~ites, which have heretofore been inacce~Yible to catheters.
Still another ob~ec~ o~ the in~en~ion i~ to provide a catheter device for delivery of an injectable fluid or particle su~pen~ion at a tissue ~ite which can be accessed only by a tortuous ve~3sel path, which may be defined by arterie5, veins ~ or tiYsue ducts.
The in~ention includes r in one a~pect, a guide wire de~igned ~or use in guiding a catheter to a target ~ite along a tortuous ve~sel path which i5 ~t least about 20 cm long and which has ~harp-~end ~e~el ~unctions.
Such a path rQquires advancing a distal portion of the wire acro~ the ~unction, then ~liding the catheter over the ad~anced portion of the ~ire. Th~ wire ha~ three 1~ sec~ion~ with progressi~ely greater ~lexibilit~, and diff~rent lubricity or ~liding proper~ies. A ~lexible, torqueable prox~mal wire ~ection is be~ween ~bout 50-2S0 cm in length and iY foxmed of a proximal ~ire core segment haYin~ an outer di~meter of be~ween abou~ 10-40 mils. A
~ore flexible inter~diate ~ec~ion has a length between about 20-60 cm and i8 formed from an ~n~ermediate wire-core ~egment ~aYing a red~ced dlame~er of b~tween abou~ 4 20 mil~ a~d be~ween a~out 10%-S0~ of ~h~ core'~ proximal ~egment, and a flexible tube co~ering ~hich encases the intermed~ate ~ore g~gm~nt. A most flexible di~tal end ~ction ha3 ~ length between about 1-10 cm and i5 formed from a distal wire core segment h~ving a reduced diameter of between about 2-6 mil~, and a ~lexible sleeve covering the di~tal end ~egment and providing ~olumn s~rength thereto. The intermediate ~ection ha~ a low-friction polymer ~urface provided b~ the covering which makes the ~ection more lubricious than the ad~acent distal ~nd segment.
In a preferred embodiment, the proximal wire i 35 core ~egment i5 between about 10-20 mils, the inte~medi-pjd/9025-0017/ap ~3~7gZ37 a~e wire core segment has an average diame~er of between about 4-8 mil8, and the distal wire core ~egment has a diameter of between about 2-5 mils. The intermediate wire core ~egment has a sub~tantially con~tant diameter along its length, and includ~s a rela~ively ~hort region of taper bstw~en the constant-diametar portion~ of the di~tal and intermediate wire core segment. The di~al wire core segment ha~ a 8ub5tantially continuous taper along it~
length. Pre~erably the guide wire ha~ a ~ub~tantially constant outer diameter alony it~ length.
A180 in a pre~erred embodimen~, ~he flexib1e polymer covering in the intermediate ~ection is a polymer tube which i8 effecti~e to increase the col~mn strength of the intermediate section, and which ha~ a low-fri~tion polymer coating. The slee~e CoYering i~ a helical ~oil formed from a radio-opaque me~al s~rand material.
In another aspect, ~he in~ent~on includes a ~atheter device for u~e in accessing a ~arg~t ~ite alon~ a tortuous ve89el path. ~he device Lncludes a guide wire of the type de~cribed above and a cathe~er designed ~o be ad~an~ed ove~ the wire, ~ith ~uch advan~ed to the target site.
In a preferred ~mbediment, the cathe~er has a relatively 8tiff proxLmal t~be ~egment dimensioned to track the wire along it proxLmal end 3ec~ion, and a relatively flexi~le distal tube ~e~ment constructed and dimen~ioned to track the ~re a1Ong it~ intermediate and distal end ~e~tio~s~ Al~o in a preferred embodiment, the ca~heter has a ~Ubstantially constan~-diame~er inner lumen, the wire has a substantially con5tant diameter along itC length, and cLearance between the wire and the inner catheter lumen of about 2-S mils.
These and other objec~s and features of the invention will become more fully appreciated when the ol-pjd/9025-0017/ap ~L3~7~87 lowing detailed description o~ the in~ention is read in conjun~tion with the accompanying drawings.
Brief De~cript_ n o~ the__rawin~
Figure 1 shows fragmentary portions of a guide wire constructed according to one embodiment of the present invention;
Figure 2 shows ~ragmentary portion~ of a guide wire constructe~ accord~ng to anoth~r embodim~nt of th~
invention;
~ igures 3 and 4 are e~larg~d si~e views of ~
discrete (Figure 3) and continuous (Figura 4~ taper in the tapered region of an embodiment of the guide wir~ Yuch a~
shown in Pigure l;
Figures 5 and 6 are anlarged sec~ional views of diff~rent embodim~nts of flexible ~lee~e~ ~uitable for covering the distal end regions of the ~uide wir~
constructed ac~ording to the in~en~ion;
Pigure 7 show~ a eatheter device construc~ed according to the pre8ent ln~entlon;
Figure 8 ~how~ an enlarged ~ection o ~he cath~ter device i~ Figure 7, taken alon~ ~he region 2~ indicated ~t 8-8;
~ igure 9 illu~kra~e~ a por~ion o~ a tortuou~
path in a ~oft ti88Ue~ and a ca~heter and guide ~ire being advanced along this pa~h;
Fi~ur~s 10 and 11 are enlarged regions o~ the Figure 11 path, 8howing the s~eps in ad~ancing the catheter through a sharp-bend ~unction in the path.
p~d/902~-0017/ap IL3~g~7 Detailed Description ~t ~h- InventinA
I. Guide Wire Figure 1 shows a guide wire 20 cons~ructed ac-cording to one embodlment of the in~en~ion. The wire i~ aflexible torqueable wire ha~ing an overall length of be~ween a~out 70-300 cm ~tween its praximal and di~tal ends 22, 24 J re~pectlvely, and a maximum outer diameter of between about 8-40 mils (thousandths of an inch). The ma~or portion of the wire is a flexible proxLmal ~ection 26 who9e overall length range~ from about 40-250 cm. This section is followed by a more flexi~le intermediate 3ec-tion 28 having a len~th between about 15-60 ~il~, ~nd a mo~t flexible distal end ~ection 30 who~e length i8 betwe~n about 1-10 cm. It will be apprec ~ated that the wir~ i~ hown in greatly exaggerated radial s~ale, and that 8 ma~or portion of the distal end ~ection has been cut away.
A wire core 32 in th~ yuide wire is ~ormed o a 20 flexiblç!, torqueable wire filam~n~ material, such as ~tainles~ . teel. The diameter of the wire core, at it~
maximum, i~ between about 8-40 mil~. The 3egmen~ of ~he core forming the prox~mal ~ec~ion o~ the guide wire, indicated ~t 34, h~ a sub~tantiall~ uniform diameter 25 along it5 lengl:h, and corre~ponds to the maximlam diameter of the core, i-~-, between 8-40 mils.
Within the intermed~ a~e section of the wire, the core i~ tapered from the proximal-~;ection diameter down to a reduced diameter which i~ pre~erably about 4-20 mils and 30 between about 10%-50% of the core ~ 5 proximal esegm~nt diameter . Thus, for example r where the proximal section core diameteL i3 18 mils, the core tapers tc~ a minimum of between about 2~9 mils.
In the embodiment 3howr~ in Figure 1 r the taper in the core occurs o~er a relatively short tapered segment p~d/9025-0017/ap ~L3~ 7 36 which iR followed by a reduced-diame~er 3e~ment 38 hav-ing a ~u}~stantially con~tant s~iameter along it~ leng~h.
The length of the tapered segIInent is ~ypically between a~out 10%-50% that o~ th~ con~itan~-diameter, and the two 5 ~egment~ togeth~r make up the leng~h of the intermediate wire section, i-e-, about 20-60 c~o.
The tapered ~egm~nt in the Pigure 1 wire e~odiment iB Jhowll Ln enlarg6!d sti~w in FigurQ 3. Thi~
t~pe of taper may be thought of as a di~crete taper, in 10 that the profile c~f the taper~d qecltion wflll i8 linearl and th~ segmen~: inter9eC:t3 the opposed coII~tant-dlameter segment~ at discrete angle~ at l:he an~ular :cegion~ 40a, 40b in the fig~- Figure 4 shnws a ~capered s~gment 42 o~
a wire core 44 formed ln accordance ~ith emother 15 ~odiment of the in~rerltion. }Iere~ the ~lope of the taper i8 c9ntinuouslY ~a~in~3, ~d the ~egm~nt ha~ the gellerally s-3haped wa~l profil~ 88en. ~he 'capE~r ~segment illu3trated ~n ~gure 4 ~8 generally preferred Yince it ~inimize~
bending and tor~ue-t an~ai~3ion dif~ll3x~ntials at ~nd~ of 20 the tape~ d 3~agme~ l~ethods of fonning ~he t~o typ~8 o:
tapers will be d~cu~sed bs~low.
The twn segmen~ ~akinçl ~p the core of the intermediate se~:tion o~ sire ar~ covered along their lerlgth by a flexible polymer covering ~6. The i1~a~0r func-25 tion of the coY~ring i8 to pro~ridE~ a, ll.abricaous ( low-friction) 8llrfa~:e along the i~tesm~çlia~e ~ection, arld more p2~:icul~rly, a ~urface ~hich i.~ Dlore lulsricious than th~
surface of the ad~acent; distal ~e~gment of the wire and o~
the wirE3 core- The covering prefera~ly also func~ion~ lto 30 prostid6~ c~l~amn 8UppO~: ~:0 the reduced-diameter corE~ ~n the intenned~ ake g3QCtion, to r~duc~ the tendency of ~hi~ ~ec-tion to buckl~ under axial c:ompre~ion .
Co~v~ring 46 i8 preferably ~ormed of a polymer, 3uch a~ TEELON~, polyole~in, or polyurethane which can be 35 bonded or oth~ e tightly a~ixed ~o the core wire, and pjd~902~-0017/ap -- .... ~ ~ .
~3~7'~7 which itself ha9 a low-frlction ~urface, as i8 the ca~e for TEFLON~, or who~e surface can be coa~ed with a low-friction ~urface. Other ~uitahle coveringC include a tube formed from ~irtually a~y pol~ner having exposed S hydrogen~, such as polyester~ polyolefins, polycarbonate, poly~inylchloride, latPx or silicon rubber, poly~tyrene, and polyacrylic~, and a ~urface coa~ing formed of a highly hydrophilic, low-friction poly~ler, such as poly~inylpyrrolidone (PVP), polyethy~eneoxide, or polyhydroxyethylmethacryla~e (polyHEMA) or copolymers thereof.
In the embodiment ~hown in ~igure 1, covexing 46 is ~ormed of a relatively thick-walled tubing 48 a~d a ~urface coating 50 of a low-friction pol~mer. The inner diameter of the tubing is such a~ ~o form a tight fit o~
the tubing on the wire cor~, and the outer diametar is substantially the ~ame as ~hat o~ the core wi~e proxLmal ~ection. Thus the proximal and intermedi~P wire sections have ~ub~tantially the same outer diæmeters, e.g., between about 8-40 mil~- The ~egm~n~ o~ the tubin~ encasing tapered sectio~ 36 preferably has a complementary taper, as ~een be~t in Figure 3.
The low-~ric~ion polymer coa~ing may al~o co~er an ad~acent portion of the wire'~ proximal ~ec~ion, a~
~hown in ~igure 1- Typically, ~he coating will be ~pplied to the 20 50 cm of the di~tal ~ction core adjacent the intermediate ~ectio~- AltQrnati~ely, the proximal section core may be coated with a le88 lubriciou~ protecti~e coat-ing material, ~uch a8 silicone coating or the like.
With continued r~erence ~o ~igure 1, di~tal ~ection 30 of the wire ha~ a length between abo~t 1-10 cm and preferably has still grea~ex flexibility than the intermediate wire 8ection. The w~re core in the distal ~ection, referred to a8 8~ment 54, has a diameter which i8 ~ubstantially no great~r than that o~ the intermediate p~d/9025-0017/ap ~3~ 37 section cor~, and preferably is tapered to a reduced diameter of between about 2-6 mils. In ~hs embodLment ~hown in Figure 1, the core has a linear t~per over its entire length- Alternatiy~ly~ the core may contain one or more di~crete tapers.
The di5tal ~ection portion of ~he core is ~ully or partially encased in a fle~cible 81eeve. The sleeve 3hown in Figure 1 i5 a ~oft, ile~i~le helical coil 56 which i~ formed Conventionhlly~ e.g., as a winding of radio-opaque wire ~trand, ~uch as platinum, gold, or tung~ten ~trand- As ~hown, the coil extend3 from covering 46 to the di8tal end of thQ wire core. The coil prefer-ably ha5 a fixed-dimen~ion inner diameter, as shown, or may be tapered, e.g., to match the ~aper in th~ core. At-tachment of the coil t~ the core i~ preferably by two orthres 801der o~ weld ~oints, including a proxLmal ~oint 60 and a round~d di~tal ~oint 62. An intermedia~e ~oint ~not shown) ~erve~ to tran~mit torque in ~he wire to the coil, to cau~e the end region o~ the guide wir~ to ~end slightly at thi~ golder ~oin~t to allow ~he wire to ~e guided in a ~elected direction in a ve~sel nQ~work, by torgueing the proximal end of the wire. The c:ore and ::oil call be ir-rever ibly ~haped, prior to u~e, to includle w~re bend use-ful in guiding the wire.
In addition to providlng a mechani~3m for wire bending near the wire tip, ~he coil also gives th~ distal R~ction of the wire in~:reased ~:olumn ~treE~gth ( in the axial dir~c~ion), and reduces the chance of bucXling in thiY ectiorl with axial compression~ At the ~me 'cime, the com~ined flexibi.~ity of the reduced diam~ter core and the coil are compatible with a sesie~ of ~harp bends, as ~he wire is mo~ed through a tortuous pa~hway in the target tissue. The rounded ioint at the end of the wire act~ to shield vessel walls from the sharp end of the wire core.
i 3S
p~d/9025-0017/ap ~l3~87 According to an ~portant f~akur~ of the inven-tion, the distal 8etion of the wire, including the ~leeve encasing the wire core in this ~ection, i8 l~s lubri-ciou~, i.e., has a higher ~ric:tional coefficient, than that of the ad;acant intermedi.a~e section. The higher-friction ~urface in this secti.on functions ~pecifically, during a catheter placement operation, to help anchor the di~tal -qection again3t a ve~8el wall at a va~el ~unction, a~ will be 9een below. The hi.gher ~riction can be achieved in a number of way~. Where the ~lee~e is a coil, the coiled 9urface inherently h~ a higher ~urface co-efficient than a low-~riction pol~mer coa~ing.
Figure 5 i8 an ~nlarged gectional Yiew of a di~tal 8ection of a wire ~uch as ~hown in Fiyure 1. The ~5 coil in the 8ection, here indicated at S4, i3 formed as a helical winding of a radioopaque ~rand 66 which ha~ been precoated by a polymer cover 67. ~h~ polymer can be selected for lo~- or high-~riction surface propertie , to ~electi~ely vary the frictional pxoper~ies of the ~leev~.
2~ Alternati~ely. a coil form~d from a bare strand ~ay be coated, after attachment to the wire core, with a ~uitable protect~e polymer, such as ~ilicon or the like.
In another ~mbodiment, tho ~leeve in the diYtal ~egment may be a polymer tubing which i8 both fl~xible and capable of providing colu~n str~ngth to ~he distal-section wire core. The tubing, if formed t~ ha~e a smooth ~all~
can be made from a ~ariety of polymers, ~u~h ~s poly-ethylene, latex or the lik~, which have relativel~ high frictional coefficients. Alterna~ivaly, ~he sleeve may be formed with ~urface feature~ which increase ~he frictional coefficient 8ub8tantially. One such sleeve i~ ~hown in enlarged vie~ in Fi~ure 6, showing a por~ion of a di~tal section 8imilar ~o Pigure 5. Here the distal ~egment of the wire cor~, indicated at 70, i3 ~ncas~d in a polymer tube 72 havirlg a series of annular groove~, ~uch as ., p~d/9025-0017/ap ~L3(~79~7 qrooves 74 form~d in it~ surfacQ. It can be ~pprsciated that the~e grooYe~ pro~ridl3 incraelgE2d t~ ~lexibili~y a~
well 218 greelt~r frictional co~f~ ien~ at thla ~ame time, th~ added column ~trength corltributed by ~h~ tube i8 5 ~ub . tantiall~ pre~e~d sinc~ axial c~pre~ion on th tu}: e a~-t~ to preB8 th~ greo~ed rE~g~o~ a~in~ one ~nothor. The polymer ~le~re i8 pr~afQr~Lbly pro~ided wlth .
radio-~paqua band ( no~ ~hown ] .
Pi ~e 2 ~hc~ guid~ 80 corl~truct~d ao-10 cording to a ~concl ~s~neral ~bodl~t of th~ ~ nvention .The ~ire haB prox~l, :Lnt0rm~cuatt~ d di~t~ ctions 82, 84, B6, ~p~cti~lBly, uad ~ eo~e ~ith corrE~Ypond-ing cor6~ JQg~9~ltJ 38 ~ 90, 92, ~eJpec~ . The wl~ di for~ fr~ th~lt ~ho~ tho ~ cor~ has 15 a cont$nuou~ ~ (or, ~ ti~ly, ~ s:ont~uou~ S-shaped CllrYe ) through tha l~t~ ~d di3~al ~tions ~th~r ~ hoa~ r ~E~d ~ nd a lorlgex r~duc~d~a~t8r llQ9~nt. Th~ o~ o~
including ~ pol~er 8u~:f~:o co~ 4 e9h~ch p~r~d~
low-friction ol~fae~ s th~ t~ ~osXlo~a and an ad~c~ o~ of t:he d~al J~o~a, ~ 8t~b~tantially ~d~nt$cal to tho~ r~6~ r~ferQns::~ to ~igur0 1.
~n for~ing th~ g~ o~ ~ao L~r~ntionq t:h~
cors $~ lly C~
comr~ntional, S~lut~lt~ r çp.l~ ~ ch ~ i~
com~ a~ 98~ W~10. SteEI
grinding ~n b~ u~ed to fosm r~ t~ y ~hort tap~ræl ~eç~nt~, ~uch æ~ in fo~g ~h~ cog~ Pigax~
30 ~e. ~ hod~ Of i~os~in~ ral~ lon~, eollti~uou~ly tap~r~d c05:~ (Pigur~ 2) ~n~ non l.inelar t~pgtrecl r3gions ( Figur~ J~ ) h~ve ~1l d~cr~bQci in eo~me~d PC~ p~tent applic~t~on for ~Catheter ancl ~1~8ue~ sing M~thod", ~7~87/07493, file~d D~c~ ar 17 ~ 7.
~ e .~ J
p~dl9025-0017/ap ~3~3~7 The f lexible polymer ~ube c~vering the inter-mediate cor~ is 8egment ( s ) can be applied t~ ths core by conventional pol~mer spraying or dipping methods, or b~
a~taching a preformed polymer tube ~o the core ~egment ( 8 ) .
5 The latter can be accompli3hecl by attaching the tub~ to the coxe under heat ~hrinking condition~3, or by securing ~he tube to the wire by a suit:able wire/polymer bonding agent . A6 indicated above, the lubriciou~ ~urf ace coating may be formed by the ~urface of ~he covering, or prefer-10 ably, by applyins a lubricious pol~er surace coating.Such a surface coating, which preferably c:ovl3r~ a portion of the distal section, can be applied by spraying or dipping, according to known method~.
15 II. Catheter Device Figure 7 ~hows a c:athe~er device 100 constructed according to one aspect of ~he inven~ion. The de~ e include~ a catheter 102 which will b~ descxibed below, and a gui~e wire ~ h~3re indicated at 104 t of ~he type de~cribed 20 abr~ve. The de~rice i~ d~3~igned for acc:esRing a target ~i~e which can be r0ached only along a small lumen tor~uous path ~ithin a target tis~ue, a~ will be described with reference to Figure~ 9-11 below.
With reference to Pigure 7, ~::a~heter 102 i5 ~ormed of a flexi}:)le tube 110 which i~ dimen~ioned to reCQi~e the guide wire therethrough, a~ shown. In a prefsrred embodim2nt of the invention, the catheter has a relatively 8tiff pro~Lmal segment 116 which ~ake~ up between abo~ 70%-95~ of the total tube length, and a relati~elY flexible diBtal segmen~ 118 which makes up the remaining approxlmately S%-30% of the tube length. The construction of a catheter of this type haR been detailed in above-melltiOned PCT patent application for l~Ca~heter and Ti~sue i~cceBsing Methodl~. Briefly, and with xeference to Figure 8, the relatively stiff ~ec~ion of the tube i~
" ~
pjd/9025-OU17/ap ~3~7~
composed of inner and outer coaxial tubes 120, 122 which are tight-fitting with respect to each other. The ~tiff-ness in the proximal ~egment i.~ provided predominantly by tub~ 120. The in~er~ ~tiffer tube i~ preferably S polypropylene or high-den~i~y polyethylene tubing ha~ing a final wall thic~ness (in the a~sQ~led cathe~er) of be~ween about 2-4 mils. The outer, more flexibls tube i8 preferably low-den~ity polyethlylene or ~ilicone tubing, also h~ving a preferred wall thickne~s o~ between about 2-4 mil3.
Wlth continued referen~ to Figure 8, the innerdiameter of the proximal segmant is d~men~ioned, with respect to the guide wire, to pro~ide ~uf icie~t wire clearance to all9w the catheter to ~e ~oved ea~ily o~r the wire in an axial direction, during cathe~er placemen~
~t the target ~ite. The guide wire its~lf mu~ have a relatively 9mall diameter, to penmit ~t~ guided movement along a tortuous path ~n a target ti~ue, In a preferred embodiment of the in~ention, the inner diame~er of the catheter and the outer diameter of the guide wire are sub~tantially conBtant along their length~, and the clear-ance between the two ~s between about 2-5 mil~. Thu~ r for exampl~, a catheter de~igned ~or u~ wi~h constant-diameter guide wire ~ho~e outer di~met~r i~ 18 ~il8 ha~ a Z5 preferred inner dia~eter of 20-25 mil~, and more prefer-ably 21-22 mils- The pr~f~rred cl~arance betwe~n the wire and ~nner wall of the ~egment reduces the ~endency of the ~egment to buckle under compre~sional ~rain, since the wire prcvides col~mn ~upport against tube bending and crimping.
The optLmal length of the proximal segment will vary ac~ordi~g to the di~tance between the ti8sue region which i~ to be accessed by the ca~hete~ and the external , ~ body ~ite at which the catheter is introduced. In a preferred embodiment, the total length of tha catheter p~d/~025-0017/ap ~3~73~37 distal ~ection is about the sam~ length a~ that of the intermediate and distal wire ~ections combined~
Completing ~he de~cription of the c~theter, and with r~ference to Figure 7, the free end of the proximal segment is attached to a fitting 124, such as a standard syringe fittin~, for u~e ~n connecting a ~yrin~e to the cathet~r ~or f luid in j ection and withdrawal. At the distal end of the cath~ter~ a radio-opaque band 125 (Figure 9), such as a gold or platinum band, serve~ as a marker for following the position of the ~a~h~er radiographically.
III. O~eration The method of inser~ing the catheter ~nto a ti~sue region which is rea~hed ~y a tortuous path will be described now with reference ~o Figure 9~ The fiyure ~hows a region o~ oft ti83ue 1~0, such as brain tissue, containing a target site 142. Ini~ially the ~ide wire, indic~t~d at 104, i~ ~ed ~ro~ a vaficular acce~ region ad~acent the target tiRsue i~to a ti~ue-~upply ~es~el 144 which ~xtends into the ti~su~. In the pr~ nt ~xample, the tortUoU9 path to the targe~ e ~nvolves ~es el 144, a ve~5el 146 which bra~ches off ~es~el 144 at more than right angle, and branch ~e~el~ 14B and 150 which each branch off the preceding ~essel as ~hown. The path ~hown involve~ (a) a numb~r o~ bends, s~me of which may be 90 degrees or more, ~b) 8mall ~Qs~ls, typically with lumen diameters of les~ than about 3 mm, and ~c) a total path length ~ithin th~ target tis~ue of at least A~out 10-20 c~
In operation, the cath~tQr device i~ threaded as a unit from an external access site ~hrough the ~a~culature tc~ a region ad;acen~, but not intu ~he tortuous path region of the target tissue. This is done, in the usual c:a~e where the catheter must pa~s through the pjd/9025-0017/ap 13~;7~7 cardiac aorta, by first placing a relatively laxge diameter guiding catheter ~e.y., about 40 mils inner diameter) $rom the acce~ sit~ through the aorta and toward the target ~ite. ~he pre~ent catheter device is S then threaded through the guiding ~atheter pa~t ~he aorta, where large ve~sel di~m~ters and high blood ~low volumes make it difficult to control the movemen~ and position o~
the catheter. Once beyond the guiding catheter, the catheter device can b~ advanced as a unit toward the target site~ In genera1, ~he path from the acce~s site to the region ad~acent the ti3sue i~ ea~ily acce~sibler in that ~harp bends, 8ma~ u~en vesse~ nd/or ~oft tis~ue ~tructure are not encountered~
Typically, when the tortuou~ pa~h tis~ue region 15 i~ reached, and particularly where ~harp bends in the path are æncountered, the wire iæ advanced ahead of the catheter. Thi~ i~ done ~y advancing the wire axially within the catheter and at the ~ame ~im~ torqueing the wira to orient the bent tip o~ the wire in ~he direction of desired wire ~o~ement. Af~er the wire has been 50 ad~anced, the catheter i~ then advaneed o~er the wire until the catheter end i clo~e to th~ wire ~nd. Thi~
procedure i~ repeated until the wire and catheter have been fully ad~anced through the 8mall-dlameter ti~sue vessel region to the taryet ti~sue ~ite.
The features o~ the presen~ in~ention which c~ntribute to it5 ability to reach targe~ ~ites along tortuou~, ~oft-tis~ue path~ can be appr~ciated from ~igure~ 10 and 11, whiGh ~h~w an enlarged p~rtion of the region 140 illdicated at dash-dot line 151 in Figure 9.
Figure 10 ~how~ ~he con~iguration o the catheter just after the di~;tal ~ection of the guide wirer indicated at 152, has been advanced ahead of the cathe~er into bran~h vessel 148 fl-om ~essel 146~ The wire advance i~ achieved by fir-~t tor~Iuing the wire to orient the wire bend toward pjd/9025-0017/ap 31~7~7 Y~ssel 148, then moving the wire a~ially until the wire end move~ into the branch ve~sQl.
Wi~h the wire now hE~ld in it~3 advancsd position, the cath~ter ig moved axially over the wire, in the 5 direction of the ~es~el branch~, It can b~ appr2c:iated fsom ~igure 10 that molrement of th~ catheter ov6!~ th~ wire bend ~ndica$ed at 1~6 cai~se3 this region of thE3 ~ir~ to straighten, with the e~fi3ct of increasing the force of 'che catheter di~tal ~ection agains1- t:he ~ide of ~e~sel 148.
10 If the frictional force l~etween th~a wi:re ~nd region and the ~re~3sel i~ ~uite low, ~che ~nd rç~gion o~ l:he ~rir~ ~ithin vessel 148 will now tend to ~lip out o~ the ~ 1, since the wir~ in thi~ region i~ ~ery fl~ and ~asily capable of fo~nçl the type~ o~ ro~ g loop rleeded to 1~ excricats it8elf from ~88el 1~. E'G~ l:hi8 rea~orl, it i8 important that the 8u:rfEIce of ~che d.~.~tal ~gion of the wire be 2~ relatiY~ly high-fric~ior~ Ear:e.
It i~ al30 ~een in P~gurs 10 that th~
interm~diate 8~ 0n of th~3 wir~ 3re indicatE~d at 160, 20 i8 containi3d larg~ly within ~hQ c:athe~er a~ the distal ~ect~on of the wire i8 ac~cad throug~ thç~ 3el ~:canch ~unction. ~at 4ach b~nd in t~ thetE~x, the wire il!3 pre~i~ed again he ad~acen~ wall ~sRction of the catheter, as ~h~wn at ~end 162. ~his ~ressur~, it can b~ ~e*n, lncr2ase3 the ~sictional resistanc~ oun~ered in ~o~in~
the wire axi~lly ~ith~n th~ ca~heter~ In par~icular, it h~s been found with prior art wir~s ~ha~ two or ~ore ~uch ~iharp bend~ in ~he cathet~r can ~ake it ~mpo3~ible ~ither to advance the guide wira rela~iv~ ~o ~hQ ~atheter~ during cath~t~r plac~ment, or ~o ~emo~e th~ wire af~er placement.
Ac~ord~ng ~o an important feature o~ the inven~ion, ~his problem i~ ~ol~ed ~ub~tantially by th~ low-~riction gurface on the intermedia~e wire Rection.
To illu5trate, as the cath~ter in Fi~ure 10 i~
ad~anc~d o~ the distal ~i~c~ion of the wire t~ ~he pjdt9025-0017/ap ~ 3~79B7 position shown in Figure 11~ only the most diYtal bend will inYol~e a hisher-friction portion of the wire, although the low-riction intexmediat~ ~ection may ~n~age the catheter at 8everal bends. Even along khe di~tal wire section, the force needed to o~ercome the fr ctional re~istance between the wire and di~al catha~r 3ection i8 reduced by high flexi~ility of this segmen~. Similarly, the relatively high ~lexibility of the wire'~ interm~diate ~action cooperates with the low-friction -~ur~ace to facilitate axial movement of the wire in the catheter in a tortuous path.
Summarizing the Lmportant features of th~
invention, the greater flexlbility ~n the distal and intermediate 3ections of ~ha guide Wir3, r~lated to th~
reduced-diameter feature of the wire core, allows the wire to be guided along a tQrtuous 3mall-ve~s~l path in a ~oft tissue, for acce~ing deep-ti~u~ ~ites. The high flexibility in the8e 3ections al~o reduce~ frictional forc~ ~et up between the wire and catheter ~n bend regions along the acce~ path.
~ hD relati~ely high friction -~urface of the di3tal 3ection i8 required in anchoring the di~tal section of the ~ire within a branch ~es~l, aæ the ca~heter is ad~anced acros~ the ~unc~ion. By contra~, the low-2~ friction ~urface of the intermedia~e -~ection acks to minimize th~ frictional resi~tance to axial wire moYement through the cathet2r at regions o~ sharp be~ding in the catheter. Thi8 a11Ows the wire ~o slide ~and ro~a~ed~
within the catheter with gr~a~er ea~e and reduces the liklihood that the wire will become ~mobilized within the cathQter during a placemen~ operation.
In a preferred embodimen~ of the in~ention, a portion of th~ proxLmal wire section ad~acent the intermediate S~ction is also provided with a low-friction ,., i ` 35 ~urface, i.e-, ~ubs~antially lower than that of the wire p~d/9025-0017/ap 13~7~7 core, to further reduce frictional resis~ance to wire movement. The more proximal portion of this ~ection which will ~e handled by the user in guidi~g th~ wire from a body-access site to the target site pre~erably has a highsr friction surface, to al:Low the wire to be manipulated without 31ippag~.
Also in a preferred embodiment, the low-friction covering in the intermediat~ ~ection i~ fo~med of a flexible tube which gives col~n ~upport to the wire core.
10 The greater column ~trength allows higher axial force to be applied to the wire in a catheter placement operation, without wire buckling. Where ~he guide wire and catheter esch have constant diameters along ~heir length~, and a clearance of 2-5 ~il~ between the two~ ~he catheter al~o serve~ to r~ t wir~ bu~ling.
Additional ad~antages, in term~ of ~arget-site acces~ibility, are gained when ~ha guid~ wirs i~ used with the gradient-~lexibility catheter d~cribed above. The greater flexibility in th~ d~3~al region of ~he catheter allows the cathet~r to follow or tracX a wire bend wi~h le~ axial ~orce, ~inca cathe~er defonmation i~ redu~d.
Further, becau8e the catheter Qnd region fl~xes more easily, it exert~ less force on the distal section of the wire when bein~ ad~anced through a branch ves~el ~unction, RO the wir~ 8tays anchored in ~he branch vessel with les~
frictional re~i~tance betw~Rn the wire and ~essel wall.
Preliminary clinical ~ud~g with the pre~ent invention indirate that the guide wire/catheter ean be guided to deep brain 3ites which have been inacce~si~le previou~ly- The8e 8ites typically i~volve catheter guidance along a 15-25 cm brain ves~el pathway which ha~ 2 to 6 ve~s5el ~unctions where ~harp ~urn5 are encountered, and spacing between ad~acent turns of between about 1 to 5 `~`I"` cm.
pjd/9025-0017/ap 13~P7~3~7 While the in~ention ~las been described with respect to particular em~odiments and u~es, it will be appreciated tha$ variou~ changes and ~odificationS can be made without dep~rting from ~he scope of ~he invention~
S
1~
p~d/9025-0017~ap
Claims (15)
1. A catheter guide wire designed for use in guiding a catheter to a target site along a tortuous ves-sel path which is at least about 20 cm long and which has sharp-bend vessel junctions, requiring advancing a distal portion of the wire across the junction, then sliding the catheter over the advanced portion of the wire, said guide wire comprising a flexible, torqueable proximal wire section between about 50-200 cm in length and formed of a proximal wire core segment having an outer diameter of between about 10-40 mils, a more flexible intermediate section having a length between about 20-60 cm and formed from an inter-mediate wire-core segment having a reduced diameter of between about 4-20 mils and between about 10%-50% of the core's proximal segment, and a flexible polymer tube covering which encases the intermediate core segment, and a most flexible distal end section having a length between about 1-10 cm and formed from a distal wire core segment having a reduced diameter of between about 2-6 mils, and a flexible sleeve covering the distal end seg-ment and providing column strength thereto, said intermediate section having a polymer surface coating which makes the section more lubricious than the adjacent distal end segment and said wire core.
2. The guide wire of claim 1, wherein the proximal wire core segment is between about 10-20 mils, the intermediate wire core segment has an average diameter of between about 4-8 mils, and the distal wire core segment has a diameter of between about 2-5 mils.
3. The guide wire of claim 2, wherein the intermediate wire core segment has a substantially constant diameter along a major portion of its length, and includes a relatively short region of taper between the constant-diameter portions of the distal and intermediate wire core segment.
4. The guide wire of claim 2, wherein the distal wire core segment has a substantially continuous taper along its length.
5. The guide wire of claim 1, which has a substantially constant outer diameter along its length.
6. The guide wire of claim 1, wherein said covering is composed of an inner polymer tube formed from one polymer material, and a surface coating formed from a second, more lubricious polymer material.
7. The guide wire of claim 6, wherein the intermediate section has an outer diameter which is substantially the same as that of the distal wire core segment.
8. The guide wire of claim 1, wherein said sleeve is a helical coil formed from a radio-opaques metal selected from the group consisting of platinum and gold.
9. The guide wire of claim 8, wherein the distal end section has an outer diameter which is substantially the same as that of the intermediate sec-tion.
10. A catheter guide wire designed for use in guiding a catheter to a target site along a tortuous ves-sel path which is at least about 20 cm long and which has sharp-bend vessel junctions, requiring advancing a distal portion of the wire across the junction, then sliding the catheter over the advanced portion of the wire, said guide wire comprising a flexible, torqueable proximal wire section between about 50-250 cm in length and formed of a proximal wire core segment having an outer diameter of between about 10-20 mils, a more flexible intermediate section having a length between about 20-50 cm and formed from an inter-mediate wire-core segment having a reduced diameter of between about 4-8 mils and about 10%-50% of the core's proximal segment, and a flexible polymer covering which encases the intermediate core segment, and provides column strength thereto, and a most flexible distal end section having a length between about 1-10 cm and formed from a distal wire core segment having a reduced diameter of between about 2-6 mils, and a flexible radio-opaque helical coil covering the distal end segment and providing column strength thereto, said intermediate section having a hydrophilic polymer surface which makes the section more lubricious than the adjacent distal end segment, and said wire core.
11. A catheter device for use in accessing a target site along a tortuous vessel path which is at least about 20 cm long and which has sharp-bend vessel junc-tions, said device comprising a guide wire having (i) a flexible, torqueable proximal wire section between about 50-250 cm in length and formed of a proximal wire core segment having an outer diameter of between about 1-=40 mils, (ii) a more flexible intermediate section having a length between about 20-60 cm and formed from an intermediate wire-core segment hav-ing a reduced diameter of between about 4-20 mils and between about 10%-50% of the core's proximal segment, and a flexible polymer covering which encases the intermediate core segment, providing column strength thereto, and (iii) a most flexible distal end section having a length between about 1-10 cm and formed from a distal wire core segment having a reduced diameter of between about 2-6 mils, and a flexible sleeve covering the distal end segment and providing column strength thereto, where the intermediate section has a low-friction polymer surface which makes the section more lubricious than the adjacent distal end seg-ment, and a catheter designed to be advanced over the wire, as the wire is moved toward the target site.
12. The device of claim 11, wherein the catheter includes a relatively stiff proximal tube segment dimensioned to track the wire along the proximal end sec-tion thereof, and a relatively flexible distal tube segment constructed and dimensioned to track the wire along the intermediate and distal end sections thereof.
13. The device of claim 12, wherein catheter has a substantially constant-diameter inner lumen, and the wire has a substantially constant diameter along its length.
14. The device of claim 13, wherein the clear-ance between the outer surface of the wire and the inner lumen of the catheter is between about 2-5 mils.
15. The device of claim 12, wherein the clear-ance between the outer surface of the wire and the inner lumen of the catheter is between about 2-5 mils.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US07/182,870 US4884579A (en) | 1988-04-18 | 1988-04-18 | Catheter guide wire |
| US182,870 | 1988-04-18 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1307987C true CA1307987C (en) | 1992-09-29 |
Family
ID=22670408
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA000596938A Expired - Lifetime CA1307987C (en) | 1988-04-18 | 1989-04-17 | Catheter guide wire |
Country Status (8)
| Country | Link |
|---|---|
| US (1) | US4884579A (en) |
| EP (1) | EP0411040B1 (en) |
| JP (1) | JPH03505168A (en) |
| AT (1) | ATE110972T1 (en) |
| AU (1) | AU624383B2 (en) |
| CA (1) | CA1307987C (en) |
| DE (1) | DE68918092T2 (en) |
| WO (1) | WO1989010088A1 (en) |
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-
1988
- 1988-04-18 US US07/182,870 patent/US4884579A/en not_active Expired - Lifetime
-
1989
- 1989-04-14 AU AU35543/89A patent/AU624383B2/en not_active Ceased
- 1989-04-14 EP EP89905541A patent/EP0411040B1/en not_active Expired - Lifetime
- 1989-04-14 DE DE68918092T patent/DE68918092T2/en not_active Expired - Fee Related
- 1989-04-14 WO PCT/US1989/001591 patent/WO1989010088A1/en active IP Right Grant
- 1989-04-14 JP JP1505236A patent/JPH03505168A/en active Granted
- 1989-04-14 AT AT89905541T patent/ATE110972T1/en not_active IP Right Cessation
- 1989-04-17 CA CA000596938A patent/CA1307987C/en not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| ATE110972T1 (en) | 1994-09-15 |
| JPH0581272B2 (en) | 1993-11-12 |
| DE68918092D1 (en) | 1994-10-13 |
| AU624383B2 (en) | 1992-06-11 |
| EP0411040B1 (en) | 1994-09-07 |
| US4884579A (en) | 1989-12-05 |
| JPH03505168A (en) | 1991-11-14 |
| AU3554389A (en) | 1989-11-24 |
| EP0411040A1 (en) | 1991-02-06 |
| DE68918092T2 (en) | 1995-01-12 |
| WO1989010088A1 (en) | 1989-11-02 |
| EP0411040A4 (en) | 1991-04-03 |
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