CA2256401A1

CA2256401A1 - Low profile catheter valve

Info

Publication number: CA2256401A1
Application number: CA002256401A
Authority: CA
Inventors: Gholam-Reza Zadno-Azizi; April A. Marano-Ford; Celso J. Bagaoisan; Jefferey C. Bleam; Isaac J. Kim; Jeffrey F. Field
Original assignee: Percusurge, Inc.; Gholam-Reza Zadno-Azizi; April A. Marano-Ford; Celso J. Bagaoisan; Jefferey C. Bleam; Isaac J. Kim; Jeffrey F. Field; Medtronic Percusurge, Inc.
Current assignee: Medtronic Vascular Inc
Priority date: 1996-05-20
Filing date: 1997-05-19
Publication date: 1997-11-27
Also published as: WO1997044085A3; DE69732104D1; US6355014B1; EP0906135B1; IL127179A0; WO1997044085A2; US6500166B1; JP3690815B2; JP2000511082A; ATE285812T1; EP0906135A2; DE69732104T2; AU3132097A

Abstract

Disclosed herein is a low profile catheter valve comprising a movable sealer portion positioned within the inflation lumen of a catheter. The sealer portion forms a fluid tight seal with the inflation lumen by firmly contacting the entire circumference of a section of the inflation lumen. The sealer portion may be positioned proximally of a side-access inflation port on the catheter, to establish an unrestricted fluid pathway between the inflation port and an inflatable balloon on the distal end of the catheter. As desired, the clinician may move the sealer portion to a position distal of the inflation port, thereby preventing any fluid from being introduced into or withdrawn from the balloon via the inflation port.

Description

CA 022~6401 1998-11-20 W 097/44085 PCT~USg7/08469 LOW PROFIIE CATHETER VA~VE
B7-kl. . ' of the Invention The present invention generally relates to catheters, and in particular, to a low profile catheter valve which may be opened to permit inflation or deflation of a catheter balloon, such as an occlusion balloon, and which may be closed when it is desirable to maintain the catheter balloon in an inflated state.
C' ~ ~ GS are ccr,.~ Iy used to guide the insertion of various medical ;"sl,l ,Is, such as catheters, to a desired treatment location within a patient's vas: ': G. In a typical procedure, the clinician forms an access point for the guidewire by creating an opening in a peripheral blood vessel, such as the femoral artery. The highly flexible guidewire is then i.,~ ed through the opening into the peripheral blood vessel, and is then advanced by 10 the clinician through the patient's blood vessels until the guidewire extends across the vessel segment to be treated.
Various l,eai l catheters, such as a balloon dilatation catheter for a percutaneous 11 ' -' coronary angioplasty, may then be inserted over the guidewire and similarly advanced through vas ' tL~G until they reach the ~"e"l site.
In certain llGallllGIII pl~r ' ~GS~ it is desirable to successNdly introduce and then remove a number of 15 different l~eai r.t catheters over a guidewire that has been placed in a particular location. In other words, one tlGdi I catheter is "fXC' le"' for another over a single guidewire. Such an exchange typically involves withdrawing the l,Gai I catheter over the guidewire until the treatment catheter is fully removed from the patient and the portion of the guidewire which extends from the patient. The guidewire is then available to act as a guide for a different treatment catheter.
In emboli containment devices, which typically utilize two occlusion balloons to form a chamber, it may be desirable to exchange Ihcr~ r~ catheters without deflating the occlusion balloons. Further, it is s.""~i -~IdV..ld9EGL~ to anchor the guidewire during the exchange. As can be readily ~, Gc;aled, the withdrawal of treatment catheters over a placed guidewire may result in the guidewire being displaced from its position. To overcome this difficulty, the prior art has developed "ar~rDr~ r'e" l l~.;IGS, which generally feature some structure on their distal ends to releasably secure the guidewire at a particular location in the patient for the duration of the medical ~r.c- ' G. One such anrr '' guidewire is disclosed in U.S. Patent No. 5,167,239 to Cohen et al., which discloses a hollow guidewire with an inflation lumen and an eA~. ' '' balloon on its end. The Cohen guidewire is pos;i lred in the same manner as a ~ ~G.,i lndl wire guidewire, but once placed, its eA~all~c''~ balloon is inflated to contact the surrounding vas 1 re, thereby r e~ ll9 the guidewire from being displaced.
Because a F 1 - 1l t inflation manifold, of the type used with cr ~G.~Iional catheters having an inflatable balloon, would prevent other catheters from being inserted over the Cohen guidewire, the Cohen device also includes a \e",o~ inflation manifold, and a check valve to maintain the balloon in the inflated state when the manifold is removed. The check valve apparatus used by the Cohen device is relatively bulky, and is described as having an outer diameter in its preferred embodiment of 0.0355 inches. Con.eq .lly, any t~Gal"~G"I catheter intended to be inserted over the Cohen device must have an interior guidewire lumen larger than the outer diameter of the Cohen valve, which for the preferred embodiment, requires an interior lumen with a diameter of more than 0.0355 inches.

~, . .. . .

CA 022~6401 1998-11-20 W O 97/44085 rCT/US97/08469 As is readily a" r~"alud by those of skill in the art, increasing the interior lumen size of a lleai catheter results in an increase in the outer diameter of the l~Gal",2nl catheter. For l~ca~ .l pl~c ' cs which take place in ~, s ' Il"e having a large blood vessel diameter, such as iliac arteries, a l,Gàl",~..l catheter guidewire lumen of a size ces-a y to acr d te devices such as those described by Cohen would have little or no affect on the ability of the catheter to fit within the blood vessel. However, many blood vessels where it is desirable to apply catheter Ireai I are quite narrow. For example, the left coronary arteries are blood vessels having diameters ranging from 2 to 4 mm, and are s-~se,: ' I to plaque. It would be desirable to use a catheter exchange llc-all".,.,l p .ce ' G, such as ~, F' -Iy, to treat such lesions, but the narrow diameter of the coronary vessels makes use of ar ~ --.q1l 9 ' ~ GS having large valve diameters impractical.
tO C~as~, Itl~, there exists a need for a very low profile catheter valve which can be used with a hollow guidewire.
Summarv of the Invention The present invention provides a catheter valve which is capable of very low profiles, and is especially advantageous for use with ~ ~bc ~ 9ll ' ~ s, as well as Ih~.i1; lh, or occlusion devices. By ;"~u",~"aliu3 the 15 valve of the present invention into such devices, it is possible to ~aLl~ c - bGi_'' y~ ' ;ltS and occlusion device catheters with outer diameters of 0.014 inches or smaller. Ad~,a"tage . 'y, by utilizing the present invention in these catheters, clinicians will be able to use arr'-~ , 'e. ;ltS, i' e pr l;C or occlusion device catheters in much narrower blood vessels than in the past.
In one aspect of the present invention, there is provided a valve which ccr,,,ul;aes a flexible elongate tubular body having a proximal end and a distal end. The tubular body has a central lumen extending between the proximal and distal ends. The central lumen has an opening at the proximal end.
An eYpP l'?q1l member, such as an inflatable balloon, is pc~;tiun~d on the distal end of the tubular body.
The ex~ '-'' member is in fluid r ei n with the central lumen. An access opening is provided on the tubular body. The access opening is in fluid r ri - with the central lumen to permit the ex~.ânti,b!~ member to be actuated by prts~uli~;"g the access opening.
A sealing member is provided having a sealer portion which seals against a surface of the tubular body.
The sealing portion of the sealing member is movable relative to said surface of the tubular body between two positions. In the first position, the sealer portion is pr --d in contact with the tubular body surface at a location which blocks the flow of fluid to or from the ~-r- ~ 1 l member through the access opening to maintain actuation of the ex~,an'1r'' member. In the second position, the sealer portion is p~: n~d at a location which permits the flow of fluid to or from the e re ~_~1 member through the access opening to permit actuation or deactuation of the ex,~e r ' 'I member.
In one preferred el bc' I, the sealing member has a portion which extends from the proximal end of the tubular body, and the arr' I - of a 1tn~, ' ' force on the extending portion results in Illu~lc.ll~ of the sealer portion in the direction of the applied force. In other .,.a'JC~ s, rotational forces may be used to move the sealing member.

, .... ..

CA 022~6401 1998-11-20 W 097/44085 PCT~US97/08469 The sealer portion is preferably formed of a polymeric material, such as Pebax, silicone, C-Flex(TM) or gels.
The sealer portion should be capable of ~.ith~i ~n 'i g balloon inflation pressures and prevent b~ i 'Iy all fluid from passing to or from the e~lpr n d " member through the access opening when the sealer portion is pc: nnd distal to the access opening. Adv~,,teOe~: 'y, the outer diameter of the tubular body is generally larger than 5 the outer diameter of any portion of the sealing member or sealer portion. In some bL ' l~n~S, the outer diameter of the tubular body is no greater than 0.038 inches, p,~fe, hly no greater than 0.020 inches, and more p,~.dLly no greater than 0.014 inches. Other c., bc' Is may have larger outer diameters for the tubular body. The tubular body may also have positive stops to prevent withdrawal of the sealing member from the opening.
In another aspect of the present invention, there is provided an a, p, atus, Cul,l"li ., a hollow metallic 10 guidewire having a central lumen and a 'e access port in fluid con. . -t r with the lumen. An inflatable balloon is mounted on the guidewire, the inflatable balloon being in fluid cu,,lll.. ~li.lr, with the central lumen, such that fluid introduced through the s;d~ e~c~ss port can be used to inflate the balloon.
A valve is mounted to slide along a surface of the guidewire, the valve movable between first and second positions, one of the positions sealing the central lumen such that subsl ti, 'Iy no fluid may pass to or from the inflatable balloon by way of the side ?cce~ port.
rlef~ , the hollow guidewire has an outer L;l '~.Lr.ce defining a first value, and wherein the movable valve has a chLulll~ llce which is less than the first value. It is also preferred that the hollow guidewire have an outer circ~ ,., -e of 0.12 inches or less, more p.~ 0.08 inches or less, and optimally 0.044 inches or less, and that the movable valve have a diameter not substantially larger than that of the hollow guidewire.
In another aspect of the present invention there is provided a low profile catheter valve which comprises a sealing member capable of being movably inserted through a proximal opening on a catheter into an inflation lumen of the catheter. The catheter has a ' access inflation port and an inflatable balloon in fluid ce~ tion with the '- ~rce~s inflation port. A sealer portion is on the sealing member, the sealer portion being capable of forming a fluid tight seal with the entire circumference of a section of the lumen, such that ~ all fluid may not pass the sealer portion at normal balloon inflation pressures.
When the sealer portion is p~s nfd within the lumen p.~ of the s;dE access inflation port, an "~tli-,lLd fluid pathway is ES~ d between the ;;' access inflation port and the balloori. When the sealer portion is po: -Pd within the lumen distally of the ~ ? ?Ccess inflation port, b.ldlll 'Iy all fluid may not pass to or from the balloon through the 1f 1rcess inflation port at normal balloon inflation pressures.
In another aspect of the present invention, there is provided a method of inflating a catheter balloon. The first step of the method involves providing a tube having a proximal end and a distal end. The proximal end of the tube has an inflation opening to an inflation lumen and the distal end has an inflatable balloon in fluid CGII. I . Iiùn with the inflation lumen. A p~Gr i.~d inflation fluid is then l~. 1u:sd through the inflation opening to inflate the balloon. The inflation opening may then be sealed by moving a sealing member within the inflation lumen without reducing the pressure of the p~6ssli,i.0d fluid, wherein the step of sealing is p~ llllEd without ~,.Sslanli~l deflation CA 022~6401 1998-11-20 W 097/44085 PCT~US97/08469 of the inflated balloon. Finally, the pressure of the ".t~ d fluid may be reduced after completing the sealing step.
In another aspect of the present invention, there is provided a low profile catheter valve for use with an inflation adaptor. The valve comprises a sealing member capable of being movably inserted through a proximal 5 opening on a catheter into an inflation lumen of the catheter. The catheter has an inflation opening and an inflatable balloon in fluid coml ~ Etiun with the inflation opening. Indicia are present on the catheter andlor sealing member, the position of the indicia being such that the inflation opening is aligned with a fluid tight inflation chamber of the inflation adaptor when the catheter and sealing member are secured in the inflation adaptor.
A sealer portion is mounted on the sealing member. The sealer portion is capable of forming a fluid tight 10 seal with the entire c;,~ rr of a section of the lumen, such that substantially all fluid may not pass the sealer portion at normal balloon inflation pressures. When the sealer portion is pc~ of the inflation opening, an t~lriLtbd fluid pathway is e~i "' ' d between the infiation opening and the balloon. When the sealer portion is pcs'lionEd distally of the inflation opening, - ' ~ , all fluid may not pass to or from the balloon through the ~;de ~cress inflation port.
In another aspect of the present invention, there is provided an inflation adaptor for ;"I,~c',.. ,;"a inflation fluid into an inflation port of an elongate tube. The inflation adaptor c....p~i~.;s a housing having first and second portions which interact to l~'~ "y retain a section of the tube therein. The housing has a chamber which receives the inflation port. An inflation inlet c .lfiy~l~d to be cc .q~tEd to a source of inflation fluid that supplies said fluid under pressure is p '~i~acd on the housing. A seal which releasably seals the portions of said housing together 20 provides a fluid pathway between the inflation inlet and the inflation port, so that fluid may be supplied to the inflation port under pressure. An actuator, mounted on said housing, drives a member within the tube to control fluid flow through said inflation port.
In another aspect of the present invention, there is provided an inflation adaptor for ;,.lr -h ', inflation fluid into an inflation port of an elongate tube. The inflation adaptor co",~ a housing having first and second 25 portions. The two portions form a mouth for receiving a section of the tube which includes the inflation port. The mouth forms an opening having a height at least as great as the outer diameter of the tube such that the section of tube is i ~ i " into the mouth from its side in a direction 11 ~,c.~e to the longitudinal axis of the tube. The housing also has an inflation chamber and an inflation inlet for ' :,.' ' ,9 inflation fluid under pressure into the inflation chamber. The inflation chamber ~ ,asably seals the inflation port to the inflation inlet to form a fluid 30 passage there between.
In another aspect of the present invention, there is provided an inflation adaptor for ;nll, h ,9 inflation fluid into an inflation port of an elongate tube. The tube has an inflatable member mounted thereon and an inflation lumen between the inflation port and the inflatable member. The adaptor has a housing cGr,(i~, ed to seal over the tubular body to create a fluid tight seal. An inflation inlet is on the housing, for e~l ''' I' ., a fluid pathway 35 between the inflation inlet and the inflation port to permit the inflatable member to be inflated. The housing is detachable from the tube without deflating the inflated inflatable member.

CA 022~6401 1998-11-20 W 097/44085 PCT~US97/08469 ~5-Brief D~.J~j. of the Drawinqs Figure 1 is a side view of a catheter CD ~Qrd~ 9 the low profile valve ot the present invention.
Figure 2 is an enlarged view of the proximal portion of the catheter of Figure 1, showing an exterior view of the catheter segment featuring the low profile valve of the present invention.
Figure 3A is a longitudinal cross-sectional view of the catheter segment of Figure 2, showing the low profile valve in the open position.
~ Figure 3B is a longitudinal cross sectional view of the catheter segment of Figure 2, showing the low profile valve in the closed position.
Figure 4 is a '~ ' cross sectional view of an all~."~ embodiment, showing the low profile valve in the closed position.
Figure 5 is a longitudinal cross sectional view of the embodiment of Figure 4, showing the low profile valve in the open position.
Figure 6 is a longitudinal cross-sectional view of an alternative ql bc' .gr: of the low profile valve, depicting the valve in the open position Fiyure 7 is a longitudinal cross sectional view of the embodiment of Figure ~, depicting the valve in the closed position.
Figure 8 is a p."~ ;.E view of an inflation adapter used to -, ' l~ the low profile valve of the present invention.
Figure 9A is a p~l~pCG~ view of the interior of the inflation adapter of Figure 8.
Figure 9B is a pErs~.ecli.~ view of a catheter with a sealing member and alignment indicia being positioned in the inflation adaptor of Figure 9A.
Figure 10 is an end view of an r' lldt;.., embodiment of the inflation adaptor.
Figure 11 is a cross sectional view of the inflation adaptor of Figure 10 along lines 10 10.
Figures 12 and 13 are exploded views of 't llnli.~. embodiments of the low profile valve of the present invention.
Figure 14 is an a~ dli.~ ~ bc ' l of the valve of the present invention featuring a built in spring bias.
Figure 15A and 15B are lurs ' ~' crosssectional views of the catheter proximal end of Figure 14, showing the valve in the closed and open position, I~ cO.~!r.
Detailed Des~,i. ti~ of the Preferred Embodiment Referring to Figure 1, there is depicted a catheter lO illCGl~Q di- 9 the low profile valve of the present invention. Although illustrated in the context of a simple occlusion balloon catheter, having a single inflation lumen and a single inflatable balloon, it is to be understood that the low profile valve of the present invention can be readily adapted to a wide variety of balloon catheters, including those having additional functionalities, ~Iru~l es, or intended uses. For example, the low profile valve could be easily adapted to catheters having expandable members other than occlusion balloons, such as i' dpe.,li~ dilatation balloons. r; ihe ",or~, the low profile valve of the . .. . . ... . . .. .. .. .

CA 022~6401 1998-11-20 W 097/4408~ PCTIUS97/08469 present invention may also be o ~,c, dlLd into catheters having two or more lumens. The manner of adapting the low profile vaive of the present invention to catheters having these various functionalities, s~ 5, or intended uses will become readily apparent to those of skill in the art in view of the desc,i~,liu., which follows.
Catheter 10 generally comprises an elongate flexible tubular body 18 extending between a proximal control end 12 and a distal ~ i e' end 14. Tubular body 18 has a central lumen 40 which extends between ends 12 and 14. Lumen 40 has an opening 23 at proximal end 12, and is sealed fluid tight at distal end 14. The length of tubular body 18 may be varied ro- ' "y ', ~ ., upon the desired 3p,'il :iun. For example, where catheter 10 is to be used as a guidewire for other catheters in a ce ~c..i ' F ~ transluminal coronary angioplasty , ,ce' ~ involving femoral artery access, lengths of tubular body 18 in the range of from about 120 to about 300 10 ce,.l I~.s are preferred, with a length of about 180 centimeters often being used. A~ lall.ly, for a different ll~dilllcnl r ~ca;l e, not requiring as long a length of tubular body 18, shorter lengths of tubular body 18 may be provided.
Typically, tubular body 18 will have a generally circular cross-sectional con~iyuldi n with an outer diameter within the range of from about 0.010 inches to 0.044 inches. Optimally, in most ~rl liOils where catheter 10 is to be used as a guidewire for other catheters, the outer diameter of tubular body 18 ranges from 0.010 inches to 0.038 inches, and r'e~ y iS 0.020 inches in diameter or smaller, more r ~fc,aLly 0.014 inches in outer diameter or smaller. The diameter of lumen 40 will be dictated, in part, by the outside diameter of tubular body 18.
For example, where tubular body 18 has an outer diameter of O.û14 inches, central lumen 40 may have an inner diameter of from about 0.008 inches to about 0.010 inches. The diameter of lumen 40 should be large enough to 20 ;..cG"ucral~ the low profile valve described below, and large enough to permit sufficient fluid passage for balloon inflation.
Nonc;,, I; cross-sectional c ~iyuldi 1lS of lumen 40 can also be adapted for use with the low profile valve of the present invention. For example, triangular IC~ oval, and other nûn";,~ ' cross-sectional ccn~iy.l,dliuns are also easily i - ~Drdl2d for use with present invention, as will be ap~ .c;al~.d by those of skill 25 in the art. The manner of adapting the valve of the present invention will become readily apparent in view of the -r j~i .. which follows.
In the preferred embodiment, the tubular body 18 functions as a guidewire, and thus, tubular body 18 must have sufficient structural integrity, or "pushability," to permit catheter 10 to be advanced through ~,as".lldl~.,e to distal arterial locations without buckling or undesirable bending of tubular body 18. It is also desirable for tubular 30 body 18 to have the ability to transmit torque, such as in those embodiments where it may be desirable to rotate tubular body 18 after insertion into a patient. A variety of b. - ,pci " materials, known by those of skill in the art to possess these ,ul.F Od5 and to be suitable for catheter manufacture, may be used to fashion tubular body 18. For example, tubular body 18 may be made of stainless steel, or may be made of polymeric materials such as nylon, polya", ' polyimide, pcl~e~hyl~ s, or ee b; I - thereof. In one preferred ~...bcl ,I, the desired 35 p,~Fe li~s of structural integrity and torque llallv" . are achieved by forming tubular body 18 out of an alloy of titanium and nickel, commonly referred to as nitinol. In a more preferred e bc ' ll~nl, the nitinol alloy used to CA 022~6401 1998-11-20 WO 97/4408S PCT~US97/08469 form tubular body 18 is CG~ d of about 50.8% nickel and the balance titanium, which is sold under the trade name Tinel (TM) by Memry Corp. It has been found that a catheter tubular body having this cr,"."ce:: . of nickel and titanium exhibits great flexibility and improved kink ~es,~lance in comparison to other materials.
The distal end 14 of catheter 10 is provided with an dlr lic distal tip 16, and an inflatable balloon 20, 5 as " :laldd in Figure 1. Inflatable balloon 20 may be made from any of a variety of materials known by those of skill in the art to be suitable for balloon ,,,a.,ufaci ~. For example, inflatable balloon 20 may be formed of rnaterials having a compliant expansion profile, such as F '~GIhj; or latex. In one preferred embodiment, where inflatable balloon 20 is to be used as an occlusion balloon, it is r.l ~ l 3~ formed of a block repol~",~, of styrene-ethylene-butylene styrene ISEBS), sold under the trade name C Flex ITM). Alternately, in those emb~ d ,.a"ts where 10 inflatable balloon 20 is to serve as a dilatation balloon, it may be formed of materials having a noncompliant e,~p, - r profile, such as F~eth~ rl Ihalale. Inflatable balloon 20 may be attached to tubular body 18 in any manner known to those of skill in the art, such as heat bonding or through use of adhesives.
As shown in Figure 1, catheter 10 is provided with a s ' acress inflation port or opening 22 formed in tubular body 18 at a point several ce.,i IO,~ distal from opening 23. Inflation port 22 is in fluid c liun with central lumen 40 extending through tubular body 18. A fill hole (not shown) is formed in tubular body 18 within the region enclosed by inflatable balloon 20, such that fluid passing through inflation port 22 and into lumen 40 may inflate balloon 20. C! I~ ,'y, an inflated balloon 20 can be deflated by withdrawal of fluid from balloon 20, through lumen 40, and out of s ' access inflation port 22.
The low profile valve of the present invention may be used with catheters such as that described above, 20 all well as with different catheters having different ~ t ~s. In one preferred - bo~' "~r,l, the low profile valve pr,~es a sealing member which is movably po ~;:ned within the inner lumen of a catheter. The catheter has an inflation port, which, in some ' t' ls,is also an opening to the inner lumen at the proximal end of the catheter.
An inflatable balloon is pû ~iLee~l on the distal end of the catheter, which is in fluid communication with the lumen and inflation port. The sealing member is inserted through the proximal opening into the lumen, with a portion of 25 the sealing member extending c~t~.al '1y from the proximal end of the catheter. The portion of the sealing member inserted into the lumen has a sealer portion which forms a fluid tight seal with the inner lumen to prevent fluid from passing past the sealer portion.
By prl etion of a pushing or pulling force on the extending sealing member portion, the sealing member may be partially advanced within or w; ' ' a.... from the lumen, thereby moving the sealer portion within the lumen.
30 In this manner, the sealer portion may be p--i .,ed within the lumen either proximally or distally of the inflation port. When the sealer portion is pQ i 'd proximally of the port, the valve is in the "open" position. When the valve is open, an u",~sl,i..led fluid pathway is est-~' ' d between the inflation port and the balloon, such that an external, ~s~u,i.ed fluid source may be co, - LLd to the inflation port to inflate the balloon, or if the balloon is ~ already inflated, the balloon may be deflated by ap, ' : of a vacuum to the inflation port to withdraw fluid from 35 the balloon. When the sealer portion is pc- - ' distally of the inflation port, the valve is in the closed position, as the fluid tight seal between the lumen and the sealer portion prevents fluid from passing either to or from the CA 022~6401 1998-11-20 W 097/44085 PCTrUS97/08469 balloon through the inflation port. ru, D~ lGr~, when the valve is closed after balloon inflation, the fluid tight seal created by the sealer portion maintains the balloon in the inflated state in the absence of an external fluid source, by plt~..,.i " the ,Gr-s iL..d fluid within the balloon from escaping.
Referring to Figures 2, 3A and 3B, there is depicted one embodiment of the low profile valve of the present 5 invention, as used with the catheter of Figure 1. Catheter 10, as described above, has a side access inflation port 22 which is in fluid CGIIl i r with central lumen 40, and through which fluid may be ;"Ir~,d~ced to inflate balloon 20. Central lumen 40 has an opening 23 at proximal end 12. A sealing member 30 is inserted into lumen 40 through opening 23. Sealing member 30 may be partially advanced within or ~.ilhdl..~." from lumen 40 by the , r'ic, i :1 of a ' nS: ' -' force on sealing member 30 directed toward or away from proximal end 12, ~tspL.,li~aly.
Sealing member 30 comprises a main shaft 33, a tapering region 31, and a wire 32. Sealing member 30 may be formed as solid piece out of suitable metals, such as stainless steel, nitinol and the like. For example, sealing member 30 may be formed as a solid cylindrical piece, and then be coined down at points along its length to form tapering region 31 and wire 32. Alternately, one or more of the main shaft 33, tapering region 31, or wire 32 may be formed , a dtcly, and then attached to the other piecels) by c~ nal means, such as soldering, to 15 form sealing member 30. Polymeric materials, such as Delron (TM), nylon, and the like, may also be used to form sealing member 30, either as a solid piece, or as separate pieces which are later joined to form the sealing member.
Although not required, in one preferred embodiment, main shaft 33 has an outer diameter no larger than the outer diameter of the catheter tubular body 18. Thus, if the outer diameter of tubular body 18 is 0.014 inches, the diameter of main shaft 33, and thus the largest diameter of sealing member 30, is no larger than 0.014 inches.
20 Fl"Il,~,l"or~, it is also preferred that main shaft 33 extend proximally from opening 23 by a distance of at least several c~"i : ~ to facilitate the 3"' - :.. of longitudinal forces on main shaft 33 to ",arl, ' Ie the position of wire 32 in lumen 40. Moreover, after catheter 10 has been fully inserted into a patient, an extending main shaft 33 adv~nta ,Pcc 1y functions much like a cDrn,an~ional guidewire ~li r, providing a starting point for the clinician to insert other catheters over main shaft 33 and catheter 10.
The combined length of catheter 10 and extending main shaft 33 may be varied cor,s;de,ably at the point of ~'acl~Jre, and may be adapted to the ,,gu 1,...~ of the other catheters which are to be used with catheter 10 and main shaft 33. For example, where catheter 10 is to be used as a guidewire for other catheters in an "over-the wire" embodiment, it is preferred that the total length of catheter 10 with extending main shaft 33 be about 300 ce..Ii". I~r~. Alternately, when catheter 10 is to be used as a guidewire for other catheters in a single operator embodiment, or "RAPID-EXCHANGE" embodiment, it is preferred that the total length of catheter 10 with extending main shaft 33 be about 180 centimeters. As can be readily,, ec;dl~d, the individual lengths of catheter 10 and extending main shaft 33 can be varied con~;d~ and yet still achieve the overall desired combined length. For example, a catheter 10 having a length of 180 CL~ can be provided with an extending main shaft 33 having a length of 120 centimeters, to achieve the 300 CL.II 1~11., total desired length for over the wire ~ bc~ "Is.
In another embodiment, where it is . ~l dL!~ to have a long main shaft extending proximally from catheter 10, a main shaft extending proximally only several c~lll I.,.a may be provided. The shorter main shaft may be CA 022~6401 1998-11-20 W 097/44085 PCT~US97/08469 provided with an ~llarh",a,~I ~not shownl, which is adapted to releasably secure ionger e.~ r- tO the main shaft, such that it can also be used to facilitate the use of catheter 10 as a guidewire for other catheters.
It is preferred that main shaft 33 have a larger diameter than the other portions of sealing member 30, to make it easier to apply moving forces to sealing member 30. Thus, a tapering region 31 may be disposed between main shaft 33 and wire 32, to transition the outer diameter of sealing member 30 from the larger diameter of main shaft 33 to the smaller diameter of wire 32. For the embodiment illustrated in Figures 1-3, it is wire 32 which is slidably inserted through opening 23 and into lumen 40. ACCGId .~,'y, the outer diameter of wire 32 must be less than the inner diameter of lumen 40, so that wire 32 may be slidably accrm ~dalcd therein. Moreover, in those embDd ll~nls where the end of wire 32 extends distally past inflation port 22 when the valve is in the open 10 position, the gap between the outer diameter of wire 32 and the inner diameter of lumen 40 must be suf~ic;c.~lv large so as not to significantly restrict the flow of fluid passing through lumen 40 to or from inflation port 22.
Optimally, to facilitate the sliding of wire 32 within lumen 40 and to permit inflation fluid flow, wire 32 is from about O.OOl inches to about 0.004 inches smaller in outer diameter than the inner diameter of lumen 40.
In a preferred ~l bc-' I, wire 32 and catheter 10 are provided with positive stops to prevent the 15 withdrawal of wire 32 from the proximal end of catheter 10. For the embodiment depicted in Figures 3A and 3B, this consists of a pair of cooperating annular rings mounted on wire 32 and lumen 40, respoclivcly. A first annular ring 34 is coaxially and fixedly mounted on wire 32 at a point on wire 32 contained within lumen 40. A second cu.,. ,o ' g fixed annular ring 35 projects inwardly from the interior surface of lumen 40 near proximal end 12.
The inner diameter of the opening of annular lumen ring 35 is slightly larger than the outer diameter of wire 32, so 20 as not to restrict the ll ~c I of wire 32 within lumen 40. However, the outer diameter of annular wire ring 34 is greater than the inner diameter of the opening of ring 35, such that rings 34 and 35 coope~dIe to prevent wire 32 from being ~.;lhd~oL.~ from the proximal end of catheter 10.
Rings 34 and 35 may be formed of any material which may be attached to wire 32 and lumen 40, ,~ pncli.dly, and which ros.,r ~ sufficient structural rigidity to act as a stop. Examples of suitable materials are 25 metals and various hard polymers, such as stainless steel and Teflon (TM). In one preferred e.l,b- ' ~nl, where wire 32 and tubular body 18 are both formed of nitinol, rings 34 and 35 are also formed of nitinol and are soldered to wire 32 and the inner surface of lumen 40, ~ al~.
As will be a~lucial~d by those of skill in the art, coDpr alillg stopping ~lluctlllcs other than those described herein may also be used to prevent full .. ' Ir..~.al of wire 32 from catheter 10. For example, annular 30 ring 34 may be replaced by one or more plullu~;ol~ extending radially out~aldly from wire 32, which are also adapted to coDpr dle with ring 35 to prevent ~.ithdl.~. al of wire 32. Alternately, annular ring 35 might be replaced by crimping tubular body 18 slightly to restrict I ~vr of ring 34 to points proximal of the crimp.
A lumen sealer portion 36 is coaxially and fixedly mounted on wire 32. Sealer portion 36 is pos;lioned on wire 32 at a point distal to ring 34, such that by partial ~ itl.' u,~al of wire 32 from catheter 10, as depicted in Figure 3A, sealer portion 36 is capable of being Fn Ired within lumen 40 at a point proximal to inflation port 22. Sealer portion 36 is also located on wire 32 at a point such that when wire 32 is fully inserted into lumen 40, ...... . . . ... ..... ... ...

CA 022~6401 1998-11-20 as depicted in Figure 3B, sealer portion 36 either fully covers inflation port 22, or is located within lumen 40 at a point distal to inflation port 22. The leading edge 36a and trailing edge 36b of sealer portion 36 are I ~ hl~
tapered, so that the edges of sealer portion 36 do not catch upon inflation port 22 when sealer portion 36 passes by port 22.
It is preferred that sealer portion 36 form a fluid tight seal with the outer diameter of wire 32 and the inner diameter of lumen 40, such that fluid in lumen 40is prevented from flowing past sealer portion 36. In the r bc" I illustrated in Figures 3A and 3B, this is achieved by providing wire 32 with a sealer portion 36 that firmly contacts the entire inner ci~ ~e.l ee of a section of lumen 40 along a substantial portion of the length of sealer portion 36. The fit between the outer surface of sealer portion 36 and the inner surface of lumen 40is tight, 10 such that a fluid tight seal is created which prevents fluid from passing past sealer portion 36. However, sealer portion 36 must be capable of being moved within lumen 40 upon I ~... t of main shaft 33, tapering region 31, and wire 32. Thus, the fit between sealer portion 36 and lumen 40 must not be so tight as to prevent -v .. I
of sealer portion 36 in lumen 40 upon 1"2 )r of sufficient longitudinal force on main shaft 33. Moreover, the fluid tight seal created by the fit between lumen 40 and sealer portion 36 must be - i ~ as sealer portion 36 15 is moved back and forth within lumen 40.
Sealer portion 36 must also be capable of i , 9 a seal at fluid pressures ~ ai -'Iy used to inflate catheter balloons, and should be capable of ",-; ~ a seal at pressures which exceed c ~ nal inflation pressures. P~ ,dbly, sealer portion 36 is capable of ... i- 9 a seal at pressures up to about 10 dtl..-s, ' ~, more pr~f~,ably pressures up to about 30 d~ i, h~ , and most ~"~le, "y at pressures up to about 6û
20 ai -, '-- ~s. Sealer portion 36 is also p,~l~. hlV capable of undergoing multiple ve!~e eFe 19 and valve closing cycles without losing the structural integrity required to form seals capable of withstanding pressures of from about 10 alu,o~he,es to about 60 at ~S,:b~:lb,~. Optimally, sealer portion 36 is capable of ' yc: 9 at least 10, and ",~lel 'My at least 20, va!ve e~ .9 and closing events and still be capable of ...- ,i 9 a fluid tight seal at a pressure of 10 al" ~, he ~s.
In one preferred embodiment, the desired, , li~s of sealer portion 36 are attained by forming sealer portion 36 out of an extruded polymeric tubing. Pebax ITM~ tubing having an inner diameter of O.OOB inches and an outer diameter of 0.017 inches, and a hardness of 40 durometers, is first necked by heating the extruded tubing to a t , ~ dluie of between 210 and 250 degrees Fahrenheit. Tube pieces of about 0.5 mm in length are then cut from the larger tubing. The cut Pebax ITMI tubes are then placed on a nitinol wire having an outer diameter of about 0.006 inches, and are heated and shaped to recover a tube that has an outer diameter of between 0.010 0.011 inches. The adhesive Loctite 4014 ITM) may then be used to bond the heat-shaped Pebax ITM) tubing to the nitinol wire. When the adhesive dries, the leading and trailing edges of the bound Pebax ITM) seal may be trimmed, leaving an annular lumen contact length of about 0.010 inches ~.25mm). The wire bearing the Pebax (TM) sealer portion may then be inserted into the opening of a nitinol catheter having a lumen with an inner diameter of about 0.0096 inches. Sealer portions of this type have been observed to hold pressures of up to 30 a~n.e ,:':e ~s, CA 022~6401 1998-11-20 .11.
and are capable of d- ~c: 19 multiple \, '~c apr .9 and closing events without s;y" 'i 0~ " . . ' 9 the seal strength.
It is contemplated by the present inventors that methods and materials other than those described above may be used to make a lumen sealer portion having the desired ~ , lies. For example, materials other than Pebax 5 ITM), silicone, latex rubber, C Flex (TM), Nusil ITM) and gels, which are known to possess adequate surface prere lics to function as a sealer portion, and also be lubricous enough to be moved within lumen 40, may also be used to form sealer portion 36. In addition, sealer portion 36 may be attached to wire 32 by alternate means, such as by integrally molding sealer portion 36 to wire 32, dip forming sealer portion 36 to wire 32, as well as other means of attaching a polymeric material to a wire known to those of skill in the art.
Other ~.nbcd Is of sealer portion may not create a completely fluid tight seal between the sealer portion and the inner lumen at balloon inflation pressures. In these embodiments, however, the sealer portion creates a seal which prevents substantially all inflation fluid flow past the sealer portion, such that the inflatable occlusive device is ~- ~ ~ ,Ed in an almost fully expanded state for extended periods of at least one minute, p ci~dbly 2 or more minutes, more p,~ y at least 10 minutes, and optimally at least 20 minutes or longer, and still be capable of providing clinically effective occlusion of any emboli particles in the blood vessel during this time period.
In a preferred embodiment, there is provided I ~c ~t force i"~.rcas;"g structure, to increase the force required to move sealer portion 36 from the valve-closed to the valvL o~ 1 position. Structure of this type advar,l;genusly minimizes the risk of an -- ' t~l opening of the valve, and ~.eq.,~!"l balloon deflation, during a medical procedure. In the e bc ' - t illustrated in Figures 3A and 3B, this achieved by providing a biasing spring 37, which surrounds wire 32 between stops 34 and 35. Spring 37 exerts a force on stop 34, pushing it, and thus wire 32 and sealer portion 36, in the distal direction, so that sealer portion 36 forms a fluid tight seal by either covering port 22 or by being pos,l' er' within the lumen at a point distal to port 22. Cc. -, Oy, in the absence of a c~.", Elillg force, spring 37 maintains sealer portion 36 in the valve closed position. Sealer portion 36 may be moved proximally to the ,ne.'.c ~FL. position by 3~ r of a ~t ~, ' ' force on main shaft 33 directed pr, -~y from end 12 of sufficient ! 19 ~- Ie to overcome the force of spring 37. Optimally, spring 37 is selected so that the force that must be applied to main shaft 33 to overcome the force of spring 37 is from about 0.3 to about 1.0 pound-foot. In alternative embodiments, the ." ~. .t force increasing structure may comprise waves b~lr~t'L ed into the wire just proximal of the sealer portion, as described below, which also may require 0.3 to 1.0 pound foot of force to overcome.
Referring to Figures 4 and 5, there is illustrated in alternative ~.,.bc:' - I of the valve of the present invention. The alte",alil~e L.l bod- ~t comprises a catheter 110 which may have features which are ' I.,.,i 'Iy identical, in materials, structure, and function, as the catheter described in c~ nect ~n with Figures 1-3. Catheter 110 has a proximal end 112, and a distal end (not shown) to which is mounted an eApal ~~" member, such as an inflatable balloon. A central lumen 140 extends within tubular body 118 between the proximal and distal ends. An opening 123 to lumen 140 is present at the proximal end 112 of catheter 110.

.. , ., ~ . .. .

CA 022~6401 1998-11-20 WO 97/4408~ PCTrUS97/08469 A sealing member 130 is inserted into lumen 140 through opening 1Z3, as described ,,.c~ . Sealing member 130 cc,~ ds a sealer portion 136, a wire 132, annular rings 134 and 135, and support member 150.
Sealing member 130 may be formed out of materials and by methods as described previously.
As illustrated in Figures 4 and 5, the outer diameter of wire 132 is less than the inner diameter of lumen 140, such that sealing member 130 is slidably insertable into lumen 140. Furthermore, a lumen sealer portion 136 is coaxially and fixedly mounted to wire 132 near the distal end of wire 132. Sealer portion 136 forms a fluid tight seal with the outer diameter of wire 132 and the inner diameter of lumen 140, such that fluid hlll~ dL. Jrl into lumen 140 through opening 122 is prevented from flowing past sealer portion 136 at normal balloon inflation pressures of 1 to 3 di ~, ' ~ ~a for occlusive devices, and as much at 10 al", sp~ bS or more for other types of balloons.
10 Sealer portion 136 may be provided with leading edge 136a and trailing edge 136b, both tapered, to facilitate ,n.,~ l of sealing portion 136 proximally and distally of inflation port 122. Sealer portion 136 forms a fluid tight seal by firming contacting the entire inner Ci,l,.".,f.~ sr of a section of lumen 140 along a j~L~Ialllidl portion of the length of sealer portion 136. As described previously, sealer portion 136 prevents i~JLsla"C 'Iy all fluid flow past the seal created by sealer portion 136, and the m~G..,~.,I of sealer portion 136 ~,o,d",-'ly and distally of port 15 122 may be used to effect the 1, l~.r and valve-closed positions.
Cor~e d~i..c positive stops, c~rs i ~ of hollow cylinders 134 and 135 are provided to prevent withdrawal of sealing member 130 from lumen 140. Hollow cylinder 135 is attached to the inner surface of lumen 140 by adhesives, soldering, crimping, or by other means known to those of skill in the art, such that the proximal portion of hollow cylinder 135 extends within lumen 140, and is secured therein, and the distal portion of cylinder 135 extends from proximal end 112. Cylinder 135 has a lumen Inot shown) extending ILt,~lh,.- v' The diameter of the cylinder lumen is larger than the outer diameter of wire 132, so that " r,r~ .,l of wire 132 is not restricted.
A second hollow cylinder 134, pr~f~,rably of shorter length, is placed over wire 132 and is fixedly mounted to wire 132, by soldering, or other means, at a point distal to cylinder 135. The outer diameter of cylinder 134 is less than the inner diameter of lumen 140, so as not to restrict the II.D~. I of wire 132 within lumen 140. However, the outer diameter of cylinder 134 is greater than the inner lumen diameter of cylinder 135, so that cylinders 134 and 135 act as ccLperal g stops, to prevent wire 132 from being . ' ' a~ from lumen 140. Cylinders 134 and 135 may be formed of any material which may be attached to wire 132 and lumen 140, l~s~.Ecli~.,!y, and which pDssesses sufficient structural rigidity to act as a stop. Examples of suitable materials are metals and various hard polymers, such as stainless steel, Teflon ITM), and the like. In one preferred ...bo', I, where wire 132 and tubular body 118 are both formed of nitinol, cylinders 134 and 135 are also formed of nitinol, and are soldered to wire 132 and the inner surface of lumen 140, r., e ~
The distal portion of cylinder 135 extending from proximal end 112 is inserted into support member 150.
Support member 150 comprises a tubular body 158 having an outer diameter and inner lumen diameter which are approximately the same as tubular body 118. Ccrse, :I~, because the outer diameter of cylinder 135 is less than the inner lumen diameter of support member 150, the extending portion of cylinder 135 is slidably disposed within the support member 150 inner lumen.

CA 022~6401 1998-11-20 WO 97/4408S PCT~US97/08469 ~13-Wire 132 extends proximally from cylinder 135 within support member 150, as shown in Figures 4 and 5.
A segment of wire 132 within support member 150is secured to support member 150 at point 152. Wire 132 may be secured to support member 150 by any means known to those of skill in the art, including use of adhesives, crimping, soldering or welding. Because wire 132is secured to support member 150, the ap~ of longitudinal forces on support member 150 results in a.c l of sealing member 130 within lumen 140, to open or close the valve of the present invention, as described above with respect to Figures 1-3. Adva"ld6col,~1y, use of support member 150 protects wire 132 from e!~ '' kinking or bending when sealing member 130is moved.
As illustrated in Figures 4 and 5, sealing member 130 has ,,,c.c e: force ;"I.,casi"g structure which increases the force required to move sealing member 130 within lumen 140. The ,,,u~,c.,.~,,lforce ;.,."ca~;"g 10 structure consists of waves 138 formed in wire 132 just proximal to sealer portion 136. Waves 138 contact the inner surface of lumen 140, thereby i - eas;"g the frictional forces which must be overcome to move wire 132 within lumen 140. In one preferred embodiment, where wire 132is made of nitinol and has an outer diameter of 0.006 inches, and is inserted into a nitinol catheter which has an inner lumen 140 with the diameter of about 0.010 inches, waves are formed on wire 132 for one and one-half cycles with an amplitude of about 0.016 inches to 15 increase the v '~c op 9 ",u.c I force.
Referring to Figures 6 and 7, there is illustrated another embodiment of the present invention. Referring to Figure 6, there is provided a catheter 400 having a tubular body 418 and inflatable balloon lnot shown) as described above. Catheter 400 may be formed of materials and methods as described above, and may have structural aspects identical to those described ~.;.3..~1y, except where otherwise noted. In particular, as shown 20 in Figures 6 and 7, catheter 400is not provided with a ic arcess port on the catheter tubular body, nor is there provided cLL,ce dOI.g positive stops on the wire and lumen. Instead, the sealer portion may be fully withdrawn from the lumen. Once the sealer portion is removed, the proximal opening serves as an access port for attached devices to inflate or deflate the balloon. The sealer portion can be inserted through the proximal opening into the lumen after balloon inflation to maintain the balloon in the inflated state.
Catheter 400 has a proximal end 412, and a distal end Inot shown) to which is mounted an inflatable balloon. A central lumen 440 extends within tubular body 418 between the proximal and distal ends. An opening 423 to lumen 440is present at the proximal end 412 of catheter 400.
A sealing member 430is inserted into lumen 440 through opening 423. Sealing member 430 has a main shaft 433, a tapering region 431, and a wire 432. Sealing member 430 may be formed of materials and by methods 30 as described p",~; - 'y. As illustrated in Figures 6 and 7, the outer diameter of main shaft 433is less than the inner diameter of lumen 440, such that main shaft 433is slidably insertable into lumen 440. In addition, the outer diameters of tapering region 431 and wire 432 are also smaller than main shaft 433, and thus lumen 440, such that tapering region 431 and wire 432 are also slidably insertable in lumen 440. A portion of main shaft 433 prcf~i;aLly extends proximally from end 412, to facilitate a,, 'it:3n of moving forces upon sealing member 430 to move wire 35 432 within lumen 440, as described previously.

CA 022~6401 1998-11-20 W097/44085 PCT~US97/08469 As illustrated in Figures 6 and 7, sealing member 430 has ~.,.. ,~"I-force hl~ structure which increases the force required to move sealing member 430 within lumen 440. The ".u~ l force c eas;"g structure consists of waves 438a and 438b formed in wire 432 near its distal end. Waves 438a and 438b contact the inner surface of lumen 440, thereby Gas;,,U the frictional force which must be overcome to move wire 432 within lumen 440. In one preferred embodiment, where wire 432 is made of nitinol and has an outer diameter of 0.006 inches, and is inserted into a nitinol catheter which has an inner lumen 440 with a diameter of about 0.010 inches, waves are formed on wire 432 for 1-112 cycles with an amplitude of about 0.016 inches to increase the v_l~e Dp~ G t force.
A lumen sealer portion 436 is coaxially and fixedly mounted on wire 432. Sealer portion 436 forms a fluid tight seal with the outer diameter of wire 432 and the inner diameter of lumen 440, such that fluid Ir.-'c ed into lumen 440 through opening 423 is prevented from flowing past sealer portion 436 when sealer portion 436 is inserted into lumen 440. Sealer portion 436 forms the fluid tight seal by firmly contacting the entire inner cill,LIlll[Grb ce of a section of lumen 440 along a - b l~"lidl portion of the length of sealer portion 436, and may be formed of materials and by methods as p.c~;oli~ly described.
In some l~i.llGv~ ' ' sealing member bod the sealing member is not provided with a separate sealing portion, as described above. In these embQ' .a,\ls, the sealing member itself functions as a sealing portion which is inserted into the proximal opening to restrict fluid flow, and which may be partially or wholly removed to provide for a fluid pathway between the proximal opening and an ..., ' ' I member on the distal end of the catheter.
Preferably, the sealing members of these emb-' ~nls comprise a tapering rod, which at its distal end, has an outer diameter smaller than the inner lumen diameter of the catheter in which it is inserted as a plug, such that the distal end of the rod may be easily inserted into the catheter lumen through the proximal opening. The tapering rod increases in outside diameter at points proximal to the distal end. Cc: , .lly, one or more points of the rod have an outside diameter greater than the inner lumen diameter of the catheter in which it is inserted as a plug, such that by forcing the rod into proximal opening, the larger outer diameter of the rod forms a relatively fluid tight seal with the catheter lumen at the proximal opening of the catheter. An 0-ring, or other polymeric structure, may be mounted in the inner lumen of the catheter at or near the proximal opening, to cooperate with the tapering rod in the creation of the seal. Thus, in this embodiment, the point where the seal is created does not move with respect to the catheter, but is instead stationary at or near the proximal opening of the catheter.
Referring to Figure 12, there is depicted an . ' lldli~., G~ bc.'- I of the valve the present invention. The alternative n bQ:' Il is provided to a catheter 500, formed of a tubular body 518 and having a proximal end 512.
Catheter 500 has an opening 523 at is proximal end, and a lumen 540 extending the length of the tubular body.
Lumen 540 is in fluid ~ , et with an e ,: ' ' ' member (not shown) mounted on the distal end of tubular body 518. A si.l~ access port 522 is provided in tubular body 518 at a point distal to proximal end 512. Catheter 500 may have aspects identical, both in structure, ' s, materials, and conal~-..,i , to catheters described 35 previously.

W O 97/44085 PCT~US97/08469 ~15-A sealing msmber 550ispo~ ~ d within lumen 540 near proximal opening 523 and side-access port 522.
Sealing member 550is formed from a short tubular body 568, having a lumen 590, which is sealed at end 562, but open at the other end. Sealing member 550 has an outer diameter slightly larger that the inner diameter of lumen 540, but smaller than the outer diameter of tubular body 518, such that sealing member 550 may be tightly fit within lumen 540 through opening 523, to form a fluid tight seal over catheter proximal opening 523. Ccop~ dt; ~, stopping structures (not shownl may be provided to sealing member 550 and catheter 500 to prevent removal of sealing member 550 from lumen 540 at elevated pressures. Sealing member 550 may be formed out of the same materials as tubular body 518.
Tubular body 568is provided with an opening 572 extending ih~ ~11". ah. Opening 572isp~~ ~ on 10 tubular body 568 such that opening 572is capable of aligning with le atcess port 522 when sealing member 550 is rotated within lumen 540, or is moved; m P~ly.or distally within lumen 540. A rotation element 595, such as a per~ ..d ' attachment, may be provided facilitate rotation of sealing member 550 within lumen 540. Other rotation elements, such as notches or grooves, may be used in place of the pErprrlr' '; r allacl""~"l, as will be apl"~cidlQd by those of skill in the art.
Sealing member 550 functions as a valve within catheter 500, c(",lr." " fluid flow through side-access port 522. When sealing member 550iS rotated so that port 522 and opening 572 are aligned, fluid may flow through port 522 through lumen 540 to inflate the occlusive device. Upon the desired inflation, sealing member 550 may be rotated, as for example by ninety degrees, or moved proximally or distally within lumen 540, such that opening 572is no longer aligned with port 522, and tubular body 568 blocks fluid flow through port 522.
Shown in Figure 13,is an alt~""ali~ embodiment of the rotatable sealing member. Numerals co"t~,onding to those of the e bc.'i~ l of Figure 12 have been used to illustrate the similar structural aspects between the two ...bc~ . Sealing member 600is identical in c~r :lucl Jr to the sealing member of Figure 12, except that sealing member 650iS somewhat larger, and is adapted to be slipped over tubular body 618 The r~s~.ecli.e diameters of tubular body 618 and sealing member lumen 690 are such that a fluid tight seal is created over lumen 623. Sidc ncces~ inflation port 622 may be aligned with opening 672, as above, by rotation or longitudinal ",o~",~,r,l, to provide fluid access to lumen 640 through port 622.
In certain embodiments, it may be desirable for sealing members 550 and 650 to have a'longer length, such that they may function as an extension for other catheters to be inserted over catheters 500 and 600. In these embodiments, sealing members 550 and 650 may be formed with longer tubular bodies, or be provided with alldcll l so that extension members may be releasably secured thereto.
Referring to Figures 14, 15A and 15B, there is illustrated an 3'l 1Id6~c ' bc:' .1l of the present invention featuring a self-closing valve. The -' lla6.e bc:' 1.,..l comprises a catheter 700 having an elongate flexible tubular body 718 extending between a proximal control end 712 and a distal f, Icl ~' end (not shownl, and having a balloon (not shownl as described previously. Tubular body 718 has central lumen 740 which extends between the proximal and distal ends. Lumen 740 has an opening 723 at proximal end 712, and is sealed fluid tight at the distal end. A side access inflation port 722is formed in tubular body 718 at a point distal of opening 723.

CA 022~6401 1998-11-20 ~16-lnflation port 722 and lumen 740 are in fluid col :ct with the distal inflatable balloon, as described A wire 732is inserted into opening 723, and is slidably disposed within lumen 740. Accord ~'y, the outer diameter of the wire 732 must be less than the inner diameter of lumen 740,so that wire 732 may be slidably accommodated therein. A sealer portion 736is coaxially mounted on wire 732. Sealer portion 736is of similar type and c~r ~ to the sealer portion described in ca. ~ I with Figures 1-3. Sealer portion 736ispo. ~d on wire 732 at a point distal to inflation port 722, and forms fluid-tight seal with the outer diameter of wire 732 and the inner diameter of lumen 740, such that fluid iull~ d into lumen 740ispl,.a,\1ed from flowing past sealer portion 736. Cor~r, :1y, because sealer portion 736ispc ,2d with lumen 740 distal to inflation port 722, 10 sealer portion 736is in the v '~ :' -e~ position.
In the embodiment depicted in Figures 14-15B, tubular body 718is formed from a material having a certain degree of elasticity, such that if the proximal end 712 of tubular body 71Bis secured to wire 732 at point 750, and a 'ans i ' -' force is applied to tubular body 718 in a direction distal to end 712, the elasticity of tubular body 718 results in the shifting of inflation port 722 in the distal direction. Moreover, slits 711 may be formed in tubular 15 body 718 nearproximalend 712 toenhancetheelasticresponseoftubularbody 718, thereby;"."~asi"ythedistal l,~.,slocation of inflation port 722 upon, r~il sl: 1 of an axial force to tubular body 718. Wire 732 may be secured to tubular body 718 by any means known to those of skill in the art, such as adhesives, welding, soldering, or crimping.
In a preferred embodiment, tubular body 718is made out of nitinol, and has at least 8% elasticity when 20 '~ ' slits 711 are i :,o~ at the proximal end. As can be observed in Figure 15A, in the absence of any longitudinal force applied to tubular body 718, sealer portion 736is pG~;~i,,.ed within lumen 740 at a point distal to inflation port 722, such that fluid may not pass through port 722 to inflate or deflate the balloon. However, if a ! ng It' -' force is applied to tubular body 718 in the distal direction, and the proximal end of tubular body 718 and wire 732 are held in position, tubular body will stretch, as shown in Figure 15B, and inflation port 722 will be 25 I~--'a ~id in the distal direction so that sealer portion 736 will be located within the lumen proximally of port 722.
This will establish an u ~IHLI~d fluid pathway between inflation port 722 and the distal balloon, so that the balloon may be either inflated or deflated by passage of fluid through port 722. Upon removal of the ' , -" -' force, the elastic response of tubular body 718 will result in proximal trar ' ~2tiun of inflation port 722, and sealer portion 736 will once again be in the valve closed position.
Referring to Figures 8 and 9A, there is illustrated an inflation adaptor 200 which may be used to inflate and to open and close the low profile valve depicted in Figures 1-5. Inflation adaptor 200 c~ es a housing having a first half 202 and a second half 204, which are I efu.~ bly formed of metal, medical grade polyca,L--- le, or the like. Halves 202 and 204 are attached to one another by a pair of hinges 205p- : ~ on one of the lateral edyes of each half, such that halves 202 and 204 may be separated or joined in a clam shell manner as depicted in Figures 8 and 9. A locking clip 230 secures half 202 to half 204 while inflation adaptor 200is in use.

CA 022~6401 1998-11-20 LoGking clip 230 may be provided with an angled leading edge 235 to facilitate closing of clip 230 to secure halves 202 and 204 together. Springs 209 may also be provided to facilitate opening of adaptor 200.
A groove 240 separates first half 202 from second half 204 when the halves are closed and clip 230 is secured. Groove 240 is of sufficient width to accept the proximal end of a catheter having the low profile valve of the present invention, as described in detail above. A fitting 210 is pa~ r -d on half 202, to create an inflation passase..dy 212 which tLr. les in opening 285 on the interior surface of first half 202. Fitting 210 is ~ . "y a standard luer ~ ctor which may be attached to a variety of existing external pre~ ..i."d fluid sources, although other types of fittings, such as tubings, quick connects, and Y site Ln, n~ s may be easily substituted for a luer fitting.
A seal comprising a pair of gaskets 280 is pcs: ~d around opening 285 on the interior surfaces of halves 202 and 204. Gaskets 280 are in alignment, such that when halves 202 and 204 are brought together and secured by locking clip 230, a fluid tight inflation chamber is created within the interior region defined by gaskets 280. The fluid tight inflation chamber is in fluid c ", al,on with fitting 210 via inflation passab.,~.a~ 212, so that a pr~ssu,i~d inflation fluid may be i"tr~dl ~sd into the fluid tight inflation chamber by attaching an external ~ d fluid source to fitting 210. Moreover, gaskets 280 are rr~L; "y formed of resilient materials, such as silicone, C-Flex ~TM) and Pebax ITM), so that gaskets 280 may form fit over a catheter tubular body which extends across the lateral edges of gaskets 280, to create the fluid tight chamber.
An actuator 220 is pc Pd on the external surface of half 202. In the embodiment " :rd~d in Figures 8 and 9, actuator 220 controls a cam which operates a sliding panel 283 on the interior surface of half 2Q2. Sliding panel 283 moves back and forth along a line which bisects opening 285. When actuator 220 is moved to a first position, sliding panel 283 moves toward opening 285 along this line. When actuator 220 is moved to a second position, sliding panel 283 moves away from opening 285 along the same line. A cGr,~ rD, ' ~ sliding panel 284 is pr i ~d on half 204, such that panels 283 and 284 are aligned and move together when the position of actuator 220 is changed. To facilitate c~rn' l.,d .. -I of panels 283 and 284, a pin 286, or such other similar engagement structure, may be provided to ,.,'easabl~ secure panel 283 to panel 284 when the adaptor is closed. The length of travel of panels 283 and 284 is I ~h.~ "~ adjusted to provide the minimum sufficient distance to position the sealing member in the valve open or valve closed position, as desired.
Panels 283 and 284 each have a ~Jl' ed surface 290, to facilitate the frictional engal, ~l of panels 283 and 284 with the main shaft portion of the low profile valve. In a preferred c., br " ,~.,I, panels 283 and 284 are both made of silicone, and roughened surface 290 comprises teeth 291 and grooves 292 formed on each of panels 283 and 284. The teeth 291 and grooves 292 c~ra~dle, to permit the teeth of one panel to fit into the grooves of the opposite panel when the adaptor is closed.
For ease of 'ESi ding, the operation of inflation adaptor 200 to inflate the balloon of the catheter of Figures 1-3 will now be described. Actuator 220 is moved to the first position, so that sliding panels 283 and 284 are moved closer to opening 285. Locking clip 230 is then undone, exposing groove 240. Halves 202 and 204 are then partially separated, and catheter 10, with the balloon 20 deflated, is inserted into the inflation adaptor. As ~ . . . .. .... ... . . . . .

CA 022~6401 1998-11-20 WO 97/44085 PCT~US97/08469 described p~e~ 'y, catheter 10 has an inflation port 22 located near proximal end 12, and a main shaft 33 extending from proximal end 12. Catheter 10, with the low profile valve in the closed position, is placed within groove 240 of partially open adaptor 200, and catheter 10 and main shaft 33 are placed within securing clips 271 and 272, such that when halves 202 and 204 are closed, inflation port 22 will lie within the fluid tight inflation chamber created by gaskets 280, and the extending portion of main shaft 33, but not proximal end 12, will rest between sliding panels 283 and 284. An alignment slot 298 and overlying shelf 299 may be provided to facilitate alignment and prevent buckling or kinking of the catheter and sealing member during use.
As shown in Figure 98, in one embodiment, indicia 260 are provided on catheter 10 and main shaft 33, which when aligned with indicia 270 on inflation adaptor 200, result in alignment of inflation port 22 with the fluid 10 tight inflation chamber of adaptor 200, and alignment of main shaft 33 with sliding panels 283 and 284, when catheter 10 and sealing member 30 are inserted into groove 240. Indicia 260 and 270 may take the form of markings, grooves or notches, or any other suitable means of aligning the valve with the inflation adaptor alignment indicia, may be provided. r,~ , the gap between indicia 260 on catheter 10 and main shaft 33 is approximately equal to the space between clips 271 and 272, such that by placing indicia 260 within clips 271 and 15 272, catheter 10 and main shaft 33 are properly aligned within adaptor 200.
Once main shaft 33 and inflation port 22 are properly aligned within adaptor 200, locking clip 230 is secured. Inflation port 22 now lies within the fluid tight inflation chamber created by gaskets 280, and main shaft 33 rests between sliding panels 283 and 284. The clinician may then attach an external,, i~ed fluid source to fitting 210.
To inflate balloon 20, the clinician moves actuator 220 from the first position to the second position, thereby causing sliding panels 283 and 284 to move away from opening 285. Because main shaft 33 is firmly secured between panels 283 and 284, a longitudinal force directed away from proximal end 12 is applied to main shaft 33. The longitudinal force on main shaft 33 results in wire 32 being partially ..ii' 'r .." from lumen 40, which causes sealer portion 36 on wire 32 to be moved to a position within lumen 40 which is proximal of inflation port 22. The ~c : of sealer portion 36 proximally of inflation port 22 opens the low profile valve, by eala'~ ' 9 an u",ts~ ed fluid pathway between inflation port 22 and balloon 20.
The external pressurized fluid source may then be activated, as for example by pushing the plunger on a syringe, such that "..5~ d fluid passes through pa 5151~ al 212 and opening 285 into the fluid tight inflation chamber. The p,essu,i~d fluid then passes through inflation port 22 and lumen 40, to inflate balloon 20.
Inflated balloon 20 may be maintained in the inflated state, in the absence of the p,~ss~ d fluid source, by closing the low profile valve. This is accomplished by moving actuator 220 back to the first position, thereby causing sliding panels 283 and 284 to move toward opening 285. The moving panels apply a 8 u ~' ' force, directed toward proximal end 12 to main shaft 33, causing wire 32 to be further inserted into lumen 40.
Conseq ~ , sealer portion 36 is moved from a position within lumen 40 which is proximal to inflation port 22 to a position in lumen 40 which is distal to inflation port 22. The fluid tight seal created by sealer portion 36 traps the, e~au,i~.id fluid within lumen 40 and balloon 20, thereby ". i .9 balloon 20 in the inflated state. The CA 022~6401 1998-11-20 W 097/44085 PCT~S97/08469 .19.
external p,~ i~dd fluid source may then be deactivated and removed. Once the low profile valve is closed, inflation adaptor 200 may be removed by unlocking clip 230, and removing catheter 10 and main shaft 33 from groove 240.
Referring to Figures 10 and 11, there is illustrated an alternative embodiment of an inflation adaptor especially adapted for -, ' i g ". )~ " low profile valves, although it may be used with s;'~ ascess - 5 ... L- ' Is as well. Adaptor 300 comprises an outer sleeve 320 formed of metal, medical grade p~'~carbonale, or similar such materials. Outer sleeve 300 defines a tapering inner lumen 350. Lumen 350 tapers from large diameter 352 which is significantly greater than the outer diameter of the catheter tubular bodies inserted into lumen 350, to a smaller diameter 355, which is slightly larger the outer diameter of the catheter tubular body. Lumen 350 is in fluid ~ . with an inflation pease~ . u; 312 formed by fitting 310, so that a p., i~dd inflation 10fluid may be introduced into lumen 350. Releasable seals 315 are pvs:kred at each end of lumen 350, such as to create a fluid tight inflation chamber within lumen 350 when a; l iL~,d fluid source is attached. F;e' a~~'' seals 350 may comprise any type of seal known to those of skill in the are, such as Toughy Borst coaaEctc ~, hl -- Ii~ valves, and the like. F ' e a~' seals 350 may also act to secure any catheters and sealing members inserted within the releasable seal openings 325 15In use, a catheter and sealing member, such as that described in cc.,aeci 1 with Figures 6-7, is inserted into opening 325 after seals 315 have been opened. The catheter and sealing member are pvs ared under p?r~ .ay 312, and the sealing member is removed from the proximal opening of the catheter. A fluid pass&s,,..
is thereby created between the proximal catheter opening and the PYp~m' '' member of the distal end of the catheter. Seals 350 are closed to create a fluid tight chamber, and a vacuum andlor u.tssu,i~dd inflation fluid is 20 applied, to inflate or deflate the balloon. After the desired inflation or deflation has occurred, the sealing member may be bltlGdlJcLd into the proximal opening of the catheter tubular body to seal the lumen, either by hand or by a movable actuator ~not shown). Seals 350 may then be loosened, and the end access adaptor 300 removed by sliding the adaptor off the end of the catheter and sealing member.
It will be app.dc;a~d that certain variations of the present invention may suggest 1' . s ~,s to those 25 skilled in the art. The foregoing detailed dLsc.i~. r. is to be clearly understood as given by way of illustration, the spirit and scope of this invention being limited solely by the appended claims.

.

Claims

WHAT IS CLAIMED IS:
1. A valve, comprising:
a flexible elongate tubular body having a proximal end and a distal end, and a central lumen extending between the proximal and distal end, the central lumen having an opening at the proximal end;
an expandable member on the distal end of the tubular body, the expandable member being in fluid communication with the central lumen;
an access opening on the tubular body, the access opening being in fluid communication with the central lumen to permit the expandable member to be actuated by pressurizing the access opening;
a sealing member having a sealer portion which seals against a surface of the tubular body, said portion of the sealing member being movable relative to said surface of the tubular body between two positions, one of the positions positioning the sealer portion in contact with said surface at a location which blocks the flow of fluid to or from the expandable member through the access opening to maintain actuation of the expandable member, the other of the positions positioning the sealer portion at a location which permits the flow of fluid to or from the expandable member through the access opening to permit actuation or deactuation of the expandable member.
2. The valve of Claim 1, wherein the sealing member has a portion which extends from the proximal end of the tubular body, and wherein the application of a proximal longitudinal force on the extending portion results in proximal movement of the sealer portion within the lumen, and the application of a distal longitudinal force of the extending portion results in a distal movement of the sealer portion within the lumen.
3. The valve of Claim 1, wherein the sealer portion is formed a polymeric material.
4. The valve of Claim 3, wherein the sealer portion is formed in part of a material selected from the group consisting of Pebax (TM), C-Flex (TM) or silicone.
5. The valve of Claim 1, wherein the sealer portion is capable of withstanding pressures up to 10 atmospheres and prevent substantially all fluid from passing to or from the balloon through the access opening when the sealer portion is positioned distal to the access opening.
6. The valve of Claim 5, wherein the sealer portion is capable of undergoing 10 valve-opening and closing cycles and, at a pressure of ten atmospheres, still prevent substantially all fluid from passing to or from the balloon through the access opening when the sealer portion is positioned distal to the access opening.
7. The valve of Claim 1, wherein at least a portion of the sealing member is formed of a metal selected from the group consisting of nitinol, stainless steel, Elgilog (TM), or combinations thereof.
8. The valve of Claim 1, wherein the outer diameter of the tubular body is larger than the outer diameter of any portion of the sealing member or sealer portion.
9. The valve of Claim 8, wherein the outer diameter of the tubular body is no greater than 0.038 inches.
10. The valve of Claim 9, wherein the outer diameter of the tubular body is no greater than 0.020 inches.

11. The valve of Claim 10, wherein the outer diameter of the tubular body is no greater than 0.014 inches.
12. The valve of Claim 1, further comprising positive stops to prevent withdrawal of the sealing member from the opening.
13. The valve of Claim 2, further comprising force-increasing structure which increases the longitudinal force which must be applied to the extending portion to move the sealer portion.14. The valve of Claim 1, further comprising an inflation adaptor capable of receiving the valve, the inflation adaptor providing a fluid tight chamber for introduction of a pressurized fluid to expand the expandable member.
15. The valve of Claim 1, wherein the access opening comprises a side-access port positioned on the tubular body at a point proximal to the tubular body distal end.
16. The valve of Claim 1, wherein the access opening is the central lumen opening.
17. An apparatus, comprising:
a hollow metallic guidewire having a central lumen and a side-access port in fluid communication with the lumen;
an inflatable balloon mounted on the guidewire, the inflatable balloon being in fluid communication with the central lumen, such that fluid introduced through the side-access port can be used to inflate the balloon;
a valve mounted to slide along a surface of the guidewire, said valve movable between first and second positions, one of said positions sealing the central lumen such that substantially no fluid may pass to or from the inflatable balloon by way of the side-access port.
18. The apparatus of Claim 17, wherein the hollow guidewire has an outer circumference defining a first value, and wherein the movable valve has a circumference which is less than the first value.
19. The apparatus of Claim 18, wherein the hollow guidewire has an outer circumference of 0.044 inches or less.
20. The apparatus of Claim 17, wherein the movable valve has a diameter not substantially larger than that of the hollow guidewire, and wherein said valve seals against an interior surface of said hollow guidewire.
21. A low profile catheter valve, comprising:
a sealing member capable of being movably inserted through a proximal opening on a catheter into an inflation lumen of the catheter, the catheter having a side-access inflation port and an inflatable balloon in fluid communication with the side-access inflation port;
a sealer portion on the sealing member, the sealer portion being capable of forming a fluid tight seal with the entire circumference of a section of the lumen, such that substantially all fluid may not pass the sealer portion;
wherein when the sealer portion is positioned within the lumen proximally of the side-access inflation port, an unrestricted fluid pathway is established between the side-access inflation port and the balloon, and when the sealer portion is positioned within the lumen distally of the side-access inflation port, substantially all fluid may not pass to or from the balloon through the side-access inflation port.
22. A method of inflating a catheter balloon, comprising the steps of:
providing a tube having a proximal end and a distal end, the proximal end having an inflation opening to an inflation lumen and the distal end having an inflatable balloon in fluid communication with the inflation lumen;
introducing a pressurized inflation fluid through the inflation opening to inflate the balloon; and sealing the inflation opening by moving a sealing member within the inflation lumen without reducing the pressure of the pressurized fluid, wherein the step of sealing is performed without deflating the inflated balloon;
reducing the pressure of the pressurized fluid after completing the sealing step.
23. A low profile catheter valve for use with an inflation adaptor, comprising:
a catheter having an inflation opening for inflating an inflatable member in fluid communication with the inflation opening;
a sealing member movably mounted in the catheter for selectively blocking fluid flow between the inflation opening and the inflatable member;
indicia on at least one of said catheter and said sealing member, the position of the indicia being such that alignment of said indicia with corresponding indicia on the inflation adaptor causes the inflation opening to be disposed within a fluid tight inflation chamber of the inflation adaptor.
24. An inflation adaptor for introducing inflation fluid into an inflation port of an elongate tube, comprising:
a housing with a retaining portion which interacts to releasably retain a section of said tube therein, said housing having a chamber which receives said inflation port, said housing further comprising;
an inflation inlet configured to be connected to a source of inflation fluid that supplies said fluid under pressure;
a seal which releasably seals said portions of said housing together, said seal providing a fluid pathway between said inflation inlet and said inflation port, whereby said fluid is supplied to said inflation port under pressure; and an actuator, mounted on said housing, which drives a member within said tube to control fluid flow through said inflation port.
25. The inflation adaptor of Claim 24, wherein said seal is formed by alignment and contact of a first and second gasket.
26. The inflation adaptor of Claim 24, further comprising indicia on said elongate tube and said housing, said indicia facilitating alignment of said inflation port and said chamber.
27. The inflation adaptor of Claim 24, wherein said actuator controls sliding panels which drive said tube member.

28. An inflation adaptor for introducing inflation fluid into an inflation port of an elongate tube, comprising:
a housing comprised of first and second portions which are relatively movably mounted to receive a section of said tube that includes the inflation port, said housing having an inflation chamber and an inflation inlet for introducing inflation fluid under pressure into said inflation chamber, said inflation chamber releasably sealing said inflation port to said inflation inlet to form a fluid passage there between.
29. An inflation adaptor for introducing inflation fluid into an inflation port of an elongate tube having an inflatable member mounted thereon and an inflation lumen between the inflation port and the inflatable member, said adaptor comprising:
a housing configured to seal over said tube to create a fluid tight inflation chamber, said housing having an inflation inlet and establishing a fluid pathway between the inflation inlet and the inflation port to permit the inflatable member to be inflated, said housing being detachable from said tube without deflating the inflated inflatable member.