.
`United States Patent
`Samson
`
`19)
`
`AUISAA
`US005304198A
`[11] Patent Number:
`5,304,198
`[45] Date of Patent:
`Apr. 19, 1994
`
`Primary Examiner—Ralph Lewis
`[54] SINGLE-LUMEN BALLOON CATHETER
`Attorney, Agent, orFirm—Morrison & Foerster
`HAVING A DIRECTIONAL VALVE
`(57)
`ABSTRACT
`Inventor: Gene Samson, Milpitas, Calif.
`[75]
`This invention is a single-lumen balloon catheter having
`[73] Assignee: Target Therapeutics, Fremont, Calif.
`a valve seat on the distal end.of the catheter, distal of
`the balloon, which may be operated by a control wire
`[21] Appl, No.: 976,197
`having a valve plug disposed on the wire. The valve
`[22] Filed:
`Nov. 13, 1992
`seat may be engaged by the valve plug from either
`direction, depending on the installation of the control
`[51)
`Tint, C15 vocesccceccceteterrenseeseeeeree A61M 25/00
`wire. In either event, if the valve plug is installed dis-
`[52] US. Cl. ..ccccscsssscccsesssceesessssneeees 606/194; 604/96;
`604/249; 128/772_tally of the valveseat in the catheter lumen, the valveis
`[58] Field of Search.................. 606/192, 194; 604/33,
`closed by pulling on the control wire (or moving the
`604/96, 99, 101-103, 246, 249, 170; 128/772—control wire in a proximal direction) and introducing
`*
`fluid through the catheter lumen through the balloon.
`[56]
`References Cited
`Alternatively,
`the guidewire, with itsintegral valve
`U.S. PATENT DOCUMENTS
`plug, may be introduced from the proximal end of the
`396,754
`1/1889" Mayfield wsscessssssssssssssssessee 604/249
`catheter and may traverse the body ofthe balloon to
`1,878,671
`9/1932 Cantor c.cecsecsecsseceessescesareseses 604/170
`engage the valve seat in the distal end of the catheter.
`1,920,006
`7/1933 Dozier... 604/170
`Pushing on the control wire will seat the valve, allow-
`3,467,101
`9/1969 Fogarty et ab. sess 606/194
`ing the introduction offluid through the catheter lumen
`3,841,308 10/1974 Tate .rsrereesssreerarererersens 604/249
`to inflate the balloon. Thelatter arrangement allows the
`4,413,989 11/1983 Schjeldahl et al.
`.scsseusesssen 604/96
`control wire to be interchanged with other guidewiresa
`4,848,344
`7/1989 SOS et Al. sevcnsnnseonrenne 606/194
`rol
`;
`4,944,740 7/1990 Buchbinderet ab. vscscunun 606/194
`Physician may wish to use. The balloon providedforin
`4,994,032
`2/1991
`Sugiyamaet al
`606/194
`this invention is of a single length and does not change
`
`5,100,381
`3/1992 BUMS veces606/194
`its axial lengthas it is inflated.
`
`8/1992 Engelson et al. occ 606/194
`5,135,494
`5/1993 Winters .....-.sssseseeseseesessesees 128/772
`5,207,229
`
`
`
`
`24 Claims, 2 Drawing Sheets
`
`
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`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1022 - Page 1
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1022 - Page 1
`
`

`

`U.S. Patent
`
`Apr. 19, 1994
`
`Sheet 1 of 2
`
`~ 5,304,198
`
`nd re NarhealMerrell
`
`lO4
`
`FIG.
`
`2
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1022 - Page 2
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1022 - Page 2
`
`

`

`U.S. Patent
`
`Apr. 19, 1994
`
`Sheet 2 of 2
`
`~ 5,304,198
`
`os
`
`\18
`
`an
`i"
`
`FIG. 3A
`
`302
`304
`
`
`FIG. 3B
`
`
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1022 - Page 3
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1022 - Page 3
`
`

`

`1
`
`5,304,198
`
`2
`which showsa catheter having anevertible balloon atis
`distal tip. The distal.tip of the catheter is placed near the
`stenosis to be treated. The balloon is extended beyond
`the distal tip to a position within the stenosis and then
`inflated to press the lesion back into the wall of the
`vessel. The balloon contains a passagewayin the middle
`having a plug of some elastomeric material through
`which a guidewire may be placed. The plug retains the
`pressure of the fluid on the balloon, whether the guide-
`wire is present or not.
`Another “over-the-wire” catheter is shown in U.S.
`Pat. No. 5,085,636, to Burns. The Burnsdeviceutilizes
`a balloon having a port for introducing fluid into the
`balloon and simultaneous device for not allowing fluid
`to pass through the catheter when a guidewire is pres-
`ent in the vicinity of the balloon. The fluid seal is dis-
`tendible and does notallow fluid past the guidewire.
`MyU.S. Pat. No. 5,171,221, entitled “Single Lumen
`Low Profile Valved Balloon Catheter” discloses a sin-
`gie lumen balloon catheter having a catheter using a
`flexible guidewire which extends axially through the
`lumen beyond the open end ofan intermediate balloon
`segment. The guidewire is axially movable within the
`lumen and has twodiscrete portionsof different diame-
`ters. The first diameter, distal on the guidewire,
`is
`smaller that a second more proximal diameter on the
`guidewire. The larger guidewire meshes with the diam-
`eter of the lumen just proximal of the balloon thereby
`sealing it on the proximal end. Simultaneously at the
`distal end of the balloon a valve member mounted on
`the guidewire blocks the distal opening of the catheter.
`Noneofthe prior art shows a device in which a con-
`trol wire having a valve plug mounted thereon, which
`mesheswith a valve seat mounted within the lumen and
`in which the balloon maintains a constant axial length
`during its distension.
`SUMMARY OF THE INVENTION
`This inventionis a single lumen valved balloon cathe-
`ter assembly with a single lumen having a proximalend,
`an open distal end, a valve seat section located towards
`the distal end of the catheter having both distal and
`proximal valve surfaces. The catheter body has a bal-
`loon section proximal of the valve section having an
`inflatable balloon. The balloon segment or section in-
`cludes therein a balloon inner member, the interior of
`whichis generally colinear with the lumenin the cathe-
`ter body, and which balloon inner memberallowsfluid
`communication between the catheter lumen and the
`interior of the balloon. The invention also includes a
`flexible guidewire extending axially through the lumen
`beyond the open end, the guidewire being axially mov-
`able within the lumen and having a valve plug disposed
`near the distal end of the guidewire. The valveplug is of
`such a size and configuration that is able to close the
`lumen to fluid flow upon engagement with either the
`proximalor distal surface of the valve seat. The guide-
`wire and its valve seat are produced in such a fashion
`that the guidewire may be introduced into the catheter
`lumen from the distal end thereby allowing the valve
`plug to contact the distal valve seat or the guidewire
`may beinstalled from the proximal end thereby allow-
`ing the valve plug to contact the proximal valve sur-
`face. Optional, but very desirable,
`is a catheter body
`section proximal of the balloon section which is suffi-
`ciently stiff to permit use of the guidewire-valve plug in
`sealing the valve. Preferably, the catheter body section
`
`SINGLE-LUMEN BALLOON CATHETER HAVING
`A DIRECTIONAL VALVE
`
`FIELD OF THE INVENTION
`
`This invention is a single-lumen balloon catheter
`having a valve seat on the distal end of the catheter,
`distal of the balloon, which may be operated by a con-
`trol wire having a valve plug disposed on the wire. The
`valve seat may be engaged by the valve plug from ei-
`ther direction, depending on the installation of the con-
`trol wire. In either event, if the valve plug is installed
`distally of the valve seat in the catheter lumen,the valve
`is closed by pulling on the control wire (or moving the
`control wire in a proximal direction) and introducing
`fluid through the catheter lumen through the balloon.
`Alternatively,
`the guidewire, with its integral valve
`plug, may be introduced from the proximal end of the
`catheter and may traverse the body of the balloon to
`engage the valve seat in the distal end of the catheter.
`Pushing on the control wire will seat the valve, allow-
`ing the introductionoffluid through the catheter lumen
`to inflate the balloon. Thelatter arrangementallowsthe
`control wire to be interchanged with other guidewires a
`physician may wish to use. The balloon provided for in
`this invention is of a single length and does not change
`its axial length as it is inflated.
`
`BACKGROUNDOF THE INVENTION
`
`Angioplasty is an excellent method for treating a
`wide variety of vascular diseases. In particular, it has
`been used extensively for opening stenoses in coronary
`arteries. The process has been increasingly used for
`treatment of stenosis in other parts of the vascular sys-
`tem.
`One of the more well known and widely practiced
`forms of angioplasty makes use ofa dilatation catheter
`which has an inflatable balloon at is distal end. Using
`fluoroscopy, the physician guides the catheter through
`the vascular system until the balloon is properly posi-
`tioned. By applying a fluid through the separate infla-
`tion lumen, the balloon is inflated. The balloon’s infla-
`tion causes the artery to stretch and pressesthe lesion or
`stenose into the artery wall, thereby reestablishing after
`deflation of the balloon, increased blood flow through
`the artery.
`In orderto treat very tight stenoses, i.e., those having
`small openings, increasingly small catheter diameters
`are desirable. significantly more flexible catheters are
`also desired in that otherwise very tight areas of stenosis
`will not be approachable. Although flexible and narrow
`of diameter, a good catheter must also be easily intro-
`duced and easily advanced through the tortuous path of
`the vascular system.
`There are a variety of dilatation catheter types. Many
`use multiple lumens. For instance, a catheter may use a
`separate guidewire lumen so that a guidewire can be
`used to establish the path to the stenosis. The catheter
`maythen be fed over the guidewire until the balloon is
`positioned overthe stenosis. The catheter obviously has
`a separate lumen to allow introduction of and removal
`of fluid for the balloon.
`Other catheter designs include those which act as
`their own guidewire, thereby eliminating the need for a
`separate guidewire lumen. Elimination of the need for
`the separate lumen meansthatthe profile of the catheter
`can be somewhat smaller. Typical of such integral de-
`signs are U.S. Pat. No. 4,606,247, to Fogarty et al.,
`
`25
`
`35
`
`40
`
`45
`
`35
`
`60
`
`65
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1022 - Page 4
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1022 - Page 4
`
`

`

`5,304,198
`
`FIGS. 1A and 1B are partial, enlarged, semicross
`sectional depictions of the distal portion of the catheter
`made accordingto this invention.
`FIG. 2 showsa close up side view of the distal por-
`tion of a guidewire suitable for use in this invention.
`FIGS. 3A and 3B showside views of two variations
`of the balloon inner member.
`FIGS. 3C and 3D show enlarged partial cross-sec-
`tions ofstill further variations of the balloon inner mem-
`ber.
`
`DESCRIPTION OF THE INVENTION
`
`4
`3
`ber (110) may be coextruded with the outer tubing (108)
`is a multilayered, polymeric tubing that does not kink,
`or may be a discrete member. Suitably lubricious mate-
`“accordion”, or stretch upon application of axial force
`rials include polysulfides and polyfluoroethylenes. Suit-
`on the guidewire. The most preferred combination of
`able polyfluoroethylenes include polytetrafluoroethyl-
`materials is a slippery material as the innersurface of the
`ene, fluoroethylene copolymers having perfluoroalkoxy
`section surrounded by a high performance engineering
`groups, copolymersoftetrafluoroethylene, hexafluoro-
`polymer such as polyimide.
`propylene, and copolymersof ethylene and tetrafluoro-
`The catheter may be of a very small diameter or low
`ethylene. Most preferred ate copolymersof tetrafluoro-
`profile and consequently is quite flexible in its opera-
`tion.
`ethylene and hexafluoroethylene.
`Although the balloon (112) may be made out of a
`The balloon inner member maybe any of a numberof
`variety of materials, I have found that the balloon is
`devices allowing fluid communication between the
`catheter lumen and the interior of the balloon. For
`readily formed from a length of radiation-hardened
`polyolefin tubing. The chosen polyolefin may be low
`instance, the balloon inner member may beacoil, a
`density polyethylene, high density polyethylene, poly-
`braid, a braid or coil supported by a tube having holes
`propylene, polybutene, or interpolymers or mixtures of
`throughits wall, or a tube having holes throughits wall.
`these polymers. In any event, a balloon may be formed
`BRIEF DESCRIPTION OF THE DRAWINGS
`by closing one end and applying about 20 to 45 pounds
`per squareinch of pressure within the tube and heating
`the portion which is to form the balloon to a tempera-
`ture of between 300°-350° F. Obviously, the length of
`the balloon formed is determined by the length of the
`tubing heated. After the balloon is produced in an ap-
`propriate size, the heat is removed, and the balloon is
`allowed to cool. The ends may be cutso to fit in the
`catheter assembly. Typically the balloon is squeezed to
`a size near that of the catheter lumen. Theratio of the
`collapsed diameterof the balloon to the diameterof the
`catheter just proximal of the balloon is no more than
`about 1.2 to 1 and preferably no more than about 1.1 to
`1. The production of the balloon in this fashion results
`in a device in which the diameter of the balloon before
`inflation as compared to the diameter of the balloon
`after inflation may be about 1:6 or less. The balloon
`madein this fashion is also axially very certain in size.
`Unlike elastomeric balloons which may vary in length
`wheninflated, this balloon is essentially isoaxial, partic-
`ularly when the balloon inner members described
`herein are utilized. The balloon inner member assembly
`(114) shown in FIGS. 1A and 1B has two ends (116) and
`a coil spring (118). This construction will be described
`in more detail below.
`;
`Finally, the valve portion of the catheter assemblyis
`preferably inserted into the portion of the balloon hav-
`ing relatively constantinner diameter.It is held in place
`by heat welding or gluing or other suitable process. The
`valve region (106) with its ring (120) and proximal valve
`surface (122) and distal valve surface (124) may be made
`by the following procedure. Other proceduresare cer-
`tainly acceptable but I have found that the following
`procedure produces an excellent result. A polymeric
`tube having an inside diameter larger than the guide-
`wire is stretched over a mandrel suchas a suitably sized
`stainless steel wire. The ends are locked over the man-
`drel by heating. A temperature of about 600° F.to ap-
`propriate when the chosen polymeris a polyimide. A
`ring having an appropriate inside diameter is slipped
`over the tubing. The locked endsof the tubing are cut
`off to allow the tubing to recoverits original dimen-
`sions. Polyimide tubing recovers fully by heating it to
`about 550° F. The ring maybe ofgold, platinum,plati-
`num-tungstenalloy, stainless steel, or other suitable and,
`preferably, radioopaque materials. The tubing, upon
`return to its former diameter, formsdistal and proximal
`surfaces adjacent the ring which serve as valve surfaces
`for the plug residing on the guidewire.
`This distal structure substantially eliminates the possi-
`bility of “accordioning” when the distal valve surface
`(124) is used as the valve seat.
`
`FIGS. 1A and 1B show the distal portion, generally
`designated (100), of a catheter assembly made accord-
`ing to one embodimentof the invention. FIG. 1A de-
`picts the distal end of the catheter assembly when the
`guidewire has been inserted with the valve plug (104)
`distally of the valve section (106). FIG. 1B showsthe
`same catheter assembly (100) with the guidewire (102)
`with a valve plug (104) positioned proximately of the
`valve region (106).
`Referring to FIG. 1A, the catheter body generally is
`madeupofan outer, thinwall tubing (108) and an inner
`tubing (110). The balloon body (112), having the bal-
`loon inner member(114), which balloon under member
`114 is made up of balloon inner member endsections
`(116) and a fluid permeable member (118). Distally of
`balloon (112) is located the valving for the catheter. The
`valving is a valve section (106) which may be made up
`of a simple tube having a meta! band (120) located so as
`to form a valve surface (122) proximally of the metal
`band (120) on the interior of the lumen and a valve
`surface (124) distally of the band (120).
`The catheter (100) has a body section (109) proximal
`of the balloon section which desirably is made up of an
`outer tubing (108) which is strong and flexible and an
`inner tubing member(110). Although there are a num-
`ber of materials which are suitable for service as the
`outer tubing, ¢.g., high density polyethylene (HDPE),
`low density polyethylene (LDPE), certain highly cross
`linkedsilicones, polyesters (including Nylon), polyviny!
`chloride, high molecular weight polyurethanes, and
`various polyimides. Of those materials, a polyimide is
`the most desirable in that
`it has a substantial axial
`strength and is therefore quite “pushable” but also
`maintains the catheter lumen open even under the se-
`verest of pressure. The distal portion of this catheter
`bodyis preferably of a much moreflexible material such
`as low density polyethylene.
`The inner tubing member(110) is not a required por-
`tion of the inventive device but is desirable. The mem-
`
`id 0
`
`20
`
`40
`
`45
`
`50
`
`55
`
`60
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1022 - Page 5
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1022 - Page 5
`
`

`

`5,304,198
`
`25
`
`35
`
`45
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`6
`5
`Typically the inside diameter of coil (118) would be
`FIG. 1B simply showsthe insertion of the guidewire
`0.020 to 0.035 of an inch. The diameter of coil wire
`(102) from the proximal end-of the catheter so to allow
`typically would be in the region of 0.003 to 0.005 of an
`the valve plug (104) to seat against the proximal valve
`inch. The coil itself (118) may be wound in such a way
`surface (122). In this instance the valve is seated by
`that there is little space between windings. Ideally, the
`pushing the guidewire (102) distally prior to filling the
`windingsare flush with each other. That is to say the
`balloon (112) with a fluid via the catheter lumen.
`pitch of the coil is equal to the diameter of the wire
`Someclinical situations require that the balloon cath-
`making up the coil. The coil may be of any suitable
`eter be used in conjunction with a specific or preferred
`material although gold alloys, silver alloys, platinum
`guidewire to gain access to the vascular anatomy. Some
`alloys, and other biocompatible materials having signifi-
`clinical situations also require that site-specific drugs
`cant springiness are appropriate in this service. Poly-
`such as urokinasefor clot dissolution or contrast materi-
`meric materials or carbon fiber materials having the
`als for fluoroscopic imaging be delivered through the
`appropriate physical characteristics are also quite work-
`catheter before a balloon angioplasty is performed.
`able.
`During such clinical situations, the inventive catheter
`FIG. 3B shows braided balloon inner member in
`maybeused in conjunction with any guidewire of com-
`which a braid (304) is substituted for the spring or coil
`patible size to gain access to the vascular anatomy. The
`(118) shown in FIG. 3A. The materials of construction
`catheter may be used as an infusion catheter if so de-
`and size of the wire or ribbon making up the braid are
`sired. If a balloon angioplasty is then desired, the guide-
`quite similar to the coil (118) shownin 3A.
`wire are removed and the inventive guidewire (102)
`FIG. 3C showsa device similar to that shownin FIG.
`having the valve plugis introduced at the proximal end
`3A,in that a coil is used to permit the flow offluid from
`of the catheter, engaged with the valve surface (122)in
`the lumen inside the balloon inner member (306) into
`valve region (106), and the ballooninflated. This proce-
`the body of the balloon,as is shown in FIGS. 1A or 1B.
`dure ofnot replacing the infusion catheter by a balloon
`In this instance, the balloon inner member (306) addi-
`catheter and of merely substituting guidewires is quite
`tionally contains an interior tubing (308) coaxial to the
`efficient and is desirable in procedures such as cerebral
`coil (310). The inner tubing (308) has a numberofori-
`angioplasty where timeis a critical element.
`fices (312) to permit fluid flow. The inner member(308)
`The guidewires (112) used in these devices are
`may be of metal, polymer, carbon or other suitable
`straightforward. The shape of the valve plug (104) is
`biocompatible material. Desirably the tubing is a poly-
`relatively unimportant so long as it meshes adequately
`meric material such as a polyimide, which is stiff,
`with the valve surfaces formed in valve region (106). I
`strong, and biocompatible. The endsof the inner tubing
`have found that a spherical surface is adequate and
`(308) adhereto the respective ends. FIG. 3C is a partial
`desirable. Moreover, in addition to the relatively simple
`cutaway showing both the interior and the exterior of
`guidewires of varying thicknesses as are known in this
`the balloon inner member (306).
`technology and shown in FIGS.1A and 1B,the guide-
`FIG. 3D showsa partial cutaway ofa balloon inner
`wire used in this invention may additionally have a
`member(314) which is analogous to that shown in FIG.
`flexible tip (202) as in shown in FIG. 2. These flexible
`3C, except that instead ofcoil (310), the exterior of the
`tips are well known. They are used with the aid of
`inner tubing (308) is a braided material (316). The coil of
`fluoroscopy to advancethe catheter through the vascu-
`FIG. 3C and the braid of FIG. 3D are optional.
`lature. The body of the catheter (with the collapsed
`The catheter assembly of the invention is operated in
`balloon) is moved distally along the guidewiretoasite
`similar fashion to other valve balloon catheters. In such
`where the guidewire may be again introduced farther
`operation, the guidewire is advanced into the vascula-
`into the vasculature until a desiredsite is attained. Obvi-
`ture to a desired site, and the catheter body is tracked
`ously, use of the guidewire in this fashion typically
`over the guidewire. The location of the guidewire and
`requires that the guidewire be introduced into the cath-
`the balloon within the vessel may be determined by
`eter body from the distal end rather than from the proxi-
`conventional radiology techniques. Oncethe balloon is
`mal end.
`at the desired site within the vessel, the catheter lumen
`FIGS. 3A through 3D show a variety of balloon
`is flushed byinjecting fluid through the catheter lumen,
`inner members which help to provide axial length sta-
`the valve plug (104) is seated against the distal valve
`bility to the balloon (112) shown in FIGS. 1A and 1B
`surface (124) or the proximal valve surface (122), de-
`and maintain the lumen within the valve region in gen-
`pending upon the end from which the guidewire was
`eral colinear relationship with the lumen of the more
`introduced, by axially manipulating the guidewire. The
`proximalportions of the catheter assembly.
`valve plug (104) blocks the distal opening of the cathe-
`FIG. 3A showsa simple balloon inner member(114)
`ter tube. The balloon is then inflated by injecting fluid
`as was included in the devices shown in FIGS. 1A and
`through the catheter lumen.If desired, controlled distal
`1B. Balloon inner member(114) is made up of two ends
`leakage of the fluid from the catheter tip may be
`(116) and a spring (118). The endsserve to allow mount-
`achieved by a slight adjustment in the tightness of the
`ing ofthe balloon inner member (114)in the sections of
`seating between valve plug (104) and the respective
`the catheter having reasonably constant diameter. The
`valve seating areas. The balloon may be deflated by
`inner diameter may be large enough to pass the valve
`withdrawingfluid from the catheter lumen.
`plug (104) therethrough or may be smallerto allow only
`Manyalterations and modifications may be made by
`the guidewire to pass. The ends have,of course, a lumen
`those of ordinary skill in the art without departing from
`allowing a guidewire to pass completely through the
`the spirit and scope of this invention. The illustrated
`ends and through the intermediate coil (118). The ends
`embodiments have been shown only for purposes of
`(116) may be attached to the coil (118) by any suitable
`clarity. The examples should notbe taken as limiting the
`meansincluding gluing, shrink wrapping, heat welding,
`invention as defined by the following claims, which
`solvent welding, and a host of other ways. The spring
`claims include all equivalents, whether those equiva-
`(118) involved is one having an inside diameterat least
`lents are now orlater devised.
`larger than that of the guidewire passing throughit.
`
`30
`
`50
`
`55
`
`65
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1022 - Page 6
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`Petitioner Edwards Lifesciences Corporation - Exhibit 1022 - Page 6
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`

`

`5,304,198
`
`20
`
`25
`
`30
`
`35
`
`8
`7
`10. The catheter of claim 8 wherein the balloon inner
`.
`I claim as my invention:
`member additionally comprises a braided or woven
`1. A single-lumen balloon catheter assembly compris-
`tubing coaxially disposed about the perforated tubing.
`ing a catheter body having proximal and distal ends, a
`11. The catheter of claim 6 wherein the balloon inner
`single lumen extending between those proximal and
`member comprises a braided or woven tubing.
`distal ends, an inflatable balloon having proximal and
`12. The catheter of claim § wherein the balloon inner
`distal ends disposed in the distal region of the catheter
`member comprises a coil.
`body, a valve seat disposed betweenthedistal end of the
`13. The catheter of claim 5 wherein the balloon inner
`inflatable balloon and the distal end of the catheter
`member comprises perforated tubing.
`body, which valve seat is formed by a circumferential
`14. The catheter of claim 13 wherein the balloon
`band cinching a portion of the catheter body forming
`inner member additionally comprises a coil coaxially
`distal and proximal valve surfaces, and allows passage
`disposed aboutthe perforated tubing.
`of acontrol wire therethrough,andis adapted to engage
`15. The catheter of claim 13 wherein the balloon
`and seal said lumen, both on its distal and proximal
`inner member additionally comprises a braided or
`valve surfaces, with a valve plug disposed on a control
`woven tubing coaxially disposed about the perforated
`wire.
`tubing.
`16. The catheter of claim 5 wherein the balloon inner
`2. The catheter assembly of claim 1 also comprising a
`member comprises a braided or woven tubing.
`control wire having distal and proximal ends, having a
`17. The catheter of claim 2 wherein the ratio of the
`valve plug disposed near its distal end adapted to en-
`diameter of the balloon before inflation and the diame-
`gageandseal said lumenby contacting either the distal
`ter of the balloon after inflation is less than 1:6.
`or proximal valve surfaces by sliding axially through
`18. The catheter of claim 2 wherein the diameter of
`the catheter lumen, and adapted to be introduced into
`the balloon before inflation is within 10% of the diame-
`the catheter body either through the proximal or distal
`ter of the catheter body proximal of the inflatable bal-
`ends.
`loon.
`3. The catheter of claim 2 wherein the control wire is
`19. The catheter of claim 2 wherein the circumferen-
`a guidewire having a proximalend andadistal tip.
`tial band is radiopaque.
`4. The catheter of claim 3 wherein the guidewire
`20. The catheter of claim 2 wherein the valve plug is
`additionally comprises a bendable guidetip atits distal
`spherical.
`tip.
`21. The catheter of claim 2 wherein the catheter body
`5. The catheter of claim 2 wherein the inflatable bal-
`comprises a polyimide tubing coaxially surrounding a
`loon additionally comprises a balloon inner member
`lubricious polymeric layer.
`allowing fluid communication between the lumen and
`22. The catheter of claim 21 wherein the lubricious
`the inflatable balloon and extending between thedistal
`polymeric layer comprises a fluoroethylene polymer.
`6. The catheter of claim 5 wherein the balloon inner
`23. The catheter of claim 22 wherein the fluoroethyl-
`memberis additionally adaptedto allow axial passage of
`ene polymeris selected from polytetrafluoroethylene,
`fluoroethylene copolymers having perfluoroalkoxy
`the valve plug.
`groups, copolymers of tetrafluoroethylene and hexa-
`7. The catheter of claim 6 wherein the balloon inner
`fluoropropylene, and copolymersof ethylene andtetra-
`member comprises a coil.
`8. The catheter of claim 6 wherein the balloon inner
`fluoroethylene.
`24. The catheter of claim 23 wherein the fluoroethyl-
`membercomprises perforated tubing.
`ene polymer is a copolymeroftetrafluoroethylene and
`9. The catheter of claim 8 wherein the balloon inner
`hexafluoropropylene.*
`memberadditionally comprises a coil coaxially disposed
`*
`*
`*
`*
`about the perforated tubing.
`
`40
`
`45
`
`50
`
`55
`
`65
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1022 - Page 7
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1022 - Page 7
`
`