.
`Ulllted
`Samson
`
`Patent
`
`[19]
`
`lllllllllllllllllIlllllllllIlllllllllllllllllllllllllllllllllllllllllllllll
`USOOS304198A
`[11] Patent Number:
`[45] Date of Patent:
`
`5,304,198
`Apr. 19, 1994
`
`[54] SINGLE-LUMEN BALLOON CATHETER
`HAVING A DIRECTIONAL VALVE
`
`Primary Examiner—Ralph Lewis
`Attorney, Agent, or Firm—Morrison & Foerster
`
`[75]
`
`Inventor: Gene Samson, Milpitas, Calif.
`
`[57]
`
`ABSTRACT
`
`[73] Assignee; Target Therapeutics, Fremont, Calif.
`
`[21] APPL N03 976,197
`[22] Filed:
`No“ 13’ 1992
`I
`Int. Cl.5 ........................................... ..
`U.S. Cl. .................................... ..
`
`'
`
`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 control wire
`having a valve plug disposed on the wire. The valve
`seat may be engaged by the valve plug from either
`direction, depending on the installation of the control
`wire, In either event,
`the valve
`is
`dis-
`tally 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 throu h the balloon.
`Alternatively,
`the guidewire, with itsgintegral 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 introduction of fluid through the catheter lumen
`to inflate the balloon. The latter arrangement allows the
`control wire to be interchanged with other guidewires a
`h
`‘
`'
`'ht
`'d ‘
`p .ys1c1an may’ww 0_ use.
`6
`a oon provx e
`or m
`this invention IS of a Single length and does not change
`its axial length as it is inflated.
`
`24 Claims, 2 Drawing Sheets
`
`604/249; 128/772
`[58] Field Of Search ................ .. 606/192, 194; 604/33,
`604/96, 99, 101-103, 246, 249, 170; 123/772
`-
`References cued
`U-S- PATENT DOCUMENTS
`396,754
`1/1889’ Mayfield ........................... .. 604/249
`1,878,671
`9/1932 Cantor ......... ..
`,,,, _, 604/170
`
`1,920,006 7/ 1933 Dozier ................. ..
`.... .. 604/170
`3,467,101
`9/1969 Fogarty et al.
`..... ..
`
`.... .. 606/194
`3,841,308 10/1974 Tate ...........................
`~~~~ -- 604/249
`4,413,989 11/1983 Schjeldahl et a1.
`..... ..
`------ " 604/96
`4,848,344
`7/1989 505 et al.
`................. ..
`. . . . u
`4,944,740 7/ 1990 Buchbinder et al.
`___ 0 606/194
`606/194
`4,994,032
`2/1991 Sugiyama et al.
`...... ..
`5,100,381
`3/1992 Burns .................. ..
`.... “ 606/194
`5,135,494
`8/1992 Engelson et al.
`.... .. 606/194
`5,207,229
`5/1993 Winters ............................. .. 128/772
`
`
`
`[56]
`
`|09
`
`IOO
`
`“6 an" 116
`
`
`
`\
`'08
`l|4
`l O 6
`_ '
`--—------—-————-=m——-
`
`
`
`“0
`
`122
`
`'20 '24
`
`
`
`
`
`
`
`
`----- at --.b.-.
`
`-- -- -7-7- Amy-11.. --
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1022 - Page 1
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1022 - Page 1
`
`

`

`US. Patent
`
`Apr. 19, 1994
`
`Sheet 1 of2
`
`' 5,304,198
`
`-————-———————-—~-
`
`
`
`-----1-1£-r-!g
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1022 - Page 2
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1022 - Page 2
`
`

`

`US. Patent
`
`Apr. 19, 1994
`
`Sheet 2 of2
`
`I 5,304,198
`
`
`
`
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1022 - Page 3
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1022 - Page 3
`
`

`

`1
`
`5,304,198
`
`2
`which shows a catheter having an evertible balloon at is
`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 passageway in 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 Burns device utilizes
`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 not allow fluid past the guidewire.
`My U.S. Pat. No. 5,171,221, entitled “Single Lumen
`Low Profile Valved Balloon Catheter” discloses a sin-
`gle lumen balloon catheter having a catheter using a
`flexible guidewire which extends axially through the
`lumen beyond the open end of an intermediate balloon
`segment. The guidewire is axially movable within the
`lumen and has two discrete portions of 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.
`None of the prior art shows a device in which a con—
`trol wire having a valve plug mounted thereon, which
`meshes with a valve seat mounted within the lumen and
`in which the balloon maintains a constant axial length
`during its distension.
`
`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 introduction of fluid through the catheter lumen
`to inflate the balloon. The latter arrangement allows the
`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.
`
`BACKGROUND OF 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-
`tern.
`
`One of the more well known and widely practiced
`forms of angioplasty makes use of a 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 presses the lesion or
`stenose into the artery wall, thereby reestablishing after
`deflation of the balloon, increased blood flow through
`the artery.
`In order to 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
`may then be fed over the guidewire until the balloon is
`positioned over the 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 means that the 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.,
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`4O
`
`45
`
`50
`
`55
`
`65
`
`
`
`sealing the valve. Preferably, the catheter body section
`
`SUMMARY OF THE INVENTION
`
`This invention is a single lumen valved balloon cathe-
`ter assembly with a single lumen having a proximal end,
`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
`which is generally colinear with the lumen in the cathe-
`ter body, and which balloon inner member allows fluid
`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 valve plug is of
`such a size and configuration that is able to close the
`lumen to fluid flow upon engagement with either the
`proximal or 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 be installed 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
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1022 - Page 4
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1022 - Page 4
`
`

`

`
`
`5,304,198
`
`3
`is a multilayered, polymeric tubing that does not kink,
`“accordion”, or stretch upon application of axial force
`on the guidewire. The most preferred combination of
`materials is a slippery material as the inner surface of the
`section surrounded by a high performance engineering 5
`polymer such as polyimide.
`The catheter may be of a very small diameter or low
`profile and consequently is quite flexible in its opera-
`tion.
`The balloon inner member may be any of a number of 10
`devices allowing fluid communication between the
`catheter lumen and the interior of the balloon. For
`instance, the balloon inner member may be a coil, a
`braid, a braid or coil supported by a tube having holes
`through its wall, or a tube having holes through its wall.
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`15
`
`FIGS. 1A and 18 are partial, enlarged, semicross
`sectional depictions of the distal portion of the catheter
`made according to this invention.
`FIG. 2 shows a close up side view of the distal por-
`tion of a guidewire suitable for use in this invention.
`FIGS. 3A and 3B show side views of two variations
`of the balloon inner member.
`FIGS. 3C and 3D show enlarged partial cross-sec—
`tions of still further variations of the balloon inner mem-
`ber.
`
`20
`
`25
`
`DESCRIPTION OF THE INVENTION
`
`30
`
`35
`
`FIGS. 1A and 1B show the distal portion, generally
`designated (100), of a catheter assembly made accord-
`ing to one embodiment of 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. 18 shows the
`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
`made up of an 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 end sections
`(116) and a fluid permeable member (118). Distally of
`balloon (112) is located the valving for the catheter. The 45
`valving is a valve section (106) which may be made up
`of a simple tube having a metal 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, e.g., high density polyethylene (HDPE),
`low density polyethylene (LDPE), certain highly cross
`linked silicones, polyesters (including Nylon), polyvinyl
`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
`body is preferably of a much more flexible 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-
`
`50
`
`55
`
`65
`
`4
`ber (110) may be coextruded with the outer tubing (108)
`or may be a discrete member. Suitably lubricious mate-
`rials include polysulfldes and polyfluoroethylenes. Suit-
`able polyfluoroethylenes include polytetrafluoroethyl-
`ene, fluoroethylene copolymers having perfluoroalkoxy
`groups, copolymers of tetrafluoroethylene, hexafluoro-
`propylene, and copolymers of ethylene and tetrafluoro-
`ethylene. Most preferred are copolymers of tetrafluoro-
`ethylene and hexafluoroethylene.
`Although the balloon (112) may be made out of a
`variety of materials, I have found that the balloon is
`readily formed from a length of radiation-hardened
`polyolefm tubing. The chosen polyolefln may be low
`density polyethylene, high density polyethylene, poly-
`propylene, polybutene, or interpolymers or mixtures of
`these polymers. In any event, a balloon may be formed
`by closing one end and applying about 20 to 45 pounds
`per square inch 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 cut so to fit in the
`catheter assembly. Typically the balloon is squeezed to
`a size near that of the catheter lumen. The ratio of the
`collapsed diameter of the balloon to the diameter of 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
`l. 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
`made in this fashion is also axially very certain in size.
`Unlike elastomeric balloons which may vary in length
`when inflated, 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 18 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 assembly is
`preferably inserted into the portion of the balloon hav-
`ing relatively constant inner 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 procedures are 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 such as 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 polymer is a polyimide. A
`ring having an appropriate inside diameter is slipped
`over the tubing. The locked ends of the tubing are cut
`off to allow the tubing to recover its original dimen-
`sions. Polyimide tubing recovers fully by heating it to
`about 550° F. The ring may be of gold, platinum, plati-
`num-tungsten alloy, stainless steel, or other suitable and,
`preferably, radioopaque materials. The tubing, upon
`return to its former diameter, forms distal 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.
`
`
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1022 - Page 5
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1022 - Page 5
`
`

`

`
`
`5
`FIG. 13 simply shows the insertion of the guidewire
`(102) from the proximal end-of the catheter so to allow
`the valve plug (104) to seat against the proximal valve
`surface (122). In this instance the valve is seated by
`pushing the guidewire (102) distally prior to filling the
`balloon (112) with a fluid via the catheter lumen.
`Some clinical situations require that the balloon cath-
`eter be used in conjunction with a specific or preferred
`guidewire to gain access to the vascular anatomy. Some
`clinical situations also require that site-specific drugs
`such as urokinase for clot dissolution or contrast materi-
`als for fluoroscopic imaging be delivered through the
`catheter before a balloon angioplasty is performed.
`During such clinical situations, the inventive catheter
`may be used in conjunction with any guidewire of com-
`patible size to gain access to the vascular anatomy. The
`catheter may be used as an infusion catheter if so de-
`sired. If a balloon angioplasty is then desired, the guide-
`wire are removed and the inventive guidewire (102)
`having the valve plug is introduced at the proximal end
`of the catheter, engaged with the valve surface (122) in
`valve region (106), and the balloon inflated. This proce-
`dure of not replacing the infusion catheter by a balloon
`catheter and of merely substituting guidewires is quite
`efficient and is desirable in procedures such as cerebral
`angioplasty where time is a critical element.
`The guidewires (112) used in these devices are
`straightforward. The shape of the valve plug (104) is
`relatively unimportant so lOng as it meshes adequately
`with the valve surfaces formed in valve region (106). I
`have found that a spherical surface is adequate and
`desirable. Moreover, in addition to the relatively simple
`guidewires of varying thicknesses as are known in this
`technology and shown in FIGS. 1A and 1B, the guide-
`wire used in this invention may additiOnally have a
`flexible tip (202) as in shown in FIG. 2. These flexible
`tips are well known. They are used with the aid of
`fluoroscopy to advance the catheter through the vascu-
`lature. The body of the catheter (with the collapsed
`balloon) is moved distally along the guidewire to a site
`where the guidewire may be again introduced farther
`into the vasculature until a desired site is attained. Obvi—
`ously, use of the guidewire in this fashion typically
`requires that the guidewire be introduced into the cath-
`eter body from the distal end rather than from the proxi-
`mal end.
`FIGS. 3A through 3D show a variety of balloon
`inner members which help to provide axial length sta-
`bility to the balloon (112) shown in FIGS. 1A and 1B
`and maintain the lumen within the valve region in gen-
`eral colinear relationship with the lumen of the more
`proximal portions of the catheter assembly.
`FIG. 3A shows a simple balloon inner member (114)
`as was included in the devices shown in FIGS. 1A and
`IB. Balloon inner member (114) is made up of two ends
`(116) and a spring (118). The ends serve to allow mount-
`ing of the balloon inner member (114) in the sections of
`the catheter having reasonably constant diameter. The
`inner diameter may be large enough to pass the valve
`plug (104) therethrough or may be smaller to allow only
`the guidewire to pass. The ends have, of course, a lumen
`allowing a guidewire to pass completely through the
`ends and through the intermediate coil (118). The ends
`(116) may be attached to the coil (118) by any suitable
`means including gluing, shrink wrapping, heat welding,
`solvent welding, and a host of other ways. The spring
`(118) involved is one having an inside diameter at least
`larger than that of the guidewire passing through it.
`
`20
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`
`5,304,198
`
`IO
`
`15
`
`6
`Typically the inside diameter of coil (118) would be
`0.020 to 0.035 of an inch. The diameter of coil wire
`typically would be in the region of 0.003 to 0.005 of an
`inch. The coil itself (118) may be wound in such a Way
`that there is little space between windings. Ideally, the
`windings are flush with each other. That is to say the
`pitch of the coil is equal to the diameter of the wire
`making up the coil. The coil may be of any suitable
`material although gold alloys, silver alloys, platinum
`alloys, and other biocompatible materials having signifi-
`cant springiness are appropriate in this service. Poly-
`meric materials or carbon fiber materials having the
`appropriate physical characteristics are also quite work-
`able.
`FIG. 3B shows braided balloon inner member in
`which a braid (304) is substituted for the spring or coil
`(118) shown in FIG. 3A. The materials of construction
`and size of the wire or ribbon making up the braid are
`quite similar to the coil (118) shown in 3A.
`FIG. 3C shows a device similar to that shown in FIG.
`3A, in that a coil is used to permit the flow of fluid from
`the lumen inside the balloon inner member (306) into
`the body of the balloon, as is shown in FIGS. 1A or 1B.
`In this instance, the balloon inner member (306) addi-
`tionally contains an interior tubing (308) coaxial to the
`coil (310). The inner tubing (308) has a number of ori-
`fices (312) to permit fluid flow. The inner member (308)
`may be of metal, polymer, carbon or other suitable
`biocompatible material. Desirably the tubing is a poly-
`meric material such as a polyimide, which is stiff,
`strong, and biocompatible. The ends of the inner tubing
`(308) adhere to the respective ends. FIG. 3C is a partial
`cutaway showing both the interior and the exterior of
`the balloon inner member (306).
`FIG. 3D shows a partial cutaway of a balloon inner
`member (314) which is analogous to that shown in FIG.
`3C, except that instead of coil (310), the exterior of the
`inner tubing (308) is a braided material (316). The coil of
`FIG. 3C and the braid of FIG. 3D are optional.
`The catheter assembly of the invention is operated in
`similar fashion to other valve balloon catheters. In such
`operation, the guidewire is advanced into the vascula-
`ture to a desired site, and the catheter body is tracked
`over the guidewire. The location of the guidewire and
`the balloon within the vessel may be determined by
`conventional radiology techniques. Once the balloon is
`at the desired site within the vessel, the catheter lumen
`is flushed by injecting fluid through the catheter lumen,
`the valve plug (104) is seated against the distal valve
`surface (124) or the proximal valve surface (122), de-
`pending upon the end from which the guidewire was
`introduced, by axially manipulating the guidewire. The
`valve plug (104) blocks the distal opening of the cathe-
`ter tube. The balloon is then inflated by injecting fluid
`through the catheter lumen. If desired, controlled distal
`leakage of the fluid from the catheter tip may be
`achieved by a slight adjustment in the tightness of the
`seating between valve plug (104) and the respective
`valve seating areas. The balloon may be deflated by
`withdrawing fluid from the catheter lumen.
`Many alterations and modifications may be made by
`those of ordinary skill in the art without departing from
`the spirit and scope of this invention. The illustrated
`embodiments have been shown only for purposes of
`clarity. The examples should not be taken as limiting the
`invention as defined by the following claims, which
`claims include all equivalents, whether those equiva-
`lents are now or later devised.
`
`
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1022 - Page 6
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1022 - Page 6
`
`

`

`7
`.
`I claim as my invention:
`1. A single-lumen balloon catheter assembly compris-
`ing a catheter body having proximal and distal ends, a
`single lumen extending between those proximal and
`distal ends, an inflatable balloon having proximal and
`distal ends disposed in the distal region of the catheter
`body, a valve seat disposed between the distal end of the
`inflatable balloon and the distal end of the catheter
`body, which valve seat is formed by a circumferential
`band cinching a portion of the catheter body forming
`distal and proximal valve surfaces, and allows passage
`of a control wire therethrough, and is adapted to engage
`and seal said lumen, both on its distal and proximal
`valve surfaces, with a valve plug disposed on a control
`wrre.
`
`2. The catheter assembly of claim 1 also comprising a
`control wire having distal and proximal ends, having a
`valve plug disposed near its distal end adapted to en-
`gage and seal said lumen by contacting either the distal
`or proximal valve surfaces by sliding axially through
`the catheter lumen, and adapted to be introduced into
`the catheter body either through the proximal or distal
`ends.
`3. The catheter of claim 2 wherein the control wire is
`a guidewire having a proximal end and a distal tip.
`4. The catheter of claim 3 wherein the guidewire
`additionally comprises a bendable guide tip at its distal
`tip.
`5. The catheter of claim 2 wherein the inflatable bal-
`loon additionally comprises a balloon inner member
`allowing fluid communication between the lumen and
`the inflatable balloon and extending between the distal
`6. The catheter of claim 5 wherein the balloon inner
`member is additionally adapted to allow axial passage of
`the valve plug.
`7. The catheter of claim 6 wherein the balloon inner
`member comprises a coil.
`8. The catheter of claim 6 wherein the balloon inner
`member comprises perforated tubing.
`9. The catheter of claim 8 wherein the balloon inner
`member additionally comprises a coil coaxially disposed
`about the perforated tubing.
`
`
`
`5,304,198
`
`8
`10. The catheter of claim 8 wherein the balloon inner
`member additionally comprises a braided or woven
`tubing coaxially disposed about the perforated tubing.
`11. The catheter of claim 6 wherein the balloon inner
`member comprises a braided or woven tubing.
`12. The catheter of claim 5 wherein the balloon inner
`member comprises a coil.
`13. The catheter of claim 5 wherein the balloon inner
`member comprises perforated tubing.
`14. The catheter of claim 13 wherein the balloon
`inner member additionally comprises a coil coaxially
`disposed about the perforated tubing.
`15. The catheter of claim 13 wherein the balloon
`inner member additionally comprises a braided or
`woven tubing coaxially disposed about the perforated
`tubing.
`16. The catheter of claim 5 wherein the balloon inner
`member comprises a braided or woven tubing.
`17. The catheter of claim 2 wherein the ratio of the
`diameter of the balloon before inflation and the diame-
`ter of the balloon after inflation is less than lz6.
`18. The catheter of claim 2 wherein the diameter of
`the balloon before inflation is within 10% of the diame-
`ter of the catheter body proximal of the inflatable bal-
`loon.
`19. The catheter of claim 2 wherein the circumferen-
`tial band is radiopaque.
`20. The catheter of claim 2 wherein the valve plug is
`spherical.
`21. The catheter of claim 2 wherein the catheter body
`comprises a polyimide tubing coaxially surrounding a
`lubricious polymeric layer.
`22. The catheter of claim 21 wherein the lubricious
`polymeric layer comprises a fluoroethylene polymer.
`23. The catheter of claim 22 wherein the fluoroethyl-
`ene polymer is selected from polytetrafluoroethylene,
`fluoroethylene copolymers having perfluoroalkoxy
`groups, copolymers of tetrafluoroethylene and hexa-
`fluoropropylene, and copolymers of ethylene and tetra-
`fluoroethylene.
`24. The catheter of claim 23 wherein the fluoroethyl-
`ene polymer is a copolymer of tetrafluoroethylene and
`hexafluoropropylene.i
`l
`t
`t
`t
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`65
`
`
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1022 - Page 7
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1022 - Page 7
`
`