United States Patent
`Sugiyama et aL
`
`[19]
`
`[11] Patent Number:
`[45] Date of Patent:
`
`4, 994, 032
`Feb. 19, 1991
`
`[54] BALLOON CATHETER
`
`[75]
`
`Inventors: Yoshiaki Sugiyama; Kyuta Sagae;
`Susumu Tanabe, all of Fuji, Japan
`
`[73] Assignee:
`
`Terumo Kabushiki Kaisha, Tokyo,
`Japan
`
`[21] Appl. No. : 277, 564
`
`[22] Filed:
`
`Nov. 29, 1988
`
`Foreign Application Priority Data
`[30]
`Japan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62-303930
`Dec. 1, 1987 [JP]
`
`[51] Int. CLs .
`[52] U. S. Cl.
`
`[58] Field of Search
`
`A61M 25/10
`604/96; 604/288;
`606/194
`. . . . . . . . . . . . . . . . . . . . . . . 604/96-103,
`604/282, 192-196; 128/344
`
`3a
`
`6
`
`8
`
`[56]
`
`References Cited
`U. S. PATENT DOCUMENTS
`4, 571, 240 2/1986 Samson et a!. . . . . .
`. . . . 604/96
`. . . . 604/96
`4, 597, 755 7/1986 Samson et al. . . . . .
`4, 646, 719 3/1987 Neumann et ai. . .
`. . 128/344
`. . . . 604/96
`4, 782, 834 11/1988 Maguire et al. . . . .
`Primary Examiner — Stephen C. Pellegrino
`Attorney, Agent, or Firm — Frishauf, Holtz, Goodman &
`Woodward
`
`ABSTRACT
`[57]
`There is provided a balloon catheter comprising a tubu-
`lar body including at least one lumen, and a foldable
`balloon provided at a predetermined
`distal portion on
`the outer surface of said tubular body so that the balloon
`communicates with at least one lumen
`in said tubular
`is provided at a predeter-
`body, wherein reinforcement
`mined portion on the outer surface of said tubular body
`surrounded by said balloon. The reinforcement
`is pref-
`erably formed on an X-ray opague material and in the
`form of a coil.
`
`13 Claims, 7 Drawing Sheets
`
`l0
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1009 Page 1
`
`

`

`U. S. Patent
`
`Feb. 19, 1991
`
`Sheet 1 of 7
`
`4, 994, 032
`
`3a
`
`IIq
`
`2
`
`3
`
`1
`
`7
`
`4
`
`1a
`
`FIG. 2
`
`14
`
`4
`
`1
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1009 Page 2
`
`

`

`U. S. Patent
`
`Feb. 19, 1991
`
`Sheet 2 of 7
`
`4, 994, 032
`
`F I G. 4
`
`22
`
`4 1
`
`12
`
`13
`
`F I G. 5
`
`20
`
`15
`
`13
`
`24
`
`3
`
`15
`
`g
`
`1a
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1009 Page 3
`
`

`

`U. S. Patent
`
`Feb. 19, 1991
`
`Sheet 3 of 7
`
`4, 994, 032
`
`F I G. 6
`
`29
`
`30
`
`28
`
`27
`
`26
`
`25
`
`F I G. 7
`30
`
`26
`
`31
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1009 Page 4
`
`

`

`U. S. Patent
`
`Feb. 19, 1991
`
`Sheet 4 of 7
`
`4, 994, 032
`
`F I G. 8
`10
`
`26
`
`15
`
`32
`
`30
`
`F I G. 9
`
`10
`
`30
`
`g
`
`1
`
`15
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1009 Page 5
`
`

`

`U. S. Patent
`
`Feb. 19, 1991
`
`Sheet 5 of 7
`
`4, 994, 032
`
`F I Q. 10
`
`10
`
`'14
`
`30
`
`1
`
`15
`
`3'
`
`6'
`
`5'
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1009 Page 6
`
`

`

`U. S. Patent
`
`Feb. 19, 1991
`
`Sheet 6 of 7
`
`4, 994, 032
`
`F I G. 12
`3l ~
`
`14
`
`10
`
`6
`
`5 34
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1009 Page 7
`
`

`

`U. S. Patent
`
`Feb. 19, 1991
`
`Sheet 7 of 7
`
`4, 994, 032
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1009 Page 8
`
`

`

`4, 994, 032
`
`35
`
`BALLOON CATHETER
`
`BACKGROUND OF THE INVENTION
`l. Field of the Invention
`to a balloon catheter. More
`relates
`This invention
`it relates to a balloon catheter for expand-
`particularly,
`ing and thereby remedying stenosis in a blood vessel for
`the state of the distal side blood stream.
`improving
`2. Description of the Prior Art
`In the event of stenosis or obturations
`in the vascular
`transuminal
`system, such as blood vessels, percutaneous
`coro-
`(PTA) or percutaneous
`transluminal
`angioplasty
`(PTCA) is performed for enlarging or
`nary angioplasty
`the narrowed or obturated site of the vas-
`recanalizing
`cular system to thereby improve the body liquid stream
`the distal side of the vascular system. In PTA
`towards
`or PTCA, after a blood vessel is procured percutane-
`the vessel. A
`ously, a fine guide wire is passed through
`catheter having an end balloon (expandable member)
`is
`into the vessel, using this guide wire as the
`introduced
`guide, until the balloon is positioned at the site of lesion
`where stenosis or obturation has occurred. A liquid
`into
`is injected continuously
`such as contrast medium
`the balloon via an end hub under a pressure of several to
`the
`towards
`the balloon
`for dilating
`ten atmospheres
`inner wall of the blood vessel for pressuring and thereby
`the narrowed or obturated sites.
`enlarging
`in PTA or PTCA,
`As a balloon catheter employed
`there is known a balloon catheter having a coaxial dual
`tube system including an inner tube opened at one end
`and defining a first lumen and an outer tube surrounding
`the inner tube, forming a second lumen with the inner
`tube and provided with a distal balloon, or one in which
`is provided with a
`a tubular member defining a lumen
`the end of the tubular mem-
`distal balloon surrounding
`ber.
`In the case of the former balloon catheter having
`the
`formed of an
`ring markers
`tube system,
`coaxial dual
`X-ray opaque material are provided at predetermined
`that are sub-
`portions of the inner
`tube in the balloon
`in register with both ends of the balloon. ,
`stantially
`these ring markers being used as means for identifying
`the cylindrical portion of the balloon under X-ray fluo-
`that the balloon cathe-
`roscopy. However, considering
`the inside of the blood
`ter is caused to proceed through
`vessel presenting acute bend or bends, the risk is high
`the balloon at the
`tube disposed within
`that the inner
`the
`bends of the blood vessel be broken and collapsed
`lumen opened at one end the lumen opened at one end
`to obstruct smooth progress of the guide wire.
`there is also
`For overcoming
`the above difficulties,
`in which a piping having at
`known a balloon catheter
`both ends thereof prescribed portions substantially
`in
`register with both ends of the cylindrical portion of the
`tube disposed within
`is provided on the inner
`balloon
`the balloon. While it is possible with this known balloon
`tube from being broken
`to prevent
`the inner
`catheter
`it is difficult for the balloon catheter to
`and collapsed,
`the inside of the blood vessel present-
`proceed through
`that the bal-
`ing acute bend or bends. Even supposing
`in proceeding
`should have succeeded
`loon catheter
`beyond the bend, the risk is high that the piping remains
`thereof the blood vessel
`bent to obstruct
`the progress
`the distal side of the vascular
`beyond the bend towards
`systenl.
`
`OBJECT AND SUMMARY OF THE INVENTION
`It is a principal object of the present
`to
`invention
`provide a balloon catheter which is free from the above
`is able to prevent
`problems of the prior art and which
`breaking of the inner tube and obstructing of the lumen
`in blood vessels presenting an acute bend or bends.
`there is provided
`According to the present invention,
`a balloon catheter comprising a tubular body including
`10 at least one lumen, and a foldable balloon provided at a
`forward portion on the outer surface of
`predetermined
`the balloon communicates
`tubular body so that
`said
`in said tubular body, wherein
`with at least one lumen
`is pro-
`resides in that a reinforcement
`15 the improvement
`vided at a predetermined portion on the outer surface of
`said tubular body surrounded by said balloon
`the diameter of a
`According to the present invention,
`into
`portion of the balloon catheter which is introduced
`20 the patient's body and which is formed by said tubular
`is not more than 2. 7 mm.
`body and the folded balloon
`that the reinforcement be formed of an
`It is preferred
`X-ray opaque material.
`that the X-ray opaque material be plati-
`It is preferred
`25 num, gold, tungstene or alloys thereof.
`that the opaque material be a silverpal-
`It is preferred
`ladium alloy.
`that the reinforcement be a wire in the
`It is preferred
`form of a coil and having a circular, rectangular or an
`elliptical cross-section.
`that the wire of the coil is formed
`It is also preferred
`thereof
`in intimate and
`turns
`by a coil spring having
`tight contact with one another.
`turns of the coil spring may be ar-
`Alternatively,
`ranged thick in both end parts and thin in the intemedi-
`ate part of the coil spring.
`the portions of
`invention,
`to the present
`According
`the balloon catheter surrounded by the balloon may be
`from being broken and collapsed, even when
`40 prevented
`the inside of the
`through
`is proceeding
`the catheter
`blood vessel presenting acute bend or bends, so that the
`to the site
`balloon catheter can be prceeded positively
`of lesion in the blood vessel.
`BRIEF DESCRIPTION OF THE DRAWINGS
`invention will now be described with
`The present
`in which
`reference to the accompanying drawings
`FIG. 1 is an enlarged
`sectional view showing
`distal end part of the balloon catheter according
`preferred embodiment of the present
`invention,
`FIG. 2 is a sectional view taken along line II — II of
`FIG. 1,
`FIG. 3 is a sectional view taken along line III — III of
`FIG. 1,
`FIG. 4 is a diagrammatic view showing
`the proximal
`in FIG. 1,
`end part of the balloon catheter shown
`FIG. 5 is an overall side view showing
`the balloon
`catheter of FIG. 1, with a portion thereof being broken
`away,
`FIGS. 6 to 10 are diagrammatic views for illustrating
`in FIG. 1,
`the operation of the balloon catheter shown
`FIGS. 11 and 12 are enlarged sectional views show-
`ing the distal end part of balloon catheters according to
`modified embodiments of the present
`invention; and
`FIG. 13 shows a modification of the embodiment of
`FIG. 1.
`
`the
`to a
`
`45
`
`50
`
`55
`
`60
`
`65
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1009 Page 9
`
`

`

`DESCRIPTION OF PREFERRED
`EMBODIMENTS
`to the accompanying drawings, certain
`By referring
`of a balloon catheter of the
`embodiments
`preferred
`including a tubular member having
`invention
`present
`in detail.
`two lumens will be explained hereinbelow
`FIGS. 1 to 4 illustrate a preferred embodiment of the
`invention.
`to the present
`balloon catheter according
`FIG. 1 is an enlarged sectional view showing
`the distal
`side of the balloon catheter. FIGS. 2 and 3 are sectional
`views taken along line II — II and line III — III of FIG. 1,
`respectively. FIG. 4 is an enlarged sectional view show-
`ing the proximal side of the balloon catheter.
`in FIGS. 1 to 4, the balloon catheter 10 of
`As shown
`includes an inner tube 1 having a
`invention
`the present
`first lumen opened at one end, an outer tube 2 provided
`the inner tube 1 at a position set back a
`for encircling
`distance from a foremost part la of the
`predetermined
`inner tube 1 and defining a second lumen 6 between
`it
`and the outer surface of the inner tube 1, and a balloon
`to the inner tube 1
`3 including a distal end 7 attached
`to the outer tube 2. The
`and a proximal end 8 attached
`balloon 3 communicates with the second lumen
`in the
`vicinity of the proximal end 8. and has a cylindrical
`thereof
`section 3a, can be including at least a portion
`to permit a con-
`in contour
`cylindrical
`substantially
`stricted site of the blood vessel to be dilated easily. A
`reinforcement 9 is wound about a portion on the outer
`surface of the inner
`is substan-
`tube which
`peripheral
`tially in register with the cylindrical section 3a.
`The balloon catheter 10 has the inner tube 1 and the
`tube or tubular body or
`tube 2 as a cathether
`outer
`member 5, the proximal end of which is provided with
`in FIG. 4. The
`a bifurcated branched hub 20, as shown
`branched hub 20 has a guide wire port 12 and an injec-
`tion port 13 communicating with the first lumen 4 and
`with the second lumen 6, respectively.
`The first lumen 4 formed by the inner tube 1 plays the
`role of a guide wire passage and a blood route or chan-
`nel during use of the balloon catheter. The first lumen
`at its proximal end with the guide wire
`communicates
`port 12 formed in the branched hub 20, such that a guide
`wire 15 for the balloon catheter as later described
`is
`into an opening end of the guide wire port
`introduced
`12 so as to be guided into the first lumen 4.
`formed of a material
`The inner tube 1 is preferably
`including polyolefins, such
`exhibiting certain flexibility,
`ethylene-propylene
`as polyethylene,
`polypropylene,
`ther-
`copolymers or ethylene-vinyl
`acetate copolymers,
`moplastic resins, such as polyvinyl chloride, polyamide
`silicone rubber or latex
`elastomers or polyurethane,
`thermo-
`rubber. More preferred are the aforementioned
`plastic resins and most preferred are polyolefins.
`The outer tube 2, in the inside of which the inner tube
`is preferably mounted coaxially with
`1 is introduced,
`the inner tube 1 and at a position in which the foremost
`part of the outer tube is set back a small distance from
`tube 1. The second
`the foremost part la of the inner
`the inner surface of the
`lumen 6 is defined between
`outer tube 2 and the outer surface of the inner tube 1.
`the role of a channel
`for
`The second
`lumen 6 plays
`injection of, for example, contrast medium and dischag-
`ing of residual air and communicates at its proximal end
`with the injection port 13 of the branched hub 20. The
`second lumen 6 also communicates at its distal end with
`the inside of the balloon 3 at its rear end. The contrast
`medium, for example, are injected and charged into the
`
`4, 994, 032
`internal space of the balloon 3 via the opening end of
`the injection port 13 and the second lumen 6 while the
`residual air is discharged simultaneously.
`formed of a material
`The outer tube 2 is preferably
`including polyolefins, such
`exhibiting certain fexibility,
`ethylene-propylene
`polypropylene,
`as polyethylene,
`ther-
`acetate copolymers,
`copolymers or ethylene-vinyl
`moplastic resins, such as polyvinyl chloride, polyamide
`rubber or latex
`silicone
`elastomers or polyurethane,
`thermo-
`tP rubber. More preferred are the aforementioned
`plastic resins and most preferred are polyolefins.
`The balloon 3 has its foremost part 7 and rear end 8
`surface of the foremost
`secured to the outer peripheral
`part of the inner
`tube 1 and to the outer peripheral
`l5 surface of the foremost part of the outer tube 2 liquid-
`as with an adhesive or by heat
`respectively,
`tightly,
`fusion, for delimiting an expansion space 14 between the
`inner surface of the balloon 3 and the outer surface of
`the inner tube 1. This expansion space 14 communicates
`at its rear end with the second lumen 6 along its overall
`for example,
`so that the contrast medium,
`periphery
`may be charged into the space 14 via the second lumen
`6, as described hereinabove.
`The balloon 3 may be folded in such a manner
`that,
`it may be folded and
`is not dilated,
`the balloon
`when
`wrapped about the outer periphery of the inner tube 1.
`In order that the constricted site of the blood vessel may
`be dilated more easily, at least a portion of the balloon
`cylinder for
`3p 3 is formed as a substantially
`equidiametral
`cylindrical section 3a. The
`the aforementioned
`defining
`cylindrical section need not be a true cylinder but may
`be in the form of a prism having a polygonal cross-sec-
`tion.
`It should be noted that the balloon 3 is tapered from
`side of the cylindrical
`section 3a to the
`the forward
`foremost part 7 where it is secured to the inner tube 1
`section 3a to
`and from the rear side of the cylindrical
`the rear end 8 where it is secured to the outer tube 2.
`It should also be noted that, in the state in which the
`balloon 3 is folded and wrapped about the inner tube 1,
`that is, the balloon 3 is wrapped around
`the catheter
`tube 5, the portion of the balloon catheter
`introduced
`into the patient's body be of an outside diameter of not
`45 more than 2. 7 mm at the maximum,
`since the balloon
`in such case in the
`catheter can be used satisfactorily
`body cavity, above all, in a finer vasculum.
`formed of a material ex-
`The balloon 3 is preferably
`including polyolefins, such as
`hibiting certain flexibility,
`co-
`ethylene-propylene
`polypropylene,
`5p polyethylene,
`acetate copolymers or cross-
`polymers, ethylene-vinyl
`thermoplastic
`acetate copolymer,
`linked ethylene-vinyl
`resins, such as polyvinyl chloride, polyamide elastomers
`silicone rubber or latex rubber. More
`or polyurethane,
`thermoplastic
`resins
`55 preferred are the aforementioned
`and most preferred are the cross-linked ethlene-vinyl
`acetate copolymers.
`invention, a reinforcement
`to the present
`According
`portion of the outer
`9 is wound about a predetermined
`6p surface of the inner tube 1 which is enclosed within
`the
`the portion thereof in register with
`balloon 3, preferably
`section 3a. With
`the
`cylindrical
`the aforementioned
`reinforcement 9 thus wound about the inner tube 1, the
`inner tube is rendered more resistant against buckling,
`65 so that there is no risk that the inner tube 1 disposed
`in
`the balloon 3 be broken or the first lumen 4 through
`the guide wire 15 for the balloon catheter
`which
`is
`passed be broken even at a bend of the blood vessel.
`
`35
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1009 Page 10
`
`

`

`4, 994, 032
`
`IP
`
`The reinforcement 9 is preferably formed of an X-ray
`opague material, preferably platinum, gold, tungsten or
`alloys thereof and more preferably a silver-palladium
`alloy, since a clear contrast image can then be obtained
`under X-ray fluoroscopy and thus the cylindrical sec-
`tion 3a of the balloon 3 can be identified more easily.
`The reinforcement 9 is preferably a wire wound
`into
`the inner
`a coil. By using the coil as the reinforcement,
`tube 1 can be reinforced more strongly against buckling.
`The wire of the coil preferably has a circular, rectan-
`rein-
`for inceasing
`gular or an elliptical cross-section
`forcing effects.
`The wire in the form of a coil may preferably be a
`intimate
`its turns are
`spring coil so wound
`that
`in
`contact with one another. With this dense winding of
`the wire, the inner tube can be reinforced more strongly
`against buckling.
`The branched hub 20 is formed by an inner tube hub
`22 and an outer tube hub 23. The inner
`tube hub 22
`communicates with the first lumen 4, has a guide wire
`port 12 through which the guide wire 15 for the balloon
`catheter is introduced, and is secured to the inner tube 1.
`The outer tube hub 23 communicates with the second
`lumen 6, has an injection port 13 for injecting contrast
`medium, for example, and is secured to the outer tube 2.
`The outer tube hub 23 and the inner tube hub 22 are
`secured to each other.
`The branched hub 20 is preferably formed of thermo-
`plastic resins, such as, for example, polycarbonate, poly- 3p
`polyallylate or methacrylatebuty-
`amide, polysulfone,
`lene-stylene copolymers.
`the operation of the balloon catheter
`For explaining
`in FIGS. 1 to 4, the
`of the present
`shown
`invention
`method of using
`the balloon catheter
`in angioplasty
`to
`(PTA or PCTA) will be explained by referring
`FIGS. 5 to 10.
`to angioplasty
`It is preferred
`that, before conducting
`by dilating and remedying constrictions occurred in the
`blood vessel, as much air as possible be removed
`from 4p
`the inside of the balloon catheter. To this end, suction
`filled with
`and injection means, such as a in-deflator,
`is attached to the injection port 13 of
`contrast mediaum
`the catheter and the operation of alternate injection and
`to remove the air in the 45
`suction is repeatedly performed
`second lumen 6 and the balloon 3 to replace it with the
`contrast medium.
`When the expansion space 14 of the balloon 3 and a
`space of the second lumen 6 is filled with the contrast
`medium and the residual air is removed completely, a 50
`amount of the contrast medium
`filled in
`predetermined
`the expansion space 14 is sucked and discharged by an
`injector fitted with a pressure gauge 24 to cause the
`balloon 3 to be wound about the inner tube 1 of the
`tubular member 5 to reduce the outside diameter of the 55
`balloon 3 so that the outside diameter of the portion of
`into the patient' s
`the balloon catheter 10 introduced
`body is not more than 2. 7 mm, in order to make ready
`for insertion of the balloon catheter into the blood ves-
`sel in angioplasty.
`For angioplasty, a blood vessel 30 is procured,
`that is,
`peirced with the dilater and sheath 25 as shown in FIG.
`the Sheath method. A
`6( by relying upon, for example,
`guiding catheter indwelled gauide wire is prepared. A
`into the blood vessel 65
`guiding catheter 26 is introduced
`30 along the guide wire and left at an inlet 31 to the
`coronary artery having a target lesion. The guide wire
`for the guide catheter is then removed.
`
`The balloon catheter guide wire 15 is then introduced
`at the guide wire port 12 of the balloon catheter 10 into
`the inner tube 1 of the tubular member 5, that is, into the
`several
`first lumen 4, until the guide wire is protruded
`centimeters beyond the end opening la of the inner tube
`in FIG. 5. The resulting assembly
`is then
`1, as indicated
`into the guiding catheter 26 via a balloon
`introduced
`catheter port 28 of a Y-shaped connector 27, to the
`proximal end of which the guiding catheter 26 is con-
`in FIG. 6. The balloon catheter 10 is
`nected, as shown
`the inside of the guiding cathe-
`then proceeded through
`ter 26 so as to be proceeded via the forward end of the
`guiding catheter 26 into the blood vessel 30 having
`the
`target lesion 30.
`The balloon catheter guide wire 15 is then extended
`the inside of the blood ves-
`to the target lesion through
`in FIG. 8. The guide wire 15 is left in
`sel 30, as shown
`the con-
`through
`the blood vessel after it has passed
`stricted site 32.
`the
`The balloon catheter 10 is then advanced
`through
`inside of the blood vessel 30 along the balloon catheter
`guide wire 15. The balloon catheter 10 of the present
`resistance against bending
`invention has an increased
`since the reinforcement 9 is wound about the portion of
`the outer surface of the inner tube 1 disposed within
`the
`balloon 3, so that, even when the blood vessel 30 has an
`in FIG. 8, there is no risk of ob-
`acute bend, as shown
`struction of the progress of the balloon catheter guide
`wire 15 caused by the breaking of the inner
`tube 1
`the balloon 3 or the collapse of the first lumen
`within
`opened at the end and hence the balloon catheter 10 can
`the lesion at the distal
`towards
`be proceeded smoothly
`side.
`It should be noted that, when the reinforcement 9 is
`formed as a wire in the form of a coil, above all, as a coil
`spring, which is wound about the outer surface of the
`turns of the coil in
`tube 1 with the neighboring
`inner
`in-
`intimate contact with one another,
`an
`tight and
`is obtained against external forces.
`creased resistance
`When the coil wire has an elliptical, rectangular or a
`is obtained
`increase
`circular cross-section, a further
`in
`the resistance against external forces.
`Also, when the reinforcement 9 is formed of an X-ray
`the reinforcement 9 is indicated as a
`opague material,
`image, under X-ray fluoroscopy,
`clear X-ray contrast
`such that this reinforcement 9 can be checked visually
`as an indicia for the balloon for positively positioning
`the cylindrical section 3a of the balloon 3 at the stenosis
`site 32.
`It is preferred that the X-ray opague material be plati-
`thereof or a silverpal-
`alloys
`tungstene,
`num, gold,
`ladium alloy, since then a clearer X-ray contrast image
`the reinforcement may be used
`is produced and thus
`more effectively as the indicia for the balloon 3.
`in the state in which
`the
`It is also preferred
`that,
`balloon 3 is folded and wrapped about the inner tube 1,
`that is, about the tubular member 5, the portion of the
`into the patient's body be of
`balloon catheter introduced
`an outside diameter of not more than 2. 7 mm, since then
`the balloon catheter can be used more advantageously
`the vessel
`the body cavity, above all, within
`within
`inner cavity.
`having a narrower
`the balloon 3 reaches
`the stenosis site 32, as
`When
`shown in FIG. 9, the contrast medium are injected into
`the dilated space 14 of the balloon 3, as the contrast
`to several to ten and odds atmo-
`medium are pressurized
`spheres, by the injector fitted with a pressure gauge 24,
`connected to the injection port 13 of the balloon cathe-
`
`35
`
`60
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1009 Page 11
`
`

`

`4, 994, 032
`
`space 14' of the
`into the expansion
`amount
`termined
`balloon 3', with the aid of the pressure gauge-injector
`the balloon 3' for pressuring and enlarg-
`24, for dilating
`ing the stenosis 32.
`5 When it is observed that the state of the blood stream
`the balloon catheter 10' may be removed
`is improved,
`from the inside of the blood vessel, as described herein-
`above.
`the
`In the present second embodiment, by providing
`&0 reinforcement 9 at the forward side of the tubular mem-
`ber 5', the tubular member can be reinforced against
`buckling.
`
`25
`
`&0
`
`the balloon 3 as shown in FIG. 10
`ter 10, for expanding
`the diameter of the stenosis
`for pressuring and enlarging
`site 32.
`After termination of this operation,
`the contrast me-
`into the blood vessel via contrast
`dium are injected
`injection port 29 of the Y-shaped connector 27
`medium
`to the proximal end of the guiding catheter
`connected
`26 for visual checking of the distal side blood stream by
`that the blood
`X-ray fluoroscopy. When it is observed
`the balloon catheter 10 and
`the
`is improved,
`stream
`balloon catheter guide wire 15 are removed
`from the
`blood vessel 30. The guiding catheter 26 is then re-
`moved and the pierced portion of the blood vessel is
`the opera-
`to terminate
`pressed to stop the hemorrhage
`tion.
`The above described balloon catheter
`is formed by
`two
`inner and outer tubes defining
`coaxially arranged
`invention may naturally
`the present
`lumens. However,
`to a balloon catheter formed by a tubular
`be applied
`member defining a sole lumen.
`Referring to FIG. 11, showing a second embodiment
`of the present invention, a balloon 3' enclosing the distal
`part of a tubular member 5' is provided at the distal part
`of the tubular member 5' defining the sole lumen 6'. The
`reinforcement 9 may be provided at the distal part of
`the tubular member 5' surrounded by the balloon 3' for
`forming a balloon catheter 10'.
`This balloon catheter 10' is used for improving
`the
`state of stenosis of the coronary artery, for example.
`The operation of the balloon catheter 10' is basically the
`same as that of the above described balloon catheter 10
`in the present
`having the dual tube structure. However,
`the balloon catheter guide wire 15 is intro-
`embodiment,
`duced into the lumen 6' at its proximal end and held so
`that its distal part does not break the balloon 3'. In this
`the balloon 3' is replaced by the
`state, the air inside
`in the same way as in the preceding
`contrast medium
`embodiment. The contrast medium are then sucked and
`amount using the afore-
`in a predetermined
`discharged
`to cause the balloon 3' to be
`in-deflator
`mentioned
`the tubular member 5' to reduce
`the
`about
`wrapped
`outside diameter of the balloon 3' so that the outside
`diameter of the portion
`the balloon
`into
`introduced
`catheter 10' is not more than 2. 7 mm.
`Referring to FIG. 12, illustrating a third embodiment
`of the present invention, a tubular member 5" defining a
`sole lumen 6" has a distal closed end. At the distal part
`of the tubular member 5" is provided a balloon 3" en-
`closing the distal part of the tubular member 5". The
`lumen 6" of the tubular member 5" may be in fluid
`space 14" of the
`communication with an expansion
`balloon 3" through an orifice or orifices formed
`in the
`tubular member 5". The reinforcement 9 may be pro-
`vided at the distal part of the tubular member 5" sur-
`rounded by the balloon 3" and have
`therof so
`turns
`wound that they be in intimate contact with each other.
`The operation of this balloon catheter
`is substantially
`same as those of the above-discribed balloon catheters.
`In case of the reinforcement being a coil spring,
`it
`that its turns are thick
`may alternatively be so wound
`in intimate contact with each other in both
`for example
`end parts and thin or sparse in the intermediate part of
`the coil spring.
`into
`in this state is introduced
`The balloon catheter
`the blood vessel 30, as it is guided by the balloon cathe-
`ter guide wire 15, until the balloon 3' reaches the steno-
`sis site 32 in the same way as in the preceding embodi-
`ment. The contrast medium are then injected in a prede-
`
`EFFECT OF THE INVENTION
`in detail, the present invention provides
`As described
`a balloon catheter comprising a tubular body including
`at least one lumen, and a foldable balloon provided at a
`predetermined distal portion on the outer surface of said
`tubular body so that the balloon communicates with at
`in said tubular body, wherein a rein-
`least one lumen
`forcement is provided at a predetermined portion on the
`outer surface of said tubular body surrounded by said
`balloon.
`With the above described arrangement of the balloon
`the balloon portion of the balloon catherter
`catherter,
`may positively be proceeded to the target lesion, with-
`out breaking and collapsing of the tube portion enclosed
`in the balloon even at progress through an acute bend of
`the blood vessel.
`What is claimed is:
`1. A balloon catheter, comprising:
`a tubular body including at least one lumen;
`a foldable balloon provided at a predetermined
`distal
`portion of said tubular body and surrounding
`the
`outer surface off said distal portion of said tubular
`body so that said balloon communicates with said
`at least one lumen of said tubular body;
`a coil spring provided at a predetermined
`portion on
`the outer surface of the portion of said
`tubular
`by said balloon, for reinforcing
`body surrounded
`said tubular body, said coil spring having opposite
`end portions and an intermediate portion, said coil
`spring being wound such that the turns thereof are
`in intimate contact with each other at both end
`portions thereof and are sparse in said intermediate
`portion thereof.
`2. The balloon catheter of claim 1, wherein
`the out-
`side diameter of a portion of the catheter to be intro-
`is formed by said
`into a patient's body which
`50 duced
`is not more than
`tubular body and said folded balloon
`2. 7 cm.
`3. The balloon catheter of claim 1, wherein said coil
`is formed of an X-ray opaque material.
`spring
`4. The balloon catheter of claim 3, wherein said X-ray
`is selected from the group consisting of
`opaque material
`platinum, gold, tungsten, and alloys thereof.
`5. The balloon catheter of claim 3, wherein said X-ray
`alloy.
`is a silver-palladium
`opaque material
`6. The balloon catheter of claim 1, wherein said coil
`spring is formed from a wire having a circular cross-sec-
`tion.
`7. The balloon catheter of claim 1, wherein said coil
`spring is formed from a wire having a rectangular cross-
`65 section.
`8. The balloon catheter of claim 1, wherein said coil
`spring is formed from a wire having a ellipsoidal cross-
`section.
`
`60
`
`45
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1009 Page 12
`
`

`

`4, 994, 032
`
`9. The balloon catheter of claim 1, wherein said tubu-
`lar body has at least two lumens.
`10. The balloon catheter of claim 9, wherein at least
`is open at said distal end of said
`one of said lumens
`tubular body.
`11. The balloon catheter of claim 1, wherein
`tubular body has a single lumen.
`12. The balloon catheter of claim 11, wherein
`
`said
`
`said
`
`10
`tubular member defining said single lumen
`its distal end.
`13. The balloon catheter of claim 11, wherein
`said
`is open at its
`tubular member defining said single lumen
`distal end.
`
`is closed at
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`45
`
`50
`
`55
`
`65
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1009 Page 13
`
`

`

`UNITED STATES PATENT AND TRADEMARK OFFICE
`CERTIFICATE OF CORRECTION
`4, 994, 032
`February 19, 1991
`Yoshiaki SUGIYAMA et al
`
`PATENT NO.
`
`DATED
`
`INVENTOR(S):
`
`It is certified that error appears in the above-identified patent and that said Letters Patent is hereby
`corrected as shown below:
`
`Column 5, line 11, Change "inceasing"
`to --increasing--.
`Column 5, line 64, Change "gauide"
`--guide--.
`to
`item [57] col. 2,
`Title page,
`line 9, Change "on" to --of--.
`In the Abstract,
`line 9, Change "opague"
`In the Abstract,
`to --opaque--.
`
`Signed and Sealed this
`Twenty-second Day of August, 1995
`
`Attest:
`
`Attesting officer
`
`Commissioner of Parents and Trademarks
`
`BRUCE LEHMAN
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1009 Page 14
`
`