United States Patent i
`4,964,853
`[11] Patent Number:
`Oct. 23, 1990
`[45] Date of Patent:
`Sugiyamaetal.
`
`[54] CATHETER EQUIPPED WITH EXPANSIBLE
`MEMBER
`
`[75]
`
`Inventors: Yoshiaki Sugiyama; Kyuta Sagae,
`both of Kanagawa, Japan
`
`[73] Assignee:
`
`Terumo Kabushiki Kaisha, Tokyo,
`Japan
`
`[21] Appl. No.:
`
`415,345
`
`[22] PCT Filed:
`
`Feb. 25, 1988
`
`[86]. PCT No.:
`
`PCT/JP88/00201
`
`§ 371. Date:
`
`Oct. 26, 1989
`
`§ 102(e) Date:
`
`Oct. 26, 1989
`
`[87] PCT Pub. No.: WO88/06464
`
`PCT Pub. Date: Sep. 7, 1988
`
`Foreign Application Priority Data
`[30]
`Feb. 27, 1987 [JP]
`JAPaMn.
`....csccccesscocscssereserreeseeee 62-46196
`[51]
`Tmt, C15 ocescesecenenseesseseeeeeenees A61M 25/00
`
`Se
`Cy
`ceteessssscscsssscessesessesecensncees 604/96; 604/102
`[58] Field of Search ..............004 604/96, 102, 93, 103,
`604/280, 264, 43-45
`
`[56]
`
`References Cited
`U.S. PATENT DOCUMENTS
`
`4,195,637 4/1980 Gruntzig et al.
`4,323,071
`4/1982 Simpsonet al.
`4,411,055 10/1983 Simpsonet al.
`
`.
`
`.
`.
`
`7/1986 Samson et al. .......ccssseccereee 604/96
`4,597,755
`4,752,286 6/1988 Okada..............
`-- 604/102 X
`
`4,762,129
`8/1988 Bonzel ......ssssscsseessesceeees 604/96 X
`4,892,099
`1/1990 Ohkawaet al. ou... 604/96 X
`
`Primary Examiner—John D. Yasko
`Attorney, Agent, or Firm—Frishauf, Holtz, Goodman &
`Woodward
`
`ABSTRACT
`-
`[57]
`A catheter equipped with an expansible member com-
`prising an inner tube having a first lumen whosetip is
`open and a second lumen extending to the tip direction
`ofthe first lumen; an outer tube disposed coaxially with
`the inner tube and havinga tip at a position recessed by
`a predetermined distance from thetip of the inner tube
`and forming a third lumen between it and the outer
`surface of the inner tube; a contractible or foldable
`expansible memberhaving a tip end portion and a base
`end portion, the base end portion being fitted to the
`outer tube and the tip end portion being fitted to the
`inner tube, the expansible member communicating with
`the second lumennear the tip end portion and with the
`third lumen near the base end portion; a first opening
`communicating with the first lumen and a second open-
`ing communicating with the second lumen each dis-
`posed at the base end portion of the inner tube; and a
`third opening disposed at the base end portion of the
`outer tube and communicating with the third lumen.
`
`2 Claims, 5 Drawing Sheets
`
`SS Sieaa Mahea BagSe ac Soe co MrsBnSageaa hgpo
`
`|epeeaSSECoSeeetelRRSEEeS CS
`
`
`
`—LS
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1011 - Page 1
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1011 - Page 1
`
`

`

`
`
`US. Patent—Oct. 23, 1990 Sheet 1 of 5 4,964,853
`
`
`
`FIG.
`
`1 z
`
`e=a an .
`
`dey
`wal
`So
`FOSeeeeESSSESOSSeSR wt
`—~—— ann”aaWS
`ASE SEES SEESE SE EEEE
`sos
`SSS
`
`
`
`
`
`
`
`
`
`
`14
`
`
`
`15
`
`|
`B
`
`A
`
`
`
`
`
`
`
`
`
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1011 - Page 2
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1011 - Page 2
`
`

`

`US. Patent
`
`Oct. 23, 1990
`
`Sheet 2 of 5
`
`4,964,853
`
`FIG, 3
`
`FIG. 4
`
`5
`
`aS
`
`1 SH
`
`
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1011 - Page 3
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1011 - Page 3
`
`

`

`US. Patent
`
`oct. 23, 1990
`
`Sheet3 of 5
`
`4,964,853
`
`FIG.6
`
`
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1011 - Page 4
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1011 - Page 4
`
`

`

`US. Patent
`
`Sheet4 of 5
`Oct. 23, 1990
`FIG. 7
`
`4,964,853
`
`30
`
`
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1011 - Page 5
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1011 - Page 5
`
`

`

`
`
`US. Patent—Oct. 23, 1990 Sheet 5 of 5 4,964,853
`
`
`
`FIG. 9
`
`
`
`
`
`ITNNSANSSSSAINSSSIASINASSAS SS
`YSSS
`
`
`ft
`
`[SSOe
`
`
`
`
` STNSSSSSS
`
`
`FIG. 10
`
`(TTSOSOSSSSSSSSASSASSSSSSSAN
`
`
`
`aee
`
`SSS
`
`
`
`
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1011 - Page 6
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1011 - Page 6
`
`

`

`1
`
`4,964,853
`
`2
`the expansible member and there is no worry of damag-
`ing the catheter or expansible member.
`DISCLOSURE OF THE INVENTION
`
`CATHETER EQUIPPED WITH EXPANSIBLE
`MEMBER
`
`DESCRIPTION
`
`A catheter equipped with an expansible member ac-
`cording -to the present invention comprises an inner
`1. Technical Field
`tube having a first lumen whosetip is open and a second
`This invention relates to a catheter equipped with an
`lumen extending to the tip direction ofthe first lumen;
`expansible memberfor use in curing a stricture portion
`an outer tube disposed coaxially with the inner tube and
`inside a blood vessel. Specifically, this invention relates
`having a tip at a position recessed by a predetermined
`to a catheter equipped with an expansible memberfor
`distance from the tip of the inner tube and forming a
`expandingastricture portion inside a blood vessel to .
`third lumen between it and the outer surface ofthe inner
`improve the blood flow on the peripheral side of the
`tube; a contractible or foldable expansible member hav-
`stricture portion.
`ing a tip end portion and a base end portion, the base
`2. Background Art
`end portion beingfitted to the outer tube andthe tip end
`Heretofore, as a catheter equipped with an expansible
`portion being fitted to the inner tube, the expansible
`member for expanding a stricture portion of a blood
`member communicating with the second lumen nearthe
`vessel,
`there has been so-called Gruentich type dis-
`tip end portion and with the third lumen near the base
`closed, for example, in U.S. Pat. No. 4,195,637. Further,
`end portion; a first opening communicating with the
`there has been used so-called Simpson-Robert
`type
`first lumen and a second opening communicating with
`disclosed, for example, in U.S. Pat. No. 4,323,071.
`the second lumen each disposed at the base end portion
`Previously, adaptible cases of vasodilatation were
`of the inner tube; and a third opening disposed at the
`limited to cases of locallized stricture near coronary
`base end portion of the outer tube and communicating
`artery from an anatomical viewpoint, which were le-
`with the third lumen.
`sions of about 15 to 20 mm length, monobranchedle-
`sions, non-calcified lesions, etc. In order to extend more
`the range of adaptible cases, as the above type catheter,
`a catheter equipped with an expansible memberof low-
`profile shape having the same structure but narrowed
`only at the tip has been considered in addition to those
`of standard structure to be adaptible to strictures in
`more peripheral blood vessel or severer strictures (sub-
`complete clogging).
`A catheter called Gruentich type as described above
`comprises a catheter tube having two lumens and an
`expansible memberattached near thetip of the catheter
`tube. One of the lumensis open atthe tip of the catheter
`to form a channel for a guide wire and for tip pressure
`measurement. Theotherof the lumensis in communica-
`tion with the inside of the expansible memberat the base
`end of the expansible member to form a flow channel
`for injecting fluid for expansion such as vasographic
`contrast liquid under pressure to expand the expansible
`member. In this catheter, it is difficult to remove bub-
`bles remaining within the expansible member when
`expanded by injecting vasographic contrast liquid or
`the like into the expansible member. If bubbles remain,
`X-ray image may become unclear and the remaining
`bubbles may enter the human bodyin the case that the
`expansible member is damaged from some cause.
`A catheter called Simpson-Robert type has a coaxial
`double-wall structure comprising an inner tube forming
`a firstomen whosetip is open, and an outer tube into
`which the inner tube is inserted andto the tip of which
`an expansible member is attached. A second lumen is
`formed between the inner surface of the outer tube and
`the outer surface of the inner tube. An ultrafine metal
`pipe is disposed in the second lumen for removing bub-
`bles. Although bubbles do not remain in the catheter of
`this type unlike those called Gruentich type as de-
`scribed above, because the metal pipeis used, the cathe-
`ter of this type has. little followabilty to the shape and
`movementof a blood vessel which is intensely curved.
`Further, the metal pipe inserted may injure or damage
`the inner wail of the catheter or expansible member.
`Accordingly, an object of the present invention is to
`provide a catheter equipped with an expansible member
`in which it is easy to remove bubbles from the inside of
`
`BRIEF EXPLANATION OF THE DRAWINGS
`FIG.1 is an enlarged cross sectional view of the tip
`end portion of one embodimentof a catheter equipped
`with an expansible member according to the present
`invention.
`FIG.2 is a view showing the base end portion of one
`embodiment of a catheter equipped with an expansible
`member according to the present invention.
`FIG.3 is a cross sectional view of the inner tube of
`the catheter equipped with the expansible member
`shown in FIG.1.
`FIG. 4 is a cross sectional view of the catheter
`equipped with the expansible member taken alongline
`A—A of FIG.1.
`FIG. 5 is a cross sectional view of the catheter
`equipped with the expansible member taken along line
`B—B of FIG.1.
`FIGS. 6, 7, 8, 9 and 10 are explanatory views for
`illustrating the operation of the catheter equipped with
`the expansible member according to the present inven-
`tion.
`
`15
`
`20
`
`25
`
`30
`
`35
`
`45
`
`55
`
`60
`
`65
`
`BEST MODE FOR PRACTICING THE
`INVENTION
`
`A catheter equipped with an expansible memberac-
`cording to the present invention will be described with
`reference to a preferred embodiment shown in the
`drawings.
`FIG.1 is an enlarged cross sectional view of the tip
`end portion of one embodiment ofa catheter equipped
`with an expansible member according to the present
`invention and FIG. 2 is a view showing the base end
`portion of the catheter.
`A catheter equipped with an expansible memberac-
`cording to the present. invention comprises an inner
`tube 1 having a first lumen 4 whose tip is open and a
`second lumen 5 extendingto the tip direction ofthefirst
`lumen; an outer tube 2 disposed coaxially with the inner
`tube 1 and havinga tip at a position recessed by a prede-
`termined distance from the tip of said inner tube and
`forming a third lumen 6 betweenit and the outer surface
`of the inner tube 1; a contractible or foldable expansible
`member 3 having a tip end portion 7 and a base end
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1011 - Page 7
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1011 - Page 7
`
`

`

`4,964,853
`
`35
`
`40
`
`45
`
`20
`
`4
`3
`member 13 is for preventing collapse of the catheter
`portion 8, the base end portion 8 being fitted to the
`main bodyat its bent portion and, further, improving
`outer tube 2 andthe tip end portion 7 beingfitted to the
`the torque transmission efficiency of the catheter main
`inner tube 1, said expansible member communicating
`body. By disposing the rigidity imparting member 13,
`with the second lumen 5 near the tip end portion and
`collapse of the catheter main body at its bent portion
`with the third lumen 6 near the base end portion;a first
`can be prevented and, further, the torque transmission
`opening 9 communicating with the first lumen 4 and a
`efficiency of the catheter main body can be improved
`second opening 10 communicating with the second
`and whenthe catheter main body is moved and rotated
`lumen 5 each disposed at the base end portion of the
`in a delicate fashion at the base end portion of the cathe-
`inner tube 1; and a third opening 11 disposed at the base
`end portion ofthe outer tube 2 and communicating with
`ter main body, the torque and the enforcing force can be
`the third lumen 6.
`surely transmitted to the tip portion of the catheter main
`Hereinafter, the explanation will be matle with refer-
`body,andthetip portion of the catheter main body and
`further the expansible member disposed on the tip por-
`ence to the drawings.
`A catheter equipped with an expansible memberac-
`tion can be easily introduced into a highly stricture
`cording to the present invention comprises a catheter
`portion in a blood vessel. The rigidity imparting mem-
`main bodyincluding an innertube 1, an outer tube 2 and
`ber 13 is preferably disposed at least from the base end
`an expansible member 3, and a branched hub 20.
`of the inner tube 1 to the vicinity of the tip portion of
`Theinner tube 1 hasafirst lumen 4 whosetip is open
`the outer tube 2. Therigidity imparting member may be
`and a second lumen 5 which is formed in parallel with
`disposed overthe entire length of the inner tube 1 for
`the first lumen 4 and whosetip is closed. Thefirst lumen
`improving the torque and force transmission efficien-
`4 is a lumen for inserting a guide wire therein and in
`cies. In the case of disposing the rigidity imparting
`communication with a first opening 9 which forms a
`member on the whole ofthe inner tube,it is preferable
`guide wire port disposed in the branched hub 20 de-
`that only the tip portion of the inner tubeis a portion in
`scribed later. The second lumen5 is a lumen for remov-
`which the rigidity imparting memberis not disposed so
`ing bubbles from the inside of the expansible member 3
`as to prevent the endofthe rigidity imparting member
`described later and in communication with the expansi-
`from protruding beyond the tip portion of the inner
`ble member 3 through a side hole 12. The rear end of
`tube. The end of the expansible member does not pro-
`the second lumen is in communication with a second
`trude beyondthetip of the inner tube and the inner wall
`opening 10 which forms a vent port disposed in the
`of a blood vessel can be prevented from being damaged.
`branched hub 20. The shape of the tip portion of the
`The rigidity imparting member 13 is preferably a
`second lumenis notlimited to that of the closed end as
`mesh-like rigidity imparting member. The mesh-like
`shown in FIG. 1 but may be, for example, a shape in
`rigidity imparting memberis preferably a braided mem-
`which the tip of the second lumenis bent to the direc-
`ber made of a wire material, particularly a metal wire.
`tion of the inside of the expansible member. The second
`As the metal wire, there is suitably used a metal wire
`lumen5 is formed in the inner wall of the inner tube 1 as
`madeof, for example,stainless steel, elastic metal, super
`shown in FIG. 1 and FIG.3 whichis a cross section of
`elastic alloy, shape memoryalloy, etc. of the wire diam-
`the inner tube, and has the inner diameter smaller than
`eter of 0.01 to 0.2 mm, preferably 0.03 to 0.1 mm. The
`the first lumen.
`mesh-like rigidity imparting member can be formed by
`Theinnertube 1 has the outer diameter of 0.50 to 2.50
`winding such a metal wire as described above on the
`mm, preferably 0.55 to 2.40 mm. The inner diameter of
`outer surface of the inner tube 1 in a mesh-like manner.
`the first lumenis 0.25 to 1.60 mm, preferably 0.30 to 1.50
`Further, the rigidity imparting member formed on the
`mm. The inner diameter of the second lumenis 0.03 to
`outer surface of the inner tube 1 is preferably embedded
`0.20 mm, preferably 0.04 to 0.15 mm. The shape of the
`in the outer wall of the inner tube 1 to make the outer
`cross section of each of the first and second lumensis
`surface smooth. This measure can be taken place by
`not limited to circle.
`forming an inner tube 1 with a thermoplastic resin, and
`The diameter of the tip portion of the inner tube 1 is
`after winding the rigidity imparting member described
`preferably reduced in a tapered shape towardthetip. In
`above, heating the inner tube 1 from the outside (for
`the embodiment shown in FIG. 1, the diameter of the
`example, by inserting the inner tube into a heating dice)
`tip portion of the inner tube 1 is taperingly reduced at a
`and embedding the rigidity imparting member in the
`thick portion at which the second lumen 5 is formed.
`outer wall of the inner tube.
`:
`The reason thereofis that such a taper makes the cathe-
`Therigidity imparting memberis not limited to metal
`ter easy to be inserted into a stricture portion in a blood
`wire but may be formed by the mannerthat a synthetic
`vessel.
`fiber such as a polyamidefiber, a polyester fiber and a
`The second lumen may not be formed within the
`polypropylene fiber is wound on the outer surface of
`thickness of the inner tube. For example, a tube body
`the inner tube 1.
`forming the second lumen may be mountedto the outer
`The outer tube 2 into which the inner tube 1 is in-
`surface of a tube body having the first lumen to form an
`serted has a tip slightly recessed by a predetermined
`inner tube.
`distance from the tip of the inner tube. As shown in
`The material for forming the inner tube 1 preferably
`FIG.4 whichis a cross section taken along line A—A
`has a certain extentof flexibility. For example, there are
`in FIG.1, a third lumen6 is formed by the inner surface
`usable thermoplastic resin such as polyolefin such as
`of the outer tube 2 and the outer surface of the inner
`polyethylene, polypropylene, ethylene-propylene co-
`tube 1. Thus, the third lumen is a lumen havinga suffi-
`polymer and ethylene-vinyl acetete copolymer, polyvi-
`cient volume. Thetip of the third lumen 6 is in commu-
`nyl chloride, polyamide elastomer and polyurethane;
`nication with the rear end portion of the inside of the
`silicone rubber,
`latex rubber, etc. The thermoplastic
`expansible member3. The-rear end of the third lumen 6
`resin is preferable and the polyolefin is more preferable.
`is in communication with a third opening 11 of the
`Further, the inner tube 1 is preferably provided with
`branched hub 20 forming an injection port for injecting
`a rigidity imparting member13. Therigidity imparting
`
`60
`
`65
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1011 - Page 8
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1011 - Page 8
`
`

`

`4,964,853
`
`0
`
`40
`
`45
`
`20
`
`6
`5
`The material for forming the expansible member 3
`fluid for expanding the expansible member (for exam-
`preferably has a certain extent of flexibility. For exam-
`ple, vasographic contrast liquid).
`ple, there are usable thermoplastic resin such as polyole-
`The material for forming the outer tube 2 preferably
`fin such as polyethylene, ethylene-propylene copoly-
`has a certain extentofflexibility. For example, there are
`mer, ethylene-viny] acetete copolymer and cross-linked
`usable thermoplastic resin such as polyolefin such as
`ethylene-vinyl acetete copolymer, polyvinyl chloride,
`polyethylene, polypropylene, ethylene-propylene co-
`polyamide elastomer, polyester and polyurethane; sili-
`polymer and ethylene-vinyl acetete copolymer, polyvi-
`cone rubber, latex rubber, etc. The above thermoplastic
`nyl chloride, polyamide elastomer and polyurethane;
`resin is preferable and the cross-linked ethylene-vinyl
`silicone rubber,
`latex rubber, etc. The thermoplastic
`acetete copolymer is more preferable. Further, the for-
`resin is preferable and the polyolefin is more preferable.
`ward and backward portions of the cylindrical portion
`Further, instead of providing the rigidity imparting
`3a of the expansible member 3 extending to the secured
`member to the inner tube, the outer tube may be pro-
`portions 7 and 8 to the inner and outer tubes 1 and 2
`vided with a rigidity imparting member. By disposing
`described aboveare tapered.
`the rigidity imparting member, collapse of the catheter
`Asthe size of the expansible member 3,the cylindri-
`main body at its bent portion can be prevented and,
`cal portion upon expanded has the outer diameter of
`further, the torque transmissionefficiency of the cathe-
`1.50 to 35.00 mm, preferably 2.00 to 30.00 mm and the
`ter main body can be improved. Asthe rigidity impart-
`length of 5.00 to 80.00 mm, preferably 10.00 to 75.00
`ing member, those describedin relation to the inner tube
`mm. The entire length of the expansible member 3 is
`1 can be suitably used. Further, it is preferable that the
`10.00 to 120.00 mm,preferably 15.00 to 100.00 mm.
`rigidity imparting member formed on the outer surface
`It is preferable that markers 14 made of X-ray imper-
`of the outer tube is embedded in the outer wall of the
`meable material (for example, gold, platinum or alloy
`outer tube to make the outer surface smooth. By making
`thereof) are provided on the portions near the base end
`the outer surface of the outer tube smooth, it can be
`of the side hole 12 and nearer to the tip side than the
`alleviated that clogs generate on the outer surface of the
`secured portion of the expansible member3 to the outer
`catheter and the inner wall of a blood vessel is damaged.
`tube 2 and located at both ends of the cylindrical por-
`Rigidity imparting members maybe disposed to both of
`tion 3a of the expansible member3. This is for enabling
`the inner and outer tubes 1 and 2.
`to confirm easily the position of the expansible member
`Theouter tube 2 has the outer diameter of 0.95 to 4.30
`3 under X-ray perspection. The form of the marker 14is
`mm, preferably 1.00 to. 4.00 mm and the inner diameter
`a ring made of metal described above and calked onto
`of 0.70 to 3.80 mm, preferably 0.80 to 3.00 mm. Further,
`the outer surface of the inner tube 1.
`the difference between the outer diameter of the inner
`Further, in the catheter equipped with the expansible
`tube 1 and the inner diameter of the outer tube2is 0.20
`memberaccordingto the present invention,it is prefera-
`to 3.30 mm,preferably 0.50 to 1.50 mm.
`ble for facilitating the insertion into a blood vessel and
`The expansible member3 is contractible or foldable
`further into a guide catheter described later to apply
`and it is contracted or folded on the outer circumfer-
`hydrophilic treatment to portions which can comeinto
`ence of the inner tube 1 in its non-expanded state. The
`contact with blood in operation, that is, the outer sur-
`expansible member 3 has a portion at least a part of
`faces of the outer tube 2 and expansible member3 so as
`whichis substantially cylindrical for enabling to expand
`to have lubricancy. As such hydrophilic treatment,
`a stricture portion in a blood vessel, and in the embodi-
`there can be mentioned a method of coating a hydro-
`ment shown in FIG.1,it has a substantially cylindrical
`philic polymer, for example, poly(2-hydroxyethylme-
`portion 3a: having the approximately uniform diameter.
`thacrylate), polyhydroxyethylacrylate, hydroxypropyl-
`The substantially cylindrical portion described above
`cellulose, methyl vinyl ether-maleic anhydride copoly-
`may not be completely cylindrical but may be polygo-
`mer, polyethylene glycol, polyacrylamide, polyvinyl
`nal. The rear end portion 8 of the expansible member 3
`pyrrolidone,etc.
`is secured in a liquid-tight manner to the tip portion of
`As shownin FIG.2, the branched hub 20 comprises
`the outer tube 2 by adhesion, fusion or the like. The tip
`an inner tube hub 22,an outer tube hub 23 anda sealing
`portion 7 is secured in a liquid-tight manner to the tip
`member 24. The inner tube hub 22 has an first opening
`portion of the inner tube 1 by the similar manner. As
`9 forming a guide wire port and a second opening 10
`shownin FIG. 5 showinga cross section of the catheter
`forming a vent port, and is secured to the base end
`equipped with the expansible member taken along line
`portion of the inner tube 1. Thefirst opening 9 is in
`B—B in FIG. 1, the expansible member 3 forms an
`communication with the first lumen 4 of the inner tube
`expanded space 15 between the inner surface of the
`1 and the second opening 10 is in communication with
`expansible member 3 and the outer surface of the inner
`the-second lumen 5 of the inner tube 1. The outer tube
`tube 1. The expanded space 15 is in communication at
`23 is secured to the base end portion of the outer tube 2
`its tip portion with the second lumen 5 throughthe side
`and has a third opening 11 forming an injection port.
`hole 12 of the inner tube 1 and overthe entire circum-
`Thethird opening 11 is in communication with the third
`ference at its rear end portion with the third lumen 6.
`lumen6. The sealing member24is disposed between the
`Thus, the third lumen 6 havinga relatively large vol-
`inner and outer tube hubs 22 and 23 to seal the rear end
`umeis in communication with the rear end of the expan-
`portion of the outer tube hub 23. These three members
`sible member 3 and the second lumen5 is in communi-
`of the inner and outer tube hubs 22 and 23 and sealing
`cation with the tip portion of the expansible member3.
`member 24 are secured to one another.
`Therefore, when expansionfluid is injected through the
`For the material for forming the branched hub, there
`third lumen 6 into the expansible member3, air within ,
`can be suitably used thermoplastic resin such as.poly-
`the third lumen 6 and further within the expansible
`carbonate, polyamide, polysulfone, polyarylate and
`member 3 is replaced by the fluid injected in accor-
`methacrylate-butylene-styrene. copolymer.
`Instead of
`dance with the inflow of the fluid. The air flows out to
`providing such a branched hub, for example, a tube
`the outside through the second Iumen 5 so that the air
`having a port member forming an openingat its rear end
`within the catheter main body can be easily removed.
`
`50
`
`60
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1011 - Page 9
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1011 - Page 9
`
`

`

`4,964,853
`
`7
`maybe attachedin a liquid-tight manner to each of the
`first, second and third lumens.
`Next, the operation of the catheter equipped with the
`expansible member according to the present invention
`will be described with reference to explanatory views
`shown in FIGS. 6 to 10 using the catheter equipped
`with the expansible member of the embodiment shown
`in FIGS.1 to 5.
`Before administering a dilatating cure of a stricture
`portion which has occurred in a blood vessel, air within
`the catheter equipped with the expansible memberis
`removed. For this purpose, the tip of the catheter ac-
`cording to the present invention is turned upwards,
`X-ray contrast liquid is injected through the third open-
`ing 11, the vasographic contrast liquid is made to flow
`from the base end side of the third lumen6 to the inside
`of the third lumen 6 and further to the inside of the
`expansible member 3, and the inside of the lumen 6 and
`the inside of the expansible member3 arefilled with the
`vasographic contrast liquid. The air within the expansi-
`ble member3 is made to flow throughtheside hole 12,
`second lumen 5 and second opening 10 to the outside in
`accordance with the inflow of the contrast liquid. The
`confirmation of the removal ofthe air from the inside of
`the catheter equipped with the expansible member can
`be made with the contrast liquid flowing out of the
`second opening 10. After confirming the removal of the
`air, the opening 10 is closed with a cap (not shown).
`Upon inserting the catheter 40 equipped with the
`expansible memberinto a blood vessel,at first, an inflow
`portion for the blood vessel is insured in the human
`body by meansof Seldinger methodorthe like, a guide
`wire for guide catheter (not shown)is then retained in
`the blood vessel, the guide catheter 30 is inserted into
`the blood vessel 35 along it, as shown in FIG.7, the
`guide catheter 30 is retained in the inlet 32 of the carro-
`nary artery including an aimed lesion part, and the
`guide wire for the guide catheter is withdrawn. As
`shown in FIG. 6, the catheter 40 equipped with the
`expansible member according to the present invention
`into which a guide wire 34 for catheter equipped with
`expansible member is inserted,
`is inserted through a
`Y-shaped connector 50 disposed at the rear end of the
`guide catheter 30. Insertion into the blood vessel
`is
`conducted in a state that the guide wire 34 for catheter
`equipped with expansible memberis protruded beyond
`the tip of the catheter 40 equipped with the expansible
`member by several centimeters. The catheter 40
`equipped with the expansible member advances in the
`guide catheter 30 and as shownin FIG.8, enters in the
`blood vessel 35 including the aimedlesion part by leav-
`ing the tip of the guide catheter 30. The guide wire 34
`for catheter equipped with expansible memberis ad-
`vanced to the aimed lesion part, passed through the
`stricture portion 36 and then retained. The catheter 40
`equipped with the expansible memberis advanced in the
`blood vessel 35 along the guide wire 34 for catheter
`equipped with expansible member. After the catheter 40
`equipped with the expansible member reaches a position
`nearthestricture portion 36, the expansible member3 is
`positioned in the stricture portion 36 under X-ray per-
`spection by using the X-ray impermeable markers 14
`disposed on the inner tube 1 as reference marks as
`shown in FIG. 9. Subsequently, vasographic contrast
`liquid is injected at a pressure from several atmospheres
`to ten and several atmospheres by means of an injector
`54 equipped with a pressure gauge connected to the
`third opening 11 forming the injection port ofthe cathe-
`
`8
`ter 40 equipped with the expansible member shownin
`FIG.6 to compress and expand the stricture portion 36
`as shown in FIG. 10. The contrast liquid is injected
`through a contrast liquid injection port 52 of the Y-
`shaped connector 50 of the guide catheter 30 shownin
`FIG.6 to confirm the state of blood stream on the pe-
`ripheral side by the X-ray perspection. When an im-
`provementof the blood flow on the peripheral side is
`recognized, the catheter 40 equipped with the expansi-
`ble memberand the guide wire 34 for catheter equipped
`with expansible member are withdrawn and then the
`guide catheter is withdrawn and bloodis stopped under
`pressure to complete the operation.
`INDUSTRIAL APPLICABILITY”
`
`20
`
`25
`
`30
`
`40
`
`45
`
`65
`
`Since a catheter equipped with an expansible member
`according to the present invention comprises an inner
`tube having a first lumen whose tip is open and a second
`lumen extending to the tip direction of the first lumen,
`an outer tube disposed coaxially with said inner tube
`and disposed at a position recessed by a predetermined
`distance from the tip of said inner tube and forming a
`third lumen between it and the outer surface of said
`inner tube, a contractible or foldable expansible member
`having a tip end portion and a base end portion, said
`base end portion beingfitted to said outer tube and said
`tip end portion beingfitted to said inner tube, said ex-
`pansible member communicating with said second
`lumen near said tip end portion and with said third
`lumen near said base end portion, a first opening com-
`municating with said first lumen and a second opening
`communicating with said second lumen disposed at the
`base end portionofsaid inner tube, and a third opening
`each disposed at the base end portionof said outer tube
`and communicating with said third lumen, especially,
`the third lumenis in communication with a portion near
`the base end portion of the expansible member and the
`second lumen is in communication with a portion near
`the tip end portion of the expansible member, when
`expansion fluid for the expansible memberis injected
`through the third lumen,air within the third lumen and
`further within the expansible memberis replaced by the .
`injected fluid in accordance with the inflow of the fluid.
`and the air can be made to flow through the second
`lumen and the second opening to the outside. There-
`fore, the air within the catheter can be easily and surely
`removed. Moreover, since the third lumen which is in
`communication with the portion near the base end por-
`tion of the expansible member and through which ex-
`pansion fluid for the expansible member is injected is
`formed between the inner tube and the outer tube, the
`third lumen has a relatively large volume so the expan-
`sion fluid can be easily injected even if it has a large
`flow resistance, for example, in the case of vasographic
`contrast liquid. Furthermore, since no metal pipe or the
`like is used for removing air from the inside of thé ex-
`pansible member, there is no worry that the catheter or
`expansible memberis damaged.
`Weclaim:
`1. A catheter equipped with an expansible member
`comprising an inner tube having a first lumen whosetip
`is open and a second lumen extendingto the tip direc-
`tion of the first lumen; an outer tube disposed coaxially
`with said inner tube and having a tip at a position re-
`cessed by a predetermined distance from thetip of said
`inner tube and forming a third lumen betweenit and the
`outer surface of said inner tube; a contractible or fold-
`able expansible member having a tip end portion and a
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1011 - Page 10
`
`Petitioner Edwards Lifesciences Corporation - Exhibit 1011 - Page 10
`
`

`

`4,964,853
`
`9
`base end portion, said base end portion being fitted to
`said outer tube and said tip end portion being fitted to
`said inner tube, said expansible member communicating
`with said second lumen near said tip end portion and
`with said third lumen near said base end portion;a first
`opening communicating with said first lumen and a
`second opening communicating with said second lumen
`