BSC USP 8,048,032
`Exhibit 1022
`
`Page 1 of 18
`
`United States Patent 119]
`Keith
`
`[54] BALLOON CATHETER WITH DISTAL
`GUIDE WIRE LUMEN
`[75] Inventor:
`Peter T. Keith, Edina, Minn.
`[73] Assignee: SciMed Life Systems, Inc., Maple
`Grove, Mi?n-
`
`_
`[21] Appl' No“ 574,265
`[22] Filed:
`Aug. 28, 1990
`
`5
`Eli {321%. 111....-...........:33111133133111?88278238838‘?
`604/232’
`[58] Field of Search ............................. .. 606/192, 194;
`'
`604/95_w3 282 204
`’
`’
`
`[56]
`
`lllllllllllllllllllllllllllllllllllllllllIllllllllllllllllllllllllllllllll
`US005156594A
`[11] Patent Number:
`5,156,594
`[45] Date of Patent:
`Oct. 20, 1992
`
`OTHER PUBLICATIONS
`“USCI LO Pro?le II Balloon Dilatation Catheters,” c. '
`R- Bind’ Inc-Y 1987' i
`_
`_
`“Untll someone does it, no one thinks 1t can be done,”
`C_ R_ Bard, Inc" 1933_
`Paul G. Yock, US. Patent Application Ser. No.
`852,197, ?led Apr. 15, 1986 made public Jun. 7, 1988.
`Monorail-Bonzel Coronary Dilatation System, Flyer (un
`dated),
`Monorail-Piccolino, Flyer, Oct. 1988.
`AC5 Rm Dilatation were" Hm 1988.
`Balloon Catheters For Percutaneous Insertion Into The
`Vascula’ Sys‘em' 315"‘ N°‘de“.s"6.m Ma" 2’ 1962'
`.
`“New Instruments for Cathetenzatton and Angiocardi
`ograpy” Bjb'rn Nordenstrom, JuL-Dec. 1965 Issue of
`Radiologl.
`Pn'mary Examiner—John D. Yasko
`Assism'llEmminer—Adam J- Cefmah
`Attorney, Agent, or Firm-Kinney & Lange
`
`References Cited
`U-S- PATENT DOCUMENTS
`2,687,131 8/1954 Raiche ............................... .. 128/349
`2,936,760 5/1960
`123/349
`3,225,762 12/1965
`128/214
`ABSTRACT
`[57]
`3,976,720 12/1980
`606/194
`An over-the-wire balloon dilatation catheter has a stain
`4,289,128 9/1981
`128/ 207,15
`4,468.224 8/1934 Enlmann CI 81
`less steel hypotube catheter shaft, an intermediate
`604/164
`sleeve section bonded to the shaft and a distal balloon
`- - ' ~ - " 604/96
`4,597,755 7/ 1986 Sam?“ 6‘ a1- ~ ' - ' - ~
`section connected to the sleeve section. The sleeve
`128/30“
`4'662'368 5/1987 Hussem 6‘ a1‘ "
`.
`.
`.
`.
`604/101
`4,705,507 11/1987 Boyles ............... ..
`55cm“ ‘5 .fc’rmed fromfelanvely ?ex‘ble pi?ymer mate‘
`128/344
`4 748,982 6/1988 Horzewski et a1. .
`"als and Includes 3" "met °°re tube whlch de?nes a
`4,762,129 8/1988 Bonzel .................... .. 128/344
`4:771,777 9/1988 Horzewski et al. .
`128/344 8 guide Wife lumen extending only through a distal Por
`4,798,598 1/1989 Bonello et a1. . . . . . .
`. . . .. 604/280
`tion of the Catheter (including its Sleeve and balloon
`4,320,349 4/1939 Saab ___________ __
`128/344
`sections) to facilitate fast balloon catheter exchanges. A
`4,824,435 4/1989 Geisy et a]. ..
`.. 604/49
`distal end of the hypotube shaft is crimped laterally and
`4,838,268 6/1989 Keith et al. ..
`128/344
`the core tube is nested and bonded within the crimp to
`4,846,174 7/1989 Willard 6‘ a1- -
`128/344
`provide a proximal outlet for the guide wire lumen. The
`4,877,031 10/1989 Conway et al. -
`128/344
`hypotube shaft providesan in?ation lumen for the bal
`z’ggg’gl?
`52333111351 "" "
`loon, with the in?ation lumen being continued as an
`606/194
`4'917‘08B 4/1990 Crmenden
`annular in?ation lumen through the sleeve section
`4:92l:478 5/1990 Solano et al. ....................... .. 604/53
`where 8" mm" Sleeve 18 bonded about the core tube and
`extends from the distal end of the hypotube shaft to the
`(List continued on next page.)
`balloon section. A kink-resistant coil structure extends
`distally from the distal end of the hypotube shaft to
`provide a gradual change in stiffness along the length of
`the catheter from the relatively stiff hypotube shaft to
`the relatively ?exible distal portion of the catheter.
`
`FOREIGN PATENT DOCUMENTS
`0344530 12/1989 European Pat. Off. .
`90-0365993 5/ 1990 European Pat. Off. .
`0368523 5/1990 European Pat. Off. .
`627828 10/1978 U.S.S.R. .
`12519111 8/1986 U.S.S.R. .
`
`56 Claims, 6 Drawing Sheets
`
`

`

`Page 2 of 18
`
`5,156,594
`Page 2
`
`US. PATENT DOCUMENTS
`128/637
`4,928,693 5/1990 Goodin et a1. .... ..
`128/772
`4,940,062 7/1990 Hampton et a1.
`.. 604/96
`4,943,278 7/ 1990 Eutenever et a1. 1
`606/194
`4,944,745 7/ 1990 Sogard et a1. .... ..
`606/ 194
`4,946,466 8/1990 Pinchuk et a1. .
`128/637
`4,953,553 9/ 1990 Tremulis ....... ..
`606/192
`4,988,356 l/1991 Crittenden et a1. .
`604/96
`4,994,032 2/1991 Sujiyama et a1.
`4,998,917 3/1991 Gaiser et a1‘ ........................ .. 604/96
`
`4,998,923 3/ 1991 Samson et a1. .................... .. 606/ 194
`5,032,113 7/1991
`5,034,001 7/ 1991
`5,035,705 7/ 1991
`5,042,985 8/1991
`5,047,045 9/1991
`5,050,606 9/ 1991
`5,057,120 10/1991
`..
`5,061,273 10/1991
`5,102,403 4/1992 Alt ..................................... .. 604/280
`
`

`

`U.S. Patent
`
`5
`
`V Oct. 20, 1992
`
`Sheet 1 of6
`
`5,156,594
`
`24
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`Page3of18
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`Page 3 of 18
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`US. Patent
`
`' Oct. 20, 1992
`
`Sheet 1 of6
`
`5,156,594
`
`

`

`U.S. Patent
`
`Oct. 20, 19925
`
`Sheet 2 of 6
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`5,156,594
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`\......'..................|
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`Page4of18
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`Page 4 of 18
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`U.S. Patent
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`Oct. 20, 1992
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`Sheet 3 of 6
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`5,156,594
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`Page5of18
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`Page 5 of 18
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`US. Patent
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`Oct. 20, 1992
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`Sheet 3 of 6
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`5,156,594
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`U.S. Patent
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`Oct. 20, 1992
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`Sheet 4 of 6
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`Page 7 of 18
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`US. Patent
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`Oct. 20, 1993
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`Sheet 5 of 6
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`5,156,594
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`US. Patent
`
`Oct. 20, 1992
`
`_ Sheet 6 of 6
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`5,156,594
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`

`

`Page 9 of 18
`
`1
`
`BALLOON CATHETER WITH DISTAL GUIDE ‘
`WIRE LUMEN
`
`25
`
`30
`
`35
`
`40
`
`45
`
`BACKGROUND OF THE INVENTION
`The present invention relates to the ?eld of angio
`plasty. In particular, the present invention relates to a
`dilatation balloon catheter of the “over-the-wire” type
`having a relatively short distal guide wire lumen ex
`tending through the balloon of the catheter.
`Angioplasty procedures have gained wide accep
`tance in recent years as ef?cient and effective methods
`for treating types of vascular disease. In particular,
`angioplasty is widely used for opening stenoses in the
`coronary arteries, although it is also used for the treat
`ment of stenoses in other parts of the vascular system.
`The most widely used form of angioplasty makes use
`of a dilatation catheter which has an in?atable balloon
`at its distal end. Typically, a hollow guide catheter is
`used in guiding the dilatation catheter through the vas
`cular system to a position near the stenoses (e.g., to the
`coronary artery ostia). Using ?uoroscopy, the physician
`guides the dilatation catheter the remaining distance
`through the vascular system until a balloon is positioned
`to cross the stenoses. The balloon is then in?ated by
`supplying ?uid under pressure through an in?ation
`lumen in the catheter to the balloon. The in?ation of the
`balloon causes stretching of the artery and pressing of
`the lesion into the artery wall, to reestablish acceptable
`blood ?ow through the artery.
`There has been a continuing effort to reduce the
`pro?le and shaft size of the dilatation catheter so that
`the catheter not only can reach but also can cross a very
`tight stenosis. A successful dilatation catheter must also
`be sufficiently ?exible to pass through tight curvatures,
`especially in the coronary arteries. A further require
`ment of a successful dilatation catheter is its “pushabil
`ity”. This involves the transmission of longitudinal
`forces along the catheter from its proximal end to its
`distal end so that a physician can push the catheter
`through the vascular system and the stenoses.
`Two commonly used types of dilatation catheters are
`referred to as “over-the-wire” catheters and “non-over
`the-wire” catheters. An over-the-wire catheter is one in
`which a separate guide wire lumen is provided in the
`catheter so that a guide wire can be used to establish the
`path through the stenoses. The dilatation catheter can
`then be advanced over the guide wire until the balloon
`on the catheter is positioned within the stenoses. One
`problem with the over-the-wire catheter is the require
`50
`ment of a larger pro?le and a generally larger outer
`diameter along the entire length of the catheter in order
`to allow for a separate guide wire lumen therethrough.
`A non-over-wire catheter acts as its own guide wire,
`and thus there is no need for a separate guide wire lu
`men. One advantage of a non-over-the-wire catheter is
`its potential for a reduced outer diameter along its main
`shaft since no discrete guide wire lumen is required.
`However, one disadvantage is the inability to maintain
`the position of the guide wire within the vascular sys
`tem when removing the catheter and exchanging it for
`a catheter having a smaller (or larger) balloon diameter.
`Thus, to accomplish an exchange with a non-over-the
`wire catheter, the path to the stenoses must be reestab
`lished when replacing the catheter with one having a
`different balloon diameter.
`In an effort to combine the advantages of an over-the
`wire catheter with a non-over-the-wire catheter, cathe
`
`5,156,594
`2
`ters have been developed which have guide wire lu
`mens which extend from a distal end of the catheter
`through the dilatation balloon and then exit the catheter
`at a point proximal of the dilatation balloon. The guide
`wire thus does not extend through the entire length of
`the catheter and no separate guide wire lumen is re
`quired along a substantially proximal section of the
`catheter. That proximal section can thus have a smaller
`outer diameter since it is only necessary to provide an
`in?ation lumen therethrough for catheter operation. A
`further advantage of this type of modi?ed over-the-wire
`catheter is that the frictional forces involved between
`the guide wire and the shortened guide wire lumen are
`reduced, thereby reducing resistance to catheter pusha
`bility and enhancing the “feel” and responsiveness of
`' the catheter to a physician.
`Perhaps the most signi?cant advantage of using a
`shortened guide wire lumen is in the ease of exchange of
`the catheter over the guide wire. In performing an angi
`oplasty procedure using such a catheter, the catheter is
`“back loaded" over the guide wire by inserting the
`proximal tip of the guide wire into a distal opening of
`the guide wire lumen in the catheter. The catheter is
`then advanced by “feeding” the catheter distally over
`the guide wire while holding the guide wire stationary.
`The proximal end of the guide wire will then emerge
`out of the proximal opening of the guide wire lumen
`(which is substantially space distally from the proximal
`end of the catheter itself) and is accessible again for
`gripping by the physician. The catheter can be pre
`loaded onto the guide wire in this manner before the
`guide wire is inserted into the guide catheter or after. In
`either case, the guide wire is steered and passed through
`the guide catheter, coronary vessels and across a lesion.
`The exposed portion of the guide wire is then grasped
`while the catheter is advanced distally along the guide
`wire across the lesion. Using this procedure, little axial
`movement of the guide wire occurs during catheter
`loading and positioning for angioplasty.
`If the dilatation balloon is found to be inadequate (too
`small or too large), the catheter can be similarly with
`drawn without removing the guide wire from across the
`lesion. The guide wire is grasped while the catheter is
`withdrawn, and when the proximal opening of the
`guide wire lumen is reached, the grasping hand must be
`moved incrementally away from the proximal opening
`as the catheter is incrementally withdrawn, until the
`catheter is fully removed from the guide catheter and
`the guide wire is thus again exposed and accessible
`adjacent to the proximal end of the guide catheter.
`This shortened guide wire lumen type of dilatation
`catheter design thus offers the advantages associated
`with the rapid exchangeability of catheters. The design
`also presents the potential to provide a smaller catheter
`shaft, since the guide wire is not contained within the
`proximal portion of the catheter shaft. The smaller cath
`eter shaft thus allows for better contrast media injection
`and, as a result, better visualization. In addition, because
`of the rapid exchangeability features, standard non
`extendable guide wires of approximately 175 centime
`ters in length may be used. Further, because the guide
`wire is contained in only a distal shorter guide wire
`lumen of the catheter, free wire movement is enhanced
`when compared to a standard over-the-wire catheter
`where the guide wire extends through a guide wire
`lumen extending along the entire length of the catheter.
`
`55
`
`65
`
`

`

`Page 10 of 18
`
`3
`While several structures for such shortened guide
`wire lumen dilatation catheter have been proposed
`these structures suffer from several disadvantages. Such
`catheters have been one piece polyethylene catheters
`having dual lumen con?gurations adjacent their distal
`regions. Typically, such catheters have larger than nec
`essary shaft sizes and are stiffer in their distal regions
`than would be desired, including those portions bearing
`the dilatation balloon. A further disadvantage is that the
`proximal shaft portion of such catheters is relatively
`?exible, and has low column strength shaft, so that it
`tends to “bunch” and buckle when advanced across a
`lesion. To counteract this deficiency in such designs,
`additional stiffener elements have been provided in the
`shaft, which necessarily require a larger catheter shaft
`to accommodate the stiffener element structure. The
`known dilatation balloon catheter designs which in
`clude shortened guide wire lumens extending through
`the distal portion of the catheter suffer from the disad
`vantages mentioned above and do not take advantage of
`the unique opportunities presented by the possibilities of
`such designs in construction and application.
`
`15
`
`25
`
`35
`
`5,156,594
`4
`of the proximal tube is smaller than the outer diameter
`of the distal tube, thus providing a catheter structure
`which is highly trackable and has a generally small shaft
`outer diameter, yet is very pushable and responsive to a
`doctor controlling movement of the catheter from its
`proximal end. Preferably, the means for exposing in
`cludes a longitudinal crimp adjacent the distal end of l
`the distal stainless steel tube. The crimp extends later
`ally inwardly from one side of the distal tube, and has a
`proximal transition region and distal bonding region.
`The proximal end of the inner core tube is nested within
`the distal bonding region of the crimp and bonded
`thereto. The outer sleeve extends over at least a distal
`portion of the bonding region and is sealably affixed
`thereabout.
`The means for preventing closure of a present inven
`tion may take a number of different forms. In a pre
`ferred embodiment, the means for preventing closure
`comprises a coil member affixed to the sleeve section
`adjacent the distal end of the metallic tube. As such, the
`coil member may be affixed about the outer sleeve to
`extend distally from the metallic tube or about the inner
`core tube to extend distally from the metallic tube. Such
`a coils member further may have its coil spaced uni
`formly apart or spaced increasingly apart as it extends
`distally from the metallic tube. Preferably, the coil
`member is formed from a spirally shaped ribbon. A
`compression sheath is provided to envelope the coil
`member and maintain the coil member in secure engage
`ment to the sleeve section. In an alternative embodi
`ment, the means for preventing closure comprises a
`tubular member affixed to the sleeve section adjacent
`the distal end of the metallic tube, with the tubular
`member being formed from a polyimide material.
`Such closure preventing means thus provide a bend
`ing relief design between the relatively stiff metallic
`tube and more ?exible distal region of the balloon dila
`tation catheter, to prevent kinking during catheter prep
`aration work and handling (prior to insertion of the
`dilatation catheter into the guide catheter and patient).
`Such kinking or “crimping” of the catheter can result in
`a binding on the guide wire as it extends through the
`guide wire lumen or a reduction in size of the annular
`in?ation lumen between the metallic tube and balloon
`or a compromise in strength of the catheter tubings, all
`of which will compromise the utility and responsiveness
`of the dilatation catheter. In addition, the closure pre
`venting means reduces the possibility of a failure or
`separation of the bonds adjacent the distal end of the
`metallic tube which may be caused by excess strain
`placed on such bonds during catheter preparation or
`handling.
`BRIEF DESCRIPTION OF THE DRAWINGS
`FIG. 1 is a side elevational view of a balloon dilata
`tion catheter of the present invention having a distal
`guide wire lumen therethrough and showing a guide
`wire.
`FIG. 2 is a sectional side elevational view of the
`balloon dilatation catheter of FIG. 1.
`FIG. 3 is an enlarged sectional view as taken along
`lines 3—3 in FIG. 2.
`FIG. 4 is a sectional side elevational view of a portion
`of the catheter of the present invention, illustrating an
`alternative structure for a reinforcing coil member
`thereon.
`FIG. 5 is a sectional side elevational view of a portion
`of the catheter of the present invention, illustrating an
`
`40
`
`SUMMARY OF THE INVENTION
`The present invention is an over-the~wire dilatation
`balloon catheter which has a guide wire lumen extend
`ing through only a distal portion of the catheter. The
`guide wire lumen extends from a distal end of the cathe
`ter proximally through a balloon of the catheter and
`exits the catheter at a point proximal of the balloon, but
`substantially distally from a proximal end of the cathe
`ter itself.
`The present invention for a balloon dilatation cathe
`ter includes a thin-walled, high strength metallic tube
`having a longitudinal in?ation lumen extending there
`through from its proximal end to its distal end. An inter
`mediate sleeve section extends distally from the metallic
`tube. The sleeve section is more flexible than the metal
`lic tube, and includes a proximal segment of inner core
`tube which has a longitudinal guide wire lumen extend
`ing therethrough and an outer sleeve which extends
`over the proximal segment of the core tube to define a
`longitudinally extending annular in?ation lumen there
`between that is in ?uid communication with the in?a
`tion lumen of the metallic tube. The guide wire lumen
`has an outlet at a proximal end of the proximal segment
`of the core tube, and the core tube has a distal segment
`which extends distally beyond the distal end of the
`outer sleeve. Means are provided for exposing the guide
`wire lumen outlet to the exterior of the catheter adja
`cent and proximal to the distal end of the metallic tube,
`without compromising the integrity of the in?ation
`lumens extending through the catheter. An in?atable
`balloon extends over the distal segment of the core tube
`and has its proximal end connected to the distal end of
`55
`the outer sleeve. A distal end of the balloon is con
`nected to the core tube so that an interior of the balloon
`is in ?uid communication with the annular in?ation
`lumen in the sleeve section. Means are provided for
`preventing signi?cant closure of the guide wire lumen
`and annular in?ation lumen in the sleeve section adja
`cent the distal end of the metallic tube when the more
`?exible sleeve section is bent laterally relative to the
`metallic tube.
`In a preferred embodiment of the present invention,
`the metallic tube is formed from a proximal relatively
`long stainless steel tube and a distal relatively short
`stainless steel tube bonded thereto. The outer diameter
`
`45
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`Page 11 of 18
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`5
`6
`mately 135 cm and a typical guide wire length of ap
`alternative structure for a reinforcing coil member
`thereon.
`proximately 175 cm. As illustrated in FIG. 1, the guide
`FIG. 6 is an enlarged sectional view as taken along
`wire 50 extends longitudinally along the exterior of the
`lines 6——6 in FIG. 5.
`main shaft section 22 of the catheter 20. Adjacent the
`FIG. 7 is a sectional view of a portion of an alterna
`distal end 30 of the main shaft section 22, the guide wire
`tive embodiment of the catheter of the present inven
`50 enters the structure of the catheter 20 and extends
`tion.
`distally therethrough until it exits the catheter structure
`FIG. 8 is a sectional view of a portion of an alterna
`adjacent the distal waist 40 of the distal balloon segment
`tive embodiment of the catheter of the present inven
`26. As seen FIG. 2, a separate guide wire lumen 52 is
`tion.
`provided in the catheter 20 through the intermediate
`FIG. 9 is a sectional view of a portion of an alterna
`sleeve section 24 and distal balloon section 26 thereof.
`tive embodiment of the catheter of the present inven
`The guide wire 50 thus is only entrained within the
`tion.
`catheter 20 within this guide wire lumen 52, which is
`FIG. 10 is a sectional view of a portion of an alterna
`much shorter than the total length of the catheter 20
`tive embodiment of the catheter of the present inven
`(e.g., the guide wire lumen 52 is approximately 30 cm
`tion.
`long). The guide wire 50 has a proximal end 53 and a
`FIG. 11 is a sectional view of a portion of an alterna
`distal end 54 and is of a typical structure for guiding
`tive embodiment of the catheter of the present inven
`angioplasty catheters. At its distal end 54, the guide
`tion.
`wire 50 preferably has a coiled and rounded tip struc
`FIG. 12 is a sectional view of a portion of an alterna
`ture which is bendable for steerability of the guide wire.
`tive embodiment of the catheter of the present inven
`Referring now to FIG. 2, which shows the catheter
`tion.
`20 in greater detail, it is seen that the proximal end 28 of
`FIG. 13 is a sectional view of a portion of an alterna
`the main shaft section 22 further has a strain relief tube
`tive embodiment of the catheter of the present inven
`60 disposed between the luer manifold 42 and shaft
`tion.
`section 22. The strain relief tube 60 is larger than the
`Although the above-identified drawing ?gures set
`main shaft section 22, and thus provides a step-wise
`forth various embodiments of the invention, other em
`strain relief function between the in?exible luer mani
`bodiments of the invention are also contemplated, as
`fold 42 and the more ?exible main shaft section 22. The
`noted in the discussion. In all cases, this disclosure pres
`main shaft section 22, tubular member 60 and luer mani
`ents illustrated embodiments of the present invention by
`fold 42 are secured together'respectively by suitable
`way of representation and not limitation. It should be
`adhesive means, such as epoxy or cyanoacrylate.
`understood that numerous other modi?cations and em
`bodiments can be devised by those skilled in the art
`which will fall within the scope and spirit of the princi
`ples of this invention.
`DETAILED DESCRIPTION OF THE
`PREFERRED EMBODIMENTS
`Overall Catheter Structure
`A balloon dilatation catheter 20 of the present inven
`tion is illustrated generally in FIG. 1. The catheter 20
`has a proximal main shaft section 22, an intermediate
`sleeve section 24 and a distal balloon section 26. The
`main shaft section 22 has a proximal end 28 and a distal
`end 30. Likewise, the intermediate sleeve section 24 has
`a proximal end 32 and a distal end 34. The distal balloon
`section 26 has a proximal waist 36, an intermediate
`expandable segment 38 and a distal waist 40.
`As illustrated in FIG. 1, the distal end 30 of the main
`shaft section 22 is connected to the proximal end 32 of 50
`the sleeve section 24, and the distal end 34 of the sleeve
`section 24 is connected to the proximal waist 36 of the
`balloon section 26. In use, the catheter 20 is coupled to
`an in?ation device (not shown) by a luer manifold 42
`connected to the proximal end 28 of the main shaft
`section 22. The in?ation device thus provides or re
`moves in?ation solution from the catheter 20 to select
`ably in?ate or de?ate the intermediate expandable seg
`ment 38 of the distal balloon section 26 (in FIG. expand
`able segment 38 is shown in its in?ated con?guration).
`The catheter 20 of the present invention is designed
`for use in combination with a catheter guide element
`such as a guide wire 50. In use in a coronary application,
`both the guide wire 50 and the catheter 20 are fed
`through and guided to an arterial lesion by means of a
`tubular guide catheter (not shown). Both the catheter
`20 and guide wire 50 are therefore longer than the guide
`catheter, with a typical catheter length ‘of approxi
`
`Main Shaft Section
`The main shaft section 22 is preferably formed as a
`thin-walled, high strength stainless steel tube structure,
`which is referred to as hypodermic tubing or hypotube.
`As a tubular structure the main shaft section 22 thus has
`a longitudinally extending in?ation lumen 62 extending
`therethrough from its proximal end 28 to its distal end
`30, which provides a means for the movement and pres
`surization of in?ation ?uid through the catheter 20 to
`and from the distal balloon section 26.
`In a preferred embodiment, the main shaft section 22
`is formed from two stainless steel tube sections, a proxi
`mal relatively long shaft section 64 and a distal rela
`tively short shaft section 66. A distal end of the proxi
`mal shaft section 64 and a proximal end of the distal
`shaft section 66 are sealably af?xed together by suitable
`means, such as by a solder joint. The proximal end of
`the distal shaft section 66 ?ts coaxially over the distal
`end of the proximal shaft section 64, as seen in FIG. 2,
`thereby allowing the proximal shaft section 64 to as
`sume a smaller outer diameter than the distal shaft sec
`tion 66. The main shaft section 22 is provided with a
`lubricous coating (such as polytetra?ouroethylene) to
`lessen frictional resistance (at least to the extent that the
`proximal shaft section 64 is so coated). The use of a
`thin-walled (e.g., 0.003 inch wall thickness), metallic
`tube structure for the main shaft section 22 thus pro
`vides a stiff enough shaft for pushability yet allows for
`a relatively small diameter shaft, thereby enhancing
`catheter visualization via ?uoroscopy and catheter ver
`satility. The inherent high strength nature of such a
`structure also allows it to withstand the ?uid pressures
`necessary for proper catheter operation, which in a
`plastic shaft structure would require thicker walls. The
`high column strength and thickness of a hypotube shaft
`
`45
`
`55
`
`65
`
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`Page 12 of 18
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`5,156,594
`8
`7
`also gives improved responsiveness to the catheter.
`20 are not compromised to the exterior of catheter 20,
`but are in ?uid communication therethrough.
`Thus, the balloon and distal regions of the catheter
`The intermediate sleeve structure de?ned above is
`move de?nitively (in a 1:] relationship) with motions
`imparted at the catheter’s proximal end by a physician.
`the basic sleeve structure for all embodiments of the
`present invention contemplated and disclosed herein-
`This feature allows the physician to actually “sense” the
`pathway as the catheter is tracked, which gives valu
`namely, an inner core tube bonded to a distal portion of g
`the main catheter shaft, with an outer sleeve forming an
`able information in the passage of the catheter to and
`through the lesion.
`annular continuation of the in?ation lumen through the
`In the distal shaft section 66 of the main shaft section
`main shaft between the core tube and outer sleeve. As
`discussed below and illustrated herein, various con?gu
`22, a longitudinal crimp 68 is provided which extends
`rations of the connections and components relative to
`laterally inwardly from one side of the distal section 66.
`the formation of the distal guide wire lumen, including
`The distal shaft section 66 has three sections, a proximal
`the coupling of the main shaft to the intermediate sleeve
`tubular region 70, a transition region 72, and a distal
`bonding region 74. The crimp 68 extends from its proxi
`section, are contemplated.
`mal origin in the transition region 72 to itsiigreatest
`lateral depth in the bonding region 74. The crimp 68, as
`further illustrated in FIG. 3, does not seal off or close
`the in?ation lumen 62, but does transform the in?ation
`lumen from a circular lumen 62 to a crescent shape
`through the bonding region 74, as seen at 63 in FIG. 3.
`
`20
`
`Catheter Distal Balloon Section
`The distal balloon section 26 is connected to the com
`ponents of the intermediate sleeve section 24. The prox
`imal waist 36 of the balloon section 26 is connected to
`the distal end 102 of the outer sleeve 82 by suitable
`means, such as by epoxy or cyanoacrylate. The distal
`waist 40 of the balloon section 26 is bonded to the core
`tube 80 adjacent its distal end 90 by suitable means, such
`as by epoxy or cyanoacrylate. An interior 106 of the
`balloon section 26 is thus sealed and in ?uid communi
`cation with the annular in?ation lumen 104 within the
`sleeve section 24. In a preferred embodiment, the bal
`loon section 26 is formed from a compliant balloon
`material (e.g., polyolefm), although a balloon formed
`from thin-walled non-compliant material
`(e. g.,
`PET-polyethylene terephthalate) is also contem
`plated.
`
`Kink-resistant Structure
`The metallic main shaft section 22 is relatively stiff
`compared to the polyethylene intermediate sleeve sec
`tion 24. This creates a rather abrupt change in the ?exi
`bility of the materials for the catheter 20 adjacent the
`distal end 30 of the main shaft section 22 (at the bonding
`region 74). The use of a hypotube for the main shaft
`section 22 in the catheter 20 creates a catheter which is
`considerably stiffer than most previous over-the-wire
`angioplasty balloon catheter designs. Such stiffness is
`not a concern as long as the metallic main shaft section
`22 remains in the relatively straight guide catheter
`within the patient, and indeed such stiffness provides
`distinct benefits in use of the catheter 20, as described
`above. In the distal portions of the catheter 20 (interme
`diate sleeve section 24 and distal balloon section 26), the
`catheter 20 must be very trackable and ?exible in order
`to negotiate the tortuous coronary anatomy to and
`across the lesion. The relatively sharp transition in stiff
`ness as the catheter structure changes from the metallic
`main shaft section 22 to the much more ?exible polymer
`intermediate sleeve section 24 creates two concerns.
`First, during handling of the catheter prior to usage,
`there is a potential to kink the catheter structure at that
`?exibility transition point. Secondly, when the catheter
`is in vivo, the distal end 30 of the main shaft section 22
`could potentially “dig in” to the guide catheter and
`create excessive friction due to the lack of bending
`support from the more ?exible intermediate sleeve sec
`tion 24.
`To address these concerns, a kink-resistant structure
`110 is provided to prevent kinking and possible damage
`to the intermediate sleeve section 24 during catheter
`preparation, handling and use. In its simplest form, this
`kink-resistant structure 110 provides a member of inter
`
`25
`
`30
`
`35
`
`Catheter Intermediate Sleeve Section
`The intermediate sleeve section 24 extends distally
`from the main shaft section 22, and is bonded thereto
`adjacent the bonding region 74 of the distal shaft section
`66. The intermediate sleeve section 24 has two primary
`longitudinal components, an inner core tube 80 and an
`outer sleeve or tube 82. The inner core tube 80 has a
`proximal segment 84 within the sleeve section 24 and a
`distal segment 86 within the distal balloon section 26.
`The inner core tube 80 and outer sleeve 82 are both
`preferably formed from thin-walled high density poly‘
`ethylene.
`,