`United States Patent
`[11] Patent Number:
`5,902,290
`
`Peacock, 111 ct al.
`[45] Date of Patent:
`*May 11, 1999
`
`
`U5005902290A
`
`
`604/96
` 5,195,971 3/ 993 Sirhan ..
`
`5,201,723
`4/ 993 Quinn
`.. 604/264
`5,246,421
`9/ 993 Saab.
`5,257,974
`11/ 993 Cox.
`.. 604/96
`5,279,562
`1/ 994 Sirhau etal.
`
`5,279,596
`1/ 994 Casteneda el al. .
`5,318,535
`6/ 994 Miraki.
`
`5,328,472
`7/ 994 Steinke et a1.
`5,344,402
`9/ 994 Crocker
`5,380,304
`1/ 995 Parker .....
`5,383,890
`1/ 995 Mirakiet a1.
`5,542,925
`8/ 996 Orth ............
`.
`5,554,114
`9/ 996 Vw’allace et al.
`5,573,509
`11/ 996 Thornton .........
`5,591,129
`1/ 997 Shoup et al.
`5,630,806
`5/ 997 Ingaki et a1.
`FOREIGN PATENT DOCUMENTS
`
`604/102
`. 604/96
`604/282
`,. 606/194
`.. 604/102
`604/53
`
`.. 604/102
`604/96
`.. 604/282
`
`
`
`..
`
`
`
`[54]
`
`[75]
`
`CATHETER PROVIDING INTRALUMINAL
`ACCESS
`
`Inventors: James C. Peacock, III, Corona Del
`Mar; Richard J. Saunders, Redwood
`City, both of Calif.
`
`[73]
`
`Assignee: Advanced Cardiovascular Systems,
`Inc., Santa Clara, Calif.
`
`Notice:
`
`This patent issued on a continued pros—
`ecution application filed under 37 CFR
`1.53(d), and is subject to the twenty year
`patent
`term provisions of 35 U.S.C.
`154(a)(2).
`
`[21]
`
`[22]
`
`Appl, No.2 08/805,896
`
`Filed:
`
`Feb. 24, 1997
`
`Related US. Application Data
`
`Continuation of application No. 08/589,910, Jan. 23, 1996,
`abandoned, which is a continuation of application No.
`08/212,225, Mar. 14, 1994, abandoned.
`
`Int. Cl.° .................................................... A61M 25/00
`
`US. Cl. ....................... 604/282; 604/264
`
`Field of Search
`..... 604/96, 102, 264,
`604/280, 282
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`604/282 X
`
`................... 604/282
`
`3,938,529
`4,581,017
`4,737,153
`4,739,768
`4,932,413
`4,944,740
`4,947,864
`4,976,689
`5,120,323
`5,163,921
`
`2/1976 Gibbons
`4/1986 Sahota .
`4/1988 ShimamuIa et al.
`4/1988 Engelson .
`.
`6/1990 Shockey et a1.
`7/1990 Buchbinder et a1.
`8/1990 Shockey et a]. .
`12/1990 Buchbinder ct al.
`6/1992 Shockcy ct al. .
`11/1992 Feiring,
`
`.
`
`.
`
`0 439 032 A-1
`W'O 93/01856
`W'O 93/13826
`W'O 93/21985
`
`.
`
`12/ 990 European Pat. OH.
`2/ 993 WIPO .
`7/ 993 WIPO .
`11/" 993 WIPO .
`OTHER PUBLICATIONS
`
`Michael B. Selig, M.D., “Lesion Protection During Fixed—
`Wire Balloon Angioplasty: Use of ‘Buddy Wire’ Technique
`and Access Catheters," Catheterization and Cardiovascular
`Diagnosis 252331—225 (1992).
`Primary Examiner—Corrine M. McDermott
`Attorney, Agent, or Firm41eller, Ehrman, White &
`McAuliffe
`
`[57]
`
`ABSTRACT
`
`An intraluminal catheter which provides access to distal
`locations within a patient’s body lumen and which is pro—
`vided with a flexible distal section having an inner lining, an
`outer jacket or coating and a helical coil between the lining
`andjacket. The distal section of the catheter is quite flexible
`yet it has sufficient transverse or radial rigidity to prevent
`significant distortion of the transverse cross—sectional shape
`of the catheter.
`
`16 Claims, 3 Drawing Sheets
`
`40
` 42
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`Page 1
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`Medtronic Exhibit 1417
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`Page 1
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`Medtronic Exhibit 1417
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`US. Patent
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`May 11, 1999
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`Page 2
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`Medtronic Exhibit 1417
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`Page 2
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`Medtronic Exhibit 1417
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`US. Patent
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`May 11, 1999
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`Sheet 2 0f 3
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`5,902,290
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`Medtronic Exhibit 1417
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`Page 3
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`Medtronic Exhibit 1417
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`US. Patent
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`May 11, 1999
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`Sheet 3 0f 3
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`5,902,290
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`Medtronic Exhibit 1417
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`Page 4
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`Medtronic Exhibit 1417
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`5,902,290
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`1
`CATHETER PROVIDING INTRALUMINAL
`ACCESS
`
`This is a continuation of application Ser. No. 08/589,910,
`which was filed on Jan. 23, 1996, now abandoned which is
`a continuation of 08/212,225, filed Mar. 14, 1994 now
`abandoned.
`
`FIEID OF‘ THE INVENTION
`
`This invention generally relates to intraluminal access
`catheters which are adapted to facilitate the advancement
`and withdrawal of intraluminal devices such as balloon
`dilatation catheters, guidewires and the like used in percu-
`taneous transluminal coronary angioplasty (PTCA) proce-
`dures.
`
`BACKGROUND OF THE INVENTION
`
`In typical PTCA procedures, a guiding catheter having a
`preshaped distal
`tip is percutaneously introduced by a
`Seldinger technique into the cardiovascular system of a
`patient and advanced within the system until the preshaped
`distal tip of the guiding catheter is disposed within the
`ascending aorta adjacent the ostium of the desired coronary
`artery. The guiding catheter is relatively stiff because it has
`to be twisted or torqued from its proximal end, which
`extends outside the patient,
`to turn the distal tip of the
`guiding catheter so that it can be guided into the desired
`coronary ostium. A balloon dilatation catheter is introduced
`into and advanced through the guiding catheter and out the
`distal tip thereof into the patient’s coronary artery until the
`balloon on the distal extremity of the dilatation catheter is
`properly positioned across the lesion to be dilated. Once
`properly positioned, the balloon is inflated one or more times
`to a predetermined size with radiopaque liquid at relatively
`high pressures (e.g., generally 4—12 atmospheres) to dilate
`the stenotic region of the diseased artery. When the dilata—
`tions have been completed, the balloon is finally deflated so
`that the dilatation catheter can be removed from the dilated
`stenosis to allow the resumption of normal blood flow
`through the dilated artery.
`There are several types of balloon dilatation catheters
`which are now widely available, including over-the-wire
`catheters,
`lixed—wire catheters, rapid exchange type cath—
`eters (which are a type of over-the-wire catheter) and
`perfusion type catheters (which may be either over—the—wire
`or fixed-wire catheters).
`It is not uncommon during an angioplasty procedure to
`have to exchange the dilatation catheter once the dilatation
`catheter has been advanced within the patient’s coronary
`artery. For example, if the physician determines that the
`inflated balloon size of the catheter is inappropriate for the
`stenosis to be dilated, the dilatation catheter will be with—
`drawn and an appropriately sized dilatation catheter will be
`advanced into the coronary artery to dilate the stenosis.
`If the dilatation catheter employed is an over-the-wire
`type dilatation catheter, the catheter may be withdrawn from
`the patient with the guidewire remaining in place across the
`stenosis to be dilated so that access to this stenotic region is
`not lost. It should be noted that it may take the physician
`from about 15 minutes to up to two hours or more to first
`advance the guidewire into the patient’s coronary artery and
`across the stenosis to be dilated and then advance the distal
`portion of the dilatation catheter having the balloon across
`the stenotic region.
`However, when a fixed-wire dilatation catheter is with-
`drawn from the patient’s coronary artery,
`in order
`to
`
`2
`exchange the catheter for another sized fixed-wire catheter
`or another type catheter, access to the stenotic region is lost.
`It may take the physician an hour or more to advance a
`replacement fixed—wire catheter or a guidewire over which
`an over-the-wire dilatation catheter can be advanced through
`the patient’s tortuous coronary anatomy in order to reach the
`arterial stenotic region in which the first lixed—wire dilatation
`catheter was located.
`
`Exchange type catheters are described in US. Pat. No.
`4,944,740 and US. Pat. No. 4,976,689 which are designed
`to facilitate the advancement and withdrawal of fixed-wire
`devices within a patient’s coronary arteries without loss of
`access to the stenotic region. However,
`the commercial
`
`
`embodiments of these patents has been found to be relatively
`
`
`ine ective when they are advanced through highly tortuous
`coronary arteries and when using guiding catheters with
`small radii of curvatures, i.e. tight curvatures, such as found
`in guiding catheters having Amplatz configurations. Com-
`mercially available exchange type catheters have a tendency
`to collapse or kink when advanced through tight curvatures,
`thereby preventing the passage of the fixed—wire or other
`type of intravascular catheter through the inner lumen of the
`exchange catheter. In some instances the change in trans-
`verse cross—sectional shape of the inner lumen of commer-
`cially available exchange catheters from circular to oval
`shaped is sufficient to prevent or retard the passage of a
`dilatation catheter or guidewire through the exchange cath-
`eter.
`What has been needed and heretofore unavailable is an
`exchange type catheter having a highly flexible distal end
`which has suflicient radial rigidity to maintain the cross—
`sectional shape of the inner lumen when the distal end is in
`a configuration with a small radius of curvature. The present
`invention satisfies that and other needs.
`
`SUMMARY OF THE INVENTION
`
`The present invention is directed to an improved intralu—
`minal access catheter which is particularly suitable for
`facilitating the advancement and the Withdrawal of intra—
`vascular devices such as fixed-wire and other types of
`dilatation catheters, guidewires and the like through a
`patient’s coronary arteries.
`The access catheter of the invention has an elongated
`proximal portion, a relatively short distal portion and an
`inner lumen extending therethrough which is adapted to
`facilitate the passage theretlirough of guidewires, fixed-wire
`and over-the-wire dilatation catheter and other intravascular
`devices. The proximal portion of the catheter is sufficiently
`stiff to facilitate advancing the catheter through a guiding
`catheter and a patient’s coronary artery. The distal portion is
`longitudinally flexible enough so as to be readily advanced
`through guiding catheters having distal ends with tight
`curvatures and tortuous coronary anatomy and it has suffi—
`cient radial rigidity so that the transverse cross-sectional
`shape of the inner lumen which extends through the distal
`portion is maintained even when the distal portion of the
`catheter is put into a configuration with one or more tight
`curvatures.
`
`The flexible distal portion of the access catheter, which is
`dimensioned to be advanced through the a human patient’s
`coronary artery, generally has a tubular shape and comprises
`an inner
`lining delining the inner lumen extending
`therethrough, which preferably has an inner lubricous
`surface, an outer plastic jacket and a supporting coil dis-
`posed between the inner tubular lining and an outer jacket.
`The supporting coil is a self supporting tubular structure and
`
`10
`
`15
`
`40
`
`LIIO
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`LIILA
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`60
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`Page 5
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`5,902,290
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`10
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`15
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`3
`may be a singular, helically wound coil or a two or more
`strands which have been braided. A helically wound coil is
`preferred in order to provide a greater degree of flexibility to
`the distal portion of the catheter shaft. The plastic jacket and
`the inner tubular lining may be formed of separate materials
`and secured together with the coil therebetween by means of
`a suitable adhesive or they may be formed of separate tubes
`of the same material and formed into a unitary construction
`by heat bonding the outer jacket and the inner tubular lining
`together with the helical coil disposed between the tubular
`members. Other means of forming the exchange catheter of
`the invention are contemplated, such as coextruding the
`inner tubular lining and the outer jacket from the same or
`similar polymeric materials about the coil and heat forming
`the extruded tubular member to bond the components
`together into the catheter shaft alter the extruding proce—
`dures.
`The polymer material from which the outer jacket on the
`distal portion of the exchange catheter is made is a thermo-
`plastic polymer which is preferably selected from the group
`consisting of polyurethane, polyethylene, polyvinyl
`chloride, polypropylene, polyamide and the like. Preferably,
`the cured polymer jacket on the distal end should have
`durometer hardness (Shore) of about 90A to about 55D. The
`diameter 0 the inner lumen extending through the exchange
`catheter should range from about 0.008 to about 0.06 inch in
`order to accommodate various sizes of dilatation catheters.
`
`
`Several di erent sized access catheters can be offered to
`handle the entire size range of available dilatation catheters,
`guidewires and other intravascular devices.
`In one presently preferred embodiment the access catheter
`is provided with one or more perfusion ports in the wall of
`the distal portion of the access catheter so that oxygenated
`blood can pass into the interior lumen of the exchange
`catheter at a proximal location on the distal portion of the
`catheter and then out of the distal portion of the catheter at
`various locations along its length which may be both proxi-
`mal and distal to the stenotic region of the patient’s artery
`which is to be dilated.
`the access
`In another presently preferred embodiment
`catheter is provided with a distal guidewire port located in
`the distal end of the catheter and a proximal guidewire port
`spaced a short distance, e.g. at
`least about 5 cm, and
`preferably at least about 10 cm, from the distal port and a
`substantial distance, e.g. about 80 to about 120 cm, from the
`proximal end of the exchange catheter. Both guidewire ports
`are in communication with the inner lumen which extends
`through the distal portion of the catheter.
`In use, the access catheter of the invention is advanced
`over a guidewire or fixed—wire dilatation catheter which has
`been previously positioned within the patient’s coronary
`artery until the distal end of the access catheter extends to a
`location adjacent to or within the stenosed arterial region. In
`the case of the fixed Wire catheters, the adapter must be
`removed in order to advance the access catheter over the _
`in-place fixed wire catheter. The adapter may be a removable
`adapter or it may be severed from the proximal end of the
`catheter. The guidewire or fixed-wire dilatation catheter may
`then be withdrawn through the inner lumen of the access
`catheter while maintaining the position of the distal end of
`the access catheter at or near the location of the distal end of
`the guidewire or fixed—wire catheter prior to the withdrawal
`thereof. A replacement
`fixed-wire dilatation catheter,
`guidewire, or other device, can be readily advanced through
`the inner lumen of the access catheter.
`There is little tendency for the catheter or guidewire
`which is advanced or withdrawn through the inner lumen of
`
`40
`
`LIIO
`
`60
`
`65
`
`4
`the access catheter of the invention to become bound-up
`within the inner lumen because the transverse cross—
`sectional shape of the inner
`lumen remains essentially
`circular when the access catheter, particularly the distal
`portion thereof, is configured into a curvature with a small
`radius of curvature, e.g. about 1 cm and even as small as
`about 0.5 cm, which may occur when the access catheter
`passes through the distal end of a guiding catheter with an
`Amplatz shape or when passing through tortuous coronary
`anatomy.
`These and other advantages of the invention will become
`more apparent from the following detailed description
`thereof, when taken in conjunction with the accompanying
`exemplary drawings.
`BRIEF DESCRIPTION OF TIIE DRAWINGS
`
`FIG. 1 is a longitudinal View, partially in section, of an
`exchange catheter embodying features of the invention.
`FIG. 2 is a transverse cross-sectional View of the
`exchange catheter shown in FIG, 1 taken along the lines
`2—2.
`FIG. 3 is schematic elevational View of a human heart
`with the left coronary artery partially cut—away demonstrat—
`ing a stenosis in the left anterior diagonal artery.
`FIG. 4 is an enlarged View of the stenotic region shown in
`FIG. 3.
`
`FIG. 5 is an elevational View, partially in section, of the
`distal portion of an alternative embodiment of the invention
`with rapid exchange capabilities.
`FIG. 6 is a view of the distal tip of the coil bonded to an
`adjacent turn of the coil.
`DETAILED DESCRIPTION OF TIIE
`INVENTION
`
`
`
`FIGS. 1 and 2 depict an access catheter 10 embodying
`eatures of the invention which generally includes an elon-
`gated catheter shaft 11 and an adapter 12 on the proximal
`end of the catheter. The catheter shaft 11 includes an inner
`ubular lining 13 which preferably has a lubricous inner
`surface defining an inner lumen 14, a helical coil 15 about
`he inner tubular lining which is stretched or longitudinally
`expanded at least in its distal portion to provide spaces 16
`between individual turns of the coil, and an outer jacket 17.
`The jacket 17 and the inner tubular lining 13 are bonded
`ogether by means of an adhesive 18 which is disposed in the
`spaces 16 between the turns of the coil 15. Alternatively the
`'acket 17 and inner tubular lining 13 may be joined together
`by he at bonding wherein the material thereof flows between
`he turns of the coil 15. The distal end of the coil 15
`erminates short of the distal end of the catheter shaft 11 and
`a relatively soft, non-traumatic distal tip 19 extends beyond
`he distal ends of the coil 15 and the inner lining 13. The
`non-traumatic tip 19 may be an extension of the jacket 17 as
`shown and may also be tapered.
`The distal portion of the catheter shaft 11 is provided with
`aerfusion ports 20 extending along a length of the catheter
`shaft which is to be disposed within the patient’s coronary
`artery, e.g. about 5 to about 40 cm. These perfusion ports are
`conveniently formed by a C02 laser which selectively burns
`away the jacket 17,
`the inner tubular lining l3 and the
`
`adhesive 18 which secures these two members together but
`
`
`does not significantly a ect the helical metallic coil 15.
`While a plurality of perfusion ports along the length of the
`distal portion of the ca heter shaft 11 are shown in the
`drawing, one elongated perfusion port could be employed to
`
`
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`Page 6
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`5,902,290
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`10
`
`15
`
`5
`replace a plurality of such ports. Moreover, perfusion ports
`may be provided disposed at various angles from one
`another. Additionally, they may be spirally arranged about
`the periphery of the catheter shaft 11, Generally, perfusion
`ports, guidewire ports and the like may be formed by means
`of a CO, CO2 or Eximer laser with an emitting light having
`a wave length of about 0.1 to about 12 microns will
`preferentially burn off the plastic material but will not affect
`metallic supporting elements such as the coil or braid of the
`present invention. If desired, e.g.
`to improve blood flow,
`other types of lasers with emitting light with shorter wave-
`lengths or other means may be employed to remove portions
`of the metallic coil 15 which are exposed by perfusion or
`guidewire ports.
`The materials of construction may be conventional. The
`jacket 17 may be a suitable thermoplastic polymer such as
`polyurethane, polyethylene, polyvinyl chloride and the like.
`The exterior of the jacket 17 may be provided with a
`lubricous coating such as a polysiloxane or suitable hydro-
`philic material. The inner tubular 13 member maybe formed
`of a fluoropolymer to provide lubricity to the inner surface
`thereof which forms the inner lumen 14. In the alternative,
`the inner tubular member may be formed of a thermoplastic
`polymer and the inner surface of the inner tubular member
`defining the inner lumen 14 may be provided with a lubri—
`cous coating as describe above for the exterior of the jacket
`17. The helical coil 15 may be in the form of a wire or ribbon
`and may be formed of 304 stainless steel or a superelastic
`nickel-titanium alloy which is frequently identified by the
`acronym NITINOI. (Nickel—Titanium Naval Ordnance
`Laboratory) or a high strength plastic material. A particu-
`larly suitable superelastic NITINOL is described in copend-
`ing application Ser. No. 07/629,381, liled Dec. 18, 1990
`entitled Superelastic Guiding Member which is incorporated
`by reference herein in its entirety. The free distal tip of the
`coil 15 is preferably joined, e.g. by laser welding or a
`suitable adhesive to an adjacent turn of the coil, as shown in
`FIG. 6, so as to preclude the possibility that the tip penetrate
`through the wall of the catheter and damage the artery
`through which the catheter is advanced. The laser welding
`may be preferred in view of ease of use, the high strength
`bonds which result and the small bond areas required,
`One presently preferred use of the access catheter 10 is
`illustrated in conjunction with FIGS. 3 and 4 which sche-
`matically illustrates a human heart 30 with portions of the
`ascending aorta 31 and the left coronary artery 32 cut away
`to show the guiding catheter 33 and the access catheter of the
`invention disposed therein. The distal portion of the guiding
`catheter 33 is disposed within the ascending aorta 31 with
`the distal tip thereof extending within the ostium 34. The
`access catheter 10 extends out the distal end of the guiding
`catheter 33 into the left coronary artery 32 of the patient to
`a location proximal to the stenotic site 35 in the left anterior
`diagonal branch 36.
`A fixed-wire balloon dilatation catheter 37 is advanced _
`out the distal end of the exchange catheter 10 over with the
`balloon 38 of the dilatation catheter extending across the
`stenosis 35. The balloon 38 is inflated one or more times to
`dilate the stenosis 35. If the dilatation catheter 37 needs to
`be exchanged, e.g. if the inflated diameter of the balloon 37
`is insufficient
`to completely dilate the stenosis 35,
`it
`is
`Withdrawn from the patient and a replacement dilatation
`catheter is advanced through the access catheter 10 to cross
`then dilate the stenosis 35.
`in facilitating the
`The access catheter is also useful
`advancement of a variety of catheters and elongated intra-
`vaseular devices through a tight passageway such as a lesion
`
`6
`by increasing the support and thus the pushability of the
`catheter or device.
`In order for the access catheter to be advanced through a
`guiding catheter and out into a patient’s coronary artery, the
`overall length of the access catheter must be longer, pref-
`erably at least about 5 cm longer than the guiding catheter
`used and at least about 2 cm shorter than the dilatation
`catheter or guidewire used. To facilitate the advancement of
`the access catheter through the inner lumen of the guiding
`catheter, the outer diameter of the access catheter must be
`smaller, preferably at least about 0.005 inch (0.127 mm)
`smaller, than the inner diameter of the guiding catheter. The
`inner diameter of the access catheter must be of sufficient
`size to allow a balloon dilatation catheter or other catheter or
`elongated device, which is to be used to perform the
`intravascular procedure, to be slidably advanced through the
`inner lumen of the access catheter. Typically, commercially
`available guiding catheters have lengths of about 100 cm,
`outer diameters at the distal extremity thereof of about 2.3
`to about 2.6 mm and inner diameters at the distal extremity
`of about 1.5 to about 2.2 mm. Commercially available
`balloon dilatation catheters typically have lengths of about
`135 cm and have a shaft outer diameter generally ranging
`from about 0.5 to about 1.3 mm. Commercially available
`guidewires typically have lengths of about 175 cm and
`diameters ranging from about 0.01 to about 0.018 inch
`(0.25—0.46 mm).
`In a presently preferred embodiment of the invention the
`catheter jacket
`is formed of polymers which provide a
`variable cured hardness along the length of the catheter shaft
`with the most proximal portion of the catheter shaft of about
`70 to about 100 cm in length having a hardness of about 40
`to about 90D Shore hardness and a distal section having a
`hardness of about 60 to about 100A Shore hardness. An
`intermediate section may be added with an intermediate
`hardness between the hardness of the proximal and distal
`sections.
`FIG. 5 illustrates an alternative embodiment of the access
`catheter 40 of the invention in a rapid exchange design
`which has a guidewire port 41 spaced a short distance, e.g.
`at least about 5 cm and preferably at least about 10 cm from
`the distal end of the catheter and a substantial distance from
`the proximal end of the catheter. The helical supporting coil
`42 is longitudinally expanded a greater distance than the coil
`15 shown in the previously discussed embodiment in the
`region of the proximal guidewire port 41 in order to accom-
`modate the passage of the guidewire 43 through the port 41.
`This embodiment may also be provided with perfusion ports
`(not shown) as in the previously discussed embodiment
`which are disposed between the proximal guidewire port 41
`and the distal end of the catheter 40. The helical coil 42 may
`extend just through the distal portion of the catheter 40 with
`the proximal extension of the coil terminating distal to the
`guidewire port 41.
`Progressively smaller diameter guiding catheters have
`been used in angioplasty, atherectomy and other intra coro-
`nary procedures over the years with the result that there has
`been less room within the inner lumen of the guiding
`catheters for delivery of radiopaque and other fluid through
`the inner lumen and out the distal end ofthe guiding catheter.
`Higher fluid pressure is required for effective delivery of the
`fluid. With the catheter of the present invention this effect
`can be minimized by extending the ports in the wall of the
`catheter along its length which is to be disposed within the
`inner lumen of the guiding catheter. In this manner the
`radiopaque fluid or for that matter any fluid which is
`introduced under pressure into the guiding catheter, will
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`enter into the inner lumen of the catheter of the invention
`through the ports in the wall and flow through the inner
`lumen and out the distal end thereof, thus allowing a greater
`overall fluid flow through the guiding catheter.
`While the present invention has been described herein in
`terms of certain preferred embodiments, diverted to a cath-
`eter which is used to give access to distal locations within a
`patient’s coronary anatomy,
`those skilled in the art will
`recognize that, a variety of modifications and improvements
`can be made to the invention without departing from the
`scope thereof.
`What is claimed is:
`1. An intravascular catheter for use within a patient’s
`coronary artery, comprising an elongated catheter shaft
`having a proximal shaft section and a flexible distal shaft
`section, a distal tip, a guidewire port in the distal tip and an
`inner lumen which extends through the distal shaft section to
`the guidewire port in the distal tip, with the flexible distal
`shaft section being dimensioned to facilitate its advancement
`through a patient’s coronary artery, having an outer plastic
`jacket, having a longitudinally expanded helical supporting
`coil within the outer jacket in the distal shaft section and
`provided with at least one opening in a wall portion of the
`plastic jacket which exposes at least part of one turn of the
`expanded helical supporting coil supporting part of the wall
`portion surrounding the opening and space between said turn
`and an adjacent turn which provides fluid communication
`from outside the catheter shaft to the inner lumen of the
`distal shaft section.
`2. The catheter of claim 1 wherein the supporting coil is
`formed from metallic wire or ribbon.
`3. The catheter of claim 2 wherein the metallic wire or
`ribbon is formed of a material selected from the group
`consisting of stainless steel and a superelastic alloy of nickel
`and titanium.
`4. The catheter of claim 1 wherein the jacket is a ther—
`moplastic polyurethane.
`5. The catheter of claim 1 wherein the supporting coil
`extends to a location proximal
`to the distal end of the
`catheter shaft.
`6. The catheter of claim 1 wherein the catheter shalt has
`an inner liner which defines at least in part the inner lumen
`and is formed of a thermoplastic fluoropolymer.
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`7. The catheter of claim 6 wherein the fluoropolymer is a
`polytetrafluoroethylene.
`8. The catheter of claim 1 wherein the exposed space
`between turns in at
`least one opening in the jacket
`is
`configured to facilitate movement of a guidewire there-
`through.
`9. The intravascular catheter of claim 1 wherein the
`longitudinally expanded helical support coil has a distal tip
`and a proximally adjacent turn with the distal tip bonded to
`the proximally adjacent turn.
`10. An intravascular perfusion catheter, comprising:
`a) an elongated catheter shaft having a distal tip, a port in
`the distal tip and an inner lumen which extends therein
`to the port in the distal tip;
`b) a proximal section of the elongated catheter shaft; and
`b) a flexible distal section of the elongated catheter shaft
`having an outer polymer jacket, a longitudinally
`expanded support coil within the outer polymer jacket
`and a plurality of perfusion openings in a wall portion
`of the outer polymer jacket each of which expose at
`least one turn of the expanded helical support coil
`supporting part of the wall portion surrounding the
`opening and space between the exposed turn and an
`adj acent turn of the helical support coil which is in fluid
`communication with the inner lumen of the catheter
`shaft.
`11. The catheter of claim 10 wherein the support coil is
`formed from metallic wire or ribbon.
`12, The catheter of claim 10 wherein the support coil
`extends to a location proximal to the distal end of the
`catheter shaft.
`13. The catheter of claim 10 wherein the catheter shalt has
`an inner liner which defines at least in part the inner lumen.
`14, The intravascular catheter of claim 13 wherein the
`inner liner is formed of a thermoplastic fluoropolymer.
`15, The intravascular catheter of claim 10 wherein the
`expanded helical support coil has a distal
`tip which is
`bonded to a proximally adjacent turn of the support coil.
`16. The intravascular catheter of claim 10 wherein the
`openings in the outer polymer jacket of the distal shaft
`section expose a plurality of turns of the expanded helical
`support coil.
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