throbber
[19]
`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
`
`
`1111'?“
`
`
`'9'
`=v-m Efiigi/‘W
`
`,
`
`4|
`
`Page 1
`
`Medtronic Exhibit 1417
`
`Page 1
`
`Medtronic Exhibit 1417
`
`

`

`US. Patent
`
`May 11, 1999
`
`Sheet 1 0f 3
`
`5,902,290
`
`llll..
`
`l..:~.-.-~.i!§-h!=l=_‘g:--§-~
`
`
`Illlll'l:lllllllAll-IE-I..._~,|lllllll.l_.lllll‘““‘~....‘..‘~‘..~‘...‘~.‘~....lII“|“\3llI1h,.I,I\
`alililzla!"I’IIZIEIZIZIZIV-‘IZIZIZII
`
`
`
`
`
`{iiiEt‘EsEel!
`
`V‘IV‘IV‘IV''3'III’JIF!IEIP‘|‘lalalE'I'EIV!IEI.II.IIII.I
`
`
`
`..IIIIlIII
`
`'fi“\\!\“:§:§lill.1:.xiifililfl‘11‘txalllI'IHIoI
`=_i“:~\§§---’
`
`
`
`
`I'll
`
`.......
`
`m_ON
`
`
`
`
`
`L.
`
`Page 2
`
`Medtronic Exhibit 1417
`
`Page 2
`
`Medtronic Exhibit 1417
`
`
`
`

`

`US. Patent
`
`May 11, 1999
`
`Sheet 2 0f 3
`
`5,902,290
`
`
`
`Page 3
`
`Medtronic Exhibit 1417
`
`Page 3
`
`Medtronic Exhibit 1417
`
`

`

`US. Patent
`
`May 11, 1999
`
`Sheet 3 0f 3
`
`5,902,290
`
`
`
`(C1!
`'0.
`:\
`
`
`FIG.4
`
`
`
`V
`
`I
`
`Page 4
`
`Medtronic Exhibit 1417
`
` A
`
`
`
`
`
`
`
`
`"HIIIIO.;;V;.‘\
`
` l'Iu”.
`
`
`
`
`Page 4
`
`Medtronic Exhibit 1417
`
`

`

`5,902,290
`
`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
`
`LIILA
`
`60
`
`Page 5
`
`Medtronic Exhibit 1417
`
`Page 5
`
`Medtronic Exhibit 1417
`
`

`

`5,902,290
`
`10
`
`15
`
`
`
`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
`
`
`
`Page 6
`
`Medtronic Exhibit 1417
`
`Page 6
`
`Medtronic Exhibit 1417
`
`

`

`5,902,290
`
`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
`
`40
`
`LIIO
`
`60
`
`65
`
`Page 7
`
`Medtronic Exhibit 1417
`
`Page 7
`
`Medtronic Exhibit 1417
`
`

`

`5,902,290
`
`7
`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.
`
`8
`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.
`
`10
`
`15
`
`40
`
`Page 8
`
`Medtronic Exhibit 1417
`
`Page 8
`
`Medtronic Exhibit 1417
`
`

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket