United States Patent
`[19]
`[11] Patent Number:
`5,891,056
`
`Ramzipoor
`[45] Date of Patent:
`Apr. 6, 1999
`
`U8005891056A
`
`[54] GUIDEWIRE REPLACEMENT DEVICE
`WITH FLEXIBLE INTERMEDIATE SECTION
`
`Attorney, Agent, or Firm—Heller, Ehrman, White &
`McAuliffe
`
`[75]
`
`Inventor: Kama] Ramzipoor, Union City, Calif.
`
`[57]
`
`ABSTRACT
`
`[73] Assigncc: Advanced Cardiovascular Systems,
`Inc., Santa Clara, Calif.
`
`[21] Appl. N0.: 616,449
`
`[56]
`
`Mar 15 1996
`Filed'
`[77]
`'
`’
`i
`W
`Int. Cl-6 ..................................................... A6IB 5/00
`[51]
`[52] U-S- Cl- ~~~~~~~~~~~~~~~~~~~~~~~~~~ 600/585; 604/95; 604/280
`[581 Field Of Search ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ 128/772, 658,
`128/657; 604/95, 96’ 280> 281’ 282’ 283
`References Cited
`U.S. PATENT DOCUMENTS
`128/772
`2/1995 That el a].
`--------------
`
`604/283
`5/1995 VandenEinde et al
`. 128/772
`8/1995 Schwartz et a1.
`
`. 606/108
`9/1995 Chaisson et a1.
`7/1996 Ginn ................................ 128/772
`
`5,391,146
`q 415 639
`5:437:288
`5,449,362
`5,540,236
`
`FOREIGN PATENT DOCUMENTS
`
`7/1993 W1P0~
`W0 93/13827
`2/1996 WIPO -
`WO 96/04035
`Primary Examiner—Max Hindcnburg
`Assistant Examiner—Pamela S. Wingood
`
`A guidewire replacement device having a proximal shaft
`section, a distal shaft section and a flexible intermediate
`shaft section which facilitate the articulation of the distal
`
`shaft section with respect to the proximal shaft section. The
`
`intermediate shaft section has as aperture for the egress or
`exit of an in-place guidewire during a guidewire exchange.
`The proximal end of an in—place guidewire is inserted
`through the distal guidewire port in the distal end of the
`distal shaft section, through the distal section and out the
`aperture in the intermediate shaft section. The exchange
`dev1ce is advanced through the inner lumen of a guiding
`catheter over the in-place giiideWire until the distal end of
`the exchange device extends through the proximal guidewire
`port ofa rapid exchange type-intralummal catheter. Once the
`guideWire exchange dev1ce is properly placed, the in—place
`guidewire can then be withdrawn from the patient. The
`replacement guidewire can then be advanced through the
`inner luiiieii of the proximal shaft section,
`the guidewire
`
`passageway of the intermediate section, the inner lumen of
`the distal section into the guideWire receiVing inner lumen of
`the intraluminal catheter. The guidewire exchange device
`may then be removed from the patient.
`
`10 Claims, 3 Drawing Sheets
`
`
`
`Page 1
`
`Medtronic Exhibit 1018
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`Page 1
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`Medtronic Exhibit 1018
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`

`

`U.S. Patent
`
`Apr. 6, 1999
`
`Sheet 1 0f 3
`
`5,891,056
`
`
`
`Page 2
`
`Medtronic Exhibit 1018
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`Page 2
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`Medtronic Exhibit 1018
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`

`

`U.S. Patent
`
`Apr. 6, 1999
`
`Sheet 2 0f 3
`
`5,891,056
`
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`Page 3
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`Medtronic Exhibit 1018
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`Page 3
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`Medtronic Exhibit 1018
`
`
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`
`

`

`U.S. Patent
`
`Apr. 6, 1999
`
`Sheet 3 0f 3
`
`5,891,056
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`Page 4
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`Medtronic Exhibit 1018
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`Page 4
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`Medtronic Exhibit 1018
`
`
`

`

`5,891,056
`
`1
`GUIDEVVIRE REPLACEMENT DEVICE
`WITH FLEXIBLE INTERMEDIATE SECTION
`
`BACKGROUND OF THE INVENTION
`
`This invention generally relates to intravascular
`procedures, such as percutaneous transaluminal coronary
`angioplasty (PTCA), and particularly to the exchange of
`guidewires during such procedures.
`is
`In typical PTCA procedures, a dilatation catheter
`advanced over a guidewire, which is slidably disposed
`within an inner lumen of the dilatation catheter, 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
`across the lesion, the flexible, relatively inelastic balloon on
`the dilatation catheter is inflated to a predetermined size with
`radiopaque liquid at relatively high pressures (e.g., generally
`4—20 atmospheres or more) to dilate the stenosed region of
`the diseased artery. One or more inflations of the balloon
`may be required to complete the dilatation of the stenosis.
`After the last dilatation, the balloon is deflated so that the
`dilatation catheter can be removed from the dilated stenosis
`and blood flow can resume through the dilated artery.
`One significant improvement in dilatation catheters has
`been the introduction of rapid exchange type dilatation
`catheters. These catheters have a short guidewire receiving
`sleeve or inner lumen extending through the distal portion of
`the catheter which extend from a distal guidewire port in the
`distal end of the catheter to a proximal guidewire port spaced
`proximal to the proximal end of the dilatation balloon. The
`proximal guidewire port is usually located at least about 10
`cm and usually not more than about 50 cm from the distal
`guidewire port. A slit is preferably provided in the catheter
`wall in fluid communication with the guidewire receiving
`inner lumen which extends from the second guidewire port,
`preferably to a location proximal to the proximal end of the
`inflatable balloon to aid in the removal of the catheter from
`a guidewire upon withdrawal of the catheter from the
`patient. The structure of the catheter allows for the rapid
`exchange of the catheter without the need for the use of an
`exchange wire or adding a guidewire extension to the
`proximal end of the guidewire. The design of this catheter
`has been widely praised by the medical profession and has
`met with much commercial success in the market place
`because of its unique design. The rapid exchange type
`dilatation catheters of the assignee of the present invention,
`Advanced Cardiovascular Systems, Inc., have had a signifi-
`cant impact in the market for rapid exchange type dilatation
`catheters. Such products include dilatation catheters sold
`under the trademarks ALPHA, STREAK and ELIPSE.
`Rapid exchange type dilatation catheters are described
`and claimed in U.S. Pat. No. 5,040,548 (Yock), U.S. Pat. No.
`5,061,273 (Yock), U.S. Pat. No. 5,300,085 (Yock), U.S. Pat.
`No. 5,350,395 (Yock), U.S. Pat. No. 4,748,982 (IIorzewski
`et al.), U.S. Pat. No. 5,154,725 (Leopold) and U.S. Pat. No.
`5,346,505 (Leopold) which are incorporated herein in their
`entirety by reference.
`However, there is one significant inconvenience with the
`use of rapid exchange type dilatation catheter systems,
`namely, the inability to remove a guidewire already in place
`within a patient’s vaseulature during an angioplasty proce-
`dure without losing access to the vascular location. There
`has been no convenient way in which a replacement
`guidewire might be advanced through the vasculature and
`into the short guidewire receiving inner lumen in the distal
`extremity of a rapid exchange type dilatation catheter. These
`
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`instances occur when there is a need to replace an in-place
`guidewire with another guidewire having a different
`structure, e.g. from a floppy-type design with a separate
`shaping ribbon to an intermediate or standard with a core
`wire which extends to the distal tip of the guidewire. The
`need to withdraw an in-place guidewire also occurs when
`the distal tip of the in-placxe guidewire needs to be reshaped
`to change the angle of attach to a branch coronary artery.
`What has been needed and heretofore unavailable is a
`convenient means to withdraw an in-plaee guidewire from a
`rapid exchange type dilatation catheter and either replace the
`in-place guidewire with another guidewire or to reposition
`the in-plaee guidewire within the rapid exchange type dila-
`tation catheter. The present invention satisfies these and
`other needs.
`
`SUMMARY OF THE INVENTION
`
`
`
`This invention is directed to a guidewire exchange device
`for use with rapid exchange type catheters and t0 the use of
`this device, particularly during an intravascular procedure
`such as angioplasty.
`The guidewire exchange device of the invention generally
`comprises an elongated shaft with proximal and distal ends,
`a guidewire receiving inner lumen extending therein from
`the proximal end to a guidewire port in the distal end of tie
`catheter. The catheter shaft has an elongated proximal
`section, a relatively short distal section and a intermediate
`section which is capable of transmitting push from I16
`proximal shaft section to the distal shaft section and which
`is sufficiently axially flexible to allow the distal shaft section
`to be deflected away from the longitudinal axis of I16
`proximal shaft section, i.e. to facilitate the articulation of I16
`distal shaft section with respect to the proximal shaft section.
`This allows the proximal end of an in—place guidewire to 3e
`baek loaded through the distal shaft section and out an
`aperture or opening provided in the flexible intermediate
`shaft section. The guidewire exchange device can 36
`advanced over an in-plaee guidewire until the distal end of
`the distal shaft section of the device is seated in the proximal
`guidewire port of a rapid exchange type catheter. Preferab y,
`the distal shaft section is advance well into the guidewire
`receiving inner lumen of the rapid exchange type catheter. In
`this manner, the in—place guidewire can be readily removed
`from the patient by pulling on the proximal extremity
`thereof which extends out the proximal end of a guiding
`catheter without
`loss of access to the vascular location
`within the patient. A replacement guidewire can then be
`readily advanced through the guidewire lumen in the proxi—
`mal shaft section,
`the guidewire passageway through the
`intermediate shaft section, through the inner lumen of the
`distal shaft section and then into the guidewire lumen of the
`rapid exchange type dilatation catheter. At this point the
`guidewire exchange device may be withdrawn. However, it
`may be desirable to leave the guidewire exchange device
`connected to the rapid exchange type dilatation catheter in
`the event the replacement guidewire needs to be replaced.
`In the embodiment of the invention wherein the distal
`portion of the distal tubular member of the exchange device
`is adapted to be inserted into and be advanced through
`essentially the entire length of the relatively short guidewire
`receiving inner lumen of the readily exchangeable catheter
`is particularly suitable for use with a rapid exchange type
`dilatation catheters having perfusion ports, as described in
`the previously discussed McInnes et a1. applications incor—
`porated herein, which allow blood to pass through the
`guidewire receiving inner
`lumen. When using rapid
`
`Page 5
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`Medtronic Exhibit 1018
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`Page 5
`
`Medtronic Exhibit 1018
`
`

`

`5,891,056
`
`3
`exchange type dilatation catheters With perfusion ports in the
`catheter shaft, advancement of a replacement guideWire
`within the guideWire receiving inner lumen sometimes
`results in the passage of the guideWire out one of the
`perfusion holes in the catheter wall rather than the guideWire
`port
`in the distal end of the catheter. When the distal
`extremity of the guideWire exchange device of the invention
`is positioned within the guideWire receiving inner lumen of
`the readily exchangeable catheter,
`the replacement
`guideWire is directed to the distal guideWire port through the
`exchange device and cannot be advanced out one of the
`perfusion ports.
`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 THE DRAWINGS
`
`FIG. 1 is an elevational view of the guideWire exchange
`device of the invention.
`FIG. 2 is a transverse cross-sectional View of the device
`shown in FIG. 1 taken along the lines 2—2.
`FIG. 3 i s an enlarged transverse cross-sectional View of
`the device shown in FIG. 1 taken along the lines 3—3.
`FIG. 4 is a longitudinal view of the device shown in FIG.
`2 taken along the lines 4—4 with a stiffening mandrel
`extending through an inner lumen of the proximal shaft
`section of the device.
`FIG. 5 is an elevational View of the device shown in FIGS.
`1—4 with an in-place guidewire extending Within the distal
`shaft section and passing through turns of the coil intercon-
`necting the proximal and distal shaft sections.
`FIG. 6 is an elevational view, partially in section, of the
`guidewire exchange device shown in FIG. 1 within a guiding
`catheter and with the distal shaft section proximally adjacent
`to a proximal guideWire port of a rapid exchange type
`dilatation catheter.
`
`FIG. 7 is an enlarged longitudinal cross-sectional view
`showing the distal section of the exchanged device extend-
`ing within the guideWire receiving lumen of a rapid
`exchange type dilatation catheter.
`FIG. 8 is an elevational view, partially in section, of an
`alternative embodiment of the invention wherein the flexible
`intermediate shaft section of the exchange device is a tubular
`member with transverse slots therein.
`
`DETAILED DESCRIPTION OF THE
`INVENTION
`
`Reference is made to FIGS. 1—6 which depict a guideWire
`exchange device 10 embodying features of the invention.
`The exchange device 10 includes a relatively long proximal
`shaft section 11, a relatively short distal shaft section 12 and
`a flexible intermediate shaft section 13 which interconnects
`the distal end of the proximal shaft section to the proximal
`end of the distal shaft section. As shown in FIG. 2, the
`proximal shaft section 11 preferably has an oval shaped
`transverse cross-section with a first guideWire receiving
`lumen 14 and a second lumen 15 which receives a stiffening
`mandrel 16. A peel-away slit 17 is provided along a sub-
`stantial length of the proximal shaft section 11 to facilitate
`removal of the device from a replacement guideWire at the
`end of the guideWire exchange procedure which will be
`discussed further below. The distal shaft section 12 of the
`exchange device 10 is relatively short and has an guideWire
`receiving lumen 18. The intermediate shaft section 13 is
`
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`preferably a helical coil which may be formed of suitable
`material such as stainless steel, NITINOL or a high strength
`plastic material. The guideWire passageway 19 defined by
`the coil of the intermediate shaft section 13 extends from the
`proximal end of the distal section 12 to the distal end of the
`proximal shaft section 11 and interconnects the guideWire
`receiving lumen 14 of the proximal shaft section with the
`guideWire receiving lumen 18 in the distal shaft section.
`While not shown in the drawings, the proximal end of the
`intermediate shaft section 13 is preferably bonded by a
`suitable adhesive to the distal end of the proximal shaft
`section and the distal end of the intermediate shaft
`is
`similarly bonded to the proximal end of the distal shaft
`section. The proximal end of the intermediate shaft section
`13 may be provided with an oval cross-sectional shape to
`facilitate placement onto the distal end of the oval shaped
`proximal shaft section 11. Aperture 20 is formed by the
`expanded turns of the coil.
`The guideWire exchange procedure with the exchange
`device of the present invention is best described with respect
`to FIGS. 5—7, When the operating physician wishes to
`exchange an in-place guideWire 21 during an angioplasty or
`other intraluminal procedure using a rapid exchange type
`catheter, the proximal end of the in-place guideWire, which
`is located outside of the patient, is first introduced through
`the guideWire port 22 in the distal end of the distal shaft
`section 12 into the guideWire receiving lumen 18 extending
`in the distal shaft section and into the passageway 19 at least
`partially defined by the coil of the intermediate shaft section
`13. The distal shaft section 12 is manually deflected so as to
`guide the advancing proximal end of the in-plaee guideWire
`21 though the aperture 20 defined by adjacent turns of the
`coil. The proximal end of the in-place guideWire 21 is then
`held while the exchange device 10 is pushed from the
`proximal shaft section 11, which extends out of the patient,
`so as to advance the distal section 12 over the in—place
`guideWire 21 until the distal shaft section 12 of the exchange
`device 10 extends through the proximal guideWire port 23 of
`the dilatation catheter 24 and into the guideWire receiving
`inner lumen thereof 25, as shown in FIG. 7. The dilatation
`catheter 24 is preferably positioned within the patient so that
`the proximal guideWire port 23 thereof remains within the
`inner lumen 26 of the guiding catheter 27 as shown in FIG.
`6. With the guideWire exchange device 10 disposed prefer-
`ably well within the guideWire lumen 25 of the dilatation
`catheter 24, the in-place guideWire 21 may then be With-
`drawn from the patient by pulling on the proximal extremity
`of the guideWire which extends out of the patient. A replace-
`ment guideWire 28, shown in FIGS. 6 and 7, may then be
`advanced out of the proximal shaft section 11, through the
`distal shaft section 12, such as shown in FIG. 5, until the
`distal section of the replacement guideWire is disposed
`within the guideWire receiving lumen of the dilatation
`catheter 24. The guideWire exchange device 10 may then be
`withdrawn from the patient by pulling on its proximal end
`leaving the replacement guideWire 28 in place. The replace-
`ment guideWire 28 maybe positioned within the lumen 14
`of the proximal shaft section 11 before the guideWire
`exchange device 10 is introduced into the patient or it may
`be introduced into the proximal shaft section 11 after the
`guideWire exchange device is advanced into position within
`the patient.
`
`When the guideWire exchange device 10 is withdrawn
`
`
`from the patient,
`the device is pulled o
`the guideWire
`though the peel away slit 17 provided in the proximal shaft
`section 11. As the proximal extremity of he replacement
`guideWire 28 is exposed distal
`to the distal end of the
`
`
`
`Page 6
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`Medtronic Exhibit 1018
`
`Page 6
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`Medtronic Exhibit 1018
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`

`

`5,891,056
`
`5
`exchange device 10, the guidewire is manually grasped by
`the physician so that
`the device 10 can be completely
`removed from the guidewire. If desired the exchange device
`10 may be left in the patient just in case the replacerrient
`guidewire needs to be replaced.
`'lhe proximal shaft section 11 is preferably formed from
`a high density polyethylene, although other conventional
`polymers used in forming catheter shafts may be employed
`such as polyvinyl chloride and co-polyesters (Hytrel). Stain-
`less steel, NITTNOL and fiber reinforced composite con-
`structions are also suitable. The proximal shaft section 11 is
`about 80 to about 140 cm in length, preferably about 90 to
`about 110 cm. The major axis of the elliptical transverse
`cross-section in about 0.045 to about 0.075 inch (1.1—1.9
`mm), preferably about 0.055 to about 0.065 inch (1.4—1.7
`mm) and the minor axis thereof is about 0.02 to about 0.04
`inch (0.5—1.0 mm), preferably about 0.025 to about 0.35
`inch (0.6—0.9 mm) in diameter. The guidewire receiving
`lumen 14 has a preferred diameter of about 0.012 to about
`0.022 inch (030—06 mm) and the mandrel receiving lumen
`15 has a preferred diameter of about 0.012 to about 0.022
`inch. The mandrel 16 preferably has essentially the same
`diameter of the second lumen 15. The mandrel 16 may be
`formed of suitable high strength materials such as stainless
`steel, NITINOL and high strength polymer materials. When
`the proximal shaft section 11 is formed of stainless steel,
`NITINOL and the like the mandrel 16 may be unnecessary,
`in which case the dual lumen and the oval shape of the
`proximal shaft section also become unnecessary.
`The distal shaft section 12 is preferably relatively stiff to
`facilitate its advancement into the guidewire port of a rapid
`exchange type catheter. It may be formed of polyimide,
`stainless steel, NITINOL or other suitable high strength
`materials. The distal shaft section 12 is short in comparison
`With the proximal shaft section 11 and is generally about 1.5
`to about 4 cm, preferably about 1.5 to about 3 cm in length.
`The guidewire receiving lumen 18 has a diameter about
`0.012 to about 0.022 inch (0.3—0.6 111111) and may be slightly
`smaller than the lumen 18 in the proximal shaft section 11.
`If the distal shaft section 12 is formed of polyimide, the wall
`thickness thereof may be about 0.0005 to about 0.0015 inch
`(0013—0038 mm).
`The readily exchangeable dilatation catheter 24 can be
`exchanged for another readily exchangeable dilatation cath—
`eter over either the in-place guidewire 21 or the replacement
`guidewire 28.
`FIG. 8 illustrates an alternative embodiment wherein the
`intermediate shaft section 33 is provided with a plurality of
`transverse slots 34 to provide the flexibility required for the
`articulation of the distal shaft section 12. While slots 34 are
`shown in this embodiment on both sides of the intermediate
`shaft section 33, slots may be formed on only one side to
`provide articulation in only one direction, if desired.
`While the invention has been described herein in terms of
`a guidewire exchange device which facilitates guidewire
`replacement in a readily exchangeable dilatation catheter,
`those skilled in the art will recognize that the exchange
`device can be used with a variety of intraluminal catheters
`having rapid exchange features. Other modifications and
`improvements can he made to the invention without depart-
`ing from the scope thereof.
`What is claimed:
`1. Aguidewire exchange device having an elongated shaft
`comprising:
`a) an elongated proximal shaft section with a first
`guidewire receiving inner lumen extending therein;
`
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`6
`b) a short distal shaft section with a distal end, a port in
`the distal end and a second guidewire receiving inner
`lumen extending therein and in fluid communication
`with the port in the distal end; and
`c) a flexible intermediate shaft section having a guidewire
`passageway interconnecting the first guidewire receiv-
`ing inner lumen of the proximal shaft section and the
`second guidewire receiving inner lumen of the distal
`shaft section and an aperture in a side wall of the
`flexible intermediate shaft section configured for pas-
`sage of a guidewire therethrough upon articulation
`about a longitudinal axis of the distal sh aft section with
`respect to the proximal shaft section, the intermediate
`shaft section being sufficiently flexible to facilitate
`articulation of the distal shaft section With respect to t 1e
`proximal shaft section in any direction about said
`longitudinal axis and being sufficiently axially rigid to
`transmit axial push from he proximal shaft section to
`the distal shaft sec ion to acilitate advancement of tie
`distal shaft section into a aroximal guidewire port of a
`rapid exchange type catheter.
`2. The guidewire exc iange cevice of claim 1 wherein tie
`aperture in the wall of the intermediate shaft section is
`spaced proximally at least about 1 cm from the guidewire
`port in the distal end 0 the distal shaft section.
`3. The guidewire exc iange cevice of claim 1 wherein tie
`intermediate shaft section is a helical coil.
`4. The guidewire exe iange cevice of claim 3 wherein tie
`egress aperture in the side wall of the intermediate shaft
`section is formed by expanded adjacent turns of the helical
`coil.
`5. The guidewire exc iange cevice of claim 1 wherein tie
`distal shaft section is configured to be advanced within a
`guidewire receiving inner lumen of a rapid exchange ty 3e
`catheter.
`6. The guidewire exc iange cevice of claim 1 wherein tie
`intermediate shaft section is a tubular member having a
`plurality of transverse slots therein configured for passage of
`a guidewire.
`7. A method for exchanging a guidewire during an angio—
`plasty procedure wherein a readily exchangeable dilatation
`catheter having a short guidewire receiving inner lumen in
`the distal portion thereof extending between a distal
`guidewire port in the distal end of the dilatation catheter and
`a proximal guidewire port spaced a short distance from the
`distal guidewire port, is disposed Within a patient’s vascu-
`lature and wherein an in-place guidewire having proximal
`and distal ends extends through the short guidewire receiv-
`ing inner lumen within the distal portion of dilatation
`catheter, the method comprising:
`a) providing a guidewire exchange device having an
`elongated shaft comprising
`an elongated proximal shaft section with a first
`guidewire receiving inner lumen,
`a short distal shaft section with a guidewire port in the
`distal end and a second guidewire receiving inner
`lumen extending therein and in fluid communication
`with the guidewire port in the distal end, and
`a flexible intermediate shaft section having a guidewire
`passageway interconnecting the first guidewire
`receiving inner lumen of the proximal section and
`the second guidewire receiving inner lumen of the
`distal shaft section and a guidewire egress aperture in
`a side wall of the flexible intermediate shaft section,
`and being sufficiently flexible to facilitate articula—
`tion of the distal shaft section with respect to the
`proximal shaft section and being sufficiently axially
`
`Page 7
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`5,891,056
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`LII
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`b) advancing the guidewire replacement device over the
`guidewire until the distal end of the guidewire replace-
`ment device is seated within the proximal guidewire
`port in the catheter through which the guidewire exits;
`c) withdrawing the in-place guidewire;
`d) advancing a replacement guidewire through an inner
`lumen extending within the guidewire replacement
`device,
`through the proximal guidewire port
`in the
`catheter and out the distal guidewire port in the cath—
`
`7
`rigid to transmit axial push from the proximal shaft
`section to the distal shaft section to facilitate
`advancement of the distal shaft section through a
`proximal guidewire port of a rapid exchange type
`dilatation catheter;
`b) advancing the proximal end of the in-place guidewire
`through the port in the distal end of the distal shaft
`section and the second guidewire receiving inner lumen
`and into the passageway of the intermediate shaft
`section until the proximal end of the in-place guidewire 10
`eter;
`extends out
`the egress aperture in the wall of the
`e) withdrawing the guidewire replacement device from
`intermediate shaft section;
`the patient;
`c) advancing the guidewire exchange device over the
`f) peeling the guidewire replacement device from the
`in—place guidewire until the distal end of the distal shaft
`replacement guideWire through the peel-away slot pro-
`section of the exchange device at least enters into a 15
`vided in the wall of the proximal tubular section of the
`proximal guidewire port of the dilatation catheter;
`guidewire replacement device as it exits the patient;
`d) withdrawing the in-place guidewire through the
`and
`guidewire exchange device by pulling the in-place
`g) further withdrawing the guidewire placement device
`guidewire from its proximal end WhiCh extends 01” 0f 20
`over the replacement guidewire until the distal end of
`the patient; and
`the placement device exits the patient, manually secur-
`f) advancing a replacement guidewire through the first
`ing the exposed portion of the replacement guidewire
`guidewire receiving inner lumen 0f the proximal shaft
`distal to the distal end of the replacement device and
`section 0f the guidewire exchange dCViCCafhmugh the
`then removing the replacement device from the
`passageway Oh the intermediate shaft SCChOh’ through 25
`replacement guidewire.
`the second guidewire receiVing inner lumen. in distal
`9.Aguidewire exchange device having an elongated shaft
`shaft section and into a guideWire rece1V1ng inner
`comprising
`lumen of the dilatation catheter.
`'
`.
`.
`.
`8. A method for exchanging a guidewire disposed within
`a) an elongated. proximal shaft SCCIIOH. Whh a. first
`a short guidewire receiving inner lumen in the distal portion 30
`guideWire rece1V1ng inner lumen extending therein;
`of an intravascular catheter which is placed within a patient
`b) a short distal shaft section with a distal end, a port in
`during an intravascular procedure comprising:
`the distal end and a second guidewire receiving inner
`a) providing a guideVVn'e replacement device having an
`lumen extending therein and in fluid communication
`elongated shaft comprising
`with the port in the distal end; and
`an elongated proximal shaft section with a first 35
`c) a flexible intermediate shaft section comprised of a
`guidewire receiving inner lumen and a peel-away
`helical coil having a guidewire passageway intercon—
`5101 extending. longitudinally. Whi?h is in .flhid com-
`necting the first guidewire receiving inner lumen of the
`munication Whh the hFSt guideWire receivmg inner
`proximal section and the second guidewire receiving
`lumenextending therein, .
`.
`.
`.
`inner lumen of the distal shaft section and an aperture
`a Shhrt dIStal shaft SCCHOH Wlth. a guideWireport 1h the 40
`.
`'d
`7 ll
`fth fl
`'bl
`.
`t
`d'
`t
`h ft
`t'
`distal end and a second guideWire receiVing inner
`0
`In a S] e vs a
`e
`6X1
`e in “he 1a e S a
`.sec ion
`lumen extending therein and in fluid communication
`configured for egress Of a guideWire slidably disposed
`with the guidewire port in the distal end, and
`Wlthm the guideWire passageway,
`the intermediate
`a flexible intermediate shaft section having a guidewire
`shaft section bung sufl1c10ntly .fiex1ble to fac111tate
`passageway interconnecting the first guidewire 45
`articulation of the distal shaft section With respect to the
`receiving inner lumen of the proximal section and
`hquhhal shaft section and being suffic1ently ax1ally
`the second guidewire receiving inner lumen of the
`rlgld to transmit ax1al push from the prox1mal shaft
`distal shaft section and a guidewire egress aperture in
`SCCtiOh t0 the distal shaft section to facilitate advance—
`a side wall of the flexible intermediate shaft section,
`ment 0f the distal shaft SCChOh through a proximal
`and being sufficiently flexible to facilitate articula- 50
`guidewire port of a rapid exchange type catheter.
`tion of the distal shaft section with respect to the
`10. The guidewire exchange device of claim 9 wherein the
`proximal shaft section and being sufliciently axially
`egress aperture in the side wall of the intermediate shaft
`rigid to transmit axial push from the proximal shaft
`section is formed by expanded adjacent turns of the helical
`section to the distal shaft section to facilitate
`advancement of the distal shaft section through a 55 coil.
`proximal guidewire port of a rapid exchange type
`dilatation catheter;
`
`Page 8
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`Medtronic Exhibit 1018
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`Page 8
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`Medtronic Exhibit 1018
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`