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`US005413560A
`.
`5,413,560
`[11] Patent Number:
`[19]
`United States Patent
`
`Solar
`[45] Date of Patent:
`May 9, 1995
`
`[54] METHOD OF RAPID CATHETER
`EXCHANGE
`
`[75]
`
`Ronald J. Solar, San Diego, Calif.
`Inventor:
`.
`.
`,
`Pameda N.V., Netherlands Antilles
`[73] Asmgnee.
`[21] Appl, No.: 965,593
`.
`[22] Filed:
`Oct. 26, 1992
`
`[62]
`[51]
`52
`
`Related u_s_ Application Data
`Division of Ser. No. 859,220, Mar. 30, 1992.
`Int. Cl.6 .................... A61M 5/178; A61M 29/00;
`A61F 2/06
`.
`.
`. ........................................
`-
`-
`] US Cl
`624216640063/51/92
`[
`[58] Field of Search
`606/191-199'
`604/96 164- 623/1
`
`[561
`
`.
`
`.
`
`References Cited
`U.S. PATENT DOCUMENTS
`3,906,93
`'
`.
`8 9/1975 HC‘SChhaCker
`3,973,556 8/1976 Fleischhacker .
`4,538,622 9/1985 Samson et a].
`_
`4,545,390 10/1985 Leary .
`4,554,929 11/1985 Samson et al.
`4:601,713 7/ 1986 Fug“? -
`4,619,274 10/1986 Morrison .
`4,719,924 6/ 1988 Crittenden et a1.
`4,757,827 7/1988 Buchbinder et al.
`4,762,129 8/1988 Bonzel
`.
`
`'
`
`.
`
`.
`.
`
`4,813,434 3/1989 Buchbinder et al.
`4,815,478
`3/1939 Buchbinder et a1,
`4,820,349 4/1989 Saab .
`.
`4,944,740 7/1990 Buchbinder et al.
`4,954,126
`9/1990 Wallsten ......................... 606/191 x
`
`4,976,689 12/1990 Buchbinder et a].
`_
`
`606/192 x
`2/1991 MacGregor ............
`4,994,071
`606/192 X
`5,035,694
`7/1991 Kasprzyk et all
`5,040,548
`8/1991 Yock .
`5,089,005 2/1992 Harada ................. 606/192 X
`
`..... 606/ 194
`5,108,416 4/1992 Ryan et al.
`.................... 606/194
`5,135,535
`8 1992 K1"
`/
`amer
`FOREIGN PATENT DOCUMENTS
`0452901 10/1991 European Pat. Off.
`............ 606/194
`Primary Examiner—Randall L. Green
`Assistant Examiner—Elizabeth M. Burke
`Attorney, Agent, or Firm—Cowan, Liebowitz & Latman
`
`ABSTRACI‘
`[57]
`The invention relates to a rapid exchange catheter sys-
`tem comprising a exchange member having proximal
`.
`.
`.
`.
`.
`and distal ends, the d1stal end of the ngid shaft being
`integral with the proximal end of the exchange member,
`such that said shaft is adapted to advance the exchange
`member distally to a desired location wherein the ex—
`change member is positioned concentrically to a cathe-
`ter shaft.
`
`7 Claims, 3 Drawing Sheets
`
`vvr/'-.
`' 1.1.111151.1141111111111181?
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`US. Patent
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`May 9, 1995
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`Sheet 1 of 3
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`FIG. 4
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`FIG. 5
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`FIG. 6
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`US. Patent
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`May 99 1995
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`Sheet 2 0f 3
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`US. Patent
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`1 May 9, 1995 *
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`Sheet 3 of 3
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`33
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`FIG. 9
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`1
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`5,413,560
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`NIETHOD OF RAPID CATHETER EXCHANGE
`
`CROSS—REFERENCE TO RELATED
`APPLICATION
`
`This application is a divisional of co-pending US.
`patent application Ser. No. 07/859,220, filed Mar. 30,
`1992.
`
`FIELD OF THE INVENTION
`
`This invention relates to a rapid exchange catheter
`system. More particularly, this invention relates to a
`rapid exchange catheter system comprising one or more
`balloon dilatation catheters and an exchange facilitator
`consisting of an elongated exchange member and a rigid
`shaft.
`
`BACKGROUND OF INVENTION
`
`In the utilization of catheters to diagnose and treat
`various medical disorders, it is very often required that
`more than one device be used during the procedure.
`Because positioning of the catheter at the desired loca-
`tion may be difficult, time consuming, or critical or pose
`a high risk, techniques have been developed that facili-
`tate exchange of catheter devices.
`The most common technique for catheter exchange
`employs a very long guidewire called an exchange wire.
`In this technique the exchange wire is placed within a
`central lumen of a catheter that has been previously
`positioned within the body. To maintain the desired
`position, the exchange wire is advanced while the cath-
`eter is simultaneously withdrawn. Once the catheter is
`completely out of the body, it is removed from the
`exchange wire. A second catheter is then positioned
`over the exchange wire, and, once the catheter is com-
`pletely on the exchange wire, it is then advanced to the
`desired site in the body. This over-the-wire technique
`for catheter exchange is considerably time consuming,
`and it requires at least two operators to effect the ex—
`change. In addition, the very long exchange wire ex-
`tends beyond the sterile field, which adds to the risk of
`contamination during the procedure.
`US. Pat. No. 4,762,129 to Bonzel and U.S. Pat. No.
`5,040,548 to Yock describe balloon angioplasty cathe-
`ters that can be exchanged over a standard length guide-
`wire. These catheters are called monorail catheters, and
`they are designed such that only a relatively short seg-
`ment of the distal end of the catheter is advanced over
`the guidewire, i.e., the catheter has a lumen to receive
`the guidewire that extends from the distal tip of the
`catheter to a location proximal to the balloon. Since the
`length of the guidewire used is only about half that of an
`exchange wire, the catheter exchange can be done more
`quickly, and a single operator may do the exchange.
`However, since a much shorter segment of the catheter
`is concentric to the guidewire, the monorail-type cathe-
`ters have diminished axial support for tracking the
`guidewire (trackability) and transmission of axial or
`longitudinal forces (pushability).
`In addition to the drawbacks cited above, both of the
`catheter exchange techniques described above have
`two additional shortcomings—increased diameter of
`the catheters to accommodate the guidewire, and risk of
`vessel trauma resulting from repeated catheter passages.
`In a number of applications, over—the-wire catheters are
`too large to be placed at the desired location. In these
`applications, smaller catheters, whose diameters have
`been reduced by eliminating the guidewire lumen, have
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`been required. Exchange with these prior art systems
`consisted essentially of starting over after the first cath—
`eter was removed. This is often time consuming, and
`there is an increased risk of complications resulting
`from vessel
`trauma. US. Pat. Nos. 4,944,740 and
`4,976,689 addressed the trauma issue by providing an
`outer tubular sheath concentric to an inner catheter.
`However, this system would have very limited applica-
`tion in small blood vessels, as the system itself would
`occlude the blood vessel and cause ischemic complica-
`tions. Moreover, the outer tubular sheath must be used
`as a system with its inner catheter; if another catheter or
`guidewire was used initially, this system could not make
`the exchange.
`OBJECTS OF THE INVENTION
`
`It is an object of this invention to provide an atrau-
`matic rapid exchange catheter system.
`.
`It is also an object of this invention to provide a rapid
`exchange catheter system comprising an exchange
`member and a pushing shaft.
`It is a further object of this invention to provide a
`rapid exchange catheter system comprising an exchange
`member, a pushing shaft, an expandable sheath mem-
`brane, and a hemostasic manifold.
`It is a yet further object of this invention to provide a
`method for the rapid exchange of exchange members,
`such as catheters, guidewires and other devices.
`These and other objects of the invention will become
`more apparent in the discussion below.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`FIGS. 1 and 2 each represent lateral, longitudinal
`views of respective embodiments of the invention;
`FIG. 3 represents a cross-sectional view of the em-
`bodiment of FIG. 1;
`FIGS. 4, 5, and 6 represent additional cross—sectional
`views of embodiments of the invention;
`FIG. 7 represents an additional embodiment of the
`invention with the sheath collapsed;
`FIG. 8 represents the embodiment of FIG. 7 with the
`sheath expanded; and
`FIGS. 9 and 10 represent cross-sectional views of a
`further embodiment of the invention.
`
`DETAILED DESCRIPTION OF THE
`INVENTION
`
`The rapid exchange catheter system (RECS) of this
`invention provides a very rapid, atraumatic means of
`exchanging one balloon dilatation catheter or other
`device for another balloon dilatation catheter or other
`device. The RECS is comprised of (1) a distal exchange
`member, preferably radiopaque, and (2) a rigid shaft or
`wire attached to the exchange member. Optionally the
`RECS may also comprise (3) a membrane sheath, which
`is folded around and attached along the length of the
`rigid shaft, and (4) a hemostatic manifold in fluid con-
`nection with the membrane sheath.
`The RECS is used by, first, placing the exchange
`member over the proximal portion of the shaft of a
`catheter, e.g., a balloon dilatation (PTCA) catheter, or
`a guidewire or other device, that is to be withdrawn
`from a patient. Then, the exchange member is advanced
`distally along the shaft until the exchange member is
`positioned at the target site, i.e., adjacent to or across a
`stenosis, by pushing the rigid wire. The catheter, guide-
`wire, or other device is withdrawn, and then, if a mem-
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`brane sheath is present, the sheath is unfolded by flush-
`ing through the hemostatic manifold.
`Now, subsequent PTCA catheters, guidewires, or
`other devices, for example, atherectomy catheters, laser
`catheters, stents, angioscopic or ultrasound imaging
`catheters, infusion catheters, perfusion catheters, or the
`like, may be passed through the sheath to the target site.
`Additional exchanges can be made as desired through
`the sheath. Since such additional exchanges are made
`within the sheath, the subsequent catheters and other
`devices that are introduced do not rub against the in-
`tima of the arteries, as happens with both over—the-wire
`and monorail exchange techniques. The exchanges with
`the RECS are rapid and atraumatic, with the possibility
`of endothelial denudation, plaque, and intimal dissec-
`tion minimized.
`In addition to providing a rapid and atraumatic means
`for exchanging catheters and other devices, the RECS
`of the invention can also be used for subselective infu—
`sion and perfusion Subselective infusion of various
`pharmacological agents directly to a lesion, especially
`during a procedure,'may reduce complications, mini—
`mize systemic side-effects, and improve the long-term
`outcome of the procedure. In the event of an abrupt
`closure during an angioplasty, the RECS can be rapidly
`deployed to provide coronary perfusion. With the
`sheath in the collapsed, folded position, the distal ex-
`change member can act as a temporary stent, providing
`passive perfusion. If necessary, blood or an oxygen-
`bearing fluid could be pumped through the sheath for
`active perfusion.
`With the ability to perfuse, the RECS can provide
`lifesaving capability not presently available in known
`exchange systems. Patients can be stabilized, and the
`requirement of surgical standby for PTCA could be
`reduced or eliminated. In addition to significantly re-
`ducing the cost of a PTCA procedure, the reduction or
`elimination of the surgical standby requirement would
`facilitate increasing the number of PTCA procedures
`performed each year.
`The invention can perhaps be better understood by
`makingreference to the drawings. The embodiment of
`the invention 1 shown in FIG. 1 comprises an exchange
`member 2 and a rigid shaft, or corewire, 3 for advancing
`and/or retracting the exchange member 2 to and/or
`from the target area in the vasculature (not shown). The
`shaft 3 is preferably a wire. Exchange member 2 com—
`prises a tubular member here; however, exchange mem-
`ber 2 can be comprised of any structure that defines a
`lumen suitable for exchange purposes.
`Another embodiment of the invention 4 can be seen
`in FIG. 2, wherein the exchange member is comprised
`of coil 5. Coil 5, which is preferably helically wound, is
`either continuous with shaft 6, that is, formed from the
`same wire, or is another wire attached to shaft 6, prefer-
`ably by solder, glue, a weld, or similar affixation. In an
`alternate embodiment, coil 5 is butt joined to shaft 3.
`FIG. 3 represents a cross-sectional view of exchange
`member 2, wherein it can be seen that shaft 3 is affixed
`to the interior surface 7 of exchange member 2. The
`distal portion of shaft 3 within exchange member 2
`preferably extends at least about 25% of the length of
`exchange member 2, more preferably about 50 to 100%
`of the length of exchange member 2. It is within the
`scope of the invention that shaft 3 may extend distally of
`exchange member 2 and have, preferably, a flexible
`and/or otherwise atraumatic tip (not shown).
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`Shaft 3 may optionally, as shown in FIG. 4, be affixed
`to the outer surface 8 of exchange member 2,
`in the
`same manner as discussed for affixation to interior sur—
`face 7. It is also within the scope of this invention that
`shaft 3 could reside within the wall of exchange mem-
`ber 2.
`As shown in FIG. 5, exchange member 2 may have a
`longitudinal slit 10 of sufficient width to enable the
`exchange member 2 to “snap” over a PTCA catheter,
`guidewire or other device. Preferably the width of slit
`10 would be from about 1 to 5 mm. Also, as shown in
`FIG. 6, exchange member 2 may be discontinuous to
`the extent that wall members 11, 12 overlap to provide
`an opening of the same function as slit 10.
`In a typical application of the invention described
`above, a PTCA catheter is in position across or adjacent
`to a stenosis. The exchange member 2 is positioned over
`the proximal end of the PTCA catheter outside the
`body, and the exchange member 2 is advanced over the
`PTCA catheter shaft to the stenosis. Then, the PTCA
`catheter is withdrawn, leaving the exchange member 2
`across the stenosis, where it can function as a temporary
`stent to permit perfusion while additional therapy, for
`example, PTCA, atherectomy, insertion of a permanent
`stent, CABG, or the like, is planned. Optionally such an
`exchange can be done after the catheter/manifold hub
`of the PTCA catheter has been removed.
`A secondary device, for example, a second PTCA
`catheter, is advanced adjacent to shaft 3, to the lesion.
`Then, the shaft 3 is moved proximally to cause ex-
`change member 2 to move proximally, either adjacent
`to the target site or entirely from the body.
`Rigid shaft 1 may be a conventional guidewire, pref-
`erably a spring guidewire, as is well known. Typical
`guidewires are shown in US. Pat. Nos. 4,757,827,
`4,815,478, 4,813,434, 4,619,274, 4,554,929, 4,545,390,
`4,538,622, 3,906,938, 3,973,556, and 4,719,924, all of
`which are incorporated herein by reference. In addi-
`tion, shaft 3 could be solid or hollow, such as a hypo-
`tube, with an open distal end, to facilitate drug infusion.
`The proximal end of the shaft would then preferably
`have a Luer hub.
`The shaft and exchange member of the invention may
`each optionally have a lubricous coating or covering,
`such as any of the known polysiloxane or TEFLON ®
`materials. Also, either, or both, of the shaft and ex-
`change member could be made of lubricous material.
`The exchange member is, in general, made of medi-
`cally acceptable metal, for example, stainless steel, or
`rigid polymer, such as a polyester selected from the
`group consisting of polyurethanes, polyethylenetereph-
`thalate, polyethyleneterephthalate glycol, and copoly-
`mers thereof, an olefin such as polyethylene or a co-
`polymer thereof, polyvinylchloride, or the like. The
`exchange member could also be component of a mate-
`rial having properties (e.g., shape, size, or flexibility),
`that change due to hydration, temperature, or another
`factor. For example, a shape memory alloy such as
`Nitinol may be used.
`It is within the scope of the invention that the ex-
`change member may be detachable from the shaft, to
`leave the exchange member permanently in place. Such
`detachability could either be immediate or “on de-
`mand”, where the shaft and exchange member would be
`joined in such a way, or with such a mechanism, that
`the operator could manipulate the proximal end of the
`shaft to cause the shaft and exchange member to sepa-
`rate. In the alternative, the shaft and exchange member
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`5
`may be affixed by appropriate glue, for example, whose
`adhesive properties would lessen with time, hydration,
`or temperature, such that after 24 to 48 hours the shaft
`could be detached and withdrawn. For example, the
`adhesive bonding properties of a hydrogel adhesive
`would diminish with hydration.
`In the embodiment of the invention shown in FIGS.
`7 and 8, the RECS 20 comprises a coil 21, preferably a
`radiopaque coil, and a rigid shaft or pushing wire 22.
`Positioned eccentrically or concentrically, preferably
`eccentrically, around shaft 22 is a flexible, collapsible
`sheath 23, shown collapsed in FIG. 7 and expanded in
`FIG. 8. At the proximal end of sheath 23 is a hemostatic
`manifold 24, including a valved infusion port 25 in fluid
`communication with the interior of sheath 23.
`In the alternate embodiment shown in cross-section
`in FIGS. 9 and 10, sheath 32 is bonded or formed with
`shaft 30, which defines lumen 31. Pushing wire 33 ex-
`tends longitudinally within lumen 31.
`Sheath 23 or 32 extends distally to at least the distal
`end of pushing wire 22 or 33. Where exchange member
`21 is instead a cylindrical tubular member, such as ex-
`change member 2, the sheath 23 or 32 can extend into
`and/or through said exchange member.
`Sheath 23 or 32 facilitates the passage of a second
`PTCA catheter, guidewire, or other exchangeable de-
`vice after the first device is removed, and provides for
`atraumatic passage of these other devices since the
`sheath 23 or 32 prevents contact of the catheter or other
`device with the lining of the artery. Also, the sheath can
`provide a means for subselective cathetcrization for
`purposes such as (1) active perfusion of blood or oxy-
`gen-bearing fluid; (2) distal/selective dye injection; or
`(3) selective infusion of medications directly to the le-
`sion site.
`The flexible sheath 23 or 32 is preferably bonded by
`suitable means, such as heat-shrinking or adhesive, to
`the pushing wire 22 or 33, respectively, either continu—
`ously or at discrete points longitudinally along the push-
`ing wire 22 or 33. The proximal end of the sheath 23 or
`32 is bonded by suitable means, such as heat-shrinking
`or adhesive, to a manifold or hub, and the pushing wire
`22 or 33 may terminate at the manifold or hub or extend
`proximally therethrough. Flexible sheath 23 or 32 and-
`/or shaft 30 may each be single or multiple, such as
`double or triple, lumen.
`The preceding specific embodiments are illustrative
`of the practice of the invention. It is to be understood,
`however, that other expedients known to those skilled
`in the art or disclosed herein, may be employed without
`departing from the spirit of the invention or the scope of
`the appended claims.
`I claim:
`1. A method of exchanging exchangeable members in
`a corporal channel, which comprises the steps of:
`(a) advancing into a patient’s body a first exchange-
`able member having proximal and distal portions
`through a corporal channel so that the distal por-
`tion of said first exchangeable member is at a de-
`sired site;
`(b) placing an exchange member of a rapid exchange
`catheter system comprising:
`(1) an exchange member having proximal and distal
`ends, and
`(2) a rigid pushing wire having proximal and distal
`ends, the distal end of the pushing wire being
`integral with the proximal end of the exchange
`member, such that said pushing wire is config—
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`ured to advance the exchange member distally to
`a desired location wherein the exchange member
`is positioned concentrically to an exchangeable
`member,
`over the proximal portion of said first exchangeable
`member and advancing said rapid exchange cathe-
`ter system distally so that the distal portion of the
`exchange member is adjacent to or at the distal
`portion of the first exchangeable member;
`(c) withdrawing said first exchangeable member
`proximally through said exchange member and
`removing said first exchangeable member from the
`body;
`(d) advancing a second exchangeable member distally
`through said corporal channel through said ex-
`change member to the desired site; and
`(e) withdrawing said exchange member through said
`corporal channel to remove the rapid exchange
`catheter system from the body.
`2. The method of claim 1, wherein steps (c) and (d)
`are repeated at least one time.
`3. The method of claim 1, wherein each exchangeable
`member is selected of the group consisting of catheters,
`balloon dilatation catheters, guidewires, stents, perfu-
`sion catheters,
`infusion catheters, and atherectomy
`catheters.
`4. A method of exchanging exchangeable members in
`a corporal channel, which comprises the steps of:
`(a) advancing into a patient’s body a first exchange-
`able member having proximal and distal portions
`through a corporal channel so that the distal por-
`tion of said first exchangeable member is at a de-
`sired site;
`(b) placing an exchange member of a rapid exchange
`catheter system comprising:
`(1) an exchange member having proximal and distal
`ends, and
`(2) a rigid pushing wire having proximal and distal
`ends, the distal end of the pushing wire being
`integral with the proximal end of the exchange
`member, such that said pushing wire is config-
`ured to advance the exchange member distally to
`a desired location wherein the exchange member
`is positioned concentrically to an exchangeable
`member, and wherein the pushing wire has a
`flexible, collapsible sheath having proximal and
`distal ends and being arranged thereon, such that
`as the collapsible sheath is expanded by infusion
`of fluid or insertion of a catheter, guidewire, or
`other device,
`the diameter of the sheath in—
`creases, and when the fluid flow ceases or the
`catheter, guidewire, or other device is with-
`drawn, the diameter of the sheath decreases,
`over the proximal portion of said first exchangeable
`member and advancing said rapid exchange cathe-
`ter system distally so that the distal portion of the
`exchange member is adjacent to or at the distal
`portion of the first exchangeable member;
`(c) withdrawing said first exchangeable member
`proximally through said exchange member and
`removing said first exchangeable member from the
`body;
`(d) advancing a second exchangeable member distally
`through said corporal channel through said ex-
`change member to the desired site; and
`(e) withdrawing said exchange member through said
`corporal channel to remove the rapid exchange
`catheter system from the body.
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`5‘ The method 0f claim 4) wherein steps (C) and (d)
`are repeated at least one time.
`6. The method of claim 4, wherein the collapsible
`shaft inflates from fluid infusion or from insertion of said
`second exchangeable member.
`7. The method of claim 4, wherein each exchangeable
`
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`member is selected of the group consisting of catheters,
`balloon dilatation catheters
`uidewires stents perfu-
`, g
`.
`.
`.
`Slon catheters,
`inquIOn catheters, and atherectomy
`5 catheters.
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