United States Patent (19)
`Crittenden
`
`|||||||||||||||
`US005290247A
`(11) Patent Number:
`5,290,247
`(45) Date of Patent:
`Mar. 1, 1994
`
`(56)
`
`has an elongate tubular body with a proximally facing
`(54) INTRACORONARY EXCHANGE
`funnel at the proximal end of the sheath. A proximally
`APPARATUS AND METHOD
`extending wire for manipulating the sheath is attached
`(75) Inventor: James F. Crittenden, Hollis, N.H.
`to the proximal end of the sheath. The intracoronary
`sheath is advanced by manipulation of the wire over a
`73) Assignee: C. R. Bard, Inc., Murray Hill, N.J.
`first catheter positioned in a guide catheter and extends
`21 Appl. No.: 703,603
`beyond the distal end of the guide catheter into the
`patient's vascular system. After the first catheter is re
`(22
`Filed:
`May 21, 1991
`moved, a second catheter advanced through a guide
`51) int. Cl'............................................... A61M 5/00
`catheter is guided by the funnel into the intracoronary
`(52)
`604/171; 604/96
`sheath and through the vascular system to a desired
`58) Field of Search ................. 604/171, 164, 170, 96,
`position in the patient's body. A second embodiment
`604/264, 280, 158, 159, 102
`provides for the exchange of a second guidewire for a
`References Cited
`first guidewire. A first guidewire is positioned within a
`monorail-type catheter extending into the patient's vas
`U.S. PATENT DOCUMENTS
`cular system. The monorail type catheter is provided
`4,431,426 2/1984 Groshong et al............... 604/164 X
`4,606,347 8/1986 Fogarty et al. ................. 604/102 X with a proximally facing funnel on a proximally facing
`4,762,129 8/1988 Bonzel - - -
`-
`- -
`- -
`-
`- - - - -
`-
`- - - -
`-
`-
`-
`- - 604/96
`opening leading into the lumen of the monorail catheter
`:::::::: Singam 3.
`which receives the guidewire. After the first guidewire
`5,041,085 8/1991 Osborne et al. ................ 7x is removed, the second guidewire introduced. The fun
`5,147,335 9/1992 Wright ............................ 604/264 x nel guides the guidewire into the proximally facing
`opening and then into the guidewire lumen of the mono
`Primary Examiner-Gene Mancene
`rail-type catheter.
`Assistant Examiner-Jeffrey A. Smith
`Attorney, Agent, or Firm-Morgan & Finnegan
`(57)
`ABSTRACT
`An intracoronary sheath for use in catheter exchanges
`
`28 Claims, 7 Drawing Sheets
`
`
`
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`Page 1
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`

`

`U.S. Patent
`
`Mar. 1, 1994
`
`Sheet 1 of 7
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`5,290,247
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`Page 2
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`

`

`U.S. Patent
`
`Mar. 1, 1994
`
`sheet 2 of 7
`
`5,290,247
`
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`Page 3
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`

`U.S. Patent
`
`Mar. 1, 1994
`
`Sheet 3 of 7
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`5,290,247
`
`?tra 22-236
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`1.
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`Page 4
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`U.S. Patent
`
`Mar. 1, 1994
`
`Sheet 4 of 7
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`5,290,247
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`Page 5
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`U.S. Patent
`
`Mar. 1, 1994
`
`Sheet 5 of 7
`
`5,290,247
`
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`Page 6
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`U.S. Patent
`
`Mar. 1, 1994
`
`Sheet 6 of 7
`
`5,290,247
`
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`Page 7
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`U.S. Patent
`
`Mar. 1, 1994
`
`Sheet 7 of 7
`
`5,290,247
`
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`O
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`Page 8
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`

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`1.
`
`NTRACORONARY EXCHANGEAPPARATUS
`AND METHOD
`
`O
`
`FIELD OF THE INVENTION
`This invention relates to improvements in catheter
`exchanges between one type of catheter, such as an
`over the wire percutaneous transluminal coronary angi
`oplasty (PTCA) catheter and a fixed wire catheter or
`between two fixed wire catheters without losing the
`ability to position the succeeding catheter quickly in the
`stenosis being treated. The invention also relates to
`guidewire exchanges, in which one guidewire may be
`substituted for another in a monorail type catheter with
`15
`out losing the position of the monorail catheter in the
`patient's body.
`BACKGROUND OF THE INVENTION
`This invention relates to improvements in devices
`20
`and techniques used with small diameter low profile
`dilatation angioplasty catheters, particularly in coro
`nary angioplasty. More particularly, the invention con
`cerns improvements in systems for effecting catheter
`exchanges when one of the catheters is of the "fixed
`wire' type which incorporates a wire-like shaft that is
`sufficiently torsionally rigid so as to be steerable
`thereby enabling the catheter to be selectively guided
`and steered to the desired location in the patient's coro
`nary arteries.
`In performing coronary angioplasty, it often occurs
`30
`that the physician may wish to use a catheter different
`than the one originally inserted into the patient. For
`example, this may occur if the initial selection of cathe
`ter balloon size was inappropriate to treat the patient's
`stenosis or some other event occurs that would make
`35
`use of a different catheter desirable. When the catheter
`is of the type that uses a separate movable guidewire,
`the catheter may be exchanged in a well known proce
`dure in which an exchange wire is substituted for the
`movable guidewire (or the length of the guidewire is
`extended with an extension wire); then the catheter is
`withdrawn over the exchange wire and the replacement
`catheter is threaded over the exchange wire and is
`thereby guided to the stenosis. By maintaining the
`guidewire in position during the exchange procedure,
`45
`the replacement catheter is easily and quickly advanced
`to the stenosis.
`The foregoing catheter exchange procedure has not
`been usable with small diameter low profile dilatation
`catheters of the type that incorporate an integral guide
`wire because the balloon catheter cannot be separated
`from the guidewire. Thus, when it is desired to ex
`change one such dilatation catheter for another, the
`typical procedure is to withdraw the entire catheter and
`integral guidewire and then replace it with the desired
`catheter. Withdrawal of the catheter, however, results
`in loss of position of the catheter in the stenosis. As a
`result, the next placed catheter must be re-manipulated
`through the patient's arterial system to position the
`balloon in the stenosis. The replacement of the catheter
`typically involves time consuming manipulation and
`steering to guide the catheter to place its balloon within
`the stenosis. The additional procedure increases some
`what the risk of trauma to the patient.
`A similar problem is presented when it is desired to
`exchange a conventional movable guidewire dilatation
`catheter for a catheter of the type having an integral
`guidewire. Again, in order to make such an exchange, it
`
`5,290,247
`2
`has been customary to remove completely the movable
`guidewire and the dilatation catheter to permit insertion
`of the integral guidewire type of catheter. Because there
`is nothing to guide the catheter directly to the stenosis,
`it is necessary for the physician to go through all the
`manipulations necessary to steer and guide the new
`catheter to the stenosis.
`A problem again occurs in the use of a monorail type
`catheter. It may be desired to exchange the indwelling
`guidewire with another guidewire of a different size or
`stiffness. Presently, if the guidewire is removed with the
`monorail catheter, the replacement guidewire must be
`remanipulated back through the patient's arterial sys
`tem, a time consuming task. If the monorail catheter is
`left in place and only the guidewire removed, it is not
`possible to re-manipulate and steer the replacement
`guidewire to the opening or entry port of the lumen of
`the monorail which accepts the guidewire because the
`entry port or opening is of small diameter and of unsuit
`able orientation.
`It would be desirable, therefore, to provide a system
`by which guidewire exchange may be facilitated with
`the use of a monorail-type catheter.
`It would be desirable, therefore, to provide a system
`by which catheter exchanges involving small diameter
`low profile dilatation catheters having an integral
`guidewire could be effected easily, quickly, without loss
`of position and with minimal trauma. It is among the
`objects of the invention to provide such a system.
`SUMMARY OF THE INVENTION
`The intracoronary sheath of the present invention is
`used with a small diameter coronary dilatation catheter
`having a shaft formed from stainless steel hypodermic
`tubing. The distal end of the shaft is of increasing flexi
`bility and terminates in a highly flexible distal tip. A
`dilatation balloon is mounted to the shaft near the distal
`end. The interior of the balloon is in communication
`with the lumen extending through the hollow shaft. The
`balloon may be inflated and deflated with a liquid by a
`syringe or other suitable inflation device attached to the
`proximal end of the shaft by a luer fitting carried at the
`proximal end of the shaft. The luer fitting is detachable
`from the hypodermic tubing so as to present a smooth
`continuous diameter at the proximal end of the catheter
`shaft. The luer fitting includes a collet and nut arrange
`ment by which the luer fitting can grip securely the
`tubular proximal end of the dilatation shaft.
`In order to introduce the intracoronary sheath of the
`present invention over the dilatation catheter, the luer
`fitting must first be detached from the catheter. After
`the luer fitting is detached, the intracoronary sheath of
`the present invention is placed over the catheter shaft
`and advanced through the guide catheter. The guide
`catheter will have been already previously positioned
`such that it leads to the entrance to the coronary artery.
`The intracoronary sheath is attached to a relatively stiff
`wire-like shaft that is attached to and extends proxi
`mally of the proximal end of the intracoronary sheath.
`A flexible funnel attached at the proximal end of the
`intracoronary sheath is made of a material capable of
`collapsing or folding such that it easily passes through
`the Y-connector of the guide catheter. By advancing
`the wire-like shaft, the distal end of the intracoronary
`sheath is moved out of the guide catheter and into the
`coronary artery itself until it reaches a desired location
`at the stenosis near the tip of the fixed wire catheter.
`
`25
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`55
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`65
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`

`

`5,290,247
`4.
`3
`FIG. 4B is a diagrammatic illustration of an alterna
`The fixed wire catheter then may be withdrawn
`through the intracoronary exchange sheath, through
`tive embodiment of the intracoronary sheath of FIG.
`the guide catheter and out of the patient. A replacement
`. 4A.
`FIG. 5 is a fragmented illustration of a coronary
`guidewire or catheter may next be introduced through
`arterial system with a guide catheter in place and a
`the guide catheter, until it reaches the funnel. The fun
`dilatation catheter having a detachable luer fitting ex
`nel guides the replacement guidewire or catheter into
`tending through the guide catheter and into the stenosis
`the intracoronary sheath which, in turn, guides the
`of a coronary artery;
`catheter or guide wire. The sheath is dimensioned in
`FIG. 6 is an illustration similar to FIG. 5 with the
`length such that even in its most extended position, the
`proximal luer fitting of the catheter detached, and the
`O
`proximal end of the sheath is positioned proximal of the
`exchange sheath advanced over the balloon dilatation
`aortic arch. The intracoronary sheath may then be re
`catheter and into the coronary artery in proximity to
`moved by pulling it over the replacement device by the
`the stenosis; and
`wire-like shaft, thus leaving the replacement device in
`FIG. 7 is an illustration of the arterial and catheter
`the desired location within the body. The funnel may be
`system of FIG. 6 with the dilatation catheter removed,
`15
`perforated to allow the infusion of contrast fluids
`leaving the exchange sheath in place and in readiness to
`through the guide catheter, or to allow pressure moni
`receive another dilatation catheter having an integral
`toring of the patient.
`guidewire.
`The guiding capability provided by the funnel ap
`FIGS. 8A and 8B are partial sectional illustrations of
`plied to the intracoronary sheath may be suitably
`a portion of the guide catheter and showing the guiding
`20
`adapted for use with a monorail-type catheter. Typi
`of a new catheter into the sheath after it has been posi
`cally, a monorail-type catheter is contained within a
`tioned within the guide catheter.
`guide catheter which is in turn positioned in the patient.
`FIGS. 9A and 9B illustrate an alternative embodi
`This capability is accomplished by providing a proxi
`ment of the funnel associated with the exchange sheath.
`mally-facing funnel in the vicinity of and around the
`FIG. 10 is an illustration of a monorail-type catheter.
`25
`periphery of the monorail-type catheter's entry port or
`FIG. 11 is an enlarged partial sectional illustration of
`opening provided for receiving a guidewire. The guide
`the catheter of FIG. 10 modified with the funnel of the
`wire to be exchanged is removed by withdrawing it out
`present invention.
`of the guide catheter, while maintaining the monorail
`FIG. 12 is a cross sectional illustration of the opening
`type catheter in place. Then, the replacement guidewire
`into the lumen of the catheter as seen along the line
`30
`is manipulated through the guide catheter in a direction
`12-12 of FIG. 11.
`towards the entry port or opening of the monorail cath
`eter. Upon reaching the proximally facing funnel, the
`guidewire will be guided into the entry port or opening
`and subsequently into the guidewire lumen in the mono
`35
`rail-type catheter. As in the intracoronary sheath en
`bodiment, the funnel may be perforated to allow the
`infusion of contrast fluids through the guide catheter.
`It is among the general objects of the invention to
`provide an improved system for performing catheter
`exchanges involving a small diameter dilatation cathe
`ter having an integral guidewire.
`Another object is to provide a movable sheath which
`is advanced and positioned within the guide catheter to
`45
`facilitate catheter exchanges without losing the cathe
`ter's position within the body.
`Yet another object is to provide a guide on a monorail
`catheter which facilitates guidewire exchanges without
`disturbing the position of the catheter.
`DESCRIPTION OF THE DRAWINGS
`The foregoing and other objects and advantages of
`the invention will be appreciated more fully from the
`following further description thereof with reference to
`55
`the accompanying drawings wherein:
`FIG. 1 is a fragmented illustration of a small diame
`ter dilatation catheter having an integral guidewire-like
`shaft:
`FIG. 2 is an enlarged cross sectional illustration of the
`proximal end of the dilatation catheter shaft and the luer
`fitting;
`FIG. 3 is an exploded illustration of the luer fitting;
`FIG. 4A is a diagrammatic illustration of an in
`tracoronary sheath in accordance with the invention
`65
`having its proximal end positioned within the guide
`catheter and its distal end extending distally toward the
`coronary artery, in readiness to receive and guide a
`newly-introduced catheter.
`
`DESCRIPTION OF THE ILLUSTRATIVE
`EMBODIMENTS
`FIG. 1 illustrates, generally, a fixed-wire type of
`small diameter balloon dilatation catheter 10 with
`which the present invention is particularly useful. The
`catheter may be of the order of 175 cm long. It includes
`an elongate shaft 12 formed from hypodermic tubing. A
`polymeric dilatation balloon 14 is mounted to the distal
`end of the catheter. The distal tip 16 of the catheter is of
`increasing flexibility in a distal direction and, typically,
`may include a helical coil of radiopaque material. The
`shaft 12 is sufficiently torsionally rigid so that it may
`transmit rotation from the proximal to the distal end of
`the catheter when the distal end is in the coronary arter
`ies. In order that the device may be selectively steered
`through the branches of the coronary anatomy, the
`distal tip 16 is adapted to be bent to a slight "J" shape
`illustrated in phantom at 17. Aluer fitting 18 is attached
`to the proximal end of the shaft 12 to enable attachment
`of an inflation device such as a syringe (not shown) to
`inflate and deflate the balloon 14 with a suitable fluid,
`such as radiopaque contrast liquid. Such a catheter is
`disclosed in more detail in U.S. Pat. No. 4,917,088 is
`sued Apr. 17, 1990.
`As shown in FIGS. 2 and 3, the luer fitting, indicated
`generally at 18, includes a hub 20 having a socket 22 at
`its proximal end and a distally tapering bore 24 located
`distally of the socket 22. An aperture 26 is formed at the
`distal end of the hub 20 and receives the proximal end of
`the catheter shaft 12. A collet 28 having distally extend
`ing fingers 30 is provided with a central bore 32, also to
`receive the proximal end of the shaft 12 of the catheter.
`A compressible gasket 34 formed from an elastomeric
`material such as silicone rubber, and also provided with
`a central bore 36, abuts the proximal face of the collet
`28. The bore 36 of the gasket 34 receives the proximal
`
`50
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`sheath. The wire 114 preferably may be made of stain
`end of the catheter shaft 12. A shaft stop member 38 is
`provided with a central aperture 40 which tapers in a
`less steel and preferably 0.020 inch in diameter. The
`sheath 102 preferably has an outside diameter of 0.060
`proximal direction. The bore 40 tapers to a diameter
`in. and 0.050 inch inside diameter and may be con
`that is smaller than the diameter of the proximal end of
`structed of high density polyethelene. The funnel 104
`the catheter shaft 12 and, therefore, serves as an abut
`may be constructed of the same material and heat
`ment for the proximal end of the shaft 12 as shown in
`FIG. 2, to prevent it from extending proximally beyond
`bonded to the sheath. As shown in FIG. 9A, the wire
`114 may be attached to sheath 102 through a hole or
`the stop member 38. The collet 28, gasket 34 and stop
`perforation 128 in the cone 104. The wire may be ta
`member 38 are securely retained between the hub 20
`pered down at the point of its attachment to sheath 102
`and a luer body 42 having a threaded distal end 44 that
`and may be wrapped around sleeve 102 to secure it to
`screws into the socket 22 of the hub 2.0. The distal end
`the sleeve by suitable bonding. The portion of wire 114
`of the luer body 42 has a socket 46 which receives stop
`wrapped around sheath 102 may be radiopaque coated
`member 38, the gasket 34 and the proximal portion of
`to act as a fluoroscopic marker in lieu of or in conjunc
`the collet 28. The distal fingers 30 of the collet bear
`tion with a radiopaque marker band 126. The funnel's
`against the tapered bore 24 in the nut. When the luer
`narrow opening 106 is mounted to the proximal end of
`body 42 is screwed into the nut 20, the collet fingers 30
`the sheath 102 and the larger opening 109 of funnel 104
`constrict about the proximal end of the shaft 12 to se
`extends proximally of the narrow opening. The funnel
`curely lock the luer fitting 18 in place. The gasket 34
`104 is perforated with one or more holes or slots 108
`also is compressed to effect a secure liquid seal about
`which are sized such that fluids in passage 110 may pass
`the shaft 12. The proximal end of the luer body 42 has
`through perforations 108 to passage 112 in the guide
`aluer socket 48 adapted to be connected to a syringe or
`catheter 51. The perforations thus permit the passage of
`other inflation/deflation device. Thus, it will be appre
`fluids through the guide catheter 51 and into the per
`ciated that the entire luer fitting 18 may be detached
`son's body and permit monitoring of blood pressure in
`from the proximal end of the shaft 12 simply by un
`the person's body. The perforations 108 permit free
`screwing the hub 20 and uer body 42 to release the
`25
`passage of fluids through the funnel but are sized small
`collet and permit the assembly to slide off of the proxi
`enough (on the order of 0.008 inch in diameter for a
`mal end of the shaft 12.
`circular perforation and 0.008 by 0.020 inch for a slotted
`FIG. 5 illustrates a guide catheter 51 in place in the
`perforation) so a catheter cannot enter any of the perfo
`patient's arterial system and a small diameter dilatation
`catheter 10 extending through the guide catheter 51,
`rations 108. The number of perforations in the funnel
`30
`are preferably chosen such that the total area of the
`into a coronary artery 57 and into the stenosis 59. A
`perforations is at least equal to the cross-sectional area
`catheter exchange requires removal of the initial cathe
`of the guide catheter to assure free fluid flow through
`ter 10.
`the funnel. The outer diameter of the large opening 109
`In the mode of operation illustrated in FIG. 5, the
`luer fitting 18 is first detached from the catheter shaft by
`of funnel 104 is of a dimension such that it fits snugly
`35
`within the guide catheter 51 yet can be passed through
`unscrewing the luer body to loosen the fitting 18. Re
`the guide catheter 51 without excessive effort.
`moval of luer 18 leaves the catheter shaft 12 of FIG. 5
`available to act as a guide for the exchange sheath of the
`FIG. 4B illustrates an alternative embodiment of an
`intracoronary sheath. In FIG. 4B, sheath 152 is flared at
`present invention. The present invention illustrated in
`its proximal portion 150. The funnel 154 has an elon
`FIGS. 4A and 4B provides an intracoronary sheath 102
`gated distal extension portion 156 which extends from
`having proximal and distal ends. For purposes of the
`present discussion, it suffices that the sheath 102 is un
`the distal end 158 of the funnel 154 and is inserted into
`the flared proximal portion 150 of the sheath 152. In
`derstood as being used with a guide catheter in the
`manner shown by FIG. 5. Referring now to FIG. 4A,
`addition, a wire-like shaft 160, of similar construction
`the sheath 102 is a generally solid tubular member hav
`and material to wire-like shaft 114, at its distal end is
`45
`ing two open ends and is proportioned to be of a diame
`wound into a spiral section 162 and wrapped around the
`distal portion 156 of the funnel 154. The spiral section
`ter generally less than the diameter of a guide catheter
`162 may be incorporated into a heat bond formed be
`51. The sheath 102 may be constructed of lengths rang
`tween the proximal portion 150 of the sheath 152 and
`ing from about 15 cm. to, more advantageously, 35 cm.
`The latter length is more advantageous because, for an
`the distal extension portion 156 of the funnel 154. This
`average person, constructing the sheath of length 35
`provides a highly reliable, secure attachment of the wire
`160 to both the sheath 152 and funnel 154. In the em
`cm. assures that the sheath may extend, in its extreme
`bodiment of FIG. 4B, radiopaque marking can be ac
`extended position into the coronary artery as illustrated
`complished by plating the spiral section 162 with a
`in FIG. 6 and proximally back over the aortic arch as
`dense metal (e.g., gold) or alternatively a short spiral of
`also shown in FIG. 6. In this manner, the wire 114 will
`55
`extend proximally of the aortic arch as well, thus mak
`dense metal wire may be interfitted with the stainless
`ing unnecessary the bending of the relatively stiff wire
`steel wire 160 in bifilar fashion. In assembling the sheath
`152 with funnel 154 and spiral section 162, first heat
`114 around the aortic arch. However, it is not required
`shrink tubing (not shown) of known construction is
`that the sheath be so dimensioned since the funnel can
`used as a compression tool over the flared portion 150.
`approach to the distal end of the guide catheter and
`A mandrel wire (not shown) of known construction and
`function as desired.
`use is inserted into an opening 164 in the funnel and
`It is important that the sheath not be advanced so far
`supports the interior walls of the funnel 154. The wire
`that the sheath and its attached funnel pass out of the tip
`maintains a smooth inner diameter during the compres
`116 of the guide catheter 51. This event is prevented by
`sion heat bonding. After the bonding is completed, both
`sizing the wire 114 of a length, preferably less than 100
`65
`the mandrel wire and shrink tubing are removed, thus
`cm., so that its extension outside the body, when the
`leaving the flared portion of the sheath heat bonded to
`sheath is fully inserted in a manner shown in FIG. 6, is
`the funnel and spiral wire.
`minimal, thus preventing further advancement of the
`
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`5,290,247
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`8
`While in the preferred embodiment shown in FIG.
`In an alternative construction, the positions of the
`funnel and sheath just described in reference to FIG. 4B
`4A a funnel has been shown and described, any other
`suitably-shaped guide may be used. The funnel 104 may
`may be reversed. The funnel may be constructed of
`be more elongated with a higher length to diameter
`sufficiently large diameter to be fitted over the sheath.
`proportion. A funnel so constructed allows a greater
`In order to secure the spiral wire wrapped around the
`number of perforations in the funnel, further lessening
`funnel, a section of conventional heat shrink tubing
`resistance to fluid flow between passage 110 and pas
`would be fitted over the funnel and permanently at
`sage 112 of the sheath. Further, while a funnel with
`tached to the funnel to secure the funnel and spiral wire
`relatively uniformly inclined walls is shown in FIG. 4, it
`to the sheath. The spiral wire section 162 may be elimi
`may be formed in a suitable convex or concave shape.
`nated altogether and, as in FIG. 4A, the wire 160 may
`10
`In order to accommodate different diameter guide cath
`be straight tapered and bonded to the sheath with an
`eters, the funnel may be slit by one or more slits 130 cut
`adhesive such as methylcyanoacrylate or ultraviolet
`through the funnel body and extending along its length
`curing adhesive, such as Loctite Corporation's
`completely or partially from larger opening 109 to
`UV-350 product. While the funnels of FIGS. 4A and
`smaller opening 106, as shown in FIGS. 9A and 9B. As
`4B are shown as being generally centrally-disposed
`illustrated in FIG. 9A, when the cone 104 is in a guide
`within a guide catheter, the funnels may be offset from
`catheter whose diameter approximates that of the outer
`their central position and constructed in a manner simi
`funnel diameter 109, there is no overlapping of the fun
`lar to that to be described below in reference to FIG. 11
`nel portions over slit 130. When, however, the guide
`of the present invention. While the funnel of FIG. 11 is
`catheter diameter is smaller than the diameter 109 of the
`attached to a monorail-type catheter, the funnel in this
`outer funnel, then the slit will permit the funnel ends to
`alternative embodiment would be attached to a sheath
`overlap, as shown in FIG.9B. The funnel may be injec
`similar to the sheath 102 of FIG. 4A or sheath 152 of
`tion molded for resulting uniform wall thickness. Al
`FIG. 4B.
`though the funnel and the sheath may be made of one
`In order to advance the intracoronary sheath 102
`piece construction, preferably the two pieces are sepa
`25
`through the guide catheter 51 and to position it within
`rately constructed and heat bonded together. The radi
`the guide catheter, a wire-like shaft 114 is attached
`opaque marker or band 126 may be incorporated in the
`towards the proximal end of the sheath 102, as shown in
`heat bond between the sheath and funnel. The funnel
`FIG. 4A distally of the funnel 104. The wire-like shaft is
`may be constructed without holes or perforations. In
`sufficiently long to extend proximally through the guide
`such construction, a contrast or other fluid may be
`catheter to the outside of the body so that the sheath
`directed, from the guide catheter by the solid funnel
`may be advanced and positioned by manipulation of the
`through the sheath 102 and directly to a body lumen at
`proximal end of the wire 114 yet short enough, as de
`or adjacent to the distal end 118 of sheath 102. Further,
`scribed above, such that when the sheath is fully in
`to assist in the positioning of the sheath 102, both at its
`serted as shown in FIG. 6, the length of wire 114 out
`distal end and in the region of its proximal end, radi
`35
`side the body is minimal to prevent further advance
`opaque bands may be utilized respectively on the distal
`ment of the sheath 102.
`tip 118 and on the proximal end of sheath 102, shown
`In operation, when it is desired to perform a catheter
`respectively as bands 124 and 126.
`exchange, the luer 18 is disconnected as described. At
`FIGS. 10, 11 and 12 show the invention of the present
`this point the catheter (see catheter 10 in FIG. 5) re
`application applied to rapid exchange two lumen mono
`mains in place. The operator then threads the distal end
`rail catheters of a type disclosed in Ser. No. 618,531,
`of the sheath 102 onto the proximal end of the catheter
`filed Nov. 26, 1991, now abandoned, for a "Rapidly
`10 and advances it along the length of the catheter in a
`Exchangeable Coronary Catheter', assigned to the
`monorail fashion. Once the length of the sheath and
`assignee of the present application, the disclosure of
`funnel are within the proximal end of the guide catheter
`which is incorporated herein by reference. As shown in
`45
`51, the wire 114 is gripped and pushed, thus advancing
`FIG. 10, a guidewire 132 is shown inserted into the
`the sheath through the distal tip 116 of the guide cathe
`distal portion 134 of a catheter 133 which also has a
`ter 51. When the advancing is completed, the tip 118 of
`proximal portion 136. In this monorail-type catheter, as
`the sheath should be positioned in the desired location,
`shown in FIG. 10, the guidewire lumen 140 extends
`for example, in the area of the stenosis 59 as shown in
`only over a relatively short length of the catheter at the
`F.G. 6.
`distal end of the catheter. Because the guidewire lumen
`After the positioning, the catheter 10, which may be
`140 is shorter than the portion of the guidewire that
`a fixed wire or other catheter, may be removed by
`protrudes out of the patient, as shown in FIG. 10, some
`withdrawing it in the conventional manner. This action
`part of the guidewire is always exposed and may be
`leaves the sheath in place and allows the operator to
`grasped to maintain guidewire position. An advantage
`advance another catheter of any suitable type through
`of the monorail system is that it is unnecessary to use
`the guide catheter 51 as shown in FIG. 7. As illustrated
`exchange wires or other devices to increase the effec
`in FIGS. 8A and 8B, upon reaching the larger funnel
`tive length of the guidewire in order to perform a cathe
`opening 109, the tip of the advancing catheter may be
`ter exchange. Thus, the monorail-type catheter facili
`centered within the guide catheter 51 and thus advance
`tates introduction of the catheter into the patient's body,
`directly into sheath 102. If not centered, the tip of the
`as well as exchange of one balloon catheter of this type
`advancing catheter will be guided by the inner inclined
`for another, differently sized, balloon catheter of the
`walls 120 of funnel 104 to the opening 122 at the proxi
`same type. However, if it is desired to exchange the
`mal end of sheath 102 and thence through the sheath
`guidewire for another guidewire of different stiffness or
`and to the desired position within the coronary artery.
`diameter, for example, it has been heretofore not possi
`After the new catheter has been positioned as desired,
`ble to do so without removing the catheter as well (and
`the sheath may be removed or remain in place to permit
`thus causing a loss of position of the catheter). Alterna
`further catheter exchanges.
`tively, the guidewire may be removed without remov