United States Patent
`Kontos
`
`[19]
`
`l|||||||l||||||||Illllllllllllll||l||lllllllllllllll||||||||l||||||l||l|||l
`U8005439445A
`
`[11] Patent Number:
`
`5,439,445
`
`[45] Date of Patent:
`
`Aug. 8, 1995
`
`SUPPORT CATHETER ASSEMBLY
`
`Inventor:
`
`Stavros B. Kontos, Woodcliff Lake,
`NJ.
`
`Assignee: Boston Scientific Corporation,
`Watertown, Mass.
`
`Appl. No.: 267,037
`
`Filed:
`
`Jun. 27, 1994
`
`Related US. Application Data
`Continuation of Ser. No. 925,864, Aug. 7, 1992, aban-
`doned.
`
`
`[541
`
`[751
`
`[731
`
`[211
`
`[221
`
`[631
`
`[51]
`[52]
`
`[53]
`
`[56]
`
`...... A61M 29/00
`Int. Cl.6
`US. Cl. ........................................ 604/96; 604/53;
`604/95; 606/194
`Field of Search ..................... 604/96, 95, 53, 280,
`604/281, 282, 283, 101-104; 606/191—194
`References Cited
`U.S. PATENT DOCUMENTS
`3,605,750 9/1971 Sheridan et a1.
`.
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`4,279,252 7/1981 Martin.
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`3/1985 Dotter.
`4,509,523 4/1985 Pevsner .
`4,581,017 4/1986 Sahota .
`4,616,652 10/1986 Simpson .
`4,762,129
`8/1988 Bonzel .
`4,820,271
`4/1989 Deutsch .
`.
`4,824,435 4/1989 Giesy et al.
`4,893,623
`1/1990 Rosenbluth .
`4,909,252 3/1990 Goldberger .
`4,947,864
`8/1990 Shockey et a1.
`4,976,691 12/1990 Sahota .
`4,983,167
`1/1991 Sahota .
`4,988,356 1/1991 Crittenden et a].
`5,000,734
`3/1991 Boussignac et a1.
`5,000,743
`3/1991 Patel.
`.
`5,002,531
`3/1991 Bonzel
`5,019,042 5/1991 Sahota .
`5,035,686 7/1991 Crittenden et al.
`5,040,548
`8/1991 Yock .
`5,061,273 10/1991 Yock .
`5,090,958 2/1992 Sahota.
`5,108,370 4/1992 Walinsky .
`5,131,407 7/1992 Ischinger et a1.
`
`.
`
`.
`
`.
`
`.
`
`.
`
`9/1992 Sahota .
`5,143,093
`5,147,377 9/1992 Sahota .
`(List continued on next page.)
`FOREIGN PATENT DOCUMENTS
`WO92/07606 5/1992
`.
`WO92/07610 5/1992 WIPO .
`
`OTHER PUBLICATIONS
`
`Matthew L. Carr, “The Use of the Guiding Catheter in
`Coronary Angioplasty: The Technique of Manipulating
`Catheters to . . . Tight Coronary Stenoses,” Catheteriza—
`tion and Cardiovascular Diagnosis, 12:189—197 (1986).
`J. F. Reidy et a1., “Transcatheter Occlusion of Coro-
`nary to Bronchial Anastomosis by Detachable Balloon
`Combined with Coronary Angioplasty at Same Proce-
`dure,” Br. H_eart J., 49:284-7, 1983.
`Little, “Probe Angioplasty of Total Coronary Occlu-
`sion Using an Intracoronary Probing Catheter TM ”,
`Catheterization
`and
`Cardiovascular
`Diagnosis,
`17:218-223 (1989).
`
`Primary Examiner—John D. Yasko
`Attorney, Agent, or Firm—Fish & Richardson
`[57]
`ABSTRACT
`A support catheter assembly for facilitating medical
`procedures includes a tubular body and a continuous
`lumen from its proximal end to its distal end. A manipu-
`lating member is connected to the tubular body for
`inserting, advancing, withdrawing and maneuvering the
`body during a medical procedure. The manipulating
`member may be a wire or a manipulating tube. The
`tubular body also may be provided with a funnel shaped
`lumen opening at its proximal end to facilitate insertion
`of devices therethrough, and radiopaque markers for
`subcutaneously detecting the location of the device
`during a medical procedure and, more particularly, for
`detecting its location relative to other devices used in
`the medical procedure. A methOd also is disclosed for
`using the tube assembly to facilitate insertion of a
`PTCA catheter into a stenotic region and for holding
`open the lumen through that region after angioplasty
`has been performed,
`
`33 Claims, 6 Drawing Sheets
`
`
`
`Page 1
`
`Medtronic Exhibit 1409
`
`Page 1
`
`Medtronic Exhibit 1409
`
`

`

`5,439,445
`
`Page 2
`
`US. PATENT DOCUMENTS-
`Sahota .
`Crittenden et al.
`Shtunnan .
`Dubrul et al.
`Jones et a1.
`.
`Wall .
`
`5,160,321
`5,163,903
`5,181,911
`5,183,464
`5,190,058
`5,192,307
`
`1 1/1992
`1 1/1992
`1/1993
`2/1993
`3/1993
`3/1993
`
`.
`
`.
`
`5,226,888
`5,234,407
`5,255,690
`5,263,932
`5,267,958
`5,290,247
`5,299,575
`5,342,297
`
`7/1993
`8/1993
`10/1993
`1 [/1993
`12/1993
`3/1994
`4/1994
`8/1994
`
`.
`
`Army .
`Teirstein et a].
`Keith et a].
`Jang .
`Buchbinder et a1.
`Crittenden .
`Sandridge .
`Jang .
`
`.
`
`Page 2
`
`Medtronic Exhibit 1409
`
`Page 2
`
`Medtronic Exhibit 1409
`
`

`

`US. Patent
`
`Aug. 8, 1995
`
`Sheet 1 of 6
`
`5,439,445
`
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`
`Page 3
`
`Medtronic Exhibit 1409
`
`Page 3
`
`Medtronic Exhibit 1409
`
`

`

`US. Patent
`
`Aug. 8, 1995
`
`Sheet 2 of 6
`
`5,439,445
`
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`Page 4
`
`Medtronic Exhibit 1409
`
`Page 4
`
`Medtronic Exhibit 1409
`
`
`

`

`US. Patent
`
`Aug. 8, 1995
`
`Sheet 3 of 6
`
`5,439,445
`
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`Page 5
`
`Medtronic Exhibit 1409
`
`Page 5
`
`Medtronic Exhibit 1409
`
`
`

`

`US. Patent
`
`Aug. 8, 1995
`
`Sheet 4 of 6
`
`5,439,445
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`Page 6
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`Medtronic Exhibit 1409
`
`Page 6
`
`Medtronic Exhibit 1409
`
`
`

`

`US. Patent
`
`Aug. 8, 1995
`
`Sheet 5 of 6
`
`5,439,445
`
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`Page 7
`
`Medtronic Exhibit 1409
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`Page 7
`
`Medtronic Exhibit 1409
`
`
`

`

`US. Patent
`
`Aug. 8, 1995
`
`Sheet 6 of 6
`
`5,439,445
`
`
`
`FIGURE 14
`
`Page 8
`
`Medtronic Exhibit 1409
`
`Page 8
`
`Medtronic Exhibit 1409
`
`

`

`1
`
`SUPPORT CATHETER ASSEMBLY
`
`5,439,445
`
`- This is a continuation of application Ser. No.
`07/925,864, filed Aug. 7, 1992, now abandoned.
`BACKGROUND OF THE INVENTION
`1. Field of the Invention
`The present invention relates generally to a medical
`device and procedures for employing the device. More
`particularly, it relates to a support catheter assembly
`with particular utility in facilitating insertion of a PTCA
`balloon into a lesion. The present invention also has
`utility as a stent, for maintaining a continuous passage,
`e.g., through an area of an artery or vein which is other—
`wise susceptible to collapsing or restenosing.
`2. Description of the Prior Art
`PTCA catheters and percutaneous medical proce-
`dures for angioplasty are well known. In such proce-
`dures, a flexible PTCA catheter generally is percutane-
`ously inserted into a blood vessel of a patient and guided
`through the patient’s vascular system to the location of
`a restriction. Insertion and manipulation of the PTCA
`catheter is frequently facilitated by use of a guide cathe-
`ter. However, often these guide catheters are not able to
`reach all the way to the restriction. Thus, the gap be-
`tween the distal end of the guide catheter and the ste-
`notic region to be opened must be traversed by the
`PTCA wtheter alone.
`As those skilled in the art know, the distal end of a
`PTCA catheter is made to be extremely soft and flexible
`so as to facilitate its passage through tortuosities and
`restrictions in the vascular system. This flexibility, how-
`ever, also makes the catheter readily susceptible to
`kinking and bending. The guide catheter is employed, at
`least in part, to restrict the radial deflection of the
`PTCA catheter and thereby prevent buckling and kink-
`mg.
`The guide catheter, however, can generally reach
`only to the coronary ostia, whereas the lesion to be
`opened is most commonly located in one of the coro—
`nary arteries leading from the ostia. Thus, the balloon
`catheter must negotiate the ostia, enter the coronary
`artery and pass through the coronary artery to the le-
`sion without the help of the guide catheter (see FIG.
`14). The instant invention may be used to facilitate the
`passage of the balloon catheter from the end of the
`guide catheter to the lesion.
`Support structures for advancing and guiding a
`PTCA balloon catheter are well known. As discussed
`above, a guide catheter provides an independent sup-
`port structure. Integral support structures also have
`been developed. For example, US. Pat. No. 4,762,129
`(Bonzel) describes a dilation catheter which includes a
`balloon capable of being enlarged by injecting a fluid
`through an aspiration tube that terminates in the bal-
`loon. The aspiration tube is arranged laterally offset
`from a segment of flexible tube that forms a passage
`through the balloon for a guide wire. The aspiration
`tube, which is reinforced with a stabilizing wire, also
`serves to transmit thrust and tension forces to push and
`pull the balloon to and fro and rotate it on the guide
`Wire.
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`Coronary arterial stenoses generally are caused by
`the accumulation of plaque on the artery wall. Angio-
`plasty reduces the arterial restriction by expanding a
`balloon within the stenotic region and compressing the
`plaque against the vessel wall, thereby increasing the
`
`65
`
`2
`size of the lumen in that region. However, the plaque
`has a tendency to return to its original form and again
`close down or severely restrict the arterial lumen. This
`restenosing, if it occurs, may occur as quickly as within
`only a few minutes, although it may not occur for a few
`weeks, or even for several months. The tendency for
`restenosis is of particular concern where angioplasty is
`performed preparatory to surgery, when it is imperative
`that the passage through the artery be kept open, at least
`until the surgeon has had an opportunity to operate.
`SUMMARY OF THE INVENTION
`
`The present invention provides a support catheter,
`which can also function as a stent, connected to means
`such as a wire handle, to facilitate its insertion and ma-
`nipulation. By use of such manipulating means, the
`support catheter can be inserted into and passed
`through a guide catheter, over a PTCA catheter, and
`, out the distal end of the guide catheter so as to function
`as an extension of the guide catheter to bridge the gap
`(or at least some of it) between the end of the guide
`catheter and the stenosis to be opened. The present
`invention permits a physician to deliver, with greatly
`reduced risk of bending or kinking, a PTCA catheter to
`a site of coronary vessel restriction. It also facilitates the
`exchange of one catheter for a larger or smaller one. In
`addition, it provides a structure which can be inserted,
`after angioplasty, into a newly opened area of the lesion,
`thereby to prevent restenosis. Also, the support catheter
`of the instant invention can be made small enough to
`enter the coronary artery, something the guide catheter
`could not do.
`In one embodiment of the present invention, the ma-
`nipulating means is a wire attached to the proximal end
`of the support catheter.
`In another embodiment of the present invention, the
`manipulating means is an extension tube. The extension
`tube is attached to the proximal end of the support
`catheter, and is provided with a longitudinally extend-
`ing slit, e.g., for passing therethrough a guide wire or
`PTCA catheter tube. This structure provides direct
`access to the support catheter assembly at the proximal
`end of a guide catheter for fast insertion, withdrawal, or
`exchange of various balloon catheters.
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`These and other features and advantages of the pres-
`ent invention readily will be apparent from the follow-
`ing detailed description read in conjunction with the
`accompanying drawings, wherein:
`FIG. 1 is a side plan view of a support catheter of the
`present invention, cut-away in part to show in longitu-
`dinal cross-section a tubular body having a soft tip and
`radiOpaque marker, and a manipulating wire.
`FIG. 2 is a cross-sectional view, taken along line 2—2
`of FIG. 1, of one embodiment of a tubular body of the
`present invention.
`-
`FIG. 3 is a cross-sectional view, taken along line 3—3
`of FIG. 1, illustrating a base portion of the tubular body
`of one embodiment of the present invention.
`FIG. 4 is a cross-sectional View, taken along line 4—4
`of FIG. 1, illustrating a funnel opening of the base por-
`tion of one embodiment of the present invention.
`FIG. 5 is a side schematic view of a support catheter
`of the present invention having a PTCA catheter dis-
`posed therein.
`FIGS. 6A to 6C are cross-sectional views showing
`schematically three stages in a process for guiding a
`
`Page 9
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`
`

`

`5,439,445
`
`3
`PTCA catheter to a coronary artery lesion employing a
`support catheter according to the present invention.
`FIG. 7 is a schematic cross-sectional view of a lesion
`area of a coronary artery having a support catheter of
`the present invention distally extended from a guide
`catheter for delivering a PTCA catheter to a restriction
`in the artery.
`FIGS. 8A to 8C are cross—sectional views showing
`schematically three stages in a process for guiding a
`PTCA catheter to a coronary artery lesion, for progres-
`sively opening two sequential restrictions in a coronary
`artery and for disposing a support catheter of the pres-
`ent invention in the opened lesion to inhibit restenosis
`after withdrawal of the PTCA catheter.
`FIG. 9 is a schematic cross-sectional view of a lesion
`area of a coronary artery having a support catheter of
`the present invention resident therein for delivering a
`PTCA catheter to a restriction within the artery.
`FIG. 10 is a side plan view of a second embodiment of
`a support catheter of the present invention, cut-away to
`show in longitudinal cross-section a tubular body hav-
`ing a soft tip and radiOpaque marker, and an extension
`tube having a longitudinal slit therein.
`FIG. 11 is a cross-sectional view, taken along line
`11—11 of FIG. 10, illustrating a portion of the tubular
`body of a second embodiment of the invention.
`FIG. 12 is a cross—sectional view, taken along line
`12—12 of FIG. 10, illustrating a longitudinal slit of the
`extension tube of a second embodiment of the invention.
`FIG. 13 is a cross-sectional view, taken along line
`13—43 ‘of FIG. 10, illustrating a funnel opening of the
`extension tube of a second embodiment of the invention.
`FIG. 14 is a schematic cross-sectional view of the
`aorta, the coronary ostia and two coronary arteries
`illustrating an angioplasty procedure employing a sup—
`port catheter of the instant invention.
`DETAILED DESCRIPTION OF THE
`PREFERRED EMBODIMENTS
`
`Referring now to the drawings, wherein like refer-
`ence numerals correspond to like or similar elements
`throughout, FIGS. 1 to 4 illustrate a support catheter
`assembly (hereinafter “support assembly”) 10 of the
`present invention.
`Support assembly 10 is composed of two major ele-
`ments, a body 12 and an insertion/manipulation wire 14.
`Body 12, which may be viewed as a mini guide catheter,
`includes a tube 16 having a base portion 18 at its proxi-
`mal end 20. Tube 16 has a continuous lumen 22 there-
`through from proximal end 20 to distal end 24. Body 12
`also may include a funnel portion 26 formed at proximal
`end 20, and a soft tip 28 disposed at distal end 24. Wire
`14 is attached to body 12 at base portion 18. Support
`assembly 10 also may include a distal marker band 30
`and a proximal marker band 32.
`As shown in FIGS. 1 to 4, tube 16 is generally cylin-
`drical. More specifically, as shown in FIGS. 1 and 2, at
`distal end 24, tube 16 and lumen 22 are cylindrical and
`coaxial.
`As best shown in FIGS. 1 and 3, at proximal end 20,
`the outer wall of tube 16 is enlarged on one side (bottom
`side in FIGS. 1, 3 and 4) to form base portion 18, and
`may beflared out at proximal end 20 to form funnel
`portion 26. However, lumen 22 generally is continuous
`throughout.
`It will be appreciated that the conical opening of
`lumen 22 at funnel portion 26 facilitates insertion of a
`PTCA catheter or the like therethrough.
`
`4
`Tube 16 may be composed of any pliable material
`suitable for percutaneous medical procedures, but pref—
`erably is composed of a molded plastic material, such as
`polyethylene.
`Referring again to FIG. 1, soft tip 28 generally is
`cylindrical in shape and extends coaxially from distal
`end 24 of tube 16. Soft tip 28 may be composed of any
`highly flexible material suitable for percutaneous medi—
`cal procedures, but preferably is composed of a soft
`plastic such as a copolymer of polyethylene and ethyl—
`vinylalcohol (EVA). It will be appreciated that a soft,
`flexible, pliable distal tip substantially reduces the risk
`of injury to a vessel wall, as well as of inadvertently
`dislodging portions of plaque from a lesion during ma-
`nipulation of body 12.
`Marker band 30, which is disposed at distal end 24, is
`preferably composed of a material that is detectable
`subcutaneously through the use of X-ray or fluoroscopy
`techniques, i.e., it is preferably radiopaque. As shown in
`FIG. 1, marker band 30 may be retained between soft
`tip 28 and tube 16 within recess 36. Of course, numerous
`other methods for disposing marker band 30 at distal
`end 24 will be readily apparent to those skilled in the
`art.
`
`Insertion wire 14 is attached to base portion 18 at
`proximal end 20 of tube 16, and preferably is perma-
`nently affixed thereto. For example, as best shown in
`FIGS. 1, 3 and 4, wire 14 may be connected to base
`portion 18 by inserting it into a receiving hole 34, and
`affixing it therein by, for example, gluing, pressure fit-
`ting, shrink fitting, or the like. Alternatively, tube 16
`may be molded directly onto application wire 14. Nu-
`merous other methods ofconnecting wire 14 to body 12
`will readily occur to those skilled in the art. It will be
`appreciated that this configuration, wherein tube 16 has
`an eccentric cross-section at base portion 18 and wire 14
`is affixed thereto, provides leverage for facilitating ma-
`nipulation of body 12.
`As shown in FIG. 1, a marker band 32 also may be
`disposed at the proximal end of bridge tube 16, e.g., on
`manipulating wire 14 adjacent base portion 18, and
`preferably is affixed thereto, e.g., by brazing or crimp-
`ing. Marker band 32 also is preferably composed of a
`material that is detectable subcutaneously, and most
`preferably is radiopaque.
`The size‘and shape of the various elements of support
`assembly 10 may vary depending on the desired applica—
`tion. In the application depicted in FIGS. 1 to 4, tube 16
`has a 0.055 inch outer diameter and lumen 22 has a 0.045
`inch diameter. (See, e.g., FIG. 2). At base portion 18,
`body 12 has a 0.065 inch outer diameter. (See, e.g., FIG.
`3). Body 12 is approximately 1 foot in length including
`approximately 1 inch of base portion 18 and approxi-
`mately 0.1 inch of funnel portion 26. Soft tip 28 is ar-
`ranged to extend coaxially from distal end 24 for about
`0.08 inch, and marker band 30‘is approximately 0.055
`inch inner diameter by 0.060 inch outer diameter by
`0.080 inch long. Wire 14 is 0.020 inch diameter stainless
`steel, and is generally at least about 50 inches long and
`preferably about 53 inches long (See, e.g., FIGS. 1 and
`4.) These sizes generally are suitable for existing PTCA
`catheters, such as the INTEGRA TM catheter mar-
`keted by Datascope Corp., the assignee of the present
`invention. Of course, other sizes may be used for other
`applications.
`As noted, these sizes may vary depending upon the
`application to which the device is to be put. When it is
`to be used with a PTCA catheter, lumen 22 should be at
`
`5
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`10
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`15
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`5,439,445
`
`_
`5
`least large enough to permit passage therethrough of
`the deflated PTCA balloon. For example, FIG. 5 is a
`side schematic view of the support assembly 10 of
`FIGS. 1 to 4 and a PTCA catheter 40, with the deflated
`balloon 48 resident in lumen 22 thereof. It is also be-
`lieved to be preferable for body 12 to be at least long
`enough for the entire PTCA balloon 48 to fit therein,
`although a somewhat longer body, Perhaps about 8
`times as long as the balloon 48 is believed most desir-
`able.
`
`Referring now to FIGS. 6A to GO, in one procedure
`for using the present invention, a physician inserts a
`guide catheter 38 through the aorta 37 and into a pa—
`tient’s coronary ostia 39 using known medical proce-
`dures.
`The physician then slides a PTCA catheter 40
`through L5 the body 12 until the distal tip 46 of the
`catheter reaches soft tip 28. (See, e.g., FIG. 5.) The
`balloon 48 of PTCA catheter 40 will then be captured
`within the confines of body 12. In this arrangement, the
`relatively fragile PTCA catheter balloon 48 will be
`safely surrounded by the more durable body 12 during
`insertion and maneuvering through the guide catheter
`38 and vascular system.
`Referring specifically to FIG. 6A, the PTCA cath-
`eter/support catheter assembly combination then is fed
`into .guide catheter 38, and advanced through guide
`catheter 38 to the distal end thereof. Feeding most ef—
`fectively is accomplished by exerting axial force on
`wire 14 and on catheter tube 50 simultaneously.
`Referring specifically to FIG. 6B, when the PTCA
`catheter/support
`catheter
`assembly
`combination
`reaches the distal end of guide catheter 38, it may be
`advanced as a unit out of the distal end of guide catheter
`38, into the coronary ostia 39. Alternatively, support
`assembly 10 can be advanced first, followed by PTCA
`catheter 40. Even if, in doing so, PTCA catheter 40
`comes out of the proximal end of body 12, funnel por-
`tion 26 facilitates reinsertion.
`It will be appreciated that body 12 generally will be
`able to pass further through the coronary ostia than can
`guide catheter 38 because it is smaller and more maneu-
`verable. Thus, body 12 may be inserted through the
`ostia and into the coronary artery (see FIG. 14). Even
`where body 12 cannot reach all the way to a stenotic
`region which must be opened, e.g., stenosis B in FIGS.
`6A to 6C, it will more often than not be able to reach
`closer to it than can guide catheter 38.
`When extending beyond the distal end of guide cathe-
`ter 38, body 12 functions as a guide catheter extension,
`and the gap that PTCA catheter 40 must negotiate
`without assistance is made much shorter. It will be
`appreciated that this procedure protects the fragile
`balloon 48 of the PTCA catheter 40 and lessens consid-
`erably the tendency of the PTCA catheter 40 to bend,
`buckle or kink.
`In the above procedure, it generally will be prefera-
`ble that at least some portion of proximal end 20 of body
`12 remains within guide catheter 38. To help ensure that
`proximal end 20 does not unintentionally em't from the
`guide catheter, the guide catheter may be provided with
`a marker ring 42 at its distal end. Marker ring 42 prefer-
`ably is composed of the same radiopaque material as
`marker band 30 and marker band 32, so that a physician
`can monitor the relative movement between body 12
`and guide catheter 38.
`Alternatively, or in addition, guide catheter 38 may
`be provided with a radially inwardly formed annular
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`6
`ridge 44 for impeding further axial movement of funnel
`26 beyond the distal end of guide catheter 38. Of course,
`since both funnel portion 26 and annular ridge 44 pref-
`erably are deformable, should it be necessary to have
`body 12 pass completely out of guide catheter 38, that
`can easily be accomplished. However, because of the
`outward flare of funnel 26 and the inwardly extending
`ridge 44, that is unlikely to occur accidentally.
`As shown in FIG. 6C, after body 12 is positioned
`adjacent the restricted area, PTCA catheter 40 is ad-
`vanced so that the balloon 48 exits body 12 and is ad-
`vanced into the restricted area, e.g., stenosis B, to be
`opened. Balloon 48 then is inflated, as represented by
`dotted lines 48’, to effect a well known angioplasty
`procedure. The balloon 48 then is deflated and the
`PI‘CA catheter 40, support catheter assembly 10 and
`guiding catheter 38 may be withdrawn, individually or
`in combination.
`FIG. 7 illustrates schematically another procedure in
`which body 12 is not long enough to reach from the
`guide catheter to the site where angioplasty is to be
`performed, e.g., stenosis B. In this case, the bridge body
`12/PTCA catheter assembly may be passed completely
`out of guide catheter 38 and advanced as a unit to the
`site of the restriction, stenosis B. Angioplasty then may
`be performed as described above, by passing the PTCA
`catheter 40 out of the distal end 24 of body 12 into the
`restriction formed by stenosis B.
`FIGS. 8A to SC illustrate schematically another pro-
`cedure for using the present invention, wherein body 12
`is used for sequentially reinforcing and advancing a
`PTCA catheter to two or more stenotic regions. Refer-
`ring specifically to FIG.'8A, the body/PTCA catheter
`assembly is advanced to a first restriction site, e.g.,
`stenosis A. PTCA catheter 40 is advanced so that bal-
`loon 48 exits the bridge body 12 into the restricted area
`of stenosis A, and balloon 48 is inflated, as represented
`by dashed lines 48’. As is well known in the art, inflation
`of balloon 48 compresses the stenotic walls to increase
`the size of the lumen therethrough, e.g., to enlarge the
`cross-section thereof. Balloon 48 then is deflated and
`PTCA catheter 40 may be advanced to the next restric-
`tion site, e.g., stenosis B. As shown in FIG. 8B, the
`PTCA catheter 40 then is advanced so that balloon 48 is
`resident in the restricted area of stenosis B, and balloon
`48 again is inflated, as represented by dashed lines 48’, to
`open the restricted area.
`Of course, after each angioplasty procedure the bal-
`loon 48 is deflated so that the PTCA catheter 40 may be
`advanced. Alternatively, when the balloon 48 is de—
`flated, the mini guide catheter (body 12) may be ad-
`vanced over the collapsed balloon 48, and then the mini
`guide catheter/PTCA catheter assembly may be ad-
`vanced as a single unit. This latter procedure provides
`protection to the relatively fragile balloon 48 and helps
`prevent bending, buckling or kinking of the PTCA
`catheter tube 50 as the PTCA catheter 40 is manipu-
`lated through the lesion.
`After angioplasty is performed, body 12 may be posi~
`tioned and retained in the previously restricted stenotic
`region. For example, FIG. 8B illustrates a procedure
`wherein body 12 is advanced to reside in the newly
`enlarged lumen of stenosis A, while the PTCA catheter
`is advanced to a second restriction site, stenosis B. FIG.
`8C illustrates a procedure wherein body 12 is advanced
`to reside both in the passage opened at stenosis A and
`the passage subsequently opened at stenosis B, and
`wherein the PTCA catheter 40 has been withdrawn. In
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`7
`this fashion, body 12 functions as a stent to prevent
`restenosis of the previously restricted areas, and to
`maintain an unrestricted flow passage therethrough,
`e.g., to ensure adequate perfusion of the artery prepara-
`tory to surgery.
`In yet another procedure for using the present inven-
`tion, support catheter assembly 10 may be used to facili-
`tate the exchange of one PTCA catheter for another,
`e.g., for one of a different inflation diameter. In this
`procedure, a first PTCA catheter is advanced through a
`patient’s vascular system to perform angioplasty using
`known procedures. When the physician wishes to ex-
`change the first PTCA catheter for a second one, body
`12 may be inserted and advanced through the guide
`catheter and to the newly opened stenosis. The deflated
`balloon 48 of the first PTCA catheter 40 then may be
`withdrawn, through body 12, until it exits from guide
`catheter 38, leaving both the guide catheter and the
`support catheter assembly in place. The second PTCA
`catheter then can be inserted. Because of funnel portion
`26, the second catheter can negotiate the transition from
`guide catheter 38 into body 12.
`,
`Referring again to FIG. 1, it also may be desirable to
`provide perforations 64 (shown in phantom) in tube 16
`of body 12. Such perforations would facilitate fluid flow
`through the area by providing greater influx and efflux
`through lumen 22. This structure also would provide
`influx and efflux through the wall of body 12 thereby to
`provide access for blood or other fluids to the cells of
`the coronary vessel wall or to the plaque formed
`thereon.
`As described in detail above, support catheter assem-
`bly 10 may be provided with markers, e.g., radiopaque
`markers, for subcutaneously detecting the position of
`body 12 during a medical procedure. Each of the guide
`catheter 38 and the PTCA catheter 40 also may be
`provided with one or more markers. Thus, it will be
`appreciated that a physician, through use of fluoros—
`copy or some similar technique, will be able to detect
`both the actual and relative locations of the various
`devices. More specifically, it will be appreciated that
`the physician will be able to detect, for example, when
`a PTCA catheter balloon 48 is captured by, or has fully
`exited from, body 12.
`Although the procedure described above contem-
`plates assembling body 12 and PTCA catheter 40 as a
`unit before passing them together into guide catheter
`38, such preassembly is not necessary. Body 12 could be
`inserted first, followed by the PTCA catheter 40. As
`discussed above, funnel portion 26 facilitates passage of
`the PTCA catheter 40 from the guide catheter 38 into
`lumen 22 of body 12.
`Alternatively, in another procedure the physician
`may prefer to insert the PTCA catheter 40 first, and use
`support catheter assembly 10 only when the need for it
`arises. This may occur, for example, where the physi-
`cian has inserted a PTCA catheter alone through the
`guide catheter, only to find that the PTCA catheter
`cannot negotiate the ostia and coronary artery between
`the distal end of the guide catheter and the restricted
`stenotic region. In this case, it may be desirable to pro-
`vide PTCA catheter 40 with a removable Y-fitting at its
`proximal end to permit passing body 12 over the PTCA
`catheter 40 after the latter has been advanced into the
`guide catheter. Copending US. application Ser. No.
`07/743,189 discloses a detachable/re-attachable Y-fit-
`ting that could be used for this purpose. It will be appre-
`ciated that when the Y-fitting is detached, body 12 of
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`the present embodiment will pass easily over the proxi—
`mal end of PTCA catheter tube 50. The Y—fitting then
`may be re—attached, and body 12 may be passed down
`through the guide catheter 38 with the PTCA catheter
`tube 50 functioning as a guide wire for the body 12.
`Although it is believed that the support assembly of
`the instant invention is most advantageously used in
`connection with a guide catheter, it may also be used
`independently. Referring to FIG. 9, the body 12 and ‘
`PTCA catheter 40 could be assembled as a unit and fed
`directly into the artery, either percutaneously or by an
`incision therein. Together, this assembly would then be
`advanced through the vascular system until it reaches a
`lesion L, with body 12 acting as a reinforcement to
`prevent buckling, kinking or bending of the distal end of
`the catheter.
`FIGS. 10 to 13 illustrate another embodiment of a
`support assembly in accordance with the present inven-
`tion. Referring to FIG. 10, a support assembly 110 is
`shown cut away in longitudinal cross-section. As in the
`prior embodiment, support assembly 110 is composed of
`two major elements: a body 112; and insertion/manipu-
`lation means. In this embodiment, the insertion/manipu-
`lation means takes the form of a manipulating extension
`tube. As in the prior embodiment, body 112 includes a
`body tube 116, a base portion 118 at theproximal end
`120 thereof, and a lumen 122 extending therethrough
`from the proximal end 120 to the distal end 124. Body
`112 also may include a soft tip 128 and distal marker
`band 130, as described in the prior embodiment.
`As shown in FIGS. 10 to 13, tube 116 and lumen 122
`are generally cylindrical and coaxial along the length of
`body 112, from proximal end 120 to distal end 124.
`Body tube 116 is dissimilar to tube 16 of the prior em-
`bodiment in that there is no enlarged wall section or
`flared out funnel at proximal end 120. Instead, base
`portion 118 is symmetrical about its axis, not eccentric.
`This symmetrical, generally cylindrical arrangement
`has a compact structure that, in some circumstances,
`may provide improved clearance through restricted
`areas in a blood vessel.
`Extension tube 114 extends coaxially from the proxi-
`mal end 120 of body 112. Extension tube 114 has a
`proximal end 152, a distal end 154 and a lumen 156
`extending therethrough from the proximal end 152 to
`the distal end 154. As shown in FIGS. 11 and 12, exten-
`sion tube 114 preferably has the same general cross-sec-
`. tion as body tube 116. However, as shown in FIGS. 10
`and 12, extension tube 114 also may be provided with a
`longitudinal slit 158 extending from the proximal end
`152 to head portion 160. Referring to FIGS. 10 and 13,
`extension tube 114 also may be provided with a funnel
`162 at its proximal end 152 for facilitating insertion of a
`catheter, e.g., a PTCA balloon catheter.
`As shown in FIG. 10, b