O
`
`United States Patent (19)
`Voda
`
`|||||||||||IIII
`11
`Patent Number:
`5,445,625
`45) Date of Patent:
`Aug. 29, 1995
`
`USOO5445625A
`
`63
`
`56
`
`4,925,445 5/1990 Sakamoto et al. .
`4,935,004 6/1990 Cruz .
`4,935,017 6/1990 Sylvanowicz .
`4,950,228 8/1990 Knapp, Jr. et al. .
`4,976,691 12/1990 Sahota ................................... 604/96
`4,981,477 1/1991 Schon et al. .
`4,983,166 1/1991 Yamawaki ............................ 604/96
`4,994,032 2/1991 Sugiyama et al. .................... 604/96
`5,000,743 3/1991 Patel .....................
`... 606/194
`5,035,686 7/1991 Crittenden et al. ................... 604/96
`(List continued on next page.)
`
`FOREIGN PATENT DOCUMENTS
`0132344A2 1/1985 European Pat. Off. .
`0277366A1 8/1988 European Pat. Off. .
`OTHER PUBLICATIONS
`Mallinckrodt "Diagnostic Catheters' brochure Oct.
`1990.
`
`(List continued on next page.)
`
`54 ANGIOPLASTY GUIDE CATHETER
`(76) Inventor: Jan Voda, 1404 Camden Way,
`Oklahoma City, Okla. 73116
`21 Appl. No.: 259,567
`aa.
`22 Filed:
`Jun. 14, 1994
`a
`is
`Related U.S. Application Data
`Continuation of Ser. No. 969,891, Oct. 30, 1992, aban-
`doned, Continuation-in-part of Ser. No. 622,873, Jan.
`23, 1991, abandoned.
`Int. Cl'............................................. A61M 25/OO
`D51
`52 U.S. C. ..................................... 604/281; 604/280
`58 Field of Search ............ 604/95, 96, 264, 281-282;
`606/194; 128/656-658,772
`References Cited
`U.S. PATENT DOCUMENTS
`3,935,857 2/1976 Co ...................................... 128/2.05
`3,938,501 2/1976 Erikson ............
`... 28/2A
`4,020,829 5/1977 Willson et al....
`Primary Examiner-C. Fred Rosenbaum
`... 128/2M
`4,033,331 7/1977 Guss et al. .......
`128/2 M Assistant Examiner-Mark Bockelman
`1220
`Attorney, Agent, or Firm-Nawrocki, Rooney &
`4,117,836 10/1978 Erikson ......
`4,169,464 10/1979 Obrez ...............
`... 128/65
`4,195,637 4/1980 Gruntzig et al.
`. .
`Sivertson
`ABSTRACT
`4,292,976 10/1981 Banka ...............
`... 128/656
`57
`... 604/283
`4,430,083 2/1984 Ganz et al.
`... 604/282
`An angioplasty guide catheter adapted for use within a
`4,547,193 10/1985 Rydell ..........
`... 264/39
`cardiovascular system and cooperable with a left main
`4,551,292 11/1985 Fletcher et al. .....
`4,563,181 1/1986 Wijayarathna et al.
`... 60/280
`coronary artery. The guide catheter has a distal end
`... 604/281
`a
`4,568,338 2/1986 Todd ....
`4,733,669 3/1988 Segal ................................... E.
`portion such that with a distal tip of the distalend pot
`4,738,667 4/1988 Galloway .
`tion coaxially intubated within 3. ostum of the left
`4,747,840 5/1988 Ladika et al. ....................... 604/281
`main coronary artery fully disposed within the cardio
`4,781,682 11/1988 Patel ...................................... 604/96
`vascular system, a portion of the distal end portion rests
`4,784,639 11/1988 Patel
`... 604/53
`against and is substantially contiguous with a wall of the
`4,790,831 12/1988 Skiibiski
`... 60/282
`ascending aorta. A distal end of the resting portion is
`4,813,930 3/i989 Elliott ................................... 604/53
`substantially directly opposite the ostium of the left
`: A. Earth".
`-
`a E2. main coronary artery and a portion of the distal end
`4,867,174 9/1989 Skribiski .............................. 2/72
`portion defines a generally rectilinear axis of support
`4,882,777 11/1989 Narula.
`extending from the distal end of the resting portion
`4,883,058 11/1989 Ruiz .................................... 128/654
`across the ascending aorta to the ostium of the left main
`4,886,506 12/1989 Lovgren et al. .................... 604/280
`coronary artery.
`4,898,577 2/1990 Badger et al. .
`604/282
`4,898,591 2/1990 Jang et al. ...
`4,909,787 3/1990 Danforth ............................... 604/95
`
`B
`7 Claims, 13 Drawing Sheets
`
`
`
`250
`
`322
`
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`
`U.S. PATENT DOCUMENTS
`5,044,369 9/1991 Sahota ................................. 128/658
`5,045,072 9/1991 Castillo et al.
`... 604/280
`5,058,595 10/1991 Kern .................................... 128/662
`5,059,197 10/1991 Urie et al. ........................... 606/16
`5,098,412 3/1992 Shiu ..................................... 604/280
`5,122,125 6/1992 Deuss.
`5,163,921 11/1992 Feiring ................................ 604/247
`5,195,990 3/1993 Weldon .
`5,203,776 4/1993 Durfee ................................ 604/264
`
`
`
`OTHER PUBLICATIONS
`Bourassa “Cardiovascular Catheters Sterile' brochure
`Jun. 1972.
`USCI “KIFA products' brochure pp. 1-12 Jun. 1974.
`USCI “KIFA products” brochure pp. 1-7 1967.
`“Coronary Arteriography and Angioplasty” Spencer
`B. King III, John S. Douglas pp. 182-238.
`USCI BlockTM Right Coronary Guiding Catheter,
`1989, 2 pages.
`USCI Video Tape (“Select Curve Guiding Catheter:
`Cannulating the Right coronary Artery') transcript and
`selected figures, 1988.
`USCI Video Tape: Select Curve Guiding Catheter Can
`nulating the Right Coronary Artery, USCI, C. R. Bard,
`1988.
`“Angled Tip of the Steerable Guidewire and Its Useful
`ness in Percutaneous Translumenal Coronary Angio
`
`plasty', Jan Voda, Use of Angled Guidewires in PTCA,
`1987, pp. 204-210.
`MediTech-Boston Scientific Corporation "Imager
`Angiographic Catheters' brochure Oct. 1990.
`U.S.C.I. Gruntzig Dilaca Coronary Dilatation Equip
`ment, U.S.C.I., C. R. Bard, Inc. 1990.
`U.S.C.I. “Postirol II and Nycore TM Cardiovascular
`Catheter'.
`Arani STE: A new catheter for angioplasty of the right
`coronary artery and aorta coronary bypass grafts, Cath.
`Cardiovasc. Diag. 11:647–658, 1985.
`Block, P. C. et al.: PTCA in perspective, U.S.C.I. Divi
`sion, C. R. Bard, Inc. Billerica, Mass., pp. 23-41, 1986.
`King S. B., III and Douglas S. Jr.: Coronary Arteriogra
`phy and Angioplasty, McGraw-Hill, New York, Chapter
`17, Percutaneous Transluminal Coronary Angioplasty, pp.
`433-452, 1985.
`Amplatz, K. et al., Mechanics of Selective Coronary Ar
`tery Catheterization via Femoral Approach, Radiology 89:
`1040-1047, Jul 1967.
`Judkins, M., Percutaneous Transfemoral Selective Coro
`nary Arteriography, Radiologic Clinics of North
`America-vol. VI, No. 3, Dec. 1968.
`Carr, M., The Use of the Guiding Catheter in Coronary
`Angioplastic. The Technique of Manipulating Catheters to
`Obtain the Necessary Power to Cross Tight Coronary Ste
`noses, Catheterization and Cardiovascular Diagnosis 12:
`189-197 (1986).
`
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`-- f2
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`/2
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`^
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`20
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`/3
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`A?---
`
`-
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`/3
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`F3
`/6
`ta.
`Sf 9 PRIOR ART
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`f3
`f
`Sfg PRIOR ART
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`
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`fig,
`
`PRIOR ART
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`602
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`60
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`1.
`
`ANGOPLASTY GUIDE CATHETER
`
`This is a continuation of application Ser. No.
`07/969,891 filed on Oct. 30, 1992 now abandoned
`which is a continuation-in-part of U.S. application Ser.
`No. 07/622,873, filed on Jan. 23, 1991 now abandoned,
`for GUIDE CATHETER CONSTRUCTION.
`
`5
`
`55
`
`5,445,625
`2
`Accordingly, the Judkins-type catheter presents sev
`eral difficulties when used for angioplasty procedures.
`Significantly, the principle problem associated with the
`use of a Judkins-type catheter as a guiding catheter is
`the lack of backup support which results in several
`undesirable consequences. When a Judkins-type guide
`catheter is disposed in the cardiovascular system and
`one attempts to push the balloon catheter distally across
`a tight stenosis, a resultant (opposite proximal) force is
`generated by the balloon catheter against the guide
`catheter. This problem is described in depth in Dan
`forth U.S. Pat. No. 4,909,787. The resultis that the tip of
`the Judkins-type catheter may become dislodged from
`the ostium of the left main coronary artery, i.e., the
`distal portion of the catheter "prolapses' and loses its
`preferred orientation within the ascending aorta and left
`main coronary artery. After this occurs, further ad
`vancement of the balloon (or other) working catheter
`becomes nearly impossible because the Judkins guiding
`catheter no longer provides adequate support to the
`highly flexible shaft of the balloon catheter as one at
`tempts to push the balloon catheter across the tight
`stenosis.
`Various attempts to solve this problem are described
`in the prior art. One of these attempted solutions is set
`forth in Danforth U.S. Pat. No. 4909,787 which de
`scribes a modified Judkins-type guiding catheter in
`which the "secondary curve' of the catheter includes a
`controllable stiffening means. This stiffening means is
`activated when the Danforth catheter is disposed within
`the cardiovascular system so that when one attempts to
`push a balloon catheter across a tight stenosis, the stiff
`ening means on the outer curvature of the secondary
`curve counters the force exerted against the guide cath
`eter because of the resistance of the stenosis. This stiff
`ening means is said to maintain enough rigidity in the
`guiding catheter to maintain the tip portion of the guid
`ing catheter within the ostium of the left main coronary
`artery thereby preventing prolapse of the guiding cathe
`ter. Similarly, Danforth U.S. Pat. No. 4,822,345 pro
`vides an inflatable/deflatable balloon 50 which works in
`a manner similar to the catheter in the Danforth U.S.
`Pat. No. 4909,787 to increase the rigidity of the distal
`end of the guiding catheter. Both of these references
`describe modified Judkins-type guide catheters in
`which it was attempted to increase balloon catheter
`backup support by increasing the stiffness of the outer
`curvature of the distal end portion of the guide catheter
`and thus prevent the guide catheter from prolapsing
`during balloon catheter advancement distally across a
`stenosis. Neither of the Danforth patents attempted to
`make a fundamental change in the overall shape/con
`figuration of the Judkins-type guide catheter to solve
`the problem of inferior backup support.
`Shiu U.S. Pat. No. 5,098,412 describes a Judkins-type
`guide catheter having a secondary lumen in addition to
`a main lumen through which a balloon catheter passes.
`The secondary lumen structure is separable from the
`main lumen at the distal portion so that when a distal
`end of the main lumen of the guide catheter is intubated
`in the ostium (LMCA), the secondary lumen is moved
`away from the main lumen (at the distal portion) and
`may be braced against the opposed walls of a vessel to
`retain the position of the guide catheter. As in the other
`attempted solutions to the problem of balloon catheter
`backup support, the Shiu approach adds bulky complex
`structure to a Judkins guide catheter instead of funda
`mentally altering the basic configuration of the Judkins
`
`O
`
`15
`
`BACKGROUND OF THE INVENTION
`This invention relates generally to catheters adapted
`to be inserted into the cardiovascular system of a living
`body and, more particularly, to an improved catheter
`having an improved distal end portion for more precise
`location in the particular artery of the cardiovascular
`system.
`Catheters are often used in the performance of medi
`cal procedures such as coronary angiography for inject
`20
`ing dye, or the like, into the cardiovascular system for
`diagnosis; and angioplasty to widen the lumen of a coro
`nary artery which has become at least partially blocked
`by a stenotic lesion causing an abnormal narrowing of
`the artery due to injury or disease. In these techniques
`25
`the distal end of the catheter is introduced into the aorta
`by way of the femoral artery. The proximal end of the
`catheter is then manipulated so its distal end is inserted
`into the lumen of a selected coronary artery branching
`off from the aorta. A typical angioplasty procedure
`30
`would involve initially inserting a guiding catheter into
`the cardiovascular system in the above manner, fol
`lowed by a dilating catheter, a laser catheter, an
`atherectomy catheter, or the like, which is guided
`through the guiding catheter until its distal end portion
`is positioned within the stenotic lesion in the coronary
`artery to reduce the blockage in the artery. A diagnostic
`catheter would be used in the same manner.
`The most common catheter used in treatment of the
`left coronary artery is what is often referred to as a
`“Judkins' catheter which has a specially shaped distal
`end portion for facilitating insertion into the artery.
`However, as will be specifically discussed, there are
`some disadvantages to the "Judkins' catheter, including
`its inability to align perfectly coaxially with selected
`45
`artery and thus permit optimum treatment, and its in
`ability to adequately support other devices such as bal
`loon catheters. Also, the Judkins catheter forms rela
`tively large angles when inserted into the cardiovascu
`lar system thus dissipating some of the axial forces trans
`50
`mitted through the catheter during use.
`The Judkins-type catheter originally was designed
`and used for diagnostic angiography. However, with
`the advent of angioplasty, the Judkins-type catheter has
`been used routinely for about the last fourteen years to
`guide balloon catheters and other intravascular devices
`through the vasculature to the left main coronary ar
`tery. The overall shape/configuration of the Judkins
`type catheter has remained basically the same through
`out this period. Although some variations in its shape/-
`configuration were made, the basic overall shape of the
`Judkins-type catheter has not been specifically adapted
`for the unique needs dictated by angioplasty proce
`dures. Instead, the Judkins-type catheter (as commonly
`used in a left femoral approach technique for intubating
`65
`the left main coronary artery) has been adapted only
`slightly from its original configuration that was de
`signed for diagnostic angiographic procedures.
`
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`5
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`25
`
`5,445,625
`3
`4.
`guide catheter to solve the problem. Despite the modifi
`for advancing a balloon catheter across a stenosis, is
`cation of the Judkins guide catheter, the Shiu guide
`extremely difficult and not practical with the Judkins
`catheter retains the overall configuration of the Judkins
`guide catheter. Moreover, this 90 primary curve also
`catheter that results in the apex of the secondary curve
`generally limits the distance which the distal tip portion
`portion of the Judkins-style guide catheter “banking” of
`may be intubated into the left main coronary artery.
`the wall of the ascending aorta at a location substan
`Similarly, this misalignment of the tip portion pre
`tially above the ostium.
`vents the full transfer of pushing force from the proxi
`Other solutions include trying to "lock” the tip por
`mal end of the balloon catheter to the distal end of the
`tion of the Judkins-type guiding catheter within the
`balloon catheter because the balloon catheter must bend
`ostium of the left main coronary artery. For example,
`around the steeply angled primary curve tip portion of
`Patel U.S. Pat. No. 5,000,743 discloses an inflatable
`the Judkins-type catheter before aligning properly
`balloon on the distal end of the guide catheter for secur
`within the ostium and lumen of the left main coronary
`ing the distal end within the lumen of a coronary artery.
`artery. This problem with the Judkins guide catheter
`Alternatively, Patel U.S. Pat. No. 4,781,682 discloses
`when used for angioplasty is directly attributable to the
`another type of Judkins-type guide catheter with a
`belief that one must prevent intubation of the Judkins
`"locking” device consisting of support flaps, which
`guide catheter within the ostium and the LMCA. This
`expand from the outer surface of the guide catheter, to
`belief was based on the strong reluctance to put such a
`anchor the distal end portion of the guide catheter adja
`catheter into the left main coronary artery because of
`cent the left main coronary artery. However, these
`the relatively large size of diagnostic catheters at time
`attempted solutions have their own undesirable results.
`of development of the Judkins catheter.
`The former solution impedes blood flow through the
`Moreover, the 90° angle primary curve causes partic
`left main coronary artery and the latter solution intro
`ular problems when attempting to maneuver a balloon
`duces additional bulky structure into the cardiovascular
`catheter into the circumflex branch of the left main
`system which may hamper the blood flow and interfere
`coronary artery. The circumflex branch extends from
`with the functioning of the aortic valve. Similarly,
`the ostium in the left main coronary artery in a direction
`Duess U.S. Pat. No. 5,122,125 describes a Judkins-type
`almost directly opposite the exit of the balloon catheter
`guide catheter having a "centering” or "locking' top
`from the distal tip portion of the 90 primary curve of
`portion in which ridges on the outer surface of the distal
`the Judkins guide catheter. Accordingly, when attempt
`tip portion effectively wedge against the inner walls of
`ing to maneuver a balloon catheter into the circumflex
`an ostium to center the tip portion within the ostium.
`30
`branch, the balloon catheter must first negotiate the 90'
`This feature is said to allow proper blood flow around
`primary curve of the Judkins catheter and then com
`the distal tip portion as well as effectively "anchor' the
`pletely reverse direction (about 180') to enter the cir
`distal tip portion within the ostium thereby insuring
`cumflex branch of the left main coronary artery. This
`stable and precise positioning of the guide catheter.
`significantly attenuates pushing forces transmitted from
`These previous modifications of the Judkins catheter
`the proximal end of the balloon catheter to the balloon
`for angioplasty have not addressed the primary reason
`portion 10 thereby making the crossing of a lesion or
`for frequent prolapse of the Judkins-type guide catheter
`stenosis much more difficult.
`when advancing a balloon catheter across a stenosis: the
`However, the sharp 90° angle of the primary curve is
`overall shape of the Judkins guide catheter (prior to
`not the only feature of the shape of the Judkins guide
`insertion in the cardiovascular system) is poorly de
`catheter that hampers coaxial placement and stable
`signed for angioplasty purposes. There are several fea
`positioning of the distal tip portion within the ostium of
`tures of the basic shape of the Judkins guide catheter
`the left main coronary artery. The other main feature of
`(for left main coronary arteries or “LMCA') that cause
`the Judkins guide catheter (for LMCA) is a long
`poor performance in using Judkins or slightly modified
`straight segment extending distally of the secondary
`Judkins guide catheters in angioplasty procedures.
`45
`curve (and proximal of the primary curve) and the
`The main deficiency in the previous attempted modi
`absence of any other significant curves formed along
`fications of the Judkins catheter (as used for guide cath
`the length of the catheter (other than the conventional
`eter purposes in the LMCA) has been a lack of appre
`180 secondary and conventional primary curve). This
`ciation for the extent to which the shape of the Judkins
`creates several consequences which combine to cause
`guide catheter prior to insertion in the cardiovascular
`non-coaxial ostial positioning and poor backup support
`system affects its performance (i.e., coaxial positioning,
`of the Judkins guide catheter for LMCA.
`backup support) when the Judkins guide catheter is
`The first consequence of having the long straight
`disposed within the cardiovascular system.
`segment extending distally of 180 secondary curve is
`The first deficiency in the shape of the Judkins cathe
`that when the distal tip and primary curve portion of
`ter is that the primary curve of the Judkins guiding
`55
`the Judkins guide catheter are positioned within the
`catheter forms a 90 right angle prior to insertion in the
`ostium of the LMCA, the long straight segment of the
`cardiovascular system and is relatively inflexible (the
`Judkins guide catheter distal of the secondary curve
`primary curve corresponds to the first curve in the
`(and proximal to the primary curve) extends upwardly
`catheter proximal of its utmost distal end). This causes
`the distal tip portion of the Judkins-type catheter to be
`from the ostium and across the ascending aorta at a
`incapable of aligning coaxially within the ostium of the
`substantial (i.e., sharp) angle so that the Judkins guide
`left main coronary artery. The 90' angle of the primary
`catheter contacts the wall of the ascending aorta sub
`curve hampers the ability of the balloon catheter to exit
`stantially above the ostium of the LMCA. After con
`the tip portion of the guiding catheter because this fre
`tacting the wall of the ascending aorta, the Judkins
`quently causes the balloon catheter to exit the tip por
`guide catheter extends proximally away from the aortic
`65
`tion into the wall of the left main coronary artery. Ac
`wall at a substantial angle (relative the aortic wall)
`cordingly, deep intubation of the distal tip portion
`toward the arch of the aorta before again contacting a
`within the ostium, which is desirable to increase support
`wall of the descending aorta adjacent the arch of the
`
`35
`
`50
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`6
`aorta. Thus, the Judkins guide catheter effectively
`the distal tip) of the Judkins catheter from the ostium
`when advancing the balloon catheter. Prolapse of the
`banks off the wall of the ascending aorta.
`The long straight segment extending distally of the
`Judkins guide catheter occurs because the "pushback
`180 secondary curve portion is significant because it is
`forces' are directed along an axis generally parallel to
`that segment which allows the distal end portion of the
`the ostium of the left main coronary artery through the
`ascending aorta whereas the Judkins guide catheter
`Judkins catheter to become anchored within the aortic
`root complex. This long straight segment (distal of the
`point of support is a small contact point substantially
`secondary curve portion) is noticeably longer than the
`above the ostium. The stenotic "pushback” forces tend
`diameter of the ascending aorta and has the following
`to push the distal tip portion of the Judkins catheter out
`effect: when the utmost distal tip and primary curve
`of the ostium and toward the opposite wall of the as
`cending aorta. During this prolapse of the distal tip
`portion of the Judkins catheter are intubated within the
`ostium of the left main coronary, the long straight seg
`portion, the apex of the secondary curve of the Judkins
`ment (distal of the secondary curve portion) becomes
`catheter rests against the aortic wall and acts as a hinge
`allowing the straight portion (distal of the secondary
`"wedged', i.e., anchored between the ostium (of
`LMCA) and the wall of the ascending aorta (where the
`curve) to bend backwards toward the opposite wall.
`apex of the secondary curve portion contacts the wall).
`The prolapse of the Judkins guide catheter when
`Without this long straight segment distal of the second
`advancing a balloon catheter is a direct consequence of
`ary curve portion, the Judkins guide catheter would slip
`having a small point of contact against the aortic wall
`against the wall of the ascending aorta as one attempted
`substantially above the ostium. The Judkins guide cath
`eter lacks support to counter pushback forces where it
`to further advance the guide catheter into the ostium,
`20
`thereby causing unstable positioning of the Judkins
`needs it most; directly across from the ostium. The basic
`guide catheter.
`positioning of the Judkins guide catheter within the
`Accordingly, the long straight segment distal of the
`cardiovascular system and ascending aorta is dictated
`secondary curve portion of the Judkins guide catheter is
`by the basic shape of the catheter when in a relaxed
`state prior to insertion. In particular, the long straight
`made appreciably longer than the diameter of the as
`25
`cending aorta so that this "wedging' phenomena oc
`segment extending distally from the 180' secondary
`curs. It is because this long distal straight segment is
`curve (and lack of other curves throughout the length
`appreciably longer than the diameter of the ascending
`of the catheter other than the primary curve) result in
`this positioning within the ascending aorta substantially
`aorta that the apex of the secondary curve portion
`contacts the ascending aortic wall substantially above
`above the ostium of the left main coronary artery.
`30
`the ostium of the left main coronary artery.
`Moreover, recall that attempted solutions (in the Dan
`forth patents) to rectify the prolapse problem of the
`The portion of the Judkins guide catheter that
`contacts or “banks off the ascending aortic wall (the
`Judkins guide catheter did not recognize that the basic
`contact portion) corresponds roughly to the apex of the
`shape of the Judkins guide catheter was the cause of the
`curvature of the 180° bend secondary curve. This
`prolapse but rather merely added structure to the same
`35
`contact portion is relatively small and approximates a
`basic shape in an attempt to prevent prolapse. Likewise,
`the Patel patents did not recognize that the problem of
`single point on a line such that the contact portion will
`act as a localized pressure point on the wall of the as
`prolapse is caused by the basic shape of the Judkins
`cending aorta. It is generally desirable to spread out any
`catheter but rather tried to anchor the distal tip portion
`pressure exerted on a wall of a blood vessel such as the
`of the catheter near the aortic root to “lock” the guide
`ascending aorta.
`catheter within the aortic complex near the ostium.
`More importantly, the small size of the contact por
`None of the attempted solutions recognize, much less
`tion in its location substantially above (not directly
`solve, the problem with the Judkins guide catheter-its
`basic shape prior to insertion in the cardiovascular sys
`across from) the ostium of the LMCA directly cause the
`poor backup support of the Judkins guide catheter
`tem--a combination of a primary curve with a 90 an
`45
`gle, a 180 secondary curve with a long straight seg
`when advancing a balloon catheter across a stenosis.
`ment extending distally therefrom, and no other curves
`First, because the surface area of contact between the
`throughout the length of the catheter. This configura
`contact portion and the aortic wall is so small, the Jud
`kins guide catheter is much easier to dislodge from its
`tion results in the absence of a point or axis of support
`position against the wall when resistive "pushback”
`directly across from or opposite the ostium of the left
`50
`main coronary artery.
`forces are encountered during advancement of a bal
`loon catheter across a stenosis. Moreover, the straight
`Another problem with the Judkins guide catheter is
`portion of the Judkins guide catheter (distal of the sec
`that each bend in the Judkins guide catheter (when
`ondary bend) extends downward through the ascending
`disposed fully in the aorta complex) forms at least a 90
`aorta substantially lateral relative to the contact por
`angle and or an acute angle (less than 90). Acute (or
`55
`tion. This allows the stenotic "pushback' forces to
`90) angles in the Judkins catheter cause great resistance
`to pushing the balloon catheter through the Judkins
`more easily overcome the friction of the small contact
`guide catheter. This happens because the Judkins cathe
`area between the Judkins guide catheter and the aortic
`wall and dislodge the Judkins guide catheter from the
`ter prior to insertion has only two large curves includ
`ing the 180 (or 150) secondary curve and the 90 pri
`desired orientation in the aortic complex. However, the
`potential for dislodging the Judkins catheter from its
`mary curve, and has no other curved portions through
`desired position is not the most disadvantageous aspect
`out its length.
`resulting from the overall configuration of the 180
`This is significant because the catheter must trace a
`secondary curve, 90 primary curve and absence of
`180 path around the arch of the aorta and then another
`90 turn into the ostium of the left main coronary artery
`other curved portions in the Judkins guide catheter.
`65
`As explained earlier, the most significant problem
`creating an overall path from the descending aorta to
`associated with the basic shape of the Judkins guide
`the ostium of the LMCA of about 270. Having fewer
`catheter is prolapse (i.e., retracting or "backing out” of
`curves in the catheter prior to insertion in the cardiovas
`
`Page 18
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`5,445,625
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`cular system means that as the guide catheter traces this
`port provided by the guide catheter include the follow
`270 path each curve will form a greater (i.e., sharper)
`ing. First, coaxial intubation of a distal tip of the guide
`angle and thus, each acute angle will proportionately
`catheter within the ostium of the left main coronary
`reduce the transmission of pushing forces when distally
`artery. Second, the lack of steep bends or acute angles
`advancing a balloon catheter. Conversely, having more
`throughout the length of the guide catheter when de
`curves throughout the length of the catheter in a re
`ployed in the cardiovascular system. Third, a point of
`laxed state prior to insertion in the cardiovascular sys
`support of the guide catheter against the wall of the
`ascending aorta that is directly across from the ostium
`tem will mean that each curve can form a more moder
`ate (obtuse) angle when the guide catheter is disposed in
`of the left main coronary artery. Fourth, a large sup
`the cardiovascular system and in particular, the aortic
`portive segment of the guide catheter that rests against
`arch and ascending aorta. This allows for an overall
`the wall of the ascending aorta to increase stability of
`better transmission of pushing forces because no single
`the guide catheter within the aortic complex. Fifth,
`providing a substantially rectilinear axis of support be
`curve will form less than a 90° angle.
`The problem of 90° or acute angled (90° or less) bends
`tween the ostium of the left main coronary artery and
`the point of support against the wall of the ascending
`in the Judkins catheter when fully disposed in the aortic
`complex illustrates the poor design of the Judkins guide
`aorta. Sixth, providing a straight portion which extends
`catheter for supporting distal advancement of a balloon
`proximally from and at a substantial angle relative to the
`catheter through the Judkins guide catheter. Had the
`proximal end of the supportive segment that contacts
`Judkins catheter been designed for angioplasty, the
`the aortic wall. Providing a configuration of a guide
`configuration of the Judkins guide catheter would in
`catheter, such as the present invention, which focuses
`20
`corporate a combination of curved portions so that
`on combining all of these factors to provide an optimal
`when disposed in the aorta, the angles of the bends
`guide catheter results in a guide catheter that functions
`appreciatively better than the Judkins guide catheter or
`would be milder, i.e., obtuse, to facilitate a fuller trans
`mission