BSC USP 8,048,032
`Exhibit 1005
`
`Page 1 of 21
`
`I 1111NIllillINIIIN11111 1111uN11111HIN111111111 INII IIOil III
`
`US008142413B2
`
`(12) United States Patent
`Root et al.
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 8,142,413 B2
`Mar. 27, 2012
`
`(54) COAXIAL GUIDE CATHETER FOR
`INTERVENTIONAL CARDIOLOGY
`PROCEDURES
`
`(75)
`
`Inventors:
`
`Howard Root, Excelsior, MN (US);
`Gregg Sutton, Maple Grove, MN (US);
`Jeffrey M. Welch, Maple Grove, MN
`(US); Jason M. Garrity, Minneapolis,
`MN (US)
`
`(73) Assignee: Vascular Solutions, Inc., Minneapolis,
`MN (US)
`
`*) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 0 days.
`
`(21) Appl. No.: 12/824,734
`
`(22) Filed:
`
`Jun. 28, 2010
`
`(65)
`
`Prior Publication Data
`
`US 2010/0324567 Al
`
`Dec. 23, 2010
`
`Related U.S. Application Data
`
`(62) Division of application No. 11/416,629, filed on May
`3, 2006, now Pat. No. 8,048,032.
`
`(51)
`
`Int.Cl.
`(2006.01)
`A61M31/OO
`(2006.01)
`A61M25/OO
`(2006.01)
`A6IM 5/1 78
`604/510; 604/164.1; 604/525
`(52) U.S. Cl
`(58) Field of Classification Search
`604/103.04,
`604/103.09, 16—162, 164.01—1 64.11, 525,
`604/5 10
`See application file for complete search history.
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`4,813,930 A
`3/1989 Elliott
`5/1989 Patel
`4,832,028 A
`4,932,413 A
`6/1990 Shockey et al.
`
`5,098,412 A
`5,122,125 A
`5,472,425 A
`5,658,263 A
`5,776,141 A
`6,159,195 A
`6,338,725 BI
`6,475,195 81
`6,595,952 B2
`6,610,068 81
`6,638,268 B2 ~
`6,689,144 32
`6,706,018 B2
`
`3/1992 Shiu
`6/1992 Deuss
`12/1995 Teirstein
`8/1997 Dang et al.
`7/1998 Klein Ct al.
`12/2000 Haetal.
`1/2002 Hermann et al.
`11/2002 Voda
`7/2003 Forsberg
`8/2003 Yang
`10/2003 Niazi
`2/2004 Gerberding
`3/2004 Westlund et al.
`(Continued)
`
`604/528
`
`OTHER PUBLICATIONS
`
`Saeko Talcahashi et al.; New Method to Increase a Backup Support of
`a 6 French Guiding Coronary Catheter; Catheterization and Cardio
`vascular Interventions 63 :452-456 (2004), 5 pages; Published online
`in Wiley InterScience (www.interscience.wiley.com).
`
`(Continued)
`
`Primary Examiner — Bhisma Mehta
`Assistant Examiner — Bradley Osinksi
`(74) Attorney,
`Agent,
`or Firm — Patterson
`Christensen Pedersen PA
`
`Thuente
`
`(57)
`
`ABSTRACT
`
`A coaxial guide catheter to be passed through guide catheter
`having a first lumen, for use with interventional cardiology
`devices that are insertable into a branch artery that branches
`off from a main artery. The coaxial guide catheter is extended
`through the lumen of the guide catheter and beyond the distal
`end of the guide catheter and inserted into the branch artery.
`The device assists in resisting axial and shear forces exerted
`by an interventional cardiology device passed through the
`second lumen and beyond the flexible distal tip portion that
`would otherwise tend to dislodge the guide catheter from the
`branch artery.
`
`14 Claims, 13 Drawing Sheets
`
`

`
`Page 2 of 21
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`US 8,142,413 B2
`Page 2
`
`U.S. PATENT DOCUMENTS
`6,755,812 B2
`6/2004 Peterson et al.
`6,860,876 B2
`3/2005 Chen
`7,697,996 B2
`4/20 10 Manning et a!.
`7,717,899 B2
`5/2010 Bowe et ~J.
`2003/0 195546 Al
`10/2003 Solar et a!.
`2004/0127927 Al
`7/2004 Adams
`
`2005/0004523 Al ‘~
`2005/0182437 Al
`2007/02602 19 Al
`
`1/2005 Osborne et al
`8/2005 Bonnette et al.
`11/2007 Root et al.
`
`604/164.01
`
`OTHER PUBLICATIONS
`U.S. App!. No. 11/416629, filed Jun. 28, 2010, Howard Root et a!.
`
`* cited by examiner
`
`

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`Page 3 of 21
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`U.S. Patent
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`Mar. 27, 2012
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`Sheet 1 of 13
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`US 8,142,413 B2
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`Mar. 27, 2012
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`US 8,142,413 B2
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`2
`backup support or the appendage may be placed under ten
`sion to stiffen a bend in the catheter to provide backup sup
`port. Examples of this approach may be found in U.S. Pat.
`Nos. 4,813,930 issuedto Elliot; 5,098,412 issuedto Shio; and
`5 6,860,876 issued to Chen. These guiding catheters tend to be
`somewhat mechanically complex and have not been widely
`adopted by practitioners.
`Third are guide catheters that have a portion that seeks to
`expand laterally to grip the interior wall of the ostiom of the
`10 coronary artery to provide a force acting in opposition to the
`
`1
`COAXIAL GUIDE CATHETER FOR
`INTERVENTIONAL CARDIOLOGY
`PROCEDURES
`
`RELATED APPLICATION
`
`This application is a division of application Ser. No.
`11/416,629 filed May 3, 2006, now U.S. Pat. No. 8,048,032
`which is hereby fully incorporated herein by reference.
`
`FIELD OF THE INVENTION
`
`The present invention relates generally to catheters used in
`interventional cardiology procedures. More particularly the
`present
`invention relates to methods and apparatus for
`increasing backup support for catheters inserted into the coro
`nary arteries from the aorta.
`
`BACKGROUND OF THE INVENTION
`
`Interventional cardiology procedures often include insert
`ing goidewires or other instruments through catheters into
`coronary arteries that branch off from the aorta. For the pur
`poses of this application, the term “interventional cardiology
`devices” is to be understood to include but not be limited to
`guidewires, balloon catheters, stents and stent catheters. In
`coronary artery disease the coronary arteries may be nar
`rowed or occluded by atherosclerotic plaques or other lesions.
`These lesions may totally obstruct the lumen of the artery or
`may dramatically narrow the lumen of the artery. Narrowing
`is referred to as stenosis.
`In order to diagnose and treat
`obstructive coronary artery disease it is commonly necessary
`to pass a goidewire or other instruments through and beyond
`the occlusion or stenosis of the coronary artery.
`In treating a stenosis, a guide catheter is inserted through
`the aorta and into the ostium of the coronary artery. This is
`sometimes accomplished with the aid of a guidewire. A guide
`catheter is typically seated into the opening or ostium of the
`artery to be treated and a guidewire or other instrument is
`passed through the lumen of the guide catheter and inserted
`into the artery beyond the occlusion or stenosis. Crossing
`tough lesions can create enough backward force to dislodge
`the guide catheter from the ostium of the artery being treated.
`This can make it difficult or impossible for the interventional
`cardiologist to treat certain forms of coronary artery disease.
`Prior attempts to provide support to the guiding catheter to
`prevent backward dislodgement from the coronary ostium
`(referred to as “backup support”) fall generally into four
`categories.
`First are guiding catheters that, through a combination of
`shape and stiffness, are configured to draw backup support
`from engaging the wall of the aortic arch opposing the ostium
`of the coronary artery that is being accessed. Examples of this
`approach can be found in U.S. Pat. No. 6,475,195 issued to
`Voda and U.S. Pat. No. 5,658,263 issuedto Daog et al. These
`guiding catheters all share the common limitation that a guide
`catheter stiff enough to provide adequate backup support is
`often too stiff to be safely inserted into the aorta without the
`possibility of causiog damage to the aortic wall. In addition,
`attempts to deep seat the guide catheter have been made but
`the rigid nature of the guide catheter creates the risk that the
`guide catheter may damage the coronary artery wall or that
`the guide catheter may occlude the coronary artery and inter
`fere with blood flow to the heart muscle.
`Second are guiding catheters that
`include a retractable
`appendage. The appendage in these catheters can be extended
`to engage the opposing wall of the aortic arch to provide
`
`20
`
`backward forces created when trying to maoeuver a therapeu
`tic device past a lesion or blockage in the coronary artery.
`These devices can include a balloon secured to a goidewire or
`a catheter or another device for expanding to grip the walls of
`the coronary artery from within. Examples of this approach
`may be found in U.S. Pat. Nos. 4,832,028 issued to Patel;
`6,595,952 issued to Forsberg; and U.S. PublishedApplication
`No. 2005/01 82437 by Bonnette et al. Again, these devices
`tend to be mechanically complex and can completely occlude
`the coronary ostium thus stopping perfusion of the coronary
`artery.
`A fourth technique includes the placement of a smaller
`guide catheter within a larger guide catheter in order to pro-
`25 vide added support for the crossing of lesions or for the distal
`delivery of balloons and stents. This technique has been
`described in an article by Takahashi entitled “New Method to
`Increase a Backup Support of Six French Guiding Coronary
`Catheter,” published in Catheterization and Cardiovascular
`30 Interventions, 63:452-456 (2004). This technique is used in
`order to provide a method of deep seating the guide catheter
`within the ostiom of the coronary artery. Deep seating refers
`to inserting the catheter more deeply into the ostium of the
`coronary artery than typically has been done before. Unfor
`tonately, deep seating by this technique with a commonly
`available guide catheter creates the risk that the relatively
`stiff, fixed curve, guide catheter will damage the coronary
`artery. This damage may lead to dissection of the coronary
`artery when the catheter is advanced past the ostium.
`Several other problems arise when using a standard guide
`catheter in this catheter-in-a-catheter fashion. First, the inner
`catheters most be substantially longer than the one hundred
`centimeter guide catheter. Second, a new hemostasis valve
`must be placed on the im2er guide catheter which prevents the
`45 larger guide catheter from being used for contrast injections
`or pressure measurements. Third, the smaller guide catheter
`still must be inserted into the coronary vessel with great care
`since the smaller guide catheter has no tapered transition or
`dilator at its tip and does not ron over a standard 0.014 inch
`50 goidewire.
`Thus, the interventional cardiology art would benefit from
`the availability of a system that would be deliverable through
`staodard guide catheters for providing backup support by
`providing the ability to effectively create deep seating in the
`55 ostium of the coronary artery.
`
`35
`
`40
`
`SUMMARY OF THE INVENTION
`
`The present invention is a coaxial guide catheter that is
`60 deliverable through standard guide catheters by utilizing a
`guidewire rail segment to permit delivery without blocking
`use of the guide catheter. The coaxial guide catheter prefer
`ably includes a tapered inner catheter that roos over a standard
`0.0 14 inch coronary guidewire to allow atraumatic placement
`65 within the coronary artery. This feature also allows removal of
`the tapered inner catheter after the coaxial guide catheter is in
`place. The tapered inner catheter provides a gradual transition
`
`

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`Page 17 of 21
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`US 8,142,413 B2
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`3
`from the standard 0.014 inch diameter guidewire to the diam
`eter of the coaxial guide catheter which is typically five to
`eight French.
`The coaxial guide catheter preferably cao be delivered
`through commonly existing hemostatic valves used with
`guide catheters while still allowing injections through the
`existing Y adapter.
`In addition,
`the coaxial guide catheter
`preferably has an inner diameter that is appropriate for deliv
`ering standard coronary treatment devices after it is placed in
`the coronary artery.
`In one embodimeot, the coaxial guide catheter is made in at
`least three sizes corresponding to the internal capacity of 8
`French, 7 French, and 6 French guide catheters that are corn
`monly used in interventional cardiology procedures. An 8
`French catheter has an internal diameter greater than or equal
`to 0.088 inches. A 7 French catheter has an internal diameter
`greater than or equal to 0.07 8 inches. A 6 French guide cath
`eter has an internal diameter greater than or equal to 0.070
`inches. Thus, for three exemplary sizes the effective internal
`diameter of the coaxial guide catheter maybe as follows. For
`a 7 French in 8 French coaxial guide catheter the internal
`diameter should be greater than or equal to 0.078 inches. For
`a 6 French in 7 French coaxial guide catheter the internal
`diameter should be greater than or equal to 0.070 inches. For
`a 5 French in 6 French coaxial guide catheter the internal
`diameter should be greater than or equal to 0.05 6 inches.
`Interventional cardiology procedures are typically carried
`out under fluoroscopy or another x-ray or imaging technique.
`Therefore, one embodiment of the coaxial guide catheter of
`the present invention includes a radiopaque marker at
`its
`distal tip to facilitate positioning and manipulation of the
`coaxial guide catheter.
`The present invention generally includes the coaxial guide
`catheter and a tapered inner catheter. The coaxial guide cath
`eter includes a tip portion, a reinforced portion, and a sub
`stantially rigid portion. The coaxial guide catheter will gen
`erally have an overall length of preferably approximately 125
`cm, though this should not be considered limiting.
`In one embodiment, the tip portion may include a soft tip
`and a nsarker band. The soft tip is tapered and may be formed
`from a low durometer polymer or elastomer material such as
`pol5jether block amide polymer, (PEBA, Pebax®) the marker
`band may be fonned from a platinum iridium alloy sand
`wiched between the Pebax® that extends from the bump tip
`and a PTFE liner.
`In one embodiment, the reinforced portion may be rein
`forced, preferably with metallic fibers in a braided or coiled
`pattern. The braided or coiled portion is lined by a PTFE liner
`and may be covered on its exterior with Pebax®. The braided
`or coiled portion may extend approximately 20 to 110cm in
`length. In one exemplary embodiment, the braided portion
`extends approximately 32 to 36 cm.
`Preferably,
`the rigid portion may be advantageously
`formed from a stainless steel orNitinol tube. The rigid portion
`may be joined to the braid or coil portion by welding. The
`rigid portion may include a cutout portion and a full circum
`ference portion. For example, the cutout portion may include
`a section where about 45% of the circumference of the cylin
`drical tubular structure has been removed. The cutout portion
`may also include a section where 75 -90% of the circumfer
`ence of the tubular structure has been removed. In one exem
`plary embodiment, the portion having approximately 45%
`removed may extend for approximately 75 cm and the portion
`having 75-90% of the structure removed extends for about 15
`cm. The hill circumference portion of the rigid portion is
`typically located at the most proximal end ofthe coaxial guide
`catheter.
`
`15
`
`25
`
`35
`
`4
`The rigid portion may include a plurality of radially ori
`ented slits or other cuts in its distal portion to increase and
`control the flexibility of the rigid portion
`In an exemplary embodiment, the tapered inner catheter
`5 generally includes a tapered inner catheter tip and a cutout
`portion. The tapered inner catheter tip includes a tapered
`portion and a straight portion. The tapered portion is typically
`at the most distal end of the tapered inner catheter. Both the
`straight portion and the tapered portion are pierced by a lumen
`it through which a guidewire may be passed.
`The cutout portion supports a track passing along the con
`cave side thereof that continues from the lumen that passes
`through the straight portion and the tapered portion. The
`tapered inner catheter may also have a clip or snap attachment
`at its proximal end to releasablyjoin the tapered inner catheter
`to the coaxial guide catheter.
`In operation, the tapered inner catheter is inserted inside
`and through the coaxial guide catheter. The tapered inner
`catheter is positioned so that the tapered inner catheter tip
`20 extends beyond the tip portion of the coaxial guide catheter.
`The coaxial guide catheter-tapered inner catheter combina
`tion may then be inserted into a blood vessel that communi
`cates with the aorta. The coaxial guide catheter-tapered inner
`catheter combination may be threaded over a preplaccd 0.014
`inch guidewire. The tapered inner catheter-coaxial guide
`catheter combination is advanced up the aorta until
`the
`tapered inner catheter is passed into the ostium of a coronary
`artery over the guidewire. Once the coaxial guide catheter-
`tapered inner catheter combination has been inserted suffi
`30 ciently into the ostium of the coronary artery to achieve deep
`seating the tapered inner catheter may be removed. During
`this entire process at least part of the coaxial guide catheter-
`tapered inner catheter combination is located inside of the
`guide catheter.
`Once the tapered inner catheter is removed a cardiac treat
`ment device, such as a guidewirc, balloon or stent, may be
`passed through the coaxial guide catheter within the guide
`catheter and into the coronary artery. As described below, the
`presence of the coaxial guide catheter provides additional
`40 backup support to make it less likely that the coaxial guide
`catheter guide catheter combination will be dislodged from
`the ostium of the coronary artery while directing the coronary
`therapeutic device past a tough lesion such as a stenosis or a
`chronic arterial occlusion.
`A guide catheter inserted into the ostium of a branch artery
`where it branches off from a larger artery is subject to force
`vectors that tend to dislodge the distal end of the guide cath
`eter from the ostium of the branch artery when a physician
`attempts to direct a guidewire or other interventional cardi
`50 ology device past an occlusive or stenotic lesion in the branch
`artery. This discussion will refer to a guide wire but it is to be
`understood that similar principles apply to other interven
`tional cardiology devices including balloon catheters and
`stent catheters.
`One of the forces that acts on the guide catheter is an axial
`force substantially along the axis of the branch artery and the
`portion of the guide catheter that is seated in the ostium. This
`force vector is a reactive force created by the pushing back of
`the guide wire against the guide catheter as the physician tries
`60 to force the guidewire through or past the lesion. It tends to
`push the distal end of the catheter out of the ostium in a
`direction parallel to the axis of the branch artery and the axis
`of the distal end of the guide catheter.
`Another of the force vectors that acts on the guide catheter
`is a shearing force that tends to dislodge the distal end of the
`guide catheter from the ostium of the branch artery in a
`direction perpendicular to the axis ofthe branch artery and the
`
`45
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`Page 18 of 21
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`US 8,142,4B B2
`
`5
`axis of the distal end of the guide catheter. This force vector
`arises from curvature of the guide catheter near its distal end
`and the guide wire pushing on the curved portion of the guide
`catheter as the physician applies force to the guidewire. The
`coaxial guide catheter of the preseot
`invention assists in ~
`resisting both the axial forces and the shearing forces that tend
`to dislodge a guide catheter from the ostium of a branch
`artery.
`The system is deliverable using standard techniques utiliz
`ing currently available equipment. The present invention also
`allows atraumatic placement within the coronary artery. Fur
`ther, the invention is deliverable through an existing hemo
`static valve arrangement on a guide catheter without prevent
`ing injections through existing Y adapters. Finally,
`the
`invention has an inner diameter acceptable for delivering
`standard coronary devices after it is placed in the blood yes-
`sel.
`
`10
`
`6
`FIG. 19 is a cross-sectional view of the tapered inner cath
`eter taken along section lines 19-19 of FIG. 18.
`FIG. 20 is a plan view of a coaxial guide catheter in accor
`dance with the present invention.
`FIG. 21 is an elevational view of a coaxial guide catheter in
`accordance with the present invention.
`FIG. 22 is a cross-sectional view taken along section line
`22-22 of FIG. 21.
`
`DETAILED DESCRIPTION OF THE INVENTION
`
`Referring to FIGS. 1 and 2, coaxial guide catheter assem
`bly 10 of the present invention generally includes coaxial
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`20
`
`25
`
`30
`
`35
`
`~ guide catheter 12 and tapered inner catheter 14.
`Coaxial guide catheter 12 generally includes tip portion 16,
`reinforced portion 18, and rigid portion 20. The overall length
`of the coaxial guide catheter typically can be approximately
`125 cm. This length should not be considered limiting.
`Tip portion 16 generally includes bump tip 22 and marker
`band 24. Bump tip 22 includes taper 26. Bump tip 24 is
`relatively flexible and may be fonned, for example, from
`4033 Pebax®. Bump tip 22 may be yellow or another high
`visibility color for ease of handling.
`Marker band 24 is formed of a radiopaque material such as
`platinum/iridium alloy usually at a 90/I 0 ratio. Marker band
`24 may be sandwiched between an outer Pebax® material 28
`and a PTFE liner 30. Outer Pebax® material 28 in this loca
`tion may be formed of 5533 Pebax, for example.
`Reinforced portion 18 includes braid or coil reinforcement
`32. Braid or coil reinforcement 32 may be formed of metal,
`plastic, graphite, or composite structures known to the art.
`Reinforced portion 18 maybe lined on the interior by PTFE
`liner 30 and covered on the exterior by Pebax® material 28.
`Tip portion 16 and reinforced portion 18 together form a
`substantially cylindrical structure. Braid or coil reinforce
`ment 32 may extend approximately 20 to 30 cm.
`In one
`exemplary embodiment, braid or coiled portion has a length
`of approximately 32 to 36 cm.
`Rigid portion 20 may be secured to braid or coil reinforce
`ment by, for example, welding or bonding. Rigid portion 20
`may be formed from a hypotube or a section of stainless steel
`or Nitinol tubing. Other substantially rigid materials may be
`used as well. Rigid portion 20 includes first full circumfer
`ence portion 34, hemicylindrical portion 36, arcuate portion
`38, and second full circumference portion 40.
`First full circumference portion 34 is joined to braid or coil
`reinforcement 32. First full circumference portion 34 extends
`for a relatively short distance, for example, 0.25 cm.
`Hemicylindrical portion 36 desirably includes 40% to 70%
`of the circumference of the tube. Hemicylindrical portion 36
`may extend,
`for example, approximately 20 to 75 cm in
`length.
`Hemicylindrical portion 36 tapers into arcuate portion 38.
`Arcuate portion 38 extends from 25% to 40% of the cir
`cumference of the tube. Arcuate portion 38 may extend lin
`early, for example, for about 15 cm.
`Arcuate portion 38 connects to second full circumference
`portion 40. Second full circumference portion 40 may extend
`for a short distance, for example, approximately 3 cm.
`Tapered inner catheter 14 generally includes tapered inner
`catheter tip 42 and cutout portion 44. Tapered inner catheter
`tip 42 tapers gradually from the diameter ofa guide wire to the
`diameter of tip portion 16.
`Tapered inner catheter tip 42 includes tapered portion 46 at
`a distal end thereot and straight portion 48. Both tapered
`portion 46 and straight portion 48 are pierced by lumen SO.
`
`FIG. 1 is a schematic depiction of the coaxial guide cath
`eter and a tapered inner catheter in accordance with the
`present invention;
`FIG. 2 is schematic depiction of the coaxial guide catheter
`and tapered inner catheter assembled in accordance with the
`present invention;
`FIG. 3 is a plan view of a guide catheter, the coaxial guide
`catheter, and a treatment catheter in accordance with the
`present invention;
`FIG. 4 is a sectiunal view of the coaxial guide catheter in
`accordance with the present invention;
`FIG. 5 is a cross sectional view ofthe coaxial guide catheter
`and tapered inner catheter in accordance with the present
`invention;
`FIG. 6 is another cross sectional view of the coaxial guide
`catheter and tapered inner catheter in accordance with the
`present invention;
`FIG. 7 is a schematic view of a guide catheter and a
`guidewire located in an aortic arch and a coronary artery and 40
`the guide catheter and guidewire in a second position depicted
`in phantom;
`FIG. 8 is a schematic view of a guide catheter, a guidewire,
`a coaxial guide catheter in accordance with the present inven
`tion and a tapered inner catheter located in the aortic arch and 45
`coronary artery;
`FIG. 9 is a schematic view of a guide catheter, a guidewire
`and a coaxial guide catheter in accordance with the present
`invention located in the aortic arch and coronary artery;
`FIG. lOis a flat pattem for making relief cuts in a curved 50
`rigid portion of the coaxial guide catheter in accordance with
`the present invention;
`FIG. 11 is a detailed view taken from FIG. 10;
`FIG. 12 is a plan view of the rigid portion in accordance
`with the present invention;
`FIG. 13 is an elevational view of the rigid portion;
`FIG. 14 is a sectional view of the rigid portion taken along
`section line 14-14 of FIG. 13; and
`FIG. 15 is a sectional view of the rigid portion taken along
`section line 15-15 of FIG. 13.
`FIG. 16 is a sectional view of the rigid portion taken along
`section line 16-16 of FIG. 13.
`FIG. 17 is a plan view of a coaxial guide catheter having a
`longer rail segment and a tapered inner catheter in accordance
`with the present invention.
`FIG. 18 is a plan view of the tapered inner catheter as
`depicted in the FIG. 17.
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`Page 19 of 21
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`US 8,142,413 B2
`
`8
`FIG. 9, the combination of guide catheter 56 with coaxial
`guide catheter 12 inserted into ostisun 60 of coronary artery
`62 provides improved distal anchoring of guide catheter 56
`and coaxial guide catheter 12. The presence of coaxial guide
`catheter 12 within guide catheter 56 also provides stiffer back
`up support than guide catheter 56 alone. The combination of
`improved distal anchoring and stiffening ofthe guide catheter
`56/coaxial guide catheter 12 combination provides additional
`back up support to resist dislodging of guide catheter 56 from
`10 ostium 60 when force is applied to guidewire 64 to pass
`
`5
`
`7
`Cutout portion 44 defines a concave track 52 along its
`length. Concave track 52 is continuous with lumen 50.
`Tapered inner catheter 14 may also include clip 54 at a
`proximal end thereof to releasably join tapered ismer catheter
`14 to coaxial guide catheter 12. Thus, tapered inner catheter
`14 is keyed to coaxial guide catheter 12.
`Coaxial guide catheter 12 may include, starting at its distal
`end, a first portion having a flexural modulus of about 13,000
`PSI plus or minus 5000 PSI, a second portion having a flex
`ural modulus of about 29,000 PSI plus or minus 10,000 PSI,
`a third portion having a flexural modulus of about 49,000 PSI
`plus or minus 10,000 PSI and a fourth portion having a
`flexural modulus of about 107,000 PSI plus or minus 20,000
`PSI. Coaxial guide catheter 12 may be formed, for example,
`of 4033 Pebax® at bump tip 22 for the first 0.1 cm. This
`portion may followed by a section about three cm long of
`5533 Pebax® that covers marker band 24 and the distal por
`tion of braid or coil reinforcement 32. Next may come an
`approximately five cm portion of 6333 Pebax® which
`encloses part of braid or coil reinforcement 32 followed by an
`approximately twenty seven cm portion of 7233 Pebax®
`covering the most proximal portion of braid or coil reinforce
`ment 32. Braid or coil reinforcement 32 is bonded to rigid
`portion 20 which may be fonned from stainless steel or a
`similar biocompatible material. Rigid portion 20 may extend
`for approximately ninety cm and include first fill circumfer
`ence portion 34 (approximately 0.25 cm), hemicylindrical
`portion 36 (approximately seventy five cm), arcuate portion
`(approximately fifteen cm) and second full circumference
`portion (approximately three cm.) Rigid portion 20 may be
`formed from a stainless steel or Nitinol hypo tube.
`FIG. 7 depicts a typical guide catheter 56 passing through
`aortic arch 58 into ostium 60 of coronary artery 62. FIG. 7
`also depicts guidewire 64 passing through the guide catheter
`56 and into coronary artery 62. Loeated in coronary artery 62
`is stenotic lesion 66. In a typical procedure, guidewire 64 is
`placed through the aortic arch 58 and into the ostium 60 ofthe
`coronary artery. 62. The guide catheter 56 is passed over
`guidewire 64 until distal end 68 of guide catheter 56 is seated
`in ostium 60 of coronary artery 62. Force is then appliedto the
`guidewire 64 to push guidewire 64 past stenotic lesion 66 or
`an occlusive lesion (not shown). Once the goidewire 64 is
`pushed past stenotic lesion 66 or occlusive lesion (not
`shown), a treating catheter including a stent or balloon can be
`passed along the guidewire to stenotic lesion 66 or occlusive
`lesion (not shown). The lesion can then be treated.
`As can be seen in phantom, in FIG. 7, the application of
`force to guidewire 64 can cause guide catheter 56 to dislodge
`from ostium 60 of coronary artery 62. This can occur in the
`case of a tough stenotic lesion 66 or occlusive lesion (not
`shown) when it is difficult to pass the guidewire 64 beyond the
`stenotic lesion 66 or occlusive lesion (not shown).
`Referring the FIG. 8 coaxial guide catheter 12 is depicted
`as used with guide catheter 56, guidewire 64, and tapered
`inner catheter 14. 1-lere, coaxial guide catheter 12 with
`tapered inner catheter 14 is passed through guide catheter 56
`and over guidewire 64 into coronary artery 62 after the guide
`catheter 56 has been placed in the ostium 60 of coronary
`artery 62, as depicted in FIG. 7. Coaxial guide catheter 12,
`with tapered inner catheter 14, provide an inner support mem
`ber for proper translation over guidewire 64. Tapered inner
`catheter tip 42 provides a distal
`tapered transition from
`guidewire 64 to coaxial guide catheter 12. Once coaxial guide
`catheter 12 is in place, tapered inner catheter 14 is removed
`from the inside of coaxial guide catheter 12.
`Coaxial guide catheter 12 is now ready to accept a treat
`ment catheter such as a stent or balloon catheter. Referring to
`
`20
`
`25
`
`40
`
`45
`
`~
`
`through stenotic lesion 66 or another lesion. In addition, the
`improved back up support assists in the positioning of a
`treating catheter that may include a stent or balloon.
`Referring to FIGS. 10 and ii, in some embodiments of
`coaxial guide catheter 12, rigid portion 20 may be perforated
`by reliefcuts 70. Relief cuts 70 may be classed into first group
`72 and second group 74.
`First group 72 may be located near to the juncture between
`rigid portion 20 and reinforced portion 18. First group 72 of
`relief cuts 70 are relatively closely spaced. For example, first
`group 72 ofrelief cuts 70 may be spaced approximately 0.0 10
`inches apart. First group 72 of relief cuts 70 extends for a
`relatively short distance,
`for example, approximately 2
`inches.
`Second group 74 of relief cuts 70 may extend for a rela
`tively long distance,
`for example, approximately 30-35
`inches. Second group 74 of relief cuts 70 are spaced farther
`apart than first group 72. For example, reliefcuts 70 of second
`30 group 74 may be spaced approximately 0.020 inches between
`cots. Referring particularly to FIG. 11, relief cuts 70 may
`include single cuts 76 and double cuts 78. Single cuts 76 may
`include an individual
`linear cut, as can be seen in FIG. 11.
`Double cuts 78 may include two linear cuts along a single line
`35 but separated by a short section of uncut structure. Typically,
`single cuts 76 and double cuts 78 are alternated along the
`length of rigid portion 20. Generally, the overall
`length of
`single cot 76 may be less than the overall length of two double
`cuts 78.
`In an embodiment depicted in FIGS. 12-15, rigid portion
`includes fill circumference portion 80, greater than 180°
`portion 82, and less than 180° portion 84. Greater than 180°
`portion 82 may,
`for example,
`include structure fonning
`approximately 300° ofthe circumference ofthe cylinder. Less
`than 180° portion may include, for example, structure form
`ing approximately 90° of the circumference of a cylinder.
`Greater t