Attorney Docket No. 2005.86USREI5
`
`REISSUE APPLICATION TRANSMITTAL
`
`Customer No. 24113
`Patterson Thuente Pedersen, P.A.
`4800 IDS Center
`80 South 8th Street
`Minneapolis, MN 55402
`Telephone: 612.349.5766
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`Mail Stop Reissue
`Commissioner for Patents
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`Commissioner:
`
`Transmitted herewith for filing under 37 CFR. § 1.171 is the continuation reissue patent application of U.S.
`Patent No. 8,292,850 B2
`
`INVENTOR(S): Howard C. Root, Gregg Sutton, Jeffrey M. Welch and Jason M. Garrity
`
`FOR: COAXIAL GUIDE CATHETER FOR INTERVENTION AL CARDIOLOGY PROCEDURES
`Enclosed are:
`
`[X]
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`[X]
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`[ ]
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`[ ]
`
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`[X]
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`[ ]
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`[X]
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`[X]
`
`Specification and Abstract - 7 pages (from issued patent)
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`Drawings - 13 sheets (Figs. 1-22), copies of drawings from issued patent
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`Reissue Application Declaration and Power of Attorney
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`Statement Under 37 CFR. 3.73(b)
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`Copy of U.S. Patent No. 8,292,850 82
`
`Other Application Data Sheet
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`The filing fee has been calculated as shown below:
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`Page 1
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`Medtronic Exhibit 1003
`
`

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`For arm.'.ndil1::rH~ !ikd prior io 1)1;.',. 8. 2004, ,'nl:.:r th.: !·,igh.:r of lht: Nurni>,~r !'r,",·!<.n1s!y Paid or Nmnb,'r of [ndrp.:ncknl C!;:im, in
`Pati:nt.
`
`IX]
`
`Applicants arc ;:ntiOcd io small entity status in accordance with 37 CFR 1.27.
`
`Electronic payment is submitted by cn;'.dit card to cover the filing lee. The Commissioner is hereby
`authorized to grant any extensions of time and to charge any fees under 37 CFR §§ J. ! 6 and 1.17 that
`may be required during the (•ntire pcndcnc:y of this application to Deposit Account No, l 6-0631.
`
`Re._jpc.qtfu 1 ly submitted,
`_.,../
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`, ,J ... ~:>-c::~:~.--·-·k:~~-·--_\~--=.-::~~----------··
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`Paul C. Onderick
`Registration No. 453 54
`
`Page 2
`
`Medtronic Exhibit 1003
`
`

`

`I IIIII IIIIIIII Ill lllll lllll lllll lllll lllll lllll lllll lllll llllll llll llll llll
`
`US00829285082
`
`c12) United States Patent
`Root et al.
`
`(IO) Patent No.:
`(45) Date of Patent:
`
`US 8,292,850 B2
`Oct. 23, 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 O days.
`
`(21) Appl. No.: 13/359,059
`
`(22) Filed:
`
`Jan. 26, 2012
`
`(65)
`
`Prior Publication Data
`
`US 2012/0I65756AI
`
`Jun.28,2012
`
`Related U.S. Application Data
`
`(62) Division of application No. 12/824,734, filed on Jun.
`28, 2010, now Pat. No. 8,142.413, which is a division
`of application No. 11/416.629, filed on May 3. 2006,
`now Pat. No. 8,048,032.
`
`(51)
`
`Int.CI.
`(2006.01)
`A61M5!178
`(2006.01)
`A61M 25100
`(52) U.S. Cl .
`................................... 604/164.01; 604/525
`(58) Field of Classification Search ............. 604/103.04,
`604/103.09, 160-162, 164.01, 164.02, 164.09-164.11,
`604/525
`See application file for complete search history.
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`311989 Elliott
`4,813,930 A
`5/1989 Palel
`4,832,028 A
`6/1990 Shockey el al.
`4,932,413 A
`3/1992 Shiu
`5,098,412 A
`6/1992 Deuss
`5,122,125 A
`12/1995 Teirslein
`5,472,425 A
`8/1997 Dangel al.
`5,658,263 A
`7/1998 Klein et al.
`5,776,141 A
`12/2000 Haelal.
`6,159,195 A
`1/2002 Hermann el al.
`6,338,725 Bl
`11/2002 Voda
`6,475,195 Bl
`7/2003 Forsberg
`6,595,952 B2
`8/2003 Yang
`6,610,068 Bl
`10/2003 Niazi
`6,638,268 B2
`2/2004 Gerberding
`6,689,144 B2
`312004 Westlund et al.
`6,706,018 B2
`612004 Pelerson et al.
`6,755,812 B2
`(Continued)
`OTHER PUBLICATIONS
`Saeko Takahashi el al.; New Method lo Increase a Backup Support of
`a 6 French Guiding Coronary Catheler; Catheterization and Cardio(cid:173)
`vascular Inteiventions 63:452-456 (2004), 5 pages; Published online
`in Wiley InterScience (www.interscience.wiley.com).
`
`(Continued)
`Primary Examiner - Kevin C Sirmons
`Assistant Examiner - Bradley Osinski
`(74) Attorney, Agent, or Firm - Patterson Thuente
`Christensen Pedersen, P.A.
`ABSTRACT
`(57)
`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.
`
`24 Claims, 13 Drawing Sheets
`
`;r
`~
`
`/"10
`
`127
`
`/10
`( (
`
`14:J
`
`1~J
`{o~
`
`~~o
`
`r-12
`
`48:::)
`
`18)
`
`16
`
`{f:
`rr~
`4;)
`
`Page 3
`
`Medtronic Exhibit 1003
`
`

`

`US 8,292,850 B2
`Page 2
`
`U.S. PATENT DOCUMENTS
`6,860,876 B2
`3/2005 Chen
`7,697,996 B2
`4/20 IO Manning ct al.
`5/20 IO Bowe ct al.
`7,717,899 B2
`10/2003 Solar ct al.
`2003/0195546 Al
`7/2004 Adams
`2004/0127927 Al
`2005/0004523 Al
`1/2005 Osborne ct al.
`
`2005/0182437 Al
`2007/0260219 Al
`
`8/2005 Bonnette et al.
`11/2007 Root et al.
`
`OTHER PUBLICATIONS
`
`U.S. Appl. No. 11/416,629, filed Jun. 28, 2010; Howard Root et al.
`U.S. Appl. No. 12/824,734, filed Jun. 28, 2010, Howard Root ct al.
`
`Page 4
`
`Medtronic Exhibit 1003
`
`

`

`US 8,292,850 B2
`
`1
`COAXIAL GUIDE CATHETER FOR
`INTERVENTIONAL CARDIOLOGY
`PROCEDURES
`
`RELATED APPLICATIONS
`
`5
`
`2
`the guide catheter may occlude the coronary artery and inter(cid:173)
`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
`backup support or the appendage may be placed under ten(cid:173)
`sion to stiffen a bend in the catheter to provide backup sup(cid:173)
`port. Examples of this approach may be found in U.S. Pat. No.
`4,813,930 issued to Elliot; U.S. Pat. No. 5,098.412 issued to
`Shiu; and U.S. Pat. No. 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 ostium of the
`15 coronary artery to provide a force acting in opposition to the
`backward forces created when trying to maneuver a therapeu(cid:173)
`tic device past a lesion or blockage in the coronary artery.
`These devices can include a balloon secured to a guidewire or
`a catheter or another device for expanding to grip the walls of
`20 the coronary artery from within. Examples of this approach
`may be found in lJ .S. Pat. No. 4,832,028 issued to Patel; U.S.
`Pat. No. 6,595,952 issued to Forsberg; and U.S. Published
`Application No. 2005/0182437 by Bonnette et al. Again,
`these devices tend to be mechanically complex and can com-
`25 pletely 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(cid:173)
`vide added support for the crossing of lesions or for the distal
`30 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
`Interventions, 63:452-456 (2004). This technique is used in
`35 order to provide a method of deep seating the guide catheter
`within the ostium 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(cid:173)
`tunately, deep seating by this technique with a commonly
`40 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
`45 catheter in this catheter-in-a-catheter fashion. First, the inner
`catheters must be substantially longer than the one hundred
`centimeter guide catheter. Second, a new hemostasis valve
`must be placed on the inner guide catheter which prevents the
`larger guide catheter from being used for contrast injections
`50 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 run over a standard 0.014 inch
`guidewire.
`Thus, the interventional cardiology art would benefit from
`the availability of a system that would be deliverable through
`standard guide catheters for providing backup support by
`providing the ability to effectively create deep seating in the
`ostium of the coronary artery.
`
`This application is a divisional of application Ser. No.
`12/824, 734, filed Jun. 28, 2010 now U.S. Pat. No. 8, 142,413
`entitled "Coaxial Guide Catheter for lnterventional Cardiol-
`ogy Procedures", which is divisional of application Ser. No. 10
`11/416,629, filed May 3, 2006 now U.S. Pat. No. 8,048,032
`entitled "Coaxial Guide Catheter for Interventional Cardiol-
`ogy Procedures".
`
`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(cid:173)
`nary arteries from the aorta.
`
`BACKGROUND OF THE INVENTION
`
`Interventional cardiology procedures often include insert(cid:173)
`ing guidewires or other instruments through catheters into
`coronary arteries that branch off from the aorta. For the pur(cid:173)
`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(cid:173)
`rowed oroccluded by atherosclerotic plaques orother 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 guidewire or other instnunents 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 o fthe 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
`Yoda and U.S. Pat. No. 5,658,263 issued to Dang et al. These 60
`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 causing damage to the aortic wall. In addition.
`attempts to deep seat the guide catheter have been made but 65
`the rigid nature of the guide catheter creates the risk that the
`guide catheter may damage the coronary artery wall or that
`
`55
`
`SUMMARY OF THE INVENTION
`
`The present invention is a coaxial guide catheter that is
`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(cid:173)
`ably includes a tapered inner catheter that runs over a standard
`
`Page 5
`
`Medtronic Exhibit 1003
`
`

`

`us 8,292,850 82
`
`3
`4
`removed may extend for approximately 7 5 cm and the portion
`0.014 inch coronary guidewire to allow atraumatic placement
`within the coronary artery. This feature also allows removal of
`having 75-90"A, of the structure removed extends for about 15
`cm.
`the tapered inner catheter after the coaxial guide catheter is in
`The full circumference portion of the rigid portion is typi-
`place. The tapered inner catheter provides a gradual transition
`from the standard 0.014 inch diameter guidewire to the diam-
`5 cally located at lhe most proximal end of the coaxial guide
`eter of the coaxial guide catheter which is typically five to
`catheter.
`The rigid portion may include a plurality of radially ori-
`eight French.
`enled slits or other cuts in its distal portion to increase and
`The coaxial guide catheter preferably can be delivered
`control the flexibility of the rigid portion
`through commonly existing hemostatic valves used with
`In an exemplary embodiment, the tapered inner catheter
`guide catheters while still allowing injections through the 10
`existing y adapter. In addition. the coaxial guide catheter
`generally includes a lapercd inner catheler lip and a cutout
`Portion. The tapered inner catl1eter lip includes a tapered
`preferably has an inner diameter that is appropriate for deliv-
`portion and a stmight portion. The tapered portion is typically
`at the most distal end of the tapered inner catheter. Both the
`ering standard coronary treatment devices after it is placed in
`the coronary artery.
`1 s straight portion and the tapered portion are pierced by a lumen
`through which a guidewire may be passed.
`In one embodiment, the coaxial guide catheter is made in at
`least three sizes corresponding to the internal capacity of 8
`The cutout portion supports a tmck passing along the con-
`cave side thereof that continues from the lumen that passes
`French, 7 French, and 6 French guide catheters that are com-
`through the straight portion and the tapered portion. The
`monly used in interventional cardiology procedures. An 8
`French catheter has an internal diameter greater than or equal 20 tapered inner catheler may also have a clip or snap attachment
`to 0.088 inches. A 7 French catheter has an internal diameter
`at its proximal end to releasably join the tapered inner catheter
`greater than or equal to 0.078 inches. A 6 French guide cath-
`to the coaxial guide catheter.
`eter has an internal diameter greater than or equal to 0.070
`In operation, lhe tapered inner catheter is inserted inside
`inches. Thus, for three exemplary sizes the effective internal
`and through the coaxial guide catheter. The tapered inner
`diameter of the coaxial guide catheter may be as follows. For 25 catheter is positioned so that the tapered inner catheter tip
`extends beyond the tip portion of the coaxial guide catheter.
`a 7 French in 8 French coaxial guide catheter, the internal
`diameter should be greater than or equal to 0.078 inches. For
`The coaxial guide catheler-lapered inner catheter combina-
`a 6 French in 7 French coaxial guide catheter the internal
`tion may then be inserted into a blood vessel that communi-
`diameter should be greater than or equal to 0.070 inches. For
`cat es with the aorta. The coaxial guide catheter-tapered inner
`a 5 French in 6 French coaxial guide catheter the internal 30 catheter combination may be threaded over a prep laced 0.014
`inch guidewire. The tapered inner catheter-coaxial guide
`diameter should be greater lhan or equal to 0.056 inches.
`lnterventional cardiology procedures are typically carried
`catheter combination is advanced up the aorta until the
`out under fluoroscopy or another x-ray or imaging technique.
`tapered inner calheter is passed into the ostium of a coronary
`Therefore, one embodiment of the coaxial guide catheter of
`artery over the guidewire. Once the coaxial guide catheter-
`the presenl invenlion includes a radiopaque marker at its 35 tapered inner catheter combination has been inserted suffi-
`distal tip lo facilitate positioning and manipulation of the
`ciently into lhe ostium of the coronary artery to achieve deep
`coaxial guide calheter.
`seating the tapered inner catheter may be removed. During
`this entire process at leasl part of the coaxial guide catheter-
`The presenl invention generally includes the coaxial guide
`tapen .. -d inner catheter combination is located inside of the
`catheler and a lapered inner catheter. The coaxial guide cath-
`eter includes a lip portion, a reinforced portion, and a sub- 40 guide catheter.
`stantially rigid portion. lbc coaxial guide catheter will gen-
`Once lhe tapered inner catheter is removed a cardiac treat-
`erally have an overall length of preferably approximately 125
`mcnt device, such as ii guidewirc. balloon or stent, may be
`cm, though this should nol be considered limiting.
`passed lhrough the couxial guide cutheter within the guide
`In one embodiment, the tip portion may include a soft tip
`catheter and inlo the coronary artery. As described below, the
`and a marker band. The soft tip is tapered and may be formed 45 presence of the coaxial guide catheter provides additional
`backup support to make ii less likely that the coaxial guide
`from a low durometer polymer or elastomer material such as
`polyether block amide polymer, (PEBA, Pebax®) the marker
`calheter guide catheter combination will be dislodged from
`the ostium ofthe coronary artery while directing the coronary
`band may be fom1cd from a platinum iridium alloy sand-
`therapeutic device past a tough lesion such as a stenosis or a
`wiched between the Pebax® that extends from the bump tip
`and a PTFE liner.
`50 chronic arterial occlusion.
`In one embodiment, the reinforced portion may be rein-
`A guide calheter inserted into the ostium of a branch artery
`forced, preferably with metallic fibers in a braided or coiled
`where it branches off from a larger artery is subject to force
`pattern. The braided or coiled portion is I ined by a PTFE liner
`vectors that tend to dislodge the distal end of the guide cath-
`and may be covered on its exterior with Pebax®. The braided
`eter from the ostium of the branch artery when a physician
`or coiled portion may extend approximately 20 to I IO cm in 55 attempts to direct a guidewire or other interventional cardi-
`ology device past an occlusive or steno tic lesion in the branch
`length. In one exemplary embodiment, the braided portion
`ex lends approximately 32 to 36 cm.
`artery. This discussion will refer to a guide wire but it is to be
`Preferably, the rigid portion may be advantageously
`understood that similar principles apply to other interven-
`formed from a stainless steel or Nitinol n1be. The rigid portion
`tional cardiology devices including balloon catheters and
`may be joined to the braid or coil portion by welding. The 60 stent catheters.
`rigid portion may include a cutout portion and a full circum-
`One of the forces that act on the guide catheter is an axial
`ference portion. For example, the cutout portion may include
`force substantially along the axis of the branch artery and the
`a section where about 45% of the circumference of the cylin-
`portion of the guide catheter that is seated in the ostium. This
`drical tubular structure has been removed. The cutout portion
`force vector is a reactive force created by the pushing back of
`may also include a section where 75-90% of the circumfer- 65 the guide wire against the guide catheter as the physician tries
`to force the guidewire through or past the lesion. It tends to
`ence of the tubular structure has been removed. In one exem-
`plary embodiment, the portion having approximately 45%
`push the distal end of the catheter out of the ostium in a
`
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`Medtronic Exhibit 1003
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`

`us 8,292,850 82
`
`6
`FIG. 17 is a plan view ofa 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.
`FIG. 19 is a cross-sectional view of the tapered inner cath(cid:173)
`eter taken along section lines 19-19 of FIG. 18.
`FIG. 20 is a plan view of a coaxial guide catheter in accor(cid:173)
`dance with the present invention.
`FIG. 21 is an elevational view ofa coaxial guide catheter in
`accordance with the present invention.
`FIG. 22 is a cross-sectional view taken along section line
`22-22 ofFIG. 21.
`
`DETAILED DESCRIPTION OF THE DRAWINGS
`
`5
`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 bmnch artery in a
`direction perpendicular to the axis of the branch artery and the
`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 present 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(cid:173)
`ther, the invention is deliverable through an existing hemo(cid:173)
`static valve arrangement on a guide catheter without prevent(cid:173)
`ing injections tlmrngh existing Y adapters. Finally, the 20
`invention has an inner diameter acceptable for delivering
`standard coronary devices after it is placed in the blood ves(cid:173)
`sel.
`
`10
`
`t 5
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`25
`
`Referring to FIGS. 1 and 2, coaxial guide catheter assem(cid:173)
`bly IO of the present invention generally includes coaxial
`guide catheKT 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 formed, 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 90/10 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(cid:173)
`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 may be lined on the interior by PTFE
`40 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(cid:173)
`ment 32 may extend approximately 20 to 30 cm. In one
`exemplary embodiment, braid or coiled portion has a length
`45 of approximately 32 to 36 cm.
`Rigid portion 20 may be secured to braid or coil reinforce(cid:173)
`ment by, for example, welding or bonding. Rigid portion 20
`may be fom1ed from a hypotube or a section of stainless steel
`or Nitinol tubing. Other substantially rigid materials may be
`50 used as well. Rigid portion 20 includes first full circumfer(cid:173)
`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 foll circumference portion 34 extends
`55 for a relatively short distance, for example, 0.25 cm.
`Hemicylindrical portion 36 desimbly includes 40% to 70%
`of the circumference of the tube. Hemicylindrical portion 36
`may extend, for example, approximately 20 to 75 cm in
`60 length.
`Hemicylindrical portion 36 tapers into arcuate portion 38.
`Arcuate portion 38 extends from 25% to 40% of the cir(cid:173)
`cumference of the tube. Arcuate portion 38 may extend lin(cid:173)
`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.
`
`35
`
`FIG. 1 is a schematic depiction of the coaxial guide cath(cid:173)
`eter and a tapered inner catheter in accordance with the
`present invention;
`FIG. 2 is schematic depiction of the coaxial guide catheter 30
`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 sectional view of the coaxial guide catheter in
`accordance with the present invention;
`FIG. 5 is a cross sectional view of the 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
`the guide catheter and guidewire in a second position depicted
`in phantom;
`FIG. 8 is a schematic view ofa guide catheter. aguidewire,
`a coaxial guide catheter in accordance with the present inven(cid:173)
`tion and a tapered inner catheter located in the aortic arch and
`coronary artery;
`FIG. 9 is a schematic view ofa guide catheter. a guidewire
`and a coaxial guide catheter in accordance with the present
`invention located in the aortic arch and coronary artery;
`FIG. 10 is a flat pattern for making relief cuts in a curved
`rigid portion of the coaxial guide catheter in accordance with
`the present invention;
`FIG. 11 is a detailed view taken from FIG. IO;
`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.
`
`65
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`us 8,292,850 82
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`7
`Tapered inner catheter 14 generally includes tapered inner
`catheter tip 42 and cutout portion 44. Tapered inner catheter
`tip 42 tapers gradually from the diameterofa guide wire to the
`diameteroftip portion 16.
`Tapered inner catheter tip 42 includes tapered portion 46 at 5
`a distal end thereof, and straight portion 48. Both tapered
`portion 46 and straight portion 48 are pierced by lumen 50.
`Cutout portion 44 defines a concave track 52 along its
`length. Concave tmck 52 is continuous with lumen 50.
`lapered inner catheter 14 may also include clip 54 at a 10
`proximal end thereof to rcleasably join tapered inner catheter
`14 10 coaxial guide catheter 12. Thus. tapered inner catheter
`14 is keyed to coaxial guide catheter 12.
`Coaxial guide catheter 12 may include, starting al its distal
`end, a first portion having a flexural modulus of about 13,000 15
`PSI plus or minus 5000 PSI, a second portion having a flex(cid:173)
`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 20
`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(cid:173)
`tion of braid or coil reinforcement 32. Next may come an 25
`approximately five cm portion of 6333 Pebax® which
`encloses part ofbraid or coil reinforcement 32 followed by an
`approximately twenty seven cm portion of 7233 PebaxcJi.1
`covering the most proximal portion of braid or coil reinforce(cid:173)
`ment 32. Braid or coil reinforcement 32 is bonded to rigid 30
`portion 20 which may be formed from stainless steel or a
`similar biocompatible material. Rigid portion 20 may extend
`for approximately ninety cm and include first full circumfer(cid:173)
`ence portion 34 (approximately 0.25 cm). hemicylindrical
`portion 36 (approximately seventy five cm), arcuate portion 35
`(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