(19) United States
`(12) Reissued Patent
`R00t et al.
`
`USOORE45776E
`
`US RE45,776 E
`(10) Patent Number:
`(45) Date of Reissued Patent:
`*Oct. 27, 2015
`
`(54) COAXIAL GUIDE CATHETER FOR
`INTERVENTIONAL CARDOLOGY
`PROCEDURES
`
`(71) Applicant: VASCULAR SOLUTIONS, INC.,
`Minneapolis, MN (US)
`(72) Inventors: Howard C. Root, Tonka Bay, MN (US);
`Gregg Sutton, Plymouth, MN (US);
`Jeffrey M. Welch, Maple Grove, MN
`(US); Jason M. Garrity, Lima, NY (US)
`(73) Assignee: Vascular Solutions, Inc., Minneapolis,
`MN (US)
`This patent is subject to a terminal dis
`claimer.
`(21) Appl. No.: 14/195,413
`(22) Filed:
`Mar. 3, 2014
`Related U.S. Patent Documents
`
`(*) Notice:
`
`8,292,850
`Oct. 23, 2012
`13/359,059
`Jan. 26, 2012
`
`Reissue of:
`(64) Patent No.:
`Issued:
`Appl. No.:
`Filed:
`U.S. Applications:
`(60) Continuation of application No. 14/070,161, filed on
`Nov. 1, 2013, now Pat. No. Re. 45,380, which is an
`application for the reissue of Pat. No. 8,292.850, which
`is a 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. 1 1/416,629, filed on May 3,
`2006, now Pat. No. 8,048,032.
`
`(51) Int. Cl.
`A6M5/78
`A6M 25/00
`A6M25/06
`(52) U.S. Cl.
`CPC ....... A61M 25/0026 (2013.01); A61M 25/0052
`(2013.01); A61M 25/0662 (2013.01)
`
`(2006.01)
`(2006.01)
`(2006.01)
`
`(58) Field of Classification Search
`CPC ..................... A61M 25/0026; A61M 25/0052;
`A61M25/0662
`USPC .......... 604/103.04, 103.09, 160-162, 164.01,
`604/164.02, 164.09-164.11, 525
`See application file for complete search history.
`References Cited
`
`(56)
`
`U.S. PATENT DOCUMENTS
`
`4,289,128 A
`4,723.936 A
`
`9, 1981 Rish
`2f1988 Buchbinder et al.
`(Continued)
`
`FOREIGN PATENT DOCUMENTS
`
`EP
`EP
`EP
`WO
`
`1, 1988
`O313558
`5, 1990
`O365993
`8, 1990
`O38O873
`9, 1984
`WO84,03633
`OTHER PUBLICATIONS
`
`Saeko Takahashi, et al., “New Method to Increase a Backup Support
`Of A 6 French Guiding Coronary Catheter'. Catheterization and
`Cardiovascular Interventions, 63:452-456 (2004), 5 Pages; Pub
`lished online in Wiley InterScience (www.interscience.wiley.com).
`(Continued)
`
`Primary Examiner — Bhisma Mehta
`Assistant Examiner — Bradley Osinski
`(74) Attorney, Agent, or Firm — Patterson Thuente
`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.
`33 Claims, 13 Drawing Sheets
`
`
`
`Page 1
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`

`

`US RE45,776 E
`Page 2
`
`Related U.S. Application Data
`U.S. PATENT DOCUMENTS
`
`8, 1988 Bonzel
`4,762,129 A
`3, 1989 Elliott
`4,813,930 A
`5, 1989 Patel
`4,832,028 A
`3/1990 Goldberger
`4.909,252 A
`6/1990 Shockey et al.
`4,932,413 A
`8, 1990 Hall
`4.946,440 A
`2f1991 Mizuta
`4,994,745 A
`3, 1991 Bonzel
`5,002,531 A
`3, 1992 Shiu
`5,098.412 A
`4, 1992 Alt
`5,102.403 A
`6, 1992 DeuSS
`5, 122,125 A
`8, 1993 Bonzel
`5,232.445 A
`8/1993 Macaulay et al.
`5,234,416 A
`5,257,974 A 11, 1993 COX
`5,328,472 A
`7, 1994 Steinke et al.
`5,368,567 A 11/1994 Lee
`5,441489 A
`8, 1995 Utsumi et al.
`5,445,624 A
`8, 1995 Jimenez
`5,472,425 A 12/1995 Teirstein
`5,527,292 A
`6, 1996 Adams et al.
`5,549,553 A
`8, 1996 Ressemann et al.
`5,599,326 A
`2, 1997 Carter
`5,658.263 A
`8/1997 Dang et al.
`5,690,613 A 11/1997 Verbeek
`5,776,141 A
`7, 1998 Klein et al.
`5,792,124 A
`8/1998 Horrigan et al.
`5,911,715 A
`6/1999 Berg et al.
`5,980,486 A 1 1/1999 Enger
`6,159,195 A 12/2000 Ha et al.
`6,193,686 B1
`2, 2001 Estrada et al.
`6,338,725 B1
`1/2002 Hermann et al.
`6,409,863 B1
`6, 2002 Williams et al.
`6,475,195 B1 1 1/2002 Voda
`6,488,655 B1
`12/2002 Wantink et al.
`6,503.223 B1
`1/2003 Sekido et al.
`6,503,353 B1
`1/2003 Peterson et al.
`6,548,010 B1
`4/2003 Stivland et al.
`6,575,958 B1
`6/2003 Happ et al.
`6,591,472 B1
`7/2003 Noone et al.
`6,595,952 B2
`7/2003 Forsberg
`6,610,068 B1
`8/2003 Yang
`6,635,029 B1
`10/2003 Venturelli
`6,638,268 B2 10/2003 Niazi
`6,689,144 B2
`2/2004 Gerberding
`6,706,018 B2
`3, 2004 Westlund et al.
`6,755,812 B2
`6, 2004 Peterson et al.
`6,860,876 B2
`3, 2005 Chen
`7,232,452 B2
`6, 2007 Adams et al.
`7,294,124 B2 11/2007 Eidenschink
`7,544,201 B2
`6/2009 Pepper
`7,697.996 B2
`4/2010 Manning et al.
`7,717,899 B2
`5, 2010 Bowe et al.
`7,762.984 B2
`7/2010 Kumoyama et al.
`8,048,032 B2 11/2011 Root et al.
`8,142,413 B2
`3/2012 Root et al.
`8,292,850 B2 10/2012 Root et al.
`2003. O195546 A1
`10/2003 Solar et al.
`2004/O127927 A1
`7/2004 Adams
`2005, 0004523 A1
`1/2005 Osborne et al.
`2005, 0182437 A1
`8, 2005 Bonnette et al.
`2007/0260219 A1
`11/2007 Root et al.
`
`OTHER PUBLICATIONS
`
`Complaint, Jury Trial Demanded, Dated May 15, 2013, Filed in
`District Court Case 0:13-cv-01 172 (JRT-SER), Vascular Solutions,
`Inc., v. Boston Scientific Corporation, 18 Pgs.
`Amended Complaint, Jury Trial Demanded, Dated May 28, 2013,
`Filed in District Court Case 0:13-cv-01 172 (JRT-SER), Vascular
`Solutions, Inc., v. Boston Scientific Corporation, 20 Pgs.
`
`Plaintiffs Memorandum in Support of Motion for Preliminary
`Injunction, dated Jun. 10, 2013, Filed in District Court Case 0:13-cv
`01 172 (JRT-SER), Vascular Solutions, Inc., v. Boston Scientific Cor
`poration, 40 Pgs.
`Declaration of Howard Root in Support of Plaintiffs Motion for
`Preliminary Injunction, Dated Jun. 10, 2013, Filed in District Court
`Case 0:13-cv-01 172 (JRT-SER), Vascular Solutions, Inc., v. Boston
`Scientific Corporation, 55 Pgs.
`Declaration of Anthony C. Vrba, Dated Jul. 8, 2013, Filed in District
`Court Case 0:13-cv-01 172 (JRT-SER), Vascular Solutions, Inc., v.
`Boston Scientific Corporation, 4 Pgs.
`Declaration of Tony J. Demartini, M.D., Dated Jul. 8, 2013, Filed in
`District Court Case 0:13-cv-01 172 (JRT-SER), Vascular Solutions,
`Inc., v. Boston Scientific Corporation, 3 Pgs.
`Placeholder for Declaration of Sam Rasmusen, Dated Jul. 8, 2013,
`Filed in District Court Case 0:13-cv-01 172 (JRT-SER), Vascular
`Solutions, Inc., v. Boston Scientific Corporation, 1 Pg.
`Boston Scientific Corporation's Answer to Amended Complaint and
`Counterclaims, Dated Jul. 11, 2013, Filed in District Court Case
`0:13-cv-01 172 (JRT-SER), Vascular Solutions, Inc., v. Boston Scien
`tific Corporation, 22 Pgs.
`Plaintiffs Reply Memorandum in Support of Motion for Preliminary
`Injunction ***Redacted, Filed Jul. 24, 2013, Filed in District
`Court Case 0:13-cv-01 172 (JRT-SER), Vascular Solutions, Inc., v.
`Boston Scientific Corporation, 27 Pgs.
`Second Declaration of Howard Root in Support of Plaintiffs Motion
`for Preliminary Injunction, Dated Jul. 24, 2013, Filed in District
`Court Case 0:13-cv-01 172 (JRT-SER), Vascular Solutions, Inc., v.
`Boston Scientific Corporation, 22 Pgs.
`Defendant, Boston Scientific Corporation's Prior Art Statement,
`Dated Dec. 20, 2013, cited in Civil No. 0:13-cv-01 172-JRT-SER.
`Defendant, Boston Scientific Corporation's First Amended Prior Art
`Statement, Dated Apr. 25, 2014, cited in Civil No. 0:13-cv-01 172
`JRT-SER
`Plaintiff, Vascular Solutions, Inc.'s Response to Defendant Boston
`Scientific Corporation's Prior Art Statement, Dated Jan. 23, 2014,
`Civil No. 0:13-cv-01 172-JRT-SER.
`Plaintiff, Vascular Solutions, Inc.'s Response to Defendant Boston
`Scientific Corporation's First Amended Prior Art Statement, Dated
`Jul. 1, 2014, Civil No. 0:13-cv-01 172-JRT-SER.
`Judgment and Order Granting Termination of Proceedings, Paper 10,
`Entered Aug. 11, 2014, in Case No. IPR2014-00759; Case No.
`IPR2014-00760; Case No. IPR2014-00761; Case No. IPR2014
`00762; and Case No. IPR2014-00763.
`Joint Motion to Terminate Filed Aug. 8, 2014, in Case No. IPR2014
`OO759.
`Joint Motion to Terminate Filed Aug. 8, 2014, in Case No. IPR2014
`OOT60.
`Joint Motion to Terminate Filed Aug. 8, 2014, in Case No. IPR2014
`OOT61.
`Joint Motion to Terminate Filed Aug. 8, 2014, in Case No. IPR2014
`OOT62.
`Joint Motion to Terminate Filed Aug. 8, 2014, in Case No. IPR2014
`OOT63.
`Joint Request to File Settlement Agreement as Business Confidential
`Information, Filed Aug. 8, 2014, in Case No. IPR2014-00759.
`Joint Request to File Settlement Agreement as Business Confidential
`Information, Filed Aug. 8, 2014, in Case No. IPR2014-00760.
`Joint Request to File Settlement Agreement as Business Confidential
`Information, Filed Aug. 8, 2014, in Case No. IPR2014-00761.
`Joint Request to File Settlement Agreement as Business Confidential
`Information, Filed Aug. 8, 2014, in Case No. IPR2014-00762.
`Joint Request to File Settlement Agreement as Business Confidential
`Information, Filed Aug. 8, 2014, in Case No. IPR2014-00763.
`U.S. Appl. No. 1 1/416,629, filed Jun. 28, 2010; Howard Root et al.
`U.S. Appl. No. 12/824,734, filed Jun. 28, 2010, Howard Root et al.
`
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`US RE45,776 E
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`1.
`COAXAL GUIDE CATHETER FOR
`INTERVENTIONAL CARDOLOGY
`PROCEDURES
`
`appears in the
`Matter enclosed in heavy brackets
`original patent but forms no part of this reissue specifica
`tion; matter printed in italics indicates the additions
`made by reissue; a claim printed with strikethrough indi
`cates that the claim was canceled, disclaimed, or held
`invalid by a prior post-patent action or proceeding.
`
`RELATED APPLICATIONS
`
`5
`
`10
`
`15
`
`This application is a reissue of application Ser: No. 13/359,
`059 filed Jan. 26, 2012 which issued as U.S. Pat. No. 8,292,
`850 entitled "Coaxial Guide Catheter for Interventional Car
`diology Procedures' and a continuation of application Ser:
`No. 14/070, 161 which is an application for reissue of U.S.
`Pat. No. 8,292,850 which is entitled “Coaxial Guide Catheter
`for Interventional Cardiology Procedures a divisional of
`application Ser. No. 12/824,734, filed Jun. 28, 2010 entitled
`“Coaxial Guide Catheter for Interventional Cardiology Pro
`cedures' now U.S. Pat. No. 8, 142,413, which is divisional of
`application Ser. No. 1 1/416,629, filed May 3, 2006 now U.S.
`Pat. No. 8,048,032 entitled “Coaxial Guide Catheterfor Inter
`ventional Cardiology Procedures'. Notice: more than one
`reissue application has been filed for the reissue of U.S. Pat.
`No. 8,292,850; the reissue applications are application Ser:
`No. 14/070, 161, this application and continuation reissue
`application Ser: Nos. 14/195.385 and 14/195,435 filed Mar. 3,
`2014, the same day as this application.
`
`25
`
`30
`
`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 guidewires 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 guidewire 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.
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`2
`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 issued to Dang 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 causing 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
`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. 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
`coronary artery to provide a force acting in opposition to the
`backward forces created when trying to maneuver atherapeu
`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
`the coronary artery from within. Examples of this approach
`may be found in U.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
`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
`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
`Interventions, 63:452-456 (2004). This technique is used in
`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
`tunately, 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 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
`
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`US RE45,776 E
`
`3
`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 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.
`
`SUMMARY OF THE INVENTION
`
`4
`band may be formed from a platinum iridium alloy sand
`wiched between the Pebax(R) 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(R). The braided
`or coiled portion may extend approximately 20 to 110 cm 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 or Nitinol 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
`C.
`The full circumference portion of the rigid portion is typi
`cally located at the most proximal end of the coaxial guide
`catheter.
`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
`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 alumen
`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 releasably join 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
`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 preplaced 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
`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 guidewire. 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
`backup support to make it less likely that the coaxial guide
`catheter guide catheter combination will be dislodged from
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`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
`ably includes a tapered inner catheter that runs overa standard
`0.014 inch coronary guidewire to allow atraumatic placement
`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
`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 can 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 embodiment, 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 com
`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 0.078 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 may be 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 0.056 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
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`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 marker band. The soft tip is tapered and may be formed
`from a low durometer polymer or elastomer material Such as
`polyether block amide polymer, (PEBA, Pebax(R) the marker
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`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.
`Aguide catheter inserted into the ostium of a branchartery
`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
`ology device past an occlusive or Stenoticlesion 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 act on the guide catheter is an axial
`force substantially along the axis of the branchartery 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
`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 of the branchartery 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
`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 ves
`sel.
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`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
`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. 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. 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.
`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 DRAWINGS
`
`Referring to FIGS. 1 and 2, coaxial guide catheter assem
`bly 10 of the present invention generally includes coaxial
`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 formed, for example, from
`4033 Pebax(R). 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(R) material 28
`and a PTFE liner 30. Outer Pebax(R) 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 may be lined on the interior by PTFE
`liner 30 and covered on the exterior by Pebax(R) 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
`
`BRIEF DESCRIPTION OF THE DRAWINGS
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`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 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 catheterand guidewire in a second position depicted
`in phantom;
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