(19) United States
`(12) Reissued Patent
`US RE46,116 E
`(10) Patent Number:
`Root et al.
`*Aug. 23, 2016
`(45) Date of Reissued Patent:
`
`USO0RE46116E
`
`(54) COAXIAL GUIDE CATHETER FOR
`INTERVENTIONAL CARDIOLOGY
`PROCEDURES
`
`USPC ........... 604/103.04, 103.9, 1607162, 164.01,
`604/164.02, 16409716411, 525
`See application file for complete search history.
`
`(71) Applicant: VASCULAR SOLUTIONS, INC.,
`Minneapolis, MN (US)
`
`(56)
`
`(72)
`
`Inventors: Howard C. Root, Tonka Bay, MN
`(US); Gregg Sutton, Plymouth, MN
`(US); Jeflrey M. Welch, Maple Grove,
`MN (US); Jason M. Garrity, Lima,
`NY (US)
`
`(73) Assignee: Vascular Solutions, Inc., Minneapolis,
`MN (US)
`
`( * ) Notice:
`
`This patent is subject to a terminal dis-
`claimer.
`
`(21) Appl. No.: 14/195,435
`
`(22)
`
`Filed:
`
`Mar. 3, 2014
`Related U.S. Patent Documents
`
`Reissue of:
`
`8,292,850
`Oct. 23, 2012
`13/359,059
`Jan. 26, 2012
`
`(64) Patent No.:
`Issued:
`Appl. No.:
`Filed:
`US. 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,
`
`References Cited
`U.S. PATENT DOCUMENTS
`
`4,289,128 A
`4,723,936 A
`
`9/1981 Rush
`2/1988 Buchbinder et a1.
`
`(Continued)
`
`FOREIGN PATENT DOCUMENTS
`
`EP
`EP
`
`0313558
`0365993
`
`l/l988
`5/1990
`
`(Continued)
`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 7 Catherine S Williams
`(74) Attorney, Agent,
`or Firm iPatterson Thuente
`Pedersen, P.A.
`
`(Continued)
`
`(57)
`
`ABSTRACT
`
`(5 1 )
`
`Int. Cl.
`A6IM 5/1 78
`A61M 25/00
`A61M 25/01
`(52) US. Cl.
`CPC ......... A61M 25/01 (2013.01); A61M 25/0069
`(2013.01)
`
`(2006.01)
`(2006.01)
`(2006.01)
`
`(58) Field of Classification Search
`CPC .................... A61M 25/0009; A61M 25/0069;
`A61M 25/0105; A61M 25/01; A61M 25/04;
`A61M 2025/015; A61M 25/0102; A61M
`25/0147; A61B 17/1204; A61B 17/12136;
`A61B 2017/00526; B29C 65/00
`
`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
`oiT 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.
`
`31 Claims, 13 Drawing Sheets
`
`
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`US RE46,116 E
`Page 2
`
`Related US. Application Data
`
`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. 11/416,629, filed on
`May 3, 2006, now Pat. No. 8,048,032.
`
`(56)
`
`References Cited
`U.S. PATENT DOCUMENTS
`
`4,762,129 A
`4,813,930 A
`4,832,028 A
`4,909,252 A
`4,932,413 A
`4,946,440 A
`4,994,745 A
`5,002,531 A
`5,098,412 A
`5,102,403 A
`5,120,323 A *
`
`5,122,125 A
`5,232,445 A
`5,234,416 A
`5,257,974 A
`5,328,472 A
`5,368,567 A
`5,441,489 A
`5,445,624 A
`5,472,425 A
`5,527,292 A *
`
`5,549,553 A
`5,599,326 A
`5,658,263 A
`5,690,613 A
`5,776,141 A
`5,792,124 A
`5,911,715 A
`5,980,486 A
`6,159,195 A
`6,193,686 B1
`
`8/1988 Bonzel
`3/1989 Elliott
`5/1989 Patel
`3/1990 Goldberger
`6/1990 Shockey et a1.
`8/1990 Hall
`2/1991 Mizuta
`3/1991 Bonzel
`3/1992 Shiu
`4/1992 Alt
`6/1992 Shockey ............... A61M 25/01
`600/434
`
`6/1992 Deuss
`8/1993 Bonzel
`8/1993 Macaulay et a1.
`11/1993 Cox
`7/1994 Steinke et a1.
`11/1994 Lee
`8/1995 Utsumi et a1.
`8/1995 Jimenez
`12/1995 Teirstein
`6/1996 Adams .............. A61M 25/0102
`600/585
`
`8/1996 Ressemann et a1.
`2/1997 Carter
`8/1997 Dang et a1.
`11/1997 Verbeek
`7/1998 Klein et a1.
`8/1998 Horrigan et a1.
`6/1999 Berg et a1.
`11/1999 Enger
`12/2000 Ha et a1.
`2/2001 Estrada et a1.
`
`6,338,725
`6,409,863
`6,475,195
`6,488,655
`6,503,223
`6,503,353
`6,548,010
`6,575,958
`6,591,472
`6,595,952
`6,610,068
`6,635,029
`6,638,268
`6,689,144
`6,706,018
`6,755,812
`6,860,876
`7,232,452
`7,294,124
`7,544,201
`7,697,996
`7,717,899
`7,762,984
`8,048,032
`8,142,413
`8,292,850
`2003/0195546
`2004/0010280
`
`2004/0127927
`2005/0004523
`2005/0182437
`2007/0260219
`
`B1
`B1
`B1
`B1
`B1
`B1
`B1
`B1
`B1
`B2
`B1
`B1
`B2
`B2
`B2
`B2
`B2
`B2
`B2
`B2
`B2
`B2
`B2
`B2
`B2
`B2
`A1
`A1
`
`A1
`A1
`A1
`A1
`
`>l<
`
`1/2002
`6/2002
`11/2002
`12/2002
`1/2003
`1/2003
`4/2003
`6/2003
`7/2003
`7/2003
`8/2003
`10/2003
`10/2003
`2/2004
`3/2004
`6/2004
`3/2005
`6/2007
`11/2007
`6/2009
`4/2010
`5/2010
`7/2010
`11/2011
`3/2012
`10/2012
`10/2003
`1/2004
`
`7/2004
`1/2005
`8/2005
`11/2007
`
`Hermann et a1.
`Williams et a1.
`Voda
`Wantink et a1.
`Sekido et a1.
`Peterson et a1.
`StiVland et a1.
`Happ et a1.
`Noone et a1.
`Forsberg
`Yang
`Venturelli
`Niazi
`Gerberding
`Westlund et a1.
`Peterson et a1.
`Chen
`Adams et a1.
`Eidenschink
`Pepper
`Manning et a1.
`Bowe et a1.
`Kumoyama et a1.
`Root et a1.
`Root et a1.
`Root et a1.
`Solar et a1.
`Adams ............. A61B17/12136
`606/194
`
`Adams
`Osborne et a1.
`Bonnette et a1.
`Root et a1.
`
`FOREIGN PATENT DOCUMENTS
`
`EP
`WO
`
`0380873
`WO84/03 633
`
`8/1990
`9/1984
`
`OTHER PUBLICATIONS
`
`U.S. Appl. No. 11/416,629, filed Jun. 28, 2010; Howard Root et al.
`US. Appl. No. 12/824,734, filed Jun. 28, 2010, Howard Root et a1.
`
`* cited by examiner
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`U.S. Patent
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`Aug. 23, 2016
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`Sheet 1 of 13
`
`US RE46,116 E
`
`
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`US RE46,116 E
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`US RE46,116 E
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`US RE46,116 E
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`US RE46,116 E
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`Fig. 5
`
`e
`
`14
`
`12
`
`50
`
`Fig. 6
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`52
`
`14
`
`1 2
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`US RE46,116 E
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`Fig. 7
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`US RE46,116 E
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`Fig. 8
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`58
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`US RE46,116 E
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`Fig. 9
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`58
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`US RE46,116 E
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`r20
`
`Fig.12
`
`h+
`
`Fig.1320f
`
`T>15
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`84
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`15
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`82
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`Fig.16 m
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`Fig.15 Q82
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`US RE46,116 E
`
`‘—
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`NJT.
`OI
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`US RE46,116 E
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`U.S. Patent
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`US RE46,116 E
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`

`1
`COAXIAL GUIDE CATHETER FOR
`INTERVENTIONAL CARDIOLOGY
`PROCEDURES
`
`US RE46,116 E
`
`2
`
`Matter enclosed in heavy brackets [ ] appears in the
`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
`indicates that the claim was canceled, disclaimed, or held 10
`invalid by a prior post-patent action or proceeding.
`
`RELATED APPLICATIONS
`
`20
`
`This application is a continuation reissue of application 15
`Ser. No. 14/070,161 which is an application for reissue of
`US. Pat. No. 8,292,850 which issuedfrom application Ser.
`No. 13/359, 059,filed Jan. 26, 2012 entitled “Coaxial Guide
`Catheterfor Interventional Cardiology Procedures” which
`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 Interventional Cardiology Procedures”,
`which is divisional of application Ser. No. 11/416,629, filed
`May 3, 2006 now U.S. Pat. No. 8,048,032 entitled “Coaxial 25
`Guide Catheter for Interventional Cardiology Procedures”
`now US. Pat. No. 8,142,413; Notice: more than one reissue
`application has been filedfor the reissue of US. Pat. No.
`8,292,850; the reissue application are application Ser. No.
`14/070,161, this application and continuation reissue appli— 30
`cation Ser. Nos. 14/195,385 and 14/195,413 filed Mar. 3,
`2014, the same day as this application.
`
`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
`coronary arteries from the aorta.
`
`BACKGROUND OF THE INVENTION
`
`35
`
`40
`
`Interventional cardiology procedures often include insert-
`ing guidewires or other instruments through catheters into 45
`coronary arteries that branch oif from the aorta. For the
`purposes of this application, the term “interventional cardi-
`ology 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 50
`may be narrowed 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 55
`commonly necessary to pass a guidewire or other instru-
`ments 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 60
`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 instru-
`ment 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
`Immehe) ggi4q catheter from the ostium of the artery
`
`65
`
`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 issued
`to Dang et al. These guiding catheters all share the common
`limitation that a guide catheter stiif enough to provide
`adequate backup support
`is often too stiif 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 interfere 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 tension to stiifen a bend in the catheter to provide
`backup support. 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 a thera-
`peutic 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 Bon-
`nette 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
`provide 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 Car-
`diovascular Interventions, 63:452-456 (2004). This tech-
`nique 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. Unfortunately, deep seating by this technique
`with a commonly available guide catheter creates the risk
`that the relatively stiif,
`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.
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`US RE46,116 E
`
`3
`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 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 sup-
`port by providing the ability to effectively create deep
`seating in the ostium of the coronary artery.
`
`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 pref-
`erably includes a tapered inner catheter that runs over a
`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 pro-
`vides a gradual
`transition from the standard 0.014 inch
`diameter guidewire to the diameter 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
`delivering 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
`commonly 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 catheter 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 tech-
`nique. Therefore, one embodiment of the coaxial guide
`catheter of the present
`invention includes a radiopaque
`marker at its distal tip to facilitate positioning and manipu-
`lation of the coaxial guide catheter.
`The present invention generally includes the coaxial guide
`catheter and a tapered inner catheter. The coaxial guide
`catheter includes a tip portion, a reinforced portion, and a
`substantially rigid portion. The coaxial guide catheter will
`generally have an overall length of preferably approximately
`Ipfimmggzms should not be considered limiting.
`
`10
`
`15
`
`20
`
`25
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`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`4
`
`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®)
`the marker band may be formed from a platinum iridium
`alloy sandwiched 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
`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
`circumference portion. For example, the cutout portion may
`include a section where about 45% of the circumference of
`
`tubular structure has been removed. The
`the cylindrical
`cutout portion may also include a section where 75-90% of
`the circumference of the tubular structure has been removed.
`
`In one exemplary embodiment, the portion having approxi-
`mately 45% removed may extend for approximately 75 cm
`and the portion having 75-90% of the structure removed
`extends for about 15 cm.
`
`The full circumference portion of the rigid portion is
`typically located at the most proximal end of the coaxial
`guide catheter.
`The rigid portion may include a plurality of radially
`oriented 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 typi-
`cally at the mo st distal end of the tapered inner catheter. Both
`the straight portion and the tapered portion are pierced by a
`lumen through which a guidewire may be passed.
`The cutout portion supports a track passing along the
`concave 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 commu-
`nicates with the aorta. The coaxial guide catheter-tapered
`inner catheter combination may be threaded over a pre-
`placed 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 sufficiently 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
`treatment device, such as a guidewire, balloon or stent, may
`eter wit
`I'Ol’llC 31%th45
`be passed through the coaxial guidR/lceat
`Medtronic v. Teleflex
`
`Page 17 of 26
`
`IPR2020-01341
`
`Medtronic Ex-1845
`Medtronic v. Teleflex
`Page 17 of 26
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`

`

`US RE46,116 E
`
`5
`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 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 of from a larger artery is subject to
`force vectors that tend to dislodge the distal end of the guide
`catheter from the ostium of the branch artery when a
`physician attempts to direct a guidewire or other interven-
`tional cardiology 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 interventional 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 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 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 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 inven-
`tion 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 uti-
`lizing currently available equipment. The present invention
`also allows atraumatic placement within the coronary artery.
`Further,
`the invention is deliverable through an existing
`hemostatic valve arrangement on a guide catheter without
`preventing 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
`vessel.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 is a schematic depiction of the coaxial guide
`catheter 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
`IPIRSEGZWQIFQW l
`
`6
`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 of a guide catheter, a guide-
`wire, a coaxial guide catheter in accordance with the present
`invention 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.
`
`10
`
`15
`
`20
`
`25
`
`FIG. 16 is a sectional view of the rigid portion taken along
`section line 16-16 of FIG. 13.
`
`30
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`FIG. 17 is a plan view of a coaxial guide catheter having
`a longer rail segment and a tapered inner catheter in accor-
`dance 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
`catheter taken along section lines 19-19 of FIG. 18.
`FIG. 20 is a plan view of a coaxial guide catheter in
`accordance 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 approxi-
`mately 125 cm. This length should not be considered lim-
`iting.
`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 location may be formed of 5533 Pebax, for example.
`Reinforced portion 18 includes braid or coil reinforce-
`ment 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®
`material 28. Tip portion 16 and reinforced portion 18
`together form a substantially cylindrical structure. Braid or
`coil reinforcement 32 may extend amflfiatefiyg )t(o_ 13%45
`Medtronic v. Teleflex
`
`Page 18 of 26
`
`IPR2020-01341
`
`Medtronic Ex-1845
`Medtronic v. Teleflex
`Page 18 of 26
`
`

`

`US RE46,116 E
`
`7
`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 rein-
`forcement 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 circumference 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
`circumference of the tube. Arcuate portion 38 may extend
`linearly, 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 of a guide wire to
`the diameter of tip portion 16.
`Tapered inner catheter tip 42 includes tapered portion 46
`at 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 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 inner cath-
`eter 14 to coaxial guide catheter 12. Thus, tapered inner
`catheter 14 is keyed to coaxial guide catheter 12.
`its
`Coaxial guide catheter 12 may include, starting at
`distal end, a first portion having a flexural modulus of about
`13,000 PSI plus or minus 5000 PSI, a second portion having
`a flexural 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 portion of braid or coil reinforcement 32. Next may
`come an approx