BSC USP 8,048,032
`Exhibit 1002
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`Page 1 of 453
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`CERTIFICATE OF CORRECTION
`
`PATENT NO. (cid:9)
`APPLICATION NO. (cid:9)
`DATED (cid:9)
`INVENTOR(S) (cid:9)
`
`: 8,048,032 B2
`: 11/416629
`: November 1, 2011
`: Root et al.
`
`Page 1 of 1
`
`It is certified that error appears in the above-identified patent and that said Letters Patent is hereby corrected as shown below:
`
`On the Title Page:
`
`The first or sole Notice should read --
`
`Subject to any disclaimer, the term of this patent is extended or adjusted under 35 U.S.C. 154(b)
`by 444 days.
`
`Signed and Sealed this
`Thirty-first Day ofJanuary, 2012
`
`David I linppos
`Director of the United States Parent and Trademark Office
`
`VSI_00000001
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`A01333
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`(cid:9)
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`Page 2 of 453
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`UNITED STATES PATENT AND TRADEMARK 0
`
`Commissioner for Patents
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`virmv uspto gov
`
`PATTERSON THUENTE CHRISTENSEN
`PEDERSEN PA
`4800 IDS CENTER
`80 SOUTH 8TH STREET
`MINNEAPOLIS MN 55402-2100
`
`MAILED
`NOV 2 8 2011
`OFFICE OF PETITIONS
`
`In re Patent No. 8,048,032
`Root, et al.
`Issue Date: November 1, 2011
`Application No. 11/416,629
`Filed: May 3, 2006
`Attorney Docket No. 2005.86US01
`
`DECISION ON
`PATENT TERM ADJUSTMENT
`AND NOTICE OF INTENT
`TO ISSUE
`CERTIFICATE OF
`CORRECTION
`
`This is a decision on the "PETITION UNDER 37 C.F.R. 1.705(d)",
`filed November 10, 2011. Patentees request that the patent term
`adjustment indicated on the patent be corrected from four hundred
`thirty-seven (437) days to four hundred forty-four (444) days.
`
`The petition is GRANTED.
`
`The patent term adjustment indicated on the patent is to be
`corrected by issuance of a certificate of correction showing a
`revised Patent Term Adjustment of four hundred forty-four (444)
`days.
`
`On November 1, 2011, the above-identified application matured
`into U.S. Patent No. 8,048,032. Patentees timely filed the
`instant application for patent term adjustment under 37 CFR
`1.705(d) on November 10, 2011. Patentees assert that they should
`not have been assessed applicant delay of seventy-six (76) days
`for the submission of an IDS on August 18, 2011 and replacement
`drawings on September 22, 2011, after the Notice of Allowance was
`mailed on August 3, 2011 and a supplemental Notice of
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`Page 3 of 453
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`Patent No. 8,048,032 (cid:9)
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`Page 2
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`Allowability was mailed on September 14, 2011. Rather, Patentees
`assert that they should have only been assessed applicant delay
`of twenty-eight (28) and forty-one (41) days for these two
`submissions under 37 CFR 1.704(c)(10).
`
`37 CFR 1.704(c)(10) states that applicant delay shall be assessed
`"beginning on the date the...paper was filed and ending on the
`mailing date of the Office action or notice in response to the...
`paper". Here, Applicant filed an IDS on August 18, 2011, and the
`Office mailed a response (a Notice of Allowability) on
`September 14, 2011. Accordingly, Applicants should have been
`accorded 28 days of delay for this filing. In addition,
`Applicants filed replacement drawings on September 22, 2011. The
`Office did not mail a response until the patent issued on
`November 1, 2011. As such, 41 days of Applicant delay should
`have been assessed for this submission. The total assessment of
`76 days for these two filings is incorrect. Rather, the total
`delay should have been 69 (28+41) days.
`
`In view thereof, the correct determination of PTA at the time of
`issuance is four hundred forty-four (444) days (416 days of "A"
`delay and 129 days of "B" delay, reduced by 101 (32+28+41) days
`of applicant delay.
`
`Receipt of the $200.00 fee set forth in 37 CFR §1.18(e) is
`acknowledged.
`
`The application is being forwarded to the Certificates of
`Correction Branch for issuance of a certificate of correction in
`order to rectify the error regarding the patent term information.
`See 35 U.S.C. § 254 and 37 C.F.R. § 1.322. The certificate of
`correction will indicate that the term of the above-identified
`patent is extended or adjusted by four hundred forty - four (444)
`days subject to any disclaimers.
`
`Telephone inquiries specific to this matter should be directed to
`the undersigned at (571)272- 207.
`
`Cliff Congo
`Petitions Attorney
`Office of Petitions
`
`Enc: draft certificate of correction
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`DRAFT CERTIFICATE OF CORRECTION
`: 8,048,032 B2
`PATENT (cid:9)
`
`DATED (cid:9)
`
`: November 1, 2011
`
`INVENTOR(S) : Root et al.
`
`It is certified that error appears in the above-identified patent and that said Letters
`Patent is hereby corrected as shown below:
`
`On the cover page,
`
`Subject to any disclaimer, the term of this patent is extended or adjusted
`[*] Notice: (cid:9)
`under 35 USC 154(b) by 437 days.
`
`Delete the phrase "by 437 days" and insert — by 444 days--
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`Page 5 of 453
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`PATENT APPLICATION
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re the application of: (cid:9)
`
`Attorney Docket No.: 2005.86US01
`
`Howard Root et al. (cid:9)
`
`Application No.: (cid:9)
`
`11/416,629 (cid:9)
`
`Filed: (cid:9)
`
`May 3, 2006 (cid:9)
`
`Confirmation No.: 5061
`
`Examiner: Bradley James Osinski
`
`Group Art Unit: 3767
`
`For: COAXIAL GUIDE CATHETER FOR INTERVENTIONAL CARDIOLOGY
`PROCEDURES
`
`PETITION UNDER 37 C,F.R. § 1.705(d)
`
`Mail Stop Petition
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Sir:
`
`1. Applicant hereby petitions under 37 CFR § 1.705(d) that the patent term adjustment for
`
`U.S. Patent No. 8,048,032 be changed from 437 days to 444 days, in accordance with the
`
`requirements of justice.
`
`STATEMENT OF FACTS
`
`2. U.S. Patent No. 8,048,032 ("the '032 Patent") issued to inventors Howard Root et al., on
`
`November 1, 2011. The patent term adjustment, as determined by the USPTO under 35
`
`USC § 154(b), and listed on the face of the '032 patent is 437 days. This patent is not
`
`subject to a terminal disclaimer. A copy of the '032 patent is attached as Attachment A.
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`Application No. 11/416,629
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`3. The USPTO's determination of 437 days of patent terra adjustment is in error in that the
`
`USPTO failed to properly account for the Supplemental Information Disclosure
`
`Statement submitted by Applicant on August 18, 2011 and submission of replacement
`
`drawings after the Notice of Allowance issued August 3, 2011, pursuant to 37 CFR
`
`1.704(c)(10). See Attachment B comprising a hardcopy of the USPTO PTA calculation
`
`from the PAIR system.
`
`4. Applicant submitted a Supplemental Infoiniation Disclosure Statement on August 18,
`
`2011 after the Notice of Allowance of August 3, 2011.
`
`5. The PTO issued a Supplemental Notice of Allowability on September 14, 2011,
`
`responding to the August 18, 2011 Supplemental Information Disclosure Statement in
`
`which the Examiner indicated that all references disclosed in the Supplemental
`
`Information Disclosure Statement were considered.
`
`6. Applicant submitted replacement drawings September 22, 2011.
`
`7. The replacement drawings were deemed considered as of the issue date of the patent
`
`November 1, 2011.
`
`8. Under 37 CFR 1.704(c)(10), the period of adjustment is reduced where an applicant
`
`submits an amendment under 37 CFR 1.132 or other paper after a notice of allowance has
`
`been given or mailed, ( ) for the period beginning on the date the amendment or other
`
`paper was filed and ending on the mailing date of the Office action or notice in response
`
`to the amendment or such other paper; or (ii) 4 months, whichever is less.
`
`2
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`9. As Applicants' August 18, 2011 Supplemental Information Disclosure Statement was
`
`filed after the Notice of Allowance, Applicant should have been debited 28 days since the
`
`Amendment was considered in the September 14, 2011 Supplemental Notice of
`
`Application No. 11/416,629
`
`Allowability.
`
`10. As Applicants' replacement drawings were deemed considered November 1, 2011 (the
`
`date the patent issued) Applicants should have been debited 41 days. As determined by
`
`the USPTO, there are believed to be no additional circumstances during prosecution of
`
`this application that constitute a failure to engage in reasonable efforts to conclude
`
`processing or examination as set forth in § 1.704. See Attachment B.
`
`11. The USPTO's PTA calculation in PAIR indicates that the Applicant was debited 76 days
`
`for submission of the Supplemental Information Disclosure of August 18, 2011 and the
`
`submission of replacement drawings, rather than the 69 (28+41) days of debit believed
`
`appropriate by the Applicant. Accordingly, Applicant believes that this resulted in 7 days
`
`of excessive reduction to Applicant's PTA award.
`
`12. Therefore, the correct patent term adjustment is 444 days once the days of excessive
`
`reduction are properly taken into account.
`
`13. The Applicants' credit of only 437 days of patent term adjustment for the '032 patent is
`
`arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law and
`
`in excess of statutory jurisdiction, authority or limitation.
`
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`14. Accordingly, Applicants' and the undersigned respectfully submit that justice requires
`
`that the patent term adjustment credited to U.S. Patent No. 8,048,032 be changed from
`
`Application No. 11/416,629
`
`437 days to 444 days.
`
`Electronic payment is submitted by credit card to cover the fee. Please credit or debit
`
`Deposit Account No. 16-0631 as needed to ensure consideration of the disclosed information.
`
`Paul C. Onderick
`Registration No. 45354
`
`Customer No. 24113
`Patterson Thuente Christensen Pedersen, P.A.
`4800 IDS Center
`80 South 8th Street
`Minneapolis, Minnesota 55402-2100
`Telephone: 612.349.5766
`
`4
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`ATTACHMENT A
`
`1111111111111111111!1111111Q111111111111111111111111111
`
`(12) United States Patent (cid:9)
`Root et al. (cid:9)
`
`(10) Patent No.: (cid:9)
`(45) Date of Patent: (cid:9)
`
`US 8,048,032 B2
`Nov. 1, 2011
`
`(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: (cid:9)
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 437 days.
`
`12/2000 Ha et al.
`6,159,195 A (cid:9)
`6,338,725 B1 (cid:9) • 1;2002 Hermann et al. (cid:9)
`11/2002 Voda
`6,475,195 B1 (cid:9)
`6,595,952 B2 (cid:9)
`7/2003 Forsberg
`6,610,068 131 (cid:9)
`8/2003 Yang
`
`6,638,268 B2 (cid:9) • 10/2003 Niazi (cid:9)
`6,689,144 B2 (cid:9)
`2/2004 Gerberding
`6,706,018 B2 (cid:9)
`3/2004 Westlund ct al.
`6/2004 Peter sou et al.
`6,755,812 B2 (cid:9)
`6,860,876 B2 (cid:9)
`3/2005 (Then
`7,697,996 112 (cid:9)
`4/2010 Manning et al.
`7,717,899 B2 (cid:9)
`5/2010 Bowe et al.
`2003/0195546 Al (cid:9) • 10/2003 Solar ct al. (cid:9)
`2004/0127927 Al (cid:9) • 7/2004 Adams
`2005/0004523 At (cid:9)
`1/2005 Osborne et al.
`2005/0182437 Al (cid:9)
`8/2005 Bonnette et al.
`2007/0260219 Al (cid:9)
`11/2007 Root et al.
`
`OTHER PUBLICATIONS
`
` 604/95,04
`
` 604/528
`
` 606/192
` 606/170
`
`(21) Appl. No.: 11/416,629
`
`(22) Filed: (cid:9)
`
`May 3, 2006
`
`(65)
`
`Prior Publication Data
`
`US 2007/0260219 Al (cid:9)
`
`Nov. 8, 2007
`
`(51)
`
`Int. CI.
`A6IM 5/178 (cid:9)
`(2006.01)
`(2006.01)
`A61M 25/00 (cid:9)
` 604/164.1; 604/525
`(52) U.S. Cl. (cid:9)
`(58) Field of Classification Search ............. 604/103.04,
`604/103.09, 160-162, 164.01, 164.09-164.11,
`604/525, 164.02
`See application file for complete search history.
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`A
`3/1989
`Elliott
`A
`5/1989
`Patel
`A
`6/1990
`Shockey et al.
`A
`3/1992
`Shiu
`A
`6/1992
`Deuss
`A
`12/1995
`Teirstein
`A
`8/1997
`Dang et al.
`A •
`7/1998
`Klein et al. (cid:9)
`
`4,813,930
`4,832,028
`4,932,413
`5,098,412
`5,122,125
`5,472,425
`5,658,263
`5,776,141
`
`Takahashi, New Method to Increase a Backup Support of a 6 French
`Guiding Coronary Catheter, Catheterization and Cardiovascular
`Interventions 63A52-456 (2004), 5 pages, published online in Wiley
`InterScience (www.interscience.wiley.com).
`Office Action for U.S. Appl. Nu. 12/824,734; filed Jun. 28, 2010,
`Inventors Roots at al.; Office Action dated Aug. 1, 2011.
`
`* cited by examiner
`
`Primary Examiner — Jackie Ho
`Assistant Examiner — Bradley Osinski
`(74) Attorney, Agent, or Firm — Patterson Thuente IP
`
`(57) (cid:9)
`
`ABSTRACT
`
`A coaxial guide catheter to be passed through guide catheter
`having a first lumen, for use with interventional cardiology
`devices that are insertable into a branch artery that branches
`off from a main artery. The coaxial guide catheter is extended
`through the lumen of the guide catheter and beyond the distal
`end of the guide catheter and inserted into the branch artery.
`The device assists in resisting axial and shear forces exerted
`by an interventional cardiology device passed through the
`second lumen and beyond the flexible distal tip portion that
`would otherwise tend to dislodge the guide catheter from the
`branch artery.
`
` 623/1.11
`
`22 Claims, 13 Drawing Sheets
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`VSI_00000009
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`(cid:9)
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`(cid:9)
`(cid:9)
`(cid:9)
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`1
`COAXIAL GUIDE CATHETER FOR
`INTERVENTIONAL CARDIOLOGY
`PROCEDURES
`
`FIELD OF THE INVENTION
`
`5
`
`The present invention relates generally to catheters used in
`interventional cardiology procedures. More particularly the
`present invention relates to methods and apparatus for
` to
`increasing backup support for catheters inserted into the coro-
`nary arteries from the aorta.
`
`BACKGROUND OF THE INVENTION
`
` 15
`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 20
`guidewires, balloon catheters, stents and stent catheters. In
`coronary artery disease the coronary arteries may he 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 25
`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 30
`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 35
`into the artery beyond the occlusion or stenosis. Crossing
`tough lesions can create enough backward force to dislodge
`the guide catheter from the ostium of the artery being treated.
`This can make it difficult or impossible for the interventional
`cardiologist to treat certain forms of coronary artery disease. 40
`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 45
`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 SO
`guiding catheters all share the common limitation that a guide
`catheter stiff enough to provide adequate backup support is
`often too still' 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 co
`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. as
`Nos. 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.
`
`2
`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 ostiuin of the
`coronary artery to provide a force acting in opposition to the
`backward forces created when trying to maneuver a therapeu-
`tic device past a lesion or blockage in the coronary artery.
`These devices can include a balloon secured to a guidcwire or
`a catheter or another device for expanding to grip the walls of
`the coronary artery from within. Examples of this approach
`may be found in U.S. Pat. Nos. 4,832,028 issued to Patel; 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 lbr 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
`most 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 support by
`providing the ability to effectively create deep seating in the
`ostium of the coronary artery.
`
`SUMMARY OF THE INVENTION
`
`"lbe present invention a coaxial guide catheter that
`
`
`deliverable through standard guide catheters by utilizing
`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 over a standard
`0.014 inch coronary guidewire to allow atrauma tic 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
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`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 5
`least three sires corresponding to the internal capacity of It
`French, 7 French, and 6 French guide catheters that arc 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 t u
`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 15
`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
`distal tip to facilitate positioning and manipulation of the 25
`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- 30
`erally have an overall length of preferably approximately I 25
`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 35
`polyether block amide polymer, (PEBA, Pebax®) the marker
`band may be formed from a platinum iridium alloy sand-
`wiched between the Pebax® that extends front the bump tip
`and a PT FE liner.
`In one embodiment, the reinforced portion may be rein- 40
`forced, preferably with metallic fibers in a braided or coiled
`pattern. The braided or coiled portion is lined by a PTFF, 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 45
`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- 50
`fereuce 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- 55
`plary embodiment, the portion having approximately 45%
`removed may extend for approximately 75 cm and the portion
`having 75-90% of the structure removed extends for about 15
`cm. The full circumference portion of the rigid portion is
`typically located at the most proximal end in f the coaxial guide 60
`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 65
`generally includes a tapered inner catheter tip and a cutout
`portion. The tapered inner catheter tip includes a tapered
`
`4
`portion and a straight portion. The tapered portion is typically
`at the most distal end of the tapered inner catheter. Both the
`straight portion and the tapered portion are pierced by a lumen
`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 re leasab ly 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
`the ostium of the coronary artery while directing the coronary
`therapeutic device past a tough lesion such as a stenosis or a
`chronic arterial occlusion.
`A guide catheter inserted into the ostium of a branch artery
`where it branches off from a larger artery is subject to force
`vectors that tend to dislodge the distal end of the guide cath-
`eter from the ostium of the branch artery when a physician
`attempts to direct a guidewire or other interventional cardi-
`ology device past an occlusive or stenotic lesion in the branch
`artery. This discussion will refer to a guide wire but it is to be
`understood that similar principles apply to other interven-
`tional cardiology devices including balloon catheters and
`stent catheters.
`One of the forces that acts on the guide catheter is an axial
`force substantially along the axis of the branch artery and the
`portion of the guide catheter that is seated in the ostium. This
`force vector is a reactive force created by the pushing back of
`the guide wire against the guide catheter as the physician tries
`to force the guidewire through or past the lesion. It tends to
`push the distal end of the catheter out of the ostium in a
`direction parallel to the axis of the branch artery and the axis
`of the distal end of the guide catheter.
`Another of the force vectors that acts on the guide catheter
`is a shearing force that tends to dislodge the distal end of the
`guide catheter from the ostium of the branch artery in a
`direction perpendicular to the axis ofthe branch artery and the
`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
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`resisting both the a xial fortes 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 5
`allows atraumatic placement within the coronary artery. Fur-
`ther, the invention is deliverable through an existing hemo-
`static valve arrangement ou a guide catheter without prevent-
`ing injections through existing Y adapters. Finally, the
`invention has an inner diameter acceptable for delivering to
`standard coronary devices after it is placed in the blood ves-
`sel.
`
`BRIEF DESCRIPTION OF THE. DRAWINGS
`
`15
`
`6
`FIG. 22 is a cross-sectional view -taken along section line
`22-22 of FIG. 21.
`
`DETAILED DESCRIPTION OF THE INVENTION
`
`Referring to FIGS. 1 and 2, coaxial guide catheter assem-
`bly 10 of the present invention generally includes coaxial
`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
`hand 24. Rump tip 22 includes taper 26. Rump 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
`platimm3iridium 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-
`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® material 28.
`Tip portion 16 and reinforced portion 18 t